Q4 2019 Earnings Call

Lisa M. DeFrancesco: This conference call is being recorded today, February 25, 2020. I would now like to turn the conference call over to Elizabeth Schwartz, Senior Director, Investor Relations, of Amarin. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of the SIPA prescription. The SEPA product and licensing revenues, costs, and other commercial metrics, gross margin, expenditures, such as for the purchase of additional supplies of the SEPA, and the adequacy of our financial resources.

This conference call is being recorded today February 20, Fiveth 2020.

I would now let's turn the conference call over to Elizabeth Swartz Senior Director Investor Relations Cameron.

Please be aware this conference call will contain forward looking statements that are intended to be covered under the safe Harbor about about a private securities litigation.

Exams such statements include but are not limited to our current expectations regarding our commercial and financial performance, including levels at the steep a prescription.

People products and licensing revenues cost another commercial metrics gross margin expenditures such as for the purchase of additional supply the c., but I mean adequacy of our financial resources.

Lisa M. DeFrancesco: Our current expectations for additional scientific presentations, publications, medical guidelines, and regulatory reviews outside the United States and related timing thereof. Our plans and preparation for expanded promotion of the SIPA and related market positioning and potential, including the potential for further product development. Our goals regarding the timing, scope, and success of international expansion, our current plans for Salesforce and other commercial expansion in the United States, and our current expectations regarding the outcome of litigation pertaining to FISA exclusivity in the United States. These statements are based on information available to us today, February 25, 2020. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. The actual results or events could differ materially, so you should not place too much reliance on these statements. We assume no obligation to update these statements as circumstances change.

Our current expectations for additional scientific presentations publications medical guidelines and regulatory reviews outside the United States It related timing Dara.

Our plan and preparation for expanded promotion of the E Bay Adelaide market positioning of potential including the potential for further product development.

Our goal regarding the timing scope and success of international expansion I personally am for Salesforce and other commercial expansion in the United States and our current expectations regarding the outcome of litigation pertaining to other people exposed to it and I state.

These statements are based on information available to US today February 20 pass Twentytwenty. They may not actually achieved our goal carry out or plans retention or meet expectations disclosed in our forward looking statements actual always torture events could differ materially. So you should not place undue reliance on these statements leads you no obligation to update.

These statements that circumstances change a forward looking statements do not reflect the potential impact a significant transactions may enter into such as mergers acquisitions dispositions joint ventures or any material agreements that we may enter into let attorney for additional information concerning factors that could cause actual results to differ materially. Please a forward looking state.

Lisa M. DeFrancesco: Our forward-looking statements do not reflect the potential impact of significant transactions. For additional information concerning the factors that could cause actual results to differ materially, please see the Forward-Looking Statements section in today's press release and the Risk Factors section of our annual report on Form 10-K for the year ended December 31, 2019. These documents have been filed with the SEC and are available through the Investor Relations section of our website at www.amarincorp.com. We encourage everyone to read these documents. The call is intended for investors in Amarin and is not intended to promote use of SIPA outside its approved indication. Please note that we are also providing slides to accompany today's call. These slides, which can be found on our website, www.amarincorp.com, in the Investor Relations section under the subcategory Events and Presentations I will summarize some of the key updates discussed on today's call. Finally, an archive of this call will be posted on the Amarin website, also in the Investor Relations section. I'll now turn the call over to John Theroux, President and Chief Executive Officer of Amarin. Hello everybody.

Section of today's press release, and the risk factor section of our annual report on form 10-K C. You're right at December 31st 2019.

Documents have been filed with the FCC are available for the Investor Relations section of our website at <unk> Dot com encourage everyone to meet these documents, it's called intended for investors an ever and it's not I'm trying to promote the heat the outside its approved indication. Please not that we're also providing slides to accompany today's call. These slides, which can be found.

At our website <unk> dot com and the Investor Relations section under.

Yes, I category I thought the presentation summarize some of the key updates discussed on today's call. Finally, an archive of this call will be posted on the Amarin website also an investor Relations section I'll now turn the call over to John Thero, President and Chief Executive Officer camera.

Hello, everybody.

John Theroux: Thanks for joining us today. During this call, we will recap our 2019 results, which were quite positive, and provide some insights into our 2020 priorities and early 2020 progress. After our prepared comments, we will respond to questions. Some of you sent questions in advance.

Thanks for joining us today during this call we will recap our 2019 results, which were quite positive and provide some insights into our 2025 priorities and early 2020 progress.

After our prepared comments, we will respond to questions.

Some of you send questions in advance we attempted to address many of those questions in our prepared comments.

John Theroux: We attempted to address many of those questions in our prepared comments. It is an exciting and busy time for Amarin. We are enthusiastic and encouraged by the progress we are making and by the feedback we are hearing from healthcare professionals regarding Visepa and its now expanded role in improving patient care. Amarin's results in 2019 position us well for the future. In 2019, we received FDA approval of VACIPA for a broad and new cardiovascular risk reduction indication pursuant to the completion of our seven-year REDUCE-IT outcome study and following a unanimous 16-0 ADCOM vote. Unanimous ADCOMM votes are uncommon, and this vote reflects the robust and consistent clinical results demonstrated by Visepa, with clinical benefits that clearly outweighed risks for patients needing this paradigm-shifting therapy. We realized an 87% Typically, an 87% increase in revenues would be the first on a list of achievements.

[laughter] is exciting and busy time Rambler, we're enthusiastic and encouraged by the progress, we're making and by the feedback we're hearing from health care professionals regarding the seat, but it has now expanded role and improving patient care.

Amarins results in 2019 position us well for the future.

In 2019, we received FDA approval of a SEPA for abroad, and new cardiovascular risk reduction indication pursuant to the completion of our seven year reduce it outcome study and following a unanimous 16 to zero AD com vote.

Unanimous Ed combos or uncommon and this vote reflects the robust inconsistent clinical results demonstrated by the seat.

Clinical benefits, which clearly outweighed risks for patients meeting this paradigm shifting therapy.

Realized it 87% increase in revenue over 2018 predominantly through increased volume of but SEPA sold the United States, reflecting growth in normalized prescriptions overseas.

Differently and 87% increase in revenues would be the first I'll list of achievements.

John Theroux: For 2019, this growth is eclipsed by the enormity of the importance to patient care and to Amarin of the FDA's approval of the Expanded Indication for Visepa. In addition, we contributed to the issuance of 57 scientific publications and presentations. Supported our Canadian partners' approval to market Visepa in Canada, filed for approval to market SIPA in Europe and had that filing accepted for review as a centralized filing by the European Medicines Agency, hired and on-boarded hundreds of sales representatives to broaden our sales reach while further bolstering our sales management, and observed Vasepa becoming recognized as a new treatment option for cardiovascular risk reduction by eight major medical societies. Such recognition includes reference to Visepa clinical trial results not being generalizable to any product other than Visepa, and witnessed multiple pharmacoeconomic analyses conclude that the SEPA is cost-effective, including an analysis from MedStar reporting that in most scenarios, the use of a SEPA should save money for society by helping reduce the occurrence of high-cost cardiovascular events such as stroke and heart attack. I could cite many additional Amarin accomplishments in Clearly, 2019 was an outstanding year of execution and results. We are now focused on the success of the commercial launch of SIPA for its new indication. Accordingly, let's shift our discussion to 2020.

For 2019 this growth is eclipsed by the enormity of the importance to patient care and <unk> Amarin, Oh, the F.D.A. approval of the expanded indication for Vascepa.

In addition, we contributed to the issue, it's a 57 scientific publications and presentations.

Supported our Canadian partners approval to market, the c., but in Canada.

Filed for approval to market the seat, but in Europe and had that's part of any accepted for review as they centralize filing by the European Medicines Agency.

Hi, your non boarded hundreds of sales representatives to broaden our sales reach while further bolstering our sales management.

Observe a SEPA, becoming recognized as a new treatment option for cardiovascular risk reduction by eight major medical societies.

Such recognition includes reference to the Super clinical trial results not being generalizable to any products other than placebo.

And witnessed multiple pharmacoeconomic analyses concluded that the SEPA is cost effective.

Including an analysis for Medstar reporting that in most scenarios the use of the SEPA should save money for society by helping reduce the occurrence of high cost cardiovascular events, such as stroke and heart attacks.

I could say, many additional amarin accomplishments and Johnny 19.

Clearly 2019 was an outstanding year of execution and results.

We're now focused on the success of the commercial launch of a SEPA for its new indication.

Accordingly, let's shift our discussion to Twentytwenty.

John Theroux: FACEPA represents a new class of proven preventative therapy. Vasepa is the first and only drug with this new cardiovascular risk reduction indication. Our launch of VACIPA for this new indication reflects the uniqueness of VACIPA. Such uniqueness is magnified by a backdrop in which all potential competitors that completed or terminated cardiovascular outcome studies have failed to demonstrate that the benefits of their products exceed the risks of such products.

The Super represents a new class a proven preventative therapy.

<unk> is the first and only drug with this new cardiovascular risk reduction indication.

Our launch a bus SEPA for this new indication reflects the uniqueness of placebo so.

So its uniqueness is magnified by backdrop in which all potential competitors that completed or terminated cardiovascular outcome studies have failed to demonstrate that the benefits of their products exceed the risks of such products.

John Theroux: Of course, we are pleased that the FDA approved Visepa for this new indication, and we are pleased that the new label for Vasepa provides significant discretion to healthcare professionals regarding which at-risk patients should be treated with Vasepa. It is further gratifying that the FDA, immediately after approval of Vasepa in December as the first and only drug for this new indication, issued a press release pertaining to this approval in which it was stated, Today's approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke, and diabetes, an adjunctive treatment option that can help decrease their risks of cardiovascular events. Not every FDA approval results in a The demonstrated benefit of using Visepa is tremendous and robust.

Of course, we're pleased that the FDA approved the SEPA for this new indication.

And we are pleased that the new label purpose SEPA provide significant discretion to health care professionals regarding which at risk patients should be treated with the SEPA.

It is further gratified that the FDA immediately after approval, but see but in December as the first and only drug for this new indication issued a press release pertaining to this approval in which it was stated.

Today's approval, we'll give patients with elevated triglycerides and other important risk factors, including heart disease stroke, and diabetes and I'd jump.

Treatment option that can help decrease their risks of cardiovascular events.

Not every after FDA approval results and a corresponding F.D.A. issued press release.

The demonstrated benefit of using but SEPA is tremendous and robust.

John Theroux: Our commercial launch of Visepa emphasizes education of healthcare professionals regarding these benefits and includes focusing on securing affordable access to managed care for all patients who can benefit from Visepa. Thus far, our launch of a SIPA for this expanded indication is progressing as planned. We are hearing positive feedback regarding BASIPA from physicians, pharmacists, and other healthcare professionals while witnessing some early positive examples of further improvements to managed care coverage. Our messaging reflects that existing treatments, such as statins, are helpful, but they don't do enough. Statins have been shown to lower cardiovascular risk by approximately 25-35%.

