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Mannkind Corporation Reports 2023 First Quarter Financial Results

  • 1Q 2023 Total Revenues of $41 million; +239% vs. 1Q 2022
  • 1Q 2023 Revenues associated with Tyvaso DPI of $23 million
  • 1Q 2023 Loss from operations decreased 72% vs. 1Q 2022 to $6 million
  • $167 million of Cash, Cash Equivalents and Investments at March 31, 2023

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended March 31, 2023.

“Demand for Tyvaso DPI® has been very strong, which resulted in $23 million in revenues in the first quarter of 2023,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “I'm excited about our inhaled platform and orphan lung pipeline as we get ready to launch our Phase 2/3 inhaled clofazimine trial for patients in the second half of 2023.”

Revenue Highlights

 Three Months
Ended March 31,
 
 2023 2022 $ Change % Change 
 (Dollars in thousands) 
Net revenue – Afrezza$12,423 $9,826 $2,597 26%
Net revenue – V-Go 5,139   $5,139 * 
Revenue – collaborations and services 11,386  2,166 $9,220 426%
Royalties – collaborations 11,678   $11,678 * 
Total revenues$40,626 $11,992 $28,634 239%

___________________
* Not meaningful

Afrezza® net revenue for the first quarter of 2023 increased compared to the same period in 2022 as a result of higher product demand, higher price (including a more favorable gross-to-net adjustment) and a more favorable cartridge mix. V-Go® was acquired in the second quarter of 2022. The increase in collaborations and services revenue reflected that the commercial manufacturing of Tyvaso DPI had not yet commenced in the prior period. Royalties related to Tyvaso DPI, launched in the second quarter of 2022 by United Therapeutics (“UT”), continued to grow based on strong patient demand.

Commercial product gross margin in the first quarter of 2023 was 69% compared to 77% for the same period in 2022 primarily related to the addition of V-Go in the second quarter of 2022 which had a lower gross margin than Afrezza.

Cost of revenue – collaborations and services for the first quarter of 2023 was $10.7 million compared to $8.7 million for the same period in 2022, an increase of $2.0 million, due to an increase in manufacturing activities for Tyvaso DPI.

Research and development expenses for the first quarter of 2023 were $5.6 million compared to $3.5 million for the same period in 2022. The $2.1 million increase was primarily attributed to costs incurred to develop our product pipeline, including MNKD-101 (inhaled clofazimine) and the Afrezza pediatrics clinical study (INHALE-1).

Selling expenses for the first quarter of 2023 were $13.3 million compared to $12.7 million for the same period in 2022. The $0.6 million increase was primarily due to V-Go promotional efforts and increased headcount after the acquisition in the second quarter of 2022 as well as an increase in Afrezza promotional activities, partially offset by the termination of an Afrezza pilot promotional effort targeting primary care physicians which ended in the third quarter of 2022.

General and administrative expenses for the first quarter of 2023 were $10.5 million compared to $7.9 million for the same period in 2022. The $2.6 million increase was primarily attributable to higher stock-based compensation, increased headcount, and higher professional fees.

Interest expense on financing liability was $2.4 million for the first quarter of 2023 and remained consistent with the same period in 2022.

Interest expense on notes was $2.8 million in the first quarter of 2023 and remained consistent with the same period in 2022 due to fixed interest rates and no changes in debt balances.

Cash, cash equivalents and investments as of March 31, 2023 were $166.6 million.

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 MannKind’s pipeline advancement, including the planned launch of MannKind's inhaled clofazimine trial for patients in the second half of 2023. 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 these 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 March 31, 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 March 31,
 
 2023  2022 
 (In thousands except per share data) 
Revenues:     
Net revenue – commercial product sales$17,562  $9,826 
Revenue – collaborations and services 11,386   2,166 
Royalties – collaborations 11,678    
Total revenues 40,626   11,992 
Expenses:     
Cost of goods sold 5,530   2,284 
Cost of revenue – collaborations and services 10,683   8,714 
Research and development 5,605   3,536 
Selling 13,310   12,728 
General and administrative 10,542   7,969 
Loss (gain) on foreign currency transaction 954   (1,983)
Total expenses 46,624   33,248 
Loss from operations (5,998)  (21,256)
Other (expense) income:     
Interest income, net 1,302   377 
Interest expense on financing liability (2,424)  (2,371)
Interest expense on notes (2,786)  (2,748)
Other income 111    
Total other expense (3,797)  (4,742)
Loss before income tax expense (9,795)  (25,998)
Benefit from income taxes     
Net loss$(9,795) $(25,998)
Net loss per share – basic and diluted$(0.04) $(0.10)
Shares used to compute net loss per share
   – basic and diluted
 263,969   251,887 
        
        

MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS

   
 March 31, 
 2023  2022 
 (In thousands except share and per share data) 
ASSETS     
Current assets:     
Cash and cash equivalents$85,869  $69,767 
Short-term investments 80,273   101,079 
Accounts receivable, net 19,714   16,801 
Inventory 21,998   21,772 
Prepaid expenses and other current assets 15,445   25,477 
Total current assets 223,299   234,896 
Property and equipment, net 54,837   45,126 
Goodwill 1,998   2,428 
Other intangible asset 1,133   1,153 
Long-term investments 492   1,961 
Other assets 16,378   9,718 
Total assets$298,137  $295,282 
      
LIABILITIES AND STOCKHOLDERS' DEFICIT     
Current liabilities:     
Accounts payable$13,889  $11,052 
Accrued expenses and other current liabilities 32,995   35,553 
Financing liability – current 9,626   9,565 
Midcap credit facility – current 11,667    
Deferred revenue – current 2,316   1,733 
Recognized loss on purchase commitments – current 11,360   9,393 
Total current liabilities 81,853   67,296 
Mann Group convertible note 8,829   8,829 
Accrued interest – Mann Group convertible note 54   55 
Financing liability – long term 94,441   94,512 
Midcap credit facility 27,704   39,264 
Senior convertible notes 225,761   225,397 
Recognized loss on purchase commitments – long term 59,829   62,916 
Operating lease liability 4,879   5,343 
Deferred revenue – long term 45,659   37,684 
Milestone liabilities 4,524   4,524 
Deposits from customer     
Total liabilities 553,533   545,820 
Stockholders' deficit:     
Undesignated preferred stock, $0.01 par value – 10,000,000 shares
   authorized; no shares issued or outstanding as of March 31, 2023
   and December 31, 2022
     
Common stock, $0.01 par value – 400,000,000 shares authorized,
   264,278,760 and 263,793,305 shares issued and outstanding as of
   March 31, 2023 and December 31, 2022, respectively
 2,643   2,638 
Additional paid-in capital 2,969,225   2,964,293 
Accumulated deficit (3,227,264)  (3,217,469)
Total stockholders' deficit (255,396)  (250,538)
Total liabilities and stockholders' deficit$298,137  $295,282 

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