Amarin Corporation plc (AMRN) Q2 2020 Earnings Report, Transcript and Summary

Greetings and welcome to the Amarin Second Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Elisabeth Schwartz with Investor Relations.

Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including 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 purchases 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 drug like VASCEPA as a result of COVID-19; our current plans and expectations regarding our appeal of the District Court VASCEPA related patent litigation decision to the Federal Circuit; and our current plans and expectations related to the potential launch of generic versions of VASCEPA by generic companies and by ourselves, including expectations regarding ANDA approval by the FDA, generic cost effective supply availability, timing, potential levels of damages and ability to recover VASCEPA growth if the appeal succeeds; our current expectations for regulatory reviews outside the United States regarding VASCEPA approval; our goals regarding the timing, scope, and success of international expansion including expectations regarding our ability to launch VASCEPA in Europe and our expectations in China for clinical trial results and potential to bridge REDUCE-IT results in labeling and promotion of VASCEPA to our partner in China; and 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 and without entry of potential generic competition; and our current plans and expectations regarding clinical study of VASCEPA related to COVID-19 and regarding the results of the EVAPORATE study. These statements are based on information available to us today, August 4, 2020. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements. 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. For additional information concerning the factors that could cause actual results to differ materially, please see the Risk Factors section of our annual report on Form 10-K for the year ended December 31, 2019, and the Form 10-Q filed for the quarter ended June 30, 2020. These documents have been filed with the SEC and are available through the Investor Relations section of our website at amarincorp.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 its approved indication. An archive of this call will be posted on the Amarin website, also in the Investor Relations section. Making prepared remarks on today’s call will be John Thero, President and Chief Executive Officer; Aaron Berg, Chief Commercial Officer; and Michael Kalb, Chief Financial Officer. After prepared remarks, we’ll respond to questions. Some of you submitted questions in advance and were practical. We have tried to cover responses in our prepared comments. I remind you that, typically listening to calls of this nature are multiple audiences, including existing investors, potential new investors, employees, regulatory authorities, current and potential collaborators, and current and potential competitors. As always, in this call, we attempt to provide constructive information without compromising our competitive and strategic positioning. Please note that we anticipate the call be over in an hour. I now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Hello, everyone, and thank you for joining us today. During this call, we’ll cover many topics including, Q2 2020 operating and financial results, past and potential future impact of COVID-19 on our revenue growth and operations, commercial priorities in the United States including our recently launched promotion of VASCEPA via television commercials and related forms of communication, commercialization plans for VASCEPA in Europe, upcoming milestones including presentation of results of the VASCEPA clinical trial in China and results of the EVAPORATE study, and patent litigation status in the United States. We will start with this last topic first, as patent litigation is typically the first topic of enquiry from investors. As a reminder, this patent litigation is in the United States only and pertains to the rights to market and sell VASCEPA for its first FDA approved indication. The indication for lowering triglyceride levels in patients with very high triglyceride levels defined by FDA approved label and by medical guidelines, as triglyceride levels greater than or equal to 500 milligrams per deciliter. In Canada for example, we and our commercial partner did not seek that triglyceride lowering indication for VASCEPA. Similarly in Europe, we are not seeking that triglyceride lowering indication. Rather, our priority in such international labeling has been on cardiovascular risk reduction based up on the landmark results of the REDUCE-IT cardiovascular outcome study. Accordingly, the U.S. litigation does not directly impact a significant VASCEPA potential in those geographies, due both to new regulatory exclusivity and different patent protection. Or in most other areas of the world where we are pursuing or we may in the future pursue a cardiovascular risk reduction indication for VASCEPA. Our ongoing appeal to the Federal Circuit in U.S. patent litigation is in response to the decision in March of this year from the Federal District Court in Nevada, which ruled that the discoveries underlying VASCEPA’s patents that protected our initial FDA approved indication for VASCEPA were obvious. Thus, in effect, the court ruled that the patents upon which Amarin has relied should not have been granted by the U.S. patent office. This decision was unexpected by everyone, including we understand the generic companies involved in the litigation. As discussed in the past, we believe that the District Court decision is flawed. Having lived and worked through the early development of VASCEPA prior to the results of the MARINE and ANCHOR clinical studies, it is clear to me that the unique effects of VASCEPA were not obvious at that time to others outside of Amarin and that it was Amarin’s scientific insights developed over years of experience, which led to the successful development of VASCEPA. It was a development path that other scientists and other drug developers had not pursued. Nonetheless, a decade later, the District Court Judge in trying to go back in time, interpreted matters differently. Unfortunately, the judicial process is such that it doesn’t matter that I, you or others conclude that the District Court’s decision was wrong. It also doesn’t seem to matter that this District Court ruling if allowed to stand is likely to leave many patients unnecessarily at high risk for major adverse cardiovascular events, and potentially at unnecessary risk for other medical risks, which VASCEPA may be able to address in which we are in various stages of investigation. The potential benefits of which are less likely to be realized if VASCEPA becomes generic. Unfortunately for patient care, it is not enough to have extraordinary clinical results in FDA drug approval. Healthcare professionals and patients need product education. They could also benefit from continued investment in further research and development to continue to better understand the exceptional VASCEPA results achieved in the REDUCE-IT study, and how VASCEPA might help other patient populations. This important work for VASCEPA is only funded by Amarin’s promotion of VASCEPA as a branded product. Usually drugs become generic after they have been well established and are well known. But VASCEPA is not yet at that stage, and thus there is a major and unnecessary risk to patients and to society, that they could become deprived of VASCEPA-related education and scientific advancement, with resulting VASCEPA usage growth and patient benefits stymied by the potential premature introduction of generics. Furthermore, given the relatively high manufacturing costs and the affordable pricing Amarin has used for VASCEPA, if VASCEPA becomes a generic drug in the United States, we anticipate that little if any money is likely to be saved by patients or by insurance companies from the availability of a generic version of VASCEPA. There are many issues with the District Court’s decision that we would like to argue and have corrected by the court system. However, in our appeal to the Federal Circuit, we are advised by experienced and historically successful legal counsel that is best not to attempt to re-litigate all the matters that were previously argued in District Court. Instead of trying to correct everything, which we believe was wrongly interpreted or not understood by the District Court, we have prioritized matters that we believe are the most impactful to the 3-judge Federal Circuit panel that will be deciding our appeal. All written legal briefs to the Federal Circuit have been submitted to the court. This includes briefs on the behalf of both Amarin and the generic companies. Copies of these briefs are available through the court’s PACER website, and are also available within the Frequently Asked Questions section of Amarin’s corporate website. In addition to and separate from the required court briefs from the litigants, 2 third-parties submitted briefs to the court, expressing their views, both of which support Amarin’s petition, albeit with different considerations. One of these briefs came from BIO, a well-regarded biopharmaceutical Trade Association, which expressed the importance of the clear and consistent application of patent law and the value to society of being able to rely on patents to support innovation. The other brief was submitted by Aimed Alliance, a not-for-profit health policy organization that works to protect and enhance the rights of healthcare consumers and providers. Their brief emphasized that VASCEPA remaining branded would lead to increased education regarding VASCEPA, and improved knowledge among patients, caregivers, and healthcare providers about VASCEPA’s clinical trial results in its newly discovered benefits. The next significant step in our Federal Circuit appeal is expected to be the oral hearing. The oral hearing is scheduled for September 2 at 10:00 AM Eastern Time. Additional information regarding the logistics for this hearing, such as listening instructions are provided in the FAQ section of Amarin’s website. Based upon the history of the Federal Circuit, we anticipate their decision to be made public late this year or early in 2021. It is possible that the decision could occur surely after oral argument or take longer than anticipated. When decided the court’s practice is to post the decision through the court’s PACER system. Amarin will learn of the court decision at the same time as the public is made aware of the decision. The Federal Circuit at our request will quickly to schedule the oral hearing and hopefully that quick pace continues to reaching a decision on this important appeal. I won’t try here to fully articulate the legal arguments in Amarin’s appeal briefs. The lawyers who drafted them use arguments that should be clear to everyone who reads them. These briefs emphasize where we believe to be errors in the district court decision regarding