Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q2 2023 Earnings Call Transcript

Chirag Patel: Les, thank you very much. Type A meetings will be scheduled as soon as possible in the very near future. So, the interesting question on a trend on low-margin products. So, the low-margin products have reached very, very bottom. And it cannot go any further. It has to go up, even doesn’t matter where it is supplied from. The cost even in manufacturing in India is going up, so is in Europe, so is in Israel. So, we don’t expect – the companies cannot survive, right. Charlie Munger would say that no businesses can be successful when they lose money. So, that has to change the low margin trends. On the deals and the consolidation, as you know, the industry had faced tremendous unfair treatment from FTC compared with what they allow the buying groups and vertical integrations with PBM insurance company retails, and they do not allow the generics manufacturers to consolidate.

That has to change. It’s so obvious we need the strong generics industry in order to alleviate shortages, in order to have invest in further automation, continuous manufacturing, next-generation technologies. It fills 92% of prescriptions. So, we hope FTC allows consolidation going forward, and we would love to play a major role in consolidating the generics industry if we are allowed to do so, but at the right time. Right now, we are completely focused on deleveraging. We would want to substantially reduce our debt, which we can do it from our operating cash flow. And it does not compromise any of our investments. We still have somewhere between $160 million to – in the future, it could be $180 million, $200 million every year, R&D investments, which is very efficient R&D engines we have.

We have right capacity already built. So, we would – we spend $50 million, $60 million in CapEx. And then, we also do tuck-in deals. So, we don’t stop doing tuck-in deals, and we have reallocated our R&D with the simple generics getting very low dollars and then more complex, more biosimilars, more specialty is getting the allocation now. So, that’s – the larger deals would have to wait, and we see how the environment will work out, but we absolutely remain very optimistic that at some point, the generics consolidation, especially in the U.S., could happen.

Les Sulewski: Great. Thank you for that color. And just on the manufacturing footprint and capacity that you have added on, any concerns around FDA inspections? Maybe just walk us through what the latest status is specifically in regards to your overseas facilities. Thank you.

Chintu Patel: Yes. Hi. So, Amneal has a standard quality track record. We have been inspected globally. More than half of our 95 inspections been in India. And so far, we have no FDA concerns. Most of our inspections are without 483s or minor 483s. This year alone, we had three of our sites inspected in India, and we had no 483 observations. Over the many, many years, we have built a solid quality culture, and we continue to grow and cultivate that culture of quality. So, whether the plants are in India and U.S., our systems are so robust and so strong that we don’t anticipate issues coming out of those plants during the FDA inspections.

Operator: [Operator Instructions] Our next question comes from David Amsellem from Piper Sandler. David, your line is now open. Please proceed.

David Amsellem: Thanks and sorry for the tech issues earlier, and thanks for fitting me in. So, just a couple. So, with the lean into injectables and the shortage situation and given your commentary, does that in any way change how you are thinking about tuck-ins and specifically, the extent to which you are going to continue to add to the brand business through biz dev and M&A? How should we think about that as it’s becoming clear that the generics business is performing better and you see, in particular, starting to reap the fruits of your investment in injectables? So, that’s number one. Then number two, you talked about continued momentum into 2024. Just wondering if you can provide some more color on that in terms of how many launches? How much of those will be injectables? How much of those will be injectables that benefit from shortages? And how we should just think about any specific products that might have outsized importance for next year? Thanks.

Chirag Patel: Thank you, David. So, injectables is all organic homegrown story, does not require any tuck-in acquisitions. And again, my comments on generic industry is broader comment, not that Amneal is looking to do anything at this point. And as far as the investment in brand business, which is our number one priority because that is where we have invested since 2018, acquiring Impax, Rytary, Unithroid, KSP we acquired. So, we continue to focus there, and probably one of the few companies that can do both really good. And if you look at the overall, let’s say, in 4 years, we are going to spend $700 million, $800 million or $900 million in R&D, half of that money will go into, or more than half, would be on a branded side, which we constantly look for the either partnership deals and may go – some of them may go on a biosimilar side.

So, totally focused on specialty, biosimilars and then injectables, and generics is more organic story for us. Second question, go ahead, Chintu.