Mallinckrodt PLC

Ladies and gentlemen, thank you for standing by and welcome to Mel and Claude's second quarter 2025 results conference call. At this time, all lines are in a lesson only mode. Following the presentation, we will conduct a question and answer session. If anyone has any difficulties hearing the conference, please press door zero for operator assistance at any time. Please note, this event is being recorded I will now turn the call over to Gerard Muechner to cover forward-looking statements. Please go ahead.

Gerard Muechner Thank you 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, and we assume no obligation to update them. even in the event of new information or 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. We will also provide select non-GAAP adjusted measures related to our financial performance on this call. Reconciliation of these is included in our earnings release, which can be found on our website, mnk-endo.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 mnk-endo.com for this information. As noted in our earnings release, the second quarter for Legacy Mallinckrodt ended on June 27, 2025. And the second quarter for Legacy Endo ended on June 30, 2025. Additionally, unless otherwise specified for Legacy Mallinckrodt results, 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. Just last week, we completed the merger of Mallinckrodt and Endo. And we are very excited to be speaking with you for the first time as a combined company. Today, we will cover the financial results of each legacy business for the second quarter of 2025, which ended a few weeks before completion of the merger. I'm joined by the legacy CFOs of each business, Brian Reasons for Malincroft and Mark Bradley for Endo. They will walk you through the numbers and performance highlights from both standalone companies, and then I'll share our outlook for the combined company. Before we dive into the numbers, I'd like to start with an update on two subjects. Our merger and announcement this morning of our new president and CFO, Christiana Stamolis, as we announced this morning. As I mentioned, We were very pleased to announce the successful completion of a combination of malacrotin and endo on July 31st. When we first announced the merger in March, we saw an extraordinary opportunity to combine two highly complementary pharmaceutical organizations, and our excitement about what malacrotin and endo can accomplish together has only grown since then. Over the past few months, we have had a team dedicated to developing a comprehensive integration plan and preparing for our future as one organization. Through these efforts, we have seen how well our teams work together and how closely our cultures align, and we are starting this new chapter ready to hit the ground running. I'd like to thank the employees and leaders from both companies for their extraordinary efforts. We are now focused on executing on our vision for the future of our combined company. And in that regard, I'm excited to announce that we have recruited Christiana Stamolis as our new president and CFO. Building a new organization requires not only bringing together the existing talent of both companies, but also bringing in a new talent with experiences and ideas different from our own. In that regard, we are really excited to have Christiana on board. She is an exceptional talent with deep experience in biotech, finance, and strategy, and we are looking forward to the contributions she will make to supporting our new future. The new Mallinckrodt combines two organizations with rich legacies of innovation committed to accelerating the value creation we can deliver to our stakeholders. Our specialty brands portfolio spans a wide range of therapeutic areas of significant unmet need, and with durable on-market products, we are well positioned for growth. We also have a strong balance sheet and meaningful financial flexibility to invest in innovation and business development. Our combined generics and sterile injectables business, which operates under the ParHealth name, features a broad product portfolio and leading controlled substances franchise and testing class capabilities across the value chain. With financing secured for the merger, And I should acknowledge the effort of our financing bankers led by , we are all well-positioned to move forward with our plan spin-off in the fourth quarter of 2025, subject to our board's approval and all the conditions. We are moving forward with urgency and energy to unlock our full potential as a larger and more diversified company. And while we are in early days of executing our integration plans, we remain on track to achieve our synergy targets of generating at least $150 million of annual pre-tax run rate operating synergies by year three, and approximately $75 million of pre-tax run rate synergies in the first 12 months post-merger. Before turning the over the call, I want to emphasize that the strong financial results we are sharing today only reinforce my confidence in this combination and what we can achieve as one organization. On that note, I'll flip the call over to Mark, who will discuss Legacy Endo's financial results for the second quarter.

