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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, 2021

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.)

 

 

30930 Russell Ranch Road, Suite 300

Westlake Village, California

91362

(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 29, 2021, there were 251,256,353 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, 2021

TABLE OF CONTENTS

 

 

Page

PART I: FINANCIAL INFORMATION

2

 

 

Item 1. Financial Statements (Unaudited)

2

Condensed Consolidated Balance Sheets: September 30, 2021 and December 31, 2020

2

Condensed Consolidated Statements of Operations: Three and nine months ended September 30, 2021 and 2020

3

Condensed Consolidated Statements of Comprehensive Loss: Three and nine months ended September 30, 2021 and 2020

4

Condensed Consolidated Statements of Stockholders’ Deficit: Three and nine months ended September 30, 2021 and 2020

5

Condensed Consolidated Statements of Cash Flows: Nine months ended September 30, 2021 and 2020

7

Notes to Condensed Consolidated Financial Statements

8

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

33

Item 3. Quantitative and Qualitative Disclosures About Market Risk

42

Item 4. Controls and Procedures

42

 

 

PART II: OTHER INFORMATION

43

 

 

Item 1. Legal Proceedings

43

Item 1A. Risk Factors

43

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

70

Item 3. Defaults Upon Senior Securities

70

Item 4. Mine Safety Disclosures

70

Item 5. Other Information

70

Item 6. Exhibits

72

 

 

SIGNATURES

74

 

 

 

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, 2021

 

 

December 31, 2020

 

ASSETS

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

51,740

 

 

$

67,005

 

Restricted cash

 

 

 

 

158

 

Short-term investments

 

87,312

 

 

 

 

Accounts receivable, net

 

9,445

 

 

 

4,218

 

Inventory

 

7,482

 

 

 

4,973

 

Prepaid expenses and other current assets

 

3,227

 

 

 

3,122

 

Total current assets

 

159,206

 

 

 

79,476

 

Property and equipment, net

 

30,848

 

 

 

25,867

 

Long-term investments

 

42,059

 

 

 

 

Other assets

 

6,094

 

 

 

3,265

 

Total assets

$

238,207

 

 

$

108,608

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

9,528

 

 

$

5,582

 

Accrued expenses and other current liabilities

 

20,829

 

 

 

19,707

 

PPP loan — current

 

 

 

 

4,061

 

Deferred revenue — current

 

14,016

 

 

 

33,275

 

Recognized loss on purchase commitments — current

 

5,660

 

 

 

11,080

 

Total current liabilities

 

50,033

 

 

 

73,705

 

Senior convertible notes

 

223,580

 

 

 

 

MidCap credit facility

 

38,723

 

 

 

49,335

 

Mann Group promissory notes

 

18,425

 

 

 

63,027

 

Accrued interest — Mann Group promissory notes

 

286

 

 

 

4,150

 

PPP loan — long term

 

 

 

 

812

 

2024 convertible notes

 

 

 

 

5,000

 

Recognized loss on purchase commitments — long term

 

79,653

 

 

 

84,208

 

Operating lease liability

 

798

 

 

 

1,202

 

Deferred revenue  — long term

 

1,552

 

 

 

1,662

 

Milestone rights liability

 

4,838

 

 

 

5,926

 

Deposits from customer

 

5,007

 

 

 

 

Total liabilities

 

422,895

 

 

 

289,027

 

Commitments and contingencies (Note 12)

 

 

 

 

 

 

 

Stockholders' deficit:

 

 

 

 

 

 

 

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

   no shares issued or outstanding as of September 30, 2021 and December 31, 2020

 

 

 

 

 

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

   250,245,831 and 242,117,089 shares issued and outstanding

   at September 30, 2021 and December 31, 2020, respectively

 

2,502

 

 

 

2,421

 

Additional paid-in capital

 

2,914,818

 

 

 

2,866,303

 

Accumulated deficit

 

(3,102,008

)

 

 

(3,049,143

)

Total stockholders' deficit

 

(184,688

)

 

 

(180,419

)

Total liabilities and stockholders' deficit

$

238,207

 

 

$

108,608

 

 

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,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenue — commercial product sales

$

9,753

 

 

$

7,275

 

 

$

27,828

 

 

$

22,260

 

Revenue — collaborations and services

 

12,458

 

 

 

8,077

 

 

 

35,099

 

 

 

24,441

 

Total revenues

 

22,211

 

 

 

15,352

 

 

 

62,927

 

 

 

46,701

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

3,812

 

 

 

3,591

 

 

 

12,538

 

 

 

11,432

 

Cost of revenue — collaborations and services

 

6,075

 

 

 

1,581

 

 

 

14,885

 

 

 

6,926

 

Research and development

 

3,655

 

 

 

1,484

 

 

 

8,426

 

 

 

4,703

 

Selling, general and administrative

 

17,221

 

 

 

13,899

 

 

 

54,690

 

 

 

41,919

 

Asset impairment

 

106

 

 

 

 

 

 

106

 

 

 

1,889

 

(Gain) loss on foreign currency translation

 

(2,068

)

 

 

3,927

 

 

 

(5,003

)

 

 

3,998

 

Loss on purchase commitments

 

 

 

 

 

 

 

339

 

 

 

