10-K 0000875320-26-000056 (2026-02-13) vs 10-K 0000875320-25-000053 (2025-02-13)
| Section | Compared text | Words now | Changed |
|---|
| Risk Factors | Item 1A | 9,755 |
91.5% |
| MD&A | Item 7 | 7,976 |
86.4% |
| Legal Proceedings | Item 3 | 17 |
not compared |
| Accounting Policies | 10-K text (note not found) | 0 |
not compared |
The redline: what was cut and what was added
In each section, the paragraph that changed most, marked against last year's 10-K:
cut words struck through, new words highlighted and underlined.
MD&A 217 words changed in this paragraph; it is 37% similar to last year's version.
Expenses Total Revenues In 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY. Cost of Sales Our cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements. Total R&D and SG&A Our total research and development (“R&D”), (“R&D”) and selling, general and administrative (“SG&A”) Expenses expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024 as compared to $4.3 billion in 2023, 2024, primarily due to continued increased investment to support additional therapies in mid-to-late stage development commercialize our new products and increased commercial investments to support launches of advance our therapies globally. R&D pipeline. AIPR&D Expenses In 2024, total 2025, our acquired in-process research and development expenses (“AIPR&D”) of $4.6 billion $133.0 million included various upfront and milestone payments related to our collaboration and in- licensing arrangements. In 2024, AIPR&D included $4.4 billion related to resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”). Cost (“Alpine”), which was accounted for as an asset acquisition. Cash Our total cash, cash equivalents and marketable securities increased to $12.3 billion as of sales were 14% of our net product revenues in 2024 December 31, 2025 as compared to 13% in 2023, with the increase $11.2 billion as of December 31, 2024 primarily due to costs associated with CASGEVY. cash flows provided by our operating activities partially offset by repurchases of our common stock.
Source: Item 7, 10-K 0000875320-26-000056 vs Item 7, 10-K 0000875320-25-000053
Risk Factors 96 words changed in this paragraph; it is 31% similar to last year's version.
We are subject to ongoing tax audits in various jurisdictions, and local tax authorities may disagree with certain positions we have taken and assess additional taxes. We regularly assess the probable outcomes of these audits to determine the appropriateness of our tax provision, and we have established contingency reserves for material tax exposures. However, there can be no assurance that we will accurately predict the outcomes of these disputes or other tax audits or that issues raised by tax authorities will be resolved at a financial cost that does not exceed our related reserves and the actual outcomes of these disputes and other tax audits could have a material impact on our results of operations or financial condition.
Source: Item 1A, 10-K 0000875320-26-000056 vs Item 1A, 10-K 0000875320-25-000053
Every change, by type
Sentences and paragraphs of VRTX's Risk Factors and MD&A, 10-K 2026-02-13 against 10-K 2025-02-13.
Each links to the text at sec.gov.
Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier
(may, could, will, not, significant, material…). A year or date rolling forward is not counted.
The full word list
adverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, would
AddedRisk Factors
Investing in our common stock involves a high degree of risk, and you should carefully consider the risks and
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedRisk Factors
uncertainties described below in addition to the other information included or incorporated by reference in this Annual
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedRisk Factors
Report on Form 10-K. If any of the following risks or uncertainties occur, our business, financial condition or results of
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedRisk Factors
Our success depends on our ability to develop and commercialize additional medicines.
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AddedRisk Factors
We invest significant resources in research and development to discover and develop transformative medicines for
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedRisk Factors
people with serious diseases. Product development is highly uncertain and expensive. Product candidates may appear
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AddedRisk Factors
promising in research and development but may fail to reach commercial success for many reasons, including:
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AddedRisk Factors
•competition based on, among other factors, safety, efficacy, patient convenience, pricing and reimbursement.
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AddedRisk Factors
Substantially all our net product revenues have been derived from the sale of our CF medicines. We may be unable to
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedRisk Factors
sustain or increase revenues from sales of our CF medicines in the future for any number of reasons, including the potential
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedRisk Factors
introduction of competitive products or the inability to successfully develop and commercialize next-generation medications
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AddedRisk Factors
or medicines to treat people with CF who cannot benefit from our current CF medicines. Our concentrated source of revenue
Read it in 10-K 2026-02-13 at sec.gov ↗
RemovedRisk Factors
Investing in our common stock involves a high degree of risk, and you should carefully consider the risks and uncertainties described below in addition to the other information included or incorporated by reference in this Annual Report on Form 10-K. If any of the following risks or uncertainties actually occurs, our business, financial condition or results of operations would likely suffer, possibly materially. In that case, the trading price of our common stock could decline.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
Our business is subject to numerous risks and uncertainties, discussed in more detail in the following section. These risks include, among others, the following key risks:
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•If we are not successful in commercializing CASGEVY, our revenue growth could be limited and our business could be materially harmed.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•If our competitors bring products with superior product profiles to market, our products may not be competitive, and our revenues could decline.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•If physicians and patients do not accept our products, or if patients do not remain on treatment or comply with their prescribed dosing regimen, our product revenues would decline in future periods.
