Question-and-Answer Session
Q - Michael Yee
That was great, John. Thanks for that overview. Let me maybe break the questions into a few parts, U.S., Europe and sort of other. I guess starting with U.S. before bringing Karim or you can chime into. There is uncertainty about what a generic VASCEPA could do to disrupt your current sales. We believe, yes, we recovered some of the generic companies out of India, et cetera, it's a rich company. We spoke with our analysts and we understand that they are planning to launch in due course and if not some of them later this year. Do you feel that you have a good hold on manufacturing capacity and then you have been out there, and it's not easy to source these guys? And it's tough to build that many sort of viable supply? Maybe just comment about that because it has been tough to get supply, and that might've been the issue. So maybe they launched, maybe it's limited, but what do you know and what can you say about that and what from your experience?
John Thero
So let me, there's been three generics that have ANDA has approved now for roughly a year, one has launched. Yes, there are over rich from another that they may launch. We've been at this for over a decade centrally started off with suppliers that had no capacity and work with them, made investments along the way to build their capacity and efficiency and productivity, cost effectiveness, it's been a lot of work. And as what we've generally seen is that the generic companies appear to be taking nutraceutical companies, and working with them to convert them into supplying your API for this. And there's some supply that they've been able to get by doing that. And it's not necessarily the most efficient way to do it, but it is – that requires less capital investment, thus far, we're not aware of the generic companies making large capital investments they may have, but it would be surprising to us that they did that, really not the general nature of the generic business to do so.
The best product for a generic company tends to one that they can take into their own manufacturing facilities and leverage those efficiencies as opposed to spending a lot of money building, dedicated manufacturing facilities for a single product. So we have with our suppliers, some of those dedicated manufacturing facilities. So I think typical generics, two, three months in this would have been 95% generic, we're well into it now and it's about 9% generic. I think the biggest opportunity here for COVID recede that we see this as a big market need. We think investing – remember generics don't invest in growing markets, we think investing in the growth opportunity is best for Amarin shareholders and best for society.
I would also note that the generic that's in the market and no one that's talking about potentially launching soon, have a label that is limited to, the original label for VASCEPA, which is a triglyceride lowering label for patients with a very high triglycerides associated with pancreatitis. And that was about $40 million of our business last year, ain’t to give up $40 million in business, but that's not a growing sector of our business. And what we are focusing it on is what we launched for last year, which has not been subject to and the litigation, which is cardiovascular risk reduction, where we're still how broad patent protection. And we intend to enforce our patents and grow that opportunity.
Michael Yee
We believe that one of those generic approvals with Teva, but they had actually withdrawn their approval or their plans to launch. Do you agree with that assessment that one of the generics has pulled out Teva?
John Thero
There were three ANDA has approved, one of which was Teva. If you don't act on your ANDA, it does get reclassified as being inactive whether that means that they are working in the background to develop supply or not, wouldn't necessarily be obvious by that designation. Teva is a company that by its public statements is commented that it wants did not be necessarily involved with every product, but rather be involved with products that could make money on. And this isn’t the highest margin opportunity for generic companies.
Michael Yee
Okay. Last question on U.S. before I got turn to Europe. You won't be watching the dynamics of market. However, you are still a full investment still you have the gas pedal on to drive investment in growth. At what point, can and how nimble can you be to manage expenses and be right-sized for that? I'm not talking about necessarily reducing that, but certainly maybe shifting those investments over to Europe. I wouldn't want to say that we're cutting expense for VASCEPA, shifting. Is that something that you will – you can be nimble about as you watch the U.S. market?
John Thero
I don't think we really think so much about it, about shifting. We think about it as managing based upon different stages of commercialization. So in the United States, we have a number – quite a few very good prescribers, but on surveys only about one-third of doctors know about VASCEPA than even smaller percentage of patients. It is a promotion sensitive drug, it's not surprising that these awareness levels are that low because 2.5 months into the launch, it got truncated by COVID. So as COVID comes back, we will experiment with increasing our levels of promotion to try to grow it, but with an emphasis on maintaining profitability so that there, some of – and some promotion has longer lead items, better than others.
In Europe, it's investing in a new – in a market, which take lessons from the United States, but focusing in our launch and that launch has pan-European P&L outlook, but it's really country-by-country in terms of its design. And the investment is scheduled, when do you get market access? You don't go off and put a big sales force in place. And until you have market access and different countries require different levels of staffing based upon, what can be done there from a digital perspective. Karim can give more details.
Michael Yee
So Karim given that, on the torch is being passed to you, and you're going to be also overseeing some of that. Two questions, one, how confident are you that pricing can be similar to U.S.? I can tell you that there is nervousness by the general United States biotech investment community, because European pricing is definitely can be challenging. And so that's question one, maybe start with that?
Karim Mikhail
Yes. So I mean, the confidence we have is really is sourced with that use of data, right? We're not bringing a product that doesn't have a clearly demonstrated outcome benefit. If you look within the cardiometabolic market, almost every product that came in the market over the last five to 10 years came without data had to go through pricing reimbursement negotiation, based on a promise. A promise of a positive data.
Michael Yee
I see definitely, what is PCSK9 price stat today, ballpark?
Karim Mikhail
Well, PCSK9 when they came to the market, they initially wanted the price in the €10,000 to €12,000 a year. The price went down gradually over the time. And unfortunately, very limited access to patients, even after the price went down, we believe almost by at least 50%, right.
Michael Yee
What do you think it is in Europe ballpark today net even with outcomes?
Karim Mikhail
As you know, most of the prices in Europe are confidential, right? With the exception maybe of Germany, where there is no confidential discounts, but it seems that their price level is in the range of €5,000 to €6,000 net, but unfortunately restricted to a very, very limited population. And this is where, it's very important to balance the price you're asking for, for the population, right? If you are coming in with a label that has a population of 10 million plus if not even more, you really need to make sure that you priced to have access for that population.
Michael Yee
So you're going to be right-sized about the right population versus them and you’re addressing a smaller market opportunity?
Karim Mikhail
Well, the market is bigger. The market is bigger based on the label, much bigger, right? If you look at how markets compare. However again, it's a question of the scientific evidence and making sure that you demonstrate pharmacoeconomic benefit. So in many countries is not just your population, it’s demonstrating that reducing MI, reducing strokes, reducing hospitalization with the rate of VAZKEPA, you can actually provide benefit.
Michael Yee
Do you know what the price of Esperion Therapeutics' drug is in Europe. They've launched and actually had some revenue already in Germany?
Karim Mikhail
Well, the daily price in Germany was around €3.2 if I'm not mistaken daily. So €3.2 something, however, on April 15, my understanding is that they received the non-additional benefit recognition by GBA. So how will this price evolve over time is yet to be seen. But that's the price we know and that's a product that still has ongoing outcome studies.
Michael Yee
Did they had a sort of a weak GBA rating? Is that what you're implying?
Karim Mikhail
Yes. So in GBA, you either have an additional benefit recognition or no additional benefit recognition.
Michael Yee
There are no additional, yes, there are no additional, yes there are no outcomes either, so Okay. Karim, thank you very much just because we're cut on time, but great introduction to everything, I know you guys are working hard both in U.S. and Europe. And we could talk for a long time. So thank you for the conversation. And you've got a busy day of meetings. And so I'll let you get back to that and thank you very much for being with us.
Karim Mikhail
Thank you, Michael.
John Thero
Thank you, Michael. Thanks everybody for listening. Appreciate it.
Michael Yee
Thank you, guys.
Karim Mikhail
Take care.
