Q2 2022 Amarin Corporation PLC Earnings Call

Operator: Welcome to Amarin Corporation's conference call to discuss its second quarter 2022 financial results and operational updates. This conference call is being recorded today, August 3, 2022.

Welcome to Amarin Corporation's conference call to discuss its second quarter 2022 financial results and operational update. This conference call is being recorded today August three 2022, I would like to turn the call conference call over to Lisa <unk>.

Kareem Mikhail: Thank you and welcome, Dan.

Operator: I would like to turn the conference call over to Lisa DeFrancesco, Senior Vice President, Investor Relations and Corporate Affairs at Amarin.

<unk> Senior Vice President Investor Relations and corporate Affairs.

Operator: Lisa DeFrancesco, Senior Vice President, Investor Relations and Corporate Affairs at Amarin.

Kareem Mikhail: So, you know, we cannot really articulate it in the second quarter as a benefit. In reality, there was a destocking in Q1 and a hit, which was normalized this quarter, right?

Aberdeen.

Lisa DeFrancesco: Good morning, everyone, and thank you for joining us.

Kareem Mikhail: So this is really how it is analyzed.

Good morning, everyone and thank you for joining us.

Kareem Mikhail: It's not like there is, you know, an artificial benefit this quarter. In fact, this is the first quarter where we see prescriptions and bottles really aligned.

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.

Lisa DeFrancesco: 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.

Lisa DeFrancesco: We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place under-reliance on these statements.

We may not achieve our goals carry out our plans or intentions or meet the expectations disclosed in our forward looking statements.

Actual results or events to differ materially. So you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change our forward looking statements do not reflect the potential impact of significant transactions, we may enter into such as mergers acquisitions dispositions joint ventures or any material agreement that we may enter into amend or terminate.

Lisa DeFrancesco: We assume no obligation to update these statements as circumstances change.

Lisa DeFrancesco: Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreement that we may enter into, amend, or terminate.

Lisa DeFrancesco: For additional information concerning the risk 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, 2021, and our Form 10-Q for the quarter ended June 30, 2022, which have been filed with the SEC and are available through the Investor Relations section of our website at www.amarincorp.com.

For additional information concerning risk 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, 2021, and our Form 10-Q for the quarter ended June 32022, which have been filed with the SEC and are available through the Investor Relations section of our web site.

Lisa DeFrancesco: We encourage everyone to read these documents.

At Www Dot Ameren Corp, Dot com, we encourage everyone to read these documents. This call's intended for investors in Amarin and is not intended to promote the use of Vascepa and archive of the call will be posted on <unk> website in the Investor Relations section.

Lisa DeFrancesco: This call is intended for investors in Amarin and is not intended to promote the use of the SIPA.

<unk>, President and Chief Executive Officer will lead our discussion Dr. Steve Ketchum President of R&D and.

Chief Scientific officer will provide an update on recent clinical data and publication and Tom Reilly <unk>, New Chief Financial Officer will provide a more detailed review of our second quarter 2020 financial results. After prepared remarks, we will open the call to your questions.

I remind you that multiple audiences typically listen to calls of this nature, including existing investors potential new investors employees current and potential collaborators and current and potential competitor as always in this call. We will attempt surprised constructive information without compromising our competitive and strategic positioning I will now turn the call over to <unk> President.

Lisa DeFrancesco: An archive of this call will

And Chief Executive Officer of Amarin.

Operator: be posted on Amarin's website in the Investor Relations section.

Kareem Mikhail: So we feel confident that we're balanced where we are today.

Thank you Lisa good morning, and thank you all for joining US today as we enter the second half of this pivotal year for Amazon, We continue to focus on our three dimensional growth strategy.

Or geographic expansion heights, representing diversification in depth or core operation evolution.

Operator: Kareem Mikhail, Amarin's

Recently I surpassed my one year anniversary as president and CEO of Amarin and have had the chance to reflect on the significant transformation of the company over the past year.

Operator: President and Chief Executive Officer, will lead our discussion.

Operator: Dr. Steve Ketchum, President of

In the U S. We face continued pressure from additional generic competition, we focused on maintaining profitability and through our commercial efforts, we were able to retain a level of market share even to this day that is unprecedented in any generic market.

And more importantly continued to deliver a significant positive contribution margin, allowing amarin to self fund the expansion to Europe and internationally.

During this past year, we made the difficult decision to implement two major restructuring.

The first was fully focused on the U S commercial structure and the second impacted our company more broadly in order to manage our costs throughout the period and to address the evolving and challenging U S market dynamics.

We did this while undertaking a bold strategy for global expansion, which was highlighted by more than 10 market access filings in Europe , and multiple regulatory filings in other geographies.

With recent achievements, including three country reimbursement wins in Europe , and a number of international product approvals for Vascepa. We are beginning to see the bold strategy takes shape.

In addition, we completely reshaped our leadership team with over 70% of our executive team joining Cameron in the past year. Many in the last six months.

These accomplishments provide us even greater confidence that our long term objectives for Amazon are ambitious but also achievable.

Operator: R&D and Chief Scientific Officer, will provide an update on recent clinical data and publications,

Now to touch on the second quarter, beginning with comments on Europe , where we have made considerable progress executing our strategy and because it is the source of future growth expansion and value creation for amarin shareholders.

Operator: and Tom Riley, Amarin's new Chief Financial Officer, will provide a more detailed review of our second quarter 2022 financial results.

Lisa DeFrancesco: After prepared remarks, we will open the call to your questions.

Lisa DeFrancesco: I remind you that multiple audiences typically listen to calls of this nature, including existing investors, potential new investors, employees, current and potential collaborators, and current and potential competitors.

2022 has been about laying the foundation for our future across Europe .

Lisa DeFrancesco: As always, in this call, we will attempt to provide constructive information without compromising our competitive and strategic

Midway through the year, we have made considerable progress in key markets with more to come in the second half of 2022.

Lisa DeFrancesco: positioning.

It's important to note that we have taken a regional approach to growth and expansion in Europe , where our success does not rely on any single market, but rather on building strong sustainable diverse revenue streams and individual markets across the country.

Lisa DeFrancesco: I will now turn the call over to Kareem Mikhail, President and Chief Executive Officer of Amarin.

And we were delighted to have achieved final positive reimbursement from nice with reimbursement secured for patients in England and Wales at a strong net price of approximately 176 U S. Dollars. This was a big milestone as it marks our first positive final reimbursement decision for.

I'm, a large EU five market.

Note that net prices in Europe , especially for chronic treatments tend to be much lower than U S prices. This achievement and specifically this level of reimbursed net price acknowledges the value of escape and our ability to demonstrate this value to payers in Europe .

In the UK, we are in the process of establishing formulary access and launch preparations are underway with a formal launch planned for October we were encouraged by the excitement and enthusiasm in the market regarding the final reimbursement decision by the local authorities, including NHS as they look to come.

<unk> cardiovascular health as a key national health priorities.

We're focused on educating the market on the benefits of escape and establishing a escape as a new standard of care to reduce the risk of CV events beyond LDL management.

Our objective is to drive this education through medical and scientific engagement implementing formulary guidelines and building awareness and adoption through multiple commercial channels.

This follows the first national reimbursement decision for basketball in Sweden.

The work to obtain for formulary status and launch is well underway. We also achieved individual patient reimbursement in Denmark are in the process of filing for national reimbursement as a next step in that country.

With these achievements we have truly transition to the next phase of our global expansion strategy.

And I'm pleased to share that we have also made progress in a second major EU five market, Spain, where we have begun pricing discussions with Spain Ministry of health earlier than anticipated. This gives us strong confidence for a possible pricing and reimbursement decision in Spain before year end.

I also want to provide an update on Germany, where we are on the market with temporary reimbursement.

Germany continues to be impacted by unprecedented local market conditions, including health care austerity measures, which are being implemented as a result of the challenging political and economic situation in Europe , which has impacted our sales. During this launch period at this time, we remain in constant dialogue with the German helpful.

Allergies and expect that process to complete in November and we may use our full timeline for these negotiations.

Based on the status of the negotiations and current market conditions, we have suspended our contracted primary care field force to avoid having these resources, becoming permanent which was contractually scheduled to occur we are committed to our presence in Germany pending the outcome of current think wuxi issues with the payer which re.

<unk> actively underway.

This decision reflects our disciplined financial management and is in keeping with how we have been actively managing our investments to remain prudent and flexible across Europe . We continued to advance our reimbursement discussions with national health authorities in Norway, Finland, France, Italy, Israel and the Netherlands.

We have also added to the list, Portugal, Austria, and Switzerland, where we have recently submitted and are now on fire for reimbursement discussions. This brings the total number of submitted dossiers to 14 countries in Europe .

In addition partnership discussions in central and Eastern Europe are advancing well with our reimbursement and pricing success. Thus far we remain on track to receive reimbursement decisions and up to eight countries and to launch first caper in up to six European countries. This year.

Our achievements in Europe in just under one year give us further confidence that the opportunity in Europe remains a 1 billion dollar plus opportunity. We believe 2023 will be unexciting gear, what we expect to pivot to the revenue generation stage of our bold global expansion strategy.

Kareem Mikhail: Thank you, Lisa.

Kareem Mikhail: And the hit that we've seen in the Q1 has been basically normalized where we stand.

Now moving to our adults in the quarter and the U S business in the second quarter of 2022, we recorded $94 $4 million in total net revenue, including $96 million in U S product sales reflecting.

Kareem Mikhail: Good morning, and thank you all for joining us today.

Kareem Mikhail: Moving forward, we hope that we're not going to see any of these disturbances in the trade.

Kareem Mikhail: As we enter the second half of this pivotal year for Amarin, we continue to focus on our three-dimensional growth strategy, breadth, or geographic expansion, height, representing diversification, and depth, or core operational evolution.

Kareem Mikhail: Recently, I surpassed my one-year anniversary as President and CEO of Amarin and have had the chance to reflect on the significant transformation of the company over the past year.

Reflecting the anticipated continued pressure from generic competition in the market.

The results reflect the full impact of the third generic entrant compared with one generic in the market the previous year's quarter.

The pressure was offset by a normalization of some of the trade patterns and inventory Destocking. We saw in the first quarter, which Tom will discuss in greater detail with you shortly.

