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.

picture 1

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.

picture 1

Release Details

MannKind Corporation Reports 2015 Third Quarter Financial Results

11/09/15
PDF Version

VALENCIA, Calif., Nov. 9, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) today reported financial results for the third quarter ended September 30, 2015.

For the three and nine months ended September 30, 2015, product shipments of Afrezza, our novel rapid-acting inhaled insulin therapy, were $4.1 million and $17.1 million, respectively, which we recorded as deferred product sales from our collaboration with Sanofi. For the quarter ended September 30, 2015, our portion of the loss sharing arrangement with Sanofi related to Afrezza was $14.7 million, which we subsequently financed by way of an advance under the loan facility with an affiliate of Sanofi after September 30, 2015. The amount currently outstanding under the Sanofi loan facility is now $43.7 million, which includes $0.8 million in paid-in-kind interest.

For the third quarter of 2015, total operating expenses decreased from $38.3 million to $26.0 million, a decline of 32.1%, compared to the same quarter in 2014, primarily due to Afrezza having moved out of clinical development into the commercial market. Additionally, non-cash stock compensation from the non-recurring achievement of performance and modification events in 2014 decreased in the third quarter of 2015 as compared to the third quarter of 2014. Research and development expenses decreased from $19.2 million to $6.3 million, a decrease of 67.2%, reflecting the transition from development to commercial activities. General and administrative expenses decreased from $19.1 million to $11.5 million, a reduction of 39.8%, mainly due to the decrease in non-cash stock compensation expense. Offsetting the total decrease of $20.5 million in R&D and G&A for the third quarter of 2015 were product manufacturing variance costs of $8.1 million. We did not recognize any product manufacturing costs in the third quarter of 2014 as we had not yet commenced commercialization of Afrezza.   

For the first nine months of 2015, operating expenses were $71.8 million, a decline of 52.0% compared to the same period in 2014. Total research and development expenses for the nine months ended September 30, 2015 were $23.5 million, a decline of 71.6% compared to the same period in 2014, primarily due to reduced non-cash stock compensation expense resulting from the non-recurring achievement of performance and modification events in 2014 and in the first quarter of 2015. General and administrative expenses for the nine months ended September 30, 2015 were $32.6 million, a decrease of 51.2% compared to the same period in 2014, primarily due to reduced non-cash stock compensation expense resulting from the non-recurring achievement and modification events in 2014 and in the first quarter of 2015.    

The net loss for the third quarter of 2015 was $31.9 million, or $0.08 per share, based on 405.2 million weighted average shares outstanding, compared with a net loss of $36.5 million, or $0.09 per share, based on 394.2 million weighted average shares outstanding for the third quarter of 2014. The number of common shares outstanding at September 30, 2015 was 418.3 million.

Cash and cash equivalents were $32.9 million at September 30, 2015, compared to $107.2 million in the second quarter of 2015. During the third quarter of 2015, we paid $64.3 million upon maturity of the 2015 notes and received $0.7 million in proceeds from warrant and option exercises, $7.2 million in payments from Sanofi for product shipments, and $12.2 million in net proceeds from our at-the-market sales facility. Currently, $30.1 million remains available to borrow under our amended loan arrangement with The Mann Group and $37.5 million of common stock remains available for sale under our at-the-market sales facility. 

Conference Call

MannKind management will host a conference call to discuss these results today, November 9, 2015, at 5:00 p.m. Eastern Time. To participate in the call please dial (800) 708-4539 or (847) 619-6396 and use the participant passcode: 3859 3130.  Those interested in listening to the conference call live via the Internet may do so by visiting MannKind's website at http://www.mannkindcorp.com. 

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: 3859 3130#. 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

Statements contained in this press release that are not strictly historical in nature are forward-looking statements that involve risks and uncertainties. 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, the extent to which MannKind's collaboration with Sanofi for commercialization of Afrezza is able to generate significant product sales for MannKind, difficulties or delays in obtaining regulatory feedback or completing and analyzing the results of clinical studies, MannKind's ability to manage its existing cash resources or raise additional capital, 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, 2014 and periodic reports on Form 10-Q and 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.

(Tables to follow)

MannKind Corporation
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
   
 Three months ended
September 30,		Nine months ended
September 30,
 2015201420152014
Revenue $ —  $ —  $ —  $ — 
         
Operating expenses:        
Research and development  6,341  19,178  23,455  82,684
General and administrative  11,547  19,088  32,649  66,840
Product manufacturing  8,115  —   15,688  — 
         
Total operating expenses  26,003  38,266  71,792  149,524
         
Loss from operations  (26,003)  (38,266)  (71,792)  (149,524)
Other income  67  7,898  1,470  1,638
Loss on extinguishment of debt  (1,049)  —  (1,049)  —
Interest expense on note payable to principal stockholder  (729)  (729)  (2,164)  (2,164)
Interest expense on notes  (4,145)  (5,424)  (17,899)  (11,895)
Interest income  2  1  8  4
         
Net loss $ (31,857) $ (36,520) $ (91,426) $ (161,941)
         
Net loss per share — basic and diluted $ (0.08) $ (0.09) $ (0.23) $ (0.42)
         
Shares used to compute basic and diluted net loss per share  405,199  394,163  401,734  381,332
 
MannKind Corporation
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
   
 September 30, 2015 December 31, 2014
   
Assets    
Current assets:    
Cash and cash equivalents  $ 32,928  $ 120,841
Receivables from collaboration  1,679  50,436
Inventory  23,402   9,670
Prepaid expenses and other current assets   13,227   20,206
Total current assets  71,236  201,153
Property and equipment — net  191,408  192,127
Deferred product costs from collaboration  13,539  —
Other assets   1,831   1,159
Total  $ 278,014  $ 394,439
     
Liabilities and Stockholders' Deficit    
     
Accounts payable  $ 4,444  $  7,394
Accrued expenses and other current liabilities  14,081   26,206
Facility financing obligation  74,163  72,995
Senior convertible notes   —  99,355
Deferred product sales from collaboration  17,474    436
Deferred payments from collaboration  157,145  196,967
Current liabilities  267,307  403,353
Note payable to related party  49,521  49,521
Sanofi loan facility and loss share obligation  43,653  3,034
Senior convertible notes  27,607  —
Other liabilities  14,495   12,301
Stockholders' deficit   (124,569)   (73,770)
Total  $ 278,014  $ 394,439

PLACEHOLDER

CONTACT: Company Contact:

         Matthew J. Pfeffer

         Chief Financial Officer

         661-775-5300

         mpfeffer@mannkindcorp.com