Which one was it? The transition. Yeah, we're good. Yeah. Hey, Chris. We're all good. All right, thanks. Sorry, they don't leave us much time to run from floor to floor here in between these meetings. Thank you all for joining us for our next presentation. We're happy to have Collegium here with us. For those of you who don't know me, I'm Glenn Santangelo. I cover the specialty pharma sector at Jefferies, along with a couple of other sectors, actually. But you know, Collegium's been a volatile stock here recently, and I think there may be some things that are being overlooked here that I think are worth discussing with Colleen and Scott. So let me introduce them. It's right to my left is Colleen Tupper, who's the Chief Financial Officer of the company. Scott Dreyer, to her left, is the Chief Commercial Officer, and Chris James is the handsome gentleman in the front row, who heads Investor Relations. So if you guys have any questions, by all means, please feel free to reach out to them. You know, Colleen, maybe, maybe I'll start with you. Why don't we... I guess we're a few weeks past earnings season, but I'm not so sure the ink is completely dry on that press release yet. So why don't we start with a quick review of 1Q results. Revs and EBITDA came roughly in line, from memory, and I'm kinda curious how you think you performed, or the company performed, relative to at least your initial expectations heading into the year. Yeah, great. So Q1 is off to a great start for the year. It was in line with our expectations- Is that mic on? We delivered revenue of $145 million and Adjusted EBITDA- Okay of $92 million, which was up 5% year-over-year. We reiterated our full year guidance across all metrics, which will deliver revenue in the range of $580 million-$595 million, and EBITDA in the range of $380 million-$395 million. So overall, the year is off to a great start, and maybe I'll ask Scott to jump in on the demand front. Yeah, sure, and when it comes to demand, again, 100% in line with our expectations. One thing we were really encouraged by is specific to BELBUCA. BELBUCA, we acquired from BDSI in 2022. Starting in the second quarter of last year, we resumed growth of BELBUCA, and it strengthened quarter after quarter, including in the first quarter, where BELBUCA was up about 4.2% year-over-year. That's really important, especially on our category, where at the reset of the year, you have a lot of pressure on co-pay and deductible resets for patients. So really encouraged by the growth there, and we're seeing that continue in the second quarter. For Xtampza, for those that follow us, we did some contract renegotiations that are part of our strategy, and so prescriptions were down but right in line with expectations based on a plan that we walked away from at the end of last year. Okay, so it kinda sounds like business as usual. Obviously, investors that were paying attention saw the massive stock drop, right? And I think, you know, it's worth just spending a minute talking about the CEO change at the company, right? So, you know, Joe Ciaffoni, who I think everybody knew and was comfortable with, and the... You know, the company had been doing great. Stock was up significantly year to date, heading into that 1Q result. And I think his departure sorta came as a surprise, and so I don't know if there's anything that either of you can share about that departure and maybe what the company's plan is from here. Yeah, absolutely. So Glenn, as you saw in the follow-up discussions, Joe and I did our round of investor meetings post-earnings. So while the market may have been a bit surprised, it was not an abrupt departure by any means. And frankly, the company is in the strongest position it has ever been, and us internally would argue that now is the right time after about a sevefive-year tenure, 5 years in the CEO post, for Joe to move on. We had the unique opportunity with Mike Heffernan as on our board, as the founder and former CEO, to step in in the meantime in an interim CEO role, and the board had launched, prior to announcement, an external search for the new CEO. So that's well underway, and really, from a business perspective, the strategy remains intact. The board is looking for someone to continue that strategy and bring us to the next level. No change from a business or strategy position, and the board has confidence in the management team to continue to execute on the strategy we developed together with the board. Okay, thank you for that. I mean, maybe let's just talk a little bit more specifically about the guidance. As you mentioned, you reiterated that guidance. You know, I think a lot of people focus on the EBITDA in particular. I you know, and if I look at consensus, you know, the treet is sort of modeling that a little bit below your guidance range. You know, digging into that, I think it's maybe a factor of one or two guys that just haven't updated their models, so I think it's more of an anomaly more than anything else. But I'm just kinda curious, in your callbacks, have you heard any feedback or