Greetings, and welcome to the Collegium Pharmaceuticals Second Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note, this conference is being recorded. I'll now turn the conference over to Ian Karp, Head of Investor Relations at Collegium. Thank you. You may now begin your presentation.

Great. Thanks, and welcome to Collegium Pharmaceuticals Second Quarter 2025 Earnings Conference Call. I'm joined today by Vikram Karnani, our President and Chief Executive Officer; Colleen Tupper, our Chief Financial Officer; and Scott Dreyer, our Chief Commercial Officer. Before we begin today's call, we want to remind participants that none of the information presented today is intended to be promotional and that any forward-looking statements made today are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such forward-looking statements involve risks and uncertainties as detailed in the company's periodic reports filed with the Securities and Exchange Commission. Our future results may differ materially from our current expectations discussed today. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations on our corporate website. And with that, I'll now turn the call over to our President and CEO, Vikram Karnani.

Thank you, Ian. Good morning, everyone, and thank you for joining the call. Today, we will discuss Collegium's second quarter 2025 financial performance and provide an update on our recent progress. At Collegium, we are dedicated to building a leading diversified biopharmaceutical company focused on improving the lives of people living with serious medical conditions. This past quarter, we continued to execute our strategic priorities, which include driving significant growth for Jornay PM, maximizing the durability of our pain portfolio and strategically deploying capital to further enhance shareholder value. We generated both top and bottom line growth in the quarter, including record revenue from Jornay and returned value to our shareholders through our share repurchases. As we look ahead to the second half of the year, we remain committed to the patient communities we serve. The continued strength of our commercial and financial performance provides significant flexibility to further grow and diversify our business. We will continue to evaluate external opportunities to expand our portfolio through business development and generate shareholder value through our capital deployment strategies. We are well positioned for our next phase of growth, and I am confident in our ability to deliver on our financial and strategic commitments. I would like to thank all of our employees for their continued dedication to our mission and to the patients we serve who are at the center of everything we do. In the second quarter of 2025, we delivered strong financial performance, including record quarterly revenue that grew 29% year- over-year and adjusted EBITDA that grew 9% year-over-year. This was driven by performance across our entire portfolio, including from our lead growth driver, Jornay. During our third full quarter of owning Jornay, prescriptions grew 23% year-over-year, and we generated record quarterly revenues of $32.6 million. We also generated…

Thanks, Vikram, and good morning, everyone. In the second quarter, we continued to see strong momentum from our lead growth driver, Jornay PM. Jornay is a highly differentiated medicine and the only ADHD stimulant with once-daily evening dosing that provides symptom control upon awakening through the afternoon and into the evening. Many patients and caregivers report challenges starting their day, which is an area of differentiation for Jornay as it begins working when patients wake up in the morning. One of the key insights identified in recent market research was that many adult ADHD patients cite the morning as a challenging time, highlighting the need and importance of morning efficacy for all patient populations, not just children and adolescents. Conversely, many HCPs underestimate the need for morning efficacy among adult patients. This calls attention to a disconnect between patient need and HCP perception and provides us with an additional opportunity to raise awareness among HCPs in the future. In addition to efficacy upon awakening, symptom control throughout the day is important for all patient types, pediatric, adolescent and adult because it can eliminate the need for additional boosters at school or work. HCP perceptions of Jornay are strong. In another body of recently completed market research, health care professionals rated Jornay as the #1 ADHD brand in terms of product differentiation with a score that was more than double that of any other competing brand. In addition, over 60% of HCPs indicated a strong intent to increase prescribing, which was the highest among all other branded ADHD medicines. Since we acquired Jornay, we've also made steady progress in raising awareness and adoption among HCPs. And from market research, we know that if a patient or caregiver specifically asked to try Jornay, physicians typically honor that request. Importantly, there is still…

Thanks, Scott. Good morning, everyone. We delivered strong financial results in the second quarter, growing revenue 29% and adjusted EBITDA 9% year-over-year, while making targeted investments to drive continued growth in Jornay PM we generated robust operating cash flows of $72.4 million and executed our capital deployment priorities, including returning $25 million of value to shareholders through share repurchases and repaying $16.1 million of debt. Our strong performance enabled us to raise our 2025 financial guidance, which I will detail shortly. Financial highlights for the second quarter of 2025 include net product revenues were $188 million, up 29% year-over-year. Jornay net revenue was $32.6 million. Belbuca net revenue was $52.6 million, up 1% year-over- year. Xtampza net revenue was $52.6 million, up 18% year-over-year. Xtampza revenue for the second quarter did benefit from the timing of rebate settlements in the quarter. Nucynta Franchise net revenue was $46.4 million, up 4% year-over-year. GAAP operating expenses were $73.3 million, up 69% year-over-year. Non-GAAP adjusted operating expenses were $61.9 million, up 104% year-over-year. As a reminder, the increase in operating expenses reflects ongoing costs to commercialize Jornay as well as the targeted investments we've made to drive future growth, including the expansion of our sales force and recently launched marketing campaigns. GAAP net income was $12 million compared to net income of $19.6 million in the second quarter of 2024. Non-GAAP adjusted EBITDA was $105.1 million, up 9% year-over-year. GAAP earnings per share was $0.38 basic, $0.34 diluted compared to GAAP earnings per share of $0.60 basic and $0.52 diluted in the prior year period. Non-GAAP adjusted earnings per share was $1.68 versus $1.62 in the prior year period. Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. In addition, we generated $72.4 million in cash…

