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Day One Biopharmaceuticals, Inc. (DAWN)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 marked Day One’s first quarter of commercial revenue, with OJEMDA net product revenue of $8.19M in its initial ~2 months; net loss narrowed sharply to $4.41M, aided by the $108.0M sale of the FDA Priority Review Voucher .
  • Launch KPIs were strong: ~75% of net revenue driven by patient demand (vs ~25% inventory), 157 patient starts (46% new; 54% EAP transitions), and broad early payer approvals across commercial and Medicaid, supporting durable uptake trajectory .
  • Strategic catalysts: Ipsen ex‑U.S. licensing (≈$111M upfront cash and equity at a premium, plus milestones and mid‑teens tiered royalties), oversubscribed $175.0M private placement, and pipeline expansion with DAY301 (PTK7 ADC), which is expected to enter the clinic in 4Q24/1Q25 .
  • No formal quantitative guidance issued; Street consensus from S&P Global was unavailable at time of analysis (API limit). We therefore cannot mark explicit beats/misses versus estimates for Q2 2024; qualitatively, early launch revenue and the Ipsen deal are likely estimate‑positive signals for outer quarters .

What Went Well and What Went Wrong

What Went Well

  • “Outstanding quarter” across the business with strong early OJEMDA demand post‑approval, reflecting robust commercial execution and patient access initiatives .
  • Ipsen ex‑U.S. license adds non‑dilutive capital and global commercialization leverage: ≈$111M upfront (cash + equity at a premium), up to ≈$350M milestones, and tiered double‑digit royalties starting in mid‑teens on net sales .
  • Launch KPIs: 157 patient starts in Q2, strong payer approvals (>80% commercial, >70% Medicaid), and ~75% of net revenue from demand vs ~25% inventory supporting healthy channel dynamics .

What Went Wrong

  • R&D expense spiked to $92.1M in Q2 (+$59.9M YoY), driven primarily by the $55.0M DAY301 (MabCare) upfront; while strategic, this weighs on near‑term P&L .
  • Pimasertib program closed in July 2024, removing a combination therapy option and narrowing near‑term adult pipeline optionality; management is redirecting resources to DAY301 .
  • No quantitative revenue/EPS guidance issued; investors lack near‑term official targets, which may add forecast dispersion until more launch data accumulates .

Financial Results

Quarterly Comparison (oldest → newest)

MetricQ4 2023Q1 2024Q2 2024
Product Revenue, Net ($USD Millions)$0.00 $0.00 $8.19
Cost of Product Revenue ($USD Millions)N/AN/A$0.71
R&D Expense ($USD Millions)$37.30 $40.21 $92.11
SG&A/G&A Expense ($USD Millions)$22.20 $26.56 $30.19
Net Loss ($USD Millions)$54.50 $62.41 $4.41
Net Loss per Share ($USD)N/A$(0.72) $(0.05)
Cash, Cash Equivalents & ST Investments ($USD Millions)$366.35 $317.94 $361.87

Notes:

  • Q2 2024 Net Loss benefited from $108.0M PRV sale; Investment Income was $3.96M .
  • Q1 2024 had no product revenue; OJEMDA was approved in April 2024 with first prescriptions beginning then .

Year‑over‑Year (Q2 2024 vs Q2 2023)

MetricQ2 2023Q2 2024YoY Δ
Product Revenue, Net ($USD Millions)$0.00 $8.19 +$8.19M
R&D Expense ($USD Millions)$32.18 $92.11 +$59.93M
SG&A Expense ($USD Millions)$17.07 $30.19 +$13.12M
Net Loss ($USD Millions)$45.86 $4.41 +$41.45M (improvement)
Net Loss per Share ($USD)$(0.61) $(0.05) +$0.56 (improvement)

Drivers:

  • YoY OpEx increases reflect the MabCare/DAY301 upfront, launch/commercial buildout, and trial activities; net loss improvement driven by PRV sale .

KPIs (Q2 2024 Launch Metrics)

KPIValueDetail/Source
OJEMDA Net Revenue Mix~$6.1M demand / ~$2.1M inventory~75% demand / ~25% inventory within $8.2M net revenue
Patient Starts15746% new starts; 54% EAP transitions
Payer Mix59% commercial / 38% MedicaidHigh early approval rates despite limited published coverage
Coverage Approvals>80% commercial; >70% MedicaidInternal prescription data/programs support early access

