Amneal Pharmaceuticals - Q3 2024

Transcript

Operator (participant)

Good morning and welcome to the Amneal Pharmaceuticals third quarter 2024 earnings call. I'll now turn the call over to Amneal's Head of Investor Relations Tony DiMeo. Please go ahead.

Tony DiMeo (VP of Investor Relations)

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 discussed non-GAAP measures. Information on 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 for Specialty, and Jason Daly, Chief Legal Officer.

I will now hand the call over to Chirag.

Chirag Patel (Co-founder and Co-CEO)

Thank you, Tony. Good morning to everyone. We're excited to talk about our strong Q3 results, our entry into 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 primed 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 this 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 a tremendous excitement for Crexont as an organization. We have deep expertise working in Parkinson's space for over 10 years as we had 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 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 330 or more new products each year. This has driven tremendous diversification with oral solid generics decreasing from over half of total company's 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 continue 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 solution 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 biosimilars. 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 licensing an omalizumab biosimilar for a brand name Xolair to our pipeline. Another high value therapeutic, this product is roughly $4 billion-plus on a 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' LOEs by value biologics. Accordingly, the US biosimilar market is estimated to grow from $4 to $5 billion today to $20 to $30 billion by 2032. From a manufacturer's net sales perspective, new biosimilars provide enhanced access, 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 will be adding $5.2 billion revenues by 2027.

Finally, the healthcare distribution business continues to deliver double-digit growth driven by all three channels, distribution, government, and unit dose, and now we expect over $700 million in healthcare revenue in 2025. Overall, we could not be more excited with 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'll now pass it to Chintu.

Chintu Patel (Co-founder and Co-CEO)

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 portfolio where Amneal continues to thrive. Then I will share how we will utilize our vast experience and capabilities in the GLP-1 space which is a new growth factor 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 a key competitive advantages for us. As the recent storms in the U.S. remind us, drug shortages, particularly for injectables, remains 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 which 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 these 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 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 30 new launches 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, 93% of which are non-oral solids. Within our R&D organization we have enhanced our efficiency and capabilities to develop more complex products on faster timeline at 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, fosaprepitant for 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 we have built 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, liposomals, and drug-device combinations. Next, we see inhalation as a new growth vector ahead for Amneal's. We have a series of high-value launches planned over the next several years that will utilize our ready and approved Ireland manufacturing site. We have inhalation programs across the major device categories, including dry powder and metered dose inhalers and the RespiMeds 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 BLA for pegfilgrastim on-body injector and pre-filled 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 face LOE in the coming years. Internationally, we have distribution partners in place for key developed and emerging markets. We are registering products globally, including in Europe and emerging markets. International expansion remains a key area of focus for us at Amneal as we look to 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 product.

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 capable of producing high volumes of finished product. Amneal will provide its expertise and infrastructure for formulation, development and other CMC activities and also serve as Metsera's preferred global supplier. As we look ahead we plan to utilize our leading innovation and 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 on that plan. We are 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 and extending access to our distribution and international business. As we celebrate our success over these last five years, we are focused on execution and so excited for the next five years. I will now pass it over to Tasos.

Tasos Konidaris (CFO)

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 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, or 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 help 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 also biosimilars generated $31 million in revenue.

Amneal's continued R&D innovation, superb quality track record and consistency of supply, our true 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 stacking one month post launch. We're pleased with the early indicators of commercial uptake inclusive of prescription trends, physician and patient testimonials, as well as insurance providers interest in making this new therapy available to their patients. In the third quarter, our AvKARE 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 manage costs and improve efficiencies in a sustainable way. Moving down the P&L, Q3 adjusted EBITDA of $158 million reflects 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're 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 on the balance sheet, our strong financial performance and discipline is translating into higher cash generation and continued delivering. 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'm pleased to report that we now expect to finish this year at a net leverage of about four times, 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.

Chirag Patel (Co-founder and Co-CEO)

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 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 and A. Tony.

Operator (participant)

Thanks, you. To ask a question, please press star, then one on your telephone keypad now. And if you change your mind, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. The first question comes from David Amsellem from Piper Sandler. Your line is now open.

David Amsellem (Managing Director)

Thanks. So just have a few wanted to start with Crexont and 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 top line 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.

Thank you.

