Insulin Recombinant Human(MannKind)

Achieved three major catalysts to drive future growth: Launched the pediatric indication of Afrezza ® following FDA approval FUROSCIX ReadyFlow™ autoinjector approved for treatment of edema in HF and CKD Positive nintedanib DPI Phase 1b data in IPF patients validates continued Phase 2 advancement Encouraging early momentum in Afrezza pediatric launch 1 in 3 of the top 100 pediatric insulin writers have prescribed Q2 2026 total revenues of $109.4M, +43% vs. Q2 2025 Conference call and webcast today at 4:30 p.m. ET DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 05, 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 second quarter of 2026, and provided a business update. “This was a transformative period for MannKind, during which we delivered all three major catalysts we set out to achieve in 2026,” said Michael Castagna, Chief Executive Officer of MannKind. “The two recent FDA approvals are expected to fuel our near-term growth opportunities to help patients living with diabetes, heart failure and CKD. The positive Phase 1b INFLO-1 results for MNKD-201 reduces development risk and strengthens our confidence in the ability of our platform to help people living with IPF and other fibrotic diseases. Together, these milestones validate our diversification strategy and position MannKind for sustainable growth.” Business Update and Upcoming Milestones Commercial Products Revenue from marketed products (Afrezza, Furoscix ® ) grew 27% from Q1 2026 to Q2 2026 Furoscix ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Furoscix (furosemide injection) generated $22.2 million in net sales for Q2 2026 Continued growth in Integrated Delivery Networks, increasing doses purchased by 36% over Q1 2026 Record number of nephrology units dispensed, increasing by 67% over Q1 2026 Received FDA approval of Furoscix ReadyFlow™ on July 23, 2026, the first and only autoinjector delivering IV-equivalent diuretic therapy for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD); expected to be commercially available in late August Afrezza Afrezza (insulin human) Inhalation Powder generated $17.0 million in net sales for Q2 2026 Received FDA approval of Afrezza on May 29, 2026 for use in children and adolescents ages 6 and older living with diabetes Awarded Breakthrough T1D grant supporting advancement of INHALE-1 ST , a pediatric trial of Afrezza in youth with newly diagnosed type 1 diabetes Development Nintedanib DPI (MNKD-201) Topline data readout of U.S. Phase 1b INFLO-1 demonstrates safety and tolerability in IPF patients Site activation and enrollment underway in the global Phase 2 INFLO-2 study Ralinepag DPI (MNKD-1501) On track for IND filing by year end Received a $5 million payment from United Therapeutics (UT) to support the rapid advancement of ralinepag DPI Corporate Update Cash, cash equivalents and investments as of June 30, 2026, totaled $111 million Closed $50 million private placement on July 24, 2026; proceeds will fund the $45 million CVR payment triggered by the FDA approval of Furoscix ReadyFlow Second Quarter 2026 Financial Results Revenues Three Months Ended June 30, 2026 2025 $ Change % Change Revenues (Dollars in thousands) Afrezza 17,021 18,329 (1,308 ) (7 %) Furoscix 22,191 — 22,191 N/A V-Go ® 2,770 4,125 (1,355 ) (33 %) Collaborations and services 35,022 22,845 12,177 53 % Royalties 32,370 31,228 1,142 4 % Total revenues $ 109,374 $ 76,527 $ 32,847 43 % Total revenues for the second quarter of 2026 increased compared to the same period in the prior year due to the addition of Furoscix to our product portfolio through the October 7, 2025 acquisition of scPharma, as well as increases in collaborations and services revenue, and royalties. The increase in collaborations and services revenue was primarily attributable to increased product sold to UT and revenue earned related to the development of ralinepag DPI. The increase in royalties was due to UT’s increase in net revenue from sales of Tyvaso DPI. Operating Expenses and Other Financial Highlights Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was $14.4 million for the three months ended June 30, 2026, compared to $4.6 million for the same period in 2025. The increase is primarily attributable to the inclusion of Furoscix into our product portfolio following the acquisition of scPharma in October 2025. Gross margin percentage decreased in the current period due to the inclusion of Furoscix, which has a lower gross margin percentage than Afrezza. Research and development expenses were $18.0 million for the three months ended June 30, 2026, compared to $13.7 million for the same period in 2025, an increase of 32%. The increase was primarily attributable to the development of the Furoscix ReadyFlow Formulation as well as higher personnel costs following the acquisition of scPharma and increased development costs for MNKD-201, which has begun