Indivior Pharmaceuticals, Inc. (INDV) Earnings Call Transcript & Summary

I'm delighted to be here with you all this afternoon with the Indivior team. We've got Mark Crossley, our CEO. We've got Ryan Preblick, CFO. We've also got the [ Tim Owens ] from IR team as well. So thank you all very much for your time this afternoon. Lots of questions, interesting kind of Q3, and we're getting a lot of incoming. So really good opportunity to have a discussion, which we're looking forward to. Perhaps, Mark, if I can hand over to you to give a brief introduction in terms of the highlights you wanted to have at Q3, and then we'll get straight into Q&A. And people on the line, if you do want to ask a question, probably the easiest thing is to either send me an e-mail at jvane-tempest@jefferies.com or Bloomberg IB message, and we'll make sure we can put that to management. So with that, Mark, over to you.

Sounds great, James. And listen, thanks for hosting the session. And good morning and good afternoon to everyone on the call today. Appreciate the continued interest in Indivior. Before we begin, I just -- I have to point out the legal side of things, which is that comments today may include forward-looking statements. Actual results may differ materially. We list some of the factors that may cause actual results to differ in our third quarter materials, which are available on indivior.com. So I think for me -- we just had our Q3 results, let me summarize a few bits that have come out from one-to-ones and from our engagement with the brokers. I think probably the first thing that came across was litigation as a topic where people were looking in just from a high level standpoint. I think we are pleased to settle the antitrust multi-district litigation with the resolution with the direct purchasers as the settlement was reached, you've seen in the third quarter that with those results was going concern language has been removed that came in, in July. So we're happy to have the certainty that the settlement provides for stakeholders. With regards to the remaining litigation, as indicated by the removal of the going concern, we believe it's manageable. You'll also have seen that we initiated a $100 million share buyback that we announced just this past Friday after our Board meeting. And we hope that, that continues to give confidence in the good remaining flexibility and that we expect to continue to generate strong cash flow moving forward off the backs of our medium-term profitable growth thesis that we shared last December. The buyback is also really pretty fulsomely aligned with our capital allocation strategy that we've been sharing over the last 3 years. It balances investment in the business, financial flexibility meeting our commitments as well as the potential for business development and/or capital returns. I think we got a demonstrated track record at the management and board level of delivering against that allocation. So where the shares are currently trading and it also offers an attractive return for shareholders with regards to the buyback itself. The second comment we've heard and again at a high level is with regards to SUBLOCADE momentum. And I do want to just start with that we remain extremely confident in our peak -- net revenue goal for SUBLOCADE of greater than $1.5 billion. We -- I continue to be pleased with SUBLOCADE's net revenue progression this year. At the midpoint of our 2023 guidance, we expect to deliver greater than 50% year-over-year growth and understand that some investors are concerned about the sequential net revenue growth. But we believe it's part of some seasonality that we've seen and observed over the last couple of years. And when you look -- while quarter-over-quarter in the third quarter, it may have dropped to 8%. Year-over-year, it's still at 55% growth. So that's seasonality is there, but the strong momentum continues. We believe the commercial investments that we're making in SUBLOCADE will pay off by providing access to SUBLOCADE for HCPs and patients who just previously weren't able to use SUBLOCADE due to the administrative burden in these small independent practices. And given that this was enabled by the recent change kind of from a macro sort of impact of removing DATA 2000. The incremental revenue that we see from this opportunity was not part of our initial greater than $1.5 billion peak net revenue guide. So this is incremental to the foundation we'd already built and the guidance we'd already given. And then lastly, what we haven't guided for next year, we do expect to have strong momentum exiting the year and entering for year-over-year -- strong year-over-year growth in SUBLOCADE. The third comment we've had from the Q3 results is margin expansion. And I think we continue to expect ultimately to show demonstrable operating leverage in our P&L that we committed do at last year's Capital Market. I think a great example of this is even after acquiring the Opiant business and the costs associated with that earlier this year, we still expect to generate year-over-year adjusted operating profit growth this year. And just as a reminder, with regards to Opiant, strategically, if it's squarely in our expertise, our disease space, it's financially attractive. But the acquisition came with some short-term sort of cost that came in without revenue of $40 million to $50 million of costs in 2023, represents about 400 basis points of adjusted operating margin at the midpoint of our 2023 net revenue guidance. So for me, the clarity here is on driving value via different vehicles. One is the base business, the margin expansion, which we would have had significant margin and the other is by bringing in assets, which drive value on a cash flow sort of basis. So very exciting there. And I think the last piece that we've kind of heard about a bit is that we kind of altered from our virtual sort of manufacturing strategy. And when -- and acquired a manufacturing site and just really at its essence, really simply put, we believe this is an extremely prudent move, and it's in the best interest of shareholders as we look to secure the long-term production of SUBLOCADE and it's greater than $1.5 billion peak net revenue. We expect to complete the tech transfer go-live in 2026. And when we have a full year of manufacturing in 2027, we expect savings of $20 million from production at that site. So not only does it provide BCP, but it is better and cheaper with having this site in-house with -- under our control. So just a quick kind of conclusion, major antitrust behind us, we believe the rest of the matters are manageable, great confidence in SUBLOCADE's trajectory towards our peak net revenue goal of greater than $1.5 billion, and we expect to demonstrate the inherent leverage in our operating model that absent the acquisition of Opiant this year, you would have seen that over 400 basis points of margin expansion. So with that, I'll hand over to James. I know he's got some questions, and I'm sure some questions will come in virtually.

