Q3 2020 Amarin Corporation PLC Earnings Call

Welcome to Amarin Corporation conference call to discuss its third quarter 2020 natural result operational update.

Operator: Welcome to Amarin's Corporation Conference Call to discuss its 3rd Quarter 2020 Financial Results and Operational Update. This conference call is being recorded today, November 5th, 2020. I would now like to turn the conference over to Elizabeth Schwartz, Senior Director of Investment Relations for Amarin. Please proceed.

This conference. This call is being recorded today November 5th 2020.

I would now like to turn the conference over to Elizabeth Swartz Senior director of Investor Relations for Amarin. Please proceed.

Elizabeth Schwartz: Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of the SEPA prescriptions, SEPA product and licensing revenues, costs, gross margin, and other commercial metrics. Our current plans and expectations regarding spending, including expenditures for promotion of the SEPA and for purchases of additional supplies of the SEPA. Our current expectations regarding the adequacy of our financial resources.

Please be aware this conference call will contain forward looking statements that are intended to be covered under the safe Harbor provided by the private Securities Litigation Reform Act.

Examples of such statements include but are not limited to our current expectations regarding our commercial and financial performance, including levels up as people prescription, but people product and licensing revenue cost gross margin and other commercial metrics, our current plans and expectations regarding spending including expenditures for promotion of a steep.

As for purchases of additional.

Our current expectations regarding the adequacy of our financial resources, our current plans and expectations for product revenue growth sales force productivity and product promotion. Unlike the cobot Nike and the potential added attention to cardiovascular risk reduction drugs like this keep up as a result of COVID-19.

Elizabeth Schwartz: Our current plans and expectations for product revenue growth, sales force productivity, and product promotion in light of COVID-19 and the potential for added attention to cardiovascular risk reduction drugs, like the SEPA, as a result of COVID-19. Our current plans and expectations related to patent litigation, and expectations related to the potential loss of generic versions of the SEPA by generic companies and by ourselves. Our current expectations for regulatory reviews outside the United States regarding SEPA approval.

Our current plans and expectations related to patent litigation and expectations related to the potential loss of generic versions of the people buy generics companies a buyer or seller.

Current expectations for a regulatory reviews outside the United States regarding the fee pool.

Elizabeth Schwartz: Our goals regarding the timing, scope, and success of international expansion, including expectations regarding our ability to launch the SEPA in Europe and our expectations in China for clinical trial results and the potential to bridge reduced results in labeling and promotion of the SEPA through our partner in China. Our current plans and expectations regarding VISIPA exclusivity outside the United States, including Europe and China, our current plans for commercial expansion in the United States with and without the entry of potential generic competition, and our current plans and expectations regarding clinical study of VISIPA related to COVID-19 These statements are based on information available to us today, November 5, 2020. 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 too much reliance on these statements. We assume no obligation to update these statements as circumstances change.

Goals regarding the timing scope and successive international expansion, including expectations regarding our ability to launch this year in Europe, and our expectations in China for clinical trial results the potential to bridge reduce it results in labeling a promotional with either through our partner of choice.

Our current plans and expectations regarding the sheep exclusivity outside the United States, including Europe, and China, a coke sales for a commercial expansion of the United States with and without entry of potential generic competition and our current plans and expectations regarding clinical study EPS related to Carbonite team. These.

These statements are based on information available to US today November <unk> 2020, we may not actually cheaper goals carry out our plans or intentions or meet the expectations disclosed in our forward looking statements.

Actual results or events could differ materially so you should not place undue reliance on these statements.

We assume no obligation to update these statements as circumstances change our forward looking statements do not reflect the potential impact of significant transactions when they enter into such as mergers acquisitions dispositions joint ventures or any material agreement that we may enter into amend or terminate for additional information concerning the factors that could cause actual results to differ materially.

Elizabeth Schwartz: Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate. For additional information concerning the factors that could cause actual results to differ materially, please see the risk factors section of our annual report on Form 10-K for the year ended December 31, 2019, and the Form 10-Q filed for the quarter ended September 30, 2020. These documents have been filed with the SEC and are available through the investor relations section of our website at www.amerincorp.com.

Please see the risk factor section of our annual report on form 10-K for the year ended December Night December 31st 2019, and the form 10-Q filed for the quarter ended September Thirtyth yourself, then 20.

These documents have been filed with the FCC and are available through the Investor Relations section of our website on camera core dotcom. We encourage everyone should we decide to seize document it's called intended for investors in Amarin and is not intended to promote the use of the people outside its approved indication.

An archive of this call will be posted on the Amarin website also on the Investor Relations section.

Elizabeth Schwartz: We encourage everyone to read these documents. This call is intended for investors in Ameren and is not intended to promote the use of this FIPA outside its approved indication. An archive of this call will be posted on the Amarin website, also in the Investor Relations section. Making prepared remarks on today's call will be John Farrell, President and Chief Executive Officer. Craig Granowitz, Chief Medical Officer, and Michael Kalb, Chief Financial Officer. After prepared remarks, we'll respond to questions. Some of you submitted questions in advance, and where practical, we have tried to include responses in our prepared comments.

Prepared remarks on today's call will be John Thero, President and Chief Executive Officer.

Hi, Granowitz Chief Medical Officer, Unlike Oak Howe, Chief Financial Officer after prepared remarks, we'll respond to questions Hello.

Well have you submitted questions in advance and where practical we have tried to cover responses in our prepared comments.

I remind you that typically lifting two calls of this nature are multiple audience.

Including existing investors potential new investors employees regulatory authorities current and potential collaborators incurring potential competitors as always in this call. We will attempt to provide constructive information without compromising our competitive and strategic positioning.

I will now turn the call over to John Thero, President and Chief Executive Officer of Amarin John.

Good morning, and thank you for joining us as we announced in our press release earlier. This morning gambling reported record revenue in the third quarter.

Since our last Investor Conference call, we made progress across a number of areas key to our growth strategy, including advancing our plans for commercial launch of us you've been Europe, increasing promotional just cheap in the United States and publication and presentation at several robust data set and supported the steep as demonstrated car.

Elizabeth Schwartz: I remind you that typically, there are multiple audiences listening to calls of this nature, including existing investors, potential new investors, employees, regulatory authorities, 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 positioning. I will now turn the call over to John Thurow, President and Chief Executive Officer of Amarin.

Neovascular risk reduction and multi factorial mechanisms of action.

Going to our revenue.

Achieved a year over year total net revenue increased 39% in the third quarter and 56% for the first nine months of 2020.

The 39% growth in the third quarter represent significant growth from the second quarter, but remains below the greater than 100% year over year growth reported in the first quarter point 20.

John Thurow: Good morning, and thank you for joining us. As we announced in our press release earlier this morning, Amarin reported record revenue in the third quarter. Since our last investor conference call, we made progress across a number of areas key to our growth strategy, including advancing our plans for the commercial launch of Visepa in Europe, increasing promotion of Visepa in the United States, and publication and presentation of several robust data sets in support of Visepa's demonstrated cardiovascular risk reduction and multifactorial mechanisms of action. Now, turning to our revenue. We achieved a year-over-year total net revenue increase of 39% in the third quarter and 56% for the first nine months of 2020. The 39% growth in the third quarter represents significant growth from the second quarter but remains below the greater than 100% year-over-year growth reported in the first quarter of 2020, prior to the broad effects of COVID-19 that slowed patient visits to their doctors. These positive results reflect the effectiveness of the FIPA in lowering cardiovascular risk in high-risk patients and further improved payer coverage. Moreover, this growth is a testament to the drive and dedication of our talented team of employees at Amarin who continue to persevere despite the challenging headwinds we've all faced with the COVID-19 pandemic. Based upon TRX data from Symphony Health.

Wire to the broad effects to COVID-19, that's slowed patient visits to their doctors.

These positive results reflect the effectiveness of the feedback and lowering cardiovascular risk in high risk patients instead.

And further improved payer coverage.

Moreover, this growth is a testament to the drive and dedication of our talented team of employees or the amarin will continue to persevere. Despite the challenging headwinds weve all faced with a COVID-19 pandemic.

Based upon Trx data from Symphony Health.

The steep growth during the third quarter and year to date continued to outpace the growth rates the more established drugs with positive cardiovascular outcomes data that's just that.

Moreover.

This years growth in these periods also outpaced the growth of nearly all branded drugs for which positive cardiovascular outcome results were reported within the past four years.

While the C., but does not compete against these other drugs.

We are proud that in these challenging COVID-19 times and despite commercial spending to promote the steep up being lower than spending for many such drugs. The seapass growth exceeded that of such pure drugs.

After the impact of COVID-19 becomes less pronounced we expect a steeper prescription growth will accelerate.

In July we initiated our first direct to consumer promotion oversea, but for cardiovascular risk reduction in the United States.

The goal of this promotion is to increase awareness of the SEPA, Andrew encouraged at risk patients and health care professionals to enquire further about the SEPA.

While the impact of any such promotion is typically not immediate.

