Participants

Scott Dreyer; Executive Vice President, Chief Commercial Officer; Collegium Pharmaceutical Inc

Colleen Tupper; Chief Financial Officer, Executive Vice President; Collegium Pharmaceutical Inc

Leszek Sulewski; Analyst; Truist Securities

David Amsellem; Analyst; Piper Sandler & Co.

Presentation

Operator

Greetings and welcome to the Collegium Pharmaceuticals, fourth quarter in full year 2024 earnings conference call.
(Operator Instructions)
Please note that this conference call is being recorded. I'll now give a call over to Danielle Jesse, the director of Investor Relations at Collegium.
Thank you and you may begin.

Welcome to Collegium Pharmaceuticals fourth quarter and full year 2024 earnings conference call. I am joined today by Vikram Karnani, our President and Chief Executive Officer, Colleen Tupper, our Chief Financial Officer, and Scott Dyer, 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 harbour provision of the Private Securities Litigation Reform Act of 1,995.
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 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 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 at collegium Pharma.com.
I will now turn the call over to our President and CEO, Vikram Karnani.

Thank you, Danielle. Good afternoon and thank you everyone for joining the call. Today we will discuss Collegium's financial performance for the fourth quarter and full year 2024 and provide a business update. Let me start by saying how thankful I am for the opportunity to join Collegium at this exciting time in the company's Journey having spent the last several years leading high growth organizations, I'm energized at the opportunity to spearhead this team through its next phase of growth.
Collegium has a successful track record of creating value through strong commercial execution and strategic acquisitions, all while maintaining financial discipline. The organisation's commitment to improving the lives of people living with serious medical conditions and its strong culture are what attracted me to this role. The company has built a leading paint portfolio that generates strong cash flows which enables investment in future growth, and the iron shore acquisition demonstrates that Collegium is well positioned to make further investments that leverage our expertise and will drive a new phase of growth for the company.
With Jornay poised to be Collegium's lead growth driver, the company is at an inflection in its growth trajectory. We have strong leadership and a deeply committed team of employees, and I am looking forward to collaborating with this accomplished team, working together toward our goal of building a leading diversified biopharmaceutical company.
At Collegium, we strive to do good as we do well, and our values are highlighted in our 2024 ESG report that was published yesterday. I'd like to recognize the entire team for our commitment to Collegium's mission and for helping make a positive impact on the people and the communities we serve. 2024 was a transformational year for collegium. We generated significant growth in our portfolio through strong operational execution.
The robust, durable cash flows generated by our paint business enabled us to acquire Ironshore therapeutics and its lead medicine Jornay APM, establishing a new presence in neuropsychiatry. Jornay's growth accelerated during our first full quarter of ownership. In the fourth quarter, we grew prescriptions 29% year over year and 11% quarter over quarter.
Jornay net revenue on a pro forma basis was $100.7 million in 2024 and is expected to be in excess of $135 million in 2025, representing over 34% growth. Our pain portfolio generated 5% revenue growth in 2024, led by record revenues for both BELBUCA and [ExamA]. We achieved our financial guidance for the year, growing total revenue 11%, while adjusted EBITDA to 9% year over year.
We opportunistically repurchased $60 million worth of shares in 2024. We strengthened the durability of the Nucynta franchise with several positive developments that extended projected exclusivity for Nucynta to July 2027, reinforcing this franchise as a robust revenue contributor this year and beyond.
We appointed Nancy Lurker to our board of directors. Nancy's expertise in driving commercial growth and strategic acquisitions will be of great value to us as we work to advance our mission. We warmly welcome Nancy to the board. And finally, I'm excited to welcome our new head of investor relations, Ian Korp, to the collegium team.
Ian has a long history of leading investment relations for a number of leading biopharmaceutical companies, and we are thrilled that he has joined us for our next chapter of growth. As we look to 2025 and beyond, we will build on the momentum we generated across our commercial portfolio in 2024 and focus on three main priorities.
The first is to drive significant growth in Jornayey to maximize its potential as an important therapy for the ADHD community. Jornay is a highly differentiated medicine for the treatment of ADHD and has potential for significant growth with the right investments. We've identified opportunities to raise awareness of Jornayey with healthcare professionals, patients, and caregivers, and we'll make targeted investments to unlock its full potential.
We expect our investments to support growth in the near term, with the majority of the impact coming in 2026 and beyond. Our second priority is to maximize the pain portfolio. These medicines generate significant durable cash flows and we believe have a longer and more robust revenue stream that remains underappreciated.
That's our priority and frankly when I'm spending a significant portion of my time is to strategically deploy capital to create shareholder value. We are focused on expanding and diversifying our portfolio through business development as we did most recently with the ISO acquisition.
We will continue to opportunistically leverage the share repurchase program and rapidly pay down debt. Our track record of disciplined capital deployment has put us in a position of financial strength relative to our peers, and we will continue to use these levers to create shareholder value. With that, I will now turn it over to Scott to give a commercial update.

