Amarin Corporation plc

Greetings. Welcome to Ameren Corporation's conference call to discuss its preliminary first quarter financial results and operational updates. This conference call is being recorded today, April 13, 2020. I would like to turn the conference over to Elizabeth Schwartz, Senior Director of Investor Relations of Ameren. Thank you. You may begin.

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, that are not limited to, our current expectations regarding our commercial and financial performance, including levels of VSIPA prescriptions, VSIPA product and licensing revenues, costs and other commercial metrics, gross margin, expenditures such as for the purchase of additional supply of VSIPA, and the adequacy of our financial resources. Our current plans and expectations for product revenue growth and product promotion in light of COVID-19 and any potential for added cardiovascular risk attention to the SEPA as a result of COVID-19. Our current plans and expectations regarding appealing the district court the SEPA related patent litigation decision to the federal court and the current plans and expectations for potential launch of a generic version of the SEPA by generic companies and by ourselves, including expectations regarding and approvals by the FDA, generic cost-effective supply availability, timing, potential levels of damages, and ability to recover VSEPA growth if the appeal succeeds. Our current expectations for regulatory reviews outside the United States regarding VSEPA approval and regulatory reviews inside the United States regarding consumer promotion and related timing thereof. our expectations regarding Salesforce productivity, our goals regarding the timing, scope, and success of international expansion, including expectations regarding our ability to launch with SIPA in Europe directly through a potential partner, our current plans for commercial expansion in the United States, our current plans for spending, and our expectations regarding the use and adequacy of our resources. These statements are based on information available to us today, April 13, 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 under 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 31st, 2019, as well as our Forms 8-K filed subsequent to our Form 10-K. These documents have been filed with the SEC and are available through the investor relations section of our website at Amerincorp.com. We encourage everyone to read these documents. This call is intended for investors in Ameren and is not intended to promote the use of the SEPA outside its approved indication. An archive of this call will be posted on the Ameren website, also in the investors relations section. I will now turn the call over to John Tharo, President and Chief Executive Officer of Ameren.

Hello, everybody. Thank you for joining us today. During this call, we intend to cover a variety of topics, including and update on the launch of the SIPA in the United States for its relatively new cardiovascular risk reduction indication. Our end of situations and plans to vigorously pursue reversal of the district court decision and continued the SIPA sales growth, the impact of COVID-19 on our operations and expiration being considered for potential use of the SIPA to help COVID-19 patients at high cardiovascular risk. Lastly, we'll include some updates on the large international opportunities for the CIPA. First, I want to express my gratitude for many investors who, despite losing money after the district courts, the prize negative decision on our and the litigation reached out to Ameren expressing messages of support and offering constructive suggestions. While we cannot respond directly to all such messages, please know that they each are reviewed thoughtfully and that we appreciate all constructive advice. One purpose of this call is to share with you key elements of our current thinking regarding Ameren's strategy and future. As I am sure you appreciate, we don't have all of the answers to the continually changing landscape brought on by COVID-19 and the end of litigation decision. In addition, there are, of course, tactical reasons that prevent us from detailing on this publicly available call our planned appeal arguments and related commercial strategies rather than having them conveyed through court proceedings and in the field. I intend to cover significant details on this call. I expect that my comments will consume more than 30 minutes. To set the tone for this call, Ameren has confidence that we will create significant shareholder value. At this point, our intention is to provide updates on matters which we understand to be the most important to investors. As noted in our call announcement, We have not scheduled a Q&A period at the end of this conference call. In the ordinary course, in conjunction with our Q1 results call, we will provide additional financial and operational updates and we plan to take questions at that time. I start by giving a preview of Q1 2020 results. We ended March 2020 with more than $620 million in cash and short-term investments and less than $50 million remaining due on our royalty-like debt instrument, such that we are well-capitalized and get to