Kareem Mikhail: In the U.S., we face continued pressure from additional generic competition.

Kareem Mikhail: You can never speculate.

Overall, while the U S market remains challenging I am pleased that the revenue this quarter was consistent relative to the first quarter, which speaks to the efforts of the team to retain and support the business as part of our company wide focus on operational excellence, we remain committed to maintaining a strong contribution margin.

Kareem Mikhail: We focused on maintaining profitability, and through our commercial efforts, we were able to retain a level of market share, even to this day, that is unprecedented in any generic market, and more importantly, continue to deliver significant positive contribution margin, allowing Amarin to self-fund the expansion to Europe and internationally.

Kareem Mikhail: I think the market overreacted to a third generic, and we're not surprised, right?

Kareem Mikhail: Usually in a genetic market, you have all the genetics coming in together on the first month.

Kareem Mikhail: So you rarely see situations where you have six months with one genetic, then another six months with a second genetic, then a third genetic coming in literally after a year and three months.

Kareem Mikhail: So, yes, the wholesalers reacted.

Kareem Mikhail: We understand that.

Kareem Mikhail: But I think now they see that the erosion or the volume progression of the genetics in general is linear, no matter how many, you know, they are on the market.

Kareem Mikhail: And we continue, as a reminder, to retain 60% of, you know, the market despite a year and a half of genetic presence, which I believe, you know, the U.S. team is very proud of.

Our U S business to that end, we took the difficult but necessary step to announced a comprehensive cost reduction plan to address expenses and market dynamics within the U S business, which will result in a $100 million in savings through the middle of next year, Tom will talk more about this plan shortly.

Kareem Mikhail: During this past year, we made the difficult decision to implement two major restructurings. The first was fully focused on the U.S. commercial structure, and the second impacted our company, more broadly, in order to manage our costs throughout the period and to address the evolving and challenging U.S. market dynamics.

Daniel Wool: Got it.

Daniel Wool: Thank you.

Kareem Mikhail: And then focusing on the Europe side, on Germany, can you provide us, with a bit more color on the ongoing discussion with the health authorities there, what the process entails, and what exactly are the possible outcomes that are expected when the process comes to completion in November?

Kareem Mikhail: And then switching to UK, while there might be a slow uptake in 2022, as you have discussed, due to budgeting not being allocated, how should we expect the launch to look like in 2023?

Kareem Mikhail: And what are some of the dynamics at play that would shape the launch trajectory?

The goal of our cost containment initiative is to continue to offset the challenges we are experiencing in the market with a focus on operational excellence that allows us to maintain the U S business positive contribution margin.

Kareem Mikhail: Sure.

Kareem Mikhail: So on Germany, we are now in, I would say the final stages of the negotiation with GKV, with the payer.

Kareem Mikhail: You know, if those negotiations come, we come to an agreement, then that would end maybe in a month or so. And if that doesn't, then there is an additional opportunity for an arbitration that would take you until end of November.

Kareem Mikhail: That's why we decided since things are still, you know, ongoing, and we clearly see based on the market dynamics, the situation in Germany, not for us, but for everybody is incredibly, you know, challenging.

Kareem Mikhail: You know, in terms of healthcare, I mean, there are unprecedented decisions on controlling healthcare budgets, and so on.

Kareem Mikhail: So we thought that the wisest thing is to just save money, right?

Kareem Mikhail: Save money, this is conserve cash, make sure we save this money waiting for a final decision.

While the cost containment initiative in June was comprehensive and involve cost reduction across the entire organization. The largest portion of the savings was related to a reduction in the U S commercial organization, creating a core focus team.

This strategy allows for our core sales force to support branded Vascepa sales by fully targeting around 14, thousands of our most loyal prescribers as we continue to focus on secondary prevention in key CV risk indication such as prior to my in stroke.

Moving forward our efforts are focused on sustaining and supporting the Vascepa brand and prescriber base, we have today in the U S.

Supporting these efforts is the compelling data from reduce it that shows vascepa juice CV events by 35% and prior MDI patients the benefits of Vascepa in these patients who have experienced a heart attack and are at risk for another cardiovascular event at <unk>.

Particularly important given these patients are at an elevated risk for recurrent C. D. Problems. These results further strengthened the case, we are making through the physicians who care for these high risk patients for pure EPA in the form of prescription Iqos open agile as a key intervention beyond status.

Meaningful risk reduction.

Our efforts to secure exclusive business is working so far the exclusive business has not experienced any major changes since the end of last quarter. As a result of these efforts. The exclusive business is continuing to grow as a percentage of the total amarin business.

That said, we expect volumes will continue to experience some pressure throughout this year and as we look ahead to the third quarter. In particular, we anticipate continued pressure from generics as well as lower revenue due to the seasonality typically seen within the third quarter for this market. We will continue to closely monitor the market.

<unk> in the U S and adjust as necessary whatever paulson.

Kareem Mikhail: We did this while undertaking a bold strategy for global expansion, which was highlighted, by more than 10 market access filings in Europe and multiple regulatory filings in other geographies.

Beyond Europe , and the U S. We continue to make progress on our bold plan to unlock the potential of Vascepa internationally.

Kareem Mikhail: With recent achievements, including three country reimbursement wins in Europe and a, number of international product approvals for the SIPA, we are beginning to see the bold strategy take shape.

First let me cover our partner three geographies, our Canadian partner HOS Therapeutics continues to make good progress working with all participating provincial jurisdiction to secure coverage from publicly funded plans across Canada.

They have secured public market access reimbursement for Vascepa in Ontario, Quebec, New Brunswick, Saskatchewan and with other public payers, we look forward to their continued progress in the coming months.

Public markets reimbursement for Vascepa in a large single payer country like Canada is a validation of the CV risk reduction benefits of the product that underscores its firm micro economic value. As a reminder, last year, we agreed to H L. S partnership with Pfizer bite, which H L. S will promote to specialists.

And Pfizer will promote to the large primary care physician groups. We have been closely watching the progress of this strategy as it may be a model that can be replicated elsewhere internationally.

Biologics are partner in the Middle East and North Africa Mena region continues to pursue the review and approval for the cardiovascular risk reduction indication in the kingdom of Saudi Arabia, and Kuwait as a reminder, vascepa is currently approved in a total of six countries in the Mena region, including TASC and <unk>.

Wait for the <unk> indication and in the United Arab Emirates, Lebanon, Bahrain, and Qatar for both the ph D G and cardiovascular risk indication.

Lastly, our partner in China, <unk> received approval for Vascepa in Hong Kong for the CV reduction indication and a commercial launch is being planned for Hong Kong later in the year.

The new drug application for Vascepa in mainland China remains under review by the Chinese National Medical product administration and the NDA includes the previously announced successful results of phase III studies, including grid usage.

According to adding they anticipate that a decision can still be expected by the end of this year.

Kareem Mikhail: Now, if by November, or by end of this month, we see, you know, a positive decision, then we will, you know, very easily rebuild because we have the contacts of our teams, and we can we can reinitiate that.

Now let me cover our expansion efforts beyond these three mentioned geographies.

Kareem Mikhail: But if not, then then we would have in a way, you know, restructured and save the money with very, very minimal cost slash labor law impact.

Kareem Mikhail: So all the scenarios on the table, we can speculate at this point in time.

The plan calls for three waves of regulatory submissions for approval of Vascepa in 20 additional countries in order to ensure that patients in the top 50, cardio metabolic markets worldwide can benefit from Vascepa.

What did that and we continue to make meaningful progress in the first wave of these efforts.

<unk> remain in full assessment by the respective national regulatory authorities in Australia, and New Zealand.

In Israel, and Switzerland dose used are under regulatory review.

And along with Austria are in reimbursement discussions these markets will be managed and discussed within our Europe business.

Moving forward, we remain confident in the multibillion dollar global market opportunity for Vascepa, thus skip out in Europe and internationally.

Pleased with our recent achievements, we are beginning to turn this opportunity into a reality with future launches anticipated later this year and next.

Kareem Mikhail: You know, I have disclosed before that in the UK, which was a very successful negotiation.

Kareem Mikhail: At the end, we went through, you know, a third round of negotiation, which is very, very uncommon in the UK, and it, you know, has given a positive result.

Kareem Mikhail: In addition, we completely reshaped our leadership team, with over 70% of our executive team, joining Amarin in the past year, many in the last six months.

In addition, we took steps to ensure our continued investments in our clinical data and pipeline, including maintaining a strong presence at important medical meetings and implementing a step wise approach to the development of our fixed dose combination, which ensures our ongoing progress with this important pro.

Graham that combines vascepa with the step two.

Kareem Mikhail: These accomplishments provide us an even greater confidence that our long-term objectives for, Amarin are ambitious but also achievable.

Kareem Mikhail: We can't speculate or say that that's going to be the same in Germany.

To talk more about these efforts I will now turn the call over to Dr. Steve Ketchum, Ameren EVP President of R&D, and Chief Scientific officer to discuss recent advancements with our data plans for presentation at this year's European Society of Cardiology annual meeting later, this month and progress with our Fig.

Those combination Steve Thank you Kareem.

Kareem Mikhail: Now to touch on the second quarter, beginning with comments on Europe, where we have made, considerable progress executing our strategy, and because it is the source of future growth, expansion, and value creation for Amarin shareholders.

Kareem Mikhail: But you know, the message is we continue fighting, and we continue negotiating until the last minute we have in the process.

Kareem Mikhail: 2022 has been about laying the foundation for our future across Europe. Midway through the year, we have made considerable progress in key markets, with more to come, in the second half of 2022. It's important to note that we have taken a regional approach to growth and expansion, in Europe, where our success does not rely on any single market, but rather on building strong, sustainable, diverse revenue streams in individual markets across the continent.

Kareem Mikhail: For the UK, we, if you remember, we decided not to invest in any country ahead of reimbursement, to ensure we don't burn cash to prematurely.

Kareem Mikhail: And we were delighted to have achieved final positive reimbursement from NICE, with reimbursement, secured for patients in England and Wales at a strong net price of approximately $176. This was a big milestone, as it marks our first positive final reimbursement decision, from a large EU5 market.

Kareem Mikhail: Now in the UK, we have a final decision.