pushback that might suggest that your estimates are a little bit on the aggressive side? I'm just trying to, you know, also make sense of the drop in the stock price, unless I'm just assuming, or we should assume that it's the surprise departure of, you know, at the CEO level. Yeah, I'd say what we've heard in follow-up calls is really a surprise as well. I think as some investors have portrayed it, a bit of an overreaction in the stock movement, and that it was a bit lost on the solid financial performance for the first quarter, and frankly, our bolstered outlook going forward, especially on the heels of announcing the Hikma agreement. And so I, I think the investors we've spoken to understand the dynamics of the company. Specifically, to EBITDA, our guidance, as mentioned, is $380 million-$395 million for the full year, being about a 6% year-over-year increase. I think in addition to a few of the models not being updated, the aggregator has a bit of an issue. The individual models themselves- Mm ... range between 379 and 387 on the EBITDA line. So I think that is an anomaly with the way it's aggregating right now. Okay. All right, we always go back a few weeks after the quarter and try to look at where everybody shook out- Right ... relative to the guidance and try to find places where things seem off. The individual models are pretty tight. ... Okay. All right, maybe on this topic of profitability, if we could just talk. If we look at your revenues in the first quarter, you're essentially sort of flat year-over-year, but your operating income was up 19%. You know, can you walk us through, you know, the drivers of that gross margin sort of being so up so much, and, and obviously, that flowed down to the operating margin. Yeah. Specifically, in the first quarter, there were two non-recurring items that impacted the first quarter of 2023, and didn't reoccur in, in this year. So it was the inventory step-up wind-down from the BDSI acquisition, most specifically on, BELBUCA, so we no longer have that recurring charge this year, as well as operating expenses came in about, overall 10% down, which was, partly attributed to a one-time legal settlement that we had in the first quarter of last year. So, you know, our, our margins, as we expect from a full year, will appreciate, but you had a bit of a timing differential year-over-year. Uh- OpEx did come down, and as you've seen, Glenn, we're also front-loading. We do significant OpEx spend in the first quarter, and then the rest of the year it comes down. Yeah. And maybe just on that, those operating expenses, I think you sort of forecasted SG&A to be $120 million-$125 million, which I think was some sort of sequential improvement relative to kinda where we were. I mean, when you think about the one-time items that you discussed that impacted the first quarter, how should we think about those playing out in the margins and the guidance through the balance of the year? So our adjusted OpEx, which we guide to, excludes those one-time items, so this year we're expecting OpEx in the range of $120 million to $125 million, which is a 1% decrease year-over-year. Okay. All right. Maybe, I don't know how much you, you feel comfortable talking about, 2Q at this point, but I, I don't know if there's anything, you know, you can speak to at this point in terms of how things are trending. And, you know, Scott, maybe I'll, I'll sort of flip this to you. You know, the consensus or, you know, models are sort of modeling flattish revenues, but that's 5%-6% growth sort of year-over-year. Yeah. I mean, can you unpack that? Yeah ... that for us a little bit? I mean, does that kinda- Yeah ... make sense? No, that's great. So look, second quarter is going right in line with what our expectations are, so that's good. As we often see, right, we start to have a little bit more coverage gap expense hit in the second quarter, so that affects the brands a little bit more versus sequentially in the first quarter. But we expect to be up versus the second quarter of last year. And then specifically on demand, as I said, BELBUCA continues to grow and do well. Last week was a weekly high over the last six months, and we expect XTAMPZA to settle, meaning after the negative impact of the formulary change, we're now seeing stabilization of scripts, and that's what we expected, so should be a good quarter. You know, it's funny, when I was looking at... I mean, before we came, we were trying to check the IQVIA trends, and just sort of looking at April, it looked like we, to your point, we saw some improvement in BELBUCA in April. And we saw the - at least the trend in Xtampza and Nucynta both get incrementally... They, they improved slightly. I mean, the declines were less relative to where we were in 1Q, and it kinda sounds like- That's right ... that's the theme sort of playing itself out in 2Q. Is that all a fair assessment? That's 100% right. That's right. Yep. All right, so the company strategy. I—you know, I've only covered the company for 18 months, and I feel like we've been talking about... Well, maybe