Vertex Pharmaceuticals (VRTX) 10-K risk factor changes: FY2025 vs FY2024
The 2025-12-31 10-K against the 2024-12-31 one, compared heading by heading and sentence by sentence.
Item 1A147 rewritten711 added692 removed19 unchanged
All filing items1,905 rewritten3,726 added1,598 removed547 unchanged
Summary
counted, not written
- Item 1A lists 32 risk factor headings: 21 new, 5 reworded and 6 unchanged since FY2024. 37 headings from FY2024 no longer appear.
- Sentence by sentence, 3,726 added, 1,598 removed, 1,905 rewritten and 547 unchanged across 22 items that differ.
New Item 1A headings (21)
- Report on Form 10-K. If any of the following risks or uncertainties occur, 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.
- Our success depends on our ability to develop and commercialize additional medicines.
- Our business is substantially dependent on the success of our CF medicines.
- We may not be able to increase or maintain CASGEVY product revenues.
- Risks Related to Commercialization revenues, and results of operations.
- Competing products and technological advances from our competitors may negatively affect our business and market position.
- The data from our product development activities may not support advancement or regulatory approval of our product candidates, or label expansions for our marketed products, or provide sufficient data to support the successful commercialization of our approved products.
- If we fail to successfully conduct our clinical activities, our clinical trials or future regulatory approvals may be delayed or denied.
- The extensive regulatory framework governing the health care industry could adversely affect our ability to obtain approval and market our medicines and failure to comply with these regulations could result in fines, penalties or other non-monetary remedies.
- Commercialization of our products requires that we operate in compliance with applicable health care laws, including laws regulating promotional activities, prohibiting fraud and abuse and requiring reporting of government pricing information.
- If we are unable to obtain, maintain and enforce our intellectual property rights, our business could be harmed.
- If we are not able to operate without infringing upon intellectual property rights of third parties, our business could be harmed.
- We are subject to various and evolving laws and regulations governing the privacy and security of personal data.
- Risks Related to Our Operations including at our third-party providers.
- If we are unable to maintain and expand our supply chain and manufacturing capabilities, our ability to develop our product candidates and manufacture our products would be harmed.
- Reliance on third-party relationships could adversely affect our business.
- A breakdown or breach of our information technology systems, or unauthorized access to confidential information could adversely affect our business.
- Our operations may be disrupted by the occurrence of a natural disaster, catastrophic event, or by other serious accidents occurring at our facilities.
- Our business development strategy, including strategic transactions and collaborations, may not be successful, and there may be delays or failures in realizing the anticipated benefits of these activities.
- Changes in foreign currency rates, interest rate risks, the value of our investment portfolio, and inflation affect our results of operations and financial condition.Interest rates
- Our stock price is volatile.
Removed Item 1A headings (37)
- If we are unable to successfully develop and commercialize additional products, our business could be materially harmed.
- If we are unable to sustain and grow revenues from sales of our CF medicines, our business would be materially harmed and the market price of our common stock would likely decline.
- If we are not successful in commercializing CASGEVY, our revenue growth could be limited and our business could be materially harmed.
- If our competitors bring products with superior product profiles to market, our products may not be competitive, and our revenues could decline.
- 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.
- 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.
- 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.
- We may experience pricing pressure on our products, which could reduce our revenues and future profitability.
- 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.
- 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.
- Insurance coverage and reimbursement of cell and genetic therapies is uncertain.
- 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.
- If we are unable to obtain or are delayed in obtaining regulatory approval, we may incur additional costs, experience delays, or be unable to commercialize our product candidates.
- If clinical trials are prolonged or delayed, our development timelines for the affected development program could be extended, our costs to develop the product candidate could increase and the competitive position of the product candidate could be adversely affected.
- Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval.
- Enrollment for clinical trials for our cell and gene therapies may face additional and unique challenges and adverse developments associated with these clinical trials could result in action by regulatory bodies, including revised requirements for approval.
- If regulatory authorities interpret any of our conduct, including our marketing practices, as being in violation of applicable health care laws, including fraud and abuse laws, laws prohibiting false and misleading promotion, disclosure laws or other similar laws, we may be subject to civil or criminal penalties.
- If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the U.S., we could be subject to additional reimbursement requirements, penalties, sanctions, and fines that could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
- If our processes and systems are not compliant with regulatory requirements, we could be subject to restrictions on marketing our products or could be delayed in submitting regulatory filings seeking approvals for our product candidates.
- The regulatory approval process for our cell or genetic therapies involves additional consultations with regulatory agencies, costs, and potentially longer timelines as compared to those for small molecules.
- 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.
- If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
- We may face manufacturing, supply, and distribution difficulties, among other challenges, delays, or interruptions, including at our third-party providers.
- We rely on third parties to conduct pre-clinical work, clinical trials and other activities, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such studies and/or trials or failing to satisfy regulatory requirements.
- We face risks in connection with existing and future collaborations with respect to the development, manufacture and commercialization of our products and product candidates.
- Our ability to execute on our long-term strategy depends in part on our ability to engage in transactions and collaborations with other entities that add to our pipeline or provide us with new commercial opportunities.
- We may not realize the anticipated benefits of existing or future acquisitions of businesses or technologies, and the integration following any such acquisition may disrupt our business and management.
- If our patents do not protect our products or our products infringe third-party patents, we could be subject to litigation which could result in injunctions preventing us from selling our products, substantial damages, or circumvention of our patents by third parties.
- Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes that are inherently costly and unpredictable.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- A breakdown or breach of our information technology systems could subject us to liability or interrupt the operation of our business.
- We rely on third parties to carry out our operations. Failure to maintain our third-party relationships or challenges at or with these third parties could materially harm our business.
- If our facilities were to experience a catastrophic loss, our operations would be seriously harmed.
- Our stock price may fluctuate.
- Our quarterly operating results are subject to significant fluctuation.
- We expect that results from our clinical development activities and the clinical development activities of our competitors will continue to be released periodically, and may result in significant volatility in the price of our common stock.
- Issuances of additional shares of our common stock could cause the price of our common stock to decline.
Reworded Item 1A headings (5)
- If we are unable to successfully
[removed: develop, obtain approval][added: develop] and commercialize[removed: treatments][added: medicines] for acute and neuropathic pain, our business could be materially harmed. - If we discover safety [added: or efficacy] issues with any of our
[removed: products or if we fail to comply with continuing U.S. and applicable foreign regulations,][added: products,] commercialization efforts for the product could be negatively affected, the approved product could lose its approval, and our business could be materially harmed. - Our effective tax rate fluctuates, and changes in tax laws, regulations and treaties, unfavorable resolution to the tax positions we have
[removed: taken or][added: taken, and] exposure to additional income tax liabilities could have a material impact on our future taxable income. - Future indebtedness could materially and adversely affect our financial condition, and the terms of our credit agreements impose restrictions on our
[removed: business, reducing our operational flexibility and creating default risks.][added: business.] - The use of social media platforms
[removed: and artificial intelligence tools]presents risks and challenges.
A heading is new when no FY2024 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2025; struck-through words were in FY2024. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS
147 rewritten, 711 added, 692 removed, 19 unchanged
*Investing in our common stock involves a high degree of risk, and you should carefully consider the risks [removed: and uncertainties described below in addition to the other information included or incorporated by reference in this Annual Report on Form 10-K.][added: and*]
If any of the following risks or uncertainties [removed: actually occurs,] [added: occur,] our business, financial condition or results [removed: of operations would likely suffer, possibly materially.][added: of*]
Risks Related to Our [removed: Business][added: Business and Products]
[removed: -] If we are [removed: unable] [added: not able] to successfully develop and commercialize additional [removed: products,] [added: medicines,] our business [removed: could] [added: would] be materially [removed: harmed.]
[removed: - If] [added: If] we are unable to successfully [removed: develop, obtain approval] [added: develop] and commercialize [removed: treatments] [added: medicines] for acute and neuropathic pain, our business [removed: could be materially harmed.][added: could]
[removed: - If we discover safety issues with any of our products or if we fail to comply with continuing U.S. and applicable foreign regulations, commercialization efforts for the product could be negatively] [added: negatively] affected, the approved product could lose its approval, and our business could be materially [removed: harmed.][added: harmed.]
Risks Related to [removed: Development and Clinical Testing of Our Products and] Product [removed: Candidates][added: Development]
[removed: Risks Related to Government Regulation][added: *Government Regulation*.”]
[removed: Risks Related to Supply, Manufacturing] [added: property, manufacturing capabilities] and [removed: Reliance] [added: supply chain, foreign exchange risks, and reliance] on [removed: Third Parties][added: third parties, risks associated]
[removed: - We] [added: We] may face manufacturing, supply, and distribution [added: delays,] difficulties, [added: and disruptions,] among other [removed: challenges, delays, or interruptions, including at our third-parties.][added: challenges,]
Risks Related to [removed: Intellectual Property][added: Commercialization]
[removed: - A variety of risks associated with operating] [added: which] in [removed: foreign countries] [added: turn] could materially adversely affect our business.
[removed: - A] [added: A] breakdown or breach of our information technology [removed: systems could subject us to liability] [added: systems,] or [removed: interrupt the operation of our business.][added: unauthorized access to confidential information could]
[removed: - Our effective tax rate fluctuates, and changes in tax laws, regulations and treaties, unfavorable resolution to the tax positions] [added: positions] we have [removed: taken or] [added: taken, and] exposure to additional income tax liabilities could have a material impact on our [removed: future taxable income.][added: future]
[removed: Product candidates that may appear] promising in research and development [added: but] may fail to reach commercial success for many reasons, including:
- the failure to obtain marketing [removed: approval for the product candidate;][added: approval;]
- the inability to manufacture [removed: the product candidate] on economically feasible terms;
- the failure to gain and maintain market acceptance among physicians and patients or other members of the medical [removed: community; and]
- the failure to obtain [removed: market acceptance or] adequate [added: pricing or] reimbursement levels from third-party payors or foreign [removed: governments for such product.][added: governments; and]
Substantially all [removed: of] our net product revenues have been derived from the sale of our CF [removed: medicines over the last several years.][added: medicines.]
In [removed: addition:][added: addition, we cannot]
[removed: - global market] acceptance continues to be dependent in part on the prevalence and severity of side effects associated with the procedure by [removed: which CASGEVY is administered, including the prevalence and severity of any side effects resulting from the myeloablative preconditioning regime.]
If we discover safety [added: or efficacy] issues with any of our [removed: products or if we fail to comply with continuing U.S. and applicable foreign regulations,] [added: products,] commercialization efforts for the product could [removed: be negatively affected, the approved product could lose its approval, and our business could be materially harmed.][added: be]
[removed: The subsequent discovery or appearance of previously] unknown or underestimated [removed: problems] [added: safety or efficacy concerns] with a product could negatively affect commercial sales of the [removed: product, result in restrictions on the product or lead to the withdrawal of the product from the market.]
Each of our CF products shares at least one active pharmaceutical [removed: ingredient with another of our products.]
[removed: As a result, if] [added: If] any of our CF products were to experience safety issues or labeling modifications, [removed: our other CF products may be adversely affected.]
The [removed: reporting] [added: discovery] of [removed: adverse] safety events involving our products or public speculation about such events could [removed: cause our stock price to decline] [added: limit] or [removed: experience periods of volatility.][added: reduce]
[removed: Our approved products] may not gain or maintain market acceptance among [removed: physicians and patients] [added: physicians, patients,] or [removed: other members of] [added: payors due to various factors, including] the [removed: medical community.]
[removed: We cannot, however, predict whether future reviews by the Colorado] PDAB, or any other PDAB, will come to the same conclusion about TRIKAFTA or any of our other therapies, or the amount [removed: of any potential upper payment limit.]
[removed: The reimbursement process in ex-U.S.] markets [added: vary widely and] can take a significant time to [removed: conclude] [added: complete,] and reimbursement decisions are made on a [removed: country by country or region by region basis.][added: country-by-]
[removed: Further, many ex-U.S.] governments are introducing new legislation [removed: focusing] [added: focused] on cost containment measures [removed: in] [added: applicable to] the pharmaceutical [removed: industry.]
[removed: Failure to advance product candidates through clinical development could impair] our ability to [removed: ultimately] commercialize products, which could materially harm our [removed: business] [added: business, financial condition] and long-term prospects.
[removed: Results] [added: In addition, results] of our clinical trials and findings from [removed: our] nonclinical [removed: studies, including toxicology findings in nonclinical] studies [removed: conducted concurrently with clinical trials,] could lead to abrupt changes in our [removed: development activities, including the possible cessation of development activities associated with a particular product candidate or program.]
[removed: For example, the results from completed preclinical studies and clinical] trials may not be [removed: replicated in later clinical trials, and ongoing clinical trials for our product candidates may not be] predictive of the results [removed: we may obtain in] [added: from] later-stage clinical [removed: trials] [added: trials,] or of the likelihood of approval of a product [removed: candidate for commercial sale.]
[removed: Interim or preliminary data from a clinical trial may not be predictive of final] results from the clinical trial and are subject to the risk that one or more of the clinical outcomes may materially change as [removed: patient enrollment and treatment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease.]
[removed: Any delay in obtaining required regulatory approvals] could [removed: materially] adversely affect our ability to successfully commercialize a product candidate.
[removed: Clinical trials] [added: stage clinical trials,] are expensive and [removed: require significant operational resources.][added: resource intensive.]
[removed: -] [added: This capacity may be limited by] the number of other clinical trials [removed: ongoing] and [removed: competing] [added: commercial manufacturing ongoing] for [removed: patients in the same indication;]
[removed: - our ability to obtain and] [added: obtain,] maintain [removed: patient consents;][added: and enforce our patents is uncertain.]
[removed: Even if it is later determined] we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our [removed: actions, and have to divert significant management resources from other matters.]
*uncertainties described below in addition to the other information included or incorporated by reference in this Annual*
*Report on Form 10-K.
*operations would likely suffer, possibly materially.
Our success depends on our ability to develop and commercialize additional medicines.
We invest significant resources in research and development to discover and develop transformative medicines for
people with serious diseases.
