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spk03: Greetings, and welcome to the Alkermes Q2 2021 Financial Results Conference Call. My name is Alex, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to Sandra Coombs, Vice President of Investor Relations. Sandy, you may begin.
spk09: Good morning. Welcome to the Alkermes PLC conference call to discuss our financial results and business update for the quarter ended June 30, 2021. With me today are Richard Pops, our CEO, Ian Brown, our Chief Financial Officer, and Todd Nichols, our Chief Commercial Officer. Before we begin, I encourage everyone to go to the investor section of Alkermes.com to find our press release and related financial tables, including a reconciliation of the gap to non-gap financial measures that we'll discuss today. We believe the non-GAAP financial results in conjunction with the GAAP results are useful in understanding the ongoing economics of our business. Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see slide two of the accompanying presentation, our press release issued this morning, and our most recent annual report filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments. After our prepared remarks, we'll open the call for Q&A. Now I'll turn the call over to Richard.
spk14: That's great. Thank you, Sandy. Good morning, everyone. We had a strong second quarter. A number of good things happened. Excellent commercial performance and other positive developments all demonstrating continued execution against the priorities we outlined at the beginning of the year. Vivitrol, Aristata, and Vumerity each showed strong year-over-year and sequential growth. These elements of the revenue line, coupled with a disciplined focus on costs, drove our financial results. We've reported robust non-GAAP net income for the second quarter, and we're increasing our guidance for the year. The FDA approval of Le Balvie represents another meaningful growth opportunity for the company, and a value of the pipeline has also become more evident, with Nambalucan advancing and other candidates progressing as planned. Current revenues, emerging revenue streams, an advancing pipeline, and a focus on efficient management of the business. Each of these elements of the company's strategy provides a significant opportunity to create value. I'm going to start with a bit on LaValvie. Our first approved oral antipsychotic Lebalvi will leverage our commercial infrastructure and represents our next revenue growth opportunity. Lebalvi is indicated for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The label is strong, and it reflects Lebalvi's features. We believe we'll be able to differentiate this medicine in a large market based on its clear attributes and a simple message. Lebalvi captures the established efficacy of olanzapine with less weight gain. We've been establishing our commercial capabilities and presence in the schizophrenia market for five years with Aristata, our long-acting injectable antipsychotic. Building on these capabilities and developing a franchise of treatments for serious mental illness has been a centerpiece of our long-term strategy. The commercialization of Levalvi will leverage our experience and expertise in this complex commercial setting, and this is already underway. Since approval, we've engaged with hundreds of thought leaders and healthcare providers and expect to launch Levolvi into a market with a strong baseline awareness of the medicine and its differentiating attributes. And you'll hear more about this from Todd in just a couple minutes. Olanzapine is widely recognized as being highly efficacious, but physicians and patients often avoid prolonged utilization due to concerns about its propensity for weight gain. Lebalvi provides an opportunity to harness the efficacy of olanzapine as a maintenance therapy in schizophrenia and bipolar I disorder with less weight gain. When we set out to develop innovative medicines, our guiding principle has always been to make medicines that address the real-world challenges faced by people living with complex and serious diseases. And Lebalvi reflects this focus. I think we can tell a similar story about nimbolucan. Nemvalucan is our novel investigational engineered IL-2 variant immunotherapy, designed to capture and expand the proven efficacy of IL-2 while engineering out certain of its limiting side effects. The development program has progressed rapidly. In the last 12 months, we've achieved clinical proof of concept in two indications that we plan to advance into registrational studies. We enrolled over 200 patients in the clinical development program. entered into a clinical trial and supply agreement with Merck for our planned Phase III study in platinum-resistant ovarian cancer, secured FDA orphan drug designation for mucosal melanoma, and worked with FDA to agree upon registrational pathways in both of these difficult-to-treat indications. Last month, we provided a substantive clinical update at ASCO, and were joined by the lead investigators for both Artistry I and Artistry II studies, who shared their clinical perspectives and experience with Nemvalucan. That presentation is on our website. If you haven't seen it, I recommend taking a few minutes to watch it. It'll give you a sense of the current status of the program and the significant progress that we've made. Nemvalucan is accumulating a clinical data set that we believe differentiates it from the other IL-2 variants in development. It has demonstrated responses in high unmet need populations across a range of tumor types. including durable and deepening responses in Artistry 1. Our clinical development strategy is focused on addressing unmet needs, and we focus on difficult-to-treat patient populations, including patients with checkpoint inhibitor unapproved tumor types and patients in the post-checkpoint inhibitor setting. The studies planned for this year, including the Artistry 6 study in melanoma, which we've already initiated, and the planned Artistry 7 Phase 3 study in platinum-resistant ovarian cancer, are designed to support potential registration. We're moving ahead now with momentum and look forward to sharing our progress across the program with you. So before I conclude, I'm going to take a moment to acknowledge the efforts of our talented and dedicated employees who've remained focused and committed to the patients we serve over the past 18 months, despite the challenges and the constantly changing environment. Our commercial and operational success during this time is a testament to their agility, innovation, and perseverance. Q2 was a pivotal quarter for the company. Strong commercial, operational, and financial execution, FDA approval of LaVolvi, the accumulating data and the operational progress across the Nemba Lucan Development Program, all of these provide a strong foundation for growth and execution for the balance of the year. I'm going to turn it over now to Todd and Ian to take you through the Q2 results and our improved financial expectations for the year. Todd?
