Fennec Pharmaceuticals Inc. (NASDAQ:FENC) Q4 2023 Earnings Call Transcript

Adrian Haigh: There certainly has been that confusion that’s going to be taken out. So it very clearly says STS PEDMARK and then it says STS Hope. And there’s also a footnote there saying that the products are not interchangeable.

Chase Knickerbocker: And so you guys are confident that ASP is going to be accurate for your J-Code to reflect the pricing of your product starting April 1st?

Adrian Haigh: Yes.

Chase Knickerbocker: And if we kind of think about how that kind of parlays into maybe some of the confusion that was seen in the AYA population and those physicians. I mean, how should we think about potentially some volume kind of coming in, in that April 1st time frame that once that confusion is kind of corrected, do you have a good handle on what kind of volumes out there that wasn’t using your product?

Rosty Raykov: So what I would say, Chase, is that, as you know, this is not a chronic treatment. So you don’t sort of have patients just waiting for it, it’s really when the patient starts and then when the patient finishes with cisplatin treatment. So overall, we visited many of these community oncology centers where the setting for cisplatin treatment takes place. And as Adrian mentioned from his comments, this is where the volume of cisplatin is administered for these patients and also where PEDMARK would be administered in this AYA population. So I think we have to wait and see how this plays out. But again, based on the numbers, we’re highly encouraged that that will be well received.

Chase Knickerbocker: And then maybe one more around the business and then one on financials. Just around the FDA communication. First of all, have you seen kind of any influx in kind of volume from that or subsequent to that communication? And then second, can you just update us on some of the metrics that you gave last quarter as far as kind of being in 20% of those 200 institutions and the max kind of being 25% penetration into an institution? Sorry if I missed that but just an update there.

Rosty Raykov: So maybe, Robert, you can address that, and then maybe, Adrian, you can address the earlier part.

Robert Andrade: Chase, I mean, our penetration continues to grow. I think that’s reflected certainly in our net revenues. We don’t want to get — set ourselves up on the guardrails and in particular, also as we expand in the market with the AYA population in the community hospitals. So those bases, the 25% and the 20% have certainly grown. But we’re going to shy away from getting into the specific growth numbers at this time.

Rosty Raykov: And Adrian, maybe you could chime one or two, I know you had in your prepared remarks in terms of how the P&T committees and hospitals take this FDA safety communication and how quickly they have that changed.

Adrian Haigh: As I said, unfortunately, this wasn’t sent to individual doctors or hospitals, or pharmacists. It was sent to organizations, and I think it’s about 12 different organizations. And initially, when our sales force went out, have you heard about the recent communications from the FDA? No, I haven’t seen it. So the sales force has had to basically go out with the laptops or open up the laptops and show the e-mail. And then things don’t happen overnight. This have to go through a formulary committee process, there has to be discussion, people have to get buy-in. And so these formulary committee meetings in most cases are just been scheduled or just about to take place. There’s a handful that have stopped compounding immediately. But this takes time. So we have seen some increased use but it is not like switching a light on, it’s slow.

Chase Knickerbocker: And then just lastly, Robert, apologies for taking up so much time, guys, but I just want to dig in a little bit more on the SG&A. Can you give us a little bit more sense of what was in the quarter, at least benchmark us a little bit that we should consider kind of onetime expenses from any sort of consulting spend or deal related expenses in Europe? Should we think of SG&A being flat once we back those out from Q3? And then as we look into 2024, how should we phase out those expenses, are we flat from an OpEx perspective into Q1 and then it starts to phase out, or how should we think about that?

Robert Andrade: I think you have a good benchmark there. Certainly in Q4, we did have a good amount of expenses related to our EU preparation and launch, which we believe is well worth it. That will continue. So those SG&A levels will continue into Q1 and start tailing off certainly into Q2. And our understanding is that it will basically go to very little, if any, for the second half of the year, kind of similar to my remarks.

Operator: Our next question will be a follow-up from Dipesh Patel of H.C. Wainwright.

Dipesh Patel: This is Dipesh Patel on for Ron Selvaraju. Several questions. The first is, I’m wondering what are the stocking patterns like for PEDMARK at US hospitals and how does Fennec expect this to evolve over time?

Rosty Raykov: So I will take that. So there’s roughly 200 hospitals that are largely affiliated with COG and CCN, and those hospitals, obviously, are the ones that we target. They treat the pediatric patients largely in-patient. Those hospitals, they — as we discussed in earlier calls, they go through a very rigorous P&T process to approve a drug and formulary before start using it. We had overall, I would say, a limited success in some of those accounts. And now with the FDA communication on the safety risks, we’re encouraged by that and our sales force as well as our medical team is out there educating. And as Adrian mentioned, we’re in front of many of these hospitals and we’re hopeful that — and we’ve seen a little bit of change, but we’d like to obviously see additional in the coming months.