COLL - NASDAQ

Greetings, and welcome to the Collegium Pharmaceutical First Quarter 2024 Earnings Conference Call. [Operator Instructions] 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.

Welcome to Collegium Pharmaceutical's First Quarter 2024 Earnings Conference Call. I'm joined today by Joe Ciaffoni our Chief Executive Officer; Colleen Tupper, our Chief Financial Officer, and Scott Dreyer, our Chief Commercial Officer; Mike Heffernan, the Chairman of our Board, will join us for the Q&A portion of the call. 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 and that we may not prevail in current or future litigation pertaining to our business. These risks and other risks of the company are detailed in the company's periodic reports filed with the Securities and Exchange Commission. Our future results may differ materially from our current expectations discussed today. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release including relevant non-GAAP reconciliations on our corporate website at collegiumpharma.com. I will now turn the call over to our CEO, Joe Ciaffoni.

Thank you, Chris. Good afternoon, and thank you, everyone, for joining the call. Today, we will discuss our financial performance during the first quarter and provide an update on our progress in 2024. At Collegium, we are focused on building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We strive to do good as we do well. During the first quarter, in support of our commitment to increase equitable access to STEM education and advance the next generation of life science leaders, we selected the first participants in the Collegium Pharmaceutical Scholarship Program. This new program awards 2 scholarships to high school seniors pursuing a STEM-related major at a U.S. university. Additionally, at our 2024 National Sales Meeting, we built wagons filled with toys for Nicklaus Children's Hospital in Miami, and we began the second year of our partnership with the Boston Red Sox and Science from Scientists. I'd like to recognize the Collegium team for their commitment to our mission and dedication to making a positive impact in the communities we serve. We are encouraged by the strong start to the year. 2024 is on track to be another record year for Collegium as we focus on operational execution to grow our core business and deploying capital to create value for our shareholders. Looking beyond 2024, key accomplishments across the pain portfolio, including growing momentum for Belbuca, a successful contracting strategy for Xtampza ER in the recently announced authorized generic agreement for the Nucynta Franchise meaningfully improve our outlook for 2025 and beyond. I am proud of the success that the Collegium team has achieved over the years. We've delivered consistently strong financial performance with a track record of growing the top and bottom line, executing value-creating acquisitions and being good stewards of capital. Collegium has exceptional company culture with a team committed to making a positive impact on the communities we serve. With a healthy balance sheet, disciplined capital deployment strategy and strong leadership, the company is well positioned for future growth. Earlier today, we announced that I will be stepping down as President and Chief Executive Officer of the company. To ensure a seamless transition, Mike Heffernan will serve as Interim President and CEO until a new CEO is appointed. Mike founded Collegium in 2002, served as President and CEO for over 15 years and is currently the Chairman of our Board. Given his past leadership at Collegium, he is well suited to lead the company during this transition period. It has been a privilege to work with many talented and dedicated colleagues at Collegium, and I am extremely proud of all that we have accomplished together. Collegium is in a strong position both financially and strategically, and I'm confident that we have the right leadership team in place to advance the business forward. I will now hand the call over to Colleen to discuss business highlights and financials.

