Q3 2021 Amarin Corporation PLC Earnings Call

Unknown Executive: Welcome to Amerin Corporation's conference call to discuss its third quarter and nine month 2021 financial results and operations. This conference call is being recorded today, November 3, 2021. I would like to turn the conference call over to Michael Cobb, Chief Financial Officer of, 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.

Welcome to Amarin Corporation's conference call to discuss its third quarter and nine months of 2021 financial results and operational updates. This conference call is being recorded today November 3rd 2021.

I would like to turn the conference call over to Michael Kalb, Chief Financial Officer, Ivor and good morning, everyone and thank you for joining us.

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.

Unknown Executive: Examples of such statements include but are not limited to: 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. The 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.

Examples of such statements include but are not limited to.

These statements are based on information available to us today November three 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.

Unknown Executive: 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. Additional information concerning the factors that could cause actual results to differ materially. Please see the risk factors section of our quarterly report on Form 10Q for the quarter ended September 30th, 2021, and our annual report on Form 10K for the year ended December This call is intended for investors in Amaran and is not intended to promote the use of a CIPA. An archive of this call will be posted on Amaran's website in the Investor Relations section.

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 actual results to differ materially.

Please see the risk factors section of our quarterly report on Form 10-Q for the quarter ended September 32021, and our annual report on Form 10-K for the year ended December 31, 2020, which have been filed with the FCC and are available through the Investor Relations section of our website.

At Www Dot Ameren Corp dotcom.

We encourage everyone to read these documents.

Call's intended for investors in Amarin and is not intended to promote the use of vascepa.

An archive of this call will be posted on <unk> website in the Investor Relations section.

Unknown Executive: Kareem McHale, Amarans 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 question. I remind you that a number of audiences 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, on this call, we will attempt to provide constructive information without compromising our competitive and strategic position. I now turn the call over to Kareem McHale for a business update. Good morning, and thank you all for joining us this morning.

Cream, Macau, Ameren, 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'll remind you that multiple audience typically listen to calls of this nature, including existing investors potential new investors employees, Kurt and potential collaborators.

Current and potential competitors.

As always in this call we will attempt to provide constructive information without compromising our competitive and strategic positioning.

I'll now turn the call over to Crema Cal for a view of the business.

Good morning, and thank you all for joining us. This morning, the third quarter of 2021 was a critical quarter for Ameren as we continued to make important strides towards our goal to bring vascepa skipper and CV risk reduction benefits to at risk patients around the world.

Kareem McHale: The third quarter of 2021 was a critical period for Ameren, as we continued to make important strides toward our goal to bring the SEPA, VASCEPA, and its severe risk reduction benefits to at-risk patients around the world. These advances were led by the meaningful progress we made commercializing Vasquetta 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 US, which underscores our commitment to the US market, and it's designed to enhance awareness and drive demand for branded VASIPA and the cardiovascular risk reduction indication.

These advances were led by the meaningful progress we made commercializing best kept that 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 its designed to enhance awareness and drive demand for the branded Vascepa and the cardiovascular risk reduction indication last quarter. When I had just taken over the CEO position.

Kareem McHale: 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 of operational evaluation. Today, I'm happy to report on the progress we've made executing this 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.

With you the vision for our three dimensional growth strategy.

Brett geographic expansion height.

Tight representing diversification and deaths 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 there.

From the global cardio metabolic commercial player we envisioned.

Let me begin with a brief review of our results for the third quarter.

Kareem McHale: 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.

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 'twenty 'twenty.

Kareem McHale: The bulk of this revenue is from U.S. product sales of the SEPA. Importantly, and as Mike will discuss later in the call, our U.S. CEPA franchise remains profitable, and along with our strong balance sheet, continues to support our growth and expansion plan. Now for a deeper dive into the US market. This has been a particularly challenging quarter as a number of market and competitive dynamics impeded the potential for growth in the US.

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 the number of market dynamics.

Dynamics impeded the potential for growth in the U S.

Kareem McHale: First, the impact of the resurgence in COVID-19 delta variance caused patient visits and lab visits to drop by 6% and 7%, respectively, compared with the prior court. Additionally, the lipid market flattened for the first eight weeks of the quarter. Finally, and for the first time, there were two genetics available on the market for an entire court. These dynamics created both the need and the opportunity to reevaluate our strategy. So, let me walk you through our plan.

First the impact of the resurgent COVID-19 Delta variable.

Patient visits and lab visits to dropped 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 genetics 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.

Kareem McHale: We needed to better understand the key gating factors to building more significant adoption of the SEPA for its cardiovascular risk reduction indication and to develop a plan to. Perhaps the biggest driver for growth is improving precision access and engagement. Long before the COVID-19 pandemic hit, access to physicians was declining. For example, according to ZS Access Monitor, access to physicians in 2007 was approximately 80% or 4 out of 5. By the end of 2019, that axis had fallen to about 50%. During the early days of the quarantine in 2020, those levels were a mere 7%, and they currently stand at only 29%.

We needed to better understand the key gating factors to building more significant adoption of vascepa for cardiovascular risk reduction indication and to develop a plan to tackle that.

Perhaps the biggest driver for growth is improving physician access and engagement.

Long before the COVID-19 pandemic hit access to physicians was under decline.

For example, according to D. S access monitor access to physicians in 2007 was approximately 80% or four out of five.

By the end of 2019 that axis had fallen to about 50%.

During the early days of the quarantine in 2020 dose level.

Were a mere 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.

Kareem McHale: 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-only channel approach to enhancing our reach to healthcare professionals, allowing us to target a far greater number of the almost 700,000 state prescribers through high-frequency, customized, and impactful messaging regarding the significant benefits of the SEPA for CV risk reduction. Simply, this creates a model of engagement with prescribers in the ways they want.

Our new strategy employee.

Digital omni channel approach to enhancing our reach to health care professionals.

Allowing us to target a far greater number of the almost 700000 staff and prescribers through high frequency.

I've been 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.

Kareem McHale: 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 in optimizing our educational and promotional efforts to drive healthcare provider and patient use of branded VASIPA in the U.S. These digital platforms include a variety of offerings such as virtual detailing, email campaigns, websites, and medical, 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 VASIPA as the exclusive Icosepent S.O. product.

We intend to significantly increase the use of this robust digital platforms and integrate them with in person visits by our sales force to enhance our reach in customer engagement and improve efficiencies optimizing our educational and promotional efforts to drive health care provider and patient use of branded.

But in the U S.

