Q4 2020 Amarin Corporation PLC Earnings Call

Welcome to Amarin Corporation's conference call to discuss its fourth quarter and full year 2020 financial results and operational updates.

Operator: Welcome to Amarin Corporation's conference call to discuss its fourth quarter and full year 2020 financial results and operational updates. This conference call is being recorded today, February 25th, 2021. I would like to turn the conference call over to Alina Dubrovna, Associate Manager of Investor Relations at Amazon. Thank you, operator.

This conference call is being recorded today February 25 2021.

I would like to turn the conference call over to Elina net barrels now associate manager of Investor Relations of Amarin.

Thank you operator, and thank you to everyone for joining our fourth quarter and full year 2020 results before we begin let me turn to our forward looking statements.

Unknown Executive: And thank you to everyone for joining us for our fourth quarter and full year 2020 results. Before we begin, let me turn to our forward-looking statements. 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 RSEPA prescriptions, RSEPA product and licensing revenue, costs, gross margin, and other commercial metrics; and our current plans and expectations regarding spending, including expenditures for the promotion of RSEPA and for purchases of additional supply of RSEPA. Our current expectations regarding the adequacy of our financial resources.

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 occur.

Our current expectations regarding our commercial and financial performance, including levels of Vascepa prescriptions.

Keep up product and licensing revenue cost gross margin and other commercial metrics of current plans and expectations regarding spending including expenditures for the promotion of Vascepa and for purchases of additional supply of the C.

Our current expectations regarding the adequacy of our financial resources.

Unknown Executive: Our current plans and expectations for product revenue growth, sales force productivity, and product promotion in light of COVID-19 and the potential for increasing 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 launch of generic versions of the SEPA by generic companies and by ourselves. Our current expectations for the substance and timing of the SEPA regulatory reviews outside of the United States.

Our current plans and expectations for product revenue growth.

As far as productivity and product promotion in light of COVID-19, and the potential for adding attention to of cardiovascular risk reduction drugs like the FIFA and the result of COVID-19, our current plans and expectations related to patent litigation and expectations related to the potential launch of generic versions of.

Vascepa of generic companies and by herself.

Our current expectations on the substance of timing of Vascepa regulatory reviews outside of the United States.

Unknown Executive: Our current plans and expectations regarding the timing, scope, and success of international expansion, including expectations regarding our ability to launch the SCEPA 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 SIPA exclusivity outside of the United States, including Europe and China. Our current plans for commercial expansion in the United States with the entry of current and potential future generic companies, and our current plans and expectations regarding the clinical study of SEPA related to COVID-19

The current plans and expectations regarding the timing scope and success of international expansion, including expectations regarding our ability to launch of Vascepa in Europe.

Our expectations in China for clinical trial, the adult and potential to reduce it results in labeling and promotion of as people kind of are.

Partner in China.

Our current plans and expectations regarding vascepa exclusivity outside of the United States, including Europe and China.

Our current plans for commercial expansion in the United States with the entry of current and potential future generic competition and our current plans of an expectation regarding the clinical study of Vascepa related to COVID-19.

These statements are based on information available to us today February 25th 2021.

Unknown Executive: These statements are based on information available to us today, February 25th, 2021. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations as disclosed in our forward-looking statements. Actual results and events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements if circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements we may enter into, amend, or terminate.

We're not actually achieve our goals carry out our plans or intentions or meet the expectations are disclosed in our forward looking statements.

Actual results and events could differ materially.

You should not place undue reliance on the statements we assume no obligation to update these statements of circumstances change our forward looking statements did not reflect the potential impact of significant transactions, we may enter into such as mergers acquisitions dispositions joint ventures or any material agree.

We may enter into a man of Germany.

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 31st 2020, which has been filed with the SEC and is available through the Investor Relations section of our website.

Unknown Executive: 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, 2020, which has been filed with the SEC and is available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read this document.

Ah Www Dot Amarin Corp, Dot com, we encourage everyone to read the document. This call is intended for investors in Amarin and is not intended to promote the use of vascepa outside of its approved indications.

Unknown Executive: This call is intended for investors in Amerin, and it is not intended to promote the use of a SIPA outside its approved indication. An archive of this call will be posted on Amarin's website within the Investor Relations section. Making prepared remarks on today's call will be John Farrell, President and Chief Executive Officer, and Michael Kalb, Chief Financial Officer. After their prepared remarks, we will open the call to your questions. I remind you that multiple audiences typically listen to calls of this nature, including existing investors, potential new investors, employees, current and potential collaborators, and current and potential competitors. As always, on this call, we will attempt to provide constructive information without compromising our competitive and strategic positioning. I now turn the call over to John Farrow, President and Chief Executive Officer of Amarin.

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

Making prepared remarks on today's call will be John <unk>, President and Chief Executive Officer, and Michael Kalb, Chief Financial Officer.

After prepared remarks, we will open the call to your questions I remind you the multiple audience is typically listen to calls of this nature, including existing investors potential new investors employees current and potential collaborators and current and potential competitors as always in this call we will appeal.

To provide constructive information without compromising our competitive and strategic positioning.

I'll now turn the call over to John <unk>, President and Chief Executive Officer of Amarin.

Hello, and thank you all for joining us this morning.

John Farrell: Hello, and thank you all for joining us this morning. Because we provided substantial comments last month on our expected 2020 results, and our annual report as filed today reflects confirmation and formalization of what has already been reported. We intend today to be relatively brief in our prepared comments. 2020 was a year of considerable progress for Amarin, with important achievements across multiple areas, including the launch in the United States of Bicepa for the Treatment of High-Risk Patients with Persistent Cardiovascular Risk, or PCVR. Creating the foundation of our European commercial organization. Progress by our international partners, and important scientific advancements, including demonstration of plaque regression through the administration of ACEPA in patients evaluated in the EVAPORATE study. That said,

Because we provided substantial comments last month on our expected 2020 results.

Our annual report is filed today.

Flex confirmation and formalization of what has already been reported.

We intend today to be relatively brief in our prepared comments.

2020 was a year of considerable progress for amarin.

With important achievements across multiple areas, including launch in the United States of Vascepa.

For the treatment of high risk patients with persistent cardiovascular risk or P. CVR.

Creating the foundation of our European commercial organization.

Progress by our international partners.

Important scientific advancement, including demonstration of plaque regression through administration of Vascepa in patients evaluated in the evaporate study.

That said.

John Farrell: 2020 was also a year we all faced great challenges with the COVID-19 global pandemic. Amarin specifically faced both the difficulties posed by the pandemic and the loss of our patent litigation in the United States for Visepa's original triglyceride-lowering indication. I am proud to say that the Amarin team rose above these obstacles with great determination and advanced the company across all areas of the business, including commercial, clinical, and corporate. Let me begin with our most visible achievement in 2020, our record level of revenue. We reported annual net total revenue of $614.1 million in 2020, an increase of 43% compared to 2019.

2020 was also a year, we all face great challenges with the COVID-19 global pandemic.

Amarin, specifically face both the difficulties posed by the pandemic and the loss of our patent litigation in the United States for Vascepa is original triglyceride lowering indication.

I am proud to say that the amarin team rose above these obstacles with great determination and advanced the company across all areas of the business.

<unk> commercial clinical and corporate.

Let me begin with our most visible achievement in 2020, our record level of revenue.

We reported annual net total revenue of $614 $1 million in 2020, an increase of 43% compared to 2019.

Both of our full year revenue in our fourth quarter 2020, net revenue, which was $167 $3 million or record levels for amarin.

John Farrell: Both our full-year revenue and our fourth quarter 2020 net revenue, which was $167.3 million, are record levels for Amarin. Our revenue growth was led by increased prescription levels of Vasepa in the United States. As you know, we launched the new PCVR indication for Visepa in January 2020. And in March 2020, consistent with most companies throughout the industry, we had to pull our sales team from the field due to the COVID-19 pandemic. Still, our team was able to pivot to digital platforms and other forms of outreach in education.

Our revenue growth was led by increased prescription levels of Vascepa in the United States.

As you know we launched the new P. CVR indication for Vascepa in January of 'twenty 'twenty.

And in March 2020, consistent with most companies throughout the industry. We had the poll our sales team from the field due to the COVID-19 pandemic.

Still our team was able to pivot to digital platforms and other forms of outreach and education.

Currently our field team in the United States is making face to face calls with accessible target healthcare professionals were allowed.

John Farrell: Currently, our field team in the United States is making face-to-face calls with accessible target healthcare professionals where allowed. However, change remains fluid due to COVID-19, particularly in various geographies.

[noise] change remains fluid due to COVID-19.

Particularly in various geographies.

