Q1 2024 Apellis Pharmaceuticals Inc Earnings Call
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Operator: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals first quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is ready. To withdraw your question, please press star 11 again. Please be advised that today's call is being recorded. I will now turn the call over to your speaker host, Meredith Kaya, Senior Vice President, Investor Relations and Strategic Finance. Please go ahead.
Speaker Change: Good morning, ladies and gentlemen, thank you for standing by and welcome to the Palace Pharmaceuticals first quarter 2024 earnings Conference call.
Speaker Change: At this time all participants are in a listen only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session.
Speaker Change: To ask a question during the session you will need to press star one on your telephone.
Speaker Change: Then here an automated message advising your hand is race to withdraw your question. Please press star one again.
Speaker Change: Please be advised today's call is being recorded.
Speaker Change: I'll now turn the call over to your Speaker host Meredith Carla Senior Vice President Investor Relations and strategic Finance. Please go ahead.
Meredith Kaya: Good morning, and thank you for joining us to discuss Apellis's first quarter 2024 financial results. With me on the call are Co-Founder and Chief Executive Officer, Dr. Cedric Francois, Chief Operating Officer, Adam Townsend, Chief Medical Officer, Dr. Caroline Baumal, and Chief Financial Officer, Tim Sullivan.
Meredith Kaya: Good morning, and thank you for joining us to discuss our pellets with first quarter 2024 financial results.
Meredith Kaya: With me on the call are co founder and Chief Executive Officer, Dr. Cedric Francois.
Meredith Kaya: Chief operating officer, Adam Townsend, Chief Medical officers, Dr. Caroline Palmer, Chief Financial Officer, Tim Sullivan.
Meredith Kaya: Before we begin, let me point out that we will be making four forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now, I'll turn the call over to Cedric.
Meredith Kaya: Before we begin let me point out that we'll be making forward looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and actual results may differ materially I.
Meredith Kaya: 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.
Cedric Francois: Thank you, Meredith, and thank you all for joining us this morning. 2024 is off to a strong start. Saifovri continues to deliver robust growth in the first quarter, driven by an acceleration in demand, resulting in $137 million in net sales, up 20% compared to Q4. EmpaVedi is also making a difference for patients with BNH, generating $26 million in revenue for the quarter, and we have a number of exciting opportunities to potentially expand EmpaVedi into new indications.
Cedric Francois: Thank you Meredith and thank you all for joining us this morning.
Cedric Francois: 2024 is off to a strong start say for re continues to deliver robust growth in the first quarter driven by an acceleration in demand, resulting in $137 million in net sales.
Cedric Francois: 20% compared to Q4.
Cedric Francois: And part of it is also making a difference for patients with B N H generating $26 million in revenue for the quarter and we have a number of exciting opportunities to potentially expand in poverty into new indications.
Cedric Francois: We are one of the rare companies in our industry to have two drugs approved in just three years, a testament to the strength of our science and our incredible team. As a result, Apellis is now well positioned strategically, operationally, and financially to deliver significant long-term value to our shareholders. Syphovery is key to delivering this long-term value, and the growth in Q1 underscores the strong demand we continue to see from both physicians and patients. Through March, eye care professionals administer 250,000 syphilis injections.
Cedric Francois: We are one of the rare companies in our industry to have two drugs approved in just three years, a testament to the strength of our science and our incredible team.
Cedric Francois: As a result.
Cedric Francois: <unk> is now well positioned strategically.
Cedric Francois: Operationally and financially to deliver significant long term value to our shareholders.
Cedric Francois: <unk> is key to delivering this long term value and the growth in Q1 underscores the strong demand we continue to see from both physicians and patients.
Cedric Francois: Through March Eyecare professionals administers 250000, and safe ovary injections and in the first 12 months of launch sexual regenerate its over $400 million and sales substantially exceeding both our and wall Street's expectations.
Cedric Francois: And in the first 12 months of launch, Sifo generated over $400 million in sales, substantially exceeding both our and Wall Street's expectations. This is extraordinary performance for any new product launch. Saifovri's leadership in the market is driven by three important factors.
Cedric Francois: This is extraordinary performance for any new product launch.
Cedric Francois: Treatment with syphilis results in increasing effects over time, with up to 42% slowing of GA progression in year three of GAIL, building on the meaningful effect demonstrated in Derby and Oakes. Second, CIFURI has a well-documented safety profile based on extensive experience, both clinically and in the real world. And third, SAIF-OVRI offers flexible dosing, as described in our label, which means that patients can benefit from SAIF-OVRI's impressive clinical profile with as few as six doses per year. As the market leader, we are only getting started.
Cedric Francois: <unk> leadership in the market is driven by three important sectors.
Cedric Francois: Treatment with full results in increasingly effects overtime with up to 42% slowing of GAA progression and your three of Gail building on the meaningful effect demonstrated in Derby and Oaks.
Cedric Francois: Second <unk> has a well documented safety profile based on extensive experience both clinically and in the real world.
Cedric Francois: And third <unk> offers flexible dosing as described in our label, which means that patients can benefit from <unk> impressive clinical profile and as few as six doses per year.
Cedric Francois: As the market leader, we are only getting started our performance to date reaffirms our belief that <unk> has the potential to become a multibillion dollar product in the U S alone.
Cedric Francois: Our performance to date reaffirms our belief that Sifo-Re has the potential to become a multi-billion dollar product in the U.S. alone. We are also working to bring safe ovary to patients worldwide. We recently announced that the European Medicines Agency reset the review of the CIFOR reapplication back to day 180 of our initial assessment, which is the last phase of that procedure. This decision follows a judgment made by the Court of Justice in the EU regarding the competing interests of experts. The decision on CIFORI is strictly procedural and not related to the CIFORI application.
Cedric Francois: We are also working to bring <unk> to patients worldwide.
Cedric Francois: We recently announced that the European Medicines agency reset the review of the safe for re application back to day 180 of our initial assessment.
Cedric Francois: Which is the last phase of that procedure.
Cedric Francois: This decision follows a judgment made by the court of Justice and the EU regarding the competing interests of experts.
Cedric Francois: The decision for us therefore, strictly procedural and not related to just say full re application.
Cedric Francois: The remainder of our review is expected to be led by the original rapporteurs. We are working closely with the CHMP and EMEA on next steps, with the upcoming CHMP opinion anticipated no later than July. Shifting to EmpaVedi, since its launch in 2021, EmpaVedi has transformed the standard of care for patients with PNH. It was the first available treatment proven to effectively control both intravascular and extravascular hemolysis, two hallmarks of PNH, while also significantly improving anemia and protecting the majority of patients from transfusions over the long term.
Cedric Francois: The remainder of our review is expected to be led by the original Rapporteurs.
Cedric Francois: We're working closely with the <unk> and EMEA on next steps with the upcoming <unk> opinion anticipated no later than July.
Cedric Francois: Shifting to <unk> since its launch in 2021 empathy has transformed the standard of care for patients with <unk>.
Cedric Francois: Video is the first available treatments proven to effectively control, both intra vascular and extra vascular hemolysis, two hallmarks of pn niche, while also significantly improving anemia and protecting the majority of patients from transfusions over the long term.
Cedric Francois: We continue to serve PNH patients who may benefit from Empavedi, and we believe it has the potential to become a best-in-class treatment option for additional high unmet need areas. Our biggest near-term opportunity is in C3G and ICMPGN, two rare and devastating kidney diseases that often start in adolescence. There are currently no approved treatments for these diseases, which often lead to kidney failure or lifelong dialysis.
Cedric Francois: We continue to serve <unk> patients, who may benefit from <unk> and we believe it has the potential to become a best in class treatment option for additional high unmet need areas.
Cedric Francois: Our biggest near term opportunity is in <unk>, and <unk> PGM to rare and devastating kidney diseases that often start in adolescence.
Cedric Francois: There are currently no approved treatments for these diseases, which often leads to kidney failure or lifelong dialysis.
Cedric Francois: Our Phase 2 NOBLE data showed unprecedented effects on disease activity, including complete clearing of disease activity in 40% of the treated patients at week 12, and reductions by one or more magnitudes of intensity in 80% of treated patients. We plan to share the 52-week data from the NOBLE study at the European Renal Association meeting later this month. And we look forward to sharing the top-line data from our Phase III Valiant Study in mid-2024.
Cedric Francois: Our phase II <unk> data shows unprecedented effects on disease activity.
Cedric Francois: Including complete clearing of disease activity and 40% of the treated patients at week 12, and reductions by one or more of magnitudes of intensity in 80% of treated patients.
Cedric Francois: We plan to share the 52 week data from de Novo study at the European Renal Association meeting later this month and.
Cedric Francois: And we look forward to sharing the top line data from our phase III Valeant study in mid 2024.
Cedric Francois: Separately, I'm sure many of you saw the recent news out of New York University regarding the first ever combined mechanical heart pump and big kidney transplant. This was a historic event, and we are thrilled that Empavedi played a role in making this xenotransplant surgery a success by helping to protect the kidney from potential rejection. M. Pavetti was also involved in the xenotransplant surgery performed at Mass General Hospital in March by helping to stabilize the transplanted kidney when it showed signs of early rejection.
Cedric Francois: Separately I am sure. Many of you saw the recent news out of New York University regarding the first ever combined mechanical heartburn and <unk> kidney transplant.
Cedric Francois: This was a historic event and we are thrilled that empathy that you played a role in making this casino transplant surgery, a success by helping to protect ticket me from potential rejection.
