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 2016 Third Quarter Financial Results

11/09/16
PDF Version

VALENCIA, Calif., Nov. 09, 2016 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) today reported financial results for the three and nine months ended September 30, 2016.

For the three and nine months ended September 30, 2016, we recognized $161.8 million in net revenue from our collaboration with Sanofi. This amount relates to activities from prior periods previously deferred. In the third quarter of 2016, due to the termination of the Sanofi license agreement, the remaining costs under the Sanofi License Agreement were fixed or determinable and future activity under the Sanofi Supply Agreement was reasonably estimable, which allowed for the recognition of revenue from collaboration this quarter. There are no future obligations to Sanofi.  The amount of net revenue - collaboration recognized in the three and nine months ended September 30, 2016 consists of the upfront payment of $150.0 million and milestone payments of $50.0 million, net of $64.8 million of net loss share with Sanofi, as well as $17.4 million in sales of Afrezza and $9.2 million in sales of raw insulin, both to Sanofi.

We began distributing MannKind branded Afrezza products to wholesalers during the week of July 25, 2016.  For the three and nine months ended September 30, 2016, net revenue from commercial product sales represents $0.6 million of net sales of Afrezza dispensed to patients.  In addition, as of September 30, 2016, we recorded $2.0 million in deferred revenue, of which $1.6 million is net of estimated gross-to-net adjustments and represents product shipped to our third-party logistics provider and wholesale distributors, but not dispensed to patients as of that date.  Estimated gross-to-net adjustments for the third quarter of 2016 were approximately 32%, which includes estimates of wholesaler distribution and logistics fees, prompt pay discounts, estimated government rebates and patient discount programs.  Deferred revenue also includes $0.4 million that we have received for the sale of surplus raw materials to a third party, where delivery was made after September 30, 2016.

For the three and nine months ended September 30, 2016, we recognized $22.7 million of product costs — collaboration which was previously deferred and consisted of $13.5 million in Afrezza manufacturing costs for product sold to Sanofi and $9.2 million for a change in estimate in our recognized loss on purchase commitments related to the sale of raw insulin to Sanofi.

Cost of goods sold was approximately $4.3 million for the third quarter of 2016, a decrease of 47% from the third quarter of 2015.  This decrease is primarily due to a decrease in under-absorbed labor and overhead due to decreased depreciation as a result of the fixed asset impairment write-down in 2015 and decreased salaries resulting from the reduction in force in 2015 as well as a gain on purchase commitments for other material related to a change in estimate associated with the renegotiation of certain agreements and a reduction in inventory write-offs offset by a foreign currency exchange loss on recognized loss on purchase commitments for insulin purchases.  Cost of goods sold was $15.6 million for the nine months ended September 30, 2016, and included under-absorbed labor and overhead costs expensed in the period, and a foreign currency exchange loss on the recognized loss on purchase commitments for insulin offset by a gain on purchase commitments for other materials related to a change in estimate associated with the renegotiation of certain agreements. Cost of goods sold for the three and nine months ended September 30, 2016 also includes $0.1 million attributable to commercial product sales, which consists of the manufacturing costs for Afrezza dispensed to patients. This $0.1 million attributable to commercial product sales only includes conversion cost as we wrote off the cost of our raw materials held in inventory at the end of 2015.

During the three and nine months ended September 30, 2015, the Company did not recognize any net revenue or product costs — collaboration or net revenue — commercial product sales.

Research and development expenses were $3.9 million for the third quarter of 2016, a decrease of 38% from the third quarter of 2015, primarily due to expense associated with the 2015 reduction in force exceeding the expense associated with the 2016 reduction in force along with curtailing certain research and development projects and facility spending offset by an increase in development work done for third parties.  Research and development expenses were $13.4 million for the nine months ended September 30, 2016, a decrease of 43% compared to the same period in 2015, primarily due to expense associated with the 2015 reduction in force exceeding the expense associated with the 2016 reduction in force along with a decrease in research and development projects and facility spending offset by an increase in development work done for third parties and tax credits.

Selling, general and administrative expenses were approximately $13.1 million for the third quarter of 2016, an increase of 14% from the third quarter of 2015, mainly due to increased costs for the support of sales and marketing of Afrezza offset by a decrease in general and administrative expenses due to the reduction in force in 2015.  Selling, general and administrative expenses for the nine months ended September 30, 2016 were $31.6 million, a decrease of 3% from the same period in 2015, primarily due to the 2015 reduction in force, lower communication, facility and insurance costs and lower stock-based compensation expense in general and administrative expenses offset by increased costs for the support of sales and marketing of Afrezza in selling expenses.

