Endo Inc

Thank you for standing by. Welcome to the earnings conference call for Endo, Inc. This call is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the call over to Lori Park, Senior Vice President of Investor Relations and Corporate Affairs. You may begin.

Thank you. Good morning and thank you for joining us to discuss Endo, Inc.' 's first quarter 2025 financial results. Joining me on today's call are Scott Hirsch, Interim CEO and member of the Board of Directors, and Mark Bradley, Executive Vice President and CFO. We have prepared a slide presentation to accompany today's webcast, and that presentation, as well as other materials, can be found in the Investor section at endo.com. I would like to remind you that any forward-looking statements made by management on today's call are covered under the U.S. Private Securities Litigation Reform Act of 1995, and are subject to significant changes, risks, and uncertainties described in our earnings release and other press releases and in our SEC filings. Actual results may differ materially from those set forth in any forward-looking statements. As previously disclosed, substantially all of Endo International's assets were acquired by Endo, Inc. on April 23, 2024, pursuant to Endo International's plan of reorganization. Endo, Inc.' 's first quarter 2025 financial results reflect the effects of the plan of reorganization and the application of Fresh Start accounts. During this call, all references to first quarter 2025 results refer to Endo, Inc. All references to first quarter 2024 results refer to Endo International PLC. In addition, during today's call, we may refer to non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States and that may be different from non-GAAP financial measures used by other companies. Investors are encouraged to review our current report on Form 8K furnished with the SEC for our reasons for including those non-GAAP financial measures in our earnings release and presentation. The reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures are contained in our earnings release issued earlier this morning, unless otherwise noted therein. This call does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. In connection with the potential combination between Melancrot and Endo, Melancrot has filed with the SEC a registration statement that includes a joint proxy statement of Melancrot and Endo and a prospectus for Melancrot shares. The joint proxy statement prospectus and other relevant documents filed by Melancrot and Endo with the SEC will be available free of charge at the respective companies' investor relations webpages 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, malincrot, 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 of proxies in connection with the business combination and about their interest in the solicitation. As outlined on slide 9, during today's call, Scott will provide a first quarter performance and business update. Mark Bradley will then walk you through the financial results and 2025 outlook, and then we will open it up for Q&A. I would now like to turn the call over to Scott.

