Krystal Biotech, Inc.

Thank you for standing by and welcome to Crystal Biotech's third quarter earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentations, there will be a question and answer session. During the question and answer sessions, there will be a limit of two questions per participant. As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stéphane Pequette. Vice President of Corporate Development. Please begin.

Good morning, and thank you all for joining today's call. Earlier today, we released our financial results for the third quarter of 2024. The press release is available on our website at www.crystalbio.com. We also filed our earnings 8K and 10Q with the SEC earlier today. Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer, Suma Krishnan, President of Research and Development, Jennifer McDonough, Senior Vice President of Patient Access, Analytics, and Operations, Christine Wilson, Senior Vice President and Head of US Sales and Marketing, and Kate Romano, Chief Accounting Officer. This conference call will, and our responses to questions may, contain forward-looking statements. You are cautioned not to rely on these forward-looking statements which are based on current expectations using the information available as of the date of this call and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected. A description of these risks, uncertainties, and other factors can be found in our SEC filings. With that, I will turn the call over to Krish.

Thank you, Stephan. Good morning and welcome to the call. Look, as I mentioned in my PR attribution, we're well on our way to achieving the two year target that we set at the time of the launch. And by comparison to any other launch in orphan diseases or genetic therapies, we believe our launch has exceeded all expectations to date. In my mind, there are two primary drivers for this success. The first obviously being the drug itself with all its attributes of efficacy, safety, patient convenience, et cetera, and the second being our assiduous focus on patient and physician experience. We have allowed the physician and the patient to drive demand at a pace they're comfortable with, and it's been rewarding, especially in an indication where the expectation is that they will be on drugs for a long time. On top of that, global opportunities for Vizuvac come into focus. Ophthalmic formulation is progressing towards a registrational study in the next few months. And so, we're starting to see increasing upside in the total market opportunity for the Visevic franchise overall as we work toward treating death patients globally and comprehensively. In Europe, we're presently on track for a CHMP opinion before year-end, and our recent breakthrough with HAS, granting early reimbursed taxes in France, reflects a significant demand for Vajavec in Europe. And with our JNDA submitted last month, we're also on track for a 2025 launch in Japan. And so all preparations are underway for launch in EU4, UK, and Japan, sequentially next year. Meanwhile, we had a positive readout for Jun aesthetics, KB301 and Q3, where we saw clear efficacy signals. And that propels us forward to a phase two study expected to start next year and also continue to work on the Jun aesthetics pipeline. That was the first of many data readouts upcoming from our deep clinical stage pipeline. We're looking forward to reporting on two more programs before year end, including our first data on HSV1-based gene delivery to the lung, a tissue that has to date been hard to reach with other approaches. So both on the commercial and clinical fronts, we're excited and look forward to the rest of 2024 and 2025. Finally, I'm happy to report that Crystal was again profitable this quarter at 95 cents per share, up sequentially from 54 cents per share in the second quarter of 2024. In Q3, we accrued $12.5 million in litigation expenses that once again mitigated our EPS as it did in our two prior quarters. This is the final accrual related to the litigation expense, and there will be no additional litigation accruals moving forward. With increasing profitability, a strong balance sheet, and upcoming expansion of our VizuVec franchise, both in the U.S. and through ex-U.S. launches, and our iDraw formulation, we're super stoked about both the near-term and the long-term outlook for Crystal. Moving now to our results. Net Vyzovac revenue for the Q came in at $83.8 million, while gross margins and GTN continue to behave as expected. Thanks to the strong growth we achieved this quarter, total net Vyzovac revenue since launch in August 2023 has already surpassed $250 million. Achieving this milestone, only a little over a year after our first sale, is a tremendous achievement for our organization and a testament to the value Visevic is providing to patients suffering from DEB. Also, please note that net Visevic revenue reported today again includes an accrual for patients on contracted commercial plans who are projected to potentially hit the cap of $900,000 gross per patient per calendar year in 2024. With that, I'll hand it off to Jen and Christine to share more detail on our recent accomplishments and strong fundamentals which we expect will sustain our launch for years to come. Jen?