Form 6-K NOVARTIS AG For: Dec 31
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 or 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
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Report on Form 6-K dated
January 27, 2015
(Commission File No. 1-15024)
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Novartis AG
(Name of Registrant)
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Lichtstrasse 35
4056 Basel
Switzerland
(Address of Principal Executive Offices)
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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
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Form 20-F: x
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Form 40-F: o
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
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Yes: o
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No: x
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
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Yes: o
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No: x
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Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
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Yes: o
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No: x
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SIGNATURES
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Novartis AG
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Date:
January 27, 2015
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By:
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/s/ MALCOLM B. CHEETHAM
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Name:
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Malcolm B. Cheetham
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Title:
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Head Group Financial Reporting and Accounting
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Novartis�International�AG
Novartis�Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
http://www.novartis.com
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FINANCIAL RESULTS���"���R�SULTATS FINANCIERS���"���FINANZERGEBNISSE
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Novartis delivered solid sales growth, margin expansion and pipeline progress in 2014; portfolio transformation will focus company on leading businesses
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Net sales grew in FY 2014, with strong core1 margin expansion
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Net sales increased 1% (+3% cc1)2 to USD 58.0 billion in FY (Q4: -2%, +4% cc)
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Operating income grew 1% (+7% cc) to USD 10.7 billion in FY
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Net income up 12% (+19% cc) to USD 10.3 billion in FY
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Core operating income in FY (+3%, +8% cc) drove 120 basis points of core margin expansion (cc)
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Core EPS was USD 5.23 (+4%, +10% cc) in FY
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Free cash flow1 was USD 10.8 billion (+12%) in FY
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Strong innovation momentum continues from Q4
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Cosentyx approved in US and EU for psoriasis; in Japan for psoriasis and psoriatic arthritis
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Signifor long-acting release formulation approved in US and EU for acromegaly
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Files submitted for LCZ696 in US and EU, and for QVA149 and NVA237 in US
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FDA Advisory Committee recommended approval for Sandoz biosimilar filgrastim
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Growth Products3 and Emerging Growth Markets3 continued to drive performance in Q4
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Growth Products grew 14% (USD) to USD 4.7 billion, or 32% of Group net sales
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Strong performance in Emerging Growth Markets (+12% cc)
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Continued progress in transforming portfolio and increasing productivity
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Divestment of Animal Health Division to Eli Lilly and Company completed on January 1, 2015
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Implementation of Novartis Business Services on track
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Core margin (+1.2 percentage points cc) improved mainly due to ongoing productivity initiatives
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Dividend of CHF 2.60 per share, up 6%, proposed for 2014
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Outlook 2015 for continuing operations:
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Net sales expected to grow mid-single digit (cc); core operating income expected to grow ahead of sales at a high-single digit rate (cc)
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Outlook based on modeling assumption that GSK transactions will close on March 31, 20154
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Key figures
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excl. Diagnostics1
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Reported
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excl. Diagnostics1
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Reported
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| � | � | � | � | Q4 2014 | 5 | � | � | Q4 2013 | � | � |
% change
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FY 20145
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FY 2013
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Net sales
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� | � | � | 14 633 | � | � | � | 14 926 | � | � | � | -2 | � | � | � | 4 | � | � | � | 15 078 | � | � | � | 57 996 | � | � | � | 57 355 | � | � | � | 1 | � | � | � | 3 | � | � | � | 57 920 | � |
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Operating income
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� | � | � | 1 172 | � | � | � | 2 278 | � | � | � | -49 | � | � | � | -39 | � | � | � | 2 373 | � | � | � | 10 736 | � | � | � | 10 671 | � | � | � | 1 | � | � | � | 7 | � | � | � | 10 910 | � |
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Net income
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� | � | � | 1 487 | � | � | � | 1 999 | � | � | � | -26 | � | � | � | -16 | � | � | � | 2 058 | � | � | � | 10 280 | � | � | � | 9 144 | � | � | � | 12 | � | � | � | 19 | � | � | � | 9 292 | � |
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EPS (USD)
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� | � | � | 0.62 | � | � | � | 0.81 | � | � | � | -23 | � | � | � | -13 | � | � | � | 0.83 | � | � | � | 4.21 | � | � | � | 3.70 | � | � | � | 14 | � | � | � | 20 | � | � | � | 3.76 | � |
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Free cash flow
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� | � | � | 4 419 | � | � | � | 3 130 | � | � | � | 41 | � | � | � | � | � | � | � | 3 319 | � | � | � | 10 762 | � | � | � | 9 592 | � | � | � | 12 | � | � | � | � | � | � | � | 9 945 | � |
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Core
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� | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � |
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Operating income
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� | � | � | 3 322 | � | � | � | 3 293 | � | � | � | 1 | � | � | � | 9 | � | � | � | � | � | � | � | 14 616 | � | � | � | 14 191 | � | � | � | 3 | � | � | � | 8 | � | � | � | � | � |
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Net income
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� | � | � | 2 914 | � | � | � | 2 892 | � | � | � | 1 | � | � | � | 9 | � | � | � | � | � | � | � | 12 755 | � | � | � | 12 351 | � | � | � | 3 | � | � | � | 8 | � | � | � | � | � |
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EPS (USD)
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� | � | � | 1.21 | � | � | � | 1.18 | � | � | � | 3 | � | � | � | 12 | � | � | � | � | � | � | � | 5.23 | � | � | � | 5.01 | � | � | � | 4 | � | � | � | 10 | � | � | � | � | � |
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1 Constant currencies (cc), core results, free cash flow and 2013 data excluding the blood transfusion diagnostics unit are non-IFRS measures. An explanation of non-IFRS measures can be found on page 54 of the Condensed Financial Report (CFR).
2 All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 85 of the CFR.
3 Growth Products are defined on page 2, and Emerging Growth Markets are defined on page 9.
4 Forecast assumption for modeling purposes only. Novartis continues to expect the GSK transactions to be completed in the first half of 2015.
5 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date. See page 22 of the CFR.
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Basel, January 27, 2015 Commenting on the results, Joseph Jimenez, CEO of Novartis, said:
2014 was a transformational year for Novartis. We improved our execution, while taking steps to focus the company on our three leading businesses with global scale. We delivered solid sales growth with margin expansion, strengthened innovation, and advanced our quality and productivity agendas. Im confident that we are positioned for future success.
GROUP REVIEW
Following the announcement of the transactions with GlaxoSmithKline plc (GSK) and Eli Lilly and Company (Lilly) on April 22, 2014 (and the subsequent transaction with CSL Limited), in order to comply with International Financial Reporting Standards (IFRS), Novartis separated the Groups reported financial data for the current and prior years into discontinuing operations and continuing operations.1 See page 22 of the Condensed Financial Report for full explanation.
Fourth quarter
Group net sales grew on strong execution of Growth Products2
Group net sales amounted to USD 14.6 billion (-2%, +4% cc) in the fourth quarter. Growth Products contributed USD 4.7 billion or 32% of Group net sales, up 14% (USD) over the prior-year quarter.
Group operating income decreased 49% (-39% cc) to USD 1.2 billion, mainly due to an exceptional pre-tax impairment charge of USD 1.1 billion related to the pending divestment to CSL Limited (CSL) of the influenza vaccines business. Currency had a negative impact of 10 percentage points, primarily due to the weakening of the euro, yen and ruble against the US dollar. Operating income margin decreased to 8.0% of net sales, down 6.4 percentage points (cc) from the prior-year quarter mainly on account of the exceptional influenza vaccines business impairment charge. Currency had a negative impact of 0.9 percentage points, resulting in a net decrease of 7.3 percentage points. The cessation of depreciation and amortization charges related to the discontinuing operations had a positive impact of USD 101 million for the quarter, improving the operating income margin by 0.7 percentage points (cc). The adjustments made to Group operating income to arrive at core operating income increased to USD 2.2 billion (2013: USD 1.0 billion).
Core operating income increased 1% (+9% cc) to USD 3.3 billion. Core operating income margin in constant currencies increased 1.1 percentage points mainly due to lower functional costs driven by productivity programs, partly offset by unfavorable other income and expense. The cessation of depreciation and amortization charges related to the discontinuing operations had a positive impact of USD 49 million, improving the core operating income margin by 0.3 percentage points (cc). Currency had a negative impact of 0.5 percentage points, resulting in a net increase of 0.6 percentage points to 22.7% of net sales.
Group net income of USD 1.5 billion was down 26% (-16% cc), mainly due to lower operating income, partially offset by higher income from associated companies, which included a USD 0.4 billion pre-tax gain from the divestment of the shareholding in LTS Lohmann Therapie-Systeme AG and lower tax expense.
EPS was USD 0.62 (-23%, -13% cc), down slightly less than net income due to lower average outstanding shares and lower minority interest.
Group core net income of USD 2.9 billion was up 1% (+9% cc), in line with core operating income.
Core EPS was USD 1.21 (+3%, +12% cc), growing ahead of core net income mainly due to lower average outstanding shares and lower minority interest.
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1 Despite the required presentation of discontinuing operations, until the GSK and CSL transactions are closed, Novartis remains fully committed to all Group activities.
2 "Growth Products" comprise products launched in 2009 or later, or products with exclusivity until at least 2018 in key markets (EU, US, Japan) (except Sandoz, which includes only products launched in the last 24 months).
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Free cash flow for the fourth quarter was USD 4.4 billion, an increase of 41% or USD 1.3 billion compared to the prior-year period. This was primarily due to higher cash flows from operating activities, which mainly benefited from higher hedging gains and lower net working capital. Higher proceeds from Novartis Venture Fund divestments and lower investment in property, plant and equipment also contributed.
Comparing results for the fourth quarter of 2014 and the same period in 2013 including the blood transfusion diagnostics unit, Group total net sales decreased 3% in USD (+3% cc), Group total operating income was down 51% (-42% cc), Group total net income decreased 28% (-18% cc), and Group total EPS decreased 25% (-16% cc), down slightly less than Group total net income due to the lower average number of outstanding shares and lower minority interest.
Continuing operations
For continuing operations, net sales were USD 13.1 billion (-2%, +3% cc) in the fourth quarter. Operating income was up 1% (+10% cc), core operating income decreased 2% in USD (+6% cc) and core operating income margin increased 0.1 percentage points to 24.7% of net sales. Continuing operations do not yet include the results from oncology net assets to be acquired from GSK on closing of the transaction or the results from the 36.5% interest in the GSK/Novartis consumer healthcare joint venture that will be created at the same time.
Pharmaceuticals net sales were USD 7.9 billion (-6%, 0% cc), with volume growth of 8 percentage points offset by the negative impact of generic competition (-8 percentage points), largely for Diovan monotherapy and Exforge (US generic entry for Exforge on September 30, 2014 and for Exforge HCT on December 1, 2014). Growth Products generated USD 3.6 billion of division net sales, growing 18% (cc) over the same period last year. These products which include Gilenya, Afinitor, Tasigna, Galvus, Lucentis, Xolair, the COPD (chronic obstructive pulmonary disease) portfolio1 and Jakavi contributed 46% of division net sales, compared to 39% in the 2013 quarter.
Operating income of USD 1.6 billion (-20%, -14% cc) declined principally due to exceptional items, including net impairments of USD 157 million (primarily related to DEB025, which was terminated as a result of a hepatitis C virus strategy review) and net restructuring charges of USD 207 million (mainly related to a voluntary retirement program in Japan). Core operating income was USD 2.0 billion (-7%, 0% cc). Core margin in constant currencies was in line with the prior year; currency had a negative impact of 0.4 percentage points, resulting in a core margin of 25.2% of net sales.
Alcon�net sales were USD 2.7 billion (+2%, +7% cc) in the fourth quarter, led by robust growth in the Ophthalmic Pharmaceuticals and Surgical franchises. Emerging Growth Markets grew strongly (+7%, +17% cc), offset by weaker growth in Japan. Ophthalmic Pharmaceuticals grew (+4%, +10% cc), driven by double-digit growth in the glaucoma franchise, Systane and Ilevro. Surgical performance (+1%, +7% cc) benefited from strong sales of the Centurion�phacoemulsification cataract platform, with improving growth performance in AcrySof intraocular lenses. Vision Care (0%, +4% cc) was driven by strong growth of Dailies Total1 and AirOptix Colors, offset by a decline in contact lens care solutions.
Operating income increased 112% (+155% cc) to USD 365 million, driven by strong operating performance and the ending in 2013 of integration charges related to the acquisition of Alcon. Core operating income advanced 5% (+14% cc) to USD 895 million, driven by higher sales and productivity programs. Core operating income margin in constant currencies increased by 2.1 percentage points; currency had a negative impact of 1.1 percentage points,�resulting in a net increase of 1.0 percentage points to 33.1% of net sales.
Sandoz net sales increased 4% (+11% cc) to USD 2.5 billion in the fourth quarter, as volume growth of 20 percentage points more than compensated for 9 percentage points of price erosion. US sales of retail generics and biosimilars delivered strong growth (+24% cc), driven by recent successful launches, partly offset by higher price erosion. Germany grew (+5% cc) in a declining market, while Western Europe (excluding Germany) grew 4% (cc). Japan continued to show double-digit growth (+14% cc). In emerging markets, Asia (excluding Japan, +18% cc) and Latin America (+17% cc) grew strongly, while Central and Eastern Europe increased sales by 6% (cc) in the quarter. Sandoz strengthened its leading global position in biosimilars (USD 132 million, +18% cc), with double-digit sales growth driven by strong momentum in its three in-market products.
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1�The COPD portfolio includes Onbrez Breezhaler/Arcapta Neohaler, Seebri Breezhaler and Ultibro Breezhaler.
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Operating income increased 5% (+16% cc) to USD 290 million. Core operating income increased 12% (+21% cc) to USD 416 million. Core operating income margin in constant currencies increased 1.4 percentage points; currency had a negative impact of 0.3 percentage points, resulting in a net increase of 1.1 percentage points to 16.6% of net sales.
Discontinuing operations
For discontinuing operations, net sales grew 1% (+9% cc) to USD 1.6 billion in the fourth quarter. Operating loss was USD 1.2 billion, mainly driven by an exceptional pre-tax impairment charge of USD 1.1 billion related to the pending divestment to CSL of the influenza vaccines business. Core operating income was USD 93 million, and core operating income margin improved 5.8 percentage points to 6.0% of net sales. 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date. The cessation of depreciation and amortization related to discontinuing operations had a positive impact of USD 101 million on operating income and USD 49 million on core operating income in the fourth quarter, contributing 3.2 percentage points to the improvement in core operating income margin.
Vaccines1�net sales were USD 494 million (-2%, +4% cc) for the fourth quarter compared to USD 503 million in the prior-year period. Solid demand across the product portfolio was driven by the Meningitis franchise, which benefited from sales of Menveo, Menjugate and the recently launched Bexsero. This was offset by an earlier US influenza season and lower sales to the US Department of Health and Human Services.
Operating loss was USD 1.1 billion for the fourth quarter compared to a loss of USD 96 million in the prior-year period, driven by an exceptional pre-tax impairment charge of USD 1.1 billion for the influenza vaccines business. Due to the cessation of depreciation and amortization charges from the portfolio transformation announcement date, the prior year contained approximately USD 73�million of higher depreciation and amortization charges for the quarter compared to the current year, comprised of USD 35 million for depreciation and USD 38 million for amortization. Core operating loss for the fourth quarter was USD 6 million compared to a loss of USD 52 million for the prior-year period. The improvement in core operating loss was mainly due to a higher margin product mix and the cessation of depreciation of USD 35 million, partially offset by increased operating costs of the Holly Springs facility in the US and enrollment in two large Phase III quadrivalent influenza vaccine studies.
Comparing results for the fourth quarter of 2014 and the same period in 2013 including the blood transfusion diagnostics unit, Vaccines net sales declined 25% (-20% cc) and operating loss increased to USD 1.1 billion from USD 1 million in the year-ago period.
Consumer Health, which comprises OTC and Animal Health, saw net sales increase 3% (+11% cc) to USD 1.1 billion in the fourth quarter, with double-digit sales growth (+14% cc) in OTC and single-digit sales growth (+3% cc) in Animal Health. From a brand perspective, Voltaren in OTC and Denagard in Animal Health were key growth drivers, up 20% (cc) and 11% (cc), respectively.
Operating income amounted to USD 172 million compared to USD 48 million in the prior-year quarter, driven by higher gross margin from sales, strong operating leverage and income from a divestment in the US. The cessation of depreciation and amortization charges from the portfolio transformation announcement date had a positive impact of USD 28 million for the quarter, comprised of USD 13 million for depreciation and USD 15 million for amortization. Core operating income increased 92% (+122% cc) to USD 115 million. Core operating income margin in constant currencies increased by 5.9 percentage points; currency had a negative impact of 0.9 percentage points, resulting in a net increase of 5.0 percentage points to 10.8% of net sales.
1�All periods exclude certain intellectual property rights and related other revenues which will be retained by Novartis and are now reported under Corporate activities, with 2013 reported results being restated for this impact. All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit.
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Full year
Strong net sales performance more than offset impact of generic competition
Group net sales increased 1% (+3% cc) to USD 58.0 billion in the full year. Growth Products contributed USD 18.6 billion or 32% of Group net sales, up 18% (USD) over 2013. Loss of exclusivity, including for Diovan, impacted sales by approximately USD 2.4 billion.
Group operating income increased 1% (+7% cc) to USD 10.7 billion. The USD 0.9 billion exceptional gain in the first quarter from the divestment of the blood transfusion diagnostics unit to Grifols S.A. was more than offset by an exceptional pre-tax impairment charge of USD 1.1 billion in the fourth quarter related to the pending divestment to CSL of the influenza vaccines business. The negative currency impact of 6 percentage points was mainly due to the weakening of emerging market currencies (especially the ruble) and the yen against the US dollar. Operating income margin was 18.5% of net sales, up 0.8 percentage points (cc) from the prior-year period. Currency had a negative impact of 0.9 percentage points, resulting in a net decrease of 0.1 percentage points. The cessation of depreciation and amortization charges related to the discontinuing operations had a positive impact of USD 277 million for the full year, improving operating income margin by 0.5 percentage points (cc). The adjustments made to Group operating income to arrive at core operating income amounted to USD 3.9 billion (2013: USD 3.5 billion).
Core operating income increased 3% (+8% cc) to USD 14.6 billion. Core operating income margin in constant currencies increased 1.2 percentage points; currency had a negative currency impact of 0.7 percentage points, resulting in a net increase of 0.5 percentage points to 25.2% of net sales. The cessation of depreciation and amortization charges related to the discontinuing operations had a positive impact of USD 134 million, improving the core operating income margin by 0.2 percentage points (cc).
Group net income of USD 10.3 billion was up 12% (+19% cc), growing ahead of operating income mainly due to higher income from associated companies, which included a pre-tax gain of USD 0.8 billion from the sale of the shares of Idenix Pharmaceuticals, Inc. to Merck & Co., and a pre-tax gain of USD 0.4 billion from the divestment of the shareholding in LTS Lohmann Therapie-Systeme AG, partly offset by an increase in tax expense.
EPS was up 14% (+20% cc) to USD 4.21, growing ahead of net income due to lower average outstanding shares and lower minority interest.
Group core net income of USD 12.8 billion was up 3% (+8% cc), in line with core operating income.
Core EPS was USD 5.23 (+4%, +10% cc), growing ahead of core net income due to lower average outstanding shares and lower minority interest.
Free cash flow for the year was USD 10.8 billion, an increase of 12% or USD 1.2 billion compared to prior year. This was primarily due to higher cash flows from operating activities, which mainly benefited from higher operating income adjusted for non-cash items, despite negative currency effects and increased hedging gains, partially offset by higher investments in intangible assets.
Comparing results for the full year of 2014 and the same period in 2013 including the blood transfusion diagnostics unit, Group total net sales remained stable in USD (0%, +2% cc), Group total operating income was down 2% (+5% cc), Group total net income increased 11% (+17% cc) and Group total EPS grew slightly ahead of net income at 12% (+18% cc) due to lower average outstanding shares and lower minority interest.
Continuing operations
For continuing operations, net sales grew 1% (+3% cc) to USD 52.2 billion in the full year. Operating income was up 1% (+7% cc), core operating income increased 2% (+7% cc) and core operating income margin improved 0.3 percentage points to 27.7% of net sales. Continuing operations do not yet include the results from oncology net assets to be acquired from GSK on closing of the transaction or the results from the 36.5% interest in the GSK/Novartis consumer healthcare joint venture that will be created at the same time.
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Pharmaceuticals delivered net sales of USD 31.8 billion (-1%, +1% cc) for the full year, driven by volume growth (+7 percentage points) and pricing (+1 percentage points), offset by the impact of generic competition (-7 percentage points). Growth Products continued to drive performance and rejuvenate the portfolio, generating USD 13.7 billion of division net sales, up 17% (cc) over the previous year.
Operating income was USD 8.5 billion (-10%, -5% cc) for the full year, mainly impacted by higher restructuring charges and higher impairments. Core operating income was USD 9.5 billion (0%, +4% cc), generating core operating leverage due to productivity programs and effective resource allocation. Core margin in constant currencies improved by 1.1 percentage points; currency had a negative impact of 0.8 percentage points, resulting in a net margin expansion of 0.3 percentage points to 29.9% of net sales.
Alcon net sales grew 3% (+6% cc) to USD 10.8 billion for the full year 2014. Surgical franchise sales advanced 5% (+7% cc), driven by strong sales of equipment, led by the launch of the Centurion phacoemulsification cataract platform and Verion image-guided pre-operative diagnostic system, continued growth of the LenSx femtosecond laser platform, and growth in cataract and vitreoretinal disposables. Growth in Ophthalmic Pharmaceuticals (+3%, +5% cc) was driven by double-digit growth of Systane, Ilevro, and fixed-dose glaucoma combination products, offset by weak allergy and otic seasons in the US and Japan. Vision Care (+2%, +4% cc) benefited from launches of innovative contact lenses, including Dailies Total1 and AirOptix Colors, partially offset by declining contact lens care sales.
Operating income increased 30% (+43% cc) to USD 1.6 billion, driven by strong operating performance as well as the ending in 2013 of integration charges related to the acquisition of Alcon. Core operating income was USD 3.8 billion (+3%, +8% cc). Core operating income margin in constant currencies increased by 0.6 percentage points; currency had a negative impact of 0.6 percentage points,�resulting in a stable core margin of 35.2% of net sales.
Sandoz�net sales increased by 4% (+7% cc) to USD 9.6 billion, as volume growth of 15 percentage points more than offset 8 percentage points of price erosion. Performance was driven by strong retail generics and biosimilars sales growth (including the Diovan monotherapy authorized generic launch) in Asia (excluding Japan) (+15% cc), the US (+14% cc), Latin America (+10% cc) and Canada (+9% cc). Central and Eastern Europe (+5% cc) and Western Europe (excluding Germany) (+4% cc) showed solid growth, while German sales were stable (0% cc). Biosimilars grew 23% (cc) to reach USD 514 million globally in 2014.
Sandoz operating income increased by 6% (+14% cc) to USD 1.1 billion, benefiting from strong operating performance and unrepeated prior-year legal settlements. Core operating income was USD 1.6 billion (+2%, +7% cc). Core operating income margin in constant currencies increased by 0.1 percentage points, despite high price erosion; currency had a negative impact of 0.5 percentage points, resulting in a net decrease of 0.4 percentage points to 16.4% of net sales.
Discontinuing operations
For discontinuing operations, net sales grew 6% (+9% cc) to USD 5.8 billion in the full year. Operating loss was USD 353 million (including the USD 1.1 billion exceptional pre-tax impairment charge related to the pending divestment to CSL of the influenza vaccines business), core operating income was USD 143 million, and core operating income margin improved 2.8 percentage points to 2.5% of net sales. 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date. The cessation of depreciation and amortization related to discontinuing operations had a positive impact of USD 277 million on operating income and USD 134 million on core operating income in the full year, which contributed to the improvement in core operating income margin.
Vaccines1�net sales increased 8% (+10% cc) to USD 1.5 billion for the year compared to USD 1.4 billion in 2013, driven by solid demand across the product portfolio, particularly in the Meningitis franchise with the recently launched Bexsero.
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1�All periods exclude certain intellectual property rights and related other revenues which will be retained by Novartis and are now reported under Corporate activities, with 2013 reported results being restated for this impact. All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit.
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Operating loss was USD 552 million for 2014 compared to a loss of USD 477 million in 2013. The increase in operating loss was driven by the impairment of the influenza vaccines business of USD 1.1 billion, mostly offset by the USD 876 million exceptional gain from the divestment of the blood transfusion diagnostics unit to Grifols S.A. Due to the cessation of depreciation and amortization charges from the portfolio transformation announcement date, the prior year contained approximately USD 204 million of higher depreciation and amortization charges compared to the current year, comprised of USD 95 million for depreciation and USD 109 million for amortization. Core operating loss was USD 290 million in 2014 compared to a loss of USD 302 million in the prior year. The improvement in core operating loss was driven by increased sales and the cessation of depreciation of USD 95 million, partially offset by operating costs of the Holly Springs facility and enrollment in two large Phase III quadrivalent influenza vaccine studies.
Comparing results for 2014 and 2013 including the blood transfusion diagnostics unit, Vaccines net sales declined 23% (-21% cc) and operating loss for 2014 amounted to USD 552 million compared to a loss of USD 238 million in 2013.
Consumer Health net sales increased 5% (+8% cc) to USD 4.3 billion in 2014, driven by strong performance of key global brands and product re-launches in OTC (+9% cc) and Animal Health (+5% cc).
Operating income amounted to USD 470 million compared to USD 178 million in the prior-year period, driven by higher gross margin from incremental sales and lower Lincoln plant remediation and restructuring expenses. The cessation of depreciation and amortization charges from the portfolio transformation announcement date had a positive impact of USD 73 million in the year, comprised of USD 34 million for depreciation and USD 39 million for amortization. Core operating income increased 52% (+72% cc) to USD 452 million. Core operating income margin in constant currencies increased by 4.3 percentage points; currency had a negative impact of 1.0 percentage point, resulting in a net increase of 3.3 percentage points to 10.6% of net sales.
Executing on innovation, growth and productivity
A consistent focus on three core priorities innovation, growth and productivity guides every aspect of our long-term strategy. In the fourth quarter, we made significant progress in each of these areas.
Innovation: Strong pipeline progress continues
The fourth quarter saw continued pipeline progress with positive regulatory decisions and significant clinical trial data released. Key developments are included below.
New approvals and positive opinions
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Cosentyx approved in the US, EU and Japan
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In January 2015, Cosentyx (secukinumab, formerly known as AIN457) received regulatory approval in the US and EU for psoriasis, following the December approval in Japan in psoriasis vulgaris and psoriatic arthritis.
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FDA and EC approved Signifor long-acting release formulation for acromegaly
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Signifor (pasireotide), a next-generation somatostatin analog, was approved in the US and EU as a long acting release formulation for the treatment of patients with acromegaly.
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Travatan approved for additional indication in the EU
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The EC approved a new indication for Travatan eye drops solution (40�g/mL travoprost) in pediatric patients with ocular hypertension or pediatric glaucoma.
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FDA Advisory Committee recommended approval for biosimilar filgrastim
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In January 2015, the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of Sandoz investigational biosimilar filgrastim in the US for use in all indications included in the reference product's (Neupogen�) label.
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FDA granted accelerated approval for Bexsero
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In January 2015, FDA granted an accelerated approval of Bexsero (Meningococcal Group B Vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age.
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Regulatory submissions and filings
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LCZ696 filed in US and EU for heart failure
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Regulatory applications have been submitted in both the US and EU for LCZ696 as a treatment for patients with heart failure with reduced ejection fraction (HFrEF). In the EU, CHMP granted accelerated assessment to LCZ696, shortening the review process by 60 days.
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Regulatory applications submitted to FDA for QVA149 and NVA237
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In December 2014, Novartis completed regulatory submissions to the FDA for QVA149 and NVA237 for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Submissions included pivotal Phase III results from the EXPEDITION and GEM clinical trial programs, which met both primary and secondary endpoints.
Results from important clinical trials and other highlights
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Head-to-head psoriasis study demonstrated Cosentyx superiority to Stelara�
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Building on the positive data previously reported in psoriasis, a Phase IIIb study demonstrated Cosentyx (secukinumab) superiority to Stelara� (ustekinumab) in clearing skin, and met both primary and secondary endpoints.
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New LCZ696 analyses reinforced strong competitive profile in heart failure
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New analyses showed LCZ696 could change the course of heart failure for patients, with lower incidence of sudden deaths, emergency room visits, hospitalizations, worsening symptoms and need for more intense treatment versus enalapril in HFrEF patients.
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CTL019 data showed complete remissions in 92% of pediatric r/r ALL patients
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Findings from continued clinical studies of CTL019 showed 92% of children and young adults (36 out of 39) with relapsed/refractory acute lymphoblastic leukemia (r/r ALL) experienced complete remissions. Novartis and the University of Pennsylvania have an exclusive global collaboration to research, develop and commercialize CAR T cell therapies for the investigational treatment of cancers.
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New data�reinforced Jakavi safety and efficacy profile in myelofibrosis
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An ongoing analysis of 1,144 myelofibrosis patients treated with Jakavi (ruxolitinib) reinforced the established safety profile and showed 69% of patients achieved more than 50% reduction in spleen size from baseline. Patients also experienced a clinically meaningful improvement in myelofibrosis symptom score.
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Six-year data reinforced superiority of Tasigna over Glivec in Ph+ CML
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A six-year update from the randomized Phase III ENESTnd study continued to show the superiority of Tasigna (nilotinib) compared to Glivec (imatinib) at achieving higher rates of early, deep and sustained molecular responses in newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) patients.
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Alcon initiated Phase III trial of RTH258 in wet AMD
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In December 2014, Alcon initiated a Phase III program to evaluate the efficacy and safety of RTH258 (formerly known as ESBA1008) versus aflibercept in patients with wet age-related macular degeneration (AMD). This program follows positive Phase II study results comparing the safety and efficacy of RTH258 to ranibizumab and aflibercept, respectively.
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Results of trial evaluating Afinitor in HER2+ advanced breast cancer
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The Phase III BOLERO-1 trial evaluating Afinitor (everolimus) in women with HER2+ advanced breast cancer did not meet its primary objective for progression-free survival (PFS).
Non-statistically significant PFS benefit was reported in the pre-defined HER2+, HR- subgroup supporting continued research of the PI3K/AKT/mTOR pathway.
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Novartis shared update on fingolimod Phase III trial in PPMS
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The Phase III INFORMS study in primary progressive multiple sclerosis (PPMS) did not show a significant difference between fingolimod and placebo on a combination of disability measures. The safety results were consistent with the well-characterized safety profile of fingolimod in relapsing MS.
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Growth: Strong commercial execution and global presence continued to drive growth
In the fourth quarter, key growth drivers including Growth Products such as�Gilenya, Tasigna, Afinitor and Jakavi, as well as biosimilars and Emerging Growth Markets continued to demonstrate the strength of our portfolio across disease areas and geographies.
Key Growth Products
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Growth Products contributed 32% of Group net sales in the fourth quarter, and were up 14% (USD) over the 2013 period. In Pharmaceuticals, Growth Products contributed 46% of division net sales in the quarter, and were up 19% (cc) over the previous-year quarter.
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Gilenya (USD�666 million, +32% cc), our oral MS therapy, continued to achieve double-digit growth in the quarter as prescribers move towards oral treatments with higher efficacy and away from more traditional injectable therapies.
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Tasigna (USD 428 million, +30% cc) continued to grow strongly in the US and other markets, driving growth in our CML franchise (which includes Gleevec/Glivec in addition to Tasigna).
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Afinitor (USD 426 million, +24% cc) performed strongly, driven by strong growth in the US, Japan and other markets around the world.
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Xolair (USD 200 million, +25% cc) continued to see strong growth, benefiting from indications in certain forms of allergic asthma, as well as chronic spontaneous urticaria (CSU)/chronic idiopathic urticaria (CIU).
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Jakavi (USD 84 million, +91% cc), an oral JAK inhibitor approved in myelofibrosis, grew strongly over the previous-year quarter.
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Biosimilars (USD 132 million, +18% cc) continued to grow at a strong double-digit rate in the quarter, reinforcing Sandoz global leadership position.
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Emerging Growth Markets
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Net sales in our Emerging Growth Markets which comprise all markets except the US, Canada, Western Europe, Japan, Australia and New Zealand grew 12% (cc) in the fourth quarter (excluding the blood transfusion diagnostics unit). Growth was led by Brazil (+20% cc) and Russia (+21% cc, but down 16% in USD).
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Productivity: Continued focus on efficiency to improve margins
Ongoing productivity initiatives relate to procurement and resource allocation across the portfolio, as well as R&D, our manufacturing network and supporting infrastructure. Improving productivity and leveraging synergies across divisions will help us support margins.
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Novartis Business Services (NBS) was launched in July and at the end of fourth quarter had over 7,500 associates. Organizational structure is established and the financial systems are in place as of January 2015 making NBS fully operational as a shared services organization. NBS is designed to enhance profitability by harmonizing high-quality services at better price across the Group and Divisions. Synergies generated by the organization are expected to improve margin over time.
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In the fourth quarter, we generated approximately USD 500 million in Procurement savings by leveraging our scale.
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In addition, we continued to optimize our manufacturing footprint. Related to this initiative, we recorded exceptional charges of USD 34 million in the fourth quarter and USD 183 million in the full year. This brings total exceptional charges to USD 698 million cumulatively since the program began in the fourth quarter of 2010.
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Our productivity initiatives generated gross savings that contributed approximately USD 881 million in the fourth quarter. We achieved productivity savings of approximately USD 2.9 billion or 5% of net sales in 2014.
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Quality: Continued focus on quality remediation
Novartis continues to reinforce the culture of quality at all levels of the organization. There were a total of 39 global health authority inspections during the fourth quarter (247 in the full year, of which 210 were at manufacturing sites), 6 of which were conducted by the FDA (38 in the full year). All FDA inspections in the fourth quarter were assessed as good or satisfactory. The outcome of two FDA inspections of manufacturing sites, which were conducted in the third quarter, are still pending. Two inspections in 2014 were assessed as unsatisfactory.
In addition, the FDA lifted a Warning Letter highlighting compliance issues at three Sandoz manufacturing sites at Boucherville in Canada and Broomfield and Wilson in the US last July. A Warning Letter relating to production of the Alcon LenSx laser surgery system was also lifted in May 2014. The Unterach inspection was closed in December 2014 with zero observations, and the observations outlined in a May 2013 Warning Letter issued to Unterach were determined to be corrected and verified. These outcomes validate the intense approach and emphasis on driving sustainable solutions.
Capital structure and net debt
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Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns will remain a priority in the future. Strong cash flows and a sound capital structure have allowed Novartis to focus on driving innovation, growth and productivity across its diversified healthcare portfolio, while keeping its double-A credit rating as a reflection of financial strength and discipline.
During 2014, 51.7 million treasury shares were delivered as a result of options exercised and physical share deliveries related to employee participation programs. 52.2 million shares were repurchased on the SIX Swiss Exchange first trading line and from employees (shares previously granted under the respective programs). In addition, Novartis repurchased 27.0 million shares on the second trading line in 2014 under the announced share buy-back of USD 5.0 billion spread over two years. With these transactions, the total number of shares outstanding was reduced by 27.5 million in 2014.
Also during 2014, Novartis issued four bonds (two bonds in USD and two bonds in EUR) for a total amount of USD 5.5 billion and repaid a USD 2.0 billion bond issued in February 2009 at maturity.
As of December 31, 2014, the net debt stood at USD 6.5 billion compared to USD 8.8 billion at December 31, 2013. The decrease of USD 2.3 billion was driven by the free cash flow of USD 10.8 billion, the proceeds from options exercised of USD 2.4 billion, net divestment proceeds of USD 2.1 billion and other net cash inflow items of USD 0.7 billion, partially compensated by the cash outflows for the dividend payment of USD 6.8 billion and share repurchases of USD 6.9 billion.
The long-term credit rating for the company continues to be double-A (Moodys Aa3; Standard & Poors AA-; Fitch AA).
On July 16, 2014, Novartis announced the divestment of its 43% stake in LTS Lohmann Therapie-Systeme AG. The transaction closed in the fourth quarter and Novartis realized a pre-tax gain of approximately USD 0.4 billion. In addition, on August 5, 2014, Merck & Co. announced that it had acquired Idenix Pharmaceuticals, Inc. As a result, the 22% stake held by Novartis was divested, resulting in a pre-tax gain of approximately USD 0.8 billion. Both of these items were recorded in income from associated companies.
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Portfolio transformation update
On January 1, 2015, Novartis announced that it completed the divestment of its Animal Health Division to Lilly for approximately USD 5.4 billion. This divestment is part of a set of transactions announced last April to focus Novartis on three leading businesses with innovation power and global scale: innovative pharmaceuticals, eye care and generics.
As a result of the Animal Health divestment, Novartis will show an exceptional pre-tax gain of approximately USD 4.6 billion in the first quarter of 2015. Apart from this divestment gain, 2015 Consumer Health results will only include the Novartis OTC Division.
Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with CSL to be completed in the second half of 2015, subject to customary closing conditions including regulatory approvals.
2015 Group outlook for continuing operations
Barring unforeseen events
This outlook is for continuing operations based on a modeling assumption that the GSK transactions will close on March 31, 2015.1
Group net sales in 2015 are expected to grow mid-single digit (cc), after absorbing the impact of generic competition, which is expected to be as much as USD 2.5 billion compared to USD 2.4 billion in 2014. Group core operating income is expected to grow ahead of sales at a high-single digit rate (cc) in 2015. All these comparisons are versus 2014 continuing operations.
From a divisional perspective, we expect net sales performance (cc) in 2015 to be as follows:
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Pharmaceuticals: mid-single digit growth
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Alcon: mid to high-single digit growth
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Sandoz: mid-single digit growth
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If mid-January exchange rates prevail for the remainder of 2015, the currency impact for the full year vs. 2014 would be -7 percentage points on net sales and -12 percentage points on core operating income from continuing operations. This currency impact results from the significant strengthening of the US dollar against most currencies, especially during the fourth quarter of 2014. Compared to our expectations at the beginning of 2015, the mid-January appreciation of the Swiss franc has worsened the expected currency impact on core operating income by 4 percentage points (included in the -12 percentage points) as Switzerland represents about 13% of our operating expenses. This appreciation has a minor impact on net sales, since Novartis only generates about 2% of its net sales in Swiss francs.
With respect to core operating income margin as a percentage of sales, we expect an improvement between reported total Group 2014 core margin and 2015 continuing operations core margin despite the currency impact. This is driven by the portfolio transformation transactions, which will focus Novartis on our 3 leading divisions, and by the expected operational core margin expansion in the continuing business due to core operating income growing faster (high-single digit in cc) than sales (mid-single digits growth in cc).
