Amarin Announces Comprehensive Cost Reduction Plan To Address Market Dynamics In Us Business
— Company Expects to Achieve Approximately $100 Million in Cost Savings Over the Next 12 Months* While Continuing to Invest in European Launches and Global Expansion — — Reduces U.S. Commercial Organization by Ninety Percent of Pre-Pandemic / Pre-Generic Competition Levels — — Creates Core Focused U.S. Commercial Team to Support Branded VASCEPA Revenues — — Actions Optimize Operations While Maintaining Positive U.S. Contribution Margin to Support Companys Next Steps — DUBLIN, Ireland an
Amarin Outlines $100m Cost Saving Plan
Amarin Corporation plc announced a comprehensive cost and organizational restructuring plan to reduce operating costs by approximately $100 million over the next 12 months. The restructuring will enable Amarin to maintain a positive contribution margin in the U.S. while investing in its European market launches and global expansion for Vascepa/Vazkepa. The majority of the cost savings will result from a significant workforce reduction across the Company’s U.S. field force and corp
What Should Investors Do
In the animated classic Alice in Wonderland, the White Rabbit said: “Don’t just do something, stand there.” That’s wonderful counterintuitive advice. In a physical emergency, you might need to run and shout and wave your arms around sometimes speed is essential. But when you’re investing your money in a business, you should take your sweet time. That includes buying as well as selling. There is no rush.
In Amarin’s case, the key is what will happen in the future. Of course, a monkey wrench has been thrown into the company’s plans. Yet Amarin has a lot of cash — $645 million . Before COVID-19 struck, the company had also had very impressive revenue growth.
Nobody knows how big this market will ultimately be estimates vary wildly. Nor is it known whether the FDA will allow the generics to claim all the cardiac health benefits that Amarin found with Vascepa it’s entirely possible that the FDA will allow generic versions of the drug, but only to reduce high triglycerides. And, finally, from the brief legal research I’ve done, it appears the standard of review at the court of appeals will be de novo, which means the appellate court is not bound by the trial judge’s ruling.
I think for now the best course is to do nothing, and wait and see how it all plays out.
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Why Amarin Is Stuck In A Trading Range
- The fundamentals have improved in the meantime.
- Vascepa sales should continue to accelerate in the following quarters.
- I outline the potential issues that may be holding the stock back.
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Shares of Amarin are trading in a relatively narrow range since the start of 2019 and the buyout rumor-induced rally . Since then, we’ve seen another buyout rumor in February was rumored to be the potential suitor in January and Novartis in February), the company presenting more positive data and Vascepa being added to American Diabetes Association guidelines. On top of that, Vascepa prescriptions are making new highs almost every week. And yet, that was not enough for the stock to trade higher and make new 52-week highs. In this article, I summarize the recent developments and lay out the potential reasons why the stock hasn’t made progress in the last few months.
Should You Still Invest
At the time of writing, its down at $4.48. How should you invest in Amarin stock? Will it grow because of overseas markets? Or will it stay down due to generic heart meds?
Remember when we said Wall Street suggests holding the stock? This means you should keep it if you already have some. Otherwise, its best not to buy Amarin stock this year.
Then, think about the demand for heart medicines. If the company sells more VASCEPA to other countries, this could increase sales. As a result, its stock price could rise once more.
It chose countries that have numerous people with heart conditions. Thats millions upon millions of potential buyers of VASCEPA. Still, the generics could be a risk.
The generics might become as effective as Amarins drug. Also, they could cost far less. In turn, customers may pick those over Amarins meds.
More importantly, consider the pandemic. Sadly, its not over yet. Countries locked down to prevent the spread of COVID. However, it came at the expense of their economies.
As a result, were going through a shortage of various important products. Supply chains arent back to normal. Getting goods back and forth among countries is still hard.
This could affect other materials used for VASCEPA. If not, it might cause problems with its distribution in several countries. This may shoot up prices, too, reducing potential buyers.
