Q3 2025 Apellis Pharmaceuticals Inc Earnings Call

David Acheson: SA.

Cedric Francois: Foreign Good.

Eva Straynoski: 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 Straynoski, Head of Investor Relations. Please go ahead. Good morning and thank you for joining us to discuss 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.

Speaker #2: Good morning , ladies and gentlemen . Thank you for standing by . And welcome to the Apellis Pharmaceuticals . Third quarter 2020 Earnings Conference Call .

Speaker #2: Please be advised that today's conference is being recorded . I would now like to turn the call over to Yvonne Strahovski , head of Investor Relations .

Speaker #3: Good morning, and thank you for joining us to discuss 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, Timothy Sullivan.

Speaker #3: Before we begin , let me point out that we will be making forward looking statements that are based on our current expectations and beliefs .

Speaker #3: These statements are subject to certain risks and uncertainties and actual results may differ materially . I encourage you to Officer Tim consult the risk factors discussed in our SEC filings for additional detail .

Eva Straynoski: 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.

Speaker #3: Now , I'll turn the call over to Cedric .

Cedric Francois: 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.

Speaker #4: 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 .

Speaker #4: Apellis is a commercial-stage biotech company targeting the overactivation of the complement system and the innate defense mechanism in the immune system that protects the body from acute infection and illness.

Speaker #4: 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 .

Speaker #4: Most approved complement targeted therapeutics inhibit at C5 , a downstream protein in the complement cascade by only blocking this target . Pde5 inhibitors do not affect the upstream activity that drives inflammation and tissue damage .

Cedric Francois: Similarly, inhibitors of factor B act earlier in the cascade and narrowly reduce alternative pathway amplification but allow 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.

Speaker #4: 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 .

Speaker #4: 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 .

Speaker #4: 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 .

Speaker #4: A solved this challenge by engineering pegcetacoplan , a first in class C3 inhibitor that controls overactive complement . While preserving essential immune function .

Speaker #4: The result is both a technological feat in drug design and a transformative clinical advancement for patients . This vision is what sets Apellis apart .

Cedric Francois: 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. Syzfovre 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's 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.

Speaker #4: 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 .

Speaker #4: Apellis is a commercial stage leader with a truly differentiated C3 platform . That is the first ever treatment for geographic atrophy . Having shown robust efficacy in slowing disease progression in the broadest patient population and Pavilion has demonstrated best in class hemoglobin improvement in PNH and the ability to completely clear C3 deposits from the kidney .

Speaker #4: Together , these achievements underscore our unprecedented clinical innovation and strengthen our 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 .

Cedric Francois: A key milestone was the FDA approval of Empaveli, ready 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 Syzfovre, geographic atrophy is a devastating disease that progressively and permanently robs patients of their vision.

Speaker #4: 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 ICMP.

Speaker #4: This approval expands the addressable market for Empaveli by approximately 5000 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 .

Speaker #4: 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 .

Speaker #4: David will share more . The launch progress shortly . Moving to Syfovre . Geographic atrophy is a devastating disease that progressively and permanently robs patients of their vision .

Cedric Francois: Unfortunately, in managing GA, many retina specialists have adopted a wait and see approach despite Syzfovre'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.

Speaker #4: Unfortunately , in managing GA , many retina specialists have adopted a wait and see approach . Despite several well-established clinical profile that demonstrated robust , sustained and increasing benefits with every other month dosing .

Speaker #4: Because of this , only about 10% of patients diagnosed with GA are treated with complement inhibitors . Today , in the near term .

Speaker #4: 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 .

Speaker #4: We believe these initiatives will accelerate 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 Self-offering and advance our pipeline .

Cedric Francois: With this in mind, we continue to maximize our market opportunities for Empaveli, drive expansion for Syzfovre, and advance our pipeline. I will now hand the call over to David for an update on our commercial activities.

Speaker #4: I will now hand the call over to David for an update on our commercial activities . David . Thank you .

David Acheson: David, 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 am 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: adult patients with C3G, adult patients with IC-MPGN, pediatric patients with C3G, primary IC-MPGN patients age 12 years and older, and patients with post-transplant C3G disease recurrence. Empaveli is the only approved therapy for approximately 2/3 of this 5,000 patient population, and we believe it offers highly differentiated efficacy for the other third where patients have an alternative.

Speaker #5: , Cedric , and good morning , everyone . I'll start with Empaveli and the recent approval in C3 and primary . ICMP . We are now two months into the launch and I am very pleased with our progress so far .

Speaker #5: 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 C3 and primary IC patients.

Speaker #5: Notably , broad label makes it the first and only treatment approved for a comprehensive list of patient populations , including adult patients with C3 .

Speaker #5: Adult patients with IC and pediatric patients with C3 primary IC , and patients aged 12 years and older , and patients with post-transplant C3 disease recurrence .

Speaker #5: Empaveli is the only approved therapy for approximately two thirds of this 5000 patient population , and we believe it offers highly differentiated efficacy for the other third , where patients have an alternative .

David Acheson: Together, the broad label and the strong clinical data position the launch of Empaveli for 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 autoinjector. 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.

Speaker #5: 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 .

Speaker #5: Empaveli is delivered through our compact, single-use, on-body autoinjector. Patients can self-administer in the comfort of their own home without ever seeing a needle.

Speaker #5: 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 .

David Acheson: 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've 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 four to six weeks for a patient to start treatment. We see opportunities to potentially accelerate this.

Speaker #5: Ahead of the launch , we scaled our field based teams to approximately 100 people , ensuring coverage of every US nephrologist managing these patients .

Speaker #5: Our extensive pre-launch 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 .

Speaker #5: We've received 152 patient start forms for Empaveli . Included in this number are the approximately 50 patients from our expanded Access program , or EAP , who were in the process of converting over to commercial drug .

Speaker #5: 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 .

Speaker #5: 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 .

Tim Sullivan: Time frame as we gain more experience.

David Acheson: 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 to. Furthermore, our dedicated Apellis Assist 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.

Speaker #5: 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 world adoption across real priority accounts on the access front , we are encouraged by payers recognition of the value of n , C3 and primary ICMP , and by the speed at which these patients are successfully gaining access .

Speaker #5: Furthermore , our dedicated Appellate 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 .

David Acheson: 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 one time 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.

Speaker #5: 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.

Speaker #5: 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 .

Speaker #5: We believe we have worked through most of the one time wave of early adopters and EAP patients , and expect to receive 225 cumulative star forms or more by the end of this year .

