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EXHIBIT 99.1

MANNKIND CORPORATION REPORTS
SECOND QUARTER 2025 FINANCIAL RESULTS AND
PROVIDES BUSINESS UPDATE

Conference call today at 9:00 am ET

 

2Q 2025 revenues of $76.5M, +6% v. 2Q 2024
YTD 2025 revenues of $154.9M, +12% v. YTD 2024
Advanced pipeline:
o
Submitted sBLA for Afrezza® in pediatric population
o
MNKD-101: NTM global Phase 3 trial (ICoN-1) enrollment ahead of schedule
o
MNKD-201: Plan to initiate Phase 2 clinical trial for IPF by YE 2025

DANBURY, Conn. and WESTLAKE VILLAGE, Calif. August 6, 2025 (Globe Newswire) — MannKind Corporation (Nasdaq: MNKD) today reported financial results for the second quarter 2025 and provided a business update.

“The submission of our supplemental Biologics License Application (sBLA) for Afrezza in pediatric patients is a meaningful milestone for MannKind and people living with diabetes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “In our orphan lung pipeline, we’re encouraged by the robust enrollment progress in the ICoN-1 trial of inhaled clofazimine for NTM lung disease, and we are excited to advance nintedanib DPI into Phase 2 for IPF.”

2Q 2025 Business Update and Upcoming Milestones

Afrezza INHALE-1 Pediatric Phase 3 clinical trial

Submitted an sBLA for Afrezza® (insulin human) Inhalation Powder in the pediatric population with a review acceptance decision expected in early 4Q 2025
The filing is based on data from the INHALE-1 study of Afrezza in children and adolescents (aged 4-17 years)
Topline results from the full pediatric study including the safety extension have been submitted for presentation at a medical meeting in 2H 2025

Inhaled Clofazimine (MNKD-101) Phase 3 global clinical trial (ICoN-1)

Enrollment ahead of schedule; expect to achieve interim enrollment target of 100 patients in early 4Q 2025

Nintedanib DPI (MNKD-201)

Expect to initiate Phase 2 clinical trial for IPF by YE 2025

Endocrine Business Unit

Presented data from recent pediatric and adult studies of Afrezza affirming positive outcomes utilizing inhaled insulin at the American Diabetes Association’s 85th Scientific Sessions in June
Application submitted to FDA to update labeling regarding initial Afrezza conversion dose; decision expected 4Q 2025
Afrezza performance 2Q 2025 compared to 2Q 2024: $18.3 million v. $16.3 million, a 13% increase

Corporate and Financial

Cash, cash equivalents and investments as of June 30, 2025 totaled $201.2 million
Majority of revenue and future pipeline programs are derived from MannKind's U.S.-based manufacturing facility in Danbury, CT, mitigating potential tariff exposure

Second Quarter 2025 Financial Results

Revenues

 

 

Three Months
Ended June 30,

 

 

 

2025

 

 

2024

 

 

$ Change

 

 

% Change

 

Revenues

 

(Dollars in thousands)

 

Royalties

 

$

31,228

 

 

$

25,592

 

 

$

5,636

 

 

 

22

%

Collaborations and services

 

 

22,845

 

 

 

26,014

 

 

$

(3,169

)

 

 

(12

%)

Afrezza

 

 

18,329

 

 

 

16,289

 

 

$

2,040

 

 

 

13

%

V-Go

 

 

4,125

 

 

 

4,491

 

 

$

(366

)

 

 

(8

%)

Total revenues

 

$

76,527

 

 

$

72,386

 

 

$

4,141

 

 

 

6

%

 

Total revenues increased $4.1 million, or 6% in the second quarter of 2025 compared to the same period in the prior year. Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI® and higher commercial product revenue for Afrezza, mainly due to higher demand and price and a lower rate of sales deductions. The overall increase in revenue was partially offset by a decrease in collaboration and services revenue due to the net impact of one-time items. There was also a decrease in net revenue for V-Go® due to lower demand, offset by decreased sales deductions due to lower rebates on certain commercial contracts.

