Alkermes Plc

NASDAQ:ALKS

Earnings Call Transcript 2021-Q2

[Operator]

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. [Operator Instructions] Please note that this conference is being recorded.

I will now hand the call over to Sandra Coombs, Vice President of Investor Relations. Sandy, you may begin.

[Sandra Coombs, Co-Head, IR]

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; Iain Brown, our Chief Financial Officer; and Todd Nichols, our Chief Commercial Officer.

Before we begin, I encourage everyone to go to the Investors section of alkermes.com to find our press release and related financial tables, including a reconciliation of the GAAP to non-GAAP 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 2 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.

[Richard Pops, Chairman & CEO]

That's great. Thank you, Sandy. Good morning, everyone. We had a strong second quarter and 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 , ARISTADA, 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 reported robust non-GAAP net income for the second quarter and we are increasing our guidance for the year.

The FDA approval of LYBALVI represents another meaningful growth opportunity for the company and the value of the pipeline has also become more evident with nemvaleukin advancing and other candidates progressing as plan.

Current revenues, emerging revenue streams and 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 want to talk a little bit on LYBALVI. Our first approved oral antipsychotic. LYBALVI will leverage our commercial infrastructure and represents our next revenue growth opportunity. LYBALVI 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 LYBALVI’s features.

We believe we’ll be able to differentiate this medicine in a large market based on its clear attributes in a simple message, LYBALVI captures the established efficacy of olanzapine with less weight gains. We’ve been establishing our commercial capabilities and presence in the schizophrenia market for five years with ARISTADA, 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 LYBALVI 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 LYBALVI into 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. LYBALVI 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 us to develop the medicine 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 LYBALVI reflects this focus.

I think we can tell a similar story about nemvaleukin. Nemvaleukin 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 3 study in platinum-resistant ovarian cancer, secure FDA orphan drug designation for mucosal melanoma and work 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 we are joined by the lead investigators for both ARTISTRY-1 and ARTISTRY-2 studies, who shared their clinical perspectives and experience with nemvaleukin. That presentation is on our website. If you haven’t seen it, I recommend taking a few minutes to watch and give you sense of the current status of the program and the significant progress that we’ve made.

Nemvaleukin is accumulating a clinical dataset 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 Polish checkpoint inhibitor setting.

The study is 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 are moving ahead now with momentum and look forward to sharing our progress across the program with you.

So, before I conclude, I am going to take a moment to acknowledge the efforts of our talented and dedicated employees who have remained focused and committed to the patients we serve over the past 18 months despite the challenges in 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 LYBALVI the accumulating data and the operational progress across the nemvaleukin development program, all of these provide a strong foundation for growth and execution for the balance of the year.

I am going to turn it over now to Todd and Iain to take you through the Q2 results and our improved financial expectations for the year. Todd?

[Todd Nichols, SVP & Chief Commercial Officer]

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 ARISTADA 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 to current trends in the treatment landscape will continue, we are raising the bottom-end of our full year net sales expectation ranges for both ARISTADA and VIVITROL. Iain 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 and the treatment option for alcohol-dependence among providers, caregivers and patients.

A recent market research show that 80% of healthcare provider’s survey 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 in 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 impart driven by pandemic-related disruptions that persists 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 ARISTADA 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 outpaces the broader long-acting, atypical, antipsychotic market growth of 5%.

We have continued to see positive recovery trends in the long-acting antipsychotic market in recent months. Healthcare providers reported an increase in patient visits as offices reopen. 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 healthcare providers in both the addiction and LAA 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 and local conditions carefully, as potential new COVID-19 hotspots arise and we’ll make adjustments to our commercial strategy if necessary.

I’ll end with an update on our launch activities for LYBALVI, our new oral, antipsychotic agent. During the second quarter, the FDA approved LYBALVI for the treatment of adults with schizophrenia and the treatment of adults with Bipolar-I disorder. We are pleased with the approval label which includes data showing that treatment with LYBALVI was associated with less weight gain than treatment with olanzapine and proven antipsychotic efficacy.

