Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39413 VERTEX, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 23-2081753 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) ...

Core Insights - Allka Research has over two decades of experience in investment, focusing on uncovering undervalued assets in ETFs, commodities, technology, and pharmaceutical sectors [1] - The company adopts a conservative investment approach, aiming to deliver substantial returns and strategic insights to clients [1] - Allka Research is committed to simplifying investment strategies, making them accessible for both seasoned and novice investors [1] Company Mission - The mission of Allka Research is to empower individuals financially by sharing knowledge and insights through the Seeking Alpha platform [1] - The company aims to provide thought-provoking analyses and informed perspectives to foster a community of informed investors [1] - Allka Research seeks to demystify investing, inspiring confidence in readers to navigate the financial markets intelligently [1]

Core Viewpoint - Vertex Pharmaceuticals has demonstrated its ability to develop successful drugs and generate earnings growth, positioning itself as a strong investment opportunity regardless of market conditions [1][2]. Company Overview - Vertex is the global leader in cystic fibrosis (CF) treatment and has expanded into gene editing for blood disorders and pain management, which supports sustained earnings growth [2][5]. - The company produces CFTR modulators that address approximately 90% of genetic mutations associated with CF, significantly improving the quality of life for patients [5][6]. Financial Performance - Vertex expects its non-CF products, including the gene editing treatment Casgevy and pain drug Journavx, to contribute over $500 million to revenue this year [7]. - The total revenue guidance for Vertex for the year is projected to reach as high as $13.1 billion [7]. Investment Strategy - Vertex is characterized as a "compounder," indicating its potential for long-term value appreciation, making it a suitable addition to a diversified investment portfolio [4]. - The company's strong intellectual property portfolio is expected to support its leadership in CF treatment for the coming decade, providing stability and growth for investors [6].

Legal and Regulatory Risks - The company is involved in various legal proceedings, including arbitration related to ALYFTREK royalty rights, which may lead to significant expenses and higher future costs of goods if royalty fees exceed expectations [216]. - The company faces evolving data privacy and security regulations globally, including GDPR and California Consumer Privacy Act, which may increase operational costs and compliance burdens [217]. - The effective tax rate may be impacted by changes in tax laws and ongoing audits, which could lead to additional tax liabilities [245][246]. - Social media presents risks, including potential regulatory scrutiny and reputational damage due to misinformation or inappropriate disclosures by employees [255]. Supply Chain and Operational Challenges - Supply chain disruptions could significantly impact the company's ability to meet market demand, potentially leading to inventory shortages and increased costs [220]. - The company is investing in expanding its manufacturing capabilities to support anticipated product demand, which requires substantial financial commitment [222]. - The company aims to expand its global supply chains and manufacturing capabilities for biologic and cell and gene therapies [259]. Competition and Market Position - The company may face significant competition for strategic transactions from other firms with greater financial resources, which could hinder timely completion of future deals [241]. - The company faces intense competition for skilled employees, which could impact its ability to advance its pipeline and achieve business objectives [254]. - The company emphasizes the need to attract and retain skilled employees, particularly in the fields of biologic and cell therapies, to advance its product pipeline and commercialization efforts [254]. Financial Position and Strategic Transactions - Future strategic transactions could result in dilutive equity issuances or increased debt, impacting the company's financial position [242]. - The company has a share repurchase program authorized for up to $4.0 billion, with $618.5 million repurchased as of December 31, 2025 [249]. - Future indebtedness could adversely affect the company's financial condition, with restrictions imposed by credit agreements [248]. - The company faces risks related to foreign currency rates, interest rate fluctuations, and inflation, which may impact cash flows and financial results [247]. - The company is subject to risks associated with integrating acquired assets and may incur additional expenses or unanticipated liabilities [244]. Research and Development Initiatives - The company plans to continue investing in research and development programs, including the anticipated launch of new therapies [259]. - The company anticipates launching new products, including CASGEVY for SCD and TDT, ALYFTREK for CF, and JOURNAVX for acute pain, with expected regulatory submissions for povetacicept in IgAN by mid-2026 [259]. - The company plans to invest in research and development, focusing on expanding its pipeline and enhancing global supply chains for biologic and cell therapies [259]. Intellectual Property and Future Expectations - The company aims to maintain and expand its intellectual property portfolio to protect exclusive rights to its products [260]. - Expectations include a lower royalty burden for ALYFTREK and potential benefits from acquisitions, such as the acquisition of Alpine and its lead asset, povetacicept [259]. - Forward-looking statements are subject to risks and uncertainties that could lead to actual results differing materially from expectations, as outlined in the company's risk factors [261]. Stock Performance and Financial Guidance - The stock price fluctuated between $362.50 and $519.68 per share from January 1, 2025, to December 31, 2025 [253]. - The company's stock price fluctuated between $362.50 and $519.68 per share during 2025, indicating significant volatility that could adversely affect shareholder value [253]. - Financial guidance and results are subject to fluctuations based on revenue timing and expenses, impacting overall financial performance [258].

