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Amarin Announces Vascepa® (Icosapent Ethyl) Approved to Reduce Cardiovascular Risk in the Kingdom of Saudi Arabia (KSA)
https://www.nasdaq.com/press-release/amarin-announces-vascepar-icosapent-ethyl-approved-to-reduce-cardiovascular-risk-in
SCOTUS rules unanimously in favor of Sanofi and Regeneron in PCSK9 patent spat with Amgen:
https://endpts.com/breaking-scotus-rules-unanimously-in-favor-of-sanofi-and-regeneron-in-pcsk9-patent-spat-with-amgen/
Interestingly that VKTX traded over 62M shares when it released VK2735 phase 1 data and only traded 14M shares today. I am slightly surprised the stock closed near the high of the day and broke a long-term resistance of $24, as most traders use data release as a selling opportunity. I think it bodes well for the stock to continue to hold its uptrend.
Capt, thanks for posting. Can you or Lizzy forward this to Denner? They might not know. TIA.
Aaron Berg
Thank you, Lisa. Good morning. And thank you everyone for joining us today. Thank you, Lisa. Good morning, and thank you, everyone, for joining us today. I want to start by saying I'm truly honored to lead Amarin during a time of significant transition.
Turning Amarin back into a growth story as quickly as possible is what I'm focused on and what I believe will create shareholder value and working with a tremendous sense of urgency and the entire team is focused on driving tangible results.
I made the choice to step forward with the support of our new Board to serve in this role for a number of reasons. First, my history with this company. I've been with Amarin for more than 10 years now, serving predominantly in my role as Head of the U.S. business. Together with my talented resilient colleagues here at Amarin, I have experienced many ups and downs, and I've come to care deeply for the company, its people and the patients we serve collectively, and I remain committed to continuing this journey.
I believe in our product and our data. We have a tremendous asset in VASCEPA and VAZKEPA, supported by a wealth of data, particularly the REDUCE-IT trial. Third, I truly believe in our mission to help stop cardiovascular disease from being the leading cause of death globally. And lastly, I believe in the significant value of the opportunity that we have to introduce as many patients as possible to VASCEPA and VAZKEPA around the world, where there remains significant unmet need in cardiovascular disease.
There are millions of patients who can benefit from our product, and we have a real opportunity to make a difference in their lives. The focus on cardiovascular disease prevention is a priority for health care providers, patients and the investment community because even today, it remains a leading cause of death in many markets around the world.
While I've been a member of the leadership team for many years, my focus has been predominantly on the U.S. commercial side. And I'm proud of how we are maneuvering while faced with a very difficult situation in the U.S. and we'll summarize where we are at the moment there.
My focus now is on deepening my understanding of the area of business where I have not had any involvement, which is our European efforts. And since my appointment two short weeks ago, I immediately go right in and spent time with our teams in both Dublin and Switzerland to better understand and evaluate our progress. I look forward to working with the teams cross-functionally to share our many learnings and best practices across the organization.
2023 for Amarin so far has been marked by unprecedented change and evolution. This was driven by a number of factors, including the addition of an entire set of new Board members and the appointment of myself as Interim President and Chief Executive Officer. The new Board and leadership team of Amarin have been working together collaboratively on a regular basis as we rapidly evaluate the path forward for the company.
In my view, our near-term strategies are simple. We need to continue to efficiently generate substantial profit in the U.S.. In Europe, we're not where we need to be and must immediately work with the team to find ways to accelerate our activities. This means looking at ways to accelerate our revenue growth, where we've launched and finding a way to accelerate our pricing and reimbursement access where we still are in negotiations. And we have to do all of this while maximizing cash. This means scrutinizing our spending and implementing additional opportunities to save as we aggressively drive our business.
Europe is a difficult macro environment right now with many of our target markets experiencing economic challenges that impact reimbursement for innovative medications like VASCEPA. With consideration given to these conditions, the strong European team agrees, we are still not where we hope to be. And I can say, together, we are determined to rapidly identify positive adjustments and execute any additional actions possible to accelerate the pace of progress there.
We're doing this with a sense of urgency while also scrutinizing very heavily every dollar that we spend. We have a talented team in Europe with strong expertise. Together with my background and experience with VASCEPA and REDUCE-IT over a number of years, with the opportunities and challenges our team has faced in the U.S., I believe we'll be able to introduce new perspectives and perpetuate some new thinking and fresh ideas. I'll continue to focus on operational excellence in partnership with Tom and the rest of the team as we drive positive progress while scrutinizing investments and preserving cash.
Now moving to our business update for first quarter of this year. We reported a solid quarter of stable revenue and lower expenses. This was driven by our business in the U.S., which continues to remain stable. We did experience typical brand dynamics that occur between the fourth quarter and first quarter.
We saw volumes decline modestly as expected, but our exclusive contracts with many of our major customers remain intact, and we were even able to improve favorable access at a major plan, which attests to the strong work of our talented team.
While Teva, the fourth generic available has listed both the 0.5 gram and the 1 gram for a number of weeks, we have not yet experienced any significant impact from their launch. We've also seen the approval of a potential fifth generic, which has not yet launched.
While our U.S. team remains determined to continue to drive revenue by maintaining brand and volume, we stand ready to execute a number of different aggressive scenarios moving forward at the right time, which would ensure we retain our leadership in the IPE market. These scenarios are centered around preserving our profitability and, of course, our cash.
Moving to Europe. The teams are continuing to work smart and hard in a challenging environment. We reported $100,000 in net revenues this quarter, reflecting very early revenues from the U.K. In the U.K., as a reminder, we received final NICE guidance in July of 2022, funding allocation in October, which allows you to begin the process of gaining access to regional formularies and an update to the national lipid guidelines, including VASCEPA, was published in November of 2022, which has been a significant achievement of the local team so quickly after NICE guidance.
And the team is making solid progress with access to the market in England and Wales, and that will continue throughout the year. Once you have achieved a good portion of that full access, growth in this market tends to accelerate in a more meaningful way.
As we look to the rest of Europe, in Sweden, we're evaluating opportunities to accelerate performance, and we now have Finland with national reimbursement, which could help us drive prescription growth in this region.
Our pricing and reimbursement processes in other markets where we filed or remain underway. The objective of our commentary is to provide you with an update based on where we are today as these processes are often difficult to predict. The team continues to navigate through the unique pricing and reimbursement processes in Spain, Italy and France.
In Spain, we've completed a third round of negotiations, which is not uncommon in this market, and the process is ongoing. The next step is another round of negotiations expected in the near term.
In Italy, the team is anticipating additional feedback and minutes from a recent round of negotiations in order to determine the best next steps. The process in France is difficult, and we don't expect a decision this year. In the meantime, we're managing the process diligently as we continue to build scientific support. Within the U.K. in Scotland, we expect to receive feedback shortly with some anticipated additional work needed over the coming weeks to finalize the process there.
