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Arcutis Biotherapeutics, Inc. (ARQT)·Q4 2024 Earnings Summary
Executive Summary
- Q4 2024 total revenue was $71.4M, with net product revenue of $69.4M (+55% q/q; +413% y/y), including a non‑recurring $4.1M reduction in product return reserves; underlying product revenue was ~$65.3M excluding the adjustment .
- Net loss narrowed to ($10.8M), or ($0.09) per share, versus ($66.3M), or ($0.72) a year ago; cash and marketable securities totaled $228.6M at year‑end; net Q4 operating cash burn was ~$0.7M .
- Management reiterated blended gross‑to‑net in the “50s” (seasonally higher in Q1), and remains “comfortable” with 2025 revenue consensus of ~$280–$285M; cash flow break‑even targeted in 2026, aided by a $100M debt prepayment in Oct 2024 that reduces 2025 interest expense .
- Strategic catalysts: PDUFA May 22, 2025 for ZORYVE foam in scalp/body psoriasis; sNDA filed for ZORYVE cream 0.05% in ages 2–5 with anticipated Q4 2025 action; Medicaid coverage now ~1 in 2 beneficiaries; launch of OBJ awareness initiative in seb derm .
What Went Well and What Went Wrong
What Went Well
- Strong top-line momentum: net product revenue grew 55% q/q to $69.4M (46% excluding the $4.1M non‑recurring item), driving total revenue of $71.4M; y/y growth 413% .
- Access and GTN: blended gross‑to‑net reached steady state in the “50s,” supported by commercial and expanding government coverage; Medicaid access now covers ~1 in 2 beneficiaries, with no step edit in CA Medi‑Cal and favorable positioning in FL relative to Vtama .
- Demand KPIs: ZORYVE weekly scripts reached ~16,000 in Q4 (+44% q/q; +334% y/y), with refill rates ~40% (psoriasis cream) and ~38% (foam); brand unaided awareness improved across indications .
- Balance sheet de‑risking: $100M term‑loan prepayment to cut 2025 interest expense; year‑end cash/marketable securities of $228.6M and minimal Q4 operating cash burn (~$0.7M) .
- Management confidence: “we are well positioned to achieve further strong revenue growth” and “line of sight to break‑even in 2026”; comfortable with 2025 revenue consensus .
What Went Wrong
- Quality of revenue: Q4 included a non‑recurring $4.1M benefit from lower product return reserves; CFO emphasized excluding this item for forward calculations ($65.3M underlying product rev) .
- Profitability still negative: Q4 net loss of ($10.8M) and SG&A of $57.6M remain elevated to support launches; management guided to higher SG&A in 2025 with incremental marketing and launch activities .
- Q1 seasonality and coverage timing: GTN expected at the high end of the “50s” in Q1 due to deductible resets; Medicare Part D progress slowed by IRA operational impacts, pushing some access milestones into 2025 .
- Legal overhang: upcoming Markman (claim construction) hearing in April 2025 in ongoing IP litigation creates uncertainty; management asserted confidence in IP strength but cannot provide details .
Financial Results
Consolidated P&L (Oldest → Newest)
Notes: Q4 2024 product revenue includes a non‑recurring $4.1M reserve reduction; excluding this, product revenue ≈$65.3M .
Balance Sheet & Cash Flow Highlights
KPIs and Operating Metrics
Q4 2024 vs. Preannouncement
Q4 2024 vs. Street Estimates
S&P Global consensus data were unavailable due to API limits at the time of retrieval.
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “We continued our strong sequential revenue growth… revenues of $71M, with $69M from the ZORYVE franchise… Blended gross‑to‑nets have reached steady state in the 50s…” – CEO Frank Watanabe .
- “We have now secured Medicaid coverage in states that represent approximately 1 in 2 Medicaid beneficiaries… gross‑to‑net will be in the 50s throughout 2025.” – CCO Todd Edwards .