Cedric Francois: <unk> was also involved in the casino transplant surgery performed at mass General Hospital in March by helping to stabilize the transplanted kidney when it showed signs of early rejection.
Cedric Francois: And while the research is early, and we have a lot to learn still, we are encouraged by the potential of empaveli in xenotransplantation. Overall, I am thrilled with the progress we have made so far in 2024. With two commercial products and an emerging pipeline, which we are excited to share more about later this year, we remain steadfast in our vision to develop life-changing medicines for people living with some of the most challenging diseases. And with that, I will now turn it over to Adam to discuss our commercial activities.
Cedric Francois: And while the researches early and we have a lot to learn still we are encouraged by the potential of <unk> and casino transplantation.
Cedric Francois: Overall I am thrilled with the progress we have made so far in 2024.
Cedric Francois: With two commercial products and an emerging pipeline, which we are excited to share more about later this year. We remained steadfast in our vision to develop a life changing medicines for people living with some of the most challenging diseases.
Cedric Francois: And with that I will now turn it over to Adam to discuss our commercial activities.
Adam J. Townsend: Thanks, Cedric, and good morning, everyone. I will jump right in with Siphovery. As Cedric shared, Siphovery's sales over the past 12 months have been strong. Initially, our success was largely driven by fast uptake from early adopters. More wheat.
Adam J. Townsend: Thanks, Patrick and good morning, everyone.
Adam J. Townsend: I will jump right in with FIFO great.
Adam J. Townsend: Cedric <unk> <unk>.
Adam J. Townsend: The past 12 months have been strong.
Adam J. Townsend: Initially our success.
Speaker Change: With largely driven by fast uptake from early adopters more recently, we've seen both new patient demand and an increasing prescriber base driving sales.
Adam J. Townsend: We've seen both new patient demand and an increasing prescriber base driving sales. While we continue to focus our marketing efforts on retina specialists, we are also educating the referring eye care provider network on the importance of patients with GA getting the treatment they need. In addition, we are investing in direct-to-consumer marketing initiatives to increase patient awareness and education about cyfovir and GMS. Suffice to say, our efforts are paying off. In the first quarter, we distributed 72,000 commercial doses and 5,000 samples.
Adam J. Townsend: While we continue to focus our marketing efforts on retina specialists.
Adam J. Townsend: Are also educating the referring I can provide a network on the importance of patients with <unk> getting the treatment they need.
Adam J. Townsend: Further we are investing in direct to consumer marketing initiatives to increase patient awareness and education about <unk> and <unk>.
Adam J. Townsend: Suffice to say that our efforts are paying off in.
Adam J. Townsend: In the first quarter, we distributed 72000 commercial doses and 5000 samples.
Adam J. Townsend: The first three months of this year were the three largest volume months since launch through Q1. Growth rates varied monthly with a slight decline in February as compared to January, and then a re-acceleration in March, resulting in some of the largest demand weeks to date and our biggest month of the quarter.
Adam J. Townsend: The first three months of this year with the three largest volume months since launched through Q1.
Adam J. Townsend: Growth rates varied monthly with a slight decline in February as compared to January and then a reacceleration in March resulting in some of the largest demand weeks to date and our biggest month of the quarter.
Adam J. Townsend: Additionally, in Q1, we continue to see a double-digit number of new sites come on board each week, with over 2,000 sites of care now using CyFovery across a broad range of practice types. We are thrilled by the continued growth we have seen in the second quarter so far across both new and existing patients. It has been an incredible launch.
Adam J. Townsend: Additionally, in Q1, we continue to see a double digit number of new sites come onboard each week.
Adam J. Townsend: The 2000 sites of care now using <unk> across a broad range of practice types.
Adam J. Townsend: We are thrilled by the continued growth we have seen in the second quarter, so far across both new and existing patients.
Adam J. Townsend: And now that we are in its second year, we will be going back to sharing key metrics with you as the quarter ends. Regarding vasculitis, the rate remains rare at approximately 1 in 10,000 injections. What we have learned is that this appears to be a first injection phenomenon, with the rate following a first injection estimated at about one in four. Given the extensive real-world experience with cyphobrhea to date, retina specialists are more confident that these rates are rare and stable.
Adam J. Townsend: It's been an incredible launch and now that we're in its second year, we will be going back to sharing key metrics with you as the quarter end.
Adam J. Townsend: Regarding vasculitis.
Adam J. Townsend: <unk> remains at approximately one in 10000 injections.
Adam J. Townsend: What we have learned is that this appears to be upset injection phenomenon with.
Adam J. Townsend: With the right following a fast injection estimated to add about one in 4000.
Adam J. Townsend: Given the extensive real world experience with <unk> to date.
Adam J. Townsend: Retina specialists are more confident that these rates are rare and stable.
Adam J. Townsend: And we are seeing many physicians who have either paused or decreased their use now start to use cyfovery again or use it in more of their patients. Shifting gears to longer-term dynamics. Syphobia remains the number one chosen treatment for GA with approximately 85 percent of the treated market. We are confident that it will remain the market leader due to its strong efficacy, well-documented safety profile, flexible dosing, and the robustness of our overall data set.
Adam J. Townsend: And we are seeing many physicians, who had either paused or decrease that use now start to use <unk> again or use it in more of that patient.
Adam J. Townsend: Shifting gears to longer term dynamics.
Adam J. Townsend: <unk> remained the number one chosen treatment for GE with approximately 85% of the treated market.
Adam J. Townsend: We are confident that it will remain the market leader due to its strong efficacy while documented safety profile flexible dosing and the robustness of our overall dataset.
Adam J. Townsend: Even more, we are only in the early stages of a large and growing market. The estimated prevalence of GA patients is up to 1.5 million in the United States. Today, based on a recent claims analysis, patients treated are estimated to make up 12% of the market, as defined only by those patients who have been diagnosed and are managed by an ECP. However, many patients are not yet diagnosed or have not been referred to a specialist. In fact, only a small portion of newly diagnosed patients currently being treated with syphilis are referred by their doctors.
Adam J. Townsend: Even more we are only in the early stages of a large and growing market.
Adam J. Townsend: The estimated prevalence of Gi patients at up to $1 5 million in the United States.
Adam J. Townsend: Today based on our recent claims analysis patients treated are estimated to make up 12% of the market has defined only by those patients who have been diagnosed and are managed by an ECP.
Adam J. Townsend: However, many patients are not yet diagnosed or have not been referred to a specialist.
Adam J. Townsend: In fact, only a small portion of newly diagnosed patients currently being treated with tysabri.
Adam J. Townsend: This means there continues to be a huge opportunity for slyphovery as the vast majority of GA patients have not yet been treated. Now that we are in the year... We are executing the next stage of our commercial strategy. Remember, we are launching a transformative medicine for a disease that has never had a treatment available. So we have learned a lot about what drives both physicians and patients. Let me start with physicians.
Adam J. Townsend: <expletive>.
Adam J. Townsend: <unk> bank continues to be a huge opportunity at slide five.
Adam J. Townsend: As the vast majority of Gi patients have not yet been treated.
Adam J. Townsend: Now that we are in year two.
Adam J. Townsend: We are executing the next stage of our commercial strategy.
Adam J. Townsend: Remember, we are launching a transformative medicine for a disease that has never had a treatment available. So we have learned a lot about what drives both physicians and patients.
Adam J. Townsend: Let me start with physicians.
Adam J. Townsend: We plan to further increase our reach within existing physician targets, as well as expand our use amongst those who have not used SyphoBus. We are refining our messaging as we better understand what is responsive. At launch, our messaging initially focused on efforts..., then shifted to safety last summer.
Adam J. Townsend: We plan to further increase our reach within existing physician targets as well as expand our use amongst those who have not cute SIFI over yet.
Adam J. Townsend: We are refining our messaging as we better understand what is resonating.
Adam J. Townsend: At launch our messaging initiative focused on efficacy then shifted to safety last summer.
Adam J. Townsend: Now we have pivoted back to leading with efficacy, highlighting the positive results from our three-year Gale Extension Study, in addition to our Oakes and Derby data and the multiple post-hoc analyses that demonstrate functional benefits following cyfote retreat. We are also broadening our reach to provide disease state education to other referring eye care providers who see tens of thousands of GAPs. As the market leader, we are educating those doctors on the importance of G.A.
Adam J. Townsend: Now we have pivoted back to leading with efficacy highlighting the positive results from op III Gale extension study in addition to our Oaks and Derby data and the multiple post hoc analyses that demonstrate functional benefits following treatment.
Adam J. Townsend: Treatment.
Adam J. Townsend: We are also broadening our reach to provide disease education to other referring ICANN providers, who see tens of thousands of Gi patients.
Adam J. Townsend: treatment so that patients see a specialist who can then decide what is right for them. Moving to patients, another key learning over the past year is how motivated and actively engaged patients are in their treatment decisions. As you may have seen in our unbranded DTC campaign, our initial message was focused on increasing awareness of GMOs and encouraging patients to see their eye care doctor. These efforts have netted very positive results, including thousands of new GA diagnoses and a significant number of patients starting syphobic.
Adam J. Townsend: As the market leader, we are educating those doctors on the importance of Gi treatment for.
Adam J. Townsend: The patients see a specialist who can then decide the right treatment approach.
Adam J. Townsend: Moving to patients another key learning of the past year as how motivated and actively engaged patients are in that treatment decisions.
