Q2 2020 Amarin Corporation PLC Earnings Call

[music].

Greetings and welcome to the Amarin second quarter 2020 earnings call.

Operator: Greetings and welcome to the Amarin second quarter 2020 earnings call. At this time, all participants are in a listen-only mode.

At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator systems. During the conference. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.

Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Elizabeth Schwartz from Investor Relations. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of the SEPA prescriptions, SEPA product and licensing revenues, costs, gross margin, and other commercial metrics. Our current plans and expectations regarding spending, including expenditures for promotion of the SEPA and for purchases of additional supplies of the SEPA. Our current expectations regarding the adequacy of our financial resources.

Now, let's turn the conference over to your host Elizabeth Schwartz with Investor Relations.

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.

He put prescriptions, but keep a product and licensing revenues cost gross margin and other commercial metrics, our current plans and expectations regarding spending including expenditures for promotional this he thought oh for purchases of additional supply of the seat.

Our current expectations regarding adequacy here for a financial resources, our current plans and expectations for product revenue growth salesforce productivity and product promotion in light of covet 19 in the potential for added attention to cardiovascular risk reduction drugs like the steep as a result of cobot, 19th our current plans and expectations regarding our appeal of the district corpus.

Elizabeth Schwartz: Our current plans and expectations for product revenue growth, sales force productivity, and product promotion in light of COVID-19 and the potential for added attention to cardiovascular risk reduction drugs, like SEPA, as a result of COVID-19. Our current plans and expectations regarding our appeal of the District Court for SEPA-related patent litigation decision to the Federal Circuit. And our current plans and expectations related to the potential launch of generic versions of the SEPA by generic companies and by ourselves, including expectations regarding ANDA approvals by the FDA, generic cost-effective supply availability, timing, potential levels of damages, and ability to recover the SEPA growth if the appeal succeeds. Our current expectations for regulatory reviews outside the United States regarding VISIPA approval. Our goals regarding the timing, scope, and success of international expansion, including expectations regarding our ability to launch VISIPA in Europe and our expectations in China for clinical trial results and the potential to bridge reduced results in labeling and promotion of VISIPA through a partner in China.

People related patent litigation decision to the federal circuit, and our current plans and expectations related to the potential launch of generic versions of the SEPA mucinex companies and by ourselves, including expectations regarding anda approvals by the FDA generic cost effective supply availability hardening potential levels of damages and ability to recover has hit the growth if that.

He will succeed.

Our current expectations for regulatory with use outside the United States regarding the CE approval.

Goals regarding the timing scope and success of international expansion, including expectations regarding our ability to watch the seat, but in Europe, and our expectations in China for clinical trial results in potential to bridge reduce it results in labeling and promotion other people to our partner in China, Our current plans and expectations regarding the seat the exclusivity outside the United States, including Europe and China.

Elizabeth Schwartz: Our current plans and expectations regarding VISIPA exclusivity outside the United States, including Europe and China. Our current plans for commercial expansion in the United States, with and without the entry of potential generic competition. And our current plans and expectations regarding clinical studies of VISIPA related to COVID-19 and regarding the results of the EVAPORATE study. These statements are based on information available to us today, August 4, 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.

Our current plans for commercial expansion in the United States with and without entry of potential generic competition and our current plans and expectations regarding clinical study. This he thought related to cover at 19 and regarding their results at the Evaporate study. These statements are based on information available to US today August 4th 2020.

We may not actually a cheaper goals carry out our plans or intentions or meet expectations disclosed in our forward looking statements actual results or if that's could differ materially.

So you should not place undue reliance on these statements we see no obligation to update these statements as circumstances change a forward looking statements do not reflect the potential impact of significant transactions, we may enter into such as mergers acquisitions dispositions joint ventures or any material agreements that we may enter into an end to terminate for additional information concerning the factors.

Elizabeth Schwartz: We assume no obligation to update these statements as circumstances change. Our foregoing statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate. For additional information concerning the factors that could cause actual results to differ materially, please see the risk factors section of our annual report on Form 10-K for the year ended December 31, 2019, and the Form 10-Q filed for the quarter ended June 30, 2020. These documents have been filed with the SEC and are available through the Investor Relations section of our website at www.amarincorp.com.

That could cause actual results to differ materially. Please see the risk factor section of our annual report on form 10-K for the year ended December 31st 2019, and the form 10-Q filed for the quarter ended June Thirtyth 2020.

Documents have been filed with the FCC at our available through the Investor Relations section of our website Amrun Corp. Dot com I encourage everyone to read. These documents. This call is intended for investors and Amarin and is not intended to promote the use of the seat the outside its approved indication and archive of this call will be posted on the Amarin website also in the Investor Relations section.

Making prepared remarks on today's call will be giant, they're all president and Chief Executive Officer.

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

Aaron Berg, Chief commercial officer, and Michael Carroll, Chief Financial Officer, after prepared remarks, well respond to questions. Some of you submitted questions in advance and more practical we've tried to cover responses in our prepared comments I remind you that typically listening to call out of this nature, a multiple audiences, including existing investors potential new investors.

<unk> regulatory authorities current and potential collaborators and current and potential competitors as always in this call will you attempt to provide constructive information without compromising our competitors and strategic positioning.

Please note that we anticipate the call will be over an hour I now turn the call over to John Thero, President and Chief Executive Officer Cameron.

Hello, everyone and thank you for joining us today. During this call will cover many topics, including Q2, 2020 operating and financial results past that potential future impact to cope with 19 on our revenue growth in operations commercial priorities in the United States, including our recently launched promotional but.

Elizabeth Schwartz: I remind you that typically, there are multiple audiences listening to calls of this nature, including existing investors, potential new investors, employees, regulatory authorities, current and potential collaborators, and current and potential competitors. As always, on this call, we attempt to provide constructive information without compromising our competitive and strategic position. Please note that we anticipate the call will be over an hour. I now turn the call over to John Farrell, President and Chief Executive Officer of Amarin. Hello everyone.

People via television commercials and related forms of communication.

Commercialization plans purposes, but in Europe upcoming milestones, including presentation of results over the SEPA clinical trial in China and results of the evaporate study.

And patent litigation status in the United States.

We will start with this last topic first as patent litigation is typically the first topic of inquiry from investors.

John Farrell: And thank you for joining us today. During this call, we'll cover many topics, including Q2 2020 operating and financial results, and the past and potential future impact of COVID-19 on our revenue growth and operations. Commercial priorities in the United States, including our recently launched promotion of the SIPA via television commercials and related forms of communication. Commercialization Plans for VACIPA in Europe, Upcoming Milestones, including Presentation of Results of the VACIPA Clinical Trial in China and Results of the EVAPORATE Study, and Patent Litigation Status in the United States. We will start with this last topic first, as patent litigation is typically the first topic of inquiry from investors. As a reminder, this patent litigation is in the United States only and pertains to the rights to mark and sell Visepa for its first FDA-approved indication, the indication for lowering triglyceride levels in patients with very high triglyceride levels, defined by FDA's FDA-approved label and by medical guidelines as trig In Canada, for example, we and our commercial partner did not seek that triglyceride-lowering indication for vasepine. Similarly, in Europe, we are not seeking that indication.

As a reminder, this patent litigation is in the United States only in pertains to the rights to Mark in cell, but see before its first ft approved indication the indication for lowering triglyceride levels in patients with very high triglyceride levels defined by Yep <unk> FDA approved Lee.

Cable and by medical guidelines as triglyceride levels greater than or equal to 500 milligrams per deciliter.

In Canada for example, we in our commercial partner did not seek that triglyceride lowering indication for but SEPA.

Similarly in Europe, we're not seeking that triglyceride lowering indication.

Rather our priority in such international labeling has been on cardiovascular risk reduction based upon the landmark results of the reduce it cardiovascular outcome study.

Accordingly, the U.S. litigation does not directly impact the significant but see potential in those geographies due both to new regulatory exclusivity in different patent protection.

Or in most other areas of the world, where we are pursuing or we may in the future pursue a cardiovascular risk reduction indication for placebo.

Our ongoing appeal to the federal circuit in the U.S. patent litigation is in response to the decision in March of this year from the Federal District Court in Nevada, which ruled that the discoveries underlying the seapass pads that protected our initial ft approved indication for.

John Farrell: Rather, our priority in such international labeling has been cardiovascular risk reduction based upon the landmark results of the Reduce-It Cardiovascular Outcomes Study. Accordingly, the U.S. litigation does not directly impact the significant FISIPA potential in those geographies. Do both with new regulatory exclusivity and different patent protections. Or, in most other areas of the world where we are pursuing, or we may in the future pursue, a cardiovascular risk reduction indication for placebo. Our ongoing appeal to the Federal Circuit in the U.S. patent litigation is in response to the decision in March of this year from the Federal District Court in Nevada, which ruled that the discoveries underlying Visepa's patents that protected our initial FDA-approved indication for Visepa were obvious. Thus, in effect... The court ruled that the patents upon which Amarin relied should not have been granted by the U.S. Patent Office. This decision was unexpected by everyone. Including, we understand, the generic companies involved in the litigation. As discussed in the past, we believe that the district court decision is flawed.

To see but we're obvious.

The us in effect.

The court ruled that the pads upon which Cameron has relied should not have been granted by the U.S. patent office.

This decision was unexpected bye everyone.

Routing, we understand the generic companies involved in the litigation.

As discussed in the past, we believed that the district court decision is flawed.

Having lived and worked through the early development up a c., but prior to the results of the marine an anchor clinical studies. It is clear to me that unique aspects of SEPA, we're not obvious at that time to others outside of Amarin.

And that it was Aaron's scientific insights developed over years of experience, which led to the successful development of a super.

It was a development path that other scientist and other drug developers had not pursued.

Nonetheless, a decade later the district court judge in trying to go back in time.

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Unfortunately, the judicial process is such that it doesn't matter that I, you or others conclude that the district court's decision was wrong.

It also.

John Farrell: Having lived and worked through the early development of Vasepa prior to the results of the Marine and Anchor Clinical Studies, it is clear to me that the unique effects of Vasepa were not obvious at that time to others outside of Amarin, in that it was Amarin's scientific insights developed over years of experience which led to the successful development of the... It was a development path that other scientists and other drug developers had not pursued. Nonetheless, a decade later, the district court judge. Trying to go back in time.

Doesn't seem to matter at this district court ruling if allowed to stand is likely to leave many patients are necessarily at high risk for major adverse cardiovascular events.

Potentially at unnecessary risk for other medical risks, which the seat, but maybe able to address in which we are at various stages of investigation.

Potential benefits, which are less likely to be realized it placebo becomes generic.

Unfortunately for patient care. It is not enough to have extraordinary clinical results and F.D.A. drug approval.

Health care professionals and patients need product education.

John Farrell: Interpreted Matters, Unfortunately, the judicial process is such that it doesn't matter that I, you, or others conclude that the district court's decision was wrong. Also, it doesn't seem to matter that this district court ruling, if allowed to stand, is likely to leave many patients unnecessarily at high risk for major adverse cardiovascular events and potentially at unnecessary risk for other medical risks, which BCIPA may be able to address, and we are at various stages of investigation, the potential benefits of which are less likely to be realized if the SIPA becomes generic. Unfortunately, for patient care, it is not enough to have extraordinary clinical results and FDA drug approval. Healthcare professionals and patients need product education. They could also benefit from continued investment in further research and development, and continue to better understand the exceptional VACIPA results achieved in the REDUCIS study and how VACIPA might help other patient populations. This important work for Visepa is only funded by Amarin's promotion of Visepa as a branded product. Usually, drugs become generic after they have been well established and are well-known.

They could also benefited from continued investment in further research and development to continue to better understand.

The exceptional the Super results achieved in the reduces study and how that people might help other patient populations.

This important work for Vascepa is only funded by Amarins promotion of Vascepa as a branded product.

Usually drugs become generic after they have been well established and are well known.

But let's see but is not yet at that stage in thus there is a major and unnecessary risk to patients into society that they could become deprived of the super related education in scientific advancement with resulting the CP usage growth and patient benefits die.

Need by the potential premature introduction of generics.

Furthermore, given the relatively high manufacturing costs in the affordable pricing Cameron has used for bus SEPA.

If the SEPA becomes a generic drug in the United States, we anticipate that little if any money is likely to be see like patients or by insurance companies from the availability of a generic version of a super.

There are many issues with the district court's decision that we would like to argue it have corrected by the court system.

John Farrell: But FACEPA is not yet at that stage, and thus there is a major and unnecessary risk to patients and to society that they could become deprived of FACEPA-related education and scientific advances, resulting in SEPA usage growth and patient benefits stymied by the potential premature introduction of generics. Furthermore, given the relatively high manufacturing costs, the Affordable Pricing Amarin has used for Visepa. If SEPA becomes a generic drug in the United States, we anticipate that little, if any, money is likely to be saved by patients or by insurance companies from the availability of a generic version. There are many issues with the district court's decision that we would like to argue and have corrected by the court. However, in our appeal to the Federal Circuit, we are advised by experienced and historically successful legal counsel that it is best not to attempt to re-litigate all the matters that were previously argued in district court.

However, in our appeal to the federal Circuit, we were advised by experienced it historically successful legal counsel that is best not to attempt at Reed litigate all the matters that were previously argued in district court.

Instead of trying to correct everything, which we believe was wrongly interpreted or not understood by the district Court.

We have prioritized matters that we believe are the most impactful to the three judge Federal circuit panel that will be deciding our appeal.

[noise] all written legal briefs to the federal circuit had been submitted to the court.

This includes briefs on behalf of both Cameron and the generic companies.

Copies of these briefs are available through the courts Pacer website and are also available within the frequently asked questions section of Amarins corporate web site.

In addition to and separate from the required court briefs from the litigants to third parties submitted briefs to the court expressing their views both of which support amarins petition, albeit with different considerations.

