VERTEX PHARMACEUTICALS INC / MA (VRTX) Company Report

Clinical pipeline: Phase 3 trials in diabetic peripheral neuropathy (DPN) enrolling two studies on track for completion in 2026, targeting ~2 million U.S. DPN patients; pipeline includes approved NaV1.8 inhibitor suzetrigine and preclinical NaV1.7 program.
Renal franchise: Alpine acquisition closed ~18 months ago with rapid integration; RAINIER trial for povetacicept enrolling quickly, interim analysis and rolling submission planned; programs in IgAN, PMN, warm AI hemolytic anemia, and GMG.
Commercial performance: $500 million revenue reported for vanzacaftor/tezacaftor/deutivacaftor in first nine months, with six-month liver monitoring label requirement; Casgevy on track for >$100 million in 2025 revenue with broad access in U.S., Middle East, and Europe.
Capital allocation: Repurchased $2 billion of shares in 2025; maintains flexibility for high-science BD and internal investment; Alpine deal cited as ideal size and stage.

1 day ago

Transcript

Vertex discusses FY 2025 pipeline and commercial updates

VRTX

Diabetic peripheral neuropathy (DPN) Phase 3 enrollment is on track to complete in 2026, targeting 2 million U.S. patients with high unmet need.
ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) achieved $500 million in revenues in its first nine months, with steady uptake among naïve and TRIKAFTA-experienced patients and strong FEV₁ and sweat chloride improvements.
Renal portfolio expansion: POVI engineered for optimal potency, affinity and tissue distribution; poised for monthly subcutaneous auto-injector launch; exploring indications in IgA nephropathy, membranous nephropathy, warm autoimmune hemolytic anemia, GMG and Sjögren’s.
APOL1-mediated kidney disease Phase 3 interim cohort enrolled; interim data showed a 47.6% proteinuria reduction at 13 weeks in FSGS patients; full readout expected late 2026.
Casgevy CAR-T ramp: projected >$100 million revenue in 2025; broad access and reimbursement in the U.S., Middle East and Europe; growing patient funnel for 2026 infusions.

1 day ago

Transcript

Vertex reviews CF product launches and late-stage pipeline at UBS Healthcare Conference 2025

VRTX

Product Launch

Alyftrek CFTR modulator uptake strongest in treatment-naïve and new-mutation CF patients; U.S. approval in December 2024, EU approval in late 2025, with unchanged monthly-to-annual liver monitoring ex-U.S.
Povetacicept (Tovy) in IgA nephropathy: Phase III enrollment of >600 patients complete, breakthrough designation secured, rolling BLA to use priority review voucher, with data expected in H1 2026
Enaxaplin (VX-147) for APOL1-mediated kidney disease: interim Phase III cohort enrolled under FDA accelerated approval agreement; top-line readout anticipated in 2026
Suzetrigine acute pain launch: surpassed 300,000 scripts by mid-October 2025; coverage for 170 million lives secured across major PBMs and government plans; patient support program ensures no-cost access pre-reimbursement
Allogeneic stem cell therapy for Type 1 diabetes: pivotal Phase III enrollment complete, dosing paused pending manufacturing analysis, with results to preserve trial integrity

Nov 11, 2025, 3:15 PM

Transcript

Editas Medicine reports Q3 2025 results and business updates

VRTX

Earnings

Guidance Update

New Projects/Investments

Editas presented in vivo preclinical proof-of-concept data showing >90% LDL-C reduction in non-human primates within 48 hours of a single EDIT-401 dose; the company plans to file an IND/CTA by mid-2026 and target initial human PoC by year-end 2026.
Cash, cash equivalents, and marketable securities totaled $165.6 M as of September 30, 2025, and with $17.3 M of subsequent ATM proceeds, the runway is extended into Q3 2027.
For Q3 2025, net loss was $25.1 M (-$0.28 per share) versus $62.1 M (-$0.75) in Q3 2024; collaboration and other R&D revenues rose to $7.5 M from $0.1 M, R&D expenses fell to $19.8 M from $47.6 M, and G&A expenses declined to $12.3 M from $18.1 M**.
Editas raised $17.8 M of gross equity proceeds from its ATM facility during Q3 2025 and remains on track for disciplined spending and pipeline advancement.

Nov 10, 2025, 12:00 PM

Press Release

CRISPR Therapeutics reports positive Phase 1 CTX310 data

VRTX

Single-course IV CTX310 achieved dose-dependent, durable ANGPTL3 editing with a mean reduction of –73% (max –89%), driving mean –55% triglycerides and –49% LDL at Day 60 at the highest dose.
In participants with baseline triglycerides >150 mg/dL, CTX310 delivered a 60% mean TG reduction at therapeutic dose levels.
The therapy was generally well tolerated in 15 participants (0.1–0.8 mg/kg), with no treatment-related serious adverse events or ≥Grade 3 liver transaminase elevations.
CRISPR is advancing CTX310 into Phase 1b trials in severe hypertriglyceridemia and mixed dyslipidemia to further assess safety and efficacy.