Thanks, Joe. Good afternoon, everyone. In the first quarter of 2024, we delivered strong financial results, executed our capital deployment strategy and improved the outlook for our pain portfolio in 2025 and beyond. Key accomplishments and highlights in 2024 include: we accelerated momentum for Belbuca, growing prescriptions 4.2% and revenue 15% in the first quarter compared to the prior year period. We achieved gross to net for Xtampza ER of 53.6% in the first quarter, reflecting the immediate impact of the successful contract renegotiations completed last year. We strategically deployed capital and strengthened our balance sheet with the redemption of the remaining $26.4 million of our convertible senior notes due in 2026. Our Board authorized a $35 million accelerated share repurchase program, reinforcing our commitment to leveraging our $150 million share repurchase program to return capital to our shareholders. We entered into an agreement with Hikma Pharmaceuticals to distribute authorized generics of Nucynta and Nucynta ER, meaningfully improving our outlook in '25 and beyond. And we presented 4 scientific posters at the American Academy of Pain Medicine Annual Meeting in March and sponsored a CME program. Our focus in 2024 is on operational execution. We are on track to deliver record financial performance and deploy capital to rapidly pay down debt and return value to shareholders by opportunistically leveraging our share repurchase program. We delivered record Belbuca revenue driven by strong prescription growth of 4.2% year-over-year. We expect Belbuca revenue growth in 2024 to be fueled by full year prescription growth. Additionally, we expect ER Xtampza ER revenue growth to be driven by gross to net improvement. The Nucynta Franchise is a key contributor to our pain portfolio. As expected, we saw pressure on Nucynta Franchise revenue in the first quarter due to the elimination of the Medicaid cap by the American Recovery Act. On a full year basis, we expect some pressure on the Nucynta Franchise year-over-year revenues, with a return to relative year-over-year stability in 2025. The 2025 and beyond outlook for our pain portfolio continues to improve. The Medicare Part D redesign will serve as a tailwind for our pain portfolio, in particular, for Xtampza ER. The new patient population exclusivity for Nucynta and pediatrics granted in August 2023 was a significant event. We expect to receive a 6-month pediatric extension for the Nucynta Franchise in the second half of this year. In addition, we recently selected Hikma Pharmaceuticals to be our authorized generic partner for Nucynta and Nucynta ER, and that agreement further bolsters the value of the franchise. Finally, under the terms of our license of the orange book-listed patents that support the Nucynta Franchise, we expect our royalty obligations to decrease from 14% to 7% in July of 2025 and then to 0 upon the launch of the first authorized generic with Hikma. The competitive landscape relative to Belbuca has also improved with Chairman's announcement that for the fourth time, the FDA issued a complete response letter for their generic formulation of Belbuca. Following a banner 2023, we further strengthened our financial position in the first quarter of 2024 through record Belbuca revenue, managed operating expenses and another quarter of robust cash flows, strengthening our balance sheet. Financial highlights for the first quarter include: Net product revenues were $144.9 million in the first quarter, relatively flat year-over-year. Belbuca net revenue was a record $50.7 million, up 15% year-over-year. Xtampza ER net revenue was $45.8 million, down 4% year-over-year and Xtampza gross to net was 53.6%. As a reminder, gross to net is generally more favorable in the first quarter of each year due to the lower coverage gap expense, also known as the donut hole in Medicare coverage. As we move through the year, gross to net are expected to be less favorable in the second and third quarters and improved sequentially in the fourth quarter. Looking forward to 2025 with the Medicare Part D redesign, this dynamic will change and Xtampza ER will benefit from the phase-in period for small manufacturers. We expect the full year Xtampza ER gross to net to be between 56% to 58% this year, which is an improvement from 59.6% in 2023. Nucynta Franchise net revenue was $45.1 million, down 8% year-over-year. GAAP operating expenses were $42 million, down 20% year-over-year and adjusted operating expenses were $34.5 million, down 10% year-over-year. Net income for the first quarter was $27.7 million compared to a net loss of $17.4 million in the prior year period. Non-GAAP adjusted EBITDA was $92.4 million, up 5% year-over-year. GAAP earnings per share was $0.86 basic and $0.71 diluted in the first quarter compared to GAAP loss per share of $0.51 basic and diluted in the prior year period. Non-GAAP adjusted earnings per share was $1.45 in the first quarter, up 10% year-over-year. Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. As of March 31, we had $318 million in cash, cash equivalents and marketable securities. We generated another quarter of strong cash flows, enabling us to execute on our capital deployment strategy. With our strong financial performance in the first quarter, we're reaffirming our 2024 financial guidance. We expect net product revenues in the range of $580 million to $595 million. We expect adjusted operating expenses in the range of $120 million to $125 million and adjusted EBITDA in the range of $380 million to $395 million. We are confident in our ability to deliver on our financial commitments in 2024. Our outlook in 2025 and beyond has improved as well, given the Medicare Part D redesign that will serve as a tailwind to our portfolio, our Nucynta Franchise authorized generic agreement, the anticipated reduction in royalties paid on Nucynta franchise net sales and the improving competitive landscape for Belbuca. These positive developments increased the value of our pain portfolio as well as the intrinsic value of our company. We remain focused on creating long-term value for our shareholders through our capital deployment strategy. We are locked into rapidly deleveraging the balance sheet. To date, we have repaid $283.3 million of the Pharmakon loan, inclusive of $45.8 million in the first quarter, ending the quarter with net debt to adjusted EBITDA of less than 1x. In addition, the call option on our 2026 convertible notes was triggered by our strong stock performance, enabling us to redeem the $26.4 million total principal amount of the notes in all cash. We expect that transaction to settle in June. This strategic use of our capital strengthens our balance sheet by reducing debt, positively impacting full year diluted EPS and potentially reducing some technical short positions in our stock. We expect to repay an additional $137.5 million of the Pharmakon loan in the remainder of 2024, which would put us at a de minimis net debt to adjusted EBITDA ratio at year-end. We have a strong track record of returning in value to our shareholders through share repurchases and are committed to opportunistically leveraging our $150 million share repurchase program as part of our capital deployment strategy. The recently announced $35 million accelerated share repurchase program reflects our confidence in the strength of the business, which was recently bolstered by the positive developments related to our pain portfolio. We believe that there continues to be a disconnect between the intrinsic value of the company and our share price, which enables us to continue to opportunistically return value to our shareholders by leveraging our share repurchase program. I will now turn it over to Scott to give a commercial update.