Overall, what I've learned in recent weeks is that these processes are not easy that they are complex and do not have consistent structure nor time lines. In addition, the macroeconomic context is unprecedented in Europe and many companies and assets are facing similar challenges.
Regardless of these challenges, we're here and accountable to drive and deliver tangible results. Our path to get there in Europe is to look at ways to do things differently and urgently in both our pricing and reimbursement efforts and our launch efforts. We're looking at everything through a fresh lens across the business to drive results and deliver value.
Our team in Europe has recorded important reimbursement successes to date, but there's a long way to go. The teams on the ground in these markets are working tirelessly, and they are not afraid to utilize learnings to take different approaches that can resonate with the pricing and reimbursement authorities. I support and I'm working closely with them to help accelerate our progress immediately.
In our markets outside of Europe, we received approvals this quarter in New Zealand and Israel. The recent approval in New Zealand follows the earlier approval in Australia in November of 2022, and we recently announced a partnership agreement with CSL Seqirus, who are well positioned to support the pricing and reimbursement efforts in this market, particularly with their strong record and successfully supporting pharmaceutical benefits listings and eventual marketing and promotion for VAZKEPA and help us deliver this important medicine to patients in these countries. And we're pursuing other partnership discussions in Southeast Asia to expand access to VASCEPA and VAZKEPA in this region.
In summary, I'm working closely with the Board and with a tremendous sense of urgency as we focus on turning Amarin back into a growth story because I believe that, that is what will create shareholder value. We know that this value will come from generating revenue and doing so with tremendous urgency. That's our focus. We're listening to and we appreciate the input from our important [ph] retail and institutional shareholders. I'm committed to keeping the market informed as we evolve through this transition period.
With that, I'll turn it over to Tom to talk more about our progress and strong results this quarter. Tom?
Tom Reilly
Thank you, Aaron. Good morning, everyone. I am pleased to report additional details on our financial performance for the first quarter of 2023. Let me begin by discussing our revenue performance.
For the first quarter of 2023, we reported net revenue of $86 million, including net product revenue of $84.7 million, a decrease of 10% compared to the first quarter of 2022. U.S. product revenue was $82.3 million, reflecting lower TRx volume and net price with a benefit in channel trade inventory, which normalized after Q1 2022 when the third generic entered the market. Compared to Q4 2022, U.S. revenue was down by 7%, primarily due to lower TRx volume.
We remain pleased with the performance in the U.S. despite of multiple competing generics on the market. The U.S. business continues to provide profit in supporting our expansion into Europe and other geographies around the world.
The revenue results included European product revenue of $0.4 million compared to $0.3 million in Q4 2022, reflecting very early revenues from the U.K. We recognized $1.3 million in license and royalty revenue in Q1 2023, including $0.5 million related to the onetime payment associated with the CSL Seqirus license agreement for Australia and New Zealand.
Cost of goods sold for the 3 months ended March 31, 2023, was $38 million, which includes a $12 million onetime supply settlement expense. This compares to $22 million in this corresponding period of 2022.
Gross margin was 70% for the 3 months ended March 31, 2023, when you exclude the impact of the supply settlement this quarter. This compares to 76% in Q1 of 2022 as a result of lower U.S. net selling price and sales mix related to partner revenue in the quarter. Gross margin was stable when compared to the fourth quarter of 2022 when excluding the settlement charge.
Moving on to operating expenses. During the first quarter of 2023, we reported expenses of $65.3 million compared to $100.7 million in the first quarter of 2022, a decrease of $35.4 million or 44% when excluding stock compensation and onetime charges.
The decrease compared to last year is primarily due to the cost savings initiatives announced in June of 2022 and lower expenses in Europe due to the commercial withdrawal in Germany. Under U.S. GAAP, Amarin reported net losses of $16.5 million for the first quarter of 2023 or basic and diluted loss per share of $0.04.
As of March 31, 2023, Amarin reported aggregate cash and investments of $305 million. And excluding the supply restructuring payment, reported a cash positive first quarter of 2023. As of today, we are not seeing any significant impact from Teva's listing of a 1-gram generic version of VASCEPA. There has also been an additional approval of another generic sites [ph] at the end of April.
Absent any additional market disruption, we expect prescription levels to modestly decline for the remainder of the year and beginning in Q2, a decrease in our net selling price as we work to retain key customers to the brand.
We have continued to make progress against our cost reduction program. We are on track to exceed $100 million cost savings target we announced in mid-2022 and are currently evaluating additional potential savings.
For the full year 2023, we now expect operating expenses to be between $270 million to $285 million compared with the previous guidance of $290 million to $305 million. The lower-than-anticipated expenses are as a result of additional initiatives taken across the organization to reduce costs, along with the timing of our European investment where we committed to invest carefully in Europe, linked with the timing of reimbursement decisions.
We have taken steps to strengthen and streamline the company operationally and cost reduction efforts are ongoing. We announced another renegotiated supply agreement this quarter, making significant progress in lowering our future commitments. With these initiatives and the relatively stable trends in the U.S., we believe our current available cash and resources, including U.S. profitability are adequate to support our continued operations, including European launch activities.
With that, I will now turn the call back to Aaron for closing remarks. Aaron?
Aaron Berg
Thank you, Tom, for that financial overview and our results during the first quarter. As we look forward to the remainder of the year, our priorities are focused on a single goal, turning Amarin back into a growth story to create shareholder value.
While cost savings and cash preservation are essential, we can only deliver shareholder value by accelerating prescription growth in Europe, generating revenues and securing reimbursement in major markets, and that's our urgent focus right now.
I'm energized by my new role at Amarin. We have a strong team, and we have a great product that has the potential to benefit so many more patients around the world. I'd like to thank our employees for their commitment and for their support and look forward to making progress and delivering results together.
And with that, operator, we're ready to take questions.
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] Thank you. Our first question is coming from Michael Yee with Jefferies. You may proceed.
Unidentified Analyst
Hi, good morning. This is George Weah [ph] for Michael Yee. Maybe two questions for me. First one is what are the priorities of the company right now? And do you see M&A more likely seen support [ph] change? That's my first question.
And second one is, so you lowered your OpEx guidance further. And could you help us understand what the reduced spending is from and if they have anything to do with any delays or interruptions in the timing of reimbursement or approval for some countries because it sounds like there are some challenges in Spain, Italy and France?
Aaron Berg
Sure. First of all, thanks for the questions. And good morning. So I'll answer the first question, and I'll turn it over to Tom to address the question regarding lower OpEx. The priorities we're focused on are: one, we need to continue to efficiently generate substantial profit in the U.S. That's a primary focus, excuse me - the engine of the company, and it's helping us drive our results and activities in Europe.
In Europe, the priorities are, one, where we launched to drive revenue growth. We need to drive prescription volume, continue to execute very well and get the ramp up as rapidly as we can to reach patients and drive revenue. And then, of course, we need to advance the pricing and reimbursement discussions. We need to secure more commitments in more markets going forward.