Product candidates may appear
community;
- competition based on, among other factors, safety, efficacy, patient convenience, pricing and reimbursement.
harmed.
Our business is substantially dependent on the success of our CF medicines.
We may be unable to
sustain or increase revenues from sales of our CF medicines in the future for any number of reasons, including the potential
introduction of competitive products or the inability to successfully develop and commercialize next-generation medications
or medicines to treat people with CF who cannot benefit from our current CF medicines.
Our concentrated source of revenue
increases the risks associated with potential manufacturing or supply disruptions, safety issues that may be identified with
respect to our CF medicines, and failure to gain and/or maintain market acceptance or adequate pricing or reimbursement for
our CF medicines.
If we are unable to sustain or increase revenues from sales of our CF medicines, or if we do not meet the
expectations of investors, our business would be materially harmed and our ability to fund our operations could be adversely
affected.
be materially harmed.
A portion of the value attributed to our company by investors is based on the expected commercial success of
JOURNAVX for acute pain and on our development programs for both acute and peripheral neuropathic pain.
JOURNAVX
availability of lower-cost alternatives, and sales, marketing, pricing, and/or distribution challenges associated with
introducing a product into a highly competitive market.
Furthermore, we may not succeed in developing JOURNAVX for
additional indications or in advancing other product candidates, including NaV1.8 or NaV1.7 inhibitors, for the treatment of
acute or peripheral neuropathic pain.
Even if we obtain marketing approvals for these product candidates, they will face
significant competition and there can be no assurance of commercial success.
We may not be able to increase or maintain CASGEVY product revenues.
The future commercial success of CASGEVY depends on physicians, patients, or payors accepting it as medically
useful, cost-effective, ethical, safe, and preferred with respect to current and potential future competitive therapies, and on
payors providing adequate reimbursement.
In addition to risks generally associated with the commercialization of medicines,
the cell collection processes, manufacturing and other procedures required to manufacture and administer CASGEVY are
more complex, resource-intensive, and operationally demanding than for small molecules.
SUMMARY OF RISK 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:
- If we are unable to sustain and grow revenues from sales of our CF medicines, our business would be materially harmed and the market price of our common stock would likely decline.
- If we are not successful in commercializing CASGEVY, our revenue growth could be limited and our business could be materially harmed.
- If our competitors bring products with superior product profiles to market, our products may not be competitive, and our revenues could decline.
- 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.
- 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.
Risks Related to Pricing of Our Products
- 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.
- We may experience pricing pressure on our products, which could reduce our revenues and future profitability.
- 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.
- 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.
- Insurance coverage and reimbursement of our cell or genetic therapies is uncertain.
- 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.
- If we are unable to obtain or are delayed in obtaining regulatory approval, we may incur additional costs, experience delays, or be unable to commercialize our product candidates.
- If clinical trials are prolonged or delayed, our development timelines for the affected development program could be extended, our costs to develop the product candidate could increase and the competitive position of the product candidate could be adversely affected.
- Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval.
- Enrollment for clinical trials for our cell and gene therapies may face additional and unique challenges and adverse developments associated with these clinical trials could result in action by regulatory bodies, including revised requirements for approval.
- If regulatory authorities interpret any of our conduct, including our marketing practices, as being in violation of applicable health care laws, including fraud and abuse laws, laws prohibiting false and misleading promotion, disclosure laws or other similar laws, we may be subject to civil or criminal penalties.
- If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the U.S., we could be subject to additional reimbursement requirements, penalties, sanctions, and fines that could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
- If our processes and systems are not compliant with regulatory requirements, we could be subject to restrictions on marketing our products or could be delayed in submitting regulatory filings seeking approvals for our product candidates.
- The regulatory approval process for our cell and genetic therapies involves additional consultations with regulatory agencies, costs, and potentially longer timelines as compared to those for small molecules.
- We rely on third parties to conduct pre-clinical work, clinical trials and other activities, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such studies and/or trials or failing to satisfy regulatory requirements.
Risks Related to Business Development Activities
- We face risks in connection with existing and future collaborations with respect to the development, manufacture and commercialization of our products and product candidates.
- Our ability to execute on our long-term strategy depends in part on our ability to engage in transactions and collaborations with other entities that add to our pipeline or provide us with new commercial opportunities.
- We may not realize the anticipated benefits of existing or future acquisitions of businesses or technologies, and the integration following any such acquisition may disrupt our business and management.
- If our patents do not protect our products and our products infringe third-party patents, we could be subject to litigation which could result in injunctions preventing us from selling our products, substantial damages, or circumvention of our patents by third parties.
- Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes that are inherently costly and unpredictable.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
Risks Related to Our Operations
- If we fail to scale our operations to accommodate growth, our business may suffer.
- If we fail to attract and retain skilled employees, our business could be materially harmed.
- Failure to maintain our third-party relationships or challenges at or with these third parties could materially harm our business.
Risks Related to Financial Results and Holding Our Common Stock
- Our stock price may fluctuate and our quarterly operating results are subject to significant fluctuation.
If we are unable to successfully develop and commercialize additional products, our business could be materially harmed.
We invest significant resources in the research and development of therapies for serious diseases and conditions, including CF, SCD, TDT, acute and peripheral neuropathic pain, IgAN, AMKD, T1D, DM1, and ADPKD.
An excerpt. Shown here: 40 of 147 rewritten, 40 of 711 added and 40 of 692 removed. The counts are complete. For every sentence, read Item 1A. RISK FACTORS in the FY2025 filing and the FY2024 filing.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
256 rewritten, 548 added, 211 removed, 63 unchanged
*Our discussion and analysis of our financial condition and results of operations [removed: for 2024 as] [added: for* *2025* *as] compared [removed: to 2023 are discussed below.][added: to* *2024* *are*]
For a discussion of our financial condition and results of operations [removed: for 2023 as] [added: for* *2024* *as] compared [removed: to 2022, please refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2023 Annual Report on Form 10-K, except as set forth below.*][added: to* *2023, please*]
We are a global biotechnology company that invests in scientific innovation to create transformative medicines for [removed: people with serious diseases, with a focus on specialty markets.]
Collectively, our five [added: CF] medicines, led by [removed: TRIKAFTA/KAFTRIO (elexacaftor/tezacaftor/ivacaftor and ivacaftor),] [added: TRIKAFTA/KAFTRIO,] are being used to treat nearly three quarters of the [removed: approximately 94,000 people with CF in the U.S., Europe, Australia, and Canada.]
[removed: Through approvals of new medicines, label expansions,] [added: people with CF] and [removed: expanded reimbursement, we are focused on] increasing the number of people with CF [removed: who are] eligible and able to receive our medicines.
[removed: CASGEVY (exagamglogene autotemcel),] [added: CASGEVY,] our ex-vivo, non-viral CRISPR/Cas9 gene-edited cell therapy, is approved in the U.S., the [removed: 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] [added: E.U.,] the [removed: treatment of people 12 years of age and older with SCD or TDT.][added: U.K.,]
[removed: In January 2025, the FDA approved] JOURNAVX, our selective non-opioid NaV1.8 pain signal inhibitor, [added: is approved in the U.S.] for the treatment of people [removed: with moderate-to-severe acute pain.]
We [removed: have begun] [added: are continuing] our commercial launch of JOURNAVX [removed: in the U.S.] for eligible adults.
| *Cash* | [removed: | |] Our total cash, cash equivalents and marketable securities [removed: decreased] [added: increased] to [removed: $11.2] [added: $12.3] billion as of December 31, [removed: 2024] [added: 2025] as compared to [removed: $13.7] [added: $11.2] billion as of December 31, [removed: 2023] [added: 2024] primarily due to cash [removed: paid to acquire Alpine and repurchases of our common stock, partially offset by cash] flows provided by [removed: other] [added: our] operating [removed: activities. | |] [added: activities partially offset by repurchases of our common stock.] |
[removed: ][added: ]
[removed: Sickle Cell Disease] [added: sickle cell disease (“SCD”), transfusion dependent beta thalassemia (“TDT”),] and [removed: Beta Thalassemia][added: acute pain, and we continue to serially]
[removed: - CASGEVY is now approved in the U.S., the E.U., the U.K., Saudi Arabia, Bahrain, the UAE, Canada and] [added: “UAE”), Kuwait,] Switzerland [added: and Canada] for [added: the treatment of] people 12 years of age and older with SCD or TDT.
We continue to advance a diversified pipeline of potentially transformative medicines for serious diseases utilizing a [removed: range of modalities.]
- [removed: In May 2024, we acquired Alpine, whose lead compound was] [added: We are developing] povetacicept, a dual inhibitor of B cell activating factor (“BAFF”) and a proliferation-inducing [removed: ligand (“APRIL”) pathways.]
[removed: *•*Zimislecel] [added: - Zimislecel] is an [removed: allogeneic] [added: allogeneic,] stem cell-derived, fully differentiated, insulin-producing islet cell replacement therapy, [removed: using standard immunosuppression to protect the implanted cells.]
[removed: Myotonic Dystrophy Type 1][added: disease, and myotonic dystrophy type 1.]
[removed: Autosomal Dominant Polycystic Kidney Disease][added: kidney disease, neuropathic pain, type 1 diabetes, primary membranous nephropathy, autosomal dominant polycystic kidney]
Recent investments in external innovation [removed: are included below.][added: include:]
In [removed: 2024,] [added: 2025,] our net product revenues [removed: came] [added: were] primarily from the sale of our medicines for the treatment of CF.
[removed: Our CF strategy] involves continuing to develop and obtain approval and reimbursement for treatment regimens that will provide benefits to all [removed: people with CF and increasing the number of people with CF eligible and able to receive our medicines.]
[removed: We also continue to advance] [added: In addition, we are advancing] our pipeline of product candidates for the treatment of serious diseases [removed: outside of CF, SCD, TDT, and acute pain.]
Our strategy is to combine transformative advances in the understanding of causal human biology and the science of [removed: therapeutics to discover and develop innovative medicines.]
[removed: This approach includes advancing multiple compounds or] therapies from each program, spanning multiple modalities, into early clinical trials to obtain patient data that can inform [removed: selection of the most promising therapies for later-stage development, as well as to inform discovery and development efforts.]
[removed: We] believe that pursuing research in diverse areas allows us to balance the risks inherent in product development and may [removed: provide product candidates that will form our pipeline in future years.]
Discovery and development of a new pharmaceutical or biological product is a difficult and lengthy process that requires [removed: significant financial resources along with extensive technical and regulatory expertise.]
[removed: Across the industry, most potential] drug or biological products never progress into development, and most products that [removed: do] advance into development never receive [removed: marketing approval.]
[removed: We closely monitor our research] and development activities, and frequently evaluate our pipeline programs in light of new data and scientific, business and [removed: commercial insights, with the objective of balancing risk and potential.]
[removed: This process can result in rapid changes in focus and] priorities as new information becomes available and as we gain additional understanding of our ongoing programs and [removed: potential new programs, as well as those of our competitors.]
[removed: As we advance our product] candidates through clinical development toward commercialization and market and sell our approved products, we build and [removed: maintain our supply chain and quality assurance resources.]
[removed: We rely on a global network of third parties, including some in] China, and our internal capabilities to manufacture and distribute our products for commercial sale and post-approval clinical [removed: trials and to manufacture and distribute our product candidates for clinical trials.]
[removed: In addition to establishing supply chains for] each [removed: new] [added: newly] approved product, we adapt our supply chain for existing products to include additional formulations or to [removed: increase scale of production for existing products as needed.]
[removed: The processes for biological and cell and genetic therapies can] be more complex than those required for small molecule drugs and require additional investments in different systems, [removed: equipment, facilities and expertise.]
We are focused on ensuring the stability of the supply chains for our current products, as [removed: well as for our pipeline programs.]
Sales of our products depend, to a large degree, on the extent to which our products are reimbursed by third-party payors, [removed: such as government health programs, commercial insurance and managed health care organizations.]
[removed: Reimbursement for our] products, including our potential pipeline therapies, cannot be assured and may take significant periods of time to obtain.
[removed: We] dedicate substantial management and other resources to obtain and maintain appropriate levels of reimbursement for our [removed: products from third-party payors, including governmental organizations in the U.S. and ex-U.S. markets.]
[removed: In the U.S., we have worked successfully] [added: work] with [removed: third-party] [added: government and commercial] payors to [removed: promptly] obtain [added: and maintain] appropriate levels of reimbursement for our [removed: CF] medicines.
[removed: Similarly, in] [added: In] ex-U.S. markets, we seek government reimbursement for our medicines on a country-by-country or [removed: region-by-region basis,] [added: region-by-region,] as [removed: required.]
[removed: We expect to] continue to focus significant resources to expand and maintain reimbursement for our CF medicines, CASGEVY, [removed: JOURNAVX, and, ultimately, our pipeline therapies, in U.S. and ex-U.S. markets.]
As part of our business strategy, we seek to acquire technologies, products, product candidates and other businesses that [removed: are aligned with our corporate and research and development strategies and complement and advance our ongoing research and development efforts.]
OPERATIONS
*discussed below.
*refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our* *2024*
*Annual Report on Form 10-K, except as set forth below.*
people with serious diseases, with a focus on specialty markets.
We have approved medicines for cystic fibrosis (“CF”),
innovate and advance next-generation clinical and research programs in these areas.
Our mid- and late-stage clinical pipeline
includes programs across a range of modalities in additional serious diseases, including IgA nephropathy, APOL1-mediated
people with CF in the U.S., Europe, Australia, and Canada.
ALYFTREK, our newest CF medicine, is approved in the United
States (the “U.S.”), the United Kingdom (the “U.K.”), the European Union (the “E.U.”), Canada, New Zealand, Switzerland,
Australia and Israel.
the Kingdom of Saudi Arabia (“Saudi Arabia”), the Kingdom of Bahrain (“Bahrain”), Qatar, the United Arab Emirates (the
with moderate-to-severe acute pain.
| | |
| --- | --- |
| *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* *Expenses* | Our total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline. |
| *AIPR&D Expenses* | In 2025, our acquired in-process research and development expenses (“AIPR&D”) of $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 resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition. |
$0.1

$0.1
2024
2025
December 31, 2025
December 31, 2024
We expect that the number of people with CF taking our medicines will continue to grow through new approvals and
reimbursement agreements, treatment of younger patients, increased survival and expansion into additional geographies.
