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spk09: Welcome to Ameren Corporation's conference call to discuss its third quarter 2023 financial results and business updates. I would now like to turn the conference call over to Jordan Zwick, Senior Vice President, Business Development and Investor Relations at Ameren.
spk04: 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 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, We see the risk factors section of our annual report on Form 10-K for the year ended December 31, 2022, and our quarterly report on Form 10-Q for the quarter ended September 30, 2023, 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 Ameren's website in the Investor Relations section. Turning to today's agenda, Patrick Holt, Ameren's President and Chief Executive Officer, will lead our discussion, and Tom Riley, Ameren's Chief Financial Officer, will provide a detailed review of our third quarter 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.
spk05: Pat. Thank you, Jordan. Good morning, and thank you, everyone, for joining us today. During my three months with Ameren, I've been focused on ways to drive shareholder value. What I have learned is clear. First, we have a company and a product in Vesipa Vescafa with significant global potential. backed by tremendous scientific data, including a 25% relative risk reduction on top of statin, and is therefore a medicine that can have profound impact on cardiovascular patients globally. In addition, the company has a strong balance sheet with $321 million in cash, delivering five quarters of cash flow positive results and no debt, I also know that delivering and showing results is what will drive shareholder value at Ameren. Whether it's commercial, market access, operational, or R&D, what matters moving forward is that we demonstrate results. As we look to our path forward, it's important to acknowledge the meaningful and important results we are delivering. Following the third quarter, we have now reported five consecutive quarters of positive cash flow. This has been achieved through tough but net decisions to reduce headcount and operational expense, as well as ongoing discussions with supply partners to renegotiate supply agreements. Today, we have $320 million in cash on hand, an increase of $15 million versus Q3 2022 and no debt. whilst our European business has not delivered what we have expected to date. And we know we need to do more. We are encouraged by the focus and impact of our new leadership and team is demonstrating and by early progress from initial launches in key countries. Fundamentally, we are confident in our European opportunity given our IP position with the potential to have protection up to 2039. We will discuss this in more detail later in the call. November marks three years since the first generic entrance in the US. Despite this challenge, our team has extended the lifecycle and market leadership of ASEPA, maintaining 57% market share. The durability of this business has been extended by sustained investments in managed care and trade capabilities, despite the elimination of the US sales force. In the rest of the world, overall, we are at early stages of expansion via partnerships. Whilst we have revenue from partners in Canada and the Middle East, we have tremendous opportunity in key markets such as China, as well as Australia and New Zealand. Notably, China launched the very high triglyceride indication in September and submitted its filing for cardiovascular risk reduction last week. Recently, we discussed the progress to date and path forward with our board of directors. In those discussions, it was clear that the best path forward for Ameren today is to remain focused on accelerating operational momentum. In Europe, our teams will continue to be focusing on key launches, including the UK, Netherlands, and Spain, while also continuing to advance pricing and reimbursement efforts in a number of markets, particularly Italy, France, and Germany. In the US, we'll continue to support our business through targeted efforts, including managed care and trade initiatives to secure exclusive contracts. And in the rest of the world, we'll continue to support our partners to get our product into the hands of as many patients as possible. We believe this focus on operational momentum will maximize shareholder value and position us for future strategic options. Moving to Europe, our teams continue to work to deliver both pricing and reimbursement as well as commercial progress in a region which is challenging for the entire industry. From a commercial perspective, whilst it remains early in the commercial launch process in key countries, we are beginning to see initial signs that our local country strategies are working. In the United Kingdom, first, it's important to note that this is traditionally a slower uptake market. This is driven by a number of factors, but mainly the complex healthcare system in the market. Whilst the team faces that challenge, they have successfully unlocked all formularies within the first few months post-launch in England and Wales. We now have a more focused strategy in place, including driving uptake in key accounts that is delivering now more than 30% quarter-over-quarter pharmacy sales growth. In Scotland, following