And then we need to do all this and be very, very attentive to our cash. We've got to spend judiciously. We've got to spend at the right time, and that's a balance, right? That's a balance in Europe because we need to prepare the market, but yet we can't invest too early relative to when we get these pricing reimbursement, the access in those countries.
And the issue is, of course, we want to have the pre-market support when we launch for a faster ramp-up, but we don't control the timing of the pricing and reimbursement decisions. We control so much of that. We have to give them a reason to say yes, but the timing is not fully up to us. So that affects when we spend, but we're very attentive to that. It's a key priority. So it's - drive profits in the U.S., it's drive Europe and it's maximized our cash.
With that, Tom, do you want to address the OpEx question.
Tom Reilly
Sure. So the OpEx question was related to the change in the guidance and the lower of the guidance, which we're very pleased with. It's really twofold. First and foremost, as Aaron mentioned, just to reiterate, we're very focused on our cash preservation and trying to balance that with the focus on growth.
So the change in the OpEx guidance, the first component of it is we've really driven more cost reductions versus what we originally planned. So if you recall last year, in June of 2022, we had said we're going to have $100 million worth of savings. We're exceeding that target. We found additional cost synergies or cost savings within our sales and marketing organizations within G&A. Just one example, we renegotiated our administrative offices here. We're able to find a sublease partner. So really focusing on the optimization of the cost structure, which we're going to continue to look at as we're looking to preserve cash.
The second component of that is related to pricing and reimbursement. So our guidance was based on timing of pricing and reimbursement in specific countries. We always said we would be very judicial in our investments and waiting until we saw the pricing reimbursement coming through. And with that, we would do the investments at that particular time. So a component of our change in the guidance is a little bit of our internal delays on the timing of pricing and reimbursement, and that's what's changing our guidance.
Unidentified Analyst
Thank you. Could you be more specific about what countries are you looking at when you plan your budget in terms of more and more cost savings?
Aaron Berg
Sure. Tom, do you want to cover on the cost saving in it?
Tom Reilly
Yes. So again, it comes down to what we're - our timing for Europe. For the big countries, we're still focused on the reimbursement of the big countries, including Spain, Italy and Netherlands and some of the other countries for - in 2023. We have alluded that for 2024, we expect France to be during that time line. So the majority of the countries, excluding France, we're expecting a decision on pricing reimbursement within 2023. Does that answer your question?
Unidentified Analyst
Thank you. Yes.
Operator
Thank you. Our next question is coming from Louise Chen with Cantor. You may proceed.
Louise Chen
Hi, thank you for taking my questions here. So I wanted to ask you something that you had mentioned earlier in the call, you talked about turning Amarin back to growth. And I'm curious how long you think that will take? Or when do you expect to see that? And is that globally or in all the markets that you participate in?
The second question I had for you is on the international markets outside of Europe. Which ones are you most excited about? And how do you size those opportunities? And then last question here is I didn't see you mentioned a lot about expanding your product portfolio. I know historically, the other management team had talked about that, so curious on where you stand with those initiatives? Thank you.
Aaron Berg
Thanks for the question, Louise. So I'll address the first ones and then turn it over to - both to Tom and to Steve Ketchum, who's here with us to address the third question. So in terms of turning Amarin back to the growth story, we're really focused on primarily Europe. The U.S. will drive our profit, but you know we're in a unique situation here with generic competition. And the team has done an outstanding job. We still maintain 57% of the IPE market. And you see the revenue number here for Q1, which is a solid number given the fact that it's 2.5 years after generics have been introduced. So while the U.S. continues to be the engine, our growth and our biggest opportunity really is progress in Europe.
In terms of timing, that's very difficult to bridge [ph] As I commented on in the prepared remarks, the pricing reimbursement timing is a significant rate limiting factor and then, of course, launching into those markets and what the ramp-up will look like – excuse me, will know more when we get going.
In terms of the pricing reimbursement as well, remember, one of the big variables in the pricing reimbursement is which patient population we agree upon with those pricing and reimbursement authorities. And that will also help us value once we have commitments that will help us value exactly how big the market will be. So we'll have a better view as we secure more access in Europe.
And then - and obviously, globally, too, we have - and we'll just turn to Tom to talk about beyond the EU, some of the markets we have, some of the partnerships we have and where we see some of that opportunity.
Tom Reilly
Great. Hey, Louise, thanks for the question. So outside the U.S. and Europe, you asked [ph] about markets and what we're excited about. So obviously, you see that we signed an agreement for Australia and New Zealand with CSL Seqirus this quarter, which we're very excited about working with our partner there.
We're also excited about the opportunity with China. In China, as you know, we have a partner there, Eddingpharma, who is leading the regulatory review process. We're expecting based on the communication from Edding that we should be hearing about regulatory approval expected by the midyear of this year.
So those are two markets we're very excited about. Also other markets in Asia, we're excited about it as well. As you know, our strategy outside of Europe and the U.S. is to look for a partner. We're not looking to put an infrastructure in place related to outside of those - or in those geographies, I should say. So with that, related to the portfolio, Steve, do you mind just answering a little bit about the portfolio?
Steve Ketchum
Sure. Yes. So firstly, just continuing on the international regulatory front, obviously, cardiovascular disease is a major pillar of patients in all countries. So we continue to leverage our strong regulatory dossier that's been approved now in more than 30 countries globally, and we will continue to do that in a manner that is cost efficient.
In terms of our other portfolio, we continue to explore and conduct focused research activities and follow-on products and follow-on indications, but again, in a manner that maintains our focus on the strategy and goals that Aaron and Tom have shared in terms of making sure that also from an R&D perspective, we support U.S. efforts, getting accelerated traction in the EU supporting pricing and reimbursement activities as needed. And again, contributing to this company-wide effort to scrutinize our spending and implement additional opportunities to save as we aggressively drive our business.
Aaron Berg
Thanks, Steve. And then Louise, just to comment on M&A. That's not our focus right now. Our focus, our key priorities, as we said, are driving VASCEPA/VAZKEPA globally. We - as we commented on, we have significant opportunity, that's where we believe we will generate the most value, and that will continue to be our focus.
Louise Chen
Thank you.
Operator
Thank you. Our next question is coming from Roanna Ruiz with SVB Securities. You may proceed.
Roanna Ruiz
Great. Morning, everyone. So a couple of questions from me. I wanted to check in on latest updates with your progress on the local formulary negotiations in the U.K. and how that might impact VASCEPA sales going forward?
And then also, secondly, I wanted to ask about the renegotiation of supply agreements. I noticed you mentioned there's a $12 million charge. Curious if we could see additional charges into 2023?
Aaron Berg
Thanks, Roanna and good morning. So I'll address the first question and turn the supply agreement question over to Tom. In terms of local formulary negotiations in the U.K., making tremendous progress, I believe we have now say, I've been in the job two weeks but learning fast, and I believe we have over 90% coverage now.
