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Devil's advocate for STRENGTH - I recall seeing a post here recently that Epanova raised serum EPA in Evolve higher than at least one of the trials for V. Not sure how that would work, and I agree STRENGTH is likely to only read out with modest benefit at best, but something to consider... maybe someone else has more info to opine on that.
Ha, no problem there, this is the only channel I get. ;)
TTE- bookmarked this post with intent to revisit after some reading.
While I don't want to get my hopes up, I am highly intrigued at the possibility of early stoppage for EVAPORATE.
If that's possible sometime in the neighborhood of next month, I can't help but wonder if the Co has that possibility in their minds before starting any serious negotiations for pship or otherwise.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5282870/
Recently, the Combination Therapy of Eicosapentaenoic Acid and Pitavastatin for Coronary Plaque Regression Evaluated by Integrated Backscatter Intravascular Ultrasonography (CHERRY) study investigated the effects of Epadel 1.8 g/day with pitavastatin 4 mg/day versus pitavastatin alone on the progression of coronary plaque via integrated backscatter intravascular ultrasound in approximately 200 patients [54, 55].
After 6 – 8 months, total plaque volume and volume of the lipid-rich portion of the plaques were significantly decreased in the EPA arm after adjustment for confounding factors. Specifically, the percentage of patients with plaque regression was significantly higher with EPA versus without EPA (50 vs 24%, respectively; P?<0.001) [55]. The change in the EPA/AA ratio, which was, of course, significantly increased in the group receiving EPA, correlated significantly and inversely with the change in plaque volume (r?=?-0.332; P?<0.001).
These improvements in coronary atherosclerosis corroborate the decrease in cardiovascular events in JELIS and suggest that EPA may reduce the residual cardiovascular risk in patients with prior CHD who are already on moderate-intensity statin treatment.
Thanks for sharing, I'll add the Top 20 Pharmas by Cardio Sales, according to PM Live.
http://www.pmlive.com/top_pharma_list/cardiovascular_revenues
2016 (actual)
2018 (forecast)
There's a thread with Herper on Twitter that provided me much better insight into the MO issue, which is to say I am not sure it was an MO issue at all.
Matt said there's a school of thought among Cardios to approach drugs as a class, and more or less treat them the same. Where so many other FO trials have failed, why did this one succeed, and so robustly? (Obviously we know why.) But MDs who have done a lot less research that most of us re: EPA, still want to treat them as a group of failures, with one large but skepticism-inducing success, which leads to the need to point a finger at something.
Well, it must be the MO, or whatever the argument of the day is.
My heart wants to see Nissen eat it and STRENGTH to fail, but my head thinks we would benefit greatly from a modest benefit to help bring credibility to the "class." Sadly, apparently JELIS and R-IT are not enough to get **everyone** on board, but we'll see how the next 2-3 months go... they might all get left behind on the wrong side of CVD history.
After listening to the webcast this morning I am curious to get the hive mind's opinion on what a Euro pship/sale does to buyout prospects.
Car guy here, so I am thinking of it like giving up a bit of top end for increased acceleration off the line. A nice cash infusion could also be the catalyst that quickly gets us to the BP offer window (for US rights) I bounced off danfromchicago last night?
Dreaming of that wonderful land where reasonable premium can close the gap to a pps where JT is willing to take the money and run.
Disclaimer: I know others want to GIA and wait for Amarin to buy PFE (kidding) but I am not in that camp.
Thanks for the reply. I also agree that any BO is going to execute on a pps several multiples higher than where we are now. Say $70 minimum, for the sake of argument only. I do think this opportunity is worth more than 100% premium on $35, but again for the sake of argument only, we need to be within a few dollars of $35 to open up that "offer window", so to speak.
The question then becomes, what gets us to 35, and it's probably a combination of those catalysts and others we haven't thought of. One way or another it's going to be (even more of) an adventure so hang on tight!
GLTA
Dan, I second Smarterer's reply, really appreciate your insight into how the other side works.
