Assertio Holdings, Inc.

Assertio Holdings, Inc.

ASRTยทNASDAQ

$23.45

-0.043%
HealthcareDrug Manufacturers - Specialty & Generic

Assertio Holdings, Inc., a specialty pharmaceutical company, provides medicines in the areas of neurology, hospital, and pain and inflammation. Its pharmaceutical products include INDOCIN, an oral solution and a suppository form for the treatment of moderate to severe rheumatoid arthritis, including acute flares of chronic disease; ankylosing spondylitis and osteoarthritis; and acute painful shoulder and gouty arthritis. It also provides CAMBIA, a non-steroidal anti-inflammatory drug (NSAID) for the treatment of migraine, nausea, photophobia, and phonophobia; Zipsor, a NSAID for relief of mild to moderate acute pain; SPRIX, a NSAID for the short term management of moderate to moderately severe pain that requires analgesia at the opioid level; and Otrexup, a single-dose auto-injector containing a prescription medicine and methotrexate that is used to treat adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis. The company was formerly known as Assertio Therapeutics, Inc. and changed its name to Assertio Holdings, Inc. in May 2020. Assertio Holdings, Inc. was incorporated in 1995 and is headquartered in Lake Forest, Illinois.

At a Glance

Live Snapshot
Market Cap$151.54M
EPS-4.7400
P/E Ratio-4.95
Earnings Date07/30/2026

