Q3 2022 Amarin Corporation PLC Earnings Call
Welcome to Amarin Corporation's conference call to discuss its third quarter 2022 financial results and operational updates. This conference call is being recorded October 27th 2022.
I would now like to turn the conference call over to Lisa Defrancesco, Senior Vice President Investor Relations and corporate affairs at Amarin.
Good morning, everyone and thank you for joining us.
Be aware that this conference call will contain forward looking statements that are intended to be covered under the safe Harbor provided by the private Securities Litigation Reform Act.
Not achieve our goals carry out our plans or intentions or meet the expectations disclosed in our forward looking statements.
Actual results or events could differ materially so you should not place undue reliance on these statements.
We assume no obligation to update these statements as circumstances change our forward looking statements do not reflect the potential impact of significant transactions, we may enter into such as mergers acquisitions dispositions joint ventures or any material agreements that we may enter into a man determining.
For additional information concerning the risk factors that could cause actual results to differ materially. Please see the risk factors section 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 32022.
Which have been filed with the SEC and are available through the Investor Relations section of our website at Www Dot Ameren Corp Dot com.
Everyone to read these documents.
This call is intended for investors in Amarin and is not intended to promote the use of vascepa.
An archive of this call will be posted on <unk> website in the Investor Relations section creamy kill Ameren, President and Chief Executive Officer will lead our discussion and Tom Reilly Chief Financial Officer will provide a more detailed review of our third quarter 2022 financial results. After prepared remarks, we will open the call to your questions I remind.
You that multiple audiences typically listen to calls of this nature, including existing investors potential new investors employees current and potential collaborators and current and potential competitors as always in this call. We will attempt to provide constructive information without compromising our competitive and strategic positioning.
I'll now turn the call over to <unk>, President and Chief Executive Officer of Amarin Karim.
Thank you Lisa good morning, and thank you all for joining us today.
We began this year embarking on a bold strategy to grow and expand globally with.
We focused our three dimensional growth strategy breath, or geographic expansion height, representing diversification and depth or core operational evolution.
Now with 2022 needing a close and despite the significant headwinds and challenges faced earlier in the year. We are pleased to report that we made significant progress across our key priorities and we continue to achieve what we committed to.
Most importantly, we have turned around our cash burn levels as we strengthened our foundation through operational excellence strengthened our leadership team and laid the groundwork for a true transformation of Amarin in 2023.
I'm going to begin today by discussing the results of our cash preservation initiatives because I believe this progress is significant and critical to support our future growth and expansion plans.
There are two key initiatives that were central to our effort and the progress delivered.
First in June we took swift action announcing an extensive cost savings plan to reduce our operating expenses by $100 million.
Over 12 months.
These initiatives was comprehensive and involve cost reductions across the entire organization.
And we are beginning to realize these savings this quarter exactly as planned.
Beginning last quarter and as part of our company wide focus on operational excellence, we took steps to evolve our supply chain strategy and amend our supplier agreements to align supply arrangement with current and future demand within our U S business.
These initiatives, which Tom will discuss in more detail shortly have resulted in significantly lower cash burn quarter over quarter. In fact this quarter, we are cash positive excluding restructuring charges.
Also contributing to the improvement of our cash runway is the consistent stabilization of the U S revenue over the last three quarters. Despite continued pressure from additional generic competition.
We achieved this by focusing our core U S team efforts to sustain and support the Vascepa brand. Additionally, and as a result of the difficult decisions made at the right time to reduce commercial footprint in the U S. We remain highly profitable supporting future international growth.
As I look at our third quarter results and in the U S business I'm pleased to say our strategy is working.
In the third quarter of 2022, we recorded $89 9 million and total net revenue, including $87 $9 million in U S product sales largely unchanged from last quarter. Despite the continued pressure from generic competition and the restructuring effort we announced.
June which reduced our sales and marketing efforts and commercial footprint in the U S significantly.
This is now the third consecutive quarter with relatively consistent revenue performance. Despite continued generic competition, which is unprecedented in the industry and the third quarter performance was achieved with a more efficient footprint and resources, which speaks to the strength and efforts.
<unk> Ust.
Our steps to focus on promoting our brand are working.
Based on the latest prescription trends, we are maintaining current share at roughly 60% of the total IP market on a quarterly basis. We will continue to closely monitor the market dynamics in the U S and remain ready to adjust as necessary wherever possible.
