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Biogen Reports Quarterly Revenues of $3.1 Billion

April 24, 2018 6:59 AM

Total revenues grew 11% or 15% excluding hemophilia revenues*

GAAP diluted EPS increased 60%; Non-GAAP EPS increased 16%

Company adds new Phase 2 program in neuropsychiatry

Company invests in industry leading central nervous system antisense oligonucleotide platform with Ionis Pharmaceuticals

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Biogen Inc. (Nasdaq: BIIB) today reported first quarter 2018 financial results, including:

* In Q1 2017 Biogen completed the spin-off of its global hemophilia business. The 15% increase in total revenues excludes all hemophilia revenues in January 2017. 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) Q1 '18 Q1 '17 Q4 '17

Q1 '18 v.Q1 '17

Q1 '18 v.Q4 '17

Total revenues* $ 3,131 $ 2,811 $ 3,307 11%* (5%)
GAAP net income# $ 1,173 $ 748 $ (297 ) 57% NMF
GAAP diluted EPS $ 5.54 $ 3.46 $ (1.40 ) 60% NMF
Non-GAAP net income# $ 1,282 $ 1,123 $ 1,116 14% 15%
Non-GAAP diluted EPS $ 6.05 $ 5.20 $ 5.26 16% 15%
# Net income attributable to Biogen Inc.
Note: Percent changes represented as favorable/(unfavorable)

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

“We started 2018 well with our first quarter revenues growing 11% versus the prior year, or 15% excluding hemophilia revenues. This is in line with our expectations,” said Michel Vounatsos, Biogen’s Chief Executive Officer. “The fundamentals and resilience of our multiple sclerosis business remained strong, while we experienced anticipated seasonality at the beginning of the year. I believe there is significant opportunity for the future growth of SPINRAZA worldwide as we position Biogen for long-term leadership in spinal muscular atrophy.”

“As pioneers in neuroscience, we continued to advance and expand our portfolio of potential breakthrough treatments for areas of high unmet need. We have added a new Phase 2 asset in our emerging growth area of neuropsychiatry, and we meaningfully enhanced our collaboration with Ionis to develop a new pipeline of gene-based therapies for neurological diseases.”

Revenue Highlights

(In millions) Q1 '18 Q1 '17 Q4 '17

Q1 '18 v.Q1 '17

Q1 '18 v.Q4 '17

Multiple Sclerosis:
TECFIDERA® $ 987 $ 958 $ 1,076 3% (8%)
Total Interferon $ 550 $ 648 $ 645 (15%) (15%)
AVONEX® $ 451 $ 537 $ 520 (16%) (13%)
PLEGRIDY® $ 100 $ 112 $ 125 (11%) (20%)
TYSABRI® $ 462 $ 545 $ 463 (15%) (0%)
FAMPYRATM $ 24 $ 20 $ 24 19% 1%
ZINBRYTA® $ 1 $ 11 $ 12 (87%) (88%)
Spinal Muscular Atrophy
SPINRAZA $ 364 $ 47 $ 363 NMF 0%
Hemophilia*:
ELOCTATE $ $ 48

$

NMF NMF
ALPROLIX $ $ 26 $ NMF NMF
Other Product Revenues:
Biosimilars $ 128 $ 66 $ 122 93% 5%
FUMADERMTM $ 7 $ 10 $ 9 (28%) (21%)
Total Product Revenues: $ 2,523 $ 2,380 $ 2,712 6% (7%)
OCREVUS Royalties $ 77 $ $ 77 NMF (0%)
RITUXAN®/GAZYVA® Revenues $ 366 $ 341 $ 338 7% 8%
Other Revenues $ 164 $ 90 $ 180 83% (8%)
Total Revenues* $ 3,131 $ 2,811 $ 3,307 11%* (5%)
MS Product Revenues + OCREVUS Royalties $ 2,101 $ 2,183 $ 2,296 (4%) (8%)
Note: Numbers may not foot due to rounding; percent changes represented as favorable/(unfavorable)

Expense Highlights

(In millions) Q1 '18 Q1 '17 Q4 '17

Q1 '18 v.Q1 '17

Q1 '18 v.Q4 '17

GAAP cost of sales $ 446 $ 385 $ 509 (16%) 12%
Non-GAAP cost of sales $ 446 $ 385 $ 509 (16%) 12%
GAAP R&D $ 497 $ 423 $ 588 (17%) 15%
Non-GAAP R&D $ 497 $ 421 $ 588 (18%) 15%
GAAP SG&A $ 501 $ 499 $ 572 (1%) 12%
Non-GAAP SG&A $ 497 $

