Amarin Corporation plc (NASDAQ:AMRN) Third Quarter 2022 Results Conference Call October 27, 2022 8:00 AMm. ET
Participating companies
Lisa DeFrancesco – Senior Vice President, Corporate Affairs and Investor Relations
Karim Mikhail – President and Chief Executive Officer
Tom Reilly – Chief Financial Officer
Conference Call Participants
Michael Yee – Jefferies
Georgi Yordanov – Cowen and Company
Roanna Ruiz – SVB Leerink
Carvey Leung – Singer Fitzgerald
Daniel Wolle – JP Morgan
Paul Choi-Goldman Sachs
Operator
Welcome to the Amarin Corporation convention call to discuss monetary effects and the third quarter 2022 operating update. This convention call is being recorded on October 27, 2022.
Now I would like the convention to call Lisa DeFrancesco, senior vice president of Investor Relations and Corporate Affairs at Amarin.
Lisa de Francesco
Hello everyone and thank you for joining us. Please note that this convention call will include forward-looking statements that are intended to be covered through the port under the Private Securities Litigation Reform Act. We may not achieve our goals, plans or intentions or meet the expectations revealed in our future. looking for statements.
The actual effects or occasions may differ from the curtains, so you should not place undue reliance on those statements. We assume no legal responsibility to update those statements when cases change. Our forward-looking statements do not reflect the potential effect of curtains. transactions in which we would possibly participate, such as mergers, acquisitions, divestitures, joint ventures, or any curtain agreements that we would possibly enter, modify, or terminate.
For more data related to threat points that may cause actual effects to differ materially, please refer to the Risk Factors segment of our Annual Report on Form 10-K for the year ended December 31, 2021 and our Form 10-Q for the quarter ended. September 30, 2022, which were filed with the SEC and are now available in the Investor Relations segment of our online page in www. amarincorp. com. We inspire everyone to read those documents.
This call is intended for Amarin investors and is not intended to publicize the use of VASCEPA. An archive of this call will be posted in Amarin’s Investor Relations section.
Karim Mikhail, President and Chief Executive Officer of Amarin, will lead our discussion, and Tom Reilly, Amarin’s new Chief Financial Officer, will provide a more detailed review of our third quarter 2022 monetary results. After the comments are ready, we will open the call for your questions.
I remind you that many audiences pay attention to calls of this nature, adding existing investors, new potential investors, employees, current and potential collaborators, and current and potential competitors. As always, in this call, we will seek to provide constructive data without compromising our competitive and strategic positioning.
I will now turn the floor over to Karim Mikhail, President and CEO of Amarin. Karim?
Karim Mikhaïl
Thank you, Lisa. Bonjour. Et, thank you all for joining us today. This year, we began embarking on an ambitious strategy of global expansion and expansion. We have focused our strategy on three-dimensional expansion, broad or geographical, with heights that represent diversification and intensity or basic operational evolution.
Now that 2022 is coming to an end and despite the headwinds and significant demanding situations we faced earlier in the year, we are pleased to report that we have made significant progress on our most sensitive priorities and continue to deliver on what we have committed to. to.
Most importantly, we have changed our levels of money consumption by strengthening our foundation of operational excellence, strengthening our leadership team and laying the foundation for a true transformation of Amarin in 2023.
I will begin today by discussing the effects of our money-preservation initiatives, as this progress is vital and imperative to help our long-term expansion and expansion plans.
Two key projects have been at the heart of our efforts and progress. First, in June, we took swift action by pronouncing a comprehensive savings plan to reduce our operating expenses by $100 million over 12 months. organization. And we’re starting to realize this quarter’s savings exactly as planned.
Second, beginning last quarter, and as part of our company-wide operational excellence purpose, we took steps to evolve our supply chain strategy and modify our supplier agreements to align supply agreements with existing and long-term demand within our U. S. operations. U. S.
These initiatives, which Tom will talk about in more detail shortly, resulted in a significant quarter-over-quarter decline in money consumption. In fact, this quarter we have a positive cash flow, restructuring charges.
The continued stabilization of sales in the U. S. The U. S. economy over the past 3 quarters, despite the continued strain of increased generic competition, also contributed to the improvement in our monetary margin. We have achieved this by refocusing our core team’s efforts in the U. S. .