spk10: Great. Thanks, Rich. And good morning, everyone. Our commercial team delivered strong performance in the second quarter. Our execution, together with continued improvement and new patient starts, contributed to the highest quarterly net sales for Aristata to date and a return to pre-pandemic volumes for Vivitrol. Based on our results in the first half of the year and our expectation that current trends in the treatment landscape will continue, we are raising the bottom end of our full-year net sales expectation ranges for both Aristata and Vivitrol. Ian will fully outline these revised expectations shortly. Starting with Vivitrol, net sales in the second quarter increased approximately 23% year-over-year to $88.4 million. Q2 Vivitrol unit demand reflects improved access to treatment since the height of the pandemic. The recovery of Vivitrol has been driven by increased adoption in the alcohol dependence indication, and we continue to focus on our strategy of increasing awareness of Vivitrol as a treatment option for alcohol dependence among providers, caregivers, and patients. Our recent market research showed that 80% of healthcare providers surveyed believe the prevalence of alcohol dependence has increased in the past year. Consistent with this research, the alcohol dependence treatment market has grown at a faster pace than the overall addiction market over the same timeframe. The recovery of prescriptions for opioid dependence has been slower, both for Vivitrol and other treatments. despite increasing opioid overdose deaths across the country. We believe this is in part driven by pandemic-related disruptions that persist in the treatment system, as certain settings of care, including residential treatment centers and government treatment locations, have yet to fully return to their pre-pandemic operational capacity. We are committed to continuing our work to support patients and healthcare providers during this pressing public health crisis. Turning now to the Aristotle product family, net sales in the second quarter increased approximately 23% year-over-year to $72.4 million, driven by strong TRX growth on a month of therapy basis of 15% year-over-year. This growth outpaced the broader long-acting, a typical antipsychotic market growth of 5%. We have continued to see positive recovery trends in the long-acting antipsychotic market in recent months. Health care providers reported an increase in patient visits as offices reopened. The number of diagnosed patients increased and prescriptions volumes grew sequentially. While the COVID-19 pandemic is not behind us, recent trends in prescription and patient volumes and access to health care providers in both the addiction and LAI markets are encouraging. Notably, our sales force expanded the percentage of their in-person calls to approximately 70% in June, up from 50% in March. As we enter the second half of the year, we are monitoring the emergence of variants in local conditions carefully as potential new COVID-19 hotspots arise, and we'll make adjustments to our commercial strategy as necessary. I'll end with an update on our launch activities for LaVavie, our new oral antipsychotic agent. During the second quarter, the FDA approved Lebalbi for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder. We are pleased with the approved label, which includes data showing that treatment with Lebalbi was associated with less weight gain than treatment with olanzapine and proven antipsychotic efficacy. Initial feedback on the label from thought leaders and the treatment community has been encouraging, and we believe that anticipation for product availability is building. This will also be our first opportunity to realize the synergies of adding an additional product to our psychiatry franchise. As of all, we will join Aristotle in our psychiatry product portfolio and leverage our existing commercial infrastructure and expertise in this market. We are currently laying the foundation for a full commercial launch as we engage with healthcare providers to build awareness and demand ahead of putting product in the channel in the fourth quarter. AHCP awareness of Labavi has been steadily increasing over time and we believe we are well positioned for launch. Hiring is underway for our open Salesforce positions and we are impressed by the caliber of talent that Labavi launch is attracting. With the label now in hand, we submitted our promotional materials to OPDP for review and are excited to launch our new campaign. In this first phase of launch activities, prior to product availability, we finalized our speakers bureau, which we will begin to deploy in the fourth quarter and have also focused on increasing our engagement with payers. The large potential patient population, the clear need for additional efficacious treatments, and the features of Labavi as reflected in the label provide a meaningful opportunity in the oral antipsychotic space. As the country continues to reopen and the frequency of in-person promotional activities increases, we believe we will be well positioned for a successful launch in the fourth quarter. Looking ahead, we are focused on execution as we advance launch activities for Labavi, work to achieve our expectations for Vivitrol and Aristata, and continue to drive awareness of the value proposition of these important medicines. Now I'll turn the call over to Ian to review our second quarter results and our updated financial expectations for 2021.
