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

Even the supply chain disruptions, right, as I’ve spoken about, there are opportunities that we’ve had. Some of them have gone away. There are new ones that are in the bucket or current months that are persisting. So there are many moving parts that we’re working through, Cortrophin evolution, strong Cortrophin evolution, the rare disease M&A, the generics growth and the status of the supply chain disruptions. And we plan on releasing our 2024 financial guidance as we move forward.

Vamil Divan : Okay. Maybe just 1 quick follow-up, just again on the sort of commentary around the softening in specific markets you’re seeing, would you say is that more on the Generic side or more Established Brands? Is there any way to just sort of give us a little bit of directional sense on where you might be seeing more of the impact?

Nikhil Lalwani : Sure. So we are seeing impact across products, both in Generics and in Established Brands. In Generics, some of the — as Steve mentioned in his remarks, the growth that we’re seeing from the other products and the new launches is tempering some of that decline. So in the Q4 numbers, you will see the impact more on the established brand side than you will on the generics side.

Operator: We’ll take our next question from Oren Livnat with H.C. Wainright.

Oren Livnat : If I could just, I guess, approach the same discussion from a little bit different perspective. Obviously, you’ve raised guidance dramatically from the beginning of the year from initial guidance, I think, about $100 million and 9% EPS raise, mostly from the generics. When you issue guidance, I guess, how conservative are you being? How are you looking at the world with regards to all these disruptions and opportunities you have? Do you have to — do you have much visibility on these looking forward? Or do you assume the ones that you already have in hand will end shortly looking forward to be extremely conservative in your guidance, I guess? What I’m asking is it’s not surprising that some of the opportunities you’ve experienced this year are rolling off, right?

They don’t last forever. But when you give first-time guidance next year or when you have given guidance each quarter of this year, what are you assuming for the durability of those opportunities? And do you build in really anything for expected new disruptions to benefit — benefit disrupting to come your way? I have a follow-up.

Nikhil Lalwani : Sure, and thank you for your question. Look at — I think we’ve spoken about this, which is that when we speak to guidance or when we’ve given guidance, we obviously bake in the performance of the previous quarter and then assume that with the many moving parts, our best understanding of what subset of those opportunities will continue in the subsequent quarter — quarters, right? And we have some understanding, right? If there’s a site related issue, it takes time to resolve those. If there’s a product level specific technical issue with 1 player in a 5-player market, then we know that, that could be shorter. So we bake in that understanding as we’re giving guidance. And I think to use worse that Steve has used before, and he’s describing these — there’s always more in the previous periods when we were doing we’re not assuming that these will persist forever, and that’s why we baked that in as we give guidance.

And of course, as we learn more, we try to share that and continue our philosophy of saying what we’ll deliver and deliver what we’re saying.

Oren Livnat : Okay. And I think I appreciate you — look, I misheard you, you said the biggest quarter-over-quarter change in Q4 should be on the branded side. we’re not used to seeing the legacy brands rising similar disruptions, I guess, on the brand side, like we do in generics of products coming and going. Can you comment on whether the tailwinds you’ve had this year have been mostly a volume or a price benefit? And to the extent that, that’s moderating going forward, is that due to pricing dynamics, if it’s priced? Is that due to dynamic softening in general whether that’s because of payers and contracting, et cetera? Or is it purely a supply and demand issue as products lead the market come back, price adjust accordingly?