Amarin Corporation plc (AMRN) stock forum & discussion – Yahoo Finance (2024)

Just tweeted from BHATT

Pilot Study Finds the Triglyceride Lowering Drug Vascepa May Improve COVID-19 Symptoms

The drug, currently on the market, has been linked to reduced inflammation in people with symptomatic COVID-19.
Becky Upham
By Becky Upham
Last Updated: December 17, 2020

Vascepa pills and coronavirus illustration
Research suggests that the prescription drug Vascepa may help treat the symptoms of mild to moderate COVID-19. Everyday Health
While frontline workers are beginning to get the first round of COVID-19 vaccines, experts agree it will be months before everyone will be protected. In the meantime, researchers continue to look for ways to treat people who have contracted the novel coronavirus.

A new Canadian study presented as a late-breaking clinical trial on December 12 at the National Lipid Association Conference found that the prescription drug Vascepa (icosapent ethyl) shows some promise for treating the symptoms of mild to moderate COVID-19. Those treated with the drug had a 25 percent reduction in the inflammatory biomarker high sensitivity C-reactive protein (CPR), and COVID-19 symptoms were significantly reduced compared with patients who were untreated.

"The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated, and relatively inexpensive option to impact upon COVID-19 related morbidity, though this finding should be confirmed in a double-blind, placebo-controlled trial," said Deepak L. Bhatt, MD, MPH, the executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart and Vascular Center in Boston, a professor of medicine at Harvard Medical School, and a co-author of the study, during his presentation.

“This is a very interesting study with promising results,” says Jim Liu, MD, a cardiologist at the Ohio State University Wexner Medical Center in Columbus. Vascepa (icosapent ethyl) is a formulation of EPA, which is a kind of omega-3 fatty acid that has been known to reduce inflammation, according to Dr. Liu.

“Using it in this way for COVID-19 is very creative and novel. The results indicate that icosapent ethyl can lower inflammation and, more importantly, improve flu-like symptoms after 14 days,” he says.

What Is Vascepa and How Is It Typically Prescribed?

Vascepa was first approved by the U.S. Food and Drug Administration (FDA) in 2012 for adults with severely high triglyceride levels. It was given an additional approval in 2019 as an add-on therapy to reduce the risk of cardiovascular events such as heart attack and stroke in people whose triglyceride levels are 150 milligrams per deciliter or higher.

Normalized scripts from Rafun of ihub.
FYI Ihub poster tucaman is trying to sort out the intricacies of processing the pill count..
SCRIPTS for week ending January 17, 2020

TRX: 79,738 (+81.34% y/y, +3.44% w/w)

NRX: 38,461 (+73.82% y/y, +5.54% w/w)

Refills: 41,277 (+88.95% y/y, +1.29% w/w)

Charts:
https://twitter.com/ra_fun/status/1220721530381926400?s=19

Similar performance to last week, with TRX up 3.4% w/w driven by an almost 6% sequential increase in new prescriptions. Looking at historical seasonality data, it has typically taken Amarin until early-mid February for prescriptions to reach their previous December highs. Based on current run-rates, Amarin will achieve this milestone slightly earlier than in the past (i.e. most likely within the next two weeks of TRX data, as the week of 1/17/2020 needs to increase 6.6% to exceed the week of 12/20/2019 highs

Note from Wainwright

HCW - AMRN: Europe Can Present Second Wind for Vascepa, Despite Program’s Infancy (Buy PT 10)

European Vazkepa on verge of launch; approval expected April 2021. With domestic Vascepa’s European counterpart Vazkepa on the heels of a positive CHMP opinion, we note formal approval from the European Commission is expected in April 2021. Specifically informed by: (1) Amarin’s displayed domestic launch aptitude from Vascepa’s expanded label in cardiovascular (CV) risk reduction; (2) preliminary market access discussions in preparation for commercial launch and (3) the company’s actively growing European commercial team, we believe that pending approval, Vazkepa is well positioned to enter the European market comprised of upwards of millions of patients at high risk for CV events, despite potential statin therapy. While we believe education remains a top priority in terms of Vazkepa awareness and understanding of its CV risk reduction profile, we believe key strategic strengths of the prospective European launch are driven by: (1) Amarin conducting commercial launch without a strategic partner, with the potential to in turn reap the progressive country-by-country commercial benefits based on coverage market access negotiations; and (2) design of its intended label to focus on Vazkepa’s evidenced CV risk reduction benefit and not targeted to triglyceride (TG) reduction, which we note had presented the Achilles’ heel for the threat of generic entry within the U.S. market. A key point to appreciate about prospective European launch is that Vazkepa would be entering a CV market where there are no immediate competitors in the space and with established IP protection from generic entry. While we note Vascepa has continued to perform from a revenue standpoint domestically, reporting 43% year-over-year growth in net total revenue for 2020, we believe that the European presence of Vazkepa can directly drive both CV risk reduction awareness and top-line growth looking into the near-term horizon.

