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Amarin (AMRN) Q3 2021 Earnings Call Transcript

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AMRN earnings call for the period ending September 30, 2021.

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Amarin (AMRN 0.56%)
Q3 2021 Earnings Call
Nov 03, 2021, 7:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Welcome to Amarin Corporation's conference call to discuss its third quarter and nine months 2021 financial results and operational updates. This conference call is being recorded today, November 3, 2021. I would like to turn the conference call over to Michael Kalb, chief financial officer at Amarin.

Mike Kalb -- Chief Financial Officer

Good morning, everyone, and thank you for joining us. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include but are not limited to -- these statements are based on information available to us today, November 3, 2021. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements.

Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into such as mergers, acquisitions, dispositions, joint ventures or any material agreements that we may enter into, amend or terminate. For additional information concerning the factors that could cause the actual results to differ materially, please see the Risk Factors section of our quarterly report on Form 10-Q for the quarter ended September 30, 2021 and our annual report on Form 10-K for the year ended December 31, 2020, which have been filed with the SEC and are available through the investor relations section of our website at www.amarincorp.com.

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We encourage everyone to read these documents. This call is intended for investors in Amarin and is not intended to promote the use of VASCEPA. An archive of this call will be posted on Amarin's website in the investor relations section. Karim Mikhail, Amarin's president and chief executive officer, will lead our discussion.

And I will provide a more detailed review of our financial results. After prepared remarks, we will open the call to your questions. I remind you that multiple audience typically listen to calls of this nature, including existing investors, potential new investors, employees, current and potential collaborators, and current and potential competitors. As always, in this call we will attempt to provide constructive information without compromising our competitive and strategic positioning.

I now turn the call over to Karim Mikhail for a review of the business.

Karim Mikhail -- Senior Vice President and Head of Commercial

Good morning, and thank you all for joining us this morning. The third quarter of 2021 was a critical quarter for Amarin, as we continue to make important strides toward our goal to bring VASCEPA/VAZKEPA and its CV risk reduction benefits to at-risk patients around the world. These advances were led by the meaningful progress we made commercializing VAZKEPA in Europe as highlighted by our successful product launch in Germany in mid-September. This was followed by the announcement of our transformative go-to-market strategy in the U.S., which underscores our commitment to the U.S.

market. And it's designed to enhance awareness and drive demand for branded VASCEPA in the cardiovascular risk reduction indication. Last quarter, when I had just taken over the CEO position, I shared with you the vision for our three-dimensional growth strategy: breadth, geographic expansion; height, representing diversification; and depth or operational evolution. Today, I'm happy to report on the progress we've made executing the strategy, including a number of milestone achievements demonstrating that we are well on our way to become the global cardiometabolic commercial player we envision.

Let me begin with a brief review of our results for the third quarter. Starting with our revenue. As you saw in our press release this morning, we reported net total revenue for the third quarter of 2021 of $142 million, compared with $156.5 million in the same period in 2020. We reported net total revenue year to date of $438.7 million, compared with $446.8 million for the first nine months of 2020.

The bulk of this revenue is from U.S. product sales of VASCEPA. Importantly, and as Mike will discuss later in the call, our U.S. VASCEPA franchise remains profitable, and along with our strong balance sheet, continues to support our growth and expansion plans.

Now for a deeper dive into the U.S. market. This has been a particularly challenging quarter, as a number of market and competitive dynamics impeded the potential for growth in the U.S. First, the impact of the research and COVID-19 Delta variant caused patient visits and lab visits to drop by 6% and 7%, respectively, compared with the prior quarter.

Additionally, the lipid market flattened for the first eight weeks of the quarter. Finally and for the first time, there were two generics available on the market for an entire quarter. These dynamics created both the need and the opportunity to reevaluate our strategy, so let me walk you through our thinking. We needed to better understand the key gating factors to building more significant adoption of VASCEPA for its cardiovascular risk reduction indication and to develop a plan to tackle them.

Perhaps the biggest driver for growth is improving physician access and engagement. Long before the COVID-19 pandemic hit, access to physicians was on the decline. For example, according to ZS' Access Monitor, access to physicians in 2007 was approximately 80% or four out of five. By the end of 2019, that access had fallen to about 50%.

During the early days of the quarantine in 2020, those levels were at near 7%, and they currently stand at only 29%. In other words, less than one out of three physicians on average is accessible for visits by the field force. Our new strategy employs a digital omnichannel approach to enhancing our reach to healthcare professionals, allowing us to target a far greater number of the almost 700,000 statin prescribers through high-frequency, customized and impactful messaging regarding the significant benefits of VASCEPA for CV risk reduction. Simply, this creates a model of engagement with prescribers in the ways they want.

