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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, 2020

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)

 

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 26, 2020, there were 232,600,608 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, 2020

TABLE OF CONTENTS

 

 

Page

PART I: FINANCIAL INFORMATION

2

 

 

Item 1. Financial Statements (Unaudited)

2

Condensed Consolidated Balance Sheets: September 30, 2020 and December 31, 2019

2

Condensed Consolidated Statements of Operations: Three and nine months ended September 30, 2020 and 2019

3

Condensed Consolidated Statements of Comprehensive Loss: Three and nine months ended September 30, 2020 and 2019

4

Condensed Consolidated Statements of Stockholders’ Deficit: Three and nine months ended September 30, 2020 and 2019

5

Condensed Consolidated Statements of Cash Flows: Nine months ended September 30, 2020 and 2019

7

Notes to Condensed Consolidated Financial Statements

8

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

32

Item 3. Quantitative and Qualitative Disclosures About Market Risk

40

Item 4. Controls and Procedures

40

 

 

PART II: OTHER INFORMATION

41

 

 

Item 1. Legal Proceedings

41

Item 1A. Risk Factors

41

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

68

Item 3. Defaults Upon Senior Securities

68

Item 4. Mine Safety Disclosures

68

Item 5. Other Information

68

Item 6. Exhibits

69

 

 

SIGNATURES

71

 

1


 

PART 1: FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MANNKIND CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except per share data)

 

 

 

September 30, 2020

 

 

December 31, 2019

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

52,398

 

 

$

29,906

 

Restricted cash

 

 

316

 

 

 

316

 

Short-term investments

 

 

 

 

 

19,978

 

Accounts receivable, net

 

 

4,135

 

 

 

3,513

 

Inventory

 

 

4,881

 

 

 

4,155

 

Prepaid expenses and other current assets

 

 

4,616

 

 

 

2,889

 

Total current assets

 

 

66,346

 

 

 

60,757

 

Property and equipment, net

 

 

25,736

 

 

 

26,778

 

Other assets

 

 

3,599

 

 

 

6,190

 

Total assets

 

$

95,681

 

 

$

93,725

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,797

 

 

$

4,789

 

Accrued expenses and other current liabilities

 

 

15,814

 

 

 

15,904

 

Short-term notes payable

 

 

45,379

 

 

 

5,028

 

Deferred revenue — current

 

 

28,867

 

 

 

32,503

 

Recognized loss on purchase commitments — current

 

 

10,267

 

 

 

7,394

 

Total current liabilities

 

 

106,124

 

 

 

65,618

 

Promissory notes

 

 

70,025

 

 

 

70,020

 

Accrued interest — promissory notes

 

 

5,854

 

 

 

2,002

 

Long-term Midcap credit facility

 

 

 

 

 

38,851

 

Senior convertible notes

 

 

5,000

 

 

 

5,000

 

Paycheck Protection Program loan — long term

 

 

1,421

 

 

 

 

Recognized loss on purchase commitments — long term

 

 

84,529

 

 

 

84,639

 

Operating lease liability

 

 

1,523

 

 

 

2,514

 

Deferred revenue  — long term

 

 

1,699

 

 

 

8,344

 

Milestone rights liability

 

 

5,926

 

 

 

7,263

 

Total liabilities

 

 

282,101

 

 

 

284,251

 

Commitments and contingencies (Note 11)

 

 

 

 

 

 

 

 

Stockholders' deficit:

 

 

 

 

 

 

 

 

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

   no shares issued or outstanding as of September 30, 2020 and December 31, 2019

 

 

 

 

 

 

Common stock, $0.01 par value - 400,000,000 and 280,000,000 shares

   authorized, 230,922,513 and 211,787,573 shares issued and outstanding

   at September 30, 2020 and December 31, 2019, respectively

 

 

2,309

 

 

 

2,118

 

Additional paid-in capital

 

 

2,834,003

 

 

 

2,799,278

 

Accumulated other comprehensive loss

 

 

 

 

 

(19

)

Accumulated deficit

 

 

(3,022,732

)

 

 

(2,991,903

)

Total stockholders' deficit

 

 

(186,420

)

 

 

(190,526

)

Total liabilities and stockholders' deficit

 

$

95,681

 

 

$

93,725

 

 

See notes to condensed consolidated financial statements.

2


 

MANNKIND CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share data)

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenue — commercial product sales

$

7,275

 

 

$

6,402

 

 

$

22,260

 

 

$

17,543

 

Revenue — collaborations and services

 

8,077

 

 

 

8,193

 

 

 

24,441

 

 

 

29,502

 

Total revenues

 

15,352

 

 

 

14,595

 

 

 

46,701

 

 

 

47,045

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

3,591

 

 

 

7,099

 

 

 

11,432

 

 

 

15,446

 

Cost of revenue — collaborations and services

 

1,581

 

 

 

1,836

 

 

 

6,926

 

 

 

5,512

 

Research and development

 

1,484

 

 

 

1,580

 

 

 

4,703

 

 

 

4,879

 

Selling, general and administrative

 

13,899

 

 

 

16,666

 

 

 

41,919

 

 

 

58,948

 

Asset impairment

 

 

 

 

 

 

 

1,889

 

 

 

 

Loss (gain) on foreign currency translation

 

3,927

 

 

 

(3,807

)

 

 

3,998

 

 

 

(4,495

)

Total expenses

 

24,482

 

 

 

23,374

 

 

 

70,867

 

 

 

80,290

 

Loss from operations

 

(9,130

)

 

 