Today I would like to begin with some remarks in response to the recent media coverage and headlines regarding biomarker analyses of reduce it data as published in circulation.

Kareem Mikhail: Note that net prices in Europe, especially for chronic treatments, tend to be much lower, than US prices. This achievement, and specifically this level of reimbursed net price, acknowledges the, value of VASCEPA and our ability to demonstrate this value to payers in Europe.

Kareem Mikhail: We have a full team on board those you know, you know, that this team is on the field where we are today and working very hard for us to have a strong launch. 2023 is going to be a full year for them.

Kareem Mikhail: In the UK, we are in the process of establishing formulary access, and launch preparations, are underway with a formal launch plan for October.

Kareem Mikhail: We have huge efforts in scientific engagement to build the awareness and the adoption.

Daniel Wool: Thank you very much.

Kareem Mikhail: We believe, you know, the UK launch will be a good proxy of what we can deliver, you know, at a European level, because there is significant adoption.

Kareem Mikhail: We've actually seen tweets by NHS, by the Minister of Health, by others saying they're excited to reimburse the product for their patients in the UK, which is, you know, unheard of.

Kareem Mikhail: So we feel encouraged and we're doing everything possible to drive that moving forward.

Kareem Mikhail: We were encouraged by the excitement and enthusiasm in the market regarding the final, reimbursement decision by the local authorities, including NHS, as they look to combat cardiovascular health as a key national health priority.

Daniel Wool: Thank you.

Kareem Mikhail: We're focused on educating the market on the benefits of VASCEPA and establishing VASCEPA, as a new standard of care to reduce the risk of CV events beyond LDL management.

It is important that investors medical professionals patients our employees and other stakeholders understand that we stand firmly behind the science of our products.

Kareem Mikhail: Our objective is to drive this education through medical and scientific engagement, implementing, formulary guidelines, and building awareness and adoption through multiple commercial channels. This follows the first national reimbursement decision for VASCEPA in Sweden, where the work to obtain formulary status and launch is well underway.

Kareem Mikhail: We also achieved individual patient reimbursement in Denmark, are in the process of filing for national reimbursement as a next step in that country.

Kareem Mikhail: With these achievements, we have truly transitioned to the next phase of our global expansion strategy.

Kareem Mikhail: And I'm pleased to share that we have also made progress in a second major EU5 market, Spain, where we have begun pricing discussions with Spain Ministry of Health earlier than anticipated.

Kareem Mikhail: This gives us strong confidence for a possible pricing and reimbursement decision in Spain before year-end.

Operator: Our final question is coming from Cade Cruz of Goldman Sachs.

Kareem Mikhail: I also want to provide an update on Germany, where we are on the market with temporary reimbursement.

Kareem Mikhail: Germany continues to be impacted by unprecedented local market conditions, including healthcare austerity measures, which are being implemented as a result of the challenging political and economic situation in Europe, which has impacted our sales during this launch period.

Kareem Mikhail: At this time, we remain in constant dialogue with the German health authorities and expect the process to complete in November, and we may use our full timeline for these negotiations.

Kareem Mikhail: Based on the status of the negotiations and current market conditions, we have suspended our contracted primary care field force to avoid having these resources becoming permanent, which was contractually scheduled to occur.

Kareem Mikhail: We are committed to our presence in Germany pending the outcome of current negotiations with the payer, which remain actively underway.

Recently, there has been considerable discussion and debate around exploratory post hoc biomarker analysis published in circulation and what those exploratory data might mean in the overall story behind the science of the reduce it trial.

Kareem Mikhail: This decision reflects our disciplined financial management, and is in keeping with how we have been actively managing our investments to remain prudent and flexible.

Kareem Mikhail: Across Europe, we continue to advance our reimbursement discussions with national health authorities in Norway, Finland, France, Italy, Israel, and the Netherlands.

Kareem Mikhail: We have also added to the list Portugal, Austria, and Switzerland, where we have recently submitted and are now on file for reimbursement discussions.

Kareem Mikhail: This brings the total number of submitted dossiers to 14 countries in Europe.

Additional scientific facts are missing from this discussion and provide a more scientifically based perspective.

First it is important to note that these exploratory biomarker analysis published in circulation were not conducted to provide additional evidence demonstrating effectiveness in reducing cardiovascular risk, but instead to preliminarily explore a subset of potential pathways via which iqos <unk> ethyl.

Might exert some level of effect in this trial.

Second the circulation paper highlights relative percentage increases rather than the absolute increases across the set of Biomarkers studied in this analysis when analyzing these results from an absolute increase perspective they are small.

And they do not correlate to any meaningful changes in outcomes seen in the reduce it trial.

Importantly, all of these biomarkers are exploratory.

And none has been sufficiently validated or correlated with CVD risk and in across clinical trials to enable them to be relied upon to draw meaningful conclusions in other words any speculation on the potential impact of these biomarkers is purely theoretical which has largely been ignored in the discussion to date. In addition.

Kareem Mikhail: In addition, partnership discussions in Central and Eastern Europe are advancing well.

The author submitted a number of additional analysis as part of the iterative manuscript review process, which provide a more balanced perspective on the exploratory biomarker data. However, the journals for viewers and editors selected not to include those analyses in the final published paper.

We believe strongly that had the journal included decent analysis and the accompanying data discussions within the published paper that the conclusions of this sub analysis would be much clearer and this paper, which ended up being more abbreviated than intended.

Would not be leading to the current level of confusion within the cardiovascular community today.

While there can be no guarantee of future acceptance, we will be working with the authors to discuss how best to pursue publication of this data in the future to ensure fair and balanced data in the public domain.

While we welcome scientific exploration and debate. It is important that all of the scientifically based stocks are now considered versus theoretical speculation.

Based on the above points, we continue to stand behind the results of reduce it the definitive large long term outcome study of Iqos vessel with gold standard cardiovascular clinical endpoints.

Our confidence in Vascepa vis Capex comes from the wealth of reduce it data we have generated.

All of which continues to reinforce its CV risk reducing benefits, we continue to support ongoing research and data analysis to reduce it as this work further explores the efficacy and safety profile and additional subgroups of patients and further distinguishes vascepa skipper as one of the most significant products to reduce CV risk.

Since the introduction of status.

We are very pleased to report that additional data on Vascepa Vascepa will be featured at ESC 2022 in Barcelona at the end of this month.

These data will focus on specific patient sub populations at increased risk of a cardiovascular or CV events from the landmark reduce it cardiovascular outcomes trial.

The accepted abstracts include a late breaking science presentation on the significant reduction of S. T elevation, myocardial infarction or stemming with vascepa in the reduce it trial. These and other new findings will be presented by a variety of international academic collaborators based on research or analysis supported by Amarin.

We look forward to the presentation of the supportive data at the meeting.

Turning now to our ongoing development efforts.

The confidence we have from reduce it and other clinical studies has allowed us to invest further in the future of Iqos <unk> ethyl, which is why we are supporting the development of a fixed dose combination portfolio.

On our coastal <unk> ethyl in combination with a statin.

As part of our recent cost savings initiatives, we are taking a more stepwise approach to development in this program, which means that rather than pursue an entire portfolio potential combinations. We have selected one to move into proof of concept manufacturing and testing.

Based on the results of those pharmaceutical development activities across the next several quarters, we will evaluate the next steps for the development program.

The fixed dose combination or FTC product is in the early stages of development.

If successful the combination therapy would be a game changer for patients since it will carry the most significant cardiovascular risk outcome benefit label and would hopefully provide additional market exclusivity.

Kareem Mikhail: With our reimbursement and pricing success thus far, we remain on track to receive reimbursement decisions in up to eight countries and to launch VASCEPA in up to six European countries this year.

Operator: Cade, over to you.

With that overview, let me turn the call back to Korea.

Kareem Mikhail: Our achievements in Europe in just under one year give us further confidence, that the opportunity in Europe remains a $1 billion plus opportunity.

Cade Cruz: Hi.

Kareem Mikhail: We believe 2023 will be an exciting year where we expect a pivot to the revenue generation stage of our bold global expansion strategy.

Thanks, Steve for that detailed overview as I mentioned earlier in addition to revamping our bold strategy across our clinical and commercial organization. We continued to take steps to expand our team globally to better serve amarin strategic focus and objectives. One important appointment was the addition of our new.

<unk> CFO , Tom Reilly Tom.

Tom brings significant financial leadership experience across large global pharma and biotechnology companies as well as a proven track record, leading financial planning and analysis within international and commercial operations. He has already become an integral part of our leadership team and is a great asset as we expand around.

The world with that brief intro, let me turn the call over to Tom to discuss our second quarter 2022 financial performance in further detail Tom.

Kareem Mikhail: Now moving to our results in the quarter and the U.S. business. In the second quarter of 2022, we recorded $94.4 million in total net revenue, including $90.6 million in U.S. product sales, reflecting the anticipated continued pressure from generic competition in the market. The results reflect the full impact of the third generic entrant, compared with one generic in the market the previous year's quarter.

Cade Cruz: Thank you for taking our questions.

Kareem Mikhail: The pressure was offset by a normalization of some of the trade patterns and inventory, destocking we saw in the first quarter, which Tom will discuss in greater detail with you shortly.

Cade Cruz: This is Cade on for Paul.

Thank you Kareem for the introduction.

Everyone.

Cade Cruz: We have two.

I'm pleased to be addressing you today for the first time as Amarin CFO and to report on our financial performance for the second quarter of 2022.

Kareem Mikhail: Overall, while the U.S. market remains challenging, I'm pleased that the revenue this quarter, was consistent relative to the first quarter, which speaks to the efforts of the team to retain and support the business.

Cade Cruz: We wanted to know how you were thinking about planning for potentially recessionary environment, both in the U.S. and the EU in addition to the restructuring, if there's any steps you're going to take.

Let me begin by discussing our results for the quarter.

Kareem Mikhail: As part of our company-wide focus on operational excellence, we remain committed to maintaining, a strong contribution margin for our U.S. business. To that end, we took the difficult but necessary step to announce a comprehensive cost reduction, plan to address expenses and market dynamics within the U.S. business, which will result in $100 million in savings through the middle of next year.

Cade Cruz: And then number two was how do you think about the margins for the U.S. business going forward, post-restructuring?

For the second quarter of 2022, we reported total net revenue of $94 4 million, including net product revenue of $93 8 million.

Cade Cruz: Thank you so much.

A decrease of 39% compared to the second quarter of 2021.

Kareem Mikhail: Thank you.

U S product revenue was $90 6 million a decline of $2 9 million versus the first quarter of 2022.

The results represent continued generic pressure in the U S, including the first full quarter with the three generics on the market.

As a reminder, go into three months ended June 32021, there was only one generic in the market.

During the second quarter, we saw a normalization in the trade channel.

When compared to the prior quarter with continued to experience pressure on both volume and price.

We've continued our focus on retaining exclusive business and that business has remained stable.

Going forward, we are not investing to grow the molecule in the U S market, but we are investing in sustaining and supporting the Vascepa brand and prescriber base, we have today in the U S.

We expect volumes and price will continue to experience pressure throughout the throughout this year.

And also anticipate the seasonality typically seen within the third quarter for the market. The results also included international product revenue of $3 1 million, including $2 3 million and commercial supply shipments to HOS in Canada as it began receiving reimbursements in the individual provinces and <unk>.

$7 million and European product revenue.

Cost of goods sold for the three months ended June 32022 was $50 8 million compared to $32 $2 million in the corresponding period of 2021.

During the three months ended June 32022, Ameren has taken steps to amend supplier agreements to align supply arrangements with current and future market demand.

<unk> in a charge of $15 million.

Also ameren recorded a charge of $9 6 million related to unhelpful inventory, which is not related to product data.

Excluding the impact of these two items gross margin was 72% for the three months ended June 32022.

The product has a long lead time in terms of manufacturing and the market and demand for Vascepa has been difficult to predict.

Related to the volatility of the U S generic market.

Significant steps were taken to re negotiate future price commitments of inventory in Q2. The renegotiation of these agreement as it is a very important step forward in lowering future cash burn related to building new inventory efforts are ongoing and inventory purchases are expected to be significantly.

In the second half of 2022.

Moving to operating expenses.

During the second quarter of 2022, we reported expenses of $106 5 million.

Which includes a $10 2 million restructuring expense. This is a decrease of six 6% compared to the second quarter of 2021. The decrease is primarily related to the implementation timing of the initial cost savings that we announced in October of 2021. These savings were partially offset by our investments in growth.

Expansion in Europe , and other markets outside of the U S.

As Corey mentioned earlier in June we announced in.

An additional comprehensive cost savings plan that will result in a $100 million in savings to the middle of next year.

Cost reduction plan, including included savings related to the U S workforce reduction, which reduced the total company employee base by over 40% from current levels. The plan also included streamlined operational expenditures, including reductions Reallocations and overall selling general and.

<unk> expenses.

As well as savings related to refining the company R&D strategy to a more focused stepwise approach towards FTC program.

As a result of these cost savings efforts the company incurred $10 2 million in restructuring charges in the second quarter.

We will begin to see the benefit of the cost reduction in the third quarter of 2022.

And we will be focused on maintaining our operational efficiencies going forward. The U S business continues to be profitable from a contribution margin perspective and.

And provides support for the expansion into Europe , and other geographies around the world.

Under U S. GAAP Amarin reported net loss of $70 million for the second quarter 2022, our basic and diluted loss per share of <unk> 18.

As of June 32020 to Amarin reported aggregate cash and investments of $324 6 million.

We have taken significant steps this quarter to reduce our cash burn moving forward.

We plan to continue to manage our cash prudently relative to business performance and believe our current available cash and resources, including U S profitability are adequate to support continued operations, including European launch activities for at least the next 12 months.

Kareem Mikhail: Tom will talk more about this plan shortly.

Now I will turn the call back to cream for closing remarks, great. Thank.

Kareem Mikhail: The goal of our cost containment initiative is to continue to offset the challenges we, are experiencing in the market with a focus on operational excellence that allows us to maintain the U.S. business' positive contribution margin. While the cost containment initiative in June was comprehensive and involved cost reduction, across the entire organization, the largest portion of the savings was related to a reduction in the U.S. commercial organization, creating a core focus team.

Kareem Mikhail: The strategy allows for a core sales force to support branded Visepa sales by fully targeting, around 14,000 of our most loyal prescribers as we continue to focus on secondary prevention in key CV risk indication, such as prior MI and stroke.

Thank you Tom for that financial overview, we have made a great deal of progress. Despite this year's challenges for both amarin and for the industry.

Kareem Mikhail: Going forward, our efforts are focused on sustaining and supporting the Visepa brand, and prescriber base we have today in the U.S. Supporting these efforts is the compelling data from ReduceIT that shows Visepa reduced, CV events by 35% in prior MI patients. The benefits of Visepa in these patients who have experienced a heart attack and are at, risk for another cardiovascular event are particularly important given these patients are at an elevated risk for recurrent CV problems.

Kareem Mikhail: These results further strengthen the case we are making to the physicians who care for, these high-risk patients for pure EPA in the form of prescription icosapent ethyl as a key intervention beyond statins for meaningful risk reduction.

Kareem Mikhail: So, you know, I think the environment is very challenging now overall.

Kareem Mikhail: Our efforts to secure exclusive business is working so far. The exclusive business has not experienced any major changes since the end of last quarter, as a result of these efforts. The exclusive business is continuing to grow as a percentage of the total Ameren business.

This progress provide us with a renewed sense of energy and focus on our bold vision to stop cardiovascular disease from being a leading cause of death worldwide.

Kareem Mikhail: That said, we expect volumes will continue to experience some pressure throughout this, year and as we look ahead to the third quarter in particular, we anticipate continued pressure from generics as well as lower revenue due to the seasonality typically seen within the third quarter for this market.

Kareem Mikhail: It was tough for us as a company for the last year in any case.

Our continued ability to adapt and evolve with changing dynamics over the last 12 months as well as the recent important and significant reimbursement achievements in Europe provide me with even more confidence in our objective to build a multibillion dollar global franchise and ensure patients globally can benefit from vasu.

Kareem Mikhail: We will continue to closely monitor the market dynamics in the U.S. and adjust as necessary, wherever possible.

Kareem Mikhail: And again, as a reminder, we did implement two restructuring already.

Kareem Mikhail: Beyond Europe and the U.S., we continue to make progress on our bold plan to unlock the, potential of Visepa internationally.

Kareem Mikhail: First, let me cover our partner three geographies.

Kareem Mikhail: So we had one in October of 2021.

Kareem Mikhail: Our Canadian partner, HLS Therapeutics, continues to make good progress working with all participating, provincial jurisdictions to secure coverage from publicly funded drug plans across Canada. They have secured public market access reimbursement for Vesipa in Ontario, Quebec, New Brunswick, Saskatchewan, and with other public payers.

Kareem Mikhail: We look forward to their continued progress in the coming months.

Kareem Mikhail: Public market reimbursement for Vesipa in a large single payer country like Canada is, a validation of the CV risk reduction benefits of the product that underscores its pharmacoeconomic value.

Kareem Mikhail: As a reminder, last year we agreed to HLS partnership with Pfizer by which HLS will, promote to specialists and Pfizer will promote to the large primary care physician groups. We have been closely watching the progress of this strategy as it may be a model that, can be replicated elsewhere internationally.

Kareem Mikhail: Biologics, our partner in the Middle East and North Africa, MENA region, continues to, pursue the review and approval for the cardiovascular risk reduction indication in the Kingdom of, Saudi Arabia and Kuwait.

Kareem Mikhail: As a reminder, Vesipa is currently approved in a total of six countries in the MENA region, including KSA and Kuwait for the VHTG indication, and in the United Arab Emirates, Lebanon, Bahrain, and Qatar for both the VHTG and cardiovascular risk indications. Lastly, our partner in China, Eding, received approval for Vesipa in Hong Kong for the CV, reduction indication and a commercial launch is being planned for Hong Kong later in the year.

Kareem Mikhail: Then we had the second one in June of 2022.

And with that operator, we are ready to take questions.

Kareem Mikhail: So we've been very proactive so far to be on top of our cost structure.

Thank you very much ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone handset at this time. We also painting a question you. Please pickup your handset if you stay on a speaker phone to provide optimum sound quantity. Please hold while we.

Kareem Mikhail: And I can tell you we're going quarter by quarter looking at our contribution margin, because that's for us the most important KPI we look at.

Kareem Mikhail: The key actions we've taken, we're proactive to ensure we will be able to deliver future, contribution margin that is needed for us to self-fund.

Kareem Mikhail: The new drug application for Vesipa in mainland China remains under review by the Chinese, National Medical Product Administration, and the NDA includes the previously announced successful results of phase three studies, including reducing.

Kareem Mikhail: At the same time, we keep our finger on the pulse.

Kareem Mikhail: According to Eding, they anticipate that a decision can still be expected by the end, of this year.

Kareem Mikhail: If we see that the market conditions, you've seen us taking action in Germany, right?

Kareem Mikhail: Now let me cover our expansion efforts beyond these three mentioned geographies. The plan calls for three waves of regulatory submissions for approval of Vesipa in 20, additional countries in order to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from Vesipa. Toward that end, we continue to make meaningful progress in the first wave of these efforts. Dossiers remain in full assessment by the respective national regulatory authorities, in Australia and New Zealand. In Israel and Switzerland, dossiers are under regulatory review and along with Austria are, in reimbursement discussions.

Kareem Mikhail: We are ready to take further actions if need be.

Kareem Mikhail: For the moment, we don't see that happening because I believe we've done a pretty, significant effort in the last restructuring with almost 40% of, you know, headcount impacted in the company, right, ahead of all those headwinds.

Poll for questions.

Kareem Mikhail: These markets will be managed and discussed within our Europe business.

Thank you. Your first question is coming from Michael Yee of Jefferies. Michael Please ask your question.

Kareem Mikhail: Moving forward, we remain confident in the multi-billion dollar global market opportunity, for Vesipa in Europe and internationally and are pleased with our recent achievements.

Kareem Mikhail: But you never know how the market is going to shape.

