Apellis Pharmaceuticals, Inc. Q3 FY2025 Earnings Call

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals Third Quarter 2025 Earnings Conference Call. Please be advised that today's conference is being recorded. I would now like to turn the call over to Eva Stroynowski, Head of Investor Relations. Please go ahead.

Good morning, and thank you for joining us to discuss the Apellis' Third Quarter 2025 Financial Results. With me on the call are Co-Founder and Chief Executive Officer, Dr. Cedric Francois; Executive Vice President of Commercial, David Acheson; Chief Medical Officer, Dr. Caroline Baumal; and Chief Financial Officer, Tim Sullivan. Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now I'll turn the call over to Cedric.

Thank you, Eva. Before diving into our third quarter results and portfolio progress, I want to briefly highlight the unmet need that Apellis set out to tackle and why we are uniquely positioned to address that challenge. Apellis is a commercial stage biotech company targeting the overactivation of the complement system, an innate defense mechanism in the immune system that protects the body from acute infection and illness. However, when complement is chronically unregulated, there can be a devastating effect on one's health, driving a broad range of serious, often life-threatening diseases. Most approved complement-targeted therapeutics inhibit at C5, a downstream protein in the complement cascade. By only blocking this target, C5 inhibitors do not affect the upstream activity that drives inflammation and tissue damage. Similarly, inhibitors of Factor B act earlier in the cascade and narrowly, reducing alternative pathway amplification but allowing classical and lectin pathway activity to persist, leaving some disease activity unchecked. Apellis' science is founded on a simple but powerful idea to address complement-driven diseases at their source by targeting C3, the central hub where all complement pathways converge. By doing this, we take a fundamentally different approach that enables comprehensive disease control at the root cause. For decades, the prevailing view was that C3 could not be effectively modulated because of its central role in immune defense. Apellis solved this challenge by engineering pegcetacoplan, a first-in-class C3 inhibitor that controls overactive complement while preserving essential immune function. The result is both a technological feat in drug design and a transformative clinical advancement for patients. This vision is what sets Apellis apart. We have mastered our core technology and redefined complement therapeutics. The scientific advantage underpins our success to date. Having now translated decades of innovation into two approved medicines across four serious diseases, Apellis is a commercial stage leader with a truly differentiated C3 platform. SYFOVRE is the first-ever treatment for geographic atrophy, having shown robust efficacy in slowing disease progression in the broadest patient population. EMPAVELI has demonstrated best-in-class hemoglobin improvement in PNH and the ability to completely clear C3 deposits from the kidney. Together, these achievements underscore our unprecedented clinical innovation and strengthen Apellis' competitive edge in complement science. Turning now to our business results. The third quarter was a period of further progress where we continued to build on our strong performance. A key milestone was the FDA approval of EMPAVELI for the treatment of patients 12 years and older with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis or IC-MPGN. This approval expands the addressable market for EMPAVELI by approximately 5,000 patients and marks a breakthrough therapy that delivers meaningful results across the trifecta of key disease control measures, including proteinuria reduction, eGFR stabilization, and substantial clearance of C3 deposits. With a broad label in hand, we are well positioned for launch in a space where physicians consistently note that efficacy will drive treatment decisions. David will share more on the launch progress shortly. Moving to SYFOVRE. Geographic atrophy is a devastating disease that progressively and permanently robs patients of their vision. Unfortunately, in managing GA, many retina specialists have adopted a wait-and-see approach despite SYFOVRE's well-established clinical profile that demonstrated robust, sustained, and increasing benefits with every other month dosing. Because of this, only about 10% of patients diagnosed with GA are treated with complement inhibitors today. In the near term, we expect a period of steady, measured injection growth with the next inflection in growth to be driven by new tools and targeted market education initiatives that we plan to bring to market over the next 12 to 18 months. We believe these initiatives will reaccelerate the adoption of complement treatments and grow the overall GA market. Overall, our focus remains on leveraging our expertise in complement-mediated diseases to positively affect the lives of people living with serious illnesses. With this in mind, we continue to maximize our market opportunities for EMPAVELI, drive expansion for SYFOVRE, and advance our pipeline. I will now hand the call over to David for an update on our commercial activities.

