Q2 2026 Celcuity Inc. Earnings Call Transcript
Key Points
- FDA approval of REVTORPYK for HR-positive, HER2-negative advanced breast cancer without PIK3CA mutation, with shipments expected to begin late Q3 2026.
- Positive Phase 3 VIKTORIA-1 results in PIK3CA mutant cohort, showing median PFS of 11.1 months vs 5.6 months for alpelisib, with a hazard ratio of 0.5.
- NCCN guidelines updated to recommend REVTORPYK triplet and doublet as preferred Category 1 regimens for second-line treatment.
- Expansion of VIKTORIA-2 trial to include endocrine-sensitive patients, potentially broadening first-line treatment opportunities.
- Strong cash position of $754 million, expected to fund operations into 2029, supporting ongoing development and commercial launch.
- Net loss increased to $78.9 million in Q2 2026, up from $45.3 million in the prior-year period, driven by higher SG&A expenses.
- Commercial launch is dependent on FDA approval for a second manufacturing site, with no guaranteed timeline for review.
- Gross-to-net discount of approximately 20% from WAC, which may impact revenue expectations.
- Limited real-time visibility into prescription data due to buy-and-bill model, making it difficult to track launch progress accurately.
- Potential delays in sNDA submission for PIK3CA mutant cohort, with review timelines of 6-10 months, delaying label expansion.
Good afternoon, ladies and gentlemen. Welcome to Celcuity's second-quarter 2026 financial results conference call and webcast. (Operator Instructions)
I would now like to turn the conference over to Jodi Sievers, Corporate Communications and Investor Relations at Celcuity. Please go ahead.
Thank you, [Ludy], and good afternoon to everyone. Thank you for joining us today to review Celcuityâs second-quarter 2026 financial results and business update.
Earlier today, Celcuity released financial results for the quarter ended June 30, 2026. The press release can be found on the Investors section of Celcuityâs website. Joining me on the call today are Brian Sullivan, Celcuityâs Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer; and Eldon Mayer, Chief Commercial Officer, who will be available during Q&A.
As we begin, I would like to remind listeners that our comments today
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