Quite a few things for us to kind of unpack there. I guess start off let's talk a little bit about the MDL. You mentioned here that there's 3 main tranches. That's kind of behind the company now, which is a great step forward. But one of the questions we've kind of been get that is it doesn't seem to be at the end of it. Because I guess when you do look in the Q3 release, there does seem to be some other new plaintiffs or whether losses cannot be estimated. And so can you help us sort of understand essentially what's left? And can you help us essentially understand what the settlement of that means?

And I think the key here is we're trying to control the controllables we can and bringing resolution on these things, certainly, the right value and bringing the antitrust classes, the states, the end payers that were the certified class as well as the direct purchasers to conclusion, we think is in the best interest of the shareholders, it also removes that going concern issue. Now there are some counterparties that have strategically gone and broken off from the class. We do have some end payers there. And probably the other one that's mentioned the most from a legacy issue is our inclusion in the opioid pain sort of MDL and we recognize that those are there. Those aren't at conclusion yet, but these are long-term legacy issues that we're continuing to actively manage to bring to conclusion. Obviously, the end payers, [ are -- is ] carved-out of a class that we settled for about $30 million. And while we can't guide to that. We know that the end payers do have some issues with their damages model. The film was cheaper during the time it's out there. So we don't have provisions against each of these because, again, we just don't see from a legal standpoint, the merits in the counterparty's case or potentially any sort of damages sort of model. So we continue to believe these are manageable. We'll look to actively manage them to bring them conclusion and provide certainty for shareholders.

Sorry to push, but I guess just to make sure I understand that you said it's a subset of the class of $30 million. So would -- again, it's not a guidance but a reasonable assumption to be what's kind of left is less than $30 million. I think where, I guess, a lot of the discussions I've had investors have been is you've made such good progress settling 3 MDLs, but in terms of what's left, simplistically, people are trying to understand if that's $1 million, $10 million, $100 million to $300 million. I mean literally because it's sort of where losses are unable to be estimated, any kind of kind of directional stair would just kind of be useful on the best efforts basis, even if there's no kind of specific guidance. I appreciate that might be what you can say, but that's kind of one of the main areas you'll be getting some feedback.

Yes. And I respect the question. I think all we can do is we've provided Note 13, which is very robust and its disclosures have provided a bit of context and perspective. But I think the key here is for us to focus on bringing these to resolution moving forward. And unfortunately, we can't provide the level of sort of numbers that folks are looking forward with regards to that change.

Understood ,and then I guess the process will take its time, I guess. -- do you reckon this could be kind of behind with these outstanding things in 6 months, 12 months, 18 months, 2 years, so just give us a feel in terms of where -- the way the U.S. legal system works. How long you would expect before we can hopefully get some kind of resolution?

Yes. I think from a time duration, it's also tough to guide. Obviously, I think you've got a management team who's been really focused on bringing these legacy matters to conclusion. I think we have good track record to date, and have been focused on the larger ones first and we'll continue to actively manage these moving forward and with a focus on bringing them to resolution as soon as we can.