Scott Dreyer

Thanks, Vikram, and good afternoon, everyone. I'm excited to share our fourth quarter commercial results with you, highlighting the momentum we created heading into 2025. I'll begin with Jornayey, our lead growth driver.
The ADHD market is large and has been growing at 6% on average from 2019 to 2024. Stimulant medications, methylphenidates and amphetamines make up almost 90% of the market. Within stimulants, 30% of use is methylphenidate products, and the use of methylphenidate is skewed towards the paediatric population with 70% of prescriptions for paediatrics and adolescents and 30% for adults.
Prescribing is highly concentrated with approximately 20,000 HCPs writing 1/3 of prescriptions. The majority of the prescribers are neuro psychiatrists or paediatricians. As HDPs choose a medication for their ADHD patients, they're looking for a medication that provides efficacy upon awakening in the morning and a long lasting duration of effect that can provide symptom control throughout the day.
Jornay has a profile that has the potential to meet that need. Jornay is highly differentiated as the only stimulant ADHD medication with convenient evening dosing. Jornay net provides symptom control upon awakening in the morning and throughout the day, limiting the need for short-acting stimulant add-ons. It has flexible dose dependent duration, enabling treatment to be tailored to the patient's needs.
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 market research, HCPs ranked Jornay as the number one recognized brand, both for achieving all day symptom control with one dose and for controlling evening symptoms after school or work. Jornay is the highest rated brand by targeted healthcare professionals in terms of product favorability.
And when patients and caregivers request to try Jornay, HCPs honor that request. In addition, Jornayey has strong market access coverage. Approximately 65% of the business is commercial and 35% is Medicaid, with Jornay having 80% coverage across the entire book of business. Since we acquired Jornay, we generated momentum and accelerated growth even before making key targeted investments in the brand.
This strong performance speaks to Jornay's potential and supports its position as our lead growth driver. During the fourth quarter, our first full quarter owning Jornay, prescriptions were up 29% year over year and 11% quarter over quarter. For the full year 2024, Jornay prescriptions grew to 636,200, up 31% compared to 2023. In addition, Jornay has a broad and growing prescriber base with 24,300 prescribers in the fourth quarter, up 26% since the fourth quarter of 2023.
And in early 2025 we're encouraged to see this momentum continue despite the typical first quarter dynamics where deductibles reset and out of pocket costs increase for patients. Jornayey achieved an all-time high for weekly prescriptions in the middle of January and it's performing in line with our expectations to start the year. With strong brand fundamentals and clinical differentiation, we see significant opportunity for Jornay, and we're committed to investing in the brand to maximize its growth.
We've identified two main areas to make targeted investments to impact your growth in 2025 and further accelerate growth in 2026 and beyond. The first is increasing awareness and adoption with healthcare professionals. To do this, we're expanding the salesforce to ensure it is optimally sized to reach our target audience. We're expanding the salesforce from approximately 125 to 180 sales representatives. We're making great progress with this work, and we expect to have the expanded Salesforce hired, trained, and calling on HCPs in April.
