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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 June 30, 2024

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 July 26, 2024, there were 274,995,037 shares of the registrant’s common stock, $0.01 par value per share, outstanding.

 

 


 

MANNKIND CORPORATION

Form 10-Q

For the Quarterly Period Ended June 30, 2024

TABLE OF CONTENTS

 

Page

PART I: FINANCIAL INFORMATION

2

 

 

Item 1. Financial Statements (Unaudited)

2

Condensed Consolidated Statements of Operations: Three and six months ended June 30, 2024 and 2023

2

Condensed Consolidated Statements of Comprehensive Income (Loss): Three and six months ended June 30, 2024 and 2023

3

Condensed Consolidated Balance Sheets: June 30, 2024 and December 31, 2023

4

Condensed Consolidated Statements of Stockholders’ Deficit: Three and six months ended June 30, 2024 and 2023

5

Condensed Consolidated Statements of Cash Flows: Six months ended June 30, 2024 and 2023

6

Notes to Condensed Consolidated Financial Statements

7

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

35

Item 3. Quantitative and Qualitative Disclosures About Market Risk

43

Item 4. Controls and Procedures

43

 

 

PART II: OTHER INFORMATION

44

 

 

Item 1. Legal Proceedings

44

Item 1A. Risk Factors

44

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

73

Item 3. Defaults Upon Senior Securities

73

Item 4. Mine Safety Disclosures

73

Item 5. Other Information

73

Item 6. Exhibits

74

 

 

SIGNATURES

75

 

 

 

1


 

PART 1: FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

Three Months
Ended June 30,

 

 

Six Months
Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(In thousands except per share data)

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Net revenue – commercial product sales

 

$

20,780

 

 

$

18,345

 

 

$

39,544

 

 

$

35,907

 

Revenue – collaborations and services

 

 

26,014

 

 

 

11,211

 

 

 

50,862

 

 

 

22,597

 

Royalties – collaboration

 

 

25,592

 

 

 

19,055

 

 

 

48,243

 

 

 

30,733

 

Total revenues

 

 

72,386

 

 

 

48,611

 

 

 

138,649

 

 

 

89,237

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

5,605

 

 

 

5,224

 

 

 

9,424

 

 

 

10,754

 

Cost of revenue – collaborations and services

 

 

14,772

 

 

 

9,013

 

 

 

29,551

 

 

 

19,696

 

Research and development

 

 

11,816

 

 

 

6,453

 

 

 

21,829

 

 

 

12,058

 

Selling

 

 

11,495

 

 

 

14,002

 

 

 

23,096

 

 

 

27,312

 

General and administrative

 

 

12,617

 

 

 

11,947

 

 

 

23,345

 

 

 

22,489

 

(Gain) loss on foreign currency transaction

 

 

(529

)

 

 

251

 

 

 

(1,928

)

 

 

1,205

 

Total expenses

 

 

55,776

 

 

 

46,890

 

 

 

105,317

 

 

 

93,514

 

Income (loss) from operations

 

 

16,610

 

 

 

1,721

 

 

 

33,332

 

 

 

(4,277

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

3,177

 

 

 

1,547

 

 

 

6,611

 

 

 

2,849

 

Interest expense on financing liability

 

 

(2,444

)

 

 

(2,449

)

 

 

(4,891

)

 

 

(4,873

)

Interest expense

 

 

(6,051

)

 

 

(6,873

)

 

 

(8,618

)

 

 

(9,659

)

Interest expense on liability for sale of future royalties

 

 

(4,383

)

 

 

 

 

 

(8,631

)

 

 

 

(Loss) gain on available-for-sale securities

 

 

(1,550

)

 

 

932

 

 

 

(1,550

)

 

 

932

 

Loss on extinguishment of debt

 

 

(7,050

)

 

 

 

 

 

(7,050

)

 

 

 

Other expense

 

 

 

 

 

(143

)

 

 

 

 

 

(32

)

Total other expense

 

 

(18,301

)

 

 

(6,986

)

 

 

(24,129

)

 

 

(10,783

)

Income (loss) before income tax expense

 

 

(1,691

)

 

 

(5,265

)

 

 

9,203

 

 

 

(15,060

)

Income tax expense

 

 

323

 

 

 

 

 

 

587

 

 

 

 

Net income (loss)

 

$

(2,014

)

 

$

(5,265

)

 

$

8,616

 

 

$

(15,060

)

Net income (loss) per share – basic

 

$

(0.01

)

 

$

(0.02

)

 

$

0.03

 

 

$

(0.06

)

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

 

 

273,056

 

 

 

265,626

 

 

 

271,706

 

 

 

264,802

 

Net income (loss) per share – diluted

 

$

(0.01

)

 

$

(0.02

)

 

$

0.03

 

 

$

(0.06

)

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

 

 

273,056

 

 

 

265,626

 

 

 

279,358

 

 

 

264,802

 

 

See notes to condensed consolidated financial statements.

