Amur Minerals Corporation

Welcome to Ameren Corporation's conference call to discuss its second quarter 2024 business update and financial results. I would now like to turn the conference call over to Mark Marmer, Vice President Corporate Communications and Investor Relations at Ameren.

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 31st, 2023, and our quarterly report on Form 10-Q for the quarter ended June 30th, 2024, which has been filed with the SEC and is available through the investor relations section of our website at www.amroncorp.com. We encourage everyone to read these documents. An archive of this call will be posted on Amron's website in the investor relations section. Turning to today's agenda, Aaron Berg, Ameren's President and Chief Executive Officer, will provide an overview of his perspectives on Ameren's value and second quarter business progress. And Tom Riley, Ameren's Chief Financial Officer, will provide a review of our second quarter 2024 financial results. At the end of the presentation, there will be the chance to ask questions. I will now turn the call over to Aaron Berg, President and Chief Executive Officer of Ameren. Aaron.

Thank you, Mark. Good morning, everyone, and thank you for joining us today. I'm thrilled to be back leading Ameren in a very short time. As interim CEO last year, I was able to spearhead several key global strategic and organizational adjustments. Now back in the CEO role for just a few short weeks, it's gratifying to see some of the impact of those changes. I've been with Ameren for over a decade and remain as passionate and committed to the company as when I started for several very important reasons. First of all, the SEPA-Viskepa is an incredible product. Over the last 10 years, more than 300 scientific publications have been generated confirming the unique attributes of the SEPA, anchored by the landmark REDUCE-IT trial, confirming that the SEPA provides an important option for patients globally who need to reduce their risk of a cardiovascular event. I ran the U.S. commercial organization when the REDUCE-IT trial read out and when we subsequently secured the cardiovascular risk reduction indication. The reception of this remarkable data by the scientific community and the potential to positively impact millions of patients with the SEPA generated incredible demand. Prescriptions increased significantly and product revenue rose substantially. We witnessed a greater than 50% increase in the number of prescribers resulting in more than 80% growth in new prescriptions in the first year post-publication of REDUCE-IT. This evidence of uptake and market response provides evidence that with time to promote and educate, supported by outstanding execution, providers respond favorably to the CIPA as a therapy that can benefit their patients. Second, even with many advancements in therapies and scientific data, cardiovascular disease remains the number one killer globally. causing a significant financial burden and negatively impacting patients and their families. Additionally, millions of prescriptions are written globally each year for fibrates and omega-3 mixture products for patients with cardiovascular risk, even though they're not beneficial in reducing cardiovascular risk. As a result, the reduction of cardiovascular events remains a top priority for healthcare providers, patients, caretakers, governments, and the investment community. our confidence remains steadfast that vasepa-vaskepa represents an important option in the global arsenal against cardiovascular disease and therefore a true difference maker in patients' lives. Third, unlike in the U.S. where we had time to commercialize vasepa prior to the publication of the reduced data and the cardiovascular risk reduction indication, We're in the early phases of our global expansion effort, targeting key markets around the world. To date, we've unlocked access and launched in some European markets. However, there remains significant potential to advance access to VSCEPA for many at-risk patients in a number of additional critical markets. And finally, VSCEPA has a long runway to generate revenue based on its strong IP position. particularly in Europe, where we have recently received extended patent rights into 2039. The combination of the strength and extent of clinical data, its runway, and the opportunity for sustained growth and impact, together with the ability to save lives around the world, translate into a tremendous opportunity for us to maximize ASEPA and the SCEPA's worldwide potential. Before we move on to operational performance in the second quarter, there are a few additional points I want to highlight about Ameren and how we'll operate moving forward under my leadership. We have a fantastic team, smart, committed, passionate, and I can assure you that no one here is satisfied with our commercial progress. We're always looking for ways that we can generate new ideas and improve execution. And we know we must find new ways to perform better and faster. As a significant shareholder with substantial vested interest in the company's success, I'm determined to drive value for all of us and understand my responsibility to do just that. As I lead the company to build greater value, I think and act like a shareholder every day. My focus is clear, to prioritize execution and performance while urgently evaluating opportunities to expand the impact of ASEPA to millions of patients worldwide. That's our commitment, to provide value to patients, providers, payers, and of course, shareholders. Let me now turn to some of the operational highlights from the quarter. Turning to slide six. In Europe, our teams are making progress and realizing incremental revenue growth, but we have much more work ahead of us. The seeds for recent growth were planted more than a year ago when we put a new strategy in place centered around targeting a more focused patient population, coupled with improved resource prioritization, all with a focus on enhancing the value proposition for Veskepa in the market that can deliver the greatest impact for patients. Part of the challenge we faced in Europe is the reality that compelling data, such as Reducid, many times clashes with budget realities in individual markets. A broader label creates an enormous opportunity in Europe due to the strength of the Reducid trial, which demonstrates that Veskempa can benefit millions of patients, all within the label. There are approximately 7 million patients that meet the label criteria in Europe. While this is very powerful and the scale is an enormous opportunity for us, it's also a challenge for the reimbursement authorities from a budget perspective. We need to respect that and work with the authorities to find the middle ground of helping as many patients as possible while doing so in a manner that's sensitive to the budget constraints. In 2023, we implemented a strategy to accelerate progress which focuses on a higher risk subset of reduced patients. This is intended to help us obtain favorable access and reimbursement more quickly while preserving long-term potential, as well as accelerate sales growth upon launch with a more focused, efficient commercial structure. We're seeing this strategy resonate with authorities and hope that once we establish momentum in key country providers, they'll use the product to benefit more