To complement and am amplify the efforts of the salesforce, we'll also invest in non-personal promotion to increase awareness and the use of Journay among prescribers. The second area of focus is raising awareness of Jornay's unique and differentiated profile among patients and caregivers. Market research shows that patients and caregivers requests are a top influencer of HDP trial, and patients and caregivers have limited knowledge of Jornay and it's differentiated profile.
Therefore, we'll invest in digital marketing and social media strategies and tactics designed to raise awareness among patients and caregivers and to motivate them to ask their healthcare provider about Jornayey. While we expect to benefit from these investments toward the end of 2025, the majority of the impact will be in 2026 and beyond. These investments and their expected impact are included in our 2025 financial guidance.
Turning to our pain portfolio, at Collegium, we take pride in being a leader in responsible pain management with a unique and differentiated portfolio of medicines for the treatment of pain. BELBUCA, Extansa and Lucentia collectively represent over half of the branded market, demonstrating the ongoing strength and reach of our portfolio.
Our commercial organization will continue to capitalize on the momentum we generated for our paint portfolio in 2024. So BELBUCA delivered another strong quarter, with total prescriptions up 5.6% year over year, marking the sixth straight quarter of year over year prescription growth and driving record quarterly revenue.
In addition, we saw acceleration in prescriptions at the end of the year with 6.3% year on year growth in the month of December. We're encouraged by this consistent growth trend which speaks to the impact that our strong commercial execution is having on the brand and BELBUCA's differentiated profile. We expect pressure on prescriptions in the first quarter due to a formulary change that occurred starting on January 1st, as well as the typical first quarter dynamics driven by patient deductible resets. That said, we expect full year prescription growth as well as positive net revenue impact from the formulary change.
Exams to prescriptions grew 2.6% in the fourth quarter compared to the third quarter of 2024, and we saw acceleration of average weekly prescriptions in the month of December. We're encouraged that we were able to generate momentum heading into 2025. We achieved full year gross to net of 52.7%, which reflects the successful execution of our payer strategy and drove record revenue for examsa in the fourth quarter and for the full year.
We expect pressure on prescriptions in the first quarter due to a formulary change that occurred starting on January 1st, as well as the typical 1st quarter dynamics driven by patient deductible resets. We're focused on educating physicians on extansa 's differentiated label and capitalizing on its strong market access position.
Our aspiration is to increase utilization for appropriate patients due to extends to 's superior abuse deterrent properties and labeling.
The Nucenta franchise is a key contributor to our paying portfolio with a robust revenue stream. The positive developments for the franchise, including the new patient population exclusivity extension, six-month paediatric exclusivity extension, and recent Gruenthal settlement with Teva, extended exclusivity of Nina 1.5 years from June of 25 to January of 27, and Ninic two years from June of 25 to July of 27.
This, coupled with the authorized generic agreement with HCMA, enables us to continue to maximize and enhance the durability of the new Sinta franchise in 2025 and beyond. In closing, I'm proud of the commercial accomplishments in 2024, which included integrating and accelerating growth for Jornay delivering strong performance in our pain portfolio and generating momentum for all of our growth drivers in the fourth quarter.
We're now focused on commercial execution, maximizing the potential of the paint portfolio, and accelerating the performance of Jornay in 2025. I'll now hand the call over to Colleen to discuss financial highlights.