2


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Unaudited)

 

 

Three Months
Ended June 30,

 

 

Six Months
Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(In thousands)

 

Net income (loss)

 

$

(2,014

)

 

$

(5,265

)

 

$

8,616

 

 

$

(15,060

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

443

 

 

 

 

 

 

443

 

Comprehensive income (loss)

 

$

(2,014

)

 

$

(4,822

)

 

$

8,616

 

 

$

(14,617

)

 

See notes to condensed consolidated financial statements.

3


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

 

 

 

 

 

 

June 30, 2024

 

 

December 31, 2023

 

 

 

(In thousands except share
and per share data)

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

96,643

 

 

$

238,480

 

Short-term investments

 

 

151,118

 

 

 

56,619

 

Accounts receivable, net

 

 

23,346

 

 

 

14,901

 

Inventory

 

 

24,753

 

 

 

28,545

 

Prepaid expenses and other current assets

 

 

30,080

 

 

 

34,848

 

Total current assets

 

 

325,940

 

 

 

373,393

 

Restricted cash

 

 

732

 

 

 

 

Long-term investments

 

 

13,398

 

 

 

7,155

 

Property and equipment, net

 

 

85,144

 

 

 

84,220

 

Goodwill

 

 

1,931

 

 

 

1,931

 

Other intangible asset

 

 

1,033

 

 

 

1,073

 

Other assets

 

 

15,658

 

 

 

7,426

 

Total assets

 

$

443,836

 

 

$

475,198

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

9,556

 

 

$

9,580

 

Accrued expenses and other current liabilities

 

 

40,952

 

 

 

42,036

 

Liability for sale of future royalties – current

 

 

12,149

 

 

 

9,756

 

Financing liability – current

 

 

9,935

 

 

 

9,809

 

Deferred revenue – current

 

 

7,420

 

 

 

9,085

 

Recognized loss on purchase commitments – current

 

 

 

 

 

3,859

 

Midcap credit facility – current

 

 

 

 

 

20,000

 

Total current liabilities

 

 

80,012

 

 

 

104,125

 

Senior convertible notes

 

 

227,577

 

 

 

226,851

 

Liability for sale of future royalties – long term

 

 

135,365

 

 

 

136,054

 

Financing liability – long term

 

 

94,094

 

 

 

94,319

 

Deferred revenue – long term

 

 

66,116

 

 

 

69,794

 

Recognized loss on purchase commitments – long term

 

 

60,183

 

 

 

60,942

 

Operating lease liability

 

 

3,272

 

 

 

3,925

 

Financing lease liability

 

 

184

 

 

 

 

Milestone liabilities

 

 

2,813

 

 

 

3,452

 

Mann Group convertible note

 

 

 

 

 

8,829

 

Accrued interest – Mann Group convertible note

 

 

 

 

 

56

 

Midcap credit facility – long term

 

 

 

 

 

13,019

 

Total liabilities

 

 

669,616

 

 

 

721,366

 

Commitments and contingencies (Note 14)

 

 

 

 

 

 

Stockholders' deficit:

 

 

 

 

 

 

Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized;
   
no shares issued or outstanding as of June 30, 2024 or December 31, 2023

 

 

 

 

 

 

Common stock, $0.01 par value – 800,000,000 shares authorized;
   
274,467,247 and 270,034,495 shares issued and outstanding as of
   June 30, 2024 and December 31, 2023, respectively

 

 

2,740

 

 

 

2,700

 

Additional paid-in capital

 

 

2,992,271

 

 

 

2,980,539

 

Accumulated deficit

 

 

(3,220,791

)

 

 

(3,229,407

)

Total stockholders' deficit

 

 

(225,780

)

 

 

(246,168

)

Total liabilities and stockholders' deficit

 

$

443,836

 

 

$

475,198

 

 

See notes to condensed consolidated financial statements.

