Assertio Holdings, Inc. ($ASRT)

Ladies and gentlemen, thank you for standing by. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the Assertio Holdings Fourth Quarter and Full Year 2025 Results Conference Call. [Operator Instructions] And I would now like to turn the conference over to Daniel Santos with Longacre Square Partners. You may begin.

Thank you. Good afternoon, and thank you all for joining us today to discuss Assertio's fourth quarter 2025 Financial Results and Business Update. The news release covering our results for this period is now available on the Investor page of our website at investor.assertiotx.com. I would encourage you to review the release and tables in conjunction with today's discussion. Please note that during this call, management will make projections and other forward-looking statements regarding our future performance. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in this afternoon's press release as well as the Assertio's filings with the SEC. These and other risks are more fully described in the Risk Factors section and other sections of our annual report on Form 10-K and in our Form 10-Q filings. Our actual results may differ materially from those projected in the forward-looking statements. Assertio specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. With that, I will now turn the call over to Mark Reisenauer, Chief Executive Officer. Please go ahead.

Well, thank you to everyone for joining us today. Before we dive into our fourth quarter and full year 2025 results, I want to take a moment to share 3 early observations from my time as CEO and provide some color on where I see opportunities ahead. Since I became CEO in October, I've had the opportunity to meet with team members at every level of our organization and several things have come into focus for me. First, I believe we have a significant revenue opportunity in our core asset, Rolvedon, which is reflected in our 2026 guidance. Second, we have an experienced commercial operation with strong market access, sales and contracting capabilities that we can leverage to bring other products to market successfully. And third, our prior strategy of acquiring on-market specialty products is no longer capital efficient or a sustainable strategy to fuel growth. Now let me expand on those points a little bit. Since we acquired Rolvedon in 2023, the team has worked to streamline our organization, consolidating regulatory, distribution and contracting functions and bringing Rolvedon manufacturing under our consolidated commercial label to drive operational efficiencies. With that integration fully complete in quarter 4, 2025 and we have positioned the product for commercial success, including maintaining a leading market share position. As we explained last quarter, as part of this Rolvedon integration and transition to a new distribution partner, we pulled forward 2 quarters of demand to ensure uninterrupted patient supply during the transition. Regular sales of the newly labeled Rolvedon are expected to begin in the second quarter of 2026, after which we expect continued demand growth and an acceleration in sales compared to the prior year, which A.J. will discuss in more detail when he goes over our 2026 guidance. Given that our IP protection goes out to 2039, we continue to view Rolvedon as a long-term revenue opportunity. And as such, we will prioritize implementing a meaningful life cycle management strategy. Rolvedon is a great example of what's possible with strong commercial execution. We see significant opportunities leveraging the commercial organization we've built around Rolvedon to bring other products to market. Our team has broad capabilities across marketing, sales, market access and distribution, which we can leverage to maximize access and reach of other products in the oncology market. Paul has already led the organization through most of the heavy lifting, and our focus now is on finding the right products to acquire and grow, which brings me to my third point, our strategy. Historically, Assertio has pursued a strategy of acquiring on-market specialty products. While these assets can provide immediate cash flow, competition for these opportunities has intensified in recent years, and acquisition prices have increased. This approach has delivered some successes for the company, including Rolvedon. However, it has also highlighted the importance of being disciplined in how we allocate capital and commercial resources. For example, while Sympazan continues to serve patients with a differentiated formulation, the returns on our investments to grow the product have been lower than expected. As a result, we do not believe that further incremental investment behind the asset is warranted relative to other higher growth opportunities for capital deployment. That experience reinforces our focus on being highly selective in pursuing assets where our commercial platform can drive attractive and sustainable returns. With this in mind, let's talk about where Assertio goes from here. The core of our strategy will continue to be ensuring the success of Rolvedon and leveraging the operational efficiencies we've built around it through our integration efforts. In the near term, that means we'll focus on driving Rolvedon sales growth and implementing a comprehensive LCM strategy to maximize our long-term opportunity. On the BD side, we're going to be much more focused on finding opportunities that leverage our existing Rolvedon footprint and capabilities. Expanding our presence in oncology is a natural next step for us. We see multiple pathways to growth through targeted business development, including individual product acquisition, commercialization agreements, licensing or technology agreements, and/or potential business combinations. We will be disciplined in our approach and focus on both on market and development stage assets that meet our investment and return criteria. We don't have anything to announce on this front yet, but we continue to search to see what opportunities are available. I'm proud to say we're entering this next phase from a position of strength with a solid balance sheet, and a core asset with meaningful runway ahead. Before I turn it over to Paul, I want to thank our team for their hard work and for embracing recent changes with enthusiasm and focus. It makes a difference, and it reinforces my confidence in what we can deliver going forward. With that, I'll turn it over to Paul, who can provide an update on our portfolio and operations.

