Amur Minerals Corporation

Good morning, everyone, and thank you for joining us. Turning to our forward-looking statements. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided under federal securities law. We may not achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures, or any material agreements that we may enter into, amend, or terminate. For additional information concerning the risk factors that could cause actual results to differ materially, please see the Risk Factors section of our annual report on Form 10-K for the year ended December 31, 2023, which has been filed with the SEC and is available through the Investor Relations section of our website at www.amerincorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Ameren's website in the Investor Relations section. Turning to today's agenda, Patrick Holt, Ameren's President and Chief Executive Officer, will provide a brief overview of 2023 highlights and 2024 priorities, and Tom Riley, Ameren's Chief Financial Officer, will provide a review of our fourth quarter and full year 2023 financial results. Following prepared remarks, we will open the call to your questions. I will now turn the call over to Patrick Holt, President and Chief Executive Officer of Ameren.

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 Ameren. Every day, our team is focused on driving operational momentum to maximize the patient's uptake of the SEPA Bascapa. To enhance the value of Ameren 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 the 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 Ameren and will more strongly position us for potential future options. Turning to slide six, 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 healthcare 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 EU5 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'll continue to communicate progress on France and Germany as additional steps are achieved. Importantly, we are also aiming to successfully conclude pricing and reimbursement decisions 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 the CBA'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 IPE 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 pay-or-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 the SEPA in October for the very high triglyceride indication. Additionally, the 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, Ameren 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 Reducit and EPA. Indeed, we have seven abstracts at the upcoming American College of Cardiology meeting in April. We'll be sharing 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 Operation 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 Riley to review our fourth quarter and year-end 2023 financial performance.

Tom. 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, AMRI 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 U.S. product revenue was $64.9 million, with stable performance in the U.S. despite multiple competing generics on the market. The U.S. business continues to provide profits supporting our expansion into Europe. The revenue results include Europe PM 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 the 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 milestone. 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. Ameren's overall gross margin on net product revenue in the fourth quarter was 58 percent, compared with 64 percent in the third quarter of 2023. This was primarily due to an increase in launch 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 in general and administrative expenses, and $5.8 million in research and development expenses. In the second half of 2023, AMRI 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. AMRI 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 31, 2023, AMRI reported aggregate cash and investments of $321 million. Importantly, this is the sixth consecutive quarter of positive or neutral cash flow generation for Ameren, and our cash balance is now $10 million higher when compared to December 31, 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.