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zip, I don't know if you remember at least one of the panel members adamantly objecting to CV death reduction being allowed on Vascepa's label, which I think really hurt Vascepa's widespread adoption.
DewD, is there any precedent of clinical trials proceeding directly to phase-3 without running a phase-2b, especially in the GLP-1 field? TIA.
In the spirit of maximizing shareholder value, does anybody have recommendations on how to vote on the nine proxy questions? TIA.
Mufaso, you might have seen this:
https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15184
DD, the following might explain PFE's stock price movement today:
Re Morgan Stanley $MS today
— Marc Lehman (@markflowchatter) March 6, 2024
Im told $MS is down on 'not" getting added to the Dividend ETF $SCHD after all, ripped the other day on this and $MO and $PFE fell off on it..
hence the up moves in $PFE and $MO today
The rebalance was WRONG
@Pharmdca has a nice post few days ago:
$VKTX $NVO $LLY $GPCR Oral comparison for Obesity drugs
Efficacy
$LLY has 3% placebo adjusted weight loss at 4 weeks
$GPCR 4.7% by 4 weeks, no change at 8 weeks, next update Q2
$NVO 9.5% by 26 weeks
$VKTX 4 cohorts like SubQ, max dose 20mg once daily
Could they have added a higher dose over 20mg and could that be the reason for data delay, we will find out soon.
Keeping in mind 50-60% exposure for the oral drug vs SubQ, placebo adjusted weight loss could be 3% or higher
How $VKTX dual agonist profile comes into play vs just GLP-1R for all oral agents will be seen.
Management hasn't shared much information at all.
I think the main goal for this trial is to look at oral drugs' exposure, safety, PK profile to guide them for the design for PH2 trial.
$VKTX $NVO $LLY $GPCR Oral comparison for Obesity drugs
— Pharmdca (@Pharmdca) March 3, 2024
Efficacy$LLY has 3% placebo adjusted weight loss at 4 weeks$GPCR 4.7% by 4 weeks, no change at 8 weeks, next update Q2$NVO 9.5% by 26 weeks$VKTX 4 cohorts like SubQ, max dose 20mg once daily
Could they have added a…
Mufaso, great point about "more Semaglutide is delivered orally for Rybelsus than SubQ". Following is the trial design for Lily's oral:
https://dom-pubs.onlinelibrary.wiley.com/doi/epdf/10.1111/dom.15150, you can see some good separation in the 4-week curve.
I believe all 4-week oral GLP-1 phase 1 trials (LLY, PFE, GPCR, etc.) show efficacy greater than 3%, which bodes well for VK 2735 oral. Hopefully, with the introduction of GIP, VK2735 will do better in SAEs compared with other GLP-1-only oral trials.
Mufaso, you are correct. So for the 20mg cohort would be :
2.5mg/day the first week
5 mg/day the second week
10 mg/day the third week
20 mg/day the fourth week
Still, much more VK 2735 given to the body compared with VK2735 phase 1 SQ trial.
Mufaso, as you know, the VK2735 oral phase 1 has 5 cohorts: placebo, 2.5, 5, 10, and 20mg/day. For the 20mg/day cohort, that's 140mg/week in oral compared with 15mg/week SQ in VENTURE for the highest dose. That's 9 times more VK2735 in a patient's body in a week. Given the long half-life of 2735, would be interesting to find out VK2735 oral pill's effect on efficacy and tolerability. Do you think Brian Lian's 50-60% estimated degradation in absorption from SQ to the oral pill is a comparison between one VK 2735 oral pill Vs one VK 2735 SQ injection of the same dosage?
Patrick Holt
Thank you, Mark. Good morning, everyone, and thank you for joining us today.
Before we review our 2023 highlights and our 2024 priorities, I want to take a moment to reflect on our strategy at Amarin. Every day, our team is focused on driving operational momentum to maximize the patient uptake of VASCEPA/VAZKEPA.
To enhance the value of Amarin and deliver shareholder value, we must drive operational momentum across our three key regions. In Europe, where we have a potential IP runway out to 2039, we are focusing efforts and investment to accelerate prescription growth and revenue as well as secure pricing and reimbursement in those key markets.
In the US, we're maintaining and extending our IP market leadership. And in the Rest of World, we're enabling our partners to get our product into the hands of as many patients as possible. We firmly believe this focus on operational momentum is the best path forward for Amarin and will more strongly position us or potential future options.
Turning to Slide 6. While we believe this strategy is the best way to deliver shareholder value today, the only way to gain shareholder confidence is to deliver against it. We have made meaningful progress in 2023, and we have clear priorities in place for 2024.
For Europe, in 2023, with new leadership and a more focused strategy in place, our teams made launch progress and have advanced pricing and reimbursement goals. In Spain, our team is focusing on health care practitioners who are early adopters of cardiovascular products.
We are continuing to deliver strong launch progress such that we now have approximately 2,500 patients on therapy. In the United Kingdom, we have a more focused strategy in place, including driving uptake in key accounts. Currently, we have at least 1,500 patients on therapy.
Turning to pricing and reimbursement. We've secured pricing reimbursement across nine countries in Europe. As I have shared previously, we have strengthened our focus to advance our opportunities in key EU five markets.
I'm pleased to share in Italy, we have now resubmitted our dossier and will advance this process with the authorities to potentially achieve market access for VASCEPA by the end of 2024.
In France and Germany, we are sharpening our scientific arguments and have strategies and plans in place to advance submissions for VASCEPA in these markets. We do not expect these processes to conclude in 2024. We will continue to communicate progress on France and Germany as additional steps are achieved.
Importantly, we are also aiming to successfully conclude pricing reimbursement decision in at least five additional markets in 2024. We remain confident in our path forward in Europe. We have patents and applications that have the potential to extend our IP up to 2039. As a testament of this progress, we successfully defended our 2033 patent from opposition. We expect to share more on this topic in the coming months.
Turning to the United States. In 2023, we continue to extend IP market leadership, closing the year with a 57% market share. We achieved this through focused investment in managed care, trade and medical capabilities to extend VASCEPA's life cycle despite the elimination of our sales force and reduced marketing spend in July.
As we turn to 2024, we have begun the year in a slightly improved position compared to last year. Based on what we currently know with our exclusive accounts, these represent at least 50% of the total IP market volume. While we are encouraged to start the year in a solid managed care position, the market remains highly dynamic, and we continue to monitor this closely.
We do expect Q1 2024 results to be impacted by typical first quarter payor dynamics. We continue to stand ready to execute aggressive approaches, including the potential future launch of an authorized generic bolstered by our strong supply position to retain market leadership within the IP market.
In the Rest of World, in 2023, we made progress on regulatory market access and commercial fronts as well as new partnerships. In China, the second largest cardiovascular market globally, Amarin's partner, Edding, launched VASCEPA in October for the very high triglycerides indication.