Chirag Patel (Co-founder and Co-CEO)

Good morning, David. So Crexont is off to a great start. We are actually pleasantly surprised by ourselves how the product is doing. It's like Crexontis marketing Crexont and access so far. Good initial coverage. It's just been a few months and great discussion with the rest of the payers. We expect to get more coverage than we reiterate because of 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 this is we're expanding the market. We're going to pretty much all qualified PD patients who should be taking CD/LD and converting the market from IR. We have the naïve patient labeling and from Rytary or other small portion of the XR, all of them to Crexont, which is the most advanced product today available for Parkinson's patients.

There's no excuse why they not all should be on it, so we're going for a massive market share for this product and this is why we're pricing affordability. We had 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. LOE in August 1st but Crexont and the other growth drivers of the company continue to drive growth for 2025 and beyond. Tremendous growth for Amneal. Your second question on injectable complex. I'll hand it to my brother but we're doing both the shortages and complex products continue to provide both and also we are converting the compounded products which always gets into the FDA's crosshair for the GMP and other reliability. We had our first launch of potassium phosphate just recently and it is when received really well in the market. It's pretty much everybody wants to use FDA approved product rather than compounded products and we're working on few more. But Chintu can shed a little bit more color on it and I think what was oh Neffy that I also have Chintu cover the Neffy one. Go ahead brother.

Chintu Patel (Co-founder and Co-CEO)

Hey, David. Good morning. So on injectables we are very excited with our pipeline and infrastructure and the time we spend over last four years in creating this. So we have a very good mix of complex products and shortages are very hard to predict. But we do have the capabilities and capacity and the mix of the product and we are always working with FDA drug shortage group to proactively work as and when we get a request. We keep an eye on the drug shortages. We are very purpose driven when it comes to shortages and how we can help alleviate the shortages. So our portfolio is very nicely balanced in different categories of injectables. We have IV bags, some of them always goes on a shortage and we have excess capacity. We have vial capabilities PFS, we have the emergent line like product like propofol.

We have plenty of capacity so we'll be able to cater to the shortages as and when they happen. We have a very good complex portfolio also in microspheres. We expect to receive our approval in the next quarter or so. For our first microsphere product we have liposomal, we have the suspension-based product. So I think it's a very mixed revenue perspective. Of course complex will drive a lot more on a revenue and a top line than the shortage. We have the right size infrastructure so that's a very good mix. We have the scientific capabilities of developing even the next generation of complex injectables as we announced with GLP-1 with drug device combination and auto injectors. So very, very nicely balanced portfolio. We have about 30 or so pending approvals at FDA. So injectables is a very good mix.

very hard to say which one, you know, from the percentage because shortages are not known regarding Neffy. We are very excited about our own product. Our Adrenaclick auto-injector is really well. This is the emergency drug and we are not expecting any challenges to our current business. Actually, it's growing. It's a preferred route because of the emergency for the parents. Neffy also, we have the capabilities on a unit dose nasal spray. So as of today we are not seeing any impact or we don't expect to see any impact going forward on our current product and Neffy. So far we have not seen any greater uptake or anything in the market and we will provide more highlights into our plan going forward on unit dose nasal spray of epinephrine. Thank you, David.

Operator (participant)

Thank you. The next question is from Balaji Prasad. The line is now open.

Balaji Prasad (Equity Analyst)

Hi, good morning everyone and 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 financials around the deal? What does this mean in terms of incremental CapEx for Amneal over the coming years and the balance sheet impact and maybe also discuss the longer term goals that you have with this deal. That's one, two, maybe follow up on Crexont. Could you describe in detail a bit more on the feedback with the product now how has a protocol emerged for converting from existing drugs, let's say Sinemet to Crexont or Rytary and competition from other products too. Thanks.

Chirag Patel (Co-founder and Co-CEO)

Hey Balaji, good morning. So you're correct. Metsera deal puts us into the next generation of growth and it is very it's next next level of partnership as well and this is in peptides and biologics and expect us to do more announcement in a similar line. So first of all we create a massive capacity and capabilities to supply peptides based product which is starting with obesity, metabolic disease and then continue to do more partnership beyond Metsera or even approach big players like Lilly, Novo Roche to do CMO work for them. So that is why it's very strategically. How we have set it up.

