Financial Performance - 2024 total revenues reached $286 million, representing a 43% increase compared to 2023; Q4 2024 revenues were $77 million, up 31% year-over-year[5] - 2024 net income was $28 million, with a non-GAAP net income of $68 million; Q4 2024 net income was $7 million, with a non-GAAP net income of $23 million[5] - Total revenues for Q4 2024 reached $76,776,000, a 31.3% increase from $58,472,000 in Q4 2023[21] - Net income for the year ended December 31, 2024, was $27,588,000, compared to a net loss of $11,938,000 in 2023[21] - The company reported a non-GAAP adjusted net income of $22,952,000 for Q4 2024, compared to $7,147,000 in Q4 2023, indicating a significant improvement[26] - Basic net income per share for Q4 2024 was $0.03, up from $0.01 in Q4 2023[21] Revenue Sources - Revenue from collaborations and services increased by 90% to $100.8 million in 2024, driven by higher manufacturing of Tyvaso DPI[8] Expenses and Liabilities - Total expenses for the year 2024 were $212,917,000, compared to $190,284,000 in 2023, marking an increase of 11.9%[21] - Research and development expenses rose by 47% to $45.9 million in 2024, primarily due to clinical study activities[14] - Research and development expenses increased to $45,893,000 for the year 2024, up from $31,283,000 in 2023, reflecting a 46.7% increase[21] - The company’s total liabilities decreased to $472,659,000 in 2024 from $721,366,000 in 2023, a reduction of 34.5%[23] Cash and Assets - MannKind's cash, cash equivalents, and investments totaled $203 million at year-end 2024[5] - Cash and cash equivalents decreased significantly to $46,339,000 in 2024 from $238,480,000 in 2023, a decline of 80.6%[23] - Total assets decreased to $393,843,000 in 2024 from $475,198,000 in 2023, representing a 17.1% decline[23] Clinical Trials and Approvals - The INHALE-1 Phase 3 clinical trial for Afrezza in pediatrics is progressing, with a planned FDA submission in 1H 2025[6] - The Phase 3 trial of clofazimine inhalation suspension (MNKD-101) is expected to meet interim enrollment targets by the end of 2025[3] - Afrezza was approved in India for adults, with expected shipments in Q4 2025, generating a $1.1 million regulatory milestone[9] - The company anticipates supplemental new drug application filing for Afrezza in 1H 2025, pending FDA feedback[6] Debt Management - The company reduced debt principal by $236 million, leaving a remaining convertible debt of $36 million[5]

Core Viewpoint - MannKind Corporation reported strong financial results for 2024, achieving a revenue run rate of $300 million and significant growth in various business segments, while also advancing its clinical programs for Afrezza and other products [2][5][6]. Financial Performance - Total revenues for 2024 reached $286 million, representing a 43% increase compared to 2023, with fourth-quarter revenues of $77 million, up 31% year-over-year [5][7]. - The company reported a net income of $28 million for 2024, compared to a net loss of $11.9 million in 2023, with fourth-quarter net income of $7 million [5][17]. - Non-GAAP net income for 2024 was $68 million, or $0.25 per share, compared to $5.9 million, or $0.03 per share, in 2023 [5][17]. Business Updates - MannKind appointed Dominic Marasco as President of the Endocrine Business Unit to drive growth for Afrezza, including a planned submission for pediatric approval in summer 2025 [2][6]. - The company is progressing its clinical programs, with the INHALE-1 trial for Afrezza in pediatrics and the Phase 3 trial for clofazimine inhalation suspension expected to meet interim enrollment targets by the end of 2025 [2][3][6]. Pipeline Advancements - The company successfully completed Phase 1 of the nintedanib DPI trial, demonstrating good tolerability with no serious adverse events [6][10]. - Afrezza has been approved in India for adults, with shipments expected in Q4 2025, pending regulatory requirements [6][10]. Balance Sheet Strength - MannKind reduced its debt principal by $236 million during 2024, leaving a remaining convertible debt of $36 million, and ended the year with cash and investments totaling $203 million [5][9]. - The company reported a strong balance sheet, with total assets of $393.8 million as of December 31, 2024 [22].

Core Viewpoint - MannKind Corporation is set to release its 2024 fourth quarter and full year financial results on February 26, 2025, after market close [1] Group 1: Financial Results Announcement - The financial results will be discussed in a webcast starting at 4:30 p.m. Eastern Time, featuring CEO Michael Castagna and CFO Chris Prentiss [2] - The webcast will be accessible on MannKind's investor relations website, with a replay available for approximately 90 days [2] Group 2: Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products for serious unmet medical needs, particularly in endocrine and orphan lung diseases [3] - The company aims to alleviate the burden of diseases such as diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension through its advanced formulation and device engineering capabilities [4] - MannKind's technologies include dry-powder formulations and inhalation devices that enable rapid and convenient delivery of medications to the lungs [4]

MannKind (MNKD) FY 2025 Conference February 11, 2025 11:20 AM ET Company Participants Michael Castagna - CEOChristopher Prentiss - Chief Financial Officer Conference Call Participants Andreas Argyrides - Managing Director & Senior Analyst - Biotechnology Andreas Argyrides Great. Good morning, everyone, and welcome to Oppenheimer's thirty fifth annual Healthcare Life Science Conference. My name is Andreas Zagredes. I'm one of the senior biotech analysts at Oppenheimer. And today, I have the pleasure to be jo ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 06, 2025 (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 its participation at three investor conferences during the first quarter of 2025. MannKind’s Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss will share updates during the fo ...

Company Announcement - Dominic Marasco, RPh, joins MannKind Corporation as President of the Endocrine Business Unit, effective January 6, 2025 [1] - Mr Marasco reports to Michael Castagna, PharmD, CEO, and is expected to drive strategic growth and operational excellence in the Endocrine Business Unit [2] - Mr Marasco brings over 25 years of experience in the biopharma and biotech sectors, including leadership roles at Envision Pharma Group, BioAgilytix Labs, Syneos Health, Amgen, Sandoz Biopharmaceuticals, and Quintiles Transnational Holdings [2][3] - Mr Marasco began his career as a pharmacist and holds a degree from the Philadelphia College of Pharmacy and completed the Harvard Business School’s Advanced Management Program [4] Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products and devices for endocrine and orphan lung diseases [5] - The company aims to address unmet medical needs in diseases such as diabetes, nontuberculous mycobacterial lung disease, pulmonary fibrosis, and pulmonary hypertension [6] - MannKind’s signature technologies include dry-powder formulations and inhalation devices designed for rapid and convenient delivery of medicines to the deep lung [6] - The company’s mission is to empower patients to take control of their health and improve their quality of life [7]

Company debt reduced by $194 millionCash position after closing will be in excess of $180 million DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Dec. 18, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) today announced today that it has entered into separate, privately negotiated exchange agreements with certain holders (the "Holders") of its 2.50% Convertible Senior Notes due 2026 (the "Notes"). Under the terms of the exchange agreements, the Holders agreed to exchange an aggregate principal amoun ...

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 ...