MannKind Corporation Reports 2023 Fourth Quarter and Full Year Financial Results: Provides Clinical Development Update
- 2023 Total revenues of
$199M ; +99% vs. 2022 - 4Q 2023 Total revenues of
$58M ; +62% vs. 2022 - 4Q 2023 Net income of
$1M ; Non-GAAP net income of$7M $302M of cash and cash equivalents and investments atDecember 31, 2023
“We doubled our total revenues to nearly
Fourth Quarter 2023 Results
Revenue Highlights
Three Months Ended |
||||||||||||||||
2023 | 2022 | $ Change | % Change | |||||||||||||
(Dollars in thousands) | ||||||||||||||||
Net revenue – Afrezza | $ | 15,487 | $ | 12,006 | $ | 3,481 | 29 | % | ||||||||
Net revenue – V-Go | 4,708 | 5,434 | $ | (726 | ) | (13 | %) | |||||||||
Revenue – collaborations and services | 17,249 | 9,544 | $ | 7,705 | 81 | % | ||||||||||
Royalties – collaborations | 21,028 | 9,075 | $ | 11,953 | 132 | % | ||||||||||
Total revenues | $ | 58,472 | $ | 36,059 | $ | 22,413 | 62 | % | ||||||||
Afrezza® net revenue for the fourth quarter of 2023 increased
Commercial product gross margin in the fourth quarter of 2023 was 70% compared to 77% for the same period in 2022. The decrease in gross margin was primarily attributable to an increase in cost of goods sold for Afrezza due to the timing of the capitalization of costs to inventory and lower net revenue for V-Go.
Cost of revenue – collaborations and services was
Research and development ("R&D") expenses for the fourth quarter of 2023 were
Selling expenses were
General and administrative expenses for the fourth quarter of 2023 were
Interest income was
Interest expense on notes was
Loss on available-for-sale securities for the fourth quarter of 2023 was
Year Ended
Revenue Highlights
Year Ended |
||||||||||||||||
2023 | 2022 | $ Change | % Change | |||||||||||||
(Dollars in thousands) | ||||||||||||||||
Net revenue – Afrezza | $ | 54,914 | $ | 43,316 | $ | 11,598 | 27 | % | ||||||||
Net revenue – V-Go | 19,115 | 12,931 | $ | 6,184 | 48 | % | ||||||||||
Revenue – collaborations and services | 52,954 | 27,924 | $ | 25,030 | 90 | % | ||||||||||
Royalties – collaborations | 71,979 | 15,599 | $ | 56,380 | * | |||||||||||
Total revenues | $ | 198,962 | $ | 99,770 | $ | 99,192 | 99 | % |
________________________
* Not meaningful
Afrezza net revenue for the year ended
Commercial product gross margin was 72% for the year ended
Cost of revenue – collaborations and services for the year ended
R&D expenses for the year ended
Selling expenses for the year ended
General and administrative expenses for the year ended
Interest income was
Interest expense on notes and milestone rights was
Loss on available-for-sale securities for the year ended
Cash, cash equivalents and investments as of
Non-GAAP Measures
To supplement our consolidated financial statements presented under
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 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 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 financial measure for income (loss) from operations, net income (loss) and net income (loss) per share ("EPS") for basic and diluted weighted average shares as reported in our consolidated statement of operations to a non-GAAP presentation as adjusted for select non-cash items: 1% royalty on net revenues for Tyvaso DPI ("Sold portion of royalty revenue") and interest expense on the related liability, stock-based compensation expense, gain on foreign currency transaction and gain on available-for-sale securities for the periods presented (in thousands, except per share amounts):
Three Months | Year | |||||||||||
Ended |
Ended |
|||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||
(In thousands except per share data) | ||||||||||||
GAAP income (loss) from operations | $ | 7,858 | $ | (12,790 | ) | $ | 8,678 | $ | (64,110 | ) | ||
Select non-cash adjustments: | ||||||||||||
Sold portion of royalty revenue (1) | (2,103 | ) | — | (2,103 | ) | — | ||||||
Stock compensation | 3,786 | 2,597 | 17,649 | 13,447 | ||||||||
Loss (gain) on foreign currency transaction | 2,776 | 3,474 | 1,916 | (4,811 | ) | |||||||
Non-GAAP income (loss) from operations | $ | 12,317 | $ | (6,719 | ) | $ | 26,140 | $ | (55,474 | ) | ||
GAAP net income (loss) | $ | 1,401 | $ | (17,947 | ) | $ | (11,938 | ) | $ | (87,400 | ) | |
Select non-cash adjustments: | ||||||||||||