We intend to significantly increase the use of these robust digital platforms and integrate them with in-person visits by our sales force to enhance our reach and customer engagement and improve efficiencies optimizing our educational and promotional efforts to drive healthcare provider and patient's use of branded VASCEPA in the U.S. These digital platforms include a variety of offerings such as virtual detailing, email campaigns, websites and medical portals, digital CMEs, social media, and more. Our next area of focus is managed care. While several large commercial and Medicare Part D payers currently cover VASCEPA as the exclusive icosapent ethyl product, we are intensifying efforts to remove remaining barriers to VASCEPA prescription to improve access to patients with real medical need.

We are confident in our ability to drive further volume growth by continuing to focus on enhancing payer access. Finally, our last, equally important area of focus is to clarify the difference in approved indications between VASCEPA and the generics. Generics are not FDA approved for cardiovascular risk reduction. We are taking a variety of steps to eliminate confusion created by the limited indication of the generics and educate the market regarding the substitution of VASCEPA with generics for non-indicated uses, particularly at the pharmacy level.

Our goal is to continue to correct factual inaccuracies within the total prescribing ecosystem from the references compendia to retail pharmacy systems, to e-prescribing platforms used by physicians in order to reduce substitution for non-indicated uses and minimize any disruption in patient care. Correcting these systems is a complex process. And it will take some time, but we are making progress. And we expect that we can make a significant difference in keeping generics usage within their narrow approved label for all the above.

At the end of September, we announced what we believe will be our transformative go-to-market strategy, which underscores our commitment to the U.S. market and addresses three key areas for improvement: expanding physician engagement and access, enhancing managed care access and optimizing VASCEPA prescription for CV risk reduction. Our goal is to deliver a simple streamlined platform to manage end-to-end flow of prescription and to ensure an optimized patient and prescriber user experience. While these new go-to-market initiatives are in the early days, we will be driving their implementation with a focused sense of purpose while tracking and reevaluating our decisions.

We have three measurements for success. Execution. Did we successfully and urgently implement these initiatives? Strategic impact. Did they deliver their expected impact? Revenue.

And ultimately, did these initiatives produce greater patient and provider usage, resulting in prescription and revenue increases? We are confident that this new go-to-market strategy will be successful by all measurements and look forward to reporting more on this front as it unfolds. We also continue to consider and entertain numerous strategic initiatives which, if feasible and successful, could allow us to further differentiate versus the generics. While in early stages, we believe that such efforts aimed at truly differentiating ourselves versus generics would have a significant impact on the future potential of VASCEPA in the U.S. Turning now to our progress in Europe.

During the third quarter, Amarin demonstrated its commitment to becoming a global commercial player with its launch of VAZKEPA in Germany. As a reminder, when Amarin announced in August 2020 that it would self-launch in Europe, we had no legal entities in Europe beyond Ireland, no infrastructure and no commercial presence. We did not even have a regulatory approval for VAZKEPA. Today, just a little over one year since that announcement, we have an EMA-approved label that is totally consistent with the broad patient population of REDUCE-IT.

We have 15 legal entities and branches, including a commercial hub in Zug, Switzerland; 300 employees; and have executed our initial commercial launch in Germany. We are especially pleased that our teams were able to launch in Germany on such an expedited schedule. The launch debuted with a successful scientific conference that was led by 11 internationally renowned cardiovascular specialists and was attended in person by more than 200 healthcare professionals from Germany, with a live stream to many more physicians across the continent. The medical and commercial teams have made great strides introducing the cardioprotective benefits of VAZKEPA to the German market with 60 events hosted to date and more than 50 events approved and ready to execute before year end.

This is a very proactive plan. And our team is making every effort to reach our target audience both physically and virtually, as access to physicians and hospitals in Germany is still limited due to COVID. In these early days and for the next couple of quarters, we believe the best proxy for a successful launch will be illustrated by the scientific endorsement from the key thought leaders and top societies, and our ability to engage, educate, and promote VAZKEPA to our targeted audience. We are pleased to report that VAZKEPA has been included in Germany's electronic prescribing system, which is updated quarterly effective October 1.

This is an important step in making VASCEPA more readily accessible, as paper prescriptions represent a very small portion of total prescriptions today. We were honored to be one of three finalists for the Galenus Von Pergamon Prize or Prix Galien in Germany, a prestigious scientific prize awarded for a particularly innovative medicinal product that has been approved in Germany at the time of submission. This year's prize went to BioNTech, Pfizer, for their COVID-19 vaccine, so we are truly honored to have achieved the second place and we have been widely recognized for this achievement in the German press. Now on a European regional level.

We previously communicated that our goal is to file 10 market access dossiers by year end, and I'm proud to report that we have already submitted all 10. This really allows Amarin to initiate the negotiation process with the reimbursement agencies of the largest 10 markets in Europe. Those markets are Germany, U.K., Italy, France, Spain, Denmark, Sweden, Finland, Norway, and the Netherlands. We have already engaged extensively with several of these countries, and in our next earnings calls, we will provide an update on our exchanges and expected time lines for reimbursement approvals.