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RemovedRisk Factors
•Cell and genetic therapies face increased scrutiny from the public and medical communities and commercial success will depend, in part, upon the acceptance of those communities.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•Government and other third-party payors seek to contain costs of health care through legislative and other means. If they fail to provide coverage and adequate reimbursement rates for our products, our revenues will be harmed.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•We may experience pricing pressure on our products, which could reduce our revenues and future profitability.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•Current health care laws and regulations in the U.S. and future legislative or regulatory reforms to the U.S. health care system may affect our ability to commercialize our marketed products profitably.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•We have experienced challenges commercializing products outside of the U.S., and our future revenues will be dependent on our ability to obtain adequate reimbursement for our products in ex-U.S. markets.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•Insurance coverage and reimbursement of our cell or genetic therapies is uncertain.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedRisk Factors
•Our product candidates remain subject to clinical testing and regulatory approval, and our future success is dependent on our ability to successfully develop additional product candidates for both CF and non-CF indications.
Read it in 10-K 2025-02-13 at sec.gov ↗
RewordedRisk Factors
If we discover safety or efficacy issues with any of our products or if we fail to comply with continuing U.S. and applicable foreign regulations, products, commercialization efforts for the product could be negatively affected, the approved product could lose its approval, and our business could be materially harmed.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
Results In addition, results of our clinical trials and findings from our nonclinical studies, including toxicology findings in nonclinical studies conducted concurrently with clinical trials, could lead to abrupt changes in our development activities, including the possible cessation of development activities associated with a particular product candidate or program.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
We have adopted provisions in Provisions of our articles of organization and organization, by-laws and are subject to Massachusetts corporate state laws that may frustrate any attempt to remove or replace members of our board or to effectuate certain types of business combinations involving us.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
This Annual Report on Form 10-K, including the descriptions of our Business set forth in Part I, Item 1, our Risk Factors set forth in Part I, Item 1A, and our Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in Part II, Item 7, contains forward-looking statements.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
If we are unable to sustain and grow or increase revenues from sales of our CF medicines, our business would be materially harmed and or if we do not meet the market price of our common stock would likely decline.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
We have adopted provisions in our articles of organization and by-laws and are subject to Massachusetts corporate laws that may frustrate any attempt to remove or replace members of our board or to effectuate certain types of business combinations involving us.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could adversely affect our business, result in fines and/or criminal penalties, and damage our reputation. data.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
Our effective tax rate fluctuates, and changes in tax laws, regulations and treaties, unfavorable resolution to the tax positions we have taken or exposure to additional income tax liabilities could have a material impact on our future taxable income.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
The We face additional risks that we face in connection with our current collaborations, including with CRISPR, Moderna, Entrada, and Zai, and any future collaborations, include the following:
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedRisk Factors
A breakdown or breach of our information technology systems systems, or unauthorized access to confidential information could subject us to liability or interrupt the operation of our business.
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RewordedRisk Factors
If we are not able to successfully develop and commercialize additional products operate without infringing upon intellectual property rights of third parties, our business could be materially harmed.
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RewordedRisk Factors
This would increase our reliance on that manufacturer or require us to obtain a license from that manufacturer to have our products or product candidates manufactured by other suppliers utilizing the same process.
