8-K/A
0000899460true00008994602023-05-092023-05-09

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K/A

 

(AMENDMENT NO. 1)

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 09, 2023

 

 

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.

 

 


Explanatory Note

This Amendment No. 1 on Form 8-K/A is being filed by MannKind Corporation, a Delaware corporation (the “Company”) solely to correct the date of the comparative period on the condensed consolidated balance sheets included in the Exhibit 99.1 in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 9, 2023 (the “Original Report”) and to re-file Exhibit 99.1 thereto. The Original Report incorrectly stated March 31, 2022 as the date for the comparative period on the condensed consolidated balance sheets. The correct date is December 31, 2022.

In accordance with Rule 12b-15 of the Securities Exchange Act of 1934, as amended, the complete text of Item 9.01 (as amended) follows.
 


Item 2.02. Results of Operations and Financial Condition.

On May 9, 2023, MannKind Corporation issued a corrected 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 9, 2023

 

 

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 9, 2023

By:

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

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

Corporate Vice President, General Counsel and Secretary

 

 


EX-99

 

https://cdn.kscope.io/955050a57295c38f205d8325df40e2ed-img208524907_0.jpg 

EXHIBIT 99.1

 

MANNKIND CORPORATION REPORTS
2023 FIRST QUARTER FINANCIAL RESULTS


Conference Call to Begin Today at 5:00 p.m. (ET)

1Q 2023 Total Revenues of $41 million; +239% vs. 1Q 2022
1Q 2023 Revenues associated with Tyvaso DPI of $23 million
1Q 2023 Loss from operations decreased 72% vs. 1Q 2022 to $6 million
$167 million of Cash, Cash Equivalents and Investments at March 31, 2023

 

DANBURY, Conn. and WESTLAKE VILLAGE, Calif. May 9, 2023 (Globe Newswire) — MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended March 31, 2023.

“Demand for Tyvaso DPI® has been very strong, which resulted in $23 million in revenues in the first quarter of 2023,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “I'm excited about our inhaled platform and orphan lung pipeline as we get ready to launch our Phase 2/3 inhaled clofazimine trial for patients in the second half of 2023.”

Revenue Highlights

 

 

Three Months
Ended March 31,

 

 

 

2023

 

 

2022

 

 

$ Change

 

 

% Change

 

 

 

(Dollars in thousands)

 

Net revenue – Afrezza

 

$

12,423

 

 

$

9,826

 

 

$

2,597

 

 

 

26

%

Net revenue – V-Go

 

 

5,139

 

 

 

 

 

$

5,139

 

 

*

 

Revenue – collaborations and services

 

 

11,386

 

 

 

2,166

 

 

$

9,220

 

 

 

426

%

Royalties – collaborations

 

 

11,678

 

 

 

 

 

$

11,678

 

 

*

 

Total revenues

 

$

40,626

 

 

$

11,992

 

 

$

28,634

 

 

 

239

%

______________________

* Not meaningful

Afrezza® net revenue for the first quarter of 2023 increased compared to the same period in 2022 as a result of higher product demand, higher price (including a more favorable gross-to-net adjustment) and a more favorable cartridge mix. V-Go® was acquired in the second quarter of 2022. The increase in collaborations and services revenue reflected that the commercial manufacturing of Tyvaso DPI had not yet commenced in the prior period. Royalties related to Tyvaso DPI, launched in the second quarter of 2022 by United Therapeutics (“UT”), continued to grow based on strong patient demand.

Commercial product gross margin in the first quarter of 2023 was 69% compared to 77% for the same period in 2022 primarily related to the addition of V-Go in the second quarter of 2022 which had a lower gross margin than Afrezza.

Cost of revenue – collaborations and services for the first quarter of 2023 was $10.7 million compared to $8.7 million for the same period in 2022, an increase of $2.0 million, due to an increase in manufacturing activities for Tyvaso DPI.


Research and development expenses for the first quarter of 2023 were $5.6 million compared to $3.5 million for the same period in 2022. The $2.1 million increase was primarily attributed to costs incurred to develop our product pipeline, including MNKD-101 (inhaled clofazimine) and the Afrezza pediatrics clinical study (INHALE-1).
 

Selling expenses for the first quarter of 2023 were $13.3 million compared to $12.7 million for the same period in 2022. The $0.6 million increase was primarily due to V-Go promotional efforts and increased headcount after the acquisition in the second quarter of 2022 as well as an increase in Afrezza promotional activities, partially offset by the termination of an Afrezza pilot promotional effort targeting primary care physicians which ended in the third quarter of 2022.

 

General and administrative expenses for the first quarter of 2023 were $10.5 million compared to $7.9 million for the same period in 2022. The $2.6 million increase was primarily attributable to higher stock-based compensation, increased headcount, and higher professional fees.

Interest expense on financing liability was $2.4 million for the first quarter of 2023 and remained consistent with the same period in 2022.

Interest expense on notes was $2.8 million in the first quarter of 2023 and remained consistent with the same period in 2022 due to fixed interest rates and no changes in debt balances.

Cash, cash equivalents and investments as of March 31, 2023 were $166.6 million.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind's website for 14 days.

About MannKind

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients 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, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. 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.

