MannKind Corporation Reports 2021 Fourth Quarter and Full Year Financial Results
MannKind Corporation (Nasdaq: MNKD) reported total revenues of $75.4 million for 2021, marking a 16% increase from 2020. Fourth quarter net revenue from Afrezza reached $11.3 million, up 13% year-over-year. Cash and investments stood at $260.7 million as of December 31, 2021. However, the company faced challenges, including a net loss of $80.9 million for the year and a significant increase in SG&A and R&D expenses. The review deadline for Tyvaso DPI has been extended to May 2022, impacting future revenue potential.
- Total revenues for 2021 were $75.4 million, a 16% increase year-over-year.
- Afrezza net revenue for Q4 2021 was $11.3 million, a 13% increase from Q4 2020.
- Cash, cash equivalents, and investments total $260.7 million as of December 31, 2021.
- Net loss increased to $80.9 million for 2021 from $57.2 million in 2020.
- SG&A expenses rose by $18.4 million to $77.4 million in 2021.
- R&D expenses jumped to $12.3 million from $6.2 million in 2020.
Conference Call to Begin Today at 5:00 p.m. (ET)
- 2021 Total Revenues of
$75.4 million ; +16% vs. 2020 - 4Q 2021 Afrezza Net Revenue of
$11.3 million ; +13% vs. 4Q 2020 $260.7 million of Cash, Cash Equivalents and Investments at December 31, 2021- Commenced clofazimine Phase 1 clinical trial in 1Q 2022
- Tyvaso DPI review deadline extended to May 2022
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the fourth quarter and full year ended December 31, 2021.
“We had a solid fourth quarter with Afrezza net revenue hitting a record
Fourth Quarter 2021 Results
Total revenues were
Afrezza gross profit for the fourth quarter of 2021 was
Cost of revenue – collaborations and services increased by
Research and development (“R&D”) expenses for the fourth quarter of 2021 were
Selling, general and administrative (“SG&A”) expenses for the fourth quarter of 2021 were
For the fourth quarter of 2021, 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 fourth quarter of 2021 was
The net loss for the fourth quarter of 2021 was
Twelve Months Ended December 31, 2021
Total revenues were
Afrezza gross profit was
R&D expenses for the year ended December 31, 2021 were
SG&A expenses for the year ended December 31, 2021 were
For the year ended December 31, 2021, 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 year ended December 31, 2021 was
The net loss for the year ended December 31, 2021 was
Cash, cash equivalents, restricted cash, and investments as of December 31, 2021 was
Non-GAAP Measures
To supplement our unaudited condensed consolidated financial statements presented under U.S. generally accepted accounting principles (GAAP), we are presenting certain non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.
These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our unaudited condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
The following table reconciles our gross margin financial measure to a non-GAAP presentation as adjusted for the nonrecurring amendment fee related to an amendment to our Insulin Supply Agreement.
Twelve Months Ended December 31, | |||||||
2021 | 2020 | ||||||
Net revenue — commercial product sales | $ | 39,168 | $ | 32,324 | |||
Less cost of goods sold | (16,833 | ) | (15,084 | ) | |||
GAAP gross profit — Afrezza | 22,335 | 17,240 | |||||
Exclude Amphastar amendment fee | 2,000 | — | |||||
Non-GAAP gross profit — Afrezza | $ | 24,335 | $ | 17,240 | |||
Non-GAAP gross margin | 62 | % | 53 | % |
The following table reconciles our financial measure for net loss and net loss per share as reported in our consolidated statement of operations to a non-GAAP presentation as adjusted for the
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
GAAP to Non-GAAP Net Loss and EPS | ||||||||||||||||
Net loss | $ | (28,061 | ) | $ | (26,411 | ) | $ | (80,926 | ) | $ | (57,240 | ) | ||||
GAAP net loss per share — basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.32 | ) | $ | (0.26 | ) | ||||
Less non-cash loss on extinguishment of debt, net | — | — | 17,200 | — | ||||||||||||
Less Amphastar amendment fee | — | — | 2,000 | — | ||||||||||||
Non-GAAP net loss | $ | (28,061 | ) | $ | (26,411 | ) | $ | (61,726 | ) | $ | (57,240 | ) | ||||
Non-GAAP net loss per share — basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.25 | ) | $ | (0.26 | ) |
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 MannKind’s future commercial growth and pipeline advancement, and MannKind’s ability to commercialize pharmaceutical products. 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 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, the impact of the COVID-19 pandemic, stock price volatility and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as filed with the SEC on November 9, 2021, and under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2021, being filed with the SEC on February 24, 2022. 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
