|
|
|
|
|||||
|
|
|
Conference call today at 9:00 am ET
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the third quarter of 2025 and provided a business update.
“The acquisition of scPharmaceuticals marks a significant expansion of our commercial capabilities and is expected to accelerate growth of our product revenues and build upon our commitment to delivering innovative, patient-centric therapies,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “With the FDA’s acceptance for review of the Afrezza pediatric sBLA, the submission of the FUROSCIX ReadyFlow Autoinjector sNDA, and continued progress in the pipeline programs, we are executing across a diversified portfolio with significant growth opportunities ahead.”
Business Update and Upcoming Milestones
scPharmaceuticals Acquisition
Afrezza
Inhaled Clofazimine
Nintedanib DPI (MNKD-201)
Pre-clinical
Corporate and Financial
Third Quarter 2025 Financial Results
Revenues
| Three Months Ended September 30, | ||||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Revenues | (Dollars in thousands) | |||||||||||||||
| Royalties | $ | 33,319 | $ | 27,083 | $ | 6,236 | 23 | % | ||||||||
| Collaborations and services | 26,506 | 23,268 | $ | 3,238 | 14 | % | ||||||||||
| Afrezza | 18,493 | 15,035 | $ | 3,458 | 23 | % | ||||||||||
| V-Go | 3,812 | 4,693 | $ | (881 | ) | (19 | %) | |||||||||
| Total revenues | $ | 82,130 | $ | 70,079 | $ | 12,051 | 17 | % | ||||||||
Total revenues increased $12.1 million, or 17% for the third quarter of 2025 compared to the same period in the prior year. Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI®, higher revenue from collaborations and services due to increased product sold to United Therapeutics Corporation (“UT”) and MannKind’s co-promotion agreement with Amphastar, as well as higher commercial product revenue for Afrezza, mainly due to higher price and demand and a lower rate of sales deductions. There was a decrease in net revenue for V-Go® due to lower demand, partially offset by higher price and lower rebates on certain commercial contracts.
Operating Expenses and Other Financial Highlights
Nine Months Ended September 30, 2025
Revenues
| Nine Months Ended September 30, | ||||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Revenues | (Dollars in thousands) | |||||||||||||||
| Royalties | $ | 94,552 | $ | 75,326 | $ | 19,226 | 26 | % | ||||||||
| Collaborations and services | 78,727 | 74,130 | $ | 4,597 | 6 | % | ||||||||||
| Afrezza | 51,709 | 45,762 | $ | 5,947 | 13 | % | ||||||||||
| V-Go | 12,023 | 13,510 | $ | (1,487 | ) | (11 | %) | |||||||||
| Total revenues | $ | 237,011 | $ | 208,728 | $ | 28,283 | 14 | % | ||||||||
Total revenues increased $28.3 million, or 14%, for the nine months ended September 30, 2025 compared to the same period in the prior year. Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI®, higher revenue from collaborations and services due to increased product sold to UT and MannKind’s co-promotion agreement with Amphastar, as well as higher commercial product revenue for Afrezza, mainly due to higher price and demand, partially offset by a decrease in net revenue for V-Go® due to lower demand. The decrease in demand for V-Go was partially offset by higher price and lower rebates on certain commercial contracts.
Operating Expenses and Other Financial Highlights
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 the potential benefits from the scPharma acquisition, including diversifying and accelerating revenue growth; MannKind’s ongoing clinical trials and preclinical studies, including the Phase 3 clinical trial of MNKD-101 and the timing for patient enrollment for and an interim analysis thereof and the Phase 2 study of MNKD-201 and the expected initiation and patient enrollment timelines thereof, and the expected timing for trial results; the development of a new dry powder inhalation therapy and investigational molecule under the expanded collaboration with United Therapeutics and the planned preclinical studies thereof; the expected timing for regulatory events related to Afrezza and the FUROSCIX ReadyFlow™ Autoinjector; and other statements about future events. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “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 and uncertainties associated with competition; commercial execution; regulatory changes impacting the pharmaceutical, medical device and healthcare industries; developing product candidates; unforeseen delays that may impact the timing of clinical trials and reporting data; the regulatory review process; manufacturing; intellectual property protection; personnel; and macroeconomic and geopolitical factors. These and other risks are detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its most recently filed Quarterly Report on Form 10-Q. 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, MANNKIND, SCPHARMACEUTICALS and V-GO are registered trademarks and FUROSCIX READYFLOW is a trademark of MannKind Corporation or its subsidiaries.
| MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (In thousands except per share data) | ||||||||||||||||
| Revenues: | ||||||||||||||||
| Commercial product sales | $ | 22,305 | $ | 19,728 | $ | 63,732 | $ | 59,272 | ||||||||
| Collaborations and services | 26,506 | 23,268 | 78,727 | 74,130 | ||||||||||||
| Royalties | 33,319 | 27,083 | 94,552 | 75,326 | ||||||||||||
| Total revenues | 82,130 | 70,079 | 237,011 | 208,728 | ||||||||||||
| Expenses: | ||||||||||||||||
| Cost of goods sold – commercial | 4,498 | 3,197 | 12,873 | 12,621 | ||||||||||||
| Cost of revenue – collaborations and services | 15,705 | 14,826 | 45,414 | 44,377 | ||||||||||||
| Research and development | 14,063 | 12,926 | 38,760 | 34,755 | ||||||||||||
| Selling, general and administrative | 29,088 | 23,916 | 85,724 | 70,357 | ||||||||||||
| (Gain) loss on foreign currency transaction | (120 | ) | 2,454 | 7,752 | 526 | |||||||||||
| Total expenses | 63,234 | 57,319 | 190,523 | 162,636 | ||||||||||||
| Income from operations | 18,896 | 12,760 | 46,488 | 46,092 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 2,628 | 3,179 | 6,416 | 9,790 | ||||||||||||
| Interest expense | (1,364 | ) | (1,801 | ) | (6,294 | ) | (10,419 | ) | ||||||||
| Interest expense on liability for sale of future royalties | (3,514 | ) | (4,089 | ) | (10,564 | ) | (12,720 | ) | ||||||||
| Interest expense on financing liability | (2,456 | ) | (2,470 | ) | (7,299 | ) | (7,361 | ) | ||||||||
| Impairment of available-for-sale investment | (6,409 | ) | — | (6,409 | ) | (1,550 | ) | |||||||||
| Other income | — | 32 | — | 32 | ||||||||||||
| Gain on bargain purchase | — | 5,259 | — | 5,259 | ||||||||||||
| Loss on settlement of debt | — | — | — | (7,050 | ) | |||||||||||
| Total other expense | (11,115 | ) | 110 | (24,150 | ) | (24,019 | ) | |||||||||
| Income before income tax (benefit) expense | 7,781 | 12,870 | 22,338 | 22,073 | ||||||||||||
| Income tax (benefit) expense | (204 | ) | 1,320 | 527 | 1,907 | |||||||||||
| Net income | $ | 7,985 | $ | 11,550 | $ | 21,811 | $ | 20,166 | ||||||||
| Net income per share – basic | $ | 0.03 | $ | 0.04 | $ | 0.07 | $ | 0.07 | ||||||||
| Weighted average shares used to compute net income per share – basic | 306,806 | 274,998 | 305,093 | 272,811 | ||||||||||||
| Net income per share – diluted | $ | 0.03 | $ | 0.04 | $ | 0.07 | $ | 0.07 | ||||||||
| Weighted average shares used to compute net income per share – diluted | 311,638 | 284,693 | 313,339 | 281,407 | ||||||||||||
| MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| (In thousands except share and per share data) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 127,392 | $ | 46,339 | ||||
| Short-term investments | 132,643 | 150,917 | ||||||
| Accounts receivable, net | 17,383 | 11,804 | ||||||
| Inventory | 26,972 | 27,886 | ||||||
| Prepaid expenses and other current assets | 54,447 | 31,360 | ||||||
| Total current assets | 358,837 | 268,306 | ||||||
| Restricted cash | 743 | 737 | ||||||
| Long-term investments | 26,226 | 5,482 | ||||||
| Property and equipment, net | 82,652 | 85,365 | ||||||
| Goodwill | 1,931 | 1,931 | ||||||
| Other intangible assets | 5,120 | 5,265 | ||||||
| Other assets | 19,131 | 26,757 | ||||||
| Total assets | $ | 494,640 | $ | 393,843 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,269 | $ | 6,792 | ||||
| Accrued expenses and other current liabilities | 31,419 | 40,293 | ||||||
| Senior convertible notes – current | 36,224 | — | ||||||
| Liability for sale of future royalties – current | 13,841 | 12,283 | ||||||
| Financing liability – current | 10,254 | 10,062 | ||||||
| Deferred revenue – current | 10,123 | 12,407 | ||||||
| Total current liabilities | 109,130 | 81,837 | ||||||
| Liability for sale of future royalties – long term | 136,913 | 137,362 | ||||||
| Financing liability – long term | 93,310 | 93,877 | ||||||
| Deferred revenue – long term | 48,194 | 51,160 | ||||||
| Recognized loss on purchase commitments – long term | 65,956 | 58,204 | ||||||
| Operating lease liability | 10,258 | 11,645 | ||||||
| Milestone liabilities | 2,003 | 2,523 | ||||||
