Okay, let's get started. Good afternoon, everyone. Day three of the 36th Annual Piper Sandler Healthcare Conference. This is David Amsellem from the Biopharma team. We're delighted to have Collegium with us, and we have the team here and new CEO, Vikram Karnani, and so we're delighted to have you all here, and lots to talk about with the recent acquisition and your appointment, so you know, I'll dive right in. I'll start with a question just about the position. I guess, Vikram, what did you see about the CEO role at Collegium that appealed to you? Yeah, thanks for the question, David, and it's good to be here talking with you and the team again. First of all, I think when you look at Collegium, the company has done extremely well in the pain space. A really good portfolio of medicines that has grown in a very efficient way, and actually, if I take this back to a few years ago when I first joined Horizon Therapeutics, it is where we are with Collegium today is not too dissimilar from where Horizon was a few years ago. We had a couple of products that were doing exceptionally well, NSAIDs primarily, and the goal was to leverage the performance of those medicines and build a diversified portfolio company, and I see the same opportunity here. We have a commitment to growth from the team, from a very supportive board, a strong financial profile for the company, strong base, and like I said, a desire to grow. So I think rather I wouldn't call it necessarily Horizon 2.0, but I think adapting that story, that playbook to what makes sense for Collegium is what's pretty exciting to me. Yeah. And, you know, given your background and your focus heavily on rare diseases and launch products successfully in the rare disease space, I guess my question here is, can you talk to whether this could be an area of focus in terms of BD, M&A for Collegium or more near term, or are you focused on leveraging the commercial infrastructure that you gained via the Ironshore acquisition? So great question. I think for my experience, you've correctly identified a lot of focus in rare disease. However, that was one way to grow. It's not the only way to grow. Our goal is to leverage the, in fact, the acquisition that was just completed, the Ironshore acquisition. We think it's a phenomenal acquisition. We like the profile of Jornay. We like what we think it can do for us. It diversifies us beyond pain into a new therapeutic area. And our goal will be to make sure that the commitment that has been made, the infrastructure that has been built, the investment that's going to be made, that we leverage that to the extent possible and continue to diversify. If the right rare disease asset passes our criteria and our screen, we'll certainly look at it, but we won't be looking at rare disease just because it's rare disease. Yep, understood. As part of your longer-term vision for the company, do you see over time the potential for bringing in development stage assets and eventually building an R&D organization? Look, our long-term vision is to build a leading biopharmaceutical company. Down the road, it may make sense at some point to think about having an R&D organization with a pipeline. It adds more terminal value to the company, to the valuation of the company. But currently, as we stand today, we don't necessarily have the expertise within the company to do that. The second thing is making a pipeline bet or an R&D bet is, you know, it's not without risk. There could be a binary outcome. And given our size today, I'm not sure that that's something that would be appealing for us today. Once we have scaled, once we have added more products, and we're off a commercial scale that can withstand a potential binary outcome, then maybe it makes sense down the road. So I wouldn't say not never, but certainly not the focus for right now. Yep, that's fair. This is more of a question for Colleen. Just looking at the capital structure, is there a pro forma net debt EBITDA multiple beyond which you would not go regarding execution on another transaction down the road? Or maybe just talk generally about how much you would lever up as you think about future BizDev M&A. Yeah, in the arena of looking for commercial stage assets, what we've said is we're comfortable we could lever up to three times net debt to EBITDA today. And for the end of this year, we'll be at just under two times, and that will wind down to under one by the end of next year. So what you've seen us done in the past is when we have used leverage, we've then quickly delivered. Yep. Where do buybacks fit in the overall capital deployment strategy? Maybe I'll start with that one, and then maybe Colleen adds to it. The way we think about capital deployment is it's not purely just buybacks. It's not just BD. It's not just debt paid out, right? We think of having a smart capital deployment strategy as doing the right one of these things at the right time. So if it makes sense to do a BD deal, then that's what we'll do. But if there is no BD deal to be done, or if we think that there's a better opportunity by buying back our own shares because the intrinsic value is not being reflected in the stock price, then that's something that we will consider. Okay, so let's dive into Jornay PM, you know, the new, I call it the new shiny toy, that you have in the portfolio, but maybe I'll start with a question about your further investment in the product, and maybe it's a little bit of a loaded question, but what you think Collegium could be able to do to support the product commercially that perhaps Ironshore could not do? Yeah, that's a great question, David. So there's a couple of buckets that I'll put it in. One, I have to commend the work the team did with the resources that they had, right? So nice trajectory of script growth for the brand in 2023, continuing in 2024. But we see two main focal points of leverage, right? One is the awareness among physicians is simply not as high as it should be. That's driven by the field deployment, right? So we acquired the sales force with the deal. We kept the entire team, 126 representatives. If you look competitively, there's sales