Q1 2021 Amarin Corporation PLC Earnings Call
Welcome to Amarin Corporation's conference call to discuss its first quarter 2021 financial results and operational updates.
Operator: Welcome to Amarin Corporation's conference call to discuss its first quarter 2021 financial results and operational updates. This conference call is being recorded today, April 29th, 2021. I would like to turn the conference call over to Alina Dubrovna, Associate Manager of Investor Relations at Amarin.
This conference call is being recorded today April 29 2021.
I would like to turn the conference call over to our lean into profit now associate manager of Investor Relations at Amarin.
Alina Dubrovna: Thank you, Operator, and thank you to everyone for joining us for our first quarter 2021 results. Before we begin, let me turn to our forward-looking statements. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of VISIPA prescriptions, VISIPA product and licensing revenues, costs, gross margin, and other commercial measures. Our current plans and expectations regarding spending, including expenditures for promotion of Visepa and for purchase of additional supplies of Visepa. Our current expectations regarding the adequacy of our financial research.
Thank you operator, and thank you to everyone for joining our first quarter 2021 results before we begin let me turn to our forward looking statements. Please be aware that this conference call will contain forward looking statements that are intended to be covered under the safe Harbor provided by the private Securities Litigation Reform Act.
Examples of such statements include but are not limited to.
Our current expectations regarding our commercial and financial performance, including levels of Vascepa prescriptions, Vascepa product and licensing revenues costs gross margin and other commercial metrics, our current plans and expectations regarding spending including expenditures for promotion of Vascepa and for purchase of.
Additional supply of Vascepa, our current expectations regarding the adequacy of our financial resources.
Our current plans and expectations for product revenue growth sales force productivity and product promotion in light of COVID-19, and the potential for added attention to cardiovascular risk reduction drugs like the seaport as a result of COVID-19, our current plans and expectations related to the pad.
Alina Dubrovna: Our current plans and expectations for product revenue growth, sales force productivity, and product promotion in light of COVID-19 and the potential for added attention to cardiovascular risk reduction drugs like the SEPA as a result of COVID-19. Our current plans and expectations related to patent litigation and expectations related to the potential supply and launch of generic versions of the SIPA by generic companies and by ourselves. Our current expectations for the substance and timing of the FEPA regulatory reviews outside the United States.
Litigation.
Rotation is related to the potential supply and launch of generic versions of vascepa by generic companies and by herself.
Our current expectations under substance and timing of Vascepa regulatory reviews outside the United States.
Alina Dubrovna: Our current plans and expectations regarding the timing, scope, and success of international expansion, including expectations regarding our ability to launch VizCepa in Europe and our expectations in China for clinical trial results and the potential to bridge reduced results in labeling and promotion of VizCepa through our partner in China. Our current plans and expectations regarding VizCepa exclusivity outside the United States, including Europe and China. Our current plans for commercial expansion in the United States with the entry of current and potential future generic competition and our current plans and expectations regarding clinical study of VizCepa related to COVID-19
Our current plans and expectations regarding the timing scope and success of international expansion, including expectations regarding our ability to launch Vascepa in Europe, and our expectation in China for clinical trial results and potential to bridge reduce it results in labeling and promotion of Vascepa through our parts.
In China.
Our current plans and expectations regarding vascepa exclusivity outside the United States, including Europe, and China. Our current plans for commercial expansion in the United States with the entry of current and potential future generic competition and our current plans and expectations regarding clinical study of Vascepa related to COVID-19.
These statements are based on information available to us today April 29th 2021 we may not actually achieve our goals carry out our plans or intentions or meet the expectations disclosed in our forward looking statements actual results or events could differ materially. So you should not place undue really.
Alina Dubrovna: These statements are based on information available to us today, April 29th, 2021. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place 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.
Alliance 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.
Alina Dubrovna: For additional information concerning the factors that could cause actual reserves to differ materially, please see the risk factors section of our quarterly report on Form 10-Q for the quarter ended March 31st, 2021, and our annual report on Form 10-K for the year ended December 31st, 2020, which have been filed with the SEC and are available through the investor relations section of our website at www.amarincorp.com. We encourage everyone to read these documents.
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 March 31st 2021, and our annual report on form 10-K for the year ended December 31st 20.
'twenty, which have been filed with the SEC and are available through the Investor Relations section of our website at Www Dot Ameren Corp. Dot com, we 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 of its approved.
Alina Dubrovna: This call is intended for investors in Amarin, and it is not intended to promote the use of a SIPA outside of its approved indication. An archive of this call will be posted on Amarin's website within the Investor Relations section. Making prepared remarks on today's call will be John Theroux, President and Chief Executive Officer, Kareem Mikhail, Senior Vice President and Head of Commercial for Europe and Plant Future, and Michael Kalb, Chief Financial Officer.
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An archive of this call will be posted on Amarin website within the Investor Relations section.
Prepared remarks on today's call will be John <unk>, President and Chief Executive Officer, covering Mikael Senior Vice President and head of commercial for Europe, and plant future, President and Chief Executive Officer, and Michael Cao Chief Financial Officer. After prepared remarks, we will open the call to your questions.
Alina Dubrovna: After prepared remarks, we will open the call to your questions. I remind you that multiple audiences typically listen to calls of this nature, including existing investors, potential new investors, employees, current and potential collaborators, and current and potential competitors. As always, on this call, we will attempt to provide constructive information without compromising our competitive and strategic position. I now turn the call over to John Tharo, President and Chief Executive Officer of Amarin.
I remind you the multiple audiences typically listen to calls of this nature, including existing investors potential new investors employees current and potential collaborators and current and potential competitors.
Always in this call we will attempt to provide constructive information without compromising our competitive and strategic positioning I now turn the call over to John <unk>, President and Chief Executive Officer of Amarin.
Good morning, and thank.
John Theroux: Good morning, and thank you all for joining us. As you know, we recently announced my plans to retire this year and for our Senior Vice President and Head of Commercial for Europe, Kareem Mikhail, to take over as President and CEO. Karim and I have spoken with a number of you over the past couple of weeks, and while announcing my retirement is a bittersweet moment for me,
Thank you all for joining us.
As you know, we recently announced my plans to retire this year and for our senior Vice President and head of commercial for Europe Korean Mikael to take over as President and CEO.
Cream and I have spoken with a number of you over the past couple of weeks.
And while announcing my retirement is a bittersweet moment for me.
John Theroux: I have every confidence in Amarin and its outstanding employees who are dedicated to the patients and shareholders we serve. Separately today, we announce that Joe Kennedy, our general counsel, has informed me of his intentions to retire from Amarin. Joe has played a pivotal role in the development of the company over the last decade, including in various past successful legal initiatives that have enduring value for Amarin and for the pharmaceutical industry. He is one of the small number of employees who joined Amarin prior to us gaining approval from the FDA for the initial indication of a SIPA in 2012 and at the start of the reduced study.
I have every confidence in amarin and its outstanding employees, who are dedicated to the patients and shareholders we serve.
Separately today, we announced that Joe Kennedy, Our General Counsel has informed amarin of intention to retire from Amarin. Joe has played a pivotal role in the development of the company over the last decade, including in various past successful legal initiatives, which have enduring value for amarin and for the fall.
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He is one of the small number of employees, who joined amarin prior to us gaining approval from the FDA from initial indication OSC, but in 2012 and at the start of the reduce it study Joe remains focused on amarin success and dedicated to work to ensure a smooth transition to our new general counsel and.
John Theroux: Joe remains focused on Amarin's success and dedicated to working to ensure a smooth transition to a new general counsel and plans to continue to support the company in certain legacy legal matters as part of his plan. Kareem, with the support of Joe and others at Amarin, including me, has commenced the search for a replacement general counsel for Amarin. The primary office location for the new General Counsel is likely to be our New Jersey office.
Plans to continue to support the company and certain legacy legal matters as part of its planned transition.
Claim with the support of Joe and others at Amarin, including me has commenced the search for replacement General counsel for Amarin.
The primary office location for the New General counsel is likely to be our New Jersey office for.
John Theroux: For context, of the more than 1,000 people currently working for Amarin, more than 80% joined our team in the past three years. Most of these people were added for the commercialization of VASIPA in the United States, or more recently, for commercialization of VASCEPA in Europe, or for managing our R&D initiatives, including the REDUCED study, which initiatives expanded after VASIPA was initially launched in 2013. Aside from Joe and me, only 14 of our employees were with Amarin prior to the initial approval of the SEPA.
For context of the more than 1000 people currently working for amarin more than 80% joined our team in the past three years. Most of these people were added for commercialization of Vascepa in the United States or more recently for commercialization of our skipper and Europe or from managing our R&D initiatives, including the reduce it study.
Which initiatives expanded after Vascepa was initially launched in 2013.
Aside from Joe and me only 14 of our employees will with amarin prior to the initial approval of Vascepa.
Recall that we got a small team of people prior to commercialization.
John Theroux: Recall that we had a small team of people prior to commercialization. In recent years, Amarin has had relatively little turnover and, particularly, little turnover among senior management. Accordingly, while it may seem odd that both Joe and I are retiring from the company in a similar time frame, we do not expect this to be a broadly recurring theme.
In recent years Amarin has had relatively little turnover and particularly little turnover among senior management.
Fortunately, while it may seem odd that both Joe and I are retiring from the company in a similar timeframe.
We do not expect this to be a broadly recurring theme.
Among our long tenured executive officers are Steve Ketchum and Aaron Berg.
John Theroux: Among our long-tenured executive officers are Steve Ketchum and Aaron Berg. They and various others have expressed their intentions to not retire at this time and to work with Careem to build a bigger and better Amarin. Towards that end, the Amarin team continued to make significant progress throughout the first quarter of 2021, highlighted by a number of achievements that support our international strategy to rethink cardiovascular risk. Most notably, we received marketing authorization from the European Commission for our unique drug, icosabinethyl, under the brand name Veskepa, for cardiovascular risk reduction. The brand name will remain Vasipa in the United States.
Day, and various others have expressed their intention to not retire at this time and to work with cream to build a bigger and better amarin.
Towards that end the amarin team continued to make significant progress throughout the first quarter of 2021 highlighted by a number of achievements that support our international strategy to rethink cardiovascular risk.
Most notably we received market authorization from the European Commission for our unique drug it goes to buy an apple on the brand name the skipper for cardiovascular risk reduction.
The brand name will remain vascepa in the United States.
The European marketing authorization is a major milestone for Amarin is it allows us to commence our commercial initiatives in Europe with the aim overtime of helping millions of at risk patients, which represents a multibillion dollar opportunity for amarin.
John Theroux: The European Marketing Authorization is a major milestone for Amarin as it allows us to commence our commercial initiatives in Europe with the aim, over time, of helping millions of at-risk patients, which represents a multi-billion dollar opportunity for Amarin. Just last week, the marketing authorization for Vescepa and Europe was expanded to cover England, Scotland, and Wales. These regulatory approvals reflect the robust results of our clinical studies and the hard and thoughtful work of our employees, in the support of various leading positions and other advisors.
Just last week, the marketing authorization for Vascepa in Europe was expanded to cover England, Scotland and Wales.
These regulatory approvals reflect the robust results of our clinical studies.
The hard and thoughtful work of our employees and the support of various leading positions and other advisors.
We are optimistic about our opportunities in Europe, and our next major step is market access.
John Theroux: We are optimistic about our opportunities in Europe, and our next major step is market access. We also remain excited about our opportunities in the United States and the rest of the world. Throughout the first quarter, we continued our work to build the Visepa brand in the US amidst the continued headwinds of the COVID-19 pandemic, as well as other events that impacted patients visiting their health care providers in certain areas of the country. We were not alone in facing these headwinds.
We also remain excited about our opportunities in the United States and the rest of the world.
