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One of my favorite responses in the initial brief (footnote)
"4 Unfortunately, in reprinting Table 3 of Kurabayashi’s Apo-B results, the district court’s opinion cut off the inter-group statistical comparison. (Compare Appx30 with Appx88404.) Defendants’ proposed findings of fact did so as well. (Appx102826.)"
Oh really?
Likewise, Dr.
Budoff “treated patients with Vascepa for less than 12 weeks about 5% of the time, which is consistent with [the] labelling.” (yes the defendants directly cited and managed to misspell labeling)
So as I pointed out months ago on this board, if the label is only promoting 5% usage and there is no evidence that Hikma plans to infringe then why are they advertising Vascepa's entire sales volume to investors in press releases?
lol why didn't you tell me you were going to do this before I paid the tree fiftay
I think you provide great info but this is wrong. Yes, the generics filed for ANDA and notified AMRN of it in which they filed suit. The court ruled that generics could have a use per the label that were "non-infringing" and therefore could have filed finalized the ANDA application then.
If you are saying this will not be overturned then you might as well dump the stock now.
It's not that hard, the appeal listed 3 items, one of which was the summary judgement and the only thing in that ruling that was in the generics favor was that. On another note, you have gone out of your way to incorrectly correct me several times. Do you desire to be the AMRN ihub alphadog or something? Lol
Yeah, it's good stuff. I think the overlooked aspect is that a generic could have filed an ANDA with the summary judgement declaring there is significant use for non-infringement (the less than 12 week claim). This needs to be overturned as well.
The fact that generics had this and still have yet to get a ANDA approved is telling in their confidence that they will bring this to market. They know an injunction does not go in their favor, other than having AMRN post a bond (cost of capital) that betters their position in a settlement.
There is barely any resistance holding this back. Why don't we all just sell now and agree to slam the bid at 12:05. If this is a illegal assume I was just joking
They are approved as an API for Amarin, this does not mean they are an API for anyone (although it will expedite the process based on similarity especially if NDA's from Amarin do not prevent the disclosure of some elements from BASF, like wtf is the other 4% and why does it have a 4 year shelf life).
But thanks for mentioning basf's relationship with teva. It further mitigates production getting in the hands of hikma/dr reddy as I would assume they would rather work with TEVA (who is not limited in scope of sale by patents)
Near term, other than a short term overreaction to an ANDA being approved, all I can see is green. An injunction will be granted, I beg someone to give me reason why it wouldn't. So AMRN continues as if the ruling never happened for the next year in which the EU approval would offset an unfavorable appeal outcome.
The district court made extensive factual findings, detailing
the likelihood of irreparable harm to Indivior in
the absence of an injunction while the issues are litigated.
D.N.J. Op. at *12. The district court found that “[e]ntry of
a generic would cause Indivior to lose market share and
the [S]uboxone film’s advantageous formulary status, and
would impair research and development.” Id. at *1. The
district court cited precedent that the “right to exclude
direct competition in a limited sphere, a right inherent in
the grant of a patent, is irreparably harmed by the loss of
sales and the competitive foothold that the infringer will
gain.” Id. at *12 (internal quotation marks and citation
omitted).
“Price erosion, loss of goodwill, damage to reputation,
and loss of business opportunities are all valid grounds for
finding irreparable harm.” Celsis in Vitro, Inc. v. CellzDirect,
Inc., 664 F.3d 922, 930 (Fed. Cir. 2012). The district
court found this case to fit these conditions:
It comports with common sense, and Indivior has
shown, that Indivior will likely lose market share
to DRL’s ANDA product once it is launched and
will be unlikely to recover that share, even if that
product is pulled from the market. Courts have
found that a reduction of market share due to the
loss of formulary status and a change in tier pricing,
constitutes irreparable harm.
D.N.J. Op. at *12.
The district court determined that the balance of equities
“appears to favor Indivior.” D.N.J. Op. at *1, *13.