These digital platforms include a variety of offerings, such as virtual detailing email campaigns websites in medical for tools digital CME, social media and more our next area of focus is managed care, while several other large commercial and Medicare part D payers.

<unk> currently cover Vascepa as the exclusive <unk> 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.

Kareem McHale: We are intensifying efforts to remove remaining barriers to receive a prescription to improve access to patients with real medical needs. We are confident in our ability to drive further volume growth by continuing to focus on enhancing payer. Finally, our last equally important area of focus is to clarify the difference in approved indications between VASIPA and generics. Since 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 generics and educate the market regarding the substitution of SEPA with generics for non-indicated use, particularly at the pharmacy level.

I'm going 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 none indicated uses.

Clearly at the pharmacy level. Our goal is to continue to correct factual inaccuracy within the total prescribing ecosystem.

Kareem McHale: Our goal is to continue to correct factual inaccuracies within the total prescribing ecosystem. From the references Campendia 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 generic usage within their narrow approved label.

From the references companion to retail pharmacy systems to E. Prescribing platforms used by physicians in order to reduce substitution for not 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 genetics usage within their narrow approved label.

Kareem McHale: For all the above reasons, 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 Vasepa prescription for CV risk production.

For all of 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 axis enhancing managed care access.

And optimizing vascepa prescription for CPU based production.

Kareem McHale: Our goal is to deliver a simple, streamlined platform to manage end-to-end slow prescriptions 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.

Our goal is to deliver a simple streamlined platform to manage end to end flow prescription and to ensure and optimize patient and prescriber user experience.

While this new go to market initiatives are in the early days.

We will be driving their implementation with a focused sense of purpose.

<unk> and reevaluating our decisions.

We have three measurements for success execution did we successfully and urgently implement these initiatives.

Kareem McHale: Did we successfully and urgently implement these initiatives? Strategic Impact. Did they deliver their expected impact?

Strategic impact did they deliver their expected impact.

Kareem McHale: revenue, and ultimately, these initiatives produced 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 generic. While in early stages, we believe that such efforts aimed at truly differentiating ourselves versus genetics would have a significant impact on the future potential of SIPA in the US. Turning now to our progress in Europe.

Revenue and ultimately did these initiatives produced greater patient and provider usage, resulting in prescription and revenue increase.

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 an interesting numerous strategic initiatives, which are 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 genetics would have a significant impact on the future potential of vascepa in the U S.

Turning now to our progress in Europe.

Kareem McHale: During the third quarter, Amarin demonstrated its commitment to becoming a global commercial player with its launch of Vasquipa 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 press. We did not even have regulatory approval for the Scape.

During the third quarter Amarin demonstrated its commitment to becoming a global commercial player with its launch of Vascepa in Germany.

As a reminder, when Amazon announced in August 2020 that it would self launch in Europe, We had no legal entities in Europe beyond Ireland, no infrastructure and commercial presence.

We did not even have a regulatory approval for the skip.

Kareem McHale: Today, just a little over one year since that announcement, we have an Emma 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 Zook, 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.

Today.

Just a little over one year since that announcement, we have and Emma approved label that is totally consistent with the broad patient population of reduce it.

We have 15 legal entities in branches, including our commercial happens Zouk, Switzerland three.

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.

Kareem McHale: The launch began 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 country. The medical and commercial teams have made great strides introducing the cardioprotective benefits of Skipa to the German market, with 60 events hosted to date and more than 50 events approved and ready to execute before the year.

The launch that we did with a successful scientific conference that was led by 11 internationally.

Cardiovascular specialist and was attended it.

In person by more than 200 healthcare professionals from Germany with a live stream to many more physicians across the country.

The medical and commercial teams have made great strides introducing the cardio protective benefits of the skipper to the German market with 60 events hosted to date and more than 50 events approved and ready to execute before year end.

Kareem McHale: 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 scientific endorsement from key thought leaders and top societies and our ability to engage, educate, and promote ASCAPA to our targeted patients. We are pleased to report that Vaskepa has been included in Germany's electronic prescribing system, which is updated quarterly effective October 1st. This is an important step in making Sceppa more readily accessible as paper prescriptions represent a very small portion of total prescriptions today.

This is a very proactive plan and our team is making every effort to reach our target audience of both physically and virtually as access to physicians and hospitals in Germany is still limited due to COVID-19.

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 society and our ability to engage educate and promote escape to our targeted audience.

We are pleased to report that the skipper has been included in Germany's electronic prescribing system, which is updated quarterly effective October 1st.

This is an important step in making the skip them more readily accessible as people prescriptions represent a very small portion of total prescriptions. Today, we were honored to be one of three finalists for the gallon is the one picked them on price or pre galea in Germany at prestigious scientific Prides Award.

Kareem McHale: We were honored to be one of three finalists for the Gallinus of the Pergamon Prize or Pre-Gagallia 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 Bynethe fiber for their COVID-19 vaccine. So we are truly honored to have achieved second place, and we have been widely recognized for this achievement in the German press.

Ward it for a particularly innovative medicinal product that has been approved in Germany at the time of submission.

This year's price went to bind tech fiber for the COVID-19 vaccine. So we are truly honored to have achieved a second place and.

And we have been widely recognized for this achievement in the German price.

Kareem McHale: Now at the European regional level, we previously communicated that our goal was 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 Ameren to initiate the negotiation process with the reimbursement agencies of the largest 10 markets in Europe. Those markets are Germany, UK, Italy, France, Spain, Denmark, Sweden, Finland, Norway, and the Netherlands.

Now one of the European regional level, we previously communicated that our goal is to file a 10 market accident dosing by year end.

And I'm proud to report that we have already submitted all time.

This really allows amarin to initiate the negotiation process with the reimbursement agencies of the largest tenant markets in Europe. Those markets are Germany, U K, Italy, France, Spain, Denmark, Sweden, Finland, Norway and the Netherlands.

Kareem McHale: We have already engaged extensively with several of these countries, and in our next earnings call, we will provide an update on our exchanges and expected timelines for reimbursement approval. I can also confirm that all 10 submissions included data demonstrating the uniqueness of Baskapa from a scientific perspective, various countries' specific demographic data to define the eligible patient population based on the label, and the same targeted list pricing of approximately 200 euros or 240 dollars a month.

We have already engaged extensively with several of these countries and in our next earnings call. We will provide an update on our exchanges and expected timelines for reimbursement approvals.

I can also confirm that all 10 submission.

