MannKind Reports Second Quarter 2026 Financial Results and Provides Business Update

• 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

• 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

• 1 in 3 of the top 100 pediatric insulin writers have prescribed

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.”

• Revenue from marketed products (Afrezza, Furoscix ®) grew 27% from Q1 2026 to Q2 2026

• 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 (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

• 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

• 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

• 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

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.

• 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.

• 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).

• 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.

• 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.

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.

• 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.

• 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).

• 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.

• 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 https://investors.mannkindcorp.com/events-and-presentations. 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.

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: