Amarin Corporation plc

Welcome to Ameren Corporation's conference call to discuss its third quarter and nine month 2021 financial results and operational updates. This conference call is being recorded today, November 3rd, 2021. I would like to turn the conference call over to Michael Kolb, Chief Financial Officer at Ameren.

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 by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, these statements are based on information available to us today, November 3rd, 2021. We may not actually 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 factors that could cause actual results to differ materially, Please see the risk factors section of our quarterly report on Form 10-Q for the quarter ended September 30, 2021, and our annual report on Form 10-K for the year ended December 31, 2020, which have been filed with the SEC and are available through the investor relations section of our website at www.amroncorp.com. We encourage everyone to read these documents. This call is intended for investors in Amron and is not intended to promote the use of a SIPA. An archive of this call will be posted on Ameren's website in the investor relations section. Karine McHale, Ameren's president and chief executive officer, will lead our discussion and I will provide a more detailed review of our financial results. After prepared remarks, we will open the call to your questions. I remind you that multiple audiences typically listen to calls of this nature, including existing investors, potential new investors, employees, current and potential collaborators, and current and potential competitors. As always in this call, we will attempt to provide constructive information without compromising our competitive and strategic positioning. I now turn the call over to Karim Mikhael for a view of the business.

Good morning and thank you all for joining us this morning. The third quarter of 2021 was a critical quarter for Ameren as we continue to make important strides toward our goal to bring the SEPA, the SCEPA and its CV risk reduction benefits to at-risk patients around the world. These advances were led by the meaningful progress we made commercializing Vaskepta in Europe, as highlighted by our successful product launch in Germany in mid-September. This was followed by the announcement of our transformative go-to-market strategy in the US, which underscores our commitment to the US market, and it's designed to enhance awareness and drive demand for branded vasepa and the cardiovascular risk reduction indication. Last quarter, when I had just taken over the CEO position, I shared with you the vision for our three-dimensional growth strategy, breadth, geographic expansion, height, representing diversification, and depth or operational evolution. Today, I'm happy to report on the progress we've made executing the strategy. including a number of milestone achievements demonstrating that we are well on our way to become the global cardiometabolic commercial player we envision. Let me begin with a brief review of our results for the third quarter. Starting with our revenue, as you saw in our press release this morning, we reported net total revenue for the third quarter of 2021 of $142 million compared with 156.5 million dollars in the same period in 2020. We reported net total revenue year-to-date of 438.7 million dollars compared with 446.8 million dollars for the first nine months of 2020. The bulk of this revenue is from U.S. product sales of Vesipa. Importantly, and as Mike will discuss later in the call, our U.S. Vesipa franchise remains profitable and along with our strong balance sheet continues to support our growth and expansion plans. Now for a deeper dive into the U.S. market. This has been a particularly challenging quarter as a number of market and competitive dynamics impeded the potential for growth in the U.S. First, the impact of the resurgent COVID-19 Delta variant caused patient visits and lab visits to drop by 6% and 7%, respectively, compared with the prior quarter. Additionally, the lipid market flattened for the first eight weeks of the quarter. Finally, and for the first time, there were two generics available on the market for an entire quarter. These dynamics created both the need and the opportunity to reevaluate our strategy. So let me walk you through our thinking. We needed to better understand the key gating factors to building more significant adoption of the SEPA for its cardiovascular risk reduction indication and to develop a plan to tackle them. Perhaps the biggest rival for growth is improving physician access and engagement. Long before the COVID-19 pandemic hit, access to physicians was on the decline. For example, according to ZS Access Monitor, access to physicians in 2007 was approximately 80 percent or four out of five by the end of 2019 that access had fallen to about 50 percent during the early days of the quarantine in 2020 those levels were at mere seven percent and they currently stand at only 29 percent in other words less than one out of three physicians on average is accessible for visits by the field force our new strategy employs a digital omni-channel approach to enhancing our reach to healthcare professionals allowing us to target a far greater number of the almost 700 000 statin prescribers through high frequency customized and impactful messaging regarding the significant benefits of the SEPA for cv risk reduction simply This creates a model of engagement with prescribers in the ways they want. We intend to significantly increase the use of these robust digital platforms and integrate them with in-person visits by our sales force to enhance our reach and customer engagement and improve efficiencies optimizing our educational and promotional efforts to drive healthcare provider and patient use of branded vesipa in the US. These digital platforms include a variety of offerings such as virtual detailing, email campaigns, websites and medical portals, digital CMEs, social media, and more. Our next area of focus is managed care. While several large commercial and Medicare Part D payers currently