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.

Summary of Liquidia's Conference Call Company Overview - **Company**: Liquidia - **Industry**: Biotech, specifically in the cardiopulmonary space - **Lead Product**: Eutrebia, a treatment for Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PHILD) [3][12] Key Points and Arguments Product Development and Approval - Liquidia is approaching its PDUFA date for Eutrebia, which is set for May 24, indicating a potential approval for the treatment of PAH and PHILD [3][15] - Eutrebia utilizes proprietary print technology to create a dry powdered formulation of treprostinil, allowing for better lung deposition and tolerability [3][5] - The company has developed five launch strategies, including product profile development, a best-in-class sales force, patient support services, product availability, and payer access [4][5] Market Dynamics - The reference brand, United Therapeutics' Tyvaso, has a sales run rate of approximately $2 billion, with a market characterized by less than 20% penetration in PHILD [19][21] - Liquidia estimates the PHILD market to have around 60,000 patients, presenting significant growth opportunities [21][30] - The PAH market is described as crowded, with Liquidia aiming to position Eutrebia as the first choice among prostacyclins due to its ability to titrate to higher doses [22][23] Competitive Landscape - Liquidia is aware of ongoing litigation from United Therapeutics, which has filed multiple patents against them to delay Eutrebia's market entry [8][11] - The company is confident in its legal position and is committed to providing alternative treatments for patients [12][69] Sales and Marketing Strategy - Liquidia has a 50-person sales force with extensive experience in PAH, focusing on building relationships with healthcare providers [36][38] - The sales force has engaged in unbranded promotional efforts to educate physicians about the product and its technology [38][39] - The company plans to ensure broad access to Eutrebia through relationships with payers, targeting a market mix of approximately 50% Medicare Part D and 35-40% commercial [48][49] Product Differentiation - Eutrebia is designed to be easy to use, requiring no refrigeration and allowing for quick inhalation [51][55] - The device is familiar to pulmonologists, which may facilitate adoption among patients [55][56] - Liquidia emphasizes the importance of patient-reported outcomes and quality of life improvements as key measures of success [58][61] Future Outlook - Liquidia is preparing for a Phase 3 study of L606, a liposomal sustained release formulation, which could provide a once-daily treatment option [64][66] - The company is focused on maximizing the benefits of inhaled treprostinil and is optimistic about its long-term positioning in the market [66] Additional Important Information - Liquidia has been proactive in manufacturing commercial supply in anticipation of approval, ensuring sufficient product availability at launch [44][45] - The company is committed to addressing the needs of patients with PAH and PHILD, aiming to provide effective treatment options [12][69]

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]