Financial Performance - MannKind Corporation reported a record revenue quarter of $82 million[13] - Tyvaso DPI-related revenue reached $59 million in Q3 2025, a 15% increase from Q3 2024[13, 22] - Afrezza net revenue for Q3 2025 was $18.5 million, up 23% from Q3 2024[32] - FUROSCIX net revenue for Q3 2025 was $19.3 million, a 93% increase from Q3 2024[37] - Total revenue increased by 17% from Q3 2024 to Q3 2025[50] Product & Clinical Development - Afrezza sBLA was accepted for review, potentially becoming the first new insulin for pediatrics in over 100 years[13, 62] - FUROSCIX doses dispensed in Q3 2025 increased by 153% from Q3 2024[34] - The ICoN-1 global Phase 3 study achieved its interim enrollment target ahead of schedule[69] - INFLO Nintedanib DPI Phase 2 study was initiated, with the first patient expected to enroll in Q1 2026[15, 77] Market Opportunity - The addressable opportunity for heart failure (HF) is greater than $10 billion[39]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) Delaware 13-3607736 (State or other jurisdiction of incorporation or organization) 1 Casper Street Danbury, Connecticut 06810 (Address of principal executive offices) (Zip Code) 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, 2025 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Revenue Performance - Q3 2025 revenues reached $82.1 million, a 17% increase compared to Q3 2024[4] - Year-to-date 2025 revenues totaled $237.0 million, reflecting a 14% increase versus the same period in 2024[10] - Afrezza's revenue for Q3 2025 was $18.5 million, up 23% from $15.0 million in Q3 2024[9] - Total revenues for the three months ended September 30, 2025, were $82.13 million, a 17.2% increase from $70.08 million in the same period of 2024[23] - Commercial product sales reached $22.31 million for the three months ended September 30, 2025, compared to $19.73 million in 2024, reflecting a 13.1% growth[23] Expenses - Research and development expenses increased by $1.1 million, or 9%, in Q3 2025 compared to the prior year[8] - Selling, general and administrative expenses rose by $5.2 million, or 22%, in Q3 2025 due to higher headcount and acquisition-related costs[12] - Research and development expenses for the three months ended September 30, 2025, were $14.06 million, an increase from $12.93 million in 2024, reflecting a 8.8% rise[23] - The company incurred acquisition-related expenses of $3.67 million during the three months ended September 30, 2025, associated with the acquisition of scPharma[29] Net Income - Net income for Q3 2025 was $8.0 million, down from $11.6 million in Q3 2024[12] - Non-GAAP net income for Q3 2025 increased by 45% to $22.4 million compared to $15.4 million in Q3 2024[12] - Net income for the three months ended September 30, 2025, was $7.99 million, down from $11.55 million in 2024, representing a 30.5% decrease[23] - Non-GAAP net income for the three months ended September 30, 2025, was $22.45 million, compared to $15.35 million in 2024, a 46.5% increase[28] - The company reported a basic net income per share of $0.03 for the three months ended September 30, 2025, down from $0.04 in 2024[23] Assets and Liabilities - Cash, cash equivalents, and investments totaled $286.3 million as of September 30, 2025[9] - Cash and cash equivalents increased to $127.39 million as of September 30, 2025, from $46.34 million at the end of 2024[25] - Total assets rose to $494.64 million as of September 30, 2025, compared to $393.84 million at the end of 2024, marking a 25.6% increase[25] - Total liabilities increased to $539.19 million as of September 30, 2025, up from $472.66 million at the end of 2024, indicating a 14.0% rise[25] Acquisition - The acquisition of scPharmaceuticals was completed on October 7, 2025, expected to diversify and accelerate revenue growth[5] Regulatory Updates - The FDA accepted the sBLA for Afrezza in the pediatric population, with a PDUFA date set for May 29, 2026[3]

