Vertex Pharmaceuticals (VRTX) Q1 2025 Earnings Call May 05, 2025 04:30 PM ET Speaker0 Good day, and welcome to the Vertex Pharmaceuticals First Quarter twenty twenty five Earnings Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Ms. Susie Lisa. Please go ahead, ma'am. Speaker1 Good evening, all. My name is Susie Lisa, and as the Senior Vice ...

Reiterates Full Year 2025 Financial GuidanceRADNOR, Pa., May 05, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today reported its financial results for the first quarter of fiscal year 2025. First Quarter Highlights: Revenue was $106.0 million, compared to $96.7 million in the first quarter of 2024, representing growth of 10%. Software revenue was $46.4 million, compared to $39.3 million in the first quarter of 2024, representing growth of 18%.Ser ...

Financial Data and Key Metrics Changes - Total product revenues for Q1 2025 were $121.5 million, representing a year-over-year growth of 62% compared to $75 million in Q1 2024 [16][17] - Net loss for Q1 2025 was $59.4 million or $1.22 per share, an improvement from a net loss of $68.4 million or $1.44 per share in Q1 2024 [20] - Cash and cash equivalents at the end of Q1 2025 were $300.9 million, down from $315.4 million at year-end [20] Business Line Data and Key Metrics Changes - Avelity net product sales were $96.2 million for Q1 2025, representing 80% year-over-year growth from $53.4 million in Q1 2024 [17] - Sunosi net product revenues were $25.2 million for Q1 2025, a 17% year-over-year increase from $21.6 million in Q1 2024 [17][18] - Avelity led the market in TRx growth in Q1 with approximately 167,000 prescriptions, reflecting 76% year-over-year growth [21] Market Data and Key Metrics Changes - Avelity coverage remained stable in Q1 with 78% of all lives covered across channels and 63% in the commercial segment [22] - Sunosi total prescriptions were over 46,000, representing a 12% growth versus Q1 2024 [23] - Payer coverage for Sunosi was stable with 83% of lives covered across channels [25] Company Strategy and Development Direction - The company aims to advance three novel NDA stage product candidates: AXS-fourteen for fibromyalgia, AXS-five for Alzheimer's disease agitation, and AXS-twelve for narcolepsy [6][10] - The company is focused on executing multiple Phase III clinical programs to broaden the potential of current products and candidates [6] - The company anticipates a strong launch for Cymbravo, with positive feedback from healthcare providers regarding its clinical profile [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate trade policy developments, stating that any potential impact would be immaterial [13] - The company expects 2025 to be a catalyst-rich year with potentially five marketed products across six indications by 2026 [15] - Management remains optimistic about achieving cash flow positivity based on the current operating plan [20][96] Other Important Information - The company has submitted an NDA for AXS-fourteen and anticipates a decision in Q2 2025 [7] - AXS-five has been granted breakthrough therapy designation by the FDA, with an sNDA submission planned for Q3 2025 [9] - The company is closely monitoring the competitive landscape, particularly regarding new entrants in the narcolepsy treatment space [35] Q&A Session Summary Question: Recent interactions with the FDA regarding developmental agents - Management indicated that dialogue with the FDA remains status quo and no changes have been noted regarding review teams or agency responsiveness [30] Question: DTC advertising plans for Avelity - A national campaign is expected to launch later this year, with a focus on engaging patients [34] Question: Coverage expectations for Avelity - Management aims to increase the number of covered lives and reduce utilization management barriers [68] Question: Expected cadence of coverage for Cymbravo - Management is focused on securing access quickly, acknowledging the competitive market [48] Question: Sales potential for AXS-fourteen in fibromyalgia - Management is enthusiastic about the market opportunity, with approximately 17 million people diagnosed in the U.S. [63] Question: Profitability outlook for 2025 - Management remains confident in achieving cash flow positivity but has not provided specific guidance on timing for profitability [96]

Press Release – No. 7 / 2025 Zealand Pharma conference call on May 8 at 2pm CET (8am ET) to present first quarter 2025 financial results Copenhagen, Denmark, May 1, 2025 – Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced that it will host a conference call on May 8, 2025, at 2:00 pm CET (8:00 am ET) following the announcement of financial results for the first quarter / first thr ...