Thank you, Figge, on behalf of the entire Endo team. I echo your remarks about our combination and how excited we are to move forward as one company. Turning to Endo's second quarter 2025 results, we are pleased to share that the company performed in line with Endo's expectations for the quarter, which reflected a meaningful sequential increase from the first quarter of 2025. Second quarter 2025 total revenues were $448 million flat compared to $446 million in the second quarter of 2024. However, Excluding the international segment, which was divested in the second quarter, total revenues increased by approximately 2% in the second quarter of 2025 compared to the second quarter of 2024. Second quarter 2025 adjusted EBITDA was $150 million compared to $176 million in the second quarter of 2024. This change was primarily driven by lower adjusted growth margin due to changes in product mix and continued investments in the sterile injectables manufacturing network. Second quarter 2025 adjusted net income was $64 million compared to $105 million in the second quarter of 2024. This change was primarily due to the decrease in adjusted EBITDA previously mentioned, coupled with an increase in interest expense. Turning to segment level performance, the brand pharmaceutical segment reported revenues of $228 million in the second quarter of 2025, compared to $225 million in the second quarter of 2024. This change was led by Zyaflex and Sacralin, which grew approximately 9% and 13% respectively in the second quarter of 2025, compared to the second quarter of 2024. Zyaflex achieved another strong quarter, driven by an increase in price and volumes associated with steady growth and underlying demand due to continued patient and healthcare provider education. Looking forward, we continue to see growth potential in diagnosis and treatment rates. The sterile injectable segment reported revenues of $87 million in the second quarter of 2025, compared to $91 million in the second quarter of 2024. This change was primarily driven by competitive pressures on adrenaline vials and vasostrict. It was only partially offset by increased revenues from the adrenaline ready-to-use bags. and increased volumes across several other sterile injectable products. On a sequential basis, sterile injectables revenues increased 23% compared to the first quarter of 2025. In the second quarter of 2025, we expanded the adrenaline RTU bag product line with the addition of an eight milligram concentration to the existing four milligram concentration that was launched in the fourth quarter of 2024. We also continue to advance sterile injectables pipeline and now have four FDA submissions through the end of the second quarter of 2025. We continue to remain on track to complete seven FDA submissions and three product launches in 2025. The generic pharmaceutical segment reported revenues of $119 million in the second quarter of 2025 compared to $110 million in the second quarter of 2024. Revenues from the lidocaine patch grew 31% compared to the second quarter of 2024 and 38% compared to the first quarter of 2025, primarily driven by higher volumes as we continue to respond to market supply dynamics. The competitive landscape continues to remain relatively stable and our contract manufacturing partner continues to increase capacity to address growing market share. Finally, The international pharmaceutical segment reported revenues of $13 million in the second quarter of 2025, compared to $21 million in the second quarter of 2024. This decline was the result of the previously announced divestiture of the international pharmaceuticals business. It was completed on June 17th. I will now turn the call over to Brian, and we'll discuss Mallinckrodt's second quarter results.

