Endo Inc

Good morning and welcome to today's conference call to discuss the proposed combination of Mallinckrodt TLC and Endo Inc. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. If at any time during this call you require immediate assistance, please press the 0 for the operator. Please be advised that today's conference is being recorded. A copy of the investor presentation is available on the investor relations pages for both companies' websites. I would now like to hand the conference over to Laurie Park, Senior Vice President, Investor Relations and Corporate Affairs at Endo. Please go ahead. Thank you, Liyue, and welcome everyone.

During this conference call, the participants may make certain forward-looking statements relating to the transaction and the financial condition of both companies, results of operations, plans, objectives, future performance, and businesses. We caution you that actual results could differ materially from those that are indicated in these forward-looking statements due to a variety of factors. Information concerning those factors can be found in the company's filings with the SEC. This call does not constitute an offer to buy or sell 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 Malincroft and Endo, Mallinckrodt intends to file with the SEC a registration statement that will include 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 may 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 of proxies in connection with the business combination and about their interest in the solicitation. Now let's turn to slide three. On today's call, you will hear from Mallinckrodt's Chief Executive Officer, Siggy Olofsson, and Chief Financial Officer, Brian Reasons, as well as Scott Hirsch, Endo's interim CEO, and Mark Bradley, Endo's CFO. With that, I will turn the call over to Siggy.

Thanks, Lori. Good morning, everyone. I'm pleased to be here with Scott to announce the combination of our two companies. This is an important and exciting step in the continued execution of the strategies for both Marlin Croth and Endo. Marlin Croth and Endo are both diversified pharmaceutical companies with branded and generic businesses. Together, we will create a global scale, further diversified industry leader with additional capabilities, expertise, and resources to support growth and value creation. On a pro forma basis, we expect to generate 2025 revenue of approximately $3.6 billion and adjusted EBITDA of $1.2 billion with an adjusted EBITDA margin of 34%. There are also meaningful synergy opportunities we expect to achieve at least $150 million of annual pre-tax run rate by year three, and approximately $75 million in the first year. Importantly, the combined company will have a strong balance sheet and ample financial flexibility to invest in innovation, business development, and growth opportunities, both organic and external. On today's call, we will walk through the transaction, our vision for the combined company, and the meaningful benefits we believe it will deliver for both company shareholders and other stakeholders. Additionally, both Malincrot and Endo reported financial results for fourth quarter and full year 2024 this morning. We will take some time on this call to discuss those results before we open the floor to you for questions. Turning to slide five, we'll spend a moment on the portfolios. Our two businesses are highly complementary. On the brand side, we both have durable on-market products and portfolios focused on unmet patient needs, including rare and orphan diseases. Marlin Cross-branded portfolio is led by Achtar DL, Inomax, and Turlevas, We are in the midst of two ongoing launches for the next generation product with our ACTAR Self-Direct device and INOMAX Evolve DS delivery system. Endos branded portfolio includes the leading Siaflex, SuperLin LA, and Avid franchises. On the sterile injectables and generic side, we both have extensive capabilities across the value chain as well as complementary portfolios and capabilities. Mylencrott has a diversified portfolio of high-quality generic drugs and active pharmaceutical ingredients. This has been delivering double-digit growth driven in large part by our ability to consistently and reliably deliver high-quality products. Endo has a broad portfolio of sterile injectables, including approximately 40 on-market hospital-based products and a pipeline of more than 40 projects currently in development. Endo also has over 80 generic products on the market across range of delivery technologies, dosage forms, and formulations. Importantly, both companies are well-established industry players with robust commercial and manufacturing infrastructures. And both of our teams have deep clinical and regulatory expertise to drive approvals of complex drugs and devices together with experience commercializing complex and highly regulated products. Turning to the structure on the transaction on slide six, which we can think about in two steps. The initial step is the transaction we are announcing today, combining Mallinckrodt and Endo. After the close of this transaction, we plan to establish two focused businesses designed to pursue distinct value-maximizing strategies, a leading scaled brands business and a focused sterile injectables and generics business. then for the second step we intend to pursue a separation of the combined injectables and generics business from the broader combined company this separation would enable us to ultimately move forward as a scaled and diversified pure play branded pharmaceutical company with a strong balance sheet and a cash flow profile to invest in growth an enhanced commercial position and an executable growth story, we will be well positioned to create equity multiple expansion. The combined sterile injectables and generics business will also be poised for success with a complementary product portfolio, leading control substances franchise, robust commercial and manufacturing infrastructure, extensive supply chain capabilities, and strong compliance culture. This business is expected to be highly profitable and generate strong free cash flow. Separating it from the combined company would unlock additional value by enabling the consistent return of capital to shareholders. This separation will be subject to approval by the combined company's board of directors and other conditions. Slide 7 outlines the key terms. Under the terms of the agreement, Endo shareholders will receive a total of 80 million in cash, and Endo shareholders will own 49.9% of the combined company on pro forma basis. After cash consideration, Malenkrot shareholders will own 50.1% of the combined company on a pro forma basis, for the implied pro forma enterprise value of $6.7 billion. Mallinckrodt will be the holding company for the combined business and Endo will become a wholly owned subsidiary of Mallinckrodt. At close, I will serve as the president and CEO and as a member of the board of directors of the combined company. Paul Efron, who is currently a member of the Endo board, will serve as the combined company's board chair. The new board is expected to have a total of nine directors, including three additional directors from Mallinckrodt, three additional directors from Endo, and one new external director. We will announce additional leadership team appointments and the names of the other directors prior to closing of the transaction. The transaction has been approved by the boards of both companies and is expected to close in the second half of 2025, subject to approval by shareholders of both companies, regulatory approvals, and customary closing conditions. The combined company will have a strong balance sheet. On a pro forma basis, we expect to have a net leverage of 2.3 times at closing. Malincrot and Endo will finance the transaction with cash in hand and $900 million of committed financing provided to Endo by Goldman Sachs. Following close, Malincrot's headquarters in Dublin, Ireland will serve as the combined company's global headquarters. The location of the combined company's U.S. headquarters, as well as its name, will be announced in due course. I will now turn the call over to Scott to speak more about our combined businesses.