application of the law and errors regarding certain facts, which impacted the district court’s decision. Some investors have asked whether settlement with the generic companies is likely before the Federal Circuit decision. While anything is possible at this stage such a settlement is unlikely. As a reminder, a settlement would only be useful to Amarin, if it’s settled with both of the 2 active and the litigants on mutually acceptable terms and also gets the district court’s decision vacated. If the district court’s decision is not vacated, our settling with the 2 generic companies that are litigants in this matter won’t stop other generic companies from seeking to fill the void. And it would then be more difficult to stop them. If the current district court decision is reversed is part of the current appeal. The situation is then more clearly in Amarin’s favor. For generic companies in general, the cost of anti-litigation is low relative to the potential benefit. That is – it is certainly much lower than the quest of developing a new drug. This relatively low cost combined with high potential reward, creates a scenario whereby some generic companies are willing to take the risk and seek near-term generic product opportunities even if the magnitude of such opportunities could be larger if they elected to wait. Whereas drug development is by necessity, typically a long-term endeavor, for various generic companies, the focus appears to be comparatively shorter-term. Currently, the ANDA filers for generic versions of VASCEPA, separate from preparing for the all of hearings in the Federal Circuit appeal or likely considering how much money they want to spend build supply capacity for VASCEPA. How long will take to build such supply capacity, whether they should build such capacity themselves from scratch or try to retrofit existing facilities. How to they gain the manufacturing know-how required for success in such challenging manufacturing and how much risk they’re willing to take. Amarin respects that getting an ANDA approved by the FDA is not trivial. However, keep in mind that there is no minimum supply requirement, it required for getting an ANDA approval. How much supply capacity is currently available and qualified for use by the generic companies is not directly known by Amarin. Based upon information available to us and based upon our own experience, we believe that existing capacity for qualified supply of generic VASCEPA is relatively small compared to the overall market opportunity. That doesn’t mean that such generic capacity is trivial. It’s conceivable that generic companies in the near-term can potentially find supply capacity to support tens of millions of dollars in revenue. However, while such level might be important to the generic companies, and Amarin clearly doesn’t want to give it up such level would only be a small portion of Amarin’s total revenue, and even a smaller portion of VASCEPA’s potential. Based upon information available to us today, if generics launch in the United States, it is our expectation that they would be launching with limited supply. We do not have direct visibility into this number, but that is our current understanding. We remind you that manufacturing of VASCEPA is not easy. The unique active ingredient in VASCEPA is fragile. For Amarin, it took many years and many millions of dollars to build our reliable supply chain for VASCEPA. Early on our cost of goods sold for VASCEPA capsules was much higher, but we lowered that costs through experience and investment and volume. Along the way, we worked with many third-party suppliers, some of which have succeeded in producing VASCEPA, and remain our suppliers and other companies which fail to produce VASCEPA consistently beyond the pilot stage. The manufacturing process involves multiple steps, all of which need to be completed efficiently and cost effectively. Moreover, quality, stability and consistency of the end product is paramount. The active ingredient of VASCEPA, if not stable and pure, is unlikely to have the same clinical effect, as was demonstrated by the high-quality product sold by Amarin. The generic companies, if they intend to become large suppliers of VASCEPA will have to demonstrate that they too can produce VASCEPA consistently with high quality and cost effectively at commercial scale. As we know, creating that capacity including construction, testing and qualification is expensive and time consuming. They may get there, but we don’t expect it to be easy or inexpensive for them. For these reasons, the return on their investment from building manufacturing capacity for VASCEPA is likely to be well below that of other generic drugs, where they can leverage existing infrastructure and expertise. In the early stages of producing VASCEPA, Amarin suppliers had significant challenges which they had to overcome. For Amarin, suppliers were interested in long-term collaborations for a growing product. This long-term growth opportunity motivated them to work with us and overcome these challenges. It also motivated them to make large capital investments to be rewarded with potential long-term global growth of VASCEPA with demand created by Amarin. Alternative potential future suppliers are unlikely to look at generic companies in the same light. Various suppliers have articulated to Amarin that they worry that the intention span of generic companies to individual products can be relatively short lived, making generic companies less dependable in making capital investment by the suppliers in support of generic companies more difficult to justify. At this time, no generic version of VASCEPA has launched and no pricing has yet been publicly listed for a generic version of VASCEPA. Such public posting or product price is a step required prior to the launch of any product, whether branded or generic. While it is possible that a generic version of VASCEPA could be launched at any time, currently, we do not anticipate a launch of a generic version of VASCEPA until after the Federal Circuit appeal decision, and then only if the generic companies win the appeal, and then only to the extent that the generic companies have qualified supply capacity. If they launch before the Federal Circuit decision, they would be doing so at risk of patent infringement damages owed to Amarin, which could be quite expensive to the generic companies, if Amarin prevails on appeal. The Federal Circuit is likely to reach a decision in one of three categories. First, the court could rule in Amarin’s favor. Not surprisingly, we clearly think that this decision is the best and most appropriate decision. However, while we believe that we have good legal arguments in that our patents should be upheld, and that we have a reasonable shot at winning, there is no way for us to guarantee that the Federal Circuit will decide in Amarin’s favor. Secondly, the Federal Circuit could rule in favor of the generic companies and confirm the district court decision. Such a decision would be disappointing on many levels. However, we’ve recognized that such a decision is possible, as overturning a lower court ruling has not been easy in the industry historically. Or thirdly, the Federal Circuit could remand the matter back to the district court for reconsideration by the district court based on guidance from the Federal Circuit regarding how to properly apply the law and/or how to consider certain facts. We cannot predict which of these 3 decisions will be reached by the Federal Circuit. We believe that we have strong legal arguments and a smart and experienced legal team that will argue for us in the oral hearing. However, as we saw on the district court decision, strong arguments and a strong team do not guarantee success. If we lose at the Federal Circuit, and generic VASCEPA becomes available, we will assess at that time, the degree to which we should continue to promote VASCEPA in the United States. In such a scenario, we envision multiple potential pathways to further value creation from VASCEPA in the United States and internationally. Again, based upon information available to us today, if generics launched in the United States, it is our expectation that they would be launching with limited supply, while we could of course, counter their generic launch with our own authorized generic and leverage the manufacturing cost efficiencies, which we have developed over multiple years. We believe that is more likely that a significant portion of the market will remain branded for a considerable period of time. As a reminder, VASCEPA is not a high price drug, particularly if generic companies have limited supply capacity, it would be unusual and somewhat nonsensical for them to sell limited supply at a low price. Because of our belief that branded VASCEPA will remain important in the United States and that VASCEPA is early in its launch in the United States and has broad potential globally. For the foreseeable future, Amarin intends to continue to purchase VASCEPA supply at levels previously described, with some modest adjustment for the hopefully short-lived unfavorable market growth impact of COVID-19. Similarly, as previously discussed, because a generic version of VASCEPA is unlikely to launch soon, and because generic companies are likely to have limited supply capacity for VASCEPA, even if they do win the Federal Circuit, commencing this quarter as previously guided, Amarin is increasing promotion levels of VASCEPA in the United States. If we lose in the Federal Circuit appeal, we will assess then whether we should further expand, contract or maintain such levels of VASCEPA promotion in the United States. As our Chief Commercial Officer, Aaron Berg will discuss further the market need and opportunity for VASCEPA in the United States remains high and currently most doctors and patients are unfamiliar with VASCEPA. VASCEPA has been approved for cardiovascular risk reduction only since December. In addition, many people think that they understand VASCEPA have only superficial knowledge of this unique drug. We believe that we can help many patients and grow considerably through increased promotion and execution. Our rate of growth in the near-term is heavily impacted by COVID-19. Accordingly, I will now pivot our discussion from the Federal Circuit appeal to discussion of Amarin’s operations in this challenging and unprecedented COVID environment. As you are likely aware, some companies have expressed concerns about declining revenues due to the impact of COVID-19. Amarin is pleased that its net total revenue in Q2 2020 of $135.3 million, increased 34% over Q2 2019. Our Q2 revenue growth was heavily impacted by COVID-19. While under the circumstances, we think that our reported growth is good, such growth level is well below our goals and expectations, if there were no COVID-19 pandemic. For further discussion of our Q2 results in the United States, and our plans for reaccelerating growth, I turn the call over to Amarin’s Chief Commercial Officer, Aaron Berg.