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, Twitter 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 pipeline advancement, including the planned launch of MannKind's inhaled clofazimine trial for patients in the second half of 2023. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “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 these risks and uncertainties, which include, without limitation, risks associated with manufacturing and supply, risks associated with product commercialization, risks associated with developing product candidates, risks associated with MannKind’s ability to manage its existing cash resources or raise additional cash resources, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 23, 2023, and under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, 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, MANNKIND, and V-GO are registered trademarks of MannKind Corporation.

# # #

MannKind Contact:

Rose Alinaya, Investor Relations

(818) 661-5000

IR@mannkindcorp.com

 

 


MANNKIND CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

Three Months
Ended March 31,

 

 

 

2023

 

 

2022

 

 

 

(In thousands except per share data)

 

Revenues:

 

 

 

 

 

 

Net revenue – commercial product sales

 

$

17,562

 

 

$

9,826

 

Revenue – collaborations and services

 

 

11,386

 

 

 

2,166

 

Royalties – collaborations

 

 

11,678

 

 

 

 

Total revenues

 

 

40,626

 

 

 

11,992

 

Expenses:

 

 

 

 

 

 

Cost of goods sold

 

 

5,530

 

 

 

2,284

 

Cost of revenue – collaborations and services

 

 

10,683

 

 

 

8,714

 

Research and development

 

 

5,605

 

 

 

3,536

 

Selling

 

 

13,310

 

 

 

12,728

 

General and administrative

 

 

10,542

 

 

 

7,969

 

Loss (gain) on foreign currency transaction

 

 

954

 

 

 

(1,983

)

Total expenses

 

 

46,624

 

 

 

33,248

 

Loss from operations

 

 

(5,998

)

 

 

(21,256

)

Other (expense) income:

 

 

 

 

 

 

Interest income, net

 

 

1,302

 

 

 

377

 

Interest expense on financing liability

 

 

(2,424

)

 

 

(2,371

)

Interest expense on notes

 

 

(2,786

)

 

 

(2,748

)

Other income

 

 

111

 

 

 

 

Total other expense

 

 

(3,797

)

 

 

(4,742

)

Loss before income tax expense

 

 

(9,795

)

 

 

(25,998

)

Benefit from income taxes

 

 

 

 

 

 

Net loss

 

$

(9,795

)

 

$

(25,998

)

Net loss per share – basic and diluted

 

$

(0.04

)

 

$

(0.10

)

Shares used to compute net loss per share
   – basic and diluted

 

 

263,969

 

 

 

251,887

 

 

 


MANNKIND CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

March 31,

 

 

December 31,

 

 

 

2023

 

 

2022

 

 

 

(In thousands except share and per share data)

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

85,869

 

 

$

69,767

 

Short-term investments

 

 

80,273

 

 

 

101,079

 

Accounts receivable, net

 

 

19,714

 

 

 

16,801

 

Inventory

 

 

21,998

 

 

 

21,772

 

Prepaid expenses and other current assets

 

 

15,445

 

 

 

25,477

 

Total current assets

 

 

223,299

 

 

 

234,896

 

Property and equipment, net

 

 

54,837

 

 

 

45,126

 

Goodwill

 

 

1,998

 

 

 

2,428

 

Other intangible asset

 

 

1,133

 

 

 

1,153

 

Long-term investments

 

 

492

 

 

 

1,961

 

Other assets

 

 

16,378

 

 

 

9,718

 

Total assets

 

$

298,137

 

 

$

295,282

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

13,889

 

 

$

11,052

 

Accrued expenses and other current liabilities

 

 

32,995

 

 

 

35,553

 

Financing liability – current

 

 

9,626

 

 

 

9,565

 

Midcap credit facility – current

 

 

11,667

 

 

 

 

Deferred revenue – current

 

 

2,316

 

 

 

1,733

 

Recognized loss on purchase commitments – current

 

 

11,360

 

 

 

9,393

 

Total current liabilities

 

 

81,853

 

 

 

67,296

 

Mann Group convertible note

 

 

8,829

 

 

 

8,829

 

Accrued interest – Mann Group convertible note

 

 

54

 

 

 

55

 

Financing liability – long term

 

 

94,441

 

 

 

94,512

 

Midcap credit facility

 

 

27,704

 

 

 

39,264

 

Senior convertible notes

 

 

225,761

 

 

 

225,397

 

Recognized loss on purchase commitments – long term

 

 

59,829

 

 

 

62,916

 

Operating lease liability

 

 

4,879

 

 

 

5,343

 

Deferred revenue – long term

 

 

45,659

 

 

 

37,684

 

Milestone liabilities

 

 

4,524

 

 

 

4,524

 

Deposits from customer

 

 

 

 

 

 

Total liabilities

 

 

553,533

 

 

 

545,820

 

Stockholders' deficit:

 

 

 

 

 

 

Undesignated preferred stock, $0.01 par value – 10,000,000 shares
   authorized; no shares issued or outstanding as of March 31, 2023
   and December 31, 2022

 

 

 

 

 

 

Common stock, $0.01 par value – 400,000,000 shares authorized,
   264,278,760 and 263,793,305 shares issued and outstanding as of
   March 31, 2023 and December 31, 2022, respectively

 

 

2,643

 

 

 

2,638

 

Additional paid-in capital

 

 

2,969,225

 

 

 

2,964,293

 

Accumulated deficit

 

 

(3,227,264

)

 

 

(3,217,469

)

Total stockholders' deficit

 

 

(255,396

)

 

 

(250,538

)

Total liabilities and stockholders' deficit

 

$

298,137

 

 

$

295,282