Q4 2022 Amarin Corporation PLC Earnings Call
Speaker 2: Welcome to Ameren Corporation's conference call to discuss its fourth quarter in full year 2022 financial results and operational updates. I would like to turn the conference call over to Lisa DeFrancesco, Senior Vice President, investor relations and corporate affairs at Ameren.
Speaker 3: Thank you, Holly. Good morning, everyone, and thank you for joining us. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the State Harbor provided under the federal securities law.
Speaker 3: We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statement. Actual results or events could differ materially, so you should not place under-reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements.
Speaker 3: We encourage everyone to read these documents. The call is intended for investors in Ameren and is not intended to promote the use of the SIPA or the SCEPA. An archive of this call will be posted on Ameren's website in the investor relations section. Green Mecail, Ameren's president and chief executive officer, will lead our discussion and Tom Riley, Ameren's chief financial officer, will provide a more detailed review about this cake
Speaker 4: of our fourth quarter 2022 financial results. After prepared remarks, we will open the call to your questions. I will now turn the call over to Karim Mikael, President and Chief Executive Officer of Ameren. Karim. Thank you, Lisa. Good morning and thank you all for joining us today. While 2022 was a challenging year for Ameren, it was also a year filled with significant accomplishments that we believe have created the foundation for our future and gives us confidence that 2023 will be a year of tremendous evolution for the company. We're only beginning to see the results of the actions we took in 2022 and already in 2023.
Speaker 4: Throughout the remainder of this year, as each piece falls into place, we will be able to see more clearly the successful turnaround and the growing business that we have been building internationally. Ameren is in a unique position. As we are building value for a product outside of the US, while facing increasing generic competition in the US market, our company is made up of people who come to work every day, because they believe in our bold vision to stop cardiovascular disease from being a leading cause of death. This vision is what drives us. I'm proud of this team and what we have been able to accomplish together. And I'm excited for what we are able of accomplishing in the future as we continue to execute on our strategy.
Speaker 4: Today, I will briefly summarize the actions that we took in 2022 in the spirit of operational excellence to create value over the long term and bring the SEPA to as many eligible patients as possible across the globe. I will also provide an update on our launch in the UK and where we stand with our plans for global expansion. I will provide an update on our results in the US where the team's efforts to stabilize this business is providing the support for our global commercialization efforts. I will then briefly discuss Ameren's presence at the upcoming ACC meeting. Tom will then discuss our financial results for the fourth quarter and our guidance for 2023. And I will conclude with a look ahead at the remainder of 2023. In 2022, we focused on three main areas.
Speaker 4: global commercialization, preserving our cash, and ensuring that we have the right talent to execute on our new global strategy. We began the year 2022 negotiating pricing in one market in Europe and ended the year with our product available in five European markets. Since the beginning of 2023, we have added a sixth country with Switzerland, where we have received individual reimbursement in February . We also have an additional five European markets in advanced stages of pricing and reimbursement negotiations. Our objective is to conclude the vast majority by the end of 2023.
Speaker 4: as we focus on building a diverse and sustainable revenue stream in Europe . In Spain, we remain active in the reimbursement process and are confident in our ability to secure pricing in this market. We have gone through two rounds of review and made solid progress. We anticipate a potential third round of review imminently. In the Netherlands and Italy, we are in advanced stages of our price negotiations and are optimistic a decision could come around mid-year for these markets. We're also making good progress in France, which typically can take slightly longer than the other markets based on historical benchmarks. Other markets such as Norway, Portugal, Israel, and others are also progressing with potential decisions expected this year.
Speaker 4: We focused on preserving our cash. In the first quarter of 2022, we saw almost $100 million in cash burn. With new members on our management team, we took swift action to renegotiate supply purchase arrangements. We also implemented a comprehensive cost saving plan in June . And today we are excited to announce that we are on track to exceed our $100 million cost saving target. Thanks to our continued fiscal discipline and cost cutting efforts, which Tom will discuss in more details later in the call. These actions resulted in a cash flow positive fourth quarter in a year and cash balance of more than $300 million.
