Greetings, and welcome to the Collegium Pharmaceutical Third Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note that this conference call is being recorded.

I will now turn the call over to Danielle Jesse, Director of Investor Relations at Collegium. Please go ahead..

Welcome to Collegium Pharmaceuticals third quarter 2024 earnings conference call. I am joined today by Mike Heffernan, our Interim President and Chief Executive Officer, Founder and Chairman; 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 provision 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 incur significant expense in doing so, though we may not prevail in current or future litigation pertaining to our business.

Risks related to our ability to realize the anticipated benefits and synergies of the recently completed acquisition of Ironshore. The risk that the businesses will not be integrated successfully and risks related to future opportunities and plans for Ironshore.

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 collegiumpharma.com. I will now turn the call over to our Chairman, Interim President and CEO, Mike Heffernan..

since the acquisition closed in September, we've seen accelerated growth in Jornay PM prescriptions during the back-to-school season. Through the first three quarters of 2024, Jornay prescriptions are up 31.2% year-over-year.

We delivered another strong quarter for Belbuca, marked by record revenue of $53.2 million, up 17% year-over-year and strong prescription growth of 3.5% year-over-year and 2.6% quarter-over-quarter. We generated record Xtampza ER revenue of $49.5 million, up 24% year-over-year.

We achieved new payer wins for Belbuca and Xtampza ER, which are expected to support revenue growth in 2025. We continued our history of leadership at PAINWeek through the presentation of eight posters highlighting the clinical and population health impact of our differentiated PAIN portfolio.

and we established our presence at key ADHD congresses, including a presentation on Jornay PM at the American Academy of Child and Adolescent Psychiatry 2024 Annual Meeting in the Canadian ADHD Resource Alliance 2024 Conference. I will now turn it over to Scott to give a commercial update..

achieve broad coverage for our products, while delivering on our commitment to enhance profitability of our brands by managing gross to nets. We're pleased to share that Belbuca and Xtampza ER were both added to formulary for a large integrated health system that represents approximately 8 million commercial lives and 2 million Part D lives.

We expect revenue growth from this expansion of coverage. However, because this system purchases directly and does not report prescriptions, we won't see the corresponding prescription volume in IQVIA data.

In addition and consistent with our focus on enhanced profitability, one Medicare Part D plan representing 8 million covered lives, we'll be removing with Xtampza ER and Belbuca from formulary effective January 1. Xtampza ER will be a parity with OxyContin within this plan as both products are off formulary.

As a result of this change, we will pay zero rebates for Belbuca and Xtampza within this plan. These formulary removals will pressure prescriptions for both Xtampza and Belbuca in 2025, but are expected to be net revenue positive for both brands as the prescription decline offset by profitability improvement.

In closing, I want to thank the commercial team at Collegium for the strong execution and performance they've delivered for both our PAIN and ADHD businesses. As we finish the year, we're focused on driving momentum in our PAIN portfolio and maximizing the potential of Jornay PM.

We believe we're well positioned for meaningful growth in 2025 and beyond. I'll now hand the call over to Colleen for a discussion of the financials..

Thanks, Scott. Good afternoon, everyone. Our third quarter performance reflects strong revenue growth impactful business development, significant bottom line expansion and robust operating cash flows. Financial highlights for the third quarter include total net product revenues were a record $159.3 million in the third quarter, up 17% year-over-year.

In line with our expectations for the third quarter, Jornay revenues were $8 million, which reflects less than one month of commercial sales and the effect of legacy ordering patterns during the ownership transition. The PAIN portfolio delivered strong performance with record revenue of $151.3 million, up 11% year-over-year.

Belbuca net revenue was a record $53.2 million, up 17% year-over-year. Xtampza ER net revenue was a record $49.5 million, up 24% year-over-year and Xtampza ER gross to net was 50.8% in the third quarter. The third quarter did benefit from a one-time favorable managed care rebate adjustment resulting from a formulary review.

With this benefit factored in, we now expect full-year Xtampza ER gross to net to be approximately 55% in 2024, which is the low end of the range we previously communicated. Nucynta franchise net revenue was $45.1 million, down 5% year-over-year. GAAP operating expenses were $62 million, up 76% year-over-year.

This quarter included $19.9 million in acquisition-related expenses associated with the Ironshore acquisition. Adjusted operating expenses, which excludes stock-based compensation and acquisition-related expenses were $34.8 million, up 23% year-over-year. GAAP net income for the third quarter was $9.3 million, down 55% year-over-year.

