Amneal Pharmaceuticals, Inc. Q3 FY2024 Earnings Call

Hello, everyone, and thank you for your patience. The Amneal Pharmaceuticals Third Quarter 2024 Earnings Call will begin shortly. Thank you. Good morning and welcome to the Amneal Pharmaceuticals Third Quarter 2024 Earnings Call. I'd now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo. Please go ahead.

Good morning and thank you for joining Amneal Pharmaceuticals' third quarter 2024 earnings call. Today, we issued a press release reporting Q3 results. The earnings press release and presentation are available at amneal.com. Certain statements made on this call regarding matters that are not historical facts, including but not limited to, management's outlook or predictions are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements for factors that may impact future performance. We also discuss non-GAAP measures. Information on the use of these measures and reconciliations to GAAP are in the earnings release and presentation. On the call today are Chirag and Chintu Patel, co-Founders and co-CEOs; Tasos Konidaris, CFO; our commercial leaders, Andy Boyer for Generics; Joe Renda Specialty; and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

Thank you, Tony. Good morning to everyone. We're excited to talk about our strong Q3 results. Our entry into the obesity and metabolic disease space with Metsera collaboration and our recent launch of CREXONT for Parkinson's disease. Q3 was an excellent quarter as we continue to drive sustainable growth and took actions to solidify our long-term growth profile. First, I'll discuss our recently announced collaboration and entry into the global obesity space. The GLP-1 market is prime for innovation and expanding access to this novel class of therapies. And with Metsera, we are poised to deliver new, high-quality medicines at scale. Metsera is a clinical-stage biotech company purpose-built for advancing the next generation of weight loss medicines. They have a rich proprietary library of peptides with a pipeline of innovative injectable and oral therapies. Amneal's high-quality manufacturing and operational expertise is complementary to Metsera's drug discovery capabilities. This collaboration is an important milestone for Amneal and underscores the strength of our capabilities and our reputation as an industry leader. Amneal is Metsera's preferred global supplier in the United States, Europe, and other markets and has been granted a license to commercialize Metsera products in select emerging markets, including India and certain countries in Southeast Asia, Africa, and the Middle East. We will leverage our existing infrastructure and build two new world-class manufacturing facilities in India to support the initiative. Importantly, this collaboration creates a new high-growth vector for Amneal with multiple avenues for value creation in a rapidly growing space that is estimated to reach over $100 billion by 2030. It is a logical extension of our strategy, deep expertise in complex pharmaceutical manufacturing and our track record of delivering high-quality innovation at scale. Second, we are incredibly excited about the recent launch of CREXONT, which is an important achievement for the company. This new and innovative treatment advances the standard of care for patients with Parkinson's disease, providing a longer duration of good on time with less frequent dosing. Chintu and I met with key opinion leaders and prescribers at the Movement Disorder Society Congress recently, and there is tremendous excitement for CREXONT. As an organization, we have deep expertise in the Parkinson's space for over 10 years as we have commercialized Rytary. The CREXONT launch is off to a strong start. We are confident in our ability to further expand our specialty segment, including the potential to add branded opportunities over time. Next, in the affordable medicines business, which is our generic segment, we continue to expand our portfolio with new products that are driving continued growth. Year-to-date, revenue growth is 12%. The first growth area is retail and particularly complex generics. Amneal has been number one in the United States complex generic therapy innovation since 2018. We have launched, on average, 30 or more new products each year. This has driven tremendous diversification with oral solid generics decreasing from over half of the company's total revenue in 2019 to less than a quarter this year. Our affordable medicines business is foundational to Amneal and will continue to drive meaningful value for the company. The second growth area is injectables. Our portfolio of over 40 products continues to expand with over 10 new launches expected each year. In 2024, we launched our first 505(b)(2) products, which are differentiated, ready-to-use solutions that can improve hospital pharmacy efficiencies by eliminating medication preparation steps. Overall, the U.S. injectable market continues to face supply disruptions, which Amneal is addressing head-on. Today, Amneal provides 13 injectables currently on the shortage list, and we are proactively working to help alleviate other market shortages. The third growth area in affordable medicines is biosimilars; we have built a strong foundation with our first three commercial similars. Also, we have planted the seeds for long-term growth by in-licensing five more pipeline biosimilars, all expected to launch by 2027. In Q3, we took an important step in in-licensing omalizumab biosimilar for the brand name Xolair into our pipeline, another high-value therapeutic. This product is roughly $4 billion-plus in the global market that expands our portfolio beyond oncology to allergy. Overall, biosimilars are the next wave of affordable medicines in the United States, as about 60% of upcoming pharmaceuticals face loss of exclusivity by value are biologics. Accordingly, the U.S. biosimilar market is estimated to grow from $4 billion to $5 billion today to $20 billion to $30 billion by 2032 from a manufacturer's net sales perspective. New biosimilars provide enhanced access to affordability and value for patients. We are building a significant biosimilar portfolio and will be vertically integrated over time as we see biosimilars as a key growth vector for Amneal in the long run. Next, international expansion is a long-term growth area for us. In India, we are building a customized portfolio of products. In other markets, we are registering select products with our partners to start supplying in Q4. We expect international expansion to add $50 million to $100 million in revenues by 2027. Finally, the healthcare distribution business continues to deliver double-digit growth, driven by all three channels: distribution, government, and unit dose. We expect over $700 million in healthcare revenue in 2025. Overall, we could not be more excited about how well positioned Amneal is to drive continued growth. Today, Amneal is a diversified global pharmaceutical company that provides access to high-quality, affordable, and essential medicines for patients, providers, and payers. We have purposefully and strategically expanded our business and added new vectors for growth. I will now pass it to Chintu.

Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family who wakes up every day with energy and passion to make healthy possible. I will discuss our core strengths in operations, innovation, and how Amneal continues to thrive, and then I will share how we will utilize our vast experience and capabilities in the GLP-1 space, which is a new growth vector for Amneal. First, in operations, quality is at the center of everything we do. Our world-class global operations have an industry-leading quality track record, and we had multiple successful inspections at our sites over the last quarter. Across our organization, we are investing in automation, digitization, and AI technologies to advance our global infrastructure. We are driving operational excellence, Kaizen cost improvements, and skill development programs to enable our next generation of capabilities and growth. We see operational excellence, high levels of customer fulfillment, and a robust supply chain as the key competitive advantages for us, as the recent storms in the U.S. remind us that drug shortages, particularly for injectables, remain a U.S. supply challenge and we are working hard to be part of the solution. Second, in innovation, we launched CREXONT in September, which is a remarkable new treatment for Parkinson's disease that will benefit many patients. We are hearing testimonies from patients that CREXONT is changing their daily lives. Its unique and novel formulation is designed to provide rapid onset of action and extended efficacy to deliver more 'good on' time with less frequent dosing. As a leader in the Parkinson's space, we are working to bring this new therapy to patients quickly and are pleased with early adoption. Another specialty R&D program we have been working on but had not disclosed prior to approval is extended-release Pyridostigmine Bromide. This product is a once-daily pretreatment for protection against soman gas and other chemical agents and was developed in close collaboration with the U.S. government for use by military personnel. Our new drug application was approved in October. Our next specialty R&D program is DHE auto-injector for migraine and cluster headache, which can save patients from having to make emergency room visits during these very painful episodes. We are on track for our NDA response in Q4, which would put us in a good position to launch in Q2 of next year once approved. Next, I will touch on our complex generic portfolio. With over 20 product launches so far this year, we are on track to launch three new products again in 2024. We expect this cadence of innovation to continue with 79 new products pending approval, 63% of which are non-oral solids, and 57 pipeline programs in development for non-oral solids. Within our R&D organization, we have enhanced our efficiency and capabilities to develop more complex products on a faster timeline at a lower cost. As a result, we are allocating more investment towards external R&D over time, especially in biosimilars and specialty. In injectables, we have launched 11 new products so far this year, including our first 505(b)(2) products primarily for the treatment of non-small cell lung cancer, nausea associated with oncology treatment, and potassium phosphate ready-to-use IV bags. We have developed our 505(b)(2) injectable portfolio based on stakeholder feedback and have built a curated pipeline of injectable presentations with over 15 505(b)(2) injectables in development. Our other complex injectable R&D programs continue to advance in our pipeline, including microspheres, liposomes, and drug-device combinations. Next, we see inhalation as a new growth vector ahead for Amneal. We have a series of high-value launches planned over the next several years that will utilize our ready and approved Ireland manufacturing sites. We have inhalation programs across the major device categories, including dry powder and metered-dose inhalers and the Respimat platform. We are excited about our inhalation pipeline, with our first inhalation product pending approval soon and many more to come in the years ahead. Next, in biosimilars, we are strategically focused on expanding our portfolio. Building on the success of our first three commercial products, we have in-licensed five additional biosimilar pipeline candidates. We are filing our BLAs for two denosumab biosimilars for Prolia and XGEVA in Q4. Next, we expect to file the pegfilgrastim onboard injectable and prefilled auto-injector products in Q1. After that, we expect to file the BLA for omalizumab, a biosimilar for Xolair, by the end of 2025. We will add more molecules to our pipeline to expand our biosimilar portfolio and look to be vertically integrated over time. We remain very excited about biosimilars as a key vector of growth, as many biologic products will face loss of exclusivity in the coming years. Internationally, we have distribution partners in place for key developed and emerging markets, registering products globally, including in Europe and emerging markets. International expansion remains a key area of focus for us at Amneal as we look for significant growth opportunities ahead. Let me now turn to our entry into the GLP-1 space. Today, Amneal has existing infrastructure and capabilities for developing peptides and finished products. As part of the Metsera collaboration, we will build two new state-of-the-art GLP-1 manufacturing facilities. One facility will be for producing peptide drug substance and the second for advanced sterile fill-finish manufacturing capability to produce high volumes of finished products. Amneal will provide its expertise and infrastructure for formulation development and other CMC activities and will also serve as Metsera's preferred global supplier. As we look ahead, we plan to utilize our leading innovation, operational capabilities, and quality track record in developing and manufacturing complex pharmaceuticals in this new fast-growth category. In summary, when Chirag and I returned as co-CEOs in 2019, we laid out a strategy for diversification and growth. Since then, we have executed this plan. We are a deeply purpose-driven company on a mission to provide access to affordable innovation. Today, Amneal is growing in key areas of medicine, specialty branded, biosimilars, injectables, complex generics, and now GLP-1s, extending access through our distribution and international business. As we celebrate our success over these last five years, we are focused on execution and are excited for the next five years. I will now pass it over to Tasos.