Speaker 4: And lastly, we also built a strong European commercial organization with expertise in medical affairs, product launches, and with extensive cardiovascular product knowledge. Many of our team members come from companies where they successfully commercialize blockbuster drugs and have significant contacts, expertise, and knowledge of their respective markets. These professionals came to Ameren because of our leading product, our unmatched data, and our entrepreneurial culture. And they are utilizing their background and leveraging their experience to build the Ameren business and brand in Europe . This European team also benefited from the valuable experience that our US colleagues had building the brand successfully over several years in the US market. I'd like now to focus on providing an update on the UK. First, I think it's useful to provide a reminder of the key highlights. We completed our NICE application in July of 2021.
Speaker 4: across the cardio metabolic spectrum of products in the UK.
Speaker 4: When we look at the market access picture of Vaskepa in the UK, initial market access is trending ahead of other recent compatible launches in the market. Our team has unlocked 19 out of the first 20 priority accounts, which collectively represents 50 percent of the eligible patient population for Vaskepa in the UK. As a reminder, the UK is a market that has a historically slower growing initially in terms of revenue. Based on these trends and the price achieved, we believe there is a viable, strong and long-term business opportunity for Vaskepa.
Speaker 4: distribution agreement with CSL Sequeres in Australia and New Zealand. We are excited to announce this agreement with CSL Sequeres, a world-class pharmaceutical licensing and distribution partner. CSL Sequeres brings highly experienced market access and commercialization teams in Australia and New Zealand that are well positioned to support pricing and reimbursement efforts.
Speaker 4: for Vaskepa, particularly with their strong record in successfully supporting pharmaceutical benefits listings and eventual marketing and promotion to help us to deliver this important medicine to patients in these countries. Importantly, both Australia and New Zealand contributed significant number of patients to reduce it, so it is gratifying to know that we are moving in the direction of giving patients and physicians access to the product there.
Speaker 4: We expect the next wave of approvals to include China through our partner Edding Farm. Regarding China, our partner Edding Farm is in charge of the regulatory review process. In their latest update, Edding indicated they expect an approval by mid-year as a result of delays related to the shutdown of the regulatory process in China for a period of time due to COVID-19 restrictions. We are working very closely with Edding to ensure we have the latest updates from our partner. As of today, we have not received any indication that there are any open questions or concerns regarding the regulatory filing for our product. In Canada, HLS Therapeutics.
Speaker 4: has obtained reimbursement from all major private and public payers, gaining access to a majority of eligible patients in Canada. HLS continues to be in the launch phase in the public sector, and they are seeing stronger growth for the product in provinces where public access was secured. We're also actively negotiating potential agreements in the Asia-Pacific and Central-Eastern European regions which would enable us to get this important product into the hands of clinicians and patients, and ensure we can extract value from these important markets. I'm pleased with the progress we've made advancing our international expansion plans.
Speaker 4: We remain focused on our core future objective, which is global growth and expansion for the SIPA, VESCEPA in Europe and internationally. As we believe expansion is the key to creating value for shareholders. We remain confident in the multi-billion dollar market opportunity for the SIPA, VESCEPA in Europe and internationally. Moving to our US business and our plans for ECC 2023, in the fourth quarter of 2022, we recorded $90.2 million in total net revenue, including $88 million in US product sales. In line with last quarter, despite the continued pressure from generic competition. This is the fourth quarter of four consecutive quarters of revenue stabilization in the US in 2022. This unique achievement was only possible through the relentless dedication and efforts of our highly experienced US team on the field and with the managed care organizations.
Speaker 4: We are continuing to maintain our share in the IPE market. Our trends in January and February support continued stabilization of the business. In the first quarter, we're experiencing typical pharma seasonal trends that branded products like the CPAK can expect in the US from fourth quarter to first quarter, driven by co-pays and deductibles resetting for patients and their health care plans with a new calendar year. We also expect to see some continued price erosion this year as we continue to experience generic competition. Tom will talk in more details about what we can expect shortly. One compelling fact is that our US team has generated more than $1 billion in sales since generic launched in 2020. We continue to have multiple levers we can consider to maintain our profitability. As I mentioned earlier, our cost savings are ahead of plan, and we have the ability to launch either a brand generic or an authorized genetic as needed and at the right time.
Speaker 4: While we are planning carefully for all potential scenarios, it is clear today that the strong and nimble infrastructure we retained in the US provides us with the right team to continue to support business stabilization in the near term. Lastly, we continue to benefit from the strong data that we have generated with reducing. Four abstracts were accepted and will be presented at the American College of Cardiology, meeting taking place later this week in New Orleans. We are excited to share new findings from the reduce a trial that add to the wealth of data that has consistently validated the utility of the CPA and treating patients sub-populations at high risk of cardiovascular disease. This important information coupled with the analyses comparing the antioxidant effects of EPA, DHA, mineral oil, and corn oil, should help advance the medical community's understanding of the role and value of the CPA and EPA to reduce cardiovascular events in at-risk patients globally.
