Amneal Pharmaceuticals, Inc. (NYSE: NASDAQ:AMRX) has reported a remarkable performance in the first quarter of 2024, with a significant 18% increase in revenues compared to the previous year, achieving a record $659 million. This growth was fueled by double-digit increases across all segments—Generics, Specialty, and AvKARE.
The company's strategic endeavors, including international expansion and a focus on addressing drug shortages, have positioned it for sustainable growth. Amneal's commitment to innovation is evident in its robust pipeline, with over 30 product launches planned for the year and a strong presence in the biosimilars market, anticipating revenues of over $125 million in this sector for 2024.
Key Takeaways
- Amneal Pharmaceuticals' Q1 2024 revenues hit a record $659 million, an 18% year-over-year increase.
- All three business segments experienced double-digit growth, with a strategic focus on affordable, high-quality medicines.
- The company is expanding its global footprint, particularly in India, and is addressing healthcare needs in various markets.
- Amneal has tripled its injectables manufacturing capacity and has a strong pipeline with over 30 new products set to launch this year.
- The company expects substantial revenues from its biosimilars market and has in-licensed biosimilar candidates for Prolia and XGEVA.
- Adjusted EBITDA for Q1 stood at $152 million, up 31%, with a full-year outlook targeting the upper end of $580 million to $620 million.
Company Outlook
- Amneal aims for total net revenue between $2.550 billion and $2.650 billion for the full year.
- The company plans to launch one to two specialty products annually, with a strong focus on R&D.
Bearish Highlights
- The timing of new product launches and approvals, which are significant growth drivers, is not entirely within the company's control.
Bullish Highlights
- The company has experienced a 20% increase in new patients for its brand products.
- Six key products have received approval, and the company anticipates good market penetration for its biosimilars Prolia and XGEVA, expected to launch in 2026.
Misses
- Specific details about their Para IV on XIFAXAN or their Restasis launch timeline were not disclosed.
Q&A Highlights
- The company has contracts with CVS and Walgreens and expects significant opportunities, particularly in the government sector, for its naloxone product.
- Amneal is open to strategic options for AvKARE, suggesting a potential transaction if the right price is offered.
- There is anticipation for the launch of IPX203, a novel formulation for Parkinson's disease, with expected peak revenues of $300 million to $500 million, targeting a substantial market share.
Amneal Pharmaceuticals continues to demonstrate strong momentum and a clear strategic vision as it capitalizes on growth opportunities within the pharmaceutical industry. With a diverse portfolio and a commitment to addressing healthcare needs both domestically and internationally, Amneal is well-positioned to maintain its trajectory of sustainable growth and innovation.
InvestingPro Insights
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has not only impressed with its Q1 2024 performance but also presents an interesting profile when considering the InvestingPro data and tips. Here are some key insights that may be relevant to investors:
InvestingPro Data:
- The company's market capitalization stands at $2.09 billion, reflecting its size and relevance in the pharmaceutical industry.
- With a Price to Earnings (P/E) ratio of -14.13, Amneal is currently not profitable; however, the adjusted P/E ratio for the last twelve months as of Q4 2023 is 59.67, indicating expectations of future profitability.
- Revenue growth for the last twelve months as of Q4 2023 is reported at 8.2%, showcasing the company's capacity to increase its sales in a competitive market.
InvestingPro Tips:
- Analysts have revised their earnings estimates downwards for the upcoming period, suggesting that investors should keep an eye on future earnings reports to assess the company's performance against these expectations.
- Despite not being profitable over the last twelve months, analysts predict that Amneal will turn a profit this year, which could be a sign of the company's improving financial health and a potential catalyst for the stock price.
For investors looking to delve deeper into Amneal's financial health and future prospects, there are additional InvestingPro Tips available on https://www.investing.com/pro/AMRX. These tips provide a comprehensive analysis that could aid in making informed investment decisions. Remember to use the coupon code PRONEWS24 for an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are 9 more InvestingPro Tips listed in InvestingPro, offering a broad spectrum of insights into Amneal's financial and market performance.
