CHIMERIX INC (CMRX)·Q1 2024 Earnings Summary

Executive Summary

• Q1 2024 delivered a pre‑revenue quarter with disciplined spend: net loss of $21.9M ($0.25 per share), R&D $18.8M, G&A $5.5M; capital available to fund operations was $188.2M and no debt .
• ONC201 Phase 3 ACTION study continued steady-state accrual across 135+ sites in 13 countries; the company reiterated interim OS data in 2025 and final OS in 2026 .
• New regulatory catalyst: Australia’s TGA agreed ONC201 meets criteria to advance to Provisional Determination; Chimerix targets a filing around year-end 2024 with potential commercial availability in 2026 .
• ONC206 progressed in Phase 1 dose escalation with no dose-limiting toxicities to date; preliminary safety and PK data expected mid‑2024/summer .
• Cash runway guided “into 4Q 2026,” supporting pivotal ACTION milestones and near-term ONC206 readouts; management highlighted capital efficiency (rolling 4Q burn ~$58M) .

What Went Well and What Went Wrong

What Went Well

• ACTION enrollment and site activation remain on track for interim OS in 2025; management cited “steady state accrual” and strong global demand including patient travel to sites .
• Regulatory momentum: TGA presubmission concluded ONC201’s Phase 2 dataset likely meets criteria for provisional approval; ONC201 can advance to Provisional Determination .
• ONC206 safety profile intact with intensified dosing; no dose-limiting toxicities observed and preliminary safety/PK readout expected this summer .
  • Quote: “We remain intensely focused on completion of the ACTION study… and will continue to be active and collaborative with regulators to bring dordaviprone to patients in need as soon as possible.” – CEO Mike Andriole .

What Went Wrong

• Revenue declined to zero (vs $0.283M prior-year), reflecting absence of TEMBEXA-related revenue streams; net loss widened sequentially vs Q4 2023 though improved vs Q3 2023 .
• Near-term catalysts remain largely non-revenue: core stock drivers (interim OS, TGA path) are multi-quarter, limiting near-term fundamental inflection .
• Enrollment/event-rate variability still a swing factor; management noted levers needed for an “early 2025” interim (accelerated enrollment, event rates, expanded markets) .

Financial Results

P&L Snapshot (Quarterly)

Balance Sheet Metrics (Quarter-end)

Program KPIs

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• Strategic priority: “The success of the ACTION study… is central to our strategy as a positive outcome likely represents approval of the first medicine to treat this specific disease.” – CEO Mike Andriole .
• Regulatory path: “The TGA agreed that dordaviprone meets the criteria to advance… preliminary data is likely to provide a ‘major therapeutic advance’… ACTION could provide pivotal confirmatory data.” – Press release .
• Capital discipline: “Our rolling 4 quarter burn rate of $58 million… benchmarks us among the most capital‑efficient Phase III company in our peer group.” – CFO Michelle LaSpaluto .

Q&A Highlights

• ACTION interim timing levers: To achieve “early 2025”, management flagged the need for accelerated enrollment/productivity and/or earlier/more frequent event rates; expanded markets could help .
• TGA mechanics: Provisional Determination review ~20 working days; Provisional Registration review ~255 working days; submission not contingent on Phase 3 data, but trial must be well underway .
• ONC206 data cadence: Adult/pediatric trials proceeding in parallel; safety/PK summary expected mid‑2024 with representation from both trials (~75 patients aggregate, skew pediatric) .
• Mutation/SoC differences: H3 K27M incidence appears uniform globally; ex‑US temozolomide use higher, especially adults; radiation remains global standard .
• Overlap with BRAF: H3 K27M does not typically co‑occur with actionable BRAF alterations; ONC201 frontline setting distinct from tovorafenib’s recurrent approval .

Estimates Context

• We attempted to retrieve Wall Street consensus estimates (EPS, revenue, EBITDA, target price) via S&P Global; data were unavailable due to missing CIQ mapping for CMRX (tool error: SpgiEstimatesError) [GetEstimates attempt].
• As a result, consensus comparisons to estimates are unavailable; investors should note that near‑term fundamental drivers are non-revenue trial/regulatory milestones rather than P&L beats/misses .

Key Takeaways for Investors

• Regulatory optionality adds a new de‑risking path: Australia’s TGA provisional route could enable earlier ONC201 access outside the U.S., with potential availability in 2026, while ACTION proceeds toward interim OS in 2025 .
• Near-term catalyst stack: ONC206 preliminary safety/PK this summer; continued ACTION site expansion/productivity; potential updates on TGA process cadence—each can drive sentiment and stock reaction .
• Execution on enrollment matters: Management highlighted levers for earlier 2025 interim; watch for added high‑density ex‑US sites and event-rate commentary in future updates .
• Balance sheet supports runway through pivotal readouts without debt: $188.2M capital and runway into 4Q 2026 underpin the program while preserving optionality on partnerships .
• Risk framing: Pre‑revenue biotech with binary‑ish Phase 3 outcomes; trial event-rate variability and regulatory timelines are key; no DLTs seen for ONC206 bolsters multi‑asset optionality .
• Commercial planning: Lean model envisioned; high unaided awareness in neuro‑oncology and ultra‑rare setting could support efficient launch planning post‑pivotal data .
• Monitoring items: ACTION enrollment momentum, TGA application progression, ONC206 biomarker-led indication selection, and cash burn trajectory relative to 2026 runway .

Appendix: Additional Data

Program/Operational Details

• ACTION design: 450 patients, randomized to weekly or twice‑weekly ONC201 or placebo; primary endpoint OS; PFS alpha-allocated; interim OS in 2025, final OS in 2026 .
• ONC201 Phase 2 efficacy: ORR 20–30% by RANO criteria; median DOR 11.2 months; OS rates 57% at 12 months, 35% at 24 months; robust safety profile .
• TEMBEXA economics: $238M upfront (2022), up to $124M BARDA milestones, 20% U.S. royalty above volume threshold, 15% international royalty, $12.5M dev milestones .