Thank you, Mark. From a commercial and operations perspective, our focus over the past year has been to align our commercial resources to optimize cash flow from our tail assets while continuing to support the growth of Rolvedon. Starting with Rolvedon, the integration of the product from Spectrum into the Assertio platform is now complete, and we will continue to integrate the remaining products in our portfolio during 2026. For Rolvedon, this included transitioning the product on to the Assertio label and fully integrating the commercial, operational and market access infrastructure required to support the product going forward. Importantly, this transition has been seamless from both the customer and patient perspective, which was a top priority for our organization. During the fourth quarter, we saw the expected pull-through of the large purchases that were executed in the third quarter and those dynamics are progressing as planned. From a demand perspective, Rolvedon continues to perform well, particularly within the community oncology clinic segment where we maintain strong share. Since the product launched in late 2022, we have continued to see new accounts begin purchasing Rolvedon each quarter, which reinforces our confidence that there remains opportunity to further expand awareness and utilization. To support the next phase of growth, we have also executed a number of personnel and process enhancements across the organization. These changes are designed to further strengthen our community oncology focus, expand our reach with key clinics and improve the coordination between our field teams and market access capabilities. We believe these adjustments position us well to continue expanding Rolvedon's presence within our target accounts. At the same time, we remain disciplined in how we manage the remainder of our portfolio. Our approach is to optimize the cash flow generated by our tail assets while prioritizing commercial investment behind Rolvedon and other future growth opportunities. Let me now spend a moment discussing the commercial capabilities we built and how they position Assertio to bring additional products to market. Over the past few years, we have developed a focused commercial platform centered on the community oncology channel. Our field organization includes a national team of corporate account managers engaging with clinics across the country working directly with providers and practice administrators to encourage product awareness and adoption. That effort is complemented by a national accounts team dedicated to contracting with group purchasing organizations and aggregators, which enables us to efficiently expand access across large networks of oncology practices. We also have significant expertise in trade and distribution and maintain strong relationships with distributors, GPOs, aggregators and clinic customers which helps ensure efficient product flow and broad market access. Supporting the field organization is a fully integrated patient services infrastructure, including both the hub services platform, and field reimbursement specialists who work with providers to help navigate coverage and reimbursement processes and support patient adds to therapy when it is prescribed. Taken together, these capabilities create a scalable commercial infrastructure that we can believe -- that we believe can support not only our current portfolio but also additional assets in the future. As we look ahead, we believe this platform positions Assertio well to incubate and commercialize additional products that fit within our existing commercial footprint. Overall, we believe the operational progress we've made over the past year strengthens the foundation of the business well to both continue growing Rolvedon and thoughtfully expand the portfolio over time. With that, I'll now pass the call over to Ajay, who will cover the financial results. A.J.?