Additionally, that NMPA has accepted the regulatory filing for the cardiovascular risk reduction indication, which opens up the potential for future national reimbursement and drug listing.
In 2023, Amarin also entered into three new partnerships across 15 countries. In 2024, our focus for Rest of World shifts toward enabling our partners to obtain market access and commercial uptake across key markets.
Finally, in Research and Development and Medical, our teams delivered important progress with data publications and medical education, supporting our brand globally to build confidence in our science.
In 2024, we will continue to build on this momentum, including additional data on REDUCE-IT and EPA. Indeed, we have seven abstracts at the upcoming American College of Cardiology meeting in April. We'll be showing more on this in coming weeks.
This important operational progress has supported our financial position, with $321 million in cash and no debt. As you're aware, due to our recent progress in our financial position, we announced plans for a share repurchase program of up to $50 million.
I'm pleased to share that we are on track to complete the necessary shareholder and UK High Court approvals. We continue to anticipate completing these steps in the second quarter of 2024, and that share repurchases would commence shortly thereafter.
In summary, 2023 was a meaningful year for operational momentum, and we are well positioned to continue to build on this in 2024.
Now, I'd like to hand over the call to Tom Reilly to review our fourth quarter and year-end 2023 financial performance. Tom?
Tom Reilly
Thank you, Pat. Good morning, everyone. I'm pleased to report details on our financial performance for the fourth quarter of 2023.
In the fourth quarter of 2023, Amarin reported total net revenue of $74.7 million, including net product revenue of $70.6 million versus $66.1 million in the third quarter of 2023 and $4.2 million in licensing and royalty revenue.
US product revenue was $64.9 million, with stable performance in the US despite multiple competing generics on the market. The US business continues to provide profit supporting our expansion into Europe.
The revenue results include European product revenue of $1.5 million, a 65% increase versus the third quarter of 2023, reflecting early revenues from European markets, including Spain and the United Kingdom.
We recognized $8.4 million in the Rest of World revenue in the fourth quarter of 2023, including product revenue of $4.2 million related to commercial sales to our partners in Canada, China and the Middle East, and licensing and royalty revenue of $4.2 million, resulting primarily from the achievement of the Edding CVRR milestones.
Cost of goods sold in the fourth quarter of 2023 were $29.6 million compared to $23.6 million, excluding restructuring in the third quarter in 2023. Amarin's overall gross margin on net product revenue in the fourth quarter was 58% compared with 64% in the third quarter of 2023. This was primarily due to an increase in one supply sales to our partner, Edding.
Moving on to operating expenses. Operating expenses were $49.7 million in the fourth quarter, comprised of $43.9 million in selling and general and administrative expenses, and $5.8 million in research and development expenses.
In the second half of 2023, Amarin reported operating expenses of $101.2 million. This represents a $21 million reduction in operating expenses versus the first half of 2023. We are on track to deliver the previously announced $40 million reduction in operating expenses by July 2024. Amarin reported a net loss of $5.8 million for the fourth quarter of 2023 or basic and diluted loss per share of $0.01.
Let me now turn to our efforts and results in controlling costs and effectively managing our cash. As of December 31st, 2023, Amarin reported aggregate cash and investments of $321 million. Importantly, this is the sixth consecutive quarter of positive or neutral cash flow generation for Amarin, and our cash balance is now $10 million higher when compared to December 31st, 2022.
In 2023, we made progress in controlling our costs and managing our cash position through our cost reduction programs and renegotiating supply agreements. In 2024, we will continue to focus on cash preservation, prudently invest in right opportunities, particularly in Europe, based on pricing reimbursement decisions and pending shareholder and UK High Court approvals will initiate our shareholder repurchase program.
With that, I will now turn the call back over to Pat for closing remarks and to begin the Q&A portion of our call. Pat?
Patrick Holt
Thank you, Tom, for the financial overview of our results. Our team is focused on operational momentum to maximize shareholder value across all three areas of our business. We believe we have the right plan, focus on operational momentum to drive shareholder value. We have a strong future because of our fundamentals, best-in-class science supporting VASCEPA/VAZKEPA, a large global opportunity to impact cardiovascular patients, a team that is dedicated to delivering results, and a strong balance sheet.
Finally, thank you to our colleagues for their commitment and dedication. I look forward to driving shareholder value together.
And with that, Mark, let's begin the Q&A portion of the call.
Mark Marmur
Thank you, Pat. As we announced last year, to enhance engagement with the company's shareholder base and facilitate connections with its investors, Amarin is partnering with Say Technologies to allow retail and institutional shareholders submit and upvote questions, a selection of which will be answered by Amarin Management during today's earnings call.
Let's begin the Q&A. So Pat, we received a number of questions on the company's long-term strategy and ways that we plan to maximize shareholder value. What would you say to these investors?
Patrick Holt
Thanks for the question. I get this question a lot. It's a really an important question. And we believe, the best path forward for us to both increase our value and put us in the best possible place for future strategic options is today to focus on our current efforts around operational momentum, whether that be in Europe, in the US or in the Rest of World. As we shared earlier in the call, we really are making progress on all three fronts, which provides us greater optimism and optionality for the future.
Mark Marmur
Great. Thanks, Pat. Our second set of questions focuses on China and Asia Pacific. What can you tell us on progress around the commercial launch in China? And what is the status of the cardiovascular risk reduction regulatory following China? Also, more broadly in Asia Pacific, can you share any updates on efforts with our partners?
Patrick Holt
Well, there's a lot in that. And as for the, some of you know, I know this region pretty well. So let me break that down in some parts. Firstly, to the China launch. So Amarin's partner, Edding, is really making important progress in China, which I'll remind everybody, is the second-largest cardiovascular market globally. Edding have launched VASCEPA for very high triglycerides in Q4 2023. To give you a flavor, the Edding sales force is covering 200 hospitals, which includes around 500 key opinion leaders, the majority of which are cardiologists in the three largest cities of Beijing, Shanghai and Guangzhou. So in summary, the launch is progressing well, and the structure of the agreement provides immediate profitability to Amarin. So let's move from today and also think about the future in China as we reflect upon the cardiovascular risk reduction indication. The NMPA has accepted the regulatory filing for cardiovascular risk reduction, which opens up the potential for national reimbursement drug listing. The submission was accepted with a clinical trial waiver, meaning a separate clinical trial will not be required in order to be reviewed for approval. The teams are now focused on advancing that submission together with the authorities and we expect the regulatory review process to conclude in 2025. Asia Pacific is a large region, so let me just touch on some other areas within the region. As you know, last year, we entered into partnerships in Australia and New Zealand, with CSL Seqirus, and also 11 Asian markets, including South Korea with Lotus Pharmaceuticals. I'm pleased to share that CSL is advancing pricing and reimbursement processes in Australia with the authorities. And in other markets, our partner, Lotus, is advancing regulatory discussions and filings with the various authorities across the region.
Mark Marmur
Great. Thanks, Pat, for that information on China and Asia Pacific. Now turning to the US. Is there a path toward growth in the market? Could we potentially take market share from other products or classes?