Sold portion of royalty revenue (1) | (2,103 | ) | — | (2,103 | ) | — | ||||||
Stock compensation | 3,786 | 2,597 | 17,649 | 13,447 | ||||||||
Loss (gain) on foreign currency transaction | 2,776 | 3,474 | 1,916 | (4,811 | ) | |||||||
Interest expense on liability for sale of future royalties | 185 | — | 185 | — | ||||||||
Loss on available-for-sale securities | 1,102 | 932 | 170 | 932 | ||||||||
Non-GAAP net income (loss) | $ | 7,147 | $ | (10,944 | ) | $ | 5,879 | $ | (77,832 | ) | ||
GAAP net income (loss) per share - basic | $ | 0.01 | $ | (0.07 | ) | $ | (0.04 | ) | $ | (0.34 | ) | |
Select non-cash adjustments: | ||||||||||||
Sold portion of royalty revenue | (0.01 | ) | 0.00 | (0.01 | ) | 0.00 | ||||||
Stock compensation | 0.01 | 0.01 | 0.07 | 0.05 | ||||||||
Loss (gain) on foreign currency transaction | 0.01 | 0.01 | 0.01 | (0.02 | ) | |||||||
Interest expense on liability for sale of future royalties | 0.00 | 0.00 | 0.00 | 0.00 | ||||||||
Loss on available-for-sale securities | 0.00 | 0.00 | 0.00 | 0.00 | ||||||||
Non-GAAP net income (loss) per share - basic | $ | 0.02 | $ | (0.05 | ) | $ | 0.03 | $ | (0.31 | ) | ||
Weighted average shares - basic | 269,648 | 263,378 | 267,014 | 257,092 |
__________________________
(1) | Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during 4Q 2023 which is remitted to the royalty purchaser and recognized as royalties from collaborations in our consolidated statements of operations. Our revenues from royalties from collaborations during 4Q 2023 totaled |
Clinical Development Update
Afrezza INHALE-1 (pediatric phase 3 clinical trial)
- Enrollment completed in
February 2024 - Upcoming expected data read-outs:
- Primary endpoint analysis in 4Q 2024
- Full results in 1H 2025
- FDA submission for label expansion expected in 2025
Afrezza INHALE-3 (T1DM, Afrezza vs. standard of care including AID pumps; phase 4 clinical trial)
- Enrollment completed ahead of schedule in 4Q 2023
- Upcoming expected data read-outs:
- First meal dosing – ATTD oral presentation in
March 2024 - 17-week top-line data/primary endpoints to be presented at
ADA inJune 2024 - Additional data to be presented at ADCES August conference
- First meal dosing – ATTD oral presentation in
MNKD-101 (clofazimine inhalation suspension)
- Phase 3 development program aligned with the FDA – IND expected to be filed in 1Q 2024
- Co-primary endpoints of sputum conversion and patient-reported outcomes
- Up to 100 global sites, first patient expected to enroll in 2Q 2024
MNKD-201 (nintedanib DPI)
- Phase 1 development program in healthy volunteers, expected to dose first patient in 2Q 2024
- Results expected in late 2024
Conference Call
About
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 the commencement of clinical studies of MNKD-101 and MNKD-201, FDA submissions and the data read-outs from clinical studies of Afrezza and MNKD-201. 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 various risks and uncertainties, which include, without limitation, risks associated with manufacturing and supply, risks associated with developing product candidates, and other risks detailed in MannKind’s filings with the
Tyvaso DPI is a trademark of United Therapeutics Corporation.
AFREZZA,
MannKind Contact:
(818) 661-5000
IR@mannkindcorp.com
MANNKIND CORPORATION AND SUBSIDIARY | ||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
Three Months Ended |
Year Ended |
|||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
(In thousands except per share data) | ||||||||||||||||
Revenues: | ||||||||||||||||
Net revenue – commercial product sales | $ | 20,195 | $ | 17,440 | $ | 74,029 | $ | 56,247 | ||||||||
Revenue – collaborations and services | 17,249 | 9,544 | 52,954 | 27,924 | ||||||||||||
Royalties – collaborations | 21,028 | 9,075 | 71,979 | 15,599 | ||||||||||||
Total revenues | 58,472 | 36,059 | 198,962 | 99,770 | ||||||||||||
Expenses: | ||||||||||||||||
Cost of goods sold | 6,114 | 4,081 | 20,863 | 16,003 | ||||||||||||
Cost of revenue – collaborations and services | 11,953 | 12,043 | 41,908 | 41,494 | ||||||||||||
Research and development | 9,236 | 7,156 | 31,283 | 19,721 | ||||||||||||
Selling | 11,024 | 11,616 | 51,776 | 53,753 | ||||||||||||
General and administrative | 9,511 | 10,479 | 42,538 | 37,720 | ||||||||||||
Loss (gain) on foreign currency transaction | 2,776 | 3,474 | 1,916 | (4,811 | ) | |||||||||||
