2026 Jefferies Global Healthcare Conference

All right. Well, welcome to the Jeffrey Self-Care Conference. My name is Dennis Sting. It's Midcap Biotech and Spec Pharma Analyst here. I have the great pleasure of having Collegian Pharmaceuticals here, CEO Vikram Karnani, as well as CFO Colleen Tupper. Before we kind of get into Q&A, we'd love to just kind of pass it over to you to make some opening remarks around the company and just, you know, the progress that you guys have made over the last 12 months. Obviously, a lot of things have happened, including a sizable acquisition in Asteris. So maybe just level set us and set the stage in terms of, like, where we are right now.

Absolutely happy to do that. So Collegium today is a strong commercially focused biopharmaceutical company. We have two – we primarily operate in two areas. Our legacy, which is in pain management, responsible pain management, which has three products, and ADHD, which now, as of very recently, have two complementary medicines across the board. We gave guidance very recently after the closing of our latest acquisition. We expect sales in the $900 million range, almost half a billion dollars in EBITDA, which is very strong growth compared to last year. We are based out of Stoughton, Massachusetts, just south of Boston. We're about 450 employees in the company, which has seen very substantial growth in the last 18 months or so.

Perfect. So when I take a look at Collegium, there's essentially two big franchises. There's ADHD, which is, I think, around $250, $260, $270 million in revenue this year. But then there's also this big kind of legacy pain business. right so why don't we start off with the paint business right now just maybe just help us understand the durability of that portfolio when I look at consensus numbers I think people assume that new Sinta is going to kind of fall off a cliff in 27 which I don't agree with but also the fact that Bell Buca is going to be down substantially year over year which I also don't agree with so maybe just talk talk us through that dynamic and there are several products but just help us understand the generic situation.

Yeah. I'll kick us off, and then maybe I'll invite Colleen also to jump in and comment. So we take a step back and look at the pain business, three primary products, Xtamsa ER, which goes out to 2033 in terms of exclusivity. We have Bell Buca and the Nusinta franchise, which is Nusinta has an IR as well as an ER medicine. When we take a step back and look at the total business here, we believe that the durability of revenues and cash contribution from this business is, there's way more to it than definitely meets the eye. And for reasons that we'll get into just in a couple of minutes here, we would go through one by one to make sure everybody understands why that may be the case. Nusinta, both IR and ER, we do have an authorized genetic agreement with Hikma, which both the AGs for both products were launched earlier this year. In addition, Nusinta IR, there was a first genetic entrance that hit the market earlier this year. So when we gave our guidance specifically for the Payne franchise, the Payne business represents a 2% year-over-year decline. All of that is primarily driven by the AG and genetic activity on the center. When you look at the rest of the business, which is Extamsa and Balbuca, we expect those two to be flat to low single-digit growers in terms of net revenue. Maybe take the time, Colleen, to just dive into each one of them.