John Farrell: Instead of trying to correct everything that we believe was wrongly interpreted or not understood by the district court, we have prioritized matters that we believe are the most impactful to the three-judge federal circuit panel that will be deciding our appeal. All written legal briefs to the Federal Circuit have been submitted to the Court.

One of these Reeves came from bio.

Well regarded biopharmaceutical trade association, which expressed the importance of the clear inconsistent application to patent law and the values of society of being able to rely on pads to support innovation.

John Farrell: This includes briefs on the behalf of both Amarin and the generic company. Copies of these briefs are available through the court's PACER website and are also available within the Frequently Asked Questions section of Amarin's corporate website. In addition to, and separate from, the required court briefs from the litigants, two third parties submitted briefs to the court expressing their views.

The other brief was submitted by aimed alliance a not for profit health policy organization that works to protect and enhance the rights healthcare consumers and providers.

They are brief emphasized that SEPA remaining branded would lead to increased education regarding the SEPA and improved knowledge among patients caregivers and health care providers about the Seapass clinical trial results and its newly discovered benefits.

John Farrell: Both of which support Amarin's petition, albeit with different considerations. One of these briefs came from BIO, a well-regarded biopharmaceutical trade association, which expressed the importance of the clear and consistent application of patent law and the values of society of being able to rely on patents. The other brief was submitted by Aimed Alliance, a not-for-profit health policy organization that works to protect and enhance the rights of health care consumers and providers. Their brief emphasized that FACIPA remaining branded would lead to increased education regarding improved knowledge among patient's caregivers. Healthcare providers about FACEPA's clinical trial results. Newly Discovered

The next significant step in our federal Circuit appeal is expected to be the oral hearing.

The oral hearing is scheduled for September 2nd at 10 am Eastern time.

Additional information regarding the logistics for this hearing such as listening instructions are provided in the Q section of Amarins website.

Based upon the history the federal circuit, we anticipate their decision to be made public late this year. We're early in 2021.

It is possible that the decision could occur surely after oral argument.

John Farrell: The next significant step in our Federal Circuit of Appeal is expected to be the oral hearing. The oral hearing is scheduled for September 2nd at 10 a.m. Additional information regarding the logistics of this, such as listening instructions, is provided in the FAQ section of AMR. Based upon the history of the Federal Circuit, we anticipate their decision to be made public late this year or early in 2021. However, it is possible that the decision could occur shortly after oral argument or take longer than anticipated. When decided, the court's practice is to post the decision through the court's pacer system.

Or take longer than anticipated.

When decided.

The courts practice is to post the decision through the courts Pacer system.

Amarin, we'll learn of the court decision at the same time is the public because made aware of the decision.

The federal circuit.

At our request.

Actually the schedule the oral hearing and hopefully that quick pace continues to reaching a decision on this important appeal.

I won't try here to fully articulate the legal arguments in the Amarins appeal briefs.

John Farrell: Amarin will learn of the court decision at the same time as the public is made aware of it; The Federal Circuit should, at our request, move quickly to schedule the oral hearing. Hopefully, that quick pace continues to reach a decision on this important appeal. I won't try here to fully articulate the legal arguments in Amarin's appeal.

The lawyers, who drafted them use arguments that should be clear to everyone who reads them.

These briefs emphasize what we believed to be errors in the district court's decision regarding application of the law and errors regarding certain facts, which impacted the district court's decision.

Some investors have asked whether settlement with the generic companies is likely before the federal circuit decision.

John Farrell: The lawyers who drafted them used arguments that should be clear to everyone who reads them. These briefs emphasize what we believe to be errors in the District Court's decision regarding the application of the law and errors regarding certain facts, which impacted the district court's decision. Some investors have asked whether settlement with the generic companies is likely before the Federal Circuit decision. While anything is possible, at this stage, such a settlement is unlikely.

While anything is possible.

At this stage such a settlement is unlikely.

As a reminder, a settlement.

Would only be useful to amarin, if it settled with both of the two active and to litigants on mutually acceptable terms and also gets the district court's decision vacated.

If the district Court's decision is not vacated are settling with the two generic companies that are litigants in this matter won't stop other generic companies from seeking to fill the void.

John Farrell: As a reminder, a settlement. Would it only be useful to Amarin if it's settled with both of the two active parties and the litigants on mutually acceptable terms and also gets the district court's decision vacated? If the district court's decision is not vacated, our settlement with the two generic companies that are litigants in this matter won't stop other generic companies from seeking to fill the void, and it would then be more difficult to stop them. If the current district court decision is reversed as part of the current appeal,

And it would then be more difficult to stop them.

If the current district court decision is reversed as part of the current appeal. The situation is then more clearly and amarins favor.

For generic companies in general the cost of Anda litigation is low relative to the potential benefit.

That is it is certainly much lower than the cost and developing a new drug.

This relatively low cost combined with high potential reward creates a scenario whereby some generic companies are willing to take the risk and seek near term generic product opportunities, even if the magnitude of such opportunities could be larger if they elected to wait.

John Farrell: This situation is then more clearly in Amarin's favor. For generic companies in general, the cost of ending litigation is low relative to the potential benefit. That is, it is certainly much lower than the cost of developing a new drug. This relatively low cost combined with high potential reward creates a scenario where some generic companies are willing to take the risk. Near-term generic product, Even if the magnitude of such opportunities could be larger if they elected to wait, because drug development is, by necessity, typically a long-term endeavor. For various generic companies, the focus appears to be comparatively shorter term. Currently, the end of file is for generic versions of a CP.

Whereas drug development is by necessity typically a long term endeavor.

For various generic companies the focus appears to be comparatively shorter term.

Currently the Anda filers for generic versions of the Super.

Separate from preparing for the oral hearings in the federal circuit appeal or likely considering how much money they want to spend to build supply capacity for the SEPA.

How long will take the build such supply capacity.

Whether they should build such capacity themselves from scratch or try to retrofit existing facilities.

John Farrell: Separate from preparing for the oral hearings in the Federal Circuit Appeal, the government is likely considering how much money they want to spend to build supply capacity for veterans. How long will it take to build such supply capacity? Whether they should build such capacity themselves from scratch or try to retrofit existing facilities. How will they gain the manufacturing know-how required for success in such challenging manufacturing?

How did they gain the manufacturing know how required for success in such challenging manufacturing.

And how much risk they're willing to take.

And then respects to getting into approved by the FDA is not trivial.

However, keep in mind that there is no minimum supply requirements required for getting an IND approval.

How much supply capacity is currently available in qualified for use by the generic companies is not directly known by everyone.

John Farrell: and how much risk they're willing to take. Amarin respects that getting an NDA approved by the FDA is not trivial. However, keep in mind that there is no minimum supply requirement required for getting an ANWB.

Based upon information available to us and based upon our own experience, we believe that existing capacity for qualified supply of a generic SEPA is relatively small compared to the overall market opportunity.

John Farrell: How much supply capacity is currently available and qualified for use by generic companies is not directly known by Amarin, although based upon information available to us. We believe that existing capacity for qualified supply of a generic FACIPA is relatively small compared to the overall market opportunity. That doesn't mean that such generic capacity is trivial, but it is conceivable that generic companies in the near term can potentially find supply capacity to support tens of millions of dollars in revenue. However, While such a level might be important to the generic and Amarin clearly doesn't want to give it up, such a level would only be a small portion of Amarin's total revenue and even a smaller portion of SEPA's revenue, based upon information available to us today.

That doesn't mean that such their capacities trivial.

It's conceivable that generic companies in the near term can potentially find supply capacity to support tens of billions of dollars in revenue.

However.

All such level might be important to the generic companies.

And emirate, clearly doesn't want to give it up such level would only be a small portion of amarins total revenue and even a smaller portion of the seapass potential.

Based upon information available to us today.

If generics launch in the United States.

It is our expectation that they would be launching with limited supply.

John Farrell: If generics launch in the United States, it is our expectation that they will be launched with limited supply. We do not have direct visibility into this number, but that is our current understanding.

We do not have direct visibility into this number but that is our current understanding.

We remind you that manufacturing overseas, but is not easy.

The unique active ingredients into soup is fragile.

John Farrell: We remind you that manufacturing a SIPA is not easy. For Amarin, it took many years and many millions of dollars to build our reliable supply chain. Early on, our cost of goods sold for placebo capsules was much higher, but we lowered that cost through experience, investment, and volume. Along the way, we worked with many third-party suppliers. Some of which have succeeded in producing Visepa and remain our suppliers, and other companies which have failed. The manufacturing process involves multiple steps.

And it took many years in many millions of dollars to build our reliable supply chain for SEPA.

Early on our cost of goods sold four but super capsules was much higher but we lowered that costs through experience in investment and volume.

Along the way we work with many third party suppliers some of which have succeeded in producing for SEPA in remain our suppliers and other companies, which failed to produce for SEPA consistently beyond the pilot stage.

The manufacturing process involves multiple steps.

All of which need to be completed efficiently and cost effectively.

John Farrell: All of which need to be completed efficiently and cost-effectively. D-O-A-L, of the end product, is paramount. The active ingredient of a SEPA, if not stable and pure, is unlikely to have the same clinical effect as demonstrated by the high-quality product sold by AIMS. The Generic Company, if it intends to become large suppliers of a seatbelt, will have to demonstrate that they too can produce the SIPA consistently, with high quality and costs effectively at commercial scale. As we know, creating that capacity, including construction, testing, and qualification, is expensive and time-consuming. They may get there, but we don't expect it to be easy or inexpensive.

Moreover.

Quality stability and consistency of the end product is paramount.

The active ingredient SEPA, if not stable and pure is unlikely to have the same clinical effect as was demonstrated by the high quality product sold by Cameron.

The generic companies if they intend to become large suppliers up a super.

We'll have to demonstrate that they too can produce super consistently.

With high quality and cost effectively at commercial scale.

As we know reading that capacity, including construction testing and qualification is expensive and time consuming.

They may get there, but we don't expect it to be easy or inexpensive for them.

For these reasons the return on their investments from building manufacturing capacity for but SEPA is likely to be well below that of other generic drugs, where they can leverage existing infrastructure and expertise.

John Farrell: For these reasons, the return on their investment from building manufacturing capacity for Vasipa is likely to be well below that of other generic drugs where they can leverage existing infrastructure. In the early stages of producing Visepa, Amarin suppliers had significant challenges which they had to overcome.

In the early stages of producing the SEPA Cameron suppliers had significant challenges, which they had to overcome.

For Amarin.

Suppliers were interested in long term collaborations for a growing product.

John Farrell: Suppliers were interested in long-term collaborations for a growing product. This long-term growth opportunity motivated them to work with us and overcome these challenges. It also motivated them to make large capital investments to be rewarded with potential long-term global growth.

This long term growth opportunity motivated them work with us and overcome these challenges.

It also motivated them to make large capital investments to be rewarded with potential long term global growth of a SEPA with demand created by amarin.

John Farrell: SEPA with demand created by Amarin. Alternative potential future suppliers are unlikely to look at generics. Various suppliers have articulated to Amarin that they worry that the intention span of generic companies for individual products can be relatively short-lived, making generic companies less dependable and making capital investment by the suppliers in support of generic companies more difficult to justify. At this time, no generic version of the SIPA has been launched, and no pricing has yet been publicly listed for a generic version of the SIPA. Such public posting of a product price is a step required prior to the launch of any product, whether branded or generic.

[noise] alternative potential future suppliers are unlikely to look at generic companies in the same light.

Various suppliers have articulated to amarin that they worry that the attention span of generic companies to individual products can be relatively short lived making generic companies less dependable and making capital investment by the suppliers in support of generic companies more difficult to justify.

At this time no generic version of a Super has launched no pricing has yet been publicly listed for generic version of the SEPA.

[noise], such public posting or product prices they step required prior to the launch of any product with a branded or generic.

While it is possible that a generic version of the SEPA could be launched at any time.

John Farrell: While it is possible that a generic version of the SIPA could be launched at any time, currently, we do not anticipate a launch of a generic version of this until after the federal circuit has appealed. And then only if the generic companies win the appeal, and then only to the extent that the generic companies have qualified supply capacity, if they launch before the Federal Circuit decision. They would be doing so at risk of patent infringement damages owed to Amarin, which could be quite expensive to the generic companies if Amarin prevails against them. The Federal Circuit is likely to reach a decision in one of three categories.

Currently we do not anticipate launch of a generic version of the seatbelt until after the Federal Circuit appeal decision and then only up the generic companies when the appeal and then only to the extent that the generic companies have qualified supply capacity.

If they launched before the federal circuit decision.

They would be doing so at risk of patent infringement damages owed to amarin, which could be quite expensive to the generic companies if amarin prevails on appeal.

The federal circuit is likely to reach decision in one of three categories.

First the court could rule and Amarins favor.

John Farrell: First, the court could rule in Amarin's favor. Not surprisingly, we clearly think that this decision is the best and most appropriate. However, while we believe that we have good legal arguments... And that our patents should be upheld, and that we have a reasonable shot at winning, there is no way for us to guarantee that the Federal Circuit will rule in Amarin's favor.

Not surprisingly, we clearly think that this decision is the best in most appropriate decision.

However, while we believe that we have good legal arguments and that our pads should be upheld and that we have a reasonable shot at winning.

There is no way for us to guarantee that the federal circuit will decide and amarins favor.

Secondly.

John Farrell: The Federal Circuit could rule in favor of the generic companies and confirm the District Court decision. Such a decision would be disappointing on many levels. However, we recognize that such a decision is possible, as overturning a lower court ruling has not been easy in the industry historically. Or, thirdly, the Federal Circuit could remand the matter back to the District Court for reconsideration by the District Court based on guidance from the Federal Circuit regarding how to properly apply the law and or how to consider certain factors. We cannot predict which of these three decisions will be reached by the federal government.

The federal circuit rule in favor of the generic companies and confirm the district Court decision.

