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

MannKind Corporation Reports 2021 First Quarter Financial Results

05/12/21
PDF Version

Conference Call to Begin Today at 5:00 PM ET

  • 1Q 2021 Total Revenues of $17.4 million; +7% vs. 1Q 2020
  • Received $230.0 million gross proceeds from 2.5% senior convertible notes
  • $278.3 million of Cash, Cash Equivalents and Investments at March 31, 2021
  • Tyvaso DPI™ NDA submitted to the FDA by collaboration partner United Therapeutics

WESTLAKE VILLAGE, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today reported financial results for the quarter ended March 31, 2021.

“We started 2021 by taking advantage of favorable market conditions to strengthen our financial position with the issuance of $230 million of senior convertible notes, which provides our current and future partners with greater confidence in our company,” said Michael Castagna, Chief Executive Officer of MannKind Corporation. “The capital raised allows us to reduce our legacy debt, advance our pipeline and grow Afrezza. In the first quarter of 2021, the underlying demand for paid Afrezza prescriptions grew in the mid-single digits year over year.”

Total revenues were $17.4 million for the first quarter of 2021, an increase of $1.2 million, or 7%, reflecting Afrezza net revenue of $8.1 million and collaboration and services revenue of $9.3 million. Afrezza net revenue increased 1% compared to $8.0 million in the first quarter of 2020. Collaboration and services revenue for the first quarter of 2021 increased $1.1 million compared to the first quarter of 2020, primarily due to additional pass-through costs associated with the UT license agreement and the launch of the Vista Pharma Co-promotion Agreement for Thyquidity. 

Afrezza gross profit for each of the first quarters of 2021 and 2020 was $3.8 million. Cost of goods sold increased by $0.2 million compared to the same period in 2020, which was offset by the increase in net revenues discussed above. Gross margin in the first quarter of 2021 was 47% compared to 48% for the same period in 2020.

Research and development expenses for the first quarter of 2021 were $2.4 million compared to $1.8 million for the first quarter of 2020. This increase of $0.7 million, or 39%, was attributable to personnel costs primarily related to increased headcount for research and development, regulatory and medical affairs.

Selling, general and administrative expenses for the first quarter of 2021 were $17.4 million compared to $14.4 million for the first quarter of 2020. This increase of $3.1 million, or 21%, was primarily due to a $2.3 million increase in personnel costs primarily related to increased headcount for our Afrezza commercial team, $0.3 million in patient support services and $0.3 million in promotional and marketing activities.  

For the first quarter of 2021, the gain on foreign currency translation for insulin purchase commitments denominated in Euros was $3.8 million compared $1.8 million for the first quarter of 2020. The fluctuation was due to the change in the U.S. dollar to Euro foreign exchange rate. Interest expense on debt for the first quarter of 2021 was $6.5 million compared to $2.3 million for the first quarter of 2020. This increase of $4.1 million was due to a $3.7 million milestone obligation that was achieved during the quarter and interest expense from the senior convertible notes and the MidCap credit facility.  

The net loss for the first quarter of 2021 was $12.9 million, or $0.05 per share, compared to a $9.3 million net loss in the first quarter of 2020, or $0.04 per share. The increased net loss of $3.6 million was primarily due to the increase in interest expense, selling, general and administrative expenses, and research and development expense, all of which were partially offset by an increase in the gain on foreign currency translation.

Cash, cash equivalents, and investments at March 31, 2021 were $278.3 million compared to $67.0 million at December 31, 2020. The increase in cash, cash equivalents and investments was primarily due to the issuance of $230.0 million of 2.5% senior convertible notes.

Debt Reductions Subsequent to March 31, 2021

In April 2021, the Company repaid $35.1 million outstanding principal under the Mann Group non-convertible promissory note plus $4.9 million of accrued and unpaid interest to the Mann Group. In addition, the Company repaid $10.0 million outstanding principal under the MidCap credit facility.

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 www.mannkindcorp.com under Events & Presentations.  A replay will be available on MannKind's website for 14 days.

