Insulin Recombinant Human(MannKind)

Conference call today at 9:00 am ET Q4 2025 revenues of $112M, +46% vs. Q4 2024 Furoscix ® Q4 2025 net sales of $23M, +91% vs. Q4 2024 Afrezza ® Q4 2025 net sales of $23M, +25% vs. Q4 2024 2025 full year revenues of $349M, +22% vs. 2024 Successfully completed the acquisition of scPharmaceuticals Inc. (scPharma) Program updates: Afrezza pediatric indication PDUFA date May 29, 2026 Furoscix ReadyFlow ™  Autoinjector PDUFA date July 26, 2026 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today reported financial results for the fourth quarter and year ended December 31, 2025, and provided a business update. “MannKind closed 2025 with strong momentum across our commercial portfolio and meaningful progress in our pipeline. The addition of Furoscix strengthens our cardiometabolic franchise, while Afrezza and UT-related revenues continue to deliver sustained growth,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “As we enter a catalyst‑rich 2026, with two upcoming FDA decisions, and Nintedanib DPI INFLO-1 Phase 1b topline data, we believe we are well‑positioned to drive long‑term value for patients, providers and shareholders. Our team’s hard work over the last several years is culminating in significant milestones with the potential to drive near-term growth.” Business Update and Upcoming Milestones Commercial Products Furoscix Furoscix (furosemide injection) generated $23 million in net sales following the October 7, 2025, acquisition, compared to $12 million in Q4 2024 as reported by scPharma, a 91% increase FDA accepted for review a supplemental New Drug Application (sNDA) for Furoscix ReadyFlow Autoinjector; with a PDUFA target action date of July 26, 2026; if approved, it would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds Afrezza Afrezza (insulin human) Inhalation Powder Q4 2025 net sales were $23 million, compared to $18 million in Q4 2024, a 25% increase FDA accepted for review the supplemental Biologics License Application (sBLA) for Afrezza in pediatrics, with a PDUFA target action date of May 29, 2026; if approved, it would be the first needle-free insulin option for pediatric patients In Q1 2026, the FDA approved updated Afrezza label providing starting dose guidance when switching from multiple daily injections (MDI) or insulin pump mealtime therapy ADA Standards of Care in Diabetes – 2026 now recommends clinicians evaluate inhaled insulin as a prandial option at every patient visit, moving it into routine care conversations and creating a catalyst for broader adoption Afrezza launched in India by Cipla Development Nintedanib DPI (MNKD-201) Enrollment underway in Phase 1b (INFLO-1) study, top line data expected in 2H 2026 Initiated Phase 2 clinical trial (INFLO-2) in idiopathic pulmonary fibrosis (IPF) and plan to enroll first patient in Q2 2026 Other Programs Formulating investigational molecule (MNKD-1501) under the expanded collaboration with United Therapeutics (UT) using MannKind’s proprietary Technosphere® platform Initiated pre-clinical development of Bumetanide DPI (MNKD-701) Corporate Update Completed acquisition of scPharma on October 7, 2025 Cash, cash equivalents and investments as of December 31, 2025, totaled $176 million Fourth Quarter and Full Year 2025 Financial Results Revenues Three Months Ended December 31, 2025 2024 $ Change % Change Revenues (Dollars in thousands) Royalties $ 33,564 $ 27,009 $ 6,555 24 % Collaborations and services 27,986 26,710 1,276 5 % Afrezza 22,878 18,279 4,599 25 % Furoscix (1) 23,178 — 23,178 N/A V-Go 4,349 4,778 (429 ) (9 %) Total revenues $ 111,955 $ 76,776 $ 35,179 46 % (1) Amount represents revenue earned beginning on the scPharma acquisition date of October 7, 2025. Year Ended December 31, 2025 2024 $ Change % Change Revenues (Dollars in thousands) Royalties $ 128,116 $ 102,335 $ 25,781 25 % Collaborations and services 106,713 100,840 5,873 6 % Afrezza 74,587 64,041 10,546 16 % Furoscix (1) 23,178 — 23,178 N/A V-Go 16,372 18,288 (1,916 ) (10 %) Total revenues $ 348,966 $ 285,504 $ 63,462 22 % (1) Amount represents revenue earned