Liquidia's Q3 2025 Earnings Call: Contradictions Emerge on Payer Coverage, Patient Adds, and Litigation Impact

Date of Call: November 3, 2025

Financials Results

• Revenue: $51.7M net product sales of YUTREPIA in Q3 2025; grew $45.2M sequentially vs Q2 (company states it captured ~75% of reported market revenue growth); first full quarter post-launch

Guidance:

• Expect the positive net-cash and profitability trend to extend into 2026.
• Plan to reinvest in R&D while maintaining financial discipline.
• Initiate global pivotal RESPIRE study later this year with enrollment planned H1 2026.
• Run niche open-label studies (e.g., PAH transitions from oral prostacyclins) and evaluate proof-of-concept in IPF and PPF; explore PH-COPD and Raynaud's.
• Advance L606 sustained-release twice-daily inhaled treprostinil development.

Business Commentary:

• Strong Launch and Market Uptake of YUTREPIA:
• Liquidia Corporation reported over 2,000 unique prescriptions and initiated therapy for over 1,500 patients with YUTREPIA in its first five months of launch.

• The uptake was driven by the unique product profile of YUTREPIA, which offers advantages in ease, titratability, and tolerability compared to competing therapies.

• Financial Performance and Profitability:

• The company achieved $51.7 million in net product sales in its first full quarter of YUTREPIA launch, resulting in a positive adjusted EBITDA of $10.1 million.

• Profitability was reached sooner than expected, with significant contributions from the rapid adoption of YUTREPIA and strong cash management.

• Market Access and Payer Reimbursement:

• Liquidia has signed contracts with the three largest commercial payers, ensuring YUTREPIA is on equal footing with competitor products.

• Successful market access initiatives have led to an 85% referral-to-start ratio, indicating a strong pull-through, particularly with patient support services in place.

• Expansion of Indications and Clinical Strategy:

• The company is exploring new clinical studies to expand YUTREPIA's utility, including transitioning patients from oral therapies and treating IPF and PPF.
• This strategy aims to strengthen YUTREPIA's product profile and potentially expand its indications, driven by the desire to address unmet patient needs.

Sentiment Analysis:

Overall Tone: Positive

• CEO: 'YUTREPIA continued to exceed expectations' with >2,000 unique prescriptions and >1,500 patients initiated; CFO: 'delivered $51.7 million in net product sales' and 'positive adjusted EBITDA of $10.1 million' in first full quarter of launch; September was first month of positive net cash flow (+$5M).

Q&A:

• Question from Amy Li (Jefferies LLC): Congrats on the launch. What's driving the rapid uptake, the PAH vs PH-ILD breakdown, and your view on the trajectory of patient adds going forward?
  Response: Uptake is driven by YUTREPIA's product profile (ease, tolerability, device); majority of prescriptions are PAH with PH-ILD steadily growing; referral-to-start conversion ~85%, company sees an attractive runway but won't forecast future growth.

• Question from Cory Jubinville (LifeSci Capital, LLC): What percentage of revenues are from contracted vs non-contracted reimbursement, are you on the 3 major PBM formularies, and what drove rapid conversion of volume to recognized revenue?
  Response: Company has signed commercial contracts with the three largest payers and begun rebate activity; Medicare Part D has no contracting; removal of new-to-market blocks and strong patient support services drove ~85% referral-to-start pull-through enabling rapid revenue conversion.

• Question from Julian Harrison (BTIG, LLC): Of the ~1,500 patients, how many were in the 28-day voucher period and what's average time from prescription to shipment?
  Response: Average prescription-to-fill is typically within a few weeks; from launch to date slightly over 50% of new patients have used the 28-day voucher program.

• Question from Ryan Deschner (Raymond James & Associates, Inc.): How is channel loading trending into Q3/October and what's the split between naïve and treprostinil-experienced patients?
  Response: Channel inventory has normalized at SPs (~3–4 weeks); patient mix is ~75% new to prostacyclins and ~25% transitioning, and sequential revenue growth Q2→Q3 was ~$45.2M (company captured ~75% of market growth).

• Question from Serge Belanger (Needham & Company, LLC): When do you expect steady-state coverage, any headwinds from competitor contracts, and expand on plans for IPF/PPF?
  Response: Signed contracts with the three largest commercial payers and new-to-market blocks are being removed; no material headwind expected from competitor contracting; company is actively evaluating IPF/PPF proof-of-concept studies based on positive signals (TETON-2) and dose-response data.

• Question from Andrew Fein (H.C. Wainwright & Co, LLC): How should we read the robust commercial uptake into the ongoing litigation with United Therapeutics and might that impact the judge's view?
  Response: Physicians prioritize patient benefit and largely ignore litigation; company sees no evident commercial impact of the litigation on uptake to date.