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1�Forecast assumption for modeling purposes only. Novartis continues to expect the GSK transactions to be completed in the first half of 2015. Continuing operations will include the results from oncology assets to be acquired from GSK and the results from the 36.5% interest in the GSK/Novartis consumer healthcare OTC joint venture interest (latter, reported as income from associated companies) from the date of closing
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Annual General Meeting
Dividend proposal
The Board proposes a dividend payment of CHF 2.60 per share for 2014, up 6% from CHF 2.45 per share in 2013, representing the 18th consecutive dividend increase since the creation of Novartis in December 1996. Shareholders will vote on this proposal at the 2015 Annual General Meeting (AGM) scheduled for February 27, 2015.
Reduction of Share Capital
The Board proposes to cancel 29,200,000 shares repurchased on the second trading line under the sixth share repurchase program in the financial years 2013 and 2014 and to reduce the share capital accordingly by CHF 14,600,000, from CHF 1,353,096,500 to CHF 1,338,496,500.
Revision of the Articles of Incorporation
The Board proposes to amend the Articles of Incorporation of Novartis AG to fulfill the requirements of both the Swiss Federal Ordinance Against Excessive Compensation in Public Corporations (OAEC) and current best corporate governance and compensation practices. For more information on the proposed amendments, please refer to the brochure Report of the Board of Directors on the Revision of the Articles of Incorporation (published on our website www.novartis.com).
Votes on Compensation for the Members of the Board and the Executive Committee
The Board proposes that shareholders approve in two separate binding votes the total maximum amount of compensation for the members of the Board covering the period from the 2015 AGM to the 2016 AGM and the total maximum amount of compensation in respect of 2016 for the members of the Executive Committee. Furthermore, the Board proposes that shareholders endorse in an advisory vote the 2014 Compensation Report.
Re-elections of the Chairman and the Members of the Board, Election to the Board
The Board proposes the re-election of Joerg�Reinhardt, Ph.D. (also as Chairman of the Board), Dimitri Azar, M.D., Verena A. Briner, M.D., Srikant Datar, Ph.D., Ann Fudge, Pierre Landolt, Ph.D., Andreas von Planta, Ph.D., Charles L. Sawyers, M.D., Enrico Vanni, Ph.D., and William T. Winters as well as the election of Nancy C. Andrews, M.D., Ph.D., as members of the Board, each until the end of the next Annual General Meeting.
Re-elections and Election to the Compensation Committee
The Board proposes the re-election of Srikant Datar, Ph.D., Ann Fudge, and Enrico Vanni, Ph.D., and the election of William T. Winters as members of the Compensation Committee, each until the end of the next Annual General Meeting.
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Summary Financial Performance
Group total
| � | � | � | � | � | � |
excl. Diagnostics1
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Reported
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excl. Diagnostics1
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Reported
|
� | ||||||||||||||||||||||
| � | � | � | � | Q4 2014 | 2 | � | � | Q4 2013 | � | � |
% change
|
� | � | � | Q4 2013 | � | � |
FY 20142
|
� | � |
FY 2013
|
� | � |
% change
|
� | � |
FY 2013
|
� | |||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
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USD m
|
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USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | ||||||||||
|
Net sales
|
� | � | � | 14 633 | � | � | � | 14 926 | � | � | � | -2 | � | � | � | 4 | � | � | � | 15 078 | � | � | � | 57 996 | � | � | � | 57 355 | � | � | � | 1 | � | � | � | 3 | � | � | � | 57 920 | � |
|
Operating income
|
� | � | � | 1 172 | � | � | � | 2 278 | � | � | � | -49 | � | � | � | -39 | � | � | � | 2 373 | � | � | � | 10 736 | � | � | � | 10 671 | � | � | � | 1 | � | � | � | 7 | � | � | � | 10 910 | � |
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��As % of net sales
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� | � | � | 8.0 | � | � | � | 15.3 | � | � | � | � | � | � | � | � | � | � | � | 15.7 | � | � | � | 18.5 | � | � | � | 18.6 | � | � | � | � | � | � | � | � | � | � | � | 18.8 | � |
|
Core operating income
|
� | � | � | 3 322 | � | � | � | 3 293 | � | � | � | 1 | � | � | � | 9 | � | � | � | � | � | � | � | 14 616 | � | � | � | 14 191 | � | � | � | 3 | � | � | � | 8 | � | � | � | � | � |
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��As % of net sales
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� | � | � | 22.7 | � | � | � | 22.1 | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | 25.2 | � | � | � | 24.7 | � | � | � | � | � | � | � | � | � | � | � | � | � |
Continuing operations
Continuing operations do not yet include the results from oncology net assets to be acquired from GSK on closing of the transaction or the results from the 36.5% interest in the GSK/Novartis consumer healthcare joint venture that will be created at the same time. See page 22 of the Condensed Financial Report (CFR) for full explanation.
Continuing operations
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
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� | � |
FY 2014
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� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
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USD
|
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cc
|
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USD m
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USD m
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� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Net sales
|
� | � | � | 13 075 | � | � | � | 13 389 | � | � | � | -2 | � | � | � | 3 | � | � | � | 52 180 | � | � | � | 51 869 | � | � | � | 1 | � | � | � | 3 | � |
|
Operating income
|
� | � | � | 2 351 | � | � | � | 2 333 | � | � | � | 1 | � | � | � | 10 | � | � | � | 11 089 | � | � | � | 10 983 | � | � | � | 1 | � | � | � | 7 | � |
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��As % of net sales
|
� | � | � | 18.0 | � | � | � | 17.4 | � | � | � | � | � | � | � | � | � | � | � | 21.3 | � | � | � | 21.2 | � | � | � | � | � | � | � | � | � |
|
Core operating income
|
� | � | � | 3 229 | � | � | � | 3 290 | � | � | � | -2 | � | � | � | 6 | � | � | � | 14 473 | � | � | � | 14 207 | � | � | � | 2 | � | � | � | 7 | � |
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��As % of net sales
|
� | � | � | 24.7 | � | � | � | 24.6 | � | � | � | � | � | � | � | � | � | � | � | 27.7 | � | � | � | 27.4 | � | � | � | � | � | � | � | � | � |
Pharmaceuticals
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
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� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
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USD m
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USD
|
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cc
|
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|
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USD m
|
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USD
|
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cc
|
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|
Net sales
|
� | � | � | 7 860 | � | � | � | 8 323 | � | � | � | -6 | � | � | � | 0 | � | � | � | 31 791 | � | � | � | 32 214 | � | � | � | -1 | � | � | � | 1 | � |
|
Operating income
|
� | � | � | 1 611 | � | � | � | 2 013 | � | � | � | -20 | � | � | � | -14 | � | � | � | 8 471 | � | � | � | 9 376 | � | � | � | -10 | � | � | � | -5 | � |
|
��As % of net sales
|
� | � | � | 20.5 | � | � | � | 24.2 | � | � | � | � | � | � | � | � | � | � | � | 26.6 | � | � | � | 29.1 | � | � | � | � | � | � | � | � | � |
|
Core operating income
|
� | � | � | 1 977 | � | � | � | 2 133 | � | � | � | -7 | � | � | � | 0 | � | � | � | 9 514 | � | � | � | 9 523 | � | � | � | 0 | � | � | � | 4 | � |
|
��As % of net sales
|
� | � | � | 25.2 | � | � | � | 25.6 | � | � | � | � | � | � | � | � | � | � | � | 29.9 | � | � | � | 29.6 | � | � | � | � | � | � | � | � | � |
Alcon
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Net sales
|
� | � | � | 2 703 | � | � | � | 2 655 | � | � | � | 2 | � | � | � | 7 | � | � | � | 10 827 | � | � | � | 10 496 | � | � | � | 3 | � | � | � | 6 | � |
|
Operating income
|
� | � | � | 365 | � | � | � | 172 | � | � | � | 112 | � | � | � | 155 | � | � | � | 1 597 | � | � | � | 1 232 | � | � | � | 30 | � | � | � | 43 | � |
|
��As % of net sales
|
� | � | � | 13.5 | � | � | � | 6.5 | � | � | � | � | � | � | � | � | � | � | � | 14.8 | � | � | � | 11.7 | � | � | � | � | � | � | � | � | � |
|
Core operating income
|
� | � | � | 895 | � | � | � | 851 | � | � | � | 5 | � | � | � | 14 | � | � | � | 3 811 | � | � | � | 3 694 | � | � | � | 3 | � | � | � | 8 | � |
|
��As % of net sales
|
� | � | � | 33.1 | � | � | � | 32.1 | � | � | � | � | � | � | � | � | � | � | � | 35.2 | � | � | � | 35.2 | � | � | � | � | � | � | � | � | � |
Sandoz
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Net sales
|
� | � | � | 2 512 | � | � | � | 2 411 | � | � | � | 4 | � | � | � | 11 | � | � | � | 9 562 | � | � | � | 9 159 | � | � | � | 4 | � | � | � | 7 | � |
|
Operating income
|
� | � | � | 290 | � | � | � | 276 | � | � | � | 5 | � | � | � | 16 | � | � | � | 1 088 | � | � | � | 1 028 | � | � | � | 6 | � | � | � | 14 | � |
|
��As % of net sales
|
� | � | � | 11.5 | � | � | � | 11.4 | � | � | � | � | � | � | � | � | � | � | � | 11.4 | � | � | � | 11.2 | � | � | � | � | � | � | � | � | � |
|
Core operating income
|
� | � | � | 416 | � | � | � | 373 | � | � | � | 12 | � | � | � | 21 | � | � | � | 1 571 | � | � | � | 1 541 | � | � | � | 2 | � | � | � | 7 | � |
|
��As % of net sales
|
� | � | � | 16.6 | � | � | � | 15.5 | � | � | � | � | � | � | � | � | � | � | � | 16.4 | � | � | � | 16.8 | � | � | � | � | � | � | � | � | � |
Corporate
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Operating income/loss
|
� | � | � | 85 | � | � | � | -128 | � | � |
nm
|
� | � |
nm
|
� | � | � | -67 | � | � | � | -653 | � | � | � | 90 | � | � | � | 91 | � | ||
|
Core operating loss
|
� | � | � | -59 | � | � | � | -67 | � | � | � | 12 | � | � | � | -3 | � | � | � | -423 | � | � | � | -551 | � | � | � | 23 | � | � | � | 27 | � |
nm = not meaningful
�
�
1�All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 85 of the CFR.
2�2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date. See page 22 of the CFR.
�
13
�
�
�
�
Discontinuing operations
Despite the required presentation of discontinuing operations, until the GSK and CSL transactions are closed, Novartis remains fully committed to all Group activities. 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date. See page 22 of the Condensed Financial Report (CFR) for full explanation.
Discontinuing operations1
| � | � | � | � | � | � |
excl. Diagnostics2
|
� | � |
Reported
|
� | � | � | � | � |
excl. Diagnostics2
|
� | � |
Reported
|
� | ||||||||||||||||||||||
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � | � | Q4 2013 | � | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | � |
FY 2013
|
� | |||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | ||||||||||
|
Net sales
|
� | � | � | 1 558 | � | � | � | 1 537 | � | � | � | 1 | � | � | � | 9 | � | � | � | 1 689 | � | � | � | 5 816 | � | � | � | 5 486 | � | � | � | 6 | � | � | � | 9 | � | � | � | 6 051 | � |
|
Operating loss
|
� | � | � | -1 179 | � | � | � | -55 | � | � |
nm
|
� | � |
nm
|
� | � | � | 40 | � | � | � | -353 | � | � | � | - 312 | � | � | � | -13 | � | � | � | -5 | � | � | � | - 73 | � | ||
|
��As % of net sales
|
� | � | � | -75.7 | � | � | � | -3.6 | � | � | � | � | � | � | � | � | � | � | � | 2.4 | � | � | � | -6.1 | � | � | � | -5.7 | � | � | � | � | � | � | � | � | � | � | � | -1.2 | � |
|
Core operating income/loss
|
� | � | � | 93 | � | � | � | 3 | � | � |
nm
|
� | � |
nm
|
� | � | � | � | � | � | � | 143 | � | � | � | - 16 | � | � |
nm
|
� | � |
nm
|
� | � | � | � | � | ||||
|
��As % of net sales
|
� | � | � | 6.0 | � | � | � | 0.2 | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | 2.5 | � | � | � | -0.3 | � | � | � | � | � | � | � | � | � | � | � | � | � |
nm = not meaningful
Vaccines3,4
| � | � | � | � | � | � |
excl. Diagnostics2
|
� | � |
Reported
|
� | � | � | � | � |
excl. Diagnostics2
|
� | � |
Reported
|
� | ||||||||||||||||||||||
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � | � | Q4 2013 | � | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | � |
FY 2013
|
� | |||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | ||||||||||
|
Net sales
|
� | � | � | 494 | � | � | � | 503 | � | � | � | -2 | � | � | � | 4 | � | � | � | 655 | � | � | � | 1 537 | � | � | � | 1 422 | � | � | � | 8 | � | � | � | 10 | � | � | � | 1 987 | � |
|
Operating loss
|
� | � | � | -1 084 | � | � | � | -96 | � | � |
nm
|
� | � |
nm
|
� | � | � | -1 | � | � | � | -552 | � | � | � | -477 | � | � | � | -16 | � | � | � | -15 | � | � | � | -238 | � | ||
|
��As % of net sales
|
� | � | � | -219.4 | � | � | � | -19.1 | � | � | � | � | � | � | � | � | � | � | � | -0.2 | � | � | � | -35.9 | � | � | � | -33.5 | � | � | � | � | � | � | � | � | � | � | � | -12.0 | � |
|
Core operating loss
|
� | � | � | -6 | � | � | � | -52 | � | � |
nm
|
� | � |
nm
|
� | � | � | � | � | � | � | -290 | � | � | � | -302 | � | � | � | 4 | � | � | � | 5 | � | � | � | � | � | ||
|
��As % of net sales
|
� | � | � | -1.2 | � | � | � | -10.3 | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | -18.9 | � | � | � | -21.2 | � | � | � | � | � | � | � | � | � | � | � | � | � |
nm = not meaningful
Consumer Health5
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Net sales
|
� | � | � | 1 064 | � | � | � | 1 034 | � | � | � | 3 | � | � | � | 11 | � | � | � | 4 279 | � | � | � | 4 064 | � | � | � | 5 | � | � | � | 8 | � |
|
Operating income
|
� | � | � | 172 | � | � | � | 48 | � | � | � | 258 | � | � | � | 292 | � | � | � | 470 | � | � | � | 178 | � | � | � | 164 | � | � | � | 196 | � |
|
��As % of net sales
|
� | � | � | 16.2 | � | � | � | 4.6 | � | � | � | � | � | � | � | � | � | � | � | 11.0 | � | � | � | 4.4 | � | � | � | � | � | � | � | � | � |
|
Core operating income
|
� | � | � | 115 | � | � | � | 60 | � | � | � | 92 | � | � | � | 122 | � | � | � | 452 | � | � | � | 298 | � | � | � | 52 | � | � | � | 72 | � |
|
��As % of net sales
|
� | � | � | 10.8 | � | � | � | 5.8 | � | � | � | � | � | � | � | � | � | � | � | 10.6 | � | � | � | 7.3 | � | � | � | � | � | � | � | � | � |
Corporate
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Operating loss
|
� | � | � | -267 | � | � | � | -7 | � | � |
nm
|
� | � |
nm
|
� | � | � | -271 | � | � | � | -13 | � | � |
nm
|
� | � |
nm
|
� | ||||
|
Core operating loss
|
� | � | � | -16 | � | � | � | -5 | � | � | � | -220 | � | � | � | -220 | � | � | � | -19 | � | � | � | -12 | � | � | � | -58 | � | � | � | -65 | � |
nm = not meaningful
�
1�The cessation of depreciation and amortization had a positive impact of USD 101 million on operating income and USD 49 million on core operating income in the fourth quarter, and an impact of USD 277 million and USD 134 million on operating income and core operating income respectively in the full year.
2�All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 85 of the CFR.
3�The prior year contained higher depreciation and amortization charges of USD 73 million in operating income and USD 35 million in core operating income in the fourth quarter compared to the current year, and USD 204 million and USD 95 million, respectively, in the full year.
4 All periods exclude certain intellectual property rights and related other revenues which will be retained by Novartis and are now reported under Corporate activities, with 2013 reported results being restated for this impact. See page 22 of the CFR.
5�The cessation of depreciation and amortization had a positive impact of USD 28 million on operating income and USD 14 million on core operating income in the fourth quarter, and an impact of USD 73 million and USD 39 million on operating income and core operating income respectively in the full year.
14
�
�
�
A condensed financial report with the information listed in the index below can be found on our website at http://hugin.info/134323/R/1889668/668886.pdf.
Novartis Q4 and FY 2014 Condensed Financial Report Supplementary Data
|
INDEX
|
Page
|
|
GROUP AND DIVISIONAL OPERATING PERFORMANCE Q4 AND FY 2014
|
� |
|
Group
|
2
|
|
Pharmaceuticals
|
6
|
|
Alcon
|
13
|
|
Sandoz
|
16
|
|
Vaccines
|
18
|
|
Consumer Health
|
20
|
|
CASH FLOW AND GROUP BALANCE SHEET
|
23
|
|
INNOVATION REVIEW
|
25
|
|
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
� |
|
Condensed consolidated income statements
|
33
|
|
Condensed consolidated statements of comprehensive income
|
35
|
|
Condensed consolidated balance sheets
|
36
|
|
Condensed consolidated changes in equity
|
37
|
|
Condensed consolidated cash flow statements
|
38
|
|
Notes to condensed consolidated financial statements, including update on legal proceedings
|
40
|
|
SUPPLEMENTARY INFORMATION
|
54
|
|
CORE RESULTS
|
� |
|
Reconciliation from IFRS results to core results
|
56
|
|
Group
|
58
|
|
Pharmaceuticals
|
60
|
|
Alcon
|
62
|
|
Sandoz
|
64
|
|
Corporate continuing operations
|
66
|
|
Discontinuing operations
|
68
|
|
Vaccines
|
70
|
|
Consumer Health
|
72
|
|
Corporate -- discontinuing operations
|
74
|
|
ADDITIONAL INFORMATION
|
� |
|
Condensed consolidated changes in net debt / Share information
|
76
|
|
Free cash flow
|
77
|
|
Net sales of the top 20 Pharmaceuticals products
|
78
|
|
Pharmaceuticals sales by business franchise
|
80
|
|
Net sales by region
|
82
|
|
Currency translation rates / Income from associated companies
|
84
|
|
Vaccines segment 2013 comparative information
|
85
|
|
DISCLAIMER
|
86
|
15
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�
�
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as pipeline, will, momentum, recommended, on track, ongoing, outlook, expected, confident, positioned, pending, to be acquired, strategy, launches, launched, launch, focus, positive opinions, could, initiated, to evaluate, moves towards, designed, in the future, expects, expect, would, committed, or similar terms, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; potential shareholder returns or credit ratings; or regarding the potential completion of the announced transactions with GSK and CSL, or regarding potential future sales or earnings of any of the businesses involved in the transactions with GSK, Lilly or CSL, and regarding any potential strategic benefits, synergies or opportunities as a result of these transactions; or regarding potential future sales or earnings of the Novartis Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee that the announced transactions with GSK and CSL will be completed in the expected form or within the expected time frame or at all. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the transactions with GSK, Lilly or CSL. Neither can there be any guarantee that Novartis or any of the businesses involved in the transactions will achieve any particular financial results in the future. Nor can there be any guarantee that shareholders will achieve any particular level of shareholder returns.�Neither can there be any guarantee that the Novartis Group, or any of its divisions, will be commercially successful in the future, or achieve any particular credit rating. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including an unexpected failure to obtain necessary government approvals for the transactions, or unexpected delays in obtaining such approvals; the potential that the strategic benefits, synergies or opportunities expected from the announced transactions, including the divestment of our former Animal Health Division to Lilly, may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the Companys ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on the Company of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; unexpected manufacturing or quality issues; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, government investigations and intellectual property disputes; general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries; uncertainties regarding future global exchange rates, including as a result of recent changes in monetary policy by the Swiss National Bank; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; uncertainties regarding potential significant breaches of data security or disruptions of the Companys information technology systems; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
All product names appearing in italics are trademarks owned by or licensed to Novartis Group Companies. Neupogen� is a registered trademark of Amgen Inc. Stelara� is a registered trademark of Janssen Biotech, Inc. Jakafi� is a registered trademark of Incyte Corporation.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 130,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
Novartis issued its 2014 Annual Report today, and it is available on its website at www.novartis.com. Novartis will also today file its 2014 Annual Report on Form 20-F with the US Securities and Exchange Commission, and will post this document on www.novartis.com. Novartis shareholders may receive a hard copy of either of these documents, each of which contain our complete audited financial statements, free of charge, upon request.
16
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Important dates
February 27, 2015������������������������������Annual General Meeting
April 23, 2015������������������������������������First quarter results 2015
June 17-18, 2015��������������������������������Novartis investor event in Boston, US
July 21, 2015��������������������������������������Second quarter results 2015
October 27, 2015������������������������������ Third quarter results 2015
17
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Novartis�International�AG
Novartis�Global Communications
CH-4002 Basel
Switzerland
http://www.novartis.com
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CONDENSED FINANCIAL REPORT SUPPLEMENTARY DATA
Novartis Q4 and FY 2014 Condensed Financial Report Supplementary Data
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INDEX
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Page
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GROUP AND DIVISIONAL OPERATING PERFORMANCE Q4 AND FY 2014
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� |
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Group
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2
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Pharmaceuticals
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6
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Alcon
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13
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Sandoz
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16
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Vaccines
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18
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Consumer Health
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20
|
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CASH FLOW AND GROUP BALANCE SHEET
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23
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INNOVATION REVIEW
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25
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CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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� |
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Condensed consolidated income statements
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33
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Condensed consolidated statements of comprehensive income
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35
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Condensed consolidated balance sheets
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36
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Condensed consolidated changes in equity
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37
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Condensed consolidated cash flow statements
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38
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Notes to condensed consolidated financial statements, including update on legal proceedings
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40
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SUPPLEMENTARY INFORMATION
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54
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CORE RESULTS
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� |
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Reconciliation from IFRS results to core results
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56
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Group
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58
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Pharmaceuticals
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60
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Alcon
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62
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Sandoz
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64
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Corporate continuing operations
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66
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Discontinuing operations
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68
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Vaccines
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70
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Consumer Health
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72
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Corporate -- discontinuing operations
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74
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ADDITIONAL INFORMATION
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� |
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Condensed consolidated changes in net debt / Share information
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76
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Free cash flow
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77
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Net sales of the top 20 Pharmaceuticals products
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78
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Pharmaceuticals sales by business franchise
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80
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Net sales by region
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82
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Currency translation rates / Income from associated companies
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84
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Vaccines segment 2013 comparative information
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85
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DISCLAIMER
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86
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GROUP AND DIVISIONAL OPERATING PERFORMANCE
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Key figures
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� | � | � | � | � |
excl. Diagnostics1
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� | � |
Reported
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� | � | � | � | � |
excl. Diagnostics1
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� | � |
Reported
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� | ||||||||||||||||||||||
| � | � | � | � | Q4 2014 | 2 | � | � | Q4 2013 | � | � |
% change
|
� | � | � | Q4 2013 | � | � |
FY 20142
|
� | � |
FY 2013
|
� | � |
% change
|
� | � |
FY 2013
|
� | |||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc3
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� | � |
USD m
|
� | � |
USD m
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� | � |
USD m
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� | � |
USD
|
� | � |
cc3
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� | � |
USD m
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� | ||||||||||
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Net sales
|
� | � | � | 14 633 | � | � | � | 14 926 | � | � | � | - 2 | � | � | � | 4 | � | � | � | 15 078 | � | � | � | 57 996 | � | � | � | 57 355 | � | � | � | 1 | � | � | � | 3 | � | � | � | 57 920 | � |
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Continuing operations operating income
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� | � | � | 2 266 | � | � | � | 2 461 | � | � | � | - 8 | � | � | � | 1 | � | � | � | 2 461 | � | � | � | 11 156 | � | � | � | 11 636 | � | � | � | - 4 | � | � | � | 2 | � | � | � | 11 636 | � |
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Corporate income & expense, net
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� | � | � | 85 | � | � | � | - 128 | � | � |
nm
|
� | � |
nm
|
� | � | � | - 128 | � | � | � | - 67 | � | � | � | - 653 | � | � | � | 90 | � | � | � | 91 | � | � | � | - 653 | � | ||
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Discontinuing operations operating loss/income
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� | � | � | -1 179 | � | � | � | - 55 | � | � |
nm
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� | � |
nm
|
� | � | � | 40 | � | � | � | - 353 | � | � | � | - 312 | � | � | � | - 13 | � | � | � | -5 | � | � | � | - 73 | � | ||
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Group operating income
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� | � | � | 1 172 | � | � | � | 2 278 | � | � | � | - 49 | � | � | � | - 39 | � | � | � | 2 373 | � | � | � | 10 736 | � | � | � | 10 671 | � | � | � | 1 | � | � | � | 7 | � | � | � | 10 910 | � |
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As % of net sales
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� | � | � | 8.0 | % | � | � | 15.3 | % | � | � | � | � | � | � | � | � | � | � | 15.7 | % | � | � | 18.5 | % | � | � | 18.6 | % | � | � | � | � | � | � | � | � | � | � | 18.8 | % |
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Income from associated companies
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� | � | � | 579 | � | � | � | 154 | � | � | � | 276 | � | � | � | 277 | � | � | � | 154 | � | � | � | 1 920 | � | � | � | 600 | � | � | � | 220 | � | � | � | 220 | � | � | � | 600 | � |
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Interest expense
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� | � | � | - 188 | � | � | � | - 163 | � | � | � | - 15 | � | � | � | - 21 | � | � | � | - 163 | � | � | � | - 704 | � | � | � | - 683 | � | � | � | - 3 | � | � | � | - 6 | � | � | � | - 683 | � |
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Other financial income and expense
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� | � | � | 13 | � | � | � | - 42 | � | � |
nm
|
� | � |
nm
|
� | � | � | - 42 | � | � | � | - 31 | � | � | � | - 92 | � | � | � | 66 | � | � | � | 31 | � | � | � | - 92 | � | ||
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Taxes
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� | � | � | - 89 | � | � | � | - 228 | � | � | � | 61 | � | � | � | 56 | � | � | � | - 264 | � | � | � | -1 641 | � | � | � | -1 352 | � | � | � | - 21 | � | � | � | - 28 | � | � | � | -1 443 | � |
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Net income
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� | � | � | 1 487 | � | � | � | 1 999 | � | � | � | - 26 | � | � | � | - 16 | � | � | � | 2 058 | � | � | � | 10 280 | � | � | � | 9 144 | � | � | � | 12 | � | � | � | 19 | � | � | � | 9 292 | � |
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EPS (USD)
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� | � | � | 0.62 | � | � | � | 0.81 | � | � | � | -23 | � | � | � | -13 | � | � | � | 0.83 | � | � | � | 4.21 | � | � | � | 3.70 | � | � | � | 14 | � | � | � | 20 | � | � | � | 3.76 | � |
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Free cash flow3
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� | � | � | 4 419 | � | � | � | 3 130 | � | � | � | 41 | � | � | � | � | � | � | � | 3 319 | � | � | � | 10 762 | � | � | � | 9 592 | � | � | � | 12 | � | � | � | � | � | � | � | 9 945 | � |
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Core3
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� | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � |
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Operating income
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� | � | � | 3 322 | � | � | � | 3 293 | � | � | � | 1 | � | � | � | 9 | � | � | � | � | � | � | � | 14 616 | � | � | � | 14 191 | � | � | � | 3 | � | � | � | 8 | � | � | � | � | � |
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As % of net sales
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� | � | � | 22.7 | % | � | � | 22.1 | % | � | � | � | � | � | � | � | � | � | � | � | � | � | � | 25.2 | % | � | � | 24.7 | % | � | � | � | � | � | � | � | � | � | � | � | � |
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Net income
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� | � | � | 2 914 | � | � | � | 2 892 | � | � | � | 1 | � | � | � | 9 | � | � | � | � | � | � | � | 12 755 | � | � | � | 12 351 | � | � | � | 3 | � | � | � | 8 | � | � | � | � | � |
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EPS (USD)
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� | � | � | 1.21 | � | � | � | 1.18 | � | � | � | 3 | � | � | � | 12 | � | � | � | � | � | � | � | 5.23 | � | � | � | 5.01 | � | � | � | 4 | � | � | � | 10 | � | � | � | � | � |
�����������
Following the announcement of the transactions with GlaxoSmithKline plc (GSK) and Eli Lilly and Company (Lilly) on April 22, 2014 (and the subsequent transaction with CSL Limited), in order to comply with International Financial Reporting Standards (IFRS), Novartis separated the Groups reported financial data for the current and prior years into discontinuing and continuing operations, defined on page 22.
The transaction with Lilly closed on January 1, 2015 with the divestment of Animal Health. Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with CSL Limited (CSL) to be completed in the second half of 2015, subject to customary closing conditions including regulatory approvals. Despite the IFRS required presentation of discontinuing versus continuing operations, until the GSK and CSL transactions are closed, Novartis remains fully committed to all Group activities.
In addition, all growth rates related to Novartis Group and Vaccines Division results contained within this release, unless otherwise noted, refer to 2013 data excluding the blood transfusion diagnostics business, to help illustrate performance on a comparable basis.
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1 All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 85.
2 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date.
3 Constant currencies (cc), core results, free cash flow and 2013 data excluding the blood transfusion diagnostics unit are non-IFRS measures. An explanation of non-IFRS measures and reconciliation tables can be found beginning on page 54.
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Fourth quarter
Group net sales
Group net sales amounted to USD 14.6 billion (-2%, +4% cc) in the fourth quarter. Growth Products1 contributed USD 4.7 billion or 32% of Group net sales, up 14% (USD) over the prior-year quarter.
Corporate income and expense, net
Corporate income and expense, which includes the cost of Group management and central services, amounted to a net income of USD 85 million in the fourth quarter compared to a net expense of USD 128 million in the prior-year period, mainly due to a USD 248 million gain in the quarter from selling a Novartis Venture Fund investment.
Group operating income
Group operating income decreased 49% (-39% cc) to USD 1.2 billion, mainly due to an exceptional pre-tax impairment charge of USD 1.1 billion related to the pending divestment to CSL of the influenza vaccines business. Currency had a negative impact of 10 percentage points, primarily due to the weakening of the euro, yen and ruble against the US dollar. Operating income margin decreased to 8.0% of net sales, down 6.4 percentage points (cc) from the prior-year quarter mainly on account of the exceptional influenza vaccines business impairment charge. Currency had a negative impact of 0.9 percentage points, resulting in a net decrease of 7.3 percentage points. The cessation of depreciation and amortization charges related to the discontinuing operations had a positive impact of USD 101 million for the quarter, improving the operating income margin by 0.7 percentage points (cc).
The adjustments made to Group operating income to arrive at core operating income increased to USD 2.2 billion (2013: USD 1.0 billion), mainly on account of the exceptional USD 1.1 billion impairment charge for the influenza vaccines business in the fourth quarter of 2014.
Excluding these items, Group core operating income increased 1% (+9% cc) to USD 3.3 billion. Core operating income margin in constant currencies increased 1.1 percentage points mainly due to lower functional costs driven by productivity programs, partly offset by unfavorable other income and expense. The cessation of depreciation and amortization charges related to the discontinuing operations had a positive impact of USD 49 million, improving the core operating income margin by 0.3 percentage points (cc). Currency had a negative impact of 0.5 percentage points, resulting in a net increase of 0.6 percentage points to 22.7% of net sales.
Income from associated companies
Income from associated companies amounted to USD 579 million compared to USD 154 million in the fourth quarter of 2013. The increase was mainly due to a gain of USD 421 million recognized on the sale of the shares of LTS Lohmann Therapie-Systeme AG in November 2014. The contribution from the investment in Roche amounted to USD 153 million compared to USD 168 million in the prior-year quarter.
Core income from associated companies increased from USD 198 million in the prior-year period to USD 209 million in the fourth quarter of 2014.
Interest expense and other financial income/expense
Interest expense increased to USD 188 million from USD 163 million in the prior-year period due to recent bond issues. Other financial income and expense amounted to a net income of USD 13 million compared to a net expense of USD 42 million in the 2013 period, mainly due to hedging gains.
Taxes
The total Groups tax rate (taxes as percentage of pre-tax income) in the fourth quarter decreased to 5.6% from 10.2% in the prior-year quarter, mainly due to the USD 1.1 billion impairment charge for the influenza vaccines business, other exceptional items in the quarter and the effect of adjusting to the full-year tax rate which was less than the previously estimated full-year rate.
The Groups core tax rate (taxes as percentage of pre-tax income) increased to 13.2% from 12.0% in the prior-year quarter.
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1�"Growth Products" comprise products launched in 2009 or later, or products with exclusivity until at least 2018 in key markets (EU, US, Japan) (except Sandoz, which includes only products launched in the last 24 months).
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Net income and EPS
Group net income of USD 1.5 billion was down 26% (-16% cc), mainly due to lower operating income, partially offset by higher income from associated companies, which included a USD 0.4 billion pre-tax gain from the divestment of the shareholding in LTS Lohmann Therapie-Systeme AG and lower tax expense.
EPS was USD 0.62 (-23%, -13% cc), down slightly less than net income due to lower average outstanding shares and lower minority interest.
Group core net income of USD 2.9 billion was up 1% (+9% cc), in line with core operating income.
Core EPS was USD 1.21 (+3%, +12% cc), growing ahead of core net income mainly due to lower average outstanding shares and lower minority interest.
Comparing results for the fourth quarter of 2014 and the same period in 2013 including the blood transfusion diagnostics unit, Group total net sales decreased 3% in USD (+3% cc), Group total operating income was down 51% (-42% cc), Group total net income decreased 28% (-18% cc), and Group total EPS decreased 25% (-16% cc), down slightly less than Group total net income due to the lower average number of outstanding shares and lower minority interest. The tax rate in the fourth quarter of 2014 was 5.6%, compared to the prior-year period tax rate including the divested blood transfusion diagnostics unit of 11.4%.
Full year
Group net sales
Group net sales increased 1% (+3% cc) to USD 58.0 billion in the full year. Growth Products contributed USD 18.6 billion or 32% of Group net sales, up 18% (USD) over 2013. Loss of exclusivity, including for Diovan, impacted sales by approximately USD 2.4 billion.
Corporate income and expense, net
Corporate income and expense amounted to a net expense of USD 67 million in 2014 compared to USD 653 million in the prior year, mainly due to a USD 456 million increase in other revenues principally related to the retained Vaccines intellectual property rights, including a USD 302 million commercial settlement gain and a USD 248 million gain from selling a Novartis Venture Fund investment.
Group operating income
Group operating income increased 1% (+7% cc) to USD 10.7 billion. The USD 0.9 billion exceptional gain in the first quarter from the divestment of the blood transfusion diagnostics unit to Grifols S.A. was more than offset by an exceptional pre-tax impairment charge of USD 1.1 billion in the fourth quarter related to the pending divestment to CSL of the influenza vaccines business. The negative currency impact of 6 percentage points was mainly due to the weakening of emerging market currencies (especially the ruble) and the yen against the US dollar. Operating income margin was 18.5% of net sales, up 0.8 percentage points (cc) from the prior-year period. Currency had a negative impact of 0.9 percentage points, resulting in a net decrease of 0.1 percentage points. The cessation of depreciation and amortization charges related to the discontinuing operations had a positive impact of USD 277 million for the full year, improving operating income margin by 0.5 percentage points (cc).
The adjustments made to Group operating income to arrive at core operating income amounted to USD 3.9 billion (2013: USD 3.5 billion). These adjustments include a USD 0.9 billion pre-tax gain from the divestment of the blood transfusion diagnostics unit and the USD 0.3 billion commercial settlement gain, which were offset by the exceptional USD 1.1 billion impairment charge for the influenza vaccines business.
Excluding these items, Group core operating income increased 3% (+8% cc) to USD 14.6 billion. Core operating income margin in constant currencies increased 1.2 percentage points; currency had a negative currency impact of 0.7 percentage points, resulting in a net increase of 0.5 percentage points to 25.2% of net sales. The cessation of depreciation and amortization charges related to the discontinuing operations had a positive impact of USD 134 million, improving the core operating income margin by 0.2 percentage points (cc).
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Income from associated companies
Income from associated companies amounted to USD 1.9 billion in 2014, compared to USD 600 million in 2013. The increase was mainly due to the gains recognized on the sale of shares of LTS Lohmann Therapie-Systeme AG and on the sale of the shares of Idenix Pharmaceuticals, Inc., which amounted to USD 421 million and USD 812 million, respectively. An additional income of USD 64 million was recorded on investments in associated companies held by the Novartis Venture Funds, which have been accounted at fair value from January 1, 2014 onwards, consistent with other investments held by these Funds. The contribution from the investment in Roche of USD 599 million was approximately in line with the prior-year level.
Core income from associated companies increased to USD 945 million from USD 877 million in the prior-year period.
Interest expense and other financial income/expense
Interest expense increased slightly to USD 704 million from USD 683 million in the prior year. Other financial income and expense amounted to a net expense of USD 31 million compared to a net expense of USD 92 million in 2013, mainly as a result of hedging gains.
Taxes
The total Groups tax rate in the full year of 2014 increased to 13.8% from 12.9% in 2013, principally due to the impact of taxes on the various exceptional gains and impairments and other exceptional charges which occurred during the year.
The core tax rate increased slightly to 14.0% from 13.9% in 2013.
Net income and EPS
Group net income of USD 10.3 billion was up 12% (+19% cc), growing ahead of operating income mainly due to higher income from associated companies, which included a pre-tax gain of USD 0.8 billion from the sale of the shares of Idenix Pharmaceuticals, Inc. to Merck & Co., and a pre-tax gain of USD 0.4 billion from the divestment of the shareholding in LTS Lohmann Therapie-Systeme AG, partly offset by an increase in tax expense.
EPS was up 14% (+20% cc) to USD 4.21, growing ahead of net income due to lower average outstanding shares and lower minority interest.
Group core net income of USD 12.8 billion was up 3% (+8% cc), in line with core operating income.
Core EPS was USD 5.23 (+4%, +10% cc), growing ahead of core net income due to lower average outstanding shares and lower minority interest.
Comparing results for the full year of 2014 and the same period in 2013 including the blood transfusion diagnostics unit, Group total net sales remained stable in USD (0%, +2% cc), Group total operating income was down 2% (+5% cc), Group total net income increased 11% (+17% cc) and Group total EPS grew slightly ahead of net income at 12% (+18% cc) due to lower average outstanding shares and lower minority interest. The tax rate in the full year of 2014 was 13.8%, compared to the prior-year period tax rate including the divested blood transfusion diagnostics unit of 13.4%.