So we would expect to start to see some accelerated prescription growth. The rate of that, we'll look forward to - as you know, we're very early in the launch there, very early in getting that access, but we'll look forward to prescription growth here coming up in the near term, and it should accelerate. Tom, do you want to address the supply question?
Tom Reilly
Sure, Roanna. Thanks for the question. So related to the supply agreements, this initiative started back in Q2 of 2022 when we saw the generic - the third generic impact related to the U.S. market. So overall, I would tell you these conversations are not easy conversations with our suppliers. These are very difficult to discussions we have with them.
We've made strong – good progress, significant progress. We have very good relationships with our partners. And so we need to look at the - we'll be looking at these arrangements with the partners. Related to timing of charges, a lot of it depends on negotiations or actually discussions related to pricing and reimbursement in Europe. So depending on how that goes based off of some commitments will determine the extent or if there are any other supply agreements necessary just from a restructuring perspective.
Roanna Ruiz
Great. Thanks.
Operator
Thank you. Our next question is coming from Jessica Fye with JPMorgan. You may proceed.
Unidentified Analyst
Good morning, guys. This is Nathan on for Jessica Fye. A couple of questions from me. In terms of your expectation for the fifth entrant of generic, how do you think that might impact pricing? And what do you understand to be their capacity?
And then secondly, I think Amarin has talked about the peak opportunity in Europe being $1 billion. Do you hold to that target? And can you remind us what do you think it's going to take to get to that $1 billion target? Thank you.
Aaron Berg
Thank you. Good morning. In terms of the fifth entrant that's a company called Zydus. And we don't have information on capacity, but we've seen this before where some of these generic companies list when they get approved, and there can be a very long time before they launched. We saw that with Teva and extended period. We also saw that with other - one of the other generic manufacturers, I think it took 10 or 11 months. I forgot whether it was [indiscernible] one of them also took an extended period of time.
So they were recently approved. This is a very complicated product to source and manufacture. So we monitor it very, very carefully. But in terms of the timing and the impact on pricing, we don't know yet, but we haven't seen an impact overall.
And we've got - and as I mentioned, Teva listed and launched several months ago and they have prescriptions just in the hundreds per week, which is in a market of 100,000 or so prescriptions a week.
So with that being said, it's 2.5 years since the generics were introduced. We continue to maintain 57% of the IPE market. We've maintained our exclusives. We actually even improved one of the major Part D plans, improved the access for VASCEPA here at the end of Q1. So we feel pretty good right now about our ability to maintain the business. But that being said, we monitor the generics very, very carefully, and we're prepared to react when we see a significant impact, we have other scenarios, including launching AG. So we're prepared with other scenarios. We can maintain profitability as much as we can in the U.S. for an extended period, whether it's in branded or through launching an authorized generic.
Regarding the $1 billion - regarding the peak sales in Europe of $1 billion, right now, our focus is on executing walk, you know, walk before we run. We are looking at every market at what happens with pricing and reimbursement, what happens with prescription uptake, what that looks like. In the pricing and reimbursement, as I said, it depends on the patient criteria and the size of the market that we have access to in each of these markets. And I think once we get going, we'll have a better read on the $1 billion.
So my preference, again, two weeks here in this role. I'd like to see - learn more. I'd like to see us make more progress. We know there's a significant opportunity in Europe that we know. And there may very well be scenarios to get us to north of that $1 billion. But we've got some work to do first, and I'd prefer to see how our progress is as we go to the end of 2023. Hopefully, that answers your question.
Operator
Thank you. Our next question is coming from Paul Choi with Goldman Sachs. You may proceed.
Unidentified Analyst
Hi. This is Kate Cruise on for Paul Choi. Thanks for taking our question. Thinking about the U.S. business, we wanted to know if you could put numbers around the positive contribution margins for the U.S. business and how margins there have trended over the last 12 months? And then also where you expect those to settle out on a more long-term view? Thanks so much.
Aaron Berg
Sure. Tom, do you want to comment on the contribution margin?
Tom Reilly
Sure. So overall, we don't give guidance or we don't disclose, obviously, contribution margin by region. What I can say is that it is driving significant profits to support the overall business. In addition, it's generating significant cash, including working capital manages to support our overall business.
It's obviously an important market for us to continue with our presence in even - in a generic environment. As Aaron mentioned before, we've developed multiple scenarios, right? And it's related - if there is - if there is an impact, and our focus is to continue to drive this profitability of cash in order to support the overall business.
Unidentified Analyst
Got it. Thanks so much.
Operator
Thank you. We have reached the end of our question-and-answer session. So I'll now turn the call back over to management for closing remarks.
Aaron Berg
So thanks again for joining us this morning. Thanks to everyone. And as I said earlier, I'm energized by a new role. We have a fantastic team here. I'm excited to work with them, and I look forward to following up and meeting - hopefully meeting many of you soon. Have a good day.
Competition highlights how biotech dealmaking has heated up:
https://www.bloomberg.com/news/articles/2023-05-01/abbvie-bristol-myers-vied-for-prometheus-before-merck-bought-it?sref=ZkFd9UXR
"On August 11, 2022, the Board held a meeting, with members of Prometheus management and representatives of Goldman Sachs and Latham in attendance, during which representatives of Goldman Sachs discussed current biopharmaceutical capital markets and M&A considerations, including recently announced transactions, and reviewed process and timeline considerations related to strategic partnering and financing opportunities for Prometheus. After the discussion, the Board authorized Prometheus to (i) explore potential strategic partnering and financing opportunities and (ii) taking into account a number of factors, including its familiarity with Prometheus, its reputation as an internationally recognized investment banking firm, and its substantial experience with respect to the pharmaceutical and biotechnology industries, engage Goldman Sachs as its financial advisor in connection with this review of strategic alternatives."
p-40-p45:
https://www.sec.gov/Archives/edgar/data/1718852/000119312523127473/d489453dprem14a.htm
Kiwi, I believe we both own stock in this space: VKTX. However, IMO, no drug beats Vascepa in efficacy/side effect ratio, GLP-1 agonists included.
"If the FDA confirms the drug’s effectiveness, a “fair” price for tirzepatide could be around $13,000 annually, or around $1,100 a month, said Dr. David Rind, the chief medical officer for the Institute for Clinical and Economic Review, a research group that helps determine fair prices for drugs."
I don't understand: insurance companies said it's expensive to cover Vascepa which cost less than $5000 a year but could reduce CVD by 25%.
https://www.nbcnews.com/health/health-news/weight-loss-drug-affordability-rcna60422
I believe it's too early for the fly to disclose as AMRN could go either way from here. TA means "To be Announced".
Your data points might be limited as you were not around this board long enough.
