Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) Q4 2023 Earnings Call Transcript
Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) Q4 2023 Earnings Call Transcript February 27, 2024
Arcutis Biotherapeutics, Inc. misses on earnings expectations. Reported EPS is $-0.72 EPS, expectations were $-0.65. Arcutis Biotherapeutics, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good day and welcome to the Arcutis Biotherapeutics' 2023 Fourth Quarter and Full Year Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to Derek Cole, Arcutis Investor Relations. Please go ahead.
Derek Cole: Thank you, Andrew. Good morning everyone and thank you for joining us today to review 2023 financial results and business update. Slides for today are available on the Investors section of the Arcutis website. On the call today we have Frank Watanabe, President and CEO; Patrick Burnett, Chief Medical Officer; Todd Edwards, Chief Commercial Officer; and John Smither, Chief Financial Officer. I'd remind everyone that we will be making forward-looking statements during this call. These statements are subject to certain risks and uncertainties and our actual results may differ. We encourage you to review all of the company's filings with the Securities and Exchange Commission, including descriptions of our business and risk factors. With that, let me hand the call over to Frank.
Frank Watanabe: Thanks Derek. I'm now on Slide 5 of the deck. We've had a lot of really exciting progress since we last spoke for our Q3 earnings call, and I couldn't be more pleased with the Arcutis team and our execution in the quarter. We're more excited about the foundation these results laid out for progress in 2024. We continue to see growing momentum in the ZORYVE cream launch in psoriasis as healthcare providers and their patients see how it addresses real needs in their treatment of psoriasis. [Technical Difficulty] 165,000 prescriptions and over 10,700 unique prescribers to launch to-date as our product delivers positive clinical experience for HCPs and their patients. We continue to make significant progress on our gross-to-net each quarter with improvement in Q4 over Q3 of a similar magnitude as seen Q3 over Q2, taking us to an average in the mid-60s for the fourth quarter.
The solid growth in prescriptions, coupled with continued gross-to-net improvements drove strong revenue growth in Q4, both versus Q3 and year-over-year with fourth quarter net revenue of $13.5 million. Coming on top of our progress with ZORYVE cream in psoriasis, we also received approval for ZORYVE foam for seborrheic dermatitis in December and launched in late January. I don't think I've ever seen comparable levels of excitement amongst patients and dermatologists as what we're hearing about ZORYVE foam. We also continue to execute against our clinical and regulatory milestones with a steady flow of successes this past quarter. Patrick will go into a little more detail in a minute. But during the quarter, the FDA accepted our supplemental NDA for atopic dermatitis down to the age of six and assigned a target date of July 7, 2024, potentially expanding our portfolio even further.
We also released very exciting interim long-term data from our open-label study in AD that demonstrated efficacy continues to improve with long-term use out to 52 weeks, along with favorable long-term safety and dependable disease control. We've seen robust, consistent and predictable efficacy across all targeted indications, including psoriasis, SebDerm and atopic dermatitis in each of their respective pivotal trials. In addition, in October 2023, the U.S. Patent and Trademark Office awarded the company a new formulation patent that covers a means for inhibiting roflumilast crystal growth that is not limited to hexylene glycol. And in November 2023, the company was also awarded a new method of treatment patent covering a topical roflumilast formulation with an extended half-life.
Both patents do not expire until 2037. And in October, we completed a secondary offering that raised $102 million, putting us in a strong financial position to continue investing in the ongoing launches in plaque psoriasis and SebDerm as well as the potential atopic dermatitis launched later this year, while continuing to develop -- the development of our pipeline. Moving on to Slide 6. A major reason why we're so excited for this year is that we are in the midst of a very significant expansion of the opportunity for topical roflumilast, which we expect will translate into a substantial acceleration of our revenue trajectory. You've seen this before, but from the initial approval for psoriasis, the total addressable market for ZORYVE could grow around 10-fold this year alone to over 15 million patients in the United States.
We have the right commercial team in place for success, and we have an excellent plan to execute against these opportunities. With that, let me turn it over to Todd to provide some further commentary around the ZORYVE cream launch in psoriasis and update you on how the foam is progressing in SebDerm.
Todd Edwards: Thank you, Frank, and I'm very enthusiastic about our growing commercial portfolio, recent progress, and a tremendous opportunity I see ahead. Moving to Slide 8. The ZORYVE psoriasis launch is accelerating, and our execution strategies are showing signals that we are able to push the launch trajectory in psoriasis. These efforts also lay a solid foundation for sustained growth in SebDerm and potential further growth in new indications upon approval. The NRx and TRx prescription volume is growing every quarter, and ZORYVE has over 165,000 TRxs launched to-date. Fourth quarter 2023, TRxs were up 26% compared to Q3 2023 and over 290% compared to the fourth quarter of 2022. We are starting to see a preference for ZORYVE relative to the non-steroidal competitor as evidenced by our steady gains in market share and eight in 10 ZORYVE riders are increasing their utilization of ZORYVE.