Thank you, Siggy, and thank you all for joining us on this exciting day for Endo. It occurred to me this morning that this is only my second earnings call here at Endo, and yet in this short time, we find ourselves announcing two transformative transactions this week after beating our 2024 budget, meeting our RAISE 2024 guidance, generating record Ziaflex revenues exceeding $500 million, and looking forward to a 2025 guidance with revenue growth for the first time in half a decade. I would usually end with gratitude, but today I want to start by thanking my Endo teammates, who I've been so impressed by and proud of for their tireless and selfless efforts to create the environment for growth and for this transaction. I met Siggy almost 15 years ago when Watson acquired Actavis, and from both our many investor meetings together and our time working on this transaction, I know we share the view that a company is the output of its people. Our combined teams, the collective skills in bringing to market specialty pharmaceutical products across a wide range of therapeutic conditions, from rare disease, urology, neonatology, orthopedics, and hepatology, along with the collective manufacturing breadth, will provide the go-forward opportunity for this transaction. Now on slide eight, let's walk through an overview of the combined branded business. Bringing together Mallinckrodt's and Endo's branded pharmaceutical portfolios will add both scale and diversification with multiple on-market brands. The brand's portfolio will comprise leading pharmaceutical products across a range of therapeutic areas. This includes two high-growth power brands, Endo Xyaflex and Mallinckrodt's Actar Gel. Xyaflex benefits from an exciting pipeline of new indication expansions, and Actar Gel is positioned for continued growth following the recent launch of its self-check device. The combined portfolio of well-established on-market products will enhance the commercial portfolio of the business, which will be poised to deliver very strong growth. This pure play branded business will have the attractive cash flow profile and balance sheet capacity to opportunistically pursue strategic business development and external growth opportunities. On a pro forma basis, this business delivered 2024 revenues of $1.7 billion. Turning to slide nine, which shows the combined sterile injectables and generics business. This business will bring together two highly complementary product portfolios. Our products together span multiple delivery technologies, dosage forms, and formulations, including patches, powders, liquids, and pre-filled syringes, and covers a wide range of therapeutic areas. The business will also benefit from robust commercial capabilities, established manufacturing infrastructure, and an extensive supply chain capability. Our experienced teams bring deep expertise in complex, highly regulated products and share a strong commitment to quality and compliance that will underpin all operations. We also see opportunities for backward integration of API. On a pro forma basis, 2024 revenues for the combined injectables and generic business were $1.7 billion. Turning to slide 10, the combined company, including both the branded business and generics business, will benefit from significant scale and capacity. At closing, we will have approximately 5,700 employees and a heavily U.S.-focused footprint, with 30 distribution centers and 17 manufacturing facilities, including 7 facilities for the combined brands business and 10 for the combined sterile injectables and generics business. Additionally, outside of the U.S., we will have capabilities and resources on four continents. I'll now hand it back over to Siggy. to discuss future growth opportunities and wrap up the transaction portion of this call.

