MannKind Reports Third Quarter 2026 Financial Results and Provides Business Update
- Q3 2026 total revenues of
$101.9 million , +24% vs. Q3 2025 - Q3 2026 commercial product revenue of
$45.0 million , +102% vs. Q3 2025- Furoscix ReadyFlow™ was approved and shipments commenced mid-September
- Rapid adoption of Furoscix ReadyFlow, making up approximately 75% of the current weekly Furoscix shipments
- Afrezza® pediatric launch accounts for an approximately 80% increase in average monthly new-to-brand prescriptions in Q3 vs. Q2 2026
- Pipeline Advancements
- Reported positive Phase 1b INFLO-1 results, demonstrating tolerability of nintedanib DPI and clinical validation of Technosphere DPI technology in IPF; global Phase 2 trial underway
- Conference call and webcast today at
4:30 p.m. ET
“The third quarter marked an important transition for
Business Update
Commercial Products
Furoscix
- Furoscix® generated
$22.4 million in net revenue for the third quarter of 2026, with Furoscix ReadyFlow shipments commencing in mid-September - Approximately 75% of Furoscix shipments transitioned to ReadyFlow by late October, demonstrating rapid adoption following launch
- Achieved record monthly prescribers and prescriptions in September, reflecting continued growth in Furoscix utilization
Afrezza
- Afrezza® generated
$19.3 million in net sales for the third quarter of 2026 - Total prescriptions increased approximately 17% compared with Q2 2026, driven by strong early uptake following the pediatric launch
- All 60 priority pediatric institutions have prescribed Afrezza, with approximately 2,000 pediatric patients treated since launch
Development
Nintedanib DPI (MNKD-201)
- Positive Phase 1b INFLO-1 results demonstrated tolerability of nintedanib DPI, validating the Technosphere® DPI platform in IPF
- Advancing MNKD-201 into global Phase 2 trial
Ralinepag DPI (MNKD-1501)
- Formulation work completed; United Therapeutics plans to pursue clinical development
- Anticipate earning
$15 million in milestone payments in 2027
Inhaled GLP-1 Program
- Entered into a licensing and collaboration agreement with Rose Pharma to develop an inhaled rapid-acting, short-duration GLP-1 for weight management
Corporate Update
- Cash, cash equivalents and investments as of
September 30, 2026 , totaled$96.6 million - Closed
$50 million private placement onJuly 24, 2026 ; proceeds funded the$45 million CVR payment triggered by the FDA approval of Furoscix ReadyFlow
Third Quarter 2026 Financial Results
Revenues
| Three Months Ended |
|||||||||||||
| 2026 | 2025 | $ Change |
% Change |
||||||||||
| Revenues | (Dollars in thousands) |
||||||||||||
| Afrezza | 19,349 | 18,493 | 856 | 5 | % | ||||||||
| Furoscix | 22,376 | — | 22,376 | N/A | |||||||||
| V-Go | 3,277 | 3,812 | (535 | ) | (14 | %) | |||||||
| Collaborations and services | 19,405 | 26,506 | (7,101 | ) | (27 | %) | |||||||
| Royalties | 37,463 | 33,319 | 4,144 | 12 | % | ||||||||
| Total revenues | $ | 101,870 | $ | 82,130 | $ | 19,740 | 24 | % | |||||
Total revenues for the third quarter of 2026 increased compared to the same period in the prior year primarily due to the addition of Furoscix to our product portfolio following the
Operating Expenses and Other Financial Highlights
- Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was
$11.2 million for the three months endedSeptember 30, 2026 , compared to$4.5 million for the same period in 2025.- The increase is primarily attributable to the inclusion of Furoscix into our product portfolio following the acquisition of scPharma in
October 2025 . The Furoscix on-body infusor has a lower gross margin percentage than Afrezza which resulted in a decrease in gross margin in the current period.
- The increase is primarily attributable to the inclusion of Furoscix into our product portfolio following the acquisition of scPharma in
- Research and development expenses were
$14.4 million for the three months endedSeptember 30, 2026 , compared to$14.1 million for the same period in 2025, an increase of 2%.- The increase was primarily attributable to the development of Furoscix ReadyFlow, higher personnel costs following the acquisition of scPharma, and increased clinical development costs for MNKD-201. These increases were partially offset by lower clinical development expenses resulting from the discontinuation of the ICoN-1 clinical study for MNKD-101 and the completion of the Afrezza pediatric study.