Good morning. John was absolutely right. While it’s good we grew VASCEPA in the second quarter despite the impact from the COVID-19 shutdown. We’re seeing some early signs of market recovery and confident that we can achieve more in the future. And we are inspired that we need to do more to improve patient care. Specifically, in light of the COVID-19 pandemic and the demonstration of patients with underlying cardiovascular disease or risk factors, including diabetes are more vulnerable to the virus, the need has never been greater for VASCEPA. As we discussed on Amarin’s last quarterly investor call. In Q1, we launched the new cardiovascular risk indication for VASCEPA, which included a newly expanded U.S. sales team to approximately 800 field sales representatives plus their managers to reach a broader base of irrelevant healthcare prescribers. These efforts helped VASCEPA show strong accelerating prescription and revenue growth in February and March. However, when the industry encountered the sudden and dramatic impact of the COVID-19 pandemic, the growth slowed as is the case with many branded pharmaceuticals. April was a particularly challenging month. However, recently, we’ve been witnessing signs of recovery in various aspects of the market and our business specifically. And while recognizing that COVID-19 will continue to present significant headwinds for the foreseeable future, cardiovascular disease remains the number one killer of Americans affecting millions of lives, and we intend to seize every opportunity to help these patients and reaccelerate our growth. During the height of the lockdown, reports from IQVIA indicated that patient visits to medical offices were down approximately 70% nationally. Similarly, they reported a significant drop in the number of routine laboratory tests, including blood tests being conducted. For a drug like VASCEPA to be prescribed for its cardiovascular risk reduction indication, often, physicians examine these patients and obtain laboratory test results for measures including cholesterol, triglycerides, and other important biomarkers. The slowing of VASCEPA revenue growth during the second quarter is not a reflection of reduced need for VASCEPA, but rather reflection that many qualified patients didn’t go to their doctors for routine preventive visits and blood work during the pandemic. To the contrary, we continue to hear very positive feedback regarding VASCEPA from healthcare professionals and patients. As has been widely reported, providers and patients became understandably focused on the urgent issues of the deadly COVID-19 pandemic, and patients have become less inclined to seek medical care for less acute concerns. Creating further challenge for VASCEPA prescription growth was that we’ve historically focused on efficiently promoting VASCEPA primarily in more concentrated geographies. As a result, VASCEPA volume is disproportionately high in areas such as New York City, Los Angeles, and other hotspots that were significantly affected by and closed down during much of Q2. While challenges remain, some of these areas have started to reopen, and we’ll be opportunistic in pursuing growth wherever and as rapidly as possible. Starting in mid-March when we initially suspended face-to-face interactions between our sales representatives and healthcare professionals, our aim has been to find innovative ways to maintain communication with VASCEPA prescribers and patients to provide the information and support they need. The actions of our sales and marketing teams have increasingly utilized virtual educational programs, including digital outlets to engage healthcare providers, less knowledgeable about VASCEPA’s benefits as well as maintain the continuum of care for patients already prescribed VASCEPA. Here, ironically, we found that some doctors were more engaged in learning about VASCEPA’s clinical results, and actually took more time to ask questions, as they may have been seeing fewer patients during Q2. However, as you’d expect, many healthcare professionals were focused on other critical matters, and as a result, were difficult to engage during the height of the pandemic. We also use this time as an opportunity to continually train our field sales organization, many of whom joined us only months ago, to better prepare them to be rapidly productive as direct face-to-face sales interactions were reinitiated. Amarin is a data-driven company that cares about patient care, and cares about our employees. Just as we believe that we were responsible in March, when we were one of the first companies to announce that we were suspending direct sales interactions with customers; in June, we began to test safely getting some of our sales representatives back in front of healthcare professionals on a face-to-face basis in a manner consistent with CDC state and local regulations. During late June and further in July, we gradually increased the number of sales representatives, who have resumed direct sales interactions. Now in early August, much of our sales forces in the field with an ongoing learning curve regarding how best to interact with healthcare professionals in this very dynamic COVID-19 environment. Not all doctors currently and consistently allow sales representatives into their offices. And some areas of the country which started to open have closed again. We expect the need to continue to adapt to this environment, and while our TRx levels are above pre COVID-19 levels, the productivity of our sales team remains slowed by COVID-19 related challenges. We intend to remain flexible and responsible. Our priority is patient health. Given the persistent cardiovascular risk, which exists in so many patients and the multiple adverse potential consequences of such risks, we need to ensure that their doctors are well aware of the demonstrated clinical profile and unique FDA approved indication of VASCEPA. And we’re determined to capitalize as the market recovers. According to IQVIA data, patient visits to physicians increased considerably in June compared to the lows of April. However, while patient visits were higher in June than in April, they remain down approximately 34% compared to pre-COVID-19 levels. Similarly, the number of lab tests in June also remained well below pre-COVID-19 levels. This third-party industry data reflects continued patient fear and apprehension. While such cautiousness is understandable, patients with high cardiovascular risk appear to be at increased risk of complications from COVID-19, which further points to the increasing importance of preventive cardiovascular care. We still have a long way to go in reaccelerating and maximizing VASCEPA growth, but we’re confident and determined to make it happen. Sales force morale is high, turnover low, and representatives are excited to be out in the field talking about VASCEPA. We’ll no doubt continue to face COVID-19 related challenges, but we will continue to do what we believe is best for patient care and for our employees. Regarding VASCEPA results in Q2, based on monthly U.S. data provided by