Our commercial launch of a SEPA emphasizes education and health care professionals regarding these benefits and includes focus on securing affordable access for managed care for all patients who can benefit from the SEPA.

Thus far our launch of a steep up for this expanded indication is progressing as planned.

We are hearing positive feedback regarding but keep up from physicians pharmacists and other health care professionals, while witnessing some early positive examples of further improvements to managed care coverage.

Our messaging reflects that existing therapy, such as stands are helpful. But they don't do enough.

Studies have been shown to lower cardiovascular risk by approximately 25, 35%.

John Theroux: The FIPA has been shown to lower cardiovascular risk by another 25% beyond the risk reduction from statins. This is the largest risk reduction shown in addition to statin therapy. For example, azetamide and PCSK9 inhibitors have been demonstrated to have approximately 6% and 15% relative risk reductions, respectively, in statin-treated patients.

The SEPA has been shown to lower cardiovascular risk by another 25% beyond the risk reduction from status.

This is the largest risk reduction shown in addition to stand therapy.

For example.

Was that it might and Pcsknine inhibitors have demonstrated at approximately 6% and 15% relative risk reduction respectively. Instead untreated patients.

John Theroux: The SEPA provides a new treatment option and does not compete in the increasingly crowded field of LDL cholesterol management. We wish all such cholesterol-lowering products well in improving patient care. With Vasipa, we are addressing the unmet medical need for patient care beyond cholesterol management. Strong scientific knowledge and evaluation have led us to clinical success with the sequence. We intend to continue to be active at medical congresses and other scientific forums in 2020, and such activity will include further presentation of detailed results of the reduced study.

The SEPA provides a new treatment option.

And does not compete in the increasingly crowded field of LDL cholesterol management.

We wish all such cholesterol lowering products, well and improving patient care.

With the SEPA, we are addressing the unmet medical need a patient care beyond cholesterol management.

Strong scientific knowledge and evaluation has led us to clinical success with the SEPA.

We intend to 2022 continued to be active and medical Congresses and other scientific forums.

Such activity will include further presentation of detailed results over the reduce it study.

John Theroux: For example, at the upcoming 2020 Annual Scientific Sessions of the American College of Cardiology, scheduled for late March, eight Amarin-sponsored scientific presentations related to basica or persistent cardiovascular risk have been accepted. This includes one presentation on VASIPA that has been accepted as a late breaker. In conjunction with this medical conference, we plan to webcast comments from many of these presenters regarding their findings. Details regarding that webcast will be made available in March as we get closer to that conference. In parallel with such presentations of new data at scientific forums, we are also sponsoring various forms of medical education regarding vasectomy, and the Principal Investigator for the REDUCED Study remains active in giving invited lectures, also known as Grand Rounds, at leading medical institutions regarding the unprecedented results of the REDUCED Study.

For example at the upcoming 2020 annual scientific sessions over the American College of Cardiology scheduled for late March eight amarin sponsored scientific presentations related to the steep up or persistent cardiovascular risk had been accepted.

This includes one presentation on but SEPA that has been accepted as a late breaker.

In conjunction with this medical conference we plan to webcast comments for many of these presenters regarding their findings.

Details regarding that webcast will we made in March as we get closer to that conference.

In parallel with such presentations, a new data at scientific forums, where also sponsoring various forms of medical education regarding the seat.

And the principal investigator for the reduces study remains active in making invited lectures also knows grand rounds at leading medical institutions regarding the unprecedented results of the reduced study.

John Theroux: Unfortunately, many healthcare professionals do not have the opportunity to attend all scientific forums. Accordingly, we are increasing our promotion of Visepa via multidimensional commercial means. Including outreach to our sales force, via direct electronic means, and various forms of advertising. Regarding our sales force in the United States, we are now close to doubling its size. As previously described, we believe that a U.S. sales force of 800 sales representatives, supported by our other promotional activities, is positioned to make Visepa a multi-billion dollar brand. Our sales team enthusiastically believes this as well. We hired and trained new sales representatives in waves during December, January, and February. At this point, nearly all of the targeted 800 sales representative positions have been filled. A small number of newly hired sales representatives are still undergoing training, but they should be in the field soon. As is the nature of hiring, some people don't succeed and need to be replaced.

Unfortunately, many healthcare professionals do not have the opportunity to attend all scientific forums.

Accordingly, we are increasing our promotion of vascepa, the multi dimensional commercial means including outreach through our salesforce direct electronic means and various forms of advertisement.

Regarding our salesforce in the United States.

We're now close to doubling in size.

As previously described we believe that a U.S. salesforce of 800 sales representatives supported by or other promotional activities.

His position to make but see but a multi billion dollar brand.

Our sales team enthusiastically believes this as well.

We hired and trained new sales representatives in waves during December January and February.

At this point nearly all of the targeted at 800 sales representative positions have been built.

A small number of newly hired sales representatives are still undergoing training.

They should be in the field soon.

As is the nature of hiring some people don't succeed and need to be replaced.

John Theroux: Overall, we are impressed with the attitudes, intelligence, passion, and experience of the members of our sales team. We did not wait for all of our new sales representatives to be hired before commencing the launch of SIPA in the United States for its new indication. In early January, we conducted sales training for our new sales representatives regarding promotional materials and messaging for Visepa. However, it is too early in the launch to judge the progress of our newly hired sales representatives or the progress of our sales launch. It typically takes the better part of a year for new sales representatives to become highly productive.

Overall, we are impressed with the attitudes intelligence passion and experience of the members of our sales team.

We did not wait for all of our news sales representatives to be hired before commencing the launch of a c., but in the United States for its new indication.

In early January we conducted sales training for our new sales representatives regarding promotional materials and messaging services.

It is too early in the launch to judge the progress of our newly hired sales representatives or the progress of our sales launch.

It typically takes the better part of a year for new sales representatives to become highly productive.

John Theroux: Although with Visepa, it is possible that this may occur faster. We are hearing many positive anecdotes from both our recently hired and our more tenured sales representatives. Many of these anecdotes relate to physicians to whom we did not directly promote ZIPA previously and who are now aware of VASFIPA's unprecedented clinical results. Other anecdotes come from prior prescribers of Visepa, who comment that their patients are responding and are more receptive to taking Bacepa pursuant to FDA approval. As an aside, doctors are impressed with the breadth of the FDA-approved label for vasectomy. They like that the language in the label reflects medical terminology that they use in their practice every day, such as established cardiovascular disease, rather than definitions used for clinical trial purposes. Many doctors have expressed to us that they believe that they can help many patients with this label. They appreciate that the label doesn't reference fasting or non-fasting triglycerides, that it doesn't set any required target for the management of LDL cholesterol, and it does not distinguish between type 1 and type 2 diabetic patients.

Although with the SEPA it is possible, but this may occur faster.

We are hearing many positive anecdotes from both our recently hired in a more tenured sales representatives manage these anecdotes relate to physicians to whom we didn't not directly promote fuzzy but previously.

And who are now aware of as steep as unprecedented clinical results.

Other anecdotes come from prior prescribers have been SEPA.

Common that their patients are responding and are more receptive to taking the SEPA pursuant to the FDA approval.

As an aside doctors are impressed with the breadth of the FDA approved label purpose SEPA.

They like that the language and the label reflects medical terminology, which they use in their practice everyday such as establish cardiovascular disease.

Rather than the definitions use for clinical trial purposes.

Many doctors have expressed to us that they believe that they can help many patients with this label.

[noise]. They appreciate the label doesn't reference fasting or non fasting triglycerides that it doesn't set any required target for management of LDL cholesterol and it does not distinguish between type one and type two diabetic patients.

John Theroux: This past weekend, we completed training for select positions who will conduct peer-to-peer programs regarding the SIPA. It was thrilling to see the excitement and energy that these doctors are bringing to our educational efforts across most of the United States. Many doctors wanted to be part of this program.

This past weekend, we completed training for select positions, who will conduct peer to peer programs regarding the SEPA.

It was thrilling to see the excitement and energy that these doctors are bringing to our educational efforts across most the United States.

Many doctors wanting to be part of this program.

John Theroux: Unfortunately, we were limited in the number of doctors we could invite.

And Fortunately we were limited regarding the number of doctors we can invite.

John Theroux: Throughout the meeting, I repeatedly heard these physicians referring to that they take Fazepa themselves and that they are proud to prescribe it for their patients. They ranked the reduced study results with the results of 4S, the study which made statin therapy a standard of care, as the two most important clinical studies conducted in the modern era regarding preventative cardiovascular care. Unless you're a health care professional, you won't see these speaker programs, and you won't see electronic communications sent to health care professionals regarding BCIPA. However, many of you have commented that you have recently seen that we began promotion of Bicepa on television. In addition, a month ago, we launched a campaign featuring unbranded TV spots that are intended to raise awareness of the persistent risk that exists beyond maximally tolerated statin therapy. The campaign reminds viewers that earlier generation therapies have not been shown to be effective in addressing such risks. There are, for example, roughly five times as many patients being treated with Fibrate than with SIPA. This imbalance may have been easier to justify before successful reduced results.

Throughout the meeting I repeatedly heard these positions referring to that they take busy for themselves and that they are proud to prescribe it for their patients.

They ranked the reduces study results was the result of four Ras the study, which made Staten therapy as standard of care as the two most important clinical studies conducted in the modern era regarding preventative cardiovascular care.

Unless you're a healthcare professional you won't see these speaker programs and you won't see electronic communication sent to health care professionals regarding proceed but.

However, many of you commented that you recently seen that we began promotional placebo on television.

In addition, a month ago, we launched a campaign featuring unbranded TV spots that are intended to raise awareness of the persistent risk that exists beyond maximally tolerated statin therapy.

The campaign reminds viewers that earlier generation therapies have not been shown to be effective in addressing such risk.

There are for example, roughly five times as many patients being treated with Fibrates then with the SEPA.

This imbalance may have been easier to justify before successful reduce the results.

John Theroux: However, today, given the failure of phenol fibrates to demonstrate cardiovascular benefit and the success of Vasifa, we seek to remind healthcare professionals and consumers that they should look beyond phenol fibrates and other earlier-generation products for proven effective therapy. The same is true regarding products consisting of omega-3 mixtures, all of which have failed on top of statin therapy to demonstrate cardiovascular benefit, including multiple failed studies in the past two years. When I say that our new TV ad campaign is unbranded, that means that it does not mention Basifa by name.

However, today, given the failure pheno fibrates to demonstrate cardiovascular benefit and the success of a seat, but we seek to remind health care professionals and consumers that they should look beyond you know fibrates and other earlier generation products for proven effective.

Therapy.

The same is true regarding products consisting of a mega three mixtures all of which fail on top of statin therapy to demonstrate cardiovascular benefit including multiple failed studies in the past two years.

When I say that our new TV AD campaign is unbranded that means that does not mention for SEPA by name.

