Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q1 2025 Earnings Call Transcript

Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q1 2025 Earnings Call Transcript May 9, 2025

Operator: Greetings and welcome to the Collegium Pharmaceutical First Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note that this conference call is being recorded. I will now turn the call over to Ian Karp, Head of Investor Relations at Collegium.

Ian Karp: Thanks, Maria, and welcome to Collegium Pharmaceutical’s first quarter 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, including and without limitation, the risks that we may not be able to successfully commercialize our products, that we may be – that we may incur significant expense in doing so and that we may not prevail in current or future litigation pertaining to our business.

These risks and other risks of the company are detailed in the company’s periodic reports filed with the SEC. Our future results may differ materially from our current expectations discussed today. Our earnings press release and this call will include discussions of certain non-GAAP information. You can find our 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.

Vikram Karnani: Thank you, Ian. Good afternoon and thank you for joining the call. Today, we will discuss Collegium’s first quarter 2025 financial performance and provide an update on the company’s recent progress. As Collegium embarks on a new phase of growth, we remain committed to 3 very clear strategic priorities: first, to drive significant growth in Jornay PM; second, to maximize the value of our pain portfolio; and third, to strategically deploy capital to further enhance shareholder value. I am pleased to report we have made significant progress on each of these 3 priorities in the first quarter. And importantly, these accomplishments bring us one step closer towards achieving our goal of building a leading diversified biopharmaceutical company.

Collegium was founded with an ambition to become the leader in responsible pain management and we’ve spent the past decade building a portfolio of differentiated responsible pain medicines. Today, we are the leader in responsible pain management and have also expanded our vision further as we strive to improve the lives of people living with serious medical conditions beyond pain. In fact, we have already begun to diversify our business through the acquisition last year of an important medicine, Jornay PM, for the treatment of ADHD. None of our past success would have been possible without the leadership of our Founder, Mike Heffernan, who will be retiring as Chairman of our Board of Directors in the coming weeks. I’d like to take this opportunity to formally thank Mike for his dedication to patients, his bold strategic vision and for positioning the company for continued growth in 2025 and beyond.

I’d also like to recognize our employees for the critical role that they play in our growth and success. Collegium’s dedication to fostering a collaborative, transparent and engaged culture was recently celebrated by our recognition in USA TODAY’s Top Workplaces list for the second year in a row as well as the Boston Business Journal’s Best Places to Work. I would like to extend a big thank you to our entire team for their steadfast commitment to our mission and the patients we serve. During the first quarter, we delivered strong performance, including 23% year-over-year revenue growth and significant cash flow generation. As expected, we saw the largest growth come from our ADHD medicine Jornay. In our second full quarter of ownership, prescriptions grew 24% year-over-year and generated $28.5 million in net revenue.

We continue to expect full year Jornay net revenue to be in excess of $135 million, representing at least 34% annual growth from 2024. Importantly, our business continues to be highly profitable and our ability to generate significant cash flows allows us to invest for the future. We recently completed the expansion of our Jornay sales force, adding approximately 55 new sales representatives, bringing the total ADHD sales force to about 180 reps. They are now fully trained, deployed and focused on accelerating further prescription growth. In our pain portfolio, we generated another quarter of solid revenues with $149.2 million in sales, up 3% year-over-year. All 3 of our pain medicines generated single-digit revenue growth year-over-year in line with our expectations.

In addition to these achievements, we also made important additions to our leadership team and Board of Directors, further positioning Collegium for continued success. We announced updates to our executive leadership team, welcoming David Dieter as Executive Vice President, General Counsel; Jane Gonnerman as Executive Vice President, Strategy and Commercial Development; and Dean Patras as Chief People Officer. These proven industry leaders bring a strong track record of success and will be essential as we continue to grow and diversify our business. We also announced updates to our Board of Directors. Founder and Chairman, Michael Heffernan; and Board member, Gwen Melincoff, will retire from Collegium’s Board at the Annual General Meeting on May 15, 2025; and Gino Santini, the Board’s Lead Independent Director, has been nominated to become Chairman.

