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Amarin Corporation plc
8/4/2020
Greetings and welcome to the Ameren 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host, Elizabeth 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 the SEPA prescriptions, the SEPA product and licensing revenues, costs, gross margin, and other commercial metrics. Our current plans and expectations regarding spending, including expenditures for promotion of the SEPA, and for purchases of additional supply of the SEPA. Our current expectations regarding the adequacy of our financial resources, our current plans and expectations for product revenue growth, Salesforce productivity and product promotion in light of COVID-19 and the potential for added attention to cardiovascular risk reduction drugs like the SEPA as a result of COVID-19. Our current plans and expectations regarding our appeal of the District Court for SEPA related patent litigation decision to the Federal Circuit and our current plans and expectations related to the potential launch of generic versions of the SEPA by generic companies and by ourselves, including expectations regarding ANDA approvals by the FDA, generic cost effective supply availability, timing, potential levels of damages and ability to recover the SEPA growth if the appeal succeeds. Our current expectations for regulatory reviews outside the United States regarding the SEPA approval. Our goals regarding the timing, scope, and success of international expansion including expectations regarding our ability to launch the SEPA in Europe and our expectations in China for clinical trial results and potential to bridge reduce it results in labeling and promotion of the SEPA through our partner in China. Our current plans and expectations regarding the SEPA 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 the SEPA related to COVID-19 and regarding the results of the EVAPORATE study. These statements are based on information available to us today, August 4th, 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 forelooking 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 Amerincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amerin 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 Amerin website, also in the investor relations section. Making prepared remarks on today's call will be John Therrell, 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 will be over an hour. I now turn the call over to John Tharo, President and Chief Executive Officer of Ameren.
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