Thanks, Paul. I'll now walk through our financial results for the fourth quarter and full year 2025. Total product sales in the fourth quarter were $12.8 million compared to $29.6 million in the prior year, primarily driven by the timing of channel inventory associated with the previously disclosed Rolvedon sell-in. While Rolvedon net sales products were minimal at $0.4 million in the fourth quarter, down from $15.4 million in the prior year quarter. Underlying demand for Rolvedon remained stable and our 2026 outlook reflects a return to a more normalized sales pattern beginning in the second quarter with newly labeled Rolvedon. Sympazan sales were $3.1 million in the fourth quarter, up from $2.5 million in the prior year, reflecting higher volume and a favorable payer mix. Indocin sales in the fourth quarter were flat year-over-year at $5.5 million as higher net pricing offset expected volume pressure from generic competition. Gross margin improved to 75% compared to 61% in the prior year, primarily driven by a higher mix of Indocin sales and the prior year inventory write-downs not repeating. Turning to operating expenses. Reported SG&A expenses were $13.1 million, down from $21.4 million in the prior year, reflecting lower legal expenses following completion of litigation-related initiatives as well as reduced personnel costs following restructuring actions taken in the fourth quarter. GAAP net income for the fourth quarter was a loss of $11.9 million compared to a loss of $10.5 million in the prior year, and adjusted EBITDA for the fourth quarter was negative $4.1 million compared to a positive $3.4 million in the prior year. As of December 31, 2025, cash, cash equivalents and short-term investments totaled $63.4 million compared to $93.4 million at September 30, 2025. This decrease primarily reflects a temporary increase in net working capital associated with the Rolvedon sell-in. Specifically, this was driven by an expansion of accounts receivable due to extended terms required to complete the sell-in as well as an increase in accrued rebates as that inventory pulls through the channel. We expect this working capital variability to continue through the first quarter as these balances are settled. However, we anticipate that working capital and cash flows will return to normalized levels by the end of April, aligning with the expected start of newly labeled Rolvedon sales in the second quarter. Now on to full year results. Total product sales were $117.1 million above the high end of the updated guidance range we provided last quarter. Rolvedon sales were $68.2 million, up from $60.1 million in the prior year. Indocin net product sales were $18.9 million for 2025, reflecting expected volume and pricing impacts from generic competition. Gross margin was 70% in 2025, up from 68% in the prior year, primarily due to prior year inventory write-downs and step-up amortization expenses not repeating. Full year adjusted EBITDA was $22.7 million, up from $18.3 million in 2024 and driven primarily by lower SG&A expenses and favorable gross margin. I'll conclude with our outlook for 2026. For fiscal 2026, we are initiating revenue guidance in the range of $110 million to $125 million, and adjusted EBITDA guidance between $28 million and $40 million. As we look at our fiscal '26 revenue guidance of $110 million to $125 million, it is important to understand the underlying dynamics of our primary growth driver, Rolvedon. While we expect natural declines in our legacy tail assets, our strategic focus for 2026 is maximizing Rolvedon sales to offset these headwinds. The guidance range reflects varying scenarios for overdone, specifically regarding pricing, gross to net and volume acceleration. At the upper end of the range, we anticipate favorable market dynamics and increased market share. For comparison purposes, it is important to note that our fiscal '25 reported Rolvedon revenue included approximately 5 quarters of wholesaler shipments due to the Q3 sell-in. In fiscal '26, our reported figures will reflect 3 quarters of wholesaler shipments as regular sales of the newly labeled Rolvedon are expected to begin in the second quarter. On a normalized quarterly basis, we expect growth in Rolvedon ex factory wholesaler shipments driven by higher end customer demand volume. Our fiscal '26 total revenue guidance reflects underlying revenue growth in Rolvedon. At the midpoint of our guidance range and above, we expect Rolvedon's revenue growth to fully offset the year-over-year reduction in Rolvedon shipment quarters and anticipated declines in our tail assets. Turning to profitability. We are forecasting fiscal '26 EBITDA -- adjusted EBITDA between $28 million and $40 million, this represents year-over-year expansion in margin compared to our results in fiscal '25. This step change in profitability is driven by 2 primary levers: high-margin revenue growth. Rolvedon's growth is highly accretive. Our strategy has a direct fall-through effect on margins. Furthermore, we believe we can capture additional volume through our existing commercial infrastructure without requiring incremental OpEx. Structural cost savings, we are realizing the full year benefits of several key initiatives. These include reduced year-over-year litigation expenses, the successful decommercialization of Otrexup and a leaner personnel structure following our Q4 restructuring activities. As we move through the year and gain greater visibility following the resumption of Rolvedon sales, we look forward to providing updates on our progress and our potential to perform towards the upper end of the range. With that, I will turn the call back to Mark.

To wrap up, as I highlighted earlier, we believe Assertio is operating from a position of strength. Rolvedon remains a significant long-term opportunity with meaningful runway ahead, supported by the commercial platform we've built and our strong relationships across the community oncology market. At the same time, we're taking a disciplined approach to capital allocation and business development as we evaluate opportunities that can leverage our existing capabilities and drive sustainable growth. Overall, our focus remains clear: execute on the growth potential of Rolvedon, leverage our commercial infrastructure and create long-term value for patients and shareholders. With that, I'll turn the call back over to the operator so we can begin to answer questions.

[Operator Instructions] And our first question comes from the line of Thomas Flaten with Lake Street Capital Markets.

Back to the strategic priority of focusing on the oncology space, maybe you could help us understand a little bit better what types of assets are you looking at? Are you looking for commercial assets, primarily supportive care? Would you do therapeutic? Any interest in taking on board pipeline projects? And obviously, there would be an implication there will be some R&D spend, but maybe a little bit more detail on that would be super helpful. .

Sure. Thanks for the question, Thomas. So in terms of the scope of what we would be looking for in the oncology space, I think maybe some additional criteria that we would use as we evaluate. I think it would be on market, certainly. It would be late-stage development past proof-of-concept. Certainly, we'd be looking at therapeutics primarily. And I think that's probably a good starting point of how we're looking at the oncology opportunity.