Full transcript - Amneal Pharmaceuticals Inc (AMRX) Q1 2024:
Operator: Good morning and welcome to Amneal Pharmaceuticals First Quarter 2024 Earnings Call. I will 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 first quarter 2024 earnings call. Today, we issued a press release reporting Q1 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 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: Thank you, Tony. Good morning to everyone. Our first quarter performance was outstanding. Record Q1 revenues of $659 million grew 18%. For the first time, all three of our segments generated double-digit growth in the same quarter. Q1 adjusted EBITDA of $152 million grew by 31% as strong execution continues to drive sustainably higher levels of profits. As momentum builds across Amneal, we are confident in our ability to achieve our financial commitments for 2024 and beyond. Our strategic vision for Amneal is to be a global, diversified pharmaceutical company that provides patients, providers, and payers with access to high quality, affordable, and essential medicines. In the United States, Amneal fills approximately 175 million prescriptions per year. In retail pharmacies, we provide complex genetics medicines such as transdermals, topicals, oral solids, and ophthalmics. For hospitals and clinics, we supply important acute care injectables where there are chronic shortages. In biosimilars, we are expanding access to oncology therapies and adding more to our portfolio. In Specialty, our innovative medicines advance the standard of care, such as in Parkinson's disease. In our AvKARE distribution business, we provide military veterans with access to high quality medicines. Globally, we are addressing unmet health care needs in developing and developed countries. As we continue to grow larger, Amneal is leading a new era of affordable medicines and having a significant societal impact. Nowhere in our commitment to this mission more evident than our recent approval of naloxone. Opioid overdose remains a US public health care emergency. We are expanding access to this critical rescue medicine as an OTC product at pharmacies and for the public interest through states and cities across the United States. We were pleased to finalize our partnership with the State of California with more to come. We are so proud that this essential life-saving medicine is made in America and manufactured here in New Jersey by Amneal. Let me now walk through our business at a high level where we remain confident in our strategy, our ability to execute well and drive growth, and the opportunity to have a tremendous impact. First, our affordable medicines business, which is our Generics segment, has consistently grown each year since 2019. We are seeing this growth accelerate in 2024, driven by our diverse portfolio of retail, injectables, and biosimilars. Amneal has a track record of quality, innovation, and customer service. Those hallmarks continue to resonate in the US pharmaceutical market, plagued by supply shortages with perpetual demand for high quality medicines. The durability of our complex portfolio and regular cadence of new launches each year position Amneal well to continue expanding our leadership position in affordable medicines and driving sustainable long term growth. In the retail pharmaceutical market, our portfolio of around 240 medicines is complex and diversified. With industry-wide supply chain disruption due to site inspections and manufacturer discontinuations, price erosion in the United States generic industry remains lower than it has been in several years. In injectables, we are expanding our portfolio and have a significant capacity to help address drug shortages in hospitals and clinics. Our injectable strategy focuses on providing unique, ready to use products like our recent launch of PEMRYDI RTU for the treatment of certain lung cancers. Across retail and injectables, we are on track to launch over 30 new products this year, following our record 39 new launches last year. In biosimilars, we are seeing the next wave of affordable medicines. From 2024 to 2028, an estimated $192 billion in annual branded biologics value will lose exclusivity. We expect most biosimilar markets to be less competitive, given the inherent complexities of these molecules and the investment required to bring them to market. Adoption rates for early biosimilars are now 80%, particularly in oncology where we operate. Our excellent commercial team is driving strong adoption at both community oncology and hospital integrated delivery networks. That, coupled with our pipeline and with trusted partners, gives us confidence in continued momentum. We are well on our way to achieving over $125 million of revenue in 2024, with $90 million in biosimilars revenue over the last 12 months. We look to in-license one to two biosimilars each year or more and to be vertically integrated over time. Internationally, we are continuing to expand our reach and build a strong foundation. This is happening most notably in India, where we are building a customized portfolio of therapies for unmet needs like critical care, ophthalmology, oncology and diagnostics. In other geographies, we are working with partners to register and commercialize select and new products. We expect international expansion will add $5,200 million revenues by 2027 and rapidly scale up to that. Next, in our Specialty business, we continue to make good progress with our key neurology and endocrinology branded products, as revenues are growing double digits. In Q1, we successfully launched Ongentys, an adjunctive therapy for Parkinson's disease, which we recently in-licensed to our specialty portfolio. Next up is IPX203, with our action date is on August 7. Carbidopa/levodopa has been the main therapy for Parkinson's disease for over five decades. We believe IPX203 meaningfully advances that standard of care with a broad application for all patients. In our AvKARE distribution business, we have more than doubled revenues and profits since our acquisition in 2020. We are expanding all three channels, distribution, government and unit dose, driven by new products from suppliers, including Amneal. We now expect over $650 million in our AvKARE revenue next year, as we expect this to remain a high growth business. In short, we're starting 2024 with very strong momentum. Our diversified growth profile is sustainable and our financial performance is accelerating remarkably. I'll now hand it to Chintu.