Throughout the first quarter, we continued our work to build the Vascepa brand in the U S. Amidst the continued headwinds of the COVID-19 pandemic as well as other events that impacted patients visiting their health care providers and certain areas of the country.
We were not alone in facing these headwinds for example, COVID-19 appears to have slowed the growth in the use of statin and other lipid therapies.
John Theroux: For example, COVID appears to have slowed the growth and use of statins and other lipid therapies. Because of these headwinds, and to a lesser extent, because of the entry of limited generic competition, they elected to spend less on product promotion in the first quarter of 2021 compared to the first quarter of 2020, as a result of operational cost savings. Our bottom-line results improved in the first quarter of 2021, despite a modest and hopefully temporary decline in reported revenue.
Because of these headwinds and to a lesser extent because of the entry of limited generic competition.
We elected to spend less on product promotion in the first quarter of 2021 compared to the first quarter of 2020.
As a result of operational cost savings our bottom line results improved in the first quarter of 2021, despite a modest and hopefully temporary decline in reported revenue.
In the United States, our net product revenue for the three months ended March 31, 2021, and 2020 were $140 8 million and $145 5 million, respectively, a decrease of 3%.
John Theroux: In the United States, our net product revenue for the three months ended March 31, 2021 and 2020 was $140.8 million and $145.5 million, respectively, a decrease of 3%. This decrease was driven primarily by the effects of one, COVID-19. 2, Severe Weather and Related Power Outages in Various Parts of the United States.
This decrease was driven primarily by the effects of one <unk>.
COVID-19.
Two severe weather and related power outages in various parts of the United States.
John Theroux: 3, generic competition, and for effectively one fewer week of shipments in the first quarter of 2021 as compared to the first quarter of 2020, which, as reported in 2020, added approximately $10.8 million to net product revenue in the first quarter of 2020. This anomaly, as expected, was not repeated in 2021; however, net product revenue in the first quarter of 2021 was also impacted by our decision to reduce our level of promotional activity.
Three generic competition.
And for effectively one fewer week of shipments in the first quarter of 2021 as compared to the first quarter of 2020.
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As reported in 2020.
Added approximately $10 $8 million to net product revenue in the first quarter of 2020.
This anomaly as expected was not repeated in 2021.
Net product revenue in the first quarter of 2021 was also impacted by our decision to reduce our level of promotional activities.
By Cobb, our CFO will speak in more detail regarding these factors later in this call.
John Theroux: Mike Cobb, our CFO, will speak in more detail regarding these factors later in this call. We also know that the first quarter of each year is historically a challenge due to seasonal factors that are not FACEPA specific but rather impact many medications. In particular, in Q1 of each year, some patients elect to not fill their prescriptions due to beginning of the year deductible limits under their insurance plans. Such deductible limits go into effect at the beginning of each calendar year under many insurance plans, creating an added financial burden for patients.
We also know that the first quarter of each year is historically a challenge due to seasonal factors that are not vascepa specific but rather impact many medications.
In particular in Q1 of each year, some patients elect to not fill their prescriptions due to beginning of the year deductible limits under their insurance plans.
Such deductible limits go into effect at the beginning of each calendar year under many insurance plans, creating added financial burden for patients.
Drugs used for asymptomatic conditions, including Vascepa tend to be the most impacted.
John Theroux: Drugs used for asymptomatic conditions, including Vasepa, tend to be the most impactful. As Mike will also discuss later in this call, our Visepa franchise in the United States was profitable in the first quarter of 2021 and, along with our strong balance sheet, continues to support our global expansion plan. We remain optimistic regarding the opportunity for U.S. Pacific growth in the future. There continue to be millions of at-risk patients who are candidates for the Cardioprotective Benefits of Vasepa. Awareness of SIPA remains low.
As Mike will also discuss later in this call are Vascepa franchise in the United States was profitable in the first quarter of 2021, and along with our strong balance sheet continues to support our global expansion plans.
We remain optimistic regarding the opportunity for us to see both growth in the future.
There continues to be millions of at risk patients who are candidates for the cardio protective benefits of Vascepa.
Awareness of Vascepa remains low.
This low awareness is evident both in our opinion surveys and by broad use of competing products that have failed outcome studies.
John Theroux: This low awareness is evident both in opinion surveys and by the broad use of competing products that have failed outcomes. However, the data supporting the effectiveness of the SEPA is compelling. The compelling nature of this data is reflected both by regulatory approvals for the drug by the U.S. FDA, Health Canada, and now the European Commission and the U.K. regulatory body. The importance of this data is widely published in peer-reviewed journals, and 15 medical societies globally now recommend use of icosaminethyl for cardiovascular risk reduction.
The data supporting the effectiveness of Vascepa is compelling.
The compelling nature of this data is reflected both by regulatory approvals for the drug by the U S. FDA Health, Canada, and now the European Commission and the U K regulatory body.
The importance of this data is broadly published in peer reviewed journals.
And 15 medical societies globally now recommend use of Iqos have been apple for cardiovascular risk reduction.
While key opinion leaders and medical societies, no vascepa as effectiveness, most health care professionals and at risk patients remain unaware of the drug or lack details.
John Theroux: While key opinion leaders and medical societies know of Zika's effectiveness, most healthcare professionals and at-risk patients remain unaware of the drug or lack details. As a result, for example, approximately 2 million people take phenofibrates despite the fact that these products have failed outcome studies and have various side effects. And FDA revoked the indication for these products with regard to cardiovascular risk reduction in combination with a statin, as the benefit does not outweigh the risk.
As a result for example, approximately 2 million people take phenyl five rates. Despite the fact that these products have failed outcome studies.
Various side effects.
And F D. A revoked the indications for these products with regard to cardiovascular risk reduction in combination with a statin as the benefit does not outweigh the risk.
John Theroux: Yet, still today, roughly three times as many patients take phenofibrate with their failed outcome study than take the SIPA with this proven effective result. And for persistent cardiovascular risk, there are even more people taking other products such as dietary supplements such as fish oil preparations despite their failed results in lowering cardiovascular risk beyond statin therapy.
Yet still today roughly three times as many patients take five range with their failed outcome study then take vascepa with its proven effective results.
And for persistent cardiovascular risk there are even more people taking other products such as dietary supplement fish oil preparations despite their failed results and lowering cardiovascular risk beyond statin therapy.
John Theroux: Clearly, there is a significant opportunity to educate physicians and patients about the merits of VASIPA as opposed to failed and unproven products. More can be done to benefit patients with proven, approved therapy. As you know, we launched Visepa for the treatment of persistent cardiovascular risk shortly over a year ago. But, as with other branded ADRs, during most of that timeframe, our commercial efforts have been slowed by COVID-19, as healthcare professionals and patients were focused on preventing and treating COVID-19 versus preventative care for other medical concerns.
Clearly there is significant opportunity to educate physicians and patients about the merits of vascepa as opposed to failed an unproven products.
More can be done to benefit patients with proven approved therapy.
As you know, we launched vascepa for the treatment of persistent cardiovascular risk shortly over a year ago.
But as with other branded agents.
During most of that time frame, our commercial efforts have been slowed by COVID-19.
As health care professionals and patients were focused on preventing and treating COVID-19.
Vs preventative care for other medical concerns.
John Theroux: Public reports from IQVIA showed patient visits to doctors, on average, during the first quarter of 2021 were down to approximately 78% of pre-COVID levels experienced during the first quarter of 2020. The decline in patient visits was most significant in various geographies in the United States where, prior to the pandemic, SEPA volumes and growth were the most robust.
Public reports from my queue via showed patient visits doctors on average during the first quarter of 2021 were down to approximately 78% of pre COVID-19 levels experienced during the first quarter of 2020.
The decline in patient visits was most significant in various geographies in the United States, where prior to the pandemic vascepa volumes and growth were the most robust.
While the effects of COVID-19, where a significant part of our decision to pull back on Vascepa promotional efforts in the first quarter of 2021 that pullback is expected to be temporary.
John Theroux: While the effects of COVID-19 were a significant part of our decision to pull back and halt promotional efforts in the first quarter of 2021, that pullback is expected to be temporary, as vaccinations take hold in the United States, and the effects of COVID-19 are received. We expect to enhance our promotional efforts in the U.S. with branded and unbranded educational efforts that include digital and non-personal channels, as well as peer-to-peer initiatives, such as promotional medical education programs and product theaters, that further increase Visepa brand awareness and clarify Visepa's unique clinical profile.
As vaccinations take hold in the United States and the effects of COVID-19 recede.
We expect to enhance our promotional efforts in the U S with branded and unbranded educational efforts that include digital and non personal channels as well as peer to peer initiatives such as promotional medical educational programs and product theaters that further increase the <unk>.
Super brand awareness and clarify Vascepa has unique clinical profile.
Some of our non branded initiatives, such as podcasts and satellite media tour with key opinion leaders.
John Theroux: Some of our non-branded initiatives, such as podcasts and satellite media tours with key opinion leaders, will highlight the need for at-risk patients to get back to their doctors' offices and to promote testing for cardiovascular risk. As mentioned in today's press release, we see some early signs of the effects of COVID-19 potentially receding.
We will highlight the need for at risk patients to get back to their doctor's offices and to promote testing for cardiovascular risk.
As mentioned in today's press release, we see some early signs of the effects of COVID-19 potentially receding.
For example.
John Theroux: While only roughly half of the positions we target are now open to office visits from sales representatives, that level is roughly 8% higher now than it was roughly six months ago. We recognize that trying to grow a brand in the face of generic competition is atypical. However, the generic launch with a skinny label and limited supply is atypical, based on what is known to us currently. Assuming that the effects of COVID-19 recede, facilitating market growth, we remain convinced that there is greater value to shareholders and, undoubtedly, to patient care for us to continue to work to increase education, grow market penetration, and seek to grow usage of branded FISIPA faster than generic competition.
Why only roughly half of the physicians we target are now open to office visits from sales Representatives.
That level is roughly 8% higher now than it was roughly six months ago.
We recognize that trying to grow a brand in the face of generic competition is atypical.
However, the generic launch with a skinny label and limited supply is atypical.
Based on what is known to us currently.
Assuming that the effects of COVID-19, recede facilitating market growth, we remain convinced that there is greater value to shareholders and undoubtedly the patient care.
For us to continue to work to increase education grow market penetration and seek to grow usage of random vascepa faster than generic competition.
We understand generic companies and their suppliers have not made the investments in capacity expansion that amarin has made.
John Theroux: We understand generic companies and their suppliers have not made the investment in capacity expansion that Amarin has made. Currently, there is only one generic in the market, and there have been reports of inconsistent levels of supply in different areas of the United States and periodic stock outages for that product, creating week-to-week fluctuations in the level of prescriptions filled by retail pharmacies with the generic product. These fluctuations in generic product availability impact the level of Visepa-branded prescriptions filled, although capacity for generic competition may increase over time. Based upon information available to us currently, we anticipate that capacity through their current suppliers will remain a fraction of the capacity of Amarin suppliers.
Currently there is only one launch generic in the market.
And there have been reports of inconsistent levels of supply in different areas of the United States and periodic stock outages for that product, creating week to week fluctuations in the level of prescriptions filled by retail pharmacies with the generic product.
These fluctuations in the generic product availability impact the level of Vascepa branded prescriptions filled.
While capacity for generic competition may increase over time.
Based upon the information available to us currently.
We anticipate that capacity through their current suppliers will remain a fraction of the capacity of amarin suppliers.
John Theroux: We continue to hear complaints from patients who have found the generic drug more expensive than branded placebos, and various managed care companies have witnessed that the generic product, on a net price basis, is more expensive to them than branded Visepa. However, since the generic product has been launched, overall managed care coverage for branded Visepa has continued to improve. In Q1 2021, based upon data from Symphony Health, total prescriptions by Cosaben Ethyl, consisting of branded and unbranded products, increased by approximately 11% over Q1 2020.