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CONTINUING OPERATIONS1
Pharmaceuticals
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
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� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
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� | � |
USD m
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� | � |
USD
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� | � |
cc
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� | � |
USD m
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� | � |
USD m
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� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Net sales
|
� | � | � | 7 860 | � | � | � | 8 323 | � | � | � | -6 | � | � | � | 0 | � | � | � | 31 791 | � | � | � | 32 214 | � | � | � | -1 | � | � | � | 1 | � |
|
Operating income
|
� | � | � | 1 611 | � | � | � | 2 013 | � | � | � | -20 | � | � | � | -14 | � | � | � | 8 471 | � | � | � | 9 376 | � | � | � | -10 | � | � | � | -5 | � |
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��As % of net sales
|
� | � | � | 20.5 | � | � | � | 24.2 | � | � | � | � | � | � | � | � | � | � | � | 26.6 | � | � | � | 29.1 | � | � | � | � | � | � | � | � | � |
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Core operating income
|
� | � | � | 1 977 | � | � | � | 2 133 | � | � | � | -7 | � | � | � | 0 | � | � | � | 9 514 | � | � | � | 9 523 | � | � | � | 0 | � | � | � | 4 | � |
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��As % of net sales
|
� | � | � | 25.2 | � | � | � | 25.6 | � | � | � | � | � | � | � | � | � | � | � | 29.9 | � | � | � | 29.6 | � | � | � | � | � | � | � | � | � |
Fourth quarter
Net sales
Pharmaceuticals net sales were USD 7.9 billion (-6%, 0% cc) with volume growth of 8 percentage points offset by the negative impact of generic competition (-8 percentage points), largely for Diovan monotherapy and Exforge (US generic entry for Exforge on September 30, 2014 and for Exforge HCT on December 1, 2014). Growth products2 generated USD 3.6 billion of division net sales, growing 18% (cc) over the same period last year. These products which include Gilenya, Afinitor, Tasigna, Galvus, Lucentis, Xolair, the COPD (chronic obstructive pulmonary disease) portfolio3 and Jakavi contributed 46% of division net sales, compared to 39% in the 2013 quarter.
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Regionally, European sales (USD 2.7 billion, +5% cc) were strong, driven by Growth Products. US sales (USD 2.4 billion, -8% cc) declined due to generic competition for Diovan monotherapy, Exforge, Myfortic and Ritalin, which more than offset growth for Gleevec/Glivec, Gilenya, Afinitor and Tasigna. Japan sales (USD 0.6 billion, -20% cc) decreased, mainly due to a continued decline in Diovan sales, a biennial price cut for many brands and the impact of issues related to investigator initiated trials. Emerging Growth Markets (USD 2.2 billion, +13% cc) continued to perform strongly.
Oncology sales grew 10% (cc) to USD 3.1 billion, driven mainly by Tasigna (USD 428 million, +30% cc), Afinitor (USD 426 million, +24% cc) and Gleevec/Glivec (USD 1.2 billion, +5% cc). In Specialty Care, Gilenya (USD 666 million, +32% cc) grew double-digit in the US and most ex-US markets, and Lucentis sales (USD 588 million, +1% cc) grew slightly, driven by the uptake in non-AMD indications, offsetting the impact of wet AMD competition. Primary Care strategic franchise performance (USD 0.7 billion, +14% cc) was underpinned by continued strong uptake of the COPD portfolio3 (USD 149 million, +94% cc) and Xolair (USD 200 million, +25% cc), partly offset by Galvus (USD 295 million, -1% cc), which Novartis stopped distributing in Germany in July.
Operating income
Operating income of USD 1.6 billion (-20%, -14% cc) declined principally due to exceptional items including net impairments of USD 157 million (primarily related to DEB025, which was terminated as a result of a hepatitis C virus strategy review) and net restructuring charges of USD 207 million (mainly related to a voluntary retirement program in Japan). Prior-year adjustments amounted to USD 120 million, principally due to the amortization of intangible assets of USD 70 million and impairment charges of USD 86 million, partially offset by gains on selling financial assets of USD 125 million.
Core operating income was USD 2.0 billion (-7%, 0% cc). Core margin in constant currencies remained in line with the prior year; currency had a negative impact of 0.4 percentage points, resulting in a core margin of 25.2% of net sales.
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1�Continuing operations do not yet include the results from oncology assets to be acquired from GSK on closing of the transaction or the results from the 36.5% interest in the GSK/Novartis consumer healthcare OTC joint venture interest which will be created at the same time.
2�"Growth products" comprise products launched in 2009 or later, or products with exclusivity until at least 2018 in key markets (EU, US, Japan).
3�The COPD portfolio includes Onbrez Breezhaler/Arcapta Neohaler, Seebri Breezhaler and Ultibro Breezhaler.
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Core gross margin as a percentage of net sales improved by 0.2 percentage points (cc). Core R&D expenses improved by 0.3 percentage points (cc), and core M&S and core G&A expenses remained unchanged, marking another quarter of productivity programs and effective resource allocation. Core Other Income and Expense, net decreased the margin by 0.5 percentage points (cc).
Full year
Net sales
Pharmaceuticals delivered net sales of USD 31.8 billion (-1%, +1% cc) for the full year, driven by volume growth (+7 percentage points) and pricing (+1 percentage points), offset by the impact of generic competition (-7 percentage points). Growth Products continued to drive performance and rejuvenate the portfolio, generating USD 13.7 billion of division net sales, up 17% (cc) over the previous year.
Europe (USD 11.2 billion, +3% cc) benefited from the performance of growth products, partially offset by generic competition. The US (USD 9.8 billion, -5% cc) was impacted by generic competition for Diovan, Myfortic, Ritalin and TOBI nebulizer solution. Japans performance (USD 2.7 billion, -11% cc) was mainly impacted by a continued decline in Diovan sales, the biennial price decrease and the impact of issues related to investigator initiated trials. Emerging Growth Markets (USD 8.1 billion, +11% cc) showed double-digit growth, notably in Turkey, Brazil and China.
Operating income
Operating income was USD 8.5 billion (-10%, -5% cc) for the full year. Included in operating income was USD 576 million of net restructuring charges related to redeployment initiatives and a voluntary retirement program in Japan, USD 266 million of net impairment charges, USD 157 million for the US Healthcare Fee exceptional charge and the USD 125 million charge related to the Lucentis investigation in Italy (which nevertheless continues to be vigorously defended), partly offset by exceptional divestment gains of USD 237 million. The full year of 2013 had net adjustments of USD 147 million.
Core operating income was USD 9.5 billion (0%, +4% cc), generating core operating leverage in constant currency due to productivity programs and effective resource allocation. Core margin in constant currencies improved by 1.1 percentage points; currency had a negative impact of 0.8 percentage points, resulting in a net margin expansion of 0.3 percentage points to 29.9% of net sales.
Core gross margin as a percentage of net sales remained stable from the prior year. Core R&D expenses improved by 0.7 percentage points (cc), reflecting prior-year increased investments in late-stage clinical trials, as well as continued productivity efforts. Core M&S and core G&A expenses improved by 0.8 percentage points (cc), as continuing productivity efforts and funding reduction for non-strategic brands offset additional investments in new product launches. Core Other Income and Expense, net decreased the margin by 0.4 percentage points (cc).
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Pharmaceuticals product review
The information in this release reflects 2014 franchise structure within the Pharmaceuticals Division. As of January 2015, the Pharmaceuticals Division includes the following areas: Oncology, Immunology and Dermatology, Cardio-Metabolic, Retina, Neuroscience, Respiratory, Cell and Gene Therapies, and Established Medicines. The presentation of franchise performance using the new structure will commence with the first quarter 2015 earnings release with comparable 2014 information restated.
All comments below focus on fourth quarter movements.
PRIMARY CARE
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
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� | ||||||||||||
| � | � | � |
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� | � |
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� | � |
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� | � |
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� | � |
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� | � |
USD
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� | � |
cc
|
� | ||||||||
|
Onbrez Breezhaler/Arcapta Neohaler
|
� | � | � | 56 | � | � | � | 53 | � | � | � | 6 | � | � | � | 15 | � | � | � | 220 | � | � | � | 192 | � | � | � | 15 | � | � | � | 17 | � |
|
Seebri Breezhaler
|
� | � | � | 42 | � | � | � | 25 | � | � | � | 68 | � | � | � | 88 | � | � | � | 146 | � | � | � | 58 | � | � | � | 152 | � | � | � | 159 | � |
|
Ultibro Breezhaler
|
� | � | � | 51 | � | � | � | 6 | � | � |
nm
|
� | � |
nm
|
� | � | � | 118 | � | � | � | 6 | � | � |
nm
|
� | � |
nm
|
� | ||||
|
COPD portfolio
|
� | � | � | 149 | � | � | � | 84 | � | � | � | 77 | � | � | � | 94 | � | � | � | 484 | � | � | � | 256 | � | � | � | 89 | � | � | � | 93 | � |
|
Galvus
|
� | � | � | 295 | � | � | � | 328 | � | � | � | -10 | � | � | � | -1 | � | � | � | 1 224 | � | � | � | 1 200 | � | � | � | 2 | � | � | � | 6 | � |
|
Xolair1
|
� | � | � | 200 | � | � | � | 173 | � | � | � | 16 | � | � | � | 25 | � | � | � | 777 | � | � | � | 613 | � | � | � | 27 | � | � | � | 30 | � |
|
TOBI
|
� | � | � | 65 | � | � | � | 88 | � | � | � | -26 | � | � | � | -23 | � | � | � | 281 | � | � | � | 387 | � | � | � | -27 | � | � | � | -26 | � |
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Other
|
� | � | � | 8 | � | � | � | 10 | � | � | � | -20 | � | � | � | 2 | � | � | � | 46 | � | � | � | 40 | � | � | � | 15 | � | � | � | 20 | � |
|
Total strategic franchise products
|
� | � | � | 717 | � | � | � | 683 | � | � | � | 5 | � | � | � | 14 | � | � | � | 2 812 | � | � | � | 2 496 | � | � | � | 13 | � | � | � | 16 | � |
|
Diovan
|
� | � | � | 379 | � | � | � | 843 | � | � | � | -55 | � | � | � | -53 | � | � | � | 2 345 | � | � | � | 3 524 | � | � | � | -33 | � | � | � | -32 | � |
|
Exforge
|
� | � | � | 298 | � | � | � | 372 | � | � | � | -20 | � | � | � | -14 | � | � | � | 1 396 | � | � | � | 1 456 | � | � | � | -4 | � | � | � | -2 | � |
|
Tekturna/ Rasilez
|
� | � | � | 47 | � | � | � | 59 | � | � | � | -20 | � | � | � | -15 | � | � | � | 207 | � | � | � | 290 | � | � | � | -29 | � | � | � | -27 | � |
|
Other
|
� | � | � | 274 | � | � | � | 352 | � | � | � | -22 | � | � | � | -16 | � | � | � | 1 201 | � | � | � | 1 312 | � | � | � | -8 | � | � | � | -6 | � |
|
Established medicines
|
� | � | � | 998 | � | � | � | 1 626 | � | � | � | -39 | � | � | � | -34 | � | � | � | 5 149 | � | � | � | 6 582 | � | � | � | -22 | � | � | � | -20 | � |
|
Total Primary Care products
|
� | � | � | 1 715 | � | � | � | 2 309 | � | � | � | -26 | � | � | � | -20 | � | � | � | 7 961 | � | � | � | 9 078 | � | � | � | -12 | � | � | � | -10 | � |
nm = not meaningful
Onbrez Breezhaler/Arcapta Neohaler (USD 56 million, +15% cc) continued to grow worldwide as a once-daily bronchodilator of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). Onbrez Breezhaler/Arcapta Neohaler (indacaterol), a long-acting beta-2 agonist (LABA) approved in over 100 countries, is delivered via the low-resistance Breezhaler/Neohaler inhalation device.
Seebri Breezhaler�(USD 42 million, +88% cc), a once-daily inhaled long-acting muscarinic antagonist (LAMA) indicated as a�maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD, showed strong growth in the quarter. Delivered via the Breezhaler inhalation device, Seebri Breezhaler (glycopyrronium bromide) is approved in over 70 countries across Europe, Japan, Canada, Latin America, Asia, Australia and the Middle East, and a regulatory application has been submitted in the US. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.
Ultibro Breezhaler�(USD 51 million) is a LABA/LAMA approved as a first-in-class once-daily dual bronchodilator in over 50 countries outside the US (including EU and Japan) and launched in over 25 countries (including the UK, Germany, Japan and Canada). Ultibro Breezhaler is a fixed-dose combination of indacaterol and glycopyrronium bromide, and in the EU, is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. A regulatory application has been submitted in the US.
The COPD portfolio, which includes Onbrez Breezhaler/Arcapta Neohaler, Seebri Breezhaler and Ultibro Breezhaler,�grew 94% (cc) to USD 149 million in the fourth quarter.
�
1�Revenue reflects Xolair sales for all indications (i.e. Xolair SAA and Xolair CSU, which are managed by the Integrated Hospital Care franchise).
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Galvus Group (USD 295 million, -1% cc), which includes Galvus, an oral treatment for type 2 diabetes, and Eucreas, a single-pill combination of vildagliptin (the active ingredient in Galvus) and metformin, saw sales decline, driven by the distribution stop in the German market on July 1, 2014. Sales for the first six months of 2014 in Germany were USD 57 million. Galvus delivered a solid performance overall, with strong growth in many markets around the world. The focus for Galvus remains on patients whose diabetes is uncontrolled on metformin, as well as on expansion of usage in key segments, such as elderly and renal-impaired patients. Galvus Group is currently approved in more than 120 countries.
Xolair (USD 200 million, +25% cc), currently approved in more than 90 countries as a treatment for moderate-to-severe or severe persistent allergic asthma, continued to grow strongly in Canada, Europe and Latin America. Xolair is also approved in the EU, Switzerland and 35 other countries as a treatment for chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), for which it is approved in the US, Canada and Australia. Novartis co-promotes Xolair with Genentech/Roche in the US and shares a portion of the operating income, but does not book US sales.
TOBI Group (USD 65 million, -23% cc), which includes TOBI nebulizer solution formulation and TOBI Podhaler, a dry powder formulation of the antibiotic tobramycin for the management of cystic fibrosis sales, declined�due to generic competition for TOBI nebulizer solution formulation. Approved in over 60 countries, TOBI Podhaler contributed 65% of total TOBI Group sales in the fourth quarter.
Diovan Group�(USD 379 million, -53% cc), consisting of Diovan monotherapy and the combination product Co-Diovan/Diovan HCT, saw a continued sales decline worldwide due to generic competition in most markets including the US (following July 7, 2014 Diovan monotherapy generic entry), many EU countries and Japan (generic entry in June 2014), compounded in Japan by the impact of issues related to investigator initiated trials.
Exforge Group (USD 298 million, -14% cc), which includes Exforge and Exforge HCT, declined due to the entry of generic competition in the US for both Exforge (generic entry in October 2014) and Exforge HCT (November 2014). Sales remained stable in the EU and continued to experience double-digit growth in China and a number of emerging markets. Exforge is now available in more than 100 countries. Exforge HCT is available in over 60 countries.
ONCOLOGY
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
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� | ||||||||||||
| � | � | � |
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� | � |
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� | � |
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|
� | � |
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|
� | � |
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|
� | � |
USD m
|
� | � |
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|
� | � |
cc
|
� | ||||||||
|
Gleevec/Glivec
|
� | � | � | 1 237 | � | � | � | 1 227 | � | � | � | 1 | � | � | � | 5 | � | � | � | 4 746 | � | � | � | 4 693 | � | � | � | 1 | � | � | � | 2 | � |
|
Tasigna
|
� | � | � | 428 | � | � | � | 352 | � | � | � | 22 | � | � | � | 30 | � | � | � | 1 529 | � | � | � | 1 266 | � | � | � | 21 | � | � | � | 24 | � |
|
Subtotal Bcr-Abl franchise
|
� | � | � | 1 665 | � | � | � | 1 579 | � | � | � | 5 | � | � | � | 10 | � | � | � | 6 275 | � | � | � | 5 959 | � | � | � | 5 | � | � | � | 7 | � |
|
Sandostatin
|
� | � | � | 416 | � | � | � | 416 | � | � | � | 0 | � | � | � | 5 | � | � | � | 1 650 | � | � | � | 1 589 | � | � | � | 4 | � | � | � | 6 | � |
|
Afinitor/Votubia
|
� | � | � | 426 | � | � | � | 361 | � | � | � | 18 | � | � | � | 24 | � | � | � | 1 575 | � | � | � | 1 309 | � | � | � | 20 | � | � | � | 22 | � |
|
Exjade
|
� | � | � | 243 | � | � | � | 244 | � | � | � | 0 | � | � | � | 5 | � | � | � | 926 | � | � | � | 893 | � | � | � | 4 | � | � | � | 6 | � |
|
Femara
|
� | � | � | 98 | � | � | � | 100 | � | � | � | -2 | � | � | � | 6 | � | � | � | 380 | � | � | � | 384 | � | � | � | -1 | � | � | � | 2 | � |
|
Jakavi
|
� | � | � | 84 | � | � | � | 47 | � | � | � | 79 | � | � | � | 91 | � | � | � | 279 | � | � | � | 163 | � | � | � | 71 | � | � | � | 72 | � |
|
Zometa
|
� | � | � | 57 | � | � | � | 94 | � | � | � | -39 | � | � | � | -34 | � | � | � | 264 | � | � | � | 600 | � | � | � | -56 | � | � | � | -55 | � |
|
Proleukin
|
� | � | � | 15 | � | � | � | 26 | � | � | � | -42 | � | � | � | -42 | � | � | � | 74 | � | � | � | 91 | � | � | � | -19 | � | � | � | -19 | � |
|
Zykadia
|
� | � | � | 12 | � | � | � | 0 | � | � |
nm
|
� | � |
nm
|
� | � | � | 31 | � | � | � | 0 | � | � |
nm
|
� | � |
nm
|
� | ||||
|
Other
|
� | � | � | 66 | � | � | � | 60 | � | � | � | 10 | � | � | � | 11 | � | � | � | 249 | � | � | � | 228 | � | � | � | 9 | � | � | � | 10 | � |
|
Total Oncology products
|
� | � | � | 3 082 | � | � | � | 2 927 | � | � | � | 5 | � | � | � | 10 | � | � | � | 11 703 | � | � | � | 11 216 | � | � | � | 4 | � | � | � | 6 | � |
nm = not meaningful
Our Bcr-Abl franchise, consisting of Tasigna and Gleevec/Glivec, reached USD 1.7 billion in sales (+10% cc) in the fourth quarter, driven by growth of both products.
Gleevec/Glivec (USD 1.2 billion, +5% cc) experienced modest growth in the fourth quarter, driven mainly by the US. In the US, Novartis Pharmaceuticals Corporation has settled its litigation with a subsidiary of Sun Pharmaceutical Industries Ltd. relating to Novartis patents covering the use of certain polymorphic forms of Gleevec/Glivec, which expire in 2019 (including pediatric exclusivity). The basic compound patent for Gleevec/Glivec expires in the US on July 4, 2015. As a result of the settlement, Novartis will permit Suns subsidiary to market a generic version of Gleevec/Glivec in the US on February 1, 2016.
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Tasigna (USD 428 million, +30% cc) double-digit performance in the fourth quarter was driven by strong growth in the US and other markets. Tasigna is a more effective, targeted therapy than Gleevec/Glivec for adult patients newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase or for adult patients in the chronic or accelerated phase who are resistant or intolerant to at least one prior therapy including Gleevec/Glivec.
Sandostatin (USD 416 million, +5% cc) continued to benefit from the increasing use of Sandostatin LAR1 in key markets. Sandostatin is a somatostatin analogue used to treat patients with acromegaly as well as neuroendocrine tumors (NET). In NET, it is used for both the treatment of patients with symptoms of carcinoid syndrome and those with advanced NET of the midgut or unknown primary tumor location (currently approved in 47 countries). An enhanced presentation of Sandostatin LAR, which includes an improved diluent, safety needle and vial adapter, has been approved in 58 countries, with additional filings underway.
Afinitor/Votubia�(USD 426 million, +24% cc) performance in the fourth quarter was driven by strong growth in the US, Japan and other markets. Afinitor is an oral inhibitor of the mTOR pathway approved in combination with exemestane for the treatment of patients with HR+/HER2- advanced breast cancer after failure with a non-steroidal aromatase inhibitor, for advanced renal cell carcinoma following vascular endothelial growth factor-targeted therapy and for the treatment of advanced pancreatic NET. Afinitor is also approved for subependymal giant cell astrocytoma (SEGA) and renal angiomyolipoma associated with tuberous sclerosis complex. Everolimus, the active ingredient in Afinitor/Votubia, is available under the trade names Zortress/Certican for use in other non-oncology indications and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.
Exjade (USD 243 million, +5% cc), a once-daily oral therapy for chronic transfusional iron overload approved in more than 100 countries, is also approved for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia in more than 70 countries, with additional regulatory reviews underway. Regulatory applications have been submitted in the US, Canada and Colombia for a new film-coated tablet formulation that can be swallowed. Applications for the new formulation are currently being filed in other countries.
Jakavi (USD 84 million, +91% cc), an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases, experienced very strong growth in the quarter. It is the first JAK inhibitor indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Jakavi (ruxolitinib) is currently approved in more than 65 countries, including EU member states, Japan, Canada, Australia, Mexico and Argentina. Regulatory applications have been submitted in the EU, Switzerland and Japan for Jakavi in polycythemia vera. Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the US.
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1�Long acting release
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SPECIALTY CARE
Neuroscience
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
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� | � |
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� | � |
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� | � |
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� | � |
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� | � |
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� | � |
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� | � |
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� | � |
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� | ||||||||
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Gilenya
|
� | � | � | 666 | � | � | � | 527 | � | � | � | 26 | � | � | � | 32 | � | � | � | 2 477 | � | � | � | 1 934 | � | � | � | 28 | � | � | � | 30 | � |
|
Exelon/Exelon Patch
|
� | � | � | 240 | � | � | � | 250 | � | � | � | -4 | � | � | � | 0 | � | � | � | 1 009 | � | � | � | 1 032 | � | � | � | -2 | � | � | � | -1 | � |
|
Comtan/Stalevo
|
� | � | � | 89 | � | � | � | 103 | � | � | � | -14 | � | � | � | -5 | � | � | � | 371 | � | � | � | 401 | � | � | � | -7 | � | � | � | -4 | � |
|
Extavia
|
� | � | � | 43 | � | � | � | 37 | � | � | � | 16 | � | � | � | 20 | � | � | � | 177 | � | � | � | 159 | � | � | � | 11 | � | � | � | 11 | � |
|
Other
|
� | � | � | 16 | � | � | � | 21 | � | � | � | -24 | � | � | � | -24 | � | � | � | 66 | � | � | � | 78 | � | � | � | -15 | � | � | � | -15 | � |
|
Total strategic franchise products
|
� | � | � | 1 054 | � | � | � | 938 | � | � | � | 12 | � | � | � | 18 | � | � | � | 4 100 | � | � | � | 3 604 | � | � | � | 14 | � | � | � | 15 | � |
|
Established medicines
|
� | � | � | 100 | � | � | � | 112 | � | � | � | -11 | � | � | � | -2 | � | � | � | 409 | � | � | � | 444 | � | � | � | -8 | � | � | � | -3 | � |
|
Total Neuroscience products
|
� | � | � | 1 154 | � | � | � | 1 050 | � | � | � | 10 | � | � | � | 16 | � | � | � | 4 509 | � | � | � | 4 048 | � | � | � | 11 | � | � | � | 13 | � |
Gilenya (USD 666 million, +32% cc), the first once-daily oral therapy to treat relapsing forms of multiple sclerosis (MS), continued to show strong double-digit growth as the market moves towards oral treatments with higher efficacy and away from more traditional injectable therapies. Gilenya continued to see volume growth through new patient initiations (includes new patient starts, i.e. na�ve patients, plus switches) in both the US and ex-US markets. Gilenya is approved in over 80 countries around the world and it is estimated that Gilenya has been used to treat approximately 114,000 patients in clinical trials and in a post-marketing setting, with a total patient exposure of approximately 195,000 patient years. Gilenya is licensed from Mitsubishi Tanabe Pharma.
Exelon/Exelon Patch (USD 240 million, 0% cc) sales remained stable in the fourth quarter due to generic competition for Exelon Patch in the EU offsetting a solid performance for Exelon Patch in the US. Exelon Patch is approved for the treatment of mild-to-moderate Alzheimers disease dementia (AD) in more than 90 countries, including more than 20 countries where it is also approved for Parkinsons disease dementia. Exelon Patch�is also indicated for the treatment of patients with severe AD in 11 countries, including the US. In Europe, the high-dose patch (15 cm2) for mild-to-moderately severe AD was launched in several markets in 2013. Exelon Patch total patient exposure is approximately 3.8 million patient years.
Ophthalmics
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
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� | � |
USD m
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� | � |
USD
|
� | � |
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|
� | � |
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|
� | � |
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� | � |
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|
� | � |
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|
� | ||||||||
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Lucentis
|
� | � | � | 588 | � | � | � | 630 | � | � | � | -7 | � | � | � | 1 | � | � | � | 2 441 | � | � | � | 2 383 | � | � | � | 2 | � | � | � | 5 | � |
|
Other
|
� | � | � | 13 | � | � | � | 14 | � | � | � | -7 | � | � | � | -4 | � | � | � | 63 | � | � | � | 61 | � | � | � | 3 | � | � | � | 5 | � |
|
Total Ophthalmics products
|
� | � | � | 601 | � | � | � | 644 | � | � | � | -7 | � | � | � | 1 | � | � | � | 2 504 | � | � | � | 2 444 | � | � | � | 2 | � | � | � | 5 | � |
Lucentis (USD 588 million, +1% cc) sales grew slightly, driven by the uptake in non-age-related macular degeneration (non-AMD) indications (such as visual impairment due to diabetic macular edema; macular edema secondary to central and branch retinal vein occlusion; and choroidal neovascularization secondary to pathologic myopia), offsetting the impact of competition in the wet AMD indication. The Lucentis pre-filled syringe was successfully launched in all key European countries, as well as Japan and Australia. Non-AMD indications contributed 43% of Lucentis sales in the fourth quarter, compared to 32% for the 2013 period. Emerging Growth Markets contributed 19% of Lucentis sales versus 18% last year. Lucentis is an anti-VEGF therapy specifically designed for the eye, minimizing systemic exposure, that has demonstrated significant efficacy with individualized dosing in its licensed indications and has a well-established safety profile supported by extensive clinical studies and real-world experience. Genentech/Roche holds the rights to Lucentis in the US.
11
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Integrated Hospital Care
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Neoral/Sandimmun
|
� | � | � | 164 | � | � | � | 195 | � | � | � | -16 | � | � | � | -9 | � | � | � | 684 | � | � | � | 750 | � | � | � | -9 | � | � | � | -6 | � |
|
Myfortic
|
� | � | � | 131 | � | � | � | 159 | � | � | � | -18 | � | � | � | -10 | � | � | � | 543 | � | � | � | 637 | � | � | � | -15 | � | � | � | -11 | � |
|
Zortress/Certican
|
� | � | � | 85 | � | � | � | 63 | � | � | � | 35 | � | � | � | 45 | � | � | � | 327 | � | � | � | 249 | � | � | � | 31 | � | � | � | 36 | � |
|
Ilaris
|
� | � | � | 54 | � | � | � | 37 | � | � | � | 46 | � | � | � | 54 | � | � | � | 199 | � | � | � | 119 | � | � | � | 67 | � | � | � | 69 | � |
|
Other
|
� | � | � | 45 | � | � | � | 43 | � | � | � | 5 | � | � | � | 9 | � | � | � | 173 | � | � | � | 169 | � | � | � | 2 | � | � | � | 4 | � |
|
Total strategic franchise products
|
� | � | � | 479 | � | � | � | 497 | � | � | � | -4 | � | � | � | 4 | � | � | � | 1 926 | � | � | � | 1 924 | � | � | � | 0 | � | � | � | 3 | � |
|
Everolimus stent drug
|
� | � | � | 62 | � | � | � | 46 | � | � | � | 35 | � | � | � | 46 | � | � | � | 205 | � | � | � | 247 | � | � | � | -17 | � | � | � | -18 | � |
|
Established medicines
|
� | � | � | 224 | � | � | � | 259 | � | � | � | -14 | � | � | � | -9 | � | � | � | 981 | � | � | � | 1 112 | � | � | � | -12 | � | � | � | -10 | � |
|
Total IHC products
|
� | � | � | 765 | � | � | � | 802 | � | � | � | -5 | � | � | � | 2 | � | � | � | 3 112 | � | � | � | 3 283 | � | � | � | -5 | � | � | � | -3 | � |
Xolair is listed in the Primary Care franchise section.
Myfortic (USD 131 million, -10% cc), a transplantation medicine, has experienced a sales decline after the expected launch of generic competition in the US in early 2014. Myfortic continued to grow in geographies without generic competition.
Zortress/Certican (USD 85 million, +45% cc), available in more than 90 countries to prevent organ rejection in adult heart and kidney transplant patients, continued to show strong growth in the fourth quarter. It is also approved in over 70 countries for liver transplant patients, in the EU, US, and many other countries worldwide. Everolimus, the active ingredient in Zortress/Certican, is marketed for other indications under the trade names Afinitor/Votubia. Everolimus is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.
Ilaris (USD 54 million, +54% cc) continued to grow as a treatment for adults and children suffering from cryopyrin-associated periodic syndrome, for which it is approved in more than 60 countries. Additionally, Ilaris is approved for the treatment of active systemic juvenile idiopathic arthritis in the US, EU and other countries an important growth driver for the product. Ilaris is also available for the symptomatic treatment of refractory acute gouty arthritis in the EU and is being developed for Hereditary Periodic Fever Syndromes.
12
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Alcon
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Net sales
|
� | � | � | 2 703 | � | � | � | 2 665 | � | � | � | 2 | � | � | � | 7 | � | � | � | 10 827 | � | � | � | 10 496 | � | � | � | 3 | � | � | � | 6 | � |
|
Operating income
|
� | � | � | 365 | � | � | � | 172 | � | � | � | 112 | � | � | � | 155 | � | � | � | 1 597 | � | � | � | 1 232 | � | � | � | 30 | � | � | � | 43 | � |
|
��As % of net sales
|
� | � | � | 13.5 | � | � | � | 6.5 | � | � | � | � | � | � | � | � | � | � | � | 14.8 | � | � | � | 11.7 | � | � | � | � | � | � | � | � | � |
|
Core operating income
|
� | � | � | 895 | � | � | � | 851 | � | � | � | 5 | � | � | � | 14 | � | � | � | 3 811 | � | � | � | 3 694 | � | � | � | 3 | � | � | � | 8 | � |
|
��As % of net sales
|
� | � | � | 33.1 | � | � | � | 32.1 | � | � | � | � | � | � | � | � | � | � | � | 35.2 | � | � | � | 35.2 | � | � | � | � | � | � | � | � | � |
Fourth quarter
Net sales
Alcon net sales were USD 2.7 billion (+2%, +7% cc) in the fourth quarter, led by robust growth in the Ophthalmic Pharmaceuticals and Surgical franchises. Emerging Growth Markets grew strongly (+7%, +17% cc), offset by weaker growth in Japan.
Ophthalmic Pharmaceuticals grew (+4%, +10% cc), driven by double-digit growth (cc) in the glaucoma franchise, Systane for dry eye, and Ilevro, a non-steroidal anti-inflammatory. Surgical performance (+1%, +7% cc) benefited from strong sales of the Centurion�phacoemulsification cataract platform, with improving growth performance in AcrySof intraocular lenses. Vision Care (0%, +4% cc) was driven by strong growth of Dailies Total1 and AirOptix Colors, offset by a decline in contact lens care solutions resulting from a continued market shift to daily disposable lenses as well as strong competitive pressures in the US.
Regionally, Emerging Growth Markets delivered strong growth (cc), led by China (+26%, +28% cc), Russia (-11%, +30% cc), and India (+12%, +12% cc). Latin America also grew strongly (+9%, +18% cc), driven by double-digit growth (cc) across franchises. North America (+6%, +7% cc) saw strong growth in Ophthalmic Pharmaceuticals and Vision Care with moderate growth in Surgical against a high prior-year comparator. Sales in Europe, the Middle East and Africa (-4%, +4% cc) improved, driven by solid Ophthalmic Pharmaceuticals performance, offset by weaker performance in Vision Care. Japan sales were weaker (-10%, +2% cc) across franchises.
Operating income
Operating income increased 112% (+155% cc) to USD 365 million, driven by strong operating performance and the ending in 2013 of integration charges related to the acquisition of Alcon. Adjustments to arrive at core operating income for the quarter amounted to USD 530 million, consisting of USD 522 million for the amortization of intangible assets, USD 10 million for restructuring costs including Group-wide rationalization of manufacturing sites, and other net income of USD 2 million. Prior-year adjustments amounted to USD 679 million due to amortization, integration costs, and restructuring charges.
Core operating income advanced 5% (+14% cc) to USD 895 million, driven by higher sales and productivity programs. Core operating income margin in constant currencies increased by 2.1 percentage points; currency had a negative impact of 1.1 percentage point,�resulting in a net increase of 1.0 percentage points to 33.1% of net sales.
Core gross margin as a percentage of net sales increased by 0.9 percentage points (cc), driven by improved product mix. Core R&D expenses decreased by 0.6 percentage points (cc) compared to prior year, driven by continued project prioritization, which offset continued investment in important clinical trials. Core M&S and core G&A expenses decreased by 0.9 percentage points (cc), despite continued investment in new product launches. Core Other Income and Expense, net increased by 0.3 percentage points (cc).
13
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Full year
Net sales
Alcon net sales grew 3% (+6% cc) to USD 10.8 billion for the full year 2014. Surgical franchise sales advanced 5% (+7% cc), driven by strong sales of equipment, led by the launch of the Centurion phacoemulsification cataract platform and Verion image-guided pre-operative diagnostic system, continued growth of the LenSx femtosecond laser platform, and growth in cataract and vitreoretinal disposables. Growth in Ophthalmic Pharmaceuticals (+3%, +5% cc) was driven by double-digit growth of Systane, Ilevro, and fixed-dose glaucoma combination products, offset by weak allergy and otic seasons in the US and Japan. Vision Care (+2%, +4% cc) benefited from launches of innovative contact lenses, including Dailies Total1 and AirOptix Colors, partially offset by declining contact lens care sales.
Regionally, Emerging Growth Markets showed strong growth, led by China (+22%, +23% cc), Russia (+6%, +27% cc), India (+8%, +13% cc), and Latin America (+8%, +17% cc). North America (+4%, +4%) grew strongly in Surgical behind a successful Centurion launch, offset by weaker growth in Ophthalmic Pharmaceuticals, primarily driven by a market decline in seasonal allergy and otic products. Europe, the Middle East and Africa (+2%, +3% cc) saw moderate Surgical and Ophthalmic Pharmaceuticals performance. Japan sales (-5%, +3% cc) grew moderately in Surgical, partially offsetting weaker growth in Ophthalmic Pharmaceuticals and Vision Care.
Operating income
Operating income increased 30% (+43% cc) to USD 1.6 billion, driven by strong operating performance as well as the ending in 2013 of integration charges related to the acquisition of Alcon. Adjustments to arrive at core operating income amounted to USD 2.2 billion, consisting of USD 2.1 billion for the amortization of intangible assets and USD 71 million for restructuring costs including Group-wide rationalization of manufacturing sites.
Core operating income increased 3% (+8% cc) to USD 3.8 billion. Core operating income margin in constant currencies increased by 0.6 percentage points; currency had a negative impact of 0.6 percentage points,�resulting in a stable core margin of 35.2% of net sales.
Core gross margin as a percentage of net sales declined by 0.7 percentage points (cc),�driven by product mix, which was impacted by the continued rollout of surgical equipment and costs relating to increasing capacity for contact lens launches. Core R&D expenses decreased 0.7 percentage points (cc) compared to prior year, driven by continued project prioritization, which offset continued investment in important clinical trials. Core M&S and core G&A expenses improved 1.0 percentage point (cc), due to continued productivity initiatives. Core Other Income and Expense, net increased by 0.4 percentage points (cc).
14
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Alcon product review
All comments below focus on fourth quarter movements.
�
Surgical
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Cataract products
|
� | � | � | 836 | � | � | � | 826 | � | � | � | 1 | � | � | � | 7 | � | � | � | 3 174 | � | � | � | 3 037 | � | � | � | 5 | � | � | � | 7 | � |
|
����������IOLs - Cataract
|
� | � | � | 319 | � | � | � | 333 | � | � | � | -4 | � | � | � | 1 | � | � | � | 1 264 | � | � | � | 1 297 | � | � | � | -3 | � | � | � | 0 | � |
|
Vitreoretinal products
|
� | � | � | 158 | � | � | � | 161 | � | � | � | -2 | � | � | � | 4 | � | � | � | 615 | � | � | � | 592 | � | � | � | 4 | � | � | � | 7 | � |
|
Refractive/Other
|
� | � | � | 72 | � | � | � | 70 | � | � | � | 3 | � | � | � | 10 | � | � | � | 284 | � | � | � | 268 | � | � | � | 6 | � | � | � | 8 | � |
|
Total
|
� | � | � | 1 066 | � | � | � | 1 057 | � | � | � | 1 | � | � | � | 7 | � | � | � | 4 073 | � | � | � | 3 897 | � | � | � | 5 | � | � | � | 7 | � |
Global Surgical sales increased 1% (+7% cc) to USD 1.1 billion in the fourth quarter, driven by strong equipment sales, including Centurion and Verion, as well as cataract and vitreoretinal disposables. While the cataract procedure market continued to expand strongly in Emerging Growth Markets, the US market experienced only moderate growth. Sales of advanced technology IOLs improved (-2%, +3% cc).
Ophthalmic Pharmaceuticals
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Glaucoma
|
� | � | � | 331 | � | � | � | 315 | � | � | � | 5 | � | � | � | 13 | � | � | � | 1 319 | � | � | � | 1 265 | � | � | � | 4 | � | � | � | 7 | � |
|
Allergy/Otic/Nasal
|
� | � | � | 178 | � | � | � | 173 | � | � | � | 3 | � | � | � | 5 | � | � | � | 887 | � | � | � | 939 | � | � | � | -6 | � | � | � | -4 | � |
|
Infection/Inflammation
|
� | � | � | 279 | � | � | � | 263 | � | � | � | 6 | � | � | � | 11 | � | � | � | 1 066 | � | � | � | 1 019 | � | � | � | 5 | � | � | � | 7 | � |
|
Dry Eye/Tears
|
� | � | � | 155 | � | � | � | 142 | � | � | � | 9 | � | � | � | 15 | � | � | � | 608 | � | � | � | 558 | � | � | � | 9 | � | � | � | 12 | � |
|
Other
|
� | � | � | 81 | � | � | � | 90 | � | � | � | -10 | � | � | � | 1 | � | � | � | 331 | � | � | � | 327 | � | � | � | 1 | � | � | � | 6 | � |
|
Total
|
� | � | � | 1 024 | � | � | � | 983 | � | � | � | 4 | � | � | � | 10 | � | � | � | 4 211 | � | � | � | 4 108 | � | � | � | 3 | � | � | � | 5 | � |
Global sales in Ophthalmic Pharmaceuticals grew 4% (+10% cc) to USD 1.0 billion in the fourth quarter. Glaucoma sales grew double-digit, driven by strong sales of fixed-dose combination products globally, including DuoTrav, Azarga and Simbrinza.