- ALYFTREK is reimbursed for eligible people with CF in the U.S., England, Ireland, Germany, Denmark, Northern
Ireland, Norway, Wales, Italy, Australia, New Zealand and Luxembourg.
We are working to secure access for
eligible patients in additional countries.
- In 2025, we recorded $115.8 million of CASGEVY product revenues.
This reflects 64 patients receiving infusions
of CASGEVY in 2025, including 30 people infused in the fourth quarter.
Globally, in 2025, 147 people with SCD or
TDT had their first cell collection for CASGEVY.
- As of the end of 2025, approximately 90 percent of people with SCD or TDT in the U.S. have reimbursed access to
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.
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.
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.
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.
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.
| *Revenues* | | | In 2024, our net product revenues increased to $11.0 billion as compared to $9.9 billion in 2023, primarily due to increased TRIKAFTA/KAFTRIO product revenues resulting from strong performance and demand globally, including expansions into younger age groups and label extensions, and higher net realized pricing in the U.S. | | |
| *Expenses* | | | Our total research and development (“R&D”), and selling, general and administrative (“SG&A”) expenses increased to $5.1 billion in 2024 as compared to $4.3 billion in 2023, primarily due to continued investment to support additional therapies in mid-to-late stage development and increased commercial investments to support launches of our therapies globally. In 2024, total acquired in-process research and development expenses (“AIPR&D”) of $4.6 billion included $4.4 billion related to our acquisition of Alpine Immune Sciences, Inc. (“Alpine”). Cost of sales were 14% of our net product revenues in 2024 as compared to 13% in 2023, with the increase primarily due to costs associated with CASGEVY. | | |
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.
Recent progress in activities expanding our CF business is included below:
- 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.
- 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.
- 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.
- KAFTRIO is reimbursed in all 27 countries of the E.U.
- 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.
- We entered into a reimbursement agreement with NHS England for eligible people with SCD to access CASGEVY, consistent with the reimbursement agreement reached in August 2024 with NHS England for eligible people with TDT to access CASGEVY.
- 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.
Acute Pain
*•*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.
An excerpt. Shown here: 40 of 256 rewritten, 40 of 548 added and 40 of 211 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF in the FY2025 filing and the FY2024 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
24 rewritten, 38 added, 7 removed, 5 unchanged
[removed: Financial Instruments][added: *Financial Instruments*]
[removed: The investment] portfolio is used to preserve our capital, provide adequate liquidity and earn returns commensurate with our risk appetite.
[removed: We] invest in instruments that meet the credit quality standards outlined in our investment policy, which also limits the amount of [removed: credit exposure to any one issue or type of instrument.]
[removed: These instruments primarily include securities issued by the U.S.] government and its agencies, investment-grade corporate [removed: bonds and commercial paper,] [added: bonds, asset-backed securities] and money market funds.
[removed: These] investments are primarily denominated in U.S. Dollars and none are held for trading purposes.
Substantially all of our investment portfolio consists of marketable securities with active secondary or resale markets to help [removed: ensure portfolio liquidity, and we have implemented guidelines limiting the term-to-maturity of our investment instruments.]
Since we account for these securities as available-for-sale, no gains or losses are realized due to changes in the fair value of [removed: our investments unless we sell our investments prior to maturity or incur a credit loss.]
[removed: Due to the conservative nature of these] instruments, we do not believe that the fair value of our investments has a material exposure to interest rate risk.
While we are exposed to global interest rate fluctuations, our investment portfolio is most affected by fluctuations in U.S. [removed: interest rates, which affect the interest earned on our cash, cash equivalents and marketable securities.]
[removed: Credit Agreement][added: *Credit Agreement*]
[removed: Pursuant to our credit agreement, the] applicable margin on base rate loans ranges from 0.000% to 0.500% and the applicable margin on SOFR loans ranges from [removed: 1.000% to 1.500%.]
We do not believe that changes in interest rates related to our credit agreement would have a material [removed: effect on our consolidated financial statements.]
As of December 31, [removed: 2024,] [added: 2025,] we had no principal or interest outstanding under [removed: our credit facility.]
A portion of our “Interest expense” in [removed: 2025] [added: 2026] will be dependent on whether, and to what extent, we borrow [removed: amounts under this facility.]
As a result of our foreign operations, we face significant exposure to movements in foreign currency exchange [removed: rates, primarily the Euro and British Pound against the U.S. dollar.][added: rates]
[removed: Fluctuations in the amounts] of our foreign revenues and fluctuations in foreign currency exchange rates, may have a positive or negative effect on our [removed: foreign exchange rate exposure.]
The current exposures arise primarily from cash, accounts receivable, intercompany [removed: receivables and payables, payables, and accruals, and inventories.]
We have a foreign currency management program, which is separate from our investment policy and portfolio, with the [removed: objective of reducing the effect of exchange rate fluctuations on our operating results and forecasted revenues denominated in foreign currencies.]
We [removed: currently] have cash flow hedges [removed: for the Euro, British Pound, Canadian Dollar, Swiss Franc and Australian Dollar] related to a portion of our forecasted product revenues that qualify for hedge [removed: accounting treatment under U.S. GAAP.]
[removed: We do not seek hedge accounting treatment for our foreign currency forward] contracts related to monetary assets and liabilities that impact our operating results.
[removed: As of December 31, 2024, we held] foreign exchange forward contracts that were designated as cash flow hedges with notional amounts totaling [removed: $2.9] [added: $6.1] billion [removed: representing a net asset of $142.5 million on our consolidated balance sheet.]
Although not predictive in nature, we believe a hypothetical 10% threshold reflects a reasonably possible near-term [removed: change in exchange rates.]
[removed: If the December 31, 2024 exchange rates were to change by a hypothetical 10%, the fair value] recorded on our consolidated balance sheet related to our foreign exchange forward contracts that were designated as cash [removed: flow hedges as of December 31, 2024 would change by approximately $286.0 million.]
[removed: Therefore, any change in the fair value of these contracts that would result from a hypothetical 10% change in exchange rates would be entirely offset by the change in value associated with the underlying hedged product revenues resulting in no impact on our] future anticipated earnings and cash flows with respect to the hedged portion of our forecasted product revenues.
The investment
We
credit exposure to any one issue or type of instrument.
These instruments primarily include securities issued by the U.S.
These
ensure portfolio liquidity, and we have implemented guidelines limiting the term-to-maturity of our investment instruments.
our investments unless we sell our investments prior to maturity or incur a credit loss.
Due to the conservative nature of these
interest rates, which affect the interest earned on our cash, cash equivalents and marketable securities.
Loans under this
credit agreement bear interest, at our option, at a base rate or a Secured Overnight Financing Rate (“SOFR”), plus an
applicable margin based on our consolidated leverage ratio (the ratio of our total consolidated funded indebtedness to our
consolidated EBITDA for the most recently completed four fiscal quarter period).
Pursuant to our credit agreement, the
1.000% to 1.500%.
effect on our consolidated financial statements.
our credit facility.
amounts under this facility.
between the U.S. dollar and various foreign currencies, the most significant of which is the Euro.
Fluctuations in the amounts
foreign exchange rate exposure.
receivables and payables, payables, and accruals, and inventories.
objective of reducing the effect of exchange rate fluctuations on our operating results and forecasted revenues denominated in
foreign currencies.
accounting treatment under U.S. GAAP.
We do not seek hedge accounting treatment for our foreign currency forward
As of December 31, 2025, we held
representing a net liability of $111.5 million on our consolidated balance sheet.
change in exchange rates.
If the December 31, 2025 exchange rates were to change by a hypothetical 10%, the fair value
flow hedges as of December 31, 2025 would change by approximately $608.0 million.
However, since these contracts hedge
a specific portion of our forecasted product revenues denominated in certain foreign currencies, any change in the fair value
of these contracts is recorded in “Accumulated other comprehensive (loss) income” on our consolidated balance sheets and is
reclassified to earnings in the same periods during which the underlying product revenues affect earnings.
Therefore, any
change in the fair value of these contracts that would result from a hypothetical 10% change in exchange rates would be
entirely offset by the change in value associated with the underlying hedged product revenues resulting in no impact on our
Loans under this credit agreement bear interest, at our option, at a base rate or a Secured Overnight Financing Rate (“SOFR”), plus an applicable margin based on our consolidated leverage ratio (the ratio of our total consolidated funded indebtedness to our consolidated EBITDA for the most recently completed four fiscal quarter period).
However, since these contracts hedge a specific portion of our forecasted product revenues denominated in certain foreign currencies, any change in the fair value of these contracts is recorded in “Accumulated other comprehensive income (loss)” on our consolidated balance sheets and is reclassified to earnings in the same periods during which the underlying product revenues affect earnings.
Equity Price Risk
We hold strategic equity investments in certain public and private companies, and we expect to make additional strategic equity investments in the future.
In 2024 and 2023, we recorded net losses of $9.5 million and $0.6 million, respectively, to “Other income (expense), net” in our consolidated statements of income to reflect changes in the fair value of equity investments with readily determinable fair values (including publicly traded securities).
The fair value of our equity investments in publicly traded companies was less than $50.0 million as of December 31, 2024.
To the extent that we continue to hold strategic equity investments in publicly traded companies, we expect that due to the volatility of the stock price of biotechnology companies, our “other income (expense), net” will fluctuate in future periods based on increases or decreases in the fair value of our strategic equity investments.
Item 1. BUSINESS
392 rewritten, 1,001 added, 445 removed, 77 unchanged
We are a global biotechnology company that invests in scientific innovation to create transformative medicines for [removed: people with serious diseases, with a focus on specialty markets.]
Our goal in CF is to continue to extend our leadership by developing treatment regimens that will provide benefits to all [removed: people with CF.]
[removed: Collectively, our five marketed CF medicines] [added: ivacaftor) and KALYDECO (ivacaftor),] are being used [removed: to treat] [added: by] nearly three quarters of the approximately [removed: 94,000] [added: 97,000] people with CF [removed: in the U.S., Europe, Australia, and Canada.]
[removed: VX-522 has the potential to benefit the more than 5,000] [added: To treat] people with CF [removed: in the U.S., Canada, Europe and Australia] who do not make full-length CFTR [removed: protein] [added: protein,] and [removed: therefore] [added: as a result,] cannot benefit from [added: our] CFTR [removed: modulators.]
[removed: We] estimate approximately 60,000 people with severe SCD or TDT are or could become eligible for CASGEVY in [removed: the U.S., Canada, Europe, Saudi Arabia and Bahrain.][added: these]
[removed: In January 2025, the FDA approved JOURNAVX (suzetrigine),] [added: evaluating suzetrigine,] our selective non-opioid NaV1.8 pain signal inhibitor, for the treatment of [removed: moderate-to-severe acute pain.][added: DPN, a type of peripheral]
[removed: ][added: ]
[removed: Beyond CF, SCD, TDT and pain, we] [added: We] are advancing [added: five pivotal] programs across multiple disease [removed: areas and modalities, including:][added: areas:]
- *APOL1-Mediated Kidney Disease.* We are [removed: evaluating] [added: developing] inaxaplin, [removed: our] [added: a] small molecule [removed: for the treatment] [added: inhibitor] of [removed: APOL1-mediated kidney disease (“AMKD”).][added: APOL1 as a potential]
[removed: We continue to enroll and] [added: multiple ascending] dose [removed: people with AMKD in the Phase 3] portion of the global Phase [removed: 2/3] [added: 1/2] clinical [removed: trial.][added: trial of VX-670 in people with DM1 (“GALILEO”), which]
[removed: - *IgA] [added: *•IgA] Nephropathy*.
We are enrolling and dosing patients in [removed: the] [added: a] Phase [removed: 3] [added: 2 proof-of-concept] clinical trial evaluating [removed: povetacicept in people with IgAN.][added: VX-407 (“AGLOW”)]
[removed: Z*imislecel, formerly known as VX-880,] [added: Z*imislecel] is an allogeneic stem-cell derived, fully differentiated islet cell therapy in pivotal [removed: development for the treatment of type 1 diabetes (“T1D”).]
We expect to complete [removed: enrollment and dosing in] the Phase [removed: 3] [added: 2] portion of [removed: this Phase 1/2/3] [added: the] clinical trial [removed: in 2025.][added: and to initiate the Phase]
[removed: - *Autosomal Dominant Polycystic Kidney Disease*.][added: kidney disease, neuropathic pain, type 1 diabetes, primary membranous nephropathy, autosomal dominant polycystic kidney]
[removed: Our core strategy is to discover and develop innovative medicines by combining transformative] advances in the understanding of human disease and the science of [removed: therapeutics] [added: therapeutics,] to dramatically advance human health.
[removed: That strategy focuses] [added: focus] on validated targets that address causal human biology, predictive lab assays and clinical biomarkers, rapid paths to [removed: registration and approval, and product candidates that hold the potential for transformative patient benefit.]
[removed: Our approach includes advancing multiple compounds or therapies from each program into early clinical trials to obtain patient data that] can inform selection of the most promising therapies for later stage development as well as inform our ongoing discovery and [removed: development efforts.]
[removed: We plan to continue investing to advance our strategy, fostering scientific innovation by] identifying additional product candidates through internal research efforts, and investing in business development [removed: transactions to access emerging technologies, products and product candidates.]
Our serial innovation approach is intended to increase the likelihood of successfully bringing transformative medicines to [removed: patients and to provide durable clinical and commercial success.]
We are working to ensure broad access for eligible patients [removed: with these conditions in all countries with regulatory approval.]
[removed: As we continue to invest in our serial] innovation strategy, launch new products, advance our diverse pipeline, and expand [removed: geographically, we continue to maintain a strong financial profile.][added: geographically.]