Chintu Patel: Good morning, everyone. Thank you, Chirag, and thank you to the global Amneal family who works hard every day to help make healthy possible. I will discuss how our core strengths in both operations and innovation provides us with a long runway for sustainable top and bottom line growth. First, quality has been at the center of everything we do since our founding in 2002. We continue to invest in quality through automation and AI technologies to advance our global infrastructure. Our success is also driven by our commitment to operational excellence, ongoing efficiency programs and a robust supply chain. All of our plans are FDA approved. In each plant, we are driving optimization and efficiency programs to maintain our exceptional customer service levels and gain cost efficiencies. Across our supply chain, we are focused on what we call the three Rs – redundancy, resiliency and reliability. In particular, drug shortages are an ongoing challenge in the market. The US FDA released 114 drug shortages, including 75 injectables. At Amneal, we look to be part of the solution. We have about 20 commercial and pipeline injectables that are on the shortage list, including oncology medicines. We have also tripled our injectables manufacturing capacity in recent years at multiple plants. We continue to prioritize efforts to help alleviate shortages in the market, particularly for injectables. Second, our track record in innovation is very strong, and we are off to a great start in 2024 with five key complex product launches, naloxone nasal spray, PEMRYDI RTU, carvedilol ER, FML eye drops, and generic Ciprodex. We currently have 86 new products, ANDAs pending, of which 63 are non-oral solids. In addition, we have 67 pipeline products, 94% of which are non-oral solids. With our ongoing shift towards complex innovations, we have improved our R&D efficiencies and are spending less internally, which allows us to allocate more investment towards external R&D over time. We were so proud of last week's approval of Naloxone nasal spray, a life-saving treatment for drug overdoses. This is a tremendous milestone for the entire team at Amneal. The product is now available through retail pharmacies as an OTC product and to states and counties across the US. We have built robust manufacturing capacity to make up to 10 million two-packs starting next year. We are significantly expanding access to help address the opioid crisis that impacts so many Americans. In injectables, we expect to launch over 10 new products this year, following the 14 new injectables we launched in 2023. Our R&D focus is on oncology, ready-to-use bags, and long-acting injectables. For years, we have been meeting with clinicians to understand their needs. This emphasis on the voice of the customer has allowed us to develop unique presentations of existing products. Last month, we launched our first 505(b)(2) injectable in PEMRYDI RTU. This new ready-to-use presentation of a frequently used oncology medicine can improve efficiency and reduce medication error. We look to launch two to three 505(b)(2) injectables each year with approximately 15 in development. Next, biosimilars continue to be a key area of strategic focus. Building on the success of our first three commercial products, we in-licensed two denosumab biosimilar candidates for Prolia and XGEVA in Q4. Those programs continue to progress with our development partner, mAbxience. In addition, we are pleased to share that, in Q1, we in-licensed two additional pegfilgrastim pipeline programs, on-body injector and pre-filled auto-injector. Today, approximately 30% to 40% of the pegfilgrastim market is on-body and fewer competitors are expected in this space. In total, we have three commercial biosimilars and four more under development, all in oncology. As we establish Amneal as a key biosimilar player, we look to add more opportunistic biosimilar molecules to our pipeline over time. Internationally, we have distribution partners in place for approximately 40 emerging market countries including strong markets like Saudi Arabia, Mexico, South Africa, and