Q2 2021 Amarin Corporation PLC Earnings Call

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Welcome to Amarin Corporation conference call to discuss its second quarter on 6 month 2021 financial results and operational updates. This conference call is being recorded today August 6.2021.

Operator: to Amarin Corporation's conference call to discuss its second quarter and six-month 2021 financial results and operational This conference call is being recorded today, August 5th, 2021. I would like to turn the conference call over to Michael Kalb, Chief Financial Officer at Amazon. Good morning, everyone, and thank you for joining us.

I would like to turn the conference call over to Michael Kalb, Chief Financial Officer at Amarin.

Good morning, everyone and thank you for joining us turning to slide 2 of the presentation accompanying today's call, which can be found in the Investor Relations section of our website at Www Dot Ameren Corp. Dot com. Please be aware that this conference call will contain forward looking statements that are intended to be covered under the safe.

Unknown Executive: Turning to slide 2 of the presentation accompanying today's call, which can be found in the Investor Relations section of our website at www.amarincorp.com, please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, these statements are based on, our goals carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements. However, actual results or events could differ materially.

Harbor provided by the private Securities Litigation Reform Act. Examples of such statements include but are not limited to these statements are based on information available to US today August 5.2021, 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.

Unknown Executive: 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 agreements that we may enter into, amend, or terminate. For additional information concerning the factors that could cause actual results to differ materially, please see the Risk Factors section of our quarterly report on Form 10-Q for the quarter ended June 30, 2021, and our annual report on Form 10-K for the year ended December 31, 2020, which have been filed with the SEC and are available through the Investor Relations sections of our website at www.amarincorp.com.

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 agreements that we may enter into.

To amend or terminate.

For additional information concerning the factors that could cause actual results to differ materially. Please see the risk factors section of our quarterly report on form 10-Q for the quarter ended June 30th 2021, and our annual report on form 10-K for the year ended December 31.2020.

Which have been filed with the FCC and are available through the Investor relations sections of our website at Www Dot Ameren Corp Dot com.

Unknown Executive: We encourage everyone to read these documents. This call is intended for investors in Amarin and is not intended to promote the use of a SIPA outside its approved indications. An archive of this call will be posted on Amarin's website within the Investor Relations section. Kareem Mikhail, Amarin's President and Chief Executive Officer, will lead our discussion, and I will provide a more detailed review of our financial results. After prepared remarks, we will open the call to your questions.

Encourage everyone to read these documents. This call is intended for investors in Amarin and is not intended to promote the use of vascepa outside its improved indications.

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

Kareem Mechelle Amarin, President and Chief Executive Officer will lead our discussion and I will provide a more detailed review of our financial results. After prepared remarks, we will open the call to your questions.

Unknown Executive: I remind you that multiple audiences typically listen to calls of this nature.

I remind you that multiple audience is typically listen to calls of this nature, including existing investors potential new investors employees current and potential collaborators and current and potential competitors as always in this call. We will attempt to provide constructive information without compromising our competitive.

Unknown Executive: Including Existing Investors, Potential New Investors, Employees, Current and Potential Collaborators, and Current and Potential Competitors. As always, on this call, we will attempt to provide constructive information without compromising our competitive and strategic positioning.

And strategic positioning.

Unknown Executive: I now turn the call over to Kareem Mikhail for a review of the business.

Now I'll turn the call over to Crema Cal for a view of the business.

Good morning, and thank you all for joining us this morning, I'm, particularly pleased to be addressing you for the first time as the president and CEO of Amarin following John throw his planned retirement, which officially took place earlier this week.

Kareem Mikhail: Good morning, and thank you all for joining us this morning. I'm particularly pleased to be addressing you for the first time as the President and CEO of Amarin. Following John Thoreau's planned retirement, which officially took place earlier this year, on behalf of the entire Amarin team, I'd like to thank John for his considerable contributions to the company and to patient care around the world. We wish him much success and happiness as he embarks on his retirement following his distinguished career as the President and CEO of Amarin.

On behalf of the entire Amarin team I'd like to thank John for his considerable contributions for the company and to patient care around the world. We wish him much success and happiness as he embarks on his retirement following his distinguished career as the president and CEO of family.

I joined Amarin is senior Vice President and head of commercial for Europe.

Kareem Mikhail: I joined Amarin as Senior Vice President and Head of Commercial for Europe approximately one year ago because I was attracted by the magnitude of the evidence in the REDUCED study and excited by the tremendous European opportunity we have to change the treatment paradigm in preventative cardiovascular care. Turn to slide three, please.

Similarly, 1 year ago, because I was attracted by the magnitude of the evidence in the reduce it study and excited by the tremendous European opportunity, we have to change the treatment paradigm in preventative cardiovascular care.

Turning to slide 3 please developing and commercializing cardio metabolic assets is a daunting mission and many companies stepped away from the space due to 2 main challenges.

Kareem Mikhail: Developing and commercializing cardiometabolic acids is a daunting mission, and many companies have stepped away from this space due to two main challenges. First, for numerous indications, you need cardiovascular outcomes data, which take years to generate and are a challenge to fund. And second, in order to ensure that as many patients can benefit from the new CV drug, you need to reach a broad prescribing audience. With the REDUCE-IT study, Amarin has already succeeded in developing the first and only approved medication for reducing cardiovascular risk beyond LDL-lowering therapies in high-risk statin-treated patients. This foundational scientific rigor is the main driver for the consistent recognition by 19 global medical societies of the latest edition of the American College of Cardiology.

First for numerous indications you need cardiovascular outcomes data, which take years to generate and are a challenge to fun and second in order to ensure that as many patients can benefit from the use of your drug you need to reach a broad prescribing audience with.

With the reduce it study amarin has already succeeded in developing the first and only approved medication for reducing cardiovascular risk beyond LDL lowering therapies in high risk statin treated patients.

This foundational scientific rigor is the main driver for the consistent for recognition of 19 global medical societies with the latest edition of the American College of Cardiology.

Kareem Mikhail: In terms of broad prescriber reach, Amarin has established a go-to-market model in Europe that allows us to reach larger prescribing audiences through efficient omni-channel engagements that amplify our essential field force efforts, and Amarin is leading the way in terms of innovation in this area. Our overarching goal for this exciting and new chapter of Amarin's future is to drive profitable growth, primarily by unlocking the vast potential of VASIPA and VASCEPA to reduce cardiovascular risk worldwide.

In terms of broad prescriber reach.

Amarin has established a go to market model in Europe that allows us to reach larger prescribing audiences through efficient omni channel engagements that amplify our essential field force efforts and Amarin is leading the way in terms of innovation in this space.

Our overarching goal for this exciting new chapter of Amarin future is to drive our profitable growth primarily by unlocking the vast potential of vascepa, our skipper to reduce cardiovascular risk worldwide, but before I share with you my vision and our plans for the future.

Kareem Mikhail: But before I share with you my vision and our plans for the future, let me first update you on our progress in general, and more specifically in the US, Europe, and the rest of the world. Turning to slide number four.

Sure. Let me first update you on our progress in general and more specifically in the U S Europe and the rest of the world.

Turning to slide number 4.

Kareem Mikhail: Starting with our revenue growth during the quarter, as you saw in our press release this morning, we reported a net total revenue for the second quarter of 2021 of $154.5 million compared to $135.3 million in the same period in 2020. The bulk of this revenue is from U.S. product sales of the CPAC. Importantly, and as Mike will discuss later in this call, our US FACEPA franchise is profitable and, along with our strong balance sheet, continues to support our growth and expansion.

Starting with our revenue growth during the quarter as you saw on our press release. This morning, we reported a net total revenue for the second quarter of 2021 of $154.5 million compared to $135.3 million in the same period in 2020.

The bulk of this revenue is from U S product sales of Vascepa importantly, and as Mike will discuss later in this call. Our U S. Vascepa franchise is profitable and along with our strong balance sheet continues to support our growth and expansion plans.

Kareem Mikhail: Now, more specifically in the U.S., we remain focused on execution and driving VASIPA growth in the U.S., as there continue to be millions of at-risk patients whose cardiovascular risk is untreated and who are candidates for the cardioprotective benefits of VASIPA. The sales increase this quarter is encouraging and a good start toward reinvigorating the SIPA growth in the U.S. A May 2021 Harris-Paul survey of more than 2,500 people, including subsets of people with diabetes and or heart disease, as well as cardiologists, primary care physicians, and pharmacists, conducted on behalf of Amarin, showed that the COVID-19 pandemic has reduced the prevalence of in-person check-ins with healthcare And while in-person visits have increased after the introduction of vaccines, the poll results show that 62% of cardiologists and 70% of PCPs say that they are seeing fewer patients in person than before the pandemic.

Now more specifically in the U S. We remain focused on execution and driving vascepa growth in the U S. As there continues to be millions of at risk for patients, whose cardiovascular risk is untreated and who are candidates for the cardio protective benefits for vascepa.

