Skyclarys

Search documents
Can Biogen Stock Rebound as New Drugs Aim to Offset MS Sales Declines?
ZACKS· 2025-10-10 16:56
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 ...
Biogen Gets EU Nod for First Postpartum Depression Drug
ZACKS· 2025-09-18 14:21
Core Insights - Biogen's Zurzuvae (zuranolone) has received approval from the European Commission for the treatment of postpartum depression (PPD) in adults, making it the first and only approved treatment for this indication in the European Union [1][7] - The approval is based on the successful phase III SKYLARK study, which demonstrated rapid and sustained relief from depressive symptoms [2][7] - Biogen's stock has underperformed this year, with a 5% decline compared to a 3% growth in the industry [3] Product Performance - Zurzuvae was launched in the United States in December 2023, and sales reached $46.4 million in Q2 2025, reflecting a 68% increase sequentially due to rising demand [6][7] - The drug's launch exceeded Biogen's internal expectations, indicating strong market acceptance [6][7] Strategic Partnerships - Zurzuvae was developed in collaboration with Sage Therapeutics, which has been acquired by Supernus Pharmaceuticals. Biogen and Supernus share profits and losses from the commercialization of Zurzuvae in the U.S. [5] Future Growth Potential - Zurzuvae is one of four new product launches by Biogen, alongside Leqembi for Alzheimer's disease, Skyclarys for Friedreich's Ataxia, and Qalsody for ALS, which are expected to drive long-term growth [8]
渤健上调2025年财务指引,阿尔茨海默病药物销量持续增长
Huan Qiu Wang· 2025-08-01 07:10
Core Insights - Biogen has raised its financial guidance for 2025, driven by the continued growth in sales of its Alzheimer's drug, Leqembi, which has helped the company exceed Wall Street revenue expectations [1][3] Financial Performance - Biogen expects earnings per share for 2025 to reach $15.50 to $16.00, an increase from the previous forecast of $14.50 to $15.50 [3] - The company anticipates that total revenue for this year will remain flat compared to 2024, revising earlier expectations of a low single-digit percentage decline [3] - In Q2, Biogen reported total revenue of $2.6 billion, surpassing analyst expectations of $2.3 billion [3] Product Performance - Leqembi generated global revenue of $125 million in Q2, exceeding Wall Street expectations [3] - Sales of Leqembi in the previous two quarters were $96 million and $87 million, respectively [3] - The rare disease treatment Skyclarys achieved approximately $130 million in sales, aligning with expectations [3] Strategic Direction - Since taking office at the end of 2022, CEO Chris Viehbacher has focused on transforming Biogen by enhancing Leqembi sales, cutting costs, and reducing reliance on high-risk neurological drugs [3]
Biogen's Q2 Earnings & Sales Beat, 2025 Outlook Raised, Stock Up
ZACKS· 2025-07-31 15:50
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]
百健(BIIB.US)Q2业绩超预期 阿尔茨海默药热销促盈利指引上调
智通财经网· 2025-07-31 12:47
Core Viewpoint - Biogen's latest quarterly earnings report exceeded Wall Street expectations, driven by strong sales of Alzheimer's drug Leqembi, prompting the company to raise its financial guidance [1][2] Financial Performance - Biogen reported total sales of $2.6 billion for the second quarter, a 7% year-over-year increase, surpassing analyst expectations of $2.3 billion [1] - The company's net profit for the quarter was $635 million, up from $584 million in the same period last year, with adjusted earnings per share reaching $5.47, a 4% increase and well above the average analyst estimate of $3.86 [1] - Revenue from the Alzheimer's drug Leqembi was $125 million in the latest quarter, significantly exceeding Wall Street's expectations [1] Product Performance - The Alzheimer's treatment Leqembi, developed in collaboration with Eisai, faced initial logistical challenges and regulatory hurdles but has shown strong sales growth, with previous quarters reporting $87 million and $96 million in sales [1] - The rare disease treatment Skyclarys contributed approximately $130 million in revenue, meeting market expectations [2] Future Outlook - Biogen raised its earnings per share forecast for 2025 from the previous range of $14.50-$15.50 to $15.50-$16.00 and adjusted its full-year revenue forecast to be flat compared to 2024 [2] - The company aims to alleviate investor concerns regarding the decline of its traditional multiple sclerosis business by focusing on new drug sales, including Leqembi [2] Strategic Initiatives - Since taking over as CEO in late 2022, Chris Viehbacher has focused on transforming Biogen by enhancing Leqembi sales, implementing cost reductions, and decreasing reliance on high-risk neurological treatments [2] - Biogen is open to acquiring new immunotherapy and rare disease treatment assets as part of its strategy to strengthen its research and development pipeline [2] Production and Tariff Policy - Biogen stated that the potential cancellation of drug tariff exemptions in the U.S. would not significantly impact its annual performance due to the majority of its U.S. revenue coming from domestic production [3] - To mitigate potential tariff risks, the company announced a $2 billion investment to expand its core manufacturing facility in North Carolina [3]
Biogen Gears Up to Report Q2 Earnings: Here's What to Expect
ZACKS· 2025-07-28 15:26
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].
BIIB's Q1 Earnings Miss, Revenues Top Mark, 2025 EPS Guidance Cut
ZACKS· 2025-05-01 17:45
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]
Can Biogen Keep the Beat Streak Alive This Earnings Season?
ZACKS· 2025-04-24 11:55
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].
Can BIIB's New Drugs Revive Growth as Multiple Sclerosis Sales Fall?
ZACKS· 2025-03-14 14:40
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]