MannKind Corporation Reports 2021 Second Quarter Financial Results
MannKind Corporation (MNKD) reported Q2 2021 revenues of $23.3 million, a 54% increase year-over-year, driven by Afrezza net revenue of $10.0 million. The company reported a net loss of $35.5 million, or $0.14 per share, compared to a net loss of $10.3 million in Q2 2020. Gross profit from Afrezza surged 68% to $5.6 million, enhancing gross margin to 56% (or 76% on a non-GAAP basis). Cash equivalents amounted to $201.4 million as of June 30, 2021, bolstered by $230 million in convertible notes issued earlier this year.
- Total revenue increased 54% year-over-year to $23.3 million.
- Afrezza net revenue rose by 43% to $10.0 million.
- Gross profit increased 68% to $5.6 million, with a gross margin of 56% (76% non-GAAP).
- Cash and investments reached $201.4 million, offering financial stability.
- Net loss widened to $35.5 million, up from $10.3 million in Q2 2020.
- SG&A expenses rose significantly by 47% to $20.1 million.
Conference Call to Begin Today at 5:00 PM ET
- 2Q 2021 Total Revenues of
$23.3 million ; +54% vs. 2Q 2020 - 2Q 2021 Afrezza Net Revenue of
$10.0 million ; +43% vs. 2Q 2020 $201.4 million of Cash, Cash Equivalents and Investments at June 30, 2021
WESTLAKE VILLAGE, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today reported financial results for the quarter and six months ended June 30, 2021.
“I am really proud of how our team has executed so far in 2021 supporting the growth of Afrezza and preparing for the potential commercial launch of Tyvaso DPI,” said Michael Castagna, Chief Executive Officer of MannKind Corporation. “With the issuance of the convertible debt in the first quarter and the pay-down and restructuring of our legacy debt in the second quarter, we have a stronger balance sheet with lower interest expense which sets the company up for commercial growth and pipeline advancement.”
Second Quarter 2021 Results
Total revenues were
Afrezza gross profit for the second quarter of 2021 was
Research and development (“R&D”) expenses for the second quarter of 2021 were
Selling, general and administrative (“SG&A”) expenses for the second quarter of 2021 were
For the second quarter of 2021, the loss on foreign currency translation for insulin purchase commitments denominated in Euros was
Interest expense on debt for the second quarter of 2021 was
Loss on extinguishment of debt, a non-cash expense item, for the three months ended June 30, 2021 was
The net loss for the second quarter of 2021 was
Six Months June 30, 2021
Total revenues were
Afrezza gross profit for the six months ended June 30, 2021 was
R&D expenses for the six months ended June 30, 2021 were
SG&A expenses for the six months ended June 30, 2021 were
For the six months ended June 30, 2021, the gain on foreign currency translation for insulin purchase commitments denominated in Euros was
Interest expense on debt for the six months ended June 30, 2021 was
Non-cash loss on extinguishment of debt for the six months ended June 30, 2021 was
The net loss for the six months ended June 30, 2021 was
Cash, cash equivalents, and investments at June 30, 2021 were
Non-GAAP Measures
Certain financial information contained in this press release is presented on both a reported basis (GAAP) and a Non-GAAP basis. Reported results were prepared in accordance with GAAP whereas Non-GAAP measures exclude items described in the reconciliation tables below. Non-GAAP financial information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current and past periods. The Non-GAAP financial measures are in addition to, not a substitute for, or superior to measures of financial performance compared in accordance with GAAP.
The following tables reconcile 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.
