Assertio Holdings, Inc.

I would now like to hand things over to Mr. Matt Kreps. Please go ahead, sir.

Thank you and good afternoon. Thank you all for joining us today to discuss the Sartius First Quarter 2025 financials. The news release covering our results for this period is now available on the investor page of our website at .sortiotx.com. I would encourage you to review the release and tables in conjunction with today's discussion. With me today are Brendan O'Grady, a Chief Executive Officer, and A.J. Patel, Chief Financial Officer. Brendan will open remarks and provide an overview of the business, including an update on Sartius' long-term business strategy. After Brendan, A.J. will cover our financial results and guidance. Brendan will then provide some closing comments before we take questions from our covering research analysts. 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 uncertainty, including those noted in today's, in this afternoon's press release, as well as Sartius' filings with the FCC. These and other risk factors 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. Sartius 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 Brendan. Please go ahead. Thank you, Matt, and thank you to everyone who has joined today's call. I'll begin today with a quick overview of our first quarter financial results, which are in line with the full year 2025 net product sales and adjusted EBITDA expectations that were set forth during the March earnings call. In the first quarter, net product sales came in slightly ahead of plan at 26 million, and we are tracking to our full year net product sales and adjusted EBITDA outlook. As I signaled in March, Rolvadon results in the first quarter were impacted by sell-through of fourth quarter initial stocking activity that supported customer and volume expansion, which we expect to benefit us from Q2 onward. In addition, we are continuing to add new customers and have strengthened our payer coverage that started in February with Cigna and expect to further expand our payer coverage going into the second half of this year. Overall, Rolvadon demand remains strong, and combined with our focused execution, we foresee net sales to continue increasing throughout the year. In addition, our revised Simpazan promotional strategy is proving effective with total Simpazan prescriptions in the first quarter up .5% year over year. This is a very positive trend that we expect will continue building in the quarters ahead. Lastly, Induscent remain stable in the first quarter, achieving our expectation for net sales and contribution. These results, along with expected performance throughout 2025, are influenced by the substantial progress Acerdio has achieved to date, implementing the long-term business strategy that I put into place last year. As I approach my one-year anniversary with Acerdio, I think it's important to recognize the team's progress and address our expectations moving forward. As previously stated, our strategy includes three phases characterized as stabilization, transformation, and growth. Stabilization was successfully completed in 2024, and has adapted our organization to the changing operating environment. We strengthened our balance sheet, repositioned our portfolio to focus on Rolvadon and Simpezan as core growth drivers, and rebalanced our talent and promotional resources. These significant achievements paved the way for us to begin implementing our current phase, transformation. This phase is occurring throughout 2025 as we implement actions intended to catalyze a shift in future growth potential. I will cover this in more detail in just a minute. Finally, the growth phase of our strategy is expected to start in 2026. During which time, we intend to become a leading commercially focused specialty pharma company that creates top tier value over the long term. Now, coming back to the transformation phase of our strategy, we set forth the following priorities for 2025. First, reduce legal exposure. Second, simplify our corporate structure and processes. Third, prioritize investment and growth assets. Fourth, divest non-core assets. And fifth, use the strength of our balance sheet to close a strategic transaction. These five transformation priorities are well underway with a goal of completing each by the end of this year. And I'm encouraged by our progress in just the first four months. I'll address several notable achievements and we'll start with reducing our legal exposure. Acerdio has settled multiple prior legal matters, including the previously disclosed 2017 Department of Justice False Claims Act QTAM lawsuit, the last remaining Glymetsa Antitrust action and Spectrum's Legacy Luao Securities Class action. It is important to note that we admit to no wrongdoing in any of these cases, but decided to settle rather than continue to litigate and incurring the cost of defend, as well as the distraction to our business. In addition, we obtained a dismissal of the company's Edwards Securities Class Action pending court approval. Our overall progress in reducing our legal exposure improves our ability to optimize operating expenses by reducing legal costs and refocusing those resources back to the business. As noted in our earnings release, we have also begun simplifying our corporate holding structure by transferring all of our assets in our Acerdio Therapeutics subsidiary to ATIH Industries LLC. At the closing of this transaction, Acerdio Therapeutics held approximately 8.2 million in cash, a single digit royalty in Anderson and certain legal liabilities, including those related to opioid litigation, which ATIH has assumed responsibility for managing and defending. As a result of this transaction, neither Acerdio Holdings nor any of its current subsidiaries remain named defendants in any opioid-related litigation. As we move throughout the year, we will also progress our strategy to divest some non-core assets, which will further improve our ability to reallocate corporate resources to focus on growth and bolster our balance sheet to acquire or unlicensed new growth assets. Already, we have added new marketing support for Rovedon and rebalanced promotional efforts for Simpozan by augmenting our omni-channel activities with select in-person support for the largest markets and key high-decel prescribers. As a result, we are seeing improved efficiency in sales performance, as previously mentioned. The actions I have just touched on allow Acerdio to optimize operating expenses so that we can better invest in the future and advance our strategic activities as we move through the transformation and into the growth phase. I want to conclude my remarks by stating that Acerdio's underlying business is strong and will be most successful by pivoting to a more sustained operating model driven by not only cashflow assets, but by growth assets. To be clear, our strategy is to focus on specialty pharma assets with the potential to grow over a sustained period of time within a commercially focused operating model. That is why we are implementing a long-term business strategy that we are confident can create sustained near-term growth and increase long-term value. I look forward to providing you with continued updates on our progress as we head through 2025. I will now hand over to our CFO, A.J. Patel, who will walk us through the details of our first quarter performance.