Okay. Switching gears then to, I guess, the market and SUBLOCADE. It would be helpful if you could give us a little bit more color on market trends, where you can either in terms of volumes and pricing? And where you see some volume changes. Because certainly, you mentioned sort of seasonality in your kind of opening remarks, but some people are wondering that in terms of the competitive environment, you're either seeing greater use of generics. You obviously be seeing a new entrant kind of SUBLOCADE with kind of Brixadi so any changes since September would be helpful to sort of understand those moving parts.

Sure, James. And let's just start with the overall market first. I mean, addiction continues to have a huge unmet need. Self-reported over 10 million people that have used opioids, just over 3 million that are diagnosed and a small number, less than 2 in 10 actually in treatment at any 1 time. So there's a huge unmet need. We expect the market to continue to grow. It's kind of growing in the mid-single digit sort of range at this time. And we continue to see good tailwinds from the administration of funding and making interventions to help with access -- breaking down -- increasing access and breaking down barriers, [indiscernible] DATA 2000 removal. So that, I think, from an overall market continues to be incredibly attractive. And as you look towards SUBLOCADE and LAIs as a subset of the broader buprenorphine medically assisted treatment, and I think there's a huge opportunity here to really help patients and certainly plenty of room for multiple players to be in here. As we look to where things have been in the short term, again, quarter-over-quarter, when we look at the front half and the back half, we were obviously in mid-teens quarter-over-quarter growth in Q1 and Q2. People have seen that slow to 8%, but again, this bit of seasonality that's in the back half of the year, we had a 55% year-over-year growth in Q3, right? And when you look at the top end of our SUBLOCADE guidance in Q4, it's a 50% growth rate that we're seeing there, too. So people quarter-over-quarter, I think, are saying, "Hey, is it slowing? Is this going to be the new normal?" Again, when you look back to last year, we saw similar rates of slowdown in the back half on a quarter-over-quarter and trying to figure out exactly what that certainty is about has been a bit tough for us in market research. But we don't see the same seasonality with the orals. And we seem to think that it's -- as we look at the data, when you're going from abusing opioids into treatment and you're doing daily medication, it's less of a transformation than going to long-acting with once a month sort of injectable. So we think that has some of the seasonality in it.

Okay. I've had a question which I'll kind of throw in here as part of my follow-up question to that. And that is, I guess, when we look at sort of the second half of this year versus last year. One of the kind of the understanding [indiscernible] is Medicaid ending the automatic enrollment on July 1. And so if patients kind of have to enroll annually, if people aren't either on the drug for kind of a whole year, how disruptive has that been? And I guess the second part to second half -- the second part of the question is Q4 this year, you obviously got the ramp of kind of Brixadi. So I guess what are you seeing either in terms of the scale of the launch or the areas of the market where you're kind of stronger, just to kind of -- I know you don't talk about other companies, but I guess just in terms of the market impact that is having, either it's creating the market, cannibalizing patients or whatever that kind of might be what's setting is used, few things in that but...

Let me handle both of these James. I think, the first one is if there is an impact with regards to this Medicaid renewal, the fact that the COVID emergency sort of renewal has ended and the muscle memory at renewing your plans has led to some people dropping out. If there's somewhere around from 94 million, 95 million lives covered. We've seen over 5 million sort of folks fall out of treatment. By the time you take -- a portion of those are children, a portion of those aren't potentially OUD patients, we think the net impact might be a point or two of growth, but it is not what's driving the -- it's the seasonality that's driving kind of the quarter-over-quarter. So there is an impact tough to really isolated but that might be a point or two with regards to that. And we'll continue to assess that. I think most of the people on the call know that just due to the nature of the journey that our patients have been through, we do have a disproportionate share of our patients on government payer programs. So we are disproportionately impacted this versus maybe other medications out there. So I think the second part of the question is Q4 and when we look to the impact of having a competitor in the market. And what I can say is, listen, let's just drop back. There is such a huge opportunity for both players. Their launch is in such early stages. I think you need to really talk to Braeburn and to Camurus with regards to how they're doing. We're not seeing anything in the early stages of this. That is different than we expected that is impacting anything to do with our guidance this year. Our interim guidance of exiting 2025 at a like $1 billion run rate or our peak revenue guidance. There's nothing surprising with regards to the launch of any disproportionate impact in the early days.

I've had a clarification question to come in when you mentioned there was an aspect of SUBLOCADE, which wasn't included in your also $1.5 billion peak sales target. Can you just remind just the benefit of the person and everyone else, what that is to help us understand how that may have shifted?

