DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2024 first quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, May 8, 2024. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at https://investors.mannkindcorp.com/events-and-presentations under Ev ...

Core Viewpoint - MannKind Corporation is advancing its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF), with participant enrollment expected to begin in June 2024 [1][2]. Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products and devices aimed at addressing serious unmet medical needs in endocrine and orphan lung diseases [4]. - The company utilizes dry-powder formulations and inhalation devices to deliver medications effectively to the lungs, targeting conditions such as diabetes, nontuberculous mycobacterial lung disease, pulmonary fibrosis, and pulmonary hypertension [4]. Clinical Study Details - The Phase 1 study will be randomized, double-blind, placebo-controlled, and will assess the safety, tolerability, and pharmacokinetics of nintedanib inhalation powder in healthy volunteers [2]. - Results from this study are anticipated later in the year, which will inform subsequent studies involving patients with pulmonary fibrotic diseases [3]. Market Context - There are over 250,000 Americans currently living with pulmonary fibrosis, with approximately 50,000 new cases diagnosed annually [3]. - The prevalence of idiopathic pulmonary fibrosis is significant, with estimates suggesting that 1 in 200 adults over the age of 70 in the U.S. are affected [3].

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 29, 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 the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study f ...

Core Viewpoint - MannKind Corporation has successfully repaid all outstanding debts under its credit agreement with MidCap Financial Trust and a convertible note issued to Mann Group LLC, significantly reducing its total debt by approximately $41.8 million since December 31, 2023 [1][2][3] Debt Repayment Details - On April 1, 2024, MannKind made a payment of approximately $31.6 million to fully satisfy its obligations under the Loan Agreement, which included an exit fee of $2.8 million and a prepayment fee of approximately $0.3 million [2] - The repayment resulted in the automatic termination of all liens, mortgages, and security interests related to the Loan Agreement, releasing MannKind and its subsidiaries from all guarantees [2] - On April 2, 2024, MannKind satisfied its obligations under the convertible note by paying approximately $8.9 million and issuing 1.5 million shares of common stock, fully terminating all obligations under the Note [3] Management Commentary - The CEO of MannKind stated that repaying the MidCap loan eliminates the company's most expensive debt and releases its assets from security interests, which is a strategic move for future financial flexibility [3] - The CEO also expressed the belief that the company's stock price is currently undervalued, leading to the decision to repay the Mann Group debt through a partial conversion to reduce future potential dilution by over two million shares [3] Company Overview - MannKind Corporation focuses on developing and commercializing innovative therapeutic products and devices for patients with endocrine and orphan lung diseases [4] - The company aims to address serious unmet medical needs using its formulation capabilities and device engineering, particularly for conditions like diabetes and pulmonary arterial hypertension [4] - MannKind's technologies include dry-powder formulations and inhalation devices that provide rapid and convenient delivery of medicines [4]

Post-meal hyperglycemia was significantly reduced by 20% with inhaled insulin compared with rapid-acting insulin delivered through MDI or insulin pumpsSubjects utilizing inhaled insulin experienced a 22% decrease in mean glucose excursions in the first two hours compared to the standard of care17-week primary endpoint results will be presented during a 90-minute symposium at the American Diabetes Association's Scientific Sessions in June DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 11, 2024 (GLOBE NEW ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 05, 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, announced today that new clinical data from the INHALE-3 study first meal challenge will be presented at the upcoming 17th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence on March 6-9. INHAL ...

WESTLAKE VILLAGE, Calif. and DANBURY, Conn., March 04, 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, announced today that it will be participating at upcoming conferences. Leerink Partners Global Biopharma Conference 2024 – Investor Meetings, Monday, March 11, 2024 Oppenheimer 34th Annual Healthcare MedTech & Services Conference – Corpor ...