Additional feedback on our 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 LYBALVI will join ARISTADA 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. ACP awareness of LYBALVI has been steadily increasing over time and we believe we are well-positioned for launch.

Hiring is underway for our open sales force positions and we are impressed by the caliber of talent that LYBALVI launch is attracting. With the label now in hand, we submitted our promotion 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 finalize 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 LYBALVI is reflected in the label providing meaningful opportunity in the oral antipsychotic space. As the country continues to reopen and the frequency of in-person promotional activities increasing, 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 LYBALVI, work to achieve our expectations for VIVITROL and ARISTADA and continue to drive awareness of the value proposition of these important medicines.

Now I will turn the call over to Iain to review our second quarter results and our updated financial expectations for 2021.

[Iain Brown, Senior VP & CFO]

Thank you, Todd, and hello everybody. We are 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 are 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.

The strong revenue growth, combined with our continued focus on disciplined operating expense management drove a GAAP net income of $2.4 million and a non-GAAP 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.

G2 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 are raising the bottom-end of our 2021 expectations of VIVITROL net sales by $16 million from a range of $315 million to $345 million to a range of $330 million 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 increased during the quarter by approximately $6 million as the number of key customers adjusted their inventory to support the growing demand.

Based on the current trends outlined by Todd, we are 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 million to $290 million to a range of $275 million 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 SUSTENNA 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 LYBALVI.

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 younger nemvaleukin clinical studies and the initiation of the ARTISTRY-6 Phase 2 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 investments to support the approaching launch of LYBALVI.

As we continue to lay the foundation to achieve the profitability targets that we set forth for 2023 and 2024, we are 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 the 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 billion 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 are also adjusting the ranges for certain operating expense line items, with changes at 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 LYBALVI.

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 GAAP net loss has improved by $30 million and our expectation for non-GAAP net income increased by $20 million to a new range of $85 million to $115 million.

Looking ahead, we are focused on driving continued growth of our proprietary commercial portfolio and capturing operating leverage as we launch LYBALVI, while at the same time, advancing the nemvaleukin 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.

[Richard Pops, Chairman & CEO]

Great. Thank you, Iain. I’ll finish briefly. I’ll just say, looking ahead, I am encouraged by the outlook for the business. VIVITROL, ARISTADA, LYBALVI 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 bespoke and efficient set of capabilities designed specifically to maximize the medical and economic value of this singular medicine aid to the market.

ARISTADA and LYBALVI are synergistic and provide significant opportunity to drive operating leverage with our purpose-built psychiatry infrastructure. VUMERITY is growing and our commercial partnership with Biogen delivers pretax profit directly to the bottom-line. Together, the revenues from the 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 pipeline. 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.

Nemvaleukin is most prominent and advanced asset in the pipeline, but we are equally excited about our earlier stage program. I look forward to sharing updates from our HDAC, Orexin in the engineered cytokine portfolios as they advance towards the clinic.

With an intense focus on business excellence, financial discipline, and effective capital allocation, we believe we are 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.

[Sandra Coombs, Co-Head, IR]

Okay. Thanks, Rich. Alex, we'll open the call for Q&A now.

[Operator]

[Operator Instructions] Our first question comes from Vamil Divan with Mizuho Securities. Please proceed with your question.

[Vamil Divan, Mizuho Securities]

Hi. Great. Thanks for taking my questions. So maybe if I could just ask two. So, one on VIVITROL. I heard the comments you made around the sort of dynamics in the alcohol versus opioid market. Can you maybe just quantify performance this quarter, just give us a sense of how much of it’s coming from alcohol versus opioid? There maybe even on top plus, so looking forward I expect a growth between the two to differ.

And then the other one would just be on nemvaleukin and the sort of the update you guys had at ASCO. If you can just sort of comment on what we can expect from that product in terms of data in the second half of the year whether and lower to see otherwise in any updates you may have in terms of the collaboration. Just assume that you’d be having with larger partners for that product. Thank you.

[Richard Pops, Chairman & CEO]

Good. Okay. I’ll start off with VIVITROL. The visibility that we have is to claims data into – and also our own hubs reported data. It’s a little bit lagging. Our belief from 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 are encouraged by that.