You thought that was it? China approval potentially near end of 2021. We emphasize opportunity for global expansion continues with strategic partner Edding (private) for the potential approval of Vascepa in China, further broadening the reach of its preventative CV risk benefits. We note approval is anticipated near the end of 2021, with: (1) the Chinese National Medical Products Administration (NMPA) reviewing icosapent ethyl for Mainland China approval; and (2) the Hong Kong Department of Health reviewing icosapent ethyl for approval in Hong Kong. Further informed from Edding’s positive topline from its pivotal Phase 3 trial, we believe that a potential approval in the region could be well received among high TG patients at risk for CV events. Lastly, as we turn our sights back to domestic positioning of Vascepa, we believe commercial progress continues to benefit specifically from: (1) Hikma Pharmaceuticals’ (HIK.L; not rated) launch of generic icosapent ethyl comprised of a skinny label targeted to treat severe hypertriglyceridemia (SHTG) patients, which Amarin notes is limited to approximately 7% of current Vascepa usage; (2) continued question of generic manufacturing capacity, product purity and stability; and (3) the prospect of Vascepa being able to potentially compete with regard to pricing informed from co-pays and rebates, as Amarin continues to determine the overall cadence of educational marketing.

4Q in numbers. The company recorded total revenues of $167.3M for 4Q20 compared to consensus of $164.4M, representing 17% YoY growth despite limitations posed by the ongoing pandemic. Total revenues of $614.1M were reported for full-year 2020, and represented 43% YoY growth. The company reported net income of $4.9M, or $0.01/share for 4Q20, and reported net loss of $18.0M, or $0.05/share for full-year 2020. Reported R&D expenses were $39.0M, and SG&A expenses were $463.3M for full-year 2020. As of December 31, 2020, the company reported $563.4M in cash and investments.

Valuation and risks. We reiterate our Buy rating and $10 price target. Our price target of $10 is based on equally weighted average of: (a) $9.23/ share, as a 30x multiple of taxed and diluted FY29 GAAP EPS of $0.95 discounted back to FY21 at 15%; and (b) an NPV of $10.16/share (discount rate 10%, growth rate 2%). Risks to our investment thesis include: (1) Vascepa commercial ramp-up and/or peak sales not meeting our projections; and (2) further competitive disruption of the omega-3 market by branded drugs or generics and/ or OTC supplements beyond our model.

News from Canada. Posted by pharmacy dude on ihub.

The Canadian Cardiovascular Society just published their new recommendations in the Canadian Journal of Cardiology recommending Icosapent Ethyl for the treatment of cardiovascular disease in Canada.
A very important point is that it is listed as a strong recommendation with high-quality evidence!!!!

The new 2021 CCS dyslipidemia guidelines is now available online: https://www.onlinecjc.ca/article/S0828-282X(21)00165-3/fulltext

Icosapent ethyl is recommended to lower the risk of CV events in patients with ASCVD, or with diabetes and ≥1 CVD risk factors, who have an elevated fasting triglyceride level of 1.5-5.6 mmol/L despite treatment with maximally tolerated statin therapy (Strong Recommendation; High-Quality Evidence).

About todays presentations (if already linked here no harm done).

[quote]AMARIN-SUPPORTED RESEARCH AND ANALYSES FROM ACADEMIC COLLABORATORS TO BE FEATURED IN TWO LATE BREAKER AND SIX E-POSTER PRESENTATIONS, INCLUDING ENCORE OF REDUCE-IT® EPA, PRIMARY RESULTS OF THE VASCEPA COVID-19 CARDIOLINK-9 TRIAL, AND MECHANISM OF ACTION INSIGHTS
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that scientific findings that add to the growing body of knowledge on VASCEPA® (icosapent ethyl) will be presented during the National Lipid Association (NLA) Scientific Sessions 2020, being held virtually from December 10 – 12, 2020. These findings will be featured in two Late Breaker and six e-Poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin.

“We are pleased to support several Late Breaker and numerous e-Poster presentations at the upcoming NLA Scientific Sessions 2020,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “We continue to showcase data from our REDUCE-IT® study demonstrating the unique and proven efficacy of VASCEPA in cardiovascular risk reduction while providing support to investigators to explore other ways in which VASCEPA can potentially impact public health.”

Amarin added that the Late Breaker presentation of the VASCEPA COVID-19 CardioLink-9 Randomized Trial is of primary results from a trial supported by Amarin and HLS Therapeutics, Inc. that was conducted by independent investigators.

