...Greetings, and welcome to the Collegium Pharmaceutical Conference Call. At this time, all participants are in a 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 that this conference call is being recorded. I will now turn the call over to Christopher James, Vice President of Investor Relations at Collegium. Thank you. You may begin.
Good morning, and thank you, everyone, for joining us today to discuss Collegium's proposed acquisition of Ironshore Therapeutics, which we announced in a press release issued this morning. I'm 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, risks related to our ability to complete the acquisition on the proposed terms and schedule or at all.
Risks related to our ability to realize the anticipated benefits and synergies of the proposed acquisition. The risk that the business will not be integrated successfully. Risk related to negative effects of this announcement or the consummation of the proposed acquisition on the market price of our common stock and/or operating results. The risks related to future opportunities and plans for Ironshore Therapeutics. 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 press release detailing the announcement and this call will include discussion of certain non-GAAP information. You can find the press release on our corporate website at collegiumpharma.com. I will now turn the call over to our Interim President and CEO, Mike Heffernan.
Thank you, Chris. Good morning, and thank you, everyone, for joining the call today. We are excited to discuss Collegium's proposed acquisition of Ironshore Therapeutics, including its commercial product, Jornay PM, a central nervous system stimulant for the treatment of ADHD in those six years of age and older. Collegium's strategy to build a leading diversified pharmaceutical company is twofold: maximize the potential of our current pain portfolio and strategically deploy capital to create value for our shareholders. Our pain portfolio continues to deliver strong performance, generating an estimated $145 million in net revenue in the second quarter of 2024, up 7% year-over-year. We recently achieved several milestones that improved the outlook of our pain portfolio in 2025 and beyond.
The planned acquisition of Ironshore, when closed, is expected to deliver on each and every one of our strategic objectives related to business development. We will leverage our core competencies with respect to commercial execution and build on our proven track record of efficiently and successfully integrating commercial assets to build our portfolio. We have been laser-focused on identifying differentiated commercial growth assets that diversify our portfolio, have significant revenue growth potential, and have exclusivity into the 2030s. Ironshore meets all of our criteria with Jornay PM. Jornay PM is a differentiated commercial asset that will establish our presence in neurology, specifically the large and growing ADHD market, and diversify our portfolio. Jornay PM has a significant growth potential, which will expand and diversify our revenue base, adding a new leading growth driver to our portfolio.
Jornay PM has been growing rapidly, achieving 58% growth in prescriptions in 2023 and 32% growth in the first half of 2024. 2024 net revenue is expected to be in excess of $100 million, and Jornay PM is supported by 16 Orange Book listed patents with expiries in 2032. Importantly, this acquisition represents a step forward in our strategy to establish a commercial presence in a therapeutic area beyond pain management. By leveraging our strong commercial capabilities and our prior experience in efficiently and successfully integrating commercial acquisitions, we plan to fully maximize Jornay's potential in ADHD. With this acquisition, we are delivering on our commitments to improving the lives of people living with serious medical conditions, creating shareholder value, and building a leading diversified specialty pharmaceutical company.
I'd like to take a moment to congratulate the Ironshore team for building a strong business driven by the success of Jornay PM and fueled by Ironshore's dedication to patients and caregivers in the ADHD community. I'd also like to recognize my Collegium colleagues for their hard work and dedication. Your efforts in support of people and communities we serve, as well as your work in support of this transaction, reflect our commitment to operational execution and have led us to this transformative moment. Collegium has a strong track record of successful business development, which has enabled the growth of our commercial portfolio, delivered durable revenue, and ultimately generated significant and consistent operating cash flows.
The acquisition of Ironshore represents another highly accretive acquisition that will further diversify our portfolio and expand our commercial presence in a large and growing market, and serve as a step forward in building another therapeutic area of expertise.... I will now hand the call over to Scott to further discuss Jornay PM and the opportunity ahead.
