Full Press Release Details
Liquidia Corporation Announces Preliminary
Full-Year 2025 YUTREPIA Net Sales and Corporate Update
MORRISVILLE, N.C., January 9,
2026 - Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company driven by science and compassion to revolutionize
care for patients with challenging respiratory and vascular diseases, today announced preliminary, unaudited full-year 2025 net product
sales of YUTREPIA (treprostinil) inhalation powder, as well as updates on the commercial launch and the clinical pipeline. These
updates will be discussed during Liquidia's participation in the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12-14,
2026, in San Francisco. The Company plans to report fully audited financial results for the year ended December 31, 2025, in February 2026.
Dr. Roger Jeffs, Liquidia's Chief
Executive Officer, said: "2025 marked a transformational year for Liquidia, with the successful commercial launch of YUTREPIA across
both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) patient populations.
We are encouraged by the continued momentum in adoption, which reflects strong execution by our team and growing physician confidence
in YUTREPIA as a differentiated and increasingly preferred inhaled prostacyclin option.
Looking ahead to 2026, we are excited to build
on this foundation by advancing clinical programs to further differentiate YUTREPIA and L606, our extended-release treprostinil formulation,
across current and potential future indications, like IPF, PPF, and PH-COPD, where there remains a significant unmet need. We believe
YUTREPIA and L606 have the potential to establish a new standard for the use of inhaled prostacyclin as a critical therapeutic modality
across these serious and progressive diseases."
Full-Year 2025 Financial Highlights (preliminary,
YUTREPIA Commercial Launch Highlights (as
of December 31, 2025)
In 2026, Liquidia will continue investing
in clinical development to further strengthen the medical evidence supporting YUTREPIA and L606, including:
Dr. Roger Jeffs, Chief Executive Officer of Liquidia, will present
at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 5:15 p.m. PT (8:15 p.m. ET). The
webcast will be available on Liquidia's website at https://liquidia.com/investors/events-and-presentations.
A rebroadcast of the event will be available and archived for a period of 30 days at the same location.
About YUTREPIA (treprostinil) Inhalation Powder
YUTREPIA is an inhaled dry-powder formulation of treprostinil
delivered through a convenient, low-effort, palm-sized device. YUTREPIA is indicated for the treatment of pulmonary arterial
hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability.
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 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 the United States for treatment of pulmonary arterial hypertension
(PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) and a global pivotal placebo-controlled efficacy
study for the treatment of PH-ILD.
About Treprostinil Injection
Treprostinil Injection is the first-to-file,
fully substitutable generic treprostinil for parenteral administration. Treprostinil Injection contains the same active ingredient, same
strengths, same dosage form and same inactive ingredients as Remodulin (treprostinil) and is offered to patients and physicians with
the same level of service and support, but at a lower price than the branded drug. Liquidia PAH promotes the appropriate use of Treprostinil
Injection for the treatment of PAH in the United States in partnership with its commercial partner, Sandoz, who holds the Abbreviated
New Drug Application (ANDA) with the FDA.
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (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, an estimated 45,000 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)
Pulmonary hypertension (PH) associated with interstitial lung disease (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 Liquidia Corporation
Liquidia Corporation is a biopharmaceutical
company driven by science and compassion to revolutionize care for patients with challenging respiratory and vascular diseases through
precise, innovative therapies and applications of its proprietary PRINT Technology. PRINT enabled the creation of Liquidia's
first approved product, YUTREPIA (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH) and
pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational
extended-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic
Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.
Tyvaso , Tyvaso DPI and Remodulin
are registered trademarks of United Therapeutics Corporation.
Uptravi is a registered trademark of
Actelion Pharmaceuticals Ltd.
Winrevair is a registered trademark of
Merck Sharp & Dohme LLC.
Cautionary Statements Regarding Forward-Looking
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.
The estimated preliminary financial results
for the fourth quarter and fiscal year ended December 31, 2025 contained in this press release contain forward-looking statements
that are based on information available to the Company as of the date of this release. The Company's financial closing and review
procedures for the fourth quarter and full year 2025 are not yet complete, and actual results may differ from these preliminary estimates
as a result of final accounting adjustments, the completion of internal control processes, and other developments that may arise prior
to the finalization of the Company's financial statements. The preliminary financial results included in this release have not been
audited or reviewed by the Company's independent registered public accounting firm and should not be considered a substitute for
the Company's full interim or annual financial statements. Accordingly, undue reliance should not be placed on this preliminary
Forward-looking statements, including statements
regarding the estimated preliminary financial
results referred to above, 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, the timelines or outcomes
related to patent litigation with United Therapeutics in the U.S. District Court for the District of Delaware and U.S. District Court
for the Middle District of North Carolina, or other litigation between Liquidia and United Therapeutics or others, including rehearings
or appeals of decisions in any such proceedings, the issuance of patents by the USPTO and our ability to execute on our strategic or financial
initiatives, our estimates regarding future expenses, capital requirements and needs for additional financing, and potential revenue and
profitability of YUTREPIA involve significant risks and uncertainties and actual results could differ materially from those expressed
or implied herein. Our ability to maintain YUTREPIA's approval and to continue commercialization of YUTREPIA remain subject to ongoing
litigation in which United Therapeutics is seeking injunctive relief, which could block our ability to continue to sell YUTREPIA for one