Included in the three months ended September 30, 2016 is a $13.2 million benefit from a decrease in the fair value of the warrant liability from June 30, 2016.  Included in the nine months ended September 30, 2016 is a $7.9 million benefit from a decrease in the fair value of the warrant liability from May 12, 2016, the date the warrants were issued.

The net income for the three and nine months ended September 30, 2016 was $126.5 million and $71.7 million, or basic net income of $0.26 and $0.16 per share, based on 478.1 and 454.2 million weighted average shares outstanding, compared with a net loss of $31.9 million and $91.4 million for the same periods in 2015, or basic net loss of $0.08 and $0.23 per share, based on 405.2 and 401.7 million weighted average shares outstanding. The number of common shares outstanding at September 30, 2016 was 478.4 million.

Cash and cash equivalents at September 30, 2016 were $35.5 million, compared to $59.1 million at December 31, 2015. Currently, $30.1 million remains available for borrowing under the amended loan arrangement with The Mann Group along with $50.0 million available under the at-the-market facility.

Conference Call and Presentation Webcast

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 webcast, visit MannKind's website at http://www.mannkindcorp.com and click on the "Q3 2016 MannKind Earnings Conference Call" link in the Webcast section of News & Events.  To participate in the live call by telephone, please dial (888) 771-4371 or (847) 585-4405 and use the participant passcode: 41477573.

A telephone replay will be accessible for approximately 14 days following completion of the call by dialing (888) 843-7419 or (630) 652-3042 and use the participant passcode: 4147 7573#.  A replay will also be available on MannKind's website for 14 days.

About MannKind Corporation

MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.

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, 2015 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 par value and share data)
 
  Three Months Ended
September 30,		 Nine Months Ended
September 30,
   2016   2015   2016   2015 
Revenue:        
Net revenue - collaboration $  161,781  $  -   $  161,781  $  -  
Net revenue - commercial product sales    573     -      573     -  
Total net revenue    162,354     -      162,354     -  
Expense:        
Product costs - collaboration    22,742     -      22,742     -  
Cost of goods sold    4,331     8,115     15,567     15,688 
Research and development    3,917     6,341     13,357     23,455 
Selling, general and administrative    13,135     11,547     31,595     32,649 
Total expenses    44,125     26,003     83,261     71,792 
Income (loss) from operations  118,229   (26,003)  79,093   (71,792)
Change in fair value of warrant liability    13,185     -      7,879     -  
Interest income    28   2     70   8 
Interest expense on notes    (4,166)  (4,145)    (12,567)  (17,899)
Interest expense on note payable to our principal stockholder     (729)  (729)    (2,172)  (2,164)
Loss on extinguishment of debt    -    (1,049)    -    (1,049)
Other (expense) income    (27)  67     (613)  1,470 
Net income (loss) $  126,520  $  (31,857)  71,690   (91,426)
         
Net income (loss) per share - basic $  0.26  $  (0.08) $  0.16  $  (0.23)
         
Net income (loss) per share - diluted $  0.26  $  (0.08) $  0.16  $  (0.23)
         
Shares used to compute basic net income (loss) per share  478,137   405,199   454,188   401,734 
         
Shares used to compute diluted net income (loss) per share  482,744   405,199   454,366   401,734 
 


MannKind Corporation and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except par value and share data)
 
  September 30,
2016		 December 31,
2015
     
ASSETS    
Current assets:    
Cash and cash equivalents $  35,530  $  59,074 
Accounts receivable    3,137     23 
Inventory    5,124     -  
Deferred costs from collaboration    -      13,539 
Deferred costs from commercial product sales    279     -  
Prepaid expenses and other current assets    4,534     4,018 
Total current assets    48,604     76,654 
Property and equipment - net    46,825     48,749 
Other assets    702     1,009 
Total assets $  96,131  $  126,412 
     
LIABILITIES AND STOCKHOLDERS' DEFICIT    
Current liabilities:    
Accounts payable $  5,093  $  15,599 
Accrued expenses and other current liabilities    14,164     7,929 
Facility financing obligation    70,888     74,582 
Deferred sales from collaboration    -      17,503 
Deferred payments from collaboration    462     140,231 
Deferred revenue    2,014     -  
Recognized loss on purchase commitments - current    8,340     12,475 
Warrant liability    4,871     -  
Total current liabilities    105,832     268,319 
Note payable to our principal stockholder    49,521     49,521 
Sanofi loan facility and loss share obligation    71,210     62,371 
Senior convertible notes - long term    27,629     27,613 
Recognized loss on purchase commitments - long term    63,229     53,692 
Other liabilities    17,397     15,225 
Total liabilities    334,818     476,741 
     
Stockholders' deficit    (238,687)    (350,329)
Total liabilities and stockholders' deficit $  96,131  $  126,412 


Company Contact:
Rose Alinaya
SVP, Finance
661-775-5300
ralinaya@mannkindcorp.com