Analyst Conference Summary

Biotechnology

conference date: November 4, 2024 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2024 (third quarter, Q3 2024)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $ billion, down % sequentially from $2.65 billion, and up % from $ billion in the year-earlier quarter.

Net income was $ billion, up sequentially from negative $3.51 billion and down from $ billion year-earlier.

Diluted Earnings Per Share (EPS) were $, down sequentially from negative $13.92 and down from $ year-earlier.

Guidance:

Conference Highlights:

Reshma Kewalramani, CEO, said ""

Vertex acquired Alpine Immune Services for approximately $4.9 billion in cash. Alpine's povetacicept is a highly potent and effective dual antagonist of BAFF (B cell activating factor) and APRIL (a proliferation-inducing ligand). Ready for Phase 3 trial of povetaciceopt for IgAN autoimmune kidney disease. But revenue from that would be in 2028.

In Q1 2024 Vanzacaftor triple combo CF therapy three Phase 3 studies were reported as positive for cystic fibrosis. The NDA to the FDA and MAA to the EMA were filed in Q2 2024. PDUFA January 2, 2025. If approved will have a substantially lower royalty burden than current therapies.

VX-548 for acute pain (now suzetrigine) NDA was accepted by the FDA on July 30, 2024. The Phase 2 trial in peripheral neuropathic pain announced positive results in Q4 2023, with Phase 3 trial to begin in 2H 2024. Already making commercial plans. In Q3 2024 started a Phase 3 trial in diabetic peripheral neuropathy. Believes addresses a multi-billion dollar market.

Work continues on VX-880 and VX-264 for Type 1 diabetes, with the first VX-264 patient dosed. VX-880 presented updated positive Phase 1/2 data in Q2 2024. VS-880 trial resumed in Q2 2024, expanding to 37 patients, and is fully enrolled, positive data presented a ADA.

Povetacicept (IgAN) Phase 3 study will initiate in Q3 2024.

VX-522, a CFTR mRNA therapy multiple ascending dose portion of Phase 1/2 is underway. Expects top line data in H1 2025. Partnered with Moderna. For about 5,000 CF patients who cannot benefit from CFTR modulators.

VX 993, the next generation Nav1.8 pain inhibitor, is in Phase 1 with an IV formulation, but will initiate a Phase 2 oral study in Q3 2024.

But Vertex decided to discontinue development of VX-634 and VX-668 for AATD.

Non-GAAP results: Net income $ billion, up sequentially from negative $3.31 billion, and down from $ billion year-earlier. EPS $, up sequentially from negative $12.83, and down from from $ year-earlier.

I did not see or hear a breakdown of revenue for Syhmdeko, Orkambi, or Kalydeco. Lumped them into Other CF.

See also the Vertex Pharmaceuticals Pipeline page.

Cash and equivalents balance ended at $ billion, down sequentially from $10.2. No debt.

Cost of sales was $ million. Research and development expense was $ million. Sales, general and administrative expenses were $ million. Acquired in-process R&D $ billion; Change in contingent consideration $0 million. Total costs and expenses were $ billion, leaving operating income of $ billion. Interest income net $ million. Other expense $ million. Income taxes $ million.

Q&A selective summary:

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