Earnings Call Transcript

ASRT โ€ข 2025 โ€ข Q4

Operator
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, Inc. Fourth Quarter and Full Year 2025 Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star 1 a second time. Thank you. I would now like to turn the conference over to Daniel Santos with Longacre Square Partners. You may begin.
Daniel Santos
Thank you. Good afternoon, and thank you all for joining us today to discuss Assertio Holdings, Inc.'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 Assertio Holdings, Inc.'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-Ks and in our Form 10-Q filings. Our actual results may differ materially from those projected in the forward-looking statements, Assertio Holdings, Inc. 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 L. Reisenauer, Chief Executive Officer. Please go ahead.
Mark L. Reisenauer
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 three early observations from my time as CEO and provide some color on where I see opportunities ahead. Since I became CEO in October, I have 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, Robodon, 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 Movadon in 2023, the team has worked to streamline our organization, consolidating regulatory, distribution, and contracting functions and bringing Robodon manufacturing under our consolidated commercial label to drive operational efficiencies. With that integration fully complete in Q4 2025, we have positioned the product for commercial success, including maintaining a leading market share position. As we explained last quarter, as part of this Robodon integration and transition to a new distribution partner, we pulled forward two quarters of demand to ensure uninterrupted patient supply during the transition. Regular sales of the newly labeled ROBODON are expected to begin in the second quarter 2026, after which we expect continued demand growth and an acceleration in sales compared to the prior year, which AJ will discuss in more detail when he goes over our 2026 guidance. Given that our IP protect goes out to 2039, we continue to view Rolledon as a long-term revenue opportunity and as such, we will prioritize implementing a meaningful life cycle management strategy. Rovodon is a great example of what is possible with strong commercial execution. We see significant opportunities leveraging the commercial organization we have built around Rolvodon 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 Holdings, Inc. 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 roll it down. However, it has also highlighted the importance of being disciplined in how we allocate capital and commercial resources. For example, while SYMPA
Ajay Patel
Primarily driven by the timing of channel inventory associated with the previously disclosed Rovodon sell-in. While Rovodon 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 ROVEDON remained stable, and our 2026 outlook expect growth strong. We growth in half beginning in the second quarter with newly labeled Robodon. SYMPA
Mark L. Reisenauer
To wrap up, as I highlighted earlier, we believe Assertio Holdings, Inc. is operating for position of strength. Robodon remains a significant long-term opportunity with meaningful runway ahead, supported by the commercial platform we have built and our strong relationships across the community oncology market. At the same time, we are 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 Rolvsodon, leverage our commercial infrastructure, and create long-term value for patients and shareholders. With that, I will turn the call back over to the operator so we can begin to answer questions. Thank you.
Operator
And we will now open for questions. If you have dialed in and would like to ask a question, please press 1 on your telephone keypad to raise your hand and join the queue. If you are called upon to ask your question and are listening via speakerphone on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. To be able to take as many questions as possible, we ask that you please limit yourself to one and one follow-up. Again, it is star one to join the queue. And our first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Your line is open.
Thomas Flaten
Hey, good afternoon. I appreciate you guys taking the questions. 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 you are looking at. Are you looking for commercial assets, you know, primarily supportive care? Would you do therapeutic? Any interest in taking onboard pipeline projects? And, obviously, there would be an implication that there would be some R&D spend, but maybe a little bit more detail on that would be super helpful.
Mark L. Reisenauer
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 would be looking at therapeutics. Primarily. And I think that is probably a good starting point of how we are looking at the oncology opportunity.
Thomas Flaten
And just to 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 or do you feel that the commercial infrastructure today is plenty attractive enough for potential partners?
Mark L. Reisenauer
Yeah. That was 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. Got it. Appreciate that. Thank you.
Operator
And our next question comes from the line of Nazibur Rahman with Maxim Group. Your line is open.
Nazibur Rahman
Hi, everyone. Congrats on the progress. Thanks for taking my questions. Just especially one with a follow-up. Considering what Robonaut's growth been the last couple years in 2024 and 2025 of sales, what kind of gives you confidence in this guidance and growth considering that a lot of that was really occur over three quarters. Could you talk a little bit more about the initiatives you plan on implementing in 2026 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 just planning on, I guess, further penetrating with the community setting at this point?
Mark L. Reisenauer
You, Nas, for your questions. I will kick it off, and then I will 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 you know, 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 have done in 2025. Your second question as it related to if you could repeat it again, that is because you were breaking up a little bit. Sorry. Just gonna keep setting. Yeah. Is there a plan to sort of expand away from resetting at this point? I believe this is the discussed or talked about before, or is the plan to currently just continue to further penetrate within the community setting? Yeah. Okay. Thank you. It is that is much clearer now. The plan would be to continue to focus on the community Medicare Part D setting. We have a very high market share there. We are a leader in that space, and we think there is further room to grow. We will also continue to evaluate some of the other segments and make targeted investments if we think they are warranted. But the growth, we believe, continues to come primarily from the area where we already have a leading market share. And I do not know if there is anything, Paul, that you would want to add.
Paul Schwichtenberg
