Financial Performance - Total revenue increased by 7% year-over-year to $265 billion[53] - Launch products generated $252 million in revenue, a 26% increase quarter-over-quarter and a 91% increase year-over-year[53] - Non-GAAP diluted EPS increased by 4% year-over-year to $547[53] - The company generated $134 million of free cash flow, which includes a $745 million impact from Q2 2025 tax payments[53] - The company expects full-year 2025 Non-GAAP diluted EPS between $1550 and $1600, up from the previous guidance of $1450 to $1550[53] - The company expects full-year 2025 total revenue to be approximately flat at constant currency versus FY 2024, an increase from a mid-single-digit decline previously[53] Product Performance - SKYCLARYS worldwide sales reached $130 million in Q2, up 30% year-over-year and 5% quarter-over-quarter[47] - SKYCLARYS U S sales were $78 million, up 3% year-over-year and 13% quarter-over-quarter[47] - ZURZUVAE U S sales were $46 million in Q2, up 213% year-over-year and 68% quarter-over-quarter[48] - LEQEMBI worldwide sales were $160 million in Q2, excluding $35 million in stocking in China; U S sales increased 20% quarter-over-quarter to $63 million[49] Pipeline and Development - Phase 3 studies were initiated for felzartamab in IgAN and PMN, and for SKYCLARYS in pediatric FA[18] - Positive Phase 1b results for salanersen support moving to registrational status for SMA, with a Phase 3 study expected to start by early 2026[18,32] - New analyses of dapirolizumab pegol Phase 3 data in SLE show improvement in fatigue and reduction in disease activity[18]

Financial Performance - Biogen raised its full-year financial guidance [1] - The company beat Wall Street's expectations [1] Product Performance - Growing sales of Biogen's Alzheimer's drug contributed to the positive financial results [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 0-19311 BIOGEN INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 33-0112644 (I.R.S. Employer Ide ...

Core Viewpoint - Analysts forecast a significant decline in Biogen Inc.'s quarterly earnings and revenues, indicating potential challenges for the company in the upcoming earnings release [1][2]. Financial Performance Estimates - Expected earnings per share (EPS) for Biogen is $3.94, reflecting a year-over-year decline of 25.4% [1]. - Anticipated revenues are projected at $2.32 billion, which is a decrease of 5.8% compared to the same quarter last year [1]. Revisions and Trends - Over the past 30 days, the consensus EPS estimate has been revised downward by 2.7%, indicating a shift in analysts' expectations [2]. - Changes in earnings estimates are crucial for predicting investor reactions, as empirical studies show a strong correlation between earnings estimate revisions and short-term stock performance [3]. Product Revenue Estimates - Revenue from the product TYSABRI for Multiple Sclerosis is estimated at $372.66 million, down 19.4% year-over-year [5]. - Revenue from SPINRAZA for Rare Disease is projected at $396.92 million, indicating a decline of 7.5% year-over-year [5]. - SKYCLARYS for Rare Disease is expected to generate $128.37 million, showing a year-over-year increase of 28.4% [5]. Detailed Product Revenue Breakdown - Total net product revenue is estimated to be $1.72 billion, reflecting a year-over-year decrease of 9.5% [6]. - TYSABRI revenue in the United States is projected at $203.91 million, down 18% year-over-year [6]. - Revenue from TECFIDERA in the United States is expected to be $32.02 million, indicating a decline of 27.4% year-over-year [7]. Additional Revenue Insights - SPINRAZA revenue from the Rest of World is estimated at $244.01 million, down 10.2% from the previous year [8]. - Revenue from SPINRAZA in the United States is projected at $156.29 million, showing a slight decline of 0.6% year-over-year [8]. - Revenue from Interferon products in the United States is expected to be $129.57 million, reflecting a decrease of 10.9% year-over-year [9]. Stock Performance - Over the past month, Biogen's shares have decreased by 1.7%, contrasting with a 3.4% increase in the Zacks S&P 500 composite [10]. - Biogen currently holds a Zacks Rank 3 (Hold), suggesting its performance may align with the overall market in the near future [10].