Thanks, Brendan. Today, I'll walk through our financial results for the first quarter of 2025. My commentary will resume the use of -over-year comparisons as we have now completed the stabilization phase that Brendan discussed regarding the 2023 spectrum acquisition and Indescent's generic competition, which made -over-year comparisons difficult in 2024. Q1 2025 product sales came in at $26 million compared to $31.9 million in the prior year quarter. Lovadon sales were $13.1 million, a decrease from $14.5 million in the prior year first quarter, driven by lower pricing, partially offset by higher volume. As Brendan mentioned, the current year first quarter was impacted by fourth quarter stocking. Indescent net product sales were $5.5 million, down from $8.7 million in the prior year quarter, due to the impacts of generic competition. The prior year first quarter was still in the early stages of the generic impact. Syntaxan sales were $2.2 million compared to $2.6 million in the prior year period, impacted slightly by pricing and volume. Reported gross margin increased to 70% from 65% a year ago. The prior year reported gross margin included Lovadon inventory step-up amortization. Excluding the impact of the inventory step-up, prior year gross margin was 78%. The year over year gross margin decline was driven by the impact of higher Lovadon volumes on cost of sales. Turning to operating expenses, reported SG&A expense was $22 million, up from $18.5 million in the prior year quarter, primarily driven by higher legal charges, including a net settlement charge of $2.8 million for the Lulau shareholder matter. R&D expense was $0.4 million, down from $0.7 million a year ago, due to the completion of the same day dosing trial at the end of 2024. Adjusted operating expenses, which excludes stock compensation, DNA, and non-recurring restructuring and legal settlement charges were $18.5 million compared to $17.3 million in the prior year period, due to higher external litigation costs. Gap net income for the first quarter was a loss of $13.5 million, compared to a loss of $4.5 million in the prior year. In addition to the impacts just discussed, gap net income was affected by higher intangible amortization expense, due to a change in useful life at the end of 2024. Adjusted EBITDA for the first quarter was $0.2 million, compared to $7.4 million in the prior year quarter, primarily reflecting the impact of lower net sales and gross margin as discussed. Turning to our balance sheet and cashflow statements, as of March 31st, 2025, cash and investments totaled $87.3 million, compared to $100.1 million as of December 31st, 2024. Cashflow from operations during the first quarter was impacted by the timing of approximately $12 million of accounts receivable collected in early April. At the end of April, 2025, cash and investments stood at approximately $96.7 million. Debt at March 31st, 2025 remains unchanged at $40 million, comprised of the company's .5% convertible notes with no maturities until September, 2027. With that, I will turn the call back to Brendan.

Thanks, AJ. In the first quarter, the ASSERDIO team delivered strong financial performance on track to the expectations that we set for 2025. We also demonstrated outstanding execution on the transformation phase of our business strategy with notable achievements that keep us on a path to realizing our goal of creating sustainable near-term growth and increased long-term value. I am confident that the strengths of our underlying financials, ongoing business performance, and business strategy will enable our success. With that, let's go ahead and open the call for questions from our analysts.

Thank you, sir. And everyone, if you would like to ask a question, please press star one on your telephone keypad. Our first question today comes from Thomas Slayton, Lake Street.

Hey, good afternoon, guys. Thanks for taking the questions. Brendan, congrats on offloading the opioid litigation matters. Just out of curiosity on that, was there value in either direction on that? Did you guys pay them to take it? Did they pay you to accept it? Was there any value movement there?

Yeah, just nominal value. They paid us,

Thomas. Okay. And a quick one for AJ. AJ, you guys have some relative to the beginning of last year. Your crude rebates, returns, and crude liabilities are up. How do we think about you guys using cash to bring those balances back down again? Will that occur pretty evenly over the course of the year, or how should we think about that?