Kiwi, there are 3 possible reasons why eating oily fish are beneficial to cardiovascular health:
1) due to EPA
2) due to EPA + DHA
3) due to DHA
Only #1 above is supported by multiple clinical trials. If anybody rejected the idea of EPA being cardio-protective despite evidence of multiple clinical trials, one has to conclude eating oily fish is not beneficial to cardiovascular health.
Kiwi, are you saying eating oily fish such as salmon and sardine has no cardiovascular benefit?
JT should check himself into an "old age home" for single-handedly destroying the shareholder value of Amarin. He should be barred from being an officer of a publicly traded company forever.
J, our interests and Denner's interests are aligned. Denner just needs more time to improve shareholder value and make a profit from his investment.
tony, but the VK 2809 Phase 2B readout is only a few weeks away. Raising cash now might send the wrong signal.
Capt, correct me if wrong, I believe the probability of getting a favorable panel is less than 5%.
Dew, ETNB announced a $200M offering and the stock goes up 24%. Based on your experience, is there any correlation between a positive secondary offering reaction to subsequent stock outperformance? TIA.
After major fanfare in 2020 when Novartis and England’s National Health Service pledged to study the cholesterol-lowering drug Leqvio as a primary prevention med in patients with atherosclerotic cardiovascular disease, the company is changing course.
Under their prior partnership, Novartis and NHS England planned to study whether Leqvio could prevent the first occurrence of major cardiovascular events in U.K. patients with high cholesterol. Now, in part because of the pandemic, Novartis is changing the plan, Reuters reports.
“After careful evaluation, we have decided not to move forward with ORION-17, the UK-based primary prevention trial originally planned as part of the NHS England (NHSE) partnership,” a Novartis spokesperson told Fierce Pharma in an emailed statement.
The company will continue to study Leqvio in the high-risk primary prevention setting, the spokesperson said. A 14,000-patient trial in this indication kicked off in mid-March. That study is called the VictORION-1-PREVENT trial and it aims to enroll patients across 42 countries, including the U.S. and the U.K.
Under the Novartis and NHS England partnership, the pair also stipulated that they would provide the drug to high-risk patients at a discounted price in a world-first “population-level agreement.”
Novartis and England’s NHS remain “fully committed” to Leqvio and their partnership, the Novartis spokesperson said, noting that the drug “has already seen significantly faster patient uptake” in the U.K. compared with other similar drug launches.
“We continue to have very high ambitions for Leqvio and are encouraged by the foundation we have built and the traction we have seen so far, both in the UK and around the world,” the spokesperson added.
The U.K.’s National Institute for Health and Care Excellence (NICE) recommended the medicine in 2021.
https://www.fiercepharma.com/pharma/fewer-doses-could-be-ticket-for-novartis-cholesterol-lowering-leqvio-which-could-pull-2-5
ESPR has lost 37% of its value since the CLEAR outcome data (AMRN has lost 22% during the same period). There is no "money" in CVD medications. That's why CVD will remain the #1 killer forever.
Did Denner double his stake from 24M shares?
SVB was solvent two days ago and its investment portfolio is invested in MBS which if held till maturity will get its principal and interest in full. It's a just classic bank run that brought down SVB.
Won't shock me that even publicly traded biotech stocks might park some money with SIVB, hence the weakness in the market today, but they should get back their deposits eventually.
Silicon Valley Bank (SIVB) closed by regulators, insured deposits to be protected by FDIC
https://www.shacknews.com/article/134548/svb-financial-sivb-shutdown-fdic
Over 50% haircut to the 16th largest bank in the US would drag down most stocks, especially an orphan stock such as AMRN.
Today's weakness in AMRN is due to, believe it or not, SIVB, dragging down the whole market:
Banks tumble as SVB ignites broader fears about the sector,
https://www.reuters.com/markets/us/banks-tumble-svb-ignites-broader-fears-about-sector-2023-03-09/
Q - Georgi Yordanov
So I guess, to start, maybe we can just started with kind of like taking a step back and thinking about the European opportunity. Obviously, that is something that we at Cowen have for a long time being big believers in obviously, you're too. So maybe, can you can you help us frame that opportunity, the size of that market? And how should we be thinking about it?
Karim Mikhail
Sure. So the you know, the opportunity in Europe and internationally is really why most of us join Amarin, by the way, in the last two years is, because the company was at a time where we're losing the IP in the U.S., we understood how big that is. But we also knew from prior experience that we can recreate this potential in Europe and international.
So when you look in Europe, for example, you're talking about, you know, another 14 million statin treated patients, so not very different from the numbers in the U.S. If you look at how many of these, you know, have elevated triglyceride, more than 150 is probably a third. How many of these have established CVD, you can discount another 20%. So we're still talking in the millions of patients of patient potential in Europe. So it's definitely a very significant opportunity.
Georgi Yordanov
That's great. Your next question, maybe will be helpful to us, especially U.S. centric analysts is what is normal for a launch? What should we be expecting in terms of timelines? And as you know, whatever we've said in the past, or wherever we weren't, now we are here in from this moment, how would you frame out expectations and what it takes to get a product established and kind of going in a ramp?
Karim Mikhail
Yes, and the challenge here is, obviously Europe is very different than the U.S. Because what we're used to in the U.S, the minute you get the approval, you have the product ready, you launch immediately, you have your early managed care contracts in place, and you start selling the next day. And what happens is in two, three years, you start getting into the rebating, and the prior authorizations, because you sold a lot, the opposite almost happens in here.
So you take around maybe two years, on average, I'm saying in terms of pricing, reimbursement negotiations, depending on the country. But once you have that you basically have open, unrestricted access to the eligible patient population that you agreed upon. So you no longer go back to ask anybody for anything. A prescriber prescribes the patient fulfils its paid. And that's it. And you will literally have that for the life of the product, unless you have a price revision at Tier 3 or Tier 5.
So the pricing reimbursement Europe is the most critical gate to basically go through, when you have that at the right price level. You really built already 70%, I would say of the value of the product, because after that, it's a penetration issue. It's how good are you in getting physicians to prescribe. Now, we're talking about a very different prescriber base than the U.S. statin treated physicians in the U.S. like 700,000, right?
These are not the numbers you're dealing with in Europe, even in a country like France that has 70,000 GPS, you end up visiting 13,000 if you have the largest Big Pharma field force, why because the business is very concentrated. So you can actually be far more efficient at the European level. But still, it's a process that takes time. You cannot go from I have a label to pricing reimbursement next day to you're getting to your peak within just a few months.
Georgi Yordanov
And just another broad question before Georgi starts drilling down on some of the specifics. Remind us who you are, what you've done, because you just framed out Europe and we're talking Europe, so it'd be great to your background. And so we understand, you know, your expertise as you as we go into this launching attendee executed?
Karim Mikhail
Yes, so I'm a pharmacist by training. Most of my career, I have 22 years with Merck and company, lived and worked in seven different countries across three continents. My last three roles at Merck were, you know, Head of Global cardiovascular business, so U.S., European International, but before that Chief Marketing Officer in Europe and CEO of emerging markets so a third of my life in the U.S, a third in Europe and a third in international markets.