Otic and allergy sales, including Ciprodex and Pataday/Patanol products, grew moderately despite the impact of generic competitive entries to Patanase in the US. Within the Infection/Inflammation segment, sales growth was driven by Ilevro and Durezol, and other products which benefited from a low prior-year comparator. Alcon continued to experience strong growth momentum in Dry Eye, led by the Systane eye drops and ointments product family (+19%, +25% cc), from increased channel distribution and new product launches.
Vision Care
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Contact lenses
|
� | � | � | 455 | � | � | � | 436 | � | � | � | 4 | � | � | � | 10 | � | � | � | 1 897 | � | � | � | 1 793 | � | � | � | 6 | � | � | � | 7 | � |
|
Contact lens care
|
� | � | � | 158 | � | � | � | 179 | � | � | � | -12 | � | � | � | -7 | � | � | � | 646 | � | � | � | 698 | � | � | � | -7 | � | � | � | -5 | � |
|
Total
|
� | � | � | 613 | � | � | � | 615 | � | � | � | 0 | � | � | � | 4 | � | � | � | 2 543 | � | � | � | 2 491 | � | � | � | 2 | � | � | � | 4 | � |
Vision Care global product sales were stable (0%, +4% cc) at USD 613 million in the fourth quarter, benefiting from strong contact lens performance (+4%, +10% cc) with the continued rollout of Dailies Total1, AirOptix Colors, Dailies AquaComfort Plus (DACP)�Toric�and DACP Multifocal. Sales of contact lens solutions (-12%, -7% cc) declined, driven by the market shift to daily disposable lenses as well as competitive pressures in the US.
15
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Sandoz
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
|
� | � |
FY 2014
|
� | � |
FY 2013
|
� | � |
% change
|
� | ||||||||||||
| � | � | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | � |
USD m
|
� | � |
USD m
|
� | � |
USD
|
� | � |
cc
|
� | ||||||||
|
Net sales
|
� | � | � | 2 512 | � | � | � | 2 411 | � | � | � | 4 | � | � | � | 11 | � | � | � | 9 562 | � | � | � | 9 159 | � | � | � | 4 | � | � | � | 7 | � |
|
Operating income
|
� | � | � | 290 | � | � | � | 276 | � | � | � | 5 | � | � | � | 16 | � | � | � | 1 088 | � | � | � | 1 028 | � | � | � | 6 | � | � | � | 14 | � |
|
��As % of net sales
|
� | � | � | 11.5 | � | � | � | 11.4 | � | � | � | � | � | � | � | � | � | � | � | 11.4 | � | � | � | 11.2 | � | � | � | � | � | � | � | � | � |
|
Core operating income
|
� | � | � | 416 | � | � | � | 373 | � | � | � | 12 | � | � | � | 21 | � | � | � | 1 571 | � | � | � | 1 541 | � | � | � | 2 | � | � | � | 7 | � |
|
��As % of net sales
|
� | � | � | 16.6 | � | � | � | 15.5 | � | � | � | � | � | � | � | � | � | � | � | 16.4 | � | � | � | 16.8 | � | � | � | � | � | � | � | � | � |
Fourth quarter
Net sales
Sandoz net sales increased 4% (+11% cc) to USD 2.5 billion in the fourth quarter, as volume growth of 20 percentage points more than compensated for 9 percentage points of price erosion.
US sales of retail generics and biosimilars delivered strong growth (+24% cc), driven by recent successful launches, partly offset by higher price erosion. Germany grew (+5% cc) in a declining market, while Western Europe (excluding Germany) grew 4% (cc). Japan continued to show double-digit growth (+14% cc). In emerging markets, Asia (excluding Japan, +18% cc) and Latin America (+17% cc) grew strongly, while Central and Eastern Europe increased sales by 6% (cc) in the quarter.
Sandoz continued to strengthen its leading global position in biosimilars (USD 132 million, +18% cc), with double-digit sales growth driven by strong momentum in its three in-market products Omnitrope (human growth hormone), Binocrit (epoetin alfa), and Zarzio (filgrastim) each of which is the leading biosimilar in its respective market segment.
Operating income
Sandoz operating income increased 5% (+16% cc) to USD 290 million. Adjustments to arrive at core operating income for the quarter amounted to a net expense of USD 126 million, including amortization of intangible assets of USD 96 million and impairment charges of USD 18 million.
Core operating income increased 12% (+21% cc) to USD 416 million. Core operating income margin in constant currencies increased 1.4 percentage points; currency had a negative impact of 0.3 percentage points, resulting in a net increase of 1.1 percentage points to 16.6% of net sales.
Core gross margin as a percentage of net sales increased by 0.9 percentage points (cc), driven by product mix and ongoing productivity improvements, partially offset by continued price erosion. Core R&D expenses decreased by 0.1 percentage points (cc) as higher sales offset additional investments in biosimilar clinical trials. Core M&S and core G&A expenses improved by 1.1 percentage points (cc), despite ongoing investments into biosimilars. Core Other Income and Expense, net decreased the margin by 0.7 percentage points (cc), largely due to favorable exceptional items in the prior-year quarter.
Full year
Net sales
Net sales increased by 4% (+7% cc) to USD 9.6 billion, as volume growth of 15 percentage points more than offset 8 percentage points of price erosion. Performance was driven by strong retail generics and biosimilars sales growth (including the Diovan monotherapy authorized generic launch) in Asia (excluding Japan) (+15% cc), the US (+14% cc), Latin America (+10% cc) and Canada
(+9% cc). Central and Eastern Europe (+5% cc) and Western Europe (excluding Germany) (+4% cc) showed solid growth, while German sales were stable (0% cc). Biosimilars grew 23% (cc) to reach USD 514 million globally in 2014.
Operating income
Operating income increased by 6% (+14% cc) to USD 1.1 billion, benefiting from strong operating performance and unrepeated prior-year legal settlements. Adjustments to arrive at core operating income amounted to a net expense of USD 483 million, mainly due to USD 400 million for the amortization of intangible assets and USD 47 million of impairment charges.
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Core operating income was up 2% (+7% cc) to USD 1.6 billion. Core operating income margin in constant currencies increased by 0.1 percentage points, despite high price erosion; currency had a negative impact of 0.5 percentage points, resulting in a net decrease of 0.4 percentage points to 16.4% of net sales.
Core gross margin as a percentage of net sales decreased 0.2 percentage points (cc), as high price erosion was only partially compensated by favorable sales mix and productivity programs. Core R&D expenses improved by 0.1 percentage points (cc), and Core M&S and core G&A expenses improved by 0.3 percentage points (cc), driving operating leverage as sales continued to grow. Core Other Income and Expense, net decreased the margin by 0.1 percentage points (cc).
Sandoz franchises
Sandoz continued to strengthen its global leadership position in differentiated generics,1 including medicines that are difficult to develop and manufacture. Differentiated generics accounted for 45% of Sandoz sales in 2014.
| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
% change
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FY 2014
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FY 2013
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|
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Retail Generics
|
� | � | � | 2 065 | � | � | � | 2 016 | � | � | � | 2 | � | � | � | 10 | � | � | � | 7 933 | � | � | � | 7 663 | � | � | � | 4 | � | � | � | 6 | � |
|
Biopharmaceuticals & Oncology Injectables
|
� | � | � | 305 | � | � | � | 246 | � | � | � | 24 | � | � | � | 32 | � | � | � | 1 094 | � | � | � | 888 | � | � | � | 23 | � | � | � | 25 | � |
|
Anti-Infectives
|
� | � | � | 142 | � | � | � | 149 | � | � | � | -5 | � | � | � | 3 | � | � | � | 535 | � | � | � | 608 | � | � | � | -12 | � | � | � | -12 | � |
|
Total
|
� | � | � | 2 512 | � | � | � | 2 411 | � | � | � | 4 | � | � | � | 11 | � | � | � | 9 562 | � | � | � | 9 159 | � | � | � | 4 | � | � | � | 7 | � |
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1 Sandoz differentiated products are comprised of biosimilars and generic injectables, ophthalmics, dermatologics, and respiratory, as well as difficult-to-make oral solids (such as tacrolimus).
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DISCONTINUING OPERATIONS1
Vaccines2
| � | � | � | � | � | � |
excl. Diagnostics3
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Reported
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| � | � | � | � | Q4 2014 | � | � | � | Q4 2013 | � | � |
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FY 2014
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FY 2013
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FY 2013
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Net sales
|
� | � | � | 494 | � | � | � | 503 | � | � | � | -2 | � | � | � | 4 | � | � | � | 655 | � | � | � | 1 537 | � | � | � | 1 422 | � | � | � | 8 | � | � | � | 10 | � | � | � | 1 987 | � |
|
Operating loss
|
� | � | � | -1 084 | � | � | � | -96 | � | � |
nm
|
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nm
|
� | � | � | -1 | � | � | � | -552 | � | � | � | -477 | � | � | � | -16 | � | � | � | -15 | � | � | � | -238 | � | ||
|
��As % of net sales
|
� | � | � | -219.4 | � | � | � | -19.1 | � | � | � | � | � | � | � | � | � | � | � | -0.2 | � | � | � | -35.9 | � | � | � | -33.5 | � | � | � | � | � | � | � | � | � | � | � | -12.0 | � |
|
Core operating loss
|
� | � | � | -6 | � | � | � | -52 | � | � |
nm
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|
� | � | � | � | � | � | � | -290 | � | � | � | -302 | � | � | � | 4 | � | � | � | 5 | � | � | � | � | � | ||
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��As % of net sales
|
� | � | � | -1.2 | � | � | � | -10.3 | � | � | � | � | � | � | � | � | � | � | � | � | � | � | � | -18.9 | � | � | � | -21.2 | � | � | � | � | � | � | � | � | � | � | � | � | � |
All periods exclude certain intellectual property rights and related other revenues which will be retained by Novartis and are now reported under Corporate activities, with 2013 results restated for this impact. All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date.
Fourth quarter
Net sales
Net sales were USD 494 million (-2%, +4% cc) for the fourth quarter compared to USD 503 million in the prior-year period. Solid demand across the product portfolio was driven by the Meningitis franchise, which benefited from sales of recently launched Bexsero. This was offset by an earlier US influenza season and lower sales to the US Department of Health and Human Services.
Operating loss
Operating loss was USD 1.1 billion for the fourth quarter compared to a loss of USD 96 million in the prior-year period, driven by an exceptional pre-tax impairment charge of USD 1.1 billion related to the pending divestment to CSL of the influenza vaccines business. Due to the cessation of depreciation and amortization charges from the portfolio transformation announcement date, the prior year contained approximately USD 73 million of higher depreciation and amortization charges in the quarter compared to the current year, comprised of USD 35 million for depreciation and USD 38 million for amortization.
Adjustments to arrive at core operating loss amounted to USD 1.1 billion compared to adjustments of USD 44 million in the prior-year period, driven by the USD 1.1 billion impairment charge for the influenza vaccines business.
Core operating loss for the fourth quarter was USD 6 million compared to a loss of USD 52 million for the prior-year period. The improvement in core operating loss was mainly due to a higher margin product mix and the cessation of depreciation of USD 35 million, partially offset by increased operating costs of the Holly Springs facility in the US and enrollment in two large Phase III quadrivalent influenza vaccine studies.
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1 Despite the IFRS required presentation of discontinuing versus continuing operations, until the transactions with GSK and CSL are closed, Novartis remains fully committed to all Group activities.
2�All periods exclude certain intellectual property rights and related other revenues which will be retained by Novartis and are now reported under Corporate activities, with 2013 reported results being restated for this impact.
3 All comparisons to prior year are based on 2013 data excluding the blood transfusion diagnostics unit. See page 85.
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Full year
Net sales
Net sales increased 8% (+10% cc) to USD 1.5 billion for the year compared to USD 1.4 billion in 2013, driven by solid demand across the product portfolio, particularly in the Meningitis franchise (USD 454 million, +41% cc) due to Menveo, Menjugate and the recently launched Bexsero. In the Travel and Pediatric franchise, sales grew 11% (cc) to USD 607 million, driven by tick-borne encephalitis vaccine and Ixiaro sales. Influenza vaccine sales amounted to USD 476 million (-8% cc) as lower pre-pandemic sales, driven by the US Department of Health and Human Services, were partially offset by strong seasonal influenza sales.
Operating loss
Operating loss was USD 552 million for 2014 compared to a loss of USD 477 million in 2013. The increase in operating loss was driven by the exceptional USD 1.1 billion impairment charge for the influenza vaccines business, mostly offset by the USD 876 million exceptional gain from the divestment of the blood transfusion diagnostics unit to Grifols S.A. Due to the cessation of depreciation and amortization charges from the portfolio transformation announcement date, the prior year contained approximately USD 204 million of higher depreciation and amortization charges compared to the current year, comprised of USD 95 million for depreciation and USD 109 million for amortization.
Adjustments to arrive at core operating loss amounted to USD 262 million, driven by the USD 1.1 billion impairment of the influenza vaccines business, mostly offset by the USD 876 million exceptional divestment gain. Prior-year adjustments amounted to USD 175 million, mainly due to amortization.
Core operating loss was USD 290 million in 2014 compared to a loss of USD 302 million in the prior year. The improvement in core operating loss was due to increased sales and the cessation of depreciation of USD 95 million, partially offset by operating costs of the Holly Springs facility and enrollment in two large Phase III quadrivalent influenza vaccine studies.
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Consumer Health
| � | � | � | � | Q4 20141 | � | � | � | Q4 2013 | � | � |
% change
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FY 2013
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Net sales
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� | � | � | 1 064 | � | � | � | 1 034 | � | � | � | 3 | � | � | � | 11 | � | � | � | 4 279 | � | � | � | 4 064 | � | � | � | 5 | � | � | � | 8 | � |
|
Operating income
|
� | � | � | 172 | � | � | � | 48 | � | � | � | 258 | � | � | � | 292 | � | � | � | 470 | � | � | � | 178 | � | � | � | 164 | � | � | � | 196 | � |
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��As % of net sales
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� | � | � | 16.2 | � | � | � | 4.6 | � | � | � | � | � | � | � | � | � | � | � | 11.0 | � | � | � | 4.4 | � | � | � | � | � | � | � | � | � |
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Core operating income
|
� | � | � | 115 | � | � | � | 60 | � | � | � | 92 | � | � | � | 122 | � | � | � | 452 | � | � | � | 298 | � | � | � | 52 | � | � | � | 72 | � |
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��As % of net sales
|
� | � | � | 10.8 | � | � | � | 5.8 | � | � | � | � | � | � | � | � | � | � | � | 10.6 | � | � | � | 7.3 | � | � | � | � | � | � | � | � | � |
Fourth quarter
Net sales
Consumer Health, which comprises OTC and Animal Health, saw net sales increase 3% (+11% cc) to USD 1.1 billion in the fourth quarter, driven by strong OTC momentum.
OTC delivered double-digit sales growth (+14% cc) in the quarter. The Cough Cold portfolio grew double-digit (cc), mainly due to the recent US re-launch of Theraflu�and Otrivin in Russia. Voltaren (+20% cc), the seventh-largest global over-the-counter brand, continued to deliver broad-based, double-digit growth. North America delivered robust double-digit growth driven by the US re-launch of Theraflu and the Excedrin portfolio, including the recently launched Mild Headache. Emerging Growth Markets continued to grow double-digit (cc), led by Russia, China and Brazil.
Animal Health delivered single-digit sales growth (+3% cc) in the quarter, with North America showing a slight decline against a strong prior-year comparator. Sentinel, a companion animal parasiticide product, which was re-launched in North America last year, continued to gain market share. In Europe, the business declined slightly (cc) from the previous-year quarter, while both Asia Pacific and Latin America delivered strong, double-digit sales growth (cc). Key products such as Onsior in the companion animal category and�Denagard and Agita�in the farm animal category grew double-digit in the quarter. Emerging Growth Markets were led by double-digit growth (cc) in Russia, Thailand, Vietnam, Brazil and China.
Operating income
Operating income amounted to USD 172 million compared to USD 48 million in the prior-year quarter, driven by higher gross margin from sales, strong operating leverage and income from a divestment in the US. The cessation of depreciation and amortization charges from the portfolio transformation announcement date had a positive impact of USD 28 million for the quarter, comprised of USD 13 million for depreciation and USD 15 million for amortization. Adjustments to arrive at core operating income for the quarter amounted to USD 57 million, due to income from a divestment partially offset by integration costs and restructuring expenses. Prior-year adjustments amounted to USD 12 million, consisting mainly of the amortization of intangible assets.
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Core operating income increased 92% (+122% cc) to USD 115 million. Core operating income margin in constant currencies increased by 5.9 percentage points; currency had a negative impact of 0.9 percentage points, resulting in a net increase of 5.0 percentage points to 10.8% of net sales.
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Core gross margin as a percentage of net sales increased by 0.3 percentage points (cc), largely due to the cessation of depreciation charges. Core R&D expenses decreased by 1.0 percentage point (cc). Core M&S expenses decreased by 4.7 percentage points (cc) due to operating leverage as sales continued to grow and due to good cost management. Core G&A expenses decreased by 1.5 percentage points (cc). Core Other Income and Expense, net had a negative margin effect of 1.6 percentage points (cc).
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1 2014 results exclude depreciation and amortization related to discontinuing operations from the portfolio transformation announcement date.
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Full year
On January 1, 2015, Novartis completed the divestment of its Animal Health division to Eli Lilly and Company (Lilly) for approximately USD 5.4 billion. This will realize a pre-tax gain of approximately USD 4.6 billion.
Net sales
Consumer Health net sales increased 5% (+8% cc) to USD 4.3 billion in 2014, driven by strong performance of key global brands and product re-launches in OTC and Animal Health.
OTC sales reached USD 3.1 billion, up 9% (cc) over the previous year, driven by strong growth of all strategic brands, including Theraflu, Voltaren, Excedrin and Otrivin.Voltaren (+22% cc)�delivered strong double-digit sales growth following successful launches of the 12-hour formulation and continued solid commercial execution in key markets. Theraflu delivered double-digit growth (cc) supported by the US re-launch, despite the weaker cough and cold season early in 2014. North America achieved double-digit growth due to a strong performance of Voltaren in Canada, as well as the US re-launch of Theraflu. Europe grew significantly ahead of the market, driven by Germany and Southern Europe. Emerging Growth Markets delivered double-digit growth (cc), led by China and Brazil, with robust growth in Russia.
Animal Health sales reached USD 1.2 billion, up 5% (cc) over the previous year, with high single-digit growth in North America, driven by continued growth momentum in Sentinel since its re-launch in April 2013. Europe grew mid-single digit (cc), led by strong performance of Milbemax, the number one de-wormer for cats and dogs. Asia and Latin America also delivered single-digit growth (cc) over the previous year. Key products such as Deramaxx and Onsior in the companion animal category, as well as Clik, Zolvix and Agita in the farm animal category, delivered strong double-digit growth (cc) compared to 2013. Growth in Emerging Growth Markets was led by Russia, China, Thailand and Brazil.
Operating income
Operating income amounted to USD 470 million compared to USD 178 million in the prior-year period, driven by higher gross margin from incremental sales and lower Lincoln plant remediation and restructuring expenses. The impact of cessation of depreciation and amortization charges from the portfolio transformation announcement date had a positive impact of USD 73 million in the year, comprised of USD 34 million for depreciation and USD 39 million for amortization. Adjustments to arrive at core operating income amounted to USD 18 million, consisting mainly of income from a divestment in the US, amortization of intangible assets, integration costs and restructuring expenses. Prior-year adjustments amounted to USD 120 million, consisting mainly of Lincoln-related impairments and restructuring expenses as well as amortization of intangibles.
Core operating income increased 52% (+72% cc) to USD 452 million. Core operating income margin in constant currencies increased by 4.3 percentage points. Currency had a negative impact of 1.0 percentage point, largely driven by erosion of emerging markets currencies, resulting in a net increase of 3.3 percentage points to 10.6% of net sales.
Product mix, lower current-year costs at the Lincoln manufacturing facility and the cessation of depreciation charges generated a core gross margin increase of 1.8 percentage points (cc). Core R&D expenses decreased by 0.4 percentage points (cc). Core M&S expenses decreased by 3.1 percentage points (cc) driving operating leverage as sales continued to grow. Core G&A expenses decreased by 0.6 percentage points (cc). Core Other Income and Expense, net had a negative margin effect of 1.6 percentage points (cc), largely driven by income from divestments of smaller non-core brands in the prior year.
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Consolidated financial statements reflecting the portfolio transformation
Following the announcement of the transactions with GlaxoSmithKline plc (GSK) and Eli Lilly and Company (Lilly) on April 22, 2014 (and the subsequent transaction with CSL Limited), in order to comply with International Financial Reporting Standards (IFRS), Novartis has separated the Groups reported financial data for the current and prior years into discontinuing and continuing operations.
Discontinuing operations include the Animal Health Division, the OTC Division, and all of the Vaccines Division except for certain intellectual property rights and related other revenues which will be retained by Novartis and are now reported under Corporate activities. Also included under Corporate are certain transaction-related expenses.
Discontinuing operations also include the gain on the divestment of the blood transfusion diagnostics unit, completed on January 9, 2014, and related prior-year results for this activity. Due to this divestment, the 2013 Novartis Group and Vaccines divisional data contained within this release excludes the results of the blood transfusion diagnostics unit, to help illustrate performance on a comparable basis.
As required by IFRS, 2014 results exclude from the announcement date any further depreciation and amortization related to discontinuing operations.
The transaction with Lilly closed on January 1, 2015 with the divestment of Animal Health. Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with CSL Limited (CSL) to be completed in the second half of 2015, subject to customary closing conditions including regulatory approvals. Despite the IFRS required presentation of discontinuing versus continuing operations, until the GSK and CSL transactions are closed, Novartis remains fully committed to all Group activities.
Continuing operations comprise all other activities of the Novartis Group, including the Pharmaceuticals, Alcon and Sandoz Divisions and the retained Corporate activities.
Continuing operations do not yet include the results from oncology net assets to be acquired from GSK on closing of the transaction or the results from the 36.5% interest in the GSK/Novartis consumer healthcare joint venture that will be created at the same time.
Details of the split of the Groups consolidated income statement into discontinuing and continuing operations for all quarters of 2013 and for the first quarter of 2014 can be found on our website at http://www.novartis.com/downloads/investors/financial-results/quarterly-results/q2-2014-required-changes.pdf.
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CASH FLOW AND GROUP BALANCE SHEET
Cash flow
Fourth quarter
Cash flow from Group total operating activities in the fourth quarter amounted to USD 5.2 billion compared to USD 4.5 billion in the prior-year period. The increase was due to higher hedging gains and lower net working capital as well as lower payments out of provisions. Of the Group total, continuing operations contributed USD 4.7 billion compared to USD 4.0 billion in the prior-year period.
The cash outflows for Group total investing activities in the fourth quarter amounted to USD 0.9 billion compared to USD 2.7 billion in the prior-year period. The investing cash outflows from continuing operations amounted to USD 0.8 billion, compared to an outflow of USD 2.6 billion in 2013. In the current year, there was an inflow from the final installment on the sale of the investment in LTS Lohmann Therapie-Systeme AG of USD 0.3 billion, while the prior year included an outflow for investments in marketable securities of USD 1.5 billion. Investments in property, plant and equipment of USD 0.8 billion were lower by USD 0.2 billion and investments in intangible, financial and other non-current assets remained consistent with the prior-year level. The current year outflow for the acquisition of WaveTech of USD 0.4 billion was offset by the inflows from the sale of property, plant and equipment, intangible, financial and other non-current assets.
The Group total cash flow used in financing activities in the fourth quarter amounted to USD 0.7 billion compared to USD 1.5 billion in the prior-year period. The current year includes a cash outflow for treasury share transactions of USD 1.9 billion which was partially offset by the net proceeds of USD 1.2 billion from the issue of new EUR bonds and repayment of other financial debt. The prior-year period included an outflow for treasury shares of USD 0.7 billion and for the net repayment of current debt of USD 0.8 billion.
Free cash flow for the fourth quarter was USD 4.4 billion, an increase of 41% or USD 1.3 billion compared to the year-ago period. This was primarily due to higher cash flows from operating activities which mainly benefited from higher hedging gains and lower net working capital. Also contributing were higher proceeds from Novartis Venture Fund divestments and lower investment in property, plant and equipment.
Full year
Cash flow from Group total operating activities increased to USD 13.9 billion from USD 13.2 billion in 2013, an increase of USD 0.7 billion. This was primarily due to higher operating income adjusted for non-cash items, despite negative currency effects, and increased hedging gains, partially offset by payments for legal settlements and restructuring.
The Groups total investing activities resulted in an inflow of USD 0.9 billion compared to an outflow of USD 3.4 billion in 2013 mainly on account of an inflow from the net proceeds of USD 1.1 billion related to the divestment of the blood transfusion diagnostics unit to Grifols S.A.. In 2014, there were also proceeds from the sale of investments in associated companies included, in particular LTS Lohmann Therapie-Systeme AG and Idenix Pharmaceuticals, Inc. of USD 0.6 billion and USD 0.8 billion respectively and of USD 1.9 billion from the net sale of other marketable securities including maturing long-term deposits. These inflows were offset by outflows of USD 2.6 billion for property, plant and equipment and a net amount of USD 0.7 billion for acquisition of businesses mainly the acquisition of WaveTec (USD 0.4 billion) and other non-current assets, primarily intangible assets. The prior year outflow for investing activities of USD 3.4 billion was primarily related to investments in property, plant and equipment of USD 2.9 billion and a net outflow of USD 0.5 billion for the acquisition of businesses and other non-current assets, mainly intangible assets.
The Group total cash flows used in financing activities amounted to USD 8.1 billion compared to USD 8.8 billion in 2013. The current year includes the dividend payment of USD 6.8 billion, net treasury share transactions of USD 4.5 billion and a net increase in financial debt of USD 3.3 billion, principally due to the issuance of four bonds totaling USD 5.5 billion reduced by the repayment at maturity of a bond of USD 2.0 billion. In 2013, the dividend payment amounted to USD 6.1 billion, net treasury share transactions were USD 1.2 billion and financial debt decreased by a net amount of USD 1.3 billion.
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Free cash flow for the year was USD 10.8 billion, an increase of 12% or USD 1.2 billion compared to prior year. This was primarily due to higher cash flows from operating activities, which mainly benefited from higher operating income adjusted for non-cash items, despite negative currency effects and, increased hedging gains partially offset by higher investments in intangible assets.
Balance sheet
Assets
There has been a significant reclassification of assets as a result of the portfolio transformation announced on April 22, 2014. Total non-current assets of USD 87.8 billion at December 31, 2014 decreased by USD 7.9 billion as compared to 2013, mainly as a result of the assets transferred to discontinuing operations. Total current assets increased by USD 7.0 billion to USD 37.6 billion at December 31, 2014, also mainly due to the reclassification mentioned above and an increase in cash and marketable securities.
Excluding the effect of the reclassifications, total non-current assets decreased by USD 3.7 billion to USD 92.1 billion at December 31, 2014. The reduction of USD 3.3 billion in intangible assets and goodwill was driven by the amortization and impairment charges of USD 3.5 billion.�Property, plant and equipment reduced by USD 0.8 billion.�This was partially offset by an increase in financial and other non-current assets of USD 0.4 billion. Excluding the effect of reclassifications,��trade receivables and other current assets decreased by USD 0.5 billion respectively while inventory remained stable at USD 7.3 billion.
The Group has an equivalent of approximately USD 0.4 billion of cash in Venezuela in local currency, which is only slowly being approved for remittance outside of the country. As a result, the Group is exposed to a potential devaluation loss in the income statement on its total intercompany balances with its subsidiaries in Venezuela, which at December 31, 2014 amounted to USD 0.4 billion. The Group continues to use for the consolidation of the financial statements of its Venezuelan subsidiaries the official exchange rate of VEF 6.3/USD, which is applied for health and food imports as published by the Centro Nacional de Comercio Exterior (CENCOEX, formerly CADIVI).
Financial debt
Total financial debt, including derivatives, amounted to USD 20.4 billion at December 31, 2014 compared to USD 18.0 billion at December 31, 2013. Long-term debt increased by USD 2.6 billion to USD 13.8 billion at December 31, 2014, due to the issuance of four bonds and additional long-term debt totaling USD 5.5 billion and a reclassification to short-term debt of bonds which mature within 12 months totaling USD 2.9 billion. Short-term borrowings amounted to USD 6.6 billion at December 31, 2014 compared to USD 6.8 billion at December 31, 2013.
Liabilities
At December 31, 2014, trade payables of USD 5.4 billion, other current liabilities of USD 12.5 billion and other non-current liabilities of USD 13.8 billion decreased compared to prior year, mainly due to the reclassification to discontinuing operations. On a comparable basis, trade payables of the Group decreased slightly by USD 0.1 billion compared to the prior year, while other current liabilities and other non-current liabilities increased by USD 0.2 billion and USD 0.3 billion respectively.
Group equity
The Groups equity decreased by USD 3.6 billion to USD 70.8 billion at December 31, 2014 mainly on account of currency translation differences of USD 2.2 billion. Net actuarial losses and the repurchase commitment under the share buy-back trading plan further reduced equity by USD 0.8 billion and USD 0.7 billion respectively, while positive impact of the net income of USD 10.3 billion and from share based compensation of USD 1.1 billion were compensated by the dividend payments for 2013 of USD 6.8 billion and net purchases of treasury shares for USD 4.5 billion.
Net debt and debt/equity ratio
The Groups liquidity amounted to USD 13.9 billion at December 31, 2014, compared to USD 9.2 billion at December 31, 2013, and net debt decreased over the same period by USD 2.3 billion to USD 6.5 billion. The debt/equity ratio increased to 0.29:1 at December 31, 2014 compared to 0.24:1 at December 31, 2013.
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INNOVATION REVIEW
Benefiting from our continued focus on innovation, Novartis has one of the industrys most competitive pipelines with more than 200 projects in clinical development, including 135 in Pharmaceuticals.
Key developments from the fourth quarter of 2014 include:
New approvals and positive opinions
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In January 2015, the European Commission (EC) and FDA approved Cosentyx (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. The EC approval followed a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), marking the first time that the CHMP has recommended a biologic treatment as first-line systemic, reinforcing the favorable safety profile of Cosentyx. The US decision followed a unanimous recommendation from the FDAs Dermatologic and Ophthalmic Drugs Advisory Committee.
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The Japanese Ministry of Health, Labour and Welfare (MHLW) approved Cosentyx for the treatment of both psoriasis vulgaris and psoriatic arthritis in adults who are not adequately responding to systemic therapies (except for biologics). This decision marked the first country approval for Cosentyx in the world and made it the first interleukin-17A (IL-17A) inhibitor to receive regulatory approval in either of these indications in Japan.
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The EC approved Signifor (pasireotide) as a new long-acting release formulation for once-monthly intramuscular injection to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue. The FDA also approved pasireotide, as Signifor LAR, for injectable suspension as a treatment for patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
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The EC approved a new indication for Alcons Travatan�eye drops solution (40�g/mL travoprost) to decrease elevated intraocular pressure in pediatric patients with ocular hypertension or pediatric glaucoma.
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The FDA Ophthalmic Devices Advisory Committee gave a positive recommendation for Alcons AcrySof IQ ReSTOR 3.0D Toric Intraocular Lens.
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In the EU, Alcon received approval for an expanded range of power parameters for Dailies Total1 contact lenses.
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Alcon received FDA approval of Xtoro (finafloxacin otic suspension) 0.3% for the treatment of acute otitis externa, commonly known as swimmers ear.
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In January 2015, the FDAs Oncology Drugs Advisory Committee (ODAC) voted unanimously to recommend approval of Sandoz biosimilar filgrastim in all indications currently on the reference products (Neupogen�) label. The FDA accepted Sandoz biosimilar application for filgrastim in July, marking the industrys first filing under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009.
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In January 2015, FDA granted an accelerated approval of Bexsero (Meningococcal Group B Vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age.
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Regulatory submissions and filings
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The last components of the LCZ696 new drug application (NDA) for heart failure with reduced ejection fraction (HFrEF) were submitted to the FDA, starting the formal review clock. A marketing authorization application was also submitted in the EU, with initiation of the CHMP accelerated assessment in January 2015. The CHMPs decision to grant accelerated assessment to LCZ696 shortened the review process by 60 days.
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Regulatory applications were submitted to the FDA for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in chronic obstructive pulmonary disease (COPD).
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The FDA extended its review period by up to three months for the NDA of LBH589 (panobinostat) in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma.�The extension follows an FDA ODAC meeting in November. Regulatory filings for LBH589 were submitted in the EU in May 2014 and in Japan (where it has orphan drug status) in September 2014.
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Regulatory applications for a new film-coated tablet formulation of deferasirox (Exjade FCT) were submitted in Canada and Colombia.
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Results from ongoing trials and other highlights
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In the CLEAR study, Cosentyx�(secukinumab) demonstrated superiority to Stelara� (ustekinumab) and met its primary endpoint of achieving Psoriasis Area and Severity Index (PASI) 90, which represents clear or almost clear skin at Week 16. The study also met the secondary endpoint of achieving PASI 75 at Week 4. Safety results were consistent with previously reported Phase III clinical trials for Cosentyx.
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Novartis presented results from the MEASURE 1 and MEASURE 2 pivotal Phase III studies for Cosentyx in ankylosing spondylitis (AS) at the American College of Rheumatology Congress. In these studies, Cosentyx met the primary endpoint, demonstrating rapid and statistically significant improvements versus placebo in the signs and symptoms of AS.
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At the same meeting, Novartis shared first results from the pivotal Phase III FUTURE 1 and FUTURE 2 studies, which demonstrated rapid and significant clinical improvements with Cosentyx versus placebo in improving the signs and symptoms of psoriatic arthritis.
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Following the results of the NURTURE 1 study of AIN457 (secukinumab) in rheumatoid arthritis (RA), in which the study met its primary endpoint but did not reach statistical significance for several pre-specified endpoints, Novartis will discontinue the development program of AIN457 in RA.
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New analyses confirmed LCZ696 could change the course of heart failure for patients, with lower incidence of sudden deaths, emergency room visits, hospitalizations, worsening symptoms and need for more intense treatment versus enalapril in HFrEF patients.
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In December 2014, Novartis announced positive top-line results from the pivotal Phase III clinical trial programs for QVA149 and NVA237 to support NDAs with the FDA for the long-term maintenance treatment of COPD. The results from the EXPEDITION and GEM clinical trial programs met their primary and secondary endpoints.
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Data on investigational chimeric antigen receptor (CAR) therapy CTL019 were presented at the American Society of Hematology (ASH) annual meeting. In one long-term pediatric study, results showed that 36 of 39 patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL), or 92%, experienced complete remissions with CTL019. Sustained remissions were achieved up to one year or more with six-month event-free survival of 70% and overall survival of 75%, in most cases without further therapy. All pediatric patients who responded to the therapy experienced a cytokine release syndrome, while their reprogrammed T-cells were expanding. Additional abstracts presented at ASH evaluated the efficacy and safety of CTL019 in the treatment of B-cell cancers including r/r ALL, chronic lymphocytic leukemia and B-cell non-Hodgkin lymphoma. These trials continue to increase the understanding of the science and potential benefit/risk profile of CTL019.
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An update involving more than 1,000 patients from the JUMP study the largest clinical trial of myelofibrosis patients treated with Jakavi (ruxolitinib) to date supported the safety profile and efficacy benefit of Jakavi, as measured in primary and secondary endpoints, respectively. The findings, which were presented at ASH, showed 69% of patients treated with Jakavi achieved more than 50% reduction in spleen length from baseline and had a clinically
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meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis.
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Six-year results from the randomized Phase III ENESTnd study presented at ASH continue to demonstrate the superiority of Tasigna (nilotinib) compared to Gleevec/Glivec (imatinib) at achieving higher rates of early, deep and sustained molecular responses in newly-diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). These data confirmed the favorable risk/benefit profile of Tasigna vs. Gleevec/Glivec in this patient population.
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In December 2014, Alcon initiated a Phase III program to evaluate the efficacy and safety of RTH258 (formerly known as ESBA1008) versus aflibercept in patients with wet age-related macular degeneration (AMD). This program follows positive Phase II study results comparing the safety and efficacy of RTH258 to ranibizumab and aflibercept, respectively.
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Results from the Phase III BOLERO-1 trial evaluating Afinitor (everolimus) in combination with trastuzumab and paclitaxel as a first-line treatment in women with human epidermal growth factor receptor-2 positive (HER2+) advanced breast cancer were presented at the San Antonio Breast Cancer Symposium. The trial did not meet the threshold of statistical significance for both primary objectives of the study: progression-free survival (PFS) among�patients with HER2+ advanced breast cancer, or the sub-population of women with hormone-receptor negative (HR-) HER2+ advanced breast cancer. However, the PFS benefit of 7 months shown in the HR-/HER2+ population suggests the potential role of PI3K/AKT/mTOR pathway inhibition in HER2+ advanced breast cancer. Novartis is not planning any regulatory submissions for everolimus in HER2+ advanced breast cancer.
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The Phase III INFORMS study of fingolimod in primary progressive multiple sclerosis (PPMS) did not meet the primary endpoint. The trial did not show a significant difference between fingolimod and placebo on a combination of disability measures. The safety results were consistent with the well-characterized safety profile of fingolimod in relapsing MS. There are currently no approved treatments that have been shown to change the course of PPMS.
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In January 2015, Novartis announced it signed collaboration and licensing agreements with Intellia Therapeutics for the discovery and development of new medicines using CRISPR genome editing technology (including engineered chimeric antigen receptor T-cells and hematopoietic stem cells) and Caribou Biosciences for the development of drug discovery tools.
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In January 2015, Novartis established a joint investment company with Qualcomm Ventures of up to USD 100 million to support early stage companies with technologies, products or services that go beyond the pill to benefit physicians and patients. Novartis aims to leverage digital technologies to provide integrated solutions and optimize the value of innovative medicines.