Yeah, Thomas, thanks for the question. Yeah, I would think about that relatively evenly. As you know, the primary factor of that is RoleVidon with its ASP-based pricing. So as the rebates increase for that, the payments typically occur in the subsequent quarter.

Got it, understood. And just a final one for me, if I might. Any more thoughts on same-day dosing, progress with the NCCN, any update on that?

Yeah, Thomas. So as we've discussed or said before, it's kind of a 12-month strategy as far as the NCCN. So we've presented the results of the same-day dosing trial twice, once in December, once in, I think, March. We've approached a peer-reviewed journal for publication that we hope will be mid-summer. And once that's done, then we will approach NCCN about inclusion in the guidelines for 2026. So everything's moving according to plan. Ultimately, we don't control whether we get in the NCCN for the guidelines or not, but we are executing the plan to get there.

Excellent, I'll hop back into queue, thank you.

Sure.

We'll take the next question from Naz Rahman, Maxim Group.

Hi, thanks for taking my questions, and congrats on the progress. Just two questions. On RoleVidon, I believe you previously spoke about expanding into the hospital setting, a way for the community setting. Could you kind of provide some comments and details about how that's progressing thus far in 2025, and sort of where you start, or wherever you would expect to see an inflection point there?

Yeah, hi, Naz. Thanks for the question. I think if you think about RoleVidon, today most of our business is in the community oncology, Medicare Part B space. To be successful in the hospital space, we really need to grow our commercial payer side. That will unlock a couple of things for us. It'll unlock more of the commercial channel for us, and then it'll unlock hospitals as well. So the next step in the strategy is really to build our payer coverage, which we've done with Cigna, as I mentioned in my opening comments, and hope to expand in the second half of this year, and then further expand in 2026. As we do that, we'll be able to get more of the commercial clinic space business, as well as that'll enable us to impact or penetrate hospitals to a greater degree.

Got it, thank you. And my last question is just on guidance. So based on the adjusted EBITDA guidance of 10 to 19 million, why not adjust the band down, or do you still think it's possible, and what lovers do you think will get you to towards that 19 million? Why not suggest that band down from 10 to something else, due to the one-two results?

I think that there's still too many things going on that wouldn't make sense for us to adjust it down. We'll see how second quarter pans out, and we'll talk about it again in August. But at this point, I think the guidance ranges we've put out there for both EBITDA and Net Sales, I think we're tracking to within those guidance ranges, and we'll see how things go, but we'll update it again in August if necessary. All right, thanks for taking my questions.

Sure. The next question will come from Ram Silveraju, HC, Wayne Wright.

Thanks very much for taking my questions. Just in furtherance of additional context regarding the Rovodon situation, can you give us a sense of what additional promotional or marketing strategies you expect to implement over the course of the remainder of this year to try to accelerate growth and Rovodon sales?

Sure. Hi, Ram, thanks for the question. A couple things. I mean, first of all, there's still more market share we can get in our primary space, which is the Medicare Part B clinics. There's still some large groups out there that we hope to attract additional volume with and additional shares, so that's one. Second, I mentioned the payer piece. We've just begun to start starting to pull that business through on the commercial side, so that's two. We hope to expand that coverage in the second half of the year, which would be the third, and again, that will enable us to get some penetrations in the hospital. So if you see that is kind of building throughout the year, we expect Rovodon to continue to grow in net sales and volume as we go through this year.

Can you talk about how you expect the overall genericization picture to evolve over the course of the remainder of 2025 with respect to Indusen? Are you expecting a substantial additional number of generic purveyors of Indusen between now and the end of 2025, so approximately how many and what impact do you expect that to have, even if only on a qualitative basis regarding the remaining Indusen revenue streams?

Yeah, another good question, thanks, Ram. I think our plan assumed two more generics for Indusen this year, one in the first half of the year, one in the second half of the year. There was an approval back in February. We have not got any confirmation of launch yet, so I think we're still relatively tracking to plan, but you can think about if there's three on the market, you split the market by three. If there's four on the market, you split it by four. So each time you lose volume and you lose price, so it will decline with the entrance of more generics. But I think I'm optimistic right now that we're tracking to our plan. I think we've got a pretty good handle on it. We'll optimize Indusen as much as we can as we go through the year.

And then lastly, you had mentioned on this in a couple of previous calls, the interest of the company in doing something on the strategic front to broaden potentially the commercial portfolio. Can you give us some additional context on that, if there's been any sort of evolution in your thinking, particularly if this pertains to the broader market environment, changes that you're seeing within that, and also the possibility of identifying opportunities that are directly synergistic with your existing commercial assets?