One thought I had, feel free to opine... Everyone and their cat knows AMRN is a prime, obvious, no brainer BO target. Adam even hit on this after speaking about the "blemish" for 30 paragraphs. (In multiple articles. Lolz. That guy.)
With so much potential upside, I feel like it won't be long before this thing is like 100 acres of dry grass which hasn't seen water in months. One spark, the whole thing goes in the blink of an eye.
It's this reason I don't think Baker Bros would sell, and are more likely to let the dust settle, help put in a new floor, and then put out another 13F showing they added even more shares. (We had a big day the last time they did.) Maybe scripts start to ramp over the next 8 weeks showing doc adoption, or there's another surprise catalyst. Price climbs, and once we get above a certain level (say $35+), we are in that golden range where the premium can close the gap to (more) accurate value... it's there where I think the grass is dry, and the rumor sparks can come from anywhere, until one of them is legit...
Even today with FUDsters throwing anything against the wall to see what sticks, be it MO or JT's 10b5-1 exercises/sales, people were wondering if the REGN mixed shelf means they are prepping for M&A.
I think we're down, but it won't be for long. AMRN is Tim Duncan out of college, aka The Big Fundamental. Proven results, amazing cost/benefit, no drama (at least in terms of side effects!), massive market, ok my analogy is breaking down, but you get my drift. In my years of investing, knowing the R-IT data, this is the no brainer of all no brainers.
Curiously REGN filed a mixed shelf today, which apparently no one expected or understands (at least on Twitter).
https://www.sec.gov/Archives/edgar/data/872589/000110465918067924/a18-39915_1s3asr.htm
https://www.nasdaq.com/symbol/regn/financials?query=balance-sheet
They are neither Top 10 Overall Sales nor Top 10 Cardio Sales, but it's interesting.
https://www.igeahub.com/2018/07/24/top-10-pharmaceutical-companies-2018-cardiovascular/
But they do sell Praulent, a PCSK9... https://www.regeneron.com/praluent-injection
And a drug for macular degeneration... https://www.regeneron.com/eylea-injection
I commented on this as well, link below. I personally think he was just capitalizing on the moment for views and traffic, but it's still trolling, even if he does end with BO talk... ie I amputated your foot, but don't worry, you'll figure out how to walk again soon. And be running in no time!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144839881
I thought today's article was interesting in the sense that it was coming out of both sides of his mouth...
Mention mineral oil in the headline and then 3x in the first 7 sentences. Call it fish oil another few times, call out the retail following, etc. He loves to push our buttons, that's for sure.
Then shift gears into the company almost certainly being sold at some point, AMGN yadda yadda.
But wait, I thought we had some big problems to iron out first? GMAFB. That guy.
I am not onboard with conspiracy theories. I think he does what he does to get attention, page views, and maintain his "relevancy" to keep getting a paycheck. He's got 1 or 2 kids in college... can't be cheap!
And why another article today? What changed that he forgot to include Saturday? And then time it precisely to coincide almost exactly with JT's TV appearance? I could go on, but I won't...
if I recall correctly
The day after we learned Baker Bros basically 2x'd their stake we were up >10% IIRC.
Because it's Adam Feuerstein. He got no love as a child and for some reason he takes it out on biotechs
Endo, for those who it may not be clear for, that $2B number you use is monthly, not yearly revenue.
Low, Did you take the picture? Look forward to your observations and thoughts on what you see this weekend.
Vascepa in the house at AHA. Exciting. You can see where they’re going with this as they set-up. We have lift-off! $AMRN pic.twitter.com/mXr3IzsQbt
— TerraPharma (@TerraPharma1) November 9, 2018
Nope, I do not personally think anything of the sort, but if there was no doubt out there AMRN would already be $30, $35, or more based on conservative estimates of sales.
I'm not being critical, relax. Having a ton of remaining doubt out there is a GOOD thing, because it means that AMRN is not "priced to perfection" right now.
Looked at the AHA live stream schedule and noticed the discussant will be covering both R-IT and the Omega-3 portion of the Vital trial. Doesn't he only have a very short amount of time? Less opportunity to "poo poo" our good results? Maybe a quick compare/contrast of these O3s?
