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Earnings call: Collegium Pharmaceuticals reports strong Q3 growth

Published 2024-11-08, 03:20 p/m
COLL
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Collegium Pharmaceuticals, Inc. (NASDAQ: COLL) demonstrated robust financial growth in its Third Quarter 2024 Earnings Conference Call, with a 17% increase in total revenue and an 18% rise in adjusted EBITDA year-over-year.

The successful integration of Ironshore Therapeutics and its ADHD treatment, Jornay PM, is expected to significantly contribute to the company's net revenue, projected to surpass $100 million in 2024. The pain management portfolio, including Belbuca and Xtampza ER, also showed strong performance.

Key Takeaways

  • Collegium Pharmaceuticals reported a 17% increase in total revenue year-over-year in Q3 2024.
  • Jornay PM prescriptions rose by 31.2% due to demand during the back-to-school season.
  • Belbuca and Xtampza ER achieved record revenues, contributing to the pain portfolio's success.
  • New CEO Vikram Karnani is expected to capitalize on his experience to further Collegium's growth.
  • The company provided positive financial guidance for 2024, with projected net product revenues of $620 million to $635 million.

Company Outlook

  • Collegium anticipates revenue growth in 2024, driven by improved gross-to-net ratios and the full integration of Jornay PM.
  • The company plans to manage debt effectively and execute share repurchases to enhance shareholder value.
  • Strategic investments in Belbuca and expansion of the sales force for Jornay are planned to maximize market coverage.

Bearish Highlights

  • Some formulary removals may pressure prescriptions in 2025.
  • Exclusivity loss impacts a portion of Belbuca and Xtampza scripts.

Bullish Highlights

  • Xtampza ER achieved a record 38.1% market share in its segment.
  • Collegium is committed to educating physicians and expanding market access for its products.
  • The Nucynta franchise is expected to contribute positively through strategic agreements.

Misses

  • The company experienced lower inventory levels for Jornay PM than typical due to recent ownership transitions.

Q&A Highlights

  • Discussion of Vikram Karnani's appointment as CEO focused on his track record of growth and expansion in the biopharma industry.
  • Jornay PM's strong performance and unique evening dosing attribute were emphasized as key factors in its market success.
  • Collegium's strategy to raise awareness among caregivers and patients is aimed at maintaining brand growth into 2025.

Collegium Pharmaceuticals remains focused on leveraging its recent acquisition and strong product portfolio to ensure continued financial growth and market expansion. The appointment of a new CEO with a proven growth track record bodes well for the company's strategic direction and integration efforts. Despite some challenges, Collegium's positive outlook and strategic initiatives indicate a commitment to strengthening its position in the ADHD and pain management markets.

InvestingPro Insights

Collegium Pharmaceuticals' strong financial performance in Q3 2024 is further supported by data from InvestingPro. The company's revenue growth of 9.62% over the last twelve months aligns with the reported 17% increase in total revenue for the quarter. This growth trajectory is expected to continue, as one InvestingPro Tip suggests that net income is projected to grow this year.

The company's impressive gross profit margin of 88.97% for the last twelve months underscores its operational efficiency, particularly in its pain management portfolio. This is highlighted by an InvestingPro Tip noting Collegium's "impressive gross profit margins." Such strong margins contribute to the company's ability to invest in strategic initiatives like expanding the sales force for Jornay PM and educating physicians about their products.

Collegium's market performance has been noteworthy, with a one-year price total return of 50.19% as of the latest data. This aligns with the InvestingPro Tip indicating a "high return over the last year," reflecting investor confidence in the company's growth strategy and recent acquisitions.

For investors seeking a deeper understanding of Collegium Pharmaceuticals' financial health and market position, InvestingPro offers additional insights. The platform provides 9 more tips for COLL, which could offer valuable perspectives on the company's valuation, management strategies, and future prospects.

Full transcript - Collegium Pharmaceutical (NASDAQ:COLL) Q3 2024:

Operator: Greetings, and welcome to the Collegium Pharmaceutical (TADAWUL:2070) 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.

Danielle Jesse: 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.

