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]

Company Performance - MannKind reported quarterly earnings of $0.02 per share, exceeding the Zacks Consensus Estimate of a loss of $0.01 per share, and improved from a loss of $0.07 per share a year ago, representing an earnings surprise of 300% [1] - The company achieved revenues of $58.47 million for the quarter ended December 2023, surpassing the Zacks Consensus Estimate by 11.67%, and up from $36.06 million in the same quarter last year [1] - Over the last four quarters, MannKind has consistently surpassed consensus EPS and revenue estimates [1] Future Outlook - The sustainability of MannKind's stock price movement will largely depend on management's commentary during the earnings call and future earnings expectations [2] - Current consensus EPS estimate for the upcoming quarter is $0.01 on revenues of $53.4 million, and for the current fiscal year, it is $0.06 on revenues of $236.57 million [4] - The estimate revisions trend for MannKind is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [4] Industry Context - MannKind operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 32% of over 250 Zacks industries, suggesting a favorable industry outlook [5] - The performance of MannKind's stock may also be influenced by the overall industry outlook, as the top 50% of Zacks-ranked industries tend to outperform the bottom 50% by more than 2 to 1 [5] - Zymeworks Inc., another company in the same industry, is expected to report a quarterly loss of $0.39 per share, reflecting a year-over-year change of -108.4%, with revenues anticipated to be $18.32 million, down 95.5% from the previous year [5][6]

EXHIBIT 99.1 mannkind MANNKIND CORPORATION REPORTS 2023 FOURTH QUARTER AND FULL YEAR FINANCIAL RESULTS: PROVIDES CLINICAL DEVELOPMENT UPDATE Conference Call to Begin Today at 5:00 p.m. (ET) • 2023 Total revenues of $199M; +99% vs. 2022 • 4Q 2023 Total revenues of $58M; +62% vs. 2022 • 4Q 2023 Net income of $1M; Non-GAAP net income of $7M • $302M of cash and cash equivalents and investments at December 31, 2023 DANBURY, Conn. and WESTLAKE VILLAGE, Calif. February 27, 2024 (Globe Newswire) — MannKind Corporat ...

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

Core Insights - MannKind Corporation has successfully enrolled 305 patients with type 1 or type 2 diabetes in its INHALE-1 study, which focuses on the efficacy and safety of inhaled insulin in the pediatric population [1][2] - The primary endpoint analysis is anticipated to be completed in the fourth quarter of 2024, with data dissemination and FDA submission expected in 2025 [1][3] Company Overview - MannKind Corporation specializes in the development and commercialization of innovative therapeutic products for endocrine and orphan lung diseases, utilizing dry-powder formulations and inhalation devices for effective drug delivery [4] - The company aims to address serious unmet medical needs, particularly in diabetes management, pulmonary arterial hypertension, and nontuberculous mycobacterial lung disease [4] Study Details - The INHALE-1 study is a 26-week open-label, randomized clinical trial with a 26-week extension, focusing on the change in HbA1c levels as the primary endpoint [2] - Secondary endpoints include changes in fasting plasma glucose and the rate of hypoglycemic events, comparing Afrezza in combination with basal insulin against multiple daily injections of insulin in children and adolescents aged 4-17 [2]

Core Viewpoint - MannKind's recent sale of a 10% stake in Tyvaso DPI for $150 million upfront, with potential additional payments, highlights the company's financial maneuvering despite a 14% decline in stock since October [1][9]. Financial Performance - MannKind reported a significant year-over-year revenue increase to $51.253 million from $32.825 million for Q3 2023, resulting in a profit of $1.721 million compared to a net loss previously [4]. - The company's liquidity improved with $144.3 million in assets, including $83 million in cash and equivalents, and a current ratio of 1.50, indicating sound short-term liquidity [5]. - The enterprise value of MannKind is estimated at $1.18 billion, with projections indicating revenue growth from $193.64 million in 2023 to $306.82 million by 2025 [2][6]. Market Position and Competition - Tyvaso DPI's sales reached $205 million in Q3 2023, up 225% year-over-year, with expectations of reaching $1.9 billion in trailing 12-month revenue by the end of 2026 [2]. - Liquidia's upcoming product YUTREPIA, which uses the same active ingredient as Tyvaso, may pose competitive pressure, but it is not expected to significantly impact Tyvaso's market share [3][9]. Market Sentiment - MannKind's market capitalization is approximately $946.21 million, with a high short interest of 13.31%, indicating bearish sentiment among investors [6][8]. - Institutional ownership stands at 50.47%, with mixed changes in holdings among major institutional investors, suggesting a cautious but engaged investor base [8]. Strategic Outlook - The recent Tyvaso DPI deal is seen as a positive step for MannKind, potentially leading to a reevaluation of its stock value [9]. - The company is committed to innovation, as evidenced by increased research and development spending, despite concerns over share dilution due to an increase in shares outstanding [4][5].

