MannKind Corporation Reports 2024 Third Quarter Financial Results and Provides Business Update
Conference Call to Begin Today at
- 3Q 2024 Total revenues of
$70M ; +37% vs. 3Q 2023 - YTD 2024 Total revenues of
$209M ; +49% vs. YTD 2023 - YTD 2024 Net income of
$20 million ; Non-GAAP net income of$45 million - Orphan lung disease studies proceeding as planned
- MNKD-101 Phase 3 clinical trial expands globally
- MNKD-201 Phase 1 successfully completed; Plan to meet with FDA in 1H 2025
“Our business demonstrated double-digit revenue growth compared to last year, led by Tyvaso DPI revenues,” said
Third Quarter 2024 Results
Revenue Highlights
| Three Months Ended |
||||||||||||||||
| 2024 | 2023 | $ Change | % Change | |||||||||||||
| (Dollars in thousands) | ||||||||||||||||
| Royalties – collaboration | $ | 27,083 | $ | 20,218 | $ | 6,865 | 34 | % | ||||||||
| Revenue – collaborations and services | 23,268 | 13,108 | $ | 10,160 | 78 | % | ||||||||||
| Net revenue – Afrezza | 15,035 | 13,476 | $ | 1,559 | 12 | % | ||||||||||
| Net revenue – V-Go | 4,693 | 4,451 | $ | 242 | 5 | % | ||||||||||
| Total revenues | $ | 70,079 | $ | 51,253 | $ | 18,826 | 37 | % | ||||||||
In the third quarter of 2024, compared to the same period in 2023:
- royalties for Tyvaso DPI® increased
$6.9 million , or 34%, due to increased sales by United Therapeutics ("UT"); - collaborations and services revenue increased
$10.2 million , or 78%, primarily attributable to an increase in manufacturing activities for Tyvaso DPI; - Afrezza® net revenue increased
$1.6 million , or 12%, as a result of higher demand and improved gross-to-net adjustments; and - V-Go® net revenue increased
$0.2 million , or 5%, as a result of improved gross-to-net adjustments and increased price, partially offset by lower product demand.
Commercial product gross margin in the third quarter of 2024 was 84% compared to 78% 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 third quarter of 2024 was
Research and development ("R&D") expenses for the third quarter of 2024 were
Selling expenses were
General and administrative expenses were
Interest income, net, was
Interest expense on liability for sale of future royalties was
Interest expense on financing liability related to the sale-leaseback of our
Interest expense was
Gain on bargain purchase of
Nine Months
Revenue Highlights
| Nine Months Ended |
||||||||||||||||
| 2024 | 2023 | $ Change | % Change | |||||||||||||
| (Dollars in thousands) | ||||||||||||||||
| Royalties – collaboration | $ | 75,326 | $ | 50,951 | $ | 24,375 | 48 | % | ||||||||
| Revenue – collaborations and services | 74,130 | 35,705 | $ | 38,425 | 108 | % | ||||||||||
| Net revenue – Afrezza | 45,762 | 39,427 | $ | 6,335 | 16 | % | ||||||||||
| Net revenue – V-Go | 13,510 | 14,407 | $ | (897 | ) | (6 | %) | |||||||||
| Total revenues | $ | 208,728 | $ | 140,490 | $ | 68,238 | 49 | % | ||||||||
For the nine months ended
- royalties related to Tyvaso DPI increased
$24.4 million , or 48%, due to increased sales by UT; - collaborations and services revenue increased
$38.4 million , or 108%, primarily attributable to an increase in manufacturing activities for Tyvaso DPI; - Afrezza net revenue for the nine months ended
September 30, 2024 increased$6.3 million , or 16%, primarily as a result of higher demand and price and improved gross-to-net adjustments; and - V-Go net revenue for the nine months ended
September 30, 2024 decreased$0.9 million , or 6%, as a result of lower product demand, partially offset by improved gross-to-net adjustments and increased price.
