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KevGee and crossing fingers for all of us:)
agreed, AVI, glad you had a chance to check the link on ICER that I posted. I think all bodes well for AMRN here with the low NNT and thanks for your thoughts on TOTAL EVENTS rather than first, looking forward to some interesting new data next month....
I wanted to pls ask your statistical thoughts on PRTO, I am invested here and I can't understand why street is so negative when powering looks good now and all they need is to hit same outcome as their first failed ph3. See the PRTO board with recent discussions between me and Kiwi and would love your comments there if you get chance to look at the data/stats plan? (off the AMRN board, sorry for posting this here wont let me direct message you)
thanks
acka - AKCEA Therapeutics. I looked at this after seeing the data presented at AHA. Really strong/interesting data via AON on Lp(a) but once looked into the terms of the deal first with Ionis and now Novartis, couldn't really get comfortable with regard to the ivnestment thesis for ACKA. data looks very good though.
Ohhh sonam do tell.......
agreed cant believe people pay such a service any credence, novartis huh? weren't top of my list either
of course Raf CVR is possibility
haha Sam that was a really funny pump fake! Thanks as always for posting...
As I said before when people were panicking in December and Kiwi called the low, we would see the move in scripts only in Feb:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145619674
Anyway on mrmain's poll which is great to see all the opinions, I am in two minds. A lot of optionality right now, do they do a massive (circa $1b) upfront ex royalties in EU and then keep USA for themselves AND market DTC like mad.... I think the delta at the moment is too big and potential acquirer will want to also see the label 135mg ? or 150mg? , get through adcom, see the early sales uptake/ramp with their new ex Kowa salesforce and also potentially see what happens with Epanova and whether it will be a class effect and V will end up having a competitor or not.... I don't doubt there will be interested bidders but I think the bid offer is just too wide at this point to really speculate but who really knows.... One thing for sure is AMRN has a lot of options at the moment, I hope JT and the team keeps on executing
with pleasure... don't know who that is or if I would be relying on the opinion of a an anonymous poor grad student just because he called the first trial failure :) Anyway I have done my work and will let the chips fall where they may.....crossing fingers.
underdog becomes a favourite...
$AMRN joined big leagues, became one of "50 stocks that matter most to hedge funds" ranked by # of funds holding it as top 10 stock. Typically this list is occupied by stocks like $MSFT, $BAC, $CVS, $DAL. Rarely seen a $5B+ Market Cap biotech name. Hedge funds have high hopes. pic.twitter.com/xqAqhCAflh
— HedgeMind (@HedgeMind) February 18, 2019
Good deduction skills Kiwi, I agree certainly the increase in study size is the only variable changed and imo bodes well but we shall see very soon...
can't open that can of worms, sorry but this is a good paper on biostats FYI:
https://link.springer.com/article/10.1007/s10654-016-0149-3
Good stuff Thanks sonam for interesting info -algae oil still more expensive input for V, liked the presentation on Peru too.
Sounds like I have converted you into a buyer prior to an even bigger binary than r-it lol
Have a diversified global portfolio...but nothing as interesting with very near term significant value catalyst..
love your advocacy - good work!
agreed I have looked at the data and I think its strong, your wife has a point. Of course there is risk and unlike AMRN anything times zero is zero in this case so >$200m invested and 12 years down the drain. classic biotech. But my view is it will hopefully crossing fingers work and if it does, will be used by everyone, will be covered, wont have any competition and will result in a strong value catalyst. all imo, DYOR.
Don't worry I remember your cautiousness in R-IT and how you missed the big move. :) But I will grant you that you totally called the total pessimism on the AMRN board a few months back and came in at a great time taking advantage of the sell off! That being said you should have been in it prior to the trial considering your own experience, JELIS and knowledge in the space.
On your points, I can understand you would have a view considering your previous loss in the first trial and this name. Did you sell or are you still holding? I think P values wont actually be marginal as trial now is over 600 patients almost double, so based on the stats plan we could be looking at <0.001 and <0.01 in patecty2. Also I think they even have a chance at hitting primary patency, although its not really relevant any more.... I agree with you they need BOTH secondary endpoints but these endpoints are really one and the same almost 90% correlation. Agree with you would be failure if don't hit both and or not going in same direction. But they did in patency1. All we need is the same result as before and its a win.
yes totally true its the ultimate binary and yes fully blinded and no-body including your wife knows who got vona or saline..... We will know very soon next month!
Very similar to Amarin where there was a great analogue JELIS.... In this case there was a previous ph3 that 'failed' but all we need is for it to 'fail' again the exact same way as this time the endpoints are the right ones!!
Only difference is that if R-IT failed AMRN wasnt a zero. In this case, if patency-2 fails PRTO is a goner. I think the odds are low though and am looking forward to the result like I was R-IT :)
Kiwi...in answer to your points:
1. I am an investor not a doc
2. Interesting point you raise about the length of fistula use. I think its interesting point you raise and I cant see any of this in the previously reported data but I am sure the company has been tracking?
