MannKind Corporation Reports 2020 Third Quarter Financial Results
Conference Call to Begin Today at
- 3Q 2020 U.S. Afrezza Net Revenue of
$7.3 million ; +27% vs. 3Q 2019 - 3Q YTD 2020 U.S. Afrezza Net Revenue of
$22.1 million ; +31% vs. 3Q YTD 2019 - Cash and cash equivalents of
$52.4 million atSeptember 30, 2020 - On track to complete Treprostinil Technosphere development activities in 4Q 2020
- Expanded Afrezza commercial and medical teams
- YTD Afrezza scientific presentations and publications total 14
“Our employees continue to execute in a tumultuous Covid-19 environment,” said
Third Quarter 2020 Results
Total revenues were
Afrezza gross profit for the third quarter of 2020 was
Selling, general and administrative expenses for the third quarter of 2020 were
Interest expense for the third quarter of 2020 was
A loss on foreign currency translation for the third quarter of 2020 was
The net loss for the third quarter of 2020 was
Nine Months Ended September 30, 2020
Total revenues were
Afrezza gross profit for the nine months ended
Selling, general and administrative expenses for the nine months ended
The loss on foreign currency translation for the nine months ended
The net loss for the nine months ended
Cash, cash equivalents and restricted cash at
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 prepared in accordance with GAAP.
| Three Months Ended |
||||||||||||||||
| 2020 | 2019 | $ Change |
% Change |
|||||||||||||
| Net revenue — Afrezza | $ | 7,275 | $ | 6,402 | $ | 873 | 14 | % | ||||||||
| Less cost of goods sold | (3,591 | ) | (7,099 | ) | $ | (3,508 | ) | (49 | %) | |||||||
| GAAP gross profit (loss) — Afrezza | 3,684 | (697 | ) | $ | 4,381 | * | ||||||||||
| Exclude Amphastar amendment fee | — | 2,750 | $ | (2,750 | ) | (100 | %) | |||||||||
| Non-GAAP gross profit — Afrezza | $ | 3,684 | $ | 2,053 | $ | 1,631 | 79 | % | ||||||||
| Non-GAAP gross margin | 51 | % | 32 | % | ||||||||||||
* Not meaningful
| Nine Months Ended |
||||||||||||||||
| 2020 | 2019 | $ Change |
% Change |
|||||||||||||
| Net revenue — Afrezza | $ | 22,260 | $ | 17,543 | $ | 4,717 | 27 | % | ||||||||
| Less cost of goods sold | (11,432 | ) | (15,446 | ) | $ | (4,014 | ) | (26 | %) | |||||||
| GAAP gross profit — Afrezza | 10,828 | 2,097 | $ | 8,731 | 416 | % | ||||||||||
| Exclude Amphastar amendment fee | — | 2,750 | $ | (2,750 | ) | (100 | %) | |||||||||
| Non-GAAP gross profit — Afrezza | $ | 10,828 | $ | 4,847 | $ | 5,981 | 123 | % | ||||||||
| Non-GAAP gross margin | 49 | % | 28 | % | ||||||||||||
| Nine Months Ended |
||||||||||||||||
| 2020 | 2019 | $ Change |
% Change |
|||||||||||||
| Net cash used in operating activities | $ | (28,363 | ) | $ | (83,376 | ) | $ | 55,013 | 66 | % | ||||||
| Exclude UT payment received | (12,500 | ) | (12,500 | ) | $ | — | — | % | ||||||||
| Exclude payment-in-kind interest on promissory notes | — | (32,822 | ) | $ | 32,822 | 100 | % | |||||||||
| Non-GAAP cash used in operating activities | $ | (40,863 | ) | $ | (128,698 | ) | $ | 87,835 | 68 | % | ||||||
Conference Call
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About
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "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 various risks and uncertainties detailed in MannKind's filings with the SEC, including risks related to the COVID-19 pandemic. For a discussion of these and other factors, please refer to MannKind’s annual report on Form 10-K for the year ended December 31, 2019 as well as MannKind’s other filings with the SEC. 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.