Yes, certainly we upped our guidance at our Capital Markets Day early December last year to greater than $1.5 billion that included sort of the market dynamics that were in place at that time. And before that, we've always talked about, listen, if something major that were to change in the landscape, such as enabling alternate sites of care, that could change our footprint, and it could potentially lead to incremental revenue. And it's exactly what happened just before Christmas last year, the U.S. government eliminated DATA 2000. And DATA 2000, it was put in place, James, back in 2002 to shift buprenorphine from a restricted class similar to methadone that had to have individual dosing to actual take-home medication. Now DATA 2000 never envisioned anything other than an oral daily dose take-home medication. It didn't envision the fact that there would be long acting in the market and the inadvertent side of it is that it prevented alternate sites of care for small independent doctors' offices. They didn't want the administrative burden of a specialty product that's controlled substance that put a real burden on their practice. And in other spaces they typically could setup and send their patients to someone else to inject the medication. But DATA 2000 eliminated that, the interpretation of the law was that you weren't allowed to. So by taking that away in December, suddenly, it opens up to these independent physician offices, remember our strategy is in organized health systems, large systems that have the administration and back office to manage this product. It suddenly opens us back up. And the early signal of that was having our first alternate site of care provider up in June. That's Albertsons, they're on the front end of this. They see it as their role in helping with the opioid epidemic and they now have 1,000 storefronts where they can inject long-acting buprenorphine, SUBLOCADE. And for us, these are patients that we hadn't built in to our revenue projections when we built up to the greater than $1.5 billion. So it's incremental revenue and thus, incremental value for shareholders. So a really great development in the space.

That's very helpful. And I guess, at the time when you gave your guidance, you gave a sense in terms of what the number of patients could be. Are you able to give us a number in terms of what the patient number you expect that would increase the opportunity by.

No. We haven't gotten down to that level of granularity, James. What we have said is -- well, it was a great try. But this will take quarters and years. We have to build up a full national sort of network here. So Albertsons is great, but it's 1,000 storefronts. We want to get as close as we can to a retail experience, which means the proximity of going for these injections needs to be close to the patients, and we'll be looking for additional partners to add on and the beauty of that is, as we've done our sales force expansion, adding this incremental 40 customer-facing people out there, in addition to 8 in criminal justice, we'll be able to have now the increased capacity to reach these independent positions that SUBLOCADE can be in there and we'll be able to pull through as the network build out.

The other question, which we get quite a bit is at least kind of in the comparison to Brixadi. The headline price is lower, I think 17% lower. So with cash conscious payers, is there a risk that some contracts don't get renewed or you have to be lower to be competitive?

Yes. What I'd say, James, is we believe that from a net price and from a usage, we're more than competitive with any other long-acting out there. And so for us, we've not seen pricing pressure in the category and continue to retain. We have almost 90% of lives that are covered. We have a co-pay card that for commercial patients, albeit a smaller percentage of our patients, it does take their co-pay down to 0. So there isn't kind of an elasticity issue when you get at a patient level from a walk away. So still great lives covered almost 90%. And from a patient standpoint, there shouldn't be a price issue.

Understood. We've also had some feedback that a smaller needle size. And I guess the weekly option from Brixadi is a real kind of differentiator. So again, some investors are kind of -- we get sort of push back why the volume growth won't slow down. So I guess I'd be curious to get your thoughts on that.

Yes. Rather than getting into features, right, I think, which I kind of see those as features. And I'd say, I think with SUBLOCADE, what you're getting is a paradigm shift in treatment. One that we just don't see from other long-actings in this space and in an inherence based sort of area with synthetic opioids that are ending up causing overdoses of almost 80,000 a year, of which 90% of them are synthetic opioids, we think our paradigm of treatment is a huge differentiator in the space. So we just don't see other long-actings that are up to therapeutic levels in 4 to 8 hours, right? And we just don't see that with other long-actings. We don't see that therapeutic level being maintained for the full 28 days, payers are paying for a medication. Patients expect that therapeutic dose to last the full month, we just don't see that. And then the uniqueness of our therapeutic dose that we maintain the entire month, we believe, is quite differentiated also. The maintenance dose of our medication does 2 to 3 nanograms per ml, which occupies the receptors in the mu receptor where the opioids work, with a higher affinity buprenorphine at a level that they're saturated. So there's no room for those full agonist opioids that cause the euphoria and the respiratory depression to be able to gain access. So it protects those patients in a moment of weakness. And we also see that for our 300-milligram dose, which is an option for people that physicians feel there's a benefit in maintaining the 300, it has about a 5 to 6-nanogram per ml concentration. And we see about 40% of the volume remaining on that. So it's a very unique therapeutic sort of paradigm of treatment that we have that we just don't see differentiated. Listen, I think some of these features that get talked about are interesting, but I think in the market with the performance for the patient, I think they are important, and we haven't seen any of those be a barrier to treatment in the years that we've been out there in driving the year-over-year growth, we've been seeing.

