Core Insights - MannKind (MNKD) reported $76.78 million in revenue for Q4 2024, a year-over-year increase of 31.3% and a surprise of +1.48% over the Zacks Consensus Estimate of $75.66 million [1] - The company achieved an EPS of $0.03, which is consistent with the consensus estimate and compares to $0.02 a year ago [1] Revenue Breakdown - Royalties and collaborations revenue was $27.01 million, exceeding the estimated $26.10 million, representing a +28.4% change year-over-year [4] - Revenue from collaborations and services was $26.71 million, slightly below the estimated $27.07 million, but showing a significant year-over-year increase of +54.9% [4] - Net revenue from commercial product sales reached $23.06 million, surpassing the estimated $21.63 million, with a year-over-year growth of +14.2% [4] Stock Performance - MannKind's shares have returned -7.5% over the past month, compared to a -2.3% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

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 ...

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]

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 ...