cover the SEPA as the exclusive icosapent ethyl product, We are intensifying efforts to remove remaining barriers to the SIPA prescription to improve access to patients with real medical need. We are confident in our ability to drive further volume growth by continuing to focus on enhancing payer access. Finally, our last equally important area of focus is to clarify the difference in approved indications between the SIPA and the generics. Generics are not FDA approved for cardiovascular risk reduction. We are taking a variety of steps to eliminate confusion created by the limited indication of the generics and educate the market regarding the substitution of the SEPA with generics for non-indicated uses, particularly at the pharmacy level. Our goal is to continue to correct factual inaccuracies within the total prescribing ecosystem. from the references compendia to retail pharmacy systems to e-prescribing platforms used by physicians in order to reduce substitution for non-indicated uses and minimize any disruption in patient care. Correcting these systems is a complex process and it will take some time, but we are making progress and we expect that we can make a significant difference in keeping genetics usage within their narrow approved label. for all the above. At the end of September, we announced what we believe will be our transformative go-to-market strategy, which underscores our commitment to the U.S. market and addresses three key areas for improvement, expanding physician engagement and access, enhancing managed care access, and optimizing the SEPA prescription for CV risk reduction. Our goal is to deliver a simple, streamlined platform to manage end-to-end slow prescription and to ensure an optimized patient and prescriber user experience. While these new go-to-market initiatives are in the early days, we will be driving their implementation with a focused sense of purpose while tracking and re-evaluating our decisions. We have three measurements for success. Execution, did we successfully and urgently implement these initiatives? strategic impact, did they deliver their expected impact, revenue, and ultimately did these initiatives produce greater patient and provider usage resulting in prescription and revenue increases. We are confident that this new go-to-market strategy will be successful by all measurements and look forward to reporting more on this front as it unfolds. We also continue to consider and entertain numerous strategic initiatives which, if feasible and successful, could allow us to further differentiate versus the generics. While in early stages, we believe that such efforts aimed at truly differentiating ourselves versus generics would have a significant impact on the future potential of the SEPA in the US. Turning now to our progress in Europe. During the third quarter, Ameren demonstrated its commitment to becoming a global commercial player with its launch of VSCEPA in Germany. As a reminder, when Ameren announced in August 2020 that it would self-launch in Europe, we had no legal entities in Europe beyond Ireland, no infrastructure and no commercial presence. We did not even have a regulatory approval for VSCEPA. Today, just a little over one year since that announcement, We have an EMA approved label that is totally consistent with the broad patient population of Reducit. We have 15 legal entities and branches, including a commercial hub in Zug, Switzerland, 300 employees, and have executed our initial commercial launch in Germany. We are especially pleased that our teams were able to launch in Germany on such an expedited schedule. The launch debited with a successful scientific conference that was led by 11 internationally renowned cardiovascular specialists and was attended in person by more than 200 healthcare professionals from Germany with a live stream to many more physicians across the continent. The medical and commercial teams have made great strides introducing the cardioprotective benefits of Vescapa to the German market with 60 events hosted to date and more than 50 events approved and ready to execute before year end. This is a very proactive plan and our team is making every effort to reach our target audience both physically and virtually as access to physicians and hospitals in Germany is still limited due to COVID. In these early days and for the next couple of quarters, we believe the best proxy for a successful launch will be illustrated by the scientific endorsement from the key thought leaders and top societies and our ability to engage, educate and promote the SCIPA to our targeted audience. We are pleased to report that the SCIPA has been included in Germany's electronic prescribing system, which is updated quarterly effective October 1st. This is an important step in making the SCIPA more readily accessible as paper prescriptions represent a very small portion of total prescriptions today. We were honored to be one of three finalists for the Gallinus von Pergamon Prize or Prix Gallien in Germany, a prestigious scientific prize awarded for a particularly innovative medicinal product that has been approved in Germany at the time of submission. This year's prize went to Biontech Pfizer for their COVID-19 vaccine. So we are truly honored to have achieved the second place and we have been widely recognized for this achievement in the German press. Now on a European regional level, we previously communicated that our goal is to file 10 market access dossier by year end and I'm proud to report that we have already submitted all 10. This really allows Ameren to initiate the negotiation process with the reimbursement agencies of the largest 10 markets in Europe. Those markets are Germany, UK, Italy, France, Spain, Denmark, Sweden, Finland, Norway and the Netherlands. We have already engaged extensively with several of these countries and in our next earnings call we will provide an update on our exchanges and expected timelines for reimbursement approvals. I can also confirm that all 10 submissions included data demonstrating the uniqueness of Baskepa from a scientific perspective, various country-specific