MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter and year ended December 31, 2024, and provided a business update.

“Throughout 2024, we accomplished the milestones we outlined at the beginning of the year, including delivering robust revenues as we exited the year with an annual run rate of $300 million,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We are thrilled to have welcomed Dominic Marasco as President, Endocrine Business Unit, positioning Afrezza for further growth, including a planned submission this summer to seek approval in the pediatric population. In our orphan lung clinical programs, nintedanib DPI is progressing to the next phase of development and our Phase 3 trial of clofazimine inhalation suspension in NTM lung disease is expected to meet the interim enrollment target by the end of 2025.”

4Q 2024 Business Update and Upcoming Milestones

Afrezza® INHALE-1 Pediatric Phase 3 clinical trial

  • Six-month safety and efficacy results announced
  • Requested meeting with the U.S. Food and Drug Administration ("FDA") in 1H 2025 to discuss data submission for potential approval of Afrezza in the pediatric population
  • Expect twelve-month data set with safety extension in 1H 2025
  • Anticipate supplemental new drug application filing in 1H 2025 pending FDA feedback

 Clofazimine Inhalation Suspension Phase 3 (ICON-1) global clinical trial (MNKD-101)

  • Approximately 70% of anticipated sites have been activated in four countries (U.S., Japan, Australia, South Korea)
  • Patients randomized in two countries (U.S. and Australia)
  • Expect to meet the interim enrollment target by YE 2025

Nintedanib DPI Phase 1 clinical trial (MNKD-201)

  • Successfully completed Phase 1 trial, demonstrating nintedanib DPI was well tolerated with no serious adverse events or study drug discontinuation reported
  • Expect to meet with the FDA in 1H 2025 to advance MNKD-201 into next phase of development

Commercial – Endocrine Business Unit

  • Announced the appointment of Dominic Marasco as President, Endocrine Business Unit
  • Afrezza INHALE-3 Phase 4 clinical trial 17-week data published in Diabetes Care; 30-week data manuscripts expected to be published in 1H 2025
  • Inhaled insulin recognized as comparable to injectable insulin in the American Diabetes Association® Standards of Care in Diabetes – 2025
  • Label application to update initial Afrezza conversion dose submitted to FDA
  • Afrezza approved in India for adults; expect to ship in 4Q 2025 once Cipla obtains registration certificate and import license; earned $1.1M regulatory milestone

Corporate and Financial: Strong Balance Sheet

  • Cash, cash equivalents and investments as of December 31, 2024 totaled $203 million
  • Eliminated principal of $236 million across three debt instruments during 2024 resulting in:
    • Remaining outstanding debt balance of $36 million in 2.5% senior convertible notes due 2026
    • Utilized a combination of cash and stock to avoid potential dilution of 12 million shares of common stock
    • Interest expense savings of $9 million through the respective maturity dates

Fourth Quarter and Full Year 2024 Financial Results

Revenues

    Three MonthsEnded December 31,  
    2024     2023     $ Change     % Change  
Revenues   (Dollars in thousands)  
Royalties   $ 27,009     $ 21,028     $ 5,981       28 %
Collaborations and services     26,710       17,249     $ 9,461       55 %
Afrezza     18,279       15,487     $ 2,792       18 %
V-Go     4,778       4,708     $ 70       1 %
Total revenues   $ 76,776     $ 58,472     $ 18,304       31 %
    YearEnded December 31,  
    2024     2023     $ Change     % Change  
Revenues   (Dollars in thousands)  
Royalties   $ 102,335     $ 71,979     $ 30,356       42 %
Collaborations and services     100,840       52,954     $ 47,886       90 %
Afrezza     64,041       54,914     $ 9,127       17 %
V-Go     18,288       19,115     $ (827 )     (4 %)
Total revenues   $ 285,504     $ 198,962     $ 86,542       43 %

Total revenues for the fourth quarter and full year 2024 rose due to increases in revenue from royalties, collaborations and services, and commercial sales. The rise in royalties was primarily due to higher patient demand for Tyvaso DPI. Collaborations and services revenue grew due to increased manufacturing of Tyvaso DPI for United Therapeutics Corporation ("UT"). Net revenues for Afrezza and V-Go increased primarily as a result of improved gross-to-net percentages and higher demand and, to a lesser extent, pricing for Afrezza, partially offset by a decrease in V-Go product demand.

