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Assertio Holdings, Inc.
8/11/2025
After the speaker's remarks, there will be a question and answer session, and if you would like to ask a question at this time, please press star 1 on your telephone keypad. I would now like to turn the conference over to Matt Krepp, Investor Relations. You may begin.
Thank you. Good afternoon, and thank you all for joining us today to discuss Sardio'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 A.J. 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, A.J. will cover our financial results and guidance, Brenda 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 the CERTIOS 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 10Q filings. Our actual results may differ materially from those projected in the forward-looking statements. Sardio 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 Otrexit, 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 Rolvidon provider demand volume since launch, benefiting from an expanding provider base and continued growth in Simplizan 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 Rolvanon and Simpazan remains strong and is growing. We continue to execute diligently on our plans to drive further growth on each product. Indusyn and our other core non-core assets performed in line with expectations for net sales and contributions. 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 Rolvidon and Simpazan 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, simplify our corporate structure and processes, three, prioritize Asserdio's investment and growth assets, four, divest non-core assets where it makes sense, and five, Use 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 Ketam lawsuit, the last remaining GluMessa antitrust action, and Spectrum's legacy Luau 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 costs 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 Rolvidon. 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 Rolvidon demand while maintaining price stability and predictability for our customers during this change. Focusing on our progress prioritizing investments in Rolvidon and Simpazan, we've now finalized our third national agreement for Rolvidon 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 Rolvidan's long-term potential. I look forward to providing further updates at a later date. Regarding divesting non-core assets, as mentioned, we decided to stop commercializing Otrexip 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 into 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 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 increased 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, A.J. Patel, who will walk us through the details of our second quarter performance. A.J.?
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