Switching gears then to manufacturing. I guess you talked a little bit about that in your kind of opening remarks. I mean you successfully use contract manufacturers for many time, at least as far as I can remember, acquiring a facility was never really kind of part of the road map. So it was a surprise to me as well. I know that was kind of announced. So I guess -- now what are the issues of the contract manufacturer -- I guess what are the kind of the drivers which kind of potentially led to this decision? Because this is a material investment for you?

No, it is. It is an investment. And I think strategically, it's one that's certainly in the best interest of shareholders to have the supply of this build up secured well beyond greater than $1.5 billion, we think is key. And currently, we have one partner with 2 sites, and we think the diversity of this in the BCP is a key investment. And with that as a given -- we had to look at our strategy with regards to this product. Do you find another partner or do you bring this in-house and given the nature of this product, this is a hard to manufacture very unique product, and it leads to a great product profile and a great paradigm shift in treatment, but the manufacturing is tougher. And so we think by bringing this in-house, given there's so few parties that are -- have the capability to -- just by bringing this in-house, it shows up the capability and it's worth the investment. The capital would have been spent if we've gone to any third party, so it really is about the upfront and the $30 million that we would have had. And so we kind of looked at that investment versus a greenfield to have this sort of flexibility and getting and acquiring an FDA-approved sterile manufacturing with a team extremely capable and have had good inspection sort of history, we think it gives us a nice fast head start on getting that additional site.

It's a risk mitigation measure because I think you say kind of conspiracy there in terms of -- when we had sort of conversation with investors. Some people have tried to understand, I guess, previously, you've cited supplier issues in Australia. And I think something we're looking at is thinking, are there potentially sort of supply issues in the U.S., potential canceled contract on CDMOs, are you are not going to have CDMO capacity to kind of deliver in your peak sales. So I think as those sort of types of things where I think there have been a little bit more caution in some of the discussions we have more recently. I'd love to have any thoughts on that, if you can?

Yes. So let me be very clear. This is not an issue with regards to the supply of the business over the next few years. This is looking to the future. When you're doing supply in pharma and even more in sterile manufacturing, you're not navigating a speedboat that you can turn on demand. This takes years to build up your sites and be ready to go. And so you have to think 3 years in advance. And as we said, we're not going to be up and running at the site until 2026. So I think for me, that is a key element. And I respect folks remembering our issue in Australia. That was not about capacity of supply or our partners -- issues with our partner that we currently have. That was very specific. There's a different spec product in Australia with regards to that, and we had a batch failure. And that's what caused the disruption in supply over in Australia for 3 months. It doesn't have anything to do with capacity or the capabilities of our current partners. So this is a truly -- we have a greater than $1.5 billion product, and we want to make certain that we're able to provide it moving forward.

Thank you for providing that reassuring commentary. I guess another question is, you've obviously announced this investment, and I guess, will tackle the cash impact separately. You talked potentially about $20 million worth of operational savings by '27, but there's kind of like a ramp-up phase in order to get there. So can you help us think about what the investments are either starting this year, going into next year and then thinking about kind of like the net benefit. I mean, as you know the largely kind of fixed cost operating model can be quite sensitive to changes in spend. So can you help us think about when that's likely then going to be rationalized or you can get the full operational benefits from being scaled up. Can you tell me over this kind of period, there's new investments to help us understand that would be really helpful. On the P&L level and then we'll talk about cash.