John Farrell: Our commercial team remains committed and continues to adjust as needed in this unprecedented environment. Nonetheless, SIPA growth in 2020 was slower than initially expected due to COVID-19. FACEPA growth in 2020 compares well with the growth of peer drugs and, in fact, outpaced most other drugs indicated for cardiovascular disease treatment. In addition, we continue to make great headway with payers throughout 2020, and progress has continued into 2021. We have not yet solved the challenge of helping healthcare professionals diagnose and treat at-risk patients when patients avoid doctor visits and when patients avoid blood tests due to COVID-19 concerns.

Our commercial team remains committed and continues to adjust as needed in this unprecedented environment.

Nonetheless, while the Super growth in 2020 was slower than initially expected due to COVID-19 vascepa.

The Super growth in 2020 compares well with the growth of peer drugs.

And in fact outpaced most other drugs indicated for cardiovascular disease treatment.

In addition, we continued to make great headway with Payors throughout 2020, which progress has continued into 2021.

We have not yet solve the challenge of helping health care professionals diagnose and treat at risk patients when patients avoid doctor visits and when the patients avoid blood tests due to COVID-19 concerns.

We envision the opportunity for further growth as the impact of COVID-19 receives and patients begin returning to the health care professionals for preventative care.

John Farrell: We envision the opportunity for further growth as the impact of COVID-19 recedes and patients begin returning to their healthcare professionals for preventative care. There are millions of at-risk patients whose cardiovascular risk is untreated who are candidates for the cardioprotective benefits of Vasepa. We recognize that it was only 13 months ago that we launched Visepa for the PCVR indication.

There are millions of at risk patients, whose cardiovascular risk is untreated who are candidates for the cardio protective benefits of Vascepa.

We recognize that it was only 13 months ago that we launch Vascepa for the peak CVR indication.

We have much work remaining to effectively educate health care professionals and at risk patients regarding this new treatment option.

John Farrell: We have much work remaining to effectively educate healthcare professionals and at-risk patients regarding this new treatment option, this large market need, and limited market awareness of the SIPA. Combined with Visepa's already substantial growth, these are three reasons we are confident in our ability to grow branded vasepa in the United States. We are aware of generic competition, and we take all competition seriously.

This large market need and limited market awareness of the Vascepa.

Bind, but vascepa is already substantial growth.

Our three reasons, we are confident in our ability to grow branded vascepa in the United States.

We are aware of generic competition.

We take all competition seriously.

John Farrell: Nonetheless, we think that it would be a disservice to patient care in the United States and irresponsible to our employees and investors if we cease branded product promotion in the face of generic competition in this atypical generic market. Without further market education, the use of Vasepa will be unnecessarily limited, and patient care will suffer. If, for example, Visepa was a household name that had been promoted for a decade, or if Visepa was a high-priced product, our decision to continue promotion might be different.

Nonetheless, we think that it would be a disservice to patient care in the United States and in responsible to our employees and investors. If we cease branded product promotion in the face of generic competition in this a typical generic market.

Without further market education use of Vascepa will be unnecessarily limited and patient care will suffer.

If for example, Vascepa was a household name than it had been promoted for decade or F. Vascepa was of high priced product our decision to continue promotion might be different.

We believe that the upside potential from continued market expansion in the United States remains considerable.

John Farrell: We believe that the upside potential from continued market expansion in the United States remains considerable. From the start, we have priced Visepa to be affordable. Even price watchdog groups have commented that the pricing of a SEPA is cost effective.

From the start we have price vascepa to be affordable.

Even price watchdog groups have commented that the pricing of Vascepa is cost effective.

We could make money through the launch of an authorized generic product in the United States, but doing so would not maximize the revenue and profit potential of the product and would result in many health care professionals and at risk patients never learning about this important drug and it's still very recent.

John Farrell: We could make money through the launch of an authorized generic product in the United States, but doing so would not maximize the revenue and profit potential of the product and would result in many healthcare professionals and at-risk patients never learning about this important drug and its still very recent PCBR indication. In addition to Basipa being an atypical market for generics because of its affordable pricing and because it is not a mature market, As expressed previously,

A piece of CVR indication.

In addition to Vascepa being an atypical market for generics because of Vascepa is affordable pricing and because it is not a mature market.

As expressed previously.

John Farrell: Based upon industry data, the skinny label for the launch generic product covers no more than approximately 7% of Vaseepa's prescriptions or approximately $40 million in revenues per year based upon 2020 US net product revenue. We have patents covering VCEPA promotion for cardiovascular risk reduction, which is not in the label of the available generic product and was not contested in past ANDA litigation. Disappointing from a societal health perspective is that, to our knowledge, unlike Amarin, generic companies are not investing in market education or other initiatives to expand Visepa usage to help more at-risk patients, and they are not investing in clinical studies of Vasepa for other potential uses.

Upon the industry data.

The skinny label for the launch of generic product coverage no more than approximately 7% of Vascepa prescriptions.

Or approximately $40 million in revenues per year based upon 2020 of U S net product revenue.

We have patents covering vascepa promotion for cardiovascular risk reduction.

Cardiovascular risk reduction is not in the label of the available generic product and was not contested.

Pass and the litigation.

Disappointing from a societal health perspective is that to our knowledge. Unlike amarin generic companies are not investing in market education or other initiatives to expand vascepa usage to help more at risk patients and they are not.

<unk> and clinical study of Vascepa for other potential uses.

Also to our knowledge generic companies and their suppliers have not made the investments in capacity expansion, which amarin has made.

John Farrell: Also, to our knowledge, generic companies and their suppliers have not made the investment in capacity expansion which Amarin has made. Currently, there is only one launch generic in the market. And there have been reports of periodic stock outages for that product, creating week-to-week fluctuations in the level of prescriptions billed by retail pharmacies using the generic product. These fluctuations in generic product availability impact the level of prescriptions filled with branded Visepa. While capacity for generic competition may increase over time, based upon information available to us currently, we anticipate that capacity via their current suppliers will remain a fraction of the capacity of Amarin suppliers.

Currently.

There is only one launch generic in the market.

And there have been reports of periodic stock outages for that product, creating week to week fluctuations in the level of prescriptions filled by retail pharmacies with the generic product.

These fluctuations in the generic product availability impact the level of prescriptions filled with branded Vascepa.

While capacity for generic competition may increase over time.

Based upon information available to us currently.

We anticipate that capacity via their current suppliers will remain a fraction of the capacity of amarin suppliers.

Various insurance companies and patients have expressed to us that they have found the generic product to be more expensive than the branded product on a net price basis after factoring in applicable discounts.

John Farrell: Various insurance companies and patients have expressed to us that they have found the generic product to be more expensive than the branded product on a net price basis after factoring in applicable discounts. Drug pricing can be tricky. For example, the generic product can claim that its wholesale acquisition price is 12% below the price of the branded product. However, that reference is misleading as it is before rebates, discounts, and co-pay cards.

Drug pricing can be tricky, the generic product and claim that its wholesale acquisition price is 12% below the price of the branded product.

However that reference is misleading as it has before rebates discounts and co pay cards, the impact of which makes the net price of the branded product less expenses.

John Farrell: The impact of which makes the net price of the branded product less expensive. Clearly, various payers have not found the pricing of the generic product to be sufficiently compelling, as managed care coverage for branded Visepa has continued to improve overall since the generic product was launched in November 2020, apart from these market dynamics.

Clearly various payers have knocked down the pricing of the generic product to be sufficiently compelling.

As managed care coverage for branded Vascepa has continued to improve overall since the generic product was launched in November 2020.

Separate from these market dynamics Amarin filed a cardiovascular risk reduction patent infringement lawsuit against Hikma and of health care insurance company based upon various backs, including Hikma the promotion of its product in.

John Farrell: Amarin filed a cardiovascular risk reduction patent infringement lawsuit against HICMA and a health care insurance company based upon various facts, including HICMA's promotion of its product in a manner targeted at cardiovascular risk reduction uses, and the health insurer's coverage of the generic product for cardiovascular risk reduction, each of which we believe are part of a collection of activities that infringe our cardiovascular risk reduction patent path. We today have no update to provide regarding that litigation. We refer people to the court filings for more details.

The manner targeted at cardiovascular risk reduction users in the health insurers coverage of the generic product for cardiovascular risk reduction.

Each of which we believe are part of a collection of activities that infringe our cardiovascular risk reduction patents.

We today have no update to provide regarding that litigation.

We refer people to the court filings for more details.

Overall, we remain confident that there is a large market need for Vascepa and we believe we can grow this market faster than generics can take share.

John Farrell: Overall, we remain confident that there is a large market need for Visepa, and we believe we can grow this market faster than Generics can take share. We are motivated to succeed as doing so would be good for society. Patient Care and our shareholders. The first quarter of each year is historically a challenge for Visepa due to seasonal factors. In particular, in Q1 of each year, some patients elect to not fill their prescriptions for branded prescription medicines, such as VASIPA, due to beginning of the year deduction limits under their insurance plans. Such deduction limits go into effect at the beginning of each calendar year under many insurance plans.

