Strong Q1 Revenue Growth
Total product revenue of $2.99 billion in Q1 2026, up 8% year-over-year; non-GAAP operating income of $1.31 billion (vs. $1.18 billion prior year); non-GAAP net income of $1.1 billion and EPS of $4.47 (up from $4.06).
AlifTrack Commercial Momentum
AlifTrack surpassed $1 billion in cumulative global revenue since U.S. approval (Dec 2024) and EU (Jul 2025); contributed to CF revenue growth of 6% year-over-year and global product growth; label expansions broaden eligibility to ~95% of people with CF and add ~800 newly eligible U.S. patients.
Povitacicept (Povi) Phase III Interim Win in IgAN
RAINIER interim analysis showed 52% reduction from baseline in proteinuria (49.8% vs placebo); 77.4% reduction in serum GdIgA1 (79.3% vs placebo); 85.1% hematuria resolution in treated patients (61.7% vs placebo); 42.2% achieved 24-hour UPCR <0.5 g/g. Safety profile favorable (SAE infection rate 0.5% in both arms), ADAs observed with no impact. BLA submitted 27 days after database lock — fastest submission in company history.
New Disease Areas Driving Growth
Products from new disease areas (KASJEVY and GERNAVICS) accounted for approximately 25% of total product revenue growth in Q1 2026; KASJEVY generated $43 million and GERNAVICS $29 million in Q1 sales.
KASJEVY Launch Progress
Over 500 patients have initiated their KASJEVY treatment journey; hundreds have had first cell collection and many are ready for infusion; established reimbursement progress including a pricing agreement in Germany; company expects KASJEVY to contribute meaningfully toward >$500M non-CF revenue goal for 2026 and to have multibillion-dollar potential long term.
GERNAVICS Uptake and Access Expansion
Over 1 million Gernavix prescriptions written since launch; >350,000 prescriptions filled in the quarter; Q1 revenue $29 million; payer coverage expanded to 240 million lives including first of the big four Medicare Part D plans effective May 1; field force doubled to 300 reps to drive adoption and expected to more than triple prescriptions in 2026.
CF R&D and Label Expansion Milestones
Label expansions for AlifTrack and TRIKAFTA now cover patients with at least one CFTR-responsive variant (in vitro or clinical) increasing eligibility to ~95% of people with CF; submissions planned for AlifTrack in ages 2–5 (pivotal trial showed 65% of children reached normal CFTR function) and TRIKAFTA in ages 1–2; next-gen 3.0 CFTR VX-828 patient study on track with results expected H2 2026; VX-581 and VX-2272 in Phase I.
Balance Sheet and Capital Allocation
Ended quarter with $13 billion in cash and investments; deployed ~$344 million to repurchase >741,000 shares in Q1, reflecting continued shareholder returns while prioritizing investment in innovation.
Pipeline Advancement Beyond Renal
Phase II proof-of-concept study of Povi in generalized myasthenia gravis underway; enrollment completed in Phase II portion of Povi primary membranous nephropathy study and Phase III portion initiated ahead of prior guidance; enaxaplin AMPLIFIED enrollment completed with readout expected H2 2026; zamylosel dosing resumed in Type 1 diabetes study after manufacturing pause with prior landmark results (10 of 12 insulin-free among full-dose patients with ≥1 year follow-up).
Reiterated 2026 Guidance and Margins
Reiterated full-year 2026 revenue guidance of $12.95B–$13.10B (8%–9% growth); expect >$500M revenue from non-CF products in 2026; full-year gross margin expected just under 86%; combined non-GAAP operating expense guidance $5.65B–$5.75B; non-GAAP tax rate guidance 19.5%–20.5%.