cash flow positivity based upon our current resources. The launch of the SEPA in 2020 got off to a good start in Q1 as the first and only drug for reducing persistent cardiovascular risk as per the new indication approved by the FDA near the end of 2019. We hired a terrific sales team and expanded our managed care field team. We trained a well-respected group of physicians to help support medical education. We advanced our proposed consumer promotion with the FDA for our previously intended DTC program launch in the coming months. and we witnessed prescription levels grow in the first quarter to levels which exceeded our Q1 expectations. Regarding Q1 2020 net total revenue, our preliminary estimate is that it totaled approximately $150 million with potential to be modestly higher when finalized with the amounts for international revenue including revenue from Canada Thank you for joining us. that we reported in the first quarter of 2019. This revenue growth was driven by increased prescription levels for Bacepa. Based upon the preliminary information available to us at this time, it appears that we witnessed increased prescription levels both from doctors who previously prescribed Bacepa as well as from new writers. And some of our greatest areas of growth included areas of the United States where we did not have sales representatives a year ago. As you know, we recently increased the size of our US sales team to 800 sales representatives plus their managers from the 400 we had in place for most of 2019. As mentioned earlier, if the sales representatives we hired as part of our recent expansion become as rapidly productive as did the sales representatives we hired last year. The 2020 revenue guidance range that we provided at the start of 2020 which was a target range of $650 to $700 million was likely conservative. Based on review of Q1 results during which revenue growth was coming on particularly strong in the month of March, We were considering increasing our revenue guidance for the year. This, of course, was before the model adjustments we have been forced to consider resulting from the hopefully temporary market impact of COVID-19 and the uncertainties related to the court ruling in our patent litigation. I'll revisit the topic of financial guidance in a moment. Before going there, I need to acknowledge that many unknowns exist due to the challenges and potential opportunities created by COVID-19 and due to the patent litigation ruling in our planned appeal. The Ameren team has overcome numerous challenges in the past. Our people are highly motivated to help improve patient care. If we are not successful, too many patients will likely never benefit from the SEPA because both product related education and further product-related research and development won't be funded or championed. We have come too far to stop fighting now. We took on product development in the marine, anchor and reducer studies and against the expectations of the masses, we showed unprecedented results. We won past legal battles on numerous topics including new chemical entity status, and the First Amendment Communication Rights. We have smart and dedicated people who are working as a team. We don't like being told that we can't overcome an obstacle when the obstacle puts patients at risk. Moreover, we are all shareholders of Ameren and we intend to continue to fight vigorously for what we believe is right and best. In the aftermath of both the COVID-19 In the ANDA court ruling, I am proud to witness the team at Ameren aggressively seeking out solutions and finding ways to advance our important priorities. Regarding the district court ruling in the ANDA litigation, as previously communicated, we were surprised and disappointed that the court determined that patent upon which we relied to build our business should be considered invalid based upon arguments of perceived obviousness. In doing so, in my view, the court decision not only did not fully appreciate the importance of vasepa as a unique and valuable breakthrough therapy for which I believe there is considerable evidence, but it also overturned the decision of the U.S. Patent Office, which earlier had granted our patents After thorough review of prior art and after its own consideration of obviousness, we understand that it is difficult to look back at the SEPA product development, the genesis of which commenced over a decade ago, and pass judgment on what was understood by people at the time. However, I was part of Ameren at that time. and I can assure you that investors and experts did not think that what Ameren was pursuing was obvious. For example, I recall at that time that Glaxo was looking for a next generation product for Levesa. Based upon my recollection of communications with them at the time, they didn't expect to find that solution in pure EPA. Rather, they were like other big pharma companies that had dismissed omega-3s as a solution. Big pharma companies at that time, to the extent that they were focusing in on cardiovascular disease, were focusing in on statins, CETP inhibitors, making niacin better tolerated and on phenofibrate, not on treating severely high triglyceride levels. Furthermore, as a reminder, The world was