Coming off of a strong third quarter, Vertex Pharmaceuticals is nearing several important milestones, including the potential approvals of vanzacaftor triple in cystic fibrosis and the non-opioid therapy suzetrigine in pain—both slated for January 2025.
Vertex Pharmaceuticals continued its robust quarterly performance, surpassing analysts’ expectations in both the top line and bottom line in the third quarter, driven by strong demand for its cystic fibrosis therapy Trikafta.
The biotech on Monday reported $2.77 billion in Q3 revenue, 12% year-on-year growth which was 4% ahead of the consensus estimate of nearly $2.68 billion. Vertex’s net income in the quarter of more than $1.14 billion was 9% higher than analyst projections, while non-GAAP earnings-per-share of $4.38 surpassed the consensus of $4.08 per share by 7%.
Vertex in its Q3 announcement attributed its earnings beat to the “continued strong performance” of its cystic fibrosis (CF) therapy Trikafta, sales of which comprised majority of the biotech’s revenue in the quarter. Trikafta brought in $2.59 billion in the quarter, delivering a 3% consensus beat.
While Vertex did not provide a dedicated Q3 line item for the sales of its gene therapy Casgevy, the company announced that it has dosed its first patient and that this is reflected in its product revenue. Casgevy has a list price of $2.2 million.
Jefferies analyst Michael Yee in a note to investors called Vertex’s Q3 performance “expected” while noting that it “speaks to solid execution which investors have appreciated.”
Reflecting the strong earnings in the quarter, Vertex raised its full-year product revenue guidance to between $10.8 billion and $10.9 billion, up from the previous forecast range of $10.65 billion to $10.85 billion.
BMO Capital Markets analyst Evan Seigerman said in an investor note that “the CF opportunity continues to be foundational for pipeline expansion and that there is room for share upside,” adding that the biotech’s pain pipeline is also “encouraging” and gives his firm more confidence in the company’s earlier-stage assets.
These pipeline plans dominated the company’s investor call on Monday, with CEO Reshma Kewalramani announcing that the regulatory review for its next-generation CF therapy vanzacaftor triple is “underway,” with an FDA target action date of Jan. 2, 2025. In February 2024, Vertex released strong pivotal Phase III data for the investigational therapy, demonstrating that it could match or was better than Trikafta in patients aged six years and older.
Stifel analyst Paul Matteis said in an investor note that vanzacaftor triple’s late-stage data “largely derisk approval,” though its commercial success remains to be seen, particularly its meaningful differentiation versus Trikafta. Vertex is currently trialing vanzacaftor triple in children aged two to five years. The biotech is also developing an mRNA-based therapy for CF in partnership with Moderna.
Beyond CF, Vertex is also quickly approaching a regulatory milestone for its pain portfolio, with the FDA due to release its verdict on the non-opioid pain drug suzetrigine on Jan. 30, 2025. Phase III data last month showed strong relief in patients undergoing abdominoplasty and bunionectomy, with a relatively clean safety profile.
According to Matteis, however, the “next big binary catalyst” for Vertex—particularly its pain program— is the Phase II readout for VX-993 in lumbosacral radiculopathy, which is due by the end of the year.
Still, Stifel remains cautiously optimistic about Vertex’s prospects in pain, given that this space is a “notoriously challenging indication with small effect sizes,” Matteis wrote.
