MannKind Corporation Reports 2024 First Quarter Financial Results: Provides Clinical Development Update

Published

Conference Call to Begin Today at 5:00 p.m. (ET)

  • 1Q 2024 Total revenues of $66M; +63% vs. 1Q 2023
  • 1Q 2024 Net income of $11M; Non-GAAP net income of $15M
  • $304M of cash and cash equivalents and investments at March 31, 2024
  • In early April, repaid Midcap senior-secured debt and Mann Group convertible debt totaling approximately $37M
  • FDA Fast Track designation and IND clearance received for MNKD-101

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended March 31, 2024.

“We achieved our eighth consecutive quarter of revenue growth putting us on a run rate of over $250 million in revenue for 2024,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “In the last week, we received Fast Track designation and clearance of the IND for MNKD-101 which may allow us to bring this innovative product to patients more quickly.”

Revenue Highlights

  Three Months Ended March 31, 
  2024  2023  $ Change  % Change 
  (Dollars in thousands) 
Royalties – collaborations $22,651  $11,678  $10,973   94%
Revenue – collaborations and services  24,848   11,386  $13,462   118%
Net revenue – Afrezza  14,438   12,423  $2,015   16%
Net revenue – V-Go  4,326   5,139  $(813)  (16%)
Total revenues $66,263  $40,626  $25,637   63%
                 

Royalties related to Tyvaso DPI for the first quarter of 2024 increased $11.0 million, or 94%, due to increased patient demand. Collaborations and services revenue increased $13.5 million, or 118%, compared to the same period in 2023 primarily attributable to an increase in manufacturing Tyvaso DPI for United Therapeutics ("UT"). Afrezza® net revenue for the first quarter of 2024 increased $2.0 million, or 16%, compared to the same period in 2023 as a result of higher price (including a decrease in gross-to-net adjustments). V-Go® net revenue for the first quarter of 2024 decreased $0.8 million, or 16%, compared to the same period in 2023 as a result of lower product demand.

Commercial product gross margin in the first quarter of 2024 was 80% compared to 69% 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 quarter of 2024 was $14.8 million compared to $10.7 million for the same period in 2023. The $4.1 million increase was primarily attributable to increased manufacturing volume and related production activities. Higher manufacturing volumes resulted in efficiencies which contributed to a lower effective cost per unit.

Research and development ("R&D") expenses for the first quarter of 2024 were $10.0 million compared to $5.6 million for the same period in 2023. The $4.4 million increase was primarily attributed to increased development activities for clofazimine inhaled suspension (MNKD-101), costs for an Afrezza post-marketing clinical study (INHALE-3) which commenced in the second quarter of 2023 and personnel expenses due to increased headcount. Selling expenses were $11.6 million in the first quarter of 2024 compared to $13.3 million for the same period in 2023. The $1.7 million decrease was primarily due to reduced personnel and travel expenses related to sales force restructuring activities completed during the quarter.

General and administrative expenses for the first quarter of 2024 were $10.7 million compared to $10.5 million for the same period in 2023. The $0.2 million increase was primarily attributable to a loss of $1.2 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 $3.4 million for the first quarter of 2024 compared to $1.3 million for the same period in 2023. The $2.1 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 notes was $2.6 million and interest expense on financing liability (related to the sale-leaseback of our Danbury manufacturing facility) was $2.4 million for the first quarter of 2024 and remained consistent with the same period in 2023.

Interest expense on liability for sale of future royalties was $4.2 million for the first quarter of 2024 due to imputed interest and amortization of debt issuance costs on the liability recorded in connection with the sale of a portion of our future royalties in December 2023.

Cash, cash equivalents and investments as of March 31, 2024 were $304.5 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 measure 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 as adjusted for select non-cash items: 1% royalty on net revenues for Tyvaso DPI ("sold portion of royalty revenue") and interest expense on the related liability, stock-based compensation expense and (gain) loss on foreign currency transaction for the periods presented:

 Three Months 
 Ended March 31, 
 2024  2023 
 Net Income  Diluted EPS  Net Loss  Diluted EPS 
 (In thousands except per share data) 
GAAP reported$10,630  $0.04  $(9,795) $(0.04)
Select non-cash adjustments:           
Sold portion of royalty revenue (1) (2,265)  (0.01)      
Interest expense on liability for sale of future royalties 4,248   0.01       
Stock compensation 3,885   0.01   3,655   0.01 
(Gain) loss on foreign currency transaction (1,399)     954   0.01 
Non-GAAP adjusted$15,099  $0.05  $(5,186) $(0.02)
Weighted average shares used to compute net income (loss) per share – diluted 324,733      263,969    

__________________________ (1)         Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during 1Q 2024 which is remitted to the royalty purchaser and recognized as royalties from collaborations in our consolidated statements of operations. Our revenues from royalties from collaborations during 1Q 2024 totaled $22.7 million, of which $2.3 million will be remitted to the royalty purchaser.