About MannKind Corporation 

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  Afrezza is also available by prescription in Brazil where it is commercialized by the Company’s partner Biomm SA.  MannKind is headquartered in Westlake Village, California, and has a manufacturing and R&D facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind’s ability to directly commercialize pharmaceutical products. 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 the 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, the ability to generate significant product sales for MannKind, MannKind’s ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. 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 an investigational combination product that is not approved for any use in any country. The Tyvaso DPI tradename is pending final FDA review.

Company Contact:
818-661-5000
ir@mannkindcorp.com

MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share and per share data)

    March 31, 2021     December 31, 2020  
ASSETS                
Current assets:                
Cash and cash equivalents   $ 247,833     $ 67,005  
Restricted cash     158       158  
Short-term investments     28,962       —  
Accounts receivable, net     3,573       4,218  
Inventory     5,050       4,973  
Prepaid expenses and other current assets     2,766       3,122  
Total current assets     288,342       79,476  
Property and equipment, net     26,507       25,867  
Long-term investments     1,480       —  
Other assets     3,053       3,265  
Total assets   $ 319,382     $ 108,608  
                 
LIABILITIES AND STOCKHOLDERS' DEFICIT                
Current liabilities:                
Accounts payable   $ 6,706     $ 5,582  
Accrued expenses and other current liabilities     27,586       19,707  
PPP loan — current     4,670       4,061  
Deferred revenue — current     25,880       33,275  
Recognized loss on purchase commitments — current     8,274       11,080  
Total current liabilities     73,116       73,705  
Senior convertible notes     222,855       —  
MidCap credit facility     49,406       49,335  
Mann Group promissory notes     53,453       63,027  
Accrued interest — Mann Group promissory notes     4,753       4,150  
PPP loan — long term     203       812  
2024 convertible notes     —       5,000  
Recognized loss on purchase commitments — long term     80,797       84,208  
Operating lease liability     869       1,202  
Deferred revenue — long term     1,626       1,662  
Milestone rights liability     5,926       5,926  
Total liabilities     493,004       289,027  
Stockholders' deficit:                
Undesignated preferred stock, $0.01 par value — 10,000,000 shares authorized; no shares issued or outstanding as of March 31, 2021 and December 31, 2020     —       —  
Common stock, $0.01 par value - 400,000,000 shares authorized, 249,072,677 and 242,117,089 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively     2,491       2,421  
Additional paid-in capital     2,885,946       2,866,303  
Accumulated deficit     (3,062,059 )     (3,049,143 )
Total stockholders' deficit     (173,622 )     (180,419 )
Total liabilities and stockholders' deficit   $ 319,382     $ 108,608  
                 

MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)

  Three Months Ended
March 31,		  
  2021     2020  
Revenues:              
Net revenue — commercial product sales $ 8,099     $ 8,000  
Revenue — collaborations and services   9,337       8,235  
Total revenues   17,436       16,235  
Expenses:              
Cost of goods sold   4,315       4,164  
Cost of revenue — collaborations and services   3,295       3,362  
Research and development   2,442       1,755  
Selling, general and administrative   17,413       14,350  
Asset impairment   —       1,521  
Gain on foreign currency translation   (3,838 )     (1,796 )
Total expenses   23,627       23,356  
Loss from operations   (6,191 )     (7,121 )
Other (expense) income:              
Interest income   3       133  
Interest expense on notes   (5,422 )     (1,071 )
Interest expense on Mann Group promissory notes   (1,030 )     (1,259 )
Other expense   (276 )     (4 )
Total other expense   (6,725 )     (2,201 )
Loss before provision for income taxes   (12,916 )     (9,322 )
Provision for income taxes   —       —  
Net loss $ (12,916 )   $ (9,322 )
Net loss per share - basic and diluted $ (0.05 )   $ (0.04 )
Shares used to compute basic and diluted net loss per share   246,631       212,467  
               

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Source: MannKind