Key Takeaways Biogen's MS drugs and Spinraza face mounting competition, pressuring overall sales growth.New launches like Leqembi, Skyclarys, and Zurzuvae delivered strong sequential gains.Despite rising new-drug sales, BIIB's total 2025 revenue is projected to remain flat versus 2024 levels.Sales of Biogen’s (BIIB) key multiple sclerosis (“MS”) drugs like Tecfidera and Tysabri and spinal muscular atrophy (SMA) treatment, Spinraza, are being hurt due to competitive pressure, which is hurting top-line growth ...

Company Overview - Biogen Inc. has a market cap of $21.8 billion and specializes in therapies for neurological and neurodegenerative diseases, including multiple sclerosis and spinal muscular atrophy treatments [1] - The company is classified as a "large-cap" stock, valued at $10 billion or more, and is advancing treatments in Alzheimer's disease and other neurological disorders through strategic collaborations and innovation [2] Stock Performance - Biogen's shares have declined 28.3% from its 52-week high of $204.18, while the stock has risen nearly 11% over the past three months, underperforming the Nasdaq Composite's 12.6% increase [3] - Year-to-date, BIIB stock is down nearly 4%, lagging behind the Nasdaq's 14.7% gain, and has decreased 25.8% over the past 52 weeks compared to the Nasdaq's over 26% return [4] Financial Results - On July 31, Biogen reported Q2 2025 adjusted EPS of $5.47 and revenues of $2.65 billion, both exceeding expectations, driven by stronger sales of MS drugs like Vumerity and Tysabri [5] - Management raised its full-year adjusted EPS guidance to $15.50 - $16, indicating a more optimistic outlook for 2025 [5] Analyst Sentiment - Despite the stock's underperformance, analysts maintain a moderately optimistic view on Biogen, with a consensus rating of "Moderate Buy" from 34 analysts and a mean price target of $170.24, representing a 16.5% premium to current levels [6]

Core Insights - Biogen reported strong second-quarter 2025 results, with adjusted earnings per share (EPS) of $5.47, significantly exceeding the Zacks Consensus Estimate of $3.93, and a 4% year-over-year increase in earnings [1] - Total revenues for the quarter reached $2.65 billion, up 7% year over year, surpassing the Zacks Consensus Estimate of $2.32 billion [2] Revenue Breakdown - Product sales were $1.9 billion, a slight decline of 1% year over year, while revenues from anti-CD20 therapeutic programs increased by 5% to $467 million [3] - Contract manufacturing and royalty revenues surged 124% year over year to $245 million, and Alzheimer's collaboration revenues rose to $55 million from $12 million in the previous year [4][5] Performance of Key Products - Sales of Biogen's multiple sclerosis (MS) drugs totaled $1.1 billion, down 4% year over year, primarily due to generic competition for Tecfidera and biosimilar competition for Tysabri [7] - Tecfidera sales fell nearly 23% to $193.6 million, while Vumerity sales increased by around 30% to $212.2 million [8] - Spinraza sales declined 8.5% to $392.7 million, missing estimates, while rare disease drug Skyclarys generated $130.3 million, up 5.2% sequentially [12] New Product Performance - New drugs Leqembi, Skyclarys, and Zurzuvae showed strong demand and sequential sales growth, with Leqembi generating $63 million in U.S. sales, a 20% increase [5][11] - Zurzuvae recorded $46.4 million in sales, up 68% sequentially, driven by increased demand [13] Cost and Guidance Updates - Adjusted R&D expenses decreased by 13% to $394 million, while SG&A expenses rose 7% to $579 million [16] - Biogen raised its 2025 EPS outlook to $15.50-$16.00, reflecting a stronger business outlook, and expects total revenues to be flat compared to 2024 [18] Market Reaction and Future Outlook - The positive guidance and strong sales of Leqembi boosted investor confidence, leading to a more than 5% rise in pre-market trading [20] - Despite rising competitive pressure on MS drugs, new products have the potential to drive growth, although it remains uncertain if they can offset declines in existing products [21]

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].

