Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Cheaper? Name one - PCSK9's cost 2x-3x/yr more than V and don't deliver anywhere close to the RRR V provides.
I do not believe they had 750 reps - one of the docs here (bfost?) said his rep told him AMRN was down to something like 597 reps a couple months ago and attrition was not being filled with new hires.
When an ANDA is filed when a generic certifies that the patent in question is invalid or is not infringed - that's what happened in the MARINE case in which infringement was found but moot because the patents were declared obvious and invalid. Hikma has not filed an ANDA for R-IT yet, and FDA will not accept it until 30 months past the end of Dec., so Hikma cannot challenge R-IT patents in the infringement-only case.
I don't think the case has proceeded to the point where AMRN can ask for an injunction - the case must be developed to the point where the judge can make an opinion on whether AMRN is likely to prevail or not before they can issue an injunction. Even if we get to that point sometime in the next year or so, the cash bond AMRN would have to put up in case they lose would be huge, possibly unaffordable - I think it's equivalent to the damages they're seeking. Do companies in the UK not have to post that bond to get an injunction?
Good find - not sure how it relates to induced vs. direct infringement, but it backs my claim that Hikma cannot challenge R-IT patents in the DE case as part of their defense.
Hikma cannot challenge R-IT patents before ANDA exclusivity ends this Dec, then there's a 30 month stay before FDA will accept an ANDA challenging R-IT patents. All Hikma can argue is whether they are infringing R-IT patents or not, cannot argue the patents are invalid - to do otherwise would allow them to bypass that 30 month hurdle.
Patent law obviousness and FDA approved drug indication are completely different animals - R-IT patents were granted under the assumption that they were accurate descriptions for method of use, but FDA requires proof the drug actually does what the patent claims. As far as JELIS, as long as I've known about AMRN I've wondered why JELIS didn't make R-IT obvious to try, regardless of whether anyone else wanted to spend the money to find out if and how EPA worked in treating CVD.
I know e-scripts are how things are done now, my doc has been using them for years - but what is this software you're claiming that a doc would consult prior to releasing an MI or newly stented patient from the hospital? V is still not on AHA/ACC guidelines for CVD, so wonder who the authority is that the software would query.
My browser won't let me access that website:
R-IT Regulatory Exclusivity Expiration is Dec 13, 2022 - that means FDA cannot accept an ANDA until then, and if one is filed it triggers an automatic 30 month stay. When patents expire is a totally different issue, and the earliest a R-IT patent expires is 2030, and longer than that in the EU. So I don't know what this is about, Hikma cannot challenge patents at this time - Hikma is defending charges that it's infringing on valid patents, not that the patents are invalid - that would take a separate court case that's almost 3 years away from even being allowed to be filed.
You guys are arguing over two different numbers - you are looking at the 2nd derivative - the increase in rate of weekly TRx growth for GV vs. V (33%), while davis is looking at the 1st derivative, simple weekly increase in TRx of GV vs. V (25%) - your last math step of 25/75 is taking the 2nd derivative. Regardless of what rate you want to look at, the numbers are really bad - GV is continuing to take market share, now up to 19%.
If Denmark approved where is the evidence other than that website? Google translate barfed on it, don't know what it says. No PR from AMRN, and they made a big deal when Germany sales started.
The real estate developer Evergrande defaulted on an $83M bond interest payment and they have hundreds of millions more payments due the rest of the year - they have ~$20B in USD bonds issued and have a total debt of a massive $300B - China may let them go BK, and that would lead to a global market meltdown IMO. Their bonds are now trading at 25% to par - ouch - that's as junkie as junk bonds get.
Denmark approved V? No word from AMRN about that - would be a really fast approval too. This SA author assumes Denmark doesn't approve until H1/22 (hover mouse over 2nd link to see the chart of expected country approvals):
https://seekingalpha.com/article/4456536-amarin-maximum-optimism
https://static.seekingalpha.com/uploads/2021/9/21/54701034-16322168697254336.jpg
Don't know how you found that, but I agree it's shocking that the companies weren't sued or investigated by the SEC for not releasing what's clearly material info - it doesn't get more material than a CRL! Actually, maybe some were - you'd have to find the 18% who didn't PR the CRL and google them for lawsuits - the paper doesn't give names, and the paper only looked at the time period from 2009-2013, would be tough to find such old news.