Commercial product gross margin in the nine months ended
Cost of revenue – collaborations and services for the nine months ended
R&D expenses for the nine months ended
Selling expenses were
General and administrative expenses for the nine months ended
Interest income, net, was
Interest expense on liability for sale of future royalties was
Interest expense on financing liability related to the sale-leaseback of our
Interest expense was
Gain on bargain purchase of
Loss on available-for-sale securities for the nine months ended
Loss on extinguishment of debt of
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 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 | Nine Months | ||||||||||||||||||||||||||||||
| Ended |
Ended |
||||||||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||||||||||
| Net Income | Basic EPS | Net Income | Basic EPS | Net Income | Basic EPS | Net Loss | Basic EPS | ||||||||||||||||||||||||
| (In thousands except per share data) | |||||||||||||||||||||||||||||||
| GAAP reported net income (loss) | $ | 11,550 | $ | 0.04 | $ | 1,721 | $ | 0.01 | $ | 20,166 | $ | 0.07 | $ | (13,339 | ) | $ | (0.05 | ) | |||||||||||||
| Non-GAAP adjustments: | |||||||||||||||||||||||||||||||
| Sold portion of royalty revenue(1) | (2,708 | ) | (0.01 | ) | — | — | (7,533 | ) | (0.03 | ) | — | — | |||||||||||||||||||
| Interest expense on liability for sale of future royalties | 4,089 | 0.02 | — | — | 12,720 | 0.04 | — | — | |||||||||||||||||||||||
| Stock compensation | 5,227 | 0.02 | 4,601 | 0.02 | 15,540 | 0.06 | 13,836 | 0.05 | |||||||||||||||||||||||
| Loss (gain) on foreign currency transaction | 2,454 | 0.01 | (2,065 | ) | (0.01 | ) | 526 | — | (860 | ) | — | ||||||||||||||||||||
| Gain on bargain purchase | (5,259 | ) | (0.02 | ) | — | — | (5,259 | ) | (0.02 | ) | — | — | |||||||||||||||||||
| Loss on extinguishment of debt | — | — | — | — | 7,050 | 0.03 | — | — | |||||||||||||||||||||||
| Loss (gain) on available-for-sale securities | — | — | — | — | 1,550 | 0.01 | (932 | ) | — | ||||||||||||||||||||||
| Non-GAAP adjusted net income (loss) | $ | 15,353 | $ | 0.06 | $ | 4,257 | $ | 0.02 | $ | 44,760 | $ | 0.16 | $ | (1,295 | ) | $ | (0.00 | ) | |||||||||||||
| Weighted average shares used to compute net income (loss) per share – basic | 274,998 | 268,732 | 272,811 | 266,126 | |||||||||||||||||||||||||||
__________________________
(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 3Q 2024 and the nine months ended
Clinical Development Update and Anticipated Milestones
Afrezza INHALE-3 (T1D, Afrezza vs. standard of care multiple daily injections or pumps) Phase 4 clinical trial
- Top-level 30-week results demonstrated that switching to or remaining on Afrezza allowed nearly twice as many people to get to the A1C (<7%) goal during the extension period
- Additional data to be presented at Advanced Technologies and Treatments for Diabetes (ATTD) and other conferences in 1H 2025
Afrezza INHALE-1 Pediatric Phase 3 clinical trial
- Primary endpoint analysis results expected in 4Q 2024
- Six-month data with safety extension expected in 1H 2025
- FDA submission for label expansion planned in 2025
MNKD-101 (Clofazimine Inhalation Suspension) Phase 3 (ICoN-1) clinical trial
- Trial cleared to proceed in four countries (U.S., Japan, South Korea and Australia) with a fifth (
Taiwan ) expected in 4Q 2024 - First patient randomized in the US in 3Q
- Approximately 230 participants to be randomized at 100+ sites for a minimum of 180 evaluable participants
MNKD-201 (nintedanib DPI) Phase 1 clinical trial
- Trial successfully completed, primary objective met demonstrating positive safety results and was well-tolerated in healthy volunteers
- Participants did not experience adverse events typically reported with oral nintedanib
- Preclinical chronic toxicology did not show any adverse findings
- FDA End-of-Phase 1 meeting expected in 1H 2025
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 global expansion in a clinical study of MNKD-101; the expected timing for data read-outs from clinical studies of Afrezza; timing for an end-of-Phase 1 meeting with the FDA for MNKD-201; and the timing of a planned FDA submission 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 developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of 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 CORPORATION AND SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
| Three Months Ended |
Nine Months Ended |
|||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (In thousands except per share data) | ||||||||||||||||
| Revenues: | ||||||||||||||||
| Net revenue – commercial product sales | $ | 19,728 | $ | 17,927 | $ | 59,272 | $ | 53,834 | ||||||||
| Revenue – collaborations and services | 23,268 | 13,108 | 74,130 | 35,705 | ||||||||||||
| Royalties – collaboration | 27,083 | 20,218 | 75,326 | 50,951 | ||||||||||||
