MannKind Corporation Reports First Quarter 2025 Financial Results and Provides Business Update
Conference call to provide corporate updates today at
- 1Q 2025 revenues of
$78M , +18% v. 1Q 2024 - 1Q 2025 net income of
$13M , + 24% v. 1Q 2024 - 1Q 2025 non-GAAP net income of
$22M , +43% v. 1Q 2024 - Advanced pipeline:
- Expect to submit sBLA for Afrezza® in pediatric patients in mid-2025
- MNKD-101: NTM global Phase 3 trial enrollment on track for interim analysis
- MNKD-201: Expect to continue to next phase of global development in 2H 2025
“The first quarter was marked by strong year-over-year NRx growth in Afrezza, substantial Tyvaso DPI-related revenues and continued progress in our Phase 3 trial of MNKD-101 (clofazimine inhalation suspension) in NTM lung disease,” said
1Q 2025 Business Update and Upcoming Milestones
Afrezza INHALE-1 Pediatric Phase 3 clinical trial
- Met with the FDA to obtain guidance on a supplemental Biologics License Application (sBLA) for the pediatric population expected to be filed in mid-2025
- Topline results from the full study pediatric data set with the safety extension expected in 2Q 2025
Clofazimine Inhalation Suspension (MNKD-101) Phase 3 global clinical trial (ICON-1)
- 85% of anticipated sites have been activated in five countries (
U.S. ,Japan ,Australia ,South Korea ,Taiwan ) - 55 patients randomized in four countries (
U.S. ,Japan ,Australia ,South Korea ) - Expect to meet the interim enrollment target of 100 patients by YE 2025
Nintedanib DPI (MNKD-201)
- Planning to advance into the next phase of global development in 2H 2025
Endocrine Business Unit
- Afrezza INHALE-3 Phase 4 30-week data published in two articles in Diabetes Technology & Therapeutics
- Label application to update initial Afrezza conversion dose submitted to FDA; currently under review
- Afrezza performance 1Q 2025 compared to 1Q 2024: 20% NRx growth; 14% TRx growth
Corporate and Financial
- Cash, cash equivalents and investments as of
March 31, 2025 totaled$198 million - Majority of revenue and future pipeline programs are derived from
MannKind's U.S. -based manufacturing facility inDanbury, CT , mitigating potential tariff exposure
First Quarter 2025 Financial Results
Revenues
| Three Months Ended |
||||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Revenues | (Dollars in thousands) | |||||||||||||||
| Royalties | $ | 30,005 | $ | 22,651 | $ | 7,354 | 32 | % | ||||||||
| Collaborations and services | 29,376 | 24,848 | $ | 4,528 | 18 | % | ||||||||||
| Afrezza | 14,887 | 14,438 | $ | 449 | 3 | % | ||||||||||
| V-Go | 4,086 | 4,326 | $ | (240 | ) | (6 | %) | |||||||||
| Total revenues | $ | 78,354 | $ | 66,263 | $ | 12,091 | 18 | % | ||||||||
Total revenues increased
Operating Expenses and Other Financial Highlights
- Research and development expenses were
$11.0 million for the first quarter of 2025 compared to$10.0 million for the same period in 2024, an increase of 10%. The increase was primarily attributable to increased expenditures for development activities, including a Phase 3 clinical study for MNKD-101, clinical production scale up for MNKD-201, and personnel costs primarily due to additional headcount as a result ofMannKind's transaction with Pulmatrix, Inc. in the third quarter of 2024, which bolstered our research capabilities and capacity. - Selling, general and administrative expenses were
$25.0 million for the first quarter of 2025 compared to$22.3 million for the same period in 2024, an increase of 12%. This increase was primarily attributable to increases in headcount, personnel costs and Afrezza promotional costs, partially offset by a loss of$1.2 million in the prior year period for estimated returns associated with sales of V-Go that pre-datedMannKind's acquisition of the product. - For the first quarter of 2025,
MannKind reported net income of$13.2 million , or$0.04 earnings per share – basic, compared to net income of$10.6 million , or$0.04 earnings per share – basic, for the same period in 2024, an increase in net income of$2.5 million , or 24%. - For the first quarter of 2025,
MannKind reported non-GAAP net income of$21.6 million , or$0.07 earnings per share – basic, compared to non-GAAP net income of$15.1 million , or$0.06 earnings per share – basic, for the same period in 2024, an increase in net income of$6.5 million , or 43%. For a reconciliation of GAAP reported net income and net income per share for basic weighted average shares to these non-GAAP measures, please see Non-GAAP Measures below.
Conference Call
About
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
Tyvaso DPI is a trademark of United Therapeutics Corporation.