- “Excluding [the] nonrecurring adjustment, we had net product revenues of $65.3 million for the fourth quarter… we believe that we will reach cash break-even in 2026.” – CFO David Topper .
- “We anticipate the indication [for foam] to be inclusive of all psoriasis, but then also specifically calling out scalp…” – CMO Patrick Burnett .
Q&A Highlights
- Revenue delta vs preannouncement: Q4 preannounced ~$63M; actual beat largely due to ~$4.1M reserve reduction; ~$1M related to Q4 proper; remainder conservative preannounce .
- 2025 outlook: Management “very comfortable” with ~$280–$285M full‑year consensus; cautioned Q1 GTN seasonality when distributing revenue across quarters .
- Kowa contribution: 2024 immaterial; 2025 expected to be meaningful; commissions included in SG&A and paid only on generated scripts .
- Medicare/Medicaid: Medicaid at ~1 in 2 beneficiaries with high‑quality access (e.g., CA no step edit); Medicare Part D progressing but IRA slowed PBM operations .
- Foam in psoriasis: Expect broad indication inclusive of scalp; cannibalization of cream unlikely—growth expected for total ZORYVE psoriasis portfolio .
- IP: Markman hearing set for April 2025; management confident in IP position, limited comment beyond public docket .
Estimates Context
- Q4 2024: S&P Global consensus for revenue and EPS was unavailable at the time of this analysis due to data access limits; cannot compute beat/miss vs Street.
- FY 2025: Management stated comfort with consensus revenue of ~$280–$285M and advised modeling seasonality with higher gross‑to‑net in Q1; implication is stable full‑year trajectory with intra‑quarter fluctuations .
- Adjustments for models: Exclude the $4.1M non‑recurring reserve reversal from Q4 run‑rate; consider higher SG&A in 2025 for launches/marketing and lower interest expense post debt prepayment; maintain blended GTN in the 50s with Q1 at the high end .
Key Takeaways for Investors
- Underlying demand is accelerating across the ZORYVE portfolio with scripts at ~16k weekly and refill rates approaching ~40%, supporting a strong 2025 setup despite Q1 seasonality .
- Q4 revenue quality includes a non‑recurring $4.1M benefit; use ~$65.3M as a cleaner Q4 product revenue base for trend modeling .
- Access remains a structural tailwind: commercial stable; Medicaid now ~50% beneficiary coverage with favorable policies; Medicare Part D expected to phase in through 2025 as IRA headwinds ease .
- 2025 catalyst path is clear: foam scalp/body psoriasis PDUFA on May 22, 2025 and potential AD label expansion to ages 2–5 in Q4 2025, which could broaden prescriber adoption and Kowa contribution .
- Financial de‑risking: $100M debt prepayment reduces 2025 interest; mgmt targets cash break‑even in 2026 and does not anticipate equity financing for the existing business .
- Competitive narrative: Physician sentiment is shifting away from chronic steroid use; ZORYVE’s efficacy, tolerability, and once‑daily convenience position it to take share across three major inflammatory dermatology indications .
- Watch items: Q1 GTN/volume seasonality, SG&A increases for launch/marketing, Medicare Part D ramp timing, and April 2025 Markman hearing on IP .
Additional Relevant Press Releases (Q4 2024)
- Dec 16, 2024: sNDA submitted for ZORYVE cream 0.05% for ages 2–5 in AD; pivotal data showed vIGA‑AD success 25.4% vs 10.7% vehicle at Week 4 and favorable tolerability; expected action in Q4 2025 if accepted .
- Oct 18, 2024: Health Canada approval of ZORYVE foam for seborrheic dermatitis; U.S. foam sNDA for scalp/body psoriasis accepted with PDUFA May 22, 2025 .
Citations:
- Q4 2024 8‑K press release and financials:
- Q4 2024 earnings call transcript:
- Q3 2024 8‑K and call:
- Q2 2024 call:
- Dec 16, 2024 sNDA press release: