VERTEX PHARMACEUTICALS INC / MA
For the period ended Jun 30, 2026. Filed Aug 4, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 4, 2026
VRTX$547.09+0.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-05.
0000875320-26-000173
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-04.
0000875320-26-000259
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 338 previous paragraphs and 379 current paragraphs.
216 unchanged; 72 reworded; 88 added; 50 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 11 previous and 11 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (88)
Current report
•In the second quarter of 2026, we secured reimbursement for ALYFTREK in four additional countries, including
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Spain, bringing the total number of countries where ALYFTREK is reimbursed to 25. We also signed a letter of
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intent with the Pan-Canadian Pharmaceutical Alliance for reimbursement of ALYFTREK for eligible patients six
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years of age and older in Canada.
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increase compared to the first quarter of 2026 and a 151% increase compared to the second quarter of 2025.
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with SCD or TDT, making it the first genetic therapy indicated for children as young as two years of age for both
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SCD and TDT. Approximately 5,500 patients with SCD or TDT may be eligible for treatment with CASGEVY for
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the first time with this approval. We also completed regulatory submissions in the Kingdom of Saudi Arabia (“Saudi
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Arabia”) and the United Kingdom for the treatment of children five to eleven years of age.
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Germany. We are committed to working with government and reimbursement authorities globally to ensure
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sustainable access for eligible patients.
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•In the second quarter of 2026, we recorded$49.6 million of JOURNAVX product revenues, representing a 71%
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increase compared to the first quarter of 2026 and a more than 300% increase compared to the second quarter of
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•In the second quarter and first six months of 2026, approximately 535,000 and 900,000 prescriptions, respectively,
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JOURNAVX. As a result, seniors covered by three of the four major Medicare Part D pharmacy benefit managers
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and government payers.
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years of age, we initiated global regulatory submissions for this age group.
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Acute and Peripheral Neuropathic Pain
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•During the second quarter of 2026, Health Canada accepted our new drug submission for suzetrigine for the
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treatment of moderate-to-severe acute pain, and review is underway.
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•The FDA accepted our biologics license application for accelerated approval of povetacicept for adults with IgAN
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and assigned a PDUFA target action date of November 30, 2026. If approved, povetacicept will become the first
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commercialized therapy in our emerging nephrology franchise.
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•We have completed our regulatory submission for accelerated approval of povetacicept in adults with IgAN in Saudi
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Arabia, and the Saudi Food and Drug Authority has granted Breakthrough Designation to povetacicept.
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Phase 3 portion, which is underway.
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of 2026.
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been treated for 48 weeks.
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•The FDA cleared the Investigational New Drug Application for VX-017, our stem cell-derived, fully differentiated
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islet cell therapy designed to treat all eligible patients with T1D, regardless of blood type. We plan to initiate a Phase
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1/2 clinical trial to evaluate the safety and efficacy of VX-017 in people with T1D in the near term.
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Investment in External Innovation
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•In July, we entered into an agreement and plan of merger (the “Crinetics Merger Agreement”) to acquire all of the
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issued and outstanding shares of common stock of Crinetics Pharmaceuticals, Inc. (“Crinetics”)for $85.00 per share
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in cash, for a total equity value of approximately $10.0 billion (the “Crinetics Acquisition”). We expect the
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transaction to close in the third quarter of 2026, subject to certain customary conditions. Crinetics’ PALSONIFY®
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(paltusotine) is a once-daily oral therapy for adults with acromegaly, a rare and debilitating condition caused by a
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pituitary tumor that secretes excess growth hormone, who had an inadequate response to surgery and/or for whom
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surgery is not an option. PALSONIFY is approved by the FDA and the European Medicines Agency, and is under
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review by other global regulatory bodies. Crinetics’ most advanced pipeline candidate, atumelnant, is a once-daily
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expanding availability of these medicines to approximately 95% of all people with CF in the United States (the
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“U.S.”). With these label extensions, approximately 800 people with CF in the U.S. are newly eligible for a
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medicine that treats the underlying cause of CF.
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•We secured reimbursement agreements for ALYFTREK in Scotland, Spain, Sweden, Switzerland, New Zealand,
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Israel, and Finland, and we are working to secure access for eligible patients in additional countries.
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working through final implementation to provide long-term reimbursed access to patients at a sustainable price.
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•We completed the regulatory submission in the U.S. for approval of CASGEVY in children with SCD or TDT five
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to less than twelve years of age. The FDA awarded a Commissioner’s National Priority Voucher for this pediatric
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submission, indicating an accelerated timeline for review once the submission is accepted.
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•Since the launch of JOURNAVX in March 2025, more than 1 million prescriptions have been filled for
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2026, more than 350,000 prescriptions were filled, and we recorded $29 million of JOURNAVX product revenues.
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JOURNAVX effective on May 1. This agreement adds approximately 10 million lives covered under Part D.
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to submit for global regulatory approvals in this age group in the first half of 2026. We continue to enroll and dose
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patients in the pivotal clinical trial evaluating ALYFTREK in children with CF one to less than two years of age.