I can also confirm that all 10 submissions included data demonstrating the uniqueness of VAZKEPA from a scientific perspective, various country-specific demographic data to define the eligible patient population based on the label and the same targeted list pricing of approximately EUR 200 or $240 monthly. The next wave of country submissions is being initiated now and will include five additional countries in Europe. We have also initiated the first steps to identify the partner or partners we plan to collaborate with in the Central Eastern Europe countries, starting with Greece. Over the past year, we have been prudent yet agile, fast, and at the same time measured in how we have built investments in infrastructure in Europe.

We are prioritizing and structuring our markets organization in a focused way, driven by our belief that a tremendous opportunity exists to change the treatment paradigm in preventative cardiovascular care across Europe. Beyond Germany, in the vast majority of our targeted markets, we are in the important three-launch phase, which means that we are establishing relationships with healthcare professionals providing education on the cardioprotective benefits of VAZKEPA and negotiating market access. Our digital-first strategy and the capabilities we've developed implementing it allow us to quickly navigate and access our customers differently while complementing all of our field force efforts. We recognize that not all markets are the same, and our approach to each must be tailored and bespoke.

The technology behind our customer engagement ecosystem allows us to have an aligned commercial model that can be easily adapted to the specificities of the individual market and enables us to successfully integrate our digital and face-to-face channels in one single cross-functional plan. We are very excited about the opportunity for VAZKEPA in Europe, as CVD is an increasingly common health problem that causes 3.9 million deaths per year in Europe and costs the European Union EUR 210 billion every year. Our mission to rethink the treatment of residual cardiovascular risk across Europe is no small feat, but we're up for the challenge. We are committed to improving the lives of high-risk cardiovascular patients across Europe by establishing a new treatment for CVD.

Setting a new standard in cardioprotective care won't happen overnight. However, we have a high level of confidence that we've got the drive, the scientific evidence, the strategy, and the people to make it happen. Beyond the significant multibillion-dollar market potential in Europe, let me turn to the other international opportunities we are pursuing. Last quarter, we announced our ambition to bring the cardioprotective benefits of VASCEPA/VAZKEPA to the top 50 cardiometabolic markets worldwide.

We currently have access to approximately 30 of these markets and have now mapped our strategy to obtain access in the other 20. Our plan will take place in three ways. The first will begin in 2022, when we plan to submit regulatory filings and obtain product approval in up to six countries, including Australia, New Zealand, and Israel. The second wave will come in 2023, when we will seek approvals in up to nine countries.

The third wave follows in 2024, when we will be seeking approvals in the remaining five countries we have targeted. These filings will all be supported by long-term cardiovascular outcome data from the REDUCE-IT study and the FDA and EMA approvals of VASCEPA/VAZKEPA for the cardiovascular risk reduction indication. We will be specifically seeking our EMA broad label language in all of these countries. In most of these markets, we will potentially opt for an agency distributorship partnership.

Such collaborations have the advantage of giving us control over the marketing authorization of our product and providing optionality as we grow the business globally. We believe expanding Amarin reach to these additional 20 markets has the potential to benefit millions of patients at risk of a CV event and represents a market opportunity of around $1 billion. Moving on to other international markets where we already have partners. In China, our partner, Edding, continues to expect to receive approval of VASCEPA in Mainland China and Hong Kong near the end of 2021.

With these approvals, Edding has plans to launch in these territories in 2022. As in the U.S. and Europe, VASCEPA will launch with the support of the two key Chinese cardiology societies. With the burden of CV disease in China and with two branded statins collectively selling more than $1 billion, there is both a significant medical need and a meaningful market opportunity for VASCEPA in China.

In August 2021, our partner in Canada, HLS Therapeutics, announced a promotional agreement with Pfizer expanding promotion of VASCEPA to primary care physicians in Canada. HLS' existing sales force of approximately 30 field personnel and support staff will remain primarily focused on the specialist physician audience. We believe this new agreement should bode well for VASCEPA in Canada, as the primary care physician market is a good gateway to patients at risk for CVD and the Pfizer name is well respected and known for excellence in the pharmaceutical industry. Finally, let me share some perspective on our thoughts around diversification, the height dimension.

We continue our systematic review of all potential assets in the cardiometabolic and obesity space. We are not limiting ourselves to those that lend themselves to primary care and large populations alone. We're also considering unique assets, including in the specialty and rare disease spaces, where there remains tremendous unmet need. We are prioritizing two types of assets, assets with near-term commercial potential and development stage assets that have the potential of significantly enhancing and transforming our portfolio.

