Balchem Corporation (NASDAQ:BCPC) Q3 2023 Earnings Call Transcript

Anthony Polak: And is there anything new on the autism drug scenario?

Ted Harris: Tony, there really is no new headline to talk about, and we certainly will address that proactively in future earnings calls as there are changes or things to update. But that doesn’t mean to say that there hasn’t been a whole lot of progress and work done behind the scenes. We have, as we have talked about in the past, moved our manufacturing to a new contract manufacturer. That’s taken us well over a year to do, but that is now complete. We have completed all of the kind of engineering batches and stability batches that needed to be completed in order to file the BLA with FDA. And so from Balchem’s perspective, we’ve been working very hard behind the scenes to get all of that done to both support the submission of the BLA as well as to ultimately support any market launch that there could be over the course of the next year or so.

We do believe and what we’re hearing from the team at CureMark is they are feverishly working on finalizing the BLA for submittal to FDA. And while there’s only a couple of months left in the year, are – expectation was that, that would be filed this year. And then it would be in the hands of FDA. Obviously, this is completely out of our control and that could leak into next year. But we do know that they’re working very hard. And we’re on every other week calls with them to make sure there’s nothing more that we can provide, and there isn’t at this point in time and just, to see how things are going, and we know that they’re working very hard on that. So that’s encouraging. But nothing headline worthy that we would have talked about such as submittal of the BLA.

When that happens, we’ll certainly let everybody know. And of course, the biggest milestone being ultimate approval of the BLA. So that’s where we are on that, Tony.

Anthony Polak: Thank you. Okay.

Ted Harris: Thanks.

Operator: Thank you. Our next question comes from Kyle May with Sidoti. Please proceed with your question.

Kyle May: Hi. Good morning, everyone.

Ted Harris: Good morning, Kyle. And welcome to the team.

Kyle May: Hi appreciate that. Looking forward to getting another story even better than I already do. But one thing – I really wanted to come back to, you had a really strong quarter from the Human Nutrition & Health segment. Ted, you talked about several strategic initiatives. And I was wondering if you could clarify if these initiatives already are starting to contribute to the growth that we saw in the third quarter or if this is something that is just going to further strengthen the business?

Ted Harris: I think that it is more something that will strengthen the business going forward. But there’s no question we’re seeing some of it now. I think that we can’t give much credit to those initiatives for the strong human nutrition health quarter that we had. But there is some in there. And we are really seeing the value of our portfolio paying off. And what I mean by that is when our sales reps are visiting our key customers and maybe our legacy customers who are buying choline or maybe our chelated minerals that we added to the portfolio in 2016. They’re also having opportunities to talk about MSM and K2 and K2 Delta. And opportunities are coming from that, and sales are coming from those opportunities. So part of the expectation of adding some of these products to our portfolio was synergy sales, and we are seeing some of those materialize.