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ARQT

Arcutis Biotherapeutics, Inc.

Arcutis Biotherapeutics, Inc. Q4 FY2024 earnings call

February 25, 2025 · fiscal period ended 2024-12

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Summary

Generated 2025-02-25

Management highlights

  • Strong execution in 2024 with launches of ZORYVE foam for seborrheic dermatitis and ZORYVE foam 0.15% cream for atopic dermatitis, and expanded patient access. - In 2025, plans include expanding ZORYVE's approved indications, growing the prescriber base beyond dermatology, penetrating government payers, and taking market share from topical steroids. Anticipate May 22, 2025, PDUFA date for scalp and body psoriasis indication. - Fourth quarter ZORYVE net product revenue was $69.4M (+46% Q/Q), full-year ZORYVE product sales were $167M (+471% YOY). - Tailwinds for 2025 include educating physicians, engaging government payers, Kowa partnership, and taking market share from topical steroids. - ZORYVE had a record high weekly prescription volume of 16,000 in Q4. - High unaided awareness for ZORYVE in psoriasis, seb derm, and atopic dermatitis, with partnership with Odell Beckham Jr. to promote ZORYVE foam.
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Segment performance

In the fourth quarter, Arcutis Biotherapeutics generated revenues of $71 million, with $69 million coming from the ZORYVE franchise. Annually, total revenues were $197 million, and ZORYVE product sales amounted to $167 million, representing a 471% year-over-year growth. ZORYVE contributed 87.5% of the fourth quarter revenues ($69M/$71M) and 84.7% of the annual revenues ($167M/$197M). The blended gross-to-nets have reached steady state in the 50s, though there may be quarterly fluctuations related to patient deductibles.

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Guidance

  • 2025 expects substantial revenue growth with continued momentum in ZORYVE sales. - First quarter gross-to-net may be affected by patient deductibles and insurance plan changes but expected to return to steady state. - Annual run rate of ZORYVE product sales was ~$250M in 2024, expecting further growth in 2025. - Aim for cash break-even in 2026.
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Risks

  • IP lawsuits and potential impact on protecting ZORYVE's intellectual property. - First quarter gross-to-net variability due to patient deductibles and insurance plan changes. - Dependence on successful launches and approvals, including the May 2025 PDUFA date for psoriasis indication.
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Q&A highlights

Q: Clarify delta between preannouncement and actual 4Q results, related to inventory or other factors.

A: Adjustment for product return reserves, with part due to conservative preannouncement.

Q: IP protection confidence in ZORYVE franchise.

A: Confident in IP portfolio, will vigorously defend rights.

Q: Impact of sales force expansion on prescription growth.

A: Sales force expansion increased share of voice, driving prescription growth.

Q: Medicare and Medicaid coverage for ZORYVE.

A: 1 in 2 Medicaid beneficiaries have access, progress in Medicare Part D negotiations.

Q: Phase Ib data for ARQ-255 and psoriasis indication for ZORYVE foam.

A: ARQ-255 Phase Ib focuses on safety/tolerability; psoriasis indication broad, strategy to provide optionality.

View in transcript ↓

Key numbers

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Transcript

February 25, 2025

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