MannKind (MNKD) Q1 2025 Earnings Call May 08, 2025 09:00 AM ET Speaker0 Good morning, and welcome to the MannKind Corporation First Quarter twenty twenty five Financial Results Earnings Call. As a reminder, this call is being recorded on 05/08/2025 and will be available for playback on the MannKind Corporation website shortly after the conclusion of this call and available for approximately ninety days. This call will contain forward looking statements. Such forward looking statements are subject to risks a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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: 000-50865 MannKind Corporation (Exact name of registrant as specified in its charter) Delaware 13-3607736 (State or other jurisdiction of in ...

EXHIBIT 99.1 • Planning to advance into the next phase of global development in 2H 2025 • 1Q 2025 revenues of $78M, +18% v. 1Q 2024 • 1Q 2025 net income of $13M, + 24% v. 1Q 2024 • 1Q 2025 non-GAAP net income of $22M, +43% v. 1Q 2024 • Advanced pipeline: • Expect to submit sBLA for Afrezza ® in pediatric patients in mid-2025 • MNKD-101: NTM global Phase 3 trial enrollment on track for interim analysis • MNKD-201: Expect to continue to next phase of global development in 2H 2025 MANNKIND CORPORATION REPORTS ...

Conference call to provide corporate updates today at 9:00 am ET 1Q 2025 revenues of $78M, +18% v. 1Q 20241Q 2025 net income of $13M, + 24% v. 1Q 20241Q 2025 non-GAAP net income of $22M, +43% v. 1Q 2024Advanced pipeline: Expect to submit sBLA for Afrezza® in pediatric patients in mid-2025MNKD-101: NTM global Phase 3 trial enrollment on track for interim analysisMNKD-201: Expect to continue to next phase of global development in 2H 2025 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 08, 2025 (GLOBE NEWSWI ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), announced today that its first quarter 2025 financial results will be released before market open on May 8, 2025. MannKind will host a webcast beginning at 9:00 a.m. Eastern Time to discuss the financial results and provide a business update. Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss will participate in the conference call from MannKind. The we ...

Core Insights - MannKind Corporation continues its partnership with Juncos Hollinger Racing and driver Conor Daly for the 2025 NTT INDYCAR Series season, emphasizing its commitment to raising awareness about diabetes through innovative marketing strategies [1][3][4] Company Overview - MannKind Corporation specializes in the development and commercialization of inhaled therapeutic products and delivery devices aimed at addressing serious unmet medical needs, particularly for patients with endocrine and orphan lung diseases [7][8] - The company utilizes dry-powder formulations and inhalation devices to provide rapid and convenient delivery of medicines, enhancing patient control over their health [8][9] Marketing and Sponsorship - MannKind will serve as the primary sponsor for the No. 76 Chevrolet at the Acura Grand Prix of Long Beach on April 13, featuring a provocative tagline "Tired of Pricks?" to promote its diabetes treatment initiatives [2][3] - The company plans to extend its sponsorship to additional races, including the Chevrolet Detroit Grand Prix on June 1 and the World Wide Technology Raceway on June 15, while maintaining an associate sponsorship throughout the 2025 season [3] Driver Profile - Conor Daly, the only known U.S. professional racing driver competing full-time with type 1 diabetes, aims to share his personal story and demonstrate that living with diabetes does not hinder competitive performance [4][5] - Daly has a notable racing history, including a career-best 6th-place finish at the Indy 500 in May 2022 and significant achievements in both IndyCar and NASCAR [5][6]

Core Insights - MannKind Corporation will present data on inhaled insulin at the 18th International Conference on Advanced Technologies and Treatments for Diabetes in Amsterdam from March 19-22, 2025 [1][2] Group 1: Study Presentations - The conference will feature five presentations related to inhaled insulin, including topics such as the efficacy of inhaled insulin in pediatric and adult populations [2][3] - Dr. Kevin Kaiserman emphasized the importance of Afrezza as a treatment option for adults with diabetes, particularly for those using multiple daily injections (MDI) and automated insulin delivery (AID) systems [2] - Specific presentations include the INHALE-1 pediatric study and the INHALE-3 adult study, showcasing sustained benefits and comparisons with usual care [3][4] Group 2: Study Details - The INHALE-1 study is a Phase 3 trial involving 230 pediatric subjects aged 4-17, comparing inhaled insulin with multiple daily injections over a 26-week period [6] - The INHALE-3 study involved 141 adult participants, assessing the efficacy of inhaled insulin combined with basal insulin versus standard care over a 17-week period [7][8] - Both studies reported positive outcomes, with the INHALE-3 study meeting its primary efficacy endpoint of non-inferior change in HbA1c levels [9] Group 3: Company Overview - MannKind Corporation focuses on developing inhaled therapeutic products for endocrine and orphan lung diseases, utilizing advanced formulation and device engineering [12][13] - The company aims to address unmet medical needs through innovative delivery methods, particularly for conditions like diabetes and pulmonary diseases [13][14]