One of the areas that we are encouraged and is really looking at diagnosed patients. When you look at the diagnosis right now, quarter-over-quarter we are 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% in VIVITROL NBRxs are up about 10% quarter-over-quarter. So, again, we believe it’s about a 50:50 split right. 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 in alcohol dependence is growing. So we are expecting that to continue into the back half of the year.

[Todd Nichols, SVP & Chief Commercial Officer]

And Vamil, maybe I’ll take the first part of – the second part of your question and have Sandy give you the update on data. So, the important part about the ASCO presentation, just to summarize is that, I think the real differentiation of nemvaleukin 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 differencing feature was its clinical data where we are 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 in the serious unmet needs as evidenced at the beginning by mucous melanoma and platinum-resistant ovarian cancer.

So, all of this together provides the foundation for our – advancing these discussions with potential partners because, partnering nemvaleukin remains a centerpiece of the strategy because of its potential utilization from different categories and different combinations and different tumor types. So, I won’t comment on the specific discussions on it. We just know that that’s something that’s an intense focus within the company and we’ll update you as we make progress.

[Sandra Coombs, Co-Head, IR]

Okay. And in terms of data proof in nemvaleukin, we did provide a very 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 forms to present those data at – in the future. We’ll intend to have it presented at ESMO but it’s premature to commit to which datasets will highlighted at this meeting.

[Vamil Divan, Mizuho Securities]

Okay. Thank you.

[Operator]

Thank you. Our next question comes from Cory Kasimov with JPMorgan. Please proceed with your question.

[Cory Kasimov, JPMorgan Chase & Co.]

Hey. Good morning, guys. Thanks for taking my questions. I have two from 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. But longer term, has your thinking of all tier – and what – and how you are looking at the relative contributions 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 got the lower anticipated guide ahead of the LYBALVI launch. It’s not a law, but it’s not also typical in a situation like this. So, is it just the function of some of that spend being pushed into 2022 or more about leveraging ARISTADA or is there something else there that I am missing? Thank you.

[Todd Nichols, SVP & Chief Commercial Officer]

Thanks. Good morning, Cory. I’ll take the first question on VIVITROL and how we are thinking about it. At Alkermes, we’ve always had a focus on alcohol and also opioid. We worked on it on the evolution of our strategy for the last 12 months or so. And we really believe that there is 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 is 14 million patients that actually have a diagnosis of AUD, but there is 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 are seeing an increase in alcohol dependence with origination levels that are very strong at this point. We also asking very consistently the review on medication.

70% of physicians report to us that they believe in medication is important. So our opportunity is really to build awareness in the patient community right now around medication and not just a stigma, because this is a medical condition as well. When we look overall, the overall dynamics of the business at a sub-national level, we are 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 is an opportunity long-term to drive awareness and to drive a greater penetration for patients that suffer from this disease and we believe that VIVITROL can play a big part in that.

[Iain Brown, Senior VP & CFO]

And then, Cory, 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 onboard which we are obviously very happy with. The focus is very much to leverage the existing infrastructure that we have for ARISTADA.

And I think, as you look at the timing of spend, we’ll increase investments into Q3 and then there will 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.

[Cory Kasimov, JPMorgan Chase & Co.]

Great. Thank you very much.

[Operator]

Thank you. Our next question comes from Brandon Folkes with Cantor Fitzgerald. Please proceed with your question.

[Brandon Folkes, Cantor Fitzgerald]

Hi. Thanks for taking my questions and congratulations on a very good quarter. I just want to drill down on the VIVITROL opioid headwinds you called out. Can you just elaborate how these headwinds we are seeing at the moment compared to your expectations maybe at the beginning of the year? Are we seeing improving trends a little bit worst? Any color there.

And then, if you can just elaborate obviously, we are seeing opioid just go unfortunately the wrong way. And so, are these headwinds really just coming from patients to monitoring into a facility or is this funding gap at states as they – COVID, just any color in terms of how you might see these headwinds in opioid base progressing? Thank you.