Patrick Holt
Great question. And naturally, our US revenues and cash flows are incredibly important to our business. When we take a step back and we think about the US market and where it stands today, it's important to remember that the IP market in the US is highly genericized at this point. Our focus has been and continues to be to maintain IP market leadership. And as a result of that, not focused on growing the market. We really have achieved a highly atypical performance three years post LOA to end 2023 with a market-leading share of 57%. We've been able to secure market leadership and continue that success through our exclusive contracts, led by our capabilities in payor, managed care and medical areas. Again, as we mentioned, we've started 2024 in a strong position in terms of our exclusive contracts. But to remind everybody, it's a dynamic market, and we do watch it very closely and continue to assess our optionality for our branded product and beyond that should we consider other strategic alternatives. In terms of taking share from other products or classes, given those generic dynamics, we do not view this as an optimal strategy.
Mark Marmur
Thank you. Turning to supply. If we see demand increase from Europe or Rest of World partners, are you confident that we can meet those supply demands?
Patrick Holt
It's a very important question. And we do have strong relationships with our key supply partners. Over the last several years, we've made really important progress, renegotiating our supply agreements to ensure that we can both meet our demands as well as reduce key supply commitments. We feel really confident that we can meet those supply demands moving forward.
Mark Marmur
Now, one last question on the R&D side from the Say Technologies questions. Is Amarin working on advancing any additional indications for VASCEPA/VAZKEPA?
Patrick Holt
I was really pleased this question came up. And it's such an important question when you think about the core strength that Amarin has in terms of our R&D team and our IP capabilities and leadership. This is the team that has developed and advance the molecule from day one, and deliver the REDUCE-IT data that really has a global impact that we see today. With our team in place, we do continue to look at opportunities for new indications and we will update investors based on potential future progress of that work. So before we take additional questions, I'd like to thank those shareholders who submitted questions via the Say Technologies platform. We are committed to continuing open and transparent dialogue with all of our shareholders, and the Say Technologies platform is one way that we are trying to increase engagement and two-way dialogue with you. We look forward to continuing to hear from you and answering your questions on this platform as well as other opportunities moving forward.
Mark Marmur
Thank you for those updates, Pat. We'll now open the Q&A up for additional questions.
Question-and-Answer Session
Operator
Certainly. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Your first question for today is from Roanna Ruiz with Leerink Partners.
Roanna Ruiz
Hi. Good morning, everyone. So could you talk a bit more about the ongoing generic competition in the US? Like what trends are you seeing in the field? And what do you expect in terms of possible pressure on VASCEPA net price in the next couple of years?
Patrick Holt
Hi, Roanna. Good morning. Thanks so much for the question. Great to hear from you. As you probably have followed, there are more generics that have got regulatory approval, there are more generics that have also got prices. And with that said, what we see in terms of the market dynamics in the market so far, they remained fairly stable. So as we mentioned, we closed the year and we started the year with a strong position with our exclusive contracts that represents greater than 50% of the IP volume. So as we end the year and start the year, we are feeling really good about that position. But as I'm sure you've noted, there is more dynamics and there are more entrants in the market. So we continue to monitor it very closely. But I would say so far, and we haven't seen any dynamic changes from what we have seen historically. But obviously, we track it closely. And as you know, we have optionality in the short term as well as the long term to maximize the economics for us in the US.
Roanna Ruiz
Yes, makes sense. And a quick follow-up on the Rest of World. I noticed it's gaining some traction. So could you talk about what regions you expect might contribute the most momentum to future growth in revenues in 2024 and beyond?
Patrick Holt
Yes. It's a great question. As I mentioned, we're really -- it's pleasing to see the progress in 2023. As you think, we always -- we signed up some new countries in 2023. If you take a step back in 2023, the main revenue sources, until China came on board, was really coming from Canada and then parts of Middle East, North Africa. So what we'll see in 2024 is certainly continued value coming from those existing partnerships such as what I've just mentioned. So I do expect that China will have more progress in 2024. And then there is the opportunity, I think as some of these partnerships start to go from signing through regulatory process such as Lotus, market access, reimbursement and pricing, such as CSL Seqirus in Australia, New Zealand, you're starting to see a shift from entering partnerships to really more driving through those pre-commercial and commercial outputs. So we're pleased that we're progressing through that life cycle of partnership and lines management, I would say, and we see that shift in the business towards more revenue, market access and revenue generation. And internally that means we're beefing up our capabilities and leadership to support that group.
Roanna Ruiz
Got it. Thanks.
Patrick Holt
And that's -- to add that. It's really -- it is a key part of our goals and our strategy, that Rest of World business, and it provides immediate profitability for us.
Operator
Your next question for today is from Jessica Fye with JPMorgan.
Unidentified Analyst
Hi, guys. Good morning. This is Na Sun on for Jessica Fye. I have a question on your progress in launching VASCEPA there. Can you just talk a little bit about how to accelerate the growth in UK. And then for Germany, have you come up with a plan to reenter the market there? And then for Italy as well? Thank you.
Patrick Holt
Thanks, Na Sun. Great to hear from you. Look, Europe is obviously critical for us. It's a key focus of our investments and a key focus of the whole organization as we move forward. So as we break that down, we think about those key launch markets. And as we've previously mentioned, the UK is quite an individual market, and the uptake in the UK is typically solar. We are making progress with a more focused strategy on those key accounts. And as I signaled earlier, we now believe, we estimate we have at least 1,500 patients on therapy. Building on that, we did say from that moment of launch last September that we did expect Spain to be a faster uptake market, and that is proving true. So we're pleased with the progress and the uptake we're seeing in Spain on a national basis. And today, we see -- we estimate we have around 22,600 patients on therapy, which is important progress for us. So they're two key launch markets for us. As we move into some of the reimbursement markets, we've resubmited in Italy, building on our previous strong scientific assessment and we do expect Italy pricing reimbursement to conclude in 2024. And then if we think about Germany, to your next question, you know our history in Germany. So that's a topic where we've taken a step back and we are redeveloping a potential new strategy to enter the market. We're working with the authority to assess different ways to consider patient populations that can be relevant for the German market, and we're working with the authorities on those plans, and we continue to advance that through 2024. But as I mentioned, I don't expect that those processes will conclude in 2024. Thanks very much for the question.
Operator
Your next question for today is from Louise Chen with Cantor Fitzgerald.
Unidentified Analyst
Hi, team. This is Wayne on for Louise and thanks for taking our questions. So first, you have reiterated that you're on track to deliver the $40 million annual savings. And so how should we think about the operating expense for 2024 because compared to the second quarter, you save about $7 million in the third quarter and $8 million this quarter? So should we expect a similar number going forward? And then the gross margin has dropped to 58%. So how should we think about this going forward? Thank you.