Thank you, Chintu, and good morning, everyone. We're very pleased to report another terrific quarter with strong revenue and adjusted EBITDA growth, robust cash generation, and continued debt reduction. I'll first discuss our third quarter and year-to-date results, then move on to cash flow and capital allocation priorities. In the third quarter, revenues grew 13% to $702 million with continued growth across all our three business segments. Our generics, what we also call our affordable medicines business, grew 9% to $427 million. This terrific performance was driven by the strength of new product launches which in turn helped improve shortages and provide exceptional value to our customers, payers, and patients. New products launched in 2023 and 2024 contributed $35 million to Q3 revenue growth, and biosimilars generated $31 million in revenue. Amneal's continued R&D innovation, superb quality track record, and consistency of supply are competitive advantages driving sustainable value creation and diversification. Let me now move to our Specialty segment, where revenues grew 19% to $116 million, driven by our branded products. Our Parkinson's franchise, which now includes CREXONT, Rytary, and ONGENTYS, delivered $61 million in revenue and contributed $17 million to Q3 revenue growth. CREXONT's quarterly revenue was $3 million due to the initial launching. One month post-launch, we are pleased with the early indicators of commercial uptake, inclusive of prescription trends, physician and patient testimony, as well as insurance providers interested in making this new therapy available to their patients. In the third quarter, our outpatient care business grew 21% to $159 million, reflecting continued growth across both the distribution and government channels. New product launches and continued strong execution by the team are key drivers of this strong performance. Amneal's overall gross margin of 44% in the third quarter was up 30 basis points compared to the same quarter last year, reflecting our new product launches as well as our team's efforts to reduce costs and improve efficiencies in a sustainable way. Moving down the P&L, Q3 adjusted EBITDA was $158 million, reflecting robust revenue growth, SG&A expense leverage, and includes $20 million related to the licensing of a proposed biosimilar to Xolair that we announced last July. Excluding this milestone payment, adjusted EBITDA growth in Q3 was approximately 15%. From an EPS perspective, Q3 adjusted EPS of $0.16 declined $0.03 as higher adjusted EBITDA was offset by interest expense. Looking at our performance during the first nine months of the year, we are pleased by the quality of execution by all our teams. Total company revenues of $2.1 billion are up 16%, while adjusted EBITDA of $472 million is up 13%. It's worth noting that all our business segments have contributed to this growth, and we have thoughtfully increased our investments in R&D and commercial teams as we build a durable high-growth company for many years to come. Turning now to cash flow and the balance sheet. Our strong financial performance and discipline is translating into higher cash generation and continued delevering. Consequently, over the last three quarters, we have paid down $127 million in gross debt and reduced our net leverage to 4.2x at the end of September 2024, compared to 4.8x in December 2023. Furthermore, I am pleased to report that we now expect to finish this year at a net leverage of about 4x, one year ahead of our original target, and we continue to intend to drive further delevering towards 3x in the next few years. From a capital allocation perspective, we continue to prioritize investments to further diversify our business and drive sustainable growth. We can expect us to continue making targeted investments in areas such as Parkinson's, biosimilars, injectables, and inhalation. Within R&D, as Chintu mentioned, we are reallocating spend towards higher growth areas while maintaining the yearly productivity of our R&D pipeline. We're very excited about our recent GLP-1 collaboration, given its growth potential and our ability to properly support it well within our cash flow profile. In summary, we're laser-focused on delivering near-term consistent financial performance while taking strategic actions to further solidify our long-term growth. Let me now turn the call back to Chirag.

