On January 30, 2020 Amgen (NASDAQ:AMGN) reported financial results for the fourth quarter and full year 2019 versus comparable periods in 2018 (Press release, Amgen, JAN 30, 2020, View Source [SID1234553694]). Key results include:

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For the fourth quarter, total revenues decreased 1% to $6.2 billion in comparison to the fourth quarter of 2018, reflecting the impact of biosimilar and generic competition against select products.

Product sales declined 2% globally, while units grew double digits or better for Repatha (evolocumab), Parsabiv (etelcalcetide), BLINCYTO (blinatumomab), Aimovig (erenumab-aooe), Prolia (denosumab), Nplate (romiplostim) and Vectibix (panitumumab).

For the full year, total revenues decreased 2% to $23.4 billion, with product sales decreasing 1%.

GAAP earnings per share (EPS) decreased 5% to $2.85 in the fourth quarter driven by higher operating expenses, offset partially by lower weighted-average shares outstanding. GAAP EPS increased 2% to $12.88 for the full year driven by lower weighted-average shares outstanding, offset partially by lower operating income.

For the fourth quarter, GAAP operating income decreased 14% to $2.0 billion and GAAP operating margin decreased 4.9 percentage points to 34.8%. For the full year, GAAP operating income decreased 6% to $9.7 billion and GAAP operating margin decreased 1.9 percentage points to 43.6%.

Non-GAAP EPS increased 6% in the fourth quarter to $3.64 and 3% to $14.82 for the full year benefited by lower weighted-average shares outstanding. The increase for the full year was offset partially by lower operating income.

For the fourth quarter, non-GAAP operating income decreased 4% to $2.6 billion and non-GAAP operating margin decreased 0.7 percentage points to 44.6%. For the full year, non-GAAP operating income decreased 6% to $11.2 billion and non-GAAP operating margin decreased 2.4 percentage points to 50.2%.

The Company generated $8.5 billion of free cash flow for the full year versus $10.6 billion in 2018.

2020 total revenues guidance of $25.0-$25.6 billion; EPS guidance of $10.85-$11.65 on a GAAP basis and $14.85-$15.60 on a non-GAAP basis.
"We are entering a period of new product driven revenue growth," said Robert A. Bradway, chairman and chief executive officer. "Heading into 2020, our capital allocation priorities are clear, and we look forward to several important clinical data readouts from our innovative pipeline this year."

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations.

Product Sales Performance

Total product sales decreased 2% for the fourth quarter of 2019 versus the fourth quarter of 2018. Product sales decreased 1% for the full year driven by lower net selling price, offset partially by higher unit demand.

Prolia sales increased 15% for the fourth quarter and 17% for the full year driven by higher unit demand.

EVENITY (romosozumab-aqqg) launched in 2019, generating sales of $85 million in the fourth quarter and $189 million for the full year.

Repatha sales increased 26% for the fourth quarter and 20% for the full year driven primarily by higher unit demand, offset partially by net selling price.

Aimovig sales increased 3% for the fourth quarter driven by higher unit demand, offset partially by unfavorable changes in accounting estimates. Full year sales grew 157% driven primarily by unit demand.

Parsabiv sales increased 49% for the fourth quarter and 88% for the full year driven primarily by higher unit demand, offset partially by net selling price.

Otezla (apremilast) was acquired on Nov. 21, 2019, and generated $178 million in sales for the period.

Enbrel (etanercept) sales increased 2% for the fourth quarter and 4% for the full year driven primarily by favorable changes in accounting estimates and higher net selling price, offset partially by lower unit demand.

AMGEVITA (adalimumab) generated $71 million of sales in the fourth quarter and $215 million for the full year.

KYPROLIS (carfilzomib) sales increased 6% for the fourth quarter and 8% for the full year driven by higher unit demand.

XGEVA (denosumab) sales increased 7% for the fourth quarter and 8% for the full year driven primarily by higher unit demand and, to a lesser extent, higher net selling price.

Vectibix sales increased 8% for the fourth quarter and the full year driven by higher unit demand.

Nplate sales increased 15% for the fourth quarter and 11% for the full year driven primarily by higher unit demand.

BLINCYTO sales increased 27% for the fourth quarter and 36% for the full year driven by higher unit demand.

KANJINTI* (trastuzumab-anns) generated $103 million of sales in the fourth quarter and $226 million for the full year.

