MORRISVILLE, N.C., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that members of the company’s executive leadership team will be providing an update on the company's business during a fireside chat at the 2025 Wells Fargo Healthcare Conference on Wednesday, September 3, 2025, beginning at 3:45 p.m. ET in Boston. Access to a webcast of the presentation will be available to investors and other interested parties by accessing Liquidia’s website at https://liquidia.com/in ...

Summary of Liquidia Corp (LQDA) 2025 Conference Call Company Overview - **Company**: Liquidia Corp (LQDA) - **Product**: Eutrebia, an inhaled treprostinil formulation approved for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [4][12] Key Points and Arguments Product Approval and Launch - Eutrebia received approval on May 23, 2025, for both PAH and PHILD, allowing simultaneous launch into both indications [4][12] - The product is based on PRINT technology, enabling the creation of dry particles in the respirable range, which enhances efficacy, safety, and convenience [4][5] Differentiation Factors - **Safety**: Eutrebia avoids upper airway deposition, reducing cough and throat irritation, which are common with incumbent products [5] - **Efficacy**: The formulation allows for higher therapeutic doses, potentially 3 to 4 times the current standard [5] - **Convenience**: The low resistance device does not require energy for de-aggregation, making it easier for patients to use [5][6] Market Potential - Historical precedents in the PAH market suggest that addressing safety, efficacy, and convenience can lead to significant market share conversion within 12 to 18 months [6][10] - The oral prostacyclin market is valued at $2 billion in North America, with Tyvaso generating similar revenue, indicating a substantial opportunity for Eutrebia [32] Pricing and Patient Access - Eutrebia is priced at parity with Tyvaso DPI, ensuring competitive positioning [12][13] - A 28-day voucher program allows patients to start therapy immediately while awaiting reimbursement, enhancing access [13][14] Launch Metrics and Supply Chain - Shipments began five business days post-approval, with patient prescriptions filled shortly thereafter [15] - The company has built a robust supply chain, ensuring sufficient inhaler availability for a successful launch [16][17] Sales Strategy - Liquidia has a sales force of approximately 60, targeting 6,500 key prescribers across 150 centers of excellence and 750 community centers [21][22] - The company aims to match or exceed the share of voice of competitors, focusing primarily on Eutrebia [23] Clinical Data and Reception - Initial data from the ASCENT study shows promising tolerability and efficacy, with only one dropout due to a respiratory infection among the first 20 patients [25][26] - There is significant enthusiasm among doctors for transitioning patients from nebulized Tyvaso to Eutrebia, indicating a potential shift in treatment paradigms [29] Future Studies and Development - A prospective study will be initiated to demonstrate the efficacy of transitioning patients from nebulized therapies to Eutrebia [31] - Liquidia is also developing L606, a next-generation liposomal formulation aimed at providing a twice-daily dosing option [46][49] Legal Landscape - Liquidia has faced multiple lawsuits from United Therapeutics but has been successful in defending its position, with ongoing litigation expected to resolve favorably [59][60] Financial Outlook - The company anticipates reaching profitability within three to four quarters post-launch, supported by efficient processes and existing cash reserves [37][38] Additional Important Points - Liquidia is focused on changing the standard of care for PAH and PHILD patients, aiming to establish Eutrebia as the first-choice treatment option [32][36] - The company is preparing to provide detailed launch metrics and patient access information in future earnings calls [18][19] This summary encapsulates the critical insights from the Liquidia Corp conference call, highlighting the company's strategic positioning, product differentiation, market potential, and future growth plans.

Core Insights - Liquidia Corporation has announced the first commercial shipment of YUTREPIA™ (treprostinil) inhalation powder, following FDA approval on May 23, 2025, for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1][6] - The company has moved quickly to promote YUTREPIA, with its sales force actively engaging in the market just over a week after FDA approval [2] - A recent court ruling denied United Therapeutics' request for a preliminary injunction against Liquidia, allowing for the full commercial launch of YUTREPIA [2] Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for rare cardiopulmonary diseases, particularly in pulmonary hypertension [9] - The company utilizes its proprietary PRINT technology to create drug formulations, including YUTREPIA, which is designed for enhanced lung deposition [5][9] - Liquidia is also developing L606, a sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [9] Product Information - YUTREPIA is an inhaled dry-powder formulation of treprostinil, delivered through a user-friendly device, aimed at providing a new therapeutic option for patients with PAH and PH-ILD [5][6] - The product was previously known as LIQ861 during investigational studies and has undergone clinical trials to establish its safety and efficacy [5] Disease Context - PAH is a rare, chronic disease affecting approximately 45,000 patients in the U.S., with no current cure, making symptom management and quality of life improvement critical [3] - PH-ILD encompasses a range of pulmonary diseases affecting over 60,000 patients in the U.S., with associated poor survival rates [4]