As you can appreciate and due to our primary focus on the cardiometabolic space, this process requires time; and scientific, commercial, and financial diligence. We are dedicating the needed resources and continue to believe that this is an important leverage for future growth. With this overview of our business, let me turn the call over to Mike Kalb, our CFO, for a more detailed discussion of our financials. Mike?

Mike Kalb -- Chief Financial Officer

Thanks, Karim. During the third quarter of 2021, we reported net total revenue of $142 million, a decrease of 9% compared to the third quarter of 2020, and $438.7 million for the nine months of 2021, a decrease of 2% over the same period of 2020. During the third quarter of 2021, we reported net product revenue of $141.4 million, a decrease of 9% compared to the third quarter of 2020, which was largely driven by decreased U.S. VASCEPA sales as a result of the impact of generic products for VASCEPA's initial indication and the ongoing impact of the COVID-19 pandemic.

For the first nine months of 2021, we achieved $436.6 million, a decrease of 1% over the same period in 2020, which was largely driven by a decrease in sales to our partner in Canada of $8.5 million, which included an initial order in 2020 for the launch of VASCEPA in Canada, partially offset by an increase in U.S. VASCEPA sales of approximately $2.9 million. However, as Karim noted, despite this decrease, the U.S. business has continued to be profitable in the third quarter as a result of our continued expense management.

Despite the generic competition in the U.S., we believe that the patient need for VASCEPA in the U.S. is high and that our new U.S. go-to-market strategy will accelerate revenue growth in this market. The profitability of our U.S.

operations continue to support the expansion into Europe and other geographies around the world. However, due to the variability of spend related to these initiatives, our overall profitability in the short term may fluctuate. Additionally, absent the one-time charge of $14.1 million related to the transformation of our go-to-market strategy for the U.S., we would have achieved net income in both the three and nine months ended September 30, 2021, which further shows that we have positioned ourselves for growth both in the U.S. and throughout Europe.

Additionally, we continue to monitor the ongoing global supply chain issues which are resulting in inventory supply shortages for numerous companies and products. While we are not currently impacted by these shortages, we continue to focus on maintaining adequate supply to meet the expected global demand. As of September 30, 2021, Amarin reported aggregate cash and investments of $517.9 million, consisting of cash and cash equivalents of $222.9 million and liquid short-term and long-term investments of $256.3 million and $38.8 million, respectively. We believe our current resources and the U.S.

profitability are sufficient to continue to support launching VAZKEPA successfully throughout Europe and in other international countries throughout the world. With that financial overview, I will now turn the call back to Karim for closing remarks. Karim?

Karim Mikhail -- Senior Vice President and Head of Commercial

Thanks, Mike, for the financial overview. Now that we have shared our road map for the future, our goal is to keep our eyes on the road ahead as we execute our strategy to reinvigorate growth in the U.S., successfully launch VAZKEPA in multiple countries in Europe and obtain regulatory approvals in a number of new countries in 2022. We believe the realization of these ambitions for Amarin will be our collective success, as I'm confident that achieving these goals will build value for the company and enhance shareholder value over time. With that, operator, we're ready to open the call for questions.

Questions & Answers:


Operator

Thank you. [Operator instructions] And the first question is coming from Yasmeen Rahimi from Piper Sandler. Your line is live. 

Yasmeen Rahimi -- Piper Sandler -- Analyst

Good morning, team. Thank you so much for sharing all the updates and congratulations on filing the 10 dossiers ahead of schedule. Karim, I would love to understand a little bit more the cadence of these 10 dossiers and how soon they would be put into place and how should -- we should be thinking about it. So is it -- could we be expecting that over the next six months, all of those dossiers would potentially be granted and you could start building a market strategy in these countries? So just give us an idea of the cadence of the 10 dossiers that are in place.

That will be very helpful. And then second question is, as you are now in launch in Germany, do you still continue to be confident that you would like to launch on your own? Or is there change of hearts of potentially considering partnership? Thank you for taking my questions. 

Karim Mikhail -- Senior Vice President and Head of Commercial

Thank you, Yasmeen. So on the 10 dossiers, it is great that we were able, speaking of cadence, to already submit the 10, right? The amount of work that is required in specific analyses that those agencies require, it's huge. Maybe people don't imagine the magnitude, but some of these files are one gigabyte and they include up to 300 analyses of our patient population in REDUCE-IT. So already the fact that we have submitted, we believe, is a great milestone.

Now with regards to the next steps, I'm going to generalize because these are 10 countries and all of them have a very different time line and a very different process and even attitude toward dealing with the files. You have a group of them that actually have a clock, meaning they're tied to coming back to us at a certain point in time with a preliminary reaction. Example of these countries are the Nordics. Usually most of them have a clock and they have to come back to us usually in 90 to 180 days with a response.

Some of these preliminary responses are going to be a no because that's part of their strategy. And then we immediately answer their questions and we move to step two. So this is with regards to those that have a clock. A number of countries don't have a clock.