forces out there in the same space, 180-200 reps. So clearly, we're doing the work now to expand the sales force. That's one main lever, all to grow awareness and adoption. The second is when you look at the profile of Jornay and the difference it can make for a patient with being dosed in the evening and carrying through the next day, there's a tremendous opportunity to raise awareness to caregivers and parents about the drug. And so we're going to put a lot of work and effort into doing that as well. Okay. I wanted to talk about the payer landscape. Maybe do you expect to do anything differently regarding contracting relative to what Ironshore did? Yeah, great question. So first, if you look at the overall marketplace, it's very different than our pain business, meaning 60% commercial, 40% Medicaid, no Part D, right? That's the place we play. What really excited me is in the current state, coverage across that entire pie is 80%. So the coverage of the strong of the drug of Jornay is really strong right now. We will always look for opportunities to expand coverage for patients, but we'll only do it if it's at rates that work for us, like the discipline we've shown on the pain side. So coverage is good, about 80% overall, and we'll look for opportunities when they emerge. Remind us again, Medicaid is what portion of business? 40%. 40%. So, in terms of the Medicaid component, how much of business are you getting from Medicaid, and do you see that as a kind of a big component? I know there's generics in the space, right? So, how do we think about the role of Medicaid and Medicaid patients going forward? Yeah, no, that's actually the split of Jornay's business. That's Jornay's business. 40% of Jornay's business is coming from Medicaid. So the coverage is really strong. It's a viable business. It's different than a lot of people think about Medicaid and other therapeutic categories because the economics are way better for Jornay and Medicaid. So a lot of people look at Medicaid as the least profitable book of business. For us, it's a very profitable book of business. Okay, that's helpful color. Okay, so I'm going to ask the gross-to-net question here, so you know, because I have to, right? So what does the gross-to-net look like on Jornay? And how does that compare to gross-to-net for other brand ADHD drugs? For instance, like Supernus' Qelbree, their gross-to-net is near 50%. How should we think about Jornay PM's gross-to-net? Yeah, so right now, gross-to-net's in the 60s. So it's very similar to what we'd expect of highly genericized categories. So if you look at our pain business at the same time of life cycle, that's where it is. And you happen to mention Qelbree, I'd say it's probably a little different because being a non-stimulant, the competitive landscape's a bit different. But we're in the 60s and expect to stay there. That level is largely a function of methylphenidate having generics and other stimulants, amphetamines having generics. It's really nothing more than that. That's exactly right. Okay. So you mentioned the expansion of the sales organization, so I wanted to touch on that. So just give us an overview of the sales organization that you gained in the acquisition. How is it sized? What's the target physician audience? How many are you calling on? All of the key metrics there. Yeah, sure, so first and foremost, right now, current state, we target 17,000 physicians with 126 sales representatives, and we brought all of those people over with the deal, including the management structure. That was really important because we closed the deal in the middle of a time period that's really critical in ADHD, which is back-to-school season, so that team came over 100% intact. We focused on execution for the last couple of months, and we're seeing in the scripts really strong acceleration through back-to-school. As we look going forward, we're looking at the expansion, as I mentioned, and really, when we look at it, what we see is getting to coverage of about 20,000-25,000 physicians will give the mass that we need to accelerate the brand, and so that's the work we're focusing on right now. And there is a mix here. You know, this is a big pediatric population here. So you've got a mix of psychiatrists, you have pediatricians, you have general practitioners. So what's the mix in terms of what you're currently calling on? Great question. So about 40% of the business is neuropsychiatry. About 30% is pediatrics. But that remaining 30%, the vast majority are actually mid-levels like nurse practitioners or physician's assistants that ladder up to those specialties. Yes, primary care writes, but very little. So it's a long tail of prescribers, but the volume really isn't with them. So think of it as mostly neuropsychiatry and pediatrics. Okay, that makes sense. And you did mention sales force expansion. I guess my question here is, you know, what does a right-sized sales force look like? I mean, I've seen with ADHD, and this is going back with Shire, with Vyvanse, I think their sales force was north. It was big. Yeah, it was big. I'm not saying you're going to get to 600 reps, but where could it go? Yeah. So when you analyze the two main things, which is first, coverage of targeted physicians, and then second, a competitive landscape, which is why your Vyvanse comment was important because it was a very different competitive environment right now. When we look at where the prescribing is done in competitive strength, think of it as getting to the 170-190 range is kind of the range of what we're looking at. Okay. So that's not a massive expansion at all. Okay, helpful. Can you go through the mix between pediatric and adult ADHD usage for Jornay PM, and how do you expect that mix to evolve? Yeah. Right now, it's about 80% pediatrics and 20% adult. That's the current use of Jornay PM. I would expect over time we will grow in both segments, so I would expect the mix could actually shift towards adult a little bit more. You look at methylphenidate use overall, it's more like 60%-40%. But out of the gate. In favor of peds. In favor of peds, right? Out of the gate, the focus and