Alkermes plc (ALKS) Earnings Call Transcript & Summary

Good morning, everybody. Thank you for joining us. I'm Terence Flynn, the Biopharma Analyst at Goldman Sachs. We're very pleased to have Alkermes joining us this morning for our virtual conference. From the company, we have Richard Pops, Chairman and CEO; and Sandy Coombs, Vice President of Investor Relations. Thank you both for taking time this morning to be with us. Really appreciate it. And first, I'm going to turn it over to Rich for some opening remarks before we go into the fireside chat.

Well, good morning, Terence, and good morning, everybody. I won't take long. I'll just say a couple of things that are top of mind for me. One is, at this moment in time, which is this interesting confluence of COVID-19, along with significant civil unrest under -- over about racial disparities in the U.S. It's a moment to remind the world the importance of the biopharmaceutical industry. And in our particular case, in Alkermes case and our particular value that we bring to the society by the work that we do, the -- in the aftermath or in the midst of COVID and the principal sequela driven by COVID, other than the virus itself, are going to be the serious mental illness and addiction liabilities that are engendered by isolation and fear and economic hardship, and this is where our company lives. The other thing is that a lot of focus now on the criminal justice system and injustices in the criminal justice system, and we have been living in that also for the last several years. We never expected to be there. We thought we would just make medicines, but we learned about tremendous amount of injustice in the criminal justice system and incarceration of people for nonviolent offenses largely related to substance abuse and serious mental illness. And so it just underscores the goodness of what we do, the importance of what we do. I think we -- our company administered our own proprietary medicines to over 150,000 people last year. These are not orphan diseases. These are significant public health issues, and we're making a real impact. And we're really proud of that. So I just want to start with that. and the other thing I'll start with, Terence, is that this is -- I wish we were all in person, but it is another investor conference I will make forward-looking statements. We always ask you to take a look at our risk factors that we disclosed in our SEC filings because we do face a lot of different risks. And -- but let's carry on from there. And I would say that the basic configuration in the business right now is stabilized now. When we did our Q1 earnings call, it was right in the smack and middle of the maximum uncertainty in our commercial world, which I just referred to, serious mental illness and addiction with social distancing, they're a bit of a double whammy. Patients didn't want to go to the doctors, and doctors didn't want to see these patients, by and large. So we saw an immediate impact in our VIVITROL business, it was pretty significant, about 25%. That appears to have stayed, but we've seemed to have moved past the nadir now. As the country reopens, things are coming slowly back to normal, but also it revealed that the demand for these types of medicines didn't go away, or the need for the patients, it's not like a restaurant or a hotel where the customers disappear. There's significant need for our medicines. And so I feel like we've passed the nadir, the business has stabilized. ARISTADA was never affected as much as VIVITROL. VIVITROL, we put the field force back out last week. And so we feel like we're powering back up in the year. We suspended our guidance based on the uncertainties after the earnings call, we gave a little bit more clarity more recently. I want to make sure people understand that we tend to manage the business to cash flow breakeven this year, non-GAAP breakeven this year by expense management and then also whatever we needed to do to do that. But it's encouraging at least now to see things starting to limber back up and business coming a bit more back to normal. With the caveat, of course, being there could be a second wave, there could be -- things eventuate that none of us can really predict right now. But what's clear to us throughout this all is that for VIVITROL and ARISTADA and soon to be 3831, the human need, the clinical need for these medicines is significant. I don't think that's going to dissipate. The other piece that we get questions from investors about is VUMERITY, which is -- we're quite excited about. Biogen is launching that drug. It had a pretty slow first quarter, a lot of switches in MS apparently didn't happen in Q1 and as the people didn't go to the doctor and as a result, there weren't a lot of switches in medicines. But we delivered to Biogen medicine that we think has really nice differentiation and a really excellent clinical profile and can meet a really important business and medical need for Biogen. So we're looking forward to that growing as well, and we're in the midst of our review for 3831, and we're looking forward to that drug getting approved hopefully and launching early next year. So the basic elements of the business are in place. And I'd say the wildcard still for most people who don't have access to perfect information is 4230. It's an oncology agent. We're not known for our work in oncology. I think we will be increasingly known for it, but it's moving nicely, and we actually continued to roll patients during the COVID shutdown and enrolling probably more patients than we ever have over the last 2 or 3 months. And I think that, that's shaping up to really nice data readouts at the -- toward the end of the year for that as well. So maybe with those as opening comments, I'll let you run the show.