Speaker #5: 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 .

David Acheson: 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.

Speaker #5: 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 .

Speaker #5: Today , only about 10% of patients who are diagnosed with GA are being treated and specifically for retina specialists , on average , just 1 in 5 patients with GA in their practice are treated with a complement inhibitor .

Speaker #5: 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 who see 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 .

David Acheson: 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 see 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.

Speaker #5: I will now hand the call over to Caroline to share additional color on these initiatives and provide an update on our pipeline . Caroline .

Eva Straynoski: Caroline, thanks David. Let me start with Syzfovre and geographic atrophy. As the only approved drug that binds to C3, the central protein of the complement cascade, Syzfovre 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 retina tissue. To support this, we are developing AI-driven tools that will help physicians gain a better understanding of what GA patients experience as well as the benefit of treatment with Syzfovre. We are also working to provide more convenient administration through the development of a prefilled syringe.

Speaker #3: Thanks , David .

Speaker #6: 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 .

Speaker #6: 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 retina 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 .

Speaker #6: 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.

Eva Straynoski: We believe that both of these key initiatives will broaden the prescriber universe within the overall GA market and drive higher utilization of Syzfovre over time. Turning now to Empaveli in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (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 7 abstracts at next week's American Society of Nephrology meeting, further demonstrating Empaveli's profound and durable benefits 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 (FSGS) and delayed graft function (DGF). Similar to C3G, FSGS is a rare kidney disease that progresses to kidney failure within five to 10 years for about half of patients.

Speaker #6: Turning now to AMP in C3 and primary ESI, 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.

Speaker #6: We're excited to share seven abstracts at next week's American Society of Nephrology meeting . Further demonstrating Empedocles profound and durable benefits and underscoring our commitment to the rare nephrology community .

Speaker #6: Building on this momentum , we are expanding and development into two other rare kidney diseases primary focal segmental glomerulosclerosis or fsgs , and delayed graft function or dgf .

Speaker #6: Similar to C3 , fsgs is a rare kidney disease that progresses to kidney failure within 5 to 10 years for about half of patients .

Eva Straynoski: 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.

Speaker #6: 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 .

Speaker #6: We are well underway with our planning activities and expect to initiate pivotal trials in fsgs and dgf by the end of the year .

Speaker #6: With that , I'll now turn the call over to Tim for an update of the financials .

Tim Sullivan: Thank you, Caroline. Total revenue for the third quarter was $459 million, including the $275 million upfront payment from Sobi in connection with the Empaveli royalty purchase agreement. Syzfovre net product revenue for the quarter was $151 million. We delivered approximately 101,000 doses of Syzfovre in the quarter, including 86,000 commercial doses and 15,000 free goods doses. In line with our expectations, we saw 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 Syzfovre revenue.

Speaker #3: Thank you . Caroline . Total revenue for the third quarter was $459 million , including the $275 million upfront payment from Sobi in connection with the royalty purchase agreement .

Speaker #3: 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 .

Speaker #3: In line with our expectations . We saw 4% sequential growth in overall total injection demand during the third quarter , driven predominantly by free goods .

Speaker #3: 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 .

Speaker #3: 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 total injection growth within the low to mid-single digit range.

Tim Sullivan: Looking ahead to the fourth quarter, we continue to expect modest Syzfovre total injection growth within the low to mid single digit range. Turning to gross to net dynamics, adjustments during the third quarter for Syzfovre 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 stepwise pattern of gross to nets over time, with modest degradation and some quarter to quarter movement that's typical in the buy and build 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.

Speaker #3: 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 .

Speaker #3: As we move into Q4 , we expect gross to net to trend slightly above the prior range . This reflects the normal stepwise pattern of gross to nets over time , with modest degradation and some quarter to quarter movement .

Speaker #3: 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 .

Speaker #3: From a channel perspective , we anticipate a modest channel build during the fourth quarter , consistent with seasonal patterns expected at year end .

Tim Sullivan: That said, we continue to target stable inventory levels quarter over quarter and will provide further commentary during our year end update. Taken together, our current view is that the fourth quarter Syzfovre 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 Syzfovre's growth over the next 12 to 18 months. We remain confident in the meaningful long term potential of Syzfovre 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.

Speaker #3: That said , we continue to target stable inventory levels quarter over quarter and will provide further commentary during our year end update . Taken together , our current view is that the fourth quarter revenue will be broadly in line with what we recorded in the third quarter .

Speaker #3: Looking beyond these short term dynamics , as Cedric and Caroline mentioned , we have several compelling opportunities that are largely within our control to reinvigorate growth over the next 12 to 18 months .

Speaker #3: 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 .

Speaker #3: Moving now to Empaveli . Total . Net product revenue across indications , which includes PNH , C3 and primary , ICM was $27 million during the third quarter .

Tim Sullivan: 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 Syzfovre 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.

Speaker #3: 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 .

Speaker #3: 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 .

Speaker #3: 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 2020 .

Speaker #3: For . We ended the quarter with 475 million in cash and cash equivalents , supported by the 275 million upfront from our Sobi royalty and transaction this quarter .

Speaker #3: 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 .

Tim Sullivan: 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. With that, I will now turn the call back over to Cedric. Cedric, thank you, Tim.

Speaker #3: We continue to expect our cash position will be sufficient to fund the business to sustainable profitability. And with that, I'll now turn the call back over to Cedric.

Speaker #3: Cedric .

Speaker #4: 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 C3 and primary SCMP .

Cedric Francois: 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 C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (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, Syzfovre 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.

Speaker #4: In 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 compelling efficacy , profile and its value as a new treatment option .

Speaker #4: Additionally, C4 continues its market leadership and delivers a durable, meaningful revenue stream with opportunities for renewed growth over the long term.

Speaker #4: 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 .

Cedric Francois: With that, I'll turn the call over to the operator for questions and answers.

Speaker #4: And with that , I'll turn the call over to the operator for questions and answers .

Eva Straynoski: Thank you, ladies and gentlemen. To ask the question, please press Star one one on your telephone, then wait for your name to be announced. To withdraw your question, please press Star one one. Again, we ask that you limit yourself to one question only. Once your question has been asked, you will then be removed from the stage. Please stand by while we compile the Q&A roster. Our first question comes from the line of John Miller with Evercore ISI. Your line is open.

Speaker #2: Thank you . Ladies and gentlemen , to ask the question , please press star one one on your telephone . Then wait for your name to be announced .

