What exactly is the Technosphere® Platform?

One of the largest organs in your body are the lungs. Picture the size of a full tennis court and that is roughly the surface area of both lungs in a typical adult. Running through those lungs are airways whose total length measures 1,500 miles – that’s the distance between Chicago and Las Vegas, New York to Albuquerque, and Los Angeles to Nashville.

Simply put, the lungs create a wonderful platform for effective drug delivery. MannKind’s Technosphere technology recognizes this and provides the distinct advantage of rapid, deep lung drug delivery. The effect is similar to intravenous delivery (I.V.; within a vein) and has the added benefit of bypassing the liver which can be especially helpful in reducing systemic side effects.

Examining it closer, it helps to look at inhalation, air flow travel, and the exhale. When you breathe in, air is drawn into the lung and flows down curving, narrowing airways that end in the air sacs or alveoli. When air is exhaled, the flow is reversed. Between the end of an inhalation and the start of exhalation, the air in the lung is stationary. To reach the deep lung, inhaled particles must be carried by the air stream and have enough momentum to continue through the stationary air to collide with the lung surface.

Particles that can reach the lung have aerodynamic diameters between 0.5 µm and 5-6 µm (1 µm is 1 micro-meter or about 0.00004 inches). Particles that are larger than 6 µm will leave the air stream and hit the back of your mouth and throat; smaller than 0.5 µm wouldn’t have the ability to reach the lungs and would simply get exhaled.

“The average Technosphere particle is about 2-2.5 µm which is in the middle of the respirable range,” explains Marshall Grant, PhD, MSc, Executive Director, Clinical Pharmacology & Research for MannKind Corporation. “The particle size distribution is a major reason Technosphere powders are highly efficient in delivering drug to the lungs than other dry powder inhalers (DPIs).”

The Technosphere particles in FDA-approved Afrezza® (insulin human) Inhalation Powder and Tyvaso DPI™ (treprostinil) Inhalation Powder are manufactured by different processes and possess different characteristics. But both are made up of small crystals of FDKP (fumaryl diketopiperazine), MannKind’s proprietary molecule. FDKP provides high solubility and fast dissolution at physiologic pH – and more importantly – can crystallize and form particles in the range appropriate for optimum delivery to the lungs.

When Technosphere powder reaches the lung surface, the FDKP and drug dissolve. The FDKP is then rapidly cleared from the lung into systemic circulation. The FDKP is not metabolized, but rather excreted primarily in the urine. Another value of Technosphere powders has been their versatility – they are compatible with a wide range of doses with different types of drugs.

MannKind’s Technosphere powders are delivered into the lung’s airstream via an inhalation device or DPI (dry powder inhaler). The breath-powered inhalers (Dreamboat® being the most common version) provide excellent delivery efficiency and are proven to deliver up to 70% of the dry-powder dose deep into the lungs. Our DPI are designed to be simple, easy to use and discreet. For patients, imagine having a drug in the convenient form of an inhaler that fits in the palm of your hand. This approach allows patients to not only take control of their health but do it while going about their day and enjoying life more humann.

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NTM Lung Disease on the Rise

“I cough every morning upon waking, so I don’t feel rested.” “Imagine not being able to breathe.” “Anxiety ruins everything about you – it’s not a normal life.” “You just exist from day to day and week to week.” These are a sampling of comments about the most bothersome symptoms from living with Nontuberculous Mycobacteria (NTM) shared in a study from NTM Info & Research, Inc. The statements are unfortunately typical and those with NTM often have unpredictable day-to-day health functioning and reduced quality of life.

NTM lung disease is a serious infection that is caused by bacteria that are common in the environment and can cause lung damage. The reality is that we are all exposed to these bacteria in our day-to-day lives – more than 120 species of mycobacteria have been identified. These common bacteria exist in water and soil particles that are in the air, wet places like hot tubs, steamy bathrooms, dishwashers, and even the dewy ground we walk on at the park. But not everyone is at risk of getting NTM lung disease just because they are exposed.

Those predisposed often have underlying conditions such as asthma, COPD, and bronchiectasis, which makes them prone to NTM infection. NTM is not considered to be contagious. Women over the age of 65 make up the majority of those impacted, with a predominance in those of Caucasian and Asian descent.

A rare disease, NTM can often be difficult to diagnose. Many will experience coughing, fatigue, weight loss and shortness of breath – all of which are common with other lung disease symptoms and other conditions like tuberculosis. With NTM, symptoms often worsen, and that is a marker not to be ignored.

It is estimated that some 86,000 individuals are living with NTM lung diseases, and it is on the rise growing 8% each year. Coastal regions including Gulf States have higher rates of infection accounting for 70% of annual NTM cases.

While no cure is available, treatments to manage NTM are available. Treatment for NTM involves antibiotic and multidrug regimens with duration lasting from months to years with tolerability and adverse reactions to treatment which often leads to a lack of adherence to therapy.

There is a valuable need to develop medicines that are well tolerated and effective that lends to consistent patient use and alleviates symptoms of NTM lung disease. MannKind continues to progress MNKD-101 (Clofazimine) for the treatment of NTM.

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Release Details

CORRECTION -- MannKind Corporation Reports 2023 First Quarter Financial Results

05/09/23
PDF Version
Conference Call to Begin Today at 5:00 p.m. (ET)

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by MannKind Corporation (Nasdaq: MKND), please note in the second table, titled "CONDENSED CONSOLIDATED BALANCE SHEETS", the right column header was incorrectly labeled as "March 31, 2022", when it should be labeled "December 31, 2022". The corrected release follows:

  • 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

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,
    
December 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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Source: MannKind