And throughout my career in the cardiovascular alone, we launched the ezetimibe franchise, we launched JANUVIA, JANUMET. We launched Cozaar, Hyzaar. And I even you know, even worked on Renitec in its latter days and it is great for me and for all of us to be working on a drug like the CPAP. I mean, it is not every day that you see a product delivering not 25, because in Europe, we are mostly on established at 30% relative risk reduction, three, zero.
Georgi Yordanov
And you know some of the things that is the evolution of launching a drug in the U.S. 15 years ago and 10 years ago and five years ago, and right now there's been an evolution payers are much more important. Is Europe a little bit more static, meaning what's happened 10 years ago and five years ago is fairly similar today, or there have been some nuances and differences you'd have to adapt to?
Karim Mikhail
It's been very dynamic. This is a very good question. Not only there have been changes in the last 10 years, there have been significant changes in the last two years. Why? People maybe forget that, you know, in Europe, medicine is paid by the government, right? Everything is subsidized by the government. There are no private insurances, right? There are no contributions that you pay to an insurance company.
It's deducted from your salary with your tax, your social contribution. And the government takes that money and basically pays us the pharmaceutical companies for the drug. So you're really negotiating with the government, one single payer, on you know, the future of your drug. And the challenges in the last two years, is that most of these governments have been under incredible budgetary pressure, where a country like Germany.
And you know, we've had a challenge in Germany, like many other companies, they've basically had a healthcare deficit that they've never had in 20 years. So it was not possible no matter even if you had the miracle drug, for them to say. Yes, I will reimburse because they just don't have the money to pay for it. It's as simple as that. It's not a privately regulated system.
Georgi Yordanov
That's great. So maybe, can you can you remind us how many countries in Europe is have the reimbursement negotiation being completed, and then how many have you launched in?
Karim Mikhail
So when we started 2022, we had only one country in pricing, reimbursement negotiation, we finished 2022 with 10 submitted doses and five approved. So we have now the product price available and in launch phase in the U.K., in Sweden, and Finland and Austria and Denmark. And our price in those five markets is very similar, in the range of €5, €5.3 per day, almost $2,000. Net a year, which is completely in line with what we committed to that we believe there is significant value in terms of revenue.
Very recently, we compare this price with the average cardiometabolic in Europe, larger patient population in Europe you tend to get a very low price per day, because the patient population is huge. So far, what we have achieved is very positive. Now we are in markets where we have even larger population. But where we started allows us a bit of room to negotiate. So that's the phase we're in.
Georgi Yordanov
Great. And - I guess, what are the expectations in terms of by the end of the year in terms of launches in Europe? And can you frame maybe the number of countries you're in right now, what percentage of the market is that? And where do you get where do you expect it to be by the end of the year?
Karim Mikhail
So 2023, we believe is going to be the year where we're going to have most of our pricing reimbursement decisions completed, right? We're already in launch mode in the U.K., this is now the key focus. And in 2023, let's face it, the revenue is going to come mainly from the U.K., because it will be the only country that had 12 months of revenue, other markets as they come they will contribute to the revenue.
But as we always say, you know, the easiest thing in Europe is to say let's accelerate, the negotiation, they give us a price and we say yes. Well guess what, if this is a, I'm just making a number 20% discount. You agree to that you agree to it for the next 10 years. We have regulatory exclusivity until 2031. So imagine, by giving 20% of the price you would give 20% of the area under the curve.
That's why the wise decision is always take more time to negotiate, because that price point will always be better than just making a concession to look good that you're rushing to market it's always better to keep the price as high as possible, because they only go lower in Europe not higher.
Georgi Yordanov
That's great, very helpful. And as we think about the U.K. specifically, can you can you provide your recently provided some updates in terms of early uptake or the feedback availability? Can you can you share any additional insights and, and again, as you mentioned, like probably 2023 European revenue will be coming from the U.K. so what percentage of that total opportunities is - does the U.K. represent?
Karim Mikhail
Sure, I'll start with the sort of last part of the question. So any large market in Europe, like U.K., Spain, France contributes generally, somewhere between 10% to 15% depending on, how successful you are, so if you add them all up, that are going to be like 60%, 50%/60% of your total, and then the mid small size, they will contribute the rest. So the U.K. will probably contribute more than 50% of the revenue of this year based on what we expect.
How we're doing, we feel very confident of the launch. So far, we've recently shared, at our earnings call, some data that shows compared to bempedoic acid and inclisiran how are we doing with formulary listing. This is another thing that again, for U.S. investors and U.S. analysts is very different. In the U.S. once you agree on a contract the product is in and there is nothing else to do. There are different health systems in Europe.
And again, I hope we're not trying to paint a more complicated picture, because we don't want to scare anybody. But this is that environment. And it has advantages and disadvantages. The advantages are in the U.K., you need to be funded, which in our case, we are funded with no discount, we are one of the very few products on the market, where we demonstrated the value, and we were not required to reduce our price.
Okay, so that's number one. But then you need the formularies of the key accounts to list you. So there is a discussion to convince them of the value of your drug. So imagine we compare ourselves with bempedoic acid, we compared ourselves with inclisiran. That's the data that we shared a few days ago. And in the case of bempedoic acid, it's an LDL reduction. So the concept is quite simple, right? People would accept to list you right away.
Inclisiran was an NHS driven deal with Novartis, meaning they discounted the price so much to agree with NHS, that they're going to fund this for 300,000 patients. So theoretically, you can be listed on any formulary right away, because the government is saying I'm pushing for that. And in both benchmarks, we actually were better than bempedoic acid as good as inclisiran, if not better, and that shows that the team on the ground in the U.K. are doing a wonderful job with the early access.
Now we need to turn this into prescription the product is available, the product is going to be paid for by the key accounts. Now it's a question of convincing physicians, challenge we had, if you remember, REDUCE-IT was not implemented. We did not have sites in Europe, with the exception of the Netherlands and Ukraine. So in many of these countries, the physician does not have any hands on experience.
When we launched REDUCE-IT in the U.S., there were five years of pre-marketing before that. So it's definitely taking time to get the product up to speed, but we feel very confident of the future.
Georgi Yordanov
That's great. And if we think about the formularies, do we have an idea of like, what percentage of the formulary you're in?
Karim Mikhail
Yes, so now we have 19 out of the top 20. Okay and that covers 50% of the eligible patient population already. And we are not even, you know, three months after launch, where we have open availability to half of the market. And again, we've shown data that says, Who can prescribe within that account, because these are important details in Europe at times, especially in countries like Italy.
You have the product available, but it's restricted prescription for a number of physicians. What we got in the U.K. and all these accounts is at full open 100% prescription capability for anybody, GP cardiologist, endocrinologist, first intention, second intention, repeat or new. So that is also a great thing.