We continue to hear complaints from patients who have found the generic drug more expensive than branded vascepa.
And various managed care companies have witness that the generic product on a net price basis is more expensive to them than branded vascepa.
Since the generic product has been launched overall managed care coverage for branded Vascepa has continued to improve.
Okay.
In Q1, 2021 based upon data from Symphony Health total prescriptions by coastal bend ethyl consisting of branded and unbranded product increased by approximately 11% over Q1 2020.
Of these reported prescription estimates approximately 9% were for the generic version of Iqos spend at all.
John Theroux: Of these reported prescription estimates, approximately 9% were for the generic version of icosafent ethyl. As discussed previously, Amarin filed a cardiovascular risk reduction patent infringement lawsuit against the generic manufacturer and a health care insurance company based upon a collection of activities by them that we believe infringe our cardiovascular risk reduction patent, for the feedback. We have no update to provide today regarding that litigation.
As discussed previously.
<unk> filed a cardiovascular risk reduction patent infringement lawsuit against the generic manufacturer and a health care insurance company based upon a collection of activities by them, which we believe infringe or cardiovascular risk reduction patents for vascepa.
We have no update to provide today regarding that litigation, we refer people to our court filings for more details.
John Theroux: We refer people to our court filings for more details. Now, to progress with our Global Expansion Plan, it is my pleasure to turn the call over to Kareem.
Turning now to progress with our global expansion plans.
It's my pleasure to turn the call over to Karim.
For those of you who don't know cream.
John Theroux: For those of you who don't know CREAM, he is a global commercial leader with considerable experience successfully launching cardiovascular drugs in Europe and around the world. Kareem was with Merck for 22 years, where he served in leading commercial roles in seven countries across three continents, and where he led Merck's multi-billion dollar Lipid franchise, among other leadership roles. The board and I have every confidence that Kareem is the right leader at the right time, and we are working closely to facilitate a smooth transition over the coming months.
He is a global commercial leader with considerable experience successfully launching cardiovascular drugs in Europe.
And around the world.
Graeme was with Merck for 22 years, where he served in leading commercial roles in seven countries.
Across three continents, and where he led merck's multi billion dollar lipid franchise among other leadership roles.
The board and I have every confidence that cream is the right leader at the right time, and we're working closely to facilitate a smooth transition over the coming months.
As a reminder, he has a track record of helping grow business lines in the United States Europe, and then the rest of the world here.
John Theroux: As a reminder, he has a track record of helping grow business lines in the United States, Europe, and the rest of the world. He joined Amarin in the middle of last year to be the head of our European commercial launch effort. He joined us on the heels of an extensive process in which we evaluated whether it was best for Amarin shareholders for us to self-launch Vizcapa in Europe or to license such an opportunity to another company. As expressed at that time, the process concluded that the greatest value was for Amarin to retain such rights and self-lawn.
He joined the Amarin in the middle of last year to be the head of our European commercial launch efforts.
He joined US on the heels of an extensive process in which we evaluated whether it was best for amarin shareholders for us to self launch the sketchup in Europe or to license such opportunity to another company.
As expressed at that time the process concluded that the greatest value was for amarin to retain such rights and self launch.
Most investors with whom I have spoken support that decision.
John Theroux: Most investors with whom I have spoken support that decision. While I and others at Amarin were impressed with Karim before he joined us, his work at Amarin has demonstrated that he is capable of much more. He has proven that he can work in Amarin's fast-paced environment.
While I and others in Amarin were impressed with clean before I joined US. His work at Amarin has demonstrated that it is capable of much more.
He has proven that he can work in amarin is fast paced environment.
John Theroux: He has developed a passion for our products, and he has recruited an outstanding team of people. And he has led an effort in a very short period of time that positions us well for market access negotiations. He has helped expand Amarin's relationships in Europe. He has built good working relationships with all functions of Amarin, and he has established thoughtful plans for Amarin in Europe while increasingly contributing to other aspects of Amarin's business. As you get to know him, I am sure that you will be impressed with him as well.
He developed a passion for our product he has recruited an outstanding team of people.
And he has led an effort.
Very short period of time, which positions us well for market access negotiations.
He has helped to expand amarin relationships in Europe. He.
He has built good working relationships with all functions of Amarin.
And he has established thoughtful plans for amarin in Europe, while increasingly contributing to other aspects of amarin business.
As you get to know him I'm sure that you'll be impressed with him as well.
Kareem Mikhail: He is in the process of recruiting a new head for Europe, and until that is complete, he will continue to fill that role while getting ready for the CEO transition scheduled for August. With that, let me turn the call to Karim to discuss our international plan. Thank you for those kind words, John, and good morning, everyone.
He is in the process of recruiting a new head for Europe and.
Until that is complete he will continue to fill that role while getting ready for the CEO transition scheduled for August.
With that let me turn the call to cream to discuss our international plans.
Thank you for those kind words, John and good morning, everyone before I update on evidence progress in Europe. Please know that I'm excited about amarin opportunities in the United States Europe and throughout the World before John and the Board asked me to become CEO, the opportunity for which I am humbled optimistic and excited.
Kareem Mikhail: Before I update on Amarin's progress in Europe, please know that I'm excited about Amarin opportunities in the United States, Europe, and throughout the world. Before John and the board asked me to become CEO, the opportunity for which I am humbled, optimistic, and excited, I was thrilled by the progress we had been making in preparing to launch Vasqueta in Europe. Amarin's R&D team, medical affairs team, and supply team, including quality and CMC, are amazing. The label we received for Basquepa in Europe is broad, clear, and concise.
I was thrilled by the progress we have been making in preparing for loans, if I skip in Europe.
<unk> R&D team medical affairs team and supply team, including quality and CMC are amazing the label, we received proof of skipper and Europe is broad clear and articulate.
Kareem Mikhail: With this label, which is very representative of our reduced patient population, we should be able to help many patients. In my comments today, I intend to focus on our commercialization plans, particularly in Europe, where our commercial success is a high priority for the immediate future. There are multiple potential product opportunities which our R&D and medical teams are evaluating. As more progress is made regarding those potential opportunities, and as I get further involved in these areas, I will circle back in the future with further comments.
With this label, which is very representative of our reduces patient population, we should be able to help many patients in my comments today I intend to focus on our commercialization plans, particularly in Europe, where our commercial success is a high priority for the immediate future there are.
Multiple potential product opportunities, which our R&D and medical teams are evaluating.
As more progress is made regarding those potential opportunities and as I get further involved in these areas. We will circle back into the future with further comments I have no doubt that the amarin team can handle more than one product regardless of the large size of the opportunities for vascepa in different markets.
Kareem Mikhail: I have no doubt that the Amarin team can handle more than one product, regardless of the large size of the opportunities for Vesipa in different markets. Regarding Europe, it is rare to be launching a new drug that is already out, which has no proven competitive therapy and for which the consequences of not taking the therapy include unnecessarily high risks of stroke, heart attacks, and cardiovascular disease. However, cardiovascular disease is often as symptomatic.
Regarding Europe. It is rare to be launching a new drug which is already has outcomes, which has no proven competitive therapy and for which the consequences of not taking the therapy include unnecessarily high risks of stroke heart attacks and cardiovascular death. However.
Yeah.
Cardiovascular diseases often asymptomatic.
And even with the good clinical results and day recommendations of leading medical societies change can be slow and of course, no drug will be prescribed booz Allen to thoughtful and intense educational and commercialization plan. The two most significant challenges before us are market access and product to Williams.
Kareem Mikhail: And even with good clinical results and the recommendations of leading medical societies, change can be slow. And, of course, no drug will be prescribed without thoughtful and intense education and commercialization. The two most significant challenges before us are market access and product awareness. We believe our growing team of highly seasoned European pharmaceutical executives, most of whom have years of experience working with big pharmaceutical companies in Europe, are very much prepared to meet these challenges head-on and side-by-side with the deeply experienced existing Americans. Market access, which involves establishing approved pricing, is the key to the success of any drug in Europe. It must be realized on a country-by-country basis, unlike in the United States, where there are many payers.
We believe our growing team of highly seasoned European pharmaceutical executives, most of whom have years of experience working with big pharmaceutical companies in Europe are very much prepared to meet these challenges head on and side by side with the deeply experienced existing amarin.
Market access, which involves establishing approved pricing is the key to success of any drug in Europe. It must be realized on a country by country basis. Unlike in the United States, where there are many payers for the most part in Europe. Each country has a single payer government run.
Kareem Mikhail: For the most part, in Europe, each country has a single payer, government-run healthcare system. In most countries of Europe, a drug cannot be launched successfully until a price is proposed and negotiated. The process of getting market access varies by country and can be time-consuming. The degree to which this market access process is visible varies from country to country, both while trying to gain market access and after market access is secured. Because these will be ongoing negotiations, and because it is generally counterproductive to engage in public negotiations, there may be limited information available to you along the way. Many of you will have experienced watching and waiting for other companies to progress confidentially through such negotiations with their drug.
Health care system in most countries of Europe, a drug cannot be launched successfully.
Pillar prices proposed negotiated and agreed.
The process is getting market access varies by country and can be time consuming.
The degree to which this market access process is visible varies from country by country growth, while trying to gain market axis and after market access is secured.
Because this will be ongoing negotiations and because it is generally counter productive to engage in public negotiations there may be limited information available to you along the way.
Many of you will have experienced watching and waiting for other companies to progress confidentially through such negotiations with their drugs.
Kareem Mikhail: We're on that same path. Because we are the first drug for our indication, we expect that we will get attention, but it's too early to predict the end timing of such negotiations. The process, while not externally visible on a daily basis, provides the right environment for a smooth and trustworthy negotiation with the authorities in Egypt.
We don't have that same path because we are the first drug for our indication we expect that we will get attention, but it's too early to predict the and timing of such negotiations.
The process, while not externally visible on daily basis provides the right environment for a smooth and trustworthy negotiation with the authorities in each country.
As information is disclosed from the market access processes in various countries. Please note that ultimately the net price that gets agreed in each country is what matters. The most.
Kareem Mikhail: As information is disclosed from the market access processes in various countries, please note that, ultimately, the net price that gets agreed in each country is what matters the most. List prices are introduced, but list prices are often not the final. As in the US, the WAC price differs from the net price. For example, in Germany, where a price can be declared and used for the first year, the price for the second year needs to be negotiated and will vary from the price used in the first. Also, different countries will end up having similar list prices but potentially slightly different net prices as each country has a different markup.
List prices get introduced but list prices are often at the final price as in the U S. The WAC price difference from the net price for example, in Germany, where the price can be declared and used for the first year the price for the second year it needs to be negotiated and will vary from there.
Price used in the first year.
Also different countries will end up having similar list prices, but potentially slightly different a net prices as each country has a different markups terms.
Throughout the past several months our team with the support of various adviser.
Kareem Mikhail: Throughout the past several months, our team, with the support of various advisors, has been diligently working to prepare reimbursement for. However, there were limitations to how much of this could be accomplished prior to marketing, authorization, and labor. We plan to file market access dossiers in 10 countries in the coming months, including in some of Europe's largest. These dossiers include 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 proposed prices.
Has been diligently working to prepare our reimbursement dossiers there were limitations to how much of this could be accomplished prior to marketing authorization and leaving.
We plan to file market access dossiers in 10 countries in the coming months, including in some of Europe's largest countries. These doses includes the data demonstrating the uniqueness of our skipper for a scientific perspective, various country specific demographic data sets to define the eligible patient.
Based on the label and proposed pricing.
Kareem Mikhail: Our pricing strategy for Vaskepa in Europe will be to pursue a value-based price. We believe that the reimbursed price we are seeking is well justified based on the demonstrated effectiveness of VASCEPA in reducing cardiovascular events, the high economic burden and the societal cost of heart attacks, strokes, and other cardiovascular events that VASCEPA can help avoid, as well as the reduction of pain and suffering for at-risk patients and their families.
