MannKind Corporation Reports 2022 First Quarter Financial Results
MannKind Corporation (Nasdaq: MNKD) reported Q1 2022 financial results with Afrezza net revenue of $9.8 million, reflecting a 21% increase from Q1 2021. The company's gross profit rose 99% to $7.5 million, supported by a 77% gross margin. Total revenues were $12.0 million, impacted by a $7.2 million drop in collaborations and services revenue due to completed R&D services with United Therapeutics. Net loss grew to $26.0 million, or $0.10 per share, attributed to reduced collaboration revenue and increased costs. Cash reserves stood at $233.0 million as of March 31, 2022.
- Afrezza net revenue increased by 21% year-over-year to $9.8 million.
- Gross profit rose by 99% compared to Q1 2021, reaching $7.5 million.
- Afrezza gross margin improved to 77%, up from 47% in 2021.
- Net loss for Q1 2022 increased to $26.0 million from $12.9 million in Q1 2021.
- Collaboration and services revenue decreased by $7.2 million compared to Q1 2021.
Conference Call to Begin Today at 5:00 p.m. (ET)
- 1Q 2022 Afrezza Net Revenue of
$9.8 million ; +21% vs. 1Q 2021 - 1Q 2022 Afrezza Gross Margin
77% ; Gross Profit +99% vs 1Q 2021 $233.0 million of Cash, Cash Equivalents, and Investments at March 31, 2022- Tyvaso DPI PDUFA date May 2022
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended March 31, 2022.
“As we approach the FDA action date for Tyvaso DPI, our company is focused on supporting United Therapeutics in their planned commercial launch,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “Our endocrine business unit execution has resulted in Afrezza net revenue growth of
Total revenues were
Afrezza gross profit for the first quarter of 2022 was
Cost of revenue – collaborations and services increased by
Research and development expenses for the first quarter of 2022 were
Selling, general and administrative expenses for the first quarter of 2022 were
For the first quarter of 2022, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was
Interest expense on financing liability was
Interest expense on debt for the first quarter of 2022 was
The net loss for the first quarter of 2022 was
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 Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company’s partner, Biomm SA. MannKind was established in 1991, and is located in Danbury, Conn., and Westlake Village, Calif. The Company also employs field sales and medical representatives across the U.S. Please visit mannkindcorp.com to learn more.
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 the expected PDUFA date for Tyvaso DPI and our ability to support United Therapeutics in its planned commercial launch of Tyvaso DPI. 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: the FDA may not complete its review of the NDA for Tyvaso DPI on the timeframe expected for various reasons, including due to disruptions that may be caused by personnel shortages, citizen petitions and the COVID-19 pandemic; the FDA may determine not to approve Tyvaso DPI; and if we fail as an effective manufacturing organization, we may be unable to support commercialization of Tyvaso DPI, if approved. These and other are 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, 2021, filed with the SEC on February 24, 2022, and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, 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 an investigational combination product that is not approved for any use in any country. The Tyvaso DPI tradename is pending final FDA review. TYVASO DPI is a trademark of United Therapeutics Corporation.
AFREZZA is a registered trademark of MannKind Corporation.
MannKind Contact:
Rose Alinaya, Investor Relations
(818) 661-5000
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
March 31, 2022 | December 31, 2021 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 67,243 | $ | 124,184 | |||
Short-term investments | 95,203 | 79,932 | |||||
Accounts receivable, net | 9,823 | 4,739 | |||||
Inventory | 8,044 | 7,152 | |||||
Prepaid expenses and other current assets | 3,952 | 3,482 | |||||
Total current assets | 184,265 | 219,489 | |||||
Property and equipment, net | 41,453 | 36,612 | |||||
Long-term investments | 70,542 | 56,619 | |||||
Other assets | 12,058 | 8,441 | |||||
Total assets | $ | 308,318 | $ | 321,161 | |||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 8,702 | $ | 6,956 | |||
Accrued expenses and other current liabilities | 27,131 | 27,419 | |||||
Financing liability — current | 9,410 | 6,977 | |||||
Deferred revenue — current | 1,307 | 827 | |||||
Recognized loss on purchase commitments — current | 6,944 | 6,170 | |||||
Total current liabilities | 53,494 | 48,349 | |||||
Senior convertible notes | 224,307 | 223,944 | |||||
Midcap credit facility | 38,939 | 38,833 | |||||
Promissory notes | 18,425 | 18,425 | |||||
Accrued interest — promissory notes | 520 | 404 | |||||
Financing liability — long term | 93,463 | 93,525 | |||||
Recognized loss on purchase commitments — long term | 72,400 | 76,659 | |||||
Operating lease liability | 826 | 1,040 | |||||
Deferred revenue — long term | 26,116 | 19,543 | |||||
Milestone rights liability | 4,838 | 4,838 | |||||
Deposits from customer | 7,054 | 4,950 | |||||
Total liabilities | 540,382 | 530,510 | |||||
Stockholders' deficit: | |||||||
Undesignated preferred stock, no shares issued or outstanding as of March 31, 2022 and December 31, 2021 | — | — | |||||
Common stock, 252,413,434 and 251,477,562 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 2,524 | 2,515 | |||||
Additional paid-in capital | 2,922,555 | 2,918,205 | |||||
Accumulated other comprehensive loss | (1,076 | ) | — | ||||
Accumulated deficit | (3,156,067 | ) | (3,130,069 | ) | |||
Total stockholders' deficit | (232,064 | ) | (209,349 | ) | |||
Total liabilities and stockholders' deficit | $ | 308,318 | $ | 321,161 | |||
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended March 31, | |||||||
2022 | 2021 | ||||||
Revenues: | |||||||
Net revenue — commercial product sales | $ | 9,826 | $ | 8,099 | |||
Revenue — collaborations and services | 2,166 | 9,337 | |||||
Total revenues | 11,992 | 17,436 | |||||
Expenses: | |||||||
Cost of goods sold | 2,284 | 4,315 | |||||
Cost of revenue — collaborations and services | 8,714 | 3,295 | |||||
Research and development | 3,536 | 2,442 | |||||
Selling, general and administrative | 20,697 | 17,413 | |||||
Gain on foreign currency translation | (1,983 | ) | (3,838 | ) | |||
Total expenses | 33,248 | 23,627 | |||||
Loss from operations | (21,256 | ) | (6,191 | ) | |||
Other (expense) income: | |||||||
Interest income, net | 377 | 3 | |||||
Interest expense on financing liability | (2,371 | ) | — | ||||
Interest expense on notes | (2,748 | ) | (6,452 | ) | |||
Other expense | — | (276 | ) | ||||
Total other expense | (4,742 | ) | (6,725 | ) | |||
Loss before provision for income taxes | (25,998 | ) | (12,916 | ) | |||
Provision for income taxes | — | — | |||||
Net loss | $ | (25,998 | ) | $ | (12,916 | ) | |
Net loss per share - basic and diluted | $ | (0.10 | ) | $ | (0.05 | ) | |
Shares used to compute net loss per share - basic and diluted | 251,887 | 246,631 |
FAQ
What were MannKind's earnings for Q1 2022?
How much did Afrezza generate in revenue during Q1 2022?
What is the status of MannKind's collaboration with United Therapeutics as of Q1 2022?