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MannKind Company Stories 2024 Third Quarter Monetary Outcomes and Offers Enterprise Replace – MannKind (NASDAQ:MNKD)

Date:

Convention Name to Start At present at 4:30 p.m. (ET)

  • 3Q 2024 Whole revenues of $70M; +37% vs. 3Q 2023
  • YTD 2024 Whole revenues of $209M; +49% vs. YTD 2023
  • YTD 2024 Internet revenue of $20 million; Non-GAAP internet revenue of $45 million
  • Orphan lung illness research continuing as deliberate
    • MNKD-101 Part 3 medical trial expands globally
    • MNKD-201 Part 1 efficiently accomplished; Plan to satisfy with FDA in 1H 2025

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) — MannKind Company MNKD right this moment reported monetary outcomes for the quarter ended September 30, 2024.

“Our enterprise demonstrated double-digit income development in comparison with final 12 months, led by Tyvaso DPI revenues,” mentioned Michael Castagna, PharmD, Chief Govt Officer of MannKind Company. “The third quarter has additionally been marked by sturdy progress in our medical improvement packages, with enrollment underway within the Part 3 trial of MNKD-101 to review its impact in NTM lung illness and profitable completion of a Part 1 trial of MNKD-201 for IPF. We additionally lately introduced optimistic topline outcomes from the Afrezza INHALE-3 post-marketing research and anticipate to announce topline knowledge from the Part-3 INHALE-1 pediatric research by year-end.”

Third Quarter 2024 Outcomes

Income Highlights

    Three Months
Ended September 30,
 
    2024     2023     $ Change     % Change  
    ({Dollars} in hundreds)  
Royalties – collaboration   $ 27,083     $ 20,218     $ 6,865       34 %
Income – collaborations and companies     23,268       13,108     $ 10,160       78 %
Internet income – Afrezza     15,035       13,476     $ 1,559       12 %
Internet income – V-Go     4,693       4,451     $ 242       5 %
Whole revenues   $ 70,079     $ 51,253     $ 18,826       37 %
                                 

Within the third quarter of 2024, in comparison with the identical interval in 2023:

  • royalties for Tyvaso DPI® elevated $6.9 million, or 34%, as a consequence of elevated gross sales by United Therapeutics (“UT”);
  • collaborations and companies income elevated $10.2 million, or 78%, primarily attributable to a rise in manufacturing actions for Tyvaso DPI;
  • Afrezza® internet income elevated $1.6 million, or 12%, on account of larger demand and improved gross-to-net changes; and
  • V-Go® internet income elevated $0.2 million, or 5%, on account of improved gross-to-net changes and elevated value, partially offset by decrease product demand.

Business product gross margin within the third quarter of 2024 was 84% in comparison with 78% for a similar interval in 2023. The rise in gross margin was primarily attributable to a rise in Afrezza internet income.

Value of income – collaborations and companies for the third quarter of 2024 was $14.8 million in comparison with $10.3 million for a similar interval in 2023. The $4.5 million improve was primarily attributable to elevated manufacturing quantity for Tyvaso DPI.

Analysis and improvement (“R&D”) bills for the third quarter of 2024 had been $12.9 million in comparison with $10.0 million for a similar interval in 2023. The $2.9 million improve was primarily attributed to elevated prices for a Part 3 medical research of MNKD-101, a Part 1 medical research of a dry-powder formulation of MNKD-201, and personnel prices as a consequence of elevated headcount following a transaction with Pulmatrix, Inc.

Promoting bills had been $13.1 million for the third quarter of 2024 in comparison with $13.4 million for a similar interval in 2023. The $0.3 million lower was primarily as a consequence of diminished personnel prices associated to a gross sales pressure restructuring accomplished through the first quarter of 2024, partially offset by a rise in promotional actions.

Normal and administrative bills had been $10.8 million for the third quarter of 2024 in comparison with $10.5 million for a similar interval in 2023. The $0.3 million improve was primarily attributable to will increase in personnel prices partially offset by diminished consulting charges.