Speaker 5: We remain committed to investing in our data and our medical presence with a global focus to support the medical education efforts for the launches of the seat around the world. With that alternate over to Tom to talk more about our progress and strong results this quarter. Thank you. Good morning. Everyone. I'm pleased to report additional details on our financial performance for the 4th quarter. In full year, 2022 following our pre announcement. In January , let me begin by discussing our revenue performance. For the 4th quarter of 2022, we reported total net revenue of 90.2Million. Including net product revenue of 89.5Million, a decrease of 38% compared to the 4th quarter of 2021. US product revenue was 88Million. In line with the 3rd quarter of 2022. Reflecting relatively stable trend in volume. We remain pleased the stable trends in spite of multiple competing generics on the market. The US business continues to generate a positive contribution margin.
Speaker 5: and provides necessary financial support for expansion in Europe and other geographies around the world. Results included international product revenue of 1.5 million, which includes European product revenue of 0.3 million, beginning to reflect very early revenues from the UK. Cost of goods sold for the three months ended December 31, 2022, was 26.6 million compared to 30.6 million in the corresponding period of 2021. Gross margin was 70.3% for the three months ended December 31, 2022, compared to 78.7% in Q4 2021 as a result of lower U.S. mid-selling price. Now moving on to operating expenses.
Speaker 5: During the fourth quarter of 2022, we reported the expenses of 73.2 million compared to 97.7 million in the fourth quarter of 2021, a decrease of 24.5 million or 25 percent. The decrease compared to last year includes the impact of the cost-saving initiative announced in June of 2022. These savings were partially offset by our investments in growth and expansion in Europe . Under US GAAP, Amarin reported net income of 0.9 million for the fourth quarter of 2022 or basic and dilute loss per share of zero. As of December 31, 2022, Amarin reported aggregate cash and investments of 310.6 million in demonstrating the cash positive for the fourth quarter of 2022. We continue to experience relatively stable trends in our US business. Currently, we are not seeing any significant impact from TEBA's listing of a one-gram generic version of the SEPA. We do expect our US revenues for the first quarter of 2023 to reflect the impact of typical branded seasonality resulting in first quarter revenues slightly lower than the fourth quarter. We do expect the Earth to reflect continued pressure on the world.
Speaker 5: both prescriptions and also price, as we work to retain key customers to the brand. We've continued to make progress against our cost reduction program announced in June of 2022, and we are on track to exceed the 100 million cost savings target we announced in mid 2022. For the full year of 2023, we now expect the operating expenses to be between 290 to 305 million, compared with approximately the 350 million originally anticipated at the time of our June 2022 cost savings announcement. The lower than anticipated expenses are result of additional initiatives taken across the organization to reduce costs, along with the timing of our European investments, where we committed to invest carefully in Europe ahead of reimbursement decisions. Since the cost savings announcements in June , we have taken significant steps this year to strengthen and streamline the company operationally.
Speaker 4: In addition, we have made significant progress in amending our supply agreements, and those negotiations are still ongoing. With these initiatives and relatively stable trends in the U.S., we believe our current available cash and resources, including U.S. profitability, are adequate to support continued operations, including European launch activities. Now with that, I will turn the call back to Kareem for closing remarks. Kareem? Thank you, Tom, for that financial overview and our results during the fourth quarter. We exited 2022 with a strong foundation to support our future growth plans as we focus on becoming a global diversified cardio-metabolic player. And we are off to a strong start in 2023. We have a very clear set of priorities. Our first and main objective is to conclude reimbursement discussions successfully in the remaining European markets and launch. We will do this while remaining laser-focused on our cash preservation efforts. We're just beginning to see the results of our efforts over the last 18 months. Gaining pricing and reimbursement in Europe remains critical for a strong sustainable future and shareholder value creation. We would also like to take a moment to address Ameren's general meeting that was held yesterday, the results of which were disclosed after market close.
Speaker 2: operator, we're ready to take questions. Certainly. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.