Included data demonstrating the uniqueness of escape 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 200 euros of $240 monthly.

Kareem McHale: 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 European countries, starting with Greece.

The next wave of countries 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.

Kareem McHale: Over the past year, we have been prudent, yet agile, fast, and at the same time measured in how we have built investments and infrastructure in Europe. We are prioritizing and structuring our markets organizations 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 market, we are in the important pre-launch phase, which means that we are establishing relationships with healthcare professionals providing education on the cardioprotective benefits of Skipper and negotiating market access.

Over the past year, we have been prudent yet agile fast and at the same time measured in how we have built the investments in infrastructure in Europe.

We are prioritizing and structuring our market organizations 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, and divest the majority of our targeted market. We are in the important three launch phase, which means that we are establishing relationships with health care professionals, providing education on the cardio protective benefits of the skipper and negotiating market axis.

Kareem McHale: 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. 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.

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.

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 specificity of the individual market and enables us to successfully integrate our digital and face to face channels in one single cross functional.

Play.

Kareem McHale: We are very excited about the opportunity for Breskepa 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 210 billion euros 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. However, setting a new standard in cardioprotective care won't happen overnight.

We are very excited about the opportunity for Vascepa in Europe.

CVD is an increasingly common health problem that caused this $3 9 million deaths per year in Europe, and the European Union 210 billion euros every year.

Would've 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.

I think a new standard in cardio protective care wont happen overnight. However, we have a high level of confidence that we've got to drive the scientific evidence this strategy and the people to make it happen.

Kareem McHale: 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. Beyond the significant multi-billion 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 Cardio Protective Benefits of SEPA 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 to the other 20. Our plan will take place in three ways.

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 cardio protective benefits of Vascepa, the skipper to the top 50 cardio metabolic markets worldwide.

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 waves.

Kareem McHale: The first wave 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 reduced study and the FDA and EMA approvals of the SEPA for the cardiovascular risk reduction indication. We will be specifically seeking our EMA broad-level language in all of these. In most of these markets, we will potentially opt for an agency distributorship partnership.

The first will begin in 2022, when we plan to submit regulatory filings and obtain product approval and up to six countries, including Australia, New Zealand and Israel.

The second wave will come in 2023, when we will seek approval and up to nine countries.

<unk> way 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 approval of Vascepa. The skipper for the cardiovascular risk reduction indication, we will be specifically seeking our M. A broad label language in all of these countries.

And most of these markets, we will potentially opt for an agency distributorship partnerships 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.

Kareem McHale: 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 the Amaran 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 a part, In China, our partner Edding continues to expect to receive approval for Vesipa in mainland China and Hong Kong near the end of 2021. With these approvals, Edding has plans to launch in these territories in 2022.

We believe expanding amarin reach to these additional 20 markets.

The potential to benefit millions of patients at risk of 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 <unk> continues to expect to receive approval of Vascepa in mainland China and Hong Kong near the end of 2021 with these approvals heading has plans to launch in these territories in 2022.

Kareem McHale: As in the U.S. and Europe, Vesipa will launch with the support of the two key Chinese cardiology societies. With the burden of CB 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 Vespa in China. In August 2021, our partner in Canada, HLS Therapeutics, announced a promotional agreement with Pfizer, expanding promotion of the SEPA 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 position audience.

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 Staten collectively selling more than $1 billion that is both a significant medical need and a meaningful market opportunity for vascepa in China.

In August 2021, our partner in Canada, H L. S Therapeutics announced a promotional agreement with Pfizer.

Expanding promotion of Vascepa to primary care physicians in Canada.

HMS existing sales force of approximately 30 field personnel and support staff will remain primarily focused on the specialist physician audience.

Kareem McHale: We believe this new agreement should vote well for the SEPA 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 thoughts on our thoughts around diversification, the height of, and 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 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 excellent and 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 cardio metabolic and obesity space.

We are not limiting ourselves to those that lend themselves to primary care and large populations alone.

Kareem McHale: We're also considering unique assets, including in the specialty and rare diseases spaces, where there remain tremendous unmet needs. We are prioritizing two types of assets, assets with near-term commercial potential and development stage assets that have the potential to significantly enhance and transform our portfolio. As you can appreciate and due to our primary focus on the cardiometabolic space, this process requires time for scientific, commercial, and financial diligence.

We're also considering the unique asset.

Clothing in the specialty and rare diseases spaces, where there remains tremendous unmet need.

We are prioritizing two types of assets.

Assets with near term commercial potential.

In 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 cardio metabolic space. This process requires time and scientific commercial and financial diligence.

Kareem McHale: We are dedicating the needed resources and continue to believe that this is an important lever for future growth. With this overview of our business, let me turn the call over to Mike Cobb, our CFO, for a more detailed discussion of our finances.

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 Cobb: Thanks, Kareem. 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. Vesipa sales as a result of the impact of generic products for Vesipa's initial indication and the ongoing impact of the COVID-19 pandemic.

Thanks cream during the third quarter of 2021, and we reported net total revenue of $142 million.

Credits 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.

Turning to third quarter of 2021, and 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 cells.

A result of the impact of generic products for Vascepa as an initial indication.

Growing impact of the COVID-19 pandemic.

Mike Cobb: In 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 Vesipa in Canada, partially offset by an increase in U.S. Vespa sales of approximately $2.9 million. However, as Cream noted, despite this decrease, the U.S. business continued to be profitable in the third quarter as a result of our continued expense management.

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 eight and a half million dollars. What's included in the initial order in 2020 for the launch of Vascepa in Canada, partially offset by an <unk>.

And U S vascepa sales of approximately $2 $9 million.

However, as cream 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.

Mike Cobb: Despite generic competition in the U.S., we believe that the patient need for Vesipa 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 will 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

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.

Mike Cobb: 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 30th, 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.

Yeah.

Additionally, absent the one time charge of $14 $1 billion related to the transformation of our go to market strategy for the U S. We would've achieved net income in both the three and nine months ended September 32021, which further shows that we have positioned ourselves for growth both in the U S.

Europe.

Additionally, we continue to monitor the ongoing global supply chain issues, which are resulting in inventory supply shortages for numerous companies and products.

Mike Cobb: 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 30th, 2021, Amarin reported aggregate cash and investments of $517.9 million, consisting of cash and cash equivalents of $22.9 million, and liquid short-term and long-term investments of $256.3 million and $38.8 million, respectively.

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 30th 2021, Ameren 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.

