MannKind(MNKD) - 2025 Q2 - Quarterly Results

Executive Summary & Business Update MannKind's Q2 2025 update highlights pipeline advancements for Afrezza, MNKD-101, and MNKD-201, and strong revenue growth CEO Statement MannKind's CEO highlighted Afrezza sBLA submission, robust ICoN-1 enrollment, and planned MNKD-201 Phase 2 advancement * Submission of sBLA for Afrezza in pediatric patients is a meaningful milestone for MannKind and people living with diabetes[4] * Robust enrollment progress in the ICoN-1 trial of inhaled clofazimine (MNKD-101) for NTM lung disease[4] * Excited to advance nintedanib DPI (MNKD-201) into Phase 2 for IPF[4] 2Q 2025 Business Update and Upcoming Milestones MannKind updated on Afrezza sBLA, ahead-of-schedule MNKD-101 enrollment, and planned MNKD-201 Phase 2 initiation by year-end 2025 * Submitted an sBLA for Afrezza® in the pediatric population, with a review acceptance decision expected in early 4Q 2025; filing based on INHALE-1 study data[7][8] * MNKD-101 (Inhaled Clofazimine) Phase 3 global clinical trial (ICoN-1) enrollment is ahead of schedule; interim enrollment target of 100 patients expected in early 4Q 2025[5][7] * MNKD-201 (Nintedanib DPI) Phase 2 clinical trial for IPF expected to initiate by YE 2025[6][7] 2Q 2025 Financial Highlights MannKind reported a 6% increase in Q2 2025 total revenues to $76.5 million, and 12% year-to-date to $154.9 million | Metric | 2Q 2025 | 2Q 2024 | Change ($) | Change (%) | | :----- | :------ | :------ | :--------- | :--------- | | Revenues | $76.5M | $72.4M | $4.1M | 6% | | Metric | YTD 2025 | YTD 2024 | Change ($) | Change (%) | | :----- | :------- | :------- | :--------- | :--------- | | Revenues | $154.9M | $138.6M | $16.2M | 12% | Second Quarter 2025 Financial Results MannKind's Q2 2025 results show increased revenues, higher operating expenses, and a significant foreign currency loss Revenues (Three Months Ended June 30) Total revenues for Q2 2025 increased by $4.1 million (6%) to $76.5 million, driven by Tyvaso DPI® royalties and Afrezza sales | Revenue Category | 2Q 2025 (in thousands) | 2Q 2024 (in thousands) | $ Change (in thousands) | % Change | | :--------------- | :--------------------- | :--------------------- | :---------------------- | :------- | | Royalties | $31,228 | $25,592 | $5,636 | 22% | | Collaborations and services | $22,845 | $26,014 | $(3,169) | (12%) | | Afrezza | $18,329 | $16,289 | $2,040 | 13% | | V-Go | $4,125 | $4,491 | $(366) | (8%) | | Total revenues | $76,527 | $72,386 | $4,141 | 6% | * Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI® and higher commercial product revenue for Afrezza, mainly due to higher demand and price and a lower rate of sales deductions[9] Operating Expenses and Other Financial Highlights (Three Months Ended June 30) Operating expenses rose significantly in Q2 2025, with R&D up 16% and SG&A up 31%, alongside a substantial foreign currency loss Research and Development Expenses R&D expenses increased by $1.9 million (16%) in Q2 2025 due to ICoN-1 enrollment, MNKD-201 scale-up, and personnel costs * Research and development expenses increased by $1.9 million, or 16%, for the three months ended June 30, 2025, compared to the same period in the prior year[12] * The increase was primarily attributable to continued patient enrollment in the ICoN-1 study for MNKD-101, clinical production scale up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction[12] Selling, General and Administrative Expenses SG&A expenses increased by $7.5 million (31%) in Q2 2025, mainly due to higher headcount and Afrezza promotional costs * Selling, general and administrative expenses increased by $7.5 million, or 31%, for the three months ended June 30, 2025, compared to the same period in the prior year[12] * The increase was primarily driven by higher headcount and personnel-related costs, including deploying a medical science liaison team, and higher Afrezza promotional costs[12] Foreign Currency Transaction Impact MannKind reported a $5.4 million loss on foreign currency transactions in Q2 2025, a shift from a $0.5 million gain in the prior year * Loss on foreign currency transaction was $5.4 million for the three months ended June 30, 2025, compared to a gain of $0.5 million for the same period in the prior year[12] * This was due to fluctuations in U.S. dollar to Euro exchange