Core Viewpoint - The development of Alzheimer's drugs is facing significant bottlenecks, with Biogen and Eli Lilly maintaining a leading position in the market. However, due to research setbacks, safety risks, and slow adoption, the market size forecast for 2030 has been drastically reduced to $6 billion from a previous expectation of $13 billion [3][4]. Group 1: Market Forecast and Sales Predictions - The combined sales of Biogen's Leqembi and Eli Lilly's Kisunla are projected to reach $5.91 billion by 2025, with potential growth to $40 billion by 2030, which is 24% lower than the market's general expectation of $50 billion due to slow drug adoption [4]. - By 2030, the total sales of Alzheimer's drugs are expected to reach $6 billion, with nearly $1 billion coming from new mechanism drugs [5]. Group 2: Impact of Research Failures - A series of late-stage clinical trial failures have led to a 54% reduction in sales forecasts for Alzheimer's drugs since June 2024, with risk-adjusted sales expectations shrinking by over $7 billion for 2025-2030, including a $3 billion reduction for 2030 alone [8][11]. - The decline in sales expectations is attributed to the exit of several late-stage candidates from the market due to research failures or lowered priorities [8]. Group 3: Competitive Landscape - The long-term administration of Leqembi shows limited cognitive improvement, particularly in patients with low or no tau pathology, which affects about 40% of the trial population. This has led to skepticism among physicians and patients regarding the drug's efficacy [11]. - New candidates, such as Novo Nordisk's semaglutide and Roche's trontinemab, are expected to increase competitive pressure, potentially limiting the market share of first-generation amyloid-beta antibodies [11][15]. Group 4: Company-Specific Insights - Biogen's Leqembi faces increasing risks due to limited application, with sales forecasts for 2030 being 20% lower than market expectations, driven by safety concerns and access barriers [13]. - Eli Lilly is expected to surpass Biogen in sales by 2029, driven by the approval of Kisunla and subsequent antibody drugs, indicating a shift in market leadership [15].

Core Viewpoint - Biogen is expected to report second-quarter 2025 results on July 31, with sales and earnings estimates at $2.32 billion and $3.95 per share, respectively, following a previous earnings miss of 7.4% [1][11]. Group 1: Sales Performance - Lower sales of Biogen's multiple sclerosis (MS) drugs are anticipated, likely offset by revenue growth from new products [2]. - Sales of Tecfidera and Tysabri are projected to decline due to generic and biosimilar competition, with estimates for Tecfidera at $178.0 million and Tysabri at $373.0 million [3][4]. - Vumerity's sales are expected to rise, with estimates at $70.0 million and $181.9 million [4]. - Spinraza's sales are estimated at $397.0 million and $403.0 million, with a potential reversal in favorable shipment timing impacting second-quarter results [5]. - Skyclarys is likely to see mixed dynamics in the U.S. and global markets, with growth driven more by ex-U.S. sales [6][9]. Group 2: Collaborations and New Products - Biogen's collaboration with Sage Therapeutics for Zurzuvae involves shared profits and losses, with strong patient demand expected to continue [7]. - Alzheimer's collaboration revenues, including Biogen's share from Leqembi, are expected to rise, with Leqembi's sales improving sequentially [8][10]. Group 3: Earnings Expectations - Biogen's earnings surprise history shows a mixed performance, with a four-quarter average surprise of 8.36% [11]. - The Earnings ESP for Biogen is -0.85%, indicating a lower likelihood of an earnings beat this quarter [14].

Investment Rating - The report maintains a "Positive" outlook for the pharmaceutical and biotechnology industry in China [6]. Core Insights - Small nucleic acid drugs are expected to become the third major class of drugs after small molecules and antibodies, with unique advantages such as broad targets, strong specificity, high development efficiency, and long dosing intervals [9][38]. - The commercialization of rare diseases is maturing, and the long-term advantages for chronic diseases are becoming evident, with significant sales growth for products like Spinraza and Leqivo [9][60]. - There is a notable increase in business development (BD) activities, highlighting the potential of early-stage chronic disease pipelines [9]. Summary by Sections 1. Small Nucleic Acids: Potential as a New Drug Class - Small nucleic acid drugs, including ASO, siRNA, and Aptamer, interact with mRNA to regulate gene expression, offering a new technological pathway for drug development [13]. - The global market for small nucleic acid drugs has grown from $1.04 billion in 2017 to $5.09 billion in 2024, with a CAGR of 25.5% [60]. 2. Milestones in Overseas and Domestic Markets - In the overseas market, significant developments are expected in the TTR field and cardiovascular diseases, with drugs like Vutrisiran and Pelacarsen showing promise [9]. - In China, new therapies for chronic hepatitis B and competitive advancements in cardiovascular drugs are emerging, with several companies making progress in their pipelines [9][60]. 3. Investment Recommendations and Targets - The report suggests focusing on high-quality domestic companies involved in the development of small nucleic acid drugs targeting chronic hepatitis B and cardiovascular diseases, such as HengRui Medicine, China National Pharmaceutical Group, and others [9].

