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Flamel Technologies Is A Healthy Small Cap With Breakout Potential

Summary

FLML managed to breakout in 2015 with revs of $173mln vs 2014 $15mln.

April 30th is the date of the PDUFA for FLML's filing of a now Unapproved Marketed Drug.

FLML insiders have recently purchased shares at prices near current levels.

Flamel Technologies (NASDAQ:FLML) is a small-cap pharmaceutical company with its headquarters located in France. The company has 2 different new drug approvals (NDAs) and one more on the way, as well as a variety of trials that are expected to announce progress in 2016/early 2017.

FLML Chart

Upcoming PDUFA

The upcoming PDUFA results for FLML's third New Drug Application on April 30th is the highlight of the long thesis. According to one article, FLML can expect to generate $70-80mln in sales from the third NDA to its portfolio. Because the product is already an unapproved marketed drug, FMLM has not disclosed very much information to investors.

FLML is using the FDA's 505(b)(2) pathway to market this unapproved drug. Doing so, FLML is then entitled to 5 years of exclusivity to the product. At 5 years of $70mln, FLML could be looking at the approval of a $350mln revenue stream on April 30th. The growth of the FLML portfolio is reassuring as an investor because management seeks to not only grow earnings, but to grow the intellectual property and exclusivity rights of the portfolio as well.

Micropump Sodium Oxybate

A little more long term, FLML hopes to gain approval of its micropump sodium oxybate which enhances the efficiency Xyrem, a drug that treats narcolepsy. Jazz Pharmaceuticals (NASDAQ:JAZZ) is the owner of Xyrem until 2019 and 2024 according to patents. However, there are now 3 different companies that have filed to create a generic version of Xyrem with the FDA. The decision on whether these companies can create a generic version of Xyrem by invalidating JAZZ patents could happen in 2016.

FLML micropump

Now here is the interesting part of the story and where FLML has a market...


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