Thank you, Cedric, and good morning, everyone. I'll start with EMPAVELI and the recent approval in C3G and primary IC-MPGN. We are now two months into the launch, and I'm very pleased with our progress so far. Feedback from the nephrology community has been outstanding, and we are carrying that momentum into Q4. In the U.S., we estimate there are approximately 5,000 C3G and primary IC-MPGN patients. Notably, EMPAVELI's broad label makes it the first and only treatment approved for a comprehensive list of patient populations, including adult patients with C3G, adult patients with IC-MPGN, pediatric patients with C3G, primary IC-MPGN patients aged 12 years and older, and patients with post-transplant C3G disease recurrence. EMPAVELI is the only approved therapy for approximately two-thirds of this 5,000 patient population, and we believe it offers highly differentiated efficacy for the other one-third where patients have an alternative. Together, the broad label and the strong clinical data position the launch of EMPAVELI for the long-term success. For the first time, patients can be treated with a first-in-class C3 targeting therapy and the only complement therapy that has demonstrated its ability to preserve kidney function by controlling all three markers of these diseases, including proteinuria reduction, eGFR stabilization, and substantial clearance of C3 deposits. EMPAVELI is delivered through our compact single-use on-body auto-injector. Patients can self-administer in the comfort of their own home without ever seeing a needle. Early feedback from the market has been exceptionally positive, highlighting its ease of use and the convenience of the twice-weekly dosing. The PK profile of EMPAVELI allows patients the flexibility to take treatment on their own terms, avoiding twice-daily dosing required by the oral alternative. Ahead of the launch, we scaled our field-based teams to approximately 100 people, ensuring coverage of every U.S. nephrologist managing these patients. Our extensive prelaunch engagement with physicians and patient identification efforts have built a strong foundation for a successful rollout. As communicated in our approval call, the launch metric that we will be reporting early in launch is patient start forms. Through the end of September, we received 152 patient start forms for EMPAVELI. Included in this number are the approximately 50 patients from our expanded access program, or EAP, who are in the process of converting over to commercial drug. We remain on track to have these EAP patients on commercial drug by the end of this year. As a reminder, it generally takes 4 to 6 weeks for a patient to start treatment. We see opportunities to potentially accelerate this time frame as we gain more experience on our launch and as payers' policies are updated. During the quarter, we made meaningful inroads with high-volume prescribers and are confident in the continued growth of adoption. Of the 20 most influential and high-volume accounts in the space, 19 have a REMS certified prescriber, and the majority of these centers have submitted start forms, clear evidence that our launch efforts are translating into real-world adoption across priority accounts. On the access front, we are encouraged by payers' recognition of the value of EMPAVELI in C3G and primary IC-MPGN and by the speed at which these patients are successfully gaining access. Furthermore, our dedicated ApellisAssist team is closely working with patients and prescribers to navigate the expected prior authorization requirements, to minimize delays and support a smooth start to therapy. These have been incredibly encouraging early weeks for a rare disease launch, and we are excited by the strong engagement from both physicians and patients. We are learning a great deal about prescriber habits. And once physicians are educated on the differentiated profile of our therapy, they quickly become strong believers in its disease-modifying potential. We believe we have worked through most of the onetime wave of early adopters and EAP patients and expect to receive 225 cumulative start forms or more by the end of this year. Looking ahead, we are confident in the long-term growth potential of EMPAVELI as awareness deepens and patient access continues to expand. Moving on to SYFOVRE. We are encouraged to see continued market leadership with a total estimated injection growth of 4% during the quarter, in line with our expectations. SYFOVRE maintains its leading position, accounting for an estimated 52% of new patient starts during the third quarter and more than 60% of the overall market. As commercialization matures, we've moved past the early adopter phase and expect steady measured injection growth for the near term. Importantly, we believe that the long-term market opportunity remains significant with blockbuster potential. Today, only about 10% of patients who are diagnosed with GA are being treated. And specifically for retina specialists, on average, just one in five patients with GA in their practice are treated with a complement inhibitor. This leaves substantial room for growth by expanding the total number of prescribers and by increasing adoption within existing practices. To drive this opportunity forward, we are focusing on disease awareness and education, laying the groundwork for the next wave of growth through initiatives that include engaging with early career retina specialists who seek a disproportionate number of new patients, enhancing education around the importance of early intervention and maintaining patients on treatment and refining our messaging to better equip field teams in their outreach and discussions. I will now hand the call over to Caroline to share additional color on these initiatives and provide an update on our pipeline.