We are motivated to succeed as doing so would be good for society.

<unk> care.

And our shareholders.

The first quarter of each year is historically a challenge for vascepa due to seasonal factors.

In particular in Q1 of each year, some patients elect to not fill their prescriptions for branded prescription medicines.

Such as Vascepa due to beginning of the year.

Duction limits under their insurance plans.

Such deduction limits go into effect at the beginning of each calendar year under many insurance plans.

John Farrell: Due to this seasonality, we encourage investors to continue to review Visepa growth on a year-over-year basis, in addition to the prescription growth we expect to experience as we progress beyond these seasonal factors. We anticipate an acceleration in Visepa growth as the impact of COVID-19 recedes. In recent months, you have likely read multiple accounts of increased rates of heart attacks and other cardiovascular events. These increases have been attributed to patients not seeking preventative cardiovascular care due to COVID-19.

Due to the seasonality we encourage investors to continue to review of Vascepa growth on a year over year basis.

In addition to the prescription growth, we expect to experience as we progressed beyond the seasonal factors.

We anticipate an acceleration in vascepa growth as the impact of COVID-19 receipts.

In recent months, you've likely read multiple accounts of increased rates of heart attacks and the other cardiovascular events.

These increases have been attributed to patients not seeking preventative cardiovascular care due to COVID-19.

You likely all of the also witnessed a resurgence of COVID-19 in the fourth quarter of 2020.

John Farrell: You likely also witnessed a resurgence of COVID-19 in the fourth quarter of 2020. As a result of that resurgence, we pulled back on certain of our promotional initiatives, including television advertising. As patients get vaccinated and begin to return to their doctor's offices for non-urgent care, we anticipate Visepa becoming part of the prescribed treatment regimen for at-risk patients. When the impact of COVID-19 recedes, it is our intention to restore various of our promotional initiatives. Currently, we are planning for this to begin occurring in the second quarter of 2021.

As a result of that resurgence, we pulled back on certain of our promotional initiatives, including TV advertisement.

As patients get vaccinated and begin to return to their doctor's offices for non urgent care.

We anticipate vascepa increasingly becoming part of the prescribed treatment.

For at risk patients.

When the impact of COVID-19 receipts it is our intention to restore.

Various of our promotional initiatives.

Currently we are planning for this to begin occurring in the second quarter of 2021.

Next I will comment on the progress, we're making towards approval and commercial launch in Europe.

John Farrell: Next, I will comment on the progress we are making towards approval and commercial launch in Europe. In late January, we were delighted to receive a positive CHMP opinion for occosaminethyl under the brand name Vazqepa for cardiovascular risk reduction. And we now expect a final approval decision from the European Commission in April. Over the past six months, we have been accelerating the building of commercial infrastructure to support commercial launch in Europe. And we now have a dynamic team of more than 50 experienced professionals in place, which we expect to grow to approximately 200 people by year end 2021.

In late January we were delighted to receive a positive <unk> opinion for a closer to an Apple under the brand name best kept up for cardiovascular.

Ask of the risk reduction.

And we now expect a final approval decision from the European Commission in April.

Over the past six months, we have been accelerating building commercial infrastructure to support commercial launch in Europe.

And we now have a dynamic team of more than 50 experienced professionals in place.

Which we expect to grow to approximately 200 people by year end 2021.

The people we have hired thus far are very impressive and we are making important progress in preparing for <unk> <unk>.

John Farrell: The people we have hired thus far are very impressive, and we are making important progress in preparing for Vaskefa's... Commercial launch in Europe. As previously reported, we are planning for a staged launch on a country-by-country basis in Europe based upon reimbursement availability, likely starting in Germany. We continue to engage in pre-labeled market access dialogues where permitted, and we are preparing for more formal discussions with national agencies regarding product pricing

Commercial launch in Europe.

As previously reported we are planning for a stage launch on a country by country basis in Europe based upon reimbursement availability likely starting in Germany.

We continue to engage in pre label market access dialogues where permitted.

We are preparing for more formal discussions with national agencies regarding product pricing once <unk> received approval from the European Commission.

John Farrell: Orange Vescapa received approval from the European Commission. Further discussion of our approach to market access in Europe is outlined in one of our FAQs in the Investor Relations section of our website. While market access negotiations will vary from country to country, we believe that we are well positioned to achieve reasonable pricing based upon the high rate of cardiovascular events in Europe, the lack of approved therapy for the indication for which VEZCAPA is positioned to address, the demonstrated efficacy and safety profile of this unique drug, and the history of reimbursement for this important drug, particularly in Canada, which is also a government-run health care system, and in the United States.

Further discussion of our approach to market access in Europe is outlined in one of our faqs and the Investor Relations section of our website.

While market access negotiations will vary from country to country. We believe that we are well positioned to achieve reasonable pricing based upon the high rate of cardiovascular events in Europe. The.

The lack of approved therapy for the indication for which the best camera is positioned to address the.

Of the demonstrated efficacy and safety profile of this unique drug.

In the history of reimbursement for this important drug, particularly in Canada, which is also of government run health care system.

And in the United States of course.

Okay.

John Farrell: The approval and launch of ASCEPA in Europe represents an exciting opportunity for Amarin to make a difference in the lives of millions of patients who are at risk for cardiovascular events. Regarding the opportunity for Visepa in China, our partner Edding has made considerable progress. Last November, we shared positive data from Edding's Phase III clinical study of basifa in China. In January, we were delighted to share that cibicent ethyl was added to the Chinese Society of Cardiology's treatment guidelines.

The approval and launch of Vascepa in Europe represents an exciting opportunity for amarin to make a difference in the lives of millions of patients who are at risk for cardiovascular events.

Regarding the opportunity for Vascepa in China, our partner, adding has made considerable progress.

Last November we shared positive data from adding space III clinical study of Vascepa in China.

In January we were delighted to share that of course about Apple was added to the Chinese society of cardiology treatment guidelines, increasing to 13, the number of medical societies, which have included iqos of an apple and their medical treatment guidelines.

John Farrell: Increasing to 13 the number of medical societies which have included icosavent ethyl in their medical treatment guidelines or otherwise recommended use of this important drug for cardiovascular risk reduction in at-risk patients. Earlier this month, regulatory authorities in China, the Chinese NMPA, accepted Edding's new drug application for review of Visepa, which is another milestone on the path to approval for Eddington. Adding currently anticipates receiving approval of the FIPA in mainland China near the end of 2021, and also anticipates approval of the ZIPA in Hong Kong near the end of 2021, with approximately 180.4 million hypertriglyceridemia patients in China in 2019, and a history of rapid adoption of statin therapy in China.

Our otherwise recommended use of this important drug for cardiovascular risk reduction in at risk patients.

Earlier this month regulatory authorities in China, the Chinese and MPA excepted Eddings, new drug application for review of Vascepa.

Which is another milestone on the path to approval for adding.

Adding currently anticipates receiving approval of Vascepa in mainland China near the end of 2021.

And also anticipates approval of Vascepa in Hong Kong near the end of 2021.

With approximately $180 4 million hybrid triglycerides EMEA patients in China in 2019.

And of history of rapid adoption of statin therapy in China.

John Farrell: There is a significant medical need and a meaningful market opportunity for Amarin and Edding. Regarding the rest of the world, our commercial partners in Canada and the Middle East continue to make progress, and Amarin is eyeing other potential international opportunities for BASIPA after we progress this important product to approval and market access in Europe. We do not want commercialization in these smaller markets to distract us from what needs to be accomplished in Europe.

There is a significant medical need and a meaningful market opportunity for amarin and adding.

Regarding the rest of the world our commercial partners in Canada, and the Middle East continued to make progress in Amarin is eyeing other potential international opportunities for Vascepa. After we progressed this important product to approval and market access in Europe.

We do not want commercialization in the smaller markets to distract us from what needs to be accomplished in Europe.

With that update and review, let me turn the call over to Mike Cobb, our CFO for a more detailed discussion of our financials Mike.

Michael Kalb: With that update and review, let me turn the call over to Mike Cobb, our CFO, for a more detailed discussion of our financials. Mike?

Thanks, John we encourage investors to review our 2020 annual report on form 10-K now of corresponding press release issued this morning.

Michael Kalb: Thanks, John. We encourage investors to review our 2020 Annual Report on Form 10-K and our corresponding press release issued this morning. Both of these can be found on our website. They contain a discussion of our fourth quarter and full year financial results, including various details which go beyond the highlights I will cover in today's call. John noted our record levels of net revenue in both the full year and the fourth quarter of 2020. These increases were driven primarily by increased volume of SIPA sales to customers in the United States. The net price of the SIPA, while it increased modestly in 2020, has essentially remained flat for many years.

Both of these can be found on our website contain discussion of our fourth quarter and full year financial results, including various details which go beyond the highlights I will cover in todays call.