John Theroux: An unbranded TV ad can be more easily launched without FDA promotional review. Additionally, separately, for future use, we have developed a targeted television promotion that names Visepa and ties Visepa directly to its cardiovascular risk reduction effect. The messaging from such promotion is currently under review by the FDA's Office of Prescription Drug Promotion. We expect such review to be completed in time to support our launch of a branded direct-to-consumer

An unbranded TV, Ed can be more easily launched without ft, a promotional review.

Separately for future use we have developed targeted television promotion that means for SEPA and ties the SEPA directly to its cardiovascular risk reduction effects.

The messaging from such promotion is currently under review by the FDA office of prescription drug promotion.

We expect such review to be completed in time to support our launch a branded direct to consumer advertisement in mid 2020.

John Theroux: At that time, with advertising that both references VASIPA by name and refers to lowering cardiovascular risk, we intend to increase the frequency of our advertising. We anticipate that branded direct-to-consumer promotion will be a significant factor in raising Bicepa awareness among people who might benefit from Bicepa and healthcare professionals who are not otherwise called upon by Amarin's sales team, while we anticipate meaningful growth in PASIPA prescriptions prior to the launch of such branded consumer promotion. The DTC program is anticipated to provide further inflection upward in such prescription growth. Regarding managed care coverage for VASIPA, overall, the coverage is good. We are working to improve it.

At that time.

With advertising, which both references but SEPA by name.

And refers to lowering cardiovascular risk, we intend to increase the frequency of our advertising.

We anticipate that branded direct to consumer promotion will be a significant factor in raising buzz heap awareness among people who might benefit from the SEPA and health care professionals, who are not otherwise called upon by Amarin sales team.

While we anticipate meaningful growth empathy for prescriptions prior to launch of such branded consumer promotion.

The DTC program is anticipated to provide further inflection upward in such prescription growth.

Regarding managed care coverage for Vascepa overall the coverage is good.

We are working to improve it.

John Theroux: At the start of every year, there are changes in managed care coverage. Changes at the start of 2020 were, in aggregate, favorable. Managed care plans with expanded coverage for Bicepa exceeded those with restrictions. Such beginning-of-the-year coverage changes were decided by payers before FDA approval of the expanded label for Visepa in mid-December. Following FDA approval of the expanded label for Vasepa, our managed care team and our medical affairs team have been interacting with payers to ensure that they appreciate the clinical benefit of Vasepa, the FDA approval, the pharmacoeconomic analysis of FACIPA, and the guidelines of multiple medical societies which recommend the use of this drug without a substitute. In recent weeks, we have learned of more payers removing prior restrictions on VISIPA coverage, including Blue We are confident that additional payers will move to expand coverage of BCIPA. Some of this further improvement should occur because of our educational initiatives with payers and because it is the right thing to do.

At the start of every year there are changes in managed care coverage changes of the started 2020 were an aggregate favorable.

Managed care plans with expanded coverage for SEPA exceeded those with restrictions.

Such beginning of the year covered changes where decided by payers before after FDA approval of the expanded label for Vascepa in mid December.

Following FTC approval of the expanded label for placebo, our managed care team and our medical affairs team have been interacting with payers to ensure that they appreciate the clinical benefit of the SEPA.

The FDA approval, the Pharmacoeconomic analysis of the SEPA and the guidelines a multiple medical societies, which recommend use of this drug without substitute.

In recent weeks, we have learned a more payers removing prior restrictions to proceed but coverage, including Bluecross Blueshield plans of Michigan, North Carolina and Arkansas.

We are confident that additional payers will move to expand coverage of the SEPA.

Some of this further improvement should occur because of our educational initiatives with payers and because it is the right thing to do.

John Theroux: Some of this improvement is likely to occur because patients and physicians insist that this new class of preventative care therapy be broadly covered by insurance. The voices of physicians and patients are powerful in this regard. Insurance coverage for patients can be particularly tricky in the early part of a calendar year. This is due to beginning-of-the-year insurance deductibles that are part of the coverage provisions under various insurance plans. Such beginning-of-the-year deductibles are independent of insurance coverage for individual drugs. As discussed in prior years, these beginning-of-the-year deductibles often result in patients forgoing filling their prescriptions, creating a seasonal effect. As expected and as guided at the start of 2020, we are again seeing this impact this year. However, we are also seeing an increase in the number of new prescriptions to base and an increase in the number of physicians prescribing Vasepa. Such increases should continue to contribute to growth year over year.

Some of this improvement is likely to occur because patients and physicians insist that this new class a preventative care therapy be broadly covered by insurance.

The voices of physicians and patients are powerful in this regard.

[noise] insurance coverage for patients can be particularly tricky in the early part of a calendar year.

This is due to beginning of the year insurance deductibles that are part of the coverage provisions under various insurance plans.

Such beginning of the year deductibles are independent of insurance coverage for individual drugs.

As discussed in prior years. These beginning of the year deductibles often result in patients for going filling their prescriptions, creating a seasonal effect.

As expected and has guided the started 2020, we are again seeing this impact this year.

However, where you're also seeing an increase the number of new prescriptions to patients and increasing the number of physicians prescribing vascepa.

Such increases should continue to contribute to growth year over year.

The amount of patient is required to pay out of pocket for Vascepa is determined largely by the patients insurance plan and not amarin.

John Theroux: The amount a patient is required to pay out-of-pocket for Visepa is determined largely by the patient's insurance plan and not Amarin. The insurance plan decides whether the patient is subject to the deductible and the amount of the deductible. Most payers have this HIPAA covered on Tier 2, which is good. The amount of the deductible varies.

The insurance plan to size, whether the patient is subject to deductible and the amount of the deductible most payers have been SEPA covered on tier two which is good.

The amount of deductible berries.

John Theroux: Deductible amounts from non-government insurance can be offset by co-pay cards. Amarin continues to make copay cards broadly available for PASIPA. Recently it was announced that Epinova, the product that many people thought could become the strongest competition for Visepa. Heading Outcomes Study, Strength Trial Discontinued Early, F-ANOVA is an omega-3 mixture in free fatty acid form containing DHA and slightly over 50% EPA. While the details behind the termination of that study are not yet public, it appears clear that AstraZeneca won't be pursuing a cardiovascular risk reduction indication based on strength. Efanova joins a long list of products that failed cardiovascular outcome studies on top of statin therapy. Earlier examples include niacin, fibrase, DHA-containing prescriptions, and dietary supplements.

Deductible amounts from non government insurance can be offset by co pay cards Amarin continues to make co pay cards broadly available for Vascepa.

Recently, it was announced that Epanova the product that many people thought could become the strongest competition for the SEPA.

I had an outcome study.

The strength trial just continued early.

Epanova isn't Omega three mixture in free fatty acid form containing D.J. and slightly over 50% EPA.

While the details behind the termination of that study are not yet public.

It appears clear that Astra zeneca won't be pursuing a cardiovascular risk reduction indication based on strength.

Epanova joined a long list of products that failed cardiovascular outcome studies on top of Staten therapy.

Earlier examples include niacin, Fibrates, D.A.J. containing prescription and dietary supplement Omega threes.

John Theroux: Only pure, stable prescription bacepa is proven to reduce major adverse cardiovascular events in high-risk patients, and only Visepa is approved for this indication by the FDA. We look forward to learning more about the results of the STRENGTH trial. Data from that study may provide further helpful insights into differences in effects between EPA and DHA and between esterified fatty acids and free fatty acids. On the surface, the termination of such a study further supports that stable and pure EPA is unique and has multifactorial effects beyond triglyceride lowering, and adds further to the growing questions about ways in which DHA may offset the positive impact of EPA. It also raises questions about whether short-term testing of free fatty acids provides reliable information regarding effectiveness for chronic use compared to sterified fatty acids.

[noise] only pure stable prescription the SEPA is proven to reduce major adverse cardiovascular events in high risk patients and only been SEPA is proven for this indication by the FDA.

We look forward to learning more about the results of the strength trial.

Data from that study may provide further helpful insights into differences in effect between EPA and D.A. J.

And between a stair five fatty acids and free fatty acids.

On the surface the termination no such study further supports that stable and pure EPA is unique and has multifactorial opex beyond triglyceride lowering.

And it's further to the growing questions about ways in which DHL. They may offset the positive impact of EPA.

It also raises questions about weather short term testing of free fatty acids provides reliable information regarding effectiveness for chronic use compared to a stair five fatty acids.

John Theroux: These Differences in Uncertainty, together with the high bar established by proven cardiovascular risk reduction with SIPA, are likely to increase clinical research while heightening the multi-year testing requirements of potential future competitive products in this field. For avoidance of doubt, when I refer to pure and stable EPA, I am referring to icosapent ethyl marketed as VSEPA. The reference to stable is a reminder that EPA is fragile. It is easily damaged by, for example, heat, or degrades if exposed to oxygen.

These differences and uncertainties together with the high bar establish by proven cardiovascular risk reduction with the SEPA.

Are likely to increase clinical research why heightening, the multiyear testing requirements of potential future competitive products in this field.

For avoidance of doubt when I refer to pure and stable EPA I am referring to I coast depend Ethel marketed as the steep.

The referenced a stable is a reminder, that EPA is fragile.

It is easily damaged by for example heat.

Or degrades if exposed to oxygen.

John Theroux: The clinical effects of oxidized EPA are not proven to be effective; it is only pure and stable EPA in a sterified form as delivered by Bicepa that has been shown to be effective. Recently, the American Association of Clinical Endocrinologists added eclospinazole to their guidelines as a therapy to use if statins alone don't get patients' medical profiles to recommended levels. They join other medical societies with icosapent ethyl in their guidelines, such as the American Diabetes Association, European Society of Cardiology, and National Lipid Association. These medical societies and their guidelines appreciate that there is no current substitute for Bicepa to lower the risks of cardiovascular disease in approach to patients beyond statin therapy. In particular, the guidelines for these medical societies appreciate that triglyceride-lowering agents other than Vasepa have all failed to show outcomes supporting that the effects of Vasepa go uniquely beyond triglyceride-lowering.

The clinical effects oxidized EPA are not proven to be effective and is only pure and stable EPA and its terrified form as delivered by bus SEPA that has been shown to be effective.

Recently, the American Association of clinical Endocrinologists added a close basketball to their guidelines as a therapy to use of stands alone don't get patients medical profiles to recommended levels.

They join other medical societies without cost about Ethel and their guidelines such as the American Diabetes Association European Society of Cardiology, and National lift but association.

These medical societies and their guidelines I appreciate that there is no current substitute for the SEPA to lower the risk of cardiovascular disease and appropriate patients beyond stead therapy.

In particular the guidelines for these medical societies appreciate that.

Triglyceride lowering agents other than bus SEPA have all failed to show outcomes supporting that the effects of the c., but go uniquely beyond triglyceride lowering.

Internationally, we continue to work with our existing commercial partners in Canada, China, and the middle East to advance for SEPA.