the Philippines. We are registering products globally, including in Europe, Canada, China, and emerging markets. In specialty, we are continuously evolving our R&D efforts to move up the value chain. First, our IPX203 complete response resubmission is under review. Also, we are advancing our DHE auto-injector program for migraine and cluster headache. We transfer production internally and are excited to complete our application later this year, which puts us in a good position to launch in the first half of next year, once approved. In addition, we continue to advance our pipeline with K-114 for endocrinology and other programs. We look to launch one to two specialty products each year going forward. Overall, Amneal is expanding and growing in the key areas of medicine, complex generics, injectables, biosimilars, international distribution and specialty branding. We are so deeply passionate about our company's mission and purpose and the good work that remains ahead. I will now pass it over to Tasos.
Tasos Konidaris: Thank you, Chintu. And good morning. At a high level, our diversified business is driving sustainable higher levels of revenues and profits and continued deleveraging. Our first quarter results were excellent with total net revenue of $659 million, up 18%. Q1 generics net revenue of $391 million grew 14%, driven by our diverse portfolio of complex products. Biosimilars generated $27 million in revenue, driven by ALYMSYS. New products launched in 2023 and 2024 added $19 million to Q1 revenue growth. In addition, the remaining base portfolio continued to grow due to the relevancy of our products, strong market demand, less pricing pressure and Amneal's high quality supply chain. Q1 Specialty net revenues of $105 million grew 15%, driven by double-digit growth of our key branded products, plus the recent launch of ONGENTYS in March. Q1 AvKARE net revenues of $163 million grew 33%, reflecting continued strong growth across all three customer channels, driven by new products. Our Q1 adjusted gross margins of 42% increased 250 basis points year-over-year and were ahead of our expectations. Strong gross margins were driven by the favorable mix of revenues that reflected the complexity of our portfolio combined with higher fixed overhead absorption. Q1 adjusted EBITDA of $152 million grew 31%, reflecting robust revenue growth, higher gross margins, tight management of operating expenses and a favorable comparison to prior year. Our leveraged growth profile in Q1 is a blueprint for sustainable higher P&L results for the company going forward. Q1 adjusted EPS of $0.14 grew 17%, driven by higher adjusted EBITDA, partially offset by interest costs. As a reminder, we have made substantial progress over the last four years driving accelerated top and bottom line growth, reducing leverage and resolving legacy matters. As a result, our annual adjusted EBITDA has increased from $339 million in 2019 to $594 million over the last 12 months ended Q1 2024. Also, net leverage has declined from 7.4 times in 2019 to 4.6 times now. As I mentioned earlier, settling legacy legal matters has been a priority of ours. Two years ago, we settled upon our ER litigation and we just made our final payment in Q1. In addition, today, we announced that we reached agreement in principle for a nationwide opioid settlement payable over 10 years that resolves substantially all opioid litigation. Accordingly, in the first quarter, we recorded a pre-tax charge of $94 million, which reflects cash payments in the supply of naloxone nasal spray bought over the next 10 years. As a result, we have now substantially resolved these two legacy legal matters, which removes these overhangs from the company. Given the strong start of the year and our improved visibility, including the recent naloxone approval, we're targeting the higher end of our full year outlook. As a reminder, we expect total net revenue of $2.550 billion to $2.650 billion and adjusted EBITDA of $580 million to $620 million, which reflects high-single-digit growth on both top and bottom line. With that, let me turn the call over to Chirag.