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue/EPSFY/Q3 forwardNot providedNot providedMaintained (no formal guidance)
OpEx (R&D/SG&A)FY 2024Not providedNot providedMaintained (no formal guidance)
OJEMDA Ex‑U.S. StrategyMulti‑yearN/AIpsen ex‑U.S. license: ≈$111M upfront, ≈$350M milestones, tiered mid‑teens+ royaltiesNew framework (strategic partnership)
DAY301 (PTK7 ADC)1H 2025IND cleared; timing TBDFirst patient dosing targeted 4Q24/1Q25Timeline specified (advancing)
Pimasertib Program2024Ongoing (FIRELIGHT‑1)Program closed; resources redirected to DAY301Lowered/terminated

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
Regulatory/ApprovalPDUFA date April 30, 2024; commercial readiness Post‑approval launch; first U.S. net revenue Transition from readiness to commercial execution
Commercial Launch ExecutionFirst prescriptions underway; building field team and support programs Strong demand, 157 starts, high payer approvals, demand‑heavy revenue mix Improving breadth and depth; early momentum
R&D Execution (OJEMDA trials)FIREFLY‑2 enrollment; +90 sites FIREFLY‑2 >100 sites; additional analyses to be presented Ongoing scale‑up
Pipeline ExpansionExploring additions; VRK1 program DAY301 licensed; $55M upfront; IND cleared; first dosing planned Accelerating pipeline build
Corporate FinanceCash runway into 2026 $108M PRV sale; $175M private placement Strengthened balance sheet

Management Commentary

  • “We had an outstanding quarter across all facets of our business. Demand for OJEMDA led to strong early launch performance...” — CEO Jeremy Bender .
  • Strategy emphasizes “Building a Sustainable Company with Durable Growth” backed by $361.9M cash and execution across OJEMDA, DAY301, and FIREFLY‑2 .
  • On DAY301: “We believe the linker‑payload technology embodied in DAY301 will overcome the limitations of earlier PTK7‑targeted ADCs...” — Dr. Samuel Blackman .

Q&A Highlights

  • The full Q2 2024 earnings call transcript was not available via our document tools; the company hosted a call and webcast on July 30, 2024, but only press releases and presentations were accessible for this analysis .
  • Without transcript access, detailed Q&A themes, guidance clarifications, and tone shifts versus prior quarters cannot be reliably extracted.

Estimates Context

  • S&P Global consensus EPS and revenue estimates for Q2 2024 were unavailable due to an API limit at time of request, so we cannot formally mark beats/misses against Street numbers. Values from S&P Global could not be retrieved; if provided, comparisons would anchor to S&P Global consensus .
  • Implication: Early OJEMDA revenue ($8.19M) and ex‑U.S. licensing economics may bias future Street revisions upward on revenues and cash runway; however, R&D elevated by the DAY301 upfront shapes near‑term opex trajectories .

Key Takeaways for Investors

  • Commercial inflection confirmed: First OJEMDA revenue with demand‑dominant mix and strong payer approvals indicates a solid launch trajectory; watch breadth/depth of prescribers into Q3/Q4 .
  • Balance sheet strength: $361.9M cash, $108.0M PRV proceeds, and $175.0M private placement fund commercialization and pipeline, reducing financing overhangs near‑term .
  • Strategic leverage ex‑U.S.: Ipsen deal monetizes global rights with upfront, milestones, and tiered royalties; track Ipsen timelines and ex‑U.S. launch geographies for incremental revenue streams .
  • Pipeline pivot to ADC: Closure of pimasertib concentrates R&D on DAY301 with near‑term clinical entry; day‑one performance in Phase 1/2a and target tumor selection are key de‑risking events .
  • Watch operating profile: Q2 R&D was elevated by a $55M upfront; expect opex normalization excluding one‑time BD costs, but sustained SG&A as commercialization scales .
  • Near‑term trading catalysts: Additional FIREFLY‑1 analyses, payer policy solidification, prescriber expansion, and any early ex‑U.S. updates could drive sentiment; absence of formal guidance increases sensitivity to datapoints .
  • Risk balance: Accelerated approval implies continued evidence requirements; FIREFLY‑2 outcomes and safety/tolerability in real‑world use remain decisive for longer‑term thesis .

Sources

  • Q2 2024 press release and 8‑K exhibits (financials, launch KPIs, Ipsen/DAY301 updates) .
  • Q2 2024 8‑K press release exhibits (Ex‑99.1 financials and KPIs; slides Ex‑99.2/99.3) .
  • Q1 2024 press release and 8‑K exhibits (first prescriptions, Q1 financials) .
  • Q4/FY 2023 press release and 8‑K exhibits (cash runway, PDUFA) .
  • Private placement press release .
  • DAY301 licensing press release .

S&P Global consensus estimates were unavailable due to API limits; therefore, beats/misses versus Street cannot be provided for Q2 2024.