Group 1 - The U.S. FDA approved Liquidia Corporation's LQDA Yutrepia (treprostinil) inhalation powder for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability [1] - In August 2024, the FDA issued tentative approval of Yutrepia for the PAH and PH-ILD indications [1] - Following the announcement, Liquidia shares fell 5.2% to trade at $14.80 [1] Group 2 - Wells Fargo analyst Tiago Fauth maintained an Overweight rating on Liquidia and raised the price target from $20 to $23 [6] - HC Wainwright & Co. analyst Andrew Fein maintained a Buy rating and raised the price target from $29 to $35 [6] - Needham analyst Serge Belanger reiterated a Buy rating and maintained a $25 price target [6]

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]

Product & Approval - YUTREPIA (treprostinil) inhalation powder has received FDA approval [1,3] - YUTREPIA offers a new choice to treat PAH & PH-ILD [11] - The WAC price for a 28-day supply is $24,360, at parity with Tyvaso DPI® [23] Clinical Data & Dosing - YUTREPIA enables a wide range of dosing for both naïve and transition patients [16] - In the INSPIRE study, cough was observed in 27% of transitioning patients and 55% of naïve patients [17] - In the ASCENT study, the median dosing at Week 8 was 132.5 mcg [20] Market & Commercialization - The company is targeting 6,500 physicians treating PH, ILD, or both [27] - The commercial team is fully mobilized and will start detailing today [26] - The field force includes 60 commercial team members, 10 medical science liaisons, field reimbursement specialists, 140 specialty centers and 650 community accounts [27] Patient Support - The company offers full patient support services, including a voucher program, co-pay program, bridge program, and patient assistance program [24]

Liquidia Corp (LQDA) Conference Call Summary Company Overview - **Company**: Liquidia Corporation - **Product**: Utopia, a treprostinil-based product for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [6][22] Key Industry Insights - **Market Need**: There is a significant unmet need in the PAH and PHILD markets, with many patients seeking better treatment options [10][11] - **Regulatory Approval**: Utopia received FDA approval, marking a significant milestone for Liquidia and offering a new treatment option for patients [6][22] Core Product Features - **Innovative Delivery**: Utopia utilizes proprietary PRINT technology, allowing for precise drug particle engineering for deep lung delivery [7][8] - **Dosing Flexibility**: Utopia can be titrated to higher doses than existing inhaled therapies, providing physicians with more control over patient treatment [10][14] - **Patient Experience**: The product is designed to be user-friendly, with a low-resistance dry powder inhaler that requires minimal effort from patients [8][9] Commercial Strategy - **Launch Readiness**: The commercial team is prepared to engage with physicians and drive awareness of Utopia, with detailing starting immediately [19][20] - **Patient Access Programs**: Comprehensive programs are in place to ensure affordability and support for patients, including copay assistance and training [17][18] - **Target Audience**: Initial focus will be on newly diagnosed patients and those currently dissatisfied with existing treatments [19][20] Financial Outlook - **Capital Position**: Liquidia has approximately $170 million in cash, positioning the company well for a successful product launch [22][94] - **Profitability Projections**: The company anticipates achieving profitability within three to four quarters post-launch [23][91] Competitive Landscape - **Market Differentiation**: Utopia is positioned as a superior alternative to existing therapies like Tyvaso, with a focus on dosing flexibility and patient tolerability [10][81][92] - **Switching Strategy**: There is a plan to target patients currently using Tyvaso who may be experiencing side effects, promoting Utopia as a better option [80][81] Additional Considerations - **Ongoing Studies**: Liquidia is committed to further research and development, including studies on next-generation therapies [76][92] - **Payer Engagement**: The company is actively working with payers to ensure broad access to Utopia, aiming to eliminate barriers to treatment [28][68] Conclusion - Liquidia Corporation is poised to make a significant impact in the pulmonary hypertension market with the launch of Utopia, backed by innovative technology, a strong commercial strategy, and a commitment to patient access and support [22][98]

Core Viewpoint - Liquidia Corporation has received FDA approval for YUTREPIA™ (treprostinil) inhalation powder, a new treatment option for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) aimed at improving exercise ability [1][4] Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for rare cardiopulmonary diseases, utilizing its proprietary PRINT™ technology to create drug formulations [10] Product Details - YUTREPIA is the first and only prostacyclin dry-powder formulation designed for deep-lung delivery using a low-effort inhalation device, enhancing patient experience [1][7] - The approval of YUTREPIA is based on the Phase 3 INSPIRE trial, which demonstrated its safety and tolerability for patients naïve to treprostinil and those transitioning from nebulized forms [2][7] Market Impact - The introduction of YUTREPIA provides a new treatment option for over 105,000 patients in the U.S. suffering from PAH and PH-ILD, addressing a significant unmet medical need [2][5] - The product is expected to improve the quality of life for patients, as highlighted by industry leaders and patient advocacy groups [2][6] Legal Considerations - United Therapeutics Corporation has filed a complaint against Liquidia alleging patent infringement related to YUTREPIA, which may impact its commercialization [2][10] Upcoming Events - Liquidia plans to host a live webcast on May 27, 2025, to provide updates on the commercial launch preparations for YUTREPIA [3][4]

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]

MORRISVILLE, N.C., May 12, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that United Therapeutics Corporation (UTHR) filed a complaint on May 9, 2025, in the U.S. District Court for the Middle District of North Carolina (Case No. 1:25-cv-00368) against Liquidia alleging infringement of U.S. Patent No. 11,357,782 (the '782 patent). Additionally, the complaint seeks to en ...

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]

Liquidia Technologies, Inc. (LQDA) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.42. This compares to loss of $0.54 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -7.14%. A quarter ago, it was expected that this company would post a loss of $0.38 per share when it actually produced a loss of $0.46, delivering a surprise of -21.05%.Over the last four quarters, the company ...