Financial Data and Key Metrics Changes - Total revenues grew 56% year-over-year in Q3 2023 and 121% for the nine months ended compared to the same period in 2022, driven by the launch of Tyvaso DPI and growth in the endocrine business [15][16] - The company achieved a net income of $2 million in Q3 2023, marking its first profitable quarter in history, compared to a net loss of $14 million in the same quarter last year [21][22] - The gross margin for commercial products was reported at 78%, an increase from previous quarters, attributed to improved efficiencies in Afrezza and V-Go products [34] Business Line Data and Key Metrics Changes - Tyvaso royalty revenue exceeded $20 million in Q3 2023, with collaboration services revenue of $13 million, reflecting strong patient demand [16][17] - The endocrine business generated total revenues of $18 million, with Afrezza net revenue increasing by 24% year-over-year to $13 million, driven by higher patient demand [17][18] - V-Go net revenue was $4 million in Q3 2023, an 18% decline compared to 2022, but the downward trend has stabilized [18] Market Data and Key Metrics Changes - The company reported a current run rate of over $200 million in revenues, with approximately 40% from royalties, which contribute directly to the bottom line [20] - The insulin market remains relatively flat to a small single-digit decline year-over-year, with Afrezza showing resilience against market changes [10] Company Strategy and Development Direction - The company is focused on expanding its pipeline, particularly in the orphan lung space and diabetes business, with significant progress in clinical trials for MannKind-101 and MannKind-201 [24][26] - The management emphasized the importance of capital allocation and deleveraging to enhance shareholder value while investing in growth drivers [26] - The company aims to leverage its manufacturing capacity to serve 25,000 to 35,000 patients annually, with potential to increase to 50,000 through efficiencies [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the strong position of the company and the potential for growth in both the orphan lung and endocrine markets [23][24] - The management acknowledged the impact of GLP-1 medications on the diabetes market but maintained that the need for insulin, particularly for Type 1 diabetes patients, remains strong [36] - The company expects to continue seeing growth in revenues and patient demand, particularly for Tyvaso DPI, as out-of-pocket costs for patients are capped under Medicare [45] Other Important Information - The company has begun paying down its mid-cap debt and expects to manage cash flows tightly, with only a $2 million reduction in cash and investments in Q3 2023 [22] - The management is preparing for regulatory submissions and trial initiations in 2024, with a focus on maintaining momentum in clinical development [25][48] Q&A Session Summary Question: How will the INHALE trials shape the trajectory of Afrezza? - Management indicated that data from the INHALE trials will drive decisions regarding the commitment to the endocrine business and Afrezza, with expectations for improved efficacy and tolerability based on trial outcomes [30] Question: What are the economics of Tyvaso DPI? - The royalty rate for Tyvaso DPI is fixed at 10% on net sales, with collaboration services revenue on a cost-plus basis, leading to a margin of over 20% [31] Question: What is the outlook for gross margins? - The gross margin for commercial products was reported at 78%, with expectations for this level to be sustainable moving forward [34] Question: Is there any impact from GLP-1s on the diabetes business? - Management noted that while GLP-1s may slow growth in the diabetes market, they do not expect a significant impact on Afrezza, as Type 1 patients will still require insulin [36] Question: What are the next steps for IND submissions and trial designs? - The company is on track to file INDs for MannKind-101 and MannKind-201, with ongoing discussions with the FDA to streamline trial designs [48]

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, 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: 000-50865 MannKind Corporation (Exact name of registrant as specified in its charter) Delaware 13-3607736 (State or other jurisdiction o ...