Operating Expenses and Other Financial Highlights

Research and development expenses increased by $1.9 million, or 16%, for the three months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in the ICoN-1 study for MNKD-101, clinical production scale up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction completed in the third quarter of 2024, which bolstered research capabilities and capacity. These increases were partially offset by the completion of the Company’s Afrezza post-marketing clinical study (INHALE-3) and Phase 1 MNKD-201 studies in 2024, as well as lower costs as the Company closed out its Afrezza pediatric clinical study (INHALE-1).
Selling, general and administrative expenses increased by $7.5 million, or 31%, for the three months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily driven by higher headcount and personnel-related costs, including deploying a medical science liaison team, and higher Afrezza promotional costs.
Loss on foreign currency transaction was $5.4 million for the three months ended June 30, 2025, compared to a gain of $0.5 million for the same period in the prior year. This was due to fluctuations in U.S. dollar to Euro exchange rates. Under the Company’s Insulin Supply Agreement with Amphastar, payment obligations for future purchases are denominated in Euros. The Company records the foreign currency transaction impact of the U.S. dollar to Euro exchange rate associated with the future purchase commitments.

For the second quarter of 2025, the Company reported net income of $0.7 million, or $0.00 earnings per share – basic, compared to net loss of $2.0 million, or $0.01 loss per share – basic, for the same period in 2024, an increase in net income of $2.7 million.
For the second quarter of 2025, the Company reported non-GAAP net income of $13.9 million, or $0.05 earnings per share – basic, compared to non-GAAP net income of $14.3 million, or $0.05 earnings per share – basic, for the same period in 2024, a decrease in net income of $0.4 million, or 3%. 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.

Six Months Ended June 30, 2025

Revenues

 

 

Six Months
Ended June 30,

 

 

 

2025

 

 

2024

 

 

$ Change

 

 

% Change

 

Revenues

 

(Dollars in thousands)

 

Royalties

 

$

61,233

 

 

$

48,243

 

 

$

12,990

 

 

 

27

%

Collaborations and services

 

 

52,221

 

 

 

50,862

 

 

$

1,359

 

 

 

3

%

Afrezza

 

 

33,216

 

 

 

30,727

 

 

$

2,489

 

 

 

8

%

V-Go

 

 

8,211

 

 

 

8,817

 

 

$

(606

)

 

 

(7

%)

Total revenues

 

$

154,881

 

 

$

138,649

 

 

$

16,232

 

 

 

12

%

Total revenues increased $16.2 million, or 12%, for the six months ended June 30, 2025 compared to the same period in the prior year. Revenue increases were driven by royalties earned on increased net sales of Tyvaso DPI® and higher revenue from collaborations and services due to increased product sold to United Therapeutics Corporation. Commercial product revenue increased for Afrezza, mainly due to higher demand and price, partially offset by a decrease in net revenue for V-Go® due to lower demand, offset by decreased sales deductions due to lower rebates on certain commercial contracts.

Operating Expenses and Other Financial Highlights

Research and development expenses increased by $2.9 million, or 13%, for the six months ended June 30, 2025 compared to the same period in the prior year. The increase was primarily attributable to continued patient enrollment in ICoN-1 study, clinical production scale up for MNKD-201, and personnel costs primarily due to additional headcount as a result of the Pulmatrix transaction completed in the third quarter of 2024, which bolstered research capabilities and capacity. These increases were partially offset by the completion of the INHALE-3 study, the Phase 1 and toxicology studies for MNKD-201 in 2024 as well as lower costs for INHALE-1 as the study was closed out in the second quarter of 2025.
Selling, general and administrative expenses increased by $10.2 million, or 22%, for the six months ended June 30, 2025 compared to the same period in the prior year. The increase was largely attributable to higher headcount and personnel-related expenses as well as deploying a medical science liaison team, and Afrezza promotional costs. These increases were partially offset by $1.4 million charge recorded in the prior year period for estimated returns associated with sales of V-Go that pre-dated the Company’s acquisition of the product.
Loss on foreign currency transactions was $7.9 million for the six months ended June 30, 2025, compared to a gain of $1.9 million for the same period in the prior year, due to fluctuations in U.S. dollar to Euro exchange rates related to the future purchase commitments.
For the six months ended June 30, 2025, The Company reported net income of $13.8 million, or $0.05 earnings per share – basic, compared to net income of $8.6 million, or $0.03 earnings per share – basic, for the same period in 2024, an increase in net income of $5.2 million.