Thank you, Scott. Turning to slide 11. With a strong balance sheet, the combined company will have ample financial flexibility to enable the combined company's strategic focus, and we see multiple avenues of growth for the branded business. In the near term, we plan to pursue business development opportunities. Longer term, we will have the resources and flexibility to pursue innovation across our platform. One particular category we are excited about is rare and orphan diseases, where both Malincrot and Endo have strong foundations through ActaGL, Ternivas, and Supraline LA. Together, we will be positioned to expand our leadership and help address significant unmet patient need. Over time, we may also look to expand into other strategic therapeutic areas. In summary, we believe this combination represents a unique opportunity for both Malincroft and Endo to deliver significant value, not only for our stakeholders, but for our patients, customers, healthcare providers, and other stakeholders. I will now turn the call over to Scott and Endo CFO Mark Bradley to discuss Endo's financial results. Scott.

Thanks, Siggy. I will now provide a brief Endo performance and business update. Mark Bradley will then walk you through the financial results in 2025 Outlook, and then we will turn it back over to Mallinckrodt to review their results. Starting with slide four in Endo's deck that is posted on the Endo's IR website. 2024 was a year of meaningful progress and milestone achievement toward Endo's ongoing transformation. Full-year 2024 total revenues of $1.8 billion and adjusted EBITDA of $637 million were in line with our increased guidance expectations for the year. As we expected, our year-over-year revenue performance progressively improved each successive quarter throughout the year. Our 2024 revenue performance was anchored by Zyaflex. with total revenue growth of 9% and exceeding the 500 million mark for the first time. Full year 2024 Zyaflex revenues grew high single digit across both on-market indications driven by strong underlying demand. We also advanced our sterile injectables business. In the fourth quarter, we launched three sterile injectable products, including adrenaline RTU bags, which is our seventh ready-to-use product. In addition, we received our first US FDA approval for our new sterile manufacturing facility in Indore. This is a significant milestone for Endo as we continue to invest and innovate in our sterile injectables business. I want to make note that you will see this investment show up in our forward expectations within the cost of goods line versus the R&D line, as the sterile injectables investment is really operational versus clinical. Lastly, earlier this week, we announced an agreement to divest our international pharmaceutical business to Knight Therapeutics. We believe this transaction provides a provides clear benefits to both parties. It continues our ongoing transformation and sharpens our focus on our core growth businesses. My gratitude to our Paladin colleagues for their unparalleled professionalism. Turning to the next slide and diving into the segment level performance. Starting with the branded pharmaceutical segment, fourth quarter 2024 branded and Zyaflex revenues were comparable to the prior year on a reported basis. However, as a reminder, fourth quarter 2023 revenues or the comparator period, included a one-time benefit of approximately $14 million related to the application of the final Inflation Reduction Act for Zyaflex. Including this one-time benefit in the 2023 comparator period, year-over-year branded segment and Zyaflex revenues grew a healthy 7% and 11% respectively in the fourth quarter of 2024. During the fourth quarter of 2024, both Zyaflex indications delivered strong revenue growth. Excluding the one-time benefit in fourth quarter 23 I just mentioned, fourth quarter revenue from Peyronie's disease and Dupuytren's contracture grew 9% and 15% respectively compared to prior year. This revenue growth was primarily driven by an 8% increase in Zyaflex volume due to strong underlying demand coupled with an increase in average net selling price. This performance reflects the results of our continued efforts to increase consumer awareness and patient access along with our focus on the provider experience. Additionally, during the fourth quarter, Suprella and LA revenues increased by 9% as well compared to the prior year driven by underlying demand. Moving to the sterile injectable segment, fourth quarter 2024 revenues were $92 million compared to $96 million in the prior year. The change was primarily driven by competitive pressures on vasostrict, offset partially by increased volumes across multiple other products in the portfolio. Turning to the new product launches, I am very pleased with the strong fourth quarter performance from adrenaline RTU bag, which we introduced early in the quarter. We intend to increase both the availability of supply and the base of customers for adrenaline RTU during the first half of 2025 with increased pull-through and additional presentations in the second half of the year. Fourth quarter 2024 generic pharmaceutical segment revenues were $111 million compared to $139 million in the prior year. Lidocaine patch revenues increased 46% compared to the prior year as we continue to provide the market with reliable supply. This growth partially offset competitive pressure across a number of products, including dexalanzoprazole, delayed-release capsules. Fourth quarter 2024 revenues from the international pharmaceutical segment were 17 million, essentially unchanged compared to the prior year. Moving on to the next slide and diving deeper into our Zyaflex franchise, We remain bullish on Zyaflex as a durable and long-term growth driver for the company. Looking back over the past 10 years, Zyaflex