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 Financial Results

02/03/05
PDF Version
Mannkind Corporation Reports Fourth Quarter Financial Results

Conference Call to Begin Today at 8:30 a.m. EST

VALENCIA, Calif., Feb 03, 2005 /PRNewswire-FirstCall via COMTEX/ -- MannKind Corporation (Nasdaq: MNKD) today announced financial results for the three months and year ended December 31, 2004.

For the fourth quarter of 2004 total operating expenses were $21.7 million, compared with $18.7 million in the fourth quarter of 2003. Research and development (R&D) expenses increased $6.5 million to $20.5 million, primarily due to increased costs associated with the Company's expanded clinical trials and related support for its Technosphere® Insulin program. General and administrative (G&A) expenses decreased by $3.5 million to $1.2 million for the fourth quarter of 2004, primarily as a result of a $2.6 million credit to non-cash stock-based compensation expense compared with a non-cash stock-based compensation charge of $0.8 million in the fourth quarter of 2003.

The net loss applicable to common stockholders for the fourth quarter of 2004 was $21.2 million, or $0.65 per share on 32.8 million shares outstanding, compared with a net loss applicable to common stockholders of $18.6 million, or $0.93 per share on 20.0 million shares outstanding, in the fourth quarter of 2003. The fourth quarter 2004 share count reflects the completion of an offering of Series C convertible preferred stock in the first quarter of 2004 and an initial public offering of common stock during the third quarter of 2004.

"2004 was a year of substantial progress and notable achievements for our Technosphere Insulin System, particularly in the areas of clinical trials and regulatory affairs," said Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation. "Among our fourth quarter highlights, we are pleased to have reported positive data from our U.S. Phase 2b trial and that we held an End-of-Phase 2 meeting with the FDA. Achieving these milestones is significant in that it allows us to move forward into pivotal Phase 3 trials, which already are underway in Europe and are expected to start by mid-year in the U.S."

Alfred Mann, Chairman and Chief Executive Officer added, "Our enthusiasm for the future of our Technosphere Insulin System is based upon its ease-of-use characteristics and its ability to mimic the first phase insulin release of healthy individuals that no other insulin product currently available or in development can claim. Moreover, we now have evidence that our System can significantly lower HbA1c levels -- without inducing severe hypoglycemia -- even in patients whose blood glucose levels are only mildly elevated. Insulin therapy has not traditionally been used in such a population, suggesting that our therapy has the potential to expand the use of insulin by the type 2 diabetes population."

For the year ending December 31, 2004 total operating expenses were $77.1 million, compared with $66.3 million for 2003. R&D expenses were $59.3 million in 2004, up $13.7 million from 2003 primarily due to the expansion of the Technosphere Insulin clinical program. R&D expenses for 2004 were partially offset by a $4.0 million State of Connecticut qualified research and development tax credit exchange. Of this amount, approximately $1.5 million consisted of cash received during the third quarter of 2004. G&A expenses for 2004 totaled $17.9 million, a decrease of $2.8 million from 2003 primarily due to $3.3 million in transition and severance expenses resulting from the consolidation in 2003 of our California operations and reduction of our California workforce, offset by increases, in 2004, in non-cash stock-based compensation expense of $0.2 million and recruiting costs of $0.4 million related to our Danbury workforce. Included in 2004 operating expenses is non-cash stock-based compensation expense aggregating $6.8 million, compared with a non-cash stock-based compensation expense of $4.5 million in 2003. The net loss applicable to common stockholders for 2004 totaled $95.9 million, or $3.80 per share on 25.2 million shares outstanding, compared with a net loss applicable to common stockholders of $67.1 million, of $3.63 per share on 18.5 million shares outstanding, for 2003.

Cash, cash equivalents and marketable securities as of December 31, 2004 were $90.5 million, and included net proceeds of approximately $83.6 million upon completion of the Company's initial public offering, including approximately $4.0 million from the exercise of the underwriter's over-allotment option.