Thanks, Colleen. At Collegium, we're proud to be the leader in responsible pain management and to offer a differentiated portfolio of products for the treatment of pain. Belbuca, Xtampza ER and Nucynta ER have a combined 50% share of the branded ER market, demonstrating the ongoing strength and reach of our portfolio. Our commercial organization is dedicated to making a positive impact on the lives of people living with pain in the communities we serve. Belbuca and Xtampza ER are well positioned for growth this year and the Nucynta Franchise continues to be a key contributor. We accelerated momentum for Belbuca in the first quarter. We achieved year-over-year Belbuca prescription growth of 4.2% during a time period where we have historically seen a decline in prescription volume due to typical first quarter dynamics where deductibles reset and out-of-pocket costs increase for patients. We're encouraged by these positive prescription trends and the impact of our strong commercial execution. We believe Schedule III products should be used before Schedule II and used more broadly. Belbuca is uniquely positioned because of its clinical differentiation as a Schedule III product with a broad range of doses for the management of severe and persistent pain that requires an extended treatment period. Our commercial team remains focused on delivering this message to health care professionals and strengthening execution. Our priorities for Belbuca include pulling through Belbuca's strong commercial access, improving push-through in Medicare Part D and expanding Medicare Part D coverage. Belbuca revenue growth in 2024 is expected to be driven by prescription growth. In the first quarter, as expected, we saw pressure on prescriptions driven by plans where Xtampza ER was removed from formulary on January 1 after our contract renegotiations as well as by the typical first quarter dynamics. We're encouraged that after the initial impact on prescriptions from those events, prescription trends are showing signs of stabilization beginning in March. Our priorities for Xtampza ER for the remainder of 2024 are clear. We're focused on stabilizing Xtampza ER prescriptions by educating physicians on Xtampza ER's differentiated label and pulling through Xtampza ER's strong access position in commercial and Part D plans. Our aspiration is to replace OxyContin utilization for appropriate patients. Importantly, we now have the gross-to-net headroom to secure new payer wins, which is a priority moving forward. The Nucynta Franchise is a key contributor to our pain portfolio. Tapentadol is a differentiated molecule with a proposed dual mechanism of action. It's viewed favorably and highly differentiated by health care professionals. Our market access strategy and our authorized generic agreement with Hikma enables us to manage the Nucynta Franchise contribution in a relatively stable manner year-on-year beginning in 2025 and beyond. In closing, we're encouraged by our performance in the first quarter and the trends that we're seeing across the pain portfolio. We're focused on achieving our 2024 commercial objectives through operational execution. I'll now turn the call back to Joe.

Thanks, Scott. Collegium is on track to deliver another year of record financial performance in 2024 while strategically deploying capital to create value for shareholders. Importantly, the outlook for the business in 2025 and beyond continues to meaningfully improve. Collegium is well positioned with a strong leadership team in place to drive future growth and create long-term value. I will now open the call up for questions. Operator?

