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Transcript
OP
Operator
Operator
Greetings! Welcome to the Collegium Pharmaceutical, Inc. fourth quarter and full year 2025 earnings conference call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during this conference call, please press star zero on your telephone keypad. Please note, this conference call is being recorded. I will now turn the call over to Ian Karp, Head of Investor Relations at Collegium Pharmaceutical, Inc. Thank you. You may now begin.
IK
Ian Karp
Management
Great, thanks. Welcome to Collegium Pharmaceutical, Inc.'s fourth quarter and full year 2025 earnings conference call. I am 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 any forward-looking statements made today are made pursuant to the safe harbor provision 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. With that, I will now turn the call over to our President and CEO, Vikram Karnani.
VK
Vikram Karnani
Management
Thank you, Ian. Good morning, everyone, thank you for joining our 4th quarter and full year 2025 earnings call. 2025 was a year of transformative growth for Collegium Pharmaceutical, Inc. We delivered robust financial results due to strong commercial execution and deployed capital strategically to support long-term value creation. Importantly, we made meaningful progress on our three 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. In the 4th quarter, we saw continued momentum for Jornay among prescribers and across our key patient populations, including pediatrics, adolescents, and adults. We were encouraged to see that once again, total Jornay prescribers reached an all-time high in the quarter, which is particularly impressive given that Jornay first launched more than 6 years ago. This growth was supported by a strong back-to-school season, which began in Q3, as well as the positive impact from recent sales and marketing investments made throughout the year. In parallel, our pain portfolio continued to drive significant revenues with meaningful year-over-year growth in the fourth quarter. The continued performance of our pain portfolio enabled us to achieve record levels of both full-year total revenues and adjusted EBITDA, while generating significant cash flows to fuel our capital deployment strategy. Our dedication to patients and the communities we serve drives us every day, and it is the foundation of our success. With our achievements comes a significant opportunity and responsibility to further support patients and give back to our communities. Yesterday, we published our 2025 ESG report, which highlights the various ways we demonstrate our ongoing commitment to doing good as we do well. I encourage you to view this report now available on our corporate website. I want to thank the entire…
SD
Scott Dreyer
Management
Thanks, Vikram. Good morning, everyone. Jornay PM continued to perform well in the fourth quarter as we leveraged the momentum created in the third quarter and maximized the opportunity during back-to-school season. During the fourth quarter, we grew prescriptions, prescribers, and market share. Backed by strong brand differentiation and HCP perceptions, coupled with the growth trajectories just mentioned and our ongoing commercial investments, we are well positioned to drive additional growth for Jornay again this year. 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, including pediatrics, adolescents, and adults, report challenges starting their day, which is an area of key differentiation for Jornay as it begins working when patients wake up in the morning. In addition to efficacy upon awakening, symptom control throughout the day is important for most patients because it can eliminate the need for an additional booster at school or work. Jornay delivers efficacy that lasts throughout the day. HCP perceptions of Jornay continue to be highly positive. In market research, healthcare professionals rated Jornay as the number one ADHD brand in terms of product differentiation, with a score that was more than double that of all other medicines in the same category. In addition, over 60% of HCPs indicated a strong intent to increase prescribing, which was the highest among all other branded ADHD medicines. We also know that if a patient or caregiver specifically asks to try Jornay, physicians typically honor that request. Our commercial team remains focused on increasing awareness of Jornay's unique and differentiated profile to further drive utilization. We see opportunities to drive additional growth moving forward. In addition to raising awareness among HCPs, caregivers, and patients, other opportunities include…
CT
Colleen Tupper
Management
Thanks, Scott. Good morning, everyone. I am pleased to share that we have delivered another year of robust financial results and achieved our 2025 financial guidance. This accomplishment is a testament to the operational execution and financial discipline across our organization. Full year 2025 net revenues were a record $780.6 million, up 24% year-over-year, and adjusted EBITDA was a record $460.5 million, up 15% year-over-year. We also generated robust operating cash flows of $329.3 million and ended the year with $386.7 million in cash equivalents and marketable securities. Additional financial highlights for the fourth quarter and full year of 2025 include: total net product revenues were $205.4 million in the quarter, up 13% year-over-year, and a record $780.6 million in 2025, up 24% year-over-year. Jornay PM net revenue was $45.9 million in the quarter, up 57% year-over-year, and $148.9 million in 2025, up 48% year-over-year, compared to pro forma 2024 revenue. Belbuca net revenue was $59.1 million in the quarter, up 7% year-over-year, and $221.7 million in 2025, up 5% year-over-year. Xtampza ER net revenue was $48.6 million in the quarter, down 6% year-over-year, and $199.3 million in 2025, up 4% year-over-year. Nucynta franchise net revenue was $47.9 million in the quarter, up 15% year-over-year, and $196.3 million in 2025, up 11% year-over-year. Revenue from the Nucynta franchise increased year-over-year, primarily due to profitability improvements from managing gross to nets, consistent with our payer strategy. GAAP operating expenses were $67.6 million in the quarter, up 12% year-over-year, and $283.6 million in 2025, up 37% year-over-year. Non-GAAP adjusted operating expenses were $57.5 million in the quarter, up 13% year-over-year, and $237.3 million in 2025, up 58% year-over-year. The increase in operating expenses in 2025 reflects ongoing costs to commercialize Jornay, as well as the targeted investments we made to drive future…
VK
Vikram Karnani
Management
Thank you, Colleen. 2025 was a year of strong execution for Collegium Pharmaceutical, Inc., in which we achieved our financial commitments and delivered on our strategic priorities. We enter 2026 with great momentum and a clear focus on driving further growth for Jornay PM, maximizing the durability of our pain portfolio, and strategically deploying capital. These priorities position us to create long-term value for our shareholders as we build a leading, diversified biopharmaceutical company committed to improving the lives of patients living with serious medical conditions. I will now open up the call for questions. Operator?
OP
Operator
Operator
Thank you. We will now be conducting a question and answer session. If you would like to ask a question at this time, you may press star one from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment, please, for our first question. Thank you. The first question is from the line of Les Sulewski with Truist. Please proceed with your questions.
JL
Jeevan Larson
Analyst
Hey, this is Jeevan on for Les. Thanks for taking our questions. What assumptions underlie 2026 Jornay guidance, and how should we think about factors that could lead to upside? Have there been any competitive developments in the space that could impact Jornay demand? Thank you.
VK
Vikram Karnani
Management
Thanks for the question, Jeevan. I think, if I understood your question, you were asking what assumptions drive the 2026 guide for Jornay. As we said before in our prepared remarks, we expect that growth to be driven by demand growth, as we expect relative stability in gross to nets between 2025 and 2026. If you do not mind repeating your second question, that would be helpful.
JL
Jeevan Larson
Analyst
Yeah, sure. Have there been any competitor developments in the ADHD market that could potentially impact Jornay demand?
VK
Vikram Karnani
Management
We monitor all the typical competitive dynamics in the market. We assess future launches that might be coming into this space. To date, we do not see much material change, both in the forms of current dynamics or in future launches that could impact Jornay demand. As a reminder, Jornay remains one of the only differentiated medicines in this space, specifically because of our proprietary delivery technology, which makes meaningful impact for patients, particularly those that are dealing with morning challenges. We do not expect that to be impacted anytime in the future.
OP
Operator
Operator
Thank you. Our next question is from the line of Brandon Folkes with H.C. Wainwright. Please proceed with your question.
BF
Brandon Folkes
Analyst
Hi, thanks for taking my questions, and congrats on all the progress. Maybe just two from me. I know you have not given a peak sales range for Jornay, but can you help us frame how you are thinking about the ramp to peak? Are you thinking about a three- to five-year ramp to peak in your hands? Secondly, within Nucynta AG in the market, how promotionally sensitive is Belbuca and Xtampza at this stage of their life cycle? How do you think about the commercial infrastructure behind those products today versus perhaps if a generic came to market on either one of those? What is your hurdle to pull back on investment there? Thank you.
VK
Vikram Karnani
Management
Thanks for the question, Brandon. I will take the Jornay PM peak sales question, and then we will have Scott address the Nucynta question. You are right. We have not previously talked about Jornay PM peak sales, primarily because we have, as I said before, continued to invest in sales and marketing activities for Jornay PM. As a reminder, we expanded the sales team from 125 to 180 sales reps back in April last year, and we also said that it takes about 6 to 9 months before you can truly start to see the impact of the expansion. We are right in that timeframe right now, where we are starting to see the impact of the expanded team, and we expect that to continue throughout 2026. I think once we have a better sense of what the impact of these commercial investments tends to be, we will have a much better sense, both of the peak opportunity as well as what that ramp looks like. We look forward to keeping you updated on what Jornay looks like, both in terms of the peak and how fast we can get there. Now, on the Nucynta question, I will turn it over to Scott and Colleen to weigh in.
