Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $3.1 million, an increase from $3.0 million in Q1 2024, primarily due to the promotion agreement despite lower sales volumes [12] - Research and development expenses decreased by 31% to $7.0 million from $10.1 million year-over-year, mainly due to a reduction in personnel expenses as the focus shifted towards commercialization preparations [13] - General and administrative expenses increased by 48% to $30.1 million from $20.2 million, driven by higher personnel costs and legal fees related to ongoing litigation [14] - The net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024 [14] Business Line Data and Key Metrics Changes - The company is preparing for the potential launch of Eutrebia, an inhaled dry powder formulation for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [6][7] - Cohort A of the ASCENT study is fully enrolled with over 50 patients, showing positive trends in dosing and tolerability [8] Market Data and Key Metrics Changes - The company anticipates a significant market opportunity in the inhaled treprostinil market, estimated at $2 billion, with additional opportunities in the oral prostacyclines market [65] - The expected payer mix for the prostacyclin market includes approximately 50% Medicare, 35% commercial, 10% Medicaid, and 5% other [71] Company Strategy and Development Direction - The company is focused on five strategic areas for the launch of Eutrebia: developing a best-in-class product profile, ensuring robust product availability, preparing a full suite of patient support services, establishing strong payer access, and maintaining a competitive share of voice in the market [7][10][11] - The company aims to transition patients from existing therapies to Eutrebia, emphasizing its differentiated product profile and ease of use [9][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Eutrebia, highlighting the favorable court ruling against United Therapeutics as a positive development [6][7] - The management team is optimistic about the potential for Eutrebia to become the first-choice treatment for patients with PAH and PHILD [16] Other Important Information - The company is preparing for data presentations at the American Thoracic Society's International Conference, showcasing interim results from the ASCENT study [8][51] - The company is also working on a global study for L606, a liposomal sustained release formulation of treprostinil, expected to initiate by the end of the year [29] Q&A Session Summary Question: Does United Therapeutics have any injunctive value left on the dismissed cross claim? - Management clarified that there are currently no active proceedings from United Therapeutics seeking to block FDA approval for Eutrebia, and the dismissal was without prejudice, meaning they could attempt to refile [20][22] Question: What are the patient baseline characteristics for the upcoming transition studies? - The transition study will focus on patients with PHILD currently on Tyvaso, evaluating safety and efficacy during the transition to Eutrebia [26][27] Question: What is the level of awareness of Eutrebia among targeted physicians? - Awareness is expected to increase significantly post-launch, with a comprehensive marketing strategy in place to ensure that healthcare providers are informed about Eutrebia's benefits [60][61] Question: What is the anticipated payer mix for PAH and PILD? - The expected payer mix includes approximately 50% Medicare, 35% commercial, 10% Medicaid, and 5% other [71] Question: Can you provide details on the four ninety-four patent infringement suit? - Management refrained from commenting on the specifics of the lawsuit, stating it is in the early stages [72]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $3.1 million, a slight increase from $3.0 million in Q1 2024, primarily due to the promotion agreement despite lower sales volumes [11] - Research and development expenses decreased by 31% to $7.0 million from $10.1 million year-over-year, attributed to a shift in focus towards commercialization preparations for Eutrebia [12] - General and administrative expenses increased by 48% to $30.1 million from $20.2 million, driven by higher personnel costs and legal fees related to ongoing litigation [13] - The net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024 [13] Business Line Data and Key Metrics Changes - The company is focusing on the potential launch of Eutrebia, an inhaled dry powder formulation for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [5][6] - Cohort A of the ASCENT study is fully enrolled with over 50 patients, showing positive trends in dosing and tolerability compared to previous studies [7] Market Data and Key Metrics Changes - The company anticipates a significant market opportunity in the inhaled treprostinil market, estimated at $2 billion, with additional opportunities in the oral prostacyclines market [66] - The expected payer mix for the prostacyclin market includes approximately 50% Medicare, 35% commercial, 10% Medicaid, and 5% other [73] Company Strategy and Development Direction - The company is preparing for the launch of Eutrebia by focusing on five strategic areas: product profile development, sales force readiness, patient support services, product availability, and payer access [6][10] - The company aims to position Eutrebia as a best-in-class therapeutic alternative for patients with PAH and PHILD [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Eutrebia, highlighting the favorable court ruling against United Therapeutics as a positive development [5][6] - The management team is optimistic about the differentiated product profile of Eutrebia and its potential to capture market share from existing therapies [10][66] Other Important Information - The ASCENT study data will be presented at the American Thoracic Society's International Conference, showcasing the product's tolerability and efficacy [7][56] - The company is actively preparing for potential legal challenges from competitors but remains confident in its position [22] Q&A Session Summary Question: Does United Therapeutics have any injunctive value left on the dismissed cross claim? - Management clarified that there are currently no active proceedings from United Therapeutics seeking to block Eutrebia's approval, and the dismissal was without prejudice, allowing for potential future actions [20][22] Question: What are the patient baseline characteristics for the upcoming transition studies? - The transition study will focus on patients with PHILD currently on Tyvaso, evaluating safety and efficacy during the transition to Eutrebia [26][27] Question: What is the company's strategy for converting patients to the dry powder formulation? - Management believes Eutrebia's formulation will provide a better patient experience, and they plan to target new patient starts initially before transitioning existing nebulized patients [33][36] Question: What will the prescriber support team look like? - The prescriber support team will leverage extensive experience in the field to enhance the prescribing experience and ensure patient access to Eutrebia [44][46] Question: What is the expected payer mix for PAH and PILD? - The anticipated payer mix includes about 50% Medicare, 35% commercial, and 10% Medicaid [73] Question: Can you provide details on the four ninety-four patent infringement suit? - Management refrained from commenting on the specifics of the lawsuit, stating it is in the early stages [75]

Liquidia Technologies, Inc. (LQDA) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.42. This compares to loss of $0.54 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -7.14%. A quarter ago, it was expected that this company would post a loss of $0.38 per share when it actually produced a loss of $0.46, delivering a surprise of -21.05%.Over the last four quarters, the company ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal quarter ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39724 LIQUIDIA CORPORATION Indicate by check mark whether the registrant (1) has filed all reports required to ...

