Travere Therapeutics, Inc.

Good evening, ladies and gentlemen, and welcome to the Verica Pharmaceuticals First Quarter 2025 Corporate Update Conference Call. At this time, all participants are in a listen-only mode. After the speaker's remarks, there will be a question and answer session. As a reminder, this conference is being recorded. I will now turn the call over to our host, Kevin Gardner of LifeSci Advisors. You may begin your conference.

Thank you, Operator. Hello, everyone, and welcome to Verica Pharmaceuticals' first quarter 2025 Corporate Update Conference Call. With me on the line this evening are Jason Rieger, President and Chief Executive Officer of Verica Pharmaceuticals, Noah Rosenberg, Chief Medical Officer, John Kirby, Interim Chief Financial Officer, and David Zawitz, Chief Operating Officer. As a reminder during today's call, management will make forward-looking statements. These statements may include expectations related to the commercialization of WICAN for the treatment of molluscum contagiosum in the United States, continued revenue growth, regulatory developments, the development of Verica's product candidates, the company's expected cash runway, and its ability to obtain funding for future operations. and Verica's overall business strategy and planned operations. These forward-looking statements are based on the company's current expectations and involve inherent risks and uncertainties. And based on those risks and uncertainties, Verica's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements. Please see Verica's SEC filings for important risk factors. Verica cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in expectations. In addition, during today's call, management will discuss certain non-GAAP financial measures. These non-GAAP financial measures are in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with GAAP. There are a number of limitations related to the use of these non-GAAP financial measures versus their closest GAAP equivalents. The earnings release that the company issued today includes GAAP to non-GAAP reconciliations for these measures, and is also available on the investor relations section of Verica's website. I'll now turn the call over to Verica's president and CEO, Jason Rieger.

Thank you, Kevin, and good evening, everyone, and thank you for joining us for our first quarter 2025 corporate update call. I'm pleased to report that our focused commercialization strategy is helping to drive increased demand for YCAMP. On April 7th, we pre-announced strong sequential growth in the first quarter, with WICAN's dispensed applicator units increasing 16.7% over the fourth quarter of 2024 and rising above 10,000 units per quarter for the first time since the launch of the product. As announced today, this also resulted in $3.4 million in revenue for the quarter. I'm further excited to say that we have seen momentum build throughout Q1 and are working to continue to capture that momentum. As demand for Y-CAMs by pediatricians, dermatologists, and other healthcare professionals and their patients continues to grow, we believe Y-CAMs distributor inventory levels have normalized, and we expect that dispensed applicator units will now more closely track to our revenues. Importantly, we are executing on our commercial strategy as a much leaner and more capital-efficient company, which I believe will place us on a strong and sustainable growth trajectory. In parallel with our commercial progress, Verica's clinical stage pipeline also continues to advance. We continue to work with our development and commercialization partner, Torrey Pharmaceutical, to initiate our Phase III program of Y-CAN for the treatment of common warts. Meanwhile, we continue to advance our novel oncolytic peptide, BP315, which has shown promising safety and efficacy data in Phase II trials for the treatment of basal cell carcinoma, having recently held an end-of-Phase II meeting with the FDA to discuss the design of our Phase III program. Given the significant unmet need for both of these indications, we believe developing these programs has the potential to significantly grow the value of our company. I will now provide a more detailed update on our commercial activities for Wycant. During the first quarter of 2025, the full effects from our revised commercialization strategy, which we began to implement in Q4 of last year, helped drive demand for Wycant. As we have previously noted, we initially focused on territories with high prevalence of molluscum and established strong insurance coverage. The productivity of our sales force also improved substantially during the first quarter. Our average dispensed applicator unit per selling day continues to trend favorably, giving us additional confidence that our new commercial strategy is working. To that end, we have recruited new sales representatives to work in new territories, splitting certain large markets and entering other new markets to capitalize on improving demand. Throughout the first quarter, we also continued adding local independent regional pharmacies to our strong relationships with our national specialty pharmacy partners. Our approach to distribution of Y-CANs has been to focus where physicians and other healthcare professionals prefer to write prescriptions, and we've seen strong adoption to this approach since the relaunch. As previously noted, Y-CAN inventory levels appear to have normalized. as we are seeing multiple orders each month from our distribution partners rather than larger infrequent stocking orders. Going forward, we believe shipments of Y-CAMP applicator units will more closely reflect the underlying demand from physicians and patients, and that this closer relationship will translate into steadier revenue growth as we continue the relaunch. Finally, our cost-cutting measures have taken hold and our quarterly expenses are reflective of that. we would expect that going forward we will selectively add to sales personnel in geographic areas where we have good coverage but no representative, and add additional sales representatives in markets where there are enough potential customers to warrant multiple representatives in that market. I'd like to now also provide a brief update on our clinical stage pipeline. As previously reported with respect to WICAN, our Japanese development and commercialization partner, Tori Pharmaceutical filed in late 2024 a new drug application in Japan seeking approval of YCAM, designated in Japan as TO208, the treatment of molluscum. With an estimated over 1.6 million patients in Japan alone, molluscum represents a significant market opportunity for YCAM. We look forward to Tori sharing updates on the regulatory approval process later this year. We are also working with Tori to launch a global phase three study evaluating Y-CAMP in the United States for TO208 in Japan for the treatment of common warts. Merica remains eligible to receive a milestone payment of $8 million upon the initiation of this study, which could begin as early as mid-2025. As we previously stated, the cost of this study will be split 50-50 with Tori, but their portion will be paid by Tori and reimbursed by Verica at a future milestones and transfer price payments. Regarding our Phase III-ready clinical oncology asset, BP315, which we are developing for the treatment of basal cell carcinoma, As previously disclosed in January, a post-hoc analysis of data from our Phase 2 or Part 2 of our Phase 2 study demonstrated that treatment with BP315 led to a calculated objective response rate, or OOR, of 97%. OOR was defined as the percentage of study subjects who did not demonstrate disease progression and who experienced at least 30% reduction in tumor size, along with a partial or complete response following treatment. We'll leave positive preliminary top-line results from our Phase II study to suggest that BP315 has the potential to change the treatment paradigm for patients with basal cell carcinoma, the most common form of skin cancer. As noted on our fourth quarter call, we expect to announce additional genomic and immune response data for BP315 in mid-2025. We are also encouraged by our recent end-of-Phase II meeting with the FDA. After reviewing the final meeting minutes and this additional data, we plan on providing a global development program update later this quarter. Finally, I would like to mention recent appointments to our senior management and board of directors. In March, we announced that Dr. Noah Rosenberg joined the Verica team as our new chief medical officer. Noah is a highly accomplished pharmaceutical executive and physician who brings deep expertise in both drug development and commercialization. As CMO, he will play an instrumental role in advancing our goal for YCAM to become the standard of care for the treatment of molluscum contagiosum and in advancing our clinical stage programs. Following Noah's appointment in early April, we welcomed Dr. Gavin Corcoran to our board of directors. Over his career, Gavin has built an outstanding track record of developing and launching innovative medicines, as well as creating significant value through strategic transactions. As we execute our strategic objectives, his expertise will help guide us in our decision-making, and I look forward to working with him as we enter our next phase of growth. I will now turn the call over to our Interim Chief Financial Officer, John Kirby, to review our first quarter 2025 financials.