John Theroux: Internationally, we continue to work with our existing commercial partners in Canada, China, and the Middle East to advance Visepa. Health Canada at the end of 2019 provided approval for our Canadian partner HLS Therapeutics to market and sell Visepa in Canada. HLS started selling Visepa very recently in what is likely to be a phased launch, starting with a core sales team and expanding from there.

Health, Canada at the end of 2019 provided approval to our Canadian partner HLS therapeutics to market and sell for SEPA in Canada.

HLS started selling but SEPA very recently and what is likely to be a phase launch starting with a core sales team and expanding from there.

John Theroux: Our partner in China, Edding Farm, is progressing with its clinical trial with anticipated completion before the end of 2020. We are told by people who are closest to that trial that they do not anticipate any delay in completion because of the coronavirus. The European Approval Process for the Cardiovascular Risk Reduction Indication for VCEPA is ongoing and so far has proceeded as expected. We submitted our European marketing application as a centralized filing to the European Medicines Agency, or EMA, and, as we announced at the start of December, it was accepted for review. The Day 120 letter from EMA, which contains questions and requests for additional information, is expected near the end of March 2020.

Our partner in China, Eddingpharm is progressing with its clinical trial with anticipated completion before the end of Twentytwenty.

We are told by people who are closest to that trial that they do not anticipate any delay in completion because of grown a virus.

The European approval process for cardiovascular risk reduction indication for Vascepa is ongoing and so far has proceeded as expected.

We submitted our European marketing application as a centralized filing to the European medicines agency or in May and as we announced at the start of December It was accepted for review.

The day 120 letter for me I may which contains questions and request for additional information is expected near the end of March 2020.

Similar to what was pursued improved in Canada, and Europe, we are seeking an indication for cardiovascular risk reduction.

John Theroux: Similar to what was pursued and approved in Canada, in Europe, we are seeking an indication for cardiovascular risk reduction. Our decision not to seek approval in Canada for triglyceride lowering has preserved the ten years of regulatory exclusivity available for a new product in Europe for use with the indication we are now seeking. We anticipate Patent Protection to extend beyond 10 years relating to FACEPA and cardiovascular risk reduction in Europe. While Amarin could launch Vasipa in Europe on its own, initial expressions of interest for European marketing rights to Vasipa have been robust from multiple established and capable commercial players. However, for reasons discussed in prior investor communication, we have been deferring more complete exploration of such interests.

Our decision to not seek approval in Canada for triglyceride lowering has preserved the 10 years, a regulatory exclusivity available for our new product in Europe for use with the indication we're now seeking.

We anticipate.

Patent protection to extend beyond 10 years relating to the SEPA in cardiovascular risk reduction in Europe.

Well amarin could launch the SEPA in Europe on its own initial expressions of interest for European marketing rights to proceed but have been robust from multiple established and capable commercial players.

However for reasons discuss than prior Investor Communications, we have been deferring more complete exploration of such interest.

John Theroux: If there are no surprises from the initial review by the European Medicines Agency, and with the early steps of our Visepa launch in the United States well underway, we intend at that time to increase our attention on commercialization opportunities for Visepa in Europe in preparation for our expectation that we will receive approval in late 2020 from the EMA to commence Visepa marketing and sales in Europe. The need for preventative cardiovascular care beyond currently available therapy is very large in Europe, as it is throughout the world. In Europe, there are more than 80 million people living with cardiovascular disease. This number is growing with approximately 11 million new cases of cardiovascular disease added each year in EU countries. CVD results in approximately 1.8 million deaths each year in Europe, on top of a large number of debilitating events such as strokes and heart attacks resulting from CVD.

If there are no surprises from the initial review by European Medicines Agency.

With the early steps of our received for launch in the United States well underway.

We intend at that time to increase our attention on commercialization opportunities for Vascepa in Europe in preparation for our expectation that we will receive approval in late 2020 from the in May to commence the SEPA marketing and sales in Europe.

The need for preventative cardiovascular care beyond currently available therapy is very large in Europe as it is throughout the world.

In Europe, there are more than 80 million people living with cardiovascular disease. This number is growing with approximately 11 million new cases of cardiovascular disease added each year in the EU countries.

Cardiovascular disease results in approximately 1.8 million deaths each year in Europe.

On top of large numbers of debilitating events, such as strokes and heart attacks, resulting from cardiovascular disease.

John Theroux: Caring for cardiovascular disease in Europe is expensive, with annual spending estimated to currently exceed €20 billion annually. These data, combined with clinical results with SIPA, likely contributed to the medical guidelines issued by the European Society of Cardiology and the European Atherosclerosis Society recommending the use of a co-spendathlon. Numerous key opinion leaders in Europe are urging for the approval of Bicepa in Europe to help them improve care for their patients.

Caring for cardiovascular disease in Europe is expensive with annual spending estimated the currently exceeds 20 billion euro annually.

These data combined with clinical results with the SEPA likely contributed to the medical guidelines issued by the European Society of Cardiology, and the European Atherosclerosis Society recommend to use because spend apple.

Numerous key opinion leaders in Europe, our urging for the approval of a steep in Europe to help them improve care for their patients.

John Theroux: With respect to Amarin's ongoing patent litigation with generic pharmaceutical companies, you are likely aware that the trial portion of the litigation was completed in late January. Post-trial briefs are expected to be publicly available on the court docket on February 28. As previously expressed, Amarin does not plan to provide commentary regarding details of this ongoing litigation. Based on court proceedings, the court's decision on this matter is expected near the end of March. Amarin's commercial plans assume that the courts uphold our patents and otherwise ensure that Amarin retains the exclusivity which we believe we deserve under the law. Such exclusivity will support Amarin's further promotion and education, leading to expanded use for the benefit of millions of at-risk patients, in my view... It would be a considerable setback to pharmaceutical development and patient care if we do not prevail in this litigation.

With respect to Amarins ongoing patent litigation with generic pharmaceutical companies.

You are likely aware that the trial portion of litigation was completed in late January.

Post trial briefs are expected to be publicly available on the court docket on February 28.

As previously expressed amarin does not plan to provide commentary regarding details of this ongoing litigation.

Based on court proceedings, the court's decision on this matter is expected near the end of March.

Amarins commercial plans assume that the courts uphold our pans and otherwise ensure that amarin retains the exclusivity, which we believe we deserve under the law.

Such exclusivity will support Amarins further promotion and education.

Leading to expanded use for the benefit of millions of at risk patients.

In my view.

It would be a considerable setback to pharmaceutical development in patient care, if we do not prevail in this litigation.

As we described before the litigation began.

John Theroux: As we described before the litigation began,

John Theroux: We believe that our legal arguments are persuasive and should prevail. The U.S. Patent Office was convinced of the appropriateness of our patents, and we believe that the courts should conclude similarly. Amarin has made considerable progress in the past year. But, in many respects, we are just getting started.

While there is risk in any litigation.

We believe that our legal arguments are persuasive and should prevail.

The U.S. patent office was convinced of the appropriateness of our pens and we believe that the courts should conclude similarly.

Amarin has made considerable progress in the past year.

In many respects, we're just getting started.

John Theroux: A year ago, there were four primary areas of concern expressed to us by investors. One, FDA approval of an expanded Visepa label. Two, competition from Epinova. 3. Accuracy of our financial resources. And 4. Results of the ANDA litigation. Three of these four have been successfully addressed, with the fourth, the results of the litigation, scheduled to be addressed soon.

A year ago. There were four primary areas of concern expressed to us by investors one FTC approval of an expanded the SEPA label to competition from Epanova, three adequacy of our financial resources and four.

Results of the Anda litigation.

Three of these four have been successfully addressed with the fourth the results of the end to litigation scheduled to be addressed soon.

Mike Cobb: As previously stated, based on forward proceedings, the Court's decision on the end of the litigation matter is expected near the end of March. After the decision is published by the Court, we will update our stakeholders with regard to this litigation. I will now turn the discussion over to Mike Cobb. Thanks, John.

As previously stated.

Based on board proceedings, the court's decision on the Anda litigation matter is expected near the end of March. After decision is published by the court, we will update our stakeholders with regard to this litigation.

I will now turn the discussion over to my call Mike.

Thanks, John as mentioned the start of this call. Both our 2019 annual report on form 10-K, and today's press release can be found on our website to contain 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.

Mike Cobb: As mentioned at the start of this call, both our 2019 Annual Report on Form 10-K and today's press release 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. Because our actual results for 2019 and financial guidance for 2020 are consistent with what we communicated at the start of 2020, I intend to be brief in my financial review.

Because our actual results for 2009 team in financial guidance for 2020.

Our consistent with what we communicated at the start of 2020 I intend to be brief in my financial review.

Mike Cobb: John reported that our 2019 full-year normalized scripts increased 78%, while our revenue increased 87%. Both percentage increases represent solid growth and reflect strong execution by our commercial organization. Differences are not uncommon between script numbers, which are estimated by third parties, and product shipments for which we have direct records and upon which we recognize revenue. We have, on various prior occasions, provided explanations for such differences. I will summarize such explanations here as the question is likely to otherwise be raised.

I'm reported that our 2019 full year normalized scripts increased 78% well our revenue increased 87%.

Both percentage increases represent solid growth reflects strong institution by our commercial organization.

Differences are not uncommon between script numbers, which are estimated by third parties and product shipments for which we have direct records and upon which we recognize revenue.

We have on various prior occasions provided explanations for such differences.

I will summarize such explanations here his question is likely to otherwise be earnings.

Mike Cobb: As a reminder, Amarin recognizes product revenue when its customers, consisting mostly of independent commercial distributors, take title to the product they order. This is typical practice for pharmaceutical companies. Amarin revenue is not recognized when individual patients fill prescriptions.

As a reminder, amarin recognizes product revenue when its customers consisting mostly of independent commercial distributors take title to the product they order.

This is typical practice for pharmaceutical companies.

And when revenue is not recognized when individual patients filled prescriptions.

Mike Cobb: One factor which in some reporting periods explains such differences is changes in channel inventory levels. However, that explanation was not a major factor in our 2019 results, as channel inventory levels have stayed within a normal and consistent industry range. Another explanation for the recurrent discrepancies between script and revenue numbers is the limitations of the data available to third-party prescription reporting services. Because of practical limitations, they rely on incomplete prescription information for their algorithm calculations.

One factor, which in some reporting periods explains such differences as changes in channel inventory levels.

Not an explanation was not a major factor in our 2019 results as channel inventory levels of stayed within normal and consistent industry ranges.

Another explanation for the.

Recurrent discrepancies between script and revenue numbers.

Limitations of the data available to the third party prescription reporting services.

Because of practical limitations, they rely on incomplete prescription information for their algorithm count calculations.

Mike Cobb: As in the past, such algorithms seem to be delayed in reflecting inflections upward or downward in growth. For 2019, however, our growth was faster than reflected by the algorithms from these third-party providers of ScripTest. As you recall, in the past, on a quarterly basis, they have sometimes overshot and other times undershot in their script estimates. While Amarin anticipates that net total revenue will increase in each quarter of 2020, compared to the corresponding quarter of 2019, at this time, the company is not providing quantified revenue guidance by court. There is not a good analog to follow regarding the market potential of this magnitude being created by a product with the robust clinical results as demonstrated by the CEPR. This is particularly true for preventative cardiovascular care.