My read is if it lasts past the 90 days (and surgeons didn't intervene to do balloon angioplasty) and it hasn't failed then it is generally a working fistula and wont be abandoned and will be used for life in general unless thrombosis? stenosis? So it is measured at say a year to see the difference between normal and vona and % increase. And that will dictate the success of vona.
I think surgeons are so attuned to intervening judging by all the balloon angioplasties and patency-1 failure so in this regard EVEN a minor improvement or difference and this drug would be used....
Good stuff Kiwi. Would be interested in her thoughts. I think you are right in that only a small improvement in secondary patency would be clinically meaningful and therefore it would be adopted widely. The market is big with no real competition and the trial is really setup to succeed. Only thing worries me a bit is surgeon variability...
One thing I think you may be massively underestimating is the price they can charge if trial succeeds and vonapanitase is approved. Because outside of the ESRD payment bundle and because of the massive pharma-econonic savings from avoiding second and third line grafts and central vein catheters which have big hard costs and poor prognosis...I think you should increase your price at least 10x. Management talking about 6-10k per application. Not sure why you thinking so low.....
Anyway let me know once your wife has chimed in. Big position for me.
Yes am aware of Avenu medical and ellipsis. Vascular access guidelines in the US and around the world recommend a fistula in the forearm (radio cephalic (RC) AVF) as the first access. The reason is that failures in the wrist/forearm can be followed by alternative forms of access higher in the arm, such as an AVG (Humacyte) or an AVF in the upper arm, either made surgically or with one of the percutaneous approaches (everlinQ or Ellipsys). In addition, a functioning fistula at the wrist/forearm is associated with the best outcomes. To that end, the trials conducted with everlinQ and Ellipsys from Avenu specifically excluded patients who were candidates for a RC AVF, and the technology is not suited for making a fistula below the elbow, hence their second/third line positioning. AVG’s, including Humacyte’s, have not been shown to offer advantages versus a functioning fistula, and therefore I think should be viewed as second/third line options.
Let’s take this off the AMRN board if you want? Would be keen to hear your wife’s views...
Kiwi... you should also check out vonapanitase from Proteon or ask your wife about AVF fistula patency issues - if she has had any with her renal patients...? I think likely a positive trial outcome next month. Essentially just replicating their previous failed ph3 trial with the right endpoint & statistical plan and solving for a big issue (secondary patency loss) in a potentially lucrative space with no competition.
Yes true agreed that’s what I mean their patients were enriched as you say therefore higher likelihood
AVII always love your posts, by far one of the best on here.
One thing to note is the type of patient they enrolled in STRENGTH:
2.Patient must be on a stable diet and statin therapy at least 4 weeks prior to randomization and meet the following criteria:
1.LDL-C <100 mg/dL
2.TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
As much as I hope your (and all our) dreams come true, this bodes well for STRENGTH. I think they will most likely will show some benefit.
for me totally not interested in vona for PAD! But hey guess it could be a bonus.
The market for radio cephalic AVFs's globally is big. If patency-2 is successful I would hope that they spend most of their time building penetration in radio cephalic AVF's primarily and then just licencing vona outside of USA.
what do you value co at if hits fredman? AND
what % level of improvement in the curves are you looking at for it to be considered clinically meaningful?
Good move in Nippon Suisan today, upgrading its 2019 guidance. hmmm I wonder why! :)
Nippon Suisan Kaisha Ltd. (1332.TO)
Tokyo
Nine Months Ended December 31
GROUP 2018 2017
Revenue Y543.26 bln Y512.09 bln
Operating Profit 19.90 bln 20.40 bln
Pretax Profit 22.81 bln 21.14 bln
Net Profit 15.27 bln 16.37 bln
Per share
Earnings 49.06 52.57
Results are based on Japanese accounting standards.
(END) Dow Jones Newswires
February 04, 2019 23:00 ET (04:00 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Nippon Suisan Kaisha Ltd. also released the following forecasts:
GROUP Year Ending
Mar 2019
Revenue Y706.50 bln
Operating Profit 22.00 bln
Pretax Profit 23.50 bln
Net Profit 16.00 bln
Per share
Earnings 51.42
Results are based on Japanese accounting standards.
(END) Dow Jones Newswires
February 04, 2019 23:00 ET (04:00 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Anyone follow this co?
Anybody invested here for PATENCY 2?
I think this looks very interesting.
Surprised such silence on the name considering results so close.
If true and this is actually a close relation of Adam Feueurstain that owns the dietary supplement co being sued by Amarin that is nuts!
BB you are often just so very inaccurate. You may be passionate, but I think most people realise you are just totally over the top with some of your ridiculous assertions.