With the stabilization of the U S business and the bolt cash preservation actions. We have speaking we have successfully extended our cash runway to ensure we can fund our expansion plans.
While I begin today's discussion with the recent actions dedicated to strengthening our financial foundation and preserving our U S. Revenues, we remain laser focused on our core future objective, which is global growth and expansion for Vascepa Vascepa in Europe and internationally as this is the.
Key to shareholder value creation.
122 has been about laying the foundation for our future across Europe , and we are now beginning to see this take shape before our eyes. We are now officially on the market and in commercial launch page in the U K and Sweden.
We recently received final positive national reimbursement in Finland, and Northern Ireland at a price in line with our recent UK pricing.
We also received individual reimbursement in Austria with a process underway for national reimbursement.
Although there are no set timelines in any of the remaining major markets. We are now negotiating reimbursement and are now in the advanced stages in all markets.
In particular price negotiations are nearing conclusion, with Spain's ministry of health, which could allow for possible pricing and reimbursement decisions. Shortly before the end of 2022.
In the Netherlands, we received a positive scientific assessment by the National Health care Institutes Zane for reimbursement and are beginning pricing negotiation with the Dutch Ministry of health.
Italy, we achieved a key milestone of a positive scientific assessment, allowing for our dossier to advance from the scientific assessment fees into the pricing and reimbursement negotiation fees with the Italian authorities.
Our strategy has always been around building a strong diverse and sustainable revenue stream in Europe .
This is why we have filed in 13 markets simultaneously since 2021 and are now in the mid to late stage reimbursement negotiations in France, Italy, Spain, the Netherlands and Norway.
This progress thus far and specifically the level of reimbursed net price. We have received acknowledges the value of escape and our ability to demonstrate this value to payers across Europe .
Turning to commercialization efforts in Europe .
In the U K, our launches underway since mid October and is progressing well and in line with our expectation based on our deep understanding of the market to.
To provide some context on the UK market and how it operates there are three distinct tiers of healthcare administration in England, NHS, England or the National Health services, which provides guidance on usage.
Next the integrated care systems are consolidations of organizations that planned for service delivery and funding the <unk>.
Final tier our local accounts with formularies, which lists the reimbursed product.
As you recall since receiving our final approval in July we have been following the typical process, while we await approval for public funding. We spent the first 90 days post approval focused on gaining formulary access to education medical and scientific engagement implementing formulary guidelines and bill.
<unk> awareness and adoption through multiple educational and commercial channel.
And we are simultaneously building a strong team in the UK as I mentioned earlier. This month public funding is now becoming available and we are transitioning to the commercial folks.
The number of formulary inclusion of Vascepa continues to track ahead of analogs and is improving weekly thanks to the clear stepwise approach to achieve both formulary listing and medicines pathway inclusion we are proud that vascepa is making its way as a new standard of care to reduce the risk of CV events beer.
Ldlc management in England, we will be updating investors with our UK performance to ensure everyone can keep track of our progress versus benchmarks over the next quarters.
Turning to the rest of Europe . We're also progressing in other major markets as well as continuing to advance our reimbursement discussions with national health authorities in Norway, Italy, France, the Netherlands, Portugal in Switzerland, where we have recently submitted and are now on file for reimbursement discussions.
We remain on track to receive reimbursement decisions and up to eight countries and to launch Vascepa in up to six European countries. This year and we remain confident that 2023 will be the beginning of strong sustainable revenue generation toward $1 billion plus peak opportunity.
In Europe , our truck.
<unk> continues beyond Europe , where we continue our plan to file in up to 20 countries through 2024, I'm pleased to say, thus far we have filed in 10 markets with the potential for a number of others before year end and into early 2023.
Specifically <unk> marketing authorization submissions for Vascepa skipper have been achieved in Hong Kong, Saudi Arabia, and Bahrain and applications remains pending and a number of other markets, including Australia, and New Zealand, which are continuing to advance for local procedures. We've also confirmed that our.
Regulatory filings are now actively under review in South Africa.
Africa and other markets. This is critical as we continue our search for the right partner in all those international territories, where we do not plan to build our own infrastructure.