Colleen Tupper

Thanks, Scott. Good afternoon, everyone. In 2024, through our dedication to operational excellence, we generated strong financial results and delivered on our 2024 guidance. We grew revenue by 11% and adjusted EBITDA by 9%, generated robust operating cash flows, and strategically deployed capital.
Successful execution of our 2024 financial and strategic priorities established a strong foundation for 2025 financial guidance that reflects significant top and bottom-line growth. As we head into the year, we plan to further strengthen our financial position and create value through disciplined capital deployment.
Financial highlights for the fourth quarter and full year include net product revenues were a record $181.9 million for the fourth quarter, up 22% year over year. 2024 net product revenues were a record $631.4 million, up 11% year over year. Done net revenue was $29.3 million in the fourth quarter, which represents our first full quarter of ownership. Pro forma full year net revenue was $100.7 million, inclusive of $37.2 million recognized by Collegium.
[Euken]in net revenue was a record $55.2 million in the fourth quarter, up 12% year over year, and a record $211.3 million in 2024, up 16% year over year. It stamps the net revenue with a record $51.5 million in the quarter, up 6% year over year. For 2024, [extamps] the net revenue with a record $191.3 million, up 8% year over year.
Full year gross to net was 52.7%, coming in better than our expectation of approximately 55%. The franchise net revenue was $41.8 million in the fourth quarter, down 11% year over year, and $176.5 million in 2024, down 7% year over year. GAAP operating expenses were $60.2 million in the fourth quarter, up 83% year over year. For 2024, GAAP operating expenses were $207.4 million, up 30% year over year.
Non-GAAP adjusted operating expenses were $51.1 million in the quarter, up 97% year over year. For 2024, adjusted operating expenses were $150.6 million, up 22% year over year. As a reminder, adjusted operating expenses increased in 2024 due to the additional operational costs associated with having Jornay in our portfolio.
GAAP net income for the fourth quarter was $12.5 million compared to $31.9 million in the fourth quarter of 2023. For 2024, net income was $69.2 million compared to $48.2 million in 2023. Non-GAAP adjusted EBITDA was a record $107.7 million for the fourth quarter, up 3% year over year, and a record 401.2 million for 2024, up 9% year over year. GAAP earnings per share were $0.39 basic and $0.36 diluted in the fourth quarter compared to GAAP earnings per share of $0.99 basic and $0.82 diluted in the prior year period.
GAAP earnings per share was $2.14 basic and $1.86 diluted in 2024 versus GAAP earnings per share of $1.43 basic and $1.29 diluted in 2023. Non-GAAP adjusted earnings per share was $1.77 in the fourth quarter versus $1.58 in the fourth quarter of 2023.
For 2024, non-GAAP adjusted earnings per share was $6.45 versus $5.47 in the prior year. Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. As of December 30th, first, we had $162.8 million in cash equivalents, and marketable securities. During 2024 $200 million of cash on hand funded our acquisition of Irons or Therapeutics, and we deployed $60 million for share repurchases as part of our share repurchase program.
We reaffirm our 2025 guidance which was issued in January. For the year we expect net product revenues in the range of $735million to $750 million. This growth is forecasted to be primarily driven by Jornay, where we expect net product revenues in excess of $135 million supported by continued durable performance from our paying portfolio.
As is typical within our space, we expect a modest quarter over quarter decline in revenue in the 1st quarter due to typical dynamics where deduct deductibles reset and out of pocket costs increase for patients. We expect adjusted EBITA in the range of $435million to $450 million and adjusted operating expenses in the range of $220million to $230 million.
As Scott previously mentioned, the increase in adjusted operating expenses reflects targeted investments to support Jornay near-term growth and drive significant momentum in 2026 and beyond. With these investments, we are still expecting over 10% adjusted EBITA growth this year, with improvement in the adjusted EBITDA margin beginning in 2026.
This is a testament to our financial strength and the strong financial foundation that our paying business provides. Our spend is expected to be front loaded into the first half of the year as we roll out these commercial initiatives in early 2025.
We remain committed to strategically deploying capital to create value for our shareholders. We plan to invest in Jornay to drive growth, expand our portfolio through business development while opportunistically leveraging our share repurchase program and rapidly paying down our debt.
In 2024, we repurchased $60 million in shares, including $25 million repurchased in the fourth quarter of 2024 and $35 million through an accelerated share repurchase program in May 2024. We have a $90 million remaining in our share repurchase program which is authorized by our board through Q2 of 2025. Finally, we remain focused on paying down our debt. We ended 2024 with net leverage of less than two times and expect to end 2025 with net leverage of less than one time.
I will now turn the call back to Vikram.

