Thanks JL, appreciate the info

AV, fine, you want to add statin-intolerant but otherwise statin-eligible to the population, I’m good with that.

Good point. Fact is, none of us really know, we are all guessing, but I do appreciate the dialogue. We all get to conclusions in our own way. However, this board truly affords the ability to sound out your assumptions with some really smart people who have different perspectives. At the end of the day, this will now be all about revenue ramp, so time will tell who is right, but we will all likely be richer than we are now. Best of luck to us all.

Ha, pax33, I appreciate all views, but you’re right, your comment doesn’t change my view because you miss the point. I’m “fixated” on the label solely because I’m trying to create a conservative perspective of eligible/probable population. The conversation started around my contention that the eligible population must first be on statin, as per label, and of all the restrictions, this one was likely to stick. I never said you couldn’t work around the label to Rx without statin. What I’ve maintained all along is that I don’t think most doctors will do so since there is no study-based evidence supporting this. My previous posts explain this clearly so I’m going to leave it there...

As I said to sts66, I do think docs will prescribe wider than several of the restrictions, but the one restriction I think will stick is statin use. I could see DM+statin and forget the extra risk factors, or statin user plus high trigs and some risk factors but no CVD. I just don’t see dropping statin use as qualifier. The entire study is based on this underpinning drug. We all get the greater benefit as we are V diehards, but I do not see the average doc prescribing without underlying statin use. Why would they? The R-It results must presume a complimentary effect based on the concomitant use of statins and V. As I said, if a doc digs into the actual study, he/she will find nothing that supports use without statin. Unless the doc is a diehard like us here, or believes in the Evaporate results justifying standalone anti-inflammatory benefits, there is no justification.

I think we’ve just about beaten this horse to death lol, so we’ll just have to agree to disagree. The funny thing is I absolutely hope you’re right and I’m wrong. I just won’t base my future price and/or BO estimates on anything but a conservative measure. BTW, you are right in your assertion that many statin-eligible patients don’t take statins. A recent study concludes that only 50% of the eligible population takes statins. Just to stir the pot a little more, I’m going to assume that the take-up of V will be less than 50% as it is an added burden (cost, adherence) on top of statin use.

Sure. I’m good with that. The question is which one do you base your investment thesis on? ??

The funny thing is I agree with you to a point, as I do think docs will prescribe wider than several of the restrictions, but the one restriction I think will stick is statin use. I could see DM+statin and forget the extra risk factors, or statin user plus high trigs and some risk factors but no CVD. I just don’t see dropping statin use as qualifier. The entire study is based on this underpinning drug.

Sorry AV, I just don’t agree within the context of determining a base population strictly on the label. As I just said in a previous post, I think that’s a stretch. You’re hoping this language creates wiggle room so docs can prescribe for wider population, but you still need as yet uneducated docs to feel like we all do on this board, that V would be helpful even to those not on statins. Why would you pre-suppose that the average doc will prescribe beyond label, especially when even if the doc digs deep and reads the R-It results, he sees that the entire study population was co-treated with statins? I think it’s a good label, and I think we have more room to run, but I don’t believe we should be projecting wider population than label states.

C’mon, that’s a stretch. The question is strictly what the population is under the actual label. It’s beyond optimistic to suggest that the population is greatly expanded because there is a large number of statin-intolerant patients, or that this is wiggle language that will allow drs to circumvent this restriction to prescribe V to non-statin users. We’re trying to create realistic expectations as investors, not put on rose-colored glasses and create confirmation-bias perspectives. I hope as much as anyone that there is much wider prescribing than the label suggests, but in terms of creating a real base population number, I think you have to work within the restrictions.

Statin use is absolutely required. Amarin’s new label specifically states “...adjunct to maximally tolerated statin therapy”, plus Tgs above 150. All else follows from these two triggers.

Aren’t you missing the statin factor here? Eligible patients must be on statin, plus trigs over 150, plus: established CVD or DM with 2 risk factors.

Yeah, seems low, but maybe trying to take into account slow formulary updates throughout the year. Unfortunately the delay from Sept to Dec f**ked AMRN as 2020 formulary decisions have prolly already been made. From some research I did, seems like most insurers/PBMs revise formularies within 3-6 months of new drug approvals, or at least that’s their stated goals.

They’re too drunk. They’ve been drinking all afternoon lol. Give them time to sober up...

Yup, it’s right there in the announcement. Surprised we didn’t get >135, but still good news.

