Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q4 2023 Earnings Call Transcript

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. 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.