BioLineRx Ltd. (NASDAQ:BLRX) Q4 2022 Earnings Call Transcript

Joe Pantginis: And good luck on the upcoming PDUFA. So looking towards some of Holly’s comments, I was just curious, obviously, you’re not rightsized yet with regard to commercial personnel because you said you’re bringing on a focused sales force or in the process of doing that. How should we consider the phasing of that? Or is it going to be gated on the approval? Or will any of these people be in place first?

Philip Serlin: Go ahead, Holly.

Holly May: Yes, sure. So thanks for the question, Joe. So we understand that you need to invest some money to make money. So we are — we believe we are investing the right amount of money in kind of those prelaunch activities that we need to go to market. That said, we are also very conscious that we are a small company and that we need to be prudent in how we think about our people and our investments. So we are staging the field people who are calling on stakeholders appropriately. And we know that the medical affairs folks who are in the field, they are there. And we are the next — personnel that we’re putting that we’re staging into the field will be those who can speak more economically to like the payer and state and economic — account management-type people.

And then we are going to be hiring our sales professional because we want them in-field ready to go. And just enough time so that there’s a little bit of being able to get to know the accounts and get to know some customers but they’re not going to be in field for months and months prior to our PDUFA date. The way that we have things staged right now though, we do believe that they will be in the field in enough time if we happen to get an early PDUFA. So I — I mean, an early approval. So, I haven’t given you the specific dates but we have a very well thought-out plan of making sure that we get people on board, get them trained and get them ready for a potential earlier date if that should come and then certainly with the full complement of launch assets and materials by September.

Joe Pantginis: Got it. No, that’s helpful. And then I guess this sort of also goes to the broader profile for Motixafortide. But if you look at stem cell mobilization right now, how should we be viewing at this moment in March 2023, your ex U.S. use for commercialization? Obviously, U.S. is focused. But with regard to the single — the individual geographies, the individual reimbursement patterns for each country and what it has to do. And from a broader concept, how does that factor into any potential ongoing discussions right now for indications in oncology beyond stem cell mobilization?

Philip Serlin: Well, that’s a broad question. Okay. So let me discuss first of all, about other territories. So I think we’ve said this a number of times and I’ll just repeat it again. We want to look at other territories but we are not going to do anything until we first get this product approved in the U.S. and launch it in the U.S. Following the approval and the successful launch, we will then look at other territories, not on our own, though, we will — we are already speaking with potential partners but what we may get into, obviously, more detailed discussions later on regarding other territories but we will not commercialize on our own in other territories. But there are certain territories, for example, that approval process is easier. They rely somewhat on the U.S. approval. We are, of course, looking at Europe and — but again, I think that right now, we realize with the resources we have and the talent we have right now, our focus is clearly on the U.S.

Joe Pantginis: I was just going to say broad question for potential broad opportunity. Go ahead, Phil.