in a recession in that timeframe. Few new product development initiatives were being funded, and when they were funded, it was based upon well-vetted scientific insight. Ameren completed one of the largest healthcare financings in that timeframe because of its scientific insights. We have shown repeatedly over the past decade that the scientific aspects behind omega-3s Lipid management and cardiovascular care are each complex. Perhaps the elegance of our solution today makes it look easy in hindsight, but that was not the case at the time. We understand that the science is complex and that the presentation of such materials in a court setting can be challenging. It is not my intention in these comments to show disrespect for the judge. A decade ago, had the science been understood by others the way that it was understood by Ameren, GSK likely would have found a replacement for Levesa in an EPA only drug. And or Epidel, the product used in Jell-Its, would have been developed in other populations and perhaps found use globally. and or AstraZeneca. The NIH and the British Heart Foundation would not have funded large outcome studies of omega-3 mixtures. Heck, just last month, a lead investigator who participated in AstraZeneca's strength trial had data from his lab presented showing unique effects of EPA compared to other omega-3s. Such insights are important. However, Regarding timing, those observations in 2020 came nearly a decade after we filed patents that speak to the uniqueness of the SEPA and its active ingredient, occlusivant ethyl, based upon pure and stable EPA. When we started the marine trial, people were worried that we were allowing statin treated patients into the study because they had not been studied with earlier generation triglyceride lowering drugs. and they worried that the triglyceride lowering effects of vesipa would be mitigated by the triglyceride lowering effects of statin therapy. Nonetheless, we were insistent on treating patients who were treated to the then current standards of care. The marine study was, as you know, very successful. When the results of the marine study became known, I recall the investigators marveling at the triglyceride lowering effect without an increase in LDL cholesterol and how different this was than other therapies. These were reactions by leading physicians. For the Ameren scientific team, the results were gratifying as they saw their insights demonstrated in a statistically significant trial, the design of which had been completed under a special protocol assessment agreement with the FDA. Recall that successful marine study results were needed by the FDA as support for the indication sought in the ANCHOR trial and for getting to the REDUCES study, all of which was outlined with the FDA more than a decade ago. I recognize that it is difficult for people to go back in time to do such analysis. For these and other reasons, I do not believe that the US Patent Office should have been overruled in assessing that the patents for BSEPA were not obvious. Hindsight is, unfortunately, a power force in the human mind. Much that is not obvious at a point in time can then appear obvious after it is discovered. The appeal process likely won't focus on much of the content which I just expressed and therefore such arguments matter little except as to provide you with some context and support for our broader belief that our patents should have been upheld as inventive and not obvious. Rather than re-hearing the case, the appeal will focus on arguments of a more legal nature and important factual errors. The aim of an appeal is to persuade through legal argument a panel of three specialized federal court judges that the end of decision should be overturned or reconsidered when the law is applied properly and factual errors are corrected. Accordingly, please do not expect that appeals are openings to retry the case. Please do not expect that every element that you may think is wrong in the judge's decision will be appealed. That is not the nature of an appeal in this setting. For success, we need to effectively persuade the federal judges that the district court opinion is wrong based upon errors of law and fact that bear on its opinion. We believe that we have numerous arguments that will contribute to a strong, substantive appeal. Many of you have expressed to us examples of arguments that go to points that could be argued on appeal. At this time, we are not going to communicate which arguments will be emphasized. When our appeal is submitted, likely in early May, such arguments will be public. We believe our outside counsel in the district court matter made a convincing case. all experienced independent commentators that took a serious look at the record agree the trial should have resulted in a judgment for Ameren. Looking forward, we have determined that the importance of this case on appeal calls for the addition to the team of a fresh perspective on the record. The nature of arguing an appeal in this field is specialized. and we have accordingly added to our legal team a new lead counsel for this matter who like our trial counsel is a recognized leader in the field and has won cases of this nature at the federal circuit. Our