Jessica Fye
Hey, good morning, everyone. My name is Jess Fye. I'm one of the senior biotech analysts at JPMorgan. We're continuing the 40th Healthcare Conference today with Amarin. I'm joined by the company's CEO, Karim Mikhail. He's going to give a presentation, and then we're going to do some Q&A afterwards. If you want to ask a question, there's a blue ‘Ask a Question’ button on your screen. Submit one to the portal. It'll come to me and I can ask those questions to management after the presentation. So with that, let me pass it over to Karim.
Karim Mikhail
Thank you, Jessica, and good morning, everyone. In today's presentation, I may make forward-looking statements. For a complete list of risk factors associated with investing in Amarin, please refer to our SEC filing.
So at Amarin, we have a bold vision to stop heart disease from being a leading cause of death. And in today's world, and I'm today on Slide #4, it is very bold as a vision because people don't realize it, but cardiovascular disease is really maybe the most enormous and worsening public health problem we have today.
And whether you're sitting in the U.S. or in Europe or anywhere internationally, the number of patients that are impacted by cardiovascular disease and the economic burden that the different countries carry today, especially at the time with COVID, where it is a significant burden, having to see all these additional cardiovascular challenges that are added to the -- because of COVID.
So it's definitely a huge challenge everywhere in the world. And up to now on Slide #5, you'll see that definitely statins and LDL lowering in general has been the gold standard for a number of years. And if you look at the usage and the engagement that physicians, patients have today with LDL lowering, is very, very strong. But having said that, LDL lowering by itself does not completely abolish the risk, you still have more than 50% of the cardiovascular risk remaining no matter how far you go with LDL lowering, that's why there is a true need to go beyond the LDL lowering and to explore other strategies to reduce cardiovascular risk for those patients in need.
And Amarin went and you, see on Slide 6, took a very challenging endeavor to engage in a multiyear cardiovascular outcome study that many large companies would shy away from committing to, simply because not only you're talking about close to $0.5 billion of investment, but also it's a number of years that you worked very, very hard, not knowing whether at the end of the day, this will succeed or not because many tried and failed, right?
So you have to go and you have to test hoping and trusting that your molecule is going to demonstrate. And Amarin succeeded in this challenging environment in developing the first and only approved medication in reducing cardiovascular risk beyond LDL lowering and received the FDA approval in the U.S. with a very unique advisory committee positive vote of -- 16 positive votes.
And when you look at the clinical evidence overall, especially for those who are very close to this field, they know that when you see a cardiovascular risk reduction above the 20%, you know that you're talking about some very significant real results that this is not just a single-digit type effect that it will be difficult to see clinically.
This is really a quarter of the risk of the events that are prevented because of the use of VASCEPA in those patients. And when you translate this to number needed to treat means how much -- how many patients do you really need to reduce an event, you could see that the number needed to treat for VASCEPA compared to other products, other classes that reduce LDL, so the initial strategy of reducing cardiovascular risk is quite positive, which means you're not only bringing effectiveness, but you're bringing efficiency to the system because you're able to save money for the payers.
And in the case of Europe, for example, for the governments who are really funding most of the budgets in the pharmaceutical market. So today, Amarin has this opportunity to establish VASCEPA as a new gold standard through gold standard in preventative care beyond the LDL lowering, and this is -- can become a true beginning of a new era for all of us.
Now that's not only sort of Amarin and Amarin science talking for itself, but there has been wide recognition by many leading medical societies of the importance of icosapent ethyl and its place in the treatment paradigms. Many of these medical societies have actually recognized VASCEPA way before the product was even registered just based on the evidence of REDUCE-IT. And that, we believe, is unique recognition. So where do we stand today in terms of our presence and launch of VASCEPA overall.
In the U.S., we have an approval. We have an approval for 2 indications, we have a VHT, very high triglyceride indication, and we have a cardiovascular risk indication that we have achieved in 2019. The business in the U.S. unaudited this year is around 575, so above 0.5 billion despite the presence of 2 generics on the market, and we've had generics in 2021, for the 12 months. So this is a full year of generic presence in the U.S. In Europe, we have an approval, which we received early in the year, 10 years of regulatory exclusivity, we just launched in Germany, very just 2, 3 months ago. And we've submitted dossiers in 10 countries, including Germany, for reimbursement.
Internationally, we have 3 partners. We have a partner in China, a partner in Canada, a partner in Middle East, Africa. We've launched in the Middle East in a number of countries. We've launched in Canada, by our partners, of course, but we still have coverage only in the private sector, not yet in the institutional sector, and we have communicated before that we are initiating regulatory process submission for multiple countries around approximately 20 countries beyond those, beyond Canada, China and the Middle East, where we're also going to be partnering on.
So for us, the whole international business is really a partner business. We believe that, that's the right way to go and you will see that even in Europe, we're only focusing on the major European markets to build our own infrastructure but in all of Central Eastern Europe, we're really going to partner most of these markets. It doesn't make business sense to be there.
