Amneal Pharmaceuticals, Inc. Q3 FY2025 earnings call

• Strong third quarter performance with revenues of $785 million and adjusted EBITDA of $160 million, representing consecutive quarters of growth.
• Focus on diversified portfolio from generics to specialty, injectables, biosimilars, GLP-1, and complex medicines.
• CREXONT for Parkinson's disease continues to outperform, with 80% of prescriptions from IR patients and confidence in peak U.S. sales of $300M-$500M.
• BREKIYA autoinjector for migraine and cluster headache launched, allowing self-administration.
• Collaboration with Metsera in GLP-1s progressing well, with clinical programs advancing.
• Biosimilars on track to have 6 marketed by 2027, with BLA submitted for Xolair biosimilar.
• Affordable Medicines segment continues to launch new products like risperidone injectable, sodium oxybate, etc., with 17 launches in 2025 and 13 more pending.
• Operational excellence through digitalization, automation, and focus on complex dosage forms; large U.S. manufacturing footprint is a key differentiator.

In the third quarter, total company revenues were $785 million. The Affordable Medicines segment had revenue of $461 million, up 8% year over year, contributing approximately 58.7% to total revenue. Specialty segment revenue was $125 million, up 8% year over year, contributing about 15.9% to total revenue. AvKARE revenues were $199 million, up 24% year over year, contributing around 25.4% to total revenue.

• Revenues expected in the range of $3 billion to $3.1 billion.
• Adjusted EBITDA range raised to $675 million to $685 million.
• Adjusted EPS range raised to $0.75 to $0.80.
• Expected strong operating cash flow between $300 million to $330 million in 2025.
• Anticipate top and bottom line growth in 2026 and beyond supported by diversified portfolio and growth drivers like CREXONT, BREKIYA, biosimilars, and Affordable Medicines launches.

Q: Congrats on the quarter. Maybe on the Metsera partnership, could you give us your latest thinking on how the acquisition by Pfizer may impact the agreement? I know you said prior you don't expect this to change anything, given there's a Change in Control clause and that you all collaborated with Pfizer in the past. So just curious on your latest thinking there. And then we obviously saw this morning there's another bid for Metsera by Novo at a higher price. So maybe your thoughts on that dynamic as well. And if there's any meaningful difference from an annual perspective in terms of who ultimately acquires the company. And then maybe secondly, FDA came out with new draft guidance yesterday that essentially removes the need for comparative Phase III efficacy studies for biosimilars. Just curious on your thoughts in terms of how this impacts Amneal and the broader industry and market dynamics going forward.

A: Matt, I guess we chose the right partner. Metsera is doing well, I guess. And obviously there are 2 bidders now. And for us, it's really great. We've been working with Metsera for last couple of years and have devoted lots of resources from science, engineering, operations, manufacturing. Very close partner, great relationship, great company, and their programs are advancing well. As you know, Matt, I cannot comment on the current events between Pfizer and Novo, and either one of them, Amneal stands to win because of the higher name recognition on both brands with our partnership where Amneal has rights to 18 countries to market the products and agreement for supply, which is very meaningful as well. So stay tuned. And as it progresses, we'll keep you updated. Your second question, it's awesome. We've been experiencing that. We know from our partners what FDA is willing to do now since they have lots of data over last almost more than 12, 13 years, they have seen the biosimilars, the safety data, their biosimilarity data from the clinics as well. So finally, they are in agreement to push for more biosimilar approval, cut down the cost and time by half. And this is where Amneal's vertical integration would play a key role because it still will take 3 to 5 years for competitors to catch up. So it's great for the industry. Most importantly, it's great for the patients. It's going to create great access. And FDA and HHS is behind us, and entire CMS, to call out all the games that are being played by the brand companies and really promote and create a market for biosimilars. And then making those biosimilars in the United States will even further give the advantages for the companies that invest in America. So we're very excited. There are 117 molecules, only 30 are being worked on, 90 are not being worked on. And biologics, as you know, represents half of the value for the entire pharmaceutical spend. And most of those drugs are very expensive. Bringing affordable access, this is our mission, allows Amneal to take the leadership position. And what we've been saying is become America's #1 affordable medicines company, allows us, in the future if we get the vertical integration done as soon as possible, to have bigger, broader portfolio of 20 to 30 biosimilars and keep adding 5 to 7 every year. I hope that answers your question on where the biosimilars are headed. Very exciting.