Clinical Development Update

Afrezza INHALE-1 (pediatric phase 3 clinical trial)

  • Patient enrollment and randomization completed in 1Q 2024
  • 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

Afrezza INHALE-3 (T1DM, Afrezza vs. standard of care including AID pumps; phase 4 clinical trial)

  • Last participant completed randomized treatment phase in 1Q 2024
  • First meal dosing presented at ATTD conference in March 2024
  • Upcoming expected data read-outs:
    • Randomized treatment phase top-line data/primary endpoints to be presented at ADA conference in June 2024
    • Additional data to be presented at ADCES August conference

MNKD-101 (clofazimine inhalation suspension)

  • Fast Track designation received from the FDA
  • FDA clearance of Investigational New Drug Application ("IND")
  • Co-primary endpoints of sputum conversion and patient-reported outcomes
  • Up to 120 global sites, first patient expected to enroll in 2Q 2024

MNKD-201 (nintedanib DPI)

  • FDA clearance to proceed to Phase 1 clinical trial
  • Phase 1 development program in healthy volunteers, expected to dose first patient in 2Q 2024
  • Results expected in late 2024

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 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 the expected timing of patient enrollment and dosing in clinical studies of MNKD-101 and MNKD-201; the potential for expedited review of a regulatory submission for MNKD-101 and the potential to bring MNKD-101 to patients more quickly; 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, as updated by the "Risk Factors" in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, 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 March 31, 
  2024  2023 
  (In thousands except per share data) 
Revenues:      
Net revenue – commercial product sales $18,764  $17,562 
Revenue – collaborations and services  24,848   11,386 
Royalties – collaborations  22,651   11,678 
Total revenues  66,263   40,626 
Expenses:      
Cost of goods sold  3,819   5,530 
Cost of revenue – collaborations and services  14,779   10,683 
Research and development  10,013   5,605 
Selling  11,601   13,310 
General and administrative  10,728   10,542 
(Gain) loss on foreign currency transaction  (1,399)  954 
Total expenses  49,541   46,624 
Income (loss) from operations  16,722   (5,998)
Other income (expense):      
Interest income, net  3,434   1,302 
Interest expense on financing liability  (2,447)  (2,424)
Interest expense  (2,567)  (2,786)
Interest expense on liability for sale of future royalties  (4,248)   
Other income     111 
Total other expense  (5,828)  (3,797)
Income (loss) before income tax expense  10,894   (9,795)
Income tax expense  264    
Net income (loss) $10,630  $(9,795)
Net income (loss) per share – basic $0.04  $(0.04)
Weighted average shares used to compute net income (loss) per share – basic  270,356   263,969 
Net income (loss) per share – diluted $0.04  (1)$(0.04)
Weighted average shares used to compute net income (loss) per share – diluted  324,733  (2) 263,969 

__________________________

(1) The calculation of diluted EPS includes an add back of interest expense to net income which represents interest that would not be recognized if the conversion of our Senior convertible notes and Mann Group convertible note were converted to shares of our common stock. The related interest expense for 1Q 2024 was $1,856 and resulted in adjusted net income of $12,486. These adjustments are only applied to periods with net income.

(2) Diluted weighted average shares differs from basic due to the weighted average number of shares that would be outstanding upon conversion of our Senior convertible notes (44,120 shares) and Mann Group convertible note (3,370 shares), and exercise or vesting of outstanding share-based payments to employees (6,887 shares). These adjustments to weighted average shares are only applied to periods with net income.

MANNKIND CORPORATION AND SUBSIDIARY CONDENSED CONSOLIDATED BALANCE SHEETS
       
  March 31, 2024  December 31, 2023 
  (In thousands except share and per share data) 
ASSETS      
Current assets:      
Cash and cash equivalents $193,272  $238,480 
Short-term investments  107,457   56,619 
Accounts receivable, net  19,912   14,901 
Inventory  26,442   28,545 
Prepaid expenses and other current assets  36,019   34,848 
Total current assets  383,102   373,393 
Property and equipment, net  83,620   84,220 
Goodwill  1,931   1,931 
Other intangible asset  1,053   1,073 
Long-term investments  3,726   7,155 
Other assets  7,447   7,426 
Total assets $480,879  $475,198 
       
LIABILITIES AND STOCKHOLDERS' DEFICIT      
Current liabilities:      
Accounts payable $7,149  $9,580 
Accrued expenses and other current liabilities  42,291   42,036 
Financing liability – current  9,872   9,809 
Midcap credit facility – current  20,000    
Liability for sale of future royalties – current  10,537   9,756 
Deferred revenue – current  7,601   9,085 
Recognized loss on purchase commitments – current  2,446   3,859 
Total current liabilities  99,896   104,125 
Mann Group convertible note  8,829   8,829 
Accrued interest – Mann Group convertible note  55   56 
Financing liability – long term  94,207   94,319 
Midcap credit facility – long term  8,105   13,019 
Senior convertible notes  227,214   226,851 
Liability for sale of future royalties – long term  137,418   136,054 
Recognized loss on purchase commitments – long term  60,287   60,942 
Operating lease liability  3,645   3,925 
Deferred revenue – long term  67,741   69,794 
Milestone liabilities  3,452   3,452 
Total liabilities  710,849   721,366 
Stockholders' deficit:      
Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized; no shares issued or outstanding as of March 31, 2024 or December 31, 2023      
Common stock, $0.01 par value – 800,000,000 shares authorized; 270,801,781 and 270,034,495 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively  2,703   2,700 
Additional paid-in capital  2,986,104   2,980,539 
Accumulated deficit  (3,218,777)  (3,229,407)
Total stockholders' deficit  (229,970)  (246,168)
Total liabilities and stockholders' deficit $480,879  $475,198 

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Source: MannKind

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