[Operator Instructions] Our first question comes from David Amsellem with Piper Sandler.

So just on the transition, I guess a couple of questions. Why now, number one? And number two, does this at all signal any change in how you're thinking about business development priorities going forward? Or maybe put differently, does it signal any sort of daylight between how you're thinking about the direction of the company, broadly speaking, versus how the Board is thinking about it? I just want to better understand what is driving the change? Why now, and what it means for the direction of the company, particularly as it relates to your business development objectives?

Sure. So David, this is Joe. I'll start, and then I'll hand it off to Mike for some comments. So first off, in terms of the why now, I think it's really the right time for this leadership transition. The company is in a strong position. The company has a very strong culture of committed people. 2024 is on track to be a record financial performance. The outlook continues to improve in terms of 2025 and beyond. And I think importantly, we have a very strong and competent management team. In addition, I think we're in a unique position by having Mike as our Chairman, given his history and track record of success with the company to be able to step in on an interim basis. As it pertains to strategy, what I would emphasize, and I think this is important, the strategy of Collegium is a strategy that was collaboratively developed with the Board and the management team. And it's the management team that has been executing that strategy with the full support of the Board. So it's in no way indicative of change. And with that, I'll hand it off to Mike for any comments that he wants to share.

Great. Thanks, Joe. And David, thanks for the question. First, I'd like to thank Joe personally and on behalf of the entire Board for his tremendous leadership and his many accomplishments as the Collegium CEO for the last 6 years. When I stepped down as the CEO in 2018 and Joe took the role, I could have only hoped for the success that he has driven at the company. As Joe said, the company is in a very strong position financially and is poised for the next phase of growth. And the Board is confident that our ongoing search process will identify a world-class leader that will fill Joe's large shoes and take the company to the next phase of growth. We are committed to the strategy. We are committed to the capital deployment strategy, and we're committed to the BD strategy. So that remains unchanged, as Joe articulated.

And our next question comes from Tim Lugo with William Blair.

This is John on for Tim. So I want to say congrats on the progress with Belbuca. And I know in the past, you've said that that's a little bit more of a complicated product that's required some extra physician education. Just wondering if you can give us some idea of how much of that growth you contribute to the new sales initiative around improving that education? And maybe as a follow-up, how much more runway do you see for that product to grow?

Yes. So John, thanks for the question, and I'll hand those two questions off to Scott.

Yes. Thanks, John. I appreciate the question. And yes, we really are encouraged by the growth in the first quarter of 4.2% and how the momentum has continued to accelerate, especially given that the first quarter historically has growth headwinds with 1 quarter, 1Q dynamics. So we're encouraged by that. It is driven by execution. I mean we put a lot of work and energy into training our team to be as effective as they possibly can be and we will continue to do so. And look, we expect full year growth, we expect prescription growth to drive revenue growth going forward, and we're encouraged by what could be on the horizon.

Our next question comes from Serge Belanger with Needham & Company.

This is [ John ] on for Serge. First, regarding the agreement with Hikma. Can you provide any kind of context, I guess, beyond into potential other generic competitors who might enter the market in the future? And if that does happen, what the impact of those other generics could have on your deal with Hikma?

Sure. So [ John, ] thanks for the question. I'll start on that and then hand it off to Colleen. I think with the Hikma agreement, one, we're really excited to be partnered with an industry leader and well respected organization. When you look at Nucynta ER, what the Hikma agreement does is it secures a scenario beyond our base case. And as we've talked about in the past, we really want to bring focus to Teva as a domino that transcends the portfolio because whether they launch or not, will be an interesting event for the organization. To the degree that they don't, what the Hikma agreement enables is us to realize the vast majority of our upside economics. And Colleen, I don't know if there's anything that you want to add there.

Yes. Maybe just building up on that, I would say that this agreement gives us the certainty that there is only one potential entrant for Nucynta ER before 2028 and that's Teva. And if Teva doesn't launch, we secure nearly all of the value in our upside scenario due to the favorable profit share and the impact on the royalties.

