MannKind Corporation Reports 2023 Second Quarter Financial Results
- 2Q 2023 total revenues increase by 157% YoY
- Tyvaso DPI royalties increase by 63% compared to 1Q 2023
- Afrezza net revenues increase by 27% YoY
- Commercial product gross margin improves to 72%
- None.
Conference Call to Begin Today at 5:00 p.m. (ET)
- 2Q 2023 Total revenues of
$49M ; +157% vs. 2Q 2022 - 2Q 2023 Tyvaso DPI royalties of
$19M ; +63% vs. 1Q 2023 - 2Q 2023 Endocrine Business Unit net revenues of
$18M ; Afrezza net revenues +27% vs. 2Q 2022 - 2Q 2023 Income from operations of
$2M ; Non-GAAP income from operations of$8M
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended June 30, 2023.
“We are excited to report positive income from operations in the second quarter driven by growing patient demand for Tyvaso DPI® and Afrezza as well as manufacturing revenues from Tyvaso DPI,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “In addition, we have optimized our commercial operations supporting Afrezza® and V-Go®, which is expected to get our Endocrine Business Unit to profitability starting in 2024.”
Second Quarter 2023 Results
Revenue Highlights
| Three Months Ended June 30, | ||||||||||||||||
| 2023 | 2022 | $ Change | % Change | |||||||||||||
| (Dollars in thousands) | ||||||||||||||||
| Net revenue – Afrezza | $ | 13,527 | $ | 10,649 | $ | 2,878 | 27 | % | ||||||||
| Net revenue – V-Go | 4,818 | 2,073 | $ | 2,745 | * | |||||||||||
| Revenue – collaborations and services | 11,211 | 5,868 | $ | 5,343 | 91 | % | ||||||||||
| Royalties – collaborations | 19,055 | 304 | $ | 18,751 | * | |||||||||||
| Total revenues | $ | 48,611 | $ | 18,894 | $ | 29,717 | 157 | % | ||||||||
________________________
* Not meaningful
Afrezza net revenue for the second quarter of 2023 increased
Commercial product gross margin in the second quarter of 2023 was
Cost of revenue – collaborations and services for the second quarter of 2023 was
Research and development ("R&D") expenses for the second quarter of 2023 were
Selling expenses for the second quarter of 2023 were
General and administrative expenses for the second quarter of 2023 were
Interest income was
Interest expense on financing liability was
Interest expense was
Gain on available-for-sale securities for the second quarter of 2023 was
First half of 2023
Revenue Highlights
| Six Months Ended June 30, | ||||||||||||||||
| 2023 | 2022 | $ Change | % Change | |||||||||||||
| Net revenue — Afrezza | $ | 25,951 | $ | 20,475 | $ | 5,476 | 27 | % | ||||||||
| Net revenue — V-Go | 9,956 | 2,073 | $ | 7,883 | * | |||||||||||
| Revenue — collaborations and services | 22,597 | 8,034 | $ | 14,563 | 181 | % | ||||||||||
| Royalties — collaborations | 30,733 | 304 | $ | 30,429 | * | |||||||||||
| Total revenues | $ | 89,237 | $ | 30,886 | $ | 58,351 | 189 | % | ||||||||
________________________
* Not meaningful
Afrezza net revenue for the first half of 2023 increased
Commercial product gross margin in the first half of 2023 was
Cost of revenue – collaborations and services for the first half of 2023 was
R&D expenses for the first half of 2023 were
Selling expenses for the first half of 2023 were
General and administrative expenses for the first half of 2023 were
Interest income was
Interest expense on financing liability was
Interest expense on notes was
Gain on available-for-sale securities for the first half of 2023 was
Cash, cash equivalents and investments as of June 30, 2023 were
Non-GAAP Measures
