Executive Summary

Q1 2025 revenue of $3.12M and EPS of -$0.45 declined year over year and missed Street estimates (Rev: $3.23M; EPS: -$0.40); operating loss was -$35.4M as commercialization prep ramped ahead of YUTREPIA launch . Estimates from S&P Global.
Management highlighted no current legal barriers to final FDA approval following expiration of Tyvaso DPI exclusivity on May 23; FDA accepted the NDA resubmission on Mar 28, and YUTREPIA received approval on May 23, 2025, creating an immediate commercialization catalyst .
Cohort A of the ASCENT PH-ILD study fully enrolled (>50 patients); early data suggest rapid up-titration and tolerability with positive 6-minute walk trends, supporting differentiation versus incumbent formulations .
Balance sheet cash was $169.8M at quarter-end; Liquidia amended its HCR agreement to access up to $100M incremental funding to support launch and pipeline programs .
Post-quarter, UTHR filed a new patent complaint (‘782), seeking to enjoin commercialization; Liquidia emphasized this does not impact FDA’s ability to approve and is preparing to defend commercialization plans .

What Went Well and What Went Wrong

What Went Well

YUTREPIA regulatory momentum: FDA accepted the Class 1 resubmission with a May 24 PDUFA date; final approval was granted May 23, unlocking the launch path .
Clinical execution: ASCENT Cohort A fully enrolled (>50 PH-ILD patients) with tolerability and titratability consistent with INSPIRE; patients titrated to doses ~3x higher than nebulized Tyvaso labeled target, with positive trends in 6MWD .
Commercial readiness: Sales force (~50 reps) and medical affairs team in place; product availability planned in-channel 2–3 weeks post-approval; payer access strategy emphasized .
- CEO: “we are proud to say there continue to be no legal barriers barring YUTREPIA's potential final approval following the expiration of gating regulatory exclusivity on May 23, 2025” .

What Went Wrong

Financial pressure: G&A rose 48% YoY to $30.1M with higher headcount, legal fees, and infrastructure; net loss widened to -$38.4M and other expense increased on higher HCR borrowings .
Top-line softness: Revenue of $3.12M modestly increased YoY (+$0.15M) but missed consensus ($3.23M), reflecting lower sales volumes in the Treprostinil Injection promotion and gross-to-net dynamics . Estimates from S&P Global.
Ongoing litigation risk: UTHR’s May 9 ‘782 patent complaint seeks to block commercialization despite FDA approval; TRO/PI motion was argued May 20 and remains pending, injecting launch uncertainty .

Financial Results

Summary vs Prior Periods and Estimates

Metric	Q3 2024	Q4 2024	Q1 2025	Vs PY (Q1’24)	Vs Est. (Q1’25)
Revenue ($USD)	$4.448M	$2.917M*	$3.120M	$2.972M → $3.120M (+$0.148M YoY)	$3.23M est vs $3.120M actual → Miss (−$0.11M)
Net Loss ($USD)	$(23.155)M	$(38.369)M*	$(38.367)M	$(30.083)M → $(38.367)M (worse)	N/A
EPS ($USD)	$(0.30)	$(0.453)*	$(0.45)	$(0.40) → $(0.45) (worse)	$(0.40) est vs $(0.45) actual → Miss

Values marked with * were retrieved from S&P Global.

Operating Metrics

Metric ($USD)	Q3 2024	Q4 2024	Q1 2025
Loss from Operations	$(29.189)M	$(36.107)M*	$(35.425)M
R&D Expense	$11.890M	N/A	$6.966M
G&A Expense	$20.182M	N/A	$30.062M
Cash & Equivalents (period-end)	$204.368M	$176.479M	$169.758M

Values marked with * were retrieved from S&P Global.

Segment/Revenue Mix

No reportable segments; revenue primarily from the Sandoz Promotion Agreement sharing profits from Treprostinil Injection sales .

KPIs

Total other expense, net: $(2.942)M (higher interest expense due to greater HCR borrowings) .
Total liabilities: $177.716M; Equity: $49.713M .
Financial statement revision: immaterial corrections related to HCR amendments eliminated prior loss on extinguishment and adjusted interest expense .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance (Revenue, EPS, margins)	FY/Q2 onward	None	None issued	Maintained (no formal guidance)
Funding availability (HCR facility)	2025+	Prior HCR capacity	Up to $100M additional (3 tranches: $25M at closing; $50M upon first commercial sale; $25M upon >$100M cumulative YUTREPIA net sales before Jun 30, 2026)	Raised funding access
Regulatory milestones	May 2025	PDUFA set for May 24	FDA approved YUTREPIA May 23	Achieved approval