has grown at a compound annual growth rate of 15%. The current diagnosis and treatment rates for both on-market indications remain low, providing the opportunity for continued future growth. To drive continued growth, we plan to invest in the direct-to-consumer activation, the patient and provider experience, and potential future musculoskeletal and urological indications. Lastly, we continue to believe that Zyaflex is protected by a robust IP estate as well as high barrier-to-entry market dynamics. Turning to the next slide, sterile injectables and acute care capabilities continue to represent an attractive growth option for us. Last quarter, I shared that we launched a thorough review of our sterile injectables business, our capabilities, and the commercial opportunities of the projects in our sterile injectable and generic pipelines. This comprehensive review confirmed our strategy, our focus on ready-to-use and differentiated products, and our know-how and capabilities to succeed in this segment. As a result of this review, we made changes to personnel, we made changes to our prioritization, and in turn, we are making the additional investments into our sterile injectable operations to drive execution. The pipeline efforts for SI now report directly to me. As part of this updated effort, we have decided to focus on a reduced number of projects across the portfolio, which will provide us with increased probability of success against this prioritized pipeline. We believe these changes will help us better leverage our sterile injectable capabilities, improve execution, and position us to deliver growth in the segment. Our sterile injectables pipeline continues to be heavily focused on differentiated products that help reduce complexity and improve efficiency in the hospital and acute care settings, with approximately 60% of the pipeline being ready to use and differentiated projects. In 2025, we expect to launch approximately three sterile injectable products and submit seven FDA filings. Since the beginning of the year, we have already completed two of these FDA submissions. Looking forward, we expect to launch approximately 20 products over the next three years, and we plan to provide updates on both our submissions and our launches as the measure of our progress. We believe the successful launch of these new products will drive our sterile injectables business to grow between mid and high single-digit compounded annual growth rates over the next five years. Before turning the call to Mark, I want to again thank our team members for their commitment to our patients and delivering life-enhancing products. With that, let me turn the call to Mark, who will take us through the rest of the financial discussion.

Thank you, Scott. Turning to slide eight, I'll start with a summary of our enterprise revenue and non-GAAP financial results for fourth quarter 2024 compared to prior year. As Scott mentioned, fourth quarter 2024 revenues decreased compared to prior year primarily due to competition across multiple products in our generic segment. Fourth quarter 2024 adjusted EBITDA decreased slightly compared to prior year as lower revenue and slightly higher operating expenses were partially offset by slightly higher adjusted gross margin. Fourth quarter 2024 adjusted net income was approximately $70 million compared to approximately $151 million in the fourth quarter of 2023. This decrease was primarily due to an increase in interest and adjusted income tax expenses compared to prior year. We ended 2024 with approximately $387 million of unrestricted cash and cash equivalents and a net debt to adjusted EBITDA ratio of approximately 3.3 times. According to my final slide, we expect full-year 2025 revenues to be between $1.78 billion and $1.86 billion, and adjusted EBITDA to be between $620 million and $650 million. Our full-year 2025 guidance does not incorporate the impact from the divestiture of the international pharmaceuticals business, which is expected to occur in the middle of 2025. Our full year 2025 revenue guidance range reflects a low to mid single digit growth rate compared to 2024. This reflects a high single digit growth rate in Xiflex revenue, expected growth in revenue from recently launched sterile products, including the adrenaline RTU bags, and expected growth in revenue from the lidocaine patch. This anticipated growth is expected to be partially offset by competitive pressures on several products across all portfolios. Our full year 2025 adjusted EBITDA guidance assumes an adjusted growth margin of approximately 64% and operating expenses between $590 million and $610 million. Adjusted growth margin reflects changes in business mix as well as additional investments in our sterile injectable manufacturing network. Operating expenses reflect continued advertising and promotional investments to support the growth of Xiflex on-market indications, investments to support the development of new Xiflex indications, and investments to support the development of new sterile injectable product candidates. I would like to note that adjusted EBITDA is expected to be lower in the first half of 2025 than 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 from recently launched sterile injectable products, including the adrenaline RTU. Operating expenses are also expected to be higher in the first half of the year. Accordingly, we expect our net debt to adjusted EBITDA ratio will increase through the first half of 2025 compared to the fourth quarter 2024, and then decrease through the second half of 2025. For reconciliation of all non-GAAP numbers, to the most directly comparable GAAP financial measure, please see the reconciliations in the appendix to the presentation. I will now turn the call over to Mallinckrodt's CFO, Brian Reasons, to review Mallinckrodt's results.