The new pediatric label expansion down to six years of age, incrementally expands our opportunity for growth and further strengthens ZORYVE's safety and tolerability profile. Refills continue to be an important driver of long-term growth. The number of refills in the fourth quarter increased by around 39% versus the third quarter and now constitute more than one in three prescriptions, which is in line with what we want and expect to see given the positive experience patients have with ZORYVE. I am now on Slide 9. There are multiple important dermatology conferences in January. After spending time with dermatologists, MPs, and PAs currently using ZORYVE cream, the feedback I received about the product is exceptional. These prescribers spoke to me about their patients being delighted by the results achieved with ZORYVE.
The prescriber feedback is clear that there are some distinct attributes of ZORYVE cream that make it attractive. The ability to be used anywhere, once daily dosing, compelling efficacy data, favorable tolerability profile, safety, and appropriateness for any psoriasis patients. And these attributes make ZORYVE cream an attractive treatment for patients with different types of needs, the patient who is concerned about steroids. The patient who has been cycling through various topicals, or ones that are exploring different treatments to find that works for them long-term or to manage flares. We know that psoriasis patients have different needs depending on where they are in their journey and see that ZORYVE cream can really be a solution for most of these patients.
I'm now on Slide 10. The team has been focused on three pillars of commercial success for sustaining ZORYVE cream growth in psoriasis. Firstly, driving HCP awareness and use. The prescriber base is growing steadily with now over 10,700 unique prescribers since launch. Our experienced field sales team is focused on high-volume geographies. The field team continues to deliver broad efficacy messaging to move physicians along the adoption curve from initial trial in specific regions of the body to expanded use for patients who have psoriasis plaques across a large body surface area. Secondly, patient engagement and positive use experience. Refill volume has increased to 38% of total volume as the re-patient awareness continues to improve. And finally, the broad high-quality access in commercial and anticipated Medicare-Medicaid coverage creates the opportunity for more patients to experience ZORYVE.
ZORYVE's differentiated pricing and access strategy continues to resonate with payers with over 132 million commercial lives having access to ZORYVE cream. The Arcutis team successfully secured coverage for ZORYVE cream with all three large PBMs in the U.S. within 12 months of the launch. And we anticipate further improvements in ZORYVE commercial coverage throughout 2024. And PAs and step edits are typical for branded products in dermatology. And for ZORYVE, this process is now well-understood by pharmacies and dermatology offices. We are seeing very encouraging trends in percentage of cream prescriptions being covered by insurers with a clear opportunity to expand on this by working with contracted pharmacy partners. From my experience, I am confident in our ability to continue to improve our gross-to-net.
We saw very good improvements in gross-to-net during Q4 and expect that progress to continue in subsequent quarters with us approaching our target gross-to-net in the 50s for the psoriasis indication by the second half of 2024. One very large entire opportunity to accelerate prescription growth is the expansion into Medicaid and Medicare, which we expect to begin as early as 2024. Roughly one-third of psoriasis patients and nearly half of SebDerm and atopic dermatitis patients are on Medicare or Medicaid. So, this is a very important opportunity for us. ZORYVE's pricing falls below the CMS specialty threshold tier, unlike other branded topicals. So, we are well-positioned to access these segments. Now, moving on to Slide 11. We are seeing a tremendous early response to the launch of ZORYVE foam.
The first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades. As you have likely seen in IQVIA data, we have a strong start to the launch with a very positive launch trajectory. The first approved treatment unconstrained by severity, duration, and location. ZORYVE foam is different than anything else derms or patients have seen for this disease. With treatment success of eight in 10 patients in our pivotal trial with over half of these patients completely clear in just eight weeks. Significant impact on itch, most symptom of this disease, with improvements seen as early as 48 hours, simple, once-daily leave an application that's much more convenient than any other option. And taken together, we believe ZORYVE foam can be the new standard-of-care imagining in SebDerm.
