Arcutis Biotherapeutics Q2 2026 Earnings Call Transcript

Quartr
Provided by Quartr
August 5, 2026

Key Takeaways

  • Positive Sentiment: Q2 net product revenue rose 59% year over year to $129.9 million, driven by strong ZORYVE demand and improved gross-to-net deductions. The company raised its full-year 2026 revenue guidance to $525 million–$540 million from $480 million–$495 million.
  • Positive Sentiment: ZORYVE received FDA approval for plaque psoriasis in children as young as two, while the FDA accepted the application for atopic dermatitis in infants down to three months, with a February 2027 decision expected. Management views the pediatric indications as significant unmet-need opportunities.
  • Positive Sentiment: Arcutis is investing in growth through expanded dermatology, primary-care and pediatric sales teams, direct-to-consumer marketing, a virtual dermatology platform and AI-enabled prescription fulfillment tools. The company expects the dermatology expansion to support second-half 2026 growth, with primary-care and pediatric contributions beginning in 2027.
  • Positive Sentiment: The company reported $15 million of net income and $12.6 million of operating cash flow in Q2, ending the quarter with $238.9 million in cash and marketable securities. Management expects positive cash flow for the remainder of 2026 while continuing to fund pipeline and commercial investments.
  • Negative Sentiment: Chief Commercial Officer Todd Edwards will leave later this month to pursue other opportunities, creating a leadership transition. Arcutis appointed Rob Lisicky as interim CCO while it conducts a permanent search, although management characterized the commercial team and transition plan as strong.
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Earnings Conference Call
Arcutis Biotherapeutics Q2 2026
00:00 / 00:00

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Operator

Ladies and gentlemen, thank you for standing by. Welcome to Arcutis Biotherapeutics, Inc.'s second quarter 2026 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 would need to press star one, one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one, one again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Brian Schoelkopf, Head of Investor Relations. Please go ahead.

Brian Schoelkopf
Brian Schoelkopf
Head of Investor Relations at Arcutis Biotherapeutics

Thank you, Michelle. Good afternoon, everyone, and thank you for joining us today to review our second quarter 2026 financial results and business update. Slides for today's call are available on the Investors section of the Arcutis website. Joining me on the call today are Frank Watanabe, President and CEO of Arcutis, Patrick Burnett, Chief Medical Officer, and Latha Vairavan, Chief Financial Officer. I would like to 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 the company's filings with the Securities and Exchange Commission, including descriptions of our business and risk factors. With that, let me hand it over to Frank to begin today's call.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Thanks, Brian, good afternoon, everyone. As always, we appreciate you guys making the time to join us on our quarterly update call. I'm going to start this afternoon with a review of our very productive second quarter as we continue to deliver meaningful innovation for patients with chronic inflammatory skin diseases and continue to execute against our grow, expand, build corporate strategy. Todd isn't able to join us today, I'll walk you through a commercial update, followed by Patrick for an R&D update, and finally, Latha will review the quarter's financial results before we open it up to questions. I'm on slide five in the deck. Just as a reminder, our three-pillar strategy to sustain near and long-term growth includes, first, growing our core ZORYVE business in our approved indications.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Second, expanding into additional indications where ZORYVE's unique profile as a targeted and potent PDE4 inhibitor has significant potential to address persistent therapeutic gaps. Third, leveraging our deep clinical expertise and infrastructure to build our pipeline beyond ZORYVE. I'm happy to report that once again, we made substantial progress across all three pillars during the second quarter. Let's start with our grow pillar. Our in-line ZORYVE business continues to strengthen and grow as we expand the reach and relevance of this medicine to the tens of millions of individuals with chronic inflammatory skin conditions in the U.S. who need and deserve new, innovative therapeutic options to manage their plaque psoriasis, severe dermatitis, and atopic dermatitis.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

As ZORYVE continues to grow, we're now in a position to reinvest the significant capital generated back into the business, creating a virtuous cycle of innovation that extends our transformative impact to more patients, both with ZORYVE and current and potential future pipeline assets. As we'll discuss today, our investment in innovation encompasses a broad range of value-creating initiatives across the business that we're advancing in parallel from multiple clinical projects to impactful patient access initiatives. Touching on some of the highlights, at the end of June, we received FDA approval for ZORYVE cream 0.3% for the treatment of plaque psoriasis in children as young as age two. This marks the seventh FDA approval for ZORYVE in four years, a remarkable accomplishment for a small company like Arcutis.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Importantly, this milestone enables us to address a significant treatment gap, introducing the first once-daily steroid-free treatment for plaque psoriasis approved down to age two. In July, the FDA also accepted our supplemental NDA for ZORYVE cream 0.05% for the treatment of mild to moderate atopic dermatitis in infants down to three months with a PDUFA date set for February 23, 2027. I was just recently at the Society for Pediatric Dermatology, and frankly, I was awestruck by the level of anticipation and excitement in the pediatric dermatology community about this potential approval, which would address an urgent unmet need for a once-daily nonsteroidal in these youngest of AD sufferers. Both of these regulatory milestones demonstrate our commitment to delivering meaningful innovation to both adults and children across all age groups, including the youngest children impacted by these chronic inflammatory skin diseases and their caregivers.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

As you'll hear more today, our commitment to meaningful innovation for patients goes beyond bringing new therapies to market. We recognize that managing a chronic inflammatory skin disease like psoriasis, atopic dermatitis, or seborrheic dermatitis can be extremely challenging and burdensome for the individuals and their families. With that in mind, we are turning our expertise to ways that we can innovate to enhance the patient experience and facilitate seamless access to treatment in order to help ease the burden on the patient and caregiver as well as the healthcare provider. Today, we'll detail some of our initiatives around patient access that specifically reduce barriers to care and streamline the patient journey. Our new virtual health platform and our strategic partnership with a leading AI-enabled patient access support tool are the first steps to emerge from our broader patient access initiative innovation workstream.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We're really excited about these initiatives, which I'll explain in greater detail shortly. Both are great examples of our commitment to delivering meaningful innovation to patients. Turning to expand our second strategic pillar, we continue to make important progress in this quarter in evaluating the potential of ZORYVE in additional chronic inflammatory skin conditions. Specifically, we have now fully enrolled the phase II proof of concept trial of ZORYVE in the treatment of vitiligo, and we continue to enroll the phase II proof of concept trials of ZORYVE as a treatment for hidradenitis suppurativa. On previous calls, we've shared the extensive and growing list of conditions where clinicians have published case reports or case series showing promising signals of ZORYVE efficacy, suggesting that ZORYVE's unique profile as a targeted and potent PDE4 inhibitor could offer additional patients an innovative non-steroidal therapeutic option.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We continue to evaluate these other potential indications and anticipate initiating one or more additional proof of concept trials this year. Finally, turning to the third pillar, build. We continue to make progress advancing our innovative pipeline. Enrollment is ongoing in the phase I-A, phase I-B trial of ARQ-234, our novel biologic targeting CD200R as a potential treatment for moderate to severe atopic dermatitis. By targeting CD200R, which plays a central role in both innate and adaptive immunity, we believe ARQ-234 could not only be an important first-line systemic therapy, but also has the potential to address the clear and distinct need for a treatment for patients with atopic dermatitis who have relapsed on, or who are refractory to IL-4/13 drugs. In addition, as we've discussed previously, external innovation will likely play a central role in expanding our pipeline.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We're seeing a marked increase in deal flow recently in both dermatology and adjacent inflammation areas. Our team remains actively engaged in evaluating a range of external assets as we look to build our pipeline. As Latha will describe, we had another very strong quarter financially. This level of performance and the cash flow that it generates enables us to continue to invest in innovation, staying true to our biotech roots and mission. For the remainder of this year, you should expect consistent execution against our stated strategy, opportunistic reinvestment in the business, a steadfast commitment to creating long-term value for both patients and shareholders.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Based on the strength of our ZORYVE business to date, in light of the incremental investments we are making to sustain demand for ZORYVE, we are delighted to raise our full year 2026 sales guidance from the previous range of $480 million-$495 million, to a range of $525 million-$540 million. You will recall that we made no changes to our revenue guidance during our Q1 earnings call. We don't anticipate revising it every quarter, this guidance really reflects the momentum that the business has seen through the first half of the year. Now let me delve a little bit more into some of the details on commercial results for the quarter. I'm now on slide seven.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We continue to see robust sales performance and demand-driven growth in the second quarter, with net product revenues of $129.9 million, representing a 59% increase from the second quarter of 2025, a 23% increase over Q1. Our consistently strong quarterly revenue underscores the momentum and enduring strength of the ZORYVE franchise. As expected, our gross net rate improved incrementally from the prior quarter continued to remain stable in the 50s. Looking ahead to the third quarter, we expect quarter-over-quarter net sales growth driven by sustained momentum in patient demand. Now let me turn to slide eight. Weekly prescriptions of ZORYVE on a rolling four-week average show sustained growth across the portfolio. We reached a new high watermark for quarterly demand with more than 280,000 prescriptions in the quarter across all indications and formulations for ZORYVE.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

As this chart highlights, ZORYVE continues to experience substantial prescription growth. We anticipate this growing demand will continue through the duration of this year and beyond and will be the primary driver of ZORYVE's revenue expansion. The most important driver of ZORYVE's growth will remain the conversion from topical steroids to advanced targeted topical therapies like ZORYVE, as healthcare providers' and patients' perceptions of the risk of chronic topical steroid use evolves. Let's turn now to slide nine. I want to expand on the patient access initiatives we introduced this quarter. As I highlighted in the opening, improving patient access to ZORYVE is an important dimension of meaningful innovation as we aim to deliver to patients with chronic inflammatory skin diseases. Therapeutic innovation is meaningless if patients are unable to access new therapies, so we see it as an imperative to also innovate in reducing barriers to treatment and care.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Importantly, these new patient access initiatives are separate and distinct from, but complementary to, our payer access efforts. These innovations are focused on enabling seamless fulfillment and an efficient post-prescription process that helps patients access ZORYVE rapidly, reliably, and efficiently. We've applied this holistic patient-first approach to innovation since bringing ZORYVE to market, but we're now broadening the scope of our patient access activities with the launch of our virtual health platform and investments in AI-enabled tools that support efficient prescription fulfillment. Two distinct initiatives, both with the aim of facilitating more seamless access to ZORYVE. A little bit more about each of these initiatives, starting with the virtual health platform, which we announced in June.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We recognize that over the last several years, patients have been rapidly changing how they obtain healthcare, starting with the COVID pandemic and accelerating with the emergence of multiple virtual health offerings like Hims or Ro. Many individuals today are seeking more convenient, flexible ways to receive care. Our virtual health platform recognizes this evolution and meets patients where they are by helping to address common barriers to dermatology care, such as long wait times for dermatology appointments and the absence of specialized dermatology care in some geographies. The platform provides an additional pathway for individuals who might otherwise delay or forego specialized dermatology treatment. Importantly, the platform is designed to complement and not replace traditional in-office dermatology care. Our goal is to help more individuals access the therapies that they need while continuing to partner with healthcare providers across dermatology, primary care, and pediatric settings.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

With Milo, board-certified independent dermatologists on the platform evaluate, diagnose, and determine appropriate treatment for each individual based on their clinical judgment. Arcutis does not influence diagnoses, clinical decision-making, or prescribing decisions made through the platform. If prescribed, ZORYVE prescriptions are coordinated through a national pharmacy hub designed to support a seamless experience, including insurance support and at-home delivery. We're especially excited about this new platform because we believe ZORYVE has an ideal profile for the virtual health model. Dermatologists can prescribe ZORYVE confidently given its demonstrated efficacy, safety, and tolerability without worrying about a patient applying the drug to an area of the body that they shouldn't, and with the knowledge that the patient can use ZORYVE for any duration. It treats the three most common inflammatory diseases, all of which can be diagnosed visually using telehealth tools.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Additionally, individuals suffering from these diseases are motivated to seek an effective therapy due to the burden of their symptoms. We're still in the early days of the rollout of our virtual health platform, but we are already seeing signals of the impact that it will have and are confident that this will have a meaningful benefit in expanding patient access to ZORYVE, particularly when it's coupled with other demand generation efforts we have, like the Free to Be Me campaign. In late July, we launched our second patient access innovation, partnering with one of the leading AI-enabled prescription workflow platforms to streamline the post-prescription process for ZORYVE in dermatology offices. The process for getting any prescribed therapy to an individual has grown increasingly complex and time-intensive over time. Through this partnership, we're helping to streamline patient access to ZORYVE after they receive the prescription.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

