Assertio Holdings, Inc.

Gentlemen, thank you for standing by. My name is Abby and I'll be your conference operator today. At this time, I would like to welcome everyone to the Assertio Holdings third quarter 2025 results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's 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 one a second time. Thank you, 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 third 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's filings with the SEC. These and other risks are more fully described in the risk factor 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 Eisenhower, Chief Executive Officer.

Thank you, Daniel, and thank you to everyone for taking the time to join today. This is my first earnings call as CEO of Assertio, and I'm excited to be here today. I'm joined by Paul Schwichtenberg, our President and Chief Operating Officer, and A.J. Patel, our Chief Financial Officer. I'd like to give you some background on myself and touch on some high-level financial results from the quarter. Then Paul will talk about the roll-the-down pull-forward and AJ will go over the financial results in more detail. As you may know, I've served on the board for the past several months, bringing 30-plus years' experience commercializing and launching innovative products. Most recently at Astellas Pharmaceuticals, I led the commercializing of Blockbuster Therapies, Xtandi, and PADSEV. I also built and successfully scaled the Astellas Oncology franchise from scratch. That included enhancing market access and distribution capabilities, attracting and growing talent, and implementing successful product launches as well as growth and lifecycle management strategies. I'm thrilled to step into the CEO role and apply my experience here because I truly believe Assertio has the potential to generate significant value for patients and shareholders. The team has made a lot of progress and set the company up for a promising future with core growth assets like Rotodon and Simpazan and a solid balance sheet. Before I turn to our third quarter results, I want to take a moment to acknowledge the promotion of Paul Schwichtenberg to President and COO. Many of you know Paul from the numerous roles he's held during his time at Assertio, most recently as Chief Transformation Officer. Paul is a strategic and practical leader who has guided the company through several transformative initiatives. I look forward to working closely with him as we continue driving Assertio forward. Now onto this quarter's results. In the third quarter, we achieved financial results that position us to narrow our full year 2025 guidance. And we continue to support high quarterly unit demand for Rolvidon and maintained a leading market share position. As outlined in the release, Rovadon net product sales were $38.6 million for the third quarter of 2025, up from $15 million in the prior year quarter due to the pull forward of two quarters of Rovadon sales through the wholesale distribution channel. Rolvidon net product sales also drove adjusted EBITDA of 20.9 million for the third quarter of 2025, up from 4.4 million in the prior year quarter. The pull forward was done to ensure seamless availability to patients as we transition Rolvidon to our consolidated commercial labeler and we realign our corporate subsidiaries under a single operating entity. While this transaction will result in a temporary decrease in operating cash flow in the fourth quarter of this year and the first quarter of next year, we expect to maintain a leading market share and uninterrupted patient supply. Regular sales of the newly labeled Rolvidon will resume in the second quarter of 2026. Simplizan net product sales grew to 2.8 million for the third quarter of 2025, up from 2.6 million in the prior year quarter, driven by higher volume. We continue to strengthen our Simpazan oral film franchise with new data the team presented at the American Neurological Association meeting, which underscored the value the drug offers patients with difficulty swallowing. This quarter's results allow us to narrow our full year 2025 guidance. Our updated 2025 guidance reflects the impact of the roll-to-down pull-forward, and our greater visibility into the expected performance for the remainder of the year. This narrowing also reflects negative impacts from InDesign generic competition and decommercialization of Otrexa. I'll now pass the call over to Paul to introduce himself and provide more detail about the roll-to-down pull-forward. Paul?