We believe it is important and it will help because recent survey data suggests that just 32% the positions and less than 1% of at risk patients were aware of a steep but as a proven therapy for cardiovascular risk reduction.

John Thurow: The SEPA growth during the third quarter and year to date continued to outpace the growth rates for more established drugs with positive cardiovascular outcomes data, such as statins. Moreover, placebo's growth in these periods also outpaced the growth of nearly all branded drugs for which positive cardiovascular outcomes results were reported within the past four years, while Vasepa does not compete against these other drugs. We are proud that in these challenging COVID-19 times and despite commercial spending to promote Fazepa being lower than spending for many such drugs, Fazepa's growth exceeded that of such peer drugs. After the impact of COVID-19 becomes less pronounced, we expect that Zika prescription growth will accelerate.

This is not surprising as the seat belt was only launch for this new indication in January 2020.

And various ever promotion and Education addition, Roche had been hindered by COVID-19.

We believe the potential for even greater growth justify our continued investment in expanded promotion purposes, but despite expectations for future generic competition.

Which leads me to comments regarding potential competition for generics companies.

As you know we are very disappointed that the federal circuit upheld the district court's earlier patent decision.

On November 4th 2020, our rehearing bunk petitions were denied.

John Thurow: In July, we initiated our first direct-to-consumer promotion of Vasepa for cardiovascular risk reduction in the United States. The goal of this promotion is to increase awareness of VASIPA and to encourage at-risk patients and healthcare professionals to inquire further about VASIPA. However, the impact of any such promotion is typically not immediate.

We plan within 90 days it was such denial, yes, the U.S. Supreme Court to hear our appeal.

We believe the courts for wrong in their decisions and we will continue to pursue this matter.

Although we cannot provide any guarantee of success in this pursuit.

Unfortunately, the decisions were not only wrong for the reasons, we articulated in our litigation.

Well there you also have the effect of harming patient care in the United States as fewer patients may ultimately benefit from placebo.

John Thurow: We believe it is important and it will help because recent survey data suggest that just 32% of physicians and less than 1% of at-risk patients were aware of Vasepa as a proven therapy for cardiovascular risk reduction. This is not surprising as Visepa was only launched for this new indication in January 2020, and various of our promotion and education initiatives have been hindered by COVID-19. We believe the potential for even greater growth justifies our continued investment in expanded promotion for Visepa despite expectations for future generic competition, which leads me to comments regarding potential competition from generic companies. As you know, we are very disappointed that the Federal Circuit upheld the District Court's earlier patent decision. On November 4, 2020, our rehearing and en banc petitions were denied. We plan within 90 days of such a denial to ask the U.S. Supreme Court to hear our appeal. We believe the courts were wrong in their decisions, and we will continue to pursue this matter, although we cannot provide any guarantee of success in this pursuit. Unfortunately, the decisions were not only wrong for the reasons we articulated in our litigation.

As a reminder, the patent law service he pays only in the United States and relate only to the niche the sheep indication approved in Twentytwo triglyceride lowering in patients with severely high triglyceride levels.

Which is defined by the FDA approved label and by medical guidelines as triglyceride levels greater than or equal to 500 milligrams per deciliter.

Importantly, such patents are not related to perceived as more recently approved indication for cardiovascular risk reduction.

For which over 90% of the SEPA prescriptions in the United States are written.

Typically even when generics companies have so called skinny labels.

Meaning labels that in one way or another communicate less than a brand's full label.

Graham companies typically experienced a more complete loss of sales.

We thank the many investors who sent us constructive suggestions on our legal options.

No that we have been tracking the GSK burst Teva case for some time.

The legal team representing GSK, a trial and on appeals.

Spansion overlaps with the legal team that represented Amarin before the federal circuit.

And the attorneys that submitted a brief for pharma on appeal and GSK versus <unk>.

John Thurow: But they also have the effect of harming patient care in the United States as fewer patients may ultimately benefit from Bicepa. As a reminder, the patent loss for Vasepa is only in the United States and relates only to the niche indication for Vasepa approved in 2012, triglyceride lowering in patients with severely high triglyceride levels, which is defined by the FDA-approved label and by medical guidelines as triglyceride levels greater than or equal to 500 milligrams per deciliter. Importantly, such patents are not related to FACEPA's more recently approved indication for cardiovascular risk reduction, for which over 90% of VACIPA prescriptions in the United States are written. Typically, even when generic companies have so-called skinny labels, meaning labels that in one way or another communicate less than a brand's full label. Brand companies typically experience a more complete loss of sales.

Represented us that trial and on appeal.

We do not intend during this call to get into further detail regarding our legal strategy or transportation's of case law in this area.

Doing so could be counterproductive to our interests.

As in the past, we refer you to our current and future disclosures in our 10-Q two.

The court filings into the frequently asked questions section of our corporate website, which we plan to continue to update periodically as events develop at amarin.

Typically generic products enter markets, where branded products have been voted for a decade or longer.

And such products are well understood by the applicable medical and patient communities.

The cardiovascular risk reduction indication for the Super was launched in January 2020.

We have only begun educational and promotional initiatives started to see both with respect to this broader and very important indication.

Undoubtedly yeah.

Amarin ceasing initiatives to educate and promote placebo for cardiovascular risk reduction is not in the best interest of patient care as generics companies are not anticipated to replace such initiatives with broad public education or promotion with.

John Thurow: We thank the many investors who sent us constructive suggestions on our legal options. You know that we have been tracking the GSK v. Teva case for some time. The legal team representing GSK at trial and on appeals substantially overlaps with the legal team that represented Amarin before the Federal Circuit, and the attorneys that submitted a brief for PhRMA on appeal in GSK v. Teva represented us at trial and on appeal. We do not intend during this call to get into further detail regarding our legal strategy or interpretations of case law in this area, as doing so could be counterproductive to our interests.

Without significant public educational and promotional initiatives, many health care professionals in at risk patients should learn about as deep as proven effectiveness may never do so.

In such a scenario the significant reduction in heart attacks strokes and cardiovascular death.

She served in the reduce it study may never be realized by the large number of patients at risk for such events.

We believe that increased promotion and education on the cardiovascular risk reduction indication will build market share for branded but she but even with generics in the market for the narrower label of triglyceride lowering.

John Thurow: As in the past, we refer you to our current and future disclosures in our 10Q, to court filings, and to the Frequently Asked Questions section of our corporate website, which we plan to continue to update periodically as events develop at Amarin. Typically, generic products enter markets where branded products have been promoted for a decade or longer, and such products are well understood by the applicable medical and patient communities. The Cardiovascular Risk Reduction Indication for Vasepa was launched in January of 2020, and we have only begun educational and promotional initiatives for BCIPA with respect to this broader and very important indication. Undoubtedly,

While amarins continued educational and promotional initiatives in the United States are clearly best for patient care.

We also believe that such initiatives are best for Amarin shareholders.

Together with our advisors, we ever conducted extensive analysis of the potential value too enamored of continuing initiatives to expand the use of the steep in the United States compared to launching our own generic version of the seed book.

The results of this analysis overwhelmingly continually.

Continuing our educational and promotional initiatives of the seatbelt to grow with the market.

John Thurow: Amarin ceasing initiatives to educate and promote Visepa for cardiovascular risk reduction is not in the best interest of patient care, as generic companies are not anticipated to replace such initiatives with broad public education or promotion. Without significant public educational and promotional initiatives, many health care professionals and at-risk patients who should learn about BASIPA's proven effectiveness may never do so. In such a scenario, the significant reduction in heart attacks, strokes, and cardiovascular death achieved in the REDUCE-IT study may never be realized by the large number of patients at risk for such events. We believe that increased promotion and education on the cardiovascular risk reduction indication will build market share for branded Visepa, even with generics in the market for the narrower label of triglyceride lowering.

Unless our assumptions changed significantly.

We intend to continue with all such forms of initiatives, including direct sales and direct to consumer promotion.

We are aware that we will likely lose some portion of policy prescriptions in the United States to generic versions of the steep.

But we're confident that with continued promotion we can build the market.

The need for us to see it but in the United States is large and we aim to grow with the market faster than generics companies can take meaningful market share due.

Due to anticipated generic manufacturing capacity limitations and associated time and cost for them to supply the market.

As we continue to grow the policy for brand the United States.

We're also advancing this important product in countries around the world, where we see a myriad of opportunities to benefit at risk patients while building. The proceed the franchise.

In Europe regulatory review by the European Medicines Agency continues to progress.

We look forward to proceed but becoming the first and only cardiovascular risk reduction therapy for patients with persistent cardiovascular risk.

John Thurow: While Amarin's continued educational and promotional initiatives in the United States are clearly best for patient care, we also believe that such initiatives are best for Amarin shareholders. Together with our advisors, we have conducted extensive analysis of the potential value to Amarin of continuing initiatives to expand the use of Visepa in the United States compared to launching our own generic version of Visepa. The results of this analysis overwhelmingly favor continuing our educational and promotional initiatives of the CEPA to grow the market. Unless our assumptions change significantly, we intend to continue with all such forms of initiatives, including direct sales and direct to consumer promotion.

We continue to expect approval of a steep up in Europe in early Twentytwenty one.

There was a large and growing opportunity for amarin to bring this potentially lifesaving therapy can millions of patients throughout Europe at high risk for cardiovascular events.

3.9 million Europeans die annually cardiovascular disease.

Representing approximately 45% of all deaths.

And over 49 million Europeans have cardiovascular disease.

A recent survey shows that about 25% of a representative sample of more than 7800 patients and 27 European countries with coronary heart disease uncontrolled LDL cholesterol levels had elevated triglyceride levels greater than 150 milligrams per deciliter.

John Thurow: We are aware that we will likely lose some portion of the SEPA prescriptions in the United States to generic versions of SEPA, but we're confident that with continued promotion, we can build the market. The need for Visepa in the United States is large, and we aim to grow the market faster than generous companies can take meaningful market share due to anticipated generic manufacturing capacity limitations and associated time and costs for them to supply the market. As we continue to grow the Visepa brand in the United States, we are also advancing this important product in countries around the world where we see a myriad of opportunities to benefit at-risk patients while building the Vizipa franchise In Europe, regulatory review by the European Medicines Agency continues to progress.

Illustrating the potential pervasiveness of high risk cardiovascular disease in Europe beyond currently available therapies.

For purposes of context, there are 44 million patients on Staten therapy in the European Union, including 32 million stand treated patients within the five largest markets of the European Union.

This compares to approximately 38 million stat treated patients in the United States.

As we have pointed out in the past not every state and treated patients is indicated for the SEPA. However, these data in patient numbers suggest that the size of the opportunity for us to keep up and Europe is comparable to the size of the opportunity in the United States.

This represents a multi billion dollar market opportunity for Vascepa in Europe.

As described previously our analysis reflects that self launching in Europe, rather than licensing a substantial portion of the upside to a third party company allows us to create the greatest value for amarin.

In doing so we will be leveraging our in depth knowledge of the science and clinical data without incurring a royalty cost for third party support in most countries.

John Thurow: We look forward to VACIPA becoming the first and only cardiovascular risk reduction therapy for patients with persistent cardiovascular risk. We continue to expect approval of SIPA in Europe in early 2021. There is a large and growing opportunity for Amarin to bring this potentially life-saving therapy to millions of patients throughout Europe at high risk for cardiovascular events. 3.9 million Europeans die annually of cardiovascular disease, representing approximately 45% of all deaths. And, over 49 million Europeans have cardiovascular disease. A recent survey showed that about 25% of a representative sample of more than 7,800 patients in 27 European countries with coronary heart disease and controlled LDL cholesterol levels had elevated triglyceride levels greater than 150 milligrams per deciliter, illustrating the potential pervasiveness of high-risk cardiovascular disease in Europe beyond currently available therapies.

Towards that end, we are making great strides in building our team and finalizing our go to market strategies.

In July we were delighted to welcome Green Mikael to the Amarin team to lead our commercial efforts in Europe.

Cream is making tremendous progress building off the work we have done over the past year to prepare for commercial launch in Europe.

He is actively recruiting and exceptional cross border team and preparing for medical access negotiations, which we plan to more formally begin on a country by country basis. After the CP was approved in Europe.

As you are aware there has been a research overnight change in Europe.

At this time, we do not anticipate COVID-19 to significantly delay the regulatory approval of the <unk> and Europe, while we are experiencing some headwinds from COVID-19.

In our commercial planning hiring and execution regarding commercialization Oversleeping Europe considerable progress is being accomplished.

Our commercial planning assumes that the impact to COVID-19 subside significantly by the time that they get through the reimbursement process. These in many countries.

We are assuming that digital promotion will need to be an important part of our promotional and educational initiatives for the SEPA in Europe.

John Thurow: For purposes of context, there are 44 million patients on statin therapy in the European Union, including 32 million statin-treated patients within the five largest markets of the European Union. This compares to approximately 38 million statin-treated patients in the United States. However, as we have pointed out in the past, not every statin-treated patient is indicated for Vasepa.

[laughter] launching of the C., but in Europe compared to launch in the United States purpose SEPA was launch for treating very high triglyceride levels well.

It will be for a much larger indication the cardiovascular risk reduction indication would.

We demonstrated outcomes trial results and no direct competition.

In addition launch in Europe will be aided by the fact that the SEPA is already indicated in the medical treatment guidelines of the European Society of Cardiology, Yes see.

John Thurow: However, these statin patient numbers suggest that the size of the opportunity for Vasepa in Europe is comparable to the size of the opportunity in the United States. This represents a multi-billion dollar market opportunity for Vasepa in Europe. As described previously, our analysis reflects that self-launching in Europe rather than licensing a substantial portion of the upside to a third-party company allows us to create the greatest value for Amarin. In doing so, we will be leveraging our in-depth knowledge of the science and clinical data without incurring royalty costs for third-party support in most countries. Towards that end, we are making great strides in building our team and finalizing our go-to-market strategy. In July, we were delighted to welcome Karine McHale to the Amarin team to lead our commercial efforts in Europe.

In the European Atherosclerosis Society, yes.

Notably in September 2020, the U.S.C. expanded their guidelines to also include patients with acute coronary syndrome.

As we launch the seep in each country in Europe, while we intend to do this in a stage manner aided by the timing of payer access we intend to do so robustly.

Our primary emphasis will be on educating specialists, particularly cardiologist about the SEPA. Although we also intend to target other specialists like endocrinologist and select general practitioners.

In Europe compared to the United States, a greater proportion of statin treated patients see cardiologist.

Which should create some relative efficiency in our promotion both because of the greater concentration of at risk patients and because cardiologist tend to be more data driven.

For example, in the United States Cardiologists have been the fastest group of physicians to increase the Super prescriptions. Following the positive results of the reduce it cardiovascular outcome study.

John Thurow: CREAM is making tremendous progress building off the work we have done over the past year to prepare for commercial launch in Europe. He is actively recruiting an exceptional cross-border team and preparing for medical access negotiations, which we plan to more formally begin on a country-by-country basis after PACEPA is approved in Europe. As you are aware, there has been a resurgence of COVID-19 in Europe.

I do not want to suggest that with approval of a steep in Europe that growth will be immediate.

As you are likely aware payer access in Europe needs to be negotiated on a country by country basis and this requires time.

Amarin currently is taking plenary steps to prepare for such access negotiations.

Until such access is secured in most countries of Europe, it would be futile to launch.

John Thurow: At this time, we do not anticipate COVID-19 to significantly delay the regulatory approval of CEPA in Europe. While we are experiencing some headwinds from COVID-19 in our commercial planning, hiring, and execution regarding the commercialization of Visepa in Europe. Considerable progress is being accomplished. Our commercial planning assumes that the impact of COVID-19 will subside significantly by the time that we get through the reimbursement processes in many countries. We assume that digital promotion will need to be an important part of our promotional and educational initiatives for VISIPA in Europe.

However, unlike in the United States, where when the SEPA was launched reimbursement needs to be built on a payer by payer basis in.

In most countries of Europe. Once the reimbursement is established positions do not have to worry about managed care surprises, which in the United States make some positions reluctance to prescribe new drugs.

We will comment further on our plans for Vascepa in Europe. After the drug is approved and we have further advanced our market access initiatives.

In parallel to our efforts to prepare for commercialization of the seep in Europe, Our medical Affairs and research and development teams continue to present compelling data.

Which is gaining attention of thought leaders throughout the world.

John Thurow: Launching Visepa in Europe, compared to launch in the United States, where Visepa was launched for treating very high triglycerides levels, will be for a much larger indication, the cardiovascular risk reduction indication, with demonstrated outcomes, trial results, and no direct competition. In addition, the launch in Europe will be aided by the fact that FACIPA is already indicated in the medical treatment guidelines of the European Society of Cardiology, ESC, and the European Atherosclerosis Society, EAS. Notably, in September 2020, the ESC expanded its guidelines to also include patients with acute coronary syndrome. As we launch FACIPA in each country in Europe, while we intend to do this in a staged manner gated by the timing of payer access, we intend to do so robustly. Our primary emphasis will be on educating specialists, particularly cardiologists, about the FIPA, although we also intend to target other specialists like endocrinologists and select general practitioners.

To discuss more of our progress in these areas I.

I now turn the discussion over to Dr., Craig Granowitz, our Chief Medical Officer.

Thank you John.

In support of the commercial launch preparations and Europe.

We are building a team of experienced medical affairs professionals and building relationships with key opinion leaders and with medical experts, who have extensive experience reimbursement agencies of key European markets.

As John noted lets people was recently added to the recommendation of the yeah and E. S. T for the treatment of high risk patients last year.

Notably in September Twentytwenty, yes, the expanded their guidelines also include patients with acute coronary syndrome.

Also notable in late October the endocrine society in the United States, which in the U.S. is the largest professional society representing issues important to the field of endocrinology.

Added, but cheaper to their guidelines say.