new lead counsel will work with our in-house team and the team that argued the matter in the district court. We believe our team going forward is well situated to make the most of the case and we believe we're favorably positioned to put forward a strong case on appeal. Our aim is to expedite the appeal proceedings towards a hearing and judgment as soon as possible. We are aiming for the matter to be heard in oral argument in the summer after briefings are completed to the judgment as soon as possible thereafter. We can and are working to expedite, but we do not control the court schedule. However, we hope to have more details on timing the briefing schedule over the next week or two. When substantive briefs are filed with the Federal Circuit for this appeal, they will become publicly available through PACER, the internet-based docket publication platform. Based on actions of the generic companies after the court testimony in Nevada, I doubt that they thought that they won the litigation. The uniqueness and inventive nature of the SEPA has been well recognized for years, as was well documented in the US Patent Office. There was the unanimous view of those lawyers and analysts reporting on the matter that Amrit had made a winning case at trial. The uniqueness of BSEPA was further evidenced by the success of the REDUCE-A study and by the early stopping of the competitive study strength due to its low likelihood of demonstrating benefits and to numerous accolades for BSEPA from medical societies and key opinion leaders. In most such situations where generic companies win at the district level and there is a reasonable basis for a reversal on appeal, they wait for completion of the appeal before launching a generic product. While we believe that may be the likely result here, we cannot be sure that one or more of the generic companies won't be daring and launch if they get FDA approval and can launch during the appeal process. If such generic companies get their and is approved by the FDA, have qualified supply and elect to launch during the appeal process they do so at risk that we will win the appeal given both the nature of the appeal and the arguments we intend to make and reflecting on the potential size of the damages which could be imposed on them if we prevail in the appeal their launching at risk would be surprising nonetheless We intend to be prepared for such an unlikely circumstance. Damage awards, if they elect to launch and we prevail on the appeal, could be very significant. If we are in a position of seeking damages from generics, we of course will seek all we can, including at very least the full amount of lost profits available to us. Our intention is to fight vigorously on the appeal and assuming we win, to fight vigorously for compensation for damages if the generic launch occurs by one or more generic companies. The generic companies also know by now that Ameren has spent large amounts of resources over years to develop cost-effective supply capacity for global sales and that, as Vesipa is our only product, We will seek to maximize this global opportunity for Ameren. They should also know that Ameren could launch its own authorized generic product. The tradeoff for launching a generic product, whether that generic product is launched in parallel or with a branded product or in place of a branded product, is that the generic product model does not provide for product related education and promotion. Typically, generic products are launched near the end of a product lifecycle. It has been argued by some that it is good for a generic product to be launched in an established market where the need for education is low if the generic product is inexpensive. However, the price of vasepa has been assessed to be cost effective by many of the harshest critics of drug pricing. Given the relatively high cost of producing vasepa, and the relatively low current price of vesipa, it is unlikely that the price of a generic version of vesipa will be much lower, if lower at all, than the net price of vesipa currently. Moreover, if a generic vesipa is launched soon, it will be launched at what is effectively the start of vesipa's life cycle for cardiovascular risk reduction in the United States. such a launch would stifle the opportunity for vesipa to benefit the patient population, which has been the target of vesipa development for more than a decade. I recognize that there is a general societal perspective that generic drugs are good, but I am confident that many people on this call may recognize that many generic drugs are expensive and that they are many examples of an introduction of generic drugs, which results in less market education, less product development, and often less use of the drug. We have heard from various physicians who learned of the District Court decision. They expressed to us that they are worried that the market won't be properly educated regarding BSEPA. They recognize that while they know about BSEPA, Most healthcare professionals still have little knowledge of the SEPA and that consumers have even less knowledge. Many of them have been urging us to increase educational efforts as we were planning to do, assuming that, as expected, the