Core Insights - Idorsia Ltd reported significant financial improvements in Q1 2025, with net revenue reaching CHF 59 million, a substantial increase from CHF 10 million in Q1 2024, driven by strong sales of QUVIVIQ and a one-off exclusivity fee [4][6][11] - The company has streamlined its R&D organization and focused on its promising pipeline, which includes QUVIVIQ and TRYVIO, positioning itself for growth in 2025 [3][20] Financial Highlights - Q1 2025 net revenue was CHF 59 million, compared to CHF 10 million in Q1 2024, with QUVIVIQ product sales contributing CHF 25 million [4][6] - Operating income for Q1 2025 was CHF 67 million, up from CHF 31 million in Q1 2024, while net income increased to CHF 63 million from CHF 30 million [4][6][8] - Non-GAAP operating loss for Q1 2025 was CHF 17 million, a significant improvement from a loss of CHF 85 million in Q1 2024 [10][11] Product Performance - QUVIVIQ demonstrated strong performance with net sales of CHF 25 million in Q1 2025, and demand in Europe and Canada grew by 50% from Q4 2024 to Q1 2025 [5][31] - In France, QUVIVIQ's market share increased significantly, with a new-to-brand share growing from 1.1% in September 2024 to 9.3% in January 2025 [25] - TRYVIO received FDA approval and had its REMS requirement removed, allowing for broader distribution in retail pharmacies [3][38] Strategic Developments - Idorsia restructured its convertible bond debt and secured a CHF 150 million new money facility to alleviate short- to mid-term debt overhang [16][20] - The updated agreement with Viatris reduced Idorsia's development cost contributions and expanded territorial rights, enhancing financial flexibility [14][20] - The company aims for continued growth in 2025, projecting QUVIVIQ net sales of around CHF 110 million and a non-GAAP operating loss of approximately CHF 215 million [18][19] Research and Development - Idorsia is focusing its drug discovery efforts on fewer active projects, preparing some for out-licensing while developing others to the next inflection point [41][42] - Recent publications highlighted the efficacy of daridorexant in treating chronic insomnia and nocturia, supporting its market potential [44][45] Liquidity and Indebtedness - As of March 31, 2025, Idorsia's liquidity stood at CHF 51 million, down from CHF 106 million at the end of 2024 [21][22] - Total indebtedness remained stable at CHF 1.322 billion, with convertible loans and bonds unchanged [22][23]