So that's a decision would be disappointing on many levels.

However, we recognize that such a decision is possible as overturning a lower court ruling has not been easy in the industry historically.

[noise] or thirdly, the federal circuit could remain the matter back to the district court for reconsideration by the District Court based on guidance from the federal circuit regarding how to properly apply the law and or how to consider certain facts.

We cannot predict which of these three decisions will be reached by the federal circuit.

We believe that we have strong legal arguments in a smart and experience legal team that will argue for us in the oral hearing.

John Farrell: We believe that we have strong legal arguments and a smart and experienced legal team that will argue for us in the oral hearing. However, as we saw in the district court decision, strong arguments and a strong team do not guarantee success if we lose at the Federal Circuit, and generic SIPA becomes available. We will assess at that time the degree to which we should continue to promote PASIPA in the United States. In such a scenario, we envision multiple potential pathways to further value creation from Visepa in the United States and internationally. Again, based upon information available to us today, if generics launch in the United States, it is our expectation that they will be launched with a limited supply. Well, we could, of course.

However, as we saw in the district Court decision strong arguments in a strong team do not guarantee success.

If we lose at the federal circuit.

Generic the seep up becomes available we will assess at that time, the degree to which we should continue to promote the SEPA in the United stage.

[noise] in such a scenario, we envision multiple potential pathways to further value creation from the SEPA in the United States and internationally.

Again based upon information available to us today, if generics launch the United States. It is our expectation that they would be launching with limited supply.

While we could of course counter the generic launch with our own authorized generic and leverage the manufacturing cost efficiencies, which we have developed over multiple years.

John Farrell: Counter their generic launch with our own authorized generic and leverage the manufacturing cost efficiencies which we have developed over multiple years. However, we believe that it is more likely that a significant portion of the market will remain branded for a considerable period of time. As a reminder, Vasepa is not a high-priced drug, particularly if generic companies have limited supply capacity. It would be unusual and somewhat nonsensical for them to sell a limited supply at a low price.

We believe that is more likely that a significant portion of the market will remain branded for a considerable period of time.

As a reminder, SEPA is not a high price drug.

Particularly if generic companies have limited supply capacity it would be unusual and somewhat nonsensical for them to sell limited supply at a low price.

Because of our belief that branded the SEPA will remain important in the United States and that the C., but it's early in its launch in the United States in has broad potential globally.

John Farrell: Because of our belief that branded Vasipa will remain important in the United States and that Vasipa is early in its launch in the United States and has broad potential globally, for the foreseeable future, Amarin intends to continue to purchase Vasipa supply at levels previously described. Modest Adjustment for the Hopefully Short-Lived Unfavorable Market Growth Impact of COVID-19. Similarly, as previously discussed,

For the foreseeable future Amarin intends to continue to purchase because he put supply at levels. Previously described with some modest adjustment for the hopefully short lived on favorable market growth impact of Cobot 19.

Similarly, as previously discussed because a generic version of the SEPA is unlikely to launch soon.

John Farrell: Because a generic version of FACIPA is unlikely to launch soon, and because generic companies are likely to have limited supply capacity for Visepo, even if they do win the federal circuit.

Because generic companies are likely to have limited supply capacity for but she book.

Even if they do when the federal circuit.

John Farrell: Commencing this quarter, as previously guided, Amarin is increasing promotion levels of Visepa in the United States. If we lose in the Federal Circuit Appeal, we will then assess whether we should further expand, contract, or maintain such levels of SEPA promotion in the United States. As our Chief Commercial Officer, Aaron Berg will discuss further. The market need and opportunity for Visepa in the United States remains high. And currently, most doctors and patients are unfamiliar with Vasiputrin. The ZIPA has been approved for cardiovascular risk reduction only since December.

Commencing this quarter as previously guided amarin is increasing promotion levels of SEPA in the United States.

If we lose in the federal Circuit appeal, we will assess then whether we should further expand.

Contract or maintain such levels of SEPA promotion in the United States.

As our Chief commercial officer, Aaron Berg will discuss further.

The market need an opportunity for vascepa in the United States remains high.

And currently most doctors and patients are unfamiliar with the SEPA.

The c., but has been approved for cardiovascular risk reduction only since December.

In addition.

John Farrell: In addition, many people who think that they understand Visepa have only superficial knowledge of this unique drug. We believe that we can help many patients. Grow Considerably Through Increased Promotion and Expansion. Our rate of growth in the near term is heavily impacted by COVID. Accordingly, I will now pivot our discussion from the Federal Circuit appeal to the discussion of Amarin's operation.

Many people think that they understand it was SEPA have only superficial knowledge of this unique drug.

We believe that we can help many patients and grow considerably through increased promotion and execution.

Our rate of growth in the near term is heavily impacted by cobot 19.

Accordingly.

I will now pivot our discussion from the federal circuit appeal to discussion or Amarins operations in this challenging and unprecedented cobot environment.

John Farrell: Challenging and Unprecedented COVID Environment. As you are likely aware, some companies have expressed concerns about declining revenues due to the impact of COVID-19. Amarin is pleased that its net total revenue in Q2 2020 of $135.3 million increased 34% over Q2 2019.

As you are likely aware some companies have expressed concerns about declining revenues due to the impact of covert 19.

Amort is pleased that net total revenue in Q2 2020 $135.3 million increased 34% over Q2 2019.

Our Q2 revenue growth was heavily impacted by cobot 19.

Aaron D. Berg: Our Q2 revenue growth was heavily impacted by COVID. While under the circumstances, we think that our reported growth is good, such growth is well below our goals and expectations if there were no COVID-19 pandemic. For further discussion of our Q2 results in the United States and our plans for re-accelerating growth, I turn the call over to Amarin's Chief Commercial Officer, Aaron Berg. Jono's absolutely right.

While under the circumstances, we think that our reported growth is good.

Such growth level is well below our goals and expectations. If there were no covert 19 pandemic.

For further discussion of our Q2 results in United States, and our plans for re accelerating growth.

I turn the call over to Amarins, Chief commercial officer.

Aaron Berg.

Good morning.

Oh, absolutely right.

While it is good we grew the c., but in the second quarter. Despite the impact from the covert 19 shutdown. We're seeing some early signs of market recovery and confident that we can achieve more in the future and we are inspired that we need to do more to improve patient care specifically in light of the covert 19 pandemic.

Aaron D. Berg: While it's good we grew Visepa in the second quarter, despite the impact of the COVID-19 shutdown, we're seeing some early signs of market recovery, and we are confident that we can achieve more in the future. And we are inspired that we need to do more to improve patient care. Specifically, in light of the COVID-19 pandemic and the demonstration that patients with underlying cardiovascular disease or risk factors, including diabetes, are more vulnerable to the virus, the need has never been greater for Vaseepa. As discussed on Amarin's last quarterly investor call, in Q1, we launched the new cardiovascular risk indication for Visepa, which included a newly expanded U.S. sales team of approximately 800 field sales representatives plus their managers to These efforts helped Visepa show strong, accelerating prescription and revenue growth in February and March. However, when the industry encountered the sudden and dramatic impact of the COVID-19 pandemic, the growth slowed, as is the case with many branded pharmaceuticals. April was a particularly challenging month.

The demonstration that patients with underlying cardiovascular disease or risk factors, including diabetes are more vulnerable to the virus. The need has never been greater for best SEPA.

As was discussed one amarins last quarterly Investor call in Q1, we lost the new cardiovascular risk indication from a SEPA, which included a newly expanded U.S. sales team to approximately 800 field sales representatives plus their managers to reach a broader base a relevant health care for stroke.

Diverse these efforts helps the Seapass show strong accelerating prescription and revenue growth in February and March however, when the industry encounter the sudden and dramatic impact on the covert 19 pandemic the growth slowed as is the case with many branded pharmaceuticals.

April was a particularly challenging month.

However, recently, we've been witnessing signs of recovery in various aspects of the market and our business specifically.

Aaron D. Berg: However, recently, we've been witnessing signs of recovery in various aspects of the market, and in our business specifically. And while recognizing that COVID-19 will continue to present significant headwinds for the foreseeable future, cardiovascular disease remains the number one killer of Americans, affecting millions of lives, and we intend to seize every opportunity to help these patients and reaccelerate our growth. During the height of the lockdown, reports from Acuvia indicated that patient visits to medical offices were down approximately 70% nationally.

And while recognizing that Cobiz 19 will continue to present significant headwinds for the foreseeable future cardiovascular disease remains the number one killer of Americans affecting millions of lives and we intend to seize every opportunity to help these patients and reach celebrate outgrowth.

During the height of the Lockdown reports from Acuvue indicated that patient visits to medical offices were down approximately 70% nationally.

Similarly, they reported the significant drop and the number of routine laboratory tests, including blood tests being conducted.

Aaron D. Berg: Similarly, they reported a significant drop in the number of routine laboratory tests, including blood tests, being conducted for a drug like vasepin to be prescribed for its cardiovascular risk reduction indication. Often, physicians examine these patients and obtain laboratory test results for measures including cholesterol, triglycerides, and other important biomarkers. The slowing of VSEPA revenue growth during the second quarter is not a reflection of reduced need for VSEPA but rather a reflection that many qualified patients didn't go to their doctors for routine preventive visits and blood work during the pandemic. On the contrary, we continue to hear very positive feedback regarding BCIPA from healthcare professionals and patients. As has been widely reported, providers and patients became understandably focused on the urgent issues of the deadly COVID-19 pandemic, and patients have become less inclined to seek medical care for less acute concerns. Creating a further challenge for VASIPA prescription growth was that we've historically focused on efficiently promoting VASIPA primarily in more concentrated geography. As a result, the SEPA volume is disproportionately high in areas such as New York City, Los Angeles, and other hotspots that were significantly affected by and closed down during much of Q2.

For a drug lymphoseek, but to be prescribed for its cardiovascular risk reduction indication.

Often physicians exam in these patients and obtain laboratory test results for measures, including cholesterol triglycerides and other important biomarkers.

The slowing of the Super revenue growth during the second quarter is not a reflection of reduce need for vascepa, but rather reflection that many qualified patients didn't go to their doctors for routine preventative visits and blood work toward the Pandemics [noise].

To the contrary, we continue to hear very positive feedback regarding the SEPA from health care professionals and patients.

As has been widely reported providers and patients became understandably focused on their urgent issues of the deadly Tobin 19, pandemic and patients have become less inclined to seek medical care for less acute concerns.

Creating further challenge for Vascepa prescription growth was that we've historically focused on officially promoting vascepa primarily in more concentrated geography.

As a result, let's see the volume is disproportionately high in areas, such as New York City, Los Angeles, and other hot spots that were significantly affected by in close down during much of Q2.

Aaron D. Berg: While challenges remain, some of these areas have started to reopen, and we will be opportunistic in pursuing growth wherever and as rapidly as possible. Starting in mid-March, when we initially suspended face-to-face interactions between our sales representatives and healthcare professionals, our aim has been to find innovative ways to maintain communication with SEPA prescribers and patients to provide the information and support they need. The actions of our sales and marketing teams have increasingly utilized virtual educational programs, including digital outlets, to engage healthcare providers less knowledgeable about Visepa's benefits, as well as maintain the continuum of care for patients already prescribed Visepa. Here, ironically, we found that some doctors were more engaged in learning about Vasipa's clinical results and actually took more time to ask questions as they may have been seeing fewer patients during Q2. However, as you'd expect, many healthcare professionals were focused on other critical matters and, as a result, were difficult to engage with during the height of the pandemic.

Well challenges remain some of these areas have started to reopen and we'll be opportunistic in pursuing growth wherever and as rapidly as possible.

[noise] starting in mid March when we initially suspended face to face interactions between our sales representatives in health care professionals. Our aim has been defined innovative ways to maintain communication with the super prescribers and patients to provide the information and support they need.

The actions of our sales and marketing teams have increasingly utilize virtual educational programs, including digital outlets to engage health care providers less knowledgeable about the seapass benefits as well as maintain the continuum of care for patients already prescribed the SEPA.

Here Ironically, we found that some doctors were more engaged and learning about the seapass clinical results and actually took more time to ask questions. As they may have been seeing fewer patients during Q2.

However, as you'd expect many health care professionals were focused on other critical matters and as a result were difficult to engage during the height of the pandemic.

We also use this time as an opportunity to continually train our field sales organization, many of whom joined US only months ago to better prepare them to be rapidly productive as direct face to face sales interactions we're re initiated.

Aaron D. Berg: We also use this time as an opportunity to continually train our field sales organization, many of whom joined us only months ago, to better prepare them to be rapidly productive as direct face-to-face sales interactions are reinitiated. Amarin is a data-driven company that cares about patient care and cares about our employees. Just as we believe that we were responsible in March, when we were one of the first companies to announce that we were suspending direct sales interactions with customers. In June, we began to test safely, getting some of our sales representatives back in front of healthcare professionals on a face-to-face basis in a manner consistent with CDC, state, and local regulations. During late June and further in July, we gradually increased the number of sales representatives who resumed direct sales interaction. Now, in early August, much of our sales force is in the field, with an ongoing learning curve regarding how best to interact with healthcare professionals in this very dynamic COVID-19 environment. Not all doctors currently and consistently allow sales representatives into their offices, and some areas of the country which started to open have closed again.

Amarin is a data driven company the cares about patient care and cares about our employees.

Just as we believed that we were responsible in March when we were one of the first companies to announced that we were suspending direct sales interactions with customers in June we began to test safely getting some of our sales representatives back in front of health care professionals on a face to face basis in a manner consistent with CDC.

Great and local regulations.

During late June and further in July we gradually increase the number of sales representatives, who have resumed direct sales interactions.

Now in early August much of our sales forces in the field with an ongoing learning curve regarding how best to interact with health care professionals in this very dynamic Cobiz 19 environment.