Our current partners continue to make progress as well, including adding farm our partner in China recently stated that they have received confirmation that the Chinese government has completed the product testing and has initiated the final review period. Prior to approval. This final review began earlier this.
Month and has the clock of up to 67 business days.
Partner has communicated to us that they anticipate an approval could still be achieved before year end.
In Canada. The jealous Therapeutics, Inc has obtained reimbursement from all major public payers gaining access to the vast majority of eligible patients in Canada. They continue to be in the launch phase and the public sector.
We remain confident in the multibillion dollar global market opportunity.
<unk> of escape in Europe and internationally.
And we continue to invest in our data and evidence building of IP now with a global focus.
Following a leading presence at the European Society of Cardiology Congress over the summer we remain committed to maintaining a strong presence at important medical meetings, including the upcoming Canadian Cardiovascular Congress American Heart Association and the International Society for pharmaceutical outcome research in Europe .
As a premier Congress to discuss health care outcomes research. Our data was selected for presentation, demonstrating the cost effectiveness of vascepa in treating cardiovascular outcomes in the Netherlands.
Lastly, we continue to develop our fixed dose combination, which ensures our ongoing progress with this important program that combines vascepa with the staff.
To summarize our progress year to date, we are experiencing stable business trends in the U S. Taking important steps to preserve our cash our global expansion plans remain on track and we are continuing to focus on building deeper evidence and furthering our pipeline for the future with that I'll turn it over to Tom.
To talk more about our progress and strong results this quarter Tom.
Thank you Karim good morning, everyone.
I am pleased to report our financial performance for the third quarter of 2022.
I'm glad to note when excluding the $25 million in Q2 restructuring payments made in Q3.
Our cash positive in the third quarter of 2022.
Let me begin with our revenue performance for the third quarter of 2022, we reported total net revenue of $89 9 million, including net product revenue of $89 2 million.
A decrease of 37% compared to the third quarter of 2021.
U S product revenue was $87 9 million a decline of only $2 8 million versus the second quarter of 2022.
Collecting relatively stable trends in both volume and price.
Beginning last quarter, we are not investing to grow the IP molecule in the U S market, but are investing in sustaining and supporting the Vascepa brand and prescriber base, we have today in the U S.
We are pleased with our relatively stable trends, we expect volumes and price will continue to experience some pressure throughout this year and into next year.
The results included the international product revenue of $1 3 million, which includes European product revenue of <unk> 7 million.
Cost of goods sold for the three months ended September 32022 was $27 million compared to $32 million in the corresponding period of 2021.
During the three months ended September 32020 to Amarin continues to see initiative, which began last quarter to take steps to amend supplier agreements to align supply arrangements with current and future market demand, resulting.
Resulting in a charge of $3 1 million this quarter.
The renegotiation of visa agreement is a very important step in our cash preservation strategy and lowering our future inventory purchases.
Excluding the impact of this item gross margin was 73% for the three months ended September 32022, compared to 79% in Q3 2021.
Moving to operating expenses during the third quarter of 2022, we reported expenses of $68 million compared to $124 9 million in the third quarter of 2021.
Increase of $56 9 million or <unk>, 46%.
The results. This quarter include a $4 4 million restructuring expense related to the discontinuation of operations in Germany.
In the third quarter of 2021 included a $14 1 million restructuring charge related to the U S.
The decrease compared to last year is related to the cost saving initiatives that were announced in September of 2021 and in June of 2022.
These savings were partially offset by our investments in growth and expansion in Europe .
Operating expenses decreased $38 5 million or 36% versus the second quarter of 2022.
This is a $28 million decrease versus Q2, 2022, excluding net restructuring charges and stock compensation expense.
We began to realize the benefits of the June cost reduction this quarter and we expect to continue to realize the benefit to 2023 totaling a $100 million in savings.
The U S business continues to be profitable from a contribution margin perspective and provides all the necessary financial support for the expansion into Europe and other geographies around the world.
Under U S. GAAP Amarin reported a net loss of $5 1 million for the third quarter 2022, or basic and diluted loss per share of <unk>.
As of September 32020 to Amarin reported aggregate cash and investments of $306 million.
Demonstrating a significantly lower cash burn relative relative to earlier quarters in 2022.
We have taken significant steps to strengthen the company operationally.
We plan to continue to manage our cash prudently relative to business performance.