spk08: Thank you, Todd, and hello, everybody. We're pleased with our Q2 results as we delivered strong top-line growth and reported both positive GAAP net income and robust non-GAAP net income. Based on these results and our expectations with respect to the ongoing recovery from the COVID-19 pandemic, today we're raising our financial expectations for 2021. I'll provide additional detail on these expectations in a moment, but first I'll start with an overview of our second quarter financial highlights. For the second quarter of 2021, we generated total revenues of $303.7 million, representing a year-over-year increase of approximately 23% and a sequential improvement of 21%. This was driven by the strong performance of both our proprietary commercial products and key products from our diverse portfolio of manufacturing and royalty revenues. This strong revenue growth, combined with our continued focus on disciplined operating expense management, drove a gap net income of $2.4 million and a non-gap net income of $49.2 million for the quarter. Vivitrol net sales in the second quarter were $88.4 million, driven by a 29% increase in units year over year, due in part to an improvement from the significant pandemic-related disruptions in the treatment system in the second quarter of 2020, and also the execution of our strategy to increase awareness of Vivitrol as a treatment option for alcohol dependence. This unit growth was partially offset by higher gross to net adjustments in the quarter of 51.8%, as compared to 46.4% in the second quarter of last year. Q2 gross to nets were consistent with Q1, and in Q2, inventory levels increased sequentially by less than $2 million, in line with both increasing demand trends and typical seasonal patterns. Driven by these results and favorable gross to net adjustments, we're raising the bottom end of our 2021 expectations for Vivitrol net sales by $15 million, from a range of 315 to 345 million to a range of 330 to $345 million. We now expect gross to net adjustments to be approximately 52.5% for the full year, driven by lower than expected Medicaid rebating and an improved product return rate. Turning to the Aristada product family, net sales in the second quarter increased 23% year over year to $72.4 million, primarily driven by underlying unit growth. During the second quarter, gross to net adjustments for Aristada were 54.8%, consistent with our expectations for the year. Inventory levels did increase during the quarter by approximately $6 million, as a number of key customers adjusted their inventory to support the growing demand. Based on the current trends outlined by Todd, we're updating our expectations for Aristada net sales for the full year, raising the bottom end of the range by $15 million, from a range of $260 to $290 million to a range of $275 to $290 million. Moving on to our manufacturing and royalty business, in the second quarter, our manufacturing and royalty revenues were $142.3 million compared to $116.5 million in the prior year. This increase was driven primarily by accelerated uptake of Vumerity, which contributed $20.3 million of total revenue in the quarter, and also growth of royalty revenues from Invega, Sustena, and Trinza. This continued growth is reflected in our increased financial expectations for the year. Total operating expenses increased 6% compared to the same period in the prior year, driven primarily by higher cost of goods sold, largely due to increased revenues, and increased sales and marketing investments for the upcoming launch of Levolvi. Specifically, cost of goods sold increased to $53.1 million compared to $45.1 million in the same period of the prior year, R&D expenses for the second quarter were $97.5 million, compared to $94.2 million for the prior year, reflecting increased patient enrollments in the ongoing Nembolucan clinical studies and the initiation of the Artistry VI Phase II melanoma study. SG&A expenses for the second quarter were $139.2 million, compared to $132.0 million for the prior year, which included incremental investment to support the approaching launch of Levolvi. As we continue to lay the foundation to achieve the profitability targets that we set forth for 2023 and 2024, we're focused on carefully managing our operating expenses and prioritizing investments in the company's strategic priorities and future growth drivers. Turning to our balance sheet, we ended the second quarter in a strong financial position with approximately $670 million in cash and total investments, and total debt outstanding of $297 million. I'll shift now to our revised financial expectations for 2021, which reflect the strong operational performance in the first half of the year, continued recovery from the pandemic, and our focus on disciplined expense management. Our full expectations are outlined in the press release we issued earlier this morning. We believe these revised ranges are appropriate based on current trends and our expectation that treatment provider practices and patient flow will continue to normalize. However, any new COVID-related disruptions may impact our ability to meet these expectations. For the top line, we now expect total revenues to be in the range of $1.145 to $1.185 billion, an increase of $30 million at the midpoint, driven by both higher proprietary revenues and higher manufacturing and royalty revenues. We're also adjusting the ranges for certain operating expense line items with changes of the respective midpoints of each range as follows. Our expectation for cost of goods sold increased by approximately $5 million, driven primarily by the higher revenues. Our expectation for SG&A expenses decreased by $10 million, primarily due to refinements to our launch plans for Lee Bowlby. And while R&D expense expectations remain unchanged, recall that we are anticipating a $25 million milestone payment in the third quarter related to the submission of an IND or equivalent for ALKS 1140, the first clinical candidate to emerge from our HDAC inhibitor platform. The strength of our top line and our disciplined expense management are together driving improvements in our profitability. Our expectation for gap net loss has improved by $30 million, and our expectation for non-gap net income increased by $20 million to a new range of $85 to $115 million. Looking ahead, we're focused on driving continued growth of our proprietary commercial portfolio and capturing operating leverage as we launch Levolvi, while at the same time advancing the Nemboloocan development program and investing in our early stage pipeline. We believe we are financially well positioned to execute on our business strategy, drive profitability, and support shareholder value creation in the years to come. And with that, I'll hand the call back over to Rich.