FDA approves our consumer promotion plans, which are currently under review with expected approval before the end of June. While the courts may elect to not consider Thank you very much. of Education about the drug's benefits. In addition, if this court decision is not reversed following appeal, the undermining of the SEPA's path to success will likely further erode the rate of development of products for chronic ailments like cardiovascular disease as so many developers will observe that Ameren overcame great obstacles to develop the SEPA only to have the opportunity thrown away before any profit was realized and before many patients might benefit. In our case, the launch of the SEPA has just begun to physicians with much further education plan and a consumer education program which is still undergoing FDA review for what was intended to be a launch later this year. Just last month, data presented at the 2020 annual scientific session of the American College of Cardiology by Nathan Wong et al, showed that Vaseepa, assuming that the market is educated and Vaseepa becomes broadly used, could potentially prevent more than 70,000 cardiovascular events per year. Before PICMA or Dr. Reddy's can launch a generic version of Vaseepa, they need to get their end as approved by the FDA. At this stage, Teva cannot launch a generic version of Vaseepa unless it gets ended approval by the FDA and a generic version of the SEPA is launched and we don't obtain an injunction within 60 days. It would otherwise need to wait until August 2029 unless we lose our case in the Federal Circuit. The timing of end approval of generic versions of the SEPA is unknown. Adding uncertainty is the impact of COVID-19 on FDA inspections of manufacturing facilities. We do not know if such facilities for HICMA or Dr. Reddy's were previously inspected or not by the FDA, as the FDA has curtailed site visits due to COVID-19. Their ANDAs were filed in 2016, but they are not yet FDA approved. Most likely, the FDA either didn't take up the review of the ANDAs because the product couldn't be launched due to regulatory exclusivity, or the FDA took up their review and found issues. The manufacture of vasepa is not easy. Ameren, in concert with its manufacturing partners, has been successful in consistently producing vasepa for commercial use since 2012. While our suppliers are reliable today, each API supplier we added during this growth period had to overcome setbacks, often with Ameri's help and investment as they advanced from pilot scale to commercial scale and as they worked with us to pioneer efficiencies and cost savings in their facilities dedicated to production of BSEPA API. The challenges of BSEPA manufacturing do not stop with its purity. Such challenges extend to its stability, including important steps in its isolation, encapsulation, and packaging. If the active ingredient is allowed to oxidize, its clinical effect may be impaired. For Bacepa, because of the importance of product stability, we successfully tested the product for four years in capsule form. Achieving this result required extensive effort and focus. In qualifying new suppliers, proving long-term stability has been critical. Based upon the various publications of data regarding the fragile nature of EPA, any potential manufacturer of API for generic companies will have to consider how to best address these challenges, recognizing that compromising could result in patients not getting the drug benefits they deserve. Moreover, creating manufacturing supply is time-consuming and expensive. If the generic companies don't already have established capacity for BSEPA at commercial scale and we are not aware that they have such proven commercial scale capacity, they will need to establish such capacity just as Ameren established such capacity. In order to do this at substantial scale, for example, to be able to support $100 million or more in revenue. This growth and qualification is likely to be expensive and can take years to accomplish. In Ameren's experience, many potential suppliers tried but failed in advancing from pilot scale to commercial scale within the high quality requirements of ASEPA. In order to achieve high quality potential shortcuts should be avoided. For example, it is not consistent with good manufacturing practices to ship Epidil API to Visipa API as the products are not identical and the drug master files are different. I mention this as an example of a potential shortcut, although we are not aware of a glut of extra Epidil capacity. Perhaps a small amount can be identified but can't be brought for the U.S. as a generic without FDA review. In any event, our view is that this would not be at a volume approaching the capacity needed to support retailer contracts for a generic version of a broadly used product like BOSIPA where this year we are purchasing more than 1,000 metric tons of API. We have heard from various suppliers that they have been approached regarding supplying API for generic use. These suppliers informed us that they have turned down such approaches for various reasons, including that they don't have excess capacity. We don't have perfect visibility of the dynamics that could contribute to the timing and