JJ, yes, I’ll retract the 6M, as that is the number of people currently living with ALZ (according to Alzheimer’s association), not the addressable population. However, it doesn’t change the timing issue relative to trials/approval/ramp versus remaining runway, and BP is not going to pay for this now in any way (they’d be crazy to do so). Also, it might be interesting to consider what an NNT might look like for this, as well as how an ICER might view its cost effectiveness, given that it may be difficult to narrow down the potentially addressable population. In any event, the potential of an ALZ indication doesn’t change my opinion on how BP will view/value it now, which is not much.

BTW,I would love to be wrong, but I’m just trying to be realistic.

The reality is the calculations can be as detailed as projecting every year revenue as it ramps, doing NPV by year, creating total NPV as per ramp, and applying discount rate to get to target internal rate of return, which is likely 8-10% in BP world. Or, they can chuck all that and say let’s just buy us some revenue lol, and where else can we buy 15B-20B in net revenue (giving some leeway that margin is 80%+) within 10 year window. So what if it’s not our target 8-10% IRR, it’s still a shitload of money we can reinvest to try and create other plays. And to your point and mine, they’ll put out a PR with made-up numbers that justifies the buy, and nobody will really ever know (who’s ever gone back and looked at individual BP acquisitions years later to see if they really panned out?)

New indication for Alzheimer’s will not extend patent life, and I can’t imagine they will get through necessary trials and FDA approvals in time to have enough time to ramp up meaningful revenue within remaining patent runway. Alzheimer’s population is only 6M, so you will need time to educate docs and patients, secure favorable ins coverage, and hope for meaningful takeup and subsequent adherence with a portion of the population that is obviously significantly challenged both financially as well as cognitively (as respects adherence).

These patents will only affect the combo manufacturing process itself, not the manufacture of V. Therefore, I still contend that this won’t increase eligible population, and generic V will be able to be taken in conjunction with these other drugs for much less cost. On the flip side, the simplicity of a combined pill may appeal to some patients, so they may opt to stay on V combo pill, and this may somewhat lessen the steepness of the patent cliff starting in 2029 (if the patented combo process is patented is hard to duplicate otherwise). However, I don’t think this will make a meaningful impact on gross lifetime revenue.

Funnygi2, I think that’s as reasonable a guess as any. I think Europe pop is actually 750M or so, double US. However, US statin-taking population is roughly 40M, or around 15% of pop. A 2013 CEDC report put European statin use at around 9% of pop, but that could be around 60M. And yes, V cost will be significantly lower in Europe, just don’t know how much lower. As for BO if your $50B is the right gross revenue, maybe it pushes to $25B? Anybody’s guess,

By other drugs, I assume you mean other indications? Think that’s way too unclear and too far down the patent runway to matter in BO value calc. As far as the combo pill, it won’t change the overall eligible patient population, so I’m not sure how it changes anything revenue wise (except maybe a boost in patient med adherence, which may improve from estimated 50% rate for chronic meds)

Couldbebetter, yup, well aware of the various formulas to determine value, whether NPV, DCF, etc. In this instance, just keeping it simplistic, but based on NVS own revenue estimates, the MDCO BO is a good deal at 16%, or even 30% of total revenue. Of course, there is no way to know whether their estimates will ever come true, or if they themselves believe them or they just published them as a PR move to make the deal look better and make shareholders feel better ??. Getting back to AMRN, no doubt they are completely de-risked after approval (assuming positive generics suit outcome), and given their high margins, which will be even higher for a BP with established, no cost sales force, it’s all about total revenue. BP will have roughly 9-9.5 yrs runway if a quick BO is accomplished, and hopefully formularies will adjust by mid year to reflect new label. Having said all that, I don’t think it’s overly simplistic to assume that even if V can do $30-40B over this period, who’s paying more than 50% of that to acquire them? (And that’s 50% before NPV, DCF or any other net value-reducing formula). The short runway makes me stick with the 15B-20B BO.

BTW, if they go GIA, while revs increase, multiples will decrease as the runway for their only product diminishes, so holding beyond a year or two without a BO will require a recalculation. If, and hopefully this isn’t the case, JT thinks he’s building his own BP and starts buying new molecules, watch out lol.

