Hello, and welcome to the Assertio Holdings Second Quarter 2025 Results Conference Call. [Operator Instructions] I would now like to turn the conference over to Matt Kreps, Investor Relations. You may begin.

Thank you. Good afternoon, and thank you all for joining us today to discuss Assertio's second 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. With me today are Brendan O’Grady, our Chief Executive Officer; and Ajay Patel, our Chief Financial Officer. Brendan will open the remarks and provide an overview of the business, including an update on Assertio's long-term business strategy. After Brendan, Ajay 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 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 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 Brendan. Please go ahead. Brendan P. O’Grady: Thank you, Matt, and thank you to everyone who has joined today's call. I'll begin today with a brief overview of our second quarter financial results, which showcase both execution against the transformation phase priorities I have laid out as part of our long-term business strategy and our ability to focus the business in…

Thanks, Brendan. Today, I'll walk through our financial results for the second quarter 2025. As a reminder, starting last quarter, we have resumed the use of year-over-year comparisons reflecting completion of the stabilization phase that Brendan discussed for 2024. Q2 2025 product sales came in at $28.8 million compared to $30.7 million in the prior year quarter. Rolvedon sales were $16.1 million, up from $15.1 million in the prior year quarter, driven by higher volume and favorability from returns reserve adjustment partially offset by lower pricing. The returns reserve adjustment was $5.4 million and was previously established in connection with the Spectrum merger for specific channel inventory. Due to continued growth in demand and closure of the returns window, we no longer need to maintain the specific reserve. Sympazan sales were $3.2 million, up from $2.7 million in the prior year period, reflecting higher volume and favorable payer mix. Indocin sales were $3 million, down from $6.9 million in the prior year quarter due to the expected generic competition on volume and price. The prior year second quarter was still in the early stages of the generic impact. Turning to operating expenses. Reported SG&A expense was $17 million, down from $18.4 million in the prior year quarter, reflecting among other items, a onetime $2.4 million benefit from the recognition of employee retention tax credits. R&D expense was $0.4 million, down from $0.8 million a year ago due to the completion of the same-day dosing trial at the end of 2024. Excluding stock compensation, D&A and onetime items of ERC benefit, legal settlements and costs related to divestment of Assertio Therapeutics and decommercialization of Otrexup, adjusted operating expenses were $15.4 million in the second quarter versus $19.7 million a year ago, reflecting our efforts to drive operating cost efficiencies as well…

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

Just starting off, the -- so I'm trying to understand the kind of "true" Rolvedon sales in the quarter. I mean, if I take the number minus the reserve it's $10.7 million. Is that how we should be looking at it? I'm trying to -- can you help me better understand that? Brendan P. O’Grady: Yes, that's the correct number, Thomas.

So if I heard you correctly, Brendan, in the prepared remarks, it was the highest demand from providers. But then can you give us a sense of volume price shift there so we can kind of understand what's going on in demand versus pricing? Brendan P. O’Grady: Yes. I won't get into too much in pricing. That's something we don't really divulge, but I will just give you a little bit of a flavor, right? So there is ex factory sales that go into the wholesalers and then there's demand that goes from the wholesalers into the clinic. So as I mentioned, we had a rather high -- in fact, we grew demand by almost 20% from Q1 to Q2. So demand going into the clinics, which is ultimately -- which is what patients utilize is very strong. And we were a little lower on sales into the wholesalers, which sets us up really in a good position for strong execution in the second half of the year. So I wouldn't think about the year is taking $13.1 million and $10.4 million and then doubling it. I think we're in a very good position to achieve what we need to in the second half of the year with Rolvedon kind of balancing wholesaler and clinic demand.