Thank you, Tasos. Our bold strategic vision for Amneal is becoming a reality more and more each day. Over the past five years of the journey, we focused on transforming and diversifying the business. In retail generics, we shifted our portfolio focus to complex products starting back in 2019. In 2020, we acquired the healthcare distribution business to add new channels to drive access to our products. Then in 2021, we started expanding our injectable business by adding new products, capabilities, and capacity. In 2022, we launched our first biosimilars and built our initial pipeline from there. Internationally, we have laid a strong foundation for long-term growth. The launch of CREXONT and our entry into the GLP-1 space in Q3 are very significant milestones for the company. As we execute our strategy, further diversify, and drive sustainable growth, we are building Amneal as a leading diversified global pharmaceutical company. Let's now open the call for Q&A, Tony?

The first question comes from David Amsellem from Piper Sandler.

So, just have a few. I wanted to start with CREXONT. I know early days regarding the rollout. But can you talk about the reimbursement landscape, particularly Part D, and how we should think about access? And regarding adoption, how are you thinking about that in the context of the eventual loss of exclusivity for Rytary? So that's number one. Number two is on your injectable business. I know you've talked about shortage products, and you've also leaned into more complex products. Trying to get a better sense of the mix, the topline mix for injectables with respect to shortage products and more complex products? And how do you think that mix will evolve over time as you continue to build that part of the business? And then lastly, a product-specific question. I believe you've been developing an intranasal epinephrine product. Any updates on that would be helpful.