In addition, and due to difficult decisions made at the right time for our commercial presence in the U. S. In the U. S. , we remain very profitable and support long-term foreign growth. Looking at our third quarter and U. S. results. In the U. S. , I’m pleased to say that our strategy is labor.
In the third quarter of 2022, we posted an overall net income of $89. 9 million, adding $87. 9 million from U. S. product sales. The U. S. economy is largely unchanged from last quarter, despite continued generic competitive tension and the restructuring effort we announced in June, which particularly curtailed our U. S. marketing and sales efforts. U. S. and business footprint. It is now the third consecutive quarter with consistent earnings functionality, despite continued generic competition, which is unprecedented in the industry. And third-quarter functionality was achieved with a more effective footprint and resources, which is a testament to the strength and effort of the U. S. core team. U. S.
Our efforts to focus on selling our logo are working. Based on the latest prescribing trends, we currently have a current share of approximately 60% of the overall PEI market on a quarterly basis. We will continue to closely monitor market dynamics in the U. S. A position to adjust if required where possible.
With the stabilization of the business in the U. S. And the ambitious money-preservation measures we’ve taken, we’ve been able to expand our money route to make sure we can fund our expansion plan.
While I started today’s discussion with recent moves committed to strengthening our capital base and preserving our revenue in the United States, we have remained focused on our number one long-term focus, which is global expansion and expansion of VASCEPA, VAZKEPA in Europe and around the world as this is the key to shareholder pricing.
2022 about laying the foundation for our long career in Europe, and now we are starting to see the shape of the scene before our eyes. We are now officially in the market and in the ad launch phase in the UK and Sweden.
We recently obtained a final positive national refund in Finland and Northern Ireland for a value in line with our recent value in the UK. We also obtained an individual refund in Austria, with the ongoing procedure for a domestic refund.
While there is no consistent timeline in any of the remaining primary markets, we have been negotiating the redemption lately and are now in complex stages in all markets. resolution of prices and reimbursement in a time before the end of 2022.
In the Netherlands, we obtained a clinical evaluation from the National Institute of Health, ZIN, for reimbursement and are initiating tariff negotiations with the Dutch Ministry of Health.
In Italy, we have taken the key step of a clinical evaluation, allowing our dossier to move from the clinical evaluation phase to the phase of negotiating fees and reimbursement with the Italian authorities.
Our strategy has been to create a strong, diversified and sustainable profit stream in Europe. That is why we have filed claims in thirteen markets simultaneously since 2021, and lately we are in the intermediate stages of reimbursement negotiations in France, Italy, Spain, the Netherlands and Norway.
This progress to date, and more particularly the net worth reimbursement point we have received, recognises the cost of VAZKEPA and our ability to demonstrate that cost to taxpayers across Europe.
As for marketing efforts in Europe, UK, our launch has been underway since mid-October and is progressing well and in line with our expectations based on our market depth.
To provide context in the UK market and how it works, there are 3 distinct degrees of healthcare management in England: NHS England or National Health Services, which provides recommendations on use. Second, embedded care systems are consolidations of organizations planning service delivery and funding. The last point is local accounts with forms, which lists the product refunded.
As you will recall, since we got our final approval in July, we have followed the typical procedure while waiting for the approval of public funding. We spent the first 90 days after approval focusing on accessing the form through education, medical and clinical engagement, implementing form guidelines, and increasing awareness and adoption through educational and marketing channels.
And, at the same time, we are building a strong team in the UK. As I mentioned earlier this month, public investment is now adequate and we are moving to the advertising approach.
Enrollment in the VAZKEPA formulary continues to outperform analogues and improves weekly, thanks to the transparent step-by-step technique to achieve registration in the formulary and inclusion in the drug pathway. We are proud that VAZKEPA is making its way as a popular new care provider to lessen the threat of CV events beyond LDL-C control in England. We will update investors on our UK functionality so everyone can track our progress against benchmarks in the coming quarters.
As for the rest of Europe, we are also making progress in other markets and continue to advance our reimbursement discussions with the national fitness government in Norway, Italy, France, the Netherlands, Portugal and Switzerland, where we recently introduced and now have registration for reimbursement discussions.