Tom Reilly
Yes. Great. This is Tom. Thanks for the question. Related to the operating expense and the $40 million, which we're on track to deliver and our expectations for expenses. As mentioned before, we reduced expenses from the second half to the first half of '23 by $21 million. Our cost basis is approximately $50 million per quarter. Our expectation is to stay within that range, depending on pricing reimbursement decisions. We will invest in those opportunities, but we'll find other ways to reduce costs. So our overall expectation is to stay within that $50 million operating expense basis. Related to your question on gross margin, very good question. Thanks for picking it up. What you've seen versus Q3 is a deterioration of gross margin, but that's primarily due to launch supply that we provided for our partners, in particular in China. So as the China market is moving forward, we're providing products for revenue there. It's about a 2.5 to 3-point reduction in margin impact this quarter versus the previous quarter. And then the question on how do you expect for margins moving forward. I think it all depends on the uptake in China and how much product side we'll be providing. But we'll give updates on the progress of the China market.
Unidentified Analyst
Thank you very much.
Operator
Your next question is from Paul Choi with Goldman Sachs.
Unidentified Analyst
Hi, everyone. Good morning. This is Khalil calling in for Paul. Thank you so much for taking our question. I guess my question is about the exclusive contracts that you've mentioned in the past. As those are renegotiated, have you seen any additional pushback as more generics enter the market? And have you or will you set a threshold for those sort of deterioration on those at which point the company would pivot to your own generic? Thank you.
Patrick Holt
Khalil, thanks very much for the question. Look, obviously, we track those contracts very carefully. We do see, I would say, on an annual basis, to renegotiate our exclusive contract, we do see annual impact to those pricings in the sort of low double-digit range typically. And that's been something that we are seeing consistently. We don't see necessarily significant changes to that, but that's the sort of range that we see. What's really pleasing is we have had a strong end to the year and a strong start to the year in terms of how we're landing our negotiations. So the net-net of that means that we are participating in greater than 50% of the IP market volume. That has enabled us with our great managed care and trade and medical capabilities to pull through as we close 2023, a 57% market share in retained market leadership. To your second part of your question, of course, we track the economics and the overall profitability incredibly closely. We have specific scenarios in our mind as to when we think those are attractive and when they start to become more marginal, and we have plans in place to react based on how those dynamics change, should they change. But as it stands right now, our focus is to extend our branded life cycle as long as we can. Our organization, our US team, from my perspective, has delivered a highly atypical performance for over three years since LOA, which provides incredibly important profits for the business, particularly for our growth in Europe. So we couldn't be happier in terms of how we finished the year and how we started the year. But as you well know, it's highly dynamic. We monitor it very closely.
Unidentified Analyst
Got it. Thank you so much.
Operator
We have reached the end of the question-and-answer session. And I will now turn the call over to Patrick for closing remarks.
Patrick Holt
Well, thank you all for your attention, and thanks for all the Q&A. We really appreciate the interest and we look forward to having additional conversations on these important results in the coming days ahead. So thank you again for your time and wish you a great day ahead. Thank you.
A 5M secondary offer at $90 or above for VKTX after market close would be sweet.
VKTX, if placing a secondary after close today, e.g., 8M @$80, might actually help itself to fetch a higher BO price, if any.
Congrats Mufaso! Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity
https://ir.vikingtherapeutics.com/2024-02-27-Viking-Therapeutics-Announces-Positive-Top-Line-Results-from-Phase-2-VENTURE-Trial-of-Dual-GLP-1-GIP-Receptor-Agonist-VK2735-in-Patients-with-Obesity
Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity
https://ir.vikingtherapeutics.com/2024-02-27-Viking-Therapeutics-Announces-Positive-Top-Line-Results-from-Phase-2-VENTURE-Trial-of-Dual-GLP-1-GIP-Receptor-Agonist-VK2735-in-Patients-with-Obesity
congrats, approved!
Mufaso, thanks for the Brian Lian article. I hope we'll get the VENTURE results (early March?) before the oral phase 1 data. GLTY!
Mufaso, thanks for your continuing update on VKTX. I was listening to the VKTX quarterly call last week. There is one particular sentence, in fact, one word, that draws my attention:
"All of us at Viking are optimistic about the year ahead"
https://seekingalpha.com/article/4668442-viking-therapeutics-inc-vktx-q4-2024-earnings-call-transcript
I have searched for the word "optimistic" in the last 8 prior CC transcripts and the word "optimistic" wasn't used.
Perhaps I am thinking too much, but I hope that's a friendly hint from our CEO.
zip, big congrats to you! What test should one order to detect "Carotid artery occlusions"? TIA.
Reminded me of JT.
Without Denner's press release this morning, AMRN would have closed near $1 today. Thank you, Dr. Denner, for averting potential delisting.
Amarin Chairman & CEO Issue Letter to Shareholders
DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 22, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the Company’s Chairman of the Board, Odysseas Kostas, M.D., and President & CEO, Patrick Holt, issued the following letter to Amarin shareholders:
Dear Fellow Amarin Shareholders,
2023 was an important year for Amarin, marked by necessary transition and change. With a new board focused on shareholders, we undertook significant actions to strengthen the Company. We restructured the management team, redesigned our operations and approach in Europe, improved our financial discipline, streamlined the U.S. business to maximize cash flows and progressed our Rest of World (RoW) rollout.
We believe the company is fundamentally in a much stronger position today. As shareholders ourselves, we remain disappointed in Amarin’s stock performance. However, we believe that Amarin is significantly undervalued and that VASCEPA®/VAZKEPA® can bring tremendous value to patients globally and its true potential has yet to be realized.
With our increasing confidence in the business, the undervalued stock price and our commitment to creating shareholder value, earlier this month we announced a share repurchase plan of up to $50 million. The repurchase plan follows recent significant stock purchases by both Sarissa and our CEO, and further strengthens the alignment of incentives with our fellow shareholders.
Along with you, we believe Amarin has significant unrealized value not yet reflected in the current stock price. We know from experience that turnarounds take time, but we believe we are on the right path. We are not resting and remain deeply committed and firmly focused on creating shareholder value.
Highlights from 2023:
Strengthening leadership. Amarin’s Board identified and named a new President and CEO in Pat Holt, who provides global leadership and turnaround operating experience. We also appointed a new Chief Legal and Compliance Officer who brings deep intellectual property, complex litigation and business development experience. And we appointed new commercial leadership in Europe to implement a new strategy and drive revenues.
Improving operations. We streamlined the U.S. business to maximize cash generation. We also reorganized our strategy in Europe, including pricing and reimbursement efforts, designed to drive favorable results in key markets.
Enhancing financial discipline. The Company reduced operating expenses $100 million in 2023, and the Company is on-track to deliver an additional $40 million reduction in operating expenses. As a result, we closed 2023 with $321 million in cash and no debt.
Looking ahead, we believe we have established a strong foundation to drive shareholder value in 2024 and beyond:
In the U.S., we will focus on extending IPE market leadership, where we have maintained a 57% market share, including plans to launch an authorized generic if required.