The sales increase this quarter is encouraging and a good start toward reinvigorating vascepa growth in the U S.

And they 2021 Harris poll survey of more than 2500 people.

Moving subsets of people with diabetes and heart disease, as well as cardiologists and primary care physicians and pharmacists.

Inducted on behalf of Amarin showed that COVID-19 pandemic has reduced the prevalence of in person check ins with health care professionals with approximately 1 third of the general adult population adult.

Adult diabetes patients and heart disease patients.

Boyden seeing health care professionals due to the fear of contracting COVID-19.

And while in person visits have increased after the introduction of vaccines. The poll results shows that 62 per cent of cardiologist and 70% of P. C piece.

Say that they are seeing fewer patients in person than before the pandemic.

Kareem Mikhail: As vaccinations take hold in the U.S. and COVID-19 recedes, with the hope that market recovery will not be further disrupted by the COVID-19 resurgence driven by the Delta variant, we see a significant opportunity to generate additional awareness. We never had the chance to build with the pandemic hitting during our first launch quarter and to drive the much-needed demand for Vasipa in the cardiovascular risk reduction indication.

As vaccination stake hold in the U S and COVID-19 proceeds with the whole debt market recovery will not be further disrupted by the COVID-19 resurgence driven by the Delta Varian, we see a significant opportunity to generate additional awareness, we never had the chance to build.

With the pandemic hitting during our first launch quarter and to drive the much needed demand for vascepa in the cardiovascular risk reduction indication.

Kareem Mikhail: Due to possible lasting changes that COVID-19 brought to the market, we are planning to achieve our objectives in a different and new way moving forward. While technological advances over the past several years have provided the tools to modernize sales and marketing activities to enhance their impact and efficiency, the COVID-19 pandemic has accelerated the adoption of such technologies.

Due to possible lasting changes that COVID-19 brought to the market. We are planning to achieve our objectives in a different and new way moving forward.

While technological advances over the past several years have provided the tools to modernize sales and marketing activities to enhance their impact on efficiency. The COVID-19 pandemic has accelerated the adoption of such technologies and those advances are now playing a central role in from a <unk>.

Kareem Mikhail: And those advances are now playing a central role in pharmaceutical sales and marketing, and we believe they will continue to do so after the COVID-19 pandemic is behind us. Moving forward, we intend to significantly increase the use and integration of these robust technologies. Digital Omnichannel Platforms to enhance our reach and customer engagement and improve efficiencies as we advance our branded and unbranded educational and promotional efforts to drive HCP and patient use of branded Visepa in the U.S. Turning to slide five, please, to address our unique market challenges in the U.S., we must engage effectively and efficiently with all four key stakeholders in the market. Firstly, physician.

Sales and marketing and we believe they will continue to do so after the COVID-19 pandemic is behind us.

Moving forward, we intend to significantly increase the use and integration of these robust digital omni channel platforms to enhance our reach and customer engagement and improve efficiencies as we advance our branded and unbranded educational and promotional efforts to drive H C. P.

And patient shoes on.

Branded vascepa in the U S.

Turning to slide 5 please.

To address our unique market challenges in the U S. We must engage effectively and efficiently with all for key stakeholders in the market.

Firstly physicians, we continue to inform and reinforce the unprecedented reduce it results. The broad managed care access debt branded Vascepa is the only available product F. D. A approved for cardiovascular risk reduction in at risk patients with elevated triglyceride.

Kareem Mikhail: We continue to inform and reinforce the unprecedented reduced results, the broad managed care access that branded Visepa is the only available product FDA approved for cardiovascular risk reduction in at-risk patients with elevated triglycerides, that generics do not have an approval for the cardiovascular risk reduction indication, and that the FDA revoked the indication of older triglyceride-lowering classes such as phenofibrates with statin to reduce cardiovascular risk. Secondly, with payers, we continue to make inroads with additional favorable managed care wins and enhancements that help to validate the SIPA value proposition in persistent cardiovascular risk. And thirdly, pharmacists.

Good day.

Debt generics do not have an approval for the cardiovascular risk reduction indication and that the F. D. A revoke the indication of older triglyceride lowering classes such as you know for grades with Stat, then to reduce cardiovascular risk.

Secondly, with payers, we continue to make inroads with additional favorable managed care wins and enhancements that help to validate the vascepa value preposition and persistent cardiovascular risk.

Thirdly, pharmacists, we have been working with major national and regional chains to ensure that CV risk patients opt in proper F. D. A approved vascepa. Many of these major chains have confirmed significant difficulties and disruption as a result of limited.

Kareem Mikhail: We have been working with major national and regional chains to ensure that CV-risk patients obtain proper FDA-approved Visepa. Many of these major chains have confirmed significant difficulties and disruption as a result of limited, inconsistent supply of generic IPE. This disruption has not only caused patients to leave the pharmacy without needed medication, but pharmacy retailers have faced lost sales.

And supply of generic IP.

This disruption has not only cause patients to leave the pharmacy without needed medication, but the pharmacy retailers have faced lost sales.

Kareem Mikhail: In addition, we are working diligently within the total prescribing ecosystem to ensure that all references, such as the Key Compendia, retail pharmacy systems, and e-prescribing platforms, used by HCPs accurately reflect the VASIPA cardiovascular risk reduction indication and importantly understand that generic products do not share this indication and are limited to lowering triglycerides in patients with triglycerides equal to or above 500 mg per deciliter Finally, with persistent CV risk patients, we are working to efficiently educate patients about the benefits of Vaseepa and drive patients to ask their doctors about Vaseepa, especially when they search out information on statins, triglycerides, and CV risk reduction. We also inform them that Vaseepa is widely covered by Medicare and commercial providers and that our $9 for 90 days supply co-pay program for commercially insured patients is still available to them.

In addition, we are working diligently within the total prescribing ecosystem to ensure that all references such as the key companion retail pharmacy systems and E. Prescribing platforms used by H C piece.

Currently reflect the vascepa cardiovascular risk reduction indication and importantly understand that the generic products do not share for this indication and are limited to lowering triglycerides in patients with triglycerides equal to or above 500 milligrams per deciliter, which is effectively less.

<unk> 10 per cent of the patients in need of Vascepa for.

Finally, with persistent C D risk patients we are working to efficiently educate patients about the benefits of vascepa to drive patients to ask their doctor about vascepa, especially when they search out information on Stephens triglyceride CV risk reduction. We also informed them that Vascepa is widely cup.

For it by Medicare and commercial providers and that our 9 dollar for 90 day supply co pay program for commercially insured patients is still available to them.

We remain confident in the potential for growth of Vascepa in the U S. Even with the entry of generic competition, thus far generic penetration in the market is around 12% of the IP market not you would expected generic erosion, which at this point, if the SIPA where a typical.

Kareem Mikhail: We remain confident in the potential for growth of Vaseepa in the U.S., even with the entry of generic competition. Thus far, generic penetration in the market is around 12% of the IPE market, not to mention your expected generic erosion, which at this point, if Vaseepa were a typical product with generic entry, would have exceeded 90% months ago.

Product with genetic entry would have exceeded 90 per cent months ago. We believe we have the opportunity and that is our obligation to continue to educate the market about the benefits of Vascepa and continue to drive demand I will share more about how we will do this differently later in the call.

Kareem Mikhail: We believe we have the opportunity, and that is our obligation, to continue to educate the market about the benefits of Vaseepa and continue to drive demand. I will share more about how we will do this differently later in the call when I discuss my vision and future plans. Now, looking at our very exciting opportunity in Europe, turn to slide six, please.

When I discuss my vision and future plans.

Looking now to our very exciting opportunity in Europe, turning to slide 6 please.

Kareem Mikhail: As in the U.S., the need for effective cardiovascular preventative care across Europe is significant. We see the European market opportunity as at least equal to or potentially larger than the U.S. It usually takes an agile biopharma company 2-3 years to establish itself in Europe and prepare for a product launch. The Amarin team established its presence in 15 European countries in what I consider a record time, and we now have employees covering 10 of the top 15 markets, with the very large majority of our team based in Germany, as we prepare for our first country launch.

As in the U S. The need for effective cardiovascular preventative care across Europe is significant we see the European market opportunity at least as equal to or potentially larger than the U S. It usually takes an agile biopharma company 2 to 3 years to establish itself in Europe.

And prepare for product launch the Amarin team established its presence in 15 European countries and what I consider a record time and we now have employees covering 10 of the top 15 markets with the very large majority of our team based in Germany as we prepare for our first.

Country launch.

Kareem Mikhail: Outside of Germany, we have a limited core team in each large country or cluster of countries focusing on market access success and scientific engagement. Moving forward, we will not be adding additional commercial roles in any country until we see the green light for reimbursement on the horizon. This staged rollout allows us to control the timing of our investment as to when and where we can have an immediate impact to drive revenue. We believe this model will best position us to achieve our goal to maximize SCEPA's reach in Europe and to become profitable on a country-by-country basis as soon as possible.

