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Biogen Reports Quarterly Revenues of $3.1 Billion

October 24, 2017 6:59 AM

Total revenues grew 4% or 13% excluding hemophilia revenues*

GAAP diluted EPS rise 23%; Non-GAAP diluted EPS rise 22%

Company advances its strategic priorities

Company restructures collaboration arrangements with Eisai and Neurimmune to improve long-term value of aducanumab

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Biogen Inc. (NASDAQ: BIIB) today reported third quarter 2017 financial results, including:

* In Q1 2017, Biogen completed the separation of its global hemophilia business into a new company, known as Bioverativ. The 13% increase in total revenues excludes all hemophilia revenues from Q3 2016. Hemophilia revenues include ELOCTATE® and ALPROLIX® product revenues as well as royalty and contract manufacturing revenue related to Sobi.

(In millions, except per share amounts) Q3 '17 Q2 '17 Q3 '16 Q3 '17 v. Q2 '17 Q3 '17 v. Q3 '16
Total revenues** $ 3,078 $ 3,078 $ 2,956 (0%) 4%**
GAAP net income*** $ 1,226 $ 863 $ 1,033 42% 19%
GAAP diluted EPS $ 5.79 $ 4.07 $ 4.71 42% 23%
Non-GAAP net income*** $ 1,337 $ 1,069 $ 1,138 25% 18%
Non-GAAP diluted EPS $ 6.31 $ 5.04 $ 5.19 25% 22%
** Total revenues grew 13% versus Q3 2016 excluding hemophilia.
***Net income attributable to Biogen Inc.

A reconciliation of GAAP to Non-GAAP quarterly financial results can be found in Table 3 at the end of this press release.

“In the third quarter, we executed well against our strategic priorities,” said Michel Vounatsos, Biogen’s Chief Executive Officer. “Our multiple sclerosis portfolio demonstrated resilience in an increasingly competitive market, and we’re encouraged by the strength of SPINRAZA’s global launch. We had a solid third quarter, and over the balance of the year we anticipate seasonal pressure as well as increased spending as we invest behind our strategic priorities.”

“We believe that our new agreements with Eisai and Neurimmune will improve our long-term economics of aducanumab. We are pleased by Eisai’s decision to exercise their option on aducanumab, demonstrating their confidence in the asset. The region-based profit split with Eisai is designed to leverage each company’s respective geographic strengths and infrastructures.”

Vounatsos continued, “We made important progress advancing our pipeline, including initiating new trials in Alzheimer’s disease and epilepsy and completing enrollment of studies in stroke and Parkinson’s disease. In the next 12 months, we expect data readouts from multiple programs across our core and emerging growth areas.”

Revenue Highlights

(In millions) Q3 '17 Q2 '17 Q3 '16 Q3 '17 v. Q2 '17 Q3 '17 v. Q3 '16
Multiple Sclerosis:
TECFIDERA® $ 1,070 $ 1,111 $ 1,034 (4 %) 3 %
Total Interferon $ 662 $ 691 $ 708 (4 %) (7 %)
AVONEX® $ 538 $ 557 $ 580 (4 %) (7 %)
PLEGRIDY® $ 124 $ 133 $ 128 (7 %) (3 %)
TYSABRI® $ 469 $ 496 $ 515 (5 %) (9 %)
FAMPYRATM $ 24 $ 23 $ 21 7 % 15 %
ZINBRYTA® $ 14 $ 16 $ 2 (11 %) NMF
Spinal Muscular Atrophy
SPINRAZA $ 271 $ 203 $ 34 % NMF
Hemophilia:*
ELOCTATE $ $ $ 132 NMF NMF
ALPROLIX $ $ $ 85 NMF NMF
Other Product Revenues:
Biosimilars $ 101 $ 91 $ 31 12 % 229 %
FUMADERMTM $ 11 $ 10 $ 11 5 % (5 %)
Total Product Revenues: $ 2,623 $ 2,640 $ 2,540 (1 %) 3 %
Anti-CD20 Revenues $ 406 $ 397 $ 318 2 % 28 %
Other Revenues $ 49 $ 42 $ 99 17 % (50 %)
Total Revenues** $ 3,078 $ 3,078 $ 2,956 (0 %) 4%**
Note: Numbers may not foot due to rounding; percent changes represented as favorable/(unfavorable)

