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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)

Metric (USD)Q4 2023Q3 2024Q4 2024
Total Revenues$13.526M $44.755M $71.360M
Product Revenue, net$13.526M $44.755M $69.360M
Other Revenue$0 $0 $2.000M
Cost of Sales$2.246M $5.503M $6.905M
R&D Expense$23.775M $19.501M $14.480M
SG&A Expense$48.674M $58.817M $57.607M
Net Loss($66.284M) ($41.537M) ($10.788M)
Net Loss per Share($0.72) ($0.33) ($0.09)

Notes: Q4 2024 product revenue includes a non‑recurring $4.1M reserve reduction; excluding this, product revenue ≈$65.3M .

Balance Sheet & Cash Flow Highlights

MetricQ4 2023Q4 2024
Cash & Cash Equivalents$88.398M $71.335M
Marketable Securities$183.463M $156.620M
Cash, Cash Equivalents, Restricted, Marketable$272.8M $228.6M
Long‑term Debt, net$201.799M $107.203M
Net Cash Used in Operating Activities (Q4)N/A$0.7M

KPIs and Operating Metrics

KPIQ3 2024Q4 2024Commentary
Weekly Scripts (rolling)~11,000 ~16,000 +44% q/q; +334% y/y
Blended Gross‑to‑NetLow 50s Low 50s; steady state Seasonally higher in Q1
Refill RatesN/A~40% PsO cream; ~38% foam AD refills still early
Medicaid Coverage~4 in 10 Americans (by state coverage) ~1 in 2 Medicaid beneficiaries CA first‑line (no step edit)

Q4 2024 vs. Preannouncement

MetricPreannounced (Jan)Actual Q4 2024Notes
Net Product Revenue~$63M (unaudited) $69.360M Includes $4.1M non‑recurring adjustment
Net Product Revenue ex‑adjustmentN/A~$65.3M CFO: exclude for forward models

Q4 2024 vs. Street Estimates

MetricConsensus (S&P Global)ActualSurprise
RevenueUnavailable at time of analysis$71.360M N/A
EPSUnavailable at time of analysis($0.09) N/A

S&P Global consensus data were unavailable due to API limits at the time of retrieval.

Guidance Changes

MetricPeriodPrevious Guidance/CommentaryCurrent Guidance/CommentaryChange
Revenue outlookFY 2025N/A“Comfortable” with ~$280–$285M consensus; emphasize intra‑year seasonality in Q1 New color (endorsed consensus)
Gross‑to‑Net2025Low 50s (approaching steady state) Steady state in the “50s”; Q1 at higher end due to deductibles Maintained with seasonal nuance
Cash Flow2026Break‑even target 2026 (prior commentary) Reiterated break‑even in 2026 Maintained
SG&A2025Q4 to be roughly in line with Q3 (ex‑Kowa commission) SG&A to increase in 2025 to support launches and marketing Raised
Interest Expense2025N/ALower in 2025 due to $100M debt prepayment Improved
Regulatory2025Foam scalp/body psoriasis PDUFA May 22, 2025 Unchanged; still May 22, 2025 Maintained
Regulatory (AD ages 2–5)2025sNDA planned for early 2025 sNDA submitted Dec 16, 2024; anticipated Q4 2025 action if accepted Progressed

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Shift away from topical steroidsHighlighted opportunity; ZORYVE profile for chronic use Positioning ZORYVE as #1 branded topical new Rx; steroid conversion key Growing clinician push to reduce steroid reliance; strong ZORYVE fit Strengthening
Payer access & GTNGTN improved to high 50s; PBM coverage strong Blended GTN low 50s; Medicaid wins in 7 states GTN steady in 50s; Medicaid ~1 in 2 beneficiaries; Medicare Part D progressing (IRA delays) Improving; Part D slower
Kowa co‑promote (PCP/Peds)Announced (late July); meaningful 2025 contribution expected Began mid‑Sept; 2024 immaterial; meaningful in 2025 2024 minimal; 2025 contribution expected; SG&A includes commissions Building
Demand scripts & refillsScripts near 10k weekly; refill ~38–40% emerging ~11k weekly scripts ~16k weekly; refills ~40% PsO cream/~38% foam Accelerating
Regulatory catalystsFoam sNDA filed; AD 2–5 sNDA planned; ARQ‑255 H1’25 Foam sNDA accepted; PDUFA May 2025 PDUFA May 22, 2025; AD 2–5 sNDA submitted; IND for ARQ‑234 in 2025 On track
Consumer marketingLimited DTC; TV evaluated due to economics N/AOBJ partnership for seb derm awareness; low double‑digit millions spend Expanding
Capital/LeverageDebt amended; option to prepay/redraw $100M prepay in Oct; interest down Interest lower in 2025; cash break‑even in 2026; no equity raise expected Improving
Legal/IPN/AN/AMarkman hearing in Apr 2025; confident in IP New risk disclosure

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: