MannKind Corp (MNKD)

The MNKD pipeline includes a market disrupting insulin product called Afresa that has been proven, in 40 clinical trials, in thousands of patients, over multiple years, to address diabetes in a way that reduces or eliminates the life and health threatening glucose swings (including hypoglycemia), safely and effectively. Afresa changes the rules of diabetic treatment by allowing diabetics to maintain normal blood glucose levels simply, discreetly and without needles.

Diabetes affects approximately 170M humans worldwide and is increasing, with the WHO predicting 300 million diabetics by 2025. Global sales of diabetes drugs totaled US$27.3 billion last year, making diabetes the No. 4 drug class, according to IMS Health. Decision Resources, one of the world's leading research and advisory firms for pharmaceutical issues, surveyed U.S. and European endocrinologists and found that Afresa (a non-injectable, short-acting insulin with significantly improved efficacy over Novo Nordisk's NovoRapid/NovoLog) would earn a 50 percent patient share in type 1 diabetes alone in the United States and a 58 percent patient share in Europe. I peg current realistic value at closer to $20.

PDUFA date for Afresa is January 16th, and a partnership with a major pharmaceutical company appears inevitable at that time, with sales to begin by mid-year. This assessment totally ignores the value of the cancer vaccine pipeline and drug delivery platform licensing.