Absolutely. So high level, to just repeat, overall, we expect a longer and more robust tail for our pain portfolio. Nucenta specifically, as Vikram mentioned, has had generic activity already this year. Strategically, we had our partner, Hikma, launch an authorized generic, and we've had that one external generic. So we expect a fairly modest decline in Nucinta revenue this year, which is incorporated in that guidance mentioned. And although we haven't provided any insider guidance for next year, we would expect another for the Nucinta franchise modest decline. Our partner, Hikma, launched an authorized generic both for the ER and the IR at the end of February and early March, respectively. Importantly, we supply Hikma with the product, and we enjoy a high profit share of their sales. Tepentadol as the active ingredient in Nucinta is only available within, is only used, rather, in our products. And so there is limited commercial availability. Out of the four DMFs that are approved in the U.S., only one is available at commercial scale. We believe that that both contributed to Hikma's interest in having an authorized generic arrangement where we supply them, as well as limits EPIC, the third-party generic, their ability to supply more significant volumes. In the first quarter, our total Nusinta franchise revenues, which included the royalties we received from Hikma, were flat compared to Q1 of 2025. And as we move through the rest of the year, we expect some pressure on revenues, which is contemplated in our guidance. Interestingly enough, with Nucinta IR, there are several other tentatively approved generics, and they have thus far not launched. So we believe there's a bit of a stabilization in the number of parties that will come in. And for Nucinta ER, the situation is a bit more positive for Collegium, which is the first external generic that could launch would be Teva, if they so choose to, in July of 2027. And the other potential launch would be from Alchem, and they could launch in 2028, based on some regulatory decisions they had made. So we see, even though there will be modest declines, that Collegium will continue to enjoy significant economics via branded sales as well as our profit share for the authorized generic. As we move into the rest of the paying portfolio, so XTEMS is a little bit more straightforward, so I'll start there. We have an LOE date expected for September of 2033. that is with the first and only filer, which was Teva. Again, I hinted to it previously, but it does remain unclear if Teva will make the choice to launch another opioid. It doesn't strategically fit necessarily with their stated strategy, and there have been some market dynamics that we've observed over the past few years, for example, than exiting distribution of the OxyContin IR generics. And so it remains a question. We don't believe that they do have an interest in launching in this space. So if I move on to Balbuca, which is a little bit more complex, Teva is also the earliest potential generic entrant. They were the first filer for Balbuca. and the predecessor company before we acquired them, BDSI, settled to allow Teva to enter, if they so choose, January of 2027. To date, they do not have tentative approval, and they did relinquish first filer exclusivity. So that, coupled with some of their strategic motives, does present a question on whether they will choose to launch or not. It is our belief that they don't have the intention to launch, and our plans are based on that belief. We monitor very closely, and we are at the ready to take very quick action if that is an incorrect assumption. The next potential generic entrant against Balbuca is a company by the name of Albigin. That was fully litigated, and they are currently barred from the market until December 2032. And then the third and final is Chemo, which they are trying to pursue a non-infringement, but to date have not been technically successful. They've received recently their sixth CRL. So they would need to first be able to produce a product, and then we would move forward on a trial date. And so a long answer to the pain portfolio, there's a fair amount of complexities that come with this space that I think does contribute to that. view of a long and more robust

tail. Well, thank you for that. I think that was really helpful and actually very important, but I'll keep it simple. I don't think Teva is going to launch a generic opioid. So what does that mean for the paying business? It means it's, in our view, in Jeffrey's view, is that it's going to be much more durable out to the 2030s. And then I don't think people necessarily appreciate that new CINTA, the authorized generic, that you guys get 70 to 80% of the profit share. Right? So when I look at consensus numbers for 2020, for 2027, I think consensus is modeling like an 80 million year-over-year erosion in a new center or something like that. And Bell Buca also like a 30 to 40 million erosion there. And all that flows through to EBITDA and that's why I think we are materially higher and that's why we're obviously by-rated. So I think what people really need to appreciate is that the durability of the business is actually fairly good. And it's a very cash flow positive and stable business, which I think is great. And I think that's also a great segue to go into the ADHD portfolio, which you guys have made a lot of investments in over the last few years because that's a way for Collegium to diversify away from pain, right, from opioids, which is, you know, a great decision. But there's, you know, you manage to essentially double Jornay revenue over the few years, and you just double down with the Asteris acquisition just a few months ago. So maybe, you know, before going through some of the details, just talk about the rationale in ADHD specifically, why that product, and why the decision to make the Asteris acquisition.