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Core Insights - Vertex Pharmaceuticals reported a revenue of $3.19 billion for the quarter ended December 2025, reflecting a year-over-year increase of 9.6% and surpassing the Zacks Consensus Estimate of $3.17 billion by 0.7% [1] - The earnings per share (EPS) for the quarter was $5.03, an increase from $3.98 in the same quarter last year, although it fell short of the consensus estimate of $5.07 by 0.74% [1] Revenue Breakdown - Total product revenues were $3.19 billion, exceeding the average estimate of $3.16 billion from eight analysts [4] - Revenue from ALYFTREK was reported at $380.1 million, surpassing the average estimate of $367.1 million from six analysts [4] - Revenue from Trikafta/Kaftrio was $2.57 billion, matching the average estimate from six analysts, but showing a year-over-year decline of 5.5% [4] - Other product revenues reached $237.4 million, exceeding the estimated $216.84 million and representing a year-over-year increase of 24.2% [4] Stock Performance - Over the past month, Vertex shares have returned +2.6%, while the Zacks S&P 500 composite experienced a -0.3% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]

分组1 - Vertex Pharmaceuticals reported quarterly earnings of $5.03 per share, missing the Zacks Consensus Estimate of $5.07 per share, but showing an increase from $3.98 per share a year ago, resulting in an earnings surprise of -0.74% [1] - The company posted revenues of $3.19 billion for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 0.70%, and showing an increase from year-ago revenues of $2.91 billion [2] - Vertex has surpassed consensus EPS estimates two times over the last four quarters and topped consensus revenue estimates three times during the same period [2] 分组2 - The stock's immediate price movement will depend on management's commentary during the earnings call, with Vertex shares having added about 1.7% since the beginning of the year compared to the S&P 500's gain of 1.4% [3] - The current consensus EPS estimate for the coming quarter is $4.65 on revenues of $3.11 billion, and for the current fiscal year, it is $19.92 on revenues of $12.91 billion [7] - The Medical - Biomedical and Genetics industry, to which Vertex belongs, is currently in the top 36% of over 250 Zacks industries, indicating a favorable outlook for the sector [8]