Speaker #2: To withdraw your question , please press star one one again . We ask that you limit yourself to one question only . Once your question has been asked , you will then be removed from the stage .

Speaker #2: Please stand by while we compile the Q&A roster . Our first question comes from the line of John Miller with Evercore ISI . Your line is open .

Cedric Francois: Hi guys.

Tim Sullivan: Thanks so much for taking my question and congrats on other progress and a strong C3G launch. I guess I'll ask my question about that. Do you still expect past this first bolus of patients that you were talking.

Speaker #7: Hi , guys . Thanks so much for taking my question and congrats on all the progress and a strong 3G launch . I guess I'll ask my question .

Speaker #7: I'll ask my question about that . Do you still expect past this first bolus of patients that you were talking about ? That kidney is going to be a distributed or slow indication instead of indications to penetrate .

Cedric Francois: About that kidney is going to be.

Tim Sullivan: Distributed or slow indications? Set of indications to penetrate? I think this has been your commentary and the competitor's commentary in the past. Do you expect that to continue, or is your strong penetration into these top practices indicative that the launch could be more rapid than people expect?

Speaker #7: I think this has been your commentary in the competitors commentary in the past . Do you expect that to continue , or is your strong penetration into these top practices indicative of the launch ?

Speaker #7: Could be more rapid than than people expect ?

Cedric Francois: Thank you, John. Great to hear you. I will hand that question over to David.

Speaker #4: Thank you . John . Great to hear you . And I will hand that question over to David .

David Acheson: Hey John, thanks for the question. Appreciate it. 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. I do suspect, as we get through the end of this year, that the bullets that we had talked about will be through that and you'll see steady, consistent growth going into next year. That's our expectation.

Speaker #5: Hey , John , thanks for the question . Appreciate it . So first of all , we're really excited about where we are with the launch for belly and 3G .

Speaker #5: And primary ICMP . Again , the team has done a great job . And I do suspect , you know , as we get through the end of this year that the bullets that we had talked about will be through that .

Speaker #5: And you'll see steady consistent growth going into next year . That's our expectation .

Eva Straynoski: Take the next question. Operator, our next question comes from the line of Anupal Rama with JP Morgan. Your line is open.

Speaker #8: Next question . Operator .

Speaker #2: Our next question comes from the line of Anupa Rama with J.P. Morgan . Your line is open .

Tim Sullivan: Hey guys, thanks so much for taking the question. Just a quick one on Syzfovre 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.

Speaker #9: Hey , guys . Thanks so much for taking the question . 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 .

Speaker #9: 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 ?

David Acheson: More stabilized, or is there a chance that this continues to creep up as you expand the market? Thanks so much.

Speaker #9: Thanks so much .

Cedric Francois: Hey Anupam, great hearing you again. I'm going to hand it over to David.

Speaker #4: And great hearing you. Again, I'm going to hand it over to David.

David Acheson: Hey Anupam, thanks for the question. A couple things real quick. We definitely review where we are with samples in the PAP program or free goods consistently to make sure the programs are being utilized the way that we.

Speaker #5: Hey , 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 the programs are being utilized .

Tim Sullivan: Want them to be.

Speaker #5: 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 .

David Acheson: Also, as you know, as a company, we are very in tune to making sure patients have access to products. As things continue to grow, we'll have programs available for patients.

Speaker #5: So as things continue to grow , we'll have programs available for for patients .

Eva Straynoski: Thank you. Our next question comes from the line of Steve Seedhouse with Cancer. Your line is open.

Speaker #2: Thank you . Our next question comes from the line of Steve Seedhouse with Cantor . Your line is open .

Cedric Francois: Good morning.

Tim Sullivan: Thanks for taking the questions.

Speaker #10: Hi . Good morning . Thanks for taking the questions . Just wanted to ask a few specifics on C3 , G . So first , can you break out just of the 150 odd patients ?

Cedric Francois: Just wanted to ask a few specifics on C3 glomerulopathy (C3G).

Tim Sullivan: Can you break out just.

Cedric Francois: Of the 150 odd patients, how many are C3G?

Speaker #10: How many are C3 , g how many are IC pre versus post transplant ? Adult versus adolescent . And then also do you know if anyone has switched from Feb to Empaveli .

Tim Sullivan: How many are IC-MPGN? Pre versus post-transplant, adult versus adolescent?

David Acheson: Do you know if.

Cedric Francois: Anyone has switched from Fabhalta to Empaveli?

Tim Sullivan: Do you have a sense of.

Speaker #10: And do you have a sense of your market share in C3 G . Just how many patients are on fed versus . Thank you .

Cedric Francois: Your market share in C3 glomerulopathy (C3G)? Just how many patients are on Fabhalta vs Empaveli?

Tim Sullivan: Than.

David Acheson: Thank you, Steve. Great questions. This is David. 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. We are seeing Fab Alta 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.

Speaker #5: Thank you Steve . Great questions . This is David . So you're right . We have 152 star forums . Roughly 50 of those came through our EAP program consistently to label .

Speaker #5: 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 and the information we've gotten from physicians as a result of our efficacy in some cases , some tolerability .

Speaker #5: And the ability for them to dose twice weekly with empaveli versus twice daily with the competitive product .

Eva Straynoski: Thank you. Please stand by for our next question. Our next question comes from the line of Yugal Nochemowitz with Citigroup. Your line is open. Check to see if you're on mute, Yugal.

Speaker #2: Thank you . Please stand by for our next question . Our next question comes from the line of Yigal Chamovitz with Citigroup . Your line is open .

Speaker #2: Check to see if you're on mute . Yigal .

David Acheson: Sorry about that.

Cedric Francois: Hi, can you hear me?

Speaker #11: Sorry about that . Hi . Can you hear me ? Yes . So this is also . Thanks for taking the question . This is also a specific question on the on the launch .

Tim Sullivan: Yes.

David Acheson: This is also.

Tim Sullivan: Thanks for taking the question. This is also a specific question on the launch. I think, David, you mentioned that 50 of the patients are in.

Speaker #11: I think , David , you mentioned that 50 of the , the patients are in the process of converting to commercial drug . These are the ones rolling over from the clinical trials .

David Acheson: The process of converting to commercial. Doug, these are the ones rolling over.

Tim Sullivan: From the clinical trials, it's just not clear. Are those actually on drug at this point? Are they still in process? The incremental other 102, can you just comment on, you know, what fraction of those have started Empaveli and approximately how long they've been on the drug since the end of July? Thank you, Yvette.

