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Some commentary:
https://twitter.com/TomSilver39/status/1674610336522174464?s=20
Also Auphie has hired the most respected M&A attorneys:
$AUPH retained Skadden, Arps, Slate, Meagher & Flom as their M&A law firm. The link below provides their Recognition. This firm has represented one of the two companies in virtually every airline merger. Their Recognition is beyond impressive.https://t.co/axFIMqE1Au
— Chip Munn (@ChipMunn1) June 30, 2023
I'm with you Jess, but you need to restrain yourself a bit. The balloon doesn't appear to have that much helium in it, as the stock price is still well below where it was a month ago.
Well now we will see if there is any interest or if they if butchered the rollout so bad that no one is interested.
It was pretty clear that PG was not going to make it past the next AGM, and it appears he finally realized it.
Envious of another BO this morning that is not us. But it shows what could have been. Again so many BOs come early and not years after drug
approval. Lilly buying Siligon Therapeutics and it is up over 700% this morning. SGTX.
Excellent post TalShu.
I have been wondering why Iljin wanted to remove those two slugs but leave PG in place. I was thinking that the idea behind that would be that it would make a BO a little easier to accomplish with PG in place. But we are not seeing much happening.
Agree with both of you and you make a good point Capt that China can be valuable in that it could make it more appealing for a BO.
So true PD. The generic in the US is only approved for VHTG, but is gobbling up scripts for CVD, so you are correct that the same will occur in China - except quicker.
Thanks Duke, appreciate all you do for the board. Such a hodgepodge it puzzles me why or how all these coverage decisions are made at all these insurers.
I just had a situation not related to V that forced me to make a call to Medicare. I got an EOB from BCBS this past weekend and they had a $7K charge for which they denied payment. I did not recognize the charge so I called them today. They said that it looked like Medicare fraud as the charge first went there and then sent on to my secondary insurance BCBS. So I then called Medicare. The charge was for some durable medical equipment - a catheter. I told them I did not ever come within 100 feet of a catheter and so they will start an investigation. Bad thing was that Medicare actually paid out over $5K on the claim so not sure why they forwarded the entire $7K on to BCBS. I am just wondering and concerned as to how they got my Medicare card number.
To be balanced, the poor overall market has punished a lot of small bios, so Auphie is no different.
On the other hand, scripts are stalling and there seems to be no plan (at least not elucidated or witnessed) to get things moving. Profitability no where in sight.
And that could be because the EMA has said that mixed omega-3 are not effective for CVD (and I assume any reimbursement for that has been withdrawn). Unlike the FDA or our moronic doctors here who pay no attention.
https://www.tctmd.com/news/european-regulators-strike-secondary-prevention-claim-omega-3-drugs
Thanks for all that work Capt. So you are estimating 89 million net revenue for the qtr. That is 4 million more than Q1 so I wonder if there were some further cost cuts or maybe some additional costs (hopefully not). Need to slowly increase net profit - even if it is a small amount - and continue to do so in order to garner some interest in our Amarin.
Yes, I was predicating my reply on that price level without a BO. The market is a strange beast. Just when you think it is hopeless, something fires up. Just as when you are riding high, the stock drops like a rock. So I think it is possible.
I am not much of a technical guy, but I am wondering about the $4 level. That was support for some time and they usually say that support can later become resistance so we may end up getting stuck at that level, assuming that we were to go up eventually. Of course stuck at $4 and a BO at $7 would be OK with me, especially if it happened relatively soon.
Anxious to hear from Duke. In the meantime I tried doing a little checking myself and it seems complicated. Aetna has over a dozen different plans and then some you have to choose what state you are in. At first I found a couple where, like you say, GV is non-formulary. Then I stumbled across a couple that had it as a preferred generic. Some had Vascepa as preferred brand and then some did not.
I did not check all the permutations so hopefully we get a better handle on this from Duke.
https://www.aetna.com/individuals-families/find-a-medication.html
Can they be sued for lying?
Could, interesting terminology -- Catch 22. So many BOs occur either just before or just after phase III readouts. That is when there is a lot of promise, and BPs buy into it. Now, years later, Amarin has demonstrated to BP how poor and difficult sales of V are.
BP can obviously do much better but if I am BP why should I pay Amarin for what I will bring to the table?
Split the difference. That is what it is going to take. Hopefully things clarify in the EU and a DCF can be produced that BP likes and the parties meet somewhere in the middle of proposed valuation.
Mr.Main, if you are looking for another vote of confidence, I will raise my hand --- with a couple of stipulations.
First, I totally agree that we would have to start seeing some positive earnings reports. The first couple obviously will be very small positive earnings, but as they proceed and sales from the EU start to trickle in, those EPS should grow and the market would begin to appreciate the growing earnings story. Because ultimately that is the holy grail of investing - finding earnings growth.
The thing that I am a little confused about is this Lodoco CVD approval. Apparently some reports use the term "specially formulated with no generic available" but it appears that the dosage is 0.5g whereas the generic is 0.6g and some feel that the generics will still muscle their way in. The reason for the query, is that we know that if there is no generic available then whoever is marketing the expensive brand drug would be willing to spend on advertising -- and that might take scripts away from V. If Lodoco is basically co-opted by the generic (colchicine) then no advertising means probably not much inroads for them and V scripts can stay stable (in the U.S.). Hopefully, either way, docs are concerned of the safety of Lodoco and stay away from prescribing it.