spk14: That's great. Thank you, Ian. I'll finish briefly. I'll just say, looking ahead, I'm encouraged by the outlook for the business. Vivitrol, Aristata, Lebalvi, and Vumerity each represent a growing or new revenue stream. Our infrastructure has adapted to support these products as efficiently as possible. Vivitrol is supported by a bespoke and efficient set of capabilities designed specifically to maximize the medical and economic value of the singular medicine addiction market. Aristata and Levolvi are synergistic and provide significant opportunity to drive operating leverage with our purpose-built psychiatry infrastructure. Bumerity is growing, and our commercial partnership with Biogen delivers pre-tax profit directly to the bottom line. Together, the revenues from these products have the potential to drive significant growth over the coming years. The longer-term potential growth drivers for the business are the development programs in our neuroscience and oncology pipelines. Each program is designed to address specific unmet needs, leveraging our scientific strengths. Our objective is to develop truly innovative medicines with a clear value proposition. Membalucan is the most prominent and advanced asset in the pipeline, but we're equally excited about our earlier stage programs. I look forward to sharing updates from our HDAC, orexin, and the engineered cytokine portfolios as they advance toward the clinic. With an intense focus on business excellence, financial discipline, and effective capital allocation, we believe we're well positioned to create value for our stakeholders, including patients, healthcare providers, caregivers, our employees, and our shareholders. And with that, I'll turn the call back to Sandy for the Q&A. Great.
spk09: Thanks, Rich. Alex, we'll open the call for Q&A now.
spk03: Thank you. At this time, we will be conducting a question and answer session. If you'd 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 two if you'd 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 star keys. Our first question comes from Vamel Devon with Mizuho Securities. Please proceed with your question.
spk04: Hi, great. Thanks for taking my question. So maybe if I could just have two. So one on Vivitrol. I heard the comments you made around the dynamics in the alcohol versus opioid process. market, can you maybe just quantify your performance? You know, this this quarter, just to get a sense of how much of it is coming from alcohol versus opioids, or maybe if you want to talk about, so we're looking forward, I expect the growth between the two, to, to differ. And then the other one would just be on nambulokin. And obviously, some of the updates you guys had at ASCO, maybe you can just sort of comment on what we should expect from that product in terms of data in the second half of the year, whether as more sexy or otherwise. and any updates you might have in terms of the collaboration discussion I think you've been having with larger partners for that program. Thank you.
spk10: Good. Okay. I'll start off with Vivitrol. You know, the visibility that we have is through claims data and through also our own hub reported data. It's a little bit lagging. Our belief and what we see in the data so far is that the mix of business between alcohol and opioid is remaining about a 50-50 split. We are expecting that the alcohol dependence indication will continue to grow, and we're encouraged by that. One of the areas that we're encouraged in is really looking at diagnosed patients. When you look at the diagnoses right now, Quarter over quarter, we're seeing alcohol dependence as a market at large growing at approximately 5%. And then we also take a look at just new patient starts or NBRXs, which is also a leading indicator for us. Overall, the market NBRXs is up approximately 2% to 3%, and Vivitrol NBRXs are up about 10% quarter over quarter. So again, we believe it's about a 50-50 split right now. All of the indications are telling us and all of our qualitative research from physicians are telling us that alcohol dependence is growing and that utilization for Vivitrol and alcohol dependence is growing. So we're expecting that to continue into the back half of the year.