On top of it, it obviously allows us to get ready for the GLP-1 entry with powerful, I mean big capacity. So there could be 10 pilots but who could really supply globally at high-quality products. And that is what we're setting it up both on oral, on injectables, on a financial terms. As we disclosed, Metsera is providing $100 million towards the CapEx and our net expense over the next four to five years is about $50 to $200 million. So well within our budget. So not a big deal. And this is why we are putting these first phase in India in the future. Obviously we will always like some portion to be produced in the United States both oral and injectables which will do so going forward in the United States as well.

Moving on to Crexont, as I just explained, Crexont is very novel. It's the best in the class right now. It doesn't compete too much with the more even though the results could be the same as a continuous pump that AbbVie launch and that is for more advanced patients at $120,000 a year versus Crexont is a daily use. Naïve patients all the way to the advanced patients can use this. So the universe is so big on just in the United States market. Number of patients and our marketing strategy is we're going after all of that business from naïve to Rytary to Sinemet to AbbVie. Doesn't matter to us. We're because what our product does and what we have seen so far and the affordability of our product that it can have a wider market access.

And this is why we set it up this way because we really wanted to reach many patients. What's the use of innovation if it cannot reach the patients? And that's the Amneal philosophy and that's how we have launched it. Joe, would you like to add.

Joe Renda (Chief Commercial Officer)

Yeah, Balaji, thanks for the question around Crexont. I would just add to what Chirag said is that, you know, our goal has always been to demonstrate the fact that we're the number one company in the Parkinson's space. The addition of Crexont absolutely allows us to do that. And there were really three key aspects to our strategy around your question. One was ensuring that patients saw this product as one that they had accessibility to and were excited about. And we were very pleased with the response we got from the Parkinson's community. The second, which is kind of goes to your question around conversion and dosage. The HCPs were a critical aspect of our second part of our strategy, which was ensuring that the HCPs or healthcare providers saw Crexont as a differentiation clinically different than what they saw in other products in the market.

And the good news is the feedback we've heard is that the healthcare providers absolutely see Crexont as a clinical differentiator. And their response and feedback has been that the dosing is very easy for them to convert, whether it be a Rytary patient or a patient on CD/LD or a naïve patient to Chirag's point. And then last, the question that was asked earlier by David, which is the market access strategy, which was our third strategy component, was ensuring we got access comparable if not broader than what we saw with Rytary, which had about a 70% national average access with Crexont. We're very pleased with the response from the payers so far. We've already papered a few deals and we are looking to go at least 50% coverage by next year.

And the trend that we're on now with some of the deals we're in conversations with looks like we'll probably be able to get that if not more next year. So the access response from the payers has also been very positive. So hopefully that gets to some of the questions you had about Crexont as well.

Balaji Prasad (Equity Analyst)

That's very helpful, thanks. If I could just add in a follow-up question here, Chirag, you and I had discussed Make in America in multiple fireside chats in the past. Even last year's CEO panel at AAM. So 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?

Chirag Patel (Co-founder and Co-CEO)

Yeah. Thanks Balaji. So we have an issue as a country in case of emergencies we need to build resilient supply chain and what I mean by resilient is having multiple locations countries supplying the friend shoring and on shoring because sometimes it would be hard to in the cases of hopefully never happens like wars or some kind of pandemics or natural disaster we could have issues importing antibiotics. The critical 40 or 50 products that we've been lobbying. I've been advocating in Congress and in the White House in both sides of the aisle are completely receptive. We have advanced the agenda for those products. The starting material, API and finished dosage for the Medicare portion which is about 45% to 50% market share. Medicare giving a different reimbursement for those products.

It's legislatively passed, so it's a law and it creates open market for anybody to invest in America, build these plants to supply these critical medicines. So I think we get that done this time.

Balaji Prasad (Equity Analyst)

Thank you.

Tony DiMeo (VP of Investor Relations)

Next question please.

Operator (participant)

The next question is from Les Sulewski from Truist Securities. Your line is now open.

Les Sulewski (VP of Biotech Equity Research)

Good morning. Thank you for taking my questions. Just want to focus on the GLP-1 Metsera partnership. So after that announcement, has this raised awareness of your manufacturing capability and have you been approached by other clinical stage peptide biotechs for similar partnerships and then remind us what is your current capacity in sterile injectable peptides and how much additional volume would you anticipate from the new facilities and what percentage of that increased capacity would you anticipate be allocated to Metsera's product versus capacity to capture other brands including Lilly or Novo. As you mentioned also is there a path for you to capture the generic side of some of these blockbuster, you know GLP-1s come LOE and then lastly what do you expect the response will be from some of your manufacturing competitors in the space? Thank you.

