Arcutis Biotherapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Arcudis Biotherapeutics Q1 2023 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message confirming that your hand is raised. To withdraw your questions, please press star 11 again. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your speaker today, Eric McIntyre, Head of Investor Relations. Please go ahead, Eric.

Thank you, Mark. Good afternoon, everyone, and thank you for joining our QDSIS first quarter 2023 earnings call. Slides for today are available on the investor section of our website. On the call, we have Frank Watanabe, President and CEO, Ken Locke, Chief Commercial Officer, Patrick Burnett, Chief Medical Officer, and Scott Burrows, Chief Financial Officer. During this call, I'd remind everyone that we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. We encourage you to review the information disposed in our latest SEC filing. And with that, I'll hand the call over to Frank to kick us off.

All right. Thanks, Eric. So, I am on slide five of the deck, for those of you who are following along in the deck. and provide a high-level overview. During the first quarter of the year, we made strong progress in laying the foundation for sustained long-term growth at Arcutis. I'll start with Zoriv, our innovative product for plaque psoriasis. We believe this product is very well positioned for long-term success with the real potential to eventually replace topical steroids. And physician and patient feedback has been exceedingly positive, and the launch continues to build momentum. We're seeing encouraging script growth as physicians gain positive real-world experience with Zareve. We've roughly doubled our TRXs quarter over quarter in Q1, and we see continued growth in April. I think it's worth noting that we're at the last five branded topical launches, have seen growth stall somewhere between three and six months into the launch. We've now continued steady growth through nine months of our launch. We also continue to make progress on gaining broad, high-quality access for patients to Zoriv. We now have coverage at two of the three large PBMs, as well as a number of other large downstream health plans within just six months of our launch, and we're making good progress with the remaining large PBMs. We have now over 110 million commercial lives, which is about two-thirds of the commercial market, and I think it's important to note that over 90% of those patients have access to Zoriv without a prior authorization. which meets our goals for high-quality access for Zareef. We believe we should be able to get to over 80% commercial coverage before the end of 2023 and likely even sooner than that. I will note that while obtaining coverage is a necessary precondition for patients to gain access, it is not alone sufficient. And we are augmenting our field deployed forces to increase our pull-through of that coverage into covered prescriptions. And Kemp will talk a little bit more about that a little bit later. At the same time, we've made continued progress on regulatory milestones to expand to additional indications and geographies with topical raflimelast. We received a confirmation of our PDUFA date for the foam in seborrheic dermatitis in mid-December, which is setting us up for our first launch of the foam. We believe this product is massively differentiated, and there's a very high level of physician excitement around this product and a very high sense of customer urgency for this product, given the unmet needs in this area. We also recently received the approval of Zareeb Cream in Canada for plaque psoriasis, and the launch in Canada is going to be in the next couple of weeks. Obviously, it's a smaller market than the U.S., but we still think it's a very attractive opportunity. And this represents the first regulatory approval for Zareeb outside of the United States, which is another key milestone for our QDIS. We also had a presentation of late-breaker data from the Integument 1 and Integument 2 trials in atopic dermatitis at the American Academy of Dermatology meeting in March. We continue to get very positive physician feedback on the clinical profile in AD, especially the early onset, including the impact on itch in as little as 24 hours, which was presented at AAD, as well as the differentiated safety and tolerability profile, which is particularly important in atopic dermatitis. And we expect to file for approval in ages 6 and above in atopic dermatitis late in the third quarter, early fourth quarter of this year. We also just recently completed enrollment in the integument PED study in ages 2 to 5, and we expect to see top line data from that study in Q3. I would note that that will be a supplemental NDA. So that data is not a critical path for the aforementioned filing, late Q3, early Q4, and six and above. You know, really, so that we can capitalize on this incredible opportunity, we are adjusting our capital allocation priorities, and we're making some specific adjustments to drive success in our commercialization efforts. And Scott will provide some more details on that shortly. Turning to slide six, you know, I think Topical reflumilast really represents, you know, you hear this word a lot, but a pipeline in a product with potentially four unique products in one and multiple inflection points coming up ahead with, you know, potentially new launches every two or three quarters to the next several years. So with Zareve today, we're competing in a market of around 2 million topically treated psoriasis patients in dermatology offices in the U.S. The total TAM effectively doubles in size with the expected approval of Cevderm to more than 4 million patients in the dermatology office in the US. And then the TAM will nearly double again to almost 7 million patients in dermatologist offices with subsequent launch in AD. And then there's nearly as large an opportunity outside of the dermatology office with about 6 million additional patients being topically treated outside of dermatology offices, mostly in primary care and pediatrics. We do plan on a capital efficient partnership to allow us to access this broader opportunity outside the dermatology offices rather than building our own sales team. When you factor in all of these different opportunities, that's a six-fold increase over our current psoriasis market that we're targeting at the moment with Zareed. And I think that really speaks to the long-term potential of topical reformulast and Arcutis in the space. We think that the topical reformalized product profile is ideally aligned with what physicians and patients need and are looking for. And as I mentioned before, you know, the catalyst path really sets us up very nicely for a potential new launch every two to three quarters with Cevderm at the beginning of 2024, atopic dermatitis later in 2024, and then scalp and body psoriasis early in 2025. And with those introductory remarks, I'm going to turn things over to Ken.