Kareem Mikhail: We are beginning to turn this opportunity into a reality with future launches anticipated, later this year and next. In addition, we took steps to ensure our continued investments in our clinical data and pipeline, including maintaining a strong presence at important medical meetings and implementing a stepwise approach to the development of our fixed dose combination, which ensures our ongoing progress with this important program that combines Vesipa with Estafi.

Kareem Mikhail: So we continue to be vigilant and we will react if need be.

Hi, Good morning. This is starting to weigh on the line for Michael Thanks.

Kareem Mikhail: The last question was on...

Thanks for taking my question I guess a couple for me first can you comment on the U S sales trajectory going forward and how you expect <unk> sales to pick up.

Kareem Mikhail: To talk more about these efforts, I will now turn the call over to Dr. Steve Ketchum, AMRIN EVP, President of R&D and Chief Scientific Officer, to discuss recent advancements with, our data, plans for presentation at this year's European Society of Cardiology Annual Meeting later this month, and progress with our fixed-dose combination.

<unk> that youre getting reimbursement decisions right now in that region for 2022, So maybe comment on how we should think about 2023.

Secondly, I might have missed that part, but could you elaborate on the supplier agreement.

<unk>.

And the Unsalable inventory and also do you expect this to happen again in the future and maybe lastly.

I appreciate that you're focused on look about fixed.

<unk> fixed dose combination but in parallel.

Could you comment on your pediatrics as well if I recall that you have plans to drop.

In light of some assets in the metabolic area. Thank you.

Kareem Mikhail: Margin?

Well thank you.

What we will try to take them one by one let's just start with the U S trajectory first of all we're pleased that this quarter. We've seen you know.

Kareem Mikhail: Steve.

Kareem Mikhail: Yeah, on margins.

Our revenues to be in line with what we had in Q1.

Steve Ketchum: Thank you, Kareem.

Kareem Mikhail: In the US, I mean, look, I mean, we've had a one-time impact on our margins this quarter.

Kareem Mikhail: We don't see this being repeated.

If you really analyze this performance you'll see that from a volume perspective, we are declining and the 7%, 8% prescription versus the Q1 of 2022 which is what is expected. So this is really in line with expectation at the same time, we also continue to.

Steve Ketchum: Today I would like to begin with some remarks in response to the recent, media coverage and headlines regarding biomarker analyses of reduced data as published in circulation.

Kareem Mikhail: We'll have to see how things evolve, but if there are any additional one-time effects, it is possible, but we don't see that as a trend.

Steve Ketchum: It is important that investors, medical professionals, patients, our employees, and other stakeholders, understand that we stand firmly behind the science of our product. Recently, there has been considerable discussion and debate around exploratory post-hoc biomarker analyses published in circulation and what those exploratory data might mean in the overall story behind the science of the REDUCE-IT trial.

Steve Ketchum: Additional scientific facts are missing from this discussion and provide a more scientifically-based perspective.

Steve Ketchum: First, it is important to note that these exploratory biomarker analyses published in circulation were not conducted to provide additional evidence demonstrating effectiveness in reducing cardiovascular risk, but instead to preliminarily explore a subset of potential pathways via which icosapent ethyl might exert some level of effect in this trial.

You have a price impact because we are losing volume in the nonexclusive segment, where we have lower rebates, but this is more or less getting towards stabilization because now most of our business is really coming from the exclusive business.

Steve Ketchum: Second, the circulation paper highlights relative percentage increases rather than the absolute increases across the set of biomarkers studied in this analysis.

Steve Ketchum: When analyzing these results from an absolute increase perspective, they are small and they do not correlate to any meaningful changes in outcomes seen in the REDUCE-IT trial.

Steve Ketchum: Importantly, all of these biomarkers are exploratory and none has been, sufficiently validated or correlated with CBD risk in and across clinical trials to enable them to be relied upon to draw meaningful conclusions.

Steve Ketchum: In other words, any speculation on the potential impact of these biomarkers is purely theoretical, which has largely been ignored in the discussion to date.

Steve Ketchum: In addition, the authors submitted a number of additional analyses as part of the iterative manuscript review process, which provide a more balanced perspective on the exploratory biomarker data. However, the journal's reviewers and editors elected not to include those analyses in the final published paper.

Steve Ketchum: While there can be no guarantee of future acceptance, we will be working with the authors to discuss how best to pursue publication of this data in the future to ensure fair and balanced data in the public domain.

Steve Ketchum: We believe strongly that had the journal included these analyses and the accompanying dated discussions within the published paper, that the conclusions of this sub-analysis would be much clearer and this paper, which ended up being more abbreviated than intended, would not be leading to the current level of confusion within the cardiovascular community today.

Steve Ketchum: While we welcome scientific exploration and debate, it is important that all of the scientifically based facts are known and considered versus theoretical speculation.

Steve Ketchum: Based on the above points, we continue to stand behind the results of REDUCE-IT, the definitive, large, long-term outcome study of icosafent ethyl with gold standard cardiovascular clinical. Endpoints.

Steve Ketchum: Our confidence in Vasipa Vaskepa comes from the wealth of Reducit data we have generated, all of which continues to reinforce its CV risk reducing benefits.

Steve Ketchum: We continue to support ongoing research and data analysis of Reducit as this work further explores the efficacy and safety profile in additional subgroups of patients and further distinguishes Vasipa Vaskepa as one of the most significant products to reduce CV risks since the introduction of statins.

Steve Ketchum: We are very pleased to report that additional data on Vasipa Vaskepa will be featured at ESC 2022 in Barcelona at the end of this month.

Steve Ketchum: These data will focus on specific patient subpopulations at increased risk of a cardiovascular or CV event from the landmark Reducit cardiovascular outcomes trial.

Steve Ketchum: The accepted abstracts include a late-breaking science presentation on the significant reduction, of ST elevation myocardial infarction or STEMI with Vasipa in the Reducit trial. These and other new findings will be presented by a variety of international academic collaborators based on researcher analyses supported by Amarin.

So over time, yes.

Steve Ketchum: We look forward to the presentation of these supportive data at the meeting.

Dissipate, obviously at Q3 decline because it's seasonal and because we have a volume, but we see the price erosion overtime over the next two to three quarter stabilizing in a certain way. So we're pleased with this quarter. We continue to monitor the situation very closely and we'll see how things are going to evolve into.

<unk>.

Europe , we're going to try to address like two or three questions in one.

Furthermore, in 2022 is the year for reimbursement in Europe , that's not our revenue generation here. The focus today is to get as many countries, but more importantly at the right price and you've seen.

The team delivering very strongly on that promise with a final net price in the U K of around $176 is significantly higher than our net price in the U S. Even prior to any price erosion right totally in line with what we committed to at <unk>.

The beginning of our European journey, the UK is known to be a challenging market from a pricing reimbursement perspective. So the fact that they came out and they came out as our second country gives us confidence that that's really that's the trend that that's what we're going to be delivering over time. It takes.

It's more time, obviously to get to that level of net price, but we are engaged with all of the payers and negotiations continue 2023 is going to be the revenue generation year. This is the year, where we're going to have.

Fixed market launching by year end 2022 so the remaining will launch in 2023. So this is when we switch from pricing reimbursement to true revenue generation in probably.

Markets at that at that point in time.

On questions regarding <unk>.

Supplier.

Contract amendments I'll start, but also let let Tom.

Tom Riley: Tom, you want to add anything?

Share more detail.

Had a choice between after we've seen the Q1 results and the significant shift in the U S business.

Either to take a year to 18 months to adjust inventory level. Because this is a very long lead manufacturing process.

And if we took down that trout, we would burn a lot of cash by the time, we fix it so we decided to renegotiate with our suppliers. So that we can find arrangements so Tom.

Tom Riley: Yeah, I would just say with that, we were contribution margin positive again in the, quarter and we continue to do so in order to invest into the European and the rest of the world market.

Tom Riley: Yeah, great.

Yes, Craig just to follow up so it's multiple.

We have multiple arrangements long lead time on the product we see this as a good first step to stabilizing our working capital related to inventory.

Tom Riley: Thanks.

Tom Riley: Thanks, Tom.

And we'll continue to work with our suppliers moving forward to make sure that we stabilized the supply purchases to reflect existing demand.

Tom Riley: Awesome.

Operator: Any further questions?

And I think the second question was related to.

The inventory charge of approximately 10 million, which we which we had.

Operator: Okay.

Operator: Okay, we don't have any further questions in the queue.

<unk> this quarter.

Give a little background. This charge was a result of it.

Inventory that was damaged by one of our third party suppliers.

Cause the inventory not to be up to our quality standards.

So we have worked we have worked diligently with our supplier to ensure that the proper procedures are in place to mitigate this in the future.

Kareem Mikhail: I'll now hand back over to Karim if he has any final comments.

So that situation.

Kareem Mikhail: Well, I just wanted to thank everyone for the call today.

Thank you Tom.

Steve Ketchum: Turning now to our ongoing development efforts, the confidence we have from Reducit and other clinical studies has allowed us to invest further in the future of icosapent ethyl, which is why we are supporting the development of a fixed dose combination portfolio centered on icosapent ethyl in combination with a statin.

Kareem Mikhail: We believe we've had, you know, a strong quarter with significant success in the UK, in Sweden.

The fixed dose combination we continue as you've seen despite the fact that we streamlined the investments in terms of development to ensure that we keep the project active and ongoing because we believe there is significant opportunity of having a fixed dose combination on the market, but we decided to focus.

Only on one stat that we made progress we are indeed.

Steve Ketchum: As part of our recent cost savings initiatives, we are taking a more stepwise approach to development in this program which means that rather than pursue an entire portfolio of potential combinations, we have selected one to move into proof of concept manufacturing and testing. Based on the results of those pharmaceutical development activities across the next several quarters, we will evaluate the next steps for the development program. The fixed dose combination or FDC product is in the early stages of development.

Steve Ketchum: If successful, the combination therapy would be a game changer for patients since it will carry the most significant cardiovascular risk outcome benefit label and would hopefully provide additional market exclusivity.

In the phase of.

Prototype manufacturing and getting ready.

Steve Ketchum: With that overview, let me turn

Four four for next steps.

And our BD position remains as such we continue looking for assets that will provide.

U S revenue in the U S.

Kareem Mikhail: Our US performance is on track and is delivering the contribution margin that we expect.