Non-GAAP adjusted EBITDA was a record $105.1 million, up 18% year-over-year. GAAP earnings per share was $0.29 basic and $0.27 diluted in the third quarter, compared to GAAP earnings per share of $0.61 basic and $0.53 diluted in the prior year period. Non-GAAP adjusted earnings per share was $1.61 in the third quarter, up 20% year-over-year.

Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. As of September 30, 2024, we had $120 million in cash, cash equivalents and marketable securities.

We generated another quarter of strong operating cash flows, enabling us to execute our capital deployment strategy and complete the acquisition of Ironshore, which utilized approximately $200 million of cash on hand. We are reaffirming our 2024 financial guidance, which we updated following the close of the Ironshore acquisition.

We expect net product revenues in the range of $620 million to $635 million, Belbuca revenue growth is primarily fueled by full-year prescription growth, while revenue growth for Xtampza ER is driven by gross to net improvement. 2024 full-year pro forma Jornay PM net revenue is expected to be in excess of $100 million.

For the Nucynta franchise on a full-year basis due to the elimination of the Medicaid cap by the American Recovery Act, we expect some pressure on the Nucynta franchise year-over-year revenues in 2024 with a return to relative year-over-year stability in 2025.

We expect adjusting operating expenses in the range of $150 million to $155 million and adjusted EBITDA in the range of $395 million to $405 million. With our strong financial performance thus far, we are well positioned to deliver on our financial commitments for 2024.

We remain focused on our capital deployment strategy to create long-term value for our shareholders by executing on business development through the integration of Jornay PM, paying down debt and opportunistically repurchasing shares.

We have a proven track record of successful business development, including the acquisition of the Nucynta franchise and Belbuca, and we will leverage this expertise to efficiently integrate and maximize the potential of Jornay PM.

We are already seeing immediate accretion with the addition of Jornay PM and expect the product to be accretive to adjusted EBITDA in 2025. We're committed to investing in the continued growth of Jornay PM as we look to build a new therapeutic area of focus beyond pain. We are also focused on managing our debt.

With the Ironshore acquisition, we secured a $646 million new term loan from Pharmakon. $320.8 million of the new term loan was used to replace our prior loan with Pharmakon reducing our interest rate on this balance by 300 basis points.

In addition to the significant improvement in our cost of capital, the new loan also has a longer-term lower amortization and more prepayment flexibility. We estimate that our net leverage at year-end will be less than 2 times net EBITDA based -- sorry, less than 2 times based on estimated fiscal year 2024 combined EBITDA.

In addition, we have $115 million remaining in the $150 million share repurchase program approved by our Board earlier this year. We are confident in the strength of our business and the value it will continue to generate and will opportunistically leverage share repurchases to return value to shareholders.

Looking forward to 2025 and beyond, we will continue to leverage the momentum and financial strength of our core PAIN business to deliver on our financial commitments of growing revenue, increasing profitability and generating robust cash flows.

The outlook of our PAIN business is bolstered by the recent positive developments for our PAIN portfolio, the Nucynta franchise authorized generic agreement with Hikma and the pediatric exclusivity extension, along with our successful payer strategy and tailwinds from the Medicare Part D redesign, are expected to drive organic growth in 2025.

At the same time, we are focused on integrating and maximizing the value of Jornay PM and investing in its future growth. Jornay PM is poised to be our lead growth driver as we build on the positive momentum, we are already seeing just a month into owning the product.

We remain dedicated to the disciplined execution of our capital deployment strategy as we look to expand our portfolio of commercial products, pay down debt and opportunistically return value to shareholders through share repurchases. I will now turn the call back to Mike..

Thanks, Colleen. We are proud of our accomplishments in the third quarter, which positioned us for continued success in 2025. For the remainder of the year, we are focused on integrating and maximizing Jornay PM in addition to delivering on the financial and strategic commitments of the core PAIN business.

We are confident in our ability to deliver record financial results, generate robust cash flows and deploy capital in a disciplined manner.

I'd like to personally thank the Collegium leadership team for their exceptional stewardship through the transformational Ironshore acquisition, and we're very excited to welcome Vikram as our new CEO this month to join our strong team.

With his extensive commercial and business development experience, I am confident he is the right person to lead Collegium through this next phase of growth. I will now open the call up for questions.

Operator?.

Thank you. [Operator Instructions] And our first question comes from the line of Les Sulewski with Truist Securities. Please proceed..