As in the past such algorithm seemed to be deleted, reflecting inflections upward or downward and grow.

For 2019, our growth was faster than reflected by the algorithms from these third party providers of script estimates.

As you recall in the past on quarterly basis, then, sometimes overshot and other times under shot and their script estimates.

While amarin anticipates that total revenue will increase in each quarter of 2020 compared to the corresponding quarter 2019. At this time the company is not providing quantified revenue guidance by quarter.

There's not a good analog follow regarding the market potential of this magnitude being created by a product with the robust clinical results as demonstrated by the C.

This is particularly true for preventative cardiovascular chair.

Mike Cobb: The company anticipates continued industry-wide seasonality regarding prescription growth, with, for example, Q1 impacted by annual headwinds caused by beginning-of-the-year insurance deductibles under various health insurance plans. Such beginning-of-the-year headwinds are not specific to Visita. Nor should comments be interpreted as an expression of concern regarding our anticipated Q1 growth. Rather, such comments are intended to be constructive, a reminder that historically the therapies which are most significantly impacted by such seasonal headwinds are therapies which address chronic, asymptomatic medical conditions similar to vasepa.

The company anticipates continued industry wide seasonality regarding prescription growth with.

Example, Q1 impacted by annual headwinds caused by beginning of the year insurance deductibles under various health insurance plans.

Such beginning of the year headwinds are not specific to the sequel.

Nor should comments be interpreted as an expression of concern regarding our anticipated Q1 room.

[noise], rather such comments are intended to be constructive reminder, that historically the therapies, which are most significantly impacted by such seasonal headwinds are therapies, which address chronic asymptomatic medical condition similar to the SEPA.

Mike Cobb: We believe that it is most insightful to review VISEVA growth on a year-over-year corresponding period basis rather than on a consecutive quarter. In prior years, we have communicated similar advice regarding seasonality, and each of those years, investors expressed to us in Q2 that they wished that they had listened. We will see whether the same pattern repeats itself this year.

We believe that it is most insightful to review the super growth on year over year corresponding period basis, rather than on a consecutive quarter basis.

In prior years, we've communicated similar advice regarding seasonality in each of those years investors expressed Hudson Q2 that they wish that they had listened.

We will see whether the same pattern repeats itself this year.

Mike Cobb: We are often asked whether we expect gross margin to further improve with higher volume of seed per production. The answer is that while we do expect further improvements in our gross margin, primarily due to lower cost of goods with a significant increase in volume. We do not expect to see major improvements in our gross margin as Visepa is an expensive product to manufacture. As a reminder and for reference, we have improved our gross margin from 66% in 2015 to 78% in 2019. As we grow, we believe that it is possible that our gross margin as a percentage of product revenue may approach 80%, although reaching that gross margin level in 2020 is not currently expected. Our cash balance on December 31st was $644.6 million. Regarding our cash balance, we today reiterate the guidance we provided in our January 7th press release, which is that we believe our current cash resources are adequate to reach positive net cash flow based on Visepa following its launch for its new FDA-approved cardiovascular risk reduction indication, assuming other significant variables remain in line with our expectations.

We're often asked whether we expect gross margin to further improve with higher volume of the Super production.

The answer is that well, we do expect further improvements in our gross margin.

Primarily due to lower cost of goods with significant increase in volume.

We do not expect to see major improvements in our gross margin as we see but as an expensive product to manufacture.

As a reminder for him for reference we've improved our gross margin from 66% in 2015% to 78% for 2019.

As we grow we believe that it is possible that our gross margin as a percentage of product revenue may approach, 80%, although reaching that gross margin level in 2020 is not currently expected.

Our cash balance on December 31st was $644.6 million regarding our cash balance we today reiterate the guidance we provided in our January 7th press release, which says that we believe our current cash resources are adequate to reach positive net cash flow based on for Super following its.

Launch for its new FDA approved cardiovascular risk reduction indication.

Assuming the other significant variables remain in line with our expectations.

Mike Cobb: We also reiterate our full year 2020 net total revenue guidance at $650 to $700 million. Additionally, we reiterate our 2020 spending guidance as defined in our January 7th press release, including guidance that we expect to spend approximately $250 million on inventory in 2020, which is approximately twice the amount we spent on inventory purchases in 2019. Such guidance also includes that we expect operating expenses to increase approximately $200 to $250 million in 2020 over 2019 levels. Included in these higher operating expenses are previously described increased costs associated with the company's planned expansion of its sales team and other expanded VIFIPA promotional activities, including direct-to-consumer advertising. In the event that net total revenue grows faster than expected, selling, general, and administrative (SG&A) expenses may be higher than reflected in this operating expense guide. Our 2019 results reflect significantly expanded levels of commercial spending compared to 2018. Such added spending supported our reported 87% increase in total revenue during the 2019 year, which growth was faster than we expected at the beginning of 2019. However, our spending was limited as we waited for FDA approval of the SEPA for cardiovascular risk reduction.

We also reiterate our full year 2020, net total revenue guidance at $650 million to $700 million.

We reiterate our 2020 spending guidance as defined in our January 7th press release, including guidance that we expect to spend approximately $250 million on inventory in 2020, which is approximately twice the amount we spend for inventory purchases in 2019.

Such guidance also includes that we expect operating expenses to increase approximately 200 to 250 million in 2020 over 2019 levels.

Included in these higher operating expenses are previously described increased costs associated with the company's planned expansion of its sales team and other expanded the super promotional activities, including direct to consumer advertising.

In the event that net total revenue grows faster than expected so in general and administrative or SGN, a expenses, maybe higher than reflected in this operating expense guidance.

Our 2019 results reflect significantly expanded levels of commercial spending compared to 2018.

Such added spending supported our reported 87% increase in total revenue during the 2019 year, which growth was faster than we expected at the beginning of 29 team.

Our spending was limited as when you waited for FDA approval of the SEPA for cardiovascular risk reduction.

Mike Cobb: While waiting, the pace of revenue growth exceeded the pace of spending growth, which showed up both in reported cash flows, which included multiple positive cash flow quarters in 2019, and in our bottom line operating results. You will note that for Q4 2019, we reported net income. While we are working to achieve sustained and growing net income, given our increased spending assumptions for 2020, which include a significant increase in the size of our sales force and our planned marketing initiatives to robustly launch VISIPA, we anticipate that we will revert to net losses before achieving sustained net increases. Similarly, we anticipate starting in 2021.

While waiting the pace of revenue growth exceeded the pace of spending growth, which showed up both in reported cash flows.

Which included multiple positive cash flow corners in 2019 and in our bottom line operating results.

You will note that for Q4 2009 team we reported net income.

While we are working to achieve sustained and growing net income given our increased spending assumptions for 2020, which includes a significant increase in the size of our salesforce and our planned marketing initiatives to robust we launched the SEPA.

We anticipate that we will refer to net losses before achieving sustained net income.

Similarly, we anticipate starting 2020 with net cash outflows for the sales force expansion as new members of our expanded sales team become productive and as our other forms of expanded promotion take hold.

Mike Cobb: Sponsored ADR Management reiterates that we believe spending levels are likely to vary quarterly. We will consider further expanded promotion, including potential further sales force expansion, if the pace of our revenue growth exceeds our expectations and if such added promotion can be reasonably predicted to pay for itself on a reasonably prompt basis. Our sales team's leadership believes that this is achievable. We hope that they are right; however, it is too early to make judgments in this regard, and changing prescribing habits for physicians often does not occur immediately, even when physicians concur that the clinical data is compelling.

Management reiterates that we believe spending levels are likely to vary quarter.

We will consider further expanded promotion, including potential further salesforce expansion.

The piece of our revenue growth exceeds our expectations and if such added promotion can be reasonably predicted to pay for itself on a reasonably prompt basis.

Our sales teams leadership believes that this is achieved achievable.

We hope that they are right. However, it is too early to make judgment in this regard and changing prescribing habits for physicians often does not occur immediately.

Even when the physicians concur that the clinical data is compelling.

Mike Cobb: Our Planned Spending supports our Guided Revenue... We will continue to evaluate opportunities for further acceleration of such growth. If we become confident that we can do so, we will be happy to adjust our expectations and to make such adjustments publicly known. That being said, our current expectation of growing revenue to 650 to 700 million dollars in 2020, assuming achievement, will be substantial, particularly as we are creating a new market for cardiovascular risk reduction beyond statin therapy. I will now turn the call back over to John for closing remarks. John?

Our planned spending supports our guided revenue from.

We will continue to evaluate opportunities for further acceleration of such growth.

If we become confident that we can do so we'll be happy to adjust our expectations and to make such adjustments publicly known.

That being said our current expectation of growing revenue to 652 $700 million in 2020, assuming achievement will be substantial, particularly as we are creating a new market for cardiovascular risk reduction beyond Stan therapy.

I will now turn the call back over to John for closing remarks, John.

John Theroux: Thank you, Mike. I thank our shareholders for their support. I also thank our employees and many collaborators for your tremendous contribution. We have a very capable team at Amarin, and we are confident in our ability to continue to execute effectively. We are motivated to do so for many reasons, not the least of which is that we are passionate about improving patient care and because we too are Amarin shareholders.

Thank you Mike.

I, thank our shareholders for your support I also thank our employees and many collaborators for your tremendous contributions.

We have a very capable team at amarin and we're confident in our ability to continue to execute effectively.

We are motivated to do so for many reasons not the least of which that we're passionate about improving patient care and because we too are amarin shareholders.

John Theroux: Amarin will be participating in two upcoming investor conferences. The first is tomorrow, the Learing Conference in New York City. The second is the Cowan Conference in Boston on March 2nd. We look forward to seeing some of you at those conferences. With that, we conclude our prepared remarks.

Amarin will be participating and two upcoming investor conferences. The first is tomorrow. The Leering conference in New York City. The second is the Cowen Conference in Boston on March 2nd we look forward to seeing some of you at those conferences.

With that we conclude our prepared remarks, and we'd like to open the line to some questions renter.

Unknown Executive: and I would like to open the

Unknown Executive: in the line to ask some questions.

Unknown Executive: [inaudible]

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

Thank you.

At this time will be conducting a question answer session.

If you like to ask a question. Please press star one from your telephone keypad and a confirmation tone indicate your line is in the question Q.

If I start to feel they to move your question from the Q.

Participants using speaker equipment, maybe necessary to pick up your handset before pressing the star Keith.

Michael Yee: One moment, please, while we poll for questions. Thank you. And our first question today is from the line of Michael Yee with Jeffries. Hey, John, thank you for the update. I appreciate it.

One moment, please let me pull for questions.

Thank you and our first question today is from the line of Michael Yee with Jefferies. Please proceed with your question.

