PropThink

Long/short equity, deep value, event-driven, newsletter provider
PropThink
Long/short equity, deep value, event-driven, newsletter provider
Contributor since: 2012
Company: PropThink
An additional consideration: the exclusivity classification of metadoxine. As a salt of pyridoxine, NCE isn't a shoe-in (somewhat grey area of regulation, though quickly becoming more clear). The company may be able to argue "combination product" following February draft guidance on fixed-dose combinations. Either way, certainly wouldn't count on regulatory exclusivity, which means reliance on IP portfolio. Not a bombproof estate, currently.
On June 26, Auxilium (AUXL) announced that it is merging with QLT Inc (QLTI), largely for tax benefits.
Our full story - http://bit.ly/1qem1dk
The advertising campaign started in early April, so no impact on first quarter figures. You should be looking at the next few quarters for results from the campaign.
Thanks TimeOn. Timing is difficult but will be an interesting 2014/15.
Nice expose Pearson
Great work Pearson! Muck-raking at its finest.
Scrying, we're taking a similar stance. We'd like to see execution on improved enrollment before recommending a Long position. Our full commentary is posted at PropThink.com.
Scrying, agree that the plethora of bullish commentary on a company years from its one major inflection point has riled investors prematurely. Enrollment speed poses a legitimate concern, but the company is aware and taking steps to address the issue; lets see where things stand after Q1, Q2 before jumping to conclusions.
B1 seems to be company guidance at this point, smart in that the company is walking down investor expectations. Will BIIB step in and buy them? Too difficult to call, and a thesis on which we would not base a long position. Better to stick with the commercial potential - if 829 is real, they'll certainly find a partner.
PropThink covered the Zerenex IP/NCE discussion in detail early in the year. Here are a few links for those interested.
http://bit.ly/1e8I6l3
http://bit.ly/XdWp1a
This was far from a sure bet. As mentioned above, expectations were low and should be lower, if not zero, now.
Frankly, it's difficult to say anything about the trial besides darapladib, and the lowering of Lp-PLA2, did not improve CV outcomes. That's pretty final. Will be curious to hear more about subsets, but this is no wonderdrug.
A bit of a head-scratcher. Urinary tox is unnerving and may be leading investors to vacate given company is still playing with optimal dose. Overall, risk/reward is more favorable than ever and we remain long, looking to average down.
Thanks ThinkTrade; your observations are noted. Either way, it's been a great trade. Playing for free now.
We took some flack for our suggestion that IMUC would stagnate following the quarterly. However, our call was spot-on.
The stock is now starting to shape up for a breakout. We suspect the move will be to the upside given the prevailing long-term trend and interest from run-up traders ahead of the pivotal trial results.
John,
Rosa mentioned 25-30 additional subjective and objective endpoints. We'll see if we can track some of this down.
THOR does have a device approved for IIIb, but it's not reimbursed. CMS wants more data.
As is clearly stated in the disclaimer above, members of PropThink are currently long IMUC.
John,
Your concerns are certainly warranted, and your questions are just those that we hope to facilitate with Mr. Rosa this week. Feel free to join us.
As you're well aware, approaching these stories with a bias towards skepticism is warranted. Regardless of the issues raised above, at $35M in enterprise value in May, the risk/reward was skewed in favor of the latter. We would argue the same at $110M.
We plan to post a transcript following.
Bravo Jason.
Thanks Don
If you take issue with points in the article, please address them directly.
No, we have nothing to do with "bashing" tweets.
We have no position in ONTY.
Admittedly, the week 8 (technically day 56) results were not statistically significant, even at the 500 mg arm (http://1.usa.gov/16Yt2lD). But for week 12, the 500 mg dose did see statistically significant results, and the contention that the 500 mg dose is riskier than 250 mg is not supported by published Phase II safety data, which showed that the 500 mg dosing arm has the same or lower overall adverse event rate as the 250 mg arms (58% for the 500 mg q.d. arm, 58% for the 250 mg b.i.d. arm, and 64% for the 250 mg q.d. arm). The serious adverse event rate of 9% was higher than the 5% rate in the 250 mg qd arm, but lower than in both the bid arm (11%) and the 10% seen in the placebo arm. So I would hesitate to say that the Phase III program is riskier at 500 mg, given that the safety profile of the 500 mg dose is generally in line with that of the 250 mg dose.
Also, note that Phase II (Protect-I) data was presented in late 2009 by ChemoCentryx, and that at that point, GSK had not yet licensed vercirnon. They exercised their license option in December 2009, with CCXI confirming in January 2010 (http://bit.ly/14gUcFR), doing so after seeing the Phase II data. Glaxo certainly knew the full clinical results of the Phase II trial, and yet they still licensed it. Phase III development is now under the control of Glaxo, not ChemoCentryx, and GSK decided to focus Phase III efforts on the 500 mg dose, something that CCXI can no longer control
Not sure where you're seeing day 57 Patrick. You're talking about vercirnon?
Henry Su,
Thanks for re-hashing our July 31 article.
http://seekingalpha.co...
For original biotech analysis, visit PropThink.com.
Read the above article, and you'll see that PropThink previously penned a bullish report on IMUC, linked below.
http://bit.ly/16IXfVH
In addition, read the above disclosure and you'll see that members of PropThink are currently long IMUC. Misconstruing our view that the stock will trade sideways, if not lower, through the end of the quarter as "bashing" is unfounded.
Jason and John have outlined a very fair assessment of Arena, Belviq, and the obesity treatment landscape. Investors would be foolhardy to write off the opinions of these two analysts.
Our thesis remains. BioCryst is a poor fundamental investment and will eventually be revealed as such. Bear in mind that while SC Cinryze may be off the table, ViroPharma has a proprietary SC formulation that should move ahead in the clinic later this year, pending input from the FDA.
It's worth pointing out that the fourth quarter of this year will bring a plethora of positive news flow for BCRX - NDA submission, filing, and the movement of a 2nd-gen kallikrein inhibitor into the "pre-clinic." These events, which will undoubtedly catalyze the stock, should not be misconstrued as validation of BioCryst.
We also find it odd that BioCryst's Phase I BCX4161 trial has not been listed on the U.S. National Institutes of Health clinical trials registry. The study was conducted, presumably at a single site, by Quotient Clinical in the UK. We note that Quotient Clinical has a remarkably short history of running clinical trials, evidenced by the group's trial archive. http://bit.ly/19xm9fM
Nice work Jason.
Fletl and Company initiated on DDXS on July 24th with a $1.50 PT, hence the day's rally. Fletl's thesis is in-line with our own - that darapladib offers a free call option on an undervalued growth story.