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 (MNKD) reported $76.78 million in revenue for the quarter ended December 2024, representing a year-over-year increase of 31.3%. EPS of $0.03 for the same period compares to $0.02 a year ago.The reported revenue represents a surprise of +1.48% over the Zacks Consensus Estimate of $75.66 million. With the consensus EPS estimate being $0.03, the company has not delivered EPS surprise.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compar ...

分组1 - MannKind reported quarterly earnings of $0.03 per share, matching the Zacks Consensus Estimate, and an increase from $0.02 per share a year ago [1] - The company posted revenues of $76.78 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 1.48%, and up from $58.47 million year-over-year [2] - MannKind has surpassed consensus revenue estimates three times over the last four quarters [2] 分组2 - The stock has underperformed, losing about 12.1% since the beginning of the year, while the S&P 500 gained 1.3% [3] - The current consensus EPS estimate for the coming quarter is $0.03 on revenues of $75.11 million, and for the current fiscal year, it is $0.23 on revenues of $329.64 million [7] - The Medical - Biomedical and Genetics industry is currently in the top 24% of Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Performance - The company reported a net income of $27.6 million for the year ended December 31, 2024, compared to net losses of $11.9 million and $87.4 million for the years ended December 31, 2023 and 2022, respectively[305]. - Total revenues for the year ended December 31, 2024, increased by $86.5 million, or 43%, to $285.5 million compared to $199.0 million in 2023[328]. - Commercial product sales rose by $8.3 million, or 11%, to $82.3 million for the year ended December 31, 2024, driven by an increase in Afrezza sales[328]. - Gross revenue from Afrezza sales increased by $11.0 million, or 13%, for the year ended December 31, 2024, primarily due to higher demand and price[328]. - Net revenue from collaborations and services surged by $47.9 million, or 90%, for the year ended December 31, 2024, attributed to increased manufacturing volume for products sold to UT[330]. - Commercial product gross profit increased by $11.7 million, or 22%, to $64.9 million for the year ended December 31, 2024, with a gross margin of 79%[334]. - For the year ended December 31, 2024, the company reported a GAAP net income of $27.6 million, translating to a basic EPS of $0.10, compared to a net loss of $11.9 million and an EPS of $(0.04) in 2023[349]. - Non-GAAP adjusted net income for 2024 was $67.7 million, with an adjusted EPS of $0.25, significantly up from an adjusted net income of $5.9 million and an EPS of $0.03 in 2023[349]. Cash and Liquidity - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $202.7 million, with an accumulated deficit of $3.2 billion and a total stockholders' deficit of $78.8 million[305]. - The company generated $42.5 million in cash from operating activities in 2024, primarily from $261.2 million in cash receipts from customers[358]. - The company expects to meet its liquidity needs over the next 12 months based on current cash resources and projected sales from its product pipeline, including Afrezza and V-Go[352]. - Total material cash requirements as of December 31, 2024, are projected to be $338.1 million, including $220.1 million for financing liabilities and $57.2 million for insulin purchase agreements[352]. - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $202.7 million, consisting of $46.3 million in cash and cash equivalents, $150.9 million in short-term investments, and $5.5 million in long-term investments[364]. Expenses and Costs - Research and development expenses rose by $14.6 million, or 47%, for the year ended December 31, 2024, primarily due to increased expenditures for clinical studies and personnel costs[336]. - Total expenses increased by $22.6 million, or 12%, to $212.9 million for the year ended December 31, 2024, driven by higher costs in collaborations and services[335]. - Cash used in investing activities for 2024 was $96.6 million, primarily due to the purchase of $273.8 million in held-to-maturity securities[360]. - Cash used in financing activities for 2024 amounted to $137.3 million, mainly for principal payments on senior convertible notes and other financing liabilities[362]. Clinical Studies and Product Development - The company initiated a Phase 3 clinical study of MNKD-101 in June 2024, with enrollment expected to continue into 2026[302]. - The Phase 1 clinical study of MNKD-201 conducted in 2024 met its primary objective, demonstrating positive safety results and good tolerability[303]. - The company anticipates continued expenditures for manufacturing operations, sales and marketing, and development costs for its product pipeline in the foreseeable future[364]. Royalties and Revenue Streams - The company receives a 10% royalty on net sales of Tyvaso DPI, which is subject to a 1% royalty sale to a purchaser, resulting in a net royalty of 9%[326]. - The company’s royalty revenue reflects an upward trend in demand for Tyvaso DPI in the marketplace[326]. - The reserves for variable consideration related to commercial products were 40% of gross product revenue, amounting to $53.8 million for the year ended December 31, 2024, down from 43% or $56.4 million in 2023[315]. Gains and Losses - The company reported a gain on bargain purchase of $5.3 million for the year ended December 31, 2024, resulting from the Pulmatrix Transaction[343]. - Loss on settlement of debt amounted to $20.4 million for the year ended December 31, 2024, due to repayment of senior convertible notes and early extinguishment of debt[344]. - For the year ended December 31, 2024, the company realized a $3.9 million currency gain from foreign currency transactions[369]. - A hypothetical 10% change in the U.S. dollar to Euro exchange rate would have impacted pre-tax income by approximately $5.8 million[370]. Debt and Financing - The senior convertible notes have a fixed interest rate of 2.50%, ensuring stable interest expenses without exposure to market rate changes[367]. - The MidCap credit facility had an interest rate capped at 8.25% or one month SOFR plus 6.25%, with repayment completed in April 2024[368]. - The company has a remaining obligation of $50.0 million under the Milestone Rights Agreement as of December 31, 2024, contingent on achieving specified strategic and sales milestones[355].

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]

Conference call to provide corporate updates today at 4:30 pm ET2024 revenues of $286M, +43% v. 2023; 4Q 2024 revenues of $77M, +31% v. 4Q 20232024 net income of $28M; Non-GAAP net income of $68M 4Q 2024 net income of $7M; Non-GAAP net income of $23MReduced debt principal by $236M; remaining convertible debt of $36MYear-end 2024 cash, cash equivalents and investments of $203MAdvanced pipeline: Reported primary endpoint of INHALE-1 for Afrezza in pediatricsProgressed MNKD-101 to Global Phase 3Completed Phase ...