Thanks, Colleen. We are pleased with our strong performance and execution of our strategic priorities during the first half of the year. We expanded awareness of Jornay, grew revenues for both Jornay and our pain portfolio, achieved bottom line growth and generated significant cash flows while also returning value to our shareholders. Our increased guidance ranges for revenue and adjusted EBITDA reflect our strong financial position and our continued confidence in the performance of our differentiated medicines. Looking ahead, we expect to benefit from the impact of our targeted investments in Jornay as well as durable performance from our pain portfolio. We remain focused on our capital deployment strategy to further expand and diversify our business while creating value for our shareholders. And importantly, we remain committed to improving the lives of patients suffering from chronic pain and ADHD. I will now open the call up for questions. Operator?

[Operator Instructions] And our first question is from the line of Les Sulewski with Truist Securities.

A couple for me. So what's the target goal for the number of additional prescribers that you expect for Jornay PM by the end of the year? And I guess, what percentage of the targeted prescriber base are already familiar with Jornay PM? And then maybe provide some additional color, if you could, around the progress on tapping into that adult population. And lastly, on Jornay, now that you're comfortable with the path for Jornay PM and the growing base of that product, how that's progressing, have you considered revisiting the $300 million to $400 million peak sales estimate? And then I have a follow-up.

Yes. Les, thank you for the questions. I'm going to let Scott take -- answer most of the questions on Jornay commercial performance. Maybe before I turn it over to Scott, let me just address the 300 to 400 the peak sales number for Jornay. As we've said before, what we'd like to do is see the impact of the performance of the expanded sales team of the targeted investments we're making in new marketing campaigns, then we can determine what the appropriate number would be. So we will revisit it at that time. And with that, I'll turn it over to Scott to address the other Jornay-related questions.

All right. Thanks, Les. So I'm going to try to catch them all here. So first, in terms of prescribers, I wouldn't say that we have a goal for prescribers. What we're focused on is continued breadth of prescribing. So the important thing is 26,000 this quarter, that's up 23% year-over-year. There's no sign of slowing down. We're seeing prescribers added regularly, and we would expect that to continue, frankly, for quite a few years to come. Remember, overall prescribing in this market, it's about 20,000 that drive 1/3 of prescribing, but there's hundreds of thousands of prescribers overall. So we'd expect that to continue to grow given our strong market access. In terms of awareness, we're continually trying to raise awareness. Where Jornay sits right now is it has strong awareness. In the recent ATU that I referred to, unaided awareness was just north of 50%. That only trailed Vyvanse and Concerta. So we're encouraged by that, but that also signals the room we have to go to continue to raise awareness. The adult question, really good question. A couple of things I want you to understand about adult, right, and the adult business. First, it's a large market and it's growing. Second, already Jornay has 20% of its business with adults. We know that methylphenidate overall skews towards use in pediatrics and is about 70-30. Jornay is at 80-20. So we expect it to continue to move in that direction. But there's key insights I mentioned related to the market research. What we're learning is the value proposition of Jornay is just as important to adults as it is to children or adolescents. Efficacy upon awakening throughout the day and into the evening is important for both patient types. And when you look at our 23% growth this quarter, the growth by type is this. We grew 21% in [indiscernible]. We grew 33% in adult. So we're growing across patient segments. We see opportunity within adult, and we'll continue to leverage that profile of Jornay to grow in both populations. So I hope that helps, Les.

Very helpful. And as my follow-up, maybe spend a little time, if you could, about further investments across the pain portfolio.

Yes. Thanks, Les. Again, I'll turn this over to Scott to talk about how we're supporting the growth in the pain franchise, which has turned out to be a very nice durable source of revenue for the company. Go ahead, Scott.

Yes, thanks. So in terms of investment on the pain business, I think what's great about it is it's a very durable business. And the investments we're making now are sound. So we have about 100 salespeople. Every year as part of brand planning, we check in on targets and what we need from an investment standpoint, and that's consistent. And so I don't see anything moving up or down related to those investments. Same with marketing, consistent spend, raising awareness, engaging HCPs. But again, we don't market directly to consumers on the pain opioid side. So those maintain kind of a steady lower spend compared to Jornay.