Thanks, Mark. Before diving in, I'll note that unless otherwise specified, the net sales percentage changes we discussed are on a constant currency basis. 2024 was truly an outstanding year for Mallinckrodt. We achieved the high end of our net sales guidance range for the full year, and this was despite having only 11-month sales contributions from Theracos, which we completed the sale of at the end of November. We also achieved the midpoint of our raised adjusted EBITDA guidance for the year. Across our businesses, we are proud to return a key brand, Acthargel, to growth, bring two new innovations to the market, and deliver an exceptional year of double-digit growth in our specially generic segment. Our results underscore our strong performance and the successful execution of our strategy, as our teams have been focused on stabilizing our base businesses and positioning Mellancroft for long-term growth. Turning to our financial results for the fourth quarter and full year, as well as our 2025 guidance, Mellancroft's total net sales in the fourth quarter were $492.1 million as compared to $469.3 million in the fourth quarter of 2023, reflecting a 4.9% growth on a reported basis and a 4.8% growth on a constant currency basis, excluding Theracos net sales grew by 11.5%. Adjusted EBITDA in the fourth quarter of 2024 was $124.2 million, essentially flat compared to the $123.8 million in the prior year period. This stability was driven by strength in both the specially generic segment and ACTHAR gel, largely offset by approximately $9 million of transaction-related compensation expenses related to the sale of Theracose, the impact of the Theracose transaction, incremental commercial investment for Acthar Gel and Turlavaz, and the impact of nitric oxide competition in the United States. The specialty brand segment reported net sales of $265.6 million in the fourth quarter of 2024, as compared to $270.7 million in the fourth quarter of 2023. Excluding Theracos, specialty brand net sales grew by 8.9 percent in at 8.9%. In terms of results by each product, ACT-R net sales were $138.8 million in the fourth quarter, up 33% compared to the prior year. Our fourth quarter growth was largely driven by the successful launch of Selfject in August of 2024, which was responsible for over 70% of the new ACT-R brand prescriptions. as well as an overall prescriber enthusiasm and patient demand. Looking to 2025, we expect positive momentum in our rollout of self-check to continue and anticipate full-year net sales growth for Axar gel to be in the low single-digit range. Ionamax generated net sales of $60.8 million in the fourth quarter, a decline of 14% compared to the prior year period. InaMax performance continued to be impacted by competitive pressures in the U.S. throughout the year. This said, we began the multi-year rollout of the InaMax Evolve DS delivery system into U.S. hospitals last March. We believe that this is an important, innovative offering that will drive stability for the brand as we continue hospital and provider engagement to expand adoption over time. Turlevaz generated net sales of $6.1 million in the fourth quarter, an increase of 8.9% compared to prior year period. We're seeing signs of positive traction for Turlevaz with 15% higher hospital demand in the second half of 2024 versus the first half of the year. We continue to have conviction in Turlevaz as the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function. The specialty generic segment reported net sales of $226.5 million as compared to $198.6 million in the fourth quarter of 2023. Growth was driven by strong performance in finished-dose products, increased demand for controlled substance API, and Mellicrot's differentiated position as a consistent supplier of high-quality products. We also continue to see softening demand in the APAP business from excess supply in the broader market as customers adjust their inventories. Moving forward, we will continue building on our strong market position in this segment and expect to deliver flat to low single-digit net sales growth in 2025. For the full year, Mallinckrodt reported full year net sales of $1.98 billion, an increase of 6.1% compared to the prior year. An adjusted EBITDA of $603.7 million, an increase of 5.6%. Excluding the impact of Theracose business, adjusted EBITDA grew 12.9%. Turning to our guidance for the full year fiscal 2025, We expect total net sales of between $1.7 billion and $1.8 billion, and adjusted EBITDA of between $480 million and $520 million. Mallinckrodt has positive momentum as we move into the new year, and we are all energized to keep pushing forward, advancing our strategic priorities, and delivering results while we work toward closing the combination with Endo. I'll now turn the call back to Siggy.