Thanks, Mike, and good morning, everybody. Jornay PM is a central nervous system stimulant to treat attention deficit hyperactivity disorder, or ADHD, in people six years of age and older in the United States. Jornay PM is highly differentiated and well-positioned to grow. It's the only stimulant ADHD medication with convenient evening dosing. This is important for pediatric and adolescent patients because it eliminates the need to dose at school or at work. Jornay PM also has flexible dose-dependent duration, enabling treatment to be tailored to the patient's needs. And lastly, it has smooth symptom control throughout the day, limiting the need for short-acting stimulant add-ons. We're thrilled to bring Jornay PM into our portfolio, as it will establish a new commercial presence for Collegium in ADHD. Collegium is the leader in responsible pain management, and we have a proven track record of commercial success with our pain portfolio.
We believe this acquisition presents an attractive opportunity to enter the neurology space by expanding into the large and growing ADHD market and enabling us to build another therapeutic area of expertise. There is significant unmet need in the ADHD market, and Jornay PM is a highly differentiated product that can address that need. The ADHD market has grown 5% on average over the past 4 years, and over the past few years, Jornay PM has delivered significant double-digit prescription growth. In 2023, total prescriptions for Jornay PM grew 58% compared to 2022, to approximately 490,000. Through the first half of 2024, Jornay PM prescriptions have grown 32% year over year. In addition, Jornay PM has a broad and growing prescriber base, approximately 15,000 prescribers per month, and it has strong market access.
The ADHD business is concentrated to the commercial and Medicaid segments, about 60% commercial and 40% Medicaid, and Jornay PM has 80% coverage across these segments. With these strong fundamentals and clinical differentiation, we see significant opportunity for Jornay PM, and we believe it has the potential to be Collegium's leading growth driver, complementing our continued leadership position in responsible pain management. As we've done with our current portfolio of pain products, we plan to maximize the value of Jornay PM and unlock its full growth potential by leveraging our proven commercial capabilities. These include strong market access, commercial operations, and experienced marketing differentiated products in highly competitive markets. We have a proven track record of efficiently and successfully integrating commercial acquisitions, and we'll leverage that experience to maximize the full potential of Jornay PM.
We're excited to build upon the momentum that our colleagues at Ironshore have created for Jornay PM by raising awareness and increasing adoption of this highly differentiated product among healthcare providers, patients, and caregivers in the ADHD community. I'll now hand the call over to Colleen to discuss key financials and next steps for the transaction.
Thanks, Scott. Good morning, everyone. Collegium will acquire all the outstanding shares of Ironshore for $525 million in cash at closing. Collegium will also pay Ironshore shareholders $25 million in additional consideration if Jornay PM net revenue exceeds a defined threshold in 2025. The all-cash consideration will be funded by a combination of Collegium's existing cash on hand and a new $646 million secured financing from Pharmakon. A portion of these funds will also be used to replace our existing term loan with Pharmakon. We secured very favorable terms, which will reduce the interest rate on our current debt of $320.8 million by 300 basis points.
The new term loan has a 5-year term with an interest rate of SOFR plus 450 basis points and will be amortized over 5 years. In addition to lowering our cost of capital, the new term loan has a longer term, a lower required amortization, and more prepayment flexibility. As a result of the transaction, we estimate that our net leverage at year-end will be below 2 times, based on estimated fiscal year 2024 pro forma combined EBITDA. We expect that our significant cash flow generation post-transaction will enable us to delever and maintain a strong balance sheet to fund our growth going forward. The acquisition is expected to close in the third quarter of 2024, subject to customary closing conditions, including receipt of required regulatory approvals.
We expect the transaction to be immediately accretive to Adjusted EBITDA at closing, while being highly accretive to 2025 Adjusted EBITDA. We will generate additional cash flows from operations throughout the next year, and our use of cash will be prioritized to maximizing Jornay PM and strategically deploying capital. We also have $115 million remaining on our authorized share repurchase program. This transaction comes at a time of financial strength for Collegium, and we are excited to close the acquisition and continue Jornay's growth trajectory. I will now turn the call back to Mike.
