Earnings call: Amneal Pharmaceuticals sees growth and diversification in 2023

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Earnings call: Amneal Pharmaceuticals sees growth and diversification in 2023
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Amneal Pharmaceuticals, Inc. (NYSE: NASDAQ: AMRX ) has reported a robust financial performance for the year 2023, with total net revenue reaching $2.4 billion, marking a significant milestone for the company.

The reported 8% increase in revenues and a 9% increase in adjusted EBITDA underscore the company's successful execution of its growth strategy. Notably, Amneal raised its financial guidance twice during the year and effectively met these targets, reflecting strong operational capabilities and market confidence.

Key Takeaways

  • Amneal Pharmaceuticals reported an 8% revenue increase and a 9% rise in adjusted EBITDA in 2023.
  • The company raised and met its financial guidance twice in the year.
  • A record number of 39 new products were launched in 2023 across various segments.
  • Amneal anticipates over 30 new product launches in 2024.
  • The company expects high single-digit growth across all three segments in 2024.
  • Net leverage is projected to reduce to below 4x by the end of 2024.

Company Outlook

  • Amneal aims for continued growth in adjusted EBITDA and a reduction in net leverage to below 4x by the end of 2024.
  • The company is focusing on international expansion, including filings in emerging markets and Europe.
  • Over 30 new product launches are expected in 2024.

Bearish Highlights

  • The oral solid Generics segment has decreased to 25% of total revenues, down from 53% in 2019.

Bullish Highlights

  • Amneal's AvKARE distribution business has doubled in size over four years.
  • The company is optimistic about the biosimilar market and affordable medicine focus.

Misses

  • There were no specific misses mentioned in the earnings call summary.

Q&A Highlights

  • CEO Chirag Patel discussed the successful relaunch of the sales force for Ongentys and plans to complement it with Rytary and IPX203.
  • CFO Tasos Konidaris expects the profitability profile to increase due to higher profitability of complex businesses and completion of specialty product infrastructure costs.

Amneal's strategic initiatives are clearly paying off, as evidenced by the company's solid financial performance and its ambitious plans for future growth. The company's broad-based business platform and dedicated team have been pivotal in driving this success. Amneal's focus on expanding its Generics portfolio, particularly with complex high-value products, and the growth of its specialty branded business in neurology and endocrinology, are key factors contributing to its positive outlook.

The company's dedication to operational excellence and robust supply chain management has been essential in addressing drug shortages in the US market. Innovation remains a core focus, with a deep pipeline of new products pending approval or in development. The company's international expansion plans are set to file dossiers in emerging markets and Europe, further diversifying its global presence.

Looking ahead, Amneal is well-positioned to continue its trajectory of growth. The planned launch of IPX203 for Parkinson's patients in Q3, pending FDA approval, along with the development of a DHE autoinjector for migraine and cluster headaches, set for a Q1 2025 launch, are anticipated to further bolster the company's portfolio. With a strong emphasis on neurology and endocrinology, Amneal is set to expand its specialty pipeline significantly.

The company's strategic focus on complex products and international expansion, coupled with its commitment to providing affordable medicines, positions Amneal Pharmaceuticals as a company to watch in the pharmaceutical industry. With their eyes set on a future of financial growth, cash generation, and deleveraging, Amneal's management team has expressed confidence in their ability to deliver value and impact the lives of patients worldwide.

InvestingPro Insights

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has demonstrated resilience and growth potential in its recent financial performance, and the data from InvestingPro further enriches the outlook for the company. Here are some key metrics and InvestingPro Tips that investors should consider:

InvestingPro Data:

  • Market Cap (Adjusted): $1.68 billion, reflecting the company's substantial size in the pharmaceutical industry.
  • Revenue Growth: An increase of 8.2% in the last twelve months as of Q4 2023, aligning with the reported revenue increase in the article.
  • Price / Book (Last twelve months as of Q4 2023): 83.79, indicating a high valuation relative to the company's book value.

InvestingPro Tips:

1. Analysts predict the company will be profitable this year, which could suggest a positive shift in Amneal's financial trajectory and supports the company's optimistic outlook.

2. Amneal is trading at a high Price / Book multiple, which may be of interest to investors looking at the company's valuation metrics.

Investors looking for a more comprehensive analysis can find additional InvestingPro Tips for Amneal Pharmaceuticals at https://www.investing.com/pro/AMRX. In total, there are 10 additional tips available on InvestingPro, which could provide deeper insights into the company's financial health and future prospects.