Kareem Mikhail: So we continue to move forward and we look forward to share more progress and updates, with you in the next quarter.

For us and for the Great team, we have in the U S to focus on on top of on top of Vascepa.

But we're also open to other opportunities. So we'll see how that is going to evolve over time, but thank you for the question.

Kareem Mikhail: Thank you all for being on the call.

Thank you very helpful. Thank you.

Kareem Mikhail: Thank you.

Yes.

Thank you so much. The next question is coming from Louise Chen of Cantor Luis Please ask your question.

Kareem Mikhail: the call back to Kareem.

Operator: Thank you ladies and gentlemen, this does conclude today's conference call.

Hi, good morning, congratulations on all the progress this quarter and thanks for taking my questions. So I wanted to ask you about your SG&A in the third and fourth quarter given your cost reduction program, how should we think about it relative to the second quarter. If you can't give exact numbers.

Kareem Mikhail: Thanks, Steve, for that detailed overview.

Operator: You may disconnect your phone lines at this time and have a wonderful day.

Operator: Thank you for your participation.

And then secondly, just on the sale of the nuance in that there aren't in fourth quarter, but that just I guess during the first half of year. We got a lot of questions on how to think about sales and is there going to be up or down quarter over quarter. So any color you could give or any thoughts on the cadence or nuances would be very helpful.

Kareem Mikhail: As I mentioned earlier, in addition to revamping our bold strategy across our clinical and commercial organization, we continue to take steps to expand our team globally to better serve Amarin's strategic focus and objectives. One important appointment was the addition of our new CFO, Tom Riley. Tom brings significant financial leadership experience across large global pharma and, biotechnology companies as well as a proven track record leading financial planning and analysis within international and commercial operations. He has already become an integral part of our leadership team and is a great asset as we expand around the world.

Question I had was just Tom as the new CFO , what do you want to bring to Amarin and how will you do things differently at the organization going forward. Thank you.

Kareem Mikhail: With that brief intro,

Kareem Mikhail: let me turn the call over to Tom to discuss our second quarter 2022 financial performance in further detail.

Thank you Louise.

So we can start with the SG&A and then basically from that I can give it the thought to continue so.

If you remember we implemented our restructuring really in June so most of the benefits in terms of.

Cost reductions are really going to start to be seeing from Q3 Q4.

And the first half of next year and our display may be in the range of $50 million. This year $50 million next year.

But that's really at a high level, Tom you want to add to that.

Tom Riley: Tom?

Related to the savings yes.

So we named <unk>.

As we mentioned earlier, none of the results our savings for.

Reflected in the Q2 results. So we expect overall that we'll have over $100 million of savings related to these cost reductions over the next 12 months.

They will be spread over over the next 12 months.

Okay.

And then Luis had to get a question related to the.

Tom Riley: Thank you, Kareem, for the introduction.

Maybe in the new CFO .

Overall very excited to be at Amarin.

Tom Riley: Good morning, everyone.

Like every other CFO looking for to drive the function.

To be best in class. So that's number one focus are a focus I think overall, what we see is to stabilize the U S continued contribution margin in the U S.

So that we can support overall, the European investments and really grow the company through our European and International base that gets me very excited and glad to join amarin to deliver on that.

Tom Riley: I'm pleased to be addressing you today for the first time as Amarin's CFO and to report on our, financial performance for the second quarter of 2022.

Thank you Tom just to go back because I think there was also a question on the cadence on the U S revenue on what to expect over the next quarter.

Tom Riley: Let me begin by discussing our results for the quarter.

Tom Riley: For the second quarter of 2022, we reported total net revenue of $94.4 million, including, net product revenue of $93.8 million, a decrease of 39% compared to the second quarter of 2021. U.S. product revenue was $90.6 million, a decline of $2.9 million versus the first quarter, of 2022. The results represent continued generic pressure in the U.S., including the first full quarter, with three generics on the market.

Tom Riley: As a reminder, during the three months ended June 30, 2021, there was only one generic, in the market. During the second quarter, we saw a normalization in the trade channel. When compared to the prior quarter, we continued to experience pressure on both volume and, price.

Tom Riley: We have continued our focus on retaining exclusive business, and that business has remained stable.

So as we said we have seen within the exclusive segment, which is now the large majority of our business establish Asian and volume if not.

Tom Riley: Moving forward, we are not investing to grow the molecule in the U.S. market, but we are, investing in sustaining and supporting the Visepa brand and prescriber base we have today in the U.S. We expect volumes and price will continue to experience pressure throughout this year, and also anticipate the seasonality typically seen within the third quarter for the market.

Tom Riley: The results also included international product revenue of $3.1 million, including $2.3 million, in commercial supply shipments to HLS and Canada as they began receiving reimbursements in their individual provinces, and $0.7 million in European product revenue.

Tom Riley: Cost of goods sold for the three months ended June 30, 2022, was $50.8 million compared, to $32.2 million in the corresponding period of 2021. During the three months ended June 30, 2022, Amren has taken steps to amend supplier agreements, to align supply arrangements with current and future market demand, resulting in a charge of $15 million.

Tom Riley: Also Amren recorded a charge of $9.6 million related to unsellable inventory, which is, not related to product dating.

Tom Riley: Excluding the impact of these two items, gross margin was 72% for the three months ended, June 30, 2022. The product has a long lead time in terms of manufacturing, and the market and demand, for Visepa has been difficult to predict related to the volatility of the U.S. generic market. Significant steps were taken to renegotiate future price commitments of inventory in Q2. The renegotiation of these agreements is a very important step forward in lowering future, cash burn related to building new inventory.

Sort of single digit.

Growth in volume so so we can.

Tom Riley: Efforts are ongoing, and inventory purchases are expected to be significantly lower in, the second half of 2022.

Fairly confident that we are keeping track on on that one we continue to see price erosion and the nonexclusive, we continue to lose volume obviously, there, but if this in fact is slowing overtime. Obviously Q3, there is a seasonality so.

Tom Riley: Moving to operating expenses. During the second quarter of 2022, we reported expenses of $106.5 million, which includes, a $10.2 million restructuring expense. This is a decrease of 6% compared to the second quarter of 2021. The decrease is primarily related to the implementation timing of the initial cost savings that were, announced in October of 2021.

Tom Riley: These savings were partially offset by our investments in growth and expansion in Europe, As Karim mentioned earlier, in June we announced an additional comprehensive cost savings plan that will result in $100 million in savings through the middle of next year.

Tom Riley: The cost reduction plan included savings related to U.S. workforce reduction, which reduced, the total company employee base by over 40% from current levels.

Tom Riley: The plan also included streamlined operational expenditures, including reductions, reallocations, and overall selling, general and administrative expenses, as well as savings related to refining the company R&D strategy to a more focused, stepwise approach for its FDC program. As a result of these cost savings efforts, the company incurred $10.2 million in restructuring, charges in the second quarter.

Tom Riley: We will begin to see the benefit of the cost reduction in the third quarter of 2022, and, we will be focused on maintaining our operational efficiencies going forward.

Overall, we continue to focus on contribution margin. This is the number one driver of our efforts in the U S. The U S is delivering a very significant contribution margin that is supporting the organization drive European business and our investments in the regulatory approvals globally.

Tom Riley: The U.S. business continues to be profitable from a contribution margin perspective and, provide support for the expansion into Europe and other geographies around the world.

Tom Riley: Under U.S. GAAP, Amarin reported net loss of $70 million for the second quarter, 2022, for basic and diluted loss per share of $0.18. As of June 30, 2022, Amarin reported aggregate cash and investments of $324.6 million.

Tom Riley: We have taken significant steps this quarter to reduce our cash burn moving forward. We plan to continue to manage our cash prudently relative to business performance and believe, our current available cash and resources, including U.S. profitability, are adequate to support continued operations, including European launch activities, for at least the next 12 months.

Furthermore, meant from a contribution margin we continue to deliver on target and we'll keep we'll keep the effort.

Kareem Mikhail: Now I will turn the call back to Kareem for closing remarks.

Thank you Luis.

Thank you.

Kareem Mikhail: Kareem?

Your next question is coming from Rwanda release of SB SBB Securities. Please ask your question.

Kareem Mikhail: Thank you, Tom, for that financial overview.

Great. Thanks, Good morning, everyone. So maybe focusing on the Europe front two questions from me I noticed you mentioned suspending the primary care sales force in Germany, and curious how might that impact or benefit your overall spend and how long do you plan to keep the suspension in place and also whats focus.

Kareem Mikhail: We have made a great deal of progress despite this year's challenges for both Amarin and, for the industry.

Kareem Mikhail: This progress provides us with a renewed sense of energy and focus on our bold vision to, stop cardiovascular disease from being a leading cause of death worldwide.

Kareem Mikhail: Our continued ability to adapt and evolve with changing dynamics over the last 12 months, as well as the recent important and significant reimbursement achievements in Europe, provide me with even more confidence in our objective to build a multi-billion dollar global franchise and ensure patients globally can benefit from the SIPA, the SCEPA.

Question on Sweden, and the UK as newer countries coming online I was curious what additional investments do plan, there and how do you see the outlook.

Operator: And with that, operator, we are ready to take questions.

For those countries as well.

Sure. So so in Germany, we chose very early on because we came very very early to the German market.

They basically have a contractual agreement with a third party to have a primary care field force hired through them by them because labor laws in Europe are complex and if you have too.

Change course or make any changes can be very very difficult.

From a profit, but also with cost implications so.

Based on that agreement that field force contract with and now so we just decided that since we're still in negotiation not to extend and not to continue but to suspend at this point in time, because it will get us to see if a good six months of <unk>.

Investments in that field force looking at the German situation now will have to see how the negotiations are going to evolve or are we going to be successful and come back to the primary care field force and that allows us to do whatever we want right with flexibility or this situation would remain very very difficult and then we would consider everything from.

Exiting the market or having minimal presence depending on what agreements we reached with the Germans.

We took advantage of the moment.

As a reminder, at the same time, we hired every our full team in the UK I would say a bit ahead of time, so in a way that balances our investment. So we knew we could save in Germany, and we knew that we could invest earlier in the UK by taking those two acts.

Together, we are in a way of normalizing.