capacity of a generic launch, but we either have plans in place already or we are rapidly putting plans in place for a range of possible scenarios. We believe that there is an opportunity for shareholders to benefit under the most likely of these scenarios. Let me now turn the discussion to coronavirus. COVID-19 has created both challenges and potential opportunities for expanded use of the SEPA. As expressed earlier, our Q1 growth with the SEPA exceeded our expectations and appeared to be on a strong trajectory for further growth. Following the environment of social distancing created by COVID-19, the outreach of our sales team to healthcare professionals has been more challenging and moreover, routine visits from patients to physicians have been curtailed. And some of the geographies which are the most impacted by COVID-19 such as areas of New York and California are areas where Visipa was first launched and historically strongest since Visipa use. Our sales team is finding creative and professional ways to maintain contact with many healthcare professionals. And on a year-over-year basis, we are continuing to see significant increases in Visipa shipments and TRX levels over the same period from a year ago. However, as is true for other drugs, new patient starts appear to have slowed in recent weeks. We are continuing to find new ways to reach out to healthcare professionals. That which seemed odd a few weeks ago is becoming the norm today. And we have plans ready for resuming direct sales calls when the company is ready for such safe in-person interactions, likely rolled out on a regional basis. In spite of COVID-19, we have continued to interact with managed care organizations and PBMs. We're happy to report that insurance coverage for Vespa improved further at the start of April. You may recall in an earlier investor call that we spoke of multiple Blue Cross Blue Shield plans improving coverage for VSIPA in three states during Q1. Subsequently, effective April 1, coverage for VSIPA was moved to preferred brand status under Blue's plans in 14 additional states. These are states where Blue's plans are managed by Anthem. Previously, this class of drugs including LaVesa in both branded and generic form was not covered by Anthem plans as Anthem is historically a high control plan. The Anthem Blues plans tend to be the largest or second largest insurers in the states where they compete. Our sales team is excited about introducing this expanded coverage to physicians in these 14 states. Such pull through via physicians won't be immediate, but it will help. In addition, while not as large a number of patients covered as the coverage improvements via Anthem, there have been two national plans under the CVS family of managed care plans where Vesepa was not covered. As of April 1st, those two plans now cover Vesepa as a preferred brand. With these changes, VSIPA now has preferred brand coverage in 100% of the lives under CVS national commercial formularies. As a reminder, a preferred brand means not only is the product on formulary, but it also has the lowest copay for branded products. The medical need for VSIPA remains high. In the current environment, We expect to have continued year-over-year sales growth despite the impact of COVID-19. It is far too early to accurately quantify the impact of COVID-19 on revenue levels. We will revisit our revenue guidance for 2020 after we are able to resume direct in-person sales calls with physicians. People with cardiovascular risk factors appear to be at greater risk for COVID-19. We, together with leading physicians on multiple continents of the world, are reviewing whether there are opportunities for vesipa to be used in acute or chronic settings to potentially mitigate heightened cardiovascular risks associated with COVID-19. Whether or not such efforts will succeed are not yet known. nor do we yet know the extent of such potential investigation. However, we feel it is incumbent to try to help. Currently, such work is being evaluated based upon what is already known about FACIPA, which is that it lowers cardiovascular risk in high-risk patients. If new data or other information presents itself regarding potential benefits of using FACIPA in COVID-19 patients, We and or our medical collaborators will make this known. I promised that we'd also talk about international opportunities for Bacepa. Cardiovascular disease remains the number one cause of death in the industrialized world, regardless of how large a brand Bacepa becomes in the U.S. The end of court decision in the US should not impact the multi billion dollar potential opportunities for the SIPA outside the United States. As a reminder, the our partner in China, we have a clinical trial for the SIPA, which should report results later this year. We are informed that the impact of COVID-19 should not have a significant impact on the clinical results in China, or on the timing of such results. Assuming clinical trial success, this will position BSEPA to be first in class in China. For Europe, we continue to pursue a parallel process of evaluating whether to launch BSEPA on our own in select countries and partnering in other countries, or to enter into a pan-European partnership