I'm now on Slide 12. With the product profile offering rapid dramatic disease clearance and significant reduction in itch with a simple single treatment, HCPs and patients are very enthusiastic about the availability of ZORYVE foam. 81% of survey prescribers view that ZORYVE foam profile as very compelling or compelling. They also recognize the attributes of applicability to any part of the body. The uniqueness of the vehicle and critical efficacy needs for this patient type of rapid response at itch and erythema, which then helps to reduce the number of treatments in the regimen and potentially leads to improved compliance. On Slide 13, as mentioned previously, we have secured access with the three national PBMs who recognize the ZORYVE foam as a line extension under the ZORYVE cream contracts.
This has translated into an increased volume of covered prescriptions early in the launch period with covered prescripts already near 50% of total volume. We continue to work with the downstream health plans, leading them on board, and this accelerated coverage, which translate into a more rapid improvement in gross-to-net compared to what we saw with the cream launch [Technical Difficulty] derm products. Finally, all the key EMRs already have ZORYVE foam available for electronic prescribing. Moving to Slide 14. Building on the strength of label and product profile, we are confident that we have the ingredients in place for successful launch of ZORYVE foam in SebDerm. With relationships already built with dermatologists, a field team trained on a value proposition and ready to promote and educate, contracted pharmacies in place, familiarity with the co-pay card and processes that go with the product, and access of PBMs ensure patients get the drug.
I look forward to updating you further on our commercial progress throughout the year. We are also looking forward to upcoming launches in new indications. And so I will hand it over to Patrick to cover that.
Patrick Burnett: Thanks Todd. I'm extremely proud of the team's performance in delivering on the promise of topical roflumilast in the dermatology community and hitting all our timelines with regard to our regulatory milestones. On Slide 16, I'm going to cover these according to indication with psoriasis first. Here, we have approval down to the age of six after we have expanded the indication and the opportunity in pediatrics to reach the two to five-year-old's will be the subject of a future FDA review. Next, for SebDerm with our approval in December and the recent launch, physician excitement is palpable and the feedback at Medical Congresses has been very positive. The profile here is unprecedented efficacy with a once-a-day foam in a market as big as psoriasis with no innovation in decades and no branded competition.
So, moving on to atopic dermatitis. As Frank mentioned, the FDA accepted our supplemental NDA for roflumilast scream as a potential treatment for atopic dermatitis for patients down to the age of six, and they assigned a PDUFA action date of July 7th of this year. And finally, we're also expecting to submit another sNDA with the FDA for ZORYVE foam in scalp and body psoriasis in the second half of 2024. On Slide 17, I want to highlight some recently released pooled data from our Phase III AD studies INTEGUMENT-1 and 2, and it's quite notable and highly unusual that over 90% of patients saw improvement in their symptoms in just four weeks and nearly 70% seeing at least a 50% improvement. Looking at the more demanding EASI-75-hurdle, almost 45% of patients achieved this large improvement at week four.
And encouragingly, in the long-term study, which we've released, but aren't showing here, at the end of 56 weeks, two out of three patients had achieved a 75% improvement. It's really exciting to see where we have a high proportion of patients responding early and then seeing an increased benefit over time with long-term treatment. And in that long-term study, we also looked for the first time and our ability to control the disease with a less frequent maintenance regimen, where patients were switched to twice weekly treatment if they reach complete clearance. We're really happy about the response there and this regimen fits nicely with the current clinical practice, and these data have really resonated with dermatologists. We're excited about the roflumilast cream clinical profile for AD and the significant opportunity in this large and growing market.
Dynamics here at AD are favorable towards rapid adoption and share some of the positive tailwinds as SebDerm. And in pediatric patients, especially here in AD, there is a propensity to adopt non-steroidals higher than in the psoriasis patient population, and that's largely driven by parents' avoidance of steroids. So, moving on to Slide 18. I want to highlight the itch response across our portfolio of products. So here, we're showing WIN-NRS or worst-itch numeric rating scale results of our Phase III studies. These are pooled results for psoriasis dermis and the AD INTEGUMENT studies, and these are individual study results for STRATUM and ARRECTOR. Itch is a primary symptom for these conditions and a key driver of our quality-of-life impact.
So, ZORYVE cream and foam at 0.3% and topical roflumilast 0.15% cream for AD provided consistent and rapid improvements in itch across psoriasis, SebDerm, and AD, respectively, with improvements as early as 24 to 48 hours as compared with vehicle-treated patients. This includes scalp psoriasis in the ARRECTOR study, which is particularly difficult to control and only four weeks of treatment in the INTEGUMENT studies. Across indications, we have a significant proportion of patients achieving an itch-free state. And with that, I'll pass it over to John.
Frank Watanabe: Operator, can you hear me? This is Frank.
Operator: Yes, I can hear you now.