Three Months Ended June 30, | |||||||||||||||
(In thousands) | 2021 | 2020 | $ Change | % Change | |||||||||||
Net revenue — Afrezza | $ | 9,976 | $ | 6,985 | $ | 2,991 | 43 | % | |||||||
Less cost of goods sold | (4,411 | ) | (3,677 | ) | $ | (734 | ) | 20 | % | ||||||
GAAP gross profit — Afrezza | 5,565 | 3,308 | $ | 2,257 | 68 | % | |||||||||
Exclude Amphastar amendment fee | 2,000 | — | $ | 2,000 | * | ||||||||||
Non-GAAP gross profit — Afrezza | $ | 7,565 | $ | 3,308 | $ | 4,257 | 129 | % | |||||||
Non-GAAP gross margin | 76 | % | 47 | % |
Six Months Ended June 30, | |||||||||||||||
2021 | 2020 | $ Change | % Change | ||||||||||||
Net revenue — Afrezza | $ | 18,075 | $ | 14,985 | $ | 3,090 | 21 | % | |||||||
Less cost of goods sold | (8,726 | ) | (7,841 | ) | $ | 885 | 11 | % | |||||||
GAAP gross profit — Afrezza | 9,349 | 7,144 | $ | 2,205 | 31 | % | |||||||||
Exclude Amphastar amendment fee | 2,000 | — | $ | 2,000 | * | ||||||||||
Non-GAAP gross profit — Afrezza | $ | 11,349 | $ | 7,144 | $ | 4,205 | 59 | % | |||||||
Non-GAAP gross margin | 63 | % | 48 | % |
____________________
* Not meaningful
The following tables reconcile our financial measure for net loss and EPS as reported in our condensed consolidated statement of operations to a non-GAAP presentation as adjusted for the
Three Months Ended June 30, | |||||||||||||||
(In thousands, except per share data) | 2021 | 2020 | $ Change | % Change | |||||||||||
GAAP to Non-GAAP Net Loss and EPS | |||||||||||||||
Net loss | $ | (35,523 | ) | $ | (10,252 | ) | $ | 25,271 | 246 | % | |||||
Net loss per share - basic and diluted | $ | (0.14 | ) | $ | (0.05 | ) | $ | 0.09 | 180 | % | |||||
Less non-cash loss on extinguishment of debt(1) | 22,130 | — | $ | 22,130 | * | ||||||||||
Non-GAAP net loss | $ | (13,393 | ) | $ | (10,252 | ) | $ | 3,141 | 31 | % | |||||
Non-GAAP net loss per share - basic and diluted | $ | (0.05 | ) | $ | (0.05 | ) | $ | — | — | % | |||||
Shares used to compute non-GAAP basic and diluted net loss per share | 249,295 | 213,880 | 35,415 | 17 | % |
Six Months Ended June 30, | |||||||||||||||
2021 | 2020 | $ Change | % Change | ||||||||||||
GAAP to Non-GAAP Net Loss and EPS | |||||||||||||||
Net loss | $ | (48,439 | ) | $ | (19,574 | ) | $ | 28,865 | 147 | % | |||||
Net loss per share - basic and diluted | $ | (0.20 | ) | $ | (0.09 | ) | $ | 0.11 | 122 | % | |||||
Less non-cash loss on extinguishment of debt(1) | 22,130 | — | $ | 22,130 | * | ||||||||||
Non-GAAP net loss | $ | (26,309 | ) | $ | (19,574 | ) | $ | 6,735 | 34 | % | |||||
Non-GAAP net loss per share - basic and diluted | $ | (0.11 | ) | $ | (0.09 | ) | $ | 0.02 | 22 | % | |||||
Shares used to compute non-GAAP basic and diluted net loss per share | 247,970 | 212,943 | 35,027 | (16 | %) |
____________________
* Not meaningful
(1) There is no provision for income taxes associated with the non-cash loss on extinguishment of debt as a result of our full valuation allowance.
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 www.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 headquartered in Westlake Village, Calif., and has a manufacturing and R&D facility in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S. Please visit www.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 potential approval and commercial launch of Tyvaso DPI, MannKind’s future commercial growth and pipeline advancement, and MannKind’s ability to directly 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, the risk that Tyvaso DPI may not be approved by the FDA on the timeline expected, or at all, 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, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K, each as filed with the Securities and Exchange Commission. 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.
Thyquidity is a trademark of Vertice Pharma.
