Access to a webcast of the presentation will be available on the "Investors" page of Liquidia's website at https://liquidia.com/investors/events-and-presentations. An archived, recorded version of the presentation will be available on Liquidia's website for at least 30 days following the event. About Liquidia Corporation Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company's current focus spans the development and com ...

MORRISVILLE, N.C., April 01, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that the company will provide an overview of the company's business at a fireside chat at the 24 Annual Needham Virtual Healthcare Conference on Tuesday, April 8, 2025, beginning at 8:45 a.m. ET. Contact Information Investors: Jason Adair Chief Business Officer 919.328.4350 jason.adair@liquidia.c ...

MORRISVILLE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ:LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA confirmed t ...

- Data from the ASCENT study of LIQ861 (YUTREPIA™) in PH-ILD patients highlights safety, tolerability, exploratory changes in six-minute walk distance, cardiac effort and quality of life - Case study highlights the long-term safety and tolerability of LIQ861 (YUTREPIA) in a PAH patient transitioning from parenteral treprostinil in INSPIRE study MORRISVILLE, N.C., March 27, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients w ...

Liquidia Corporation (NASDAQ:LQDA) Q4 2024 Earnings Conference Call March 19, 2025 8:30 AM ET Company Participants Jason Adair - Chief Business Officer Roger Jeffs - CEO Michael Kaseta - COO and CFO Rajeev Saggar - Chief Medical Officer Scott Moomaw - Chief Commercial Officer Rusty Schundler - General Counsel Conference Call Participants Julian Harrison - BTIG Serge Belanger - Needham Ryan Deschner - Raymond James Greg Harrison - Scotiabank Cory Jubinville - LifeSci Capital Operator Good morning. And welcom ...