Good morning, David. So CREXONT is off to a great start. We are actually pleasantly surprised by how the product is doing. It's like CREXONT is marketing itself and access so far has been good with initial coverage; it's just been a few months, and great discussions with the rest of the payers. We expect to get more coverage than Rytary based on what the product is doing. So that's the answer to your first question. LOE of Rytary, which is August 1, 2025, should not have much of an impact at all because we're expanding the market. We're targeting pretty much all qualified patients who should be taking CD/LD and converting the market from IR. We have the naive patient labeling, and from Rytary or other small portions of the XR, all of them can take CREXONT, which is the most advanced product today available for Parkinson's patients. There is no excuse why they shouldn't all be on it. So we're going for a massive market share for this product. This is why we're pricing it affordably; we have done extensive work to set it up properly and we are receiving the feedback we had expected for the market access. So no impact on LOE; obviously, we'll lose LOE on August 1, but CREXONT, ONGENTYS, and the other growth drivers of the company continue to drive tremendous growth for 2025 and beyond. Your second question on injectables and complex products, I'll hand it to my brother, but we're doing both shortage products and complex products and continue to provide both while converting the compounded products, which often comes under FDA scrutiny for GMP reliability. We launched potassium phosphate recently, and it has been very well received in the market. It's clear that everyone prefers to use FDA-approved products rather than compounded ones. We're working on a few more, but Chintu can shed a little bit more light on it. Go ahead, brother.

On injectables, we are very excited with our pipeline and infrastructure and the time we spent over the last four years in creating this. We have a good mix of complex products and shortages are very hard to predict; however, we have the capabilities and capacity to mix the product well. We are always working with the FDA's drug shortage group proactively. We keep an eye on drug shortages. We are very purpose-driven when it comes to shortages and how we can help alleviate them. Our portfolio is nicely balanced across different categories of injectables. We have LBB bags; some of them always go on a shortage, and we have excess capacity. We also have the vial capabilities, PFS, and we have the immersion line like products such as Propofol, where we plan to get capacity to cater to shortages as they happen. We have a strong complex portfolio, including microspheres and expect to receive our first microsphere product approval in the next quarter or so. We have liposomal products and suspension-based products. I believe this is a very mixed revenue perspective, but of course, complex will drive significantly more revenue and topline than the shortages, and we have the right sized infrastructure. We have about 30 pending approvals at the FDA, so our injectables portfolio is strong. It is very hard to predict percentage-wise due to the uncertainties of shortages. Regarding Neffy, we are very excited about our Adrenaclick auto-injector; that product is doing really well. This is an emergency drug. We are not expecting any challenges to our current business; in fact, it's growing and it’s preferred by parents. Regarding Neffy, we have capabilities in a unique dose nasal spray. As of today, we are not seeing any impact or expect to see any impact moving forward for our current product. We will provide more highlights into our plan going forward for a unit dose major epinephrine.

The next question is from Balaji Prasad.

Firstly, congratulations on the Metsera deal. Looking at it, it seems to have the potential to redefine Amneal over the longer term. So my first question is on that. Can you provide a bit more on the financials around the deal? What does this mean in terms of incremental CapEx for Amneal over the coming years and the balance sheet back? And maybe also discuss the longer-term goals that you have with this deal? That's one. Two, maybe a follow-up on CREXONT. Could you describe in detail a bit more on the feedback with the product now? How has the protocol emerged for converting from existing drugs, Sinemet to CREXONT or Rytary and competition from other products too.

