Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q1 2024 Earnings Call Transcript

Colleen Kusy: Great. Good morning. Thanks for taking our questions. Adam, you commented on a slight dip in February. Is that a factor of every eight-week dosing or kind of what you think was driving that slight dip? And then can you just comment on inventory in the quarter? I think our math is showing as a slight drawdown in the quarter, but could you just comment, please?

Adam Townsend: Hey, Colleen. Yes. So, yeah, I mean, obviously February was a shorter month, and I think there’s always a little bit of seasonality in January, February, and March that we’ve seen. But we picked straight back up in March and continue to see growth into Q2. Now, we previously announced mid-February 40,000 doses. And just add a little bit of context to your question. That was within the first seven weeks of the 13-week quarter. We then saw an additional 37,000 doses distributed across the remaining six weeks. So that just shows you a little bit about the timing of those type of announcements and the seasonality within. What was the second part of your question? Just. I didn’t catch it.

Cedric Francois: Drawdown of inventory.

Colleen Kusy: Yeah.

Adam Townsend: Drawdown of inventory. We did see certain wholesalers draw down inventory and we — that’s again normal as part of the seasonality of the month.

Colleen Kusy: Great. Thank you.

Operator: Thank you. One moment for our next question. Our next question comes from Philip Nadeau with TD Cowen. Your line is now open.

Philip Nadeau: Good morning. Thanks for taking our questions. One from us and a follow-up. On the future trends, there seems to be a lot of focus among investors on what Izervay is going to do to your growth in future quarters. I know you’ve expressed confidence that you’ll continue to grow given the size of the market. I think people are debating whether current consensus is achievable. It looks like for Q2 and Q3, consensus calls for 11% to 12% growth quarter over quarter, in both those quarters. It seems like a meaningful deceleration compared to what you showed here in Q1. So is that reasonable? Is that conservative? Is that aggressive, based on your expectations and what you’ve seen thus far in Q2?

Cedric Francois: Thank you so much, Phil. Adam?

Adam Townsend: Yes. Thanks, Phil. So 20% growth, Q1 versus Q4, I think is a very positive thing. And we continue to see growth into Q2, strong growth. We don’t comment on what that growth will look like for the full quarter. We’re excited to be able to represent that at our next earnings call.

Philip Nadeau: That’s fair enough. And then just one follow-up on the EU. Should you get a negative CHMP opinion in July? Do you still now have the appeals process available to you? Could you go down the same road that you thought you were going to go down back in January once this review is over?

Cedric Francois: Thank you, Phil. Yes, we can. So, as I mentioned before, the process will be longer, but we believe that the odds of approvability stay the same.

Philip Nadeau: Perfect. Thanks for taking our questions.

Cedric Francois: Thank you.

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

Ivy Wang: Hello. Good morning, this is Ivy on for Akash. We have a couple of quick ones on SYFOVRE. So first is on safety. What’s your current hypothesis on the causes behind the cases? Have you done any testing on peg antibodies? And then on the competitive landscape, If there’s no more retinal vasculitis cases for either way over the next two quarters, how would your internal market share projections shift? And finally, it’s for your branded DTC campaign. What’s the ROI you are targeting at? And also like what’s the spend associated with this campaign for this year? Thanks.

Cedric Francois: Thank you so much and wonderful to hear you. So, first of all, on the hypothesis, again, as we’ve discussed before, it is pretty remarkable that there is this first injection phenomenon, right, from an immunological perspective. Our leading hypothesis, as you correctly mentioned, is indeed around polyethylene glycol. That is work that we will continue to do to further explore. Now, for our competitor, we will see where things land. I think what is really important for us is that the rate of vasculitis is extremely low and stays extremely low is a first injection phenomenon. And the efficacy is something that, of course, really stands out for SYFOVRE versus our competitor, which — at the end of the day, we think will be the most important.

All of this stands in the background, of course, of this enormous market that geographic atrophy represents because of the enormous amount of patients that are unfortunately affected by this disease. So, now as it relates to the DTC campaign, let me hand it over to Adam.

Adam Townsend: Yeah, Ivy. And I’ll just add on to what Cedric said, right? Our market leadership is driven by our strong efficacy, well-documented safety, flexible dosing, and the unmatched data set that holds all of that up. So that’s, I think, incredibly important for the rest of the year. And I think people choose GA drugs for their incredibly strong efficacy. As to DTC, so our DTC campaign is actually live now on TV. So our new campaigns are streaming. We’re investing in this campaign because we think it has an incredibly strong positive return on investment. It will drive more patients into retina specialist offices, and those patients will see our ad and ask for SYFOVRE. And then the four pillars of what we think builds up a great GA drug come into play there where the physician will have that conversation with those patients and hopefully put those patients on.