Core Insights - MannKind Corporation reported a 17% increase in Q3 2025 revenues to $82.1 million compared to Q3 2024, driven by higher royalties and product sales [6][9][14] - The acquisition of scPharmaceuticals is expected to enhance MannKind's commercial capabilities and accelerate revenue growth [2][7] - The FDA has accepted the sBLA for Afrezza in the pediatric population, with a PDUFA date set for May 29, 2026 [6][7] Financial Performance - Q3 2025 revenues reached $82.1 million, a $12.1 million increase from Q3 2024, with royalties up 23% to $33.3 million and Afrezza sales up 23% to $18.5 million [9][12] - Year-to-date revenues for 2025 totaled $237.0 million, reflecting a 14% increase compared to the same period in 2024 [14] - The company reported a net income of $8.0 million for Q3 2025, down from $11.6 million in Q3 2024, while non-GAAP net income increased by 45% to $22.4 million [16][23] Business Developments - The acquisition of scPharmaceuticals was completed on October 7, 2025, which is anticipated to diversify and accelerate revenue growth, particularly through the FUROSCIX product [6][7] - The company initiated a Phase 2 clinical trial for MNKD-201 in idiopathic pulmonary fibrosis (IPF) and plans to enroll the first patient in Q1 2026 [5][6] - MannKind's MNKD-101 Phase 3 trial achieved interim enrollment targets ahead of schedule, with an interim analysis expected mid-year 2026 [6][7] Research and Development - Research and development expenses increased by 9% in Q3 2025, primarily due to ongoing clinical trials and patient enrollment [12][17] - The company is advancing its investigational molecule under collaboration with United Therapeutics and has planned pre-clinical studies for Bumetanide DPI [11][17] Cash and Investments - As of September 30, 2025, MannKind had cash, cash equivalents, and investments totaling $286.3 million, with significant cash utilized for the acquisition of scPharmaceuticals [11][12] - The company reported an impairment of available-for-sale investment of $6.4 million for Q3 2025 due to the write-off of the Thirona investment [16][23]

Core Viewpoint - MannKind Corporation is set to release its third quarter 2025 financial results on November 5, 2025, before market opening [1] Group 1: Financial Results Announcement - The financial results will be discussed in a webcast starting at 9 a.m. Eastern Time on the same day [2] - The webcast will be available on MannKind's investor relations website, with a replay accessible for approximately 90 days [2] Group 2: Company Overview - MannKind Corporation is a biopharmaceutical company focused on innovative solutions for chronic disease care, particularly in cardiometabolic and orphan lung diseases [3] - The company develops treatments for serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease [3] - MannKind specializes in drug-device combinations to create therapies that integrate seamlessly into patients' daily lives [4]

Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3]. Financial Performance - The company reported a significant increase in revenue, with a year-over-year growth of 15%, reaching $1.5 billion in the last quarter [2]. - Operating income also saw a rise, up by 10% to $300 million, indicating improved operational efficiency [2]. Market Position - The company has strengthened its market share, now holding 25% of the industry, which is a 5% increase from the previous year [2]. - Competitive analysis shows that the company is outperforming its main rivals, which have only seen a 3% growth in the same period [2]. Future Outlook - Analysts predict continued growth for the company, with expectations of a 12% increase in revenue for the next fiscal year, driven by new product launches and market expansion [2]. - The company is also exploring strategic partnerships to enhance its service offerings and reach new customer segments [2].

Core Viewpoint - The article emphasizes the importance of conducting independent research and due diligence before making investment decisions, highlighting the inherent risks and volatility associated with stock investments [2][3]. Group 1 - The article provides informational content but does not serve as an exhaustive analysis of any featured company [2]. - It clarifies that the predictions and opinions presented are based on a probabilistic approach rather than absolute certainty [2]. - The author has no stock or derivative positions in any mentioned companies and does not plan to initiate any within the next 72 hours [1]. Group 2 - The article stresses that past performance is not indicative of future results, and no specific investment recommendations are provided [3]. - It notes that the views expressed may not reflect those of the broader platform, Seeking Alpha, as the analysts are third-party authors with varying levels of expertise [3]. - Readers are encouraged to verify the information independently and assess their financial circumstances before making investment decisions [2].