Group 1 - Liquidia Technologies, Inc. reported a quarterly loss of $0.46 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.38, and compared to a loss of $0.42 per share a year ago, indicating an earnings surprise of -21.05% [1] - The company posted revenues of $2.92 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 43.11%, and this represents a decline from year-ago revenues of $4.53 million [2] - Over the last four quarters, Liquidia Technologies has not surpassed consensus EPS estimates and has topped consensus revenue estimates only once [2] Group 2 - Liquidia Technologies shares have increased by approximately 25.3% since the beginning of the year, contrasting with a decline of -4.5% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.34 on revenues of $4.14 million, and for the current fiscal year, it is -$1.14 on revenues of $47.04 million [7] - The Medical - Biomedical and Genetics industry, to which Liquidia Technologies belongs, is currently ranked in the top 30% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Performance - The total reported net revenue of branded therapies targeting the prostacyclin pathway for PAH and PH-ILD in the U.S. was $4.1 billion in 2024[37]. - United Therapeutics' treprostinil-based products generated U.S. net revenue of $2.5 billion in 2024, with the Tyvaso franchise contributing $1.6 billion[37]. - Branded Remodulin generated U.S. revenue of approximately $464 million in 2024, down from $415 million in 2023, indicating a year-over-year decline of about 10.6%[51]. - The Tyvaso franchise's annual sales increased from $400 million in 2019 to $1.6 billion in 2024, correlating with the expansion into the PH-ILD indication[37]. Product Development and Approval - YUTREPIA received tentative FDA approval for both PAH and PH-ILD on August 16, 2024, with final approval delayed until May 23, 2025, due to regulatory exclusivity for Tyvaso DPI[25][44]. - The NDA for YUTREPIA was submitted in January 2020, and the FDA conducted pre-approval inspections in 2021[44]. - The ongoing open-label study for L606, a liposomal formulation of treprostinil, is evaluating its efficacy for PAH and PH-ILD[27]. - The upcoming global placebo-controlled efficacy study for L606 will include approximately 340 patients across more than 100 sites in at least 20 countries[68]. - The company plans to commercialize YUTREPIA in the U.S. market for PAH and PH-ILD, leveraging existing relationships with healthcare providers[74]. Technology and Innovation - YUTREPIA's formulation utilizes PRINT technology to enhance aerosolization and lung deposition, allowing for a low-effort delivery device[40]. - The proprietary PRINT technology allows for the engineering of drug particles that enhance pharmacological benefits, including prolonged duration of drug release and reduced adverse side effects[69]. - The L606 inhalation system is designed for rapid delivery using breath-actuated smart technology, allowing for a dose in less than 2 minutes[62]. - The L606 formulation demonstrated comparable bioavailability to nebulized Tyvaso, with a single dose of L606 (51 mcg) resulting in a significantly reduced peak plasma concentration approximately 7.3-fold lower than Tyvaso (54 mcg)[65]. - L606 is expected to reduce dosing frequency to twice daily, with extended plasma concentrations up to 12 hours after a single dose[66]. Regulatory Environment - The regulatory approval process for drug candidates in the United States requires substantial time and financial resources, with no guarantee of timely approvals[135]. - The FDA's Investigational New Drug application (IND) must be submitted before human clinical studies can begin, and it automatically becomes effective 30 days after receipt unless concerns are raised[137]. - Clinical studies are conducted in three phases: Phase 1 focuses on safety and dosage, Phase 2 evaluates efficacy and safety in a limited population, and Phase 3 assesses overall risk/benefit in a larger patient population[145]. - The submission of a New Drug Application (NDA) is subject to a substantial application user fee, with waivers available under certain conditions[148]. - The NDA review process includes an in-depth substantive review to determine safety and effectiveness, which may involve inspections of manufacturing facilities[153]. Competitive Landscape - The pharmaceutical industry is highly competitive, with major competitors having greater financial resources and faster marketing approval processes[110]. - Liquidia's product candidates, YUTREPIA and L606, will compete in the PAH and PH-ILD markets against existing therapies and new entrants[112]. - The company is pursuing both composition-of-matter patents and method-of-use patents for its product candidates[105]. Partnerships and Agreements - A license agreement with Pharmosa was established in June 2023, granting exclusive rights in North America for L606, with an upfront fee of $10 million and potential milestone payments of up to $37.75 million for clinical development[82][84]. - The company has a Promotion Agreement with Sandoz for Treprostinil Injection, which includes a profit-sharing structure where Liquidia PAH receives 50% of net profits up to $500 million and 75% for profits exceeding that amount[90]. - The company has entered into a Pump Development Agreement with Sandoz and Mainbridge for a new pump for subcutaneous administration of treprostinil, with shared development costs[89]. Compliance and Regulatory Risks - Compliance with healthcare laws and regulations may constrain the company's business and financial arrangements[216]. - The company faces risks related to government regulation, including anti-kickback and false claims laws, which may impact operations[217]. - The FDA may withdraw product approval if regulatory compliance is not maintained or if new safety issues arise post-marketing[194]. Market Dynamics and Pricing - Third-party payors significantly influence the coverage and reimbursement status of approved products, impacting commercialization[208]. - The U.S. government is increasingly interested in implementing cost containment programs, including price controls and restrictions on reimbursement[211]. - The Inflation Reduction Act of 2022 imposes a new corporate alternative minimum tax on corporations with average annual financial statement income exceeding $1 billion over a three-year period[214]. - Increased emphasis on managed care and cost containment measures in the U.S. is expected to continue, putting pressure on pharmaceutical pricing and coverage[215].