The district court found that Dr. Reddy’s “knowingly
invested ‘at risk,’” id. at *1, and its projected “losses stem
from a market it seeks to enter, not one that it is already
in.” Id. at *13. As in Sanofi-Synthelabo v. Apotex, Inc.,
Do you want me to give you one from 2019? It shows AMRN's willingness to take on inventory (4 year shelf life helps) to gain agreements with API's. It is pretty uncommon to have as many API's as AMRN does and they did so with this intent (as well as inter-competition).
So yeah it's old but still relevant and shows the scope of the long relationships AMRN has gained.
For those complaining about management, they have literally locked up all suppliers. Suppliers that have built factories to support the need and obtained patents. With an appeal and the EU up for grabs, what supplier is going to risk losing it all to support a generic? Amarin needs to sell as much as quickly as possible and keep contracts alive even if it risks throwing away inventory.
https://www.outsourcing-pharma.com/Article/2013/08/27/Amarin-Asks-US-FDA-to-OK-Novasep-as-Vascepa-API-Supplier
I think of it like non-fish oil. Russia and Saudi can reduce the price to increase their market share but they will end up screwing themselves in terms of profit.
Why the hell does anyone want this shit Judge to add material? She messed up and she will address it while giving more information as to why the mess up was inconsequential. Do you think she is willing to admit she made the wrong decision?
Dragging out the appeal as long as possible is the best thing AMRN can do. If the generics come on the market they will have to post a bond to get an injunction filed. Even with tied up capital, the injunction should be relatively low since the expanded usage can't be claimed as damages by the generics.
Sorry to say but this will drop hard near term with the earliest catalyst being a generic approval with the FDA, which will jump back to new highs when the injunction is approved. Although something is strange here, Hikma had ANDA approval within 3 days of the courts patent ruling of zytiga https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208339Orig1s000ltr.pdf
The fact that a generic still has yet to get an FDA sign off tells me 1) the generic company was not prepared for this outcome or 2) the fda is bogged down with all the covid related priority cases or 3) discussions are happening behind the scenes
Everyone needs to keep in mind this ruling was related to the ANDA filed with the FDA. It would be clear in revenues that they are infringing AMRN's patents willfully.
The issue is Teva coming onto the market and AMRN's only profits coming from royalties, which who knows what that is?
Just as an FYI all of the arguments here were provided to the judge by AMRN in the pretrial submittal.
https://www.scribd.com/document/442173673/Amarin-v-Hikma-331-pdf
The Judge not only didn't consider many items, she plain and simply chose to make a ruling based on false claims by the defendant and her interpretation.
I mean it should have been obvious when she found the defendants definition of POSA (basically a fucking lab) as more reasonable than AMRN's medical doctor with experience in the related field.
I guess my statement was kind of vague.
When a lot of people are talking about settlements with generics, will the current settlement with Teva preclude/limit further settlements negotiations? Obviously it will but by how much? Both parties had a meeting to settle and they could not come to agreeable terms per court docs.
I have seen nothing that provides evidence that the Teva agreement was solely for the US or evidence that it did not pertain to worldwide sales. So it would just be a guess.
So real questions moving forward in the near term:
-Where are the generics at in determining bio-equivalence to Vascepa with the FDA?
-Can a settlement with generics be reached per settlement terms with Teva?
-Will AMRN give us some more info or throw us a bone with unaudited Q1 results?
-If the generic launches, will Europe honor Teva's exclusivity rights, thus voiding the 10 year exclusivity?
If someone has access to the full settlement agreement with Teva please post it. If it wasn't for this unknown, I would dump every penny I had in this.
This is not subjective
In light of the statistically-significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo B to EPA. (Id. at 737:24-738:8.).
The control group vs the epa group were not statistically significant. The statistical significance was established from the variance between measures of the EPA group having a P value of <.001. When compared against the control group (using t-method), it was deemed not significant. This is an error relating to a Judge that doesn't know math/science and simply took a document the defendant provided in their throw a bunch of shit at the wall and see what sticks methodology.
From the bench order:
The Trial focused on induced infringement (15) and whether the Asserted Patents are invalid as obvious in light of the prior art.
(15) While Plaintiffs initially asserted two indirect infringement theories, the Court granted summary judgment to Defendants on Plaintiffs’ contributory infringement theory. (ECF No. 278 at 11-13.)
