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.


MannKind Contacts:
Investor Relations
Ana Kapor
Email: ir@mnkd.com 

Media Relations
Christie Iacangelo
Email: media@mnkd.com 

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