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

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Oren Livnat: Okay. And again, I think just to follow on an earlier question, lastly, yeah, Q1 spending looked a little high. Or I guess the implication is that with your full-year guidance that will basically be flat or even flat to down the rest of the year. Am I interpreting that correctly or are you just going to play it by ear on the guidance front and if new investments are warranted in Cortrophin, you’ll keep making them?

Nikhil Lalwani: Yeah, look, we currently expect SG&A to be fairly ratable throughout the year, and as such, Q1 expense is a fair proxy for future quarters, excluding the normal impacts of certain human capital costs, such as merit, which kicks in April, and normal course onboarding of incremental headcount. As a general comment, R&D spend can be a bit more lumpy. However, Q1 spend is a decent anchor point for which any given quarter may have moderate variability from. Our current guidance, which is a reiteration of the guidance from February 29, factors all of this in. So there is all the investments that we’re talking about and all the trends that I just spoke about in SG&A and R&D is all factored into the guidance that we have given.

Oren Livnat: Okay. And lastly, I’m sorry, I ask many questions. I know several of us have touched on the same thing. I just want to be clear, in your guidance with regards to established brands, based on the other moving parts, I’m correct in assuming you and what you see today see that line dropping somewhat precipitously back to much lower levels as early as this quarter, correct? Or should we assume your guidance is just always conservative and you’ll take it on a quarter-by-quarter basis and it could crush again in 2Q, and then we’ll assume it declines from there and so on and so forth?

Nikhil Lalwani: Our 2024 guidance assumed established brand supply tailwinds for the first quarter and no supply tailwinds in subsequent quarters, and the current market environment is consistent with those assumptions.

Oren Livnat: Okay, I hear you. Thank you so much. Congrats on another impressive quarter.

Nikhil Lalwani: Yes, thank you.

Stephen Carey: Thank you, Oren.

Operator: Thank you. We’ll take our last question from Tim Chiang with Capital One. Your line is open.

Timothy Chiang: Great, thanks. Nikhil, could you just comment on how this 1-mL vial size product is doing? I know you just launched it in the fourth quarter. Any sort of feedback you’re getting from rheumatologists?

Nikhil Lalwani: Yeah. Good morning, Tim, and thank you for your question. We’re still in the early days for the 1-mL vial for acute gouty arthritis flares. We launched the 1-mL vials specifically for its dosing size and the fact that it’s appropriate for acute gouty arthritis flares, which is an indication the competitor does not have. In addition, our unique J-code enables administration by physicians. The 5-mL vial is largely administered on a — largely used on a self-administered basis. So again, early days and we look forward to updating you on the progress of the 1-mL vial for acute gaudy arthritis flares.

Timothy Chiang: Okay, great. And maybe just one follow-up. What could you sort of provide in terms of color and think to what sort of progress you’re making on the M&A front? Have you guys looked at a lot of products over the past months? Could you comment on just what the environment looks like for you guys right now?

Nikhil Lalwani: Yeah, look, the — we’re continuing to evaluate multiple targets. We have evaluated targets — multiple targets since we started. We have done diligence on targets and passed the BD environment competitiveness is in line with our expectations. And look we remain confident in our ability to expand the scope and scale of our rare disease business through M&A. And I think maybe the last thing is, look, we remain steadfast in ensuring that we’re diligent and highly selective as we seek to deploy capital for ANI to find the right asset or assets.

Timothy Chiang: Okay, great. That’s very helpful. Thanks, Nikhil.

Nikhil Lalwani: Thank you, Tim.

Operator: Thank you. That concludes today’s teleconference. Thank you for your participation. You may now disconnect and have a wonderful day.

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