Speaker #11: It's just not clear . Are those actually on drug at this point or are they still in process . And then the incremental other 102 , could you just comment on , you know , what fraction of those have started and and approximately how long they've been on the drug since , since the end of July .

Speaker #11: Thank you .

David Acheson: Thank you for the question.

Speaker #5: You bet . Thank you for the question . So you're correct . There's 50 roughly 50 patients on each . Our goal is to make sure all of them make it to commercial product by the end of the year .

Tim Sullivan: You're correct.

David Acheson: There are roughly 50 patients on EAP. Our goal is to make sure all of them make it to commercial product by the end of the year. 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 four to six weeks for those patients to typically get from start to finish and get product. That process is also being worked up as we move through the end of the year.

Speaker #5: And of the rest that have come in for new start forms , we are still working through the process with many of them .

Speaker #5: 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 .

Tim Sullivan: Okay, thank you.

Speaker #11: Okay . Thank you .

Eva Straynoski: Thank you. Our next question comes from the line of Salvine Richter with Goldman Sachs. Your line is open. Hi, good morning. Thanks for taking our question. This is Elizabeth on for Salvine. Just one from us on that four to six 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? What do you think that could normalize as? Thank you.

Speaker #2: Thank you . Our next question comes from the line of Salveen Richter with Goldman Sachs . Your line is open .

Speaker #12: Hi . Good morning . Thanks for taking our question . 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 to treatment .

Speaker #12: When do you think we could start to see kind of an acceleration there and you know , what do you think that could normalize as thank you .

David Acheson: Thank you very much, Elizabeth. A couple things to keep in mind that's typical for most rare disease launches in particular, where you have a REMS and vaccinations and a 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 four to six weeks comes down to less than that period. We're working through that now and we'll have details as we move forward.

Speaker #5: Yeah . 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 start form that has to go in from a physician .

Speaker #5: 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 .

Speaker #5: So we're working through that now , and we'll have details as we move forward .

Eva Straynoski: Thank you. Our next question comes from the line of Akash Tawiri with Jefferies. Your line is open. Hi, this is Kathy on for Akash. If the Syzfovre rev stayed flat at $151 million quarter over quarter and.

Speaker #2: Thank you . Our next question comes from the line of Akash Tahiri with Jefferies . Your line is open .

Speaker #13: Hi , this is Kathy on for Klaus . So stayed flat at 151 million quarter over quarter in injection growth was 4% . So .

Tim Sullivan: Injection growth was 4%.

Eva Straynoski: Do you see this as the floor for Syzfovre before other components like long-term efficacy data or PSS come into play? When can we assume a return to growth for Syzfovre or do you think it stays at this level given you're not assuming patient funding gets resolved near term?

Speaker #13: One DFC this as before 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 ?

Tim Sullivan: Hi. Thank you, Kathy. This is Tim. From a growth perspective this quarter, we feel very good about the underlying demand growth of 4%. As we mentioned in the prepared remarks, the bulk of that increase in demand came from free goods. That was a headwind that we've been experiencing for the last three quarters or so. The headwind has amounted to approximately $40 million over the course of the last three quarters. Over the long term, beyond these short term dynamics, as Cedric and Caroline mentioned in their prepared remarks, we have a lot of compelling opportunities to reinvigorate Syzfovre's growth. Those include the prefilled syringe among others, and we'll get more visibility to you on those at the beginning of the year.

Speaker #3: Hi . Thank you Kathy . So this is Tim . So from a from a growth perspective this quarter we feel very good about the underlying demand growth of 4% .

Speaker #3: As we mentioned in the prepared remarks , the bulk of those of those those that increase in demand came from free goods . So that was a , you know , a headwind that we've been experiencing , you know , for the last three quarters or so .

Speaker #3: And it's , you know , the headwind has amounted to approximately 40 million over the course of the last three quarters . Now , over the long term , beyond these short term dynamics , as Cedric and Caroline mentioned in their prepared remarks , we have a lot of compelling opportunities to reinvigorate growth .

Speaker #3: Those include the prefilled syringe , among others , and we'll get more visibility to you on those . You know , at the beginning of the year .

Eva Straynoski: Thank you. Our next question comes from the line of Colleen Cussy with Baird. Your line is open. Great. Good morning. Congrats on the progress and thanks for taking our questions. 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 the launch? Thank you.

Speaker #2: Thank you . Our next question comes from the line of Colleen Casey with Baird . Your line is open .

Speaker #14: Great . Good morning . Congrats on the progress , and thanks for taking our questions . You spoke to some learnings of Prescribers Habits and 3G and Icmg at this early stage of launch .

Speaker #14: Can you elaborate on that a little bit and what the implications are for the launch ? Thank you .

David Acheson: Yeah, this is David.

Speaker #5: Yeah , this is David . Thank you . And I'll hand it over to Caroline to if there's any comments on the medical side , I can tell you that we've been very pleased with the fact that we have a very open label and we've seen patients come through that are aligned to all of the indications for both indications in the label , which is very positive .

Cedric Francois: Thank you.

David Acheson: I'll hand it over to Caroline too. If there's any comments on the medical side, I can tell you that we've been very pleased with the fact that we have a very open label, and we've seen patients come through that are aligned to all of the indications for both indications in the label, which is what we're learning now. We're making sure that we get through the process in education with the top 20 accounts and also make sure that we are continuing to canvas and have the conversations with all of the accounts beyond that. It is a new indication and a new product for folks, and they're learning how to adjust to it. We're excited about the launch.

Speaker #5: And what we're learning now is making sure that we get through the process in education with the top 20 accounts , and also make sure that we are continuing to canvas and have the conversations with all of the accounts beyond that .

Speaker #5: So it's a new indication and a new product for folks . And they're learning how to adjust to it . But we're excited about the launch so far .

Eva Straynoski: 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, amongst other abstracts that we have highlighting the reductions in proteinuria.

Speaker #6: 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 .

Speaker #6: Amongst other abstracts that we have , highlighting the reductions in proteinuria .

Speaker #4: Yeah , maybe , maybe one last thing here from from me . This is Cedric . It's been really gratifying to see how how well , we kind of were prepared and understand the landscape .

Cedric Francois: 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. It's gratifying to see the results from clinical trials translate in the real world the way it does.