Dr. Carlos Paya will be nominated to the Board and presented for shareholder approval at the AGM. These updates follow the recently announced appointment of Nancy Lurker to the Board in February 2025 and reflect the Board’s ongoing focus on Board refreshment and Board succession planning. And finally, we announced today that our Board has authorized a $25 million accelerated share repurchase program, reinforcing our commitment to return value to shareholders. As we continue to grow our business, our strategy will remain focused on driving significant growth for Jornay, maximizing our pain portfolio and strategically deploying capital to create value for our shareholders. Jornay is highly differentiated as the only stimulant ADHD medicine with convenient evening dosing.

Jornay provides symptom control upon awakening in the morning and throughout the day, limiting the need for an additional booster. Our targeted investments throughout 2025, including our expanded sales force and marketing efforts, position Jornay for both near-term growth and significant momentum in 2026 and beyond. We also remain dedicated to maximizing and enhancing the durability of our pain portfolio to generate significant operating cash flows. As evidenced by our first quarter performance, including year-over-year revenue growth for Belbuca, Xtampza ER and the Nucynta franchise, the pain portfolio continues to provide a strong financial foundation for the company. We are confident in the durability of our pain medicines and their ability to continue to drive cash generation.

Our third priority is to strategically deploy our capital as we seek to further grow our business and create value for shareholders. We are focused on diversifying and expanding our portfolio of medicines through disciplined business development, rapidly paying down debt and opportunistically repurchasing shares. In the first quarter, we generated $55.4 million in cash from operations, growing our cash position to nearly $200 million, which is up $35 million from year-end, while also paying down an additional $16.1 million of debt. In terms of future business development, as we continue to assess potential external opportunities, we do so from a position of financial strength. This is especially important given the broader political and economic pressures occurring right now within the overall healthcare sector.

Before I turn the call over to Scott to give a more detailed commercial update, I’d like also to provide a bit of context regarding the potential impact of tariff policies, both here in the U.S. and across the globe. We do not expect recently announced tariffs to impact Collegium’s business in any material way for the foreseeable future. All of our medicines are primarily sourced and manufactured in the U.S. In addition, the overwhelming majority of our medicines are sold exclusively in the U.S. 2025 is shaping up to be an exciting year for Collegium and we look forward to providing additional updates as the year progresses. With that, I will now turn it over to Scott.

Scott Dreyer: Thanks, Vikram, and good afternoon, everyone. Jornay is off to an extremely strong start to the year, a clear continuation of the positive momentum we generated in 2024. And importantly, recent script growth was accomplished in advance of our field force expansion and any new commercial initiatives we’re deploying through the remainder of the year. Underpinning this growth is Jornay’s highly differentiated product profile. It’s the only stimulant ADHD medicine with once-daily evening dosing that provides symptom control upon awakening through the afternoon and into the evening, which can limit the need for short-acting stimulant add-ons. This is important for pediatric, adolescent and adult patients because it eliminates the need to dose throughout the day at school or at work.

In fact, in market research, HCPs ranked Jornay as the #1 recognized brand, both for achieving all-day symptom control with 1 dose and for controlling evening symptoms after school or work. Jornay is also the highest rated brand in terms of product favorability. And when patients and caregivers request to try Jornay, HCPs honor that request. We plan to further leverage this dynamic through targeted marketing efforts for the remainder of the year. The first quarter of 2025, our second full quarter of Jornay ownership, was marked by significant prescription growth. This growth was particularly impressive when you consider the typical first quarter headwinds that can impact branded drugs in the highly genericized ADHD category as annual patient deductibles reset and out-of-pocket cost to patients increase.

