MannKind Corporation Reports 2024 Second Quarter Financial Results: Provides Clinical Development Update
Rhea-AI Summary
MannKind (MNKD) reported strong financial results for Q2 2024, with total revenues of $72M, up 49% year-over-year. The company achieved its ninth consecutive quarter of revenue growth, approaching an annual revenue run rate of over $275 million. Key highlights include:
- Royalties from Tyvaso DPI increased 34% to $25.6M
- Collaborations and services revenue up 132% to $26M
- Afrezza net revenue grew 20% to $16.3M
- YTD 2024 net income of $9M; Non-GAAP net income of $29M
MannKind also made progress on its clinical pipeline, initiating Phase 3 trials for MNKD-101 and Phase 1 trials for MNKD-201. The company remains focused on its diversification strategy, allocating capital towards pipeline development, in-line growth, and debt reduction.
Positive
- Total revenues increased 49% year-over-year to $72M in Q2 2024
- Achieved ninth consecutive quarter of revenue growth
- Approaching annual revenue run rate of over $275 million
- Royalties from Tyvaso DPI increased 34% to $25.6M
- Collaborations and services revenue up 132% to $26M
- Afrezza net revenue grew 20% to $16.3M
- YTD 2024 net income of $9M; Non-GAAP net income of $29M
- Initiated Phase 3 trials for MNKD-101 and Phase 1 trials for MNKD-201
Negative
- V-Go net revenue decreased 7% to $4.5M in Q2 2024
- R&D expenses increased by $5.4M to $11.8M in Q2 2024
- Loss on extinguishment of debt of $7.1M in Q2 2024
- Loss on available-for-sale securities of $1.6M in Q2 2024
News Market Reaction
On the day this news was published, MNKD declined 4.93%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Conference Call to Begin Today at 9:00 a.m. (ET)
- 2Q 2024 Total revenues of
$72M ; +49% vs. 2Q 2023 - YTD 2024 Total revenues of
$139M ; +55% vs. YTD 2023 - YTD 2024 Net income of
$9 million ; Non-GAAP net income of$29 million - Advances two orphan lung programs to human studies
- MNKD-101 Phase 3 clinical trial activities initiated
- MNKD-201 Phase 1 clinical trial on schedule to read out 4Q 2024
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 07, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended June 30, 2024.
“We achieved our ninth consecutive quarter of revenue growth and are approaching an annual revenue run rate of over
Second Quarter 2024 Results
Revenue Highlights
| Three Months Ended June 30, | ||||||||||||||||
| 2024 | 2023 | $ Change | % Change | |||||||||||||
| (Dollars in thousands) | ||||||||||||||||
| Royalties – collaboration | $ | 25,592 | $ | 19,055 | $ | 6,537 | 34 | % | ||||||||
| Revenue – collaborations and services | 26,014 | 11,211 | $ | 14,803 | 132 | % | ||||||||||
| Net revenue – Afrezza | 16,289 | 13,527 | $ | 2,762 | 20 | % | ||||||||||
| Net revenue – V-Go | 4,491 | 4,818 | $ | (327 | ) | (7 | %) | |||||||||
| Total revenues | $ | 72,386 | $ | 48,611 | $ | 23,775 | 49 | % | ||||||||
Second quarter royalties for Tyvaso DPI® increased
Commercial product gross margin in the second quarter of 2024 was
Cost of revenue – collaborations and services for the second quarter of 2024 was
Research and development ("R&D") expenses for the second quarter of 2024 were
Selling expenses were
General and administrative expenses were
Interest income, net, was
Interest expense on financing liability (related to the sale-leaseback of our Danbury manufacturing facility) was
Interest expense was
Interest expense on liability for sale of future royalties was
Loss on available-for-sale securities for the second quarter of 2024 was
Loss on extinguishment of debt of
First Half of 2024
Revenue Highlights
| Six Months Ended June 30, | ||||||||||||||||
| 2024 | 2023 | $ Change | % Change | |||||||||||||
| (Dollars in thousands) | ||||||||||||||||
| Royalties – collaboration | $ | 48,243 | $ | 30,733 | $ | 17,510 | 57 | % | ||||||||
| Revenue – collaborations and services | 50,862 | 22,597 | $ | 28,265 | 125 | % | ||||||||||
| Net revenue – Afrezza | 30,727 | 25,951 | $ | 4,776 | 18 | % | ||||||||||
| Net revenue – V-Go | 8,817 | 9,956 | $ | (1,139 | ) | (11 | %) | |||||||||
| Total revenues | $ | 138,649 | $ | 89,237 | $ | 49,412 | 55 | % | ||||||||
Royalties related to Tyvaso DPI for the first half of 2024 increased
Commercial product gross margin in the first half of 2024 was
Cost of revenue – collaborations and services for the first half of 2024 was
R&D expenses for the first half of 2024 were
Selling expenses were
General and administrative expenses for the first half of 2024 were
