MannKind Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
MannKind (MNKD) reported strong financial results for Q4 and full year 2024. The company achieved annual revenues of $286M, up 43% from 2023, with Q4 revenues of $77M (+31% YoY). Net income for 2024 reached $28M, with Q4 contributing $7M.
Key financial highlights include debt principal reduction of $236M, with remaining convertible debt of $36M, and year-end cash position of $203M. The company made significant clinical progress, including positive results from the INHALE-1 pediatric trial for Afrezza, advancement of MNKD-101 to Global Phase 3, and completion of MNKD-201 Phase 1.
Commercial developments include Afrezza's approval in India with expected shipments in Q4 2025, and the appointment of Dominic Marasco as President of the Endocrine Business Unit. The company maintains a strong growth trajectory with an annual run rate of $300M by year-end.
MannKind (MNKD) ha riportato risultati finanziari solidi per il quarto trimestre e per l'intero anno 2024. L'azienda ha raggiunto entrate annuali di 286 milioni di dollari, con un aumento del 43% rispetto al 2023, e un fatturato nel quarto trimestre di 77 milioni di dollari (+31% su base annua). Il reddito netto per il 2024 ha raggiunto i 28 milioni di dollari, con il quarto trimestre che ha contribuito con 7 milioni di dollari.
I principali punti salienti finanziari includono una riduzione del debito principale di 236 milioni di dollari, con un debito convertibile residuo di 36 milioni di dollari, e una posizione di cassa a fine anno di 203 milioni di dollari. L'azienda ha fatto progressi clinici significativi, inclusi risultati positivi dallo studio pediatrico INHALE-1 per Afrezza, l'avanzamento di MNKD-101 alla Fase 3 Globale, e il completamento della Fase 1 di MNKD-201.
Sviluppi commerciali includono l'approvazione di Afrezza in India con spedizioni previste nel quarto trimestre del 2025, e la nomina di Dominic Marasco come Presidente dell'Unità Commerciale Endocrina. L'azienda mantiene una forte traiettoria di crescita con un tasso annuale di 300 milioni di dollari entro la fine dell'anno.
MannKind (MNKD) informó resultados financieros sólidos para el cuarto trimestre y el año completo 2024. La compañía logró ingresos anuales de 286 millones de dólares, un aumento del 43% en comparación con 2023, con ingresos del cuarto trimestre de 77 millones de dólares (+31% interanual). El ingreso neto para 2024 alcanzó los 28 millones de dólares, con el cuarto trimestre contribuyendo con 7 millones de dólares.
Los aspectos financieros clave incluyen una reducción del principal de la deuda de 236 millones de dólares, con una deuda convertible restante de 36 millones de dólares, y una posición de efectivo al final del año de 203 millones de dólares. La compañía hizo avances clínicos significativos, incluidos resultados positivos del ensayo pediátrico INHALE-1 para Afrezza, el avance de MNKD-101 a la Fase 3 Global, y la finalización de la Fase 1 de MNKD-201.
Los desarrollos comerciales incluyen la aprobación de Afrezza en India con envíos esperados en el cuarto trimestre de 2025, y el nombramiento de Dominic Marasco como Presidente de la Unidad de Negocios Endocrinos. La compañía mantiene una sólida trayectoria de crecimiento con una tasa anual de 300 millones de dólares para fin de año.
MannKind (MNKD)는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했습니다. 이 회사는 연간 수익 2억 8천6백만 달러를 달성했으며, 이는 2023년 대비 43% 증가한 수치이고, 4분기 수익은 7천7백만 달러(+31% 전년 대비)였습니다. 2024년 순이익은 2천8백만 달러에 달했으며, 4분기가 7백만 달러를 기여했습니다.
주요 재무 하이라이트로는 2억 3천6백만 달러의 부채 원금 감소, 3천6백만 달러의 남은 전환사채, 그리고 연말 현금 보유액 2억 3천만 달러가 포함됩니다. 이 회사는 Afrezza에 대한 INHALE-1 소아 시험의 긍정적인 결과, MNKD-101의 글로벌 3상으로의 발전, MNKD-201 1상의 완료 등에서 상당한 임상 진전을 이루었습니다.