Thanks, David. Let me start with SYFOVRE and geographic atrophy. As the only approved drug that binds to C3, the central protein of the complement cascade, SYFOVRE potently inhibits the damaging downstream effects of complement overactivation, forming the basis of its strong clinical profile. Patients with GA are on an irreversible path to blindness. As Cedric and David mentioned, there is ample opportunity to advance the understanding of GA within the treatment community and to instill the urgency to treat patients early to save retinal tissue. To support this, we are developing artificial intelligence tools that will help physicians gain a better understanding of what GA patients experience as well as the benefit of treatment with SYFOVRE. We are also working to provide more convenient administration through the development of a prefilled syringe. We believe that both of these key initiatives will broaden the prescriber universe within the overall GA market and drive higher utilization of SYFOVRE over time. Turning now to EMPAVELI in C3G and primary IC-MPGN. The treatment community's response to the recent approval has been incredibly positive, and we are confident that it will be the preferred treatment option for these patients. We're excited to share seven abstracts at next week's American Society of Nephrology meeting, further demonstrating EMPAVELI's profound and durable benefit and underscoring our commitment to the rare nephrology community. Building on this momentum, we are expanding EMPAVELI's development into two other rare kidney diseases, primary focal segmental glomerulosclerosis, or FSGS, and delayed graft function, or DGF. Similar to C3G, FSGS is a rare kidney disease that progresses to kidney failure within 5 to 10 years for about half of patients. DGF is a complication in kidney transplantation that negatively affects the long-term survival of the kidney and the overall patient outcomes. The complement pathway plays a significant role in both diseases, and there are currently no FDA-approved therapies for either. We are well underway with our planning activities and expect to initiate pivotal trials in FSGS and DGF by the end of the year. With that, I'll now turn the call over to Tim for an update of the financials.