Thank you, Lori, and thank you to everyone for joining us this morning. Let's start on slide 11, which provides our first quarter financial performance and recent business highlights. I am pleased that Endo had a good start to the year, with all segments of the business performing in line with our expectations. We had a number of moving pieces during the quarter, including our announced merger with Mallinckrodt and the divestiture of international pharmaceuticals business, and yet the company continued to execute on target. Driven by strong Xiflex performance, and continued lidocaine patch strength, first quarter 2025 revenues were $393 million and adjusted EBITDA was $99 million. Based on this performance, we are reaffirming our full year financial guidance for 2025. Our first quarter performance was anchored by yet another attractive Zyaflex growth performance. Total Zyaflex revenues grew 7% versus the first quarter of 2024 and demonstrated growth across both on-market indications. We also advanced our sterile injectables business. In first quarter 2025, we expanded customer adoption for our adrenaline RTU bag, which was launched during the fourth quarter of 2024. Consistent with our comments last quarter, we invested in our sterile operational and development capabilities, and we progressed our injectables pipeline with three new FDA submissions in the quarter. As a result, we are on track to achieve our sterile injectables pipeline goal of seven submissions and three product launches in 2025. As mentioned last quarter, we announced the planned combination with Mallinckrodt as well as the divestiture of our international pharmaceuticals business. These transactions provide meaningful transformation to the company and are expected to enhance the combined growth potential and value creation. Both transactions remain on track and I will provide more details about our progress in a moment. Moving to slide 12 and diving into the segment level performance. Starting with the branded pharmaceutical segment. Branded revenues grew 4% in first quarter 2025 compared to first quarter 2024. This growth was primarily driven by a 7% increase in Zyaflex revenues compared to the prior year. During the first quarter of 25, both Zyaflex indications delivered solid revenue growth. First quarter 2025 revenues from Peyronie's disease and Dupuytren's contracture grew 9% and 5% respectively. compared to the prior year. This growth was primarily driven by an increase in volumes associated with underlying demand and is reflective of our continued efforts to drive consumer awareness and patient access, along with our focus on improving the provider experience. Moving to the sterile injectable segment. First quarter 2025 revenues were $71 million compared to $98 million in the prior year. This change was primarily driven by continued competitive pressure on vasostrict and adrenaline vials. However, we are seeing strong customer adoption of our recently launched Adrenaline RTU bag. We expect to see continued growth in the Adrenaline RTU customer base throughout the year as we increase the availability of supply and introduce additional dosage forms. Based on this, we expect growth in revenue from the Adrenaline RTU bag to offset ongoing competitive pressure on the Adrenaline vials in the second half of 2025. With respect to the sterile injectables pipelines, I am pleased by the solid progress we have made early this year. Following our previously communicated strategic review and internal realignment, the segment has successfully gained traction in the pipeline build. In the first quarter, we completed three new FDA submissions, and we are on track to achieve our sterile injectables pipeline goal of seven submissions and three product launches this year. We are very happy with the progress from our renewed focus and efforts. First quarter 2025 generic pharmaceutical segment revenues were $99 million compared to $103 million in the prior year. Lidocaine patch revenues increased 16% compared to prior year as we continue to provide the market with reliable supply. This growth partially offset competitive pressure across a number of products, notably DexLanzoprazole delayed release capsules. First quarter 2025 revenues from the international pharmaceutical segment were $13 million compared to $17 million in prior year. This change was primarily driven by the known expiration of a product distribution license that lapsed in fourth quarter of last year. Moving to slide 13, I am pleased by the continued performance of our Zyaflex franchise. The chart on the left shows the growth in first quarter Zyaflex revenues over the past several years. It is important to note the current diagnosis and treatment rates for both on-market indications remain low, providing the opportunity for continued future growth. We remain confident in Zyaflex, remaining a long-term growth driver for the company based on patient adoption and market expansion of our current indications, as well as our development pipeline and durable IP estate. Turning to slide 14. To my previous point, we are continuing investments to drive Zyaflex brand awareness and improve the patient and provider experience. During the first quarter, We launched new campaigns for both Peyronie's disease and Dupuytren's contracture. Our new Peyronie's disease campaign named I Got Somebody encourages men to openly discuss PD and connect with trusted healthcare providers to discuss non-surgical treatment options. In February, we launched our first branded Dupuytren's contracture campaign featuring Steve, a real-life Zyaflex-treated patient, and his spouse. We are also modernizing our go-to-market strategies to leverage artificial intelligence and data science to improve the patient's experience. For example, we are analyzing data from our patient call centers with AI tools to quickly identify and implement solutions to address pain points in customer engagement. Many patients prefer non-surgical treatments for Peyronie's and Dupuytren's. Approximately 90% of commercial patients pay zero out-of-pocket. Therefore, we are working to streamline responses to patients with questions about Zyaflex treatment, questions about providers, or questions about their cost and coverage. This real-time engagement enables us to optimize the flow of information across patient interactions and support our goal of an increasingly productive experience for our patients. Additionally, we believe that a high-touch provider approach focused on education and a seamless Zyaflex acquisition experience will increase physician loyalty and support the preferential use of Zyaflex as a non-surgical treatment option. Accordingly, we recently expanded our new spatial computing injection simulator to help urology specialists refine their injection technique for the administration of Xiflex and the treatment of Peyronie's disease. Our simulator now supports hand and urology specialists to interact with both physical and digital objects using lifelike physical models and digital content through an Apple Vision Pro app. Endospatial Computing Injection Simulator represents a major leap forward in enhancing patient care. We believe this first-of-its-kind educational technology in the pharmaceutical sector will support injection training and help build provider confidence. Turning to slide 15, we continue to explore the potential to drive further Xiflex growth by expanding it to new musculoskeletal and urological indications. Recently, we retained an independent data monitoring committee to complete a blinded interim analysis of our Phase III plantar fibromatosis PFI program. The independent data monitoring committee completed their assessment and recommended we continue the study unchanged. Based on current recruitment status, we expect to report top-line PFI results around year-end. Our plantar fasciitis program remains under review, following results from our Phase IIa clinical study communicated last quarter. In the second half of this year, we plan to initiate development activities across three new indications. These include a Phase I proof-of-concept study for hammer toe, preparations for our first in-human studies for urethral stricture, and an IND submission for arthrofibrosis of the knee post-knee arthroplasty. Like our currently approved indications, these include objective endpoints, which we believe present strong probabilities of clinical success. In all three indications, Zyaflex may offer non-surgical treatment options for conditions where the current standard of care often includes surgical intervention. Turning to slide 16. sterile injectables and acute care capabilities continue to represent an attractive growth pillar. We currently provide approximately 40 on-market sterile injectable products to over 95% of hospitals in the U.S. These products are primarily manufactured in the U.S. at our Rochester, Michigan facility. Following our previously discussed review of the sterile injectables business and pipeline prioritization changes, we believe we are better positioned to leverage our sterile injectable capabilities, improve execution, and deliver growth in this segment. We are actively investing in our pipeline to meet the needs of our customers, which includes essentially every hospital in the country, by providing dependable, high-quality, FDA-approved sterile injectable products. Approximately 60% of our sterile injectable pipeline consists of ready-to-use and other differentiated projects that are intended to help reduce complexity and improve efficiency in hospital and acute care settings. I am pleased by our sterile injectable pipeline progress. Moving to slide 17, I'd like to provide an update on the ongoing transformation of the company. We are actively working toward the merger with Mallinckrodt to create a global, scaled, diversified pharmaceutical industry leader. As I stated in March, we believe this combination will strengthen both businesses and unlock value across the combined branded, generics, and sterile injectable sectors. The combination of our highly complementary portfolios and the ability for each business to focus resources on growth generation will also strengthen our ability to serve patients and customers. Following the combination and subsequent separation of the generic and sterile injectable business, we believe the focused companies will have enhanced financial flexibility to invest in growth opportunities and create value. In April, the antitrust submission was filed, and Mallinckrodt filed a registration statement with the SEC, which included a preliminary joint proxy statement and prospectus. In addition, Our joint transaction planning teams are working very well together. We continue to expect the transaction to close in the second half of the year. Additionally, the divestiture of our international business remains on track. This transaction will enable us to more sharply focus our time, energy, and resources on our core growth businesses while putting these assets in the hands of a company focused on commercializing in Canada. We continue to expect this transaction to close in mid-2025. Before turning the call to Mark, I want to thank our endo team members for their continued commitment and achievement during an incredibly active time. With that, let me turn the call to Mark, who will take us through the rest of the financial discussion.