상업적 개발에는 인도에서 Afrezza의 승인과 2025년 4분기 배송 예정이 포함되며, Dominic Marasco가 내분비 사업부의 사장으로 임명되었습니다. 이 회사는 연말까지 연간 3억 달러의 성장 궤적을 유지하고 있습니다.
MannKind (MNKD) a annoncé de solides résultats financiers pour le quatrième trimestre et l'année entière 2024. L'entreprise a réalisé des revenus annuels de 286 millions de dollars, en hausse de 43 % par rapport à 2023, avec des revenus de 77 millions de dollars au quatrième trimestre (+31 % en glissement annuel). Le revenu net pour 2024 a atteint 28 millions de dollars, avec 7 millions de dollars provenant du quatrième trimestre.
Les points forts financiers clés incluent une réduction du principal de la dette de 236 millions de dollars, avec une dette convertible restante de 36 millions de dollars, et une position de trésorerie à la fin de l'année de 203 millions de dollars. L'entreprise a réalisé des progrès cliniques significatifs, y compris des résultats positifs de l'essai pédiatrique INHALE-1 pour Afrezza, l'avancement de MNKD-101 à la phase 3 mondiale, et l'achèvement de la phase 1 de MNKD-201.
Les développements commerciaux incluent l'approbation d'Afrezza en Inde avec des expéditions attendues au quatrième trimestre 2025, et la nomination de Dominic Marasco en tant que président de l'unité commerciale endocrinienne. L'entreprise maintient une forte trajectoire de croissance avec un taux de 300 millions de dollars par an d'ici la fin de l'année.
MannKind (MNKD) hat starke finanzielle Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 gemeldet. Das Unternehmen erzielte Jahresumsätze von 286 Millionen Dollar, was einem Anstieg von 43% im Vergleich zu 2023 entspricht, mit Umsätzen im vierten Quartal von 77 Millionen Dollar (+31% im Jahresvergleich). Der Nettogewinn für 2024 erreichte 28 Millionen Dollar, wobei das vierte Quartal 7 Millionen Dollar beitrug.
Wichtige finanzielle Höhepunkte umfassen eine Reduzierung des Schuldenhauptbetrags um 236 Millionen Dollar, mit verbleibenden wandelbaren Schulden von 36 Millionen Dollar und einer Cash-Position zum Jahresende von 203 Millionen Dollar. Das Unternehmen hat bedeutende klinische Fortschritte erzielt, einschließlich positiver Ergebnisse aus der INHALE-1-Pädiatrie-Studie für Afrezza, dem Fortschritt von MNKD-101 in die globale Phase 3 und dem Abschluss der Phase 1 von MNKD-201.
Zu den kommerziellen Entwicklungen gehört die Genehmigung von Afrezza in Indien mit erwarteten Lieferungen im vierten Quartal 2025 sowie die Ernennung von Dominic Marasco zum Präsidenten der Endokrinen Geschäftseinheit. Das Unternehmen verfolgt einen starken Wachstumskurs mit einer jährlichen Laufzeit von 300 Millionen Dollar bis zum Jahresende.
- Revenue growth of 43% to $286M in 2024
- Turned profitable with $28M net income in 2024
- Reduced debt principal by $236M
- Strong cash position of $203M
- Afrezza approved in India market expansion
- R&D expenses increased 47% to $45.9M
- SG&A expenses rose 17% in Q4 2024
- V-Go product demand decreased
- $1.4M loss from estimated V-Go returns
Insights
MannKind's Q4 and full-year 2024 results demonstrate a company hitting an inflection point in its commercial trajectory and financial health. The 43% year-over-year revenue growth to
The company's financial transformation is further evidenced by its aggressive debt reduction of
MannKind's diversified revenue streams represent a key strength. While Afrezza sales improved through better gross-to-net percentages and increased demand, the substantial royalties from Tyvaso DPI and manufacturing revenue from the United Therapeutics partnership provide stability and reduce reliance on a single product. This multi-product strategy mitigates commercial risk while leveraging the company's proprietary inhalation technology platform.