This was a detrimental ruling and an appeal, despite finding the judge in error on weighing of secondary conditions, can still rule in favor of the defendants "non-infringing" uses. Thus, from the FDA's point of view, would still have to grant an ANDA with the carved out label. Depending on what the FDA requires, it may open grounds to another lawsuit.
The only reason I looked into this was because in the appeal filing they mentioned three items, one of which was the summary judgement. In the summary judgment the only item ruled in favor of the defendant was its usage of non-infringement claims. This was upheld with case precedence citing 5% was enough to establish reasonable usage without infringing. This number rapidly decreases with it's expanded usage.
This gets tricky as the court also held the fact usage can be extended past 12 weeks in the relation to non-infringement usage but didn't take the time to quantify it as the 5% was enough (AMRN expert testimony fuck up) to deem it as a reasonable usage.
Yeah, yet she took the time to elaborate on her interpretations of a POSA
and invalidated secondary conditions with reasoning that was fundamentally and scientifically incorrect.
You think if she was presented with all of this evidence, as you stated, she would write an opinion based on the most significant items in relation to the ruling. Well the shit she wrote was incorrect lol.
Ok, so looked into Kurabayashi and MC (or whoever posted) is 100% correct in the EPA group being not being statistically significant with relationship to the control group in regards to the drop in APO-B. The Judge erroneously cites the P<.001 as being a statistical significant when it is only describing the variance between the measured subjects of the EPA group.
In the study the control group and epa group were independently studied for a possible variance (this P value was calculated using a repeated measures test) and the two groups were compared against each other using a t-test. The t-test produced results that were NOT SIGNIFICANT meaning any person (skilled or not) would assume APO-B was not reduced. Just looking at the data, a -6.9% reduction is already a small value. THEN you take the -1.5% the control group decreased (6.9%-1.5% = 5.4%) and you have an even smaller number. THEN you factor in that the EPA group started with 1.1% higher APO-B level (5.4-1.1=4.3%) and you get an even smaller number.
This is huge for the case as the Judge ruled in favor of two other secondary conditions and an appellate court cannot reject the notion that this interpretation is insignificant in the outcome of the case.
Furthermore, another huge issue is the judge taking the expert opinion that 5% of the time the drug is prescribed <12 weeks as a grounds to promote the "non-infringement" citing case precedent with another ruling of 5% being deemed significant. Knowing the expanded usage being 2-3+ times that (all relating to long term usage), this number would go down to 1.6-2.5%! That means that if AMRN is bringing in 1bil/yr in revenue, then Himka can only (under the grounds/belief of not infringing) expect around 2 million. Why does their press release cite Vascepa's entire sales? Are they planning on infringing or are they misrepresenting a claim in violation with SEC regs?
I see your point but in terms of the current ruling you would have to have overwhelming evidence during an appeal, during the trial I would agree with you.
On another note, do you think Hikma is working with Teva? I mean they can do a fake launch of the limited application using Teva as the supplier and Teva can produce the generic with no limitation of the expanded usage per the settlement.
This would be some next level strategy or Teva could have just boxed in Amarin and forced them to go to court with other generics knowing that it was a possibility for the patents to ruled as obvious in a limited sense. Thus, settling would give them the upper hand. Does anyone have the full settlement agreement?
I don't think that is in-factual. If the examiner granted the patents due to secondary conditions on the basis of APO-B reductions and Kurabayashi suggested that EPA reduced Apo-B, it is a reasonable assumption to assume the examiner overlooked it.
Monday could be bad. Look up Hikma's ANDA 208339. The FDA granted approval 3 days after the ruling against J&J's Zytiga, despite a pending appeal waiting. Generics want to claim the 180 exclusivity so they all will rush file.
Kurabayashi, et al., Eicosapentaenoic Acid Effect on Hyperlipidemia in Menopausal
Japanese Women. Obstet. Gynecol. 96:521-8 (2000) (“Kurabayashi”) was published in
2000 and is prior art to the patents-in-suit.