recent reimbursement approval, the team is progressing access to formularies. In Spain, our commercial team is focused on HCPs who are early adopters of cardiovascular products, and we are seeing promising yet early sales across all regions, We now estimate 500 patients are on therapy one month post-launch. And in the Netherlands, our team is executing on a focus strategy based on identified key accounts to drive adoption. This is backed by extensive local market research. We now estimate more than 100 patients are on therapy one month post-launch. On the pricing and reimbursement front, we have now secured pricing and reimbursement across nine countries in Europe, including Spain, the Netherlands, and Scotland in the third quarter. This continued pricing and reimbursement progress strengthens the foundations for VASCEPA in additional markets where we are seeking pricing and reimbursement decisions. In Italy, Ameren has finalized a new path forward to pursue market access for VASCEPA by the end of 2024. In France, we are progressing a new access strategy for Vesca with the national authorities. We do not expect this process to conclude in 2024. And in Germany, we are continuing to evaluate potential options to secure pricing reimbursement for German patients. We will share more on Germany in the coming quarters. In terms of other markets where we have ongoing pricing and reimbursement processes underway, we do not expect to receive additional decisions in 2023. We remain confident in our path forward in Europe, particularly given our intellectual property in the region. We have regulatory data protection in Europe until and we also have patents and applications that have the potential to extend our IP well into the decade, indeed potentially up to 2039. Turning to our US business, November marks three years since the launch of the first generic IP into the market. As we all know, most generic markets quickly erode the brand in the United States. As we sit here today, Branded BESIPA continues to hold market leadership with 57% market share and 43% of all Part D lives covered in the US. This market leadership and the work done by a US team to extend the lifecycle of the product has continued to deliver the revenues needed to sustain our business and bolster our financial position. In the third quarter, we had net product revenue of $62.4 million, which is stable versus the second quarter of 2023. We have achieved this by being very efficient with our U.S. operations, sustaining our investments in managed care and trade efforts to support our exclusive contracts, which continue to represent approximately 75% of the U.S. business. Our focus in the U.S. is on continuing to maintain and extend the lifecycle of the Vespa branded business. With that said, aligned to our strong supply position, and as we have stated previously, we stand ready to execute different aggressive scenarios, including the potential future launch of an authorized generic in order to retain market leadership of the IP market. These scenarios are centered around preserving our profitability and of course, our cash. Turning to the rest of world, our approach is focused and clear, that is to expand via partnerships to bring the unique value of our product to maximize the number of patients globally on therapy. We have continued to make progress in our strategy by supporting the efforts of existing partners to deliver market access and by securing agreements with new partners. Beyond partnered markets, we are in the second year of a three-year plan to submit and obtain regulatory approval in 20 or more additional countries and regions to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from our product. From a commercial perspective, our partners are continuing to make significant, yet early progress as well. In China, the second largest cardiovascular market globally, Amarin's partner, Edding Farm, launched the Cepha in October for the very high triglyceride indication. Edding has also submitted its regulatory filing for a potential indication for cardiovascular risk reduction. It's important to note that this filing has been submitted with a clinical waiver, meaning that an additional regulatory study will not be required to review the new indication. The company is now awaiting the agency's acceptance of that filing. From a partnering perspective, in the third quarter, we signed an exclusive agreement with Lotus Pharmaceuticals to commercialize VASCEPA across 10 countries in Southeast Asia and South Korea. We also signed an exclusive commercialization agreement with Nirofarm for VASCEPA in Israel. In each of these markets, as well as Australia and New Zealand with our partner CSL, Seqirus, regulatory market access and pre-launch activities are well underway. In summary, we are making progress in our efforts to get our product in the hands of as many patients as possible around the world. Our team is doing this with a core focus on operational momentum and with a tremendous sense of urgency to accelerate that progress. We believe this is what will create shareholder value. We are listening to and we appreciate the input from our important retail and institutional shareholders. Now, I'd like to hand the call over to Tom Riley to review our third quarter 2023 financial performance. Tom?