For the six months ended June 30, 2025, the Company reported non-GAAP net income of $35.5 million, or $0.12 earnings per share – basic, compared to non-GAAP net income of $29.4 million, or $0.11 earnings per share – basic, for the same period in 2024, an increase in net income of $6.1 million, or 21%. 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

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.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 patient enrolment timelines for MNKD-101, the initiation of a Phase 2 study of MNKD-201, the expected timing for trial results and regulatory events related to Afrezza, and potential tariff exposure. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “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 the regulatory review process; manufacturing risks; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its most recently filed Quarterly Report 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 Contacts:

Investor Relations


Ana Kapor

(818) 661-5000

Email: ir@mnkd.com

 

Media Relations

Christie Iacangelo

(818) 292-3500

Email: media@mnkd.com

 


MANNKIND CORPORATION AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

Three Months
Ended June 30,

 

 

Six Months
Ended June 30,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

 

(In thousands except per share data)

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Commercial product sales

 

$

22,454

 

 

$

20,780

 

 

$

41,427

 

 

$

39,544

Collaborations and services

 

 

22,845

 

 

 

26,014

 

 

 

52,221

 

 

 

50,862

Royalties

 

 

31,228

 

 

 

25,592

 

 

 

61,233

 

 

 

48,243

Total revenues

 

 

76,527

 

 

 

72,386

 

 

 

154,881

 

 

 

138,649

Expenses:

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold – commercial

 

 

4,607

 

 

 

5,605

 

 

 

8,375

 

 

 

9,424

Cost of revenue – collaborations and services

 

 

15,961

 

 

 

14,772

 

 

 

29,709

 

 

 

29,551

Research and development

 

 

13,675

 

 

 

11,816

 

 

 

24,697

 

 

 

21,829

Selling, general and administrative

 

 

31,622

 

 

 

24,112

 

 

 

56,636

 

 

 

46,441

Loss (gain) on foreign currency transaction

 

 

5,363

 

 

 

(529

)

 

 

7,872

 

 

 

(1,928

Total expenses

 

 

71,228

 

 

 

55,776

 

 

 

127,289

 

 

 

105,317

Income from operations

 

 

5,299

 

 

 

16,610

 

 

 

27,592

 

 

 

33,332

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

1,832

 

 

 

3,177

 

 

 

3,788

 

 

 

6,611

Interest expense

 

 

(285

)

 

 

(6,051

)

 

 

(4,930

)

 

 

(8,618

Interest expense on liability for sale of future royalties

 

 

(3,473

)

 

 

(4,383

)

 

 

(7,050

)

 

 

(8,631

Interest expense on financing liability

 

 

(2,433

)

 

 

(2,444

)

 

 

(4,843

)

 

 

(4,891

Loss on settlement of debt

 

 

 

 

 

(7,050

)

 

 

 

 

 

(7,050

Loss on available-for-sale securities

 

 

 

 

 

(1,550

)

 

 

 

 

 

(1,550

Total other expense

 

 

(4,359

)

 

 

(18,301

)

 

 

(13,035

)

 

 

(24,129

Income (loss) before income tax expense

 

 

940

 

 

 

(1,691

)

 

 

14,557

 

 

 

9,203

Income tax expense

 

 

272

 

 

 

323

 

 

 

731

 

 

 

587

Net income (loss)

 

$

668

 

 

$

(2,014

)

 

$

13,826

 

 

$

8,616

Net income (loss) per share – basic

 

$

0.00

 

 

$

(0.01

)

 

$

0.05

 

 

$

0.03

Weighted average shares used to compute net income (loss)
   per share – basic

 

 

304,954

 

 

 

273,056

 

 

 

304,222

 

 

 

271,706

Net income (loss) per share – diluted

 

$

0.00

 

 

$

(0.01

)

 

$

0.04

 

 

$

0.03

Weighted average shares used to compute net income (loss)
   per share – diluted

 

 

311,484

 

 

 

273,056

 

 

 

312,381

 

 

 

279,358

 

 

 


MANNKIND CORPORATION AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

 

 

June 30, 2025

 

 

December 31, 2024

 

 

 

(In thousands except share
and per share data)

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

57,006

 

 

$

46,339

 

Short-term investments

 

 

121,979

 

 

 

150,917

 

Accounts receivable, net

 

 

27,142

 

 

 

11,804

 

Inventory

 

 

28,491

 

 

 

27,886

 

Prepaid expenses and other current assets

 

 

44,409

 

 

 

31,360

 

Total current assets

 

 

279,027

 

 

 

268,306

 

Restricted cash

 

 

741

 

 

 

737

 

Long-term investments

 

 

22,240

 

 

 

5,482

 

Property and equipment, net

 

 

82,965

 

 

 

85,365

 

Goodwill

 

 

1,931

 

 

 

1,931

 

Other intangible assets

 

 

5,169

 

 

 

5,265

 

Other assets

 

 

19,624

 

 

 

26,757

 

Total assets

 

$

411,697

 

 

$

393,843

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

10,257

 

 

$

6,792

 