Speaker #4: We're very happy with the demographics that we have calculated . The ramp , the forecasts we've created . So , you know , it's gratifying to see the results from clinical trials translate in the real world the way it does .

Eva Straynoski: Thank you. Our next question comes from the line of Ellen Hortz with TD Cowen. Your line is open. Hi guys. I'm on for Phil this morning. Congrats on the quarter. Just one question from us on Syzfovre. Has there been any progress with the Good Days copay assistance charity? Is there any visibility on when and if it can be funded to assist GA patients? Thanks.

Speaker #2: Thank you . Our next question comes from the line of Ellen Hawks with TD Cohen . Your line is open .

Speaker #15: Hi guys . 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 copay assistance charity ?

Speaker #15: Is there any visibility on when and if it can be funded to assist GA patients ? Thanks .

Tim Sullivan: Hi, thank you for the question. This is Tim. There has been some progress in the sense that we understand that the largest of these groups is open for existing patients, but unfortunately not for new patients. You can check that on the website. As far as we know and as far as our guidance that we gave in terms of this quarter, we don't expect anything to change with respect to the patient assistance organizations.

Speaker #3: Hi . Thank you for the question . This is Tim . So there has been some progress in the sense that we understand that the the largest of these groups is is open for existing patients , but unfortunately not for for new patients .

Speaker #3: And you can check that on the on the website . But as far as we know and as far as we're , you know , as far as our , you know , guidance that we gave in terms of this quarter , we don't we don't expect anything to change with respect to the patient assistance organizations .

Eva Straynoski: Thank you. Our next question comes from the line of Jade Moman with Stifel. Your line is open.

Speaker #2: Thank you . Our next question comes from the line of Jade Momin with Stifel . Your line is open .

David Acheson: Hi, this is Jayette on for Annabelle.

Speaker #16: Hi , this is Diane on for Annabel . Two questions . The first one is for SeatGeek . For that , one third shared market with telehealth .

Tim Sullivan: Two questions. The first one is for C3G. For that one third shared market with that, how do you expect prescriber, how do you expect that market to bifurcate? What type of patients would are physicians starting Syzfovre in and what type of patients would be preferred for Empaveli.

Speaker #16: How do you expect prescriber ? How do you expect that market to bifurcate ? What type of patients would are physicians starting in and what type of patients would be preferred for infertility ?

Cedric Francois: Thank you for that question. This is Cedric. I think that the efficacy profile that was established in the Valiant trial across all of the patient populations that we have tested and that we've spoken about, that is really what stands out there. This is something that we believe is going to be really important in a segment of physicians that cares deeply about differentiated efficacy. I think we have, with the broad label that we have, an opportunity to really kind of go through segment by segment. We've talked before about the fact that post-transplant patients are a particularly interesting group for obvious reasons. Most transplanted patients will relapse. It takes a little bit of time to get on protocols, et cetera, but that's a very exciting group of patients that we're looking forward to being able to help.

Speaker #4: Yeah . Thank you for that question . This is Cedric . So I think that look the the the efficacy profile that was established in the valiant trial across all of the patient populations that we , you know , have have tested and that we've spoken about , that is really what stands out So this is something that we believe is going to be really important in , you know , a segment of physicians that cares deeply about differentiated efficacy .

Speaker #4: So , yeah , I think we have with the broad label that we have , we have an opportunity to really kind of go through segment by segment .

Speaker #4: We've talked before about the fact that post-transplant patients are a particularly interesting group , for obvious there . reasons . Most transplanted patients will relapse now takes a little bit of time to get on protocols , etc.

Speaker #4: , but that's a very exciting group of patients that we're looking forward to being able to help . And then , of course , patients that are advanced at risk of going into end stage renal disease .

Cedric Francois: Of course, patients that are advanced at risk of going into end stage renal disease. The fact that we have pediatrics in our label as well and be able to offer something to patients 12 years to 18 years is very attractive to the nephrology community as well.

Speaker #4: And then the fact that we have pediatrics in our label as well , and be able to offer something to patients 12 years to 18 years is is very attractive to the nephrology community as well .

Tim Sullivan: One more on Syzfovre. It's been on the market for.

Speaker #16: Thank you . And I've got one more on swipe over . It's been on the market for a couple of years now , and if you go by the pattern and whether it be , we might start to see patients drop off at this stage , what are you seeing as far as persistence on treatment ?

David Acheson: A couple of years now, and if you go by the pattern, then wet.

Tim Sullivan: We might start to see patients drop off at this stage. What are you seeing as far as.

David Acheson: Persistence on treatment.

Cedric Francois: Complaints?

Eva Straynoski: Thank you for the question. 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.

Speaker #4: Compliance ?

Speaker #17: O thank you for the question . Well , with our .

Speaker #6: 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 .

Speaker #6: And there will be some long term data coming out from our open label extension next year .

Tim Sullivan: Great. Thank you guys.

Speaker #16: Great . Thank you guys .

Eva Straynoski: Thank you. Our next question comes from the line of Lachlan Hanbury-Brown with Wimal. Your line is open.

Speaker #2: Thank you . next question comes from the line of Lache and Hanbury Brown with William Blair . Your line is open .

Speaker #2: Our

Cedric Francois: Hey, thanks for the question.

Speaker #18: Hey , guys . Thanks for the question . I guess one on Syfovre I noticed the new patient share ticked down a few points this quarter .

David Acheson: One on Syzfovre.

Tim Sullivan: I noticed the new patient share ticked.

Cedric Francois: Down a few points this quarter.

Tim Sullivan: I was wondering if there's any underlying.

Speaker #18: I was wondering if there's any underlying dynamic that changed in the quarter that drove that , or is that just sort of , you know , noise fluctuating ?

Cedric Francois: dynamic that changed in the quarter that drove that, or is that just sort of noise fluctuating a few?

Tim Sullivan: Percentage points, and it's kind of reached.

Speaker #18: A few percentage points and it's kind of

Cedric Francois: A point of stability here.

Speaker #18: reached a point of stability here .

David Acheson: Yeah, great, thanks for the question. This is David. First of all, we're very confident in where we are competitively. Just a reminder, we're 52% on MBRXs and over 60%. We continue to hold and have held for TRXs. You're exactly right. What sometimes you'll see is a fluctuation in MBRXs up or down, but we're confident in the consistent numbers that we've seen in reporting today.

Speaker #5: Yeah . Great . Thanks for the question . This is David . So first of all , we're we're very confident in where we are competitively .

