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 2010 Third Quarter Financial Results

10/29/10
PDF Version
MannKind Corporation Reports 2010 Third Quarter Financial Results

VALENCIA, Calif., Oct 29, 2010 (BUSINESS WIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the third quarter ended September 30, 2010.

For the third quarter of 2010 total operating expenses were $42.5 million, compared to $42.8 million for the third quarter of 2009, a decrease of $0.3 million. Research and development (R&D) expenses were $31.4 million for the third quarter of 2010 compared to $30.5 million for the same quarter in 2009, an increase of $0.9 million. This 3% increase in R&D expense was primarily due to increased raw material purchases in the third quarter of 2010 offset by decreased costs associated with the clinical development of AFREZZA® after the submission of its new drug application (NDA) in March 2009. General and administrative (G&A) expenses decreased by $1.2 million to $11.1 million for the third quarter of 2010 compared to $12.3 million in the third quarter of 2009. This 9% decrease in G&A expense was mainly due to decreased salary related costs and the non-recurrence of professional fees related to the insulin acquisition transaction with Pfizer which was completed during the second quarter of 2009.

For the first nine months of 2010, operating expenses totaled $120.5 million, compared to $154.0 million in the first nine months of 2009. R&D expenses for the first nine months of 2010 were $88.1 million, compared to $113.2 million in the first nine months of 2009, a decrease of $25.1 million. The 22% decrease in R&D expenses for the first nine months of 2010 was primarily due to decreased costs associated with the clinical development of AFREZZA, reduced salary-related and other research costs and decreased stock-based compensation expense as certain restricted stock units vested in the second quarter of 2009, which did not recur in 2010. G&A expenses decreased by $8.3 million or 20% to $32.4 million for the first nine months of 2010 as compared to $40.7 million in the same period in 2009. The decrease in G&A expenses for the first nine months of 2010 was primarily due to decreased salary related costs, the non-recurrence of professional fees related to the negotiation and completion of the insulin acquisition transaction with Pfizer during the first half of 2009, and decreased professional fees related to market studies conducted in 2009.

The net loss applicable to common stockholders for the third quarter of 2010 was $45.3 million, or $0.40 per share based on 113.5 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $45.6 million, or $0.42 per share based on 108.8 million weighted average shares outstanding for the third quarter of 2009.

The net loss applicable to common stockholders for the first nine months of 2010 was $132.3 million, or $1.17 per share based on 113.2 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $160.6 million, or $1.54 per share based on 104.4 million weighted average shares outstanding, for the first nine months of 2009.

Cash, cash equivalents and marketable securities were $98.0 million at September 30, 2010 and $32.5 million at December 31, 2009. As of September 30, 2010, the Company had $98.0 million of available borrowings under the loan agreement with The Mann Group, an entity controlled by the Company's principal stockholder. In August 2010, the Company sold $100.0 million of convertible notes in a Rule 144A offering. The net proceeds to the Company from the offering after expenses were $95.8 million.

"During this past quarter we were primarily focusing on preparations for commercial readiness and for an AFREZZA partnership," said Alfred Mann, Chairman and Chief Executive Officer. "In addition, we executed a multi-part strategy in which we added close to $100 million from an offering of convertible notes and put in place a series of equity sales intended to raise additional funds over the next year, provided our stock price exceeds the floor price that we set. Finally, paralleling that transaction we also established a mechanism, which is now being executed, to retire a portion of the debt under The Mann Group loan agreement."

Conference Call

MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern Time. To participate in the call please dial (888) 677-5721 or (210) 839-8507 and use the participant passcode: MANNKIND. To listen to the call via the Internet please visit 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 (866) 393-0872 or (203) 369-0439.

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
  • Corporate Vice President and Chief Scientific Officer Peter Richardson

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 diabetes pipeline includes AFREZZA® and MKC253. MKC253 is currently in phase 1 clinical trials. In March 2009, MannKind submitted an NDA to the FDA requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. In March 2010, MannKind received a Complete Response letter to this NDA from the FDA, requesting additional information. In July 2010, the FDA accepted MannKind's reply to the Complete Response letter and set a PDUFA action date of December 29, 2010. Other products in MannKind's pipeline include the cancer immunotherapy products MKC1106-PP and MKC1106-MT, which have completed phase 1 clinical trials. MannKind maintains a website at 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, including statements related to available borrowings under MannKind's loan agreement, the retirement of debt under The Mann Group loan agreement, future interactions with the FDA and the regulatory status of MannKind's product candidates, 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 seeking or obtaining regulatory approval, 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, 2009 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
(A Development Stage Company)
Condensed Consolidated Statements of Operations
(Unaudited)

(In thousands, except per share amounts)

Three months ended

September 30,

Nine months ended

September 30,

 Cumulative period

from February 14,

1991 (date of

inception) to

September 30,

2010 2009 2010 2009 2010
Revenue $ -- $ -- $ 93 $ -- $ 3,081
Operating expenses:
Research and development 31,411 30,494 88,062 113,232 1,241,875
General and administrative 11,129 12,273 32,436 40,727 331,725
In-process research and development costs -- -- -- -- 19,726
Goodwill impairment -- -- -- -- 151,428
Total operating expenses 42,540 42,767 120,498 153,959 1,744,754
Loss from operations (42,540 ) (42,767 ) (120,405 ) (153,959 ) (1,741,673 )
Other income (expense) 1,948 149 (98 ) 503 (1,990 )
Interest expense on note payable to related party (2,851 ) (1,816 ) (7,476 ) (3,806 ) (14,678 )
Interest expense on senior convertible notes (1,876 ) (1,130 ) (4,297 ) (3,376 ) (15,022 )
Interest income 16 9 22 67 36,953
Loss before provision for income taxes (45,303 ) (45,555 ) (132,254 ) (160,571 ) (1,736,410 )
Income taxes -- -- -- -- (26 )
Net loss (45,303 ) (45,555 ) (132,254 ) (160,571 ) (1,736,436 )
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 $ (45,303 ) $ (45,555 ) $ (132,254 ) $ (160,571 ) $ (1,759,648 )
Net loss per share applicable to common stockholders -- basic and diluted $ (0.40 ) $ (0.42 ) $ (1.17 ) $ (1.54 )
Shares used to compute basic and diluted net loss per share applicable to common stockholders 113,528 108,779 113,248 104,402
MannKind Corporation
(A Development Stage Company)
Condensed Consolidated Balance Sheet
(Unaudited)

(in thousands)

September 30, 2010

December 31, 2009

Assets
Current assets:
Cash and cash equivalents $ 97,928 $ 30,019
Marketable securities 117 2,475
State research and development credit exchange receivable -- current 674 1,500
Prepaid expenses and other current assets 3,309 3,672
Total current assets 102,028 37,666
Property and equipment -- net 202,235 208,229
State research and development credit exchange receivable -- net of current portion 482 918
Other assets 404 584
Total $ 305,149 $ 247,397

Liabilities and Stockholders' Deficit

Current liabilities

$ 25,565 $ 28,853
Senior convertible notes 209,023 112,765
Note payable to related party 252,000 165,000
Stockholders' deficit (181,439 ) (59,221 )
Total $ 305,149 $ 247,397

SOURCE: MannKind Corporation

MannKind Corporation
Company Contact:
Matthew J. Pfeffer
Chief Financial Officer
661-295-4784
mpfeffer@mannkindcorp.com