Kareem McHale: We believe our current resources and U.S. profitability are sufficient to continue to support launching Viscata successfully throughout Europe and in other international countries throughout the world. With that financial overview, I will now turn the call back to Kareem for closing remarks. Thanks, Mike, for the financial overview. Now that we have shared our roadmap 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 Baskipa in multiple countries in Europe, and obtain regulatory approvals in a number of new countries in 2022.

We believe our current resources in the U S profitability are sufficient to continue to support launching capa successfully throughout Europe and other international countries throughout the world.

With that financial overview, I will now turn the call back to Crane for closing remarks Karim.

Thanks, Mike for the financial overview.

Now that we have shared our roadmap 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.

Exceptionally launch Vascepa in multiple countries in Europe, and obtain regulatory approvals and the number of new countries in 2022.

Kareem McHale: We believe the realization of these ambitions for Amaran 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. Thank you. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while posing your question, you please pick up your handset or listen on speakerphone to provide optimum sound quality. Please hold while we pull for questions. And the first question is coming from Yasmin Rahimi on Piper Sandler. Yasmin, your line is live.

We believe the realization of these ambitions for Amazon will be our collective success.

I'm confident that achieving these goals will build value for the company and enhance shareholder value over time.

That operator, we're ready to open the call for questions.

Thank you ladies and gentlemen, the floor is now opened for questions. If you have any questions or comments. Please press star one on your phone at this time.

How about closing your question you. Please pickup your handset of listening on speaker phone to provide optimum sound quality. Please hold while we poll for questions.

And the first question is coming from he asked me Rahimi from Piper Sandler.

He asked me and your line is nice.

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

Good morning team. Thank you so much for Shanghai, all the updates and congratulations on filing. The 10 does she is ahead of schedule.

I would love to understand a little bit more the cadence of these tenders 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.

Six months.

All of those just yet what potentially be granted any cut start I'll take my market strategy. In these countries. So just give us an idea of the cadence of the 10 guilty etcetera in place that'd 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.

Yasmin Rahimi: So just give us an idea of the cadence of the 10 dossiers that are in place. That would be very helpful. And then the second question is, as you are now in launch Germany, do you still continue to be confident that you would like to launch on your own or is there a change of heart about potentially considering partnership?

On your own or is there a change of parts or potentially considering partnership.

Kareem McHale: And thank you for taking my question. So on the 10 dossiers, you know, it is great that we were able, speaking of Cadence, to already submit the 10, right? You know, the amount of work that is required in specific analyses that those agencies require is huge.

Thank you for taking my questions.

Thank you.

So.

All of the 10 dose is.

It is great that we were able speaking of cadence already yourself.

Right.

The amount of work that is required in specific analysis.

Teens require 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 that would use it so already the fact that we have submitted.

Kareem McHale: 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. Already, the fact that we have submitted this, we believe, is a great milestone. Now, with regard to the next steps, I'm going to generalize because these are 10 countries and all of them have a very different timeline and, you know, 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. An example of these countries are the Nordics.

<unk> is a great milestone.

Regards to the next steps.

I'm going to generalize because these are 10 countries and all of them have a very different timeline and are very different.

You know process and even attitudes towards dealing with the violence, you'll have a group of them that actually have a clock, meaning they're tied to coming back to us.

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 at 90 to 180 days with a response.

Kareem McHale: Usually, most of them have a clock, and they will get back to us usually in 90 to 180 days with a response. Some of these pre-elementary responses are going to be a "no," because that's part of their strategy. And then, you know, we immediately answer their questions, and we move to step two. So this is with regard to, you know, 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.

These preliminary responses are going to be.

Because that's part of that strategy and then you know.

Immediately answered that question.

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 if it doesn't have a clock right.

Kareem McHale: It can take longer or shorter time. But we are in direct engagement on a weekly basis with these agencies. We have received all their questions, and in many cases, we have already responded to them.

We really have a clock it can take longer or shorter time, we are in direct engagement on a weekly basis with these agencies. We did they see from all of them all the questions and in many we have already responded.

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

That's why you saw that in our earnings with just a few minutes ago. We said that by next earnings call. We will be able to provide detailed feedback and a timeline because by next earnings call. We would have received and reaction to what is going how long, it's going to take us, but we're talking about approvals.

Those standards in 2020 doors some might come early.

Come later and it'll all depend on the negotiation.

Kareem McHale: I will remind everybody that if we're going to be. 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 in the long term. So that needs to be taken into account.

Everybody that if we can go and you can see on the price and say Oh, what we're willing to discount experts and we may have a faster reimbursement, but I'm not sure that this is going to build shareholder shareholder value over the long term.

Kareem McHale: So that's on the 10, on the 10 doses cadence and what we expect over the next few months. Now in terms of launch in Germany, we have already planned and invested in a self-launch in Germany. If you compare the investments we put in, the size of the field force, the infrastructure we built, I think it is as robust and as big as many of the key players in the biodefense sector. Do we answer phone calls and talk to partners when they give us information on an ongoing basis, right?

Taking into account. So that's on that then on the tender is cadence and what we expect over the next few.

A few months now.

The 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 is as robust and as big as many of the key players in the Biopharma now.

Do we answer phone calls and we talk to our bottlers when they give us on ongoing basis, right and we would always challenge ourselves, whether we're doing the right things, yes, or no. There's no there's no dogma.

Kareem McHale: 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. You know, we're launching at this point in time in Germany; it's still, you know, pretty restricted because of COVID. We have not reached out to everybody in our target audience until today, uh, 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.

Is it business.

You know we're launching at this point in time in Germany.

You know 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.

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 them at this point in time is really the the support and endorsement that we're getting from the society from the scientific leaders and we believe that the ramp up.

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

It will happen slowly but surely.

Roanna Clarissa H. Ruiz: Thank you, Karie. Thank you, thank you. The next question is coming from Rowana Ruiz from SVB Lear. Rwanda, your line is live.

Thank you Corinne.

Right.

Thank you.

The next question is coming from Roanna Ruiz from SBB Leerink or a lot of your line is live.

Roanna Clarissa H. Ruiz: Great, thanks. Morning, everyone. A quick question on Germany.

Great. Thanks, Good morning, everyone. A quick question on Germany, I was curious if you could elaborate on the number of physician targets youre, possibly focusing on and what types of practitioners appear to be early prescribers that best Capa and specifically I'm wondering if there no more high volume prescribers and statin.