Great. Well, now thanks for your comments, Rich, and thanks for all the work that you guys are doing on the health care front. I guess one, you touched on this a little bit in your prior remarks is just as we think about the impacts that COVID could have on the health care system, both kind of a near-term basis, longer term in terms of your business model and strategy. Anything you could expand on there as we think about kind of some of the lasting impacts that this could have in terms of kind of how you're going to adopt to the new environment because I think, again, we all assume there's going to be a new normal after we come out the other side of this.

Yes, there's some pros and some cons. And so anybody tells you this is all fine, he's not telling you the truth. But there are some silver linings in here that are quite interesting. So on the negative side, we make injectable medicines, and we make injectable medicines that are not patient self-administered. These are deep intramuscular injections administered by health care providers. So if people are scared to go to the doctor or if doctors are afraid to see their patients, our medicines get impacted more than other medicines that may be fulfilled by a prescription via mail, for example. So that's a challenge. So how do we adapt? How do we and how does the whole ecosystem adapt? Well, the use of remote interactions with caregivers both by patients and by our representatives is burgeoning right now. Telemedicine, as a general phenomenon in the wake of COVID, is going to get winded in sales. Telemedicine psychiatry, in particular because there are many rural counties in America where there isn't even a single psychiatrist. Telemedicine for psychiatry is the future. We are disseminating for better care for patients. And we view that the combination of long-acting injectables as a foundation for telemedicine is a very powerful combination. Because then in our interaction we're having right now via Skype or Webex, I don't have to worry about whether you're taking your medicine every day. That's sorted. That's settled. What we can deal with is the behavioral counseling piece via telemedicine. And so that's why less frequent interactions with caregivers is consistent with this idea of social distancing and still delivering state-of-the-art care. So we're really invested at the policy level and operational in trying to understand telemedicine in psychiatry coming out of COVID. I guess the other thing is that, you've probably heard me say, I think that the universe burns a lot of energy having sales representatives driving in cars, hours a day for 15-minute meetings with doctors who really don't want them in their office. So the idea of a remote detailing, we're seeing receptivity from the clinician's point of view, it can save their time, but also it can save our time so -- and change the cost structure. So I think that the pharmaceutical rep of the future, and I don't mean the distant future, I mean the fall, has got to be somebody who can deal with in-person interactions as well as absolute function in ways when in-person interactions are not available to them.

Yes. Okay. Great. Maybe the other topic is -- and you touched on this a little bit, it sounds like you're past the nadir here in terms of the business and the country is reopening. But as you think about the question on guidance, that's what we get from folks more recently, is, is there an opportunity to kind of reassess that on the second quarter call? Or do you think, given the uncertainty around a potential second wave of infections in the fall time frame, you're likely to kind of maintain kind of current status, which is no guidance because of the uncertainty, how do you think about the guidance question?

Well our strong preference would be to reestablish guidance at the Q2 call. But we'll only do so if we can do so with some amount of certainty because we've done the experiment of missing guidance, which isn't really fun. So the Street loves to have guidance because it makes their job easier. And we like to have guidance because it makes our interactions with you much more easy. But we also want to make sure that we have some precision around it. So we're modeling this stuff literally week-by-week, forecasting and reforecasting. And if we feel like we're in position to get at least a certain cone of certainty that we can give, we'll try to do that. But I can't commit to it right now.

Okay. What any other variables you're watching in particular? I mean, I'm guessing it's going to be the, kind of, infections, you're watching, probably, your weekly shipping data, your physician rep interactions. But what data are you kind of using to rate that?