With the recent operational initiatives and the stabilized revenue trends in the U S. We have significantly lowered our cash burn and believe our current available cash and resources, including U S profitability are adequate to support continued operations, including European launch activity.
Yes.
Now I will turn the call back to cream for closing remarks Karim.
Thank you Tom for that financial overview, and our results during the third quarter.
Pleased with the results this quarter and thus far this year, we have made a great deal of progress despite the many challenges.
As we look to the remainder of 2022 and into the early part of 2023, we will continue to ensure we remain operation really strong from a cash perspective.
Dedicated to driving our global expansion plans with the lunch materializing in Europe , and continuing to build evidenced globally to support Vascepa skipper.
And we remain focused on our bold vision to stop cardiovascular disease from being a leading cause of death worldwide and with that operator, we are ready to take questions.
Ladies and gentlemen, the floor is now open for questions.
Any questions or comments. Please press star one on your phone at this time.
We ask while posing your question you. Please pickup your handset listening on speaker phone to provide optimum sound quality.
Please hold while we poll for questions.
Your first question for today is coming from Michael.
Please announce your affiliation then pose your question.
Hey, good morning, Karim, which Mike Lee from Jefferies can you hear me.
Hi, good morning, Mike.
Great.
Questions.
First congrats on the U S. It looks to be quite stable.
Which is which is great but can you remind me do you guys expect continued generics to come in at some point of supply opens up or do you also have exclusive.
Contraction preferred contracts, which is also helping can you remind me how that dynamic works in the U S that would give us some visibility there and then secondly is on.
Europe .
I know that you're working on different regions and Theyre coming on can you just describe how you expect the cadence and importantly, the investment spend.
To grow there.
As you get through 2023, thank you.
Thanks, Mike So we'll start with the with the first question with regards to generic.
Just.
To remind there.
This was a very unusual generic launch sequence.
Had one in October of 2021 than we've had one six months later than the third one game in Q1 2022 <unk> launched in February and we have also seen Teva launched the 500 milligram just two weeks of this last quarter. So we still see.
<unk>, new genetic entrants now so far they've only came with the 500 milligram, which is really 2% of the market will have to wait and see when they come if they come with the one Gram I think what we can share is that even with three on the market.
We've seen a stabilization of our prescription.
Our revenue in the first second and third quarter of this year. So we don't we keep tracking this the situation is dynamic.
But having said that we feel confident that where we stand today, we did stabilize the revenue we are losing.
Low single digit in prescription in.
Things are progressing as we planned them.
Now of course.
We have to be ready for any possible scenario right we could have.
Events coming up and for that we have multiple sort of scenario is ready we are ready to go for an authorized generic and press the button and immediately immediately switch if we need be and even other plans.
That we could implement in that case, but that's that's for the U S. We feel confident the situation is so far stable and we continue we continue our efforts with our core efficient team in the U S.
Moving on to Europe as you've seen.
We have had consistent pricing reimbursement positive decisions in Europe , right, we started with Sweden at the price of $180 per month almost 2000.
Annually than we've had the UK, which is far more sophisticated more complex system that also agreed to the same price.
This quarter, we announced a third of the country, which is Finland announcing also approval for this price adjust.
To give even more color and detail, Finland. Initially rejected the five completely and we had to re submit from scratch and we still got the price we add four from Finland aligned with the other markets. So things are progressing well you've just heard also that we we received a positive.
Scientific assessment from.
The Netherlands, we received a positive assessment from Italy, and we are in final price negotiation in Spain. So.
I don't want to say with accelerating but things are progressing in the right direction with regards to pricing reimbursement at the same time, we are starting now commercial launches right. We're starting commercial launches in the U K.
And in Sweden, and things are progressing as planned and we believe we will be able to share.
Some key metrics in the next quarters to ensure that.
For all investors and shareholders are updated with our performance in Europe .
Thank you. Thank you. Thank you.
Your next question is coming from George yard <unk>. Please announce your affiliation and pose your question.
Alright. Thank you so much for taking our questions. This is Georgia.
<unk> <unk> company.
Maybe just to follow up on the on the previous question just on the.
On the generics do you have any.
Idea or thoughts around like why their share has plateaued around that 10% to 15%.
And your re negotiated supply agreements that you mentioned.
Does that kind of maybe provide additional capacity for those generics.