Next questions are from the line of Serge Belanger with Needham & Company.

This is John on for Serge today. Just wanted to touch on Jornay again here. So you expanded the sales force recently and you're now entering the busy season. Just wanted to gauge what's some of the specific levers are that you're looking to pull throughout the third quarter here that can really deliver and help out the top line. Also on the pain portfolio, you've mentioned improved durability across all 3 of the products. Just curious if anything has developed on the generic competition front, whether any recent ANDAs have been filed or whatnot?

Thanks, John. Appreciate the questions. I'll turn it over to Scott to address both on the Jornay and the pain side. Go ahead, Scott.

All right. So first, starting with the expansion. I'll just reinforce, the expansion is going really great. We're seeing great early indicators. We're reaching more targets at a greater frequency. And I think the key thing is in the second quarter, we saw 2,700 of those new targets wrote a prescription. So on track, heading where we expect it to be. In terms of levers in the third quarter and the back-to-school season, I'll reinforce what I said in my prepared remarks. This is all about two things: continuing to raise awareness among HCPs when it comes to acceptance and adoption of Jornay more broadly across their patient types and about raising awareness among caregivers and patients to drive them into the physician's office to ask about Jornay. What we know is when a physician is asked by a patient to try Jornay, they honor that request. And so we're excited about that. The back-to-school season is here, and we expect to see acceleration over the next few months. In terms of durability, we don't have any new updates in terms of durability of our profile, but I'll turn it over to Colleen if she wants to give any other color on generic entries and the durability.

Sure, John. Maybe I'll just give a reminder across the pain franchise that there is no party that has the necessary combination of all the ingredients needed to launch, and that would be regulatory clearance, legal clearance and manufacturing capability to launch competitive generics against any product in our pain portfolio. Specifically, I'll touch upon sort of the near-term questions, which are Belbuca and Nucynta. For Nucynta, Teva is the earliest potential entrant in January 2027 as they had previously entered in a settlement for that date. However, they do not have tentative approval and have relinquished their first filer exclusivity. Further, based on their own public statements, they may have a strategy that has shifted away from these types of products, lower volume and particularly in the opioid space. Alvogen is currently barred from the market until December 2032. And then the last ANDA filer on Belbuca is Chemo, and they have no approved product, and we have received 5 CRLs to date. So then if I shift gears to Nucynta, there are several ANDA filers across the franchise. However, based on our understanding, all potential entrants lack access to commercial scale quantities of tapentadol. And the only DMF producing at commercial scale is our exclusive supplier. So as a reminder, those potential dates for Nucynta are Nucynta IR at January 2027 and Nucynta ER at July 2027. But the question really becomes, will anyone have access to commercial scale. So we do see a longer and more robust tail possible with the pain franchise. Thanks for the question.

The next question is from the line of David Amsellem with Piper Sandler.

So a couple for me. First, Vikram, in your opening remarks, you described Collegium more expansively, -- in other words, not as a pain-focused company, not as a CNS-focused company. So I guess that sort of leads me to wonder the following, which is, how are you thinking about the kind of assets you're looking for regarding M&A or business development? And does that mean that you're not wed to pain/CNS? So that's number one. Number two is, are you squarely focused on a commercial stage asset or assets? And then as a corollary to that, at what point do you start considering a late-stage asset and ultimately with the idea of building a pipeline?

Thanks, David. I appreciate the question. I think in my prepared remarks, I described us as a leading diversified biopharmaceutical company. And I think that definition has -- we've been consistent with that. And I think we remain consistent with that. With that said, we continue to assess a wide array of potential BD opportunities. But I think we -- as I've said before, we remain very committed to being disciplined in our approach. I think as we have described before, we like the idea of leveraging our existing position within pain as well as within ADHD or psychiatry. As I've said before, with Jornay, we call on psychiatrists as well as pediatricians. So to the extent that we can leverage our investments and our infrastructure that is already in place, that would be our ideal target from a BD perspective. Again, with that said, we've also previously stated that we remain open to other ideas. But if we step outside of those two areas, we need to be extremely financially disciplined so that we're not giving up significant margin profile just for the sake of revenue. So I think no real change from what we have stated before as we look at the type of assets for BD. Your question -- your second question was around looking at noncommercial assets. I think we, again, consistently said that our focus is on commercial assets or, let's just say, commercial-ready assets, right? With the goal of reducing risk as much as possible. I think once we're at a point where we have expanded our commercial portfolio and we've gained a little bit more scale and size, I think down the road, we will -- we can revisit the idea of adding more pipeline or development stage assets. But I don't think we're necessarily at that stage yet.

At this time, there are no additional questions. Vikram, would you like to make some closing remarks?

Yes. I think just in closing, thank you, everyone, for joining the call this morning, and enjoy the rest of your day.

This will conclude today's conference. Thank you for your participation. You may now disconnect your lines at this time.