Georgi Yordanov
And it's just a matter of time to get to 100, rather than there is more?
Karim Mikhail
Yes, but we already have - we already have, honestly the big bulk of it. Now it's a question of driving awareness, building the adoption and making sure that the prescriptions.
Georgi Yordanov
That's great, so maybe that's actually a good segue to the next question, which is, how - can you talk about how prescribing for an indication like, was - is approved for how - might it differ from the U.S. in Europe, in terms of the specialties of clinicians?
Karim Mikhail
So, it depends on the country, right? There are countries that are very well known to restrict prescription to specialty. So in Italy, for example, it's a country very well known to restrict to specialists at launch. They'll keep you there for a year or two, just to make sure that actually the product is not misused. It's not like they don't want you to sell. They want to make sure that the product is going to be used appropriately.
So they say you're going to be with cardiologist for a year or two, and then we're going to open it up for GPs. In the case of the U.K., we don't have any restrictions on prescribers. In the case of Sweden, Finland and all these other markets, we do not have any restriction on. But we are reimbursed for established CVD patients not for the primary prevention patient population.
Georgi Yordanov
And your current sales force, what percentage of I guess of the total opportunity do they have access to?
Karim Mikhail
So, we currently have a small specialty team in the U.K. Because of the way we sequence the plan, we've been incredibly cost/cash conscious, as we're launching. So we did not go with the approach of let's always go with the big guns, and let's throw all the money we have, because in Europe that actually doesn't pay out. What you need to do is you build, you step on what you build then you go even higher.
So, we currently have a small team targeting cardiologist, endocrinologist and key clinicians. But we feel very confident with what we have at this point in time and at the right time, we will expand obviously.
Georgi Yordanov
That's great. And I guess, thinking about the launch, and how we could, I guess, track or set expectations, what we kind of like started the questions about? Are there any, I guess examples of European launches that could be helpful to investors, it's usually very helpful to kind of have a comp and kind of get an idea of like, what has happened before? How can we think about it now, obviously, the unique every situation is unique?
Karim Mikhail
Yes, every situation is unique, your right again, and this one is even more unique, right? Because there are so many - you could say, oh fibroids could be a good competitor. But fibroids don't have a cardiovascular claim, right? They've reduced triglyceride, but they don't have a cardiovascular risk claim. So there are a number of ways of going about this. First of all, this is a product that's going to be used on top of a statin.
So the most logical thing is for you to look at products that are used on top of a statin what is used on top of a statin today, ezetimibe is used on top a statin PCSK9, are used on top of a statin. Unfortunately, for those two there are, you know, disadvantages of looking at them as ezetimibe is 15 plus years old or more. And PCSK9 are injectable, and very expensive. So they will provide some value, but not so much.
So we also add to the mix products that have a cardiovascular risk reduction, like some of the anti-diabetics like some of the anti-platelet products. So hopefully soon for the U.K., we will be able to share some of this data just to compare and contrast. How are we doing with others? The challenge with these comparisons is that we show revenue data based on list price. And we are the only product may be on the market that does not discount.
So we're going to be disadvantaged compared to everybody else, but I still believe we're still going to look, you know, better than expected so, looking forward to share this data late this year.
Georgi Yordanov
That's great. And have you provided any guidance in terms of what our expectations should be for ex U.S. sales this year?
Karim Mikhail
So, I want to say we, we would be probably the party that is most excited about sharing guidance, right? We've been working on these numbers ourselves for the last three years, you know, what is Europe going to sell and by year and so on, we have a very, very robust model. We already said that it's going to be above a billion. Our challenge in the negotiation is imagine you are negotiating with the Spanish government.
And at the same time, you're going publicly to say, here are going to be my revenues by year over the next whatever five years, while you're actually negotiating with them, potentially a volume price deal. They're going to see these numbers. That's not how you do things, right. And remember, there is no pharmaceutical company in general, that gives guidance about Europe, right, especially when you have one product, because it puts you at a very risky position.
Now, having said that, we are very keen on communicating guidance, we want to communicate guidance, because we want to show what you know what to expect for an investors, but we really want to wait until we have the big markets negotiated. So that's, you know, Spain, Italy, France, to make sure that we have this and then at that point in time, it would be more logical to share some of this data.
Georgi Yordanov
That's great. So a lot of progress maybe. Can we talk about Germany, specifically, is there a chance we can revisit that opportunity? And then if we don't, what percentage of that market? I guess we won't have access to show?
Karim Mikhail
So back to Germany, and we just discussed a few minutes ago, what has happened in Germany, why we are where we are and we passed through a phase where nine out of 10 products in Germany got no additional benefit. And that was not because of anything related to the drug that was something related to their, own budget and what they're able to pay. So to rush today to Germany is useless, because the situation the economic situation has not changed in Germany dramatically.
So to go and try to renegotiate now doesn't make sense. So step number one is get the other markets approved, show Germany, that they are singled out, by the way, historically, they've been singled out many times. And they don't get sort of ashamed of that so, but make sure that there is Pan European endorsement of your price level, that's number one. Number two, start working on your resubmission.
Because you need to come back with different data, you need to come back with a different approach, which we're working on. But very recently, you have read maybe in the news that there, have been a very historical litigation in Germany, you know, a company that actually challenged the German system and said, no, no, you miss actually judged me. And this is the first time in German history and they won the case.
And that case has similarities with our product, not 100%. There are similarities, the similarities are this was a product that did not have a clinical competitor. In our case, we also did not have a clinical competitor. So, we definitely are going to explore, you know, avenues of using that it is still too early to judge whether this is going to be a viable solution or not. But this is a team that does not give up, right? So we're going to keep trying to go back to Germany, because it represents 10% to 15%, of potentially European revenue.
Georgi Yordanov
That's great. And thinking about outside of the EU, can you help us define that opportunity? We saw recently, the deal we signed, which provided some small non-diluted funding, or can we can we expect some tax similar in the future?
Karim Mikhail
Yes, so - remember, this is an initiative that started in August 2021, right. So in August 2021, where we basically said, we are available in Europe, we are available in the U.S., but there are so many other important markets beyond U.S. and Europe. And we initiated the process to get regulatory approval in 20 additional countries beyond U.S. and Europe.
Some of the early approvals that we got was in Australia, and by the way, Australia participated in the REDUCE-IT study. So it is a country that has hands on experience with a number of sites that was implemented there, where we have regulatory approval today, and you've seen us, communicating that we have a partnership there. So this is a very active program.
We have the deal with CSL Seqirus that we're very, happy with, they're the ones who introduced, you know, the Moderna vaccine to Australia, so a very robust, reimbursement/commercial team. And - we also made comments that we are working on potential partnership in Southeast Asia and Eastern Europe that we - are ready to execute in the near future. And the size of the opportunity to your question is significant.