Interest income, net, was
Interest expense on financing liability (related to the sale-leaseback of our Danbury manufacturing facility) was
Interest expense was
Interest expense on liability for sale of future royalties was
Loss on available-for-sale securities for the first half of 2024 was
Loss on extinguishment of debt of
Cash, cash equivalents, restricted cash and investments as of June 30, 2024 were
Non-GAAP Measures
To supplement our condensed consolidated financial statements presented under U.S. generally accepted accounting principles ("GAAP"), we are presenting non-GAAP net income (loss) and non-GAAP net income (loss) per share - diluted, which are 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 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 measures 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.
| Three Months | Six Months | ||||||||||||||||||||||||||||||
| Ended June 30, | Ended June 30, | ||||||||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||||||||||
| Net Income (Loss) | Basic EPS | Net Loss | Basic EPS | Net Income | Basic EPS | Net Loss | Basic EPS | ||||||||||||||||||||||||
| (In thousands except per share data) | |||||||||||||||||||||||||||||||
| GAAP reported net income (loss) | $ | (2,014 | ) | $ | (0.01 | ) | $ | (5,265 | ) | $ | (0.02 | ) | $ | 8,616 | $ | 0.03 | $ | (15,060 | ) | $ | (0.06 | ) | |||||||||
| Non-GAAP adjustments: | |||||||||||||||||||||||||||||||
| Sold portion of royalty revenue (1) | (2,559 | ) | (0.01 | ) | — | — | (4,824 | ) | (0.02 | ) | — | — | |||||||||||||||||||
| Interest expense on liability for sale of future royalties | 4,383 | 0.02 | — | — | 8,631 | 0.03 | — | — | |||||||||||||||||||||||
| Stock compensation | 6,428 | 0.02 | 5,580 | 0.02 | 10,313 | 0.04 | 9,235 | 0.04 | |||||||||||||||||||||||
| (Gain) loss on foreign currency transaction | (529 | ) | — | 251 | — | (1,928 | ) | (0.01 | ) | 1,205 | — | ||||||||||||||||||||
| Loss (gain) on available-for-sale securities | 1,550 | 0.01 | (932 | ) | — | 1,550 | 0.01 | (932 | ) | — | |||||||||||||||||||||
| Loss on extinguishment of debt | 7,050 | 0.02 | — | — | 7,050 | 0.03 | — | — | |||||||||||||||||||||||
| Non-GAAP adjusted net income (loss) | $ | 14,309 | $ | 0.05 | $ | (366 | ) | $ | — | $ | 29,408 | $ | 0.11 | $ | (5,552 | ) | $ | (0.02 | ) | ||||||||||||
| Weighted average shares used to compute net income (loss) per share – basic | 273,056 | $ | 0.05 | 265,626 | $ | (0.00 | ) | 271,706 | $ | 0.11 | 264,802 | $ | (0.02 | ) | |||||||||||||||||
__________________________
(1) Represents the non-cash portion of the
Clinical Development Update
Afrezza INHALE-3 (T1DM, Afrezza vs. standard of care; phase 4 clinical trial)
- First meal dosing data published online in Diabetes Care in July 2024
- Randomized treatment phase top-line data/primary endpoints presented at American Diabetes Association conference in June 2024
- Inhaled insulin improved the ability to achieve target A1c (<
7% ) by76% over the standard of care (30% of Afrezza participants vs.17% on standard of care) 24% of Afrezza vs.13% on standard of care met time-in-range >70% with no increased hypoglycemia by continuous glucose monitoring- Over
50% of subjects at the end of the study expressed interest in continuing Afrezza - Met 17-week primary endpoint; full 30-week data expected to read out later this year
- Inhaled insulin improved the ability to achieve target A1c (<
- Additional data to be presented at Association of Diabetes Care and Education Specialists conference in August 2024
Afrezza INHALE-1 (pediatric phase 3 clinical trial)
- 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
MNKD-101 (clofazimine inhalation suspension)
- Phase 3 clinical trial activities initiated and site activation commenced in 2Q 2024
- Co-primary endpoints of sputum conversion and patient-reported outcomes
- Up to 120 global sites with 180 patients expected to be evaluated
MNKD-201 (nintedanib DPI)
- Phase 1 trial in healthy volunteers underway with first participant dosed in 2Q 2024
- Chronic toxicology and Phase 1 results expected in 4Q 2024
Conference Call
MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. The webcast will be accessible via a link on MannKind’s website at https://investors.mannkindcorp.com/events-and-presentations. A replay will also be available in the same location within 24 hours following the call and be accessible for approximately 90 days.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.