spk14: And Bob, maybe I'll take the first part of the second part of your question. I have Sandy give you the update on data. So the important part about the ASCO presentation Just to summarize, I think the real differentiation of nebulucan is becoming clear on at least three different fronts. One is the molecule itself in terms of its intrinsic pharmacologic properties and the way it's driving. Then the second differentiating feature, which is the clinical data, where we're showing monotherapy efficacy as well as efficacy in combinations with PEMBRO in a range of different tumor types. in both checkpoint inhibitor unapproved and approved settings. And then the third point of differentiation, I think, is the registration strategy, going for this white space of serious unmet needs as evidenced at the beginning by mucosal melanoma and platinum-resistant ovarian cancer. So all of this together provides a foundation for our advancing these discussions with potential partners, because partnering Nembolucan remains a centerpiece of the strategy because of its potential utilization in so many different categories and different combinations and different tumor types. So I won't comment on specific discussions on that. Just know that that's something that's an intense focus within the company, and we'll update you as we make progress.
spk09: And in terms of data flow for Nembolucan, we did just provide a fairly comprehensive and substantive update at ASCO. The data from Artistry 1 and Artistry 2 continue to mature, and we'll monitor that data and determine the appropriate medical meeting form to present those data at in the future. We'll intend to have a presence at ESMO and CISI, but it's premature to commit to which data sets will be highlighted at those meetings.
spk06: Okay. Thank you.
spk03: Thank you. Our next question comes from Corey Kasimov with JP Morgan. Please proceed with your question.
spk02: Hey, good morning, guys. Thanks for taking my questions. Two for me as well. I guess one, I just wanted to follow on Vivitrol and this notion of alcohol versus opioid. I understand what the dynamics of COVID and what's happening in the marketplace today is. But longer term, has your thinking evolved here in what and how you're looking at the relative contribution from these two segments? And then I wanted to also ask if you can comment a little bit more on the SG&A expectations. You have the lower anticipated guide ahead of the LaValle launch. It's not a lot, but it's not also typical in a situation like this. So I'm wondering, is this just a function of some of that spend being pushed into 2022? or more about leveraging Aristotle, or is there something else there that I'm missing? Thank you.
spk10: Good morning, Corey. I'll take the first question on Vivitrol and how we're thinking about it. At Alkermes, we've always had a focus on alcohol and also opioid. We've worked on the evolution of our strategy for the last 12 months or so. We really believe that there's an opportunity to further expand growth in the brand for not only opioid, but more holistically for the alcohol indication. If you think about the market at large, there's 14 million patients that actually have a diagnosis of AUD, but there's only 400,000 that are actually on treatment right now. So the penetration for treatment is relatively low. When we do all of our research right now, we talk to physicians, Again, 80% of physicians right now are telling us that they believe that they're seeing an increase in alcohol dependence with origination levels that are very strong at this point. We also ask them very consistently their view on medication. 70% of physicians report to us that they believe that medication is important. So our opportunity is really to build awareness in the patient community right now around medication and not just the stigma, because this is a medical condition as well. When we look overall at just the overall dynamics of the business at a subnational level, we're actually seeing consistent growth in the majority of the states right now and also within the outpatient settings. For example, community mental health centers are actually showing strong double-digit growth. Most of these centers are really focused on alcohol at this point right now. So we do believe that there's an opportunity long-term to drive awareness. and to drive a greater penetration for patients that suffer from this disease. And we believe that the Vivitrol can play a big part in that.
spk08: And then, Corey, on the SG&A expectation side, I would say we've really been able to fine-tune the launch expectations subsequent to approval and with the label on board, which we're obviously very happy with. The focus is very much to leverage the existing infrastructure that we have for Aristata, And I think as you look at the timing of spend, we'll increase investment into Q3, and then there'll be a bigger step up in the fourth quarter as we'll have all the reps on board, all the marketing materials will be available for the launch, which we expect to happen in the fourth quarter. So I think that's the way we look at SG&A expense in the second half of the year.
spk02: Great. Thank you very much.
spk03: Thank you. Our next question comes from Brandon Folks with Cantor Fitzgerald. Please proceed with your question.