And just a follow on from that then. With the current commercial infrastructure you have in place, are there any incremental investments that you see being required to bring on board the types of products you want, for example, expanding the sales force? Or do you feel that the commercial infrastructure today is pony attractive enough for potential partners? .

Yes. Thomas, I think it would be a small increment most likely in terms of what we already have. I think we have a great base, but it would be a small incremental investment likely as we bring an investment on.

And our next question comes from the line of Naz Rahman with Maxim Group. .

Congrats on the progress. Just especially one for the follow-up. Considering a roll-on growth been in the last couple of years in '24 and '25 the sales, what kind of gives you confidence in this guidance and growth considering that a lot of that sales would really occur over 3 quarters? But could you talk a little bit more about the initiatives you plan on implementing in '26 to sort of reach that growth level? And is part of that -- is there a plan to sort of expand away from the community setting? Or are you planning on, I guess, further penetrating in the community setting at this point?

Okay. Thank you, as for your questions. I'll kick it off and then I'll turn it over to Paul for some additional color commentary. But the first part of your question, what gives us confidence in the growth. If you look at demand growth, in 2025 full year, it was 32% year-over-year compared to 2024. So independent of the sell-in, the underlying demand growth for the year was still strong, and we would expect that continued demand growth, maybe not that same level, but certainly, we will continue to add new accounts in 2026, much like we've done in 2025. Your second question, as it related to -- if you could repeat it again, that was -- because you were breaking up a little bit.

Yes. Is there a plan to sort of expand away from community setting at this point. I believe this was discussed or talked about before? Or is the plan currently just continue to further penetrate within the community setting? .

Yes. Okay. That's much clearer now. The plan would be to continue to focus on the community, Medicare Part B setting. We have a very high market share there. We're a leader in that space, and we think there is further room to grow. We'll also continue to evaluate some of the other segments and make targeted investments if we think they're warranted. But the growth, we believe, continues to come primarily from the area where we already have a leading market share. And I don't know if there's anything, Paul, that you would want to add. .

No, I think that covers it. I think the growth we're going to achieve is going to be through new accounts. We've seen growth every quarter since we launched the product, and we do see new opportunities out there to win some additional accounts, which is going to drive a lot of the growth. And then you're right, Mark, the focus is really going to be in the community oncology space, Medicare Part B. Having said that, I would say we're open to other opportunities if the opportunities present themselves. But right now, that's going to be the focus. .

And our next question comes from the line of Scott Henry with Alliance Global Partners.

I want to dig in a little bit on Rolvedon just to fully understand. So in third quarter of '25, you sold into the channel because you were switching labels, which caused Q4 to be virtually nothing. And it sounds like -- I'd love to hear what your thoughts are for Q1. I don't think it's going to be meaningful. But now you're switching to the second version. So my question is, will there be any stocking of the relabeled product? Or would you expect revenues to simply reflect demand in 2026? Just trying to get a sense of what the levers are that are setting you up for a pretty good number for 2026.

Yes, Scott, Paul here. I'll answer the question. So right now, we're expecting a relatively smooth transition from the old label to the new label. What I mean by that is that the product that we shipped at the end of the third quarter is getting pulled through in demand in the fourth quarter and will continue to be pulled through in the first quarter of 2026. And then at that point, we will shift over to the new label and there will be a transition to kind of building the channel with that new label. And that's really the start in the second quarter in earnest of 2026. .

Well, the question is when an account switches to the new label, will they fill in some inventory? Or will they just basically be replacing the old version with the new version on kind of a steady-state basis? It's really very specific, do you expect channel inventory to build in 2026.

We don't expect channel inventory to build. And I would say is generally speaking, we expect that the quarterly demand will be generally align with the quarterly shipments in 2026.

Okay. That's great and particularly helpful. And then on Indocin, it looked like a pretty good quarter in fourth quarter of million within your guidance, how do you think about that product? You down marginally, down substantially, just because 2025 shaped up pretty good for the second half for Indocin.

Yes. Thanks, Scott. This is A.J. I can take that one. Yes, you're absolutely right. We especially like the fourth quarter results of it. Obviously, we're always cognizant that it is competing in a highly competitive landscape with the generic competitors. Obviously, Indocin is not protected, so we don't have visibility -- direct visibility into once new generics will enter. However, from Market Intelligence, we are expecting at least one additional generic in '26. So naturally, we are expecting a decline in that tail asset, as I had kind of said in my guidance commentary. Therefore, we do expect a year-over-year decline in that -- what we will try to manage is as we've been doing since one generic in '23 is to try to maximize the profitability from that product. .