Exactly. 9.7B is 1.5x peak, and 16% of expected gross revenue. Neither number bodes well for AMRN (assuming 5-6B peak and maybe 30B-40B gross over 10 years, and that’s being generous). However, based on these MDCO metrics, if they are remotely accurate, I think NVS actually stole MDCO. Great deal at 1.5 peak and 16% gross term rev

Sorry, but at a 9.7B buyout price, there is no metric that makes this bode well for AMRN. Not peak sales multiple, not price to gross sales %. I’m very long AMRN, but I don’t see this as a good example. I still believe peak of 5-6B for V, and potential buyout maybe $15-20B, but I know that will many heads here explode lol. Flame away...

LOL! It’s what happens when we all get bored (or board, as it were) waiting for approval.

JL was asked to participate in a study regarding inflammation, and as such cannot communicate with shareholders. (Just guessing)

Yeah, same regarding impatience lol. I’ve tended to close out early as well, but this play really only maxes very close to/ at expiry. My only concern is getting hit with early exercise/assignment on the short call (the 20 strike). If share price soars, might get hit early. Never been in that position before and won’t have cash to buy the stock so will need to exercise my $15 strike long calls to cover. There will be some lag time in execution. Will my broker allow me to float the lag?

Part of my position is comprised of vertical spread. Mine is Jan2021 15/20 at $1.45 entry. Nice return and only need $20 share price at expiration ??. Wish I had built larger position in that spread before the recent run. Will build other spreads after I know what the label is.

Oppenheimer hit piece not unusual. Just like Morgan Stanley analyst Andrew Behrens continuously trashed RLYP with $10 PT when every other analyst was in the 25-45 range. RLYP got bought for $33. He was actually a highly ranked analyst and he still got bought. One “wrong” call for a big payday doesn’t change his life, especially if it was an internal request by his own firm.

sts66, posters on YFMB were accusing Nicholls of bashing results, but these quotes don’t seem negative. What am I missing? His comment about trigs and who wether other patients should be taking V seems to imply a broader patient population, no? Also, if the quote is correct, he clearly did not say it’s a failed trial (as some at YFMB stated). Again, what am I missing?

From FiercePharma re Evaporate (very favorable)

$AMRN AHA: Amarin's Vascepa halts progression of arterial plaque in key study https://t.co/M0zx0et8WS

— Sufoselat (@aveirodobraga) November 19, 2019

Exactly what I was thinking. Have to educate med community that it’s really not about trig reduction, rather, it’s all about reduction of inflammation!!!

GD, scratching my head here. Yours is the second reply today to a post I made back in June. Is this old post somehow popping up again? BTW, I don’t disagree with you, and as I said to JL earlier today, with extenuating circumstances like the Evaporate data, BP might just say f**k it, we need to buy this now at higher than typical multiple. My response in June was based on published historical peak multiples of BO’s at very high BO values. As you would imagine, higher multiples are easier to swallow at lower total BO values. When you get into the stratosphere of >$20-30B+, it gets harder to justify. In any event, I will be VERY happy to enjoy an atypical multiple ??

Well that’s not encouraging...

LOL! Good one BB.

Does anyone know if dementia rate is lower in fish-eating cultures? That would be a pretty big tell, no?

Odd, you seem to be replying to a post I made way back on June 6th. Did this just pop up again? In any event, I still stand behind the historical perspective I gave back then. However, I never say never, and if the market and/or BP actually figure out the potential given positive Evaporate data supporting pure plaque reduction, all bets are off. Btw, although we may have butted heads over the past year, I want to thank you (and many others here) for providing such compelling scientific perspective and helping me stay invested when I could easily have been scared off. Please accept my sincere gratitude. Regards, Jeff

Wow. What a story. But my Lord, what does this say about the FDA? How can their internal team be so negative, yet a hand-picked panel of outside experts near unanimously tells them they’re wrong? That scares the heck out of me, as it smacks of real incompetence and lack of expertise (or maybe integrity?) at the FDA.

JL, thanks very much for the reply. Glad to know that a DDI trial could be a fairly quick scenario. While It is my fervent hope that the MO issue is quashed at the Adcom, I guess there is some comfort in knowing that even a DDI request might only delay the inevitable another 6 months or so.

Agree that it seals the most expansive label, but it may delay approval. Maybe an ignorant assumption, (apologies if so) but since the EVAPORATE info comes out several days after Adcom (assuming that no one is privy to the data beforehand, including AMRN), if this data is submitted by AMRN after Adcom, wouldn’t this be treated as new info which would delay PDUFA (maybe even require new Adcom)? Separately, I don’t think this data helps at current Adcom, because in my opinion this info doesn’t override the MO concern, and I think the Adcom is about need to conduct DDI, not MOA.