Hey, John Thank you for the update appreciate it two questions and neither of them are about the patent I'll, let someone else asked about that in the U.S. could you provide some more color around thoughts around Q1 seasonality in other words scripts do appear to be growing but you made a comment about maybe.

John Theroux: Two questions, and neither of them are about the patent. I'll let someone else ask about that. In the U.S., could you provide some more color around thoughts around Q1 seasonality?

John Theroux: In other words, scripts do appear to be growing, but you made a comment about how maybe third-party data may not be so accurate if something is changing in an algorithm or some label change or something like that. And then, in Europe, my question is around your comments about the potential for approval at the end of the year. Do you expect to hire a sales force there? Is that in the guidance, in the expense guidance, or when would you think about that? Because that can take some time, and I thought you made a comment about how the patent could be longer than 10 years out there. So just maybe talk to him about that.

Third party data may not be still accurate if something is changing in algorithm or some label change or something like that or do you maybe talk about that and whether it's possible that sales in Q1 could be flat sequentially down just what would you expect versus what scripts are growing and then in Europe. My question is around your comments about the potential for approval at the end.

The or do you expect to hire a sales force there is not in the guidance from expense guidance. How much you think about that because I can take some time.

I thought you made a comment about how the patent could be longer than 10 years out there. So just maybe talk to that thank you.

Oh my goal a thanks for the thanks for the questions and interest with regard to.

John Theroux: Michael, thanks for the questions and interest. With regard to U.S. seasonality, this is not new to us, nor is it unique to us.

The U.S. seasonality you know this is not new to loss.

And it's nor is it unique to US yeah, we've seen.

John Theroux: You know, we've seen Q1 every year on a year-over-year basis, you know, have good growth, but on a consecutive quarter basis, you know, in this case, compared to Q4 of the prior year, you know, often drop off. That included even last year, where we were, you know, coming off of a result presented at AHA and, you know, really very terrific results. So we saw.

Q1 every year on a year over year basis, you know have good growth, but on a consecutive quarter basis.

In this case compared to Q4 of the prior year no often drop off I'm. You know that included even last year, where we were coming off of a.

Results presented at A., J and and.

You know really very terrific results. So we saw.

John Theroux: You know, last year even because of this, we saw close to 40% of patients who are on the drug did not fill prescriptions in the first quarter of last year. Now, a lot of those patients end up coming back later, but, you know, it's these patients are sick patients that are often on five, six, seven, eight therapies, and if they've got, for example, a $5,000 copay, and they go in expecting on a monthly basis an aggregate cost for those five, six, seven drugs to pay a copay of, you know, say $200 to $300, and they get told that it And, you know, one of those decisions tends to be, well, I have got to pay for my pain medicine, but I curtail my spending elsewhere.

You know last year, even you know because of this we saw you know close to 40% of patients who are on the drug I'm not filled prescriptions in the first quarter of last year now a lot of those patients end up circling back later, but.

You know it's you know these patients are sick patients that are often on.

5678 therapies and if they've got for example of 5000 dollar co pay and they go in expecting on a monthly basis on aggregate for those 567 drugs to pay a co pay of let's say 200, $300 and they get told that it's $3000. They start making decisions and one of those decisions tend to be.

I got to pay for my pain medicine, but I curtail my spending or elsewhere. So we we anticipate that we will despite the.

John Theroux: So, we anticipate that we will, despite the really positive results with Visepa and the benefit that it provides for patients, be subject in Q1 of this year to some of that spending discretion of patients. But we also expect that to be offset, and we've seen early signs of that this year, as we did last year, by new patient prescriptions. You know, as to the degree to which the new patient prescriptions will offset the decline in refills in the first quarter, that remains to be seen. I think we had very good NRX numbers in the first quarter of last year. We're hoping for the same this year, but even with those strong NRX numbers in the first quarter of last year, we had some downward revenue numbers versus that versus the fourth quarter, and then it, you know, patients started refilling in the second quarter, and we had, you know, good growth, you know, there, so I, I know various investors.

Barry.

Positive results with the SEPA and the benefits out of provides for patients be subject in Q1 of this year to too. So that does spending discretion of patients now we also expect that to be offset and we've seen early signs about this year as we did last year offset by new patient.

ER prescriptions.

You know as to the degree to which the new patient prescriptions will offset the decline in refills and the first quarter that.

Remains to be seen I think we had very good.

And our record numbers in the first quarter of.

Last year, we're hoping for the same this year, but even with those strong on or off numbers, though and the first quarter of last year, we had some downward revenue numbers versus that.

Versus that fourth quarter, and then it you know patients start refilling and the second quarter and yeah, we had.

Good growth. The you know there outside I know various investors are thanks.

John Theroux: Unknown Executive, Paul Choi, Jordan Zwick, Amarin Corporation Plc Sponsored ADR, Sponsored ADR You were then probably fewer than five, but certainly fewer than 10 of the sales reps that we're still looking to hire at this point in time. I know about 50 or 60 of them haven't completed all their training yet, but some of even the ones that have completed training have just completed it here recently. So, you know, that stuff's taking root. We'll see how those NRXs do in terms of offsetting it.

Sure piece parts of this might go were very as investors have done simpler model that just say, how you're going to grow into consecutive quarter basis, and they just sort of build it that way you know that's a bit Florida people look at things on a year over year basis. They think that you know those patterns are much more predictable because we are you know with Fedex.

Span and sales team, it's still getting its you know its legs on the ground and like I talked about the expanded sales team does for perspective I think it's.

Sure then probably for the five but certainly fewer than 10 of the.

Sales reps that we're still looking to a higher at this point in time of up 50, or 60 of them haven't completed all their training training, yet, but you know some leaving the ones that have completed training of just completed it here recently, so you know that stuff. So you know that stuff's, taking root we'll see we'll see how those interact is a do in terms.

Offsetting.

John Theroux: Industry-wide, but particularly chronic therapy impact of this seasonality, again, not new to us. I don't see it as a negative reflection on the drug. It's just the way that the insurance companies, you know...

This industry wide, but particularly chronic therapy, a impact of this seasonality, but again not new to us I don't see it as a negative reflection on the drug it just the way that the insurance a meal that with our night as Mike Goblet commented I'll kind of had investors in Q2 say Oxys I should.

John Theroux: And as Mike Cobb commented, often I've had investors in Q2 say, ah, jeez, I should have seen that coming as things start picking up again as patients come back on therapy. So hopefully those comments are helpful there.

We've seen that coming up as cute as things start picking up again.

As patients come back on back on therapy. So hopefully those comments are helpful. There with regard to.

John Theroux: With regard to... the EU, you know, we are doing a lot of work already and, you know, which is built into our numbers relative to EU-related planning, you know, that includes, you know, pharmacoeconomic analysis, preparations for, you know, reimbursement, you know, which needs to occur on a country by country basis, you know, mapping out how one would approach a sales launch in Europe. As we have done throughout much of Amarin's history, we use a combination of employees and contractors, sometimes as individuals, sometimes as consultants, to do that work. And, you know, we're taking a similar approach to that in Europe at this point in time. So our aim is to be in a position that if the right answer is for us to launch in Europe, but we're also going to be, in the time frame described previously. You know, focus and timing are all important here. Focus got us successfully through the reduced study.

He do you know we are doing a lot of work already and which is built into our numbers relative to our E. U related planning you know that includes.

Pharmacoeconomic analysis.

Preparations for you know reimbursement you know what needs to occur on a country by country basis, you know mapping out how one would approach a sales launch in Europe.

As we have done you know throughout much of Amarins history, we use a combination of employees and contractors or sometimes as individual sometimes as as consultants to do that to do that work and you know we're taking a similar approach to that in Europe at this.

Point in time, so our aim is to be in a position that.

If the right answer is for us to launch in Europe that we could do that.

But we're also going to be a in the timeframe described previously you know focus and timing is all important here focus a got us successfully through the reduce it study right now I don't think of anything more important than we could be doing a globally then to ensure that were successful.

John Theroux: Right now, I don't think there's anything more important than we could be doing globally to ensure that we're successful with the launch here, you know, in the United States. So, as we've talked about, let's get the initial comments back from EMA, and at that point in time, we will get into more active dialogue with the various companies who think that they should be our partner for Europe, and then we'll make some choices from there. But, you know, spending money on putting ourselves in a position to be able to either partner or launch ourselves is in the guidance that we've provided. That being said, if we were to be launching, our assumption is that approval will come in the fourth quarter. So the real expense of a launch, if we were to do it ourselves, really isn't much. Predominantly in 2020, it would be in the would be in the following year. So hopefully, those comments will help.

What would the launch here in the United States. So as we've talked well, let's get the initial comments back from M.A. and at that point in time, we will.

Get into more active dialogue with the various companies who thinks that they should be our partner for Europe and then we'll make some choices are from from there, but you know spending for putting ourselves in a position.

To be able to either partner.

Or to launch ourselves.

You know are in the guidance that we've provided the all that being said if we were to be launching our assumption is approval in.

Fourth quarter, so the real expensive launch if we were doing ourselves really isn't.

Prominently in 2020, it would be in the would be in the following year. So hopefully those commentaries.

Thank you.

Our next questions from the line if he has been Rahimi with Roth capital. Please proceed with your question.

Yasmeen Rahimi: Our next question is from the line of Yasmeen Rahimi with Roth Capital. Hi team. Thank you for taking the questions and congratulations on the continued tremendous progress that you're making. John, thank you for sharing with us that eight abstracts have been accepted at the upcoming ACC. I would love to hear your thoughts to the extent that you can give us color on the late breaker, which is supposed to show us EPA levels as produced by IT and related to cardiovascular outcomes. Can you maybe tell us a little bit how that data set is different from what we have seen at last AHA, to the extent that you can? And then the second question is, in regards to the failure of strength, as you've been discussing with physicians as well as some of the top experts in the space and third-party providers, has the failure of strength created sort of even more buzz for VSEPA? I would love to hear sort of the sentiment that you're getting on the heels of that. Thank you so much for taking the time to answer my questions.

Hi team I'm. Thank you for taking the questions and congrats on the continued tremendous progress I think we're making.

John Thank you Mr. Wang with assets heat.

Hi, Thanks that that an upcoming APC I would love to hear your thoughts today and maybe you can give us color on the late breaker, which is supposed to show up.

Pea level.

Yeah and related to cardiovascular outcome can you maybe tell us a little bit how that data that is different from what we have seen at last eight say links and that you can and then the second question is in regard to the failure of strength.

You know discussing ways, you know a position as well and some of the top.

Based on third party providers has the failure strength create it sort of even stronger by a service see though I would love to hear sort of the settlement that you're getting on to help with that thank you. So much for taking my question.