spk08: Thank you, Pat. Good morning, everyone. I am pleased to report details on our financial performance for the third quarter of 2023. Let me begin by discussing our revenue performance. In the third quarter of 2023, Ameren reported total net revenue of $66.1 million. including net product revenue of $64.9 million versus $65.2 million in the second quarter of 2023, and $1.2 million in licensing and royalty revenue. U.S. product revenue was $62.4 million, which includes a $6.5 million one-time adjustment primarily due to Medicaid rebates. This is a decline of 2.2 million versus the second quarter of 2023, reflecting lower net pricing in the U.S. We remain pleased with the stable performance in the U.S. despite multiple competing generics on the market. The U.S. business continues to provide profit, supporting our expansion into Europe. The revenue results include European product revenue of $800,000 compared to $600,000 in the second quarter of 2023, reflecting early revenues from European markets, including the UK, Spain, and the Netherlands. We recognized $1.2 million in license and royalty revenue in the third quarter of 2023, including from FASIPA-related commercial sales from our partners in Canada, China, and the Middle East, as well as an upfront licensing fee from our partner in South Korea and Asia. Cost of goods sold for the three months ended September 30, 2023, was $36.2 million, which includes a $12.7 million of inventory settlement charges. Gross margin on net product revenue was 64% for the three months ended September 30th, 2023, when you exclude the impact of supply settlements in the quarter. Moving on to operating expenses. During the third quarter of 2023, excluding restructuring expenses, operating expenses were $50.5 million versus $64.5 million in the same period of 2022. Selling, general and administrative expenses in the third quarter of 2023 were $45.5 million compared to $58.7 million in the corresponding period of the prior year. The decrease was primarily due to the implementation of our July 2023 announced cost reduction plan, as well as other cost savings initiatives throughout the year. Research and development expenses in the third quarter, 2023, were $5.1 million, from $5.8 million in the corresponding prior year period, with the decrease being driven by the implementation of our previously announced cost reduction plan. Under U.S. GAAP, Ameren reported net loss of $19.3 million for the third quarter, or basic and diluted loss per share of five cents. Let me now turn our efforts and results in controlling costs and effectively managing our cash. As of September 30, 2023, Ameren reported aggregate cash and investments of $321 million, delivering a cash-positive quarter of $8 million. Importantly, this is the fifth consecutive quarter of positive cash flow generation for Ameren, and our cash balance is now $15 million higher when compared to the third quarter of 2022. We have continued to make progress against our cost reduction program in managing our cash position. We are on track to deliver $40 million of annualized savings from the reduction in force announced in July of 2023. We will continue to focus on cash preservation, find additional ways to reduce costs, and prudently invest in the right opportunities which are value-added. We have also continued to take steps to strengthen and streamline the company operationally, including making strides in renegotiating supply agreements to lower our future commitments. With these initiatives and the relatively stable trends in the U.S., we believe our current available cash and resources including the U.S. profitability, are adequate to support continued operations, including European launch activities. In closing, we will remain focused and vigilant in controlling costs and effectively managing our cash position. With that, I will now turn the call back over to Pat for closing remarks.
spk05: Pat? Thank you, Tom, for the financial overview of our results during the third quarter. As we look forward to the remainder of 2023 and into 2024, our team is focused on operational momentum to maximize shareholder value. That focus cuts across all three of our regions, Europe, the US, and rest of the world. We firmly believe this focus on operational momentum is the best path forward for AMRA and will more strongly position us for future strategic options. Controlling costs and preserving cash are essential. With that said, we can only enhance the value of Ameren and therefore deliver shareholder value by delivering results in our three core areas. Focused investments in Europe to accelerate prescription growth and revenues, as well as securing pricing and reimbursement in key markets supported by a runway out to potentially 2039. for SEPA branded revenue and profits in the US and enabling our partners to get our product into the hands of as many patients as possible around the world. Before I close, I'd like to make a comment about an important topic on all of our minds, our current stock price and performance. Like all of our shareholders, none of us are satisfied with the company's stock performance. We fundamentally do not believe our current valuation reflects true value of Ameren. all the opportunities that lie ahead for the company and for CEPA, for SCEPA. The company has a strong future because of our fundamentals that reinforce its value. Our best in class science with a global opportunity and impact for cardiovascular patients, our team that is dedicated and delivering results and our strong balance sheet. That is why we believe in Ameren and we fundamentally believe the stock performance is disconnected from these facts. We believe we have the right plan focused on operational momentum to drive shareholder value. Finally, I would like to thank our colleagues for their unwavering commitment and dedication. I look forward to delivering results and driving shareholder value together. And with that, Jordan, let's please begin the Q&A portion of today's call.