Chirag Patel: Thank you, Tasos. Amneal's Q1 performance was excellent across the board and reflects our continued upward trajectory in driving higher financial results over the years. We are so excited about the opportunities ahead. Let's now open the call for Q&A, Anthony.
Operator: [Operator Instructions]. Our first question is from Nathan Rich with Goldman Sachs.
Nathan Rich: Congratulations on a strong quarter. I maybe wanted to start with naloxone and specifically the California contract. Can you talk about when that contract starts and how long it is and any details you can share maybe on the type of volume commitment that the state made? Have you gotten additional interest from other states sort of on the back of that? Any comments on the margin profile of Naloxone maybe relative to the corporate average would be helpful.
Chirag Patel: California supply starts now and will see the increased demand as they ramp up our label. According to the state's press release, they could buy up to 3.2 million units per year. We don't expect them to buy that in the first year. They'll ramp it up as they go. So, somewhere between, we expect, 2 million to 3 million units in the State of California. The remaining contractual terms are confidential. It was a great win for us and we're very proud of the agreement with the State of California and trusting us to supply and valuing the made-in-the-United States product. So we really appreciate it. In terms of the margin profile, it is going to be higher and accretive than the current gross margins.
Chintu Patel: It's obviously not just the issue of the State of California. It's an issue across all our states and our commercial teams are actively engaged with other internal parties, both on the state and federal level. So really excited to kind of fill the incremental need that's going to provide for many years.
Chirag Patel: Yes. And we have built the capacity to supply 10 million units – up to 10 million units starting early next year. This year, we're producing somewhere between 2.5 million to 3 million units.
Nathan Rich: Maybe just a follow up on the cadence of earnings this year. Tasos, I know you kind of pointed to the high end of the range, but I think looking at the historical EBITDA cadence, I think 20% comes in the first quarter typically. Based on what you did this year, that would imply a number well above that kind of high end of the range. So, is there anything to kind of note on just earnings cadence this year that would be different than normal?
Tasos Konidaris: You take one quarter, you can never annualize this. So if you think about we finished the year last year with EBITDA of, what, $554 million, right? So we added Q1, so our run rate, right, the last run rate of the last four quarters now, it's almost $600 million, $594 million. So the year is playing out how we were hoping it would, which is acceleration of top and bottom line growth, right? So we're having some great, great improvement. So now we're targeting the high end of the range and you're saying, is there more, right? And you can count on us to try to maximize the performance. But at the same time, right, we're also focused on driving and making investments primarily now at R&D, primarily kind of tuck-in licensing deals, the biosimilar and complex drugs to not just maximize this year or the next, but build a long term growth for 2026, 2027. So you're not missing anything. The only thing we're going to be mindful is we want to make sure we have room in our operating expenses to make investments over the next, call it, nine months, primarily in R&D. And then also, depending how things play out with IPX203, kind of making sure we kind of make the right investments there to drive that growth as quickly as possible.
Operator: The next question is from Leszek Sulewski with Truist Securities.
Leszek Sulewski: Can you just provide some initial update commentary on ONGENTYS, given the new ownership structure, perhaps some feedback from prescribers? And then also on PEMRYDI? And I had a follow-up.
Chirag Patel: We're turning it over to Mr. Joe Renda here.
Joe Renda: So far, we've been very pleased with ONGENTYS, as well as the partnership with BIAL. It's been a great partnership, and we've been working very closely with them and their global team, executing upon the strategies that they've learned from over the years. I would say probably the three pieces of feedback that would be significant would be, one, we are hearing very positive feedback from prescribers. There was a concern that ONGENTYS would not be remaining in the market, so prescribers were very pleased when they heard we were going to be taking over this brand. And we've been able to sign on a few more contracts from an access standpoint. So our goal there is to increase the access, the market access that is, for ONGENTYS in the market beyond what it was. And so far, we've been very pleased with that performance and progress. And finally, I would say one of the things we're looking at closely to kind of determine the uptick is what our NBRx performance has been, new patients to brand. And we're up some 20% in NBRxs from a performance standpoint. So far, we're very pleased, and it's been a great partnership, and it's also been a really good augmentation to Rytary.