Not all doctors currently and consistently allow sales representatives into their offices.

In some areas of the country, which started to open have closed again.

We expect the need to continue to adapt to this environment and while our trx levels are above pre cobiz 19 levels. The productivity of our sales team remains slowed by covert 19 related challenges.

Aaron D. Berg: We expect the need to continue to adapt to this environment, and while our TRX levels are above pre-COVID-19 levels, the productivity of our sales team remains slowed by COVID-19-related challenges. We intend to remain flexible and responsible. Our priority is patient health. Given the persistent cardiovascular risk which exists in so many patients and the multiple adverse potential consequences of such risks, we need to ensure that their doctors are well aware of the demonstrated clinical profile and unique FDA-approved indication of SCP, and we're determined to capitalize as the market recovers. According to IQVIA data, patient visits to physicians increased considerably in June compared to the lows of April. However, while patient visits were higher in June than in April, they remained down approximately 34% compared to pre-COVID-19 levels. Similarly, the number of lab tests in June also remained well below pre-COVID-19 levels.

We intend to remain flexible and responsible our priority is patient health.

Given the persistent cardiovascular risk, which exists in so many patients and the multiple adverse potential consequences of such risks.

We need to ensure that their doctors are well aware of the demonstrated clinical profile and unique sta approved indication of the SEPA.

And were determined to capitalize as the market recovers. According to Q via data patient visits to physicians increased considerably in June compared to the lows of April.

However, while patient visits were higher in June that then in April they remain down approximately 34% compared to pre Tobin 19 levels.

Similarly.

The number of lab tests in June also remained well below pre cobot 19 levels.

This third party industry data reflects continued patient fear in apprehension.

Aaron D. Berg: This third-party industry data reflects continued patient fear and apprehension. While such cautiousness is understandable, patients with high cardiovascular risk appear to be at increased risk of complications from COVID-19, which further points to the increasing importance of preventive cardiovascular care. We still have a long way to go in re-accelerating and maximizing vesipa growth, but we're confident and determined to make it happen. Salesforce morale is high, turnover low, and representatives are excited to be out in the field talking about Visepa. We will no doubt continue to face COVID-19-related challenges, but we will continue to do what we believe is best for patient care and for our employees. Regarding Visepa results in Q2, based on monthly U.S. data provided by third parties, Symphony Health and IQVIA, the estimated number of normalized total Visepa prescriptions for the three months ended June 30, 2020, compared with the same period in 2019, increased 44% and 47%, respectively. Normalized total prescriptions represent the estimated total number of SEPA prescriptions dispensed to patients calculated on a normalized basis. For example, one month's supply or total capsules dispensed multiplied by the number of grams per capsule divided by 120 grams.

While such cautiousness is understandable patience with high cardiovascular risk appear to be at increased risk of complications from Cobiz 19, which further points to the increasing importance of preventive cardiovascular care.

We still have a long way to go and Reaccelerating in maximizing the super growth, but we're confident and determined to make it happen.

Salesforce morale is high turnover low and representatives are excited to be out in the field talking about the SEPA.

Well no doubt continued to face Cobiz 19 related challenges.

Well, we will continue to do what we believe is best for patient care and for our employees.

Regarding the SEPA results in Q2 based on monthly U.S. data provided by third parties Symphony Health and I can give you. The estimated number of normalized total super prescriptions for the three months ended June Thirtyth 2020, compared with the same period in 2019 increased 44% and 40.

The 7% respectively.

Normalized total prescriptions represent the estimated total number of the Super prescriptions dispensed to patients calculated on a normalized basis. For example, one month supply or total capsules dispensed multiplied by the number of grams per capsule divided by 120 grams.

Based on data available to us, let's see but inventory levels at wholesalers were within the normal industry range at the beginning and end of Q2 2020.

While it's difficult to predict the rate at which society will reopen from Kobin 19.

The patient needs from a super remains high.

Aaron D. Berg: Based on data available to us, the SIPA inventory levels at wholesalers were within the normal industry range at the beginning and end of Q2 2020. While it's difficult to predict the rate at which society will reopen from COVID-19, The patient need for Vasepa remains high, yet awareness of Vasepa is low, and with no direct competition. Prescription growth appears to be very sensitive to generating educated awareness of the clinical benefits of Visepa among key health care professionals and patients. We need to continue to seize this opportunity for the benefit of patient care. Remember that the Vasepa Cardiovascular Risk Reduction Indication was approved by the FDA just this past December, and without education by Amarin, many doctors wouldn't have learned about it. Continued consumer and healthcare professional-focused education remains a top priority for our business, as there is sufficient need to increase awareness of El Vecipo. During a recent awareness study among about 300 randomly selected cardiologists, endocrinologists, and primary care physicians, unaided awareness of the SEPA for cardiovascular risk reduction was just 32%. Among 302 statin-treated consumers with triglycerides above 150, unaided awareness was less than 1%.

Awareness of the SEPA is low and with no direct competition.

[noise] prescription growth appears to be very sensitive to generating educated awareness of the clinical benefits of the SEPA with key health care professionals and patients.

We need to continue to seize this opportunity for the benefit of patient care.

Remember that the SEPA cardiovascular risk reduction indication was approved by the FDA. Just this past December and without education by Amarins, many doctors won't learn about it.

[noise] continued consumer and health care professionals focused education remain a top priority for our business.

Is there a sufficient need to increase awareness about the SEPA.

Very recent awareness study among about 300 randomly selected.

Cardiologists endocrinologists and primary care physicians unaided awareness of the SEPA for cardiovascular risk reduction was just 32%.

Among 302 stat untreated consumers with triglycerides above 150, unaided awareness was less than 1%.

While the SEPA awareness is higher among doctors directly called upon by our sales team even for most of those doctors continue education increased awareness is important.

To augment our ongoing activities to educate healthcare professionals via the Salesforce and other initiatives in mid July we launched our first ever direct to consumer campaign for Vascepa focused on the use of the SEPA for cardiovascular risk reduction with emphasis that the SEPA is the first and only product approved.

Aaron D. Berg: While VACIPA awareness is higher among doctors directly called upon by our sales team, even for most of those doctors, continued education and increased awareness are important. To augment our ongoing activities to educate healthcare professionals via the sales force and other initiatives, in mid-July, we launched our first-ever direct-to-consumer campaign for Visepa focused on the use of Visepa for cardiovascular risk reduction, with emphasis that Visepa is the first and only product approved for its cardiovascular risk reduction indication. The new promotional campaign focuses on persistent cardiovascular risk and the benefit of a SEPA to reduce the risk of a heart attack or stroke by 25% when added to a statin. The campaign, which is intended for patients and healthcare professionals, encourages patients to ask their doctors about CBC. Per FDA regulation, promotion of drugs must include a fair balance of information about drug risk.

Move for its cardiovascular risk reduction indication.

The new promotional campaign focuses on persistent cardiovascular risk and the benefit of the sequel to reduce risk of a heart attack or stroke by 25% when added to a stat.

The campaign, which is intended for patients and health care professionals encourages patients to ask their doctors above the SEPA.

Perhaps the regulation promotional drugs must include fair balance of information about drug risks in the span of our 62nd TV has we wanted to make sure that we communicated some key points, including 25% risk reduction and first and only drug with this important new indication to.

Makes such claims we need to include see discussion in a manner, which will be understood by patients and consistent with FDA feedback and labeling.

Hopefully it will be clear to most people not for F. D to approve the c., but for this important new indication the benefits are deemed to outweigh the risks.

At a minimum we're hoping that the as get doctors to think more above as people get patients to ask their doctors about this evil.

The c., but is used to treat high risk patients was studied over an extended period of time and as per medical publications. The SEPA was well tolerated in safe.

The 25% risk reduction on top of standard therapy is unparalleled and as a result, many medical societies recommend the seem to be used to effectively treat appropriate at risk patients.

Aaron D. Berg: In the span of our 60-second TV ad, we wanted to make sure that we communicated some key points, including 25% risk reduction and the first and only drug with this important new indication. To make such claims, we need to include safety discussions in a manner that will be understood by patients and consistent with FDA feedback and labeling. Hopefully, it will be clear to most people that for FDA to approve SEPA for this important new indication, the benefits are deemed to outweigh the risks. At a minimum, we're hoping that the ads get doctors to think more about Visepa and get patients to ask their doctors about Visepa. The SEPA is used to treat high-risk patients, and it was studied over an extended period of time, and, as per medical publications, the SEPA was well-tolerated and safe.

Hopefully more patients what asked a doctor's office SEPA as we increase awareness.

This new campaign as many components, including a national TV schedule, social media channels, such as Facebook, Instagram and you too and other forms of outreach and education includes increased visibility and Tele medicine and these components are being rolled out over the course of Q3 and beyond into stage manner.

Such communications emphasized the C., but is the first and only drugs, which is ft. A proof for this years.

Is that when expressed previously we understand that the investment in such promotion is not inexpensive, but we believe that the result may help improve patient care for potentially millions of people and that the cost of such promotion will be covered by growth in the super revenues.

Historically for other products brand perception and recognition evolves as people see such promotion multiple times, we hope and expect from a super promotion and education to be both significant and sustained over an extended period of time.

Aaron D. Berg: The 25% risk reduction on top of statin therapy is unparalleled, and as a result, many medical societies recommend that Visepa be used to effectively treat appropriate at-risk patients. Hopefully, more patients will ask their doctors about Visepa as we increase awareness. This new campaign has many components, including a national TV schedule, social media channels such as Facebook, Instagram, and YouTube, and other forms of outreach and education, including increased visibility in telemedicine, and these components are being rolled out over the course of Q3 and beyond in a staged manner. Such communications emphasize that SEPA is the first and only drug which is FDA approved for this use. As Amarin has expressed previously, we understand that the investment in such promotion is not inexpensive, but we believe that the result may help improve patient care for potentially millions of people and that the cost of such promotion will be covered by growth in SEPA revenue. Historically, for other products, brand perception and recognition evolve as people see such promotion multiple times.

For society savings from effective preventative care come from fewer high cost heart attacks strokes and other cardiovascular events, which also helps keep patients and their families productive.

In tandem to our awareness campaign, we're also investing and improve patient access and reimbursement from payers.

Our managed care coverage has been improving as managed care plans increasingly learn about the recent FDA approved indication and recognize the value of the SEPA.

As we've described previously the SEPA is on formulary for the vast majority payers and we've been working to improve access and reduce out of pocket costs and restrictions for patients by improving formulary positioning to preferred tier status.

During 2020, some payers that were previous outliers and didn't cover or restricted the SEPA improved access as many elevated but SEPA to preferred tier status.

Some holdouts remain but more than three quarters of insured lives on commercial insurance plans are now with payers that have the SEPA on their preferred tier.

Aaron D. Berg: We hope and expect Vesepa promotion and education to be both significant and sustained over an extended period of time. For society, savings from effective preventative care come from fewer high-cost heart attacks, strokes, and other cardiovascular events, which also helps keep patients and their families productive. In tandem to our awareness campaign, we're also investing in improved patient access and reimbursement for payers. Our managed care coverage has been improving as managed care plans increasingly learn about the recent FDA-approved indication and recognize the value of this sequence. As we've described previously, SEPA is on formulary for the vast majority of payers, and we've been working to improve access and reduce out-of-pocket costs and restrictions for patients by improving formulary positioning to preferred tier status.

Some of this improved coverage occurred in Q1 in Q2 of this year with some additional improved coverage becoming effective starting in July.

It's reassuring to witness the value of the seep of being increasingly recognized by these payers. Some of this has been aided by patients and health care professionals, emphasizing the need for a secret to be covered.

Such support helps and we're thankful to everyone.

Reached out to payers to ensure that the SEPA is readily available and affordable to all patients who need it.

Overall, while the impact of the Kobin 19, pandemics to the launch of the best SEPA cardiovascular risk indication and to the industry as a whole has been significant we're hopeful the modest yet encouraging early signs of recovery continue.

Thus far one of the most encouraging signs of recovery. The recent accelerated prescription growth in our target physicians in particular cardiologists.

We're increasingly committed to reaccelerate of a super growth during the balance of 2020 M. beyond we anticipate continued challenges and unpredictable recovery from Kobin 19, and can't predict with accuracy, how rapidly will grow.

Aaron D. Berg: During 2020, some payers that were previous outliers and didn't cover or restricted VISIPA improved access, as many elevated VISIPA to preferred tier status. Some holdouts remain, but more than three-quarters of insured lives on commercial insurance plans are now with payers that have Visepa on their preferred tier. Some of this improved coverage occurred in Q1 and Q2 of this year, with some additional improved coverage becoming effective starting in

However, we know we have a significant opportunity are confident that we have the product the people and the resources to be successful and fully intend to maximize this opportunity for the benefit of patient care and our shareholders.

Huh.

Thank you Aaron for those helpful comments and perspectives I too am confident that we will succeed in reaccelerating procedure growth in the United States.

Echoing your comments about people at high risk for adverse cardiovascular events, not getting much needed medical care, resulting an unnecessary medical issues.

Aaron D. Berg: It's reassuring to witness the value of Visepa being increasingly recognized by these payers. Some of this has been aided by patients and healthcare professionals emphasizing the need for Visepa to be covered. Such support helps, and we're thankful to everyone who's reached out to payers to ensure that SEPA is readily available and affordable to all patients who need it.

Including unnecessary deaths.

And analysis published in July by the Washington Post suggested that in five hard hit States in New York City.

There were 8300 more deaths from heart problems than would have been typical in March April and May.

Aaron D. Berg: Overall, while the impact of the COVID-19 pandemic on the launch of the VACIPA cardiovascular risk indication and on the industry as a whole has been significant, we're hopeful the modest yet encouraging early signs of recovery will continue. Thus far, one of the most encouraging signs of recovery is the recent accelerated prescription growth among our target physicians, in particular cardiologists. We're increasingly committed to reaccelerating VISIPA growth during the balance of 2020 and beyond. We anticipate continued challenges and unpredictable recovery from COVID-19 and can't predict with accuracy how rapidly we'll grow. However, we know we have a significant opportunity, are confident that we have the product, the people, and the resources to be successful, and fully intend to maximize this opportunity for the benefit of patient care and our shareholders. John.