Okay. And A.J., since I got you on the line, that $13 million in SG&A in Q4 was -- looks pretty lean relative to past quarters. how reflective do you think that quarterly rate is going forward? I know there's a lot of onetime events that work their way in there, but I mean does that $13 million seem representative to you?

Yes. The $13 million will have had kind of some onetime benefits as well from the restructuring activities we took However, we do generally see a step down in the adjusted SG&A figures when you look at it, excluding stock compensation, DNA, et cetera, we do see a step down from '25 to '26, especially given the derisking from a litigation expense perspective, the TRx of commercialization and some of the personnel. We do estimate that to be at least in the range of $3 million to $5 million on a year-over-year basis.

Okay. And if I could just slip in one final question. I apologize if I went over the limit. For Mark, I think it's a good observation that assets are pricey right now and probably a good idea not to be a buyer in an environment like that. But the flip side of that coin is if our assets are expensive, perhaps you want to be a seller. So would you consider divesting assets or even putting the company up for sale? I mean, I know you will always consider that as a public company. But I wanted to get your thoughts on that.

Yes. Thanks for the extra question, Scott. I'll let it slide this time. I'm just kidding. The about what we consider divesting. That's something we do continuously, I would say, Scott, we're always evaluating whether an asset makes sense with us or would it do better with another company. So that's a continuous process, and I would expect we would evaluate that as we have always done throughout the year, but no specific plans currently.

Okay. And I assume that would be -- that would include evaluating selling the company as a whole as well, correct? .

I think -- well, as a public company, obviously, that can always happen. And so I don't think that's something we're necessarily actively doing. But it's as a public company that can happen at any time. .

Okay. And congratulations on the strong outlook for next year.

And our final question comes from the line of Ram Selvaraju with H.C. Wainwright.

Congratulations on all the recent progress. I was wondering if you could just give us some more granularity regarding the underlying expectations concerning the top end of your 2026 guidance, specifically as this pertains to Rolvedon net sales. Can you give us some more information with respect to that? And also, if you could give us a sense of how you are thinking about the long-term future of the product. and what you anticipate potential achievable peak annual sales in the U.S. could be a couple of years down the road? And then also with respect to possible BD activities, when you think about potential products within the oncology domain that could be synergistic with or readily combinable with Rolvedon when you think about how your sales and marketing infrastructure is set up to promote that product. Can you give us any additional context around which specific subcategories of the oncology space would likely make the most sense to look for complementary assets to Rolvedon?

Let me take the first half, and then I'll let Mark answer the second part of your question. From a guidance perspective, we don't typically give out kind of product level guidance. But obviously, as you think about our range and you've seen our fiscal '25 results, directionally, the way you should kind of think about it is we are expecting, as I said in my commentary, year-over-year growth on oven it's just going to be a reflection of what is the magnitude of that growth. And as the year progresses, especially with the launch of the newly labeled product in the second quarter, we hope to provide a little more granularity on that. But generally, what we're targeting at the midpoint of the range and above is the year-over-year growth should more than offset the degradation we expect in our tail assets, specifically Indocin. And then additionally, it should more than offset combined with the shipment quarter differences we had year-on-year. So that's generally how we're thinking about it. I think our long-term potential on Rolvedon, as we've indicated in the past, there is a strong optimism that capabilities of that product. does have potential to reach -- exceed $100 million. We've looked at various ranges above that. There's opportunities to reach $100 million to $130 million, and even beyond that. But generally, we're at least from a step approach is targeting for it to reach above $100 million is kind of the near-term optimism we have in the next few years.

Just very quick I wanted to get some quick clarity on 1 thing that you said, A.J. Is it correct to assume that even the upper end of your guidance assumes some degree of degradation erosion in indecent sales relative to 2025. Is that a correct assumption?

That is a correct assumption. .

Yes. And then just to cover off on your last question, what specific subcategories might we look at in the oncology space that would be logical given our existing footprint. And let me start first with the footprint and then I'll go to the subcategory. So the footprint we have and the community oncology space, which is actually, by the way, where most cancer patients are treated, is actually a great place for any therapeutic, whether it's for liquid tumors or solid tumors. So I think that's one of the benefits of our existing footprint, the community oncology space those physicians do treat all types of cancers. So from our standpoint, then what that translates to is a therapeutic compound that could be for liquid or solid tumors. I think that's the simplest way to think about it. .

And ladies and gentlemen, that concludes our question-and-answer session as well as today's call. We thank you for your participation, and you may now disconnect.