demographic data to define the eligible patient population based on the label, and the same targeted list pricing of approximately 200 euros or $240 monthly. The next wave of country submissions is being initiated now and will include five additional countries in Europe. We have also initiated the first steps to identify the partner or partners we plan to collaborate with in the Central Eastern Europe countries starting with Greece. Over the past year, we have been prudent yet agile, fast and at the same time measured in how we have built investments and infrastructure in Europe. We are prioritizing and structuring our markets organizations in a focused way driven by our belief that a tremendous opportunity exists to change the treatment paradigm in preventative cardiovascular care across Europe. Beyond Germany, in the vast majority of our targeted markets, we are in the important pre-launch phase, which means that we are establishing relationships with healthcare professionals, providing education on the cardioprotective benefits of the SCIPA and negotiating market access. Our digital first strategy and the capabilities we've developed implementing it allow us to quickly navigate and access our customers differently while complementing all of our field force efforts. We recognize that not all markets are the same and our approach to each must be tailored and bespoke. The technology behind our customer engagement ecosystem allows us to have an aligned commercial model that can be easily adapted to the specificities of the individual market and enables us to successfully integrate our digital and face-to-face channels in one single cross-functional plan. We are very excited about the opportunity for Vescapa in Europe. As CBD is an increasingly common health problem that causes 3.9 million deaths per year in Europe and costs the European Union 210 billion euros every year. Our mission to rethink the treatment of residual cardiovascular risk across Europe is no small feat, but we're up for the challenge. We are committed to improving the lives of high risk cardiovascular patients across Europe by establishing a new treatment for CVD. Setting a new standard in cardioprotective care won't happen overnight. However, we have a high level of confidence that we've got the drive, the scientific evidence, the strategy, and the people to make it happen. Beyond the significant multi-billion dollar market potential in Europe, let me turn to the other international opportunities we are pursuing. Last quarter, we announced our ambition to bring the cardioprotective benefits of the SEPA, the SCEPA, to the top 50 cardiometabolic markets worldwide. We currently have access to approximately 30 of these markets and have now mapped our strategy to obtain access in the other 20. Our plan will take place in three waves. The first will begin in 2022 when we plan to submit regulatory filings and obtain product approval in up to six countries, including Australia, New Zealand and Israel. The second wave will come in 2023. when we will seek approvals in up to nine countries. The third wave follows in 2024 when we will be seeking approvals in the remaining five countries we have targeted. These filings will all be supported by long-term cardiovascular outcome data from the REDUCE-IT study and the FDA and EMA approvals of the SEPA, the SCEPA for the cardiovascular risk reduction indication. We will be specifically seeking our EMA broad-level language in all of these countries. In most of these markets, we will potentially opt for an agency-distributorship partnership. Such collaborations have the advantage of giving us control over the marketing authorization of our product and providing optionality as we grow the business globally. We believe expanding the Ameren reach to these additional 20 markets has the potential to benefit millions of patients at risk of a CV event and represents a market opportunity of around $1 billion. Moving on to other international markets where we already have partners. In China, our partner Edding continues to expect to receive approval of the CIPA in mainland China and Hong Kong near the end of 2021. With these approvals, Edding has plans to launch in these territories in 2022. As in the US and Europe, Vesipa will launch with the support of the two key Chinese cardiology societies. With the burden of CV disease in China and with two branded statins collectively selling more than $1 billion, there is both a significant medical need and a meaningful market opportunity for Vesipa in China. In August 2021, our partner in Canada, HLS Therapeutics announced a promotional agreement with Pfizer expanding promotion of Vesipa to primary care physicians in Canada. HLS existing sales force of approximately 30 field personnel and support staff will remain primarily focused on the specialist physician audience. We believe this new agreement should bode well for Vesipa in Canada as the primary care physician market is a good gateway to patients at risk for CVD and the Pfizer name is well respected and known for excellence in the pharmaceutical industry. Finally, let me share some perspective on our thoughts around diversification, the high dimension. We continue our systematic review of all potential assets in the cardio metabolic and obesity space. We are not limiting ourselves to those that lend themselves to primary care and large populations alone. We're also considering unique assets including in the specialty and rare diseases spaces where there remains tremendous unmet need. We are prioritizing two types of assets, assets with near-term commercial potential and development stage assets that have the potential of significantly enhancing and transforming our portfolio. As you can appreciate and due to our primary focus on the cardiometabolic space, This process requires time in scientific, commercial, and financial diligence. We are dedicating the needed resources and continue to believe that this is an important leverage for future growth. With this overview of our business, let me turn the call over to Mike Cobb, our CFO, for a more detailed discussion of our financials. Mike?

