ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) Q3 2023 Earnings Call Transcript

Nikhil Lalwani : Yes. I think the generics’ Q3 performance is driven by a combination of new product launches, opportunities from the supply chain disruptions and continued strong performance with our base business. So it’s there’s — you asked the question around seasonality. We don’t believe that from the product portfolio we have, there’s a seasonality impact on that. And then as far as 2024 those look, we’re working through many moving parts, and we’ll plan on releasing our 2024 financial guidance on our year-end earnings call, which will occur towards the end of February. But we continue to, as you would have seen, even in the R&D expense, we continue to invest in R&D for the generics business to support the future growth. And that growth will come from new product launches cost competitiveness and supply chain reliability.

Operator: We’ll take our next question from Vamil Divan with Guggenheim Securities.

Vamil Divan : So a couple of questions for me. First on the Cortrophin side. I know you mentioned, talked about the 1 mL. And I’m curious about the gouty arthritis opportunity in particular, and that is sort of a unique one for you. Can you maybe just quantify, I guess, initially any sort of feedback or kind of doctor interest in that indication, but also does quantify what you see as a potential opportunity in that specific indication? And then my second question is going back to some of the comments around the sort of softness that you’re seeing, I mean the main thing is really rather frankly 2024, and I know you’re not going to give guidance until in February. But if I look at things right now, based on where you’re planning to leave 2023, it looks like the sort of consensus number you are assuming very minimal sales growth for next year.

And EPS is actually sort of below where you leave this year. So I’m just wondering if you can provide any color at all on how we should think about sort of trajectory for the different businesses for next year at this point, understanding that you will give more detail a few months from now, but it does seem like there’s a pretty big disconnect from the trajectory of the business and where consensus numbers are right now for next year?

Nikhil Lalwani : All right. I think, first, your question around gout, like many of our other indications, right, multiple sclerosis, rheumatoid arthritis, et cetera, we’re focused on patients for whom current treatments are not sufficient. In the case of gout flares, there are patients — acute gouty arthritis flares, there are patients who might benefit from an additional option from the other therapeutics that are available. We have received positive initial physician response at this so far. It’s not something that we can we’re able to quantify at this point, or and again, as we’ve done consistently, we try to find a balance between sharing information to assist the investment community why not giving away competitively sensitive data.

So please stay tuned and we will come back on — to share more about the gout launch. You should know that we have assumed no material revenues from out in the 2023 guidance. So I think that could be a point or just to — because it’s early days in the launch. And then going back to your question — your second question around the 2024 and how that links to the 2023 guidance. I mean, Bob and you’ve been working with us long enough to know that we — as we’ve done consistently, we deliver what we commit to, and this is the continuation of that philosophy of being more conservative while giving guidance. And in terms of 2024, we do see continued evolution of the PCG launch, right, ongoing strong execution in our tax business. You’ve also talked about the efforts that we’re making to leverage the PCG launch as our anchor asset in rare disease and build on that through — and the multiple moving parts, right?