[Todd Nichols, SVP & Chief Commercial Officer]

Yes. Absolutely. Brandon, first and foremost, there is no gaps in funding 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 fund release. But we don’t have visibility as we said in the past that state level grants that are available,

But we know there is a significant amount of funding that is available and our belief is that eventually that will trickle down at the sub-national level and we use for Amity programs and programs such as VIVITROL. So, we are 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 are 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 that patients had access to treatment overall.

We are 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, union health services, and so forth.

I would say, in Q2, we are starting to see some encouraging trends there. On a quarter-over-quarter basis, we are seeing growth in those segments. But still not back to the levels that we would expect that from 2019. So, the headwinds mainly that we are seeing with an 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.

[Brandon Folkes, Cantor Fitzgerald]

Very helpful. Thank you.

[Sandra Coombs, Co-Head, IR]

Thanks, Brandon.

[Operator]

Thank you. Our next question comes from Paul Matteis with Stifel. Please proceed with your question.

[Paul Matteis, Stifel]

Great. Thanks for taking my questions and congrats on the quarter. For LYBALVI, I was wondering if you could kind of layout 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 that it’s 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 the realistic goal? Thanks so much.

[Todd Nichols, SVP & Chief Commercial Officer]

Yes. Absolutely. I’ll tell you, we are really excited about the launch of LYBALVI. As you heard Rich say , we actually are in the first phase of our launch right now, that started with the 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 are doing that with ATPs, but we are also doing it with payers right now, as well too.

And we are executing engagement plans with payers in sharing the clinical profile. Payers are most interested in our clinical profile at this point. That was our expectation, our medical team is out sharing the clinical profile. We 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 is three key segments of the business, Medicaid, Medicare and commercial. They are 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 in different timelines. For Medicaid, it’s a state-by-state plan. 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 when it’s commercial that you are going to see quite a bit of indices blocks at launch. These payer restrictions and that’s not uncommon outside of just this category and our belief is that will be anywhere from six to nine months.

So, the way that we are thinking about this is, we are going to have access programs at launch. PA support benefits investigation, co-pay programs at launch, sampling programs at launch to help support access to the product, to help support trial in the usage at launch and the profile for access will really evolve over the first 12 to 18 months.

[Richard Pops, Chairman & CEO]

Do you want to comment on the step-through?

[Todd Nichols, SVP & Chief Commercial Officer]

That’s right. Yes. The question on step-through. We are – the feedback that we received from payers is that, LYBALVI will be treated similar to another branded agent. So it’s very common in the marketplace to have PAs prioritization step-throughs. It could be one step-through. One step at it, two step at it. There is the potential to have a step at it through olanzapine. So, we are prepared for that with the programs that we have in place.

[Paul Matteis, Stifel]

Great. Thanks very much.

[Todd Nichols, SVP & Chief Commercial Officer]

Okay.

[Operator]

Thank you. Our next question comes from Umer Raffat with Evercore. Please proceed with your question.

[Unidentified Analyst]

Hi. This is [Indiscernible] here speaking for Umer. Thanks for taking the time for our question. Just to follow-up on LYBALVI, consensus is modeling about $70 million to $80 million of sales for fiscal year 2022. How are you thinking about those numbers relative to your learnings from recent antipsychotic launches?

And separately, a different question on VUMERITY. Could you clarify your policies on royalty rates and revenue recognition? We know there is nominal rates about 15%. But today’s numbers imply about 20% of Biogen’s reported net sales, any detail you could give there?

[Richard Pops, Chairman & CEO]

So, this is Rick. Why don’t I start on the LYBALVI question. Obviously, we are not ready to give guidance for 2022 yet. But I do think recent launches indicate a couple of things about the gradualness of the – 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 are actually funding our launch sequentially as access grows across the nation, we can then dedicate more marketing and personnel resources to the launch of the product. So I think, from our view, is that you can hold these two thoughts simultaneously and that is, A, that the launch can be gradual and B, see open that market potential can be substantial. But these are not square wave launches in those different aspects of the business.

