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I just got a call about my proxy as I had voted soon after receiving it I was a bit surprised until the person asked if I voted in support (which I would not disclose). I wonder if the vote is close on the poison pill?
I agree with Brad about webcasting the breakouts if a company is going to have one to be fair to all investors. I would not be so hard on NPS as he was though as I've seen cases where no 8-k was ever released.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=96089517
Its kinda ironic in a way if RNA/GSK hadn't run the Phase 3 they may have a more favorable sounding AA path (though still need confirmatory trial).
Its that different 5-10% I would like to know about . SRPT painted a little more optimistic picture then the RNA letter. I don't have a position in RNA (though I picked it my charity portfolio, I probably got too greedy for an entry in RNA and missed my chance). I am not in the camp of one or the other I think its a good sign FDA is giving both a path forward though wanting to see more supportive data. I do however favor SRPT (and am long) on what we know of tolerability thus far.
Instead of competing they should (illegally) collude to make sure the data is consistent and then split up which of the remaining exon's each go after kinda like how early days of ERT development (less Fabry) (kidding of course)
SRPT / RNA:
I give credit to RNA for disclosing the FDA letter (in 6-k filing) http://www.sec.gov/Archives/edgar/data/1574111/000117184314002670/exh_992.htm
It appears SRPT and RNA have very similar guidance though it would be nice to see the exact wording of concerns FDA has with SRPT data (I couldn't find it released).
So was Matt Emmens pushed out (at Vertex) because it was discovered he was secretly there to facilitate the Shire acquisition of Vertex? .
I didn't mean SHPG would buy ITMN, just general comment regarding the fact that single product company is easier to be acquired because you pretty much can get rid of almost everything except the product.
A lot of BMRN's value comes from RD and pipeline, so you can't get rid of them, but there would be some overlap between the two companies. Do you let BMRN standalone then? That would be tough given SHPG has similar standalone unit already. My opinion has been that the acquirer of BMRN will be someone who mostly let BMRN standalone, aka SNY/Genzyme, then build around it, that's where BMRN's value is.
Well BMRN doesn't have Warburg Pincus pushing them so maybe it would take a bit higher price then I thought to do the deal . It would complicate things but perhaps Shire dumps the PARP and PEG-PAL/Kuvan to Merck KG to make it a bit more affordable. The synergy just seems to make a lot of sense for them that it would be worth paying a bit more.
I've been long ITMN but thought GILD as most likely or perhaps as longer shot Actelion (I think UTHR makes a good fit for them but don't see Martin giving up that much of the company to do a deal).
Shire / NPSP / BMRN:
I find it a bit surprising Shire would pay $5B for NPSP at about twice the costs (maybe a little more) they could probably get a much greater synergistic fit with BMRN. I don't follow NPS that closely so I'm not sure on its pipeline, BMRN's is probably as good as its ever been and there are likely a great number of synergies with Shire granted it would require them to line up more cash for the deal. Its interesting BMRN is looking to outlicense their PARP. When TKT was looking for a buyer of their EPO product is when the company got sold.
The Jefferies Conference Webcasts which go from 6/2-5 can be accessed directly from here
http://wsw.com/webcast/jeff82/
(Registration required)
When I was a UTHR long I liked that they broke out their earnings in a (creative) non-GAAP way. They have been (extremely) generous with options so under GAAP their EPS was low/negative but much more impressive when they were factored out. When I am not a shareholder in a stock I guess I see it differently . I guess it is good to attract investors who don't look closely at the numbers.
RTRX:
I believe Martin said it was a very small amount not material in relation to the Balance Sheet (in light of 80 million financing).
I don't follow charts but that is an impressive one year chart I guess that speaks to expectations (or lack there of)
http://finance.yahoo.com/q/bc?s=SANN.SW+Basic+Chart&t=1y
I didn't look much but if this PR is accurate then their market cap is not that large still (a little under 4 million shares)
http://finance.yahoo.com/news/santhera-reports-financial-figures-2013-050201996.html
It seems the benefits peak at 26 weeks and begin to diminish. I guess given the severity of the patients it may not be unexpected.
I didn't look as closely as you but if they excluded patients I wouldn't be surprised. The p values are around what would make me a bit cautious/suspicious if I were an investor with such a small trial a couple of patients get excluded and the study loses significance. That being said I have nothing against the drug getting approved if it can help some patients a little bit.
nintedanib:
I think it was @lomu_j who first pointed out this study which BI recently started. It seems rather odd to initiate with 2 positive trials in hand
http://clinicaltrials.gov/ct2/show/NCT01979952?term=nintedanib&rank=31
Here is the study in combo with Pirfenidone.
http://clinicaltrials.gov/ct2/show/NCT01136174?term=nintedanib&rank=27
and the followup
http://clinicaltrials.gov/ct2/show/NCT01417156?term=nintedanib&rank=45
Buy tons of portions
Thanks for clarification, I didn't notice that. Wonder why they wouldn't offer to everyone not as if they don't have the cash
Thanks for the link Peter.