Found this article - FDA can't release contents of CRLs, only companies can, and the authors of your BMJ study worked for the FDA so they had access to them - they also say CRLs are material info and SEC requires PR for them:
https://www.agencyiq.com/the-fdas-complete-response-letter-secrecy-could-be-on-a-crash-course-with-covid/
Execs could buy a million shares on the open market and it wouldn't move this stock.
Reps have told some of the docs here that attrition had lowered reps down to 600 or so - firing 300, not 500 - savings won't be as high, but getting rid of unproductive reps is a good move. Question is with this new "target statin prescribers" move, how are they going to contact them with half the number of reps? Via email? Don't think that will work.
Only way to protect your patents is to sue the alleged infringer, end of story - unless you make a deal with them, which for drugs is usually not legal (no pay to not play) unless it's a licensing deal. I agree pulling the drug from the US for any reason, especially as some sort of tactic against generics, is absurd - that's one of the reasons I skipped hundreds of posts, was a ridiculous thread.
Post 354684 says EXAS is cutting ties with PFE because PFE's COVID policy was no in-person rep visits - I just assumed they would have the same policy in Canada, because Canada has even stricter COVID rules than the US, border is still closed to sports teams.
Companies do not leave the US to escape corp. taxes, their employees would not be willing to move to a foreign country just to keep their jobs. If you mean move more manufacturing plants overseas, if they import the products to the US they still get taxed. Stranded profits are a different issue - AAPL has a gazillion dollars stranded overseas, not willing to bring that money to the US and pay taxes on it - IIRC they run that cash hoard like a HF to make money off investments. Tax rate was lowered as a gift to rich buddies under the disguise of adding jobs, but none were created, the corps. used the savings on dividends and stock buybacks and paid off debt. Nobody is leaving the country if corp tax rates go up, they'll simply raise prices - oh, and who dropped prices when taxes went down? Nobody!
Stellar record in court? Who are you talking about? AMRN won a couple meaningless in the end cases against the FDA, but they've been crushed in the only case that mattered, by three courts. North can give his opinion on this, but AFAIK if AMRN were to cease selling in the US they would lose all patent protections and there would be no violations - if you don't defend your patents via product sales you lose them, think it's called abandonment.
The fact that PFE has policies to not allow in person sales reps visits makes their deal with HLS even stranger - w/o being able to advertise, how do they expect to increase sales w/o doc visits?
Forget the numbers, look at the big picture - what is AMRN if they partner with PFE in the EU? Basically a holding company unless they try to develop new drugs, which will be difficult even if they acquire one. I used to own a bio that sold off the sales rights for it's two approved drugs to fund a third drug and they ended up merging with someone else out of desperation, new company is a real penny stock, currently 4 cents/shr - 3rd drug didn't pan out. Before they went after that 3rd drug they just distributed cash flow to shareholders for 2 yrs - were a holding company.
Canadian sales up to 150-200K per what, quarter? If yes, that's > 50% what AMRN's doing in the US per week in a population 1/10th the size - not realistic IMO. If it's 200k/yr, that's 4k/wk, likely doable but not very profitable. Doesn't PFE have a drug or two losing patent protection in Canada? This could be a way to keep sales reps employed until they have a new PFE drug to sell.
AMRN execs have zero incentive to buy stock - they are given gobs of it for free via RSUs, and can exercise cashless options as well.
You don't understand the protection AMRN has in the EU - they will have 8+1+1 yrs of exclusivity during which no ANDA equivalents can be filed (instead of US 5 yrs for NCE), then someone has to challenge the actual patents and invalidate them - R-IT patents are strong as hell, so AMRN actually has EU protection from generics until 2035 and maybe 2039. Canada is a nothingburger compared to even China, let alone the EU - IMO PFE only signed with HLS to see if they can do one or two things - increase overall sales, and figure out how to fix the problem that the avg. patient only takes V for 6 months - if they can do both, the EU becomes much more valuable.