Adam J. Townsend: As you may have seen in our unbranded DTC campaign.
Adam J. Townsend: Initial message was focused on increasing awareness of Gi and encouraging patients to see that ICANN professional fees.
Adam J. Townsend: These efforts have netted very positive results, including thousands of new Gi diagnosis, and a significant number of patients starting SIFI pretreatment.
Adam J. Townsend: We recently launched a branded DTC campaign with a focus now on encouraging patients to talk to their physicians about GA treatment for syphilis. Our goal for this campaign is to increase awareness, reach many more patients, and accelerate the speed to diagnosis and treatment of G.A. Now, let me shift to M. Paveli for PN. Revenues in the quarter were $26 million.
Adam J. Townsend: We recently launched a branded DTC campaign with the focus now on encouraging patients to talk to that physicians about Gi treatment with psychiatry.
Adam J. Townsend: Gulf of this campaign is to increase the awareness that's.
Adam J. Townsend: Many more patients and accelerate the speed to diagnosis and treatment of gea.
Adam J. Townsend: Now, let me shift to <unk> P M H.
Adam J. Townsend: Revenues in the quarter were $26 million compliance.
Adam J. Townsend: Compliance rates remain incredibly high at 97%, and the product also continues to have a compelling safety profile. With over 1,600 patient years of systemic pegcetococcal and exposure, there have still been zero cases of meningococcal infection and very low rates of thrombosis. But obviously, we are now seeing heightened competition. With a new entrant in the market, we anticipate pressure on Empaveli sales for the next six to 12 months. Although we have a strong foothold, I want to be realistic and say that demand is expected to be flat in the median term.
Adam J. Townsend: Compliance rates remain incredibly high at 97% and the product also continues to have a compelling safety profile.
Adam J. Townsend: We've added 1600 patient years of systemic <unk> exposure, there still been zero cases of Meningococcal infection, and very low rates a firm basis.
Adam J. Townsend: But obviously, we are now seeing heightened competition.
Adam J. Townsend: With a new entrant in the market, we anticipate pressure on NPV value sales at least for the next six to 12 months.
Adam J. Townsend: Although we have a strong foothold I want to be realistic that the bond is expected to be flat in the medium term.
Adam J. Townsend: We still expect to see new patients starting treatment, but we also expect to see some patients switching to oral. The Ampivelli team is laser-focused on emphasizing the real-world profile of Ampivelli with physicians, including its three-year efficacy data and strong safety profile. We have confidence that this profile will drive some physicians and patients to return to emphybellia over time. While still very early, we've already seen a few instances of this.
Adam J. Townsend: We still expect to see new patients starting on treatment, but we also expect to see some patient switching to an oral.
Adam J. Townsend: The <unk> team is laser focused on emphasizing the real wild profile of empathetic with physicians.
Adam J. Townsend: <unk> at three efficacy data and strong safety profile.
Adam J. Townsend: We are confident that this profile will drive some physicians and patients to return to empathetic overtime.
Adam J. Townsend: While still very early we've already seen a few instances of this.
Adam J. Townsend: Finally, we are particularly excited about the opportunity to potentially expand Empaveli into C3G and primary ICM-PG. These are two devastating diseases with tremendous unmet need and a patient population that is three times bigger than P&H. If approved, we will be able to leverage much of our existing infrastructure, such as utilization of our field-based teams to reach nephrologists and deliver Empavelita patients and physicians. Caroline will give more detail on the opportunity we have for these. Caroline
Adam J. Townsend: Finally, we are particularly excited about the opportunity to potentially expand <unk> into <unk> and primary ICM PGM.
Adam J. Townsend: These are two devastating diseases with tremendous unmet need and a patient population that is three times bigger than <unk>.
Adam J. Townsend: If approved we will be able to leverage much of our existing infrastructure.
Adam J. Townsend: Such as utilization of our field base teams to reach Nephrologists and deliver <unk> to patients and physicians.
Adam J. Townsend: Caroline will give more detail on the opportunity we have for these diseases.
Caroline R. Baumal: Thanks, Adam, and good morning, everyone. Yes, we are really looking forward to the top line data from our Phase 3 Valiance Study in C3G and IC-MPGN, which we expect in mid-2024. I'm going to focus my remarks today on this upcoming development milestone, providing some background on the patient population, as well as on the study. C3G and ICMPGN are debilitating kidney diseases caused by uncontrolled complement activation and breakdown of C3. Symptoms include protein and blood in the urine, swelling, fatigue, and high blood pressure.
Adam J. Townsend: Caroline.
Caroline: Thanks, Adam and good morning, everyone.
Caroline: Yes, we are really looking forward to the top line data from our phase III <unk> study.
Caroline: <unk> and IC and PGN, which we expect mid 2024.
Caroline: I'm going to focus my remarks today on the upcoming development milestones, providing some background on the patient population as well as on the study.
Caroline: And ICEE and PGN debilitating kidney diseases caused by uncontrolled complement activation can breakdown of Q3.
Caroline: Symptoms include protein in blood and urine swelling fatigue and high blood pressure.
Caroline R. Baumal: These diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe, with the first diagnosis typically occurring in adolescence. Within 5 to 10 years of diagnosis, approximately 50% of people living with C3G and ICMPGN ultimately suffer from kidney failure, resulting in either a kidney transplant or lifelong dialysis, both of which are highly burdensome and life-threatening to the patient. However, neither are curative, and there are no approved treatments for these diseases.
Caroline: These diseases are estimated to affect 5000 people in the United States.
Caroline: Up to 8000 in Europe.
Caroline: With the first diagnosis typically occurring in adolescence.
Caroline: Within five to 10 years of diagnosis.
Caroline: And at least 50% of people living with both <unk> and.
Caroline: And I see and PGN ultimately suffer chronic kidney failure, resulting in either kidney transplant or <unk>.
Caroline: <unk> long dialysis.
Caroline: Both of which are highly burdensome and life threatening to the patient.
Caroline: However, neither are curative and there are no approved therapies for the Parisian.
Caroline R. Baumal: The incidence of disease recurrence is high, and up to 50% of patients lose their kidney transplants due to disease recurrence. Some patients may have multiple transplants in their lifetime, depending on their age at the first diagnosis. The Valiant Study enrolled 124 patients with either C3G or primary IC MPGN in a randomized, placebo-controlled, double-blinded, multi-center study designed to evaluate pegcetacopalin efficacy and safety. It is the only Phase III study to include a broad population, inclusive of adolescent and adult patients, with native and post-transplant forms of both diseases. Study participants were randomized one-to-one to receive Pegcetacopalin or placebo twice weekly for 26 weeks. Following this 26-week period, patients moved to a 26-week open-label phase in which all patients received Pegcetacopalin.
Caroline: Yes.
Caroline: The incidence of disease recurrence is high and up to 50% of patients lose their kidney transplants.
Caroline: This disease recurrent.
Caroline: Some patients may have multiple transplants in our lifetime, depending on their age at first diagnose it.
Caroline R. Baumal: The primary endpoint is a log-transformed ratio of urine protein to creatinine ratio, or UPCR, a key marker of disease progression in all patients at week 26 compared to baseline. Physicians consider a statistically significant response to the primary endpoint as clinically meaningful in this disease. Key secondary endpoints include additional measures on both UPCR and EGFR. We are very excited about the potential opportunity that Pegcetacopalin may have for patients with C3G and ICMPGN.
Caroline: The value study enrolled 124 patients with either <unk> or primary IC and PGN in a randomized placebo controlled double blinded multicenter study designed to evaluate pacesetter Copeland efficacy and safety.
Caroline: It is the only phase III study to include a broad population.
Caroline: Mr of adolescent and adult patients with native and post transplant forms of both diseases.
Caroline: Study participants were randomized one to one to receive <unk> Copeland or placebo twice weekly for 26 week.
Caroline: Following the 26 week period patients move to a 26 week open label phase in which all patients received <unk> medical plan.
Caroline: The primary endpoint is a lot of transformed ratio of urine protein creatinine ratio or <unk>.
Caroline: <unk> PCR a key marker of disease progression and all.
Caroline: All patients at week 26 compared to baseline.
Caroline: Physicians consider a statistically significant response to the primary endpoint as clinically meaningful.
Caroline: <unk>.
Caroline: Key secondary endpoints include additional measures of both new PCR and Egfr.
Caroline: We are very excited about the potential opportunity that pegs Copeland may have on patients with <unk> and IC and PJM.
Caroline R. Baumal: Turning to syphilis briefly, we participated in several global medical meetings over the past few months. The retina community has been highly engaged with the Apellis team, especially regarding our latest data from the Gale study, which demonstrated up to 42% slowing of GA growth in year three in non-symphobial patients compared to projected sham. These increasing effects have never been shown before in any GA study.
Caroline: Turning to stifle very briefly we participated in several global medical meetings over the past few months.
Caroline: The retina community has been highly engaged with the appellate team, especially regarding our latest data from the <unk> study, which demonstrated up to 42% slowing of growth in year, three and non control, we'll patients compared to projected sham.
Caroline: These increasing effect has never been shown before in any study.
Caroline R. Baumal: Finally, before I hand it over to Tim, I want to extend a warm welcome to Dr. Phil Ferron, who joins us as our Chief Medical Retina Advisor. I have known Phil for a long time, having worked on multiple clinical trials and other programs together throughout our careers. Phil is a leading figure within the medical community with deep expertise in patient care and retina research. He is also a past president of the ASRF and has been on its board for 18 years.
