Verrica Pharmaceuticals Inc.

Good morning, ladies and gentlemen, and welcome to the Verica Pharmaceuticals Third Quarter 2023 Corporate Update and Earnings Conference call. 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 third quarter 2023 corporate update and earnings conference call. With me on the line this morning are Ted White, President and Chief Executive Officer of Verica Pharmaceuticals, Joe Bonacorso, Chief Commercial Officer, Terry Kohler, Chief Financial Officer, Dr. Gary Goldenberg, Verica's Chief Medical Officer, and Chris Hayes, Verica's Chief Legal Officer. As a reminder, during today's call, management will make forward-looking statements. These statements may include expectations related to the commercialization of Y-CAMP in the United States, Verica's clinical development programs and product candidates, as well as 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, we 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. Our earnings release that we issued today includes GAAP and non-GAAP reconciliations for these measures and is also available on the investor relations section of our website. I'll now turn the call over to Verica's President and CEO, Ted White. Ted?

Thank you, Kevin. And good morning, everyone. And thank you for joining us for our third quarter 2023 corporate update and earnings conference call. I'd like to begin today's call by providing a general update on the progress we've made since the second quarter. I'll then turn the call over to our Chief Commercial Officer, Joe Bonaccorso, who will provide a more detailed review of our commercial activities and launch of Y-CANTH in the United States. Following Joe's remarks, our Chief Financial Officer, Terry Kohler, will review our third quarter financial results. We'll then open up the call to take your questions. The third quarter of 2023 proved to be a momentous period for our company. In July, the FDA approved Y-CANTH for the treatment of molluscum contagiosum or molluscum. in adult and pediatric patients two years of age and older. The first ever FDA approved product aimed at treating the six million patients in the U.S. who suffer from this highly contagious viral skin infection. We are very pleased with the high awareness and initial reception of WICAMP. Physicians and their patients who suffer from luscombe have waited a long time to have a safe and effective FDA approved therapy to treat this disease. Based on the feedback we've received to date, we are confident in YCANT's ability to address this disease, including that the design of the applicator itself allows for precise administration to each lesion. In addition to the positive reception and feedback we've been receiving for YCANT, our distribution model is well received by the dermatologists and pediatric communities. As a reminder, Physicians can obtain Wycanth in two primary ways. The first is a white bag service with our specialty pharmacy partner, New Factor. The second is on buy-and-bill basis directly through our distributive partner, FFF Enterprise. We believe our buy-and-bill model is resonating well with healthcare providers, and we believe it will be a driver of future demand. As a reminder, under our buy and build model, YCANT is currently reimbursed under a miscellaneous J code, which is expected to be replaced by an assigned permanent J code by January 2024, which should be published by April of 2024. We were just granted a C code, which is used by hospitals and clinics on a temporary basis until our J code is assigned. We expect that physicians who select to use our buy and build distribution model will typically realize a 6% to 10% margin on ASP, which would not be available utilizing a specialty pharmacy in a white bag service. Our launch activities for YCANTH are supported by a favorable balance sheet, enabling us to execute our commercialization activities. Soon after receiving FDA approval for YCANTH, we announced a non-dilutive financing that extended our estimated cash runway into the first quarter of 2025. At this time, we believe we have sufficient capital to support the YCAMP launch and the continued advancement through phase two of VP315, our novel oncolytic peptide being studied for the treatment of basal cell carcinoma. I'll provide a brief on this program in just a minute. On August 21st, we held our WICANT National Launch Meeting to prepare for the launch of WICANT. By the end of September, all 60 sales representatives were deployed into the field and were actively calling on their targets among over 8,500 healthcare providers identified in our launch strategy. In August, we received our first sale of WICANT to our exclusive distributor, FFF Enterprises, which resulted in net YCAMP product revenues of $2.8 million in the third quarter. In a few minutes, Giovanna Corso will share some details with respect to our marketing and reimbursement strategies to support the launch of YCAMP. While we're obviously excited by the reception for YCAMP, we're also mindful that healthcare professionals continue to use unapproved contheritin-based products in some markets remain a challenge. Our efforts to clear the market of those unapproved drugs continue to proceed through the FDA and other available venues. To be clear, we believe that both federal and state law and regulations require, among other things, healthcare providers to have a valid prescription and a medical reason for prescribing a compounded product instead of prescribing our FDA approved product. Moreover, we believe that it is a violation of federal and state law and regulations for pharmacies and healthcare providers to order compounded contheritin as office stock for use on more than the single patient for whom they write a valid prescription, as well as procure product from unauthorized trading partners in violation of the DSCSA. In August, we also issued a statement in support of the FDA's recent action against certain retailers, including Amazon and Walmart, and manufacturers that warn consumers not to use unapproved products for the treatment of molluscum. We applaud the FDA's decisive actions to safeguard the public against these unapproved products, which supports the view that molluscum is a serious and prevalent health problem that requires medical intervention with therapies that have been rigorously tested and reviewed by regulatory authorities. As a reminder, Y-CANTS approval was based upon positive data from two well-controlled Phase III trials demonstrating the clinical safety and efficacy of Y-CANTS so that millions of people, primarily children who suffer from this viral infection, can finally receive a safe, effective, FDA-approved treatment for their condition. To further underscore our commitment to patient health, In September, we filed an import alert to halt the illegal importation of compounded contheridine from Canada into the United States. In October, we filed a citizen's petition to, among other things, remove contheridine from both the 503 and the 503 bulk substance list. We are also requesting that the FDA utilize its enforcement discretion to clear the market of all unapproved contheridine drugs and issue warning letters to those entities who are in violation of the applicable laws and regulations. And finally, we are investigating private right of action claims against individuals and entities who are violating the law. We also remain quite active on the educational front. On October 11th, we held a virtual KOL event for investors to discuss the approval of YCAMP, which featured Dr. Mark Kaufman, from Advanced Dermatology in Miami, Dr. Michael Cameron of Cameron Dermatology in New York City and also the Department of Dermatology at Mount Sinai, and Dr. Mercedes Gonzalez, Pediatric Dermatologist in the Dermatology of Miami. This event was well attended and attracted a broad array of institutional investors. Finally, I'd like to provide a brief update on BP315, our novel oncolytic peptide, which is being developed for the treatment of basal cell carcinoma, or BCC. In August, we announced the presentation of lesion clearance data from part one of our ongoing phase two trial. These data highlighted the anti-tumor response of BP315 as determined by clinical and histological clearance of treatment basal cell carcinoma lesions. Dr. Neil Bhatia, Director of Clinical Dermatology, Therapeutics, and Clinical Research in San Diego, and Principal Investigator for the study, presented the data at the 2023 American Academy of Dermatology Innovation Academy. Based on the early but encouraging results from Part 1, we recently expanded Part 2 of the ongoing trial. VP315 continues to show potential to be a non-surgical, non-invasive, therapeutic approach for the treatment of basal cell carcinoma, and we look forward to providing another update on this program in the first half of 2024. I'd now like to turn the call over to Joe Bonacorso, who will review our commercial activities and the YCAMP launch. Joe?