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| Statement |
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| We think there's a strong market opportunity with pediatricians, and we've decided to make that a full effort to go after it |
| The Walgreens partnership is exciting as we look forward to the opportunity to grow that relationship and leverage Walgreens' physical footprint and existing relationships with derm-on-call to build community awareness and grow treatment rates |
| We're obviously very pleased with the significant accomplishments in 2023 and the progress we expect to make in 2024 |
| I'm pleased to say that our coverage metric has exceeded our internal expectations and we believe this will ultimately translate into an acceleration in prescription growth of YCANTH over the next several months |
| We are executing across our entire business and we believe our success is translating into growing awareness and utilization of YCANTH as the first FDA-approved therapy indicated from Alaska and the only commercially available FDA approved treatments |
| We think we made a very strong argument in our citizen's petition there is precedent for what we're asking for and we hope that the FDA rules in our favor |
| Our fourth quarter execution resulted in $1.9 million in YCANTH net revenue, which we believe demonstrates our continued progress in driving adoption and reflects growing confidence in our prescriber base as we work to expand coverage of YCANTH to over 200 million commercial and Medicaid lives at the end of the year |
| We continue to forge excellent relationships with dermatology and pediatrician practices, and we believe that our efforts to increase lives under coverage is laying the foundation for the expansive coverage needed to maximize the commercial opportunity for YCANTH |
| I'm very pleased with the productivity that Verrica continues to make across its commercial efforts and our pipeline |
| As Ted mentioned, we had our first full quarter of commercial operations and we are gaining increasing traction among dermatology practices, pediatricians and institutions |
| As you know as we're ramping coverage up, we have over 200 million lives now, which is exceptional for a product this young in its life cycle |
| It's a great opportunity for YCANTH |
| Gross product margins for the full year 2023 were 94%, which continued to benefit from certain components of standard cost of goods sold, including bulk production and assembly of applicators from our registration batches, having been expensed as R&D prior to approval |
| From an ex-US perspective, in December, we announced that Verrica’s development and commercialization partner, Torii Pharmaceutical, reported positive top line results from Phase 3 trial of TO-208, which is marketed as YCANTH in United States for the treatment of molluscum in Japan |
| With HCPs at major IDNs beginning to adopt and with several other significant formulary wins, the incremental hospital reps will be critical in driving demand pulling through orders and maximizing the market opportunity |
| We expect these wins to continue as we see more success in our efforts to combat unapproved compounding cantharidin along with the anticipate publishing of the J code on April 1st |
| We believe the J code will help grow Ycanth utilization among the U.S |
| So it's a very efficiently managed program by us and we're very judicious in how we go about doing it |
| But having both, having this 200 million lives and the J-Code now working in simpatico if you will, should really help accelerate the adoption of YCANTH even more |
| So Walgreens, the partnership with Walgreens is accelerating nicely as it just to recall why we went to that, it gave us an opportunity to further expand our insurance network within the specialty pharmacy world, right, adding a second pharmacy |
| Our focus on the pediatric footprint is fueled by encouraging inbound traffic, which is consistent with our internal market assessment of the Luscombe diagnosis from pediatric practices across the country |
| We also feel our agreement with DMS and the opportunity with the DoD will further accelerate adoption |
| TO-208 demonstrated similar results to YCANTH Phase 3 program and was well tolerated during the study |
| So the two plus two samples a pretty good spot to be in and we're tracking towards, how we modeled our thoughts around driving demand |
| But we're confident, but we will be successful one way or the other |
| We remain excited about the opportunity for this asset, which we view as either a potential non-surgical alternative to Mohs surgery or as a neoadjuvant chemo therapeutic for a larger base of cell carcinomas, including advanced tumors or non-resectable basal cell |
| As the fourth quarter came to a close, we transitioned into the first quarter, we saw wins on the institutional side of our business with major IDNs and hospitals aiding Ycanth to formulary and placing orders |
| With our first full quarter of commercial operations now complete, we're beginning to see traction in many of our targeted dermatology and institutional accounts as we execute our launch plan |
| There are a significant and growing interest in prescribing and adopting YCANTH among physicians and broad acceptance on the payer side |
| Well, we believe we're on track and well on our way to hit our timeline |
| Statement |
|---|
| Consistent with this reduction in the supply of compounding cantharidin, we are regularly hearing in the market about the lack of availability of compounding cantharidin and receiving inbound requests for Ycanth from providers who are also informing us that they can no longer obtain compounding cantharidin |
| As we witness the available supply of compounding cantharidin in the United States significantly decrease, we are further escalating our efforts to ban the EU legal importation of compounding cantharidin from Canada and specifically, the illegal importation of non-FDA approved cantharidin products from Dormer labs in Canada |
| At the same time, we've cautioned you that we may not see the results of our efforts immediately, rather we have said that as the cumulative effects of our plan started to take effect, we'd expect to see noticeable reduction in the availability of compounding cantharidin within a 12-month period of time |
| It's very painful |
| Please see the Verrica's SEC filings for important risk factors |
| And based on those risks and uncertainties, Verrica's actual results and timing of events could differ materially from those anticipated in such forward-looking statements |
| GAAP net loss was $67 million or $1.48 per share for fiscal 2023 compared to a GAAP net loss of $24.5 million or $0.72 per share for the prior year |
| Similar to the actionable results we saw from our efforts with the 503A and 503B pharmacies, we believe that as we continue to execute and escalate our intended strategies the illegal importation of cantharidin from Canada will be discontinued |
| Research and development expenses of $5.3 million in the fourth quarter of 2023 declined versus the third quarter of 2023 by $1.2 million, primarily driven by reduced stock compensation expense |
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