SD
Scott Dreyer
Management
I will start, Brandon. I think your first thing was, as Nucynta AG is here, how does that help us think about the sales force and is Belbuca and Xtampza promotionally sensitive? They are definitely mutually exclusive. Nucynta, later in life cycle, light promotional sensitivity. Belbuca and Xtampza, high promotional sensitivity. It is a different situation. It is not one where it is competitive, so to speak, versus other sales forces, but it is a highly complex marketplace. Our sales representatives are helping the offices navigate the payer environment and continue to change behavior. Definitely promotionally sensitive. We need our team, and just as a reminder, it is highly efficient. We have 100 in that sales organization that are supporting that $600 million plus revenue. We think we are in a good spot there.
CT
Colleen Tupper
Management
Yeah, Brandon, I will just add on, as we have said previously, particularly our field forces, as Scott just mentioned, are focused on Xtampza and Belbuca, and we will invest through any of those potential LOE dates because of the uncertainty. In the event an event were to occur, we can pivot pretty quickly, and we have the ability to moderate investment there, and that is how we would approach that. I might just come back and remind you on Jornay PM that the LOE for is our base case IP is out to 2032, and given its differentiation, as you think about longevity, you should be thinking about that date.
BF
Brandon Folkes
Analyst
Great. Thank you very much.
OP
Operator
Operator
Thank you. As a reminder, to ask a question today, you may press star one. The next question is from the line of David Amsellem with Piper Sandler. Please just proceed with your questions.
DA
David Amsellem
Analyst
Hey, thanks. Just a couple from me. One, on capital deployment. Vikram, I know you have talked about rare diseases in the past and certainly given your background. I am wondering how you are thinking about it in terms of acquiring a rare disease-focused asset that is on the market and using that as a beachhead off of which you can add more rare disease assets, where you would leverage a patient services and a reimbursement hub. I know that is something that obviously you have a lot of experience with, but is that something you are thinking about, or are you leaning more into your existing therapeutic areas of expertise, like psychiatry? That is number one. Secondly, just talk more generally about the Jornay sales force. There is always room to expand. ADHD is, of course, a big market, but how are you thinking about right-sizing of the sales force, or potential for more expansion down the road, whether it is this year or next year? Thanks.
VK
Vikram Karnani
Management
Thanks, David. On capital deployment, I think I will remind everyone that our capital deployment, particularly from a BD standpoint, as we have said before, the types of assets we are looking at are commercial or near commercial, primarily U.S.-based, that have LOEs into the 2030s and beyond. In an ideal world, we can get these assets in the areas where we have already made a significant commercial investment. If you think about psychiatry and pediatrics, where with the Jornay PM sales force, we already call on a significant number of prescribers. That would be ideal so we can get significant operating leverage... We have also said before that we are open to other potential areas, but they do need to be more capital efficient. As you have rightly identified, rare disease tends to be one of those areas where you can be a bit more TA agnostic, but you can build a franchise that creates operating leverage from creating a significant commercialization approach. One of them is the backbone of patient services, reimbursement hub, et cetera. As we have spoken before, both of those areas are attractive to us as we think about how we build our portfolio out for the future. In terms of the Jornay PM sales force expansion, I think what we previously said still holds true. When we expanded to 180 reps back in April, we did that because we believed that, given the number of prescribers, given what the prescribing behavior looks like and what the various deciles look like, we believed that 180 was the right number, and so we believe we are right-sized. Of course, if down the road we feel that we need to expand more, because we are only limiting our growth ourselves, then we will absolutely revisit that. At this point in time, we believe 180 is the right number, and we look forward to seeing the momentum we are going to drive this year.
DA
David Amsellem
Analyst
Okay. That is helpful. Thank you.
VK
Vikram Karnani
Management
Thank you.
OP
Operator
Operator
Thank you. At this time, I will turn the floor back to Vikram for closing comments.
VK
Vikram Karnani
Management
Thank you, everyone, for joining our call. Wish you a great rest of the day.
OP
Operator
Operator
Thank you. This will conclude today's conference. You may disconnect your lines at this time. We thank you for your participation. Have a wonderful day.