beginning on the scPharma acquisition date of October 7, 2025. Total revenues for the fourth quarter and full year 2025 rose due to increases in revenue from royalties, collaborations and services, and commercial product sales. The increase in royalties was due to UT’s increase in net revenue from sales of Tyvaso DPI ® . Collaborations and services revenue grew due to increased units sold to UT. Revenue from commercial sales increased primarily due to net sales from Furoscix beginning on the scPharma acquisition date of October 7, 2025 as well as an increase in net sales of Afrezza over the prior periods. Operating Expenses and Other Financial Highlights Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was $13.9 million for the fourth quarter of 2025, compared to $4.8 million for the same period in 2024, an increase of 190%. For the full year 2025, Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was $26.8 million, compared to $17.4 million for the same period in 2024, an increase of 54%. These increases are primarily attributable to the inclusion of Furoscix following the acquisition on October 7, 2025, as well as increased sales of Afrezza. Cost of revenue – collaborations and services was $15.7 million for the fourth quarter of 2025, compared to $14.8 million for the same period in 2024, an increase of 6%. For the full year 2025, cost of revenue – collaborations and services was $61.2 million, compared to $59.2 million for the same period in 2024, an increase of 3%. These increases are primarily the result of a higher number of units of Tyvaso DPI sold through to UT compared to the prior periods. Research and development ("R&D") expenses were $27.6 million for the fourth quarter of 2025 compared to $11.1 million for the same period in 2024, an increase of 148%. For the full year 2025, R&D expenses were $66.3 million compared to $45.9 million in the same period in 2024, an increase of 45%. These increases were primarily attributable to the ICoN-1 clinical study for MNKD-101, which was discontinued in the fourth quarter of 2025, clinical production scale-up for MNKD-201, personnel costs primarily due to a full-year of costs associated with the third quarter of 2024 Pulmatrix transaction, which bolstered our research capabilities and capacity, and ReadyFlow Autoinjector-related expenses. These increases were partially offset by the completion of INHALE-3, the Phase 1 clinical study for MNKD-201, and toxicology studies in 2024, as well as lower costs for INHALE-1 as the study was closed out in the second quarter of 2025. Selling, general and administrative ("SG&A") expenses were $58.4 million for the fourth quarter of 2025 compared to $24.0 million for the same period in 2024, an increase of 144%. For the full year 2025, SG&A expenses were $144.1 million compared to $94.3 million in the same period in 2024, an increase of 53%. These increases primarily reflect the inclusion of SG&A costs associated with the promotion and support of Furoscix as well as transaction-related costs incurred as part of the acquisition of scPharma. The remainder of the increase was largely attributable to higher headcount and personnel-related expenses in our commercial group as well as increased promotional costs in preparation to support the potential pediatric launch of Afrezza in 2026. Conference Call MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. The webcast will be accessible via a link on MannKind’s website. A replay will also be available in the same location within 24 hours after the call and accessible for approximately 90 days. About MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com. Forward-Looking Statements Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding MannKind's expectations about 2026 being a catalyst-rich year; the FDA’s potential approval of the sBLA for Afrezza for the pediatric population and of the sNDA for Furoscix ReadyFlow Autoinjector, and the expected timing thereof; expectations regarding MannKind’s ongoing and planned clinical trials and nonclinical studies, including the timing for enrollment for the Phase 2 clinical trial of MNKD-201 in IPF and the expected timing for data readouts from the Phase 1b clinical trial of MNKD-201, and preclinical development of MNKD-701; the potential benefits of Furoscix ReadyFlow Autoinjector and Afrezza Inhalation Powder in pediatrics, if approved; the ADA’s Standards of Care in Diabetes 2026 recommendations for inhaled insulin creating a catalyst for broader adoption; and MannKind being positioned to drive long-term value. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trials and reporting data; risks associated with safety and other complications of our products and product candidates; risks associated with the regulatory review process; risks associated with competition; manufacturing risks; market adoption risks; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2025, being filed with the SEC later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. Tyvaso DPI is a trademark of United Therapeutics Corporation. Furoscix is a registered trademark and Furoscix ReadyFlow is a trademark of scPharmaceuticals Inc., a subsidiary of MannKind Corporation. AFREZZA, MANNKIND, TECHNOSPHERE and V-GO are registered trademarks of MannKind Corporation. MannKind Contacts: Investor Relations Kate Miranda (617) 921-5461 Email: ir@mnkd.com Media Relations Christie Iacangelo (818) 292-3500 Email: media@mnkd.com MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 (In thousands except per share data) Revenues: Commercial product sales $ 50,405 $ 23,057 $ 114,137 $ 82,329 Collaborations and services 27,986 26,710 106,713 100,840 Royalties 33,564 27,009 128,116 102,335 Total revenues 111,955 76,776 348,966 285,504 Expenses: Cost of goods sold – commercial, excluding amortization of acquired intangible assets 13,927 4,808 26,800 17,429 Cost of revenue – collaborations and services 15,746 14,796 61,160 59,173 Research and development 27,588 11,138 66,348 45,893 Selling, general and administrative 58,411 23,972 144,135 94,329 Amortization of acquired intangible assets 3,973 — 3,973 — (Gain) loss on foreign currency transaction (3 ) (4,433 ) 7,749 (3,907 ) Total expenses 119,642 50,281 310,165 212,917 (Loss) income from operations (7,687 ) 26,495 38,801 72,587 Other income (expense): Interest income, net 1,637 2,825 8,053 12,615 Interest expense on liability for sale of future royalties (3,885 ) (3,452 ) (14,449 ) (16,172 ) Interest expense on financing liability (2,451 ) (2,467 ) (9,750 ) (9,828 ) Impairment of available-for-sale investment — — (6,409 ) (1,550 ) Interest expense (7,536 ) (1,562 ) (13,830 ) (11,981 ) Other (expense) income (1,009 ) — (1,009 ) 32 Gain on bargain purchase — — — 5,259 Loss on settlement of debt — (13,394 ) — (20,444 ) Total other expense (13,244 ) (18,050 ) (37,394 ) (42,069 ) Income before income tax (benefit) expense (20,931 ) 8,445 1,407 30,518 Income tax (benefit) expense (4,983 ) 1,023 (4,456 ) 2,930 Net (loss) income $ (15,948 ) $ 7,422 $ 5,863 $ 27,588 Net (loss) income per share – basic $ (0.05 ) $ 0.03 $ 0.02 $ 0.10 Weighted average shares used to compute net (loss) income per share – basic 307,260 279,191 305,639 274,415 Net (loss) income per share – diluted $ (0.05 ) $ 0.03 $ 0.02 $ 0.10 Weighted average shares used to compute net (loss) income per share – diluted (1) 307,260 290,631 314,112 283,844 (1) Diluted weighted average shares ("DWAS") differs from basic weighted average shares due to the weighted average number of shares that would be outstanding upon exercise or vesting of outstanding share-based payments to employees and conversion of convertible notes. For the year ended December 31, 2025, DWAS included 8.5 million shares issuable upon exercise or vesting of outstanding share-based payments. MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS December 31, 2025 December 31, 2024 (In thousands except share and per share data) ASSETS Current assets: Cash and cash equivalents $ 74,882 $ 46,339 Short-term investments 96,464 150,917 Accounts receivable, net 38,367 11,804 Inventory 35,313 27,886 Prepaid expenses and other current assets 46,553 31,360 Total current assets 291,579 