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Selected approvals: US, EU and Japan
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Product
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Active ingredient
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Indication
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Approval date
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Cosentyx (AIN457)
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secukinumab
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Psoriasis
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Japan December 2014
EU January 2015
US January 2015
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Cosentyx (AIN457)
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secukinumab
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Psoriatic arthritis
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Japan December 2014
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Signifor LAR
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pasireotide
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Acromegaly
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US December 2014
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Signifor
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pasireotide
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Acromegaly
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EU November 2014
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Selected projects awaiting regulatory decisions
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Completed submissions
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Product
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Indication
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US
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EU
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Japan
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News update
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Cosentyx (AIN457)
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Psoriasis
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Q4 2013
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Q4 2013
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Q4 2013
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- CHMP opinion in Nov. 2014 for first-line treatment of moderate-to-severe psoriasis patients
- Unanimous recommendation of approval from FDA Advisory Committee in Oct. 2014
- Swissmedic decision expected Q1 2015 following submission in Nov. 2013
- Total country submissions to date: 15
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Exjade FCT
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Iron overload
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Q2 2014
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Jakavi
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Polycythemia
vera
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Approved1
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Q2 2014
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Q3 2014
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LBH589
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Multiple myeloma
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Q1 2014
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Q2 2014
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Q3 2014
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- Global filings underway
- FDA extended review period by up to three months for LBH589 NDA
- Orphan drug designation in Japan
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LCZ696
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Chronic heart failure with reduced ejection fraction
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Q4 2014
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Q4 2014
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- Final components submitted to US FDA in Dec. 2014
- MAA submitted in EU, initiation of accelerated assessment
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LDE225 (sonidegib)
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Advanced basal cell carcinoma
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Q3 2014
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Q2 2014
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- US application submitted Sep. 2014
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Seebri Breezhaler (NVA237)
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Chronic obstructive pulmonary disease (COPD)
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Q4 2014
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Approved
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Approved
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- US application submitted Dec. 2014
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Ultibro Breezhaler (QVA149)
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COPD
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Q4 2014
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Approved
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Approved
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- US application submitted Dec. 2014
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Zykadia
(LDK378)
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ALK+ non-small cell lung cancer
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Approved
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Q1 2014
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1 Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the US. Ruxolitinib is marketed in the US by Incyte under the brand name Jakafi�.
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Selected Pharmaceuticals pipeline projects
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Project/ Compound
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Potential indication/ Disease area
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First planned submissions
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Current Phase
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News update
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Ilaris (ACZ885)
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Hereditary periodic fevers
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2016
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III
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- Umbrella pivotal trial, FPFV June 2014
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ACZ885
(canakinumab)
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Secondary prevention of cardiovascular events
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2017
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III
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- Study fully enrolled
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Afinitor/Votubia
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Non-functioning GI/lung NET
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2015
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III
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- RADIANT-4 pivotal trial results expected in Q2 2015
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TSC seizures
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2016
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III
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- Phase III study enrolling
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Diffuse large B-cell lymphoma
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e 2019
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III
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Cosentyx
(AIN457)
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Psoriatic arthritis
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2015
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III
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- Submission planned in H1 2015
- Phase III data presented at American College of Rheumatology (ACR) Congress in Nov. 2014
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Ankylosing spondylitis
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2015
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III
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- Submission planned in H1 2015
- Phase III data presented at ACR in Nov. 2014
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BAF312
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Secondary progressive MS
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e 2019
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III
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BCT197
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COPD
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e 2019
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II
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BGJ398
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Solid tumors
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e 2019
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II
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BGS649
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Obese hypogonadotropic hypogonadism
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e 2019
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II
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BKM120
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mBC ER+ AI resistant mTOR naive
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2015
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III
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- BELLE-2 pivotal trial results expected in Q2 2015
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mBC ER+ post AI and mTOR inhibitor
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2016
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III
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Solid tumors
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e 2019
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I
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BYL719
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Solid tumors
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e 2019
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I
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BYM338
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Sporadic inclusion body myositis
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2016
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III
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Hip fracture
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e 2019
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II
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Sarcopenia
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e 2019
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II
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CAD106
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Alzheimers disease
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e 2019
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II
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CJM112
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Immune disorders
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e 2019
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I
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CTL019
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Adult & pediatric acute lymphoblastic leukemia
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2016
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II
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Diffuse large B-cell lymphoma
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2017
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II
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EGF816
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Solid tumors
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e 2019
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I/II
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FCR001
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Renal Transplant
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e 2019
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II
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Fovista
(OAP030A)
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Wet AMD
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2016
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III
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Gilenya
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Chronic inflammatory demyelinating polyradiculoneuropathy
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2017
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III
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HSC835
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Stem cell transplantation
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e 2019
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II
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INC280
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Non-small cell lung cancer
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2018
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II
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KAE609
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Malaria
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2017
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II
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KAF156
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Malaria
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e 2019
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II
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LCI699
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Cushings disease
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2017
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III
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LCQ908
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Familial chylomicronemia syndrome
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2015
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III
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- Phase III study recruitment completed
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LCZ696
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Chronic heart failure with preserved ejection fraction
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e 2019
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III
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- PARAGON-HF FPFV achieved in Jul. 2014
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LEE011
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HR+, HER2 negative advanced breast cancer (in postmenopausal women)
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2016
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III
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- Phase III registration study enrolling
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HR+, HER2 negative advanced breast cancer (in premenopausal women)
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2018
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III
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- Phase III registration study enrolling
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Solid tumors
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2018
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I
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LGX818
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Solid tumors
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e 2019
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II
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LIK066
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Type II diabetes
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e 2019
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II
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LJM716
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Solid tumors
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e 2019
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I
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Lucentis
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Choroidal neovascularization and macular edema secondary to conditions other than age-related macular degeneration, diabetic macular edema, retinal vein occlusion and pathologic myopia
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2016
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III
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Retinopathy of Prematurity (ROP)
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2018
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III
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MEK1621
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NRAS mutant melanoma
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2016
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III
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- Phase III study enrolling
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Low-grade serous ovarian cancer
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2016
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III
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- Phase III study enrolling
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Solid tumors
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e 2019
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II
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� | |
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MEK1621+LGX818
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BRAF mutant melanoma
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2016
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III
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- Phase III study enrolling
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PKC412
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Aggressive systemic mastocytosis
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2015
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II
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- Final results from pivotal Phase II trial presented at American Society of Hematology Annual Meeting
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Acute myeloid leukemia
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2015
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III
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QAW039
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Asthma
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e 2019
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II
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Atopic dermatitis
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e 2019
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II
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� | |
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QAX576
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Allergic diseases
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e 2019
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II
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� | |
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QGE031
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Asthma
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e 2019
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II
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� | |
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RLX030
(serelaxin)
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Acute heart failure
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2016
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III
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- RELAX2 registration study ongoing
- RELAX-ASIA registration study ongoing
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Signifor LAR
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Cushings disease
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2016
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III
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Tasigna
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CML treatment-free remission
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2016
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II
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- Study fully enrolled
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Tekturna
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Chronic heart failure
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2016
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III
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- Phase III outcome study (ATMOSPHERE) ongoing in heart failure
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Zykadia
(LDK378)
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ALK+ advanced non-small cell lung cancer (first-line, treatment na�ve)
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2017
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III
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- Phase III study enrolling
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1 Conditional on completion of the previously announced transactions with GSK, we expect to return our rights in MEK162 to Array BioPharma Inc.
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Selected Alcon pipeline projects
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Project/ Compound
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Potential indication/ Disease area
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Planned submissions
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Current Phase
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News update
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SURGICAL
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AcrySof IQ ReSTOR IOL 2.5D
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Cataract
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US 2013
JP 2013
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Filed
Approved
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- Filing occurred Aug. 2013
- Approved Apr. 2014
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AcrySof IQ ReSTOR Toric IOL 2.5D
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Cataract
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US 2015
JP 2014
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Advanced
Filed
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�
- Filing occurred Jul. 2014
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AcrySof IQ ReSTOR 3.0D Toric IOL
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Cataract
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US 2013
JP 2013
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Filed
Approved
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- Filing occurred Aug. 2013
- Approved Jan. 2014
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AcrySof IQ ReSTOR 3.0D Toric IOL diopter range expansion
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Cataract
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US 2015
JP 2015
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Advanced
Advanced
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Intrepid IOL
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Cataract
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US 2017
EU 2016
JP 2017
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Redeveloped
Redeveloped
Redeveloped
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�
- Project being redeveloped
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Centurion Phaco Platform
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Cataract
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US 2012
EU 2013
JP 2013
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Approved
Approved
Approved
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�
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- Approved May 2014
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Verion Surgical Planning System
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Cataract
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US 2013
EU 2013
JP 2014
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Approved
Approved
Approved
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- Launched Jun. 2014
- Launched Jun. 2014
- Approved Mar. 2014
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LenSx Laser
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Cataract
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JP 2013
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Approved
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- Approved Sep. 2014
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LenSx Laser, system expansion
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Refractive
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US 2013
EU 2013
JP 2015
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Approved
Approved
Advanced
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- Approved Apr. 2013
- Approved Sep. 2013
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OPHTHALMIC PHARMACEUTICALS
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Brinzolamide/
Brimonidine fixed combination
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Glaucoma
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US 2012
EU 2013
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Approved
Approved
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- Approved Apr. 2013
- Approved Jul. 2014
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IZBA, travoprost 0.003%
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Glaucoma
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US 2013
EU 2012
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Approved
Approved
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- Approved May 2014
- Approved Feb. 2014
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JETREA
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Retina
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EU 2011
JP 2015
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Approved
Phase III
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- Approved Mar. 2013
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RTH258 (ESBA1008)
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Retina
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Phase III
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- Phase III development initiated Dec. 2014
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Olopatadine 0.77%
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Allergy
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US 2014
�
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Approved
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- Approved Dec. 2014
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EXE844
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Otic infections
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US 2014
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Filed
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- Filing occurred Apr. 2014
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VISION CARE
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New lens care solution
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Lens care solution
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US 2014
EU 2014
JP 2015
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Filed
Approved
Advanced
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- Filing occurred Sep. 2014
- Approved Sept. 2014
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�
�
Selected Sandoz pipeline projects (biosimilars)
�
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Project/ Compound
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Potential indication/ Disease area
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Submissions
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Current Phase
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News update
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EP2006 (filgrastim)
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Chemotherapy-induced neutropenia; mobilization of peripheral blood progenitor cells and others intravenous
(same as originator)
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Submitted in US in Q3
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III
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- ODAC voted for approval in all indications (14-0)
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GP2013 (rituximab)
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Non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (also known as Wegeners granulomatosis), and microscopic polyangiitis and others (same as originator)
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II and III
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- Recruitment in Phase III follicular lymphoma trial completed in Jan. 2015
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GP2015 (etanercept)
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Arthritidies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), plaque psoriasis and others (same as originator)
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III
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- Patient enrollment complete
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GP2017 (adalimumab)
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Arthritidies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), plaque psoriasis and others (same as originator)
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III
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LA-EP2006 (pegfilgrastim)
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Chemotherapy-induced neutropenia and others (same as originator)
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� |
III
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- Trial complete
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�
�
�
Selected Vaccines pipeline projects
�
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Project/ Compound
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Potential indication/ Disease area
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Planned submissions
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Current Phase
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News update
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Bexsero (US)
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Multi-component vaccine for prevention of meningococcal disease (serogroup B)
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Started
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Filing
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- FDA granted accelerated approval in January 2015
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Flucelvax (US)
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Prevention of influenza disease in persons 18 years of age and older
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Complete
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Approved
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- Approved by FDA for adults
- US BLA for age 4 and older submitted Q4 2014
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Fluad�(US)
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Prevention of seasonal influenza (trivalent subunit vaccine with MF59 adjuvant)
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2014
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Filing
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- US BLA submitted in Q4 2014
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Quadrivalent Influenza Vaccine (QIV)
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Prevention of seasonal influenza
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e2015
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III
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- Phase III trials for adjuvanted (aQIV) ongoing and cell-based (QIVc) QIVs completed
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MenABCWY
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Prevention of meningococcal disease (serogroups A, B, C, Y and W-135)
|
e2015
|
II
|
- Phase III in preparation
|
|
Group B streptococcus
|
Prevention of group B streptococcus
|
e2015
|
II
|
- Phase III in preparation
|
|
Pandemic influenza vaccines
|
Universal vaccination in case of an influenza pandemic
|
NA
|
NA
|
- H7N9 clinical study completed
- US Department of Health and Human Services (HHS) purchased stockpile
|
|
Staph. aureus
|
Prevention of Staphylococcus aureus
|
e2015
|
I
|
� |
|
TdaP
|
Prevention of Tetanus, Diphtheria, Pertussis
|
e2015
|
I
|
� |
32
�
�
�
Consolidated income statements
Fourth quarter (unaudited)
|
Q4 2014 USD m |
Q4 2013 USD m |
Change USD m |
|||||
| Net sales to third parties from continuing operations | 13�075 | 13�389 | -314 | ||||
| Sales to discontinuing segments | 55 | 51 | 4 | ||||
| Net sales from continuing operations | 13�130 | 13�440 | -310 | ||||
| Other revenues | 224 | 188 | 36 | ||||
| Cost of goods sold | -4�416 | -4�428 | 12 | ||||
| Gross profit from continuing operations | 8�938 | 9�200 | -262 | ||||
| Marketing & Sales | -3�229 | -3�451 | 222 | ||||
| Research & Development | -2�537 | -2�486 | -51 | ||||
| General & Administration | -736 | -695 | -41 | ||||
| Other income | 606 | 513 | 93 | ||||
| Other expense | -691 | -748 | 57 | ||||
| Operating income from continuing operations | 2�351 | 2�333 | 18 | ||||
| Income from associated companies | 580 | 155 | 425 | ||||
| Interest expense | -188 | -163 | -25 | ||||
| Other financial income and expense | 13 | -42 | 55 | ||||
| Income before taxes from continuing operations | 2�756 | 2�283 | 473 | ||||
| Taxes | -308 | -268 | -40 | ||||
| Net income from continuing operations | 2�448 | 2�015 | 433 | ||||
| Net loss/income from discontinuing operations | -961 | 43 | -1�004 | ||||
| Total net income | 1�487 | 2�058 | -571 | ||||
| Attributable to: | |||||||
|
Shareholders of Novartis AG
|
1�491 | 2�029 | -538 | ||||
|
Non-controlling interests
|
-4 | 29 | -33 | ||||
| Average number of shares outstanding – Basic (million) | 2�408 | 2�432 | -24 | ||||
| Basic earnings per share from continuing operations (USD)1 | 1.02 | 0.82 | 0.20 | ||||
| Basic earnings per share from discontinuing operations (USD)1 | -0.40 | 0.01 | -0.41 | ||||
| Total basic earnings per share (USD)1 | 0.62 | 0.83 | -0.21 | ||||
| Average number of shares outstanding – Diluted (million) | 2�449 | 2�469 | -20 | ||||
| Diluted earnings per share from continuing operations (USD)1 | 1.00 | 0.81 | 0.19 | ||||
| Diluted earnings per share from discontinuing operations (USD)1 | -0.39 | 0.01 | -0.40 | ||||
| Total diluted earnings per share (USD)1 | 0.61 | 0.82 | -0.21 | ||||
|
1�Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
|
|||||||
|
�
|
|||||||
33
Full year (audited)
|
FY 2014 USD m |
FY 2013 USD m |
Change USD m |
|||||
| Net sales to third parties from continuing operations | 52�180 | 51�869 | 311 | ||||
| Sales to discontinuing segments | 239 | 221 | 18 | ||||
| Net sales from continuing operations | 52�419 | 52�090 | 329 | ||||
| Other revenues | 1�215 | 626 | 589 | ||||
| Cost of goods sold | -17�345 | -16�579 | -766 | ||||
| Gross profit from continuing operations | 36�289 | 36�137 | 152 | ||||
| Marketing & Sales | -12�377 | -12�638 | 261 | ||||
| Research & Development | -9�086 | -9�071 | -15 | ||||
| General & Administration | -2�616 | -2�603 | -13 | ||||
| Other income | 1�391 | 1�205 | 186 | ||||
| Other expense | -2�512 | -2�047 | -465 | ||||
| Operating income from continuing operations | 11�089 | 10�983 | 106 | ||||
| Income from associated companies | 1�918 | 599 | 1�319 | ||||
| Interest expense | -704 | -683 | -21 | ||||
| Other financial income and expense | -31 | -92 | 61 | ||||
| Income before taxes from continuing operations | 12�272 | 10�807 | 1�465 | ||||
| Taxes | -1�545 | -1�498 | -47 | ||||
| Net income from continuing operations | 10�727 | 9�309 | 1�418 | ||||
| Net loss from discontinuing operations | -447 | -17 | -430 | ||||
| Net income | 10�280 | 9�292 | 988 | ||||
| Attributable to: | |||||||
|
Shareholders of Novartis AG
|
10�210 | 9�175 | 1�035 | ||||
|
Non-controlling interests
|
70 | 117 | -47 | ||||
| Average number of shares outstanding – Basic (million) | 2�426 | 2�441 | -15 | ||||
| Basic earnings per share from continuing operations (USD)1 | 4.39 | 3.76 | 0.63 | ||||
| Basic earnings per share from discontinuing operations (USD)1 | -0.18 | 0.00 | -0.18 | ||||
| Total basic earnings per share (USD)1 | 4.21 | 3.76 | 0.45 | ||||
| Average number of shares outstanding – Diluted (million) | 2�470 | 2�479 | -9 | ||||
| Diluted earnings per share from continuing operations (USD)1 | 4.31 | 3.70 | 0.61 | ||||
| Diluted earnings per share from discontinuing operations (USD)1 | -0.18 | 0.00 | -0.18 | ||||
| Total diluted earnings per share (USD)1 | 4.13 | 3.70 | 0.43 | ||||
|
1�Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
|
|||||||
|
�
|
|||||||
34
Fourth quarter (unaudited)
|
Q4 2014 USD m |
Q4 2013 USD m |
Change USD m |
|||||
| Net income | 1�487 | 2�058 | -571 | ||||
| Other comprehensive income to be eventually recycled into the consolidated income statement: | |||||||
|
Fair value adjustments on financial instruments, net of taxes
|
78 | -60 | 138 | ||||
|
Novartis share of other items recorded in comprehensive income recognized by associated companies, net of taxes
|
5 | 7 | -2 | ||||
|
Translation effects
|
-873 | 472 | -1�345 | ||||
|
Total of items to eventually recycle
|
-790 | 419 | -1�209 | ||||
| Other comprehensive income never to be recycled into the consolidated income statement: | |||||||
|
Net actuarial gains from defined benefit plans, net of taxes
|
320 | 344 | -24 | ||||
| Comprehensive income | 1�017 | 2�821 | -1�804 | ||||
| Attributable to: | |||||||
|
Shareholders of Novartis AG
|
1�022 | 2�791 | -1�769 | ||||
|
Continuing operations
|
2�022 | 2�740 | -718 | ||||
|
Discontinuing operations
|
-1�000 | 51 | -1�051 | ||||
|
Non-controlling interests
|
-5 | 30 | -35 | ||||
Full year (audited)
|
FY 2014 USD m |
FY 2013 USD m |
Change USD m |
|||||
| Net income | 10�280 | 9�292 | 988 | ||||
| Other comprehensive income to be eventually recycled into the consolidated income statement: | |||||||
|
Fair value adjustments on financial instruments, net of taxes
|
110 | 173 | -63 | ||||
|
Novartis share of other items recorded in comprehensive income recognized by associated companies, net of taxes
|
-5 | 5 | -10 | ||||
|
Translation effects
|
-2�220 | 676 | -2�896 | ||||
|
Total of items to eventually recycle
|
-2�115 | 854 | -2�969 | ||||
| Other comprehensive income never to be recycled into the consolidated income statement: | |||||||
|
Net actuarial (losses)/gains from defined benefit plans, net of taxes
|
-822 | 1�504 | -2�326 | ||||
| Comprehensive income | 7�343 | 11�650 | -4�307 | ||||
| Attributable to: | |||||||
|
Shareholders of Novartis AG
|
7�274 | 11�538 | -4�264 | ||||
|
Continuing operations
|
7�820 | 11�512 | -3�692 | ||||
|
Discontinuing operations
|
-546 | 26 | -572 | ||||
|
Non-controlling interests
|
69 | 112 | -43 | ||||
35
|
Dec 31, 2014 USD m |
Dec 31, 2013 USD m |
Change USD m |
|||||
| Assets | |||||||
| Non-current assets | |||||||
| Property, plant & equipment | 15�983 | 18�197 | -2�214 | ||||
| Goodwill | 29�311 | 31�026 | -1�715 | ||||
| Intangible assets other than goodwill | 23�832 | 27�841 | -4�009 | ||||
| Financial and other non-current assets | 18�700 | 18�648 | 52 | ||||
| Total non-current assets | 87�826 | 95�712 | -7�886 | ||||
| Current assets | |||||||
| Inventories | 6�093 | 7�267 | -1�174 | ||||
| Trade receivables | 8�275 | 9�902 | -1�627 | ||||
| Other current assets | 2�530 | 3�392 | -862 | ||||
| Cash and cash equivalents, marketable securities, commodities and derivatives | 13�862 | 9�222 | 4�640 | ||||
| Assets related to discontinuing operations | 6�801 | 759 | 6�042 | ||||
| Total current assets | 37�561 | 30�542 | 7�019 | ||||
| Total assets | 125�387 | 126�254 | -867 | ||||
| Equity and liabilities | |||||||
| Equity attributable to Novartis AG shareholders | 70�766 | 74�343 | -3�577 | ||||
| Non-controlling interests | 78 | 129 | -51 | ||||
| Total equity | 70�844 | 74�472 | -3�628 | ||||
| Non-current liabilities | |||||||
| Financial debts | 13�799 | 11�242 | 2�557 | ||||
| Other non-current liabilities | 13�771 | 14�172 | -401 | ||||
| Total non-current liabilities | 27�570 | 25�414 | 2�156 | ||||
| Current liabilities | |||||||
| Trade payables | 5�419 | 6�148 | -729 | ||||
| Financial debts and derivatives | 6�612 | 6�776 | -164 | ||||
| Other current liabilities | 12�524 | 13�394 | -870 | ||||
| Liabilities related to discontinuing operations | 2�418 | 50 | 2�368 | ||||
| Total current liabilities | 26�973 | 26�368 | 605 | ||||
| Total liabilities | 54�543 | 51�782 | 2�761 | ||||
| Total equity and liabilities | 125�387 | 126�254 | -867 | ||||
|
�
|
|||||||
36
Fourth quarter (unaudited)
|
Q4 2014 USD m |
Q4 2013 USD m |
Change USD m |
|||||
| Consolidated equity at October 1 | 71�424 | 72�179 | -755 | ||||
| Comprehensive income | 1�017 | 2�821 | -1�804 | ||||
| Purchase of treasury shares | -1�891 | -770 | -1�121 | ||||
| Treasury share repurchase commitment under a share buy-back trading plan | 17 | 17 | |||||
| Increase in equity from exercise of options and employee transactions | 3 | 12 | -9 | ||||
| Equity-based compensation | 277 | 263 | 14 | ||||
| Change in non-controlling interests | -3 | -33 | 30 | ||||
| Consolidated equity at December 31 | 70�844 | 74�472 | -3�628 | ||||
|
�
|
|||||||
Full year (audited)
|
FY 2014 USD m |
FY 2013 USD m |
Change USD m |
|||||
| Consolidated equity at January 1 | 74�472 | 69�263 | 5�209 | ||||
| Comprehensive income | 7�343 | 11�650 | -4�307 | ||||
| Purchase of treasury shares | -6�926 | -2�990 | -3�936 | ||||
| Treasury share repurchase commitment under a share buy-back trading plan | -658 | -658 | |||||
| Increase in equity from exercise of options and employee transactions | 2�400 | 1�691 | 709 | ||||
| Dividends related to shareholders of Novartis AG | -6�810 | -6�100 | -710 | ||||
| Equity-based compensation | 1�143 | 1�077 | 66 | ||||
| Impact of change in ownership of consolidated entities | -10 | 10 | |||||
| Change in non-controlling interests | -120 | -109 | -11 | ||||
| Consolidated equity at December 31 | 70�844 | 74�472 | -3�628 | ||||
|
�
|
|||||||
37
Fourth quarter (unaudited)
|
Q4 2014 USD m |
Q4 2013 USD m |
Change USD m |
|||||
| Net income from continuing operations | 2�448 | 2�015 | 433 | ||||
| Reversal of non-cash items | |||||||
|
Taxes
|
308 | 268 | 40 | ||||
|
Depreciation, amortization and impairments
|
1�291 | 1�211 | 80 | ||||
|
Change in provisions and other non-current liabilities
|
316 | 204 | 112 | ||||
|
Income from associated companies
|
-580 | -155 | -425 | ||||
|
Net financial income
|
175 | 205 | -30 | ||||
|
Other
|
-118 | -6 | -112 | ||||
| Net income adjusted for non-cash items | 3�840 | 3�742 | 98 | ||||
| Interest and other financial receipts | 394 | -65 | 459 | ||||
| Interest and other financial payments | -168 | -90 | -78 | ||||
| Taxes paid1 | -559 | -509 | -50 | ||||
| Cash flows before working capital changes from continuing operations | 3�507 | 3�078 | 429 | ||||
| Payments out of provisions and other net cash movements in non-current liabilities | -251 | -302 | 51 | ||||
| Change in net current assets and other operating cash flow items | 1�467 | 1�186 | 281 | ||||
| Cash flows from operating activities from continuing operations | 4�723 | 3�962 | 761 | ||||
| Cash flows from operating activities from discontinuing operations 1 | 482 | 488 | -6 | ||||
| Total cash flows from operating activities | 5�205 | 4�450 | 755 | ||||
| Purchase of property, plant & equipment | -830 | -1�048 | 218 | ||||
| Purchase of intangible, financial and other non-current assets | -304 | -218 | -86 | ||||
| Proceeds from sales of property, plant & equipment, intangible, financial and other non-current assets | 366 | 179 | 187 | ||||
| Acquisitions of businesses | -350 | -350 | |||||
| Change in marketable securities, commodities and net divestment proceeds of associated companies | 331 | -1�524 | 1�855 | ||||
| Cash flows used in investing activities from continuing operations | -787 | -2�611 | 1�824 | ||||
| Cash flows used in investing activities from discontinuing operations 1 | -132 | -44 | -88 | ||||
| Total cash flows used in investing activities | -919 | -2�655 | 1�736 | ||||
| Change in current and non-current financial debts | 1�157 | -746 | 1�903 | ||||
| Treasury share transactions, net | -1�899 | -707 | -1�192 | ||||
| Other financing cash flows | -65 | 65 | |||||
| Cash flows used in financing activities | -742 | -1�518 | 776 | ||||
| Net translation effect on cash and cash equivalents | -162 | 47 | -209 | ||||
| Change in cash and cash equivalents | 3�382 | 324 | 3�058 | ||||
| Cash and cash equivalents at October 1 | 9�641 | 6�363 | 3�278 | ||||
| Cash and cash equivalents at December 31 | 13�023 | 6�687 | 6�336 | ||||
|
1�In Q4 2014, total Group tax payments amounted to USD 692 million when also taking into account payments of USD 19 million and USD 114 million, included in the cash flows from operating activities and investing activities, respectively, of discontinuing operations.
|
|||||||
38
Full year (audited)
|
FY 2014 USD m |
FY 2013 USD m |
Change USD m |
|||||
| Net income from continuing operations | 10�727 | 9�309 | 1�418 | ||||
| Reversal of non-cash items | |||||||
|
Taxes
|
1�545 | 1�498 | 47 | ||||
|
Depreciation, amortization and impairments
|
4�751 | 4�462 | 289 | ||||
|
Change in provisions and other non-current liabilities
|
1�490 | 736 | 754 | ||||
|
Income from associated companies
|
-1�918 | -599 | -1�319 | ||||
|
Net financial income
|
735 | 775 | -40 | ||||
|
Other
|
122 | 307 | -185 | ||||
| Net income adjusted for non-cash items | 17�452 | 16�488 | 964 | ||||
| Interest and other financial receipts | 1�067 | 539 | 528 | ||||
| Interest and other financial payments | -692 | -631 | -61 | ||||
| Taxes paid1 | -2�179 | -2�054 | -125 | ||||
| Cash flows before working capital changes from continuing operations | 15�648 | 14�342 | 1�306 | ||||
| Payments out of provisions and other net cash movements in non-current liabilities | -1�125 | -947 | -178 | ||||
| Change in net current assets and other operating cash flow items | -625 | -778 | 153 | ||||
| Cash flows from operating activities from continuing operations | 13�898 | 12�617 | 1�281 | ||||
| Cash flows used in/from operating activities from discontinuing operations 1 | -1 | 557 | -558 | ||||
| Total cash flows from operating activities | 13�897 | 13�174 | 723 | ||||
| Purchase of property, plant & equipment | -2�624 | -2�903 | 279 | ||||
| Purchase of intangible, financial and other non-current assets | -1�079 | -665 | -414 | ||||
| Proceeds from sales of property, plant & equipment, intangible, financial and other non-current assets | 739 | 472 | 267 | ||||
| Acquisitions of businesses | -331 | -42 | -289 | ||||
| Change in marketable securities, commodities and net divestment proceeds of associated companies | 3�287 | -81 | 3�368 | ||||
| Cash flows used in investing activities from continuing operations | -8 | -3�219 | 3�211 | ||||
| Cash flows from/used in investing activities from discontinuing operations 1 | 889 | -133 | 1�022 | ||||
| Total cash flows from/used in investing activities | 881 | -3�352 | 4�233 | ||||
| Dividends related to shareholders of Novartis AG | -6�810 | -6�100 | -710 | ||||
| Change in current and non-current financial debts | 3�318 | -1�333 | 4�651 | ||||
| Treasury share transactions, net | -4�515 | -1�237 | -3�278 | ||||
| Impact of change in ownership of consolidated enities | 4 | -4 | |||||
| Other financing cash flows | -140 | -103 | -37 | ||||
| Cash flows used in financing activities | -8�147 | -8�769 | 622 | ||||
| Net translation effect on cash and cash equivalents | -295 | 82 | -377 | ||||
| Change in cash and cash equivalents | 6�336 | 1�135 | 5�201 | ||||
| Cash and cash equivalents at January 1 | 6�687 | 5�552 | 1�135 | ||||
| Cash and cash equivalents at December 31 | 13�023 | 6�687 | 6�336 | ||||
|
1�In FY 2014, total Group tax payments amounted to USD 2.6 billion when also taking into account payments of USD 7 million and USD 459 million, included in the cash flows from operating activities and investing activities, respectively, of discontinuing operations.
|
|||||||
39
1. Basis of preparation
These Condensed Interim Consolidated Financial Statements for the three- and twelve-month periods ended December 31, 2014, were prepared in accordance with International Accounting Standard 34 Interim Financial Reporting and accounting policies set out in the 2014 Annual Report published on January�27, 2015.
2. Selected critical accounting policies
The Group’s principal accounting policies are set out in note 1 to the Consolidated Financial Statements in the 2014 Annual Report and conform with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board. The presentation of financial statements requires management to make subjective and complex judgments that affect the reported amounts. Because of the inherent uncertainties, actual outcomes and results may differ from management’s assumptions and estimates. In particular, as discussed in note 11 of the 2014 Annual Report, goodwill, Alcon brand name and acquired In-Process Research & Development projects are reviewed for impairment at least annually and these, as well as all other investments in intangible assets, are reviewed for impairment whenever an event or decision occurs that raises concern about their balance sheet carrying value. The amount of goodwill and other intangible assets on the Group’s consolidated balance sheet has risen significantly in recent years, primarily from acquisitions. Impairment testing under IFRS may lead to potentially significant impairment charges in the future that could have a materially adverse impact on the Group’s financial results.
The determination of the contingent consideration in respect of acquisitions also requires management to make assumptions on the probability and amount of potential payments due to previous owners. If actual payments are different to the estimated amounts recorded for contingent consideration there could be a significant impact, either positive or negative, on the Group’s financial results.
3. Significant transactions
Vaccines – Divestment of blood transfusion diagnostics unit
On January 9, 2014, Novartis completed the divestment of its blood transfusion diagnostics unit to the Spanish company Grifols S.A., for USD 1.7 billion in cash. The pre-tax gain on this transaction was approximately USD 0.9 billion and was recorded in operating income from discontinuing operations.
Pharmaceuticals – Acquisition of CoStim Pharmaceuticals, Inc.
On February 17, 2014, Novartis acquired all of the outstanding shares of CoStim Pharmaceuticals, Inc., a Cambridge, Massachusetts, US-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer, for a total purchase consideration of USD 248 million (excluding cash acquired). This amount consists of an initial cash payment and the net present value of contingent consideration of USD 153 million due to previous CoStim’s shareholders, which they are eligible to receive upon the achievement of specified development and commercialization milestones. The purchase price allocation resulted in net identified assets of USD 152 million (excluding cash acquired) and goodwill of USD 96 million. Results of operations since the acquisition were not material.
Pharmaceuticals – Divestment of Idenix Pharmaceuticals, Inc. (Idenix) shareholding
On August 5, 2014, Merck & Co., USA completed a tender offer for Idenix. As a result, Novartis divested its 22% shareholding in Idenix and realized a gain of approximately USD 0.8 billion which was recorded in income from associated companies.
Corporate – Divestment of LTS Lohmann Therapie-Systeme AG (LTS) shareholding
On November 5, 2014, Novartis divested its 43% shareholding in LTS and realized a gain of approximately USD 0.4 billion which was recorded in income from associated companies.
40
On October 16, 2014, Alcon acquired all of the outstanding shares of WaveTec, a privately held company, for USD 350 million in cash. The purchase price allocation resulted in net identified assets of USD 180 million and goodwill of USD 170 million. Results of operations since the acquisition were not material.
Major pending transactions
Transaction with Eli Lilly and Company
On April 22, 2014, Novartis entered into an agreement with Eli Lilly and Company, USA (Lilly) to divest its Animal Health business to Lilly for approximately USD 5.4 billion in cash to be paid on closing. This transaction closed on January 1, 2015 and will result in a pre-tax gain of approximately USD 4.6 billion.
Transactions with GlaxoSmithKline plc
On April 22, 2014 (and as amended and restated on May 29, 2014), Novartis entered into the following agreements with GlaxoSmithKline plc, Great Britain (GSK). These transactions with GSK are inter-conditional and were approved by GSK shareholders in December 2014. They are still subject to other closing conditions, including regulatory approvals. The transactions are expected to close during the first half of 2015.
Pharmaceuticals – Acquisition of GSK oncology products
Novartis has agreed to acquire GSK’s oncology products for an aggregate cash consideration of USD 16 billion. Up to USD 1.5 billion of this cash consideration is contingent on certain development milestones. In addition, under the terms of the agreement, Novartis was granted a right of first negotiation over the co-development or commercialization to GSK’s current and future oncology R&D pipeline, excluding oncology vaccines. The right of first negotiation is for a period of 12.5 years, from the acquisition closing date.
Vaccines – Divestment
Novartis has agreed to divest its Vaccines business to GSK for up to USD 7.1 billion plus royalties. The USD 7.1 billion consists of USD 5.25 billion to be paid on closing and up to USD 1.8 billion in future milestone payments. Novartis’s Vaccines influenza business is excluded from the GSK Vaccines business acquisition. However, GSK has entered into a future option arrangement with Novartis in relation to the Vaccines influenza business, pursuant to which Novartis may unilaterally require GSK to acquire the entire or certain parts of its vaccines influenza business for consideration of up to USD 250 million (the Influenza Put Option) if the divestment to CSL Limited, Australia (CSL), discussed below, is not completed. The option period is 18 months, beginning the earlier of the GSK transaction closing date and October�22, 2015. Novartis paid GSK a fee of USD 5 million in consideration for the grant of the Influenza Put Option.
Consumer Health – Combination of Novartis OTC with GSK consumer healthcare in a joint venture
Novartis and GSK have agreed to create a combined consumer healthcare business through a joint venture between Novartis OTC and GSK consumer healthcare. Upon completion, Novartis will own a 36.5% share of the joint venture and will have four of eleven seats on the joint venture’s Board. Furthermore, Novartis will have customary minority rights and also exit rights at a pre-defined, market-based pricing mechanism. The investment will be accounted for using the equity method of accounting.
Transaction with CSL
On October 26, 2014 Novartis entered into a transaction with CSL to sell its Vaccines influenza business to CSL for USD 275 million. This transaction is expected to be completed in the second half of 2015, subject to all necessary regulatory approvals.
Entering into the separate divestment agreement with CSL resulted in the vaccine influenza business being a separate cash generating unit within the Vaccines Division, requiring the performance of a separate valuation of the influenza vaccines business net assets. This triggered the recognition of an exceptional impairment charge of approximately USD 1.1 billion (pre-tax), as the book value of the influenza vaccines business net assets was above the USD 275 million consideration to be paid by CSL.
41
These major pending transactions, combined with the divestment of the blood transfusion diagnostics unit which closed on January 9, 2014, result from the portfolio review which commenced in mid-2013.
As a result, Novartis is required to separate the Group’s reported financial data for the current and prior year into “discontinuing” and “continuing” operations.
Discontinuing operations include the Animal Health Division, the OTC Division, and the Vaccines Division including the USD 0.9 billion pre-tax gain arising from the USD 1.7 billion divestment of the blood transfusion diagnostics unit to Grifols S.A., completed on January 9, 2014, and related prior-year results for this unit’s activity. Excluded from discontinuing operations are certain intellectual property rights and related other revenues of the Vaccines Division which are retained by Novartis and are now reported under Corporate activities. Also included in discontinuing operations, under Corporate, are certain transaction related expenses.
As required by IFRS, 2014 results exclude from the portfolio transformation announcement date any further depreciation and amortization related to discontinuing operations.
Continuing operations comprise all other activities of the Novartis Group, including the Pharmaceuticals, Alcon and Sandoz Divisions and the retained Corporate activities.
Continuing operations do not yet include the results from Oncology assets to be acquired from GSK on closing of the transaction or the results from the 36.5% interest in the GSK/Novartis consumer healthcare joint venture that will be created at the same time.
There were no significant acquisition or divestment transactions in 2013.