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AddedMD&A
We are a global biotechnology company that invests in scientific innovation to create transformative medicines for
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
people with serious diseases, with a focus on specialty markets. We have approved medicines for cystic fibrosis (“CF”),
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
sickle cell disease (“SCD”), transfusion dependent beta thalassemia (“TDT”), and acute pain, and we continue to serially
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
innovate and advance next-generation clinical and research programs in these areas. Our mid- and late-stage clinical pipeline
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
includes programs across a range of modalities in additional serious diseases, including IgA nephropathy, APOL1-mediated
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
kidney disease, neuropathic pain, type 1 diabetes, primary membranous nephropathy, autosomal dominant polycystic kidney
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AddedMD&A
Collectively, our five CF medicines, led by TRIKAFTA/KAFTRIO, are being used to treat nearly three quarters of the
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
people with CF in the U.S., Europe, Australia, and Canada. ALYFTREK, our newest CF medicine, is approved in the United
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
States (the “U.S.”), the United Kingdom (the “U.K.”), the European Union (the “E.U.”), Canada, New Zealand, Switzerland,
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
CASGEVY, our ex-vivo, non-viral CRISPR/Cas9 gene-edited cell therapy, is approved in the U.S., the E.U., the U.K.,
Read it in 10-K 2026-02-13 at sec.gov ↗
AddedMD&A
the Kingdom of Saudi Arabia (“Saudi Arabia”), the Kingdom of Bahrain (“Bahrain”), Qatar, the United Arab Emirates (the
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AddedMD&A
JOURNAVX, our selective non-opioid NaV1.8 pain signal inhibitor, is approved in the U.S. for the treatment of people
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RemovedMD&A
We are a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases, with a focus on specialty markets. We have seven approved medicines: five that treat the underlying cause of cystic fibrosis (“CF”), a life-threatening genetic disease, one that treats severe sickle cell disease (“SCD”) and transfusion dependent beta thalassemia (“TDT”), life shortening inherited blood disorders, and one that treats moderate-to-severe acute pain. Our clinical-stage pipeline includes programs in CF, SCD, beta thalassemia, acute and peripheral neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy and other autoimmune renal diseases and cytopenias, type 1 diabetes, myotonic dystrophy type 1, and autosomal dominant polycystic kidney disease.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
In December 2024, the U.S. Food and Drug Administration (the “FDA”) approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), our once-daily next-in-class triple combination for the treatment of people with CF 6 years of age and older, and our fifth CF medicine. Collectively, our five medicines, led by TRIKAFTA/KAFTRIO (elexacaftor/tezacaftor/ivacaftor and ivacaftor), are being used to treat nearly three quarters of the approximately 94,000 people with CF in the U.S., Europe, Australia, and Canada. Through approvals of new medicines, label expansions, and expanded reimbursement, we are focused on increasing the number of people with CF who are eligible and able to receive our medicines. In December 2024, the FDA approved the expanded use of TRIKAFTA for the treatment of people with CF 2 years of age and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (“CFTR”) gene or a mutation that is responsive to TRIKAFTA. With this approval, 94 additional non-F508del CFTR mutations have been added to the TRIKAFTA label, and approximately 300 additional people with CF in the U.S. are now eligible for TRIKAFTA. In addition, we are evaluating our CF medicines in additional patient populations, including younger children, with the goal of having small molecule treatments for all people who have at least one mutation in their CFTR gene that is responsive to our CFTR modulators. We also are pursuing messenger ribonucleic acid (“mRNA”) and genetic therapies for people with CF who do not make full-length CFTR protein and, as a result, cannot benefit from our current CF medicines.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
CASGEVY (exagamglogene autotemcel), our ex-vivo, non-viral CRISPR/Cas9 gene-edited cell therapy, is approved in the U.S., the European Union (“E.U.”), the United Kingdom (“U.K.”), the Kingdom of Saudi Arabia (“Saudi Arabia”), the Kingdom of Bahrain (“Bahrain”), the United Arab Emirates (the “UAE”), Switzerland and Canada for the treatment of people 12 years of age and older with SCD or TDT. We estimate approximately 60,000 people with severe SCD or TDT are or could become eligible for CASGEVY in the U.S., Canada, Europe, Saudi Arabia, and Bahrain.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
In January 2025, the FDA approved JOURNAVX, our selective non-opioid NaV1.8 pain signal inhibitor, for the treatment of people with moderate-to-severe acute pain. We have begun our commercial launch of JOURNAVX in the U.S. for eligible adults. In addition, we are enrolling and dosing patients in a Phase 3 clinical trial evaluating suzetrigine for the treatment of diabetic peripheral neuropathy, a common form of peripheral neuropathic pain. In December 2024, we announced Phase 2 clinical trial results showing that treatment with suzetrigine demonstrated a statistically significant and clinically meaningful within-group reduction in pain on the numeric pain rating scale for people with lumbosacral radiculopathy (“LSR”), a form of peripheral neuropathic pain. The clinical trial also included a placebo reference arm, which showed a similar within-group reduction. Suzetrigine was safe and generally well-tolerated in the Phase 2 clinical trial. We hypothesize that a high placebo response in this clinical trial led to a lack of separation of the suzetrigine and placebo response curves. We believe we can innovate in pain clinical trial design to better control the placebo effect, and succeed in pivotal development with suzetrigine. We plan to advance suzetrigine into pivotal development in LSR, pending discussions with regulators on trial design and the regulatory package.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
We expect to grow our CF business by increasing the number of people with CF who are eligible and able to receive our medicines. We have revised estimates for the number of people with CF in the U.S., Europe, Australia, and Canada from approximately 92,000 to approximately 94,000 people. Additionally, we continue to secure formal reimbursement in multiple additional countries that collectively comprise approximately 15,000 additional people with CF. Approximately 10,000 of those additional people with CF are eligible for treatment with CFTR modulators. We previously served many of these markets through named patient sales.