An increase of roughly 27% over historical averages.

While several expert said some of the excess deaths in the analysis, we're almost certainly unrecognized fatalities from covert 19.

The reviews suggests that many patients suffering from serious conditions died as a result of delaying or not seeking care at the outbreak progressed and swamp some hospitals.

The data further highlights the need for preventative cardiovascular care and proven effective therapies.

We are hopeful that people will start to more aggressively seek out care for their cardiovascular issues.

In light of the covert pandemic.

And the demonstration that patients with persistent cardiovascular risk are more vulnerable to the virus.

And the great cost to patients and society from strokes heart attacks other major adverse cardiovascular events as the SEPA has been demonstrated to reduce.

John Farrell: Thank you, Aaron, for those helpful comments and perspectives. I, too, am confident that we will succeed in re-accelerating BCEPA growth in the United States. Echoing your comments about people at high risk for adverse cardiovascular events not getting much needed medical care, resulting in unnecessary medical issues, including Unnecessary Death. An analysis published in July by the Washington Post suggested that in five hard-hit states in New York City...

The need has never been greater purpose SEPA.

Outside the United States, There's also significant opportunity for SEPA.

In Canada in February the seep was launched by our commercial partner HLS Therapeutics.

In China before the end of this year, we anticipate results to become public.

The SEPA clinical trial being conducted their by our partner.

In Europe, we're giving priority to getting the seep approved which approval we fall by plans for seeking reimbursement.

John Farrell: There were 8,300 more deaths from heart problems than would have been typical in March, April, and May, an increase of roughly 27% over a historical average. While several experts said some of the excess deaths in the analysis were almost certainly unrecognized fatalities from COVID-19, the review suggests that many patients suffering from serious conditions died as a result of delaying or not seeking care as the outbreak progressed. The data further highlights the need for preventative cardiovascular care and proven effective therapies. We are hopeful that people will start to be more aggressive. Seek out care for their cardiovascular issues.

And commercial growth.

And after we get going in Europe, we will further consider options for accelerating expansion of a SEPA into other parts of the world.

Turning now to a discussion of our plans in Europe, where our top priorities include regulatory approval country by country reimbursement and successful commercial launch.

As was the case in the United States in Canada.

The SEPA review by the European Medicines agency or you may is comprehensive.

We believe that we have a good responses to the questions that they've asked thus far and that we've not seen any red flags.

John Farrell: In light of the COVID pandemic and the demonstration that patients with persistent cardiovascular risk are more vulnerable to the virus, and the great cost to patients and society from strokes, heart attacks, and other major adverse cardiovascular events, as vasepa has been demonstrated to reduce, the need has never been greater for PCP. Outside the United States, there is also significant opportunity for placebo. In Canada, in February, Viseep was launched by our commercial partner, HLS Therapeutics. In China, before the end of this year, we anticipate results from the Visepa clinical trial being conducted there by our partners to become public. In Europe, we are giving priority to getting Visepa approved, which approval will be followed by plans for seeking reimbursement, and Commercial Growth. And after we get going in Europe, we will further consider options for accelerating the expansion of Visepa into other parts of the world. Turning now to a discussion of our plans in Europe, where our top priorities include regulatory approval, country-by-country reimbursement, and successful commercial launch. As was the case in the United States and Canada,

Questions being asked are typical for products, such as but SEPA.

We plan to continue to work diligently to respond to potential additional questions as they arise during this review process.

Assuming the M- completes its review and recommends approval of a super.

Such recommendation is typically properly followed by product approval by the European Commission.

The he May review process appears to have incurred some modest impact from covert 19.

But generally remains on track to support an anticipated favorable recommendation by you may followed by product approval by the European Commission.

Currently anticipated in early 2021.

As we approach anticipated regulatory approval of a SEPA in Europe.

Are you spent this year further evaluating options for vis SEPA commercialization in Europe.

Such a valuation included weighing the benefits and cost between engaging a large pharmaceutical partner or retaining the commercial rights in launching for seep on our own at least in larger countries of Europe.

John Farrell: The Visepa Review by the European Medicines Agency, or EMA, is comprehensive. We believe that we have good responses to the questions that they have asked thus far and that we have not seen any red flags. The questions being asked are typical for a product such as Visepa. We plan to continue to work diligently to respond to potential additional questions as they arise during this review process. Assuming the EMA completes its review and recommends approval of the product, such recommendation is typically promptly followed by product approval by the European Commission. The EMA review process appears to have encouraged some modest impact from COVID but generally remains on track to support an anticipated favorable recommendation by the EMA, followed by product approval by the European Commission. Currently, it is anticipated in early 2021.

In parallel with this evaluation, we have been building awareness for Vascepa and its cardiovascular risk reduction benefits among the cardiovascular medical societies and thought leaders in Europe.

As you May recall was not yet approved for sale in Europe.

The SEPA has already been included in the medical treatment guidelines of the European Society of Cardiology, and the European Atherosclerosis Society.

In addition, we have been conducting market analysis and payer access research in order to size the market opportunity and prepare for anticipated reimbursement negotiations in various countries within Europe.

Importantly, our intention under any commercialization scenario.

Was to manage to supply chain for vis EWP and Europe, and we have been working behind the scenes on these logistics.

John Farrell: As we approach anticipated regulatory approval of a SIPA in Europe, we have spent this year further evaluating options for Visepa commercialization in Europe. Such an evaluation included weighing the benefits and costs of engaging a large pharmaceutical partner or retaining the commercial rights and launching Viseep on our own, at least in the larger countries of Europe. In parallel with this evaluation, we have been building awareness for Vasepa and its cardiovascular risk reduction benefits among cardiovascular medical societies and thought leaders in Europe. As you may recall, while not yet approved for sale in Europe, FACEPA has already been included in the Medical Treatment Guidelines of the European Society of Cardiology and the European Atherosclerosis Society.

But SEPA represents a potential multibillion dollar opportunity in Europe.

3.9 million Europeans die annually of cardiovascular disease, representing approximately 45% of all death.

And over 80 million Europeans have cardiovascular disease.

Recent survey showed that about 25% of a representative sample of more than 7100 patients and 27 European countries with coronary heart disease uncontrolled LDL cholesterol levels had elevated triglyceride levels greater than 150 Megs per deciliter.

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

John Farrell: In addition, we have been conducting market analysis and Payor Access Research in order to size the market opportunity and prepare for anticipated reimbursement negotiations. Various Countries Within Europe Importantly, our intention under any commercialization scenario was to manage the supply chain for Visepa in Europe, and we have been working behind the scenes on this logistics. FACIPA represents a potential multi-billion dollar opportunity in Europe. 3.9 million Europeans die annually of cardiovascular disease, representing approximately 45% of all deaths, and over 80 million Europeans have cardiovascular disease. A recent survey showed that about 25% of a representative sample of more than 7,800 patients had coronary heart disease. Controlled LDL cholesterol levels had elevated triglyceride levels greater than 150 mg per deciliter, illustrating the potential pervasiveness of high-risk cardiovascular diseases in Europe beyond currently available therapy.

Given the enormity of this opportunity.

We have been working with many advisors regarding how best to commercialize and maximize shareholder value with the c., but in Europe.

We reviewed multiple proposals from pharmaceutical companies that wanted to commercialize proceed but in Europe.

Our reviews included analysis of the economic terms potential product penetration that priority that people might get in promotion by such companies versus amarin doing it ourselves and whether at third party would fight as hard or convincingly purpose seapass reimbursement in Europe.

These decisions also impact pricing of the SEPA in other geographies in other potential future strategic opportunities for amarin.

Investors, who shared their opinions with amarin almost unanimously expressed support for amarin retaining rights to the steep in Europe and less the deal terms for your we're in what some called up no brainer or what other called the too good to be true category.

John Farrell: Given the enormity of this opportunity, we have been working with many advisors regarding how best to commercialize and maximize shareholder value with the SIPA in Europe. We reviewed multiple proposals from pharmaceutical companies that wanted to commercialize Visepa in Europe. Our reviews included analysis of the economic terms. Potential product penetration, the priority that Visepa might get in promotion by such companies versus Amarin, doing it ourselves, and whether a third party would fight as hard or convincingly for Visepa's reimbursement in Europe. These decisions also impact pricing of Visepa in other geographies and other potential future strategic opportunities for America. Investors who shared their opinions with Amarin almost unanimously expressed support for Amarin retaining rights.

As we announced in a separate press release today, we have concluded that the best path forward for our shareholders is for us to retain the full upside potential of a seep into Europe and to not split such economics of this opportunity in Europe with another pharmaceutical company.

Rather we are confident that we have the ability to create greater value by launching for c., but in Europe through an amarin team.

This approach ensures that the team, which best knows the science and clinical results from the SEPA.

Our leading and seeking reimbursement on a country by country basis for this important product.

And similarly, this approach ensures that the seat, but get the highest level of priority from sales representatives and promotion.

[noise], while proposals from other companies to partner with Amarin for commercialization of a c., but in Europe, we're thoughtful.

John Farrell: SEPA in Europe unless the deal terms for Europe were in what some called the no-brainer category or what others called the too-good-to-be-true category. As we announced in a separate press release today, we have concluded that the best path forward for our shareholders is for us to retain the full upside potential of the SIPA in Europe. Do not split such an economic opportunity in Europe with another pharmaceutical company. Rather, we are confident that we have the ability to create greater value by launching FACIPA in Europe through Amarin. This approach ensures that the team who best knows the science and clinical results from BCIPA is leading in seeking reimbursement on a country-by-country basis for this important product. And, similarly, this approach ensures that PASIPA gets the highest level of priority from sales representatives and promotion.

In the end we concluded that it is important to ensure that we not run the risk of the focus on for SEPA getting diluted by other products promoted by such companies.

And that is important for amarin to preserve optionality for potential future strategic opportunities.

Our plan for commercial launch in Europe is to develop the foundation of our commercial team using similar principles to what we did in the United States.

We are hiring professionals and key roles and leveraging third party relationships for various support activities.

This may include local partners.

When it makes sense in certain smaller markets.

Launching on our own will result in a tight focus on the largest markets in Europe. We believe that Amarins current financial resources are adequate to properly launch SEPA in Europe.

John Farrell: While proposals from other companies to partner with Amarin for the commercialization of Visepa in Europe were thought, in the end, we concluded that it is important to ensure that the focus on FACEPA gets diluted by other products promoted by such companies and that it is important for Amarin to preserve optionality for potential future strategic opportunities. Our plan for the commercial launch in Europe is to develop the foundation of our commercial business, using similar principles to what we did in the United States. We are hiring professionals in key roles and leveraging third-party relationships for various support activities, may include local, when it makes sense in certain smaller markets. Launching on our own will result in a tight focus on the largest market.

To further prepare for the successful launch of a steep in Europe.

We recently hired a head of commercial for Europe, including sales market access and marketing.

We're very pleased to welcome Mr.

Raquel to the Amarin team.

Current joins amarin within impressive pedigree, including decades or relevant experience.

Proven track record launch in cardiovascular products in Europe.

Obviously for example, Crumb launch a set of eyes in France, and was Burks head of global cardiovascular products, a 4 billion dollar enterprise.

[noise] chrome brings to amortize wrong network of contacts and extensive European experience, including pricing and payer access expertise.

Importantly, then shares our excitement and vision for with people and its potential in Europe.

John Farrell: We believe that Amarin's current financial resources are adequate to properly launch the SEPA in Europe. [inaudible] Successful launch of ASEIP in Europe. We recently hired a head of commercial for Europe. Including sales, market access, and mark, We are very pleased to welcome Mr. Karim Mikhal to the embassy.

We have informed companies that expressed interest in for SEPA rights in Europe.

We appreciate their interest but are no longer pursuing a partner for the SEPA in Europe.

John Farrell: Crim joins Amarin with an impressive pedigree, including decades of relevant experience and a proven track record of launching cardiovascular products in Europe. Previously, for example, he launched Azetamide in France and was Merck's head of global cardiovascular products. $4 billion enterprise. Amarin Corp brings to Amarin a strong network of contacts and extensive European experience, as well as payer access. Importantly, Grimm shares our excitement and vision for Visepa and its potential in Europe. We have informed companies that expressed interest in Visepa rights in Europe that we appreciate their interest but are no longer pursuing a partner for Visepa in Europe. Due to the confidential nature of such partnering interactions, we cannot share with you the details of the proposals we received.

Due to the confidential nature of such partnering interactions we cannot share with you details of proposals we received.

Other than to say that there was sincere interest and that proposals gave us plenty to think about but the proposals clearly we're not of the oak described by shareholders as no brainers or too good to be true.

Building off the work that we've already done to build awareness for the Sip in Europe and seek regulatory approval, we are pursuing plans for Europe, which emphasize efficiency and productivity.

Our measure is not to maximize revenue, but rather to maximize value per share.

We believe that we can best do this through focus and emphasis that quality with high productivity is more cost effective than throwing a lot of money at the opportunity, particularly before the product has established reimbursement in large countries in Europe.

Please do not misinterpret my comments about being cost effective to suggest that we do not intend to be serious we believe that this is a very large market opportunity.

John Farrell: Other than to say that there was sincere interest, the proposals gave us plenty to think about, but the proposals clearly were not of the ilk described by shareholders as no-brainers or too good to be true. Building off the work that we've already done to build awareness for Visepa in Europe, Regulatory Approval. We are pursuing plans for Europe that emphasize efficiency and productivity. Our measure is not to maximize revenue but rather to maximize value per share.

We intend to address it robustly, but smartly.

