Liquidia Corporation (NASDAQ:LQDA) Q4 2023 Earnings Conference Call March 13, 2024 8:30 AM ET Company Participants Roger Jeffs - CEO Scott Moomaw - CCO Michael Kaseta - COO & CFO Rajeev Saggar - CMO Jason Adair - CBO Rusty Schundler - General Counsel Conference Call Participants Mary Kate Davis - Bank of America Julian Harrison - BTIG Serge Belanger - Needham & Company Matt Kaplan - Ladenburg Thalmann Kambiz Yazdi - Jefferies Operator Good morning, and welcome everyone to the Liquidia Corporation Full-Year ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39724 LIQUIDIA CORPORATION (Exact Name of Registrant as Specified in Its Charter) | Delaware | 85-1710962 | | --- | --- | | ( ...

Exhibit 99.1 Liquidia Corporation Reports Full Year 2023 Financial Results and Provides Corporate Update MORRISVILLE, N.C., March 13, 2024 – Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the full year ended December 31, 2023. The Company will host a webcast at 8:30 a.m. ET to discuss the 2023 financial results and provide a corporate update. Roger Jeffs, Liquidia's Chief Executive Officer, said: "Based on our success last year, we are preparing to become ...

Liquidia will pursue final FDA approval for YUTREPIA™ (treprostinil) inhalation Liquidia will immediately request that District Court set aside injunction tied to '793 patent MORRISVILLE, N.C., Dec. 20, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ:LQDA) (Liquidia or the Company) announced that the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) today affirmed the earlier decision by the Patent Trial and Appeal Board (PTAB) which found all claims of U.S. Patent No. 10,716,793 ('793 P ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal quarter ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39724 LIQUIDIA CORPORATION (Exact Name of Registrant as Specified in Its Charter) | Delaware | 85-1710962 | ...

Liquidia Corporation (NASDAQ:LQDA) Q2 2023 Earnings Conference Call August 10, 2023 8:30 AM ET Company Participants Jason Adair - Chief Business Officer Roger Jeffs - Chief Executive Officer Rusty Schundler - General Counsel Mike Kaseta - Chief Financial Officer Rajeev Saggar - Chief Medical Officer Conference Call Participants Mary Kate - Bank of America Julian Harrison - BTIG Serge Belanger - Needham Kambiz Yazdi - Jefferies Matthew Kaplan - Ladenburg Thalmann Operator Good morning, and welcome everyone t ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal quarter ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39724 LIQUIDIA CORPORATION (Exact Name of Registrant as Specified in Its Charter) | Delaware | 85-1710962 | | -- ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal quarter ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39724 LIQUIDIA CORPORATION (Exact Name of Registrant as Specified in Its Charter) | Delaware | 85-1710962 | | - ...

Financial Data and Key Metrics Changes - Revenue for Q1 2023 was $4.5 million, an increase from $3.5 million in Q1 2022, primarily due to increased quantities and favorable gross to net rebate adjustments [10] - Cost of revenue remained stable at $0.7 million compared to Q1 2022 [10] - Net loss for Q1 2023 was $11.7 million or $0.18 per share, compared to a net loss of $15.9 million or $0.30 per share in Q1 2022, indicating improved financial performance [29] Business Line Data and Key Metrics Changes - Research and development expenses increased to $5.3 million in Q1 2023 from $4.7 million in Q1 2022, primarily due to increased consulting and personnel expenses for YUTREPIA commercialization [17] - General and administrative expenses decreased to $7.8 million from $12.5 million year-over-year, mainly due to reduced legal fees and stock-based compensation [17] - Other expenses totaled $2.5 million, which included a $2.3 million loss on extinguishment of debt related to a loan repayment [17] Market Data and Key Metrics Changes - The market opportunity for YUTREPIA is expanding as physicians gain exposure to inhaled prostacyclin benefits for treating PAH and PH-ILD patients [14] - The company is preparing to launch an open-label study in PH-ILD patients later this year to further define YUTREPIA's product profile [20] Company Strategy and Development Direction - The company is focused on the potential commercialization of YUTREPIA and is actively preparing for its launch, including ramping up production and hiring for commercial and medical affairs teams [24] - The company is involved in ongoing legal appeals that could impact the timing of YUTREPIA's launch, with expectations for decisions within the next few months [15][21] - The restructuring of the GSK agreement allows the company to utilize its PRINT technology for its own development programs, enhancing its competitive advantage [55] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong balance sheet and ongoing legal successes, which are critical for the potential approval and launch of YUTREPIA [14] - The management highlighted the increasing demand for inhaled treprostinil and the growing diagnosis and treatment of PH-ILD as key drivers for future growth [20] - Management anticipates that the timing for full approval and launch of YUTREPIA could occur late this year or in the first half of next year, depending on the outcomes of ongoing appeals [64] Other Important Information - The company ended Q1 2023 with cash and cash equivalents totaling $94.4 million, positioning it well for future objectives [40] - The company has a robust supply chain and in-house manufacturing capabilities, ensuring readiness for market demand upon approval [73] Q&A Session All Questions and Answers Question: Can you provide additional color on the different scenarios regarding the appeals and their impact on YUTREPIA's launch timing? - Management outlined three potential scenarios regarding the appeals, with the most favorable leading to immediate clearance for final FDA approval if both patents are affirmed [35][64] Question: How much could pricing differentiate YUTREPIA from other DPI products? - Management indicated that pricing strategies would be developed post-approval, focusing on positioning YUTREPIA as a preferred product [45] Question: What is the status of the open-label PH-ILD study? - The open-label study is expected to launch by the end of the year, focusing on evaluating utility and tolerability in patients with pulmonary hypertension associated with interstitial lung disease [54] Question: What are the plans for manufacturing capacity at launch? - Management confirmed that they are building commercial supply and are confident in their ability to meet market demand upon receiving approval [50][73]