Outside of Germany, we have a limited core team and each large country or cluster of countries focusing on market access success and scientific engagement.

Moving forward, we will not be adding additional commercial roles in any country until we see the green light for reimbursement on the horizon.

The staged rollout allows us to control the timing of our investment as to when and where we can have immediate impact to drive revenue. We believe this model will best position us to achieve our goal to maximize the skipper reach in Europe and to become profitable on a.

Country by country basis as soon as possible.

Despite the limited time, we have to prepare the market, we expect to have strong sequenced country launches and overtime solid adult adoption as we continue to educate European audiences on the value of us Kipp.

Kareem Mikhail: Despite the limited time we had to prepare the market, we expect to have strong, sequential country launches and, over time, solid adoption as we continue to educate European audiences on the value of basketball. Its broad label and the fact that it's the only approved medication for cardiovascular risk reduction beyond LDL treatments in Europe. We previously communicated that our goal was to file 10 market access dossiers by year-end, and I'm proud to report that we submitted these dossiers in four important markets. The markets are the United Kingdom, France, Italy, and Denmark. The German dossier will be ready for submission just prior to the launch date in September 2021. This was a big accomplishment in a short period of time.

Its broad label and the fact that it's the only approved medication for cardiovascular risk reduction beyond LDL treatments in Europe.

We previously communicated that our goal is to file 10 market access dossiers by year end and I'm proud to report that we submitted these dossiers and for important markets. The markets are the United Kingdom, France, Italy, and Denmark, the German dose he is ready for submission jus.

Prior to the launch date in September 'twenty 'twenty 1.

This was a big accomplishments in a short period of time these.

Kareem Mikhail: These submissions are extensive and include data demonstrating the uniqueness of VASCEPA from a scientific perspective, as well as various country-specific demographic datasets to define the eligible patient population based on the label and the targeted list price of approximately 200 euros or $240 monthly. This price is proposed based on a value-based strategy, and we believe it is justified based on the demonstrated clinical effectiveness of the scapegoat, the high economic burden, and societal cost of heart attacks, strokes, and other cardiovascular events that VASCEPA can help avoid.

These submissions are extensive and include the data demonstrating the uniqueness of Vascepa from a scientific perspective, various country specific demographic data sets to define the eligible patient population based on the label and the targeted list pricing of approximately 200 euros.

<unk> or $240 monthly.

This price is proposed based on a value based strategy and we believe is justified based on the demonstrated clinical effectiveness of escape.

The high economic burden and societal cost of heart attacks strokes and other cardiovascular events that skip I can help avoid.

Kareem Mikhail: After the first 10 countries have submitted for market access, we plan to pursue a second wave of reimbursement filings in other European countries. We also plan to implement an agency distributorship model in most Central and Eastern European markets, where it does not make business sense for us to have our own Amarin presence. Now that you have the big picture for Europe, let me share more details about our German law.

After their first 10 countries submissions for market access we plan to pursue a second wave of reimbursement filings in other European countries. We also plan to implement an agency distributorship model in most central and eastern European markets.

But it does not make business sense for us to have our own amarin presence.

Now that you have the big picture for Europe, Let me share more details about our German launch.

Kareem Mikhail: In preparation for this launch, we have hired a seasoned German team and have deployed a field force of approximately 150 sales reps to advance pre-launch disease and brand awareness initiatives. As a reminder, based on EMA rules, Amarin could not promote the product nor mention the trade name until the EC approval date in April 2021. Additionally, and similar to the U.S., access to German physicians is still limited as the fight against COVID-19 continues despite increasing vaccination rates.

In preparation for this launch we have hired the season German team and have deployed a field force of approximately 150 sales reps to advance prelaunch disease and brand awareness initiatives. As a reminder, based on M. I rules amarin could not promote the product not to mention the trade name.

Until the E C approval date in April 'twenty 'twenty 1.

Additionally, and similar to the U S access to German physician is still limited as the fight against COVID-19 continues despite increasing vaccination rates.

Kareem Mikhail: Our team is making every effort to reach our target audience both physically and virtually as we prepare for the launch. We are ready to officially launch in September, where we will debut our rollout with a dynamic launch event. The event will be led by 9 leading key opinion leaders, who will highlight the scientific underpinnings and clinical benefits of VASCEPA to reduce cardiovascular risk before an audience of approximately 200 German specialists in Berlin. This is the maximum attendance allowed by the current German guidelines for in-person events.

Our team is making every effort to reach our target audience, both physically and virtually as we prepare for the launch.

We are ready to officially launch in September where we will debut our rollout with a dynamic launch event day event will be led by 9 leading key opinion leaders, who will highlight the scientific underpinnings and clinical benefits for skip hop to reduce cardiovascular risk before an audience of a pre.

Similarly, 200 German specialists in Berlin.

This is the maximum attendance allowed by current German guideline for in person events. In addition, the event will be offered as a live broadcast with the possibility to reach thousands of physicians in Germany and across Europe.

Kareem Mikhail: In addition, the event will be offered as a live broadcast with the possibility to reach thousands of physicians in Germany and across Europe. The timing of our German launch falls immediately on the heels of the European Society of Cardiology annual meeting taking place the last week of August and into early September. This global meeting will provide a great backdrop for us to highlight VASKIPA's benefits through a series of scientific and clinical presentations.

The timing of our German launch polls immediately on the heels of the European Society of Cardiology annual meeting taking place the last week of August and into early September.

This global meeting, we will provide a great backdrop for us to highlight the escape us benefit through a series of scientific and clinical presentations. In addition, and that it will have a considerable presence at this virtual meeting with our digital platforms for engagement will be showcased in our exhibit booth.

Kareem Mikhail: In addition, Amarin will have a considerable presence at this virtual meeting, where our digital platforms for engagement will be showcased at our exhibit booth, product theater, and more. The combination of the ESC meeting and the launch event provides an ideal opportunity to amplify our messages before audiences of reading cardiologists in our target markets with compelling clinical data in support of the use of VASCEPA to reduce cardiovascular risk. As we develop our European omni-channel engagement go-to-market model, we will complement all efforts by intensifying our digital channels to accelerate and enhance customer engagement and ultimately to drive awareness of the need to treat CV risk and the benefits of vasculature.

Product theater and more.

The combination of the ESC meeting and the launch event provide an ideal opportunity to amplify out of messages before audiences of leading cardiologist in our target markets with compelling clinical data in support of the use of let's skip on to reduce cardiovascular risk.

As we developed our European Omni channel engagement go to market model, we will be complimenting all efforts by intensifying, our digital channels to accelerate and enhance customer engagement and ultimately to drive awareness of the need to treat C D risk and the benefits of escape to reduce.

It.

Kareem Mikhail: As we are launching in the last few months of 2021, 2022 will be the first launch year where we will have one year of German revenue and, hopefully, multiple additional countries joining the European launch list. This is an exciting opportunity for Amarin to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event. I'm also excited to announce that Laurent Abouaf will be succeeding me as Senior Vice President and President for Europe.

As we are launching in the last few months of 'twenty 'twenty 1.

'twenty 'twenty 2 will be the first launch year, what we will have 1 year of German revenue and hopefully multiple additional countries joining the European launch leak.

This is an exciting opportunity for amarin to make a difference in the lives of the many millions of patients throughout Europe, who are at risk of a cardiovascular event.

I'm also excited to announce that for the whole Abu F will be succeeding me as senior Vice President and President for Europe low.

Kareem Mikhail: Laurent is a seasoned leader with significant cardiometabolic experience from his time at AstraZeneca. He has experience in large, medium, and small-sized markets in both Europe and Asia, and I'm confident that he is the right person to pick up the baton and lead Amarin for a big win in Europe. Now, let me turn your attention to the rest of the world.

He is a seasoned leader with significant cardio metabolic experience from his time at Astrazeneca. He has experience in large medium and small sized markets in both Europe, and Asia and I'm confident that he is the right leader to pick up the baton and lead Amarin for a big win in Europe.

Finally, let me turn your attention to the rest of the world.

Kareem Mikhail: In China, our partner, Edding, has made progress and still expects to receive approval from the SIPA in Mainland China and Hong Kong near the end of 2021, with these approvals adding plans to launch in these territories in 2022. As in the U.S. and Europe, VASIPA will launch with the support of the two key Chinese cardiology societies. With the burden of CV disease in China, and with two branded statins collectively selling more than $1 billion, there is a significant medical need and a meaningful market opportunity for Vasipa in China. Turning now to slide 7, let me share with you my vision for Amarin and a glimpse of our plan. As I officially assumed my new leadership role only five days ago, these are still early days.

In China, our partner, adding has made progress and still expect to receive approval of vascepa in mainland China.

Hong Kong near the end of 'twenty 'twenty 1.

With these approvals, adding plans to launch in these territories in 2022.

As in the U S and Europe, Vascepa will launch with the support of the 2 key Chinese cardiology societies.