Earnings Call Themes & Trends

Topic	Q3 2024 (Q-2)	Q4 2024 (Q-1)	Q1 2025 (Current)	Trend
Regulatory/legal	FDA tentative approval; exclusivity gating; lawsuit to vacate TYVASO DPI exclusivity	Plan to request final approval near 3/24; “no legal barriers” after 5/23	Court dismissed UTHR cross-claim on PH-ILD NDA amendment; no proceeding enjoining approval/launch at time of call	Improving pathway; lingering UTHR actions post-quarter (‘782)
Product profile (YUTREPIA)	Differentiation via PRINT and low-resistance device; rapid titration	Early ASCENT 6MWD +26.4m at 8 weeks in first 20; higher doses	ASCENT Cohort A fully enrolled; 3x target dose; positive trends; Cohort B transition study planned	Strengthening clinical narrative
Commercial readiness	Sales force and KADs sized for centers & community; payer engagement	“Locked and loaded” team; potential expansion in 2026; supply secured	50 reps; channel fill within 2–3 weeks of approval; broad payer access expected	Ready to execute
Payer/access mix	Noted Medicare/commercial balance	Expect 50% Medicare, 30–40% commercial, others remainder	Similar mix expectation: ~50% Medicare, 35% commercial, 10% Medicaid, 5% other	Consistent expectations
R&D execution (L606)	Global pivotal plan; device rights expanded	Initiate global placebo-controlled study by year-end; twice daily benefits	Working to initiate global study by year-end; ~300+ patients; multi-country	Progressing toward pivotal

Management Commentary

“We are doubling down on our preparations for the potential launch of YUTREPIA with a laser focus on 5 key strategic areas… product profile… share of voice… patient support services… robust product availability… broad payer access.”
“Mike and his team… prepared to put product in the channel in only 2 to 3 weeks after YUTREPIA's potential approval.”
CFO on the quarter: immaterial revision related to HCR accounting adjustments; net loss -$38.4M; G&A up on commercialization and legal .
CMO on ASCENT: PH-ILD patients titrated to 2–3x equivalent TYVASO doses within weeks with encouraging tolerability and exploratory efficacy signals .

Q&A Highlights

Legal backdrop: No active proceeding enjoining FDA approval or launch at the time of call; dismissal without prejudice limits UTHR’s ability to reassert same arguments; Liquidia prepared to respond to any future actions .
Transition strategy: Cohort B will directly transition patients dissatisfied with TYVASO/TYVASO DPI to YUTREPIA to demonstrate dosing and clinical benefit differences .
Market approach: Initial focus on new patient starts, then transitions—particularly residual nebulized TYVASO patients (~31% of scripts), with data to support better tolerability/titration .
Prescriber/patient support: Team with decade-plus prostacyclin experience; support program designed to be “as good as or better” than current market standards .
Payer mix expectations: ~50% Medicare, ~35% commercial, ~10% Medicaid, ~5% other .

Estimates Context

Q1 2025 consensus vs actual (S&P Global):
- Revenue: $3.23M est vs $3.12M actual → Miss
- EPS: -$0.40 est vs -$0.45 actual → Miss
- Estimates count: EPS (8), Revenue (8)

Metric	Q1 2025 Estimate	Q1 2025 Actual
Revenue ($USD)	$3.225M	$3.120M
Primary EPS ($USD)	-$0.40	-$0.45
EPS - # of Estimates	8	N/A
Revenue - # of Estimates	8	N/A

Values retrieved from S&P Global for estimates; actuals from company press release .

Key Takeaways for Investors

Near-term catalyst realized: FDA approval on May 23 positions YUTREPIA for immediate launch; watch for court rulings on UTHR’s TRO/PI and ‘782 litigation that could affect timing or at-risk considerations .
Differentiation narrative is strong: ASCENT signals rapid up-titration, tolerability, and early functional gains, supporting share capture from new starts and transitions, including residual nebulized base .
Execution readiness: Sales force, supply chain, and payer engagement appear in place; management targets channel fill within weeks of approval and broad access .
Financial ramp vs burn: G&A elevated ahead of launch; cash of $169.8M and expanded HCR facility provide runway to support commercialization and L606, but monitor operating losses until revenue inflects .
Litigation watch: While approval is secured, UTHR’s ongoing suits could create volatility; management indicates no valid, infringed patents would deter launch decisions, but outcomes may impact pacing or economics .
Estimates likely to adjust: Q1 miss reflects pre-launch economics; Street should reframe models for launch trajectory, payer mix, and transition dynamics in PH-ILD and PAH.
Medium-term thesis: If clinical differentiation translates into persistency and dosing advantages, YUTREPIA could compete across a ~$4B inhaled/oral prostacyclin landscape; L606 offers a potential next-gen twice-daily option over multi-year horizon .

Values marked with * in tables were retrieved from S&P Global.

Citations:

Q1 2025 press release and financials .
8-K Item 2.02 and Exhibit 99.1 .
FDA NDA resubmission acceptance (Mar 28) .
FDA approval (May 23) .
Litigation update (May 12) .
Q1 2025 earnings call transcript .
Q4 2024 call (data context) .
Q3 2024 press release and call (trend context) .

Liquidia Corp (LQDA)·Q1 2025 Earnings Summary