Good evening. Thank you for taking my questions. I have a few, maybe first for Mike or Colleen. Congrats on the impressive CEO selection.

And although it might be premature, but given Vikram's strong rare disease background, would you expect any divergence in BD plans into new therapeutic areas? Or do you essentially expect to continue to anchor around the new neuro category? And then maybe for Scott, what are the plans for Belbuca and your investment efforts leading into LOE? And then what is the value proposition of Belbuca against some of the other chronic pain products, specifically those undergoing clinical trials such as [Indiscernible]? And then maybe last, can you talk about the back-to-school season with Jornay, how much of that script growth was tied to the ownership change? And what do you, I guess, envision the peak sales potential or peak market share potential from Jornay across the ADHD market.

And then in general, can you highlight how impactful is the back-to-school season seasonality to this product? Sorry for the mouthful, but thank you..

Thank you, Les for the question. This is Mike. I'll start at the beginning, and then I'll ask Scott to jump in on some of the other questions. As it relates to our strategy, since we closed the Ironshore acquisition in early September.

And as I mentioned in the -- for the balance of the year, we're really focused on integrating Jornay and growing Jornay, as well as maximizing our PAIN portfolio. So that is a key part of our strategy. We'll also continue our business development efforts to identify assets that allow us to build our expertise in a new therapeutic area beyond pain.

As Vikram gets further acquainted with the business, he’ll work with both our leadership team as well as the Board to further build out Collegium's strategy and execution and further put a fine point on the business development strategy. I'll pass it to Scott for the question of Belbuca LOE..

Got it. All right, Les. So starting with Belbuca LOE, look, the biggest thing I'd say there is we are investing through the tape. So right, we're not -- we don't view Belbuca as an asset where we're in harvest mode. The fact of the matter is -- you look at the current LOE assumptions, we think there may be some upside there.

So we're investing fully in the product. To your question about competition and the Vertex product, first, I'd just say any new product in PAIN, we're a fan of as the leader of responsible PAIN management, we believe in options come to the market that are helpful for patients.

That said, that product has no competition in the chronic pain place where all of our products play not just Belbuca.

So don't view it in any way competitive and think Belbuca has a runway -- a long runway of growth as the use of buprenorphine in pain continues to increase, the buprenorphine market is growing and Belbuca is highly differentiated within the market.

On back-to-school, which you asked about Jornay, look, we're really happy with what's happened during the back-to-school season. So we closed the deal kind of in the middle of the season, the season kicks in, in the August time period. And the team has done a tremendous job focusing on execution.

We've seen -- if you look at the average weeklies, we've seen 18% growth comparing October versus July. We expect that momentum to continue as the seasons typically has an impact that carries into November and think it's just going to set us on a great trajectory as we enter 2025.

You asked about peak sales, and we don't give peak sales guidance, so we're not going to give any more color on that. I'll just reinforce the growth trajectory of Jornay is very strong, and we expect that to continue as we go into next year..

Excellent. Thank you for that color..

And the next question comes from the line of David Amsellem with Piper Sandler. Please proceed..

Thanks. So on Jornay PM, can you remind us how you're thinking about the gross to net spread going forward whether you can give us a range or just give us some sense of what the gross to net looks like in relation to other branded agents for ADHD. That would be helpful. That's number one.

And then number two, just coming back to business development and M&A. So with Jornay, you've got sort of an interesting and somewhat diverse call audience. I believe there's pediatricians, general practitioners, psychiatrists who are prescribing the product.

So given that call audience and the commercial infrastructure you have, how does that inform how you're thinking about future business development M&A? Thanks..

Great. Thanks, David.

Scott, do you want to take the first question on Jornay PM in gross to net?.

Yes, yes. Sure. So Colleen and I will tag team on this one. First, I'll just start with coverage and reinforce that when you look at coverage for the brand, it's very strong right now 60% of the businesses is in commercial, 40% is in Medicaid, and Jornay has coverage across 80% of that overall. So what that means is we're happy with the coverage.

We will always look to expand coverage. But as we've done on the PAIN side, we'll be disciplined in terms of choices we make to expand that coverage. Collen, you want to give a little more color on gross to net..

Yes. I'd say, David, we look forward in early January to give you a bit more color on guidance. But what we're seeing for gross to net on Jornay is typical what you'd see in branded ADHD products. It's sitting in the 60s range. You have, obviously, rebates making up a big portion of that and also the co-pay program, which is typical in this space..