Thanks, Karim. During the third quarter of 2021, we reported net total revenue of $142 million, a decrease of 9% compared to the third quarter of 2020 and $438.7 million for the nine months of 2021, a decrease of 2% over the same period of 2020. During the third quarter of 2021, we reported net product revenue of $141.4 million, a decrease of 9% compared to the third quarter of 2020, which was largely driven by decreased US VSIPA sales as a result of the impact of generic products for VSIPA's initial indication and the ongoing impact of the COVID-19 pandemic. For the first nine months of 2021, we achieved $436.6 million, a decrease of 1% over the same period in 2020, which was largely driven by a decrease in sales to our partner in Canada of $8.5 million which included an initial order in 2020 for the launch of a SIPA in Canada partially offset by an increase in U.S. SIPA sales of approximately $2.9 million. However, as Karim noted, despite this decrease, the U.S. business has continued to be profitable in the third quarter as a result of our continued expense management. Despite the generic competition in the U.S., we believe that the patient need for VSIPA in the U.S. is high and that our new U.S. go-to-market strategy will accelerate revenue growth in this market. The profitability of our U.S. operations continue to support the expansion into Europe and other geographies around the world. However, due to the variability of spend related to these initiatives, our overall profitability in the short term may fluctuate. Additionally, absent the one-time charge of $14.1 million related to the transformation of our go-to-market strategy for the U.S., we would have achieved net income in both the three and nine months ended September 30, 2021, which further shows that we have positioned ourselves for growth both in the U.S. and throughout Europe. Additionally, we continue to monitor the ongoing global supply chain issues, which are resulting in inventory supply shortages for numerous companies and products. While we are not currently impacted by these shortages, we continue to focus on maintaining adequate supply to meet the expected global demand. As of September 30, 2021, Ameren reported aggregate cash and investments of $517.9 million, consisting of cash and cash equivalents of $222.9 million, and liquid short-term and long-term investments of $256.3 million and $38.8 million, respectively. We believe our current resources and the U.S. profitability are sufficient to continue to support launching Vizcappa successfully throughout Europe and in other international countries throughout the world. With that financial overview, I will now turn the call back to Karim for closing remarks. Karim?