Thank you, Caroline. Total revenue for the third quarter was $459 million, including the $275 million upfront payment from Sobi in connection with the Aspaveli royalty purchase agreement. SYFOVRE net product revenue for the quarter was $151 million. We delivered approximately 101,000 doses of SYFOVRE in the quarter, including 86,000 commercial doses and 15,000 free goods doses. In line with our expectations, we saw a 4% sequential growth in overall total injection demand during the third quarter, driven predominantly by free goods. While we are encouraged by the continued growth in total injections as a leading indicator of demand, we did see an approximate $15 million headwind to our reported revenue due to the elevated use of free goods, which was slightly higher than our expectations. Through the first three quarters of the year, we estimate that free drug has been a nearly $40 million headwind to SYFOVRE revenue. Looking ahead to the fourth quarter, we continue to expect modest SYFOVRE total injection growth within the low to mid-single-digit range. Turning to gross to net dynamics. Adjustments during the third quarter for SYFOVRE remained within the low to mid-20% range, consistent with our guidance through 2025. As we move into Q4, we expect gross to net to trend slightly above the prior range. This reflects the normal step-wise pattern of gross to nets over time with modest degradation and some quarter-to-quarter movement that's typical in the buy-and-bill market. Importantly, this reflects expected dynamics rather than a structural shift, and we remain confident in our pricing and access position heading into 2026. From a channel perspective, we anticipate a modest channel build during the fourth quarter, consistent with seasonal patterns expected at year-end. That said, we continue to target stable inventory levels quarter-over-quarter, and we'll provide further commentary during our year-end update. Taken together, our current view is that the fourth quarter SYFOVRE revenue will be broadly in line with what we recorded in the third quarter. Looking beyond these short-term dynamics, as Cedric and Caroline mentioned, we have several compelling opportunities that are largely within our control to reinvigorate SYFOVRE's growth over the next 12 to 18 months. We remain confident in the meaningful long-term potential of SYFOVRE and look forward to updating you on our progress in bringing these initiatives to fruition. Moving now to EMPAVELI. Total net product revenue across indications, which includes PNH, C3G, and primary IC-MPGN, was $27 million during the third quarter. We believe we are now through most of the initial wave of early adopters. And looking ahead, we expect the nephrology opportunity to normalize into a gradual ramp. Turning to expenses, we've maintained a highly disciplined approach to cost management, prioritizing the commercialization of SYFOVRE and EMPAVELI while continuing to fund the next phase of innovation for Apellis. Operating expenses were $235 million in the third quarter, down from $244 million for the same quarter last year. We continue to expect our full-year operating expenses to be in line with the OpEx levels we saw in 2024. We ended the quarter with $475 million in cash and cash equivalents, supported by the $275 million upfront from our Sobi royalty transaction this quarter. Our strong cash position gave us the flexibility to discontinue factoring during the quarter. As a result, we now carry the incremental balance in receivables on our balance sheet rather than in cash, and we expect to realize cost savings of approximately $5 million on a go-forward annual basis. We continue to expect our cash position will be sufficient to fund the business to sustainable profitability. And with that, I will now turn the call back over to Cedric.

Thank you, Tim. We have made important progress in 2025 to date. We achieved our third approval in just four years, bringing a first-in-class C3 treatment option to people living with C3G and primary IC-MPGN, many of whom had previously been living without any available options. Early feedback across the patient and nephrology communities has been enthusiastic, reflecting recognition of EMPAVELI's compelling efficacy profile and its value as a new treatment option. Additionally, SYFOVRE continues its market leadership and delivers a durable, meaningful revenue stream with opportunities for renewed growth over the long term. Combined with the cash from our Sobi deal in June, we have made steady progress on our path towards profitability. We look forward to building off the solid foundation we have laid for ourselves in the fourth quarter and into 2026. And with that, I'll turn the call over to the operator for questions and answers.

Our first question comes from Jon Miller with Evercore ISI.

Congratulations on the progress and the strong C3G launch. I have a question about that. Do you still anticipate that, beyond the initial group of patients you mentioned, the kidney indication will take time to penetrate? It seems this has been a consistent view from you and your competitors. Do you expect this situation to persist, or could your strong presence in leading practices suggest that the launch will be quicker than expected?

Thank you, Jon. Great to hear you. And I will hand that question over to David.

Jon, thanks for the question. Appreciate it. So first of all, we're really excited about where we are with the launch for EMPAVELI and C3G and primary IC-MPGN. The team has done a great job. And I do suspect as we get through the end of this year that the bolus that we had talked about will be through that, and you'll see steady, consistent growth going into next year. That's our expectation.

Our next question comes from the line of Anupam Rama with JPMorgan.

Just a quick one on SYFOVRE and on sampling. I think samples are on the higher end of this 10% to 15% range that we've all previously talked about. Should we expect this to now be more stabilized? Or is there a chance that this continues to creep up as you expand the market?

Anupam, great hearing you. Again, I'm going to hand that over to David.

Anupam, thanks for the question. So a couple of things real quick. We definitely review where we are with samples in the PAP program or free goods consistently to make sure that programs are being utilized the way that we want them to be. Also, though, we are, as you know, as a company, very in tune to making sure patients have access to products. So as things continue to grow, we'll have programs available for patients.

