Form 8-K

8-K — MANNKIND CORP

Accession: 0001193125-26-208910

Filed: 2026-05-06

Period: 2026-05-06

CIK: 0000899460

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — mnkd-20260506.htm (Primary)

EX-99.1 (mnkd-ex99_1.htm)

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8-K

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 06, 2026

MannKind Corporation

(Exact name of Registrant as Specified in Its Charter)

Delaware

000-50865

13-3607736

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

1 Casper Street

Danbury, Connecticut

06810

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (818) 661-5000

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.01 per share

MNKD

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On May 6, 2026, MannKind Corporation issued a press release, a copy of which is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

Exhibit 99.1

Press release dated May 6, 2026

Exhibit 104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

MannKind Corporation

Date: May 6, 2026

By:

/s/ David Thomson, Ph.D., J.D.

David Thomson, Ph.D., J.D.

Corporate Vice President, General Counsel and Secretary

EX-99.1

Filename: mnkd-ex99_1.htm · Sequence: 2

EX-99.1

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



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



Conference call and webcast today at 4:30 p.m. ET

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 6, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD)

a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today reported financial results for the first quarter of 2026, and provided a business update.

“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 Michael Castagna, Chief Executive Officer of MannKind Corporation. “2026 is the most catalyst-rich year in the Company’s history. The Furoscix ReadyFlow Autoinjector, if approved, represents an opportunity to scale the brand’s growth trajectory. At the same time, we are excited and prepared for the potential Afrezza approval and launch in pediatrics, which would address unmet needs of a new patient population. Combined with the continued momentum of Tyvaso DPI, including its expansion into IPF, a strengthening pipeline, and our expanded collaboration with United Therapeutics to advance ralinepag DPI, MannKind is well positioned to deliver sustained, long-term value for shareholders.”

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 of MannKind common stock

First Quarter 2026 Financial Results

Revenues

Three Months

Ended March 31,

2026

2025

$ Change

% Change

Revenues

(Dollars in thousands)

Afrezza

15,273

14,887

386

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

Total revenues

90,171

78,354

11,817

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 October 7, 2025. Collaborations and services revenue decreased due to fewer units sold to United Therapeutics (UT). The increase in royalties was due to UT’s increase in net revenue from sales of Tyvaso DPI.

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.



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

MannKind will host a conference call and 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 at https://investors.mannkindcorp.com/events-and-presentations. 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) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

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 MannKind's expectations about 2026 being a catalyst-rich year; the potential benefits of and potential pediatric launch of Afrezza, and the expected timing thereof; expectations regarding MannKind’s ongoing and planned clinical trials and nonclinical studies, including the timing for enrollment for the Phase 2 clinical trial of MNKD-201 in IPF and the expected timing for data readouts from the Phase 1b clinical trial of MNKD-201, and preclinical development of MNKD-701 and MNKD-1501; development plans for MNKD-1501 and the potential achievement of milestone payments and royalties; the opportunity and potential benefits of Furoscix; the potential approval of Furoscix ReadyFlow Autoinjector, the timing of such approval and its potential impact on the growth trajectory for Furoscix; and the potential of MannKind to deliver long-term value. 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 March 31, 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 Contacts:

Investor Relations

Kate Miranda

Email: ir@mnkd.com

Media Relations

Christie Iacangelo

Email: media@mnkd.com

MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS

Three Months

Ended March 31,

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

March 31, 2026

December 31, 2025

(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

Goodwill

67,595

Developed technology - on-body infusor

185,708

190,027

IPR&D - ReadyFlow Formulation

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

Term loan

318,722

318,361

Total liabilities

803,598

843,204

Commitments and contingencies

Stockholders' deficit:

Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized;

no shares issued or outstanding as of March 31, 2026 or December 31, 2025

—

Common stock, $0.01 par value – 800,000,000 shares authorized;

308,907,331 and 307,832,587 shares issued and outstanding as of

March 31, 2026 and December 31, 2025, respectively

3,089

3,078

Additional paid-in capital

3,150,295

3,141,741

Accumulated other comprehensive (loss) income

)

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 March 31,

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 March 31, 2026 and 2025 which is remitted to the royalty purchaser and recognized as royalties from collaborations in our condensed consolidated statements of operations. Our revenues from royalties from collaborations during the three months ended March 31, 2026 and 2025 totaled $32.7 million and $30.0 million, respectively, of which $3.3 million and $3.0 million, respectively, was remitted to the royalty purchaser.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

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- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

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Namespace Prefix:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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