Speaker #5: And just a reminder that we're 52% on NBR and over 60% would continue to hold and have held for Trx's . You know you're you're exactly right .

Speaker #5: What sometimes you'll see is a fluctuation in NBR up or down . And but we're confident in , in the consistent numbers that we've seen in reporting today .

Eva Straynoski: Thank you. Our next question comes from the line of Derek Ochila with Wells Fargo. Your line is open.

Speaker #2: Thank you . Our next question comes from the line of Derek Accola with Wells Fargo . Your line is open .

Tim Sullivan: Hey, good morning and thanks for taking the questions. Maybe just two from us. First on Syzfovre, I guess how do you think about prefilled syringe? The check that we've done on that, it seems like docs would be pretty enthusiastic. 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? I didn't know if I joined late, so just in terms of infill daily start forms, any comments on trends post the quarter. Thanks.

Speaker #3: Hey good morning and thanks for taking the questions . Maybe just two from us . First on Syfovre . I guess . How do you think about prefilled syringe ?

Speaker #3: The checks that we've done on that , you know , it seems like docs would be pretty enthusiastic .

Speaker #9: So .

Speaker #3: 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 .

Speaker #3: And then I didn't know if I joined late . So just in terms of infidelity , you know , start forms . Any comments on trends post the quarter ?

Speaker #3: Thanks .

Cedric Francois: Hi Derek, great hearing you. Thank you so much. Yeah, the prefilled syringe is something that is really important in the context of the retina physicians. It improves the flow in their practices, makes it easier to handle the workload. We have been working on a prefilled syringe. That prefilled syringe is currently being tested in the clinic. We're not guiding on timelines to when it will actually be available for competitive reasons, but the quality of the syringe that we have has met the high expectations that we've had and super excited about going to market with that. I think it's also worth mentioning here.

Speaker #4: Hi Derek . Great hearing you . Thank you so much . Yeah . The prefilled syringe is something that is really important in the context of the retina .

Speaker #4: Positions . It improves the flow in their practices , makes it easier to to handle the workload . We have been working on a prefilled syringe that prefilled syringe is currently being tested in the clinic .

Speaker #4: We not guiding on timelines to when it will actually be available for competitive reasons . But the quality of the syringe that we have has met the high expectations that we've had .

Speaker #4: And super excited about going to market . With that . I think it's also worth mentioning here that the , you know , within kind of the the type of physicians that treat patients with geographic atrophy , there are a lot of physicians that occasionally use syfovre not on a regular basis .

Tim Sullivan: That.

Cedric Francois: Within kind of the type of physicians that treat patients with geographic atrophy, there are a lot of physicians that occasionally use Syzfovre, not on a regular basis. Those are physicians that I suspect are going to be excited about kind of moving towards a more routine involvement of GA patients into their practices. Even for those physicians that have not yet embraced Syzfovre as a treatment for their patients, we know that many of them are waiting for the prefilled syringe to start treating this terrible disease. I don't know, Caroline, if you want to add something.

Speaker #4: Those are physicians that I suspect are going to be excited about kind of moving towards a more routine involvement of GA patients into their practices .

Speaker #4: But even for those physicians that have not yet embraced Syfovre as a treatment for their patients , we know that many of them are waiting for the prefilled syringe to , you know , to to start treating this this terrible disease .

Speaker #4: I don't know , Caroline , if you want to add something .

Eva Straynoski: 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. I'm really, really pleased with where we're headed with this. There was another part to the question.

Speaker #6: Well , as a 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 .

Speaker #6: And I'm really , really pleased with where we're headed with this . There was another part to the question .

Speaker #8: Fourth quarter . Yes .

Tim Sullivan: Thank you again. From a launch perspective, obviously we feel great beyond the guidance that we gave in terms of the start forms for the prepared remarks. I don't think we're not guiding any further than that, but we're happy to look forward to giving you an update at the year end call.

Speaker #3: So Derek yeah , we're just the last part of that question . Thank you again . So from a from a launch perspective , obviously we feel great .

Speaker #3: You know beyond the guidance that we gave in terms of the start forms for the prepared remarks , I don't think we're we're not guiding any further than that .

Speaker #3: But we're happy to , you know , look forward to giving you an update at the year end . Call .

Eva Straynoski: Thank you. Our next question comes from the line of Byron Amin with Piper Sandler. Your line is open.

Speaker #2: Thank you . Our next question comes from the line of Byron Amin with Piper Sandler . Your line is open .

Tim Sullivan: Yeah. Hi guys, thanks for taking my questions. This morning as well, just revised Syzfovre sales guidance downward by $200 million. They're clearly seeing headwinds in GA market growth. Given that data point and your low to mid single injection growth.

Speaker #19: Yeah . Hi , guys . Thanks for taking my questions . You know , this morning as just revised Azure sales guidance downward by $200 million .

Speaker #19: And so they're clearly seeing headwinds in GA market growth . Given that data point . And you're low to mid single injection growth that you project .

Cedric Francois: Do you feel it's that you project?

Tim Sullivan: Due to undertreatment and what shifts that dynamic with retina physicians? I'll start. 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. It's had a huge impact on the market in general. 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. Not sure. I hope that answers your question.

Speaker #19: Do you feel it's due to undertreatment . And what shifts that dynamic with retina physicians .

Speaker #3: Yeah I mean so so I'll start . So I'll just confirm what you're saying , which is that we do see a significant headwind .

Speaker #3: And you know , 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 on the market in general .

Speaker #3: And you know , our at least our discussions with retinal specialists suggest that many of them are not treating GA patients or not even having the conversation .

Speaker #3: They should be having with GA patients , because this has created , you know , a logistical as well as a financial headwind .

Speaker #3: I'm not sure . I hope that answers your question .

Eva Straynoski: I think what can shift the dynamics with physicians also are multiple things that we're working on at Apellis where the science company, we have robust data. We're working on educating physicians using AI-driven tools, 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.

Speaker #6: I think what can shift the dynamics with physicians also are multiple things that we're working on at a palace where the science company we have robust data , we're working on educating physicians using artificial intelligence , which they can also use for patients .

Speaker #6: We're working on a prefilled syringe , and we have multiple new things coming forward to impact physicians and patients .

Tim Sullivan: Great, thank you.

Speaker #19: Great . Thank you .

Eva Straynoski: Thank you. Our next question comes from the line of Judah Frommer with Morgan Stanley. Your line is open.