We are still on track to obtain reimbursement decisions in up to 8 countries and launch VAZKEPA in up to six European countries this year. And we remain confident that 2023 will be the beginning of a solid and sustainable profit generation of more than a billion dollars. , as well as cutting-edge opportunities in Europe.
Our progress continues beyond Europe, where we are carrying out our registration plan in up to 20 countries until 2024. I am pleased to say that we have deposited in 10 markets with the prospect of several others before the end of the year and the beginning. 2023.
Specifically, Amarin’s marketing authorization programs for VASCEPA/VAZKEPA were received in Hong Kong, Saudi Arabia and Bahrain, and the programs are still pending in several other markets, adding Australia and New Zealand, which continue to advance their local procedures. It also showed that our regulatory filings are lately under active scrutiny in South Africa and other markets. This is as we continue our search for the right spouse in all foreign jurisdictions where we do not plan to build our own infrastructure.
Our existing spouses also continue to make progress, adding that Eddingpharm, our spouse in China, recently said that he obtained confirmation that the Chinese government has finished testing the product and ushered in the era of final review before approval. This final exam is earlier this month and has a clock of up to 67 business days. Our spouse has informed us that he anticipates that approval can still be received before the end of the year.
In Canada, HLS Therapeutics Inc. has been reimbursed through all primary public payers, winning the vast majority of eligible patients in Canada. They are still in the launch phase in the public sector.
We are confident of the multi-billion dollar global market opportunity for VASCEPA/VAZKEPA in Europe and internationally. And we continue to invest in building our knowledge and evidence on POI, now with a global approach.
After a prominent presence at the European Society of Cardiology Congress over the summer, we remain committed to maintaining a strong presence at vital medical meetings, adding the upcoming Canadian Cardiovascular Congress, the American Heart Association and the International Society for Pharmaceutical Outcomes Research in Europe. , which is a leading convention for discussing fitness care outcomes research. Our knowledge was decided by a presentation that demonstrates the cost-effectiveness of VASCEPA in the treatment of cardiovascular disorders in the Netherlands.
Finally, we are proceeding to expand our fixed-dose combination, ensuring our continued progress with this program that combines a placebo with a statin.
To summarize our year-to-date progress, we are experiencing strong business trends in the U. S. In the U. S. , we are taking significant steps to maintain our cash flow, our global expansion plans are still underway, and we continue to provide evidence of knowledge of building and advancing our portfolio. Advancing.
With that, I’ll move on to Tom to communicate more about our progress and the strong effects of this quarter. AM?
Tom Reilly
Thank you Karim. Hello everyone. I must provide our monetary functionality for the third quarter of 2022.
I am pleased to note that the second quarter restructuring invoices of $25 million made in the third quarter, we had a positive position in the money in the third quarter of 2022.
Let me start with the functionality of our income. For the third quarter of 2022, we recorded overall net sales of $89. 9 million, adding net income of $89. 2 million, a low of 37% compared to the third quarter of 2021. Usa. U. S. sales were $87. 9 million, just $2. 8 million less than in the current quarter of 2022, reflecting solid trends in volume and price.
Since last quarter, we have not been making an investment to expand IPE in the U. S. market. But we’re making an investment to keep up and support with a distinctive logo and prescriber base we have today in the U. S. U. S.
While we are pleased with a relatively strong trend, we expect volumes and costs to continue under some pressure this year and next. The results come with foreign product revenue of $1. 3 million, which comes with European product revenue of $0. 7 million.
Cost of goods sold for the 3 months ended September 30, 2022 $27 million, compared to $30. 2 million for the corresponding era of 2021. In the 3 months ending September 30, 2022, Amarin continued the initiative it began last quarter to take steps to amend the supplier agreement, to align origin agreements with existing and long-term market demand, resulting in a rate of $3. 1 million this quarter. Renegotiating those deals is a very vital step in our strategy to hold money and decrease long-term stock purchases.
Excluding the effect of this item, gross margin was 73% for the three months ended September 30, 2022, compared to 79% in the third quarter of 2021.