Thanks, Mike, for the financial overview. Now that we have shared our roadmap for the future, our goal is to keep our eyes on the road ahead as we execute our strategy to reinvigorate growth in the US, successfully launch Basquepa in multiple countries in Europe, and obtain regulatory approvals in a number of new countries in 2022. We believe the realization of these ambitions for Ameren will be our collective success, as I'm confident that achieving these goals will build value for the company and enhance shareholder value over time. With that, Operator, we're ready to open the call for questions.

Thank you. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. And the first question is coming from Yasmeen Rahimi from Piper Sandler. Yasmeen, your line is live.

Good morning team. Thank you so much for sharing all the updates and congratulations on filing in the 10 dossiers ahead of schedule. Kareem, I would love to understand a little bit more the cadence of these 10 dossiers and how soon they would be put into place and how we should be thinking about it. So is it, could we be expecting that over the next six months all of those dossiers would potentially be granted and you could start building a market strategy in these countries? So just give us an idea of the cadence of the 10 dossiers that are in place. That would be very helpful. And then second question is, as you are now in launch in Germany, do you still continue to be confident that you would like to launch on your own or is there a change of hearts of potentially considering partnership? And thank you for taking my questions.

Thank you, Yasmin. So on the 10 dossiers, You know, it is great that we were able, speaking of cadence, to already submit the 10, right? You know, the amount of work that is required in specific analyses that those agencies require is huge. Maybe people don't imagine the magnitude, but some of these files are one gigabyte and they include up to 300 analyses of our patient population and reduces. So already the fact that we have submitted we believe is a great milestone. Now with regards to the next steps, I'm going to generalize because these are 10 countries and all of them have a very different timeline and a very different process and even attitude toward dealing with the files. You have a group of them that actually have a clock, meaning they're tied to coming back to us at a certain point in time with a preliminary reaction. Example of these countries are the Nordics. usually most of them have a clock and they have to come back to us usually in 90 to 180 days with a response some of these preliminary responses are going to be a no because that's part of their strategy and then you know we immediately answer their questions and we move to step two so this is with regards to you know those that have a clock A number of countries don't have a clock. Italy doesn't have a clock, right? France doesn't really have a clock. It can take longer, shorter time. But we are in direct engagement on a weekly basis with these agencies. We did receive from all of them all their questions, and in many, we have already responded. that's why you saw that in our earnings script just a few minutes ago we said that by next earnings call we will be able to provide detailed feedback and a timeline because by next earnings call we would have received a reaction to where is this going how long it's going to take us but we are talking about approvals of those 10 dossiers in 2022 some might come early some might come later and it will depend on the negotiation I will remind everybody that if we go and concede on the price and say oh we're willing to discount x percent we may have a faster reimbursement but I'm not sure that this is going to build shareholder value on the long term so that needs to be taken into account so that's on the 10 on the 10 dossiers cadence and what we expect over the next few months Now in terms of launch in Germany, we have already planned and invested for a self-launch in Germany. If you compare the investments we put, the size of the field force, the infrastructure we built, I think is as robust and as big as many of the key players in the biopharma. Do we answer phone calls and do we talk, you know, to partners when they give us on ongoing basis, right? And we will always challenge ourselves whether we're doing the right thing, yes or no. There is no dogma around this. This is business. You know, we're launching at this point in time in Germany, it's still, you know, pretty restricted because of COVID. we have not reached out to everybody in our target audience until today despite the fact that we've been on the market for a few months so it will take us or anybody else some time to engage in the German market that's why we're saying that the best proxy we can look at at this point in time is really the the support and the endorsement that we're getting from the societies from the scientific leaders and we believe that the ramp up will happen Slowly but surely.

Thank you, Karim.

Thank you. The next question is coming from Rowana Ruiz from SVB Lyrinc. Rowana, your line is live.

Great, thanks. Morning, everyone. A quick question on Germany. I was curious if you could elaborate on the number of physician targets you're possibly focusing on and What types of practitioners appear to be early prescribers of Veskepa? I'm specifically wondering if they're, you know, more high volume prescribers of statins. Are they more specialists or generalists, et cetera? Whatever color you can provide.

Thank you, Rowan. So, to give more granularity on the German Lodge, so we did target you know, every specialist that really is involved in the cardiometabolic and cardiovascular risk management. So basically between hospital and private cardiologists, we really cover basically 100%. In terms of GP practices, we cover the percentage that allow us to cover 80% of the business, which are in the tens of thousands at this point in time. So it's a pretty significant target audience. that's why with the restriction we actually had to prioritize because the way we segmented and targeted we used volume so the potential of these physicians as a key criteria to target but more importantly who are in the innovation business who are the ones who very readily prescribe new products that are you know not the one to do euro style and they're willing to innovate and go beyond what is traditional to support their patients. This is the lens that we use. Definitely, because of the restriction, we had to focus on our target A and B, not the C and not the D, just because for us to deliver prescriptions, you have to visit the physician at least three, four, five times. That's the bare minimum that you need to deliver to truly engage, to truly have a dialogue and you know until the product was on the market we hardly were able to get to the three maybe or some maybe four so that we saw that we communicated the number of meeting events that we're having because that's another strategy to reach out to physicians instead of saying it's one-on-one you know a speaker tour so after our launch event by the way we had a very significant effort to do a German speaker tour with a number of speakers who went from region to another because that can get those physicians who are not open to go to a physical meeting instead of driving traveling and being with for example 200 other physicians if they see that the group is 20 25 30 they are more comfortable to attend and this is what we've done when you saw that we said you know 60 meetings up to now. These are the sort of events that we execute. Going back to your question about how many are early adopters, the early adopter range is in the single digit. of the German target audience. So just also to see it in a quantitative way. But again, a lot of effort, important strides, and we believe that over the next couple of quarters we will be able to see better the picture of the uptake in terms of scripts and revenue. Thank you.