Frank Watanabe: While we're working on John, I'll take over for him for just a minute. So, if you're listening, so, I'm on Slide 20. So, we achieved $29.2 million in net product revenue for ZORYVE for the full year 2023, with $13.5 million of that in Q4, reflecting a 67% growth from Q3 to Q4, which comes on top of the approximately 70% sequential growth we saw from Q2 to Q3. This was driven by substantial growth -- gross-to-net, excuse me, percentage improvement down in the mid-60s and the team's success in pulling through covered prescriptions. We also saw a healthy prescription growth in the quarter. So, looking forward to 2024, we expect continued prescription growth and gross-to-net improvements for ZORYVE cream in psoriasis and continued prescription momentum and GTN improvements for ZORYVE foam, although there will likely be a temporary erosion in psoriasis gross demand improvements in Q1 2024 versus Q4 2023 due to the typical deductible resets and patients changing their coverage that always occurs at the beginning of the year.
Turning to Slide 21, you can see the strong performance in the fourth quarter with net product revenues for the quarter of $13.5 million, up over $10 million from Q4 of 2022. R&D expenses for the fourth quarter were $23.8 million, which is down significantly from Q4 2022 due to continued decrease of development costs on topical roflumilast programs. And recall that our R&D expense includes research, operations, and medical affairs spend. On Slide 22, looking at full year. Full year total revenues of $60 million with $29.2 million in net product revenues and $30 million in other revenues related to the upfront payment in connection with the Huadong collaboration and licensing agreement we received in Q3. R&D expenses for full year were $111 million, which is down $70 million, approximately due to the one-time $30 million fee associated with the Ducentis acquisition in 2022, winding down of our major roflumilast Phase III studies and lower pre-commercial production.
We expect full year 2024 R&D expense to decline meaningfully versus full year 2023 as we continue completing the few remaining Phase III studies continuing with regulatory filings, reduce our prelaunch production costs, and maintain our medical fares activity to support the launches. SG&A expenses for the year were $185 million, primarily due to higher commercialization expenses year-over-year, driven by continued investments in ZORYVE cream and preparing for the ongoing launch of ZORYVE foam and the potential upcoming launch in atopic dermatitis, if approved. As we head into 2024, we expect SG&A to increase over 2023, which aligns with the investment behind our SebDerm launch and preparations for the atopic dermatitis launch, including our previously announced incremental expansion in sales force.
We will continue to focus on appropriate investments to support our commercial activities. Launching drugs properly require substantial investments in staff and promotional investment and having multiple launches in a short period of time really magnifies these resource demands. It's important to note that we have made concerted efforts to adjust our operating expenses to reflect our transition from being exclusively a pre-commercial company to a commercial enterprise and ensuring we invest appropriately in current launches and if approved, ensuring the same for our future launches. We don't want to be in a position of underinvesting and harming the trajectory for the ongoing launches in psoriasis and SebDerm or future launches if approved.
Earlier in the year, we undertook a reorganization and reprioritization of non-commercial efforts to align with our commercial execution focus in 2024, which will result in aggregate approximately $50 million of reduced expenses over the next two years as compared to previous internal forecasts. You can expect us to continue to focus on cash burn as we look for opportunities to maximize our OpEx, while making continued progress on maximizing the ZORYVE opportunity across multiple unique indications. A top priority for our team is being good stewards of the investor capital interested to us, and we believe we have demonstrated an excellent track record thus far. We have made appropriate levels of investment that established our pipeline achieved nine positive Phase III clinical trials and now two FDA approvals with the third potentially coming midyear, while launching two products to-date and if approved, another in the second half of 2024 and a fourth in 2025.
On Slide 23, our final slide, on the balance sheet, we had cash and marketable securities of $272.8 million as of December 31st. As I mentioned on a previous slide, our current capital enables us to continue to invest appropriately in commercial initiatives. We also remain confident about concluding an out-licensing deal in Japan to bring in additional non-dilutive capital, which would further extend runway and largely address the capital requirement covenant with SLR. Additionally, we are actively pursuing a primary care partnership and are seeking -- and seeing early interest from our efforts there. So, that's it for our comments today. If I step back for a minute, we founded Arcutis with a vision of bringing meaningful innovation to the medical dermatology space, especially in the topical space.
With our second launch in less than 18 months, I'm proud that our team is making that vision in reality and in the process is helping a growing number of people suffering from dermatologic conditions. As we continue to execute on the psoriasis and SebDerm launches and hopefully adding atopic dermatitis launch later this year, we look forward to helping millions of people allowing us to create additional shareholder value. We are confident that 2024 will be a transformational year for Arcutis. And with that, we will open it up for Q&A.
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