the value proposition continues to be on this massive opportunity in ped and adolescents, right? Because that's where physicians want to go to methylphenidate first, and we view Jornay as the most differentiated methylphenidate. To be clear, methylphenidate, and this is kind of where I'm going with this, is that, you know, the adult market is actually the bigger piece of the overall ADHD market. However, methylphenidate, what I'm hearing you say, is more of a pediatric adolescent product. That's exactly right. Okay. So how do you get more of a foothold into the adult population, or is that just tougher given the molecule? Yeah, I think we will get spillover and continue to grow there through our core marketing activities. It's many other than the peds. It's many of the same physicians writing for adults as well. But the focal point out of the gate here is on ped and adolescent because that's where physicians want to go to methylphenidate first. Now, in terms of where you're pulling patients in from, and it's mostly peds and adolescents, but are these generally patients who have had exposure to other methylphenidate products or even amphetamine formulations or even getting treatment naive patients? Yeah. The vast majority of the use of a drug like Jornay PM as a new option is cycled through other products. It's mostly patients. They're not getting what they need out of the current treatment options, and they're switching to Jornay PM. We get some new, but mostly it's switching, and I foresee that being the primary driver of use for the foreseeable future. This actually leads me back to a question on payers. When you think about the payer landscape, is there significant utilization management in place where you have to step through a generic? Yeah, it's a great question so yet not hard step edits or prior authorizations, but yes, we're able to manage the gross-to-net because we don't have to rebate as aggressively because we're willing to have a position where the patient has been on a generic methylphenidate or amphetamine before. Right, and I would imagine that's not particularly onerous. There's an electronic look-back, etc. Exactly right. So you know, we spent over half the discussion, and we haven't even gotten into the pain franchise. That's a big change. So I did want to move on to the pain franchise and start with Belbuca because you have talked about further investment in the asset in order to drive more growth here. So maybe talk generally about your commercial efforts on Belbuca. Yeah. So since we acquired BDSI, you know, we've talked a lot about just the effort into training our people to understand the product, to effectively engage physicians. So it has been brute execution of our sales force along with some digital marketing activities that has led to the reinvigoration of growth that we've seen over the last five quarters. And we see that strength building over the last couple of quarters. So all execution, there's no other magic bullet there. It's all about disciplined execution that's driving that growth. In terms of new-to-brand RXs, I don't know if you can provide that metric, but what does that look like? How's that trended? Yeah, our new-to-brand, so if you look at the buprenorphine market, right, our new-to-brand is pretty close to overall share. New-to-brand is tough to look at. We have great volume, but in share, it's tough to look at because of the generic patch. The market for pain is only the generic patch and Belbuca. So it kind of is difficult to assess share, but we have very strong new-to-brand volume that continues to fuel the market. When you talk about execution, is it just getting doctors more aware of the product? Is it getting patients more comfortable with a buccal delivery? I mean, help us understand, you know, what you're doing there. Yeah. The primary thing is physicians understanding the value proposition of Belbuca, which is, as a Schedule III, we believe it should be the first choice extended-release opioid. And with the profile it has, which is very different than the patch of seven dosage ranges, if the physician starts on Belbuca and titrates to the right dose, they can get efficacy, as our clinical trials show, where the patient doesn't even need a rescue opioid. Focused on that messaging and bringing that to life with physicians is what we, that's where all the focus is. Yes, we support the patient, the buccal film, but the primary is realizing that if you start with Belbuca and you get to the right dose, you can get the efficacy needed to control pain. Okay. Let's talk about the payer landscape for Belbuca. There's been some changes on the Part D front. I know that's been a priority in getting better Part D access. So just walk us through the recent changes there, what Part D access will look like in 2025, and just your overall contracting strategy? Right. So first off, we did win an integrated health plan that doesn't have IQVIA data, right? But that's about 10 million lives across commercial, 2 million Part D. That was a nice win. We did see Belbuca's being removed from one large Part D plan, right? So losing access at that one, but we know the script loss will be more than offset by profitability because our rebate will go to zero. I think the biggest thing for Belbuca in Part D, we always want as much access as we can possibly get for our brands. And so yes, we've wanted to add coverage, but we weren't going to do it at rebates that didn't work for us. And so the last few years since the acquisition, we've been at the table. We're just not willing to pay the rates it'll take. What's happened along the way is in all of those Part D plans where we're not covered and we're paying a zero rebate, we have market shares that are only five share points less than our national market share, so the team has done a tremendous job pushing through in those non-covered positions and leveraging the unique profile of Belbuca, and so that's where we're focused. We will continue to grow in Part D despite not adding coverage. Yeah. I'll ask another gross-to-net question here on Belbuca, but what will that look like in 2025 versus this