spk06: Hi, thanks for taking my questions and congratulations on a very good quarter. I just want to drill down on the pivotal opioid headwinds you called out. Can you just elaborate how these headwinds we're seeing at the moment compared to your expectations maybe at the beginning of the year? Are we seeing improving trends, a little bit worse? any color there and then if you can just elaborate obviously you know we've seen opioid deaths go unfortunately the wrong way um so are these headwinds really just coming from patient demand going into a facility or is there some funding gap at stake as they grapple with covid just any color in terms of how you may see these headwinds in the opioid space progressing thank you yes absolutely brandon first and foremost there's no gaps in funding
spk10: at this point right now. I'll just make a quick comment on that. Medicaid is the primary source of access for Vivitrol. We have very strong access within the Medicaid segment. There has been additional federal funds released. We don't have visibility, as we've said in the past, at state-level grants that are available, but we know there's a significant amount of funding that is available, and our belief is that eventually that will trickle down at the subnational level and will be used for MAT programs and programs such as Vivitrol. We're very encouraged by that as well. When we think about overall the market and the landscape with the market as well, I would characterize it this way, that we're actually starting to see a stabilization for opioid dependence. We knew there were significant headwinds in 2020 based upon access to treatment providers, access to injections. We adapted our commercial strategy to a hybrid personal promotion and did a lot of work in the pharmacy space to make sure that patients have access to treatment overall. We're continuing to see some headwinds, mainly in the controlled settings of care. And that's really the primary space that Vivitrol is used for opioid dependence. These are going to be residential treatment centers. These are going to be certain federal facilities, such as the VA, Indian Health Services, and so forth. I would say in Q2, we're starting to see some encouraging trends there. On a quarter-over-quarter basis, we're seeing growth in those segments, but it's still not back to the levels that we would expect back from 2019. So the headwinds mainly that we're seeing within opioid dependence right now are based upon the controlled settings of care, improving access for patients that need detox services. And our belief is that as the pandemic continues to improve, access to providers, access to services will improve, and we'll continue to see a stabilization with that business.
spk06: Very helpful. Thank you.
spk03: Thanks, Brandon. Thank you. Our next question comes from Paul Matisse with Stiefel. Please proceed with your question.
spk01: Great. Thanks so much for taking my questions, and congrats on the quarter. For LaVolvi, I was wondering if you could kind of lay out what you think the payer landscape is going to look like at launch, and what's your goal over time, maybe in 2022 or 2023, Specifically, what do you think the step edits will look like for prescribing this drug initially? Do you think people will have to step through Zyprexa? And what do you think that looks like over the mid to long term? What's a realistic goal? Thanks so much.
spk10: Yeah, absolutely. I'll tell you, we are really excited about the launch of Levolvi. You know, as you heard Rich say, we actually are in the first phase of our launch right now. That started with approval on June 1st. And the first phase, the way that we think about this is we are extremely focused right now on building awareness. And the awareness numbers are increasing, which is very encouraging. We're doing that with HCPs, but we're also doing it with payers right now as well too. And we are executing engagement plans with payers and sharing the clinical profile. Payers are most interested in our clinical profile at this point. That was our expectations. Our medical team is out sharing the clinical profile. We've had well over 60 different presentations on our clinical profile, and it is encouraging. I think the way that we think about the payer landscape and the payer environment is there's three key segments of the business, Medicaid, Medicare, and commercial. They're roughly going to contribute an equal proportion overall. The profile of access will really emerge over the first 12 to 18 months, and that's very consistent with what you see with other branded competitors as well. So what we know and our assumptions are that the payers are on different timelines. You know, for Medicaid, it's a state-by-state plan. You know, we know where the top volume states are. We know when their decisions and their coverage decisions will be made. We know with Medicare that coverage decisions will be made when product is in the channel within the first 90 days. And we also know with commercial that, you know, you're going to see quite a bit of NDC blocks at launch, these payer restrictions. And that's That's not uncommon outside of just this category. And our belief is that'll be anywhere from six to nine months. So the way that we're thinking about this is we're going to have access programs at launch, PA support, benefits investigation, copay programs at launch, sampling programs at launch to help support access to the product, to help support trial and usage at launch. And the profile for access will really evolve over the first 12 to 18 months.
spk00: You want to comment on step-through?
spk10: That's right. Yes, the question on step-through. We are, you know, the feedback that we receive from payers is that Levolvi will be treated similar to other branded agents. So it's very common in the marketplace to have, you know, PAs, prioritizations, step-throughs. It can be one step-through, one step-edit, two step-edits. There is the potential to have a step-edit through a Lanzapine, so we are prepared for that with the programs that we have in place.
spk01: Great, thanks very much.
spk03: Thank you. Our next question comes from Umar Rafat with Evercore. Please proceed with your question.
spk07: Hi, this is Eric Masanza here speaking for Umar. Thanks for taking time for our question. Just to follow up on Lybulvy, ConsenSys is modeling about $70 to $80 million in sales for fiscal year 22. How are you thinking about those numbers relative to your learnings from recent antipsychotic launches? And separately, a different question on Boomerity. Could you clarify your policies on royalty rates and revenue recognition? We know the nominal rate's about 15%, but today's numbers imply about 23% of Biogen's reported net sales. Any detail you could give there?
spk14: So this is Rich. Why don't I start on the Baldy question? Obviously, we're not ready to give guidance for 2022 yet, but I do think recent launches indicate a couple things about the gradualness of access as it opens up over the course of the first year. And Todd referred to that, and it's built into our operational plan. We're actually funding our launch sequentially as access grows across the nation. We can then dedicate more marketing and personal resources to the launch of the product. Our view is that you can hold these two thoughts simultaneously, and that is A, that the launch can be gradual, and B, the ultimate market potential can be substantial. But these are not square wave launches in those different aspects of the business. Ian, you want to comment on the boomerity?