In Europe, we will focus on accelerating revenues in key markets like Spain and the U.K., and plans are in place for pricing and reimbursement submissions in Italy, France and Germany.
In the RoW, we are focused on shifting from partnerships to implementing plans to support our partners advance market access and commercialization for VASCEPA®/VAZKEPA®.
We thank all our fellow shareholders for your patience and continued support.
Sincerely,
Odysseas Kostas, M.D.
Chairman, Amarin Board of Directors
Patrick Holt
President & CEO, Amarin
Should it be VK2735 on line 2 of your table?
AMRN only dropped 9% yesterday.
"No shorting allowed today", why?
"According to studies using electronic medical records, approximately 25% to 50% of patients discontinue statin use within six months to one year after initiating their use."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5012887/#:~:text=According%20to%20studies%20using%20electronic,year%20after%20initiating%20their%20use.
My math says, "8 more days".
Jess Fye
Great. Good afternoon, everyone. Welcome. My name is Jess Fye. I'm a Senior Biotech Analyst at JPMorgan, and we're continuing the 42nd Annual Healthcare Conference today with Amarin. I'm joined up here by the company's President and CEO, Pat Holt. He's going to give a presentation on the business and then we're going to go into Q&A. If you're sitting in the room and you want to ask a question, someone will bring you a mic, just raise your hand, or you can send questions to me on the portal and I'll read them off the iPad up here. So with that, let me pass it over to Pat.
Pat Holt
Thanks, Jess. Good afternoon, everyone. It's wonderful to be with you today. I'm Pat Holt, the President and CEO of Amarin. And Jess, thanks so much for the invitation to join the 42nd Annual JPMorgan Conference. We're delighted to be here.
So 2023 was a really important transitional year for our company. Earlier today, you may have noticed we announced our Q4 preliminary results for 2023, which are really encouraging and demonstrate important progress for our business. As an example, in Europe, based on new leadership and a new strategy, we have shared that our results for Q4 are 65% growth on Q3, really demonstrating some solid progress, particularly in Spain and the UK.
Our US business continues to demonstrate excellent -- extending our life cycle. So in the US we also announced that we have continued 57% market leadership. That market leadership has been sustained for three years post-generics here in the US. And indeed that 57% has been stable for 12 months.
Lastly, we are very encouraged by our rest of world progress, particularly China, where we've launched the very high triglyceride indication and we have had -- the China FDA accepted our filing for cardiovascular risk reduction. As a result of that, financially, we've made important, necessary and difficult steps to unlock $100 million of value in OpEx improvement in the business. The improvements we announced in July of an additional $40 million are on track. And so therefore we close the year in a strong cash position of $321 million of cash, no debt, which demonstrates six quarters of cash flow neutral or cash flow positive performance and indeed a $10 million advance in our cash flow versus prior year.
So these are really pleasing and encouraging results, and therefore give us real confidence. And we believe that that momentum we can take into 2024. Whether we think about how the opportunities we have to launch an advanced reimbursement and pricing in key markets in Europe. Secondly, we think about we continue to extend our strategy of focusing on exclusives in the United States and market leadership. Or thirdly, how we expand our rest of world opportunity and maximize the number of patients on therapy in the rest of world via partnerships. So it's really as a result of understanding deeply the key investments we need to make in the business, as well as having confidence in our business and as a result of that, we have announced today the decision to conduct a share repurchase agreement, share repurchase program of up to $50 million which will be subject to shareholder approval under UK law. So that's a really important step.
And one of the things I've heard from investments -- investors in my five months with the company is they would really like us to show progress. Not just talk about it, but show progress. And I think the step and the confidence that we're demonstrating in announcing the buyback is very consistent with how we believe the strength of our business and the operating momentum we can drive in our company.
I may make comments about forward statements, so please review our SEC filings for full understanding of our business. So let's move to the agenda. First and foremost, I'd really like to share with you some of the core critical reasons to believe in our company and our strategy most fundamentally. Secondly, I hope you'll agree with me that we've made some very important momentum and very important progress in 2023, which has been a very important transitional year. And then thirdly, I'll talk about how we're taking that momentum into 2024 and building on that in our key areas. And naturally after, I'd be delighted to answer any questions you have.
So I've been with the company for five months. It's been a fascinating period of time. In speaking with customers, investors, our committed Amarin employees, our business partners around the world, there really are some very important fundamental reasons to believe in Amarin that really can drive impact to patients, impact for our customers, and therefore significant value for our shareholders. And that is really some of those core reasons that have led us to confidently announce our share repurchase program.
So fundamentally, when we think about Amarin and we think about VASCEPA and VAZKEPA. It can’t be -- it really can't be overestimated, the importance of just how compelling the science is supporting our product. VASCEPA/VAZKEPA delivers a 25% relative risk reduction impact on top of statins. In regards to numbers of needing to treat, that's 21, highly compelling scientific data. We've worked closely with our valued supply partners in negotiating supply agreements. We've taken difficult but important steps in right sizing operating expense in the company. We've continued to advance revenue. In Europe, we've continued to hold the line in the US and advance in the rest of the world. So as a result of that, we really closed the year with a very strong cash position of $321 million and no debt. That's demonstrating six quarters of continued strength.
As I mentioned in the EU, for the last six months, we've had new leadership in the EU and that new leadership has really brought, I would say, a different mindset of leading the region and a new strategy on how we can be truly focused in making the most of our European opportunity. As a result of that, it's really pleasing and encouraging. Today, we're announcing 65% growth in Q4 versus Q3, and that's driven really primarily by our launch uptake in Spain, as well as progressing our launch in the UK. And I'll share with you more about that. When we think about the EU, it's very important to think about the runway we have in the EU. We have patents and applications that have the potential to take us out to 2039. It gives us a substantial runway and opportunity for growth.
Here in the US, our business continues to show real resilience. It's a very atypical generic market. So here we are three years after generic entry, we have five generics in the market, yet we still command a 57% market share and market leadership. And indeed, that's founded on a very clear and compelling strategy focused on exclusive contracts, which we believe continues to be the right pathway forward for our US business, which is a very important cash and revenue generator for our global strategy.
When we think about rest of world, there are millions of patients that we have the opportunity to access with our important partners globally. As one example, in China, we have just now launched the very high triglyceride indication in China and we have had the, as I mentioned, the larger cardiovascular risk reduction indication accepted by the China FDA with a clinical trial waiver which is a very important milestone for the business via our partners, Eddingpharm. Underpinning that, we have an organization that's incredibly committed and I'll tell you a little bit more about it in the future. We have 300 people who are really committed to bringing value to patients and customers every single day, who have demonstrated great resilience. And it's on the basis of all these core reasons to believe that we confidently have announced our share buyback intention to conduct this year.
