SOD1-ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS affecting less than 1,000 people in Europe1With QALSODY, Biogen has advanced the role of neurofilament in the development of new medicines for ALS, with the potential to accelerate further discovery in the field CAMBRIDGE, Mass., Feb. 23, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommend ...

Revenue and Product Performance - TECFIDERA, TYSABRI, and SPINRAZA each accounted for over 10.0% of total revenue for the years ended December 31, 2023, 2022, and 2021[48]. - Two wholesale distributors accounted for over 10.0% of total revenue, combined accounting for approximately 36.9%, 37.9%, and 38.9% of gross product revenue for the years ended December 31, 2023, 2022, and 2021, respectively[70]. - TECFIDERA's revenue has been significantly reduced due to generic competition, and future revenue is expected to continue declining[89]. - The commercialization of competing products, such as ZOLGENSMA and EVRYSDI, is anticipated to adversely affect sales of SPINRAZA in the spinal muscular atrophy market[92]. - LEQEMBI and SKYCLARYS are in the early stages of commercial launch in the U.S., with potential revenue impacted by reimbursement challenges and competition[185]. Collaborations and Acquisitions - The company terminated its collaboration and license agreement with Neurimmune for ADUHELM in November 2023[52]. - The acquisition of Reata in September 2023 included SKYCLARYS for Friedreich's ataxia (FA)[55]. - The collaboration with Eisai for LEQEMBI involves equal sharing of costs and profits, with a ten-year supply agreement for manufacturing[102]. - The company has a global collaboration with Sage Therapeutics for zuranolone, sharing development costs and profits in the U.S., with potential tiered royalties outside the U.S.[103]. - The company has entered into a collaboration with Denali to co-develop small molecule inhibitors for Parkinson's disease, sharing development costs and profits in the U.S. and China[107]. Intellectual Property and Regulatory Matters - The company regularly seeks patent protection for inventions from its research and development efforts[71]. - The patent portfolio includes key patents for marketed products, with expected expiration dates ranging from 2024 to 2035, ensuring continued market exclusivity[74]. - TECFIDERA's patent in Europe is set to expire in 2024, while its regulatory exclusivity is expected until 2025[81]. - The company continues to pursue additional patents and extensions to enhance product exclusivity beyond current expirations[74]. - Regulatory data protection and market protection are critical for maintaining competitive advantage in the pharmaceutical market[73]. Competition and Market Challenges - The introduction of generic versions and biosimilars in the multiple sclerosis (MS) market is expected to significantly reduce the price and volume of existing products, negatively impacting revenue[87]. - The company faces intense competition in the biopharmaceutical industry, with competitors having greater financial and technological resources[86]. - Biosimilar competition for RITUXAN has led to a substantial decrease in sales and profits from collaboration arrangements with Genentech[94]. - The company is aware of other products in development that may compete with its existing products, which could further impact future sales[92]. - The company’s ability to maintain pricing and market share is threatened by the introduction of new products and generics, which could lead to reduced revenue[192]. Financial Performance and Investments - Working capital decreased to $3.4 billion as of December 31, 2023, from $6.5 billion a year earlier, reflecting a decrease in total current assets by approximately $2,931.9 million and an increase in total current liabilities by approximately $161.5 million[351]. - Cash, cash equivalents, and current marketable securities decreased by $3,842.9 million primarily due to the acquisition of Reata and early repayment of $350.0 million in debt obligations related to this acquisition[352]. - Net cash flow provided by operating activities increased by 11.8% to $1,547.2 million in 2023 compared to $1,384.3 million in 2022[357]. - Long-term debt outstanding was $6,788.2 million as of December 31, 2023, including $650.0 million under the 2023 Term Loan[362]. - The company repurchased approximately 3.6 million shares at a cost of $750.0 million under its share repurchase program in 2022, with $2.1 billion remaining available as of December 31, 2023[364]. Regulatory Compliance and Risks - The company is subject to stringent FDA regulations regarding product approval and changes, which may require additional clinical trials and significant expenditures[116]. - The company is subject to civil monetary penalties if it fails to provide timely information or submits false information regarding Medicaid and Medicare pricing[129]. - The company faces significant risks related to compliance with international laws and regulations, which may vary significantly across different markets[213]. - The company is subject to extensive government regulation, and violations could result in criminal and civil sanctions, including fines and exclusion from government programs[212]. - The company may incur substantial costs related to compliance with evolving legal and regulatory requirements in the healthcare industry, which could impact its business practices[209]. Corporate Governance and Workforce - As of December 31, 2023, the company had approximately 7,570 employees worldwide, with 4,140 in the U.S. and 3,430 in foreign countries[152]. - 31.2% of manager-level and above positions in the U.S. were held by ethnic or racial minorities, while 48.6% of director-level and above positions globally were held by women[153]. - The company has integrated ESG oversight into its Board of Directors' governance principles, with a focus on advancing ESG efforts tied to employee compensation[147]. - The company has conducted a talent review to manage succession plans for critical roles, ensuring long-term continuity of the business[159]. - The company has refreshed its flexible working arrangement policies to better support employees' work-life balance[158]. Management and Leadership - Mr. Viehbacher has been the President and CEO of Biogen since November 2022, previously serving as Managing Partner at Gurnet Point Capital and Global CEO of Sanofi[169]. - Ms. Alexander has been the Chief Legal Officer since April 2018, with prior roles including Executive Vice President of Legal and Corporate Services[170]. - Mr. McDonnell has served as CFO since August 2020, previously holding CFO positions at IQVIA and Intelsat[172]. - Ms. Murphy has been the Executive Vice President of Pharmaceutical Operations and Technology since February 2022, previously leading Global Manufacturing & Technical Operations[173]. - Dr. Singhal has been the Executive Vice President and Head of Development since January 2023, with a history at Biogen and Vertex Pharmaceuticals[177].