No. I think that covers it. I think the growth we are gonna achieve is gonna be through new accounts. We have seen growth every quarter since we launched the product. And we do see new opportunities out there to win some additional accounts, which is gonna drive a lot of the growth. And then I you are right, Mark. The focus is really gonna be on the community oncology space, Medicare Part B. Having said that, I would say, you know, we are open to other opportunities if the opportunities present themselves. But right now, that is gonna be the focus.
Operator
And our next question comes from the line of Scott Henry with Alliance Global Partners. Your line is open.
Scott Henry
Thank you, and good afternoon. I want to dig in a little bit on Rolvodan just to fully understand. So in '5, you sold into the channel because you were switching labels, which caused Q4 to be virtually nothing. And it sounds like I would love to hear what your thoughts are for Q1. I do not think it is going to meaningful. But now you are 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 for pretty good number. For 2026.
Paul Schwichtenberg
Yeah, Scott. I will this is Paul here. I will the question. So right now, we are expecting a relatively smooth transition from the old label to the new label. What I mean by that 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, 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 is really gonna start in the second quarter in earnest of 2026. If that addresses your question.
Scott Henry
Well, the question is when 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 is really very specific to expect channel inventory to build in 2026?
Paul Schwichtenberg
We do not expect channel inventory to build, and I would say it is generally speaking, we expect that the quarterly demand will be generally aligned with the quarterly shipments in 2026.
Scott Henry
Okay. That is great and particularly helpful. And then on EndoSyn, looked like a pretty good quarter in '25. 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 Indocent.
Ajay Patel
Yeah. Thanks, Scott. This is AJ. I can take that one. Yeah. You are absolutely right. We especially like, you know, the fourth quarter results of it. Obviously, we we we are always cognizant that it it is not it is competing in a highly competitive landscape with the generic, competitors. Obviously, the Indocin is not protected so we do not have visibility direct visibility into one new generics will enter. However, from our market intelligence, we we are, expecting at least one additional generic in 2026. 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, you know, as as we have been doing since it went generic, in '23 is to try to maximize the profitability from that product.
Scott Henry
Okay. And, AJ, since I got you on the line, that $13 million in SG&A in Q4 looks pretty lean relative to past quarters. How reflective do you think that quarterly rate is going forward? I know there is a lot of onetime events that work their way in there, but I mean, does that $13 million seem representative to you?
Ajay Patel
Yeah. 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, D&A, etcetera. We do see a step down from 2025 to 2026, especially given the derisking from a litigation expense perspective. Though trucks have commercialization and some of the personnel we do estimate that to be at least in the range of $3 million to $5 million on an year-over-year basis.
Scott Henry
K. And if I could just slip in one final question. I apologize if I went over the limit. For Mark, I think it is 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 if assets are expensive, perhaps you want to be a seller. So would you consider divesting assets or even, you know, 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. Thank you.
Paul Schwichtenberg
Sure. Thank yeah. Thanks for the extra question, Scott. We will let it slide this time. I am just kidding. The question about would we consider divesting, that is something we do continuously. I would say, Scott. We are always evaluating whether an asset makes sense with us or would it do better with, you know, another company. So that is a continuous process, and I would expect we would evaluate that as we have always done throughout the year. But no specific plans currently.
Scott Henry
Okay. And I assume that would be that would include evaluating selling the company as a whole as well. Correct?
Paul Schwichtenberg
I think well, as a public company, obviously, that can always happen. And so do not think that is something we are necessarily actively doing, but it is as a public company, that can happen at any time.
Scott Henry
Okay. Well, thank you for taking the questions, and congratulations on the strong outlook for next year.
Paul Schwichtenberg
Thanks, Scott.
Operator
And our final question comes from the line of Raghuram Selvaraju with H. C. Wainwright. Your line is open.
Raghuram Selvaraju
Thanks very much for taking my questions and 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 Rovidone net sales? You know, 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 US could be, you know, a couple years down the road. And then also with respect to possible BD activities, when you think about potential products within the on domain that could be synergistic with or readily combinable with rolvidone 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 Rovidar. Thank you.
Ajay Patel
Thanks, Ram, for the question. Let me take the first half, and then I will let Mark answer the second part of your question. A guidance perspective, we do not typically give out kind of product-level guidance. But, obviously, as you think about our range and you have seen our fiscal 2025 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 Rovodan. It is just gonna be a reflection of, you know, 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 are 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 is generally how we are thinking about it. I think our long-term potential on, rolvidone, as we have indicated in the past, there is, you know, strong optimism that, capabilities of that product does have potential to reach, you know, exceed $100 million. We have looked at various ranges above that. You know, there are opportunities to reach $100 million to $130 million. And even beyond that. But, generally, we are 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.
Raghuram Selvaraju
Just very quickly, I wanted to get some quick clarity on one thing you said, AJ. Is it correct to assume that even the upper end of your guidance assumes some degree of degradation, erosion, in indocent sales relative to 2025. Is that a correct assumption?
Ajay Patel
That is a correct assumption.
Mark L. Reisenauer
Thank you.
Paul Schwichtenberg
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 I let me start first with the footprint, and then I will go to the subcategory. So the footprint we have in the community oncology space, which is actually, by the way, where most cancer patients are treated, is actually great place for any therapeutic, whether it is for liquid tumors or solid tumors. So I think that is 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 is the simplest way to think about it. Thank you.
Transcript from March 16, 2026

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