ir@mannkindcorp.com
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
December 31, | ||||||||
2021 | 2020 | |||||||
(In thousands except share and per share data) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 124,184 | $ | 67,005 | ||||
Restricted cash | — | 158 | ||||||
Short-term investments | 79,932 | — | ||||||
Accounts receivable, net | 4,994 | 4,218 | ||||||
Inventory | 7,152 | 4,973 | ||||||
Prepaid expenses and other current assets | 3,482 | 3,122 | ||||||
Total current assets | 219,744 | 79,476 | ||||||
Property and equipment, net | 36,612 | 25,867 | ||||||
Long-term investments | 56,619 | — | ||||||
Other assets | 8,186 | 3,265 | ||||||
Total assets | $ | 321,161 | $ | 108,608 | ||||
LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 6,956 | $ | 5,582 | ||||
Accrued expenses and other current liabilities | 27,419 | 19,707 | ||||||
Financing liability — current | 6,977 | — | ||||||
Paycheck Protection Program loan — current | — | 4,061 | ||||||
Deferred revenue — current | 827 | 33,275 | ||||||
Recognized loss on purchase commitments — current | 6,170 | 11,080 | ||||||
Total current liabilities | 48,349 | 73,705 | ||||||
Promissory notes | 18,425 | 63,027 | ||||||
Accrued interest — promissory notes | 404 | 4,150 | ||||||
Financing liability — long term | 93,525 | — | ||||||
Long-term Midcap credit facility | 38,833 | 49,335 | ||||||
Senior convertible notes | 223,944 | — | ||||||
Recognized loss on purchase commitments — long term | 76,659 | 84,208 | ||||||
Operating lease liability | 1,040 | 1,202 | ||||||
Deferred revenue — long term | 19,543 | 1,662 | ||||||
Milestone rights liability | 4,838 | 5,926 | ||||||
2024 convertible notes | — | 5,000 | ||||||
Paycheck Protection Program loan — long term | — | 812 | ||||||
Deposits from customer | 4,950 | — | ||||||
Total liabilities | 530,510 | 289,027 | ||||||
Stockholders' deficit: | ||||||||
Undesignated preferred stock, | — | — | ||||||
Common stock, | 2,515 | 2,421 | ||||||
Additional paid-in capital | 2,918,205 | 2,866,303 | ||||||
Accumulated other comprehensive loss | — | — | ||||||
Accumulated deficit | (3,130,069 | ) | (3,049,143 | ) | ||||
Total stockholders' deficit | (209,349 | ) | (180,419 | ) | ||||
Total liabilities and stockholders' deficit | $ | 321,161 | $ | 108,608 |
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Revenues: | ||||||||||||||||
Net revenue — commercial product sales | $ | 11,340 | $ | 10,064 | $ | 39,168 | $ | 32,324 | ||||||||
Revenue — collaborations and services | 1,175 | 8,379 | 36,274 | 32,820 | ||||||||||||
Total revenues | 12,515 | 18,443 | 75,442 | 65,144 | ||||||||||||
Expenses: | ||||||||||||||||
Cost of goods sold | 4,295 | 3,652 | 16,833 | 15,084 | ||||||||||||
Cost of revenue — collaborations and services | 7,139 | 2,631 | 22,024 | 9,557 | ||||||||||||
Research and development | 3,886 | 1,545 | 12,312 | 6,248 | ||||||||||||
Acquired In-Process R&D | — | 13,233 | — | 13,233 | ||||||||||||
Selling, general and administrative | 22,727 | 17,121 | 77,417 | 59,040 | ||||||||||||
Impairment of assets | — | — | 106 | 1,889 | ||||||||||||
(Gain) loss on foreign currency translation | (1,564 | ) | 4,008 | (6,567 | ) | 8,006 | ||||||||||
Loss on purchase commitments | — | — | 339 | — | ||||||||||||
Total expenses | 36,483 | 42,190 | 122,464 | 113,057 | ||||||||||||
Loss from operations | (23,968 | ) | (23,747 | ) | (47,022 | ) | (47,913 | ) | ||||||||
Other (expense) income: | ||||||||||||||||
Interest income | 48 | 2 | 112 | 167 | ||||||||||||
Interest expense on financing liability | (1,373 | ) | — | (1,373 | ) | — | ||||||||||
Interest expense on notes | (2,769 | ) | (2,401 | ) | (15,204 | ) | (9,471 | ) | ||||||||
Loss on extinguishment of debt | — | (264 | ) | (17,200 | ) | (264 | ) | |||||||||
Other (expense) income | 1 | (1 | ) | (239 | ) | 23 | ||||||||||
Total other expense | (4,093 | ) | (2,664 | ) | (33,904 | ) | (9,545 | ) | ||||||||
Loss before income tax expense | (28,061 | ) | (26,411 | ) | (80,926 | ) | (57,458 | ) | ||||||||
Benefit from income taxes | — | — | — | 218 | ||||||||||||
Net loss | $ | (28,061 | ) | $ | (26,411 | ) | $ | (80,926 | ) | $ | (57,240 | ) | ||||
Net loss per share — basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.32 | ) | $ | (0.26 | ) | ||||
Shares used to compute net loss per share — basic and diluted | 251,083 | 234,575 | 249,244 | 222,585 |
FAQ
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