Expense Highlights

(In millions) Q3 '17 Q2 '17 Q3 '16 Q3 '17 v. Q2 '17 Q3 '17 v. Q3 '16
GAAP cost of sales $ 370 $ 366 $ 417 (1 %) 11 %
Non-GAAP cost of sales $ 370 $ 366 $ 396 (1 %) 7 %
GAAP R&D $ 446 $ 796 $ 529 44 % 16 %
Non-GAAP R&D $ 446 $ 796 $ 529 44 % 16 %
GAAP SG&A $ 434 $ 430 $ 463 (1 %) 6 %
Non-GAAP SG&A $ 434 $ 430 $ 461 (1 %) 6 %
Note: Percent changes represented as favorable/(unfavorable)

Other Financial Highlights

Collaboration Agreement Updates

Recent Events

Leadership Updates

Conference Call and WebcastThe Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:30 a.m. ET on October 24, 2017, and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least one month.

Note about Future Earnings Releases and CallsStarting with the first quarter 2018 earnings release, Biogen intends to cease publishing press releases relating to future earnings calls, earnings releases, and investor events via newswire services. The Company will post these materials on the Investors section of Biogen’s website, www.biogen.com, and issue a statement on Twitter (@biogen) when they become available.

About BiogenAt Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissman and Nobel Prize winners Walter Gilbert and Phillip Sharp, today Biogen has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics. We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media - Twitter, LinkedIn, Facebook, YouTube.

Safe HarborThis press release contains forward-looking statements, including statements relating to: our strategy and plans; corporate strategy update; potential of our commercial business and pipeline programs; capital allocation and investment strategy; clinical trials and data readouts and presentations; regulatory filings and the timing thereof; anticipated benefits and potential of investments, collaborations, and business development activities; and our future revenues, expenses, and other financial and operating results. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” and other words and terms of similar meaning. You should not place undue reliance on these statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our dependence on sales from our principal products; failure to compete effectively due to significant product competition in the markets for our products; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; risks associated with current and potential future healthcare reforms; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; failure to protect and enforce our data, intellectual property, and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges; uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; risks relating to management and key personnel changes, including attracting and retaining key personnel; problems with our manufacturing processes; our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our control; failure to successfully execute on our growth initiatives; risks relating to investment in and expansion of manufacturing capacity for future clinical and commercial requirements; risks relating to technology failures or breaches; failure to comply with legal and regulatory requirements; fluctuations in our effective tax rate; risks related to indebtedness; the risks of doing business internationally, including currency exchange rate fluctuations; risks related to commercialization of biosimilars; risks related to investment in properties; the market, interest, and credit risks associated with our portfolio of marketable securities; risks relating to stock repurchase programs; risks relating to access to capital and credit markets; risks relating to the spin-off of our hemophilia business, including risks of operational difficulties, exposure to claims and liabilities, and the ability to achieve some or all of the anticipated benefits; environmental risks; risks relating to the sale and distribution by third parties of counterfeit versions of our products; risks relating to the use of social media for our business; change in control provisions in certain of our collaboration agreements; and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the Securities and Exchange Commission.

These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

TABLE 1
BIOGEN INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF INCOME
(unaudited, in millions, except per share amounts)
For the Three MonthsEnded September 30, For the Nine MonthsEnded September 30,
2017 2016