John noted our record levels of net revenue in both the full year and the fourth quarter of 2020.

These increases were driven primarily by increased volume of Vascepa sales to customers in the United States.

The net credits of Vascepa, while it increased modestly in 2020 has essentially remained flat for many years.

It is not possible to quantify the impact of COVID-19 on our 2020 net revenue, although we are certain that such impact was significant.

Michael Kalb: It is not possible to quantify the impact of COVID-19 on our 2020 net revenue, although we are certain that such impact was significant. Additionally, while it is also not possible to quantify the impact of the generic product launch in November 2020 on our net revenue, we do not believe such loans had a material impact. We do not break out operating results by geography.

Additionally, while it is also not possible to quantify the impact of the generic product launched in November 2020 on our net revenue we do not believe such launch had a material impact.

We do not break out operating results by geography.

Michael Kalb: However, the contribution to our business from commercial operations in the United States has been improving while we have commenced making increased investment in Europe. As mentioned earlier this year, Amarin anticipates 2021 operating expenses of approximately $550 million to $600 million, which represents an increase of approximately 10% to 20% compared with 2020 levels. Included in these anticipated expenses are increased costs associated with Amarin's commercial launch preparations and initial launch in Europe as well as continued U.S. promotional activities.

However, the contribution to our business from commercial operations in the United States has been improving while we have commenced making increased investments in Europe.

As mentioned earlier this year Amarin anticipates 2021 of operating expenses of approximately $550 million to $600 million, which.

That's an increase of approximately 10% to 20%.

Compared with 2020 levels included in these anticipated expenses or increased cost associated with the amarin commercial launch preparations and the initial launch in Europe as well as continued U S promotional activities.

Michael Kalb: Also included in these anticipated expenses is an assumed sales force in the U.S. of approximately 750 to 800 professionals consisting primarily of sales representatives and their managers. Due to the uncertainties regarding COVID-19 and potential generic supply, Amarin will continue to withhold 2021 revenue guidance for Visepa in the U.S. until there is greater clarity on the impact of these issues. As of December 31, 2020, Amarin reported aggregate cash investments of $563.4 million, consisting of cash and cash equivalents of $187 million, and liquid short-term and long-term investments of $314 million and $62.5 million, respectively.

Also included in these anticipated expenses as an assumed sales force in the U S of approximately 750 to 800 professionals, consisting primarily of sales representatives and their managers.

Due to the uncertainties regarding COVID-19, and potential generic supply amarin.

Amarin will continue to with call of 2021 revenue guidance for Vascepa in the U S until there is greater clarity on the impact of these issues.

As of December 31, 2020 of Amarin reported aggregate cash and investments of five.

$563 $4 million, consisting of cash and cash equivalents of $187 million and liquid short term and long term investments of $314 million and 62, and a half million dollars respectively.

Michael Kalb: Furthermore, during the fourth quarter of 2020, we paid off our final royalty-like debt, which previously was 10% of net product revenues since SIPA was launched. We now have no debt. We reiterate that, based on our current plans, we believe that our existing resources are sufficient to fund Vizcapa's launch in Europe and to get us to cashflow positive on a consolidated basis. With that financial overview, I will now turn the call back to Jon for closing remarks. Jon?

Furthermore, during the fourth quarter of 2020, we made our final royalty like debt payment.

Previously it was 10% of net product revenue since the simple was launched.

Now have no debt.

We reiterate that based on our current plans, we believe that our existing resources are sufficient to fund west campus launch in Europe and to get us to cash flow positive on a consolidated basis.

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

John Farrell: Thanks, Mike. Like all of you, we enter 2021 with great hope that the vaccines developed by our industry colleagues will stem the tide of the global COVID-19 pandemic, yet aware that there will continue to be a need for effective therapeutics as well. Towards that end, we maintain our support of multiple investigator-sponsored studies of eicosapent ethyl to treat and prevent COVID-19. The first of these studies demonstrated encouraging results.

Thanks, Mike.

Like all of you we enter 2021 with great hope that the vaccines developed by our industry colleagues will stem the tide of the global COVID-19 pandemic.

Yet aware that there will continue to be of need for effective therapeutics as well.

Towards that end, we maintain our support of multiple investigator sponsored studies of Iqos spend apple to treat and prevent COVID-19.

The first of these studies demonstrated encouraging results.

John Farrell: After we see further study results, we will assess the potential role of Visepa related to COVID-19 and other infectious diseases where inflammation is an issue. Amarin has a very dynamic year ahead. 2021 is a year of execution for Amarin, and we are working hard to attain our goals, including meaningful growth of branded VISIPA revenue and contribution in the United States, the successful approval and launch of ESCEFA in Europe, the successful approval of SIPA in China, and continued scientific advancement leading to potential new market opportunities.

After we see further study results, we will assess the potential role of Vascepa related to COVID-19, and other infectious diseases, where inflammation is an issue.

Amarin is a very dynamic year ahead.

21 as of year of execution for Amarin and.

And we are working hard to attain our goals, including meaningful growth of branded Vascepa revenue and contribution in the United States.

The successful approval and launch of <unk> in Europe.

The successful approval of Vascepa in China.

And continued scientific advancement, leading to potential new market opportunities.

John Farrell: I'd like to take this opportunity to express my gratitude to the Amarin team, including our employees, our commercial partners, suppliers, and the scientists and physicians supporting Visepa's scientific, regulatory, and commercial advancement. And I thank our shareholders for your continued support and encouragement as we advance this new paradigm in cardiovascular risk management. With that, operator, we are now ready to open the call to questions.

I'd like to take this opportunity to express my gratitude to the Amarin team Inc.

Including our employees, our commercial partners suppliers, and the scientists and physicians supporting Vascepa scientific regulatory and or commercial advancement.

And I, thank our shareholders for your continued support and encouragement as we advance this new paradigm and cardiovascular risk management.

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

Thank you ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone at this time, we asked a lot of posing your question you. Please pick up your handset of listing on speaker phone to provide optimum sound quality.

Operator: Thank you. Ladies and gentlemen, the floor is now open to questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while asking your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we pull for questions. And the first question is coming from Louise Chen. Louise, your line is live. Please announce your affiliation and ask your question.

Hold while we poll for questions.

And the first question is coming from Louise Chen Louise Your line is live please announce your affiliation and pose your question.

Louise Alesandra Chen: Hi, Louise Chen with Cantor. Thanks for taking my questions here. So I had a few questions. The first question I had was, how should we think about this first quarter 21 sales for Vasipa given the pandemic headwinds that we had this year when compared to last year? And then the second question I had was, what gives you confidence that you can continue to grow faster than the market for generics, even if more generics can enter the market later this year? And then the last question I have is, what do you think about the peak end market sales in China and what that means to you in revenue? Thank you.

Hi, Louise Chen with Cantor <unk>. Thanks for taking my questions here. So I had a few questions. First question I had was how do you think we should think about this first quarter 'twenty one sales for Vascepa given the pandemic headwinds that we had this year when compared to last year and then the second question I had was what keeps you.

Confidence that you can continue to grow faster than the market for generics, even if more of generics can enter the market later this year.

And then last question I have is how do you think about the peak end market sales in China, and what that means to you and revenue. Thank you.

Louise Good morning, it's John.

John Farrell: Louise, good morning. It's John.

John Farrell: Thanks for the questions. With respect to Q1 sales, you know, we're in the middle of the quarter, and I'm not going to comment too much on the activities in the middle of the quarter, but, As we commented during the prepared remarks, you know, there are a couple of headwinds that we faced in the first quarter. One, of course, is COVID.

John Thanks for the questions.

With respect to Q1 sales.

Yes, we are in the middle of the quarter and just comment too much on the middle of the quarter of activities, but.

As we commented during the prepared remarks together a couple of headwinds that we have.

In the first quarter one of the horses.

As COVID-19.

John Farrell: Um

And that's been volatile of certainly there's some.

John Farrell: And, you know, that's been volatile. Certainly, there's been some good news in the media recently about event rates going down. We've seen periods in the past, like we saw in sort of the September-October time framework, as COVID, you know, pulled back the prescriptions in the United States for Mesquita, you know, went off. I think it's early to be predicting that, but, you know, whether that's immediate or whether that's more of a Q2 phenomenon, we are hopeful and have confidence that that's going to happen.

Good news.

The media recently about.

Of that range going down and we've seen periods in the past like we saw in sort of the September October time framework as Covid pulled back the.

Prescriptions in the United States of the steeper.

Went up I think it's too early to be predicting that but.

Whether that's the immediate or whether that's more of a Q2 phenomenon.

We are hopeful.

The confidence that that's going to.

Going to happen.

Two is the the impact of the <unk>.

Generics.

There appears to be.

Absolutely the fixed here very weak.

