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The only good news from this weeks' sales figures is that Vascepa sales figures have held steady with Generics' sales figures not advancing.--------Rx for Amarin
NO MORE REPS---NO MORE ADDS---NO MORE VICE PRESIDENTS---NO MORE BOARD MEMBERS---Its all about price for now.
Cardiologists should already know about Vascepa...other health care professionals will have to wait.
When Biogen slashed the price of their drug.Aduhelm, it did not save it from the trash heap...because it DOESN'T WORK TO HELP ALZHEIMERS
Vascepa has been proven many times to reduce CVD and is being studied by the Unversity of Wisconcon(Brave study) to even help Alzheimers....so cutting price will have a beneficial effect on drug sales as well as on patients.
HDG...Thanks again for your astute, helpful analyses...
You estimate rebates to payers to be at 50% of WAC at a price of 320....This would set the price to payers at about $160/bottle...in line with the prices Amarin can eventually expect from Europe (and perhaps in the future from China)
With increased volumes resulting from lower prices, Amarin can definitely survive with this scenario until the combo drug is approved to rescue the U.S. market from the 'skinny label'.
HDG...Thanks for this analysis....
"I am not making a prediction but a scenario:"
A.) 2019 Revenue with 2022 chargebacks: 192. Cash as of Dec 31, 2022: 241
B.) “Flat” revenue: 282. Cash as of Dec 31, 2022: 331
C.) 2021 Revenue less by 20% and with 2022 chargebacks: 332. Cash as of Dec 31, 2022: 381"
B. and C. scenarios would be acceptable to Amarin...as it would get them to the point where Europe could be then poised to make some contributions in the domains of inventory management, sales revenues, and cash in 2023
Even scenario A. would be a disappointment, but not a disaster
Amarin picked the absolute worst time for a really bad quarter...The markets are falling off a cliff...In years past, I have had sickening margin calls, requiring me to sell my shares when I absolutely didn't want to...I believe that, with the whole market being down, margin calls are ...necessitating sales on considerations other than the prospective value of shares....I remember buying Ford in 2008 at about $1.00/sh.
If investors had been told of the current strategy for decreasing prices on Vascepa to increase market share... in the face of skinny label competition...it would have hurt...
But it would not have hurt nearly as badly as at it has in this time of general market collapse.
TKE458....thank you for your uplifting post...It makes me want to buy more...I'm still all in and I would buy more if I only had the dry powder to employ.
The current Amarin stock price is on track to rise unless some catastrophe occurs, such as a nuclear war.
KM became CEO in Q3, 2021 and instituted a necessary rebate system in Q4, 2021...Until then, Amarin was like a deer in the headlites....Up to that time, the most pertinent reactions from management to the Du decision were for the COB to sell all the Amarin stock in the Sofinnova fund, where he was managing director...and decline to support EPADI in their appeal....IMO because it would embarrass his friends at Covington.
KM had been appointed CEO only a short time before the EPADI appeal and had little clout to convince Ekman to back the EPADI appeal.
Since he became CEO, KM has been running Amarin again like a business rather than a sinecure.
.
In an way, Judge Du did Amarin a favor...She presided over the conversion of Vascepa to an AG....which was bound to happen anyway due to pricing pressures in ROW.
Now it is incumbent for Amarin to evolve a business model to make Vascepa work as an AG.
Amarin can put into action a simple strategy to make its great drug, Vascepa, have a great future.... CUT PRICES.....CUT OVERHEAD
Kiwi...Statins are really cheap...Many patients, including myself, will prefer a once a day med to 5 meds a day(along with the several other meds that we take daily)....The statin-MD2119 combo will not have patent infringement to contend with and the resulting huge volumes of sales will allow Amarin to charge low prices while still making significant profits.
Biopa...."Stock is a bargain at 1.40. It's basically an option, with no time limit"
I like that thought.
sleven...The gV volumes have stabilized...Health plans selling gV have now all but excluded sales of Vascepa...Vascepa sales are now powered by health plans offering Vascepa, exclusively and no gV...This means that Vascepa volumes will rise...as more health plans agree to pay for Vascepa ,exclusively...in return for the lower prices that Amarin was forced to offer them.
Amarin has essentially turned Vascepa into an AG already and I anticipate a rise in volumes after Q1 and into the future as more health plans accept the lower pricing for Vascepa and put it on exclusive or at least on equal tier as gV.
The high volume of stock transactions indicates one thing... W.S. is anticipating bankruptcy....Amarin is NOT about to go bankrupt(it has $400 million in assets)...It is incumbent on Amarin to act on reducing expenses more and, if necessary, reducing expenses even in Europe...while working to break even in the U.S.