Thanks, Mark. Over the last several years, I've had many roles at Assertio, including Chief Commercial Officer, Chief Financial Officer, and most recently, Chief Transformation Officer. So, I've had a front row seat to many of our recent initiatives, including the consolidation of our operations and driving continued growth for Rovadon. First off, reflecting on Rovadon's performance to date in 2025, we have seen 42% third quarter year-to-date demand growth versus the same period in 2024. We have been able to provide continued price stability and predictability for our customers over the last several quarters and achieved a 43% market share in the clinic Medicare Part B segment of the market in the third quarter. Third quarter Robodon sales reflect both normal demand and large purchases by several national distributors to help ensure consistent supply of Robodon over the next two quarters as we complete the integration of Robidon into Asserdio. This was done to ensure uninterrupted product availability to patients during the integration and allow sufficient time to manufacture the newly labeled products, establish Robidon with a new 3PL distributor, and execute on many other integration-related activities. Specifically, the volume sold in the third quarter of 2025 includes expected channel inventory sufficient to supply end customer demand for the fourth quarter of 2025 and the first quarter of 2026. No further sales of the spectrum-labeled Rovadon will occur, and the SERDIO specialty does not expect to record material product sales of Rovadon until the second quarter of 2026. From a customer and patient perspective, this will be a seamless transition. Also, related to Rolvidon, we executed a long-term supply agreement with HOMNI, our API manufacturer, in the third quarter, which positions us for continued stable supply and pricing going forward. Additionally, our same-day dosing data was presented at four oncology conferences since December of 2024, and most recently at the Network for Collaborative Oncology Development and Advancement Conference in October of this year, and we anticipate publication in a major journal in the near future. Looking ahead to 2026 and beyond, our goal is to maintain our strategy of price stability and predictability for our customers as we continue to pursue further demand and market share growth for Rolvita. With that, I'll now pass the call over to A.J., who will cover the financial results. A.J.? ?

Thanks, Paul. Today, I'll walk through our financial results for the third quarter of 2025. As a reminder, starting this year, we have resumed the use of year-over-year comparisons. Total product sales in the third quarter were $49.5 million, compared to $28.7 million in the prior year, primarily driven by the Rovodan two-quarter pull forward, as previously mentioned. As a result of this, we do not anticipate material Rovadon sales to wholesalers in the fourth quarter of 2025 and first quarter of 2026 and expect sales of the newly labeled Rovadon to begin in the second quarter of 2026. Simpazan sales were $2.8 million in the third quarter, up from $2.6 million in the prior year, driven by higher volume and partially offset by the impact of payer mix. Indicent sales were $4.8 million in the third quarter, down from $5.7 million in the prior year, reflecting expected impacts from previously announced generic competition. The higher proportion of Rovadon sales relative to our other products drove a modest decrease in overall gross margin to 72% compared to 74% in the prior year. Turning to operating expenses, reported SG&A expenses were $16.9 million, up slightly from $16.7 million in the prior year quarter, reflecting non-recurring costs related to the decommercialization of Otrexip partially offset by lower legal expense following the completion of related initiatives this year. Adjusted operating expenses, which exclude stock compensation, DNA, and other specified items, were $14.9 million compared to $17.3 million in the prior year, reflecting our efforts to streamline the business and drive cost efficiencies. Gap net income for the third quarter was $11.4 million, compared to a loss of $3 million in the prior year. And adjusted EBITDA for the third quarter was $20.9 million, up from $4.4 million in the prior year. Both driven primarily by higher Robodom sales. Turning to our balance sheet, as of September 30th, 2025, Cash, cash equivalents, and short-term investments totaled $93.4 million compared to $98.2 million at June 30th, 2025. The timing of cash collections and payments associated with the Rovadon sell-in is expected to result in a temporary decline in cash over the next two quarters before increasing in the second quarter of 2026. Total debt outstanding as of September 30th, 2025 remains unchanged at $40 million, comprised of the company's 6.5% convertible notes, with no maturities until September 2027. Lastly, as Mark mentioned, we are tightening our 2025 guidance within the range previously provided. We anticipate full-year product sales on the current operating portfolio to be between $110 and $112 million, and adjusted EBITDA to be between $14 and $16 million. Both the product sales and adjusted EBITDA guidance reflects the impacts of the pull forward of the Rovedon sales into the third quarter. With that, I will turn the call back to Mark.