| Term loan | 73,428 | — | ||||||
| Senior convertible notes | — | 36,051 | ||||||
| Total liabilities | 539,192 | 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 September 30, 2025 or December 31, 2024 | — | — | ||||||
| Common stock, $0.01 par value – 800,000,000 shares authorized; 307,027,189 and 302,959,782 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 3,070 | 3,029 | ||||||
| Additional paid-in capital | 3,132,249 | 3,118,865 | ||||||
| Accumulated other comprehensive income | 137 | 1,109 | ||||||
| Accumulated deficit | (3,180,008 | ) | (3,201,819 | ) | ||||
| Total stockholders' deficit | (44,552 | ) | (78,816 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 494,640 | $ | 393,843 | ||||
Non-GAAP Measures
To supplement MannKind's condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP financial measures for net income and net income per share – basic. We are providing these non-GAAP financial measures, which are among the indicators management uses as a basis for evaluating our financial performance, to disclose additional information to facilitate the comparison of past and present operations. 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 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 press release 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 and net income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||||||||||
| Net Income | Basic EPS | Net Income | Basic EPS | Net Income | Basic EPS | Net Income | Basic EPS | ||||||||||||||||||||||||
| (In thousands except per share data) | |||||||||||||||||||||||||||||||
| GAAP reported net income | $ | 7,985 | $ | 0.03 | $ | 11,550 | $ | 0.04 | $ | 21,811 | $ | 0.07 | $ | 20,166 | $ | 0.07 | |||||||||||||||
| Non-GAAP adjustments: | |||||||||||||||||||||||||||||||
| Sold portion of royalty revenue (1) | (3,332 | ) | (0.01 | ) | (2,708 | ) | (0.01 | ) | (9,455 | ) | (0.03 | ) | (7,533 | ) | (0.03 | ) | |||||||||||||||
| Interest expense on liability for sale of future royalties | 3,514 | 0.01 | 4,089 | 0.02 | 10,564 | 0.03 | 12,720 | 0.04 | |||||||||||||||||||||||
| Acquisition related expenses (2) | 3,673 | 0.01 | — | — | 3,673 | 0.01 | — | — | |||||||||||||||||||||||
| Impairment loss on available-for-sale investment | 6,409 | 0.02 | — | — | 6,409 | 0.02 | 1,550 | 0.01 | |||||||||||||||||||||||
| Stock compensation | 4,318 | 0.01 | 5,227 | 0.02 | 17,223 | 0.06 | 15,540 | 0.06 | |||||||||||||||||||||||
| (Gain) loss on foreign currency transaction | (120 | ) | — | 2,454 | 0.01 | 7,752 | 0.03 | 526 | — | ||||||||||||||||||||||
| Gain on bargain purchase | — | — | (5,259 | ) | (0.02 | ) | — | — | (5,259 | ) | (0.02 | ) | |||||||||||||||||||
| Loss on settlement of debt | — | — | — | — | — | — | 7,050 | 0.03 | |||||||||||||||||||||||
| Non-GAAP net income | $ | 22,447 | $ | 0.07 | $ | 15,353 | $ | 0.06 | $ | 57,977 | $ | 0.19 | $ | 44,760 | $ | 0.16 | |||||||||||||||
| Weighted average shares used to compute net income per share – basic | 306,806 | 274,998 | 305,093 | 272,811 | |||||||||||||||||||||||||||
1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and nine months ended September 30, 2025 and 2024, which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. Our royalties from collaborations during the three and nine months ended September 30, 2025 totaled $33.3 million and $94.6 million, respectively, of which $3.3 million and $9.5 million, respectively were remitted to the royalty purchaser.
2) Represents transaction fees incurred during the three and nine months ended September 30, 2025 associated with the acquisition of scPharma.
CONTACT: MannKind Contacts: Investor Relations Ana Kapor Email: [email protected] Media Relations Christie Iacangelo Email: [email protected]
| Nov-05 | |
| Nov-05 | |
| Nov-05 | |
| Nov-05 | |
| Nov-04 | |
| Oct-30 | |
| Oct-29 | |
| Oct-13 | |
| Oct-07 | |
| Sep-29 | |
| Sep-10 | |
| Sep-02 | |
| Aug-31 | |
| Aug-29 | |
| Aug-29 |
Join thousands of traders who make more informed decisions with our premium features. Real-time quotes, advanced visualizations, backtesting, and much more.
Learn more about FINVIZ*Elite