The company that we've partnered with is already widely adopted across dermatology offices as well as other therapeutic areas nationwide. In practices where the tool is implemented, after providers initiate a prescription, the platform helps navigate and systematize that workflow that follows. In addition, it supports patients with real-time visibility into the process from the moment of prescription, as well as other critical information and access resources. As part of the collaboration with Arcutis, the platform provides customized prompts and alerts to streamline the steps between a clinical decision and an individual starting ZORYVE, including prior authorization, financial assessment, and fulfillment routing embedded directly into healthcare provider workflows. We're skating to the puck. It's our belief that harnessing innovation and leveraging these types of technology-based solutions to help patients and healthcare providers with the fulfillment process for ZORYVE is where we need to be.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

These initiatives mark important additional steps in our mission to deliver meaningful innovation across every part of dermatology care. On slide 10, these patient access initiatives are only the latest example of how we're reinvesting the cash flow generated by ZORYVE back into the franchise to drive sustained growth and inflection in sales in 2027 and beyond. Of course, all of our efforts to drive ZORYVE's growth would be meaningless without the solid foundation of ZORYVE's outstanding clinical profile. ZORYVE's rapid and robust efficacy across multiple inflammatory dermatoses, paired with its exceptional safety and tolerability profile and its patient-friendly formulations, make it a compelling choice for healthcare providers and patients looking to manage these chronic conditions, especially against the backdrop of the growing concern about prolonged use of topical steroids.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Our commercial efforts focus on generating awareness of this differentiated therapeutic profile with both clinicians and patients, then enabling efficient patient access to the product when it is identified as the appropriate therapeutic intervention. Building on that foundation are three broad categories of demand initiatives. The first is the investments we're making to strengthen our commercial infrastructure through targeted additions to our sales force. The dermatology sales force expansion has been completed with our new dermatology specialty reps hitting the field as of early May. Since then, they've been gaining familiarity with their customers, and as previously discussed, we anticipate beginning to see the impact on growth from these reps beginning in the third quarter of this year. We have also now completed the build-out of the first phase of our primary care and pediatric organization, having recently completed the hiring of this targeted team.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We anticipate this sales force will be in the field interacting with primary care providers and pediatricians by the end of this month and expect to begin seeing the impact of this new team by 2027. As a reminder, we are adopting a highly targeted approach with this sales team, focusing on high-volume, early adopter PCPs and pediatricians who are concentrated in major metropolitan areas. This approach positions our investment in a PCP ped sales team to begin contributing value rapidly. As we gain more in-depth understanding of this space and how best to partner with primary care and pediatric providers, we'll evaluate further expansions of the team. We believe that some of the same attributes of ZORYVE's profile that have led to its leadership in dermatology and will drive meaningful adoption through the virtual health platform will also drive its success in the primary care setting.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Specifically, primary care and pediatricians can prescribe ZORYVE confidently based on its demonstrated efficacy, safety, and tolerability, without worrying where or how long patients use it. The second component of our commercial investment plan is our direct consumer efforts. We're driving meaningful patient engagement through our Free to Be Me patient awareness campaign, featuring Tori Spelling, her daughter Stella McDermott, and professional golfer Max Homa. This campaign is helping to drive awareness of treatment options for patients with atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, and the promise of ZORYVE across these indications. We're seeing these efforts resonate with a broad range of patient demographics, reflecting the broad swaths of the population impacted by these diseases. The effectiveness of this campaign is further bolstered by our virtual health platform, enabling us to provide a direct route to a dermatologist for individuals who discover ZORYVE through Free to Be Me.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We look forward to continued progress of this important direct-to-consumer effort as we work to capture and reflect patients' lived experiences as they manage their chronic inflammatory skin conditions, including using ZORYVE in their treatment regimen. The final component of our commercial investment strategy is facilitating seamless patient access to ZORYVE, as we've discussed today. The virtual health platform and AI-enabled prescription workflow efforts I described earlier are the initial efforts that we're making in this vein, but there are additional exciting initiatives to come, and we look forward to sharing details with those at a future date. With that, I'm going to take a breath and turn the call over to Patrick for an R&D update.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

Thanks, Frank. I'm on slide 12. At the outset of today's call, Frank highlighted our focus across the grow, expand, and build pillars of our corporate strategy. I'd like to provide some additional context for the clinical components of each pillar. Before I detail our various clinical initiatives, I want to emphasize the breadth of our ongoing activities to further bolster the profile of ZORYVE. On this chart, I'm showing the range of clinical programs we are pursuing to broaden our patient population, expand into new disease areas where we have early signs of efficacy, and better define the unique aspects of ZORYVE's therapeutic profile. The breadth of approved and potential uses of ZORYVE, supported by its pleiotropic mechanism of action and its safety and tolerability profile, underpin our belief that ZORYVE is uniquely well-positioned to supplant topical corticosteroids in the management of inflammatory dermatoses.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

Moving now to key clinical updates for the quarter. As Frank highlighted earlier, in late June, the FDA approved our supplemental NDA to expand the indication for ZORYVE cream 0.3% for the topical treatment of plaque psoriasis, including in intertriginous areas, to children down to the age of two. As a practicing dermatologist, I can personally attest that treating young children with plaque psoriasis presents unique challenges. Specifically, while safety and tolerability is always a concern, that concern is amplified in young children who may face decades of treatment and who are particularly susceptible to both local and systemic steroid exposure risks, like HPA suppression. In our trials in children as low as two years of age with plaque psoriasis, ZORYVE 0.3% demonstrated safety, tolerability, and efficacy comparable to that already demonstrated in adults and adolescents.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

ZORYVE is now the first once-daily steroid-free treatment for plaque psoriasis approved down to two. It provides healthcare providers, parents, and other caregivers with an advanced targeted topical therapy that can be used anywhere on the body for any duration of time, addressing a significant treatment gap for this very young and especially vulnerable patient population. In July, we announced that the FDA accepted our supplemental NDA for ZORYVE cream 0.05% for the treatment of mild to moderate atopic dermatitis in infants down to three months, with a PDUFA date set for February 23rd, 2027. As we mentioned on our first quarter call, we were able to submit this application just three months after having read out the top-line results from our INTEGUMENT infant trial.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

This remarkable feat reflects the speed with which our team at Arcutis is moving on behalf of patients and a response to the high level of urgency shared by those HCPs who care for these youngest atopic dermatitis patients. This urgency to advance new and more effective therapies is driven by specific challenges in treating this infant patient population. The skin of young children is not fully developed, which can lead to increased systemic absorption of topical treatments like steroids, and these youngest patients also often present with more extensive disease than adolescents and adults. During the quarter, we also initiated two new trials, one in adults to better elucidate ZORYVE's impact on pruritus or itch.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