Our pricing strategy from a skip in Europe will be to pursue a value based price.
We believe that the reimbursed price we are seeking is well justified based on the demonstrated effectiveness of our skipper and reducing cardiovascular events the high economic burden and the societal cost of heart attacks strokes and other cardiovascular events. The skipper can help avoid as well as debt.
Reduction of pain and suffering for at risk patients and their families.
After the first 10 countries submissions for market access we plan to pursue a second waves of reimbursement filings in other European countries.
Kareem Mikhail: After the first 10 countries' submissions for market access, we plan to pursue a second wave of reimbursement filings in other European countries. Regarding market awareness, despite the two leading cardiovascular medical societies in Europe recommending the use of icosapent as a treatment, overall awareness of VASCEPA in Europe is low, which is as expected.
Regarding market awareness, despite the two leading cardiovascular medical societies in Europe recommending use of Iclusig Desai.
Overall awareness of our skipper and Europe is low this is as expected. The skipper was only a month ago and prior to regulatory approval, we could not engage in any branded activities.
Kareem Mikhail: VASCEPA was only approved a month ago, and prior to regulatory approval, we could not engage in any branded, Because Germany is the largest market in Europe and because Germany allows market access for one year, based on a declared price rather than a negotiated one, much of our initial market access initiatives are starting by focusing on Germany. Our current plan Call for a build-out of our current staff in Europe to approximately 300 people by the end of 2021. Toward that end, we started training sales reps in Germany to advance pre-launch disease and brand awareness initiatives. And in May, we expect to deploy approximately 150 sales representatives.
Because Germany is the largest market in Europe, and because Germany allows market access for one year based on a day clearing price rather than a negotiated one much of our initial market access initiatives.
Alright thing by focusing on Germany.
Our current plan.
<unk> for the build out of our current staff in Europe to approximately 300 people by the end of 2021 toward that end, we started training sales reps in Germany to advance prelaunch disease and brand awareness initiatives and in May we expect to deploy approximately 150 sales.
Representative.
The combined with various other initiatives, including various digital initiatives will emphasize disease and product awareness.
Kareem Mikhail: They, combined with various other initiatives, including various digital initiatives, will emphasize disease and product awareness. It is common for new drugs in Europe to have a period during which awareness is promoted before the drug can launch. And in Germany, the one-year period with a declared price does not commence until the drug is launched.
It is common for new drugs in Europe had a period in which awareness is promoted before the drug can launch and in Germany. The one year period with the declared price does not commence until the drug is launched.
We aim to begin to sell the skipper and Germany before the end of Q3 this year.
Kareem Mikhail: We aim to begin to sell Vaskepa in Germany before the end of Q3 this year. Currently, the effects of COVID-19 are significant in Germany, and we are hoping that these effects will subside during the summer months, as the rollout of vaccinations in Germany becomes more widespread.
Currently the effects of COVID-19 are significant in Germany. We are hoping that these effects will subside during the summer months.
The rollout of vaccinations in Germany become more widespread.
Our European market authorization was timely as it allowed for us to debut of our skipper at two premier cardiovascular medical meetings held virtually this month.
Kareem Mikhail: Our European market authorization was timely as it allowed for us to debut VASCEPA at two premier cardiovascular medical meetings held virtually this month. The European Society of Cardiology Prevention, or ESCP, and the German Society of Cardiology, or DGK. The combination of these two medical meetings created an ideal opportunity to amplify our messages before audiences of leading cardiologists in our target market, with compelling clinical data in support of the use of VASCEPA to reduce cardiovascular risk.
European Society of Cardiology prevention or ESC.
And the German society of Cardiology or D G gay.
Combination of these two medical meetings created an ideal opportunity to amplify our messages before audiences of leading cardiologist in our target markets with compelling clinical data in support of the use of vascepa to reduce cardiovascular risk.
We plan to continue to take advantage of these venues with the help and support of some of the world's leading cardiovascular key opinion leaders and we will do similarly in additional countries cardiovascular Congresses.
Kareem Mikhail: We plan to continue to take advantage of these venues with the help and support of some of the world's leading cardiovascular key opinion leaders and will do similarly in additional countries. I am confident that the clinical need for VASCEPA in Europe is great.
I am confident that the clinical need from a skip in Europe is large the.
Kareem Mikhail: The clinical data is impressive. I'm also quite confident in the team we have in place now in Europe, For example, the specialty sales force in Germany, which has 10 years of cardiometabolic launch experience. Together with the expertise that the Amarin team in the United States has, we are ideally suited to succeed with the tasks ahead. We are working rapidly and with confidence to prioritize market access and heighten awareness. 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.
The clinical data is impressive.
I'm also quite confident that the team we have in place now in Europe. For example, the specialty sales force in Germany, which has 10 years cardio metabolic launch experience.
Together with the expertise that the amarin team in the United States ads are ideally suited to succeed with the tasks ahead.
We are working rapidly and with confidence with prioritization of market access and heightening awareness.
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.
In addition to these advances preparing Europe for commercialization Amarin has also made progress in other areas around the world. During the first quarter. We are pleased to have the Canadian cardiovascular society and the Egyptian cardiovascular Society recommends iclusig.
Kareem Mikhail: In addition to these advances preparing Europe for commercialization, Amarin has also made progress in other areas around the world. During the first quarter, we are pleased to have the Canadian Cardiovascular Society and the Egyptian Cardiovascular Society recommend IQUSApent and their Medical Treatment Guidelines for Cardiovascular Risk Reduction. Now, 15 medical societies have recommended use of Eicosapent FDA for Cardiovascular Risk Reduction in At-Risk Patients.
In the medical treatment guidelines for cardiovascular risk reduction now 15 medical societies have recommended use of Iqos ethane essel for cardiovascular risk reduction in at risk patients.
Kareem Mikhail: In China, our partner Edding has made considerable progress. Last November, we shared the positive data from Edding's Phase III clinical study in China. In January, we were delighted to share that icosapent ethyl was added to the Chinese Society of Cardiology Treatment Guidelines. Earlier this month, regulatory authorities in China, the Chinese National Medical Products Administration, accepted Edding's new drug application for review of Vasipa, which is another milestone on the path to approval for Edding.
In China, our partner, adding has made considerable progress.
Last November we showed the positive data from adding phase III clinical study in China.
In January we were delighted to share that <unk> ethyl was added to the Chinese society of cardiology treatment guidelines.
Earlier this month regulatory authorities in China, the Chinese National Medical products administration.
Septic, adding new drug application for review of Vascepa, which is another milestone on the path to approval for adding.
Adding currently anticipates receiving approval of Vascepa in mainland China near the end of 2021, and also anticipates approval of Vascepa in Hong Kong near.
Kareem Mikhail: Edding currently anticipates receiving approval of a CBRN in Mainland China near the end of 2021 and also anticipates approval of a SIPA in Hong Kong near the end of 2020. With approximately 180.4 million hypertriglyceridemia patients in China in 2019, and a history of rapid and widespread statin therapy usage in China, there is a significant medical need and a meaningful market opportunity for Amarin. Regarding the rest of the world, as you know, we have commercial partners in Canada and the Middle East, and we expect further positive contributions from these partners, particularly after the effects of COVID-19. We will give greater priority to other international markets. After we progress further in Europe,
Near the end of 2021.
With approximately $184 million hyper triglycerides EMEA patients in China in 2019.
And a history of rapid and long statin therapy usage in China, there is a significant medical need and a meaningful market opportunity for amarin.
Regarding the rest of the World as you know we have commercial partners in Canada, and the Middle East and we expect further positive contributions from these partners, particularly after the effects of COVID-19 subsides.
We will give greater priority to other international markets. After we progress further in Europe.
Amarin has a history of focus and a history of overcoming great challenges.
Kareem Mikhail: Amarin has a history of focus and overcoming great challenges. Currently, our greatest priorities are growth in the United States, successful commercialization in Europe, and supporting product approval in China. For now, these are large opportunities which I agree with John that we must seize.
Currently our greatest priority is our growth in the United States successful commercialization in Europe, and supporting product approval in China for now these aren't large opportunities upon which I agree with John that we might see.
Kareem Mikhail: In the future, we will undoubtedly also focus on additional product development and diversity. Over the next few months, as I prepare to transition to the CEO position, I expect to spend a lot of my time listening, asking, and learning. I hope you will be generous with your constructive thoughts, insights, suggestions, and honest feedback.
In the future we will undoubtedly also focus on additional product development and diversification.
Over the next few months as I prepare to transition to the CEO position I expect to spend a lot of my time listening asking and learning.
Hope you will be generous with your constructive thoughts insights suggestions and honest feedback.
Kareem Mikhail: I remain impressed by what Amarin has accomplished, particularly as a small company. I look forward to continuing to work with the Amarin team to build upon our successes as we are, I believe, destined to become a much bigger company. We have a unique and effective product. We have highly capable people, and we have a culture that emphasizes rapid decision making with a focused can-do approach.
I remain impressed by what the Amarin has accomplished particularly as a small company.
Look forward to continuing to work with the amarin team to build upon our successes as we are I believe destined to become a much bigger company, we have a unique and effective product we have highly capable people and we have a culture, which emphasizes rapid decision, making with a focused can do approach.
With this team and this approach I am confident that we have considerable opportunity to expand further in the U S and similarly large opportunities to expand internationally.
Kareem Mikhail: With this team and this approach, I'm confident that we have a considerable opportunity to expand further in the US and similarly large opportunities to expand internationally. While I believe the opportunities in the US will always be an important foundation for Amarin, now is a transformative period for Amarin, with our European commercial launch and our broader global expansion plans well underway. I feel privileged to be inheriting such a strong and experienced commercial team in the U.S., headed by Aaron Berg, and we have started to build a similarly impressive team in Europe.
While I believe the opportunity in the U S will always be an important foundation for amarin.
<unk> is a transformative period for imminent with our European commercial launch in our broader global expansion plans well underway.
I feel privileged to be inheriting such a strong and experienced commercial team in the U S headed by Aaron Berg and we have started to build a similarly impressive team in Europe. This is an incredibly exciting time in amarin.
Kareem Mikhail: This is an incredibly exciting time at Amerin, and I'm energized by the opportunities ahead and confident that we will make valuable progress, particularly with the impact of COVID-19. There is nothing more important that we can do today than succeed in our commercial. Yes, we have opportunities to diversify, and yes, I see value in diversification. And I'm confident that our team can handle multiple problems.
Energized by the opportunities ahead, and confident that we will make valuable progress.
Particularly as the impact of COVID-19 receipts.
There is nothing more important that we can do today then succeed in our commercial plans.
Yes, we have opportunities to diversify and yes, IC value and diversification and I'm confident that our team can handle multiple products. However, first and foremost we must execute on the large opportunities we have with our current product.
Kareem Mikhail: However, first and foremost, we must execute on the large opportunities we have with our current products. Doing so will create further opportunities. As I get more involved with Amarin's operations beyond Europe, working with others at Amarin, I look forward to reviewing such diversification opportunities. For now, execution on commercial growth in the U.S., Europe, and globally remains our top priority. With that update and review, let me turn the call over to Mike Culp, our CFO, for more detailed discussions of our financials. Mike?
Doing so will create further opportunities.
As I get more involved with eminence operations beyond Europe, working with others that amarin I look forward to reviewing such diversification opportunities.
For now execution on commercial growth in the U S Europe and globally remains our top priority.
With that update and review, let me turn the call over to Mike Kalb, our CFO for a more detailed discussions of our financials Mike.
Mike Kalb: Thanks Karim. Net total revenue in the first quarter of 2021 was $142.2 million. This amount consisted of $140.8 million in net product revenue from the United States, half a million dollars in net product revenue from outside the United States, and $800,000 in licensing and royalty revenue.