Similar to what we do in the United States, we're hiring people into key roles and leveraging third party relationships for various board activities, which exist elsewhere and are not essential for us to recreate.

Paramus heading our European commercial team.

We have experienced people.

And our team to provide them support and we are confident in our plans to expand the core team to focus further on product reimbursement and launch plans.

John Farrell: We believe that we can best do this through focus and emphasis that quality with high productivity is more cost effective than throwing a lot of money at the opportunity, particularly before the product has established reimbursement in large countries in Europe. Please do not misinterpret my comments about being cost-effective to suggest that we do not intend to be serious. We believe that this is a very large market opportunity. We intend to address it robustly but smartly. Similar to what we did in the United States, we are hiring people into key roles and leveraging third-party relations for various sports activities which exist elsewhere and are not essential for us to recreate. Karim is heading our European commercial.

Based upon feedback thus far we're confident that we will find additional highly experienced people as needed.

[noise] market access is key to the success of any product in Europe.

Continuing to build medical support for Vascepa in Europe should be helpful towards gaining reimbursement for the SEPA.

After but seep is approved in this reimbursement process is further advanced.

We hope to be in a better positioned to comment on the timing of such reimbursement.

Given that no other product has the clinical results demonstrated by the SEPA. We are optimistic that we can achieve appropriate reimbursement for the SEPA in a timely manner in most countries of Europe.

John Farrell: We have experienced people and our team to provide him support, and we are confident in our plans to expand the core, Focus Further on Product Reimbursement and Launch. Based upon feedback thus far, we are confident that we will find additional highly experienced people as needed. Market access is key to the success of any product. Continuing to build medical support for Visepa in Europe.

Related Lee Amarin recently received its first new patent allowance for cardiovascular risk reduction.

With use of for SEPA in Europe.

As previously discussed European regulatory approval of a c., but as a new active substance should provide market exclusivity into 2031.

John Farrell: Be Helpful Towards Gaining Reimbursement for Visitors, after FISIPA is approved in this reimbursement process, is further advanced. We hope to be in a better position to comment on the timing of such reimbursement. Given that no other product has the clinical results demonstrated by Visepa, we are optimistic that we can achieve appropriate reimbursement for Visepa in a timely manner in most countries of Europe. Relatedly, Amarin recently received its first new patent allowance for cardiovascular risk reduction with the use of PASIPA in Europe.

This new patent should extend that exclusivity through 2033.

We have additional patent applications being prosecuted for Europe, which could potentially extend for SEPA patent protection Europe into 2039.

These potential additional six years could be quite valuable.

Pertaining to building medical awareness of asleep and Europe.

Amorous importing multiple scientific presentations at the European Society of Cardiology or E. S. C meeting from August 29 to September Onest.

John Farrell: As previously discussed, European regulatory approval of Visepa as a new active substance should provide market exclusivity into 2031. This new patent should extend that exclusivity through 2033. We have additional patent applications being prosecuted for Europe, which could potentially extend Visepa patent protection in Europe into 2039. These potential additional six years could be quite valuable.

The meeting which is being conducted virtually is the largest cardiology society meeting in the world with potentially of tens of thousands of participants.

This year's meeting has no registration fee and provides an opportunity to further showcase data regarding the SEPA.

One of the presentations accepted as a late breaker idiocy his presentation to the final evaporate clinical trial results.

As many of you know the evaporate clinical trial use imaging to evaluate the effects of the SEPA as an adjunct his dad therapy on plaque build up in human arteries as his characteristic in patients with high persistent cardiovascular risk factors.

John Farrell: Amarin is supporting multiple scientific presentations at the European Society of Cardiology, or ESC, meeting from August 29 to September 1. The meeting, which is being conducted virtually, is the largest cardiology society meeting in the world, with potentially tens of thousands of participants. This year's meeting has no registration and provides an opportunity to further showcase data regarding One of the presentations accepted as a late breaker at ESC is the presentation of the final evaporate clinical trial results. As many of you know, the EVAPORATE clinical trial used imaging to evaluate the effects of vasepa as an adjunct to statin therapy on plaque buildup in human arteries, as is characteristic in patients with high persistent cardiovascular risk factors. The interim results, based on scans at nine months, were presented at the 2019 AHA meeting and were recently published. The interim results were encouraging regarding limiting plaque buildup and potential plaque regression.

The interim results based on scans at nine months were presented at the 2019 Ha meeting and were recently published.

The interim results were encouraging regarding limiting plaque build up and potential plaque regression.

We look forward to hearing the final results of evaporate idiocy as well as other data being presented at this meeting.

As mentioned in our last Investor Conference call. We are in the early stages of exploring whether SEPA can help reduce covert 19 risk or mitigate the severity of cobot 19 infections.

Scientific leaders and Cameron believed that the Seapass established safety and efficacy profile and potential anti inflammatory anti thrombotic and they'll still feel and enter a viral effect could be useful to altering the natural history of covert 19.

We are hopeful that for SEPA can be useful to help people avoid the complications that can come from this terrible virus.

John Farrell: We look forward to hearing the final results of Evaporate at ESC, as well as other data being presented at this meeting. As mentioned in our last investor conference call, we are in the early stages of exploring whether PASIPA can help reduce COVID-19 risk or mitigate the severity of COVID-19 infection. Scientific leaders at Amarin believe that VACIPA's established safety and efficacy profile and potential anti-inflammatory, anti-thrombotic, endothelial, and antiviral effects could be useful in altering the natural history of COVID-19.

We have moved beyond the theoretical and into clinical testing.

Some information regarding such studies is available on clinical trials Dot Gov.

Well, we see a good scientific rationale for such studies and until we have data from such studies, we don't intend to comment in detail in the studies or to predict the results of such studies, where the level of additional study which might be needed. If these pilot studies are successful.

[noise] Amarin remains active in advancing the science around with SEPA.

John Farrell: We are hopeful that PASIPA can be useful to help people avoid the complications that can come from this terrible virus. We have moved beyond the theoretical and into clinical testing. Some information regarding such studies is available on clinicaltrials.gov.

Even prior to the upcoming scientific presentations that he is see amarin. This year is already supported more than 35 scientific publications are presentations pertaining to the SEPA and its unique active ingredient.

And the demonstrated positive clinical effect.

Our chief financial Officer by Cob, well now comment on our financial performance Mike.

John Farrell: Well, we see a good scientific rationale for such studies, but until we have data from such studies, we don't intend to comment in detail on these studies or to predict the results of such studies or the level of additional study which might be needed if these pilot studies are successful. Amarin remains active in advancing the science around Wasipa. Even prior to the upcoming scientific presentations at ESC, Amarin this year has already supported more than 35 scientific publications or presentations. SEPA and its unique active ingredients

Thanks, John.

I'm encouraged by our financial performance during the first half in 2020, as we recorded total revenue of $290.3 million and 67% increase compared with the first six months in 2019.

We were able to to achieve this growth despite the headwinds from the corporate 19 pandemic.

As a reminder, amarin recognizes product revenue in the United States based on sales to wholesalers and specialty pharmacy providers in the U.S. or collectively that's distributors or its customers in accordance with generally accepted accounting principles and not based on prescription levels reported by Symphony health or acute.

Michael Kalb: Demonstrated positive clinical effect. Our Chief Financial Officer, Mike Cobb, will now comment on our financial performance. Thanks, John. I'm encouraged by our financial performance during the first half of 2020, as we recorded total revenue of $290.3 million, a 67% increase compared with the first six months of 2019. And we were able to achieve this growth despite the headwinds from the COVID-19 pandemic. As a reminder, Amarin recognizes product revenue in the United States based on sales to wholesalers and specialty pharmacy providers in the U.S. or collectively, its distributors, or its customers in accordance with generally accepted accounting principles and not based on prescription levels reported by Symphony Health or IQ.

During the second quarter of 2020, we reported net product revenue of $133.7 million, 33% increase compared with the second quarter of 2019, and we achieved $285.9 million and net product revenue for the first six months for 2020.

Representing a 65% increase compared with the same period in 2019.

These increases were largely driven by increased U.S. must keep ourselves as well as a modest increase in the seapass net selling price in the United States, which reflects some of the managed care coverage improvements that arent spoke about earlier.

Michael Kalb: During the second quarter of 2020, we reported net product revenue of $133.7 million, a 33% increase compared with the second quarter of 2019, and we achieved $285.9 million in net product revenue for the first six months of 2020, representing a 65% increase compared with the same period in 2019. These increases were largely driven by increased U.S. Visepa sales as well as a modest increase in Visepa's net selling price in the United States, which reflects some of the managed care coverage improvements that Aaron spoke about earlier. Amarin continues to maintain strong gross margins with an overall gross margin on net product revenue of approximately 78% for the first half of the year. This slight increase compared to the same period in 2019 is driven by gross margin on U.S. product sales of approximately 80 percent, which is partially offset by gross margin on ex-U.S. product sales to our global partners as per contractual arrangements.

[noise] Amarin continues to maintain strong gross margins with overall gross margin on net product revenue of approximately 78% for the first half of the.

A slight increase compared to the same period in 2019 into driven by gross margin on U.S. product sales of approximately 80%, which was partially offset by the gross margin on X U.S. product sales to our global partners as per contractual arrangements.

Although we've continued to make improvements in our gross margin, let's see if it continues to have a lower gross margin than many other branded drugs do towards a portable pricing and the cost incurred due to the complexity of manufacturing the active pharmaceutical ingredient or EPA at the high quality standards, we have set for vascepa.

Under U.S. GAAP Amarin reported net income of $4.4 million in the second quarter of 2020 or basic and diluted earnings per share of one cents.

Disciplined expense management.

And by temporary suspension of face to face interactions and other selling and marketing initiatives in the second quarter of 2020.

Due to shelter in place and other travel restrictions, resulting from the carbon 19 pandemic.

I think this is particularly noteworthy as we were able to achieve net income despite the limitations to our potential revenue growth, resulting from the reduction in patient visits to their positions and the resulting impact on new prescriptions for the city.

Michael Kalb: Although we've continued to make improvements in our gross margin, Visepa continues to have a lower gross margin than many other branded drugs due to its affordable pricing and the cost incurred due to the complexity of manufacturing the active pharmaceutical ingredient or EPA at the high quality standards we have set for Visepa. Under U.S. GAAP, Amarin reported net income of $4.4 million in the second quarter of 2019, or Basic and Diluted Earnings Per Share of One, with Disciplined Extents Management, and by temporary suspension of face-to-face interactions and other selling and marketing initiatives in the second quarter of 2020. Due to shelter in place and other travel restrictions resulting from the COVID-19 pandemic.

In June we reinstated our U.S. education on promotional programs for the SEPA and as a result in restoring these initiatives and with the continued uncertainty around the impact from Corbett 19, moving forward and is uncertain, whether we will achieve net income in the second half of the year.

Further we anticipate STN a expense to be approximately 10 million to $20 million higher and the second half of 2020 compared to the first half from 2020.

Michael Kalb: I think this is particularly noteworthy as we were able to achieve net income despite the limitations to our potential revenue growth resulting from the reduction in patient visits to their physicians and the resulting impact on new prescriptions for vaccines. In June, we reinstated our U.S. educational and promotional programs for the season. And as a result of restoring these initiatives and with the continued uncertainty around the impact of COVID-19 moving forward, it is uncertain whether we will achieve net income in the second half of the year. Additionally, we anticipate SG&A expense to be approximately $10 million to $20 million higher in the second half of 2020 compared to the first half of 2020. As of June 30th, 2020, Amarin had cash investments in excess of $600 million.

As of June Thirtyth, 2020, Amarin had cash and investments in excess of $600 million accounts receivable net of $125 million, an inventory of $124.8 million.

We continue to maintaining strong balance sheet and believe our current resources are sufficient to fund our projected operations, including our anticipated spend on the direct to consumer campaign previously, but in the United States and successful commercial launch in Europe.

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

Thanks, Mike.

I think our investors for your continued support including your votes in passing all the resolutions put forth in our proxy statement as part of our recent annual shareholders meeting.

I also thank our employees for their dedication professionalism and flexibility.

Michael Kalb: Accounts Receivable Net of $125,000,000 and Inventory of $124,800,000. We continue to maintain a strong balance sheet and believe our current resources are sufficient to fund our projected operations, including our anticipated spend on the direct-to-consumer campaign for Visepa in the United States and successful commercial launch in Europe. With that financial overview, I will now turn the call back to Jon for closing remarks. Jon?

With such a talented group of people I am confident that we will continue to make important progress, particularly if we remain consistent with our core values, including working collaboratively and focusing on improving patient care.

As is hopefully evident from our comments today.

Ameren has some very exciting activities and milestones, which we're looking forward to in the months ahead.

We look forward to sharing our continued progress with you.

With that we conclude our prepared comments and we'd like to open the line for some questions operator.

John Farrell: Thanks, Mike. I thank our investors for your continued support, including your votes in passing all the resolutions put forth in our proxy statement as part of our recent annual shareholders meeting. I also thank our employees for their dedication, professionalism, and flexibility. With such a talented group of people, I am confident that we will continue to make important progress. Particularly if we remain consistent with our core values, including working collaboratively and focusing on improving patient care, as is hopefully evident from our comments today. Amarin has some very exciting activities and milestones which we are looking forward to in the months ahead.

Thank you.

But time will be conducting a question and answer session. If you'd like to ask the question. Please press star one on your telephone keypad, a confirmation tone will indicate your line question Q.

You May press star to if you'd like to remove your question from the Q.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star Keith one moment, please what we pull for questions.

Your first question comes from line up Ami.

Audio we as the be leaving please proceed with your question.

Good morning, Thanks for taking my question I had a some fun ups on your comments and thank you for the detailed comments that was baked yeah.

Operator: We look forward to sharing our continued progress with you. With that, we conclude our prepared comments, and we'd like to open the line for some questions. Operator?