Let’s move on to operating expenses. In the third quarter of 2022, we reported expenses of $68 million to $124. 9 million in the third quarter of 2021, a low of $56. 9 million or 46%. The effects of this quarter come with a restructuring rate of $4. 4 million similar to closing in Germany, and the third quarter of 2021 comes with a restructuring rate of $14. 1 million similar to that of the United States. Last year’s low is similar to the load relief projects that were announced in September 2021 and June 2022. These savings were partially offset by our investments in Expansion and Expansion in Europe.
Operating expenses were down by $38. 5 million or 36% compared to the current quarter of 2022. This is a minimum of $28 million compared to the current quarter of 2022, net restructuring fees and stock-based repayment expenses.
We began learning about the benefits of June charge discounts this quarter, and expect to continue to learn about those benefits through mid-2023, totaling $100 million in savings. expansion in Europe and other regions of the world.
Under US GAAP, Amarin reported a loss of $5. 1 million for the third quarter of 2022 or a fundamental, diluted loss consistent with a consistent percentage of $0. 01.
As of September 30, 2022, Amarin reported total money and investments of $306 million, demonstrating a particular decrease in money consumption compared to the last quarters of 2022. We have taken significant steps to strengthen the business operationally. We plan to continue to manage our liquidity prudently with respect to the company’s performance. As a result of recent operating projects and stabilized earnings trends in the U. S. In the U. S. , we have particularly reduced our burning of money and that our existing money and available resources, adding profitability in the U. S. In the U. S. , they are sufficient to support ongoing operations, adding launch activities in Europe.
I will now turn to Karim for his closing remarks. Karim?
Karim Mikhaïl
Thank you, Tom, for this monetary review and the effects of the third quarter. I am pleased with the effects of this quarter and so far this year. We have made great progress despite the many challenges.
As we look ahead to the rest of 2022 and early 2023, we will continue to ensure we remain financially strong, committed to driving our global expansion plans, with the launch materializing in Europe and proceeding to generate evidence globally for VASCEPA/VAZKEPA Diversity. And we remain focused on our ambitious vision of preventing cardiovascular disease from being one of the leading causes of death worldwide.
And with that, operator, we are in a position to answer questions.
Q&A session
Operator
[Operator Instructions]. His first consultation is from Michael Yee.
Michel Yee
I’m Mike Yee from Jefferies. We had two questions. First, congratulations on the United States. It turns out to be pretty stable, which is great. Guys, do you expect generics to keep coming in at some point as the deal opens or do you also have exclusive deals and liked the deals, which helps too. Can you remind me how this dynamic works in the United States?It gave us some visibility there.
And then, secondly, it’s about Europe. I know it’s implementing in certain regions and they’re coming. Can you describe how you expect the speed and, most importantly, investment to build there over the course of 2023?
Karim Mikhaïl
We will start with the first consultation on generics. As a reminder, this was a very generic launch sequence. We had one in October 2021, then we got one six months later and then the third came in the first quarter. Apotex was introduced in February, and we also saw Teva launch the 500 milligrams just two weeks after this last quarter. Therefore, we still see new generic participants.
Now, so far, Teva has only come in with 500 milligrams, which is 2% of the market. We will have to wait to see when they come, if they come, with 1 gram. I think what we can percentage is that even with 3 in the market, we have noticed that our prescription and earnings stabilize in the first quarter and in the third quarter of this year. Therefore, we remain attached to that. The scenario is dynamic. But having said that, we are confident that where we are today, we have stabilized profits. We lose on single-digit recipes and things progress as we planned.
Now, of course, we have to be in position for every scenario imaginable, right?We may have other occasions to come. And for this, we have several types of scenarios in position. We are in a position to opt for a legal generic and push the button, and replace without delay if necessary, and even other plans that we may have just put into effect in this case. But that’s for the U. S. U. S. We are confident that the scenario is strong so far and we are advancing our efforts with our effective core team in the United States.
Let us move on to Europe, as you have seen, we have had a constant repayment of values, positive decisions in Europe, have we not?We start with Sweden at $180 per month, or almost $2,000 per year. Then we had the United Kingdom, which is a much more complicated and complex system, which also accepted the same value. This quarter, we announced that a third country, Finland, also announced approval of this award. And just to give even more color and detail, Finland first of all rejected the dossier altogether, and we had to resubmit it from scratch, and still they gave us the courage we had asked Finland to adapt to the other markets. So things are progressing well.
