Executive Summary

Q4 2024 reflected steady operating execution ahead of regulatory and M&A catalysts: total revenue of $0.06M, net loss of $23.0M (-$0.25/share) vs Q4 2023 net loss of $18.2M (-$0.20/share) and Q3 2024 net loss of $22.9M (-$0.26/share). Year-over-year OpEx rose on R&D and pre-launch G&A, consistent with strategy. No Q4 earnings call was held due to the pending Jazz acquisition .
Regulatory path firmed: FDA accepted the NDA for dordaviprone with a PDUFA action date of August 18, 2025; in March the company paused U.S. enrollment in the Phase 3 ACTION study during the NDA review to mitigate confounding, while expanded access remains available for recurrent disease .
Balance sheet remained solid for a clinical-stage company: capital available to fund operations was $140.1M at 12/31/24; no outstanding debt; 92.2M shares outstanding at year-end .
Strategic catalyst: Jazz Pharmaceuticals agreed to acquire Chimerix for $8.55/share cash (~$935M EV); tender offer expected to close in Q2 2025, subject to customary conditions. This deal likely drives near-term stock behavior pending close and regulatory progress .
Estimates context: S&P Global consensus EPS and revenue estimates for Q4 2024 were unavailable through our feed (missing mapping); management provided no financial guidance. Comparison to Street estimates is therefore not determinable in this period .

What Went Well and What Went Wrong

What Went Well

FDA acceptance of dordaviprone NDA with a defined PDUFA date: “The recent FDA acceptance of the dordaviprone NDA marks an important milestone… Our mission… is greatly enhanced by the pending acquisition of Chimerix by Jazz.” – CEO Mike Andriole .
Strong capital position into key catalysts: $140.1M capital available at 12/31/24; no debt outstanding, supporting launch prep and ACTION execution .
Strategic clarity and potential commercialization partner: announced definitive agreement for Jazz to acquire Chimerix, positioning resources and infrastructure to accelerate availability if approved .

What Went Wrong

Operating loss widened YoY on higher R&D and launch readiness G&A: Q4 R&D $17.7M vs $15.6M YoY; G&A $7.0M vs $5.2M YoY; net loss -$23.0M vs -$18.2M YoY .
Interest income declined vs prior year, reflecting lower investment income as rates/portfolio mix changed (interest and other $1.6M vs $2.6M YoY) .
No Q4 earnings call; limited near-term visibility into OpEx cadence and commercialization spend phasing given pending transaction and regulatory timeline .

Financial Results

Headline P&L vs prior periods and estimates

Metric	Q4 2023	Q3 2024	Q4 2024	Vs Est.
Revenue ($USD Millions)	$0.00	$0.03	$0.06	N/A (consensus unavailable)
Net Loss ($USD Millions)	$(18.16)	$(22.88)	$(22.95)	N/A
Diluted EPS ($)	$(0.20)	$(0.26)	$(0.25)	N/A
R&D Expense ($USD Millions)	$15.64	$19.65	$17.66	N/A
G&A Expense ($USD Millions)	$5.17	$5.17	$6.95	N/A
Interest & Other, net ($USD Millions)	$2.65	$1.91	$1.60	N/A

Notes: Management did not provide financial guidance; Street estimates were unavailable via S&P Global feed for CMRX this quarter.

Operating metrics (biotech KPIs)

KPI	Q4 2023	Q3 2024	Q4 2024
Weighted Avg Shares (Basic & Diluted)	88.91M	89.70M	90.26M
Capital Available to Fund Operations	N/A	$152.4M (9/30/24)	$140.1M (12/31/24)
Debt Outstanding	N/A	None	None
Shares Outstanding (End of Period)	88.93M (12/31/23)	89.94M (9/30/24)	~92.2M (12/31/24)

Balance sheet highlights (select line items)

Metric	12/31/2023	9/30/2024	12/31/2024
Cash & Cash Equivalents ($M)	$27.66	$23.65	$31.05
Short-term Investments ($M)	$155.17	$112.59	$100.59
Long-term Investments ($M)	$21.66	$16.20	$8.48
Total Assets ($M)	$212.77	$158.67	$146.01
Total Stockholders’ Equity ($M)	$193.03	$135.78	$121.68

Segment breakdown: Not applicable (no reportable revenue segments) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Dordaviprone NDA status	U.S.	File NDA; Priority Review requested; potential Q3 2025 PDUFA (12/30/24)	NDA accepted; PDUFA August 18, 2025 (3/21/25 release)	Updated to specific action date
ACTION Phase 3 interim OS	Global	First interim OS expected Q3 2025 (Q2/Q3 2024)	Maintained timing expectation (no Q4 call; reiterated trajectory in prior updates)	Maintained
U.S. ACTION enrollment	U.S.	Ongoing enrollment (Q3 2024)	Pause U.S. enrollment during NDA review to mitigate confounding; expanded access available on progression (3/3/25)	New (process change)
Earnings communication	Q4 2024	Routine quarterly call (historically)	No Q4 2024 conference call due to pending Jazz transaction	New