Curiosity revenue, internet, was $3.2 million for the third quarter of 2024 in comparison with $1.6 million for a similar interval in 2023. The $1.6 million improve was primarily as a consequence of a rise within the underlying investments from the proceeds of the sale of 1% of our Tyvaso DPI royalties in December 2023 and better yields on our securities portfolio.

Curiosity expense on legal responsibility on the market of future royalties was $4.1 million for the third quarter of 2024 and was attributable to imputed curiosity and amortization of debt issuance prices on the legal responsibility recorded in reference to the sale of 1% of our Tyvaso DPI royalties in December 2023.

Curiosity expense on financing legal responsibility associated to the sale-leaseback of our Danbury manufacturing facility was $2.5 million for the third quarter of 2024 and remained in keeping with the identical interval in 2023.

Curiosity expense was $1.8 million for the third quarter of 2024 in comparison with $2.8 million for a similar interval in 2023. The lower of $1.0 million was primarily as a consequence of compensation of the MidCap credit score facility and Mann Group convertible word in April 2024.

Achieve on discount buy of $5.3 million for the third quarter of 2024 was the results of the surplus of the honest worth of internet property acquired over the honest worth of the consideration paid within the Pulmatrix transaction.

9 Months September 30, 2024

Income Highlights

    9 Months
Ended September 30,
 
    2024     2023     $ Change     % Change  
    ({Dollars} in hundreds)  
Royalties – collaboration   $ 75,326     $ 50,951     $ 24,375       48 %
Income – collaborations and companies     74,130       35,705     $ 38,425       108 %
Internet income – Afrezza     45,762       39,427     $ 6,335       16 %
Internet income – V-Go     13,510       14,407     $ (897 )     (6 %)
Whole revenues   $ 208,728     $ 140,490     $ 68,238       49 %
                                 

For the 9 months ended September 30, 2024, in comparison with the identical interval in 2023:

  • royalties associated to Tyvaso DPI elevated $24.4 million, or 48%, as a consequence of elevated gross sales by UT;
  • collaborations and companies income elevated $38.4 million, or 108%, primarily attributable to a rise in manufacturing actions for Tyvaso DPI;
  • Afrezza internet income for the 9 months ended September 30, 2024 elevated $6.3 million, or 16%, primarily on account of larger demand and value and improved gross-to-net changes; and
  • V-Go internet income for the 9 months ended September 30, 2024 decreased $0.9 million, or 6%, on account of decrease product demand, partially offset by improved gross-to-net changes and elevated value.

Business product gross margin within the 9 months ended September 30, 2024 was 79% in comparison with 73% for a similar interval in 2023. The rise in gross margin was primarily attributable to a rise in Afrezza internet income.

Value of income – collaborations and companies for the 9 months ended September 30, 2024 was $44.4 million in comparison with $30.0 million for a similar interval in 2023. The $14.4 million improve was primarily attributable to elevated manufacturing quantity for product offered to UT.

R&D bills for the 9 months ended September 30, 2024 had been $34.8 million in comparison with $22.0 million for a similar interval in 2023. The $12.8 million improve was primarily attributed to elevated expenditures for improvement actions and a Part 3 medical research of MNKD-101, a Part 1 research of MNKD-201, and personnel prices as a consequence of elevated headcount on account of the Pulmatrix transaction.

Promoting bills had been $36.2 million within the 9 months ended September 30, 2024 in comparison with $40.8 million for a similar interval in 2023. The $4.6 million lower was primarily as a consequence of diminished personnel prices associated to a gross sales pressure restructuring accomplished through the first quarter of 2024.

Normal and administrative bills for the 9 months ended September 30, 2024 had been $34.2 million in comparison with $33.0 million for a similar interval in 2023. The $1.2 million improve was primarily attributable to a lack of $1.4 million associated to estimated returns related to gross sales of V-Go that pre-date our acquisition of the product and will increase in personnel prices, partially offset by diminished consulting charges.