Now how can we drive the growth in the future? Now I'm on Slide #12. Well, there are 3 pathways to drive the growth. The first 1 is geographic expansion. The launch in Europe is very central to all of that, and we're going to talk about it a bit more in detail in just a few minutes, but also the expansion internationally. If you look at the number of patients on statin in Europe compared to U.S., that's a similar number. If you look internationally, that's even beyond that. And we've seen a number of cardiometabolic products, that had similar businesses in the U.S. versus ex U.S. that would even others that had more ex U.S. than in the U.S. and some -- they're just focused on the U.S. So there are possibilities to drive the growth beyond the U.S., and we're going to talk more about that.
But there is also the pathway of portfolio diversification. Today, we have an established evidence with the REDUCE-IT study. It took the company 5, 6 years to have this evidence. And today, that's a big asset that you cannot just think about it and say, well, listen, let me move on to the second 1 without exploring every opportunity to maximize the business and the opportunity of helping more patients with VASCEPA and we're going to talk about 1 of those life cycle opportunities today, which we're announcing it, which that we're initiating the development of a fixed-dose combination with statins, but we're also continuing to work on business development and exploring opportunities in that space, especially commercial assets in the U.S. where we believe we have a robust structure and we can handle 1 or 2 more products without adding significant investments.
So if you look at the full year revenue, we have close to $580 million unaudited in the year 2021 compared to $614 million in 2020. So that's around a 5% decline with the introduction, obviously, of the generics full year of 2021. If you look at the quarterly results, our last quarter was a significant decline versus Q2, we had almost 8% decline. But what we've seen this quarter despite the fact that we've had a significant disruption in the U.S. business because of the restructure that we did despite Omicron, we've seen that we delivered around $140 million, which, considering the situation and how challenging the quarter was, we believe, is encouraging and we will continue to work, and I will move to talk to you more about the U.S. in just a second.
Overall, versus generics, we still maintain in the last data points, which are the last 3 months, 80% of the business. Close to $0.5 billion of cash and no debt.
Now if you look at the U.S. and the U.S. business, we have announced beginning of October that we are embarking on a significant go-to-market change and evolution of our go-to-market strategy. What we've seen is that the market is evolving and that having such a large field force today with the limited access that we have to physicians, it does not make a lot of sense to keep that structure. So we took the decision to go down from a structure of 700-something reps to 300 reps, and we implemented that in the last quarter of 2021. And we used part of these investments to reinvest in omnichannel. We can confirm that this quarter, we will be able to reach via omnichannel engagements around 150,000 physicians. That's definitely a very encouraging number that you were able already in very little time just to reach them.
Now they are not full engagements, but at least in very little time, we were able to structure ourselves in a way that we can initiate this engagement with physicians in the U.S. As a reminder, even with a very, very significant field force, our total number audience, our target list was only 70,000 physicians back then. We also announced that managed care is and will continue to be an important priority for us. As of December 2021, we have 40% of total commercial and Medicare Part D lives having VASCEPA as the exclusive IP product, and that's an area of focus, and we will continue to work on this. These are annual contracts, of course, that on an annual basis, we will have to renegotiate. So we stay very close to this priority, and we try to drive this because there is definitely a benefit for the payer in getting VASCEPA because the difference in price is not so big.
Now if we look at the last priority, the last priority has to do with fulfillment. And we spoke about it many times that we were losing many, many patients who were cardiovascular risk patients. But unfortunately, at the pharmacy level, they were switched to a generic, which is not indicated for cardiovascular risk reduction. So what we did in this last quarter was partnered with an end-to-end digital first prescription fulfillment channel BlinkRx to support the fulfillment process from a physician down to the patient level, ensuring that we can facilitate the patient can start and remain on VASCEPA, especially the cardiovascular risk patients.
Now on the next slide, Slide 15, you'll see that we're sharing encouraging early signals of the impact of the new go-to-market strategy. We're very early on. So definitely, this is just very first view of things, and we'll see if this trend continues, but we are back from a new to brand prescription to the 8,000 prescription level, which we have not achieved in the last 15 months since the first generic was introduced. We're not yet at the pre-COVID level. At the pre-COVID level, we were at 12,000. So we're still a long way from getting to a pre-COVID level. But we have not reached this 8,000 NBRx before a new to brand are really the engine of growth, right? If you don't grow a new to brand, then you cannot really sustain the engine.
So it's early signs. It's still very early on, but at least we're encouraged that it seems that what we're doing is paying off in the short term, and we'll see how this is going to evolve over time.
If you look in Europe and what we have achieved as a company in 2021, we closed the year 2020 with no regulatory approval, no work done on reimbursement, obviously, because you need a label to start to have to submit anything. There's very limited infrastructure. It was just really the beginning. We are closing the year December 2021 with an approval by the EMA and MHRA for a very broad label, I would say, especially compared to the label that we have in the U.S. We have 10 market dossiers submitted an ongoing constructive discussion with health authorities. We have established our infrastructure in Europe and a commercial hub in Zug, Switzerland. We now have a core team, especially from a medical affairs and market access perspective, really working on medical education and getting ready for the launch, we have not hired any sales force in any country, except Germany, where we launched just because we're really gauging when we invest in field force, and we plan to only do this when we are very, very close to reimbursement because it doesn't make sense to burn cash too early if we don't have a reimbursement decision.
