ADMA Biologics, Inc. (NASDAQ:ADMA) Q4 2022 Earnings Call Transcript

These investments on yield enhancement and enhancing our RSP testing capabilities, they’re investments, but they’re not material to the point that they’re going to impact our cash on hand or our profitability outlook. For very small investments, we think that these are activities that are going to really reap tremendous benefits the overall financial outlook. And we’re not yet prepared to quantify this, but we still are saying it’s a 70-30, 60-40 revenue split between BIVIGAM and our higher-margin hyperimmunes, ASCENIV and Nabi-HB. Don’t want to forget Nabi. Nabi is hanging in there, 60%, 70% margin. We love that product; ASCENIV, in the 80s range; and BIVIGAM’s margins improving into that 30%, 40% range. We think that we’ve got the opportunity to be in that 50% to 60% gross margin, bringing 25%, 30% to the bottom line.

So we feel really good about this. And as we expand more on our fill-finish capabilities, as we expand and hopefully can unlock some additional yield through some of these exciting process development programs that we’ve been executing in the first quarter, I think that the guidance that we’ve given is only the beginning, Kristen. And I want to make everybody happy. We can’t do it all at once, but I think that our company really has bolstered itself with some really great thought leaders and really great staff here. And I think that we are positioning this company for continued success and growth.

Kristen Kluska: And now that you have a lot more experience with ASCENIV, and I know that you opined in the press release that publications are potentially in the works, looking back at the clinical trial experience, I think you had about 60 patients there. So I’m wondering, now that you have this kind of real-world experience, if the effects that you’re familiar with at least are in line with what’s on the label, if you’re seeing even better benefits if patients are on the treatment longer? Really, like anything that you can help us understand outside of just the label experience.

Adam Grossman: I am hearing my compliance team whispering in my ear, Kristen. I think there have been some publications out there. There’s certainly some data that have been published by certain KOLs in the community. I think we’ve had a couple of publications as well at the medical conferences, medical meetings. And I could hypothesize in private with you, but to just state, I just don’t have robust data for it right now. I don’t think would be appropriate. But what I can say is that I’m a big believer that clinicians prescribe products if they work. Just because a label says something, sure, they may try it, but they’re not going to keep a patient on therapy if it’s not doing what it’s intended to do or better. I think ASCENIV, especially at its price point, I mean, I think that there are high expectations for the drug.

And I think the best way to answer your question is that we are seeing durable, persistent reordering patterns. We’re seeing durable utilization. We’re seeing increased pull-through, plain and simple. And I think that, that comes from a product that is delivering results that are above and beyond what maybe were even measured in a clinical trial. Our data for ASCENIV — and again, it was not a head-to-head study against any other IG product — but our data for ASCENIV showed a very low rate of antibiotic use, a very low rate of days missed at work and school, low rate of hospitalizations. Anecdotally, and I think this is probably in the publication, patient diaries, again, these are, again, anecdotal supplemental data, people felt good on the product.

They felt better. And if you look at our asceniv.com website and if you poke around there, this is not a drug for everybody. This is for the patients that have chronic and persistent infections. These are patients who are failing or not thriving standard IG therapy. They need a change. We heard that from the ASCENIV patient speakers at our national business meeting. And I really just feel that there’s something unique about the antibody profile of the product. I think that RSV, again, is that marker for these high responder donors. And there is some data published there. But I really feel that the fact that the product is continuing to grow. I think that, that answers your question without me saying something that’s going to get me yelled at by somebody.