scPharmaceuticals Inc. (NASDAQ:SCPH) Q4 2023 Earnings Call Transcript

If we don’t get a quick answer from the payer, we’ll still ship them one dose overnight for free so that they have something the very next day and then it buys us another 24 hours to get through to the payer, get the answers and then ship it out for the following day. So that’s been working very well to the satisfaction of our prescribers, but to do an average, when you add in all these ones that purposely can be there for weeks or even months, we’re filling prescriptions this quarter where people wrote them in October or November, and they’re finally calling it down. We’re very happy to have them. We do not discourage the doctors from ordering in advance and getting it preapproved. They like to do that. We like to see them doing that, but it does impact both our fill rate as well as our speed to dispensing.

Chase Knickerbocker: Yes, it makes sense. I certainly appreciate the complexities there with that answer. Maybe some color just based on some of the color you’ve given around gross to net and where you expect it to end the year, that indicates that you expect to contract with some of these large Medicare Advantage payers at some point, call it, earlier midyear this year in 2024. Just kind of speak to some of that activity and the conversations that are happening in the background that kind of give you the confidence to kind of assume that those contracts are going to get done.

John Tucker: Yes. So we’ve had ongoing negotiations with — there’s 4 big payers here in Medicare. And we’ve talked about it that when we first went out, they didn’t agree with what we offered them. We didn’t agree with what they offered to us. We’ve done a couple of iterations of that. These aren’t quick iterations. You don’t pick up the phone call, pick up the phone and call on Tuesday and then give you an answer on Wednesday. It takes some time, but we’re making progress. We think it’s key. If you look at especially next year that we’re on formulary here because of how the Part D is going to reset. But we have to get these done for this year, too. So we’re pretty confident that it’s going to happen this year, and that’s why we keep messaging that the GTN is going to go.

The discount is going to go up because we’re going to be paying these rebates. And again, we’re not paying them unless we think it makes sense for the brand. But we do think being able to lower co-pays for that 30% of the patients, to get them to $100 or less and also to speed adjudication time is important to the brand to go where it’s going. So they’re progressing. We’ve said it, once we sign them, we’ll announce them. And we still plan on doing that. And yes, that’s the plan.

Operator: Our next question comes from the line of Naz Rahman with Maxim Group.

Naz Rahman: Congrats on the progress. So just a couple of questions from me on your CKD indication. So the first one is, what kind of review cycle do you expect? Do you expect a 6-month review or 1-year review for the product, or from an indication label? And two, how do you think the reimbursement conversations in reverse and paradigm — sorry, evolved for this indication? Like, are you already having discussions with payers regarding this potential label expansion so you might see that benefit upon approval? Or do you have to kind of go back and have additional discussions and we might see the benefit of those discussions and reimbursement sometime later in ’25? Like, how do you think about PDUFA date?

John Tucker: Yes, I’ll take the first one. Steve, you can take the next one. We anticipate a 10-month review, it’s not a newer entity, which would be a 12 months. But we anticipate, and again, we’ve said we’re filing next month and we will file in April, will receive our PDUFA date, but we anticipate that will be 10 months. Is there a chance it could be 6 months? There’s always a chance, but I think, to be conservative, we’d say, 10 months, but there wouldn’t be a way that it could be 12 months. There’s not really a path that way. We expect a pretty straightforward review. The ID has CKD in their label or matching the label of the IV. We did a PK study that matches the label of the IV — the PK of the IV. So we think it’s a pretty straightforward review. And as I said before, we’re excited. Steve, do you want to talk about…

Steve Parsons: Yes. Yes. Well, we’re not negotiating for CKD hit at this stage. Payers don’t really want to do that. But we do know, we have pretty good assurance that cirrhosis will be covered the same way it is for heart failure with CKD. It will be a simple prior authorization to label. And that prior auth means they have to be trying generic oral diuretics, and that’s just not working, before FUROSCIX would be approved for an acute intervention. So it will be essentially the same, PA to label, our label will have CKD, and it won’t be any more complicated than that.

John Tucker: There’s exceptions where the plans will start a review prior to approval. It’s pretty rare. It’s pretty rare, though, that they spend the time to really start reviewing a product or an indication prior to approval. Again, they do it with…

Steve Parsons: Those things are under review at the FDA, they’re more likely to — you have to final first.

John Tucker: Yes, exactly.

Naz Rahman: That was helpful. And just one last question. So I think you — in your prepared remarks, you said you plan on expanding the commercial force for FUROSCIX. Could you comment on what the magnitude of that expansion would be? And does — the impact of change impact your timing decision making there?