In fact, prescriptions during the quarter grew 24% year-over-year and Jornay’s market share of the long-acting branded methylphenidate market increased to 20.3%, up 6.4% year-over-year. Importantly, Jornay has broad and growing prescriber base with over 25,000 prescribers in the first quarter, up 22% compared to the first quarter of 2024. This growing base of prescribers is a further testament to the impact of our sales force as they work to educate the healthcare community on Jornay’s differentiated profile. We see significant additional opportunities for Jornay and are committed to investing in the brand to maximize its full potential. We’ve identified 2 main areas to make targeted investments. First, increasing awareness and adoption within an expanded set of prescribers.

Second, raising awareness of Jornay’s unique and differentiated profile among patients and caregivers to drive HCP requests. Let’s start with the primary action we are taking to raise awareness and adoption among healthcare providers. We recently completed the expansion of our sales force, adding approximately 55 new representatives who are fully trained and deployed as of April. Our expanded sales force, which is now 180 representatives, is targeting approximately 21,000 prescribers, up from 17,000 targets prior to our expansion. We expect our expanded sales force to drive increased adoption of Jornay and generate prescription growth in line with our guidance for the year. We expect to realize the full impact of the expanded sales force in 2026 and beyond.

In addition to expanding the reach of our sales force, we believe it’s important to further educate patients and caregivers on the unique benefits of Jornay. Market research indicates patient and caregiver requests are a top influencer of HCP trial. And today, patients and caregivers still have limited knowledge of Jornay and its differentiated profile. To raise awareness, we’re launching new digital marketing and social media initiatives, along with new patient support materials, all designed to motivate patients to speak with their healthcare providers about Jornay. We’ll launch these new campaigns in advance of the back-to-school season. With Jornay’s current prescription and prescriber growth trajectory, strong market access coverage and targeted investments, Jornay is well on its way to becoming Collegium’s lead growth driver in 2025 and beyond.

Collegium has a history and reputation of being the leader in responsible pain management with a unique and differentiated portfolio of medicines. Belbuca, Xtampza and Nucynta ER collectively represent over half of the branded ER market, demonstrating the ongoing strength and reach of our portfolio. Our pain portfolio delivered another strong quarter, right in line with our expectations. Total revenue growth for the portfolio was 3% year-over-year with all 3 medicines generating low-single-digit revenue growth. As expected, total prescriptions across the pain portfolio were pressured by both typical first quarter dynamics where deductibles reset and out-of-pocket costs increase for patients as well as recent formulary changes impacting individual brands.

However, these script declines were in line with our expectations and offset by profitability improvements, which led to overall revenue growth in the quarter. Importantly, the business is performing as expected and continues to show great durability. While the overall pain market continues to decline in line with our expectations, we continue to see that there’s ample market opportunity for our portfolio of differentiated medicines. For example, Belbuca remains the only long-acting opioid that uses buprenorphine buccal film technology. In market research, it was ranked as the #1 branded ER opioid in terms of product differentiation and favorability. Similarly, Xtampza, the only extended-release oxycodone medicine that uses our proprietary best-in-class abuse-deterrent technology, DETERx, was ranked as the #1 ER oxycodone medicine in terms of product differentiation and favorability.

We continue to believe that the revenue and cash flows generated from our differentiated pain portfolio will remain durable in both the near and mid-term. Importantly, we believe the life cycle of these medicines may prove to be longer and more robust than is currently appreciated by the market. Xtampza, for example, does not lose exclusivity until September of 2033. And the exclusivity for Nucynta ER and Nucynta IR were recently extended to July of 2027 and January of 2027, respectively. Overall, I’m proud of our commercial execution so far this year, which includes generating impressive growth for Jornay, completing the expansion of our ADHD sales force and delivering solid performance with our core pain business. We remain well positioned to deliver on our commercial priorities for 2025 and to support our next phase of growth.

I’ll now hand the call over to Colleen to discuss financial highlights.