it hasn't even been that long. We've been talking about the potential to do an acquisition to sort of, you know, ultimately, you know, move beyond opioids. Now, when we think about the CEO transition, has anything changed? I mean, would the company dare do an acquisition without a permanent CEO, even recognizing, you know, Mike is a co-founder, and he's obviously very familiar with the business? It seems like, I don't wanna call it an interesting time to do a deal, right? I mean... So I'd say the short answer is there is no change to the strategy. If you recall, in 2024, we think about what we're focusing on sort of two prongs. The first is to maximize the value of the existing portfolio, and delivering on our guidance will be sort of record financial metrics across the board. The other arm of that is to really effectively allocate capital. And in 2024, what we know we will do is we will continue to de-lever, and we will return value to shareholders via our share repurchase program. And every quarter, frankly, every day, Collegium gets financially stronger and is poised to do the right deal at the right time. Again, that strategy is developed with the board. It's our strategy, and the management team has been executing it. We do have priority assets and companies that have been on that business development list for some time. None of them have come off the board. And so when our view of valuation meets theirs, we're very confident we can get a deal done. But we also understand our financial strength, and we do not feel any pressure or desperation. Hey, hey, hey, Scott, I mean, the M&A parameters are kind of broad. I don't know if you wanna just quickly review for everybody- Sure ... kind of what, what the company's sort of looking for. Yeah, you, you got it, Glenn. So, so what we're looking for next is commercial stage assets with a couple of principles. One, it's a diversification, so to move out of pain into another therapeutic beachhead, so that's number one. We're looking for assets that have a peak potential of $150 million or more. That's number two. And then also, we wanna go into a therapeutic category where this is just a first step, but where we're able to add additional things to really fully leverage the commercial infrastructure going forward. So the last thing I'd say is, we're looking for things that have patent into the 2030s. That really helps bridge at least over the course of the next 8-10 years. So that's what we're looking for. There's a lot of opportunity out there under those parameters, and we're actively hunting. Yeah, Colleen, can you quickly... And it sort of sounds like everything's sort of still on the board, at least the companies you may be following or the assets you're paying attention to. So maybe, you know, it suggests that you're willing to be disciplined, but in the interim, you've been paying down debt and buying back a fair amount of stock. And so could you just quickly summarize for people, like, how far you've come in terms of debt paydown in the last sort of 12 months and you've had a series of share repurchase announcements made? So could you just bring everyone up to speed in terms of where you are on both those fronts? Sure. So at the end of the first quarter, we had about, just shy of $320 million cash on the balance sheet. Our debt is comprised of a term loan with a balance of about $367 million at the end of the first quarter, and 2029 maturing convert of about $240 million. So we're paying down our term loan rapidly at the pace of $45 million per quarter. At the first quarter, our net debt to EBITDA ratio is just under one, and it will be de minimis by the end of the year. So cash is being utilized to operate the business, pay down debt, as well as return value via share repurchase. So we have an authorization on the share repurchase front in place for $150 million. That runs for the calendar year 2024 to the midway point of 2025. And on the Q1 call, we announced, as part of that, a $35 million accelerated share repurchase program. In advance of that announcement, we had repurchased just shy of $140 million of shares thus far. Hey, Scott, can we shift gears and talk about the assets? Let's talk about Nucynta first, right? Sure. Essentially, could you remind everybody the current IP on Nucynta, you know, when the expiration is, and the extensions that you're kinda seeking, and then we're gonna shift gears and talk about the recent announcement to make, you know, Hikma the exclusive authorized generic partner. Sure. So let's talk about the LOE first, the extensions, and then we're gonna talk about Hikma. Sure. So yeah, I'll start very simply with, look, first, Nucynta ER expires mid-2025, but we filed for a pediatric extension, which we expect to receive, which would take it to January of 2026. Same applies if you look at Nucynta IR. We have patent until, I think it's 2027, January, with the extension that we expect to receive on the pediatrics. So that's what we're planning to, and we should hear about that in the second half of this year. Okay. Can you talk