So our strategy is very focused and clear. Based on what I've shared, we have a significant opportunity to drive operational momentum and maximize the number of patients on VASCEPA or VAZKEPA. That requires us to take quite a different go-to-market strategy in each region. So, in Europe we're really focused on accelerating our uptake in revenue and unlocking pricing and reimbursement, particularly in EU5. In the US, it's all about extending our branded product life cycle and that's our focus with our exclusive contracts. With that said, given our very strong supply position in the US and depending on the market dynamics, we have the optionality of an authorized generic. And then lastly, in the rest of the world, via our partnerships, we're focused on maximizing the number of patients on therapy.
So if we go from the high level to really focus now on, okay, so what's the progress we've made in 2023? And we believe we've made important progress in this transitional year. So let me share with you more about that. The core of our progress is really some of our results. So in Europe, we've advanced the business 65% in Q4 versus Q3. Very important. Extending our market leadership in the US. And as I've touched on, new partnerships in the rest of the world including real progress in China. I often get asked the question from investors or partners, okay, you took the decision in July in the US to eliminate the sales force, your business in Europe is at very early stages and in the rest of the world you're working with partners, so how do you support these different regions? And one of the ways that we support our global business, our global commercial business very effectively is via our research and development and medical capabilities. So we think about the opportunity that the REDUCE-IT data has provided us to educate and to showcase the quality of the science behind our product. So a vast array of educational initiatives, focus at major congress and also continued regulatory approvals occurring on a global basis.
So as a result of that, you see our financials that we've pre-announced today, full year over $300 million in revenue, we've taken difficult decisions to right size our operating expenses, progressing our supply negotiations with our respected partners and as a result, we closed the year in a strong financial position, $321 million, $10 million in advance of last year and six quarters of continued progress.
I touched on our people and culture earlier and that's been one of the most important learnings for me. Coming into a business that has had, to be frank, significant turbulence, I wasn't sure what I would actually see. And what I've found is an organization that's incredibly committed and incredibly passionate about the value that we can bring to patients and our customers. So we recently conducted a global employee survey and some of the results that we encountered were really surprising and incredibly encouraging. As an example, 94% of our organization strongly agree or agree in their desire to go the extra mile to support the business and really show incredible commitment and engagement to support the business.
So let's zoom in a little bit more on 2023 progress. As I mentioned earlier, six months ago, we made an important leadership change in Europe. So we have new leadership and a new strategy that is delivering very encouraging early signs of growth. Still early stages for us in Europe, let's be honest, but encouraging signs of progress. That team and that leadership group have really brought, I'd say, thinking in three critical areas. Number one, I'd say a much more targeted and focused approach as we think about the patient segments and the customer segments that we focus on at launch. Secondly, a laser focus on resource allocation aligned to that segmentation with a more efficient operating model in Europe. And then thirdly, bringing much deeper and more succinct country-level insights on how we can align our value proposition to the payor-needs at a country level and being very focused there. So as a result of that, we're progressing importantly in the EU5 and we're demonstrating that impact in the EU5.
As examples, in Spain we launched in September. You may recall I shared in Q3 that we had about 500 patients on therapy in Spain at the end of Q3. We now estimate we have more than 1,700 patients in Spain, which demonstrates a really strong uptake and we're pleased with that and we're really only at the early stages. Secondly, we have more work to do in the UK. In Q3, I shared in the UK that we had around 1,000 patients on therapy. That demonstrated about a 30% increase in Q3 versus Q2. I'm encouraged to share with you that as we close Q4, we see that we've grown in Q4 versus Q3 in excess of 30% in pharmacy sales. When we think about EU5, obviously we're not only thinking about those two markets. So we're really thinking about how do we advance our opportunity in those markets that we really are still in the pricing and reimbursement process. So our focus in 2023 has been to, in Italy as an example, to build on the strong scientific assessment we have to strengthen those arguments that I'll touch on shortly for 2024. In France we've seen it's very critical for us to strengthen our arguments in clinical assessments. So we've really spent the time to develop those arguments in 2023. And in Germany, as I mentioned in Q3, we were working on a -- we've been working on a plan to re-enter Germany, given that we exited the market in the past. And I'll share with you more on that when I touch on 2024. In addition to that, across other markets in Europe, we have the opportunity to really continue reimbursement and pricing. We have seven markets that we're working on reimbursement and pricing submissions. So lots of important progress. As we move to the US, the US still provides a majority of our revenues, as you saw in our release this morning. And in Q4, the US is $64 million to $65 million revenue, which is very pleasing. It demonstrates stable Rx trends and an inventory rebalance to normal levels after it reduced in Q2.
This is not a new slide. We've shared this slide before. But what I really want to draw your attention to here is both the 57% market share and market leadership three years after generic entry. But secondly, and very importantly, due to the continued investments we place in managed care and trade capabilities, despite eliminating our sales force in July, we have maintained that 57% share stable for 12 months. That's a very atypical generic performance, and that's a very important performance to fuel our global strategy. So we're feeling very good about our US business as we close 2023 and think about 2024.
We've been busy in the rest of world. We've signed a number of new agreements as we think about how we maximize the number of patients on therapy. Of note, in Australia and New Zealand with CSL Seqirus and their advancing pricing reimbursement, in South Korea and ASEAN with Lotus, and also in China it's been incredibly pleasing for Eddingpharm to be launching with VHTG as I've mentioned. So important expansion work in 2023 and early stages of commercialization in Canada, Middle East, North Africa, and just starting in China, which we have a great opportunity to build more momentum for in 2024.
So what does that mean financially? I think financially it's a good story and I think we're really -- we are very encouraged and we're confident based on the results we've delivered in 2023. So our revenue, $72 million to $74 million. The US remains a predominant part of that. Beneath that, Europe you can see is still in early phases of development. With that said, we're encouraged by 65% growth quarter-on-quarter, gives us good reasons to believe as we move into 2024. And in rest of world, through our partners, you can see that we have a combination of supply shipments for our launching country in China as well as milestone payments associated with regulatory milestones. So good progress in rest of world. So as a result of that, strong cash balance at the end of the year, cash flow positive year-on-year of $10 million and demonstrating consistent cash management, which continues to be our focus. Obviously that's very important.
So I've kind of shared with you where we're at in terms of our strategy and our reasons to believe. I've talked to you about the momentum that's building in the business in 2023 in a very dynamic year for us. So what does that mean for 2024? And the reality is that we see very significant opportunities to accelerate our operational momentum in 2024. We've been declarative in stating our share price is significantly undervalued and we think we have a significant opportunity in 2024 to drive operational momentum and to impact patients, impact customers and therefore deliver value for our shareholders. So what does that look like? First and foremost, it's critical. And what you're seeing here in this communication is an increased focus and impact on EU5. So those initial launching markets, critical in 2024, that will continue to advance and deepen our success in both Spain as well as the United Kingdom. Secondly, very importantly, in those other three key markets around reimbursement and pricing, in Italy, we plan to resubmit, building on our strong clinical assessment in the coming weeks and we expect the reimbursement and pricing dialogue to conclude in 2024. As I've mentioned, in France, we've taken the time to strengthen our clinical arguments and progress our assessment with the payor in France and those will be submitted in 2024. We don't expect that conversation to conclude in 2024. And then lastly in Germany, building on prior comments, we now have spent the time to deeply assess how we could consider a reentry plan for Germany and we have a plan that we have developed which we are now working through when will be the right time in 2024 to resubmit. Also, that will not conclude -- to the best of our estimation, that will not conclude in 2024.