MVASI* (bevacizumab-awwb) generated $84 million of sales in the fourth quarter and $127 million for the full year.

Neulasta (pegfilgrastim) sales decreased 43% for the fourth quarter and 28% for the full year driven by the impact of biosimilar competition on unit demand and lower net selling price.

NEUPOGEN (filgrastim) sales decreased 17% for the fourth quarter driven by the impact of competition on unit demand. Sales decreased 28% for the full year driven by the impact of competition on unit demand and lower net selling price.

EPOGEN (epoetin alfa) sales decreased 20% for the fourth quarter driven by lower net selling price and unit demand. Sales decreased 14% for the full year driven primarily by lower net selling price.

Aranesp (darbepoetin alfa) sales decreased 10% for the fourth quarter driven by the impact of competition on unit demand and lower net selling price as well as unfavorable changes in inventory. Sales decreased 8% for the full year driven primarily by the impact of competition of unit demand.

Sensipar/Mimpara (cinacalcet) sales decreased 76% for the fourth quarter and 69% for the full year driven by the impact of generic competition on unit demand.

* Registered in the United States.

** Other includes GENSENTA, Bergamo, IMLYGIC and Corlanor.
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:

Total Operating Expenses increased 8% in the fourth quarter and 2% for the full year. Cost of Sales margin increased 3 percentage points in the fourth quarter driven primarily by amortization of intangible assets acquired in the Otezla acquisition. For the full year, Cost of Sales margin increased 1.4 percentage points driven primarily by unfavorable product mix and amortization of intangible assets acquired in the Otezla acquisition, offset partially by lower royalties and lower manufacturing costs. Research & Development (R&D) expenses increased 11% in the fourth quarter and 10% for the full year driven by higher spending in research and early pipeline in support of our oncology programs. The full year was offset partially by lower spend in support of marketed programs. Selling, General & Administrative (SG&A) expenses decreased 3% in the fourth quarter driven by lower spend for launched and marketed products and lower general and administrative expenses, offset partially by Otezla commercial-related expenses. For the full year, SG&A expenses decreased 3% driven by lower general and administrative expenses, the end of certain amortization of intangible assets in 2018 and lower spend for launched and marketed products, offset partially by Otezla commercial-related expenses. Other expenses increased in the fourth quarter driven primarily by restructuring costs in 2019. For the full year, other operating expenses decreased driven primarily by an impairment charge in 2018 of an intangible asset.

Operating Margin decreased 4.9 percentage points in the fourth quarter to 34.8% driven primarily by the Otezla acquisition, and decreased 1.9 percentage points for the full year to 43.6%.

Tax Rate increased 2.3 percentage points in the fourth quarter and 2.1 percentage points for the full year due primarily to a prior-year tax benefit associated with intercompany sales under U.S. corporate tax reform.

On a non-GAAP basis:

Total Operating Expenses increased 2% in the fourth quarter and 3% for the full year. Cost of Sales margin decreased 0.2 percentage points in the fourth quarter. For the full year, Cost of Sales margin increased 0.5 percentage points driven primarily by unfavorable product mix, offset partially by lower royalties and lower manufacturing costs. R&D expenses increased 11% for the fourth quarter and 10% for the full year driven by higher spending in research and early pipeline in support of our oncology programs. The full year was offset partially by lower spend in support of marketed programs. SG&A expenses decreased 2% in the fourth quarter driven by lower spend for launched and marketed products and lower general and administrative expenses, offset partially by Otezla commercial-related expenses. For the full year, SG&A expenses decreased 2% driven by lower general and administrative expenses and lower spend for launched and marketed products, offset partially by Otezla commercial-related expenses.

Operating Margin decreased 0.7 percentage points to 44.6% in the fourth quarter, and decreased 2.4 percentage points to 50.2% for the full year.

Tax Rate increased 1.6 percentage points in the fourth quarter and 1.5 percentage points for the full year due primarily to a prior-year tax benefit associated with intercompany sales under U.S. corporate tax reform.
$Millions, except percentages

Cash Flow and Balance Sheet

The Company generated $2.3 billion of free cash flow in the fourth quarter of 2019 versus $3.0 billion in the fourth quarter of 2018 due primarily to timing of tax payments. The Company generated $8.5 billion of free cash flow for the full year 2019 versus $10.6 billion in 2018 due primarily to unfavorable changes in working capital, an advanced tax deposit and lower net income.