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Full transcript - Impax Laboratorie (AMRX) Q4 2023:

Operator: Good morning and welcome to Amneal Pharmaceuticals Fourth Quarter and Full-Year 2013 Earnings Call. I’ll now turn the call over to Amneal’s Head of Investor Relations, Tony DiMeo.

Tony DiMeo: Good morning, and thank you for joining Amneal Pharmaceuticals Fourth Quarter 2023 Earnings Call. Today, we issued a press release reporting Q4 and full-year 2023 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 in the earnings presentation and our SEC filings for factors that may impact our future performance. We also discuss non-GAAP measures. Information on use of these measures and reconciliations to US GAAP are in the earnings 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, Harsher Singh for Biosciences, and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

Chirag Patel: Thank you, Tony. Good morning to everyone on the call. Amneal delivered solid financial performance in 2023, as revenues grew 8% and adjusted EBITDA grew 9%. We raised our guidance twice during the year and delivered on it, driven by strong execution and the robust performance across our diversified business. We expect our momentum will continue in 2024 and beyond. Amneal's core strengths lie in our broad-based business platform and our team, both of which are dedicated to providing access to high quality, affordable, essential medicines. Since Chintu and I returned to the company in 2019, we have been implementing a thoughtful and deliberate strategy to transform Amneal into a leading global diversified pharmaceutical company. With a global aging population and ongoing supply challenges and shortages, our capabilities have never been more important and more in need. In our affordable medicines business, which is our Generics segment, we have been building our leadership position since Amneal's inception. We have decades-long reputation for industry-leading innovation, quality, and customer service levels. Our strategy focuses on expanding our portfolio and driving growth with complex high-value products across retail, injectables, and biosimilars. Our affordable medicines business has consistently grown each year since 2019, and we have launched more complex retail and injectable innovations in the United States than anyone else since then. In 2023, we set a new record number of 39 new retail and injectable products launched. In retail market, our commercial portfolio of over 230 medicines is complex and diversified, with less price erosion and more stability. Overall, the US Generics industry appears to have turned the corner after years of higher price erosion, as many recognize the importance of the sector responsible for over 90% of US medicines. In injectables, we have an expanding portfolio, significant capacity, and the capabilities needed to scale this business. We are helping address chronic shortages across hospitals and clinics, and are providing ready-to-use injectables that reduce errors and improve the efficiency of care. The next wave of affordable medicines is biosimilars, which has an estimated $141 billion in branded products facing loss of exclusivity between 2023 and 2027. We successfully entered this new market with over three oncology biosimilars. That performance exceeded our revenue expectations in 2023, driven by an exceptional commercial execution in that first year. In Q4, we also expanded our biosimilars portfolio by adding two more oncology molecules to our pipeline. Given the market growth and importance of biosimilars, this is a key area of strategic focus and investment for Amneal. We look to further build out biosimilars pipeline over time. Internationally, we are expanding our reach. In India, we are building a customized portfolio focused on key local needs. In other geographies, we're actively working with partners to register and commercialize Amneal products. In our specialty branded business, we continue to provide differentiated medicines. We are focused primarily on neurology and endocrinology with our key branded products. In Q4, we expanded with the addition of Ongentys, an adjunctive therapy for Parkinson's. Next, we are so excited about the potential approval and launch of IPX203 this year, which we believe meaningfully advances the standard of care for all Parkinson's patients. In our AvKARE distribution business, which we acquired in 2020, the business has about doubled in size in four years. We're launching new products across three channels, distribution, government, and unit dose. In short, we are starting 2024 with remarkable momentum. We believe our durable broad-based top and bottom-line growth profile is sustainable and accelerating. As Amnealians, we wake up every day thinking about what we can accomplish next. We have more shots on goal than ever before. This includes key medicines and new markets where success represents $100 million or more in potential revenues each. Amneal is on an upward trajectory and we are so excited for what's ahead. I'll now hand it over to my younger brother, Chintu.

