11/3/2025

speaker
Krish
President and Chief Executive Officer

a rare genetic disease of the skin that is a strong fit with our HSV-1 gene delivery platform and our commercial footprint. Simmo will share more about this program later on the call. Financially, we're strong and well-positioned to execute on our strategic growth plans and deliver value to shareholders. Moving now to our 3Q results, we are pleased to report another quarter of revenue growth with net Vycevic revenue coming in at $97.8 million. The patient pausing impacts due to summer holidays that we observed earlier last quarter were mitigated by patient ads and early traction in Europe. Net Weisjeweck revenues reported here does include a contribution from Europe following our launch in Germany in late August. This brings total net Weisjeweck revenues since launch to over $623 million. Gross margins were 96% for the quarter. Gross-to-net dynamics were stable as with prior quarters. I'm happy to report continued acceleration in new reimbursement approvals in the US. Our team added over 40 new approvals since our last earnings call update, bringing the total number of reimbursement approvals in the US to over 615. This is now our second sequential quarter of reimbursement approval acceleration and a reflection of our field team's efforts, as well as the ongoing sales force expansion. Our expanded field force is now fully hired and being deployed as training is completed. Full impact is expected in early 2026. We're also happy to report continued expansion of our prescriber work, reflecting increased penetration into the community setting, with the total number of prescribers in the U.S. now exceeding 450. I would like to highlight a recent milestone achieved in the U.S., which was the FDA approval of our updated Vizuvac label. This label update expanded the Vizuvac-eligible patient population to include deaf patients from birth and also provided patients with full flexibility in how they choose to dose Vizuvac. This change reinforces Vizuvac's leadership position as the most flexible and convenient corrective therapy for DEB and should serve as a tailwind for adoption and compliance in the future. Compliance to weekly therapy continued the trend we reported in previous quarters, coming in in the low 80s as more patients achieved durable wound closure and more mild and moderate patients come on to therapy. While the revised label change should have a positive impact to compliance in the future, we, as always, continue to expect some quarter-to-quarter waviness in the U.S. revenues as we build on our long-term growth trajectory. With that, I'll now hand it off to Laurent to share his excitement in Europe. Laurent?

speaker
Laurent
Executive Vice President, Europe

Thank you, Krish. It is my pleasure to share an update on our progress in Europe. Our first European launch in Germany is off to a good start. Since launching in late August, we have seen widespread interest and demand across the country. Based on available aggregate level data, we estimate the number of patients prescribed by Juvec in Germany to be approximately 20. Just as importantly, we are seeing broad prescribing patterns across the country with prescriptions from over 10 centers today. This breadth of prescribing is particularly helpful given the requirement for patients to start therapy in a healthcare setting. By growing the number of centers prescribing Vajruvec, we can help patients to start therapy closer to home and avoid potential single-center patient visit bottlenecks. Based on current trends, we expect continued steady growth in patients' inclusion in the months ahead. We are also making rapid progress outside of Germany. In September, the Haute Autorité de Santé, also known as HAS, the French HDA body, approved early Vajurek access under the post-marketing authorization Accès Précoce 2. And last month, we formally launched Vajurek in France. Importantly, the relevant authorities in France are also allowing Vijuvec to be dispensed outside the hospital setting. This is the first time a gene therapy has been approved in such a setting in France, a tremendous milestone to our local team and patients across the country. Last month, HAS also appraised Vijuvec under the Amélioration du Service Médical Rendu, or ASMR, classification system, A key initial step for pricing and reimbursement discussions in France. Vajuvec received an ISMR3 designation. This designation, which was only granted to 11% of the new drugs reviewed in 2024, acknowledged the added clinical benefit of Vajuvec and may open up the possibility for EU parity list pricing in France. Finally, I'm also proud to report that VIJUVEC was granted the Prix Gallien in Italy under the Advanced Therapy Medicinal Product category, a prestigious award recognizing excellence in scientific innovation to improve the state of human health. This award is an important acknowledgement of the innovative and transformational nature of VIJUVEC and a helpful touchpoint as we start to engage with the relevant stakeholders in Italy. With these recent achievements, we are excited about the long-term growth trajectory in Europe and maximizing Vijovec access to the thousands of dead patients in the region. I now hand the call back over to Krish.

speaker
Krish
President and Chief Executive Officer

Thanks, Laurent. As I mentioned before, we have now also launched Vijovec in Japan. This summer, We were approved by the MHLW for the treatment of patients, and late last month, we successfully completed pricing negotiations with the Japanese authorities and launched Vizivac. We're very pleased with our pricing in Japan, and that is a testament to the clinical benefits achieved by deaf patients treated with Vizivac. Our core Japanese team has been in place for over a year and is now fully staffed to support the Vajavec launch. Our Japanese medical team has also been active for over a year, mapping key centers and patients, which will be the early focus of our launch. Although we expect contribution from Japan in 2025 to be modest, it will be another important revenue growth driver in 2026. Finally, I wanted to highlight one more contributor to the long-term growth of Vizuvac. In addition to our direct Vizuvac launches in the U.S., major European markets, and Japan, we've started contracting with regional specialty distributors to support the commercialization of Vizuvac in rest of the world markets. We have executed agreements in place with multiple leading distributors covering key markets in Central and Eastern Europe, Turkey, and the Middle East, and expect to add more in the year ahead. Healthcare infrastructure and access vary significantly across rest of the world markets, but even after accounting for this variability, we estimate that a global distributor partner network could help bring Vizuvac to thousands more deaf patients around the world and supplement our exciting growth strategy in the United States, Europe, and Japan. With that, I'll now hand it off to Suma to touch on recent pipeline progress. Suma?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-