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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, 2023
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:
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Title of each class |
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Trading Symbol(s) |
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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.
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Large accelerated filer |
☒ |
Accelerated filer |
☐ |
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|
|
|
Non-accelerated filer |
☐ |
Smaller reporting company |
☐ |
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|
|
|
|
|
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 27, 2023, there were 269,574,654 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, 2023
TABLE OF CONTENTS
1
PART 1: FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended September 30, |
|
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Nine Months Ended September 30, |
|
|
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2023 |
|
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2022 |
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|
2023 |
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2022 |
|
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|
(In thousands except per share data) |
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Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue – commercial product sales |
|
$ |
17,927 |
|
|
$ |
16,259 |
|
|
$ |
53,834 |
|
|
$ |
38,807 |
|
Revenue – collaborations and services |
|
|
13,108 |
|
|
|
10,346 |
|
|
|
35,705 |
|
|
|
18,380 |
|
Royalties – collaborations |
|
|
20,218 |
|
|
|
6,220 |
|
|
|
50,951 |
|
|
|
6,524 |
|
Total revenues |
|
|
51,253 |
|
|
|
32,825 |
|
|
|
140,490 |
|
|
|
63,711 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
3,995 |
|
|
|
5,021 |
|
|
|
14,749 |
|
|
|
11,922 |
|
Cost of revenue – collaborations and services |
|
|
10,259 |
|
|
|
12,439 |
|
|
|
29,955 |
|
|
|
29,451 |
|
Research and development |
|
|
9,989 |
|
|
|
4,136 |
|
|
|
22,047 |
|
|
|
12,565 |
|
Selling |
|
|
13,440 |
|
|
|
13,541 |
|
|
|
40,752 |
|
|
|
42,137 |
|
General and administrative |
|
|
10,538 |
|
|
|
9,097 |
|
|
|
33,027 |
|
|
|
27,241 |
|
Gain on foreign currency transaction |
|
|
(2,065 |
) |
|
|
(1,799 |
) |
|
|
(860 |
) |
|
|
(8,285 |
) |
Total expenses |
|
|
46,156 |
|
|
|
42,435 |
|
|
|
139,670 |
|
|
|
115,031 |
|
Income (loss) from operations |
|
|
5,097 |
|
|
|
(9,610 |
) |
|
|
820 |
|
|
|
(51,320 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
1,580 |
|
|
|
663 |
|
|
|
4,429 |
|
|
|
1,556 |
|
Interest expense on financing liability |
|
|
(2,459 |
) |
|
|
(2,466 |
) |
|
|
(7,332 |
) |
|
|
(7,280 |
) |
Interest expense |
|
|
(2,815 |
) |
|
|
(2,812 |
) |
|
|
(12,474 |
) |
|
|
(12,202 |
) |
Gain on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
932 |
|
|
|
— |
|
Other income (expense) |
|
|
318 |
|
|
|
(207 |
) |
|
|
286 |
|
|
|
(207 |
) |
Total other expense |
|
|
(3,376 |
) |
|
|
(4,822 |
) |
|
|
(14,159 |
) |
|
|
(18,133 |
) |
Income (loss) before income tax expense |
|
|
1,721 |
|
|
|
(14,432 |
) |
|
|
(13,339 |
) |
|
|
(69,453 |
) |
Benefit from income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net income (loss) |
|
$ |
1,721 |
|
|
$ |
(14,432 |
) |
|
$ |
(13,339 |
) |
|
$ |
(69,453 |
) |
Net income (loss) per share – basic |
|
$ |
0.01 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.27 |
) |
Weighted average shares used to compute net income (loss) per share – basic |
|
|
268,732 |
|
|
|
259,300 |
|
|
|
266,126 |
|
|
|
254,974 |
|
Net income (loss) per share – diluted |
|
$ |
0.01 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.27 |
) |
Weighted average shares used to compute net income (loss) per share – diluted |
|
|
323,770 |
|
|
|
259,300 |
|
|
|
266,126 |
|
|
|
254,974 |
|
See notes to condensed consolidated financial statements.