The trial is called INTEGUMENT-Itch. It's based on the compelling data from the INTEGUMENT infant trial, showing reductions in itch within 10 minutes of first application. Another to evaluate the impact of ZORYVE on nail psoriasis, a notoriously difficult-to-treat presentation of plaque psoriasis, often even failing systemic therapy, where we have seen some really exciting signals of ZORYVE efficacy in case reports. Turning to potential new indications for ZORYVE, we've now completed enrollment in our phase II proof-of-concept trial in vitiligo. We continue to enroll the hidradenitis suppurativa, or HS, phase II proof-of-concept trials. Remain on track to provide a readout for the vitiligo trial and a decision on whether to advance the program in quarter four of this year. We remain on track for a similar readout for our HS program in quarter one of 2027.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

Recall that in our HS program, we have trials evaluating ZORYVE's safety and efficacy in HS, as well as a study looking at gene expression following ZORYVE treatment in HS patients. As we advance these phase II vitiligo and HS studies, we also continue to evaluate other diseases for similar proof-of-concept studies, and we anticipate starting one or more additional proof-of-concept studies in the latter half of the year. During quarter two, we also initiated a trial evaluating the impact of ZORYVE cream 0.3% on cutaneous adverse events in cancer patients receiving PD-1 or PD-L1 checkpoint inhibitor treatment. Such side effects occur in as many as half of patients receiving these life-saving treatments, and they often lead to interference with cancer therapy.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

If ZORYVE is able to effectively manage such treatment-related dermatoses, as suggested by some case reports, it may help cancer patients to persist with their PD-1 or PD-L1 treatment regimen. This trial is another meaningful example of the broad potential applications of ZORYVE across inflammatory skin conditions. Turning lastly to ARQ-234, our novel biologic targeting CD200R and the build pillar of our strategy. As Frank Watanabe touched on earlier today, by targeting CD200R, which plays a central role in both innate and adaptive immunity, we believe ARQ-234 has the potential to address the significant unmet need for a systemic therapy for patients with moderate to severe atopic dermatitis, and given the unique mechanism of action, could be a compelling first-line therapy option, as well as a treatment option for those who are refractory to IL-4/13 therapies.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

We've completed enrollment in the last cohort of healthy volunteers in the single ascending dose, or SAD portion of the phase I trial for ARQ-234. We've now begun enrolling atopic dermatitis patients into the final SAD cohorts, and we'll begin to enroll AD or atopic dermatitis patients in the multiple ascending dose or MAD portion of the trial. Following the MAD portion, we will complete a small proof-of-concept portion in atopic dermatitis patients as well. As I explained on our first quarter call, we'll not share our results from this trial until it's completed, but we'll continue to update you as we progress through these different portions of the study. We also continue to evaluate external sources for innovation to further build out our innovative pipeline. As Frank Watanabe mentioned earlier, we're encouraged by the increased deal flow in the dermatology and eye space. Turning now to slide 13.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

We introduced this slide at our R&D day last fall. It lays out the multiple characteristics a therapy would need to not only compete with topical steroids in chronic inflammatory skin disease settings, but also to displace them. ZORYVE is arguably comparable to topical corticosteroids in efficacy and rapidity of onset, but as depicted here, it then exceeds the steroid benchmark in mechanism-of-action breadth, safety and tolerability, and duration and location of use, with the degree of differentiation becoming increasingly pronounced across each dimension. ZORYVE's unique profile, coupled with increasing HCP appreciation of risks associated with sustained topical corticosteroid use, as we've reviewed in depth previously, sets the foundation not only for substantial growth in our three in-line indications, but also for potential expansion into a number of new indications.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

I wanted to review this perspective on ZORYVE's profile today as important context for the broad set of clinical activities that we're pursuing. The breadth and ambition of our clinical pursuits are unmatched in the branded non-steroidal topical segment and are enabled by ZORYVE's unique therapeutic profile. They further demonstrate why ZORYVE is uniquely positioned to displace topical corticosteroids at a moment when there is a growing degree of concern over the deleterious side effects of extended or inappropriate use of these aging drugs. I'll now hand it over to Latha to review the financial results for this quarter.

Latha Vairavan
Latha Vairavan
CFO at Arcutis Biotherapeutics

Thank you, Patrick, and good afternoon, everyone. I'm on slide 15. In the second quarter, we generated net product revenues of $129.9 million, representing a 59% increase from the second quarter of 2025. This year-over-year increase was driven primarily by increased patient demand as well as improvements in gross to net sales deductions. As anticipated, our gross to net in Q2 remained stable in the 50s. Cost of sales in the second quarter were $10.9 million, compared to $7.5 million in the second quarter of 2025, due to increasing ZORYVE sales volume.

Latha Vairavan
Latha Vairavan
CFO at Arcutis Biotherapeutics

For the second quarter of 2026, our R&D expenses were relatively flat at $20.4 million versus $19.5 million for the corresponding period in 2025, as increased investments in medical affairs initiatives and clinical expense related to ARQ-234 were largely offset by reduced clinical costs related to the INTEGUMENT infant trial in atopic dermatitis patients aged 3 to 24 months. SG&A expenses were $82.1 million for the second quarter of 2026, compared to $69.2 million in the same period last year, up 19%, driven primarily by personnel costs, including our dermatology sales force expansion. We produced net income of $15 million for the quarter as compared with a net loss of $15.9 million for the same period in 2025 as strong top-line growth continued to outpace expenses.

Latha Vairavan
Latha Vairavan
CFO at Arcutis Biotherapeutics

While we may continue to generate positive net income in some quarters, our focus as an innovative biotech remains on investing to continue to drive top-line growth and advance our pipeline. Moving to Slide 16. We ended the quarter with cash and marketable securities of $238.9 million as we produced positive cash flow from operating activities of $12.6 million for the period. We expect to maintain positive cash flow throughout the rest of the year. As we have stated previously, we intend to continue to invest the capital we generate back into our business to inflect growth in 2027 and beyond. We have total debt of $101.9 million. As Frank announced at the beginning of today's call, we are increasing our full year 2026 net revenue guidance to be between $525 million and $540 million.