Yeah, happy to. Look, ADHD is... Take a step back and think about the ADHD market. It's about 22 to 23 million patients generating in 2025, for example, 111 million prescriptions in one year the vast majority 98 million of those prescriptions were stimulants a market this size is also growing at a six percent kegger which is which is actually driven more by the adult segment which is growing almost at eight to nine percent kegger that which obviously implies that the pediatric segment is is is a little bit slower but still growing So what does that tell us? When we look at both Jornay PM as well as Astaris, we see an opportunity to be an important player in the ADHD community. There aren't very many players that provide branded medicines to begin with in this space, in a very large space with still significant unmet need. But there's probably not another player that provides a portfolio now of two differentiated but complementary medicines. So in September of 2024, Collegium closed the transaction of Ionshore Therapeutics, which brought Jornay PM. Jornay PM did exceptionally well in the first year. In 2025, we grew almost 50% year-over-year, driven both by a mix of volume growth as well as gross-to-net benefits. In 2026, in the beginning of the year, we guided to a full year 190 to 200 million. At the midpoint, that's a 31% year-over-year growth estimate. That growth is expected to come both driven by volume growth as well as continuing to refine other things like gross-to-net, as an example. But now with the acquisition of Astaris, which was announced just a couple months ago and we closed about three weeks ago, we now have a portfolio of two complementary differentiated stimulants in the methylphenidate class that in the very early days are being very positively received by physicians, and we'll get to more of that in a second. Maybe if I could take maybe a click down into Jornay and talk about what gives us the confidence for a full year, 31% year-over-year growth at the midpoint. First of all, continuing to see strong demand growth, right? volume growth continues to be a major factor. In Q1, we saw that the adult segment grew 23% year-over-year, and the pediatric segment grew 12% year-over-year. Recall that pediatric segment makes up 80% of the journey business. The other thing is we have a strong back-to-school season coming up in the second half of the year. If you go back and look at last year, We saw significant momentum as we went from the summer into the back-to-school season. That played out. Since then, we have continued to increase our investment in the sales force, increase our investment in marketing programs, be it digital or social, and they were very well received. So we are looking forward to continue to drive that. And maybe on the third point, there's a gross-to-net point also that I want you to comment on.

Yeah, so we expect ongoing gross-to-net improvements and stabilization relative to levels in 2024 and 2025. If you recall, for fiscal year 2024, gross-to-nets were about 71 percent and then improved to a full-year level of about 64 percent in 2025. And we expect gross-to-nets in 2026, as incorporated into our guidance, to be in the mid-60 percent range for the full year and have already seen Q1 perform slightly better than Q1 2025. Our gross to nets in the first quarter of this year was just short of 68% compared to just short of 70% in Q1 last year.

Yeah, I think the only other tailwind that I will add, which was not contemplated at the beginning of the year, but because we closed the transaction that brought Astaris into the portfolio, we've now expanded our target list from 21,000 prescribers to 25,000 prescribers we've expanded the sales force from 180 representatives to 195 representatives that are calling on that list of prescribers very, very, very early days as I said we closed the deal May 12th the very next day we had our reps in training over the next several days and only last week they were in the field selling both products. Early days, but so far the impressions that we're getting back from the field are very positive. They have much more receptivity that they're seeing from physicians. There are lots of offices where we were not able to access before. Those doors are opening up where they were previously closed. So, and the general perception of us now being a partner to the physician's office, serving the needs of an expanded patient population that we can now serve, as opposed to only one product at a time, competing with time with another sales representative, for example. So, very early days, but the experience so far has been very positive.

So one of the questions that we get to investors is just, you know, both of these products are for ADHD, and, like, how do they not cannibalize each other? So, like, what do you have? Like, maybe talk a little bit about the target patient demographics for both of these products and the use cases.

Yeah, look, great question. So before we did the deal, when we did our market research, these are two products that were already in the market. And so we wanted to understand how are physicians currently positioning these two products for their patients. For those patients where morning efficacy upon awakening is important, Jornay is a perfect match for those patients. This is what we heard back from physicians. For those patients where morning efficacy upon awakening is not an unmet need or not a stated need, But rather, these are patients that want immediate or fast onset of action, rapid onset of action that lasts up to 13 hours. They position Astaris as the more appropriate patients. When we looked at the switching data in IQVIA, both these medicines were getting their source of business primarily from generics, not from each other. So there is already an established practice in the field where physicians have figured out how they're positioning each medicine for the different patient populations. What we are now seeing is for those offices and those physicians that were prescribing one or the other, we're now able to bring the other medicine to them and frankly discuss with them how to bring this other medicine, be it journey or a status, to the appropriate patient. So we actually don't see very much cannibalization. If anything, we see our ability now to expand to a broader set of patients within the office. And that's what our research told us, and that's what I believe we will see play out in practice.