The most important leading indicator for us is actually our ability of our representatives to get in front of their customers and are the customers themselves seeing patients. We -- there was an alarming trend back when we suspended guidance, we saw an alarming trend of certain treatment centers switching people from VIVITROL to oral naltrexone because, say, here's a prescription, go to the pharmacy and get it. That is dissipated. We're not seeing that as much in remote. But if patients aren't getting access to their caregivers, that's going to affect our medicines. So the indicator is are patients able to get into the treatment centers and get their visits and get their medicines. You saw that we are putting in new capabilities across the country with Albertsons and other types, too. And this is consistent with the whole idea of telemedicine as well, finding other places, nontraditional places to get your injection. If you only need an injection once a month, once every 2 months in the case of ARISTADA, making that easily available in the community disassociated from your actual behavioral health counseling is a good idea. So that's where we're working on.

Yes. Okay. And VIVITROL, you mentioned this. That was one of my questions is I know April, your shipments were 25% wider than your pre-COVID expectations, sounds like the reps are now back out there. You have the Albertsons partnership. Any early read on kind of how that's been going? Is that helping to offset some of that? Again, it sounds like the trends are reversing, but any more color on kind of how the Albertsons situation.

I would draw the curve as it was steeply declining, it's plateaued, and it's beginning to stabilize. And so the -- what we don't know is what that slope of recovery is going to look like. And we're living that real time. So that's just a...

Yes. Okay. And I guess the other driver that you guys have talked a lot about is trying to expand the geographic reach for VIVITROL in terms of your base of prescribers. And I know right now you're focused a lot and kind of your top 5 states represent just over 40% of sales. So how is -- what's the next kind of phase of growth look like? I mean, where do you think that next bolus will come from, what other states are at the leading edge. I recognize COVID has probably slowed some of that momentum. But as you look forward into kind of back half of this year, '21, where are you guys spending most of your efforts in terms of that next group of states?

Yes. The -- we have a really sophisticated state organization and the state work is driven both by the state themselves as a particular ecosystem as well as the federal funding that comes in over the top, and the federal funding has been the dominant funding source for these states to deal with the opioid crisis. The other point I want to make is that alcohol, there is excitement about growing use in alcohol, which is where VIVITROL started, the emphasis really became an opioid as the crisis really blossomed. But as a public health matter, alcohol is still actually a bigger socioeconomic phenomenon than opioids. So different states have different areas of emphasis. I'd say recently, Virginia, Indiana, Kentucky, California, Ohio, these are places where we have very active programs that are receiving funding and impetus for change. But it's always difficult to predict the rate in which these things are going to translate into commercial sales. But there's -- you can just feel that energy across different states now to begin to respond to the various addiction issues that they're facing.

Yes. And do you think alcohol could ultimately become as big of an indication as your current addiction sales base? Or is the magnitude of order smaller? Just trying to think about the sizing of that because I know you guys have been focused on that for a while, all the way back from the early days of VIVITROL, but maybe just help us think about the size of that opportunity?

It's interesting because alcohol is, as I said, it's a bigger problem. There is -- that easy nexus between opioid and alcohol was through the criminal justice system and the drug courts, DUI courts, for example, that you have frequent DUI offenders. And these people essentially keep committing vehicular homicide potentially. So there's a very close proximity on the criminal justice side, using alcohol. Alcohol, interestingly, also typically tends to be more of a commercial insured patient, which has a much different price point. As you know, our price point for Medicaid for VIVITROL is quite low. It's in the $600 range, whereas the WACC for VIVITROL is more like $1,200 or so. So it's -- the business mix is different. So the answer to the question is yes. I think it could be, over time, as important as opioids because I think from a public health point of view, it's every bit as important as opioids. But it really took the opioid crisis for us to get a footprint of doctors around the country using VIVITROL. When we launched for alcohol, nobody was using medicines for alcohol, nobody had any experience with VIVITROL, it's very tough to break through to start using injectable and pharmacotherapy for alcohol dependence when the standard of care was 12-step. Now there's a footprint of doctors around the country that use VIVITROL routinely. And as they feel comfortable using it, they feel comfortable using it. And so the data are growing in alcohol as well.

Yes. Okay. Great. May be we'll move on to ARISTADA. Again, curious, I know there were kind of different dynamics for each product and kind of the downturn to now probably the recovery as well. So anything in more detail that you can share on kind of the recovery from ARISTADA front? And then what are you seeing in terms of kind of new-to-brand scripts? And where do you think you can get over time on that front?