Okay, great. That's really helpful. And then maybe quick switching gears to the US. I was curious, what metrics are you, you know, internally tracking to understand how the new US go to market strategy is gaining traction? And how might that inform your your push and pulls and how you adapt your strategy in the next quarters?

Sure. Great question. So The metrics we're focusing on really are the ones that relate to what we know is critical at this stage. As you've heard, we said that we know that it is incredibly difficult to drive growth if you don't have the breadth and the depth of the engagement with the target audience. We did have a large field force, but despite that, and because of the access limitations at the physician level, we were not able to engage with them because the door was not open. so what we did was to redefine a number of territories where our reps and our sales managers can actually engage meaning they're not going to spend their day knocking on doors that are closed right so a very important metric is the level of engagement that we're able to deliver are our teams able to meet discuss and you know and and move the needle so the breadth of the reach, but also the depth, meaning how many prescriptions on average we are able to drive. Up to now, 50% of the SEPA prescription are driven by only 6,000 prescribers in the US. That's why we believe that there is an opportunity that if we expand and broaden the engagement and, you know, and even have deeper engagement that we can drive this number to be higher and the number of scripts delivered by physicians. So that's one metric relating to engagement. The second one has to do obviously with the situation with the generics because today what we are seeing is that a significant number of patients who are indicated for cardiovascular risk indication which is an indication not approved for the generic are still getting the generic. and you know there are things that we can do as Ameren about this and there are things that are out of our control let's face it if you know if the genetics continue to supply the market beyond what is needed I'm being very clear beyond what is needed because the indication size that they have is literally seven to eight percent of the market but if they continue to push more supply You know, the payers will use it and we have challenges. That's not in our control. There is a legal sort of, you know, path to deal with this. What is in our control is what are we doing to secure the fulfillment of our own prescription. So what we're really focusing on as a metric is What is the fulfillment rate? How many rejections are we getting? Are we truly getting, at the end of the day, every prescription that is written by a physician fulfilled at the pharmacist at the end of the day? And that's why we have a number of initiatives to drive this level of fulfillment to be much higher. So these are really the metrics we're focusing on. It's a difficult question, Rowana, but I hope I clarified.

Yep, that was helpful. Thanks.

Next question.

The next question is coming from Michael Yee from Jefferies. Michael, your line is live.

Hi, good morning. Thanks for the questions. Two questions, if I may, really quick. One is, if you go back, you had mentioned or prior management had mentioned there were some lawsuits initiated against pharmacies in part trying to enforce on label prescription to dispension. Can you just remind me briefly where those were, whether there was any update on the proceedings of that? I think that would be an important potential development in the future. So just remind me on that. There's any traction there. And then second question is, I thought you are slide around business development was was really interesting and you gave some pretty, pretty good specifics. Cardio metabolic obesity, especially rare diseases. And I think I'm aware of some of those products out there. Can you just comment on how urgent or how near-term these types of things could be? I think that could be quite interesting to leverage your sales force. So maybe just talk about that because I think that could be important. Thank you.

Perfect. Thank you. So on the lawsuits, let's clarify, we actually do not have any process against any pharmacy or pharmacy chain. We actually have one against, you know, a genetic supplier and a payer. specifically HealthNet. That's what we have in place. This is what we continue to pursue. There was at a certain point in time a request from the two of them to basically dismiss the case. There was a magistrate opinion to deny this request for dismissal. Then the district judge asked for an actual hearing. This took place two weeks ago or a bit more and we're expecting you know, a decision by the judge on accepting or rejecting the request for dismissal, you know, in the next few weeks. In any case, you know, if it's accepted, we would happy and we would continue to fight this. And if it's denied, we also continue with that because we believe that we have a very strong position in terms of, you know, our legal standing on this issue. So that's on the first question. Is that...

Okay, very helpful on that part. Great.

Yeah. On the second question with regards to diversification, we wanted to add more color in this earnings call, you know, to almost qualify the type of effort that we are making and what we're targeting. This was not intended in any way to somehow highlight timelines or even urgency because we get the question very regularly, what are you looking at? What are you focused on? And we wanted it to be clear that we believe we're building an incredible equity in the cardiometabolic obesity space. These are the leaders, the thought leaders, the scientific authorities that we're engaged with and today we're building credibility, we're building equity. So we have no intent to spread ourselves thin and go under some therapy areas that will take us away from all of that while we're launching the CIPA and the SCIPA. I'm saying launching the CIPA because I think we still launch more than the U.S., right? So that's the focus on cardiometabolic analysis. Now, if we say we're so clear about this, you know, focus area, we cannot say, oh, but then let's only focus on, you know, primary care style, large population assets because that limits our sphere of assets dramatically and we believe that whether it is in primary care specialty or rare diseases top leadership scientific associations are more or less the same it will allow us to evolve our go-to-market model by the way but we're very open because we're very nimble and we can adapt to different asset types because we believe we have the talent and the experience in this space. So that's with regards to diversification. I hope this was sufficient.

