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Liquidia Corp (LQDA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was pre-commercial and investment-heavy ahead of anticipated YUTREPIA final FDA approval after Tyvaso DPI’s exclusivity expires on May 23, 2025, with management reiterating filing plans for final approval in late March and readiness to launch immediately upon approval .
  • Revenue of $2.917M in Q4 missed consensus of $4.598M by $1.681M (−36.6%); EPS of −$0.45 missed consensus of −$0.38, reflecting elevated OpEx to build commercial capabilities and ongoing legal spend *.
  • Balance sheet strengthened with up to $100M in additional financing from HCRx ($25M received at close; $50M at first commercial sale; $25M upon >$100M cumulative YUTREPIA net sales by June 30, 2026) .
  • Catalyst path is clear: request for final approval submitted “around March 24,” with management guiding to approval “on or near” May 23; ASCENT data preview showed 6MWD mean improvement of +26.4m at 8 weeks and dose titration to ≥15 breaths in most PH-ILD patients, supporting differentiation vs Tyvaso DPI .

What Went Well and What Went Wrong

What Went Well

  • Pipeline momentum: ASCENT PH-ILD study nearing enrollment completion; early cohort showed 6MWD +26.4m at week 8 and rapid dose escalation to levels beyond historical standards, supporting tolerability and efficacy narrative .
  • Financing flexibility: Amended HCRx agreement adds up to $100M; CFO highlighted pathway to profitability without additional equity if launch and targets are met .
  • Legal/regulatory clarity: No current legal barrier for FDA to issue final approval post-exclusivity; prior patent litigation resolved favorably, leaving only the ‘327 PH-ILD patent case set for June 2025 without a preliminary injunction .

What Went Wrong

  • Q4 revenue/EPS miss vs Street: Q4 revenue $2.917M vs $4.598M estimate and EPS −$0.45 vs −$0.38; misses driven by pump availability constraints on Treprostinil Injection and higher G&A for commercial buildout and litigation *.
  • Elevated OpEx: FY24 G&A rose 82% YoY to $81.6M, reflecting headcount/sales force expansion, litigation, and commercialization prep, pressuring losses (FY24 net loss −$130.4M) .
  • Treprostinil Injection headwinds: Ongoing limitations on subcutaneous pump availability continue to weigh on promotion agreement revenue .

Financial Results

Quarterly Results vs Prior Periods

MetricQ2 2024Q3 2024Q4 2024
Revenue ($)$3,659,000 $4,448,000 $2,917,000*
Diluted EPS ($)−0.37 −0.30 −0.45
Net Income ($)−$27,942,000 −$23,155,000 −$38,369,000*
Net Income Margin (%)−763.6%*−521.1%*−1,315.2%*
Total Operating Expenses ($)$30,856,000 $33,637,000 $39,024,000*
Cash & Equivalents (period-end) ($)$133,093,000 $204,368,000 $176,479,000

Notes: Asterisks denote values retrieved from S&P Global.

Actual vs Consensus (S&P Global) and Beat/Miss

MetricQ2 2024 ActualQ2 2024 EstimateBeat/MissQ3 2024 ActualQ3 2024 EstimateBeat/MissQ4 2024 ActualQ4 2024 EstimateBeat/Miss
Revenue ($)$3,659,000 $9,608,000*Miss$4,448,000 $4,188,500*Beat$2,917,000*$4,597,500*Miss
EPS ($)−0.37 −0.33*Miss−0.3878 [GetEstimates]*−0.374*Miss−0.45 −0.38*Miss

Notes: All consensus figures are from S&P Global; EPS actual for Q3 uses S&P Global’s reported actual; other actuals from company releases.

Full-Year Comparison

MetricFY 2023FY 2024YoY Change
Revenue ($)$17,488,000 $13,996,000 −$3,492,000 (−20.0%)
Cost of Revenue ($)$2,888,000 $5,879,000 +$2,991,000 (+103.6%)
R&D ($)$43,242,000 $47,842,000 +$4,600,000 (+10.6%)
G&A ($)$44,742,000 $81,569,000 +$36,827,000 (+82.3%)
Net Loss ($)−$78,502,000 −$130,394,000 −$51,892,000 (−66.1%)
Cash & Equivalents (12/31) ($)$83,679,000 $176,479,000 +$92,800,000 (+110.9%)

KPIs / Operating Highlights

KPIQ2–Q3 Prior MentionsQ4 2024
ASCENT PH-ILD dosing/tolerabilityObjective to inform dosing/tolerability; posters and ongoing enrollment Majority titrated to ≥15 breaths by week 8; early efficacy 6MWD +26.4m (n=20)
L606 dosingMax dose comparable to 26–28 Tyvaso breaths 4x/day; twice-daily administration Participants titrated to max dose BID; aiming pivotal PH-ILD study by year-end

Guidance Changes

No formal quantitative guidance (revenue, EPS, margins, OpEx, tax rate, segment) was issued in the Q4 press release or call; management focused guidance on regulatory timeline (final approval request and expected timing) and commercial readiness.