Its interesting in that model the person quoted says after significant fibrosis has developed. I wonder if they need to treat for longer periods to better show the reversal of the fibrosis and have a differentiated product. With such a heterogeneous disease and relatively small trials so far I wonder if FVC (even though improved) is not the ideal measure for this agent. Someone on twitter noted the (relatively) small percentage continuing/finishing the extension which is curious given the wording of safety/tolerability.
I have found the Fibrogen data to be interesting especially if indeed they have reversed fibrosis in even a small number of patients. Perhaps being private they don't need to disclose more information but I would be curious to see the data presented to better understand it. I am also curious as to the reliability of measuring fibrosis as they did. From a competitive perspective (with Pirfenidone/nintedabib) I do not see them as "threat" and perhaps it'll be good for patients:
1) Its IV so likely not going to be first line unless data is exceptional. If IPF follows the PAH model it would be the more severe but Fibrogen has shown a better susbset in milder disease patients.
2) It would seem a different mechanism and from whats reported it doesn't seem to preclude combining with either oral treatment.
3) Fibrogen is moving quite slow in their development.
This is what was stated when BI received Orphan designation.
The sponsor has provided sufficient information to show that nintedanib might be of significant benefit for patients with idiopathic pulmonary fibrosis based on results of early studies which showed fewer declines in lung function with nintedanib treatment compared with placebo (a dummy treatment). In addition nintedanib showed reductions in exacerbations (flare-up of symptoms) and an improvement in patients’ quality of life.
These assumptions will need to be confirmed at the time of marketing authorisation, in order to maintain the orphan status.
[Emphasis added]
Thanks for the reply JQ.
Intermune alluded to the driver of the results being those patients that were worse off (post hoc analysis). I would imagine they will try to broaden the label/use in the EU though perhaps they will need more prospective data for that.
I was surprised to that one of (in sharp contrast to the other) would try both. He said it in the context of adding the other if the patient progresses. I guess if the patient is tolerating it, it makes some sense. The doctor gave the PAH analogy though the orals are much better tolerated in that disease. I have to listen again but Dan Welch may have said the small trial with two had most of the patients being able to tolerate the drugs (he did say it wasn't published though).
ITMN has a NAC+Pirfenidone study underway. Given the poor showing in PANTHER I thought the combo may come up on the call but it seemed the news had just broken. There was a very interesting (to me at least) abstract presented it was with a small number of Japanese patients and used Inhaled NAC so could be spurious finding.
http://66.78.214.3/cpaper/myitinerary/publication-51138.html
ITMN:
I may be a bit biased but I find ITMN calls with Investigators/Physicians to be only slightly biased. One thing that came up was the use of the drug in more advanced patients. I didn't catch who replied but basically said it is quite preposterous that it would not work in them and rather arbitrary to use the FVC cut off that was used. I know in the EU Intermune has had to adhere to more strict definitions to get reimbursed but I wonder if they may run into less problems in the US.
A good question for jq (Or anyone else who cares to answer) even though this is a larger orphan disease why do some diseases (MPS come to mind) have strict entry criteria but yet get a broad label. What would make IPF different?
Another thing that came up that I found interesting two of doctors (think one was Paul Noble not sure who the other was) were asked about combo use with BI and one said unlikely the other seemed almost eager to try it. Dan Welch noted there was a safety study in Japan with the two drugs but results were not published.
On NAC the docs on the call didn't have opportunity to review the NEJM paper but seemed like they would stop using. One noted a low bar for using in his patients (think said 2/3) other about 20%. This was based on the question of reported cardiovascular events in the study. I am not familiar with prior NAC results in IPF patients showing this (I don't know either way). It did appear that there was a slight imbalance in diabetes and coronary artery disease (also in % female but that may be less correlated).
NAC ARM of PANTHER Trial in IPF (The 3 drug arm was terminated for INCREASE in mortality)
http://www.nejm.org/doi/full/10.1056/NEJMoa1401739
Thanks again to @AndyBiotech for the links.
ITMN will have a conference call at 8PM Eastern to discuss the data release. The webcast should be available here:
http://edge.media-server.com/m/p/hiohovw4/lan/en
Note they will also have a conference call on the 20th at 8PM Est. That webcast should be available here:
http://edge.media-server.com/m/p/o7bnuakc/lan/en
Pirfenidone and Nintedanib NEJM links
Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis
http://www.nejm.org/doi/full/10.1056/NEJMoa1402584
A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
http://www.nejm.org/doi/full/10.1056/NEJMoa1402582
Thanks to @AndyBiotech
CW laughed it off and of course wouldn't comment but I wonder about the odds of a settlement. I have no expert opinion but even with the 3x week formulation (perhaps even more so) I would guess TEVA would consider a settlement.