year? Yeah. I mean, it's pretty stable. Belbuca's been pretty stable around 50%, and that's what I'd say we expect. Okay. So, is there, I mean, I know with Xtampza, you know, that was a bit of a different animal in that you gross-to-net improved significantly, but you sacrificed some volume. That dynamic for Belbuca is not really at play here? That's exactly right, right? Because that was driven by our strategy of those higher rebates to disrupt OxyContin. Belbuca's been more steady-stated. Okay. Another Belbuca question, and this comes up a lot. I think it's an interesting one, which is, as you look at the potential for loss of exclusivity in 2027, Teva, theoretically, not theoretically, they can launch a generic in 2027. But I'm wondering how you're thinking about Teva entering the Belbuca market given their history regarding opioids? The short answer is we don't know, but there are a lot of indicators that give us really reasonable belief that they may not come into the marketplace. How we will manage our business through that date is we will continue to invest. We won't be taking steps to harvest on the payer or the field force front, and sort of some of those indicators are that they've relinquished their first filer status. They, to date, do not have tentative approval. Opioids is an area which they may not be as interested in, and it doesn't necessarily fit with their strategy, and so there are enough question marks there in my mind to have reasonable belief, and so we'll manage our business and see what happens. So just a quick refresher question. If Teva does not launch, can you just walk us through when your LOE would be if 2027 did? That's right, so Teva has the opportunity to come in January 2027 because of a settlement that they executed with BDSI, which at that time was six months in advance of the then latest expiring patent. Alvogen, who was an important player in this because they do have tentative approval, is barred from the market until December 2032. The third and last ANDA filer is Chemo. They are pursuing non-infringement, and they, to date, have four CRLs. So we don't see them as a concern at this point because they need to succeed in manufacturing and then in IP litigation. Got it. Okay. That's helpful. So let's switch gears to Xtampza and also some changes on the Part D front. So walk us through those changes and what that means for the gross-to-net for the product as we move into 2025. Yeah. So the other change that I mentioned, so again, that integrated health system was a win for Xtampza as well. So some pickup and coverage commercially and in a small Part D business. And then yes, we were removed from one large Part D player of about six million lives for Xtampza. That also we expect will be net revenue positive because the rebate decline to zero offsets the scripts, right? So that's the kind of current state for Xtampza. Going forward, the expectation for Xtampza should be we will grow net revenue. It will be through a mix of either profitability leverage and improving gross-to-net. We could still win a new plan. Like I'm looking to win when I can do it at rates that work. So that could always happen in subsequent years. And then organic growth, like where we have coverage, we still have room to grow. And so those will be every year the levers. It'll just be a mix of what happens. Next year, the primary driver, we expect script decline because of the removal from the Part D plan, but gross-to-net will drive profitability. Can't tell you what the gross-to-net will be next year, but I would say the latest we've said is this year we expect to end at 55%, and you could expect it to be lower given that we have been removed from that plan. Okay. So we'll stay tuned on that. I wanted to fit in a question about Nucynta. I know that there's, you know, it's nearing the end of its commercial life. So how are you thinking about managing that asset through the LOEs for ER and IR? And then, you know, it is a fairly big product. So the question is, you know, once you do go through the LOEs, you know, what is the extent to which you can extract some cost savings as you move through that? So you're right. It is an important contributor to our overall top line with limited investment. So what I would say broadly about the LOE situation there is that I think what we'll see is a longer and more robust tail than you typically would. There just aren't a lot of players that will come in. And with our authorized generic agreement with Hikma and the profitability that we're able to maintain in the mid-80s out of that profit share, I think we'll keep that more robust than one would generally expect. Yeah. And does this kind of go back to opioid hesitancy on the part of generic companies, or is it just, and you know, this is a similar question to Belbuca, but I mean, how do you think about that as it relates to Nucynta, which, by the way, oh, by the way, is a Schedule II? I think that is part of it, but if you look at Nucynta, which is the earliest date at December 2025, there's only three players. It's Teva, Hikma, who's our authorized generic partner, and Rhodes that is out till 2028. Yep. So then the same question. So from a numbers game perspective, again, others didn't come in likely because of it being the opioid. So the same question for Teva and Belbuca, I think applies in this case as well. That's right. So we have about half a minute, so I want to ask one more question to Vikram here. Then just a broad question. Over the next six to 12 months, what are your top priorities? Great question. Continue to maximize the pain portfolio just the way the team has. It's a significant source of cash and allows us to invest for growth, accelerate, significantly accelerate Jornay. Okay. We think there's a lot of potential upside there, and we intend to capture it and be active on our deployment of capital strategically, which means looking for the right deal to add products into our portfolio or doing other things that will maximize returns for shareholders. Terrific. All right. Well, we're out of time. Thanks, everyone. Thanks, everyone in the audience. Thanks, David. Thank you.