Roanna Clarissa H. Ruiz: I was curious if you could elaborate on the number of physicians you're possibly focusing on and what types of practitioners appear to be early prescribers of Veskepa. Specifically, wondering if they're, you know, more high volume prescribers of statins. Are they more specialists or generalists, et cetera, whatever color you can provide.

Are they more specialists are generalists et cetera, whatever color you can provide.

Kareem McHale: Thank you, Ron. So to give more granularity on the German law, we did target, you know, every specialist that really is involved in cardiomephaboleic 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 allows us to cover 80% of the business, which is in the tens of thousands.

Thank you Ron so they give more granularity on the German law, so we target.

Every specialist that really is involved and he comes to myself well. They can talk to you about some of the risk management. So basically between hospital and private cardiologist, we really cover basically 100% in terms of GP practices.

We cover the percentage does allow us to cover 80% of the business.

The chart in the tens of thousands at this point in time, so it's a pretty significant target audience, that's why with the restriction.

Kareem McHale: At this point in time, 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 to target. But more importantly, who are in the innovation business, who are the ones who very readily prescribe new products that are, you know, not the ones to do Euro 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. You know, definitely because of the restriction.

Actually I had to prioritize because the way, we segmented and targeted volume. So the potential of these initiatives are the key criteria to target, but more importantly, who are in the innovation business are the ones, who very readily prescribed new products that are.

You know not the one to two euro styled and Theyre willing to innovate and go beyond what is traditional to support their patients. So this is the last.

That's when he was.

You know definitely.

Because of administration, we had to focus on how we're talking to M. D C.

Kareem McHale: We have to focus on our targets A and B, not C and not D. Just because for us to deliver prescriptions, you have to visit a 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 is on the market, we hardly were able to get to the three, maybe, or some may be foreign saw that we communicated the number of meeting events that we're having because that's another strategy to reach out to physicians.

Just because for us to deliver.

Descriptions, you'll have to visit their physician.

E E four five times right.

That's the bare minimum that you need to deliver it.

Engage to truly have a dialogue.

And you know until the product was on the market.

We were able to get to the three maybe or some maybe for it so that.

So that we communicated the number of meeting event, that's what having because that's another strategy to reach out to physicians.

Kareem McHale: Instead of saying it's one-on-one, we do 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 one region to another because that could get those physicians who are not open to go to a physical meeting instead of driving to a conference 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 see that we said, you know, 60 meetings up to now, these are the sort of events that we organize.

Saturday ingots.

You know our speaker tour after our launch event by the way we had a very significant effort to do.

German speaking with a number of speakers who went from region to another because that couldn't get those physicians who are not open to go to a physical meeting instead of diving traveling and being with for example, 200 other physicians if they see that the group is 2025 30, they are more comfortable.

This is what we've done when you saw that we said 60 60 meetings up to now they started to sort of events that we execute.

Kareem McHale: Going back to your question about how many are early adopters, the early adopter range is in the single digits of the German target audience, okay? So, 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.

Going back to your question about how many of our early adopters.

The range is in the single digits.

Of the German target audience. Okay. So just also just to see it.

And 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.

Roanna Clarissa H. Ruiz: Okay, great. That's really helpful. And then maybe 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 and how you adapt your strategy in the next quarters?

Thank you Lauren.

Okay, Great. That's really helpful. And then maybe switching gears to the U S and I was curious what metrics are you you know internally tracking to understand how that new U S. Go to market strategy is gaining traction and how might that inform your you're pushing pulse on how you adapt your strategy in the next quarters.

Kareem McHale: Sure, great question. So, you know, the metrics we're focusing on really are the ones that relate to what we know is critical at this stage. As you heard, we said that we know it is incredibly difficult to drive growth if you don't have the breadth and the depth of the engagement with the target order. We did have a large fuel force, but despite that, and because of the access limitations at the physician level, we were not able to engage with them because the rule was not open.

Sure Great question so the.

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 engagement with the target audience.

Did you have a large field force, but despite that and because of the access limitations at the physician level, we would've not been able to engage with them because not all of it. So what we did was to redefine a number of territories, where our reps and our sales managers can actually engage.

Kareem McHale: So what we did was to redefine a number of territories where our reps and our sales managers could 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. Are our teams able to meet, discuss, and move, you know, so the breadth of the reach but also the depth, meaning how many prescriptions on average we are able to drive?

They're not going to spend their day knocking on doors that are closed so.

A very important metric is the level of engagement.

To deliver on.

He was able to me discuss and you know and many of those so the breadth of reach but also the depth, meaning how many prescriptions on average we are able to drive up to now 50% of Vascepa prescription they've been by only 6000 prescribers empty.

Kareem McHale: Up to now, 50% of the CEPA prescriptions are driven by only 6,000 prescribers in the U.S. That's why we believe that there is an opportunity that if we expand and broaden the engagement and, you know, and, you know, and, even have deeper engagements, we can drive this number to be higher and the number of scripts delivered by physicians. So that's one metric relating to engagement.

That's why we believe that there is some opportunity there.

We expand and broaden engagement and you know.

Even have deeper engagement that we can drive this number could be higher than the number of scripts deliberate by physicians. So that's one one metric relating to engage with the second one has to do obviously with the situation with the generic because today.

Kareem McHale: The second one has to do, obviously, with the situation with generics, because today what we are seeing is that a significant number of patients who are indicated for cardiovascular risk indication, which is, you know, an indication not approved for genetic testing, are still getting generics. And, you know, there are things that we can do as Amaran about this, and there are things that are out of our control. Let's face it.

We are seeing is that.

A significant number of patients who are indicated for cardiovascular risk and vacation, which as you know.

You should not approved for the generic are still getting the generic and you know there are things that we can do is eminent about this and there are things that are out of our control let's face it.

Kareem McHale: If, you know, 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, you know, the payers will use it, and we have challenges. That's not in our control. There is a legal sort of, you know, pass to deal with this.

If you know if the genetics continue to supply.

The market beyond what is needed.

Very clear beyond what is needed because the indication size that they have literally 7% to 8% of the market, but if they continue to push more supply.

The figures will use it and we have challenges.

Within our control that is illegal sort of.

I'll pass to deal with this.

Kareem McHale: What is in our control is what we do 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?

It's 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.

Rejections or are we getting are we truly getting at the end of the day every prescription is written by a physician.

Kareem McHale: Are we truly getting, at the end of the day, every prescription that is written by a physician fulfilled by 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. It's a difficult question, Rwana, but I hope I've clarified it.

The pharmacist at the end of the day and that's why we have a number of initiatives to drive.