Thanks, Karim net total revenue in the first quarter of 2021 was $142 $2 million.
It consisted of $148 million in net product revenue from the United States.
Half a million dollars in net product revenue from outside the United States and $800000 in licensing and royalty revenue.
The first quarter of 2021 was significantly impacted by COVID-19, and severe winter weather, especially in states like California, Texas, and New York, which are states that have significant vascepa Rx volumes.
Mike Kalb: The first quarter of 2021 was significantly impacted by COVID-19 and severe winter weather, especially in states like California, Texas, and New York, which are states that have significant Visepa RX values. In addition, in the first quarter of 2021, we lost approximately 9% of prescriptions to generic competition. And this 9% excludes the broader market disruption caused by generic competition. Moreover, as reported in conjunction with first quarter 2020 results, net product revenue in the first quarter of 2020 included $10.8 million from the timing of customer orders and related receipts, which effectively provided an added week of revenue shipment. This anomaly did not reoccur in the first quarter of 2021. Further contributing to the decrease was a decline in net product revenue due to timing of orders from outside of the United States.
In addition in the first quarter of 2021, we lost approximately 9% of prescriptions to generic competition and this 9% excludes the broader market disruption caused by generic competition.
Moreover, as reported in conjunction with first quarter 2020 results net product revenue in the first quarter of 2020 included $10 $8 million from the timing of customer orders and related receipts, which effectively provided in the added week of revenue shipments.
The Saddam him, but he did not reoccur in the first quarter of 2021.
Further contributing to the decrease was a decline in net product revenue due to timing of orders.
From outside of the United States, we recognize net product revenue of half a million dollars. During the three months ended March 31, 2021, as compared to $6 $7 million. During the three months ended March 31 2020.
Mike Kalb: We recognize net product revenue of half a million dollars during the three months ended March 31, 2021 as compared to $6.7 million during the three months ended March 31, 2020. The results in 2020 included an initial order to ensure the availability of adequate product supply for the launch of Visepa in Canada. FIPA promotion and use outside of the United States has also been limited by the impact of the COVID-19 pandemic. Amarin, like many other companies, had limited access to physicians and patients due to the ongoing headwinds from the COVID-19 pandemic. Therefore, we did not invest in the kinds of promotions and marketing efforts that we ordinarily would have to increase education and awareness of the SEPA.
The results from 2020 included initial order to ensure availability of adequate product supply for the launch of Vascepa in Canada.
The Super promotion and use outside of the United States has been has also been limited by the impact of the COVID-19 pandemic.
Amarin like many other companies had limited access to physicians and patients due to the ongoing headwinds from the COVID-19 pandemic.
Therefore, we did not invest in the kinds of promotions and marketing efforts that we ordinarily would have to increase the education and awareness of Vascepa.
Mike Kalb: As a result, operating expenses were reduced by $29 million, primarily as a result of lower sales and marketing expenditures incurred as the company worked to efficiently manage expenses in light of COVID-19-related limitations impacting physicians, patients, and the level of our promotion. Included in our operating spending is continued support for previously described studies of the SEPA for potential use in COVID-19 prevention and symptom mitigation. Those ongoing studies are blinded, and we have no new data regarding those studies to report at this time.
As a result operating expenses were reduced by $29 million, primarily as a result of lower sales and marketing expenditures incurred as the company worked to efficiently manage expenses in light of COVID-19 related limitations impacting physicians patients and the level of our promotions.
Included in our operating spending his continued support for previously described studies of Vascepa for potential use in COVID-19 prevention and symptom, but mitigation.
Mitigation.
Ongoing studies are blinded and we have no new data regarding those studies to report at this time.
Mike Kalb: Due to the uncertainties regarding the effects of the COVID-19 pandemic and potential levels of generic supply, we are not providing quantified 2021 revenue guidance at this time. As of March 31, 2021, Amarin reported aggregate cash and investments of $538.7 million, consisting of cash and cash equivalents of $291 million and liquid short-term and long-term investments of $223.7 million and $24 million, respectively. We reiterate that based on our current plans, we believe that our existing resources are sufficient for U.S. Fund Vizcapa's launch in Europe and to get us to cash flow positive on a consolidated basis. With that financial overview, I will now turn the call back to Jon for closing remarks. Jon?
Due to the uncertainties regarding the effects of the COVID-19, pandemic and potential levels of generic supply, we're not providing quantified 2021 revenue guidance at this time.
As of March 31, 2021, Amarin reported aggregate cash and investments of $538 $7 million, consisting of cash and cash equivalents of $291 million and liquid short term and long term investments.
$223 7 million and $24 million respectively.
We reiterate that based on our current plans, we believe that our existing resources are sufficient in the U S to fund Vascepa is launched in Europe and to get us to cash flow positive on a consolidated basis.
With that financial overview, I will now turn the call back to John for closing remarks, John.
Thanks, Mike.
John Theroux: Thanks, Mike. Over the past few years, I have frequently discussed our growth strategy, in which the next phases include Amarin expanding globally and further diversifying. I believe that Amarin has the product, people, plans, and resources to be successful. In many respects, 2021 is the year of execution for Amarin. Before year end, we anticipate commercial launch in Germany and approval in China. And as COVID-19 begins to recede in the United States, we look to reaccelerate the growth of SEPA usage, revenues, and profits.
Over the past few years I have frequently discussed our growth strategy.
And which the next phases include amarin, expanding globally and further diversifying.
I believe that Amarin has the product people plans and resources to be successful.
In many respects 2021 is a year of execution for amarin.
Before year end, we anticipate commercial launch in Germany and approval in China.
And as COVID-19 begins to recede in the United States.
We look to Reaccelerate the growth of Vascepa usage revenues and profits.
It has been and continues to be my privilege to serve as Stuart for your company over the past 12 years.
John Theroux: It has been and continues to be my privilege to serve as steward for your company over the past 12 years. I will continue to work full time until August 1st in support of Amarin's growth, and I am committed to providing help, if needed, beyond August 1st, as I prepare to pass the baton to Karim. I know that I leave Amarin and you, our loyal shareholders, in strong hands. I express this confidence both from my experience working with the Amarin team and also as a fellow shareholder, of which my equity in Amarin is my largest asset.
I will continue to work full time until August 1st in support of Amarin growth.
Committed to providing help if needed beyond August 1st.
As I prepare to pass the baton to Crane.
I know that I leave Amarin, and you our loyal shareholders and strong hands.
I expressed his confidence both from my experience.
Working with the Amarin team and also as a fellow shareholder of which my equity Amarin is my largest asset.
With that operator.
John Theroux: With that, operator, we are ready to open the call to questions. Thank you. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while you are 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 at this time. And the first question is coming from Yasmin Rahimi.
We are ready to open the call to questions.
Thank you ladies and gentlemen, the floor is now open for questions. If you have any questions or comments. Please press star one on your phone at this time.
We asked a lot of posing your question. Please pick up your handset if listening on speaker phone to provide optimum sound quality. Once again. Please press star one if you have any questions at this time.
And the first question is coming from Yasmin Rahimi from Piper Sandler Jasmin Your line is live.
Operator: Yasmin Rahimi from Piper Sandler. Yasmin, your line is live.
Yasmin Rahimi: Thanks, Jutine, for taking my questions, and it's been a privilege working with you, and you'll be greatly missed. The first question for you is, can you give us some color on the timeline on when you hope that all 10 dossiers will be completed and pricing negotiations will be completed? What is the timeframe or maybe the order of the countries that we could maybe expedite the process? That would be great, and thank you for taking my question.
Thanks for taking my question, it's been a privilege working with you John.
Greatly missed.
First question for you is just can you give us some color on the timeline on when you hope that all kind of see as would be complete and in pricing negotiations that would be completed what is the timeframe or maybe the order of the country that we could maybe expedite the process that would be great and thank you for taking my question.
John Theroux: Good morning, this is John. Thank you for the nice comments. With regard to timing in Europe, since I'm sitting next to Karim and others, and Karim's intimately involved with Europe, let me turn things over to him, and he can talk a little bit about the European process. In general, not just for us but for other countries, a bit more about our plans, and try to do so, we can answer your questions. Sure. Hi, good morning, Yasmeen.
Sure.
Good morning.
John Thank you for the nice comments.
With regard to timing in Europe since I'm sitting next to Graham and others.
Frames intimately involved with Europe.
Let me turn it back over to Andy can talk a little bit about that.
From a process and in general that this prospect abroad countries, but a bit more about our plans in price.
And the answer to your question sure Hi, Good morning, guys.
So as we shared before we have been working on getting those gains from 10 countries.
Kareem Mikhail: So, as we shared before, we have been working on 10 dossiers for 10 countries to submit over the next weeks and months. And obviously, we realize that this work has started, I would say, even before I joined, right, for us to be ready at this point in time. So, significant effort has been invested in that.
Over the next weeks and months and obviously you realize that this work has started.
I would say even before I joined it was right for us to be ready at this point in time some significant effort.
Net investment into that obviously the sequence.
Kareem Mikhail: Obviously, the sequence of the submission really depends very much on two elements. One, what is the requirement of the country? So each country has a different requirement, and certain files will end up being far more significant than others. I have seen in some of the retail questions that people are asking, what are in those dossiers? So there are three main components. The first one is really a summary of the scientific evidence that we have from the reduced study.
Of the of the submissions really depend very much on two elements.
What is the requirement of the country. So each country has a different requirement in certain files.
Far more significant than others.
I've seen in some of.
The retail questions that people are asking what are in those doses. So there are three main components.
The first one is really a summary of the scientific evidence that we have from the reduce it study.
Kareem Mikhail: The second part is really the eligible patient population in that country. And third, a proposed price along with a budget impact. So we're working very, very closely, you know, with our advisors in these countries to submit those first 10. Those first 10 will include the largest five countries in Europe. So they will be Germany, France, the UK, Spain, and Italy, right? So no question there.
Second part is really the eligible patient population in that country and third proposal pricing along with a budget impact. So we're working very very closely.
With our advisors in these countries to submit those first day. Those first day will include the large five countries in Europe.
And Germany, France U K, Spain, right. So no question there other than these countries it's really.
Kareem Mikhail: Other than these countries, it's really a question of their own timelines. And for us, the fastest we will be able to submit, we will definitely be doing that. Ray, maybe just as a follow-on there, because it's probably on people's minds, you know, so why launch in Germany, not now, but later this year? And why aren't we launching in every country this year? So first of all, Germany is very unique because it allows access very early on.
Treating a question there.
Their own timeline and for US. The fact that we wouldn't be able to submit we will definitely be doing that.
Great maybe just as a follow on there because probably on People's minds. So wildlife.
Germany, not now but.
I know this year and why are we launching in every country is here. So so first of all Germany is very unique because it allows access very early on.
Kareem Mikhail: And you know, in reality, we will not be able to access any other country until we negotiate the price in full. However, in Germany, we can declare a price and start promotion. The reason why we decided to wait for a number of months before MQ3 as the launch date we declared is number one, as you know, we have not had the chance to promote the brand until very recently. We did not get approval except a month ago.
In reality, we will not be able to access.
Country unveiling, we negotiate the price impulse.
However, in Germany, we can declare a price and stock promotion.
And why we decided to wait for a number of months before the end to free as.
The loans.
Larry.
Number one as you know we have not had the channel to promote the brand.
Very recently, we did not get approval, except a month ago, So I'm kind of leaning away from.
Kareem Mikhail: So currently, the awareness rates for Vaskepa are definitely low, and that's no surprise there. So if we rush to launch, we put the product on the market, and we actually lose some of the opportunity of the one year of free declared pricing because, for the moment, access to physicians is very limited also because of COVID. If you look at, Germany is currently missing a second peak today; they are 80% of their highest peak, so we're also conscious that we will need a bit more time to ensure that we engage with prescribers in Germany before we are ready for a launch.