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Amarin To Present At Two Upcoming Investor Conferences
DUBLIN, Ireland and BRIDGEWATER, N.J., May 12, 2022 — Amarin Corporation plc today announced that Karim Mikhail, Amarins president and chief executive officer, will present at two upcoming investor conferences: H.C. Wainwright Global Investment Conference Date/Time: May 25, 2022, 12:00 p.m. ET/5:00 p.m. GMT+1Webcast: https://journey.ct.events/view/7aff40b1-3f90-47dd-a827-a30d854fea27 Jefferies Healthcare Conference (June 8-10, 20
Amarin’s Vascepa sales decline year over year amid rising generic competition and COVID-related disruptions during the first quarter. The company’s stock falls significantly on May 4.
Trends And Technical Analysis: Amarin Corporation Plc
Raw Stochastic average of Amarin Corporation plc in the period of last 50 days is set at 36.95%. The result represents downgrade in oppose to Raw Stochastic average for the period of the last 20 days, recording 87.32%. In the last 20 days, the companys Stochastic %K was 87.08% and its Stochastic %D was recorded 83.21%.
Now, considering the stocks previous presentation, multiple moving trends are noted. Year-to-date Price performance of the companys stock appears to be encouraging, given the fact the metric is recording -40.95%. Additionally, trading for the stock in the period of the last six months notably deteriorated by -41.64%, alongside a downfall of -56.17% for the period of the last 12 months. The shares increased approximately by 9.94% in the 7-day charts and went down by 41.13% in the period of the last 30 days. Common stock shares were lifted by -39.14% during last recorded quarter.
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Amarin Appoints Tom Reilly As New Chief Financial Officer
— Experienced Executive Brings More Than Twenty Years of Global Financial Leadership to Amarin — — Michael W. Kalb to Depart Amarin to Pursue Other Interests — DUBLIN, Ireland and BRIDGEWATER, N.J., June 06, 2022 — Amarin Corporation plc today announced the appointment of Tom Reilly as Chief Financial Officer, effective June 20, 2022. The appointment follows the resignation of Michael W. Kalb who will leave the Company to pursue other interests after a brief t
Why Shares Of Amarin Corporation Dropped 461% In May
Amarin Corporation , a biopharmaceutical company that specializes in cardiovascular therapies, saw its shares plummet 46.1% in May, according to data from S& P Global Market Intelligence. The company has only one marketed therapy, Vascepa , which is designed to reduce the risk of stroke or heart attack by lowering harmful triglycerides, a type of fat in your blood. The problem for Amarin is that Vascepa now has three generic competitors compared to only one at this time last year.
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Amarin’s Stock Dropped 70% After Its Patent For Vascepa Was Invalidated By A Federal Judge
On Monday, Amarin investors got some horrible news. A federal judge in Nevada declared that the company’s intellectual property was “obvious” and its drug patent was invalid.
This was a complete shock to many investors, including yours truly. Amarin only has one drug, and now the company has lost the rights to it in the United States. Yesterday I was saying, “This is legalized theft.”
My Thoughts On The Adcom
The AdCom will be a chance for Amarin to educate key opinion leaders and defend the positive results of the REDUCE-IT study, which indicates that Vascepa could help millions of cardiovascular patients. In fact, Amarin CEO John Thero stated,
“Based upon REDUCE-IT results, if all statin-treated patients in the United States with elevated triglyceride levels were treated with Vascepa, the company estimate that major adverse cardiovascular events such as stroke, heart attack, and cardiovascular death could in aggregate be reduced by 150,000 to 450,000 per year.”
Reducing 150K to 450K CV events each year would transform healthcare in the U.S. by helping patients, providers, and even payers. The only entity being hurt would be the embedded competition. I believe the data and anecdotal evidence will support Vascepa in the AdCom.
My biggest concern will be the FDA’s attack on the REDUCE-IT trial design, which would then question the Vascepa proposed label. I am not sure what angle they take, but I am sure they will find an edge to pry into.
I expect Amarin to be prepared for everything the FDA throws at them. I am hoping the company is able to bring a few key opinion leaders, patients, and current prescribers to the AdCom for the public forum section. According to the company,
“Approximately 100 comments have been written to the FDA expressing their reasons for why Vascepa should be approved promptly for cardiovascular risk reduction.”