2
MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(In thousands) |
|
Net income (loss) |
|
$ |
1,721 |
|
|
$ |
(14,432 |
) |
|
$ |
(13,339 |
) |
|
$ |
(69,453 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
443 |
|
|
|
(1,206 |
) |
Comprehensive income (loss) |
|
$ |
1,721 |
|
|
$ |
(14,432 |
) |
|
$ |
(12,896 |
) |
|
$ |
(70,659 |
) |
See notes to condensed consolidated financial statements.
3
MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(In thousands except share and per share data) |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
83,016 |
|
|
$ |
69,767 |
|
Short-term investments |
|
|
58,000 |
|
|
|
101,079 |
|
Accounts receivable, net |
|
|
21,822 |
|
|
|
16,801 |
|
Inventory |
|
|
27,117 |
|
|
|
21,772 |
|
Prepaid expenses and other current assets |
|
|
35,620 |
|
|
|
25,477 |
|
Total current assets |
|
|
225,575 |
|
|
|
234,896 |
|
Property and equipment, net |
|
|
80,411 |
|
|
|
45,126 |
|
Goodwill |
|
|
1,931 |
|
|
|
2,428 |
|
Other intangible asset |
|
|
1,093 |
|
|
|
1,153 |
|
Long-term investments |
|
|
3,271 |
|
|
|
1,961 |
|
Other assets |
|
|
8,047 |
|
|
|
9,718 |
|
Total assets |
|
$ |
320,328 |
|
|
$ |
295,282 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
16,754 |
|
|
$ |
11,052 |
|
Accrued expenses and other current liabilities |
|
|
32,098 |
|
|
|
35,553 |
|
Financing liability – current |
|
|
9,747 |
|
|
|
9,565 |
|
Midcap credit facility – current |
|
|
20,000 |
|
|
|
— |
|
Deferred revenue – current |
|
|
3,670 |
|
|
|
1,733 |
|
Recognized loss on purchase commitments – current |
|
|
14,105 |
|
|
|
9,393 |
|
Total current liabilities |
|
|
96,374 |
|
|
|
67,296 |
|
Mann Group convertible note |
|
|
8,829 |
|
|
|
8,829 |
|
Accrued interest – Mann Group convertible note |
|
|
57 |
|
|
|
55 |
|
Financing liability – long term |
|
|
94,375 |
|
|
|
94,512 |
|
Midcap credit facility – long term |
|
|
17,921 |
|
|
|
39,264 |
|
Senior convertible notes |
|
|
226,487 |
|
|
|
225,397 |
|
Recognized loss on purchase commitments – long term |
|
|
50,534 |
|
|
|
62,916 |
|
Operating lease liability |
|
|
4,289 |
|
|
|
5,343 |
|
Deferred revenue – long term |
|
|
69,469 |
|
|
|
37,684 |
|
Milestone liabilities |
|
|
3,772 |
|
|
|
4,524 |
|
Total liabilities |
|
|
572,107 |
|
|
|
545,820 |
|
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, 2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value – 800,000,000 and 400,000,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively, and 269,543,539 and 263,793,305 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively |
|
|
2,695 |
|
|
|
2,638 |
|
Additional paid-in capital |
|
|
2,975,891 |
|
|
|
2,964,293 |
|
Accumulated other comprehensive income |
|
|
443 |
|
|
|
— |
|
Accumulated deficit |
|
|
(3,230,808 |
) |
|
|
(3,217,469 |
) |
Total stockholders' deficit |
|
|
(251,779 |
) |
|
|
(250,538 |
) |
Total liabilities and stockholders' deficit |
|
$ |
320,328 |
|
|
$ |
295,282 |
|
See notes to condensed consolidated financial statements.