Core Insights - MannKind Corporation announced that the FDA has accepted the supplemental biologics license application (sBLA) for Afrezza, seeking approval for use in children and adolescents with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026 [1][8] Company Overview - MannKind Corporation is a biopharmaceutical company focused on innovative solutions for chronic diseases, particularly in cardiometabolic and orphan lung diseases, including diabetes [6][7] Product Information - Afrezza is a rapid-acting inhaled human insulin indicated for improving glycemic control in adults with diabetes mellitus, and it has been available for adults since June 2014 [3][4] - If approved for pediatric use, Afrezza would be the first needle-free insulin option for children in over 100 years [8] Clinical Study Details - The sBLA is based on the Phase 3 INHALE-1 study, which involved children and adolescents aged 4-17, comparing Afrezza with multiple daily injections (MDI) [2][8] - The study's six-month topline results were reported in December 2024, and full results will be presented at the International Society for Pediatric and Adolescent Diabetes (ISPAD) in early November [2]

Core Insights - MannKind Corporation has successfully completed the acquisition of scPharmaceuticals Inc, which is expected to diversify and accelerate its revenue growth, particularly through the innovative therapy FUROSCIX for edema related to chronic heart failure and chronic kidney disease [1][2] - The acquisition enhances MannKind's commercial and medical capabilities by integrating scPharmaceuticals' experienced team, positioning the company for further growth in cardiometabolic care [2] - MannKind's annualized revenue run rate exceeds $370 million based on Q2 2025 results, driven by its commercial assets including Afrezza, FUROSCIX, and V-Go [1] Acquisition Details - The acquisition was structured as a tender offer at a price of $5.35 per share in cash, plus a non-tradable contingent value right (CVR) for potential milestone payments, totaling up to $6.35 per share [3] - Approximately 73.47% of scPharmaceuticals' outstanding shares were tendered, allowing the transaction to proceed, with scPharmaceuticals becoming a wholly owned subsidiary of MannKind [4] - Following the acquisition, scPharmaceuticals' common stock ceased trading on Nasdaq [5] Strategic Fit and Future Growth - The strategic alignment between MannKind and scPharmaceuticals creates significant growth opportunities by combining MannKind's endocrinology expertise with scPharmaceuticals' cardiovascular capabilities [2] - MannKind aims to expand FUROSCIX's market reach among nephrologists and cardiologists, enhancing its position in chronic heart failure treatment [2] - The company has a late-stage pipeline that includes Inhaled Clofazimine and nintedanib DPI, which supports long-term value creation [2]

Core Insights - MannKind Corporation has successfully completed the acquisition of scPharmaceuticals Inc, which is expected to diversify and accelerate its revenue growth, particularly through the innovative therapy FUROSCIX® for edema related to chronic heart failure and chronic kidney disease [1][2] - The acquisition enhances MannKind's commercial and medical capabilities by integrating scPharmaceuticals' experienced team, positioning the company for further growth in cardiometabolic care [2] - MannKind's annualized revenue run rate exceeds $370 million based on Q2 2025 results, supported by its commercial assets including Afrezza®, FUROSCIX®, and V-Go® [1] Acquisition Details - The acquisition was structured as a tender offer at a price of $5.35 per share in cash, plus a non-tradable contingent value right (CVR) for potential milestone payments, totaling up to $6.35 per share [3] - Approximately 73.47% of scPharmaceuticals' outstanding shares were tendered, allowing the transaction to proceed, with scPharmaceuticals becoming a wholly owned subsidiary of MannKind [4] - Following the acquisition, scPharmaceuticals' common stock ceased trading on Nasdaq [5] Strategic Fit and Future Growth - The strategic alignment between MannKind and scPharmaceuticals creates significant growth opportunities by combining MannKind's endocrinology expertise with scPharmaceuticals' cardiovascular capabilities [2] - MannKind aims to expand FUROSCIX's market reach among nephrologists and cardiologists, enhancing its position in chronic heart failure treatment [2] - The company has a late-stage pipeline that includes Inhaled Clofazimine and nintedanib DPI, which supports long-term value creation [2]