In addition to EU5, there's significant opportunity in the rest of Europe. So we think about those key launch markets. Netherlands, I've touched on before, Sweden and Finland, and then in other pricing reimbursement opportunities, and we have seven ongoing opportunities in 2024 and we expect to land five of those. Strong progress in Europe for us to build on in 2024. So you heard me mention about our US business and the durability and how we've been extending our branded life cycle in the US despite generic competition. What's underpinning that is our strategy, which we believe is compelling and we're proving it is compelling, in regards to our focus on exclusive accounts. Exclusive accounts in the United States represent about 50% of the total IPE market, and for us represent about 75% of our business. We closed 2023 feeling very good about that. We start 2024 therefore in a really good place.
With that said, let's also be very straightforward. The US is a genericized environment and really it is a highly dynamic market. So our focus is on retaining and extending the life cycle of branded VASCEPA. With that said, based on the dynamics, we do have the optionality to launch an authorized generic, which is particularly compelling given our strong supply position in the US.
As we think about the rest of world, building on my comments of how we've been signing new deals and early stage of commercialization, in 2024 provides us the opportunity to really start to shift and pivot from signing deals and entering agreements to strongly advancing access and strongly advancing uptake. And I think when we think about Canada, Middle East, North Africa, focus on revenue generation. When we think about China, huge opportunity with our launch with very high triglycerides. We expect to be progressing reimbursement and pricing with our important opportunity in Australia, New Zealand with CSL Seqirus. And so really when we think about, we have a great opportunity to progress our opportunity in the rest of world and maximize the number of patients on therapy and really move up and delivering more value from the rest of world in 2024.
So lastly when we think about the progress that we're making in 2023, which we believe really sets us up well for a strong 2024, we're confident in 2024, we know the investments we need to make in the business, we're focused on delivering value for our shareholders. It's very clear to us that our share price is significantly undervalued. And as a result of that, we made the announcement earlier today that we will initiate a share repurchase program up to $50 million this year. A little bit on that, it is subject to UK law and subject to our shareholder approval. So we will be promptly working through those next steps such as our AGM and then working with our shareholders on that approval and then working with our banker to really expedite that and commencing in 2024.
So with that, thank you so much for your time, and I'd love to answer any questions you have.
Question-and-Answer Session
Q - Jess Fye
Great. Thanks so much for the presentation. Let's stick with that last topic of the share repo. Can you touch a little bit more on the timing for starting and then potentially concluding that repo and maybe elaborate just a little bit on kind of what gives you the confidence to do that now?
Pat Holt
Yeah. Thanks, Jess. So I think to answer the second part of the question first, fundamentally when we look at the progress that we've made in the business in 2023, when we look at the key investments we need to make in the business in 2024, particularly in Europe and we think of the momentum we're creating in the business, we're really confident in the resources that we have to support the business. So in the interest of how we create value for shareholders, it's compelling to us, and not just talk about it, but show the strength that we have in the business in announcing the repurchase. In terms of timing, we are subject to UK law, so that brings some really important steps in the process. Firstly, we need to obtain shareholder approval. We will expedite our AGM, which will -- to occur sometime in Q2. So we expect to complete the process within the second quarter, and then we will begin the actual repurchase thereafter, which is likely to take us into early 2025.
Jess Fye
And when you talk about maintaining icosapent ethyl leadership as a priority in the US, I guess I would think that we can't really decouple that from preserving overall value. So I'm curious, kind of, is the priority on share, or is that kind of a misinterpretation or simplification, or is the priority more on value?
Pat Holt
Great question. The priority is on value. The priority is on revenue and cash. The strategy to date, which we believe continues to be compelling, is to focus on the branded VASCEPA, focus entirely on our exclusive contracts. With that said, depending on those market dynamics, there may become a point where a more valuable and a more impactful approach for cash and for revenue and profits is to move to an authorized generic. So it will just depend upon those dynamics, which are particularly pricing led as to how we will assess that. It's worth noting that through 2024, we will expect to see headwind on price in our exclusive agreements to retain them and I'd ask folks to think about them in that low double digit range of pricing headwind to retain our exclusive contracts, as well as some volume impact in the non-exclusive segment of the market, which is a little bit over 20% of the business. But at the end of the day, this is about life cycle management. It's about retaining the greatest amount of revenue, profit, and cash that fuels our global strategy.
Jess Fye
And I guess, while we're on that point, you mentioned kind of the anticipated price pressure to maintain those contracts in the US. If things kind of play out as you expect, what -- I guess, what triggers the move to an AG?
Pat Holt
Yeah, great question. So we spent a lot of time working on different scenarios. The fundamental of our business in the US is it is genericized and there are a number of generics in the market. So really it will depend largely on how those pricing dynamics play out in the marketplace. And really tracking the pricing dynamics, as an example, if we were to start to see a deterioration of our exclusive positions, that will be something that is one of those things that we're watching for. So our focus is on maximizing and extending the brand as long as we can, but we're in a very strong position, given our supply position and our plans in place to pivot to an AG if that is more compelling. But it really will depend upon primarily the pricing dynamics within the entire IP market in the US, which naturally we have little control on.
Jess Fye
Okay. And maybe the last one on the US, I think you called it not only a revenue generator, but a cash generator. Anything you can say about how much cash that business is generating?
Pat Holt
We don't talk about it specifically, but naturally, you can think about that US business being significantly profitable that is then fueling the investments that we make in Europe. And so net-net, we're demonstrating that we're cash flow neutral to cash flow positive for six quarters. So you can think about it that the profits from the US business are really fueling the investments we're making in Europe, such that net-net, we're sustaining those investments and cash flow positive and for the last six quarters and strong cash position of $321 million.
Jess Fye
Got it. Maybe turning to the pre-announced results today, it looks like a strong number, at least relative to our expectation. Anything in particular driving that kind of sequential increase in the US? Any channel inventory changes we should be aware of?
Pat Holt
Great question. So if you look at -- thank you for asking that question. When you look at the US, I'd say there are two elements. The most important element in the US revenue, if you recall, inventory levels in Q2 went down notably. They stayed at those levels in Q4 -- Q3, sorry, and they've now returned to normal levels. So there's a slight rebalancing of inventory in Q4 in the US. And also we have seen stable Rx trends in the US business, as you've seen by maintaining 57% share through the year.
Jess Fye
Are you quantifying the inventory contribution?