Core Viewpoint - Biogen Inc. announced a positive opinion from the CHMP recommending marketing authorization for ZURZUVAE (zuranolone) for treating postpartum depression (PPD) in adults, which could be the first EU-approved treatment specifically for PPD if approved by the European Commission [1][5]. Company Summary - Biogen is a leading biotechnology company founded in 1978, focusing on innovative science to develop new medicines and create shareholder value [8]. - The company collaborates with Sage Therapeutics for the development and commercialization of ZURZUVAE, holding exclusive rights outside the U.S. [7]. Product Summary - ZURZUVAE is a once-daily, oral, 14-day treatment for PPD, approved by the FDA in 2023, and is a neuroactive steroid that modulates GABA-A receptors [6]. - The treatment has shown potential for symptom improvement as early as day three of a 14-day course, with significant reductions in depressive symptoms observed [2][4]. Market Opportunity - An estimated 5-20% of women experience PPD symptoms in Europe, with many cases going undiagnosed due to varying clinical guidelines [3]. - The recommendation for ZURZUVAE is based on the SKYLARK Study, which demonstrated significant efficacy in reducing depression severity compared to placebo [4].

Core Insights - Biogen Inc. will present significant data at the 2025 Alzheimer's Association International Conference (AAIC) regarding LEQEMBI (lecanemab) and BIIB080, focusing on long-term results and new treatment formulations [1][2][6] Group 1: LEQEMBI (lecanemab) Developments - The upcoming presentations will include 48-month results from the Clarity AD open-label extension, real-world evidence, and insights into a subcutaneous formulation for maintenance dosing of LEQEMBI [1][2][6] - LEQEMBI is a humanized IgG1 monoclonal antibody targeting amyloid-beta, which received traditional FDA approval on July 6, 2023, for treating Alzheimer's disease [8][9] Group 2: BIIB080 Investigational Therapy - BIIB080 is an investigational antisense oligonucleotide (ASO) therapy targeting tau protein, currently in a Phase 2 clinical study for early Alzheimer's disease [5][6] - The CELIA trial will provide baseline characteristics of participants, contributing to the understanding of tau-targeted therapies [2][7] Group 3: Educational Initiatives - Biogen will host an interactive booth at AAIC to educate attendees on the role of tau in Alzheimer's disease and will launch a new e-learning module on KnowTau.com [4][6] - The educational program aims to bridge research and clinical practice regarding tau therapies and biomarkers [7]

Core Viewpoint - Biogen Inc. plans to invest an additional $2 billion in its manufacturing operations in North Carolina's Research Triangle Park, building on approximately $10 billion already invested, to support its late-stage clinical pipeline [1][2]. Investment Plans - The upcoming investment will enhance Biogen's capabilities in antisense oligonucleotide (ASO) production, establish multi-platform fill finish capabilities, and modernize manufacturing technologies through advanced automation and artificial intelligence [2][3]. - Biogen's manufacturing footprint in the U.S. has been crucial for its success, and this investment aims to modernize and expand its capabilities to ensure a resilient supply for patients [3]. Employment and Production - Biogen is the largest biotechnology employer in North Carolina, employing over 1,500 manufacturing and technical staff, along with more than 400 skilled contractors [4]. - More than 90% of Biogen's commercial medicines undergo manufacturing and quality control testing in the U.S. [4]. Industry Context - The U.S. government is promoting domestic pharmaceutical manufacturing, with President Trump's executive order aimed at streamlining the establishment of new production sites amid tariff uncertainties [5]. - Other pharmaceutical companies are also increasing their investments in U.S. manufacturing, with notable commitments from Eli Lilly, Thermo Fisher Scientific, and Novartis, among others [6][7][8][9].