Speaker Change: Finally, before I hand, it over to Tim I want to extend a warm welcome to Dr yourself around who joins us as our chief medical retina adviser.
Timothy E. Sullivan: I have known felt for a long time, having worked on multiple clinical trials and other program together throughout our careers.
Timothy E. Sullivan: Bill is a leading figure within the medical community with deep expertise in patient care and retina research.
Timothy E. Sullivan: He is also a past president of the Srs and has been on its board for 18 years.
Caroline R. Baumal: Given Phil's in-depth experience with syphovir and overall retina experience, he is uniquely positioned to help us continue to bring syphovir to GA patients and develop our retina pipeline. I know I speak for all of us at Apellis when I say we are thrilled to have him on board. Now, I will turn the call over to Tim for a review of the financials.
Timothy E. Sullivan: So in depth experience with Tysabri and overall retina experience. He is uniquely positioned to help us continue to bring high celebrate PGA patient and develop our retina pipeline.
Speaker Change: I know I speak for all of Us at a palace when I say, we are thrilled to have him on board.
Timothy E. Sullivan: Now ill turn the call over to Tim for a review of the financial.
Timothy E. Sullivan: Tim.
Timothy E. Sullivan: Caroline, I will provide a brief overview of our financials, and you can find additional details in the press release that we issued earlier this morning. Total revenue for the first quarter of 2024 was $172.3 million, including $137.5 million in Syfovery and $25.6 million in Empa-Valley U.S. net product revenue. This compares with $44.8 million in total revenue in the first quarter of 2023. Turning to the rest of the P&L, for the first quarter, cost of sales was $20.2 million.
Timothy E. Sullivan: Thank you Caroline.
Timothy E. Sullivan: I will provide a brief overview of our financials and you can find additional details in the press release that we issued earlier this morning.
Timothy E. Sullivan: Total revenue for the first quarter, 2024 was $172 3 million, including $137 $5 million in <unk> and $25 6 million in <unk> U S net product revenue.
Timothy E. Sullivan: This compares with $44 8 million in total revenue in the first quarter of 2023.
Timothy E. Sullivan: Turning to the rest of the P&L for the first quarter cost of sales was $20 2 million R&D expenses were $84 $7 million.
Timothy E. Sullivan: The reason R&D expenses are slightly higher in Q1 versus Q4 is because there was a $15 million onetime noncash expense in Q1 related to the discontinuation of <unk>.
Timothy E. Sullivan: R&D expenses were $84.7 million. The reason R&D expenses are slightly higher in Q1 versus Q4 is because there was a $15 million one-time non-cash expense in Q1 related to the discontinuation of CAD. SG&A expenses were $129.5 million, and we reported a net loss of $66.4 million.
Timothy E. Sullivan: SG&A expenses were $129 5 million and we reported a net loss of $66 4 million.
Timothy E. Sullivan: While R&D and SG&A may fluctuate on a quarterly basis, we continue to expect our total operating expenses for the full year 2024 to be less than our total expenses in 2023. Turning to our balance sheet, as of March 31st, 2024, we had $326 million in cash and cash equivalents. As Cedric mentioned, we are in a strong position financially with our existing cash combined with projected revenues. We continue to believe that we have sufficient cash to fund our operations for the foreseeable future.
Timothy E. Sullivan: While R&D and SG&A may fluctuate on a quarterly basis, we continue to expect our total operating expenses for the full year 2024 to be less than our total expenses in 2023.
Timothy E. Sullivan: Turning to our balance sheet as of March 31, 2024, we had $326 million in cash and cash equivalents.
Timothy E. Sullivan: As Cedric mentioned, we are in a strong position financially with our existing cash combined with projected revenues. We continue to believe that we have sufficient cash to fund our operations for the foreseeable future.
Cedric Francois: I will now hand the call back over to Cedric for closing remarks. Cedric? Thanks. We are hiding.
Timothy E. Sullivan: Now hand, the call back over to Cedric for closing remarks Cedric.
Cedric Francois: Thanks, Tim. We are highly encouraged by the start of 2024 and excited for the value-driving milestones on the horizon. I want to emphasize our determination to be the leader in complement medicine. Progress across our pipeline, exemplified by, but not limited to, Saifovri and Mbavedi, is presenting us with opportunities to create meaningful therapies and substantial value for shareholders. We appreciate your continued support, and we truly believe that the best is yet to come. Let us now open the call for questions. Operator?
Cedric Francois: Thanks, Tim we are highly encouraged by the start of 2024 and excited for the value driving milestones on the horizon.
Cedric Francois: I want to emphasize our determination to be the leader in complement to medicine.
Cedric Francois: The progress across our pipeline exemplified by but is not limited to say food and beverage is presenting us with opportunities to create meaningful therapies and substantial value for shareholders.
Timothy E. Sullivan: We appreciate your continued support.
Cedric Francois: Truly believe the best is yet to come.
Speaker Change: That is now open the call for questions operator.
Operator: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. In the interest of time, we ask that you please limit yourselves to one question and one follow-up. Please stand by while we compile the Q&A ROST. Our first question comes from Umer Raffat with Evercore ISI. Your line is now open.
Cedric Francois: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again in.
Cedric Francois: In the interest of time, we ask that you. Please limit yourself to one question and one follow up.
Cedric Francois: Please standby, while we compile the Q&A roster.
Cedric Francois: Our first question comes from <unk> <unk> with Evercore ISI. Your line is now open.
Cedric Francois: Hi, guys. Thanks for taking the question its actually John Miller on for Amit here.
Umer Raffat: I would love to start with the competitive dynamics in GA. Obviously, we heard recently from your recently launched competitor that they expect to see 25% market share already and go to 40% by the end of the year. That doesn't jive with what you just told us, saying you have 85% market share, so maybe you could put into context some of the differences, how we square that circle with the market share that they reported versus what you reported, and maybe a little bit about how you expect competitive dynamics in GA to evolve over the course of the year as a new competitor launches.
John Miller: I would love to start with the competitive dynamics in GAA.
John Miller: Obviously, we heard recently from your recently launched competitor.
John Miller: They expect to see 25% market share already and go into 40% by the end of the year.
John Miller: That doesn't Jive with what you just told US you're saying you have 85% market share. So if maybe you could put into context.
John Miller: Some of the differences how do we square that circle with the market share that they reported versus your reported and maybe a little bit about how you expect competitive dynamics in Gi to evolve over the course of the year.
John Miller: As a new competitor launches.
Cedric Francois: Thank you, John. It's great to hear from you.
Speaker Change: Thank you John Great to hear you Adam.
Adam J. Townsend: Thanks, John. It's Adam.
Adam J. Townsend: Adam? Thanks, John. It's Adam.
Adam J. Townsend: So yeah, first of all, we are thrilled with the 20% growth we saw in Q1 versus Q4. Obviously, there are many ways to estimate market share, and what we do here is that we look at market share in terms of patients treated with GA. We think it's the most robust way of measuring market share, because you then know that the drug is actually being used by a patient.
Speaker Change: Thanks, John it's Adam so yeah.
Adam J. Townsend: We are thrilled with the 20% growth we saw in Q1 versus Q4 so.
Speaker Change: Obviously, there are many ways too.
Speaker Change: Estimate market share and what we do here is that we we look at market share as patients treated with <unk>.
Speaker Change: We think is the most robust way of measuring market share than that.
Speaker Change: The drug is actually being used within a patient.
Adam J. Townsend: A standard calculates market share based on vials distributed. So again, patients are the number one choice for us when it comes to market share. It means you can rule out things like vials at wholesalers, vials in hospital fridges, and doctors' fridges. And also, it accounts for frequency of administration, right?
Speaker Change: This is Dennis calculate market share thats based off of bile distributed.
Speaker Change: So again patience is the number one choice for us when it comes to market share. It means you can roll out things like <unk> that wholesalers vials in hospital fridges and doctors fridges and also it accounts for frequency of administration right. We are tend to be a very much strong every other month drugs and.
Adam J. Townsend: We tend to be a very strong every-other-month drug. And by looking at patients, you can be much more specific than that. So with number one chosen GA therapy, I continue to see that progressing as we progress through the year. This is a massive market. We've chosen first among new patients and continued physicians' choice. We have the potential to be a multibillion-dollar product in the U.S., and I expect that to continue as we push to execute our plans for the rest of the year.
Speaker Change: By looking at patients you can be much more specific than that so we're the number one chosen <unk> therapy.
Speaker Change: Continue to see that progressing as we progressed through the year. This is a massive market with chosen fast across new patients and continued physician's choice.
Speaker Change: We have the potential to be a multibillion dollar product in the U S and I expect that to continue as we push to execute our plans for the rest of the year.
John Miller: I think that that makes a ton of sense. And I guess as we think about moving beyond that US market, which, as you say, is very robust, I have a question about the EU process that now seems to have been restarted or set back or or gone back to the original rapporteurs. Can you just give us the bottom line for us? Is that good news or bad news? Does this increase the likelihood or decrease the likelihood of you actually getting approved at some?
Speaker Change: Alright, Thanks that makes a ton of sense and I guess as we think about <unk>.
Speaker Change: Moving beyond that U S market, which as you say is very robust.
Speaker Change: I have a question about the EU.
Speaker Change: Process, but now it seems to have been restarted or is that back or.