| Total revenues | 70,079 | 51,253 | 208,728 | 140,490 | ||||||||||||
| Expenses: | ||||||||||||||||
| Cost of goods sold | 3,197 | 3,995 | 12,621 | 14,749 | ||||||||||||
| Cost of revenue – collaborations and services | 14,826 | 10,259 | 44,377 | 29,955 | ||||||||||||
| Research and development | 12,926 | 9,989 | 34,755 | 22,047 | ||||||||||||
| Selling | 13,093 | 13,440 | 36,189 | 40,752 | ||||||||||||
| General and administrative | 10,823 | 10,538 | 34,168 | 33,027 | ||||||||||||
| Loss (gain) on foreign currency transaction | 2,454 | (2,065 | ) | 526 | (860 | ) | ||||||||||
| Total expenses | 57,319 | 46,156 | 162,636 | 139,670 | ||||||||||||
| Income from operations | 12,760 | 5,097 | 46,092 | 820 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 3,179 | 1,580 | 9,790 | 4,429 | ||||||||||||
| Interest expense on liability for sale of future royalties | (4,089 | ) | — | (12,720 | ) | — | ||||||||||
| Interest expense on financing liability | (2,470 | ) | (2,459 | ) | (7,361 | ) | (7,332 | ) | ||||||||
| Interest expense | (1,801 | ) | (2,815 | ) | (10,419 | ) | (12,474 | ) | ||||||||
| Gain on bargain purchase | 5,259 | — | 5,259 | — | ||||||||||||
| Other income | 32 | 318 | 32 | 286 | ||||||||||||
| Loss on extinguishment of debt | — | — | (7,050 | ) | — | |||||||||||
| (Loss) gain on available-for-sale securities | — | — | (1,550 | ) | 932 | |||||||||||
| Total other expense | 110 | (3,376 | ) | (24,019 | ) | (14,159 | ) | |||||||||
| Income (loss) before income tax expense | 12,870 | 1,721 | 22,073 | (13,339 | ) | |||||||||||
| Income tax expense | 1,320 | — | 1,907 | — | ||||||||||||
| Net income (loss) | $ | 11,550 | $ | 1,721 | $ | 20,166 | $ | (13,339 | ) | |||||||
| Net income (loss) per share – basic | $ | 0.04 | $ | 0.01 | $ | 0.07 | $ | (0.05 | ) | |||||||
| Weighted average shares used to compute net income (loss) per share – basic | 274,998 | 268,732 | 272,811 | 266,126 | ||||||||||||
| Net income (loss) per share – diluted | $ | 0.04 | $ | 0.01 | $ | 0.07 | $ | (0.05 | ) | |||||||
| Weighted average shares used to compute net income (loss) per share – diluted | 284,693 | (1) | 323,770 | (1) | 281,407 | (1) | 266,126 | |||||||||
__________________________
(1) Diluted weighted average shares ("DWAS") differs from basic due to the weighted average number of shares that would be outstanding upon exercise or vesting of outstanding share-based payments to employees and conversion of convertible notes. For the three and nine 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 | $ | 62,373 | $ | 238,480 | ||||
| Short-term investments | 189,215 | 56,619 | ||||||
| Accounts receivable, net | 18,184 | 14,901 | ||||||
| Inventory | 26,663 | 28,545 | ||||||
| Prepaid expenses and other current assets | 31,229 | 34,848 | ||||||
| Total current assets | 327,664 | 373,393 | ||||||
| Restricted cash | 735 | — | ||||||
| Long-term investments | 16,796 | 7,155 | ||||||
| Property and equipment, net | 85,339 | 84,220 | ||||||
| 1,931 | 1,931 | |||||||
| Other intangible assets | 5,313 | 1,073 | ||||||
| Other assets | 26,422 | 7,426 | ||||||
| Total assets | $ | 464,200 | $ | 475,198 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,444 | $ | 9,580 | ||||
| Accrued expenses and other current liabilities | 37,386 | 42,036 | ||||||
| Liability for sale of future royalties – current | 11,755 | 9,756 | ||||||
| Financing liability – current | 9,998 | 9,809 | ||||||
| Deferred revenue – current | 6,518 | 9,085 | ||||||
| Recognized loss on purchase commitments – current | — | 3,859 | ||||||
| Midcap credit facility – current | — | 20,000 | ||||||
| Total current liabilities | 72,101 | 104,125 | ||||||
| Senior convertible notes | 227,941 | 226,851 | ||||||
| Liability for sale of future royalties – long term | 137,140 | 136,054 | ||||||
| Financing liability – long term | 94,005 | 94,319 | ||||||
| Deferred revenue – long term | 65,150 | 69,794 | ||||||
| Recognized loss on purchase commitments – long term | 62,638 | 60,942 | ||||||
| Operating lease liability | 12,167 | 3,925 | ||||||
| Milestone liabilities | 2,813 | 3,452 | ||||||
| Financing lease liability | 171 | — | ||||||
| Midcap credit facility – long term | — | 13,019 | ||||||
| — | 8,829 | |||||||
| Accrued interest – |
— | 56 | ||||||
| Total liabilities | 674,126 | 721,366 | ||||||
| Stockholders' deficit: | ||||||||
| Undesignated preferred stock, |
— | — | ||||||
| Common stock, |
2,753 | 2,700 | ||||||
| Additional paid-in capital | 2,995,974 | 2,980,539 | ||||||
| Accumulated other comprehensive income | 588 | — | ||||||
| Accumulated deficit | (3,209,241 | ) | (3,229,407 | ) | ||||
| Total stockholders' deficit | (209,926 | ) | (246,168 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 464,200 | $ | 475,198 | ||||
MannKind Contacts: Investor RelationsAna Kapor (818) 661-5000 Email: ir@mnkd.com Media RelationsChristie Iacangelo (818) 292-3500 Email: media@mnkd.com
Source: MannKind