Liquidia Corp(LQDA) - 2025 Q1 - Quarterly Results

Company Overview and Q1 2025 Highlights Liquidia Corporation reported Q1 2025 financial results, emphasizing YUTREPIA's regulatory progress, legal outcome, and financial strengthening Introduction and CEO Statement Liquidia Corporation reported its first quarter 2025 financial results, with CEO Dr. Roger Jeffs emphasizing the company's focus on preparing YUTREPIA for commercial availability pending FDA approval, believing it has the potential to be the prostacyclin of first choice for PAH and PH-ILD patients - Liquidia Corporation reported Q1 2025 financial results and provided a corporate update[2] - CEO Dr. Roger Jeffs highlighted the upcoming FDA PDUFA goal date for YUTREPIA NDA (May 24, 2025) and the company's readiness for commercial launch upon full approval[3] - YUTREPIA is believed to have the potential to be the prostacyclin of first choice for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)[3] Corporate Updates Liquidia provided several key corporate updates, including significant progress on YUTREPIA's regulatory pathway with the FDA, a favorable legal outcome against United Therapeutics, and a strengthened financial position through an amended financing agreement YUTREPIA Regulatory and Clinical Progress This section details YUTREPIA's regulatory progress, including FDA NDA resubmission, PDUFA goal date, and positive interim data from the ASCENT study - The FDA accepted Liquidia's New Drug Application (NDA) resubmission for YUTREPIA (treprostinil) inhalation powder for PAH and PH-ILD as a complete Class 1 response[4] - The FDA has set a PDUFA goal date of May 24, 2025, for YUTREPIA, coinciding with the day after regulatory exclusivity expires for Tyvaso DPI®[4] - Liquidia completed enrollment of Cohort A of the open-label ASCENT study for YUTREPIA in PH-ILD patients, with over 50 patients enrolled[6] - Interim data from the first 20 patients in ASCENT Cohort A showed tolerability consistent with the INSPIRE study and positive trends on exploratory efficacy measures, including 6-minute walk distance, with patients titrating to doses three-times higher than nebulized Tyvaso's target dose[6] Legal Developments The U.S. District Court dismissed United Therapeutics' cross-claim challenging Liquidia's YUTREPIA NDA amendment for the PH-ILD indication - The U.S. District Court for the District of Columbia dismissed, without prejudice, a cross-claim filed by United Therapeutics (UTHR) challenging Liquidia's amendment to its YUTREPIA NDA to add the PH-ILD indication[5] - The District Court ruled that UTHR's claim was unripe and that UTHR failed to plausibly allege standing, though UTHR retains the right to appeal[5] Financial Strengthening Liquidia strengthened its financial position by amending the HCR agreement to secure up to an additional $100 million in financing - Liquidia entered into a sixth amendment to its agreement with HealthCare Royalty (HCR Agreement) to provide for up to an additional $100 million of financing in three tranches[8] - The proceeds are intended to fund ongoing commercial development of YUTREPIA, continued development of YUTREPIA in other clinical trials (including pediatric and further PAH/PH-ILD trials), clinical development of L606, and general corporate purposes[8] - Key updates include awaiting FDA action on YUTREPIA™ NDA with a PDUFA goal date of May 24, 2025[7] - The District Court dismissed a cross-claim filed by United Therapeutics challenging the PH-ILD amendment to the YUTREPIA NDA[7] - Cohort A of the ASCENT study in patients with PH-ILD has been fully enrolled[7] - Liquidia further strengthened its financial position by accessing up to an additional $100 million from an existing financing agreement with HealthCare Royalty[7][8] First Quarter 2025 Financial Results Liquidia's Q1 2025 financial results are presented, detailing balance sheet highlights and income statement analysis Balance Sheet Highlights As of March 31, 2025, Liquidia's cash and cash equivalents decreased slightly from the end of 2024, while total liabilities increased and total stockholders' equity decreased | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------ | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $169,758 | $176,479 | | Total assets | $227,429 | $230,313 | | Total liabilities | $177,716 | $150,935 | | Accumulated deficit | $(595,756) | $(557,389) | | Total stockholders' equity| $49,713 | $79,378 | Income Statement Analysis For Q1 2025, Liquidia reported a slight increase in revenue, a 31% decrease in R&D expenses due to a shift towards commercialization, and a 48% increase in G&A expenses driven by higher headcount and commercialization preparation. The net loss widened to $38.4 million | Metric (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Revenue | $3,120 | $2,972 | +$148 (+5.0%) | | Cost of revenue | $1,517 | $1,467 | +$50 (+3.4%) | | Research and development | $6,966 | $10,057 | -$3,091 (-30.7%) | | General and administrative | $30,062 | $20,249 | +$9,813 (+48.5%) | | Total costs and expenses | $38,545 | $31,773 | +$6,772 (+21.3%) | | Loss from operations | $(35,425) | $(28,801) | -$(6,624) (-23.0%) | | Total other expense, net | $(2,942) | $(1,282) | -$(1,660) (-129.5%) | | Net loss and comprehensive loss | $(38,367) | $(30,083) | -$(8,284) (-27.5%) | | Net loss per common share, basic and diluted | $(0.45) | $(0.40) | -$(0.05) (-12.5%) | - The $0.1 million increase in revenue was primarily due to the impact of unfavorable gross-to-net returns adjustments recorded in the prior year offset by lower sales volumes in the current year, related to the promotion agreement with Sandoz, Inc. for Treprostinil Injection[10] - The decrease in R&D expenses was primarily due to a $3.6 million decrease in personnel expenses as activities shifted from R&D to preparation for YUTREPIA's potential commercialization, partially offset by a $1.7 million increase in clinical expenses for the L606 program[12] - The increase in G&A expenses was primarily due to an $8.1 million increase in personnel expenses (higher headcount and shift from R&D to commercialization prep), a $0.6 million increase in legal fees for YUTREPIA-related litigation, and a $0.6 million increase in facilities and infrastructure expenses[13] - The increase in total other expense, net, was primarily driven by a $1.5 million increase in interest expense attributable to higher borrowings under the HCR Agreement[14] Product Portfolio and Disease Information Liquidia's product portfolio, including YUTREPIA and L606, is outlined alongside overviews of PAH and PH-ILD Key Product Candidates Liquidia's product pipeline includes YUTREPIA, an investigational inhaled dry-powder treprostinil with tentative FDA approval, L606, an investigational sustained-release liposomal treprostinil, and the commercially available generic Treprostinil Injection YUTREPIA™ (treprostinil) Inhalation Powder YUTREPIA is an investigational, inhaled dry-powder treprostinil formulation with tentative FDA approval, designed using PRINT® technology for enhanced lung deposition - YUTREPIA is an investigational, inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device[16] - It received tentative FDA approval in August 2024 for PAH and PH-ILD indications[16] - YUTREPIA was designed using Liquidia's PRINT® technology for precise and uniform drug particles, engineered for enhanced lung deposition[16] - Clinical studies include INSPIRE (Phase 3 for PAH) and ASCENT (Open-Label for PH-ILD safety and tolerability)[16] L606 (liposomal treprostinil) Inhalation Suspension L606 is an investigational, sustained-release liposomal treprostinil formulation administered twice-daily, currently in an open-label study for PAH and PH-ILD - L606 is an investigational, sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer[17] - It uses Pharmosa Biopharm's proprietary liposomal formulation to encapsulate treprostinil for slow, controlled release and extended drug exposure in the lung[17] - L606 is currently being evaluated in an open-label study in the US for PAH and PH-ILD, with a planned global pivotal placebo-controlled efficacy study for PH-ILD[17] Treprostinil Injection (Generic) Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration, promoted in partnership with Sandoz - Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration[18] - It contains the same active ingredient, strengths, dosage form, and inactive ingredients as Remodulin (treprostinil) and is offered at a lower price[18] - Liquidia PAH promotes its use in the US in partnership with Sandoz, who holds the Abbreviated New Drug Application (ANDA) with the FDA[18] Disease Overviews This section provides an overview of Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD), detailing their characteristics, prevalence, and current treatment landscape Pulmonary Arterial Hypertension (PAH) PAH is a rare, chronic, progressive disease affecting pulmonary arteries, with an estimated 45,000 patients in the US, lacking a cure but managed with symptom-alleviating treatments - PAH is a rare, chronic, progressive disease caused by hardening and narrowing of pulmonary arteries, leading to right heart failure and potentially death[19] - An estimated 45,000 patients are diagnosed and treated in the United States[19] - There is no cure for PAH; existing treatments aim to alleviate symptoms, improve functional class, delay disease progression, and enhance quality of life[19] Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) PH-ILD encompasses diverse pulmonary diseases, significantly impacting survival, with an estimated prevalence exceeding 60,000 patients in the US - PH-ILD encompasses a diverse collection of up to 150 different pulmonary diseases, including interstitial pulmonary fibrosis and chronic hypersensitivity pneumonitis[20] - Any level of PH