Speaker Change: Or gone back to the original <unk> can you just bottom line for US is that good news or bad news does this increase the likelihood or decrease the likelihood of you actually getting approved at some point.
Cedric Francois: Thank you, John. In terms of the odds of approval, quite frankly, we think nothing has changed. This is a procedural delay that was caused by a lawsuit that had nothing to do with us, between the EU and another company. So we're going to have to wait a little bit longer, but we think that the odds of approval stay the same.
Cedric Francois: Thank you, John.
Speaker Change: Thank you John.
Speaker Change: In terms of the also the approval quite frankly, we think nothing has changed.
Speaker Change: As a procedural.
Speaker Change: The delay that was caused by.
Speaker Change: The loss of that had nothing to do with us between the EU and another company.
Speaker Change: So we're going to have to wait a little bit longer, but we think that the other the profitability stay the same.
Speaker Change: Alright, thanks very much.
Operator: One moment for our next question. Our next question comes from Tazeen Ahmad with Bank of America Securities. Your line is now open.
Speaker Change: Thank you. Thank you.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from them.
Speaker Change: <unk> Ahmad with Bank of America Securities. Your line is now open.
Tazeen Ahmad: Hi guys, good morning, and thanks for taking my question. I just wanted to get a sense about how you're seeing the rate of growth.
Ahmad: Hi, guys. Good morning, and thanks for taking my question.
Ahmad: Got it.
Ahmad: About how Europe.
Ahmad: Great.
Ahmad: Yeah.
Cedric Francois: 1Q. We know that you had an impact. Transcripts provided by Transcription Outsourcing, LLC.
Speaker Change: We know that you had in past.
Speaker Change: Yeah.
Speaker Change: Sure.
Speaker Change: Read that but now that that's largely or completely behind you can you talk about the general rate of growth on whether or not the rate of growth.
Speaker Change: So flatline or you know what he was going to be a seasonal effect going forward.
Cedric Francois: Thank you so much, Ced. You were breaking up a little bit. I think your question was whether the rate of growth continues to be in line with what it was before, right?
Speaker Change: Thank you. So much says you were breaking up a little bit I think your question was whether the rate of growth continues to be in line with what it was before for safe low risk right.
Tazeen Ahmad: Yeah, with the exception of 1Q being impacted by the insurance reception.
Speaker Change: When do you expect sort of <unk> being impacted with the insurer.
Adam J. Townsend: Okay, yes, excellent. Thank you, Adam. Thanks, Tazeen. So, yeah, for us...
Speaker Change: Okay excellent. Thank you.
Adam J. Townsend: Thanks, Adam. Thanks, Tazeen.
Speaker Change: Thanks, <unk>, so yes for us to see 20% quarterly growth one year into the launch I think it is an incredible indicator long term success.
Adam J. Townsend: So yeah, for us to see 20% quarterly growth one year into the launch, I think it's an incredible indicator for long-term success. Also, remember that last year, October to December, we had a better understanding of our efficacy profile with the three-year Gale data in November, and we're going to continue to push that for the remainder of the year. This large market, we believe, is driven by efficacy. We're incredibly well positioned for strong future growth, both in the near term and the long term. And we continue to see that strong growth into Q2, and we're excited for our next earnings report, where we can share a lot more details about that.
Speaker Change: Also remember that last year October to December we had a better understanding of the efficacy profile with the three year Gail data in November and we're going to continue to push that for the remainder of the year. This large market. We believe is driven by efficacy.
Speaker Change: We are incredibly well positioned for strong future growth both in the near term and the long term.
Speaker Change: We continue to see that strong growth into Q2 and into Q2 and we're excited for our next earnings call, where we can share a lot more details about that.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Okay.
Speaker Change: Our next question comes from.
Operator: Thank you. One moment for our next question. Our next question comes from Anupam Rama with J.P. Morgan. Your line is open. Hey guys, this is Priyanka on.
Speaker Change: <unk> Rama with Jpmorgan Your line is open.
Speaker Change: Hey, guys. This is priyanka on for Anil and just building up a little bit on the first question. How are you thinking about the dynamics around the November regulatory action for either it may and what various scenarios could due to market share. Thanks.
Anupam Rama: Thank you so much for that question. We do not want to comment on our competitor. You would have to ask them about that.
Jpmorgan: Thank you so much for that question.
Speaker Change: Do not want to comment on our competitor you would have to ask.
Cedric Francois: But of course, these are all elements that will factor into where the landscape ends. I think what really stands out here is that this market is absolutely enormous, unfortunately, because there are so many patients and we have only begun this question.
Speaker Change: Yes.
Speaker Change: But of course these are all elements that will factor into where ultimately landscape I think what really stands out here is that this market is absolutely enormous.
Speaker Change: Firstly, because there are so many patients and we have only begun discretion sir.
Speaker Change: Got you. Thanks, so much.
Operator: Thank you. One moment for our next question. Salveen Richter with Goldman Sachs, your line is now open.
Speaker Change: Thank you.
Speaker Change: One moment for our next question.
Speaker Change: Yeah.
Speaker Change: Our next question comes from.
Speaker Change: <unk> Richter with Goldman Sachs. Your line is now open.
Richter: Good morning, Thanks for taking my question could you just speak to the magnitude of seasonality impact in the first quarter and then regarding your launch here, maybe help us understand in the first quarter.
Speaker Change: What.
Richter: New prescribers and new patients looked.
David Richter: It looked like in terms of uptake here and as well as follow up doses. Thank you.
Salveen Jaswal Richter: Thank you, Salveen. Great to hear from you, Adam. Thanks, Salveen. So, yeah, March was the...
Speaker Change: Thank you Sylvie and great to hear you Ed.
Adam J. Townsend: Thanks, Salveen. So yeah, March was the strongest month for our first quarter. So February dipped a little bit. And as you know, this is the first time we learned about seasonality with cyphovesy with all of the work that we did for insurance recertifications, plus the impact of storms. Regardless of that, et cetera, and that seasonality, we still saw great, strong growth. So, and we're seeing that growth continue into Q2. As Cedric said earlier in the previous question, this is an incredibly big market in which we think the profile of our drug with strong efficacy, well-documented safety, flexible dosing, and the unmatched data that backs all of that up is going to be incredibly strong for us moving forward. In Q2, the team is laser focused on executing our plan, and we are the number one picked GA treatment.
Speaker Change: So yes March was the strongest month for us.
Speaker Change: First quarter, So February dipped a little bit and as you know right. This is the first time, we learn about seasonality with <unk> with all of the work that we did for insurance resets vacations.
Richter: The impact of storms.
Richter: I can I'll stick to that et cetera, and that seasonality, we still saw great strong growth.
Richter: And we're seeing that growth continue into Q2.
Richter: As Cedric had said earlier in the previous questions. This is an incredibly big market of which we think the profile of our drug with its strong efficacy while documented safety flexible dosing and the unmatched data that backs all of that up is going to be incredibly strong for us moving forward.
Richter: Q2, the team is laser focused on executing our plan and we are the number one pick Gi treatment.
Operator: Thank you. One moment for our next question, and our next question comes from Yigal Nochomovitz with Citigroup. Your line is now open.
Richter: Thank you one moment for our next question.
Richter: Yeah.
Richter: And our next question comes from Yigal <unk> with Citigroup. Your line is now open.
Yigal Dov Nochomovitz: Guys, thank you so much for taking the questions. I had a few, Adam, on some of the commercial dynamics.
Yigal: Got it. Thank you so much for taking the questions I had a few add them on some of the commercial dynamics can you comment at all on switching rates either from <unk> or vice versa. And then you mentioned there are about 2000 sites of care that you've already seen uptake could you comment what percent of those are exclusively stocking sofa.
Yigal Dov Nochomovitz: Could you comment at all on switching rates either from Isovay to Cyfoavir or vice versa? And then you mentioned there are about 2,000 sites of care where you've already seen uptake. Could you comment on what percent of those are exclusively stocking Cyfoavir, or is there a fraction that's stocking both drugs, and is there a fraction that's just stocking Isovay? And then you mentioned that the rate following the first injection on ROV was one out of 4,000.
Richter: Over or is there or is there a fraction that stocking both drugs and is there a fraction thats just stocking.
Richter: Survey and then.
Yigal Dov Nochomovitz: I'm not sure if I misheard that. Can you just comment, was it one out of 4,000 or a different number? I would have thought it would have been lower if it was the first injection phenomenon with a rate of 0.01.
Richter: You had mentioned that the rate following the first injection in <unk>.
Richter: One out of 4000, I'm not sure if I misheard that but could you just comment on that one out of 4000 or a different number I would've thought it would've been lower if it was the first injection phenomenon right and the point I want thanks.
Adam J. Townsend: Yeah, Yigal, so switching, so again, we have the strong majority of new patient starts choosing Cyfobrine. No surprise, right? The Isovase J-code is now in action.
Richter: Yes.
Richter: So switching so again, we have the strong majority of new patient starts they choose SIFI Aubrey.
Richter: No surprise right <unk> J code is now interaction we will see some fluctuations on your stocks as we did with our J code.
Adam J. Townsend: We'll see some fluctuations on new starts, as we did with RJ-code. However, a strong majority of new starts choose SIFO, and I think that's a very positive metric moving forward. Yes, we have over 2,000 sites of care, and my very nerdy metric continues to show that we get double-digit new sites starting cyfovery every week, and that has been the same since the beginning of the launch. That's a very strong indicator of demand.