Chintu Patel: Thank you. Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family who work hard every day to help make healthy possible. As Chirag mentioned, we are executing well on our strategy to be an innovative global pharmaceuticals company capable of driving sustainable growth in the key areas of medicine. I will touch on how our core competencies in operations and R&D continue to drive our company success. First, Amneal has one of the best service levels in the industry, with quality at the center of everything we do. Our success is driven by our operational excellence, robust supply chain, and great commercial team. We are driving operational efficiencies to lower cost and expand our margins. At Amneal, we have long been focused on global supply chain security and resilience as we work proactively to meet market needs, given the dynamic and ever-changing nature of our business. Over the last few years, we have invested substantial resources to triple our injectables capacity to scale our business and help address market shortages. As you know, the US pharmaceutical market is plagued by chronic drug shortages, including critical oncology therapies. There are several contributing factors, including market price being generally too low for some products to be produced, and contract commitment being too short term in the retail market. As of February, the US FDA listed 121 products in shortages, including 78 injectables, about 20 of our commercial and pipeline injectables products around the US FDA shortage list. We continue to work closely with the FDA to help alleviate drug shortages in the US. We also remain committed to maintaining our stellar quality track record. Since 2005, the US FDA has conducted over 100 successful inspections with either no or only minor observations. Now, all of our manufacturing locations are FDA-approved for commercial products, including our inhalation plant in Ireland. As the standards of quality continue to increase, we continue to invest in quality and infrastructure. Our high-quality global operations are at scale to support sustainable long-term growth. Second, innovation is the lifeblood of any growing pharmaceuticals company, and that's certainly the case for Amneal. In 2023, we launched a record 39 new retail and injectables products. Looking forward, the pipeline is deep, with 160 products pending approval or in development. We have 88 ANDAs pending, of which 64% are non-oral solids, primarily injectables, ophthalmics, and inhalation products. Further, we have 72 pipeline products, of which now 94% are non-oral solids. Accordingly, we expect over 30 new launches in 2024. Also, approximately 45% of pending ANDAs and over 60% of our pipeline are expected to be first to market, first to file, or 505(b)(2) products. As we shift towards complex innovations, we have also been very disciplined by doing more with less spend, and have improved the efficiency of our R&D operations. This also allows us to allocate more investment towards external R&D over time. Our key area of R&D focus remains injectables. In 2023, we launched 40 new injectables, which sets up well for revenue acceleration in 2024 and beyond. We are increasingly focusing our R&D on oncology, ready-to-use bags and long-acting injectables. We look to launch two to three high-value 505(b)(2) injectables each year going forward, starting with the upcoming launch of PEMRYDI RTU in April. In addition, our filing for risperidone was recently accepted by the FDA. We have more products like these in the advanced stage of development. Outside injectables, another complex area we are focusing our R&D effort is inhalation. We are advancing a number of inhalation drug delivery devices, including metered-dose inhalers and respimat products, which we believe will drive sustainable long-term growth. The next key catalyst is Naloxone nasal spray, which is an essential life-saving drug. Our facility in Branchburg, New Jersey, has been repurposed for making this product. Our goal date is soon and we are ready to go. This product will be available over the counter and to States and counties around the US to help improve access to these critical overdose rescue therapy. Next, we are very excited about the future of biosimilars and pleased with the commercial success of our first three products. This is a key area of growth for us and to build on that initial success, we added two more biosimilars to our pipeline in 2023, and we look to add two to three more to our pipeline in 2024. In international, we filed about 60 dossiers in emerging markets in 2023, and we plan to file 150 to 200 more in Europe and the rest of the world in 2024. In specialty, we are continuously evolving our R&D efforts to move up the value chain, just like in Generics. On IPX203, we have completed one additional study with very good results and made our complete response resubmission in early February. We look forward to launching IPX203 in Q3 pending FDA approval. We seek to provide access to IPX203 for the over 10 million global Parkinson's patients, and are pleased to recently sign licensing agreements to bring IPX203 to Europe, Canada, and Latin America. Next, our DHE autoinjector for migraine and cluster headache is set for Q1 2025 launch, as site transfer to Amneal manufacturing is underway now. We continue to look to add to our specialty pipeline, particularly in new key areas of neurology and endocrinology. As Chirag mentioned, our hard work continues in 2024 as we build on the success of 2023 to bring Amneal to new heights. As founders and CEOs, we are extremely passionate about our company's mission and the shared value we can create for all our stakeholders. I will now pass it over to Tasos.

