MannKind (MNKD 1.77%) -- one of the most contentious biotech stocks of 2012 -- has kept investors on the edge of their seats. As the company works toward approval from the Food and Drug Administration, investors continue to debate the ultimate commercial potential of MannKind's ultra-rapid inhalable insulin product, Afrezza. Can this company revolutionize the way diabetes is treated and become a blockbuster, or will Afrezza be a massive flop?
In a brand new premium report on MannKind, we outline every key topic investors have to know with this risky stock. Below is a short sample -- focusing on two risks facing MannKind -- of what you can find in the full version.
2 Risks Investors Can't Ignore
FDA rejection
The FDA has already passed on approval of Afrezza twice. The chance exists that it could do so again. If this happens, the decision would be devastating to MannKind.
How likely is a third rejection? Everything hinges on how well the company's newer Dreamboat inhaler performs as compared against the original MedTone inhaler used in earlier clinical trials. The company believes that the new inhaler works as well as the initial device, and it seems likely that MannKind's design of the upcoming phase 3 studies will be sufficient for proving the company's case. However, the risk of FDA rejection remains a possibility.
Commercial failure
Even if we assume that MannKind sails through phase 3 studies of Afrezza, gains FDA approval, and reaches an agreement with a partner with plenty of money, the company still faces a major hurdle: Patients must actually buy the product.
Pfizer (PFE 1.02%) and Nektar Therapeutics (NKTR +3.88%) weren't able to convince patients that their drug was a better option to the injected insulin they were accustomed to, and sales suffered as a result. MannKind's product is certainly more convenient than Exubera, and the company completed a study in 2011 that suggests patients using Afrezza viewed the therapy more positively than standard insulin therapy. Exubera's failure can serve as a model for what MannKind shouldn't do, and Afrezza will also have to be available at the right price.