Richter: But.
Richter: The strong majority of new starts G. SIFI I think that's a very positive metric moving forward.
Speaker Change: Yes, we have two that opened 2000 sites of care in my very near the metric continues that we get double digit new site starting site Bovary every week and that has been the same since the beginning of the launch.
Adam J. Townsend: Some sites share both drugs. There are certain sites that are cyfovery-only sites, predominantly cyfovery. We tend to choose cyfovery for the efficacy of the drug and the data sets that support that efficacy. There are one or two sites that during vasculitis did switch to Isovay, but we've also started to see those sites come back, and we've started to see physicians who did pause during last year's vasculitis conversation have started to come back too. So the trends are very positive for what is going to be a very large opportunity in GX. Oh, you also had a question about fattening the lysis rate. Yeah, I was on, I wasn't there, thanks.
Richter: Very strong indicator of demand.
Richter: Some sites share buybacks drugs, there are certain sites that.
Richter: <unk> only sites predominantly FIFO read they tend to choose <unk> for the efficacy of the drug.
Richter: And the data set that supports the efficacy there are one or two sites that during vasculitis did switch to either way.
Richter: But we've also started to see those sites come back and we started to see physicians, who did pause during last year's vasculitis conversation have started to come back to so the trends are very positive.
Richter: What is going to be a very large opportunity in Gi.
Richter: You also had a question on <unk>.
Speaker Change: That is right.
Speaker Change: Thanks.
Cedric Francois: Yeah, sorry, Yigal. Hi, this is Cedric. So, the rate has been. Thank you very much.
Speaker Change: Yes, sorry, you go ahead the subsidiary so so the rate has been.
Speaker Change: Stable since the very beginning at about one in 10, thousands and this is predominantly a first injections phenomenon.
Speaker Change: There are about one in 4000 shares in the same range of what you would find for example, infectious endophthalmitis.
Cedric Francois: But it is really that first injection. So if you are a physician with a patient, that is a conversation that you can have. After that, we believe that the very low vasculitis rate is in line with what you would find.
Speaker Change: But it is really that first injection. So if you are a physician with a patient that is a conversation that you can have after that we believe that the very low vasculitis rate isn't that with what it was the same store visits.
Yigal Dov Nochomovitz: Oh, I understand what you're saying. I thought you said the one in 4000 was for the second and third and subsequent injections, but it's for the first. I understand. Thank you.
Speaker Change: Oh, I understand what Youre, saying I thought you said the one in 4000 was further for the second and third.
Speaker Change: And subsequent but it's for the first I gotcha. Thank you.
Cedric Francois: Correct. Right. Yep. Yep.
Speaker Change: <unk> injection.
Speaker Change: Right Yep Yep.
Operator: Thank you. One moment for our next question. And our next question comes from Steve Seedhouse with Raymond James. Your line is now open. Hi, thank you. This is Nick on behalf of Steve. We just wanted to clarify.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Okay.
Speaker Change: And our next question comes from Steve <unk> with Raymond James Your line is now open.
Speaker Change: Alright. Thank you. This is Nick on for Steve. We just wanted to clarify if you are able to submit new data, whether it's long term deal data functional analyses.
Nick: Our real World safety data as part of the updated review process in Europe. Thank you.
Steven Seedhouse: Thank you so much, Steve. So we are, you know, allowed to make changes and submit new data as part of the first review. It is in the appeals process that that is not allowed.
Speaker Change: Thank you so much Steve So we are.
Speaker Change: It allowed us to make changes and submit new data start of the first review.
Speaker Change: It is in the appeals process that is not allowed.
Cedric Francois: And one quick follow-up. Are you able to comment on how many patients have been treated with Cypover to date? That is not a number that we provide.
Speaker Change: Alright, Thank you and one quick follow up are you able to comment on how many patients have been treated with swipe over to date.
Speaker Change: That is not a number that will be proven.
Speaker Change: Alright, thank you.
Speaker Change: Thank you.
Operator: Thank you. One moment for our next question. Our next question comes from Colleen Kusy with Bayer.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from calling <unk> with Baird. Your line is now open.
Colleen Margaret Kusy: Your line is now open. Great. Good morning. Thanks for taking time.
Baird: Great. Good morning, Thanks for taking our questions.
Baird: Adam you commented on a slight dip in February is that a fair.
Baird: Doctor of every eight week dosing or kind of what you think was driving that slight dip and then can you just comment on inventory in the quarter I think our math is showing a slight drawdown in the quarter, but could you just comment please.
Adam J. Townsend: Hey, Colleen. Yes. So, yeah, I mean, obviously, February was a shorter month. And I think there's always a little bit of seasonality in January, February, and March, as we've seen. But we picked straight back up in March and continue to see growth into Q2. Now, you know, we previously announced in mid-February 40,000 doses. And just to add a little bit of context to your question, that was within the first seven weeks of a 13-week quarter. We then saw an additional 37,000 doses distributed across the remaining six weeks.
Adam J. Townsend: Hey, Kelly, yes so.
Kelly: Yes, I mean, obviously February was a shorter month end.
Kelly: I think there's always a little bit of seasonality in January February and March that we've seen but we pick straight back up in March and continued to see growth.
Kelly: Into Q2 now.
Kelly: We previously announced mid February 40000 doses, and just add a little bit of context to your question that was within the first seven weeks of the third.
Kelly: Weak quarter. We then saw an additional 37000 doses distributed across the remaining six weeks so.
Adam J. Townsend: So that just shows you a little bit about the timing of those type of announcements and the seasonality within. What was the second part of your question? I just didn't catch it. [inaudible] Yeah. Oh, drawdown of inventory. We did see certain wholesalers draw down inventory. And we, you know, that's, again, normal as part of the seasonality of the month. Great, thank you.
Kelly: That just shows you a little bit about that the timing of those type of announcements and the seasonality within.
Speaker Change: What was the second part of your question I didn't catch it.
Speaker Change: Drawdown of inventory.
Speaker Change: Yes.
Speaker Change: Our drawdown of inventory.
Speaker Change: We did see we did see certain wholesalers draw down inventory and we.
Speaker Change: Again normal as part of the seasonality of the month.
Speaker Change: Great. Thank you.
Operator: Thank you. One moment for our next question. Our next question comes from Philip Nadeau with TD Cowan. Your line is now open.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from.
Speaker Change: Phil Nadeau with TD Cowen Your line is now open.
Philip M. Nadeau: Good morning. Thanks for taking our questions. One from us and a follow-up. On future trends, there seems to be a lot of focus among investors on what Isor Ray is going to do to your growth in future quarters. I know you've expressed confidence that you'll continue to grow given the size of the market, but I think people are debating whether the current consensus is achievable.
Philip M. Nadeau: Good morning, Thanks for taking my questions.
Philip M. Nadeau: One from US and then a follow up on the.
Philip M. Nadeau: Future trends this seems to be a lot of focus among investors on what is the rate is going to do to your growth in future quarters. I know you've expressed confidence that you will continue to grow given the size of the market.
Philip M. Nadeau: I think people are debating whether.
Philip M. Nadeau: Current consensus is achievable and it looks like for Q2, and Q3 consensus calls for 11% to 12% growth quarter over quarter in both those quarters. It seems like a meaningful deceleration compared to what you should hear in Q1. So is that is that reasonable is that conservative is there aggressive based on your expectations and what you've seen thus far.
Philip M. Nadeau: During Q2.
Philip M. Nadeau: It looks like for Q2 and Q3, consensus calls for 11% to 12% growth, quarter over quarter, in both those quarters, which seems like a meaningful deceleration compared to what you showed here in Q3. Is that reasonable? Is that conservative? Is that aggressive based on your expectations and what you've seen thus far in Q2?
Speaker Change: Thank you so much Phil Adam Yes, thanks, Phil so 20% growth.
Speaker Change: Q1 versus Q4, I think is a very positive thing and we continue to seeing growth into Q2 strong growth. We don't comment on what that growth will look like for the full quarter. We're excited to be able to represent that at our next earnings call.
Speaker Change: That's fair enough and then just one follow up on the EU.
Speaker Change: Could you get a negative future P opinion in <unk>.
Speaker Change: Do you still have the appeals process available to you could you could you go down the same road that you thought youre going to go down back in January once once this review is over.
Adam J. Townsend: Thank you so much, Phil. Adam? Yeah, thanks, Phil.
Speaker Change: Thank you Phil Yes, we can so as I mentioned before the process it will be longer, but we believe that the ability to stay the same.
Speaker Change: Thanks for taking my questions.
Speaker Change: Thank you.
Speaker Change: Thank you one moment for our next question.
Speaker Change: And our next question comes from.
Jefferies: Our cash <unk> with Jefferies. Your line is now open.
Ivy: Hello. Good morning. This is ivy on for our cash we have.
Ivy: Have a couple of quick ones also foray. So first is on safety what is the current hypothesis on the causes behind the cases have you done any testing.
Adam J. Townsend: So 20% growth, Q1 versus Q4, I think is a very positive thing, and we continue to see growth into Q2, strong growth. We don't comment on what that growth will look like for the fall quarter, but we're excited to be able to present that on our next earnings call.
Ivy: Antibodies and then on the competitive landscape if theres no more retinal vasculitis cases for either way over the next two quarters, how would your internal market share projections chip.
