MannKind Corporation Reports 2024 First Quarter Financial Results: Provides Clinical Development Update
- 1Q 2024 Total revenues of
$66M ; +63% vs. 1Q 2023 - 1Q 2024 Net income of
$11M ; Non-GAAP net income of$15M $304M of cash and cash equivalents and investments atMarch 31, 2024 - In early April, repaid Midcap senior-secured debt and
Mann Group convertible debt totaling approximately$37M - FDA Fast Track designation and IND clearance received for MNKD-101
“We achieved our eighth consecutive quarter of revenue growth putting us on a run rate of over
Revenue Highlights
| Three Months Ended |
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| 2024 | 2023 | $ Change | % Change | |||||||||||||
| (Dollars in thousands) | ||||||||||||||||
| Royalties – collaborations | $ | 22,651 | $ | 11,678 | $ | 10,973 | 94 | % | ||||||||
| Revenue – collaborations and services | 24,848 | 11,386 | $ | 13,462 | 118 | % | ||||||||||
| Net revenue – Afrezza | 14,438 | 12,423 | $ | 2,015 | 16 | % | ||||||||||
| Net revenue – V-Go | 4,326 | 5,139 | $ | (813 | ) | (16 | %) | |||||||||
| Total revenues | $ | 66,263 | $ | 40,626 | $ | 25,637 | 63 | % | ||||||||
Royalties related to Tyvaso DPI for the first quarter of 2024 increased
Commercial product gross margin in the first quarter of 2024 was 80% compared to 69% for the same period in 2023. The increase in gross margin was primarily attributable to an increase in Afrezza net revenue.
Cost of revenue – collaborations and services for the first quarter of 2024 was
Research and development ("R&D") expenses for the first quarter of 2024 were
Selling expenses were
General and administrative expenses for the first quarter of 2024 were
Interest income, net, was
Interest expense on notes was
Interest expense on liability for sale of future royalties was
Cash, cash equivalents and investments as of
Non-GAAP Measures
To supplement our condensed 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 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 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 net income (loss) and net income (loss) per share ("EPS") for diluted weighted average shares as reported in our condensed consolidated statements 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 and (gain) loss on foreign currency transaction for the periods presented:
| Three Months | |||||||||||||||
| Ended |
|||||||||||||||
| 2024 | 2023 | ||||||||||||||
| Net Income |
Diluted EPS |
Net Loss | Diluted EPS |
||||||||||||
| (In thousands except per share data) | |||||||||||||||
| GAAP reported | $ | 10,630 | $ | 0.04 | $ | (9,795 | ) | $ | (0.04 | ) | |||||
| Select non-cash adjustments: | |||||||||||||||
| Sold portion of royalty revenue (1) | (2,265 | ) | (0.01 | ) | — | — | |||||||||
| Interest expense on liability for sale of future royalties | 4,248 | 0.01 | — | — | |||||||||||
| Stock compensation | 3,885 | 0.01 | 3,655 | 0.01 | |||||||||||
| (Gain) loss on foreign currency transaction | (1,399 | ) | — | 954 | 0.01 | ||||||||||
| Non-GAAP adjusted | $ | 15,099 | $ | 0.05 | $ | (5,186 | ) | $ | (0.02 | ) | |||||
| Weighted average shares used to compute net income (loss) per share – diluted | 324,733 | 263,969 | |||||||||||||
__________________________
(1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during 1Q 2024 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 1Q 2024 totaled
Clinical Development Update
Afrezza INHALE-1 (pediatric phase 3 clinical trial)
- Patient enrollment and randomization completed in 1Q 2024
- Upcoming expected data read-outs and planned
U.S. Food and Drug Administration ("FDA") submission:- Primary endpoint analysis in 4Q 2024
- Full results in 1H 2025
- FDA submission for label expansion in 2025
Afrezza INHALE-3 (T1DM, Afrezza vs. standard of care including AID pumps; phase 4 clinical trial)
- Last participant completed randomized treatment phase in 1Q 2024
- First meal dosing presented at ATTD conference in
March 2024 - Upcoming expected data read-outs:
- Randomized treatment phase top-line data/primary endpoints to be presented at
ADA conference inJune 2024 - Additional data to be presented at ADCES August conference
- Randomized treatment phase top-line data/primary endpoints to be presented at
MNKD-101 (clofazimine inhalation suspension)
- Fast Track designation received from the FDA
- FDA clearance of Investigational New Drug Application ("IND")
- Co-primary endpoints of sputum conversion and patient-reported outcomes
- Up to 120 global sites, first patient expected to enroll in 2Q 2024
MNKD-201 (nintedanib DPI)
- FDA clearance to proceed to Phase 1 clinical trial
- 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, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. 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, depending on the target indication.