in ILD patients is associated with poor 3-year survival[20] - Current estimates place PH-ILD prevalence in the United States at greater than 60,000 patients, though actual prevalence may be higher due to underdiagnosis and historical lack of approved treatments[20] Additional Information Liquidia Corporation details, forward-looking statements, financial revision, and contact information are provided About Liquidia Corporation Liquidia Corporation is a biopharmaceutical company focused on developing and commercializing innovative therapies for rare cardiopulmonary diseases, leveraging its proprietary PRINT Technology for products like YUTREPIA and L606, and marketing generic Treprostinil Injection - Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease[21] - The company's focus includes developing and commercializing products in pulmonary hypertension and other applications of its proprietary PRINT Technology[21] - Its lead candidate is YUTREPIA™ (treprostinil) inhalation powder, and it is also developing L606 and markets generic Treprostinil Injection[21] Cautionary Statements Regarding Forward-Looking Statements This section provides a standard disclaimer regarding forward-looking statements, highlighting that actual results may differ materially due to significant risks and uncertainties inherent in the competitive and rapidly changing biopharmaceutical industry, and the company undertakes no duty to update these statements - The press release includes forward-looking statements regarding future results, financial position, strategic initiatives, business strategy, and operational objectives[23] - These statements involve significant risks and uncertainties, and actual results could differ materially from those expressed or implied[23] - The company operates in a competitive and rapidly changing environment with inherent industry risks, and new risks may emerge[23] - Liquidia undertakes no duty to update its goals or any forward-looking statements[23] Financial Statement Revision Liquidia voluntarily revised its previously issued 2024 annual consolidated financial statements to correct immaterial errors related to the accounting treatment of the fourth and fifth amendments to the HCR Agreement, resulting in adjustments to interest expense, long-term debt, and accumulated deficit - Liquidia identified immaterial errors in its accounting treatment of the fourth and fifth amendments to the HCR Agreement during Q1 2025[24] - The company voluntarily revised its previously issued 2024 annual consolidated financial statements to correct these errors[24] - The revision eliminated a loss on extinguishment and recorded an adjustment to interest expense, with corresponding adjustments to long-term debt and accumulated deficit accounts[24] Contact Information Contact details for investor relations and media inquiries are provided, including names, titles, and contact numbers for Jason Adair (Chief Business Officer) and Patrick Wallace (Director, Corporate Communications) - Investors can contact Jason Adair, Chief Business Officer, at 919.328.4350 or Jason.adair@liquidia.com[25] - Media can contact Patrick Wallace, Director, Corporate Communications, at 919.328.4383 or patrick.wallace@liquidia.com[25] Condensed Consolidated Financial Statements Liquidia Corporation's unaudited condensed consolidated financial statements, including balance sheet and income statement data, are presented Select Condensed Consolidated Balance Sheet Data This section presents the unaudited condensed consolidated balance sheet data for Liquidia Corporation as of March 31, 2025, and December 31, 2024, showing key financial positions | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------ | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $169,758 | $176,479 | | Total assets | $227,429 | $230,313 | | Total liabilities | $177,716 | $150,935 | | Accumulated deficit | $(595,756) | $(557,389) | | Total stockholders' equity| $49,713 | $79,378 | Condensed Consolidated Statements of Operations and Comprehensive Loss This section provides the unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025, and March 31, 2024, detailing revenue, expenses, and net loss | Metric (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Revenue | $3,120 | $2,972 | | Costs and expenses: | | | | Cost of revenue | $1,517 | $1,467 | | Research and development | $6,966 | $10,057 | | General and administrative | $30,062 | $20,249 | | Total costs and expenses | $38,545 | $31,773 | | Loss from operations | $(35,425) | $(28,801) | | Other income (expense): | | | | Interest income | $1,728 | $1,880 | | Interest expense | $(4,670) | $(3,162) |\ | Total other expense, net | $(2,942) | $(1,282) | | Net loss and comprehensive loss | $(38,367) | $(30,083) | | Net loss per common share, basic and diluted | $(0.45) | $(0.40) | | Weighted average common shares outstanding, basic and diluted | 85,172,696 | 75,393,907 |