Excellent. I appreciate that color. And then with respect to potential deals, can you give us a sense of what the market looks like today versus when you started? I mean, are there -- is there stuff you've passed on? Are there opportunities you've missed out on? Obviously, getting a deal in the door is 1 of your 5 priorities. Just trying to understand what the market looks like more broadly. Brendan P. O’Grady: Sure. No, the question. I wouldn't say we've missed out on anything. I mean there have been things that we've been somewhat interested in, but we look at how they fit into our model where we think the value is, and we're certainly willing to pay a fair market price. But if it exceeds that, and we can't really find a way that it makes financial sense, then we'll pass on it. So we've had a couple of opportunities like that, but we have numerous conversations ongoing for a whole wide variety of transactions. And so those go. I've been said all along. I want to be patient because I want to make sure we do the right transaction for the business. And as we are executing on Rolvedon and executing on everything else, we're actually strengthening the balance sheet. So that gives us a little bit wider of a fishing ground to look at. So good conversations ongoing. I said I'd like to get something done this year, we'll see where that goes.

And then 1 final one, if I may. When you guys laid out the $108 million to $123 million guidance, the big swing factor in there was the potential for a new generic entrant into the Indocin space. But now I guess the top has been reduced because of Otrexup. But do you -- given how far along we are into the year, do you think the swing is still going to be potentially $10 million primarily Indocin? Or what else is -- what would move that number, $10 million from bottom to top? Brendan P. O’Grady: Yes. Well, I will be in a much better position, Thomas, when we get to November to narrow this range considerably. There's other strategic things we're looking at that could impact that. It's not just Indocin, but there's other things that I really don't want to get into that could impact that range. But as I said, as we get through the third quarter here, and I come back in November, I'll be able to narrow that range significantly.

The next question comes from Ram Selvaraju with H.C. Wainwright.

Firstly, I just wanted to address the housekeeping item. In the wake of the divestiture to Assertio Therapeutics and the ATIH transaction, can you just review for us what remaining outstanding litigation matters there are under Assertio Holdings, or if at this juncture, there aren't any? Brendan P. O’Grady: So at this juncture, Ram, most of it is just some shareholder lawsuits that we're working our way through. Most of everything else has been closed out, and we've moved on. So as I said in my remarks, we hope to have that cleaned up and resolved by the end of this year or early next year, but made significant progress in reducing kind of our legal spend around defending different lawsuits.

Great. Secondly, I was wondering if you could just characterize some of the principal emergent drivers of Rolvedon pull-through demand, and how robust you expect those to be going forward, particularly not only as we go into the second half of 2025, but also looking ahead to 2026. Brendan P. O’Grady: Well, I think the biggest thing is expanding our customer base. We significantly expanded our customer base during first and second quarter, which is one of the reasons that you saw demand grow by almost 20%, and that isn't even a full quarter. So we expect demand to continue to grow, both in the clinic space where we primarily focus, but also we think that as we go through the second half of this year and especially into 2026, we'll see more commercial utilization, and we're working on securing that right now.

And then just 2 more very quick ones. Firstly, on Otrexup, can you remind us about the length of exclusivity that still remains for this product? And then also, if you could just characterize for us, now that Assertio has elected to halt commercialization activities on Otrexup, what does this effectively mean for the SG&A line, what does that translate into in terms of savings? What activities are no longer necessary? And also, how does that -- perhaps you're not in a position to comment on this now, but any helpful color would be appreciated. How does the absence of commercial activity for this product impact your ability to monetize it on a strategic basis going forward, assuming that your priority has now shifted from active commercialization to divestiture? Brendan P. O’Grady: Yes. So good questions, Ram. So I'll take part of it, and then I'll have Ajay take part of it. But if you think about Otrexup, I mean, we have -- we had 7 assets or we have 7 assets across a variety of therapeutic areas with Otrexup being primarily rheumatoid arteritis. So that's not really necessarily a core commercial focus on us -- for us. We made the decision to focus our commercial efforts around Rolvedon and Sympazan because those are the products that we see the most growth potential in. We had reached a point with Otrexup, where although it was driving top line, there was not much there as far as profit. So instead of spending additional funds to it, we decided to redirect those to where we thought we could actually grow. That doesn't mean that Otrexup couldn't be profitable in somebody else's hand. It might have a more complementary portfolio that they could add to their rheumatology basket of products. But Otrexup is methotrexate. There's no IP left on methotrexate in and of itself. It's combined in a pen from Halozyme, so it would be difficult to maybe duplicate the exact product because of the pen drug delivery combination but methotrexate itself has no IP. So there's other versions of it out there available in the market. Ajay, I'll let you talk about some of the cost savings.