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, X 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 expected timing of patient enrollment and dosing in clinical studies of MNKD-101 and MNKD-201; the potential for expedited review of a regulatory submission for MNKD-101 and the potential to bring MNKD-101 to patients more quickly; expected timing for data read-outs for clinical studies of MNKD-201 and Afrezza; and the timing of planned FDA submissions for Afrezza. 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, risks and uncertainties related to unforeseen delays that may impact the timing of progressing clinical trials and reporting data, risks associated with safety and other complications of our products and product candidates; risks associated with the regulatory review process; 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 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
| Three Months Ended |
||||||||
| 2024 | 2023 | |||||||
| (In thousands except per share data) | ||||||||
| Revenues: | ||||||||
| Net revenue – commercial product sales | $ | 18,764 | $ | 17,562 | ||||
| Revenue – collaborations and services | 24,848 | 11,386 | ||||||
| Royalties – collaborations | 22,651 | 11,678 | ||||||
| Total revenues | 66,263 | 40,626 | ||||||
| Expenses: | ||||||||
| Cost of goods sold | 3,819 | 5,530 | ||||||
| Cost of revenue – collaborations and services | 14,779 | 10,683 | ||||||
| Research and development | 10,013 | 5,605 | ||||||
| Selling | 11,601 | 13,310 | ||||||
| General and administrative | 10,728 | 10,542 | ||||||
| (Gain) loss on foreign currency transaction | (1,399 | ) | 954 | |||||
| Total expenses | 49,541 | 46,624 | ||||||
| Income (loss) from operations | 16,722 | (5,998 | ) | |||||
| Other income (expense): | ||||||||
| Interest income, net | 3,434 | 1,302 | ||||||
| Interest expense on financing liability | (2,447 | ) | (2,424 | ) | ||||
| Interest expense | (2,567 | ) | (2,786 | ) | ||||
| Interest expense on liability for sale of future royalties | (4,248 | ) | — | |||||
| Other income | — | 111 | ||||||
| Total other expense | (5,828 | ) | (3,797 | ) | ||||
| Income (loss) before income tax expense | 10,894 | (9,795 | ) | |||||
| Income tax expense | 264 | — | ||||||
| Net income (loss) | $ | 10,630 | $ | (9,795 | ) | |||
| Net income (loss) per share – basic | $ | 0.04 | $ | (0.04 | ) | |||
| Weighted average shares used to compute net income (loss) per share – basic |
270,356 | 263,969 | ||||||
| Net income (loss) per share – diluted | $ | 0.04 | (1) | $ | (0.04 | ) | ||
| Weighted average shares used to compute net income (loss) per share – diluted |
324,733 | (2) | 263,969 | |||||
__________________________
(1) The calculation of diluted EPS includes an add back of interest expense to net income which represents interest that would not be recognized if the conversion of our Senior convertible notes and
(2) 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 CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
| (In thousands except share and per share data) |
||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 193,272 | $ | 238,480 | ||||
| Short-term investments | 107,457 | 56,619 | ||||||
| Accounts receivable, net | 19,912 | 14,901 | ||||||
| Inventory | 26,442 | 28,545 | ||||||
| Prepaid expenses and other current assets | 36,019 | 34,848 | ||||||
| Total current assets | 383,102 | 373,393 | ||||||
| Property and equipment, net | 83,620 | 84,220 | ||||||
| 1,931 | 1,931 | |||||||
| Other intangible asset | 1,053 | 1,073 | ||||||
| Long-term investments | 3,726 | 7,155 | ||||||
| Other assets | 7,447 | 7,426 | ||||||
| Total assets | $ | 480,879 | $ | 475,198 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,149 | $ | 9,580 | ||||
| Accrued expenses and other current liabilities | 42,291 | 42,036 | ||||||
| Financing liability – current | 9,872 | 9,809 | ||||||
| Midcap credit facility – current | 20,000 | — | ||||||
| Liability for sale of future royalties – current | 10,537 | 9,756 | ||||||
| Deferred revenue – current | 7,601 | 9,085 | ||||||
| Recognized loss on purchase commitments – current | 2,446 | 3,859 | ||||||
| Total current liabilities | 99,896 | 104,125 | ||||||
| 8,829 | 8,829 | |||||||
| Accrued interest – |
55 | 56 | ||||||
| Financing liability – long term | 94,207 | 94,319 | ||||||
| Midcap credit facility – long term | 8,105 | 13,019 | ||||||
| Senior convertible notes | 227,214 | 226,851 | ||||||
| Liability for sale of future royalties – long term | 137,418 | 136,054 | ||||||
| Recognized loss on purchase commitments – long term | 60,287 | 60,942 | ||||||
| Operating lease liability | 3,645 | 3,925 | ||||||
| Deferred revenue – long term | 67,741 | 69,794 | ||||||
| Milestone liabilities | 3,452 | 3,452 | ||||||
| Total liabilities | 710,849 | 721,366 | ||||||
| Stockholders' deficit: | ||||||||
| Undesignated preferred stock, no shares issued or outstanding as of |
— | — | ||||||
| Common stock, 270,801,781 and 270,034,495 shares issued and outstanding as of |
2,703 | 2,700 | ||||||
| Additional paid-in capital | 2,986,104 | 2,980,539 | ||||||
| Accumulated deficit | (3,218,777 | ) | (3,229,407 | ) | ||||
| Total stockholders' deficit | (229,970 | ) | (246,168 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 480,879 | $ | 475,198 | ||||
Source: MannKind