third parties, Symphony Health and IQVIA, the estimated number of normalized total VASCEPA prescriptions for the 3 months ended June 30, 2020, compared with the same period in 2019, increased 44% and 47%, respectively. Normalized total prescriptions represent the estimated total number of VASCEPA prescriptions dispensed to patients calculated on a normalized basis. For example, one-month supply, or total capsules dispensed multiplied by the number of grams per capsule divided by 120 grams. Based on data available to us, VASCEPA inventory levels at wholesalers were within the normal industry range at the beginning and end of Q2 2020. While it’s difficult to predict the rate at which society will reopen from COVID-19, the patient need for VASCEPA remains high, yet awareness of VASCEPA is low, and with no direct competition. Prescription growth appears to be very sensitive to generating educated awareness of the clinical benefits of VASCEPA with key healthcare professionals and patients. We need to continue to seize this opportunity for the benefit of patient care. Remember that the VASCEPA cardiovascular risk reduction indication was approved by the FDA just this past December, and without education by Amarin, many doctors won’t learn about it. Continued consumer and healthcare professional focused education remain a top priority for our business, as there is sufficient need to increase awareness of VASCEPA. During recent awareness study among about 300 randomly selected cardiologists, endocrinologists and primary care physicians, unaided awareness of VASCEPA for cardiovascular risk reduction was just 32%. Among 302 statin-treated consumers with triglycerides above 150, unaided awareness was less than 1%. While VASCEPA awareness is higher among doctors directly called upon by our sales team, even for most of those doctors, continued education and increased awareness is important. To augment our ongoing activities to educate healthcare professionals via the sales force and other initiatives, in mid-July, we launched our first ever direct-to-consumer campaign for VASCEPA focused on the use of VASCEPA for cardiovascular risk reduction with emphasis that VASCEPA is the first and only product approved for its cardiovascular risk reduction indication. The new promotional campaign focuses on persistent cardiovascular risk, and the benefit of VASCEPA to reduce risk of a heart attack or stroke by 25% when added to a statin. The campaign, which is intended for patients and healthcare professionals, encourages patients to ask their doctors about VASCEPA. For FDA regulation, promotional drugs must include fair balance of information about drug risks. In the span of our 60 second TV ad, we wanted to make sure that we communicated some key points including 25% risk reduction, and first and only drug with this important new indication. To make such claims, we need to include safety discussion in a manner, which will be understood by patients and consistent with FDA feedback and labeling. Hopefully, it will be clear to most people that for FDA to approve VASCEPA for this important new indication, the benefits are deemed to outweigh the risks. At a minimum, we’re hoping that the ads get doctors to think more about VASCEPA and get patients to ask their doctors about VASCEPA. VASCEPA is used to treat high risk patients, was studied over an extended period of time, and as per medical publications, VASCEPA was well tolerated and safe. The 25% risk reduction on top of statin therapy is unparalleled. And as a result, many medical societies recommend that VASCEPA be used to effectively treat appropriate at-risk patients. Hopefully, more patients will ask their doctors about VASCEPA as we increase awareness. This new campaign has many components, including a national TV schedule, social media channels such as Facebook, Instagram and YouTube and other forms of outreach and education, includes increased visibility in telemedicine and these components are being rolled out over the course of Q3 and beyond in a stage manner. Such communications emphasize that VASCEPA is the first and only drug, which is FDA approved for this use. As Amarin expressed previously, we understand that the investment is such promotion is not inexpensive, but we believe that the result may help improve patient care for potentially millions of people, and that the cost of such promotion will be covered by growth in VASCEPA revenues. Historically, for other products, brand perception and recognition evolves as people see such promotion multiple times. We hope and expect for VASCEPA promotion and education to be both significant and sustained over an extended period of time. For society, savings from effective preventative care come from fewer high cost heart attacks, strokes, and other cardiovascular events, which also helps keep patients and their families productive. In tandem to our awareness campaign, we’re also investing in improved patient access and reimbursement for payers. Our managed care coverage has been improving, as managed care plans increasingly learn about the recent FDA approved indication and recognize the value of VASCEPA. As we’ve described previously, VASCEPA is on formulary for the vast majority of payers, and we’ve been working to improve access and reduce out-of-pocket costs and restrictions for patients by improving formulary positioning to preferred tier status. During 2020, some payers that were previous outliers and didn’t cover or restricted VASCEPA improved access as many elevated VASCEPA to preferred tier status. Some holdouts remain, but more than 3 quarters of insured lives or commercial insurance plans are now with payers that have VASCEPA on their preferred tier. Some of this improved coverage occurred in Q1 and Q2 of this year, with some additional improved coverage, becoming effective starting in July. It’s reassuring to witness the value of VASCEPA being increasingly recognized by these payers. Some of this has been aided by patients and healthcare professionals emphasizing the need for VASCEPA to be covered. Such support helps, and we’re thankful to everyone who’s reached out to payers to ensure that VASCEPA is readily available and affordable to all patients who need it. Overall, while the impact of the COVID-19 pandemic to the launch of VASCEPA cardiovascular risk indication, and to the industry as a whole has been significant or hopeful the modest yet encouraging early signs of recovery continue. Thus far, one of the most encouraging signs of recovery, the recent accelerated prescription growth in our target physicians in particular cardiologists. We’re increasingly committed to reaccelerating the VASCEPA growth during the balance of 2020 and beyond. We anticipate continued challenges and unpredictable recovery from COVID-19 and can’t predict with accuracy how rapidly we’ll grow. However, we know we have a significant opportunity are confident that we have the product, the people and the resources to be successful and fully intend to maximize this opportunity for the benefit of patient care and our shareholders. John?