Italy doesn't have a clock, right? France doesn't really have a clock. It can take longer, shorter time, but we are in direct engagement on a weekly basis with these agencies. We did receive from all of them all their questions. And in many, we have already responded.

That's why you saw that in our earnings script just a few minutes ago we said that by next earnings call, we will be able to provide detailed feedback and a time line because, by next earnings call, we would have received a reaction to where is this going, how long it's going to take us. But we are talking about approvals of those 10 dossiers in 2022. Some might come early. Some might come later, and it will all depend on the negotiation.

I will remind everybody that if we go and concede on the price and say, "Oh, we're willing to discount x percent," we may have a faster reimbursement, but I'm not sure that this is going to build shareholder value on the long term. So that needs to be taken into account. So that's on the 10 dossiers' cadence and what we expect over the next few months. Now in terms of launch in Germany, we have already planned and invested for a self-launch in Germany.

If you compare the investments we put, the size of the field force, the infrastructure we built, I think it's as robust and as big as many of the key players in the biopharma. Now do we answer phone calls and do we talk to partners when they give us? On ongoing basis, right? And we will always challenge ourselves whether we're doing the right thing, yes or no. There's no dogma around this. This is business.

We're launching. At this point in time in Germany, it's still pretty restricted because of COVID. We have not reached out to everybody in our target audience until today despite the fact that we've been on the market for a few months. So it will take us or anybody else some time to engage in the German market.

That's why we're saying that the best proxy we can look at, at this point in time is really the support and the endorsement that we're getting from the societies, from the scientific leaders. And we believe that the ramp-up will happen slowly but surely.

Yasmeen Rahimi -- Piper Sandler -- Analyst

Thank you.

Operator

Thank you. The next question is coming from Roanna Ruiz from SVB Leerink. Your line is live. 

Roanna Ruiz -- SVB Leerink -- Analyst

Great. Thanks. Morning, everyone. A quick question on Germany.

I was curious if you could elaborate on the number of physician targets you're possibly focusing on. And what types of practitioners appear to be early prescribers of VAZKEPA? I'm specifically wondering if they're more high-volume prescribers of statins. Are they more specialists or generalists, etc.? Whatever color you can provide. Thank you. 

Karim Mikhail -- Senior Vice President and Head of Commercial

Thank you, Roanna. So to give more granularity on the German launch: so we did target every specialist that really is involved in the cardiometabolic and cardiovascular risk management. So basically, between hospital and private cardiologists, we really cover basically 100%. In terms of GP practices, we cover the percentage that allow us to cover 80% of the business, which are in the tens of thousands at this point in time, so it's a pretty significant target audience.

That's why with the restriction, we actually had to prioritize, because the way we segmented and targeted, we used volume, so the potential of these physicians as a key criteria, as the target, but more importantly, who are in the innovation business, who are the ones who very readily prescribe new products that are not the EUR 1 to EUR 2 style, and they're willing to innovate and go beyond what is traditional to support their patients. So this is the lens that we use. Definitely because of the restriction, we have to focus on our target, A and B, not the C and not the D, just because, for us to deliver prescriptions, you have to visit the physician at least three, four, five times, right? That's the bare minimum that you need to deliver to truly engage, to truly have a dialogue. And until the product goes on to market, we hardly were able to get to the three maybe or some, maybe four.

So as you saw that we communicated the number of meeting events that we're having because that's another strategy to reach out to physicians. It's one-on-one, a speaker tour. So after our launch event, by the way, we had a very significant effort to do a German speaker tour with a number of speakers who went from region to another because that can get those physicians who are not open to go to a physical meeting. Instead of driving, traveling and being with, for example, 200 other physicians, if they see that the group is 20, 25, 30, they are more comfortable to attend.

And this is what we've done, when you saw that we said 60 meetings up to now, these are the sort of events that we execute. Going back to your question about how many are early adopters. The early adopter range is in the single digit of the German target audience, OK? So just also to see it in a quantitative way, but again, a lot of effort, important strides. And we believe that, over the next couple of quarters, we will be able to see better the picture of the uptake in terms of scripts and revenue.

Thank you, Roanna.

Roanna Ruiz -- SVB Leerink -- Analyst

OK. Great. That's really helpful. And then maybe a quick switching gears to the U.S.

I was curious. What metrics are you internally tracking to understand how the new U.S. go-to-market strategy is gaining traction? And how might that inform your push and pulls on how you adapt your strategy in the next quarters? 

Karim Mikhail -- Senior Vice President and Head of Commercial

Sure. Great questions. So the metrics we're focusing on really are the ones that relate to what we know is critical at this stage. As you've heard, we said that we know that it is incredibly difficult to drive growth if you don't have the breadth and the depth of the engagement with the target audience.

