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01/10 16:15
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call highlights strong financial performance, including a 19% YoY revenue increase and a 10% rise in EPS. The successful launch of ALYFTREK and strong uptake, along with strategic investments in pipeline advancements, indicate a positive outlook. Despite some uncertainties in guidance, the overall sentiment is bolstered by share repurchases and promising drug developments, suggesting a positive stock price movement.
Revenue $3.08 billion in Q3 2025, reflecting double-digit growth versus Q3 2024. U.S. revenue grew 15% year-over-year driven by CF patient demand, favorable net pricing, and contributions from ALYFTREK, CASGEVY, and JOURNAVX. Revenue outside the U.S. grew 4% year-on-year.
CASGEVY Revenue $17 million in Q3 2025. Momentum continues to build with nearly 300 patients referred for treatment since launch, 160 patients having their first cell collection, and 39 patients receiving infusions.
JOURNAVX Revenue $20 million in Q3 2025. Over 300,000 prescriptions filled as of mid-October 2025. Positive reception in the market with significant reductions in opioid use.
Non-GAAP Operating Expenses $1.28 billion in Q3 2025, up 19% year-on-year due to pipeline advancements and commercial build-out for pain.
Non-GAAP Operating Income $1.38 billion in Q3 2025, compared to $1.31 billion in Q3 2024.
Non-GAAP Net Income $1.24 billion in Q3 2025, compared to $1.14 billion in Q3 2024.
Non-GAAP Earnings Per Share $4.80 in Q3 2025, an increase of 10% compared to $4.38 in Q3 2024.
Cash and Investments $12 billion at the end of Q3 2025 after deploying $1.1 billion for share repurchases.
ALYFTREK: Launched in the U.S. late last year and is launching in Europe now. It treats more mutations than TRIKAFTA and has seen a strong response from patients and physicians. It is a once-daily medicine that can bring sweat chloride levels down in patients ages 6 plus to the lowest levels achieved of any CFTR modulator in this age group.
TRIKAFTA: Completed pivotal study for 1- to 2-year-old patient population with remarkable results. Global regulatory submissions for this population are on track for the first half of 2026.
JOURNAVX: A novel non-opioid option for moderate to severe acute pain. Over 300,000 prescriptions filled as of mid-October. Broad adoption by physicians and positive feedback from patients. Significant reductions in opioid use observed.
CASGEVY: A transformative one-time treatment for severe sickle cell disease and beta thalassemia. Clear line of sight to over $100 million in revenue this year. Nearly 300 patients referred for treatment, with 39 patients having received infusions.
Geographic Expansion: ALYFTREK launched in Europe, including England, Ireland, Germany, and Denmark. CASGEVY secured reimbursement in Italy, which has the second-largest population of TDT patients globally.
New Patient Access: ALYFTREK expanded access to nearly 10x as many newly eligible patients in Europe compared to the U.S. JOURNAVX achieved broad payer coverage, including 170 million lives across commercial and government payers.
Pipeline Advancements: Progress in CF, pain, and kidney disease portfolios. Initiated pivotal studies for multiple kidney diseases and resumed enrollment in VX-522 for CF patients who cannot benefit from CFTR modulators.
Manufacturing and Commercialization: Build-out of commercialization team for renal medicine. Expanded field representatives for JOURNAVX to increase physician engagement.
Renal Medicine Focus: Vertex is building a renal franchise with povetacicept (Pove) as a potential best-in-class treatment for IgAN and other kidney diseases. Pove received breakthrough therapy designation and rolling review for BLA submission.
Revenue Diversification: Vertex is diversifying its revenue base by product and geography, with significant contributions from ALYFTREK, CASGEVY, and JOURNAVX.
Regulatory Risks: The company faces regulatory risks, including the need for global regulatory submissions for TRIKAFTA in the 1-2 year-old population by 2026 and potential delays in approvals for other pipeline products like povetacicept (Pove) in IgAN and other kidney diseases. Additionally, the temporary postponement of dosing in the pivotal trial for Zimislecel in type 1 diabetes due to internal manufacturing analysis could impact timelines.