about the Hikma deal? Yeah. the rationale for doing that Hikma deal? Sure. Yeah, absolutely. So in the... Just before, I think, the first quarter call, we announced that Collegium has entered into a partnership agreement with Hikma. They will be our authorized generic partner. We're incredibly pleased with the terms of that agreement, and it, as we noted on the call, bolsters the outlook of the Nucynta franchise. Couple significant points to share with you is our profit share, the Collegium profit share, starts in the mid-eighties and will go down modestly, depending on how many generics enter the marketplace. And so we're pleased with those terms. It gives Hikma the opportunity to have a date-certain launch just before those dates that Scott just mentioned. Importantly, royalty payable to Grünenthal in mid-2025, which is a IP trigger date, the royalty steps down from 14% to 7%, and at the time of the first generic launch, i.e., Hikma's launch, it will step down to zero. So we really look at the Hikma agreement as giving Collegium certainty, bolstering the outlook, and if another party enters from a generic perspective, we secure our base case, and if someone doesn't enter, which is a question mark in this space, we secure nearly all of our upside. Okay. You know, since you just brought it up, I mean, Teva was the other company that had settled for 2026 on Nucynta. I mean, I don't know if there's anything you're aware of or can share about their plans, or at least your best guess at this point, you know, in terms of their manufacturing a generic version. I mean, I don't know if you have any visibility or- So I can't speak- - insight. I can't speak for Teva, but to give you an, a sight of that first date, so Nucynta ER, as Scott noted, is potentially, you know, early 2026. There are three potential entrants: It's Hikma, which we now know is our authorized generic partner. It's Alkem, which can't enter in 2026, they're actually out until 2028 because they did not adopt a skinny label. And the third is Teva. And so really, it, it puts, you know, eyes on there are limited players that will come in the market with Nucynta ER, and I think the market will get its first real indication on what Teva's intentions are there. Yeah. Are there some hurdles with manufacturing the generic version here? Maybe people don't fully appreciate how difficult it might be. Yeah. It's not complexity-wise, but what's interesting is tapentadol, unlike oxycodone or morphine, is only used in the Nucynta products, and in the US, which is where it needs to be manufactured due to DEA regulation, there are four DMFs, only one of which is at commercial scale, which is our exclusive supplier, and the three others are at pilot scale. They could ramp up to commercial scale, but that's a multi-year endeavor and about a $10-$15 million investment. We don't believe anybody has started that work as of yet. All right, so how do we take all this together, right? You have an authorized generic, you have a royalty sort of going down, we have uncertainty around Teva. Like, is there any way you can help us sort of think about how we model this thing 2026 and beyond? Yeah. I would say Collegium's base case is that there will be generic entrants. However, there is a very reasonable possibility that that plays out in a more favorable way. I would look at Nucynta franchise revenues to be stable the next few years, exiting 2024, and I think what we'll see is a much more robust, bust, and longer-term tail than you would typically. Scott, let's shift over to Xtampza. You talked about renegotiating some of those contracts. Yeah. We saw a better gross margin in the first. I'm sorry, better gross-to-net in the first quarter relative to maybe what you guided for the full year on the- Yeah gross to net for Xtampza. I mean, is that a one-quarter anomaly, or is that indicative of maybe how the year could play out? How should we think about the- Yeah the gross to net on Xtampza? Yeah, good, good question, Glenn. So look, the main thing is guidance still for the full year is 56%-58%. The first quarter was a little bit more beneficial. Obviously, Coverage Gap doesn't really start to hit till the second or the third quarter. So what you should anchor to is that 56%-58% guidance that we've given for the full year. ... Okay. And the IP around Xtampza, can you just sort of comment on that? Yeah, it goes till 2032 right now. We have patents that go till 2036, but 2032 is when the first entrant in our agreement with Teva can begin. There's been only one ANDA filer thus far for Xtampza. It was with Teva, and we've settled with them for September twenty thirty-two. The Gross-to-Net story on Xtampza has been continuously improving. Could you maybe even wind us back to 2023 and some of the contract renegotiations? Sure. And is there more to actually do? I mean, you know, not that you wanna comment on 2025 at this point, but how should we think about- Yeah ... you know, where you stand in terms of renegotiating all the contracts that are available to you? Yeah. So we had a huge opportunity in 2022 and 2023, where essentially we renegotiated contracts that cover 84% of all Xtampza prescriptions. And at the end of that two-year period, we basically improved margin for 77%. 