No reclassifications were necessary for prior periods; however, it is important to note when reviewing trends in our operating expenses. And finally, our operating expenses do not yet reflect the ongoing efficiencies we expect from our restructuring due to severance and winding down of certain projects. We expect to realize these efficiencies beginning in 2024. As of September 30, 2023, we had $452 million in cash and cash equivalents. September and October demand provided us with a better view of the demand and sales trajectory going forward. Based on this and cost savings from our recent restructuring, we now expect our cash balance to fund our operations into at least the second quarter of 2025. I will now turn the call back over to Cedric for closing remarks.
Cedric?
Cedric Francois: Thanks Tim. This quarter was not without challenges, but we are now seeing a clear rebound in the growth and progress we accomplished earlier this year. We are on the cusp of expanding SYFOVRE’s reach in global markets alongside steady growth in the PNH market with EMPAVELI. We remain dedicated to delivering on our strategic priorities and creating long-term shareholder value. Let us now open the call for questions. Operator?
Q – Jonathan Miller: Hi, guys. This is Jon Miller on. Maybe now that you’ve had some more commercial experience through all of this speculative stuff, can you maybe update our assumptions on the difference between vials shipped and doses given and what proportion of doses are sitting in fridges at various places in your estimation? And then secondly, maybe on the etiology of vasculitis, do you have any early signs out of the needle switch at this point? Is that really making an impact in rate or are there any suggestions of a patient risk profile that might identify patients ahead of time? Has there been any motion on that front?
Cedric Francois: Hey, Jon, great to hear you. I’m going to hand the first question over to Adam and then I’ll take the second one.
Adam Townsend: Hey, Jon. So first things first, I think we’re extremely confident and pleased with the commercial execution and let me give you a few numbers. So obviously, 37,000 commercial vials in the third quarter and about 10,000 samples. All of these vials were shipped to physicians and we assume, based in our math, an average of about 1 to 1.5 weeks of demand vials sitting in a refrigerator. So we think we have over 100,000 injections since launch, about 50,000 patients being treated with SYFOVRE. I think it’s a really strong commercial execution. So hopefully that answers your question and I’ll hand back to Cedric for the second part.
Cedric Francois: Thank you, Adam. And then talking about etiology, so it is still too early, right? I mean we’re going to need probably another quarter or two to really understand whether the needle had an impact or not. That’s the most important metric here is that the rate of vasculitis is very low and stable, right. That’s something that’s over the past couple of months we’ve been able to track and of course it provides confidence to the physicians. So with more than 100,000 injections done in the real world, we are at a rate and continues to be at a rate of 0.01%. But it’s of course also important to look into which patients have significance and severe vision loss and there the rates are meaningfully lower than 0.01% on a per injection basis. And using that metric with 50,000 patients treated, you’re also still at a rate of 0.01%. So something that of course we hope to understand better in the future, but most importantly, stable and being followed over time.
Jonathan Miller: Thanks guys.
Cedric Francois: Thank you, Jon.
Operator: Thank you. And our next question coming from the line of Tazeen Ahmad with Bank of America. Your line is open.
Tazeen Ahmad: Hi, thank you. Good morning guys. I just wanted to ask you a question about the competitive landscape if I could and how you think it’s evolving. It looks like Dallas has reported $8 million for its first month on the market and they are projecting about $72 million for their full calendar year, which I believe ends in March. So can you just talk about what feedback you’re getting from field force about competition? Whether it’s increasing and where if anywhere you might be seeing patients switching? Thank you.
Cedric Francois: Thank you, Tazeen, great to hear you. Adam will take that question.
Adam Townsend: Yes, thanks Tazeen. So it’s interesting we hear firstly from analysts and investors a lot of surveys done with physicians where the sentiment that’s given back to us is that these physicians are bullish on iSURVEY. It’s different to what we hear in the field. It’s been relatively quiet in the fields. We’re not hearing a lot of noise, we’re really, really not hearing very much from the field. And I think if you look at our first three quarters which is in line with their fiscal year reporting, we were $160 million in the first three quarters of launch. So that’s a hugely successful launch. I think we are going to be laser focused on executing our plan, which is to continue to talk about increasing effects over time, the strong clinical profile, long-term efficacy, dosing flexibility and just to say the vast majority of physicians are using SYFOVRE every six to eight weeks.
We have strong payer coverage. Our J-code in October. I’m very confident that we will continue to show positive growth with SYFOVRE. So we’re going to be focused on our plan. We execute our plan. I think we’ll do incredibly well.
Tazeen Ahmad: Okay and thanks Adam. And maybe as a follow up, Apellis is going to be showing in 24 months I believe at the AAO Conference this week, this weekend. And as it relates to every other month, what are physicians telling you about what they want to see on curve separation for every other month’s dosing?
Cedric Francois: Thank you, Tazeen. Caroline would you like to answer that?
Caroline Baumal: Thank you. Physicians would like to see increasing effects overtime, I think that’s very important for them. And at the American Academy of Ophthalmology this weekend we will be presenting our GALE data, the first year of the extension study where our patients have received, some of the patients have received three years of continuous pegcetacoplan therapy. I think physicians will be impressed by our data and they also are impressed by the science that’s behind pegcetacoplan. They like the flexibility with dosing with monthly and every other month dosing being meaningful and three years of data. And actually the first patient will be — patients will be rolling out of GALE this December, that’s five years in the clinical study with continuous pegcetacoplan treatment. So we’re really proud of that data.
Tazeen Ahmad: Okay thank you.
Cedric Francois: Thank you, Tazeen.
Operator: Thank you. And our next question coming from the line of Anupam Rama with JPMorgan Your line is open.
Anupam Rama: Hey, guys. Thanks so much for taking the question. So in terms of use of SYFOVRE, back in the summer you talked about this one third, one third, one third breakdown when it comes to utilization, what is that breakdown now and what are you seeing from those that were maybe previously in that one third bucket that was on the sidelines or you’re waiting for more information? Thanks so much.
Cedric Francois: Thank you, Anupam. Adam?
