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 2014 Fourth Quarter and Full Year Financial Results

02/24/15
PDF Version

VALENCIA, Calif., Feb. 24, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today reported financial results for the fourth quarter and full year ended December 31, 2014.

For the fourth quarter, our operating expenses declined 35% compared to the similar quarter in 2013. Research and development costs were significantly lower, mainly due to a reduction in non-cash compensation expenses and much lower clinical trial expenses following the completion of the Affinity studies in 2013. General and administrative costs declined 29%, mainly reflecting lower non-cash compensation expenses.

For the full year 2014, our total operating expenses increased modestly, with a decrease in research and development costs offset by an increase in general and administrative costs. Research and development costs decreased due to the completion of our Affinity trials, the pivotal clinical trials relating to the efficacy and safety of our novel inhaled insulin, Afrezza. Higher general and administrative costs resulted primarily from increased professional fees, principally related to the negotiation and completion of a collaboration agreement with Sanofi. In addition, professional fees reflected a significant expansion in our program to identify, screen and fully evaluate new product opportunities that will best take advantage of the unique advantages of our Technosphere® drug delivery technology.

The net loss applicable to common stockholders for 2014 was $198.4 million or $0.51 per share based on 385.2 million weighted average shares outstanding, slightly higher than the net loss to common shareholders of $191.5 million, or $0.64 per share on 299.6 million weighted average shares outstanding in 2013. Our common shares outstanding at year-end 2014 were 406.1 million.

Cash and cash equivalents at the end of 2014 were $120.8 million. Subsequent to year end, we received $50.0 million relating to two product development milestones achieved in the fourth quarter of 2014 from our collaboration agreement with Sanofi. In addition, we have $30.1 million of borrowings remaining under the loan arrangement with the Mann Group.

"After achieving a number of significant milestones during 2014, we began the commercial production of Afrezza during the fourth quarter of the year," said Hakan Edstrom, MannKind​'s President and Chief Executive Officer. "With our flagship product, Afrezza©, in the early stages of its commercial launch in the United States, we now enter a very exciting new phase for MannKind."

Conference Call

MannKind management will host a conference call to discuss these results today at 5:00 p.m. Eastern Time. To participate in the call please dial (800) 708-4540 or (847) 619-6397 and use the participant passcode: 3859 3101. Those interested in listening to the conference call live via the Internet may do so by visiting the Company'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 3101#. A replay will also be available on MannKind's website for 14 days.

About MannKind Corporation

MannKind Corporation (Nasdaq:MNKD) focuses on the discovery and development 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. 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 Company'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, 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 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, 2013 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 endedTwelve months ended
 December 31,December 31,
 2014201320142013
         
Revenue   $ —    $ —   $ —    $ — 
         
Operating expenses:        
Research and development   17,560  28,988  100,244  109,719
General and administrative   12,543  17,629  79,383  59,682
         
Total operating expenses   30,103  46,617  179,627  169,401
         
Loss from operations   (30,103)  (46,617)  (179,627)  (169,401)
Other income (expense)   42  (683)  1,679  (635)
Interest expense on note payable to related party   (729)  (1,185)  (2,894)  (6,309)
Interest expense on senior convertible notes and facility financing obligation   (5,654)  (5,101)  (17,549)  (15,153)
Interest income   5  4  9  8
         
Net loss applicable to common stockholders   $ (36,439)  $ (53,582)  $ (198,382)  $ (191,490)
         
Net loss per share applicable to common stockholders — basic and diluted   $ (0.09)  $ (0.16)  $ (0.51)  $ (0.64)
         
Shares used to compute basic and diluted net loss per share applicable to common stockholders   396,793  337,284  385,229  299,591
         
MannKind Corporation
Condensed Consolidated Balance Sheet
(Unaudited)
(in thousands)
 
 December 31, 2014December 31, 2013
     
Assets    
Current assets:    
Cash and cash equivalents  $ 120,841  $ 70,790
Inventory  9,670  — 
Prepaid expenses and other current assets  70,642  5,485
Total current assets  201,153  76,275
Property and equipment — net  192,127  176,557
Other assets  1,159  5,814
Total  $ 394,439  $ 258,646
     
Liabilities and Stockholders' Deficit    
Current liabilities  $ 403,353  $ 127,794
Senior convertible notes  —   98,439
Note payable to related party  49,521  49,521
Other liabilities  15,335  13,605
Stockholders' deficit  (73,770)  (30,713)
Total  $ 394,439  $ 258,646
CONTACT: Company Contact:

         Matthew J. Pfeffer

         Chief Financial Officer

         661-775-5300

         mpfeffer@mannkindcorp.com