spk04: Thank you, Pat. As we announced earlier in October, to enhance engagement with the company's shareholder base and facilitate connections with its investors, Ameren is partnering with SAVE Technologies to allow retail and institutional shareholders to submit and upvote questions, a selection of which will be answered by Ameren management during today's earnings call. We will begin today's Q&A by addressing select questions on the SAVE platform. Our first question is regarding the fixed dose combination and any update the company can provide on that program.
spk05: Thanks very much for the question. And naturally, innovation is really important to the company. Look, whilst we're unable to disclose specific details on the program, at this point, evaluating our priorities against resources, it's become clear that the fixed-dose combination is not a priority that will drive near-term value for the company. Therefore, the program is being deprioritized. Our very important R&D group continues to focus on global regulatory support, market access, as well as scientific publication strategy to support our product globally.
spk04: Thank you, Pat. Our second question is on M&A. Are there any plans of selling the company to someone who can get the SEPA, the SCEPA, effectively launched into the market?
spk05: Yeah, thanks very much for this question also. Naturally, I received this question quite a lot since I've joined the company. Look, management and the board, naturally, you know, we're really committed and we're very focused on the fact that our company today is significantly undervalued. And we're therefore collectively focused on maximizing shareholder value. We're focused on the operational momentum that we can deliver and the value that can create for the company and therefore for shareholders. This is the best path forward for us at this time, and as a result, strengthens our position for future strategic options.
spk04: Our third question is on the stock price and potential delisting from NASDAQ. Can you comment on this?
spk05: Look, it's top of mind for all of us. It's a very important topic. Look, given that we've been trading under $1 for 30 consecutive trading days, we have received official notice of a potential delisting from NASDAQ. It's important to note that that full process could take up to 360 days if we trade below a dollar. And there are a number of opportunities for us to regain compliance to NASDAQ rules. I mean, to state the obvious, our public listing is really important to investors, to the whole management team and to our employees. And the most important thing I want to share with you is that fundamentally we're focused on enhancing operational momentum alongside our cash preservation approach that we believe will drive the stock price forward. We're confident that we can achieve this. Before we take additional questions, I'd like to thank those shareholders who submitted questions via the Say Technologies platform this quarter. We are committed to continuing open and transparent dialogue with 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 our shareholders and answering questions on this platform moving forward.
spk04: Thank you, Pat. We will now open the Q&A up for additional questions.
spk09: 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. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start keys. One moment, please, while we poll for questions. Your first question is coming from Louise Chen at Cantor.
spk10: Hi, thanks for taking my question, Sarah. I wanted to ask you if your 2023 OPEX guidance still holds Because it seems like your cost reduction was greater than we would anticipate it in the third quarter. So just curious, you know, how to think about fourth quarter. We still kind of plug into that guidance. And then what would trigger you to launch an authorized generic? And the last question is, when do you think we'll see a pickup in EU sales? Thank you.