It says very plain and simple in HCW's numbers their peak sales estimate is $3.678bn in 2029. Where do you get $2.193bn from I wonder sometimes if you are just so lost in your own mind of confirmation bias or you are purposefully exaggerating...
PS I wouldn't pay too much attention to HCW's financial model, while they are great on the company (their thoughts copied below), they cant even get the fully diluted share count right!
PPS - Tasty/PE - interesting comments on Epanova trial enrolment if I understand correctly.
COPIED BELOW FOR ALL:
Highlights. We hosted a management breakfast last Tuesday (January
8, 2019) in San Francisco during the JPM healthcare conference.
Following the company’s announcement of preliminary 2018 sales
of $224-228M and 2019 revenue guidance of approximately $350M,
investors had a keen focus on the issues around the commercial
uptake of Vascepa post American Heart Association (AHA), and the
conversations on the business development front. Herein, we highlight the following takeaways from the event.
Real-life physician feedback post AHA. Management noted that the
majority of physician feedback post AHA was positive towards Vascepa, and the debate topics for a minority of physicians generally fell into two categories: (1) physicians in the “lipid” camp who believe that everything should be explained by lipid levels. They have concerns for the validity of the REDUCE-IT results given that the magnitude of clinical benefits
could not be solely explained by the reduction of triglyceride (TG) levels. Management commented that although they were not trying to “throw away the triglyceride theory”, they believed that TG was only part of the story, and Vascepa had a multi-factorial effect on the cardiovascular (CV) events. Management noted that these physicians are coming around to appreciate that fact; and (2) concerns around the placebo arm of mineral oil only came up twice during the physician interactions, and in general this was not a significant issue in the physician community.
Most doctors believe that the high-volume usage of mineral oil is not a concern (used commonly for constipation), and the LDL increase on the placebo arm was more likely a regression to the mean. Additionally, most physicians do not think that there is a lot of substance behind the placebo argument, and the statin change cannot explain the 25% of risk reduction. On a separate note, the company noted that anecdotally, the clinical centers are losing patients who are on the outcome study of Epanova (by AstraZeneca (AZN; not rated), read out in 2020 per protocol) to Vascepa. We think that the competitive landscape may have
partially fueled the bear arguments against Vascepa.
What goes into the assumptions for the 2019 revenue guidance? Admittedly, management had limited insight into the
guidance and the honest outlook for the 2019 revenue was “we really don’t know”. According to the company, the revenue
guidance of $350M or about 50% YoY growth was based on the initial feedback from the market (2 months of promotion),
bottom-up analysis, physician calls and surveys as well as some educated guesses. Since the label expansion is not approved
yet, it is also unclear how that may impact sales upon approval. In addition, the off-label promotion has not done to this degree,
and the company is creating a new space for a new treatment paradigm with many unknown factors. As a result, management
was “really flying a bit in the dark” in terms of revenue projection. Due to the seasonal donut hole headwinds in 1Q19, the
company thinks that 4Q18 sales are a good starting point for modeling purpose, and believes that 50% YoY growth is achievable,
and that final sales could exceed the guidance. Another key factor for the revenue guidance is whether the FDA would approve
the sNDA faster than the normal process. The company plans to submit the sNDA by 1Q19 and assumes the base scenario of
a normal approval timeline. If an accelerated approval occurs, this could positively impact revenue. Importantly, the company
also has plenty of inventory on hand to satisfy the anticipated increasing demand.
Thoughts on the ramp-up of Vascepa. We highlight the following commentary from management that we believe would guide
investors thinking around the ramp-up curve of Vascepa: (1) there are limits to the extent that the company can promote the
off-label use of Vascepa. Although the paper publication of the REDUCE-IT study in the New England Journal of Medicine
(Deepak Bhatt et al., Jan 3rd, 2019, N Engl J Med 2019; 380:11-22) should facilitate the sales force with physician outreach,
the commercial activities may be handcuffed by the off-label status. As a result, the company is focused on getting the sNDA
submitted and approved, and should be in a better position to promote Vascepa to the general public following approval;
(2) although the physicians at the AHA were overwhelmingly positive about the REDUCE-IT results, the translation from the
enthusiasm observed at AHA to the uptick in Vascepa sales was not straightforward. The AHA audience was educated and
well-informed; however, they do not see that many eligible patients. The company identified the cardiologists as a key physician
group, and they added 4,000 new target physicians to the list. Management noted that a major challenge in selling Vascepa
was to get physicians to take actions. Physicians normally do not bring in patients, and patients, typically only come in once
or twice a year for a 15min general issue check (i.e., lipid panel). Even if physicians recognize the need and see value in
Vascepa, they may not change their medical practice. A key goal for the sales force is to change physicians’ prescription
habits, which could take a while to achieve (community doctors do not change quickly). The company noted that the 400
sales representatives in the field (activated earlier last week) would look at heavy/active prescribers, and would increase their
frequency of calling to encourage the physicians to change their practice habits; and (3) management noted that the first year
commercialization of Vascepa, post the REDUCE-IT results, would not be over-expanding based on the recommendations of
two leading, independent firms. Therefore, the company expects a relatively slow YoY ramp-up in the beginning. However,
management believes that Vascepa has a strong long-term prospect that would grow over the next 8-10 years, and harbors
great confidence in Vascepa to achieve billions in sales. We note that Vascepa is likely to be indicated on top of statins.