Speaker #2: Thank you . Our next question comes from the line of Judah Frommer with Morgan Stanley . Your line is open .

Tim Sullivan: Yes, thanks for taking the questions. Maybe just a couple 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?

Speaker #20: Yeah . Hi , guys . Thanks for taking the questions . Maybe just a couple follow ups , I guess on on patient start forums for for CPG and ICM .

Speaker #20: Can you comment on just how they came in versus internal expectations ? 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 ?

Cedric Francois: Sounds like they came in reasonably well.

Tim Sullivan: On just the sampling for Syzfovre, any commentary you can make on how much of that is self driven versus competitive dynamics on sampling? Thank you.

Speaker #20: Thank you .

Cedric Francois: Thank you so much for the expectations with C3G and IC-MPGN. As I outlined earlier, this is very much in line with what we had expected and we have high expectations. We also feel very good about the demographics that we have established. That number of 5,000 we believe is a robust, conservative estimate for the number of patients that are out there and could be helped with our product. Your question on Syzfovre, I'm sorry but you were breaking up.

Speaker #4: Yeah, thank you so much for the expectations with C3 and region. As I outlined earlier, this is very much in line with what we had expected.

Speaker #4: And we have expectations . We have . We also feel very good about the demographics that we have established . That number of 5000 , we believe is a robust conservative estimate for the number of patients that are out there .

Speaker #4: And could be helped with our . Then your question on cipher , I'm sorry , but you're breaking up .

David Acheson: I can answer it. It's on the samples and free goods. Your question was is there a competitive dynamic? I don't think that's necessarily the case. What we do know is if someone's 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. 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.

Speaker #5: I can answer it . It's on the samples in free goods . So your question was , is there a competitive dynamic ? I don't think that's necessarily the case .

Speaker #5: What we do know is if someone's reaching for a free good , that's true demand . It's a patient that wants to be treated .

Speaker #5: It's a physician wants to treat the patient . And we have those programs in place and monitor them regularly to make sure that they're , you know , within the guidelines that we want to have followed .

Speaker #5: But there accessible because patients that want to go on treatment , we believe should be able to do that .

Tim Sullivan: Thanks.

Speaker #21: Thanks .

Eva Straynoski: Thank you. Our next question comes from Ryan Deschner with Raymond James. Your line is open.

Speaker #2: Thank you . Our next question comes from the line of Ryan Leshner with Raymond James . Your line is open .

Speaker #22: It's open .

David Acheson: Thank you very much.

Speaker #23: Thank you very much . Can you remind us when the actual date was first made available to patients for the C3 , g ICMP ?

Tim Sullivan: Can you remind us when the actual.

David Acheson: Date Empaveli was first made available to.

Tim Sullivan: Patients for the C3 glomerulopathy (C3G), IC-MPGN launch. Do you have an update on the rough timeline for a top line readout from the phase two?

Speaker #23: Launch . And then also do you have an update on the rough timeline for a top line readout from the phase two study for Syfovre and APL 3007 ?

David Acheson: Study for Syzfovre and APL3007?

Tim Sullivan: Thanks.

Speaker #23: Thanks .

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

Speaker #5: This is David . I'll answer the first part of the question . We launched the product in the week of July 28th , and I'll hand the other portion of the question over on 307 to Cedric .

Cedric Francois: Thank you for that question. The trial is enrolling. We're very excited about this trial. As a reminder, with 3007, what we do is combine Syzfovre with a subcutaneous injection that is an siRNA product, which brings down the systemic levels of C3 by approximately 90%. The objective there is to go from every two months to every three months 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. Thank you.

Speaker #4: Yeah . 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 .

Speaker #4: 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 months dosing .

Speaker #4: And so then obviously , of course , seen outsized effect on the efficacy side . We're not guiding in terms of when that study will be completed .

Speaker #4: It's currently enrolling and has a one year endpoint readout .

Speaker #23: Thank you .

Eva Straynoski: Thank you. Our next question comes from the line of Douglas Taw with H.C. Wainwright. Your line is open.

Speaker #2: Thank you . Our next question comes from the line of Douglas Tal with H.C. Wainwright . Your line is open .

David Acheson: Hi, good morning.

Tim Sullivan: Thanks for taking the questions. Tim, I think it was you that mentioned that there's an issue with some practices with the lack of copay support, a backlog or operational challenges with practices because they're not able to easily put patients into treatment. Is that in terms of just the headache within the practice, in terms of just the time it takes to adjudicate benefits and follow that patient, or is it just this patient having an unrealistic expectation of starting treatment and then having themselves put off and having to deal with the frustration on that side.

Speaker #24: Hi . Good morning . Thanks for taking the questions , Tim . I think as you sort of mentioned , that , there was an issue with some practices , sort of just with the lack of , of , of , you know , copay support , sort of a backlog or sort of operational challenges with practices if , you know , because they're not able to easily put patients on treatment , is that in terms of just the headache within the practice , in terms of , you know , just the time it takes to sort of adjudicate benefits and follow that patient ?

Speaker #24: Or is it just the sort of patient having an unrealistic expectation of start treatment and then having themselves sort of sort of put off and sort of having to deal with the frustration on that side ?

Cedric Francois: Yeah, it's just, it's really a very complicated situation for the physicians as well as for the patients. Right. You know, kind of figuring out who can afford copay, who cannot. I mean, there's a lot that goes into it. There's a lot of chair time that is lost by the physician in that process. As Tim outlined earlier, what we've seen this year is, of course, you know, kind of a lot of slowdown that was driven by these dynamics. Not just on the GA side, also on the wet AMD side where a lot of practices, you know, have temporarily paused, even bringing on new patients to avoid having those discussions. These are all things that are headwinds that, you know, we'll have to find a new place of settlement.

Speaker #4: Yeah , it it's just it's a very it's really a very complicated situation for the physicians as well as for the patients . Right .

Speaker #4: You know , kind of figuring out who can afford copay , who cannot . I mean , there's there's a lot that goes into it .

Speaker #4: There's a lot of chair time that is lost by the physician in that process . And as Tim outlined earlier , what we've seen this year is , of course , you know , kind of a lot of that was driven by these dynamics , not just on the gay side .

Speaker #4: Also on the wet AMD side , where a lot of practices , you know , have have temporarily paused , even bringing on new patients to avoid having those discussions .

Speaker #4: So these are all things that are headwinds that , you know , will have to find a new place of settlement , you know , but but we are working hard on it .

David Acheson: You.