Chirag Patel (Co-founder and Co-CEO)

Les, good morning. So let me start with our current capacity on a PFS cartridge. We can make up to 5 million units, a very small capacity for peptides API as of today. In the next few years, three years or so, we would increase our capacity to make 5 to 10 tons of API with drug substance and 100 million of combination of PFS and cartridges whichever our client chooses to use with full assembly. So that's the phase for next three years on a capacity wise we would. Yes, we've been approached by big guys as well. So we will obviously work with them and see how we can help them to introduce these very important drug globally and create access to other countries as well, affordable access.

So we have that opportunity as well with us and on as far as GX is concerned we would be ready whenever the LOE happens and we will have full capacity to supply GX products at that time. If we need to add another 100 million units we can because the infrastructure will be there and if we have to expand API we will because we have all the capabilities capacity already built in and then just extending the site. So that is the strategy for us to play in GLP-1 or all peptides within the obesity and metabolic space and that could further expand to other peptides enzyme driven products as well.

Les Sulewski (VP of Biotech Equity Research)

Very helpful. Just lastly on that competitor's response. Have you seen anything out there yet?

Chirag Patel (Co-founder and Co-CEO)

No, no. This is a very unique partnership. It took us a year and very old partnership. Knowing it's a trusted partnership and we're doing beyond CDMO work here. We're co developing the products, helping them on CMC clinical and production both oral and injectable side the formulation enhancement. So this is, this is very unique and we haven't seen anybody else doing that but I'm sure people may follow this model.

Les Sulewski (VP of Biotech Equity Research)

Got it. Thank you so much for that color.

Chirag Patel (Co-founder and Co-CEO)

Thanks.

Operator (participant)

Thank you. The next question is from Chris Schott from JPMorgan. Please go ahead.

Chris Schott (Managing Director)

Great, thanks so much. Just 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 and it just seems like the business is growing. You've got more capabilities for investing behind assets. Just maybe a little bit more color on kind of the size and stage of assets you're most interested in. The second question biosimilar Xolair. Just talk a little bit about the opportunity and competitive landscape you're thinking about in that market. And then finally just on 2025 just 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.

Chirag Patel (Co-founder and Co-CEO)

Thank you, Chirag. Good morning. So the business development front as we continue to obviously we want to de-lever so so we have that in mind but we do generate $300+ million operating cash flow. So we do have certain capabilities and we're very very focused on getting down into threes as far as the leverage is concerned. And the deals we're looking at and would be adding is two areas specialty products. And it's very smart additions because we have limited R&D budget and limited cash. But there are so many opportunities that we see and using Amneal's capabilities and thousand scientists and all these CMC and other capabilities clinical we could have a unique partnership on these specialty assets. We could take some of the commercial assets. Oncology is our new focus on a specialty.

So far we've been focused on CNS and we have key products in endocrinology. We're now going in on CO because of the biosimilars. We have a whole pipeline of oncology products, the same touch points. So why not introduce the branded products as well within the same community? We hear that the need for it. It'd be specialty products. So we're not competing with big guys. But there are opportunities. So you will see us doing those deals and bringing those into our specialty pipeline. The second would be biosimilar. We would love to integrate completely and head-on compete with Sandoz, Celltrion, Amgen. So we would like to have a full capacity of development, add on another 8-10 programs which are done. Over 45 years' manufacturing capacity. So full R&D capacity manufacturing at scale like a 30, 40, 50,000-liter scale.

We already do and keep expanding partnership within biosimilars. We want. We see this as a big market. It is, and only seven or eight competitors would pretty much share most of the revenue between them. It's a little broad range. I'm giving $20 to $30 billion. This is manufacturers' net sales. IQVIA could be $50 to $60 billion. That is large, and you can see seven or so companies: Biocon, Sandoz, Amneal, Teva may play, integrated play with Alvotech, Celltrion is there, a couple more will show up, but we sit very pretty to take the leadership role there among the leading companies for biosimilars, and it's a global play. There's a huge demand for these products globally. It could have a split of 60% revenue coming from us, 40% from the rest of the world which will partner for these assets.