As Cedric said, this is a large market and all of our DTC activities will push more SYFOVRE patients into the market.

Ivy Wang: Thanks.

Operator: Thank you. One moment for our next question. Our next question comes from Ellie Merle with UBS. Your line is now open.

Eliana Merle: Hey, guys. Thanks for taking the question. Just one quickly on expenses and profitability. Just given you expect expenses to be less in ’24 versus ’23, and with SYFOVRE is growing, how are you thinking about when you might reach profitability and what are the potential swing factors there? And then just a second one on your pricing strategy is what are your expectations for gross to net in the second quarter? And do you expect any uptick in gross to net or in your use of samplings in the second quarter? And just walk us through how you’re thinking about your pricing and contracting strategy. Thanks.

Cedric Francois: Thank you. Ellie. Great to hear you. Tim.

Tim Sullivan: Sure. Thanks, Ellie. So the good news is we’re in a very strong financial position, and we’ve previously said that our cash and our projected revenues are sufficient to fund our operations for the foreseeable future. From an expense perspective, on a quarterly basis, our Q4 2023 expenses were lower than our Q3 2023 expenses by about 7%. And then taking into account the one-time charge for cold agglutinin disease, this quarter, they would have been down a further 5% or so. So we have seen that decrease in operating expenses and we continue to believe that our expenses will be lower in 2024 than in 2023. On the top line, you can see that we’re also growing nicely and that combination, we’ve said, will obviously allow us to fund our operations. But we don’t actually guide on when we will become profitable.

Operator: Thank you. One moment for our next question. And our next question comes from Annabel Samimy with Stifel. Your line is now open.

Annabel Samimy: Hi, all. Thanks for taking my question. I want you to — I want to ask about the referrals from ophthalmologists. Is that Just started or retinal specialists were working with their own patients? And with this DTC campaign, can the retinal specialist handle the number of — the volume of referrals that are going to be coming in if the referrals have just started? And then on the competitive landscape, obviously, Izervay has been our for a little bit now. Now they have a J-Code, but I mean, instead of thinking about it as a competitive headwind, do you actually think that having a competitor out there is creating more of a tailwind for the whole entire space. And maybe you can speak to that and what dynamics you’re seeing there. Thanks.

Cedric Francois: Thank you so much, Annabel. I’ll hand it over to Adam.

Adam Townsend: Yeah. Thanks, Annabel. So at the moment, referrals are quite low. And as you said, right, this is a very large market. So the vast majority of retina physicians are treating patients that they already had a relationship with or were on their books, so to speak. And we believe the DTC campaign will start to push those patients that they don’t have and those referrals from ophthalmologists and optometrists in to get treatment. So that’s the core aspect of our DTC. The feedback we hear from retinal physicians is that they have the capability of accepting many, many more patients. And I don’t think it’s remotely a problem for them to treat those new, additional patients. And that’s been consistent feedback we’ve got as we progress through the launch.

Now, competition is healthy and competition does grow an incredibly large market. And I think the team that we have in the field is laser-focused on executing because we believe that we have the strongest product profile out there in this large and growing market. So I do think market growth driven by competition is a great tailwind for us and I think we’re primed and have the best drug to be able to capitalize upon.

Annabel Samimy: Great. Thanks.

Operator: Thank you. One moment for our next question. Our next question comes from Francois Brisebois with Oppenheimer. Your line is now open.

Francois Brisebois: Hi. Thanks for the question. Just quickly two here. So in terms of the 2000 sites that you’re now in, do you discuss — you discussed some that are only Izervay, some that are only SYFOVRE but do you discuss how many sites you will ultimately like to get into? What’s your market penetration in terms of sites that make sense? Thank you.

Cedric Francois: Thank you, Francois. Adam?

Adam Townsend: Thanks, Francois. So yes, we’re in over 2,000 sites that have chosen to use SYFOVRE. And as I said before, some of those sites are very SYFOVRE-dominant. We believe that there are over 3,000 sites initially that we want to target. So we still have an opportunity for growth when it comes to sites. And as I said, my very nerdy metric of more than double-digit new accounts using SYFOVRE for the first time every week since launch continues. So that shows you that we’re making impact. It’s a big market with a large prescriber base.