Core Insights - The article discusses a financial analysis framework focusing on healthcare and technology investments, emphasizing a conservative investment strategy that allocates 90% to stable investments and 10% to growth opportunities [1]. Valuation Framework - The base valuation framework projects free cash flows over a 9-year period, starting from a baseline year, applying consistent annual growth rates and discounting cash flows using CAPM to account for time value and risk factors [1]. - Terminal value is calculated by projecting Year 9 cash flows and applying a sustainable long-term growth rate, assuming steady growth patterns and discount rates that exceed long-term growth [1]. Pharmaceutical Revenue Model - The pharmaceutical revenue model assumes a market adoption rate starting at 12.5% at launch, growing linearly to 100% by peak sales year, with a sharp decline of 80% in the first year post-exclusivity [1]. - Revenue is calculated based on the number of patients, market penetration, and annual treatment costs, with costs scaling proportionally with revenue [1]. - The model incorporates a probability of success to account for development and regulatory risks, with cash flows discounted to present value using a standard discount rate [1].

Financial Data and Key Metrics Changes - Fourth quarter revenues were $77 million, a 31% increase over the previous year's fourth quarter [35] - Full year revenues reached $286 million, a 43% increase compared to the prior year [35] - Net income for 2024 was $28 million, or $0.10 per share, compared to a net loss of $12 million, or $0.04 per share for 2023 [41] - The year-end cash position was $203 million, with a debt reduction of $236 million in 2024 [42] Business Line Data and Key Metrics Changes - The endocrine business unit achieved record revenues of $23 million in Q4 and $82 million for the full year [6] - Afrezza net revenue for Q4 was $18 million, an 18% increase, and $64 million for the full year, a 17% increase [37] - V-Go net revenue was approximately $5 million for Q4, a 1% increase, but full year revenues decreased by 4% to $18 million [38] Market Data and Key Metrics Changes - Tyvaso DPI royalties contributed $27 million in Q4, a 28% increase, and $102 million for the year, a 42% increase [36] - DPI-related revenues exceeded $200 million for the year, marking a significant milestone for the Technosphere platform [18] Company Strategy and Development Direction - The company focuses on five key pillars, including two FDA-approved products and funding for pipeline opportunities [5] - The strategy includes expanding the pediatric market for Afrezza and exploring gestational diabetes [11][14] - The company aims to leverage its strong balance sheet to support growth and pipeline development [42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for significant growth in the pediatric market for Afrezza [15] - The company is preparing for upcoming FDA meetings and expects to advance its pipeline projects [33][45] - Management emphasized the importance of effective reimbursement and education strategies for successful product launches [72][75] Other Important Information - The company successfully reduced its debt and improved its cash position, providing a strong foundation for future growth [42] - The collaboration with Amphastar is expected to enhance the pediatric footprint and expedite the filing for pediatric indications [7] Q&A Session Summary Question: Can you talk about margins over the next few quarters? - Management indicated that margins are expected to stabilize as manufacturing utilization increases with Tyvaso DPI and Afrezza [52] Question: Can you provide more details on gross to net discounting and rebates? - Management noted that the current discounting trends are expected to continue throughout the year [54] Question: How do you balance operational profitability with investment in Afrezza? - Management stated that capital deployment will focus on driving the best returns for shareholders while preparing for the pediatric launch [60] Question: What are the critical success factors for Afrezza in pediatrics? - Management identified reimbursement processes, institutional selling capabilities, and education as key factors for success [71][75] Question: What are the expectations for the agreement with CIPLA in India? - Management anticipates that the agreement could lead to significant volume implications and improve overall efficiency [78] Question: What are the safety and efficacy endpoints for the upcoming FDA meeting? - Management plans to discuss various endpoints and trial designs with the FDA, aiming for a solid foundation for future milestones [86][88]

MannKind Corporation (NASDAQ:MNKD) Q4 2024 Earnings Conference Call February 26, 2025 4:30 PM ET Corporate Participants Michael Castagna - Chief Executive Officer Chris Prentiss - Chief Financial Officer Conference Call Participants Olivia Brayer - Cantor Fitzgerald Faisal Khurshid - Leerink Partners Anish Nikhanj - RBC Capital Markets Andreas Argyrides - Oppenheimer Brandon Folkes - Rodman & Renshaw Yun Song - Wedbush Securities Operator Good afternoon and welcome to the MannKind Corporation Fourth Quarter ...