Information regarding our marketed products, including information regarding the disease area, initial approval and age [removed: group for which the therapy is approved, are set forth in the table below.]
| Disease | | [removed: |] Initial Approval | [removed: | |] Eligible Age Group(1) | [removed: | |]
| Cystic Fibrosis | | | | [removed: | | | | |]
| [removed:  |] [added: ] | | 2024 | [removed: | |] 6 years of age and older | [removed: | |]
| [removed:  |] [added: ] | [added: ] | 2019 | [removed: | |] 2 years of age and older | [removed: | |]
| [removed:  | | | 2020] [added: ] | [added: ] | [added: 2018] | [removed: 2] [added: 6] years of age and older | [removed: | |]
| [removed:  | | | 2018] [added: ] | | [added: 2015] | [removed: 6 years] [added: 1 year] of age and older | [removed: | |]
| [removed:  | | | 2018] [added: ] | | [added: 2012] | [removed: 6 years] [added: 1 month] of age and older | [removed: | |]
| Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia | | | | [removed: | | | | |]
| [removed:  |] [added: ] | | 2023 | [removed: | |] 12 years of age and older | [removed: | |]
| Acute Pain | | | | [removed: | | | | |]
| [removed:  |] [added: ] | | 2025 | [removed: | | adults | |] [added: Adults] |
[removed: CF is a life-shortening genetic disease caused by a defective or missing CFTR] [added: receptor (“CFTR”)] protein resulting from mutations in the CFTR gene.
[removed: The absence of working CFTR protein results in poor] flow of salt and water into and out of cells in a number of organs, including the [removed: lungs.][added: lungs, where mucus builds up, causing]
[removed: In particular, mucus builds up and clogs the airways in the lungs, causing] chronic lung infections and progressive lung damage.
[removed: Our CFTR regimens target the underlying cause of disease and have been shown to improve CFTR protein function in people with CF, and as] such have been shown to provide transformative benefit for people living with CF.
Our CF medicines are [removed: used by patients in over 60 countries, and TRIKAFTA/KAFTRIO is approved and] reimbursed or accessible in more than [removed: 50 of these countries.][added: 60 countries across six continents.]
[removed: ALYFTREK is our next-in-class triple combination, which has the benefit of a once-daily dosing regimen and demonstrated non-inferiority] [added: inferiority] to TRIKAFTA in ppFEV1, a measure of lung function, and an improvement in sweat chloride levels as compared [removed: to TRIKAFTA.]
people with serious diseases, with a focus on specialty markets.
We have approved medicines for cystic fibrosis (“CF”),
sickle cell disease (“SCD”), transfusion dependent beta thalassemia (“TDT”), and acute pain, and we continue to serially
innovate and advance next-generation clinical and research programs in these areas.
Our mid- and late-stage clinical pipeline
includes programs across a range of modalities in additional serious diseases, including IgA nephropathy, APOL1-mediated
disease, and myotonic dystrophy type 1.
We are developing povetacicept, a dual inhibitor of the B cell activating factor (“BAFF”) and a
proliferation-inducing ligand (“APRIL”) pathways, as a potentially best-in-class approach to treat IgA nephropathy
(“IgAN”), a serious, progressive, life-threatening kidney disease that often progresses to end-stage renal disease.
We
completed enrollment in the IgAN Phase 3 clinical trial and submitted the first module of the rolling Biologics
Licensing Application (“BLA”) for povetacicept in IgAN in the fourth quarter of 2025.
We expect to complete the
submission for potential accelerated approval in the U.S. in the first half of 2026.
first-in-class treatment for APOL1-mediated kidney disease (“AMKD”).
We have completed the enrollment of the
interim analysis cohort of the Phase 2/3 clinical trial and will conduct the pre-planned interim analysis once this
cohort reaches 48 weeks of treatment.
We expect to share data from the interim analysis in late 2026 or early 2027.
*•Peripheral Neuropathic Pain.* We are developing suzetrigine, a selective non-opioid NaV1.8 pain signal inhibitor,
for diabetic peripheral neuropathy (“DPN”), a common form of peripheral neuropathic pain.
We are evaluating
suzetrigine for the treatment of DPN in two Phase 3 clinical trials.
We expect to complete enrollment in both Phase
3 clinical trials by the end of 2026.
development for the treatment of type 1 diabetes (“T1D”).
We have completed enrollment in the Phase 1/2/3 clinical
trial of zimislecel in people with T1D.
We have temporarily postponed completion of the dosing in this clinical trial,
pending an ongoing internal manufacturing analysis.
*•Primary Membranous Nephropathy.* We are also developing povetacicept to treat primary membranous nephropathy
(“pMN”), a rare and serious autoimmune glomerular disease that can lead to kidney damage and renal failure, and
which has no treatments specifically approved for this condition.
We continue to enroll and dose patients in the
adaptive Phase 2/3 pivotal trial in people with pMN.
and to initiate the Phase 3 portion in mid-2026.
Our core strategy is to discover, develop, and commercialize innovative medicines by combining transformative
We
registration and approval, and product candidates that hold the potential for transformative patient benefit.
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.
In December 2024, the U.S. Food and Drug Administration (the “FDA”) approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), our fifth medicine for people with CF.
In addition to ALYFTREK, our marketed medicines that treat people with CF are TRIKAFTA/KAFTRIO (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO/SYMKEVI (tezacaftor/ivacaftor and ivacaftor), ORKAMBI (lumacaftor/ivacaftor) and KALYDECO (ivacaftor).
Through approval 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.
We are evaluating our current 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 cystic fibrosis transmembrane conductance regulator (“CFTR”) gene that is responsive to our CFTR modulators.
In December 2024, the FDA approved the expanded use of TRIKAFTA for treatment of people with CF.
With this approval, 94 additional non-F508del CFTR mutations have been added to the TRIKAFTA label.
We are evaluating VX-522, an investigational messenger ribonucleic acid (“mRNA”) therapeutic that we are developing in collaboration with Moderna, Inc. (“Moderna”) in a Phase 1/2 clinical trial in people with CF.
The multiple ascending dose portion of the clinical trial is ongoing, and we expect to share data in the first half of 2025.
In addition, we are continuing our research and development of additional CFTR modulators, with the aim of developing best-in-class medicines that can help more patients achieve normal levels of CFTR function, and we are investigating additional potential treatments for people with CF who do not make full-length CFTR protein and cannot benefit from CFTR modulators.
In SCD and TDT, our goal is to eliminate vaso-occlusive crises (“VOCs”) (as well as vaso-occlusive organ damage) and transfusion dependence, respectively.
Our marketed therapy is CASGEVY (exagamglogene autotemcel), an ex-vivo, non-viral CRISPR/Cas9 gene-edited cell therapy, which has been approved in the United States (“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”), Canada and Switzerland for treatment of people 12 years of age and older with SCD or TDT.
We are evaluating CASGEVY as a treatment for children 5 to 11 years of age with SCD or TDT in global Phase 3 clinical trials.
We are progressing preclinical assets for gentler conditioning for CASGEVY, which could broaden the eligible patient population, and investigating small molecules for the potential treatment of SCD and TDT.
We have begun our commercial launch of JOURNAVX in eligible adults in the U.S. 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.
We are enrolling and dosing patients in two Phase 2 clinical trials evaluating VX-993, a next-generation selective NaV1.8 pain signal inhibitor, for the treatment of acute pain and for the treatment of diabetic peripheral neuropathy.
In December 2024, we announced results from a Phase 2 clinical trial evaluating suzetrigine in people with lumbosacral radiculopathy (“LSR”).
Treatment with suzetrigine
demonstrated a statistically significant and clinically meaningful within-group reduction in pain and we plan to advance to pivotal development in LSR, pending discussions with regulators.
We are developing povetacicept, a dual inhibitor of the B cell activating factor (“BAFF”) and a proliferation-inducing ligand (“APRIL”) pathways, as a potentially best-in-class approach to treat IgA nephropathy (“IgAN”), a serious progressive, autoimmune kidney disease that can lead to end-stage renal disease.
Our second clinical program in T1D, VX-264, in which zimislecel is encapsulated in an immunoprotective device, is ongoing.
We are also pursuing alternative approaches to immunosuppression that could be used with zimislecel, as well as hypoimmune cells.
- *Myotonic Dystrophy Type 1.* We are exploring multiple approaches to address the underlying causal biology for myotonic dystrophy type 1 (“DM1”), including small molecules.
We completed the single ascending dose portion of the global Phase 1/2 clinical trial evaluating VX-670, an oligonucleotide-based approach that we have in-licensed from Entrada Therapeutics, Inc. (“Entrada”).
We are enrolling and dosing the multiple ascending dose portion of the trial, which will evaluate the safety and efficacy of VX-670.
We are nearing completion of a Phase 1 clinical trial in healthy volunteers evaluating VX-407, our first-in-class small molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (“ADPKD”) in people with a subset of variants in the PKD1 gene.
We expect to advance VX-407 into a Phase 2 proof-of-concept study in people with ADPKD in 2025.
- In addition to the programs listed above, we have additional research programs aimed at diseases that fit our research and development strategy and follow-on programs in our existing disease areas in accord with our serial innovation approach.
We aim to rapidly follow our first-in-class therapies that achieve proof-of-concept with potential best-in-class candidates.
Our CF medicines are the exemplar of this strategy, as we continue to reach more people with CF than ever before through approvals of new medicines, approvals in new geographies, label expansions, including for younger patients, and expanded reimbursement.
In addition, we have diversified our business through the approvals for CASGEVY for the treatment of SCD and TDT and through the approval for JOURNAVX for the treatment of acute pain.
Within our clinical pipeline, we have rapidly progressed multiple programs into pivotal development during the last year.
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|  | | | 2015 | | | 1 year of age and older | | |
|  | | | 2012 | | | 1 month of age and older | | |
Our CF medicines are collectively being used by nearly three quarters of the approximately 94,000 people with CF in the U.S., Europe, Australia, and Canada.
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.
An excerpt. Shown here: 40 of 392 rewritten, 40 of 1,001 added and 40 of 445 removed. The counts are complete. For every sentence, read Item 1. BUSINESS in the FY2025 filing and the FY2024 filing.
Item 3. LEGAL PROCEEDINGS
1 rewritten, 1 added, 0 removed, 0 unchanged
[removed: We are] not currently subject to any material legal proceedings.
Other than as described in Note P, “Commitments and Contingencies,” to our consolidated financial statements, we are
Cover and table of contents
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[removed: FORM 10-K][added: FORM 10-K]
[removed: ☒ ANNUAL] [added: ☒ANNUAL] REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year [removed: Ended December] [added: Ended December] 31, [removed: 2024][added: 2025]
[removed: ☐ TRANSITION] [added: ☐TRANSITION] REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission file [removed: number 000-19319][added: number 000-19319]
50 Northern [removed: Avenue, Boston, Massachusetts][added: Avenue, Boston, Massachusetts]
Registrant’s telephone number, including area code [removed: (617) 341-6100][added: (617) 341-6100]
| Title of Each Class | | [removed: | | | |] Trading Symbol | [removed: | |] Name of Each Exchange on Which Registered | | [removed: | | | |]
| Common Stock, $0.01 Par Value Per Share | | [removed: | | | |] VRTX | [removed: | |] The Nasdaq Global Select Market | | [removed: | | | |]
Yes ☒ [removed: No ☐]
[removed: Indicate by check mark whether] the [removed: registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the] preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for [removed: the past 90 days.]
[removed: Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of] Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging [removed: growth company.]
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 [removed: of the Exchange Act (Check one):]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or [removed: revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.]
[removed: Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over] financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit [removed: report.]
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing [removed: reflect the correction of an error to previously issued financial statements.]
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any [removed: of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b).]
The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant based on the closing price on June [removed: 28, 2024] [added: 30, 2025] (the last business [removed: day of the registrant’s most recently completed second fiscal quarter of 2024) was $121.8 billion.]
As of February [removed: 7, 2025,] [added: 6, 2026,] the registrant had [removed: 256,789,869] [added: 254,034,190] shares of common stock outstanding.
Portions of the definitive proxy statement for the [removed: 2025] [added: 2026] Annual Meeting of Shareholders, which we expect to hold on May [removed: 14, 2025,] [added: 13, 2026,] are incorporated by [removed: reference into Part III of this Annual Report on Form 10-K.]
| [Item [removed: 1.](#ie9f459f6387e4b038fe2ec4558eff10a_13) | | | [Business](#ie9f459f6387e4b038fe2ec4558eff10a_13) | | | [1](#ie9f459f6387e4b038fe2ec4558eff10a_13)] [added: 1.](#ib44b4620d6d245e0bae824a83c255a23_13)] | [added: [Business](#ib44b4620d6d245e0bae824a83c255a23_13)] | [added: [1](#ib44b4620d6d245e0bae824a83c255a23_13)] |
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Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
No ☐
growth company.
of the Exchange Act (Check one):
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over
report.
reflect the correction of an error to previously issued financial statements.
of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b).
day of the registrant’s most recently completed second fiscal quarter of 2025) was $113.4 billion.
reference into Part III of this Annual Report on Form 10-K.
| | | |
| --- | --- | --- |
| [PART I](#ib44b4620d6d245e0bae824a83c255a23_10) | | |
| [PART III](#ib44b4620d6d245e0bae824a83c255a23_154) | | |
| [PART IV](#ib44b4620d6d245e0bae824a83c255a23_172) | | |
| | [Signatures](#ib44b4620d6d245e0bae824a83c255a23_181) | [70](#ib44b4620d6d245e0bae824a83c255a23_181) |
Incorporated, a Massachusetts corporation, and its subsidiaries.
“VERTEX®,” “KALYDECO®,” “ORKAMBI®,” “SYMDEKO®,” “SYMKEVI®,” “TRIKAFTA®,” “KAFTRIO®,”
Other brands, names and
indications on the approved label.
Otherwise, we refer to our product candidates by their scientific (or generic) name or VX
developmental designation.
Words such as “anticipates,” “may,”
similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements
contain these identifying words.