Thank you, Scott. On slide 19, you will see a summary of our enterprise revenue and non-GAAP financial results for first quarter 2025 compared to prior year. As Scott detailed earlier, first quarter 2025 revenues decreased compared to prior year, primarily due to competitive pressures across our sterile injectables and generic pharmaceutical segments, which were partially offset by growth in our branded pharmaceutical segment. First quarter 2025 adjusted EBITDA was $99 million, compared to $146 million in the first quarter 2024. This change was primarily driven by decreased revenues and a lower adjusted gross margin due to changes in segment and product mix, coupled with investments in our sterile injectables manufacturing network. We also made additional investments in R&D to support the development of our sterile injectables pipeline. First quarter 2025 adjusted net income was $24 million compared to $131 million in the first quarter 2024. This change was primarily due to the decrease in adjusted EBITDA that I just mentioned, coupled with an increase in interest expense. We ended the first quarter of 2025 with approximately $370 million of unrestricted cash and cash equivalents, and a net debt to adjusted EBITDA ratio of approximately 3.6 times. Turning to slide 20, we are reaffirming our full year 2025 financial guidance. We expect 2025 revenues to be between $1.78 billion and $1.86 billion, and adjusted EBITDA to be between $620 million and $650 million. Revenue by segment, adjusted gross margin is a percentage of revenues, and adjusted operating expenses also remain unchanged. As I mentioned in our last earnings call, we expect adjusted EBITDA to be lower and our net debt to adjusted EBITDA ratio to be higher in the first half of 2025 compared to the second half of 2025. This phasing is expected to be primarily driven by Xiflex revenues, which are typically higher in the second half of the year, as well as the ramp-up in revenues in the second half half of the year from recently launched sterile products, including the adrenaline RTU bag. Operating expenses are also expected to be higher in the first half of the year. Finally, it's important to note that our 2025 guidance does not reflect the impact from the divestiture of the international pharmaceuticals business, which is expected to close in the middle of 2025. Additionally, our 2025 financial guidance does not include any potential impact related to tariff or trade policy changes. We believe our potential tariff exposure is manageable, considering that four of our five primary manufacturing sites are in the U.S., and approximately 70% of our revenues are from products produced in the U.S. Having said that, our generic segment has the most exposure to potential tariffs, specifically on imports from India. To mitigate potential tariff exposure, we are assessing inventory levels for several key on-market products that are currently produced outside of the U.S., and evaluating the future commercial production location for certain sterile injectable pipeline products. I will now turn the call over to Laurie to manage questions. Thank you, Mark. Operator, can we have our first question, please?