Not surprising I am long a couple of your picks (ITMN, ENTA) and like/watch some of the others (PRTA and RARE). Even though I like RARE I am a bit surprised you picked it up now. I realize you take a long term view (so do I) I just see the valuation as still quite high given they are basically still phase 2 assets. I certainly could see them never reaching what I would see as a fair valuation (probably in the mid 20's) or my buy range (upper teens - low 20's). Is there a program in particular you like?
Not sure it was that much of a drop but what about Priceline?
XNPT:
I don't follow it too closely these days, I did however see a tweet from @AndyBiotech about their being a fast lymphocyte drop for 829 (as compared to BG-12) in MS after a week of dosing. Also I am not sure how far ALKS is on their candidate. XNPT claims to have IP though.
This is not a new offering it is registration of the shares/warrants sold in January. It will be interesting to see what happens when its effective, since the stock has come down some I wonder how many will still seek a profit though far below the highs.
OT Briefing Webcasts:
From the link you posted http://www.briefing.com/investor/calendars/conference-calls/ I see three months (March, April and May) and can click on any of the months to see webcasts for that month. If in your browser/MAC (I am using Chrome on a PC) it doesn't appear with the months you can use the link to the specific month such as
http://www.briefing.com/investor/calendars/conference-calls/2014/05 for May 2014.
OT Earningscast:
I have noticed in the past some broadcasts (it seems ones that don't used edge.media-server) are only available as live broadcasts. To get the replay I would have to go to the company site and get the link there (unless it was available at http://www.briefing.com/investor/calendars/conference-calls/2014/05 (free registration is required). I also recently noticed they no longer have downloadable podcasts. I thought that may be because I am not paying (I emailed them about something a while ago and they said they would be ending that) but perhaps they are having some glitches?
I should have banned you from guessing .
Probably the best raw talent I have seen I guess with the .0001% body fat he was susceptible to a lot of injuries.
Another former Red in his first full season had 80 SB and was only caught 11 times! I thought he had the talent to both steal a 100 bases and hit 50 home runs (and I am not a Reds fan ). Anyone care to guess who it was?
The $ekso story is coming up on bloomberg TV @ http://www.bloomberg.com/tv/
Webcast Calendar
[Please see updating procedure at
the end of this post. All times are
U.S. ET unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed entries > ~1 month old. Added Deutsche Bank
Needham 13th Annual Healthcare Conference
4/8-9
http://wsw.com/webcast/needham65/#table1
Username: needham
Password: healthcare13
Deutsche Bank 39th Annual Health Care Conference
5/7-9
http://conferences.db.com/americas/healthcare14/
Bank of America Merrill Lynch Health Care Conference
5/13-15
UBS 2014 Global Healthcare Conference
5/19-21
http://www.ubs.com/global/en/investment-bank/key-investor-conferences/global.html
Jefferies 2014 Global Healthcare Conference
6/2-5
http://www.jefferies.com/OurFirm/Conferences/325/
Goldman Sachs Healthcare Conference
6/10-11
Citi European Healthcare One on One Conf.
6/18
JP Morgan European Conference
6/26
Credit Suisse Healthcare Conference
7/1
Morgan Stanley Healthcare Conference
9/9
Bank of America Merrill Lynch Healthcare Conference
9/17-19
UBS European Conference
11/12
Stifel Healthcare Conference 2014
11/18
Jefferies Healthcare Conference
11/19-20
Oppenheimer 25th Annual Healthcare Conference
12/10
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I've read about him for a couple years now and while his reputation is certainly as Terence Moore writes the other day when he was CS by the Braves backup catcher I noticed his stolen base percentage isn't really that good (10sb 5 CS). Unfortuantely I haven't seen him play yet which sounds like I may not being fully appreciating his speed just going by SB percentage.
Interesting stat on number of active biotechs
Ron Leuty @rleuty_biotech tweeted this. Would have thought (perhaps just seems like) more new in the period.
Between '08-13, 180 biotechs acquired or died, 86 new listings in same period; now 300 active biotechs #Allicense2014 @LifeSciencesLaw
ITMN:
Pirfenidone peak sales vary widely if you want to see a pessimists view see what Jefferies (Eun Yang) has she has been consistently negative on the company every since I followed them and she was covering them has peak sales at 650M/$300M (but notes not conservative assumption)! Terence Flynn (Goldman) models peak sales of $1.3B based on a projected price of $75,000.
http://seekingalpha.com/symbol/ITMN/news
Ones I've seen are consistently at/near 1B they vary on how quick it gets there and some were before BI data was reported positive. IMO 1 Billion is quite realistic and 2B may not be unreasonable either. While EU sales are slowly rising keep in mind Tracleer (a Billion dollar drug) did not ramp at a much different rate. It'll be interesting to see how EU sales ramp in the coming quarters with the latest Phase 3.
ITMN / Actelion:
I could see the logic of the deal (they are in PAH, generating a lot of cash, poor pipeline, etc.) but my guess is NO on this one. Since I think that I'll probably be proven wrong. Actelion management has been critical of Pirfenidone (granted it was likely posturing when they were developing Bosentan for IPF) and I never thought (top management at least) understood IPF.
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