MannKind Corporation Reports 2023 Second Quarter Financial Results
Conference Call to Begin Today at
- 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
“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
Second Quarter 2023 Results
Revenue Highlights
| Three Months Ended |
||||||||||||||||
| 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 72% compared to 64% for the same period in 2022, primarily attributable to an increase in Afrezza net revenue, which has a higher gross margin than V-Go.
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 |
||||||||||||||||
| 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 70%, which was consistent with the same period in 2022.
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
Non-GAAP Measures
To supplement our unaudited 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 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 |
Ended |
||||||||||||||
| 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
About
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
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 |
Six Months Ended |
|||||||||||||||
| 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
| (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 | ||||||
| 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 | ||||||
| 8,829 | 8,829 | |||||||
| Accrued interest – |
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 | ||||
Source: MannKind