Full Press Release Details
Liquidia Corporation Reports Third Quarter
2025 Financial Results and Provides Corporate Update
N.C., November 3, 2025 - 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 its financial results
for the third quarter ended September 30, 2025. The company will also host a webcast at 8:30 a.m. Eastern Time on
November 3, 2025, to review financial performance and provide a corporate update.
Jeffs, Liquidia's Chief Executive Officer, said: "Our third quarter results demonstrate
the continued momentum of YUTREPIA's launch and the clear enthusiasm from both prescribers and patients. As of October 30,
2025, we have received more than 2,000 unique prescriptions and shipped to more than 1,500 patients, supported by over 600 prescribers
nationwide. As our real-world evidence continues to grow and access broadens, we continue to believe in YUTREPIA's potential to
become the preferred inhaled prostacyclin to treat patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated
with interstitial lung disease (PH-ILD). With the strong foundation established in our first full quarter post-launch, we are well positioned
to pursue sustained growth and continued profitability, while thoughtfully investing in programs to expand YUTREPIA's therapeutic
profile and advance L606 into pivotal trials."
Third Quarter 2025 Financial Results
Company recorded a net loss of $3.5 million in third quarter of
2025 compared to net loss of $31.0 million in the prior year quarter. The first full quarter of YUTREPIA sales led to profitability
with $1.7 million in operating income and positive non-GAAP adjusted EBITDA of $10.1 million.
equivalents totaled $157.5 million as of September 30, 2025, compared to $176.5 million as of December 31,
sales, net, were $51.7 million for the three months ended September 30, 2025. We began shipping
YUTREPIA to our customers in the United States in June 2025 following receipt of full FDA approval for YUTREPIA on May 23, 2025.
We did not recognize any product sales during 2024.
Service revenue, net, was $2.7 million for
the three months ended September 30, 2025, compared to $4.4 million for the three months ended September 30, 2024.
Service revenue, net related primarily to the promotion agreement with Sandoz, Inc. pursuant to which we share profits from the sale
of Treprostinil Injection in the United States (Promotion Agreement). The decrease of $1.7 million was primarily
due to lower sales volumes in the current quarter.
sales was $2.3 million for the three months ended September 30, 2025 and related to sales of YUTREPIA. We
did not record any cost of product sales during 2024.
revenue was $0.9 million for the three months ended September 30, 2025, compared to $1.6 million for the three months ended September 30,
2024. The decrease from 2024 to 2025 reflects a lower of allocation of the cost of our commercial field force to Treprostinil Injection
resulting from the commercial launch of YUTREPIA in the second quarter of 2025.
Research and development expenses were $9.3 million for the three months
ended September 30, 2025, compared to $11.9 million for the three months ended September 30, 2024. The decrease of
$2.6 million or 21% was primarily due to a $3.2 million decrease in personnel expenses (including stock-based compensation) due to a shift
from activities related to research and development to the commercialization of YUTREPIA and a $0.8 million decrease in facilities and
infrastructure expenses. These decreases were offset by a $1.5 million increase in clinical expenses for our L606 program, primarily related
to our planned global pivotal study for the treatment of PH-ILD.
Selling, general and administrative expenses were $40.1 million for
the three months ended September 30, 2025, compared to $20.2 million for the three months ended September 30, 2024.
The increase of $19.9 million or 98% was primarily due to a $10.2 million increase in personnel expenses (including stock-based compensation)
driven by higher headcount and a shift from activities related to research and development to the commercialization of YUTREPIA, a $6.3
million increase in commercial and consulting expenses to support the commercialization of YUTREPIA, a $1.3 million increase in legal
fees related to our ongoing YUTREPIA-related litigation, and a $1.3 million increase in facilities and infrastructure expenses.
Total other expense, net was $5.3 million for the three months ended
September 30, 2025, compared with $1.8 million for the three months ended September 30, 2024. The increase of $3.5
million was primarily attributable to the higher borrowings under the HCR Agreement.
the three months ended September 30, 2025, was $3.5 million or $0.04 per basic and diluted share, compared to
a net loss of $31.0 million, or $0.40 per basic and diluted share, for the three months ended September 30,
will host a live webcast at 8:30 a.m. Eastern Time on November 3, 2025, to discuss the second quarter financial results
and corporate update. 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 one year at the same location.
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.
L606 (liposomal treprostinil) Inhalation Suspension
L606 is an investigational, sustained-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) with a planned global pivotal placebo-controlled
efficacy study for the treatment of PH-ILD.
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.
Pulmonary Arterial Hypertension (PAH)
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.
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.
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
sustained-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.
Remodulin is a registered trademark of
United Therapeutics Corporation.
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. Such forward-looking statements,