Yes, Ram. We're expecting a good amount of cost savings from an SG&A perspective on Otrexup next year. It's in the range of $2 million to $3 million, which would comprise of any kind of direct spend we had on it from a digital marketing perspective and the annual PDUFA fee. Obviously, this is going to be offset by kind of the top line degradation. Overall, part of the decision was as we looked at the pricing competitive pressures that were there in top line and the cost pressures that are there from the device combo, it ended up being fairly neutral to EBITDA for this year -- for the remainder of the year. And that's why you actually see a benefit in our narrowing of the EBITDA range upwards on the low end.

The next question comes from Naz Rahman with Maxim Group.

Congrats on the progress. Just have a few. I just want to start on Rolvedon. I guess at this point, how much of an effect are you seeing from the same-day dosing data, if any? And I guess, more towards that point, when do you start -- when do you expect to see larger and greater effects from the same-day dosing data on sales? Brendan P. O’Grady: No, it's great. Good question, Naz. Thanks. We are starting to get increased levels of interest, and I think we've seen increased levels of interest in same-day dosing since we presented the results end of last year and then first quarter this year. So it's certainly an interest amongst providers. We know that it's a growing interest. We hope to -- we submitted to a peer-reviewed journal. We hope to have publication sometime this year. And I think once that, that happens, that will be another catalyst. And ultimately, the goal would be to get this into the NCCN guidelines, whether that materializes or not, we obviously don't control and when. But that really today is not built into any of our projections. So that would definitely be an upside. And as we move to publication, we'll take a look and see what kind of lift we're getting from that, but there's definitely interest in same-day dosing and the interest is increasing.

So I guess on that point, based on everything you now know in terms of publications and timelines, what are you thinking now in terms of timelines for getting the same-day dosing into NCCN guidelines? Brendan P. O’Grady: Well, I think the first step was publication. And as I mentioned, we hope to have publications still this calendar year. We've definitely made progress on that. And I would say NCCN probably by the middle of 2026, it's possible it could be earlier, but not probable.

Understood. And on Sympazan, now that you're accelerating efforts for promotion, based on what you've seen thus far, I guess, what sales levels do you think you could return or get Sympazan to at this point based on what you're seeing? Brendan P. O’Grady: Net sales number?

Yes. Net sales scripts, yes. Brendan P. O’Grady: Yes, I mean I think net sales could ultimately be between $25 million and $30 million in the next several years. So kind of double from where we are today. I think there's definitely growing awareness. And I think that Sympazan is benefiting just from a share of voice out there and providers recognizing that it's there, and how to prescribe it, and how patients can get it.

Got it. And just 1 last question. Can you -- How you're pulling resources and promotional efforts from Otrexup? Is there a potential to like divert some of that resources or I guess that time to Rolvedon and Sympazan? Like why don't you think those -- do you think those products could grow faster with Otrexup resources, or do you think there's not much of a difference there, I guess, logistically? Brendan P. O’Grady: No. I mean we are redirecting resources from other products to Sympazan and Rolvedon, but that's already built really into our projections. I mean this is -- Otrexup is not a decision that we made yesterday. We've been looking at Otrexup for quite some time, and it was built into this year's plan and projections other than the net sales piece, which we adjusted for.

This concludes the question-and-answer session and will conclude today's conference call. Thank you for joining. You may now disconnect.