Mallinckrodt PLC

Good day and thank you for standing by. Welcome to the Kenova Q3 2025 earnings announcements conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Gerard Muechner. Please go ahead, sir.

Thank you, operator, and welcome, everyone. Before we begin, let me remind you that we will make forward-looking statements on this call, and it's possible that actual results could be materially different from our stated expectations. Please note these forward-looking statements are made as of today, November 10, 2025. and we assume no obligation to update them, even in the event of new information or if actual results or future expectations change materially, except as required by law. We encourage you to refer to the cautionary statements contained in our SEC filings for a more in-depth explanation of the inherent limitations of such forward-looking statements. Additionally, we note that this call does not constitute an offer to sell or the solicitation of an offer to buy any securities, and any such offering would be made pursuant to a registration statement to be filed with the SEC. We will also provide select non-GAAP adjusted measures related to our financial performance on this call. A reconciliation of these non-GAAP measures is included in our earnings release and in this presentation, which can be found on our website, chinova.com. We use our website as a channel to distribute important and time critical company information, and you should look to the investor relations page of the website for this information. As noted in our earnings release, the third quarter for Mallinckrodt ended on September 26, 2025. Mallinckrodt's third quarter earnings report includes combined business results since the completion of our merger with Endo on July 31, 2025. Joining me on today's call are Siggy Olofsson, our President and Chief Executive Officer, and Christiana Stamoulis, our President and Chief Financial Officer. Siggy and Christiana will provide an overview of our new company, Kinova Therapeutics, and review our performance for the third quarter in detail. I'll now turn the call over to Siggy.

Thanks, Gerard, and good morning, everyone. This year has been nothing short of transformative for us. First, we brought together two pharmaceutical leaders with the merger of Malincroft and Endo. Then, we combined our generics and sterile injectable businesses under the name ParHealth and announced today that we completed the spin-off of that business as a separate private company. This is an exciting day for our teams. And we are proud to introduce you to Keenova Therapeutics, a new company with a new identity and new future. Keenova strives to develop therapeutics that help patients with severe and unaddressed conditions live happier and healthier lives. The name Keenova evokes two complementary attributes of our company, the keen focus on helping patients receive the care they deserve and the innovation required to develop our therapeutics. Our new tagline, Keen to Solve, Keen to Serve, reflects our commitment to help solve the challenges our patients face and to serve them with integrity. Our diversified portfolio serves areas of significant unmet medical need. with focus on rheumatology, ophthalmology, nephrology, pulmonology, neurology, urology, orthopedics, and neonatal respiratory critical care. We have a strong platform in place with two key brands, Astagel and Thiaflex, a U.S.-focused footprint and strong commercial capabilities. Following the merger with Endo, We have a greater financial flexibility to build a robust pipeline by expanding the approved indications of existing assets and pursuing business development opportunities. The merger also created a meaningful opportunity opportunities. Kinova is on track on realized and benefit from approximately $75 million of pre-tax run rate synergies in the first 12 months post-merger and at least 150 million dollars of annual pre-tax run rate synergies by year three post-merger in the third quarter we were pleased to welcome new leadership to add to the existing strength of our executive team at such an important moment for the business that includes our president and chief financial officer Christiana Stamoulis, who has an exceptional record of achievement in strategy, finance, corporate development, and execution. She is with us on today's call and will review our financials shortly. Executive Vice President and Chief Scientific Officer Dr. Marek Honcharenko was another impressive addition to the team. Marek has a successful track record of launching name-brand products at some of the world's largest and most accomplished pharmaceutical companies, and his leadership will be key to building a more robust pipeline as well as a world-class R&D organization at Kinoa. Looking ahead, we currently intend to pursue a listing of Kinoa's ordinary shares on the New York Stock Exchange in 2026, subject to approval by Kinova's Board of Directors and other considerations and conditions. We expect to conduct a public offering of Kinova's ordinary shares to facilitate the listing at that time. In short, we have a strong foundation in place, and we are eager to keep building and delivering meaningful benefits for our patients, and value for our shareholders and partners. Our results for the third quarter reflect that Kinoa is off to a great start. While we operated as a combined business in the third quarter, we will focus our comments today on results related to the brand business, where we delivered a 10% top line growth on a pro forma basis versus the prior year quarter. Let's take a closer look at some key products and drivers from the portfolio. Starting with Aktergel, net sales in the third quarter increased 44% compared to the prior year quarter, making another quarter of significant growth. We are now in the second year of rolling out our self-guess device, and its strong ethic continues to play a pivotal role in ACT-RGL's growth. On the back of growing demand and broadening prescriber base and self-dip consistently exceeding expectation, we now expect ACT-RGL net sales growth of 30% to 35% for the full year. Next, Siaflex. Net sales growth in the third quarter was 2%, versus the prior year quarter, as we experienced certain unexpected shipment delays. We are also making important progress in our SiaFlex pipeline for new indications. I'm pleased to share that we have initiated a clinical program evaluating SiaFlex for hammer toe, and we have already recruited over 30 patients. We are also on track to complete patient enrollment in our Phase III clinical program, evaluating Siaflex for plantar fibromatosis by the end of the year, and we now expect top-line data to be available in the second quarter of 2026. Lastly, on INAMAX, we are pleased to see continued growth outside the U.S., with strong performance in Japan. We also continued to advance our multi-year rollout of the Evolve DS delivery system into U.S. hospitals. After the end of third quarter, we have more than 900 devices placed in over 100 hospitals nationwide. Our excellent execution this quarter position us to have a strong finish to the year. Before Christiana discusses the financial results in more detail, I would like to take a moment to acknowledge our teams. As I mentioned, this year has been transformative, and our employees have navigated many significant challenges, primarily the work of bringing together two companies and executing a spinoff. Their unwavering focus on advancing our strategic priorities and dedication to serving patients have put us in a position for continued success. Our people are why I have every confidence in a bright future for Kinova. Now, I'll turn the call over to Christiana.