Please refer to “Special Note Regarding Forward-Looking Statements” set forth in Part I,
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| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| [PART I](#ie9f459f6387e4b038fe2ec4558eff10a_10) | | | | | | | | |
| [PART III](#ie9f459f6387e4b038fe2ec4558eff10a_151) | | | | | | | | |
| [PART IV](#ie9f459f6387e4b038fe2ec4558eff10a_169) | | | | | | | | |
| | | | [Signatures](#ie9f459f6387e4b038fe2ec4558eff10a_178) | | | [99](#ie9f459f6387e4b038fe2ec4558eff10a_178) | | |
Otherwise, including in discussions of our cystic fibrosis, sickle cell disease, beta thalassemia, and pain development programs, we refer to our product candidates by their scientific (or generic) name or VX developmental designation.
An excerpt. Shown here: 40 of 52 rewritten, all 31 added and all 9 removed. The counts are complete. For every sentence, read Cover and table of contents in the FY2025 filing and the FY2024 filing.
Item 1B. UNRESOLVED STAFF COMMENTS
1 rewritten, 2 added, 0 removed, 0 unchanged
We did not receive any written comments from the Securities and Exchange Commission prior to the date 180 days [removed: before the end of the fiscal year ended December 31, 2024 regarding our filings under the Securities Exchange Act of 1934, as amended, that have not been resolved.]
before the end of the fiscal year ended December 31, 2025 regarding our filings under the Securities Exchange Act of 1934,
as amended, that have not been resolved.
Item 1C. CYBERSECURITY
21 rewritten, 53 added, 4 removed, 2 unchanged
[removed: We recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to] maintain the security, confidentiality, integrity, and availability of our business systems and confidential information, [removed: including personal information and intellectual property.]
[removed: This program includes processes to oversee and identify material risks from] cybersecurity threats associated with our use of third-party service providers.
[removed: We also engage a range of third-party experts in] connection with various development, implementation, and maintenance activities related to our cybersecurity program, [removed: including audit and compliance, threat hunting, monitoring, and end-user support.]
Our cybersecurity program is integrated into our overall risk management systems, including our annual enterprise risk [removed: management program, internal audit program, business continuity and crisis management programs, third-party risk management program, insurance risk management program, and employee compliance programs.]
[removed: As part of our overall risk] management program, we maintain a global insurance portfolio with comprehensive cyber coverage.
[removed: Our Chief Information] Security Officer (“CISO”) and the Information Security function advises, consults with, or provides input to each of these [removed: programs to ensure that material risks from cybersecurity threats are appropriately assessed, identified, and managed.]
As of the date of this report, there have been no cybersecurity threats that have materially affected or are reasonably [removed: likely to materially affect our business, operations, or financial condition.]
[removed: Similar to other companies, we have experienced] cybersecurity incidents, including temporary service interruptions of third-party suppliers.
[removed: As of the date of this report,] however, known cybersecurity incidents, individually or in aggregate, have not had a material impact on our company.
[removed: Over] the last three years, net expenses incurred from any information security breaches, including any penalties and settlements, [removed: are not material relative to our total revenue.]
For additional discussion on cybersecurity risks we face, see [removed: Item 1.A Risk Factors — *A breakdown or breach of our information technology systems could subject us to liability or interrupt the operation of our business*.][added: *Item 1.A, Risk*]
While our board of directors has oversight responsibility for risk management generally, the Audit and Finance [removed: Committee (“Audit Committee”) is specifically responsible for overseeing our cybersecurity risk management program to ensure that cybersecurity risks are identified, assessed, managed, and monitored.]
[removed: Our CISO provides quarterly updates to the] Audit Committee in this regard, and covers the state of our cybersecurity program, supported by key performance indicators [removed: across the range of cybersecurity functions related to risk management and governance, identity and information asset protection, core security and endpoint security, and cyber threat operations.]
[removed: These updates include descriptions of] cybersecurity incidents of interest, including those associated with our third-party service providers; the board will be [removed: informed promptly of material risks from cybersecurity threats.]
We strive to create a culture of cybersecurity resilience and awareness and believe that cybersecurity is the responsibility [removed: of every employee and contractor.]
[removed: Our CISO supported the U.S. President's National Security Telecommunications Advisory] Committee for more than 20 years, is a member of the Massachusetts Cybersecurity Strategy Council, and previously served [removed: as Chair of the Kogod Cybersecurity Governance Center at American University.]
[removed: He also served on the Rhode Island] Homeland Security Advisory Board and was a member of various commercial cyber product councils.
[removed: Our CISO oversees a team of skilled cybersecurity professionals who have Certified Information Systems Security] Professional [removed: (“CISSP”)] credentials, Global Information Assurance Certification from the SANS Institute, and other security and network [removed: certifications.]
[removed: The cybersecurity team monitors and evaluates our cybersecurity posture and performance on an ongoing] basis, including through regular vulnerability scans, penetration tests, and threat intelligence feeds.
[removed: The cybersecurity team] uses various tools and methodologies to manage cybersecurity risk that are tested on a regular cadence, and assesses and [removed: evaluates cybersecurity incidents, escalating certain cybersecurity incidents to the CISO according to protocol.]
[removed: The CISO is continually informed regarding the performance of the cybersecurity program, as well as the latest developments in] cybersecurity, including potential threats and innovative risk management techniques aligned with industry standards.
We recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to
including personal information and intellectual property.
Our cybersecurity program includes systems and processes for
assessing, identifying and managing material risks from cybersecurity threats and include maintenance and monitoring of
information security policies aligned with global regulatory controls and aligned with National Institute of Standards and
Technology Cybersecurity Framework and System and Organization Controls 2.
The program includes user and employee
awareness of cyber policies and practices; information systems configuration management; third-party risk management
systems; identity and information asset protection; infrastructure security systems; and cyber threat operations with
continuous monitoring and threat hunting.
This program also includes processes to oversee and identify material risks from
We engage a range of third-party experts in
including audit and compliance, threat hunting, monitoring, and end-user support.
management program, internal audit program, business continuity and crisis management programs, third-party risk
management program, insurance risk management program, and employee compliance programs.
As part of our overall risk
Our Chief Information
programs to ensure that material risks from cybersecurity threats are appropriately assessed, identified, and managed.
likely to materially affect our business, operations, or financial condition.
Similar to other companies, we have experienced
As of the date of this report,
Over
are not material relative to our total revenue.
*Factors – “A breakdown or breach of our information technology systems,* *or unauthorized access to confidential*
*information could adversely affect our business.”* of this Annual Report on Form 10-K
Committee (“Audit Committee”) is specifically responsible for overseeing our cybersecurity risk management program to
ensure that cybersecurity risks are identified, assessed, managed, and monitored.
Our CISO provides quarterly updates to the
across the range of cybersecurity functions related to risk management and governance, identity and information asset
protection, core security and endpoint security, and cyber threat operations.
These updates include descriptions of
informed promptly of material risks from cybersecurity threats.
of every employee and contractor.
At the same time, primary responsibility for assessing, monitoring, and managing our
cybersecurity risks lies with our CISO.
Our CISO has more than 35 years of experience in security and information systems
and spent 25 years with Raytheon Technologies, most recently as Chief Technology Officer of Cybersecurity, Special
Missions, Training & Services.
Our CISO supported the U.S. President's National Security Telecommunications Advisory
as Chair of the Kogod Cybersecurity Governance Center at American University.
Our cybersecurity program includes systems and processes for assessing, identifying and managing material risks from cybersecurity threats and include maintenance and monitoring of information security policies aligned with global regulatory controls and aligned with National Institute of Standards and Technology Cybersecurity Framework; user and employee awareness of cyber policies and practices; information systems configuration management; third-party risk management systems; identity and information asset protection; infrastructure security systems; and cyber threat operations with continuous monitoring and threat hunting.
At the same time, primary responsibility for assessing, monitoring, and managing our cybersecurity risks lies with our CISO, Michael Daly, who has more than 35 years of experience in security and information systems and spent 25 years with Raytheon Technologies, most recently as Chief Technology Officer of Cybersecurity, Special Missions, Training & Services.
The CISO reports to our Chief Scientific Officer (“CSO”).
Our CSO is an executive officer and leads internal research and external innovation, corporate data strategy, technology and data sciences, and reports directly to our CEO.
An excerpt. Shown here: all 21 rewritten, 40 of 53 added and all 4 removed. The counts are complete. For every sentence, read Item 1C. CYBERSECURITY in the FY2025 filing and the FY2024 filing.
Item 2. PROPERTIES
4 rewritten, 10 added, 1 removed, 2 unchanged
[removed: We have the option to extend the] term of the leases for up to two additional ten-year periods.
In addition to our corporate headquarters, we lease an aggregate of approximately [removed: 850,000] [added: 865,000] square feet of space globally.
This space includes logistical, laboratory, commercial and manufacturing operations, as well as laboratory and office space to [removed: support our research and development organizations.]
We also own approximately 213,000 square feet at our continuous [removed: manufacturing facility in Massachusetts.]
We lease approximately 1.1 million square feet of office and laboratory space at our corporate headquarters in Boston,
Massachusetts in two buildings pursuant to two leases that we entered into in May 2011 and amended in August 2024 to,
among other terms, extend the lease termination dates from December 2028 to June 2044.
We have the option to extend the
support our research and development organizations.
manufacturing facility in Massachusetts.
Additionally, we are constructing the second building of our Leiden Campus in
Massachusetts (“Leiden II”), which will include approximately 348,000 square feet of office and laboratory space.
We expect
Leiden II to be operational in late 2026.
We lease approximately 1.1 million square feet of office and laboratory space at our corporate headquarters in Boston, Massachusetts in two buildings pursuant to two leases that we entered into in May 2011 and amended in August 2024 to, among other terms, extend the lease termination dates from December 2028 to June 2044.
Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
10 rewritten, 14 added, 6 removed, 6 unchanged
As of February [removed: 7, 2025,] [added: 6, 2026,] there were [removed: 101] [added: 94] holders of record of our common stock.
[removed: Our performance graph includes the NASDAQ Biotechnology Index, which we believe is a comparable index consisting] of companies with similar industry classifications, and which we plan to use in our future performance graphs.
][added: cum return.jpg](https://www.sec.gov/Archives/edgar/data/875320/000087532026000056/vrtx-20251231_g11.jpg)]
We have never paid any cash dividends on our common stock, and we do not anticipate paying any in the foreseeable [removed: future.]
[removed: In February 2023, our Board of Directors approved a share repurchase program (the “Share Repurchase Program”)] pursuant to which we are authorized to repurchase up to [removed: $3.0] [added: $4.0] billion of our common stock.
[removed: Our Share Repurchase] Program does not have an expiration date and can be discontinued at any time.
The table set forth below shows repurchases of securities by us during the three months ended December 31, [removed: 2024] [added: 2025] under [removed: our Share Repurchase Program.]
| Period | [removed: | | Total Number of Shares Purchased | | | | | | Average Price Paid per Share | |] [added: Total Number of Shares Purchased] | | [added: Average Price Paid per Share] | | Total Number of [removed: Shares Purchased] [added: Shares Purchased] as Part of Publicly [removed: Announced Programs] [added: Announced Programs] (1) | | [removed: | | | |] Approximate Dollar [removed: Value of] [added: Value of] Shares that May Yet Be Purchased Under [removed: the Programs] [added: the Programs] (1) | [removed: | |]
(1)Under our [added: 2025] Share Repurchase Program, we are authorized to purchase shares from time to time through open market or privately [removed: negotiated transactions.]
Such purchases may be made pursuant to Rule 10b5-1 plans or other means as determined by our management [removed: and in accordance with the requirements of the Securities and Exchange Commission.]
ISSUER PURCHASES OF EQUITY SECURITIES
Our performance graph includes the NASDAQ Biotechnology Index, which we believe is a comparable index consisting
future.
In May 2025, our Board of Directors approved a share repurchase program (our “2025 Share Repurchase Program”),
The 2025 Share Repurchase
our 2025 Share Repurchase Program.
| | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Oct. 1, 2025 to Oct. 31, 2025 | 256,788 | | $409.11 | | 256,788 | | $3,381,462,793 |
| Nov. 1, 2025 to Nov. 30, 2025 | — | | $— | | — | | $3,381,462,793 |
| Dec. 1, 2025 to Dec. 31, 2025 | — | | $— | | — | | $3,381,462,793 |
| Total | 256,788 | | $409.11 | | 256,788 | | $3,381,462,793 |
negotiated transactions.
and in accordance with the requirements of the Securities and Exchange Commission.
| | | | | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Oct. 1, 2024 to Oct. 31, 2024 | | | 230,000 | | | | | | $ | 472.77 | | | | | 230,000 | | | | | | $ | 1,699,865,374 | |
| Nov. 1, 2024 to Nov. 30, 2024 | | | 221,000 | | | | | | $ | 471.15 | | | | | 221,000 | | | | | | $ | 1,595,740,301 | |
| Dec. 1, 2024 to Dec. 31, 2024 | | | 510,129 | | | | | | $ | 420.46 | | | | | 510,129 | | | | | | $ | 1,381,251,940 | |
| Total | | | 961,129 | | | | | | $ | 444.63 | | | | | 961,129 | | | | | | $ | 1,381,251,940 | |
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
1 rewritten, 0 added, 0 removed, 0 unchanged
The information required by this Item 8 is contained on pages F-1 through [removed: F-49] [added: F-[49](#i27e710948553486a88377c39cbcabb3a_4199)] of this Annual Report on Form 10-K.
Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
0 rewritten, 1 added, 0 removed, 1 unchanged
FINANCIAL DISCLOSURE
Item 9A. CONTROLS AND PROCEDURES
22 rewritten, 56 added, 4 removed, 11 unchanged
[removed: In designing and evaluating the disclosure controls and procedures, management recognized that] any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving [removed: the desired control objectives, and management necessarily was required to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures.]
(2) Management’s Annual Report on Internal Control Over Financial Reporting. Management is responsible for [removed: establishing and maintaining adequate internal control over financial reporting.]