4


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(Unaudited)

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in Capital

 

 

Accumulated Other Comprehensive Income

 

 

Accumulated Deficit

 

 

Total

 

 

 

(In thousands)

 

BALANCE, JANUARY 1, 2023

 

 

263,793

 

 

$

2,638

 

 

$

2,964,293

 

 

$

 

 

$

(3,217,469

)

 

$

(250,538

)

Issuance of common stock associated
   with at-the-market offering

 

 

269

 

 

 

3

 

 

 

1,196

 

 

 

 

 

 

 

 

 

1,199

 

Issuance costs associated with at-the-market
   offering

 

 

 

 

 

 

 

 

(24

)

 

 

 

 

 

 

 

 

(24

)

Net issuance of common stock associated
   with stock options and restricted stock units

 

206

 

 

 

2

 

 

 

50

 

 

 

 

 

 

 

 

 

52

 

Issuance of common stock pursuant to
   conversion of the Mann Group
   convertible note interest

 

 

11

 

 

 

 

 

 

55

 

 

 

 

 

 

 

 

 

55

 

Stock-based compensation expense

 

 

 

 

 

 

 

3,655

 

 

 

 

 

 

 

 

 

3,655

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,795

)

 

 

(9,795

)

BALANCE, MARCH 31, 2023

 

 

264,279

 

 

$

2,643

 

 

$

2,969,225

 

 

$

 

 

$

(3,227,264

)

 

$

(255,396

)

Issuance of common stock associated
   with at-the-market offering

 

 

362

 

 

 

4

 

 

 

1,579

 

 

 

 

 

 

 

 

 

1,583

 

Issuance costs associated with at-the-market
   offering

 

 

 

 

 

 

 

 

(17

)

 

 

 

 

 

 

 

 

(17

)

Issuance of common stock pursuant to
   conversion of the Mann Group
   convertible note interest

 

 

13

 

 

 

 

 

 

54

 

 

 

 

 

 

 

 

 

54

 

Net issuance of common stock associated
   with stock options and restricted stock
   units

 

 

3,279

 

 

 

32

 

 

 

(8,576

)

 

 

 

 

 

 

 

 

(8,544

)

Issuance of common stock under
   employee stock purchase plan

 

 

266

 

 

 

3

 

 

 

920

 

 

 

 

 

 

 

 

 

923

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

5,580

 

 

 

 

 

 

 

 

 

5,580

 

Issuance of common stock from market
   price stock purchase plan

 

 

36

 

 

 

 

 

 

152

 

 

 

 

 

 

 

 

 

152

 

Cumulative gain on available-for-sale
   securities

 

 

 

 

 

 

 

 

 

 

 

443

 

 

 

 

 

 

443

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,265

)

 

 

(5,265

)

BALANCE, JUNE 30, 2023

 

 

268,235

 

 

$

2,682

 

 

$

2,968,917

 

 

$

443

 

 

$

(3,232,529

)

 

$

(260,487

)

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in Capital

 

 

Accumulated Other Comprehensive Income

 

 

Accumulated Deficit

 

 

Total

 

 

 

(In thousands)

 

BALANCE, JANUARY 1, 2024

 

 

270,034

 

 

$

2,700

 

 

$

2,980,539

 

 

$

 

 

$

(3,229,407

)

 

$

(246,168

)

Issuance of common stock from market
     price stock purchase plan

 

 

416

 

 

 

 

 

 

1,361

 

 

 

 

 

 

 

 

 

1,361

 

Net issuance of common stock associated
   with stock options and restricted stock units

 

337

 

 

 

3

 

 

 

263

 

 

 

 

 

 

 

 

 

266

 

Issuance of common stock pursuant to
   conversion of the Mann Group
   convertible note interest

 

 

15

 

 

 

 

 

 

56

 

 

 

 

 

 

 

 

 

56

 

Stock-based compensation expense

 

 

 

 

 

 

 

3,885

 

 

 

 

 

 

 

 

 

3,885

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10,630

 

 

 

10,630

 

BALANCE, MARCH 31, 2024

 

 

270,802

 

 

$

2,703

 

 

$

2,986,104

 

 

$

 

 

$

(3,218,777

)

 

$

(229,970

)

Net issuance of common stock associated
   with stock options and restricted stock units

 

 

1,855

 

 

 

19

 

 

 

(4,952

)

 

 

 

 

 

 

 

 

(4,933

)