AFREZZA,
| MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
| Three Months Ended |
||||||||
| 2025 | 2024 | |||||||
| (In thousands except per share data) | ||||||||
| Revenues: | ||||||||
| Commercial product sales | $ | 18,973 | $ | 18,764 | ||||
| Collaborations and services | 29,376 | 24,848 | ||||||
| Royalties | 30,005 | 22,651 | ||||||
| Total revenues | 78,354 | 66,263 | ||||||
| Expenses: | ||||||||
| Cost of goods sold – commercial | 3,768 | 3,819 | ||||||
| Cost of revenue – collaborations and services | 13,748 | 14,779 | ||||||
| Research and development | 11,022 | 10,013 | ||||||
| Selling, general and administrative | 25,014 | 22,329 | ||||||
| Loss (gain) on foreign currency transaction | 2,509 | (1,399 | ) | |||||
| Total expenses | 56,061 | 49,541 | ||||||
| Income from operations | 22,293 | 16,722 | ||||||
| Other income (expense): | ||||||||
| Interest income, net | 1,956 | 3,434 | ||||||
| Interest expense on liability for sale of future royalties | (3,577 | ) | (4,248 | ) | ||||
| Interest expense on financing liability | (2,410 | ) | (2,447 | ) | ||||
| Interest expense | (4,645 | ) | (2,567 | ) | ||||
| Total other expense | (8,676 | ) | (5,828 | ) | ||||
| Income before income tax expense | 13,617 | 10,894 | ||||||
| Income tax expense | 459 | 264 | ||||||
| Net income | $ | 13,158 | $ | 10,630 | ||||
| Net income per share – basic | $ | 0.04 | $ | 0.04 | ||||
| Weighted average shares used to compute net income per share – basic | 303,481 | 270,356 | ||||||
| Net income per share – diluted | $ | 0.04 | $ | 0.04 | ||||
| Weighted average shares used to compute net income per share – diluted | 320,897 | 324,733 | ||||||
| MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS |
||||||||
| (In thousands except share and per share data) |
||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 47,312 | $ | 46,339 | ||||
| Short-term investments | 134,229 | 150,917 | ||||||
| Accounts receivable, net | 28,900 | 11,804 | ||||||
| Inventory | 28,892 | 27,886 | ||||||
| Prepaid expenses and other current assets | 34,404 | 31,360 | ||||||
| Total current assets | 273,737 | 268,306 | ||||||
| Restricted cash | 739 | 737 | ||||||
| Long-term investments | 16,681 | 5,482 | ||||||
| Property and equipment, net | 83,781 | 85,365 | ||||||
| 1,931 | 1,931 | |||||||
| Other intangible assets | 5,217 | 5,265 | ||||||
| Other assets | 28,055 | 26,757 | ||||||
| Total assets | $ | 410,141 | $ | 393,843 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,041 | $ | 6,792 | ||||
| Accrued expenses and other current liabilities | 40,103 | 40,293 | ||||||
| Senior convertible notes – current | 36,109 | — | ||||||
| Liability for sale of future royalties – current | 12,802 | 12,283 | ||||||
| Financing liability – current | 10,125 | 10,062 | ||||||
| Deferred revenue – current | 11,757 | 12,407 | ||||||
| Total current liabilities | 115,937 | 81,837 | ||||||
| Liability for sale of future royalties – long term | 137,420 | 137,362 | ||||||
| Financing liability – long term | 93,665 | 93,877 | ||||||
| Deferred revenue – long term | 47,360 | 51,160 | ||||||
| Recognized loss on purchase commitments – long term | 60,713 | 58,204 | ||||||
| Operating lease liability | 11,141 | 11,645 | ||||||
| Milestone liabilities | 2,523 | 2,523 | ||||||
| Senior convertible notes | — | 36,051 | ||||||
| Total liabilities | 468,759 | 472,659 | ||||||
| Stockholders' deficit: | ||||||||
| Undesignated preferred stock, |
— | — | ||||||
| Common stock, |
3,039 | 3,029 | ||||||
| Additional paid-in capital | 3,125,830 | 3,118,865 | ||||||
| Accumulated other comprehensive income | 1,174 | 1,109 | ||||||
| Accumulated deficit | (3,188,661 | ) | (3,201,819 | ) | ||||
| Total stockholders' deficit | (58,618 | ) | (78,816 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 410,141 | $ | 393,843 | ||||
Non-GAAP Measures
To supplement
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 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 Quarterly Report on Form 10-Q 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 and net income per share ("EPS") for basic weighted average shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation:
| Three Months Ended |
|||||||||||||||
| 2025 | 2024 | ||||||||||||||
| Net Income | Basic EPS | Net Income | Basic EPS | ||||||||||||
| (In thousands except per share data) | |||||||||||||||
| GAAP reported net income | $ | 13,158 | $ | 0.04 | $ | 10,630 | $ | 0.04 | |||||||
| Non-GAAP adjustments: | |||||||||||||||
| Sold portion of royalty revenue (1) | (3,000 | ) | (0.01 | ) | (2,265 | ) | (0.01 | ) | |||||||
| Interest expense on liability for sale of future royalties | 3,577 | 0.01 | 4,248 | 0.03 | |||||||||||
| Stock compensation | 5,385 | 0.02 | 3,885 | 0.01 | |||||||||||
| Loss (gain) on foreign currency transaction | 2,509 | 0.01 | (1,399 | ) | (0.01 | ) | |||||||||
| Non-GAAP adjusted net income | $ | 21,629 | $ | 0.07 | $ | 15,099 | $ | 0.06 | |||||||
| Weighted average shares used to compute net income per share – basic | 303,481 | 270,356 | |||||||||||||
_________________
| (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 RelationsAna Kapor (818) 661-5000 Email: ir@mnkd.com Media RelationsChristie Iacangelo (818) 292-3500 Email: media@mnkd.com
Source: MannKind