Operating Expenses and Other Financial Highlights

  • Cost of revenue – collaborations and services was $14.8 million for the fourth quarter of 2024, compared to $12.0 million for the same period in 2023, an increase of 24%. For the full year 2024, cost of revenue – collaborations and services was $59.2 million, compared to $41.9 million, an increase of 41%. These increases are primarily the result of increased manufacturing volume of Tyvaso DPI.
  • Research and development ("R&D") expenses were $11.1 million for the fourth quarter of 2024 compared to $9.2 million for the same period in 2023, an increase of 21%. For the full year 2024, R&D expenses were $45.9 million compared to $31.3 million, an increase of 47%. The increases were primarily attributable to development activities including the ICON-1 clinical study, a Phase 1 clinical study of MNKD-201, and personnel costs primarily due to increased headcount resulting from the Pulmatrix Transaction.
  • Selling, general and administrative ("SG&A") expenses were $24.0 million for the fourth quarter of 2024 compared to $20.5 million for the same period in 2023, an increase of 17%. For the full year 2024, SG&A expenses remained consistent compared to the same period in 2023. This was primarily attributable to a loss of $1.4 million for estimated returns associated with sales of V-Go that pre-date MannKind's acquisition of the product and increases in personnel costs, professional fees and promotional activities, offset by a decrease in selling expenses related to sales force restructuring activities completed during the first quarter of 2024.
  • For the fourth quarter of 2024, MannKind reported net income of $7.4 million, or $0.03 earnings per share – basic, compared to net income of $1.4 million, or $0.01 earnings per share – basic, for the same period in 2023. For the full year 2024, MannKind reported net income of $27.6 million, or $0.10 earnings per share – basic, compared to net loss of $11.9 million, or $0.04 loss per share – basic for the same period in 2023.
  • For the fourth quarter of 2024, MannKind reported non-GAAP net income of $23.0 million, or $0.08 earnings per share – basic, compared to non-GAAP net income of $7.1 million, or $0.02 earnings per share – basic, for the same period in 2023. For the full year 2024, MannKind reported non-GAAP net income of $67.7 million, or $0.25 earnings per share – basic, compared to non-GAAP net income of $5.9 million, or $0.03 earnings per share – basic for the same period in 2023. For a reconciliation of GAAP reported net income (loss) and net income (loss) per share for basic weighted average shares to these non-GAAP measures, please see the end of this press release.

Conference Call

MannKind will host a conference call and presentation 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. 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) 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.

We are committed to using our 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. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.

With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.

Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram.

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 development of Afrezza for the pediatric population, MNKD-101 and MNKD-201, including the expected timing for data readouts, regulatory filings, meetings with the FDA and patient enrollment timelines; expectations regarding the commercialization of Afrezza in India, including the estimated timing for the shipment of product; and MannKind being positioned for further growth. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “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 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; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, being filed with the SEC later today, and subsequent periodic reports 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, MANNKIND, and V-GO are registered trademarks of MannKind Corporation.

MANNKIND CORPORATION AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS
    Three MonthsEnded December 31,     YearEnded December 31,  
    2024     2023     2024     2023  
    (In thousands except per share data)  
Revenues:                        
Commercial product sales   $ 23,057     $ 20,195     $ 82,329     $ 74,029  
Collaborations and services     26,710       17,249       100,840       52,954  
Royalties     27,009       21,028       102,335       71,979  
Total revenues     76,776       58,472       285,504       198,962  
Expenses:                        
Cost of goods sold     4,808       6,114       17,429       20,863  
Cost of revenue – collaborations and services     14,796       11,953       59,173       41,908  
Research and development     11,138       9,236       45,893       31,283  
Selling, general and administrative     23,972       20,535       94,329       94,314  
(Gain) loss on foreign currency transaction     (4,433 )     2,776       (3,907 )     1,916  
Total expenses     50,281       50,614       212,917       190,284  
Income (loss) from operations     26,495       7,858       72,587       8,678  
Other income (expense):                        
Interest income, net     2,825       1,725       12,615       6,154  
Interest expense on liability for sale of future royalties     (3,452 )     (185 )     (16,172 )     (185 )
Interest expense on financing liability     (2,467 )     (2,493 )     (9,828 )     (9,825 )
Interest expense     (1,562 )     (2,677 )     (11,981 )     (15,151 )
Gain on bargain purchase     —       —       5,259       —  
Other income (expense)     —       (164 )     32       122  
Loss on settlement of debt     (13,394 )     —       (20,444 )     —  
Loss on available-for-sale securities     —       (1,102 )     (1,550 )     (170 )
Total other expense     (18,050 )     (4,896 )     (42,069 )     (19,055 )
Income (loss) before income tax expense     8,445       2,962       30,518       (10,377 )
Income tax expense     1,023       1,561       2,930       1,561  
Net income (loss)   $ 7,422     $ 1,401     $ 27,588     $ (11,938 )
Net income (loss) per share – basic   $ 0.03     $ 0.01     $ 0.10     $ (0.04 )
Weighted average shares used to compute net income (loss)    per share – basic     279,191       269,648       274,415       267,014  
Net income (loss) per share – diluted   $ 0.03     $ 0.00     $ 0.10     $ (0.04 )
Weighted average shares used to compute net income (loss)    per share – diluted(1)     290,631       323,880       283,844       267,014  

_________________(1) Diluted weighted average shares ("DWAS") differs from basic weighted average shares due to the weighted average number of shares that would be outstanding upon exercise or vesting of outstanding share-based payments to employees and conversion of convertible notes.  For the year ended December 31, 2024, DWAS included 9,429 shares issuable upon exercise or vesting of outstanding share-based payments. 6,967 shares issuable upon conversion of our senior convertible notes were excluded as their effect would be antidilutive.

