Fly Intel: Wall Street's top stories at midday » 12:1805/1205/12/21
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Equity futures extended…
Fly Intel: Top five analyst downgrades » 09:5605/1205/12/21
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Catch up on today's…
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Novavax (NVAX) downgraded to Neutral from Overweight at JPMorgan with analyst Eric Joseph saying there were "several disappointing updates" on the recent earnings call, the most troubling is the "clear challenge" the company still faces in manufacturing its vaccine candidate at large scale. 2. Dollar General (DG) downgraded to Sector Perform from Outperform at RBC Capital with analyst Scot Ciccarelli noting that the company continues to execute at a high level, but an improving employment macro environment could reduce the trade-down activity even as rising food and gas prices pressure their existing customer. 3. Grocery Outlet (GO) downgraded to Hold from Buy at Deutsche Bank and downgraded to Hold from Buy at Craig-Hallum. 4. Jamf Holding (JAMF) downgraded to Neutral from Buy at Goldman Sachs with analyst Rod Hall saying the company reported "solid" Q1 results but the implied second half of 2021 guidance is 2% below forecasts due to uncertainties around the sustainability of educational tailwinds and the pickup of commercial demand. 5. Amarin (AMRN) downgraded to Sell from Neutral at Goldman Sachs with analyst Paul Choi saying generic entrants in the U.S. will limit Vascepa's growth ahead of the European launch. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, Reference Link
Fly Intel: Pre-market Movers » 08:5905/1205/12/21
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Check out this morning's…
Amarin downgraded to Sell from Neutral at Goldman Sachs » 04:5305/1205/12/21
Goldman Sachs analyst…
Goldman Sachs analyst Paul Choi downgraded Amarin to Sell from Neutral with a price target of $5, down from $6. The stock in premarket trading is down 3% to $4.45. Generic entrants in the U.S. will limit Vascepa's growth ahead of the European launch, Choi tells investors in a research note. The analyst sees a "clear need" for Amarin to diversify away from Vascepa. Consensus estimates call for year-over-year growth in Vascepa sales despite the steady utilization of Hikma's generic Vascepa and the pending launch of Dr. Reddy's own generic product, says Choi. He expects both to increasingly erode Vascepa's market share in 2021 and beyond. Physicians overwhelmingly indicate plans to prescribe generic products, particularly given coverage and cost challenges associated with branded Vascepa, says the analyst, citing his conversations with them. Choi sees "increasing urgency" for Amarin to engage in more active business development to develop the pipeline that can be commercial-ready ahead of European loss of exclusivity in the early 2030s.
|Over a week ago|
Piper continues to see 'immense market opportunity' for Amarin in EU » 10:3204/2904/29/21
Piper Sandler analyst…
Piper Sandler analyst Yasmeen Rahimi said she continues to be impressed by Amarin's commercial preparations in the EU and while "the Street is impatient for EU launch," she emphasized that it will take time to obtain market access and negotiate pricing. The analyst, who continues to believe the EU "represents an immense market opportunity" and expresses conviction in Amarin's ability to execute, keeps an Overweight rating and $19 price target on the shares following the company's Q1 report.
Amarin reports Q1 non-GAAP EPS 3c, consensus (5c) » 06:1904/2904/29/21
Reports Q1 revenue…
Reports Q1 revenue $142.2M, consensus $147.1M. "Results in Q1 reflect a mixture of positive accomplishments and continued headwinds, particularly from COVID-19, the effects of which continued to be more persistent than was hoped," stated CEO John Thero. "A clear highlight of the quarter was the broad label for VAZKEPA which is now authorized for marketing in Europe. The opportunity for VAZKEPA in Europe is large and our team in Europe is making tremendous progress. In the United States, while we ended Q1 with some early signs of potential recovery from the effects of COVID-19, such as increased rates of patients new to the brand and more prescribers of VASCEPA, such signs are based on limited data, inconsistent, and vary by geography. (...) As we witness greater evidence that the effects of COVID-19 are receding, we plan to increase what we believe to be our most cost-effective marketing initiatives to continue the launch of this important product for the cardiovascular risk reduction indication that we pulled-back due to COVID-19".
Amarin announces Great Britain marketing authorization for Vazkepa from MHRA » 10:5704/2204/22/21
Amarin Corporation plc…
Amarin Corporation plc announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, has granted a Marketing Authorization for Vazkepa as a treatment to reduce the risk of cardiovascular events in high cardiovascular risk statin-treated adult patients who have elevated triglycerides and either established cardiovascular disease or diabetes, and at least one additional cardiovascular risk factor. "The Great Britain Marketing Authorization for Vazkepa applies to England, Scotland and Wales. Under the Brexit Northern Ireland agreement, the European centralized marketing authorization for the European Union covers Northern Ireland," Amarin said.
Amarin presents new analyses of EVAPORATE study » 16:0604/1804/18/21
Amarin announced that…
Amarin announced that further analyses from the Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: EVAPORATE Trial were presented as Late-Breaking Science at European Society of Cardiology Preventive Cardiology 2021, the Annual Congress of the European Association of Preventive Cardiology, on April 17. As previously reported and published in the European Heart Journal, VASCEPA demonstrated significant, 17% regression of low attenuation plaque volume on multidetector computed tomography compared with placebo over 18 months. The Effect of Icosapent Ethyl on Changes in Coronary Plaque Morphology: EVAPORATE analyses presented at ESC Preventive Cardiology 2021 demonstrated that with administration of 4 g/day of VASCEPA on top of statin therapy, there was an observed change in plaque stability occurring at 9 months and sustained through 18 months. Of the 80 patients that were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial, 55 patients had images that were able to be utilized for the histology-validated software. The EVAPORATE plaque morphology study used ElucidVivo, the first FDA-cleared analysis for specific tissue characterization using histopathologic correlates to assess plaque morphology characteristics, including Lipid Rich Necrotic Core, fibrous cap thickness, and intraplaque hemorrhage. Whereas with placebo LRNC increased and cap thickness decreased, both indicative of moving to a less stable phenotype, with icosapent ethyl there was a measured LRNC decrease and cap thickness increase, indicative of moving to a more stable phenotype. The primary limitation of this single coronary plaque study as identified by its investigators is its small sample size. More study is needed to more fully understand the effects of VASCEPA on coronary plaque to determine the relationship, if any, of such plaque effects on cardiovascular risk reduction.
|Over a month ago|
New CEO at Amarin to facilitate continued growth, says Piper Sandler » 20:5304/1204/12/21
Piper Sandler analyst…
Piper Sandler analyst Yasmeen Rahimi keeps her Overweight rating and $19 price target on Amarin after the company announced that Karim Mikhail would succeed John Thero as CEO later this year. The Street was surprised by the announcement, the analyst tells investors in a research note, but she believes that his deep commercial expertise will facilitate Amarin's continued growth, especially ahead of VAZKEPA's E.U. launch in Q3 of this year.
Amarin CEO John Thero to retire, Karim Mikhail to succeed » 16:3204/1204/12/21
Amarin announced that…
Amarin announced that John Thero has informed the board of directors of his plan to retire as president and CEO, effective August 1. He will also step down from the board at that time. The board has appointed Karim Mikhail, Amarin's senior vice president and head of commercial for Europe, to succeed Thero as the company's next president and CEO. Mikhail will join the board upon his effective date. Thero will continue to provide his guidance and expertise to the company in an advisory capacity through the end of 2021. Mikhail joined Amarin in 2020 from THEODON, a global commercial strategy consultancy he founded in 2018.