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 MannKind's annual revenue run rate; MannKind's ability to deliver sustainable short and long-term value for its shareholders; the expected timing of patient enrollment and dosing in clinical studies of MNKD-101; 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 Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 27, 2024, and subsequent periodic reports on Form 10-Q. 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 a trademark of United Therapeutics Corporation.
AFREZZA, MANNKIND, and V-GO are registered trademarks of MannKind Corporation.
| MANNKIND CORPORATION AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (In thousands except per share data) | ||||||||||||||||
| Revenues: | ||||||||||||||||
| Net revenue – commercial product sales | $ | 20,780 | $ | 18,345 | $ | 39,544 | $ | 35,907 | ||||||||
| Revenue – collaborations and services | 26,014 | 11,211 | 50,862 | 22,597 | ||||||||||||
| Royalties – collaboration | 25,592 | 19,055 | 48,243 | 30,733 | ||||||||||||
| Total revenues | 72,386 | 48,611 | 138,649 | 89,237 | ||||||||||||
| Expenses: | ||||||||||||||||
| Cost of goods sold | 5,605 | 5,224 | 9,424 | 10,754 | ||||||||||||
| Cost of revenue – collaborations and services | 14,772 | 9,013 | 29,551 | 19,696 | ||||||||||||
| Research and development | 11,816 | 6,453 | 21,829 | 12,058 | ||||||||||||
| Selling | 11,495 | 14,002 | 23,096 | 27,312 | ||||||||||||
| General and administrative | 12,617 | 11,947 | 23,345 | 22,489 | ||||||||||||
| (Gain) loss on foreign currency transaction | (529 | ) | 251 | (1,928 | ) | 1,205 | ||||||||||
| Total expenses | 55,776 | 46,890 | 105,317 | 93,514 | ||||||||||||
| Income (loss) from operations | 16,610 | 1,721 | 33,332 | (4,277 | ) | |||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 3,177 | 1,547 | 6,611 | 2,849 | ||||||||||||
| Interest expense on financing liability | (2,444 | ) | (2,449 | ) | (4,891 | ) | (4,873 | ) | ||||||||
| Interest expense | (6,051 | ) | (6,873 | ) | (8,618 | ) | (9,659 | ) | ||||||||
| Interest expense on liability for sale of future royalties | (4,383 | ) | — | (8,631 | ) | — | ||||||||||
| (Loss) gain on available-for-sale securities | (1,550 | ) | 932 | (1,550 | ) | 932 | ||||||||||
| Loss on extinguishment of debt | (7,050 | ) | — | (7,050 | ) | — | ||||||||||
| Other expense | — | (143 | ) | — | (32 | ) | ||||||||||
| Total other expense | (18,301 | ) | (6,986 | ) | (24,129 | ) | (10,783 | ) | ||||||||
| Income (loss) before income tax expense | (1,691 | ) | (5,265 | ) | 9,203 | (15,060 | ) | |||||||||
| Income tax expense | 323 | — | 587 | — | ||||||||||||
| Net income (loss) | $ | (2,014 | ) | $ | (5,265 | ) | $ | 8,616 | $ | (15,060 | ) | |||||
| Net income (loss) per share – basic | $ | (0.01 | ) | $ | (0.02 | ) | $ | 0.03 | $ | (0.06 | ) | |||||
| Weighted average shares used to compute net income (loss) per share – basic | 273,056 | 265,626 | 271,706 | 264,802 | ||||||||||||
| Net income (loss) per share – diluted | $ | (0.01 | ) | $ | (0.02 | ) | $ | 0.03 | $ | (0.06 | ) | |||||
| Weighted average shares used to compute net income (loss) per share – diluted | 273,056 | 265,626 | 279,358 | (1) | 264,802 | |||||||||||
__________________________
(1) Diluted weighted average shares ("DWAS") differs from basic due to the weighted average number of shares that would be outstanding upon conversion of convertible notes and exercise or vesting of outstanding share-based payments to employees. For the six months ended June 30, 2024, DWAS included 7,652 shares of outstanding share-based payments. 44,120 shares issuable upon conversion of our Senior convertible notes were excluded as their effect would be antidilutive.