23%, we were removed from contract, and the rebate went to zero. So overall, in that two-year period, significant improvement in overall gross-to-net. Now, as we go forward, Glenn, here's how I would articulate it: We're committed to growing revenue year after year for Xtampza. That will happen in a variety of ways. It could happen through further renegotiation or walking from contracts. It could happen through new wins, but we will only do a win where it will be profitable. So I'm not gonna give a rate that's not profitable to grow prescriptions. And then, of course, the third is organic growth. Xtampza still has really strong coverage in both commercial and Part D and room to grow within those plans. So every year, as we enter the next year, what plays out will be a mix of those actions, but what we're committed to is growing revenue going forward. Yeah. Maybe, maybe let's just talk about BELBUCA 'cause I think it warrants a lot of attention here, right? I mean, just sort of given the growth trajectory, now it's your largest product, right? And, you know, will get even larger on a relative basis, probably after 2Q. And so could you sort of comment what's been driving that increment... that acceleration of, of growth? Yeah. Yeah, it's a good question. So, as I said, we acquired the product in 2022. Belbuca's a bit more complex than some of the- some sales, meaning it's a buccal film. Our sales force had to kinda get a good understanding of it, know how to sell it. Customers, it's a little bit different, especially since buprenorphine has been used for opioid use disorder. So we spent a good amount of time working on that in the year 2022, and really, off of that, it's execution that's driving the performance, period, right? We see better execution in front of the customer, the prescriber bases are growing, and we're just growing market share. You know, this is another one. Obviously, people focus on the LOE, right? 'Cause it's right behind Nucynta. Could you just sort of remind people the LOE situation and the potential generic competitors, you know, that are in line here? Yeah. There's been three ANDA filers to date, one of which was Alvogen, and this is really one that Collegium was watching closely as BDSI and Alvogen litigated. What's it important about Alvogen is they are the only one with a tentative approval. BDSI prevailed in the litigation with Alvogen, and they were pursuing invalidity, and so BDSI prevailed, barring Alvogen until the end of 2032. The second player is Chemo, who are bound on invalidity to the outcome of the Alvogen trial, but are pursuing non-infringement on their own. To date, they have not successfully produced a product. About six weeks ago, they received their fourth CRL. So we do not think they will successfully produce a product, and we will expect to litigate in the event they do. So we're really less concerned with Chemo. And then the last I'll mention is Teva, and BDSI settled with Teva to allow generic entry in January 2027. What we know is that, to date, Teva does not have tentative approval, and they have relinquished their first filer exclusivity. When did they relinquish that first to file status? I believe it was early 2022. Early 2022. All right, and is there... So I'm sorry, is that date certain, January 2027? That they are permitted to launch, yes. They have permitted, okay. What their intentions are, we don't know. All right. Perfect. All right, I mean, I guess, is it fair for us to watch how Teva plays out the Nucynta situation? Could that be foreshadowing for BELBUCA? Is that- I think it could be an indicator. I think with Teva's focus on branded products and complex generics, there is a question mark in this space, and we get a first look at that with the Nucynta ER date. Hmm. Okay. All right, well, we have 30 seconds left, and so, you know, I, I, I wanna give you each sort of your own separate sort of last word in terms of what you wanna leave investors with, but it sorta sounds like you know, it's business as usual. You know, Joe's departure, while unfortunate, you know, you have someone that can sort of step in, and it feels like the trends are moving in the right direction, and, and now we have these, you know, these situations on Nucynta and BELBUCA that are kinda up in the air, and I think, you know, certainly seems like maybe the tide is, is in your direction a little bit, at least relative to those initial LOE dates. Mm-hmm. But I'll let you guys have the last word. I would say for 2024, we're focused on operational execution. We're on track to deliver on our portfolio and record financials across the board. We're gonna continue to allocate capital responsibly, and we will be ready to strike at the right deal at the right price, and our outlook has improved. Okay. All right, well, thank you very much for joining us, and thank you, Colleen and Scott. Much appreciated.