MannKind Reports First Quarter 2026 Financial Results and Provides Business Update
- Q1 updates:
- Q1 2026 total revenues of
$90.2M , +15% vs. Q1 2025 - Built out launch infrastructure and aligned field-based teams for upcoming launches
- Settlement of senior convertible notes of
$36.3M
- Q1 2026 total revenues of
- Program updates:
- Afrezza® pediatric indication PDUFA date
May 29, 2026 - Furoscix ReadyFlow™ Autoinjector PDUFA date
July 26, 2026 - Nintedanib DPI (MNKD-201) for IPF advancing into Phase 2; INFLO-2 trial anticipates enrolling first patient in Q2 2026
- Ralinepag DPI (MNKD-1501) announced as collaboration program with United Therapeutics, received additional
$5M to support accelerated development
- Afrezza® pediatric indication PDUFA date
- Conference call and webcast today at
4:30 p.m. ET
“We are making meaningful progress executing our corporate transformation strategy, focused on the expansion and diversification of both our commercial portfolio and development pipeline,” said
Business Update and Upcoming Milestones
Commercial Products
Furoscix
- Furoscix® (furosemide injection) generated
$15.5 million in net sales for the first quarter of 2026; doses dispensed increased by 64% over Q1 2025 - Furoscix ReadyFlow Autoinjector PDUFA target action date of
July 26, 2026 ; if approved, it would be the first product to deliver an IV-equivalent diuretic dose in under 10 seconds
Afrezza
- Afrezza (insulin human) Inhalation Powder generated
$15.3 million in net sales - FDA approved an updated Afrezza label providing starting dose guidance
- Completed pilot phase of INHALE-1st pediatric study evaluating Afrezza for newly diagnosed type 1 diabetes
- New data presented and published from pediatric and adult studies of Afrezza
- Afrezza pediatric indication PDUFA target action date of
May 29, 2026 ; if approved, it would be the first and only inhaled insulin option for children and adolescent patients living with diabetes
Development
Nintedanib DPI (MNKD-201)
- Completed enrollment of Cohort 1 in Phase 1b (INFLO-1) study with no discontinuations or serious adverse events in patients with idiopathic pulmonary fibrosis (IPF); topline data expected in Q3 2026
- Anticipate Phase 2 clinical trial (INFLO-2) in IPF with first patient enrolled in Q2 2026
Ralinepag DPI (MNKD-1501)
- Ralinepag dry powder inhalation (DPI) program to be pursued for pulmonary arterial hypertension by United Therapeutics, followed by pulmonary hypertension associated with interstitial lung disease, IPF and progressive pulmonary fibrosis
- United Therapeutics has made a payment of
$5 million to support the accelerated development of MNKD-1501;MannKind is eligible to receive up to$35 million in development milestone payments and 10% royalties on net sales of any resulting commercial product
Bumetanide DPI (MNKD-701)
- Advancing formulation development of bumetanide DPI for edema associated with congestive heart failure and chronic kidney disease
Corporate Update
- Cash, cash equivalents and investments as of
March 31, 2026 , totaled$134 million - Settlement of the remaining
$36.3 million aggregate principal amount of 2.50% senior convertible notes for$35.5 million in cash and 569,023 shares ofMannKind common stock
First Quarter 2026 Financial Results
Revenues
| Three Months Ended |
|||||||||||||||||||
| 2026 | 2025 | $ Change | % Change | ||||||||||||||||
| Revenues | (Dollars in thousands) | ||||||||||||||||||
| Afrezza | 15,273 | 14,887 | 386 | 3 | % | ||||||||||||||
| Furoscix | 15,493 | — | 15,493 | N/A | |||||||||||||||
| V-Go | 3,141 | 4,086 | (945 | ) | (23 | %) | |||||||||||||
| Collaborations and services | 23,515 | 29,376 | (5,861 | ) | (20 | %) | |||||||||||||
| Royalties | 32,749 | 30,005 | 2,744 | 9 | % | ||||||||||||||
| Total revenues | $ | 90,171 | $ | 78,354 | $ | 11,817 | 15 | % | |||||||||||
Total revenues for the first quarter of 2026 increased compared to the same period in the prior year due to higher revenue from royalties and commercial product sales. Commercial product sales increased primarily due to net sales of Furoscix. The acquisition of scPharma closed on
Operating Expenses and Other Financial Highlights
- Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was
$7.5 million for the first quarter of 2026, compared to$3.8 million for the same period in 2025, an increase of 99%.- The increase is primarily attributable to the inclusion of Furoscix into our product portfolio following the acquisition of scPharma on
October 7, 2025 . Gross margin decreased in the current period due to the inclusion of Furoscix (on-body infusor), which has a lower gross margin than Afrezza.