| MANNKIND CORPORATION AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| (In thousands except share and per share data) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 96,643 | $ | 238,480 | ||||
| Short-term investments | 151,118 | 56,619 | ||||||
| Accounts receivable, net | 23,346 | 14,901 | ||||||
| Inventory | 24,753 | 28,545 | ||||||
| Prepaid expenses and other current assets | 30,080 | 34,848 | ||||||
| Total current assets | 325,940 | 373,393 | ||||||
| Restricted cash | 732 | — | ||||||
| Long-term investments | 13,398 | 7,155 | ||||||
| Property and equipment, net | 85,144 | 84,220 | ||||||
| Goodwill | 1,931 | 1,931 | ||||||
| Other intangible asset | 1,033 | 1,073 | ||||||
| Other assets | 15,658 | 7,426 | ||||||
| Total assets | $ | 443,836 | $ | 475,198 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 9,556 | $ | 9,580 | ||||
| Accrued expenses and other current liabilities | 40,952 | 42,036 | ||||||
| Liability for sale of future royalties – current | 12,149 | 9,756 | ||||||
| Financing liability – current | 9,935 | 9,809 | ||||||
| Deferred revenue – current | 7,420 | 9,085 | ||||||
| Recognized loss on purchase commitments – current | — | 3,859 | ||||||
| Midcap credit facility – current | — | 20,000 | ||||||
| Total current liabilities | 80,012 | 104,125 | ||||||
| Senior convertible notes | 227,577 | 226,851 | ||||||
| Liability for sale of future royalties – long term | 135,365 | 136,054 | ||||||
| Financing liability – long term | 94,094 | 94,319 | ||||||
| Deferred revenue – long term | 66,116 | 69,794 | ||||||
| Recognized loss on purchase commitments – long term | 60,183 | 60,942 | ||||||
| Operating lease liability | 3,272 | 3,925 | ||||||
| Financing lease liability | 184 | — | ||||||
| Milestone liabilities | 2,813 | 3,452 | ||||||
| Mann Group convertible note | — | 8,829 | ||||||
| Accrued interest – Mann Group convertible note | — | 56 | ||||||
| Midcap credit facility – long term | — | 13,019 | ||||||
| Total liabilities | 669,616 | 721,366 | ||||||
| Stockholders' deficit: | ||||||||
| Undesignated preferred stock, no shares issued or outstanding as of June 30, 2024 or December 31, 2023 | — | — | ||||||
| Common stock, 274,467,247 and 270,034,495 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | 2,740 | 2,700 | ||||||
| Additional paid-in capital | 2,992,271 | 2,980,539 | ||||||
| Accumulated deficit | (3,220,791 | ) | (3,229,407 | ) | ||||
| Total stockholders' deficit | (225,780 | ) | (246,168 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 443,836 | $ | 475,198 | ||||
FAQ
What was MannKind's (MNKD) total revenue for Q2 2024?
How much did Afrezza net revenue grow in Q2 2024 for MannKind (MNKD)?
What clinical trials did MannKind (MNKD) initiate in Q2 2024?
What was MannKind's (MNKD) net income for the first half of 2024?