And then I just have one follow up.
I don't know, which company you really quoted as two flat in terms of genetic share I mean, there is some of them are at 15 some are at less.
The reality is.
This is now an open market and in every every generic is going after its business. So we do not know why why their share is where it is we know what we are doing right. What we are doing is we're fully focused on brand promotion, we're not investing.
A dollar.
Two grow the molecule, which ends up going to generic business right. So that's what we're focusing on we're making sure we have an appealing offer to our plants. So that they continue to work with us because we have a sustained supply with efficient cost of goods. So that's that's what we are doing and so far.
As you can see it is working right. We are stabilizing the erosion from a share perspective on quarterly basis, we are at 60%, which is great now.
What can happen tomorrow look for at the moment our strategy is working we continue to monitor.
Is there enough supply for the generics you bet. There is enough supply right. So if there is an estimate or an assumption that generics are not selling because they don't have enough supply I can tell you it.
It takes 18 months to have enough supply. So we've been beyond the 18 months with generics on the market there is enough supply beyond what anybody probably needs.
So.
It's not a question of supply now with our renegotiated.
Arrangements.
This was necessary from a cash burn perspective right.
<unk>.
When you see the result, and the very positive impact on our cash burn because that's you know.
That's an initiative that's here to stay so this is not something that you do that in a way you eliminate the cash burn for a quarter and then it is going to come back in reality. This is going to be a stable situation. We have enough inventory for the U S and we don't believe that the extra supply.
That's going to anybody else can really change the story because there was already in.
Supply on the market, even before that so that's not changing really the situation.
Thank you.
Actually very helpful.
And then my follow up was just as we think about the.
The positive decision in the upcoming launch in the U K.
It's kind of like as we try to understand the size of that specific market. In particular do you have any kind of like data on usually what percentage of pharmaceutical sales in Europe come from the UK and how should we be thinking about the ramp up there.
In terms of the launch.
Yeah. So the UK is definitely one of the top five right Youre talking about a population of close to $70 million.
No.
A big it's a big market in general it will usually be number three number four depending on the uptake because it's a highly scientific market by the way.
Prescribers tend to be skeptical and that's an advantage for us because we have evidence. So we believe it's a market that we can do well early on so far we can see that we are tracking better than analogs in terms of formulary inclusion. That's the most important proxy that tells you how much uptake youre going to get.
Because your product has to be lifted and has to be funded on the local formulary. So far we are ahead of.
Analogs. So it is a significant market. We are confident that this is going to be an important launch and.
And again, we continue we continue to prepare and we will update over the next quarter with the results.
Thank you that's very helpful and congrats on the progress.
Thank you.
Your next question for today is coming from Orlando Ruis. Please announce your affiliation then pose your question.
Hi, Yes, Ron <unk> SUV securities Good morning, everybody.
I wanted to check in.
Second a little bit about Germany, an arbitration decision was curious if you still expect to be on track for a November update there.
Yes, so on Germany, the timing of the arbitration is mid mid to end of November .
As as you've seen from prior disclosures.
We already took all the actions needed basically to eliminate cash burn in Germany waiting for a decision in in general Arbitrations, usually do not.
Lead to a positive decision, let's be very real.
That's usually a low probability of success and a few succeed.
Which is to say look we're going to suspend the operations in Germany.
First to protect the price in the U K, and Sweden, and Finland, the price with negotiating in Spain, as you can imagine and other prices because the value of Germany as a country lets assume that a large market is 15% of total Europe right. So if that country is going to give you.
Our price, 15% less than your average European you are at a loss right.
We are not going to accept a price less 15, because so far we have a very consistent approval pricing level at a European level right. I mean, if you look at our Finland price I mean, it looks today, maybe just slightly lower than the U K in fact, it's only because of exchange in reality it is higher.
Based on <unk> calculation so.
That's really for Germany and arbitration.
Got it that makes sense and I also want to check in on your fixed dose combination work for Vascepa with a statin.
Any updates on how that's progressing and could we expect any data our program update later this year into 2023.
Yes, so we're working very hard on this initiative and you've seen that we're making a lot of effort to keep our disclosures to a minimum because.
There is a lot of a lot going on that we need to keep sort of confidential until the right moment once we will be ready.
To communicate we will and it is over the next.