So ARISTADA is a product that we are really proud of. And I think ARISTADA is an example of a product that fits into the post-COVID environment incredibly well. It's particularly -- the product offering that we're focusing on in terms of our commercial presentation right now is the combination of INITIO plus 2 month. 6 injections a year allows the patient to maintain therapeutic concentrations of a really important antipsychotic that's well tolerated as well. So that's really -- we didn't see as much of a drop in ARISTADA. In fact, we think ARISTADA's positioning in the marketplace is going to only improve in the post-COVID environment. So we have -- we still have really strong expectations, and it provides a really nice platform then for our launching 3831 because we have offerings in schizophrenia now that I think are highly differentiated and really important for patients.

Yes. And what do you think you could get in terms of share like over time. I mean, how -- where do you think ARISTADA can reach in terms of market share? Or maybe what's a good analogue for us to look at as we think about where this product could ultimately kind of peak out?

It's hard to project. I mean, we've always had expectations for it to be several-hundred-million-dollar drug. There are really only just a few long-acting injectables in the market despite the compelling logic and data supporting their use. And there's really only 2 therapeutics that are the foundational LAIs. The risperidone, paliperidone side of the market, which is RISPERDAL CONSTA and INVEGA SUSTENNA, which were drugs that incorporate our technologies sold by J&J. And then on the aripiprazole side, there is one long-acting Abilify, and then there's ARISTADA. And ARISTADA has all of the features that were built into INVEGA SUSTENNA in terms of range of doses, range of durations, ease of use, prefilled syringes, all the simple things that make using the drug. So those are all built into ARISTADA. So we think it's a -- the category itself is big and continues to grow at double-digit rates. You can see the data. There's -- more patients should be among acting injectable antipsychotics. That is just -- it's always been the case. You've heard me say that for years. Now, that's -- it's being backed up by data. The growth rates have continued to be very, very healthy. You think how old this category is notionally, right? RISPERDAL CONSTA was approved in 2002 or 2003. And here we are 17 years later, still growing double digits. That's what's so different for investors about our product portfolio is that VIVITROL, it's 10 years into its launch, it's still growing, it still has this nonlinearity component potential to it, whereas ARISTADA has been in the market in a few years, and it's just now starting to get its reputation. And psychiatry is reluctant to change. And it takes time, but I think these are very good medicines, and I think they have a real place for the long term.

Yes. And you mentioned that ARISTADA was a nice platform to launch 3831. Obviously, you've spent a lot of time and effort getting this program to the finish line. So maybe just remind us why you're so excited about the profile here of 3831 and where this would fit in the treatment paradigm as you see it?

So 3831 is a combination of olanzapine and samidorphan. Samidorphan is a new molecular entity we develop. And we include it in the combination to mitigate the weight gains driven by olanzapine, which is significant. Olanzapine drives significant weight gain. And if you go into the market and talk to clinicians with experience with olanzapine, you will hear that loud and clear. In fact, olanzapine has not even indicated first-line for schizophrenia anymore because of its excessive weight gain and what emanates from that in terms of metabolic syndrome or obesity or diabetes or whatever. So there are a number of well tolerated antipsychotics out there. Our view is that what the market is looking for right now is efficacy. So what happens to these patients is all patients go on to generic medications, they have a range of experiences, but most -- all of them relapse frequently. And as they frequently relapse, the compelling clinical need is not for another well-tolerated agent, it's for more efficacy. And clozapine and olanzapine are considered to be the most effective of these agents. They're not used first-line because of their liabilities. Yet, still today, 20% of prescriptions in schizophrenia are for olanzapine. So we think that the weight mitigation effects that we've seen in the clinic that we repeated in 2 studies are real. And we think that when we go out and test this with clinicians, there's a lot of muscle memory out there for the use of olanzapine. And as I said, it's used in the acute phase all the time. People come in, in acute exacerbations of schizophrenia, get put on olanzapine in the inpatient setting, but that -- it's difficult to maintain them on olanzapine. So 3831, we think fits into this basic offering that Alkermes is giving, but I think we're offering an incredibly well-tolerated, highly efficacious LAI, the long-acting form. And now we are coming to the oral side of market with a very efficacious, well-tolerated oral as well. And there really isn't another drug like it. So then -- so the caveat would then be -- would be, this is schizophrenia and this is psychiatry. So these aren't square wave launches, you build in, and that's why having a presence in the field with ARISTADA is so foundational, literally because if you have to start from scratch, you put a whole new sales force and a whole new national accounts team, a whole new government payment team in place that launches, schizophrenia drug, there's a lot to do, but we're there. The other x factor is that we expect to get a bipolar indication as well. And for a lot of these major psychiatric drugs, it's the combination of the schizophrenia indication plus something else that allows it to be used by a wider range of doctors. And here, again, there's a fair amount of clinical -- there's a lot of clinical experience for the use of olanzapine in indications other than schizophrenia. So we're guardedly optimistic about this. And investors will say, "Well, it's a good generic market, and no one's going to give excess, payers are going to stop." But look, that's ARISTADA. Every schizophrenia patient has been on multiple generic medications before they ever see a branded medication, period. That's table stakes. You know that going in. And there would be no opportunity if all these patients were doing well, but that's the horrible bit is they're doing well. Patient outcomes are horrible. And so people are looking for new better approaches to treat these patients.