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RemovedMD&A
•In December 2024, the FDA approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), the once-daily next-in-class combination CFTR modulator for the treatment of people with CF 6 years of age and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to ALYFTREK, which includes a total of 303 CFTR mutations. Regulatory submissions for ALYFTREK, including in the U.K., the E.U., Canada, Switzerland, Australia, and New Zealand, are currently under review.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
•In December 2024, the FDA approved the expanded use of TRIKAFTA for the treatment of people with CF with 94 additional non-F508del CFTR mutations. TRIKAFTA is now approved in the U.S. for a total of 272 CFTR mutations. We have also submitted regulatory applications to the European Medicines Agency (“EMA”) for TRIKAFTA/KAFTRIO for the treatment of people with CF and rare responsive mutations.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
•We entered into an extended long-term reimbursement agreement with NHS England providing access to KAFTRIO, SYMKEVI and ORKAMBI, and continued access to KALYDECO, for existing and future eligible CF patients in England. We have entered into similar reimbursement agreements in Wales, Northern Ireland and Scotland. These reimbursement agreements include access to any future license extensions of these medicines.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
•We have activated more than 50 authorized treatment centers globally, and more than 50 patients have initiated cell collection. We expect significant growth in the number of new patients initiating cell collection throughout 2025.
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RemovedMD&A
•The Italian Medicines Agency has approved early access for CASGEVY, on a case-by-case basis, for the treatment of people with TDT and SCD.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
•In January 2025, the FDA approved JOURNAVX for the treatment of moderate-to-severe acute pain in adults. We are working to secure broad stocking agreements for JOURNAVX with national retail pharmacies and regional pharmacy chains. We expect to begin shipping JOURNAVX to pharmacies nationwide by the end of February, with retail availability beginning shortly thereafter.
Read it in 10-K 2025-02-13 at sec.gov ↗
RemovedMD&A
•We expect that JOURNAVX will be qualified for the add-on payment under the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act, which provides for a separate payment in the hospital outpatient or surgical center setting for FDA-approved non-opioid treatments for pain.
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RewordedMD&A
Expenses Total R&D and SG&A Our total research and development (“R&D”), (“R&D”) and selling, general and administrative (“SG&A”) Expenses expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024 as compared to $4.3 billion in 2023, 2024, primarily due to continued increased investment to support additional therapies in mid-to-late stage development commercialize our new products and increased commercial investments to support launches of advance our therapies globally. R&D pipeline.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedMD&A
Salary and benefits $ 686.7 $744.8 8% $686.7 16% $ 590.9 24% $ 475.1 $590.9 Stock-based compensation expense 320.6 2% 313.7 20% 262.5 23% 213.9 Compensation expense for cash-settled — ** 151.9 ** — unvested Alpine equity awards 151.9 ** — ** — Outsourced services and other direct expenses 1,493.5 21% 1,239.1 0% 1,238.7 36% 912.9 Infrastructure costs 522.7 20% 434.4 19% 365.2 17% 311.7 Total development expenses $ 2,825.8 $3,081.6 9% $2,825.8 15% $ 2,457.3 28% $ 1,913.6 $2,457.3 ** Not meaningful
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RewordedMD&A
ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our discussion and analysis of our financial condition and results of operations for 2025 as compared to 2024 are
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedMD&A
For an asset acquisition involving rights to intellectual property related to in-process research and development that is not yet associated with a product that has achieved regulatory approval, we generally expense our upfront payment to AIPR&D, because there is no alternative future use for the asset that was acquired.
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RewordedMD&A
ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedMD&A
Selling, general and administrative expenses increased by 29% 20% in 2024 2025 as compared to 2023, 2024, primarily due to increased commercial investments to prepare for the launch of JOURNAVX and support the launch of CASGEVY, and stock-based compensation expense.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedMD&A
As part of our business strategy, we seek to acquire technologies, products, product candidates and other technologies and businesses that are aligned with our corporate and research and development strategies and complement and advance our ongoing research and development efforts.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedMD&A
We enter into arrangements with third parties, including collaboration and licensing arrangements, for the development, manufacture and commercialization of products, product candidates, and other technologies that have the potential to complement our ongoing research and development efforts.
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RewordedMD&A
We also conduct all research, development, manufacturing and commercialization activities relating to other product candidates and products under the CRISPR JDCA throughout the world subject to CRISPR’s reserved right to conduct certain activities.
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RewordedMD&A
We believe that our application of the following accounting policies, each of which requires significant judgments and estimates on the part of management, are the most critical to aid in fully understanding and evaluating our reported financial results:
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedMD&A
As part of our business strategy, we seek to acquire products, product candidates and other technologies and businesses that are aligned with our corporate and research and development strategies and complement and advance our ongoing research and development efforts.
Read it in 10-K 2026-02-13 at sec.gov ↗
RewordedMD&A
Cash used in operating activities was $492.6 million in 2024 as compared 2024, primarily due to cash provided by operating activities our acquisition of $3.5 billion in 2023. Alpine partially
Read it in 10-K 2026-02-13 at sec.gov ↗