Colleen Tupper: Thanks, Scott. Good afternoon, everyone. In the first quarter of 2025, we delivered strong financial results, including growing revenue 23% year-over-year, making targeted investments in our lead growth driver, Jornay, and generating strong cash flows from our pain business. Financial highlights for the first quarter of 2025 include net product revenues were $177.8 million, up 23% year-over-year. Jornay net revenue was $28.5 million, which represents our second full quarter of ownership. Belbuca net revenue was $51.7 million, up 2% year-over-year. Xtampza net revenue was $47.6 million, up 4% year-over-year. And Nucynta franchise net revenue was $47.1 million, up 4% year-over-year. GAAP operating expenses were $75.6 million, up 80% year-over-year.

Non-GAAP adjusted operating expenses were $62.2 million, up 80% year-over-year. The increase in operating expenses reflects ongoing costs to commercialize Jornay as well as the targeted investments we’ve made to drive growth, including the expansion of our sales force. GAAP net income was $2.4 million compared to net income of $27.7 million in the first quarter of 2024. As a reminder, net income in the first quarter was impacted by expenses associated with the Ironshore acquisition as well as executive transition expenses that do not represent ongoing operations. Non-GAAP adjusted EBITDA was $95.2 million, up 3% year-over-year. GAAP earnings per share was $0.08 basic and $0.07 diluted in the first quarter compared to GAAP earnings per share of $0.86 basic and $0.71 diluted in the prior year period.

Non-GAAP adjusted earnings per share was $1.49 in the first quarter versus $1.45 in the first quarter of 2024. Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. In addition, we generated $55.4 million in cash from operations and ended the quarter with $197.8 million in cash, cash equivalents and marketable securities as of March 31, up $35 million from the end of the year. We are reaffirming our 2025 financial guidance. We expect net product revenues in the range of $735 million to $750 million, an 18% increase year-over-year. This increase is primarily driven by Jornay, which we expect to generate net revenue in excess of $135 million, supported by continued performance across our pain portfolio.

We expect adjusted EBITDA in the range of $435 million to $450 million, representing 10% growth year-over-year and adjusted operating expenses in the range of $220 million to $230 million. The growth in adjusted operating expenses reflects targeted investments to support Jornay near-term growth and drive significant momentum in 2026 and beyond. We expect quarterly adjusted operating expenses to trend down in the second half of the year. We remain committed to strategically deploying capital to create value for our shareholders as demonstrated by our targeted investments in Jornay to accelerate growth, continued focus on evaluating opportunities to expand our portfolio through business development and rapid repayment of debt. We also have a strong track record of returning value to our shareholders through share repurchases and our Board recently authorized a $25 million accelerated share repurchase as part of our $150 million program.

We ended the first quarter with net leverage of 1.5x net debt to EBITDA and we expect to end 2025 with net leverage of less than 1x. We repaid $16.1 million of our term loan this quarter and expect to repay an additional $48.4 million during the remainder of 2025. I will now turn the call back to Vikram.

Vikram Karnani: Thanks, Colleen. We are proud of our strong performance in the first quarter. We generated stable cash flows from our pain portfolio, drove impressive growth in Jornay, strengthened our balance sheet and made investments to fuel our next phase of growth. We are on track to achieve our 2025 financial guidance and look to the future beyond 2025 from a position of financial strength. We remain focused on creating shareholder value and the strength of our balance sheet gives us the flexibility to maximize and grow our existing portfolio of differentiated medicines, while also prioritizing further diversification through disciplined business development and returning value to shareholders through share repurchases.

With Jornay well on its way to becoming our lead growth driver, supported by the long-term durability of our pain portfolio and an industry-leading executive team, we are confident as we enter our next phase of growth. Ultimately, our greatest success will be our ability to improve the lives of people living with serious medical conditions. I will now open the call up for questions. Operator?

Q&A Session

Operator: [Operator Instructions] Our first question comes from Les Sulewski with Truist Securities. Please proceed with your question.

Les Sulewski: Good evening. Thank you for taking my questions and congrats on the progress. So, I have a couple for Scott and then one for Vikram. Scott, so as we are heading to the tail end of the school year, how would you expect the Jornay scripts to trend before the new kind of season pick-up given the recent investment in the sales force? And then also touching on the sales force, is this an increasing touch points or is this more about a geographic expansion? And I have a follow-up to that.

