Assertio Holdings, Inc. (NASDAQ:ASRT) Q3 2025 Earnings Call Transcript

Assertio Holdings, Inc. (NASDAQ:ASRT) Q3 2025 Earnings Call Transcript November 10, 2025

Assertio Holdings, Inc. beats earnings expectations. Reported EPS is $0.1075, expectations were $-0.08.

Operator: Ladies and 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. [Operator Instructions]. And 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’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 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.

Mark L. Reisenauer: 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 Rolvedon pull-forward, and A.J. 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 PADCEV.

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 life cycle 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 Rolvedon and Sympazan 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 Rolvedon and maintained a leading market share position. As outlined in the release, Rolvedon 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 2 quarters of Rolvedon sales through the wholesale distribution channel.

Rolvedon 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 Rolvedon 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 Rolvedon will resume in the second quarter of 2026. Sympazan 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 continued to strengthen our Sympazan 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 Rolvedon pull-forward and our greater visibility into the expected performance for the remainder of the year. This narrowing also reflects negative impacts from Indocin generic competition and decommercialization of Otrexup. I’ll now pass the call over to Paul to introduce himself and provide more detail about the Rolvedon pull forward. Paul?

Paul Schwichtenberg: 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 Rolvedon. First off, reflecting on Rolvedon’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 Rolvedon sales reflect both normal demand and large purchases by several national distributors to help ensure consistent supply of Rolvedon over the next 2 quarters as we complete the integration of Rolvedon into Assertio. This was done to ensure uninterrupted product availability to patients during the integration and allow sufficient time to manufacture the newly labeled product, establish Rolvedon with a new 3PL distributor and execute on many other integration-related activities. Specifically, the volumes 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 Rolvedon will occur and the Assertio Specialty does not expect to record material product sales of Rolvedon until the second quarter of 2026.

From a customer and patient perspective, this will be a seamless transition. Also related to Rolvedon, we executed a long-term supply agreement with Hanmi, 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 4 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 Rolvedon.

With that, I’ll now pass the call over to A.J., who will cover the financial results. A.J.?

Ajay Patel: 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 Rolvedon 2-quarter pull-forward, as previously mentioned. As a result of this, we do not anticipate material Rolvedon sales to wholesalers in the fourth quarter of 2025 and first quarter of 2026 and expect sales of the newly labeled Rolvedon to begin in the second quarter of 2026. Sympazan 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.

Indocin 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 Rolvedon 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 nonrecurring costs related to the decommercialization of Otrexup, partially offset by lower legal expense following the completion of related initiatives this year. Adjusted operating expenses which excludes stock compensation, D&A 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.

GAAP 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 Rolvedon sales. Turning to our balance sheet. As of September 30, 2025, cash, cash equivalents and short-term investments totaled $93.4 million compared to $98.2 million at June 30, 2025. The timing of cash collections and payments associated with the Rolvedon sell-in is expected to result in a temporary decline in cash over the next 2 quarters before increasing in the second quarter of 2026. Total debt outstanding as of September 30, 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 between $110 million and $112 million and adjusted EBITDA to be between $14 million and $16 million. Both the product sales and adjusted EBITDA guidance reflects the impacts of the pull-forward of the Rolvedon sales into the third quarter. With that, I will turn the call back to Mark.

Mark L. Reisenauer: Thank you, A.J. 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.

Q&A Session

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

Thomas Flaten: Paul, congrats on the promotion. Nice to have you back on the call. 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 could you just walk us through the mechanics of that?

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

Thomas Flaten: And then there was a sequential uptick in Indocin sales, which was a bit surprising. Any comments on what’s kind of going on out there in the market for industry?

Paul Schwichtenberg: Yes. Two things related to Anderson. We’ve continued to maintain some good market share and volume in Indocin 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.

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

Nazibur Rahman: First of all, I just want to say nice to meet you Paul. I don’t believe we you spoke before. But my question is geared mostly towards Mark. So Mark, you obviously have a background in oncology and Rolvedon obviously competes in that space. I understand you’ve only been at 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 Rolvedon’s either promotional strategy or commercial strategy and also potentially adjusting the reimbursement strategy?

Mark L. Reisenauer: Yes. 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.

Nazibur Rahman: And just one follow-up is just on the gross margins. So it looks like the gross margins somewhat stabilized this quarter. But with the Rolvedon pull-through, what do you sort of expect to happen to gross margins going forward for the next 2 quarters? Or do you think you just kind of stabilize around here?

Ajay Patel: This is A.J. 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.

Operator: [Operator Instructions] And our next question comes from the line of Ram Selvaraju with H.C. Wainwright.

Raghuram Selvaraju: 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 emerging market trends that may be favorable towards Sympazan uptake and what you expect the generalized prospects for Sympazan sales acceleration in the coming quarters?

Mark L. Reisenauer: Yes. Thank you for your questions. I’ll take the first one, and I’ll let Paul talk about the Sympazan question. So regarding future strategy, what I am doing, along with the management team 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, do you want to handle the Sympazan question?

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

Operator: 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.