Yeah, perfect. In terms of, you know, you mentioned selling Asteris opened up, I think, 4,000 or 5,000 more offices or physicians or some sort of prescribers. And you said that doors that were closed to us before were now open. So I'm a little confused by that because they're both ADHD products. Why would one, like an office, be closed to you with Jordan Ape and that?

Yeah, I think, so what that would mean is having the second product allows us to bring something of additional value. Previously, where a physician, there are plenty of physicians out there. If you take a step back and think about Jornay, you're talking about a medicine that you have to take at night. In this entire field, there hasn't been a medicine until Jornay came along that you would take at night. So that's a change of habit. There are plenty of physicians out there who have their own habits that have been formed over a long time. Their receptiveness to hear a Jornay message may or may not have been there. But when you bring another medicine that is an astarist, which does appeal to their patient population, it does give us the opportunity to now also message them about Journey. That's what I meant by opening up doors where previously they've closed.

Okay, sounds good. So you mentioned that you had to train the sales force over the last few weeks. Maybe comment a little bit about where they all pulled from the field or staggered. I'm just curious about some of the demand over the last three weeks.

So our goal was to make sure that the harmonized sales force of 195 reps were trained as quickly as possible on both products with their – and that they were out there fully trained with their new target list. As you know, it takes a little bit of time when your targets change. It takes a little bit of time to meet your new targets, form relationships. There's a little bit of an on-ramp that has to happen for a lot of representatives. And our goal was to complete all of that as quickly as possible. Why? Because we didn't want this to take longer and eat into the back-to-school season. The back-to-school season is a really important time of the year for us to generate momentum. So any near-term disruption that you might see from, you know, people being pulled for training or otherwise, we just wanted to get that done as quickly as possible so that we went into the second half of the year with full momentum.

I guess, like, Q2 is probably the best time to do that anyway, given the seasonally...

That's exactly right. In June and July, you typically see that a bit of a lull, which is also part of the seasonality in this marketplace. Kids are out of school. So using that as an appropriate time to get all the kinks ironed out, so to speak, it lined up well from a timing perspective.

Okay. So for Asteris, you guys guided $60 million to $70 million in revenue this year for, you know, that collegiate wood book. Can you just help us understand, like, would some of that revenue fall into Q2? And then also, like, you know, what does that look like for Q3 and Q4? and how much of an inflection that we could see given that there's 195 reps out there selling the stairs relative to, I think last year it was only like $6,200 with the company that you acquired.

You want to take the revenue question and then I'll add on to that.

Yeah, absolutely. So we are providing any quarterly revenue guide, but yes, there will be revenue recorded in the second quarter from the time of acquisition on May 12th through June 30th. And so you will see that. And then, obviously, even Vikram will speak to it further. There is an opportunity to reinvigorate growth in prescriptions, and we expect to see that in the back-to-school season and beyond. I would also flag that there is a regulatory requirement to update our 8K 71 days post-close. And so at that time, the market will have insight to pro forma financials for the past few years. And so that will be a good information point for the market to just kind of see how their trajectory has gone.

Got it. Perfect. Can you talk a little bit about grossing that for Astaris and, you know, what's your expectation for this year? Because when you think about Jornay, there was some kind of improvement over time once it was in your hands. So I'm just curious if that could be a similar situation with Astaris as well.

There was. I view, as of the acquisition of Astaris, that we are catching it at a bit of an elevated gross-to-net level, similar to Jornay. Now, I don't believe that we will have as large of a magnitude of a step-down over such a short period. There were just some different dynamics in the gross-to-net stack between the two products. But we will absolutely look to optimize gross-to-nets, and we will see incremental improvements in, you know, each of the first few quarters and then really evaluate. There are not major changes to be made on the rebating or co-pay structure, but there will be the refinements that will benefit gross-to-nets overall.

Maybe a big-picture question around ADHD. So, you know, Alkermes and, you know, Lily, who acquired Synthesit, they're all fairly bullish around orexins, right, and ADHD. And there's going to be some data coming up in the second half that Alkermes is going So I'm curious to hear what your views are around, you know, orexins and how Jornay and Asteras and your portfolio would be positioned relative to that. Appreciating that the orexin class is still early, but I just wanted to hear what your thoughts are.