Michael Heffernan: Thank you, Danielle. Good afternoon, and thank you, everyone, for joining the call. Today, we will discuss Collegium's record financial performance during the third quarter and provide an update on our business, including the very exciting news that we have successfully completed our CEO search. At Collegium, we're focused on building a leading diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. This quarter, we completed the acquisition of Ironshore Therapeutics and its commercial product Jornay PM, and we're excited to welcome the employees of Ironshore to our team as we embark on our journey of improving the lives of patients in the ADHD community. We strive to do good as we do well and I'd like to recognize the Collegium team for their commitment to our mission and continued dedication to making a positive impact on the communities we serve by driving equitable access to STEM education and advancing the next generation of life science leaders. Our third quarter and year-to-date results reflect Collegium's strong operational execution. We are on track to deliver on our 2024 financial commitments as updated following the closing of our acquisition of Ironshore. We've made significant progress in successfully integrating Ironshore, and we continue to generate robust operating cash flows to drive significant top and bottom line growth, including growing total revenue 17%, and with 11% growth in our pain portfolio revenue and adjusted EBITDA growth of 18% on a year-over-year basis in the third quarter. The financial strength of our pain business enabled our acquisition of Ironshore and its commercial product Jornay PM. The central nervous system stimulant for the treatment of attention proactivity disorder, or ADHD, and people six years of age and older. Jornay PM is highly differentiated commercial asset that diversifies our product portfolio beyond pain and has significant revenue and growth potential and exclusivity into the 2030s. Jornay PM is expected to generate net revenue in excess of $100 million in 2024, expands our commercial presence into ADHD, a large and growing market and is poised to become the leading growth driver for Collegium. Since closing the Ironshore acquisition in early September and for the balance of the year, we are focused on integrating the Ironshore business, while maximizing the pain portfolio and developing the path to maximize growth of Jornay. We will also continue our business development efforts to identify assets that allow us to build our expertise in a new therapeutic area beyond pain. As we look to close out a strong year, we are confident that we will deliver on our financial commitments and strategic objectives, enabling strong top and bottom line growth in 2025 and beyond. After an extensive search process, we are very excited to welcome Vikram Karnani as our new CEO, Chief Executive Officer and member of our Board, effective on November 12. The Board of Collegium is convinced he is the right leader with the right skills and the expertise and experience to lead Collegium to its next phase of growth. Vikram is a proven leader with more than 15-years of experience in the biopharm industry, including holding various leadership positions across commercial, medical affairs and business development. Most recently, after the acquisition of Horizon by Amgen (NASDAQ:AMGN), he led Amgen's Rare Disease business as Executive Vice President, and President of Global Commercial Operations and Medical (TASE:PMCN) Affairs. Prior to that, he held numerous leadership positions at Horizon Therapeutics (NASDAQ:HZNP) to its rapid growth phase, spanning many aspects of the business, including leading growth strategy, and establishing and expanding Horizon's presence in the international markets. He demonstrated success in building organizations and maximizing their potential through both organic growth and business development. This makes him the right fit to lead Collegium. With Vikram as our CEO, we are well positioned for continued success in 2025 and beyond. In the third quarter of 2024, we announced and closed the Ironshore acquisition, which is expected to deliver on all our strategic objectives related to business development. In addition, we also drove strong revenue growth in our pain portfolio. Recent key accomplishments and highlights include: 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.

