Arcutis Biotherapeutics, Inc.

Good day and thank you for standing by. Welcome to the Arcutis Biotherapeutics Incorporated Q3 2022 earnings conference call. At this time, all participants are in a 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 advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand over the conference to your first speaker today, Eric McIntyre, Head of Investor Relations. Please go ahead.

Thank you, Chris. Good afternoon, everyone, and thank you for joining Arcutis' first quarterly earnings call. On today's call, we have Frank Watanabe, President and CEO, Scott Burrows, Chief Financial Officer, Ken Locke, Chief Commercial Officer, and Patrick Burnett, Chief Medical Officer. During this call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. We will then go to Q&A after our prepared remarks. With that, I'll hand the call to Frank.

Thanks, Eric. Yeah, I'll just add my thanks as well for joining us for our very first earnings call. Today we're going to be talking about our third quarter performance as well as providing some general updates to you all on our business and the progress that we've made so far this year. So you should have access to the deck on our investor web page. I'm on slide five to start with. You know, we've been talking all year long about 2022 being a transformational year for Acutis. We've already delivered on a number of very important catalysts, and we've got one very big one coming up just ahead of us. As you look at this slide, I think it's really remarkable everything that our organization has been able to accomplish just in the last three quarters, in the last three months, excuse me, in the last quarter. Obviously, first and foremost was the launch of Zorii's 0.3% cream for plaque psoriasis. This is a massive step forward for us in fulfilling our mission of helping patients and bringing meaningful innovation to dermatology. The launch continues to progress really well, and momentum is building, and we've got the right team. We're confident we have the right strategy, and we certainly know that we've got the right product profile in Zorii's. continue to prove all of that and then to seek out additional reform less indications as we as we've talked about before at seborrheic dermatitis atopic dermatitis and scalp psoriasis and Ken is going to be talking a little bit more about the the launch in in just a few minutes I want to take just a minute to talk about the very exciting access wins that we just announced about an hour ago I think that this is a validation of our responsible pricing strategy and is delivering on the broad high-quality access that we've been talking about, I want to emphasize these are fully executed agreements as well as actual coverage. This is not just a contract being signed, but an actual coverage for our product for a major PVM and for a major health plan. Tim's going to talk a little bit more about that as well in his comments, but this continues to build on our launch momentum with differentiated coverage. that is very high quality and ultimately is going to be less burdensome for prescribers and patients. I think we've made really good progress on building a sustainable and leading medical dermatology company through the continued development of our pipeline. We're going to talk a little bit more about the Ducentis acquisition earlier this quarter in just a minute and why we're excited about that acquisition. And then Patrick is going to also walk us through some very exciting top-line results in more detail from the Erector study in scalpel body psoriasis And I will have to say, I do have to say, I think physicians are phenomenally excited about our foam product for both seborrheic dermatitis as well as for scalp. We think that offers real innovation as well as some competitive insulation for something like the 40% of patients with psoriasis who have scalp involvement as well as the seborrheic dermatitis population. I think as everyone is very well aware, we've completed enrollment in both integument 1 and integument 2 in atopic dermatitis. We're cleaning the data, running the analyses right now, and we look forward to sharing those data with you from both studies before the end of this year. And then Scott's going to talk a little bit more about our financial position, but we're feeling very differentiated in the biotech space right now, given the strength of our balance sheet on the back of the two financings that we accomplished in August, both the equity deal and the debt deal. And that gives us really the requisite funding for both the launch of Xoriv as well as funding our growing pipeline in immunodermatology. Turning to slide six, I think many of you have seen this before. This is just our pipeline slide, and I really just want to touch on this to recognize our continued progress across our various programs and continue to build for the long term by harnessing our unique topical formulation expertise as well as our deep dermatology clinical development expertise And that's both innovations that are coming from our internal engine, and Patrick's going to talk a little bit more about the progress on our preclinical programs, as well as through external innovation, such as the business development deal we did with Ducentis for the CD200R asset. On slide seven, let me talk for just a couple minutes about the Ducentis opportunity. We really see this acquisition as being transformational for us as a company, and really moves us significantly forward in our journey to become the preeminent immunodermatology company. You know, I think most importantly, it's important to emphasize that we are really sticking to our knitting in terms of our stated strategy. It's consistent with our priorities. This is a large market with very large unmet medical needs still. It's a biologically validated target, and this looks like it potentially could be a best-in-class molecule. As we said before, we don't do Me Too products. And, you know, we don't consider ourselves just to be a topical company, never have thought of ourselves that way. Over half of our medical, commercial, and manufacturing organizations already have experience in biologics, and we'll be leveraging that expertise to continue to progress candidates, including Ducentis, through the clinic and into commercialization. And the Ducentis molecule is really complementary in atopic dermatitis to the flumelastic. And it enhances our ability to potentially offer treatment options across the spectrum of disease from mild to moderate on the one hand to severe at the opposite end, the extreme. And then finally, you know, we were able to acquire the asset for a very modest upfront investment and minimal spend in the short term. And so it doesn't have a significant impact on our financial outlook going forward. You know, folks have asked us on the next slide now why we're so excited about this target. Again, as I said, we see a very large unmet need in atopic dermatitis in spite of all the recent progress. It's a very large and rapidly growing market. I think Dupixen is a very good drug, and you've got some newer options coming along as well. But even with those innovations, less than half of patients are able to achieve a 75% improvement in their disease. And so we see a real opportunity to continue to advance the standard of care. Checkpoint agonism is a very exciting emerging strategy in immunodermatology. It's really the opposite of the checkpoint inhibitors that many of you are probably familiar with from the oncology space. If you agonize the checkpoints in the immune system, you reset overactive immune cells. So you're able to modulate overactive immune cells without really immunosuppressing. Earlier this year, we saw some data that was released by a competitor with a monoclonal antibody against CD200R We were very interested in that data. I think it showed some really impressive efficacy in humans. And I think probably one of the most remarkable things was the durable response with up to 12 weeks of efficacy even off drug after treatment had been ended. And that was really what led us to get much more excited and greater conviction around CD200R. And so we launched an effort to find a CD200R asset. We identified Ducentis. and we're able to acquire what we are now referring to as ARQ234, which is a fusion protein against CD200R. And we believe, based on the data we've seen thus far, I think ARQ234 offers us a great opportunity for potential differentiation on efficacy or potentially on a better dosing regimen, so some important points of differentiation. So we look forward to updating you in the coming quarters as we progress that program as well. And with that, I'm going to turn it over to Ken to talk a little bit more about the Zareed launch. All right.