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue/EPSFY2025Not providedNot providedMaintained non-guidance
Regulatory timingMay 2025Targeting post-exclusivity approvalRequest for final approval around Mar 24; approval on/near May 23Clarified timeline
Financing2025+HCRx $100M funded by 2024Up to $100M more ($25M closed; $50M at first sale; $25M at >$100M net sales by 6/30/26)Increased capacity

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024, Q3 2024)Current Period (Q4 2024)Trend
Regulatory/legalQ2: Clear legal path; injunctions denied ; Q3: favorable Supreme Court outcome; exclusivity gating until 5/23/2025 No legal barriers remain; plan Class 1 resubmission; expect approval on/near 5/23/2025 Improving clarity
Commercial readinessSales force expansion; payer engagement Team “locked and loaded”; adequate for two indications; potential upsize in 2026 Strengthening
Treprostinil Injection dynamicsLower sales due to pump constraints Pump availability remains a headwind to promotion revenue Persistent headwind
L606 programATS poster; twice-daily, lower Cmax Ongoing open-label safety; aiming pivotal PH-ILD initiation by year-end Advancing
PH-ILD clinical narrativeBuilding ASCENT for dosing/tolerability Early ASCENT efficacy (+26.4m 6MWD); rapid titration to ≥15 breaths; strong KOL interest Strengthening
Financing/capitalEquity + HCRx funded $100M in 2024 Additional up to $100M via HCRx to support launch and runway Strengthened

Management Commentary

  • CEO on approval path: “We plan to request final approval in the coming weeks … to be granted final approval around May 23.”
  • CEO on ASCENT efficacy: “Mean change in baseline improved by 26.4 meters … highly encouraged by this early efficacy data.”
  • CFO on runway and profitability: “We are optimistic these proceeds and a successful launch … could lead to our reaching profitability without the need for additional capital.”
  • CMO on L606 profile: “Twice a day dosing is an absolute game changer … systemic side effects continue … to be further abated.”
  • CCO on launch readiness: “The team … is absolutely ready to go … we think we’re well suited to launch … and potentially expand as we learn.”

Q&A Highlights

  • Approval timing/process: Management expects final approval “on or near” May 23, with a Class 1 resubmission letter targeted around March 24 .
  • PH-ILD market strategy: Focus on centers for immediate uptake and deeper community education to identify undiagnosed patients; aim to position YUTREPIA as “first choice prostacyclin” .
  • Payer coverage ramp: Medicare ~50%, commercial 30–40%, remainder other; confident in payer engagement but withheld detailed strategies .
  • L606 plans: Preparing to initiate the global pivotal PH-ILD study by year-end; ongoing safety data supportive .
  • Transition study: Plan to directly transition underserved Tyvaso/Tyvaso DPI patients to YUTREPIA to demonstrate dose-related outcome improvements .

Estimates Context

  • Q4 2024: Revenue $2.917M vs $4.598M consensus; EPS −$0.45 vs −$0.38 consensus — both misses, driven by pump constraints and elevated pre-launch OpEx and litigation costs *.
  • Q3 2024: Revenue beat ($4.448M vs $4.189M), EPS slightly missed (−$0.3878 vs −$0.374) as OpEx grew for commercialization *.
  • Q2 2024: Revenue/ EPS both missed amid pump-driven volume pressure and higher OpEx *.

Notes: Consensus from S&P Global. Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalyst: Final FDA approval for YUTREPIA is expected on/near May 23, 2025; company is procedurally aligned for immediate launch thereafter .
  • Differentiation narrative: ASCENT early data (6MWD +26.4m; rapid titration to ≥15 breaths) and label dose titration table are core competitive levers vs Tyvaso DPI .
  • Financing de-risks launch: Up to $100M additional HCRx capacity supports commercial rollout and reduces need for equity, potentially bridging to profitability if launch targets are met .
  • Street numbers likely to reset: Continued pump constraints and ramp OpEx suggest near-term estimates should reflect pre-approval run-rate; post-approval revenue/EPS assumptions should incorporate faster dose titration and retention benefits .
  • Watch payer/access updates: Initial coverage mix skewed to Medicare; ongoing payer work is progressing and will be critical to early share capture in PH-ILD .
  • Legal overhang limited: No current legal barrier to approval post-exclusivity; only ‘327 PH-ILD case remains without preliminary injunction, trial June 2025 .
  • Trading setup: Binary-date path into late May; constructive risk/reward if approval is timely and ASCENT data at ATS further validates differentiation .

S&P Global disclaimer: All consensus estimate figures and any values marked with an asterisk (*) were retrieved from S&P Global.