Latha Vairavan
Latha Vairavan
CFO at Arcutis Biotherapeutics

This updated range contemplates the contribution of the new commercial initiatives Frank detailed today, as well as the continued strength of our core ZORYVE business. With that, I will now turn the call back to Latha for some final updates.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

All right. Thanks, Latha. We're also announcing today that Todd Edwards will resign from his role as Chief Commercial Officer at Arcutis to pursue other opportunities for personal reasons, effective later this month. I want to thank Todd for his leadership over these last three years. He's helped to build the commercial infrastructure that has enabled ZORYVE's success to this point, and that will continue to serve as the basis of ZORYVE's continued growth. I'm also delighted to announce that Rob Lisicky will be stepping in as the interim Chief Commercial Officer while we conduct a national search for a permanent CCO. Rob is a highly experienced biopharma executive with a career spanning 30 years in the industry. Most recently, Rob was the CEO at Zura Bio, and prior to that, he was Chief Commercial Officer at Arena Pharmaceuticals until its acquisition by Pfizer in 2022.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Before that, he was CCO at Daiichi Sankyo USA. Rob and I have known each other for decades from our time together working on ENBREL, and he brings a wealth of experience in leading best-in-class commercial teams in the inflammation and immunology space, and in driving rapid sales expansion to build blockbuster franchises. The expertise that Rob will contribute to our commercial operation at Arcutis is well-timed as we drive towards a period of continued and increasing sales inflection for ZORYVE in the near term. Q2 was yet another quarter of exceptionally strong execution by the Arcutis team. I am incredibly proud of the team and the dedication they demonstrate every day to advancing our mission, delivering value for shareholders, and remaining steadfastly committed to the patients we are serving today and aim to serve in the future. In early June, Arcutis celebrated its 10th anniversary.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

What started out as three guys and an idea has blossomed into a powerhouse biotechnology company with four FDA-approved products and a pipeline of promising programs and assets. More importantly, over the past decade, we have helped nearly a million people manage their chronic inflammatory disease, and we are poised to help millions more in the future. As I look back on the past decade, I am humbled by and deeply appreciative of the contributions of our team members, the dermatology clinicians who've partnered with us, the patients who agreed to participate in our trials, and the investors who believed in us enough to entrust their money to us. I sincerely thank you. With that, I'll open up the call to Q&A.

Operator

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. The first question will come from Seamus Fernandez with Guggenheim. Your line is open.

Seamus Fernandez
Seamus Fernandez
Analyst at Guggenheim

Oh, great. Thanks for the questions. Just wanted to start off, the guidance raise, definitely impressive. Frank, take your point to not expect updates to the guidance every quarter. Just in terms of the momentum into the back half of the year, where are you seeing the kind of key drivers of growth at this point? Really looks like the foam is just starting to truly stand out. Even the early sales of the 0.05% are coming on nicely. I just wanted to get a little bit of a better sense of how you're thinking about the back half of this year's growth trajectory, and where you see incremental opportunities from the access point that you're opening up via telehealth.

Seamus Fernandez
Seamus Fernandez
Analyst at Guggenheim

It seems like the telehealth opportunity could be quite substantial, but I guess we're all probably wondering where the price points are likely to end up on that front. Just as it relates to Todd's resignation, I think we saw in the 8-K that he's pursuing another opportunity away from Arcutis. It seems like the team is extremely well built at this point. The strategy has worked effectively, and you're transitioning to an interim leader who's got a great background. What is it that you're most focused on during this transition in particular?

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Yeah. Seamus, thanks for your questions. Let me start with the first one. Frankly, we continue to see growth across the portfolio. As you mentioned, the foam is our leading product. It is a really unique, highly differentiated asset. It's the only nonsteroidal in a foam. It effectively is the only foam available for doctors. It's very hard to get the topical foams these days. I think it's been something that doctors and patients have responded to extremely well. We see growth across the board. As you mentioned, the 0.05, it continues to grow very nicely. I think that speaks to the unmet need for good nonsteroidals in younger kids, it also points to the promise of 0.05 in the three to 24-month-olds, if we get the approval in February as we expect.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We would expect a continued growth across the portfolio in the second half of the year, primarily driven by demand growth. We may see some marginal incremental improvements in gross net, but I wouldn't expect anything dramatic given the strength of our gross nets already at this point in the year. I think as the year progresses, we're going to start seeing the impact of a variety of the initiatives that we've been talking about today. The derm expansion, I think we'll see kick in the second half of the year. I think it's probably too early for primary care, but I think in 2027, we'll see that. On the telehealth front, I think the majority of these patients are going to have access to ZORYVE through their insurance coverage. We've set up with the platform to allow patients to go that route.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

This is not like some of the other offerings out there today where the patient has to pony up the money themselves to pay for the product like, for example, the GLP-1s. Here, it would be just like if the patient was going in the doctor's office. The doctor is diagnosing the patient, choosing a therapy, and if they choose ZORYVE, and they don't have to choose ZORYVE, but it's a great choice for all three of these diseases. If they choose ZORYVE, that immediately kicks them into a work stream where we get the PA done, we get the insurance paying for the ZORYVE, and we ship it to the patient. The cost to the patient for ZORYVE is no different than if they went to the dermatologist's office. Let's see. Lastly, with regard to the transition.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Todd has built a very strong commercial leadership team. I think just in the last six months, we've added Katherine Swolfs to run the primary care effort. She's doing an outstanding job. We brought in Chris Kloc from AbbVie to lead the sales team. We have a really strong commercial team. I'm not the least bit worried about them managing our commercial performance through the transition. Rob will be starting before Todd's departure so that there's a seamless transition between the two of them. I couldn't think of a better person to be coming in and helping us, not only with ZORYVE, frankly, but with the pipeline as well, given Rob's background. Very excited to get to work with him again.

Seamus Fernandez
Seamus Fernandez
Analyst at Guggenheim

Great. Congrats. I'll jump back in the queue.

Operator

Thank you. The next question will come from Tyler Van Buren with TD Cowen. Your line is open.

Tyler Van Buren
Tyler Van Buren
Analyst at TD Cowen

Hey, guys. Thank you, and congrats on the solid quarter-over-quarter performance. A couple. First, just would it be reasonable to expect a similar quarter-over-quarter sales growth for the ZORYVE franchise in Q3 over Q2 as compared to Q2 over Q1 that we just saw? On vitiligo, given the upcoming data next quarter right around the corner, can you talk more about enrollment and the demand you guys have seen at sites and the demand for a topical option? Specifically, what data you want to see to move forward with this program and invest more?