- Selling, general and administrative expenses were
$61.4 million for the three months endedSeptember 30, 2026 , compared to$29.1 million for the same period in 2025, an increase of 111%.- The increase was primarily attributable to costs associated with the promotion and support of Furoscix, which was acquired from scPharma in
October 2025 , expansion of our field-based teams, and launch activities related to Furoscix ReadyFlow and the pediatric indication for Afrezza.
- The increase was primarily attributable to costs associated with the promotion and support of Furoscix, which was acquired from scPharma in
Nine Months Ended
Revenues
| Nine Months Ended |
|||||||||||||
| 2026 | 2025 | $ Change |
% Change |
||||||||||
| Revenues | (Dollars in thousands) |
||||||||||||
| Afrezza | 51,643 | 51,709 | (66 | ) | (0 | %) | |||||||
| Furoscix | 60,061 | — | 60,061 | N/A | |||||||||
| V-Go | 9,188 | 12,023 | (2,835 | ) | (24 | %) | |||||||
| Collaborations and services | 77,941 | 78,727 | (786 | ) | (1 | %) | |||||||
| Royalties | 102,583 | $ | 94,552 | $ | 8,031 | 8 | % | ||||||
| Total revenues | $ | 301,416 | $ | 237,011 | $ | 64,405 | 27 | % | |||||
Total revenues for the nine months ended
Operating Expenses and Other Financial Highlights
- Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was
$33.1 million for the nine months endedSeptember 30, 2026 , compared to$12.9 million for the same period in 2025.- The increase is primarily attributable to the inclusion of Furoscix into our product portfolio following the acquisition of scPharma in
October 2025 . The Furoscix on-body infusor has a lower gross margin percentage than Afrezza which resulted in a decrease in gross margin in the current period.
- The increase is primarily attributable to the inclusion of Furoscix into our product portfolio following the acquisition of scPharma in
- Research and development expenses were
$49.6 million for the nine months endedSeptember 30, 2026 , compared to$38.8 million for the same period in 2025, an increase of 28%.- The increase was primarily attributable to the development of Furoscix ReadyFlow, higher personnel costs following the acquisition of scPharma, and increased clinical development costs for MNKD-201. These increases were partially offset by lower clinical development expenses resulting from the discontinuation of the ICoN-1 clinical study for MNKD-101 and the completion of the Afrezza pediatric study.
- Selling, general and administrative expenses were
$173.8 million for the nine months endedSeptember 30, 2026 , compared to$85.7 million for the same period in 2025, an increase of 103%.- The increase was primarily attributable to costs associated with the promotion and support of Furoscix, expansion of our field-based teams, and launch activities related to Furoscix ReadyFlow and the pediatric indication for Afrezza.
Conference Call and Webcast
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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 the anticipated growth potential for Furoscix, including as a major commercial brand; the development plans for ralinepag DPI and the expected timing for milestone payments related thereto; the potential benefits of and opportunities for MannKind’s products and product candidates; and expectations regarding MannKind’s ongoing and planned clinical trials and nonclinical studies, including the ongoing Phase 2 INFLO-2 trial. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal,” “potential,” “prepare,” “opportunity” 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; manufacturing risks; market adoption risks; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, being filed with the SEC later today. 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, and V-GO are registered trademarks, and Furoscix ReadyFlow is a trademark of MannKind Corporation.
| MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
| Three Months Ended |
Nine Months Ended |
|||||||||||||||
| 2026 |
2025 |
2026 |
2025 |
|||||||||||||
| (In thousands except per share data) |
||||||||||||||||
| Revenues: | ||||||||||||||||
| Commercial product sales | $ | 45,002 | $ | 22,305 | $ | 120,892 | $ | 63,732 | ||||||||
| Collaborations and services | 19,405 | 26,506 | 77,941 | 78,727 | ||||||||||||
| Royalties | 37,463 | 33,319 | 102,583 | 94,552 | ||||||||||||
| Total revenues | 101,870 | 82,130 | 301,416 | 237,011 | ||||||||||||
| Expenses: | ||||||||||||||||
| Cost of goods sold – commercial, excluding amortization of acquired intangible assets |
11,213 | 4,498 | 33,130 | 12,873 | ||||||||||||
| Cost of revenue – collaborations and services | 12,299 | 15,705 | 37,393 | 45,414 | ||||||||||||
| Research and development | 14,360 | 14,063 | 49,592 | 38,760 | ||||||||||||
| Selling, general and administrative | 61,412 | 29,088 | 173,801 | 85,724 | ||||||||||||
| Amortization of acquired intangible assets | 5,160 | — | 13,895 | — | ||||||||||||
| (Gain) loss on foreign currency transaction | (391 | ) | (120 | ) | (2,195 | ) | 7,752 | |||||||||
| Total expenses | 104,053 | 63,234 | 305,616 | 190,523 | ||||||||||||
| (Loss) income from operations | (2,183 | ) | 18,896 | (4,200 | ) | 46,488 | ||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1,090 | 2,628 | 3,541 | 6,416 | ||||||||||||
| Interest expense | (7,642 | ) | (1,364 | ) | (27,015 | ) | (6,294 | ) | ||||||||
| Interest expense on liability for sale of future royalties | (501 | ) | (3,514 | ) | (3,573 | ) | (10,564 | ) | ||||||||
| Interest expense on financing liability | (2,434 | ) | (2,456 | ) | (7,241 | ) | (7,299 | ) | ||||||||
| Impairment of available-for-sale investment | — | (6,409 | ) | — | (6,409 | ) | ||||||||||
| Loss on settlement of debt | — | — | (917 | ) | — | |||||||||||
| Other expense, net | (11,503 | ) | — | (19,271 | ) | — | ||||||||||
| Total other expense, net | (20,990 | ) | (11,115 | ) | (54,476 | ) | (24,150 | ) | ||||||||
| (Loss) income before income tax expense (benefit) | (23,173 | ) | 7,781 | (58,676 | ) | 22,338 | ||||||||||
| Income tax expense (benefit) | 51 | (204 | ) | 198 | 527 | |||||||||||
| Net (loss) income | $ | (23,224 | ) | $ | 7,985 | $ | (58,874 | ) | $ | 21,811 | ||||||
| Net (loss) income per share – basic | $ | (0.07 | ) | $ | 0.03 | $ | (0.19 | ) | $ | 0.07 | ||||||
| Weighted average shares used to compute net (loss) income per share – basic |
320,182 | 306,806 | 312,722 | 305,093 | ||||||||||||
| Net (loss) income per share – diluted | $ | (0.07 | ) | $ | 0.03 | $ | (0.19 | ) | $ | 0.07 | ||||||
| Weighted average shares used to compute net (loss) income per share – diluted |
320,182 | 311,638 | 312,722 | 313,339 | ||||||||||||
| MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS |
||||||||
| (In thousands except share and per share data) |
||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 41,276 | $ | 74,882 | ||||
| Short-term investments | 55,333 | 96,464 | ||||||
| Accounts receivable, net | 41,034 | 38,367 | ||||||
| Inventory | 48,469 | 35,313 | ||||||
| Prepaid expenses and other current assets | 54,364 | 46,553 | ||||||
| Total current assets | 240,476 | 291,579 | ||||||
| Restricted cash | 749 | 745 | ||||||
| Property and equipment, net | 86,371 | 82,423 | ||||||
| 67,595 | 67,595 | |||||||
| Developed technology - Furoscix | 305,877 | 190,027 | ||||||
| IPR&D - ReadyFlow Formulation | — | 129,600 | ||||||
| Other intangible assets | 4,927 | 5,072 | ||||||
| Other assets | 16,621 | 20,129 | ||||||
| Long-term investments | — | 5,012 | ||||||
| Total assets | $ | 722,616 | $ | 792,182 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 14,383 | $ | 9,034 | ||||