The Company’s fourth quarter 2019 dividend of $1.45 per share was declared on Oct. 22, 2019, and was paid on Dec. 6, 2019, to all stockholders of record as of Nov. 15, 2019, representing a 10% increase from the fourth quarter of 2018. The Company’s first quarter 2020 dividend of $1.60 per share declared on Dec. 11, 2019, will be paid on March 6, 2020, to all stockholders of record as of Feb. 14, 2020, representing a 10% increase from that paid in each of the previous four quarters of 2019.

During the fourth quarter of 2019, the Company repurchased 5.1 million shares of common stock at a total cost of $1.1 billion. For the full year, the Company repurchased 40.2 million shares of common stock at a total cost of $7.6 billion. At the end of the fourth quarter, the Company had $6.5 billion remaining under its stock repurchase authorization.
$Billions, except shares

Note: Numbers may not add due to rounding

2020 Guidance
For the full year 2020, the Company expects:

Total revenues in the range of $25.0 billion to $25.6 billion.

On a GAAP basis, EPS in the range of $10.85 to $11.65 and a tax rate in the range of 10.5% to 11.5%.

On a non-GAAP basis, EPS in the range of $14.85 to $15.60 and a tax rate in the range of 13.5% to 14.5%.

Capital expenditures to be approximately $700 million.
Fourth Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
Otezla

Data from the Phase 3 study in patients with mild-to-moderate psoriasis are expected by mid-year 2020.

A supplemental New Drug Application (sNDA) to expand the Prescribing Information to include data from the Phase 3 scalp psoriasis study is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act target action date in April 2020.

EVENITY

In December 2019, the European Commission (EC) granted marketing authorization for EVENITY for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

KYPROLIS

In January, an sNDA was submitted to the FDA to expand the Prescribing Information to include KYPROLIS in combination with dexamethasone and DARZALEX (daratumumab) for patients with relapsed or refractory multiple myeloma based on data from the Phase 3 CANDOR study.

In November, a marketing authorization application (MAA) was accepted by the China National Medical Products Administration (NMPA) for the use of KYPROLIS plus dexamethasone for the treatment of relapsed and refractory multiple myeloma.

BLINCYTO

In December, the China NMPA granted priority review for the MAA for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia.

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Page 9

AMG 510

A potentially pivotal Phase 2 monotherapy study in advanced non-small cell lung cancer (NSCLC) completed enrollment and data are expected in 2020.

A Phase 2 monotherapy study is enrolling advanced colorectal cancer patients.

A Phase 1b study in combination with MEK inhibition is enrolling advanced colorectal and non-small cell lung cancer patients.

The ongoing Phase 1 monotherapy study is also enrolling treatment naïve NSCLC patients.

In 2020, additional data are expected from the first-in-human monotherapy study in patients with multiple solid tumors, and initial data are expected from a Phase 1 study in combination with KEYTRUDA (pembrolizumab) in patients with advanced NSCLC.

In January, the Company announced strategic collaborations with leading diagnostic companies, Guardant Health, Inc. and QIAGEN N.V., to develop blood- and tissue-based companion diagnostics, respectively.

Omecamtiv mecarbil

Data from the event driven Phase 3 GALACTIC-HF cardiovascular outcomes study are expected in Q4 2020.

AVSOLA (infliximab-axxq)

In December, the FDA approved AVSOLA for all approved indications of the reference product, Remicade (infliximab).

ABP 798 (biosimilar rituximab)

In December, a Biologics License Application was submitted to the FDA for ABP 798, a biosimilar candidate to Rituxan (rituximab).

On January 30, 2020 FORMA Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the achievement of clinical development milestones for two of its exclusively-licensed, clinical-stage products to Boehringer Ingelheim (BI) and Bristol-Myers Squibb Company (BMS) (NYSE:BMY) (Press release, Forma Therapeutics, JAN 30, 2020, View Source [SID1234553692]).

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BI initiated a Phase 1 clinical trial for BI 1701963, a SOS1:KRAS inhibitor discovered in a partnership with FORMA that targets protein-protein interactions for the treatment of cancer. KRAS mutations occur in one in seven of all human metastatic cancers, making it the most frequently mutated cancer-causing oncogene. The selective inhibition of SOS1 is a therapeutic concept that could allow KRAS blockade irrespective of KRAS mutation type. In 2011, BI 1701963 was exclusively licensed to Boehringer Ingelheim, who is leading the program’s development. Financial terms are undisclosed. Preclinical data regarding the discovery and development of BI 1701963 was presented by BI at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October 2019.

BMS initiated an open-label, Phase 1B dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-95775 (formerly FT-1101) in patients with advanced or unresectable solid tumors. CC-95775 is a pan-BET bromodomain inhibitor that was discovered under a partnership between FORMA and Celgene and exclusively licensed to Celgene in 2018. BMS is responsible for further development, and FORMA is eligible to receive potential milestone payments plus royalties for this and another asset based upon development, regulatory and sales objectives. FORMA recently presented data from a Phase 1 study of CC-95775 as a single agent in patients with relapsed or refractory hematologic malignancies at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper).

Frank Lee, CEO of FORMA said, "FORMA has a deep history of collaboration, and I’m excited about the achievement of these clinical milestones announced today. Our partnership with BI was among the early drug discovery initiatives focused on difficult-to-drug protein-protein interactions in cancer. We are gratified to see this pan-KRAS inhibitor, which BI licensed following early discovery work by FORMA, advance into the clinic and potentially offer a much-needed new therapy for patients with limited treatment options."

"In addition, our broad, multi-year collaboration with Celgene, since acquired by BMS, has yielded several novel candidates and valuable intellectual property, which is reflected in BMS’ and FORMA’s development pipelines. We are pleased to see the pan-BET inhibitor CC-95775 continue to advance in clinical studies with the potential to benefit patients with unresectable solid tumors," Mr. Lee concludes.

On January 30, 2020 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a conference call and webcast in conjunction with its fourth quarter/year end 2019 update and financial results on Thursday, February 13 at 8:30 a.m. ET (Press release, Acorda Therapeutics, JAN 30, 2020, View Source [SID1234553691]).

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To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 4665685. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on February 13, 2020 until 11:59 p.m. ET on March 12, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4665685. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On January 30, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will host a conference call and live webcast on Thursday, February 13, 2020 at 8:00 a.m. ET to report its fourth quarter and full year 2019 financial results and other business highlights (Press release, Agios Pharmaceuticals, JAN 30, 2020, https://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-fourth-quarter-and-full-year-2019 [SID1234553690]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 4195413. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.

On January 30, 2020 Biogen Inc. (Nasdaq: BIIB) reported full year and fourth quarter 2019 financial results (Press release, Biogen, JAN 30, 2020, View Source [SID1234553689]).

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"In 2019 Biogen demonstrated strong execution across all of our core business areas with resilience in MS, continued strong worldwide growth for SPINRAZA, and an expanded biosimilars business," said Michel Vounatsos, Biogen’s Chief Executive Officer. "In addition, as part of our expanded pipeline, we are excited about the prospects for aducanumab in Alzheimer’s disease and look forward to completing a regulatory filing in the U.S. as soon as possible."

Financial Results

Full year total revenues were $14,378 million, a 7% increase versus the prior year, driven by growth in all of the Company’s core business areas.

Full year multiple sclerosis (MS) revenues, including $688 million in royalties on the sales of OCREVUS, increased 2% versus the prior year to $9,217 million.◦

Full year SPINRAZA revenues increased 22% versus the prior year to $2,097 million.

Full year biosimilars revenues increased 35% to $738 million.

Full year GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $5,889 million and $31.42, respectively, compared to $4,431 million and $21.58, respectively, in the prior year.

Full year Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $6,291 million and $33.57, respectively, compared to $5,378 million and $26.20, respectively, in the prior year.

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

Mr. Vounatsos added, "Our pipeline has grown and is maturing, as we added 7 new clinical programs in 2019 and expect 11 mid- to late-stage data readouts by the end of 2021. We look forward to multiple near-term opportunities for value creation, including in Alzheimer’s disease, ALS, stroke, lupus, ophthalmology, and biosimilars, as we aim to build a multi-franchise portfolio. Across all areas of investment, we remain focused on diligent capital allocation to maximize returns for our shareholders over the long term."

In the fourth quarter of 2019 channel inventory levels in the U.S. increased by approximately $135 million for TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, and TYSABRI combined. This compares to a decrease of approximately $30 million in the third quarter of 2019 and an increase of approximately $105 million in the fourth quarter of 2018.

In the fourth quarter of 2019 SPINRAZA revenues comprised $243 million in sales in the U.S. and $300 million in sales outside the U.S. The number of commercial patients receiving SPINRAZA grew approximately 2% in the U.S. and approximately 10% outside the U.S. versus the third quarter of 2019.