We did have a large field force, but despite that and because of the access limitations at the physician level, we were not able to engage with them because the door was not open. So what we did was to redefine a number of territories where our reps and our sales managers can actually engage, meaning they're not going to spend their day knocking on doors that are closed, right? So a very important metric is the level of engagement that we're able to deliver. Our team is able to meet, discuss and move the needle. So the breadth of the reach but also the depth, meaning how many prescriptions on average we are able to drive.

Up to now, 50% of VASCEPA prescription are driven by only 6,000 prescribers in the U.S. That's why we believe that there is an opportunity that we expand and broaden the engagement and even have deeper engagements that we can drive this number to be higher and the number of scripts delivered by physicians. So that's one metric relating to engagement. The second one has to do obviously with the situation with the generics because today what we are seeing is that a significant number of patients who are indicated for cardiovascular risk indication, which is an indication not approved for the generic, are still getting the generic.

And there are things that we can do as Amarin about this and there are things that are out of our control, let's face it. If the generics continue to supply the market beyond what is needed -- I'm being very clear. Beyond what is needed because the indication size that they have is literally 7% to 8% of the market, but if they continue to push more supply, the payers will use it and we have challenges. That's not in our control.

There is a legal sort of path to deal with this. What is in our control is what are we doing to secure the fulfillment of our own prescription. So what we're really focusing on as a metric is what is the fulfillment rate. How many rejections are we getting? Are we truly getting, at the end of the day, every prescription that is written by a physician, fulfilled at the pharmacist at the end of the day? And that's why we have a number of initiatives to drive this level of fulfillment to be much higher.

So these are really the metrics we're focusing on. I -- it's a difficult question, Roanna, but I hope I clarify. 

Roanna Ruiz -- SVB Leerink -- Analyst

Yes. That was helpful. Thanks. 

Operator

Thank you. The next question is coming from Michael Yee from Jefferies. Your line is live. 

Michael Yee -- Jefferies -- Analyst

Hi. Good morning. Thanks for the questions. Two questions, if I may, really quick.

One is if you go back, you had mentioned -- or prior management had mentioned there were some lawsuits initiated against pharmacies, in part trying to enforce on-label prescription dispension. Can you just remind me briefly where those were, whether there is any update on the proceedings of that? I think that would be an important potential development in the future, so just remind me on that, if there's any traction there. And then second question is I thought your slide around business development was really interesting. And you gave some pretty good specifics: cardiometabolic obesity, specialty rare diseases.

And I think I'm aware of some of those products out there. Can you just comment on how urgent or how near term these types of things could be? I think that could be quite interesting to leverage your sales force, so maybe just talk about that because I think that could be important. Thank you.

Karim Mikhail -- Senior Vice President and Head of Commercial

Perfect. Thank you, Mike. So on the lawsuits, let's clarify. We actually do not have any process against any pharmacy or pharmacy chain.

We actually have one against a generic supplier and a payer, specifically, [Inaudible]. That's what we have in place. This is what we continue to pursue. There was at a certain point in time a request from the two of them to basically dismiss the case.

There was a magistrate opinion to deny this request for dismissal, then the district judge asked for an actual hearing. This took place two weeks ago or a bit more, and we're expecting a decision by the judge on accepting or rejecting the request for dismissal in the next few weeks. In any case, if it's accepted, we will appeal and we will continue to fight this. And if it's denied, we also continue with that because we believe that we have a very strong position in terms of our real standing on this issue.

So that's on the first question. Is that OK?

Michael Yee -- Jefferies -- Analyst

Yes. Very helpful on that part. Great.

Karim Mikhail -- Senior Vice President and Head of Commercial

Yeah. On the second question, with regards to diversification. We wanted to add more color in this earnings call to almost qualify the type of effort that we are making and what we're targeting. This was not intended in any way to somehow highlight time lines or even urgency because we get the question very regularly.

What are you looking at? What are you focused on? And we wanted it to be clear that we believe we're building an incredible equity in the cardiometabolic obesity space. These are the leaders, the thought leaders, the scientific authorities and we're engaged with them today. We're building credibility. We're building equity, so we have no intent to spread ourselves thin and go under some therapy areas that will take us away from all of that while we're launching VASCEPA and VAZKEPA.

I'm saying launching VASCEPA because I think we're still on launch mode in the U.S., right? So that's the focus on cardiometabolic, anyway. Now if we say we're so clear about this focus area, we cannot say, "oh, but then let's only focus on primary care style, large-population assets," because that limits our sphere of assets dramatically. And we believe that, whether it is in primary care, specialty or rare diseases, thought leadership, scientific associations are more or less the same. It will allow us to evolve our go-to-market model, by the way, but we're very open because we're very nimble and we can adapt to different asset types because we believe we have the talent and the experience in the space.

So that's with regards to [Inaudible]. I hope this was sufficient, Mike. 

Michael Yee -- Jefferies -- Analyst

Thank you. 