John Farrell: You know, two is the impact of the generic supply, which appears to be, you know, relatively fixed here, varying week to week, but it is taking a slice that, you know, it's quantified. It bounces up and down.

Week to week, but as.

As you take a slice of that.

I think moving to see the numbers.

Out of Pfizer.

Bounces up and down and then of course, there is headwinds that we'd get seasonally every Q1 and the.

John Farrell: Then, of course, there's those headwinds that we get seasonally, every Q1, and particularly in the January and February timeframe has an impact. And for those who aren't familiar with that, you can think about a drug like Vasepa, which if somebody has insurance in a co-pay card, they can get for $9 for a 30-day supply. But that co-pay card doesn't pick up every dollar from dollar one if somebody doesn't have insurance. So if a patient has a $3,000 deductible on their insurance, and these patients tend to be on multiple therapies, if they are used to paying $9 here and $25 there and $30 there, and maybe a monthly bill of $100 for their portfolio therapies, and they've got a $3,000 deductible, they go in in January to get their prescriptions filled instead of it being an aggregate tab for the five of them of $100, they come back with a charge of $3,000.

No.

Particularly in the January and February timeframe has impact and for those who aren't familiar with that.

You can think about the drug like Vascepa.

So somebody out of the insurance the copay card they can get hurt.

The $9.

30 day supply.

The copay card doesn't pick up every dollar of dollar one of somebody who doesn't have.

Insurance so if the.

The patient has a.

<unk> $3000 deductible or their insurance of these patients tend to be on multiple of.

Therapies of they are used to paying of.

$9 here in 'twenty $5 there of $30 there.

Maybe a monthly bill of $100 further portfolio of therapies and they've got of $3000 deductible.

And in January to get their prescriptions filled instead of putting them in.

In aggregate for the five of them over $100 and come back for the <unk>.

As of $3000.

John Farrell: Those patients end up filling their pain meds, but many of them just can't afford to fill all their medications, so they don't fill something as important as preventative cardiovascular care. And then, historically, we've seen a sort of rebound in those prescriptions in March and then particularly in April and May. So we're counting on that type of thing happening here.

And of those patients and the filling their pain meds.

But the.

Maybe I'm just can't afford to fill all of other medications. So they are they don't feel something as important as preventative cardiovascular care than historically.

We've seen them.

Sort of a rebound in those scripts and margin that particularly in April and May. So we're counting on that type of thing happening here.

John Farrell: Again, in the first quarter, the promotion that we have been doing because of COVID, we did pull back a bit during the fourth quarter and have continued to be somewhat constrained here in the first quarter relative to promotion. You've not seen as much television advertising, for example; we're preserving those resources with the view that as COVID pulls back further, we will ramp that up. So we're currently anticipating year over year growth in the first quarter versus last year, but we're not providing any quantified guidance on it at this point in time. With respect to why we believe that we can grow, you know, faster than generics, you know, that's a, that's a...

Again in the first quarter.

The promotion that we have been doing because of Covid, we did pull back a bit in the.

During the fourth quarter and have continued to be somewhat constrained here in the first quarter relative to promotion.

As soon as my TV advertisement for <unk>.

Example of where.

Preserving those resources with the view that as Covid pulls back further we will.

Ramp that up so we're currently anticipating.

Dissipating year over year growth in the first quarter of versus versus last year, but we're not providing any quantified guidance side of it.

At this point in time.

With respect to.

Why do we believe that we can grow faster than.

Generics.

That's a complex topic.

And you know I would begin with the fact that this really is very much of an atypical of generic market.

John Farrell: I would begin with the fact that this really is very much an atypical generic market, atypical in the sense that for the generic that's launched, greater than 93% of the use is off-label. As I discussed with Steve, it's not a mature market, most people don't know about it, yet this is a multi-billion dollar opportunity that we just launched into 13 months ago. We just began the launch, we're focusing on patient education, and this is not an expensive product, so it's not like generics are coming in and rushing off to the generic because it's less expensive.

A typical on the status of that.

The the generic is launched.

The 93% of the users.

Well the label.

As discussed the shippers non mature market most people don't know about it yes. This is the most.

Type of $1 billion opportunity that we think we are.

No.

We've just launched end of 13 13 months ago, We just began the launch.

We're focusing on patient education, there is a lot of expense of product. So it's not like the generics coming in every rushing off of the generic because it's.

It's less expensive to the contrary, we've seen managed care coverage.

John Farrell: On the contrary, we've seen Medicare coverage continue to expand, and then the manufacturer of this product requires significant investment that Amarin has made and supported over multiple years to create efficiencies, but the lead time of the year for product suppliers is long and expensive, so it probably contributes to why only one of the three approved generics has launched at this point in time, and the one that has launched has commented that although there are gross margins on that product, they're lower I remind you that Epidel, which is an ETA-based product in Japan, has been generic for over a decade, and it's still greater than 60% branded, so we think it is the right thing for patient care for us to continue to focus on increased promotion in the United States. I know our sales team in the field is confident.

We continue to expand and then you know.

Of the manufacture of this product requires significant investment the amarin has made.

Supported over multiple years to create efficiencies, but the lead times here for the product suppliers as long.

The net expenses so it probably contributes to why only one of the three approved generic launch of this.

The point in time and the one that is one just commented that.

The gross margins on that product is lower than what it is for.

The other products because of the high relatively high cost for the.

Our production of.

This high quality.

The complex product to manufacture I remind you the Tampa Dallas sneak day based products in Japan has been generic for.

Over a decade, and it's still greater than 60%.

The brand itself. We think it is the right thing for patient care for us to continue to focus on increased promotion United States I know our sales team and the deal the confidence that we can grow and what we need to do is have patients go back to their doctors and I think of the patients were regularly going to the doctor before ordinary care, we will be growing at a rate.

John Farrell: Well, what we need to do is have patients go back.

John Farrell: to their doctors. And I think if patients were regularly going to the doctors for ordinary care, we would be growing at a rate that would be convincing to many people that we should be able to grow faster than generics. This is just a big, big market. And, of course, and a topic in generics is EUS only. In Europe, for example, there are 10 years that we're expecting regulatory exclusivity and then patents that could take us out, potentially as long as 2039. What was your third question?

It would be convincing to many people that we should be able to grow.

After the generic this is.

But the big Big market.

Of course the.

And the.

And the topic of generic as the U S only and in Europe. For example is 10 years of what we're expecting the regulatory exclusivity of the patents that could take us out potentially as long as the <unk>.

<unk> 39.

What was your third question.

John Farrell: Peak sales in China. That's right. So I think there we need to recognize it's a very large market in China. Unfortunately, cardiovascular disease is a global phenomenon. We're working with a very good partner within Anyfarm. They've got a lot of experience in taking products through the reimbursement process, which in China will be important as it is in Europe. And we've put together a very good team in Europe to handle this. But we first need to get the product approved in China and see what the label ends up being.

Peak sales of China.

Right right right.

So.

I think there we need to recognize that the very large markets and China. Unfortunately cardiovascular diseases.

Global phenomenon, we're working very good partner, we've been adding farm.

Lot of experience of chicken products through the you know the reimbursement process.

China will be important as it is.

In Europe.

We put together a very good team in Europe.

The handle as we first day to get the product approved in China.

And.

John Farrell: And I don't want to step on the toes of adding, you know, they're responsible for the pricing there. We've got some say in it, but let's get these labels first. And then they will go province by province toward approval. But the rate of uptick of... Spatin use has been high in China, and certainly, the cardiovascular need is

See what the label.

Being and I don't want to step on the toes of adding they are responsible for the for the pricing there we've got some say it but the.

Let's get the label first and then they will go province by Province inventories the approval.

The range of uptick of.

Statin use has been high in China, and certainly the cardiovascular need is high in China I would remind.

John Farrell: I would remind

John Farrell: I'd like to remind folks that the terms of our agreement with Edding is that there are various... You know, milestone real base payments, but also we will be manufacturing the product for them and doing that on a cost plus basis and then there are tiered royalties on top of that, that, you know, are, Starting in double digits and sort of escalating up, uh, uh, you know, through, through, through that. Um, so it's a, it's a big, big potential opportunity for us, but let's get it, let's get it approved first, see what the label is, and then, uh, you know, go through the provinces for reimbursement before we get into too much quantification there. So I'm, uh, again, I don't want to step on Eddie's toes there, they're a terrific partner. Hopefully those comments are helpful. Yes.

Folks on the terms of our agreement with out of adding is that.

There are various.

Milestone based payments, but.

So we will be manufacturing the product for them in doing that on a cost plus basis.

And then there are tiered royalties on top of that.

Our.

Starting in double digits and sort of escalating up.

Through.

Through through that so.

So.

Big Big potential opportunity for us so that's kind of.

Got it approved <unk> two of the label is and then go through the provinces for reimbursement of before we go the two much quantification.

Sure.

Hum.