Our next question comes from the line of Steve Seedhouse with Cantor.

Just wanted to ask a few specifics on C3G. So first, can you break out just of the 150-odd patients, how many are C3G, how many are IC-MPGN pre- versus post-transplant, adult versus adolescent? And then also, do you know if anyone has switched from Fabhalta to EMPAVELI? And do you have a sense of your market share in C3G, just how many patients are on Fabhalta versus EMPAVELI?

Thank you, Steve. Great question. This is David. So you're right, we have 152 start forms, roughly 50 of those came through our EAP program. Consistently to label, we've seen start forms come through across the broad label, which is positive and for both indications. And we are seeing Fabhalta switches as a result of the information we've gotten from physicians as a result of our efficacy, in some cases, some tolerability and the ability for them to dose twice weekly with EMPAVELI versus twice daily with the competitive product.

Our next question comes from Yigal Nochomovitz with Citigroup.

So this is also a specific question on the launch. I think, David, you mentioned that 50 of the patients are in the process of converting to commercial drug. These are the ones rolling over from the clinical trials. It's just not clear. Are those actually on drug at this point? Are they still in process? And then the incremental other 102, could you just comment on what fraction of those have started EMPAVELI and approximately how long they've been on the drug since the end of July?

Yigal, thank you for the question. So you're correct. There's 50, roughly 50 patients on EAP. Our goal is to make sure all of them make it to the commercial product by the end of the year. And of the rest that have come in for new start forms, we are still working through the process with many of them. Remember, it takes 4 to 6 weeks for those patients to typically get from start to finish and get product. And that process is also being worked out as we move through the end of the year.

Our next question comes from the line of Salveen Richter with Goldman Sachs.

This is Elizabeth on for Salveen. Just one from us on that 4- to 6-week time frame from start to finish of getting product of EMPAVELI to treatment. When do you think we could start to see kind of an acceleration there? And what do you think that could normalize as?

Yes. Thank you very much, Elizabeth. So a couple of things to keep in mind. That's typical for most rare disease launches, in particular, where you have a REMS and vaccinations, and the start form that has to go in from a physician. The other thing that we're continuing to work through is the policies that are being written at the payer, which also takes some work early on in the process to make sure that, that transition from 4 to 6 weeks comes down to less than that period. So we're working through that now, and we'll have details as we move forward.

Our next question comes from the line of Akash Tewari with Jefferies.

This is Kathy on for Akash. So SYFOVRE rev stayed flat at $161 million quarter-over-quarter and induction growth was 4%. So one, do you see this as a floor for SYFOVRE before other components like long-term efficacy data or PFS come into play? And then two, when can we assume a return to growth for SYFOVRE? Or do you think it stays at this level given you're not assuming patient funding gets resolved near term?

Thank you, Kathy. This is Tim. From a growth perspective, we are optimistic about the underlying demand growth of 4% this quarter. As we noted in our prepared remarks, most of this increase in demand was driven by free goods. This headwind has been a challenge for us over the past three quarters, totaling approximately $40 million. Looking at the long term, beyond these immediate challenges, as Cedric and Caroline highlighted, we have several promising opportunities to boost SYFOVRE's growth, including the prefilled syringe, and we will provide more details on these at the beginning of the year.

Our next question comes from the line of Colleen Kusy with Baird.

Congrats on the progress. You spoke to some learnings of prescribers' habits in C3G and IC-MPGN at this early stage of launch. Can you elaborate on that a little bit and what the implications are for this launch?

Yes, this is David. Thank you, and I'll now turn it over to Caroline for some insights on the medical aspect. I can share that we're very pleased with our open label, and we've seen patients who meet all the indications for both uses in the label, which is promising. Currently, we're focused on ensuring that we provide the necessary education and support to our top accounts while also engaging with all other accounts. This represents a new indication and product for everyone, and they're adjusting to it, but we're really excited about how the launch has gone so far.

