Assertio Holdings, Inc. Q2 FY2025 Earnings Call

Hello, and welcome to the Assertio Holdings Second Quarter 2025 Results Conference Call. 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.

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 ways that improve operating performance for our investors. We have also updated our full-year outlook accordingly, slightly reducing the top end of our revenue range to account for our decision to stop commercialization of Otrexup, but more importantly, raising the lower end of our adjusted EBITDA outlook as this action has a positive impact in increasing profitability. To get a little further into the details, second quarter net product sales came in on plan at $28.8 million. These sales results reflect the highest Rolvedon provider demand volume since launch benefiting from an expanding provider base and continued growth in Sympazan prescriptions from both existing and an increasing number of new prescribers. This is in response to our decision last year to augment our omnichannel marketing with in-person sales in key markets. Overall, demand for both Rolvedon and Sympazan remains strong and is growing. We continue to execute diligently on our plans to drive further growth on each product. Indocin and our other core noncore assets performed in line with expectations for net sales and contribution. These results underpin the three-part business strategy I introduced during our year-end call in March and further detailed during the May earnings call. To briefly recap, the three phases are defined as stabilization, transformation, and growth, and are intended to create substantial near-term growth and increasing long-term value. Stabilization was successfully completed in 2024 and has adapted our organization to the changing operating environment and reprioritization of assets. That stage included repositioning our portfolio to focus on Rolvedon and Sympazan as core growth drivers, leading to the benefits seen on both of these products year-to-date with an expectation of more to come. I have characterized 2025 as the transformation phase, focusing on actions intended to catalyze a shift in future growth potential, and that's obviously where we are today. Continued successful execution of our transformation objectives will launch the growth phase of our strategy 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 I'd like to provide you with a brief update on our transformation progress. In the second quarter, we advanced each of our five core objectives and expect all to be complete or nearly complete by the end of the year. As a reminder, these include: one, reducing our legal exposure; two, simplifying our corporate structure and processes; three, prioritizing Assertio's investment in growth assets; four, divesting noncore assets where it makes sense; and five, using the strength of our balance sheet to close a strategic transaction. Starting with reducing our legal exposure, we have now settled or closed multiple prior legal matters helping to remove both ongoing operating costs and future uncertainty from the business. Resolutions to date include the 2017 qui tam lawsuit, the last remaining Glumetza antitrust action, and Spectrum's legacy Luo security class action pending court approval. We have not admitted to any wrongdoing in any of these cases; rather, the decision to settle reduces both ongoing legal costs and distraction from our core business. We also obtained a dismissal of the company's Edwards security class action suit. With these matters now closed, we can refocus funds previously allocated to legal costs into building our core business. We also began simplifying our corporate holding structure to reduce cost and complexity in our business. One of the key actions completed in the second quarter was the transfer of all our interest in our subsidiary Assertio Therapeutics to a third-party ATIH Industries LLC. As of today, Assertio Holdings nor any of its subsidiaries are named defendants in any opioid-related litigation. Also, as part of our corporate restructure, we are consolidating products from previously acquired operating subsidiaries to further consolidate our commercial footprint and further reduce operating expense. As part of this process, we have initiated a labeler code change for Rolvedon. This may result in net sales fluctuations over the next three quarters due to certain timing aspects but we expect 2025 company net sales to be within our guidance range. Further, we expect to fully support Rolvedon demand while maintaining price stability and predictability for our customers during this change. Focusing on our progress prioritizing investments in Rolvedon and Sympazan, we've now finalized our third national agreement for Rolvedon with the GPO of a leading national payer. This milestone reflects continued momentum in our market access strategy. We are currently working with the GPO to engage their national member organizations in discussions to broaden commercial formulary positioning for our product. We believe this agreement represents a meaningful opportunity to broaden access and support long-term growth for one of our two core growth assets. In addition, we're seeing sustained momentum across strategic market segments as organizations explore forward-looking approaches to care delivery. This latest agreement further substantiates a growing trend of engagement, underscoring our conviction in Rolvedon's long-term potential. I look forward to providing further updates at a later date. Regarding divesting noncore assets, as mentioned, we decided to stop commercializing Otrexup and are exploring various options for this product going forward. This is intended to free up additional resources to reallocate to our growth assets, bolster our ability to acquire or in-license new growth assets, and increase our profitability. We are looking at the balance of our portfolio with a similar focus on improving cost efficiency and sales performance. These actions are driven by strategic decisions to thoughtfully address near-term costs and disruptions for the benefit of our long-term business performance. This quarter's progress and our updated outlook demonstrate a sharpened focus to create greater efficiency, redirect resources, and ultimately improve profitability as we move through the transformation and to the growth phase. We believe that Assertio has reached an inflection point and will be most successful by pivoting to a focus on specialty pharma assets with the potential to grow over a sustained period with a commercially focused operating model. And that is where our fifth transformation priority is focused, expanding and diversifying our portfolio with new growth assets, whether acquired, licensed, or via some other form of transaction. We remain active in that area but are also focused on securing the right transaction at the right price, which our balance sheet improvement continues to support with greater flexibility. I'll conclude my remarks today, building on what I said last quarter. Assertio's underlying business is sound. We have an experienced team that is executing very well, and our balance sheet fueled by more than $98 million in cash and investments at the end of the second quarter is solid. I am confident that our long-term business strategy is leading us in the right direction toward our goal of creating sustainable near-term growth and increase long-term value. I look forward to providing you with additional updates on our progress as we head through the second half of this year. I will now hand it over to our CFO, Ajay Patel, who will walk us through the details of our second quarter performance.