Issuance of common stock pursuant to
   conversion of the Mann Group
   convertible note principal and interest

 

 

1,500

 

 

 

15

 

 

 

3,735

 

 

 

 

 

 

 

 

 

3,750

 

Issuance of common stock under
   employee stock purchase plan

 

 

310

 

 

 

3

 

 

 

956

 

 

 

 

 

 

 

 

 

959

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

6,428

 

 

 

 

 

 

 

 

 

6,428

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,014

)

 

 

(2,014

)

BALANCE, JUNE 30, 2024

 

 

274,467

 

 

$

2,740

 

 

$

2,992,271

 

 

$

 

 

$

(3,220,791

)

 

$

(225,780

)

 

See notes to condensed consolidated financial statements.

5


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

 

(In thousands)

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net income (loss)

 

$

8,616

 

 

$

(15,060

)

Adjustments to reconcile net income (loss) to net cash provided by
   operating activities:

 

 

 

 

 

 

Stock-based compensation

 

 

10,313

 

 

 

9,235

 

Interest on liability for sale of future royalties

 

 

8,631

 

 

 

 

Loss on extinguishment of debt

 

 

7,050

 

 

 

 

Depreciation and amortization

 

 

3,092

 

 

 

2,276

 

Write-off of inventory

 

 

1,618

 

 

 

3,359

 

Loss on available-for-sale securities

 

 

1,550

 

 

 

(932

)

Loss on estimated returns of acquired product

 

 

1,444

 

 

 

 

Amortization of debt discount and issuance costs

 

 

916

 

 

 

941

 

Amortization of right-of-use assets

 

 

647

 

 

 

657

 

Interest on Mann Group convertible note

 

 

56

 

 

 

109

 

Other, net

 

 

49

 

 

 

(152

)

Sold portion of royalty revenue

 

 

(4,824

)

 

 

 

Net accretion of investments

 

 

(2,109

)

 

 

(77

)

(Gain) loss on foreign currency transaction

 

 

(1,928

)

 

 

1,205

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable, net

 

 

(8,890

)

 

 

(10,988

)

Inventory

 

 

2,174

 

 

 

(6,877

)

Prepaid expenses and other current assets

 

 

(5,294

)

 

 

(5,231

)

Other assets

 

 

(2,209

)

 

 

(20

)

Accounts payable

 

 

(24

)

 

 

6,075

 

Accrued expenses and other current liabilities

 

 

(1,763

)

 

 

351

 

Deferred revenue

 

 

(5,343

)

 

 

24,320

 

Recognized loss on purchase commitments

 

 

(2,690

)

 

 

(4,286

)

Operating lease liabilities

 

 

(546

)

 

 

(1,153

)

Net cash provided by operating activities

 

 

10,536

 

 

 

3,752

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

Purchase of held-to-maturity debt securities

 

 

(187,447

)

 

 

(26,447

)

Proceeds from held-to-maturity debt securities

 

 

88,814

 

 

 

69,083

 

Purchase of property and equipment

 

 

(5,380

)

 

 

(25,180

)

Proceeds from insurance claim

 

 

396

 

 

 

 

Net cash (used in) provided by investing activities

 

 

(103,617

)

 

 

17,456

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

Principal and early extinguishment payments on MidCap credit facility

 

 

(36,617

)

 

 

 

Principal and early extinguishment payments on Mann Group convertible note

 

 

(8,854

)

 

 

 

Payments for taxes related to net issuance of common stock associated with
   restricted stock units and stock options

 

 

(4,667

)

 

 

(8,492

)

Proceeds from market price stock purchase plan and employee stock purchase plan

 

 

2,320

 

 

 

1,075

 

Principal payments on financing liability

 

 

(203

)

 

 

(115

)

Principal payments on financing lease liability

 

 

(3

)

 

 

 

Proceeds from at-the-market-offering

 

 

 

 

 

2,782

 

Issuance costs associated with at-the-market offering

 

 

 

 

 

(41

)

Net cash used in financing activities

 

 

(48,024

)

 

 

(4,791

)

NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

 

 

(141,105

)

 

 

16,417

 

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD

 

 

238,480

 

 

 

69,767

 

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD

 

$

97,375

 

 

$

86,184

 

 

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

 

(In thousands)

 

SUPPLEMENTAL CASH FLOWS DISCLOSURES:

 

 

 

 

 

 

   Interest paid in cash

 

$