Core Insights - Liquidia Corporation will provide a business update during a fireside chat at the 2025 Jefferies Global Healthcare Conference on June 4, 2025 [1] - The event will feature key executives including the CEO, CFO, and Chief Business Officer [1] Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for rare cardiopulmonary diseases [3] - The company is currently developing and commercializing products for pulmonary hypertension using its proprietary PRINT Technology [3] - Liquidia's approved product, YUTREPIA™ (treprostinil) inhalation powder, is used for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [3] - The company is also working on L606, an investigational sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [3]

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]

Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2024, was $14 million, a decrease from $17.5 million for the year ended December 31, 2023, primarily due to lower sales quantities related to the promotion agreement [21] - Cost of revenue increased to $5.9 million in 2024 from $2.9 million in 2023, attributed to sales force expansion [23] - Research and development expenses rose to $47.8 million in 2024 from $43.2 million in 2023, an increase of 11% driven by various program costs [24] - General and administrative expenses surged to $81.6 million in 2024 from $44.7 million in 2023, an increase of 82% primarily due to higher personnel and legal expenses [25] - The net loss for 2024 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 [25] Business Line Data and Key Metrics Changes - The decrease in revenue was primarily due to limitations on the availability of pumps used for administering treprostinil injections [22] - The company is advancing the clinical profile of YUTREPIA, with positive patient responses noted in the ASCENT trial [12][15] Market Data and Key Metrics Changes - The company is preparing for the launch of YUTREPIA in both PAH and PH-ILD markets, which are expected to be significant growth areas [8][9] - The company has established a commercial enterprise to support the use of treprostinil injection and is focused on capturing market share in a growing market segment [16] Company Strategy and Development Direction - The company aims to obtain final approval and launch YUTREPIA as soon as possible after May 23, 2025, when exclusivity for a competitor expires [10] - The strategic imperatives include advancing the clinical profile of YUTREPIA, building commercial capabilities, and innovating new therapeutic options like L606 [9][17] - The company plans to leverage its proprietary PRINT technology to differentiate YUTREPIA from competitors [40] Management Comments on Operating Environment and Future Outlook - Management believes 2025 could be transformational, with expectations for a successful launch of YUTREPIA [8] - The company is optimistic about reaching profitability without additional capital, contingent on the successful launch of YUTREPIA [20][21] - Management expressed confidence in their commercial readiness and relationships with payers to maximize access to YUTREPIA [49][66] Other Important Information - The company announced an expansion of its financing agreement with HealthCare Royalty Partners, providing up to an additional $100 million in financing [20] - The ASCENT trial is on track to complete enrollment with positive early efficacy data reported [12][15] Q&A Session Summary Question: What is the timeline for converting YUTREPIA's tentative approvals to full approvals? - Management plans to request final approval in the coming weeks, aiming for approval around May 23, 2025 [29] Question: What feedback has been received regarding L606? - Physician feedback indicates that twice-a-day dosing is a significant advantage, and the liposomal formulation shows impressive safety benefits [34] Question: What is Liquidia's strategy for early market penetration for YUTREPIA? - The strategy includes increasing awareness and diagnosis of PH-ILD in the community and ensuring YUTREPIA is the first choice for patients [45] Question: What is the breakdown of commercial and Medicare coverage for PAH and PH-ILD? - The breakdown is approximately 50% Medicare, 30-40% commercial, with the remainder from other sources [48] Question: What key readouts should be focused on for the ASCENT study? - Key readouts include the six-minute walk test results, with an observed mean improvement of 26.4% meters reported [53] Question: Will there be additional hiring for the commercial field team post-approval? - The current sales team is fully prepared, and future hiring will be assessed based on market response [59][61] Question: What is the updated cash runway following recent financing? - The company is confident in its ability to reach profitability with the current balance sheet and financing structure [66]