Fulfillment to be much higher. So these are really the metrics we're focusing on.

It's a difficult question, but I hope I hope I clarified.

Yeah that was helpful. Thanks.

Roanna Clarissa H. Ruiz: Yep, that was helpful. Thanks.

Thank you.

Next question.

Michael Yee: The next question is coming from Michael Yee from Jeffries. Michael, your line is very loud.

The next question is coming from Michael Yee from Jefferies.

Michael Your line is live.

Michael Yee: 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 dispensing. Can you just remind me briefly where those were, whether there was any update on the progress of that? I think that would be an important potential development in the future, so just remind me of that.

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 and in part trying to enforce on label prescription dispensing can you just remind me briefly we are in the ocean or whether there was any update on the proceedings of that.

I think that would be an important potential development features so just remind me on that if there's any traction there and then second question is I thought you are flying around business development.

Michael Yee: And then the 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 then 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?

What's really interesting and you gave some pretty pretty good specifics cardio metabolic obesity, especially rare diseases and I think I'm aware of some of those products out. There can you just comment on how our urgent or how near term in 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.

Kareem McHale: I think it could be quite interesting to leverage your sales force. So maybe just talk about that because I think that could be important. Thank you. Perfect. Thank you, Mike.

Thank you.

Thank you Mike.

So all of the law, so let's clarify we actually.

Kareem McHale: So on the lawsuits, let's clarify that we actually do not have any process against any pharmacy or pharmacy chain. We actually have one against, you know, a genetic supplier and a payer, specifically health insurance. That's what we have in place, and that's what we continue to pursue. You know, there was at a certain point in time a request from the two of them to basically dismiss the case, but that was a Massachusetts opinion to deny this request for dismissal. Then the district judge asked for an actual hearing.

Do not have any any process against any pharmacy or pharmacy chain, we actually have one again.

You know a genetic supplier and payer specifically, helping that that's what we have in place. This is what we continue to pursue that was at a certain point in time a request from.

The two of them to basically dismissed the case that it was a magistrate opinion.

Deny this request for this missile then the district judge ads for an actual hearing took place two weeks ago or a bit more and we're expecting you.

Kareem McHale: This took place two weeks ago or a bit more, and we're expecting, you know, a decision by the judge on accepting or rejecting the request for dismissal in the next few weeks. In any case, you know, if it's accepted, we would appeal, and we would. continue to fight this, and if it's denied, we also will continue with that because we believe that we have a very strong position in terms of, you know, our real standing on this issue. So that's the first question. Okay, very helpful on that part.

You know.

Vision by the judge on accepting or rejecting the request for dismissal in the next few weeks in any case.

If accepted we would have to be and we would continue to fight this.

We also continue with that because we believe that we have a very strong position in terms of getting a lot of legal spending on this issue. So that that's on the first question is is that yep.

Okay. That's very helpful in that park Green Yeah on.

Kareem McHale: Great. Yeah. On the second question with regard to diversification, we wanted to add more color to this earnings call, you know, 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 timelines 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 incredible equity in the cardiometabolic obesity space. These are the leaders, the thought leaders, the scientific authorities that we're engaged with.

On the second question with regards to diversification, we wanted to add more color in this earnings call.

The almost qualified that type of effort that we are making and what we're starting to think this was not intended in any way to somehow highlight timelines or even urgency because we get the question very regularly what are you looking at what time, you're focused on and we wanted to be clear that we believe would've building.

An incredible equity can be cardio metabolic cookies.

These are the leaders the thought leaders in scientific authority, that's way to engage with them today, we're building credibility with building equity. So we have no intent.

Kareem McHale: And today we're building credibility, we're building equity. So we have no intent to spread ourselves thin and go into some therapy areas that will take us away from all of that while we're launching the CFA and the SCPA; I'm saying launching the CEPA because I think we still launch more than well. Right. So that's the focus on cardiometabolic and obesity. Now, if we say we're so clear about this, you know, focus area, we cannot say, oh, but then let's only focus on, you know, primary care style, large population assets, because that limits our sphere of assets dramatically.

Spread ourselves thin and go under some therapy areas that will take us away from all of that while we're launching vascepa in Muscat St launching vascepa, because I think we're still in launch mode anyway right. So so that's the focus on cardio metabolic adobe's.

Now if we say was so clear about this.

You know focus area, we cannot say oh, but that's only focus on primary care style large population.

Limit.

Our fear of assets dramatically.

Kareem McHale: And we believe that whether it is in primary care specialty or rare diseases, thought leadership, and 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 this space.

And we believe that whether it is in primary care specialty all rare diseases.

Leadership.

[laughter] associations are more or less the theme.

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 industry. So that's with regards to diversification I hope it was sufficient.

Louise Alesandra Chen: So that's with regard to diversity. I hope this was sufficient. Thank you. Thank you. Thank you. The next question is coming from Louise Chen from Cantor. Louise, your line is open.

Mike.

Thank you.

Thank you.

Thank you.

The next question is coming from Louise Chen from Cantor.

Luis your line of sight Hi, Thank you for taking my questions here.

Louise Alesandra Chen: Hi. Hi, thank you for taking my questions here. So the first question I had for you is, you know, you 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 could give us a little bit more on when you think you might see them.

So first question I had for you is you know 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 can give us elaborate a little bit more on when you think you might see that.

Louise Alesandra Chen: And then how should we think about the operating expenses and fourth quarter 20

And then how should we think about the operating expenses in fourth quarter 'twenty. One I know you talked about a little bit of Lumpiness. So maybe if you could help us there 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'll also have China, and Hong Kong and other areas of the world. So when you look at.

Louise Alesandra Chen: You talked about a little bit of lumpiness, so maybe if you could help us there or just give us some broad strokes, it would be great. And then, just one 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 go? Great, thank you, Louise.

The global opportunity, where do you think peak sales could get too. Thank you.

Great. Thank you Louise so 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.

Kareem McHale: So first on US sales, I mean, our announcement that came out a month or so ago about the change in the auto market strategy is 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; with change comes a bit of disruption, right, temporarily. Let's be very real.

Go to market strategy.

To respond to the challenges that we've seen so we're very conscious of 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.

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 group.

Kareem McHale: I mean, our 300 people that we have on the field today are incredibly qualified. We believe strongly that they are the right group, you know, to lead this next phase of growth. Having said that, for many of them, they're going to have a 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, and they need to establish working relationships, that they're going to establish working relationships. They need to understand where those physicians are on the prescribing continuum. Are they believers? Are they non-believers?

