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

Please note that we have assumed no supply tailwinds in Q2 through Q4 in this guidance. And this is consistent with what we forecasted in February in our original February 29 guidance and consistent with current marketplace conditions. Regarding the second question on CG Oncology, again, I’ll turn it over to Steve.

Stephen Carey: Yeah, Vamil, good morning, and thanks for taking our call this morning. Yeah, in terms of our equity position in CG Oncology, this is a position that harkens back to the November 15, 2010, transaction where the company sold assets to CG Oncology. And at that time, right, way back in that time, our equity stake was 19.9%. Obviously, during the intervening years, that ownership position has been diluted down and upon CG Oncology’s IPO in January of 2024, we hold just shy of 220,000 shares of their common stock, which, as you see, as of March 31th, was worth about $9.7 million. And that’s reflected on our balance sheet. In terms of our future plans for that holding. We’re not going to comment on that this morning.

Thank you. And then I think your last question related to SG&A, in the first quarter, in terms of SG&A, I would say you asked if there was any one-time items of any note in the first quarter actuals. And on that question, Vamil, there was none. You know, there’s always kind of intra-quarter puts and takes in certain variable spending, but nothing that I would hold out as significant or material this morning, and as we said on the prepared comments, right, the SG&A increase year-over-year does reflects principally our investments behind people costs and within that category, primarily in terms of the expansion of our field source capabilities and sales and marketing support capabilities behind Cortrophin. And in that regard, right, we’re really, as Nikhil had stated, right, we see a long multi-year trajectory for that product, which is obviously a core product for us.

And in that regard, right, we’re investing behind it for the health and trajectory in the mid to long-term.

Nikhil Lalwani: Vamil, just one other thing to add, going back to the question two, regarding CG Oncology, I’ll just go back to what Steve said, that when CG Oncology — what Steve said in his prepared remarks, when CG Oncology purchased ANI’s targeted oncolytic technology in 2010, CG Oncology undertook to pay ANI, among other things, running royalties in the amount of 5% of net sales of CG0070, also known as Cretostimogene. So, I just wanted to add that in addition to the point made on the equity position.

Vamil Divan: Okay. All right. Thank you very much.

Nikhil Lalwani: Thanks, Vamil.

Operator: Thank you. We’ll take our next question from Oren Livnat with H.C. Wainwright. Your line is open.

Oren Livnat: Thanks. I have a couple, on Cortrophin, can you talk about the evolution of the value per patient as you continue to expand the launch into broader specialties and indications, including the 1-mL launch? I’m trying to remember which patient indications use the drug for longer and/or at higher doses. And is your expansion into pulmonology and ophthalmology and gout, is that putting upward pressure on the sort of average annualized price or value per patient or not? And I have a couple follow-ups.

Nikhil Lalwani: All right. Good morning and thank you, Oren, for joining our call. I think that again, trying to strike a balance between sharing competitively sensitive information but being helpful to investors. I think your characterization at the end is appropriate, which is that there’s probably upward pressure on the value per patient with our — with going into the newer specialty areas. And we look forward to updating you on the progress on this as we move forward.

Oren Livnat: Okay. And in 1Q, I know it’s an important quarter, as you already called out for insurance resets and normal seasonal impacts, but has your overall coverage for Cortrophin changed in the New Year reflected in Q1 or maybe kicking in later in the year on an absolute basis, or your relative positioning versus Acthar?

Nikhil Lalwani: Yeah, there again trying to strike a balance, I think that we are clear that our — we’re unambiguously clear that our efforts have helped improve access for the ACTH category and have played a significant role in making the ACTH therapy available to appropriate patients in need and resulted in overall ACTH market growth. And I’ll, sort of, repeat when you add our guidance of 170 to 180 to their guidance, we expect that the overall ACTH market will grow in revenues almost 10% and go back to a number from 2021. And we believe that there is a long runway of growth for the ACTH market, but the number of patients on therapy today is significantly lower than patients a few years ago.

Oren Livnat: Okay. And on generics, I guess implied in your guidance is still pretty steady growth through the year. I think previously you indicated you expected some back-half more significant launches in there. Is that still the case? Or have you seen maybe earlier and better pull-through of launches? And so that cadence might have changed. And specifically, looking at IQVIA, and I know that has limited utility in this space, I do see one product, Hyoscyamine, that seems to have jumped out in March or appeared in March and looks like an important contributor. I don’t think you’ve ever press released that. I don’t even know what it is, to be honest. Is that something new and exciting and a material contributor, or am I reading too much into IQVIA data?

Nikhil Lalwani: Yeah, thank you for your question, Oren. I think the cadence of launches is in line with our expectation and puts us on track to deliver the high single-digit, low double-digit growth for generics in 2024. And you can expect this cadence to result in sequential growth quarter on — as you had pointed out, to deliver the high-single-digit, low-double-digit target for the full year. One of the strengths of our generics business is the diversification, right. We have over 100 product families that we sell and we do not have concentration either in our — across the product families we sell or in our new launches. And so that’s what we consider that as one of the strengths of our generics business and therefore don’t have anything specific to add on any specific launch, including the Hyoscyamine example that you gave.