In this range for basketball are definitely low.
Prior you there.
If we rush launch.
The product from the market then we actually do.
The opportunity of the one year of free price.
Pricing because for the moment the exit from physicians is very limited and also because of COVID-19.
If you look at.
Germany is currently existing.
Today, they are 80% of the highest peak so we're also conscious.
We will need a bit more time to ensure that we engage with prescribers in Germany before we are ready for a launch.
Thanks Brent.
Kareem Mikhail: Thank you. And the next question is coming from Louise Chen from Cantor. Louise, your line is live.
Thank you.
Thank you and the next question is coming from Louise Chen from Cantor Louise Your line is nice.
Operator: Hi, thanks for taking my questions here. And John, I will echo Yasmeen's thought, we are going to miss you greatly and really enjoyed working with you through all these years. So the first question I had for you is, what type of candidate are you looking for in a new head of the EU? You know, what kind of people have you been speaking to?
Hi, Thanks for taking my questions here and John I will echo, yes means that we aren't going to Miss you greatly and really enjoyed working with you through all these years. So first question I had for you is what type of candidate are you looking for in a new head of the E U.
What kind of person people or have you been speaking to and then secondly can you give more color on your thoughts on how do you expand your product portfolio beyond Vascepa and that Schipa are you looking at a proof products R&D type of opportunities and the timing behind this and then maybe one last question here just that people have asked US a lot of how do you think about.
Louise Alesandra Chen: And then secondly, can you give more color on your thoughts on how you will expand your product portfolio beyond VASIPA and VASKIPA? Are you looking at approved products, R&D type opportunities, and the timing behind this? And then maybe one last question here, just that people have asked us a lot, is how do you think about generic competition in 2021 and beyond as it pertains to additional entry into the market, supply, and anything else we're thinking about? Thank you.
Generic competition in 'twenty, 'twenty, one and beyond as it pertains to additional entrance into market supply and anything else. We're thinking about thank you.
John Theroux: Louise, thanks for the comments. Let me try and take them in reverse order, and I'll have Amarin talk about the European head and then any other comments he wants on the other matters. So with respect to generic competition, you know, we have one generic in the marketplace today. They have, by their own accounts, a limited supply. We have both patients and payers commenting that, you know, they're regularly finding the branded product to be less expensive than the generic product, and they're regularly finding shortages or stockouts for the generic product. As we've described in the past, this is a very atypical generic launch. Vizipa was just launched last year for its primary indication, so awareness is relatively low.
Louise.
For the call.
Comments.
Let me, let me try to take them in.
In reverse order.
Talk about the European patent.
And then any other comments you want but on the other matters so with respect to generic competition.
We have one generic in the marketplace today.
They have.
Accounts have limited supply, we have both patients and payers, commenting that regularly finding the branded products to be less expensive than a generic product and they regularly finding.
The shortages are stock outs for the generic product.
As we've described in the past.
Free atypical generic launch of Vascepa was just launched last year for its primary.
Patient awareness is relatively low.
John Theroux: We see the market opportunity in the United States for Vizipa to be quite large, but it needs increased awareness. The COVID phenomenon has slowed that down, but I think we are making progress there. Certainly, managed care coverage in the United States overall has continued to improve. But with access, you know, being relatively low, as in our comments, we mentioned that, you know, we're now up to about 50% of our target physicians allowing access to us or to other sales representatives. That's great!
See the market opportunity in the United States for Vascepa to be quite.
Quite large that needs increases in.
Awareness COVID-19 phenomena has slowed that down and we are making progress there certainly that managed care coverage in the United States.
Overall has continued to improve but.
Access being relatively low our comments, we mentioned that we're now up to about 50% of our target physicians, allowing access to all sorts of other sales representative and Thats great.
John Theroux: It's, you know, not 100%, but it's a bit better than it was, say, you know, about 8% better than it was, you know, six months ago, for example. But, moreover, patients aren't yet coming back at their levels, and lab tests aren't being done yet. So the biggest thing that can happen for growth in the United States relative to the market overall is for COVID to recede through vaccinations and these high-risk patients to, you know, come back.
Non 100%.
But.
Other than it was say.
But he presented better than it was six months ago for example, but Moreover patients arent.
Yes, coming back at the levels and lab, just arent being John yet so the biggest thing that can happen for growth in the United States relative to the market overall is for COVID-19 received through vaccinations in these high risk patients too.
Come back in with that is our best that we can grow the market and grow the market in a way that.
John Theroux: And with that, it's our bet that, you know, we can grow the market and grow the market in a way that is faster than what, you know, generics can supply the market. You know, there are two other standards that were approved in the United States, but neither of those have been launched.
It was faster than what the generics.
Eric.
Supply in the market you know there are two other standards that were approved in United States either of those.
Launch.
It's possible that a.
John Theroux: You know, it's possible that the generic that's in the market because of their comments may have additional supply at some point in the future. I would remind people that, you know, the indication for which that product is labeled is a skinny label. You know, it's our original indication for treating patients with very high triglycerides, traits greater than or equal to 500 mg per deciliter. Based upon reports we talked about earlier, that's about 7% of our scripts. But in the most recent quarter, based upon third-party data, it seems like they're selling beyond that 7%, about 9%.
The generic thats in the market.
Their comments may have additional supply at some point in the future.
Find people.
The indications for which that product is labeled skinny label.
Our original indication for treating patients with very high triglycerides trades greater than or equal to buy when it makes the deciliter.
Based upon reported profit earlier, that's about 7% of our scripts.
And the most recent quarter based upon third party data it seems like they are selling beyond that 7% about 99% and of course, we have litigation going on.
John Theroux: And of course, we have, you know, litigation going on that is an attempt to ensure that they stay within their labels. So it's a dynamic area. It's still sort of early in this regard, but, you know, with the effectiveness of Visepa, you know, with our strong team in the field and in the office doing promotion, provided COVID recedes, I think we can, you know, get back to, you know, re-accelerated growth. Mike Cobb had mentioned we pull back on promotional spending in the first quarter.
Attempt to ensure that they stay within their label. So it's a dynamic area.
It is still early in this regard, but with the effectiveness of Vascepa with our strong team in the field.
And the answer is doing promotion.
COVID-19 received I think we can get back.
Accelerated growth.
Cabot mentioned, we pulled back on promotional spending up in the first quarter begin to see some signs.
John Theroux: We begin to see some signs and see a little bit of early signs here, more new to brand, increased physician access, et cetera, that COVID may be easing. We'll start, you know, resuming some of our commercial spending in the United States, probably, you know, sort of incrementally initially, but really want to get back to that launch plan. With regard to diversification, and I think Kareem sort of covered this a bit in his comments, but there's nothing we can do right now that's more important than being successful with our commercial launch.
A little bit early signs here or new to brand.
Physician access et cetera.
COVID-19, maybe easing will start.
I'll start.
Resuming some of our commercial spending in the United States.
Probably sort of incrementally initially, but really want to get back to that launch plan.
With.
Guard to diversification I think Chris sorry.
Covered this a bit in his comments, there's nothing we can do right now is more important than being successful with our commercial launch so that being said, we've got our field team in the United States that has good relationships.
John Theroux: You know, that being said, we've got a field team in the United States that has good relationships with healthcare professionals and is doing, you know, very scientifically-based self-selling. We're developing the same thing for Europe. We've got a strong R&D team. We've got companies coming to us regularly asking us if they want us to co-promote their products or, you know, in-license their products. It's something that we look at regularly.
With health care professionals and doing it very scientific base.
We're developing the same thing or.
Europe had a strong R&D channel we've had companies come and goes regularly asking us if they wanted to co promote their products or in license. Their products is something that we look at regularly and the strategy of the company. It was always let's start with the niche market expands their cardiovascular risk reduction.
John Theroux: And then the strategy of this company was always, you know, let's start with a niche market, expand from there, get cardiovascular, risk reduction. The next stage was to go international, and then the fourth stage was diversification. And I am sure that, you know, particularly with the approvals now behind us in the U.S., Canada... And Europe, while the R&D team is still providing considerable support for market access for China, etc., more and more attention is going to be spent on what additional R&D might be done.
Next David will go internationally in the third.
The first stage was diversification.
I am sure that particularly with the approvals.
<unk> now behind Us and the U S.
<unk>, Canada.
In Europe, while the R&D team is still providing considerable support for market access.
For China et cetera.
More and more of the attention is going to be spent on what additional R&D.
Might be done with it.
John Theroux: With regard to a European head to free up Karim, with the launch of New York, I'm sure Karim is going to be very close to it. He's got a great team of people that he's already hired, but Karim, if you want to comment on that,
Guard to our European head to free.
Free on Crane.
The launch near and short range through very close to it and we've got a great team of people who've already hired but agreement do you want to comment on that sure and again, obviously as the launch and so important for amarin.
Kareem Mikhail: Sure. And again, obviously, as the launch is so important for Amarin, hence the importance of selecting the right leader for the organization, and, you know, the people we're already interacting with, because we did start the process, basically have three main criteria. The first one is the significant Karzum metabolic launch experience. This is a unique market, and if you haven't operated in it, it will take time for that person to basically, you know, build space and speed. So experience with Karzum's metabolic launch is very critical.
Fourth in selecting the right leader for the organization and.
The people were already interacting with it because we didn't start the process basically.
Three 3 million.
The first one is a significant government.
The launch experience. This is a unique market and if you have an operator.
For that person to basically.
They build space.
So it's big and so it's Gotta go metabolic launches getting critical the second one is obviously.
Kareem Mikhail: The second one is obviously operational P&L experience in Europe and beyond will be critical to ensure that we, you know, we drive the results. And finally, and I would say more importantly, is the attitude. You know, the drive for results. You know, the fact that we are going at a pace very close to, you know, German speed on the Autobahn, so there is no speed limit, basically, you know, we're trying to go as fast as we can.
So P&L experience in Europe and beyond.
Gotta be critical to ensure that we went.
We drive the adult and finally I would say more importantly is the average.
The drive for results.
The fact that we are at.
At the pace.
Very close to German speed on the Alco bond, so low speed limit.
You know what I'm trying to go as fast as we can from many companies actually takes more than two to three years.
Kareem Mikhail: You know, for many companies, it actually takes more than two to three years to establish themselves in Europe, where, up to now, we are actually less than 12 months from our August announcement, and we already have a German subsidiary with 150 people. So we look forward to identifying very soon the leader who will take my place and continue the successful launch in Europe. Thanks, Louise, for those questions.
Stablish themselves in Europe, where up to now we are actually less than 12 months.
From our August announcement, and we already have the German subsidiary with 150 people. So we look forward to identify very soon the leader who will pay.
My place in.
Continuing with the successful launch in Europe.
Thanks for those questions.
John Theroux: Before we take additional questions, operator, we've had a number of retail investors who have sent in some questions, and I wanted to, we won't get through them all, but I wanted to at least take the first couple on the list. The first one is with regard to the digital strategy in Europe. There was a reference to the Writers European Healthcare Conference last week where Karim was talking about the importance of digital strategy. Karim, maybe you could talk a little bit about what digital strategy is and why it's important and maybe how it's different than where this industry was even a short while ago.
Before we take into somebody's operator.
A number of retail investors, who have sent in some questions.
We won't get through them, all but I wanted to at least take the first couple on the list.
First one.
With regard to digital strategy in Europe.
There is reference John.
The writers European Healthcare conference last week.
Graeme was talking about.
Importance of digital strategy free maybe you could talk a little bit about what digital strategy is and why it's why it's important and maybe how it's different than what.
Whereas interest requests.
On a short while ago sure. So as you know from many years face to face interaction whether through field force or even in Congress. It was really the standard for many years, but over the last decade I Wouldnt say there has been a very significant shift.