Thanks, Colleen. As I mentioned earlier in my remarks, this is an exciting time for our team at Collegium and for the patient communities we serve. The achievement of our financial commitments and the execution of our strategic priorities in 2024 has positioned us for a new phase of growth in 2025 and beyond.
Looking ahead, we are focused on accelerating growth for Journay, maximizing our paying portfolio, and strategically deploying capital to create value. I feel very fortunate to lead a company that is mission focused, financially strong, and well positioned to deliver top and bottom line growth and create value for our shareholders.
Before we open up the call for questions, I wanted to take a moment to thank the entire team at Collegium for their passion and dedication to helping make a difference in the lives of the patients we serve. With that, I will now open the call up for questions, operator.

Question and Answer Session

Operator

Thank you. (Operator Instructions)
First question comes from Leszek Sulewski from Truist Securities. You may proceed with your question, Lesz.

Leszek Sulewski

Good afternoon.
Thank you for taking my questions and, great to have you on the first call, Vikram. Perhaps I'll start there. Could you perhaps lay out any sort of path that you envisioned for collegium over the next three to five years and then perhaps maybe update us on the BD opportunities? Would you say there's a, you're kind of an early, mid or late cycle, of the next deal.
And then, for Colleen, perhaps, could you quantify any synergies that you have been, that you've had realized from the integration of Iron Shore, and then lastly for the team, in regards to no Pain Act, are there any dynamic shift to the pain treatment category that you'd expect, or is this de minimis to your portfolio?
Thank you.

Yeah, maybe I'll kick it up. Thank you for the question. Look, let me first start out by saying that in the last, call it a little over 3.5 months that I've been at Collegium, a lot of what I came in with has been validated. This is a strong team with strong commercial execution. The, with the pain portfolio performing exceptionally well, as well as Jornayey, which is the key part of our portfolio going forward.
These performances lay a very strong financial foundation for us to continue to grow from. As we have said previously, our strategy for long term growth is a function of both organic growth as well as inorganic. Organic growth, as we talked about earlier, we have done it with our main portfolio before and now we're doing it the Jornay.
In terms of business development and inorganic growth, look, our primary focus is on assets that can add meaningful revenue in the near term. In terms of the therapeutic area that we're looking at, there are logical adjacencies to a newly acquired ADHD assets that are our top priority. If you look at ADHD, neuropsychiatry, or even broader CNS, these are areas that we're quite interested in.
Additionally, some of the other areas we're looking at outside of just pure neuro or necropsy, we're interested in areas that are capital efficient, for example, rare or orphan diseases. And then finally, look, we are, we're not against looking beyond into other newer therapeutic areas as well, although as you as you go out further into other areas.
The bar is certainly higher. We would be, we absolutely would look to make sure that they are strategic as well as financial from both strategic and financial perspective that we're able to, it has to make sense for us.
But I'd say let me also maybe end with the fact that given our performance, given where we ended last year at 1.9 times net debt over EBITDA, given the anticipated performance this year where we expect to be less than one time net debt over EBITDA, we're in a pretty strong financial position and so, we're actively looking to expand our portfolio, but at the same time we have to make sure that we will execute both.
Organically with the products we do have as well as look to do the next year, maybe I'll now turn it over to Colleen.

Colleen Tupper

Thanks Les for the question on synergies. Recall, the acquisition of Ironshore in [Jena] as a product specifically was really about taking a flag in a new therapeutic area for us. So we achieved the typical synergies you would expect in that situation on, senior management overlap facilities, GNA type synergies. They were not a meaningful consideration as part of the deal, really for us it was the opportunity to invest strategically behind Jornayey and drive that growth.

Scott Dreyer

And I'll take the No Pay Act last this is Scott. So, on your question on the No Pay Act, yeah, it's had no impact on our portfolio, positively or negatively, and that's because the primary focus of that act is providing additional reimbursement in the inpatient setting. That's where the focus is, and obviously our products are retail-based chronic pain therapy, so no impact on us at this time.

Leszek Sulewski

Great thank you guys and congrats on the.

Progress.
Thank you.