Scott Dreyer: Thanks for the question, Les. So, first to your question about seasonality, so yes, so there is an overall seasonality in the marketplace. So, essentially, what you will see when you look at weekly scripts is as we get to the May – end of May, June time period, depending on where you are in the country, there can be a little bit of a slowing of scripts a bit in the overall market because some people will have their child take a little bit of a holiday during the summer from their prescriptions. That then precedes the acceleration you see in back-to-school season, which hits usually in the mid-August time period and then carries well into the fall, last year carried to the beginning of December. So, that’s the seasonality you should expect when you look at the overall market in ADHD.

When it comes to our expansion, yes, there is multiple levers that we pulled. So, first, in terms of touch points, we increased our target universe from about 17,000 healthcare professionals to 21,000. So, we are reaching more. But with the expansion of 55 and going from 125 to 180 reps, it wasn’t just about an increased reach to those new targets. It was also about increasing our frequency on the current targets. So, overall, what we are looking to see is through expanded reach and frequency, greater understanding of Jornay, greater adoption of Jornay. And from a script standpoint, as I have shared before, really seeing the impact start to kick in, in about six months is what typically you see in terms of acceleration of scripts. So, we have that more fourth quarter and then into 2026 and beyond.

Les Sulewski: That is helpful. And then looking beyond methylphenidate, is there an opportunity to utilize the Jornay PM delayed release technology and potentially apply to additional compounds, for example, Adderall or Modafinil? Have these conversations occurred internally? And what will be some of the required steps to push this through if this were the case?

Vikram Karnani: Yes. I will take that one, Les. Those conversations, I believe I think occurred even before the acquisition happened. So, Ironshore had already explored using their technology for other compounds. And I believe the result of all of that work is the fact that we have Jornay, which is – which worked really well, the technology worked really well for methylphenidate.

Les Sulewski: Got it. Okay. And then, Vikram, maybe touch on a little bit on the recent color around potential BD plans given your are – you have kind of seeded now at Collegium. What’s kind of the appetite for a deal? And has the current change in the environment kind of impacted your outlook for potential deals? Thank you.

Vikram Karnani: Yes. Great question. I think as we stated in our prepared remarks, we always look at capital deployment in a very strategic way for the company. And I think we have been consistent in our position that we will do the right thing to create value for our shareholders and that’s a combination of business development, if it’s the right time and the right deal, it’s we are paying down debt, which you have seen us do, and opportunistically repurchasing shares and returning value to our shareholders, which is exactly what we talked about today. So, I would expect that, that type of approach, that type of discipline will continue. And as far as your question about this particular market environment, does it increase or change our likelihood of getting a deal done.

I don’t know that I would make a comment specifically around that. I think whether it’s this environment or otherwise, we are – as I have said before, we look to expand our portfolio of medicines. But I think we are going to do it in a very disciplined way, which is a strong track record that Collegium has had. Go the next question?

Operator: Our next question comes from Serge Belanger with Needham & Co. Please proceed with your question.

Serge Belanger: Hi. Good afternoon. A couple of Jornay questions for Scott. I guess the first one, can you remind us what the overall ADHD market growth has been recently? And secondly, also remind us the breakdown in the prescriber base between pediatrician and psychiatrists? And then lastly, you did highlight market share seeing some significant gains over the last year. Just curious where that market share is coming from? Is it from other branded products or really other generics in the ADHD market?

Scott Dreyer: Alright. Serge, you gave me a few of them there. Alright. So, let’s start with market growth. Yes, the market is growing at about 5% to 6% overall. That’s been pretty consistent for the last few years and that’s where we expect the growth to continue going forward. When you look at the prescriber base, it’s pretty straightforward. It’s roughly 40% is pediatrician. The other 40% is neuropsychiatry. Some of those are Ped Neuropsychiatrists. And the remaining 20% is about half PCP and about half NPs or PAs, mid-levels that ladder up to the specialties. So, that’s the prescriber base that we are looking at there that drives the market and who we are focused on in our target audience. And then lastly, from a share perspective, yes, we have seen really strong share growth, right, growing to 20% this year year-over-year in the long-acting branded methylphenidate market.