And what we've been hearing from physicians is that they are excited about our data, the robustness of it, the reduction in proteinuria and our 52-week results will be presented at the American Society of Nephrology among other abstracts that we have highlighting the reductions in proteinuria.

Yes. Maybe one last thing here from me. This is Cedric. It's been really gratifying to see how well we kind of were prepared and understand the landscape. We're very happy with the demographics that we have calculated, the ramp forecast we've created. So it's gratifying to see the results from clinical trials translate in the real world in the way it is.

Our next question comes from the line of Ellen Horste with TD Cowen.

I'm on for Phil this morning. Congrats on the quarter. Just one question from us. On SYFOVRE, has there been any progress with the Good Days co-pay assistance charity? Is there any visibility on when and if it can be funded to FSGS patients?

Thank you for the question. This is Tim. We have made some progress in understanding that the largest group is accepting existing patients, but unfortunately, not new ones, which you can verify on the website. However, based on our guidance for this quarter, we do not anticipate any changes regarding the patient assistance organization.

Our next question comes from the line of Jade Momen with Stifel.

This is Diane. I have two questions. The first one is for C3G, IC-MPGN. In the one-third shared market with Fabhalta, how do you expect prescribers to approach that market? What type of patients are physicians starting with Fabhalta, and what types of patients would be preferred for EMPAVELI?

Thank you for the question. This is Cedric. I believe the efficacy profile established in the VALIANT trial across all tested patient populations is quite significant. We see this as an important factor for physicians who prioritize differentiated efficacy. With our broad label, we have the opportunity to approach various segments. We've previously mentioned that post-transplant patients are particularly noteworthy since most of them tend to relapse. While there is some time needed to initiate protocols, we are eager to assist this exciting group of patients. Additionally, we are focused on patients at risk of progressing to end-stage renal disease. Having pediatric patients included in our label, specifically those aged 12 to 18, is also appealing to the nephrology community.

And I got one more on SYFOVRE. It's been on the market for a couple of years now. And if you go by the patterns in wet AMD, we might start to see patients drop off at this stage. What are you seeing as far as persistence on treatment?

Compliant.

Thank you for the question. Well, with our every other month dosing, which is very in line with anti-VEGF treatments, we're hearing from our physicians that patients are being compliant with treatment, and there will be some long-term data coming out from our open-label extension next year.

Our next question comes from the line of Lachlan Hanbury-Brown with William Blair.

I guess one on SYFOVRE. I noticed the new patient share ticked down a few points this quarter. I was wondering if there's any underlying dynamic that changed in the quarter that drove that? Or is that just sort of noise fluctuating a few percentage points, and it's kind of reached a point of stability here?

Yes, thank you for the question. This is David. First, I want to express our confidence in our competitive position. Just to remind you, we are at 52% for new to brand prescriptions and over 60% for total prescriptions. It's true that we sometimes see fluctuations in new to brand prescriptions, but we are confident in the consistent numbers we are reporting today.

Our next question comes from the line of Derek Archila with Wells Fargo.

Maybe just two from us. First on SYFOVRE. I guess how do you think about prefilled syringe, the checks that we've done on that, it seems like docs would be pretty enthusiastic. So when could that be made available? And how do you think that changes the growth trajectory? Is it more shifting share or expanding the market? And then I didn't know if I joined late, so just in terms of EMPAVELI start forms, any comments on trends post the quarter?

It's great to hear from you, Derek. Thank you. The prefilled syringe is very important for retina physicians as it enhances workflow and makes their workload more manageable. We have been developing a prefilled syringe, which is currently undergoing clinical testing. We are not providing a timeline for its availability due to competitive reasons, but we are pleased with its quality, which meets our high expectations, and we are excited about bringing it to market. Additionally, among the physicians treating patients with geographic atrophy, there are many who occasionally use SYFOVRE but do not do so regularly. I believe these physicians will be eager to incorporate more geographic atrophy patients into their practices. Furthermore, even those who have not yet adopted SYFOVRE as a treatment are waiting for the prefilled syringe to start addressing this challenging disease. Caroline, would you like to add anything?