MANNKIND CORPORATION AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS
             
    December 31, 2024     December 31, 2023  
    (In thousands except shareand per share data)  
ASSETS            
Current assets:            
Cash and cash equivalents   $ 46,339     $ 238,480  
Short-term investments     150,917       56,619  
Accounts receivable, net     11,804       14,901  
Inventory     27,886       28,545  
Prepaid expenses and other current assets     31,360       34,848  
Total current assets     268,306       373,393  
Restricted cash     737       —  
Long-term investments     5,482       7,155  
Property and equipment, net     85,365       84,220  
Goodwill     1,931       1,931  
Other intangible assets     5,265       1,073  
Other assets     26,757       7,426  
Total assets   $ 393,843     $ 475,198  
             
LIABILITIES AND STOCKHOLDERS' DEFICIT            
Current liabilities:            
Accounts payable   $ 6,792     $ 9,580  
Accrued expenses and other current liabilities     40,293       42,036  
Liability for sale of future royalties – current     12,283       9,756  
Financing liability – current     10,062       9,809  
Deferred revenue – current     12,407       9,085  
Recognized loss on purchase commitments – current     —       3,859  
Midcap credit facility – current     —       20,000  
Total current liabilities     81,837       104,125  
Senior convertible notes     36,051       226,851  
Liability for sale of future royalties – long term     137,362       136,054  
Financing liability – long term     93,877       94,319  
Deferred revenue – long term     51,160       69,794  
Recognized loss on purchase commitments – long term     58,204       60,942  
Operating lease liability     11,645       3,925  
Milestone liabilities     2,523       3,452  
Midcap credit facility – long term     —       13,019  
Mann Group convertible note     —       8,829  
Accrued interest – Mann Group convertible note     —       56  
Total liabilities     472,659       721,366  
Stockholders' deficit:            
Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized;    no shares issued or outstanding as of December 31, 2024 or 2023     —       —  
Common stock, $0.01 par value – 800,000,000 shares authorized;  302,959,782 and 270,034,495 shares issued and outstanding as of   December 31, 2024 and 2023, respectively     3,029       2,700  
Additional paid-in capital     3,118,865       2,980,539  
Accumulated other comprehensive income     1,109       —  
Accumulated deficit     (3,201,819 )     (3,229,407 )
Total stockholders' deficit     (78,816 )     (246,168 )
Total liabilities and stockholders' deficit   $ 393,843     $ 475,198  

Non-GAAP Measures To supplement our consolidated financial statements presented under GAAP, we are presenting non-GAAP net income (loss) and non-GAAP net income (loss) 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 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 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 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 income (loss) and net income (loss) per share ("EPS") for basic weighted average shares as reported in our consolidated statement of operations to a non-GAAP presentation:

  Three Months Ended December 31,     Year Ended December 31,  
  2024     2023     2024     2023  
  NetIncome     BasicEPS     NetIncome     BasicEPS     NetIncome     BasicEPS     NetIncome(Loss)     BasicEPS  
  (In thousands except per share data)  
GAAP reported net income (loss) $ 7,422     $ 0.03     $ 1,401     $ 0.01     $ 27,588     $ 0.10     $ (11,938 )   $ (0.04 )
Non-GAAP adjustments:                                              
Sold portion of royalty revenue (1)   (2,701 )     (0.01 )     (2,103 )     (0.01 )     (10,234 )     (0.04 )     (2,103 )     (0.01 )
Interest expense on liability for sale of future royalties   3,452       0.01       185       —       16,172       0.06       185       —  
Stock compensation   5,818       0.02       3,786       0.01       21,358       0.08       17,649       0.07  
(Gain) loss on foreign currency transaction   (4,433 )     (0.02 )     2,776       0.01       (3,907 )     (0.01 )     1,916       0.01  
Gain on bargain purchase   —       —       —       —       (5,259 )     (0.02 )     —       —  
Loss on settlement of debt   13,394       0.05       —       —       20,444       0.07       —       —  
Loss on available-for-sale securities   —       —       1,102       —       1,550       0.01       170       —  
Non-GAAP adjusted net income (loss) $ 22,952     $ 0.08     $ 7,147     $ 0.02     $ 67,712     $ 0.25     $ 5,879     $ 0.03  
Weighted average shares used to compute net income (loss)     per share – basic   279,191             269,648             274,415             267,014        

_________________(1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI which is remitted to the royalty purchaser and recognized as royalties from collaborations in our consolidated statements of operations.

MannKind Contacts:
Investor Relations
Ana Kapor
(818) 661-5000
Email: ir@mnkd.com

Media Relations
Christie Iacangelo
(818) 292-3500
Email: media@mnkd.com
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