WESTLAKE VILLAGE, Calif. and DANBURY, Conn., March 04, 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, announced today that it will be participating at upcoming conferences. Leerink Partners Global Biopharma Conference 2024 – Investor Meetings, Monday, March 11, 2024 Oppenheimer 34th Annual Healthcare MedTech & Services Conference – Corpora ...

Financial Data and Key Metrics Changes - Total revenues for 2023 doubled compared to 2022, reaching nearly $200 million, with a 62% increase in Q4 2023 versus Q4 2022 [23][24] - Tyvaso DPI royalty revenue for Q4 was $21 million, a 132% increase year-over-year, while full-year royalty revenue reached $72 million, up 361% from 2022 [24][25] - The endocrine business unit reported total revenues of $20 million for Q4 and $74 million for the full year, with Afrezza's net revenue growing 27% year-over-year [25][26] Business Line Data and Key Metrics Changes - The endocrine business unit contributed approximately 37% of total revenue in 2023, with Afrezza net revenue increasing by $12 million or 27% year-over-year, marking the largest jump in seven years [5][7][25] - V-Go net revenue for Q4 was $5 million, a 13% decrease from 2022, primarily due to lower patient demand [26] Market Data and Key Metrics Changes - The Endocrine business grew 32% year-over-year, contributing $20 million in Q4 and a run rate of $80 million [6][25] - The company anticipates significant market potential expansion with several clinical readouts expected in 2024 [7][10] Company Strategy and Development Direction - The company aims to drive shareholder value by focusing on operational opportunities and maintaining a strong financial position, having sold a portion of Tyvaso royalty for $150 million [4][5] - The Endocrine business is seen as a core pillar for future growth, with plans to optimize sales force capabilities and enhance prescriber adoption [8][9] - The company is also focusing on expanding its pipeline with new clinical trials for MNKD-101 and MNKD-201, targeting significant market opportunities in NTM and IPF [16][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the company's strong financial position and the potential for double-digit growth in the endocrine business [5][6] - The management emphasized the importance of upcoming clinical data from INHALE-1 and INHALE-3 trials, which are expected to drive future growth [10][12] Other Important Information - The company ended 2023 with $302 million in cash and investments, positioning itself well for future investments in clinical trials and debt reduction [37][38] - The company has restructured its insulin purchase commitments, reducing near-term cash outlay by $50 million [5] Q&A Session Summary Question: Can you elaborate on the differences with the DPI device compared with competitors? - The DPI device offers advantages in ease of use and safety, with a focus on deep lung penetration and minimal powder containment, which enhances patient satisfaction and dosing consistency [46][48] Question: How does NTM fit into your strategic priorities? - The company plans to target refractory patients first and is exploring partnerships for international licensing, while also developing a dry powder version for earlier treatment lines [51][52] Question: What data will be presented at ATTD? - The presentation will include first dose and meal tolerance data for Afrezza, aiming to highlight its advantages in treatment [54][55] Question: How is the sales force being optimized? - The company is reallocating resources to create key account managers and reimbursement specialists to enhance future growth capabilities [56]

Core Insights - MannKind reported revenue of $58.47 million for the quarter ended December 2023, marking a 62.2% increase year-over-year [1] - The earnings per share (EPS) was $0.02, a significant improvement from -$0.07 in the same quarter last year [1] - The revenue exceeded the Zacks Consensus Estimate of $52.36 million by 11.67%, while the EPS surpassed the consensus estimate of -$0.01 by 300% [1] Revenue Breakdown - Royalties and collaborations revenue reached $21.03 million, exceeding the average estimate of $19.25 million by analysts, representing a 120.3% increase year-over-year [2] - Revenue from collaborations and services was $17.25 million, surpassing the average estimate of $15.46 million [2] - Net revenue from commercial product sales was $20.20 million, compared to the average estimate of $19.42 million, reflecting a 15.8% year-over-year change [2] Stock Performance - MannKind shares have returned +1.7% over the past month, while the Zacks S&P 500 composite increased by +3.8% [2] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [2]