Yeah, I mean, we have numerous ongoing conversations, all very positive conversations going in the right direction. And I'm very optimistic that we will get something done in 2025 that will certainly add to our business and position us for that growth phase in 2026. I obviously can't be more specific than that, but I'm very encouraged by the conversation that we currently have going on.

But just for clarification purposes, as of right now, your forecast or outlook for 2025 is not contingent upon any such business development activity being successfully concluded, is that correct?

That is correct. Our outlook for 2025 includes only our current portfolio.

Thank

you. Yep.

Our next question today comes from Scott Henry, Alliance Global Partners.

Thank you, and good afternoon. I guess first, with regard to RoleVidon, you do mention pricing pressure. Could you talk about the pricing, how it is kind of year over year and sequentially, and your expectations going forward?

Yeah, hi, Scott. It is a quarter to quarter type of strategy. So, ASP does erode over time and some quarters is a bigger impact than others. It's a very competitive marketplace as we play in this new, last bio-similar long-acting GCSF space. And there could be new entrants that enter as we go through this year, that could also have an impact. So, I think we're doing a very good job of maintaining and managing our ASP. I think the way that we think about the business and the way we execute and contract the business is smart, which I think is why our ASP has been slower to erode maybe than others. And we continue to build volume and gain new customers. And that's part of the step down from Q4 to Q1 was, we brought in some new customers in Q4 that we're going to pull through in Q1. So, we wanted that inventory there and we pulled that through in Q1. So, you'll start to see that grow as we go into Q2 and beyond.

Okay, thank you for that color. And then with regards to ST&A, I believe you said that the base ST&A is around $18.5 million quarterly. I guess the question is, did I hear that correct? And as well, what would you expect for the legal wind down, particularly given that you've had this divestment, should that start to be declined materially in the coming quarters or how long should some of that other litigation take?

Yeah, no, thanks for the question, Scott. You're right. So, the base adjusted outbacks for the first quarter was 18.5 million. Now in the first quarter, we were burdened. We typically have two components of litigation exposure, legacy matters and shareholder matters. As Brendan kind of alluded to in his comments, the legacy matters for the most part have been mitigated now with the divestment of a serial therapeutics. We are expecting kind of on an annualized front that to benefit us in the neighborhood of two to $3 million annually. And then from a shareholder litigation, as we continue to resolve, settle and exit those cases, the ongoing burden does decrease over time.

Okay, thank you. Final question, just for clarity, what assets exactly did you divest into the AITH entity? And was there any material, even dot impact from those assets?

There is just a single digit royalty on indecisive that we divested with the therapeutics divester in ATIH, as well as some cash.

Okay, all right. So none of the other products went with it, none of the smaller

ones? Nope, nope.

Okay, and if I may, and I guess I don't wanna ask you a legal question, but I think I'm going to. If you divest some of your legal responsibilities to this asset, what is the risk that they could still come after the parent company that you can't in fact completely divest that liability?

Well, I mean, if you think about it, the way that we got the liability was through M&A. And so this is no different. We transferred this legal entity to a third party that is going to maintain and run this business and manage it accordingly. So while there's always a risk, I think the risk is very, very low.

And everyone, just a reminder that it is star one if you have a question. Up next is Jim Sidoti, Sidoti and Company.

Hi, good afternoon. Thanks for taking the questions. In addition to all the internal changes there, you're dealing with some external changes as well. Can you comment on what impact you think there could be from either the tariffs or the executive order regarding drug pricing or the proposed changes to Medicaid?

Yeah, I mean, so the tariffs is who knows, right? That's a daily up and down. We've got a significant, I mean, probably a thing we would be most exposed on with tariffs would be drug substance on Rovedon, but we've got a significant inventory here in the US. So we don't expect any short-term impact. And by the time there is an impact, hopefully that situation will be worked out. With regard to drug pricing, we do not sell any products outside of the US with the exception of Cambia that we sell in Canada. And Cambia is probably more expensive than Canada. The fact that it's not generic and it's generic here. So, we'll see, there needs to be a lot more details on drug pricing. It's gonna take a while for the details to come out as to how that's actually gonna play out. But at least right now, we don't see any real risk on either one of those two things.

Okay, and I just wanna be clear post the divestiture, are you maintaining your revenue guidance from 100 in May to 122 million?

We are. Okay, thank you.

Yep. And at this time, there are no further questions. Everyone that does conclude today's ASSERDIO Holdings first quarter conference, we would like to thank you all for your participation. You may now disconnect.