The pipeline progress presents multiple potential value inflection points in 2025. The planned submission for Afrezza in pediatrics could unlock a substantial new market segment. Meanwhile, the advancement of clofazimine inhalation suspension (MNKD-101) in non-tuberculous mycobacterial lung disease and nintedanib DPI (MNKD-201) demonstrates the platform's versatility across rare respiratory conditions where few effective delivery mechanisms exist.
The
MannKind's 2024 results demonstrate the maturation of their inhalation technology platform across both commercial products and clinical pipeline. The successful INHALE-1 pediatric trial for Afrezza represents a potential breakthrough in pediatric diabetes management, where needle phobia and compliance challenges significantly impact treatment outcomes. With a planned FDA submission in 1H 2025, MannKind could address a critical unmet need in a population where alternative delivery methods have substantial quality-of-life implications.
The American Diabetes Association's formal recognition of inhaled insulin as comparable to injectable insulin in their 2025 Standards of Care marks a important inflection point for Afrezza adoption. This third-party validation effectively removes a significant prescriber hesitation barrier that has historically uptake despite Afrezza's rapid-acting profile and reduced hypoglycemia risk.
MannKind's orphan lung disease programs showcase the versatility of their inhalation expertise beyond diabetes. The progression of clofazimine inhalation suspension (MNKD-101) to a global Phase 3 trial addresses non-tuberculous mycobacterial lung disease, a condition with effective treatments and significant morbidity. The direct-to-lung delivery approach could potentially improve efficacy while reducing systemic exposure compared to oral alternatives, a particularly important consideration given the long treatment durations typically required for NTM infections.
Similarly, the successful Phase 1 completion for nintedanib DPI (MNKD-201) suggests potential advantages over the currently available oral formulation, which is associated with significant gastrointestinal tolerability issues that limit dosing and adherence. An inhaled formulation could potentially maintain efficacy while improving the side effect profile.
The company's manufacturing capabilities for complex inhalation products provide both revenue diversification and technological differentiation. The collaboration with United Therapeutics for Tyvaso DPI manufacturing has become a substantial revenue contributor, growing
With the international approval of Afrezza in India and strategic leadership additions focused on the endocrine business, MannKind is positioning for multi-dimensional growth across geographies and therapeutic areas while maintaining the financial discipline evidenced by their significant debt reduction.
Conference call to provide corporate updates today at 4:30 pm ET
- 2024 revenues of
$286M , +43% v. 2023; 4Q 2024 revenues of$77M , +31% v. 4Q 2023 - 2024 net income of
$28M ; Non-GAAP net income of$68M - 4Q 2024 net income of
$7M ; Non-GAAP net income of$23M - Reduced debt principal by
$236M ; remaining convertible debt of$36M - Year-end 2024 cash, cash equivalents and investments of
$203M - Advanced pipeline:
- Reported primary endpoint of INHALE-1 for Afrezza in pediatrics
- Progressed MNKD-101 to Global Phase 3
- Completed 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
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 in2.5% 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
- Remaining outstanding debt balance of
Fourth Quarter and Full Year 2024 Financial Results
Revenues
| Three Months Ended 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 | % | ||||||||
| Year Ended 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 of24% . For the full year 2024, cost of revenue – collaborations and services was$59.2 million , compared to$41.9 million , an increase of41% . 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 of21% . For the full year 2024, R&D expenses were$45.9 million compared to$31.3 million , an increase of47% . 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 of17% . 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 SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| Three Months Ended December 31, | Year Ended 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 SUBSIDIARIES CONSOLIDATED BALANCE SHEETS | ||||||||
| December 31, 2024 | December 31, 2023 | |||||||
| (In thousands except share and 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, no shares issued or outstanding as of December 31, 2024 or 2023 | — | — | ||||||
| Common stock, 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 | ||||||||||||||||||||||||||||
| Net Income | Basic EPS | Net Income | Basic EPS | Net Income | Basic EPS | Net Income (Loss) | Basic EPS | ||||||||||||||||||||||||
| (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
FAQ
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