Liquidia Corp(LQDA) - 2025 Q2 - Quarterly Results

Corporate Overview and Highlights The company achieved significant milestones in Q2 2025, including FDA approval and successful commercial launch of YUTREPIA, securing financing, and positive clinical data, positioning for growth CEO Statement & Key Achievements The CEO highlighted Q2 as a defining period, marked by successful FDA approval and rapid commercial launch of YUTREPIA™ for PAH and PH-ILD, with initial market uptake exceeding expectations and positive interim data from the ASCENT study reinforcing its profile - YUTREPIA™ achieved over 900 unique patient prescriptions and 550 patient starts within the first 11 weeks of its commercial launch[3][6] - The initial launch success was achieved with broad demand from both cardiologists and pulmonologists, even ahead of securing full payor coverage, indicating strong underlying clinical demand[4] - Interim data from the ASCENT study in PH-ILD patients showed a median improvement in six-minute walk distance (6MWD) of 31.5 meters at Week 16, with a favorable tolerability profile and no discontinuations due to drug-related adverse events like cough[5][6] - The company is well-capitalized to scale YUTREPIA access and expand clinical programs following recent funding under its financing agreement with Healthcare Royalty (HCRx)[6] Second Quarter and Recent Corporate Highlights This section details key corporate events in Q2 2025, including the FDA approval of YUTREPIA, its commercial launch, securing $50 million in financing, leasing a new 70,000 sq ft manufacturing facility, and positive interim data from the ASCENT trial - On May 23, 2025, the FDA approved YUTREPIA™ for treating PAH and PH-ILD, with the commercial launch and first shipments initiated in the first week of June 2025[10] - The company secured $50.0 million on June 23, 2025, under its financing agreement with HCRx following the first commercial sale of YUTREPIA[10] - To support future growth, Liquidia signed a lease on June 16, 2025, for an additional 70,000 square feet of manufacturing space, targeted for occupancy in 2026[10] - The ASCENT open-label study was fully enrolled with 54 PH-ILD patients, and interim data showed good tolerability, with only 2 of 26 patients reporting a moderate cough and no change in mean cough scores through Week 16[10] Q2 2025 Financial Performance Liquidia's Q2 2025 financial performance reflects initial YUTREPIA sales, increased net loss due to commercialization expenses, and a strong cash position Financial Results Summary For Q2 2025, Liquidia reported total revenue of $8.8 million, primarily from YUTREPIA product sales, with a net loss increasing to $41.6 million due to a 95% rise in SG&A expenses for commercialization and a 36% decrease in R&D spending Q2 2025 vs Q2 2024 Financial Performance (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Product Revenue, net | $6.5 | $0.0 | +$6.5 | | Service Revenue, net | $2.3 | $3.7 | -$1.4 | | Total Revenue | $8.8 | $3.7 | +$5.1 | | R&D Expenses | $6.0 | $9.4 | -36% | | SG&A Expenses | $38.8 | $19.9 | +95% | | Net Loss | ($41.6) | ($28.7) | +$12.9 | | Net Loss Per Share | ($0.49) | ($0.38) | +$0.11 | - Cash and cash equivalents stood at $173.4 million as of June 30, 2025, a slight decrease from $176.5 million at the end of 2024[8] - The 95% increase in SG&A expenses was primarily driven by higher headcount for commercialization activities ($8.8 million), increased legal fees for ongoing litigation ($5.8 million), and commercial/consulting expenses ($2.3 million)[13] - The 36% decrease in R&D expenses was mainly due to a shift in personnel from R&D to commercial activities and lower expenses for YUTREPIA development, partially offset by increased clinical expenses for the L606 program[12] Condensed Financial Statements The unaudited condensed financial statements provide a detailed view of Liquidia's financial position and operational results, with the balance sheet showing total assets of $257.4 million and total liabilities of $242.2 million as of June 30, 2025, and a net loss of $41.6 million for the quarter Condensed Consolidated Balance Sheet Data (unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $173,422 | $176,479 | | Total assets | $257,410 | $230,313 | | Total liabilities | $242,221 | $150,935 | | Total stockholders' equity | $15,189 | $79,378 | Condensed Consolidated Statements of Operations (unaudited, in thousands) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenue | $8,837 | $3,659 | | Total costs and expenses | $46,342 | $30,856 | | Loss from operations | ($37,505) | ($27,197) | | Total other expense, net | ($4,074) | ($1,471) | | Net loss and comprehensive loss | ($41,579) | ($28,668) | Product Portfolio and Pipeline Liquidia's portfolio includes the recently approved YUTREPIA, the investigational L606, and a generic treprostinil injection, leveraging proprietary technology for pulmonary hypertension treatments YUTREPIA™ (treprostinil) Inhalation Powder YUTREPIA is an FDA-approved inhaled dry-powder formulation of treprostinil for treating PAH and PH-ILD, developed using Liquidia's proprietary PRINT® technology for enhanced lung deposition via a convenient, low-effort device - Indicated for the treatment of PAH and PH-ILD to improve exercise ability[16] - Utilizes PRINT® technology to create precise and uniform drug particles for enhanced delivery to the lung[16] L606 (liposomal treprostinil) Inhalation Suspension L606 is an investigational, sustained-release liposomal formulation of treprostinil administered twice daily with a next-generation nebulizer, currently being evaluated in an open-label study for PAH and PH-ILD, with a global pivotal study planned for PH-ILD treatment - L606 is an investigational, sustained-release formulation of treprostinil administered twice-daily[17] - A global pivotal placebo-controlled efficacy study is planned for the treatment of PH-ILD[17] Treprostinil Injection This is a first-to-file, fully substitutable generic treprostinil for parenteral administration, equivalent to Remodulin, marketed in the United States through a commercial partnership with Sandoz - A fully substitutable generic treprostinil for parenteral administration[18] - Marketed in the U.S. in partnership with commercial partner Sandoz[18] Other Information This section addresses forward-looking statements, highlighting litigation risks and the revision of prior financial statements due to immaterial accounting errors Forward-Looking Statements This section contains standard cautionary language advising investors that the press release includes forward-looking statements involving significant risks and uncertainties, including ongoing patent litigation with United Therapeutics, which could materially affect actual results - The press release contains forward-looking statements with significant risks and uncertainties, and actual results could differ materially[23] - A key risk highlighted is the ongoing litigation with United Therapeutics, which is seeking an injunction that could block the continued sale of YUTREPIA[23] Financial Statement Revision The company disclosed that during Q1 2025, it identified and corrected immaterial errors in its accounting treatment of amendments to the HCR Agreement, leading to the voluntary revision of previously issued 2024 annual and interim financial statements - Immaterial errors were identified in the accounting treatment for the fourth and fifth amendments to the HCR Agreement[24] - Previously issued 2024 financial statements have been revised to correct the errors, with the financial data presented in this press release reflecting these revisions[24]