Operator

Thank you. The next question is coming from Louise Chen from Cantor. Your line is live. 

Louise Chen -- Cantor Fitzgerald -- Analyst

Hi. Thank you for taking my questions here. So first question I had for you is, you do talk about sort of a stabilization in U.S. sales here.

Maybe just a little bit more color on what gives you confidence. I know that you talked about how you plan to get there. And then the timing, if there's anything that you could give us, elaborate a little bit more on when you think you might see that. And then how should we think about the operating expenses in fourth quarter '21? I know you talked about a little bit of lumpiness.

So maybe if you could help us there or just give us some broad strokes, that would be great. And then just last thing here is as you look at the global opportunity. Outside of that $1 billion, you also have China and Hong Kong and other areas of the world, so when you look at the global opportunity, where do you think peak sales could get to?

Karim Mikhail -- Senior Vice President and Head of Commercial

Great. Thank you, Louise. So first, on the U.S. sales.

I mean our announcement that came out like a month or so ago about the change in the go-to-market strategy, it's to respond to the challenges that we've seen. So we're very conscious that at this point in time, with our execution but also with the dynamics that are taking place, we are not delivering the growth that we want. And that's why we made changes. Now with change comes a bit of disruption, right, temporarily.

Let's be very real. I mean our -- the 300 people that we have on the field today are incredibly qualified. We believe strongly that they are the right group to lead this next phase of the growth. Having said that, for many of them, they're going to have 50% change in their target audience, right? They're going to be now in this first month meeting people that they have not met before, that they need to establish working relationship, that they need to understand where are those physicians on the prescribing continuum.

Are they believers? Are they nonbelievers? What do they need to do? So there will be a period where we're making this foundational effort to say, OK, this is a new page. This is a new era. This is a new team. Let's go and see how far we can go.

So it will take us a couple of quarters to basically anchor ourselves and get this new go-to-market strategy to operate, but at the same time, we are starting very aggressively all the digital omnichannel as early as from weeks simply because that was one part of the strategy that we could press on the button and immediately engage with a far broader group. So this is to say we're making every effort to advance certain elements of this go-to-market strategy will take time to get the results we look for, but some, we hope, we will get earlier results. And over the next few quarters, as we said, we will track and reevaluate. We're not looking at this, "we know exactly what will change the growth trajectory." We know that these are changes we have to make.

If we don't make them, then we're really not looking to ourselves in the mirror and accepting the realities of the market. So that's on the U.S. growth and making sure we address that. In terms of operating expenses, I'm sure you've seen that, up to now, we've been very measured in being on top of the expenses simply because we know we have a long investment journey.

And we're trying to dedicate all our investments in revenue generating as much as we can. We know that this last quarter, we did so much more in terms of effort and activity beyond what we did in Q3, right? So obviously we expect that we're going to see a higher level of operating expense, but the most important part is that we still believe that we're well financed, that we have the right level of cash needed for us to drive the growth and the launches in Europe over the next few quarters. Mike, do you want to add something?

Mike Kalb -- Chief Financial Officer

I'm just going to say U.S. continues to be profitable and that it funds further growth. 

Karim Mikhail -- Senior Vice President and Head of Commercial

Yes. Great. Now going to the global opportunity and the size of the business there: so you've seen that on those 20 additional markets we say that there is a potential up to $1 billion in those 20. And we are not counting there really China, Canada, and the Middle East, Africa region.

Out of those three, the most important opportunity is definitely China. At this point in time, if you look at, I mean, what in statins did in China, we see that between the two statins, we have more than $1 billion of sales. So there is a very, very significant opportunity. And we continue to work with Edding to support the regulatory process where we stand today, but definitely there is another huge opportunity there.

I'm not sure we're ready to sort of quantify that at this stage, but let's get the regulatory approvals because already, as you know, with the Chinese regulatory authorities, you usually have in the process silence, silence, silence. And then at the 11th hour, you get so many questions to address. And we're in that phase of interacting with them intensely, but we'll see how it is going to evolve over time. Thank you, Louise.

Operator

[Operator instructions] And the next question is coming from Paul Choi from Goldman Sachs. Your line is live. 

Paul Choi -- Goldman Sachs -- Analyst

Hi. Thank you, and good morning, and thank you for taking our questions. I want to maybe just ask about gross to net and pricing dynamics here as you see growing market share and impact from the generics here. Can you maybe just comment on what the sequential trend has been in terms of realized net-net price here and just how you think about that potentially being impacted in 2022? 

Karim Mikhail -- Senior Vice President and Head of Commercial

Yes. Thanks, Paul. On the gross to net, I think we communicated twice that we are going to be opportunistic with certain plans to ensure that we eliminate any barriers that exist for the prescription. This is related to the generics but even non-related to the generics, in a way, right? It's an effort that we are making.

