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 2007 Financial Results

03/04/08
PDF Version
MannKind Corporation Reports Fourth Quarter and Full Year 2007 Financial Results

VALENCIA, Calif., March 4 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the fourth quarter and year ended December 31, 2007.

For the fourth quarter of 2007, total operating expenses were $79.1 million, compared to $71.8 million for the fourth quarter of 2006. Research and development (R&D) expenses increased by $7.0 million to $66.8 million for the fourth quarter of 2007 compared to the fourth quarter of 2006, primarily due to increased manufacturing costs (including clinical supplies) for Technosphere Insulin, offset in part by lower purchased services in the associated clinical development program. General and administrative (G&A) expenses increased by $0.3 million to $12.3 million for the fourth quarter of 2007 compared to the fourth quarter of 2006.

The net loss applicable to common stockholders for the fourth quarter of 2007 was $75.0 million, or $0.75 per share based on 99.6 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $71.3 million, or $1.30 per share based on 54.7 million weighted average shares outstanding, for the fourth quarter of 2006.

For the year ended December 31, 2007, total operating expenses were $307.4 million, compared with $233.8 million for 2006. R&D expenses were $256.8 million in 2007, up $65.0 million from 2006, primarily related to increases in manufacturing costs (including clinical supplies) for Technosphere Insulin and associated clinical development program expenses. G&A expenses increased by $8.5 million to $50.5 million for 2007 as compared to 2006 primarily due to costs associated with an increased number of employees and increased professional fees. The total number of employees increased from 545 at the end of 2006 to 609 at the end of 2007.

The net loss applicable to common stockholders for 2007 was $293.2 million, or $3.66 per share based on 80.0 million weighted average shares outstanding, compared with a net loss applicable to common stockholders of $230.5 million, or $4.52 per share based on 51.0 million weighted averages shares outstanding for 2006. The number of common shares outstanding at December 31, 2007 was 101,380,823.

Cash, cash equivalents and marketable securities were $368.3 million at December 31, 2007, $204.2 million at September 30, 2007, and $436.5 million at December 31, 2006. On October 5, 2007, the Company received $250 million in gross proceeds from its self managed registered direct offering of approximately 27 million shares of common stock.

"During this past year, we made excellent progress toward our goal of bringing Technosphere Insulin to market," stated Alfred Mann, Chairman and Chief Executive Officer. "It is clear that in today's environment, to be successful a new therapy must provide a differentiated safety and efficacy profile over existing therapies. We believe that Technosphere Insulin's unique ability to more closely match the normal pattern of insulin secretion following a meal will differentiate our product from other insulins, including rapid-acting analogs and long-acting analogs. Our Technosphere platform now includes MKC-253 (GLP-1), which in a recent Phase 1 trial demonstrated remarkable pharmacokinetics and a highly favorable safety profile. I am proud of what our team is accomplishing and I remain committed to seeing that these innovative products are made available to patients who desperately need improved therapeutic options."

Conference Call

MannKind management will host a conference call to discuss these results today at 9:00 a.m. ET. To participate in the call, please dial (888) 566-5775 or (210) 234-0004. 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 (866) 396-7637 or (203) 369-0522.



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
  • 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 diseases such as diabetes and cancer. Its lead product, the Technosphere® Insulin System, is currently in Phase 3 clinical trials in the United States, Europe and Latin America to study its safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit http://www.mannkindcorp.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to differentiating Technosphere Insulin from other insulins. 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 MannKind's current expectations and involve risks and uncertainties. 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, difficulties or delays in seeking or obtaining regulatory approval, 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, 2006 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
                    Consolidated Statements of Operations
                                 (Unaudited)

    (In thousands, except       Three Months Ended           Year Ended
     per share amounts)            December 31,             December 31,
                                2007          2006        2007          2006

    Revenue                       $-            $-         $10          $100

    Operating expenses:
    Research and
     development              66,751        59,740     256,844       191,796
    General and
     administrative           12,316        12,058      50,523        42,001
    Total operating
     expenses                 79,067        71,798     307,367       233,797
    Loss from operations     (79,067)      (71,798)   (307,357)     (233,697)
    Other (expense) /
     income                     (355)           48        (197)          208
    Interest expense on
     note payable to
     principal stockholder         -          (822)          -        (1,511)
    Interest expense on
     convertible debt           (584)         (222)     (3,408)         (222)
    Interest income            4,996         1,526      17,775         4,679
    Loss before provision
     for income taxes        (75,010)      (71,268)   (293,187)     (230,543)
    Income taxes                  (3)            -          (3)           (5)

    Net loss applicable to
     common stockholders    $(75,013)     $(71,268)  $(293,190)    $(230,548)

    Net loss per share
     applicable to common
     stockholders - basic
     and diluted              $(0.75)       $(1.30)     $(3.66)       $(4.52)

    Shares used to compute
     basic and diluted net
     loss per share
     applicable to common
     stockholders             99,605        54,684      80,038        50,970



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

                                                   December 31,   December 31,
    Assets                                            2007           2006

    Current assets:
      Cash and cash equivalents                     $368,285        $319,555
      Marketable securities                                -         116,924
      State research and development tax credit
       exchange receivable -- current                    831           2,418
      Prepaid expenses and other current assets        9,596          10,650

    Total current assets                             378,712         449,547

    Property and equipment -- net                    162,683          88,328

    State research and development tax credit
     exchange receivable -- net of current
     portion                                           1,500           1,500
    Other assets                                         548             362

    Total                                           $543,443        $539,737

    Liabilities and Stockholders' Equity

    Current liabilities                              $67,558         $44,959
    Other liabilities                                     24              24
    Senior convertible notes                         111,761         111,267

    Stockholders' equity                             364,100         383,487

    Total                                           $543,443        $539,737

SOURCE MannKind Corporation

CONTACT: Dick Anderson, Chief Financial Officer
of MannKind Corporation,
+1-661-775-5302,
danderson@mannkindcorp.com

Web site: http://www.mannkindcorp.com