Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) Q1 2024 Earnings Call Transcript

William Peters: Yes. So the plan — so right now of the other 25 countries where we distribute BAQSIMI, 3 of them, we’ve picked up in Europe. The other 21 countries around the world, we plan to pick up and that’s once Lilly has depleted all of their labeled inventory and we have Amphastar labeled inventory ready to go. So we’re working on that. I think a lot of those countries will happen. We think a majority of those companies will probably convert in the third quarter but we’re looking for most of those in the June to August time frame. And then there will probably be a couple of lingering countries that don’t convert until the end of the fourth quarter, though.

Timothy Chiang: Okay. And just one last question, if I may. Epinephrine, I mean, this product — I think you’ve had your best quarter to date with epinephrine sales in the first quarter. Do you expect this type of continued year-over-year growth figures for the next couple of quarters going forward?

William Peters: It’s hard to keep that kind of growth up because I think we’re maxed out on what we’ve been able to produce this quarter, so it’s a combination of us — right now for the prefilled syringe presentation of that product, we are the only company in the country making that for the hospital market. So we’re making as much as we can and we’re at our capacity for that product. So I really don’t see it going any higher than it is right now. And I see it probably continuing at this level for at least another quarter, if not longer.

Operator: Our next question is from Jason Gerberry with Bank of America.

Pavan Patel: This is Pavan Patel on for Jason. Two questions from us. The first is to what extent is mix driving growth in terms of the market moving from single-use generic kits to brands offering 2 units? Like, what’s the product shelf life? And does that create a risk that patients might take longer than expected to work down their inventory? And then my second question is that insulin use in type 2 diabetes has declined. And we generally hear from physicians that these glucagon rescues make more sense for type 1 diabetics versus type 2, who can manage their blood sugar. Do you see type 2 diabetes as a meaningful area to expand BAQSIMI. And is that embedded in your peak sales outlook for BAQSIMI?

William Peters: Yes. So as far as the expiration goes, most of these products have a 2-year shelf life from the date of manufacturing. So that usually takes a little while to get released and then into the wholesale channels, then to the retail, then to the customers. So generally, the customer, depending on when they get it, has 12 to 20 months of shelf life from when they buy the product. And I’ll let Dan tell us little bit about type 1.

Dan Dischner: Yes. I think as far as type 2 diabetic patients, I think that’s true and I would agree that bulk of the percentage of people with type 1 that are needing these glucagon products is higher for type 1 as compared to type 2. Just partially, it’s a compliance issue. Type 1 diabetics, because they’re dependent on the insulins, are more compliant than type 2. And so with type 2, there’ll be less utilization, as a percentage of those — of that population for the use of these glucagon products. But I think with that population getting more educated and getting more into the health care system with some of the GLP type products, I think that should increase as they get more into the health care system.

William Peters: And then as far as our forecasting goes, yes we knew about the GLP-2 when we bought the product. And we ran multiple scenarios on this. And our base case scenario, I think, is relatively conservative, the one that we forecast and we keep in our presentation. So I think we’re very comfortable in getting to that even with the marketing — the market changes that people have seen over the last year.

Operator: Our next question is from Serge Belanger with Needham & Company.

Unidentified Analyst: This is John [ph] on for Serge. Just a couple of quick questions. First, regarding the insulin biosimilar AMP-004. You mentioned you’re going to be refiling it in the second quarter. Do you guys have any context for any feedback that you’ve gotten from the FDA thus far regarding how many rounds of review you might expect for this product? And then generally speaking, can you give a little color on the overall market opportunity that 004 might enter into? And then just on the side, regarding the patent listing challenges from the FTC reported about a week ago now. I believe you have — if I’m correct, you have, inside, 30 days to either dispute the letter or amend your patents. Can you give a little color on the process that you guys are going through and what you might expect over the coming weeks?

Dan Dischner: Yes. For your first question regarding the insulin product, we don’t — the agency hasn’t shared with us how many rounds they would expect. But this is our first biosimilar biologic product that we filed an application for. What I can say is that the dialogues that we’ve had with the agency and the document that they gave us where they asked us to resubmit our application, the amount of comments that we received on that far exceeded what our hopes would be in the sense that it wasn’t as simple as, “This is the minimum that you could do.” They actually gave what I would characterize as a very solid attempt to give us some very positive feedback about items that they’d also like to see in the application that, in my mind, is almost as though this would prevent us from having a cycle — an additional cycle.

So I think that from the FDA’s desire, based upon that, I would expect them to be very forthcoming in this and to kind of help to — when they do give, if there are additional cycles of feedback that they would give, would be very clear to really help us. It seems like this is a product — based upon the years of dialogue that we’ve had with them, it seems like this is a product that — they realize the capabilities that we have and the technologies that we have that they are very invested in helping us with this application. And as far as the sales opportunity for OOI, it’s over a $4 billion product. There’s over 41 million units of the product sold a year. So we see it as a really big opportunity for us in the long run. Definitely, it is — we’ll be at a lower price point than what they’re signing now.