Iain, do you want to comment on the VUMERITY?

[Iain Brown, Senior VP & CFO]

Sure. On the VUMERITY question, we have two sources of revenue for VUMERITY. 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 it by 15%, that’s our royalty. The other element is we do manufacture the products for Biogen, as well on a cost plus basis. So that difference is really the manufacturing revenue that we earned in the period.

[Sandra Coombs, Co-Head, IR]

And I’ll just add one comment to Rich’s LYBALVI comments and that’s not all of the models that we have seen has been updated to reflect the Q4 launch timing. So some of those models are going to get pushed out of the world that I would expect that number to come down a bit.

[Unidentified Analyst]

Got you. Thank you.

[Operator]

Thank you. Our next question comes from Marc Goodman with SVB Leerink. Please proceed with your question.

[Marc Goodman, SVB Leerink]

Hey. Good morning. Rich, I was wondering if you can give us an update on the original strategic review with respect to how you are thinking about partnerships. How you are thinking about the divestitures. How you are thinking about your original margin goals that you laid out for us at that time? Thanks.

[Richard Pops, Chairman & CEO]

Yes. And I am happy to, Marc. Obviously, the margin goals are a lot easy to achieve when you have the royalties – I am sorry, when the revenue line is looking as robust as it is. That’s why it’s so important I emphasize today resumption growth in VIVITROL, ARISTADA, VUMERITY, and now with the turning on this for LYBALVI. We have the top-line looks like it’s going to be 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 Iain has spent a lot of time focusing on that tuning that, so that we will be able to hit those profitability targets. Central to that is this idea of partnering nemvaleukin both from a finance perspective to offset certain R&D expenses associated with it.

This is 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.

[Marc Goodman, SVB Leerink]

Are we into things for 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?

[Richard Pops, Chairman & CEO]

Yes. I am not going to put a timeline on that for obvious reasons, but they are important for us to do and it’s also important for us to do it in the right configuration with the right partner. This would be hopefully a long-term relationship that’s going to have the substantial strategic value to the company. So, we are going to make sure we do it correctly.

[Marc Goodman, SVB Leerink]

Okay. Thanks.

[Sandra Coombs, Co-Head, IR]

Thanks, Marc.

[Richard Pops, Chairman & CEO]

But the only thing – the color I’ll give you, Marc, is that, what is the tailwind for partnering of data and that’s what’s - that was so important at 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 pre-requisite for serious partnering discussions. So, we are encouraged by the way that that dataset is building and I think that’s going to continue to help us.

[Marc Goodman, SVB Leerink]

Thanks.

[Operator]

Thank you. Our next question comes from Terence Flynn with Goldman Sachs. Please proceed with your question.

[Unidentified Analyst]

Hey. Good morning, this is Matt on for Terence. Thanks for taking our question. With regards to the nemvaleukin partnership, could you just talk about what you view as some ideal structure for such a partnership? And then, also in terms of monetizing any non-core assets, what will be your focus for cash?

[Richard Pops, Chairman & CEO]

Yes. I think that the features of the nemvaleukin partnership are a couple principal ones. One is with the partner our counterparty that’s a strong oncology developer or someone who just augment our development capabilities substantially. Number two is, obviously, offsetting significant amounts in the R&D spend.

But that’s associated with number three, which is broadening the indications that we are going after for nemvaleukin. We have intentionally after a period of time in the clinic of signal exploration, we’ve count 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 that we get indications from all clinicians regularly now looking for additional combinations, different places to go and 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 are the important features for us to consider.

[Unidentified Analyst]

Got it. Thanks.

[Operator]

Thank you. Our next question comes from Kelly Shi with Jefferies. Please proceed with your question.

[Unidentified Analyst]

Hi, good morning. This is Jason [Indiscernible] on for Kelly Shi. And you may have just addressed my question. But we are wondering just for nemvaleukin besides melanoma and ovarian cancer, what do you think there are some of the other most promising indications based on efficacy? And then, which ones do you think are the most promising to move to the next phase? And the clinical bar on regulator bar for the melanoma registrational trial, thanks.

