Longeveron Inc. (LGVN)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 revenue of $0.316M missed Wall Street consensus of $0.412M; EPS of -$0.33 beat consensus of -$0.353. The miss was driven by weaker Bahamas registry demand and reduced contract manufacturing activity, while EPS benefited from other income and lower per-share loss versus expectations * *.
• Completed full enrollment (40 patients) in pivotal Phase 2b ELPIS II (HLHS); top-line results expected Q3 2026 and BLA submission targeted for late 2026, assuming positive data—management emphasized organizational and CMC readiness via a CDMO strategy to accelerate commercialization .
• Cash and equivalents were $10.3M at quarter-end; following an August financing (~$5M + up to $12.5M in warrant proceeds), runway extends into Q1 2026; OpEx expected to rise through 2H25 and 2026 to support BLA-readiness (CMC/manufacturing) .
• Pipeline expanded: FDA approved IND for Pediatric Dilated Cardiomyopathy (DCM) to proceed directly to a pivotal Phase 2 trial (initiation targeted 1H 2026, financing-dependent); AD program advanced with positive FDA Type B meeting supporting a single pivotal Phase 2/3 design .

What Went Well and What Went Wrong

What Went Well

• Full enrollment of pivotal ELPIS II (HLHS) achieved; management reiterated late-2026 BLA timing, focusing on readiness to potentially shorten submission timeline: “We are focused on organizational readiness for a potential BLA filing for HLHS in late 2026” .
• Regulatory momentum: FDA Type B alignment for AD pivotal Phase 2/3; FDA approved IND to move directly into a pivotal Phase 2 for pediatric DCM—rare accelerated pathway .
• CMC strategy de-risked via CDMO decision: “Pursue commercial manufacturing through a third party CDMO… leverage scale, experience, and compliance infrastructure” to mitigate timeline, cost, and facility readiness risk .

What Went Wrong

• Revenue contracted year over year and quarter over quarter, driven by decreased participant demand in the Bahamas registry and lighter contract manufacturing activity; total Q2 revenue fell to $0.316M (vs $0.468M YoY, $0.381M QoQ) .
• Gross margin compressed sharply (to 46.2% from ~73% YoY/QoQ), reflecting unfavorable mix and lower volumes; gross profit was $0.146M vs $0.344M YoY and $0.275M QoQ .
• OpEx stepped up (G&A $2.589M; R&D $2.954M) with continued investment in personnel/equity comp and BLA-enabling CMC/manufacturing readiness, expanding net loss from operations (-$5.397M) .

Financial Results

P&L vs Prior Year and Prior Quarter

Note: Gross margin calculated from reported revenue and gross profit; citations reference source figures.

Actual vs Wall Street Consensus (S&P Global)

Values marked with * retrieved from S&P Global.

• Result: Revenue miss; EPS beat versus consensus *.

Revenue Breakdown

KPIs and Operating Metrics

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• CEO: “We are focused on organizational readiness for a potential BLA filing for HLHS in late 2026… to potentially shorten the timeline to BLA submission and potential commercialization.”
• CTO: “We’ve made a deliberate decision to pursue commercial manufacturing through a third party CDMO… more cost effective and de-risks facility readiness.”
• CFO: “We currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2026.”
• CMO on ELPIS I: “100% transplant-free survival up to five years… compared to approximately 20% mortality rate observed from historical control data.”

Q&A Highlights

• Market sizing and pricing dynamics: HLHS prevalence ~1,000; pediatric DCM prevalence ~2,000–3,000; DCM incidence ~600/yr; pricing strategies expected to be comparable with different administration paradigms (HLHS one-time intramyocardial injection vs DCM chronic IV infusion) .
• Regulatory readthrough: Positive HLHS data would support DCM regulatory review, but FDA will still require endpoints met in DCM; FDA agreed the DCM Phase 2 could be sufficient for approval upon positive results .
• Trial economics: Preliminary DCM Phase 2 cost estimated at $15–$20M total over 4–5 years; pursuing non-dilutive funding to offset costs .
• Manufacturing choice: CDMO selected to accelerate BLA timing, reduce capital intensity, and leverage proven regulatory track record .
• PRV program: Management cautiously optimistic about renewal; alternative pathways (Fast Track) can still support rolling submissions .

Estimates Context

• Q2 2025 actual revenue $0.316M vs consensus $0.412M* (miss); Q2 2025 EPS -$0.33 vs consensus -$0.353* (beat). Four estimates contributed to both metrics* *.
• Target price consensus remained at $6.86*; consensus recommendation text unavailable*. Near-term estimate revisions likely to reflect a lower revenue base and higher OpEx trajectory, partially offset by regulatory catalysts and financing runway extension*.

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

• HLHS pivotal dataset in Q3 2026 and a late-2026 BLA target are the core valuation catalysts; the CDMO strategy is an operational de-risker for CMC readiness .
• Revenue softness and margin compression reflect registry demand variability and contract manufacturing mix; near-term P&L will be dominated by R&D/G&A and CMC build, not topline growth .
• Liquidity improved post-August offering; runway into Q1 2026 provides time to reach key regulatory milestones; watch warrant exercises for incremental cash .
• Pediatric DCM IND approval to a pivotal Phase 2 is a meaningful pipeline broadening; composite endpoints focused on mortality, transplant, and HF hospitalization may resonate with regulators .
• Alzheimer’s program maintains a single-pivotal pathway with RMAT/Fast Track; partnering remains the likely funding route—an AD partnership would be a material upside catalyst .
• Trading setup: Expect sensitivity to regulatory updates (FDA interactions, PRV program developments), financing actions, and any CMC/CDMO milestones; near-term prints may be more driven by narrative than revenue beats.
• Medium-term thesis: Rare pediatric focus (HLHS/DCM) with accelerated regulatory paths, de-risked manufacturing, and a balanced BD strategy in AD can drive value ahead of the pivotal HLHS readout—execution on financing and CMC remains critical .