Cedric Francois: We are working hard on it. We can help practices with availability and access, of course, but the foundation is something that we are separated from. Of course.

Speaker #4: We can help practices , you know , with with availability and access . Of course . But the foundation is something that we , you know , that is something that we're separated from .

Tim Sullivan: 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. If I can, on the kidney launch, I'm just curious. I know obviously something that people have been wondering about in terms of the identification of patients with C3G and IC-MPGN, since it does require biopsy. Have you seen evidence that now there is an available treatment like Empaveli or such an efficacious treatment that clinicians are biopsying more regularly or more aggressively than they were in the past? Thank you.

Speaker #4: Of course .

Speaker #3: I'll also add that it particularly affects gay patients because there is a generic alternative in the wet AMD space . There is no generic alternative in the gay space

Speaker #24: I can on the on the kidney launch , I'm just curious . I know , you know , obviously something that you sort of people have been wondering about in terms of the identification of patients with C3 .

Speaker #24: G and I , since it does require a biopsy . Have you seen evidence that now there is an available treatment like or such an efficacious treatment that that clinicians are biopsying more regularly or more aggressively than they were in the past ?

Speaker #24: Thank you .

Eva Straynoski: That typically happens when there's a new treatment available for something when there was no previous treatment. There are patients that come out of the woodwork, and clinicians are also more motivated to make the diagnosis so they can more effectively treat this disease, which does ultimately end in end stage renal failure. Thank you.

Speaker #6: Well , that typically happens when there's a new treatment available for something . When there was no previous treatment that there are patients that come out of the woodwork and clinicians are also more motivated to make the diagnosis so they can more effectively treat this disease , which does ultimately end in stage renal failure .

Speaker #6: Thank you .

Tim Sullivan: Thank you.

Speaker #24: Thank you .

Eva Straynoski: Our next question comes from the line of Greg Sinonovich with Mizuho. Your line is open.

Speaker #2: Our next question comes from the line of Greg with Mizuho . Your line is open .

Tim Sullivan: Good morning. Thank you for taking my question and congrats on the progress. Just wanted to go back to Empaveli. I might have missed it before, but any way you can provide a sense of the breakout in terms of the revenue and what came from PNH and what came from the new rare kidney indications and how the 152 and new patient start forms, how that might have contributed to whatever contribution there was to Empaveli revenue from the new rare kidney indications. Thanks. Hey, Greg, thank you for the question.

Speaker #3: Hey . Good morning . Thank you for . taking my question and congrats on the progress . Just wanted to go back to Empaveli .

Speaker #3: I might have missed .

Speaker #25: It before , but any way you can provide a sense of the breakout in terms of the revenue and what came from PNH and what came from the new rare kidney indications and how the 152 and new patients start forms , how that might have contributed to wherever contribution there was to empaveli revenue from from the new rare kidney indications .

Speaker #25: Thanks .

Speaker #3: Hey , Greg , thank you for the question . This is Tim . Yeah . So so you can look at our PNH revenue for the last few quarters .

Cedric Francois: This is Tim.

Tim Sullivan: Yes, you can look at our PNH revenue for the last few quarters. Last quarter we reported, I think, $20.3 million in Empaveli revenue. That market has been relatively static. I think from the perspective of revenue, you can maybe back out a little bit there and look at the fact that we probably are also putting a little bit into inventory at the distributor. On a combined basis, we do not break out that in terms of revenue and we do not plan to break that out because it is hard for us to do that. Can you repeat the second part of the question? Apologize. Yeah, just for, if we do, and thanks for that clarity on maybe assuming $20 million or so from PNH and then maybe some inventory build, but whatever the balance is for Empaveli revenue in the quarter from the new rare kidney indications.

Speaker #3: Last quarter we reported , I think 23.20 point 3 million in , in empaveli revenue . And that market has been , you know , relatively static .

Speaker #3: So I think , you know , from from the perspective of revenue , you can maybe back out a little bit there and , you know , look at look at the fact that we probably are also putting a little bit into the , into inventory at the distributor .

Speaker #3: So , you know , on a combined basis , it's we don't break out that in terms of revenue and we don't plan to break that out because it is hard for us to do that .

Speaker #3: And then from you know , I can you repeat the second part of the question , apologize .

Speaker #25: Yeah . Just , you know , for , you know , if we do and thanks for that clarity on on maybe assuming , you know , 20 million ish or so from PNH and then maybe some inventory build .

Speaker #25: But whatever the balance is for Empaveli revenue in the quarter from the new rare kidney indications , just trying to get a sense of if you if you did provide us with 152 in terms of the patient start forms , how much of that is kind of translating into that , that balance of of revenue specifically in rare kidney and just trying to get a sense of what fourth quarter might look like , understanding that you're not providing sales guidance per se .

Tim Sullivan: Just trying to get a sense of if you did provide us with 152 in terms of the patient start forms, how much of that is translating into that balance of revenue, specifically in rare kidney, and just trying to get a sense of what fourth quarter might look like. Understanding that you are not providing sales guidance per se. We are 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. 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 four to six weeks. I would just work backwards from that. Okay, thanks so much. Thank you, Greg.

Speaker #3: Yeah , 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 were which was 225 .

Speaker #3: So , you know , look , I think the way to think about this probably is , you know , looking at the , you know , the time to getting on drug from start form to , to getting on drug is approximately 4 to 6 weeks .

Speaker #3: I would just work backwards from that .

Eva Straynoski: Thank you. Our next question comes from the line of Lisa Walter with RBC. Your line is open. Oh great. Thanks so much for taking our questions and 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. Thanks so much.

Cedric Francois: Thank you so much. 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. 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 these kidneys that typically come from deceased donors.

Tim Sullivan: Of.

Cedric Francois: 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.

Eva Straynoski: Thank you.

Cedric Francois: Thank you.

Eva Straynoski: Ladies and gentlemen, we have time for our one last question, and that will come from the line of—it's a follow-up question from the line of Yigayle Notremovitz with Citigroup. The line is open.

Tim Sullivan: Thank you. Just one quick follow up, please, on the prefilled syringe. Cedric or Tim or David, I'm just wondering, is that going to be offered also as samples?

Cedric Francois: Will it be.

Tim Sullivan: Restricted to just commercial drug for the prefilled syringe?

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

Tim Sullivan: Okay, thank you.

Eva Straynoski: Thank you. I would like to turn the call back over to Cedric for closing remarks.

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

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

Tim Sullivan: Sam.