Chirag Patel: Les, you had a question on the PEMRYDI RTU. The way to think about that for Amneal, right, it's another complex innovation. On the injectable side, it's our first 505(b)(2) launch. We'll do two to three a year going forward. And it's a ready-to-use oncology therapy that reduces steps. So think of it as a new factor of growth for the company.
Leszek Sulewski: Now, moving on to IPX203 and with your action date circled for August 7th, can you just talk about perhaps your launch readiness, your plans with the sales force, and just overall impact potential guidance, if any?
Joe Renda: Les, first of all, I would say one of the things that is significant for us is we've really become a leader in the Parkinson's space. Rytary has enabled us to develop and deepen relationships with key prescribers and movement disorder specialists across the country, really around the world for that matter. And that also is coupled with the fact that we've developed a market access capability that has created an access stream for Rytary that's the best in the Parkinson's community. So we enjoy some 70% commercial coverage and about 60 or so percent of the Part D coverage. The ONGENTYS that I just spoke to has enabled us to actually increase our prescriber base. So we're going deeper now into general neurologists. So when you look at our go-to-market strategy with IPX, the three components there are, one, leveraging and working off of those deep relationships that we've built over the last decade in the Parkinson's community. And then second is to leverage that market access capability that we have. We'll use that same strategy to gain access for IPX203, comparable to what we have with Rytary. Finally, I would say that the novel formulation that is IPX203 really offers greater efficacy, better on time, fewer dosing. So the Parkinson's community itself is very excited. In fact, just last night, we were at a Parkinson's Foundation gala and there was a lot of buzz and talk about when IPX203 is coming to market. So we're very ready and eager to get IPX203 to the hands of the patients that need it out there.
Chirag Patel: Les, in terms of potential of peak revenues assuming approval. We continue to feel great about it. So the number that we – Rytary right now, there's a couple hundred million dollars in annual revenues, right? The guidance we have given about IPX203 is peak revenues of $300 million to $500 million. We think based on the product profile and the fact that IPX203 is only being used by about 5% of the available patients – Rytary, I'm sorry. So there is a tremendous market opportunity out there for the remaining 95% of the market that's not been utilizing Rytary. And I think our peak year revenue is $300 million to $500 million. I think it's just well within what the team is capable.
Operator: The next question is from David Amsellem with Piper Sandler.
David Amsellem: Just have a few questions. Wanted to drill down on the $100 million plus in new product revenue in 2024. Can you talk about the mix between retail and injectable contribution in that $100 million? That's number one. Number two is how much of the injectable contribution is coming from shortage products versus complex products? So that's another question. Also, switching gears to ALYMSYS, the bevacizumab biosimilar, can you just talk about the dynamics here that are driving the strong sales? Is it a limited competition in the market? Are there other things at play here? And just talk about your expectations for that product and what informs your $100 million plus in sales by 2025.
Chintu Patel: New product launches, let's just go back a little bit. Last five years, if you go by the NPLs and you total that to this year's revenue is about $765 million we have added in new product launches. And what we see going forward – and this is just within generics injectables and biosimilars. We can break it down for you later on, but stay on the bigger picture is that why we are able to grow this and why in the United States this business – this is just a US number. Internationals are separate. Why this is a big deal? Because I think it's for – over time, people have been focused on price erosion and have ignored the entire biggest market for the affordable medicines is United States and we now expect the next four years – if you annualize our revenue of next four years from – in 2028, that would be additional $800 million to $1 billion added to NPLs. And you know we've been working on such a strong pipeline and in-licensing strong products. On page 7 of our presentation, we have listed out many of them, like 60 products being launched in 2024 and 2025. 15 of them are high value. So you can see more and more high values are happening as you go year out. And we have not disclosed certain pipeline assets for competitive reasons, as well as we have not disclosed some of the in-licensing products that we have or working on it for competitive reasons. So very excited to – and these are risk adjusted number I gave you. So this $100 million is – the breakdown we can provide you later on between the…
Tasos Konidaris: I can provide. So $100 million, it's a combination of a couple things. Combination of products, if you remember last year, towards the end of Q4, quite a number of new products, close to I think 13 or so products were approved in Q4 of last year. So that's kind of the annualization of those revenues, as well as new product launches this year. So that $100 million number, it's not a certainty, but a high degree of confidence, point number one. When you break it out between retail and injectable, it's pretty much almost like 50-50, 60-40 between – so it's evenly split. Retail products like Naloxone, right, on one side, injectable products like PEMRYDI and the remaining of the other smaller injectable products. So it's evenly split between retail and injectables.