• Question from Benjamin Burnett (Wells Fargo Securities, LLC): Any update on timing of the judge's decision and what should we expect to see in the opinion?
  Response: Timing is uncertain (could be in the coming window up to early Q1); initial opinion will likely state who prevailed, with remedies (if any) to be addressed subsequently and potentially litigated.

• Question from Jason Gerberry (BofA Securities): Could a royalty be a possible remedy instead of removing ILD from the label, and is it reasonable to expect ≥2,000 paid patients in 2026?
  Response: Remedies could range from market removal to a royalty depending on which claims are found infringed; the company will not forecast patient counts but highlights strong early uptake and an 85% pull-through rate.

Contradiction Point 1

Payer Coverage and Reimbursement

It involves the progression of payer coverage and reimbursement agreements, which are crucial for market access and patient affordability.

What percentage of revenues are from contracted versus noncontracted reimbursement, and are you listed on the formularies of the top three PBMs? - Cory Jubinville (LifeSci Capital, LLC, Research Division)

2025Q3: We have contracts with the 3 major commercial payers, and new-to-market blocks have been removed or will be removed soon. Medicare Part D is on equal footing, and we feel we've achieved patient choice without contractual barriers. - Michael Kaseta(CFO)

Can you break down the $6.5 million YUTREPIA revenue between channel inventory and patient demand? What is your current payer coverage and expected coverage by next quarter? - Serge D. Belanger (Needham)

2025Q2: Payer coverage aims for parity with TYVASO. - Michael Kaseta(CFO)

Contradiction Point 2

Patient Adds and Market Demand

It concerns the market demand and patient adoption of YUTREPIA, which is critical for revenue growth and product success.

How many of the 1,500 patients on YUTREPIA as of last week were in the 28-day voucher period? And what is the average time from prescription to YUTREPIA shipment to a patient? - Julian Harrison (BTIG, LLC, Research Division)

2025Q3: The average time from prescription to fill is usually within a few weeks. Over 50% of new patients have used the 28-day voucher program, showing a high trial rate. - Michael Kaseta(CFO)

What percentage of patient starts are associated with paid prescriptions, and does this align with expectations? What percentage of patient starts represent switches from TYVASO DPI or other treprostinil products? - Ryan Phillip Deschner (Raymond James)

2025Q2: Less than 50% of drug is free, aligning with expectations. Free drug includes initial 28-day vouchers and bridge program supplies. - Michael Kaseta(CFO)

Contradiction Point 3

Litigation and Market Impact

It involves the impact of litigation on the commercial environment, which can affect market dynamics and product acceptance.

How does the litigation with United Therapeutics impact the commercial environment and litigation outcome? - Andrew Fein (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: The litigation does not significantly affect the commercial environment as physicians focus on patient benefit. - Roger Jeffs(CEO)

Where is payer coverage currently and where is it projected to be by next quarter? - Serge D. Belanger (Needham)

2025Q2: In the coming months, we anticipate that the court will issue a decision on the post-trial motions for our patent case with United Therapeutics. - Russell Schundler(CLO)

Contradiction Point 4

Strategic Focus on IPF and PPF

It involves strategic focus areas for the company, impacting potential market expansion and product development priorities.

Can you update on payer coverage and plans for YUTREPIA usage in IPF and PPF? - Serge Belanger (Needham & Company, LLC, Research Division)

2025Q3: Regarding IPF and PPF, we are interested in exploring these areas due to potential advantages in dose, titratability, and tolerability. - Michael Kaseta(COO) and Rajeev Saggar(CMO)

How will the company address supply chain disruptions impacting production and revenue projections? - Jason Adair (Liquidia Corporation)

2025Q1: We believe that YUTREPIA's differentiated product profile positions us to potentially capture a share of these near-term opportunities. - Roger Jeffs(CEO)

Contradiction Point 5

Payer Coverage and Market Access

It involves differing perspectives on the coverage and access to YUTREPIA, which impacts market penetration and patient accessibility to the drug.

What percentage of revenue comes from contracted vs. noncontracted reimbursement? Are you included in the top three PBMs' formularies? - Cory Jubinville (LifeSci Capital, LLC, Research Division)

2025Q3: We have contracts with the 3 major commercial payers, and new-to-market blocks have been removed or will be removed soon. Medicare Part D is on equal footing, and we feel we've achieved patient choice without contractual barriers. - Michael Kaseta(COO & CFO)

Can you provide the distribution of commercial and Medicare coverage for PAH and PH-ILD? What is the expected coverage expansion for commercial and Medicare over the next 12 months? - Serge Belanger (Needham & Company, LLC, Research Division)

2024Q4: Generally, Medicare accounts for 50% of coverage, with 30% to 40% commercial and the remainder being Medicare, other DoD, et cetera. Details on coverage ramp-up strategy are not disclosed, but collaboration with payers to maximize access is emphasized. - Scott Moomaw(CMO)