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MannKind Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

1. MannKind's 2024 revenues reached $286M, a 43% increase YoY. 2. Afrezza for pediatric use to seek FDA approval in 1H 2025. 3. MannKind reduced $236M debt, maintaining $36M convertible debt. 4. Dominic Marasco appointed as President, aiming for Afrezza growth. 5. Phase 3 trials for MNKD-101 and MNKD-201 progressing well.

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$5.2302/27 10:46 PM EDTLatest Updated
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Why Bullish?

MannKind's significant revenue growth and plans for pipeline expansion signal positive momentum. Previous price reactions to positive earnings reports and pipeline advancements have resulted in increased stock value.

How important is it?

The article outlines strategic advancements and financial success, which reflect positively on MNKD's future. Positive developments in product approval processes particularly resonate with investors, increasing the likelihood of market impact.

Why Long Term?

Continued revenue growth and successful trial outcomes could enhance market positioning and investor confidence. Historical trends indicate that sustained financial performance and FDA approvals lead to long-term stock appreciation.

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2024 revenues of $286M, +43% v. 2023; 4Q 2024 revenues of $77M, +31% v. 4Q 20232024 net income of $28M; Non-GAAP net income of $68M 4Q 2024 net income of $7M; Non-GAAP net income of $23MReduced debt principal by $236M; remaining convertible debt of $36MYear-end 2024 cash, cash equivalents and investments of $203MAdvanced pipeline: Reported primary endpoint of INHALE-1 for Afrezza in pediatricsProgressed MNKD-101 to Global Phase 3Completed Phase 1 of MNKD-201 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- 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 announcedRequested 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 populationExpect twelve-month data set with safety extension in 1H 2025Anticipate 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 reportedExpect 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 UnitAfrezza INHALE-3 Phase 4 clinical trial 17-week data published in Diabetes Care; 30-week data manuscripts expected to be published in 1H 2025Inhaled insulin recognized as comparable to injectable insulin in the American Diabetes Association® Standards of Care in Diabetes – 2025Label application to update initial Afrezza conversion dose submitted to FDAAfrezza 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 millionEliminated 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 2026Utilized a combination of cash and stock to avoid potential dilution of 12 million shares of common stockInterest 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 MeasuresTo 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.

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