Found some commentary on this here:
Colchicine 0.5mg daily (Lodoco) approved by @US_FDA for CV risk reduction. Cost of this formulation currently unclear. Curious how/if this differs substantively from generics https://t.co/D8GYmevbNb @TCTMD @TCTMD_Caitlin
— Pradeep Natarajan (@pnatarajanmd) June 20, 2023
I wonder if this development has also contributed to the weak stock price as we know the market is forward looking.
I believe you are correct JRoon. As a matter of fact I am pretty sure Amarin themselves in some CC commented that an AG would disrupt the EU reimbursement negotiations.
As a matter of fact, PharmacyDude had a post where he indicated that the EU govts typically made these negotiations drawn out so as to kill some more clock. In essence to take up as much of exclusivity as they could so that the time before they could bring in a Generic was shortened. Part of their tactics was to delay as much as possible. I believe PD knows what he is talking about as he is in the industry.
Thanks Sleven. The following link is basically the same as yours except updated. It shows BRAVE ending in Sept. 2023 whereas the link you posted had older information showing an ending date of Sept. 2021.
https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12385
Good information in these links. Thanks for sending and spending time finding.
Has he lost a patent case?
Has he failed to join the Marjac appeal?
Has he botched the EU rollout?
Has he failed to rein in costs?
What has he failed at that the prior management excelled at?
Oh wait......maybe it was that he put his own money on the line.
Reporting on ST shows rather weak scripts. Was that for a short week?
Magnificient
6:58 AM
$AUPH Scripts of Last week
TRX: 29
NRX: 4??
Sleven, I came up empty trying to find some info about a possible patent in that field for Amarin, but I wonder if anyone knows what happened with this study and possible results?
https://www.sec.gov/Archives/edgar/data/897448/000095016208000014/ex99_1.htm
Their target has been reached. Now what?
Have to agree with Giovinco and you Kiwi, that the valuation seems ridiculous. I think to get new investors to buy into Amarin (to get the valuation up) they will need some clarity as far as revenue going forward. So UK sales would be the first thing that could affect that.
I believe they are supposed to be measuring CSF beta-amyloid, total tau, and phosphorylated tau. Although those are secondary outcome measures.
Catastrophic implosion of Oceangate confirmed. Depressing story.
16:50. - 17:30 on July 5. Oculus LT 1.05 1st floor.
https://www.heartuk.org.uk/downloads/health-professionals/conference/huk2023-programme-draft-issue-20-for-web.pdf
I certainly hope not.
It seems like registering is restricted to healthcare professionals and students. Hope you don’t think this suggestion is too flippant, but in the movies, they might try to sneak in as part of the janitorial staff?
Sleven, I should have been a little more (a lot more) precise in my post.
What I was trying to refer to in that post when using the word positive was a situation where the results of the trial would be so positive that the day after release patients would be clamoring for V and docs would be tripping over themselves writing those scripts. Hence that is why I addressed the scripts in the U.S. and the EU.
I do believe there will be positive takeaways from BRAVE, but that the key words uttered will be “further trials”.
Mr.Main, I have a similar mindset wrt BRAVE. I guess I would rather be pleasantly surprised than disappointed with unrealistic expectations (AD is a bitch). Two among a number of reasons to not expect much (at least not much that would be long lasting):
1) Positive BRAVE data might create a bit of a stir, but in the end the Generics would benefit disproportionately.
2) Positive BRAVE date I don't believe makes much of difference in the EU, where Amarin needs sales. I don't know much about the EU system (hopefully someone chimes in) but I wonder as to whether a separate reimbursement decision is required for off-label scripts there or whether docs can just go at it?
Thanks for posting. I certainly hope those at Amarin present at the UK heart symposia have read this and use it to their advantage.
PD, I believe you are correct in that this is not on the Generic company but rather the pharmacy.
My impression is that when it comes to infringing on the CVD indication of V, the culprits are more the insurance companies, pharmacies, and govts, rather than the Generic manufacturer. Yes, deep down inside the GV companies want as many scripts as possible but I don't see what they are doing currently as the major factor in the infringement. They are allowed to manufacture GV and offer it pharmacies.
PD, I actually agree with much of your characterization of the situation at hand. With a couple of thoughts:
So you say that:
Justing musing. Forget about the U.S. market for the time being. What do you think good results in BRAVE would accomplish in the EU?
Assuming we finally get some positive reimbursement in the big EU countries for CVD, would docs there be permitted to write off-label scripts? Would Vazkepa be reimbursed for off-label scripts? Would Amarin have to first go through the process of label expansion approval in the EU for AD and then wait again for reimbursement decisions in those countries for that specific indication?
Ramfan, if you ever find it, see if mine is laying around there as well.
Two ways (at least0 to look at it. On the one hand if he buys more down here, it shows some confidence but also might mean that he is just averaging and might be happy with a lowball BO. On the other hand if he doesn't buy here, it might mean he does not want to lose more but it might also mean he will want a BO for more than his $4.xx cost basis.
JRoon, no disagreement from me. It is always about the future and losing to Generics destroyed the future for Amarin in the world’s most lucrative market.
And even before that happened analysts were giving virtually nothing for the EU potential. And in the years since it has been demonstrated that the EU opportunity is/will be a tough slog.
Kiwi, all that additional information you provided is absolutely on target but superfluous and doesn't address the discrepancy in stock price. Even with that huge margin AUPH is losing much more money than Amarin. The point being (you mentioned it) that Amarin makes no profit in the U.S. and that is as a result of the DuDisaster. I was just using Occam's razor.
P.S. I will be out of AUPH long before 2025.