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 Fourth Quarter and Full Year 2005 Financial Results

02/06/06
PDF Version
MannKind Corporation Reports Fourth Quarter and Full Year 2005 Financial Results

- Conference Call to Begin Today at 9:00 a.m. ET -

VALENCIA, Calif., Feb 06, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the fourth quarter and year ended December 31, 2005.

For the fourth quarter of 2005, total operating expenses were $35.0 million, compared with $21.7 million for the fourth quarter of 2004. Research and development (R&D) expenses increased by $8.1 million to $28.6 million for the fourth quarter of 2005 compared to the fourth quarter of 2004, primarily due to increased costs associated with the Company's expanded clinical development program for Technosphere® Insulin, which is currently in Phase 3 clinical trials in the U.S. and Europe. General and administrative (G&A) expenses increased by $5.3 million to $6.5 million for the fourth quarter of 2005 compared to the fourth quarter of 2004 primarily due to changes in stock compensation expense and increased consulting and various other general and administrative expenses, such as legal and accounting fees.

The net loss applicable to common stockholders for the fourth quarter of 2005 was $33.3 million, or $0.66 per share based on 50.3 million shares outstanding, compared with a net loss applicable to common stockholders of $21.2 million, or $0.65 per share based on 32.8 million shares outstanding, for the fourth quarter of 2004.

For the year ended December 31, 2005, total operating expenses were $118.1 million, compared with $77.1 million for 2004. R&D expenses were $95.3 million in 2005, up $35.9 million from 2004, primarily related to the expansion of clinical trials of the Technosphere Insulin program. G&A expenses increased by $5.1 million to $22.8 million for 2005 as compared to 2004 primarily related to increased compensation and other employee related costs and increased legal, accounting and consulting fees. The net loss applicable to common stockholders for 2005 was $114.3 million, or $2.87 per share based on 39.9 million shares outstanding, compared with a net loss applicable to common stockholders of $95.9 million, or $3.80 per share based on 25.2 million shares outstanding for 2004.

"2005 was an exceptional year for MannKind," said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "In addition to strengthening our balance sheet and expanding our management team, we added to the growing evidence of the safety, efficacy, and other differentiating qualities of our lead investigational product candidate, Technosphere Insulin, an inhalable form of insulin for type 1 and type 2 diabetes."

Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation added, "In recent clinical trials, we observed that the Technosphere Insulin System reduces blood glucose excursions following a meal compared to the effect seen with oral or injectable diabetes medications. At the same time, Technosphere Insulin appears to reduce the risk of late postprandial hypoglycemia commonly associated with other diabetes products, without any evidence of weight gain or deterioration in pulmonary function."

Conference Call

MannKind management will host a conference call to discuss these results today at 9:00 a.m. Eastern Standard Time. To participate in the call please dial (888) 566-5775 or (210) 839-8503. To listen to the call via the Internet please visit www.mannkindcorp.com. A telephone replay will be accessible for approximately 48 hours following completion of the call by dialing (866) 350- 6999 or (203) 369-0042 and entering conference number 1437837. The web site replay will be available for fourteen days.

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 Dick Anderson

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. Its lead investigational product candidate, the Technosphere® Insulin System, is currently in phase 3 clinical trials in the U.S. and Europe to study its safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit www.mannkindcorp.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to MannKind's clinical trials and 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, risks related to the progress, timing and results of clinical trials, the risk that future safety and efficacy studies may not confirm our past clinical results, risks related to intellectual property matters, difficulties or delays in seeking or obtaining regulatory approval, risks related to manufacturing the Company's lead product candidate, risks related to competition from other pharmaceutical or biotechnology companies, risks related to the Company's ability to enter into any collaborations or strategic partnerships or obtain additional financing to support the Company's operations, risks related to the Company's ability to meet milestones and other risks detailed in MannKind's filings with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2004 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 news release. 

MannKind Corporation
                    Consolidated Statements of Operations
                                 (Unaudited)

    (In thousands, except    Three Months Ended              Year Ended
     per share amounts)        December 31,                December 31,
                             2005          2004        2005         2004
    Revenue                     --           --           --           --

    Operating expenses:
    Research and
     development            28,589       20,506       95,347       59,406
    General and
     administrative          6,457        1,191       22,775       17,743
    Total operating
     expenses               35,046       21,697      118,122       77,149
    Loss from
     operations            (35,046)     (21,697)    (118,122)     (77,149)
    Other
     income (expense)           85          114           78          226
    Interest income          1,669          433        3,707          932
    Loss before
     provision for
     income taxes          (33,292)     (21,150)    (114,337)     (75,991)
    Income taxes                 0            0           (1)          (1)
    Net loss               (33,292)     (21,150)    (114,338)     (75,992)
    Deemed dividend
     related to
     beneficial
     conversion feature
     of convertible
     preferred stock             0            0            0      (19,822)
    Accretion on
     redeemable
     preferred stock             0            0            0          (60)

    Net loss applicable
     to common
     stockholders         $(33,292)    $(21,150)   $(114,338)    $(95,874)

    Net loss per share
     applicable to
     common stockholders
     - basic and diluted    $(0.66)      $(0.65)      $(2.87)      $(3.80)

    Shares used to
     compute basic and
     diluted net loss per
     share applicable to
     common stockholders    50,250       32,768       39,871       25,221



                             MannKind Corporation
                     Condensed Consolidated Balance Sheet
                                 (Unaudited)
                                (in thousands)

                                                  December 31,  December 31,
    Assets                                            2005           2004

    Current assets:
      Cash and cash equivalents                      $56,037        $78,987
      Marketable securities                           89,597         11,546
      Restricted cash                                                   583
      State research and development tax
       credit exchange receivable - current            1,194          1,500
      Prepaid expenses and other current assets        3,044          3,265

    Total current assets                             149,872         95,881

    Property and equipment - net                      76,183         66,511

    State research and development tax credit
     exchange receivable - net of current portion      2,031          1,030
    Other assets                                         285             61

    Total                                           $228,371       $163,483

    Liabilities and Stockholders' Equity

    Current liabilities                              $21,365        $13,044

    Other liabilities                                     29             76
    Stockholders' equity                             206,977        150,363

    Total                                           $228,371       $163,483

SOURCE MannKind Corporation

Dick Anderson, Chief Financial Officer of MannKind Corporation, +1-661-775-5302, danderson@mannkindcorp.com; or Investors, Julie Huang, or Media, Robert Stanislaro, both of Financial Dynamics, +1-212-850-5600, mnkd@fd-us.com, for MannKind Corporation