Late Breaking Clinical Trial: Answers to Critical Questions in Cardiovascular Prevention
Moderator: Barbara Casadei
The VITamin D and OmegA-3 TriaL (VITAL): Principal Results for Vitamin D and Omega-3 Fatty Acid Supplementation in the Primary Prevention of Cardiovascular Disease and Cancer- JoAnn Manson
Discussant: Vital D portion of Trial - Jane Armitage
The Primary Results of the REDUCE-IT Trial - Deepak Bhatt
Discussant: REDUCE-IT and VITAL OMEGA 3 portion of 1st Trial - Carl Orringer
Ezetimibe in Prevention of Cerebro- and Cardiovascular Events in Middle- to High-risk, Elderly (75 Years Old or Over) Patients With Elevated LDL-cholesterol: A Multicenter, Randomized, Controlled, Open-label Trial - Yasuyoshi Ouchi
Discussant: EWTOPIA75 - Jennifer Robinson
Cost-Effectiveness of Alirocumab Based on Evidence from a Large Multinational Outcome Trial: the ODYSSEY OUTCOMES Economics Study - Deepak Bhatt
Discussant: ODYSSEY (Cost) - Andrew Moran
Panel Discussion
Speaker(s)
Jennifer Robinson
Andrew Moran
Deepak Bhatt
Barbara Casadei
JoAnn Manson
Jane Armitage
Carl Orringer
Yasuyoshi Ouchi
AHA Discussant
Great post thank you for sharing your insight.
TTE and the stats crew, holy hell, you're amazing. Thank you for sharing your knowledge, predictions, guesstimates, and humor. Truly appreciate it, whether or not I can wrap my head around all of it!
Whatever you think of Bill Ackman (not much personally, but he's made and lost a whole lot more than I have), I think it was he who said "to be early is to be wrong." I apply that proverb to my thinking pre AdCom whenever I need a good humbling.
But in terms of options, IMO near term are for OTM lottos or same day trades only.
In descending order of size, I'm long a good deal of shares, Dec/Jan/Mar 20s, Mar 22s, Mar 35s, and Mar 39s.
My goal is less material and more about time. Want to drop the f/t gig and spend more time with my daughter while she's still knee high to a grasshopper. That's the dream.
"Dr. Harlan Krumholz of NEJM Journal Watch Cardiology commented: "It is important to remember that this is an announcement — there is no presentation, preprint, or paper yet. But the findings are exciting, unexpected, and provocative — and have raised great interest for the release of more information at the AHA Scientific Sessions."
Good thoughts, thanks for sharing. The time cost taking away from AHA prep is not one I had really considered. Wonder how they would handle interested parties though? If AMGN is beating down the door, not like you're going to blow them off, you know?
As far as how strategically management planned this out -- they certainly had plenty of time to think about it! Hopefully they used that waiting period to game plan the different scenarios depending on quality of data, and this is the one code named Operation Money Tree. ;)
We already know results are good, or at least, so-so at minimum. 3-to-22! Market approves! With 25% RRR "good" is highly likely and underwhelming is less likely, ie good is now more or less priced in. So I can't for the life of me understand why they didn't already do a raise unless they know another climb is in store. That's not to say they can't do a slow or maybe even decent ramp w/o, but I think so many expect it, they are essentially limiting upside until they do it, outside of M&A coming in first.
IMO Saturday is about two things -- stat sig CV Death and new findings about subgroups. Significant market re-pricing is all about surprise, and I have a strong feeling something unexpected is coming in one or both of these categories that will require another big adjustment.
I don't know much about the dynamics of the relationships between exec leadership and PIs, but I can't help but wonder Bhatt and JT came to an agreement that "if X is stat sig, let me tell the world at AHA" or something similar.
I may have completely backed myself into this logic based on the result I want to see etc, but having thought about little else the last several weeks (and years) my feeble mind keeps going to this same conclusion.
Ha! Yes exactly. JT is holding all the cards, and only he (+ those in the loop on data) know how good they are, which controls the next turn in our adventure.
