Arcutis Biotherapeutics (NASDAQ:ARQT) executives said ZORYVE continues to post strong growth and outlined several regulatory and clinical catalysts expected over the next year, while emphasizing that the company has reached a self-sustaining financial position.
Frank, Arcutis’ CEO, said the company believes ZORYVE remains in the “very early stages of growth” and reiterated its view that the product could ultimately generate $2.5 billion to $3 billion in peak sales. He said Arcutis has achieved cash-flow positive status, allowing it to keep investing in approved ZORYVE indications while restarting broader research and development efforts.
Regulatory and clinical catalysts ahead
Frank said the nearest expected catalyst is a potential FDA approval for ZORYVE in psoriasis patients ages 2 to 5, with a PDUFA date of June 29. Arcutis has also filed for approval of ZORYVE for atopic dermatitis in patients ages 3 to 24 months, though it has not yet received a PDUFA date. Frank said the company expects that decision “probably early next year.”
The company is also studying ZORYVE in new indications. Frank said Arcutis expects results from a Phase 2 vitiligo study by the end of this year and results from two Phase 2 hidradenitis suppurativa, or HS, studies in the early part of next year.
- Psoriasis in ages 2 to 5: FDA PDUFA date of June 29
- Atopic dermatitis in ages 3 to 24 months: approval expected potentially early next year
- Vitiligo Phase 2 data: expected by year-end
- HS Phase 2 data: expected early next year
Executives downplay inflation impact on access
The moderator noted that Arcutis’ most recent quarter showed sales up 65% year over year but down 17% quarter over quarter, with the company previously citing seasonal effects and severe weather. Asked whether inflation and other macroeconomic pressures could affect patient access, Frank said he does not expect an acute effect on Arcutis.
He said commercially insured patients generally have co-pays reduced to zero if their plan covers ZORYVE and to $35 if it does not. Medicaid patients typically pay $10 to $15 per prescription, he said, while Medicare is not yet a major source of business for the company.
Frank also said the company is in a better position on gross-to-net trends than last year and better than expected. Latha Vairavan, Arcutis’ CFO, said demand picked up in March and that the company is seeing “strong volume growth” in the second quarter to date compared with the first quarter. She said there is no signal of unusual co-pay card use in the second quarter.
Commercial strategy includes primary care pilot and Medicare growth
Arcutis is building an in-house primary care and pediatric effort after separating from Koa Bio. Frank said the company is starting with 20 sales representatives in major metropolitan areas, focused on high-volume primary care physicians and pediatricians. He described the effort as a pilot to understand how best to market ZORYVE outside dermatology.
Frank said selling into primary care is different because skin diseases represent a smaller share of those physicians’ practices, access can be more challenging and the selling cycle may be longer. He added that specialty pharmacies will be important in helping primary care offices process insurance and ensure patients receive prescriptions.
On Medicare, Frank said ZORYVE now has access to about one-third of Medicare lives through two large plans. He said Medicare’s annual deductible structure can make the first part of the year more challenging, but he expects Medicare to become an important growth driver over time. He said additional Medicare coverage updates could potentially come when formularies change in January, with announcements possible on the company’s fourth-quarter call.
ZORYVE expansion focuses on steroid conversion
Frank said the largest growth driver for ZORYVE is conversion from topical steroids. He said there are 25 million prescriptions written annually across the company’s three current main indications, including 16 million topical steroid prescriptions last year and 1 million branded non-steroidal prescriptions.
He said most commercial and Medicaid patients face only a single step through a topical steroid, which he does not view as a major barrier because most patients have already used steroids. Frank also pointed to new American Academy of Dermatology pediatric atopic dermatitis guidelines, which he said state that dermatologists should prefer nonsteroidal treatments over steroids because of long-term safety issues.
In seborrheic dermatitis, Frank said ZORYVE has changed dermatologists’ willingness to treat the condition because of its efficacy, itch relief, ease of use and chronic safety profile. He cited an 80% response rate at eight weeks in the company’s seborrheic dermatitis data, with 50% of patients completely clear at eight weeks and separation on itch at 48 hours.
Frank also highlighted ZORYVE foam as an opportunity in scalp psoriasis, saying there are limited options for that form of psoriasis and that it does not respond well to biologic therapy.
Pipeline includes ARQ-234 checkpoint agonist
Arcutis also discussed ARQ-234, a CD200 checkpoint agonist being developed for atopic dermatitis. Frank described the mechanism as the opposite of checkpoint inhibitors such as KEYTRUDA or OPDIVO, saying checkpoint agonism is intended to down-regulate immune activity by returning activated immune cells to an inactive state.
The company is in the single ascending dose portion of a Phase 1 study and expects to move into multiple ascending dose testing. Frank said Arcutis has not provided a data timeline because it will depend on the maximum tolerated dose and how many cohorts the company can complete.
Vairavan closed by saying Arcutis is executing on the strategy it outlined at its investor day last year. “We are self-sustaining, investing in that growth,” she said, adding that the company remains excited about ZORYVE label expansions and its pipeline.
About Arcutis Biotherapeutics (NASDAQ:ARQT)
Arcutis Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for immuno-inflammatory skin diseases. The company’s research and development efforts center on targeted treatments that address the underlying biology of conditions such as plaque psoriasis, atopic dermatitis, seborrheic dermatitis and vitiligo. Arcutis employs a precision-medicine approach to deliver topical therapies designed to improve efficacy and tolerability compared with existing treatment options.
In August 2022, Arcutis received U.S.
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