A quarter or two that we are going to come up with an update so there's a lot going on it's just that it's not the right time to disclose that at this stage, but the program continues and progressive successfully.
Understood. That's helpful. We'll keep watch for that thanks.
Thank you everyone.
Yes.
Your next question for today is coming from Louise Chen Please announce your affiliation and pose your question.
Hi, Good morning, everyone. This is carvey on until we use from Tanner. Thank you for taking my questions. First question is what do you expect to be the biggest catalysts in the next 12 to 18 months.
Second question is on the 100 million cost savings too.
Mid 2023 can you speak more about the pace of the saving realizations should we expect more savings to be realized early on.
Later this.
This year or beginning of next year and our last question is just kind of the commercial launch in Hong Kong for some time this year.
Which is a separate track with China.
Updates here. Thank you so much.
Alright, thank you.
So I'll take the first question about the most important catalyst I believe the most critical one.
For us to achieve pricing reimbursement in another large market.
This is really what's going to drive shareholder value.
The price that we have in the UK is very positive, but I think the key question is.
With the situation in Germany, and the challenges we faced can we actually achieve.
The same pricing and reimbursement level and all of the other larger markets.
And that's a very critical one and we are working to deliver on this over the next few months.
In the very near term because we are in very active pricing negotiation with the Spanish government. So to me that's one of the most critical.
Key milestones another one would be that we come out with an update on our fixed dose combination I think theres very little known about this at this stage and when we will go public with this I mean, many of the shareholders will understand the value that this fixed dose combination really brings short and long term.
For the business. So that's really at a high level now for the question on cost savings and sequence I'll leave Tom sort of give more.
No detail on that sure. Thanks coffee for the question.
So we have got we committed to a $100 million of cost savings through May of 2023, and you will see for this quarter, we realized just about approximately $25 million. So the way to think about this on a moving forward basis over the next three quarters.
Is within that range on a quarterly basis. So we'll deliver the $100 million I think the other thing just to keep in mind related to how we stabilized our cash burn and our operating expenses, we've been really timely with our investments in Europe as were getting as were getting reimbursement. So as reimbursement comes in obviously the spend.
We will adjust.
And if it doesn't come in on the time, we're expecting then we'll adjust accordingly as well so we're being very prudent on that as we continue with our cash preservation.
And finally on Hong Kong and China as.
As you know.
Still by the way severely impacted by Covid and things sort of start to restart and multiples and we and we are in discussions to see what is the best sort of moment to go ahead with the launch Hong Kong is a small market honestly, we're focusing more on the larger ones that will make a big difference and creating shareholder.
The value and as you've seen from our disclosures we put in a lot of information about updates on filing in other Asian markets, because because we believe it is so critical when we are active in Asia that we are active in multiple territories because they do.
Synergize our effort at the end of the day. Thank you for the question.
Thank you so much.
Your next question for today is coming from Daniel Please.
Please announce your affiliation then pose your question.
Daniel from Jpmorgan. Thank you for taking my questions.
You highlighted a potential peak opportunity of $1 billion for Europe does that assume launch in Germany as well.
And within Germany.
I've mentioned that Finland, you got rejected but then you still managed to get approval.
<unk> outlined a process by which you can you are you trying to submit that dose here.
For that reason to put up positive restart again, so maybe can you give us a little bit detail on what the process involved and what type of new clinical evidence can you provide to support the therapeutic benefits of basketball.
And I have one follow up for questions.
Okay.
So with regards to Germany, yes, we confirm based on the pricing and reimbursement levels that we are getting in Europe . Today that we believe that the peak is upwards of $1 billion right, even without Germany right.
Now the way the way it's going to work is the following.
We currently today.
In arbitration.
We will have to wait to see how the arbitration decision goes data has been one precedent on the German market with a product that received a negative.
It.
A decision that went back and applied in that case, they actually use real world evidence data to support the clinical benefit.
I'm not saying this is exactly what we're going to do but that's I'm just mentioning that there is a path that is a very specific path to resubmitting, a filing Germany, having said that you know the most important part today is to focus on the other larger markets, making sure that we get pricing reimbursement in Spain, making sure we get pricing reimbursement.
In Italy, and France, because because thats really whats going to drive the value.
Overall.
Got it makes sense.