Pat Holt
Not specifically. We're in the process. We have our full results in coming weeks. We'll be able to share more on that.
Jess Fye
Great. So switching to Europe, I mean, starting with the UK, maybe I shouldn't say Europe, I think you mentioned kind of more work to do, 1,000 patients as of the end of Q3, and that pharmacy sales grew quarter-over-quarter. When you talk about more, what is the more work to do there?
Pat Holt
Yeah. So when we think about the different markets in Europe, each market has very specific nuance. When we think about Spain, Spain is typically a fairly rapid uptake market and we're demonstrating that in how quickly we're launching in Spain and we're pleased with the progress. The UK typically is a longer market to turn on. It's much more an account management based market. So the work that we're doing in the UK is to really focus on each of the key accounts in the market and work through the process of really turning on prescribing, turning on uptake. In some examples, that requires us to set up specific pathways, clinical pathways, within each account. So it's actually much more time consuming and different processes need to occur in different accounts to actually get to that point of driving the physician prescribing uptake. We are seeing progress in the UK. As I mentioned in Q3, 30% increase in pharmacy sales versus Q2, and in Q4, we're seeing greater than 30% increase. But I wouldn't say that we're satisfied with UK. I think we have more work to do.
Jess Fye
And then in France, you talked about strengthening the arguments the company is making on clinical assessments. I'm kind of struggling with what the disconnect would be with a data set like REDUCE-IT, with the NNT that you mentioned. So, like, what is there to strengthen here?
Pat Holt
Yeah. Look, one of the interesting things about Europe is if you understand one European payor, you understand one European payor. So each of those markets have a very individual and very nuanced and specific way of assessing clinical data. So what we've found as we're in the process is, we do have a rich data set with the REDUCE-IT data, but we have the opportunity to add some additional arguments to that. And we need to do that to ensure that we land in the right clinical assessment, which then has a consequence in the pricing and reimbursement discussion. So what we've learned through that process is there is an important opportunity for us to strengthen our arguments around how we present the REDUCE-IT data and the various subset and how we present data such as updates to ESC guidelines and other data that can strengthen the clinical arguments that we have with the French payor. That's not unique to Amarin, but it is certainly something that we're experiencing.
Jess Fye
Got it.
Pat Holt
So we've spent a lot of time to really get, I'd say, more detailed country-level understanding on those requirements and then building those arguments in a very sequential way so that we're ready to resubmit -- ready to submit and advance our submission in 2024.
Jess Fye
[Switching] (ph) to Germany, where it sounds like you've kind of landed on a plan on how to re-enter but are thinking about the timing, what factors into the timing when you start executing on that plan?
Pat Holt
So I think that's a great question. There's a few things. One, I think learning from our previous experience, we need to ensure that we have a very clear targeted strategy, understanding the GBA, understanding the German payors needs at a very granular level. So that's work that we've been doing to truly understand that the core needs of the payor. Secondly, then it takes time to really develop those arguments and working with third parties to understand how we can put those arguments forward. And then there are various points of getting input and getting feedback from the payor. So it's really based on those various points of input that we will receive, then we'll have a view as to when is the right time to submit. And we believe that will be in 2024.
Jess Fye
Okay.
Pat Holt
But the most important thing about Germany is we've gone from really being out of the market and not clear on what is a forward pathway to now having a pathway that we feel will be compelling and we're focused on advancing that.
Jess Fye
Got it. So, in Italy I think you mentioned resubmission coming up just in a couple weeks and that kind of process concluding in 2024.
Pat Holt
Indeed.
Jess Fye
Once you have reimbursement in Italy, should we think of that market as more similar to kind of the rapid uptake Spain scenario or the kind of account by account UK scenario?
Pat Holt
Yeah, great question. You might not like my answer, it's probably somewhere between. It's not quite the same speed of Spain but it's certainly not as arduous as the UK. So that's something that we'll understand more as we launch upon the decision in 2024. But it would be somewhere in between.
Jess Fye
Got it. Maybe with the last bit of time here, just kind of a high level question. But what is it that you want investors to better understand about the Amarin story?
Pat Holt
I think fundamentally, I think to understand, one, that the science is compelling. Two, we are making progress and we're strengthening our business in Europe and the launching countries and also reimbursement and pricing elsewhere. Three, the US continues to deliver significant profits and cash flows for our global strategy and we're extending that life cycle. And finally, we have a significant opportunity in the rest of the world. So holistically, we have many opportunities to deliver significant value for shareholders. And quite frankly, our current share price is really not demonstrating that value that we can bring for shareholders. And I think the other thing I'd say is that fundamentally, we've -- despite having a somewhat turbulent year in 2023, we've retained our key talent. We have a highly committed organization that's focused on bringing value to our customers and patients. And we take it personally, what's happened to our share price, and it's something that means a lot to us as a team and as individuals. So we're really committed to really bringing value to all of our stakeholders.
Jess Fye
Great, we'll leave it there. Thank you.
Pat Holt
Thank you very much.
Mufaso, thanks for your continued DD on VKTX. Have you seen the following:
Merck chief executive officer Rob Davis said that the company is looking at a new class of weight loss drugs called glucagon-like peptide 1 (GLP-1) that provide health benefits for diabetes and other disorders alongside weight loss.
The New Jersey-based pharmaceutical company is seeking opportunities through its own drug development as well as deals.
GLP-1 drugs, like Novo Nordisk's (NVO) Wegovy and Ozempic and Eli Lilly's (LLY) Mounjaro and Zepbound, work by controlling blood sugar levels and triggering a feeling of fullness. Other than weight loss, GLP-1 treatments are also being tested against other conditions such as chronic kidney disease and cardiovascular disease.
Davis believes that GLP-1 therapies offering benefits beyond weight loss will potentially make it easier to get reimbursement for the drugs. He said, "I think everyone recognizes weight management is a hard thing to get reimbursed. But if you can show cardiovascular outcome, if you can show diabetes outcome, which you're starting to see data for, if you can see fatty liver disease benefits...that is an area where we think there's opportunity."
https://seekingalpha.com/news/4052559-merck-looks-to-tap-into-obesity-drug-market
Denner increased position.
Dew, the WSJ article quoted the following:
"Peredo, who conducts trainings for AbbVie and Galderma and has a vanity plate that spells BOTOX, says nearly all of her patients are satisfied with Daxxify. She calls each treatment a “spicy Daxxi” because she says the injection stings."
Do you know if Daxxify stings more than Botox? TIA.
Cap, thanks for your continued diligent tracking! Is 95,084 the number of V pills dispensed in June? If yes, it would translate to 792 bottles. TIA.
More importantly. "Delivered Positive Cash Flow of $9 Million in the Quarter with a Cash Position of $313 Million --"
new CEO
Restructuring news.
AMRN halted for news
Biogen shareholders back Susan Langer as director:
https://www.reuters.com/business/healthcare-pharmaceuticals/biogen-shareholders-back-susan-langer-director-2023-06-26/
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