4
MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated Other |
|
|
|
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Paid-in Capital |
|
|
Comprehensive Loss |
|
|
Accumulated Deficit |
|
|
Total |
|
|
|
(In thousands) |
|
BALANCE, JANUARY 1, 2022 |
|
|
251,478 |
|
|
$ |
2,515 |
|
|
$ |
2,918,205 |
|
|
$ |
— |
|
|
$ |
(3,130,069 |
) |
|
$ |
(209,349 |
) |
Net issuance of common stock associated with stock options and restricted stock units |
|
|
450 |
|
|
|
4 |
|
|
|
125 |
|
|
|
— |
|
|
|
— |
|
|
|
129 |
|
Issuance of common stock under the employee stock purchase plan |
|
|
233 |
|
|
|
2 |
|
|
|
738 |
|
|
|
— |
|
|
|
— |
|
|
|
740 |
|
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
2,806 |
|
|
|
— |
|
|
|
— |
|
|
|
2,806 |
|
Issuance of common stock from market price stock purchase plan |
|
|
252 |
|
|
|
3 |
|
|
|
681 |
|
|
|
— |
|
|
|
— |
|
|
|
684 |
|
Cumulative loss on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,076 |
) |
|
|
— |
|
|
|
(1,076 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(25,998 |
) |
|
|
(25,998 |
) |
BALANCE, MARCH 31, 2022 |
|
|
252,413 |
|
|
$ |
2,524 |
|
|
$ |
2,922,555 |
|
|
$ |
(1,076 |
) |
|
$ |
(3,156,067 |
) |
|
$ |
(232,064 |
) |
Issuance of common stock pursuant to conversion of Mann Group convertible note |
|
|
3,838 |
|
|
|
39 |
|
|
|
9,557 |
|
|
|
— |
|
|
|
— |
|
|
|
9,596 |
|
Issuance of common stock pursuant to conversion of the Mann Group convertible note interest |
|
|
193 |
|
|
|
2 |
|
|
|
518 |
|
|
|
— |
|
|
|
— |
|
|
|
520 |
|
Net issuance of common stock associated with stock options and restricted stock units |
|
|
833 |
|
|
|
8 |
|
|
|
(385 |
) |
|
|
— |
|
|
|
— |
|
|
|
(377 |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
4,422 |
|
|
|
— |
|
|
|
— |
|
|
|
4,422 |
|
Cumulative loss on available-for-sale securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(130 |
) |
|
|
— |
|
|
|
(130 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(29,023 |
) |
|
|
(29,023 |
) |
BALANCE, JUNE 30, 2022 |
|
|
257,277 |
|
|
$ |
2,573 |
|
|
$ |
2,936,667 |
|
|
$ |
(1,206 |
) |
|
$ |
(3,185,090 |
) |
|
$ |
(247,056 |
) |
Issuance of common stock associated with at-the-market placement |
|
|
5,060 |
|
|
|
51 |
|
|
|
19,739 |
|
|
|
— |
|
|
|
— |
|
|
|
19,790 |
|
Issuance costs associated with at-the-market placement |
|
|
— |
|
|
|
— |
|
|
|
(381 |
) |
|
|
— |
|
|
|
— |
|
|
|
(381 |
) |
Issuance of common stock pursuant to conversion of the Mann Group convertible note interest |
|
|
26 |
|
|
|
— |
|
|
|
99 |
|
|
|
— |
|
|
|
— |
|
|
|
99 |
|
Issuance of common stock under Employee Stock Purchase Plan |
|
|
298 |
|
|
|
3 |
|
|
|
870 |
|
|
|
— |
|
|
|
— |
|
|
|
873 |
|
Net issuance of common stock associated with stock options and restricted stock units |
|
|
495 |
|
|
|
5 |
|
|
|
(197 |
) |
|
|
— |
|
|
|
— |
|
|
|
(192 |
) |
Stock-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
3,622 |
|
|
|
— |
|
|
|
— |
|
|
|
3,622 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(14,432 |
) |
|
|
(14,432 |
) |
BALANCE, SEPTEMBER 30, 2022 |
|
|
263,156 |
|
|
$ |
2,632 |
|
|
$ |
2,960,419 |
|
|
$ |
(1,206 |
) |
|
$ |
(3,199,522 |
) |
|
$ |
(237,677 |
) |
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated Other |
|
|
|
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Paid-in Capital |
|
|
Comprehensive Loss |
|
|
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 placement |
|
|
269 |
|
|
|
3 |
|
|
|
1,196 |
|
|
|
— |
|
|
|
— |
|
|
|
1,199 |
|
Issuance costs associated with at-the-market placement |
|
|
— |
|
|
|
— |
|
|
|
(24 |
) |
|
|
— |
|
|
|
— |
|
|