Company Contact:
818-661-5000
ir@mannkindcorp.com
MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share and per share data)
June 30, 2021 | December 31, 2020 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 62,522 | $ | 67,005 | |||
Restricted cash | — | 158 | |||||
Short-term investments | 99,970 | — | |||||
Accounts receivable, net | 6,305 | 4,218 | |||||
Inventory | 7,482 | 4,973 | |||||
Prepaid expenses and other current assets | 3,624 | 3,122 | |||||
Total current assets | 179,903 | 79,476 | |||||
Property and equipment, net | 28,139 | 25,867 | |||||
Long-term investments | 38,950 | — | |||||
Other assets | 5,799 | 3,265 | |||||
Total assets | $ | 252,791 | $ | 108,608 | |||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 7,486 | $ | 5,582 | |||
Accrued expenses and other current liabilities | 22,406 | 19,707 | |||||
PPP loan — current | 4,873 | 4,061 | |||||
Deferred revenue — current | 20,126 | 33,275 | |||||
Recognized loss on purchase commitments — current | 5,538 | 11,080 | |||||
Total current liabilities | 60,429 | 73,705 | |||||
Senior convertible notes | 223,217 | — | |||||
MidCap credit facility | 38,614 | 49,335 | |||||
Mann Group promissory notes | 18,425 | 63,027 | |||||
Accrued interest — Mann Group promissory notes | 169 | 4,150 | |||||
PPP loan — long term | — | 812 | |||||
2024 convertible notes | — | 5,000 | |||||
Recognized loss on purchase commitments — long term | 83,179 | 84,208 | |||||
Operating lease liability | 564 | 1,202 | |||||
Deferred revenue — long term | 1,589 | 1,662 | |||||
Milestone rights liability | 4,839 | 5,926 | |||||
Deposits from customer | 5,317 | — | |||||
Total liabilities | 436,342 | 289,027 | |||||
Stockholders' deficit: | |||||||
Undesignated preferred stock, no shares issued or outstanding as of June 30, 2021 and December 31, 2020 | — | — | |||||
Common stock, authorized, 249,617,550 and 242,117,089 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 2,496 | 2,421 | |||||
Additional paid-in capital | 2,911,535 | 2,866,303 | |||||
Accumulated deficit | (3,097,582 | ) | (3,049,143 | ) | |||
Total stockholders' deficit | (183,551 | ) | (180,419 | ) | |||
Total liabilities and stockholders' deficit | $ | 252,791 | $ | 108,608 |
MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenues: | |||||||||||||||
Net revenue — commercial product sales | $ | 9,976 | $ | 6,985 | $ | 18,075 | $ | 14,985 | |||||||
Revenue — collaborations and services | 13,304 | 8,129 | 22,641 | 16,364 | |||||||||||
Total revenues | 23,280 | 15,114 | 40,716 | 31,349 | |||||||||||
Expenses: | |||||||||||||||
Cost of goods sold | 4,411 | 3,677 | 8,726 | 7,841 | |||||||||||
Cost of revenue — collaborations and services | 5,515 | 1,983 | 8,810 | 5,345 | |||||||||||
Research and development | 2,329 | 1,464 | 4,771 | 3,219 | |||||||||||
Selling, general and administrative | 20,056 | 13,670 | 37,469 | 28,020 | |||||||||||
Asset impairment | — | 368 | — | 1,889 | |||||||||||
Loss (gain) on foreign currency translation | 903 | 1,867 | (2,935 | ) | 71 | ||||||||||
Loss on purchase commitments | 339 | — | 339 | — | |||||||||||
Total expenses | 33,553 | 23,029 | 57,180 | 46,385 | |||||||||||
Loss from operations | (10,273 | ) | (7,915 | ) | (16,464 | ) | (15,036 | ) | |||||||
Other (expense) income: | |||||||||||||||
Interest income | 25 | 14 | 28 | 147 | |||||||||||
Interest expense on notes | (2,812 | ) | (1,084 | ) | (8,234 | ) | (2,155 | ) | |||||||
Interest expense on Mann Group promissory notes | (368 | ) | (1,281 | ) | (1,398 | ) | (2,540 | ) | |||||||
Loss on extinguishment of debt | (22,130 | ) | — | (22,130 | ) | — | |||||||||
Other income (expense) | 35 | 14 | (241 | ) | 10 | ||||||||||
Total other expense | (25,250 | ) | (2,337 | ) | (31,975 | ) | (4,538 | ) | |||||||
Loss before provision for income taxes | (35,523 | ) | (10,252 | ) | (48,439 | ) | (19,574 | ) | |||||||
Provision for income taxes | — | — | — | — | |||||||||||
Net loss | $ | (35,523 | ) | $ | (10,252 | ) | $ | (48,439 | ) | $ | (19,574 | ) | |||
Net loss per share - basic and diluted | $ | (0.14 | ) | $ | (0.05 | ) | $ | (0.20 | ) | $ | (0.09 | ) | |||
Shares used to compute basic and diluted net loss per share | 249,295 | 213,880 | 247,970 | 212,943 |
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