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 & Q3 2024)	Current Period (Q4 2024)	Trend
Regulatory path (U.S.)	Pursued Priority Review; planning for NDA dossier; ACTION interim OS in Q3’25	NDA accepted; PDUFA Aug 18, 2025	Firmed timeline
Australia (TGA)	Provisional Registration pathway; ODD granted; aligning to file; potential availability as early as 2025/26	No new Q4 call; prior strategy unchanged	Steady
ACTION safety/IDMC	IDMC recommended continuation as-is after safety review	U.S. enrollment paused during NDA review (Mar) to avoid confounding	Operational adjustment in U.S.
ONC206 program	Escalation into therapeutic range; safety/PK favorable; response assessment H1’25	No new Q4 call updates	Await H1’25 readouts
Commercial readiness	“Gated” pre-launch spend; payer and KOL engagement; runway into 4Q26	G&A up mainly on launch preparations	Spending ramps prudently
TEMBEXA economics	BARDA partial exercise; ~$2.7M due to CMRX from $67.4M option (timing upon cash receipt)	No new Q4 call updates	Non-core upside optionality
M&A / Strategic	N/A	Jazz to acquire CMRX for $8.55 cash/share	Transformative deal announced

Management Commentary

“The recent FDA acceptance of the dordaviprone NDA marks an important milestone… Our mission… is greatly enhanced by the pending acquisition of Chimerix by Jazz.” – Mike Andriole, CEO (Q4 release) .
“We ended the third quarter with just over $152 million in cash and cash equivalents… We are committed to sensible cash management… runway extending into the fourth quarter of 2026.” – Michelle LaSpaluto, CFO (Q3 call) .
“The Phase III ACTION study… first interim data readout is potentially less than a year away… IDMC… recommended the ACTION study continue as is.” – Mike Andriole (Q3 call) .
“ONC206… dosing within an expected therapeutic range… exposures… not… associated with dose limiting toxicities… complete enrollment… by the end of the year.” – Michael Andriole/Joshua Allen (Q2 call) .

Q&A Highlights

Australia regulatory/commercial path: Management aims for a lean model with potential distribution partners; TGA path based on Phase 2 response data; P3 ACTION remains first opportunity for broader registrations .
TEMBEXA economics: BARDA partial option exercise of $67.4M yields ~$2.7M due to Chimerix as milestone (recognized on cash receipt); potential future royalties from ex-U.S. indications like monkeypox are long-dated and uncertain .
ACTION enrollment/events: Enrollment geographically balanced; screen failure rates consistent with expectations; blinded event rate updates expected in subsequent quarters as data accrue .
ONC206 efficacy timing: Objective response assessment targeted for H1 2025 in higher dose cohorts; safety/PK readouts to follow cohort completion .

Note: No Q4 2024 earnings call was held due to the pending Jazz acquisition . Q&A themes above reflect Q2/Q3 2024 calls that frame the current narrative.

Estimates Context

S&P Global consensus EPS and revenue estimates for Q4 2024 could not be retrieved due to a missing mapping for CMRX in our feed; management provided no financial guidance. As a result, beat/miss versus Street is not determinable for this quarter .
Given limited/no product revenue and R&D-driven losses, estimate dispersion is typically wide for development-stage biotech; upcoming catalysts (PDUFA, ACTION interim OS) are more likely to drive estimate revisions than Q4 financials .

Key Takeaways for Investors

Near-term stock driver is the announced acquisition by Jazz at $8.55/share cash; focus shifts to tender progress/timing and standard closing risks in Q2 2025 .
Regulatory catalyst path is defined: dordaviprone PDUFA on Aug 18, 2025; U.S. ACTION enrollment pause should reduce potential confounding during the NDA review, with expanded access maintaining patient availability on progression .
Operating spend uptick tied to launch readiness (higher G&A) while maintaining robust capital ($140.1M at year-end) and no debt, supporting execution through key milestones .
ONC206 remains a medium-term optionality asset with H1 2025 initial response assessment expected; positive safety/PK underpins potential future development decisions .
For trading: the M&A spread versus $8.55 likely reflects deal/regulatory/event risks; key watch items are tender uptake, regulatory interactions, and any interim safety/operational updates on ACTION .
For the medium-term thesis: if the deal closes, upside participation transitions to Jazz; if not, PDUFA and ACTION interim OS remain the principal value inflection points under a standalone scenario .

Sources:

Q4 2024 8-K and press release (financials, capital, no call, PDUFA) .
Q3 2024 8-K and call transcript (operational updates, cash runway) .
Q2 2024 8-K and call transcript (ONC206 safety/PK; Australia pathway) .
Dec 30, 2024 8-K (NDA submission; Priority Review request; Nasdaq compliance) .
Mar 3, 2025 8-K (pause U.S. enrollment during NDA review) .
Mar 5, 2025 8-K (Jazz acquisition terms) .

CHIMERIX INC (CMRX)·Q4 2024 Earnings Summary