Arcutis Biotherapeutics Touts ZORYVE Expansion, New Indications and 2026 Cash-Flow Breakeven Goal

Key Points

• ZORYVE is being positioned as a multi‑indication franchise (psoriasis, atopic dermatitis, seborrheic dermatitis) with pediatric expansion—approved to age 2 and showing 58% EASI‑75 in 3–24 month data—backed by a ~160‑rep salesforce and a plan to capture ~15–20% of the topical market for peak sales of $2.6–$3.5 billion (including a risk‑adjusted $300–$500M lifecycle contribution).
• Arcutis said it reached cash‑flow breakeven in the fourth quarter (already passed) and expects to remain sustainably cash‑flow breakeven through 2026, with savings to be reinvested into commercial initiatives.
• The company is pursuing new indications with small open‑label studies—vitiligo (planned Q4) and hidradenitis suppurativa (planned Q1)—and is advancing ARQ‑234, a CD200R agonist aimed at TH2‑oriented diseases with potential for durable, patient‑friendly dosing.

Executives from Arcutis Biotherapeutics NASDAQ: ARQT outlined their commercial priorities for the ZORYVE franchise, discussed potential label-expansion opportunities, and provided updates on pipeline and business development strategy during a conversation at Guggenheim Securities’ Emerging Outlook Biotech Conference.

Commercial strategy: expanding ZORYVE across indications and age groups

Chief Financial Officer Latha Vairavan said the company’s outlook is centered on growing and expanding ZORYVE while also building out the pipeline. She framed ZORYVE as a product franchise spanning multiple inflammatory skin diseases—psoriasis, atopic dermatitis, and seborrheic dermatitis—across “various strengths and formulations” intended to treat patients “of all ages.”

To support growth, Vairavan said Arcutis is making commercial investments, working through access dynamics, and focusing on marketing. She also pointed to planned label-expansion work in areas previously discussed by the company, including nail psoriasis and scarring alopecia.

Cash flow and 2026 outlook

Vairavan said Arcutis provided guidance “for the first time” and stated the company would be cash-flow breakeven starting in the fourth quarter, which she said has now passed. She added that the company expects to remain sustainably cash-flow breakeven throughout 2026.

Shift away from topical steroids: physician and guideline momentum

Chief Medical Officer Patrick Burnett discussed what he described as changing attitudes in dermatology around long-term topical corticosteroid use and the prospect of managing patients without steroids. He said Arcutis has data indicating that patients on long-term topical corticosteroids can develop systemic effects similar to those seen with repeated oral use over time, which he suggested is contributing to interest in non-steroidal options.

Burnett also said the field is seeing a “tremendous shift” in optimism among patients and providers, helped by both systemic therapies and topical options that enable treatment across multiple inflammatory skin diseases. On guidelines, he cautioned that formal updates can lag clinical practice, but said messaging from speakers at American Academy of Dermatology meetings has been shifting, and that topical treatment guidelines—particularly in atopic dermatitis—are beginning to reflect a push toward therapies that are suited for chronic, long-term use.

Pediatric opportunity and new data

Burnett highlighted the pediatric atopic dermatitis opportunity and noted that ZORYVE is currently approved down to age 2 for atopic dermatitis. He discussed data in younger patients, describing results in the 3- to 24-month age range where he said the company observed 58% of patients achieving EASI-75.

He characterized the early pediatric setting as an area where families may have heightened concern about using topical corticosteroids, and said Arcutis views ZORYVE’s tolerability and safety profile as a fit for that population. Burnett also estimated that nearly 1 million patients in the 3- to 24-month-old range are being treated for atopic dermatitis.

Peak sales framework, salesforce expansion, and future indications

Vairavan reiterated the company’s peak sales opportunity range of $2.6 billion to $3.5 billion and said it includes $300 million to $500 million from a future life-cycle-management expansion indication, naming hidradenitis suppurativa (HS) or vitiligo as examples. Excluding that contribution, she described a $2.3 billion to $3.0 billion opportunity driven by share gains from topical steroids.

She said Arcutis currently has about a 3% share of the overall topical space and leads among non-steroidal topical products, and that its peak sales framework assumes reaching roughly 15% to 20% share over time. She also described two commercial pathways: dermatology as the primary driver and a secondary effort that includes pediatrics and primary care.

On field expansion, Vairavan said the company added 30 representatives earlier in the year and now has about 160 field-facing representatives. She said Arcutis has had more than 18,000 unique prescribers and is focused on increasing prescribing depth, arguing that prescribing across more than one indication can drive outsized growth versus a single indication.

She also said Arcutis terminated a partnership in late January that had been focused on primary care and pediatrics, and plans to build a targeted primary care team of about 25 to 30 people that will operate separately from the dermatology sales effort.

Burnett discussed how the company evaluates possible new indications by monitoring real-world physician experience, including off-label use that is later discussed in publications or at meetings. He said Arcutis has tracked use across “40+ indications” and highlighted vitiligo and HS as areas where physicians reported encouraging signals, including what he described as a surprisingly rapid onset of efficacy in vitiligo. He said Arcutis is conducting small open-label topical studies (typically 10 to 20 patients) to guide “go/no-go” decisions, with vitiligo planned for the fourth quarter of this year and HS in the first quarter of next year. Both Burnett and Vairavan emphasized that the $300 million to $500 million life-cycle-management contribution embedded in the peak sales range was “risk adjusted.”

Burnett also provided an overview of ARQ-234, describing it as a CD200R agonist intended to modulate an immune checkpoint by “resetting the thermostat” of the immune system rather than causing broad immune suppression. He suggested the mechanism could potentially enable durable effects and patient-friendly dosing, and said genetic data supported a focus on TH2-oriented disease biology, while noting potential interest in areas such as asthma and other conditions as the company learns more.

Finally, Vairavan said Arcutis intends to reinvest leverage from achieving cash-flow breakeven into commercial initiatives. She cited continued marketing efforts and said the company has used “Tori Spelling” as part of efforts to influence and market the product.

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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