With the burden of CV disease in China, and with 2 brand at Stephens collectively selling more than $1 billion that is a significant medical need and a meaningful market opportunity for vascepa in China.

Turning now to slide 7 let me share with you on my vision for Amazon and a glimpse of our plants.

As I officially assumed my new leadership for only 5 days ago. These are still early days that said I am keen to share my excitement about the potential opportunities for growth and my confidence in Amazon's ability to deliver on these objectives.

Kareem Mikhail: That said, I am keen to share my excitement about the potential opportunities for growth and my confidence in Amarin's ability to deliver on these objectives. I envision Amarin growth will be delivered through three main directions on slide 7. Firstly, the breadth dimension or geographic expansion. We launched the Cardiovascular Risk Reduction Indication in the U.S. in the first quarter of 2020. Our first country launch in Europe is planned toward the end of the third quarter of 2021.

I envision amarin growth will be delivered through 3 main directions on slide 7.

Firstly, the breath dimension or geographic expansion, we launched the cardiovascular risk reduction indication in the U S. In the first quarter of 'twenty 'twenty.

Our first country launch in Europe is planned towards the end of the third quarter 'twenty 'twenty 1.

Kareem Mikhail: So we have already embarked on this journey of global expansion, but now we want to take this to a different level. Our vision is to bring the cardioprotective benefits of VASEPA, VASKEPA, to patients worldwide, specifically to what most Pharma Companies consider to be the top 50 global cardiometabolic market. Currently, we have access to approximately 30 of these between our North American, European, and Chinese efforts.

So we have already embarked on this journey of global expansion, but now we want to take this to a different level.

Our vision is to bring the cardio protective benefits of Vascepa vascepa to patients worldwide, specifically to what most pharma company consider to be the top 50 global cardio metabolic markets.

Currently we have access to approximately 30 of these between our North American European and Chinese efforts.

Kareem Mikhail: A new key priority moving forward is to ensure that we unlock the potential of the SIPA and the balance of these markets, including Australia, New Zealand, select Latin American, and additional Asian markets. We plan to initiate the regulatory filing processes in a number of these markets in the coming months. We have the clinical data to support these submissions and expect the regulatory review and approval times to range from 6 to 18 months from submission, depending on the market. In many of these markets, we may not choose to be present ourselves and have already received requests for agency distributorship partnerships.

And you keep priority moving forward is to ensure that we unlock the potential of Vascepa and the balance of these markets, including Australia, and New Zealand select Latin American and additional Asian markets.

We plan to initiate a regulatory filing processes in a number of these markets in the coming months.

We have the clinical data to support these submissions and expect the regulatory review and approval times to range from 6 to 18 months from submission depending on the market.

And many of these markets, we may not choose to be present ourselves and have already received request for agency distributorship partnerships such collaborations have the advantage of giving us control over the marketing authorization of our product and providing optionality as we grow the business globally.

Kareem Mikhail: Such collaborations have the advantage of giving us control over the marketing authorization of our product and providing optionality as we grow the business globally. Collectively, this international expansion gives us access to another billion-dollar market opportunity for Amarin to leverage while making a difference in the lives of many millions of patients across the globe. Secondly, the height dimension or diversification.

Collectively this international expansion gives us access to another $1 billion market opportunity for amarin to leverage while making a difference in the lives of many millions of patients across the globe.

Secondly, the height dimension or diversification.

Kareem Mikhail: With our strong presence in the U.S. and the global expansion of the SIPA underway, Amarin has invested in building commercial infrastructure across the globe, which has created a great commercial asset for our company. We believe this asset makes Amarin an extremely attractive candidate for commercial partnership. While our primary focus is squarely on growing branded Vaseepa in the U.S., building Vaskepa in Europe, and globally expanding the opportunity for Vaseepa in other international markets, we plan not to waste any opportunity that will allow us to leverage the investment in our global commercial infrastructure.

With our strong presence in the U S and the global expansion of Vascepa underway Amarin has invested in building commercial infrastructure across the globe, which has created a great commercial assets for our company.

We believe this asset makes amarin and extremely attractive candidate for commercial partnerships.

While our primary focus is squarely on growing branded vascepa in the U S building, let's skip out in Europe and globally, expanding the opportunity for Vascepa in other international markets, we plan not to waste any opportunity that will allow us to leverage the investment in our global commercial infrastructure.

Kareem Mikhail: The first work stream we are prioritizing is our own life cycle planning for the CPI. Icosapent ethyl has proven to be a beneficial molecule in a number of clinical settings, and we are actively evaluating other potential research settings in which to further explore and characterize the drug's activity.

The first work stream, we are prioritizing is out on lifecycle planning for Vascepa.

So pent Apple has proven to be a beneficial molecule and a number of clinical settings, and we are actively evaluating other potential research settings in which to further explore and characterize the drugs activity and these efforts will align with clinical and commercial needs across individuals and global Mark.

Kareem Mikhail: And these efforts will align with clinical and commercial needs across individual and global markets for the brand. The second work stream we are prioritizing is our business development effort. We have been active in the BD space, but we intend to intensify, accelerate, and bolster our BD program. This is an opportunity to capitalize on the commercial and R&D infrastructure and expertise we already have in-house. Let me remind you that such efforts require time, both because there are few true value-creating opportunities and because we need to be very selective as to where we focus to ensure we continue to drive shareholder value.

That's for the brand.

The second work stream, we are prioritizing our business development effort, we have been active in the BD space, but we intend to intensify accelerate and bolster our BD program. This is an opportunity to capitalize on the commercial and R&D infrastructure and expertise we.

We already have in house, let me remind you that such efforts required time, both because there are few true value, creating opportunities and because we need to be very selective as to where do we focus to ensure we continue to drive shareholder value.

Kareem Mikhail: Thirdly, the depth dimension or go-to-market and operational evolution. The pharmaceutical market has been evolving for several years, and now, with COVID-19, we have arrived at the tipping point.

Thirdly, the depth dimension or go to market and operational evolution.

The pharmaceutical market has been evolving for several years and now with COVID-19, we arrived at the tipping point.

Kareem Mikhail: Access to physicians is becoming more and more limited via traditional channels, and the significance and impact of payers are increasing. The role of the pharmacist is becoming more central to care delivery, and, more importantly, patients need support to seek and adhere to therapies and solutions that will impact their health positively. So it is critical for us to rethink our go-to-market model and to continue to evolve. We need to ensure that we are both effective and efficient in the way we run our operations. Prioritize our choices among various key stakeholders and the different channels we use to engage with our customers.

Access to physicians is becoming more and more limited via traditional channels and the significance on impact of payers is increasing debt all of the pharmacist is becoming more central with the complexity of care delivery and more importantly patients need support to seek and EBITDA to therapies and.

Solutions that will impact their health positively.

So it is critical for us to rethink our go to market model and to continue to evolve. It we need to ensure that we are both effective and efficient in the way we get on our operation prioritize our choices among various key stakeholders and the different channels, we use to engage with us.

Our customers are.

Kareem Mikhail: Earnestly revisiting what we are doing, why we are doing it, and how we are doing it is key to this effort. Our evolved, orchestrated engagement model provides us with the breadth and depth of interaction we need to drive awareness, adoption, and consistent usage in order to deliver growth. Finally, let me share some perspective on the timelines for executing on our three growth dimensions. Evolving the go-to-market model is immediate, and the model we implemented in Europe is already aligned with this vision. When we look at our global expansion efforts, some of these are short-term, such as our imminent launch in Germany. Many other European countries, along with our international expansion plans discussed today, will be more medium-term.

Ernest theory, visiting what we are doing why we are doing it and how what are we doing it is key to this effort I would evolved orchestrate that engagement model provides us with the breadth and depth of interaction we need to drive awareness adoption and consistent usage in order to deliver.

For growth.

Finally, let me share some perspective on the timelines for executing on our 3 growth dimensions.

Evolving the go to market model is immediate and the model we implemented in Europe is already aligned with this vision when we look at our global expansion efforts. Some of these are short term such as our imminent launch in Germany. Many other European countries, along with our international expansion plans.

Today, we will be more medium term finally, although our diversification effort is very active and ongoing these initiatives tend to take more time and requires substantial diligence to ensure they will add to shareholder value.

Kareem Mikhail: Finally, although our diversification effort is very active and ongoing, these initiatives tend to take more time and require substantial diligence to ensure they will add true shareholder value. With this overview of our vision and plans for the future, let me turn the call over to Mike Culp, our CFO, for a more ad-detailed discussion of our financials. Mike?

With this overview of our vision and plans for the future. Let me turn the call over to Mike Kalb, our CFO for a more detailed discussion of our financials Mike.

Mike Kalb: Thanks. Turning now to slide eight. During the second quarter of 2021, we reported net product revenue of $153.8 million, an increase of 15% compared with the second quarter of 2020, and we achieved $295.2 million in the first six months of 2021, an increase of 3% over the same period in 2020. As Karim noted, these increases were largely driven by increased U.S. Visepa sales and occurred despite the ongoing impact of the COVID-19 pandemic and the impact of generic products for Visepa's initial indication.