Speaker 6: to break out European sales in your future reporting. And secondly, on Germany, I think you have mentioned that you plan to submit another dossier to Germany. Maybe remind us what the process looks like and how we should think about the timeline. Thank you. Thank you for the question. We'll start with the UK launch. So as you've seen,
Speaker 4: It is difficult that any company, by the way, shares very specific metrics of a country launch. We decided to do that since UK is one of our first big market launches, and we believe that there is value for shareholders to stay very close to these metrics. What we have presented today is data showing the formulary listing, which is really the most important step to opening the door for physicians to prescribe, for the product, it demonstrates that the product availability is real for a very large majority of patients. Now, in terms of future results, we will try as much as possible to share more metrics, hopefully also from a revenue perspective at the right moment. Having said that, a breakout of reporting between countries in Europe is not a very customary thing and I think would not help us, honestly, in terms of negotiating prices and maintaining proper working relationship with the reimbursement agencies. But our intent is to share as much as possible, especially on the UK as the first country launch. For Germany resubmission, yes, this is the plan to go back to Germany because we believe that the German patients deserve.
Speaker 4: to use the CPA, but we believe the timing for this would have better chances of success after other large markets approving the product. So once we have Spain, Italy, France, it will probably be a better time to submit the file and at that point in time, we will have a stronger dossier to submit. But thank you for the question. We're not giving up on Germany, we will keep trying. Thank you, that's very helpful. Thank you so much. Thank you. Your next question is coming from Ruana Ruiz at SVB Securities. Hi, morning everyone. So wanted to check in about the US a little bit. So what's your level of confidence in your inclusive contracts holding up this year and do you expect revenue stabilization to continue through most of 2023? Thank you, Ruana. So on the US, if you remember the exclusive journey started really in July of 2021. So this is not something that the team started working on this last quarter. Over the last 18 months, we were able to sustain our volume from the exclusive stable over six quarters. So there's definitely a very solid foundation, but we are in an open market where there is competition. Now we have a fourth entrance which listed, but it's not yet available on the market. So we feel confident that the foundation that we have established is stable. We already communicated in our comments and we hope there's currently a near future chance that the primary market will continue to help the foundation move toward the next mainframe. So moving on, what is your view on theoffensive and developing strategies for fulfilling a broad range of Hope Councilstay?
Speaker 4: We're going to see some erosion on the price. We're going to see a typical erosion on volume that we've seen quarter over quarter. We're ready for multiple scenarios. If we have from the beginning, assume that this market is going to act like a typical generic market, and we're going to lose 90 percent of the business. By now, we would not have sold the $1 billion that we sold. We continue to keep four fingers on the pulse. We stay very close. For the moment, the situation is stable. We have not lost any of these exclusives. We are in a stable position. But if there are threats, we have a plan, and we will act swiftly on this plan if need be to maintain US profitability. Got it. Thanks. Thanks for clarifying. So I wanted to also ask about Europe a little. So I think on the call you mentioned Italy might have a reimbursement decision mid-year, and France and Spain may possibly come online too. So I was curious, will you be ready to immediately launch in these regions after getting decisions? Or just curious what the rollout might look like for Vescapa there. Yeah, so first of all, let me clarify. I mean, you mentioned three countries. Those three countries have very different processes and very different timelines. So in Spain, we try to be as clear as possible that we've had two rounds of negotiation. We are.
Speaker 4: Starting a third round of negotiations, so this is imminent as we described it, at least based on where we are in terms of negotiation. Italy, the process is less structured and the way it's progressing, current estimation is maybe by mid-year, France usually takes longer time, right? In terms of arriving to an agreed upon price. Agreed upon price. But in those three markets, the minute we're gonna have reimbursement, we will be ready for launch. And those markets differ in Spain, you have a lot of sort of regional market access, which by the way, we have also made progress with just to ensure we are ready to launch when we have a Spanish price. In France, it's a very nationally driven system, so there are no regional access. So hurdles, so the minute we're gonna have a French price, we're gonna be launching to really, the major primary care population and it's a significant market, but France takes longer time based on benchmarks that we have, so we're working on the three of them. Understood, thanks a lot. Thank you. Your next question for today is coming from Louise Chen at Cancer. Hi, thanks for taking my question. So I wanted to ask you how committed you are to seeing cash flow break even and how feasible is that given generics?