And that for many of them, they're going to have 50% change in their target audience right. They're gonna be now in this first month meeting people that they have not met before.

Yeah.

Abbott is working relationship that they need to understand where are those physicians prescribing continuing unabated believers they number there.

Kareem McHale: What do they need to do? So there will be a period where we make this foundational effort to say, okay, 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.

To do so there will be periods, where we're making this foundational effort to say okay. This is.

And your page and you add this isn't new to you, let's go and see how far we can go so it will take US a couple of quarters, but basically you know anchor ourselves and get this he would go to market.

Kareem McHale: So it will take us, you know, a couple of quarters to basically anchor ourselves and get this new go-to-market strategy to operate. And at the same time, we are starting very aggressively all the digital Omnich Channel as early as, you know, a few weeks ago, simply because that was one part of the strategy that we could press a button and immediately engage with a far broader group. So this is to say we're making every effort to advance.

Our strategy to operate at the same time, we are starting very aggressively all the digital omni channel.

As early as you know from weak.

Because that towards one part of the strategy that we could pass on the button and immediately engage with affordable vertical. So this is to say, we're making every effort to advance.

Kareem McHale: 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 orders, as we said, we will track and re-evaluate. We're not looking at this, but 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 in the mirror and accepting the realities of the market.

Certain elements of this go to market strategy will take time to get.

Results, we look forward, but some we hope we will get the result.

Results in over the next few orders as we said we will go back and reevaluate we're not looking at Oh, you know exactly what will change.

The growth trajectory, we know that these are changes we have to make if we don't make them that we're really not looking to ourselves in the mirror and accepting the realities of the market.

Kareem McHale: So that's on 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, you know, 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 to revenue generation as much as we can. We know that in this last quarter we did so much more in terms of effort.

So that's that's on the U S growth.

Sure we addressed that in terms of operating expenses I'm sure you've seen up to now we've been very.

Very measured and.

Being on top of the expenses simply because we know we have a long investment journey.

And we're trying to dedicate.

All of 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 you know a higher a higher level of operating.

Kareem McHale: and activity beyond what we did in Q3, right? So obviously, we expect that we're going to see a higher level of, you know, operating expenses. But the most important part is that we still believe that we're well financed, that we have, you know, the right level of cash needed for us to drive growth and launches in Europe over the next few quarters. Mike, do you want to add something?

Do you think expense.

The most important part is that we still believe that we're well financed.

Have the right level of cash you need it for us to drive the growth and the launch in Europe over the next few quarters.

Mike do you want to add something I was just going to say U S continues to be profitable in that fund further growth.

Mike Cobb: I'm just going to say the U.S. continues to be profitable, and that funds further growth. Great. Now, going to the global opportunity and the size of, you know, the business there, so you've seen that in those 20 additional markets, we say that there is, you know, a potential for up to $1 billion in those 20, and we are not counting, really, China, Canada, and, you know, the Middle East and Africa region. Out of those three, the most important opportunity is definitely China.

Right now.

Going to the global opportunity and the size of.

The benefit there so you've seen that on those 20 additional markets, we say that there is a.

A potential up to 1 billion in those 'twenty 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 in China.

Mike Cobb: At this point in time, if you look at, I mean, what statins did in China, we see that between the two statins, we have more than $1 billion in sales. So there is a very, very significant opportunity. And we are, you know, we continue to work with adding to support the regulatory process where we stand today. But definitely, there is another huge opportunity. I'm not sure we're ready to sort of quantify that at this stage.

At this point in time, if you look at I mean, what stack them to stay in China, we see that between the two standards, we have more than 1 billion.

Dollar of sales. So there is a very very significant.

The opportunity.

And we are you know we continue to work with adding two to support the regulatory process, where do we stand today.

But definitely there is another huge opportunity there and I'm not sure we're ready to sort of quantify that at this stage, but let's get the regulatory approvals because already.

Mike Cobb: But let's get the regulatory approvals because, as you know, with the Chinese regulatory authorities, you usually have in the process, silence, silence, silence, silence. And then at the 11th hour, you have so many questions to address, and we're in that phase of interacting with them intensely. We'll see how this is going to evolve over time.

With the Chinese regulatory authorities are usually having the process, Thailand, Thailand, Thailand, Thailand, and then at the 11th hour you got so many questions to address and we're in that phase of interacting with them intensely.

How is this going to evolve over time.

Kareem McHale: Thank you, Louise. Thank you. Once again, ladies and Chapman, if you wish to enter the queue, you can press star 1 on your phone at this time. And the next question is coming from Paul Choi from Goldman Sachs. Paul, your line is live.

Thank you Louise.

Thank you.

Okay.

Once again, ladies and gentlemen, if you wish to enter the queue. You can press star one on your phone at this time and the next question is coming from Paul Choi from Goldman Sachs. Paul Your line is flash.

Paul Choi: Hi, thank you, and good morning, and thank you for taking our questions. I want to maybe just ask about growth in net and pricing dynamics here as you see growing market share and impact from 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? Yeah, thanks, Paul. You know, on the growth to net, I think we communicated twice that we were going to be opportunistic with certain plans to ensure that we eliminate any barriers that exist for the prescription. This is, related to genetics, but even nonrelated to genetics in a way, right?

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 that what the sequential trend has been in terms of realized net price here.

How do you think about that potentially being impacted in 2022.

Yeah. Thanks, Paul.

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 first question. This is <unk>.

Related to the generics, but even number of genetics and away right.

Kareem McHale: It's an effort that we are making. And what we've seen so far is that, you know, our overall average net price at the national level has been infected, but really, you know, 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?

We are making and what we've seen so far is that.

Our overall average net price at the national level.

It's been impacted but really I think over many quarters, maybe less than 1%, we see that not changing dramatically. So there won't be a very very potential slight decrease in net price, but I would not look at that there's anything.

What would be expected in a regularly competing.

Product in the market right I don't see us doing something unusual simply because we didn't we don't need it at this stage is it's not a question of is it.

Paul Choi: I don't see us doing anything 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 plans and making sure that we remove any barriers. Okay, thank you. That's very helpful, Color Cream.

Discussions and negotiations with those plans and making sure that we can move any barriers.

Okay. Thank you that's very helpful color cream and then maybe.

Kareem McHale: And then maybe, as a follow-up here, just with regard to the countries in which you file the dossiers and you could be in a position to have near-term distribution arrangements, 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 you think that would potentially be finalized? Thank you very much. Thanks, Bob.

