Liquidia Corp(LQDA)

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Liquidia Corp(LQDA) - 2023 Q1 - Quarterly Report
2023-05-08 12:56
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 | | - ...
Liquidia Corp(LQDA) - 2023 Q1 - Earnings Call Transcript
2023-05-06 22:43
Liquidia Corporation (NASDAQ:LQDA) Q1 2023 Results Conference Call May 4, 2023 8:30 AM ET Company Participants Jason Adair - SVP, Corporate Development and Strategy Roger Jeffs - CEO Michael Kaseta - CFO Rajeev Saggar - CMO Scott Moomaw - Chief Commercial Officer Rusty Schundler - General Counsel Conference Call Participants Greg Harrison - Bank of America Serge Belanger - Needham Julian Harrison - BTIG Kambiz Yazdi - Jefferies Matt Kaplan - Ladenburg Operator Good morning, and welcome, everyone, to the Liq ...
Liquidia Corp(LQDA) - 2022 Q4 - Annual Report
2023-03-20 20:02
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].
Liquidia Corp(LQDA) - 2022 Q4 - Earnings Call Transcript
2023-03-16 17:03
Liquidia Corporation (NASDAQ:LQDA) Q4 2022 Earnings Conference Call March 16, 2023 8:30 AM ET Company Participants Jason Adair - SVP, Corporate Development and Strategy Roger Jeffs - CEO Rajeev Saggar - CMO Rusty Schundler - General Counsel Mike Kaseta - CFO Conference Call Participants Gregory Harrison - Bank of America Kambiz Yazdi - Jefferies Serge Belanger - Needham Julian Harrison - BTIG Matt Kaplan - Ladenburg Thalmann Operator Good morning, and welcome, everyone, to the Liquidia Corporation's Full Ye ...
Liquidia Corp(LQDA) - 2022 Q3 - Quarterly Report
2022-11-08 21:15
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, 2022 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 Corp(LQDA) - 2022 Q3 - Earnings Call Transcript
2022-11-08 19:47
Liquidia Corporation (NASDAQ:LQDA) Q3 2022 Earnings Conference Call November 8, 2022 8:30 AM ET Company Participants Jason Adair – Senior Vice President-Corporate Development and Strategy Roger Jeffs – Chief Executive Officer Rusty Schundler – General Counsel Mike Kaseta – Chief Financial Officer Rajeev Saggar – Chief Medical Officer Conference Call Participants Greg Harrison – Bank of America Chris Howerton – Jefferies Julian Harris – BTIG Matt Kaplan – Ladenburg Serge Belanger – Needham & Company Operato ...
Liquidia Corp(LQDA) - 2022 Q2 - Quarterly Report
2022-08-11 20:07
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, 2022 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 Corp(LQDA) - 2022 Q2 - Earnings Call Transcript
2022-08-11 14:55
Liquidia Corporation (NASDAQ:LQDA) Q2 2022 Earnings Conference Call August 11, 2022 8:30 AM ET Company Participants Jason Adair - Senior Vice President, Corporate Development and Strategy Roger Jeffs - Chief Executive Officer Dr. Rajeev Saggar - Chief Medical Officer Rusty Schundler - General Counsel Mike Kaseta - Chief Financial Officer Conference Call Participants Greg Harrison - Bank of America Serge Belanger - Needham & Company Matt Kaplan - Ladenburg Thalmann Julian Harrison - BTIG Operator Good mornin ...
Liquidia Corp(LQDA) - 2022 Q1 - Quarterly Report
2022-05-12 20:03
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, 2022 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 Corp(LQDA) - 1202 Q1 - Earnings Call Transcript
2022-05-12 17:49
Liquidia Corporation(NASDAQ:LQDA) Q1 2022 Earnings Conference Call May 12, 2022 8:30 AM ET Company Participants Jason Adair - SVP, Corporate Development and Strategy Roger Jeffs - CEO Mike Kaseta - CFO Rusty Schundler - General Counsel Conference Call Participants Serge Belanger - Needham & Company Julian Harrison - BTIG Andreas Argyrides - Wedbush Operator Good morning, and welcome, everyone, the Liquidia Corporation First Quarter 2022 Financial Results and Corporate Update Conference Call. My name is Howa ...