Thanks cream, turning now to slide 8 turning to the second quarter of 2021, and we reported net product revenue of $153.8 million, an increase of 15 per cent compared with the second quarter of 2020, and we achieved $295.2 million for the for.

First 6 months from 2021, an increase of 3% over the same period in 2020.

As cream noted these increases were largely driven by increased U S. Vascepa cells and occurred despite the ongoing impact of the COVID-19, pandemic and the impact of generic products for Vascepa as initial indication.

We expect that net selling price may slightly decline in the second half of 2021, as we continue to be opportunistic and protecting and expanding our managed care access in light of generic availability.

Mike Kalb: We expect that the net selling price may slightly decline in the second half of 2021 as we continue to be opportunistic in protecting and expanding our managed care access in light of generic availability. Signs of growth are encouraging, and plans to selectively increase promotional spend in the second half of the year should drive increased revenue growth. Absent the reversal of certain non-cash charges, we were approximately break-even in the second quarter of 2021.

Signs of growth are encouraging and plans to selectively increased promotional spend in the second half for the year should drive increased revenue growth.

Absent the reversal of certain noncash charges, we were approximately breakeven in the second quarter of 2021.

We are pleased that we were able to achieve this with our continued expense management and despite the limitations to our potential revenue growth, resulting from the continuing impact of the COVID-19 pandemic.

Mike Kalb: We are pleased that we were able to achieve this with our continued expense management and despite the limitations to our potential revenue growth resulting from the continuing impact of the COVID-19 pandemic and the resulting reduction in patient visits to their physicians, which impact new prescriptions. While a second generic launched in June, we remain confident in our ability to grow Visepa in the U.S. as this is an atypical generic market. We believe the growth in revenue in the second quarter of 2021 emphasizes the need for Visepa in the U.S. and the continued potential opportunity for Amarin in this market.

And the resulting reduction in patient visits to their physicians, which impact new prescriptions.

While a second generic launch in June we remain confident in our ability to grow vascepa in the U S. As this is an atypical generic market.

We believe the growth in revenue on the second quarter of 2021.

Emphasizes the need for Vascepa in the U S and the continued potential opportunity for amarin in this market.

Mike Kalb: This also further shows that we have cash flow and profitability through our U.S. operations. Sponsored ADR As of June 30, 2021, Amarin reported aggregate cash investments of $523.1 million, consisting of cash and cash equivalents of $327 million, and liquid short-term and long-term investments of $181.9 million and $14.2 million, respectively.

This also further shows that we have the cash flow on profitability through our U S operations to support the expansion into Europe and other geographies around the world. However, due to variability of spend related to go to market initiatives in the U S and expansion into Europe, our overall profitability on the short term may fluctuate.

As of June 32021.

Amarin reported aggregate cash and investments of $523.1 million, consisting of cash on cash equivalents of $327 million and liquid short term and long term investments of 181, 9 million and $14.2 million respectively.

Mike Kalb: We believe our current resources are sufficient to fund our projected operations, including a successful commercial launch in Europe. With that financial overview, I will now turn the call back to Karim for closing remarks. Thanks Mike for that financial overview. I'm turning now to slide 9. Our vision is clear, and our strategy is set. Our focus moving forward remains firmly on executing these plans with the return to growth of SEPA in the U.S., the successful launch of SEPA in Europe, and global expansion as our top priority. In closing, let me say that I'm honored and humbled to serve as Amarin's new CEO and to work alongside the dedicated and talented Amarin team to advance our mission.

We believe our current resources are sufficient to fund our projected operations, including a successful commercial launch in Europe.

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

Thanks, Mike for that financial overview, turning now to slide 9 our vision is clear and our strategy is set our focus moving forward remains firmly on executing these plans with debt he turned to growth of vascepa in the U S. The successful launch of Vascepa in Europe and the global.

<unk> is our top priorities in closing, let me say that I'm honored and humbled to serve as Amazon's, new CEO and to work alongside the dedicated and talented amarin team to advance our mission I greatly appreciate the overwhelmingly positive welcome I have received from many of.

Kareem Mikhail: I greatly appreciate the overwhelmingly positive welcome I have received from many of our loyal shareholders and analysts and will work diligently to earn your ongoing support as together we work to create value and lead a new paradigm in preventative cardiovascular care. With that, Operator, we are ready to open the call for questions. Thank you.

Our loyal shareholders and analysts and we'll work diligently to earn your ongoing support as together, we work to create value and lead the new paradigm in preventative cardiovascular care with that operator, we are ready to open the call for questions.

Thank you.

Operator: Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Once again, please press star 1 if you have any questions. Please hold while we poll for questions. The first question is coming from Ken Kachiatour from Cohen, and it can be your line of life.

Ladies and gentlemen, the floor is now opened for questions. If you have any questions or comments. Please press star 1 on your phone at this time.

We are so low pulls on your question you. Please pickup your handset is listening on speaker phone to provide optimum sand quality. Once again. Please press star 1 if you have any questions on please hold while we poll for questions.

The first question is coming from Ken Cacciatore from Cowen.

John Your line is nice.

Ken Kachiatour: Great, thanks so much. Congratulations on all the progress and congratulations to John on all his contribution.

Great. Thanks, so much congratulations on all the profit.

Progress and congratulations to John and all his contribution I'm just wanted to a.

Ken Kachiatour: Just wanted to follow up on the disclosure of the proposed list price. Can you just talk us through it mechanically when we know that we've secured it kind of in the various regions? So just timing around that and maybe a little bit of the back and forth interaction that you have as you negotiate this. And then in the U.S., I'm just wondering if, obviously, it's been a wonderful defense, and the generics have peaked out. Can you give us the balance?

Follow up on the disclosure of the proposed list price can you just talk us through on mechanically when we know that we've secured it kind of in the in the various regions. So just timing around that and maybe a little bit in the back and forth interaction that you have as you negotiate this and then in the U S.

Just wondering obviously, it's been a wonderful defense on the generics have peaked out can you give us the balance is it the raw material issues that you've cited previously or is it the label defense that you're articulating that is capping the generics in it and then maybe lastly, it does look like Teva has removed their M D.

Kareem Mikhail: Is it the raw material issues that you cited previously, or is it the label defense that you're articulating that is capping the generics? And then, maybe lastly, it does look like Teva has removed their NDA, or there is language suggesting as such on the FDA website. Can you just talk about future generics and expectations and timing? Thank you.

[noise] or there was language, suggesting as such on the FDA website can you just talk about future generics and expectations on timing. Thank you.

Kareem Mikhail: So let me start by talking about the proposed price in Europe. Clearly, this is the list price that we are making public at this point in time. This has been submitted to a number of countries as the initial step to start the negotiations. So, you know, you should think of this really as...

Thanks, Ken.

So let me start by talking about the proposed price in Europe.

Clearly.

Price that we are making public at this point in time.

Currently a number of countries.

The initial step to.

Start the negotiation.

You.

You shouldn't think of day to really add.

Kareem Mikhail: The first starting point of that journey; now, we believe that we have set this in a way to ensure that the different countries see the value and the price, and that they see that it's well justified within the patient population that we are targeting, and more importantly, the value that we are bringing. Now, the specific mechanics by country; in a country like Germany, this price is really going to be the price that we're going to be selling it for, minus two mandated single-digit rebates, but that's going to be the net price for the first year.

The first starting point on that journey now.

We set for this in a way to ensure that the different countries either value enterprise.

EBIT as well justified within that patient population.

More importantly, the value that we are bringing now.

Pacific mechanic by country in a country like Germany.

This is really going to be the price that we're gonna be selling with minded.

Men single digit.

But that is going to be the net price for the first year after that for here, we're going to happen.

Kareem Mikhail: After that first year, we're going to have an update of that price based on the negotiation, and in other countries, that negotiation is already ongoing on the price. So, when we launch, we would launch with a fully negotiated final price. Now, I remind you that price structure and price negotiation in Europe are very different than in the U.S. The rebates and the markups are very, very different, so comparisons between list prices in Europe and WAC in the U.S. may not be that useful at this stage.

Price based on day negotiation.

In the other countries.

She is already ongoing.

On the price.

When we would launch we would launch with a fully negotiated find on price.

Mind, you that price structure on price negotiation in Europe is very different than in the U S E Bay and the markups on very very different so you know.

Between list price in Europe.

Well it may not be that useful however, we stay.

Kareem Mikhail: However, we stay true to what we disclosed earlier, which is that our net price in Europe will be at the same level or higher than our net price in the U.S. Now, talking about the U.S. performance and how we are performing versus generics, I want to start by saying, I mean, clearly, this is a very unique situation and the fact that the team in the U.S. is able to retain 88% of the market despite Now, to account for that in one, two, or three different variables is very difficult, right? It is not one thing that is driving this level of retention of businesses.