for the launch of BSEPA. As previously reported, in Q4 2019, Our regulatory submission for VSIPA in Europe was accepted for review by the EMA. We seek a cardiovascular risk reduction indication in Europe. We intentionally did not go for the less valuable triglyceride lowering indication in Europe because we believe that reimbursement will be stronger based upon a cardiovascular risk reduction indication. In fact, based on the unprecedented results of reduce it, We believe that the net price of Vaseepa in Europe should be at least as high as the net price of Vaseepa in the United States because Vaseepa was launched in the United States as a triglyceride lowering agent in a market with generic products and without cardiovascular outcomes data. Our expectation is that Vaseepa will be approved near the end of this year for launch in Europe. Regarding partnering, For reasons previously discussed, we waited to advance the partnering evaluation process for Europe until after we had a preliminary feedback from EMA regarding its questions pertaining to our regulatory submission. We have received such regulatory review feedback, the questions from which are somewhat analogous to the questions we received from Health Canada during their review. Pursuant to this added confidence and leverage, We are in the early stages of reviewing potential partners for Europe. Europe presents a large market opportunity for VSIPA. We have been informed via the regulatory process that VSIPA should qualify for 10 to 11 years of regulatory exclusivity in Europe. And we expect our reduce it results drive patent to extend the branded life of VSIPA in Europe until mid 2033. While we have received considerable input from investors regarding whether it is best to go direct in Europe or best to partner in Europe, we believe it is best to see what proposals the partnering process produces and then to make a decision most likely in the third quarter of this year. As a reminder of the large unmet medical need in Europe, there are more than 80 million people in Europe living with cardiovascular disease. This number is growing with approximately 11 million new cases of cardiovascular disease added each year in EU countries. Cardiovascular disease results in approximately 1.8 million deaths each year in Europe on top of a large number of debilitating events such as strokes and heart attacks resulting from cardiovascular disease. Caring for cardiovascular disease in Europe is expensive. with annual spending estimated to currently exceed 200 billion euro annually. These data, combined with clinical results from BSEPA, likely contributed to the medical guidelines issued by the European Society of Cardiology and the European Atherosclerosis Society recommending use of acosabonethyl. Numerous key opinion leaders in Europe remain active in urging for the approval of BSEPA in Europe helped improve care for their patients. With regard to spending levels, while we are well capitalized, we seek to be judicious. We operated most of last year at a cash flow neutral to modestly cash flow positive level before increasing our promotional spending in conjunction with the CIPA approval by the FDA at the end of 2019. We had intended for 2020 to be a year of substantial investment in market development for long-term benefit. In light of the U.S. patent litigation, we are reducing our planned spending levels in 2020. We are in the process of evaluating all of our spending commitments and priorities. Our spending priorities emphasize activities which advance the SEPA U.S. growth in the near term which advance the SEPA internationally and which increase our likelihood of success upon appeal in the US patent litigation matter. As part of this, we want to be prepared to accelerate our US launch further if and when we win on the appeal. In pursuing these three areas of emphasis, it is our intention to pull back on certain areas of spending which are longer term focused. For example, we had intended to invest significantly in patient and consumer education and promotion. However, such investment is expensive and tends to have a delayed benefit making it difficult to justify unless and until we win our patent related appeal. We intend to continue forward with our direct sales efforts as historically such efforts have rapidly paid for themselves. We'll have more to say regarding our financial outlook after we get more clarity on the impact of COVID-19 on revenues and on whether or not generic product is launched prior to conclusion of the appeal process. Overall, Ameri is confident that we will find pathways to create value for its shareholders from our operations in the United States and internationally. We have overcome greater challenges in the past. Ameren is well capitalized. Our revenues grew over 100% in Q1 of 2020 compared to last year. We have great people. We have a unique product with unprecedented clinical results and we are addressing a potentially huge market need. Although we don't yet have all the answers, if we don't lose sight of our objectives, We will find ways to succeed. With that we conclude our prepared remarks. We look forward to updating you on our future progress. Thank you for your interest and support.