Curiosity revenue, internet, was $9.8 million for the 9 months ended September 30, 2024 in comparison with $4.4 million for a similar interval in 2023. The $5.4 million improve was primarily as a consequence of a rise within the underlying investments from the proceeds of the sale of 1% of our Tyvaso DPI royalties in December 2023 and better yields on our securities portfolio.

Curiosity expense on legal responsibility on the market of future royalties was $12.7 million for the 9 months ended September 30, 2024 and was attributable to imputed curiosity and amortization of debt issuance prices on the legal responsibility recorded in reference to the sale of 1% of our Tyvaso DPI royalties in December 2023.

Curiosity expense on financing legal responsibility associated to the sale-leaseback of our Danbury manufacturing facility was $7.4 million for the 9 months ended September 30, 2024 and remained in keeping with the identical interval in 2023.

Curiosity expense was $10.4 million for the 9 months ended September 30, 2024 in comparison with $12.5 million for a similar interval in 2023. The lower of $2.1 million was primarily as a consequence of compensation of the MidCap credit score facility and Mann Group convertible word in April 2024.

Achieve on discount buy of $5.3 million for the 9 months ended September 30, 2024 was the results of the surplus of the honest worth of internet property acquired over the honest worth of the consideration paid within the Pulmatrix transaction.

Loss on available-for-sale securities for the 9 months ended September 30, 2024 was $1.6 million ensuing from the modification of the Thirona word phrases. Achieve on available-for-sale securities for a similar interval in 2023 was $0.9 million on account of the change in honest worth of the Thirona funding.

Loss on extinguishment of debt of $7.1 million for the 9 months ended September 30, 2024 was incurred in reference to the prepayment of the MidCap credit score facility and the Mann Group convertible word in April 2024.

Money, money equivalents and investments as of September 30, 2024 had been $268.4 million.

Non-GAAP Measures

To complement our condensed consolidated monetary statements offered underneath U.S. usually accepted accounting ideas (“GAAP”), we’re presenting non-GAAP internet revenue (loss) and non-GAAP internet revenue (loss) per share – diluted, that are non-GAAP monetary measures. We’re offering these non-GAAP monetary measures to reveal further data to facilitate the comparability of previous and current operations, and they’re among the many indicators administration makes use of as a foundation for evaluating our monetary efficiency. We consider that these non-GAAP monetary measures, when thought of along with our GAAP monetary outcomes, present administration and traders with an extra understanding of our enterprise working outcomes, together with underlying tendencies.

These non-GAAP monetary measures aren’t meant to be thought of in isolation or as an alternative choice to comparable GAAP measures; must be learn at the side of our condensed consolidated monetary statements ready in accordance with GAAP; don’t have any standardized that means prescribed by GAAP; and aren’t ready underneath any complete set of accounting guidelines or ideas. As well as, sometimes sooner or later there could also be different objects that we could exclude for functions of our non-GAAP monetary measures; and we could sooner or later stop to exclude objects that we have now traditionally excluded for functions of our non-GAAP monetary measures. Likewise, we could decide to switch the character of changes to reach at our non-GAAP monetary measures. Due to the non-standardized definitions of non-GAAP monetary measures, the non-GAAP monetary measures as utilized by us on this report have limits of their usefulness to traders and could also be calculated in a different way from, and due to this fact might not be instantly similar to equally titled measures utilized by different corporations.

The next desk reconciles our monetary measures for internet revenue (loss) and internet revenue (loss) per share (“EPS”) for diluted weighted common shares as reported in our condensed consolidated statements of operations to a non-GAAP presentation.