Featured Amarin-supported Late Breakers to be presented:

[b]“EPA Levels and Cardiovascular Outcomes in the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial” – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD – December 12, 4:30-5:15 pm CST[/b]

[b]“First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial” – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital, Harvard Medical School, Boston, MA – December 12, 4:30-5:15 pm CST[/quote][/b]
https://investor.amarincorp.com/news-releases/news-release-details/vascepar-icosapent-ethyl-related-scientific-findings-be

There does not seem to be web/pod cast arranged from any of the events (that I have been able to find anyway)

AMRN closed ABOVE the 50 day moving average today, on the WEEKLY chart, for the first time since 12/4, when it closed at $5.01. Once it closed above 50 day moving average AMRN proceeded to Double over the next 8 weeks , hitting $9.25 per share on 2/5.

With 20m shares short & average daily volume just a couple million, & a couple short months from Vascepa Launching in Europe.

Currently AMRN have generated over 600M in revenues, drug only being approved in late 2019. Cardiovascular Disease is the #1 cause of death. TEVA pharm recently discontinued their Generic version , and
Additionally the CEO clarified today, generics do not pose a Viable threat to AMRN as 1) physicians Favor Writing the Brand name due to multiple reasons including a. Minimal savings if any at all when compared with Vascepa b. Due to lack of avail. With generics, as generic makers have not ramped up manufacturing/ production c. Education

Either shares less then $5, it may be a matter of a short period of time before AMRN valuation prices in Vascepa sales coming down Germany and larger Europe with sales set to accrue late summer. Remember Europe Provides 15 year exclusivity from March 2021.

FiercePharma article from Ihub post:
“.......however, the drugmaker is still keeping itself open to a possible marketing partnership—or buyout—with a large-cap pharma if the opportunity arises.
“We are focusing on that which we can control, which is the aggressive growth of this business, and we are confident that we can do this on our own,” Thero said. “But we’ll always review what choices exist.”
RELATED: Another win for Vascepa: Pricing watchdog ICER calls Amarin's fish-oil pill cost-effective
Vascepa has seen a staggering increase in prescriptions after the drugmaker’s phase 3 readout of its Reduce-It trial showed a 25% cardiovascular risk reduction in patients with abnormally high triglyceride levels. Vascepa scripts jumped more than 75% after data from Reduce-It was released in October, and Cantor Fitzgerald analyst Louise Chen said those figures could actually be an undershot of how fast the drug is selling.”

I’m buying on the dips and aiming for 10,000 total shares by December. GLTA!

I did say that I wanted an AdCom because the broad label would more than double Vascepa's market and that was better for long term shareholders.

I was right and it did happen because Amarin is going for the motherlode. It won't matter 6 months from now anyway. Those that loaded up will be smiling even if they bought at $23.91 the 52-week high as of today August 21, 2019.

Where AMRN is going is beyond the market cap of Lipitor's sales in its first 7 years and that's why any buyout to be considered must be high enough to get a Yes vote from management that knows the value of Vascepa.

Question is...Do Investors Know what they have with their AMRN shares?
https://www.crainsnewyork.com/article/20111228/HEALTH_CARE/111229902/lipitor-becomes-world-s-top-selling-drug

Indications for pure EPA:
CVD 2018
Diabetes 2019
Alzheimer's 2021 (coming) https://clinicaltrials.gov/ct2/show/NCT02719327 (BRAVE-EPA trial)
Cancer 2023 (coming) https://clinicaltrials.gov/ct2/show/NCT03661047 (OMICC trial)

April 1, 2022 7:00 AM EDT
Eicosapentaenoic Acid (EPA) Combined with Widely Used Statins Significantly Reduced Lipid Oxidation in Model Membranes ,, great news now just get out there and get the world using Vascepa !

"“The message that emerged for us from these in vitro study results was that, while statins and EPA can work independently to reduce lipid oxidation which can contribute to cardiovascular risk, they might work even better together,” said Dr. Mason. “This is an important finding with potential implications in particular for those facing persistent, elevated cardiovascular risk or who have had a prior event, as they may need more potent solutions than the standard of care can provide.”

“These findings are another compelling piece of evidence in line with our beliefs regarding the potential for increased benefit to appropriate high-risk patients from VASCEPA/VAZKEPA in combination with statins, consistent with the results from the REDUCE-IT® trial, and supports Amarin’s decision to focus on research and development efforts toward the possible development of a combination product,” said Karim Mikhail, Amarin’s president and chief executive officer.

An interesting post from ihub poster Keystone_Investments..post is below:

Keystone_Investments Tuesday, 01/21/20 04:13:03 PM
Re: None0
Post #
242665
of 242699
AMRN Valuation Discussion.