Operator

Thank you. The next question comes from David Anselm from Piper Sandler. Please proceed with your questions, David.

David Amsellem

Yeah, thanks. So, with the Salesforce expansion, sorry if I missed this, but you just remind me what portion of ADHD prescribers or what portion of volumes does the expanded Salesforce encompass, and then secondly related to the sales organization. We've seen ADHD focused sales forces even larger, much larger than even the 180 that you're contemplating.
So, I guess the question is over the long term, how are you thinking about the need for further expansion, and then, I had a question on long term are you thinking about the generic entry of the Luca and Lucenti just given that these are opioids and obviously there's. A lot of baggage associated with generic companies and their role in opioids with all the litigation. So so how are you planning for loss of excessivity for both products looking ahead to 207. Thanks.

Yeah, David, thanks for the question. Look, so maybe I'll kick it off and then I'm going to invite Scott to give some colour on the Salesforce expansion both in terms of what type of coverage universe we have, as well as the size of the Salesforce and then I'm going to call on Colleen to give us some colour on the LOE question related to the paint products. So, look, first of all, we're highly encouraged with our performance to date.
With join AM with the size of the sales force we do have, which was as a reminder 125 sales representatives that came over as part of the Ironshore acquisition and the performance that we just talked about in Q4 has basically been delivered by that team and we're really thrilled with the performance and we're very happy with the progress to date.
As we look into the future, we've also talked about the fact that we're going to expand. The sales force by an additional 55, and that brings the total sales force to about 180. Maybe I'll ask Scott to give some colour on how that changes our coverage universe for HCPs and how that what that means for the business.

Scott Dreyer

Yeah, great. So great questions, David. So, first and foremost, these categories, it's interesting. ADHD, there's some analogy to pain, meaning they're large tails, right? If you look at ADHD prescribing in the United States. There's over 300,000 physicians that write a prescription. That said, 20,000 drive a third of overall prescribing. So, it's a highly efficient way to go to the market. So, when we expand to 180, we will end up covering 60% of the long-acting market, which is what drives the overall market. That puts us at about 23,000 targets, which is exactly where we need to drive forward. You talk about. Future sizing.
Look, every year we will look from a hygiene standpoint at coverage, but what I can tell you is that there's no need, if you look at competitive sets with other sales forces out there, we don't anticipate significant growth, but we'll always look to make sure we're deploying to cover the doctors in an efficient way, and that's what we're focused on.

Colleen Tupper

And then David, I'll take the LOE question and looking across our entire portfolio, there's no party that has the necessary combination of ingredients regulatory clearance, legal clearance, and manufacturing capability to launch competitive generics against any product throughout our portfolio.
Specifically with respect to the new Sinta franchise, there was no party that has the combination of the three necessary ingredients for a near-term competitive generic launch, regulatory approval, clear litigation, contractual hurdles, or access to commercial scale quantities of. All the API and Nina formulations. The LOE dates in our [Ninta] franchise are now due to some extensions we've been able to accomplish.
July 2027 for Ninta and January 2027 for Nuinta IR. The above comments are equally true for Bell Buca and extansa. So, as we proceed into the time frame where there could be generic entrants, what you'll see us do, particularly on Belle Buca in that January 2027 date is invest through that date, and then we will reassess if in fact a player comes in at that point there would only be a single player.

And this is exactly why we've also, we reinforce that we believe we have a longer and more robust revenue stream that remains underappreciated with this business.

David Amsellem

Yeah, that's helpful caller. Thanks, everyone.
Thanks David.

Operator

Thank you. And ladies and gentlemen, just a reminder, if you'd like to ask a question, please press star and then one. If you'd like to ask a question, please press star and then one. We will pause to see if we have any further questions before we conclude.
There are no further questions, which therefore means that we have reached the end of the question and answer session, and I'd now like to turn the call back to Vikram karani for closing remarks.
Thank you, sir.

Great, thank you everyone for joining the call.
Have a wonderful evening and good night.

Operator

Thank you. Ladies and gentlemen, that does conclude the call. You may now disconnect your lines.