Kurabayashi investigated the effects of administering purified EPA (96.5% EPA) at
a dose of 1.8 g/day in combination with estriol (the “EPA group”) as compared to estriol
therapy alone (the “control group”) for forty-eight weeks to hyperlipidemic, menopausal
women. (Ex. 1534 at 1.) Estriol is a form of estrogen that is commonly used in menopausal
women to alleviate the symptoms of menopause. (ECF No. 367 at 735:2-20.) As an
estrogen, estriol is known to elevate triglyceride levels. (Id.)
Despite coadministration with estriol, Kurabayashi reports a statistically significant
27% reduction in triglyceride levels in the EPA group. (Ex. 1534 at 3.) As compared to the control group, the EPA group experienced a statistically significant reduction in triglyceride
levels at the 12, 24, and 48-week checkpoints:
(Id. at 4.) Kurabayashi further reports that “[l]ow-density lipoprotein cholesterol levels in
both groups were significantly lower.” (Id. at 3.)
Kurabayashi further reports a statistically significant reduction in Apo B levels in the
EPA group of 6.9%. (Id. at 4-5.) With a p-value of < .001, EPA’s effects on Apo B were
highly significant. (Id.; see also ECF No. 367 at 737:1-23.) In contrast, Kurabayashi reports
a non-statistically significant 1.5% reduction in Apo B levels in the control group:
(Ex. 1534 at 5; see also ECF No. 367 at 737:1-23.)
The results reported in Kurabayashi do not suggest any interaction or synergy
between EPA and estriol. (ECF No. 367 at 735:21-736:9.) Instead, synergy is usually only
seen between drugs that have similar effects, such as two drugs that reduce blood
pressure. (Id.)
In light of the statistically-significant differential effects reported between the EPA
and control groups, a POSA would have attributed the reduction in Apo B to EPA. (Id. at
737:24-738:8.)
and
As explained above as to Defendants’ prima facie obviousness case, Mori found
that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo
B levels. (ECF No. 373 at 76-80, 246-47.) Further, while the Patent Office found that a
decrease in Apo B was an unexpected benefit constituting a valid secondary
consideration, the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.)
Where “the PTO did not have all material facts before it, its considered judgment may lose
significant force[.]” See i4i, 564 U.S. at 95. Thus, the Court finds that the unexpected
benefits secondary consideration does not weigh in favor of finding the Asserted Claims
nonobvious.
Also:
"Defendants filed ANDAs including Paragraph IV Certifications based on Plaintiffs’
drug Vascepa. (See, e.g., ECF No. 1 at 1-6.) ANDAs must include the proposed labelling
that will accompany the generic drug—and that labelling must generally be substantially
the same as the labelling that accompanies the brand-name drug. See AstraZeneca, 633
F.3d at 1045-46. Here, Defendants’ proposed labelling is materially indistinguishable from
Plaintiffs’ labelling. (ECF Nos. 252 at 15, 245 (sealed).) Defendants also did not seek to
omit anything from Plaintiffs’ labelling. (ECF No. 252 at 15.)"
The label has now changed with additional uses by the FDA and for the drug to be ANDA, the labels have to be substantially similar. This is another win for AMRN. The FDA may not approve an ANDA since a substantially similar label cannot be achieved without infringing on the patents.
Has anyone read the appeal filed?
"Plaintiffs in the above-named action, hereby appeal to the United States Court of Appeals for the Federal Circuit from the Judgment entered in this action on March 30, 2020 (ECF 382), and from all orders, opinions, decisions and rulings prior to the entry of Judgment, including but not limited to: (1) all findings of fact and conclusions of law set forth in the Court’s Bench Order dated March 30, 2020 (ECF 381); (2) the Summary Judgment Order dated October 28, 2019 (ECF 278); and (3) the Claim Construction Order dated August 10, 2018 (ECF 135)."
This would most likely attack the ruling in favor of the defendants summary judgement based on the drug being prescribed "5%" of the time changing with the FDA's approval of additional uses AFTER the motion was granted.
Plaintiffs’ infringement expert conceded that he treated patients with
"Vascepa for less than 12 weeks about 5% of the time, which is consistent with Vascepa’s labelling. (ECF Nos. 252 at 35, 241 at 74-75 (sealed).) Thus, there is no real dispute that Vascepa—and therefore also Defendants’ ANDA drugs—are, and can be for legitimate reasons, prescribed for fewer than 12 weeks."