Operating EPS Super should be considered for first line therapy for people with elevated triglycerides and either Atlas karate cardiovascular disease or type two diabetes plus two additional risk factors.

John Thurow: In Europe, compared to the United States, a greater proportion of statin-treated patients see cardiologists, which should create some relative efficiency in our promotion both because of the greater concentration of at-risk patients and because cardiologists tend to be more data-driven. For example, in the United States, cardiologists have been the fastest group of physicians to increase Visepa prescriptions following the positive results of the reduced cardiovascular outcome study. I do not want to suggest that with the approval of a SIPA in Europe, growth will be immediate.

The Endocrinology society recommendation emphasize.

This cardiovascular disease benefit seen with the SEPA and a successful reduce it study does not apply to other omega three fatty acid, including those that are a mixture of EPA and DHL.

These guidelines and recommendations to the U.S.C. and the endocrine society increased at a double digit decline.

The number of medical societies worldwide, which have publicly affirmed the importance and recommended use of icons depend at opus cheaper to provide meaningful clinical benefit.

John Thurow: As you are likely aware, payer access in Europe needs to be negotiated on a country-by-country basis, and this requires time. Amarin is currently taking preliminary steps to prepare for such access negotiations. Until such access is secured, in most countries of Europe, it would be futile to launch.

And in advance of our plan you launch well more cardiovascular thought leaders have presented compelling data at the recent yes dee.

And he asked annual scientific sessions.

The full the superstore it continues to unfold.

As we learn more about how I caught that tend to not get it acts.

Dr. Craig Granowitz: However, unlike in the United States, where when Visepa was launched, reimbursement needed to be built on a payer-by-payer basis, in most countries of Europe, once reimbursement is established, physicians do not have to worry about managed care surprises, which in the United States makes some physicians reluctant to prescribe new drugs. We will comment further on our plans for Visepa in Europe after the drug is approved and we have further advanced our market access initiatives. In parallel to our efforts to prepare for the commercialization of Visepa in Europe, our medical affairs and research and development teams continue to present compelling data that is gaining the attention of thought leaders throughout the world. To discuss more of our progress in these areas, I now turn the discussion over to Dr. Craig Granowitz, our Chief Medical Officer. Thank you, John.

The cellular level.

In late August at the EPS seeds annual scientific sessions results were presented from the evaporate study.

Which showed the steeper demonstrated a significant.

17% regression of low attenuation black volume as measured by multi detector.

Computed.

Oh, mccargar fee when compared to placebo over 18 months.

Let's see if it is the first and only agent that has been studied in addition to Stepans reported to exhibit coronary plaque regression.

In hyper triglyceride eamich patients.

The final results of the Evaporate study showed a significant reduction in the primary endpoint.

<unk> <unk>, <unk> and Apple reduce lab volume by 17% from baseline to the 18 months scans, whereas that was an actual progression.

Lap volume in.

In the placebo group.

This study should be considered dealt within that context, the previous trials, which support this mechanism of action that could be associated with.

Dr. Craig Granowitz: In support of the commercial launch preparations in Europe, we are building a team of experienced medical affairs professionals and building relationships with key opinion leaders and with medical experts who have extensive experience with reimbursement agencies in key European markets. As John noted, CEPL was recently added to the recommendation of EAS and ESD for the treatment of high-risk patients last year. Notably, in September 2020, the ESC expanded their guidelines to also include patients with acute coronary syndrome. Also, in late October, the Endocrine Society in the United States, which in the U.S. is the largest professional society representing issues important to the field of endocrinology, added Visepa to their guidelines, stating that Visepa should be considered for first-line therapy for people with elevated triglycerides and either The Endocrine Society recommendation emphasizes that this cardiovascular disease benefit seen with SEPA in a successful reduced study does not apply to other omega-3 fatty acids, including those that are a mixture of EPA and DHA.

Cardiovascular risk reduction.

Throughout the year at various scientific meetings. We have also had the opportunity to further explore and present reduce it data showing the sheep effect in at risk patients in the clinical setting.

This includes presentations at various medical meetings.

For example, reduce it read that.

It was presented at the society for cardiovascular and geography, and interventions meeting showing first and total coronary revascularization event production.

34, and 36% respectively.

At the American Society for preventive cardiology.

Further analyses were presented showing early coronary revascularization benefit signal, but sustained statistical significance was attained as early as a 11 months after the initiation of treatment.

In the placebo group compared to placebo in the reduce it study.

In October at the Transcatheter cardiovascular Therapeutics connect 2020 meeting.

We were delighted to present, the reduce it PCR results, which demonstrated that the steep a significantly reduced scheme make events in patients with prior percutaneous coronary intervention or Pcr.

Dr. Craig Granowitz: These guidelines and recommendations of the ESC and the Endocrine Society increase to double-digits the number of medical societies worldwide which have publicly affirmed the importance and recommended use of icosapent ethyl vasepa to provide meaningful clinical benefits. And in advance of our planned EU launch, global cardiovascular thought leaders have presented compelling data at the recent ESC and EAS annual scientific sessions. The Fulvus Vipa story continues to unfold as we learn more about how icosapentaenoic acid acts at the cellular level.

The SEPA compared with placebo significantly reduce first and total major adverse cardiovascular events or mace in patients with a history of P.C.I. by 34 and 39% respectively.

Additionally, the key secondary endpoint was achieved.

In 30 over day reduction of 34%.

At the upcoming American Heart Association virtual scientific sessions there.

Reducing cabbage analyses will be presented providing even more insight into.

They have with you, but can potentially help patients avoid subsequent events that could have dire consequences regarding both health and cost.

Dr. Craig Granowitz: In late August at the ESC's Annual Scientific Session, results from the EVAPORATE study showed that FEPA demonstrated a significant 17% regression of low attenuation plaque volume as measured by multi-detector computed chromatography when compared to placebo over 18 months. FEPA is the first and only agent that has been studied, in addition to statins, reported to exhibit coronary plaque regression in hypertriglyceride The final results of the EVAPORATE study showed a significant reduction in the primary endpoint; Icosapent ethyl reduced lap volume by 17% from baseline to the 18-month scan, where there was an actual progression of lap volumes in the placebo group. This study should be considered, though, within the context of previous trials which support this mechanism of action that could be associated with cardiovascular risk reduction.

These findings in the P.T.I. setting are particularly relevant for payers because at a significant cost burden of revascularization events.

According to a 2014 report on the American Heart Association.

P.C.I. events in the U.S. and immediate inpatient hospital course cost of $84813.

In October.

The reduce it renal data.

Presented at the American Society of Nephrology kidney week meeting.

Showing that the consistency in benefit and safety of the SEPA administration across various at risk populations, including those with varying degrees of kidney dysfunction.

In addition at the end meeting real World evidence data was presented from.

<unk> database of U.S. veterans join.

Join that those veterans with decreased renal function and elevated triglycerides, alright, and increased risk, having a major adverse cardiovascular events.

Which supports the need.

[noise] elevated triglycerides as an independent marker of cardiovascular risk and even more so.

In those already high risk patients like those analyzed in the study.

Moving ahead, we look forward to the upcoming American Heart Association annual meeting session next week.

Dr. Craig Granowitz: Throughout the year at various scientific meetings, we have also had the opportunity to further explore and present reduced data showing placebo effects in at-risk patients in the clinical setting. This includes presentations at various medical meetings. For example, REDUCE-IT-REVASC was presented at the Society for Cardiovascular Angiography and Interventions meeting, showing first and total coronary revascularization event production of 34% and 36%, respectively, at the American Society for Preventive Cardiology. Further analyses were presented showing early coronary revascularization benefit signals with sustained statistical significance was attained as early as 11 months after the initiation of treatment in the placebo group compared to placebo in the reduced study in October at the Transcatheter Cardiovascular Therapeutics Connect 2020 meeting. We were delighted to present the reduced PCI results, which demonstrated that the CIPA significantly reduced. Schemic Events in Patients with Prior Percutaneous Foreign Intervention or PCI

Where they'll be eight clinical presentations that support the cardiovascular risk reduction benefits of the cheaper and that speaks to its underlying mechanism of action.

It's forum offers us an excellent opportunity to further educate cardiovascular specialist on.

On the clinical benefits of the steep but as a prime venue for further in the clinical and basic scientific understanding of icons depend up as cheap as you know.

Globally recognized medical and scientific form.

Let me now turn to a brief review of the work that we're supporting.

COVID-19 with the SEPA.

When the pandemic kit. It was suggested that the steep but may have an effect on inflammation caused when the COVID-19 bars attack the end easily which is a layer of sales lining blood vessels in the inner wall. So the heart chambers.

It was also suggested that certain of the seapass other mechanisms of action.

May be useful in treating cobot 90.

There is a scientific rationale for considering the steep but as having potential benefit minimized infection rates.

And or severity in non inspected but high risk patients.

The test this hypothesis Ameren supporting investigator run studies in two separate high risk groups.

The first being dosed with a history.

CBD.