spk08: Sure. On the boomerity question, we really have two sources of revenue for boomerity. The larger one is the royalty, which, as you say, is 15% of end market net sales. So if you take Biogen's net sales for the quarter, multiply by 15%, that's our royalty. The other element is we do manufacture the product for Biogen as well on a cost plus basis. So that difference is really the manufacturing revenue that we earned in the period.
spk09: And I'll just add one comment to Rich's, LaVallee comments, and that's that not all of the models that we've seen have been updated to reflect a Q4 launch timing. So some of those models are gonna get pushed out a little bit, so I would expect that number to come down a bit.
spk07: Thank you.
spk03: Thank you. Our next question comes from Mark Goodman with SVB Learing. Please proceed with your question.
spk13: Hey, good morning. Rich, I was wondering if you can give us an update on the original strategic review with respect to how you're thinking about partnerships, how you're thinking about the divestitures, how you're thinking about your original margin goals that you laid out for us at that time. Thanks.
spk14: Yeah, I'm happy to, Mark. Obviously, the margin goals are a lot easier to achieve when you have the royalties, I'm sorry, when the revenue line is looking as robust as it is. That's why it's so important, I emphasize today, resumption of growth in Vivitrol, Aristata, Vumerity, and now with the turning on the spigot for Levalvi, we have the top line looks like it's going to be in really good shape. We've been very focused on cost management, as you know, for the past couple of years, and I think that that's And Ian spends a lot of time focusing on that, tuning that, so that we'll be able to hit those profitability targets. Central to that is this idea of partnering Nimbolucan, both from a financial perspective to offset certain R&D expenses associated with it. It's our largest R&D expense right now. But also just to realize the full medical potential of the drug, because it's actually designed for use in combination with other agents and in multiple cancer settings. So I think partnering remains a really central part of the plan as well.
spk13: Are we in discussions for these partnerships? Are they going well? Can you give us any sense of when you might have some help to defray some of these costs? Is this by the end of the year?
spk14: Yeah, I'm not going to put a timeline on that for obvious reasons, but they're important for us to do, and they're also important for us to do in the right configuration with the right partner. This will be hopefully a long-term relationship that's going to have substantial strategic value to the company, so we're going to make sure we do it correctly.
spk13: Okay, thanks. Thanks, Mark.
spk14: But the only thing, the color I'll give you, Mark, is just that what is the tailwind for partnering are the data. And that was so important about the ASCO presentation that we made just a month or so ago, is that the data are really coming together nicely. And that's been a necessary prerequisite for serious partnering discussions. So we're encouraged by the way that that data set is building, and I think that's going to continue to help us.
spk13: Thanks. Yeah.
spk03: Thank you. Our next question comes from Terrence Flynn with Goldman Sachs. Please proceed with your question.
spk11: Hey, good morning. This is Matt on for Terrence. Thanks for taking our question. With regards to the NIMBA-Lucan partnership, could you talk about what you'd view as an ideal structure for such a partnership? And then also in terms of monetizing any non-core assets, what would be your focus for cash?
spk14: Yeah, I think that the features of an envelope of partnership are a couple of principle ones. One is with a partner or counterparty that's a strong oncology developer or someone who would just augment our development capabilities substantially. Number two is obviously offsetting significant amounts of the R&D spend. But that's associated with number three, which is broadening the indications that we're going after for nepalucan. We have intentionally, after a period of time in the clinic of signal exploration, we've coned down the program now into these registrational pathways in mucosal melanoma as monotherapy and in platinum-resistant ovarian cancer in combination with PEMBRO. But there are other indications. We get indications from clinicians regularly now looking for additional combinations, different places to go. We've been avoiding those, focusing the spend on these most advanced registration pathways. So the quality of the partner, the financial commitment to it, and the ability to expand the footprint for the development program, both in terms of indications as well as regionally or globally, those would be important features for us to consider.
spk00: Go ahead, thanks.
spk03: Thank you. Our next question comes from Kelly Shee with Jefferies. Please proceed with your question.
spk12: Hi, good morning. This is Jason Bouvier on for Kelly Shee. And you may have just addressed my question, but we're wondering, just for nimbilucan, besides melanoma and ovarian cancer, what do you think are some of the other most promising indications based on efficacy And then which ones do you think, you know, are the most promising to move to the next phase? And then the clinical bar and regulatory bar for the melanoma registrational trial. Thanks.