Thank you, AJ. I'm pleased with the strong financial position we are currently in. As I continue in my new role, my focus is on advancing strategic initiatives that will drive growth. I will provide updates on those initiatives as they materialize. Abby, we're ready to take questions now.

Thank you. And we will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 a second time. 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 question and one follow-up. Again, it is star 1 if you would like to join the queue. And our first question comes from the line of Thomas Slayton with Lake Street. Your line is open.

Hey, good afternoon. Thanks for taking the questions, Paul. Congrats on the promotion. Nice to have you back on the calls. Let me start with you. Could you explain to us what, if any, linkage there is between labor code and ASP? Like, do you inherit the spectrum labeled ASP, or just walk us through the mechanics of that?

We don't really comment on forward-looking reimbursement for Robodon. So basically what I can tell you is that we expect to continue our strategy that I mentioned in my comments of price stability and predictability. So the labor code change is not tied to ASP. It's really about the integration of Robodon into Assertio.

Got it. And then there was a sequential uptick in Induson sales, which was a bit surprising. Any comments on what's kind of going on out there in the market for Induson?

Yeah, two things related to Induson. We've continued to maintain some good market share and volume in Induson despite the competition, and we've seen a little bit of price favorability as well quarter over quarter. So we're continuing to compete as best we can in the generic space.

Awesome. Appreciate you taking the question. Thank you.

Sure. And our next question comes from the line of Naz Rahman with Maxim Group. Your line is open.

Hi. Thanks for taking my question. First of all, I just want to say, nice to meet you, Paul. I don't believe we spoke before. But my question is geared mostly towards Mark. So, Mark, you obviously have a background in ecology, and Rovodaman obviously competes in that space. I understand you've only been in the COC for a few weeks now. But sort of based on everything you've seen and everything you know, do you have any thoughts on potentially optimizing Robidon's either promotional strategy or commercial strategy and also potentially adjusting the reimbursement strategy?

Yeah, thank you for the question. And what I would say, yes, it's a couple of weeks in, and currently reviewing with the team all of the current strategies. And so, as we come up with any refinements, we'll certainly let you know. But I think I'm certainly approaching this from the position of looking for any way that we can drive additional growth on our growth assets.

Thank you. And just one follow-up. It's just on the gross margins. So it looks like the gross margins so much stabilized this quarter. But with the rollback pulled through, what do you sort of expect to happen to gross margins going forward for the next two quarters? Or do you think it's kind of stabilized around here?

This is Adrian. I can take that. So obviously, we haven't given full guidance for next year yet. And we'll plan to do that at our March conference call. But I would say the targeted gross margin we had this year, which aligns with the guidance range we just gave, is in line with where kind of Q3 landed.

Got it. Thank you for taking my questions. Thank you.

And as a reminder, it is star one if you would like to ask a question. And our next question comes from the line of Ram Silvaraju with HC Wainwright. Your line is open.

Thanks so much for taking my questions. Firstly, a broad spectrum one for Mark. I was wondering if you could comment on the kind of differences in strategic priorities and core business objectives under the new direction as opposed to what historically was being prioritized, particularly with respect to business development. And then secondly, on a product front, I was just wondering if you could provide us with any color on emergent market trends that may be favorable towards Simpazan uptake and what you expect the generalized prospects for Simpazan sales acceleration in the coming quarters? Thank you.

Yes, thank you for your questions. I'll take the first one and I'll let Paul talk about the Simpazan question. So, regarding future strategy, what I am doing along with the management team and as well as with the board is currently reviewing and refining our strategies moving forward. When we have updates there, I will certainly provide that more broadly, but it's very early days in terms of that effort. Paul, you want to handle the Simpazan question?

Sure. As it stands right now, Simpazan is competing in a generic market. We're not seeing any significant changes to that market in the near future. but our differentiators, our delivery mechanism being the oral film. And what we're doing right now is we're focused on raising awareness of our product and getting the message out there. We've got reps in the field concentrated in high prescribing areas, and we're also trying to raise awareness for our digital promotion as well. So that's our focus right now for SimpSan.

Thank you. Thank you.

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