Thank you. Thank you. Thank you. The next question is coming from Louise Chen from Cantor. Louise, your line is live.

Hi, thank you for taking my questions here. So first question I had for you is, you know, you do talk about sort of a stabilization in US sales here. Maybe just a little bit more color on what gives you confidence. I know that you talked about how you plan to get there and then the timing, if there's anything that you could give us elaborate a little bit more on when you think you might see that. And then how should we think about the operating expenses and fourth quarter 21? I know you talked about a little bit of lumpiness, so maybe if you could help us there or just give us some broad strokes, it would be great. And then just last thing here is as you look at the global opportunity, Outside of that $1 billion, you also have China and Hong Kong and other areas of the world. So when you look at the global opportunity, where do you think peak sales could get to? Thank you.

Great. Thank you, Louise. So first on the U.S. sales, I mean, our announcement that came out like a month or so ago about the change in the go-to-market strategy is to respond to the challenges that we see. So we're very conscious that at this point in time, With our execution, but also with the dynamics that are taking place. We are not delivering the growth that we want And that's why we made changes now with change comes a bit of disruption, temporarily. Let's be very real. I mean, our 300 people that we have on the field today are incredibly qualified. We believe strongly that they are the right group to lead this next phase of the growth. Having said that, for many of them, they're going to have 50% change in their target audience. They're going to be now, in this first month, meeting people that they have not met before. that there need to establish working relationship, that they need to understand where are those physicians on the prescribing continuum. Are they believers? Are they non-believers? What do they need to do? So there will be a period where we're making this foundational effort to say okay this is a new page this is a new era this is a new team let's go and see how far we can go so it will take us you know a couple of quarters to basically you know anchor ourselves and get this new go-to-market um you know strategy to to operate but at the same time we are starting very aggressively all the digital omni channel um as early as you know from weeks, simply because that was one part of the strategy that we could press on the button and immediately engage with a far broader group. So this is to say we're making every effort to advance. Certain elements of this go to market strategy will take time to get the results we look for, but some we hope we will get earlier results. and over the next few quarters, as we said, we will track and reevaluate. We're not looking at this, oh, we know exactly what will change the growth trajectory. We know that these are changes we have to make. If we don't make them, then we're really not looking to ourselves in the mirror and accepting the realities of the market. So that's on the US growth and making sure we address that. In terms of operating expenses, I'm sure you've seen that up to now, We've been very measured in being on top of the expenses simply because we know we have a long investment journey and we're trying to dedicate all our investments in revenue generating as much as we can. We know that this last quarter we did so much more in terms of effort and activity beyond what we did in Q3, right? So obviously we expect that we're going to see, you know, a higher level of, you know, operating expense. But the most important part is that we still believe that we're well financed, that we have, you know, the right level of cash needed for us to drive the growth and the launches in Europe over the next few quarters.

Mike, you want to add something? I was just going to say US continues to be profitable, and that funds further growth. Yeah.

Great. Now, going to the global opportunity and the size of the business there, so you've seen that on those 20 additional markets. We say that there is a potential up to $1 billion in those 20, and we are not counting there, really, China, Canada, and the Middle East Africa region. out of those three the most important opportunity is definitely China at this point in time if you look at I mean what statins did in China we see that between the two statins we have more than one billion you know dollar of sales so there is a very very significant you know opportunity and and we are you know we continue to work with adding to support the regulatory process where we stand today. But definitely there is another huge opportunity there. I'm not sure we're ready to sort of quantify that at this stage. But let's get the regulatory approvals because already, as you know, with the Chinese regulatory authorities, you usually have in the process silence, silence, silence, silence. and then at the 11th hour you get so many questions to address and we're in that phase of interacting with them intensely we'll see how is this going to evolve over time. Thank you Luis. Thank you.