You have also just learned that we have won a positive clinical evaluation from the Netherlands, we have won a positive evaluation from Italy and we are in the final value negotiations procedure in Spain. So needless to say, we’re rushing, however, things are moving in the right direction when it comes to value refunds.
At the same time, we’re now starting ad launches, us?We are starting ad launches in the UK and Sweden and things are progressing as expected and we believe we will be able to percentage some UK measures in the coming quarters to ensure all investors and shareholders are informed of our functionality in Europe.
Operator
Next is by Georgi Yordanov.
Georgi Yordanov
Georgi Yordanov of Cowen and Company speaks. Perhaps just to continue with the previous question. As far as generics go, do you have any idea why their percentage has stagnated around this 10% to 15%?And your renegotiated source deal you mentioned, does that offer more capacity for those generics?And then I only have one stick up.
Karim Mikhaïl
I don’t know which corporate you talked about in terms of generic percentage. Some of them are at 15%, others at least. The truth is that it is now an open market. And each generic pursues its business. So we don’t know why your percentage is where it is. We know what we’re doing, don’t we? What we do is concentrate entirely on logo promotion. We don’t invest a dollar to expand the molecule, which ends up going to the generic market, do we?So that’s what we’re concentrating on. We make sure we have a good offer for our plans, so they keep working with us because we have a sustained source with an effective load of goods. So that’s what we’re doing. And so far, as you can see, he’s painting, is he almost never like that?We are stabilizing erosion from a fair perspective. Quarterly, we’re at 60%, which is great.
Now what may happen tomorrow, look, for now our strategy is working. Is there enough source for generics? Of course, is there enough source?Right? So if there’s an estimate or assumption that generics aren’t promoted because they don’t have enough source, I can tell you that it takes 18 months to have a sufficient source. So we have more than 18 months. With generics on the market, there’s enough source beyond what everyone probably needs. Therefore, it is not a source query.
Now, with our agreements renegotiated, it was mandatory from the point of view of raising money, wasn’t it?And we see that the result and the very positive effect on our fundraising because it is an initiative that is here. to stay. So, it’s nothing that makes you eliminate burning money for a quarter, and then it will come back. Actually, this will be a solid situation. We have enough stock for the United States. And we don’t think the additional offer going to someone else can replace the story, because there was already enough source on the market before that. Therefore, it doesn’t actually replace the game.
Georgi Yordanov
My follow-up was, just when we think about the positive resolution and the upcoming launch in the UK, as if we were looking to perceive the duration of this express market, in particular, do you have any knowledge about sometimes, what percentage of pharmaceutical sales in Europe come from the UK?And how do we plan to increase there in terms of launch?
Karim Mikhaïl
The UK is definitely one of the five most sensible, it rarely is. You’re talking about a population of at least 70 million. It’s a big market. In general, it will regularly be number three, number four, depending on adoption, because it is a highly clinical market, by the way. Prescribers tend to be skeptical. And that’s a credit to us because we have evidence. So, it’s a deal we can do well from the start. So far, we can see that we are tracking more than analogues in terms of inclusion in the form. This is the maximum vital proxy that tells you the usage rate you will get because your product wants to be indexed and you want to be funded in the local form. So far, we are ahead of analogues. Therefore, it is a vital market. We are confident that this will be a vital launch. And again, we continue to prepare and will update in the next quarter with the results.
Georgi Yordanov
Congratulations on the progress.
Operator
Your next consultation comes from Roanna Ruiz.
Roana Ruiz
SVB’s Roanna Ruiz Securities. Je sought to know a little more about Germany and the arbitration decision. [indistinguishable] if you’re still on track to be on track for an update in mid-November?
Karim Mikhaïl
In Germany, the arbitration schedule is from mid to late November. As noted in previous disclosures, we have already taken all the mandatory measures to eliminate the burning of money in Germany at the end of a decision. In general, arbitrations do not usually result in a positive decision. Let’s be very real. This is usually a low probability of success. And if successful, there is usually the threat of reducing the price, which will have an effect on other markets.