[removed: Our internal control] over financial reporting include those policies and procedures that:
- pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and [removed: dispositions of our assets;]
[removed: - provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial] statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are [removed: being made only in accordance with authorizations of management and our directors; and]
[removed: - provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or] disposition of our assets that could have a material effect on the financial statements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become [removed: inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.]
Management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2024.][added: 2025.]
[removed: In] making this assessment, we used the criteria set forth in the *Internal Control—Integrated Framework (2013)* issued by the [removed: Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).]
[removed: Based on our assessment, management has] concluded that, as of December 31, [removed: 2024,] [added: 2025,] our internal control over financial reporting is effective based on those criteria.
Our independent registered public accounting firm, Ernst & Young LLP, issued an attestation report on our internal [removed: control over financial reporting.]
[removed: (3) Changes in Internal Controls. During the quarter ended December 31, 2024, there were no changes in our internal] control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over [removed: financial reporting.]
[removed: We have audited Vertex Pharmaceuticals Incorporated’s internal control over financial reporting as of December 31, 2024,] based on criteria established in Internal [removed: Control–Integrated] [added: Control*—*Integrated] Framework issued by the Committee of Sponsoring [removed: Organizations of the Treadway Commission (2013 framework) (the COSO criteria).]
[removed: In our opinion, Vertex Pharmaceuticals] Incorporated (the Company) maintained, in all material respects, effective internal control over financial reporting as of [removed: December 31, 2024, based on the COSO criteria.]
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) [removed: (PCAOB), the 2024 consolidated financial statements of the Company and our report dated February 13, 2025, expressed an unqualified opinion thereon.]
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its [removed: assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting.]
[removed: Our responsibility is to express an opinion on the Company’s] internal control over financial reporting based on our audit.
[removed: We] are [removed: a public accounting firm registered with the PCAOB and are] required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the [removed: applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.]
[removed: Those standards require that we plan and perform] the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in [removed: all material respects.]
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material [removed: weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.]
We believe that our audit provides a [removed: reasonable basis for our opinion.]
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the [removed: reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.]
(1) Evaluation of Disclosure Controls and Procedures. Our chief executive officer and chief financial officer, after
evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e)
promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period
covered by this Annual Report on Form 10-K, have concluded that, based on such evaluation, our disclosure controls and
procedures were effective.
In designing and evaluating the disclosure controls and procedures, management recognized that
the desired control objectives, and management necessarily was required to apply our judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
establishing and maintaining adequate internal control over financial reporting.
Internal control over financial reporting is
defined in Rule 13a-15(f) and Rule 15d-15(f) promulgated under the Exchange Act, as a process designed by, or under the
supervision of, our principal executive and principal financial officers and effected by our board of directors, management
and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles.
Our internal control
dispositions of our assets;
- provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
being made only in accordance with authorizations of management and our directors; and
- provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
In
Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).
Based on our assessment, management has
control over financial reporting.
(3) Changes in Internal Controls. During the quarter ended December 31, 2025, there were no changes in our internal
financial reporting.
We have audited Vertex Pharmaceuticals Incorporated’s internal control over financial reporting as of December 31, 2025,
Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
In our opinion, Vertex Pharmaceuticals
December 31, 2025, based on the COSO criteria.
(PCAOB), the 2025 consolidated financial statements of the Company and our report dated February 13, 2026 expressed an
unqualified opinion thereon.
assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s
Annual Report on Internal Control Over Financial Reporting.
Our responsibility is to express an opinion on the Company’s
We are a public accounting firm registered with the PCAOB and
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
Those standards require that we plan and perform
all material respects.
(1) Evaluation of Disclosure Controls and Procedures. Our chief executive officer and chief financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this Annual Report on Form 10-K, have concluded that, based on such evaluation, our disclosure controls and procedures were effective.
Internal control over financial reporting is defined in Rule 13a-15(f) and Rule 15d-15(f) promulgated under the Exchange Act, as a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
February 13, 2025
An excerpt. Shown here: all 22 rewritten, 40 of 56 added and all 4 removed. The counts are complete. For every sentence, read Item 9A. CONTROLS AND PROCEDURES in the FY2025 filing and the FY2024 filing.
Item 9B. OTHER INFORMATION
7 rewritten, 19 added, 5 removed, 0 unchanged
*Rule [removed: 10b5-1 Trading] [added: 10b5-1* *Trading] Plans*
[removed: Our policy governing transactions in our securities by our directors, officers, and employees permits our officers,] directors and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act.
[removed: The following table] describes the written plans for the sale of our securities adopted by our directors and officers (as defined in Rule 16a-1(f) [removed: under the Exchange Act) during the fourth quarter of 2024, each of which is intended to satisfy the affirmative defense conditions of Rule 10b5-1 (each, a “Trading Plan”).]
Other than as described in the table below, none of our directors or [removed: officers adopted, modified or terminated a Trading Plan in the fourth quarter of 2024.]
| Name and Title | | [removed: | | | |] Date of [removed: Adoption of] [added: Adoption of] Trading Plan | | [removed: | | | |] Scheduled [removed: Expiration Date] [added: Expiration Date] of Trading [removed: Plan (1) | | | |] [added: Plan(1)] | | Maximum [removed: Shares Subject] [added: Shares Subject] to [removed: Trading Plan | |] [added: Trading Plan] |
| (1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan. | | | | | | | [removed: | | | | | | | | | | | | | |]
A copy of the [removed: 2025] Restated [removed: By-Laws] [added: Articles of Organization] is [removed: attached] [added: filed] as Exhibit [removed: 3.2] [added: 3.1] to this Annual Report on Form 10-K and is [removed: incorporated by reference herein.]
Our policy governing transactions in our securities by our directors, officers, and employees permits our officers,
The following table
under the Exchange Act) during the fourth quarter of 2025, each of which is intended to satisfy the affirmative defense
conditions of Rule 10b5-1 (each, a “Trading Plan”).
officers adopted, modified or terminated a Trading Plan in the fourth quarter of 2025.
| | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Reshma Kewalramani *Chief Executive Officer and President* | | 11/17/2025 | | 11/16/2026 | | 40,000 |
| Amit Sachdev *EVP, Chief Patient and External Affairs Officer* | | 11/18/2025 | | 10/30/2026 | | 70,498(2) |
| Carmen Bozic *EVP, Global Medicines Development and* *Medical Affairs, Chief Medical Officer* | | 11/20/2025 | | 11/02/2026 | | 34,733(2) |
| Duncan McKechnie *EVP, Chief Commercial Officer* | | 11/25/2025 | | 11/13/2026 | | 17,367(2) |
| (2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable. | | | | | | |
*2026 Restated Articles of Organization*
On February 12, 2026, the Company filed Restated Articles of Organization with the Secretary of the Commonwealth of
Massachusetts to consolidate its Articles of Organization and all prior amendments and to remove references to the Series A
Junior Participating Preferred Stock, which is no longer outstanding.
The restatement was effected for clarity only and did not
result in any changes to the rights of holders of the Company’s common stock.
incorporated herein by reference.
| | | | | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ourania "Nia" Tatsis *EVP, Chief Regulatory and Quality Officer* | | | | | | 11/22/2024 | | | | | | 10/31/2025 | | | | | | 11,270 | | |
*2025 Restated Bylaws*
On February 11, 2025, our Board of Directors approved our Amended and Restated By-Laws (the “2025 Restated Bylaws”) to reduce the percentage of our capital stock required to call a special meeting of shareholders from 40% to 25%.
Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
1 rewritten, 1 added, 0 removed, 2 unchanged
Portions of our definitive Proxy Statement for the [removed: 2025] [added: 2026] Annual Meeting of Shareholders [removed: (“2025] [added: (“2026] Proxy Statement”) are [removed: incorporated by reference into this Part III of our Annual Report on Form 10-K.]
incorporated by reference into this Part III of our Annual Report on Form 10-K.
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
3 rewritten, 8 added, 1 removed, 0 unchanged
The information regarding directors required by this Item 10 will be included in our [removed: 2025] [added: 2026] Proxy Statement and is [removed: incorporated herein by reference.]
We have adopted insider trading policies and procedures governing the purchase, sale and/or other dispositions of our [removed: securities by directors, officers and employees, or Vertex itself, that are reasonably designed to promote compliance with insider trading laws, rules and regulations and any listing standards applicable to us.]
[removed: A copy of our Insider Trading Policy has been] filed as Exhibit 19.1 to this Annual Report on Form 10-K.
incorporated herein by reference.
We expect this information to be provided under “Election of Directors,” “Corporate
Governance and Risk Management,” “Shareholder Proposals for the 2027 Annual Meeting and Nominations for Director,”
“Delinquent Section 16(a) Reports” and “Code of Conduct.” The information regarding executive officers required by this
Item 10 is included in Part I of this Annual Report on Form 10-K.
securities by directors, officers and employees, or Vertex itself, that are reasonably designed to promote compliance with
insider trading laws, rules and regulations and any listing standards applicable to us.
A copy of our Insider Trading Policy is
We expect this information to be provided under “Election of Directors,” “Corporate Governance and Risk Management,” “Shareholder Proposals for the 2026 Annual Meeting and Nominations for Director,” “Delinquent Section 16(a) Reports” and “Code of Conduct.” The information regarding executive officers required by this Item 10 is included in Part I of this Annual Report on Form 10-K.
Item 11. EXECUTIVE COMPENSATION
2 rewritten, 3 added, 0 removed, 0 unchanged
The information required by this Item 11 will be included in the [removed: 2025] [added: 2026] Proxy Statement and is incorporated herein by [removed: reference.]
We expect this information to be provided under “Compensation Committee Interlocks and Insider Participation,” [removed: “Compensation Discussion and Analysis,” “Compensation and Equity Tables,” “Director Compensation,” “Management Development and Compensation Committee Report” and/or “Corporate Governance and Risk Management.”]
reference.
“Compensation Discussion and Analysis,” “Compensation and Equity Tables,” “Director Compensation,” “Management
Development and Compensation Committee Report” and/or “Corporate Governance and Risk Management.”
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
2 rewritten, 3 added, 0 removed, 0 unchanged
The information required by this Item 12 will be included in the [removed: 2025] [added: 2026] Proxy Statement and is incorporated herein by [removed: reference.]
We expect this information to be provided under “Security Ownership of Certain Beneficial Owners and [removed: Management” and “Equity Compensation Plan Information.”]
RELATED STOCKHOLDER MATTERS
reference.
Management” and “Equity Compensation Plan Information.”
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
2 rewritten, 2 added, 0 removed, 0 unchanged
The information required by this Item 13 will be included in the [removed: 2025] [added: 2026] Proxy Statement and is incorporated herein by [removed: reference.]
We expect this information to be provided under “Election of Directors,” “Corporate Governance and Risk [removed: Management,” and “Audit and Finance Committee.”]
reference.
Management,” and “Audit and Finance Committee.”
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
2 rewritten, 2 added, 0 removed, 1 unchanged
The information required by this Item 14 will be included in the [removed: 2025] [added: 2026] Proxy Statement and is incorporated herein by [removed: reference.]
We expect this information to be provided under “Ratification of the Appointment of Independent Registered [removed: Public Accounting Firm.”]
reference.
Public Accounting Firm.”
Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
80 rewritten, 22 added, 8 removed, 4 unchanged
(a)(1) The Financial Statements required to be filed by Items 8 and 15(c) of Form 10-K, and filed herewith, are as [removed: follows:]
| | [removed: | |] Page Number [removed: in this] [added: in this] Form 10-K | [removed: | |]
| Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) [removed: | | | F-[1](#ie9f459f6387e4b038fe2ec4558eff10a_181) |] [added: .......................................................] | [added: F-[1](#ib44b4620d6d245e0bae824a83c255a23_184)] |
| Notes to Consolidated Financial Statements [removed: | | | F-[9](#ie9f459f6387e4b038fe2ec4558eff10a_199) |] [added: ........................................................................................................................] | [added: F-[8](#ib44b4620d6d245e0bae824a83c255a23_202)] |
(a)(2) Financial Statement Schedules have been omitted because they are either not applicable or the required [removed: information is included in the consolidated financial statements or notes thereto listed in (a)(1) above.]
