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 ...

Core Insights - AbbVie has developed a strong neuroscience franchise, initially driven by blockbuster drugs like Botox Therapeutic and Vraylar, and has expanded its portfolio with new migraine treatments Qulipta and Ubrelvy, as well as Vyalev for Parkinson's disease [1][2]. Financial Performance - The neuroscience segment contributed over 17% to AbbVie's total sales in the first half of 2025, with revenues growing nearly 21% year over year, primarily due to increased sales of Botox Therapeutic and Vraylar, along with rising uptake of Ubrelvy and Qulipta [2][9]. - The strong performance in the neuroscience segment has helped mitigate the decline in Duodopa sales [2][9]. Product Launches and Acquisitions - AbbVie launched Vyalev in the U.S. earlier this year, and while initial sales have been modest, expectations are for its contribution to total revenues to grow over time [3]. - The company is actively investing in new therapies, including a recent agreement to acquire Gilgamesh Pharmaceuticals' lead pipeline drug for approximately $1.2 billion, which targets major depressive disorder (MDD). This follows a $1.4 billion acquisition of Aliada Therapeutics, which added an investigational antibody for Alzheimer's disease (AD) [4][5]. Competitive Landscape - Major competitors in the neuroscience space include Biogen and Johnson & Johnson. Biogen is diversifying its offerings due to declining revenues in its multiple sclerosis franchise and has partnered with Eisai to market an FDA-approved treatment for Alzheimer's disease [6]. - Johnson & Johnson has a strong neuroscience portfolio, including the antidepressant nasal spray Spravato and the antipsychotic Invega Sustenna, and recently acquired Intra-Cellular Therapies to enhance its offerings [7]. Valuation and Market Performance - AbbVie shares have outperformed the industry year to date, trading at a premium with a price/earnings (P/E) ratio of 15.59, compared to the industry average of 14.84 and above its five-year mean of 12.82 [8][11]. - Earnings per share (EPS) estimates for 2025 and 2026 have seen slight increases in the past 30 days [12].

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 Insights - AbbVie holds a leadership position in the neuroscience space, with significant products including Botox Therapeutic and Vraylar, contributing to over 17% of the company's first-quarter revenues, which grew 16% year over year [1][10]. Neuroscience Franchise Performance - The neuroscience franchise is estimated to generate $2.5 billion in sales for Q2 2025, reflecting a 15% year-over-year growth, driven by higher sales of Botox Therapeutic and Vraylar, along with market share gains for Ubrelvy and Qulipta [2][10]. - Newly launched Vyalev is expected to contribute modest sales in the U.S., with the majority of its revenue coming from international markets [3][10]. Competitive Landscape - Major competitors in the neuroscience space include Biogen and Johnson & Johnson [5]. - Biogen generates over half of its revenue from neuroscience therapies and markets FDA-approved treatments for Alzheimer's disease and postpartum depression [6]. - Johnson & Johnson's neuroscience portfolio includes leading products like Spravato and Invega Sustenna, with recent acquisitions enhancing its offerings [8]. Valuation and Market Performance - AbbVie shares have outperformed the industry year to date, trading at a price/earnings (P/E) ratio of 14.06, slightly below the industry average of 14.60 [9][12]. - EPS estimates for 2025 have decreased from $12.32 to $11.98, while estimates for 2026 have increased from $14.06 to $14.08 over the past month [13].

Core Viewpoint - The article discusses the investigation by Monteverde & Associates PC into the proposed sale of Sage Therapeutics, Inc. to Supernus Pharmaceuticals, Inc., focusing on the financial implications for current shareholders and the contingent value rights associated with the transaction [1]. Company Overview - Sage Therapeutics, Inc. is involved in a proposed sale to Supernus Pharmaceuticals, Inc. Current shareholders are set to receive $8.50 per share in cash, along with a non-tradable contingent value right worth up to $3.50 per share [1]. Financial Details - The contingent value right includes three potential cash payments: - $0.50 upon the first commercial sale of the drug Zurzuvae in Japan by June 30, 2026 - $1.00 when net sales of Zurzuvae reach or exceed $300 million in the U.S. by December 31, 2028 - $1.00 when net sales of Zurzuvae reach or exceed $375 million in the U.S. by December 31, 2030 [1]. Legal Context - Monteverde & Associates PC is recognized as a top firm in securities class action services and has a successful track record in recovering money for shareholders [1].

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]

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]