Company plans to meet with FDA regarding potential sNDA submission in 1H 2025Call planned today at 8:30 a.m. (ET) to discuss company's diabetes program progression DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced six-month results from its Phase 3 INHALE-1 study of Afrezza ...

Company plans to meet with FDA regarding potential sNDA submission in 1H 2025Call planned today at 8:30 a.m. (ET) to discuss company’s diabetes program progression DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced six-month results from its Phase 3 INHALE-1 study of Afrezz ...

India has the 2nd highest burden of diabetes worldwideCDSCO decision follows existing approvals in the U.S.A. and BrazilMannKind expects to ship product for Cipla Ltd. by end of 2025 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Dec. 11, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, and Cipla Ltd. announced today that the Centr ...

MannKind Corporation (NASDAQ:MNKD) Q3 2024 Earnings Conference Call November 7, 2024 4:30 PM ET Company Participants Michael Castagna - CEO Chris Prentiss - CFO Conference Call Participants Andreas Argyrides - Oppenheimer Olivia Brayer - Cantor Fitzgerald Faisal Khurshid - Leerink Partners Anish Nikhanj - RBC Capital Markets Brandon Folkes - Rodman & Renshaw Operator Good afternoon, and welcome to the MannKind Corporation Third Quarter 2024 Financial Results Earnings Call. As a reminder, this call is being ...

Financial Data and Key Metrics Changes - Third quarter revenues reached $70 million, a 37% increase compared to the same quarter last year [32] - Year-to-date revenues totaled $209 million, reflecting a 49% increase over the prior year period [32] - GAAP net income for the third quarter was $12 million, compared to $2 million in the prior year quarter [37] - Non-GAAP net income for the third quarter was $15 million, up from $4 million in the prior year [37] - Cash and investments stood at $268 million as of the end of September [39] Business Line Data and Key Metrics Changes - Tyvaso DPI royalties contributed $27 million in third quarter revenue, a 34% increase year-over-year [32] - Collaboration and services revenue was $23 million, a 78% increase from the third quarter of 2023 [33] - Afrezza net revenue for the third quarter was $15 million, a 12% increase due to higher demand and improved gross-to-net [35] - V-Go net revenue was approximately $5 million for the third quarter, a 5% increase [36] Market Data and Key Metrics Changes - The pediatric study for Afrezza is expected to read out shortly at the end of Q4 [28] - The company is focusing on the type 1 diabetes market, with a shift in strategy to grow more in this area [26] Company Strategy and Development Direction - The company is excited about the potential of Clofazamine and nintedanib, with ongoing clinical trials and site activations [9][18] - The strategy includes a focus on profitable growth and realigning the salesforce to enhance Afrezza's market presence [7][27] - The company aims to shift Afrezza from a profitability mindset to a growth mindset in 2025 and beyond [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of Tyvaso DPI and the emerging pipeline, particularly in the NTM lung disease space [5][41] - The company anticipates strong demand growth and manufacturing opportunities for Tyvaso DPI [42] - Management highlighted the importance of upcoming regulatory updates and clinical trial readouts as key value drivers for future growth [40][44] Other Important Information - The company has transitioned to running the Endocrine Business Unit for profitability, contributing approximately $11 million year-to-date in operating income [38] - The pediatric opportunity for Afrezza is significant, with 300,000 children living with type 1 diabetes [28] Q&A Session Summary Question: Insights on 101's market penetration compared to ARIKAYCE - Management indicated that 101 aims to displace ARIKAYCE in the refractory population, with a focus on administration and tolerability [49] Question: Details on 201's Phase 1 study and its implications - Management confirmed that the Phase 1 study showed no adverse reactions, shaping the approach for Phase 2 [52] Question: Differentiation of MNKD 201 from competitors - Management emphasized the potential for reduced side effects compared to oral formulations and the convenience of dosing [58][79] Question: Growth in Afrezza and its market awareness - Management noted a focus on deepening relationships with current prescribers rather than broadening the prescriber base [84]

MannKind (MNKD) reported $70.08 million in revenue for the quarter ended September 2024, representing a year-over-year increase of 36.7%. EPS of $0.04 for the same period compares to $0.02 a year ago.The reported revenue represents a surprise of -9.31% over the Zacks Consensus Estimate of $77.27 million. With the consensus EPS estimate being $0.04, the company has not delivered EPS surprise.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compa ...

MannKind (MNKD) came out with quarterly earnings of $0.04 per share, in line with the Zacks Consensus Estimate. This compares to earnings of $0.02 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.01 per share when it actually produced earnings of $0.05, delivering a surprise of 400%.Over the last four quarters, the company has surpassed consensus EPS estimates three times.MannKind, which belo ...

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 September 30, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . | --- | --- | |----------------------------------------------------------------------------------------|------------------------------------------| | | | | | | ...

EXHIBIT 99.1 mannkind MANNKIND CORPORATION REPORTS 2024 THIRD QUARTER FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Conference Call to Begin Today at 4:30 p.m. (ET) • 3Q 2024 Total revenues of $70M; +37% vs. 3Q 2023 • YTD 2024 Total revenues of $209M; +49% vs. YTD 2023 • YTD 2024 Net income of $20 million; Non-GAAP net income of $45 million • Orphan lung disease studies proceeding as planned o MNKD-101 Phase 3 clinical trial expands globally o MNKD-201 Phase 1 successfully completed; Plan to meet with FDA ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss will share updates during a fireside chat at the 2024 UBS Healthcare Conference in Rancho Palos Verdes, Calif. The ...