$RPRX…looking to establish a starter position tomorrow in $RPRX. Excellent DD on the board and many have been in this one for some time already, including great info/thoughts from both BioHunter and $heff. Link back to $heff’s post that included a link to company presentation on their lead product candidate, Androxal:
Two major upcoming catalysts, FDA advisory committee meeting on November 3rd and then a PDUFA date of November 30th. No anticipated news on other product candidates in the meantime. The FDA will review Androxal (to be renamed) for the treatment of secondary hypogonadism in overweight men, i.e. to restore/raise serum testosterone levels.
Positives:
Several clinical trials have been conducted and results are convincing; Androxal also performs very well vs. currently approved products that increase testosterone e.g. testosterone gels. Advantage of Andoxal is it’s mechanism of action which restores/enhances the function of the reproductive endocrine axis, stimulating natural levels and cycles of T production. Testosterone gels increase T but reduce levels of other hormones of the axis e.g. FSH and LH. Also, T gels reduce sperm counts whereas Androxal does not. Details in company’s presentation and most recent 10Q:
Also according to the 10Q, company is fine on cash through mid-2016 with $32M on hand and a quarterly burn rate of $8M or so. As stated in the 10Q:
“We anticipate that our current liquidity will be sufficient to continue the development of our product candidates into the second half of 2016. We continue to explore potential corporate partnering opportunities for assistance in the clinical development funding and commercialization of our products, as appropriate; however, there can be no assurance that an acceptable corporate partnering opportunity will be successfully completed or that our current liquidity will be sufficient to fund all of our product development needs.”
MUST READ is a report by SAC Tracker discussing the upcoming FDA panel and what they’ll be looking for:
Unless something material occurs that changes the investment thesis, I’m comfortable holding $RPRX prior to the FDA panel meeting on November 3rd, but will not hold through. This is due to my trading style but also a couple of concerns, one of which is discussed in the SAC Tracker report.
The FDA will want to see that safety has been adequately addressed in the trials already conducted or to be conducted by $RPRX, specifically with regards to cardiovascular risk. Adverse events are reported in the company presentation (many slides there, but look near the end), and don’t seem to be alarming or out of the ordinary to me.
The other negative is in part due to my lack of knowledge regarding patents, but worth noting. Androxal (enclomiphene) is a single isomer of clomiphene citrate, the latter of which is already approved as Clomid, a drug for the treatment of female infertility. Male infertility is an off-label use for Clomid. With regards to patents, the difference with Androxal is that it is a single isomer only, rather than Clomid which consists of both isomers of clomiphene citrate. $RPRX seems to be fine for now on patents but there are some going concerns and litigation as discussed in “Note 6 – Commitments and Contingencies” of the 10Q linked above, with the concluding statement:
“Adverse determinations in litigation proceedings could require us to seek licenses which may not be available on commercially reasonable terms, or at all, or subject us to significant liabilities, in which case we may not be able to successfully commercialize or out-license enclomiphene until such patents expire or are otherwise no longer in force.”
I like to think that the management of $RPRX know what they’re doing and all is well regarding the patent, but don’t know enough about patent law etc. to make my own call in this regard.
My plan is to establish a starter position tomorrow or sometime later this week if I can’t pick up a good bid Monday, and build a larger position in the next 2-3 weeks. I like $RPRX moving into the November catalysts and don’t anticipate negative news prior to the FDA committee meeting. I do not plan on holding into the meeting—and would exit my position if obtaining solid gains prior to November—due to my general unwillingness to hold through binary events as well as the specific concerns outlined above, particularly the question of whether or not the panel will suggest that more safety data is needed.
Events that would change my overall trade thesis are negative updates with regards to patent(s), or news with regards to safety issues (unlikely as trials are completed).
Thanks to others on the board for alerting $RPRX, and good luck to all this week!
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