MannKind Corporation Reports 2024 Second Quarter Financial Results: Provides Clinical Development Update
- 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
“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 |
||||||||||||||||
| 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 73% compared to 72% 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 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
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 |
||||||||||||||||
| 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 76% compared to 70% 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 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
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
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 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 |
Ended |
||||||||||||||||||||||||||||||
| 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 1% royalty on net sales of Tyvaso DPI earned during the periods presented which is remitted to the royalty purchaser and recognized as royalties – collaboration in our consolidated statements of operations. Our revenues from royalties – collaboration during 2Q 2024 and the first half of 2024 totaled
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 inJune 2024 - Inhaled insulin improved the ability to achieve target A1c (<7%) by 76% 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
- Additional data to be presented at
Association of Diabetes Care and Education Specialists conference inAugust 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
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
Tyvaso DPI is a trademark of United Therapeutics Corporation.
AFREZZA,
| MANNKIND CORPORATION AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| 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
| MANNKIND CORPORATION AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
| (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 | ||||||
| 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 | ||||||
| — | 8,829 | |||||||
| Accrued interest – |
— | 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 |
— | — | ||||||
| Common stock, 274,467,247 and 270,034,495 shares issued and outstanding as of |
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 | ||||
MannKind Contact:Chris Prentiss , CFO (818) 661-5000 IR@mannkindcorp.com
Source: MannKind