One thing I know for sure, it's not going to be a perfectly smooth climb out to 30,000 feet, so buckle in and hang on.
While possible, it all depends on the stuff we don't know, ie the data. If data is so-so or good, maybe they will take a pps that is currently within the realm of reasonable premium. Eg if pps is 25, I have a hard time seeing any BP justify more than 60 to their own shareholders in a perfect blue sky scenario.
But I DO NOT think that's the case, and from all the cues, I think data = cvd earthquake ~ 7.0 on the Richter Scale. Which is also why I think the team have adopted the strategy they have:
PPS = $3
Release a big juicy tease in that top line number
PPS adjusts violently upward in first phase of move toward accurate pricing
PPS = low 20s
Wait for market to adjust to "new normal" ;)
Don't raise because you know you're going higher
AHA = everything changes
PPS = adjusts again to Mambo #5 scenario???
Now do your raise to remove overhang with smaller dilution (shareholder friendly!)
Act like you're GIA until one of the Big Boys pulls the trigger
I also think over the next decade this will be a very politically friendly drug to market. Demand for a relatively low priced solution, combined with big time prevention characteristics, means insurers, reps, docs, suppliers, and accountants at the acquirer will all be sitting pretty.
If there's one thing JL and this process have taught me, it's that I lacked a bit of imagination here. Full mea culpa on my original 15-18B buyout guesstimates. This ought to be in the top 10 drugs sold annually and while it may take time, I believe the market will see this fact at some point in the next 6 months.
24 32 72 100
caveats:
- 72 puts us at a ~ 22B mcap, which is totally reasonable if cvd ss and the sentiment accurately reflects the "paradigm shift"
- great assumes spectacular #s w/ cvd ss
- eoy assumes above spectacular #s, capital raise at some point with overhang removed, and no pships preserving M&A speculation
- i think the tweet today from amarincorp was a heck of a tell, and is likely influencing my rosy numbers
- the more i think all this out strategically... we all want to read into the lack of a raise up to this point, but have to also consider that this is one of the biggest possible stages to release info, so unless they want Dr Bhatt to get out in front of underwhelming numbers (which doesn't align with the lack of a raise to date), there's no logical motivation to release so-so data on a big stage and disappoint all the pent up interest and hype
- most importantly, science... we know the science is on our side
Love this idea
Some profit taking at that point should be a given. Wouldn't be surprised to see a significant pullback as speculators sell to the tutes while the dust settles. Keep in mind this is when everyone expects a capital raise, if it's going to happen. If that overhang is removed BO spec will come roaring back -- heck even if not removed BO spec should come roaring back.
Best thing you can do is to have several game plans ready to execute based on the different scenarios.
Apologies if this has already been posted here ad nauseam, shared by TerraPharma tonight on Twitter here:
A primer on prescription EPA & a nod to JELIS: "primary prevention for 2 composites of “hard” endpoints, coronary death or MI, & fatal or nonfatal MI,
— TerraPharma (@TerraPharma1) November 4, 2018
were decreased by 22 & 23%, respectively, comparable to that of primary composite endpoint of 19%" $AMRN https://t.co/n44hS0AFtD
Of the secondary endpoints evaluated, Epadel significantly reduced risk of unstable angina in the entire study population (HR, 0.76; Brinton and Mason Lipids in Health and Disease (2017) 16:23 Page 3 of 13 P = 0.014) and in the secondary prevention cohort (HR, 0.72; P = 0.019) [36]. Although the largest numbers of patients with primary endpoint events had “soft” endpoints of unstable angina (n = 340) or revascularization (n = 413), which may have resulted from bias due to the open-label nature of the trial, it is important to note that primary prevention for two composites of “hard” endpoints, coronary death or MI, and fatal or nonfatal MI, were decreased by 22 and 23%, respectively, comparable to that of the primary composite endpoint of 19% [36]. This strongly suggests that the positive finding of cardiovascular disease event reduction in JELIS was not an artifact of the open-label trial design.