482

$ 554 (3%) 10%

Other Financial Highlights

Business Development Updates

Recent Events

Conference Call and WebcastThe Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:30 a.m. ET on April 24, 2018, 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 second 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. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today 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, MS and 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. 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; 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 the anticipated timing to complete certain transactions. 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. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

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; 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 associated with current and potential future healthcare reforms; problems with our manufacturing processes; risks relating to technology failures or breaches; 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 management and key personnel changes, including attracting and retaining key personnel; risks relating to investment in and expansion of manufacturing capacity for future clinical and commercial requirements; failure to comply with legal and regulatory requirements; fluctuations in our effective tax rate; 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 related to indebtedness; 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; risks relating to the spin-off of our hemophilia business, including risks of operational difficulties and exposure to claims and liabilities; 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 1BIOGEN INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENT OF INCOME(unaudited, in millions, except per share amounts)

For the Three MonthsEnded March 31,

2018 2017
Revenues:
Product, net $ 2,523.5 $ 2,380.1
Revenues from anti-CD20 therapeutic programs 443.2 340.6
Other 164.4 90.0
Total revenues 3,131.1 2,810.7
Cost and expenses:
Cost of sales, excluding amortization of acquired intangible assets 446.0 384.6
Research and development 496.7 423.4
Selling, general and administrative 501.3 498.7
Amortization of acquired intangible assets 103.9 448.5
Collaboration profit (loss) sharing 42.5 20.8
Acquired in-process research and development 10.0
Loss (gain) on fair value remeasurement of contingent consideration (5.6 ) 10.0
Restructuring charges 1.6
Total cost and expenses 1,596.4 1,786.0
Income from operations 1,534.7 1,024.7
Other income (expense), net (41.0 ) (38.0 )
Income before income tax expense and equity in loss of investee, net of tax 1,493.7 986.7
Income tax expense 322.5 239.2
Equity in loss of investee, net of tax
Net income 1,171.2 747.5
Net income (loss) attributable to noncontrolling interests, net of tax (1.7 ) (0.1 )
Net income attributable to Biogen Inc. $ 1,172.9 $ 747.6
Net income per share:
Basic earnings per share attributable to Biogen Inc. $ 5.55 $ 3.47
Diluted earnings per share attributable to Biogen Inc. $ 5.54 $ 3.46
Weighted-average shares used in calculating:
Basic earnings per share attributable to Biogen Inc. 211.4 215.6
Diluted earnings per share attributable to Biogen Inc. 211.7 215.9

TABLE 2BIOGEN INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(unaudited, in millions)

As of March 31,2018 As of December 31,2017
ASSETS
Cash, cash equivalents and marketable securities $ 5,916.0 $ 3,689.0
Accounts receivable, net 1,939.2 1,787.0
Inventory 890.8 902.7
Other current assets 1,449.4 1,494.6
Total current assets 10,195.4 7,873.3
Marketable securities 1,200.2 3,057.3
Property, plant and equipment, net 3,334.7 3,182.4
Intangible assets, net 3,794.5 3,879.6
Goodwill 4,907.8 4,632.5
Investments and other assets

2,657.5

1,027.5

TOTAL ASSETS $

26,090.1

$

23,652.6

LIABILITIES AND EQUITY
Current liabilities $ 3,152.1 $ 3,368.2
Notes payable 5,929.4 5,935.0
Other long-term liabilities 2,971.1 1,751.3
Equity 14,037.5 12,598.1
TOTAL LIABILITIES AND EQUITY $ 26,090.1 $ 23,652.6

TABLE 3BIOGEN INC. AND SUBSIDIARIESGAAP 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
March 31, 2018 March 31, 2017 December 31, 2017
GAAP earnings per share - Diluted $ 5.54 $ 3.46 $ (1.40 )
Adjustments to GAAP net income attributable to Biogen Inc. (as detailed below) 0.51 1.74 6.66
Non-GAAP earnings per share - Diluted $ 6.05 $ 5.20 $ 5.26

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
March 31, 2018 March 31, 2017 December 31, 2017
GAAP net income attributable to Biogen Inc. $ 1,172.9 $ 747.6 $ (297.4 )

Adjustments:

Amortization of acquired intangible assetsA 103.9 448.5 139.8
Acquired in-process research and development 10.0
Loss (gain) on fair value remeasurement of contingent consideration (5.6 ) 10.0 1.5
Net distribution to noncontrolling interestsB 109.7
Hemophilia business separation costs 19.2
Restructuring, business transformation and other cost saving initiatives:
2017 corporate strategy implementationC 3.8 18.5
Restructuring chargesC 1.6 0.9
Loss (gain) on equity security investments 6.4
Income tax effect related to reconciling items (11.3 ) (102.4 ) (30.5 )
Tax reformD 1,173.6
Non-GAAP net income attributable to Biogen Inc. $ 1,281.7 $ 1,122.9 $ 1,116.1
A Amortization of acquired intangible assets includes impairment and amortization charges related to the intangible asset associated with our U.S. and rest of world licenses to Forward Pharma A/S' (Forward Pharma) intellectual property, including Forward Pharma's intellectual property related to TECFIDERA. In exchange for these licenses, we paid Forward Pharma $1.25 billion in cash.