True.

We share that wasn't that price in Europe would it be at the same level or higher than our net.

The U S.

No.

Talking about the U S performance on how are we performing versus generic.

I mean, clearly this is a very unique situation and the fact that the team in the U S is able to 18.8 per.

And on the market despite its doing genetics.

For many months it is a very very significant achievement now.

Oh for that too.

1.2 or 3.

Theyre for and valuable very difficult, Brian it's not 1 thing.

And driving.

This level of regaining of business. Obviously, you know first of first reason is the fact that you know.

Kareem Mikhail: Obviously, you know, the first reason is the fact that genetic suppliers are not, you know, able to supply the market and they are inconsistent. However, we clearly see that today they have 12% of the scripts, which we believe is higher than what is truly legally indicated as VHTG. Theoretically, if this was on indication promotion, they would have had 7%.

It seems that genetic suppliers are not able to supply them.

And they have inconsistent however, we clearly see that today they have for 12% of this credit.

Which we believe is higher than what is truly legally indicated.

Geographically if this was on on indication promotion day 7 per se.

Kareem Mikhail: But that's the first reason. The second, and most important, is the effort that the team has been doing over time, and we try to articulate this in the effort implemented at the physician level, at the payer level, at the pharmacy level, and at the patient level. There is not going to be one silver bullet that will solve this problem once and for all. We have to pursue the legal route, as we are, and as you know, we are pursuing the legal route of making sure that genetics do not go beyond what is legally approved in that indication, but we also pursue every other route to ensure that we educate the key stakeholders on the appropriate usage of a SIPA and its indication, which is not shared by the genetics.

The first reason.

Importantly for them.

You have been doing.

We try to articulate for it.

Physician level.

At the pharmacy level and at the patient level that is not going to be 1 silver bullet debt.

It's a problem once and for all we have 2 for Sundar you can go.

As we are and as you know we are pursuing the route of making sure that genetics do not go beyond what is.

Legally.

Vacation, but we also for every other routes to ensure.

Okay.

Yeah.

Usage of it.

Anything vacation, which did not share mm bye.

Kareem Mikhail: Now, in terms of, you know, Teva removed their AMDA and other elements. As you know, this is typical if a genetic company has not used and has not launched their product within six months of their approval, they basically get delisted, but they are able to be listed back if they decide to launch.

By by the genetics now in terms of you know.

And on that element.

Typical for generic company has not use debt has not launched.

You know debt.

Within 6 months of that approval.

Yeah.

They're able to be back if they decide to launch.

Kareem Mikhail: So, we have no further comments on that. Thank you. Next question. Thank you, and the next question is coming from Yasmeen Rahimi from Piper Sandler. Yasmeen, your line is live.

So we have no further comment on that.

Thanks for question.

Thank you and the next question is coming from Yasmin Rahimi from Piper Sandler You asked me your line is nice.

Yasmeen Rahimi: Hi Karim. Thank you so much for your thoughtful, prepared remarks. I wanted to understand a little bit more about the additional four dossiers that have been filed. I think if you could just help us understand the timing of those to be put into place and the additional six in terms of filing. And then also when we think about pricing outside of Germany, you know, there are certain geographies that are a little bit more, I guess, easier to negotiate versus other countries. So just kind of give us a little bit of color on timing and heterogeneity among the different 10 countries. That'd be very helpful. And thank you for taking my question.

Hi, Quinn.

Uh-huh prepared remarks.

I understand a little bit more on the additional work and see what happens.

Thank you.

If you could just help us understand the timing of those to be put into place.

Thanks.

Oh filing them and then on.

Right.

Germany.

Now.

And geography.

I guess easier to negotiate for other countries. So just kind of give us a little bit of color on timing heterogeneity different.

And 10 country that'd be very helpful and thank you for taking my question.

Kareem Mikhail: Thank you, Anthony. So we have submitted up to now four country dossiers. We said the UK, France, Italy, and Denmark. And the German dossier is ready for submission, has been ready for submission for a couple of months now. We're only basically keeping it until the right moment for a commercial launch because if we submit it too early, it means we have to sell it early. And because of the limitations of COVID and the limited access we have, we don't believe that it's the right moment. We believe that September is the right moment to launch in Germany after the summer.

So we.

We have supplemented now for country.

U K, France, Italy, and Denmark, and Germany. He is ready for submission has been ready for submission or for a couple of months now we're only basically keeping it until the right moment for <unk>.

Commercial loans, because if we submit it to me. It means we have to sell early and because of the limitation of Covid and the limited access we have we don't believe that it's the right moment, we believe that Denver is the right momentum launch in Germany.

Now each 1 of these countries.

Kareem Mikhail: Now, each one of these countries and the additional funds that we will submit has a different negotiation timeline. There is a group of countries that have a predetermined clock. So if you look at a country like the UK, where most of the discussions and negotiations are actually public, so you can go to the NICE website and see what type of interactions we have with NICE, you will see that this is a process that will take, from an HTA perspective, somewhere between 12 to 15 months, taking into account two or three back-and-forth committee meetings to negotiate the price. Now, there are products that do that or delivered It really depends on the evidence that you have, and the appetite of the reimbursement body to say, yes, I need this.

Additional debt.

Has it different negotiation timeline.

Both countries have a pre determined clock. So if you look at a country like the U K, which most of the discussion.

On the negotiations is actually public. So you can go on the NYC website and see what type of interactions. We have with night, you'll see that this is a process that will take from an HCM perspective somewhere between 12 to 15.

Taking into account tour feedback back and forth for me.

Ooh negotiated the price now that our products.

On a deliberate.

Earlier than this timeline it really depends on.

That you have the EBITDA.

Oh, the reimbursement, but you can say yes.

Debt.

Kareem Mikhail: Specifically in the UK, we've seen that the market has been far more sensitive to the need for cardiovascular products in the UK recently, so we believe that that's a positive note. Having said that, it's a significant budget impact for the UK, so they will take all the time they need to negotiate access and price for their population. However, scientifically speaking, they recognize the value.

It's likely in the U K, we've seen that the market has been far more.

For the need for cash.

Thanks.

In the U K.

Although there's no having said that.

But you're getting back for it so they will take all the time they need to negotiate access on the price for that population. However.

Speaking day recognized now as I said different countries have different timelines that all countries in the northeast that have a 90 day clock. There are countries that have a 180 day clock and you've seen us.

Kareem Mikhail: Now, as I said, different countries have different timelines. There are countries in the Nordics that have a 90-day clock. There are countries that have a 180-day clock.

Kareem Mikhail: And you've seen us not go in a sequenced way. We don't go to the UK and say, let's get the UK done, and then we can move to Italy. No, no; we are submitting in parallel a number of countries because we know that the negotiations will evolve very differently in the different countries and we have to pursue all of them at the same time. I also want to add that we are not going to leave one stone unturned in getting earlier access before complete national reimbursement.

Not going in it.

Okay.

We don't know the UK every day that gets.

Okay.

No no we are submitting in parallel.

Countries, because we know that day negotiation with you for.

Good day.

Our country and we have to pursue all of them at the same day.

Also on our debt.

We are not.

Once I'm done.

Yeah.

For complete national reimbursement, so there maybe a couple of countries, where we can go for it.

Kareem Mikhail: So there may be a couple of countries where we can go for what is called individual reimbursement. So this is, you could see this almost as a pre-authorization, patient-by-patient basis, so we'll still give us access. It's not very critical in terms of revenue generation, but what it does is get physicians and patients in the habit of prescribing the product.

Hold on individual reimbursement.

You could see that.

For your authorization patient by patient basis.

So you gave us.

Very critical in terms of revenue generating.

Does it get the physicians and patients and bad debt.

Describing the product so it did those for Egypt.

Kareem Mikhail: So it is of strategic value, and we will pursue it in every country where there is an opportunity to actually do that. So that's in terms of what we submitted. Obviously, over the next six months, we are planning to submit five additional countries. So these are Spain, Sweden, Norway, and the Netherlands.

And we weighted for sure in every country.

That opportunity to actually do that so.

That's in terms of what we felt like it obviously over the next 6 months, we are planning to submit them for 5 additional countries for ESR, Spain, Sweden, Norway.

And the Netherlands, so and once we have that.

Kareem Mikhail: And once we have that, we're also prepared for the other waves that we submit. And as you can see, we are prioritizing countries by the size of the opportunity and by the likelihood of us achieving the targeted price the fastest possible. And of course, you know, we know that there are certain markets that take far longer than others. A country like France is very much known to be in the 15 to 18 months.

For the other way.

Got it.

Dial in country.

The size of the opportunity.

The likelihood of us.

Shaping targeted price.

As possible and of course, you know, we we know that there are certain markets.

Longer than others, a country like France are very much known to be in the 15 to 18 months. That's why we felt necessary early to ensure that we get enough time to negotiate with them.

