Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q3 2023 Earnings Call Transcript

Caroline Baumal: Thank you, Cedric. We are in close communication with the ASRS Rest Committee and with regards to cases. And as far as we are aware, there will be no update at the American Academy. But we did provide an update at the Retina Society and at the Academy this weekend in addition to the GALE data, we’ll be presenting some very meaningful microperimetry data as well as having a presentation on artificial intelligence imaging and photoreceptor preservation from our studies.

Phil Nadeau: And going forward should we expect an update on the rate like once a quarter or any sense of when you’ll provide update?

Caroline Baumal: Well we continue to remain transparent with physicians and everything that we receive is reported to the FDA as per regulations and if that rate changes, we will update the community.

Phil Nadeau: Great. Thanks for taking our questions.

Cedric Francois: Thank you, Phil.

Operator: Thank you. One moment for our next question and our next question is coming from the line of Derek Archila with Wells Fargo. Your line is open.

Derek Archila: Hey, good morning and thanks for taking the questions. May be just one on Europe. I guess, have your recent interactions with the EMA been on the application? And just in terms of the market opportunity, maybe this one’s for Adam, and do you think the overall adoption in the EU will be any different than the U.S.? Thanks.

Cedric Francois: Thank you so much, Derek. So EMEA is on track and has continued to be on track. As we’ve mentioned a couple of times in the past, this has really has been a labor of love over many, many years of preparing the physician community as well as the regulators as well as the payers in Europe and we’re very excited about being able to offer this product we believe next year, right. So Adam, do you want to maybe briefly talk about the adoption?

Adam Townsend: Yes, thanks, Derek. Thanks for the question. Yes, we are ready to go in terms of commercial and medical affairs infrastructure. So we’re ready in Germany, right. So we are good to go once we get feedback. 5 million GA patients worldwide, Derek, obviously about 1 to 1.5 in the U.S. so the rest is all ex-U.S., so it’s a very sizeable opportunity. As a nice little analogue, about 45% of sales of anti-VEGF drugs are ex-U.S., right? So it’s a sizeable opportunity for us. A few things to think about, obviously it’s a payer market and a health technology assessment market and highly likely that brand, for example again, branded anti-VEGF prices are about 40% to 70% discount to the U.S. anti-VEGF prices. Even with that metric, this is a sizeable opportunity and the teams really invested the time to get to know the key opinion leaders and we believe that being transparent as we were in the U.S., we’ve been with key opinion leaders and doctors, ex-U.S. We think that they have all of the information that they need and should we get approval, I think the doctors will be ready to go very quickly.

Operator: Thank you. One moment for our next question. Our next question is coming from the line of Eliana Merle with UBS. Your line is open.

Eliana Merle: Hey, guys. Thanks so much for taking the question. Just another on Europe. Can you just talk a little bit about how the review is going and the latest on your confidence on approval there? And then in terms of the feedback you’ve gotten from physicians in Europe relative to the U.S., maybe on safety and their perspective? And then any commentary on what we should expect in terms of the contribution to revenues next year from Europe. Thanks.

Cedric Francois: Okay, thank you, Ellie. Well, I’ll take the first one, then I will have Caroline speak about the doctors on safety in Europe and then Adam or Tim can talk about revenue. But again, European discussions have gone very well. As you all know, kind of correlation to functionality is very important in Europe. And as the data kind of comes together over time now also with GALE, that is something that we feel very good about. Caroline, on the doctors in Europe?

Caroline Baumal: Thank you. The KOLs in Europe are very well connected with the U.S. KOLS. It’s really a global community. Many of them were involved in the clinical study and have high confidence in our product and are familiar with its use. Also they are really data-driven and we have this visual function microperimetry data. We have key leaders in the U.S. but also in Europe on microperimetry who are impressed by this data and are looking forward to use of SYFOVRE.

Tim Sullivan: Thanks, Ellie. And then in terms of revenue, ex-U.S. is a very large proportion of potential future revenues. So with the anti-VEGFs we expect that we estimate that’s around 45% of total revenue. It’s actually more patients but less revenue per patient. In terms of next year however, while we expect approval in the first quarter, really that rollout becomes a sort of a country type by country basis, the first one being Germany. So we don’t expect a huge amount of contribution next year, but we do expect we will be able to recognize revenue right after approval, which we expect in the first quarter.

Eliana Merle: Great. Thanks so much.

Cedric Francois: Thank you, Ellie.

Operator: Thank you. One moment for our next question. And our next question is coming from the line of Akash Tewari with Jefferies. Your line is open.

Akash Tewari: Good morning. This is Ivy on for Akash. We have two questions. First, as you said in the prepared remarks on accounts receivables, which is found at $170 [ph] million this quarter compared to $7 million at year end. Could you maybe give us more visibility there? What’s the current inventory level at the distributors level? And the second is, I think someone already asked this, but today I think competitors also announced their fixed sales estimate of around $1.3 million to $2.6 billion, which seems quite conservative compared to numbers laid out in their proxy, which implies fixed sales of around like $4 billion in just the U.S. We’re just curious what do you think may have led to the changes in part for them on the GA market potential and has your view changed at all? Thanks.

Cedric Francois: Thank you so much for that question. I will hand it over to Tim and then Adam.

Tim Sullivan: Sure. The big change in accounts receivables relates to the fact that we have fairly extended but also market typical payment terms. So that receivable is primarily the distributors in particular the largest portion is for SYFOVRE. It’s typical for a launch in this space and we don’t expect any issues in terms of collections. So it’s just fairly typical and I think you’ll see that number increase slightly over time as sales increase. And then with respect to EMPAVELI, I think it’s hard for us to speculate why they’ve had that change. We obviously think this is a gigantic market and anything that they do, I mean if you look at their prepared remarks from what we saw based on their, they’re early in their launch and they’re still evaluating based on not only what they’re seeing personally, but also what they’re seeing from us and I expect you will see that number evolve over time.

Adam Townsend: Yes. And just to add to Tim’s, Ivy, it’s Adam. Yes, we truly believe it’s a large market, but it’s also a market which is driven by certain aspects of a good product profile, so flexible dosing, increasing effects over time. So within a large market, we truly believe we have a very competitive product. It’s an exciting opportunity to prevent and help patients vision over time worldwide. So we’re excited to go and get after that.

Akash Tewari: Thank you.

Operator: Thank you. One moment for our next question, and our next question is coming from the line of Annabel Samimy with Stifel. Your line is open.