Thank you, Brian. In closing, I'd like to recognize the talented Mallinckrodt team. This transaction is a testament to their contributions, which have enabled us not only to achieve but surpass our goals. It has taken a lot of hard work to get us to where we are today, and I'm grateful for their continued commitment and dedication to our company and the patients, healthcare providers, and customers we served. We'll now open it up for your questions.

Thank you so much. And ladies and gentlemen, you will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. And should you wish to decline from the polling process, please press the star followed by the number two. And if you're using a speakerphone, please lift the handset before pressing any keys. And one moment, please, for your first question. Our first question comes from the line of Les Liski of TruViz Securities. Your line is now open.

Good morning. Thank you for taking my questions and very interesting transaction in this time. Perhaps maybe just start off on the how can we think about the MergeCo as an entity? You know, which categories do you plan to invest in? I did pick up that you wanted to, I guess, a little bit investment towards the rare disease front, but maybe Any other specific areas? And then how do you think about kind of the pipeline and the R&D engine internally? Or are you more inclined towards the BD plans and across the branded portfolio? And I do have a follow-up.

Thanks for that. It's Ziggy here. If we focus on it, I think you need to think about this transaction as in a way that we are establishing two distinct businesses the branded pharmaceutical business, and the specialty injectables and generics business. How I think about it is the branded business is growing. You know, it's exciting, two strong brands on the market with Siaflex and Actar, and quite a few other smaller brands which make an impact and has a huge impact, and patients need those brands. I think both companies have mainly been focused in expanding the current brands on the market. That has been the focus on the R&D effort in-house today. Not so much has been done outside. I think as you see from our presentation, when this combination happens, this changes the scene completely the opportunity is with a much stronger balance sheet you saw at closing our net debt will be 2.3 times so there will be an opportunity for investment in r d probably to begin with look for opportunities in business development You know, it depends on at which states which we would license that in. I think we need to work on what therapeutic areas we could go. The beauty of this transaction is this specialty brand company will cover so many therapeutic areas, as Scott mentioned, and we could even go into a new one. So it's an open opportunity for us. We have the balance sheet. We have the team. We are excited about that. On the generics and sterile injectables, I'm very excited about the injectable pipelines that Endo is working on. As I mentioned in my points, over 40 projects are being worked on. I have a little bit of a background from my previous job in working in the U.S. injectable business, and I'm excited with the projects that they are working on on the ready-to-use portfolio to bring to the market. And maybe there is more opportunity there. On the generic side, I think there will be continuing there, but more I think the first focus will be to deliver the pipeline of the sterile injectables to the market. And then, of course, there's an opportunity in the active pharmaceutical ingredients. But that business will have a very strong cash flow in that business unit. And what we see in the branded business is the balance sheet will allow us to do this business development we talk about. So that's in a way the fundamental of the excitement around this combination.

I appreciate all that color, Sigi. And maybe just to touch on the generics, what's the rationale on the separation? And have you gauged interest across different counterparties?

No, so no decision has been done. The board will make a decision on the separation when the time comes. What we want to do is to, when this deal closes, which we expect in the second half of the year, we will work on integrating the sterile injectables and the two generics businesses into one unit. And then we make the best decision going forward and the timing to do that of the separation. But we are excited. There are opportunities with a much larger portfolio. I think the combined company, the combined businesses will be one of the larger generics and sterile injectable businesses in the U.S. has amazing customer service, has really a good manufacturing platform, focused on U.S. platform, but also outside of the U.S., which is so good in today's competitive environment in generic. So we haven't explored any further steps than identifying that we want to combine the businesses, and then we will make decision on the next steps.

