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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022

Or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                  to                 .

Commission file number: 000-50865

 

MannKind Corporation

(Exact name of registrant as specified in its charter)

 

 

Delaware

13-3607736

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

1 Casper Street 

Danbury, Connecticut

06810

(Address of principal executive offices)

(Zip Code)

(818) 661-5000

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes      No   

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

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.  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).     Yes      No  

As of October 28, 2022, there were 263,195,593 shares of the registrant’s common stock, $0.01 par value per share, outstanding.

 

 

 

 


 

MANNKIND CORPORATION

Form 10-Q

For the Quarterly Period Ended September 30, 2022

TABLE OF CONTENTS

 

 

Page

PART I: FINANCIAL INFORMATION

2

 

 

Item 1. Financial Statements (Unaudited)

2

Condensed Consolidated Balance Sheets: September 30, 2022 and December 31, 2021

2

Condensed Consolidated Statements of Operations: Three and nine months ended September 30, 2022 and 2021

3

Condensed Consolidated Statements of Comprehensive Loss: Three and nine months ended September 30, 2022 and 2021

4

Condensed Consolidated Statements of Stockholders’ Deficit: Three and nine months ended September 30, 2022 and 2021

5

Condensed Consolidated Statements of Cash Flows: Nine months ended September 30, 2022 and 2021

7

Notes to Condensed Consolidated Financial Statements

8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

36

Item 3. Quantitative and Qualitative Disclosures About Market Risk

43

Item 4. Controls and Procedures

43

 

 

PART II: OTHER INFORMATION

45

 

 

Item 1. Legal Proceedings

45

Item 1A. Risk Factors

45

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

75

Item 3. Defaults Upon Senior Securities

75

Item 4. Mine Safety Disclosures

75

Item 5. Other Information

75

Item 6. Exhibits

76

 

 

SIGNATURES

78

 

 

 

1


 

PART 1: FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except share and per share data)

 

 

September 30, 2022

 

 

December 31, 2021

 

ASSETS

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

54,308

 

 

$

124,184

 

Short-term investments

 

110,738

 

 

 

79,932

 

Accounts receivable, net

 

23,493

 

 

 

4,739

 

Inventory

 

18,273

 

 

 

7,152

 

Prepaid expenses and other current assets

 

11,569

 

 

 

3,482

 

Total current assets

 

218,381

 

 

 

219,489

 

Property and equipment, net

 

41,182

 

 

 

36,612

 

Goodwill

 

3,067

 

 

 

 

Other intangible asset

 

1,169

 

 

 

 

Long-term investments

 

12,728

 

 

 

56,619

 

Other assets

 

17,310

 

 

 

8,441

 

Total assets

$

293,837

 

 

$

321,161

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

9,871

 

 

$

6,956

 

Accrued expenses and other current liabilities

 

30,350

 

 

 

27,419

 

Financing liability — current

 

9,525

 

 

 

6,977

 

Deferred revenue — current

 

1,786

 

 

 

827

 

Recognized loss on purchase commitments — current

 

8,065

 

 

 

6,170

 

Total current liabilities

 

59,597

 

 

 

48,349

 

Senior convertible notes

 

225,034

 

 

 

223,944

 

Midcap credit facility

 

39,155

 

 

 

38,833

 

Mann Group convertible note

 

8,829

 

 

 

18,425

 

Accrued interest — promissory note

 

56

 

 

 

404

 

Financing liability — long term

 

94,484

 

 

 

93,525

 

Recognized loss on purchase commitments — long term

 

62,173

 

 

 

76,659

 

Operating lease liability

 

5,666

 

 

 

1,040

 

Deferred revenue  — long term

 

31,996

 

 

 

19,543

 

Milestone liabilities

 

4,524

 

 

 

4,838

 

Deposits from customer

 

 

 

 

4,950

 

Total liabilities

 

531,514

 

 

 

530,510

 

Commitments and contingencies (Note 15)

 

 

 

 

 

 

 

Stockholders' deficit:

 

 

 

 

 

 

 

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

   no shares issued or outstanding as of September 30, 2022 and December 31, 2021

 

 

 

 

 

Common stock, $0.01 par value - 400,000,000 shares authorized,

   263,156,165 and 251,477,562 shares issued and outstanding

   at September 30, 2022 and December 31, 2021, respectively

 

2,632

 

 

 

2,515

 

Additional paid-in capital

 

2,960,419

 

 

 

2,918,205

 

Accumulated other comprehensive loss

 

(1,206

)

 

 

 

Accumulated deficit

 

(3,199,522

)

 

 

(3,130,069

)

Total stockholders' deficit

 

(237,677

)

 

 

(209,349

)

Total liabilities and stockholders' deficit

$

293,837

 

 

$

321,161

 

 

See notes to condensed consolidated financial statements.