And then the other question on BD, as you know, our focus has really been moving beyond pain. And as you suggested, Jornay PM and our call points give us a lot of flexibility to go in a number of different directions. I mean, clearly, we'd like to leverage our new commercial expertise and overlap.

And again, because of the call points, I think we -- it gives us a lot of optionality. We'll primarily spend our time integrating Jornay and thinking about a lot about how to grow it.

And then as Vikram comes in and we analyze the opportunities that are in front of us, we will, as we move into next year, I'm sure move our development strategy forward such that we will be looking to really leverage and new expertise beyond pain..

Yes, that's helpful. Thank you..

And the next question comes from the line of Serge Belanger with Needham & Company. Please proceed..

Hi, good afternoon. A couple of questions for us. I guess the first one regarding the integration of Jornay PM. Scott, I think you talked about sales force sizing for that products.

Just curious what the current size of the sales force is and how you're thinking about the modifications to that? And then secondly, regarding the changes to formulary coverage on both Xtampza and Belbuca. I think there were two pieces. So first, on the -- where you're losing exclusivity. Just curious how many prescriptions are at riskier.

And on the new plant, is there an existing Oxy business that's allows you -- that provides a conversion opportunity for that new -- any formulary? Yes, that’s it. Thanks..

Great. Thanks Serge. Scott, it sounds like these are both for you on the integration..

Sounds good. Yes. So Serge, first, when it comes to the sales force and our current situation. So currently, we have about 150 salespeople all in. That's reps and management. And we're doing the work right now to assess where we go from here. We believe that we need to expand a bit to get the coverage we want.

And look, our focal point is around maximizing the potential and raising awareness. And that means we're looking at where prescribing happens and ensuring that we have enough coverage to get the recent frequency that's needed to continue to accelerate the growth of the brand.

And so when we get January and our OpEx guidance, that will all include any final choices we make on the sales force. To your second question about the formulary changes, so we'll take them one by one. In terms of the addition, 8 million lives in commercial, 2 million lives in Part D at the integrated health system that I mentioned.

Right now, there's a little bit of OxyContin business in there, but not much. So it's a little bit different than the conversion opportunities we've had in the past and more of a starting with fresh coverage when it comes to OxyContin. When it comes to Belbuca, there is some use but a lot of opportunity in front of us in the plan.

In terms of scripts, you said where we were removed from formulary at the Part D plan that I mentioned with 8 million lives, so that's in that plan. It's about 12% of Belbuca prescriptions. It's about 18% of Xtampza prescriptions that sit within that plan.

And as a reminder, it's an opportunity where we were not willing to pay what it would take to keep that access and the rebate will go to zero. And so we are confident that it will be net revenue positive overall, while seeing the pressure on prescriptions in those plants. Hopefully, that helps Serge..

Yes.

So when you combine the two changes with the new addition and the change to the existing formulary, do you think it will be a wash in terms of decision volume for both Xtampza and Belbuca?.

Yes. So it's a wash in terms of lives not in terms of prescriptions, because as I mentioned, to the integrated health system, they don't have prescriptions reported through IQVIA. So we'll have revenue that comes through, but you will see no prescriptions whereas where the removals happen, that is directly IQVIA impacted scripts.

So that will, again, all be factored in when we give our revenue guidance in January, as we always do, all those ins and outs will be there. But what's important is revenue will be different in terms of scripts in those two different situations, if that makes sense..

Yes. Thanks for the call..

Yes..

And the next question comes from the line of Oren Livnat with H.C. Wainright. Please proceed..

Thanks, I have a couple. Just to follow-up on the questions regarding Victor's appointment as CEO. Can you just talk about what made him a good fit given his experience in global rare disease versus your portfolio of mass market. ADHD and PAIN products.

Should we take it to -- should I assume that your existing core management competencies on that front will maybe be elevated, and he will be more focused on broadening your horizons into other areas? Or is he excited and prepared to take on maybe a different sort of book of business? And I have a follow-up, all. So thanks..

Thank you, Oren. Yes, let me talk a little bit about Vikram's experience. As I mentioned, he's been in the biopharma for over 15-years. But he was involved in every aspect of the Horizon business as the business grew from $300 million in revenue to $4 billion and as we know, resulted in a $28 billion acquisition by Amgen.

He successfully led the transformation of the company it's commercial growth, the building of its international division. And those skills regardless of therapeutic expertise are certainly transferable when it comes to leveraging the growth of Collegium in the next phase of growth.