We have two intellectual property disputes with Forward Pharma, one in the U.S. and one in the European Union, concerning intellectual property related to TECFIDERA. In March 2017 the U.S. intellectual property dispute was decided in our favor. We evaluated the recoverability of the U.S. asset acquired from Forward Pharma and recorded an impairment charge in the first quarter of 2017 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. In March 2018 the European Patent Office issued its decision revoking Forward Pharma’s European Patent No. 2 801 355. Based upon our assessment of these rulings, we continue to amortize the remaining net book value of the U.S. and rest of world intangible assets in our condensed consolidated statements of income utilizing an economic consumption model.

B Net distribution to noncontrolling interests for the three months ended December 31, 2017, reflects the after-tax $150.0 million upfront payment made to Neurimmune SubOne AG (Neurimmune) in exchange for a 15% reduction in royalty rates payable on potential commercial sales of aducanumab. This upfront payment is in relation to the amendment of terms of our collaboration agreement with Neurimmune.

C 2017 corporate strategy and restructuring charges are related to our efforts to create a leaner and simpler operating model.

D On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the 2017 Tax Act) was signed into law and has resulted in significant changes to the U.S. corporate income tax system. The 2017 Tax Act includes a federal statutory rate reduction from 35 percent to 21 percent, the elimination or reduction of certain domestic deductions and credits, the transition of U.S. international taxation from a worldwide tax system towards a territorial tax system, limitations on the deductibility of interest expense and executive compensation and base-erosion prevention measures on future non-U.S. earnings of U.S. entities, which has the effect of subjecting certain of our earnings of foreign subsidiaries to U.S. taxation. These changes became effective beginning in 2018.

The 2017 Tax Act also required a one-time mandatory deemed repatriation tax on accumulated foreign subsidiaries’ previously untaxed foreign earnings (the Transition Toll Tax). Changes in tax rates and tax laws are accounted for in the period of enactment. Therefore, during the three months ended December 31, 2017, we recorded a charge totaling $1,173.6 million related to our current estimate of the provisions of the 2017 Tax Act, including a $989.6 million expense under the Transition Toll Tax. The Transition Toll Tax must be paid over an eight-year period, starting in 2018, and will not accrue interest.

Use of Non-GAAP Financial MeasuresWe 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 on February 1, 2017. 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. Loss (gain) on equity security investmentsEffective January 2018, we exclude unrealized and realized gains and losses and discounts or premiums on our equity security investments as we do not believe that these components of income or expense have a direct correlation to our on-going or future business operations.

5. 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 4BIOGEN INC. AND SUBSIDIARIESPRODUCT REVENUES(unaudited, in millions)

For the Three Months Ended
March 31, 2018 March 31, 2017 December 31, 2017
United

States

Rest of

World

Total United

States

Rest of

World

Total United

States

Rest of

World

Total
Multiple Sclerosis (MS):
TECFIDERA $ 728.9 $ 258.0 $ 986.9 $ 751.1 $ 207.1 $ 958.2 $ 831.6 $ 244.0 $ 1,075.6
Interferon* 371.4 178.9 550.3 464.8 183.5 648.3 449.3 195.6 644.9
TYSABRI 249.7 212.4 462.1 305.5 239.5 545.0 252.1 210.6 462.7
FAMPYRA 24.4 24.4 20.5 20.5 24.2 24.2
ZINBRYTA 1.4 1.4 10.7 10.7 11.7 11.7
Spinal Muscular Atrophy:
SPINRAZA 188.0 175.9 363.9 46.4 1.0 47.4 218.2 144.3 362.5
Hemophilia:
ELOCTATE 42.2 6.2 48.4
ALPROLIX 21.0 5.0 26.0
Other Product Revenues:
FUMADERM 7.0 7.0 9.7 9.7 8.9 8.9
BENEPALI 120.9 120.9 65.3 65.3 117.6 117.6
FLIXABI 6.6 6.6 0.6 0.6 4.3 4.3
Total product revenues $ 1,538.0 $ 985.5 $ 2,523.5 $ 1,631.0 $ 749.1 $ 2,380.1 $ 1,751.2 $ 961.2 $ 2,712.4

*Interferon includes AVONEX and PLEGRIDY

Biogen Inc.

Media Contact:

David Caouett, 781-464-3260

or

Investor Contact:

Matt Calistri, 781-464-2442

Source: Biogen Inc.

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