Accrued expenses and other current liabilities

 

 

30,915

 

 

 

40,293

 

Senior convertible notes – current

 

 

36,166

 

 

 

 

Liability for sale of future royalties – current

 

 

13,344

 

 

 

12,283

 

Financing liability – current

 

 

10,190

 

 

 

10,062

 

Deferred revenue – current

 

 

10,954

 

 

 

12,407

 

Total current liabilities

 

 

111,826

 

 

 

81,837

 

Liability for sale of future royalties – long term

 

 

137,230

 

 

 

137,362

 

Financing liability – long term

 

 

93,476

 

 

 

93,877

 

Deferred revenue – long term

 

 

45,472

 

 

 

51,160

 

Recognized loss on purchase commitments – long term

 

 

66,076

 

 

 

58,204

 

Operating lease liability

 

 

10,656

 

 

 

11,645

 

Milestone liabilities

 

 

2,003

 

 

 

2,523

 

Senior convertible notes

 

 

 

 

 

36,051

 

Total liabilities

 

 

466,739

 

 

 

472,659

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders' deficit:

 

 

 

 

 

 

Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized;
   no shares issued or outstanding as of June 30, 2025 or December 31, 2024

 

 

 

 

 

 

Common stock, $0.01 par value – 800,000,000 shares authorized;
   306,332,133 and 302,959,782 shares issued and outstanding as of
  June 30, 2025 and December 31, 2024, respectively

 

 

3,063

 

 

 

3,029

 

Additional paid-in capital

 

 

3,128,631

 

 

 

3,118,865

 

Accumulated other comprehensive income

 

 

1,257

 

 

 

1,109

 

Accumulated deficit

 

 

(3,187,993

)

 

 

(3,201,819

)

Total stockholders' deficit

 

 

(55,042

)

 

 

(78,816

)

Total liabilities and stockholders' deficit

 

$

411,697

 

 

$

393,843

 

 

 


Non-GAAP Measures

To supplement MannKind's condensed consolidated financial statements presented under GAAP, we are presenting non-GAAP financial measures for net income and net income per share – basic. We are providing these non-GAAP financial measures, which are among the indicators management uses as a basis for evaluating our financial performance, to disclose additional information to facilitate the comparison of past and present operations. 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 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 press release 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 June 30,

 

 

Six Months
Ended June 30,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

 

Net Income

 

 

Basic EPS

 

 

Net Income

 

 

Basic EPS

 

 

Net Income

 

 

Basic EPS

 

 

Net Income

 

 

Basic EPS

 

 

(In thousands except per share data)

 

GAAP reported net income

$

668

 

 

$

 

 

$

(2,014

)

 

$

(0.01

)

 

$

13,826

 

 

$

0.05

 

 

$

8,616

 

 

$

0.03

 

Non-GAAP adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sold portion of royalty revenue (1)

 

(3,123

)

 

 

(0.01

)

 

 

(2,559

)

 

 

(0.01

)

 

 

(6,123

)

 

 

(0.02

)

 

 

(4,824

)

 

 

(0.02

)

Interest expense on liability for sale of future royalties

 

3,473

 

 

0.01

 

 

 

4,383

 

 

 

0.02

 

 

 

7,050

 

 

 

0.02

 

 

 

8,631

 

 

 

0.03

 

Stock compensation

 

7,520

 

 

 

0.03

 

 

 

6,428

 

 

 

0.02

 

 

 

12,905

 

 

 

0.04

 

 

 

10,313

 

 

 

0.04

 

Loss (gain) on foreign currency transaction

 

5,363

 

 

 

0.02

 

 

 

(529

)

 

 

 

 

 

7,872

 

 

 

0.03

 

 

 

(1,928

)

 

 

(0.01

)

Loss on settlement of debt

 

 

 

 

 

 

 

7,050

 

 

 

0.02

 

 

 

 

 

 

 

 

 

7,050

 

 

 

0.03

 

Loss on available-for-sale securities

 

 

 

 

 

 

 

1,550

 

 

 

0.01

 

 

 

 

 

 

 

 

 

1,550

 

 

 

0.01

 

Non-GAAP adjusted net income

$

13,901

 

 

$

0.05

 

 

$

14,309

 

 

$

0.05

 

 

$

35,530

 

 

$

0.12

 

 

$

29,408

 

 

$

0.11

 

Weighted average shares used to compute net income
    per share – basic

 

304,954

 

 

 

 

 

 

273,056

 

 

 

 

 

 

304,222

 

 

 

 

 

 

271,706