| Accrued expenses and other current liabilities | 59,593 | 64,628 | ||||||
| Liability for sale of future royalties – current | 14,573 | 14,298 | ||||||
| Financing liability – current | 10,565 | 10,328 | ||||||
| Deferred revenue – current | 9,410 | 15,331 | ||||||
| Contingent consideration – current | — | 21,132 | ||||||
| Senior convertible notes – current | — | 36,280 | ||||||
| Total current liabilities | 108,524 | 171,031 | ||||||
| Liability for sale of future royalties – long term | 130,026 | 136,985 | ||||||
| Financing liability – long term | 92,231 | 93,092 | ||||||
| Deferred revenue – long term | 34,809 | 39,977 | ||||||
| Recognized loss on purchase commitments – long term | 63,720 | 65,952 | ||||||
| Operating lease liability | 9,177 | 10,689 | ||||||
| Milestone liabilities | 1,580 | 2,003 | ||||||
| Term loan | 319,447 | 318,361 | ||||||
| Other long term liabilities | 368 | — | ||||||
| Contingent consideration – long term | — | 5,114 | ||||||
| Total liabilities | 759,882 | 843,204 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' deficit: | ||||||||
| Undesignated preferred stock, no shares issued or outstanding as of |
— | — | ||||||
| Common stock, 321,633,894 and 307,832,587 shares issued and outstanding as of September 30, 2026 and |
3,216 | 3,078 | ||||||
| Additional paid-in capital | 3,214,437 | 3,141,741 | ||||||
| Accumulated other comprehensive (loss) income | (88 | ) | 115 | |||||
| Accumulated deficit | (3,254,831 | ) | (3,195,956 | ) | ||||
| Total stockholders' deficit | (37,266 | ) | (51,022 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 722,616 | $ | 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 |
Nine Months Ended |
|||||||||||||||||||||||||||||||||||||||||
| 2026 |
2025 |
2026 |
2025 |
|||||||||||||||||||||||||||||||||||||||
| Net Loss |
Basic EPS |
Net Income |
Basic EPS |
Net Loss |
Basic EPS |
Net Income |
Basic EPS |
|||||||||||||||||||||||||||||||||||
| GAAP reported net (loss) income | $ | (23,224 | ) | $ | (0.07 | ) | $ | 7,985 | 0.03 | $ | (58,874 | ) | $ | (0.19 | ) | $ | 21,811 | $ | 0.07 | |||||||||||||||||||||||
| Non-GAAP adjustments: | ||||||||||||||||||||||||||||||||||||||||||
| Stock compensation | 6,444 | 0.02 | 4,318 | 0.01 | 23,125 | 0.07 | 17,223 | 0.06 | ||||||||||||||||||||||||||||||||||
| Interest expense on liability for sale of future royalties |
501 | 0.00 | 3,514 | 0.01 | 3,573 | 0.01 | 10,564 | 0.03 | ||||||||||||||||||||||||||||||||||
| Sold portion of royalty revenue (1) | (3,746 | ) | (0.01 | ) | (3,332 | ) | (0.01 | ) | (10,258 | ) | (0.03 | ) | (9,455 | ) | (0.03 | ) | ||||||||||||||||||||||||||
| (Gain) loss on foreign currency transaction |
(391 | ) | 0.00 | (120 | ) | 0.00 | (2,195 | ) | (0.01 | ) | 7,752 | 0.03 | ||||||||||||||||||||||||||||||
| Amortization of intangible assets acquired | 5,160 | 0.01 | — | — | 13,895 | 0.05 | — | — | ||||||||||||||||||||||||||||||||||
| Expense related to contingent consideration | 11,641 | 0.04 | — | — | 19,409 | 0.07 | — | — | ||||||||||||||||||||||||||||||||||
| Loss on settlement of debt | — | — | — | — | 917 | 0.00 | — | — | ||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||
| Non-GAAP adjusted net (loss) income | $ | (3,615 | ) | $ | (0.01 | ) | $ | 22,447 | $ | 0.07 | $ | (10,408 | ) | $ | (0.03 | ) | $ | 57,977 | $ | 0.19 | ||||||||||||||||||||||
| Weighted average shares used to compute net (loss) income per share – basic | 320,182 | 306,806 | 312,722 | 305,093 | ||||||||||||||||||||||||||||||||||||||
| (1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the three and nine months ended |
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MannKind Contacts: Investor RelationsKate Miranda Email: ir@mnkd.com Media RelationsChristie Iacangelo Email: media@mnkd.com
Source: MannKind