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Day One Biopharmaceuticals, Inc. (DAWN)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 marked DAWN’s transition to commercial stage: OJEMDA (tovorafenib) received FDA accelerated approval on April 23, 2024; first U.S. prescriptions have been written and launch activities are underway .
  • Operating expenses stepped up with commercialization: R&D $40.2M (vs $27.8M YoY), G&A $26.6M (vs $18.0M YoY), driving net loss to $62.4M and EPS of $(0.72) (vs $(0.59) YoY) .
  • Liquidity remains solid and was further enhanced post-quarter by sale of the FDA Priority Review Voucher for $108.0M in cash (with $8.1M payable to Viracta per license terms) .
  • Pricing set at $33,916 for a 28‑day supply; payer access and specialty pharmacy distribution (Biologics, Onco360) established alongside an “EveryDay Support” patient services program—key near-term revenue ramp catalysts .
  • No financial guidance or Street consensus comparison was available; we will update estimates context when S&P Global access is available (see Estimates Context) .

What Went Well and What Went Wrong

What Went Well

  • FDA accelerated approval for OJEMDA, the first and only therapy for relapsed/refractory pLGG with BRAF fusions/rearrangements or BRAF V600 mutation; CEO: “OJEMDA ushers in a new day… first and only FDA-approved medicine for children with BRAF fusions or rearrangements” .
  • Commercial launch underway with first prescriptions and robust patient support; CEO: “Our team is focused on executing our U.S. launch… and expanding our pipeline” .
  • Non‑dilutive capital from PRV sale strengthens balance sheet; CFO: “The sale of the PRV delivers true non-dilutive capital… further strengthens our balance sheet” .

What Went Wrong

  • Operating expenses increased meaningfully as commercialization began: R&D up to $40.2M and G&A to $26.6M, reflecting buildout and PRV‑related obligation payment, driving a larger net loss of $62.4M .
  • EPS declined year-over-year to $(0.72) from $(0.59) given higher operating spend during launch preparation .
  • No quantitative revenue reported for Q1 (pre-approval within quarter; approval occurred April 23), limiting ability to assess margin or revenue trends; press release highlighted first prescriptions but did not disclose product revenue .

Financial Results

P&L and EPS – Quarterly comparison

MetricQ3 2023Q4 2023Q1 2024
R&D Expense ($USD Millions)$33.2 $37.3 $40.2
G&A Expense ($USD Millions)$18.3 $22.2 $26.6
Net Loss ($USD Millions)$46.2 $54.5 $62.4
Net Loss per Share (EPS, $USD)$(0.54) n/a (not disclosed) $(0.72)

YoY for Q1:

  • R&D: $40.2M vs $27.8M (+$12.4M)
  • G&A: $26.6M vs $18.0M (+$8.6M)
  • EPS: $(0.72) vs $(0.59)

Balance sheet snapshot

MetricSep 30, 2023Dec 31, 2023Mar 31, 2024
Cash, Cash Equivalents & Short‑Term Investments ($USD Millions)$405.5 $366.3 $317.9
Total Assets ($USD Millions)$414.2 $376.0 $326.6
Total Liabilities ($USD Millions)$24.6 $29.5 $29.8
Total Stockholders’ Equity ($USD Millions)$389.6 $346.5 $296.8

Notes:

  • Post‑quarter PRV sale added $108.0M gross cash proceeds; $8.1M payable to Viracta per license obligations .

KPIs and commercialization metrics

KPIQ3 2023Q4 2023Q1 2024
FIREFLY‑2/LOGGIC sites activated~70 >80 >90
U.S. Account Managers hired—18 18 (continuing)
OJEMDA WAC price (28‑day supply, $USD)——$33,916
Launch markersNDA accepted, Priority Review Commercial team buildout FDA approval, first prescriptions, specialty pharmacy partners (Biologics, Onco360)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti‑year“Into 2026” (Dec 31, 2023) “Into 2026” (Mar 31, 2024) Maintained
FIRELIGHT‑1 RP2D & schedule2H 2024Expected 2H 2024 Expected 2H 2024 Maintained
Financial guidance (revenue/margins/OpEx)FY2024Not provided Not provided Maintained
OJEMDA U.S. availability2024Pending approval Approved Apr 23, 2024 Raised (milestone)
Pricing2024Not disclosed WAC $33,916 per 28-day supply Established