Right. What -- and I know you have the PDUFA date coming up in November. You've also talked about an AdCom panel. Maybe in terms of this kind of virtual environment, have you found that FDA very engaged, has anything been different? Do you think your interactions are on track and how to think about some of those requirements that have to happen in a virtual setting before a drug is approved?

So I can answer that both in terms of our experience on 3831 and also just industry-wide because I've been involved with the PDUFA negotiations for many cycles now, and we're actually preparing for PDUFA 7 negotiations, which kick off in the fall. So I've been interacting a fair amount with the FDA on this topic. And I would -- I can confirm what Janet and others have been saying publicly, which is the reviews seem to be moving along a pace without significant disruptions. The question mark continues to be around inspections. And so in our case, we're manufacturing this in our plant at Wilmington. It's been inspected by FDA before. So we expect to be able to have, essentially, a virtual inspection in that particular case. But so far, so good. I mean, I think that the interactions have been proceeding per the calendar and what FDA is learning, and they'll tell you is that they're learning remote work tactics as well that they think will actually carry on beyond COVID because they're generating some efficiencies as well. I'll give you a simple example, meetings, getting everybody to White Oak on airplanes in hotels versus what we're doing right now, It is a hell lot easier to pull people together for a Zoom meeting, it is to do one in person so, so far so good.

Yes. Do you think those will stay with us post-COVID? I mean, because to your point I mean it seems more efficient. And again, I mean, if it works out and there's no hiccups along the way, I mean, it seems like a much more efficient way and could that ultimately stream line some of these approval processes.

I absolutely -- I've been talking -- I just had a conversation with Peter Marks from CBER and Patrizia Cavazzoni, who runs CDER now and as Janet has been redeployed. And they're absolutely looking at best practices that they can carry over. We're going to build that in the PDUFA negotiation, too. We can facilitate that. I think FDA, from an operational perspective, is reluctant to bring everybody back into the facility. Because if there's another outbreak, their functionality is critical to the national public health, particularly right now, responding to COVID. So they can't have everybody getting sick. So they're going to continue to work remote, I think, for a significant period of time. So we should get used to it. I should say that maybe as a piece of update. We did have our mid-cycle meeting on 3831, and it went really smoothly in terms of the operational logistics of it. And we were encouraged because it's an interesting review because it involves what used to be called division of metabolism endocrine now is called diabetes, lipid disorders and obesity. But because psychiatry and that group are reviewing it, the application has the potential to be a precedent-setting-type application because they've never approved a drug that prevents the weight gain. There're extensive guidances for weight loss drugs, but there is no precedent for something that prevents weight gain, even though it's within the narrow context of olanzapine-induced weight gain. So we were encouraged to -- recognizing the mid-cycle review is just that. It's in the mid cycle. They noted no concerns regarding the antipsychotic efficacy of the drug or the bipolar indication and no significant safety concerns at the time. The focus and the outcome appears to be driven by that division of diabetes, lipid disorders and obesity. For this reason, they never approved a drug for the mitigation of weight gain. So I think they're going to be focused on the clinical meaningfulness of the weight data that we generated in the context of the Phase III study, which obviously, that's the foundation of the program, that's what we believe in. And if -- I think if you bring experts together talking about olanzapine-induced weight gain, the absence thereof will -- I think we expect to do just fine. But we have a little bit more insight now post the mid-cycle meeting.