Excellent color. Maybe last one for me. Can you just provide a little bit more color around the $150 million expected in synergies? Is this mostly across Apex, or is there any sort of overlap across the portfolio that can be reallocated? And is there any synergies across marketing and sales that could enhance the branded portfolio specifically? Thank you, and congrats on the transaction.

Yes, so on the synergies, how we are thinking about that, we are basically two fully fledged companies that are getting together. So there will be an overlapping roles for sure, which we will identify during in preparation for the integration. But really where the opportunity is, is obviously around the infrastructure of the company, better use of resources. We will be a stronger purchaser as a combined company. We are buying more. We have doubled the size that individually the company was before. So we feel good about this synergy opportunities. There is small things like buying information data from external sources. Both companies invest hugely in that part of the business. Just to give you a small example of how we think about it. In terms of sales and marketing, As I sit here today, we haven't made the prediction. I think the impact there will not be very little because we are in distinct therapeutic areas, and we want to continue the sales with the sales force in place. We can never say never, but as I'm sitting here today, I think the impact on sales will be minimal, if any, because we want to grow these businesses. We have many brands that we want to support, so that is not the focus and the source of the 150 million incentives.

Great. Thank you for the additional color, and congrats on the transaction. Thank you.

Thank you so much. And your next question comes from the line of Douglas Chow of H.E. Rainwright. Your line is now open.

Hi, good morning. Thanks for taking the questions and congrats on the transaction. So I guess, Siggy, maybe as a start, I'm just curious in terms of business development to build up the branded business, which seems to be a focus. I'm just curious, you know, what stage of development are you going to be looking for assets? Will they be largely commercial assets or will you be looking for assets in different stages of development as well? Thank you.

Yeah, good morning, Doug. So I think the opportunity for us is we need to think in the beginning, especially around the risk profile of this company. So I don't see this company going into any research or early development. We simply are not at that stage. But we obviously need to evaluate. And in my mind now, I think we can evaluate products in phase three, early commercialization or commercial brands that have synergies with our current therapeutic areas. As I mentioned, we have a wide reach in terms of our sales force, and that's an opportunity. And we also will be a very well and strong established U.S. brand company. There might be a European player that are looking for partners for their development product to bring to the U.S. So I feel there is a lot of opportunities in the business development front due to the wide range of therapeutic areas Due to the knowledge and expertise we have, I think both companies have expertise out of this world in market access. Both companies have very challenging products in market access. Akhtar, obviously, one of the more complex products in that category. Syaflex, the same. I think both companies have shown they do an excellent execution, and we could be, I think, a good home for products going forward in the U.S. brand market.

And maybe as a follow-up, Siggy, I know, you know, Mallinckrodt had had a focus on immunology. Will you sort of stick to the same therapeutic areas or will there be some sort of expansion just given the fact that you'll be doing orphan disease? It doesn't necessarily take a huge commercial investment to go into your category. Thank you.

Yeah, so we are not basically fixating us on our current therapeutic areas. I think we will start the exploration based on current to gain some synodys. You know, we would be able to get maybe some sales synodys if we introduce a second product into like urology with Cyaflex or into immunology with ACT-R. But we are not eliminating anything. I think it's unlikely we go into therapeutic areas where the big farmers are competing. I probably wouldn't see this company, although no decision is made, that we would enter oncology. That's not our core. But we are covering so many of the other therapeutic areas where the competition and the opportunities are for us to put our foot down.

Okay, great. Thank you.

Thanks, Doug.

Thank you so much. And again, if you would like to ask a question, please press star 1. And this concludes the Q&A session. I will now hand the call back to Siggy for closing remarks.

First of all, thank you, everybody, for joining us today. On behalf of both company management teams, we are really eager to hit the ground running as we work to complete the transaction and realize the full potential of this combination. I want to congratulate employees of both companies. Both companies have done amazing jobs over the last two years, two, three years in refinding the core of the business, serving patients that led really to this combination today. Thank you.

Thank you so much, and thank you all for joining today's conference call. You may now disconnect.