John Theroux: Yasmeen, thanks for the nice comments and for the questions. With regard to your first question in ACC, we are very pleased by the attention that is coming our way for publication and research. You may remember, particularly those who have followed Amarin for a while, we had publications coming out of the successful Phase III Anchor and Marine studies for five, six years after those studies were completed. The more you dug, the data kept getting better and better and better, and I suspect here with Reduceit, we will be having streams of publications that will last for years as well. So we are looking forward to the multiple presentations that are coming up here in March at ACC, and as noted on the call, we will be having a webcast of summaries of those presentations by some of the authors of the various items. With respect to the late breaker, ACC is very adamant that we not describe details of it.

He has been a thanks for the thanks, Thanks, nice comments and for the questions.

With regard to your first question and they see say yeah. We are very pleased by the the attention that is coming our way for publication and research.

You may remember I'm, particularly those who follow them or for a while you know we had publications coming out of the successful phase three anchor in Marine studies 456 years. After those studies were completed the but the more you dog the data is kept getting better and better and better.

And I suspect here would reduce it will be having streams of publications that will be lasting years.

As well so we are looking forward to the multiple presentations that are coming up here in March at a HCC and I've commented on the call we will be having a webcast of summaries of those presentations by some of the the authors.

Of the various items with respect to the late breaker yeah. The HCC is very adamant that we not described details of it if we did describe details of it at jeopardizes, our ability to make the presentation at HTC and yeah, we think that having you know information.

John Theroux: If we do describe the details of it, it jeopardizes our ability to make the presentation at ACC, and we think that having information disseminated in a peer-reviewed setting and in front of various cardiologists and other leading physicians is valuable to the brand and its opportunity to help millions of patients. So I can't comment on the details there other than to say that we are looking forward to it and will provide updates as that becomes public. With regard to the failure of the STRENGTH study, you know, I... I think it's probably in a...

Disseminated in a peer reviewed.

Setting.

And in front of various cardiologist another leading physicians as a is valuable to the to the brand and its a opportunity to help you know billions of patients. So I can't comment and details there other than to say that we're looking forward to it and we'll provide update.

As that becomes as it becomes public.

With regard to the failure of the strength.

Study study.

I think at it's probably in a.

John Theroux: In a minor way, it helped us. But, you know, we had been expecting all the way along that our results would be differentiated from what they had. I think to the extent that it helps us, it probably helps us in the two following ways.

In a minor way helped us, but you know it we had been expecting all way along that our results would be differentiated from what they had I think to the extent that helps us it probably helps us in the and the two following ways you know our our managed care coverage is already.

John Theroux: Our managed care coverage is already good. We have managed care coverage on commercial plans that puts us on formulary at about... 85%, roughly of covered lives for commercial plans, and approaching 95% on Medicare Part D plans. On the Medicare Part D plans, some of them have some higher co-pays; we're working through that, but most of them don't have restrictions, have restrictions predominantly on our prior label. And as we talked about, we're working through those mentioned in the call, three plans where the restrictions have been removed.

Good you know we have.

You know managed care coverage on commercial plans that puts us on formulary at about.

85% roughly of covered lives for commercial plans and you know approaching 95% on Medicare part D plans on a Medicare part D plans some of them have some higher copays, we're working through that.

But most of them don't have.

Restrictions there are about a third of the commercial plans that.

Have restrictions predominantly to our prior label and you know as we talked about you know we're working through those.

Mentioned in the call three plans, where the restrictions have been.

John Theroux: And that's somewhat extraordinary in the sense that once you're on formulary, getting formularies to change coverage mid-year is often difficult; they have their reviews of those things annually, typically only more than twice a year. For them to do something off-cycle is really, I think, a reflection of the enormity of the value of VISIPA in terms of benefit to patients, but also the cost effectiveness that's been demonstrated through real world data, but also through the couple of pharmacoeconomic analyses that have been presented, one of which showed that VISIPA, even at twice the price, would be cost effective. And the other that went beyond that and looked at the full costs showed that Visepa saves money for society overall in most scenarios. And to the extent that managed care might have said, well, geez, let's wait and see what the other study looks like, which is sometimes a pattern to try to have multiple drugs competing against each other.

Removed and you know that somewhat extraordinary in the sense that once you're on formulary getting formulary to change coverage mid year, you know often they just have the often they have there.

Reviews of those things annually typically.

The only.

No more than twice a year for them to do something off cycle is really I think a reflection of the enormity of the value of the SEPA in terms of benefit to patients, but also the cost effectiveness. That's been demonstrated through real world data, but also through the couple of.

Local economic analyses that have been presented a one of which showed that obviously, but even at twice the price would be cost effective together that but beyond that and looked at full cost and.

Showed that he oversees the saves money for society overall and most of it in most scenarios and to the extent that managed care might have said well Gee, let's wait and see what the other study looks like which is sometimes a pattern to try to you'll have multiple drugs.

Competing against each other you know not having that drug coming along sort of takes away that potential approach for managed care. Now we think we already have a very effective a an affordable price them and the price of the SEPA is comparable to where you know to harvest out and was before I went generic.

John Theroux: Not having that drug coming along sort of takes away that potential approach for managed care. Now, we think we already have a very effective and affordable price. The price of Visepa is comparable to where Torvastatin was before I went generic. It's about, I don't know, some of the new diabetes drugs are two to two and a half times higher. The PCSK9s are much higher.

Markets about 100, although the southern do that new diabetes drugs are two two and half times higher the pcsknines are much higher it's how we think that was he was actually a bit of a bargain for him but I.

John Theroux: So we think that Visepa's actually a bit of a bargain for them. But I think not having that other product coming will probably help us move faster in removing some of those remaining restrictions relative to Visepa. And we've had some of the investigators from the STRENGTH study reach out to us, seeing how they could get involved and wanting to learn more. And certainly, hopefully, some of those patients from the STRENGTH study will circle over and become users of Visepa.

I think not having a that other product coming will probably help us move faster and removing some of those remaining restrictions.

Relative to see plan, we've had some of the investigators from.

The strength study reach out to us seeing how they could get involved and wanting to learn wanting to learn more and certainly hopefully some of those patients from those strengths study will circle over and become a you know users on the C., but.

John Theroux: Because I digressed and went a little bit into managed care, I do want to just point out that managed care can always be improved. Our managed care coverage is good. And a lot of drugs, if they're launching, are you going to get on formulary?

Because I die graft and went a little bit into managed care I I do want at this point out that while.

There can always be improvements on managed care. Our managed care coverage is good and you know a lot of drugs if they're launching our you know how are you gonna get on formulary were on formulary. We're trying to do is improved the formulary coverage, but our real challenge is one of education. The coverage is there a it.

John Theroux: We're on formulary. What we're trying to do is improve formulary coverage. But our real challenge is one of education. The coverage is there. It's education.

Education, and it's making up for the fact that for so many years, we were spending almost all of our resources on research and development and you know now we're getting into the commercialization of at Neal. This is a transformative year for the company in that regard and we're gonna be the one and only the high hurdle that we've created.

John Theroux: And it makes up for the fact that for so many years, we were spending almost all of our resources on research and development, and now we're getting into the commercialization of it. And this is a transformative year for the company in that regard, and we're going to be the one and only. The high hurdle that we've created based upon reduced results is going to make it very difficult for someone to come up behind us. So it's up to us to make sure that we're doing the right thing here to help millions of patients. And this is one of those areas where we can help patients and shareholders at the same time, and we're proud to be doing so. Hopefully, those comments will help.

Based upon reduce it Oh results I think it's going to make it very difficult for someone to come up.

Behind us so it's up to us to make sure that we're doing the right thing here to help millions of patients and this is one of those areas, where we can help patients and shareholders at the same time and we're proud to be doing so hopefully those comments help.

Yasmeen Rahimi: Thank you, John. Very helpful. Thank you.

Hi, Thank her time very helpful.

Yeah.

Thank you. Our next question is for the Atlanta for Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Louise Alesandra Chen: Our next question is from the line of Louise Chen with Cantor Fitzgerald. Hi, congrats on the quarter and thanks for taking my questions here. So my first question for you is with respect to your sales guidance; do you include anything for the EU in that guidance? And then, secondly, you mentioned some additional improvements in coverage in the coming months. Can you provide any more color on how that will translate into sales or what you expect there? And then the last question I had for you was with respect to who is prescribing SEPA? Is it mostly specialists? And then is that mix going to change over time to more primary care as you get out with this new label and your promotion? Any thoughts that would be very helpful? Thank you.

Hi, congrats on the quarter and thanks for taking my questions. Here. So my first question for you is with respect to your sales guidance. Do you include anything for the you in that guidance and then secondly, you had mentioned some additional improvements in coverage in the coming months can you provide anymore color on how that will translate into.

Sales or what you expect there and then the last question I have for you watch with respect to who is prescribing the c., but is it mostly specialist and then as I get to mix going to change overtime to more primary care as you get out with this new label and your promotion any thoughts there will be very helpful. Thank you.

John Theroux: Louise, hi. Thanks for the questions. With regard to our guidance, no, there's not anything in there for the EU. If we were to get approved and launch this year and add revenues for the EU, that would be incremental. With regard to coverage improvements, as I just mentioned, I think our real upside here is through education, awareness, and usage. We are anticipating improvements in managed care coverage to the extent that that improvement were to happen faster than what we're expecting. That could be upside, but we have baked into our expectations that we will get continued improvement in guidance, some of which we saw at the beginning of the year, some of which we've referenced happened here earlier, and some of which we have seen occurring here in the first quarter. With respect to who's writing the drug today and where that might come from in the future, I'm accompanied here by members of our team. Let me turn that one over to Aaron Berg, our Chief Commercial Officer. Aaron?

Louise high.

Thanks, Thanks for the questions with regard to our guidance no. That's there's not anything in there for the EU. If we were to get approved and launched this year NAD revenues for the you that would be incremental with regard to coverage improvements you know I just mentioned I think our real upside here is.

Through education awareness and usage.

The Oh, we are anticipating improvements and managed care coverage to the extent that that improvement were to happen faster than what we're expecting a you know that could be upside, but we have baked into our expectations that we will get continued improvement.

In guidance, so some of which we saw the began the year solitary references happened here earlier and you know some of which we have.

You know seen occurring.

Here in the in the first quarter with respect to whose writing the drug today and where that might come from in the future.

Company here by the various of our team let me turn that went over to Aaron Berg, Our chief commercial officer error.

Aaron D. Berg: Thanks, John. And thanks for the question.

Thanks, John and thanks for the question right now about 80% of the prescription come from PCP that includes NPS ph cardiologists are about 15% and growing rapidly endocrinologists are another 5%.

Aaron D. Berg: Right now, about 80% of the prescriptions come from PCPs. That includes NPs and PAs. Cardiologists are about 15%, and growing rapidly, endocrinologists are another 5%.

Aaron D. Berg: The fastest-growing group amongst those on a percentage basis are cardiologists, followed by endocrinologists. The specialists are growing faster, but there are just many, many, many more primary care physicians. So, at an aggregate volume, primary care is making up the biggest increase, and that's consistent with what Aaron's team has expected. On growth, I mean, you know, last year in terms of overall growth, we had about 87% increase in revenues. We had about a 50% increase in prescribers.