Financial Data and Key Metrics Changes - In Q4 2025, total revenue reached $3.2 billion, a 10% increase compared to Q4 2024. For the full year 2025, total revenue was $12 billion, reflecting a 9% increase versus 2024 [32][33] - Non-GAAP net income for Q4 2025 was $1.3 billion, up 24% year-over-year, resulting in earnings per share of $5.03, a 26% increase compared to the prior year [37] - The company ended 2025 with $12.3 billion in cash, cash equivalents, and marketable securities, positioning it well for future investments [37] Business Line Data and Key Metrics Changes - Cystic fibrosis (CF) therapies generated a full year 2025 growth of 7% globally, with U.S. CF revenue growing 11% year-over-year [32][33] - CASGEVY achieved $54 million in revenue in Q4 and $116 million for the full year 2025, demonstrating continued momentum in patient initiations [34][35] - JOURNAVX delivered $27 million in sales in Q4 and $60 million for the full year, with substantial growth in quarterly prescriptions since its launch [34] Market Data and Key Metrics Changes - The CF population has seen a 3% annual increase over the last five years, contributing to revenue growth [22] - In Europe, reimbursement for ALYFTREK has been secured in key countries, including the UK, Germany, and Italy, expanding access to CFTR modulators [22][23] - CASGEVY's reimbursement agreements in the U.S. have reached approximately 90% access for both Medicaid and commercial patients [23] Company Strategy and Development Direction - The company aims to expand leadership in CF, accelerate adoption of CASGEVY, and grow JOURNAVX while advancing its renal franchise [6][29] - The renal pipeline is emerging as a key growth engine, with povetacicept positioned to address significant unmet needs in IgA nephropathy and membranous nephropathy [10][29] - The company is focused on commercial execution and innovation to drive sustained growth across multiple serious disease areas [6][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver on significant opportunities and drive sustained growth through commercial execution and innovation [6][40] - The guidance for 2026 anticipates total company revenue in the range of $12.95 billion to $13.1 billion, representing 8%-9% growth versus the prior year [38] - The company expects combined non-GAAP operating expenses to be in the range of $5.65 billion to $5.75 billion as it continues to invest in its late-stage clinical pipeline [39] Other Important Information - The company has initiated a rolling BLA submission for povetacicept, with expectations for expedited regulatory review [11] - The company is committed to maintaining comprehensive patient support programs to facilitate access to its therapies [29] Q&A Session Summary Question: Concerns about hypogammaglobulinemia adverse events related to povetacicept - Management indicated that while BAFF/APRIL inhibitors may decrease IgG levels, data from the RUBY-3 study showed no serious adverse events or infections associated with low IgG levels, suggesting a favorable benefit-risk profile [42][44] Question: Guidance details for CF component and ALYFTREK - Management provided total revenue guidance of $12.95 billion to $13.1 billion, with a non-CF contribution of $500 million or more, but did not break down specifics for ALYFTREK versus other products [49][51] Question: Payer access and reimbursement for povetacicept - Management reported positive engagements with payers, having conducted 74 meetings covering over 210 million lives, indicating strong interest in the upcoming products [55][60] Question: Expected results on proteinuria for povetacicept - Management emphasized the importance of magnitude of proteinuria response, referencing a 56% reduction seen in the RUBY-3 study as a benchmark for expected outcomes [62][64] Question: Differentiation of povetacicept in generalized myasthenia gravis - Management highlighted the engineered profile of povetacicept, which offers better potency and pharmacokinetics compared to existing treatments, positioning it as a promising option in a crowded market [68][70]

Financial Data and Key Metrics Changes - In Q4 2025, total revenue reached $3.2 billion, a 10% increase compared to Q4 2024, while full-year revenue was $12 billion, reflecting a 9% growth versus 2024 [32][33] - Non-GAAP net income for Q4 2025 was $1.3 billion, up 24% year-over-year, resulting in earnings per share of $5.03, a 26% increase compared to the prior year [37] - The company ended 2025 with $12.3 billion in cash, cash equivalents, and marketable securities, positioning it well for future investments [37] Business Line Data and Key Metrics Changes - Cystic fibrosis (CF) therapies generated full-year 2025 growth of 7% globally, with U.S. CF revenue growing 11% year-over-year [32][33] - CASGEVY achieved $54 million in revenue in Q4 and $116 million for the full year 2025, indicating strong patient initiations and first cell collections [34] - JOURNAVX delivered $27 million in sales in Q4 and $60 million for the full year, with significant growth in quarterly prescriptions since its launch [34][35] Market Data and Key Metrics Changes - The CF population has seen a 3% annual increase over the last five years, contributing to revenue growth [20] - In Europe, reimbursement for ALYFTREK has been secured in key countries, enhancing market access [21] - The company has engaged with payers covering over 210 million lives regarding the renal pipeline, indicating strong interest and education on IgAN [60] Company Strategy and Development Direction - The company aims to expand leadership in CF, accelerate adoption of CASGEVY, and grow JOURNAVX while advancing its renal franchise [6][29] - The renal pipeline is expected to rival the scale of the CF business, with a focus on patient-centric approaches and securing reimbursement [29][30] - The company is committed to serial innovation and comprehensive patient support programs to enhance access to its therapies [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver sustained growth through commercial execution and innovation [6] - The guidance for 2026 anticipates total revenue in the range of $12.95 billion to $13.1 billion, representing 8%-9% growth versus the prior year [38] - The company expects combined non-GAAP operating expenses to be in the range of $5.65 billion to $5.75 billion as it continues to invest in its late-stage clinical pipeline [39] Other Important Information - The company has initiated a rolling BLA submission for povetacicept in IgAN, with breakthrough therapy designation granted by the FDA [11][12] - The company plans to double the size of its field force for JOURNAVX in Q2 2026 to drive prescription growth [26] Q&A Session Summary Question: Concerns about hypogammaglobulinemia adverse events related to pove - Management indicated that while low IgG levels are expected, data from the RUBY-3 study showed no serious adverse events or infections associated with low IgG levels, suggesting a favorable benefit-risk profile [43][44] Question: Guidance details for CF component and ALYFTREK performance - Management provided total revenue guidance of $12.95 billion to $13.1 billion, with a non-CF contribution of $500 million or more, while noting strong international launch contributions for ALYFTREK [49][51][52] Question: Payer access and reimbursement for pove - Management reported positive engagements with payers, indicating strong interest in the product and ongoing discussions to ensure access [59][60] Question: Expected results on proteinuria for pove - Management emphasized the importance of proteinuria response magnitude, referencing RUBY-3 results as a benchmark for expected outcomes in the RAINIER trial [62][64] Question: Rationale for studying pove in generalized myasthenia gravis - Management highlighted the significant patient population and limitations of current treatments, positioning pove as a potentially superior option due to its mechanism of action [70][72]