Again, I don't want the debt by adding the toes there of their perfect partner.

Hopefully those comments are helpful.

Yeah. Thank you.

Louise Alesandra Chen: Yeah, thank you.

Thank you and the next question is coming from Ken Cacciatore Cowen. Your line is live please announce your affiliation and pose your question.

Operator: Thank you. And the next question is coming from Ken Cacciatore. Ken, your line is live. Please announce your affiliation and ask your question.

Ken Cacciatore: Hi, it's Ken with Cowen. Thanks, John, for all the details. I appreciate them. Just wondering if you could give us a sense of what would be the best analog that you would like to point us to in Europe in terms of pricing, any recent cardiovascular bit more detail on how you're going to try to strike that relative balance. Thanks so much.

All of its kind of with Cowen. Thanks, John for all of the details of appreciate them. Just wondering if you could give us a sense of what would be the best the analog that you would like the point those two in Europe in terms of pricing any recent party of vascular.

The product that you think would be best of comparison, Nate maybe a sense of where the kind of average branded statin pricing was and Ah if any nuance around that would be wonderful and then just thinking about the U S spending as he as you embark on the the European opportunity.

John Farrell: Hey Ken, good morning. Thanks for the questions, and I'll give you some free advertising. We're looking forward to being at your conference next week, where I'm sure you'll have many other questions for me. You know, with regard to analog in Europe, I think one of the things that I would emphasize, and I think this is positive, is that really there is no good analog. And, you know, the way that...

It sounds like Youre going to try to nuance a little bit obviously be as aggressive as you can in the U S, but be thoughtful about how that balances the against the investment in Europe, just wanting a little bit more detail on how you're going to try to strike that that relative balance. Thanks. So much.

John Farrell: Reimbursement work from a market access perspective being a unique product in that perspective is probably probably a good thing. So, I think what we can point to is that from a pharmacal economic perspective, the cost of things like heart attacks and strokes is very expensive and not only at the time of occurrence. But it's something like a stroke, you know, go on for a cost that can go on for years. So, you They're also were effective in Canada.

Hey, Ken Good morning, Thanks for the questions and the.

Give me the free advertising of our looking forward to being at your conference net.

Next the next week, where I'm sure you'll have any other questions for me.

With regard to an analog in your I think one of the one other things of that.

John.

I would emphasize and I think the positive is really there is no good.

In analog.

And the way that.

Reimburse the word for market access perspective, being a unique product net perspective, probably of probably a good thing. So I think what we can point to is that pro forma growth economic perspective that the cost of things like heart attacks strokes are very expensive.

John Farrell: You know, Canada is also of course a single-payer government system or largely so and You know, we and our partner there were pleased that reimbursement came along Faster than what we expected and I think follow the form of economic arguments to provide a reasonable price Number so as we go into Europe You know, there really is no direct analog what there is is a very substantial market of patients with persistent cardiovascular risk for which there is no therapy today a Product in Vizcaya, you know that has proven outcomes data Usually products aren't launching with outcomes data, you know which also sort of takes away and analogs for other products and it's you know, it's first in market and already has Recommendations from the two leading medical societies a European Society of cardiology and the European athletes grosses You know society so we're looking forward to a launch in Europe That's you know considerably different than the launch we had in the United States when we launched the United States It was a step launch, you know based off of initial biomarker Change indication, you know lowering, you know, very high, you know triglycerides We didn't have outcomes data. There's lots of generic, you know Competition and it was a niche market Europe.

Only at the time of accounts, but it sounds like a stroke going for the cost can go on for years. So those kinds of the farm of economic arguments have been effective in the United States. They are also were effective in Canada.

Also of course.

Single payer government.

System are largely solved and.

We and our partner there were pleased that reimbursement came along faster than what we expected and I think follow all of the farmer of economic arguments to provide a reasonable price numbers. So.

We go into Europe.

You know there really is no.

Correct analog what there is is a very substantial market of patients with persistent cardiovascular risk.

There is no therapy today.

The product is but Scott you know that.

It has proven outcomes data usually products aren't launching with outcomes data, which also takes away and analogs for other products.

The first to market and it already has.

Recommendations from the two leading medical societies of European Society of Cardiology, and the European assets grosses.

Society. So we're looking forward to a launch in Europe, Thats youll considerably different than the launch we had in the United States when we launched the United States.

It was a step launch you know based off of initial biomarker change indication the lowering of very high triglycerides, we didn't have outcomes data.

Lots of generic <unk>.

Competition, and there was a niche market in Europe, we're going in with the outcomes data.

John Farrell: We're going in with outcomes data, and You know, no, you know, no direct competition. I think we should, in Europe, like we've done in the United States, focus on how can we get this? Reimbursed in a way that we can help as many people as we can. In terms of at-risk patients in Europe, market access, of course, is a country-by-country proposition in Europe, and we've talked about in the past how we'll be looking to prioritize that. With regard to spending...

<unk>.

No no direct competition and I think.

We should in Europe like we've done in the United States.

Because of how can we get this.

Reimbursed in a way that we can help as many people as we can.

In terms of at risk patients.

In Europe market access of course is a country by country Yo proposition in Europe.

And we've talked about in the past how would you.

Prioritize that with regard to spending.

John Farrell: The, you know, Amarin's increasing popularity has become

The amarin is increasingly becoming a multinational company.

John Farrell: becoming a multinational company. For years, we limited resources, sort of starved what we were doing in the United States commercially, as we focused them on investment in R&D, particularly for the reduced study. And then after the positive results of the reduced study in late 2018, we began building our U.S. commercial infrastructure and expanded that further in late 2019. And, of course, doubled it coming into 2020, started the launch, and then got slowed down here by COVID. Throughout these past really two years, the overall business, on a cash flow basis, has generally operated pretty close to cash flow neutrality. We've had some quarters of slightly positive cash flow, and some quarters of slightly negative.

For years with limited resources sort of star, but we're doing in the United States commercially as we focused in on investment in R&D.

For particularly for the reduce it study.

And then after the positive results of the reduce the study in late 2018, we began building our U S commercial infrastructure and expand that further.

In late 2019 and of course, the doubling of coming into 2020 started the launch and then got slowed down here by the Covid.

Throughout this past really two years the AUM.

Overall business on the cash flow basis has had.

Generally operating pretty close to cash flow neutrality, we've had some quarters of slightly positive.

The slightly.

So slightly net.

Net negative.

John Farrell: Our view is that while we'll be variable from quarter to quarter, we should be growing revenues in the United States, and the spending may be somewhat variable, but we're looking forward to both increased revenues and increased positive contribution coming from our U.S. activities. European investment, we think is important. The pace of that investment is the sort of irony of the faster the countries get market access, the faster that we would be potentially spending in Europe. But that, of course, then translates into revenues coming in faster as well. So in Europe right now, we've got a.., a core team.

Our view is that while it will be variable from quarter to quarter.

That we should be growing revenues in the United States.

And the.

We expect the spending maybe somewhat variable but.

We're looking forward to both increased revenues and increased.

The positive contribution coming from our U S activities the European investment.

We think is important.

Of that investments as sort of of the irony of the.

The faster the countries to get market access the batches that we would be potentially spending in Europe without of course, then translates into revenue coming in faster as well so in Europe right now we've got a.

A core team.

John Farrell: And, you know, of course, our... Corporate team in Dublin, a core sort of marketing team set up in Switzerland, and then a field team that we've started to put together for Germany, you know, on a non-branded basis, working on, you know, market awareness. Once we get approval, which we're anticipating in the April timeframe, we'll be able to ramp up that, you know, sort of pre-launch So we've talked about the size of the sales, the size of the team in Europe increasing during this calendar year to approximately up to 200 people.

And of.

Of course are.

The corporate team in Dublin, the core sort of marketing team set up in Switzerland, and then.

The field team that we have starting to put together for Germany on a non branded basis working on.

But awareness.

Once we get approval, which we're anticipating in the April timeframe, we'll be able to ramp up that kind of sort of.

Free launch promotion.

And then.

Assuming the <unk>.

The launch in Germany, and potentially other countries subject to the market access. So we've talked about the size of the sales of size of the team in Europe, increasing during this.

Calendar year to approximately 200 people that's the assumes a certain level of market access of the market access is faster than that we would.

John Farrell: This assumes a certain level of market access. If market access was faster than that, we would, you know, increase our spending, you know, faster than that. If we're promoting in, say, Germany, and, you know, that begins to come up with speed and get revenues, you know, that begins to pay for itself, and, you know, then that's less of a burn as we go into other countries. If we're getting market access faster in other countries, you know, maybe we're launching, you know, a little more simultaneously; the amount of spend will differ, you know, based upon that.

The increase our spending faster than that.

We're promoting in say Germany.

That's against the speed and get revenues.

The paper itself.

So then that's less of a burn as we're going into other countries of forget market access faster in other countries, maybe we're launching.