Dr. Craig Granowitz: Placebo compared with placebo significantly reduced total major adverse cardiovascular events, or MACE, in patients with a history of PCI by 34% and 39%, respectively. Additionally, the key secondary endpoint was achieved in 30, a reduction of 34%. At the upcoming American Heart Association virtual scientific session, the reduced CABG analyses will be presented, providing even more insight into how the CEPA can potentially help patients avoid subsequent events that could have dire consequences regarding both health and cost. These findings in the PCI setting are particularly relevant for payers because of the significant cost of an ovary vascularization event. According to a 2014 report from the American Heart Association, PCI events in the U.S. had a median inpatient hospital course cost of $84,813.

And separately.

In groups of first line responders and health care workers were elevated potential risk of Kogan infection.

There's also a reason to believe that the steep a good independently reduce the severity of clinical of the clinical course of those are the active infection.

Additionally, there is a potential to consider but steep as an option.

And those with evidence of myocardial damage from a prior but cleared kogan infection.

Based on Amarins expertise and insights.

We are supporting the conduct of several pilot.

Investigators sponsored COVID-19 directed studies using the cheaper.

These ongoing studies are in the United States.

Canada and Argentina.

Some of these walk considered pilots are well more than a thousand patients each.

Our randomized blinded.

Or have matched control groups.

The goals of the studies are to generate data on the activity of the C. If any.

Dr. Craig Granowitz: In October, the REDUCE-IT renal data were presented at the American Society of Nephrology's Kidney Week meeting, showing the consistency in benefit and safety of SEPA administration across various at-risk populations, including those with varying degrees of kidney dysfunction. In addition, at the ACN meeting, real-world evidence data was presented from a database of U.S. veterans showing that those veterans with decreased renal function and elevated triglycerides are at an increased risk of having a major adverse cardiovascular event, which supports the need to look at elevated triglycerides as an independent marker of cardiovascular risk, and even more so in those already high-risk patients like those analyzed in the study.

On endpoints that relate to the progression and treatment of cobot infection.

Enrollment in each of these studies is progressing quite well.

We believe that enrollment progress.

Which includes relatively few patients opting not to try.

Reflects its already demonstrated positive safety and Tolerability profile.

It's important to note that we do not yet have data from any of these studies.

We look forward to the results of these studies sometime in 2021.

And hope that they will support the hypothesis as cheap as potential effects.

And this deadly virus and its clinical manifestation.

With that overview.

Let me turn it back to John.

Thank you Craig.

In addition to advancing our plans for the seep in Europe, we continue to make headway advancing our strategy to bring the steep but to a number of key geographies around the world.

Dr. Craig Granowitz: Moving ahead, we look forward to the upcoming American Heart Association's annual meeting sessions next week, where there will be eight clinical presentations that support the cardiovascular risk reduction benefits of SEPA and that speak to its underlying mechanism of action. This forum offers us an excellent opportunity to further educate cardiovascular specialists on the Clinical Benefits of SEPA and is a prime venue for furthering the clinical and basic scientific understanding of icosapent ethyl vasepa in a globally recognized medical and scientific journal. Let me now turn to a brief review of the work that we are supporting in COVID-19 with the SIPA. When the pandemic hit, it was suggested that Zika may have an effect on inflammation caused when the COVID-19 virus attacks the endothelium, which is a layer of cells lining blood vessels in the inner walls of the heart chamber.

By year end, we anticipate the topline clinical results from the triglyceride reduction study of a c., but conducted by adding farm our partner in China.

Assuming positive results, we intend to support our partner in rapidly pursuing approval, obviously, but in China.

In Canada, our partner HLS Therapeutics launched to seep in February.

In July they announced early success in achieving it Canadian agency for drugs and technologies in health recommendation for reimbursement of the SEPA.

By participating public drug plans for stat, untreated patients with established cardiovascular disease and elevated triglycerides.

In addition.

The introductory price submission by HLS did not trigger an excessive pricing investigation.

[noise] importantly, based upon these achievements.

Dr. Craig Granowitz: It was also suggested that certain of the SIPA's other mechanisms of action may be useful in treating COVID-19. There is a scientific rationale for considering Zuccipa as having potential benefit to minimize infection rates and or severity in non-infected but high-risk patients. In Tesla's hypothesis, Amarin is supporting investigator-run studies in two separate high-risk groups. The first being those with a history of CVD, and separately, in groups of first-line responders and healthcare workers who are at elevated potential risk of COVID infection. There is also reason to believe that Bifida could independently reduce the severity of the clinical course of those with active infection.

HLS highlighted their belief in the long term sales potential opus heap in Canada.

And reaffirmed their peak sales forecast of based in Canadian dollars 200 million to 300 million, noting that there could be potential upside to those figures.

We continue to work closely with HLS and are looking forward to continued progress with their ongoing launch in Canada.

Hopefully by building on the strong clinical efficacy demonstrated by the steep up we will have similar market access success in Europe, China and other parts of the world.

With that overview of the business, let me turn the call over to Mike Cobb, our CFO for more detailed discussion financials Mike.

Thanks, John for the first nine months of 2020 Amarin achieved significant growth in total net revenue. Despite the continued global impact created by the COVID-19 pandemic.

Dr. Craig Granowitz: Additionally, there is the potential to consider Visepa as an option in those with evidence of myocardial damage from a prior but cleared COVID. Based on Amarin's expertise and insights, we are supporting the conduct of several pilots. Investigator-sponsored COVID-19-directed studies using BASIP. These ongoing studies are in the United States, Canada, and Argentina.

When rates total revenue of $156.5 million and $446.8 million for the three and nine months ended September Thirtyth 2020, respectively, representing 39% to 56% increase just pets corresponding periods in 2019.

Dr. Craig Granowitz: Some of these well-considered pilots are well more than 1,000 patients each, are randomized, blinded, or have a matched control group. The goals of these studies are to generate data on the activity of Zika, if any, on endpoints that relate to the progression and treatment of COVID infection. Enrollment in each of these studies is progressing quite well. We believe that enrollment progress, which includes relatively few patients opting not to try, reflects its already demonstrated positive safety and tolerability profile. It's important to note that we do not yet have data from any of these studies. We look forward to the results of these studies sometime in 2021 and hope that they will support the hypothesis of CIPA's potential effect on this deadly virus and its clinical manifestation. With that overview, let me turn it back to John.

During the third quarter of 2020, we reported net product revenue of $155.2 million is 38% increase compared with the third quarter of 2019, and we achieved $441.1 million in net product revenue for the first nine months of 2020 reps.

Representing a 55% increase compared with the same period of 2019.

These increases were largely driven by increased U.S. received to sales which include a modest increase in visteon, because U.S. net selling price for emphasis the net selling price impact in the third quarter of 2020 over the same period of 2019 were small and due to annual donut hole issues with certain.

Payer coverage and.

As has been the pattern in prior years, the net price of a c., but in the third quarter of 2020 was modestly below average net price in the first two quarters of 2020.

John Thurow: Thank you, Craig. In addition to advancing our plans for Visepa in Europe, we continue to make headway with our strategy to bring Visepa to a number of key geographies around the world. By year-end, we anticipate the top-line clinical results from the triglyceride reduction study of a SEPA conducted by Edding Farm, our partner in China. Assuming positive results, we intend to support our partner in rapidly pursuing approval of VACIPA in China. In Canada, our partner HLS Therapeutics launched a SIPA in February. In July, they announced early success in achieving the Canadian Agency for Drugs and Technologies and Health recommendation for reimbursement of the SEPA by participating public drug plans for statin-treated patients with established cardiovascular disease and elevated triglycerides. In addition, the introductory price submission by HLS did not trigger an excessive pricing investigation.

As a reminder, amarin recognizes product revenue in the United States based on sales to wholesalers and specialty pharmacy providers in the U.S. are collectively its distributors or its customers in accordance with generally accepted accounting principles.

And not based on prescription levels reported by Symphony health or I should.

Average gross margin on net product revenue was approximately 78% for the first nine months of the year.

The slight increase compared to the same period in 2019, that's driven by gross margin on U.S. product sales of 79%.

Which was partially offset by the gross margin on product sales to Amarins partners outside the U.S., where the majority of the revenue is recorded by the partners.

Although amarin has continued to make improvements in our gross margin as discussed in the past the Super gross margins are lower than many other branded drugs due to its affordable pricing and the high manufacturing cost of the SEPA to the complexity of manufacturing the active pharmaceutical ingredient or EPA.

John Thurow: Importantly, based upon these achievements, HLS highlighted their belief in the long-term sales potential of the SIPA in Canada and reaffirmed their peak sales forecast of, based on Canadian dollars, $200 million to $300 million, noting that there could be potential upside to those figures. We continue to work closely with HLS and are looking forward to continued progress with their ongoing launch in Canada. Hopefully, by building on the strong clinical efficacy demonstrated by Visepa, we will have similar market access success in Europe, China, and other parts of the world. With that overview of the business, let me turn the call over to Mike Cobb, our CFO, for a more detailed discussion of our financials. Thanks, John.