| [removed: Exhibit Number | |] [added: Exhibit Number] | Exhibit Description | [removed: | | Filed with this report | |] [added: Filed with this report] | Incorporated [removed: by Reference herein from—Form or Schedule | |] [added: by Reference herein from—Form or Schedule] | Filing [removed: Date/ Period] [added: Date/ Period] Covered | [removed: | |] SEC [removed: File/Reg. Number | |] [added: File/ Reg. Number] |
| Governance Documents | | | | | | [removed: | | | | | | | | | | | |]
| 3.1 | [removed: | |] [Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, [removed: as amended.](https://www.sec.gov/Archives/edgar/data/875320/000087532018000022/a2018q210-qexhibit31.htm) | | | | | | 10-Q (Exhibit 3.1) | | | July 26, 2018 |] [added: as](https://www.sec.gov/Archives/edgar/data/875320/000087532026000056/a10k_2025-exhibit31.htm) [amended.](https://www.sec.gov/Archives/edgar/data/875320/000087532026000056/a10k_2025-exhibit31.htm)] | [added: X] | [removed: 000-19319] | | |
| 3.2 | [removed: | |] [Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated.](https://www.sec.gov/Archives/edgar/data/875320/000087532025000053/a10k_2024-exhibit32.htm) | | [removed: | X | | | | | | | | |] [added: 10-K (Exhibit 3.2)] | [added: February 13, 2025] | [added: 000-19319] |
| Stock Certificate | | | | | | [removed: | | | | | | | | | | | |]
| 4.1 | [removed: | |] [Specimen Stock Certificate.](https://www.sec.gov/Archives/edgar/data/875320/000087532018000009/a10k2017exhibit41.htm) | | [removed: | | | |] 10-K (Exhibit 4.1) | [removed: | |] February 15, 2018 | [removed: | |] 000-19319 | [removed: | |]
| 4.2 | [removed: | |] [Description of Securities.](https://www.sec.gov/Archives/edgar/data/875320/000087532025000053/a10k_2024-exhibit42.htm) | | [removed: | X | | | | | | | | |] [added: 10-K (Exhibit 4.2)] | [added: February 13, 2025] | [added: 000-19319] |
| Collaboration Agreement | | | | | | [removed: | | | | | | | | | | | |]
| 10.1 | [removed: | |] [Research, Development and Commercialization Agreement, dated as of May [removed: 24, 2004,] [added: 24,](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit101.htm) [2004,] between Vertex Pharmaceuticals Incorporated and Cystic [removed: Fibrosis Foundation] [added: Fibrosis](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit101.htm) [Foundation] Therapeutics Incorporated.†](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit101.htm) | | [removed: | | | |] 10-Q (Exhibit 10.1) | [removed: | |] November 3, 2021 | [removed: | |] 000-19319 | [removed: | |]
| 10.2 | [removed: | |] [Amendment No. 1 to Research, Development and Commercialization [removed: Agreement, dated] [added: Agreement,](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit102.htm) [dated] as of January 6, 2006, between Vertex Pharmaceuticals Incorporated [removed: and Cystic] [added: and](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit102.htm) [Cystic] Fibrosis Foundation Therapeutics Incorporated.†](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit102.htm) | | [removed: | | | |] 10-Q (Exhibit 10.2) | [removed: | |] November 3, 2021 | [removed: | |] 000-19319 | [removed: | |]
| 10.3 | [removed: | |] [Amendment No. 2 to Research, Development and Commercialization [removed: Agreement, dated] [added: Agreement,](https://www.sec.gov/Archives/edgar/data/875320/000110465911047955/a11-13893_4ex10d6.htm) [dated] as of March 17, 2006, between Vertex Pharmaceuticals Incorporated [removed: and Cystic] [added: and](https://www.sec.gov/Archives/edgar/data/875320/000110465911047955/a11-13893_4ex10d6.htm) [Cystic] Fibrosis Foundation Therapeutics Incorporated.](https://www.sec.gov/Archives/edgar/data/875320/000110465911047955/a11-13893_4ex10d6.htm) | | [removed: | | | |] 10-Q/A (Exhibit 10.6) | [removed: | |] August 19, 2011 | [removed: | |] 000-19319 | [removed: | |]
| 10.4 | [removed: | |] [Amendment No. 5 to Research, Development and Commercialization [removed: Agreement, effective] [added: Agreement,](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit103.htm) [effective] as of April 1, 2011, between Vertex Pharmaceuticals Incorporated [removed: and Cystic] [added: and](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit103.htm) [Cystic] Fibrosis Foundation Therapeutics Incorporated.†](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit103.htm) | | [removed: | | | |] 10-Q (Exhibit 10.3) | [removed: | |] November 3, 2021 | [removed: | |] 000-19319 | [removed: | |]
| 10.5 | [removed: | |] [Amendment No. 7 to Research, Development and Commercialization [removed: Agreement, dated] [added: Agreement,](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit104.htm) [dated] October 13, 2016, between Vertex Pharmaceuticals Incorporated and [removed: Cystic Fibrosis] [added: Cystic](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit104.htm) [Fibrosis] Foundation Therapeutics Incorporated.†](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000033/a2021q310-qexhibit104.htm) | | [removed: | | | |] 10-Q (Exhibit 10.4) | [removed: | |] November 3, 2021 | [removed: | |] 000-19319 | [removed: | |]
| 10.6 | [removed: | |] [Amended and Restated Joint Development and Commercialization [removed: Agreement, dated] [added: Agreement,](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000027/a2021q210-qexhibit101.htm) [dated] April 16, 2021, between Vertex Pharmaceuticals Incorporated, [removed: Vertex Pharmaceuticals] [added: Vertex](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000027/a2021q210-qexhibit101.htm) [Pharmaceuticals] (Europe) Limited and CRISPR Therapeutics AG, [removed: CRISPR Therapeutics] [added: CRISPR](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000027/a2021q210-qexhibit101.htm) [Therapeutics] Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.†](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000027/a2021q210-qexhibit101.htm) | | [removed: | | | |] 10-Q (Exhibit 10.1) | [removed: | |] July 30, 2021 | [removed: | |] 000-19319 | [removed: | |]
| 10.7 | [removed: | |] [Amendment No. 1 to Amended and Restated Joint Development [removed: and Commercialization] [added: and](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm) [Commercialization] Agreement, dated [removed: December](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm) [1](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm)[2, 2](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm)[0](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm)[23,] [added: December 12, 2023,] between [removed: Vertex Pharmaceuticals] [added: Vertex](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm) [Pharmaceuticals] Incorporated, Vertex Pharmaceuticals (Europe) Limited [removed: and CRISPR] [added: and](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm) [CRISPR] Therapeutics AG, CRISPR Therapeutics Limited, [removed: CRISPR Therapeutics,] [added: CRISPR](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm) [Therapeutics,] Inc., TRACR Hematology Ltd.†](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit107.htm) | | [removed: | | | |] 10-K (Exhibit 10.7) | [removed: | |] February 15, 2024 | [removed: | |] 000-19319 | [removed: | |]
| Leases | | | | | | [removed: | | | | | | | | | | | |]
| 10.8 | [removed: | |] [Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and [removed: Vertex Pharmaceuticals] [added: Vertex](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000027/a2021q210-qexhibit102.htm) [Pharmaceuticals] Incorporated.†](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000027/a2021q210-qexhibit102.htm) | | [removed: | | | |] 10-Q (Exhibit 10.2) | [removed: | |] July 30, 2021 | [removed: | |] 000-19319 | [removed: | |]
| 10.9 | [removed: | |] [2024 Amendment to the Lease (50 Northern Avenue), dated August 15, [removed: 2024, between] [added: 2024,](https://www.sec.gov/Archives/edgar/data/875320/000087532024000223/a2024q310-qexhibit101.htm) [between] Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. †](https://www.sec.gov/Archives/edgar/data/875320/000087532024000223/a2024q310-qexhibit101.htm) | | [removed: | | | |] 10-Q (Exhibit 10.1) | [removed: | |] November 5, 2024 | [removed: | |] 000-19319 | [removed: | |]
| 10.10 | [removed: | |] [Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and [removed: Vertex Pharmaceuticals] [added: Vertex](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000027/a2021q210-qexhibit103.htm) [Pharmaceuticals] Incorporated.†](https://www.sec.gov/Archives/edgar/data/0000875320/000087532021000027/a2021q210-qexhibit103.htm) | | [removed: | | | |] 10-Q (Exhibit 10.3) | [removed: | |] July 30, 2021 | [removed: | |] 000-19319 | [removed: | |]
| 10.11 | [removed: | |] [2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, [removed: 2024, between] [added: 2024,](https://www.sec.gov/Archives/edgar/data/875320/000087532024000223/a2024q310-qexhibit102.htm) [between] Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.†](https://www.sec.gov/Archives/edgar/data/875320/000087532024000223/a2024q310-qexhibit102.htm) | | [removed: | | | |] 10-Q (Exhibit 10.2) | [removed: | |] November 5, 2024 | [removed: | |] 000-19319 | [removed: | |]
| Financing Agreements | | | | | | [removed: | | | | | | | | | | | |]
| 10.12 | [removed: | |] [Credit Agreement, dated as of July 1, 2022, by and among [removed: Vertex Pharmaceuticals] [added: Vertex](https://www.sec.gov/Archives/edgar/data/875320/000087532022000030/a2022q210-qexhibit101.htm) [Pharmaceuticals] Incorporated, Bank of America, N.A. and the other lenders [removed: party thereto.](https://www.sec.gov/Archives/edgar/data/875320/000087532022000030/a2022q210-qexhibit101.htm) | | | |] [added: party](https://www.sec.gov/Archives/edgar/data/875320/000087532022000030/a2022q210-qexhibit101.htm) [thereto.](https://www.sec.gov/Archives/edgar/data/875320/000087532022000030/a2022q210-qexhibit101.htm)] | | 10-Q (Exhibit 10.1) | [removed: | |] August 5, 2022 | [removed: | |] 000-19319 | [removed: | |]
| 10.13 | [removed: | |] [First Amendment to Credit Agreement, dated June 20, 2024 by and [removed: between Vertex] [added: between](https://www.sec.gov/Archives/edgar/data/875320/000087532024000198/a2024q210-qexhibit101.htm) [Vertex] Pharmaceuticals Incorporated and Bank of America N.A.](https://www.sec.gov/Archives/edgar/data/875320/000087532024000198/a2024q210-qexhibit101.htm) | | [removed: | | | |] 10-Q (Exhibit 10.1) | [removed: | |] August 2, 2024 | [removed: | |] 000-19319 | [removed: | |]
| Equity Plans | | | | | | [removed: | | | | | | | | | | | |]
| 10.14 | [removed: | |] [Amended and Restated 2006 Stock and Option Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000087532018000029/a2018q310-q_exhibit101.htm) | | [removed: | | | |] 10-Q (Exhibit 10.1) | [removed: | |] October 25, 2018 | [removed: | |] 000-19319 | [removed: | |]
| 10.15 | [removed: | |] [Form of Stock Option Agreement under Amended and Restated 2006 Stock [removed: and Option] [added: and](https://www.sec.gov/Archives/edgar/data/875320/000087532015000012/vrtx10k_2014-exhibit1020.htm) [Option] Plan (granted on or after July 30, 2013).*](https://www.sec.gov/Archives/edgar/data/875320/000087532015000012/vrtx10k_2014-exhibit1020.htm) | | [removed: | | | |] 10-K (Exhibit 10.20) | [removed: | |] February 13, 2015 | [removed: | |] 000-19319 | [removed: | |]
| 10.16 | [removed: | |] [Amended and Restated 2013 Stock and Option Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000130817922000210/lvrtx2022_def14a.htm) | | [removed: | | | |] DEF 14A (Appendix A) | [removed: | |] April 7, 2022 | [removed: | |] 000-19319 | [removed: | |]
| 10.17 | [removed: | |] [Form of Non-Qualified Stock Option Agreement under 2013 Stock and [removed: Option Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000087532015000012/vrtx10k_2014-exhibit1017.htm) | | | |] [added: Option](https://www.sec.gov/Archives/edgar/data/875320/000087532015000012/vrtx10k_2014-exhibit1017.htm) [Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000087532015000012/vrtx10k_2014-exhibit1017.htm)] | | 10-K (Exhibit 10.17) | [removed: | |] February 13, 2015 | [removed: | |] 000-19319 | [removed: | |]
| 10.18 | [removed: | |] [Form of Restricted Stock Unit Agreement under 2013 Stock and Option [removed: Plan (U.S.).*](https://www.sec.gov/Archives/edgar/data/875320/000087532016000067/vrtx10k_2015-exhibit1025.htm) | | | |] [added: Plan](https://www.sec.gov/Archives/edgar/data/875320/000087532016000067/vrtx10k_2015-exhibit1025.htm) [(U.S.).*](https://www.sec.gov/Archives/edgar/data/875320/000087532016000067/vrtx10k_2015-exhibit1025.htm)] | | 10-K (Exhibit 10.25) | [removed: | |] February 16, 2016 | [removed: | |] 000-19319 | [removed: | |]
| 10.19 | [removed: | |] [Form of Restricted Stock Unit Agreement under 2013 Stock and Option [removed: Plan (International).*](https://www.sec.gov/Archives/edgar/data/875320/000087532015000012/vrtx10k_2014-exhibit1019.htm) | | | |] [added: Plan](https://www.sec.gov/Archives/edgar/data/875320/000087532015000012/vrtx10k_2014-exhibit1019.htm) [(International).*](https://www.sec.gov/Archives/edgar/data/875320/000087532015000012/vrtx10k_2014-exhibit1019.htm)] | | 10-K (Exhibit 10.19) | [removed: | |] February 13, 2015 | [removed: | |] 000-19319 | [removed: | |]
| 10.20 | [removed: | |] [Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000087532020000007/a10k2019-exhibit1017.htm) | | [removed: | | | |] 10-K (Exhibit 10.17) | [removed: | |] February 13, 2020 | [removed: | |] 000-19319 | [removed: | |]
| 10.21 | [removed: | |] [Form of Restricted Stock Unit Agreement under 2013 Stock and Option [removed: Plan (granted] [added: Plan](https://www.sec.gov/Archives/edgar/data/875320/000087532025000053/a10k_2024-exhibit1021.htm) [(granted] on or after January 1, 2025).*](https://www.sec.gov/Archives/edgar/data/875320/000087532025000053/a10k_2024-exhibit1021.htm) | | [removed: | X | | | | | | | | |] [added: 10-K (Exhibit 10.21)] | [added: February 13, 2025] | [added: 000-19319] |
| 10.22 | [removed: | |] [Form of Restricted Stock Unit Agreement (with performance conditions) [removed: under 2013] [added: under](https://www.sec.gov/Archives/edgar/data/875320/000087532025000053/a10k_2024-exhibit1022.htm) [2013] Stock and Option Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000087532025000053/a10k_2024-exhibit1022.htm) | | [removed: | X | | | | | | | | |] [added: 10-K (Exhibit 10.22)] | [added: February 13, 2025] | [added: 000-19319] |
| 10.23 | [removed: | |] [Non-Employee Director Deferred Compensation Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000087532016000067/vrtx10k_2015-exhibit1027.htm) | | [removed: | | | |] 10-K (Exhibit 10.27) | [removed: | |] February 16, 2016 | [removed: | |] 000-19319 | [removed: | |]
| 10.24 | [removed: | |] [Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000130817919000189/lvrt2019_def14a.htm) | | [removed: | | | |] DEF 14A (Appendix B) | [removed: | |] April 26, 2019 | [removed: | |] 000-19319 | [removed: | |]
follows:
| | |
| --- | --- |
| Consolidated Statements of Income (Loss) ......................................................................................................................... | F-[3](#ib44b4620d6d245e0bae824a83c255a23_187) |
| Consolidated Statements of Comprehensive Income (Loss) ............................................................................................... | F-[4](#ib44b4620d6d245e0bae824a83c255a23_190) |
| Consolidated Balance Sheets ............................................................................................................................................... | F-[5](#ib44b4620d6d245e0bae824a83c255a23_193) |
| Consolidated Statements of Shareholders’ Equity ............................................................................................................... | F-[6](#ib44b4620d6d245e0bae824a83c255a23_196) |
| Consolidated Statements of Cash Flows .............................................................................................................................. | F-[7](#ib44b4620d6d245e0bae824a83c255a23_199) |
information is included in the consolidated financial statements or notes thereto listed in (a)(1) above.