(8,779

)

 

 

(24,166

)

 

 

(33,245

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

18

 

 

 

220

 

 

 

165

 

 

 

794

 

Interest expense on notes

 

(1,057

)

 

 

(4,126

)

 

 

(3,212

)

 

 

(5,283

)

Interest expense on promissory notes

 

(1,318

)

 

 

(1,162

)

 

 

(3,858

)

 

 

(3,351

)

Gain on extinguishment of debt

 

 

 

 

3,529

 

 

 

 

 

 

3,529

 

Other income (expense)

 

14

 

 

 

(52

)

 

 

24

 

 

 

(84

)

Total other expense

 

(2,343

)

 

 

(1,591

)

 

 

(6,881

)

 

 

(4,395

)

Loss before provision for income taxes

 

(11,473

)

 

 

(10,370

)

 

 

(31,047

)

 

 

(37,640

)

Benefit for income taxes

 

218

 

 

 

 

 

 

218

 

 

 

 

Net loss

$

(11,255

)

 

$

(10,370

)

 

$

(30,829

)

 

$

(37,640

)

Net loss per share - basic and diluted

$

(0.05

)

 

$

(0.05

)

 

$

(0.14

)

 

$

(0.20

)

Shares used to compute basic and diluted net loss per share

 

229,668

 

 

 

199,906

 

 

 

218,559

 

 

 

191,786

 

 

See notes to condensed consolidated financial statements.

3


 

MANNKIND CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

(In thousands)

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net loss

$

(11,255

)

 

$

(10,370

)

 

$

(30,829

)

 

$

(37,640

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cumulative translation loss

 

 

 

 

(1

)

 

 

(19

)

 

 

(1

)

Comprehensive loss

$

(11,255

)

 

$

(10,371

)

 

$

(30,848

)

 

$

(37,641

)

 

See notes to condensed consolidated financial statements.

 

4


 

MANNKIND CORPORATION AND SUBSIDIARY

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, 2019

 

 

187,030

 

 

$

1,870

 

 

$

2,763,067

 

 

$

(19

)

 

$

(2,940,000

)

 

$

(175,082

)

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

66

 

 

1

 

 

 

1

 

 

 

 

 

 

 

2

 

Issuance of common stock under Employee

   Stock Purchase Plan

 

296

 

 

3

 

 

 

314

 

 

 

 

 

 

 

317

 

Stock-based compensation expense

 

 

 

 

 

 

999

 

 

 

 

 

 

 

999

 

Issuance of common stock pursuant to

   conversion of Senior Convertible Notes

 

386

 

 

4

 

 

 

534

 

 

 

 

 

 

 

538

 

Restricted stock unit award

 

 

 

 

 

 

105

 

 

 

 

 

 

 

105

 

Net loss

 

 

 

 

 

 

 

 

 

 

(14,883

)

 

 

(14,883

)

BALANCE, MARCH 31, 2019

 

 

187,778

 

 

$

1,878

 

 

$

2,765,020

 

 

$

(19

)

 

$

(2,954,883

)

 

$

(188,004

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

 

101

 

 

 

1

 

 

 

14

 

 

 

 

 

 

 

15

 

Stock-based compensation expense

 

 

 

 

 

 

2,568

 

 

 

 

 

 

 

2,568

 

Issuance of common stock in at the market

   offering

 

 

1,568

 

 

 

15

 

 

 

1,835

 

 

 

 

 

 

 

1,850

 

Issuance costs associated with at the

   market offering

 

 

 

 

 

 

(41

)

 

 

 

 

 

 

(41

)

Net loss

 

 

 

 

 

 

 

 

 

 

(12,387

)

 

 

(12,387

)

BALANCE, JUNE 30, 2019

 

 

189,447

 

 

$

1,894

 

 

$

2,769,396

 

 

$

(19

)

 

$

(2,967,270

)

 

$

(195,999

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net issuance of common stock associated

   with stock options and restricted stock

   units

 

 

576

 

 

 

6

 

 

 

25

 

 

 

 

 

 

 

31

 

Issuance of common stock under Employee

   Stock Purchase Plan

 

 

356

 

 

 

4

 

 

 

335

 

 

 

 

 

 

 

339

 

Stock-based compensation expense

 

 

 

 

 

 

 

1,640

 

 

 

 

 

 

 

1,640

 

Issuance of common stock pursuant to

   conversion of Senior Convertible Notes

 

 

4,525

 

 

 

45

 

 

 

4,992

 

 

 

 

 

 

 

5,037

 

Issuance of common stock pursuant to

   conversion of Facility Financing

   Obligation

 

 

4,193

 

 

 

42

 

 

 

4,533

 

 

 

 

 

 

 

4,575

 

Issuance of common stock pursuant to

   conversion of Promissory Notes

 

 

7,143

 

 

 

71

 

 

 

7,929

 

 

 

 

 

 

 

8,000

 

Issuance of common stock in at-the-market

   offering

 

 

168

 

 

 

2

 

 

 

186

 

 

 

 

 

 

 

188

 

Issuance of warrants pursuant to Credit

   facility

 

 

 

 

 

 

1,854

 

 

 

 

 

 

 

1,854

 

Cumulative translation loss

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

(1

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(10,370

)

 

 

(10,370

)

BALANCE, SEPTEMBER 30, 2019

 

 

206,408

 

 

$

2,064

 

 

$

2,790,890

 

 

$

(20

)

 

$

(2,977,640

)

 

$

(184,706

)

 

5


 

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

 

 

 

 

 

Shares