To supplement our unaudited condensed consolidated financial statements presented under U.S. generally accepted accounting principles (GAAP), we are presenting non-GAAP income (loss) from operations, non-GAAP net loss and non-GAAP net income (loss) per share, 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 unaudited 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 its 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 tables reconcile our financial measure for income (loss) from operations, net loss and earnings (loss) per share ("EPS") for basic and diluted weighted average shares as reported in our condensed consolidated statement of operations to a non-GAAP presentation as adjusted for the non-cash stock-based compensation expense and non-cash gain (loss) on foreign currency transactions for the periods presented:
| Three Months | Six Months | ||||||||||||||
| Ended June 30, | Ended June 30, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| (In thousands except per share data) | |||||||||||||||
| GAAP Income (loss) from operations | $ | 1,721 | $ | (20,454 | ) | $ | (4,277 | ) | $ | (41,710 | ) | ||||
| Increase (decrease) for excluded non-cash items: | |||||||||||||||
| Stock compensation | 5,580 | 4,422 | 9,235 | 7,228 | |||||||||||
| Loss (gain) on foreign currency transaction | 251 | (4,503 | ) | 1,205 | (6,486 | ) | |||||||||
| Non-GAAP income (loss) from operations | $ | 7,552 | $ | (20,535 | ) | $ | 6,163 | $ | (40,968 | ) | |||||
| GAAP net loss | $ | (5,265 | ) | $ | (29,023 | ) | $ | (15,060 | ) | $ | (55,021 | ) | |||
| Increase (decrease) for excluded non-cash items: | |||||||||||||||
| Stock compensation | 5,580 | 4,422 | 9,235 | 7,228 | |||||||||||
| Loss (gain) on foreign currency transaction | 251 | (4,503 | ) | 1,205 | (6,486 | ) | |||||||||
| Gain on available-for-sale securities | (932 | ) | — | (932 | ) | — | |||||||||
| Non-GAAP net loss | $ | (366 | ) | $ | (29,104 | ) | $ | (5,552 | ) | $ | (54,279 | ) | |||
| GAAP net loss per share - basic and diluted | $ | (0.02 | ) | $ | (0.11 | ) | $ | (0.06 | ) | $ | (0.22 | ) | |||
| Increase (decrease) for excluded non-cash items: | |||||||||||||||
| Stock compensation | 0.02 | 0.02 | 0.03 | 0.03 | |||||||||||
| Loss (gain) on foreign currency transaction | 0.00 | (0.02 | ) | 0.00 | (0.03 | ) | |||||||||
| Gain on available-for-sale securities | 0.00 | 0.00 | 0.00 | 0.00 | |||||||||||
| Non-GAAP net loss per share - basic and diluted | $ | 0.00 | $ | (0.11 | ) | $ | (0.03 | ) | $ | (0.22 | ) | ||||
| Weighted average shares - basic and diluted | 265,626 | 253,644 | 264,802 | 252,775 | |||||||||||
Conference Call
MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind's website for 14 days.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients 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, 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 optimization of our commercial operations for Afrezza and V-Go and the potential for our Endocrine Business Unit to reach profitability starting in 2024. 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 product commercialization, risks associated with developing product candidates, risks associated with MannKind’s ability to manage its existing cash resources or raise additional cash resources, 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, 2022, filed with the SEC on February 23, 2023, and under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, being filed with the SEC later today. 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 Contact:
Rose Alinaya, Investor Relations
(818) 661-5000
IR@mannkindcorp.com
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (In thousands except per share data) | ||||||||||||||||
| Revenues: | ||||||||||||||||
| Net revenue – commercial product sales | $ | 18,345 | $ | 12,722 | $ | 35,907 | $ | 22,548 | ||||||||
| Revenue – collaborations and services | 11,211 | 5,868 | 22,597 | 8,034 | ||||||||||||
| Royalties – collaborations | 19,055 | 304 | 30,733 | 304 | ||||||||||||
| Total revenues | 48,611 | 18,894 | 89,237 | 30,886 | ||||||||||||
| Expenses: | ||||||||||||||||
| Cost of goods sold | 5,224 | 4,617 | 10,754 | 6,901 | ||||||||||||