of their at-risk patients. In the second quarter, the team continued to deliver on the strategy and made advances. Specifically, Spain's delivering robust growth following our highly successful Veskepa launch in that country last fall. The early success in Spain further confirms what we learned from our promotional and educational efforts in the U.S., that when HCPs and payers learn about the science and benefits of Veskepa, this medication can sell in Europe. Our sales team there is targeting 2,500 key HCPs, covering 80% of the total market, and augmenting our sales efforts with continued focus on a commercial and medical strategy centered on increased HCP interactions, regional congresses, and publication plans. These efforts should help to solidify the case for Vescapa in this important European market, and should serve as a model for how we expect to execute our strategy in other European markets. In the UK, we implemented significant impactful changes to accelerate growth. A refined, focused commercial strategy, coupled with organizational changes, including a new general manager and a revamped Salesforce structure. The UK team is energized, focused, and accelerating growth. They're focused on the most critical accounts and optimizing access in these accounts. We expect this positive momentum to continue and contribute to sustained incremental revenue growth as we move forward. Turning to pricing and reimbursement progress, we're focused on advancing opportunities in other key EU5 markets. In Italy, our dossier is now under review with local health authorities. We're confident that our submission will again deliver a positive clinical assessment, and we remain committed to doing all we can with the authorities to lead to a successful price negotiation by the end of the year. In France, with the recent publication of the Respect EPA Cardiovascular Outcomes Study of Eicosapenethyl, we have key additional data available which will strengthen our clinical dossier. In other European markets, We recently secured national pricing and reimbursement in Greece and Portugal, and we look forward to realizing additional revenue contributions from these markets. As we look to the future, the European market represents an important long-term source of growth for Vizgepa. With IP protection in Europe out to 2039, we stand to realize tremendous value and impact millions of patients for years to come. Moving to slide seven is the rest of the world. Overall, the rest of the world represents a number of countries that together provide a sizable market expansion opportunity. Along with our partners, we continue to make regulatory market access and commercial launch progress across key markets, all of which further expands access for patients to Vesepa and Veskepa, reinforces the impact the product has already achieved and enhances cash generation for the future. Specifically, looking at Asia, in China, our partner, Edding Farm, recently announced that they received regulatory approval from ASEPA for cardiovascular risk reduction from China's National Medical Products Administration, or NMPA. Following approval by NMPA, Edding is working to include ASEPA on the National Reimbursement Drug List, or NRDL, and augment the ongoing commercial launch of the CEPA in China to include the cardiovascular risk reduction indication. NRDL listing serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population. Products included in this listing can be readily prescribed from public hospitals in China. This is an important step in advancing access for Vesepa to patients across China and to making it a key component in the treatment paradigm addressing the growing CBD public health issue in the second most populated country in the world. To that point, according to the World Heart Federation, cardiovascular events such as ischemic heart disease and stroke had been projected to increase by 50% among the population in China between 2010 and 2030. As a reminder, our agreement states that as a result of achieving the cardiovascular risk reduction indication in China, Ameren earned a $15 million milestone payment from Edding in addition to future commercial milestone payments as well as key royalties on sales, a source of sustained cash in the years to come. In Australia, our partner, CSL Securus, has now advanced the pricing and reimbursement discussions with local authorities to the final stages. We're also supporting commercial launch readiness in the market through medical education and Salesforce readiness initiatives. In Canada, our partner HLS Therapeutics announced that it's entered into a product listing agreement with the province of Alberta for the listing and public reimbursement of Vesepa. The PLA with Alberta Health is effective August 1st, 2024. In summary, our teams and partners are continuing to advance efforts to get Vesepa and Veskepa into the hands of as many patients as possible globally. We've made progress under sometimes difficult market and reimbursement challenges, but as more stakeholders become increasingly educated on the strength of the VSIPA clinical data and what it means for patient care, our confidence continues to solidify on its long-term value. Now turning to slide eight in the U.S. In the second quarter, the U.S. team continued to maintain our IPE market leadership through exclusive accounts representing approximately 50% of the IPE market. Prescription market share remained stable in the U.S. for the seventh consecutive quarter. While revenues in the quarter were impacted primarily by a decline in net selling price due to generic competition, the U.S. business continues to generate cash, funding our efforts globally, particularly in Europe. Our market share strength is a direct result of what the U.S. team has done to work efficiently while maximizing the SEPA's value in the U.S. despite last year's strategic decision to eliminate the sales force and significantly reduce marketing spend given increasing generic competition. While we're encouraged that the prescription volume has remained stable in the first half of 2024, as we've always said, the U.S. market is highly dynamic. We announced during the second quarter that in the second half of 2024, our business will be impacted by the loss of an important contract with a major exclusive commercial account, which moved branded Vesepa to a blocked status on its formulary. This account represents approximately 25% of our business and is expected to reduce our second half 2024 revenues. It is important to keep in mind that, while the decision will undoubtedly have a significant impact on overall Vesepa volume, We believe that branded Vesipa will continue to be the market leader in the total IPE market even after taking into account the full impact of the loss of this major exclusive plan is absorbed. And importantly, despite the ongoing challenges presented by generic competition in the U.S., remember we've prepared for all scenarios and are ready to change our approach to this business as the market continues to evolve. This includes the launch of an authorized generic at the optimal time, which would be bolstered by our strong supply position. We believe this would help us retain our IPE market leadership, as well as generate revenue for years to come. Now, I'd like to hand the call over to Tom Riley to review our second quarter 2024 financial performance.