Doesn't have it.

Additional UK investments don't hit Us that's hard painful saving in Germany, having said that investing more in Europe is good news because it means we have more reimbursement. So we look forward to invest more but for the moment.

That is the wisest thing to do and the time being until we see how the German negotiations will take place.

Operator: Thank you very much, ladies and gentlemen.

Finishing up on Sweden, and the UK, Sweden, and the UK are in launch mode.

In those two countries once you have national reimbursement.

You basically have a phase where you have to get formulary inclusion. So you have to make sure that on the regional and local formularies. The product is listed so NHS because they were very excited about the product committed to have the product listed on NHS formularies within three months, which puts the official launch date for it.

The UK for October so, we're very pleased with this and that.

We're making every effort to ensure that the product will be on the formulary, but also that as budget allocated to it which is the third most important step as a reminder, when a product gets approved mid year or toward year end, it's not that fast that they can allocate budget because the financing cycle. So you tend to have.

A bit of a slow uptake during the first few months in one year, but in the new year. Then there is a budget allocated for you. So that physicians know that they can freely prescribe.

Operator: The floor is now open for questions.

We're very excited about the launch in the U K and Sweden, we now have a full team in the U K incredibly talented with very significant cardio metabolic experiences.

At every level. So we're very encouraged and we look forward to share more progress on the launch over the next few quarters. Thank you Juan.

Great. Thanks.

Operator: If you have any questions or comments, please press star 1 on your phone handset at this, time.

Your next question is coming from Daniel <unk> of J P. Morgan Daniel over to you.

Operator: We ask that while posing your question, you please pick up your handset if listening on, a speakerphone to provide optimum sound quality.

Operator: Please hold while we poll for questions.

Good morning, everyone. Thanks for taking my question a couple of questions here first in the U S. Can you quantify for us the benefit for this quarter.

Operator: Thank you.

Operator: Your first question is coming from Michael Yee of Jefferies.

Potentially derived from the normalization and trade Destocking, we've seen in <unk>.

And I can follow up.

Georgi Nguyen: Michael, please ask... Hi, good morning.

Yeah.

Sure. Thank you and welcome back.

Georgi Nguyen: This is Georgi Nguyen on the line for Michael E. Thanks for taking, my question.

Georgi Nguyen: I guess a couple for me.

So on.

We cannot really articulate it in the second quarter as a benefit in reality there was a destocking in Q1 and it hit.

Georgi Nguyen: First, can you comment on the US sales trajectory going forward and how you expect EU sales to pick up?

Which was normalized this quarter right. So this is this is really how it is analyzed its not like there is.

Georgi Nguyen: Appreciating that you are getting reimbursement decisions right now in that region for 2022, so maybe a comment on how we should think about 2023.

Artificial benefit this quarter in fact, this is the first quarter, where we see prescriptions and volatile.

Really aligned so we feel confident that would a balance where we are today and the hit that we've seen in the Q1 has been basically normalized where do we think moving forward, we hope that would've not going to see any of these disturbances in the trade you can never speculate I think the market overreacted.

A third genetic and we're not surprised right.

Usually in a generic market you have older genetics coming in together on the first month, so you'd actually see situations, where you have six months with one genetic then another six month with the second genetic then a third genetic coming in literally after a year and three months so.

Yes, the wholesalers reacted we understand that but I think now they see that.

That the erosion or the volume progression of the genetics in general is the linear no matter how many.

They are on the market and we continue as a reminder to retain 60% of the <unk>.

Market, despite a year and a half.

Of of genetic presence, which I believe the U S team is very proud of.

Georgi Nguyen: And secondly, I might have missed that part, but could you elaborate on the supplier agreement amendments and the unsalable inventory?

Got it thank you and then focusing on the Europe .

Right.

On Germany can you provide us with a bit more color on the ongoing discussion with the health authorities there what the process entails and what exactly are the possible outcomes that are expected. When the project comes to completion in November and then switching to U K, while there might be a slow uptake in 2022 less you might actually have described discussed.

Georgi Nguyen: And also, do you expect this to happen again in the future?

Georgi Nguyen: And maybe lastly, appreciating your focus on the development of a fixed-dose combination, but in parallel, could you comment on your BD efforts as well, since I recall that you have plans to enlist some assets in the metabolic area?

And you said budgeting not being allocated how should we expect the launch to look like in 2023, and what are some of the dynamics at play that would shape the launch trajectory.

Sure. So on Germany, we are now in I would say the final stages of negotiation with GK view with the payer.

If if those negotiations come we come to an agreement then then that would and maybe in a month or so and if that doesn't then there is an additional opportunity for an arbitration that would take you until end of November .

That's why we decided since things are still ongoing.

And we clearly see based on the market dynamics the situation in Germany, not for us, but for everybody is incredibly challenging.

In terms of health care that are unprecedented decisions on controlling healthcare budgets and so on so we thought that the wisest thing is to just save money right.

Save money. This is conserve cash and make sure we save this money waiting for a final decision now if by November or by end of this month, we see.

A positive decision then we will.

Very easily rebuild because we have the contracts of our teams and we can we can reinitiate that but if not then than we would have in a way.

Restructured and save the money with very very minimal.

Costs Slash labor law impact so oldest scenarios on the table, we can speculate at this point in time.

I have disclosed before that in the UK, which was a very successful negotiation at the end we went through.

A third round of negotiation, which is very very uncommon in the UK and it.

He has given a positive result, we can speculate or say that that's going to be the same in Germany, but the message is we continue fighting and we continue negotiating until the last minute we have in the process.

For the UK.

We if you remember we decided not to invest in any country ahead of reimbursement to ensure we don't burn cash to prematurely now in the UK. We have a final decision we have a full team onboard those.

This team is on the field, where we are today and working very hard for us to have a strong launch.

23 is going to be a full year for them.

We have huge efforts in scientific engagement to build the awareness and the adoption. We believe the UK launch will be a good proxy of what we can deliver at a European level because there is significant adoption, we've actually seen tweets by NHS.

Health by other thing that excited to reimburse the product for their patients in the U K, which is unheard of so we feel encouraged and we're doing everything possible to drive to drive that moving forward.

Georgi Nguyen: Thank you.

Got it helpful. Thank you very much.

Yes.

Kareem Mikhail: Well, thank you.

Thank you. Our final question is coming from K crews of Goldman Sachs.

Kareem Mikhail: We'll try to take them one by one.

Kareem Mikhail: Let's just start with the US trajectory.

Hi, Thank you for taking my questions. This is Kate on for Paul.

Kareem Mikhail: First of all, we're pleased that this quarter we've seen our revenues to be in line with what, we've had in Q1.

Kareem Mikhail: If you really analyze this performance, you'll see that from a volume perspective, we are declining in the 7-8% prescription versus the Q1 of 2022, which is what is expected.

We have to we wanted to know how you were thinking about planning for potentially recessionary environment. Both in the U S and the U. In addition to the restructuring if theres any steps you're going to take.

Kareem Mikhail: So this is really in line with expectations.

Number two was how do you think about the margins for the U S business going forward post restructuring. Thank you so much.

Kareem Mikhail: At the same time, we also continue to have a price impact because we're losing volume in the non-exclusive segment where we have lower rebates. But this is more or less getting to a stabilization because now most of our business is really coming from the exclusive business.

Okay. Thank you.

So.

I think.

The environment is very challenging now overall it was tough for us as a company.

Kareem Mikhail: So over time, yes, we anticipate obviously a Q3 decline because it's seasonal and because we have a volume, but we see the price erosion over time, over the next two to three quarters, stabilizing in a certain way.

The last year in any case and again as a reminder, we did implement two restructuring already so we had one in October of 2021, then we had the second one in June of 2022. So we've been very proactive so far to be on top of our cost structure and I can tell you where to go.

So in quarter by quarter looking at our contribution margin because that for us the most important kpis we look at.

The key actions we've taken we are proactive to ensure we will be able to deliver future contribution margin that is needed for us to self fund at the same time, we keep our finger on the pulse if we see that the market conditions, you've seen us taking action in Germany right.

We are ready to take further actions if need be for the moment, we don't see that happening because I believe we've done a pretty significant effort in the last restructuring with almost 40% of.

Headcount impacted in the company right.

Ahead of ahead of all those headwinds.

But you never know how the market is going to shape. So we continue to be vigilant and we will react if need be.

The last question was on margin, yes on margins.

In the U S. I mean look I mean, we've had a one time impact on our margin this quarter.

We don't see this being repeated.

Just to see how things evolve, but if there are any additional one time.

In fact it is.

It's possible, but we don't see that as a trend Tom you want to add anything.

With that we were contribution margin positive again in the quarter.

And we'll continue to do so in order to invest into the European and the rest of our market.

Alright. Thanks.

Thanks, Tom.

Any further question okay.

Okay. We don't have any further questions in the queue I'll now hand back to <unk>.

Gary if he has any final questions.

Kareem Mikhail: So we're pleased with this quarter.

Well I just wanted to thank everyone for the call today, we believe we've had a strong quarter with significant success in the U K and Sweden. Our U S performance is on track and is delivering the contribution margin that we expect so we continue to move forward.

Kareem Mikhail: We continue to monitor the situation very closely and we'll see how things are going to evolve.

Kareem Mikhail: In terms of Europe, I'm going to try to address like two, three questions in one.

Kareem Mikhail: For the moment, 2022 is the year for reimbursement in Europe.

Kareem Mikhail: That's not our revenue generation here.

Kareem Mikhail: The focus today is to get as many countries, but more, importantly, at the right price.

Kareem Mikhail: And you've seen the team delivering very strongly on that promise with a final net price in the UK of around $176. It's significantly higher than our net price in the US, even prior to any price erosion, totally in line with what we committed to at the beginning of our European journey. The UK is known to be a challenging market from a pricing reimbursement perspective.

Kareem Mikhail: So the fact that they came out and they came out as our second country gives us confidence that that's really, that's the trend, that that's what we're going to be delivering over time.

Kareem Mikhail: It takes a little bit more time, obviously, to get to that level of net price, but we're engaged with all of the payers and negotiations continue.

Tom Riley: So we have worked, we've worked diligently with this supplier to ensure that the proper, procedures are in place to mitigate this in the future.