rates associated with future purchase commitments under the Insulin Supply Agreement with Amphastar[12] Net Income (Loss) and EPS (Three Months Ended June 30) Q2 2025 GAAP net income was $0.7 million ($0.00 basic EPS), an improvement from a $2.0 million net loss | Metric | 2Q 2025 (GAAP) | 2Q 2024 (GAAP) | Change ($) | | :----- | :------------- | :------------- | :--------- | | Net Income (Loss) | $0.7M | $(2.0)M | $2.7M | | Basic EPS | $0.00 | $(0.01) | N/A | | Metric | 2Q 2025 (Non-GAAP) | 2Q 2024 (Non-GAAP) | Change ($) | Change (%) | | :----- | :----------------- | :----------------- | :--------- | :--------- | | Net Income | $13.9M | $14.3M | $(0.4)M | (3%) | | Basic EPS | $0.05 | $0.05 | N/A | Year-to-Date 2025 Financial Results MannKind's year-to-date 2025 results show strong revenue growth, increased operating expenses, and a significant foreign currency loss Revenues (Six Months Ended June 30) Total revenues for YTD 2025 increased by $16.2 million (12%) to $154.9 million, driven by Tyvaso DPI® royalties and collaboration revenue | Revenue Category | YTD 2025 (in thousands) | YTD 2024 (in thousands) | $ Change (in thousands) | % Change | | :--------------- | :---------------------- | :---------------------- | :---------------------- | :------- | | Royalties | $61,233 | $48,243 | $12,990 | 27% | | Collaborations and services | $52,221 | $50,862 | $1,359 | 3% | | Afrezza | $33,216 | $30,727 | $2,489 | 8% | | V-Go | $8,211 | $8,817 | $(606) | (7%) | | Total revenues | $154,881 | $138,649 | $16,232 | 12% | * Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI® and higher revenue from collaborations and services due to increased product sold to United Therapeutics Corporation[13] Operating Expenses and Other Financial Highlights (Six Months Ended June 30) YTD 2025 R&D expenses increased by 13% and SG&A by 22%, reflecting pipeline investment and commercial activities, plus a foreign currency loss Research and Development Expenses YTD 2025 R&D expenses increased by $2.9 million (13%) due to ICoN-1 enrollment, MNKD-201 scale-up, and personnel costs * Research and development expenses increased by $2.9 million, or 13%, for the six months ended June 30, 2025, compared to the same period in the prior year[16] * The increase was primarily attributable to continued patient enrollment in ICoN-1 study, clinical production scale up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction[16] Selling, General and Administrative Expenses YTD 2025 SG&A expenses increased by $10.2 million (22%), mainly due to higher headcount and Afrezza promotional costs * Selling, general and administrative expenses increased by $10.2 million, or 22%, for the six months ended June 30, 2025, compared to the same period in the prior year[16] * The increase was largely attributable to higher headcount and personnel-related expenses as well as deploying a medical science liaison team, and Afrezza promotional costs[16] Foreign Currency Transaction Impact MannKind reported a $7.9 million loss on foreign currency transactions YTD 2025, a reversal from a $1.9 million gain in the prior year * Loss on foreign currency transactions was $7.9 million for the six months ended June 30, 2025, compared to a gain of $1.9 million for the same period in the prior year[16] * This was due to fluctuations in U.S. dollar to Euro exchange rates related to the future purchase commitments[16] Net Income (Loss) and EPS (Six Months Ended June 30) YTD 2025 GAAP net income was $13.8 million ($0.05 basic EPS), an increase of $5.2 million from the prior year | Metric | YTD 2025 (GAAP) | YTD 2024 (GAAP) | Change ($) | | :----- | :-------------- | :-------------- | :--------- | | Net Income | $13.8M | $8.6M | $5.2M | | Basic EPS | $0.05 | $0.03 | N/A | | Metric | YTD 2025 (Non-GAAP) | YTD 2024 (Non-GAAP) | Change ($) | Change (%) | | :----- | :------------------ | :------------------ | :--------- | :--------- | | Net Income | $35.5M | $29.4M | $6.1M | 21% | | Basic EPS | $0.12 | $0.11 | N/A | Company Information This section details MannKind's conference call, company overview, forward-looking statements, and trademark/contact information Conference Call Details MannKind will host a conference call and webcast on August 6, 2025, at 9:00 a.m. ET to discuss results * Conference call and presentation webcast to discuss results today at 9:00 