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 2018 Second Quarter Financial Results Conference Call to Begin Today at 5:00 PM ET

08/02/18
PDF Version
  • 2Q 2018 Afrezza Net Revenue was $3.8 million; 142% growth versus 2Q 2017
  • 2Q 2018 Afrezza TRx grew 71% versus 2Q 2017
  • Debt principal reduced by $42.6 million, or 27%, year-to-date
  • Successfully completed Phase 1 clinical trial of Treprostinil Technosphere
  • Executed exclusive marketing and distribution agreement with Cipla for Afrezza in India
  • Presented novel STAT study and AFFINITY-1 hypoglycemia data at ADA 78th Scientific Sessions

WESTLAKE VILLAGE, Calif., Aug. 02, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation(NASDAQ:MNKD) today reported financial results for the second quarter ended June 30, 2018.

“In 2Q 2018, we experienced our highest Afrezza sales ever due to increased physician trial and adoption. We have doubled our market share over the past year as a result of our commercialization efforts and are excited about our new Afrezza clinical data being released throughout 2018.  Additionally, Treprostinil Technosphere (TreT) continues to progress towards Phase 3 and may address an important unmet need for those living with pulmonary arterial hypertension,”said Michael Castagna, Chief Executive Officer of MannKind Corporation.

Second Quarter Results

For the second quarter of 2018, Afrezza net revenue was $3.8 million, an increase of 142% compared to $1.5 million for the second quarter of 2017 resulting from increased volume, price, and favorable cartridge mix.  On January 1, 2018, we adopted ASC 606, the new revenue recognition standard, under which we recognize revenue as we sell product to wholesale distributors; revenue for prior periods is recognized on the basis of a model that estimates the sale of Afrezza to patients.

Cost of goods sold remained level for the three months ended June 30, 2018 at $5.0 million compared to the same period in 2017. Lower inventory write-offs offset an increase in cost of goods sold resulting from higher Afrezza sales and excess capacity costs.

Research and development (R&D) expenses for the second quarter of 2018 were $2.9 million compared to $3.1 million for the second quarter of 2017, a decrease of $0.2 million or 5%, reflecting $0.7 million in lower salary related expenses for personnel who were engaged in research and development activities in 2017 who have transitioned to Afrezza medical affairs activities and a $0.3 million decrease in repairs and maintenance on laboratory equipment, offset by a $0.9 million increase in clinical trial costs.

Selling, general and administrative (SG&A) expenses were $21.7 million for the second quarter of 2018 compared to $18.6 million for the second quarter of 2017.  The $3.1 million, or 17%, increase was primarily due to a $1.0 million increase in non-cash stock compensation expenses, a $0.8 million increase in consulting fees, a $0.6 million increase in costs related to transitioning certain corporate support functions from Connecticut to our corporate headquarters in California, and a $0.6 million increase in relocation spending for key personnel.

The net loss for the second quarter of 2018 was $22.7 million, or $0.16 per share, compared to the $35.3 million net loss in the second quarter of 2017 or $0.35 per share.

Six Months Ended Results

For the six months ended June 30, 2018, Afrezza net revenue was $7.2 million, an increase of 161% compared to $2.7 million for the same period in 2017 (prior to the adoption of ASC 606).

Cost of goods sold for the six months ended June 30, 2018 was $9.1 million compared to $7.6 million for the six months ended June 30, 2017, an increase of $1.5 million or 19%. This increase was due to the result of higher Afrezza sales of $0.8 million and $1.0 million increase of excess capacity costs. These increases were partially offset by lower inventory write-offs compared to the same period in 2017.

R&D expenses for the six months ended June 30, 2018 were $5.6 million compared to $6.3 million for the six months ended June 30, 2017, a decrease of $0.7 million or 11%, reflecting $0.9 million in lower salary related expenses for personnel who were engaged in research and development activities in 2017 but transitioned to Afrezza medical affairs activities, offset by a $0.3 million increase in clinical trial costs.

SG&A expenses were $42.3 million for the six months ended June 30, 2018 compared to $34.0 million for the six months ended 2017.  The $8.3 million or 24% increase was primarily due to a $1.7 million increase in additional headcount-related expenses associated with sales personnel hired in 2018, a $1.1 million increase in additional headcount-related expenses in our human resources, accounting, corporate communications, and office support departments, a $1.7 million increase in non-cash stock compensation expense, a $1.3 million increase in employee benefits, a $1.2 million increase in costs related to transitioning certain corporate support functions from Connecticut to our corporate headquarters in California, and a $0.9 million increase in consulting fees.

The net loss for the six months ended June 30, 2018 was $53.1 million, or $0.41 per share, compared to a $51.7 million for the six months ended June 30, 2017, or $0.53 per share.