Chirag Patel: Your next question on shortages versus regular. Shortages make up very small numbers at this point. It's our regular products that we've been expanding the market, so demand is coming our way because we are the best quality and consistent supplier out in the market. So our customers are trusting us and more and more trust has been established. Your question regarding ALYMSYS, we have a very strong team. The commercial team has done a superb job. Amneal reputation, Amneal's basket of 300 products, we bring a lot more to the table for our customers than if you're a pure play biosimilar. So this is why I believe, for the future, you will see the companies being more successful who have a broader portfolio and who are working closely, whether it's oncologists, the community oncologists, or the hospitals, or the PBMs because we provide tremendous value to them. So we have a better negotiating powers with them or advantages versus the pure play biosimilars. And we are going to keep improving those. So, ALYMSYS, you will see even higher market share coming up. As well as Fylnetra, when we add OBI, you will start seeing the uptake on the market share as well.
David Amsellem: Just to clarify, the $100 million does not include naloxone. I think I saw a footnote for that in the slides, but I just want to make sure that's correct, the $100 million does not include naloxone.
Joe Renda: David, that's correct. The estimate we had on the Q4 call and reiterate, $30 million plus for naloxone, $100 million is for the rest of the NPLs this year.
Chintu Patel: David, you can see the five – my brother mentioned five already launched, which are good value products, complex.
Operator: The next question is from Balaji Prasad with Barclays.
Balaji Prasad: Congratulations on the results. Couple of questions from me. Starting with the Generic side, I was slightly surprised to see Amneal's Para IV on XIFAXAN. Bausch has been vehemently defending this from years versus a host of generic companies settled there. So how differentiated is your Para IV versus others? How realistic of an opportunity is this versus any other generic company? And similar question on the Restasis too. For years, generic companies have flagged this as an opportunity and struggle to get approval for their version, how should we think about it? Secondly, on AvKARE, I saw that versus last quarter's presentation where you had the long-term guide at $600 million, you raised it to $650 million. What drove that increase in revenue guidance and what is the EBITDA impact of it?
Chintu Patel: So on rifaximin, we always work on very unique and key products and we do have a position. It's something confidential. I don't want to get into the detail. We're excited about rifaximin opportunity. But it remains to be seen how it develops. There are multiple things that is involved. So we cannot comment at this time on any of the details. On Restasis, yeah, it is a very complex product. We are advancing our ANDA and we are expected to launch Restasis next year in 2025. We are very hopeful on that.
Chirag Patel: On your AvKARE question, Balaji, is – yeah, it is growing really well. And the lord of government product, VA, DOD has – this is the advantage for – you get some advantage being American company and having manufacturing capacity in America. So we're taking a full advantage of that and this is why you see the growth in AvKARE and it would continue to grow.
Tasos Konidaris: Balaji, can you just repeat your other question?
Balaji Prasad: The impact of AvKARE and EBITDA, what I'm also trying to figure out is, with your last 12-months revenue, EBITDA already being close to $590 million and with a stronger revenue trajectory looking that much clearer for us now, what are the upside-downside risks towards the higher end of your EBITDA guidance? And if the AvKARE long-term guidance rate is – and what's the impact of AvKARE guidance raise on the EBITDA too?