Kareem Mikhail: 2023 is going to be the revenue generation year.

Kareem Mikhail: This is the year where we're going to have at least six markets launching by year-end 2022.

Kareem Mikhail: So the remaining will launch in 2023.

Kareem Mikhail: So this is when we switch from pricing reimbursement to true revenue generation in probably 10 of the markets at that point in time.

Kareem Mikhail: On questions regarding supplier contract amendments, I'll start, but also let Tom share more detail.

Kareem Mikhail: We had a choice between, after we've seen the Q1 results and the significant shift in the US business, either to take a year to 18 months to adjust inventory level, because this is a very long lead manufacturing process. And if we took down that route, we would burn a lot of cash by the time we fix it.

Kareem Mikhail: So we decided to renegotiate with our suppliers so that we can find arrangements.

Tom Riley: So that's the situation.

Kareem Mikhail: So Tom.

Tom Riley: Yeah, Kareem, just to follow up, so it's multiple, we have multiple arrangements, long lead time, on the product.

Tom Riley: We see this as a good first step to stabilizing our working capital related to inventory, and we'll continue to work with our suppliers moving forward to make sure that we stabilize the supply purchases to reflect existing demand.

Forward and we look forward to share more progress and update with you and the next quarter. Thank you all for being on the call. Thank you.

Tom Riley: Okay, and I think the second question was related to the inventory charge of approximately, $10 million, which we had incurred this quarter. So just to give a little background, this charge was a result of inventory that was, damaged by one of our third party suppliers and caused the inventory not to be up to our quality standards.

Tom Riley: Thank you, Tom.

Kareem Mikhail: On the fixed post combination, you know, we continue, as you've seen, despite the fact, that we streamlined investments in terms of development to ensure that we keep the project, you know, active and ongoing, because we believe there is significant opportunity of having a fixed post combination on the market, but we decided to focus only on one statin.

Georgi Nguyen: Thank you for the question.

Kareem Mikhail: We made progress, we're in the, you know, we're in the phase of, you know, prototype, manufacturing and getting ready, you know, for, for, for, you know, next steps.

Georgi Nguyen: Thank you.

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

Kareem Mikhail: And you know, our BD position remains as such.

Georgi Nguyen: Very helpful.

Kareem Mikhail: We continue, you know, looking for, you know, assets that will provide, you know, U.S. revenue, and a U.S. asset for us and for the great team we have in the U.S. to focus on, on top of, on top of the SIPA.

Georgi Nguyen: Thank you.

Kareem Mikhail: But we're also open to other opportunities, so we'll see how that is going to evolve over, time.

Operator: Thank you so much.

Operator: The next question is coming from Louise Chen of Kantor.

Louise Chen: Louise, please ask your question.

Kareem Mikhail: Thank you and welcome.

Louise Chen: Hi.

Kareem Mikhail: Sure.

Louise Chen: Good morning.

Louise Chen: Congratulations on all the progress this quarter, and thanks for taking my questions.

Louise Chen: So I wanted to ask you about your SG&A in the third and fourth quarter, given your cost, reduction program.

Louise Chen: How should we think about it relative to second quarter if you can't give exact numbers?

Louise Chen: And then secondly, just on the sales, the nuance in the third and fourth quarter, because, just, I guess, during the first half of the year, we got a lot of questions on how to think about sales and if they're going to be up or down quarter over quarter.

Louise Chen: So any color you could give or any thoughts on the cadence or nuances would be very helpful.

Louise Chen: And the last question I had was just, Tom, as the new CFO, you know, what do you want, to bring to Ameren, and how will you do things differently at the organization going forward?

Louise Chen: Thank you.

Kareem Mikhail: Thank you, Louise.

Kareem Mikhail: So we can start with the SG&A, and then basically from there, I can give it to Tom to continue.

Kareem Mikhail: So if you remember, we implemented our restructuring really in June. So most of the benefits in terms of, you know, cost reductions are really going to start, to be seen from Q3, Q4, and the first half of next year.

Kareem Mikhail: And the split may be in the range of $50 million this year, $50 million next year.

Kareem Mikhail: But that's really at a high level.

Tom Riley: Tom, you want to add to that?

Tom Riley: Related to the savings?

Tom Riley: Yeah.

Tom Riley: Yeah.

Tom Riley: So we, as we mentioned earlier in the court, none of the, results or the savings were reflected in the Q2 results. So we expect overall that we'll have over $100 million of savings related to these cost reductions over the next 12 months, and they'll be spread over the next 12 months.

Tom Riley: Okay.

Tom Riley: And then, Louise, I think you had a question related to me being the new CFO.

Tom Riley: So overall, I'm very excited to be at Amarin, like every other CFO looking for to drive the function to be best in class.

Tom Riley: So that's number one focus or a focus.

Tom Riley: I think overall, what we see is to stabilize U.S. continued contribution margin in the U.S. so that we can support overall the European investments and really grow the company through a European and an international base.

Tom Riley: That gets me very excited.

Tom Riley: I'm glad to join Amarin to deliver on that.

Tom Riley: Thank you, Tom.

Kareem Mikhail: Just to go back, because I think there, was also a question on the cadence on the U.S. revenue and what to expect over the next quarter.

Kareem Mikhail: So as we said, we've seen within the exclusive segment, which is now the large majority of our, business, a stabilization in volume, if not a sort of single digit growth in volume. So we feel fairly confident that we are keeping track on that one.

Kareem Mikhail: We continue to see price erosion and the non-exclusive, we continue to lose volume obviously there, but this impact is slowing over time.

Kareem Mikhail: Obviously Q3, there is a seasonality.

Kareem Mikhail: So overall, we continue to focus on contribution margin. This is the number one driver of our efforts in the U.S.

Kareem Mikhail: The U.S. is delivering a very significant contribution margin that is supporting the organization drive, European business and our investments in the regulatory approvals globally.

Kareem Mikhail: So for the moment, from a contribution margin, we continue to deliver on target and we'll keep the effort.

Kareem Mikhail: Thank you, Louise.

Louise Chen: Thank you.

Operator: Your next question is coming from Rowana Ruiz of SVB Securities.

Roanna Ruiz: Rowana, please ask your question.

Roanna Ruiz: Great, thanks.

Roanna Ruiz: Good morning, everyone.

Roanna Ruiz: So maybe focusing on the Europe front, two questions for me.

Roanna Ruiz: I noticed you mentioned suspending the primary care field force in Germany.

Roanna Ruiz: And I'm curious, how might that impact or benefit your overall spend and how long do you, plan to keep this suspension in place?

Roanna Ruiz: And also, what's focusing on Sweden and the U.K. as newer countries coming online?

Roanna Ruiz: I was curious, what additional investments do you plan there and how do you see the outlook and spend for those countries as well?

Kareem Mikhail: Sure.

Kareem Mikhail: So in Germany, we chose very early on because we came very, very early to the German market to basically have a contractual agreement with a third party to have our primary care field force hired through them, by them, because labor laws in Europe are complex.

Kareem Mikhail: And if you have to change course or make any changes, it can be very, very difficult from a process, but also with cost implications.

Kareem Mikhail: So based on that agreement, you know, that field force contract would end now.

Kareem Mikhail: So we just decided, since we're still in negotiation, not to extend and not to continue, but to suspend at this point in time, because it will get us to save a good six months of, you know, investments in that field force looking at the German situation.

Kareem Mikhail: Now, we'll have to see how the negotiations are going to evolve.

Kareem Mikhail: Are we going to, you know, be successful and, you know, come back to the primary care field force, and that allows us to do whatever we want, right, with flexibility, or the situation would remain very, very difficult, and then we would consider everything from exiting to the market or, you know, having minimal presence, depending on what agreements we reach with the Germans.

Kareem Mikhail: So we took advantage of the moment.

Kareem Mikhail: As a reminder, at the same time, we hired every, you know, our, full team in the UK, I would say, a bit ahead of time.

Kareem Mikhail: So in a way, that balances our, you know, investment.

Kareem Mikhail: So we knew we could save in Germany, and we knew that we could invest earlier in the UK by taking those two actions together. We are, in a way, normalizing this so that it doesn't have, you know, the additional UK investments don't hit us that hard, since we're saving in Germany.

Kareem Mikhail: Having said that, investing more in Europe is good news, because this means we have more, reimbursements.

Kareem Mikhail: So we look forward to invest more.

Kareem Mikhail: But for the moment, that is the wisest thing to do in the time being until we see how the German negotiations will take place.

Kareem Mikhail: Finishing up on Sweden and the UK, Sweden and the UK are in launch mode. You know, in those two countries, once you have national reimbursement, You basically have a phase where you have to get formulary inclusion, so you have to, make sure that on the regional and local formularies the product is listed.

Kareem Mikhail: So NHS, because they were very excited about the product, committed to have the product, listed on NHS formularies within three months, which puts the official launch date for the UK for October.

Kareem Mikhail: So we're very pleased with this and, you know, we're making every effort to ensure that the, product will be on the formulary, but also there is budget allocated to it, which is the third most important step.

Kareem Mikhail: As a reminder, when a product gets approved mid-year or toward year-end, it's not that, fast that they can allocate budget because of financing cycles. So you tend to have a bit of a slow uptake during the first few months in one year, but, in the new year, then there is a budget allocated for you so that physicians know that they can freely prescribe.

Kareem Mikhail: We're very excited about the launch in the UK and Sweden. We now have a full team in the UK, incredibly talented with very significant cardiometabolic, experiences at every level.

Kareem Mikhail: So we're very encouraged and we look forward to share more progress on the launch over, the next few quarters.

Kareem Mikhail: Thank you, Rwana.

Roanna Ruiz: Great.

Roanna Ruiz: Thanks.

Operator: Your next question is coming from Daniel Wool of J.P. Morgan.

Daniel Wool: Daniel, over to you.

Daniel Wool: Good morning, everyone.

Daniel Wool: Thanks for taking our question.

Daniel Wool: A couple of questions here.

Daniel Wool: First, in the U.S., can you quantify for us the benefit for this quarter that could potentially, derive from the normalization and trade stocking seen in 1Q?

Daniel Wool: And I can follow up with the rest.

Kareem Mikhail: Sure.