Well, as a retina physician, I will say that it really increases convenience, consistency, and safety to have a prefilled syringe. And the requirements are very high for quality, and I'm really, really pleased with where we're headed with this. There was another part to the question.

So Derek, thank you again for your question. Regarding the launch perspective, we feel confident. While we provided guidance on the start forms in our prepared remarks, we are not offering any additional guidance beyond that. However, we look forward to updating you at the year-end call.

Our next question comes from the line of Biren Amin with Pipa Sandler.

This morning, Apellis just revised IZERVAY sales guidance downward by $200 million. And so they're clearly seeing headwinds in GA market growth. Given that data point and your low to mid-single injection growth that you project, do you feel it's due to undertreatment? And what shifts that dynamic with retina physicians?

Yes. I mean so I'll start. So I'll just confirm what you're saying, which is that we do see a significant headwind for these patients who are trying to get treated and want to get treated, but can't afford it. So it's had a huge impact on the market in general. And at least our discussions with retinal specialists suggest that many of them are not treating GA patients or not even having the conversation they should be having with GA patients because this has created a logistical as well as a financial headwind. I'm not sure. I hope that answers your question.

I think what can shift the dynamics with physicians also are multiple things that we're working on at Apellis. We're the science company. We have robust data. We're working on educating physicians using artificial intelligence, which they can also use for patients. We're working on a prefilled syringe, and we have multiple new things coming forward to impact physicians and patients.

Our next question comes from the line of Judah Frommer with Morgan Stanley.

Maybe just a couple of follow-ups. I guess on patient start forms for C3G and IC-MPGN, can you comment on just how they came in versus internal expectations? It sounds like they came in reasonably well. And then on just the sampling for SYFOVRE, any commentary you can make on how much of that is self-driven versus competitive dynamics on sampling?

Yes. Thank you very much. Regarding the expectations for C3G and IC-MPGN, as I mentioned earlier, this aligns closely with our predictions. We have high hopes for this, and we are confident about the demographics we have established. The figure of 5,000 is, in our view, a solid conservative estimate of the patients who could benefit from our product. As for your question about SYFOVRE, I apologize, but I am having trouble hearing you...

I can answer. It's on the samples in the free goods. So your question was, is there a competitive dynamic? I don't think that's necessarily the case. What we do know is if someone is reaching for a free good, that's true demand. It's a patient that wants to be treated. It's a physician that wants to treat the patient. And we have those programs in place and monitor them regularly to make sure that they're within the guidelines that we want to have followed, but they're accessible because patients that want to go on treatment, we believe, should be able to do that.

Our next question comes from the line of Ryan Deschner with Raymond James.

Can you remind us when the actual date EMPAVELI was first made available to patients for the C3G, IC-MPGN launch? And then also, do you have an update on the rough time line for a top line readout from the Phase II study for SYFOVRE and APL-3007?

This is David. I'll answer the first part of the question. We launched the product in the week of July 28. And I'll hand the other portion of the question over on 3007 to Cedric?

Yes. So thank you for that question. So the trial is enrolling. We're very excited about this trial. As a reminder, with 3007, what we do is combine SYFOVRE with a subcutaneous injection that is an siRNA product, which brings down the systemic levels of C3 by approximately 90%. And the objective there is to go from every two months to every three-month dosing and to then obviously, of course, see an outsized effect on the efficacy side. We're not guiding in terms of when that study will be completed. It's currently enrolling and has a one-year endpoint readout.

Our next question comes from the line of Douglas Tsao with H.C. Wainwright.

Tim, you mentioned there's an issue with some practices facing a lack of co-pay support, leading to a backlog or operational challenges. Is this related to the difficulties within the practice regarding the time it takes to process benefits and follow up with patients? Or is it more about patients having unrealistic expectations for starting treatment and then experiencing frustration when delays occur?