Financial Performance - The total reported net revenue of branded therapies for PAH and PH-ILD in the U.S. exceeded $4.6 billion in 2022, with $2.7 billion targeting the prostacyclin pathway[30]. - United Therapeutics' treprostinil-based products generated net revenue of $1.7 billion in 2022, with Tyvaso® contributing $873 million, Orenitram contributing $325 million, and Remodulin® contributing $500 million[30]. - The company incurred net losses of $41.0 million for the year ended December 31, 2022, and $34.6 million for the year ended December 31, 2021, with an accumulated deficit of $350.6 million as of December 31, 2022[189]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through clinical trials and seeks regulatory approval[188]. - The company has a history of losses and its future profitability remains uncertain, with the potential for continued negative cash flow[189]. - The company may need to raise additional funds to meet future funding requirements, which may not be available on acceptable terms[192]. - The company is utilizing net proceeds from various financing facilities and equity offerings to support the development and commercialization of YUTREPIA and Treprostinil Injection, as well as for general corporate purposes[198]. - The company must maintain a minimum cash balance of $7.5 million in 2024 and $15.0 million thereafter as part of its financing agreement[196]. Product Development and Approval - YUTREPIA, the lead product candidate, is an inhaled dry powder formulation of treprostinil designed to enhance deep lung delivery and achieve higher dose levels than current inhaled therapies[21]. - The FDA tentatively approved the NDA for YUTREPIA in November 2021, with potential for supplemental NDA to treat PH-ILD upon expiration of regulatory exclusivity in March 2024[21]. - The NDA submission for YUTREPIA included results from pharmacokinetic studies indicating that a single-capsule dose of 79.5 mcg provides comparable pharmacokinetics with nine breaths of Tyvaso[43]. - The FDA completed a Pre-Approval Inspection of Liquidia PAH's facility with no inspectional observations, supporting the review of YUTREPIA NDA[62]. - The company has not yet obtained final marketing approval for any product candidates, which limits its ability to generate revenue from its own pharmaceutical products[203]. - The company received tentative FDA approval for its product candidate YUTREPIA in November 2021, but final marketing approval is uncertain due to ongoing patent litigation[185]. Market Competition and Challenges - The company has faced competition from various approved classes of drugs targeting PAH, including branded and generic products[96]. - Tyvaso, approved for PAH treatment since 2009, will face generic competition from Watson Pharmaceuticals starting January 1, 2026[106]. - Sales of Treprostinil Injection are influenced by market acceptance and competition from generic alternatives, which may lead to declining prices[208]. - The company faces significant competition from large pharmaceutical companies, which may impact its ability to achieve commercial success[185]. Regulatory Compliance and Risks - Compliance with healthcare laws and regulations is critical, as violations could constrain the company's business operations and financial arrangements[176]. - The FDA reviews New Drug Applications (NDAs) to ensure safety and efficacy, assessing preclinical and clinical data, labeling, and manufacturing compliance[130]. - The FDA may issue a complete response letter if the application does not meet approval criteria, outlining specific conditions for resubmission[136]. - The FDA can withdraw product approval if regulatory compliance is not maintained or if new problems arise post-market[157]. - The Drug Supply Chain Security Act (DSCSA) requires compliance from trading partners in the drug supply chain, including product tracing and transaction information exchange, with implementation efforts continuing through 2023[159]. Strategic Partnerships and Collaborations - Liquidia PAH partnered with Sandoz to market and commercialize Treprostinil Injection, launched in March 2019 as the first fully-substitutable generic for parenteral administration[46]. - The Promotion Agreement with Sandoz allows Liquidia PAH to receive 50% of net profits up to $500 million and 75% for profits exceeding that amount until December 31, 2028[71]. - Liquidia PAH and Sandoz entered a collaboration with Mainbridge Health Partners to develop a new subcutaneous pump, with a 510(k) submission anticipated in 2023[52]. Research and Development - The company is considering conducting additional clinical trials, including one in pediatric patients, to generate more data supporting YUTREPIA's use[44]. - Liquidia PAH's proprietary PRINT technology enables the engineering of drug particles for improved pharmacological benefits, including prolonged drug release and enhanced stability[54]. - The company has developed the RG Cartridge, which received FDA 510(k) clearance in March 2021, essential for administering Treprostinil Injection[215]. Employee and Operational Insights - As of March 2, 2023, the company employed 63 individuals, all located in the United States[104]. - The company emphasizes the importance of attracting and retaining skilled employees through competitive salaries and a robust employment package[105]. - The corporate headquarters spans approximately 45,000 square feet, with a lease expiring on October 31, 2026, and an option to renew for five additional years[108]. Financial and Market Outlook - The company is dependent on third-party manufacturers for Treprostinil Injection and the RG Cartridge, which poses risks related to compliance and supply[185]. - The company is seeking to develop new pumps for administering Treprostinil Injection, requiring FDA clearance, with no guarantee of success[216]. - Recent tax legislation changes could adversely impact the company's business and financial condition[200]. - The company may face limitations on using net operating loss carryforwards due to potential ownership changes triggered by past equity offerings[199].