Better still...Amarin has a great product in Vascepa that would be even greater in a BP...Sell the company NOW!
Amarin should now focus on three doable goals
1. restore patent protection in the U.S. by expediting an introduction of a statin-EPA combo drug to the U.S. market
2. increase volume by lowering U.S. prices of Vascepa and/or introducing a low price AG into the U.S....this will help satisfy Amarin's inventory commitments and produce higher sales volumes.
3. lowering expenses by cutting back still further on marketing Vascepa in the U.S.
At this time, Amarin's focus is rightfully on Europe, but it needs to break even in the U.S. to stay afloat...The low stock price negates a secondary offering.
WOW!!...What a difference between HLS Q1 and Amarin Q1 results.
This is an excellent illustration of how a rescue operation by Pfizer could be of help to Vascepa sales....and to Amarin.
PFE: FDA says no to longer course of Pfizer COVID-19 pill(Paxlovid) to address relapse
May 4, 2022
A senior official at the U.S. Food and Drug Administration (FDA) said on Wednesday that that there is no proof to indicate a longer or repeated treatment course of Pfizer (NYSE:PFE) COVID-19 pill will help patients who relapse following the completion of the therapy.....
Perhaps Vascepa's anti-inflammatory effect could be of help in 'long Covid' symptoms....Pfizer could do a study using Vascepa to treat this condition.
One...My main point still stands...Q1 was bad, but the resulting drop in price was the real disaster.
One..."they are chocking on inventory(over $400M). That problem is going to get worse as they have minimum purchase requirements and declining sales."
You're right and this fact may make them go an AG sooner than they really want to.
Q1 was disappointing, but not the disaster that the present price would imply
-45% of health plans are now exclusively selling Vascepa and volume in those plans has stabilized, albeit with lower margins...This % will go up
-Only 10% of volume for Vascepa comes from non-exclusive health plans and the volume of gV is not increasing.
-Amarin can continue to cut U.S. marketing costs and narrow its losses.
-Amarin present cash is more than enough to fund Europe until they can break even there.
-Q1 was bad...I expect that successive quarters will be better.
-Europe will eventually be profitable and the combo drug will be a success.
-Journal articles on Amarin continue to impress..as we await the Mitigate study findings..
A clear, detailed discussion of the work now being done for the development of a combo drug...and the additional work anticipated for its development would be appreciated.
Thus far, all the information that we have we have been informed of is that it will take three years...with no mention of any other details.
What are the future research, development, and regulatory issues to be dealt with for a combo drug?
J.T.'s original plan was for Amarin make a lot of money in the U.S. and to use this cash to GIA in Europe...It was a risky, but a good plan.
He failed to quickly see that the Marine patent loss at the ninth circuit demanded that it was now time to shift gears... it had become necessary for a change in plans.
He would now have to sell Amarin to a BP....and NOT proceed to GIA in Europe.
We (and J.T. also) are now paying a price for his holding on to his dream for too long.
This price is as much a reflection of the W.S. estimate of management, especially after its refusal to join the appeal for fraudulent influence in the decision in the ninth circuit decision, as it is a reflection on Amarin itself .
ILT..."Why not an authorized GV to shake out the Generic's?"
Questions for Amarin for an AG price at $180/month
1.Would generic cos. lower their prices to compete?
2.Would EU and China demand a still lower price?
3.would an increase in volumes make up for the decrease in margins?
I believe its risky, but worth a try...especially if volumes and revenues continue to decrease.
Then, when the combo drug is aproved, the US market will be ready.
Robin..."Amarin needs to launch own brand generics now"
This will happen in 2023 after negotiations with Europe and China have been substantially completed.
lizzy.."After what happened with BIIB I suspect Denner has his hands full with the BS that's going on with the Alzheimer's drug."
The failure of the Alzheimers drug may stimulate interest from a BP to buy out Amarin and to do studies on Vascepa's anti-inflammatory effects in ameliorating Alzheimers.
This would be in the interest of the shareholders, if not in the interests of management.
We need a large study, but Amarin can't spare the cash.
CBB...KM has been with Amarin long enough to speak truth to power.
-Ekman should resign.
-Amarin needs to be sold.
Research and development expenses for the first quarter ended March 31, 2022 were $10.1 million compared to $9.4 million in the prior year. This increase(i.e. of $.7 million) was primarily driven by costs incurred related to the development of a fixed-dose combination of VASCEPA with a statin.
Under U.S. GAAP, Amarin reported a net loss of $31.6 million for the first quarter ended March 31, 2022, or basic and diluted loss per share of $0.08. This net loss includes $6.1 million in non-cash stock-based compensation.