42
| Number of outstanding shares (in millions) | Issued share capital and reserves attributable to Novartis AG shareholders | ||||||||||||
|
2014 |
2013 |
Change |
FY 2014 USD m |
FY 2013 USD m |
Change USD m |
||||||||
| Balance at beginning of year | 2�426.1 | 2�420.6 | 5.5 | 74�343 | 69�137 | 5�206 | |||||||
| Shares acquired to be held in Group Treasury | -46.8 | -33.3 | -13.5 | -4�057 | -2�464 | -1�593 | |||||||
| Shares acquired to be cancelled | -27.0 | -2.2 | -24.8 | -2�396 | -170 | -2�226 | |||||||
| Other share purchases | -5.4 | -4.8 | -0.6 | -473 | -356 | -117 | |||||||
| Increase in equity from exercise of options and employee transactions | 41.4 | 34.3 | 7.1 | 2�400 | 1�691 | 709 | |||||||
| Equity-based compensation | 10.3 | 11.5 | -1.2 | 1�143 | 1�077 | 66 | |||||||
| Treasury share repurchase commitment under a share buy-back trading plan | -658 | -658 | |||||||||||
| Dividends | -6�810 | -6�100 | -710 | ||||||||||
| Net income of the period attributable to shareholders of Novartis AG | 10�210 | 9�175 | 1�035 | ||||||||||
| Other comprehensive income attributable to shareholders of Novartis AG | -2�936 | 2�363 | -5�299 | ||||||||||
| Impact of change in ownership of consolidated entities | -10 | 10 | |||||||||||
| Balance at December 31 | 2�398.6 | 2�426.1 | -27.5 | 70�766 | 74�343 | -3�577 | |||||||
|
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|
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|
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43
| Pharmaceuticals | Alcon | Sandoz | Corporate | Total continuing operations | Total discontinuing operations | Group eliminations | Total Group | ||||||||||||||||||||||||||
|
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
||||||||||||||||||
| Net sales to third parties | 7�860 | 8�323 | 2�703 | 2�655 | 2�512 | 2�411 | 13�075 | 13�389 | 1�558 | 1�689 | 14�633 | 15�078 | |||||||||||||||||||||
| Sales to other segments | 61 | 35 | 11 | 10 | 70 | 77 | -87 | -71 | 55 | 51 | 14 | 14 | -69 | -65 | |||||||||||||||||||
| Net sales | 7�921 | 8�358 | 2�714 | 2�665 | 2�582 | 2�488 | -87 | -71 | 13�130 | 13�440 | 1�572 | 1�703 | -69 | -65 | 14�633 | 15�078 | |||||||||||||||||
| Other revenues | 171 | 127 | 10 | 7 | 3 | 6 | 40 | 48 | 224 | 188 | 16 | 97 | 240 | 285 | |||||||||||||||||||
| Cost of goods sold | -1�709 | -1�773 | -1�320 | -1�308 | -1�527 | -1�480 | 140 | 133 | -4�416 | -4�428 | -1�022 | -949 | 69 | 65 | -5�369 | -5�312 | |||||||||||||||||
| Gross profit | 6�383 | 6�712 | 1�404 | 1�364 | 1�058 | 1�014 | 93 | 110 | 8�938 | 9�200 | 566 | 851 | 0 | 0 | 9�504 | 10�051 | |||||||||||||||||
| Marketing & Sales | -2�157 | -2�357 | -641 | -648 | -431 | -446 | -3�229 | -3�451 | -447 | -503 | -3�676 | -3�954 | |||||||||||||||||||||
| Research & Development | -2�073 | -1�990 | -247 | -287 | -217 | -209 | -2�537 | -2�486 | -216 | -211 | -2�753 | -2�697 | |||||||||||||||||||||
| General & Administration | -294 | -272 | -162 | -150 | -102 | -104 | -178 | -169 | -736 | -695 | -108 | -127 | -844 | -822 | |||||||||||||||||||
| Other income | 215 | 317 | 42 | 51 | 37 | 41 | 312 | 104 | 606 | 513 | 91 | 53 | -8 | -4 | 689 | 562 | |||||||||||||||||
| Other expense | -463 | -397 | -31 | -158 | -55 | -20 | -142 | -173 | -691 | -748 | -1�065 | -23 | 8 | 4 | -1�748 | -767 | |||||||||||||||||
| Operating income | 1�611 | 2�013 | 365 | 172 | 290 | 276 | 85 | -128 | 2�351 | 2�333 | -1�179 | 40 | 0 | 0 | 1�172 | 2�373 | |||||||||||||||||
| as % of net sales | 20.5% | 24.2% | 13.5% | 6.5% | 11.5% | 11.4% | 18.0% | 17.4% | -75.7% | 2.4% | 8.0% | 15.7% | |||||||||||||||||||||
| Income from associated companies | 1 | 579 | 155 | 580 | 155 | -1 | -1 | 579 | 154 | ||||||||||||||||||||||||
| Interest expense | -188 | -163 | -188 | -163 | |||||||||||||||||||||||||||||
| Other financial income and expense | 13 | -42 | 13 | -42 | |||||||||||||||||||||||||||||
| Income before taxes | 2�756 | 2�283 | -1�180 | 39 | 1�576 | 2�322 | |||||||||||||||||||||||||||
| Taxes | -308 | -268 | 219 | 4 | -89 | -264 | |||||||||||||||||||||||||||
| Net income | 2�448 | 2�015 | -961 | 43 | 1�487 | 2�058 | |||||||||||||||||||||||||||
|
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|
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44
| Pharmaceuticals | Alcon | Sandoz | Corporate | Total continuing operations | Total discontinuing operations | Group eliminations | Total Group | ||||||||||||||||||||||||||
|
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
||||||||||||||||||
| Net sales to third parties | 31�791 | 32�214 | 10�827 | 10�496 | 9�562 | 9�159 | 52�180 | 51�869 | 5�816 | 6�051 | 57�996 | 57�920 | |||||||||||||||||||||
| Sales to other segments | 262 | 202 | 49 | 50 | 286 | 294 | -358 | -325 | 239 | 221 | 78 | 72 | -317 | -293 | |||||||||||||||||||
| Net sales | 32�053 | 32�416 | 10�876 | 10�546 | 9�848 | 9�453 | -358 | -325 | 52�419 | 52�090 | 5�894 | 6�123 | -317 | -293 | 57�996 | 57�920 | |||||||||||||||||
| Other revenues | 629 | 497 | 34 | 27 | 12 | 18 | 540 | 84 | 1�215 | 626 | 65 | 285 | 1�280 | 911 | |||||||||||||||||||
| Cost of goods sold | -6�889 | -6�655 | -5�193 | -4�900 | -5�751 | -5�476 | 488 | 452 | -17�345 | -16�579 | -3�073 | -3�322 | 317 | 293 | -20�101 | -19�608 | |||||||||||||||||
| Gross profit | 25�793 | 26�258 | 5�717 | 5�673 | 4�109 | 3�995 | 670 | 211 | 36�289 | 36�137 | 2�886 | 3�086 | 0 | 0 | 39�175 | 39�223 | |||||||||||||||||
| Marketing & Sales | -8�178 | -8�514 | -2�474 | -2�452 | -1�725 | -1�672 | -12�377 | -12�638 | -1�812 | -1�911 | -14�189 | -14�549 | |||||||||||||||||||||
| Research & Development | -7�331 | -7�242 | -928 | -1�042 | -827 | -787 | -9�086 | -9�071 | -857 | -781 | -9�943 | -9�852 | |||||||||||||||||||||
| General & Administration | -1�009 | -1�051 | -613 | -589 | -376 | -374 | -618 | -589 | -2�616 | -2�603 | -431 | -457 | -3�047 | -3�060 | |||||||||||||||||||
| Other income | 734 | 699 | 79 | 79 | 97 | 106 | 481 | 321 | 1�391 | 1�205 | 1�007 | 174 | -18 | -12 | 2�380 | 1�367 | |||||||||||||||||
| Other expense | -1�538 | -774 | -184 | -437 | -190 | -240 | -600 | -596 | -2�512 | -2�047 | -1�146 | -184 | 18 | 12 | -3�640 | -2�219 | |||||||||||||||||
| Operating income | 8�471 | 9�376 | 1�597 | 1�232 | 1�088 | 1�028 | -67 | -653 | 11�089 | 10�983 | -353 | -73 | 0 | 0 | 10�736 | 10�910 | |||||||||||||||||
| as % of net sales | 26.6% | 29.1% | 14.8% | 11.7% | 11.4% | 11.2% | 21.3% | 21.2% | -6.1% | -1.2% | 18.5% | 18.8% | |||||||||||||||||||||
| Income from associated companies | 812 | 4 | 2 | 1�102 | 597 | 1�918 | 599 | 2 | 1 | 1�920 | 600 | ||||||||||||||||||||||
| Interest expense | -704 | -683 | -704 | -683 | |||||||||||||||||||||||||||||
| Other financial income and expense | -31 | -92 | -31 | -92 | |||||||||||||||||||||||||||||
| Income before taxes | 12�272 | 10�807 | -351 | -72 | 11�921 | 10�735 | |||||||||||||||||||||||||||
| Taxes | -1�545 | -1�498 | -96 | 55 | -1�641 | -1�443 | |||||||||||||||||||||||||||
| Net income | 10�727 | 9�309 | -447 | -17 | 10�280 | 9�292 | |||||||||||||||||||||||||||
|
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|
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|
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|
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45
| Vaccines as previously published 1 | Consumer Health | Transfers to continuing Corporate 2 | Corporate (including eliminations) | Discontinuing operations | |||||||||||||||||
|
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
||||||||||||
| Net sales to third parties of discontinuing operations | 494 | 655 | 1�064 | 1�034 | 1�558 | 1�689 | |||||||||||||||
| Sales to other segments | 19 | 11 | -5 | 3 | 14 | 14 | |||||||||||||||
| Net sales of discontinuing operations | 513 | 666 | 1�059 | 1�037 | 1�572 | 1�703 | |||||||||||||||
| Other revenues | 8 | 135 | 8 | 10 | -48 | 16 | 97 | ||||||||||||||
| Cost of goods sold | -584 | -511 | -438 | -442 | 4 | -1�022 | -949 | ||||||||||||||
| Gross profit of discontinuing operations | -63 | 290 | 629 | 605 | -44 | 566 | 851 | ||||||||||||||
| Marketing & Sales | -74 | -91 | -373 | -412 | -447 | -503 | |||||||||||||||
| Research & Development | -141 | -132 | -75 | -79 | -216 | -211 | |||||||||||||||
| General & Administration | -32 | -38 | -76 | -87 | -2 | -108 | -127 | ||||||||||||||
| Other income | 10 | 24 | 83 | 22 | -2 | 7 | 91 | 53 | |||||||||||||
| Other expense | -784 | -11 | -16 | -1 | 1 | -265 | -12 | -1�065 | -23 | ||||||||||||
| Operating loss/income of discontinuing operations | -1�084 | 42 | 172 | 48 | -43 | -267 | -7 | -1�179 | 40 | ||||||||||||
| as % of net sales | -219.4% | 6.4% | 16.2% | 4.6% | -75.7% | 2.4% | |||||||||||||||
| Income from associated companies | -1 | -1 | -1 | -1 | |||||||||||||||||
| Loss/income before taxes of discontinuing operations | -1�180 | 39 | |||||||||||||||||||
| Taxes | 219 | 4 | |||||||||||||||||||
| Net loss/income of discontinuing operations | -961 | 43 | |||||||||||||||||||
|
1�2013 includes the divested blood transfusion diagnostics unit
|
|||||||||||||||||||||
|
2�Other revenue contains royalties and out-licensing revenues of Vaccines which are to be retained by Novartis.
|
|||||||||||||||||||||
46
| Vaccines as previously published 1 | Consumer Health | Transfers to continuing Corporate 2 | Corporate (including eliminations) | Discontinuing operations | |||||||||||||||||
|
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
||||||||||||
| Net sales to third parties of discontinuing operations | 1�537 | 1�987 | 4�279 | 4�064 | 5�816 | 6�051 | |||||||||||||||
| Sales to other segments | 65 | 61 | 13 | 11 | 78 | 72 | |||||||||||||||
| Net sales of discontinuing operations | 1�602 | 2�048 | 4�292 | 4�075 | 5�894 | 6�123 | |||||||||||||||
| Other revenues | 32 | 333 | 33 | 36 | -84 | 65 | 285 | ||||||||||||||
| Cost of goods sold | -1�336 | -1�578 | -1�737 | -1�751 | 7 | -3�073 | -3�322 | ||||||||||||||
| Gross profit of discontinuing operations | 298 | 803 | 2�588 | 2�360 | -77 | 2�886 | 3�086 | ||||||||||||||
| Marketing & Sales | -280 | -334 | -1�532 | -1�577 | -1�812 | -1�911 | |||||||||||||||
| Research & Development | -545 | -476 | -312 | -305 | -857 | -781 | |||||||||||||||
| General & Administration | -118 | -140 | -313 | -316 | -1 | -431 | -457 | ||||||||||||||
| Other income | 905 | 70 | 99 | 79 | 3 | 25 | 1�007 | 174 | |||||||||||||
| Other expense | -812 | -88 | -60 | -63 | 4 | -274 | -37 | -1�146 | -184 | ||||||||||||
| Operating loss of discontinuing operations | -552 | -165 | 470 | 178 | -73 | -271 | -13 | -353 | -73 | ||||||||||||
| as % of net sales | -35.9% | -8.3% | 11.0% | 4.4% | -6.1% | -1.2% | |||||||||||||||
| Income from associated companies | 2 | 1 | 2 | 1 | |||||||||||||||||
| Loss before taxes of discontinuing operations | -351 | -72 | |||||||||||||||||||
| Taxes | -96 | 55 | |||||||||||||||||||
| Net loss of discontinuing operations | -447 | -17 | |||||||||||||||||||
|
�
|
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|
1�2013 includes the divested blood transfusion diagnostics unit
|
|||||||||||||||||||||
|
2�Other revenue contains royalties and out-licensing revenues of Vaccines which are to be retained by Novartis.
|
|||||||||||||||||||||
47
|
Dec 31, 2014 USD m |
Dec 31, 2013 USD m |
||||
| Assets | |||||
| Property, plant & equipment | 1�411 | 145 | |||
| Goodwill and other intangible assets | 2�462 | 358 | |||
| Financial and other non-current assets | 352 | 10 | |||
| Inventories | 1�155 | 87 | |||
| Trade receivables and other current assets | 1�421 | 159 | |||
| Total assets related to discontinuing operations and held for sale | 6�801 | 759 | |||
| Liabilities | |||||
| Other non-current liabilities | 706 | ||||
| Trade payables and other current liabilities | 1�712 | 50 | |||
| Total liabilities related to discontinuing operations and held for sale | 2�418 | 50 | |||
48
The following table illustrates the three hierarchical levels for valuing financial instruments at fair value and also those measured at amortized cost or at cost as of December 31, 2014 and December�31, 2013. For additional information on the hierarchies and other matters, please refer to the Consolidated Financial Statements in the 2014 Annual Report, published on January 27, 2015.
| Level 1 | Level 2 | Level 3 | Valued at amortized cost or cost | Total | |||||||||||||||||
|
Dec 31, 2014 (audited) USD m |
Dec 31, 2013 (audited) USD m |
Dec 31, 2014 (audited) USD m |
Dec 31, 2013 (audited) USD m |
Dec 31, 2014 (audited) USD m |
Dec 31, 2013 (audited) USD m |
Dec 31, 2014 (audited) USD m |
Dec 31, 2013 (audited) USD m |
Dec 31, 2014 (audited) USD m |
Dec 31, 2013 (audited) USD m |
||||||||||||
| Debt securities | 301 | 294 | 26 | 29 | 327 | 323 | |||||||||||||||
| Equity securities | 15 | 21 | 26 | 15 | 47 | ||||||||||||||||
| Fund investments | 29 | 6 | 11 | 35 | 11 | ||||||||||||||||
| Total available-for-sale marketable securities | 345 | 315 | 26 | 29 | 6 | 37 | 377 | 381 | |||||||||||||
| Time deposits with original maturity more than 90 days | 6 | 1�931 | 6 | 1�931 | |||||||||||||||||
| Derivative financial instruments | 356 | 121 | 356 | 121 | |||||||||||||||||
| Accrued interest on debt securities | 3 | 5 | 3 | 5 | |||||||||||||||||
| Total marketable securities, time deposits and derivative financial instruments | 345 | 315 | 382 | 150 | 6 | 37 | 9 | 1�936 | 742 | 2�438 | |||||||||||
| Available-for-sale financial investments | 605 | 458 | 332 | 366 | 937 | 824 | |||||||||||||||
| Fund investments | 71 | 52 | 71 | 52 | |||||||||||||||||
| Long-term loans and receivables, advances, security deposits | 712 | 647 | 712 | 647 | |||||||||||||||||
| Financial investments and long-term loans | 605 | 458 | 403 | 418 | 712 | 647 | 1�720 | 1�523 | |||||||||||||
| Associated companies | 66 | 168 | 234 | ||||||||||||||||||
| Total associated companies at fair value through profit or loss | 66 | 168 | 234 | ||||||||||||||||||
| Contingent consideration | -756 | -572 | -756 | -572 | |||||||||||||||||
| Derivative financial instruments | -52 | -103 | -52 | -103 | |||||||||||||||||
| Total financial liabilities at fair value | -52 | -103 | -756 | -572 | -808 | -675 | |||||||||||||||
With effect from January 1, 2014, in order to have consistent valuation methods for all venture capital fund investments, the Group has commenced valuing its fund investments with a voting share interest in excess of 20%, at fair value instead of using the equity method of accounting. For reasons of materiality this new accounting policy is applied prospectively. Apart from this change, there were no other changes in the full year to the valuation techniques used for financial instruments nor significant transfers from one level to the other nor significant transactions associated with level 3 financial instruments.
The fair value of straight bonds amounted to USD�17.0 billion at December 31, 2014 (USD�13.5 billion at December�31, 2013) compared to the balance sheet value of USD�16.0 billion (USD�12.9 billion at December�31, 2013). For all other financial assets and liabilities, the carrying amount is a reasonable approximation of the fair value. The carrying amount of financial assets included in the line financial and other non-current assets amounted to USD�1.7 billion at December 31, 2014 (USD�1.5 billion at December�31, 2013).
The Group’s exposure to financial risks has not changed significantly during the period and there have been no major changes to the risk management department or in any risk management policies.
49
A number of Novartis companies are, and will likely continue to be, subject to various legal proceedings, including litigations, arbitrations and governmental investigations, that arise from time to time. Legal proceedings are inherently unpredictable. As a result, the Group may become subject to substantial liabilities that may not be covered by insurance and may in the future incur judgments or enter into settlements of claims that could have a material adverse effect on its results of operations or cash flow. Note 20 to the consolidated financial statements contained in our annual report for the year ended December 31, 2013 contains a summary as of the date of that report of significant legal proceedings to which Novartis or its subsidiaries were a party. The following is a summary as of January 26, 2015 of potentially significant developments in those proceedings, as well as any new potentially significant proceedings commenced since the date of the last annual report. Reference is also made to note 20 to the consolidated financial statements contained in our annual report for the year ended December 31, 2014 for a summary of significant legal proceedings.
Investigations and related litigations
Southern District of New York (SDNY) marketing practices investigation and litigation
In April 2013, the US government filed a civil complaint in intervention to an individual qui tam action against Novartis Pharmaceuticals Corporation (NPC) in the United States District Court (USDC) for the SDNY involving several of NPC’s cardiovascular medications. The suit is related to a previously disclosed 2011 investigation of the United States Attorney’s Office (USAO) for the SDNY relating to marketing practices, including the remuneration of healthcare providers, in connection with three NPC products (Lotrel, Starlix and Valturna). The complaint, as subsequently amended, asserts federal False Claims Act and common law claims with respect to speaker programs for NPC’s cardiovascular medications allegedly serving as mechanisms to provide kickbacks to healthcare professionals. It seeks unspecified damages, which according to the complaint are “substantial”, including treble damages and maximum civil penalties per claim, as well as disgorgement of Novartis profits from the alleged unlawful conduct. In August 2013, New York State filed a civil complaint in intervention asserting similar claims. Neither government complaint in intervention adopted the individual relator’s claims with respect to off-label promotion of Valturna, which were subsequently dismissed with prejudice by the court. NPC vigorously contests the SDNY, New York State and individual claims, both as to alleged liability and amount of damages and penalties.
SDNY specialty pharmacies investigation and litigation
In April 2013, the US government filed a civil complaint in intervention to a qui tam action against NPC in the USDC for the SDNY. The suit is related to a previously disclosed 2012 investigation of the USAO for the SDNY into NPC’s interactions with certain specialty pharmacies concerning in particular Myfortic, Exjade, Gleevec, Tasigna and TOBI. The complaint, as subsequently amended, asserts federal False Claims Act and state law claims related to alleged unlawful contractual discounts and rebates to specialty pharmacies in connection with Myfortic, and alleged unlawful contractual discounts, rebates and patient referrals to one specialty pharmacy in connection with Exjade. The US government seeks unspecified damages, which according to the complaint are “substantial”, including treble damages and maximum civil penalties per claim. In January 2014, eleven states filed three complaints in intervention asserting similar claims related to Exjade; and the qui tam relator served on NPC an amended complaint also asserting similar claims with respect to Myfortic and Exjade, as well as claims involving Tasigna, Gleevec and TOBI that the federal and various state governments declined to pursue. NPC vigorously contests all government and relator claims, both as to alleged liability and amount of damages and penalties.
District of New Jersey (DNJ) investigation
In late September 2014, Alcon Laboratories, Inc. (ALI) received a subpoena from the USAO for the DNJ relating to an investigation of Alcon sales practices. ALI is cooperating with this investigation.
New York state investigation
In November 2014, ALI received a civil subpoena from the New York state attorney general relating to an investigation into a unilateral pricing policy program. ALI is at the outset of assessing the facts and is cooperating with this investigation.
50
In 2013, the Italian Competition Authority (ICA) opened an investigation to assess whether Novartis Farma S.p.A., Novartis AG, F. Hoffmann-La Roche AG, Genentech Inc. and Roche S.p.A. colluded to artificially differentiate Avastin® and Lucentis in order to avoid the erosion of the sales of Lucentis by off-label Avastin® with the aim of preserving the market position of Lucentis in Italy. In March 2014, the ICA imposed a fine equivalent to USD 125 million on Novartis AG and Novartis Farma S.p.A. and a fine on F. Hoffmann-La Roche AG and Roche S.p.A. equivalent to USD 122 million. Novartis appealed the ICA decision and, as required by Italian law, has paid the ICA fine, subject to the right to later claim recoupment. In December 2014, the Tribunale amministrativo regionale (TAR) del Lazio published a decision rejecting all appeals. Novartis intends to appeal the decision of the TAR Lazio. In October 2014, Novartis also appealed the resolution of the Italian Medicines Agency to include Avastin® in a list of drugs to be reimbursed off-label. The Italian Ministry of Health (MoH) has indicated in a letter that it intended to seek a total equivalent of approximately USD 1.4 billion in damages from Novartis and Roche entities based on the above allegations, and the Lombardia region has sent a payment request equivalent to approximately USD 71 million. Novartis vigorously contests the MoH and Lombardia claims.
The French Competition Authority carried out an inspection in April 2014 on the premises of Novartis Groupe France and Roche with respect to the French market for anti-vascular endothelial growth factor (VEGF) products indicated for the treatment of wet age-related macular degeneration.
Japan investigations
Novartis Pharma K.K. (NPKK) has completed a comprehensive investigation with external specialists launched in April 2013 which identified that two former employees of NPKK were not appropriately identified as NPKK employees in the trial publications for five post-registration investigator initiated trials (IITs) regarding valsartan. In October 2013, the Japanese Ministry of Health, Labor and Welfare (MHLW) published an interim report in which it required further actions, including investigations by the government into allegations of exaggerated advertising. None of the trials/publications were used for registration purposes. In July 2014, the Tokyo District Public Prosecutor Office indicted a former NPKK employee, and also NPKK under the dual liability concept in Japanese law, in two counts for alleged manipulation of data in sub-analysis publications of the Kyoto Heart Study regarding valsartan. The charges against NPKK are subject to a maximum total fine of JPY 4 million. Novartis is cooperating fully with the authorities.
Also in January 2014, allegations of inappropriate involvement of NPKK representatives in a nilotinib IIT being conducted by the University of Tokyo Hospital were raised in the media. In February 2014, NPKK established an External Investigation Committee (EIC) to clarify the actual involvement in the IIT as well as the root cause and provide a proposal for preventing recurrence. In March 2014, the EIC issued a final report finding various instances of improper conduct, including improper handling of confidential patient information, document destruction and failure to report adverse events. The MHLW issued a business improvement order in July 2014, following NPKK’s disclosure of its failure to report adverse events. Novartis is implementing a business improvement plan and has notified all competent health authorities worldwide about the adverse events reporting issue, and several have requested additional information and clarification from Novartis. In addition to taking remedial action, Novartis also conducted a comprehensive review of NPKK’s conduct and business practices related to IITs and the other above issues in Japan, and has released new global guidelines for IITs.
The MHLW plans to issue new guidelines governing the conduct of IITs in Japan, and it is in the process of determining any additional sanctions against NPKK for the above conduct which could potentially include a temporary suspension of certain business activities.
Italy investigations
In January 2014, the ICA opened an investigation to assess whether Novartis Farma S.p.A. and Italfarmaco S.p.A. colluded on the supply of octreotide acetate (Sandostatin LAR and Longastatina® LAR, respectively) to prevent competition in tenders issued by the regions of Emilia Romagna, Veneto and Lombardia.
In June 2014, the public prosecutor of Siena initiated a criminal investigation of Novartis Vaccines and Diagnostics S.r.l. with respect to allegations that the transfer price of the adjuvant MF59 was unlawfully marked up. The investigation concerns whether the Focetria and Fluad vaccines sold to the government
51
Product liability matters
Zometa/Aredia�product liability litigation
NPC is a defendant in approximately 525 remaining cases brought in US courts, in which plaintiffs claim to have experienced osteonecrosis of the jaw or atypical femur fracture after treatment with Zometa or Aredia, which are used to treat patients whose cancer has spread to the bones. From the outset of the litigation, approximately 332 cases have been dismissed on pre-trial summary judgment or other dismissal, of which 16 remain on appeal.
Through the end of the fourth quarter of 2014, judgment has been entered in favor of NPC in nine jury trials, seven of which are final, and plaintiffs have obtained one verdict outside the centralized proceedings and six verdicts in the centralized litigation. In the centralized proceedings, juries awarded compensatory damages (averaging approximately USD�0.7 million in each case), no punitive damages in four cases, and punitive damages (as capped by applicable state and federal laws) totaling approximately USD�1.8 million in the remaining two. Four of the verdicts in favor of plaintiffs in the centralized litigation are not final given remaining post-trial and appeal options in each. In the one plaintiff’s verdict outside the centralized proceedings, the jury awarded USD�2.65 million in compensatory damages and no punitive damages.
Further trials are scheduled. Individual case results, which can depend on the particular facts of a given case, may not necessarily be predictive for other cases. The cases are being vigorously defended.
Arbitration
Fanapt® arbitration: Concluded
In May 2014, Vanda Pharmaceuticals Inc. commenced an arbitration against Novartis Pharma AG relating to the licensing of Fanapt®. The case was resolved in the fourth quarter of 2014 for an amount that is not material to Novartis.
Other Matters
Average Wholesale Price (AWP) litigation
Claims have been brought by various US state governmental entities against various pharmaceutical companies, including certain Sandoz entities and NPC, alleging that they fraudulently overstated the AWP that is or has been used by payors, including state Medicaid agencies, to calculate reimbursements to healthcare providers. In the second quarter of 2014, Sandoz reached a settlement of the Illinois claims against it for USD 63 million. Further settlements have been obtained in the cases brought by the states of Kansas and Utah against NPC, each for amounts that are not material to Novartis. Actions brought by the states of Illinois, Mississippi, Utah and Wisconsin remain pending against one or more Novartis companies. At least one trial is scheduled for 2015. NPC is also a defendant in a putative class action brought by private payors in New Jersey. The cases are being vigorously defended.
Qui tam action
In 2006, NPC received a subpoena from the US government seeking certain information regarding the marketing and promotion of Xolair. The investigation, which was previously disclosed, was prompted by a qui tam complaint filed in the District of Massachusetts (D. Mass.) in 2006, asserting various federal False Claims Act and state claims relating to certain alleged improper marketing practices involving Xolair. In addition to the 2006 suit, relator complaints were filed in D. Mass. in 2010 and 2012 against various Novartis, Genentech and Roche entities, containing allegations similar to those in the 2006 complaint. In 2011, the US and various state governments declined to intervene in the relators’ actions, and closed the investigation. In June 2014, the relator in the 2010 action voluntarily dismissed his claims in that complaint with prejudice; the US and various states subsequently consented to the dismissal. The relator complaints in combination claim more than USD 1.5 billion in alleged treble damages, civil penalties and disgorgement of profits. Novartis denies the allegations both as to the merits and the monetary claims and is vigorously contesting these actions.
Consumer class actions
Novartis companies have been the subject of various consumer lawsuits that are brought as proposed class actions but in which class certification has not been decided. For example, four putative class actions were brought in December 2013 and January 2014 against Novartis and its consumer health
52
Since November 2012, six putative consumer fraud class action litigations were commenced against Alcon (and in four cases Sandoz) in federal courts in the Southern Districts of Illinois (S.D. Ill.) and Florida and the Districts of Missouri, Massachusetts and New Jersey. They claim that Alcon’s, Sandoz’s and many other manufacturers defendants’ eye drop products were deceptively designed so that the drop dosage is more than necessary to be absorbed in the eye or there is too much solution in each bottle for the course of the treatment, leading to wastage and higher costs to patient consumers. Three cases remain pending in the S.D. Ill., D. Mass. and DNJ. Novartis is vigorously defending the remaining cases, both on the merits and with respect to class certification.
In addition to the matters described above, there have been other developments in the other legal matters described in Note 20 to the consolidated financial statements contained in our annual report for the year ended December 31, 2013. These do not significantly affect the assessment of management concerning the adequacy of the total provisions recorded for legal proceedings.
8. Subsequent event
Divestment of Animal Health business
On January 1, 2015, Novartis completed the divestment of its Animal Health division to Eli Lilly and Company, USA, for approximately USD 5.4 billion. This will result in a pre-tax gain of approximately USD 4.6 billion.
53
SUPPLEMENTARY INFORMATION (unaudited)
Non-IFRS disclosures
Core results
The Group’s core results – including core operating income, core net income and core earnings per share – exclude the amortization of intangible assets, impairment charges, expenses relating to the integration of acquisitions as well as other income and expense items that are, or are expected to accumulate within the year to be, over a USD 25 million threshold that management deems exceptional.
Novartis believes that investor understanding of the Group’s performance is enhanced by disclosing core measures of performance because, since they exclude these items which can vary significantly from year to year, the core measures enable better comparison across years. For this same reason, Novartis uses these core measures in addition to IFRS and other measures as important factors in assessing the Group’s performance.
The following are examples of how these core measures are utilized:
• In addition to monthly reports containing financial information prepared under International Financial Reporting Standards (IFRS), senior management receives a monthly analysis incorporating these core measures.
• Annual budgets are prepared that include targets for both IFRS and core measures.
Despite the use of these measures by management in setting goals and measuring the Group’s performance, these are non-IFRS measures that have no standardized meaning prescribed by IFRS. As a result, such measures have limits in usefulness to investors.
Because of their non-standardized definitions, the core measures (unlike IFRS measures) may not be comparable to the calculation of similar measures of other companies. These core measures are presented solely to permit investors to more fully understand how the Group’s management assesses underlying performance. These core measures are not, and should not be viewed as, a substitute for IFRS measures.
As an internal measure of Group performance, these core measures have limitations, and the performance management process is not solely restricted to these metrics. A limitation of the core measures is that they provide a view of the Group’s operations without including all events during a period, such as the effects of an acquisition or amortization of purchased intangible assets.
2013 results excluding Diagnostics unit
On January 9, 2014, Novartis completed the divestment to Grifols S.A. of our former blood transfusion diagnostics unit, which had been included in our former Vaccines and Diagnostics Division. Because the divestment occurred near the beginning of 2014, Novartis believes that investor understanding of the Group’s performance would be enhanced by disclosing a comparison of the Novartis 2014 results against 2013 results that exclude the results of the divested business, since it will assist investors in evaluating the Group’s performance on a more comparable basis from year to year. For this reason, management has used this comparison, in addition to IFRS and other measures, in its assessments of the Group’s performance.
Constant currencies
Changes in the relative values of non-US currencies to the US dollar can affect the Group’s financial results and financial position. To provide additional information that may be useful to investors, including changes in sales volume, we present information about our net sales and various values relating to operating and net income that are adjusted for such foreign currency effects.
Constant currency calculations have the goal of eliminating two exchange rate effects so that an estimate can be made of underlying changes in the consolidated income statement excluding the impact of fluctuations in exchanges rates:
54
• the impact of exchange rate movements on the major transactions of consolidated entities performed in currencies other than their functional currency.
We calculate constant currency measures by translating the current year’s foreign currency values of the sales and earnings into USD using the average exchange rates from the prior year and comparing them to the prior year values in USD.
We use these constant currency measures in evaluating the Group’s performance, since they may assist us in evaluating our ongoing performance from year to year. However, in performing our evaluation, we also consider equivalent measures of performance which are not affected by changes in the relative value of currencies.
Growth rate calculation
For ease of understanding, Novartis uses a sign convention for its growth rates such that a reduction in operating expenses or losses compared to the prior year is shown as a positive growth.
Net debt and free cash flow
Net debt and free cash flow are non-IFRS financial measures, which means they should not be interpreted as measures determined under IFRS. Net debt is presented as additional information because management believes it is a useful supplemental indicator of the Group’s ability to pay dividends, to meet financial commitments and to invest in new strategic opportunities, including strengthening its balance sheet. Free cash flow is presented as additional information because management believes it is a useful supplemental indicator of the Group’s ability to operate without reliance on additional borrowing or usage of existing cash. Free cash flow is a measure of the net cash generated that is available for debt repayment, investment in strategic opportunities and for returning to shareholders. Novartis uses free cash flow in internal comparisons of results from the Group’s divisions. Free cash flow of the divisions uses the same definition as for the Group. No tax or financial receipts or payments are included in the division calculations. The definition of free cash flow used by Novartis does not include amounts related to changes in investments in associated companies nor related to acquisitions or divestments of subsidiaries. Free cash flow is not intended to be a substitute measure for cash flow from operating activities as determined under IFRS.