| Cost of revenue – collaborations and services | 9,013 | 8,298 | 19,696 | 17,012 | ||||||||||||
| Research and development | 6,453 | 4,893 | 12,058 | 8,429 | ||||||||||||
| Selling | 14,002 | 15,868 | 27,312 | 28,596 | ||||||||||||
| General and administrative | 11,947 | 10,175 | 22,489 | 18,144 | ||||||||||||
| Loss (gain) on foreign currency transaction | 251 | (4,503 | ) | 1,205 | (6,486 | ) | ||||||||||
| Total expenses | 46,890 | 39,348 | 93,514 | 72,596 | ||||||||||||
| Income (loss) from operations | 1,721 | (20,454 | ) | (4,277 | ) | (41,710 | ) | |||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 1,547 | 516 | 2,849 | 893 | ||||||||||||
| Interest expense on financing liability | (2,449 | ) | (2,443 | ) | (4,873 | ) | (4,814 | ) | ||||||||
| Interest expense | (6,873 | ) | (6,642 | ) | (9,659 | ) | (9,390 | ) | ||||||||
| Gain on available-for-sale securities | 932 | — | 932 | — | ||||||||||||
| Other expense | (143 | ) | — | (32 | ) | — | ||||||||||
| Total other expense | (6,986 | ) | (8,569 | ) | (10,783 | ) | (13,311 | ) | ||||||||
| Loss before income tax expense | (5,265 | ) | (29,023 | ) | (15,060 | ) | (55,021 | ) | ||||||||
| Benefit from income taxes | — | — | — | — | ||||||||||||
| Net loss | $ | (5,265 | ) | $ | (29,023 | ) | $ | (15,060 | ) | $ | (55,021 | ) | ||||
| Net loss per share – basic and diluted | $ | (0.02 | ) | $ | (0.11 | ) | $ | (0.06 | ) | $ | (0.22 | ) | ||||
| Weighted average shares used to compute net loss per share – basic and diluted | 265,626 | 253,644 | 264,802 | 252,775 | ||||||||||||
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2023 | December 31, 2022 | |||||||
| (In thousands except share and per share data) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 86,184 | $ | 69,767 | ||||
| Short-term investments | 58,163 | 101,079 | ||||||
| Accounts receivable, net | 27,789 | 16,801 | ||||||
| Inventory | 25,290 | 21,772 | ||||||
| Prepaid expenses and other current assets | 32,807 | 25,477 | ||||||
| Total current assets | 230,233 | 234,896 | ||||||
| Property and equipment, net | 69,510 | 45,126 | ||||||
| Goodwill | 1,931 | 2,428 | ||||||
| Other intangible asset | 1,113 | 1,153 | ||||||
| Long-term investments | 2,282 | 1,961 | ||||||
| Other assets | 8,353 | 9,718 | ||||||
| Total assets | $ | 313,422 | $ | 295,282 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 17,127 | $ | 11,052 | ||||
| Accrued expenses and other current liabilities | 36,833 | 35,553 | ||||||
| Financing liability – current | 9,686 | 9,565 | ||||||
| Midcap credit facility – current | 16,667 | — | ||||||
| Deferred revenue – current | 3,489 | 1,733 | ||||||
| Recognized loss on purchase commitments – current | 13,164 | 9,393 | ||||||
| Total current liabilities | 96,966 | 67,296 | ||||||
| Mann Group convertible note | 8,829 | 8,829 | ||||||
| Accrued interest – Mann Group convertible note | 55 | 55 | ||||||
| Financing liability – long term | 94,395 | 94,512 | ||||||
| Midcap credit facility – long term | 22,811 | 39,264 | ||||||
| Senior convertible notes | 226,124 | 225,397 | ||||||
| Recognized loss on purchase commitments – long term | 56,063 | 62,916 | ||||||
| Operating lease liability | 4,646 | 5,343 | ||||||
| Deferred revenue – long term | 60,248 | 37,684 | ||||||
| Milestone liabilities | 3,772 | 4,524 | ||||||
| Total liabilities | 573,909 | 545,820 | ||||||
| Stockholders' deficit: | ||||||||
| Undesignated preferred stock, | — | — | ||||||
| Common stock, | 2,682 | 2,638 | ||||||
| Additional paid-in capital | 2,968,917 | 2,964,293 | ||||||
| Accumulated other comprehensive income | 443 | — | ||||||
| Accumulated deficit | (3,232,529 | ) | (3,217,469 | ) | ||||
| Total stockholders' deficit | (260,487 | ) | (250,538 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 313,422 | $ | 295,282 | ||||