We advanced in signing wholesaler agreements in Germany, UK, Italy and the Nordics, and now we have not just our go-to-market strategy in Europe, but our content engine, our digital capabilities and all the foundations that is needed. And our team now is around 250 associates at a European level.
Slide 17 is 2022 is going to be a year of busy intense launches where we're going to continue negotiating following up on the 10 dossiers we submitted. We believe we're going to get the large majority of the reimbursement decisions this year 2022, and we plan to launch in more than half of the countries that we submitted, but we also plan to file the next wave of 5 additional countries in Europe to complete the 15 large and midsized countries at a European level. And then all the remaining Central Eastern Europe, which are above 10 countries, we are actually now in the process of executing several agreements with established companies that have an infrastructure already there because for us, this is not an area where we would like to build any infrastructure for the future.
Now if you look at the launch we've had in Germany, and this is very, very early days. We've had a very successful launch event during COVID, where we've had 200 physicians and 200 leaders present in person right before Omicron hit. This was just -- we managed to do that. I mean we didn't know that there was going to be an additional surge obviously, in Q4, but we managed to do that in person, and we followed it by a number of speaker tours. If you look at the frequency and coverage we were able to have in Germany today because of COVID, you see that, that's still very limited. And we're showing here our average frequency on our A and B target lists where you're talking about 2 to 3 calls only up to now. And as a reminder, that's not every A and B physicians we have, we still have even out of the 12,000, that's not every B potential physician we have, we have 7,000, 8,000 more that even up to now we could not reach. So we're still working very hard on this, and we're exploring digital but other initiatives to maximize our reach to physicians in Germany. But despite that, we're encouraged that at least we're seeing our normalized uptake similar to other cardiometabolic products in Germany. It's also important to note that we received the second -- we were the finalist of the Prix Galien for the most innovative product in primary care in Germany and #1 went to the COVID vaccine. So that expected maybe.
So on Slide 19, you'll see an update on where we stand in terms of our partnerships in the world internationally. So Canada, Middle East, Africa and China. In China, we now are expecting the approval in the second half of 2022. We did receive in Q4 from the Chinese authority, a supplemental notice requesting additional technical data and information that we are now in the process of preparing with our partner adding and submitting was not really expected, but it's not uncommon, not in China and not even in EMEA to receive such requests, but they are really all focused on technical requirements not very much our scientific data that impact the usage or the indication. So this is where we stand with those 3 partnerships. But we're seeking partnerships.
Beyond that, on Slide 20, you'll see that the additional 20 countries where we're seeking now regulatory approval, which are going to come in 3 different ways. We're really solely focusing on partnerships in these markets. So we have no intention of doing this ourselves. We believe that there will be partners that can do this a lot better than us and a lot faster than us in many of these countries, and we are in the process of working on identifying the right partnerships.
Finally, on Slide 21, you'll see that we are sharing the progress we're making in terms of life cycle management and that we are initiating the development of a fixed-dose combination between VASCEPA and a statin. As you know, in cardiometabolic disease, fixed dose combinations are very, very important, simply because those patients are receiving multiple treatments. And if they have to take 5, 6, 7 different drugs that impacts your adherence impacts the motivation, impacts the engagement of the patient but also the motivation of the physician.
So we are progressing and initiating this development we believe that it is going to be a very important opportunity for our cardiovascular risk patients. As a reminder, our cardiovascular risk indication is on top of a statin. So bringing those 2 products together in 1 product we believe, is going to be more convenient for our patients and may impact overall the engagement of physicians and patients overall.
And to do that, you'll see on Slide 22, we're just summarizing where we stand in terms of strengthening our executive and leadership board in August, we've had 2 senior executives joining us, Laurent Abuaf, our President of Europe; Jason Marks, our Chief Legal Officer. We're also happy to announce that in November, Alan Wills joined us as Head of our Corporate Business Development. And beginning February, Lisa DeFrancesco will join us heading our investor relationship at Amarin. We also have Per Wold-Olsen also joining us as a new Board member as of January 2022.
So exciting opportunity to create value. A lot of it is really built on the launch in Europe, the successful launch in Europe, expanding internationally with partners, not ourselves, but also growing and defending the U.S. for as long as we can, right? If the situation changes in the U.S., and we have a stronger generic penetration more than what we do because for the moment, in the U.S., we are contribution margin positive and we are using this contribution to actually invest in Europe and elsewhere.
In Europe, so far, we have listed public prices in multiple countries, not just Germany, and they are all aligned around €200, $240. So pretty aligned up to now, and we are having the negotiations in the price and hopefully successfully in 2022. Internationally, we continue to work with our partners in creating value in those 3 territories but offering VASCEPA for partnerships in multiple other territories, and we continue to drive these opportunities to create a future for Amarin and for our shareholders.
Thank you and Jessica, back to you.