Company Contact:
818-661-5000
ir@mannkindcorp.com
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except per share data)
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 52,398 | $ | 29,906 | ||||
| Restricted cash | 316 | 316 | ||||||
| Short-term investments | — | 19,978 | ||||||
| Accounts receivable, net | 4,135 | 3,513 | ||||||
| Inventory | 4,881 | 4,155 | ||||||
| Prepaid expenses and other current assets | 4,616 | 2,889 | ||||||
| Total current assets | 66,346 | 60,757 | ||||||
| Property and equipment, net | 25,736 | 26,778 | ||||||
| Other assets | 3,599 | 6,190 | ||||||
| Total assets | $ | 95,681 | $ | 93,725 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,797 | $ | 4,789 | ||||
| Accrued expenses and other current liabilities | 15,814 | 15,904 | ||||||
| Short-term notes payable | 45,379 | 5,028 | ||||||
| Deferred revenue — current | 28,867 | 32,503 | ||||||
| Recognized loss on purchase commitments — current | 10,267 | 7,394 | ||||||
| Total current liabilities | 106,124 | 65,618 | ||||||
| Promissory notes | 70,025 | 70,020 | ||||||
| Accrued interest — promissory notes | 5,854 | 2,002 | ||||||
| Long-term Midcap credit facility | — | 38,851 | ||||||
| Senior convertible notes | 5,000 | 5,000 | ||||||
| Paycheck Protection Program loan — long term | 1,421 | — | ||||||
| Recognized loss on purchase commitments — long term | 84,529 | 84,639 | ||||||
| Operating lease liability | 1,523 | 2,514 | ||||||
| Deferred revenue — long term | 1,699 | 8,344 | ||||||
| Milestone rights liability | 5,926 | 7,263 | ||||||
| Total liabilities | 282,101 | 284,251 | ||||||
| Stockholders' deficit: | ||||||||
| Undesignated preferred stock, $ par value — shares authorized; shares issued or outstanding as of |
— | — | ||||||
| Common stock, $ par value - 400,000,000 and 280,000,000 shares authorized, 230,922,513 and 211,787,573 shares issued and outstanding at |
2,309 | 2,118 | ||||||
| Additional paid-in capital | 2,834,003 | 2,799,278 | ||||||
| Accumulated other comprehensive loss | — | (19 | ) | |||||
| Accumulated deficit | (3,022,732 | ) | (2,991,903 | ) | ||||
| Total stockholders' deficit | (186,420 | ) | (190,526 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 95,681 | $ | 93,725 | ||||
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
| Three Months Ended |
Nine Months Ended |
||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Revenues: | |||||||||||||||
| Net revenue — commercial product sales | $ | 7,275 | $ | 6,402 | $ | 22,260 | $ | 17,543 | |||||||
| Revenue — collaborations and services | 8,077 | 8,193 | 24,441 | 29,502 | |||||||||||
| Total revenues | 15,352 | 14,595 | 46,701 | 47,045 | |||||||||||
| Expenses: | |||||||||||||||
| Cost of goods sold | 3,591 | 7,099 | 11,432 | 15,446 | |||||||||||
| Cost of revenue — collaborations and services | 1,581 | 1,836 | 6,926 | 5,512 | |||||||||||
| Research and development | 1,484 | 1,580 | 4,703 | 4,879 | |||||||||||
| Selling, general and administrative | 13,899 | 16,666 | 41,919 | 58,948 | |||||||||||
| Asset impairment | — | — | 1,889 | — | |||||||||||
| Loss (gain) on foreign currency translation | 3,927 | (3,807 | ) | 3,998 | (4,495 | ) | |||||||||
| Total expenses | 24,482 | 23,374 | 70,867 | 80,290 | |||||||||||
| Loss from operations | (9,130 | ) | (8,779 | ) | (24,166 | ) | (33,245 | ) | |||||||
| Other (expense) income: | |||||||||||||||
| Interest income | 18 | 220 | 165 | 794 | |||||||||||
| Interest expense on notes | (1,057 | ) | (4,126 | ) | (3,212 | ) | (5,283 | ) | |||||||
| Interest expense on promissory notes | (1,318 | ) | (1,162 | ) | (3,858 | ) | (3,351 | ) | |||||||
| Gain on extinguishment of debt | — | 3,529 | — | 3,529 | |||||||||||
| Other income (expense) | 14 | (52 | ) | 24 | (84 | ) | |||||||||
| Total other expense | (2,343 | ) | (1,591 | ) | (6,881 | ) | (4,395 | ) | |||||||
| Loss before provision for income taxes | (11,473 | ) | (10,370 | ) | (31,047 | ) | (37,640 | ) | |||||||
| Benefit for income taxes | 218 | — | 218 | — | |||||||||||
| Net loss | $ | (11,255 | ) | $ | (10,370 | ) | $ | (30,829 | ) | $ | (37,640 | ) | |||
| Net loss per share - basic and diluted | $ | (0.05 | ) | $ | (0.05 | ) | $ | (0.14 | ) | $ | (0.20 | ) | |||
| Shares used to compute basic and diluted net loss per share | 229,668 | 199,906 | 218,559 | 191,786 | |||||||||||
Source: MannKind