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 one-time $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 one-time items of ERC benefit, legal settlements, and costs related to divestment of Assertio Therapeutics and de-commercialization 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 as timing of certain annual spend. GAAP net income for the second quarter was a loss of $16.4 million compared to a loss of $3.7 million in the prior year. The change in net loss reflects one-time charges including $9.2 million related to the divestiture of Assertio Therapeutics and $3.8 million pertaining to the decision to cease Otrexup commercialization, which were partially offset by a $2.4 million benefit from the recognition of employee retention tax credits. Adjusted EBITDA for the second quarter was $5.6 million compared to $3.1 million in the prior year quarter. Turning to our balance sheet and cash flow statements. As of June 30, 2025, cash, cash equivalents, and short-term investments totaled $98.2 million, an increase from $87.3 million as of March 31, 2025. The increase was driven by positive operating cash flows as a result of overall performance and favorable working capital, partially offset by investing activity of $8.2 million transferred in connection with the divestment of Assertio Therapeutics. Debt remains unchanged at $40 million, comprised of the company's 6.5% convertible notes with no maturities until September 2027. As Brendan mentioned, we are narrowing our guidance ranges for net product sales and adjusted EBITDA to reflect first half performance, the decision to cease commercialization of Otrexup, and improved operational efficiencies. The revised annual guidance range has been updated for net product sales to $108 million to $118 million and for adjusted EBITDA from $11 million to $19 million. I'll now hand the call back to Brendan.

Thank you, Ajay. The Assertio team delivered a second quarter of strong financial performance and remains on track to meet our expectations for 2025. We also demonstrated the potential value of our transformation initiatives in creating both short-term and long-term value for our stockholders. We remain fully focused on executing the remaining transformation initiatives planned for this year, and I am confident that our ongoing business performance and execution of our business strategy will enable our success. And with that, let's go ahead and open the call for questions from our analysts.

Your first question comes from Thomas Flaten with Lake Street.

I’m looking to clarify the actual Rolvedon sales for the quarter. If I subtract the reserve, the figure is $10.7 million. Is this the correct way to interpret it? Can you help me understand this better?

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?

Yes. I won't go into too much detail about pricing since it's not something we reveal, but I can provide some insight. There are sales from the factory to wholesalers, and then there's the demand that flows from wholesalers to clinics. We experienced significant growth, with demand increasing by nearly 20% from the first quarter to the second quarter. The demand going into clinics, which is what patients ultimately depend on, is very strong. We did see slightly lower sales into wholesalers, which puts us in a favorable position for strong performance in the latter half of the year. Therefore, I wouldn't consider the year just a simple doubling of $13.1 million and $10.4 million. We are in a great place to meet our goals in the second half of the year with Rolvedon balancing the demand between wholesalers and clinics.

I appreciate that information. Can you provide an update on the current market compared to when you started? Have there been deals you've declined or opportunities that slipped by? Securing a deal is one of your top five priorities, so I want to understand the broader market landscape.

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.

When you provided the guidance of $108 million to $123 million, the main variable was the possibility of a new generic competitor entering the Indocin market. However, it seems the upper range has been lowered due to Otrexup. Considering how far we are into the year, do you believe the potential variation will still be around $10 million primarily related to Indocin? What other factors could influence that $10 million difference between the lower and upper estimates?

Yes. Well, I will be in a much better position, Thomas, when we get to November to narrow this range considerably. There are other strategic things we're looking at that could impact that. It's not just Indocin, but there are 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?

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.

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.

Can you remind us about the length of exclusivity that still remains for Otrexup? Additionally, since Assertio has decided to halt commercialization activities for Otrexup, what does this mean for the SG&A line and what kind of savings can we expect? What activities will no longer be necessary? Also, how might the lack of commercial activity for this product affect your ability to monetize it strategically going forward, especially now that your focus has shifted from active commercialization to divestiture?

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 had seven assets or we have seven assets across a variety of therapeutic areas with Otrexup being primarily rheumatoid arthritis. So that's not really necessarily a core commercial focus 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 the top line, there was not much there as far as profit. So instead of spending additional funds on 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 are 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 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 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.

Congratulations on the progress. I have a couple of questions. First, can you provide insights on Rolvedon? Specifically, what impact are you observing from the same-day dosing data, if any? Also, when do you anticipate seeing a more significant impact from this data on sales?

No, it's great. Good question, Naz. Thanks. We are starting to see increased levels of interest, particularly in same-day dosing, since we presented the results at the end of last year and in the first quarter of this year. There is definitely growing interest among providers. We have submitted to a peer-reviewed journal and hope to have a publication sometime this year, which could act as another catalyst. Ultimately, our goal is to get this into the NCCN guidelines, but we cannot control if or when that will happen. Currently, this is not included in any of our projections, so it would represent an upside. As we approach publication, we will assess the potential impact we might see from that, but there is clearly an increasing interest in same-day dosing.

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?

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?

Net sales number?

Yes. Net sales scripts, yes.

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 one last question. How are you reallocating resources and promotional efforts from Otrexup? Is there a possibility to shift some of those resources or time to Rolvedon and Sympazan? Do you believe those products could grow faster with Otrexup's resources, or do you think there isn't much difference in that regard logistically?

We are reallocating resources from other products to focus on Sympazan and Rolvedon, and this adjustment is already factored into our projections. The decision regarding Otrexup was not made recently; we have been evaluating it for a considerable period, and it has been included in this year's plans and projections apart from the net sales adjustment we made.

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