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| Exhibit Number | Exhibit Description | Filed with this report | Incorporated by Reference herein from—Form or Schedule | Filing Date/ Period Covered | SEC File/ Reg. Number |
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| Exhibit Number | Exhibit Description | Filed with this report | Incorporated by Reference herein from—Form or Schedule | Filing Date/ Period Covered | SEC File/ Reg. Number |
| 10.38 | [Employment Agreement, dated February 7, 2025, by and between Vertex](https://www.sec.gov/Archives/edgar/data/875320/000087532025000192/a2025q110-qexhibit101.htm) [Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*](https://www.sec.gov/Archives/edgar/data/875320/000087532025000192/a2025q110-qexhibit101.htm) | | 10-Q (Exhibit 10.1) | May 6, 2025 | 000-19319 |
| 10.42 | [Employment Agreement, dated October 3, 2022, by and between Vertex](https://www.sec.gov/Archives/edgar/data/875320/000087532026000056/a10k_2025-exhibit1042.htm) [Pharmaceuticals Incorporated and Carmen Bozic.*](https://www.sec.gov/Archives/edgar/data/875320/000087532026000056/a10k_2025-exhibit1042.htm) | X | | | |
| 10.44 | [Vertex Pharmaceuticals Employee Compensation Plan.*](https://www.sec.gov/Archives/edgar/data/875320/000087532026000056/a10k_2025-exhibit1044.htm) | X | | | |
| | | | | | |
| --- | --- | --- | --- | --- | --- |
| Exhibit Number | Exhibit Description | Filed with this report | Incorporated by Reference herein from—Form or Schedule | Filing Date/ Period Covered | SEC File/ Reg. Number |
| | | | | | |
| Consolidated Statements of Income for the years ended December 31, 2024, 2023 and 2022 | | | F-[4](#ie9f459f6387e4b038fe2ec4558eff10a_184) | | |
| Consolidated Statements of Comprehensive Income for the years ended December 31, 2024, 2023 and 2022 | | | F-[5](#ie9f459f6387e4b038fe2ec4558eff10a_187) | | |
| Consolidated Balance Sheets as of December 31, 2024 and 2023 | | | F-[6](#ie9f459f6387e4b038fe2ec4558eff10a_190) | | |
| Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2024, 2023 and 2022 | | | F-[7](#ie9f459f6387e4b038fe2ec4558eff10a_193) | | |
| Consolidated Statements of Cash Flows for the years ended December 31, 2024, 2023 and 2022 | | | F-[8](#ie9f459f6387e4b038fe2ec4558eff10a_196) | | |
| | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 97.1 | | | [Policy Relating to Recovery of Erroneously Awarded Compensation](https://www.sec.gov/Archives/edgar/data/875320/000087532024000062/a10k_2023-exhibit971.htm) | | | | | | 10-K (Exhibit 97.1) | | | February 15, 2024 | | | 000-19319 | | |
An excerpt. Shown here: 40 of 80 rewritten, all 22 added and all 8 removed. The counts are complete. For every sentence, read Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES in the FY2025 filing and the FY2024 filing.
Item 16. FORM 10-K SUMMARY
875 rewritten, 1,200 added, 205 removed, 322 unchanged
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly [removed: caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.]
| | [removed: | |] Vertex Pharmaceuticals Incorporated | | [removed: | | | |]
| February 13, [removed: 2025 | |] [added: 2026] | By: | [removed: | |] /s/ Reshma Kewalramani | [removed: | |]
| | | [removed: | | | |] Reshma Kewalramani *Chief Executive Officer* | [removed: | |]
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following [removed: persons on behalf of the registrant and in the capacities and on the dates indicated.]
| | [removed: | |] Name | | | | | [removed: | | | | | | | | | |] Title | | | | [removed: | | | | | | | |] Date | | | | [removed: | | | | | | | |]
| /s/ Reshma Kewalramani | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Reshma Kewalramani | | | | [removed: | | | | | | | |] President, Chief Executive Officer and Director (Principal Executive Officer) | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Charles F. Wagner, Jr. | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Charles F. Wagner, Jr. | | | | [removed: | | | | | | | |] Executive Vice President and Chief [added: Operating &] Financial Officer (Principal Financial Officer) | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Kristen C. Ambrose | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Kristen C. Ambrose | | | | [removed: | | | | | | | |] Senior Vice President and Chief Accounting Officer (Principal Accounting Officer) | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/Jeffrey M. Leiden | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Jeffrey M. Leiden | | | | [removed: | | | | | | | |] Executive Chairman | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Sangeeta N. Bhatia | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Sangeeta N. Bhatia | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Lloyd Carney | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Lloyd Carney | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Alan Garber | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Alan Garber | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Michel Lagarde | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Michel Lagarde | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Diana McKenzie | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Diana McKenzie | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Nancy A. Thornberry | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Nancy A. Thornberry | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Bruce I. Sachs | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Bruce I. Sachs | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Jennifer Schneider | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Jennifer Schneider | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
| /s/ Suketu Upadhyay | | | | | | | | | | | | | | [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]
| Suketu Upadhyay | | | | [removed: | | | | | | | |] Director | | | | | [removed: | | | | | | | | | |] February 13, [removed: 2025 | | | | | | | | | |] [added: 2026] | | | | |
[removed: We have audited the accompanying consolidated balance sheets of Vertex Pharmaceuticals Incorporated (the Company) as of December 31, 2024 and 2023, the related consolidated statements of income, comprehensive income,] shareholders’ equity and cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] and the related notes [removed: (collectively referred to as the “consolidated financial statements”).]
[removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position] of [removed: the Company at December 31, 2024 and 2023, and the results of] its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] in conformity with [removed: U.S. generally accepted accounting principles.]
[removed: Our responsibility is to express an opinion] on the Company’s financial statements based on our audits.
[removed: We] are [removed: a public accounting firm registered with the PCAOB and are] required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the [removed: applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.]
[removed: Those standards require that we plan and perform] the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due [removed: to error or fraud.]
[removed: Our audits included performing procedures to assess the risks of material misstatement of the financial] statements, whether due to error or fraud, and performing procedures that respond to those risks.
[removed: Such procedures included] examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
[removed: Our audits also] included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the [removed: overall presentation of the financial statements.]
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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persons on behalf of the registrant and in the capacities and on the dates indicated.
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We have audited the accompanying consolidated balance sheets of Vertex Pharmaceuticals Incorporated (the Company) as of
December 31, 2025 and 2024, the related consolidated statements of income (loss), comprehensive income (loss),
(collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements
present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results
U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States)
(PCAOB), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in
Internal Control*—*Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission
(2013 framework), and our report dated February 13, 2026 expressed an unqualified opinion thereon.
Our responsibility is to express an opinion
We are a public accounting firm registered with the PCAOB and
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
Those standards require that we plan and perform
to error or fraud.
Our audits included performing procedures to assess the risks of material misstatement of the financial
Such procedures included
Our audits also
overall presentation of the financial statements.
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that
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We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 13, 2025, expressed an unqualified opinion thereon.
| *Description of the Matter* | | | | | | As described in Note B to the consolidated financial statements, on May 20, 2024, the Company acquired Alpine Immune Sciences, Inc. (“Alpine”), a publicly traded biotechnology company focused on discovering and developing innovative, protein-based immunotherapies for approximately $5.0 billion in cash. The Company determined substantially all the fair value of the gross assets acquired were concentrated in Alpine’s lead molecule, povetacicept. Therefore, the Company accounted for the Alpine transaction as an asset acquisition under U.S. GAAP. The acquired in-process research and development asset was valued at $4.4 billion, which was expensed on the date of acquisition as it did not have alternative future use at the acquisition date. Auditing the fair value of the in-process research and development assets acquired in the Alpine transaction was judgmental due to the significant estimation uncertainty and subjectivity of the significant assumptions used by management in determining the present value of future discounted cash flows. The significant assumptions used in determining the fair value of the in-process research and development assets acquired included the amount and timing of future product revenues, the discount rate and probability of technical and regulatory success. The valuation of the in-process research and development assets is sensitive to these significant assumptions. | | |
| *How We Addressed the Matter in Our Audit* | | | | | | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over management’s review of the valuation of the in-process research and development assets of Alpine. For example, we tested controls over management’s review of the significant assumptions and the completeness and accuracy of the data used in the valuation. To test the fair value of the povetacicept in-process research and development assets, we performed audit procedures that included, among others, evaluating the Company's methodologies used and testing the significant assumptions discussed above. For example, we compared the significant assumptions used by management to current published scientific studies, industry, market and economic trends, and to other relevant factors. In addition, to evaluate the probability of technical and regulatory success, we considered the phase of development of the in-process research and development assets and compared the Company’s assumptions to third-party data regarding clinical trial success rates. We also performed various sensitivity analyses of the significant assumptions to evaluate the change in the fair value of the in-process research and development assets resulting from changes in the assumptions. In addition, we involved our valuation specialists to assist in our evaluation of the methodologies and the discount rate used in the fair value estimates. | | |
February 13, 2025
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| Basic | | | $ | (2.08) | | | | | $ | 14.05 | | | | | $ | 12.97 | |
| Diluted | | | $ | (2.08) | | | | | $ | 13.89 | | | | | $ | 12.82 | |
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| Accounts payable | | | $ | 413.0 | | | | | $ | 364.9 | |
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| Balance at December 31, 2021 | | | 254.5 | | | | | | $ | 2.5 | | | | | $ | 6,880.8 | | | | | $ | 15.9 | | | | | $ | 3,200.8 | | | | | $ | 10,100.0 | |
| Losses on equity securities | | | 57.7 | | | | | | 0.6 | | | | | | 149.1 | | |
| Decrease in fair value of contingent consideration | | | (0.5) | | | | | | (51.6) | | | | | | (57.5) | | |
| Payment to acquire ViaCyte, Inc., net of cash acquired | | | — | | | | | | — | | | | | | (295.9) | | |
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 pipeline includes clinical-stage 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 (“T1D”), myotonic dystrophy type 1 (“DM1”), and autosomal dominant polycystic kidney disease.
We have received approval to market CASGEVY (exagamglogene autotemcel), a gene-therapy, for the treatment of SCD or TDT in the United States (“U.S.”), the European Union (“E.U.”), the United Kingdom (“U.K.”), the Kingdom of Saudi Arabia, the Kingdom of Bahrain, the United Arab Emirates, Canada and Switzerland.
We apply the following five-step model to determine this amount: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation.
In the U.S., we also sell certain products to major wholesalers.
Revenues from product sales are recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration that result from (a) invoice discounts for prompt payment and distribution fees, (b) government and private payor rebates, chargebacks, discounts and fees, (c) product returns, and (d) other incentives for certain indirect customers, including costs of co-pay assistance programs for patients.
Where appropriate, we utilize the expected value method to determine the appropriate amount for estimates of variable consideration based on factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns.
*Other Incentives:* Other incentives that we offer include co-pay mitigation rebates that we provide in the U.S. to commercially insured patients who have coverage and who reside in states that permit co-pay mitigation programs.
Based upon the terms of our co-pay mitigation programs, we estimate average co-pay mitigation amounts for each of our products to establish appropriate accruals.
We provide to employees who have rendered a certain number of years of service to Vertex and meet certain age requirements, partial or full acceleration of vesting of these equity awards, subject to certain conditions including a notification period, upon a termination of employment other than for cause.
Research and development expenses are comprised of costs we incur in performing research and development activities, including salary and benefits; stock-based compensation expense; outsourced services and other direct expenses, including clinical trial, pharmaceutical development and drug supply costs; intangible asset impairment charges; and infrastructure costs, including facilities costs and depreciation expense.
*Cloud Computing Service Contracts*
A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to Vertex by the end of the lease term, (ii) we hold an option to purchase the leased asset that we are reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, or (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term.
We record the fair value of in-process research and development assets as of the transaction date of a business combination on our consolidated balance sheets as “Other intangible assets, net.” These assets are used in research and development activities but have not yet reached technological feasibility, which occurs when we complete the research and development efforts by obtaining regulatory approval to market an underlying product candidate.
We amortize our finite-lived intangible assets related to our marketed products using the straight-line method within “Cost of sales” over the remaining estimated life of the assets beginning in the period in which regulatory approval is achieved or the assets are acquired and continuing through the period that we no longer have either exclusive rights to market the products associated with the assets or in-license rights to the intellectual property underlying the assets.
For purposes of comprehensive income disclosures, we record provisions for or benefits from income taxes related to the unrealized gains and losses on foreign currency forward contracts and our available-for-sale debt securities.
Changes resulting from foreign currency translation are included in “Accumulated other comprehensive income (loss).” Net foreign currency exchange transaction losses, which are included in “Other expense, net” on our consolidated statements of income, were $27.3 million, $24.6 million and $15.1 million for 2024, 2023 and 2022, respectively.
In 2023, the FASB issued ASU 2023-09, *Income Taxes (Topic 740): Improvements to Income Tax Disclosures* (“ASU 2023-09”), which requires public entities to disclose in their rate reconciliation table additional categories of information about federal, state and foreign income taxes and to provide more details about the reconciling items in some categories if items meet a quantitative threshold.
In 2024, the FASB issued ASU 2024-03, *Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses* (“ASU 2024-03”), which requires public entities, among other items, to disclose in a tabular format, on an annual and interim basis, purchases of inventory, employee compensation, depreciation, intangible asset amortization and depletion for each income statement line item that contains those expenses.
An excerpt. Shown here: 40 of 875 rewritten, 40 of 1,200 added and 40 of 205 removed. The counts are complete. For every sentence, read Item 16. FORM 10-K SUMMARY in the FY2025 filing and the FY2024 filing.