As a follow up here just with regard to the.

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.

Kareem McHale: So on the question of partnership, we have already initiated a process for Central and Eastern Europe, and we started to engage with a number of countries. You know, obviously, this is a process that takes time because you need to receive the request, you need to do your diligence, you need to, you know, qualify which type of partner you're really going to work with. Are you receiving country-by-country requests? Are you receiving regional requests? What do you think?

So so on the on the question of partnership So we already initiated the process to central Eastern Europe, and we started to engage with a number of countries.

You know.

This is a process that takes time, because you need to issue the request.

Diligence you need through it'll qualify which type of partner, you're even going to work with are you receiving a country by country requests.

Regional requests.

What do you feel is better is it better to do a country by country versus regional so you'll have to wait until you receive actually all older equipment and be able to compare and contrast between them.

Kareem McHale: is better. Is it better to do a country by country versus regional? So you have to wait until you actually receive 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 yet. We have only started the process of regulatory submission so that we have an approval, but we are not going to delay that process for very long, you know, that process too, simply because the six countries, and we mentioned some of them, many of these countries, we believe, based on their timelines, that we can achieve regulatory approval in 2022.

Ongoing for central and Eastern Europe, we have not yet initiated this process for those 20 additional countries that we are pursuing on the international level that process at months target. We only have started the process of regulatory submission. So that we have an approval, but we are.

I'm not going to delay for very long you know that process to simply because the six countries and.

And we mentioned some of them may.

Many of these countries, we believe based on their timelines that we can achieve regulatory approval in 'twenty to 'twenty. Two so because we will achieve that we would need a partner is ready.

Kareem McHale: So because we will achieve that, we will need partners ready in these countries. So we plan to initiate regulatory approval this process very early in the year 2020. Okay, thank you very much. Thank you. And the next question is coming from Jessica Fye, from J.P. Morgan. Jessica, your line is live. Hey, guys.

These countries. So we plan to initiate this process very early in the year 2020.

Okay. Thank you very much.

Thanks.

Thank you and the next question is coming from Jessica Fye from J P. Morgan Jessica your lineup lives.

Jessica Macomber Fye: Hey guys, good morning. Thanks for taking my question. Can you break it out specifically, and forgive me if I missed this, what were European revenues in the third quarter?

Hey, guys. Good morning, Thanks for taking my question can you.

Break out specifically and forgive me if I missed this what our European revenues in the third quarter.

Yeah.

Jessica Macomber Fye: I believe we reported them, but there were very, very few revenues in the third quarter. On the top of my mind, I think it was maybe 400,000 or something like that. Yeah, 200,000. 200,000. So, you know, there was very little revenue. I will.

I believe we reported them, but they were very very little revenues in.

The third quarter.

The top of my mind, I think it was maybe 400000 or something like that.

Yes, 200000 to 100000, so you know.

Was very little revenue.

Kareem McHale: Just clarify a little bit how it works in many of these countries. So, first of all, you cannot receive your wholesaler contracts and sign them until your price is public, just so you can imagine. The prices only became public on September 1st. So if you want to engage with wholesalers, that's when the clock starts. So, you know, the month of September is really a rush to sign wholesaler contracts, make sure that some of these are going to place orders, and that the pharmacies are going to be filled with some supply.

Just to.

Clarify a little bit how it works in many of these countries. So first of all you cannot put to give you a wholesaler.

Contracts and sign them continue with prices public just for you to imagine price only became public on September 1st.

So if you want to engage with all that's when the clock starts. So month of September is really a rush to sign wholesaler contracts ensure that some of these are going to put all of those.

Pharmacy is gonna be filled with some supply the product was not listed on the electronic prescribing system until October 1st 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 for one month.

Kareem McHale: The product was not listed on the electronic prescribing system until October 1st, not because we decided to delay, but because the German system updates their electronic prescribing system every quarter, and you have to actually submit your request one month prior to that quarter. So we submitted it on the day of the price because you cannot submit before your price is public.

Prior to that quarter. So we submit the day of the price because you've got not something before your price is public so all over there.

Kareem McHale: So all of this was almost sequenced by the day to ensure that we had a price listed on September 1st to allow us to be in the electronic prescribing system by October 1st. Having said that, even when you get into the electronic prescribing system, you're still very new to many physicians, and the wholesalers, you know, are not going to fill up any pipeline until they see key requests from the pharmacists.

This was also sequenced bite that day to ensure that we have a price list is on September 1st to allow us to be in the electronic prescribing system by October 1st having said that even when you become electronic prescribing system Youre still very new physicians and the wholesalers.

I'm not going to fill up any you know pipeline until they see key request from the pharmacy. So the process takes time.

Kareem McHale: So the process takes time, especially since this was our first country. And I'll remind you that we had, you know, in Germany we will have the shortest period of pre-launch. In many other countries, we're in pre-launch mode today, right? We have medical teams educating. If you see some of the social media stuff, you'll see that our Spanish team is working with a lot of medical events, you know, other teams in the Nordics. So that effort, unfortunately, we didn't have this luxury in Germany.

Especially this was our first country and all of the mind that we had.

In Germany, we will have the shortest period prelaunch and many of the other countries. We haven't prelaunch mode. Today right. We have medical teams educating excuse me some of you know on.

The social media stuff you will see that our finished he was working with a lot of medical event you know other teams in the north East So that's.

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 you know.

Jessica Macomber Fye: We are now catching up with all of this because of the limited data points. So that's really, you know, clarifying revenue and revenue expectations within the very first data points for the German law. Great, thank you. Thank you. There will be no other questions in Q at this time. I would like to hand the call back to the Amerin Management team for any closing remarks. Great, so thank you all so much. We're happy that we were able to address, you know, all questions.

Clarifying revenue and revenue expectations within the very first.

You know data points for the German launch.

Okay. Thank you.

Thank you 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.

Great. Thank.

Thank you all so much.

We're happy that we were able to address all of them.

Jessica Macomber Fye: Thank you for your participation and your contribution, and we look forward to connecting with you again at the next earnings call in 2022. Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your lines at this time and have a wonderful day. Thank you for your participation.

Questions. Thank you for your participation your contribution and we look forward to connect with you again at the next earnings call in 2020. Thank you.

Thank you ladies and gentlemen, this does conclude today's conference call. You may disconnect. Your lines at this time and have a wonderful day. Thank you for your participation.

Okay.