Scott Dreyer: Thanks, Mike. We're pleased to have completed our recent acquisition of Ironshore and are focused on integrating Jornay PM into our portfolio of commercial assets. Jornay PM expands our commercial presence into the large and growing ADHD market and is poised to become our lead growth driver. Jornay PM is highly differentiated as the only stimulant ADHD medication with convenient evening dosing. Jornay PM provides symptom control upon awakening in the morning and throughout the day, limiting the need for short-acting stimulant add-ons. It is 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 at school or at work. The ADHD market has grown 5% on average over the past four years. And since 2022, 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. And through the first three quarters of 2024, Jornay PM prescriptions grew 31.2% year-over-year. In addition, Jornay PM has a broad and growing prescriber base with 22,600 prescribers in the third quarter, up 25% since the third quarter of 2023. Jornay PM delivered strong prescription growth in the third quarter, up over 30% year-over-year. And we are seeing an acceleration during the back-to-school season. Our commercial team successfully navigated through the acquisition transition and took the necessary actions to maximize the opportunity during the back-to-school season. This is a critical time in the ADHD market when demand typically increases and therapy switching occurs, because patients currently being treated for ADHD often need a new option to control their symptoms. Leveraging the opportunity during the back-to-school season, average weekly prescriptions in October were 13,500, compared to 11,400 in July, an increase of 18%. This is an encouraging growth trajectory, and we're focused on continuing this momentum as we work to maximize the potential of Jornay PM. Prescription performance is in line with our expectations and the brand is on track to generate net revenue in excess of $100 million in 2024. With strong brand fundamentals and clinical differentiation, we see significant opportunity for Jornay PM. We continue to believe it is poised to become Collegium's lead growth driver, complementing our leadership position in responsible PAIN management, and we're committed to investing in Jornay PM to maximize the potential of this differentiated asset. Areas of focus include ensuring that the ADHD sales force is adequately sized to effectively reach our targeted HCPs and raising awareness of Jornay PM unique differentiated profile among caregivers and patients to motivate them to ask their HCP about Jornay PM. At Collegium, we take pride in being the leader in responsible PAIN management with a unique and differentiated portfolio of products for the treatment of pain. Belbuca, Xtampza ER and Nucynta ER collectively command over half of the branded ER market, demonstrating the ongoing strength and reach of our portfolio. The financial strength of Collegium has been fueled by the success of our PAIN portfolio and our commercial organization will continue to drive momentum and prioritize maximizing our pain products. Belbuca delivered another strong quarter with total prescriptions up 3.5% year-over-year, marking the fifth straight quarter of year-over-year prescription growth and driving record quarterly revenue. In addition, we've seen an acceleration in weekly prescriptions over the last few months. 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 product profile. Xtampza ER prescriptions were stable in the third quarter, in line with our expectations, and Xtampza ER's share of the OxyContin extended-release market achieved an all-time high of 38.1%. Average weekly prescriptions for Xtampza ER in September and October were up 1%, compared to the average weekly in July and August, showing some momentum as we enter the fourth quarter. We expect revenue growth for the full-year to be driven by improved gross to net, which has fueled the record net revenue in the third quarter. We're committed to educating physicians on Xtampza ER's differentiated label and capitalizing on Xtampza ER's strong access position in commercial and Part D. Our aspiration is to replace OxyContin utilization for appropriate patients due to Xtampza's superior abuse-deterrent properties and labeling. The Nucynta franchise is a key contributor to our portfolio. the positive developments for the franchise, including the authorized generic agreement with Hikma and the six-month pediatric exclusivity extension, along with the execution of our market access strategy, enable us to continue to manage the Nucynta franchise contribution in 2025 and beyond. We're committed to growing PAIN franchise revenue in 2025 and beyond through a combination of driving demand for our highly differentiated products and enhancing the profitability of each brand. In support of that goal, our contracting strategy is clear: 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.

Colleen Tupper: 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.

Michael Heffernan: 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?

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

Les Sulewski: 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.

Michael Heffernan: 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.

Scott Dreyer: 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 (NASDAQ:VRTX) 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.

Les Sulewski: Excellent. Thank you for that color.

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

David Amsellem: 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.

Michael Heffernan: Great. Thanks, David. Scott, do you want to take the first question on Jornay PM in gross to net?

Scott Dreyer: 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.

Colleen Tupper: 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.

Scott Dreyer: 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.

David Amsellem: Yes, that's helpful. Thank you.

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

Serge Belanger: 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.

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

Scott Dreyer: 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.

Serge Belanger: 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?

Scott Dreyer: 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.

Serge Belanger: Yes. Thanks for the call.

Scott Dreyer: Yes.

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

Oren Livnat: 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.

Michael Heffernan: 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.

Oren Livnat: 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?

Michael Heffernan: Yes. Thanks, Aaron. Scott, do you want to take that?

Scott Dreyer: 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.

Oren Livnat: 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?

Michael Heffernan: Yes. Scott, do you want to take that?

Scott Dreyer: 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.

Oren Livnat: 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?

Colleen Tupper: 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.

Oren Livnat: All right. Thanks so much.

Colleen Tupper: Thank you.

Operator: 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.

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

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

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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