I think Ryan did a really good job outlining this in our third quarter results. Obviously, $5 million cash upfront, some contracts that had losses with current partners that we take to the balance sheet and some very modest kind of losses over the next couple of years just operationally that don't go to the balance sheet. So I think when you think of that, it's a very little impact in the adjusted P&L moving forward. And we'll continue to look at that team and operationalize it. Now the investments we'll make in tech transfer, getting the line in there. We can do all of that while the team continues to function and continues to keep their muscle memory the sterile manufacturing with the current customers. And then what we'll look to is go live in '26. And as we start to have a full year sort of impact, we start to see $20 million of savings over a year. So if I was to kind of summarize this, we're doing it for BCP. We would do it even if there weren't cost savings to make certain you had supply of this, but we're going to get at least $20 million a year in savings. So it's not just better, but it's also cheaper, and there's a huge NPV on this project.

Just to peel one more layer on the onion, if I may. And that is modest costs that we're talking low single digit, low double digit, to help us sort of understand that? And I guess you're talking about adjusted -- so are there actual larger kind of costs, which will maybe be reported kind of over that period? And I guess if it's $20 million when that sort of ramped up, at what point do you expect that to be breakeven in terms of the net cost on the part to $20 million?

So let me kind of ease it out. We'll put the $30 million of contracts on to the balance sheet. As the costs that relate to that come through the [ P&L ], those will go against the balance sheet. The impact from a margin standpoint is mid- to low single digits is what I would say, over those couple of years. So we're very modest when we say that. And listen, as you look at $20 million a year of cost savings in 2027, those are net savings to the bottom line on the site. You'll twilight the current contracts as SUBLOCADE comes up, and so it will be just producing for our demand. So this can breakeven pretty quickly.

Okay. So it will be $20 million in 2027. And then I guess you say how it's very [indiscernible] accretive, I guess when you consider the cost upfront, just kind of curious what the return hurdle you had or when you expect the payback period over the X number of years to help us understand the value creation from the site as well.

Yes, listen, we did not talk through all that, but I think it's pretty easy if you're getting $20 million a year of savings starting in 2027, I think you can back into the payback period with regards to the site.

Okay. Switching gears a bit to PERSERIS and Opiant. I guess you cited some near-term challenges of PERSERIS for the competitor. So I guess how much spend is required to address this?

Yes. I don't see incremental spend on this, James. I think what we've got is that the competitor has entered. The competitor has more than tripled the amount of reps out in the field that we do with well over 400 and what we're seeing is a bit of share of voice and a bit of noise in the system in that they've come to market also with a risperidone subcu injectable. And as we look at our product, we look at the experience that the physicians continue to have, we see these as short-term headwinds with regards to SUBLOCADE. Once the noise settles and folks see the difference between their asset and PERSERIS. We expect to continue to return to growth. If you -- even if you look at the front half of the year, we were growing at nearly 60% year-over-year. So physicians like this product. It was at a very good growth trajectory. And when we -- if we hit the low end of our guidance, which is what we've guided to, we're at a kind of a breakeven run rate exiting '23, entering '24. So from a cost standpoint, this is truly about winning in the physician's offices. There isn't a lot of ancillary spend supporting this asset.

And how long do you think it could take to get to the low end of your peak sales of $200 million to $300 million because I guess when you look at the ramp, obviously, it was launched during a tricky time anyway, but it has been kind of quite slow. Some people also ask us the question that ROVI potentially has a competitor on the market, in February if Risvan gets approved and we don't know if they're going to partner that or what that means. So there's going to be another competitor in that space, but I guess, potentially. And so I guess with the kind of the progress that you've got, can you help us understand the inflection of this product because some people sort of wonder why you keep them. I mean, obviously, it's good from a diversification perspective, but if you continue to not see the inflection that I guess -- we all sort of expect, I think people just look at it from a value accretion perspective as well?

Yes, yes. And we do also, right? And so exiting this year, we're kind of at a breakeven and then everything else is accretive to this asset with a relatively modest sort of investment of the sales force. We see that as in the interest of shareholders from a diversification play from a return on investment sort of play. When in hits the $200 million to $300 million of revenue, we've not guided to that timing. But when -- as it starts to return back to growth with the teams, call platform being totally up to the -- we had some vacancies in Q3 back up to full complement. We'll guide on '24, which will be a nice interim step for investors to kind of traject -- make their own trajectory up to the $200 million. We haven't seen anything. Maybe the last thing is we haven't seen anything really from [ UZEDY ]. We knew they were out there when we gave our $200 million to $300 million peak revenue. We kind of had a feel for their product profile. We haven't seen anything that precludes that. Obviously, the competitor has a bit different aspirations as they go into the market. But we're looking to carve out $200 million to $300 million of sale in a $4 billion to $5 billion market.