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 $275 million based on the first half of 2024,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We are excited about our future as we move our orphan lung programs into Phase 1 and Phase 3 studies and look forward to the additional Afrezza data read-outs later this year. We believe our diversification strategy of allocating capital towards our pipeline, in-line growth and debt reduction sets us up to deliver sustainable short and long-term value for our shareholders.”
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 $6.5 million, or 34%, over the same period in prior year due to increased sales by United Therapeutics ("UT"). Collaborations and services revenue increased $14.8 million, or 132%, compared to the same period in 2023 primarily attributable to an increase in manufacturing activities for Tyvaso DPI. Afrezza® net revenue for the second quarter of 2024 increased $2.8 million, or 20%, compared to the same period in 2023 primarily as a result of price (including a decrease in gross-to-net adjustments) and higher demand. V-Go® net revenue for the second quarter of 2024 decreased $0.3 million, or 7%, compared to the same period in 2023 as a result of lower product demand partially offset by increased price.
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 $14.8 million compared to $9.0 million for the same period in 2023. The $5.8 million increase was primarily attributable to increased manufacturing volume and related production activities for Tyvaso DPI. Higher manufacturing volumes resulted in efficiencies, which contributed to a lower effective cost per unit.
Research and development ("R&D") expenses for the second quarter of 2024 were $11.8 million compared to $6.5 million for the same period in 2023. The $5.4 million increase was primarily attributed to increased costs for development activities for clofazimine inhaled suspension (MNKD-101), an Afrezza pediatric clinical study (INHALE-1), and initiation of a Phase 1 clinical study of a dry-powder formulation of nintedanib (MNKD-201) for treatment of pulmonary fibrotic diseases, partially offset by lower costs for an Afrezza post-marketing clinical study (INHALE-3).
Selling expenses were $11.5 million for the second quarter of 2024 compared to $14.0 million for the same period in 2023. The $2.5 million decrease was primarily due to reduced personnel related to a sales force restructuring completed during the first quarter of 2024.
General and administrative expenses were $12.6 million for the second quarter of 2024 compared to $11.9 million for the same period in 2023. The $0.7 million increase was primarily attributable to increases in estimated returns associated with sales of V-Go that pre-date our acquisition of the product and personnel costs.
Interest income, net, was $3.2 million for the second quarter of 2024 compared to $1.5 million for the same period in 2023. The $1.6 million increase was primarily due to higher yields on our securities portfolio and an increase in the underlying investments from the proceeds of the sale of 1% of our Tyvaso DPI royalties in December 2023.
Interest expense on financing liability (related to the sale-leaseback of our Danbury manufacturing facility) was $2.4 million for the second quarter of 2024 and remained consistent with the same period in 2023.
Interest expense was $6.1 million for the second quarter of 2024 compared to $6.9 million for the same period in 2023. The decrease of $0.8 million was primarily due to repayment of the MidCap credit facility and Mann Group convertible note in April 2024.
Interest expense on liability for sale of future royalties was $4.4 million for the second quarter of 2024 and was attributable to imputed interest and amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023.
Loss on available-for-sale securities for the second quarter of 2024 was $1.6 million resulting from the modification of the Thirona note terms. Gain on available-for-sale securities for the same period in 2023 was $0.9 million as a result of the change in fair value of the Thirona investment relating to credit risk.
Loss on extinguishment of debt of $7.1 million for the second quarter of 2024 was incurred in connection with the prepayment of the MidCap credit facility and Mann Group convertible note in April 2024.
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 $17.5 million, or 57%, due to increased sales by UT. Collaborations and services revenue increased $28.3 million, or 125%, compared to the same period in 2023 primarily attributable to an increase in manufacturing activities for Tyvaso DPI. Afrezza net revenue for the first half of 2024 increased $4.8 million, or 18%, compared to the same period in 2023 primarily as a result of price (including a decrease in gross-to-net adjustments) and higher demand. V-Go net revenue for the first half of 2024 decreased $1.1 million, or 11%, compared to the same period in 2023 as a result of lower product demand partially offset by increased price.
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 $29.6 million compared to $19.7 million for the same period in 2023. The $9.9 million increase was primarily attributable to increased manufacturing volume and related production activities for product sold to UT.
R&D expenses for the first half of 2024 were $21.8 million compared to $12.1 million for the same period in 2023. The $9.8 million increase was primarily attributed to increased costs for development activities for MNKD-101, the INHALE-1 study, an Afrezza post-marketing clinical study (INHALE-3) which commenced in the second quarter of 2023, personnel expenses due to increased headcount, and initiation of a Phase 1 study of MNKD-201 for treatment of pulmonary fibrotic diseases.
Selling expenses were $23.1 million in the first half of 2024 compared to $27.3 million for the same period in 2023. The $4.2 million decrease was primarily due to reduced personnel and travel expenses related to a sales force restructuring completed during the first quarter of 2024.
General and administrative expenses for the first half of 2024 were $23.3 million compared to $22.5 million for the same period in 2023. The $0.9 million increase was primarily attributable to a loss of $1.4 million related to estimated returns associated with sales of V-Go that pre-date our acquisition of the product, partially offset by reduced personnel costs.
Interest income, net, was $6.6 million for the first half of 2024 compared to $2.8 million for the same period in 2023. The $3.8 million increase was primarily due to higher yields on our securities portfolio and an increase in the underlying investments from the proceeds of the sale of 1% of our Tyvaso DPI royalties in December 2023.
Interest expense on financing liability (related to the sale-leaseback of our Danbury manufacturing facility) was $4.9 million for the first half of 2024 and remained consistent with the same period in 2023.
Interest expense was $8.6 million for the first half of 2024 compared to $9.7 million for the same period in 2023. The decrease of $1.0 million was primarily due to repayment of the MidCap credit facility and Mann Group convertible note in April 2024.
Interest expense on liability for sale of future royalties was $8.6 million for the first half of 2024 and was attributable to imputed interest and amortization of debt issuance costs on the liability recorded in connection with the sale of 1% of our Tyvaso DPI royalties in December 2023.
Loss on available-for-sale securities for the first half of 2024 was $1.6 million resulting from the modification of the Thirona note terms. Gain on available-for-sale securities for the same period in 2023 was $0.9 million as a result of the change in fair value of the Thirona investment relating to credit risk.
Loss on extinguishment of debt of $7.1 million for the first half of 2024 was incurred in connection with the prepayment of the MidCap credit facility and the Mann Group convertible note in April 2024.
Cash, cash equivalents, restricted cash and investments as of June 30, 2024 were $261.9 million.
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 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 $25.6 million and $48.2 million, respectively, of which $2.6 million and $4.8 million, respectively, were attributed to the royalty purchaser.
Clinical Development Update
Afrezza INHALE-3 (T1DM, Afrezza vs. standard of care; phase 4 clinical trial)
Afrezza INHALE-1 (pediatric phase 3 clinical trial)
MNKD-101 (clofazimine inhalation suspension)
MNKD-201 (nintedanib DPI)
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, $0.01 par value – 10,000,000 shares authorized; no shares issued or outstanding as of June 30, 2024 or December 31, 2023 | — | — | ||||||
| Common stock, $0.01 par value – 800,000,000 shares authorized; 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 | ||||
| Last Trade: | US$7.17 |
| Daily Change: | 0.15 2.14 |
| Daily Volume: | 2,417,580 |
| Market Cap: | US$1.970B |
September 10, 2024 August 27, 2024 | |
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