Thank you, Aaron, for those helpful comments and perspectives. I too, I’m confident that we will succeed in reaccelerating VASCEPA growth in the United States. Echoing your comments about people at high risk for adverse cardiovascular events not getting much needed medical care, resulting in unnecessary medical issues including unnecessary deaths. An analysis published in July by the Washington Post suggested that in 5 hard hit states in New York City there were 8,300 more deaths from heart problems than would have been typical in March, April and May, an increase of roughly 27% over historical averages. While several experts said some of the excess deaths in the analysis were almost certainly unrecognized fatalities from COVID-19, the review suggests that many patients suffering from serious conditions died as a result of delaying or not seeking care as the outbreak progressed and swamped some hospitals. The data further highlights the need for preventative cardiovascular care and proven effective therapies. We are hopeful that people will start to more aggressively seek out care for their cardiovascular issues. In light of the COVID pandemic and the demonstration that patients with persistent cardiovascular risks are more vulnerable to the virus and the great costs to patients and society from strokes, heart attacks, other major adverse cardiovascular events, as VASCEPA has been demonstrated to reduce, the need has never been greater for VASCEPA. Outside the United States, there is also significant opportunity for VASCEPA. In Canada in February, VASCEPA was launched by our commercial partner HLS Therapeutics. In China, before the end of this year, we anticipate results to become public of the VASCEPA clinical trial being conducted there by our partner. In Europe, we are giving priority to getting VASCEPA approved, which approval will be followed by plans for seeking reimbursement and commercial growth. And after we get going in Europe, we will further consider options for accelerating expansion of VASCEPA into other parts of the world. Turning now to a discussion of our plans in Europe, where our top priorities include regulatory approval, country-by-country reimbursement and successful commercial launch. As was the case in the United States and Canada, the VASCEPA review by the European Medicines Agency, or EMA, is comprehensive. We believe that we have good responses to the questions that they’ve asked thus far, and that we have not seen any red flags. The questions being asked are typical for a product such as VASCEPA. We plan to continue to work diligently to respond to potential additional questions as they arise during this review process. Assuming that EMA completes its review and recommends approval of VASCEPA, such recommendation is typically promptly followed by product approval by the European Commission. The EMA review process appears to have incurred some modest impact from COVID-19, but generally remains on track to support an anticipated favorable recommendation by EMA, followed by product approval by the European Commission currently anticipated in early 2021. As we approach anticipated regulatory approval of VASCEPA in Europe, we have spent this year further evaluating options for VASCEPA commercialization in Europe. Such evaluation included weighing the benefits and costs between engaging a large pharmaceutical partner, or retaining the commercial rights and launching VASCEPA on our own, at least in larger countries of Europe. In parallel with this evaluation, we have been building awareness for VASCEPA in its cardiovascular risk reduction benefits among the cardiovascular medical societies and thought leaders in Europe. As you may recall, while not yet approved for sale in Europe, VASCEPA has already been included in the medical treatment guidelines of the European Society of Cardiology and the European atherosclerosis society. In addition, we have been conducting market analysis and payer access research in order to size the market opportunity and prepare for anticipated reimbursement negotiations in various countries within Europe. Importantly, our intention under any commercialization scenario was to manage the supply chain for VASCEPA in Europe. And we have been working behind the scenes on these logistics. VASCEPA represents a potential multibillion-dollar opportunity in Europe. 3.9 million Europeans die annually of cardiovascular disease, representing approximately 45% of all deaths, and over 80 million Europeans have cardiovascular disease. A recent survey showed that about 25% of a representative sample of more than 7,800 patients in 27 European countries with coronary heart disease and controlled LDL cholesterol levels had elevated triglyceride levels greater than 150 mgs per deciliter, illustrating the potential pervasiveness of high-risk cardiovascular disease in Europe, beyond currently available therapies. Given the enormity of this opportunity, we have been working with many advisors regarding how best to commercialize and maximize shareholder value with the VASCEPA in Europe. We reviewed multiple proposals from pharmaceutical companies that wanted to commercialize VASCEPA in Europe. Our reviews included analysis of the economic terms, potential product penetration, the priority that VASCEPA might get in promotion by such companies versus Amarin, doing it ourselves, and whether a third-party would fight as hard or convincingly for VASCEPA’s reimbursement in Europe. These decisions also impact pricing of VASCEPA in other geographies, in other potential future strategic opportunities for Amarin. Investors who shared their opinions with Amarin almost unanimously expressed support for Amarin retaining rights to VASCEPA in Europe, unless the deal terms for Europe wherein what some called the no-brainer or what other called the too-good-to-be-true category. As we announced in a separate press release today, we have concluded that the best path forward for our shareholders is for us to retain the full upside potential of VASCEPA in Europe, and to not split such economics of this opportunity in Europe with another pharmaceutical company. Rather, we are confident that we have the ability to create greater value by launching VASCEPA in Europe through an Amarin team. This approach ensures that the team, which best knows the science and clinical results from VASCEPA are leading and seeking reimbursement on a country-by-country basis for this important product. And similarly, this approach ensures that VASCEPA gets the highest level of priority from sales representatives and promotion. While proposals from other companies to partner with Amarin for commercialization of VASCEPA in Europe were thoughtful. In the end, we concluded that it is important to ensure that we not run the risk of the focus on VASCEPA getting diluted by other products promoted by such companies. And that is important for Amarin to preserve optionality for potential future strategic opportunities. Our plan for commercial launch in Europe is to develop the foundation of our commercial team using similar principles to what we did in United States. We are hiring professionals in key roles and leveraging third-party relationships through various support activities. This may include local partners, when it makes sense in certain smaller markets. Launching on our own will result in a tight focus on the largest markets in Europe. We believe that Amarin’s current financial resources are adequate to properly launch VASCEPA in Europe. To further prepare for the successful launch of VASCEPA in Europe, we recently hired a head of commercial for Europe, including sales, market access and marketing. We are very pleased to welcome Mr. Karim Mikhail to the Amarin team. Karim joins Amarin with an impressive pedigree, including decades of relevant experience, and a proven track record launching cardiovascular products in Europe. Previously, for example, Karim launched Ezetimibe in France, and was Merck’s head of global cardiovascular products, a $4 billion enterprise. Karim brings to Amarin a strong network of contacts and extensive European experience, including pricing and payer access expertise. Importantly, Karim shares our excitement and vision for VASCEPA and its potential in Europe. We have informed companies that expressed interest in VASCEPA rights in Europe that we appreciate their interest, but are no longer pursuing a partner for VASCEPA in Europe. Due to the confidential nature of such partnering interactions, we cannot share with you the details of proposals we received, other than to say that there was sincere interest and the proposals gave us plenty to think about, but the proposals, clearly, were not of the yoke described by shareholders, as no-brainers or too good to be true. Building off the work that we have already done to build awareness for VASCEPA in Europe and seek regulatory approval, we are pursuing plans for Europe, which emphasize efficiency and productivity. Our measure is not to maximize revenue, but rather to maximize value per share. We believe that we can best do this through focus and emphasis that quality with high productivity is more cost effective than throwing a lot of money at the opportunity, particularly before the product has established reimbursement in large countries in Europe. Please do not misinterpret my comments about being cost effective to suggest that we do not intend to be serious. We believe that this is a very large market opportunity. We intend to address it robustly, but smartly. Similar to what we did in the United States, we are hiring people into key roles and leveraging third-party relationships for various support activities, which exist elsewhere and are not essential for us to recreate. Karim is heading our European commercial team. We have experienced people in our team to provide him support, and we are confident in our plans to expand the core team to focus further on product reimbursement and launch plans. Based upon feedback thus far, we are confident that we will find additional highly experienced people as needed. Market access is key to the success of any product in Europe. Continuing to build medical support for VASCEPA in Europe should be helpful towards gaining reimbursement for VASCEPA. After VASCEPA is approved and this reimbursement process is further advanced, we hope to be in a better position to comment on the timing of such reimbursement. Given that no other product has the clinical results demonstrated by VASCEPA, we are optimistic that we can achieve appropriate reimbursement for VASCEPA in a timely manner in most countries of Europe. Relatedly, Amarin recently received its first new patent allowance for cardiovascular risk reduction, with use of VASCEPA in Europe. As previously discussed, European regulatory approval of VASCEPA as a new active substance should provide market exclusivity into 2031. This new patent should extend that exclusivity through 2033. We have additional patent applications being prosecuted for Europe, which could potentially extend VASCEPA patent protection in Europe into 2039. These potential additional 6 years could be quite valuable. Pertaining to building medical awareness of VASCEPA in Europe, Amarin is supporting multiple scientific presentations at the European Society of Cardiology or ESC meeting from August 29 to September 1. The meeting, which is being conducted virtually, is the largest cardiology society meeting in the world, with potentially of 10s of 1000s of participants. This year’s meeting has no registration fee, and provides an opportunity to further showcase data regarding VASCEPA. One of the presentations accepted as a late-breaker at ESC is presentation to the final EVAPORATE clinical trial results. As many of you know, the EVAPORATE clinical trial use imaging to evaluate the effects of VASCEPA as an adjunct to stent therapy on plaque buildup in human arteries, as is characteristic in patients with high persistent cardiovascular risk factors. The interim results based on scans at 9 months were presented at the 2019 AHA meeting and were recently published. The interim results were encouraging regarding limiting plaque buildup and potential plaque regression. We look forward to hearing the final results of EVAPORATE at ESC, as well as other data being presented at this meeting. As mentioned in our last investor conference call, we are in the early stages of exploring whether VASCEPA can help reduce COVID-19 risk or mitigate the severity of COVID-19 infections. Scientific leaders and Amarin believe that VASCEPA’s established safety and efficacy profile and potential anti-inflammatory, anti-thrombotic, endothelial and antiviral effects could be useful to altering the natural history of COVID-19. We are hopeful that VASCEPA can be useful to help people avoid the complications that can come from this terrible virus. We have moved beyond the theoretical and into clinical testing. Some information regarding such studies is available on ClinicalTrials.gov. While we see a good scientific rationale for such studies, until we have data from such studies, we don’t intend to comment in detail on the studies or to predict the results of such studies or the level of additional study, which might be needed if these pilot studies are successful. Amarin remains active in advancing the science around VASCEPA. Even prior to the upcoming scientific presentations at ESC, Amarin this year has already supported more than 35 scientific publications or presentations pertaining to VASCEPA and its unique active ingredient in the demonstrated positive clinical effects. Our Chief Financial Officer, Mike Kalb, will now comment on our financial performance. Mike?