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

Financial Data and Key Metrics Changes - Regeneron's Q1 2025 total revenues were $3 billion, driven by higher collaboration revenue from Sanofi and increased U.S. net sales of EYLEA HD compared to the prior year [41] - The diluted net income per share for Q1 2025 was $8.22, with net income of $928 million [42] - Gross margin on net product sales was 85%, reflecting a decrease due to higher inventory write-offs and a change in product mix [45] - Free cash flow generated in Q1 2025 was $816 million, with cash and marketable securities totaling $17.6 billion and debt of approximately $2.7 billion [46] Business Line Data and Key Metrics Changes - EYLEA U.S. net sales were $736 million, down 39% year-over-year and down 38% sequentially, primarily due to lower physician demand and increased competition [7][29] - EYLEA HD U.S. sales were $307 million, up 54% year-over-year and flat sequentially, with physician unit demand growing by 5% [8][30] - DUPIXENT achieved global net sales of $3.7 billion, representing a 20% year-over-year increase on a constant currency basis, with U.S. net sales growing 19% to $2.6 billion [32][33] - Libtayo's global net sales grew 8% year-over-year to $285 million, with U.S. net sales reaching $193 million, up 21% [38] Market Data and Key Metrics Changes - The branded anti-VEGF category contracted due to increased usage of low-cost off-label repackaged Avastin, which gained approximately 6 percentage points in market share to 32% [28] - EYLEA and EYLEA HD captured 41% of the anti-VEGF category, maintaining market leadership despite competitive pressures [28] Company Strategy and Development Direction - Regeneron aims to capitalize on multiple near-term opportunities across its portfolio, including product enhancements and launches of new medicines and indications [27] - The company is focused on promoting the ongoing adoption of EYLEA HD, which has the potential to become the new standard of care [29] - Significant investments in R&D are planned, with approximately 45 product candidates in clinical development and expectations for multiple regulatory approvals in 2025 [12][41] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a mixed performance in Q1 2025, with challenges in the retinal franchise but positive developments in other commercial areas and pipeline advancements [6] - The company remains committed to investing heavily in R&D and delivering scientific breakthroughs while maximizing growth opportunities from in-line brands [13] - Management expressed confidence in the potential for EYLEA HD and DUPIXENT to continue delivering significant growth [12][34] Other Important Information - Regeneron plans to return capital to shareholders through share repurchases and dividends, having repurchased approximately $1.1 billion worth of shares in Q1 2025 [48] - The company has updated its 2025 gross margin guidance to be in the range of 86% to 87% due to higher than expected inventory write-offs [49] Q&A Session Summary Question: Can you elaborate on the EYLEA HD CRL for the prefilled syringe? - Management explained that the FDA's questions pertained to a third-party component supplier, and they believe the key issue is being addressed. They expect a resolution could be quick but acknowledged uncertainty [52][56] Question: How does the company prioritize indications for Factor XI antibodies? - Management indicated that they are focusing on indications that demonstrate both anticoagulation benefits and lower bleeding risks, with plans to enroll patients in pivotal studies this year [61][63] Question: What are the updated thoughts on foundation funding for EYLEA? - Management discussed the complexities of patient assistance funding and the potential for a matching program to stimulate contributions from others, emphasizing the need for broader support [66][71] Question: Can you confirm if the component in the prefilled syringe is used in other approved products? - Management confirmed that the component is the same as that used in the prefilled syringe approved in Europe, which provides confidence in resolving the FDA's concerns [75][77] Question: What steps are being taken to improve regulatory performance? - Management acknowledged the challenges faced with CRLs and attributed them to increased scrutiny by the FDA on contract manufacturers, while expressing confidence in their regulatory team's capabilities [88][90]

SAN DIEGO, April 29, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Company will give two poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held May 4–8, 2025, in Salt Lake City, Utah. The presentations will highlight baseline patient ...

Reflects business philosophy of commercial success through patient accessibilityRecently executed agreement with CD 8 Technology Services LLC providing up to $50 million for Company’s dedicated R&D and manufacturing facility; no impact on shareholder equity WARREN, N.J., April 28, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), reaffirms its top-line revenue forecast for its oncology pipeline, projecting $1 billion in revenue in its launch year and a cumulative 5- ...

Core Insights - Cocrystal Pharma's investigational drug candidate CDI-988 demonstrates strong binding and potency against the GII.17 protease, similar to its effectiveness against GII.4 norovirus variants, which have been the dominant strains until recently [1][2] - The company plans to initiate a human norovirus challenge study in 2025 to evaluate CDI-988 for the prevention and treatment of norovirus infections [1][6] Company Overview - Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on developing novel antiviral therapeutics targeting noroviruses, influenza viruses, coronaviruses, and hepatitis C viruses [5] - The company utilizes unique structure-based technologies and expertise in structural biology to create first- and best-in-class antiviral drugs [5] Product Development - CDI-988 is a pan-viral protease inhibitor designed for broad-spectrum antiviral activity against noroviruses and coronaviruses, with a novel mechanism of action [3][4] - A Phase 1 study has been completed, showing favorable safety and tolerability for CDI-988 in healthy adults [3][6] Market Context - Norovirus is the leading cause of acute gastroenteritis globally, with an estimated 685 million cases and around 50,000 child deaths annually, resulting in a societal cost of approximately $60 billion [2] - The emergence of GII.17 variants has led to increased norovirus outbreaks in the U.S. and Europe [6]