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

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 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.