Thanks, John. I’m encouraged by our financial performance during the first half of 2020, as we recorded total revenue of $290.3 million, a 67% increase compared with the first 6 months in 2019. And we were able to achieve this growth despite the headwinds from the COVID-19 pandemic. As a reminder, Amarin recognizes product revenue in the United States based on sales to wholesalers and specialty pharmacy providers in the U.S., or collectively, its distributors or its customers, in accordance with Generally Accepted Accounting Principles, and not based on prescription levels reported by Symphony Health and IQVIA. During the second quarter of 2020, we reported net product revenue of $133.7 million, a 33% increase compared with the second quarter of 2019. And we achieved $285.9 million in net product revenue for the first 6 months of 2020, representing a 65% increase, compared with the same period in 2019. These increases were largely driven by increased U.S. VASCEPA sales, as well as a modest increase in VASCEPA’s net selling price in the United States, which reflects some of the managed care coverage improvements that Aaron spoke about earlier. Amarin continues to maintain strong gross margins with overall gross margin on net product revenue of approximately 78% for the first half of the year. This slight increase compared to the same period in 2019 is driven by gross margin on U.S. product sales of approximately 80%, which is partially offset by the gross margin on ex-U.S. product sales to our global partners as per contractual arrangements. Although we’ve continued to make improvements in our gross margin, VASCEPA continues to have a lower gross margin than many other branded drugs, due to its affordable pricing and the cost incurred due to the complexity of manufacturing, the active pharmaceutical ingredient or API, at the high-quality standards we have set for VASCEPA. Under U.S. GAAP Amarin reported net income of $4.4 million in the second quarter of 2020, or basic and diluted earnings per share of $0.01. With disciplined expense management, and by temporary suspension of face-to-face interactions, and other selling and marketing initiatives in the second quarter of 2020, due to shelter-in-place and other travel restrictions resulting from the COVID-19 pandemic. I think this is particularly noteworthy as we were able to achieve net income despite the limitations to our potential revenue growth resulting from the reduction in patient visits to their physicians and the resulting impact on new prescriptions for VASCEPA. In June, we reinstated our U.S. educational and promotional programs for VASCEPA. And as a result of restoring these initiatives, and with the continued uncertainty around the impact from COVID-19 moving forward, it is uncertain whether we will achieve net income in the second half of the year. Further, we anticipate SG&A expense to be approximately $10 million to $20 million higher in the second half of 2020, compared to the first half of 2020. As of June 30, 2020, Amarin had cash investments in excess of $600 million, accounts receivable net of $125 million, and inventory of $124.8 million. We continue to maintain a strong balance sheet and believe our current resources are sufficient to fund our projected operations including our anticipated spend on the direct-to-consumer campaign, for VASCEPA in the United States and successful commercial launch in Europe. With that financial overview, I will now turn the call back to John, for closing remarks. John?

