Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
Indicate by check mark whether the
registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
On March 5, 2026, Liquidia Corporation, a
Delaware corporation, issued a press release announcing its financial results for the full year ended December 31, 2025, and also
provided a corporate update. A copy of the press release is furnished herewith as Exhibit 99.1.*
* The information in Item 2.02 of this Form 8-K shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Exhibit 99.1
Liquidia Corporation Reports Fourth Quarter
and Full Year 2025 Financial Results and Provides Business Update
| · | Achieved
YUTREPIA® net product sales of $148.3 million for the full year 2025 with $90.1 million
in the fourth quarter |
| · | More than 3,600 unique prescriptions received and 2,900 patients treated to date since launch in June 2025 |
| · | Ended 2025 with $190.7 million in cash and cash equivalents, an increase of $33 million from the third quarter |
| · | Recorded second consecutive quarter of profitability |
MORRISVILLE,
N.C., March 5, 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 reported financial results
for the full year ended December 31, 2025. The company will also host a webcast at 8:30 a.m. ET on March 5, 2026, to discuss
its financial results and provide a corporate update.
Dr. Roger Jeffs, Liquidia’s Chief
Executive Officer, said: “As we close 2025, we are encouraged by how quickly YUTREPIA® has taken hold in clinical practice,
placing it among one of the top specialty drug launches over the past five years across all therapeutic categories. Adoption continues
to broaden across PAH and PH-ILD, with increasing depth in treatment centers and more experience transitioning appropriate patients from
oral, inhaled and systemic prostacyclin therapies.
Having increased profitability in our second
full quarter after launch, we will build on this foundation in 2026 from a position of financial strength. We plan to deepen prescriber
adoption, grow our sales force, expand YUTREPIA’s clinical evidence through multiple new studies, and advance L606 into pivotal
trials, all of which will be funded from operations. 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 serious and progressive cardiopulmonary diseases.”
YUTREPIA® Commercial Launch Highlights
(as of February 28, 2026)
| · | Received more than 3,600 unique patient prescriptions since launch |
| · | Started more than 2,900 patients on treatment since launch |
| · | Prescription-to-start conversion remained strong at or above the 85% level reported in the third quarter of 2025 |
| · | Increased total number of prescribers to approximately 860, more than half of whom have prescribed YUTREPIA to at least 2 patients
and 25% have referred 5 or more patients |
Fourth Quarter and Full Year 2025 Financial Results
YUTREPIA sales led to the company’s second consecutive quarter
of profitability with net income of $14.6 million and positive non-GAAP adjusted EBITDA of $27.3 million in fourth quarter of
2025.
Cash and
cash equivalents totaled $190.7 million as of December 31, 2025, compared to $176.5 million as of December 31,
2024.
Product
sales, net, were $148.3 million in the year ended December 31, 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 revenue
from product sales during 2024.
Service
revenue, net, was $10.0 million for the year ended December 31, 2025, compared to $14.0 million for the year ended December 31,
2024. Service revenue, net was 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. The decrease of $4.0 million was primarily due to lower sales
volumes in the current year.
Cost of
product sales was $8.8 million for the year ended December 31, 2025. Cost of product sales is related to sales of YUTREPIA.
We did not record any cost of product sales during 2024.
Cost of
service revenue was $4.4 million for the year ended December 31, 2025, compared to $5.9 million for the year ended December 31,
2024. The decrease from 2024 to 2025 reflects a lower 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 $39.3 million for the year ended December 31, 2025, compared to $47.8 million for the year
ended December 31, 2024, a decrease of $8.5 million or 18%. The decrease was primarily due to an $8.8 million decrease in personnel
expenses, a $2.2 million decrease in stock-based compensation, and a $3.0 million decrease in facilities and infrastructure expenses resulting
from a shift from activities related to research and development to the commercialization of YUTREPIA in addition to a $1.7 million decrease
in expenses related to our YUTREPIA research and development activities. These decreases were offset by a $9.0 million increase in clinical
expenses for our L606 program.
Selling,
general and administrative expenses were $157.2 million for the year ended December 31, 2025, compared to $81.6 million
for the year ended December 31, 2024, an increase of $75.6 million or 93%. The increase was primarily due to a $33.7 million increase
in personnel expenses and a $12.7 million increase in stock-based compensation driven by higher headcount, a $16.1 million increase in
commercial and consulting expenses to support the commercialization of YUTREPIA, a $5.3 million increase in legal fees related to our
ongoing YUTREPIA-related litigation, and a $3.7 million increase in facilities and infrastructure expenses.
Total other
expenses, net was $17.5 million for the year ended December 31, 2025, compared to $7.0 million for the year ended December 31,
2024. The increase of $10.5 million was primarily attributable to the higher borrowings under our revenue interest financing agreement
with HealthCare Royalty Partners IV, L.P.
Net loss
for the year ended December 31, 2025, was $68.9 million, or $0.80 per basic and diluted share, as compared to a net loss of $128.3
million, or $1.63 per basic and diluted share, for the year ended December 31, 2024.
Webcast Information
Liquidia
will host a live webcast at 8:30 a.m. Eastern Time on March 5, 2026, to discuss the year end 2025 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 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 (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
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 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.