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•Following positive results from the TRIKAFTA clinical trial inchildren one to less than two years of age, we have
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begun submissions for global regulatory approvals in this age group.
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Peripheral Neuropathic Pain
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•Following positive results from the RAINIER Phase 3 clinical trial evaluating povetacicept in adults with IgAN, we
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completed in March the submission of the rolling biologics license application (“BLA”) to the FDA for potential
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accelerated approval in the U.S. We are using a Priority Review Voucher and therefore expect the FDA review of
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this BLA to be expedited to six months from the date of the FDA’s acceptance of the BLA.
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of this clinical trial. Enrollment and dosing in this clinical trial are ongoing.
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enrollment in the interim analysis cohort of the global AMPLITUDE Phase 2/3 pivotal clinical trial evaluating
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dosing in this clinical trial. Multiple people with T1D have been treated since the resumption of dosing. In 2026, we
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whether we conclude the transactions represent business combinations or asset acquisitions. In 2024, we acquired Alpine
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areas.
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collaboration agreement with Zai.
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Revenues by Geographic Location
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compared to thefirst quarter of 2025, primarily dueto strong CF performance across multiple geographies, including
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increased our salary and benefits and infrastructure costs in thefirst quarter of 2026 as compared to thefirst quarter of 2025.
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diseases.
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acquisitions.
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povetacicept in IgAN.
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in thefirst quarter of 2025. Our future net interest income is primarily dependent on the amount of, and prevailing market
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interest rates on our outstanding cash, cash equivalents and available-for-sale debt securities.
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Other income (expense), net was$0.0 million in thefirst quarter of 2026 and netexpenses of$17.6 million in thefirst
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quarter of 2025. Our other income (expense), net primarily relates to net unrealized and realized losses resulting from
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tax liabilities, and cash taxes.
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Our effective taxrates of 17.7% and 11.5% in thefirst quarter of 2026 and 2025, respectively, were lower than the U.S.
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our growing portfolio of products, partially offsetby tax accruals and payments.
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Reworded paragraphs (72)
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Recent and anticipated progress in activities expanding our CF business is included below:
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Recent progress in activities expanding our CF business is included below:
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•In the first quarter of 2026, we recorded $43 million of CASGEVY product revenues.
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•In the second quarter of 2026, we recorded$76.4 million of CASGEVY product revenues, representing a 78%
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•The U.S. Food and Drug Administration (the “FDA”) approved label extensions for ALYFTREK and TRIKAFTA,
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•The U.S. Food and Drug Administration (the “FDA”) approved CASGEVY in children two years of age and older
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•We secured a pricing agreement for CASGEVY for eligible patients with SCD or TDT in Germany, and we are
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•In May, we secured reimbursement for CASGEVY for eligible patients 12 years and older with SCD or TDT in
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JOURNAVX across the hospital and retail settings for a broad range of acute pain conditions. In the first quarter of
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have been filled for JOURNAVX across the hospital and retail settings.
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•We have reached an agreement with a major pharmacy benefit manager for Medicare Part D coverage for
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•We have reached agreements with two additional major pharmacy benefit managers for Medicare Part D coverage of
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Twenty-two states provide coverage for JOURNAVX via Medicaid. In total, approximately 240 million individuals
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have reimbursed access. Twenty-three states provide coverage for JOURNAVX via Medicaid. In total,
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have reimbursed access to JOURNAVX across a wide range of commercial and government payers.
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approximately 260 million individuals have reimbursed access to JOURNAVX across a wide range of commercial
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•Following positive results from the ALYFTREK clinical trial in children with CF two to five years of age, we expect
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•Following positive results from the Phase 3 clinical trial evaluating ALYFTREK in children with CF two to five
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nephropathy (“pMN”), another B cell-mediated disease. We completed enrollment in the Phase 2 portion of the
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nephropathy (“pMN”), another B cell-mediated disease. We completed the Phase 2B portion of the Phase 2/3
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Phase 2/3 OLYMPUS pivotal trial evaluating povetacicept in people with pMN, and we initiated the Phase 3 portion
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OLYMPUS pivotal trial evaluating povetacicept in people with pMN, and we confirmed the dose selection for the
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•Inaxaplin is our small molecule for the treatment of APOL1-mediated kidney disease (“AMKD”). We completed
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•Inaxaplin is our small molecule for the treatment of APOL1-mediated kidney disease (“AMKD”). We expect to
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complete full enrollment in the AMPLITUDE clinical trial in the second half of 2026.
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complete full enrollment in the AMPLITUDE Phase 2/3 pivotal clinical trial evaluating inaxaplin in the second half
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has been treated for 48 weeks. We expect to share data from the interim analysis in early 2027. We expect to
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•We expect to share data from the interim analysis of the AMPLITUDE clinical trial in early 2027. We expect to
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inaxaplin. We expect to conduct the pre-planned interim analysis for potential accelerated approval once this cohort
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conduct the pre-planned interim analysis for potential U.S. accelerated approval once the interim analysis cohort has
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using standard immunosuppression to protect the implanted cells. We have completed the internal manufacturing
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using standard immunosuppression to protect the implanted cells. We are enrolling and dosing patients in the Phase
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analysis for the Phase 1/2/3 clinical trial of zimislecel in people with type 1 diabetes (“T1D”), and we have resumed
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1/2/3 clinical trial of zimislecel in people with type 1 diabetes (“T1D”).