Financial Data and Key Metrics Changes - In Q4 2025, total revenue reached $3.2 billion, a 10% increase compared to Q4 2024. For the full year 2025, total revenue was $12 billion, reflecting a 9% increase versus 2024 [33] - Full year 2025 growth in cystic fibrosis (CF) therapies was 7% globally, with U.S. CF revenue growing 11% year-over-year [34] Business Line Data and Key Metrics Changes - CASGEVY generated $54 million in revenue in Q4 and $116 million for the full year 2025, with continued momentum in patient initiations and first cell collections [34] - JOURNAVX delivered $27 million in sales in Q4 and $60 million for the full year, showing substantial growth in quarterly prescriptions since its launch [34] Market Data and Key Metrics Changes - Internationally, CF revenue grew 2% year-over-year, driven by the penetration of KAFTRIO and contributions from ALYFTREK, partially offset by a $200 million decline in Russia sales [34] - The company secured reimbursement for ALYFTREK in key European countries, enhancing access for patients [21] Company Strategy and Development Direction - The company aims to expand leadership in CF, accelerate adoption of CASGEVY, and grow JOURNAVX while advancing its renal franchise, starting with povetacicept in IgAN [5] - The renal pipeline is expected to become a key growth engine, potentially rivaling the scale of the CF business [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver sustained growth through commercial execution and innovation across multiple serious disease areas [5] - The guidance for 2026 anticipates total company revenue in the range of $12.95 billion to $13.1 billion, representing 8%-9% growth versus the prior year [39] Other Important Information - The company ended 2025 with $12.3 billion in cash, cash equivalents, and marketable securities, positioning it well for future investments [38] - The fourth quarter gross margin was 85.7%, reflecting the product mix and investments in manufacturing optimization [35] Q&A Session Summary Question: Concerns about hypogammaglobulinemia adverse events related to povetacicept - Management indicated that while BAFF/APRIL inhibitors may decrease IgG levels, data from the RUBY-3 study showed no serious adverse events or infections associated with low IgG levels, suggesting a favorable benefit-risk profile [44][45] Question: Guidance details for CF component relative to ALYFTREK and TRIKAFTA - Management provided total revenue guidance of $12.95 billion to $13.1 billion, with a non-CF contribution of $500 million or more, but did not break down specifics for ALYFTREK versus other products [52] Question: Payer access and reimbursement for povetacicept - Management reported positive engagement with payers, having conducted 74 engagements covering over 210 million lives, indicating strong interest in the upcoming products [62] Question: Expected results on proteinuria for povetacicept - Management highlighted that a significant reduction in proteinuria, similar to the RUBY-3 study results, would be clinically meaningful and important for long-term outcomes [66] Question: Mix between retail and hospital settings for JOURNAVX - Management noted that the prescription mix concluded at about 50/50 between retail and hospital settings in 2025, with expectations for a shift towards retail in the future [83]