It is one -- I mean, I know one of the other questions has been just how to think about the diabetes side of the equation. I know you guys did some work there, but is that something that you'd expect to be discussing at the AdCom or -- again, given your mid-cycle review meeting, you feel pretty good that you're in a good place on that front?

I think if I understand your question correctly that division, the diabetes, lipid disorders and obesity, is sitting in consultation with psychiatry. They're looking at what does it mean to mitigate weight gain in terms of its metabolic consequences and what that. So I think they're absolutely focused on that. But I think that in a way, if you look strictly at the data that were developed in the Phase III program, the co-primary endpoints of the weight study were a mean weight change as well as a categorical cut of patients who gained more than 10% of the body weight. So those are just 2 numbers. And what do those numbers mean? Like that's -- and so we've always said those numbers represent a certain shift in distribution, but they also are informed by the flatness of that weight-gain curve over time and how that flatness persists over time. So I think it's that holistic view of -- okay. We've never really -- FDA has never really looked at endpoints like that before. What do they mean? What's the clinical significance? How do you label them? So I think those are all reasonably -- I think it's with those reasonable questions.

Okay. And would you anticipate -- that's usually about, I think, 2 months before the PDUFA? So I think your PDUFA is November. So again, kind of like early fall time frame, is that reasonable in terms of when do you expect it? Or is it kind of up in the air because of the -- again, the COVID environment we're in?

It's an interesting question because they gave us a tentative date late like deep in October. That means that they're going to try to wait as long as possible for COVID things to settle down. So you can have the first meeting forward. They're just reserving the right not to have it. If they don't want it and they don't need it at the end of the review. So it's -- I'm just speculating. I don't know.

Yes. Okay. I know the other, obviously, important piece of work you guys are focused on is the commercial prep, and again, there's very unique environment right now and you guys mentioned on your first quarter call that you were taking -- looking at potentially multiple different options in terms of how to roll this out from a commercial perspective. So maybe you could just give us a little bit more detail on those different aspects and again, what this looks like in a world where there's still some uncertainty about kind of infection risk, et cetera, as we get into kind of the end of the year?

Well, we're anticipating a Q1 launch. So we -- so that's soon but also a million years from now given -- but the great advantage that we have is that we have reps in the field. We will have perfect information about accessibility as we move through the year. So when we talk about planning contingencies, we will either be able to launch the more distant remote access, or we'll be able to go in person. Probably the principal toggle then is when you would bring on the additional headcount to support a wider footprint of docs would be targeted for an oral medication. And we'll just assess that as we go through the year.

Okay. And maybe the last one, before we go on to the 4230, is just on the payer research front. Any latest information to share on that front? I know you mentioned, obviously, generic market come kind of after that. But is there any new data on the payer front that you could share?

No, we've been pretty consistent on this last few months. It's going to be viewed as what it is, branded antipsychotic. There are going to be step-throughs, generic medications that may or may not include generic olanzapine. We don't a strong clinical reason why you would make somebody step through generic olanzapine, but it almost doesn't matter because patients are going to -- they're not going to see a branded medication until they've failed oral medication. So our point is once a patient crosses that threshold where branded medication becomes available, we want to make sure that we can compete based on the efficacy differentiation. I think that's the hook for us.

Yes. Okay. And maybe just in the last 5 minutes here, I'd love to focus on 4230, you mentioned this was the wildcard in the story. Again, you guys haven't historically been known as a cancer company. So just remind us why are you so excited about 4230? Again, I think there's been a lot of focus on next-gen I-O targets, but what is it about this target and the data that you've -- really gives you confidence to continue to invest here in that asset?

