![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Thursday, June 20, 2019 12:24:38 PM
Not according to JT based on the Jefferies note:
Company continues to be bullish on accelerating market penetration and sales over the coming quarters. Co has noted the window for FDA to confirm any AdComm panel is narrowing, given priority review and PDUFA for Sep 28th. We think no panel and stock moves higher for straighter shot towards clean approval. In terms of patent litigation, a court date is set for Jan 2020....we think if any settlement comes, stock moves quickly higher towards $25+.
Insights
YTD the stock is up +42% (vs XBI +21%) as evidence of Vascepa's sales execution and potential (eg weekly script numbers) - continues mounting every week. Vascepa scripts recently hit record highs per third party data and even accelerated to +20% Q/Q vs +15% last quarter...all of this despite any formal FDA label expansion yet. Outside of Vascepa, the company has two key events/overhangs that could push stock higher towards $25+: (1) potential no AdComm could convince market that FDA has no major topics of debate and takes any headline or unpredictable panel risk off the table, and (2) clarity around generic filers as this uncertainty and patent decision in H1:20 makes it tough to own the stock for some investors, in our view. Hence for the stock, we think it goes higher on potential strong Q2 and possible guidance raise, pot'l no Adcom confirmation, and if they could secure a patent settlement by early 2020...so overall trend for stock is likely higher into year end....Trading risks seem to be: growing expectations on Q2 and risk/reward on prior quarters despite beats, panel is possible and stock pulls back despite panel highly likely to be OK, investor perception of further growing salesforce from 400 to 600+ at YE and upcoming DTC spend, no certainty on any litigation outcome.
Thus far, despite passing Day 60-74, FDA has not indicated whether it plans to hold an AdCom. We note there was no AdCom for the PCSK9 CV outcomes label expansion and AMGN was easily approved on time for their Priority Review too. Hence it's possible AMRN may not have a panel as there aren't any major debates here. We think 60% probability no panel and removes short-term headline risks. Mgmt commentary seems to be balanced noting FDA could always hold one to air public discussion, discuss differences of Vascepa vs other fish oils, and any relevance or not of triglycerides as a surrogate marker. Mgmt notes PDUFA is Sep so formal 55-60d notice to sponsor on any panel is coming up anyway by end of July...
Q2 looks good - note they could be increasing salesforce and preparing for DTC ads.. Scripts are hitting highs and math says we see Q2 north of $90-92M (vs cons $88M). Guidance could be raised on demand but also based on Standard Review not Priority Review. There is a growing view mgmt is preparing to pull forward and further increase salesforce from 400 to 600+ after PDUFA given promotional efforts are paying off and sales appear strong, and next is DTC being approved and planned for H1:20. Street probably needs to raise opex for 2020 for higher spend (but a positive to invest early) and there will probably be bull/bear investor debate on whether another salesforce increase and more opex spend is indicative of ongoing utilization.
https://www.investorvillage.com/smbd.asp?mb=2294&mn=4411&pt=msg&mid=19527434
Recent AMRN News
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal • GlobeNewswire Inc. • 07/17/2024 08:15:00 PM
- Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024 • GlobeNewswire Inc. • 07/17/2024 12:00:00 PM
- Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR) • GlobeNewswire Inc. • 07/08/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/04/2024 01:00:24 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 12:06:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 12:05:56 PM
- Amarin Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
- Amarin to Report Fourth Quarter and Full Year 2023 Financial Results and Host Conference on February 29, 2024 • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/12/2024 01:00:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:31:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:28 PM
Glidelogic Corp. Announces Revolutionary AI-Generated Content Copyright Protection Solution • GDLG • Jul 26, 2024 12:30 PM
Southern Silver Files NI43-101 Technical Report for its Updated Preliminary Economic Assessment for the Cerro Las Minitas Project • SSV • Jul 25, 2024 8:00 AM
Greenlite Ventures Completes Agreement with No Limit Technology • GRNL • Jul 19, 2024 10:00 AM
VAYK Expects Revenue from First Airbnb Property Starting from August • VAYK • Jul 18, 2024 9:00 AM
North Bay Resources Acquires Mt. Vernon Gold Mine, Sierra County, California, with Assays up to 4.8 oz. Au per Ton • NBRI • Jul 18, 2024 9:00 AM
Nightfood Holdings Signs Letter of Intent for All-Stock Acquisition of CarryOutSupplies.com • NGTF • Jul 17, 2024 1:00 PM