Thanks, Colleen. Our focus continues to be on creating long-term value through operational execution. Our acquisition of Ironshore aligns with our mission and our strategic objectives. The addition of Jornay PM will diversify our portfolio, establish our presence in a growing market with unmet needs, and represents a step forward in building a new therapeutic area of expertise. This acquisition will also strengthen our financial position by significantly expanding our revenue base, delivering immediate adjusted EBITDA accretion, and accelerating our cash flow generation. We believe this acquisition will create value for our shareholders as we continue to deliver record financial results, generate robust cash flows, and deploy capital in a disciplined manner. We look forward to closing this acquisition and to welcoming the Ironshore team to Collegium. I will now open the call up for questions. Operator?
Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for your questions. Our first questions come from the line of David Amsellem with Piper Sandler. Please proceed with your question.
Hey, thanks. So just have a few questions. First, can you talk about how you're thinking about the commercial organization going forward with the pivot to neuropsychiatry and what that means in terms of headcount, what that means in terms of your existing pain specialist-focused sales organization? Is that organization something you're going to sort of use to reallocate resources and focus on psychiatrists? So maybe help us understand how you're thinking about that going forward. Secondly, I wanted to ask you about exclusivity runway here.
I think you mentioned in the press release that Orange Book patents go to 2032, but I'm just wondering, just are there other barriers here to potential generics that we should be mindful of, such as the nature of the formulation, having delayed and extended release properties, and also just the fact that it's a Schedule II? Just help us better understand how you're thinking about the exclusivity runway with those ideas in mind. And then lastly, what's the mix between ped and adult, in terms of, you know, the usage of the product and how you think that that's going to evolve over time? I know that's a mouthful, but I'll stop there. Thanks.
Thanks, David. I'm going to turn to Scott for the first part of the question on the commercial organization.
Great. Thanks, Mike, and thanks, David. Yeah, great question, David. Look, the key thing I would say, it's not a pivot, it's an expansion. So we will maintain 100% focus on the pain portfolio. That sales team will be fully intact. They will continue to sell those products and drive that almost $600 million business. Separately, we will bring in the full Ironshore sales team, and they will be focused 100% on Jornay PM. So that's how we view these. It's an expansion of Collegium into a new therapeutic area, but both businesses are critically important and will be funded as such. I can also answer the ped-adult mix, since you asked that question.
When it comes to prescriptions, it skews significantly towards pediatrics, north of 80%, and we'll see as we get going what the opportunity is on the adult side.
Great. Thanks, Scott. I'll answer the question for you on exclusivity. As we mentioned, we have this, the product, Jornay PM, has 16 Orange Book listed patents, which expire in 2032. We'll obviously continue to look at other opportunities going forward for expanded exclusivity.
Okay, I'll leave it there. Thank you.
Thanks.
Thank you. Our next questions come from the line of Tim Lugo with William Blair. Please proceed with your questions.
Hi, this is John on for Tim. Congrats on the deal, and thanks so much for taking our questions. So maybe just two from us. First, could you give us some more color on how we should be thinking about how this deal will impact your incremental spend over the next few years? And second, could you maybe give us some color on how you're thinking about prioritizing the deal or versus continuing to repurchase shares? Thanks.
Yeah. So I will turn the call, thanks, John, for the question, to Colleen for the first part of the question.
Thanks, John, for the question. Appreciate that. So what I would say now is we expect this transaction to be immediately accretive and significantly accretive in 2025. We would look forward to providing you more specifics around guidance and what our operating expense levels will be in the normal course, which we do in early January. So we'll update you post-close. On the capital allocation, I would say our top priority is getting this transaction closed and maximizing the potential of Jornay, and then also we will continue to pay down debt and opportunistically return capital via the share repurchase program.
Thank you, Colleen.
Yeah.
Thank you. Our next questions come from the line of Serge Belanger with Needham and Company. Please proceed with your questions.
Hi, good morning. I also want to offer my congrats on the transaction. I guess two questions. First one, can you talk about the sales effort that was behind the product at Ironshore and whether that will change once it transitions over to Collegium? And then secondly, and this is probably for Scott, you talked about 80% coverage. Just wondering if there's any more work to be done on that front. Do you expect additional coverage or even on the prior ops, what that currently looks like and if it can be improved? Thanks.