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Amarin Outpaces Stock Market Gains: What You Should Know
In the latest trading session, Amarin closed at $19.75, marking a +0.71% move from the previous day. This move outpaced the S& P 500’s daily gain of 0.46%. Meanwhile, the Dow gained 0.15%, and the Nasdaq, a tech-heavy index, added 0.59%.
Coming into today, shares of the biopharmaceutical company had lost 7.93% in the past month. In that same time, the Medical sector gained 0.72%, while the S& P 500 gained 3.24%.
AMRN will be looking to display strength as it nears its next earnings release. In that report, analysts expect AMRN to post earnings of -$0.06 per share. This would mark year-over-year growth of 14.29%. Meanwhile, our latest consensus estimate is calling for revenue of $72.23 million, up 64.46% from the prior-year quarter.
Looking at the full year, our Zacks Consensus Estimates suggest analysts are expecting earnings of -$0.07 per share and revenue of $370.57 million. These totals would mark changes of +78.79% and +61.67%, respectively, from last year.
Any recent changes to analyst estimates for AMRN should also be noted by investors. These recent revisions tend to reflect the evolving nature of short-term business trends. As a result, we can interpret positive estimate revisions as a good sign for the company’s business outlook.
The Medical – Biomedical and Genetics industry is part of the Medical sector. This industry currently has a Zacks Industry Rank of 78, which puts it in the top 31% of all 250+ industries.
Everything Is Going The Right Way But It Looks Like The Market Needs More
As I mentioned in the introduction, everything is going the right way for Amarin so far in 2019:
- The company handily beat Q4 revenue estimates and provided what I believe is very conservative 2019 revenue guidance of $350 million, which translates to 50%+ Y/Y growth and which represents acceleration from 26% growth in 2018.
- The company presented additional REDUCE-IT results at ACC in March, showing Vascepa has achieved a 30% risk reduction in total cardiovascular events .
- Vascepa was added to ADA guidelines in late March, a pleasant surprise as the ADA embraced Vascepa before label expansion to include REDUCE-IT data.
- The company submitted the sNDA to the FDA for Vascepa’s label expansion in late March.
- Vascepa prescriptions are growing rapidly, and I estimate that the current annualized net sales run rate is in excess of $350 million.
On top of all the positive developments, Amarin has been the subject of two buyout rumors in the first quarter – Pfizer in and in . So, why are we not seeing the stock make new 52-week highs? While I don’t know the exact reason or reasons, I will try to answer that question with a couple of points and risks to the thesis .
Going forward, we should see additional waves of growth acceleration:
It is possible that investors are not fully satisfied with Vascepa’s prescription growth to date, but we are still in the very early stages of growth and I don’t have any concerns regarding the execution of Vascepa’s long-term potential.
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Amarin To Report First Quarter 2022 Financial Results And Host Conference Call On May 4 2022
DUBLIN, Ireland and BRIDGEWATER, N.J., April 19, 2022 — Amarin Corporation plc today announced that it will host a conference call with members of Amarins senior management team to discuss the Company’s first quarter 2022 financial results on Wednesday, May 4, 2022 at 8:00 a.m. ET. The conference call will follow the anticipated release of the Company’s financial results earlier that day. Conference Call and Webcast Information:Access to live call:Go to the inves
Amarin Corporation Plc Stock Trading Halted Today For Scheduled Fda Advisory Committee Review Of Snda Seeking New Indication For Vascepa To Reduce The Risk Of Major Adverse Cardiovascular Events Based On Landmark Reduce
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 14, 2019 — Amarin Corporation plc , a pharmaceutical company focused on improving cardiovascular health, today announced that NASDAQ has halted trading of the company’s shares. The U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee , as previously scheduled and announced, is meeting today to openly discuss the company’s supplemental New Drug Application seeking a new indication for Vascepa® to reduce the risk of major adverse cardiovascular events based on the landmark REDUCE-IT® cardiovascular outcomes study.
The Advisory Committee meeting is scheduled for 8:00 a.m. ET. The briefing materials can be found on the FDA website at . The Prescription Drug User Fee Act goal date for the FDAs review of Vascepas supplemental New Drug Application is December 28, 2019.