Approximately 50% of the target 50,000 physicians prescribe statins. Management noted that even to get 10% of those
physicians, Vascepa could reach billions in sales, and getting 30% of those would be considered a homerun for the company.
Thoughts on the business development front. Another topic of interest for investors was around possible business
development opportunities for Amarin. Management noted that they could not completely control whether they would work on
their own or part of someone else in the future, and they elected to focus on getting the label expansion and commercialization
of Vascepa. The company believes that it could sufficiently address the U.S market opportunity with adequate scales of
manufacturing and commercial infrastructure, and expects to expand its sales force after the label is amended. Management
views the EU market as the first likely partnering scenario (several inquiries for the EU rights occurred at the London conference
last year), and the ongoing negotiations are partially affected by the political environment. In addition, the company is discerning
whether it makes sense to seek partnership ahead of FDA/EMA approval or afterwards. The company could potentially achieve
better deal terms, and greater flexibility after an approval is obtained. Additionally, management noted potential partnering
opportunities in China. With respect to acquiring assets, the company commented that in the future they could become an
acquirer. Much like Biogen (BIIB; Buy), Amarin could have its core central assets and bolt other things on along the way.
However, management believes that it is not their near-term focus and priority. As of now, the company is focused on one of
the biggest untapped markets and ensuring the commercial potential of Vascepa is critical to the company’s success.
Valuation and risks. Our PT of $51 is based on equally weighted average of: (a) $40.73/share, as a 25x multiple of taxed
and diluted FY29 GAAP EPS of $6.59 discounted back to FY19 at 15%; and (b) an NPV of $60.70/share (discount rate 10%,
growth rate 2%). Risks to our investment thesis and target price include: (1) Vascepa commercial ramp-up and/or peak sales
not meeting our projections; and (2) further competitive disruption of the omega-3 market by branded drugs or generics and/
or OTC supplements beyond our model.
great find AND post AVI. thanks
Are you sure? My understanding is that if they become aware of MNPI plan can be cancelled. Is this not the case for Amarin ?
Agreed - should have scrapped guidance altogether. We know the 50% growth off label wont be enough for most. Reality was always label first and then re-contracting with payers into 2020. Huge uplift won't come until this is done imo...
Cool that you went to the AGM. Talking about this JOE guy, I wonder how involved he is with management, strategy and the board still? It annoys me that he just sold most of his shareholding prior to the low-ball 2019 guidance and with some time to expiry. While JT obviously did nothing of the sort (that would be very concerning), these 10b5-1 plans give directors ability to sell assuming they are not setup with any material non public info on hand. Problem is these plans can also be a bit of a cloak and be setup a mere few days before execution and nobody knows the exact details of this as all are confidential...we have seen that all before with Amarin and Joe back in 2012...
interesting link btw of doc calling Vascepa the "bellweather"
https://www.biopharmadive.com/news/esperion-bempedoic-acid-daiichi-license-cholesterol/545236/
Vascepa is going to be a big drug, only a question of time.
By the way anyone besides TTE, HDG actually done a detailed DCF model on Amarin? Good to compare notes on the post label ramp?
Don't worry, it cant be too long before the screenshot of some technical point being crossed and that he has re-entered :)
have to say I do still like his illustrations...
Have to give you credit where credit is due. Even if you are sometimes over the top, I respect your dogged persistence.
Have you ever thought about formalising your written complaint in a document to the regulators and then getting hundreds of signatures in a sort of petition. I am sure you would get plenty of signatures from shareholders on this board. I would be happy to sign... perhaps it would spur the regulators to make things right...
Great point bfost, totally agree and this is the biggest issue management are facing now, basically THE "CLASS" EFFECT due to the nature of the system even though they have the successful outcomes data.
If only docs, insurers, formularies, guidelines etc could be UPDATED immediately. Its sad that the system doesn't work so quickly. All of this will take time. But alas - it will happen.
And when it does Amarin's scripts will start to move and at that point its very hard to see them remaining independent. Partnering EU now would be a mstake imo.
nice work bfost, best wishes!
Thanks and agreed - question is how many multibillions, this is still a big question mark.
unfortunately not all docs are clued up like you, docs change their habits slowly, but I agree it will be embraced in time.