Tasos Konidaris: Thank you, Chintu, and good morning, everyone. As a reminder, the four pillars of value creation at Amneal are diversification, financial growth, cash generation, and deleveraging. I'm extremely pleased with our performance across all four pillars in 2023 and excited about 2024 and beyond. Let me first start with diversification, where Amneal has made remarkable progress, driven by AvKARE, strong cadence of new more complex products, growth of our specialty brands, and expanding in new areas such as biosimilars. As a tangible result, our oral solid Generics now account for 25% of total revenues compared to 53% in 2019. Also, our Generics account for 61% of total revenue compared to 80% in 2019. We expect our diversification to grow over time, which bodes well for consistent financial performance. Let me now discuss our second and third pillars of value creation, where financial performance and cost generation was undoubtedly exceptional in 2023. All business units grew their respective businesses to deliver record levels of financial results, and substantially exceeded every guidance metric we shared with you over the course of last year. Let me first start with our Q4 results, where we recorded strong revenue, $617 million. Generics net revenue was $363 million, down 9% due to year-end timing of orders. Products launched in 2022, 2023 and biosimilars, continue to perform very well and added $34 million in Q4. Q4 specialty net revenue of $104 million grew 2%, driven by key brand products, while AvKARE net revenues of $149 million grew 38%, reflecting strong growth across all of the three customer channels. Q4 adjusted EBITDA of $142 million compares to $154 million in the prior year quarter, driven by investments in R&D and commercial to drive future growth. Adjusted EBITDA in Q4 was ahead of our average quarterly 2023 level, as well as our expectations, which is why we exceeded our annual adjusted EBITDA guidance. Q4 EPS of $0.14 compares to $0.23 in the prior year quarter, mostly driven by higher interest costs. From an operating cashflow perspective, in the fourth quarter of 2023, we generated $136 million compared to negative $23 million in the prior year quarter. The strong growth was well ahead of our expectations and reflects both the strength of our underlying business, as well as timing benefits related to collections of our accounts receivable. Let me now discuss our full-year 2023 performance, where total net revenue grew to a record level of $2.4 billion, up $181 million or 8%. Generics net revenue of $.1471 billion grew 3%. Products launched in 2022, 2023, and biosimilars, added $130 million or 9% of growth. The remaining product portfolio continues to perform well due to the relevancy of our products, strong market demand, and Amneal’s high quality supply chain. Specialty net revenue for the year was $390 million and grew 4%, driven by key branding products. AvKARE net revenue for the year was $532 million and grew 31%, driven by new product launches and strong commercial execution across all its three customer channels. Full-year adjusted EBITDA was $558 million and grew 9%, well ahead of our original 2023 guidance of $500 million to $530 million, as well as the guidance we provided in November, which was between $540 million and $550 million. Our growth was driven by strong operating leverage, favorable R&D spend, and growth in our commercial expenses. Full-year 2023 adjusted EPS of $0.64 declined 6% as higher interest expense offset adjusted EBITDA growth. Nevertheless, our EPS performance, again, substantially exceeded all prior guidance we had provided. Operating cashflow in 2023 was $346 million compared to $65 million in 2022. Our 2023 performance was well ahead of our expectations, and benefited from strong collections in December. It is worth noting that our 2023 operating cashflow of $346 million, also includes $86 million in legal costs, mostly related to the settlement of the Opana ER case. At the end of 2023, we only had one last remaining payment related to Opana IER for approximately $52 million, which bodes well for future cash generation. Let me now turn to our 2024 guidance where we expect another year of strong growth. On the top-line, we expect total company net revenue of $2.550 billion to $2.650 billion, reflecting high single-digit growth driven by robust growth in all of our three segments. First, in Generics, we expect high single-digit growth compared to 3% in 2023 due to three key dynamics. Number one, biosimilars should more than double to over $125 million in 2024 compared to $66 million in 2023. Our three oncology-focused products continue to drive substantial value to both payers and patients. Number two, new product launches, many of which have already been approved and launched, should add over $100 million. In addition, we're optimistic on the potential FDA approval of Naloxone, which could add over $30 million in 2024. Three, as we always do, we expect the competitive nature of Generics to persist and the strength of Amneal’s R&D, superb quality, and reliable supply chain to be competitive advantages. Second, on the specialty business, we expect low double-digit growth compared to 4% in 2023, driven by our key branded products. And in addition, Ongentys in our Parkinson's franchise. We look forward to the potential approval of IPX203, but we have not included any revenues at this point as to ensure proper conservatism. Finally, on AvKARE, we expect double-digit top-line growth, albeit some slowdown from the 31% growth in 2023, driven by continued broad-based trend across all channels and a number of new launches. Moving down the P&L, we expect 2024 adjusted EBITDA of $580 million to $620 million, reflecting continued high single-digit growth and higher investments in R&D to drive the numerous projects in our pipeline. From an adjusted EPS perspective, we expect a range between $0.53 and $0.63, driven by higher interest costs, partially offset by higher adjusted EBITDA. On the cost side, we expect operating cash flow, excluding legal settlements, between $260 million and $300 million. The strong cost generation reflects higher EBITDA, typical accounts receivable collection patterns, and higher interest expense. From a capital expenditure perspective, we expect $60 million to $70 million a year. Finally, we continue to make solid progress on our fourth pillar of value creation, deleveraging. Net leverage has come down remarkably from 7.4x in 2019 to 4.8x at the end of 2023. For 2024, we expect to pay down between $100 million and $200 million of gross debt and reduce net leverage closer to 4x by the end of 2024, below 4x in 2025, and then below 3x soon thereafter. With that, let me turn the call over to Chirag.