a.m. Eastern Time[18] * The webcast will be accessible via a link on MannKind's website, with a replay available within 24 hours and accessible for approximately 90 days[18] About MannKind MannKind develops innovative inhaled therapeutics for endocrine and orphan lung diseases, leveraging dry-powder formulations for deep lung delivery * MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases[19] * Committed to using formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension[20] * Signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung[20] Forward-Looking Statements This section contains forward-looking statements regarding clinical trials, regulatory events, and tariff exposure, subject to risks in SEC filings * Statements regarding MannKind's expectations about patient enrollment timelines for MNKD-101, the initiation of a Phase 2 study of MNKD-201, the expected timing for trial results and regulatory events related to Afrezza, and potential tariff exposure are forward-looking statements[22] * Actual results and the timing of events could differ materially from those anticipated due to various risks and uncertainties, including those detailed in MannKind's filings with the Securities and Exchange Commission ('SEC')[22] Trademarks and Contacts This section identifies trademarks like Tyvaso DPI®, AFREZZA®, MANNKIND®, and V-GO®, and provides investor and media contact information * Tyvaso DPI is a trademark of United Therapeutics Corporation[23] * AFREZZA, MANNKIND, and V-GO are registered trademarks of MannKind Corporation[23] * Investor Relations contact: Ana Kapor, ir@mnkd.com. Media Relations contact: Christie Iacangelo, media@mnkd.com[24] Consolidated Financial Statements This section presents MannKind's Consolidated Statements of Operations and Balance Sheets for Q2 and YTD 2025 Consolidated Statements of Operations The Statements of Operations detail MannKind's revenues, expenses, and net income (loss) for Q2 and YTD 2025 | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Total revenues | $76,527 | $72,386 | $154,881 | $138,649 | | Total expenses | $71,228 | $55,776 | $127,289 | $105,317 | | Income from operations | $5,299 | $16,610 | $27,592 | $33,332 | | Net income (loss) | $668 | $(2,014) | $13,826 | $8,616 | | Net income (loss) per share – basic | $0.00 | $(0.01) | $0.05 | $0.03 | Consolidated Balance Sheets The Balance Sheets present MannKind's financial position as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and equity | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total assets | $411,697 | $393,843 | | Total liabilities | $466,739 | $472,659 | | Total stockholders' deficit | $(55,042) | $(78,816) | | Cash and cash equivalents | $57,006 | $46,339 | | Short-term investments | $121,979 | $150,917 | Non-GAAP Financial Measures This section explains MannKind's non-GAAP financial measures for net income and EPS, with a detailed reconciliation to GAAP results Non-GAAP Explanation MannKind provides non-GAAP financial measures for net income and basic EPS to offer additional insight into financial performance and underlying trends * Non-GAAP financial measures for net income and net income per share – basic are provided to supplement GAAP statements and offer additional understanding of business operating results, including underlying trends[29] * These measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with GAAP financial statements; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles[30] Non-GAAP Reconciliation This section reconciles GAAP to non-GAAP net income and basic EPS for Q2 and YTD 2025, outlining specific adjustments | Non-GAAP Adjustment (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | GAAP reported net income | $668 | $(2,014) | $13,826 | $8,616 | | Sold portion of royalty revenue | $(3,123) | $(2,559) | $(6,123) | $(4,824) | | Interest expense on liability for sale of future royalties | $3,473 | $4,383 | $7,050 | $8,631 | | Stock compensation | $7,520 | $6,428 | $12,905 | $10,313 | | Loss (gain) on foreign currency transaction | $5,363 | $(529) | $7,872 | $(1,928) | | Loss on settlement of debt | — | $7,050 | — | $7,050 | | Loss on available-for-sale securities | — | $1,550 | — | $1,550 | | Non-GAAP adjusted net income | $13,901 | $14,309 | $35,530 | $29,408 | | Basic EPS (Non-GAAP) | $0.05 | $0.05 | $0.12 | $0.11 |