Note: Percent changes represented as favorable/(unfavorable)

R&D expense in the fourth quarter of 2019 included $63 million related to the transaction completed in December 2019 with Samsung Bioepis Co., Ltd. (Samsung Bioepis).

R&D expense in the fourth quarter of 2019 included $45 million related to the option exercise with Ionis Pharmaceuticals, Inc. (Ionis) to develop and commercialize BIIB080, an antisense oligonucleotide targeting tau, for Alzheimer’s disease and potentially other tauopathies.

R&D expense in the fourth quarter of 2019 included $30 million related to collaboration agreements with CAMP4 Therapeutics and Catalyst Biosciences, Inc.

SG&A expense in the fourth quarter of 2019 increased versus the third quarter of 2019 primarily due to increased commercial and medical investments as well as the timing of spend on general and administrative expense.
Other Financial Highlights

For 2019 GAAP other income was $83 million, and Non-GAAP other expense was $110 million. The difference between 2019 GAAP and Non-GAAP other income (expense) was primarily due to GAAP-only gains on strategic investments recognized in 2019. For the fourth quarter of 2019 GAAP other expense was $49 million, and Non-GAAP other expense was $50 million.

For 2019 the Company’s effective full year GAAP and Non-GAAP tax rates were 16.3% and 15.8%, respectively. For the fourth quarter of 2019 the Company’s effective GAAP and Non-GAAP tax rates were 16.0% and 16.1%, respectively.

Compared to the prior year, the Company’s effective GAAP and Non-GAAP tax rates for both the full year and fourth quarter of 2019 benefitted from a non-recurring change in the Company’s tax profile in 2019 and the sale of the remaining portion of higher taxed inventory in 2018 due to intercompany effects. Furthermore, compared to the prior year, the Company’s effective GAAP tax rates for both the full year and fourth quarter of 2019 also benefitted from the unfavorable effects of U.S. tax reform in 2018.

Throughout 2019 Biogen repurchased approximately 23.6 million shares of the Company’s common stock for a total value of $5,868 million, including approximately 7.7 million shares repurchased in the fourth quarter of 2019 for a total value of $2,093 million.

As of December 31, 2019, there was $1,279 million remaining under the share repurchase program authorized in March 2019.

In December 2019 Biogen’s Board of Directors authorized an additional program to repurchase up to $5,000 million of the Company’s common stock.

As of December 31, 2019, Biogen had cash, cash equivalents, and marketable securities totaling $5,884 million, and $5,955 million in notes payable and other financing arrangements.

The Company generated approximately $7,079 million in net cash flows from operations in 2019, including approximately $1,960 million in the fourth quarter of 2019.

For 2019 the Company’s full year weighted average diluted shares were 187 million. For the fourth quarter of 2019 the Company’s weighted average diluted shares were 178 million.

2020 Financial Guidance
Biogen also announced its full year 2020 financial guidance. This financial guidance consists of the following components:

Revenue is expected to be approximately $14.0 billion to $14.3 billion.

GAAP and Non-GAAP R&D expense is expected to be approximately 15% to 16% of total revenue.

GAAP and Non-GAAP SG&A expense is expected to be approximately 19.5% to 20.5% of total revenue.

GAAP and Non-GAAP tax rate is expected to be approximately 18% to 19%.

GAAP diluted EPS is expected to be between $29.50 and $31.50.

Non-GAAP diluted EPS is expected to be between $31.50 and $33.50.
This financial guidance does not include any impact from potential acquisitions or large business development transactions, as both are hard to predict. This financial guidance assumes no generic competition in the U.S. for TECFIDERA in 2020 and no change to foreign exchange rates. This financial guidance assumes additional commercial and R&D expenses related to aducanumab, closing of the proposed transaction with Pfizer Inc., and a stable share count.
Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2020 that could cause actual results to vary from this financial guidance.

Recent Events

In January 2020 Biogen announced an agreement to acquire from Pfizer PF-05251749, a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases. In particular, Biogen plans to develop the Phase 1 asset for the treatment of sundowning in Alzheimer’s disease and irregular sleep wake rhythm disorder in Parkinson’s disease. The purchase will include an upfront payment of $75 million with up to $635 million in potential additional development and commercialization milestone payments, as well as tiered royalties in the high single digits to sub-teens. This transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S., and is expected to close in the first quarter of 2020.