You are correct, the Metsera deal positions us for the next generation of growth. It is a groundbreaking partnership as it's strategic for us in peptides and biologics. We expect further announcements in a similar vein. This collaboration requires us to create significant capacity and capabilities to supply peptides-based products, initially around obesity and metabolic disease, and we aim to seek more partnerships beyond Metsera, also approaching large players like Lilly, Novo, and Roche for CMO work. This is strategically significant for us as we set ourselves up for GLP entry with substantial capacity. As for the financial terms, as disclosed, Metsera is providing $100 million towards the CapEx; our net expense over the next four to five years is projected at about $50 million to $200 million, which is well within our budgets. The first phase will occur in India, but we will also ensure some production takes place in the U.S. for both oral and injectables in the future. Regarding CREXONT, CREXONT is a very novel product. It stands out in comparison to other continuous pumps that have launched and are for more advanced patients costing $120,000 annually. CREXONT is a daily-use solution for naive patients as well as advanced patients and aims for broader patient coverage. Our marketing strategy is aimed at acquiring all business from naive patients to Rytary patients to those on Sinemet and competitors like AbbVie. Our product has shown significant innovation, and the affordability allows for wider access, which aligns with Amneal's philosophy.

Yes, Balaji, thanks for the question around CREXONT. Our goal has always been to demonstrate that we are the number one company in the Parkinson's space. The addition of CREXONT absolutely allows us to do that. There are three key aspects to our strategy regarding your question. One was ensuring that patients saw this product as one that they had accessibility to and were excited about, and we are very pleased with the response we received from the Parkinson's community. The second aspect, which relates to your question on conversion and dosage, focuses on the healthcare providers. We needed them to see CREXONT as differentiated and clinically distinct from other products in the market. The good news is the feedback we've received indicates that healthcare providers absolutely see CREXONT as a clinical differentiator, and their feedback has been that the dosing is very easy for them to convert, whether it be from a Rytary patient or a patient on CD/LD, or a naive patient, as Chirag mentioned. Lastly, to your question about market access strategy, that was our third strategic component: ensuring we secured access comparable, if not broader, than what we saw with Rytary, which had approximately a 70% national average access. With CREXONT, we're very pleased with the positive responses from payers so far. We've already secured a few deals, and we are eyeing at least 50% coverage by next year. Based on the current trend and ongoing discussions, it seems likely that we will achieve that or even exceed it next year. This sentiment reflects the positive reception we've gotten from payers regarding CREXONT.

That's very helpful. If I could just add in a follow-up question here. Chirag, you even discussed making America a priority on multiple firesides in the past, including during last year's CEO panel. With the change in administration coming, can you talk about the implications of America-centric manufacturing for generics and biosimilars and how that could influence Amneal's growth strategy over the coming years?

Yes, thanks, Balaji. We have an urgent issue as a country regarding emergencies; we need to build a resilient supply chain. By resilient, I mean having multiple locations and countries supplying goods, embodying both onshoring and nearshoring approaches. In cases of extreme situations—horrific events like warfare or pandemics—we might face challenges importing critical medications. The vital 40 to 50 products we have been advocating in Congress and the White House are receiving bipartisan support and there's a growing receptiveness to this agenda. Legislative changes now create an open market for anyone willing to invest in America to build plants that supply these critical medicines. We're optimistic that we can get this initiative accomplished this time around.

The next question is from Leszek Sulewski from Truist Securities.

I just want to focus on the GLP-1 Metsera partnership. After that announcement, has this raised awareness of your manufacturing capability? Have you been approached by other clinical-stage peptide biotechs for similar partnerships? And then remind us of your current capacity in sterile injectable peptides, and how much additional volume would you anticipate from the new facilities? What percentage of that increased capacity do you anticipate will be allocated to Metsera's products versus capacity to capture other brands, including Lilly or Novo? Lastly, is there a path for you to capture the generic side of some of these blockbuster GLP-1s once they face loss of exclusivity? What do you expect the response will be from some of your manufacturing competitors in the space?