2017

2016

Revenues:
Product, net $ 2,622.5 $ 2,539.6 $ 7,642.3 $ 7,315.0
Revenues from anti-CD20 therapeutic programs 406.5 317.6 1,144.2 996.3
Other 48.8 98.6 180.4 265.5
Total revenues 3,077.8 2,955.8 8,966.9 8,576.8
Cost and expenses:
Cost of sales, excluding amortization of acquired intangible assets 370.0 416.9 1,120.8 1,100.2
Research and development 446.4 529.0 1,666.0 1,439.4
Selling, general and administrative 433.8 462.7 1,363.1 1,452.4
Amortization of acquired intangible assets 108.9 99.7 674.9 281.4
Acquired in-process research and development 120.0
Collaboration profit (loss) sharing 35.2 4.7 82.5 (0.9 )
(Gain) loss on fair value remeasurement of contingent consideration 30.0 5.9 61.2 18.8
Restructuring charges 11.6 21.3
Total cost and expenses 1,424.3 1,530.5 5,088.5 4,312.6
Income from operations 1,653.5 1,425.3 3,878.4 4,264.2
Other income (expense), net (43.6 ) (58.1 ) (149.4 ) (169.4 )
Income before income tax expense and equity in loss of investee, net of tax 1,609.9 1,367.2 3,729.0 4,094.8
Income tax expense 383.8 337.0 892.6 1,047.0
Equity in loss of investee, net of tax
Net income 1,226.1 1,030.2 2,836.4 3,047.8
Net income (loss) attributable to noncontrolling interests, net of tax (2.7 ) (0.1 ) (5.8 )
Net income attributable to Biogen Inc. $ 1,226.1 $ 1,032.9 $ 2,836.5 $ 3,053.6
Net income per share:
Basic earnings per share attributable to Biogen Inc. $ 5.80 $ 4.72 $ 13.32 $ 13.95
Diluted earnings per share attributable to Biogen Inc. $ 5.79 $ 4.71 $ 13.30 $ 13.92
Weighted-average shares used in calculating:
Basic earnings per share attributable to Biogen Inc. 211.4 218.9 213.0 219.0
Diluted earnings per share attributable to Biogen Inc. 211.8 219.4 213.3 219.4
TABLE 2
BIOGEN INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in millions)
As of September 30,2017 As of December 31,2016
ASSETS
Cash, cash equivalents and marketable securities $ 3,508.3 $ 4,895.1
Accounts receivable, net 1,567.5 1,441.6
Inventory 1,007.2 1,001.6
Other current assets 1,485.0 1,393.9
Total current assets 7,568.0 8,732.2
Marketable securities 3,062.0 2,829.4
Property, plant and equipment, net 2,995.9 2,501.8
Intangible assets, net 4,019.4 3,808.3
Goodwill 4,127.5 3,669.3
Investments and other assets 1,300.4 1,335.8
TOTAL ASSETS $ 23,073.2 $ 22,876.8
LIABILITIES AND EQUITY
Current liabilities $ 3,448.4 $ 3,419.9
Notes payable and other financing arrangements 5,938.3 6,512.7
Other long-term liabilities 837.6 815.6
Equity 12,848.9 12,128.6
TOTAL LIABILITIES AND EQUITY $ 23,073.2 $ 22,876.8
TABLE 3
BIOGEN INC. AND SUBSIDIARIES
GAAP TO NON-GAAP RECONCILIATION:
NET INCOME ATTRIBUTABLE TO BIOGEN INC. AND DILUTED EARNINGS PER SHARE
(unaudited, in millions, except per share amounts)

An itemized reconciliation between diluted earnings per share on a GAAP and Non-GAAP basis is as follows:

For the Three Months Ended
September 30, 2017 June 30, 2017 September 30, 2016
GAAP earnings per share - Diluted $ 5.79 $ 4.07 $ 4.71
Adjustments to GAAP net income attributable to Biogen Inc. (as detailed below) 0.52 0.97 0.48
Non-GAAP earnings per share - Diluted $ 6.31 $ 5.04 $ 5.19
For the Nine Months Ended
September 30, 2017 September 30, 2016
GAAP earnings per share - Diluted $ 13.30 $ 13.92
Adjustments to GAAP net income attributable to Biogen Inc. (as detailed below) 3.25 1.26
Non-GAAP earnings per share - Diluted $ 16.55 $ 15.18

An itemized reconciliation between net income attributable to Biogen Inc. on a GAAP and Non-GAAP basis is as follows:

