Full Press Release Details
Liquidia Corporation Reports Second Quarter
2025 Financial Results and Provides Corporate Update
MORRISVILLE, N.C., August 12,
2025 - Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with
rare cardiopulmonary diseases, today announced its financial results for the second quarter ended June 30, 2025. The company will
also host a webcast at 8:30 a.m. Eastern Time on August 12, 2025, to review financial performance and provide a corporate
Dr. Roger Jeffs, Liquidia's Chief
Executive Officer, said: "The second quarter was a defining period for Liquidia with the FDA approval and rapid commercial launch
of YUTREPIA (treprostinil) inhalation powder. More than 350 physicians across the country have already prescribed YUTREPIA to treat
patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), including
those new to prostacyclin treatment or transitioning from Tyvaso , Tyvaso DPI , and even from oral prostacyclins. In the 11
weeks since approval, we've recorded over 900 unique patient prescriptions leading to more than 550 patient starts. This initial
demand has exceeded my own high expectations.
The robust and increasing uptake reflects
a clear need for more flexible and better-tolerated prostacyclin therapies. We've already seen broad demand across both indications
from both cardiologists and pulmonologists. Notably, this early momentum has been achieved ahead of full payor adoption, highlighting
the potential for accelerating growth as we continue to expand market access during the third and fourth quarters.
we have continued to build differentiated clinical evidence of YUTREPIA's safety and efficacy
to treat PH-ILD through the ongoing, open-label ASCENT study, which fully enrolled last March (n=54). Interim analyses of eligible
patients at Week 8 and Week 16 reinforced YUTREPIA's tolerability profile at higher doses and showed sustained median improvements
in six-minute walk distance (6MWD) of 21.5 meters at Week 8 and 31.5 meters at Week 16. Importantly, patients titrated to a median dose
of 132.5mcg at Week 8 and 159mcg at Week 16 with no change in mean cough score. There were no discontinuations stemming from drug-related
adverse events, such as cough or throat irritation. More detailed clinical findings will be presented at medical conferences this in September and
With this strong early commercial execution,
compelling clinical evidence, and financial flexibility through our recent funding under our financing agreement (HCR Agreement) with
Healthcare Royalty (HCRx), we are well positioned to scale access to YUTREPIA, expand our clinical programs, and deliver durable
value for patients and shareholders."
Second Quarter and Recent Corporate Highlights
Second Quarter 2025 Financial Results
Cash and cash equivalents totaled $173.4 million as of June 30,
2025, compared to $176.5 million as of December 31, 2024.
Product revenue, net, was $6.5 million for
the three months ended June 30, 2025. Following receipt of full FDA approval for YUTREPIA on May 23, 2025, we began shipping
YUTREPIA to our customers in the United States in June 2025. We did not recognize any product revenue during the three months ended
Service revenue, net, was $2.3 million for
the three months ended June 30, 2025, compared to $3.7 million for the three months ended June 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 $1.4 million was primarily
due to the impact of unfavorable gross-to-net returns and managed care adjustments recorded in the current year.
Cost of product sales was $0.2 million for the three months ended
June 30, 2025 and related to sales of YUTREPIA. We did not record any cost of product sales
for the three months ended June 30, 2024.
Cost of service revenue was $1.3
million for the three months ended June 30, 2025, compared to $1.5 million for the three months ended June 30, 2024. Cost of
service revenue related to the Promotion Agreement as noted above.
Research and development expenses were $6.0 million for the three months
ended June 30, 2025, compared to $9.4 million for the three months ended June 30, 2024. The decrease of $3.4 million
or 36% was primarily due to a $2.7 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, a $1.0 million decrease in expenses related to our YUTREPIA
research and development activities, and a $0.4 million decrease in facilities and infrastructure expenses. These decreases were offset
by a $1.1 million increase in clinical expenses for our L606 program, primarily related to our planned global pivotal study for the treatment
Selling, general and administrative expenses were $38.8 million for
the three months ended June 30, 2025, compared to $19.9 million for the three months ended June 30, 2024. The increase
of $18.9 million or 95% was primarily due to a $8.8 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 $5.8 million
increase in legal fees related to our ongoing YUTREPIA-related litigation, a $2.3 million increase in commercial and consulting expenses
to support the commercialization of YUTREPIA, and a $1.3 million increase in facilities and infrastructure expenses.
Total other expense, net was $4.1 million for the three months ended
June 30, 2025, compared with $1.5 million for the three months ended June 30, 2024. The increase of $2.6 million was
primarily attributable to the higher borrowings under the HCR Agreement.
Net loss for the three months ended June 30, 2025, was $41.6
million or $0.49 per basic and diluted share, compared to a net loss of $28.7 million, or $0.38 per basic and diluted
share, for the three months ended June 30, 2024.
Liquidia will host a live webcast at 8:30 a.m. Eastern Time on
August 12, 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.
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
L606 is an investigational, sustained-release
formulation of treprostinil administered twice-daily with a next-generation nebulizer. The L606 suspension uses Pharmosa Biopharm's
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.
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 (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.
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