Mannkind Corporation Reports 2023 First Quarter Financial Results
- 1Q 2023 total revenues increased by 239% compared to 1Q 2022
- Revenues associated with Tyvaso DPI were $23 million
- Loss from operations decreased by 72% to $6 million
- The company had $167 million in cash, cash equivalents, and investments at the end of March 2023
- None.
Conference Call to Begin Today at 5:00 p.m. (ET)
- 1Q 2023 Total Revenues of
$41 million ; +239% vs. 1Q 2022 - 1Q 2023 Revenues associated with Tyvaso DPI of
$23 million - 1Q 2023 Loss from operations decreased
72% vs. 1Q 2022 to$6 million $167 million of Cash, Cash Equivalents and Investments at March 31, 2023
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended March 31, 2023.
“Demand for Tyvaso DPI® has been very strong, which resulted in
Revenue Highlights
Three Months Ended March 31, | |||||||||||
2023 | 2022 | $ Change | % Change | ||||||||
(Dollars in thousands) | |||||||||||
Net revenue – Afrezza | $ | 12,423 | $ | 9,826 | $ | 2,597 | 26 | % | |||
Net revenue – V-Go | 5,139 | — | $ | 5,139 | * | ||||||
Revenue – collaborations and services | 11,386 | 2,166 | $ | 9,220 | 426 | % | |||||
Royalties – collaborations | 11,678 | — | $ | 11,678 | * | ||||||
Total revenues | $ | 40,626 | $ | 11,992 | $ | 28,634 | 239 | % |
___________________
* Not meaningful
Afrezza® net revenue for the first quarter of 2023 increased compared to the same period in 2022 as a result of higher product demand, higher price (including a more favorable gross-to-net adjustment) and a more favorable cartridge mix. V-Go® was acquired in the second quarter of 2022. The increase in collaborations and services revenue reflected that the commercial manufacturing of Tyvaso DPI had not yet commenced in the prior period. Royalties related to Tyvaso DPI, launched in the second quarter of 2022 by United Therapeutics (“UT”), continued to grow based on strong patient demand.
Commercial product gross margin in the first quarter of 2023 was
Cost of revenue – collaborations and services for the first quarter of 2023 was
Research and development expenses for the first quarter of 2023 were
Selling expenses for the first quarter of 2023 were
General and administrative expenses for the first quarter of 2023 were
Interest expense on financing liability was
Interest expense on notes was
Cash, cash equivalents and investments as of March 31, 2023 were
Conference Call
MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind's website for 14 days.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.
We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation.
With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, Twitter or Instagram.
Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding MannKind’s pipeline advancement, including the planned launch of MannKind's inhaled clofazimine trial for patients in the second half of 2023. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with manufacturing and supply, risks associated with product commercialization, risks associated with developing product candidates, risks associated with MannKind’s ability to manage its existing cash resources or raise additional cash resources, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on February 23, 2023, and under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, being filed with the SEC later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
Tyvaso DPI is a trademark of United Therapeutics Corporation.
AFREZZA, MANNKIND, and V-GO are registered trademarks of MannKind Corporation.
MannKind Contact:
Rose Alinaya, Investor Relations
(818) 661-5000
IR@mannkindcorp.com
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended March 31, | |||||||
2023 | 2022 | ||||||
(In thousands except per share data) | |||||||
Revenues: | |||||||
Net revenue – commercial product sales | $ | 17,562 | $ | 9,826 | |||
Revenue – collaborations and services | 11,386 | 2,166 | |||||
Royalties – collaborations | 11,678 | — | |||||
Total revenues | 40,626 | 11,992 | |||||
Expenses: | |||||||
Cost of goods sold | 5,530 | 2,284 | |||||
Cost of revenue – collaborations and services | 10,683 | 8,714 | |||||
Research and development | 5,605 | 3,536 | |||||
Selling | 13,310 | 12,728 | |||||
General and administrative | 10,542 | 7,969 | |||||
Loss (gain) on foreign currency transaction | 954 | (1,983 | ) | ||||
Total expenses | 46,624 | 33,248 | |||||
Loss from operations | (5,998 | ) | (21,256 | ) | |||
Other (expense) income: | |||||||
Interest income, net | 1,302 | 377 | |||||
Interest expense on financing liability | (2,424 | ) | (2,371 | ) | |||
Interest expense on notes | (2,786 | ) | (2,748 | ) | |||
Other income | 111 | — | |||||
Total other expense | (3,797 | ) | (4,742 | ) | |||
Loss before income tax expense | (9,795 | ) | (25,998 | ) | |||
Benefit from income taxes | — | — | |||||
Net loss | $ | (9,795 | ) | $ | (25,998 | ) | |
Net loss per share – basic and diluted | $ | (0.04 | ) | $ | (0.10 | ) | |
Shares used to compute net loss per share – basic and diluted | 263,969 | 251,887 | |||||
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, | |||||||
2023 | 2022 | ||||||
(In thousands except share and per share data) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 85,869 | $ | 69,767 | |||
Short-term investments | 80,273 | 101,079 | |||||
Accounts receivable, net | 19,714 | 16,801 | |||||
Inventory | 21,998 | 21,772 | |||||
Prepaid expenses and other current assets | 15,445 | 25,477 | |||||
Total current assets | 223,299 | 234,896 | |||||
Property and equipment, net | 54,837 | 45,126 | |||||
Goodwill | 1,998 | 2,428 | |||||
Other intangible asset | 1,133 | 1,153 | |||||
Long-term investments | 492 | 1,961 | |||||
Other assets | 16,378 | 9,718 | |||||
Total assets | $ | 298,137 | $ | 295,282 | |||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 13,889 | $ | 11,052 | |||
Accrued expenses and other current liabilities | 32,995 | 35,553 | |||||
Financing liability – current | 9,626 | 9,565 | |||||
Midcap credit facility – current | 11,667 | — | |||||
Deferred revenue – current | 2,316 | 1,733 | |||||
Recognized loss on purchase commitments – current | 11,360 | 9,393 | |||||
Total current liabilities | 81,853 | 67,296 | |||||
Mann Group convertible note | 8,829 | 8,829 | |||||
Accrued interest – Mann Group convertible note | 54 | 55 | |||||
Financing liability – long term | 94,441 | 94,512 | |||||
Midcap credit facility | 27,704 | 39,264 | |||||
Senior convertible notes | 225,761 | 225,397 | |||||
Recognized loss on purchase commitments – long term | 59,829 | 62,916 | |||||
Operating lease liability | 4,879 | 5,343 | |||||
Deferred revenue – long term | 45,659 | 37,684 | |||||
Milestone liabilities | 4,524 | 4,524 | |||||
Deposits from customer | — | — | |||||
Total liabilities | 553,533 | 545,820 | |||||
Stockholders' deficit: | |||||||
Undesignated preferred stock, authorized; no shares issued or outstanding as of March 31, 2023 and December 31, 2022 | — | — | |||||
Common stock, 264,278,760 and 263,793,305 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 2,643 | 2,638 | |||||
Additional paid-in capital | 2,969,225 | 2,964,293 | |||||
Accumulated deficit | (3,227,264 | ) | (3,217,469 | ) | |||
Total stockholders' deficit | (255,396 | ) | (250,538 | ) | |||
Total liabilities and stockholders' deficit | $ | 298,137 | $ | 295,282 |
FAQ
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