Liquidia Corporation Reports Third Quarter 2026 Financial Results
- YUTREPIA® (treprostinil) inhalation powder net product sales of
$222.7 million in the third quarter of 2026, up 31% from the second quarter of 2026 October 2026 total patient shipments reached their highest monthly level since launch- Resolved all litigation with United Therapeutics through a global settlement, securing continuity of care for all patients treated with YUTREPIA
- Recorded net loss of
$236.3 million reflects a$389.7 million litigation settlement charge - Fifth consecutive quarter of increasing non-GAAP, adjusted EBITDA to
$140.5 million - Increased cash and cash equivalents to
$396.1 million prior to settlement payments - Granted Fast Track designation for YUTREPIA for the treatment of SSc-RP and initiated RE-WARM, a Phase 2 randomized open-label dose-finding study
Dr.
YUTREPIA Commercial Highlights (as of
- Net product sales of
$222.7 million in the third quarter of 2026. $212.2 million in paid patient demand in the third quarter of 2026, excluding voucher and patient access programs, reflecting growing patient demand.- From launch through
September 2026 , more than 60% of referrals included a PAH diagnosis, rising to more than 70% in September. - In
October 2026 , total patient shipments reached their highest monthly level since launch. - In
October 2026 , the daily referral rate was more than 75% of the daily referral rate for the third quarter. - Conversion of monthly referrals to patient starts remained above 87%.
- Prescriber base reached 1,300 through October, adding more first-time prescribers in
October 2026 thanSeptember 2026 . - Roughly 60% of YUTREPIA prescribers have written for two or more patients, and more than 30% have written for at least five patients.
- 77% of YUTREPIA prescribers have written a PAH prescription since launch.
Clinical Pipeline Updates
YUTREPIA
- Initiated LTI-403, an open-label study to evaluate safety and tolerability of YUTREPIA in adults with PAH who switch from oral selexipag; anticipate primary study completion in 2Q2027.
- Advanced SPRINT, an open-label trial to evaluate the hemodynamic response measured by changes in pulmonary vascular resistance (PVR) following 16 weeks of treatment dosed three or four times daily; anticipate initiation in 4Q2026.
- Advanced EASY-PAH, a prospective, observational
U.S . registry of YUTREPIA to evaluate dose regimen, including frequency, titration, and longitudinal clinical endpoints; anticipate initiation in 2027. - Enrolled first patient in RE-WARM, a Phase 2 randomized open-label dose-finding study to evaluate safety, tolerability and pharmacodynamics of YUTREPIA in adults with systemic sclerosis (SSc) experiencing frequent symptomatic Raynaud's phenomenon (RP) attacks; anticipate primary study completion in 1Q2027. In
September 2026 , FDA granted Fast Track designation to the program, underscoring the significant unmet need and lack of approved treatments.
L606
- Continued enrollment in Re-Spire, a global pivotal placebo-controlled efficacy study to evaluate L606 in adults for the treatment of PH-ILD. Anticipate enrollment to be completed in 2028 and primary study to be completed in 2029.
- Advanced AMPLIFY-PAH, a pivotal study to evaluate the safety and efficacy of L606 in adults with PAH. Anticipate enrollment to be initiated in 2027 and primary study to be completed in 2029.
- Advanced preparations for a pivotal study to evaluate the safety and efficacy of L606 in adults with PH-COPD. Anticipate initiation in the second half of 2027.
Global Settlement with United Therapeutics
On
Under the settlement agreement,
Third Quarter 2026 Financial Results
Net loss for the third quarter of 2026 was
Cash and cash equivalents totaled
Product sales, net, were
Service revenue, net and cost of service revenue, were
Cost of product sales was
Research and development expenses were
Selling, general and administrative expenses were
Litigation settlement, net was
Interest expense, net was
Income tax benefit was
Net loss for the three months ended
Webcast Information
About YUTREPIA® (treprostinil) Inhalation Powder
YUTREPIA is an inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. YUTREPIA was designed using Liquidia’s PRINT® technology, which enables the development of drug particles that are precise and uniform in size, shape and composition, and that are engineered for enhanced deposition in the lung following oral inhalation. YUTREPIA is approved and marketed for the treatment of pulmonary arterial hypertension (PAH). YUTREPIA is not approved for the treatment of systemic sclerosis-associated Raynaud’s phenomenon (SSc-RP); it has received Fast Track designation from the FDA for SSc-RP. YUTREPIA was previously referred to as LIQ861 in investigational studies.
About L606 (liposomal treprostinil inhalation suspension)
L606 is an investigational, extended-release formulation of treprostinil administered twice daily with a next-generation nebulizer. The L606 suspension uses a proprietary liposomal formulation to encapsulate treprostinil which can be released slowly at a controlled rate into the lung, enhancing drug exposure over an extended period of time. L606 is currently being evaluated in an open-label study in
About Pulmonary Arterial Hypertension (PAH)
PAH is a rare, chronic, progressive disease caused by hardening and narrowing of the pulmonary arteries that can lead to right heart failure and eventually death. Currently, more than 50,000 estimated patients are diagnosed and treated in the United States. There is currently no cure for PAH, so the goals of existing treatments are to alleviate symptoms, maintain or improve functional class, delay disease progression and improve quality of life.