spk14: Yeah, I think in general, in the NEMVA liquid program, we're really interested in this white space and places where patients are being treated. where checkpoint inhibitors have not shown robust efficacy or post-checkpoint inhibitor failure. That's both in combination with a checkpoint inhibitor like PEMBRO, but also potentially in other combinations. You saw us present some data at the Investor Day, and we presented publicly on some work we've been doing with tyrosine kinase inhibitors. The TKI combination with IL-2 variants is really encouraging as well. So the white space is both different combinations of as well as different tumor types, but again, I think our preference at this point is to, rather than looking at tumor types where we're looking for nemlalucan plus a checkpoint inhibitor to increase efficacy in approved tumor types in indications where there is currently no checkpoint inhibitor therapy or that checkpoint inhibitor therapy is limited. I forget the second part of the question.
spk09: The clinical bar for ARDIS 3.6 and ARDIS 3.7, what types of response rates are we looking for? We haven't disclosed the study design details for ARDIS 3.7 yet or provided details on that, so that will be forthcoming once we initiate that study. For ARDIS 3.6 in melanoma, this is intended to support potential registration in mucosal melanoma. which is severely underserved and has high admit needs. So there's not a lot of treatment options that these patients have left. We haven't provided a specific ORR or durability response rates that we're looking for. We'll really look at it as a holistic data set and review that with the agency to support potential approval once we have the data from that study.
spk14: Yeah, I think that's an important point that Sandy makes because it's not just an overall numerical response rate. One of the promises of IL-2 therapy, of course, has been the durability of these responses. So it's this combination of response rate and the durability of those responses that will provide the overall profile of the medicine that could support registration.
spk12: Great. Thank you. Very useful.
spk03: All right. Thanks, Jason. Thank you. Our final question comes from Jason Gerberry with Bank of America. Please proceed with your question.
spk05: Hi. This is for Jason. Thanks for squeezing me in. I would like to go back to Vivitrol. Thanks for all the colors that you have provided regarding the OPR and the alcohol contributions. But curious, on a net basis, it looks like 2q cells are pretty similar to 2q19 level. So on a net basis, do you feel like you're back to pre-COVID levels in terms of how the franchise is operating? Just curious, you know, as we look ahead to 2022, you know, do you, how should we think about the franchise to grow? Do you, should we look at 2021 as the base year or, you know, do you expect an accelerated surge in demand if, you know, things as a whole haven't quite fully materialized yet, normalized yet, I guess, you know, do you, expect, you know, OPR to pick out, whereas, you know, the tailwind to alcohol may be moderating as COVID subsides. And then secondarily, you know, related question, how should we think about the gross net adjustment for Vivitrol? You have lowered the gross net expectation for the full year by about 250 basis points. Should we think about 52.5% as a go-forward basis, or should we think about more in the mid-50% range as the go-forward basis? Maybe it also goes back to the contribution of the OPI and alcohol dependency, but any color you can provide, that would be great. Thanks.
spk10: Yeah, I'll start first with the comparisons of what we're looking at. We're taking a sharp look at performance relative to 2020, but we're also really looking hard at 2019. you know, the performance that the brand contributed in 2019. Our belief based upon our market research and what we're seeing in the marketplace right now is that the contribution to alcohol dependence will continue to grow. So our expectations are when you look at just overall market growth, that you're going to continue to see stronger market growth for the alcohol dependence market, which we're seeing. You know, we're expecting that to grow at approximately 15% this year. We're expecting the opioid market to grow at approximately 7%. And so we're adjusting our strategy, our commercial strategy to maximize that. And one of the things that we're pretty excited about is we actually realigned our sales force. We expanded our targeting. We actually added 2,400 additional targets in Q2 of this year to actually maximize that opportunity. So our plan is to maximize the full asset, to continue to see stabilization in the opioid dependent indication, but also to fully maximize and grow alcohol dependence.
spk08: And then on the gross to net front, I think the premise for us as we came into 2021 was there was going to be a larger Medicaid population, and that's what really drove that 54% gross to net assumption that we made at the beginning of the year. What we're finding is that while Medicaid is growing, it's not growing by as much as we originally thought. So we have some favorable adjustments coming through in the first two quarters, as a result of which, as you noted, we're reducing our expectation for the remainder of the year to the 52.5%. I mean, one of the things with gross to net is the information that comes in from the states is always lagged by six to nine months, so the data's been a little bit choppy. So we're not 100% sure as to what the future looks like. But obviously it's something we're monitoring very closely and will provide, you know, guidance for 2022 when we go out with year-end earnings in February. Thank you.
spk03: Thanks, Gene. Thank you. Ladies and gentlemen, we have no further questions. This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.
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