Just with regards to the U.S. patent litigation and the potential risk of generic entry can you talk to the cost of goods that you had admission launch time period. So we get a sense so what.

Operator: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keyboard. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.

Cost of goods could be for generics should they launch.

And a.

Good effect, you might be possible off to the hearing.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Your first question comes from the line of Ami Fadfadia with SVB Lyrinc. Please proceed with your question. Good morning. Thanks for taking my question. I had some follow-ups on your comments, and thank you for the detailed comments. That was very clear.

On September 2nd and then I have a second question on Europe.

Amit Thanks for the questions. Good morning regarding cost of goods sold a yes or no.

But this in the context of gross margin, but remember our goal our net selling prices have been a roughly flat or for a long period of time. So the change that has occurred as a tough her as a result of a and lowering of product costs. So what do we initially launched our gross margins were in the a low fiftys I believe and.

Ami Fadfadia: Just with regard to the U.S. patent litigation and the potential risk of generic entry, can you talk about the cost of goods that you had at the initial launch time period so we get a sense of what the House of Goods could be for generics should they launch and whether a settlement could be possible after the hearing on September 2nd? And then I have a second question on Europe. I mean, thanks for the questions. Good morning.

Took a lot of work to get them into the sixth season than we've been migrating to the seventies to now to the point, where we're a high seventys like last quarter, we we hit Adrian and that is the result of.

A lot of were I am run by our suppliers on a a efficiencies and knowhow and capacity and the scale. So it's not been he has a lot of mistakes a lot of learning along the way, but Ah you know we're proud of what Ben.

John Farrell: Regarding cost of goods sold, you know, I'm going to put this in the context of gross margin, but remember our net selling prices have been roughly flat for a long period of time. So the change that has occurred has occurred as a result of lowering product costs. So when we initially launched, our gross margins were in the low 50s, I believe, and it took a lot of work to get them into the 60s. And then we've been migrating through the 70s to now to the point where we're in the high 70s.

<unk> are there the in terms of settlement.

Yeah the.

They attempted to express to set settle a tricky we'd have to settle both with the.

Two or.

The next month and Dr. reddys the due to litigants, but also you have the court or a decision essentially reversed the court decision or a word to remain in effect.

John Farrell: I think last quarter we hit 80, and that is the result of a lot of work by Amarin and by our suppliers and efficiencies and know-how and capacity and scale. So it's not been easy, a lot of mistakes, a lot of learning along the way, but we're proud of what's been accomplished there. In terms of settlement... You're the... As I attempted to express, settlement is tricky. We'd have to settle both with Hickman and Dr. Reddy, the two litigants, but also have the court decision essentially reversed. If the court decision were to remain in effect such that the patents on the first indication for our product were deemed to be obvious, our settlement with those two players would then allow other players to fill that void and enter the market because there would, in effect, be no patent coverage. So we think our arguments are good.

Such that the patents on the first indication for our product were deemed to be obvious a you know our settlement with those two players to them a lot of other players to fill that void and come in because they wouldn't affect be no no no patent coverage. So we take our arguments are good we're looking forward.

Oral arguments were hoping that the a legal system will appreciate the.

These arguments and do what we think.

It is right, but at this point in time, we're not relying on a settlement and impossible, but we're not relying on or predicting settlement.

Okay great.

It's a box to the decision to launch yeah. So in Europe.

Can you elaborate on kind of how your part about the value creation for shareholder that you can have by going it alone wash the.

John Farrell: We're looking forward to the oral arguments. We're hoping that the legal system will appreciate these arguments do what we think is right, but at this point in time, we're not relying on settlement.

Oh partnering right a in Europe kind of to a large pharma company.

John Farrell: Anything is possible, but we're not relying on or predicting settlement. Okay, great. With regard to the decision to launch yourself in Europe, can you elaborate on kind of how you thought about the value creation for shareholders that you can have by going it alone versus, Partnering Rights in Europe, to a large pharma company, and how do we think about the use of cash? As you continue to market the product in the U.S., at least for the foreseeable future, and ramp up in Europe, can you talk about some of the investments that will Thank you.

And how do we think about the use of costs.

As you continue to market. The product you asked me you know in the foreseeable future and ramp up in Europe can you talk to some of the investments that will be the acquired in Europe over the course, though the next maybe 12 to 18 month.

In terms of the number of you know people on the field sector.

Yeah.

Yeah, so, but thanks for the questions regarding Europe.

Yeah, we started with a review of the opportunity to make sure that we understood.

The enormity in weren't direct their own bathwater on that and and you know all of our analysis that we did a including interaction with doctors, but also use a very consultants in back to confirm to us that they very large market opportunity and we see key opinion leaders over there the urgent.

John Farrell: Yeah, so thanks for the questions regarding Europe. You know, we started with a review of the opportunity to make sure that we understood, you know, the enormity of it and weren't drinking our own bathwater on that. And, you know, all of the analysis that we did, including interaction with doctors, but also the use of various consultants, came back to confirm to us that this is a very large market opportunity. And, you know, we see key opinion leaders over there urging that the drug gets approved and asking us, you know, how this drug is going to be introduced, and very interested in the drug. I think the two leading medical societies jumping on it as quickly as they did last year to add guidelines as an example, but not the only example of that visible need. And then we spent a lot of time, you know, looking at, you know, could we do this?

Drugs get approved and asking US you know how this drug is going to be introduced and very much interested in the drugs I think the two leading medical sided jumping out as quickly as they did last year to add to the guidelines as they example, but not the only example of Oh of that visible need and then we.

Let's spend a lot of time, you're looking at you know could we do this and also what would be available to us or you know from a partnering perspective, and what we think to be a risk adjusted basis or the value creation, you know for our shareholder.

There's on.

I say versus past B and all told we saw a high me so a lot of.

Very experienced people, who could help us with it or we're thrilled to have a great Mattel joining us to lead the commercial effort. That's an example of the high quality people that the.

John Farrell: And also what would be available to us, you know, from a partnering perspective and what we think would be, on a risk-adjusted basis, the value creation for our shareholders on path A versus path B. And all told, we saw a high need. We saw a lot of very experienced people who could help us with it. We're thrilled to have Kareem McHale join us to lead the commercial efforts.

Our available to us and.

You know while working towards the regulatory approval working to make sure we have supply in place we're working to make sure that we have a when I say supply in place. It's all the logistics at the same product, but making sure you get into the Gulf countries. You know, we decided that it was a you know in our best interest to.

To retain the rights to the brought product we think that that provide more value. One did occur for our shareholders were not the sharing you know the economics when somebody over so some of the success here a while we would be funding the cost and I'll get to that moment or we wouldn't be retaining.

John Farrell: I think that's an example of the high-quality people that are available to us. And, you know, while working towards regulatory approval, working to make sure we have supply in place, we're working to make sure that we have, when I say supply in place, it's all the logistics, it's the same product, but making sure it can get into countries. You know, we decided that it was in our best interest to have our own team in place, not just in the United States but in Europe, to provide, you know, greater leverage and value there. Right now, the primary focus is getting the product approved.

All of the profits or you know from that opportunity and you know to the extent that we see other product that we might develop or otherwise would become available to us having their own team in place that not just in the United States, but in Europe of provides greater leverage and value. There you know right now the.

Primary focus is getting a product approved you know we are doing the support tasks like making sure. We have supply logistics, we're doing lots of planning, we're doing lots of interactions with K wells, making sure we're ready for the various reimbursement arguments in advancing reimbursement arguments except the one.

John Farrell: You know, we are doing the support tasks, like making sure we have supply logistics, we're doing lots of planning, we're doing lots of interactions with KOLs, making sure we're ready for the various reimbursement arguments and advancing reimbursement arguments to the extent that one can prior to approval in many countries. In many countries, that can't be advanced until you actually have the label.

Prior to approval and many many countries that can't be advance. So you actually have the.

I have the label.

Initially you know meeting this year you know will you team that we haven't place you remember we are an Irish company, we do have a team in Dublin, that's important to us.

John Farrell: You know, initially, you know, meaning this year, we'll use the team that we have in place. Remember, we are an Irish company, so we do have a team in Dublin that's important to us. You know, we'll develop a team probably this year.

Great well developed games, probably this year Oh, a couple dozen people core team continuing to use consultants in the third parties to no to leverage that and as we get a long further in the reimbursement side of things, which will be on a country by country basis. Some.

John Farrell: Oh, a couple dozen people, the core team, continuing to use consultants and third parties, you know, to leverage that. And as we get along further in the reimbursement side of things, which will be on a country-by-country basis, some undoubtedly faster than others, so that's not unique to us, despite our very strong arguments. We believe that SEPA should have a net price in Europe that's as high, potentially higher than we have in the United States, because we're launching again in Europe for cardiovascular risk reduction, whereas when we launched in the United States, we launched into a genericized market for triglyceride lowering without outcomes data, but we want to make sure we have that reimbursement in place before we really ramp up and add much more significant costs.

I don't think faster than others. So that's that's not unique to us despite our.

Very strong arguments, we believe that the super should have a net price in Europe. The stuff you know as high potentially higher than we have in the United States because we're launching again in Europe for cardiovascular risk reduction, whereas when we launched in the United States, We launched into William.

From a genericized market for triglyceride lowering your without outcomes data.

But we want to make sure we have that reimbursement are in place before we really ramp up and they had much more significant cost well that further comments on our European launch plans or you know in conjunction with the approval of the product.

We do appreciate the proposals that we received that give us a a lot to think about but in the end no. This is about shareholder value and we think that retaining the economics to our fully to ourselves. A you know the this is manageable we are the resource the do it and that a with the right people.

John Farrell: We'll have further comments on our European launch plans in conjunction with the approval of the product. However, we do appreciate the proposals that we received. It did give us a lot to think about. But, in the end, this is about shareholder value, and we think that retaining the economics fully to ourselves is manageable, we have the resources to do it, and that with the right people, we're going to be successful, so it's exciting for us. Okay, thank you so much.

We're going to be successful so it's exciting for us.

Okay. Thanks, so much.

Your next question comes from line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Hi, Thanks for taking my questions here, maybe just to follow but a couple of things. The Ami asked here. So how much of your potential or how many of your potential you partners would have wanted a more global type of collaboration just trying to understand how much the U.S. appeal decision impact at their valuation and thoughts and would you reconsider and you are mark.

Louise Alesandra Chen: Your next question comes from a line from Louise Chen with Cancer Fitzgerald. Please proceed with your question. Hi, thanks for taking my questions here. Maybe just to follow up on a couple of things that Ami asked here.

John Farrell: So how much of your potential or how many of your potential EU partners would have wanted a more global type of collaboration, just trying to understand how much the U.S. appeal decision impacted their valuation and thoughts? And would you reconsider an EU or a more global type of collaboration once there's more clarity on the U.S. appeal? And then the second question is, as it pertains to generic competition, how long did it take for Amarin to expand its gross margins to where they are today and develop the kind of manufacturing efficiencies and value chain that you have? And would generics have to go through that same process, or could they get around that? And the last question is, I know you said that you can't give a lot of color on growth in the second half of the year, but just qualitatively, how should we think about sales progression in the third and fourth quarters? Thank you. Good morning, Louise.

Level type of collaboration once there's more clarity on the U.S. appeal and then second question is as it pertains to generic competition, how long did it take for amarin to expand your gross margins to where they are today and develop the kind of manufacturing efficiencies in value chain that you haven't and well generics have to go to that same process there could they get around that.

And then last question is I know you said that you can't give a lot of color on growth in the second half a year, but just qualitatively how should we think about sales progression that third and fourth quarter. Thank you.

Hi, good morning, ladies lots of questions. There regarding the international process you know our proposals from various companies are confidential and that process and yeah. We've made our decision to move forward with ER going direct in Europe, I think that that is the right Doug decision no there was.

Considerable interest you know, but keep as an important product a it's a growth opportunity and you know we're always out to look to do what's best for our shareholders, but I'm not going to speculate on a on anything that we haven't made decisions on right now we're a very excited about the European.

John Farrell: Lots of questions there. Regarding the international process, you know, our proposals from various companies are confidential in that process. And, you know, we've made our decision to move forward with going direct in Europe. I think that that is the right decision.

Opportunity and we're going to focusing on the execution that's needed to continue to create value through getting the product approved in Europe getting reimbursement in Europe, and and growing it and then you are using that to a springboard potential additional opportunities and the rest of the world. We're obviously also looking forward to the results of the trial in the.

John Farrell: You know, there was considerable interest. Basipa is an important product. It's a growth opportunity. And, you know, we're always out to look to do what's best for our shareholders. But I'm not going to speculate on anything that we haven't made decisions on right now.

China, becoming available later this year and from that you're working with our partner there on what the right or your regulatory strategy is for a China.

With respect to gross margins.

Yeah, we.

When I joined you know Amarin and Oh, Yeah, 11 years ago, you know we were already working with suppliers at that point in time on.

John Farrell: We're very excited about the European opportunity, and we're going to focus on the execution that's needed to continue to create value through getting the product approved in Europe, getting reimbursement in Europe, and growing it, and then, you know, using that to springboard potential additional opportunities in the rest of the world. We're obviously also looking forward to the results of the trial in China becoming available later this year, and from that, you know, working with our partner there on what the right regulatory strategy is for China. With respect to gross margins, you know, we. You know, when I joined Amarin in, you know, 11 years ago, we were already, you know, working with suppliers at that point in time on building, you know, building supply and, You know, it's been over a decade since we got to the stage where we're at, you know.

On a building.

Building supply and you know, it's it's been over a decade, you know to get to that they'd veracity out you know just enough.

That's in the last year, we took steps to increase the.

A lot sizes that were being produced in the type of containers that are being used and and and other prophecy efficiencies. So we're continuing to look for ways to reiterate and improve and diversify because we don't want to be relying on any one supplier. We're fortunate to have very good supplier.