AMRN is only break even on US costs - we haven't seen the numbers for what their EU staff is going to cost yet, but at 200 people it won't be cheap - AMRN will have negative EPS again for maybe a year unless they can somehow revive the US market, or unless V starts selling like hotcakes in Germany.
If that's true then it means that 1/2 of the 4 g dose of V doesn't get absorbed and just gets flushed out of your body - do you really believe that? Horribly inefficient form of drug if true. What could possibly be MOA for such lousy absorption? Also, one of the most common food emulsifying agents is lecithin, and that's already an ingredient in V.
Is that $317 equivalent to US retail, which is > $400? IIRC the EU prices are supposed to include rebates/discounts to countries (no PBMs to pocket rebates, which drives up retail prices), which means that $317 is > double the WAC of V in the US (~$143) and AMRN should make twice as much money per patient in Germany as the US. If that's true, and pricing extends to the rest of the big 5, EU is going to be a big moneymaker if EU docs/patients come on board the V train quickly - hope they can resolve the problem of US patients only staying on V for ~ 6 months.
It's about more than just losing market shr in the US and the pps perhaps going down as a result - it's about all of us people on V who may have to switch to GV of unknown quality after years of great results on brand name V - eventual court victory doesn't help us avoid GV in the meantime.
Fenofibrates aren't prescribed in the EU, or do you mean insurers won't attempt to switch a patient from V to a fibrate? Per Germany pricing of $240/mo - haven't read the board much lately - has AMRN actually announced pricing but not PR'd it? Is that $240 WAC or retail, meaning are you saying AMRN is going to net $100/mo more for V in the EU than in the US? Very hard to believe that if that's what you mean, unless the cost of coupons is included in the US WAC - I'm pretty sure it's accounted for under SG&A, not in WAC, but could be wrong.
Logistics of making multiple combos of MND-2119 + lipitor make no financial sense - and insurers won't pay for a brand name combo anyway. Still have yet to see anyone explain how you get equivalent of 4 g of EPA in a 2 g cap.
Process changes? Wonder what that entails? This is saying GV will have to submit data from the new batches of API to the FDA for approval of the process change, could be a hangup. Bad news for AMRN if it's not - GV already has 17% market shr, 300 MT is enough to get over 50% - the Hikma lawsuit won't be far enough along in a year to prevent a huge surge in GV sales, insurers blocking anything but R-IT sales are our only hope in the US.
Late breakers are for research that wasn't done in time for the regular conf. submission process, has nothing to do with how important the study is or isn't.
I never expected V to have any efficacy against preventing infection, no surprise to me. Was that P-IT1's only endpoint, or did SEs include severity of symptoms? I'm thinking that's what P-IT2 is about.
Shouldn't be any problem staying on V - in any case, probably too late to matter, if you stopped today you'd still have high EPA levels come Tuesday.
Did you see North's post about the Juno/Kite lawsuit? Neither side settled there, and Juno originally won $1.2 BILLION - clearly settlement is not so easily done in some cases - and I will always believe that Hikma either didn't want to settle or asked for so much AMRN had no choice but to go to trial - JT eventually confirmed that, Hikma made outrageous demands, which is essentially saying "we're not settling" - they had nothing to lose by going to court.
Being private Affimmune is not subject to various disclosure laws imposed by the SEC - they could make almost any claim they wanted and would get away with it, no investor would be harmed.
How many people do you really think know that P-IT1 is being presented this weekend? Not a much more than the number of people that read this board is the answer, plus those that follow Dr. Bhatt's twitter feed - still a tiny number relatively speaking - the MSM sure as hell doesn't know.
Trials using hamsters don't cost much money. They are more than a few years from a CVD label, they're at least 7-8 yrs away, need to run a $500M CVOT like AMRN did - who is going to fund it knowing V already exists?