I think Vikram is and he'll talk to you about this because he's starting you started next week, but I think he's pretty excited about the base business that we've created at Collegium. It gives them a great substrate to build upon with a very strong business and a very strong management team.

And so for any new CEO coming into a situation, he's got really the opportunity to already have a growth business and then take his expertise, which is in addition to the expertise we already have and build on the growth. So we're really excited about having to join the company..

Got it. And on Jornay PM, you highlighted the pretty strong execution through back-to-school, but I can't imagine there wasn't some friction or disruption with the corporate change and yet it looks like you're delivering. Look, I think about 25% year-over-year growth right now.

Is it fair to say that you're not firing necessarily on all cylinders during the transition, maybe growth could actually inflect upwards again, even on a year-over-year basis with both settling of the organization, rightsizing and some increased resource allocation?.

Yes. Thanks, Aaron.

Scott, do you want to take that?.

Yes, that's great. Yes. Oren, great question. So first, I'd say really, we didn't see disruption, and that was purposeful, because as you may recall, we kept the entire sales force management team and everybody intact to ensure continuity.

So to the first question, yes, firing on all cylinders, year-over-year growth is actually up 31.2% and that accelerated during back-to-school season, frankly, at a greater rate than they accelerated last year during back-to-school season. So the team needs a tremendous amount of credit for that continuity during that time.

Now to your question going forward, of course, there's future opportunity. And I put it into a couple of buckets. First, food execution, right? We will bring our expertise to ensure that we're executing on all cylinders in front of the customer. That's number one.

Number two, as I mentioned in my prepared remarks, we'll ensure that we're adequately sized and investing from a marketing standpoint to drive awareness and uptake among HCPs first.

And then number three, if you think about the profile I laid out of this product, clearly, it's a product that if you're a caregiver and understand that there's a product for ADHD that you could dose once in the evening and that could carry you through your trial through the next day from upon awakening all the way through the day.

That's a pretty interesting product for caregivers and for patients, and the awareness there is very low. So we will take action and make investments to take advantage of that opportunity. So those are the things we'll be focused on as we move through 2025 to continue the growth momentum of the brand..

All right. And on Jornay in the market, it's obviously a highly genericized overall ADHD space. I know if not I'm mistaken, there's only a couple real unique branded methylphenidate products out there, and you've got [Asteris] (ph) with a prodrug and you guys with this pretty unique dosing.

Can you talk about your field reception out there with regards to other branded competition and your differentiation and maybe how it seems to be shaking out in terms of patient or physician preference for these two different value propositions?.

Yes.

Scott, do you want to take that?.

Yes. Yes. So a couple of insights I'd give you. One, if you just look at performance in the market, the growth of Jornay in the back to school season has exceeded competitive sets. So that's number one. And that includes also Calbee as the non-stimulus. So when you look at just the branded marketplace, the reception is really strong and growing.

When you look at physician feedback, what we're hearing is that they truly see the uniqueness not just of the evening dosing, but the fact that the product carries through the next day from morning through the day.

So they look at, for instance, in Asteris, as more of another kind of typical type of extended release product, like a lot of the extended release products that have gone generic. But they see Jornay as being truly different.

And the best evidence we have of this is when someone switches to Jornay in the early data we're seeing, it's a stickier product. and actually adherence is a little bit longer on it than other ADHD medications. So that's what we're seeing in the marketplace. The reception is good.

The prescriber base, as I shared, is growing up 25% year-over-year, almost 23,000 physicians in the third quarter. So there's a good receptivity, there's a momentum behind the drug, and we're going to continue to try to continue to keep that going..

And just lastly, one housekeeping thing.

I haven't run the math yet with gross to net and the low Xtampza ER numbers, so maybe that's lines up perfectly, but were there any material inventory moves on Xtampza or any other product up or down in the quarter?.

Sorry. Yes, I jumped in too quick. Oren, across the PAIN portfolio, it's pretty consistently around 15, plus or minus a half. On Jornay because it was a little bit less than a month that we had ownership and they had for one of the big three wholesalers, every other week ordering pattern. We have lower days on hand than you typically see.

So Jornay ended September, just shy of 11 days on hand, and you would normally expect that to be about 15, but that was the only difference, I'd call..

All right. Thanks so much..

Thank you..

Thank you. Ladies and gentlemen, this concludes the question-and-answer session. I'll turn the call back to Mike Heffernan for his closing remarks..

Thank you, everyone, for joining the call today. Have a great evening..

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