Let me start with our current capacity. On the PFS cartridge, we can make up to 5 million units, which is a small capacity for peptide API today. In the next few years, in about three years, we would increase our capacity to produce 5 to 10 tons of API drug substance and 100 million combination of PFS and cartridges, depending on what our client chooses for full assembly. This outlines our capacity strategy for the next three years. Yes, we have indeed been approached by major players about potential collaborations. We will explore opportunities to help these companies introduce such important drugs globally and help provide affordable access to these markets, which is significant. Regarding the generic side of things, we expect to be prepared to supply GX products at the time of loss of exclusivity, and we can easily scale to produce an additional 100 million units if necessary because our infrastructure is already being built out. That is the strategy for us in the GLP-1 and the broader peptide space, and we also see potential to expand into enzyme-based products. As it relates to competitors, this is a unique partnership that took us around a year to forge, based on trust and collaboration, focusing on co-developing the products and assisting with CMC, clinical, and production aspects. This model is uncommon, and while others may attempt similar partnerships, we haven't seen anyone else doing this just yet.

The next question is from Chris Schott from JPMorgan.

Congrats on all the progress on the business. Just three for me. Maybe first on business development. Can you just talk about the landscape for deals here? It just seems like the business is growing; you get more capabilities for investing behind assets. Just maybe a little bit more color on the size and stage of assets you're most interested in? The second question is around biosimilars. Just talk a little bit about the opportunity and competitive landscape you're considering in that market? And then finally, just on 2025, any initial color you can provide in terms of just thinking about pushes and pulls as we think about the outlook for next year?

Thank you, Chris. So on the business development front, as we continue to focus on deleveraging, we have that in mind, but we do generate operating cash flow of over $300 million. We do have certain capabilities as we work towards lowering our leverage ratio into the threes. The deals we’re interested in acquiring are centered in two areas: specialty products, where we can add strategic value with the foundational resources we have including our R&D capabilities and commercial teams. We have received many opportunities that we see as smart additions, especially as we focus on oncology and complex products that can complement our existing pipeline. The second focus will be expanding our biosimilar portfolio, where we want to be part of the core competition targeting major players like Sandoz, Celltrion, and Amgen. We want to develop around eight to ten more programs over the next four to five years, enhancing both our R&D and manufacturing capacities. We see this as a huge market, with a projected scope of $20 billion to $30 billion, and globally, the demands for these products could result in a substantial split between U.S. and other markets. Our aim is to lead in this space with robust partnerships. Healthcare distribution remains a great business and the pillars we built over the years, and it is poised for continued double-digit growth due to our direct relationships with hospitals and distributors. As for the outlook for 2025, we are optimistic and feel strong about the progress we've made. I'll pass it to Tasos for further insights.

The question was about early views into 2025 regarding pushes and pulls, positives and negatives. I’ll say a few things. We’ll provide guidance for next year at the end of February, but we feel great about next year. Our company is built for growth, and we believe the management team is positioned to thrive in this environment. We have driven growth for the last five years through a significant revolutionizing of the financial structure, and there is no stopping now. Next year, we expect another year of growth across both the topline, bottom line, and cash generation. As for the tailwinds and headwinds, the significant headwind will be the Rytary LOE. However, this will largely be offset by CREXONT's launch. The biosimilars will continue to grow, and our institutional and injectable product lines are anticipated to expand steadily. Meanwhile, the healthcare segment will continue its strong growth trajectory. In addition, we foresee reduced interest expenses due to our deleveraging strategy. Overall, the expected growth is well-rounded and compensates well for the challenges ahead.

Yes, I think that's a great question, Chris, and I understand the inclination. The Parkinson's franchise as a whole, if we consider CREXONT's initial performance alongside upcoming generics from Rytary, we should expect continued growth next year—despite potential bumps. Although the Rytary LOE might nudge growth just slightly, it poses more of a speed bump than a pothole amidst our larger revenue framework. I've got to emphasize that CREXONT and ONGENTYS will continue contributing as growth drivers up through 2025 and beyond, so overall, the Parkinson's franchise is well poised for positive growth trajectories.

We have no further questions. So, I'd like to hand back to Chirag Patel to conclude. Thank you.

Well, thank you, everybody, and wish you a great weekend. Thank you.

This concludes today's call. Thank you for joining. You may now disconnect your lines.