 

Total expenses

 

28,801

 

 

 

24,482

 

 

 

85,981

 

 

 

70,867

 

Loss from operations

 

(6,590

)

 

 

(9,130

)

 

 

(23,054

)

 

 

(24,166

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

36

 

 

 

18

 

 

 

64

 

 

 

165

 

Interest expense on notes

 

(2,709

)

 

 

(1,057

)

 

 

(10,943

)

 

 

(3,212

)

Interest expense on Mann Group promissory notes

 

(94

)

 

 

(1,318

)

 

 

(1,492

)

 

 

(3,858

)

Gain (loss) on extinguishment of debt, net

 

4,930

 

 

 

 

 

 

(17,200

)

 

 

 

Other income (expense)

 

1

 

 

 

14

 

 

 

(240

)

 

 

24

 

Total other income (expense)

 

2,164

 

 

 

(2,343

)

 

 

(29,811

)

 

 

(6,881

)

Loss before provision for income taxes

 

(4,426

)

 

 

(11,473

)

 

 

(52,865

)

 

 

(31,047

)

Provision for income taxes

 

 

 

 

218

 

 

 

 

 

 

218

 

Net loss

$

(4,426

)

 

$

(11,255

)

 

$

(52,865

)

 

$

(30,829

)

Net loss per share - basic and diluted

$

(0.02

)

 

$

(0.05

)

 

$

(0.21

)

 

$

(0.14

)

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

 

249,910

 

 

 

229,668

 

 

 

248,624

 

 

 

218,559

 

 

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,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net loss

$

(4,426

)

 

$

(11,255

)

 

$

(52,865

)

 

$

(30,829

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cumulative translation loss

 

 

 

 

 

 

 

 

 

 

(19

)

Comprehensive loss

$

(4,426

)

 

$

(11,255

)

 

$

(52,865

)

 

$

(30,848

)

 

See notes to condensed consolidated financial statements.

 

4


 

MANNKIND CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(Unaudited)

(In thousands)

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Total

 

BALANCE, JANUARY 1, 2020

 

 

211,788

 

 

$

2,118

 

 

$

2,799,278

 

 

$

(19

)

 

$

(2,991,903

)

 

$

(190,526

)

Issuance of common stock under Employee

   Stock Purchase Plan

 

 

334

 

 

 

3

 

 

 

315

 

 

 

 

 

 

 

 

 

318

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,128

 

 

 

 

 

 

 

 

 

1,128

 

Issuance of common stock associated

   with debt interest payment

 

 

99

 

 

 

1

 

 

 

143

 

 

 

 

 

 

 

 

 

144

 

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

 

504

 

 

 

5

 

 

 

(322

)

 

 

 

 

 

 

 

 

(317

)

Issuance of common stock in at-the-market

   offering

 

 

413

 

 

 

4

 

 

 

518

 

 

 

 

 

 

 

 

 

522

 

Issuance cost associated with at-the-market

   offering

 

 

 

 

 

 

 

 

(16

)

 

 

 

 

 

 

 

 

(16

)

Write-off of cumulative translation loss

 

 

 

 

 

 

 

 

 

 

 

19

 

 

 

 

 

 

19

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,322

)

 

 

(9,322

)

BALANCE, MARCH 31, 2020

 

 

213,138

 

 

$

2,131

 

 

$

2,801,044

 

 

$

 

 

$

(3,001,225

)

 

$

(198,050

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,185

 

 

 

 

 

 

 

 

 

2,185

 

Issuance of common stock from the

   exercise of warrants

 

 

7,250

 

 

 

73

 

 

 

11,527

 

 

 

 

 

 

 

 

 

11,600

 

Issuance of common stock pursuant to

   conversion of the June 2020 note

 

 

1,235

 

 

 

12

 

 

 

2,618

 

 

 

 

 

 

 

 

 

2,630

 

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

 

297

 

 

 

3

 

 

 

114

 

 

 

 

 

 

 

 

 

117

 

Issuance of common stock in at-the-market

   offering

 

 

7,459

 

 

 

75

 

 

 

12,291

 

 

 

 

 

 

 

 

 

12,366

 

Issuance cost associated with at-the-market

   offering

 

 

 

 

 

 

 

 

(320

)

 

 

 

 

 

 

 

 

(320

)

Issuance of common stock from market

   price stock purchase

 

 

10

 

 

 

 

 

 

14

 

 

 

 

 

 

 

 

 

14

 

Adjustment of common stock in association

   with restricted stock units

 

 

(461

)

 

 

(5

)

 

 

5

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,252

)

 

 

(10,252

)

BALANCE, JUNE 30, 2020

 

 

228,928

 

 

$

2,289

 

 

$

2,829,478

 

 

$

 

 

$

(3,011,477

)

 

$

(179,710

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,294

 

 

 

 

 

 

 

 

 

1,294

 

Issuance of common stock associated

   with debt interest payment

 

 

89

 

 

 

1

 

 

 

143

 

 

 

 

 

 

 

 

 

144

 

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

 

82

 

 

 

1

 

 

 

100

 

 

 

 

 

 

 

 

 

101

 

Issuance of common stock in at the market

   offering

 

 

1,531

 

 

 

15

 

 

 

2,664