The resolution we took, that is, mind you, we are going to suspend operations in Germany, was to protect the value in the United Kingdom, Sweden and Finland, the value we negotiate in Spain, as you can imagine, and other values such as the price of Germany as a country, let’s say that a giant market is 15% of the total of Europe, Isn’t it?So, if this country is going to give you 15% less than the average European, are you lost, ? So we’re not going to settle for a 15% decrease in value because so far we have a very constant approval value point at the European point, right?Realm Unido. De fact, it is only for the exchange. Actually, it is higher according to previous calculations. Actually, it’s for Germany and arbitration.
Roana Ruiz
Which makes sense. I would also like to review your fixed-dose combination charts for VASCEPA with a statin. And can we expect data or program updates later this year or in 2023?
Karim Mikhaïl
We are implementing this initiative very much. And you’ve noticed that we go to great lengths to keep our disclosures to a minimum because there’s a lot going on that we need to keep confidential until the right time. Once we are in a position to communicate, we will. So and it’s within the next two quarters that we’ll release an update. So, there’s a lot going on. It’s just that it’s not the right time to reveal it right now, however, the program continues and moves forward successfully.
Operator
His next consultation is from Louise Chen.
Carvey Leung
It’s Carvey for Louise Cantor. La first is, what do you think will be the biggest catalyst in the next 12 to 18 months?
The timing is about $100 million savings through mid-2023, can you elaborate on the speed of savings?Should we expect more savings at first, say, later this year or even more early next year?
And the last one is: you just headed the announcement launch in Hong Kong for a while this year, which is a separate track from China. Are there any updates here?
Karim Mikhaïl
I will answer the first question about the maximum vital catalyst. I think the most important thing is that we get the value refunded in some other big market. That’s literally what will drive shareholder value. The value we have in the UK is very positive. But I think the key question is, with the scenario in Germany and the demanding situations we face, can we achieve the same price and refund point in other, larger markets?And that’s very critical. And we are working to achieve this in the coming months, in the very short term, because we are in very active negotiations on values with the Spanish government. So, for me, this is one of the most important key steps.
Another would be for us to release an update to our fixed-dose suit. I think very little is known at the moment. And when we make it public, many shareholders will see the price this fixed-dose mix brings to the company in the short and long term. So it’s on a higher level.
Now, for the load saving and sequence, I’ll let Tom explain.
Tom Reilly
We’ve committed to achieving $100 million in savings by mid-2023. And look, for this quarter, we made about $25 million. So the way to think about that on a prospective basis for the next 3 quarters is within that diversity on a quarterly basis. Then we’ll hand over the $100 million.
I think the other thing to keep in mind, similar to how we stabilized our burning of money and operating expenses, we have been very well synchronized with our investments in Europe because we are receiving repayments. So as reimbursement comes in, obviously, the expenses adjust. And if it is not carried out on time, we will also adjust accordingly. Therefore, we are very cautious in this regard as we continue to keep our money flowing.
Karim Mikhaïl
And finally, in Hong Kong and China, as you know, Asia is still seriously affected by COVID. And things get started, they restart multiple times, and we’re in talks to see when is the most productive time to move forward with a launch. Hong Kong is a small market. Honestly, we’re focusing more on the biggest ones that will make a big difference in creating shareholder value. it is so important when we are active in Asia that we are active in territories because they synergize our efforts at the end of the day.
Operator
Your next consultation is from Daniel Wolle.
Daniel Wolle
This Daniel of J. P. Morgan. Karim, pointed to a possible $1 billion cutting-edge opportunity for Europe. Does this also mean a launch in Germany? And in Germany, you argued that in Finland, you were rejected, but you still controlled to get approval. You described a procedure through which you check to send an [indistinguishable] folder and restart again. So maybe you can give us a little bit of detail about what the procedure entails?And what kind of new clinical evidence can it provide to help cure gain the advantages of VAZKEPA?And I have a follow-up question.
Karim Mikhaïl
As far as Germany is concerned, yes, based on the levels of value and reimbursement we get in Europe, we see that we think the peak is over a billion dollars, right?Even without Germany, right?
Now, the way the painting goes is this. Lately we are in arbitration. We will have to wait and see how the arbitration award develops. There was a precedent in the German market where a product that obtained a negative resolution was returned and applied. In this case, they really used real-world evidence, knowledge for clinical benefit. I’m not saying that’s precisely what we’re going to do. But I’m just saying there’s a way. There is a very quick way to re-file a registration in Germany.
