Mallinckrodt PLC

Good day and thank you for standing by. Welcome to the Millicroup first quarter 2025 results 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 may be recorded. I would now like to hand the conference over to your speaker today, Gerard Muechner. Please go ahead.

Thank you, operator, and welcome, everyone. With me this morning are Mallin Cross CEO, Siggy Olofsson, and CFO, Brian Reasons. 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, and we assume no obligation to update them even in the event of new information or if actual results or future expectations change materially. We encourage you to refer to the cautionary statements contained in our SEC findings for a more in-depth explanation of the inherent limitations of such forward-looking statements. 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, which can be found on our website, mallincrot.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 our website for this information. This call does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or solicitation of any vote or approval. In connection with the potential combination between Mallinckrodt and Endo, Mallinckrodt has filed with the SEC a registration statement that includes a joint proxy statement of Mallinckrodt and Endo and a prospectus for Mallinckrodt shares. the joint proxy statement, prospectus, and other relevant documents filed by Mallinckrodt and Endo with the SEC will be available free of charge at the respective company's investor relations webpage or at the SEC's website. You should review such materials filed or to be filed with the SEC carefully because they contain or will contain important information about Endo, Mallinckrodt, the business combination, and related matters, including information about certain of their respective directors, executive officers, and other employees who may be deemed to be participants in the solicitation proxies in connection with the business combination and about their interest in the solicitation. As noted in our earnings release, our first quarter ended on March 28, 2025. Additionally, unless otherwise specified, the net sales percentage changes we discussed will be on a constant currency basis. I'll now turn the call over to Sigi.

Thanks, Gerard, and good morning, everyone. I'm pleased to report that Malincrot had a great start to the year, and we continued to build on our positive momentum from 2024. Our teams delivered another quarter of strong performance that kept us on track to achieve our full-year guidance, a sign of our confidence in the business. In the first quarter, we achieved a top-line growth when adjusting for the Theracos divestiture last year, demonstrating the meaningful progress we have made on our key strategic priorities. After gel sales grew for the fifth consecutive quarter, and the launch of our Celtic device has been tracking well ahead of our initial expectations as we continue to see a strong physician and patient demand. In light of this, we are increasing our marketing investments behind ACTA, which is reflected in our decision to reaffirm full-year guidance. In addition, our rollout of the INOMAX Evolve DS delivery system continued to hospital nationwide, and the ongoing efforts to expand adoption of Turlevas remains underway. On the specialty generic side, of the business, overall performance was strong, and we continue to see the benefits of the high-quality product and stable supply we offer customers. Our positive momentum also reinforces our excitement for the planned combination with ENTO that we announced in March. The merger will create a global scale diversified pharmaceutical leader, and we see even greater potential ahead for our business through the combination. I'll speak more on that shortly, but I want to highlight up front how proud I am of our teams for continuing to execute at a high level and deliver for our patients while doing the significant planning work to bring our two companies together. I turn now to the detailed update on our business sector. Starting with specialty brands and ACT-RGL, as I mentioned, we are pleased to deliver our fifth consecutive quarter of year-over-year growth with 12.3% increase in net sales in the first quarter. This was driven by growth in the overall market and the successful launch of Self-Gift, where the team has done a really outstanding work. Feedback from the healthcare providers and patients on Celljet has been overwhelmingly positive, and this innovative device now accounts for over 70% of all new ACT-R brand prescriptions, a number that is even higher for certain therapeutic areas and reflects the great momentum we have with both new and returning healthcare providers. We expect positive momentum in the self-debt rollout and patient demand growth to continue. As a result, we are raising our 2025 net sales guidance for ACTAR from a low single-digit range to a high single-digit range. Moving to INOMAX, our multi-year rollout of the evolved DS delivery system into U.S. hospital remains underway. As of the end of March, more than 400 devices were placed in over 50 hospitals nationwide, and we continue to benefit from customer interest in the portability and new features offered by the product, reflecting the importance of the system for the appropriate patients. As a reminder, we expect this rollout to continue throughout the end of next year, and we will be working closely with hospitals and providers to drive further adoption throughout this period and beyond. While INAMAX sales continue to be impacted by competition in the U.S. market, we were encouraged to see a stronger performance and growth outside of the U.S., particularly in Japan, where sales grew 12% as compared to the first quarter of 2024. Next, with Turlevas, we delivered a 23.3% net sales growth as compared to the first quarter of 2024. As a reminder, Turlevas is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. While hospitals demand growth has not been as strong as we would like, we continue to believe in the opportunities ahead for this treatment, as well as the meaningful benefit it can deliver to patients and their caregivers. Turning to specialty generics, we continue to build on our track record of consistent growth in the segment, delivering our ninth consecutive quarter of net sales growth. Strong performance in the ADHD finished product business was offset primarily by a global competitive pressure on the ATI business, particularly our APAP products. In a period of supply chain uncertainty, Malenkrot's generics business benefits from both leading product quality and consistency of supply, and we continue to expect a flat to low single digit sales growth for the segment in full year 2025. Before I hand it over to Brian, I'd like to give a brief update on our previously announced combination with Endo. Over the last month, we have spoken extensively with our stakeholders about the combination and are pleased with the positive feedback we have received to date. We remain confident in the bright future ahead of our companies as a one combined organization, which will benefit from increased scale to develop new therapies to address unmet patient needs. Our team has already hit the ground running in our work to complete the transaction, which we continue to expect will occur in the second half of 2025. In April, we filed our Form S4 registration statement with the SEC to begin the SEC process, a key milestone towards holding the shareholder meetings to consider and vote on the transaction. We have also formed a dedicated transaction planning team to support our integration efforts post-close. I look forward to sharing additional details in the coming months as we continue to work to bring our two companies together. With that, I'll turn the call over to Brian to discuss our financial performance and expectation for the balance of fiscal 2025 in more detail.