Once again ladies and gentlemen if you wish to enter the queue you can press star 1 on your phone at this time and the next question is coming from Paul Choi from Goldman Sachs. Paul your line is live.

Hi, thank you, and good morning, and thank you for taking our questions. I want to maybe just ask about growth to net and pricing dynamics here as you see growing market share and impact from the generics here. Can you maybe just comment on what the sequential trend has been in terms of realized net price here and just how you think about that potentially being impacted in 2022? Yeah, thanks, Paul.

you know on the gross to net I think we communicated twice that we are going to be opportunistic you know with certain plans to ensure that we eliminate any barriers that exist for the prescription this is related to the genetics but even unrelated to the genetics in a way right it's an effort that we are making and what we've seen so far is that you know our overall average net price at the national level has been impacted but really you know I think over many quarters maybe less than one percent we see that not changing dramatically so there will be a very very potential slight decrease in net price but I would not look at that as anything beyond what would be expected in a regularly competing product in the market right I don't see us doing something Thank you that's very helpful color cream and then maybe as a follow-up here just with regard to the countries in which you file the dossiers and you could be in a position to have

Near-term distribution arrangement. Can you maybe just update us on where you are on the status of identifying and Contracting with a potential partner for those geographies and when do you think that would potentially be finalized? Thank you very much Thanks.

So so on the on the question of partnership So we already initiated the process for Central Eastern Europe and we started to engage with a number of countries and you know obviously this is a process that takes time because you need to receive the request you need to do your diligence you need to you know qualify which type of partner you're really going to work with are you receiving a country by country request are you receiving regional requests what deal is better is is it better to do a country by country versus regional so you have to wait until you receive actually all all the requests and be able to compare and contrast between them. So this is ongoing for Central Eastern Europe. We have not yet initiated this process for those 20 additional countries that we are pursuing on the international level. That process has not started. We only have started the process of regulatory submission so that we have an approval, but we are not gonna delay for very long that process too simply because the six countries and we mentioned some of them many of these countries we believe based on their timelines that we can achieve regulatory approval in 2022 so because we will achieve that we will need to have partners ready in these in these countries so we plan to initiate this process very early in the year 2022. okay thank you very much thanks thank you

and the next question is coming from Jessica Phi from JP Morgan. Jessica, your line is live.

Hey guys, good morning. Thanks for taking my question. Can you break out specifically, and forgive me if I missed this, what were European revenues in the third quarter?

I believe we reported them, but there were very, very little revenues in the third quarter. Off the top of my mind, I think it was maybe $400,000 or something like that. Yeah, $200,000. So there was very little revenue. I will just clarify a little bit how it works in many of these countries. So first of all, you cannot receive your wholesaler contracts and sign them until your price is public, just for you to imagine. Price only became public on September 1st. So, if you want to engage with wholesalers, that's when the clock starts. So, you know, month of September is really a rush to sign wholesaler contracts, make sure that some of these are going to put orders, that the pharmacies are going to be filled with some supply. The product was not listed on the electronic prescribing system. until October 1st. Not because we decided to delay, but because the German system, they update their electronic prescribing system every quarter. And you have to actually submit your request one month prior to that quarter. So we submitted the day of the price. because you cannot submit before your price is public. So all of this was almost sequenced by the day to ensure that we have a price listed on September 1st to allow us to be in the electronic prescribing system by October 1st. Having said that, even when you become in the electronic prescribing system, you're still very new, many physicians and the wholesalers are not going to fill up any pipeline until they see key requests from the pharmacist. So the process takes time, especially that this was our first country. And I'll remind that in Germany, we will have the shortest period of pre-launch. In many of the other countries, We're in pre-launch mode today, right? We have medical teams educating. If you see some of, you know, on the social media stuff, you'll see that our Spanish team is working with a lot of medical events, you know, other teams in the Nordics. So that effort, unfortunately, we didn't have this luxury in Germany. We are now catching up with all of this because of the limited time. So that's really... clarifying revenue and revenue expectations within the very first data points for the German logs.

Great, thank you.

Thank you. There were no other questions in queue at this time. I would like to hand the call back to the Ameren management team for any closing remarks.

Great, so thank you all so much. We're happy that we were able to address you know all questions thank you for your participation your contribution and we look forward to connect with you again at the next earnings call in 2022 thank you thank you ladies and gentlemen this does conclude today's conference call you may disconnect your lines at this time and have a wonderful day thank you for your participation