At the high quality standards, we and the FTC I have said from the SEPA.

[noise] Amarin is approaching its goal of eliminating all of its debt by the end of 2020.

Iran has a 9.5 million dollar liability under its royalty bearing instrument, which will be fully paid during the fourth quarter of 2020 and once the final payment is made the company will have no debt obligations.

As of September Thirtyth, 2020, Amarin had cash and liquid investments in excess of $600 million accounts receivable net of $147.3 million and inventory of $148.5 million we.

We believe we have adequate supply to support our likely scenarios for near term sales demand and we continue our commitments to purchase a supply to support our anticipated the super growth in the United States and globally.

Mike Cobb: For the first nine months of 2020, Amarin achieved significant growth in total net revenue despite the continued global impact created by the COVID-19 pandemic. We reached total revenue of $156.5 million and $446.8 million for the three and nine months ended September 30, 2020, respectively, representing 39% and 56% increases compared to corresponding periods in 2019. During the third quarter of 2020, we reported net product revenue of $155.2 million, a 38% increase compared with the third quarter of 2019, and we achieved $441.1 million in net product revenue for the first nine months of 2020, representing a 55% increase compared with the same period of 2019. These increases were largely driven by increased U.S. VISIPA sales, which included a modest increase in VISIPA's U.S. net selling price

We believe our current resources are sufficient to fund our projected operations, including our planned commercial launch of a c., but in Europe.

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

As we look to the balance of 2020 and beyond we continue to believe that even with generic entry in the United States market. There remains potential for us to build on our success in expanding branded the seed but in the United States for this important drugs, new indication or cardiovascular risk reduction.

And we continue to believe that there are significant opportunities to build the SEPA franchise in a number of key international markets, both on our own and through partners.

2020 has been a difficult year for everyone and while Amarin has had its share of challenges I continued to be inspired by the hard work dedication and on laughable enthusiasm of the Enlink team.

I am proud to work with this team have accomplished professionals and to share a common goal of bringing the CP to patients around the world in order to reduce cardiovascular risk.

With that operator, we are ready to open the call to questions.

Thank you at this time, we will conduct a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation to indicate your line is it actually in Q.

Price start to feel like could remove your question from the queue for participants using speak we quit mint and maybe necessary to pick up your handset before pricing just starkey one moment, while we pull for our first question.

Mike Cobb: For emphasis, the net selling price impact in the third quarter of 2020 over the same period of 2019 was small, and due to annual donut hole issues with certain payer coverage, and as has been the pattern in prior years, the net price of a SIPA in the third quarter of 2020 was modestly below its net price in the first two quarters of 2020. As a reminder, Amarin recognizes product revenue in the United States based on sales to wholesalers and specialty pharmacy providers in the U.S. or collectively, its distributors, or its customers in accordance with generally accepted accounting principles, and not based on prescription levels reported by Symphony Health or IQ. Amarin's gross margin on net product revenue was approximately 78% for the first nine months of the year.

Our first question comes from Ami Fadia with SVB Leerink. Please proceed with your question.

Hi, Good morning. This is Ethan Entre army. Thanks for taking our questions two if I can.

Yes. So you know first leaving Hecla, you know indicated today, they're launching a generic so I wanted to get your thoughts more broadly on.

Cash management as any sort.

Sort of your thoughts on that as generic market and maybe what degree of generic impacts could result in a change in your promotional strategy.

In a sort of building off of this.

We see that take less generic came in at I think it's 9% black discount obviously, we know that your net price is much higher than that but.

You know.

Sure you know just curious how you think about ability and willingness to maintain meaningful market share in the U.S. should we think of that more as to eliminate generic supply.

Or from Amarin sort of willingness to compete with generics on price. Thank.

Mike Cobb: This slight increase compared to the same period in 2019 is driven by gross margin on U.S. product sales of 79 percent, which is partially offset by gross margin on product sales to Amarin's partners outside the U.S. where the majority of the revenue is recorded by the partner. Although Amarin has continued to make improvements in our gross margin, as discussed in the past, Visepa gross margins are lower than many other branded drugs due to its affordable pricing and the high manufacturing cost of Visepa due to the complexity of manufacturing the active pharmaceutical ingredient, or EPA, at the high quality standards we and FDA have set for Visepa. Amarin is approaching its goal of eliminating all of its debt by the end of 2020. Amarin has a $9.5 million liability under its royalty-bearing instrument, which will be fully paid during the fourth quarter of 2020, and once the final payment is made, the company will have no debt obligation. As of September 30, 2020, Amarin had cash and liquid investments in excess of $600 million, accounts receivable net of $147.3 million, and inventory of $148.5 million.

Thank you.

Hey, even though this is John thanks for the question, yes. So as you have cited a generic my has published there.

Whack price for their generic product, which is about 8.9% lower than our WACC price, which would be oh.

A price that is you know got to be more expenses for many payers than what.

<unk> is available to them on a a.

Net basis, but you know as you know the decisions often for what drug is dispensed is made at the retail pharmacy not the.

Not the payer, although based upon that pricing I wouldn't anticipate that the generics would get preferential treatment.

By the payers. So it is our understanding and this includes a you know based upon public comments made from the generics companies.

That they have limited supply. It's also our view that the market opportunity for us to see but in the United States is very large the as stated during our prepared comments.

Most patients most physicians don't yet know about the CE Pro this is very early in the life Oh, let's see before generic to be introduced to the market. It is our view that because of that substantial upside.

Mike Cobb: We believe we have adequate supply to support our likely scenarios for near-term sales demand, and we continue our commitments to purchase supply to support our anticipated VSEPA growth in the United States and globally. We believe our current resources are sufficient to fund our projected operations, including our planned commercial launch of Visepa in Europe. With that financial overview, I will now turn the call back to John for closing remarks.

And because of the tremendous cost and time associated with building supply capacity something that we've been working earnestly on for over a decade, you know that we can in the United States.

Grow our revenues faster than the generics can supply the market and it's our intention to do so well certainly for wrong in that we don't think we are but we were wrong in that so we could compete with our own generic and moved to that very quickly, but right now our view is a firmly.

John Thurow: As we look to the balance of 2020 and beyond, we continue to believe that even with generic entry into the United States market, there remains potential for us to build on our success in expanding branded vasepa in the United States for this important drug's new indication of cardiovascular risk reduction. And we continue to believe that there are significant opportunities to build the BASIPA franchise in a number of key international markets, both on our own and through partners. 2020 has been a difficult year for everyone.

But there's much more value under the curve by growing revenues and taking a substantial piece of that growth. You'll then there is by going and trying to compete on on on price and or trying to compete as a.

As a authorized generic so.

Our strategy that we articulated in the call today was in anticipation of generic launch a there maybe others are those launches are for the U.S. only when those launches are for the initial indication of placebo for triglyceride lowering in patients with very high.

Operator: And while Amarin has had its share of challenges, I continue to be inspired by the hard work, dedication, and unflappable enthusiasm of the Amarin team. I am proud to work with this team of accomplished professionals and to share a common goal of bringing Visepa to patients around the world in order to reduce cardiovascular risk. With that, Operator, we are ready to open the call to questions. Thank you.

You know triglycerides, and we will continue to pursue.

Pursue aggressively the growth of the market.

While also considering or whatever legal options. So remain hopefully those comments are helpful.

Great. Thank you.

Our next question comes from Louise Chen with Cantor Fitzgerald. Please proceed.

Hi, Thanks for taking my questions. So first question I had was how.

Should we think about broadly topline basis 2021 sales grows and opex in light of several moving parts. The pandemic potential generic competition, you expansion and expansion into other geographies and the second question I had for you was there is there any update you can give on the China opportunity market size. What are your economics are there.

Operator: At this time, we will conduct a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

How should we think about that versus U.S. and you opportunities. Thank you.

Okay.

We're a lose lose good morning with regard to 2021, you know that's a that's a difficult one.

Operator: One moment while we pull for our first question. Our first question comes from Ami Faria with SBB Lyric. Please proceed with your question. Hi, good morning. This is Issan Antarami. Thanks for taking our question. Maybe two, if I can.

Yes.

Very difficult to predict you know where coal is going to go to <unk>.

[noise] gene as an effective isn't as effective.

You know we saw significant improvement.

Ami Faria: Yeah, so, you know, first, I think Hikma, you know, indicated today they're launching their generics. So, you know, I wanted to get your thoughts more broadly, sort of your thoughts on that as generics enter the market and maybe what degree of generic impact they will have. And maybe sort of building off of this.

So she is always our offices to our sales reps during the third quarter versus the second quarter, but you know still roughly half of them half. The doctors don't allow face to face direct sales calls yet that's but again much better than it was in the second quarter did you see many fewer patients you know going to.

Ami Faria: You know, we see that Hickman's Generic came in at, I think it's a 9% WAC discount. Obviously, we know that your net price is much higher than this, but, I'm just curious how you think about the ability and willingness to maintain meaningful market share. Should we think of this, you know, more as an Unlimited Shared Supply or from Amarin's sort of willingness to compete with you? Hey, Ethan. Hey, this is John.

