TherapeuticsMD (TXMD) has been sparsely covered on this board, with the latest article
2 months ago, but the stock has been up 60% since that last publication
and as such bears examination. In particular, TXMD started going in
September, after a string of announcements which I will detail that
present a very rosy future. The company already boasts a fairly robust
Institutional Investor base (Wellington, Fidelity, Franklin Templeton,
RA Capital, UBS O'Connor, and Broadfin among largest shareholders) and I
believe despite the run up, there is still an attractive risk/reward at
current levels and that the company has several promising catalysts
upcoming which should drive further out-performance.
First, a rundown of the catalysts to date (from $2 to $4):
The House Bill
The background here is that due to outbreaks of contaminated drugs arising from compounding pharmacies, the inability to track compounding pharmacies, distribution, manufacturing, and quality control of prescription drug products, the government is attempting to ensure consumer safety and implement new rules over the nation's 22k compounding pharmacies (allowing the FDA direct oversight). On October 3rd, the House passed compounding legislation which should be taken up by the Senate when the session resumes. Under Section 503A of the new legislation, in order to assess drugs for the "Do Not Compound List", drugs that meet certain criteria will be considered for the exclusive list. For TXMD, the key components including the prohibition of essential copies of approved drugs, hard to make drugs, and inaccurate claims, serve to protect its key oral estrogen/progesterone Phase III asset that will be launching in 2016. (If approved, it will be the only FDA approved bio-identical hormone-replacement therapy (HRT) combination drug, targeting a $2b compounding drug market (of unapproved ones only, the branded ones are at $4b market size).
continue to read here
First, a rundown of the catalysts to date (from $2 to $4):
The House Bill
The background here is that due to outbreaks of contaminated drugs arising from compounding pharmacies, the inability to track compounding pharmacies, distribution, manufacturing, and quality control of prescription drug products, the government is attempting to ensure consumer safety and implement new rules over the nation's 22k compounding pharmacies (allowing the FDA direct oversight). On October 3rd, the House passed compounding legislation which should be taken up by the Senate when the session resumes. Under Section 503A of the new legislation, in order to assess drugs for the "Do Not Compound List", drugs that meet certain criteria will be considered for the exclusive list. For TXMD, the key components including the prohibition of essential copies of approved drugs, hard to make drugs, and inaccurate claims, serve to protect its key oral estrogen/progesterone Phase III asset that will be launching in 2016. (If approved, it will be the only FDA approved bio-identical hormone-replacement therapy (HRT) combination drug, targeting a $2b compounding drug market (of unapproved ones only, the branded ones are at $4b market size).
continue to read here
1 comment:
Just great ... Another "Colchicine" or "Makena" type scenario, when something was cheap (because the drug has been around for decades (or in the case of colchicine, millennia), but because of the perverted FDA approval process giving patent protection to one company making a copy of an older drug, the price shoots up 1000% or more.
Kenneth Woliner, MD
www.holisticfamilymed.com
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