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Sure. Latha, you want to take the first one, maybe Patrick, can you take the vitiligo question?

Latha Vairavan
Latha Vairavan
CFO at Arcutis Biotherapeutics

Yeah, I'll take it. Sorry, I had to unmute myself. Hey, Tyler. Thanks for the question. We expect continued quarter-over-quarter growth in our net sales. I wouldn't anchor you to any of this current quarterly run rate. I think you should anchor to the initiatives that we outlined and with the guide that we've given and what we expect to happen in the quarter. I think you'll be able to piece your way into what'll happen in the second half of the year. I don't want to give you the answer to the question on the growth rates, we do expect quarter-over-quarter net sales growth, Q3 versus Q2, and of course, naturally Q4 versus Q3. As Frank alluded to, we'll sort of moderate the gross net improvements, so everything will be volume and demand based.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

I can pick up the vitiligo study. As we mentioned, the vitiligo trial is fully enrolled. We were really happy with the enrollment pace for that. Keeping in mind that that was in pediatric patients as well that are oftentimes more difficult to enroll. I think that that bodes well for a future vitiligo program were that to materialize. Your question about what we're looking for. I think OPZELURA really has set a bar for a branded nonsteroidal in vitiligo. We think that there's a lot of room for us to compete there, right? There's essentially one other drug in this category. We think that we have, in some ways, really a superior product profile. We're talking about once-a-day dosing, eligible for adjunctive use.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

We anticipate that there will be some systemics that are going to be moving into this space as well, especially for the more severe patients. That would be something that we would think would be advantageous. Also no black box and pricing. These are a lot of the same features that make us very competitive in AD and our other indications as well. We really feel like even if we have equivalence on efficacy and rate of onset, that we're going to be very competitive here based on those factors. What we're really looking for is superiority on either of these two axes, especially on speed of onset. One of the reasons to potentially believe that is the PDE4 mechanism of action being based both on anti-inflammatory as well as potentially working directly on melanocytes.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

The fact that the mechanism of action, we've really seen some brisk responses based on being able to have such a potent PDE4 inhibitor. The rate of effect is someplace that we're also optimistic, but we'll have to obviously see those results when we come in at the end of the year with the readout for that.

Operator

Thank you. The next question is going to come from Judah Frommer with Morgan Stanley. Your line's open.

Judah Frommer
Judah Frommer
Analyst at Morgan Stanley

Yeah. Hi, guys. Congrats on the quarter. Thanks for taking the questions. Maybe could you provide a little more color on some trends within share of the branded topical nonsteroidal class, maybe specifically on new-to-brand trends that you're seeing? Separately, just curious on enrollment trends for the 234 trial. Obviously, a crowded space, but it seems like new mechanisms are in demand. Just curious how enrollment is tracking there. Thanks.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Sure. Thanks, Judah. With regard to trends in share, ZORYVE continues to be the leading branded nonsteroidal on the market, hovering just shy of 50% market share. ZORYVE is the primary product driving the growth of the class. Those are, as we talked about before, patients who are coming over from topical steroids. I think we've really just scratched the surface and, if anything, given the discussions in dermatology, that trend's likely to accelerate going forward. On the new-to-brand data, off the top of my head, I don't want to misspeak. I don't have those numbers right at my fingertips. Clearly, ZORYVE is doing very well competitively versus the other branded nonsteroidals. We expect that to continue. With regard to the enrollment trends, Patrick, again, could you maybe address that?

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

Yeah, absolutely. Just to remind, for 234, we're exiting the healthy volunteer section of our single ascending dose. We have a couple of cohorts of the single dose that are actually in atopic dermatitis, but otherwise healthy patients who also have atopic dermatitis. We're moving into those AD cohorts. We're also going to be initiating recruitment into the first multiple ascending dose. Those are all in atopic dermatitis patients. We don't have any experience yet from this trial in enrolling atopic dermatitis patients. I agree with your point that, especially with the departure of OX40 from the kind of pipeline and competitive landscape here for atopic dermatitis patients, that a new mechanism of action is something that is going to be very beneficial for our recruitment.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

I think that this mechanism in particular is one where there's going to be a lot of interest. It is a competitive space. There is a lot that's going on. I think that we're well-positioned to be able to recruit these trials. Thanks.

Operator

Thank you. The next question will come from Uy with Mizuho. Your line is open.

Uy Ear
Uy Ear
Analyst at Mizuho

Hey, guys. Thanks for taking our question. Maybe just help us understand about the change in gross net a little bit. I just want to make sure I understood you guys correctly.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Sorry, could you say that one more time? I didn't catch your question.

Uy Ear
Uy Ear
Analyst at Mizuho

I just wanted to see if you can help us understand the change in gross net a little bit as we go from this quarter to the Q3 and Q4. I guess in the first quarter you were saying to expect gross net to go to the low 50s towards the end of the year. Is that still the case or is it more steady now? My second question is, could you maybe elaborate a little more on the initiation of the PD-L1 study, side effect study? When do you expect it to finish? Is there going to be a go-to decision to move into phase III, or is it a study where you can publish and use the data to help with adoption? Thanks.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Okay. All right. Thanks. Yeah. Latha, you want to maybe take the gross net question on our view on gross net for the rest of the year? Patrick, can you talk a little bit more about the PD-L1 study?

Latha Vairavan
Latha Vairavan
CFO at Arcutis Biotherapeutics

Yeah. Hi, Uy. We do expect the gross net to be in the 50s throughout the year and titrate down to the low 50s, as we've said. We just think that the level of improvement will moderate. We started from a point that was lower than last year, even though it was in the higher 50s. I'm sure your math will show you the improvement that we experienced in Q2. There'll be some improvement in Q3 and Q4, not to the degree of last year, but it will come down to the low 50s.

Uy Ear
Uy Ear
Analyst at Mizuho

Okay. Thanks. That was helpful.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

Yeah. Just to kind of give a little more context to this study, I think your question really is on point with trying to understand what we're looking for here. We really see this not as necessarily a full development program. Really more of a way to create some data that can be helpful in order to ensure that patients may have access to this because there will be some data that will be published that will be out there, will give them another option. A lot of these patients are going directly into topical steroids as first line, they may need to be on them for many years. I think having additional data really for this patient population to keep them from having to abandon a therapy that is usually working for them.

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

It's really just about publishing, getting access to it, and not necessarily a full development program. The timing of the study is one that we'll obviously keep you posted as we get further into it, but it's just getting started now.