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Just a reminder, if you would like to ask a question, please press the star 1 on your telephone keypad. And if you would like to withdraw your question, you may do so by pressing star 2. With that, our first question comes from the line of pre-shipper with JP Morgan. Please go ahead.

Hi, thanks for taking my questions. I know you said that the first half is going to be weaker than the second half, but the EBITDA that we had in the quarter, from a cadence standpoint, 16% of what your midpoint EBITDA is for the year. Last year is in that mid 20% range. Can you just give us an idea as to how we should think about that ramp in EBITDA and why you feel comfortable in reaffirming your EBITDA guidance?

Yeah, sure, Rishi. Thanks for the question. So as I mentioned in the prepared remarks, the first quarter, it wouldn't be appropriate to analyze the first quarter because of the fact that Zyflex is typically lower, primarily lower in the first quarter than in any other quarter. And as I also mentioned, we do expect revenue from recently launched sterile products to ramp up in the second half of the year. So when you look at the trajectory of revenue, it is much higher in the second half of the year than in the first quarter. And that translates also to a higher gross margin percentage in the second half of the year versus the first quarter. And as I also mentioned, we are making investments in R&D to support our sterile injectable pipeline primarily, as well as the investments to support PFI and some other branded indications and that timing will subside over the year, so we'll have lower operating expenses in the second half of the year than in the first quarter or the first half of the year. So when you take all of these things into consideration, you do see a step up in the second half of the year both on revenue, gross margin, and EBITDA versus first quarter.

Okay. And then just from a follow-up standpoint, can you just speak to the gross to nets in the quarter, how it fared in this quarter relative to last year? And then also considering you're looking to potentially spin off your generic and sterile injectable business, can you just provide us some sense as to how the other segments perform from an operating income or EBITDA basis? Thank you.

So there was nothing unusual about gross to net in the first quarter versus last year. And I don't think we're expecting to see any unusual trends in gross to nets over the remainder of the year. From an EBITDA perspective, the segments performed as expected in the first quarter. And we are expecting them to perform generally in line with our expectations for the full year. There isn't any meaningful differences in our expectations for the segments versus what we had initially indicated earlier.

Thank you.

And your next question comes from the line of Hamed Korsand with BWS Financial. Please go ahead.

Good morning. Could you just talk about the competitive pressures you're seeing in sterile injectables, and how are you managing through that, and were you expecting the ramp in the competitive pressures that you're talking about now?

Sure. Look, I think the most important perspective in SI, right, is to launch products that are meaningfully differentiated, particularly the RTU products that are ready to use or differentiated dosage form or finished delivery mechanisms that make the hospitals very attractive to your products. We did that with the Adrenaline RTU bag late in last year, and we're starting to deploy that across the hospital footprint early this year. As Mark indicated, we expect that to get more traction, both with additional hospitals coming online throughout the year, as well as additional dosage forms. It's important to say as we launch additional dosage forms, we solve the challenge at the hospital network in an increasing form as they continue to look for other sources to complete that full dosage form family. Once we deliver that, we really finalize the solution for them. And so that's an important piece throughout the year. to really offset, as you indicated, the competitive pressures of people trying to solve with other generic forms of the same product.

Great. And my other question was, when it relates to the Zyflex marketing campaign that you're going, is that more to get patients to actually realize you have this drug and it serves this end market, or are you just hoping that it's a you're taking share away from another drug?

So as we've said, the patient adoption rates are still very low for both Peyronie's and Dupuytren's indications, which means that informing patients, getting patients to be aware of a non-surgical option is critical to enhancing the overall market share adoption and interest for the patients to go in. When a patient goes in having seen one of our commercials and asks for product and asks for a non-surgical treatment option, it's a huge benefit for the physician to actually treat with that. And so that's really the driver of both indications right now.

Great. Thank you. Sure.

And there are no further questions at this time. I would like to turn it back to Lori Park for closing remarks.

Thank you all for joining us this morning. We look forward to providing you with updates as we move forward and hope you have a great day.

Thank you, presenters. And ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.