           
  Three Months     9 Months  
  Ended September 30,     Ended September 30,  
  2024     2023     2024     2023  
  Internet Earnings     Primary EPS     Internet Earnings     Primary EPS     Internet Earnings     Primary EPS     Internet Loss     Primary EPS  
  (In hundreds besides per share knowledge)  
GAAP reported internet revenue (loss) $ 11,550     $ 0.04     $ 1,721     $ 0.01     $ 20,166     $ 0.07     $ (13,339 )   $ (0.05 )
Non-GAAP changes:                                              
Bought portion of royalty income(1)   (2,708 )     (0.01 )                 (7,533 )     (0.03 )            
Curiosity expense on legal responsibility on the market of future royalties   4,089       0.02                   12,720       0.04              
Inventory compensation   5,227       0.02       4,601       0.02       15,540       0.06       13,836       0.05  
Loss (achieve) on international forex transaction   2,454       0.01       (2,065 )     (0.01 )     526             (860 )      
Achieve on discount buy   (5,259 )     (0.02 )                 (5,259 )     (0.02 )            
Loss on extinguishment of debt                           7,050       0.03              
Loss (achieve) on available-for-sale securities                           1,550       0.01       (932 )      
Non-GAAP adjusted internet revenue (loss) $ 15,353     $ 0.06     $ 4,257     $ 0.02     $ 44,760     $ 0.16     $ (1,295 )   $ (0.00 )
Weighted common shares used to compute internet revenue (loss) per share – primary   274,998             268,732             272,811             266,126        

__________________________
(1) Represents the non-cash portion of the 1% royalty on internet gross sales of Tyvaso DPI earned through the durations offered which is remitted to the royalty purchaser and acknowledged as royalties – collaboration in our consolidated statements of operations. Our revenues from royalties – collaboration throughout 3Q 2024 and the 9 months ended September 30, 2024 totaled $27.1 million and $75.3 million, respectively, of which $2.7 million and $7.5 million, respectively, had been attributed to the royalty purchaser.

Scientific Improvement Replace and Anticipated Milestones

Afrezza INHALE-3 (T1D, Afrezza vs. normal of care a number of each day injections or pumps) Part 4 medical trial

  • High-level 30-week outcomes demonstrated that switching to or remaining on Afrezza allowed practically twice as many individuals to get to the A1C (<7%) aim through the extension interval
  • Extra knowledge to be offered at Superior Applied sciences and Therapies for Diabetes (ATTD) and different conferences in 1H 2025

Afrezza INHALE-1 Pediatric Part 3 medical trial

  • Major endpoint evaluation outcomes anticipated in 4Q 2024
  • Six-month knowledge with security extension anticipated in 1H 2025
  • FDA submission for label growth deliberate in 2025

MNKD-101 (Clofazimine Inhalation Suspension) Part 3 (ICoN-1) medical trial

  • Trial cleared to proceed in 4 international locations (U.S., Japan, South Korea and Australia) with a fifth (Taiwan) anticipated in 4Q 2024
  • First affected person randomized within the US in 3Q
  • Roughly 230 members to be randomized at 100+ websites for at least 180 evaluable members

MNKD-201 (nintedanib DPI) Part 1 medical trial

  • Trial efficiently accomplished, major goal met demonstrating optimistic security outcomes and was well-tolerated in wholesome volunteers
  • Contributors didn’t expertise adversarial occasions sometimes reported with oral nintedanib
  • Preclinical persistent toxicology didn’t present any adversarial findings
  • FDA Finish-of-Part 1 assembly anticipated in 1H 2025

Convention Name

MannKind will host a convention name and presentation webcast to debate these outcomes right this moment at 4:30 p.m. Japanese Time. The webcast will likely be accessible through a hyperlink on MannKind’s web site. A replay can even be obtainable in the identical location inside 24 hours after the decision and accessible for roughly 90 days.

About MannKind

MannKind Company MNKD focuses on the event and commercialization of progressive inhaled therapeutic merchandise and gadgets to handle critical unmet medical wants for these residing with endocrine and orphan lung ailments.

We’re dedicated to utilizing our formulation capabilities and machine engineering prowess to reduce the burden of ailments reminiscent of diabetes, nontuberculous mycobacterial (NTM) lung illness, pulmonary fibrosis, and pulmonary hypertension. Our signature applied sciences – dry-powder formulations and inhalation gadgets – supply speedy and handy supply of medicines to the deep lung the place they will exert an impact domestically or enter the systemic circulation, relying on the goal indication.