About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
PH-ILD includes a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, connective tissue disease-related ILD, and chronic pulmonary fibrosis with emphysema (CPFE) among others. Any level of PH in ILD patients is associated with poor 3-year survival. A current estimate of PH-ILD prevalence in the United States is greater than 60,000 patients, though actual prevalence in many of these underlying ILD diseases is not yet known due to factors including underdiagnosis and lack of approved treatments until March 2021 when inhaled treprostinil was first approved for this indication.
About
Abbreviations
1. PAH: pulmonary arterial hypertension. 2. PH-ILD: pulmonary hypertension associated with interstitial lung disease. 3. SSc-RP: systemic sclerosis-associated Raynaud’s phenomenon. 4. PH-COPD: pulmonary hypertension associated with chronic obstructive pulmonary disease.
Cautionary Statements Regarding Forward-Looking Statements
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements.
Forward-looking statements, including statements regarding the settlement agreement and its anticipated benefits; timing and outcome of FDA review of the Prior Approval Supplement to remove the PH-ILD indication from the YUTREPIA label; the impact of ceasing PH-ILD promotion and sales on YUTREPIA revenue; continued availability of YUTREPIA for patients; clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs); regulatory applications and related submission contents and timelines; our future results of operations, financial position and cash resources; our estimates regarding future expenses, capital requirements and needs for additional financing; potential revenue and profitability of YUTREPIA; and our development plans for L606 and for YUTREPIA in SSc-RP, PH-COPD or other indications, are forward-looking statements. These statements involve significant risks and uncertainties, and actual results could differ materially from those expressed or implied herein. Among other things, the settlement agreement does not extend to indications other than PAH or to new treprostinil-containing products, and United Therapeutics may assert patents against our development programs or future products. Fast Track designation does not guarantee that YUTREPIA will receive FDA approval for the treatment of SSc-RP or that development will proceed on the anticipated timeline. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our filings with the
Use of Non-GAAP Financial Information
This press release and the accompanying tables include
Contact Information
Investors:
Chief Business Officer
919.328.4350
Jason.adair@liquidia.com
Media:
media@liquidia.com
Select Consolidated Balance Sheet Data
(in thousands)
| 2026 | 2025 | |||||||
| Cash and cash equivalents | $ | 396,091 | $ | 190,680 | ||||
| Total assets | $ | 682,942 | $ | 327,934 | ||||
| Total liabilities | $ | 708,376 | $ | 283,186 | ||||
| Accumulated deficit | $ | (735,057 | ) | $ | (626,313 | ) | ||
| Total stockholders’ (deficit) equity | $ | (25,434 | ) | $ | 44,748 | |||
Consolidated Statements of Operations and Comprehensive Income (Loss)
(unaudited)
(in thousands, except share and per share amounts)
| Three Months Ended |
||||||||
| 2026 | 2025 | |||||||
| Revenues: | ||||||||
| Product sales, net | $ | 222,744 | $ | 51,669 | ||||
| Service revenue, net | 2,556 | 2,673 | ||||||
| Total revenue | 225,300 | 54,342 | ||||||
| Costs and expenses: | ||||||||
| Cost of product sales | 13,985 | 2,295 | ||||||
| Cost of service revenue | 792 | 878 | ||||||
| Research and development | 25,269 | 9,346 | ||||||
| Selling, general and administrative | 59,024 | 40,056 | ||||||
| Litigation settlement, net (inclusive of |
389,749 | — | ||||||
| Total costs and expenses | 488,819 | 52,575 | ||||||
| (Loss) income from operations | (263,519 | ) | 1,767 | |||||
| Interest expense, net | (2,880 | ) | (5,300 | ) | ||||
| Loss before income taxes | (266,399 | ) | (3,533 | ) | ||||
| Income tax benefit | (30,071 | ) | — | |||||
| Net loss and comprehensive loss | $ | (236,328 | ) | $ | (3,533 | ) | ||
| Net loss per common share, basic and diluted | $ | (2.64 | ) | $ | (0.04 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 89,521,467 | 86,333,772 | ||||||
About Non-GAAP Financial Information
To supplement our financial results presented in accordance with
Adjusted EBITDA is a non-GAAP measure that represents net income for the period before the impact of interest income, interest expense, other income and expense, income taxes, depreciation and amortization, and certain items that impact comparison of the performance of our business either period-over-period or with other businesses.
Adjusted EBITDA should not be considered in isolation or as a substitute to net income or any other measure of financial performance calculated and presented in accordance with GAAP. Our calculation of Adjusted EBITDA may not be comparable to similarly titled measures of other companies because other companies may not calculate them in the same manner as we calculate these measures.
For a reconciliation of such non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with GAAP, please see the table titled “Reconciliation of Non-GAAP Financial Information” below.
Reconciliation of Non-GAAP Financial Information
Reconciliation of Net Loss to Adjusted EBITDA
(unaudited)
(in thousands)
| Three Months Ended | ||||
| 2026 | ||||
| Net loss | $ | (236,328 | ) | |
| Interest expense, net | 2,880 | |||
| Income tax benefit | (30,071 | ) | ||
| Depreciation and amortization | 545 | |||
| EBITDA | $ | (262,974 | ) | |
| Litigation settlement, net | 389,749 | |||
| Stock-based compensation | 13,678 | |||
| Adjusted EBITDA | $ | 140,453 | ||
Source: Liquidia Technologies, Inc.