John Theroux: Sure, so as you know, for many years, face-to-face interaction, whether through field force or even in congresses, was really the standard for many years. But over the last decade, I would say, there has been a very significant shift in the sources of information and education that prescribers and different stakeholders have had. And it's moving really from a face-to-face to more of a virtual engagement. So as Amarin is establishing itself in Europe, we want to make sure that we take advantage of that shift in the market and, in fact, hopefully lead it.
The sources of information and education that prescribers and different stakeholders.
Reading from a face to face to more virtual engagement.
Amarin has established itself in Europe, we want to make sure that we take advantage of that shift in market and in fact, hopefully lead it.
John Theroux: So we are building our launch strategy really depending on the market archetypes. There are European countries where you have what we call the blended model, meaning you still have a lot of traditional versus non-traditional ways of engaging with customers, while some markets, like the Nordics, you could actually engage fully digitally because these are countries where 90% of prescribers get their information really online. So in our digital strategy, we prioritize the channels by which we can engage with prescribers to ensure we have an effective and efficient model when we launch in Europe. Yeah, thanks Kramer.
So we are building our launch strategy really depending on the market occupy instead of all European countries, whether you will have what we call. The blended model, meaning you still have a lot of traditional versus nontraditional ways of engaging with our customers while some markets like the nordics you could actually engaged.
Digitally because these are countries, where 90% of prescribers getting their information online.
So how would a digital strategy, we prioritized the channels by which we can engage with the prescribers to ensure we have an effective and efficient model as we are launching in Europe. Thanks.
Kareem Mikhail: I know on your team you've got people who have a lot of experience in this both in the pharmaceutical field but also with consumer products as well. A second question, just before we go back to the ones online, was about the rest of the world. What's the strategy in other markets like Latin America, Mexico, Africa, India, and Russia? Those are big market opportunities. As we've stated, it's important for us to get further along in Europe and gain market access there before we get on to those and other potential countries globally.
Great.
We've got people who are about to experience.
Pharmaceutical field, but also where the consumer product as well a second question just before we go back to the online was about rest of the world. What's the strategy in other markets like Latin America, Mexico Africa.
India and Russia.
Yeah, those are big market opportunities.
As we've stated it is important for us to get further along in Europe.
Net market access there before we get onto those those and other potential.
Countries globally, but cardiovascular risk is a global phenomenon, we do care, but there is strategically a sequence to that.
Kareem Mikhail: But cardiovascular risk is a global phenomenon. We do care, but there is a strategic sequence to that, and we are doing planning and thinking there, but we want to get the European piece done before we get into those others.
We are doing planning and thinking there, but don't want to go.
The Europe piece, John before we get into.
Those other Soc.
Let me go back to the operator for whoever else by getting too for the next question.
John Theroux: So let me go back to the operator for whoever else might be in queue for the next question. Sure. The next question is coming from Michael Yee from Jefferies. Michael, your line is live. Uh, hey, thanks. Good morning. Uh, and, uh, appreciate it.
Certainly at the <unk>.
Next question is coming from.
Michael Yee from Jefferies, Michael Your line of sight.
Oh, Hey, thanks, good morning.
And I appreciate all the work John Yes, we will definitely Miss you.
Operator: Appreciate all the work, John. Yes, we will definitely miss you. And I appreciate the retail questions in front of me, but my question actually is around European pricing Cream, could you maybe just comment on how to think about the bookends of pricing? For Vespa, I know there are a lot of different prices for PCSK9 around Europe, and there's a big price delta from the US. Maybe you could just comment about how to think about, from a modeling perspective, the pricing in Europe and the parameters for that versus US pricing. Thank you, Thank you.
And I appreciate the retail questions and final from me, but my question actually is around our European pricing a cream could you maybe just comment around how to think about the bookends of pricing.
For Scott.
I know, there's a lot of different pricing for patients canine around Europe, and there's a big price Delta from the U S.
You could just comment about how to think about from modeling perspective from the pricing in Europe and.
Parameters for that first is U S pricing. Thank you.
Thanks, John.
Kareem Mikhail: Thank you. So actually you're raising a very important point, which is that disparity that exists in price, and that shows that every country really has its own way of looking at things, and what we decided to do is to really deliver on a value-based pricing approach because if we're trying to be consistent across the different European countries, the only way of doing that is to build our price based on the value we provide, meaning the cost that we reduce for many of these reimbursement agencies.
Actually you are raising a very important point, which is that disparity that exists in price.
And.
That shows that every country has its own way of looking at things and what we decided to do it from treaty.
Deliver on the value based pricing approach.
Trying to be consistent across the different European countries. The only way of doing that it was built on a price based on the value we provide meaning the cost that we reduce from many of these reimbursement agent. So that is the.
Kareem Mikhail: So that is, you know, the most straightforward way that will allow them, by the way, to compare and contrast our value compared to many of the products on the market which are not compatible. Because, as a reminder, we do not believe that we have a competitive product today. We are an indication that is not shared by any other molecule on the European market.
The most straightforward way that will allow them by the way the compare and contrast, I would've value compared to many of the products from the market, which are not comparable because of that.
We do not debating that we have a competitive product today, we are in.
Indications is not shared by any other molecule on the European markets technically speaking.
Kareem Mikhail: So technically speaking, you know, there is no one to compare us against, but still, they will compare the value we provide based on the events we reduce in terms of strokes, myocardial infarctions, and so on. So that's really what we are pursuing, and we are building our pharmacoeconomic models country by country, even in the countries where we're not requested by the process to submit. We are building them to demonstrate the value for each and every country. So shouldn't you have a price higher than PCSK9's then? Is that fair?
You know there is no one to compare us against but still.
Compare to the value we provide based on the events, we view concerning the stroke myocardial infarction and so on so that's really what we are pursuing and we are building our macroeconomic model country by country, even in the countries, where it would not requested by the process too.
We are building them to demonstrate the value for each and every country.
So shouldn't you have a pricing higher than pcf's canine spend is that fair.
Well.
Kareem Mikhail: Well, if we, you know, clearly are trying to, you know, share the evidence that we have better evidence comparatively, however, we should not forget where PCSK9s are in terms of the eligible patient population. So that's the important balance that we have to strike, right?
If we you know.
Clearly you're trying to.
Sure the evidence that we have better EBITDA.
However, we should not forget where <unk> are in terms of eligible patient population. So that's the important balance that we have to strike.
Kareem Mikhail: We know that with the evidence we have, we bring a lot of that. Okay, but many of these reimbursement agencies will multiply that price by the eligible population, and for them, it will have a very significant budget impact anyway. So if we go with an overly high price, what will end up happening is that we will limit the patient population that can benefit from the product. So, during the next month, this is what the negotiation is really all about, putting the scientific evidence in front of them, showing them how many patients will benefit from it, and trying to agree as to what is the most logical price that will give as many patients access while it still makes sense in terms of, you know That's really the exercise.
We know that when the evidence we have we bring a lot of that.
Okay, but many of these reimbursement agencies will multiply that price by the relationship with population and for them. It would have been very significant budget impact anyway.
So if we go with an overly high price what will end up happening.
We will limit.
The patient population that can benefit from the product.
So Julian the next month. This is what the negotiation is really all about putting the scientific evidence in front of the day showing them, how many patients who will benefit from it and trying to agree to.
What is the most logical price will give as.
Many patients the accident, while it still makes sense in terms of bringing their products to market that's going to be exercised.
Got it.
Kareem Mikhail: Got it. Thank you. Thank you. And the next question is coming from Paul Choi from Goldman Sachs. Paul, your line is live.
Thank you.
Thank you and the next question is coming from Paul Choi from Goldman Sachs. Paul Your line is live.
Operator: Thank you. And, John, it's been a pleasure as well working with you over the years. My question is on the US side with regard to pricing here, as you think about generic rollouts. I think, you know, some patients and provider payers are commenting on how net pricing for the FIFA is actually currently lower than for generics. So I was wondering if you could maybe just speak to how you think about discounting and or gross net adjustments to help maintain the moat around your Visipa franchise here in the U.S. And then with that, can you maybe just speak to, you know, what access has been like?
Thank you and John it's been a pleasure working with you over the years.
My question is on the U S side with regard to pricing here as you think about generic rollout I think some patients and providers payers are commenting on how net pricing for Vascepa is actually currently lower than the generic. So I was wondering if you could maybe just speak to how you think about discounting <unk> or gross.
Net adjustments to too.
To help maintain the moat.
Around your Vascepa franchise here in the U S. And then with that can you maybe just speak to what access has been like.
Operator: I think you've spoken in the past that, you know, it's still a decent amount of payers that reject Visipa here, despite the on-label usage, particularly given your potential change in growth to net dynamics and discounting. Thank you.
I think you've spoken in the past that you know, it's still a decent amount of payers, we reject vascepa here. Despite despite the on label usage.
Particularly given you're a potential change in gross to net dynamics and discounting. Thank you.
Paul Choi: Paul, thanks for the comments. So, you know, with regard to generic and pricing, a couple comments, and then I'll turn things over to Aaron Berg to talk briefly about our managed care coverage and the fact that it's, you know, continued to improve. So, you know, pricing is, as you know, but maybe, you know, others aren't quite as familiar with, you know, we've got branded pricing, you know, where we're selling, to the wholesalers, prescriptions are made, you know, reimbursed by, you know, managed care and, you know, along the way, we're providing, you know, cofee cards to reduce cost to patients and we're providing, you know, rebates to various managed care companies for access to, you know, ultimately get to the net price along the lines of what Karim is talking about.
Paul Thanks for the comp comments, so yeah with regard to generic pricing a couple of comments and then I'll turn things over to Aaron Berg to talk briefly about our managed care coverage.
<unk> continued to improve so.
Pricing as you know, but maybe others aren't quite as familiar with that.
We've got a branded pricing where we're selling.
Too.
So the wholesalers.
Prescriptions are made reimbursed by managed care and along the way we're providing.
Pay card to reduce cost to patients and we are providing.
Rebates various managed care companies.
For access ultimately get to the net price along the lines of what Craig's talking about so yeah, we can talk about wholesale acquisition price.
Paul Choi: So, you know, we can talk about wholesale acquisition prices, you know, where the WAC price of the branded product is about, you know, $344 per month and the generic product is about $302 per month, but, you know, with our rebates in place for many payers, I guess I'd say most payers, the net price to those payers is less after rebate than is the branded price and, you know, because, you know, many of the payers have not put the generic, it's really expensive, on to Tier 1, they've put it on to, you know, Tier 2, you know, some have excluded it, you know, the, you know, the patient is finding that the generic is often, you know, as expensive or more expensive and they can't use cofee cards with the generic product. But Aaron, you're much closer to this than I, so if you want to add any further color to that, let me know.
We're the WAC price of the branded product.
$344 per month.
And the generic products from $302.
But you know what.
Our rebates in place.
For many payers I guess I'd say, most payers the net price to those payers.
The last factor rebate that is deep.
And then is the branded price and.
Because many of the payers are not but the brand or generic guidance.
<unk> expense was onto tier one day.
Don.
Tier two.
The non preferred sort of excluded.
Yes.
You know the patient just finding that generic is often you know added expense of our more expensive, but they can't use co pay cards.
The generic profit product.
But.
You are much closer to the C&I. So if you want to add any further color to that let me know what in particular I don't know our managed care coverage.
John Theroux: But in particular, I don't know our managed care coverage since we got the label approved and launched a little over a year ago for cardiovascular risk reduction, but even over the last six months, it's continued to improve. So maybe you could talk a bit about that. Sure.
You know since we got the label approved.
And one little over a year ago for cardiovascular risk reduction, but even over the last six months has continued to improve so maybe you could talk a bit about that sure. So Paul that managed care is.