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expect to provide updated timelines for trial completion.
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•We expect to provide updated timelines for the zimislecel and VX-017 programs in 2026.
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In thefirst quarter of 2026, our total product revenues came primarily from the sale of our medicines for the treatment of
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In thefirst half of 2026, our total product revenues came primarily from the sale of our medicines for the treatment of
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provide benefitsto all people with CFand increasing the number of people with CF eligible and able to receive our
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provide benefits to all people with CF and increasing the number of people with CF eligible and able to receive our
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of IgAN. In addition, weare advancing our pipeline of product candidates for the treatment of serious diseases outside of CF,
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of IgAN. In addition, we are advancing our pipeline of product candidates for the treatment of serious diseases outside of CF,
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to continue to identify and evaluate such opportunities. The accounting for these acquisitions can vary significantly based on
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to continue to identify and evaluate such opportunities. The accounting for an acquisition can vary significantly based on
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Immune Sciences, Inc. (“Alpine”) and its lead molecule, povetacicept, for approximately $5.0 billion. Povetacicept, has
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In 2024, we acquired Alpine Immune Sciences, Inc. (“Alpine”) and its lead molecule, povetacicept, for approximately
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shown potential to treat multiple diseases or conditions and become a pipeline-in-a-product. We accounted for the Alpine
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$5.0 billion. Povetacicept, has shown potential to treat multiple diseases or conditions and become a pipeline-in-a-product.
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transaction as an asset acquisition because povetacicept represented substantially all of the fair value of the gross assets that
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We accounted for the Alpine transaction as an asset acquisition because povetacicept represented substantially all of the fair
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we acquired. As a result, $4.4 billion of the fair value attributed to povetacicept was expensed as AIPR&D in 2024.
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value of the gross assets that we acquired. As a result, $4.4 billion of the fair value attributed to povetacicept was expensed as
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In thefirst quarter of 2026 and 2025, our AIPR&D included$0.5 million and$19.8 million, respectively, related to
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In thefirst half of 2026 and 2025, our AIPR&D included$21.9 million and$22.0 million, respectively, related to
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In thefirst quarter of 2026, our net product revenues increased by$226.7 million, or 8%, as compared to thefirst quarter
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In thesecond quarter and first half of 2026, our net product revenues increased 13% and 11%, as compared to thesecond
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of 2025, primarily due tocontinued performance of our CF therapies and growth from diversification into additional disease
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quarter and first half of 2025, respectively, primarily due tocontinued performance of our CF therapies and growth from
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Other revenues were$10.0 million in thefirst quarter of 2025, related to an upfront payment received from our
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In the second quarter of 2025, our other revenues included a $20.6 million upfront payment received from our
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contributions from CASGEVY and JOURNAVX. In thefirst quarter of 2026, our ex-U.S. total revenues increased 9%, as
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In thesecond quarter and first half of 2026, our U.S. total revenues increased 11% and 9%, as compared to thesecond
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continued strong patient demand, including from new initiations of ALYFTREK, and higher realized net prices in CF, and
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of ALYFTREK, and higher realized net prices in CF, and contributions from CASGEVY and JOURNAVX.
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In thefirst quarter of 2026, our U.S. total revenues increased 7%, as compared to thefirst quarter of 2025, due to
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In thesecond quarter and first half of 2026, our ex-U.S. total revenues increased 14% and 12%, as compared to the
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ALYFTREK uptake, increased CASGEVY product revenues, and a favorable impact from foreign exchange.
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including ALYFTREK uptake, increased CASGEVY product revenues, and favorable impacts from foreign exchange.
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Our cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of
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Our cost of sales primarily cons ists of third-party royalties payable on net sales of our CF products as well as the cost of
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producing inventories. Our cost of sales as a percentage of our net product revenues was 13.2% in each of thefirst quarters of
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producing inventories. Our cost of sales as a percentage of our net product revenues increased to 14.7% and 14.0% in the
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2026 and 2025, as a result of a lower overall royalty rate for our CF medicines, offset by changes in product mix.
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2025, respectively, as a result of changes in product mix, partially offset by a lower blended royalty rate for our CF
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Our research expenses include investment in our pipeline, including our cell and genetic therapy capabilities, which has
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Our research expenses include investment in our pipeline, including our cell and genetic therapy capabilities. We expect
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We expect to continue to invest in our research programs with a focus on creating transformative medicines for serious
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to continue to invest in our research programs with a focus on creating transformative medicines for serious diseases.
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our pipeline going forward. Our outsourced services and other direct expenses were lower as compared to the first quarter of
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our pipeline going forward. Our outsourced services and other direct expenses were lower as compared to thefirst half of
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investments and net foreign currency exchange gains and losses
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thecontinued performance of our CF therapies.
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with common stock withheld for employee tax obligations.