Our next question comes from Les Sulewski with Truth Securities.

On Belbuca, how much of that 4.2% script growth was driven by the new Medicare Part D contribution? And then second, as we kind of look into the future of Xtampza renegotiations after your successful rounds for the past year or 2, would you expect those to be even more favorable or kind of in line and stable as we have progressed?

Yes. So Les, I'm going to hand the Belbuca question off to Scott.

Okay. Yes. Thanks, Les. So yes, when we look at Belbuca, that win was 1 million lives. So the vast majority of the growth is actually not driven by that win because it was a smaller amount of lives that were added. It's mostly through the overall growth of our portfolio.

And then Les, with regards to Xtampza ER, we're now in a position post having renegotiated 85% of all contracts this cycle, where how Xtampza grows year-to-year will be dependent upon what we accomplish in the payer landscape. So the first thing I want to emphasize is the confidence we have of Xtampza being able to consistently grow revenue each year as we move forward. So in 2025 and beyond. When you think about the headroom we have, when we report -- or when the team reports in November, Xtampza grow, if you'll then have an understanding whether it will be driven by new plans that drive prescriptions and/or renegotiations that also have the potential to improve margins. So it will be a year-to-year scenario but the thing that we are confident in is the ability to consistently grow revenue. And the one thing I would emphasize that is in 2025, we also get a pretty meaningful benefit from the Medicare Part D redesign, which will serve as a tailwind in particular for Xtampza.

And our next question comes from Oren Livnat with H.C. Wainwright.

Joe, you segued right into my question there. I was hoping to get a little more clarity around that Xtampza ER 2025 tailwind. Is that something that can help you renew prescription growth in 2025 and beyond? Or is that indirectly another economic or unit value benefit similar to what we've seen recently with step down gross to net? I have a follow-up.

Yes. Thanks for the question, Oren. I'll start by saying it's not a prescription benefit dynamic, and I'll hand off the Colleen to explain the impact of the Part D redesign, and in particular, in our portfolio, why Xtampza benefits.

Thanks for the question, Oren. So yes, the Medicare Part D redesign, the benefit that we speak about is all in the gross to net. So coverage gap or donut hole as we know it today, goes away completely and manufacturers and payers in the end, pay a larger proportion and patient out-of-pocket is limited. With the small manufacturer phase-in, our portion of that payment starts phasing in at 1% and goes up through a number of years until about 7 years through. So that's what that refers to is all gross to net benefit, and it's associated with the phase-in for small manufacturers starting at once this point and going up from there.

So just -- so I'm clear, philosophically or essentially or at a high level we're talking about the amount you have to pay in as a small company is less than the amount you've been having to cover in the donut hole essentially?

That's right. It will be less than what we have to cover this year and then phase back in over a number of years up to the level we pay in 2024.

Okay. And speaking of gross to net, your Q1 Xtampza gross was a little higher than I modeled. I can't speak for what you were expecting. Is it possible that this year it's going to have a flatter cadence or a narrower range through the year than maybe we saw last year or 2?

Yes. First I would say Xtampza is performing in line with our expectations. The Q1 growth came at a 53.6%. You will still see in Q2, Q3 that eroded a bit because of the donut hole impact. But you're right, it's not quite as steep of an impact in the quarter. And from a full year, we're guiding to 56% to 58%, which is an improvement over nearly 60% last year.

Okay. And just I -- you cut out earlier on the call for me. What were you saying about someone getting a CRL on a generic Belbuca. Sorry, make you repeat that.

Yes. Chemo, which was the third ANDA filer for Belbuca has recently received its fourth CRL.

Okay. And there's no fourth or fifth filer, if I recall, right? So we have clarity. If they're not there, it's just between Teva with an uncertain launch when their time comes and Alvogen blocked for a long time, correct?

Until 2032.

And Joe, it's been fun working with you, man.

Thanks, Oren. It's been a lot of fun working with you, too.

Thank you, and there are no further questions at this time. I will now hand the floor back to Joe Ciaffoni for closing remarks. Thank you.

Thank you, everyone, for joining the call today. I hope you all have a great evening.