AMRN Trade on Nov 5, 2019 09:36 from Cklamb: Tradervue User Stock Trades.

AMRN
Intraday Fundamentals
• Key Amarin achievements since its last quarterly report include:
• Record total revenue: Reported total revenue of $112.4 million and $286.5 million for the three and nine months ended September 30, 2019, respectively, representing increases of 103% and 89%, respectively, over the corresponding periods of the prior year. The total revenue reported for the first nine months of 2019 exceeded the full-year results reported for 2018.

• Record prescriptions: Growth in net product revenue was supported by increased prescription levels of Vascepa® (icosapent ethyl) capsules. The increased prescription levels reflect both a higher number of Vascepa prescribers and an increase in the average prescriptions per prescriber.

• Preparing for anticipated label expansion: Assuming that, on or before the previously announced December 28, 2019 PDUFA date, Vascepa’s label will be expanded to reflect cardiovascular risk reduction as demonstrated in the REDUCE-IT® cardiovascular outcomes study, Amarin is taking broad steps to prepare for commercialization of Vascepa as the first therapy to address this important unmet medical need, including preparation for increased education of healthcare professionals and patients. Furthermore, to support FDA’s approval of Vascepa for this expanded indication, Amarin has prepared for, and looks forward to, the FDA’s advisory committee meeting scheduled for November 14, 2019.

• International regulatory activities on track: Amarin continues to target making its submission, before the end of 2019, seeking regulatory approval of Vascepa in Europe. Regulatory review of Vascepa in Canada continues to progress through Amarin’s commercial partner in Canada with approval anticipated near the end of 2019 (late 2019 or early 2020).

Prescription Growth
• Based on monthly compilations of data provided by third parties, Symphony Health and IQVIA, the estimated number of normalized total Vascepa prescriptions for the three months ended September 30, 2019 were approximately 865,000 and 787,000, respectively, compared to 458,000 and 417,000, respectively, in the three months ended September 30, 2018. These estimates reflect increases of 89% in the third quarter of 2019 over the same period of 2018.
• The increase in prescriptions occurred broadly across the United States with the fastest percentage growth reported to come from cardiologists and endocrinologists and with the largest overall volume growth coming from general practitioners as there are many more general practitioners than specialists in the United States. The growth came from areas supported by Amarin’s legacy sales representatives and from faster than expected productivity of new sales representatives added in early 2019. It is this increased productivity of new sales representatives, together with feedback from physicians, that convinced Amarin that the size of its sales force should be doubled from 400 sales representatives (the level at which the company has operated for most of 2019) to 800 sales representatives in preparation for the launch of Vascepa for cardiovascular risk reduction at the start of 2020, assuming FDA approval.
• Regulatory Schedule in the United States

• December 28, 2019 is the Prescription Drug User Fee Act (PDUFA) target date for action on Amarin’s supplemental New Drug Application (sNDA) seeking approval of Vascepa as the first drug approved for cardiovascular risk reduction in the patient population studied in REDUCE-IT. An FDA advisory committee meeting pertaining to the sNDA for Vascepa is scheduled to be held on November 14, 2019 at the FDA’s offices in White Oak, Maryland. The FDA makes information available regarding this advisory meeting at

. Holding an advisory committee meeting in conjunction with its evaluation of a new drug is not uncommon for the FDA, particularly when the indication being sought is first in class for a potentially large patient population as is true for the sNDA under review for Vascepa.
• As is the usual protocol, briefing books will be used for preparation of advisory committee panel members with information related to Vascepa, the related science and questions that the advisory committee panel members will be asked to vote on at the meeting. The briefing books typically are made public two days before the commencement of the advisory committee meeting. We expect this process to be no different for the Vascepa-related advisory committee meeting on November 14, 2019. Advisory committee panel members may ask their own questions regardless of whether such questions are covered in the briefing books or not.
• The results of the REDUCE-IT study have been published in The New England Journal of Medicine and the Journal of the American College of Cardiology. And, as noted above, leading medical societies and other groups support the use of Vascepa to cost effectively address cardiovascular risk in studied at risk patients beyond statin therapy. Based on data, if all patients in the United States who have risk profiles similar to what was studied in REDUCE-IT were to take Vascepa, this could lower the number of major adverse cardiovascular events in the United States by approximately 150,000 to 450,000 per year.
• Amarin looks forward to the advisory committee meeting on November 14, 2019 as an opportunity to further illuminate the results of the REDUCE-IT study and to provide further education on why Vascepa is a unique drug that should be approved for cardiovascular risk reduction which would position the drug to potentially help millions of patients. Amarin is appreciative of the approximately 100 letters which have been sent to the FDA from health care professionals, patients and others in support of prompt approval of Vascepa for cardiovascular risk reduction. The letters can be viewed with this link: .
• Excluding non-cash gains or losses for stock-based compensation, non-GAAP adjusted net income was $4.5 million and non-GAAP adjusted net loss was $7.0 million for the three and nine months ended September 30, 2019, respectively, or non-GAAP adjusted basic and diluted earnings per share of $0.01 and loss per share of $0.02, respectively, compared to non-GAAP adjusted net loss of $17.8 million and $68.7 million for the corresponding periods of 2018, respectively, or non-GAAP adjusted basic and diluted loss per share of $0.06 and $0.24, respectively.
Cash and cash equivalents were $673.2 million as of September 30, 2019. Net accounts receivable were $103.6 million ($133.5 million in gross accounts receivable before allowances and reserves) as of September 30, 2019.
• Net cash flows, excluding net proceeds from the equity offering completed in the third quarter of 2019, was positive $11.3 million and negative $16.1 million for the three and nine month periods ended September 30, 2019, respectively.
• As of September 30, 2019, Amarin had approximately 357.2 million American Depository Shares (ADSs) and ordinary shares outstanding, 28.9 million common share equivalents of Series A Convertible Preferred Shares outstanding and approximately 16.3 million equivalent shares underlying stock options at a weighted-average exercise price of $6.21, as well as 9.4 million equivalent shares underlying restricted or deferred stock units
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Technicals
ADV 6.44m RVOL 1.10 ATR .63 BETA 1.15 Short 29.5% Inst Own 46.80%
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Trading Strategy
• Long bias on this
• Look to work the gap fill at 17.50 and the 50% at 17.80
• If this hits 17.50 for a full gap fill expect it push into the 17.40 or 17.30 before taking this long
• If it bounces hard off 17.50 in a v shape manner, scalp into this and look for it to start trending after and pull back into 17.60ish
Reading the Tape
The tape was fairly easy to follow on this as you could see the sellers overhead all morning and the buyers underneath all afternoon