Thanks, Mark. Legacy Mellencraft maintained our positive momentum, again delivering strong performance in the second quarter. Mellencraft's net sales in the second quarter of 2025 were $485 million, as compared to $514 million in the second quarter of 2024, reflecting a 6% decrease on a reported and constant currency basis, excluding the impact of the Theracos divestiture total net sales grew by 9%. Net income for the second quarter of 2025 was $2 million, an improvement from a net loss of $43 million in the second quarter of 2024. Adjusted EBITDA in the second quarter of 2025 was $137 million, as compared to $174 million in the second quarter of 2024. This was driven by strength in Axar gel largely offset by the impact of the Cerakos divestiture, incremental commercial investment for Axargel, and the impact of nitric oxide competition in the United States. Let's take a closer look at Legacy Mallinckrodt's two business segments, starting with specialty brands. Specialty brand segments reported net sales of $254 million, is compared to $275 million in the second quarter of 2024. This 4% decrease includes the impact of the Theracose divestiture. Excluding Theracose, specialty brands' net sales grew by 28%. The primary driver of this growth was Axar Gel, which generated net sales of $175 million in the second quarter, an increase of 49% compared to the prior year period. This significant growth, which represents the highest growth for AXA brand in more than a decade, was driven by rising category awareness, prescriber-based expansion, and improved patient affordability. In addition, we're nearly a year into the highly successful launch of our Self-Check device, which has been a strong growth driver for the brand. Enthusiasm for Self-Check has translated into strong referral rate. with self-check now counting for over 80% of all new ACT-R referrals in the second quarter. We also saw growth across all therapeutic areas this quarter, a great indicator of momentum for ACT-R gel overall. Turning to Inomax, net sales were 62 million in the second quarter, a decrease of 7% compared to the prior year period. Those sales in the U.S. continue to be impacted by competitive pressures We are pleased with the growth we saw in Japan, where sales increased 27% compared to the second quarter of 2024. Our multi-year rollout of the evolved DS delivery system into U.S. hospitals continues to progress well. As of quarter end, we had more than 700 devices placed in over 80 hospitals nationwide. By the end of 2025, we expect that evolved devices will be used to deliver the majority of nitric oxide of Ina-Max therapy in the U.S. Cervivaz generated net sales of $8 million in the second quarter, an increase of 51% compared to the prior year period. This reflects 23% hospital demand volume growth versus the second quarter of 2024, in line with our expectations. We continue to believe in the opportunities ahead for this treatment as an important option for patients with HRS and their caregivers. Now moving to specialty generics. Specialty generic segment reported net sales of $221 million as compared to $240 million in the second quarter of 2024, a decrease of 8%. This year-over-year decline reflects a difficult comparison with the prior period when high demands for our finished-dose products driven by market constraints and shortages translated to peak sales volumes. Generic performance was impacted by competitive pressures on finished-dose opioids and APAP products, somewhat offset by strong performance in finished-dose ADHD and addiction treatment product standards. In API, we are encouraged by signs of a turnaround in the APAP market. positive indicator moving forward. I'll now hand the call back to Siggy for the combined company's 2025 financial guidance and some closing remarks.

Thanks, Brian. For 2025, we expect total company net sales to be between $3.57 billion to $3.62 billion, and adjusted EBITDA between $1.1 billion to and $1.13 billion. For 2025, we expect power health net sales to be between $1.72 billion and $1.75 billion, and adjusted EBITDA between $450 million and $470 million. As a reminder, the guidance ranges for adjusted IPTA do not include transaction-related compensation expenses related to the merger. In terms of key products, we expect strength in ACTA performance to continue, and accordingly, we are raising our 2025 net sales guidance for ACTA from a high single-digit range to a 20% to 30% range. With Siaflex continued momentum and strong performance, we are reaffirming guidance for Siaflex revenues to grow in high single digits in 2025. As we think about the rest of the year, there's a lot to look forward to. Our teams are already beginning to implement our integration plans and bring the benefit of this merger to life. We have also been encouraged by our conversation with our external stakeholders, from investors to our partners in the healthcare community, about their excitement for the merger. We will be announcing our new corporate name in the coming weeks, and following the planned spin-off of ParHealth, the branded therapeutics company is expected to be listed on the New York Stock Exchange, subject to approval of our board of directors. Before we wrap up, I wanted to express my gratitude to the Mallinckrodt and Endo teams for their commitment and dedication to helping both companies to get to where we are today in terms of both today's results and the completion of the merger. They have been instrumental to our collective success, and I deeply thank everyone for their involvement and efforts today. The future of our combined company is bright, and I'm confident in the value we can deliver to our shareholders, employees, customers, and patients. And with that, I will now open it up for Q&A.

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touch-down phone. If you wish to cancel your request, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. Once again, that is star 1 should you wish to ask a question.

It appears we do not have any questions, so we thank you all for joining us today. We look forward to engaging with you in the days and weeks ahead. If you have any questions, the best way to contact us will be by email, and we will work to get back to you as soon as possible. Thank you again for joining us.

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may all disconnect your lines.