ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) Q1 2024 Earnings Call Transcript

And we’re seeing growth across specialties, core specialties, and the newer specialties. For generics, we continue to be oriented to high single-digit, low double-digit year-on-year growth with the continued cadence of new product launches. We launched six products in the first quarter and that cadence will continue supported by strong operational excellence. And then for established brands, our forward-looking current guidance does not assume any further benefit from supply tailwinds. So, our reiterated current guidance this morning contains no further supply tailwinds for established brands, which is consistent with the current market environment. Trust that answers that question — both those questions regarding the rest of the quarter across the four segments as well as what we saw in Q1.

Operator: Thank you. We’ll take our next question from Les Sulewski with Truist Securities. Your line is open.

Leszek Sulewski: Good morning, guys. Thank you for taking my questions and congrats on the progress in Q1. So, first on the generics front, how much of that 10% growth was driven by new product uptake versus volume from the legacy portfolio? And I guess what impact was due to a pricing tailwind, if any? And then you mentioned the supply tailwinds in Q1, impacting branded products, I guess, how does that kind of play out for the remainder of the year, if that comes off? And then lastly, what is the reasoning on the dispute of the royalty rights by CG Oncology? Can we expect some sort of a resolution this year or in the near term? And would that be in a monetary settlement or do you think you have a case for retaining these royalties? Thank you.

Nikhil Lalwani: Good morning, Les, and thank you. Your first question regarding the 10% growth of — in generics, how much of that was from new launches versus volume versus pricing? Look, again, we try to strike a balance in terms of the information that we share, wanting to be helpful. We do not typically break this out in terms of what is the — our revenues, how much came from new launches versus baseline products. What we can say is, as the other industry leaders, the generics industry leaders have been saying, there is an improvement in the pricing environment for the generics market, driven by a number of different factors, including the challenges faced on supply by other players. What we can also say is that our new product launch cadence continues, right?

And we had six new launches in the first quarter, and we expect the new launch cadence to continue over the subsequent quarters. And then finally our baseline business remains strengthened by our strong operational excellence, strong GMP track record across our manufacturing sites. Our manufacturing sites are in the US and all of these factors help us be a partner of choice for our customers, and that strengthens our generics business. Your next question was on the supply tailwinds and the future outlook for the same. So we did see supply related tailwinds for the first quarter. We reported that from the February 29 conference call that we would include it in the first quarter. Benefit from supply tailwinds were only included for quarter one for established brands.

And the guidance that we gave, and that continues to be so, and our reiterated guidance assumes that there will be no further benefit from supply tailwinds for established brands. On the third question regarding CG Oncology and the litigation, I’ll turn it over to Steve to take that question.

Stephen Carey: Yeah, thank you, Nikhil, and good morning, Les. And thanks for the question. ANI’s policy is not to comment on pending litigation. ANI has filed suit against CG Oncology seeking various forms of relief. The public record of ANI’s suit against CG Oncology provides additional background. I would also refer you to footnote number twelve to our financial statements filed in Form 10-Q this morning, which can be found on page number 27 and there you’ll find more information regarding the pending litigation and the status. Thank you.

Operator: Thank you. We’ll take our next question from Vamil Divan with Guggenheim Securities. Your line is open.

Vamil Divan: Great. Thank you for taking my questions. Hopefully, you can hear me okay, I’m traveling today, but just a couple of follow-up questions on topics that you already talked about a little bit. So one, in terms of established brands, if this sort of supply tailwind is sort of easing, or you’re saying the current market dynamics are suggesting less of a benefit, can you just talk about how we should think about that segment on an organic basis going forward or what’s the underlying growth or decline do you think is reasonable? This has been so volatile because of all that, the tailwinds here. Tough to see what the underlying performance is that we should expect going forward. The second question would be, appreciate the added color on the CG Oncology litigation.

I’m just curious if you can talk about the — you do have a stake in the company, so if you can just comment on sort of your sort of longer-term interest in maintaining that stake, and if that’s in any way impacted by the litigation. And then my third question is on the expense side. SG&A and R&D were a little bit higher than what we had forecasted this quarter. So just curious, is there any one-time dynamics there that we should keep in mind as we forecast the rest of the year? Thank you.

Nikhil Lalwani: Good morning, Les, and thank you for joining and thank you for doing so even though you’re traveling, we appreciate it. Look, our — regarding your first question, right, of how to think about the outlook for established brands, we reiterated our total company guidance of $520 million to $542 million in revenues. Of this, we continue to expect our lead rare disease asset Cortrophin Gel to deliver $170 million to $180 million. Therefore, generics, established brands, and others will do about $350 million to $362 million. For generics, we continue to expect growth in the high single-digit, low double-digit growth basis on a base of $270 million from last year. And that should frame clearly for you how we think about established brands in the rest of 2024.