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023)Previous Mentions (Q4 2023)Current Period (Q1 2024)Trend
Regulatory/LegalNDA completed; Priority Review, PDUFA 4/30/24 PDUFA intact; continued preparation FDA accelerated approval on 4/23/24 Positive inflection (approval achieved)
Commercial launch readinessNational sales force hiring underway 18 Account Managers hired First prescriptions; specialty pharmacies; patient support program Launch execution ramping
Pricing & AccessNot discussedNot discussedWAC set at $33,916; payer coverage strategy via specialty pharmacy; EveryDay Support Visibility improved
R&D executionFIREFLY‑2 enrollment ongoing (~70 sites) FIREFLY‑2 >80 sites activated FIREFLY‑2 >90 sites; FIRELIGHT‑1 combo ongoing; RP2D in 2H 2024 Steady progress
Capital & liquidityCash $405.5M; runway into 2026 Cash $366.3M; runway into 2026 Cash $317.9M; PRV sold for $108M Strengthened via PRV sale
Pipeline expansionVRK1 preclinical program added (Aug 2023) —Post‑Q1: Exclusive license for DAY301 (PTK7 ADC), IND cleared Apr 2024 (announced Jun 18) Broadening (post‑Q1 disclosure)

Management Commentary

  • CEO Jeremy Bender on approval: “OJEMDA ushers in a new day for children living with relapsed or refractory pLGG… first and only FDA-approved medicine for children with BRAF fusions or rearrangements” .
  • CEO on Q1 strategy: “Our team is focused on executing our U.S. launch, on advancing our other programs, and on exploring opportunities to expand our pipeline” .
  • CFO Charles York II on PRV sale: “The sale of the PRV delivers true non-dilutive capital to Day One and further strengthens our balance sheet…” .
  • Pediatric neuro‑oncology perspective (UCSF): “We are excited to welcome a new targeted treatment option with once-weekly oral dosing designed specifically for these kids and their families” .

Q&A Highlights

We could not locate a Q1 2024 earnings call transcript in the available document set; the company announced approval and hosted a conference call, but a transcript is not present in this repository. As a result, Q&A themes and clarifications are not available for inclusion .

Estimates Context

  • Wall Street consensus via S&P Global (EPS and revenue) for Q1 2024 was not retrievable due to access limitations at the time of this analysis; we will update comparisons when data becomes available. No estimate comparisons are presented here [GetEstimates error].
  • Context: Approval on April 23 implies initial commercial revenue recognition begins post‑Q1; pricing set and first prescriptions reported, but no product revenue metrics disclosed for Q1 .

Key Takeaways for Investors

  • FDA approval and pricing clarity position OJEMDA for revenue initiation in Q2/Q3; early launch markers (first prescriptions, specialty pharmacy partners, patient support) are in place .
  • Operating expense step‑up reflects commercialization and PRV‑related obligations; monitor OpEx cadence vs launch productivity to assess cash burn trajectory .
  • Balance sheet fortified: $317.9M cash at Q1‑end plus $108.0M PRV proceeds (with $8.1M payable to Viracta), supporting runway into 2026—limits near‑term financing risk .
  • R&D momentum continues: FIREFLY‑2/LOGGIC enrollment expanding (>90 sites); FIRELIGHT‑1 combo with pimasertib targets RP2D in 2H 2024—key data flow to watch .
  • Commercial execution will drive stock narrative: payer coverage breadth, patient access speed, and conversion to weekly dosing should influence adoption velocity .
  • No formal financial guidance provided; track quarterly disclosures for net product revenue, gross-to-net dynamics, and potential inventory/channel metrics as the launch matures .
  • Post‑Q1 pipeline broadening (DAY301/PTK7 ADC) underscores multi‑asset strategy beyond pLGG; timing to first‑in‑human informs medium‑term optionality .