With a passionate group of Mannitarians collaborating nationwide, we’re on a mission to offer individuals management of their well being and the liberty to dwell life.

Please go to mannkindcorp.com to study extra, and comply with us on LinkedIn, Facebook, X or Instagram.

Ahead-Trying Statements

Statements on this press launch that aren’t statements of historic truth are forward-looking statements that contain dangers and uncertainties. These statements embody, with out limitation, statements concerning the anticipated timing of affected person enrollment and world growth in a medical research of MNKD-101; the anticipated timing for knowledge read-outs from medical research of Afrezza; timing for an end-of-Part 1 assembly with the FDA for MNKD-201; and the timing of a deliberate FDA submission for Afrezza. Phrases reminiscent of “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “aim,” “potential” and comparable expressions are meant to establish forward-looking statements. These forward-looking statements are based mostly upon MannKind’s present expectations. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements on account of numerous dangers and uncertainties, which embody, with out limitation, dangers related to growing product candidates; dangers and uncertainties associated to unexpected delays which will affect the timing of medical trials and reporting knowledge; dangers related to security and different problems of our merchandise and product candidates; dangers related to the regulatory overview course of; and different dangers detailed in MannKind’s filings with the Securities and Change Fee (“SEC”), together with underneath the “Threat Components” heading of its Annual Report on Type 10-Okay for the 12 months ended December 31, 2023, filed with the SEC on February 27, 2024, and subsequent periodic studies on Type 10-Q. You’re cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date of this press launch. All forward-looking statements are certified of their entirety by this cautionary assertion, and MannKind undertakes no obligation to revise or replace any forward-looking statements to mirror occasions or circumstances after the date of this press launch.

Tyvaso DPI is a trademark of United Therapeutics Company.

AFREZZA, MANNKIND, and V-GO are registered emblems of MannKind Company.

 
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
             
    Three Months
Ended September 30,
    9 Months
Ended September 30,
 
    2024     2023     2024     2023  
    (In hundreds besides per share knowledge)  
Revenues:                        
Internet income – business product gross sales   $ 19,728     $ 17,927     $ 59,272     $ 53,834  
Income – collaborations and companies     23,268       13,108       74,130       35,705  
Royalties – collaboration     27,083       20,218       75,326       50,951  
Whole revenues     70,079       51,253       208,728       140,490  
Bills:                        
Value of products offered     3,197       3,995       12,621       14,749  
Value of income – collaborations and companies     14,826       10,259       44,377       29,955  
Analysis and improvement     12,926       9,989       34,755       22,047  
Promoting     13,093       13,440       36,189       40,752  
Normal and administrative     10,823       10,538       34,168       33,027  
Loss (achieve) on international forex transaction     2,454       (2,065 )     526       (860 )
Whole bills     57,319       46,156       162,636       139,670  
Earnings from operations     12,760       5,097       46,092       820  
Different revenue (expense):                        
Curiosity revenue, internet     3,179       1,580       9,790       4,429  
Curiosity expense on legal responsibility on the market of future royalties     (4,089 )           (12,720 )      
Curiosity expense on financing legal responsibility     (2,470 )     (2,459 )     (7,361 )     (7,332 )
Curiosity expense     (1,801 )     (2,815 )     (10,419 )     (12,474 )
Achieve on discount buy     5,259             5,259        
Different revenue     32       318       32       286  
Loss on extinguishment of debt                 (7,050 )      
(Loss) achieve on available-for-sale securities                 (1,550 )     932  
Whole different expense     110       (3,376 )     (24,019 )     (14,159 )
Earnings (loss) earlier than revenue tax expense     12,870       1,721       22,073       (13,339 )
Earnings tax expense     1,320             1,907        
Internet revenue (loss)   $ 11,550     $ 1,721     $ 20,166     $ (13,339 )
Internet revenue (loss) per share – primary   $ 0.04     $ 0.01     $ 0.07     $ (0.05 )
Weighted common shares used to compute internet revenue (loss) per share – primary     274,998       268,732       272,811       266,126  
Internet revenue (loss) per share – diluted   $ 0.04     $ 0.01     $ 0.07     $ (0.05 )
Weighted common shares used to compute internet revenue (loss) per share – diluted     284,693   (1)   323,770   (1)   281,407   (1)   266,126  