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

Thank you. At this time, we’ll be conducting a question-and-answer session. [Operator Instructions] Your first question comes from line of Ami Fadia with SVB Leerink. Please proceed with your question.

Good morning. Thanks for taking my question. I had some follow-ups on your comments and thank you for the detailed comments. That was very clear. Just with regards to the U.S. patent litigation and the potential risk of generic entry, can you talk to the cost of goods that you had at the initial launch time period, so we get a sense of what cost of goods could be for generics should they launch? And could a settlement be possible after the hearing on September 2? And then, I have a second question on Europe.

Ami, thanks for the questions, good morning. Regarding cost of goods sold, I’m going to put this in the context of gross margin. But remember, our net selling prices have been roughly flat for a long period of time, so the change that has occurred is just as a result of lowering product cost. So when we initially launched, our gross margins were in the low-50%s, I believe, and took a lot of work to get them into the 60%s, and then we’ve been migrating through the 70%s to now to the point where we’re high 70%s, and last quarter, we hit 80%. And that is a result of a lot of work by Amarin, by our suppliers, and efficiencies and knowhow and capacity and scale. So it’s not been easy, a lot of mistakes, a lot of learning along the way. But we’re proud of what’s been accomplished there. In terms of settlement, as I attempted to express, to settle is tricky. We got to settle both with the 2 – both Hikma and Dr. Reddy’s are 2 litigants, but also have the court decision essentially reversed. If the court decision were to remain in effect, such that the patents on the first indication for our product were deemed to be obvious, our settlement with those 2 players would then allow other players to fill that void and come in, because there would in effect be no patent coverage. So we think our arguments are good. We’re looking forward to the oral arguments. We’re hoping that the legal system will appreciate these arguments and do what we think is right, but at this point in time we’re not relying on a settlement. Anything’s possible, but we’re not relying on or predicting settlement.

Okay, great. With regards to the decision to launch yourself in Europe, can you elaborate on kind of how you thought about the value creation for shareholders that you can have by going it alone versus partnering right in Europe, kind of to a large pharma company? And how do we think about the use of cash? As you continue to market the product in U.S., at least, in the foreseeable future, and ramp up in Europe, can you talk to some of the investments that will be required in Europe over the course of the next maybe 12 to 18 months, in terms of the number of people on the field, et cetera? Thank you.

Yeah. So, thanks for the questions. Regarding Europe, we started with a review of the opportunity to make sure that we understood normally and weren’t drinking our own bathwater on that. And all of our analysis that we did, including interaction with doctors, but also use of various consultants came back to confirm to us that this is a very large market opportunity. And, we see key opinion leaders over there, urging the drug get approved and asking us how this drug is going to be introduced and very much interested in the drug. I think the 2 leading medical societies jumping out as quickly as they did last year to add to guidelines as an example, but not the only example of that visible need. And then, we spend a lot of time looking at could we do this, and also, what would be available to us from a partnering perspective, and what we think to be on a risk adjusted basis, the value creation for our shareholders on Path A versus Path B. And all told, we saw a high need. We saw a lot of very experienced people, who could help us with it. We’re thrilled to have Karim Mikhail join us to lead the commercial efforts. I think that’s an example of the high-quality people that are available to us. And while working towards the regulatory approval, working to make sure we have supply in place, we’re working to make sure that we have – when I say supply in place, it’s all the logistics. It’s the same product, but making sure it can get into the countries. We decided that it was in our best interest to retain the rights to the product. We think that that provides more value under the curve for our shareholders. We’re not sharing the economics with somebody in pursuing success here, while we would be funding the course, and I’ll get to that in a moment, we will be retaining all of the profits from that opportunity. And to the extent that we see other products that we might develop or otherwise would become available to us having our own team in place, not just in the United States, but in Europe, provides greater leverage and value there. Right now, the primary focus is getting the product approved. We are doing the support tasks, like making sure we have supplier logistics, we’re doing lots of planning, we’re doing lots of interactions with KOLs, making sure we’re ready for the various reimbursement arguments and advancing reimbursement arguments to the extent that one can prior to approval. In many countries that can’t be advanced until you actually have the pack have the label. Initially, meaning this year, we’ll use the team that we have in place. Remember, we are an Irish company. So we do have a team in Dublin that’s important to us. Karim will develop teams probably this year. Roll a couple of dozen people, core team continuing to use consultants and third parties to leverage that. And as we get along further in the reimbursement side of things which will be on a country by country basis, some undoubtedly faster than others, that’s not unique to us. Despite our very strong arguments, we believe that VASCEPA should have a net price in Europe that as high, potentially higher than we have in the United States, because we’re launching again. In Europe, for cardiovascular risk reduction, whereas when we launched in the United States, we launched into a – from a genericized market for triglycerides, lowering without outcomes data, but we want to make sure we have that reimbursement in place before we really ramp up and add much more significant costs. We’ll have further comments on our European launch plans, in conjunction with the approval of the product. We do appreciate the proposals that we received that did give us a lot to think about. But in the end, this is about shareholder value. And we think that retaining the economics to our pulley to ourselves, that this is manageable, we have the resources to do it, and that with the right people, we’re going to be successful. So it’s exciting for us.

Okay. Thank you so much.