Core Viewpoint - Biogen reported first-quarter 2025 adjusted earnings per share (EPS) of $3.02, missing the Zacks Consensus Estimate of $3.32, with an 18% year-over-year decline in earnings due to a $165 million upfront payment to Stoke Therapeutics for a collaboration agreement [1][2][19] Financial Performance - Total revenues for Q1 2025 were $2.43 billion, reflecting a 6% year-over-year increase on a reported basis and an 8% increase on a constant-currency basis, surpassing the Zacks Consensus Estimate of $2.23 billion [2] - Total product sales reached $1.73 billion, up 1% year over year on a reported basis and 3% on a constant-currency basis [4] - Contract manufacturing and royalty revenues surged 61% year over year to $293 million, while Alzheimer's collaboration revenues increased to $33 million from $3 million in the prior year [5][6] Product Sales Breakdown - Multiple sclerosis (MS) revenues totaled $953 million, down 11% on a reported basis due to generic competition for Tecfidera [9] - Sales of Spinraza rose 24.2% to $423.9 million, exceeding the Zacks Consensus Estimate of $365 million [12] - New drug Qalsody for ALS recorded sales of $15.5 million, while Zurzuvae for postpartum depression generated $28 million in sales, reflecting a 21.7% sequential increase [13][14] Cost and Guidance - Adjusted R&D expenses decreased 3% year over year to $427 million, while adjusted SG&A expenses rose 1% to $572 million [16] - The company reaffirmed its total revenue guidance for 2025, expecting a mid-single-digit percentage decline in constant currency terms compared to 2024, and lowered its adjusted EPS guidance to a range of $14.50 to $15.50 [18][19] Market Performance - Year to date, Biogen's shares have declined 20.9%, compared to a 3.3% decrease in the industry [3]

Industry Overview - The first-quarter earnings season for the drug and biotech sector is underway, with major companies like Pfizer, Eli Lilly, Amgen, Biogen, and Regeneron set to announce results [1] - Johnson & Johnson and Merck have reported results, both exceeding first-quarter estimates for earnings and sales, while Sanofi had mixed results, beating earnings estimates but missing sales [1] Earnings Trends - As of April 23, 15% of companies in the Medical sector, representing 33.8% of the sector's market capitalization, reported quarterly earnings, with 77.8% surpassing estimates for both earnings and revenues [3] - Year-over-year earnings increased by 4.7%, and revenues rose by 9.4% [3] - Overall, first-quarter earnings for the Medical sector are expected to increase by 35%, while sales are projected to rise by 7.8% compared to the previous year [3] Company Performance Pfizer (PFE) - Pfizer has consistently exceeded earnings expectations in the last four quarters, with an average earnings surprise of 44.16% [5] - The Zacks Consensus Estimate for first-quarter sales and earnings is $13.88 billion and 64 cents per share, respectively [6] - Non-COVID operational revenues are driving growth, supported by products like Vyndaqel, Padcev, and Eliquis, despite a decline in sales of COVID products [7] Eli Lilly (LLY) - Eli Lilly has had mixed performance, exceeding earnings expectations in three of the last four quarters, with an average earnings surprise of 8.47% [8] - The Zacks Consensus Estimate for sales and earnings is $12.62 billion and $3.52 per share, respectively [8] - Growth is expected to be driven by demand for FDA-approved tirzepatide medicines, although sales of Mounjaro and Zepbound were below expectations [9][10] Amgen (AMGN) - Amgen has shown strong performance, beating earnings estimates in each of the last four quarters, with an average earnings surprise of 5.23% [11] - The Zacks Consensus Estimate for first-quarter sales and earnings is $7.96 billion and $4.15 per share, respectively [11] - Product sales are expected to be driven by strong volume growth, although prices may decline due to higher rebates [12] Biogen (BIIB) - Biogen has consistently beaten earnings estimates in the last four quarters, with an average earnings surprise of 11.80% [13] - The Zacks Consensus Estimate for sales and earnings is $2.23 billion and $3.52 per share, respectively [13] - Lower sales of multiple sclerosis drugs are likely to be offset by revenues from new drugs [14] Regeneron (REGN) - Regeneron has had mixed results, surpassing earnings expectations in three of the last four quarters, with an average earnings surprise of 3.23% [16] - The Zacks Consensus Estimate for first-quarter sales and earnings is $3.28 billion and $8.43 per share, respectively [17] - Sales of Eylea are expected to have declined due to competition, but sales of Eylea HD and Dupixent are likely to have surged [18][19]