... Yeah, Scott, why don't you take both those questions if you can? Thank you.
Yeah, no problem. Yeah, so, so first and foremost, right now, the Ironshore team has a field operation that's about 133 representatives. They've done a phenomenal job. When I mentioned the script growth, 58% script growth year-over-year last year, 32% year-to-date this year, right? So we will bring that whole team over, and then we'll always, like we do with our current portfolio, be evaluating the opportunity and if we need more and ensuring that we fully cover the market to reach the full potential. When it comes to the coverage, I think there's a couple key things, Serge. 80% overall coverage, again, that's 60% commercial and 40% Medicaid.
As we do with our pain portfolio, we'll always be looking to get the best coverage we possibly can, and we'll be digging in on that as we get the product. But a couple important things of note as you think about it, compared to our pain portfolio, there's no Medicare Part D business, so some of the kind of baggage that comes with the evolution of Medicare Part D, there's none of that there. That also helps with price in Medicaid because there's not as much discounting to drive coverage for the actual brand. So those are some good things, but we'll be digging in further. But the main point I'd say is, look, it's great coverage right now. It's at a great point, and the team's doing a great job leveraging that to drive growth so far.
Thank you. Our next question has come from the line of Glen Santangelo with Jefferies. Please proceed with your question.
Oh, yeah, thanks. I have a financial question, then a high-level one. So, Colleen, maybe let me start with you. I know you kind of gave us this in the prepared remarks a little bit, but could you give us a little bit more in terms of how much cash you plan to use off the balance sheet and how much, you know, you're wrapping into this term loan and what the rate is on that? Specifically, what is the rate on that term loan? Because I'm trying to just reconcile all these comments with the view that you think it's gonna be immediately accretive to EBITDA. So any sort of those pieces would be helpful, and then I have a follow-up question.
Thanks for the question, Glen. So the term loan of $646 million is, takes out or replaces our existing term loan with a remaining balance of about $321 million. So as you think about the totality of the new term, it's about half to use for this acquisition and half to replace our existing note. The interest rate, which we're very pleased with, is SOFR plus 450. And as we think about accretion, we're expecting immediate accretion on an adjusted EBITDA basis, significant cost of capital savings with that 300 basis point reduction to our existing interest rate.
Okay, perfect. That's helpful. Hey, Mike, maybe if I could just follow up with you. I mean, the obvious question is, right, that you're doing this deal, you know, only a couple months after a sort of sudden CEO departure. And so, you know, it makes us wonder if you're playing devil's advocate for a second, you know, what are the biggest risks you see related to the transaction? I mean, when you look at sort of the revenue runway, you know, question came in about the competitive landscape, you know, how does a safety or efficacy related, like sort of, you know, what are some of the concerns you had to consider when looking at this transaction? Thanks.
Yeah, I mean, I think that the strategy, the business development strategy has been pretty straightforward and well articulated over time. And interesting enough, we've continued to look at assets that fit a very specific criteria. And that criteria was really commercial-based assets that were highly differentiated, had significant revenue and growth potential, had durable revenue with exclusivity into the 2030s, and really allowed us to leverage our commercial core competencies as well as our experience in integrating commercial assets. This fits squarely in that, it opportunistically came our way, and it was the right deal at the right time for Collegium.
Have you been looking at it for a while, or, or is this something that just suddenly came up?
We've been looking at this as we look at all assets over time. We have been aware of this, but we actively got involved in the process recently.
Okay, thank you.
Thank you. Our next question has come from the line of Les Sulewski with Truist Securities. Please proceed with your questions.
Good morning. Congrats on the transaction, guys. Just quickly on the drug delivery system, is this unique to Ironshore? Can this platform be repurposed? And are you aware of any other nighttime treatments for ADHD in development now? And I have a follow-up.
Scott, you want to take that?