And then in terms of generics in the U S beyond supply issues, we've heard that pricing of Apis have become more competitive but the generic manufacturers.
Do you believe there is any impact from that on the stability of Vascepa.
Look I mean.
There was a period where pricing was stable.
Then there was a period that pricing was unstable beginning of this year.
So it's difficult to predict right.
At what price and whether that will be but look it would be unreasonable not to think that there will be future price competition right. If you have more generics theoretically youre going to have.
Price competition, and we have taken that into account and the way we look at the business and do we sized our footprint I remind people that a year ago, our footprint was 780 people today.
Today, our footprint is 75, correct. So we audit that 10% footprint. So that's why we believe we are still driving significant contribution margin from the U S. No matter, what the price impacts our ore volume impacts are and if we need to we have an <unk>.
Generic plan ready with a lot of supply that's just ready to go to the market. So and that's why you've seen us confident in coming out and saying we are extending our cash runway because we believe in whatever scenario, we're going to be we will be able to get to revenue from Europe with our investments and with the contribute.
Margin, we're getting from the U S.
Got it and last question from me understanding that you haven't disclosed much about the fixed dose combo.
Do you believe you can provide any new patent profile to vascepa by any chance in the U S.
So you know.
There is a question of patent but there is also a question of other protection and today, let's face. It this opportunity is going to be very very critical for Europe right. Because this is ware.
We're talking about the $1 billion opportunity. This is westwood, creating shareholder value. So most of our efforts are really making sure that that's going to add additional right opportunity to Europe , which I believe everybody is seeing moving in that direction, what will it provided to the U S will depend very much on where the genetic market is going to be when we can.
Come out with a fixed dose combination right, which is going to be.
<unk>.
A couple of years or more from now so.
This is really going to be focused mainly on Europe and international markets and we're going to talk more about it when we are ready to disclose more details.
Great. Thank you very much thank you Nate.
Once again, if there are any questions or comments. Please press star one on your phone at this time.
Your next question for today is coming from Paul Choi. Please announce your affiliation then pose your question.
Hi, Thanks, Paul Choi with Goldman Sachs.
A quick financial question for Tom just one point of clarification with regard to the $100 million in savings that you're targeting through mid 'twenty three how much of that is incremental savings from the current run rate versus the discontinuation of operations from Germany can you quantify that for us.
Sure Paul Thanks for the question.
So the way we previously disclosed we are committed to the way we look at this as we looked at the <unk>.
Full year of 2021 is our base growth.
<unk>, which was approximately $450 million of operating expenses. So we've committed that $100 million of savings that we anticipate through mid 2023.
It will be based off that $450 million benchmark.
Yes.
Okay.
Well I'm just trying to understand how much is like from you.
Our discontinuation of operations in Germany versus your 'twenty, one base off that $100 million target.
It's baked in.
It's baked in it's part of the overall net investments relate to Europe , okay. Okay, great. Thanks for that.
Then a follow up for Craig you talked about some additional partners.
For geographies, where youre not going to necessarily be directly commercializing joy.
<unk>, South and ex U S markets.
Can you, maybe just give us a sense for as to Windows.
Thanks, Paul So we are trying to align the dates of these partnerships with the dates of the regulatory approvals right because thats really when it becomes critical and for the moment, we did discuss and engage with local partners in some of the larger markets internationally.
We did engage with regional partners in other regions like Asia, or Latin America, but we're also engaging with global partners that can take multiple territories at.
At an international level, and we're working very hard to align those approvals we are going to have some approvals by end of this year. Some next year and some 2024. So that continues to be a top priority because we believe that that's just going to open another revenue stream with no basically cost no.
On our side, so it's definitely a priority and hopefully we will be announcing something by by early 2023.
Okay. Thank you very much for taking our questions.
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That is all the time, we have for questions today, I would like to turn the floor back over to the Amarin management team for closing remarks.
So I just wanted to thank everyone. I mean, this has been a very solid quarter coming up from <unk>.
Q1, and Q2 with the U S revenue stabilization. The fact that we are cash positive excluding restructuring charges and we continue to make strides in pricing reimbursement in Europe and now launching effectively.
And one of the largest countries. So we thank you and we look forward to speak in the next quarter and to update you on our results. Thank you all.
Thank you ladies and gentlemen, this does conclude todays event you may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.