Conference Call

MannKind management will host a conference call to discuss these results today at 8:30 a.m. Eastern Time. To participate in the call please dial (888) 463-4383 from the U.S. or Canada, or (706) 679-5355 from outside the U.S., or listen to the call on the Internet at www.mannkindcorp.com. A telephone replay will be available for 48 hours following completion of the call by dialing (800) 642-1687 toll-free or (706) 645-9291, and entering reservation number 3368397. The web site replay will be available for 14 days.

About MannKind Corporation

MannKind focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. The Company recently commenced Phase 3 clinical trials in Europe of its lead product, the Technosphere® Insulin System, to study its potential for the treatment of diabetes. This System consists of a proprietary dry powder Technosphere® formulation of insulin that is inhaled into the deep lung using the Company's MedTone™ inhaler. MannKind believes that the performance characteristics, unique kinetics, convenience and ease of use of the Technosphere® Insulin System may have the potential to change the way diabetes is treated. 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 our 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 our 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, intellectual property matters, difficulties or delays in seeking or obtaining regulatory approval, manufacturing our lead product candidate, competition from other pharmaceutical or biotechnology companies, our ability to enter into any collaborations or strategic partnerships or obtain additional financing to support our operations, our ability to meet milestones and other risks detailed in our filings with the SEC, including our Registration Statement on Form S-1 and our quarterly reports on Form 10-Q. 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 per share data)      Three Months Ended        Year Ended
                                 Dec. 31,  Dec. 31,   Dec. 31,  Dec. 31,
                                   2004      2003       2004      2003

    Revenue                          $--       $--        $--        $--

    OPERATING EXPENSES:
    Research and development      20,460    13,965     59,266     45,613
    General and administrative     1,237     4,728     17,883     20,699
    Total operating expenses      21,697    18,693     77,149     66,312
    Loss from operations         (21,697)  (18,693)   (77,149)   (66,312)
    Interest income                  433        91        932        398
    Other income (expense)           114        38        226         36
    Loss before provision
     for income taxes            (21,150)  (18,564)   (75,991)   (65,878)
    Income taxes                      --        --         (1)        (1)
    Net loss                     (21,150)  (18,564)   (75,992)   (65,879)
    Deemed dividend related
     to beneficial
     conversion feature
     of convertible
     preferred stock                  --        --    (19,822)    (1,017)
    Accretion on
     redeemable preferred
     stock                            --       (65)       (60)      (253)
    Net loss applicable
     to common stockholders     $(21,150) $(18,629)  $(95,874)  $(67,149)
    Net loss per share:
    Basic and diluted             $(0.65)   $(0.93)    $(3.80)    $(3.63)
    Shares used to
     compute basic and
     diluted net loss
     per share:
    Basic and diluted             32,768    19,975     25,221     18,488



                               MannKind Corporation
                      Consolidated Balance Sheet Highlights
                                  (in thousands)

                                                   December 31, December 31,
    Assets                                             2004           2003
                                                   (unaudited)        (1)
    Current Assets
      Cash and Cash Equivalents                      $86,737        $54,120
      Marketable Securities                            3,796          1,825
      Restricted Cash                                    583             --
      State Research and Development Tax
       Credit Exchange Receivable - Current            1,500             --
      Prepaid Expenses and Other Current Assets        3,265          1,859

    Total Current Assets                              95,881         57,804

    Property and Equipment - at cost, net             66,511         67,323
    Restricted Cash                                       --            559
    State Research and Development Tax
     Credit Exchange Receivable - Net of
     Current Portion                                   1,030             --
    Other Assets                                          61            190

    Total Assets                                    $163,483       $125,876

    Liabilities and Stockholders' Equity

    Current Liabilities                              $13,044         $8,707
    Deferred Compensation - Net of Current Portion        --            284

    Other Liabilities                                     76            120

    Series A Redeemable Convertible Preferred Stock       --          5,188

    Stockholders' Equity                             150,363        111,577

    Total Liabilities and Stockholders' Equity      $163,483       $125,876

      (1)  Information derived from audited financial statements

SOURCE Mannkind Corporation

Dick Anderson, Chief Financial Officer of Mannkind Corporation, +1-661-775-5302, danderson@mannkindcorp.com; or Investor Relations, Ina McGuinness, imcguinness@lhai.com, or Bruce Voss, both of Lippert