Philip M. Nadeau: That's fair enough. And then just one follow-up on the EU. Should you get a negative CHMP opinion in July? Do you still have the appeals process available to you? Could you go down the same road that you thought you were going to go down back in January once this review is over?
Ivy: Finally, it's borgwarner branded DTC campaign.
Ivy: What's the ROI, you're targeting AD and also like what's the spend associated with those campaigns ready Sir thanks.
Cedric Francois: Thank you, Phil. Yes, we can. So, as I mentioned before, the process will be longer, but we believe that the odds of approval stay the same. Perfect.
Speaker Change: Thank you so much and wonderful to hear you. So first of all on the hypothesis.
Speaker Change: As we've discussed before.
Speaker Change: It is pretty remarkable that there was this first injection phenomenon Reds from an immunological perspective, our leading hypothesis as you correctly mentioned is indeed around polyethylene glycol that doesn't work that we will continue to do to further explore.
Cedric Francois: Perfect. Thanks, Steve. Thank you.
Operator: Thank you. One moment for our next question, and our next question comes from Akash Tewari with Jefferies. Your line is now open.
Speaker Change: Now for our competitor, we will see where things land I think what is really important for us is that the rates of vasculitis is extremely low and stays extremely low as a first injection phenomenon.
Speaker Change: And the efficacy is something that of course, it really stands out for sexual re versus our competitor, which at the end of the day, we think will be the most important.
Speaker Change: All of this in the background of course of this enormous market that geographic atrophy represents because of the enormous amount of patients that are unfortunately affected by this disease.
Speaker Change: So as it relates to the DTC campaign that let me hand, it over to Adam, Yes, Ivy and I'll just add.
Akash Tewari: And then on the competitive landscape, if there are no more retinal vasculitis cases for either way over the next two quarters, how would your internal market share projections shift? And finally, it's for your branded DTC campaign. What's the ROI you're targeting? And also, like, what's the spend associated with this campaign for this year? Thanks.
Akash Tewari: Good morning. This is Ivy on behalf of Akash.
Akash Tewari: We have a couple of quick ones on Sephora. So, first, on safety. What's your current hypothesis on the causes behind the cases? Have you done any testing on PAG antibodies?
Adam J. Townsend: Add ons et cetera, et cetera, our market leadership is driven by our strong efficacy while documented safety flexible dosing and the unmatched data set that.
Adam J. Townsend: <unk> holds all of that up so that's I think incredibly important for the rest of the year and I think people choose Gi drugs for their incredibly strong efficacy.
Speaker Change: As the DTC. So our DTC campaign is actually live now on television so a new campaign for streaming.
Speaker Change: We're investing in this campaign because we think it has an incredibly strong positive return on investment it will drive more patients into retina specialists' offices, and those patients will see our ads and off the slide five range and then the four pillars of what we think builds up a great ta drug come into play that where the physician.
Speaker Change: We'll have that conversation with those patients and hopefully put those patients on so as Patrick said this is a large market and all of our DTC activities will push more patients into the market.
Speaker Change: Thanks.
Cedric Francois: Thank you so much. It's wonderful to hear from you.
Cedric Francois: So, first of all, on the hypothesis, again, as we've discussed before, it is pretty remarkable that there is this first injection phenomenon, right, from an immunological perspective. Our leading hypothesis, as you correctly mentioned, is indeed around polyethylene glycol. That is work that we will continue to do to further explore. Now, for our competitor, we will see, you know, where things land. I think what is really important for us is that the rate of vasculitis is extremely low and stays extremely low. This is a first injection phenomenon.
Speaker Change: Thank you one moment for our next question.
Cedric Francois: And the efficacy is something that, of course, really stands out for SIFO-V versus our competitor, which, at the end of the day, we think will be the most important. All of this stands in the background, of course, of this enormous market that geographic atrophy represents because of the enormous number of patients that are, unfortunately, affected by this disease. So, as it relates to the DTC campaign, I'll hand it over to Adam.
Speaker Change: Our next question comes from.
Adam J. Townsend: Yeah, Ivy, and I'll just add to what Cedric said, right? Our market leadership is driven by our strong efficacy, well-documented safety, flexible dosing, and the unmatched data set that holds all of that up. So that's, I think, incredibly important for the rest of the year, and I think people choose GA drugs for their incredibly strong efficacy. As for DTC, our DTC campaign is actually live now on TV, so our new campaigns are streaming.
Speaker Change: Ellie Merle with UBS. Your line is now open.
Eliana Rachel Merle: Oh, Hey, guys. Thanks for taking the question.
Eliana Rachel Merle: Just one quickly.
Eliana Rachel Merle: <unk> expenses and profitability just given you expect expenses to be long and 24 versus <unk> 23, and with FIFO break Raleigh. How are you thinking about when you might reach profitability and what are the potential swing factors there.
Eliana Rachel Merle: And then just a second one on your pricing strategy with what are your expectations for gross profit.
Eliana Rachel Merle: Quarter, and do you expect any uptake in creston that RBR use of sampling.
Eliana Rachel Merle: In the second quarter, and just walk us through how you're thinking about your pricing and contracting strategy. Thanks.
Speaker Change: Thank you and great to hear you.
Speaker Change: Sure. Thanks Ali so the good news is we're in a very strong financial position and we previously said that our task and our projected revenues.
Speaker Change: Are sufficient to fund our operations for the foreseeable future from an expense perspective on a quarterly basis. Our Q4 2023 expenses were lower than our.
Speaker Change: Lower than our Q3 2023 expenses by about 7% and then taking into account the one time charge for cold Agglutinin disease.
Speaker Change: This quarter, they would have been down a further five or so percent. So we haven't seen that decrease in operating expenses and we continue to believe that our expenses will be lower in 2024 and 2023.
Speaker Change: Top line you can see that we are also growing nicely and that combination.
Eliana Rachel Merle: Said will obviously allow us to fund our operations, but we don't actually guide on women become problems.
Speaker Change: Thank you one moment for our next question.
Speaker Change: And our next question comes from.
Speaker Change: Annabel <unk> with Stifel. Your line is now open.
Annabel: Hi, all thanks for taking my question.
Annabel: I want you to I wanted to ask about the referrals from ophthalmologist is that just started.
Annabel: Our or retinal specialist for working with their own patients and with the DTC campaign.
Annabel: When the retinal specialist and all of the number the volume of referrals that are going to be coming in.
Annabel: The referrals have just started.
Speaker Change: And then on the competitive landscape.
Speaker Change: Obviously, it's been out for a little bit now now they have a J code but.
Speaker Change: Instead of thinking about it as a competitive headwind do you actually think that having a competitor out there is creating more of a tailwind.
Speaker Change: For the whole entire space. So maybe you can speak to that and what dynamics you're seeing there.
Speaker Change: <unk>.
Speaker Change: Thank you so much I'll hand, it over to Adam yes, Thanks, Annabel so at the moment.
Adam J. Townsend: We're investing in this campaign because we think it has an incredibly strong positive return on investment. It will drive more patients into retina specialist offices, and those patients will see our ad and ask for cyphobrine. And then the four pillars of what we think builds up a great GA drug come into play there, where the physician will have that conversation with those patients and hopefully put those patients on. So, as Cedric said, this is a large market, and all of our DTC activities will push more cyphobrine patients.
Adam J. Townsend: Firewalls are quite lower.
Adam J. Townsend: You said right. This is a very large market so.
Adam J. Townsend: The vast majority of retina physicians treating patients that they already had a relationship with or on the books. So to speak and we believe the DTC campaign will start to push those patients that they don't have and those referrals from ophthalmologists and optometrists in to get treatment. So that's the core aspects about DTC.
Adam J. Townsend: The feedback we hear from retinal physicians is that they have the capability of accepting many many more patients.
Adam J. Townsend: And I don't think it's remotely a problem for them to treat those new additional patients and thats been consistent feedback we've got as we progress through the launch.
Adam J. Townsend: Now competition is healthy and competition does grow an incredibly large market and I think the team that we have in the field is laser focused on executing because we believe that we have the strongest product profile out that in this large and growing market. So I do think market growth driven by competition.
Adam J. Townsend: <unk> is a great tailwind for us and I think we are primed and have the best drug to be able to capitalize upon.
Speaker Change: Great. Thanks.
Operator: Thank you. One moment for our next question. From Ellie Merle with EBS, your line is now open.
Speaker Change: Thank you one moment for our next question.
Adam J. Townsend: Our next question comes from Francois <unk> with Oppenheimer. Your line is now open.
Francois: Alright, thanks for the question.
Francois: Quickly to here. So in terms of the 2000 sites that you are now and do you discuss.
Francois: You discussed some that are on the ice survey some that are only step over it but can you discuss how many sites you ultimately like to get into what's your market penetration in terms of sites that makes sense. Thank you.
Speaker Change: Thank you Eddie Thanks for that as well so yes, we're in over 2000 sites that have chosen to use <unk> and as I said before some of those sites are very slight overly dominant.
Speaker Change: We believe that there are over 3000 sites initially that we wanted to target. So we still have an opportunity for growth when it comes to sites and as I said in my very nosy metric of more than double digit new accounts using <unk> for the first time every week since launch continues so that shows you that we're making impact.
Speaker Change: The big market with a large prescriber base.
Speaker Change: Thank you and then just just quickly in terms of the readout here mid year Valeant readout.
Speaker Change: Can you just help remind us what would you consider a successful readout here.
