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 2012 Fourth Quarter and Full Year Financial Results

02/11/13
PDF Version
MannKind Corporation Reports 2012 Fourth Quarter and Full Year Financial Results

VALENCIA, Calif.--(BUSINESS WIRE)--Feb. 11, 2013-- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the fourth quarter and year ended December 31, 2012.

For the fourth quarter of 2012, total operating expenses were $33.5 million, compared to $30.6 million for the same quarter of 2011, an increase of $2.9 million. Research and development (R&D) expenses were $25.3 million for the fourth quarter of 2012 compared to $20.2 million for the same quarter of 2011, an increase of $5.1 million. This 25.2% increase was primarily due to increased clinical trial related activities for the fourth quarter of 2012 as compared to the same quarter of 2011. General and administrative (G&A) expenses were $8.2 million for the fourth quarter of 2012 as compared to $10.3 million for the same quarter of 2011, a decrease of $2.1 million. This 20.4% decrease in G&A expense was primarily due to decreased legal expenses during the fourth quarter of 2012, as compared to the same quarter of 2011.

Other expense of $13.3 million for the fourth quarter of 2012 was primarily due to an adjustment in the fair value of a forward purchase contract with a related party settled in December 2012.

For fiscal year 2012, operating expenses totaled $147.0 million, compared to $140.6 million for fiscal year 2011, an increase of $6.4 million. Total R&D expenses were $101.5 million for fiscal year 2012, compared to $100.0 million for fiscal year 2011, an increase of $1.5 million. This 1.5% increase was primarily due to increased clinical trial-related expenses of $24.9 million, offset by the non-recurrence of $16.0 million in expenses recorded during fiscal year 2011 in connection with the settlement of the terminated insulin supply agreement and decreased salary-related expenses of $8.6 million resulting from the February 2011 restructuring. G&A expenses were $45.5 million for fiscal year 2012, compared to $40.6 million for fiscal year 2011, an increase of $4.9 million. This 12.1% increase was primarily due to $6.5 million in non-cash litigation settlement expenses incurred during fiscal year 2012, partially offset by decreased salary-related costs as a result of the February 2011 reduction in force.

Other expense for fiscal year 2012 was $1.2 million compared to other income of $1.5 million in the prior year. For 2012, other expense reflects the adjustment in fair value of forward purchase contracts. In 2011, other income was primarily realized gains on the termination of foreign exchange hedging contracts.

Net loss applicable to common stockholders for fiscal year 2012 was $(169.4) million, or $(0.94) per share based on 180.9 million weighted average shares outstanding, compared to net loss applicable to common stockholders of $(160.8) million, or $(1.32) per share based on 121.8 million weighted average shares outstanding for fiscal year 2011. The number of common shares outstanding at December 31, 2012 was 286,035,082.

Cash and cash equivalents were $61.8 million at December 31, 2012 and $2.7 million at December 31, 2011.

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) 447-0521 or (847) 413-3238 and use the participant passcode: 34087260. To listen to the call via the Internet please visit http://www.mannkindcorp.com. The web site replay will be available for 14 days. 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: 3408 7260#.

Presenting from the Company will be:

  • Chairman and Chief Executive Officer Alfred Mann
  • President and Chief Operating Officer Hakan Edstrom
  • Corporate Vice President and Chief Financial Officer Matthew Pfeffer

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its lead product candidate, AFREZZA®, is in late stage clinical investigation for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia.

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.

     
MannKind Corporation
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)

(In thousands, except per share amounts)

 

 

 

 

Three months ended

December 31,

 

 

Year ended

December 31,

Cumulative period

from February 14,

1991 (date of

inception) to

December 31,

  2012       2011     2012       2011     2012  
Revenue $ —   $ —   $ 35   $ 50   $ 3,166  
Operating expenses:
Research and development 25,275 20,242 101,522 99,959 1,467,573
General and administrative 8,211 10,337 45,473 40,630 425,704
In-process research and development costs — — — — 19,726
Goodwill impairment   —     —     —     —     151,428  
Total operating expenses   33,486     30,579     146,995     140,589     2,064,431  
Loss from operations (33,486 ) (30,579 ) (146,960 ) (140,539 ) (2,061,265 )
Other income (expense) (13,269 ) 66 (1,191 ) 1,541 (2,267 )
Interest expense on note payable to related party (2,170 ) (3,035 ) (10,491 ) (10,883 ) (38,825 )
Interest expense on senior convertible notes (2,861 ) (2,849 ) (11,139 ) (10,941 ) (39,933 )
Interest income   5     —     7     18     36,996  
Loss before provision for income taxes (51,781 ) (36,397 ) (169,774 ) (160,804 ) (2,105,294 )
Income tax benefit   —     —     (408 )   —     (382 )
Net loss (51,781 ) (36,397 ) (169,366 ) (160,804 ) (2,104,912 )
Deemed dividend related to beneficial conversion feature of convertible preferred stock — — — — (22,260 )
Accretion on redeemable preferred stock   —     —     —     —     (952 )
Net loss applicable to common stockholders $ (51,781 ) $ (36,397 ) $ (169,366 ) $ (160,804 ) $ (2,128,124 )
Net loss per share applicable to common stockholders — basic and diluted $ (0.23 ) $ (0.30 ) $ (0.94 ) $ (1.32 )
Shares used to compute basic and diluted net loss per share applicable to common stockholders   229,234     122,357     180,855     121,817  
 

   
MannKind Corporation
(A Development Stage Company)
Condensed Consolidated Balance Sheet
(Unaudited)

(in thousands)

 

 

December 31, 2012

December 31, 2011

 
Assets
Current assets:
Cash and cash equivalents $ 61,840 $ 2,681
Prepaid expenses and other current assets   4,970     3,140  
Total current assets 66,810 5,821
Property and equipment — net 183,961 193,029
State research and development credit exchange receivable — net of current portion 313 473
Other assets   230     230  
Total $ 251,314   $ 199,553  

Liabilities and Stockholders’ Deficit

Current liabilities $ 144,775 $ 25,360
Senior convertible notes 97,583 210,642
Note payable to principal stockholder 119,635 277,203
Stockholders’ deficit   (110,679 )   (313,652 )
Total $ 251,314   $ 199,553  
 

Source: MannKind Corporation

MannKind Corporation
Matthew J. Pfeffer
Chief Financial Officer
661-775-5300
mpfeffer@mannkindcorp.com