Q: Just a follow up for each question, actually. On the biosimilars front, how does that change your overall strategy given this draft guidance potentially finalized as it stands. And then on the opposing side to that, do you see potentially for the increased competition where the price erosion curves ultimately resemble the traditional generics? And on Metsera, understand there are clauses in place with the current contract that you have. You're building out the facilities in India. How is your thinking about that sway the new change of control of the company and then potentially your commercialization rights in the emerging markets? Are there any safeguards in place for you to retain those? And I do have a couple of follow-ups.

A: Thank you, Les. So let's expand more on overall strategy for biosimilars. So it would expedite the development timing, it would cut down the cost by almost half. And both are very encouraging. But you still need big biologics manufacturing site, you need the [ liters ] of capacity, you need the teams of hundreds of analytical people, manufacturing, engineering to get all these done and with the U.S. standards, so with FDA and then obviously EMA follows European standards are similar. So the companies, for example, Indian companies who are focused on emerging markets in biologics for years -- for 20 years -- they would have to build a brand new infrastructure that is for the United States and develop the products from the beginning for the United States. So if Amneal increases its footprint through the vertical integration, it will give us the advantage over next 5 years. Then your question on the pricing and competitors, yes, competitors will enter. But it's still expensive. We're not talking about $2 million development of complex generics or $5 million, right? We're talking still about $40 million, $50 million, $60 million, based on the molecule. And still it takes a lot of CapEx to have the infrastructure to produce those and science capabilities and engineering. So as you know, it's complicated manufacturing. The pricing of biosimilars are way higher than the small molecule. So even when you hear the tagline of 80% reduction, if your investment is $40 million to $60 million, you're still doing great. As long as you can execute, be there, and select the molecules which are 2 competitors, 3 competitors enter first so you have advantage of insurance coverage, working with private labels, doing buy and build model, all these 3, you have to have marketing setup as well, which Amneal does have. So that is how I see the biosimilar industry blossoming over next 1, 2, 3, 4, 5, I see it up to 10 years. Even with the competition, it's a great marketplace. As dollars are large, complications are very much there, and there are many molecules to go after. Now you can select $500 million molecule, you can select $1 billion molecule, then no need to just keep going after to the $10 billion and $20 billion that would face 10 competitors. So it is a competitive industry. It was supposed to be competitive. And it will create huge value for the patient and providers and complete backing of U.S. government, which is fantastic to push this, rightfully so. And that was the main intent when the law was passed. So we remain very, very big player and will be to win biosimilars for the United States market particularly, and it also allows us to go global as well. Metsera, your second question, it's the same answer, Les, that we cannot discuss much at this point. As you know we have a solid partnership with Metsera, and we look forward to work with whoever the new partner is, and we're very excited, actually. So stay tuned and we'll update you at the right time. Chintu Patel added: And Les, just on a biosimilars I'd like to add a point to what Chirag was saying, first of all, this draft guidance is very encouraging for the entire industry. But unlike small molecules, still in large molecules there are multiple barriers of entry. So the speed to market still it's lot longer. Plus the capacity, unlike small molecule where there was a floodgate of people filing 20, 30, 40 ANDAs, it's not possible. There are 112, 115 biologics products where only 20 or 30 are being worked on. So still there are manufacturing, science, analytical is a very strong aspect of development, and the R&D does not allow you to take 5, 10 biosimilars a year. So still next 10 years if you have a head start and have a vertical integration, there's so many opportunities you can do. And with these new draft guidance, still 3 to 4 filing is max for most of the companies.