Integration of biosimilars on the BD side is a key priority in 2025. AvKARE is a great business but we are keeping it. It's such a great business. It's growing double digits, huge growth opportunity there as we expand into government distribution, partnership with government. We love that business and certain direct distribution to hospitals and consumers like in California for Naloxone. We're distributing directly so it allows us to do direct distribution which is a niche other competitors may not have in our field. As we build Amneal to last for a long time. Then on a biosimilar Xolair, we're the three known competitors at a stage we are at. Celltrion has, I believe, filed the product and us with Kashiv and we expect to file in the second half next year get the approval in pretty much 10 months.

We have a manufacturing would be our partner is doing it in Piscataway, New Jersey, and based on IP, we expect to launch this in 2027, but it's pending IP settlement or however that works out. We're not sure about that.

Chintu Patel (Co-founder and Co-CEO)

Chris just wanted to add on Xolair. Also, our partner is uniquely positioned to have all the strengths, both the even newly launched strengths: 175, 150, and 300, plus the auto injector device. While they are going upon the approval, we'd enjoy the entire range of Xolair differentiated auto injector PFS with different strengths. And a very strong IP position both. That will uniquely differentiate us than our competitors in initial time frame.

Chirag Patel (Co-founder and Co-CEO)

Yeah, and Chris, 25 looks very strong. I'll pass it to Tasos for push and pulls, but we're very excited about 25.

Tasos Konidaris (CFO)

Thanks, Chirag. So I think the question was, you know, early view into 2025, Chris, and any pulls or detractors. So I'll say a couple things, so you know. You know, we'll give you guidance for next year in at the end of February. But we feel great about next year. Our company is built for growth and.

That's how the management team is thinking about the business. We have driven growth for the last five years throughout COVID and kind of engineering this spectacular financial turnaround, and we're not going to stop after five years, so next year we expect another year of growth from both the top line, bottom line and cash generation. That's kind of point number one. When we think about kind of tailwinds and headwinds, the obvious headwind is the Rytary LOE. Now the vast majority of that will be compensated by the launch of Crexont. So that's kind of point number one. So I think that becomes more of a speed bump. The Rytary LOE. In addition, our biosimilars will continue to grow our institutional business. The injectable products we've been talking about, those will continue to grow substantially next year and beyond.

AvKARE will just continue the growth that has been on for the last five, six years. And at the same time, when you think about cash generation, we are at the pinnacle of interest of interest expense. So as we think about next year, we will expect about $30 million of reduced interest expense. And that's a function of two things. Number one is just reflect the fact this year, most likely we will have paid down about $180 million of gross debt. We have already paid $127 million and we probably will pay another $50 to $60 million of gross debt in Q4. So we're cutting essentially a couple hundred million dollars less of interest of gross debt. And then as you know, interest rates are beginning to slowly creep down.

Combination of all these biosimilars, injectables, Crexont and less interest expense will more than offset whatever we lose on the Rytary LOE and put the company in another year of growth. Does that help?

Chris Schott (Managing Director)

That's super helpful. Appreciate all the color. Maybe just one really quick clarification. If I just look at the Parkinson's franchise as a whole, I guess when we combined the very strong launch so far with the Rytary generics, is that a franchise we should expect to grow next year? Obviously over time it grows, but specifically in 2025, do you think you can still grow the franchise between those two assets?

Tasos Konidaris (CFO)

Yeah, I think that's a great question, and I have a tendency of driving my friend Joe here crazy about this. I would say it's a little bit early. It's a little bit early. We're only, only a couple of months into the launch. Obviously, that will be. Obviously that would be out of our objective. But frankly, even if we don't kind of completely offset the LOE loss next year, right, by a few million dollars, in the grand scheme of a, you know, you know, almost $3 billion revenue company, we will be more than, more than able to offset that.

Chris Schott (Managing Director)

Perfect.

Joe Renda (Chief Commercial Officer)

We have also added Ongentys, Chris, which is growing as a part of the franchise.

Chris Schott (Managing Director)

Perfect. Thank you so much.

Tony DiMeo (VP of Investor Relations)

Thank you, Chris.

Tasos Konidaris (CFO)

Thanks, Chris.

Operator (participant)

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

Chirag Patel (Co-founder and Co-CEO)

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

Operator (participant)

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