Well the specific answer to your question, the reason we're continuing to invest is because we're seeing the results that we wanted to see. Early on, it was based on the hypothesis, which was IL-2 is a very effective immuno-oncology agent burdened by a real significant tolerability issue, but driving significant durable responses in renal cell carcinoma and in melanoma. So the idea that we and others have had is can you attenuate the side effects and capture that efficacy that's driven by expansion of CD8+ cells as well as NK cells. And there's been a number of different architectures that people have pursued to try to do this. And we've always thought that ours was extremely clean, this idea of using the alpha domain on to IL-2 confers specificity for the intermediate affinity receptor. It all makes sense. The molecular biology makes sense, the preclinical data made sense. And now, in the clinic, what we're seeing is pharmacodynamic responses that are consistent with high-dose IL-2 without the tolerability issues, and we're starting to see these -- the corresponding efficacy results. So our view of it, right now, is more a question of distance, rate and time. We just -- we need to get more patients with more evidence of efficacy because world is different than when IL-2 was approved, obviously. So we're testing this in combination with checkpoints, with KEYTRUDA in particular. And we're excited about the data we're seeing in historically nonresponsive KEYTRUDA tumor types. We're also testing it as monotherapy because we want to prove the point that it, as a single agent, has anti-tumor activity in and of itself because we feel like that's a foundational piece of the story. And the other piece, of course, Terence, is that we're administering it in the beginning. When we started the program, we were using a pretty cumbersome daily IV regimen, which was the IL-2 regimen because we wanted to compare apples to apples. We have subsequently moved to a subcu administration. And we're testing that both weekly and once every 3 weeks. And both of those regimens so far are showing promise. We're seeing pharmacodynamic responses in a dose-dependent fashion. We're seeing tolerability. So we hope to be in a position of declaring that recommended Phase II dose with subcu regimens this year as well as continuing to bolster the evidence of efficacy. And I think the aficionados are looking at data and beginning to understand it. People, I think, will be looking for us to do some type of collaboration on it next year because it's so -- it has so much potential applicability in multiple different combinations, not just IL I-O but in combination with classic chemotherapy, with target oncology agents, with radiotherapy, anything that's presenting antigen and driving immune response that could be accentuated by this foundational IL-2 type biology makes sense. So to realize if the commercial potential really is there, the medical potential is there, it will be most fully exploited in combination with somebody who's got even significant resources to do it. And we're not going to do that deal till the evidence -- till we know it's real. If it's real, then that deal should follow logically here on evidence.

So that next data update, that would be, again, sometime later this year. Would it be in a conference? Would it be in a press release? How are you guys thinking about data disclosure?

Well, I think we're certainly going to be preparing abstracts for the fall meetings for sure, those are in process now. And the way with these meetings, with their deadlines and them going digital, it's all a little bit fluid right now, but we really have a strong desire to get data out into the community in the second half of the year.

Got it. Great. Well, maybe just the last question I had is just on the business development front. I know you guys have been fairly active there recently. Is there more to do? Or you feel pretty good about kind of the state of your pipeline right now and where the things stand?

Both. I think that our stock price is too low right now for us to do anything that I feel like would require significant amounts of equity. The pipeline preclinically, is good. We have some internal assets that we've not disclosed that they are moving. But typically, historically, when markets get tough and choppy, that's when an opportunity presents itself to find development candidates, and we've got a strong development engine. So we're very focused on costs, we're very focused on making sure that we're spending money in a high-return configuration or setting. So we don't feel any compelling need to do something, but we're always out there looking. And the other point I always make in this case is that the commercial configuration we have, the commercial footprint we have is it's complicated, it's expensive. It's hard to sell medicines the way we sell medicines into Medicare Dual Eligibles, Medicaid, things like that. But it's an asset. And so putting more products into that infrastructure is a good idea. So we're always going to be looking for psychiatry type products or other products that fit into that infrastructure.

Great. Well, I think we're up on time now, Rich, but thank you so much for joining us. Really appreciate your time, and good luck over the next couple of months and stay safe.

Thank you to you, as well. Really appreciate it.

Thank you. Take care, everybody.

Thanks.