__________________________

(1) Diluted weighted common shares (“DWAS”) differs from primary as a result of weighted common variety of shares that will be excellent upon train or vesting of excellent share-based funds to workers and conversion of convertible notes. For the three and 9 months ended September 30, 2024 DWAS included and 9,695 and eight,596, respectively, shares of excellent share-based funds. 44,120 shares issuable upon conversion of our Senior convertible notes had been excluded as their impact can be antidilutive. For the three months ended September 30, 2023 DWAS included 7,548 shares of excellent share-based funds, 44,120 shares issuable upon conversion of our Senior convertible notes, and three,370 shares issuable upon conversion of our Mann Group convertible word.

 
MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
             
    September 30, 2024     December 31, 2023  
    (In hundreds besides share
and per share knowledge)
 
ASSETS            
Present property:            
Money and money equivalents   $ 62,373     $ 238,480  
Quick-term investments     189,215       56,619  
Accounts receivable, internet     18,184       14,901  
Stock     26,663       28,545  
Pay as you go bills and different present property     31,229       34,848  
Whole present property     327,664       373,393  
Restricted money     735        
Lengthy-term investments     16,796       7,155  
Property and gear, internet     85,339       84,220  
Goodwill     1,931       1,931  
Different intangible property     5,313       1,073  
Different property     26,422       7,426  
Whole property   $ 464,200     $ 475,198  
             
LIABILITIES AND STOCKHOLDERS’ DEFICIT            
Present liabilities:            
Accounts payable   $ 6,444     $ 9,580  
Accrued bills and different present liabilities     37,386       42,036  
Legal responsibility on the market of future royalties – present     11,755       9,756  
Financing legal responsibility – present     9,998       9,809  
Deferred income – present     6,518       9,085  
Acknowledged loss on buy commitments – present           3,859  
Midcap credit score facility – present           20,000  
Whole present liabilities     72,101       104,125  
Senior convertible notes     227,941       226,851  
Legal responsibility on the market of future royalties – long run     137,140       136,054  
Financing legal responsibility – long run     94,005       94,319  
Deferred income – long run     65,150       69,794  
Acknowledged loss on buy commitments – long run     62,638       60,942  
Working lease legal responsibility     12,167       3,925  
Milestone liabilities     2,813       3,452  
Financing lease legal responsibility     171        
Midcap credit score facility – long run           13,019  
Mann Group convertible word           8,829  
Accrued curiosity – Mann Group convertible word           56  
Whole liabilities     674,126       721,366  
Stockholders’ deficit:            
Undesignated most popular inventory, $0.01 par worth – 10,000,000 shares licensed; no shares issued or excellent as of September 30, 2024 or December 31, 2023            
Widespread inventory, $0.01 par worth – 800,000,000 shares licensed; 275,775,038 and 270,034,495 shares issued and excellent as of September 30, 2024 and December 31, 2023, respectively     2,753       2,700  
Extra paid-in capital     2,995,974       2,980,539  
Amassed different complete revenue     588        
Amassed deficit     (3,209,241 )     (3,229,407 )
Whole stockholders’ deficit     (209,926 )     (246,168 )
Whole liabilities and stockholders’ deficit   $ 464,200     $ 475,198  
                 

MannKind Contacts:
Investor Relations
Ana Kapor
(818) 661-5000
Electronic mail: [email protected]

Media Relations
Christie Iacangelo
(818) 292-3500
Electronic mail: [email protected]

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