Chirag Patel: Thank you, Tasos. In summary, 2023 was a very good year across the board for Amneal. Looking forward, we believe 2024 will be even better as our future is so bright. Let's now open the call for Q&A.

Operator: Thank you. [Operator Instructions] First question comes from Nathan Rich with Goldman Sachs (NYSE: GS ). Your line is open. Please go ahead.

Nathan Rich: Great. Good morning and congrats on the strong year and for all the details that you shared on the call this morning. I wanted to start with the guidance for the specialty segment in 2024. It seems like you're expecting a nice acceleration in growth. I think, Tasos, if I heard you correctly, it doesn't include IPX203. So, could you maybe just talk about what's driving the growth there, how much is maybe coming from Ongentys and adding that into the portfolio? And then bigger picture, could you maybe just talk about the initial feedback of adding Ongentys in, and can you talk about what the commercial strategy will be, assuming IPX203 gets approved later in the year, and how that'll help your market position relative to what the experience has been with Rytary.

Tasos Konidaris: Hi, Nate, I’ll take the first part as to kind of what's driving the accelerated growth, and I think it just really comes across Unithroid just continues to be doing incredibly well, growing at double-digit rates, number one. Rytary, we aligned our field for commercial - our field forces last year. We have a new leader in that market and just continues to drive high single-digit prescription growth. And then finally, as you correctly pointed out, Ongentys. So, this year in 2024, we have a full year of revenues. That should contribute between $25 million to $30 million of incremental revenue. So, it's really kind of driven across all of those three key branded products. And as you mentioned correctly, we don't have - we have not built the - any potential IPX revenues in our guidance. Hopefully, we'll get approval later on this year, and we should be in a position to add those in the latter part of the year.

Chirag Patel: Yes, and Nate, this is Chirag. Just taking it further, how Ongentys has worked out really well for us. It's a comp inhibitor. It's complementary with CD/LD. It improves the off time for certain patients. So, excellent start of transitioning the product from Neurocrine (NASDAQ: NBIX ) to us and a great partnership with BIAL, the Portuguese innovative company. And the sales force already relaunched at Amneal last week, and very excited to complement Ongentys with currently Rytary, and going forward with IPX203. IPX203, we're also ready to launch, and as you know, that's completely differentiated product, then Rytary and obviously much better than the IR with the 1.55 hours of good on-time per dose, which is significant. And 95% of Parkinson's patients still take IR product. Only 5% are on Rytary. So, we're going on a broad-based strategy to general neurologists. We have target lists. We've been in contact with payers for a while now, and we're ready to have a successful launch. With all the learnings of last seven years with Rytary, our teams are very excited and we expect the conversion of these IR to IPX203 and complementing with Ongentys to be a much higher percentages than Rytary. And globally also, as my brother mentioned, we have licensed out the products in Europe, in South America, in Canada, soon to be in China, Japan, India. India we’ll be marketing by ourselves. So, Parkinson's patients globally should be using latest and greatest formulation and technology and have a better life every day than use 35, 40 years old technology of IR and go through the ups and downs of daily life, and it helps their caretakers as well. So, very excited on specialty growth. And then it continues in 2025 with DHE auto injector launch and more to come after that.

Nathan Rich: Great. And then maybe just a kind of higher-level question. Looking at the guidance for this year, top-line came in stronger. I think margins are going to be pretty consistent year-over-year, maybe down slightly. I guess I'd just be curious, as we think about the view kind of three to five years out, how do you see the margin profile of the business evolving as you bring a lot of these new products to market? And once we start to see that, especially on the specialty side, do you - I would just be curious to get your view on where you think margins for the business can go longer-term. Thank you.

Tasos Konidaris: Yes, I can take that. As you said, margins have been pretty consistent, number one, the last few years. So, and what we've been able to do is really focus on incremental revenues, on incremental EBITDA, right, and transition the business to a more complex, more durable cash-generating business. So, our focus has been primarily on driving incremental top-line, bottom-line and cash. Over the course of time, our profitability profile should increase. It’ll increase for a couple of reasons. Number one is, as our generics portfolio continues to evolve into the world of the more complex businesses, right, those businesses have higher levels of profitability, number one. The same thing, over the last couple of years, in 2024, on the specialty side, we continue to build out those infrastructures, those costs will be behind us. So, over the course of time, when you look at the EBITDA profile and the gross margin profile, should continue to grow over time.