spk05: Thanks, Louise. Thanks very much for your question. So possibly I can take the EU question first, and then Tom, if you want to take the lead on the OPEX and the AG question, if that works. So thanks again for your question. So in terms of the EU, as I mentioned, it's early days. We're pleased with some progress, particularly given the new leadership we have in place in the teams in Europe, as I mentioned, encouraging to say that we're unlocking broke in the UK with 30% quarter-on-quarter pharmacy sales. In Spain, one month into the launch, 500 active patients on therapy. And in Netherlands, with a really focused strategy, with the top 30 accounts that represent about 55% of prescriptions, that's around 100 patients so far. But as you understand, Louise, it's early days. So the way we're thinking about when we'll start to see really meaningful revenue in Europe, we think about it being toward the end of 2024. That's really where we're tracking toward. Each market is different, as you well understand, and we're focused on really launching very successfully in those key markets in the UK, Spain, and Netherlands, and continuing to advance reimbursement in those key other markets, such as Italy, that we're focused on concluding by 2024, as well as France and Germany over time. Tom, would you like to address the other questions?
spk08: Sure. Thanks for the question, Luis. Related to OPEX, and guidance for the year. So, as you pointed out earlier, we did announce restructuring in Q2 of 2023. Our OpEx runway for the first half of the year was approximately $60 million, and this quarter we reported $51 million. So, we were able to achieve approximately $7 million of our OpEx of the $40 million we said we were going to get on an annual basis. And simply that's because the announcement really kicked in or the operating expenses really kicked in beginning in August. So expectations for the remainder of the year is that our OPEX would stay in the range of for in Q4 of where we are currently as in Q3. And then as we mentioned earlier, for 2024, we haven't given any specific guidance, but we do expect cash preservation, focus on right opportunities in Europe if they avail, but keeping the operation expenses overall pretty stable. Okay. And then related to your question on the authorized generic and the opportunity there, as you'll see that we reported branded prescription sales in the quarter, our market share was 57%. So we're maintaining really good market share, still the market leader. We'll see how the market dynamics play out. We are prepared to run an authorized generic if needed. But at this point in time, given our performance on the branded side, and given overall our net sales in the US, we don't see that at this point in time.
spk06: Thank you very much.
spk09: Your next question for today is coming from Michael Yee at Jefferies.
spk03: Hi, this is on the Michael Yee. Thanks for taking my question. I guess I have two questions. First of all, on U.S., I guess how secure are the contracts that you mentioned are exclusive and how much are they, I guess how much of them are subject to contract renewal in 2024 or 2025? I guess second, on the EU side, maybe a follow-up to Louis' question as well, it seems like You know, there are, you have added less than 100 patients on treatment in the UK over the last quarter, you know, based on our calculation. How would you characterize the growth in the UK, and then what would it take to drive the uptake in that region? Thanks.
spk07: Thanks very much for your question.
spk05: Really appreciate that. So, firstly, to the question around exclusives, typically they are annual contracts. And it's really in January that we have absolute clarity on those contracts being renewed. Right now, they represent about 75% of our business, and that's continued to be stable for a significant period of time. As we sit here in October, we're feeling that we have good progress as we're entering 2024, feeling very comfortable. We certainly have seen some signals around this time of the year that really give us confidence as we're entering 2024. With that said, we get absolute line of sight on our exclusive contracts in January. But that's been a really stable and important part of the business that continues to be the Uber focus of the U.S. focus as we continue to invest in trade and managed capabilities.
spk07: To the U.K. question.
spk05: I think it possibly, you may have misheard me, I think it's a thousand patients that we have so far on therapy in the UK that we estimate. And as I mentioned, we've demonstrated 30% quarter over quarter pharmacy sales, which let's be honest, it's still not what we need to be in the UK. But I think as a result, the leadership changes that we've seen, and we're starting to see some focus
spk06: with really a focus on key accounts. Okay, thanks.
spk09: Your next question is coming from Rowana Ruiz at Lyrinc.
spk02: Hey, morning, everyone. So on the Medicaid rebate adjustment of about $6.5 million, I was curious, could that occur in future quarters to the same degree? And what's driving that adjustment? And second question is, regarding your amended supplier agreements, how close are you to completing this process? And could you just explain why amending these agreements had a bit of a higher charge this year relative to last year?