Tasos Konidaris: What happens is, AvKARE has been growing along with the rest of the business. So we're not relying on any specific segment, whether or not it's Generic, AvKARE, Specialty, biosimilars to kind of carry the day. So our growth continues to be across all our businesses. Point number one. Point number two is, the upsides and downsides of the business is, we continue to rely on new product launches, robust new product approvals and launches to kind of carry the day. So we're not always in control of that. So that depends, as you know, with the regulatory authorities. So some years may be ahead of plan, some years may be a little delayed, but all of those will come. But the cadence of it is not totally in our control. So that's something we just want to be mindful of, number one. Number two is IPX203. So as we discussed, the vast majority of the potential launch expenses of IPX203 are built into our existing guidance, right? So that way we are conservative. If we get approval, then we will have to look at, I think, an incremental top and bottom line contribution of that revenue. So, the downside is protected, the upside has not been built in. And AvKARE just continues to grow nicely. So hopefully that gives you a sense. The final thing I would say is the type of investments we choose to make, right, to kind of drive. So a lot of it is variable, it's within our control. So if we think the year plays out incredibly well, we may choose to make some additional investments. If the year is playing a little tighter than we thought, we may just kind of push back a couple potential deals.
Chintu Patel: The momentum, Balaji, has been strong, as you can see, the six key products have been approved already. So, we feel very good on it, how the momentum is great and the pipeline is delivering.
Balaji Prasad: Congratulations.
Operator: The next question is from Chris Schott (ETR:1SXP) with J.P. Morgan.
Chris Schott: Just a couple for me. Maybe first on biosimilar Prolia and XGEVA. Can you just elaborate a little bit more on the opportunity for these two. And maybe just specifically launch timelines in light of the recent Sandoz (SIX:SDZ) settlement, and of the two brands, is it either more interesting to you than the other, just given obviously different market dynamics between the two of them. Second question, naloxone, between the public market and retail channel, what are you seeing as the bigger opportunity and does the opioid settlement at all impact how you think about that? Kust finally, AvKARE, obviously great performance here, but just interested in your latest thoughts on potential to monetize that business and how you're thinking about that.
Chintu Patel: Let's start with biosimilars, Prolia and XGEVA, we are equipped to sell in both channels, the onco channel as well as PBM. We expect the launch in 2026, maybe a bit early. We will see how the filing – I think one is early, one is going to be a little bit later. And we expect. We expect the market penetration to be very good because we already have established relationship and by then we'll have more established relationship with the community oncology groups as well as the hospital groups and contracting PBMs, relationship overall. So we expect to generate a good [indiscernible] should go well above $100 million for these products. Your second question on naloxone, the retail side is slow, the government is where most of the demand is state-wise. Retail is probably 10%, 20%. We already have contracts with CBS and Walgreens to supply them and already have supplied them, both of them. And government is the State of California, biggest state we get. We are working with other major states, obviously our home states. And we should be getting more business from government and this opportunity will become really big. And our settlement does not really impact if you do the math, which Tony can follow up with you later on. There's very little of products which we have 10 million capacity, so no issue whatsoever. And AvKARE, as we have said it earlier, strategic options are open, the business is performing really well. We're not in the rush to do anything. If we get the right price, we will transact. And delever massively, we'll pay down the gross debt in a huge amount, which – it's been a great acquisition for us. And either way, we're fine with the AvKARE.
Operator: Thank you. We have no further questions, so I will hand back over to Chirag Patel to conclude the call. Thank you. Thank you. So Q1 was an outstanding start to 2024 as the momentum builds across all areas of our diversified business. Our recent naloxone launch is the latest example. And at Amneal, we love what we do. And our teams are fired up, high momentum across the company in – all over United States, Ireland, all over India. And we just could not be even more excited for overall the health and the performance of our company. So thank you everyone and have a great day.
End of Q&A:
Operator: Thank you, Chirag. This concludes today's call. Thank you for joining. You may now disconnect your lines.
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