899460--3/16/2010--MANNKIND

related topics

{product, candidate, development}

{property, intellectual, protect}

{product, liability, claim}

{stock, price, share}

{control, financial, internal}

{condition, economic, financial}

{personnel, key, retain}

{stock, price, operating}

{provision, law, control}

{product, market, service}

{acquisition, growth, future}

{operation, natural, condition}

{cost, regulation, environmental}

We have a history of operating losses, we expect to continue to incur losses and we may never become profitable. If we fail to raise additional capital our financial condition and business would suffer. Deteriorating global economic conditions may have an adverse impact on the loan facility with an entity controlled by our principal stockholder, which we currently cannot predict. If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, our business would be harmed and the market price of our common stock could decline. We face substantial competition in the development of our product candidates and may not be able to compete successfully, and our product candidates may be rendered obsolete by rapid technological change. If we fail to enter into a strategic collaboration with respect to AFREZZA, we may not be able to execute on our business model. If we enter into collaborative agreements with respect to AFREZZA and if our third-party collaborators do not perform satisfactorily or if our collaborations fail, development or commercialization of AFREZZA may be delayed and our business could be harmed. Continued testing of AFREZZA or our other product candidate may not yield successful results, and even if it does, we may still be unable to commercialize our product candidate. If we are unable to transition successfully from a development company to a company that commercializes therapeutics, our business would suffer. If our suppliers fail to deliver materials and services needed for the production of AFREZZA in a timely and sufficient manner, or they fail to comply with applicable regulations, our business and results of operations would be harmed and the market price of our common stock could decline. We have never manufactured AFREZZA or any other product candidates in commercial quantities, and if we fail to develop an effective manufacturing capability for our product candidates or to engage third-party manufacturers with this capability, we may be unable to commercialize these products. We deal with hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business. If we fail to enter into collaborations with third parties, we would be required to establish our own sales, marketing and distribution capabilities, which could impact the commercialization of our products and harm our business. If any product that we may develop does not become widely accepted by physicians, patients, third-party payers and the healthcare community, we may be unable to generate significant revenue, if any. If third-party payers do not reimburse consumers for our products, our products might not be used or purchased, which would adversely affect our revenues. If product liability claims are brought against us, we may incur significant liabilities and suffer damage to our reputation. If we lose any key employees or scientific advisors, our operations and our ability to execute our business strategy could be materially harmed. If our Chief Executive Officer is unable to devote sufficient time and attention to our business, our operations and our ability to execute our business strategy could be materially harmed. Our facilities that are located in Southern California may be affected by man-made or natural disasters. If our internal controls over financial reporting are not considered effective, our business and stock price could be adversely affected. RISKS RELATED TO REGULATORY APPROVALS Our product candidates must undergo rigorous nonclinical and clinical testing and we must obtain regulatory approvals, which could be costly and time-consuming and subject us to unanticipated delays or prevent us from marketing any products. We have only limited experience in filing and pursuing applications necessary to gain regulatory approvals, which may impede our ability to obtain timely approvals from the FDA or foreign regulatory agencies, if at all. If we do not comply with regulatory requirements at any stage, whether before or after marketing approval is obtained, we may be subject to criminal prosecution, fined or forced to remove a product from the market or experience other adverse consequences, including restrictions or delays in obtaining regulatory marketing approval. Even if we obtain regulatory approval for our product candidates, such approval may be limited and we will be subject to stringent, ongoing government regulation. Our insulin supplier does not yet supply human recombinant insulin for an FDA-approved product and will be subject to an FDA preapproval inspection before the agency will approve a future marketing application for AFREZZA. Reports of side effects or safety concerns in related technology fields or in other companies clinical trials could delay or prevent us from obtaining regulatory approval or negatively impact public perception of our product candidates. RISKS RELATED TO INTELLECTUAL PROPERTY If we are unable to protect our proprietary rights, we may not be able to compete effectively, or operate profitably. If we become involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, we would be required to devote substantial time and resources to prosecute or defend such proceedings. If our technologies conflict with the proprietary rights of others, we may incur substantial costs as a result of litigation or other proceedings and we could face substantial monetary damages and be precluded from commercializing our products, which would materially harm our business. We may not obtain trademark registrations for our potential trade names. RISKS RELATED TO OUR COMMON STOCK Our stock price is volatile. If other biotechnology and biopharmaceutical companies or the securities markets in general encounter problems, the market price of our common stock could be adversely affected. Our Chief Executive Officer and principal stockholder can individually control our direction and policies, and his interests may be adverse to the interests of our other stockholders. After his death, his stock will be left to his funding foundations for distribution to various charities, and we cannot assure you of the manner in which those entities will manage their holdings. The future sale of our common stock or the conversion of our senior convertible notes into common stock could negatively affect our stock price. Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management. Because we do not expect to pay dividends in the foreseeable future, you must rely on stock appreciation for any return on your investment.

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899460--3/16/2010--MANNKIND_CORP