Chirag Patel: And just to add, Nathan, our injectable plants are underutilized as we are launching new products. So, in coming years, both our new injectable facilities will be totally utilized, plus our inhalation plant in Europe, where we don't have a commercial product, we expect to have a launch by end of the year, early next year. I think that will also improve the margin. So, I think as Tasos mentioned many, many complex product and the plan to do utilization in certain complex area will improve the margins in coming years.

Tasos Konidaris: Yes. And more specialty revenues as well.

Nathan Rich: Great. That's helpful. Thanks very much.

Operator: We now turn to David Amsellem with Piper Sandler. Your line is open. Please go ahead.

David Amsellem: Hey, thanks. Good morning. So, a couple of questions. First on 203, can you just talk about the payer landscape and how that is going to evolve, bearing in mind that we'll see generics for Rytary. So, just talk about what you think are going to be the challenges here regarding access. That's number one. Then secondly on injectables, can you just talk about how much contribution from shortage products you're going to be getting, not just this year, but longer term and how big of a priority is it to focus on the range of different shortage products that we're seeing? And what is the priority vis-à-vis more complex injectable products that you're developing? So, if you could talk to that, that would be helpful. Thank you.

Chirag Patel: Thank you, David. I'll take the first one and hand it off to Harsher, who is head of our institutional business and biosimilar business, to answer the injectable products question. So, IPX203 coverage, the initial discussions, which is going back to last year, has been very positive. Our entire strategy on pricing with keeping the excess in mind because we want to reach more neurologists, more patients, has been extremely positive. I do not know if you know, but Rytary has the best payer coverage among the class. It's 80% is covered, which we expect the similar coverage for IPX203. So, we're very positive on the coverage, which we're under initial discussions and we should be - it should be coming online upon approval as well as a few months after that.

Chintu Patel: Just to add on IPX, that Rytary only covers 5% of the patient, and IPX is a very unique formulation, which will have a broader reach. So, I think when the generics of Rytary comes, we don't believe that will have much of a bearing on IPX adaption because it's very unique, much more stable formulation in a way that it provides long-term blood concentration, good on-time, 1.55 hours. So, I think it's a distinctly different product than Rotary. So, we are very excited on the offering for the Parkinson's patients. And we'll continue to continue to conduct further studies. As soon as approval comes, we're conducting more studies on IPX203. I'll pass it on to injectables, and then, David, if you have any follow up, we’ll …

Harsher Singh: David, with regard to injectables, this is Harsher, look, it's hard to give you an actual number that breaks up steady products versus shortage products. What I will say is the strategy here is to support the market in areas where the market fails in order to build franchises that are sustainable. And you can see in our history, there is a product readily available called methylprednisolone acetate, where we effectively did that, where we went from about 2% share to 50% share, and then retained that share even after other competitors returned to market by creating a franchise. And I think that's what we look to do with our diversified manufacturing base that allows us to rapidly scale up and support markets where there are structural failures. We expect to see more of those failures in the coming months, and I think the market is ripe for solutions like those that we provide.

Chirag Patel: And our capacity has been tripled from 20 million to 60 million units per year. So, that allows us to address more shortages. And what we are building out is especially addressing oncology shortages and how can we be helpful for the clinics and the hospitals to bring more of those products, and consistently provide them.

Chintu Patel: David, on a priority in development, our priority is always the complex injectable product. So, we continue to focus on complex because those are much more higher barriers to entry, but we do have shortage products and with expanded capacity, we can cater to the market and provide those products.

David Amsellem: Okay. That's very helpful color. Just a quick follow up and I'm sorry if I missed this. Are you right-sized on injectable capacity? Are you planning more capacity expansion?

Chirag Patel: Right now we have what we need.

David Amsellem: Okay. Helpful. Thank you.

Operator: We now turn to Balaji Prasad with Barclays (LON: BARC ). Your line is open. Please go ahead.

Balaji Prasad: All right, good morning, everyone, and congratulations on the performance and also the strong guidance that you have provided. So, starting on the guidance, on the key launches that you're expecting for 2024, or at least some of the ones immediately look like they’re set to contribute $100 million to $130 million. I want to see if there are any gating factors like inspections that are had to be concluded for any of these launches and are not. so, kind of frank, just the risk levels for these launches. And maybe secondly on the launch timeframe for both Denosumab, Naloxone I heard that you have launched recently. Can you also comment on the pushes and pulls towards the market share and the total number of units that are potentially there in this market? Thank you. That's one. Two, on guidance, again, 2024 strong EBITDA guidance. Extension of the previous question, how would these new launches impact the guidance in either direction, or is this current guidance based mostly on products that you launched in 2023 and would gain traction in 2024? Thanks.