Uy Ear
Uy Ear
Analyst at Mizuho

Okay. Thank you.

Operator

Thank you. The next question will come from Andrew Tsai with Jefferies. Your line's open.

Matt Barcus
Matt Barcus
Analyst at Jefferies

Hey, good afternoon and congrats on the quarter. This is Matt Barcus on for Andrew Tsai at Jefferies. I just wanted to follow up on the revised guidance. Can you fundamentally talk about some of the push-pulls behind the continued growth and acceleration? Are you aware of any other investigator-sponsored or independent studies with ZORYVE that could be starting out over the next year? If so, can you just talk about the market opportunities there for each of those indications?

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Thanks for the question, Matt. With regard to the first question, I think that in the second half of the year, the primary driver of growth is going to be growth in prescriptions. As Latha just mentioned, we do expect to see some improvement in gross-to-net in Q3 and Q4, but probably moderated compared to what we saw in Q1 and Q2, and not being the major driver of growth. That demand growth is going to likely be a combination of the momentum that we already have generated and then the impact of a number of the commercial demand drivers that we've rolled out, like the sales force expansion, the continued DTC efforts, the virtual health platform that we just announced. All of these things are really synergizing to help us continue to drive the prescription growth for ZORYVE.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

On your second question with regard to IITs. We don't actually support a lot of investigator-initiated trials at Arcutis. The IIT process is pretty clunky, to be quite honest, and our preference is to do what are referred to as collaborative research studies, where the company is able to work with the investigators. A number of the studies that we mentioned, including the vitiligo trial, the HS trials, the nail psoriasis trial, the PD-L1 trial that Patrick was just mentioning, those are all collaborative research studies. As I mentioned earlier in my comments, we continue to explore other opportunities, other potential indications, and I think it's likely that we'll start at least one more of these proof of concept studies this year for another indication. Maybe more. We have more options probably than we have resources with 47 diseases having some efficacy data.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We're not going to pursue all of them either. I do think you'll probably see one or more start this year, and we very well may start some additional studies next year as well. These are really cost and time-efficient ways for us to get an evaluation of a potential indication and then enable us to make an informed decision about whether we want to actually pursue a large registrational study for that indication. Patrick, I don't know, any additional comments that you would want to add on that point?

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

No, I think that covers it, Frank. Thanks.

Matt Barcus
Matt Barcus
Analyst at Jefferies

I appreciate it. Thank you.

Operator

Thank you. Our next question will come from Serge Belanger with Needham. Your line's open.

Serge Belanger
Serge Belanger
Analyst at Needham

Hi, good afternoon, congrats on a nice quarter. First couple questions around the virtual health platform offering. Are you trying to target a different set of patients than what you're currently able to access, and will you be able to drive patients to this platform via DTC efforts?

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Yeah.

Serge Belanger
Serge Belanger
Analyst at Needham

Secondly-

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Okay.

Serge Belanger
Serge Belanger
Analyst at Needham

Go ahead.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

No, that's all right. Go ahead.

Serge Belanger
Serge Belanger
Analyst at Needham

I was going to ask, I believe I read that you were granted a couple new patents. I hope that was from your press release and not another one I read in the last hour. Just curious how it enhances the ZORYVE patent portfolio and whether those new patents are eligible for the Orange Book listing.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Yeah. Okay. With regards to your first question, yes, I do think of it as a different set of patients, right? The bulk of the patients that we're picking up today, really almost all of them, right, are patients who have already been seen by a dermatologist and are coming in for a refill or an annual checkup or in many cases, they're flaring because of their existing therapy isn't working and the doctor's looking to do something different for those patients. That's a patient that is already in the dermatology care system and has access to a dermatologist because they have an appointment, right? The advantage of the virtual health platform is like where I live, it's a six-month wait to see a dermatologist.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Even if you're in an acute situation, I had shingles a number of years ago, and it was going to be a month before I could see a dermatologist. When you have an urgent acute problem, you want to see someone like that day or the next day, right? That's just not practical in many places in the United States because of the mismatch between supply and demand of dermatology specialist care. There are also a lot of places in the country that just don't have dermatologists, right? For example, Patrick and I were in Roswell, New Mexico a couple of years ago. There isn't a dermatologist in 250 miles. For those patients, they just don't have that option to see a dermatologist.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We think that the virtual health platform is really going to complement the patients who are already seeing a dermatologist by allowing patients who don't have access to a dermatologist, either because of scheduling or geography, to see a dermatologist that day. Yes, to your earlier question, absolutely we think direct to consumer is an important driver here. If you think about it, a patient sees an interview with Tori or Max Homa, they have the disease as well, and they think, "Gee, I want to look into this more." They can go right to our website. There's a click right on the homepage. You click on it, and it pulls you straight into the platform where the dermatologist sit, and the patient is able to schedule a visit with the dermatologist right then and there.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

We think this is an important expansion of the opportunity set for ZORYVE, particularly, again, given some of the idiosyncrasies of dermatology in the U.S. On the new patents. There are two new patents that cover, one is the formulation and the other one is method of use. I can't say definitively, but it's likely that they are Orange Book listable. We have a very strong patent position around all of the ZORYVE formulations. We have I think 18 patents listed in the Orange Book at the moment. We continue to incrementally strengthen our IP portfolio. These aren't dramatically differentiated. They don't change the loss of exclusivity timelines of 37 for the cream and 42 for the foam. We're always looking to strengthen that already strong IP portfolio. These two patents are just the product of that overall effort.

Serge Belanger
Serge Belanger
Analyst at Needham

Got it. Thank you.

Operator

Thank you. The next question is going to come from Douglas Tsao with H.C. Wainwright. Your line is open.

Douglas Tsao
Douglas Tsao
Analyst at H.C. Wainwright

Hi. Good afternoon. Thanks for taking the questions. Just following up on the telehealth initiative. I'm just curious, Frank, what the conversion rate from an initial online intake to a prescription for ZORYVE. Are patients still needing to sometimes maybe do some kind of step at it, or have they typically gone through that already? Have you seen evidence of patients maybe going through initial intake, maybe having, because of their plan, needing to try a TCS and then coming back to ultimately still get a script for ZORYVE?

