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Inhaled Insulin News Hurts MNKD
Friday April 11, 2:11 pm ET
By Grant Zeng, CFA
MannKind Corporation's (NasdaqGM: MNKD - News) lead drug, Technosphere Insulin (TI), is an inhaled insulin product and is in large phase III trials for the treatment of diabetes. The inhaled insulin market has witnessed a major upheaval in recent times with Pfizer (NYSE: PFE - News), Eli Lilly (NYSE: LLY - News) and Novo-Nordisk (NYSE: NVO - News) withdrawing their late-stage candidates citing lack of market prospectus for this class of drugs. Occurrence of lung cancer in diabetic patients treated with Exubera has further cast a shadow over the future of TI.
The company's cash burn is a matter of grave concern, and the lack of any late-stage or approved product adds to the company's woes. While we view the carcinogenicity profile of TI as being safer and better than the rest of the compounds in this class of drugs, we believe the FDA will decide to err on the side of caution and request the company for additional clinical information in a larger sub-group of the diabetic population. This will make the regulatory process longer and costlier for the company, with a high risk of TI suffering the same fate as the other drugs.
Even if TI makes it through the approval process, we do not expect the drug to reach the market before 2011, considering the $1.1 billion in cash burn incurred so far, not to mention the high SG&A costs necessitated to strategically position and distinguish the drug from other therapies. We do not expect the company to achieve profitability without TI achieving blockbuster status -- which is seemingly out of reach in the current market scenario.
MannKind's hopes of bringing a revolutionary technology to the market have been dealt a major blow, and unless some damage limiting and confidence boosting efforts are not undertaken immediately, the shares of the company may sink without a trace. Hence, we maintain our Sell rating on the stock with a target price of $1. MannKind Corporation's (NasdaqGM: MNKD - News) lead drug, Technosphere Insulin (TI), is an inhaled insulin product and is in large phase III trials for the treatment of diabetes. The inhaled insulin market has witnessed a major upheaval in recent times with Pfizer (NYSE: PFE - News), Eli Lilly (NYSE: LLY - News) and Novo-Nordisk (NYSE: NVO - News) withdrawing their late-stage candidates citing lack of market prospectus for this class of drugs. Occurrence of lung cancer in diabetic patients treated with Exubera has further cast a shadow over the future of TI.
MannKind ¹«Ë¾µÄÈÍ·Ò©Æ·£¬ÒȵºËؼ¼Êõ£¬ÊÇÒ»ÖÖÎüÈëÒȵºËزúÆ·£¬²¢ÇÒ½øÈëÁËÌÇÄò²¡ÖÎÁƵÄÈýÆÚÊÔÑé¡£Pfize Eli LilyºÍ Nordisk¹«Ë¾Éù³ÆÓÉÓÚȱ·¦ÕâÀàÒ©Æ·µÄÊг¡¼Æ»®Êé¶øÖÐ;Í˳ö£¬ÎüÈëÒȵºËØÊг¡¾ÀúÁËÒ»³¡´óµÄ±ä¶¯¡£ÓÃÎüÈëÒȵºËØÖÎÁƵÄÌÇÄò²¡»¼Õߵķΰ©·¢ÉúΣÏÕÒ²¸øTIµÄǰ;ÃüÔËÃÉÉÏÁËÒ»²ãÒõÓ°¡£
The company's cash burn is a matter of grave concern, and the lack of any late-stage or approved product adds to the company's woes. While we view the carcinogenicity profile of TI as being safer and better than the rest of the compounds in this class of drugs, we believe the FDA will decide to err on the side of caution and request the company for additional clinical information in a larger sub-group of the diabetic population. This will make the regulatory process longer and costlier for the company, with a high risk of TI suffering the same fate as the other drugs.
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Even if TI makes it through the approval process, we do not expect the drug to reach the market before 2011, considering the $1.1 billion in cash burn incurred so far, not to mention the high SG&A costs necessitated to strategically position and distinguish the drug from other therapies. We do not expect the company to achieve profitability without TI achieving blockbuster status -- which is seemingly out of reach in the current market scenario.
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作者:admin@医学,生命科学 2011-02-07 05:14
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