55
| Pharmaceuticals | Alcon | Sandoz | Corporate continuing operations | Total continuing operations | Total discontinuing operations | Total | |||||||||||||||||||||||
|
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
Q4 2014 USD m |
Q4 2013 USD m |
||||||||||||||||
| IFRS Operating income | 1�611 | 2�013 | 365 | 172 | 290 | 276 | 85 | -128 | 2�351 | 2�333 | -1�179 | 40 | 1�172 | 2�373 | |||||||||||||||
| Adjustment for divested blood transfusion diagnostics unit | -95 | -95 | |||||||||||||||||||||||||||
| Operating income excl. Diagnostics | 1�611 | 2�013 | 365 | 172 | 290 | 276 | 85 | -128 | 2�351 | 2�333 | -1�179 | -55 | 1�172 | 2�278 | |||||||||||||||
| Amortization of intangible assets | 67 | 70 | 522 | 517 | 96 | 105 | 1 | 686 | 692 | 57 | 686 | 749 | |||||||||||||||||
| Impairments | |||||||||||||||||||||||||||||
|
Intangible assets
|
155 | 19 | 12 | 167 | 19 | 405 | 572 | 19 | |||||||||||||||||||||
|
Property, plant & equipment related to the Group-wide rationalization of manufacturing sites
|
2 | -1 | 1 | 1 | 2 | ||||||||||||||||||||||||
|
Other property, plant & equipment
|
-6 | 53 | 5 | 1 | 1 | 17 | 71 | 737 | 1 | 737 | 72 | ||||||||||||||||||
|
Financial assets
|
6 | 14 | 1 | 43 | 6 | 50 | 20 | 50 | 20 | ||||||||||||||||||||
| Total impairment charges | 157 | 86 | -1 | 18 | 1 | 44 | 23 | 218 | 110 | 1�143 | 1 | 1�361 | 111 | ||||||||||||||||
| Acquisition or divestment related items | |||||||||||||||||||||||||||||
|
- Income
|
4 | 4 | |||||||||||||||||||||||||||
|
- Expense
|
26 | 121 | 26 | 121 | 196 | 222 | 121 | ||||||||||||||||||||||
| Total acquisition or divestment related items, net | 26 | 121 | 26 | 121 | 200 | 226 | 121 | ||||||||||||||||||||||
| Other exceptional items | |||||||||||||||||||||||||||||
|
Exceptional divestment gains
|
-34 | -125 | -248 | -282 | -125 | -282 | -125 | ||||||||||||||||||||||
|
Restructuring items
|
|||||||||||||||||||||||||||||
|
- Income
|
-13 | -28 | -11 | -24 | -28 | 1 | -23 | -28 | |||||||||||||||||||||
|
- Expense
|
220 | 85 | 21 | 41 | 12 | 253 | 126 | 2 | -3 | 255 | 123 | ||||||||||||||||||
|
Legal-related items
|
|||||||||||||||||||||||||||||
|
- Expense
|
5 | -10 | 30 | 30 | -5 | 30 | -5 | ||||||||||||||||||||||
|
Additional exceptional income
|
-59 | -34 | -29 | -44 | -4 | -1 | -88 | -83 | -81 | 1 | -169 | -82 | |||||||||||||||||
|
Additional exceptional expense
|
2 | 61 | 28 | 44 | 5 | 29 | 39 | 59 | 149 | 7 | 2 | 66 | 151 | ||||||||||||||||
| Total other exceptional items | 116 | -36 | 9 | 41 | 12 | -9 | -189 | 38 | -52 | 34 | -71 | -123 | 34 | ||||||||||||||||
| Total adjustments | 366 | 120 | 530 | 679 | 126 | 97 | -144 | 61 | 878 | 957 | 1�272 | 58 | 2�150 | 1�015 | |||||||||||||||
| Core operating income | 1�977 | 2�133 | 895 | 851 | 416 | 373 | -59 | -67 | 3�229 | 3�290 | 93 | 3 | 3�322 | 3�293 | |||||||||||||||
| as % of net sales | 25.2% | 25.6% | 33.1% | 32.1% | 16.6% | 15.5% | 24.7% | 24.6% | 6.0% | 0.2% | 22.7% | 22.1% | |||||||||||||||||
| Income from associated companies | 1 | 579 | 155 | 580 | 155 | -1 | -1 | 579 | 154 | ||||||||||||||||||||
| Core adjustments to income from associated companies, net of tax | -370 | 44 | -370 | 44 | -370 | 44 | |||||||||||||||||||||||
| Interest expense | -188 | -163 | -188 | -163 | |||||||||||||||||||||||||
| Other financial income and expense | 13 | -42 | 13 | -42 | |||||||||||||||||||||||||
| Taxes (adjusted for above items) | -407 | -418 | -35 | 24 | -442 | -394 | |||||||||||||||||||||||
| Core net income | 2�857 | 2�866 | 57 | 26 | 2�914 | 2�892 | |||||||||||||||||||||||
| Core net income attributable to shareholders | 2�860 | 2�836 | 58 | 27 | 2�918 | 2�863 | |||||||||||||||||||||||
| Core EPS (USD) | 1.19 | 1.17 | 0.02 | 0.01 | 1.21 | 1.18 | |||||||||||||||||||||||
|
�
|
|||||||||||||||||||||||||||||
56
| Pharmaceuticals | Alcon | Sandoz | Corporate continuing operations | Total continuing operations | Total discontinuing operations | Total | |||||||||||||||||||||||
|
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
||||||||||||||||
| IFRS Operating income | 8�471 | 9�376 | 1�597 | 1�232 | 1�088 | 1�028 | -67 | -653 | 11�089 | 10�983 | -353 | -73 | 10�736 | 10�910 | |||||||||||||||
| Adjustment for divested blood transfusion diagnostics unit | -239 | -239 | |||||||||||||||||||||||||||
| Operating income excl. Diagnostics | 8�471 | 9�376 | 1�597 | 1�232 | 1�088 | 1�028 | -67 | -653 | 11�089 | 10�983 | -353 | -312 | 10�736 | 10�671 | |||||||||||||||
| Amortization of intangible assets | 276 | 278 | 2�064 | 1�989 | 400 | 409 | 3 | 4 | 2�743 | 2�680 | 73 | 220 | 2�816 | 2�900 | |||||||||||||||
| Impairments | |||||||||||||||||||||||||||||
|
Intangible assets
|
231 | 29 | 7 | 57 | 39 | 20 | 277 | 106 | 405 | 8 | 682 | 114 | |||||||||||||||||
|
Property, plant & equipment related to the Group-wide rationalization of manufacturing sites
|
23 | 1 | 23 | 1 | -1 | 33 | 22 | 34 | |||||||||||||||||||||
|
Other property, plant & equipment
|
-8 | 28 | -1 | 4 | 7 | -3 | 23 | 17 | 21 | 46 | 737 | 758 | 46 | ||||||||||||||||
|
Financial assets
|
20 | 16 | 1 | 91 | 41 | 112 | 57 | 8 | 112 | 65 | |||||||||||||||||||
| Total impairment charges | 266 | 74 | 6 | 61 | 47 | 17 | 114 | 58 | 433 | 210 | 1�141 | 49 | 1�574 | 259 | |||||||||||||||
| Acquisition or divestment related items | |||||||||||||||||||||||||||||
|
- Income
|
-876 | -876 | |||||||||||||||||||||||||||
|
- Expense
|
33 | 330 | 1 | 33 | 331 | 196 | 229 | 331 | |||||||||||||||||||||
| Total acquisition or divestment related items, net | 33 | 330 | 1 | 33 | 331 | -680 | -647 | 331 | |||||||||||||||||||||
| Other exceptional items | |||||||||||||||||||||||||||||
|
Exceptional divestment gains
|
-237 | -313 | -294 | -531 | -313 | -531 | -313 | ||||||||||||||||||||||
|
Restructuring items
|
|||||||||||||||||||||||||||||
|
- Income
|
-56 | -40 | -24 | -3 | -83 | -40 | -7 | -90 | -40 | ||||||||||||||||||||
|
- Expense
|
632 | 122 | 95 | 77 | 21 | 2 | 1 | 749 | 201 | 28 | 25 | 777 | 226 | ||||||||||||||||
|
Legal-related items
|
|||||||||||||||||||||||||||||
|
- Income
|
-2 | -2 | |||||||||||||||||||||||||||
|
- Expense
|
125 | 33 | 85 | 30 | 155 | 118 | 155 | 118 | |||||||||||||||||||||
|
Additional exceptional income
|
-158 | -70 | -29 | -56 | -4 | -315 | -75 | -502 | -205 | -81 | -583 | -205 | |||||||||||||||||
|
Additional exceptional expense
|
162 | 63 | 102 | 61 | 18 | 4 | 105 | 114 | 387 | 242 | 24 | 2 | 411 | 244 | |||||||||||||||
| Total other exceptional items | 468 | -205 | 144 | 82 | 36 | 87 | -473 | 39 | 175 | 3 | -38 | 27 | 137 | 30 | |||||||||||||||
| Total adjustments | 1�043 | 147 | 2�214 | 2�462 | 483 | 513 | -356 | 102 | 3�384 | 3�224 | 496 | 296 | 3�880 | 3�520 | |||||||||||||||
| Core operating income | 9�514 | 9�523 | 3�811 | 3�694 | 1�571 | 1�541 | -423 | -551 | 14�473 | 14�207 | 143 | -16 | 14�616 | 14�191 | |||||||||||||||
| as % of net sales | 29.9% | 29.6% | 35.2% | 35.2% | 16.4% | 16.8% | 27.7% | 27.4% | 2.5% | -0.3% | 25.2% | 24.7% | |||||||||||||||||
| Income from associated companies | 812 | 4 | 2 | 1�102 | 597 | 1�918 | 599 | 2 | 1 | 1�920 | 600 | ||||||||||||||||||
| Core adjustments to income from associated companies, net of tax | -812 | -163 | 277 | -975 | 277 | -975 | 277 | ||||||||||||||||||||||
| Interest expense | -704 | -683 | -704 | -683 | |||||||||||||||||||||||||
| Other financial income and expense1 | -31 | -48 | -31 | -48 | |||||||||||||||||||||||||
| Taxes (adjusted for above items) | -2�028 | -2�057 | -43 | 71 | -2�071 | -1�986 | |||||||||||||||||||||||
| Core net income | 12�653 | 12�295 | 102 | 56 | 12�755 | 12�351 | |||||||||||||||||||||||
| Core net income attributable to shareholders | 12�580 | 12�175 | 105 | 59 | 12�685 | 12�234 | |||||||||||||||||||||||
| Core EPS (USD) | 5.19 | 4.99 | 0.04 | 0.02 | 5.23 | 5.01 | |||||||||||||||||||||||
|
1�2013 adjusted for USD 44 million devaluation loss.
|
|||||||||||||||||||||||||||||
57
|
Q4 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges 3 |
Other exceptional items 4 |
Q4 2014 Core results |
Q4 2013 Core results excluding Diagnostics 5 |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 9�504 | 672 | 254 | 47 | 10�477 | 10�671 | |||||||||
| Operating income | 1�172 | 686 | 1�361 | 226 | -123 | 3�322 | 3�293 | ||||||||
| Income before taxes | 1�576 | 736 | 1�362 | 226 | -544 | 3�356 | 3�286 | ||||||||
| Taxes6 | -89 | -442 | -394 | ||||||||||||
| Net income | 1�487 | 2�914 | 2�892 | ||||||||||||
| EPS (USD)7 | 0.62 | 1.21 | 1.18 | ||||||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -5�369 | 672 | 254 | 47 | -4�396 | -4�462 | |||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Marketing & Sales | -3�676 | 7 | -3�669 | -3�913 | |||||||||||
| Research & Development | -2�753 | 13 | 215 | -6 | -2�531 | -2�601 | |||||||||
| General & Administration | -844 | 23 | -821 | -807 | |||||||||||
| Other income | 689 | -9 | 4 | -476 | 208 | 315 | |||||||||
| Other expense | -1�748 | 1 | 901 | 222 | 282 | -342 | -372 | ||||||||
| The following are adjustments to arrive at Core Income before taxes | |||||||||||||||
| Income from associated companies | 579 | 50 | 1 | -421 | 209 | 198 | |||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms; Other expense includes amortization of intangible assets; Income from associated companies includes USD 50 million for the Novartis share of the estimated Roche core items.
|
|||||||||||||||
|
2�Impairments: Cost of goods sold, Research & Development, Other income and Other expense include principally net impairment charges or reversals related to intangible assets, property, plant and equipment and financial assets; Cost of goods sold and Other expense include the USD 1.1 billion impairment charge as a result of the proposed sale of the influenza vaccines business; Other expense also includes an additional impairment charge incurred in Corporate, for an in-process project which is pending divestment as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
|
3�Acquisition or divestment related items, including restructuring and integration charges: Other income includes an adjustment to the gain on the disposal of the blood transfusion diagnostics unit on January 9, 2014; Other expense includes costs related to the planned acquisition of GSK oncology assets as well as professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
4�Other exceptional items: Cost of goods sold includes charges for the Group-wide rationalization of manufacturing sites; Marketing & Sales, Research & Development and General & Administration include charges for transforming IT and finance processes; Other income includes manufacturing sites rationalization gains, product related divestment gains and gains in the Novartis Venture Fund, and the impact from a post-retirement medical plan amendment; Other expense also includes restructuring provision charges, charges for transforming IT, and a write-off of a receivable as a result of the proposed portfolio transformation transactions; Income from associated companies includes the gain from the divestment of the Lohmann shareholding.
|
|||||||||||||||
|
5�2013 figures exclude the blood transfusion diagnostics unit which was divested on January 9, 2014.
|
|||||||||||||||
|
6�Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on exceptional items although this is not the case for items arising from criminal settlements in certain jurisdictions. Adjustments related to income from associated companies are recorded net of any related tax effect. Due to these factors and the differing effective tax rates in the various jurisdictions, the tax on the total adjustments of USD 1.8 billion to arrive at the core results before tax amounts to USD 353 million. The average tax rate on the adjustments is 19.8% due to the adjustment required in the quarter by applying the estimated full year tax charge to the year-to-date pre-tax income of the period.
|
|||||||||||||||
|
7�Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
|
|||||||||||||||
58
|
FY 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges 3 |
Other exceptional items 4 |
FY 2014 Core results |
FY 2013 Core results excluding Diagnostics 5 |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 39�175 | 2�757 | 281 | -120 | 42�093 | 41�763 | |||||||||
| Operating income | 10�736 | 2�816 | 1�574 | -647 | 137 | 14�616 | 14�191 | ||||||||
| Income before taxes | 11�921 | 3�073 | 1�575 | -647 | -1�096 | 14�826 | 14�337 | ||||||||
| Taxes6 | -1�641 | -2�071 | -1�986 | ||||||||||||
| Net income | 10�280 | 12�755 | 12�351 | ||||||||||||
| EPS (USD)7 | 4.21 | 5.23 | 5.01 | ||||||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Other revenues | 1�280 | -302 | 978 | 699 | |||||||||||
| Cost of goods sold | -20�101 | 2�757 | 281 | 182 | -16�881 | -16�291 | |||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Marketing & Sales | -14�189 | 22 | -14�167 | -14�477 | |||||||||||
| Research & Development | -9�943 | 56 | 298 | 17 | -9�572 | -9�613 | |||||||||
| General & Administration | -3�047 | 64 | -2�983 | -3�014 | |||||||||||
| Other income | 2�380 | -16 | -876 | -902 | 586 | 799 | |||||||||
| Other expense | -3�640 | 3 | 1�011 | 229 | 1�056 | -1�341 | -1�267 | ||||||||
| The following are adjustments to arrive at Core Income before taxes | |||||||||||||||
| Income from associated companies | 1�920 | 257 | 1 | -1�233 | 945 | 877 | |||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms; Other expense includes amortization of intangible assets; Income from associated companies includes USD 257 million for the Novartis share of the estimated Roche core items.
|
|||||||||||||||
|
2�Impairments: Cost of goods sold, Research & Development, Other income and Other expense consist principally of net impairment charges or reversals related to intangible assets, property, plant and equipment and financial assets; Cost of goods sold and Other expense also include the USD 1.1 billion impairment charge as a result of the proposed sale of the influenza vaccines business; Other expense also includes an additional impairment charge incurred in Corporate, for an in-process project which is pending divestment as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
|
3�Acquisition or divestment related items, including restructuring and integration charges: Other income includes the gain on the disposal of the blood transfusion diagnostics unit on January 9, 2014; Other expense includes costs related to the planned acquisition of GSK oncology assets as well as professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
4�Other exceptional items: Other revenues includes an amount for a commercial settlement; Cost of goods sold includes charges for the Group-wide rationalization of manufacturing sites; Marketing & Sales, Research & Development and General & Administration include charges for transforming IT and finance processes; Other income includes product related divestment gains and gains in the Novartis Venture Fund, an insurance recovery net of a deferred amount, a partial reversal of a legal expense provision, a reduction in restructuring provisions, and the impact from a post-retirement medical plan amendment; Other expense includes restructuring provision charges, charges for transforming IT and finance processes, an expense related to Lucentis in Italy, the expense of USD 204 million related to the advancement of the timing of recording the US Healthcare Fee liability as a result of final regulations, and a write-off of a receivable as a result of the proposed portfolio transformation transactions; Income from associated companies includes gains from the divestment of Idenix and Lohmann shareholdings.
|
|||||||||||||||
|
5�2013 figures exclude the blood transfusion diagnostics unit which was divested on January 9, 2014.
|
|||||||||||||||
|
6�Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on exceptional items although this is not the case for items arising from criminal settlements in certain jurisdictions. Adjustments related to income from associated companies are recorded net of any related tax effect. Due to these factors and the differing effective tax rates in the various jurisdictions, the tax on the total adjustments of USD 2.9 billion to arrive at the core results before tax amounts to USD 430 million. The average tax rate on the adjustments is 14.8 % since the estimated full year tax charge has been applied to the pre-tax income of the period.
|
|||||||||||||||
|
7�Earnings per share (EPS) is calculated on the amount of net income attributable to shareholders of Novartis AG.
|
|||||||||||||||
59
|
Q4 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges 3 |
Other exceptional items 4 |
Q4 2014 Core results |
Q4 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 6�383 | 59 | -58 | 31 | 6�415 | 6�773 | |||||||||
| Operating income | 1�611 | 67 | 157 | 26 | 116 | 1�977 | 2�133 | ||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -1�709 | 59 | -58 | 31 | -1�677 | -1�712 | |||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Marketing & Sales | -2�157 | 2 | -2�155 | -2�330 | |||||||||||
| Research & Development | -2�073 | 8 | 213 | -16 | -1�868 | -1�958 | |||||||||
| Other income | 215 | -10 | -108 | 97 | 118 | ||||||||||
| Other expense | -463 | 12 | 26 | 207 | -218 | -198 | |||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
|
|||||||||||||||
|
2�Impairments: Cost of good sold includes partial reversal of previously impaired production assets, partly offset by the impairment of intangible assets related to a marketed product; Research & Development includes impairment charges for in process projects and termination of collaboration and license agreements; Other income relates to impairment reversals of property, plant and equipment; Other expense includes impairment charges related to property, plant and equipment and financial assets.
|
|||||||||||||||
|
3�Acquisition or divestment related items, including restructuring and integration charges: Other expense includes costs related to the planned acquisition of GSK oncology assets.
|
|||||||||||||||
|
4�Other exceptional items: Cost of goods sold and Research & Development include net restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes gains related to the rationalization of manufacturing sites, the impact from a post-retirement medical plan amendment, as well as additional gains from divestments announced in prior periods; Other expense includes mostly restructuring charges.
|
|||||||||||||||
60
|
FY 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges 3 |
Other exceptional items 4 |
FY 2014 Core results |
FY 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 25�793 | 238 | -58 | 127 | 26�100 | 26�492 | |||||||||
| Operating income | 8�471 | 276 | 266 | 33 | 468 | 9�514 | 9�523 | ||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -6�889 | 238 | -58 | 127 | -6�582 | -6�421 | |||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Marketing & Sales | -8�178 | 2 | -8�176 | -8�487 | |||||||||||
| Research & Development | -7�331 | 38 | 289 | 7 | -6�997 | -7�161 | |||||||||
| General & Administration | -1�009 | 1 | -1�008 | -1�051 | |||||||||||
| Other income | 734 | -13 | -451 | 270 | 263 | ||||||||||
| Other expense | -1�538 | 48 | 33 | 782 | -675 | -533 | |||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
|
|||||||||||||||
|
2�Impairments: Cost of good sold includes partial reversal of previously impaired production assets, partly offset by the impairment of intangible assets related to a marketed product; Research & Development includes impairment charges for in process projects and termination of collaboration and license agreements; Other income relates to impairment reversals of property, plant and equipment; Other expense includes impairment charges related to property, plant and equipment and financial assets.
|
|||||||||||||||
|
3�Acquisition or divestment related items, including restructuring and integration charges: Other expense includes costs related to the planned acquisition of GSK oncology assets.
|
|||||||||||||||
|
4�Other exceptional items: Cost of goods sold, Research & Development and Marketing & Sales include net restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes an insurance recovery from Corporate related to exchange risks, gains related to the rationalization of manufacturing sites, the impact from a post-retirement medical plan amendment, as well as additional gains from divestments announced in prior periods; Other expense include restructuring charges, an expense related to Lucentis in Italy and an expense of USD 157 million related to the advancement of the timing of recording the US Healthcare Fee liability as a result of final regulations.
|
|||||||||||||||
|
�
|
|||||||||||||||
61
|
Q4 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges |
Other exceptional items 3 |
Q4 2014 Core results |
Q4 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 1�404 | 517 | 3 | 1�924 | 1�880 | ||||||||||
| Operating income | 365 | 522 | -1 | 9 | 895 | 851 | |||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -1�320 | 517 | 3 | -800 | -792 | ||||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Marketing & Sales | -641 | 5 | -636 | -648 | |||||||||||
| Research & Development | -247 | 5 | 10 | -232 | -236 | ||||||||||
| General & Administration | -162 | 14 | -148 | -142 | |||||||||||
| Other income | 42 | -39 | 3 | 11 | |||||||||||
| Other expense | -31 | -1 | 16 | -16 | -14 | ||||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
|
|||||||||||||||
|
2�Impairments: Other expense includes the reversal of impairment charges related to property, plant and equipment.
|
|||||||||||||||
|
3�Other exceptional items: Cost of goods sold and Other expense include net restructuring charges related to the Group-wide rationalization of manufacturing sites; Marketing & Sales and General & Administration include charges for transforming IT and finance processes; Research & Development includes a net increase of contingent consideration liabilities related to acquisitions; Other income includes the reversal of restructuring charges related to the Group-wide rationalization of manufacturing sites and the impact from a post-retirement medical plan amendment.
|
|||||||||||||||
|
�
|
|||||||||||||||
|
�
|
|||||||||||||||
62
|
FY 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges |
Other exceptional items 3 |
FY 2014 Core results |
FY 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 5�717 | 2�056 | 26 | 7�799 | 7�665 | ||||||||||
| Operating income | 1�597 | 2�064 | 6 | 144 | 3�811 | 3�694 | |||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -5�193 | 2�056 | 26 | -3�111 | -2�908 | ||||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Marketing & Sales | -2�474 | 20 | -2�454 | -2�452 | |||||||||||
| Research & Development | -928 | 8 | 7 | 10 | -903 | -939 | |||||||||
| General & Administration | -613 | 45 | -568 | -564 | |||||||||||
| Other income | 79 | -1 | -52 | 26 | 39 | ||||||||||
| Other expense | -184 | 95 | -89 | -55 | |||||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
|
|||||||||||||||
|
2�Impairments: Research & Development includes impairment charges for in process projects; Other income includes a reversal of impairment charges related to property, plant and equipment.
|
|||||||||||||||
|
3�Other exceptional items: Cost of goods sold and Other expense include net restructuring charges related to the Group-wide rationalization of manufacturing sites; Marketing & Sales and General & Administration include charges for transforming IT and finance processes; Research & Development includes a net increase of contingent consideration liabilities related to acquisitions; Other income includes the reversal of restructuring charges related to the Group-wide rationalization of manufacturing sites, as well as the impact from a post-retirement medical plan amendment; Other expense also includes an expense of USD 29 million related to the advancement of the timing of recording the US Healthcare Fee liability as a result of final regulations.
|
|||||||||||||||
|
�
|
|||||||||||||||
63
|
Q4 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges |
Other exceptional items 3 |
Q4 2014 Core results |
Q4 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 1�058 | 96 | 10 | 5 | 1�169 | 1�119 | |||||||||
| Operating income | 290 | 96 | 18 | 12 | 416 | 373 | |||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -1�527 | 96 | 10 | 5 | -1�416 | -1�375 | |||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Research & Development | -217 | 2 | -215 | -208 | |||||||||||
| Other expense | -55 | 6 | 7 | -42 | -29 | ||||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets.
|
|||||||||||||||
|
2�Impairments: Cost of goods sold and Research & Development include charges related to impairment of intangible assets; Other expense includes impairment charges related to property, plant and equipment and financial assets.
|
|||||||||||||||
|
3�Other exceptional items: Cost of goods sold and Other expense relates to restructuring charges.
|
|||||||||||||||
|
�
|
|||||||||||||||
64
|
FY 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges |
Other exceptional items 3 |
FY 2014 Core results |
FY 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 4�109 | 398 | 37 | 10 | 4�554 | 4�424 | |||||||||
| Operating income | 1�088 | 400 | 47 | 36 | 1�571 | 1�541 | |||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -5�751 | 398 | 37 | 10 | -5�306 | -5�047 | |||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Research & Development | -827 | 2 | 2 | -823 | -785 | ||||||||||
| Other income | 97 | -1 | -3 | 93 | 100 | ||||||||||
| Other expense | -190 | 9 | 29 | -152 | -152 | ||||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets; Research & Development includes the recurring amortization of acquired rights for technology platforms.
|
|||||||||||||||
|
2�Impairments: Cost of goods sold and Research & Development include charges related to impairment of intangible assets; Other income includes a reversal of impairment charges related to property, plant and equipment; Other expense includes impairment charges related to property, plant and equipment and financial assets.
|
|||||||||||||||
|
3�Other exceptional items: Cost of goods sold and Other expense include net restructuring charges; Other income includes the reversal of restructuring charges; Other expense also includes an expense of USD 18 million related to the advancement of the timing of recording the US Healthcare Fee liability as a result of final regulations.
|
|||||||||||||||
|
�
|
|||||||||||||||
65
|
Q4 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges |
Other exceptional items 3 |
Q4 2014 Core results |
Q4 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 93 | 93 | 110 | ||||||||||||
| Operating loss | 85 | 1 | 44 | -189 | -59 | -67 | |||||||||
| The following are adjustments to arrive at Core Operating Loss | |||||||||||||||
| General & Administration | -178 | 9 | -169 | -169 | |||||||||||
| Other income | 312 | -248 | 64 | 104 | |||||||||||
| Other expense | -142 | 1 | 44 | 50 | -47 | -112 | |||||||||
|
1�Amortization of intangible assets: Other expense includes amortization of intangible assets.
|
|||||||||||||||
|
2�Impairments: Other expense includes impairment charges related to property, plant and equipment and financial assets.
|
|||||||||||||||
|
3�Other exceptional items: General & Administration includes expenses related to setup costs for Novartis Business Services; Other income relates to gains in the Novartis Venture Fund; Other expense includes charges for transforming IT and finance processes, as well as a provision for a legal settlement.
|
|||||||||||||||
|
�
|
|||||||||||||||
|
�
|
|||||||||||||||
66
|
FY 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges |
Other exceptional items 3 |
FY 2014 Core results |
FY 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 670 | -302 | 368 | 211 | |||||||||||
| Operating loss | -67 | 3 | 114 | -473 | -423 | -551 | |||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Other revenues | 540 | -302 | 238 | 84 | |||||||||||
| The following are adjustments to arrive at Core Operating Loss | |||||||||||||||
| General & Administration | -618 | 18 | -600 | -589 | |||||||||||
| Other income | 481 | -307 | 174 | 246 | |||||||||||
| Other expense | -600 | 3 | 114 | 118 | -365 | -419 | |||||||||
|
1�Amortization of intangible assets: Other expense includes amortization of intangible assets.
|
|||||||||||||||
|
2�Impairments: Other expense includes impairment charges related to property, plant and equipment and financial assets.
|
|||||||||||||||
|
3�Other exceptional items: Other revenues includes an amount for a commercial settlement; General & Administration includes expenses related to setup costs for Novartis Business Services; Other income includes an insurance recovery transferred to Pharmaceuticals net of a deferred amount and gains in the Novartis Venture Fund; Other expense includes charges for transforming IT and finance processes, as well as a provision for a legal settlement.
|
|||||||||||||||
|
�
|
|||||||||||||||
|
�
|
|||||||||||||||
|
�
|
|||||||||||||||
67
|
Q4 2014 IFRS results |
Amortization of intangible assets |
Impairments 1 |
Acquisition or divestment related items, including restructuring and integration charges 2 |
Other exceptional items 3 |
Q4 2014 Core results |
Q4 2013 Core results excluding Diagnostics 4 |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 566 | 302 | 8 | 876 | 789 | ||||||||||
| Operating income | -1�179 | 1�143 | 200 | -71 | 93 | 3 | |||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -1�022 | 302 | 8 | -712 | -779 | ||||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Other income | 91 | 1 | 4 | -81 | 15 | 45 | |||||||||
| Other expense | -1�065 | 840 | 196 | 2 | -27 | -23 | |||||||||
|
1�Impairments: Cost of goods sold and Other expense include the USD 1.1 billion impairment charge as a result of the proposed sale of the influenza vaccines business; Other income includes a revision to a reversal of an impairment charge for property, plant and equipment; Other expense relates to an additional impairment charge incurred in Corporate, for an in-process project which is pending divestment as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
|
2�Acquisition or divestment related items, including restructuring and integration charges: Other income includes an adjustment to the gain on the disposal of the blood transfusion diagnostics unit on January 9, 2014; Other expense includes professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
3�Other exceptional items: Cost of goods sold and Other expense include net restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes the reversal of restructuring charges related to the Group-wide rationalization of manufacturing sites, and the gain on the sale of a divested product, which was sold as a result of the proposed portfolio transformation transactions; Other expense includes the write-off of a receivable as a result of the proposed portfolio transformation transactions, partially offset by prior period professional service fees which have been reclassed as acquisition related items.
|
|||||||||||||||
|
4�2013 figures exclude the blood transfusion diagnostics unit which was divested on January 9, 2014.
|
|||||||||||||||
|
�
|
|||||||||||||||
68
|
FY 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges 3 |
Other exceptional items 4 |
FY 2014 Core results |
FY 2013 Core results excluding Diagnostics 5 |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 2�886 | 65 | 302 | 19 | 3�272 | 2�971 | |||||||||
| Operating income | -353 | 73 | 1�141 | -680 | -38 | 143 | -16 | ||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -3�073 | 65 | 302 | 19 | -2�687 | -2�650 | |||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Research & Development | -857 | 8 | -849 | -728 | |||||||||||
| Other income | 1�007 | -1 | -876 | -89 | 41 | 163 | |||||||||
| Other expense | -1�146 | 840 | 196 | 32 | -78 | -120 | |||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets up to the portfolio transformation annoucement date; Research & Development includes the recurring amortization of acquired rights for technology platforms up to the portfolio transformation annoucement date.
|
|||||||||||||||
|
2�Impairments: Cost of goods sold and Other expense include the USD 1.1 billion impairment charge as a result of the proposed sale of the influenza vaccines business; Other income includes a reduction of an impairment charge for property, plant and equipment; Other expense relates to an additional impairment charge in Corporate, for an in-process project which is pending divestment as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
|
3�Acquisition or divestment related items, including restructuring and integration charges: Other income includes the gain on the disposal of the blood transfusion diagnostics unit on January 9, 2014; Other expense includes professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
4�Other exceptional items: Cost of goods sold and Other expense include restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes the gain on the sale of a divested product, which was sold as a result of the proposed portfolio transformation transaction, the reversal of restructuring charges related to the Group-wide rationalization of manufacturing sites, the partial reversal of a legal expense provision, and the impact from a post-retirement medical plan amendment; Other expense also includes the write-off of a receivable as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
|
5�2013 figures exclude the blood transfusion diagnostics unit which was divested on January 9, 2014.
|
|||||||||||||||
|
�
|
|||||||||||||||
69
|
Q4 2014 IFRS results |
Amortization of intangible assets |
Impairments 1 |
Acquisition or divestment related items, including restructuring and integration charges 2 |
Other exceptional items 3 |
Q4 2014 Core results |
Q4 2013 Core results excluding Diagnostics 4 |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | -63 | 302 | 1 | 240 | 167 | ||||||||||
| Operating loss | -1�084 | 1�071 | 18 | -11 | -6 | -52 | |||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -584 | 302 | 1 | -281 | -354 | ||||||||||
| The following are adjustments to arrive at Core Operating Loss | |||||||||||||||
| Other income | 10 | 4 | 14 | 17 | |||||||||||
| Other expense | -784 | 769 | 14 | -12 | -13 | -8 | |||||||||
|
1�Impairments: Cost of goods sold and Other expense include the USD 1.1 billion impairment charge as a result of the proposed sale of the influenza vaccines business.
|
|||||||||||||||
|
2�Acquisition or divestment related items, including restructuring and integration charges: Other income includes an adjustment to the gain on the disposal of the blood transfusion diagnostics unit on January 9, 2014; Other expense includes professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
3�Other exceptional items: Cost of goods sold relates to restructuring charges; Other expense includes prior period professional service fees which have been reclassed as acquisition related items, as well as an adjustment to a restructuring charge.
|
|||||||||||||||
|
4�2013 figures exclude the blood transfusion diagnostics unit which was divested on January 9, 2014.
|
|||||||||||||||
70
|
FY 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges 3 |
Other exceptional items 4 |
FY 2014 Core results |
FY 2013 Core results excluding Diagnostics 5 |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 298 | 49 | 302 | 1 | 650 | 529 | |||||||||
| Operating loss | -552 | 57 | 1�071 | -862 | -4 | -290 | -302 | ||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -1�336 | 49 | 302 | 1 | -984 | -981 | |||||||||
| The following are adjustments to arrive at Core Operating Loss | |||||||||||||||
| Research & Development | -545 | 8 | -537 | -423 | |||||||||||
| Other income | 905 | -876 | 29 | 61 | |||||||||||
| Other expense | -812 | 769 | 14 | -5 | -34 | -61 | |||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets up to the portfolio transformation announcement date; Research & Development includes the recurring amortization of acquired rights for technology platforms up to the portfolio transformation announcement date.
|
|||||||||||||||
|
2�Impairments: Cost of goods sold and Other expense include the USD 1.1 billion impairment charge as a result of the proposed sale of the influenza vaccines business.
|
|||||||||||||||
|
3�Acquisition or divestment related items, including restructuring and integration charges: Other income includes the gain on the disposal of the blood transfusion diagnostics unit on January 9, 2014; Other expense includes professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
4�Other exceptional items: Cost of goods sold relates to restructuring charges; Other expense includes an adjustment to a restructuring charge.
|
|||||||||||||||
|
5�2013 figures exclude the blood transfusion diagnostics unit which was divested on January 9, 2014.
|
|||||||||||||||
|
�
|
|||||||||||||||
71
|
Q4 2014 IFRS results |
Amortization of intangible assets |
Impairments 1 |
Acquisition or divestment related items, including restructuring and integration charges 2 |
Other exceptional items 3 |
Q4 2014 Core results |
Q4 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 629 | 7 | 636 | 622 | |||||||||||
| Operating income | 172 | 1 | 23 | -81 | 115 | 60 | |||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -438 | 7 | -431 | -425 | |||||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Other income | 83 | 1 | -81 | 3 | 21 | ||||||||||
| Other expense | -16 | 23 | -7 | -5 | |||||||||||
|
1�Impairments: Other income includes an adjustment to an impairment charge reversal for property, plant and equipment.
|
|||||||||||||||
|
2�Acquisition or divestment related items, including restructuring and integration charges: Other expense also includes professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
3�Other exceptional items: Cost of goods sold and Other expense include restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes the gain on the sale of a divested product, which was sold as a result of the proposed portfolio transformation transaction, as well as the reversal of restructuring charges related to the Group-wide rationalization of manufacturing sites; Other expense includes prior period professional service fees which have been reclassed as acquisition related items.
|
|||||||||||||||
72
|
FY 2014 IFRS results |
Amortization of intangible assets 1 |
Impairments 2 |
Acquisition or divestment related items, including restructuring and integration charges 3 |
Other exceptional items 4 |
FY 2014 Core results |
FY 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 2�588 | 16 | 18 | 2�622 | 2�442 | ||||||||||
| Operating income | 470 | 16 | -1 | 23 | -56 | 452 | 298 | ||||||||
| The following are adjustments to arrive at Core Gross Profit | |||||||||||||||
| Cost of goods sold | -1�737 | 16 | 18 | -1�703 | -1�669 | ||||||||||
| The following are adjustments to arrive at Core Operating Income | |||||||||||||||
| Other income | 99 | -1 | -89 | 9 | 77 | ||||||||||
| Other expense | -60 | 23 | 15 | -22 | -23 | ||||||||||
|
1�Amortization of intangible assets: Cost of goods sold includes recurring amortization of acquired rights to in-market products and other production-related intangible assets up to the portfolio transformation announcement date.
|
|||||||||||||||
|
2�Impairments: Other income includes a reduction of an impairment charge for property, plant and equipment.
|
|||||||||||||||
|
3�Acquisition or divestment related items, including restructuring and integration charges: Other expense includes professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
4�Other exceptional items: Cost of goods sold and Other expense include net restructuring charges related to the Group-wide rationalization of manufacturing sites; Other income includes the gain on the sale of a divested product, which was sold as a result of the proposed portfolio transformation transaction, the reversal of restructuring charges related to the Group-wide rationalization of manufacturing sites, the partial reversal of a legal expense provision, and the impact from a post-retirement medical plan amendment.
|
|||||||||||||||
73
|
Q4 2014 IFRS results |
Amortization of intangible assets |
Impairments 1 |
Acquisition or divestment related items, including restructuring and integration charges 2 |
Other exceptional items 3 |
Q4 2014 Core results |
Q4 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 0 | 0 | 0 | ||||||||||||
| Operating loss | -267 | 71 | 159 | 21 | -16 | -5 | |||||||||
| The following are adjustments to arrive at Core Operating Loss | |||||||||||||||
| Other expense | -265 | 71 | 159 | 21 | -14 | -10 | |||||||||
|
�
|
|||||||||||||||
|
1�Impairments: Other expense relates to an impairment charge incurred for an in-process project which is pending divestment as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
|
2�Acquisition or divestment related items, including restructuring and integration charges: Other expense includes professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
3�Other exceptional items: Other expense relates to a write-off of a receivable as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
74
|
FY 2014 IFRS results |
Amortization of intangible assets |
Impairments 1 |
Acquisition or divestment related items, including restructuring and integration charges 2 |
Other exceptional items 3 |
FY 2014 Core results |
FY 2013 Core results |
|||||||||
| USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | USD millions | |||||||||
| Gross profit | 0 | 0 | 0 | ||||||||||||
| Operating loss | -271 | 71 | 159 | 22 | -19 | -12 | |||||||||
| The following are adjustments to arrive at Core Operating Loss | |||||||||||||||
| Other expense | -274 | 71 | 159 | 22 | -22 | -36 | |||||||||
|
�
|
|||||||||||||||
|
1�Impairments: Other expense relates to an impairment charge incurred for an in-process project which is pending divestment as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
|
2�Acquisition or divestment related items, including restructuring and integration charges: Other expense includes professional service fees related to the portfolio transformation divestment activities.
|
|||||||||||||||
|
3�Other exceptional items: Other expense relates to a write-off of a receivable as a result of the proposed portfolio transformation transactions.