Pipeline Development Challenges: The company is heavily reliant on its pipeline development, including multiple Phase III trials for products like VX-407, inaxaplin, and Pove. Any delays or failures in these trials could significantly impact future growth and revenue projections.
Market Competition: Vertex faces competitive pressures in the CF market, particularly as it transitions patients from TRIKAFTA to ALYFTREK. The company also faces competition in the acute pain market with JOURNAVX and in the kidney disease market with Pove.
Supply Chain and Manufacturing Risks: The temporary postponement of dosing in the Zimislecel trial due to manufacturing issues highlights potential vulnerabilities in the supply chain and production processes.
Economic and Pricing Pressures: The company’s revenue growth is partly dependent on favorable net pricing, particularly in the U.S. Any changes in pricing regulations or economic conditions could adversely affect revenue.
Geographic Expansion Risks: The company is expanding into new geographies like Brazil and Turkey for its CF products. Challenges in these markets, such as regulatory hurdles or slower-than-expected uptake, could impact growth.
Reimbursement and Payer Coverage Risks: The success of products like JOURNAVX depends on securing broad payer coverage. Delays or challenges in obtaining reimbursement could limit market penetration.
Revenue Guidance: Vertex expects 2025 total revenue to be in the range of $11.9 billion to $12 billion, representing growth of approximately 8% to 9% for the full year at current exchange rates. This includes over $100 million of CASGEVY revenue and further contributions from JOURNAVX in the fourth quarter.
CF Franchise Outlook: Vertex anticipates continued growth in the CF franchise, driven by the ongoing launch of ALYFTREK in the U.S. and recent launches in Europe. The company expects the majority of patients globally to transition to ALYFTREK over time due to its clinical benefits and convenience.
CASGEVY Outlook: Vertex projects significant growth for CASGEVY in 2026, with a clear line of sight to over $100 million in revenue for 2025. The company has seen progress in securing access globally, including reimbursement in Italy, and expects continued growth in patient onboarding and treatment initiation.
JOURNAVX Outlook: Vertex plans to expand coverage for JOURNAVX across commercial, Medicare, and Medicaid payers through 2025 and into 2026. The company is adding 150 additional representatives in Q1 2026 to increase physician engagement and expand coverage. JOURNAVX is expected to become a multibillion-dollar franchise.
Povetacicept (Pove) in IgAN: Vertex plans to submit for potential accelerated approval of Pove in IgAN before the end of 2025, with a full BLA submission expected in the first half of 2026. The company anticipates a priority review and expedited approval process in the U.S., with commercialization preparations underway.
Renal Medicine Portfolio: Vertex is building out its renal franchise, with pivotal studies underway for multiple indications, including IgAN and primary membranous nephropathy. The company expects its renal franchise to become a significant growth driver over the next several years.
Pipeline Progress: Vertex is advancing its pipeline with five programs in Phase III development and additional earlier-stage R&D initiatives. The company is focused on achieving R&D milestones and preparing for near-term potential launches.
Share Repurchase Program: Vertex repurchased more than 2.7 million shares in the third quarter of 2025, deploying approximately $1.1 billion. Year-to-date, the company has spent over $1.9 billion to repurchase approximately 4.5 million shares. The company emphasized that its priorities for cash deployment remain unchanged, focusing on innovation and growth through internal and external investments, with share repurchases as a secondary priority.
The earnings call highlights strong financial performance, including a 19% YoY revenue increase and a 10% rise in EPS. The successful launch of ALYFTREK and strong uptake, along with strategic investments in pipeline advancements, indicate a positive outlook. Despite some uncertainties in guidance, the overall sentiment is bolstered by share repurchases and promising drug developments, suggesting a positive stock price movement.
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