Exhibit 99.1 Corporate Updates Awaiting FDA action on NDA for YUTREPIA (treprostinil) inhalation powder On March 28, 2025, the U.S. Food and Drug Administration (FDA) accepted Liquidia's New Drug Application (NDA) resubmission for YUTREPIA (treprostinil) inhalation powder to treat PAH and PH-ILD as a complete Class 1 response to the previous action letter issued on August 16, 2024, which granted tentative approval of YUTREPIA. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 202 ...

Core Viewpoint - Liquidia Corporation is focused on the potential commercialization of YUTREPIA, an inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), with an FDA decision expected by May 24, 2025 [2][3][8]. Corporate Updates - The FDA accepted Liquidia's New Drug Application (NDA) resubmission for YUTREPIA, setting a PDUFA goal date of May 24, 2025, coinciding with the expiration of regulatory exclusivity for Tyvaso DPI [3][8]. - A U.S. District Court dismissed a cross-claim from United Therapeutics challenging the NDA amendment for YUTREPIA, allowing Liquidia to proceed without legal hindrance [4][8]. - Liquidia completed enrollment of Cohort A in the ASCENT study, with over 50 patients, showing promising results in dosing and tolerability [5][8]. Financial Position - Liquidia entered into a sixth amendment with HealthCare Royalty, allowing for up to an additional $100 million in financing to support the development of YUTREPIA and other clinical trials [6][8]. - As of March 31, 2025, cash and cash equivalents were $169.8 million, a decrease from $176.5 million at the end of 2024 [7][8]. - Revenue for Q1 2025 was $3.1 million, a slight increase from $3.0 million in Q1 2024, primarily from a promotion agreement with Sandoz [9][8]. Expenses and Losses - Research and development expenses decreased by 31% to $7.0 million in Q1 2025, down from $10.1 million in Q1 2024, due to a shift in focus towards commercialization [11][8]. - General and administrative expenses rose by 48% to $30.1 million in Q1 2025, attributed to increased personnel costs and legal fees [12][8]. - The net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024 [14][8].

Core Insights - The article discusses potential investment opportunities in LQDA, indicating a possible long position may be initiated within the next 72 hours [1]. Group 1 - The analyst has no current stock, option, or similar derivative position in any of the companies mentioned [1]. - The article expresses the author's own opinions and is not receiving compensation from any company mentioned [1]. - There is an indication of a potential beneficial long position through stock or call options in LQDA [1].

Company Overview - Liquidia Technologies, Inc. (LQDA) shares increased by 13.2% to close at $15.83, with notable trading volume compared to typical sessions, following a 1.1% loss over the past four weeks [1][2] Recent Developments - The U.S. District Court for the District of Columbia dismissed a cross-claim by United Therapeutics challenging Liquidia's amendment to its new drug application for Yutrepia, which now includes treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2] Financial Expectations - Liquidia is expected to report a quarterly loss of $0.42 per share, reflecting a year-over-year increase of 22.2%, with revenues projected at $3.31 million, up 11.4% from the previous year [3] - The consensus EPS estimate for Liquidia has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Liquidia Technologies operates within the Zacks Medical - Biomedical and Genetics industry, where CRISPR Therapeutics AG (CRSP) also competes, having closed 1.4% higher at $38.25 and showing a 15.5% return over the past month [4]

Core Viewpoint - Liquidia Corporation has received a favorable ruling from the U.S. District Court, which dismissed United Therapeutics' cross-claim against its New Drug Application (NDA) for YUTREPIA, allowing the company to proceed with its plans for the drug's approval [1][2]. Group 1: Legal Developments - The U.S. District Court dismissed United Therapeutics' cross-claim regarding Liquidia's amendment to its NDA for YUTREPIA, determining that the claim was unripe and lacked standing [1][2]. - United Therapeutics retains the right to appeal the court's decision [2]. Group 2: Product Development and Approval Timeline - The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the YUTREPIA NDA on May 24, 2025, following the expiration of regulatory exclusivity on May 23, 2025 [3][6]. - Liquidia aims for YUTREPIA to become the preferred treatment for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2][4]. Group 3: Company Overview - Liquidia Corporation focuses on developing innovative therapies for rare cardiopulmonary diseases, with a particular emphasis on pulmonary hypertension [4]. - The company is also working on L606, a sustained-release formulation of treprostinil, and markets a generic version of Treprostinil Injection for PAH treatment [4].

Core Points - Liquidia Corporation will report its first quarter 2025 financial results on May 8, 2025, and will host a webcast at 8:30 a.m. Eastern Time to discuss these results and provide a corporate update [1][2] Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for patients with rare cardiopulmonary diseases [3] - The company's primary focus includes the development and commercialization of products for pulmonary hypertension, utilizing its proprietary PRINT Technology [3] - Liquidia's lead candidate is YUTREPIA™ (treprostinil) inhalation powder, aimed at treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [3] - The company is also developing L606, a sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [3]