Biogen Inc. (NASDAQ:BIIB) Q4 2023 Earnings Conference Call February 13, 2024 8:00 AM ET Company Participants Chuck Triano - Head of Investor Relations Chris Viehbacher - President and Chief Executive Officer Priya Singhal - Head of Development Mike McDonnell - Chief Financial Officer Conference Call Participants Marc Goodman - Leerink Partners Salveen Richter - Goldman Sachs Umer Raffat - Evercore ISI Evan Seigerman - BMO Capital Markets Phil Nadeau - TD Cowen Michael Yee - Jefferies Colin Bristow - UBS Chr ...

Biogen (BIIB) reported fourth-quarter 2023 adjusted earnings per share (EPS) of $2.95, which missed the Zacks Consensus Estimate of $3.16. Earnings declined 27% year over year. On a constant currency basis, earnings were flat.Total revenues came in at $2.39 billion, down 6% on a reported basis (5% on a constant-currency basis) from the year-ago quarter due to lower sales of all key drugs, multiple sclerosis (MS) drugs like Tecfidera and Tysabri as well as spinal muscular atrophy drug, Spinraza. Sales missed ...

Biogen Inc. (BIIB) reported $2.39 billion in revenue for the quarter ended December 2023, representing a year-over-year decline of 6.2%. EPS of $2.95 for the same period compares to $4.05 a year ago.The reported revenue represents a surprise of -2.88% over the Zacks Consensus Estimate of $2.46 billion. With the consensus EPS estimate being $3.16, the EPS surprise was -6.65%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine ...

Biogen Inc. (BIIB) came out with quarterly earnings of $2.95 per share, missing the Zacks Consensus Estimate of $3.16 per share. This compares to earnings of $4.05 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -6.65%. A quarter ago, it was expected that this company would post earnings of $3.99 per share when it actually produced earnings of $4.36, delivering a surprise of 9.27%.Over the last four quarters, the company has s ...

Q4 and Full Year 2023 Financial Results and Business Update Non-GAAP financial information This presentation and the discussions during this conference call include certain financial measures that were not prepared in accordance with accounting principles generally accepted in the U.S. (GAAP), including adjusted net income, adjusted diluted earnings per share, revenue growth at constant currency, which excludes the impact of changes in foreign exchange rates and hedging gains or losses, and free cash flow, ...

Biogen on Tuesday reported fourth-quarter revenue and profit that shrank from a year ago, as it recorded charges related to dropping its controversial Alzheimer's drug Aduhelm and as sales slumped in its multiple sclerosis therapies, the company's biggest drug category.Biogen booked sales of $2.39 billion for the quarter, down 6% from the same period a year ago. Revenue from multiple sclerosis products fell 8% to $1.17 billion as the therapies face competition from cheaper generics. The results come as the ...

Friedreich's ataxia is a rare, genetic, life-shortening, debilitating, and neurodegenerative disorderTreatment with SKYCLARYS improved patient function compared to placeboBiogen is leveraging its expertise and capabilities in rare disease to bring this groundbreaking treatment to patients CAMBRIDGE, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) --  Biogen Inc. (NASDAQ:BIIB) announced the European Commission (EC) has authorized SKYCLARYS® (omaveloxolone) for the treatment of Friedreich's ataxia (FA) in adults and ad ...

We expect Biogen (BIIB) to beat expectations when it reports fourth-quarter and full-year 2023 results on Feb 13, before market open. In the last reported quarter, the company delivered an earnings surprise of 9.27%.Factors to ConsiderBiogen’s sales in the fourth quarter are likely to have been hurt by lower sales of its multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and rising competitive pressure in the MS market. Tecfidera sales have been declining as multiple generic versions of the drug hav ...