Analyst Conference Summary

Biotechnology

conference date: November 3, 2025 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2025 (third quarter, Q3 2025)

Forward-looking statements

Overview: Strong revenue growth.

Basic data (GAAP):

Revenue was $3.08 billion, up 4% sequentially from $2.96 billion, and up 11% from $2.77 billion in the year-earlier quarter.

Net income was $1.08 billion, up 5% sequentially from $1.03 million and up 3% from $1.05 billion year-earlier.

Diluted Earnings Per Share (EPS) were $4.20, up 5% sequentially from $3.99 and up 5% from $4.01 year-earlier.

Guidance:

Slightly increased the bottom end of 2025 revenue guidance to between $11.9 and $12.0 billion. But also increased expense estimates. Lowered non-GAAP tax rate estimate.

Conference Highlights:

Reshma Kewalramani, CEO, said "Vertex delivered strong results across the board in the third quarter, extending our leadership in CF (cystic fibrosis), continuing to build global momentum for Casgevy, and advancing the launch of Journavx in acute pain. We also delivered strong progress across the R&D pipeline, with completion of enrollment in the Phase 3 study of povetacicept in IgAN, initiation of the Phase 2/3 study of povetacicept in primary membranous nephropathy, as well as advancement of several programs in research and earlier-stage clinical development. For the remainder of 2025, we are focused on executing the ongoing launches, initiating the povetacicept BLA submission in IgAN for potential U.S. accelerated approval, advancing the pipeline, and preparing for new launches in additional disease areas."

In Q3 2025 the VX-522 Phase 1/2 trial was approved to resume dosing, and did so.

Journavx (Suzetrigine) for acute pain was approved by the FDA in Q1. By mid-October 2025 more than 300,000 presciptions had been filled. Two Phase 4 trials were completed by October 2025. Continues to aid payer coverage, including Medicaid in 19 states; working on Medicare. Suzetrigine for DPN Phase 3 trial should begin in November 2025.

In Type 1 diabetes, in Q3 2025 completed enrollment in the Phase 1/2/3 study of zimislecel. Vertex has temporarily postponed completion of dosing in the study, pending an internal manufacturing analysis.

Vertex does not expect to see any signifant effects from tariffs in 2025.

In Q2 2025 Alyftrek for cystic fibrosis was approved by the European Commission. In July by Canada. Reviews are underway in Switzerland, Australia, and New Zealend.

In Q3 2025 Casgevy ofr sickle cell disease and transfusion dependent beta thalassemia won reimbursement in Italy. So far about 165 patients have recieved the gene therapy.In Q2 2025 Vertex completed enrollment of children 5 to 11 years old with SCD or TDT in two global Phase 3 studies of Casgevy. On track to complete dosing in the second half of 2025.

Ximislecel for type 1 diabetes is now in a Phase 3 trial.

Trials are underway in Povetacicept for IgAN, pMN (membranous nephropathy), AMKD, and DM1. The FDA granted Breakthrough Therapy Designation in Q3 for IgAN, Phase 3 enrollment completed in Q4, and a rolling submission should begin by year end. A Phase 2/3 study was started for pMN, which now has Fast Track designation. An oral presentation will be made on November 8, 2025 at ASN. Believes should be best in class.

VX-828 combo for CF preclinical work shows it could be the best CF therapy ever. Phase 1 trial first cohort being treated in Q3 2025.

VX-407 for ADPKD (kidney with mutant PKD1 genes) completed the Phase 1 trial in healthy volunteers in Q1 2025. A Phase 2 study should start in Q3 2025.

Non-GAAP results: Net income $1.2 billion, up % sequentially from $na billion, and up 9% from $1.1 billion year-earlier. EPS $4.80, up 6% sequentially from $4.52, and up 10% from from $4.38 year-earlier.

No breakdown of revenue for Casgevy, Journavx, Syhmdeko, Orkambi, or Kalydeco. Lumped them into Other.

See also the Vertex Pharmaceuticals Pipeline page.

Cash and equivalents balance ended at $12.0 billion, flat sequentially from $12.0. No debt.

Cost of sales was $415 million. Research and development expense was $978 million. Sales, general and administrative expenses were $445 million. Acquired in-process R&D $55 million; Change in contingent consideration $2 million. Total costs and expenses were $1.89 billion, leaving operating income of $1.19 billion. Interest income net $123 million. Other expense $10 million. Income taxes $216 million.

Q&A selective summary:

Switching and starts, tipping point? Alyftrek, vast majority of new patients are now starting with it. Seeing strong uptake.

Pove? IgAN data we will share next week is very exciting. IgAN is a chronic disease with a bad end, transplant or death. It has a better dosing routine than competitors.

Journavx access? In discussions with the third PBM. We see continued presciption growth while we finalize access.

Capital allocation priorities? No change. Top priority is to reinvest internally. We did more share buybacks in Q3. We saw prices that were quite attractive. For external assets, we are looking for the best, could be preclinical or in the clinic.

No Pain Act? The list was supposed to be out last Friday, but was postponed. We continue to advocate for Journavx. But the principle of the act is important.

Transition of Trikafta to Alyftrek? We expect a majority of patients to transition in the next few years. It is a better drug.

Chronic pain, Journavx or other? No new updates. Focus on getting VPN study up and running. could serve 2 million patients. Looking at Nav 17s and possible combinations with Journavx for chronic pain.

Would you look at bigger BD deals, given your cash position? Our BD is in lockstep with our internal strategy. An external asset would need to fit with all of our criteria that have led us to success. It is not about the size of the deal.

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