And I remember that you had some of your own sort of analysis, showing that for a product like Lipitor, the split between us and ex, U.S. revenue was 50:50. And when you look at that splits, you'll see that the 50, that's ex U.S. and imagine, the potential for the U.S. business for the VASCEPA was somewhere between the three to five, right? Imagine if you can recreate that ex U.S.? Well, two thirds of that are going to come from Europe, and one-third is going to come from rest of the world.
And I believe these data on Lipitor, did not include China as part of them. But definitely the opportunity, the magnitude of the opportunity ex U.S. is significant and can be in the cardiometabolic space as big as the opportunity in the U.S. It just takes time to build it and to develop it over time.
Georgi Yordanov
Now that's a very good point. And I believe the specifically for Lipitor, didn't have to take some pretty significant discounts on their pricing in Europe?
Karim Mikhail
Yes.
Georgi Yordanov
So opportunities even larger, you've talked in the past about franchise extension strategies for VASCEPA and specifically combinations with statins. Can you provide - an update on that?
Karim Mikhail
Sure. So first of all, we feel very strongly about the value of fixed dose combination within the cardiometabolic space. If you were at European Society of Cardiology, the last conference, there was a whole session about treatment strategies. And it was all about fixed dose combination. It was about how can, you use multiple products to just help the patients. For us we're introducing a new paradigm of treatment in Europe.
If you can somehow associate yourself with a non-molecule that's used loved, on daily basis, that just gets you to gain years of adoption, right, instead of just going it alone. You put yourself with a strong statin then very quickly you become a far more familiar product. Now on top of that, you get potentially, a better lifecycle management strategy, because it allows you to continue to penetrate allows you to negotiate price at the right time.
Meaning that your price revision time-point three, five years, you go to the European government, and you say, look I have a deal. I'm going to give you the statin for free, if you don't actually impact my price, and you keep going. So instead of get a price erosion, you keep that price increment, imagine if this was only 5%. And imagine if that 5%, you are going to get three times until you lose exclusivity.
Three, multiply by five compounded it's like 17%, 18%. That's a lot of area under the curve, to create. So we feel very strongly that this is an opportunity, you saw that we communicated that we submitted to EMEA. For advice, we got back feedback, we're working on our response on this, and we're going to continue to pursue it. This is a challenging initiative. Let's be very clear, it's not that easy to put and oil with a solid in one product, right.
So there are formulation challenges, there are potentially stability challenges. So, we don't want anybody to think oh, this is going to happen anyway. No, no, this is a challenging initiative, but it's worth pursuing. It is worth pursuing. And all the larger franchises have fixed those combinations ezetimibe had four Cozaar had two, JANUMET had one. So many, many of the franchises have that.
Georgi Yordanov
Okay, why don't we wrap it up there Karim. Thank you, for taking the time, all the best to you and your team as you continue to execute the launch and enjoy the rest of the conference. Thanks.
Karim Mikhail
Thank you.
The problem is "retract current ANDA" won't shut down generics.
J, the $6.4B question is would that be too much trouble and not enough profit potential even for a BP. From the benefit of the society standpoint, it makes sense. However, from a business standpoint, does downgrading the #1 killer (CVD) in the world to #3 killer in the world make business sense in the long run, especially since the generics would reap the benefits in less than 8 years?
duke, generics won't file any new ANDA because they already got what they want.
Bristol Myers axes German launch of new cancer drug, citing pricing hurdles:
Following its European approval last September, Bristol Myers Squibb has decided not to launch Opdualag, an infusion of the pharma giant’s Opdivo and new antibody relatlimab, in Germany due to pricing pressures. The drug won approval to treat advanced melanoma in adults and adolescents aged 12 years and older.
Per a Bristol Myers spokesperson, Opdualag won’t be marketed in Germany “for the foreseeable future,” as the country’s drug pricing law from 2010 makes it so that the pharma giant “sees no possibility to achieve a benefit rating from the G-BA [Gemeinsamer Bundesausschuss] for Opdualag.”
Not including that benefit rating from the G-BA means the price regulator does not think Opdualag has any additional benefit over its appropriate comparator (“preferably a therapy for which endpoint studies are available and which has proved beneficial in practical use,” the German regulator’s English website says), so the drug’s yearly treatment costs cannot be higher than what it is being compared to.
Part of the reason is due to BMS’ use of progression-free survival (PFS) in measuring Opdualag’s efficacy. A BMS spokesperson said that while the combo drug demonstrated statistically-significant PFS over anti-PD-1 monotherapy in patients with advanced melanoma, the AMNOG law does not consider PFS a “patient-relevant endpoint.”
Bristol Myers added:
Our goal is to make Opdualag available to appropriate adult and adolescent advanced melanoma patients in countries around the world where it is approved for use. We are disappointed that this is not possible in Germany at this time due to the current benefit assessment system and recent GKV-FinStG reforms. We remain open to reconsidering should that change in the future.
According to the Munich-based lawyer Gabor Kiss, last November, the new GKV Financial Stabilization Act (GKV-FinStG) law came into effect, and one of its provisions also set an additional 20% rebate for drugs that are used as a combination regimen and that fulfill certain criteria. BMS’ Opdualag could have potentially fulfilled those criteria if the company had gone through the process.
BMS Germany’s general manager Neil Archer said in an email, “Pharmaceutical innovation needs long-term planning horizons. And long-term planning horizons need stable framework conditions.” Archer added that Germany is a location where “pharmaceutical innovation and investment is recognized has deteriorated significantly.”
https://endpts.com/bristol-myers-axes-german-launch-of-new-cancer-drug-citing-pricing-hurdles/
M, can you criticize someone if you cannot offer a solution? I am glad that you are not the person in charge of Amarin.
Don't count out Merck,
Merck's cardiovascular future takes shape as sotatercept overachieves, PCSK9 inhibitor passes phase 2:
https://www.fiercebiotech.com/biotech/mercks-cardiovascular-future-takes-shape-sotatercept-overachieves-and-oral-pcsk9-passes
I believe NVS takeover of AMRN would produce the most synergy. I believe its twice-yearly PCSK9 would package well with V. Below is an old rumor:
https://www.streetinsider.com/Hot+M+and+A/Novartis+%28NVS%29+Rumored+to+Be+in+Talks+to+Acquire+Amarin+%28AMRN%29+-+Source/15168230.html
AMRN is at a very attractive risk/reward situation currently. The downside is $1.85 while the upside is multiple of that. Assuming a 50/50 BO probability in the next couple of years, it's a strong buy even for the risk-averse.
j, forget about further indications as there is no large FDA-approved trial going on investigating V. MITIGATE and BRAVE do not count as they are too small.
The ONLY way out is for Denner to find a BP which would find Vascepa to be synergistic with its existing cardiovascular portfolio.
Capt, thanks for the nice visual. So it's a bad week as GLV>GV>V. Please include these comparison graphics in your weekly service, if not too much trouble. TIA.