And what we've seen so far is that our overall average net price at a national level has been impacted but really, I think, over many quarters, maybe less than 1%. We see that not changing dramatically. So there will be a very, very potential slight decrease in net price, but I would not look at that as anything beyond what would be expected in a regularly competing product in the market, right? I don't see us doing something unusual simply because we believe we don't need it at this stage. It's not a question of -- it's the discussions and negotiations with those trends and making sure that we remove any barriers. 

Paul Choi -- Goldman Sachs -- Analyst

OK. Thank you. That's very helpful color, Karim. And then maybe as a follow-up here, just with regard to the countries in which you filed the dossiers and you could be in a position to have near-term distribution arrangement, can you maybe just update us on where you are on the status of identifying and contracting with a potential partner for those geographies? And when do you think that would potentially be finalized? Thank you very much.

Karim Mikhail -- Senior Vice President and Head of Commercial

Thanks, Paul. So on the question of partnerships. So we already initiated the process for Central Eastern Europe, and we started to engage with a number of countries. Obviously this is a process that takes time because you need to receive the request.

You need to do your diligence. You need to qualify which type of partners you're really going to work with. Are you receiving a country-by-country request? Are you receiving regional requests? What deal is better? Is it better to do a country by country versus regional? So you have to wait until you receive actually all the requests and be able to compare and contrast between them. So this is ongoing for Central Eastern Europe.

We have not yet initiated this process for those 20 additional countries that we are pursuing on the international level. That process has not started. We only have started the process of regulatory submission so that we have an approval, but we are not going to delay for very long that process too simply because the six countries -- and we mentioned some of them. Many of these countries, we believe based on their time lines that we can achieve regulatory approval in 2022.

So because we will achieve that, we will need to have partners ready in these countries. So we plan to initiate this process very early in the year 2022. 

Paul Choi -- Goldman Sachs -- Analyst

Thank you. 

Operator

Thank you. And the next question is coming from Jessica Fye from J. P. Morgan.

Your line is live. 

Jessica Fye -- J.P. Morgan -- Analyst

Hey, guys. Good morning. Thanks for taking my question. Can you break out specifically -- and forgive me if I missed this. What were European revenues in the third quarter?

Karim Mikhail -- Senior Vice President and Head of Commercial

I believe we reported them, but there were very, very little revenues in the third quarter. Off the top of my mind, I think it was maybe $400,000 or something like that -- yes, $200,000. $200,000, so there was very little revenue. I will just clarify a little bit how it works in many of these countries.

So first of all, you cannot your wholesaler contracts and sign them until your price is public, just for you to imagine. Price only became public on September 1. So if you want to engage with wholesalers, that's when the clock starts. So month of September is really a rush to sign wholesale contracts.

Make sure that some of these are going to put orders, that the pharmacies are going to be filled with some supply. The product was not listed on the electronic prescribing system until October 1 not because we decided to delay but because, the German system, they update their electronic prescribing system every quarter and you have to actually submit your request one month prior to that quarter. So we submitted the day of the price because you cannot submit before your price is public. So all of this was almost sequenced by the day to ensure that we have a price listed on September 1 to allow us to be in the electronic prescribing system by October 1.

Having said that, even when you become in the electronic prescribing system, you're still very new to many physicians and the wholesalers are not going to fill up any pipeline until they see key requests from the pharmacists. So the process takes time, especially that this was our first country. And I will remind that we had -- in Germany, we will have the shortest period of prelaunch. In many of the other countries, we're in prelaunch mode today, right? We have medical teams educating.

You see some of -- on the social media stuff, you'll see that our Spanish team is working with a lot of medical events, other teams in the Nordics. So that effort, unfortunately, we didn't have this luxury in Germany. We are now catching up with all of this because of the limited time. So that's really clarifying revenue and revenue expectations within the very first data points for the German launch.

Jessica Fye -- J.P. Morgan -- Analyst

Great. Thank you. 

Operator

Thank you. There were no other questions in queue at this time. I would like to hand the call back to the Amarin management team for any closing remarks.

Karim Mikhail -- Senior Vice President and Head of Commercial

Great. So thank you all so much. We're happy that we were able to address all questions. Thank you for your participation, your contribution.

And we look forward to connect with you again at the next earnings call in 2022. Thank you. 

Operator

[Operator signoff]

Duration: 58 minutes

Call participants:

Mike Kalb -- Chief Financial Officer

Karim Mikhail -- Senior Vice President and Head of Commercial

Yasmeen Rahimi -- Piper Sandler -- Analyst

Roanna Ruiz -- SVB Leerink -- Analyst

Michael Yee -- Jefferies -- Analyst

Louise Chen -- Cantor Fitzgerald -- Analyst

Paul Choi -- Goldman Sachs -- Analyst

Jessica Fye -- J.P. Morgan -- Analyst

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