Fennec Pharmaceuticals Inc. (NASDAQ:FENC) Q3 2023 Earnings Call Transcript

Adrian Haigh: Yeah. And different countries have different approaches. For example, some will take into account the fact that a deaf patient is unlikely to be able to contribute because there — they drop out of school, they don’t get well-paid jobs, they become a burden on the social security system. Some countries will take that into account in their assessment. Others will say, well, how much are they just costing the healthcare system; for example, and not taking into account social security costs and loss of earnings, et cetera. So, each one of these countries has a slightly different way of looking at it. So, it’s very difficult to generalize. Where I would generalize is that we feel that in most of the countries, we’ve got sufficiently strong arguments to justify a good price.

Charles Duncan: That’s helpful. Looking forward to seeing the progress next year ex U.S. as well as U.S. Congrats on the progress in the quarter. Thank you.

Operator: One moment for our next question. Our next question comes from Dipesh Patel with H.C. Wainwright. Your line is open.

Dipesh Patel: Thank you, guys. This is Dipesh on for Ram Selvaraju. What kind of information do you expect to disclose going forward regarding the commercial trajectory of PEDMARK in the U.S.? So, for instance, a number of patients on therapy, number of new and repeat prescriptions written, total number of prescribers, or number of prescribers you have written, for example, greater than one prescription, et cetera?

Rosty Raykov: Yes, you can — that’s a good question. As you could see, we started giving a little more granularity as the business started building up, in particularly, with the accounts where we have won P&T, right, and as well as the repeat orders from those places and the penetration within the physicians within those places. So, I think as we — as the business builds up, I think we will be more granular on that, absolutely. Keep in mind, what we don’t know, of course, is that given our label that it covers many, many tumor types, we’re — best case, we’re guessing what the tumor types that are being treated.

Dipesh Patel: Okay. Thank you for that. And I have several more questions. How would you describe the current status of reimbursement and formulary access for PEDMARK?

Rosty Raykov: So in terms of reimbursement, we have not seen any major issues. So that certainly has been encouraging. In terms of the formulary process, as you could imagine, hospitals in the U.S. are under tremendous financial pressure. Their margins, net operating margins, are very thin. On the other hand, very positive is happening to them, which is they are creating a tremendous margin at their pharmacy level, and particularly, savings from biosimilars. So, as we are moving forward to get through a P&T committee, sometimes it takes us more than once, those type of considerations come into play. But obviously, it’s not easy. It’s not easy to get through a P&T committee given all the considerations, given that this comes from their DRG.

Dipesh Patel: All right, that’s very helpful. And then, how are partnership discussions progressing in Europe? And when do you expect to launch the product there?

Rosty Raykov: So I just — from the previous question, yes, we expect to launch sometimes in the second quarter next year, probably May, June next year. It’s our best guess at the moment. We are still going through a Type 2 variation where we’re switching the manufacturer from the U.S. basically into Europe, our current manufacture of PEDMARK. So, it’s also manufacturing PEDMARQSI, and they will have to be approved in the Type 2 variation. So, I think as soon as we have that, and then we obviously ship and label product into the European market, then I think we’ll be able to give you a little more granularity of what month the launch would be. But Adrian is certainly working on that given all the preparation work he’s doing on the health economics.

Dipesh Patel: Got it. And then just a couple of more questions. Do you have any plans to advance other drug candidates from your discovery stage pipeline into the clinic at this time?