enrolling subjects. The increase was partially offset by lower clinical development expenses resulting from the discontinuation of the ICoN-1 clinical study for MNKD-101 and the completion of the Afrezza pediatric study (INHALE-1). Selling, general and administrative expenses were $58.3 million for the three months ended June 30, 2026, compared to $31.6 million for the same period in 2025, an increase of 84%. The increase was primarily related to costs associated with the promotion and support of Furoscix, as well as expanding our field-based teams and activities to support the launches associated with the recent approvals of the pediatric indication for Afrezza and the Furoscix ReadyFlow Autoinjector. Six Months Ended June 30, 2026 Revenues Six Months Ended June 30, 2026 2025 $ Change % Change Revenues (Dollars in thousands) Afrezza 32,294 33,216 (922 ) (3 %) Furoscix 37,684 — 37,684 N/A V-Go 5,911 8,211 (2,300 ) (28 %) Collaborations and services 58,536 52,221 6,315 12 % Royalties 65,119 61,233 3,886 6 % Total revenues $ 199,544 $ 154,881 $ 44,663 29 % Total revenues for the six months ended June 30, 2026 increased compared to the same period in the prior year due to the addition of Furoscix to our product portfolio through the October 7, 2025 acquisition of scPharma, as well as increases in collaborations and services revenue, and royalties. The increase in collaborations and services revenue was primarily attributable to an increase in revenue earned related to the development of ralinepag DPI. The increase in royalties was due to UT’s increase in net revenue from sales of Tyvaso DPI. Operating Expenses and Other Financial Highlights Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was $21.9 million for the six months ended June 30, 2026, compared to $8.4 million for the same period in 2025. The increase is primarily attributable to the inclusion of Furoscix into our product portfolio following the acquisition of scPharma in October 2025. Gross margin percentage decreased in the current period due to the inclusion of Furoscix, which has a lower gross margin percentage than Afrezza. Research and development expenses were $35.2 million for the six months ended June 30, 2026, compared to $24.7 million for the same period in 2025, an increase of 43%. The increase was primarily attributable to the development of the Furoscix ReadyFlow Formulation as well as higher personnel costs following the acquisition of scPharma and increased development costs for MNKD-201, which has begun enrolling subjects. The increase was partially offset by lower clinical development expenses resulting from the discontinuation of the ICoN-1 clinical study for MNKD-101 and the completion of the Afrezza pediatric study (INHALE-1). Selling, general and administrative expenses were $112.4 million for the six months ended June 30, 2026, compared to $56.6 million for the same period in 2025, an increase of 98%. The increase was primarily related to costs associated with the promotion and support of Furoscix, as well as expanding our field-based teams and activities to support the launches associated with the recent approvals of the pediatric indication for Afrezza and the Furoscix ReadyFlow Autoinjector. Conference Call and Webcast MannKind will host a conference call and webcast to discuss these results today at 4:30 p.m. Eastern Time. The webcast will be accessible via a link on MannKind’s website at . 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 the timing for expected commercial availability of Furoscix ReadyFlow and the broadened growth potential for Furoscix; the timing of a planned IND filing of ralinepag DPI; expectations regarding MannKind’s ongoing and planned clinical trials and nonclinical studies; and our being positioned for sustainable growth. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal,” “potential,” “prepare,” “opportunity” 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, 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. AFREZZA, FUROSCIX, FUROSCIX READYFLOW, MANNKIND, and V-GO are trademarks of MannKind Corporation. MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 (In thousands except per share data) Revenues: Commercial product sales $ 41,982 $ 22,454 $ 75,889 $ 41,427 Collaborations and services 35,022 22,845 58,536 52,221 Royalties 32,370 31,228 65,119 61,233 Total revenues 109,374 76,527 199,544 154,881 Expenses: Cost of goods sold – commercial, excluding amortization of acquired intangible assets 14,409 4,607 21,917 8,375 Cost of revenue – collaborations and services 15,131 15,961 25,094 29,709 Research and development 18,001 13,675 35,232 24,697 Selling, general and administrative 58,302 31,622 112,389 56,636 Amortization of acquired intangible assets 4,367 — 8,734 — (Gain) loss on foreign currency transaction (486 ) 5,363 (1,804 ) 7,872 Total expenses 109,724 71,228 201,562 127,289 (Loss) income from operations (350 ) 5,299 (2,018 ) 27,592 Other income (expense): Interest income, net 1,022 1,832 2,452 3,788 Interest expense (11,894 ) (285 ) (19,372 ) (4,930 ) Interest expense on liability for sale of future royalties (510 ) (3,473 ) (3,073 ) (7,050 ) Interest expense on financing liability (2,414 ) (2,433 ) (4,807 ) (4,843 ) Loss on settlement of debt — — (917 ) — Other expense (4,992 ) — (7,769 ) — Total other expense (18,788 ) (4,359 ) (33,486 ) (13,035 ) (Loss) income before income tax (benefit) expense (19,138 ) 940 (35,504 ) 14,557 Income tax (benefit) expense (106 ) 272 147 731 Net (loss) income $ (19,032 ) $ 668 $ (35,651 ) $ 13,826 Net (loss) income per share – basic $ (0.06 ) $ 0.00 $ (0.12 ) $ 0.05 Weighted average shares used to compute net (loss) income per share – basic 309,191 304,954 308,732 304,222 Net (loss) income per share – diluted $ (0.06 ) $ 0.00 $ (0.12 ) $ 0.04 Weighted average shares used to compute net (loss) income per share – diluted 309,191 311,484 308,732 312,381 MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS June 30, 2026 December 31, 2025 (In thousands except share and per share data) ASSETS Current assets: Cash and cash equivalents $ 52,929 $ 74,882 Short-term investments 58,201 96,464 Accounts receivable, net 43,207 38,367 Inventory 44,419 35,313 Prepaid expenses and other current assets 46,956 46,553 Total current assets 245,712 291,579 Restricted cash 749 745 Long-term investments — 5,012 Property and equipment, net 85,160 82,423 Goodwill 67,595 67,595 Developed technology - on-body infusor 181,389 190,027 IPR&D - ReadyFlow Formulation 129,600 129,600 Other intangible assets 4,976 5,072 Other assets 17,123 20,129 Total assets $ 732,304 $ 792,182 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 11,042 $ 9,034 Accrued expenses and other current liabilities 60,768 64,628 Senior convertible notes – current — 36,280 Liability for sale of future royalties – current 14,292 14,298 Contingent consideration – current 34,015 21,132 Financing liability – current 10,486 10,328 Deferred revenue – current 11,085 15,331 Recognized loss on purchase commitments – current 1,210 — Total current liabilities 142,898 171,031 Liability for sale of future royalties – long term 133,552 136,985 Financing liability – long term 92,497 93,092 Deferred revenue – long term 36,857 39,977 Recognized loss on purchase commitments – long term 62,922 65,952 Operating lease liability 9,687 10,689 Contingent consideration – long term — 5,114 Milestone liabilities 2,003 2,003 Term loan 319,085 318,361 Total liabilities 799,501 843,204 Commitments and contingencies Stockholders' deficit: Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2026 or December 31, 2025 — — Common stock, $0.01 par value – 800,000,000 shares authorized; 309,911,682 and 307,832,587 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 3,099 3,078 Additional paid-in capital 3,161,330 3,141,741 Accumulated other comprehensive (loss) income (19 ) 115 Accumulated deficit (3,231,607 ) (3,195,956 ) Total stockholders' deficit (67,197 ) (51,022 ) Total liabilities and stockholders' deficit $ 732,304 $ 792,182 Non-GAAP Measures To supplement our condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP net (loss) income and non-GAAP net (loss) income 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 condensed 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 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 (loss) income and net (loss) income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statement of operations to a non-GAAP presentation: Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Net Loss Basic EPS Net Income Basic EPS Net Loss Basic EPS Net Income Basic EPS GAAP reported net (loss) income $ (19,032 ) $ (0.06 ) $ 668 $ 0.00 $ (35,651 ) $ (0.12 ) $ 13,826 $ 0.05 Non-GAAP adjustments: Stock compensation 10,226 0.03 7,520 0.03 16,681 0.05 12,905 0.04 Interest expense on liability for sale of future royalties 510 0.00 3,473 0.01 3,073 0.01 7,050 0.02 Sold portion of royalty revenue (1) (3,237 ) (0.01 ) (3,123 ) (0.01 ) (6,512 ) (0.02 ) (6,123 ) (0.02 ) (Gain) loss on foreign currency transaction (486 ) 0.00 5,363 0.02 (1,804 ) (0.01 ) 7,872 0.03 Amortization of intangible assets acquired 4,367 0.01 — — 8,734 0.03 — — Change in fair value of contingent consideration 4,992 0.02 — — 7,769 0.03 — — Loss on settlement of debt — — — — 917 0.00 — — Non-GAAP adjusted net (loss) income $ (2,660 ) $ (0.01 ) $ 13,901 $ 0.05 $ (6,793 ) $ (0.03 ) $ 35,530 $ 0.12 Weighted average shares used to compute net (loss) income per share – basic 309,191 304,954 308,732 304,222 (1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and six months ended June 30, 2026 and 2025 which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. CONTACT: MannKind Contacts: Investor Relations Kate Miranda Email: ir@mnkd.com Media Relations Christie Iacangelo Email: media@mnkd.com