Speaker 4: and also incremental burn with each new European approval. Thank you, Louis. So, you know, 2022, we had a very clear vision to turn around the cash burn situation from the 100 million to the cash flow positive that you've seen. Now we're entering a different phase, right? Because we have a number of milestones that we are gonna have in 2023, especially with European launches. With those European launches, you know, there will be a necessity to invest. So the situation will change quarter to quarter, but there are also other variables that impact our cash flow. And I'll let Tom maybe talk more about that.
Speaker 5: Yes, so overall cash flow, we overall, our guidance is that we have enough cash and cash equivalents to get to you, to profitability, to support the European launches. What we expect is for 2023, depending on the situation, what we expect is that we will have a decline in cash balance. There's going to be ebbs and flows between particular quarters, right? And so we will not be coming in cash positive every quarter, but more of an ebbs and flows. As you recall, we took specific initiatives last year on the supply chain. We still have negotiations taking place and the cost savings initiatives as well. Yeah. And of course, you've heard us.
Speaker 4: delivering above plan in terms of OPEX and the savings, right, which is a significant number, and big part will also depend on the stabilization of the US. So, we are very clear on what are the key drivers of maintaining our cash position, whether it is the US business, our level of OPEX, which we are making far more additional efforts to try to save money, but if we are going to spend a bit more, it will be good news because it means we have more European markets that are joining the launch phase. It is important to note that a lot of our European expenses are already built in and big within these numbers, right? So, you have seen on some of our slides, we talk about overall head count in Europe today.
Speaker 4: Today is day one. We're in very early stages of onboarding. But I mean, for the moment, our strategy is very clear. Shareholder value creation is about expanding and launching and succeeding in Europe while maintaining the profitability in the US, because that's necessary for us to make it there. So these are the key priorities. For the moment.
Speaker 4: We have not had any shift in strategy, but as management, we have always been very open to reevaluate what's happening in the market and what we need to do. Because if you look at what happened in the market over the last two to three years, things have developed and evolved significantly. So we stay very open to the market, to the situation.
Speaker 4: and to adapt our plans and our strategies accordingly. But for the moment, I believe we have a clear path to the future and moving ahead. Thank you, thank you for the question, thank you. Your next question for today is coming from Narash Chohan at Intron Health.
Speaker 2: We can't hear a question. Just one moment. Naresh, your line is live.
Speaker 7: Thank you, can you hear me now? Yes. Yep, great. So three questions please. Firstly on G&A, can you help us understand what's in here? It's 25-30% of sales. Trying to get a sense of what's in there and where we should expect that to go over time. On COGS, they were quite a bit higher on our estimates, that's 300 baseboards higher than we could sense on Q4.
Speaker 4: and secondary discounts and material, and we should be considering those. Or if you're pretty close to the price, things will set by nice. Thank you. Thank you, Maurice, for the questions. I'll let Tom handle the GNA sort of overview and the COGS, and I'm gonna deal with sort of the price, net price and potential discounts and so on.
Speaker 5: Sure, so, you know, thanks for the question. So, in general, in the GNA, what's within that line item, it's our corporate expenses to support the organization in there as well. We have legal-based expenses.
Speaker 5: We have insurance charges are related to our overall programs from a program management from a risk perspective. So that's what's in our G and A. On your question related to cost of goods and on and the increase on margin of a proximate 0.3. It really comes down to a sales mix. So it comes down to U.S. product sales.
Speaker 5: versus mix of some of our product revenue that we have with some of our collaborative partners. So overall, I think the root cause, the root of your question was, were there any inflation impact? And the short answer to that is no, there was not inflation impact. And on the positive side, from the working capital perspective, we burned down quite a bit of inventory, given the overall supply negotiations that we've taken and continue to onboard with.
Speaker 4: Karim, would you like to answer the last question? Yeah, for the UK price, so you've seen from the slide that we put the prices of the multiple cartoon metabolic oral drugs in the UK on the list level. We're very conscious that some of these list prices for other benchmarks is not really the net, meaning that some of them are even discounting further to NHS,
Speaker 4: to basically gain access. Where do we stand today and based on our agreement? We are actually not discounting from this number that you see to NHS. So this is for us a big part of the strategy of why we believe that the negotiation we've had was very successful because we convinced nice of the value of the product and that it was not necessary for us to be discussed.
Speaker 4: See and visualize our price in the UK and they understand exactly what the British government is paying for amaron, for the. That's great, Thank you. Thank you, urch. We have reached the end of the question and answer session and I will now turn.