A little more simultaneous the amount of spend will differ based upon that.

John Farrell: But in any of those cases, we believe that our current capital resources are sufficient to, you know, make the investment necessary to be successful in Europe. But first we need to get some regulatory approval, then we need to get started on market access. We need to do some, you know, pre-launch, you know, education, and then get out into launching in each country. And as we do so, we'll certainly have much more feedback relative to spending.

Any of those cases, we believe that our current capital resources are sufficient to make the investment necessary to be successful in Europe, but first we need to get the.

The regulatory approvals that we need to get started on the market access.

We need to do some of it.

Prelaunch, no indication of that you'll get out into launching in each country and as we do so we will certainly have much more feedback relative to spending.

John Farrell: You know, the European market focus for us should be a bit more concentrated than it is in the United States. Probably not the need there for television advertisements, much more maybe a digital focus. And, you know, there's a bit more concentration of at-risk patients with cardiologists in Europe, which we think will help as well. So I know I haven't provided much quantification there, but at least that's some background information that may be useful to you.

The European market.

Focus for us should be a bit more concentrated than it is in the United States, probably not the need therefore, TV advertisement much more maybe of the digital digital focus.

And there.

There is a bit more concentration of at risk patients with cardiologists in Europe, which we think will we'll hope.

As well so I don't I Havent provided a bunch of quantification there, but at least that some background information that may be useful to you.

Okay looking forward of the conversation next week. Thanks, so much.

Ken Cacciatore: Okay, thanks. Looking forward to the conversation next week. Thanks so much. Thanks again.

Scott.

Operator: Thank you, and the next question is coming from Michael Yee. Michael, your line is live. Please announce your affiliation and ask your question.

Thank you and the next question is coming from Michael <unk>, Michael Your line of live please announce your affiliation and pose your question.

Dennis Ding: Hi, this is Dennis Ding on behalf of Michael E. S. Jeffries. Congratulations on all the progress.

Hi, This is Dennis thing on for Michael Yang of Jefferies.

Congratulations on all of the progress I just have two questions.

John Farrell: I just have two questions. One about the US and one about Europe. So, in the US, generics have been launched for about a quarter now. How often do you guys encounter generics on the ground? And what are physician prescribing patterns in areas where you're having to compete with them? Or does this decision happen at the pharmacy, and how has that changed from Q4 to Q1? And then my second question on Europe: have you been engaging in conversations with potential partners, and has there been a lot of interest, and what are their biggest areas of pushback? Thanks so much.

On the U S. In one part of Europe. So.

So in the U S.

Generics have launched for about a quarter now how.

How often do you guys can counter of generics on the ground.

And what are the physician prescribing patterns in areas, where you're having to compete with them.

Art this decision happened at the pharmacy, and how has that changed.

From Q4 in the Q1 and then my second question on Europe.

Have you been engaging in conversations with with the.

Central partners and has there been a lot of interest and what's their biggest areas of pushback. Thanks, so much.

John Farrell: Thanks for the question. So regarding generics in the United States, you know, there's one new generic at this point in time. It came out at the beginning of November. We're seeing it in various respects. For example, patients are sometimes calling us to complain that the cost of the generic is higher than what they were paying for the branded product. We're seeing it from various managed care companies that have been interacting with us, recognizing that generic is costing them more on a net basis, and that's driven, in some cases, to improve managed care coverage.

Thanks for the question so.

Regarding generics in the United States.

The one launch generic at this point in time it came out of the beginning of the.

November.

Where we're seeing it in various respects, we're seeing it from.

Moving it from patients, sometimes calling up the complain that the cost of the generic is higher than what they were paying for the for the branded price we're seeing it from various managed care companies that have.

But the interacting with us recognizing that the generic because of course no more on a net basis.

That's driven in some cases to the approved.

Managed care coverage.

Most physicians are not highly aware of the.

John Farrell: Most physicians are not highly aware of the generic that's out there, and as you can see through our litigation, we have seen activity that we think is inappropriate by the generic company and, you know, at least by certain pay payers that, you know, we think creates a great situation where they're trying to go beyond the approved label for that product. But right now, they are self-described as being limited by supply.

Generic.

Out there.

And as you can see through our litigation we have seen.

Sure.

We have seen activity that we think is inappropriate bye.

But of the generic company.

At least by certain payers.

Payers that.

Great.

The credit situation, where they're trying to go beyond the approved.

<unk> for that product.

Now they are.

Self described as being limited by.

Limited by supply.

John Farrell: There have been outages at various pharmacies, which has also caused some complaints by patients where the patients are going to get their script filled, the pharmacist looks, oh, they're using the generic here, tried to get it, can't get it, sends the patient away, I'll try to get it and then still can't get it, and that's frustrating to patients.

There have been having the outages.

<unk> pharmacies, where because of also closed some complaints by patients where the patients are going to get the script filled the.

Pharmacist look all of them.

Use of the generic price to get it can't get it in the sense of patient of way I'll try to get it and then still can't get it and that's frustrating to.

Frustrating to pay.

Patients. So yeah. There is there is learning.

John Farrell: And, you know, we're, of course, trying to make sure that all parties involved, you know, whether it be payers, physicians, you know, patients, pharmacists, are aware of the, you know, skinny label of the generic, the fact that the pricing of the branded product is often less on a net basis than the generic product, and the risk of outages relative to the branded product. All while, you know, trying to introduce the product as deep into the market as the awareness of the product is still pretty low. It just launched 13 months ago, and much of that launch was during the flu pandemic.

Im going on.

We're of course trying to make sure that all parties involved up whether it would be payers physicians.

<unk> pharmacists are aware of.

The <unk> is.

In the label of the generic the fact of the pricing of the.

Branded product, we offer them the lesson of net basis than the.

Other than the generic product.

And you know the risks out of the news relative to the.

To the branded.

Product all while trying to introduce.

But to the market as the awareness of the <unk>.

<unk> is still pretty low interest launched 13 months ago and much of that launch was during a of theirs.

John Farrell: So, you know, we see there is significant educational need and opportunity out there. With regard to Europe and partners, The, I guess I'll approach your question in two ways. I'm not sure when you're referring to partners, whether you mean what we've gone through in the past or what we might go through in the future. In terms of going through the past, we did, before deciding to go for a self-launch in Europe, review partnering opportunities with larger companies in Europe, and we found interest in that, but we also convinced ourselves that the enormity of the opportunity in Europe justified an investment of our own to create the required infrastructure in Europe, and that we know the product best, and that we have a lot of experience with the product in the United States, Canada, for example, So we've gone through that previously and described that process, you know.

It's been during the pandemic.

You can see there is a significant educational need an opportunity out there with regard to Europe and partners.

The.

I guess I'll I'll approach your question in two ways, but I'm not sure what youre referring to partners.

Whether you mean sort of the what we've gone through in the past or what we might be going through.

Of the future in terms of going through in the past we did before.

<unk> to go for a self launch in Europe review.

Partnering opportunities with larger companies in Europe, and we've found interest from that but we also convinced ourselves of the enormity of the opportunity in Europe.

Justify a investment out of our own and create the.

The required infrastructure in Europe, and that we know the product.

<unk>.

And we have a lot of experience with the product in the United States and Canada for example on reimbursement in the.

Approaching of this ourselves was.

We'll provide greater upside value to our shareholders the.

Partnering at all of two.

Some larger company.

So we've gone through that previously and describe that process.

So perhaps youre, referring to the fact that we've talked about Europe as being sort of free.

John Farrell: So perhaps you're referring to the fact that we've talked about Europe as being sort of three levels of countries, right? So there's a large country, there's a mid-sized country, and then there's a smaller country. And, you know, in smaller countries, it is true that it probably does not make as much sense for Amarin to create infrastructure there when there are, you know, local companies that can do that, you know, potentially better than we can.

The levels of countries right, so there's a bit.

The large countries or the midsized trees, and then there's a smaller countries.

Smaller countries. It is true that it probably does not make as much sense for amarin to create infrastructure, there where there are local companies that can do that.

Potentially better than we can.

John Farrell: You know, we have been doing some planning and thinking in that area, but, you know, the biggest markets are, you know, the EU, you know, five, you know, starting with Germany. And, you know, most of our attention has been on getting ready for approval and preparing for market access, you know, reimbursement negotiations in the big five and in some of the sort of medium-sized countries. So we'll have more to say relative to partnering in the smaller countries after we get approval and go on a little bit further. But first and foremost, we need to be successful in the larger countries. So, hopefully, those comments were helpful.

We have been doing some planning and thinking in that area, but the.

The biggest markets or the EU.

Starting with Germany.

So most of our attention has been on getting ready for approval and preparing for market access reimbursement negotiations and the.

And the big five and in some of the sort of the medium sized countries. So we'll have more to say relative to the partnering in the smaller countries.