Cash and Cash Equivalents

Cash, cash equivalents and restricted cash at June 30, 2018 decreased to $26.7 million compared to $48.4 million at December 31, 2017, primarily due to net cash used in operating activities of $48.8 million in 2018 primarily offset by $26.4 million of net proceeds from a registered direct offering of 14 million shares of common stock and warrants at a purchase price of $2.00 per share and accompanying warrant.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. To view and listen to the earnings call webcast live via the Internet, visit the Company's website at www.mannkindcorp.com and click on the “Q2 2018 MannKind Earnings Conference Call” link in the Webcasts section of News & Events.  To participate in the live call by telephone, please dial (800) 239-9838 toll-free or (323) 794-2551 toll/international and use the conference passcode: 5195402.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll-free or (412) 317-6671 toll/international and use the replay passcode: 5195402.  A replay will also 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 diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company’s first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide.  MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing 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, 2017 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.

MANNKIND CORPORATION AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
 
    Three Months Ended June 30,     Six Months Ended June 30,  
    2018     2017     2018     2017  
Revenues:                                
Net revenue - commercial product sales   $ 3,753     $ 1,548     $ 7,155     $ 2,745  
Net revenue - collaboration     87       63       150       125  
Revenue - other     53       552       53       2,302  
Total revenues     3,893       2,163       7,358       5,172  
Expenses:                                
Cost of goods sold     5,095       5,086       9,103       7,635  
Research and development     2,967       3,123       5,611       6,251  
Selling, general and administrative     21,731       18,566       42,349       33,956  
Property and equipment impairment     —       111       —       111  
(Gain) Loss on foreign currency translation     (5,363 )     6,848       (2,379 )     8,392  
Total expenses     24,430       33,734       54,684       56,345  
Loss from operations     (20,537 )     (31,571 )     (47,326 )     (51,173 )
Other (expense) income:                                
Change in fair value of warrant liability     —       147       —       6,776  
Interest income     55       58       161       114  
Interest expense on notes     (1,709 )     (2,422 )     (3,503 )     (5,128 )
Interest expense on note payable to related party     (1,046 )     (721 )     (2,160 )     (1,435 )
Gain (Loss) on extinguishment of debt     772       (830 )     (53 )     (830 )
Other income     30       —       61       13  
Total other (expense)     (1,898 )     (3,768 )     (5,494 )     (490 )
Loss before provision for income taxes     (22,435 )     (35,339 )     (52,820 )     (51,663 )
Income tax expense     (240 )     —       (240 )     —  
Net loss   $ (22,675 )   $ (35,339 )   $ (53,060 )   $ (51,663 )
Net loss per share - basic and diluted   $ (0.16 )   $ (0.35 )   $ (0.41 )   $ (0.53 )
Shares used to compute basic and diluted net loss per share     140,054       99,864       130,535       97,816  





MANNKIND CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(In thousands)
                 
    As of June 30, 2018     As of December 31, 2017  
ASSETS                
Current assets:                
Cash and cash equivalents   $ 26,178     $ 43,946  
Restricted cash     527       4,409  
Accounts receivable, net     2,848       2,789  
Inventory     3,676       2,657  
Deferred costs from commercial product sales     —       405  
Prepaid expenses and other current assets     2,570       3,010  
Total current assets     35,799       57,216  
Property and equipment, net     26,036       26,922  
Other assets     320       437  
Total assets   $ 62,155     $ 84,575  
                 
LIABILITIES AND STOCKHOLDERS' DEFICIT                
Current liabilities:                
Accounts payable   $ 9,237     $ 6,984  
Accrued expenses and other current liabilities     14,075       12,449  
Facility financing obligation     38,002       52,745  
Deferred revenue, net     —       3,038  
Deferred payments from collaboration - current     396       250  
Recognized loss on purchase commitments - current     13,191       12,131  
Total current liabilities     74,901       87,597  
Note payable to related party     72,196       79,666  
Accrued interest - note payable to related party     4,566       2,347  
Senior convertible notes     19,161       24,411  
Recognized loss on purchase commitments - long term     88,346       97,585  
Deferred payments from collaboration - long term     2,403       500  
Milestone rights liability     7,201       7,201  
Total liabilities     268,774       299,307  
Commitments and contingencies                
Stockholders' deficit:                
Undesignated preferred stock, $0.01 par value - 10,000,000 shares authorized; no shares issued or outstanding at June 30, 2018 and December 31, 2017     —       —  
Common stock, $0.01 par value - 280,000,000 shares authorized, 145,619,293 and 119,053,414 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively     1,456       1,192  
Additional paid-in capital     2,698,028       2,638,992  
Accumulated other comprehensive loss     (18 )     (18 )
Accumulated deficit     (2,906,085 )     (2,854,898 )
Total stockholders' deficit     (206,619 )     (214,732 )
Total liabilities and stockholders' deficit   $ 62,155     $ 84,575  

Company Contact:
Rose Alinaya
SVP, Investor Relations and Treasury
818-661-5000
ir@mannkindcorp.com

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Source: MannKind