Amarin is spending much more cash on stock based compensation than on a combo drug...while the combo drug is the only thing that can save Amarin from oblivion...Amarin needs to spend $20 million/quarter on the combo development, not $.7 million!...I am disgusted!
There was no corruption in this case..There was a toxic mixture of inexperience and naievite, made worse by lawyers willing to leverage a fraudulent cropped chart on behalf of their client.
The PR heralding the positive findings in the subgroup analysis of R-IT, written up in the JACC, was a step in the right direction...It would be helpful to see PR's like this as often as possible.
Term of Office of Amarin board:
Members of our Board hold office until their successors are elected and qualified or until their earlier resignation or removal. Our articles of association stipulate that, at every annual general meeting, one-third
of the members of our Board (or, if their number is not a multiple of three, then the number nearest to but not exceeding one-third)...must retire from office, with such retiring members of the Board being eligible for re-election.
The members of our Board to retire on each such occasion will be, first, any directors who wish to retire and not offer themselves up for re-election, and second... the members who have been longest in office since their last election.
Ekman, who came on the board in 2008, has been the longest in office....I'm not sure when Ekman was last elected....Will he be standing for election this year?
"Biogen said Tuesday that it booked about $275 million in charges from Aduhelm inventory write-offs in the quarter, and it would essentially shutdown the commercial infrastructure supporting the drug."
It's time for a large study to prove the ameliorating effects of Vascepa on Alzheimers disease(especially in the early stages)...A huge market is waiting in need of an effective and moderate cost treatment.
JRoon..." I think the Du decision completely derailed us because we only have so many resources as a small company, and a lot of those resources were then focused on what to do about the generics issue."
Your view corresponds to my understanding of this shocking event...J.T. had no inkling of the coming loss.
I believe that prior to the Du decision Amarin was ready to spend cash to research additional indications for Vascepa.
J.T.'s big error was in not understanding that his strategy for Amarin had now been thwarted by the unexpected Du decision and that he needed to change course and he should start looking to sell Amarin to a BP with more assets to fulfill his plans.
It is much easier to accept and act on a positive surprise than a negative one.
It is now up to KM to do what should have been done by JT.
Rose..."Are you saying though that if Amarin were to be denied reimbursement that the decision could never be revisited or changed in the future if another Pharma took over the reins?"....
IMO reimbursement depends on the product, not the Pharma...If Nice denies reimbursement for Vaskepa sales, it would be a terrible blow for Amarin.
"I don't believe that a reimbursement decision strictly guarantees success in sales of Vazkepa. We all know Amarin's track record."
Vascepa sales were doing well until gV came along...and in Europe, there will be no gV
"As far as those other studies you mentioned, I think a number of EU decisions will come before those results are published and I am not sure that a year study in a small geographic locale in one country can be weighed as much as a multi-year multi-country study that was prescribed by the FDA to enable approval. I know that you are talking about Mitigate being used to show the slight separation at one year, but it won't be very clear cut."
I agree
Rose...A good part of Amarin's low price is WS's correct perception that Ekman is more interested in Covington than in Amarin.
If Ekman were to resign, it would be a signal to WS that Amarin's management could be once again focused on the future of the company rather than on management's friends!
Perhaps a study on a combination of Vascepa and Paxlovid could achieve statistical significance in preventing Covid infections in patients who were in contact with people already infected with Covid.
"Announcing topline data from a Phase 2/3 study for Paxlovid, Pfizer (NYSE:PFE) said on Friday that the COVID-19 antiviral did NOT meet the main goal in the trial designed to evaluate its effect in the prevention of infection''
Perhaps a study on a combination of Vascepa and Paxlovid could achieve statistical significance in preventing Covid infections in patients who were in contact with people already infected with Covid.
dogn...Whoever in Amarin management is in charge of Vascepa studies should reach out to Gilead for their opinion on the results of the Vascepa arm of the Nash study.
Dogn....Amarin holds the patent for treating CVD...It doesn't matter whether Amarin calls their EPA product ICPE or brand X...any EPA product issued by a generic company and prescribed to treat CVD is infringing on Amarin's CVD patent.
More patient event studies are needed on the effects of Vascepa on cancers, Alzheimers, arthritides, dry eyes,diabetes, hypertension, depression, obesity, etc.
Who will do these studies?.....certainly not generic companies....Amarin does not have the assets to do these studies....perhaps Big Pharma can do at least some of them.
HDG...You were proven smart to get out when you did...now I hope you'll be proven smart to get in when you did.
We have enough information to see where the ship is going...What we now need to hear from KM on May 2 are how he plans to right the ship.