Chintu Patel: Yes, Balaji, this is Chintu. So, I'll answer the first one. You know Amneal has a standard quality track record, over 100 inspections over the last 20 years. And all of our plans are FDA-approved, including our inhalation. So, for all (indiscernible), we don't anticipate any PAI as of now because we had recent inspections of all the plant, like our Naloxone facility, our injectable plant. So, I don't think there is any gating factor that's going to prevent the approval of those products in 2024. On Denosumab, our launch is 2025, 2026.

Chirag Patel: Yes. So, guidance, the key launch is - we launched 39 products. So, about 20 plus was launched in the fourth quarter 2024. So, those get annualized. So, revenue is already there approved. We feel good. Naloxone is the new - FML was - we just launched in January. Naloxone's coming soon, with a potential of quite a bit this year and a lot more in 2024, I mean, 2025, 2026. Plus we expect a couple of big GX launches as well, which we haven't disclosed, which is coming up in May, June timeframe, July timeframe. So, very excited on the complex product launches. Obviously, the Naloxone annualizing the last year launches, which includes injectable launches. So, several injectable launches would be annualized as well. So, that is how the launches shape up. And we feel very comfortable with push and pulls. And since having multiple launches, that should not be any problem.

Balaji Prasad: And on the guidance?

Tasos Konidaris: I figured that was - the guys did a pretty good job addressing it. There is nothing inherently risk here in our guidance this year than last year, Balaji. So, in prior years, our EBITDA tended to be more backend loaded, which typically investors don't love. Our guidance this year is more evenly split throughout the year. So, we're not planning any huge ramp up towards the backend of the year. And there are just different levels, different products, and it's not just the revenue we're accounting at. It's also the operating expenses. So, we continue to drive a number of operating expense efficiencies here. So, if something were to happen on any product, which always happens, by the way, right, if something were to happen on the revenue side, we're just looking to pull all the levers in the operating expense side to protect the bottom line. So, hopefully this kind of gives you enough insight.

Chirag Patel: Yes, Balaji, we feel much better this year than we felt same time last year.

Balaji Prasad: Great. Thank you. Maybe a quick follow up. Chirag, In your comments, you spoke about the US generic industry having turned a corner after years of price erosion. It's a call we've been making, and good to see that being validated across the board. I want to understand if there's going to be additional competitive maneuvers from the buy side, or is there a equilibrium that is being reached now between the manufacturers and the buy side? Thanks.

Chirag Patel: Balaji, it's still work in progress. We are seeing good signs, and most importantly, it is causing shortages, and it could cause further shortages. So, FDA is really worried. As you can see, the Congress constantly putting out hearings and white House meetings, which our team attends as well. This is a real problem. If we - it has to get better. Six years of massive price erosion, nobody can invest in quality. Nobody can invest in a proper infrastructure, new machineries. So, all these constant dialogues and us being a leading company, obviously we're forefront of those dialogues with our esteem partners. And it's been a good change. We're in a - more on a long-term stability programs with one of our largest buyers. Another big retailer is moving in the same direction. So, we're very hopeful for what we are seeing because it is just not right to have prices from manufacturers, which are pennies or below pennies. It just doesn't - nobody can even supply. Nobody can even invest, and it'll cause quality issues and shortages. And I'm afraid that if consumer starts knowing that the pill they're taking is being made or sold for one penny, it may have a very negative placebo impact.

Balaji Prasad: Thanks, Chirag.

Operator: Now I'll turn to Chris Schott (ETR: 1SXP ) with J.P. Morgan. Your line is open. Please go ahead.

Chris Schott: Great. Thanks so much. Just a couple here. I guess first on the generic Avastin dynamics, just elaborate a little bit more in terms of what you think has allowed Amneal to take share and succeed in this market the way you have. And just any learnings, I guess, from these first three launches that's informing, I guess, the type of assets that you're considering and how aggressively you're kind of looking at the biosimilar market as a whole. And then my second question was just to follow up on IPX203. I know you're not including sales in the guidance this year for conservatism, but it sounds like you expect coverage to come on board fairly quickly, post-approval. So this is the question, do you expect payer dynamics will be a limiting factor at all early in the launch, or is this a product that we should expect could roll up and ramp pretty quickly post-approval? Thanks so much.

Chirag Patel: Great. So, Chris, how are you? Let me turn over to Harsher first for Avastin and how we are building the Onco franchise, and then I'll take on the overall biosimilar markets as well as IPX.