In 2019 Biogen added seven clinical programs to its pipeline, including BIIB111 (timrepigene emparvovec) for choroideremia (CHM), BIIB112 (RPGR gene therapy) for X-linked retinitis pigmentosa, BIIB091 (BTK inhibitor) for MS, BIIB094 (ION859) for Parkinson’s disease, BIIB100 (XPO1 inhibitor) for amyotrophic lateral sclerosis, BIIB093 (glibenclamide IV) for brain contusion, and SB11, a biosimilar referencing LUCENTIS.

In December 2019 Biogen entered into a collaboration agreement with CAMP4 Therapeutics. The collaboration will leverage CAMP4 Therapeutics’ Gene Circuitry PlatformTM with the aim of identifying how to dial up or down the expression of disease-associated genes within microglial cells – the primary immune cells of the central nervous system, which are implicated in many serious neurological and neurodegenerative diseases. Under the terms of the agreement, Biogen paid CAMP4 Therapeutics an upfront payment of $15 million.

In December 2019 Biogen entered into a global license and collaboration agreement with Catalyst Biosciences for the development and commercialization of pegylated CB 2782, a preclinical anti-C3 protease, for the potential treatment of geographic atrophy associated dry age-related macular degeneration. Under the terms of the agreement, Biogen paid Catalyst Biosciences an upfront payment of $15 million.

In December 2019 Biogen completed a transaction with Samsung Bioepis and secured the exclusive rights to commercialize two new potential ophthalmology biosimilars, SB11 referencing Lucentis and SB15 referencing Eylea, in major markets worldwide, including the U.S., Canada, Europe, Japan, and Australia. In addition, Biogen acquired exclusive commercialization rights for its anti-TNF portfolio, including BENEPALI, FLIXABI, and IMRALDI, in China. Biogen also acquired an option to extend its existing commercial agreement with Samsung Bioepis for this anti-TNF portfolio in Europe.

In December 2019 Biogen announced topline results from the Phase 2 PASSPORT study of gosuranemab (BIIB092) for progressive supranuclear palsy (PSP). The primary endpoint, as measured by the PSP rating scale at week 52, was not statistically significant. In addition, the study did not demonstrate efficacy on key clinical secondary endpoints. Safety results of the PASSPORT study were generally consistent with previous studies of gosuranemab. Based on these results, Biogen discontinued development of gosuranemab for PSP and other primary tauopathies.

In December 2019 Biogen presented topline data from the aducanumab Phase 3 EMERGE and ENGAGE studies at the Clinical Trials on Alzheimer’s Disease (CTAD) annual congress in San Diego, California.

In December 2019 Biogen announced positive top-line results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells, in patients with lupus. LILAC was a two-part study that evaluated BIIB059 versus placebo in individuals with active cutaneous lupus erythematosus (CLE), including chronic and subacute subtypes, with or without systemic manifestations and in individuals with systemic lupus erythematosus (SLE) with active joint and skin manifestations. Both the CLE and SLE parts of the study met the primary endpoints. The safety and tolerability profile of BIIB059 supports its continued development, and Biogen plans to advance BIIB059 to Phase 3.

In November 2019 Biogen presented detailed results from the Phase 3 EVOLVE-MS-2 study of VUMERITY (diroximel fumarate) at the 27th Annual Meeting of the European Charcot Foundation in Italy. VUMERITY is a novel oral fumarate with a distinct chemical structure, and the EVOLVE-MS-2

results demonstrated improved patient-assessed gastrointestinal (GI) tolerability as compared to TECFIDERA (dimethyl fumarate).

In November 2019 Biogen completed enrollment in the global Phase 3 STAR clinical study, which is evaluating the investigational gene therapy BIIB111 for the potential treatment of CHM. CHM is a rare, degenerative, X-linked inherited retinal disorder that leads to blindness and currently has no approved treatments.

In October 2019 the U.S. Food and Drug Administration approved VUMERITY for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.In October 2019 Biogen announced that it plans to submit a regulatory filing for aducanumab in Alzheimer’s disease based on a new analysis of a larger dataset from the Phase 3 EMERGE and ENGAGE studies.

Conference Call and Webcast
The Company’s earnings conference call for the fourth quarter will be broadcast via the internet at 8:00 a.m. ET on January 30, 2020, 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.