And basically, the biggest feeder of growth is the movement from generic immediate release products, right. That’s the biggest feed to the branded products and that’s what we see. And then we do get some switching from other branded products, but it’s mostly the generic immediate release that feeds our business.

Serge Belanger: Thank you.

Operator: Our next question comes from David Amsellem with Piper Sandler. Please proceed with your question.

David Amsellem: Thanks. Just a few on my end. First, how large of a sales organization at steady state are you contemplating for Jornay PM, if I recall, when Vyvanse had exclusivity, Shire’s sales force was quite large, a good bit larger than what you have now. I am not saying that you are going to go there, but there obviously is a wide prescriber audience in the ADHD space. So, how are you thinking about that? Secondly, can you share your views on what kind of peak sales range you think is realistic for Jornay PM? And then lastly, a biz dev question. How large of a transaction could you contemplate given the current state of the capital structure? Thanks.

Vikram Karnani: Yes. Thanks, David. Scott, why don’t you take the first question? I will take the question on peak sales. And then between Colleen and I, we will answer the last one.

Scott Dreyer: Yes, that’s great. So, yes, so thanks for the question, David. On the sales force, look, we sized that 180 because that’s the right size now. We did a bottom up. We didn’t have any constraints. That’s reaching a target audience. That’s the right target audience to drive the brand with the right level of reach and frequency, having really productive territories. So, that’s what led to where we are right now. So, we evaluate that on a regular basis. Every year as part of our planning process, we will be looking at that, looking at the sales force, seeing if we need to make any adjustments on the edges. But that’s what the business demands right now. And to your Vyvanse comment, I think the big difference is that was such a highly branded and competitive marketplace.

Now, if you look – where you see such genericization, right, we really have only a couple of players that we are competing with for share of voice. And so not only are we reaching the right customers, but we also feel like we have a really strong share of voice out there in the branded market.

Vikram Karnani: The second question I think, David, you had was around peak sales for Jornay. We have not talked about peak sales for Jornay PM externally. Part of the reason is we have just gone through an expansion and we have only owned the medicine now for two quarters. What we would like to do is see the impact of the expansion, which as you can imagine, there is a bit of a lag time between folks going into the field and seeing the downstream effect on demand. I think once we have a better sense of the impact of the expansion, it will give us a sense of the trajectory and we will be in a much better place to talk about peak sales at that time. And I think that your last question was about what would be the size of a biz dev transaction that we would contemplate at this time.

Maybe I can begin and I will have Colleen provide some additional color. But we – I don’t know that we have necessarily talked about size of transaction. I think what we have talked about is our ability to take on leverage if we need to. So, in terms of capacity, I think we have talked about the fact that last year, we ended with our net debt over EBITDA at about 1.8, 1.9. This quarter, we are already down to about 1.5 and we expect to end the year less than one. So, what I can say is that we – given the situation, given our ability to generate significant cash flows from operations, we feel that gives us enough capacity to do a meaningful transaction if the transaction comes along. We are not going to do a deal just to do one, but it’s got to be the right one.

And Colleen, anything else you would add?

Colleen Tupper: I think that’s right. I think the right deal for the right terms, we have sized from a debt perspective, we would be willing to potentially go up to 3x for a commercial asset. What you don’t have in that equation is what does the target bring for EBITDA, so we consider that as we are evaluating.

David Amsellem: Okay. Thank you.

Operator: There are no further questions at this time. And I would now like to turn the floor back over to Vikram for closing comments.

Vikram Karnani: Thank you everyone for joining the call today. I wish everybody a great evening.

Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.