The "192,000k > 192k" post almost made shoot water out my nose.
What about the poster here with $38MM in share value (at the time of posting, a couple weeks back I think)? Pretty sure that takes the cake.
From Twitter:
"Jefferies out after hours with a positive note on $AMRN - taking pt to $30 from $15 , sees AHA 2018 Meeting on 11/10/18 as a key catalyst in the near term"
Well, duh.
Unsure about Crohn's specifically, but I have a history of IBD (which I believe is actually mild ulcerative colitis) that EPA appears to have had a big impact on. Anecdotal, n=1, ymmv.
Missed the call so thanks for the summary.
I don't disagree at all. I planned on changing GPs for reasons outside of this, but this has added fuel to the fire. (My wife and I go to the same doc and she handled a situation with her very poorly.)
I'm also a relatively new father (11 months) so time is in short supply. Excuses, excuses, but I don't plan on taking the OTC stuff forever. Maybe I should just load up on pizza for a couple weeks before my physical! Get those trigs up! ;)
Same boat here, as a shareholder that would prefer to take Vascepa, my current GP has yet to be convinced, despite her acknowledgement of my sound logic when making a case.
Taking 1.5g of Pharmepa Restore Pure EPA daily for now.
Also talked to my dermatologist as I've seen profound results in control over my eczema, but she doesn't feel comfortable writing outside of her standard area.
Plan on talking to my GP again at my next physical in Feb. I believe I have mild ulcerative colitis that is also brought under control with 1.5g daily EPA.
Pretty remarkable, this stuff...
As a long time fan of your posts, not sure I can be a fan of this one. Seems broadly and unfairly exclusionary?
Not sure who this post is directed at or why, but for what it's worth, my account is new, but I am not new to the board. I posted prior to the AdCom fiasco, but forgot my old login info and stopped using the email associated for user/password recovery. After that I needed to walk away for a while, but I continued to follow the stock and wanted my revenge, going long again back in July ahead of top line results. I have parlayed 2/3 of my initial gains into options, essentially betting the farm on what I perceive as a once-in-a-decade (or more!) opportunity.
I was also responsible for the patent spreadsheet linked at the top of the main page, if that gains me any purchase of cred in the community.
Again, many here lurk and fewer speak up, but most are grateful and appreciative of your posts. I hope that post-success, things here continue to be generally positive, informational, and supportive of everyone who wants to contribute or just sit back and learn.
Strategically I think the way the company is doing all of this is extremely smart, and offers the best shot at the highest/most accurate pps, relative to the presumed size/quality of the gold mine we have here. Especially since we are coming from sub $3, recent pps obviously matters psychologically.
I could be entirely wrong, but if you had paradigm-shifting news like this, why blow your proverbial load all at once? Getting one supported rise in pps and then relying on takeover spec for the rest of any increase you want to see?
Instead, release top line, then wait. While waiting, no secondary offering becomes a signal itself. Simmer for 6 weeks while market adjusts to new pps. With this new valuation base to work from, release the next wave, rise again.
Especially if they want to get HIGH dollar for a BO, any acquiring Co is going to have to justify the premium paid to do a deal. I've had $50 in mind as a very conservative floor for BO, but assuming the data is as good as some of these presentation headlines imply, that floor will have to be raised.
Some of you will certainly say that it should be triple digits, and you may be right longer-term. But to get there I think we'll need yet another leg of support like (massively) accelerating script growth showing doctors are aligned with the data, insurers drop to the lowest tier, and consumers understand the difference between OTC. (Given that Lovaza had a great run and is essentially the same as OTC EPA+DHA, I think the last one will be the smallest hurdle.)
My favorite part:
"This gets at the crux of this debate. If a company makes available the technical details of a product, but only after hyping the findings, and if the details undercut some of that buzz—is it too late?"
This reminds me of something said by my high school baseball coach, after I asked him a rather pointless "what if" question.
"Jeff, if my Aunt Tilly had balls, would she be my uncle?"
Perhaps this TDB writer should examine the logic behind what they're asking, before asserting such a dumb question.