Doctors for preventative care, you know then it sort of pre cobot, but again that was better in the third quarter than in the second quarter.

[noise] how much this covert you'll have a <unk> a second wave here when does it get.

Radical <unk>, if ever or what the effectiveness of vaccines are you know, it's our view right or wrong that by the middle of the coming year.

The.

The world relative to patient access to physicians and our sales force is accessible positions will be somewhat back to normal probably never quite exactly the same but somewhat normal weather that hypothesis turns out to be true I think is unchartered territory, but we think things will continue to improve albeit a.

John Thurow: Thanks for the question. Yes, as you have cited, Ecoma has published their WAC price for their generic product, which is about 8.9% lower than our WAC price, which would be a price that is, you know, got to be more expensive for many payers than what companies are offering because they have a limited supply. It is also our view that the market opportunity for Vasipa in the United States is very large, as cited during our prepared comments. Most patients and most physicians don't yet know about FAACIPA.

Oh, so volatility and you guys are we betting on that we are continuing forward with our promotion both through our direct sales force and through various forms of electronic and TV based a promotion to educate physicians and patients about.

John Thurow: This is very early in the life of FACIPA for a generic to be introduced to the market. It is our view that because of that substantial upside. And because of the tremendous cost and time associated with building supply capacity, something that we've been working earnestly on for over a decade, you know, that we can in the United States, Roanna Ruiz, Georgi Yordanov, Thomas Reilly, Steven Ketchum, Amarin Corporation Plc Sponsored ADR, Until then, there is bye, going and trying to compete on on price and or trying to compete as a as a authorized generic so, Our strategy that we articulated in the call today was in anticipation of generic launch. There may be others.

Let's see but I cited during the call the.

The knowledge out there, particularly on the aided awareness or placebo for cardiovascular risk reduction is very low which is.

Huge opportunity but.

Can't at this point in time quantify what our revenue. So yeah, we'll be going forward I also can't quantify specifically the.

The level of generic supply that will be double wall based upon the information that's available to us we believe that that's a blog while meaningful.

He is.

And that we believe we can outgrow the.

Visibility of such supply that's something that we'll need to continue to.

Monitor or relative to Europe, we will have more information to provide regarding Europe. After we get label approval, which we anticipate in the early part of the coming year as we've articulated the launch in Europe is likely to be on a phased basis as we can get.

John Thurow: Those launches are for the, in the U.S. only, when those launches are for the initial indication of Zika-4 triglyceride lowering in patients with very high triglycerides. And we will continue to pursue aggressively the growth of the market while also considering whatever legal options remain. Hopefully, those comments are helpful.

You know reimbursement on a country by country basis will seek to launch lunch.

Robustly in each country, but that is a phased process China is a big opportunity for us. So I believe in our website, we ever frequently as well.

Louise Alesandra Chen: Our next question comes from Louise Chen with Canterfish General. Please proceed. Hi, thanks for taking my question. The first question I had was, how should we think about, broadly, top line basis 2021 sales growth and OPEX in light of several moving parts, the pandemic, potential generic competition, EU expansion, and expansion into other geographies? And the second question I had for you was, is there any update you can give on the Chinese opportunity market size, what your economics are there, and how should we think about that versus US and EU opportunities? Good morning.

Question and in our 10-Q or 10-K, we've got some discussion relative to the economics with our.

With our partner there we do provide we will once they are approved and selling the product.

The cell.

Selling that product to them on a call.

Cost plus basis, we will.

Double digit.

Royalties from them as a reminder, the trial that they have conducted a in China is a trial for treatment of patients with triglyceride levels that are very high similar to our marine study, although with more patients in that study prior to commencing that study or partner did speak with trying to FDA.

John Thurow: With regard to 2021, you know, that's a difficult one. Very difficult to predict where COVID is going to go. Is it effective? Isn't it effective?

About what would be needed to bridge the data for the SEPA too the other clinical trials done globally with busy but you know such as reduced it which was ongoing at that point in time and after we have <unk>.

John Thurow: You know, we saw a significant improvement. We sent offices to our sales reps during the third quarter versus the second quarter, but still roughly half of them, half of the doctors don't allow face-to-face direct sales calls yet. That's, again, much better than it was in the second quarter.

As a result from that trial and Eddingpharm is able to speak with China FDA Oh, we are hopeful that there will be a path forward to <unk>.

John Thurow: We continue to see many fewer patients going to doctors for preventative care than they did sort of pre-COVID, but again, that was better in the third quarter than in the second. How much of a. How much does COVID, you know, have a... A second wave here? When does it get?

Getting labeling in China, you know that would be broader than triglyceride lowering in which could potentially reference the cardiovascular risk reduction opportunity. There we know that some medical societies and China are considering as have now you know more than.

John Thurow: Radicated, if ever, what the effectiveness of vaccines is, you know, it's our view, right or wrong, that by the middle of the coming year, there will be volatility. And, you know, as we're betting on that, we are using electronic and TV-based promotion to educate physicians and patients about placebo as cited during the call. The knowledge out there, particularly unaided awareness of VISIPA for cardiovascular risk reduction, is very low, which is a huge opportunity.

No more than 10.

Bill Medical societies recommended use of Iqos spin up we'll see before cardiovascular risk reduction, we're hoping that the medical studies in China will follow that as well, but without yet having the data presented and without yet having had those discussions with trying to have <unk> relative to the label its a premature.

To be able to tell you, it's because more specifics relative to the market size other than the fact that cardiovascular disease is clearly growing in China and our partner there is quite excited so which I had more details for you, but that's where we are today.

John Thurow: I can't, at this point in time, quantify what our revenue... I also can't quantify specifically the level of generic supply. Global.

Thank you.

Our next question comes from Yasmeen Rami with Piper Sandler. Please proceed with your question.

John Thurow: Wow, on the information that's available to us. We believe that that supply, while meaningful, and that we believe we can outgrow the availability of such supply, that's something that we'll need to continue to monitor. Relative to Europe, we will have more information to provide regarding Europe after we get label approval, which we will participate in the early part of the coming year as we've articulated the launch in Europe is likely to be on a Transcripts provided by Transcription Outsourcing, LLC, selling that product to them on a cost plus basis. We will, uh..., and Double-Digit Royalties from them.

Hi team congrats on the continued progress that you're making given the challenging times.

Hmm. So two quick questions for you. The first one is can you comment on just generally we get this question constantly from Investor day, how many high quality suppliers are there in the world what percentage of them have you secured and how long it sort of your supply chain secured four and then.

The second question is you know the cobot studies, but do you have ongoing they're quite large prepare its 1500 patient mitigate is 16500 patients can you comment on what you hope to see on those and those studies and and to go for what the next steps be a need in the utility of that data and then.

John Thurow: As a reminder, the trial that they have conducted in China is a trial for the treatment of patients with triglyceride levels that are very high, similar to our marine study, although with more patients in that study. Prior to commencing that study, our partner spoke with the Chinese FDA about what would be needed to bridge the data for the ZIPA to the other clinical trials done globally with the ZIPA, such as REDUCE-IT, which was ongoing at that point in time. And after we have...

Okay for taking my question.

Oh, Yeah, I mean, the thanks for the comments and appreciate that relative to supply you know when we started in this area. They were you know, which again this goes back more than a decade, you know there were at that point in time.

Dozens of companies that you know go up that they could put.

John Thurow: The results from that trial, and Edding Farm is able to speak with the Chinese FDA. We are hopeful that there will be a path forward to..., getting labeling in China, you know, that would be broader than triglyceride lowering, in which we could potentially reference the cardiovascular risk reduction opportunity there. We know that medical societies in China are considering, as we have now, more than growing in China, and our partner there is quite excited. So I wish I had more details for you, but that's where we are today. Our next question comes from Yasmin Rami with Piper Sandler. Please answer the question.

[laughter] could produce the super <unk> to the quality standards that we want it up and you know we began working with some of them and have those.

Those capacity so over the years some of them started off as you know manufacturers of.

Of Ah you know product for dietary supplements and we need to help them become qualified.

Manufacturers of Apiay for pharmaceutical surgical grade.

Some were manufacturers of other <unk> eyes, but in all cases, it required in hand, holding by Amarins from a technical perspective, ER and indoor investment from <unk> M. ring.

Yasmin Rami: Hi team, congratulations on the continued progress that you're making given these challenging times. So two quick questions for you. The first one is, can you comment just generally, we get this question constantly from investors: how many high-quality suppliers are there in the world? What percentage of them have you secured?

And you know we have you know been continuing to grow that supply chain you know at this point in time, we are using.

[laughter], we are buying because we need it you know all the product that those suppliers can.

John Thurow: And how long is your supply chain secured for? And then the second question is, you know, the COVID studies that you have ongoing are quite large; PREPARE is 1,500 patients, Mitigate is 16,500 patients. Can you comment on what you hope to see in those studies and, to move forward, what would the next steps be in the utility of that data? And thank you again for taking my question. Thanks for the comments and suggestions.