The fastest growing group amongst those on a percentage basis is the is the cardiologist a fall by the endocrinologists specialists are growing faster than just many many many more primary care physician. So as an aggregate volume are the primary care.

Making up the big biggest increasing your that's consistent with what Oh, what Aarons team has had expected and you know on the.

On the growth I mean, you know last year in terms of the overall growth we had a anybody 7% increase in revenues, we had about a 50% increase and prescribers.

Aaron D. Berg: shows that existing prescribers are prescribing more, but we also had more prescribers coming on board, and a lot of those added prescribers certainly included cardiologists and endocrinologists, but the biggest piece of that was in primary care.

So that shows that existing prescribers are prescribing more but you know we also have more prescribers coming on and a lot of those added prescribers certainly included cardiologist and endocrinologists, but the biggest piece of that was in primary care.

Louise Alesandra Chen: All right, thank you. Our next question is from the line of Jessica Fye with J.P. Morgan. Hi, this is Yuko on the call for Jessica.

Hi, Thank you.

Thank you.

Our next question is from the line of just fine with JP Morgan. Please proceed with your question.

Hi, This is you're going to call for Jessica. Thank you for take your questions. I know, it's early days, but how that's tracking from a productivity standpoint, I think with the prior salesforce, except when you talk about holiday.

Jessica Macomber Fye: Thank you for taking our questions. I know it's early days, but how are the new reps tracking from a productivity standpoint? I think with the prior Salesforce expansion, you talked about how they hit and exceeded target productivity metrics ahead of schedule.

Hi, good productivity metric for how to.

John Theroux: A good question. Certainly something we're monitoring. It really is too early. Some of them aren't even in the field yet. Some of them have just gotten into the field. I think, you know, last year, what we expressed was that when we got to about mid-year, you know, these were comments that we were making in August on our investor call and investor meetings that, you know, by August, about 90% of the sales reps that we had hired and were on board were covering their costs, which is really fast for new sales reps, but they weren't covering their costs in Last year with the new sales reps, we had anecdotes of progress. This year, we've got anecdotes of progress, but it really is too early to make judgments there.

Thank you.

I'm. Good question, certainly something we're monitoring it really is too early some of them or some of them our name in the field yet some of them of just got into the field I think Oh last year, what we express was that when we got to about mid year. These were comments that were making and analog.

Just in our Investor call under Investor meetings that day.

By August about 90% of the sales reps that we had hired and were on board.

We're covering their cost which is.

Really fraph, you know for new sales reps, but.

They weren't covering their cost in the first quarter last year, where the new sales reps, we had anecdotes of progress. This year Weve got anecdotes of progress, but they really is too early to you know make judgment. There I think we've hired terrific people, we've got a terrific managers so the the launch mature.

John Theroux: I think we've hired terrific people, we've got terrific managers, and the launch materials are crisp. It's nice to be out with an FDA label, which makes the description of what we're doing much easier. I think the other promotional materials, and particularly when we get to DTC advertising, I think it's going to help lift things considerably. But with regard to the new sales reps' performance, anecdotally encouraging, but really too early to make any judgment. Let's hope they do what was done last year, but it's too early to make that conclusion.

Charles or Chris, but it's nice to be out with the FDA label, which is a makes the description of what we're doing you know much easier I think the other promotional materials and particularly get the DTC advertising I think it's going to help lift things considerably, but with regard to new sales reps performance anecdotally encouraging.

Really too early to make any judgment.

But hope they do what they what was done last year, but it's too early to make that conclusion. So thanks.

John Theroux: So thank

Thank you.

Jessica Macomber Fye: Thank you. Our next question is from the line of Paul Choi with Goldman Sachs. Hi, good afternoon, everyone, and thanks for taking our questions. John, maybe one question just on the new prescription growth. Can you maybe speak to what percentage or mix, I guess, is coming from first-time or new prescribers and how much of that versus your new expanded physician target base you feel like you're hitting at this point? And then I have a follow-up with an operational question.

Our next questions from the line of Paul Choice with Goldman Sachs. Please proceed with your question.

Hi, good afternoon, everyone and thanks for taking my questions.

John maybe one question just on the new prescription growth can you maybe speak to what percentage or mix I guess is coming from first time or new prescribers and how much on that person is your new expanded position target base you feel like you're hitting at at this point and then I've a follow up an operational question.

Yes, I'll I'll make some comments Aaron if you go things you want to add onto this yeah, let let let me know so.

Paul Choi: Yeah, so I'll make some comments. Aaron, if you have other things you want to add to this, you know, let me know. So to really get into answering that question, it requires us to look at the country in sort of a divided way.

To to really get into the answering that question, Rick acquirers us to look at the country and ER and sort of a divided way our sales team last year was.

John Theroux: Our sales team last year was calling on about 50,000 doctors, not calling with high enough frequency, but with a lot of white space in the country and calling on doctors for the first time. We now have much less white space in the country, and we are increasing the frequency of our sales calls because, while we're doubling the sales force, we've increased the number of targets by about 50%. So to really sort of get into that, I think you've got to look at where we were calling on people and what the impact was in the areas that we were calling on people. And there, as we added docs and we went last year from about 20,000 targets to about 50,000 targets, the preponderance, I think over 80%, and Aaron will correct me if I'm wrong, over 80% of that expanded target group became prescribers of Visepa last year, which is encouraging.

Calling on you know about 50000 docs not going on with high enough frequency, but you know with a lot a lot of white space in the country and and calling on doctors for the first time, we're now have much less white space in the country.

And we are increasing the frequency of our sales calls because while we doubled the salesforce we increased the the the number of targets by about 50%. So to the really sort of get into that you have to look I think you've got to look at where where we calling on people on what was the impact in the area.

Is that we were we were calling on people and you know there you know as we added docs and we added we went from last year for about 20000 targets to about 50000 targets, a preponderance of think over 80% internal correctly ever wrong. Okay.

Were 80% of that expanded target group.

Became prescribers of receivables.

John Theroux: There clearly were prescribers added who were not calling on them, as well. And, you know, now with a label, all of these prescribers have a significant opportunity to, you know, increase their prescribing. So as we look at both, you know, how do we take prescribers who we probably weren't calling on, in fact, we're convinced we weren't calling on frequently enough last year, and increase their awareness. You know, now we have a new label, they're still somewhat early in the VASIPA story, but also go to new targets, some of which are really being introduced to VASIPA for the first time. And Aaron, if you care to add further...

You know last last year, you know, which is in which is encouraging there clearly were prescribers added who were not calling on.

As well and are now with a label the all of these prescribers have significant opportunity to increase their prescribing. So as we're you know from where we are now we're looking at both the how do we take prescribers, who we probably weren't calling on in fact, we're committed to weren't calling on frequently enough.

Last year and increase their awareness now we have a new label are still somewhat early to the Seapass story, but also go to new target some of which are really being introduced to the SEPA for the for the for the first time and Aaron If you care care to add further idle and John Paul Thanks for the question.

Aaron D. Berg: Thanks for the question.

Aaron D. Berg: As John said, we've done very well increasing the number of prescribers. Our real opportunity is with our frequency to drive volume in those prescribers. We still have a small percent of the entire lipid market. As you know, it's a very large market, and that's our opportunity, and that's our plan, to get more out of those prescribers.

As John said, we've we've done very well increasing the number of prescribers are real opportunity is with our frequency to drive volume in those prescribers, we still have a small percent of the entire lippitt market. As you know, it's a very large market and that's our opportunity and that's our plan is get more out of those prescribers and that will drive our success.

Yes.

I'm looking at thanks, a lot.

Go ahead go one more or no. Thanks, yeah, Yeah, just as a follow up with regard to your supply chain.

Aaron D. Berg: Out of those prescribers, and that'll drive our success. I'm looking at the clock and... Go, go, go ahead, Paul.

Some of your Apiay suppliers are from Asia could you maybe speak to your out amount of inventory on hand, and how you're thinking about potential contingencies that anything from overseas suppliers and I guess, that's affected our impaired by some of the current things going on.

Paul Choi: Unknown Executive, Paul Choi, Jordan Zwick, Amarin Corporation Plc Sponsored ADR

John Theroux: So we are, we are globally diversifying our supply chain. The, uh, you know, the We were producing nothing in China for our product.

So we are we are globally diversifying our supply chain.

The.

Yeah.

We were producing nothing in China for our for our product.

John Theroux: And as you may recall, we ended up last year getting out ahead of this by making sure not only we diversified, which does mitigate risk, but also that we were building inventory volumes. Certainly the nature of our manufacturing process precludes, you know, any.., product issues, but in terms of supply chain interruption, it would have to be pretty catastrophic before we would have to worry about either the ability of us to get product from multiple regions of the country or for us to burn through the whip that we have in hand of non-encapsulated oil, which is the encapsulation can happen here in the United States, or the surplus we have of inventories that we've built up here because we just don't know how fast the revenues are going to grow.

And as you may recall, we ended up.

Last year getting out ahead of this by making sure not only we diversified but which.

Does mitigate risk, but also that we were building a inventory.

Volume so <unk>.

Certainly the nature, our manufacturing process precludes you know any.

Product issues, but in terms of supply chain interruption, it would have to be pretty catastrophic before we would.

I have to worry about either the ability of us to get product from multiple regions of the country or for us the.

Burn through the whip that we have in hand of non encapsulated oil, which is the encapsulation can happen here in the United States.

Or or the surplus we have of inventories that we've built up here because we just don't know how fast the revenues are going to going to grow so up I know lots of companies are in packed and by that but I would consider us to be somewhat in the lower end of the respect drama and less krona violators virus becomes a.

John Theroux: So I know lots of companies are impacted by that, but I would consider us to be somewhat on the lower end of the risk spectrum unless the coronavirus becomes sort of to the extent people just aren't even leaving their homes. But I think we're, in which case, much bigger issues. So I think we're okay there. Looking at the clock, I've been giving advice to investors over the years that these things really shouldn't go beyond an hour. Hopefully, these comments have been useful to you.

You know sort of to the extent people, who aren't even leaving their homes, but I think we're in which case much bigger issues. So I think we're okay. There.

Looking at the clock.

I've been giving it twice for investors over the years that these things really shouldn't go beyond an hour.

Hopefully these comments have been a useful to you I do think that amarin is rapidly becoming a new standard of care. It's clearly the fastest growing a cardiovascular drugs. That's that's out there.

John Theroux: I do think that Amarin is rapidly becoming a new standard of care. It's clearly the fastest growing cardiovascular drug that's out there. We're pleased with the results that we had in 2019, and we think we're off to a good start here in 2020. This is a transformational year for us, and we look forward to providing you with additional updates as we move forward. So, thanks a lot for your interest today, and I look forward to speaking with you soon.

We're pleased with the results that we had in 2019, we think we're off to a good start here in 2020, you know this is a transformational year for us and we look forward to providing you with additional updates as we move forward. So thanks, a lot for your interest today and look forward to speak with you soon bye.

Unknown Executive: Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.