- The increase is primarily attributable to the inclusion of Furoscix into our product portfolio following the acquisition of scPharma on
- Research and development expenses were
$17.2 million for the first quarter of 2026 compared to$11.0 million for the same period in 2025, an increase of 56%.- The increase was primarily attributable to higher personnel costs following the acquisition of scPharma and higher costs from advancing the development of nintedanib DPI (MNKD-201) studies.
- Selling, general and administrative expenses were
$54.1 million for the first quarter of 2026 compared to$25.0 million for the same period in 2025, an increase of 116%.- The increase was primarily related to costs associated with the promotion and support of Furoscix, as well as higher Afrezza-related expenses including expanding the field-based teams and preparing for a potential pediatric launch.
Conference Call and Webcast
About
With deep expertise in drug-device combinations,
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
Tyvaso DPI is a trademark of United Therapeutics Corporation.
AFREZZA, FUROSCIX,
| Three Months Ended |
||||||||
| 2026 | 2025 | |||||||
| (In thousands except per share data) | ||||||||
| Revenues: | ||||||||
| Commercial product sales | $ | 33,907 | $ | 18,973 | ||||
| Collaborations and services | 23,515 | 29,376 | ||||||
| Royalties | 32,749 | 30,005 | ||||||
| Total revenues | 90,171 | 78,354 | ||||||
| Expenses: | ||||||||
| Cost of goods sold – commercial, excluding amortization of acquired intangible assets | 7,509 | 3,768 | ||||||
| Cost of revenue – collaborations and services | 9,964 | 13,748 | ||||||
| Research and development | 17,231 | 11,022 | ||||||
| Selling, general and administrative | 54,085 | 25,014 | ||||||
| Amortization of acquired intangible assets | 4,367 | — | ||||||
| (Gain) loss on foreign currency transaction | (1,318 | ) | 2,509 | |||||
| Total expenses | 91,838 | 56,061 | ||||||
| (Loss) income from operations | (1,667 | ) | 22,293 | |||||
| Other income (expense): | ||||||||
| Interest income, net | 1,429 | 1,956 | ||||||
| Interest expense | (7,478 | ) | (4,645 | ) | ||||
| Interest expense on liability for sale of future royalties | (2,563 | ) | (3,577 | ) | ||||
| Interest expense on financing liability | (2,393 | ) | (2,410 | ) | ||||
| Loss on settlement of debt | (917 | ) | — | |||||
| Other expense | (2,777 | ) | — | |||||
| Total other expense | (14,699 | ) | (8,676 | ) | ||||
| (Loss) income before income tax expense | (16,366 | ) | 13,617 | |||||
| Income tax expense | 253 | 459 | ||||||
| Net (loss) income | $ | (16,619 | ) | $ | 13,158 | |||
| Net (loss) income per share – basic | $ | (0.05 | ) | $ | 0.04 | |||
| Weighted average shares used to compute net (loss) income per share – basic |
308,267 | 303,481 | ||||||
| Net (loss) income per share – diluted | $ | (0.05 | ) | $ | 0.04 | |||
| Weighted average shares used to compute net (loss) income per share – diluted |
308,267 | 320,897 | ||||||
| MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS |
||||||||
| (In thousands except share and per share data) |
||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 52,834 | $ | 74,882 | ||||
| Short-term investments | 81,027 | 96,464 | ||||||
| Accounts receivable, net | 28,137 | 38,367 | ||||||
| Inventory | 49,166 | 35,313 | ||||||
| Prepaid expenses and other current assets | 39,996 | 46,553 | ||||||
| Total current assets | 251,160 | 291,579 | ||||||
| Restricted cash | 747 | 745 | ||||||
| Long-term investments | — | 5,012 | ||||||
| Property and equipment, net | 82,554 | 82,423 | ||||||
| 67,595 | 67,595 | |||||||