268,306 Restricted cash 745 737 Long-term investments 5,012 5,482 Property and equipment, net 82,423 85,365 Goodwill 67,595 1,931 Developed technology - on-body infusor 190,027 — IPR&D - ReadyFlow Formulation 129,600 — Other intangible assets 5,072 5,265 Other assets 20,129 26,757 Total assets $ 792,182 $ 393,843 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 9,034 $ 6,792 Accrued expenses and other current liabilities 64,628 40,293 Senior convertible notes – current 36,280 — Liability for sale of future royalties – current 14,298 12,283 Contingent consideration - current 21,132 — Financing liability – current 10,328 10,062 Deferred revenue – current 15,331 12,407 Total current liabilities 171,031 81,837 Liability for sale of future royalties – long term 136,985 137,362 Financing liability – long term 93,092 93,877 Deferred revenue – long term 39,977 51,160 Recognized loss on purchase commitments – long term 65,952 58,204 Operating lease liability 10,689 11,645 Contingent consideration -long term 5,114 — Milestone liabilities 2,003 2,523 Term loan 318,361 — Senior convertible notes — 36,051 Total liabilities 843,204 472,659 Commitments and contingencies Stockholders' deficit: Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized; — — no shares issued or outstanding as of December 31, 2025 or December 31, 2024 Common stock, $0.01 par value – 800,000,000 shares authorized; 3,078 3,029 307,832,587 and 302,959,782 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively Additional paid-in capital 3,141,741 3,118,865 Accumulated other comprehensive income 115 1,109 Accumulated deficit (3,195,956 ) (3,201,819 ) Total stockholders' deficit (51,022 ) (78,816 ) Total liabilities and stockholders' deficit $ 792,182 $ 393,843 Non-GAAP Measures To supplement our consolidated financial statements presented under GAAP, we are presenting non-GAAP net income (loss) and non- GAAP net income (loss) per share - basic, which are non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non- GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. The following table reconciles our financial measures for net income (loss) and net income (loss) per share ("EPS") for basic weighted average shares as reported in our consolidated statement of operations to a non-GAAP presentation: Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Net Income Basic EPS Net Income Basic EPS Net Income Basic EPS Net Income (Loss) Basic EPS (In thousands except per share data) GAAP reported net (loss) income $ (15,948 ) $ (0.05 ) $ 7,422 $ 0.03 $ 5,863 $ 0.02 $ 27,588 $ 0.10 Non-GAAP adjustments: Stock compensation 6,972 0.02 5,818 0.02 24,195 0.08 21,358 0.08 Interest expense on liability for sale of future royalties 3,885 0.01 3,452 0.01 14,449 0.05 16,172 0.06 Sold portion of royalty revenue (1) (3,357 ) (0.01 ) (2,701 ) (0.01 ) (12,812 ) (0.04 ) (10,234 ) (0.04 ) Acquisition-related expenses (2) 6,017 0.03 — — 9,690 0.03 — — Amortization of intangible assets acquired 3,973 0.01 — — 3,973 0.01 — — (Gain) loss on foreign currency transaction (3 ) — (4,433 ) (0.02 ) 7,749 0.03 (3,907 ) (0.01 ) Impairment loss on available-for-sale investment — — — — 6,409 0.01 1,550 0.01 Gain on bargain purchase — — — — — — (5,259 ) (0.02 ) Loss on settlement of debt — — 13,394 0.05 — — 20,444 0.07 Non-GAAP adjusted net income (loss) $ 1,539 $ 0.01 $ 22,952 $ 0.08 $ 59,516 $ 0.19 $ 67,712 $ 0.25 Weighted average shares used to compute net income (loss) per share – basic 307,260 279,191 305,639 274,415 (1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the years ended December 31, 2025 and 2024 which is remitted to the royalty purchaser and recognized as royalties from collaborations in our consolidated statements of operations. Our revenues from royalties from collaborations during the year ended December 31, 2025 and 2024 totaled $128.1 million and $102.3 million, respectively, of which $12.8 million and $10.2 million, respectively, is remitted to the royalty purchaser. (2) Represents transaction fees incurred during the year ended December 31, 2025 associated with the acquisition of scPharma.