For the Three Months Ended
September 30, 2017 June 30, 2017 September 30, 2016
GAAP net income attributable to Biogen Inc. $ 1,226.1 $ 862.8 $ 1,032.9
Adjustments:
Amortization of acquired intangible assetsA 108.9 117.5 96.7
Acquired in-process research and development 120.0
(Gain) loss on fair value remeasurement of contingent consideration 30.0 21.2 5.9
Hemophilia business separation costs 1.8
Restructuring, business transformation and other cost saving initiatives:
2015 restructuring charges (1.6 )
2016 restructuring charges 13.2
Cambridge manufacturing facility rationalization costsB 21.2
Income tax effect related to reconciling items (27.7 ) (52.4 ) (32.4 )
Non-GAAP net income attributable to Biogen Inc. $ 1,337.3 $ 1,069.1 $ 1,137.7
For the Nine Months Ended
September 30, 2017 September 30, 2016
GAAP net income attributable to Biogen Inc. $ 2,836.5 $ 3,053.6
Adjustments:
Amortization of acquired intangible assetsA 674.9 272.0
Acquired in-process research and development 120.0
(Gain) loss on fair value remeasurement of contingent consideration 61.2 18.8
Hemophilia business separation costs 19.2 5.5
Restructuring, business transformation and other cost saving initiatives:
2015 restructuring charges 8.1
2016 restructuring charges 13.2
Cambridge manufacturing facility rationalization costsB 37.0
Income tax effect related to reconciling items (182.5 ) (78.7 )
Non-GAAP net income attributable to Biogen Inc. $ 3,529.3 $ 3,329.5

A Amortization of acquired intangible assets for the three and nine months ended September 30, 2017, includes $30.4 million and $413.4 million, respectively, of impairment and amortization charges related to the intangible asset associated with our U.S. and rest of world licenses to Forward Pharma’s intellectual property related to TECFIDERA. As we prevailed in the U.S. proceeding in March 2017, we evaluated the recoverability of the U.S. asset acquired from Forward Pharma and recorded an impairment charge to adjust the carrying value of the acquired U.S. asset to fair value reflecting the impact of the developments in the U.S. legal dispute over certain TECFIDERA intellectual property rights. We also continue to amortize the remaining net book value of the U.S. and rest of world licenses in our consolidated statements of income utilizing an economic consumption model.

B Cambridge manufacturing facility rationalization costs for the three and nine months ended September 30, 2016, reflects $15.7 million and $31.5 million, respectively, of additional depreciation expense included in cost of sales, excluding amortization of acquired intangible assets in our condensed consolidated statements of income. Cambridge manufacturing facility rationalization costs for the three and nine months ended September 30, 2016, also includes a charge of $5.5 million for the write-down of excess inventory.

Use of Non-GAAP Financial Measures

We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “Non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these Non-GAAP financial measures provides additional insight into the ongoing economics of our business and reflects how we manage our business internally, set operational goals and forms the basis of our management incentive programs. These Non-GAAP financial measures are not in accordance with generally accepted accounting principles in the United States and should not be viewed in isolation or as a substitute for reported, or GAAP, net income attributable to Biogen Inc. and diluted earnings per share.

Our “Non-GAAP net income attributable to Biogen Inc.” and “Non-GAAP earnings per share - Diluted” financial measures exclude the following items from "GAAP net income attributable to Biogen Inc." and "GAAP earnings per share - Diluted":

1. Purchase accounting and merger-related adjustmentsWe exclude certain purchase accounting related items associated with the acquisition of businesses, assets and amounts in relation to the consolidation or deconsolidation of variable interest entities for which we are the primary beneficiary. These adjustments include, but are not limited to, charges for in-process research and development, the amortization of certain acquired intangible assets, and charges or credits from the fair value remeasurement of our contingent consideration obligations.

2. Hemophilia business separation costsWe have excluded costs that are directly associated with the set up and spin-off of our hemophilia business into an independent, publicly-traded company. These costs represent incremental third party costs attributable solely to hemophilia separation and set up activities.