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 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 or both of PAH and PH-ILD. 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 SEC, as well as a number of uncertainties and assumptions. Moreover, we operate
in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is
not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which
any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements
we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and
actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this
press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update
our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
Use of Non-GAAP Financial Information
This press release and the accompanying tables
include U.S. Generally Accepted Accounting Principles (GAAP) and non-GAAP financial measures. For a description of such non-GAAP financial
measures, including the reasons for using such measures, and reconciliations of such non-GAAP financial measures to the most directly
comparable financial measures prepared in accordance with GAAP, please see the section titled “About Non-GAAP Financial Information”
below.
Contact Information
Investors:
Jason Adair
Chief Business Officer
919.328.4350
Jason.adair@liquidia.com
Media:
media@liquidia.com
Liquidia Corporation
Select Consolidated Balance Sheet Data
(in thousands)
| | |
December 31, | | |
December 31, | |
| | |
2025 | | |
2024 | |
| Cash and cash equivalents | |
$ | 190,680 | | |
$ | 176,479 | |
| Total assets | |
$ | 327,934 | | |
$ | 230,313 | |
| Total liabilities | |
$ | 283,186 | | |
$ | 150,935 | |
| Accumulated deficit | |
$ | (626,313 | ) | |
$ | (557,389 | ) |
| Total stockholders’ equity | |
$ | 44,748 | | |
$ | 79,378 | |
Liquidia
Corporation
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
| | |
Three Months Ended
December 31, | | |
Twelve Months Ended
December 31, | |
| | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| | |
(unaudited) | | |
| | |
| |
| Revenues: | |
| | |
| | |
| | |
| |
| Product sales, net | |
$ | 90,102 | | |
| - | | |
$ | 148,288 | | |
| — | |
| Service revenue, net | |
| 1,919 | | |
| 2,917 | | |
| 10,032 | | |
| 13,996 | |
| Total revenue | |
| 92,021 | | |
| 2,917 | | |
| 158,320 | | |
| 13,996 | |
| Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
| Cost of product sales | |
| 6,324 | | |
| - | | |
| 8,824 | | |
| — | |
| Cost of service revenue | |
| 731 | | |
| 1,354 | | |
| 4,418 | | |
| 5,879 | |
| Research and development | |
| 16,943 | | |
| 16,475 | | |
| 39,276 | | |
| 47,842 | |
| Selling, general and administrative | |
| 48,236 | | |
| 21,195 | | |
| 157,178 | | |
| 81,569 | |
| Total costs and expenses | |
| 72,234 | | |
| 39,024 | | |
| 209,696 | | |
| 135,290 | |
| Income (loss) from operations | |
| 19,787 | | |
| (36,107 | ) | |
| (51,376 | ) | |
| (121,294 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Interest income | |
| 1,667 | | |
| 2,104 | | |
| 6,624 | | |
| 7,654 | |
| Interest expense | |
| (6,899 | ) | |
| (4,507 | ) | |
| (24,172 | ) | |
| (14,651 | ) |
| Total other expense, net | |
| (5,232 | ) | |
| (2,403 | ) | |
| (17,548 | ) | |
| (6,997 | ) |
| Net income (loss) and comprehensive income (loss) | |
| 14,555 | | |
| (38,510 | ) | |
$ | (68,924 | ) | |
$ | (128,291 | ) |
| Net income (loss) per common share, basic | |
| 0.17 | | |
| (0.45 | ) | |
$ | (0.80 | ) | |
$ | (1.63 | ) |
| Net income (loss) per common share, diluted | |
| 0.15 | | |
| (0.45 | ) | |
| (0.80 | ) | |
| (1.63 | ) |
| Weighted average common shares outstanding, basic | |
| 87,105,618 | | |
| 84,687,791 | | |
| 86,059,101 | | |
| 78,707,503 | |
| Weighted average common shares outstanding, diluted | |
| 100,051,780 | | |
| 84,687,791 | | |
| 86,059,101 | | |
| 78,707,503 | |
About Non-GAAP Financial Information
To supplement
our financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), this press release includes certain
non-GAAP financial measures, such as Adjusted EBITDA. We believe the use of such non-GAAP financial measures provides investors with additional
insight into our operational performance. While we compute non-GAAP financial measures using a consistent method from quarter to
quarter and year to year, we may consider whether other significant items that arise in the future should be excluded from our non-GAAP
financial measures.
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 GAAP, please see the table
titled “Reconciliation of Non-GAAP Financial Information” below.
Liquidia Corporation
Reconciliation
of Non-GAAP Financial Information
Reconciliation of Net Loss to Adjusted EBITDA
(unaudited)
(in thousands)
| | |
Three Months Ended | |
| | |
December 31, | |
| | |
2025 | |
| Net income | |
$ | 14,555 | |
| Interest expense, net | |
| 5,232 | |
| Income tax expense | |
| - | |
| Depreciation and amortization | |
| 321 | |
| EBITDA | |
$ | 20,108 | |
| Stock-based compensation | |
| 7,206 | |
| Adjusted EBITDA | |
$ | 27,314 | |