It's a complex situation for both physicians and patients. Determining who can afford co-pays and who cannot involves a significant amount of time and effort. There's considerable time lost for physicians during this process. As Tim mentioned earlier, we've observed a notable slowdown this year due to these factors, not only in the gastrointestinal area but also in wet AMD, where many practices have temporarily stopped accepting new patients to avoid engaging in these discussions. These challenges are obstacles we need to navigate, and we're committed to finding solutions. While we can assist practices with availability and access, the fundamental issues are beyond our direct control.

I'll also add that it particularly affects GA patients because there is a generic alternative in the wet AMD space. There is no generic alternative in the GA space.

So I think that the launch of EMPAVELI is crucial for addressing the needs of kidney patients who have historically faced challenges in treatment access, and the broad label gives us a solid foundation for growth in this area. We aim to empower nephrologists with the tools and education required for them to effectively treat C3G and IC-MPGN patients. The diligence of our commercial team is ensuring that we are making significant inroads into building awareness and access.

Our next question comes from the line of Graig Suvannavejh with Mizuho.

Congrats on the progress. Just wanted to go back to EMPAVELI. I might have missed it before, but anyway you can provide a sense of breakout in terms of the revenue and what came from PNH and what came from the new rare kidney indications and how the 152 in new patient start forms, how that might have contributed to whatever contribution there was to EMPAVELI revenue from the new rare kidney indications.

Thank you for the questions, Graig. This is Tim. You can look at our PNH revenue over the last few quarters. In the last quarter, we reported approximately $20.3 million in EMPAVELI revenue, and that market has remained relatively stable. From a revenue perspective, you might consider that we're likely putting some inventory into play as a distributor. However, we don't break down that revenue and don't intend to because it's challenging for us to do so. Could you please repeat the second part of your question? I apologize.

Yes. If we estimate around $20 million from PNH and consider some inventory build, could you clarify how much of the $152 million in patient start forms is reflected in the revenue from rare kidney indications for EMPAVELI this quarter? I'm also interested in understanding what the fourth quarter might look like, even though I know you're not providing specific sales guidance.

Yes. We're not providing sales guidance. We did give you some guidance on sort of an expectation around start forms for the year-end, which was $225 million. So look, I think the way to think about this probably is looking at the time to getting on drug from start form to getting on drug is approximately 4 to 6 weeks, and I would just work backwards from that.

Our next question comes from the line of Lisa Walter with RBC.

Congrats on the kidney launch. I was just wondering if you could provide us any color on the pivotal trial design for FSGS and DGF.

Thank you so much. So these trials have just started. We're not providing details beyond what's available on clinicaltrials.gov. But we're really excited about the opportunity that we have in FSGS and DGF. FSGS, as a reminder, affects about 13,000 patients in the U.S., similar in terms of severity to the patient and the patient's kidney to what we see with C3G and IC-MPGN. And we're looking forward to hopefully having a treatment available for these patients. With delayed graft function, we are looking into a three-month treatment with EMPAVELI to protect the kidneys that typically come from diseased donors, of which there are 21,000 per year. And about probably 30% of those patients will suffer from that so-called delayed graft function, which is an increase in creatinine in the week post-transplant.

Ladies and gentlemen, we have time for one last question, which will come from Yigal Nochomovitz with Citigroup.

I have one quick follow-up regarding the prefilled syringe. Cedric, Tim, or David, will it also be available as samples, or will it be limited to just the commercial drug for the prefilled syringe?

Thanks. This is David. So we will launch with commercial product. And then over time, we'll have samples available as we get into the launch.

I would like to turn the call back over to Cedric for closing remarks.

Thank you so much, and thank you, everybody, for your thoughtful questions. This concludes the Apellis third-quarter earnings call, and I hope you all have a wonderful rest of the day.

Ladies and gentlemen, that concludes today's conference. Thank you for your participation. You may now disconnect.