|
|||||||||||||||
75
Fourth quarter
|
Q4 2014 USD m |
Q4 2013 USD m |
||||
| Change in cash and cash equivalents | 3�382 | 324 | |||
| Change in marketable securities, commodities, financial debt and financial derivatives | -751 | 2�316 | |||
| Reduction in net debt | 2�631 | 2�640 | |||
| Net debt at October 1 | -9�180 | -11�436 | |||
| Net debt at December 31 | -6�549 | -8�796 | |||
Full year
|
FY 2014 USD m |
FY 2013 USD m |
||||
| Change in cash and cash equivalents | 6�336 | 1�135 | |||
| Change in marketable securities, commodities, financial debt and financial derivatives | -4�089 | 1�676 | |||
| Reduction in net debt | 2�247 | 2�811 | |||
| Net debt at January 1 | -8�796 | -11�607 | |||
| Net debt at December 31 | -6�549 | -8�796 | |||
Components of net debt
|
Dec 31, 2014 USD m |
Dec 31, 2013 USD m |
||||
| Current financial debts and derivative financial instruments | -6�612 | -6�776 | |||
| Non-current financial debts | -13�799 | -11�242 | |||
| Less liquidity: | |||||
| Cash and cash equivalents | 13�023 | 6�687 | |||
| Marketable securities, commodities and derivative financial instruments | 839 | 2�535 | |||
| Net debt at December 31 | -6�549 | -8�796 | |||
Share information
|
Dec 31, 2014 |
Dec 31, 2013 |
||||
| Number of shares outstanding | 2�398�626�257 | 2�426�084�308 | |||
| Registered share price (CHF) | 92.35 | 71.20 | |||
| ADR price (USD) | 92.66 | 80.38 | |||
| Market capitalization (USD billion) | 223.7 | 194.2 | |||
| Market capitalization (CHF billion) | 221.5 | 172.7 | |||
76
Fourth quarter
|
Q4 2014 USD m |
Q4 2013 USD m |
Change USD m |
|||||
| Operating income from continuing operations | 2�351 | 2�333 | 18 | ||||
| Reversal of non-cash items | |||||||
|
Depreciation, amortization and impairments
|
1�291 | 1�211 | 80 | ||||
|
Change in provisions and other non-current liabilities
|
316 | 204 | 112 | ||||
|
Other
|
-118 | -6 | -112 | ||||
| Operating income adjusted for non-cash items | 3�840 | 3�742 | 98 | ||||
| Interest and other financial receipts | 394 | -65 | 459 | ||||
| Interest and other financial payments | -168 | -90 | -78 | ||||
| Taxes paid | -559 | -509 | -50 | ||||
| Payments out of provisions and other net cash movements in non-current liabilities | -251 | -302 | 51 | ||||
| Change in inventory and trade receivables less trade payables | 1�422 | 1�332 | 90 | ||||
| Change in other net current assets and other operating cash flow items | 45 | -146 | 191 | ||||
| Cash flows from operating activities from continuing operations | 4�723 | 3�962 | 761 | ||||
| Purchase of property, plant & equipment | -830 | -1�048 | 218 | ||||
| Purchase of intangible, financial and other non-current assets | -304 | -218 | -86 | ||||
| Proceeds from sales of property, plant & equipment, intangible, financial and other non-current assets | 366 | 179 | 187 | ||||
| Free cash flow from continuing operations | 3�955 | 2�875 | 1�080 | ||||
| Free cash flow from discontinuing operations | 464 | 444 | 20 | ||||
| Total free cash flow | 4�419 | 3�319 | 1�100 | ||||
Full year
|
FY 2014 USD m |
FY 2013 USD m |
Change USD m |
|||||
| Operating income from continuing operations | 11�089 | 10�983 | 106 | ||||
| Reversal of non-cash items | |||||||
|
Depreciation, amortization and impairments
|
4�751 | 4�462 | 289 | ||||
|
Change in provisions and other non-current liabilities
|
1�490 | 736 | 754 | ||||
|
Other
|
122 | 307 | -185 | ||||
| Operating income adjusted for non-cash items | 17�452 | 16�488 | 964 | ||||
| Interest and other financial receipts | 1�067 | 539 | 528 | ||||
| Interest and other financial payments | -692 | -631 | -61 | ||||
| Taxes paid | -2�179 | -2�054 | -125 | ||||
| Payments out of provisions and other net cash movements in non-current liabilities | -1�125 | -947 | -178 | ||||
| Change in inventory and trade receivables less trade payables | -731 | -588 | -143 | ||||
| Change in other net current assets and other operating cash flow items | 106 | -190 | 296 | ||||
| Cash flows from operating activities from continuing operations | 13�898 | 12�617 | 1�281 | ||||
| Purchase of property, plant & equipment | -2�624 | -2�903 | 279 | ||||
| Purchase of intangible, financial and other non-current assets | -1�079 | -665 | -414 | ||||
| Proceeds from sales of property, plant & equipment, intangible, financial and other non-current assets | 739 | 472 | 267 | ||||
| Free cash flow from continuing operations | 10�934 | 9�521 | 1�413 | ||||
| Free cash flow from discontinuing operations | -172 | 424 | -596 | ||||
| Total free cash flow | 10�762 | 9�945 | 817 | ||||
77
| US | Rest of world | Total | |||||||||||||||||
|
Brands |
Business Franchise |
Indication |
USD m |
% change in constant currencies |
USD m |
% change in constant currencies |
USD m |
% change in USD |
% change in constant currencies |
||||||||||
| Gleevec/Glivec | Oncology | Chronic myeloid leukemia | 624 | 12 | 613 | -1 | 1�237 | 1 | 5 | ||||||||||
| Gilenya | Neuroscience | Relapsing multiple sclerosis | 325 | 29 | 341 | 36 | 666 | 26 | 32 | ||||||||||
| Lucentis | Ophthalmics | Age-related macular degeneration | 588 | 1 | 588 | -7 | 1 | ||||||||||||
| Diovan/Co–Diovan | Primary Care | Hypertension | 83 | -78 | 296 | -31 | 379 | -55 | -53 | ||||||||||
| Sandostatin | Oncology | Acromegaly | 198 | 7 | 218 | 3 | 416 | 5 | |||||||||||
| Afinitor/Votubia | Oncology | Breast cancer | 224 | 24 | 202 | 23 | 426 | 18 | 24 | ||||||||||
| Tasigna | Oncology | Chronic myeloid leukemia | 152 | 32 | 276 | 29 | 428 | 22 | 30 | ||||||||||
| Exforge | Primary Care | Hypertension | 20 | -77 | 278 | 6 | 298 | -20 | -14 | ||||||||||
| Galvus | Primary Care | Diabetes | 295 | -1 | 295 | -10 | -1 | ||||||||||||
| Exelon/Exelon Patch | Neuroscience | Alzheimer's disease | 120 | 12 | 120 | -9 | 240 | -4 | 0 | ||||||||||
| Exjade | Oncology | Iron chelator | 81 | 14 | 162 | 2 | 243 | 0 | 5 | ||||||||||
| Xolair1 | Primary Care | Asthma | 200 | 25 | 200 | 16 | 25 | ||||||||||||
| Neoral/Sandimmun | Integrated Hospital Care | Transplantation | 14 | 8 | 150 | -10 | 164 | -16 | -9 | ||||||||||
| Voltaren (excl. other divisions) | Established medicines | Inflammation/pain | 172 | 4 | 172 | -2 | 4 | ||||||||||||
| Myfortic | Integrated Hospital Care | Transplantation | 34 | -55 | 97 | 32 | 131 | -18 | -10 | ||||||||||
| Ritalin/Focalin | Established medicines | Attention deficit/ hyperactivity disorder | 86 | -27 | 42 | 9 | 128 | -20 | -18 | ||||||||||
| Femara | Oncology | Breast cancer | 9 | 80 | 89 | 3 | 98 | -2 | 6 | ||||||||||
| Comtan/Stalevo | Neuroscience | Parkinson’s disease | 2 | -78 | 87 | 2 | 89 | -14 | -5 | ||||||||||
| Tegretol | Established medicines | Epilepsy | 19 | 6 | 67 | 2 | 86 | -4 | 2 | ||||||||||
| Zortress/Certican | Integrated Hospital Care | Transplantation | 18 | 80 | 67 | 40 | 85 | 35 | 45 | ||||||||||
| Top 20 products total | 2�009 | -8 | 4�360 | 4 | 6�369 | -6 | 0 | ||||||||||||
| Rest of portfolio | 365 | -5 | 1�126 | 3 | 1�491 | -4 | 1 | ||||||||||||
| Total Division sales | 2�374 | -8 | 5�486 | 3 | 7�860 | -6 | 0 | ||||||||||||
|
�
|
|||||||||||||||||||
|
1�Net sales reflect Xolair sales for all indications (i.e. Xolair SAA and Xolair CSU, which are managed by the Integrated Hospital Care franchise).
|
|||||||||||||||||||
78
| US | Rest of world | Total | |||||||||||||||||
|
Brands |
Business Franchise |
Indication |
USD m |
% change in constant currencies |
USD m |
% change in constant currencies |
USD m |
% change in USD |
% change in constant currencies |
||||||||||
| Gleevec/Glivec | Oncology | Chronic myeloid leukemia | 2�170 | 12 | 2�576 | -5 | 4�746 | 1 | 2 | ||||||||||
| Gilenya | Neuroscience | Relapsing multiple sclerosis | 1�190 | 16 | 1�287 | 45 | 2�477 | 28 | 30 | ||||||||||
| Lucentis | Ophthalmics | Age-related macular degeneration | 2�441 | 5 | 2�441 | 2 | 5 | ||||||||||||
| Diovan/Co–Diovan | Primary Care | Hypertension | 960 | -43 | 1�385 | -22 | 2�345 | -33 | -32 | ||||||||||
| Sandostatin | Oncology | Acromegaly | 751 | 6 | 899 | 6 | 1�650 | 4 | 6 | ||||||||||
| Afinitor/Votubia | Oncology | Breast cancer | 805 | 16 | 770 | 29 | 1�575 | 20 | 22 | ||||||||||
| Tasigna | Oncology | Chronic myeloid leukemia | 540 | 26 | 989 | 23 | 1�529 | 21 | 24 | ||||||||||
| Exforge | Primary Care | Hypertension | 284 | -20 | 1�112 | 4 | 1�396 | -4 | -2 | ||||||||||
| Galvus | Primary Care | Diabetes | 1�224 | 6 | 1�224 | 2 | 6 | ||||||||||||
| Exelon/Exelon Patch | Neuroscience | Alzheimer's disease | 485 | 6 | 524 | -6 | 1�009 | -2 | -1 | ||||||||||
| Exjade | Oncology | Iron chelator | 307 | 16 | 619 | 1 | 926 | 4 | 6 | ||||||||||
| Xolair1 | Primary Care | Asthma | 777 | 30 | 777 | 27 | 30 | ||||||||||||
| Neoral/Sandimmun | Integrated Hospital Care | Transplantation | 55 | -2 | 629 | -6 | 684 | -9 | -6 | ||||||||||
| Voltaren (excl. other divisions) | Established medicines | Inflammation/pain | 632 | -3 | 632 | -6 | -3 | ||||||||||||
| Myfortic | Integrated Hospital Care | Transplantation | 149 | -45 | 394 | 14 | 543 | -15 | -11 | ||||||||||
| Ritalin/Focalin | Established medicines | Attention deficit/ hyperactivity disorder | 327 | -25 | 165 | 8 | 492 | -17 | -16 | ||||||||||
| Femara | Oncology | Breast cancer | 27 | 42 | 353 | 0 | 380 | -1 | 2 | ||||||||||
| Comtan/Stalevo | Neuroscience | Parkinson’s disease | 19 | -42 | 352 | -1 | 371 | -7 | -4 | ||||||||||
| Tegretol | Established medicines | Epilepsy | 82 | 19 | 264 | 1 | 346 | 1 | 4 | ||||||||||
| Zortress/Certican | Integrated Hospital Care | Transplantation | 60 | 88 | 267 | 28 | 327 | 31 | 36 | ||||||||||
| Top 20 products total | 8�211 | -3 | 17�659 | 4 | 25�870 | 0 | 2 | ||||||||||||
| Rest of portfolio | 1�561 | -13 | 4�360 | 0 | 5�921 | -6 | -4 | ||||||||||||
| Total Division sales | 9�772 | -5 | 22�019 | 3 | 31�791 | -1 | 1 | ||||||||||||
|
�
|
|||||||||||||||||||
|
1�Net sales reflect Xolair sales for all indications (i.e. Xolair SAA and Xolair CSU, which are managed by the Integrated Hospital Care franchise).
|
|||||||||||||||||||
79
|
Q4 2014 USD m |
Q4 2013 USD m |
% change USD |
% change cc |
||||||
| Primary Care | |||||||||
| Onbrez Breezhaler/Arcapta Neohaler | 56 | 53 | 6 | 15 | |||||
| Seebri Breezhaler | 42 | 25 | 68 | 88 | |||||
| Ultibro Breezhaler | 51 | 6 | nm | nm | |||||
| Subtotal COPD1 portfolio | 149 | 84 | 77 | 94 | |||||
| Galvus | 295 | 328 | -10 | -1 | |||||
| Xolair2 | 200 | 173 | 16 | 25 | |||||
| TOBI | 65 | 88 | -26 | -23 | |||||
| Other | 8 | 10 | -20 | 2 | |||||
| Total strategic franchise products | 717 | 683 | 5 | 14 | |||||
| Diovan | 379 | 843 | -55 | -53 | |||||
| Exforge | 298 | 372 | -20 | -14 | |||||
| Tekturna/Rasilez | 47 | 59 | -20 | -15 | |||||
| Other | 274 | 352 | -22 | -16 | |||||
| Total Established medicines | 998 | 1�626 | -39 | -34 | |||||
| Total Primary Care products | 1�715 | 2�309 | -26 | -20 | |||||
| Oncology | |||||||||
| Gleevec/Glivec | 1�237 | 1�227 | 1 | 5 | |||||
| Tasigna | 428 | 352 | 22 | 30 | |||||
| Subtotal Bcr-Abl franchise | 1�665 | 1�579 | 5 | 10 | |||||
| Sandostatin | 416 | 416 | 0 | 5 | |||||
| Afinitor/Votubia | 426 | 361 | 18 | 24 | |||||
| Exjade | 243 | 244 | 0 | 5 | |||||
| Femara | 98 | 100 | -2 | 6 | |||||
| Jakavi | 84 | 47 | 79 | 91 | |||||
| Zometa | 57 | 94 | -39 | -34 | |||||
| Proleukin | 15 | 26 | -42 | -42 | |||||
| Zykadia | 12 | 0 | nm | nm | |||||
| Other | 66 | 60 | 10 | 11 | |||||
| Total Oncology products | 3�082 | 2�927 | 5 | 10 | |||||
| Specialty - Neuroscience | |||||||||
| Gilenya | 666 | 527 | 26 | 32 | |||||
| Exelon/Exelon Patch | 240 | 250 | -4 | 0 | |||||
| Comtan/Stalevo | 89 | 103 | -14 | -5 | |||||
| Extavia | 43 | 37 | 16 | 20 | |||||
| Other | 16 | 21 | -24 | -24 | |||||
| Total strategic franchise products | 1�054 | 938 | 12 | 18 | |||||
| Established medicines | 100 | 112 | -11 | -2 | |||||
| Total Neuroscience products | 1�154 | 1�050 | 10 | 16 | |||||
| Specialty - Ophthalmics | |||||||||
| Lucentis | 588 | 630 | -7 | 1 | |||||
| Other | 13 | 14 | -7 | -4 | |||||
| Total Opthalmics products | 601 | 644 | -7 | 1 | |||||
| Specialty - Integrated Hospital Care (IHC) | |||||||||
| Neoral/Sandimmun | 164 | 195 | -16 | -9 | |||||
| Myfortic | 131 | 159 | -18 | -10 | |||||
| Zortress/Certican | 85 | 63 | 35 | 45 | |||||
| Ilaris | 54 | 37 | 46 | 54 | |||||
| Other | 45 | 43 | 5 | 9 | |||||
| Total strategic franchise products | 479 | 497 | -4 | 4 | |||||
| Everolimus stent drug | 62 | 46 | 35 | 46 | |||||
| Established medicines | 224 | 259 | -14 | -9 | |||||
| Total IHC products | 765 | 802 | -5 | 2 | |||||
| Established medicines - additional products | |||||||||
| Voltaren (excl. other divisions) | 172 | 176 | -2 | 4 | |||||
| Ritalin/Focalin | 128 | 161 | -20 | -18 | |||||
| Tegretol | 86 | 90 | -4 | 2 | |||||
| Trileptal | 59 | 69 | -14 | -10 | |||||
| Foradil | 43 | 55 | -22 | -12 | |||||
| Other | 55 | 40 | 38 | 39 | |||||
| Total additional products | 543 | 591 | -8 | -3 | |||||
| Total strategic franchise products | 5�933 | 5�689 | 4 | 11 | |||||
| Total established medicines and additional products | 1�927 | 2�634 | -27 | -22 | |||||
| Total Division net sales | 7�860 | 8�323 | -6 | 0 | |||||
|
1�Chronic Obstructive Pulmonary Disease
|
|||||||||
|
2�Net sales reflect Xolair sales for all indications (i.e. Xolair SAA and Xolair CSU, which are managed by the Integrated Hospital Care franchise).
|
|||||||||
| nm = not meaningful | |||||||||
80
|
FY 2014 USD m |
FY 2013 USD m |
% change USD |
% change cc |
||||||
| Primary Care | |||||||||
| Onbrez Breezhaler/Arcapta Neohaler | 220 | 192 | 15 | 17 | |||||
| Seebri Breezhaler | 146 | 58 | 152 | 159 | |||||
| Ultibro Breezhaler | 118 | 6 | nm | nm | |||||
| Subtotal COPD1 portfolio | 484 | 256 | 89 | 93 | |||||
| Galvus | 1�224 | 1�200 | 2 | 6 | |||||
| Xolair2 | 777 | 613 | 27 | 30 | |||||
| TOBI | 281 | 387 | -27 | -26 | |||||
| Other | 46 | 40 | 15 | 20 | |||||
| Total strategic franchise products | 2�812 | 2�496 | 13 | 16 | |||||
| Diovan | 2�345 | 3�524 | -33 | -32 | |||||
| Exforge | 1�396 | 1�456 | -4 | -2 | |||||
| Tekturna/Rasilez | 207 | 290 | -29 | -27 | |||||
| Other | 1�201 | 1�312 | -8 | -6 | |||||
| Total Established medicines | 5�149 | 6�582 | -22 | -20 | |||||
| Total Primary Care products | 7�961 | 9�078 | -12 | -10 | |||||
| Oncology | |||||||||
| Gleevec/Glivec | 4�746 | 4�693 | 1 | 2 | |||||
| Tasigna | 1�529 | 1�266 | 21 | 24 | |||||
| Subtotal Bcr-Abl franchise | 6�275 | 5�959 | 5 | 7 | |||||
| Sandostatin | 1�650 | 1�589 | 4 | 6 | |||||
| Afinitor/Votubia | 1�575 | 1�309 | 20 | 22 | |||||
| Exjade | 926 | 893 | 4 | 6 | |||||
| Femara | 380 | 384 | -1 | 2 | |||||
| Jakavi | 279 | 163 | 71 | 72 | |||||
| Zometa | 264 | 600 | -56 | -55 | |||||
| Proleukin | 74 | 91 | -19 | -19 | |||||
| Zykadia | 31 | 0 | nm | nm | |||||
| Other | 249 | 228 | 9 | 10 | |||||
| Total Oncology products | 11�703 | 11�216 | 4 | 6 | |||||
| Specialty - Neuroscience | |||||||||
| Gilenya | 2�477 | 1�934 | 28 | 30 | |||||
| Exelon/Exelon Patch | 1�009 | 1�032 | -2 | -1 | |||||
| Comtan/Stalevo | 371 | 401 | -7 | -4 | |||||
| Extavia | 177 | 159 | 11 | 11 | |||||
| Other | 66 | 78 | -15 | -15 | |||||
| Total strategic franchise products | 4�100 | 3�604 | 14 | 15 | |||||
| Established medicines | 409 | 444 | -8 | -3 | |||||
| Total Neuroscience products | 4�509 | 4�048 | 11 | 13 | |||||
| Specialty - Ophthalmics | |||||||||
| Lucentis | 2�441 | 2�383 | 2 | 5 | |||||
| Other | 63 | 61 | 3 | 5 | |||||
| Total Opthalmics products | 2�504 | 2�444 | 2 | 5 | |||||
| Specialty - Integrated Hospital Care (IHC) | |||||||||
| Neoral/Sandimmun | 684 | 750 | -9 | -6 | |||||
| Myfortic | 543 | 637 | -15 | -11 | |||||
| Zortress/Certican | 327 | 249 | 31 | 36 | |||||
| Ilaris | 199 | 119 | 67 | 69 | |||||
| Other | 173 | 169 | 2 | 4 | |||||
| Total strategic franchise products | 1�926 | 1�924 | 0 | 3 | |||||
| Everolimus stent drug | 205 | 247 | -17 | -18 | |||||
| Established medicines | 981 | 1�112 | -12 | -10 | |||||
| Total IHC products | 3�112 | 3�283 | -5 | -3 | |||||
| Established medicines - additional products | |||||||||
| Voltaren (excl. other divisions) | 632 | 675 | -6 | -3 | |||||
| Ritalin/Focalin | 492 | 594 | -17 | -16 | |||||
| Tegretol | 346 | 342 | 1 | 4 | |||||
| Trileptal | 265 | 257 | 3 | 6 | |||||
| Foradil | 175 | 205 | -15 | -10 | |||||
| Other | 92 | 72 | 28 | 29 | |||||
| Total additional products | 2�002 | 2�145 | -7 | -4 | |||||
| Total strategic franchise products | 23�045 | 21�684 | 6 | 8 | |||||
| Total established medicines and additional products | 8�746 | 10�530 | -17 | -15 | |||||
| Total Division net sales | 31�791 | 32�214 | -1 | 1 | |||||
|
1�Chronic Obstructive Pulmonary Disease
|
|||||||||
|
2�Net sales reflect Xolair sales for all indications (i.e. Xolair SAA and Xolair CSU, which are managed by the Integrated Hospital Care franchise).
|
|||||||||
| nm = not meaningful | |||||||||
81
| Q4 2014 | Q4 2013 | % change | Q4 2014 | Q4 2013 | |||||||||
| USD m | USD m | USD | cc | % of total | % of total | ||||||||
| Pharmaceuticals | |||||||||||||
|
Europe
|
2�733 | 2�847 | -4 | 5 | 35 | 34 | |||||||
|
US
|
2�374 | 2�572 | -8 | -8 | 30 | 31 | |||||||
|
Asia/Africa/Australasia
|
1�880 | 2�105 | -11 | -5 | 24 | 25 | |||||||
|
Canada and Latin America
|
873 | 799 | 9 | 19 | 11 | 10 | |||||||
| Total | 7�860 | 8�323 | -6 | 0 | 100 | 100 | |||||||
|
Of which in Established Markets
|
5�687 | 6�256 | -9 | -4 | 72 | 75 | |||||||
|
Of which in Emerging Growth Markets
|
2�173 | 2�067 | 5 | 13 | 28 | 25 | |||||||
| Alcon | |||||||||||||
|
Europe
|
695 | 749 | -7 | 4 | 26 | 28 | |||||||
|
US
|
1�108 | 1�028 | 8 | 8 | 41 | 39 | |||||||
|
Asia/Africa/Australasia
|
610 | 597 | 2 | 9 | 23 | 22 | |||||||
|
Canada and Latin America
|
290 | 281 | 3 | 12 | 10 | 11 | |||||||
| Total | 2�703 | 2�655 | 2 | 7 | 100 | 100 | |||||||
|
Of which in Established Markets
|
1�995 | 1�994 | 0 | 4 | 74 | 75 | |||||||
|
Of which in Emerging Growth Markets
|
708 | 661 | 7 | 17 | 26 | 25 | |||||||
| Sandoz | |||||||||||||
|
Europe
|
1�111 | 1�207 | -8 | 3 | 44 | 50 | |||||||
|
US
|
935 | 737 | 27 | 27 | 37 | 31 | |||||||
|
Asia/Africa/Australasia
|
308 | 316 | -3 | 2 | 12 | 13 | |||||||
|
Canada and Latin America
|
158 | 151 | 5 | 16 | 7 | 6 | |||||||
| Total | 2�512 | 2�411 | 4 | 11 | 100 | 100 | |||||||
|
Of which in Established Markets
|
1�877 | 1�735 | 8 | 13 | 75 | 72 | |||||||
|
Of which in Emerging Growth Markets
|
635 | 676 | -6 | 6 | 25 | 28 | |||||||
| Continuing operations | |||||||||||||
|
Europe
|
4�539 | 4�803 | -5 | 4 | 35 | 36 | |||||||
|
US
|
4�417 | 4�337 | 2 | 2 | 34 | 32 | |||||||
|
Asia/Africa/Australasia
|
2�798 | 3�018 | -7 | -1 | 21 | 23 | |||||||
|
Canada and Latin America
|
1�321 | 1�231 | 7 | 17 | 10 | 9 | |||||||
| Total | 13�075 | 13�389 | -2 | 3 | 100 | 100 | |||||||
|
Of which in Established Markets
|
9�559 | 9�985 | -4 | 0 | 73 | 75 | |||||||
|
Of which in Emerging Growth Markets
|
3�516 | 3�404 | 3 | 12 | 27 | 25 | |||||||
| Vaccines2 | |||||||||||||
|
Europe
|
198 | 165 | 20 | 29 | 40 | 33 | |||||||
|
US
|
128 | 171 | -25 | -25 | 26 | 34 | |||||||
|
Asia/Africa/Australasia
|
81 | 95 | -15 | -12 | 16 | 19 | |||||||
|
Canada and Latin America
|
87 | 73 | 19 | 39 | 18 | 14 | |||||||
| Total | 494 | 504 | -2 | 4 | 100 | 100 | |||||||
|
Of which in Established Markets
|
340 | 352 | -3 | 2 | 69 | 70 | |||||||
|
Of which in Emerging Growth Markets
|
154 | 152 | 1 | 10 | 31 | 30 | |||||||
| Consumer Health | |||||||||||||
|
Europe
|
465 | 506 | -8 | 4 | 44 | 49 | |||||||
|
US
|
247 | 210 | 18 | 18 | 23 | 20 | |||||||
|
Asia/Africa/Australasia
|
224 | 202 | 11 | 16 | 21 | 20 | |||||||
|
Canada and Latin America
|
128 | 116 | 10 | 17 | 12 | 11 | |||||||
| Total | 1�064 | 1�034 | 3 | 11 | 100 | 100 | |||||||
|
Of which in Established Markets
|
682 | 663 | 3 | 8 | 64 | 64 | |||||||
|
Of which in Emerging Growth Markets
|
382 | 371 | 3 | 15 | 36 | 36 | |||||||
| Total | |||||||||||||
|
Europe
|
5�202 | 5�474 | -5 | 5 | 36 | 37 | |||||||
|
US
|
4�792 | 4�718 | 2 | 2 | 33 | 32 | |||||||
|
Asia/Africa/Australasia
|
3�103 | 3�315 | -6 | -1 | 21 | 22 | |||||||
|
Canada and Latin America
|
1�536 | 1�420 | 8 | 18 | 10 | 9 | |||||||
| Total (excluding divested blood transfusion diagnostics unit sales) | 14�633 | 14�927 | -2 | 4 | 100 | 100 | |||||||
|
Of which in Established Markets
|
10�581 | 11�000 | -4 | 1 | 72 | 74 | |||||||
|
Of which in Emerging Growth Markets
|
4�052 | 3�927 | 3 | 12 | 28 | 26 | |||||||
| Divested blood transfusion diagnostics unit sales | 152 | ||||||||||||
| Total Group | 14�633 | 15�079 | -3 | 3 | |||||||||
|
1�Net sales from operations by location of third party customer. Emerging Growth Markets comprise all markets other than the Established Markets of the US, Canada, Western Europe, Japan, Australia and New Zealand.
|
|||||||||||||
|
2�2013 figures for Vaccines exclude the blood transfusion diagnostics unit that was divested on January 9, 2014.
|
|||||||||||||
82
| FY 2014 | FY 2013 2 | % change | FY 2014 | FY 2013 | |||||||||
| USD m | USD m | USD | cc | % of total | % of total | ||||||||
| Pharmaceuticals | |||||||||||||
|
Europe
|
11�245 | 10�993 | 2 | 3 | 35 | 34 | |||||||
|
US
|
9�772 | 10�256 | -5 | -5 | 31 | 32 | |||||||
|
Asia/Africa/Australasia
|
7�655 | 7�947 | -4 | 0 | 24 | 25 | |||||||
|
Canada and Latin America
|
3�119 | 3�018 | 3 | 13 | 10 | 9 | |||||||
| Total | 31�791 | 32�214 | -1 | 1 | 100 | 100 | |||||||
|
Of which in Established Markets
|
23�653 | 24�493 | -3 | -2 | 74 | 76 | |||||||
|
Of which in Emerging Growth Markets
|
8�138 | 7�721 | 5 | 11 | 26 | 24 | |||||||
| Alcon | |||||||||||||
|
Europe
|
2�872 | 2�831 | 1 | 4 | 27 | 27 | |||||||
|
US
|
4�349 | 4�179 | 4 | 4 | 40 | 40 | |||||||
|
Asia/Africa/Australasia
|
2�449 | 2�378 | 3 | 8 | 23 | 23 | |||||||
|
Canada and Latin America
|
1�157 | 1�108 | 4 | 12 | 10 | 10 | |||||||
| Total | 10�827 | 10�496 | 3 | 6 | 100 | 100 | |||||||
|
Of which in Established Markets
|
8�049 | 7�918 | 2 | 3 | 74 | 75 | |||||||
|
Of which in Emerging Growth Markets
|
2�778 | 2�578 | 8 | 14 | 26 | 25 | |||||||
| Sandoz | |||||||||||||
|
Europe
|
4�573 | 4�596 | -1 | 2 | 48 | 50 | |||||||
|
US
|
3�215 | 2�821 | 14 | 14 | 34 | 31 | |||||||
|
Asia/Africa/Australasia
|
1�168 | 1�139 | 3 | 6 | 12 | 12 | |||||||
|
Canada and Latin America
|
606 | 603 | 0 | 8 | 6 | 7 | |||||||
| Total | 9�562 | 9�159 | 4 | 7 | 100 | 100 | |||||||
|
Of which in Established Markets
|
7�035 | 6�625 | 6 | 7 | 74 | 72 | |||||||
|
Of which in Emerging Growth Markets
|
2�527 | 2�534 | 0 | 6 | 26 | 28 | |||||||
| Continuing operations | |||||||||||||
|
Europe
|
18�690 | 18�420 | 1 | 3 | 36 | 36 | |||||||
|
US
|
17�336 | 17�256 | 0 | 0 | 33 | 33 | |||||||
|
Asia/Africa/Australasia
|
11�272 | 11�464 | -2 | 2 | 22 | 22 | |||||||
|
Canada and Latin America
|
4�882 | 4�729 | 3 | 12 | 9 | 9 | |||||||
| Total | 52�180 | 51�869 | 1 | 3 | 100 | 100 | |||||||
|
Of which in Established Markets
|
38�737 | 39�036 | -1 | 0 | 74 | 75 | |||||||
|
Of which in Emerging Growth Markets
|
13�443 | 12�833 | 5 | 10 | 26 | 25 | |||||||
| Vaccines2 | |||||||||||||
|
Europe
|
549 | 484 | 13 | 15 | 36 | 34 | |||||||
|
US
|
516 | 521 | -1 | -1 | 34 | 37 | |||||||
|
Asia/Africa/Australasia
|
248 | 242 | 2 | 3 | 16 | 17 | |||||||
|
Canada and Latin America
|
224 | 176 | 27 | 42 | 14 | 12 | |||||||
| Total | 1�537 | 1�423 | 8 | 10 | 100 | 100 | |||||||
|
Of which in Established Markets
|
1�112 | 1�035 | 7 | 8 | 72 | 73 | |||||||
|
Of which in Emerging Growth Markets
|
425 | 388 | 10 | 15 | 28 | 27 | |||||||
| Consumer Health | |||||||||||||
|
Europe
|
2�059 | 2�004 | 3 | 6 | 48 | 49 | |||||||
|
US
|
940 | 847 | 11 | 11 | 22 | 21 | |||||||
|
Asia/Africa/Australasia
|
834 | 793 | 5 | 8 | 19 | 20 | |||||||
|
Canada and Latin America
|
446 | 420 | 6 | 14 | 11 | 10 | |||||||
| Total | 4�279 | 4�064 | 5 | 8 | 100 | 100 | |||||||
|
Of which in Established Markets
|
2�798 | 2�636 | 6 | 7 | 65 | 65 | |||||||
|
Of which in Emerging Growth Markets
|
1�481 | 1�428 | 4 | 11 | 35 | 35 | |||||||
| Total | |||||||||||||
|
Europe
|
21�298 | 20�908 | 2 | 3 | 37 | 36 | |||||||
|
US
|
18�792 | 18�624 | 1 | 1 | 32 | 32 | |||||||
|
Asia/Africa/Australasia
|
12�354 | 12�499 | -1 | 3 | 21 | 22 | |||||||
|
Canada and Latin America
|
5�552 | 5�325 | 4 | 13 | 10 | 10 | |||||||
| Total (excluding divested blood transfusion diagnostics unit sales) | 57�996 | 57�356 | 1 | 3 | 100 | 100 | |||||||
|
Of which in Established Markets
|
42�647 | 42�707 | 0 | 1 | 74 | 74 | |||||||
|
Of which in Emerging Growth Markets
|
15�349 | 14�649 | 5 | 11 | 26 | 26 | |||||||
| Divested blood transfusion diagnostics unit sales | 565 | ||||||||||||
| Total Group | 57�996 | 57�921 | 0 | 2 | |||||||||
|
1�Net sales from operations by location of third party customer. Emerging Growth Markets comprise all markets other than the Established Markets of the US, Canada, Western Europe, Japan, Australia and New Zealand.
|
|||||||||||||
|
2�2013 figures for Vaccines exclude the blood transfusion diagnostics unit that was divested on January 9, 2014.
|
|||||||||||||
83
Fourth quarter
|
Average rates Q4 2014 USD |
Average rates Q4 2013 USD |
Period-end rates Dec 31, 2014 USD |
Period-end rates Dec 31, 2013 USD |
||||||
| 1 CHF | 1.037 | 1.107 | 1.010 | 1.124 | |||||
| 1 EUR | 1.249 | 1.361 | 1.215 | 1.378 | |||||
| 1 GBP | 1.583 | 1.619 | 1.556 | 1.653 | |||||
| 100 JPY | 0.875 | 0.997 | 0.836 | 0.952 | |||||
| 100 RUB | 2.125 | 3.071 | 1.722 | 3.044 | |||||
Full year
|
Average rates FY 2014 USD |
Average rates FY 2013 USD |
Period-end rates Dec 31, 2014 USD |
Period-end rates Dec 31, 2013 USD |
||||||
| 1 CHF | 1.094 | 1.079 | 1.010 | 1.124 | |||||
| 1 EUR | 1.329 | 1.328 | 1.215 | 1.378 | |||||
| 1 GBP | 1.648 | 1.564 | 1.556 | 1.653 | |||||
| 100 JPY | 0.947 | 1.026 | 0.836 | 0.952 | |||||
| 100 RUB | 2.649 | 3.142 | 1.722 | 3.044 | |||||
Income from associated companies
|
Q4 2014 USD m |
Q4 2013 USD m |
FY 2014 USD m |
FY 2013 USD m |
||||||
| Share of estimated Roche reported net income | 191 | 207 | 813 | 817 | |||||
| Prior-year adjustment | -56 | -59 | |||||||
| Amortization of additional intangible assets recognized by Novartis on initial accounting for the equity interest | -38 | -39 | -158 | -154 | |||||
| Net income effect from Roche | 153 | 168 | 599 | 604 | |||||
| LTS Lohmann Therapie-Systeme AG | 421 | 7 | 436 | 31 | |||||
| Idenix Pharmaceuticals Inc. | 812 | ||||||||
| Income from other associated companies related to continuing operations | 6 | -20 | 71 | -36 | |||||
| Income from associated companies related to continuing operations | 580 | 155 | 1�918 | 599 | |||||
| Income from other associated companies related to discontinuing operations | -1 | -1 | 2 | 1 | |||||
| Total income from associated companies | 579 | 154 | 1�920 | 600 | |||||
|
�
|
|||||||||
84
The following reconciles previously published results for the Vaccines segment to the revised presentation:
Vaccines – Fourth quarter and full year 2013
| Vaccines as previously published 1 | Transfers to continuing Corporate 2 | Reported Vaccines | Divested blood transfusion diagnostics unit | Vaccines excluding Diagnostics | Core adjustments | Vaccines Core result excluding Diagnostics | |||||||||||||||||||||||
|
Q4 2013 USD m |
FY 2013 USD m |
Q4 2013 USD m |
FY 2013 USD m |
Q4 2013 USD m |
FY 2013 USD m |
Q4 2013 USD m |
FY 2013 USD m |
Q4 2013 USD m |
FY 2013 USD m |
Q4 2013 USD m |
FY 2013 USD m |
Q4 2013 USD m |
FY 2013 USD m |
||||||||||||||||
| Net sales to third parties | 655 | 1�987 | 655 | 1�987 | -152 | -565 | 503 | 1�422 | 503 | 1�422 | |||||||||||||||||||
| Sales to other segment | 11 | 61 | 11 | 61 | -2 | -10 | 9 | 51 | 9 | 51 | |||||||||||||||||||
| Net sales of segment | 666 | 2�048 | 666 | 2�048 | -154 | -575 | 512 | 1�473 | 512 | 1�473 | |||||||||||||||||||
| Other revenues | 135 | 333 | -48 | -84 | 87 | 249 | -78 | -212 | 9 | 37 | 9 | 37 | |||||||||||||||||
| Cost of goods sold | -511 | -1�578 | 4 | 7 | -507 | -1�571 | 115 | 447 | -392 | -1�124 | 38 | 143 | -354 | -981 | |||||||||||||||
| Gross profit | 290 | 803 | -44 | -77 | 246 | 726 | -117 | -340 | 129 | 386 | 38 | 143 | 167 | 529 | |||||||||||||||
| Marketing & Sales | -91 | -334 | -91 | -334 | 14 | 45 | -77 | -289 | -77 | -289 | |||||||||||||||||||
| Research & Development | -132 | -476 | -132 | -476 | 6 | 29 | -126 | -447 | 6 | 24 | -120 | -423 | |||||||||||||||||
| General & Administration | -38 | -140 | -38 | -140 | 7 | 21 | -31 | -119 | -31 | -119 | |||||||||||||||||||
| Other income | 24 | 70 | 24 | 70 | -7 | -9 | 17 | 61 | 17 | 61 | |||||||||||||||||||
| Other expense | -11 | -88 | 1 | 4 | -10 | -84 | 2 | 15 | -8 | -69 | 8 | -8 | -61 | ||||||||||||||||
| Operating income/loss | 42 | -165 | -43 | -73 | -1 | -238 | -95 | -239 | -96 | -477 | 44 | 175 | -52 | -302 | |||||||||||||||
| as % of net sales | 6.4% | -8.3% | -0.2% | -12.0% | 62.5% | 42.3% | -19.1% | -33.5% | -10.3% | -21.2% | |||||||||||||||||||
| Income from associated companies | -1 | 1 | -1 | 1 | -1 | 1 | -1 | 1 | |||||||||||||||||||||
|
1�Including the divested blood transfusion diagnostics unit.
|
|||||||||||||||||||||||||||||
|
2�Other revenue contains royalties and out-licensing revenues of Vaccines which are to be retained by Novartis.
|
|||||||||||||||||||||||||||||
85
�
Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as pipeline, will, momentum, recommended, on track, ongoing, outlook, expected, confident, positioned, pending, to be acquired, strategy, launches, launched, launch, focus, positive opinions, could, initiated, to evaluate, moves towards, designed, in the future, expects, expect, would, committed, or similar terms, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; potential shareholder returns or credit ratings; or regarding the potential completion of the announced transactions with GSK and CSL, or regarding potential future sales or earnings of any of the businesses involved in the transactions with GSK, Lilly or CSL, and regarding any potential strategic benefits, synergies or opportunities as a result of these transactions; or regarding potential future sales or earnings of the Novartis Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee that the announced transactions with GSK and CSL will be completed in the expected form or within the expected time frame or at all. Neither can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the transactions with GSK, Lilly or CSL. Neither can there be any guarantee that Novartis or any of the businesses involved in the transactions will achieve any particular financial results in the future. Nor can there be any guarantee that shareholders will achieve any particular level of shareholder returns.�Neither can there be any guarantee that the Novartis Group, or any of its divisions, will be commercially successful in the future, or achieve any particular credit rating. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including an unexpected failure to obtain necessary government approvals for the transactions, or unexpected delays in obtaining such approvals; the potential that the strategic benefits, synergies or opportunities expected from the announced transactions, including the divestment of our former Animal Health Division to Lilly, may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the Companys ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on the Company of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; unexpected manufacturing or quality issues; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, government investigations and intellectual property disputes; general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries; uncertainties regarding future global exchange rates, including as a result of recent changes in monetary policy by the Swiss National Bank; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; uncertainties regarding potential significant breaches of data security or disruptions of the Companys information technology systems; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
All product names appearing in italics are trademarks owned by or licensed to Novartis Group Companies. Neupogen� is a registered trademark of Amgen Inc. Stelara� is a registered trademark of Janssen Biotech, Inc. Jakafi� is a registered trademark of Incyte Corporation.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 130,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
Novartis issued its 2014 Annual Report today, and it is available on its website at www.novartis.com. Novartis will also today file its 2014 Annual Report on Form 20-F with the US Securities and Exchange Commission, and will post this document on www.novartis.com. Novartis shareholders may receive a hard copy of either of these documents, each of which contain our complete audited financial statements, free of charge, upon request.
86
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Important dates
February 27, 2015������������������������������Annual General Meeting
April 23, 2015������������������������������������First quarter results 2015
June 17-18, 2015��������������������������������Novartis investor event in Boston, US
July 21, 2015��������������������������������������Second quarter results 2015
October 27, 2015������������������������������ Third quarter results 2015
87
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