The EMDAC reviews and evaluates data concerning the effectiveness and safety of marketed and investigational human drug products under review at the Division of Metabolism and Endocrinology Products at FDA and makes appropriate recommendations to the division. The FDA is not bound by the recommendations of an advisory committee.
About Amarin
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Eicosapentaenoic Acid Combined With Widely Used Statins Significantly Reduced Lipid Oxidation In Model Membranes
Experimental trial research presented at the American College of Cardiologys 71st Annual Scientific Session showed that the combinations of EPA/atorvastatin active metabolite and of EPA/rosuvastatin reduced lipid oxidation by 86% and 75%, respectively DUBLIN, Ireland and BRIDGEWATER, N.J., April 01, 2022 — Amarin Corporation plc today announced in vitro research results suggesting that Eicosapentaenoic Acid , in combination with widel
Amarin Provides Preliminary 2020 Results And 2021 Outlook
Unaudited 2020 Total Net Revenue Estimated to Be Approximately $610 Million, an Increase of Approximately 42% Compared with 2019
Completion of European Regulatory Review and Submission of China Regulatory Application for VASCEPA® Expected in Late January or February 2021
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 07, 2021 — Amarin Corporation plc today provided a business update, including preliminary unaudited full-year 2020 revenue results. Amarin plans to discuss these results and expectations with investors in connection with the 39th Annual J.P. Morgan Healthcare Conference at which Amarin is scheduled to present on Tuesday, January 12, 2020, at 2:00 pm Eastern time.
Preliminary 2020 Financial Results
Record Revenue Levels: Full-year 2020 total net revenue, subject to audit, are expected to be approximately $610 million. Despite the impact of COVID-19, this estimated 2020 net revenue expectation represents an increase of approximately 42% compared with full-year 2019 results. This growth was primarily driven by increased prescription levels of VASCEPA® in the United States.
Liquid Assets: Amarin ended 2020 with more than $550 million in cash and investments, approximately $150 million in net accounts receivable and approximately $180 million in inventory.
Highlights from 2020 and Outlook
U.S. Commercial
U.S. commercial highlights from 2020 include:
Further expanded managed care coverage for VASCEPA during 2020 with additional improvements agreed for 2021
Europe
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Let’s Start With A Firm Foundation
BioMarin has reported increased revenue in each of the past 15 years and is on track to continue that growth this year. Through nine months, the company’s reported revenue was $1.4 billion — up 13% year over year — and its net income was listed as $837 million, compared to a net loss of $38.9 million in the same period in 2019.
BioMarin’s niche is in rare genetic disease therapies. While these drugs may not have the consumer demand that say, a cure for baldness might, that also means less competition and a degree of patent and price protection. That explains the company’s gross profit margins, which are above 73%.
Metabolic disorder drug Vimizim is still the company’s biggest earner. The company said the drug produced revenue of $401 million through nine months, down 2% year over year, but it has other drugs that appear to be on their way up. Kuvan, which treats phenylketonuria , a rare inherited disease where the amino acid phenylalanine builds up in the body, had sales of $368.7 million, up 8% year over year. The company’s fastest riser was another PKU drug, Palynziq, which increased sales to $121.4 million, up 120% over the prior year.
The company also released positive Phase 3 study information regarding Vosoritide to treat achondroplasia, a bone growth disorder that is characterized by dwarfism. In the study, the company said children with achondroplasia given a daily injection of Vosoritide increased growth velocity through their second year of treatment.
Amarin Announces Appointment Of New Directors And Board Leadership Changes
Erin Enright and Alfonso Chito Zulueta Appointed to Board of Directors New Board Members Bring Skills and Experience Aligned with the Companys Strategy Per Wold-Olsen Named Chairman of the Board David Stack and Joe Zakrzewski to Retire from the Board Actions Reflect Company and Boards Commitment to Ongoing Refreshment and Enhancement DUBLIN, Ireland and BRIDGEWATER, N.J., May 19, 2022 — Amarin Corporation plc today announced a series of appointments and leader
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