Therefore, the courts interpretation of this was erroneous and was presented with the additional uses, thus reasonably could assume that this number would decrease (with the court also noting another case with a 5% ruling as substantial). Everyone has been bashing the atty's here but they knew this was the easy back door into an appeal. If they fail retrial then they will have gained another year + without generics.
If they declare an impairment charge in Q4 then Q1 will have an EPS of around .50 cents lol just a thought...
Well with a R/S you have to ask yourself if the purchase warrants would also be cut in the same proportion. If not you would have a large effect on dilution to the common shareholder.
Seems to be good for mining and growth in the DRC barring some political clash doesn't occur.
Why would anyone do that? If people cannot afford rates then housing prices would go down.
If there is a recession, people will not be able to afford homes and the prices would go down.
The only reason home values are still high for the simple fact that you point out. They want to lock in the interest rates before the fed hikes them. I think this is silly since I would rather buy a cheaper home in the first place.
People making under 45K per year can't even afford to rent homes.
Peak gold probably happened a while ago as head grades are getting lower and lower. Although, mines are becoming more efficient so it offsets. Similar thing happened with coal, I believe that there are 4 grades and we are now mining the 2nd/3rd best grades since the 1st has been completely depleted.
In the near term it seems like mines are maximizing outputs therefore increasing the supply to remain profitable but they are also not exploring since cash flow is an issue. Eventually supply will drop until exploration is deemed feasible again.
It is useless for most mines to sell gold under 1000$ per ounce so many of them will suspend operations if it does drop below that (I don't think it will).
Here is a good article
https://www.caseyresearch.com/articles/peak-gold
Exactly going commercial is simply an accounting effect. It's not like they are throwing away the gold produced they are simply using it to pay of capitalization costs but I would rather see it hit as revenue since that is what most shareholders look at. Producing 55K+ ounces per quarter isn't something you can view as a penny stock.
Ok so here is the calculation
In Q2 they produced 34325oz and sold 35655oz (1330oz from liquidation) of gold at an average price of 1194. But if you calculate the inventory liquidation it doesn't match up with the sold ounces which means because of the deals they have in place (making the realized price of gold to be 1100$ or 1150$ depending on the deal) they are losing gold.
In Q3 they produced 34824oz of gold and sold for what I believe to be at $1119 (from another company). I am assuming they keep their inventory roughly constant.
So 35655 produced and eps of .006. Because of the above they will have a fallout of about a little over 5million in rev or -.02 to -.01 EPS depending on what it is rounded to.
Yeah, I did the math. Look up the old financials and you will see BAA had 4.5koz then 2.6Kish now they have 1.6Kish.
All I did was plug in the last quarter EPS and then took into account the price drop of gold and the inventory liquidation. I could do the calculation here but I am too lazy. Mark my post and you can go back and see how right I was lol.
At least their debt will go down since all the profit from Namoya will go to capitalization costs. Should go down by about 5mil.
EPS will be -.02. They have liquidated a bunch of gold inventory and will either replenish it or keep it at the same levels.
Book is not quite 2$. The shareholders equity is 518mil - 124mil deficit which would be 1.56 per share. Then all the preferred shares and streaming transactions have extra debt when they are paid off in full. In a buyout nobody pays full price and the common share holders usually get screwed. There are also 63 million convertible preferred shares that would dilute the common shareholder.
I think it would be better for management to keep going and get enough cash to start the other mines. Although, I would be happy with anything over $0.60 per share right now lol.
I don't even have to do math. I simply go to the Q2 financials and look up shareholders equity then I go down and see this thing called "deficit" and next to it is $124,259,000.
Apparently investors paid an average of 2$ per share for them to have the shareholders capital to begin with though. Sucks to be those people lol
I'd be happy with .50 cents lol
Why would you want that when BAA currently has a negative shareholders equity? A buyout won't be good until they pay off the debt.
When you release a PR you aren't just typing something and releasing it, you are gaining a liability. There are many regulations that come with PR's and they probably see it as being not worth it.
Revenues will bring investors in, simple as that and they are getting extremely close.