One of the best ways to develop a picture of any company is with the SWOT analysis -- a look at a company's strengths, weaknesses, opportunities, and threats. Today, I'd like to focus on MannKind (Nasdaq: MNKD) as its inhaled insulin, Afrezza, prepares for a return trip in front of the Food and Drug Administration.


  • Al Mann. The founder, chairman, and CEO has a lot riding on the company, considering he owns 42.5% of it.
  • A drug that works. Having passed its clinical trials many times over, the risk of failure in the clinic has been removed.


  • Al Mann. From my prospective, the billionaire seems so confident that it could be detrimental to investors. Comments he made before the first FDA decision led many people -- me included -- to think an FDA approval was imminent.
  • Research and development. Long-term growth relies on expensive research to develop additional drugs.


  • Competition. Afrezza will have to compete with injected insulin, but the market for inhaled insulin is wide open after Pfizer (NYSE: PFE) stopped marketing Exubera, developed with Nektar Therapeutics (Nasdaq: NKTR), and Eli Lilly (NYSE: LLY) and Novo Nordisk (NYSE: NVO) dropped their inhaled insulin programs.
  • Partnership. Licensing the rights to sell Afrezza in the U.S. and abroad should garner the company a large milestone payment. Waiting until after an FDA approval has increased the risk, but it also increases the potential reward.
  • Platform. The company's Technosphere technology, which helps the insulin get from the inhaler to the bloodstream, is a platform upon which other inhaled drugs could be developed.


  • FDA. Predicting whether the FDA will approve Afrezza is difficult. Another delay would be costly.
  • Demand. Exubera never caught on with diabetics. The device that delivers Afrezza is much smaller, which should help, but there's no guarantee that diabetics will trade in their needles and pumps for inhalers.

I think MannKind's strengths and opportunities outweigh its weaknesses and threats, but the company is still quite risky because there's no guarantee of an FDA approval no matter how confident its founder is. Proceed with caution, Fools.

What's your take? Are there parts of MannKind's SWOT that need more detail? Fill in the blanks in the comments section below.

Editor's note: An earlier version of this article said that both Pfizer and Nektar Therapeutics marketed Exubera. Under an agreement between the two companies, only Pfizer marketed that product. The Fool regrets this error.

Motley Fool Rule Breakers is always on the hunt for hot drug stocks and other cutting-edge picks. See all of our latest discoveries with a free 30-day trial. 

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is a Motley Fool Inside Value selection. The Fool has a disclosure policy.