spk08: Sure, Rowana. It's Tom. I can take both those questions. So the first question relates to the Medicaid adjustment component. So in the quarter, correct, we did recognize the $6.5 million one-time Medicaid adjustment. So it is one-time. We don't expect that moving forward. The reason for the adjustment is we provided an estimate of how many patients were coming through the Medicaid channel as revenue. and actually the patients were lower. So this quarter we did recognize that drill, but it is a one-time component. So the second question, Ron, related to supply agreements and line of sight on the supply agreements. I think overall the position here is we have a really good relationship with our suppliers, and we're making progress in balancing our supply commitments with future demands that we need. So overall, it's hard to determine when we expect these restructuring charges to end. We're balancing our commitments with the suppliers versus the commercial sales pickup. And it is complicated because as part of our supply negotiations, we need to make supply purchases in order to ensure we have future supply to meet the potential demand for the EU and outside of the US. So overall, we're making good progress. We're balancing it with the suppliers, but we really need to see EU sales to pick up to see when the overall charges will stop.
spk06: Okay, got it. Thanks.
spk09: Your next question is coming from Paul Choi with Goldman Sachs.
spk01: Hi, this is Khalil calling in for Paul. Thanks for taking our questions. I suppose I'll ask a question about XQS. So thanks for giving the color on the Netherlands and the Spain launches. I was wondering where those were good proxies for what you expect to see in China or whether your recent launches in Kuwait and Saudi Arabia would be a more easy lateral for that.
spk05: Yeah, thanks very much for your question. Look, it's important to note, you know, We're really trying to be much more transparent in what we're sharing with you all. It's feedback we've received from investors, so we take that on board. In regards to the different markets, each market in Europe is quite different, and then China is different again. We're in a unique position now as we launch that we are able to see that we have the patient numbers so far in Spain and Netherlands being what we have described. When we think of China, it's quite a different beast. So it's the second largest market globally. It's a very significant opportunity for us. It's actually unique also in the sense that they're launching now with a very high triglyceride indication. As I mentioned, they've just submitted for the cardiovascular risk reduction indication with a clinical trial waiver, which is very important also. That opens up the potential for national drug and reimbursement listing in the future for for the cardiovascular risk reduction indication. So we feel that China is a very significant opportunity over time. So China is really I would say China is a unique opportunity in regards to the Middle East. Those markets are the ones you mentioned are still in early stages of development. We're going through market access and pre-launch. And if we think of rest of world, And what's quite interesting and what is quite exciting for us is we have revenues right now in markets such as Canada, some parts of the Middle East, and as we just mentioned, with a very high triglyceride indication in China just from the very end of September. So we have a lot of runway for many of the rest of the world markets to continue to launch over time. Many are still in the regulatory market access. and pre-launch stages. So there's a lot of opportunity for us over time to grow the business via partnerships.
spk01: Okay, thank you. And then a quick follow-up on China. Can you offer any more color on a potential milestone payment from Edding, assuming an MPA approval for the risk reduction in CV?
spk05: Yeah, I would just say that our agreement with Edding is a typical licensing agreement, so there are payments associated with different milestones, both revenue as well as specific milestones on regulatory elements, and we have stated some of that in our filings.
spk08: Yeah, and just in more specific, we have, just to add to that, we have up to a range of $5 million to $50 million in total or $50 million in total of sales milestones that could be earned.
spk06: Okay. Thank you.
spk09: We have reached the end of the question and answer session, and I will now turn the call over to Patrick Holt for closing remarks.
spk05: Well, thank you, everyone, for your attendance today. And we really appreciate your questions, your engagement with the company. As you've heard from us, we are incredibly focused on driving operational momentum that we truly believe will therefore drive and maximize shareholder value. We appreciate your engagement and we look forward to talking to you more as the quarter continues. And please reach out to us with any questions you have.
spk07: And thank you again for your attendance.
spk09: This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.
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