There have been several posters that have opined regarding AMRN valuation whether that be as a multiple of peak revenue or discounting EUR valuation based on royalties, etc. I'd like to add my view as a former investment banker involved in M&A transactions.

Valuation essentially boils down to discounting a stream of future free cash flows.

While the above sentence may make sense to many folks here, there's a lot of assumptions that go into this type of projection model. Patent protection assumptions across different geographies is one of them. How quickly and how big will revenues grow in each market and for how long. At what margin. What other income streams are reasonable in your valuation (DE, ALZ, cancer, NASH, etc.; you can bridge that last point with CVRs). What discount rate do you use to calculate your NPV (net present value). Note that the discount rate is different if you are AMRN or a BO contender. These are just some of the issues and there are many more (e.g., SG&A, tax rates, tax loss carryforwards, etc.)

When looking at a multiple of peak revenues, this is usually derived from your NPV divided by peak revenues and not by itself a primary deterministic valuation factor. Think about what peak revenues will be right before patent expiration. It's highly unlikely that you'll get 5x revenue at that stage of your drug product life cycle.

As for looking at EU as a royalty stream, that is important for AMRN, however, any BO contender will look at the NPV of DCF for the EUR market to determine the value to the acquirer.

The equity analysts covering AMRN all have DCF models that have determined their valuation on a GIA basis or in a BO scenario. As I run down the list of analyst estimates I see a GIA SP target of 22-51 (not including the Opp clown). The average is $31. I think all but one of the analysts are too low.

As for BO vs GIA, the numbers will tell the story. AMRN has developed a very valuable drug and BP knows this and certainly wants it. My guess is that the projection models have been tweaked by BP contenders and by AMRN internally and there is a current valuation gap. This gap can close via continued script growth, continued de-risking (e.g., patent, operational and supply) or possibly a CVR structure. These models are likely advanced at this stage by many interested parties, so any M&A offers can be swift.

Whether you are a "BO Boy" or in the "GIA Gang", I believe we will wake up one morning with news of a BO offer. I'm not saying it gets approved, but with a BB drug this attractive, it's very likely going to happen. Resolution of the patent issue will be a de-risking event and as one analyst has already indicated, "will open the M&A window". We are not yet at peak valuation for AMRN as the impact of continued de-risking (via the discount rate) is more than offsetting projected future FCF. That will reverse certainly within the next year and perhaps much sooner.

That's my 2 cents. I am not posting my valuation for AMRN, but I will say that I am a very large shareholder and have owned and increased since 2010.

nice to see that Denner has not sold any shares .. and based on today's volume it would be reasonable to consider he is adding to his lot .. also the clarity as to time of the 13D filed his percentage of total shares

Item 5. Interest in Securities of the Issuer. Item 5(a) of the Schedule 13D is hereby amended and restated as follows:
(a)
The Reporting Persons may be deemed to beneficially own, in the aggregate, 24,000,000 Shares representing approximately 6.05% of the outstanding Shares, based upon the 397,008,153 Shares outstanding as of April 29, 2022, including 396,811,326 ADSs, and 196,827 Ordinary Shares, as set forth in the Form 10-Q of the Issuer filed with the U.S. Securities and Exchange Commission on May 4, 2022.

As everyone knows, there have been a number of lawsuits filed against AMRN over the last several weeks. At some point these will be consolidated and filed some law firm. Eventually, this will be dismissed as 99% of these have in the past. This is only a rouse by individuals attempting to drive the share price down and fleece retail investors. Volume was someone light after the initial lawsuit was announced and has slowly picked up pace. In addition, there has been a barrage of bashers attacking the credibility of management attempting to accelerate selling. To me this is a positive sign.

Here the deal, a number of micro to small cap biotech firms with just a few - or just one - products in their portfolio are easily manipulated by just a few. I suspect there's a buyout on the horizon based on precedent. Example #1- HGSI launched its lupus drug in 2011 with poor execution. HGSI faced an investor suit in June 2012 under similar AMRN circ*mstances. GSK bought the company in August 2012. Don't believe me . . . . check it out. Medivation faced an investor lawsuit and was bought by Pfizer in September 2016. Kite Pharma same situation as Medivation - although their litigation was more centered around the actual sale. Point is ...... litigation is brought on behalf of shareholders with someone's attention to affect share price. Tesaro faced an investor lawsuit in March of 2018 for investors on record from January '16 - Aug '17 supressing investor confidence and lowering share price. TSRO was bought by GSK in Dec 2018. AMRN may or may not be a target, but there's a strong indication something's up based on what's happened in small cap biotech