Harsher Singh: Chris, thank you for your question. As we look at Avastin and our oncology/biosimilar franchise as a whole, what we recognize is that the marketplace is challenged by pricing dynamics that are not consistent with the expectations. And what we were able to deliver was a solution that effectively met the needs of the market in a marketplace that had become challenging for some of those particularly providers, but also payers. And by learning a little bit from the dynamics that we'd seen in the past and putting forward a solution that we felt addressed those, we were able to create what is a fairly stable pricing dynamic and fairly stable uplift that looks like it improves Q-over-Q. We think that that is a repeatable business model, and we think that is a business model where our relationships and our longevity and our ability to do it time and again, which is going to differentiate us, which is why we continue to look at oncology, and you'll see us launching products like PEMRYDI, which we expect to launch next quarter.

Chirag Patel: Thank you, Harsher. And overall, biosimilar market is going to be large over next several years, and it becomes more healthier and healthier as new launches come in. It is going to be competitive. So, you have to be mindful on the investments, and you have to select which product you want to enter in. Our strategy has been more buy and bill or combination of buy and bill and PBM-driven, and we’ll continue to invest in those assets. Currently, we are only front-end commercial for United States. As over time we can integrate for potentially or partner more strategically, so all those avenues are open for us, but we are committed to biosimilar business. We believe it'll be a size of - global size of about $80 billion to $100 billion by 2031, 2032, for the manufacturers. So, that is a fantastic market for a company like us who is completely focused on affordable medicines as we lead the retail segments, pretty soon to be leading injectable segments. And now here comes the biosimilar segments, and we intend to lead and especially in the United States. IPX203, that's good news. We expect the coverage to be right away as well as the uptake to be right away because of our experience with Rytary, the relationship with (QLs), relationship with foundations. The patients’ caretakers have started building relationship with 700 neurologists, which we never reached out before. And the purpose of IPX203, having a great market access team, MSL teams, the sales team, which have relationship over last seven to eight years, we're very excited. It's a strong uptake and shouldn't take - it's not a new molecule that should take a longer time for going to the peak sales. So, excited about IPX203. Thank you.

Chris Schott: Thank you.

Operator: Our final question comes from Leszek Sulewski with Truist Securities. Your line is open. Please go ahead.

Leszek Sulewski: Good morning. Thank you for taking my questions. I have two just a quick follow up on Ongentys. So, taking the early performance trends of Ongentys into consideration, do you envision treating this product as a essential product relaunch? And how do you think the peak sales potential is for the product now that it's on your platform? And then second, you highlighted focus on neurology and endocrinology to grow your branded portfolio. What opportunities do you see out there within these two therapeutic areas, and potentially outside to add to your specialty segment, and also I guess high level, how are you thinking about other chunkier BD plans? Thank you.

Chirag Patel: Yes. Hi, Les. So, Ongentys, Neurocrine had done a good job with taking that continuous platform, and it has been a smooth transition. So, we thank Neurocrine team as well. And we are now expanding the reach and the message on a complementary outcome between the Ongentys, which is a comp inhibitor, which extends the life of levodopa, therefore reducing the off time. So, it's a classic complementary products between the - where soon to be IPX203, currently Rytary, and then with comp inhibitor, which is Ongentys. So, we expect the peak sales to keep going up. We haven't been public, but should cross the $50 million and keep going. And then on the pipeline for in neurology, we are looking at different assets, whether they're in phase two, phase three, and we'll be probably announcing certain deals this year, we're hopeful, and that would be more expanded pipeline that we are now going after the products that can generate similar to IPX203, $300 million to $500 million in revenue. So, we're not looking at smaller assets anymore. And on endocrinology, we have our K-114, which we're very excited if we can get through the regulatory hurdles. It's the much-needed products in the market with the combination with the T3 and T4. We believe that product also can be a pretty large contributor, and also looking at a couple of pipeline assets in their phase two and three in endo as well.

Leszek Sulewski: Thank you.

Operator: This concludes our Q&A. I hand back to Chirag Patel for final remarks.

Chirag Patel: Well, first, thank you to the global Amneal family for very strong performance in 2023. And our mission is clear, and it hasn't changed since our founding, provide access to high quality, affordable, and essential medicines. We’re building momentum across our diversified pharma business. We believe 2024 will be even better as we continue to grow, expand our reach, and impact more patients than even before. Thank you very much.

Operator: Ladies and gentlemen, today’s call has now concluded. We’d like to thank you for your participation. You may now disconnect your lines.

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