2


MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share data)

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenue — commercial product sales

$

16,259

 

 

$

9,753

 

 

$

38,807

 

 

$

27,828

 

Revenue — collaborations and services

 

10,346

 

 

 

12,458

 

 

 

18,380

 

 

 

35,099

 

Royalties — collaborations

 

6,220

 

 

 

 

 

 

6,524

 

 

 

 

Total revenues

 

32,825

 

 

 

22,211

 

 

 

63,711

 

 

 

62,927

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

5,021

 

 

 

3,812

 

 

 

11,922

 

 

 

12,538

 

Cost of revenue — collaborations and services

 

12,439

 

 

 

6,075

 

 

 

29,451

 

 

 

14,885

 

Research and development

 

4,136

 

 

 

3,655

 

 

 

12,565

 

 

 

8,426

 

Selling, general and administrative

 

22,638

 

 

 

17,221

 

 

 

69,378

 

 

 

54,690

 

Asset impairment

 

 

 

 

106

 

 

 

 

 

 

106

 

Gain on foreign currency translation

 

(1,799

)

 

 

(2,068

)

 

 

(8,285

)

 

 

(5,003

)

Loss on purchase commitments

 

 

 

 

 

 

 

 

 

 

339

 

Total expenses

 

42,435

 

 

 

28,801

 

 

 

115,031

 

 

 

85,981

 

Loss from operations

 

(9,610

)

 

 

(6,590

)

 

 

(51,320

)

 

 

(23,054

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

663

 

 

 

36

 

 

 

1,556

 

 

 

64

 

Interest expense on financing liability

 

(2,466

)

 

 

 

 

 

(7,280

)

 

 

 

Interest expense on notes

 

(2,812

)

 

 

(2,803

)

 

 

(12,202

)

 

 

(12,435

)

Gain (loss) on extinguishment of debt, net

 

 

 

 

4,930

 

 

 

 

 

 

(17,200

)

Other (expense) income

 

(207

)

 

 

1

 

 

 

(207

)

 

 

(240

)

Total other expense

 

(4,822

)

 

 

2,164

 

 

 

(18,133

)

 

 

(29,811

)

Loss before provision for income taxes

 

(14,432

)

 

 

(4,426

)

 

 

(69,453

)

 

 

(52,865

)

Provision for income taxes

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(14,432

)

 

$

(4,426

)

 

$

(69,453

)

 

$

(52,865

)

Net loss per share - basic and diluted

$

(0.06

)

 

$

(0.02

)

 

$

(0.27

)

 

$

(0.21

)

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

 

259,300

 

 

 

249,910

 

 

 

254,974

 

 

 

248,624

 

 

See notes to condensed consolidated financial statements.

 

3


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

(In thousands)

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

$

(14,432

)

 

$

(4,426

)

 

$

(69,453

)

 

$

(52,865

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

(1,206

)

 

 

 

Comprehensive loss

$

(14,432

)

 

$

(4,426

)

 

$

(70,659

)

 

$

(52,865

)

 

 

See notes to condensed consolidated financial statements.

 

4


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(Unaudited)

(In thousands)

 

 

 

Common Stock

 

 

Additional

 

 

Accumulated Other

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Paid-in Capital

 

 

Comprehensive Loss

 

 

Deficit

 

 

Total

 

BALANCE, JANUARY 1, 2021

 

 

242,118

 

 

$

2,421

 

 

$

2,866,303

 

 

$

 

 

$

(3,049,143

)

 

$

(180,419

)

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

 

390

 

 

 

4

 

 

 

393

 

 

 

 

 

 

 

 

 

397

 

Issuance of common stock under Employee

   Stock Purchase Plan

 

 

293

 

 

 

3

 

 

 

387

 

 

 

 

 

 

 

 

 

390

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,935

 

 

 

 

 

 

 

 

 

1,935

 

Issuance of common stock pursuant to

   conversion of the Mann Group

   convertible note

 

 

3,830

 

 

 

38

 

 

 

9,535

 

 

 

 

 

 

 

 

 

9,573

 

Issuance of common stock pursuant to

   conversion of the Mann Group

   convertible note interest

 

 

170

 

 

 

2

 

 

 

425

 

 

 

 

 

 

 

 

 

427

 

Issuance of common stock pursuant to

   conversion of the 2024 convertible notes

 

 

1,667

 

 

 

17

 

 

 

4,983

 

 

 

 

 

 

 

 

 

5,000

 

Issuance of common stock pursuant to

   payoff of the 2024 convertible note

   interest

 

 

27

 

 

 

 

 

 

143

 

 

 

 

 

 

 

 

 

143

 

Issuance of at-the-market placement

 

 

578

 

 

 

6

 

 

 

1,880

 

 

 

 

 

 

 

 

 

1,886

 

Issuance costs associated with at-the-

   market placement

 

 

 

 

 

 

 

 

(38

)

 

 

 

 

 

 

 

 

(38

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,916

)

 

 

(12,916

)

BALANCE, MARCH 31, 2021

 

 

249,073

 

 

$

2,491

 

 

$

2,885,946

 

 

$

 

 

$

(3,062,059

)

 

$

(173,622

)

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

 

520

 

 

 

5

 

 

 

(550

)

 

 

 

 

 

 

 

 

(545

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,926

 

 

 

 

 

 

 

 

 

3,926

 

Premium on Mann Group convertible note

 

 

 

 

 

 

 

 

22,107

 

 

 

 

 

 

 

 

 

22,107

 

Issuance of common stock from market

   price stock purchase

 

 

25

 

 

 

 

 

 

106

 

 

 

 

 

 

 

 

 

106

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(35,523

)

 

 

(35,523

)

BALANCE, JUNE 30, 2021

 

 

249,618

 

 

$

2,496

 

 

$

2,911,535

 

 

$

 

 

$

(3,097,582

)

 

$

(183,551

)

Issuance of common stock associated

   with debt interest payment

 

 

394

 

 

 

4

 

 

 

(594

)

 

 

 

 

 

 

 

 

(590

)

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

 

234

 

 

 

2

 

 

 

698

 

 

 

 

 

 

 

 

 

700

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,179