Kareem Mikhail: So that's why we submitted very early to ensure that we get enough time to negotiate with them. So that's really, I hope this has provided enough detail and granularity on the pricing and the filing at the European level.

So that's really I I hope this has provided.

Your line is on the latter.

On the pricing on the filing.

I know you.

Operator: Thank you. Thank you. Any questions?

Okay.

That's very helpful.

Louise Alesandra Chen: Thank you. And the next question is coming from Louise Chen from Cantor. Louise, your line is live.

Thank you and the next question is coming from Louise Chen from Cantor Louise Your line is nice.

Kareem Mikhail: Hi, thanks for taking my questions here. The first question I have for you is, can you provide more color on where the $1 billion of incremental revenues are going to come from? Can you break it out maybe between EU and the rest of the world? And then how should we think about sales in the second half of this year in light of the EU launch in Germany and then also competition from generics here in the U.S., and there's been additional competitors?

Hi, Thanks for taking my questions here. So first question I have for you is can you provide more color on where that $1 billion on incremental revenues are going to come from can you break it out between you and the rest of the world.

And then how should we think about sales in the second half of the year in light of the EU launch in Germany, and then also competition from generics here in the U S and there's been an additional competitor.

Kareem Mikhail: And then last question is, have you had any discussions with EU partners recently and what type of partner are you looking for here? I think you had mentioned that you kind of keep all the options open, so just curious about your most recent thoughts. Thank you.

And then last question is have you had any discussions with your partners recently and what type of partner you're looking for here on I think you had mentioned that you can keep all the options open for just curious your most updated thoughts thinking.

Kareem Mikhail: Thank you, Louise. So let me first clarify the $1 billion. So the $1 billion that we quoted in the discussion just a few minutes ago was really an incremental $1 billion outside of the U.S. and outside of Europe, right? This is a new incremental revenue stream by pursuing an additional 20 countries on top of the 30 where we are. So if you look at North America, between the U.S. and Canada, you add Europe, right, 27, you add China, that's around 30 markets out of the top 50.

Thank you Louise So let me first clarify the $1 billion. So the 1 billion debt we called it.

The discussion.

A few minutes ago was really an incremental 1 billion outside the U S and outside.

Right.

You.

So revenue stream by.

Hi.

Assuming additional 20 countries on total.

We are so if you look at North America between USA, Canada and Europe.

So when you add China that's it on.

Market outlook.

Kareem Mikhail: There are 20 remaining countries where we believe we can have access and generate revenue. If you look at these countries, I think the most important ones would be countries like Australia and New Zealand. If you look at what other products have delivered within the cardiometabolic space in Australia and New Zealand, you'll see that this is a country that usually delivers a revenue size of the big five in Europe. So it's Germany, or it's Spain, or France.

Are you meeting.

Great.

We can have access and generates revenue. If you look at these countries I think the most important 1 would be countries like Australia and New Zealand.

If you look at what other products have delivered within the car.

Without wanting space in Australia, and New Zealand, you'll see that day.

This is a country that's usually delivered revenue.

Hi.

Big 5 in Europe.

And then Germany, or Spain, or France site.

Kareem Mikhail: In these countries, you know, we need to initiate a regulatory, you know, approval process. We are going to initiate that within the next month. And some of these countries have a rapid process, example, Australia and New Zealand, for example, where it's really six months, but some others take a far longer time.

In these countries.

We need to initiate a regulatory approval process, we are going to issue debt within.

The next month and some of these countries to have rapid profit example, Australia New Zealand for example, where it's really 6 months, but some other it takes far longer time and for me.

Kareem Mikhail: And to be specific about where those countries are, if you look at Latin America, countries like Mexico and Brazil, and if you look at Asia, countries like Korea are very important from a lipid market perspective and from a cardiovascular perspective. And in these countries, we believe we do not need to go there ourselves to build, you know, an infrastructure we can partner in a different evolved model that will allow us to sort of maintain our marketing authorization, maintain optionality, and continue to sort of drive our performance at a global level. So that's the answer on the incremental $1 billion outside of the U.S. and Europe. Now, thoughts on the second half of the year.

Specific on where those countries are if you look at Latin America, Mexico, Brazil, If you look at the Asia countries like Korea.

More than countries from a lipid market perspective, and a coffee.

And in these countries, we believe we do not need to go on sale.

To build.

From a structure weekend.

In a different model that would allow us to sort of maintain on marketing authorization maintain optionality and continuing to drive outperform.

Performance at school.

So that's the answer on the on the incremental.

1 billion outside of U S.

No thoughts on on the second half of the year today, we are really trying to accelerate every effort for our growth in the second half, having said that that for a number of unknowns right. We don't know where the delta is going to pick up and then whether you know this isn't going to impact that.

Kareem Mikhail: Today, we are really trying to accelerate every effort for our growth in the second half. Having said that, there are a number of unknowns, right? We don't know where the Delta variant is going to take us by year-end and whether, you know, this is going to impact access. Access in the U.S. today to physicians has been stagnant at 50% to 60% of physicians, not more than that. And also, you know, the impact on the patients visiting is still the same.

In the U S. The day to physician has been stagnant.

He presents for physician not more than that.

And you also.

On the patient is still the same we don't see that increasing in the very short term. So all the growth that we can drive is really by our own effort to accelerate the war and we intend to continue to drive through our field force efforts on managed care team.

Kareem Mikhail: We don't see that increasing in the very short term. So all the growth that we can drive is really our own effort to accelerate and do more. And we intend to continue to drive through our field force efforts, our managed care team, but also amplify our efforts via additional digital omnichannel efforts to ensure we reach more physicians. That's the challenge today, right? The market is more or less 50% closed.

Amplify our efforts by additional digital omni channel efforts to ensure we explore.

That's the jobs a day right the market is more or less for it.

And we need to find ways of accessing physicians tend to drive and to drive it.

Kareem Mikhail: And we need to find ways of accessing those physicians and driving the business. Discussions on partners are mostly around what we discussed for Central and Eastern Europe and for partnerships in the rest of the world, international markets, and they are more agency distributor type models. But, you know, we cannot comment further at this stage. But there is no discussion of, for example, partnering Europe at this stage because the plane is on the runway.

Cash and from partners.

Mostly out on what we discussed for central Eastern Europe, and for our partnerships and the rest of the World International markets and there are more in the Asian side.

Model.

We cannot comment further.

But there is no there is no discussion for for example, partnering.

H because the planes on the runway.

Kareem Mikhail: We have already submitted our prices. Actually, anything we do today may potentially be disruptive unless it's done in a very, very particular way. And we feel confident that we are on our way to a successful launch in Europe. Thank you.

That price is actually anything we each day.

That shouldn't be that from that in a very very probably thinking that way and we feel confident that we are on atwood way for successful launch.

Yeah.

Thank you.

Thank you.

Operator: Next question. The next question is coming from Michael Yee from Jefferies. Michael, your line is open. Hi, good morning. This is Mike on for, or sorry, this is Dennis on for Mike.

The next question is coming from Michael Yee from Jefferies. Michael Your line is lives.

Hi, Good morning. This is Mike on for Tim This.

This is Ben on for Mike Good morning, I, just have 2 quick questions.

Michael Yee: Good morning. I just have two quick questions. Dr. Reddy seems to be ramping up, and they said they aren't seeing any supply constraints. Do you feel like you have a good hold on your own supply chain? And can you comment on what you're seeing overall in the supply landscape? And then, as a follow-up, how should we think about expenses in the US and whether these will be the right size in the second half and 2022 as generics continue to improve? Thank you.

Nobody seems to be ramping up and they start they arent in any supply constraints do you feel like you have a good hold on your own supply chain and can you comment on what you're seeing overall on the supply landscape and then as a follow up.

How should we think about expenses in the U S can be bite size in the second half and 2022 as generics continue to ramp up.

Thank you so on E R L and the comments that they have no low supply issue as well.

Michael Yee: So on DRL and the comments that they have no, you know, no supply issues. Well, if a generic company stays true to the size of the indication for VHGG, well, that's 7% really of the total market, so that would not be an unexpected statement to make if you are trying to communicate that you are not infringing on somebody else's patents and rights. Now, to the reality of the supply, we definitely don't have any information.

If a generic company stays true to the size of the indication of ph D. G, 7% really of the total market so that would not be.

And unexpected statement to make is if you are trying to communicated that you are not infringing on somebody else's.

Bad debt and right.

No to the reality.

The supply we definitely don't have information on what we see is that supply from Hikma from.

Michael Yee: What we see is that supply from Hikma and from DRL is very sporadic and inconsistent. You know, it's focused on where we are selling, and that's really the disruption that it is creating today. That's the fight we are having. The challenge is not very much in the true substitution we're having. Only 12% of the business is substituted.

Very sporadic inconsistent.

You know it's focused on where we are.

And that's really the disruption day.

Hey, that's the fight we are happy.

The challenge is not very much indeed through substitution with having only 12% of the business is substituting our challenge is that this is creating a significant disruption in the market because the patient goes to the pharmacy, he or she does not get it for.