Total expenses | 50,614 | 48,849 | 190,284 | 163,880 | ||||||||||||
Income (loss) from operations | 7,858 | (12,790 | ) | 8,678 | (64,110 | ) | ||||||||||
Other income (expense): | ||||||||||||||||
Interest income, net | 1,725 | 957 | 6,154 | 2,513 | ||||||||||||
Interest expense on financing liability | (2,493 | ) | (2,478 | ) | (9,825 | ) | (9,758 | ) | ||||||||
Interest expense | (2,677 | ) | (2,809 | ) | (15,151 | ) | (15,011 | ) | ||||||||
Interest expense on liability for sale of future royalties | (185 | ) | — | (185 | ) | — | ||||||||||
Loss on available-for-sale securities | (1,102 | ) | (932 | ) | (170 | ) | (932 | ) | ||||||||
Other income (expense) | (164 | ) | 105 | 122 | (102 | ) | ||||||||||
Total other expense | (4,896 | ) | (5,157 | ) | (19,055 | ) | (23,290 | ) | ||||||||
Income (loss) before income tax expense | 2,962 | (17,947 | ) | (10,377 | ) | (87,400 | ) | |||||||||
Income tax expense | (1,561 | ) | — | (1,561 | ) | — | ||||||||||
Net income (loss) | $ | 1,401 | $ | (17,947 | ) | $ | (11,938 | ) | $ | (87,400 | ) | |||||
Net income (loss) per share – basic | $ | 0.01 | $ | (0.07 | ) | $ | (0.04 | ) | $ | (0.34 | ) | |||||
Weighted average shares used to compute net income (loss) per share – basic |
269,648 | 263,378 | 267,014 | 257,092 | ||||||||||||
Net income (loss) per share – diluted | $ | 0.00 | $ | (0.07 | ) | $ | (0.04 | ) | $ | (0.34 | ) | |||||
Weighted average shares used to compute net income (loss) per share – diluted |
323,880 | (1) | 263,378 | 267,014 | 257,092 |
__________________________
(1) | Diluted weighted average shares differs from basic due to the weighted average number of shares that would be outstanding upon conversion of our Senior convertible notes (44,120 shares) and |
MANNKIND CORPORATION AND SUBSIDIARY | ||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||
|
||||||||
(In thousands except share and per share data) |
||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 238,480 | $ | 69,767 | ||||
Short-term investments | 56,619 | 101,079 | ||||||
Accounts receivable, net | 14,901 | 16,801 | ||||||
Inventory | 28,545 | 21,772 | ||||||
Prepaid expenses and other current assets | 34,848 | 25,477 | ||||||
Total current assets | 373,393 | 234,896 | ||||||
Property and equipment, net | 84,220 | 45,126 | ||||||
1,931 | 2,428 | |||||||
Other intangible asset | 1,073 | 1,153 | ||||||
Long-term investments | 7,155 | 1,961 | ||||||
Other assets | 7,426 | 9,718 | ||||||
Total assets | $ | 475,198 | $ | 295,282 | ||||
LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 9,580 | $ | 11,052 | ||||
Accrued expenses and other current liabilities | 42,036 | 35,553 | ||||||
Financing liability – current | 9,809 | 9,565 | ||||||
Midcap credit facility – current | 20,000 | — | ||||||
Liability for sale of future royalties – current | 9,756 | — | ||||||
Deferred revenue – current | 9,085 | 1,733 | ||||||
Recognized loss on purchase commitments – current | 3,859 | 9,393 | ||||||
Total current liabilities | 104,125 | 67,296 | ||||||
8,829 | 8,829 | |||||||
Accrued interest – |
56 | 55 | ||||||
Financing liability – long term | 94,319 | 94,512 | ||||||
Midcap credit facility – long term | 13,019 | 39,264 | ||||||
Senior convertible notes | 226,851 | 225,397 | ||||||
Liability for sale of future royalties – long term | 136,054 | — | ||||||
Recognized loss on purchase commitments – long term | 60,942 | 62,916 | ||||||
Operating lease liability | 3,925 | 5,343 | ||||||
Deferred revenue – long term | 69,794 | 37,684 | ||||||
Milestone liabilities | 3,452 | 4,524 | ||||||
Total liabilities | 721,366 | 545,820 | ||||||
Stockholders' deficit: | ||||||||
Undesignated preferred stock, no shares issued or outstanding as of |
— | — | ||||||
Common stock, authorized as of and 270,034,495 and 263,793,305 shares issued and outstanding as of |
2,700 | 2,638 | ||||||
Additional paid-in capital | 2,980,539 | 2,964,293 | ||||||
Accumulated other comprehensive income | — | — | ||||||
Accumulated deficit | (3,229,407 | ) | (3,217,469 | ) | ||||
Total stockholders' deficit | (246,168 | ) | (250,538 | ) | ||||
Total liabilities and stockholders' deficit | $ | 475,198 | $ | 295,282 |
![](https://ml.globenewswire.com/media/NzgyZTc2MTAtODQ2Ny00MGVmLTlhZjktYTAyMjFjMWRhMDY2LTEwMTk2ODA=/tiny/MannKind.png)
Source: MannKind