Yeah, you're right, Dennis. It is very early. I think the data has to play out. And look, as a practical matter, if we take a step back and think about the overall ADHD space, even though there are so many genetic alternatives, the branded medicines with appropriate patient support and everything that comes with it, we still see a lot of signs of unmet need, which is why more alternatives for patients is always going to be a good thing. And so, you know, not just the orexin class, but there are others that are looking at potentially launching medicines if they get approved, be it stimulants or non-stimulants. And overall, we think having more options for patients is a good thing. It's a large growing market, and if you look at the branded medicines, like the ones we represent, we are a very, very, very small sliver of the overall market. As far as the data is concerned, I don't know that we'd be able to comment on the data just yet because I think it just needs to play out. But there is a very well-established practice in this market of using stimulants first, as is evidence from the fact that 98 million of the 111 million prescriptions written were stimulants. And the majority of the stimulants are either methylphenidate or amphetamines and they have been around for a long, long time. So you know, could that practice evolve over a period of time? Sure, if the data pans out and if it solves an unmet need, but for the foreseeable future, We expect to continue to grow both Jornay PM as well as, in the future, Astaris, given the strong position that they both have in the market.

Perfect. So maybe a question on EBITDA. So you guys raised revenue guidance to incorporate Astaris. So I think it's 865 to 895, so that incorporates the 60 to 70 million in Astaris. But then your EBITDA guidance only went up by 20 to 25 million. So I'm curious, you know, maybe it's a gross margin dynamic because Asteris is a two-product, you know, combo pill. Or maybe there's additional sort of sales and marketing investments that you guys are making in the second half of the year. So I'm just curious how you're thinking about that, if that's fair. And how to also think about 2027 in terms of those sales and marketing expenses.

Yeah, I'd say our EBITDA adjustment, which was an increase of between $20 and $25 million, is a fair representation of what we expect this year. We expect that immediate accretion in EBITDA to accelerate as we go into 2027. You're right. It's a combination of the things you mentioned. It is gross margin, cost of production, and some selling and marketing investments. We did expand the field force very modestly, but that is a field force expansion, and we will put marketing investments behind Astaris because we believe that that is what will reinvigorate growth and really help the product see its maximum potential.

Okay. So then as we think about 2027 each week, you know, if you make some assumptions on what gross margins are, whether it's 80%, 85%, or something like that, the rest of it largely goes to sales and marketing or SG&A, right? So that's only for, you know, sorry, it's only for like half of the year. So when you annualize that, maybe that's like $40 million to $50 million next year of incremental expenses. Is that a fair way to characterize it?

It's a reasonable way to characterize it. I would say the best thing is after we get the product in our hands for a few quarters, we'll be able to give you insight and full-year guidance. You're also going to see the revenue growth trajectory tick up and gross-to-net improvement. So all those things combined, I think, will inform our 2027 guidance.

Yeah, and, you know, like you said, you're making investments right now, right, to build on that. That's right, you build on it. And your revenue is going to accelerate. And, you know, the paint business is, you know, very durable in our view. So in the last minute or two, maybe, you know, comment on BD or just, I guess, capital allocation priorities at this point.

Yep. Capital allocation priorities remain largely unchanged, I would say. You know, we've always said capital allocation is a mix of three things. it's one, investing in business development, acquiring future assets, two, paying down the debt and strengthening the balance sheet, and three, repurchasing shares opportunistically if and when it makes sense. And those three priorities remain the same. We obviously look at depending on, you know, at any given point in time, one may make more sense than the other. So at a high level, that has not changed. In terms of business development, we continue to look for ways to strengthen the portfolio. And, you know, at the right time, when we're ready to pull the trigger again, we will think about it. We've previously said that we are willing to go up to three times net debt over EBITDA for business development purposes. At the close of the Astaris acquisition, we were right about 2x. and we expect that over the next 6 to 12 months we should be given our cash generation profile we should be able to delever enough to bring it back down to that one times net debt over EBITDA so I think we will continue to look for products to strengthen the portfolio but equally important strengthen the balance sheet pay down debt and if and when it makes sense buy back shares

perfect alright well thank you so much that's all the time that we have thank you