Aaron D. Berg: So Paul, managed care is obviously a question we get a lot. Perception tends to be greater than reality. So for everyone, since we're a broad audience, I'll try to paint a picture here.
Obviously the question, we get a lot perception tends to be greater than the reality. So far every once a super broad audience I'll try to paint a picture here overall access is very good. The business is split about 50 50 between commercial and Medicare part D and on a weighted basis, 75% of commercial and Medicare part D lives are unrest.
Aaron D. Berg: Overall, our access is very good. The business is split about 50-50 between commercial and Medicare Part D, and on a weighted basis, 75% of commercial and Medicare Part D lives are unrestricted. 96% of all Part D lives are unrestricted, and about 44% of commercial lives have a PA to the indication. That would typically be something along the lines of a patient on a statin with triglycerides over 150 and then an attestation for something around established cardiovascular disease or diabetes, and it could be a multiple risk factor.
<unk>.
96% of all part D lives are unrestricted.
There's about 44% of the commercial lives have a P a to the indication.
That would typically be something along the lines of.
A patient on a statin with triglycerides over $1 50, and then it adds.
Testacean force something around established cardiovascular disease or diabetes.
Could be.
<unk> risk factor. So there are a lot of patients.
Aaron D. Berg: So there are a lot of patients that certainly fall into that. But with the PA, it's a way that the plans are trying to manage the fact that this is a broad label and there are a lot of patients, a lot of patients that need a VASEPA. What we do to help manage that subsegment of the patients that have the PA is we work very closely with the office staff. We have other tools, a program called Karma Meds, and other things that help manage the PA process for that. But perceptually, we hear that PAs are rampant and that our coverage is terrible, but that's not fully accurate. It's this subsegment that we managed to capture.
Thats certainly fall into that but with the PGA. It's a way that the plans are trying to manage the fact that this is a broad label and there are a lot of patients a lot of patients that need vascepa on what we can do to help manage that sub segment of the patients that have the PAA is we work very closely with the office staff.
Have other tools program called cover my Meds, and other things that help manage through the PMA process for that.
What.
Perceptually, we hear is that <unk>.
Our our ramp in there.
Our coverage is terrible, but that's not fully accurate, it's a subsegment that we manage through it as John said, our progress has been very good since the beginning of 2020, when we got the label.
Aaron D. Berg: As John said, our progress has been very good since the beginning of 2020 when we got the label, a net of 55 million lives improved access for VISTIPA. We've reduced the number of commercial lives without any coverage from 15% to 5% and improved the number of commercial lives with coverage in preferred brands here from 68% to 80%. So what that means is the copay is on average around $33 and that's before our copay program, which we've had for a number of years and cuts the out-of-pocket costs for patients overall.
And then a 55 million lives improved access for Vascepa.
A number of other commercialized without any coverage from 15% to 5% and improve the number of commercialized with coverage improve preferred brands here from 68, 80%. So what that means is the co pays on average around $33 and that's before our co pay program, which which is certainly we've had that from <unk>.
Number of years.
The out of pocket cost for patients overall and then we've also improved significantly the number of lives in part D that are in preferred grand tier from 19% to 40% now so that also brings a co pay down to around 40% to $45. So.
Aaron D. Berg: And then we've also improved significantly the number of lives in Part B that are in preferred brands here from 19% to 40% now. So that also brings the copay down to around $40 to $45. So hopefully, that total picture demystifies some of what's going on with managed care and how it is overall imperfect as it is with most brands, but it's pretty good. And where it's not, we certainly do our best to manage that.
Hopefully that total picture demystify some of what's going on with managed care and overall imperfect as it is both brands, but it's pretty good and where it's not we certainly do our best to nurses.
John Theroux: And of course, prior optimizations are fairly common for lots of drugs these days. At the beginning of every year, different companies, unions, et cetera, pull these plans down on their employees and sometimes create some confusion. But, you know, that's not unique to BCIPA. Overall, the coverage has gotten to be, you know, very good.
And of course.
By organizations are fairly common lots of drugs. These days.
The numbers that are excited on the managed care level at the beginning of every year different companies unions et cetera pull these plans down there and employee employees, sometimes create some confusion, but that's.
That's not unique to Vascepa overall, our coverage has gotten to be very good in.
John Theroux: And, you know, at the beginning of the year, sometimes people see, you know, this beginning of the year insurance deductible, that is not specific to BCIPA. But, you know, often under plans, people have $1,000, sometimes $10,000, you know, beginning of the year deductibles. And that's because they go to the pharmacy to get a BCIPA filled, and all of a sudden, it looks like it costs a lot more. And that's because the beginning of the year deductible is kicking in, not because of, you know, a change in, you know, reimbursement for the BCIPA. You know, the generic has within, you know, various pharmacies created some confusion as well as, you know, generics. As pharmacists sometimes see a generic, and they assume it's... It's cheaper.
At the beginning of the year, sometimes people see.
You know theres beginning of the year insurance deductible, you know that is not specific to.
But paper, but often under plans that people have a $1000 from about $10000 beginning of the year deductibles.
They go to the pharmaceutical Vascepa fill then all of a sudden it looks like it costs a lot more and that's what got us at the beginning of the year deductible is getting in Africa.
A change in.
Reimbursement or vascepa.
The generic has within various pharmacies.
There is some confusion as well as generic as farmers are sometimes get generic and I assume it's John.
It's cheaper.
They are increasingly finding out that that's not the case, we're working on information informing them.
I just heard yesterday.
John Theroux: They're increasingly finding out that that's not the case, and we're working on information to inform them. I just heard here yesterday some anecdotal comments about, you know, patients going in for vazeepa prescriptions and finding, no, no, no, that's not available with me. So the education is working there, but compared to, you know, I think most brands are, as care coverage gets good, and if you look at the rate of prescriptions that are filled, you know, that fill rate for prescriptions is quite high So, hopefully, those comments are useful.
Yesterday, some anecdotal comments about.
Ah patients going in from Vascepa scripts in fighting.
That's not available with me.
So the education is working there but.
Compared to them.
Both brands are.
And care coverage is good and if you look at the us the rate.
Prescriptions that are filled.
The bill rate from prescription is quite high so hopefully those comments are useful.
Great. Thank you very much.
Thank you and the next question is coming from Jessica Fye from J P. Morgan Jessica Your line is lives.
John Theroux: Great, thank you very much.
Good morning. This is Daniel like Jessica I'll first Atlanta sat out congratulations to John on FX.
Operator: Thank you, and the next question is coming from Jessica Fye from JP Morgan. Jessica, your line is live. Good morning, this is Daniel speaking on behalf of Jessica Fye.
Central career.
You talked about matching your spending efforts from the U S to demand and or opportunity set at four day by the COVID-19 backdrop for the first for the next few quarters.
Jessica Macomber Fye: First, let us add our congratulations. Um, you talked about matching your spending efforts in the U.S. to demand and or offer that are afforded by the COVID backdrop for the first, for the next few. Should we just look at you managing the U.S. to essentially break even business from here? And if not, what would that look like?
Should we just look at you managing the U S to an essentially breakeven business from here and if not what would that look like.
John Theroux: Thanks for the nice comments and thanks for the question. You know, so, you know, we've been trying, you know, since COVID came out to manage expenses appropriately, you know, the, you know, trying to predict where COVID goes. This is tricky.
Thanks for the nice comments and thanks for the question.
So you know we've been trying.
Since COVID-19 came out.
Managing expenses appropriately.
Trying to predict where COVID-19 goes this is tricky.
Last year, we had pulled our sales force out of the field and entirely.
John Theroux: You know, this time last year, we pulled our sales force out of the field and entirely pulled back on, you know, our consumer initiatives. And in the September timeframe, it looked like COVID was pulling back, and we began to, you know, beat things back up again. And then, of course, there was another wave of COVID that came on in the fourth quarter, and we pulled back.
I'm going to pull back on.
Our consumer initiatives.
Denver is timeframe then it looked like the COVID-19 was pulling back and we began.
These things back up again, and then of course from another wave of COVID-19 that came on in the fourth quarter and we've pulled back.
Yes. The aim is to have the U S business will be profitable.
John Theroux: You know, yes, the aim is to have the U.S. business be profitable, which it has been. You know, some of these expenses are, you know, long-term items, you know, whether that's staffing, where, you know, we've not had an inordinate amount of turnover, but we've had some, and because of COVID, we've been a little slower than we would normally be in filling open positions as COVID recedes, we intend to, you know, get back to filling those positions.
And then.
Some of these some of these expenses are long lead items.
Whether that staffing where.
Yeah.
And in order to amount of turnover, but we've had solid because of COVID-19, but a little slower than.
We would normally be in billing.
Filling open positions as COVID-19 received we intend to get back.
John Theroux: But, you know, things like, you know, the consumer promotion, which often needs to be, have orders in place, you know, well in advance, they can probably see us, you know, creeping a bit back into that here, you know, later in Q2, provided that, you know, things continue to progress, but not as heavily as we might if we were sure that COVID was going to be back, you know, receding entirely. So, there will be attempts to match spending, you know, with these trends, but not all that spending can sort of be managed or pivoted, you know.
Filling those positions, but things like consumer promotion, which sort of needs to be have orders in place.
Well in advance they can probably see us creeping back into that here.
Later in Q2 provided that things continue to.
Our programmes.
Not as heavily as anybody that we were sure that COVID-19 was going to be back.
<unk> proceeding entirely so there will be an attempt to match spending.
With these trends but.
Not all of that spending and sort of manage or inhibited.
John Theroux: Immediately, but you know, the goal is to grow revenues and profits from the United States and, you know, through that expense management. So I can't really give you more, other than that being the objective and sort of the background. I can probably give you much more in terms of details of what those levels would be. I know that Aaron's commercial team here in the United States is happy to be in a field where it can be, looking for more and more access, always happy when we're spending more and very thrilled with the product, and continues to hear only positive things from doctors regarding the product, but we need the patients to be in the doctor's offices before we should be spending more money.
I immediately but the goal is to grow revenues and profits from the United States and.
Without this expense management.
And really give you more of the other thing that's been the objective and having sort of the background and can probably give you much more in terms of details of what those levels would be I know that.
Aaron's commercial came in here.
I would state is.
Israel.
Happy to be in a deal where it can be lumpy for more and more access.
Always happy when we were.
Spending more.
We're thrilled with the product and continue to hear all the positive things from doctors.
Regarding the product, but we need the patients to be in the Doctor's office with before we should be spending more money.
John Theroux: Hopefully, those comments help a bit. Thank you. Thank you, and that is all the time we have for questions today. I would now like to hand the call back to Jon Theroux for some
Those comments help a bit.
Thank you.
Thank you and that is all the time, we have for questions today I would now like to hand, the call back to John <unk> for some closing remarks.
Operator: All back to Jon Theroux for some closing remarks.
John Theroux: Thank you, everybody, for your interest. I know we went a long way today. I appreciate the questions. Hopefully, our comments were useful. This is a time of execution for the company, growing in the United States, launching in Europe, looking for an international expansion, and diversification beyond that. They're great people, a great product in the resources feed, and I look forward to continuing to support and watch the growth of Amarin as it moves forward.
Thank you everybody for your interest I know, we went a long way.
I appreciate the questions hopefully our comments were useful.
She is cream expressed at that time of execution for the company.
Growing in the United States.
Launching in Europe, looking for international expansion and diversification.
Suffocation beyond that.
Great people, great products and resources feed in.
I look forward to continuing to support and watched the growth of amarin as it moves forward.
Operator: Thanks, everybody. Ladies and gentlemen, this does conclude today's conference. You may disconnect at this time and have a wonderful day. Thank you for your participation.
Thanks, everybody.
Thank you ladies and gentlemen, this does conclude today's conference you may disconnect at this time and have a wonderful day. Thank you for your participation.