That said, the most important thing today is to concentrate on the other big markets, making sure that they give us back the value in Spain, making sure that they return the value in Italy and France, because that is what is going to generate the total value.
Daniel Wolle
With respect to generics in the US, beyond the origin issues, we’ve heard that API costs have become more competitive for generic manufacturers. Do you think this has an effect on the stability of VASCEPA?
Karim Mikhaïl
There was an era when values were stable. Then there was an era when stocks were volatile earlier this year. It is difficult to wait for how much value and if there will be any. To think that there will be worthwhile festivals in the future. If you have more generics, in theory, you’ll have more worthwhile festivals. And we have taken it into account in our corporate vision and in how we have sized our footprint.
I remind other people that a year later, our footprint was another 780 people. Today, our footprint is 75. Therefore, we are at a footprint of 10%. That’s why we believe we generate significant contribution margin in the U. S. In the U. S. , regardless of value or volume impacts. And if we want to, we have a generic legal plan in a position with a lot of source that is in a position to move to the market. And that’s why they saw us confident in ourselves coming out and saying We’re expanding our money flow track because we believe in whatever situation we find ourselves in. We will be able to get a source of income from Europe with our investments and with the contribution margin we get from the United States.
Daniel Wolle
And finally from me. Knowing that you haven’t revealed much about the fixed-dose combo, do you think you can provide a new patent profile to VASCEPA through the possibility in the US?USA?
Karim Mikhaïl
There is a patent consultation. But there is also a question about other protection. And today, let’s face it, this opportunity is going to be very, very critical for Europe, isn’t it?Because that’s where we communicate the billion-dollar opportunity. This is where we create shareholder value. Therefore, the maximum of our efforts is aimed at making sure that this will bring more opportunities to Europe, which I think everyone sees as moving in the right direction.
What you bring to the U. S. A lot will depend on how the generic market evolves when we launch a fixed-dose combination, which will be a few years or more from now. Therefore, it will basically concentrate on Europe and foreign markets. We’ll communicate more about that when we’re in a position to reveal more details.
Operator
[Operator Instructions]. His next query is from Paul Choi.
Paul Choi
Paul Choi with Goldman Sachs. A quick financial question for Tom, just one point of explanation about the $100 million in savings he expects until mid-23. How much of this represents the additional savings from the existing operating rate until closing?of operations from Germany?Can you quantify that?
Tom Reilly
How we disclosed it in the past and committed to it – the way we look at this is that we looked at the full year of 2021 as our base, which was about $450 million in operating expenses. We have committed the $100 million in savings we expect to see through mid-2023 based on this $450 million benchmark.
Paul Choi
I’m just trying to figure out how their closure in Germany resembles their 2021 base of that $100 million goal.
Tom Reilly
It’s built-in. It’s built-in. This is a component of overall investments similar to Europe.
Paul Choi
You talked about some additional partners for geographies where you’re not necessarily going to be trading directly in markets other than the United States. Can you give us a concept of when those associations or agreements will be finalized? And then how do you see the phased launch schedule in those foreign markets compared to the US?
Karim Mikhaïl
We seek to align partnership dates with regulatory approval dates because that’s where it really becomes critical. And for now, we’ve been talking and interacting with local partners in some of the largest overseas markets. We have interacted with regional partners in other regions, such as Asia or Latin America, but we also have interaction with global partners who can take multiple territories abroad and we are working very hard to align those approvals. We’re going to have approvals until the end of this year, some next year, and some until 2024. So, this is still a very sensible precedent because we believe it will only open up another source of profit without any fundamentally charge, no burden on our part. So it is definitely a precedence. And we’re going to announce anything until early 2023.
Operator
That’s all the time we have for questions today. I would like to move on to the Amarin control team for final comments.
Karim Mikhaïl
I just need to thank everyone. This quarter was very strong after the first and second quarters, with earnings stabilizing in the U. S. In the US, the fact that we are positive in terms of money restructuring fees and that we continue to make progress in repaying value in Europe and are now launching well in one of the largest countries. So, we thank you. And we look forward to talking in the next quarter and updating you on our results. Thank you all.
Operator
Thank you and gentlemen. This concludes today’s event. They can disconnect their phone lines right now and have a glorious day. Thank you for your participation.