I would encourage everyone to listen to the Jeffries call today. Very interesting discussion I believe.
He talked about pre Du decision that there was discussion of Amarin being worth US and ROW in the neighborhood of between 3-5 Billion with some estimates as high as 8 billion and his belief that Amarin and team can build the value of V in Europe and rest of world to 3 billion. At this price it would put us around 3 Billion X3 (conservative multiplier)/400M shares at share price of 22.5/share. He has mentioned valuations of a Billion plus from Europe and another Billion ROW but refreshing to hear him speak of value of V still possibly at 3 Billion and this is their goal to get them back to this possible valuation.
“So, remember, the launch in the U.S. was based on a value of $3 billion to $5 billion, maybe $8 billion revenue. So, if you believe that a cardiometabolic product revenue will be split 50-50 between U.S. and ex-U.S., you should also believe that you can generate revenue, ex U.S., for this product that delivered 30% relative risk reduction on top of a statin in the range of, let's say, $3 billion outside of U.S. So, that's why we are here, myself, Tom, my team; we're here because we believe we can recreate that value outside of the U.S. Now, to get there we have this three-pronged strategy by which, number one, our top priority is maximize the value of VASCEPA.”
“Today, with the cash position and the stabilization of the U.S. revenue, we feel we can continue to operate effectively without the need of finance until we breakeven in Europe. So, that's a very important message that we have today”
Germany Arbitration is complete so no more discussion on whether arbitration is still ongoing at this time or not
“So, moving forward now, Germany arbitration is complete, so we're turning that page. We're still going to fight in many other ways”
Similar tone on UK which is positive since the quarterly conference call
“We believe we are ahead of many of the analogues in terms of formulary listing, because that's what you track at the beginning.
“You cannot really depend on revenue in the early months; you depend on how many listings you really have because it says, who is voicing demand, raising their hand to say, "I need the product for my practice." And moving forward, we believe many will join that team in 2023. 2023 is going to be the launch year for VASCEPA in Europe”
Clarification on where Australia sits in the possible market share
“For example, yesterday, we announced in the press release Australia; Australia, it comes in terms of market size really after the big five in Europe”
Concerning the international markets. This could be huge when deals are signed as we would get hopefully a large upfront payment with double digit royalties which would then help the ongoing increasing roll out in Europe.
“And in all these markets we do not plan to be there ourselves. We do not plan to build infrastructure. And we are in very active negotiations, at times nationally, at times regionally, at times globally for one partner to pick up all these markets, right. So, that's really the exercise we're going through at this point in time. And honestly, the more we have countries approved the better the negotiation because it shows that the product is there, the product is available.”
AHA was a biggie for us
“And at AHA, there were two pieces of evidence presented that are very important. Number one was the PROMINENT study, which was really the last fibrate study ongoing to try to demonstrate that by reducing triglyceride you can achieve cardiovascular risk. And that study failed, which means that for those patients today who are dyslipidemic, who have cardiovascular risk with an elevated triglyceride, their only option on the market -- their only option on the market is to use VASCEPA, right.
Until 10 days ago, with AHA, people still thought they can use fibrate. Today, nobody can use fibrate anymore. We believe this is an opportunity for Europe, but even for the U.S. because you have all these patients today who are on fibrates who are going to be shifted to something. What is that something, right? And the only option is really VASCEPA.”
And yes RESPECT is hopefully going to pay huge dividends in our negotiations in Europe and Internationally.
“This is helping us in the negotiations in Europe. This is helping us address many of the challenges that we get on the scientific level from many of the leadership. And we feel confident that now, with three studies on EPA, we feel very strongly that we can really push forward for the launch in Europe and the expansion internationally.”
Thank you Japanese Heart Foundation!
Lots of concern about need to go with Authorized Generic. I voted No on the poll offered by Raf at least at this time. Please see the discussion between Yee and KM
Q - Michael Yee
Start with a couple questions, we have a few minutes. If you have a question, raise your hand. Maybe taken in two parts; one is U.S., and then second part is o-U.S. In U.S., investors fear that, hey, more generics could come in, price could still go down. How do you give people comfort even though the last three quarters have been fairly stable, that come the first quarter of 2023, either a new generic comes in or they just cut it -- price another 15%.
Karim Mikhail
Look, we've dealt with this; we have four generics already or three generics already. So, it's not like the first time a generic is going to come to the market, right. We -- if Teva is coming, now they are number four, right. And if you look overall at the trajectory, whether they were one, two, three, or four, there was the same level of erosion, which now, even with the third, has stabilized. Now, we cannot say, "Oh, we know we're going to keep this at 60% for the next 10 years," because this would be illogical, having said that, we are ready for multiple scenarios. Today, we have a very significant contribution margin from the U.S. business.
And I always say there is a big difference between breakeven, meaningful revenue, significant contribution margin. I'm saying, in the U.S., we have a significant contribution margin. And if we get a hit, we can always shift to authorized generic or any other plan that will allow us to continue to drive that same contribution margin.
Michael Yee
U.S. is currently a profitable P&L?
Karim Mikhail
Yes.
Michael Yee
And if the developments continue to go with an additional generic or further price cut, you could launch an authorized generic at some price, and then take share from there?
Karim Mikhail
Yes, exactly. And --
Tom Reilly
Yes, I mean, that yes, and we've got the scenarios as well.
Michael Yee
What would need to happen to launch an authorized generic?
Karim Mikhail
So, today, we are at a point where we have 60% of the market.
Michael Yee
Yes.
Karim Mikhail
So, if you ask anybody today, even on the generic side, is it the right moment for us to launch the authorized generic? They say, "Why would you launch that if you have 60% of the market, right?" Now, if we see ourselves losing more share, losing more position, at that point in time we get to an authorized generic. But let's face it, for us to do this, we could do it ourselves, we could do it through a third party. And in both ends, we had processes running, and we're sort of ready to go with it anyway, so.
Michael Yee
Okay. The reason I ask, of course, is because the balance sheet and the profitability is still in a pretty good position right now, certainly not after the expense reductions, but because you have a lot of U.S. cash revenues coming in providing cash every quarter.
Karim Mikhail
Exactly.
Michael Yee
So, that's to take another 20%-30% hit or whatever, it would be a concern. So, you're watching that, but it's currently profitable?
Karim Mikhail
Yes.”
IMO there may be a need to launch Generic if gets in the 45-50% market but right now we are making more with our brand at 60% market and apparently even the generics agree.
On discussion on roll out of Ezetimibe at 1/3 the price in Europe it still maxed at $1.2 Billion
“Yes, was also a different price point. So, you have to balance the patient population along with the price. What we're trying to say is, look, there are products that were reimbursed almost at a third of the price that we have achieved because of the evidence that have that got to $1 billion, right.”
Below is the only way we get bought out at a reasonable price that many of us are looking for. Some have their eyes on $20 plus. I still think 8-10/share is very possible in the next 1 to 1 ½ years.
“Look, the reality is, creating shareholder value for this company is all about now achieving pricing and reimbursement, and demonstrating success in commercializing the product, that's what this is all about.”
Excellent insight on France. I personally thought we would have reimbursement in late Summer or early Fall but I was wrong. KM never said that there was trouble with this negotiation but it was inferred by the ongoing delays until Spain became the “golden child”. Now I know that the negotiations in France are very tough. Hopefully with roll out in the other countries they will cave.
“We were asked many times, "Are you open to sell the company?" Who is not, at the right price? But you need to basically do the work, because who is going to step in today and want to go carry that negotiation in France, right? No one would want to do this.” And chuckles emphasizing how hard this has been with comments very passionate.
AI