Nov 8, 2025, 2:56 PM

Press Release

Vertex reports Q3 2025 financial results

VRTX

Earnings

Guidance Update

Product Launch

Revenue rose 11% year-over-year to $3.08 billion, driven by cystic fibrosis therapies and new product contributions of $17 million from KASJEVY and $20 million from Genavix.
Combined non-GAAP R&D, acquired IPR&D and SG&A expenses increased 19% to $1.28 billion, reflecting accelerated povitacicept (PoV) renal programs and Genavix commercial investment; non-GAAP operating income was $1.38 billion.
Non-GAAP EPS was $4.80 (up 10%), and the company held $12 billion in cash and investments at quarter-end, deploying $1.1 billion for share repurchases (2.7 million shares) in Q3.
2025 guidance updated to $11.85–$12.00 billion in total revenue (8–9% growth), $5.0–$5.1 billion in operating expenses, and a lowered non-GAAP tax rate of 17–18%.
Commercial and pipeline progress includes ElefTrek launches in Europe, Genavix coverage for 170 million lives with over 300,000 prescriptions filled, initiation of CF next-gen corrector VX-828, and pivotal-stage renal programs for PoV in IgA nephropathy and membranous nephropathy.

Nov 3, 2025, 9:30 PM

Transcript

Vertex reports Q3 2025 results

VRTX

Earnings

Guidance Update

Product Launch

Q3 revenue of $3.08 B, up 11% Y/Y, and full-year guidance refined to $11.9–12.0 B
Completed TRIKAFTA pivotal study in 1–2-year-olds with a –71.8 mmol/L sweat chloride reduction; ALYFTREK now approved in US, UK, EU, Canada, New Zealand, and Switzerland
Povetacicept IgAN RAINIER Phase 3 fully enrolled; rolling BLA submission to begin by YE 2025 and complete in H1 2026; Inaxaplin AMKD Phase 3 IA cohort enrollment complete, AMPLIFIED on track to finish by YE 2025
CASGEVY momentum builds with expected >$100 M in FY 2025 revenue and rising patient initiations and cell collections YTD

Nov 3, 2025, 9:30 PM

Presentation

Vertex reports Q3 2025 financial results

VRTX

Earnings

Guidance Update

Total revenue of $3.08 billion, up 11% year-over-year; U.S. revenue grew 15% to $1.98 billion, international revenue rose 4% to $1.10 billion.
GAAP net income of $1.1 billion and non-GAAP net income of $1.2 billion, compared with $1.0 billion and $1.1 billion in Q3 2024.
Refined full-year 2025 guidance: total revenue now expected at $11.9–$12.0 billion; combined non-GAAP R&D, AIPR&D, and SG&A expense at $5.0–$5.1 billion.
Cash, cash equivalents, and marketable securities totaled $12.0 billion as of September 30, 2025, up from $11.2 billion at December 31, 2024.
R&D pipeline milestones achieved: pivotal enrollment complete in the Phase 3 povetacicept IgAN trial, with the first BLA module on track for FDA submission by year-end 2025.

Nov 3, 2025, 9:06 PM

8-K

CervoMed appoints David Quigley to Board

VRTX

Board Change

CervoMed Inc. appointed David Quigley, former Senior Partner at McKinsey & Company who led its Private Capital and Life Sciences practices, to its Board of Directors.
The appointment aligns with CervoMed’s preparation for FDA feedback on its Phase 3 trial design in Q4 2025.
CervoMed recently completed a successful Phase 2b RewinD-LB trial and plans to initiate a global Phase 3 trial in mid-2026.
Quigley’s strategic and commercial expertise is expected to support neflamapimod’s pipeline advancement, partnering, and M&A initiatives.

Oct 28, 2025, 12:00 PM

Press Release

Vertex outlines diversified commercial launches and pipeline catalysts

VRTX

Product Launch

M&A

Vertex has three ongoing commercial launches—LifTrak (CF), Casgevy (sickle cell disease/beta thalassemia), and Jurnavix (acute pain)—as part of its revenue diversification strategy.
The pipeline includes four Phase 3 programs for diabetic peripheral neuropathy, IgA nephropathy, APOL1-mediated kidney disease, plus a Phase 3 for primary membranous nephropathy soon to start, and a Zomylacell cell therapy in Type 1 diabetes.
For POVI in IgA nephropathy, Vertex plans to complete full-cohort enrollment by the end of 2025, with top-line data expected in H1 2026.
Jurnavix has secured access to 150 million covered lives in the U.S.—85 million unrestricted—and achieves a 14-day average script duration, with 65% of prescriptions filled at discharge.
Through the Alpine acquisition, Vertex gained POVI, a dual BAF/APRIL inhibitor delivered via a monthly autoinjector, targeting a patient population of 300k+ in the U.S./EU and >1 million globally.

Sep 23, 2025, 7:10 AM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for VERTEX PHARMACEUTICALS INC / MA.

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