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

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

Good morning, Louise, lots of questions there. Regarding the international process, our proposals from various companies are confidential in that process. And, we’ve made our decision to move forward with going direct in Europe. I think that that is the right decision, there was considerable interest. VASCEPA is an important product. It’s a growth opportunity. And, we’re always out to look to do what’s best for our shareholders. But I’m not going to speculate on anything that we haven’t made decisions on right now. We’re very excited about the European opportunity and we’re going to focus in on the execution that’s needed to continue to create value through getting the product approved in Europe getting reimbursement in Europe and growing it and then using that to springboard potential additional opportunities in the rest of the world. We’re obviously also looking forward to the results of the trial in China becoming available later this year. And from that, you’re working with our partner there on what the right regulatory strategy is for China. With respect to gross margins, we – when I joined, Amarin in 11 years ago, we were already working with suppliers at that point in time on building supply. And it’s been over a decade to get to the stage where we’re at. Just in the last year we took steps to increase the lot sizes that were being produced and the type of containers that are being used, and other process efficiencies. So we’re continuing to look for ways to iterate and improve and diversify, because we don’t want to be relying on any one supplier. We’re fortunate to have very good suppliers competing with each other on a basis of ensuring a high-quality product at efficient costs. So it certainly didn’t happen overnight. Those early years were somewhat difficult from a supply perspective, lots of learning along the way. And we’ve got a very good quality organization here, very good CMC organization that’s been able to work hand in hand with our suppliers to ensure that we have the level of quality that is important. This product doesn’t work as well, if it’s not made to that high-quality standard, and that standard isn’t just leaving the manufacturing plant, it’s the delivery to the patient in that stable form. So it’s a significant area of investments in the area of know-how that many – good companies try to become suppliers for us along the way and failed. With regard to growth, that’s hard to predict in the COVID era. We understand that the need is there. The patients have no high need, we understand that there’s still very limited awareness, doctors who are learning of the drug, believe in it, the prescribe it. We’re seeing increased prescriptions, but if patients aren’t going to their doctors and patients aren’t going to get lab tests, it’s hard to prescribe a new drug to those patients. So as we are in the very early stages of getting back out there in terms of direct interactions. We’re seeing particularly amongst the cardiologists that were able to start getting into in the late June and early July timeframe, some signs of increased prescriptions, but this is very early and based upon your very limited sales calls and there can be no assurance that those parts of the country, where we’re able to call on people don’t shut themselves down again. So I think the macro picture is very positive relative to the opportunity for VASCEPA. But being able to predict, in the shorter term, how the growth will occur, I suspect it will continue to be somewhat volatile. But we’ve got good people believe in the product and we think we’re going to be able to work our way through it. It was a tough quarter with the sales – our sales team, adjusting to all that face them, and I think we’re coming out of it even stronger, and we’ll continue to look for ways to continue to adapt. I will comment that – we had, I think, good growth under the circumstances. Some people probably will get into trying to reconcile scripts with revenues. As a reminder in Q1, revenues exceeded – revenue growth exceeded script growth. This quarter, script growth was slightly faster than the revenue growth at least on a comparative basis to Q1, those types of things happen. That’s the nature of estimate provided for – by scripts. I also remind folks that, in Q1, we had some anomalies that we talked about and reporting of that quarter. We had effectively an extra week of shipping to wholesalers or revenue to recognize based upon the shipments of wholesalers. So in Q1, we had right around $11 million of revenues resulting from that extra week of shipment. We also had our Canadian – our partner stocking up for launch, which we disclosed in the first quarter was about $6 million, it was a little less than last year in the second quarter as I didn’t have to restock. So I think all told, we had good growth in the first – a terrific growth in the first quarter, we’re disappointed to the COVID that we weren’t able to go faster in the second quarter. But if we look at the industry and other drugs that are in the lipid space, we certainly grew faster than the others and we are encouraged for the future. I just can’t predict how fast we’ll grow.

Thank you.

Your next question comes from the line of Michael Yee with Jefferies. Please proceed with your question.

Hey, good morning, John. Thanks for all the details. 2 straightforward questions. One on the ongoing patent situation, can you just right size for investors. If you win, I think there’s no big change goes back to normal. If it is an adverse outcome, is the thinking in short that there would be limited players at the outset? If not, actually, I think only 1 is approved. And that pricing and capacity is fairly limited. I think that’s the summary of your opening comments. And then the second question is just on Europe, in short, is your comments meant to support a pretty small European infrastructure? I mean, you’re talking about Ireland and whatnot. So, is that the takeaway on Europe that it’s a relatively small infrastructure until – well, until we get to 2021? Thank you.

Hey, Michael. Good morning. Thanks for the questions and just looking at the clock. These, unfortunately, have to be the last questions that we take today as people want to get on with their investment days. With regarding the patent size, clearly, we think that the right answer here should be that we win and we then have the exclusivity until generics could come into the market in 2029. I think that is the right answer. In the event that we were to lose, it’s our view, based upon information available to us that supply for generic companies would be limited. If supply is limited, there’s really not a lot of motivation for them to try to get into a pricing war, and particularly, because we would undoubtedly have better cost efficiencies on the manufacturing side. But if you’ve got limited supply, and it’s difficult to manufacture, why would you sell that limited supply inexpensively. In that scenario, which – provided that there is limited supply we will evaluate our best course when the information becomes available to us, but we would envision that branded VASCEPA would remain substantial for a substantial period of time and we’ll adjust our promotion at that point in time to see whether it should be further increased, maintained or contracted. But I think this is not a typical generic launch. This is not where they can use their existing facilities and plug this product in and have a generic replacement. So we would envision branded VASCEPA being a player for a substantial period of time. With respect to Europe, the product is not yet approved. So we will be building a core team and that core team might be this year, roughly a couple of dozen people over and above the current infrastructure that we have in Europe. And then, as we’re getting into various countries, we would be adding, sales representation in those countries, focusing on the largest countries first, not going to get into great details there. I think in Europe, relative to the United States, patients who are at higher risk for cardiovascular disease tend to, not exclusively, but tend to be proportionally treated more by specialists, typically cardiologists. Whereas in the U.S., the GPs tend to treat a lot of the stent treated patients and they don’t necessarily see cardiologists. So there may be – and we’ll evaluate, this where we’re fine-tuning our plans. There may be opportunities for certain elements of efficiency to capitalize in the targeting of physicians in Europe. That’s a bit different than what we have in the United States. But in the United States, we started off with the targeting the highest potential prescribers and then have expanded and continue to expand beyond that really with the DTC to launch. And we’re just starting to get beyond target positions that we’ve been going after. So there are many others who could be potentially prescribers. In Europe, logical course would be to similarly put together a team that’s appropriately sized to go after the highest potential physicians in terms of education and awareness of VASCEPA, in parallel with the reimbursement efforts. But not to get out over our skis, we don’t need to be putting big teams in place, in countries particularly before you know reimbursement is established and reimbursement will take place on a country-by-country basis. Some are quicker than others. Some allow you to have some access to the market in certain countries before you have reimbursement, but most don’t. So overall, the span will be relatively limited until we have both approvals and reimbursement.

Perfect. Thanks.

Thank you for those questions. Thanks, everybody. I know it’s a long call. We’re not really doing traditional investor meetings these days. So the opportunity to be in front of you is not as frequent as it has been in the non-COVID era. So, given it was mid-year, we thought we’d be relatively comprehensive here today. Hopefully, the comments were helpful to you. We got a lot going on, lot of milestones coming up. We’re optimistic. Just got the right people and the right product to execute. We look forward to providing you updates as we move forward. So thanks again.

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