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Sure. Yeah. Thanks, Douglas. Great question. It's still very early days, right? I think we will have to see over time what kinds of patients flow into the system, and what happens. I think a couple points. The first one, again, is when the doctor, when the dermatologist is evaluating the patient, the dermatologist can choose any therapy for that patient. It doesn't have to be ZORYVE, obviously, right? We think ZORYVE is a great choice, but it doesn't have to be. If the patient has something other than one of our approved indications, they're obviously going to get something else as well. Many patients are on a topical steroid or have used a topical steroid before. I would expect that many of the patients that come into the telehealth platform will have been on a prior topical steroid and are looking for a non-steroidal alternative.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Maybe they've heard, again, Max or Stella or Tori talk about their experiences and their frustrations. Maybe they're afraid of topical steroids based on what they've read about topical steroid risks, and they want to look for something different. I think that many of the patients coming in are likely to have already been on a topical steroid. As I mentioned, we have the infrastructure in place to provide the insurance and fulfillment support for these telehealth patients that compares very favorably to what they would see if they went to a dermatologist's office. We're really looking at how we streamline this process, whether you're seeing a dermatologist in person or you're seeing them online. I think it's possible that some of the patients may end up needing to step through another product if they're a new onset patient.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Even in that scenario, with the issues related to topical steroids, those patients are likely to be coming back in the not too distant future to get ZORYVE after they've met the step requirement.

Douglas Tsao
Douglas Tsao
Analyst at H.C. Wainwright

Okay, great. That's really helpful.

Operator

Thank you. The next question will come from Ricard Lowe with Goldman Sachs Your line is open.

Tolani Uthman
Tolani Uthman
Analyst at Goldman Sachs

Hi, everyone. This is Tolani Uthman on for Rich. Thanks for taking our questions. The first one on the commercial front. As you guys think about launching the PCP and the pediatric sales teams for ZORYVE in the coming months, how many patients do you believe are not adequately referred to dermatologists from the PCPs and pediatricians? In other words, about how many patients do you think would be served by that new sales force?

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Sure. Yeah. Very good question. We know that about half of all patients with psoriasis, AD, and seb derm are not seen by a dermatologist. Right? That's very well established in the data. The majority of those patients are being seen by either a primary care doctor or a pediatrician. That's leaving aside patients who are not currently being actively treated. We don't really look at those patients because it's always difficult to mobilize patients who aren't in the system. Of patients currently receiving prescription therapy, about half of those patients are seen by non-dermatologists, the overwhelming majority being primary care and pediatricians. With this initial sales force, we're only calling on a fairly small chunk of the primary care and pediatric community.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

As I mentioned in my prepared remarks earlier, we are focusing on very high volume doctors who have a proclivity to adopt new therapies, in some cases, doctors who've actually written ZORYVE already. We think that's where we're going to get the fastest initial traction. Then as we evaluate and fine-tune our approach, get a sense of the return on investment from the primary care initiative, we'll evaluate how large this primary care sales force should be, how far into primary care and pediatrics we reach. That may evolve over time just as it did with the dermatology sales team as well. Early on, we're going to be focusing on a small piece of a very large pie. One of the statistics that we shared on a prior quarterly call is that there's something like 500,000 primary care providers in the U.S.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

It's a massive number. We're not going after 500,000 providers, obviously. It turns out that there are about 5% of those primary care doctors and pediatricians, so about 25,000 doctors, write a third of all the topical scripts that come out of primary care and pediatrics. There's a very, very rich vein of potential in the primary care and pediatric community of highly concentrated, higher volume doctors, that's really where we're going to be focusing our efforts initially and as we expand.

Tolani Uthman
Tolani Uthman
Analyst at Goldman Sachs

Okay. Really helpful. Thank you. Then one more on atopic derm specifically. How will the potential approval of ZORYVE in the infants, the three to 24-month, expand that market opportunity? What types of pre-launch activities, if any, are you guys pursuing to support a strong uptake in that setting?

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Yeah. We think it's going to be a very important catalyst. There are about 1 million patients in that age group, the three to 24-month, that have atopic dermatitis. It's a large market. The only things approved right now for three to 24-month-olds are, there's six of the topical steroids are approved in that age group, EUCRISA is approved in that age group, that's it. Doctors are either having to treat patients, these infants, off-label, or they're having to use one of those seven drugs that's approved. I think that's really why we're seeing so much excitement from especially the pediatric dermatology community, because they don't have very many options. They don't have good options, especially non-steroidal.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

They've all used ZORYVE already, they know how good it is, they're very excited to be able to use it in this very young population. Patrick can speak to this, too, but there's concerns around steroids for every patient, but they're particularly acute in this 3 to 24-month population. No parent wants to put their kid on steroids, quite honestly, right? If we're able to offer a really effective and very safe and well-tolerated non-steroidal option to treat those patients, we think we're going to see very, very meaningful uptake in that population. Patrick, anything that you would add to that?

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

Yeah, I think you're absolutely right. What that kind of steroid avoidance leads to is some real challenges in, I think the best place to see this is in the pediatric dermatology community. Frank, I know you were just at the Society for Pediatric Dermatology meeting. Even going back last year when we were there was already tremendous awareness of this study going on, even before we had the data, an interest in getting it to their patients because of these very few treatment options that Frank outlined. Now having the data out there, having it already been presented at the AAD, the activities that we have are really sitting within the medical affairs team and just kind of reacting to a lot of the questions and interest in what do our data show?

Patrick Burnett
Patrick Burnett
Chief Medical Officer at Arcutis Biotherapeutics

How is this similar or different to what we have with the ages two and above, particularly in atopic dermatitis? Just really making sure that everybody is getting their questions answered as we kind of prepare and move towards that launch in the beginning of next year.

Tolani Uthman
Tolani Uthman
Analyst at Goldman Sachs

Makes sense. Thank you.

Operator

Thank you. I show no further questions in the queue at this time. I will now turn the call back to Frank for closing remarks.

Frank Watanabe
Frank Watanabe
President and CEO at Arcutis Biotherapeutics

Before I close, this is real-time service here. Serge, I have an answer to your question and a correction. I misstated. We have 28 patents, not 18 patents on ZORYVE. Mas, our general counsel, corrected me, and he did confirm that both of these new patents are also Orange Book listable. I wanted to clarify that. Yeah. Listen, another great quarter. Really appreciate everyone taking your time to call in today. I know it's a very, very busy time of the year with everyone doing quarterly results, and we appreciate your time and attention and all the great questions, and we look forward to talking to everyone again at the Q3 call. Thanks. Bye-bye.

Operator

This concludes today's conference call. Thank you for participating, and you may now disconnect.

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