| Developed technology - on-body infusor | 185,708 | 190,027 | ||||||
| IPR&D - ReadyFlow Formulation | 129,600 | 129,600 | ||||||
| Other intangible assets | 5,024 | 5,072 | ||||||
| Other assets | 22,015 | 20,129 | ||||||
| Total assets | $ | 744,403 | $ | 792,182 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 16,144 | $ | 9,034 | ||||
| Accrued expenses and other current liabilities | 58,598 | 64,628 | ||||||
| Senior convertible notes – current | — | 36,280 | ||||||
| Liability for sale of future royalties – current | 14,010 | 14,298 | ||||||
| Contingent consideration - current | 23,877 | 21,132 | ||||||
| Financing liability – current | 10,407 | 10,328 | ||||||
| Deferred revenue – current | 11,525 | 15,331 | ||||||
| Total current liabilities | 134,561 | 171,031 | ||||||
| Liability for sale of future royalties – long term | 136,561 | 136,985 | ||||||
| Financing liability – long term | 92,784 | 93,092 | ||||||
| Deferred revenue – long term | 38,905 | 39,977 | ||||||
| Recognized loss on purchase commitments – long term | 64,635 | 65,952 | ||||||
| Operating lease liability | 10,281 | 10,689 | ||||||
| Contingent consideration – long term | 5,146 | 5,114 | ||||||
| Milestone liabilities | 2,003 | 2,003 | ||||||
| Term loan | 318,722 | 318,361 | ||||||
| Total liabilities | 803,598 | 843,204 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' deficit: | ||||||||
| Undesignated preferred stock, no shares issued or outstanding as of |
— | — | ||||||
| Common stock, 308,907,331 and 307,832,587 shares issued and outstanding as of |
3,089 | 3,078 | ||||||
| Additional paid-in capital | 3,150,295 | 3,141,741 | ||||||
| Accumulated other comprehensive (loss) income | (4 | ) | 115 | |||||
| Accumulated deficit | (3,212,575 | ) | (3,195,956 | ) | ||||
| Total stockholders' deficit | (59,195 | ) | (51,022 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 744,403 | $ | 792,182 | ||||
Non-GAAP Measures
To supplement our condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP net (loss) income and non-GAAP net (loss) income 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 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 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 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 (loss) income and net (loss) income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statement of operations to a non-GAAP presentation:
| Three Months Ended |
||||||||||||||||
| 2026 | 2025 | |||||||||||||||
| Net Income | Basic EPS | Net Income | Basic EPS | |||||||||||||
| GAAP reported net (loss) income | $ | (16,619 | ) | $ | (0.05 | ) | $ | 13,158 | 0.04 | |||||||
| Non-GAAP adjustments: | ||||||||||||||||
| Stock compensation | 6,455 | 0.02 | 5,385 | 0.02 | ||||||||||||
| Interest expense on liability for sale of future royalties | 2,563 | 0.01 | 3,577 | 0.01 | ||||||||||||
| Sold portion of royalty revenue(1) | (3,275 | ) | (0.01 | ) | (3,000 | ) | (0.01 | ) | ||||||||
| (Gain) loss on foreign currency transaction | (1,318 | ) | 0.00 | 2,509 | 0.01 | |||||||||||
| Amortization of intangible assets acquired | 4,367 | 0.01 | — | — | ||||||||||||
| Loss on settlement of debt | 917 | 0.00 | — | — | ||||||||||||
| Non-GAAP adjusted net (loss) income | $ | (6,910 | ) | $ | (0.02 | ) | $ | 21,629 | $ | 0.07 | ||||||
| Weighted average shares used to compute net (loss) income per share – basic | 308,267 | 303,481 | ||||||||||||||
| (1) | Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three months ended |
MannKind Contacts: Investor RelationsKate Miranda Email: ir@mnkd.com Media RelationsChristie Iacangelo Email: media@mnkd.com
Source: MannKind