Kareem Mikhail: Our challenge is that this is creating a significant disruption in the market because the patient goes to the pharmacy. He or she does not get Fazepa branded, is told to wait a couple of days for a generic to be available, and two days later, is told to wait another two days, and at the end of the day, we lose many of our ongoing, continuing patients. If you look at the new-to-brand business, we are driving the new-to-brand. There are more new patients that are using Fazepa.

FIFA brand stores.

Total to wait a couple of basis for a generic to be available in 2 day stone to wait another 2 day to day.

We lose money on ongoing continuing patients.

The new to brand business, we are driving the need for brands that are more patient.

On Shannon.

Kareem Mikhail: Our challenge is that we're losing from this refill of the continuing business, but we believe we have the supply needed. We made every effort over many years to have enough supply for the U.S., for Europe, and today, as you can see, we have a plan beyond Europe, which, by the way, if you look at prior disclosures, is not new. We have always communicated that we would go international, outside of the U.S. and outside of Europe, once we have the price set in Europe, and since the price is set in Europe and we have communicated it publicly to a number of countries already, it is the time to go, and we believe we have the supply needed to successfully launch in these markets. Now we look at expenses. Toward the end of the year and next year.

If they fail.

Continuing on.

But we believe we have the supply on EBIT. We made every effort over many years, who have enough supply for the U S for Europe and today as you can see we have a plan beyond Europe, which by the way. If you look at the prior disclosure is not for you we have always communicated.

We wouldn't go international outside of the U S and outside of Europe. Once we have net price in Europe.

Price et cetera.

And we communicated publicly for number of countries already it is the time to go and we believe we have the supply needed to.

To successfully launch and in these markets now looking at expenses.

Towards the end of the year on next year, we are making every effort.

Kareem Mikhail: We are making every effort to be very selective with our investment rules, right? If you see that the market is already closed and you have limited access, you're not going to continue to repeat the same type of investment because it's not going to drive further growth. So today the question is not just the magnitude of the investment, not how much money; it's how we spend the money, right? So we could stay with the same level of expense but with a different mix.

Be very selective with our investments if.

If you see that the market is already closed and you have limited access.

You're not going to continue to repeat the same type of investment because its not going to drive further growth. So 2 day. The question. It's not just the magnitude of the investment how much money is how we spend the money right. So we could stay with the things that would've expected but.

With a different mix.

Kareem Mikhail: We believe we can drive growth. So we are very conscious that we need to look at our profitability simply because we want to continue to be able to finance our growth plan, right? So we keep balancing the act between the US, Europe, and ex-US to ensure we continue to be well-funded so that we would not need to go beyond our own capabilities in terms of financing to drive it further. Now, how will things evolve in 2022? I mean, it's too early to judge at this point in time.

Maybe we can drive growth. So we are very conscious that we need to look at our profitability.

Because we want to continue to be able to finance our growth.

So we we keep balance thank you.

Between U S Europe ex U S. We sure we continue to be it wasn't funded debt we would not for me to go beyond our own capabilities in terms of financing to drive. It further now how things evolved in 'twenty 'twenty 2 I mean, it's still early.

You can judge at this point in time, if we have access on a number of European countries. As I said, we tend to try to be profitable in many of these countries on a country by country basis.

Kareem Mikhail: If we have early access to a number of European countries, as I said, we intend to try to be profitable in many of these countries on a country-by-country basis early enough, but we continue to be excited and energized about the opportunity in the US. We still hold a very large minority of the business. Our number one priority is to drive growth in IP, right? If that growth was back and generics continued to have a similar share or even slightly higher, we would still be very profitable in the US, and we would continue to drive that.

But we continue to be excited and energized about the opportunity.

We still hold the very low.

The business our number 1 priority is to drive growth of IP right.

That growth is.

His back and genetics continue to have a similar share or even slightly higher we would still be very profitable in the U S and we will continue.

Operator: Thank you for your question. Thank you. And the next question is coming from Jessica Fye from J.P. Morgan. Jessica, your line is live.

Thank you for your question.

Yeah.

Thank you and the next question is coming from Jessica Fye from J P. Morgan Jessica on your line of lives.

Jessica Macomber Fye: Hey guys, good morning.

Yeah.

Kareem Mikhail: Can you just elaborate a little on the comments that the net selling price might decline in the back half as you aim to protect managed care access? Is that something we should also think about continuing into 2022 and beyond? I guess, what's the latest payer dynamic you're seeing that's driving this need to protect access? I kind of thought previously you'd indicated that wouldn't really be necessary based on SEPA's already low net price in the US.

So on.

On the call.

On the net selling price decline in the back half.

Do you aim to protect managed care access.

Is that something we should also think about continuing into.

'twenty 'twenty 2 and beyond.

The latest paradigm you on that you're seeing that's driving that thing.

I previously indicated.

Sorry.

It's already low net right.

Yeah.

Kareem Mikhail: Thanks, Louise. So, just commenting on the net price, if you look at our net price over the last many years, you'll see that the net price has been very stable. And, you know, we made sure that over time, we protected that. Today, there is a slightly different dynamic, and you see we're going to be, as we said, opportunistic because that's not going to be an overarching strategy. We're only going to do that when we believe it is. You know, business is meaningful and will drive access to a meaningful business opportunity.

Thanks, Louise so just commenting on on the net price if you look at our net price over the last many years.

You'll see that the net price has been very much stable and you know we made sure that overtime, we protected that day.

A slightly different dynamic and you see we're gonna be we said for sure. This bank because that's not going to be an overarching strategy, we're only going to do that we need.

You know business meaningful and will drive access.

On to a meaningful business opportunity I don't believe that that's going to be significant.

Kareem Mikhail: I don't believe that that's going to be significant at this stage, simply because we are retaining and even improving our access, you know, despite having the two genetics available. In fact, many payers recognize the lower net cost benefit of the CPAP. For the moment, we have very good coverage and, you know, at the market level. But we don't see this as a continuing consistent trend. We say we may need to do this from an opportunistic perspective and with a number of plans, but that's it, and we'll have to see how things evolve.

Because we are maintaining and even improving at axis.

Despite having the 2 genetics available in fact, many payers recognize net cost benefit of the feedback for the moment, we have very good coverage and.

You know.

At the market level.

We don't see day.

Consistent trend, we say we need to do this from.

Genetic perspective, and a number of plans, but that's it and we'll have to see how things evolve. We're also conscious to ensure that we keep price says.

Kareem Mikhail: We're also conscious of ensuring that prices are similar in different parts of the world. As you know, in Europe, we have European reference pricing. So we will try to maintain our price level as close as possible to each other and not lose a lot of our value in terms of price.

Similar between different parts of the World as you know in Europe, we have European reference pricing. So we would try to maintain them on a price level that's cool.

As possible 2 to each other and not lose a lot of our value in terms of instead of just price.

Jessica Macomber Fye: Great. And maybe just one more, I appreciate the kind of comments on how you're thinking about spend. Just to be clear, do you still expect OPEX to be in the guidance range that you provided earlier this year? So, you know, today, as you've seen from the first

Hum.

And maybe just 1 more and I appreciate the kind of comments on how you're thinking about spend mm hmm.

Just to be clear do you still expect opex to be in the guidance range that you provided earlier this year.

So you know today.

Kareem Mikhail: So, you know, today, as you've seen from the first two quarters, numbers have changed over time because we have to react to where the market is going and when the right time to invest is. In the first half of the year, we felt we needed to hold a little bit on some of our investments because we felt like it was not the right time. We believe that the second half seems to open up better, so we believe we're going to have more investments, both, you know, in the U.S. but outside of the U.S. also. And again, we continue to monitor the market situation and evolve, you know, our investment choices, quarter by quarter.

As you've seen from the first 2 quarters.

You know the numbers have changed over time, because we have to.

React to where the market is going and when it's the right time to invest the first half of the year, we felt we needed to hold a little bit on some of our investments because we felt like it was not the right time, we believe that the second half seems to open up.

So we believe we're going to have more investment growth.

You know and in the U S, but outside the U S. Also and again, we continue to monitor the market situation and any bolt on.

Our investment choices.

As you know quarter by quarter.

Operator: Great. Thank you. Thank you, and that's all the time we have for questions today. I would now like to turn the call back to Kareem Mikhail for any closing remarks. So I just want to thank you all for the warm welcome for this first quarter and this first earnings call. We look forward to continuing to working together and answering your questions, whether in quarterly calls or one-on-one. Thank you, Colin, and thank you all, and have a great day. Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

Right Mhm.

No.

Okay.

Thank you and that's all the time, we have for questions today I would now like to turn the call back to clean the pounds for any closing remarks.

So I just want to thank you all for.

For the warm welcome for US for this first quarter on this first earnings call.

Look forward to continue for working together on answering your questions whether on the quarterly calls on 101. Thank you Paul and thank you all and have a great day.

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