So you know competing with each other on the basis of <unk>.

During the high quality product that our vision cost. So it's certainly didn't happen overnight those early years were.

[noise] somewhat difficult from a.

Supply perspective, a lot the learning along the way and we've got a very good quality organization here very good CMC organization than not able to work a hand to hand with our suppliers to ensure that we we have leveled quality, but you always important this product.

John Farrell: You know, just in the last year, we took steps to increase the lot sizes that were being produced and the type of containers that are being used and, you know, other processes and efficiencies. So we're continuing to look for ways to iterate and improve and diversify because, you know, we don't want to be relying on any one supplier. We're fortunate to have very good suppliers, you know, competing with each other on the basis of ensuring a high-quality product at an efficient cost. So it certainly didn't happen overnight. Those early years were...

Isn't work as well, if it's not major that high quality standard and.

And that that standard isn't just leaving the manufacturing clap, it's been delivery to the.

Due to the patient you know in that stable of form so it's it's it.

Significant area of investment than the an area of know how that you know many good companies you know tried to become supplier for us along the way.

John Farrell: Somewhat difficult from a, Supply Perspective, lots of learning along the way, and we've got a very good quality organization here, a very good CMC organization that's been able to work hand-in-hand with our suppliers to ensure that we have the level of quality that is important. This product just doesn't work as well if it's not made to that high-quality standard. And that standard isn't just leaving the manufacturing plant, it's the delivery to the patient in that stable form. So it's. It's a significant area of investment and an area of know-how that, you know, many good companies, you know, tried to become suppliers for us along the way, and failed. With regard to growth, you know, that's hard to predict in the COVID era, you know, we understand that the need is there, the patients have high need, we understand that there's still very limited awareness that doctors who are learning of the drug, you know, believe in it, prescribe it, you know, we're seeing, you know, increased prescriptions, but if you have patients aren't going to their doctors, and patients aren't going to get lab tests, it's hard to prescribe a new drug to those patients.

And failed.

With regard to grow.

Yeah, that's hard to predict or the Golden era, no. We understand that the need is there the patients have a high need we oh, we understand that there's still very limited awareness doctors, who are learning of the drugs you know, believing that prescribed but now we're seeing increased prescriptions.

Yeah patients aren't going to their doctors and patients aren't going to get lab tests, it's hard to a hard to prescribe a new drugs to a those patients. So you know as we are in the very early stages of getting back out there in terms of.

Her direct your interactions are we're seeing particularly amongst the cardiologist that we're able to start getting into in the.

Late June in early July timeframe, some signs of increased prescriptions, but now this is very early and based upon your very limited a sales calls and you know there can be no assurance that you know those parts of the country, where we're able to quality people don't shut themselves down again, so I think.

The the macro picture is very positive relative to the opportunity for placebo, but being able to predict ER and the shorter term you know how the growth will occur I suspect that will love you'll continue to be somewhat.

John Farrell: So, you know, as we are in the very early stages of getting back out there in terms of Direct Interactions. We're seeing, particularly amongst the cardiologists that we're able to start getting into in late June and early July timeframe, some signs of increased prescriptions, but this is very early and based upon very limited sales calls, and there can be no assurance that those parts of the country where we're able to call on people So I think the macro picture is very positive relative to the opportunity for Fazipa, but being able to predict in the shorter term how the growth will occur, I suspect it will continue to be somewhat volatile, but we've got good people. We believe in the product, and we think we're going to be able to work our way through it. This was a tough quarter for sales.

Volatile, but we've got good people, we believe in the product and we think we're going to be able to work our way through.

Through it you know this was a tough quarter with the sales.

Our sales team you know adjusting to a you know adjusting to all that the phase them I think we're coming out of it the human stronger and we'll continue to look for ways to you'll continue to.

Adapt yeah, I will comment that we had I think good growth under the circumstances, some people probably will get into trying to reconcile scripts with.

With revenues up you know as a reminder in Q1.

Revenues exceeded revenue growth exceeded script growth.

This quarter script growth was a slightly faster than the <unk> revenue growth was on a comparative basis to a two to Q1 those types of things happen.

John Farrell: Our sales team, you know, is adjusting to, you know, adjusting to all that faces them. And I think we're coming out of it, you know, even stronger, and we'll continue to look for ways to, you know, continue to adapt. You know, I will comment that, you know, we had, I think, good growth under the circumstances. Some people probably will get into trying to reconcile scripts with revenues, you know, as a reminder in Q1. Revenue growth exceeded script growth this quarter, although script growth was slightly faster than revenue growth, at least on a comparative basis, to Q1.

That's the nature of estimate provided for like scripts I also remind folks that in Q1, we had some you know some anomalies that we talked about in reporting of that quarter. We had done a effectively an extra week of shipping to wholesalers are revenue recognized based on the shipments to wholesalers in Q1, we had.

Right around 11 million a this oh revenues are resulting from a a that extra week of shipments through your while we also had a yard are a Canadian a partner stocking up for for more than.

Dispose the first quarter was up about $6 million and you know it was a little less than last year and the a into second quarter. They didn't have the Greek restock. So I think all told the you know we had good growth in the burst.

John Farrell: Those types of things happen. That's the nature of estimates provided by scripts. I also remind folks that in Q1, we had some anomalies that we talked about in the reporting of that quarter. We effectively had an extra week of shipping to wholesalers. Our revenues are recognized based on the shipments of wholesalers. In Q1, we had right around $11 million in revenues resulting from that extra week of shipment. We also had our Canadian partner stocking up for launch, which we disclosed in the first quarter was about $6 million and was a little less than that here in the second quarter. They didn't have to restock.

With that drove growth in the first quarter, we're disappointed to the coal bid that we weren't able to grow faster in the second quarter, but if we look up the industry and other drugs that are in the a lit bit space Ah. We certainly are we certainly grew faster than.

Faster than the others and we are encouraged for the future I cant predict how fast will grow.

Thank you.

[noise]. Your next question comes from line of Michael Yee with Jefferies. Please proceed with your question.

Hi, good morning, John.

Thanks, Rob details to share straightforward question.

One on that.

John Farrell: I think all told, we had good growth in the first quarter. We were disappointed through COVID that we weren't able to grow faster in the second quarter. But if we look at the industry and other drugs that are in the lipid space, we certainly grew faster than others.

Glenn patent situation can you just right sized for investors. If you win I think there's no big change goes back to normal if it is an adverse outcome and that thinking in short that they wouldn't be limited players at the outset, if not actually I think when one is approved and that pricing and <unk>.

John Farrell: We are encouraged for the future. I just can't predict how fast we'll grow. Thank you. Your next question comes from the line of Michael Yee with Jeffries. Please proceed with your question. Hey, good morning, John.

Pasadena fairly limited, which I think that's the summary up your opening comments and then the second question is just on Europe in short.

Our comments meant to support a pretty small European infrastructure, I mean, you're talking about Ireland and whatnot show is that the takeaway on Europe that it's a relatively small infrastructure until well into like a 20.1. Thank you.

Michael Yee: Thanks for all the details. Two straightforward questions. One on the ongoing patent situation. Can you just right-size for investors? If you win, I think there's no big change. It goes back to normal.

Hey, Michael Good morning. Thanks for question them and you know just looking at the clock I've, even portfolios to be the last questions that we take today is where people want to get on with era in best investment days.

John Farrell: If it is an adverse outcome, is the thinking in short that there would be limited players at the outset? If not, actually, I think only one is approved, and that pricing and capacity are fairly limited. I think that's the summary of your opening comments. And then the second question is just on Europe in short. Are your comments meant to support a pretty small European infrastructure? I mean, you're talking about Ireland and whatnot.

Well regarding me a the patent side you know clearly we think that the right answer here should be that we win and we then have a exclusivity until generic come into the market and and 2029 think that that is the right answer and event that we were to lose.

So it's our view based upon information available to us that supply for generic companies would be limited flies limited I'm really not a lot of motivation for them to.

Try to get into a pricing war, and particularly because we would not only have a better.

John Farrell: So is that the takeaway on Europe that it's a relatively small infrastructure until well until we get to 2021? Thank you. Hey Michael, good morning.

Better cost efficiencies on the manufacturing side, but we've got limited supply and it's difficult to manufacture.

John Farrell: Thanks for the questions. And just looking at the clock, these unfortunately have to be the last questions that we take today, as people want to get on with their investment days. Regarding the patent side, clearly, we think that the right answer here should be that we win and we then have exclusivity until Generic could come into the market in 2029. I think that that is the right answer.

Why would you sell that limited supply.

Extensively in that scenario.

Which Ah you know provided that there is no limited supply we will evaluate our best Best course, when Ah you know when the information becomes available to us, but we would envision that branded but SEPA would remain a substantial for a you know a substantial period.

Time and will adjust our promotion at that point in time to see whether it should be further increased Ah Ah maintained or you know contracted but I think it's a good.

John Farrell: In the event that we were to lose, you know, it's our view, based upon information available to us, that supply for generic companies would be limited. If supply is limited, there's really not a lot of motivation for them to try to get into a pricing war, particularly because we would undoubtedly have better cost efficiencies on the manufacturing side. But if you've got limited supply, and it's difficult to manufacture, why would you sell that limited supply, you know, inexpensively? In that scenario, which, you know, provided that there is, you know, limited supply, we will evaluate our best course when the information becomes available to us, but we would anticipate that branded VASIPA would remain substantial for, you know, a substantial period of time, and we'll adjust our promotion at that This is not where they can just use their existing facilities and plug this product in and have a generic replacement. So, we would imagine branded.

This is not a typical generic launch this is not where they can good view their existing facilities and plug this product in and have a a generic replacement. So we would envision ranted.

People are being a player for a a substantial period of time with respect to Europe Ah you know the product not yet approved so we will be building a core team and that you know that core team might be this year.

Finally, a couple of doesn't people over and above a the then current infrastructure you know that we have in Europe, and then as we're getting into various countries or you know we would be adding you know sales representation or you know in those countries focusing on the large countries first not going to get it.

Good.

Oh, great details there you know I've been going you know in Europe.

Relative to the United States, a patients who are at higher risk for cardiovascular disease and to not exclusively with tend to be proportionately treated more by specialists, we cardiologists, so whereas in the U.S. you know the GP tend to treat a lot of the.

Yeah that treated patients and they don't necessarily see cardiologists.

John Farrell: The SIPA will be a player for a substantial period of time. With respect to Europe, the product is not yet approved, so we will be building a core team, and that core team might be this year. Roughly a couple of dozen people over and above the current infrastructure that we have in Europe. And then, as we get into various countries, we will be adding more. Sales Representation, you know, in those countries, focusing on the largest countries first; not going to get into, you know, great details there. But I think, you know, in Europe. Relative to the United States, patients who are at higher risk for cardiovascular disease tend to, not exclusively, but tend to be proportionally treated more by specialists, particularly cardiologists, whereas in the U.S., you know, GPs tend to treat a lot of statin-treated patients, and they don't necessarily see cardiologists.

Maybe and works well evaluate this is for a while our ever fine tuning. Our plans are there maybe opportunities for certain elements of efficiency to capitalize in the targeting of physicians in Europe or you know that's a bit different than what we have in the United States, but you know in the United States we.

Started off with Oh, hi, targeting the highest a potential prescribers and then have expanded and continue to expand beyond that a really with the BBC launching here just starting to get beyond the target physicians that we've been going after it was many others, who could potentially prescribers in Europe.

In Europe, no logical course would be to similarly, Oh put together team that's appropriately sized to go after the highest potential ER physicians in terms of education awareness of proceed but in parallel with the reimbursement effort, but you're not get out over our skis, we don't need be putting big teams in place in countries.

John Farrell: So there may be, and we'll evaluate this as we're fine-tuning our plans, opportunities for certain elements of efficiency to be capitalised on in the targeting of physicians in Europe. You know, that's a bit different than what we have in the United States, but, you know, in the United States, we started off with targeting the highest potential prescribers and then have expanded and continue to expand beyond that, really, with the DTC launching here, just starting to get beyond the target physicians that we've been going after to as many others who could be potential prescribers. In Europe, you know, the logic, of course, would be to similarly put together a team that's appropriately sized to go after the highest potential physicians in terms of education and awareness of VASIPA in parallel with the reimbursement efforts, but not to get out over our skis. We don't need to be putting big teams in place in countries, particularly before, you know, reimbursement is established. And reimbursement, you know, will take place on a country-by-country basis. Some are quicker than others. Some allow you to have some access to the market in certain countries before you receive reimbursement, but most don't.

Particularly before you know reimbursement is establishing reimbursement or you will take place on a country by country basis, a summer quicker than others. Some allow you have some access to the market in certain countries.

Before you have reimbursement, but most most most don't so overall, though the spend will be relatively limited until we have both approval and Andrea and reimbursement.

Perfect.

Thanks [noise].

Thank you for those questions. Thanks, everybody knows the long call, we're not really doing traditional investor meetings. These days so as we opportunity would be in front of view is not as frequently as it has been the non kogan era. So no given it was mid year.

But we'd be relatively comprehensive here today hopefully the comments were helpful to you were not a lot going on a lot of milestones coming out as far as we're optimistic that pepper people in the right product executed we look forward for body you updates as we move forward. So.

Thanks again.

John Farrell: So overall, the spend will be relatively limited until we have both approval and reimbursement. Perfect, thanks. Thank you for those questions. Thanks, everybody. I know it's a long call.

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

[noise].

John Farrell: We're not really doing traditional investor meetings these days, so the opportunity to be in front of you is not as frequent as it has been in the non-COVID era. So given it was mid-year, we thought we'd be relatively comprehensive here today. Hopefully, the comments were helpful to you. We've got a lot going on, and a lot of milestones coming up. We're optimistic. We've got the right people and the right product to do it.

Operator: We look forward to providing you with updates as we move forward. So, thanks again. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.