Core Viewpoint - Biogen is expected to report first-quarter 2025 results on May 1, with sales and earnings estimates at $2.24 billion and $3.34 per share, respectively. The company faces challenges from declining sales of multiple sclerosis (MS) drugs, which may be offset by revenues from new drugs [1][2][5]. Sales Performance of MS Drugs - Sales of Biogen's MS drugs, including Tecfidera and Tysabri, are anticipated to decline due to increased competition and the introduction of generic versions in various markets [2][5]. - The Zacks Consensus Estimate for Tecfidera sales is $199.0 million, while the internal estimate is $185.7 million. For Tysabri, the estimates are $363.0 million and $348.6 million, respectively [3][4]. - Vumerity's sales rose in the fourth quarter due to higher demand, with estimates for the first quarter at $141.0 million (Zacks) and $139.8 million (internal) [4]. Impact of Biosimilars and Generics - The decline in MS revenues is expected to be more pronounced in 2025 due to the anticipated entry of biosimilars for Tysabri and generics for Tecfidera in certain European markets [5]. Other Drug Sales - Spinraza's sales improved in the fourth quarter, but demand may have decreased in the first quarter, with estimates at $364.0 million (Zacks) and $338.1 million (internal) [6]. - Sales of Skyclarys for Friedreich's ataxia are expected to rise year-over-year, with estimates at $110.0 million (Zacks) and $111.4 million (internal) [7]. - Zurzuvae's launch has exceeded expectations, with strong patient demand likely contributing to improved sales in the first quarter [8][9]. Alzheimer's Collaboration and Revenues - Revenues from contract manufacturing, royalties, and Alzheimer's collaboration are expected to rise, particularly from the drug Leqembi, which has shown strong sales growth in recent quarters [10][11]. - Leqembi's sales have improved sequentially, with strong growth noted in China and Japan, and it was recently approved in the European Union [11][12]. Overall Revenue Expectations - Overall revenues for the first quarter of 2025 are expected to be negatively impacted by seasonality, higher discounts, and channel dynamics in the U.S., along with foreign exchange headwinds [13]. Key Events - Biogen announced a collaboration with Stoke Therapeutics to develop zorevunersen for Dravet syndrome, with a pivotal study expected to begin in the first quarter of 2025 [14]. Earnings Surprise History - Biogen has consistently beaten earnings estimates in the past four quarters, with an average earnings surprise of 11.8%. However, the current model does not predict a beat for the upcoming quarter, with an Earnings ESP of -15.8% [15][16][17].

Core Insights - Biogen's key multiple sclerosis drugs, including Tecfidera and Tysabri, along with Spinraza for spinal muscular atrophy, are facing declining sales due to increased competition, leading to a 2% decline in total revenues in 2024, with a projected mid-single-digit percentage decline in 2025 [1][4][6] Group 1: Revenue Declines - Biogen's global MS revenues declined by 7% in 2024, with expectations of a steeper decline in 2025 due to the potential entry of Tysabri biosimilars in the U.S. and generic versions of Tecfidera in Europe [4] - Spinraza sales fell nearly 10% in 2024, attributed to competitive pressure and decreased demand, with little improvement anticipated in 2025 [4][10] Group 2: Competitive Landscape - The launch of multiple generic versions of Tecfidera in North America, Brazil, and Europe has negatively impacted its revenues [3] - Regulatory approvals for biosimilars of Tysabri in the U.S. and Europe are contributing to the competitive pressure faced by Biogen [3][5] Group 3: New Drug Potential - Biogen is optimistic about new drugs like Leqembi for Alzheimer's, Skyclarys for Friedreich's ataxia, and Zurzuvae for depression, which are seen as potential drivers for long-term growth [2][8] - Leqembi has shown sequential improvement in sales since its launch, with expectations for continued growth in 2025 [7][8] Group 4: Market Challenges - The FDA approval of Eli Lilly's Alzheimer's drug Kisunla poses significant competition to Leqembi [5] - Foreign exchange headwinds are expected to negatively impact 2025 revenues by 1%, alongside a projected $50 million to $100 million impact from the redesign of Medicare Part D [6] Group 5: Pipeline Developments - Biogen faced setbacks in its pipeline, including the discontinuation of Zurzuvae's development for major depressive disorder, which had a larger market potential than its current indication [5] - The acquisition of Reata Pharmaceuticals added Skyclarys to Biogen's portfolio, which is experiencing strong launch trends [9]