CHIMERIX INC (CMRX)·Q3 2024 Earnings Summary

Executive Summary

• Q3 2024 delivered disciplined execution: ACTION Phase 3 passed the IDMC safety review with a recommendation to continue the study “as-is,” including the higher-intensity twice-weekly dose; the company remains on-track for the first interim OS readout in Q3 2025 .
• Australia pathway accelerated: alignment to submit the dordaviprone NDA for Provisional Approval “in the coming months,” with potential commercial availability as soon as year-end 2025 (earlier than the Q2 expectation of possible 2026) .
• Financials: net loss of $22.9M ($0.26 per share) vs $24.0M ($0.27) YoY as R&D rose on ACTION spend and G&A declined due to prior-year one-time non-cash equity expense; cash and investments totaled $152.4M with no debt .
• ONC206 progressing: dose-escalation nearing completion, exposures in the modeled therapeutic range, and objective response assessments to begin in H1 2025; no dose-limiting toxicities observed to date across adult and pediatric cohorts .
• Near-term catalysts: submission of Australia provisional NDA, SNO/EANO presence elevating awareness, ONC206 dose-escalation completion by year-end, and mid-2025 first potential response assessments; these set the narrative ahead of ACTION interim OS data in Q3 2025 .

What Went Well and What Went Wrong

What Went Well

• ACTION Phase 3 passed the preplanned IDMC safety review with a recommendation to continue the study without changes, supporting the tolerability of both weekly and twice-weekly dosing arms and de-risking execution heading into the interim analysis .
• Regulatory momentum: orphan designation from the TGA and alignment to file for Provisional Approval in Australia in the coming months, with potential availability by year-end 2025, indicating a viable accelerated path outside the U.S. .
• ONC206 safety/PK: dose intensification achieved dose-proportionate exposure with no dose-limiting toxicities; majority of TRAEs mild-to-moderate, consistent across adults/pediatrics—supporting confidence in reaching biologically active exposures .

Quote: “The IDMC’s preplanned safety review…recommended continuing study conduct as-is, including at the more intense twice per week dose.” — CEO Mike Andriole .
Quote: “We now have alignment to file a New Drug Application (NDA) for Provisional Approval in Australia…expected to occur in the coming months.” — CEO Mike Andriole .

What Went Wrong

• Ongoing operating losses: Q3 net loss of $22.9M with R&D elevated ($19.6M) due to ACTION execution; minimal revenue ($26k) keeps margins not meaningful and heightens dependence on cash/runway .
• Consensus context unavailable: S&P Global consensus mapping failed for CMRX, preventing beat/miss benchmarking versus Street for Q3 (limits near-term estimate-driven catalysts in public markets). Values retrieved from S&P Global were unavailable due to mapping; see Estimates Context.
• Royalty/milestones timing uncertainty: while BARDA partially exercised $67.4M of TEMBEXA procurement options at Emergent, CMRX expects ~$2.7M tied to this but will only recognize after cash receipt, adding timing uncertainty to non-dilutive inflows .

Financial Results

Income Statement Snapshot (Quarterly)

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Notes:

• Margins not presented: revenue immaterial and biopharma pre-commercial stage makes Net Income Margin % not meaningful .

Balance Sheet / Liquidity KPIs

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Guidance Changes

No formal financial guidance (revenue, margins, OpEx ranges, OI&E, tax rate, dividends) was provided in Q3 2024 materials .

Earnings Call Themes & Trends

Management Commentary

• Prepared remarks emphasized ACTION momentum and safety de-risking: “Passing this IDMC safety review with no change to study conduct to any arm is a meaningful milestone and underscores the well-documented safety profile of dordaviprone…” — CEO Mike Andriole .
• Regulatory strategy: “We have alignment to file a New Drug Application (NDA) for Provisional Approval in Australia which we expect to occur in the coming months.” — CEO Mike Andriole .
• Commercial preparation: “Our med affairs team is up and running… early commercialization efforts are focused around payer engagement, forecast confirmation… we are going to be conservative and gated as we get more data.” — President/COO Thomas Riga .
• Liquidity/Runway: “We ended the third quarter with just over $152 million in cash and cash equivalents… Currently, we have a cash runway extending into the fourth quarter of 2026.” — CFO Michelle LaSpaluto .
• ONC206: “Completion of enrollment in the remaining dose escalation cohorts is expected to occur in 2024… assess any objective responses in the first half of 2025…” — Company press release .

Q&A Highlights

• Australia Provisional Approval: Management confirmed the Australia NDA backbone will aid other geographies and commercial readiness; approach is gated with payer engagement and infrastructure build to manage SG&A .
• TEMBEXA economics: BARDA partial option exercise (~$67.4M at Emergent) entitles CMRX to approximately $2.7M, to be recorded upon cash receipt; monkeypox trial could open future international royalty opportunities, but it’s early .
• Tone: Confident and disciplined, highlighting safety de-risking in ACTION, regulatory agility in Australia, and controlled commercialization spend ahead of data .

Estimates Context

• Wall Street consensus (S&P Global) for quarterly EPS, revenue, EBITDA, target price, and recommendation was unavailable due to a missing Capital IQ mapping for CMRX at the time of query. Values retrieved from S&P Global were unavailable; no estimate-based beat/miss benchmarking could be performed.
• Given pre-commercial status and minimal revenues, Street coverage may be limited; estimate revisions are likely to hinge on regulatory milestones (Australia NDA submission/provisional approval) and ACTION interim OS timing .

Financial Results vs Prior Periods and Year-Over-Year

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Observation: EPS and net loss improved YoY on lower G&A vs a one-time non-cash 2023 grant expense, while R&D increased due to ACTION execution; revenue remained immaterial .

Guidance Changes (Detail)

Key Takeaways for Investors

• ACTION safety de-risking and global enrollment support the probability of hitting Q3 2025 interim OS; narrative should focus on survival hazard ratios and potential paths to success outlined in the design .
• Australia could be a first commercialization foothold ahead of U.S./EU, with filing in coming months and possible availability by YE 2025—an earlier path than previously suggested .
• ONC206’s safety/PK profile at intensified dosing without DLTs and upcoming objective response assessments in H1 2025 creates a parallel optionality beyond dordaviprone .
• Balance sheet remains debt-free with $152.4M capital and runway into Q4 2026, enabling execution through key catalysts while maintaining gated SG&A .
• Non-dilutive inflows: Emergent/BARDA partial option (~$67.4M at Emergent) implies ~$2.7M to CMRX upon cash receipt; monkeypox study could open future royalties internationally over time .
• Near-term trading setup: watch for Australia NDA submission headlines, SNO meeting visibility, and ONC206 enrollment completion; stock likely to be catalyst-driven given lack of revenue and Street estimates .
• Medium-term thesis: ultra-orphan H3 K27M DMG with no approved therapies and a ~$750M global market opportunity if ACTION confirms survival benefit; IP through 2037 supports durability .

Additional Notes

• No non-GAAP metrics were disclosed; reported results are GAAP .
• Segment reporting not applicable; company is pre-commercial .
• Consensus estimates (S&P Global) unavailable due to mapping limitations; thus, no beat/miss assessment this quarter.