3. Restructuring, business transformation and other cost saving initiativesWe exclude costs associated with the company’s execution of certain strategies and initiatives to streamline operations, achieve targeted cost reductions, rationalize manufacturing facilities or refocus R&D activities. These costs may include employee separation costs, retention bonuses, facility closing and exit costs, asset impairment charges or additional depreciation when the expected useful life of certain assets have been shortened due to changes in anticipated usage, and other costs or credits that management believes do not have a direct correlation to our on-going or future business operations.

4. Other itemsWe evaluate other items of income and expense on an individual basis, and consider both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to our ongoing business operations, and (iii) whether or not we expect it to occur as part of our normal business on a regular basis. We also include an adjustment to reflect the related tax effect of all reconciling items within our reconciliation of our GAAP to Non-GAAP net income attributable to Biogen Inc. and diluted earnings per share.

TABLE 4
BIOGEN INC. AND SUBSIDIARIES
PRODUCT REVENUES
(unaudited, in millions)
For the Three Months Ended
September 30, 2017 June 30, 2017 September 30, 2016
United

States

Rest of

World

Total United

States

Rest of

World

Total United

States

Rest of

World

Total
Multiple Sclerosis (MS):
TECFIDERA $ 836.3 $ 233.3 $ 1,069.6 $ 875.0 $ 235.6 $ 1,110.6 $ 845.1 $ 188.6 $ 1,033.7
Interferon* 473.3 188.7 662.0 501.7 188.9 690.6 505.7 202.6 708.3
TYSABRI 266.8 202.6 469.4 289.4 206.6 496.0 301.1 214.4 515.5
FAMPYRA 24.3 24.3 22.6 22.6 21.1 21.1
ZINBRYTA 14.2 14.2 16.1 16.1 1.9 1.9
Hemophilia:
ELOCTATE 110.0 21.8 131.8
ALPROLIX 66.7 18.5 85.2
Spinal Muscular Atrophy:
SPINRAZA 197.6 73.3 270.9 194.8 8.1 202.9
Other Product Revenues:
FUMADERM 10.7 10.7 10.3 10.3 11.3 11.3
BENEPALI 99.2 99.2 88.7 88.7 30.7 30.7
FLIXABI 2.2 2.2 1.9 1.9 0.1 0.1
Total product revenues $ 1,774.0 $ 848.5 $ 2,622.5 $ 1,860.9 $ 778.8 $ 2,639.7 $ 1,828.6 $ 711.0 $ 2,539.6
For the Nine Months Ended
September 30, 2017 September 30, 2016
United

States

Rest of

World

Total United

States

Rest of

World

Total
Multiple Sclerosis (MS):
TECFIDERA $ 2,462.4 $ 676.0 $ 3,138.4 $ 2,369.7 $ 596.4 $ 2,966.1
Interferon* 1,439.8 561.1 2,000.9 1,492.2 614.8 2,107.0
TYSABRI 861.7 648.7 1,510.4 894.2 595.7 1,489.9
FAMPYRA 67.4 67.4 62.9 62.9
ZINBRYTA 41.0 41.0 1.9 1.9
Hemophilia:
ELOCTATE 42.2 6.2 48.4 319.0 45.2 364.2
ALPROLIX 21.0 5.0 26.0 194.3 46.2 240.5
Spinal Muscular Atrophy:
SPINRAZA 438.8 82.4 521.2
Other Product Revenues:
FUMADERM 30.7 30.7 34.5 34.5
BENEPALI 253.2 253.2 47.9 47.9
FLIXABI 4.7 4.7 0.1 0.1
Total product revenues $ 5,265.9 $ 2,376.4 $ 7,642.3 $ 5,269.4 $ 2,045.6 $ 7,315.0

*Interferon includes AVONEX and PLEGRIDY

Biogen Inc.

Media Contact:

Matt Fearer, 781-464-3260

or

Investor Contact:

Matt Calistri, 781-464-2442

Source: Biogen Inc.

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