Yeah. So, good question. In terms of use of the technology in other places, I'm not going to comment on that one. Right now, the focus is Jornay, but it is unique, right? It is the only product that is dosed in the evening for ADHD. The key is what that leads to, like, why is that evening dosing important? And that's because it eliminates the need to dose at school or work or throughout the day. It provides a smooth... The technology allows for kind of a smooth onset upon awakening and then control throughout the day. And it has five doses. So those five doses allow for flexibility by the physician when treating the patient to kind of manage the onset and the duration of effect. So that all is unique to this asset, and is what excites us about it.
There's nothing, meaningfully on the horizon, in the competitive set for years to come.
Got it. Thank you. Can you just comment, if at all, what is the margin profile versus your current portfolio? And then, any royalties owed to or owed by Ironshore? Thank you.
... Colleen, do you want to take that?
Yeah, absolutely. So I'll just give you a general answer. So from a margin profile perspective, high-margin product, we will provide more information post-close, and when we provide you with 2025 guidance. And yes, there is single-digit royalty associated with the asset.
Thank you. Our next question has come from the line of Oren Livnat with H.C . Wainwright. Please proceed with your questions.
Thanks. I have a couple. Just to build on your high-level comments about, you know, maximizing the value of Jornay, you know, can you just talk about what capabilities or resources you bring to the table that maybe were not available yet at Ironshore? And, are you comfortable talking about the peak potential or the bookends on peak potential for this product? You know, I know when you talked about your BD strategy, you always talked about, a hundred and fifty million revenue potential, I think, for example, with the products you're looking at. I follow, so.
Yeah. Thank you, Oren, for the question. Scott, you want to take that first one?
Yeah, great. Yeah, thanks, Oren. In terms of building on the capabilities, I think first and foremost, it's our established capabilities, relationships, and market access relationships, and what we've proven from an overall commercial capabilities applied to pain. I think the other thing that we bring to the table is due to the strength of our pain business and the significant cash generation, we are absolutely able to fully invest to maximize Jornay, and that's what we're going to be focused on doing. Colleen, do you want to speak to-
Yeah, Oren, I won't, I won't provide anything on peak sales at this point in time. What I would say is really there is a strong revenue base. We expect full year 2024 sales to be in excess of $100 million. Scott spoke specifically about the really robust year-over-year prescription growth in 2023 and the first half of 2024, and we'll look forward to providing you an update on guidance in the coming months, post-close.
Okay. And I think maybe David touched on this upfront about any changes to the existing business. I think you said steady as she goes on that front. But can you just talk about now that, you know, the growth, this is a higher growth market and with a longer, at least a longer certain runway that we can look at for this franchise versus the pain or at least the, some of the pain business. So will you be ... I guess, when we think about the priorities and where the investment is in this business going forward, are you going to be more focused on this new neuropsych unit?
And perhaps when you think about business development, more on that front and, I guess, leveraging that business, and will you, I guess, spend less, I guess, be more explicit on the pain side? And I have one last question after that.
Yeah, I'll take that one. This, the pain business is a very important business to Collegium. It's a major cash generator, it's a growth business, it's a stable business, it's a durable business, and that will remain as important and high priority as it always has been. The new opportunity really allows us the growth opportunity to be a significant growth driver that maybe we didn't necessarily have in our pain business at this peak point in time. And we will look to build out a therapeutic expertise in the new category, neuropsychiatry, similar to the way we've built expertise in the pain market. So that is the goal going forward, and this really provides us the opportunity as a beachhead for that.
All right. And just lastly, also, you talked about IP to 2032 and, I guess, no specific comment on the formulation, science, and whether there's other barriers, but, I guess explicitly, are there already any generic filers, P4 or otherwise, on this product?
Yeah, there are, there are no current P4 filers at this time.
All right. Thanks so much. I look forward to following up after.
Thank you. This does conclude the question and answer session. I would now like to hand the call back over to Michael Heffernan for any closing remarks.
Thank you, everyone, for joining the call today. We look forward to providing more wholesome company updates on our upcoming earnings call on August eighth. Have a great week.
Thank you. That does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.