Financial Performance - Liquidia Corporation reported a net loss of $130.4 million or $1.66 per share for the year ended December 31, 2024, compared to a net loss of $78.5 million or $1.21 per share for the previous year, reflecting an increase in losses of 66.3%[14] - Revenue for the year was $14.0 million, down from $17.5 million in 2023, a decrease of 20% primarily due to lower sales quantities of Treprostinil Injection[9] - Total revenue for the year ended December 31, 2024, was $13,996,000, a decrease of 20.5% compared to $17,488,000 in 2023[24] - The net loss for the year ended December 31, 2024, was $130,394,000, compared to a net loss of $78,502,000 in 2023, representing a 66.3% increase in losses[24] - The net loss per common share, basic and diluted, was $1.66 in 2024, compared to $1.21 in 2023[24] Expenses - Research and development expenses rose to $47.8 million, an increase of 11% from $43.2 million in 2023, driven by higher costs associated with the L606 program and YUTREPIA research[11] - General and administrative expenses surged to $81.6 million, an increase of 82% from $44.7 million in 2023, largely due to higher personnel costs and legal fees related to ongoing litigation[12] - Total costs and expenses increased significantly to $135,290,000 in 2024, up 48.9% from $90,872,000 in 2023[24] - Research and development expenses rose to $47,842,000 in 2024, an increase of 10.5% from $43,242,000 in 2023[24] - General and administrative expenses surged to $81,569,000 in 2024, up 82.2% from $44,742,000 in 2023[24] Cash and Assets - Cash and cash equivalents increased to $176.5 million as of December 31, 2024, compared to $83.7 million at the end of 2023, representing a growth of 110.5%[8] - The accumulated deficit as of December 31, 2024, was $559,492,000, compared to $429,098,000 at the end of 2023[24] - Total assets grew to $230,313,000 in 2024, compared to $118,332,000 in 2023[24] - Total stockholders' equity increased to $77,275,000 in 2024, up from $47,293,000 in 2023[24] Regulatory and Clinical Developments - The FDA granted tentative approval for YUTREPIA on August 16, 2024, with potential for final approval after the expiration of regulatory exclusivity on May 23, 2025[3] - The ASCENT study for YUTREPIA is nearing enrollment completion, showing promising tolerability and titratability in patients with PH-ILD[4] - Liquidia is advancing clinical studies for L606, with ongoing safety studies in patients with PAH and PH-ILD, aiming for a pivotal study to support approval[5] - The company anticipates receiving $50 million upon the first commercial sale of YUTREPIA following FDA approval, contingent on no injunctions against commercialization[7] Financing - Liquidia has strengthened its financial position with an amendment to its financing agreement with HCRx, providing up to an additional $100 million in funding[7]

Core Insights - Liquidia Corporation reported financial results for the full year ended December 31, 2024, highlighting a strengthened financial position and progress towards the potential approval of YUTREPIA [1][2][8] Financial Performance - Cash and cash equivalents increased to $176.5 million as of December 31, 2024, compared to $83.7 million as of December 31, 2023 [7] - Revenue for the year was $14.0 million, a decrease from $17.5 million in 2023, primarily due to lower sales quantities of Treprostinil Injection [9] - Cost of revenue rose to $5.9 million from $2.9 million in the previous year, attributed to sales force expansion [10] - Research and development expenses increased by 11% to $47.8 million, driven by higher costs related to the L606 program and YUTREPIA activities [11] - General and administrative expenses surged by 82% to $81.6 million, mainly due to increased personnel costs and legal fees [12] - Net loss for the year was $130.4 million, or $1.66 per share, compared to a net loss of $78.5 million, or $1.21 per share, in 2023 [14] Corporate Developments - Liquidia amended its financing agreement with HCRx to secure up to an additional $100 million, with $25 million received at closing [6] - The FDA granted tentative approval for YUTREPIA for PAH and PH-ILD, with potential final approval expected after the expiration of regulatory exclusivity on May 23, 2025 [3][8] - The ASCENT study for YUTREPIA is nearing enrollment completion, showing promising tolerability and titratability in PH-ILD patients [4] - Clinical studies for L606, a sustained-release formulation of treprostinil, are ongoing, with a pivotal study planned to support approval for both PAH and PH-ILD [5][17] Market Context - YUTREPIA is positioned as a therapeutic alternative for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2][15] - The prevalence of PAH in the U.S. is estimated at 45,000 patients, while PH-ILD affects over 60,000 patients, indicating a significant market opportunity for Liquidia's products [19][20]

Core Insights - Liquidia Corporation has entered into a sixth amendment with HealthCare Royalty to secure up to an additional $100 million in financing for the development of its therapies, particularly YUTREPIA™ [1][2] - The funding will be utilized for the ongoing commercial development of YUTREPIA for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), as well as for other clinical trials and general corporate purposes [1][2] Financing Details - The agreement includes an initial $25 million at closing, with potential additional tranches of $50 million upon the first commercial sale of YUTREPIA after FDA approval, and $25 million upon reaching net sales exceeding $100 million by June 30, 2026 [2] - Payments to HealthCare Royalty are capped at 175% of the total amounts advanced, with minimum rates of return set at 16%, 13%, and 12% for the new tranches [3] Company Overview - Liquidia Corporation focuses on developing innovative therapies for rare cardiopulmonary diseases, with YUTREPIA being its lead candidate for treating PAH and PH-ILD [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] HealthCare Royalty Overview - HealthCare Royalty is a prominent royalty acquisition company that has invested over $5 billion in more than 90 biopharmaceutical products [5]