[Richard Pops, Chairman & CEO]

Yes. I think in general, in the nemvaleukin program, we are really interested in this white space, where patients are being treated, where checkpoint inhibitors have not shown robust efficacy or post-checkpoint inhibitor failure. That’s both in combination with the checkpoint inhibitor like Pembro, but also potentially in other combinations.

You saw us present some data at the Investor Day and we’ve 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 in different combinations, as well as different tumor types, but again, I think our preference at this point is rather than looking at tumor types, where we are looking for nemvaleukin plus the 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.

[Sandra Coombs, Co-Head, IR]

The clinical buy for ARTISTRY-6 and ARTISTRY-7 what kind of response rates are we looking for. Yes, we haven’t disclosed the study design details for ARTISTRY-7 yet or provided details on that. But that will be a forthcoming one as we initiate that study. For ARTISTRY-6, in melanoma, this is intended to support potential registration in mucosal melanoma which is really underserved and has high unmet need.

So, there is not a lot of treatment options that these patients have left. We haven’t provided a specific ORR or the durability of response rates that we are looking for. We will really look at it as a holistic dataset and review that with the agency to support potential approval once we have the data from that study.

[Richard Pops, Chairman & CEO]

Yes. I think it’s important point we tend to make, because it’s not just an overall numerical response rate. One of the promises of IL-2 therapy of course is the durability of these responses. So it’s a combination of response rate and the durability of the responses it will provide the overall profile of the medicine that could support registration.

[Unidentified Analyst]

Great. Thank you. Very useful.

[Sandra Coombs, Co-Head, IR]

Alright. Thanks, Jason.

[Operator]

Thank you. Our final question comes from Jason Gerberry with Bank of America. Please proceed with your question.

[Unidentified Analyst]

Hi. This is Chi, on for Jason. Thanks for squeezing me in. I would like to go back to the – thanks for all the colors that you have provided regarding the opioid and the alcohol contributions. But curious on a net basis, it looks like, Q2 sales was pretty similar to 2Q 2019 level. So, on a net basis, do you feel like you are back to pre-COVID levels in terms of how the franchise is operating?

I was just curious, as we look ahead to 2022, do you – how should we think about the franchise to grow the – should we look at 2021 as a base year? Or do you expect an searching demand if things at the whole haven’t quite fully materialized yet – normalized yet. I guess, do you expect opioid to pick up where the tailwind for alcohol maybe moderating as COVID subside against that’s really a question.

How should we think about the gross to net adjustment for the trial? Do you have VUMERTY growth expectation for full year by about 250 basis points? Should we think about the 50% to 25% as a go forward basis or should we think about more in the 50% range as the go forward basis, just maybe also goes back to the contribution of the opioid and alcohol dependency plus any color you can provide that will be great. Thanks.

[Richard Pops, Chairman & CEO]

Yes. I’ll start first with the comparisons of what we are looking at. We are taking a sharp look at performance relative to 2020, but we are also really looking hard at 2019 the performance that the brand contributed in 2019. Our belief based upon our market research and what we are 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 are going to continue to see stronger market growth for the alcohol dependence market which we are seeing. We are expecting that to grow at approximately 15% this year. We are expecting the opioid market to grow at approximately 7%. And so, we are adjusting our strategy – our commercial strategy to maximize that. And one of the things that we are pretty excited about is, we actually realigned our sales force.

We expanded our targeting. We actually added 24,00 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.

[Todd Nichols, SVP & Chief Commercial Officer]

And then, on the gross to net fronts, 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 are 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 are reducing our expectation for the remainder of the year to the 52.5%. I mean, one of the things at gross to net is the information that comes in from the states is always lagged by six to nine months.

So the data seems a little bit choppy. So we are not a 100% sure as to what the future looks like. But obviously, it’s something we are monitoring very closely. And we’ll provide guidance for 2022 when we go out with the yearend earnings in February.

[Unidentified Analyst]

Thank you.

[Sandra Coombs, Co-Head, IR]

Thanks, Chi.

[Operator]

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.