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Assertio Holdings, Inc.
11/10/2025
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. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one a second time. Thank you, and I would now like to turn the conference over to Daniel Santos with Longacre Square Partners. You may begin.
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 Assertio's 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 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 Eisenhower, Chief Executive Officer.
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 roll-the-down pull-forward and AJ 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 PADSEV. 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 lifecycle 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 Rotodon and Simpazan 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 Rolvidon and maintained a leading market share position. As outlined in the release, Rovadon 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 two quarters of Rovadon sales through the wholesale distribution channel. Rolvidon 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 Rolvidon 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 Rolvidon will resume in the second quarter of 2026. Simplizan 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 continue to strengthen our Simpazan 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 roll-to-down pull-forward, and our greater visibility into the expected performance for the remainder of the year. This narrowing also reflects negative impacts from InDesign generic competition and decommercialization of Otrexa. I'll now pass the call over to Paul to introduce himself and provide more detail about the roll-to-down pull-forward. Paul?
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