Produce and as we get ready for Europe and China.

So our view that we're going to need more supply than what we're currently getting from a those.

Welcome to the suppliers about potential Oh, you know growth you know beyond that and we're certainly hopeful that they appreciate the upside opportunity.

That that we.

Present, we are assuming that the generic companies are looking out there and saying that there are dozens of companies that produce.

John Thurow: I appreciate that. Relative to supply, when we started in this area, which goes back more than a decade, there were, at that point in time, dozens of companies that, you know, thought that they... [inaudible] Product for Dietary Supplements, and we need to help them become qualified, API for pharmaceutical grade. Some were manufacturers of other APIs, but in all cases, it required hand-holding by Amarin from a technical perspective and or investment from Amarin. And, you know, we have been continuing to grow that supply chain. At this point in time, we are using, you know, multiple APIs. We are buying because we need all of the product that those suppliers can produce, and as we get ready for Europe and China, it's our view that we're going to need more supply than what we're currently getting from those suppliers. We talk to those suppliers about potential growth beyond that, and we're certainly hopeful that they appreciate the upside opportunity that we have.

John Thurow: We are assuming that the generic companies are looking out there and saying that there are dozens of companies that produce API or produce Omega-3 products, and you know they're probably going through some of the same decision-making processes that we were making. You know, over the last decade, how much do you invest in companies that have done Products for Dietary Supplements and try to make them qualified for API. For a pharmaceutical grade product, or do you try to take a product from companies that are used to doing pharmaceutical grade products and install the unique equipment needed for Visepa? It's expensive, you know; the lead time even for a product. Facility that's up and running, you know, is roughly six months to deliver product the lead time.

And we're very proud of our supply chain and right now we're continuing to try to grow that supply chain.

It doesn't prevent somebody else from doing the same thing, but doing the same thing requires a time and money and a lot of attention to detail and to quality. So you know, we'll see what happens there. We continue to we continue to monitor who who might.

Or might not be supplying.

Generics I think.

You know as you would probably expect various apiay suppliers are sometimes reluctant to deal with generic companies as a as you know they're not always the most reliable relative pricing into demand and because they tend to not grow markets and getting involved with somebody is not going to grow market.

Is he had some questions there, but those are really decisions for the for those suppliers to to consider.

John Thurow: Okay, Brownfield to a new plant that's in and qualified, you know, College and financial commitment. We're very proud of our supply. Right now, we're continuing to try to grow that supply chain. It doesn't prevent somebody else from doing the same thing, but doing the same thing requires time and money and a lot of attention to detail and to quality.

Relative to the Covance studies they are substantial you have <unk>.

What we do with that data it really depends upon what the results of the studies are we're seeing things obviously in the cobot area for other companies that.

Aren't complete data sets you know get lots of attention.

We think we ought to have some a data before we start raising our hands and saying Hey look at AOS.

John Thurow: We'll see what happens there. We continue to monitor who might or might not be supplying generics, I think. Unknown Executive, Paul Choi, Jordan Zwick, Amarin Corporation Plc Sponsored ADR, What we do with that data really depends upon what the results of the studies are. You know, we're seeing things obviously in the COVID area for other companies that, you know, aren't Please see the complete disclaimer at https://www.patreon.com, have the data, we will, you'll see whether there's Sponsored ADR, Mitigate the effects of COVID in patients who are already infected or whether it's to help to deal with the after effects of COVID, we'll have a better sense of that after, in 2021. We are, for the avoidance of doubt, entirely blinded to the results of the studies at the. Thank you, John. Our next question comes from Michael Yee with Jefferies. Please proceed with your question. Hey, John. Thanks. Good morning, and I appreciate all the work during these times.

We have the data we will you will see whether the path forward and whether that path forward is on helping.

Prevent patients from getting colder weather.

Okay.

Mitigate the effects of Covidien and patients who are already infected or whether it's to help to deal with the after effects of covert a we'll have a better sense of that ACTRIMS sales.

[noise] [noise] anticipate to be coming in the in that business and.

In 2021, we are just for going to doubt entirely blinded to the results of the studies at this point in time.

Thank you John.

Thanks. Our next question comes from Michael Yee with Jefferies. Please proceed with your question.

Hey, John Thanks, Good morning, and Dan I appreciate all the work during these times a two part question for you Hot first was shutdown as you can see there's a lot of questions around the dynamics and the generic but for investors, it's pretty hard to figure out what the next year, even looks like or next two years.

So maybe you could just put all these pieces together do you think that you could actually grow and 2021 or 2020 or yes, hone a substantial amount yes. The answer yes, yes.

Michael Yee: Two-part question for you. First, as you can see, there's a lot of questions around the dynamics of the generic, but for investors, it's pretty hard to figure out what the next year even looks like or the next two years. So maybe you could just put all these pieces together.

And Jack near year over year and beyond that's what we're that's what we're betting on though is obviously risks to that but based upon our view of the market opportunity which is substantial.

And based upon our both our experience with supply and knowledge.

John Thurow: Do you think that you could actually grow in 2021 over 2020 or maintain a substantial amount? Yes. The answer is yes. Yes. And beyond. That's what we're betting on.

In public comments from some of the some of the generic companies we believe that.

You can grow the market in the United States.

Faster than what they can do.

The market probably good for probably good for everybody.

Wow, Okay, and then secondly for I guess those two are not copper there may be some variability in that right. Mike. So yeah. You know the the you know I don't know how much you know supply has been built up by Hikma for example.

John Thurow: There's obviously risk to that, but based upon our view of the market opportunity, which is substantial, and based upon both our experience with supply and knowledge and public comments from some of the generic companies, we believe that we can grow the market in the United States, a market probably good for probably good for everybody. Okay. Um, and then secondly, for, I guess, those who are not confident, There may be some variability in that, right, Michael? So, uh, you know, the, the, you know, I don't know how much supply has been built up by HICMA, for example. And, you know, it's against that steady state that we think we can grow the market, you know, faster. COVID's a wild card. You saw what we did in the first quarter.

Yeah, I don't think it's huge but you know anytime you're putting product into the pipeline you know the the wholesalers will probably by initially you know whatever that product exists and that may take a.

Let me take a little bit of a bump on our sales to wholesalers, but ultimately.

On a steady state will be reduced and you know it's.

Against that steady state that we think we can grow the market you know faster now covered the wildcard in that mix, but you saw we did in the first quarter you know before coated and that was a new even before our full sales force to put into place before advertising was put into place. So.

We think we can get beyond covert there's so many patients out there who could potentially benefit we know how broad medical support reimbursement has improved really tremendously as we've moved here through 2020.

John Thurow: [inaudible] really tremendously as we've moved here through 2020 and as we go into 2021. So all those factors lead us to a view that, you know, we can grow prescriptions faster than what can be supplied by. If we're wrong, we can adjust. Right now, that's our. Okay, and then just to close that out, even if you go out farther than 2021 or 22, Loveza, Renagel, some of these other drugs, are those good examples for where you think you would sustain a substantial amount of your existing US revenues, even in the face of having some generics in the market? Do you think that that is the case?

<unk>.

As we go into 2021, so all those factors, we think leads us to a view that you know we can grow prescriptions faster than what can be supplied by.

For wrong, we can adjust but right now that's our view.

Okay, and then just to close that out even if you go farther than 2021 or 22 little.

Phase Irene in jail. Some of these other drugs are those good examples for where you think you would sustain his substantial amount of your existing U.S. revenues, even in the face of having some generics in the market do you think that that that is the case, 50% something like that.

John Thurow: 50%? Something like that? You know, in Japan, Mochida, which sells Epidel, which is an EPA-based product, you know, their product has been generic now for over a decade, and I believe the branded product still represents over 60% of the market share. The, Unknown Executive, Paul Choi, Jordan Zwick, Amarin Corporation Plc Sponsored ADR When generics were launched, essentially... Adopt All Promotion and All Focus on that product, whereas that was a much more mature product when Generics were launching. We just got approval. Launching in the first quarter of this year for cardiovascular, you know, risk reduction. It is somewhat strange, somewhat unusual for a generic to be introduced when the product is still not well known by the medical community of the patient community. So not sure that the way, and also the manufacturing of the SIPA is more difficult than that of LaVazza. Time will tell, but I think if you were to try to pick an example, the Machita example might be a better one.

You know in Japan, a moat cheetah would sales epidemic, which is a.

EPA based product you know their product has been generic now for over a decade and I believe the branded product still represents over 60% of the.

Of the market share.

The you know little days I don't know that such a great example, because you know GSK in the United States.

When generics relaunch essentially stay.

Topped all promotion in all focusing on that.

On that product you know, where as you know and that was a much more mature product when generics were launching we just got approval.

John Thurow: Okay, perfect. Thank you. I appreciate it. Thank you at this time. There are no further questions in queue, and we would like to thank you for joining the conference today. You may disconnect your lines at this time, and thank you for your participation. All right, I'm going to hang up this line.