NRX Pharmaceuticals, Inc. (NRXP)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 showed continued operating discipline: loss from operations improved to $2.4M versus $4.4M in Q4 2023, driven by lower R&D and a settlement gain, partially offset by higher G&A tied to HOPE clinic acquisition work . EPS was a miss versus consensus: -$0.77 actual vs -$0.37 consensus (3 estimates) as the company remains pre-revenue and invested in platform buildout for HOPE and regulatory progress for NRX-100/101 [GetEstimates]*.
• Regulatory catalysts advanced: Module 3 (CMC) for NRX-100 (IV ketamine) was filed; the company now anticipates PDUFA dates for NRX-100 and NRX-101 prior to December 31, 2025. An ANDA for preservative-free ketamine across current indications is planned for Q2 2025 .
• Strategic momentum: non-binding terms accepted with a commercial pharma partner to license and distribute NRX-100 (over $300M in milestones plus tiered double-digit royalties) and a term sheet from a strategic TMS device maker to help fund HOPE clinic expansion .
• Financing and runway: cash was $1.4M at year-end; two January 2025 financings totaled ~$8.5M; management expects available cash to support operations through at least end of 2025 and forecasts profitability on a run-rate basis by year-end 2025 .
• Stock-relevant narrative: a potential NRX-100 out-licensing, near-term FDA filings, and visible HOPE clinic roll-up progress are key catalysts; removal of benzethonium chloride preservative and unique packaging create differentiation for ketamine products .

What Went Well and What Went Wrong

What Went Well

• Filed NRX-100 NDA Module 3; ANDA planned Q2 2025, with anticipated PDUFA dates for NRX-100 and NRX-101 by year-end 2025 . “We launched the filing of a New Drug Application for NRX-100... a major milestone for NRx” .
• Strategic interest: accepted non-binding terms to license NRX-100 with >$300M milestones plus tiered double-digit royalties; engaged BTIG for clinic acquisition and capital formation; term sheet from a publicly traded TMS manufacturer to support HOPE .
• Operating efficiency: Q4 loss from operations improved ~45% YoY to $2.4M, with R&D down to $1.0M, reflecting Phase 2b/3 NRX-101 study completion . “Substantially reduced operating costs compared to prior year” .

What Went Wrong

• EPS miss vs consensus, reflecting pre-revenue status and elevated G&A tied to transaction work for HOPE clinics; Diluted EPS actual -$0.77 vs consensus -$0.37 (3 estimates) [GetEstimates]*. Q4 G&A increased ~$0.7M YoY to $2.6M due to consulting for clinic acquisitions .
• Liquidity remains tight: cash was $1.4M at Dec 31, 2024 (though supplemented by ~$8.5M raised in Jan 2025); reliance on debt and pending strategic funding highlights financing risk if timelines slip .
• Execution risk in clinic roll-up: multiple LOIs and negotiations in progress; regulatory and state-level complexities to close healthcare facility acquisitions; management highlights extensive legal diligence and financing stack coordination .

Financial Results

Headline EPS and Revenue vs Estimates (Q4 2024)

Note: EPS consensus mean and counts, and actuals from S&P Global; revenue consensus mean indicates pre-revenue expectations. Values retrieved from S&P Global.*

Result: EPS was a significant miss versus consensus (bold indicates miss): -$0.77 vs -$0.37 [GetEstimates]*.

Operating Metrics (Quarterly trend)

Footnotes:

• Q3 “operating net loss” is as disclosed; Q4 provides “loss from operations” specifically .
• Jan 2025 financing added ~$8.5M gross proceeds post-Q4 .

Annual comparison (context)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We launched the filing of a New Drug Application for NRX-100 for the treatment of Suicidal Depression: a major milestone for NRx.” — Jonathan Javitt, Chairman & CEO .
• “We have proven manufacturing capacity to supply more than 1 million doses per month, should we gain FDA approval.” .
• “We believe the strategic term sheet... to acquire this product for more than $300 million in total milestones and a double-digit royalty provides further validation.” .
• “We are filing a citizens’ petition with the FDA to remove ketamine preparations with benzethonium chloride from the market until it can be shown safe for repeated use.” .
• “Management continues to forecast, although no assurances can be given, profitability on a forward-looking run-rate basis by year end 2025.” .

Q&A Highlights

• Preservative-free ketamine rationale: single-use vials remove the need for benzethonium chloride; company demonstrated 2-year room-temperature stability without preservative .
• HOPE acquisition strategy: Florida focus; “chunky” multi-clinic transactions; funding stack combining bank loans (up to ~50% LTV), equity from clinic sellers (HOPE shares), and mezzanine capital; legal and regulatory diligence emphasized .
• NRX-100 commercial deal: non-binding interest could broaden; partner with existing sales force preferred; inflection point for investors if finalized .
• ANDA and NDA simultaneous paths: shared manufacturing package; NDA to add suicidality indications; ANDA to offer preservative-free ketamine for existing indications .
• International strategy: potential European filing leveraging French government-funded trial data (Fondation FondaMental); relationships may expand interest in APAC .

Estimates Context

• Q4 2024 EPS: consensus -$0.37 vs actual -$0.77 (3 estimates) — a miss likely driven by pre-revenue status and higher G&A tied to clinic acquisition activities in Q4 [GetEstimates]* .
• Q4 2024 Revenue: consensus $0.00; company did not disclose product revenue, consistent with pre-revenue biotech profile [GetEstimates]* .
• Implications: near-term EPS estimates should reflect ongoing corporate build (HOPE roll-up, regulatory filings) and limited revenue recognition until clinic acquisitions close and NRX-100/101 approach commercialization.

Values retrieved from S&P Global.*

Key Takeaways for Investors

• Regulatory catalysts stack in 2025: both NRX-100 and NRX-101 targeting PDUFA dates before YE 2025, with an ANDA in Q2 2025 that could unlock broader preservative-free ketamine market exposure .
• Potential NRX-100 out-licensing (>$300M milestones + tiered double-digit royalties) provides non-dilutive validation and funding optionality; monitor for deal finalization in coming quarters .
• HOPE roll-up is central to near-term revenue: expect “chunky” acquisitions, Florida concentration, ~30% clinic margins; execution on financing stack and regulatory diligence will determine timeline and scale .
• Differentiation: preservative-free, diversion-resistant ketamine vials and citizen petition targeting benzethonium chloride should enhance patient safety positioning and potential payer acceptance post-approval .
• Operating discipline continues: R&D decline post NRX-101 Phase 2b/3 completion; G&A increases tied to transactions; cash runway extended with Jan financings and management’s year-end 2025 visibility .
• Trading lens: stock likely sensitive to (i) NDA/ANDA filing milestones, (ii) licensing deal closure, (iii) HOPE clinic acquisition closings, and (iv) FDA feedback on citizens’ petition and fast-track/priority review steps .
• Risk factors: financing dependency until revenue emerges, acquisition integration risk, regulatory review uncertainties, and timing slippage could affect estimates and narrative momentum .

Values retrieved from S&P Global.