As you know after we get approval and get all of what further but the first and foremost we need to be successful in the.

And the larger countries. So hopefully those comments are helpful.

Thank you very much.

John Farrell: Thank you very much.

Okay.

Operator: Thank you, and the next question is coming from Jessica Fye. Jessica, your line is live. Please announce your affiliation and pose your question. Hey there, good morning. It's Jess Fye from J.P. Morgan. I was curious what you think of as some good price analogs for China.

Thank you and the next question is coming from Jessica Fye Jessica of your line of sight. Please announce your affiliation and pose your question.

Hey, there good morning, Jess Fye from JP Morgan.

What do you think of it some good price of analogs for China.

Jessica Macomber Fye: Transcription by Trans-Expert at Fiverr.com

Good morning Jess.

John Farrell: Good morning, Jess. First, we see what the label is going to be like in China. We're certainly pleased with the recommendation, you know, coming out of the Medical Society in China recommending the use of fentanyl for addressing cardiovascular risk reduction. But let's see what the Chinese FDA has to do relative to the label, you know, first. And then, you know, China is a complex market with reimbursement that can be very different from province to province, and then there's cash sales and reimbursed sales, and it really is the domain of our partner Edding, and one of the reasons why we picked Edding is that they're really good at this type of thing.

Firstly the.

See what the label is going to be in China. We were certainly pleased with the.

Recommendation coming out of the medical society in China of recommending the use of both by vessel or addressing cardiovascular risk reduction.

But let's see what the.

John.

Let me try the FDA has to do relative to the to the label Hilde first.

And then China as the.

The complex markets.

Of.

With reimbursement of that can be very different from province to province.

And then there is.

Cash sales and reimburse sales is and.

It really is the domain or our partner, adding in one of the reasons why we picked setting us up there really good of this type of thing so interest.

John Farrell: So it's just, I think, early for us to be setting a price, and I don't want to step on the toes of Edding. This is their domain. This is why we selected them as a partner. So it's a bit premature for us to provide an analog.

Think of early for us to.

Resetting of price in the end.

I don't want to step on the toes of adding this as this is their domain. This is why we.

Selected them as a partner so.

The premature for us the provider analogs of at this point.

Operator: Okay, thank you. Thank you. And the next question is coming from Joel Beasy. Joel, your line is live. Please announce your affiliation and ask your question.

Okay. Thank you.

Thank you and the next question is coming from Joel <unk>. Your line of life. Please announce your affiliation and pose your question.

Joel Beasy: Hi, this is Joel Beattie from Citi. Congratulations on the progress. The first question is, are there any examples of analogs in Europe in terms of the trajectory of the launch and how to think about drugs launching into large market indications there? And then the second question is, for the US, could you characterize the current level of awareness of SIPA and how changes in awareness can impact sales? Thanks.

Hi, This is Toby the from city congrats on the progress. The first question is.

Are there any examples of analogs in Europe in terms of the trajectory of the launch.

How to think about drugs launching into a large market indications there.

And then the second question is part of the U S. Could you characterize the current level of awareness of Vascepa and how changes in the awareness can impact sales.

John Farrell: Uh, Joel, good morning. Um...

Total good morning.

Relative to analogs per year.

John Farrell: Relative to analogs for Europe, you know, that's one that we have studied and studied and studied, you know, uh, you know, and, and you're really there. I can't, we have not found any product that, you know, has launched with outcomes data, no direct competition for a patient population of this size. There just isn't a good analog.

The one that we have.

Study the study the study.

Uh huh.

And you really there.

I can't we have not found any product that has.

Launch with outcomes no direct competition form of.

A patient population of this stock price.

There just.

Isn't so good.

The analog Gov we.

John Farrell: We have seen products with lesser results do quite well in Europe, but I think we need to first get approval and then get into the market. You know, the market access side of things and, you know, in there, I think we're going to try to be, you know, thoughtful, not biggish, but the aim is to try to help as many people as possible, but I think it's premature for us to, you know, really, predict an analog at this point.

We have seen products.

The.

What's our results do quite well in Europe, but I think we need the first get approval and then get into the.

The market.

The market access side of things.

There I think where prime is going to try to be.

Thoughtful of figures.

The biggest was the aim to try to help as many people.

Yes.

As possible by but I think it's premature for us.

Early.

And the analog against this.

At this point.

John Farrell: You know, I, you know, the With regard to the United States and awareness, you know, we've done some market survey work there, and Aaron Berg, who runs that side of things, is with us. And Aaron, maybe you can cite some of our recent awareness survey data and your sense of where the market is relative from an awareness perspective. Sure.

Yeah.

The.

So the.

<unk>.

With regard to the United States and awareness.

Done some.

So market survey work there and.

Aaron Berg, who runs that side of things is with us and Theyre Aaron maybe you can say some of our recent awareness.

Survey.

And the.

And your sense of where the market is relative.

Aaron D. Berg: Overall, unaided awareness of the SIPA is very low because we just launched the indication right before the pandemic. We had just expanded the sales force. We significantly expanded our target audience of HCPs, and then we essentially shut down, as did most of the industry. So we never got that off the ground, and CHIMI had the ability to build that awareness. And, of course, without awareness, you're not going to get understanding and prescriptions. And that's where it starts.

From an awareness perspective, the chore, but overall unaided awareness of Vascepa is very level, we just launched the <unk>.

The indication right before the pandemic, we had just expanded the sales force we significantly expanded our target.

Audience of Hcp's, and then essentially shut down most of the industry. So we never got that all of the ground.

Two we have the ability to.

To build that awareness and of course without awareness youre not going to get understanding and prescriptions.

That's where it starts we started to see recovery.

Aaron D. Berg: We started to see recovery through the summer, and we were getting more physicians and the sales force back out there and started to build more. But then again, as you headed into Q4, there was a significant resurgence, and it dampened promotional efforts as well. So our awareness overall from an HCP perspective is low, and even more so with consumers. In fact, even though we ran the campaign, awareness stayed in the teens through the second half of 2020.

Through the summer as we were getting the more physicians of the sales force back out there and starting to build more of a is that again then as you headed into Q4, there was the significant resurgence of dampen the promotional efforts.

As well so our awareness overall from an 18 18, HCP perspective is low and even more so with the consumers in fact, even though we ran the campaign the awareness and the teams through the second half of 'twenty 'twenty. So.

Aaron D. Berg: So we've got a lot of opportunity, and we're still a very small brand. Overall, we hope as we head into the recovery year, which we're all optimistic about, our promotional efforts will take hold. Patients will return to physicians, and the cycle will begin, and we'll see growth as a result of that.

We've got a lot of opportunity is still very small brands overall, we hope as we head into the recovery here as we're all optimistic about our promotional efforts will take hold of patients will return to physicians and the cycle will begin and then we'll see that growth is the result of that but it does start with words.

Aaron D. Berg: But it does start with awareness. And on the Europe piece, just one other comment.

Just saw the Europe piece of one one other comment.

John Farrell: I remind people, because there have been some media articles recently that have maybe taken this out of context, that we are not in Europe going after every single patient that has elevated triglycerides. What we're going after are patients who, despite cholesterol management, particularly statins, continue to have cardiovascular risk. So we're not trying to replace statins.

I would remind people because there's been some media articles recently that of.

Maybe taking us out of context, where nine year of going after every single patient.

Has elevated triglycerides, but we're going after of patients who.

Despite cholesterol management, particularly stat and continue to have cardiovascular risk. So we're not trying to replace statin statin soon.

It is a substantial market, but it is not the let's say the 8 million patient market that has shown up recently in some.

John Farrell: And it is a substantial market. But it's not the, let's say, 8 million patient market that has shown up recently in some media articles. And we do provide some market statistics in our 10K filing today that are consistent with what we talked about in the past. But I just wanted to, in light of some recent media pieces, emphasize that it's not every patient with elevated triglycerides that we're going after in Europe.

The media articles.

We do provide some.

The.

Market statistics in our 10-K filing today.

Consistent with what we've talked about in the past, but I just wanted the in light of some recent.

The pieces emphasize that it's not every patient with elevated triglycerides of but we're going after growth.

In Europe some of them.

John Farrell: I appreciate the interesting questions. We've taken an hour, an hour here. I know everybody's got to get on to other things. We're, we're presenting tomorrow at the Learning Conference Cowen, you know, next week. I thank you all for your support and interest and look forward to providing updates here as we continue to progress. Thanks, everybody. Have a great day.

Aye.

Appreciate the interest and questions we've taken an hour.

Sure here I know everybody has got to go on to other things.

We're.

We're presenting tomorrow.

The other.

The Leerink conference.

Now in the next week I'm sure there will be additional questions. There I. Thank you all for your support and interest and look forward to providing updates here as we continue the progress thanks, everybody have a great day.

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

Operator: Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time. Have a wonderful day. Thank you for your participation.