Speaker Change: Thank you so much for the question as well we are very excited about the Valeant readout. We did that in <unk>. There is a very high unmet medical need that will be associated with an important new markets for <unk>.
Speaker Change: In the Valeant trial, we haven't ruled to 124 subjects.
Speaker Change: A very large trial across both the icmp, Jen and CPG pre transplant as well as supposed to transplant and the primary endpoint is a <unk>.
Speaker Change: Transformation in proteinuria reduction.
Speaker Change: Powered to show approximately 30%.
Speaker Change: A significant reduction.
Speaker Change: Reduction in Proteinuria is what we are looking for and will be placed in the context with some of the secondary endpoint.
Speaker Change: Thank you.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from.
Eliana Rachel Merle: Hey, guys, thanks for taking the question. Just one quickly on expenses and profitability, just giving you an expectation that expenses will be less in 24 versus 23. And with the SIFO break growing, how are you thinking about when you might reach profitability? And what are the potential swing factors there? And then just a second one on your pricing strategy is, what are your expectations for growth to net in the second quarter? And do you expect any uptick in growth to net or in your use of sampling? In the second quarter, and just walk us through how you're thinking about your pricing and contracting strategy. Thanks.
Speaker Change: Adam Vogel with Wells Fargo. Your line is now open.
Adam Vogel: Great. Thank you for taking my call them on for Derik today.
Adam Vogel: Maybe just a little bit more on the <unk> readout, how granular will you report this data out across each indication in setting and then within those or is there like one that's clearly the largest opportunity for you or are they fairly similar across indications and settings.
Speaker Change: Thank you so much Adam so.
Speaker Change: This is.
Adam: Again, a very large market opportunity and something that we're really looking forward to reading out.
Speaker Change: I didn't exactly hear your question because it was breaking up a little could you repeat that please.
Speaker Change: Alright, yes, so just.
Speaker Change: Indications hard granular are you going to be reporting Alex like each indication.
Speaker Change: Cross like pre and post kidney transplant and is there a market opportunity among these.
Speaker Change: Kind of like the largest opportunity for you guys or is it fairly similar across each indication in setting.
Speaker Change: Yes. Thank you so much so the CPG is the larger markets.
Speaker Change: The larger opportunity in terms of patients compared to ACM PGN.
Speaker Change: But I think it's important to point out as well.
Speaker Change: Correctly defense differentiating between those two indications is also not straightforward you have to look at <unk> and.
Speaker Change: And makes a determination there I think for US. The purpose was to really go very broad again, not just between the two indications, but also in the pre and post transplant setting and especially in the post transplant setting. We think we have a really unique opportunity to stand up.
Speaker Change: As the best in class opportunity.
Speaker Change #104: Got you and then maybe just one follow up.
Speaker Change #101: S J.
Speaker Change #103: Loan repayment is there any new color you can provide us on loan repayments strategies.
Timothy E. Sullivan: Sure. Thanks, Ellie.
Timothy E. Sullivan: Thank you, Ellie. Great to hear from you, Tim. Sure. Thanks, Ellie. So the good news is we're in a very
Speaker Change #100: Thank you sure. Thank you I am so.
Timothy E. Sullivan: So the good news is we're in a very strong financial position, and we've previously said that our cash and our projected revenues are sufficient to fund our operations for the foreseeable future. From an expense perspective, on a quarterly basis, our Q4 2023 expenses were lower than our Q3 2023 expenses by about 7%, and then taking into account the one-time charge for the total gluten and disease. This quarter, they would have been down another 5 or so percent.
Timothy E. Sullivan: So we have seen that decrease in operating expenses, and we continue to believe that our expenses will be lower in 2024 than in 2026. On the top line, you can see that we're also growing nicely. And that combination, we've said, will obviously allow us to fund our operations, but we don't actually guide on when we will.
Speaker Change: Look.
S J: One of the things we looked at carefully is our cash management. So ultimately when you win.
Speaker Change: If you looked at our ssj payments they amount to approximately $200 million over the next call. It 20 months and that along with our increase in receivables that we extend credit we extend to the channel.
Speaker Change: That represents a fairly large cash use for us. So obviously, we spend a good amount of time thinking about the best way.
Speaker Change: To perform balance sheet management, and we have a number of options available to us tactical options.
Speaker Change: Non dilutive options are there are several of those.
Speaker Change: So we evaluate those all the time.
Speaker Change: We'll update you if we plan to do anything there.
Speaker Change #102: Great. Thank you.
Operator: Thank you. One moment for our next question, and the next question comes from Annabel Samimy, with Stiefel. Your line is now open.
Speaker Change #106: Thank you one moment for our next question.
Annabel Eva Samimy: Hi, all. Thanks for taking my question. I wanted to ask about referrals from ophthalmologists. Has that just started, or are retinal specialists working with their own patients? And with this DTC campaign, can the retinal specialist handle the number of, the volume of referrals that are going to be coming in if the referrals have just started? And then on the competitive landscape, obviously, Isoray has been out for a little bit now
Speaker Change #106: Our next question comes from Joseph Stringer with Needham <unk> Company. Your line is now.
Joseph Stringer: Hi, Thanks for taking our question just a follow up on a prior question on the switching between <unk> and either way I understand you haven't provided quantitative metrics on this but maybe I'll ask a different way could you give us any color into perhaps the most common reasons why patients would switch between the two.
Joseph Stringer: Drugs.
Annabel Eva Samimy: Now, they have a J code, but I mean, instead of thinking about it as a competitive headwind, you actually think that having a competitor out there is creating more of a tailwind for the whole entire space. And maybe you can speak to that and what dynamics you're seeing there. Thanks.
Speaker Change #108: Thank you so much for the question.
Joseph Stringer: So look I think switchers quite frankly is not something thats.
Speaker Change #111: I think as an easy conversation between physicians ambitions. When you are on <unk>.
Joseph Stringer: Either of the two drugs do you want to switch their patients over youre going to have to go have a conversation around that.
Joseph Stringer: Again, we are mostly focused on the new patients and as they come onboard and as we've mentioned we have of course, our differentiated efficacy profiles from.
Cedric Francois: Thank you so much, Annabel. I'm going to hand it over to Adam. Yeah, thanks, Annabel.
Joseph Stringer: And again, it's an enormous market and the enormous number of patients who are in dire need.
Speaker Change #112: Adam Carolyn do you want to add something.
Adam J. Townsend: I think it's uncommon for physicians switching now the majority of physicians are really very happy with our transparency with our messaging and with our efficacy.
Speaker Change #109: And in the long term.
Speaker Change #109: This is an elderly patient population.
Adam J. Townsend: You want to have this true every other month dosing, which shows enormous efficacy into year, three and beyond and I think that really speaks to the doctors and they sort of understand the safety messaging.
Adam J. Townsend: Which has also been associated with <unk> injections as a whole understand that are able to confirm that patients and we've moved on from that and.
Adam J. Townsend: And Joe just to add it's Adam Yeah. So I think the switching dynamic did occur.
Adam: During the summer months of last year, we have also seen some patients anecdotally switched back to <unk>.
Speaker Change #121: As Caroline says our assumption there is that this is F C driven market.
Adam: These are incredibly well educated patients and physicians.
Speaker Change #117: We continue to see the strong majority of new stop start on slide five and I think thats, a very positive indicator.
Speaker Change #113: Great. Thank you so much for taking my question.
Adam J. Townsend: Yeah, thanks Annabel. So at the moment, referrals are quite low. And as you said, this is a very large market. So the vast majority of retina physicians are treating patients that they already have a relationship with or who are on their books, so to speak. And we believe the DTC campaign will start to push those patients that they don't have and those referrals from ophthalmologists and optometrists into getting treatment. So that's the core aspect of our DTC. The feedback we hear from retinal physicians is that they have the capability of accepting many, many more patients, and I don't think it's remotely a problem for them to treat those new additional patients.
Speaker Change #114: Thank you.
Speaker Change #116: Thank you one moment for our next question.
Speaker Change #115: Our next question.
Adam J. Townsend: And that's been consistent feedback we've got as we progress through the law. Now, competition is healthy, and competition does grow an incredibly large market. And I think the team that we have in the field will lay the focus on executing because we believe that we have the strongest product profile out there in this large and growing market. So I do think market growth driven by competition is a great tailwind for us. And I think we're primed and have the best drive to be able to capitalize on it.
Speaker Change #115: It comes from Douglas Tsao with H C. Wainwright. Your line is now open.
Operator: Thank you. One moment for our next question. Our next question comes from Francois Brisebois with Oppenheimer. Your line is now open.
Douglas Dylan Tsao: Hi, good morning, Thanks for taking my questions and congrats on the progress just you've noted.
Douglas Dylan Tsao: But this does escalate it seems to be a first.
Douglas Dylan Tsao: Section phenomenon I'm, just curious is there anything that you can do to lower the rate from the one and 4000, which is already rare but.
Douglas Dylan Tsao: To minimize it even further.
Douglas Dylan Tsao: And I guess I'd just be curious if their efforts both in the near term or perhaps longer term work that could be done. Thank you.
Francois Brisebois: Thank you for that, Adam. Thanks, Francois. So, yes, we're among over 2000 sites that have chosen to use cyfovery.
Adam J. Townsend: Thanks Francois. So yes, we're on over 2000 sites that have chosen to use Siphovery. And as I said before, some of those sites are very Siphovery dominant. We believe that there are over 3000 sites initially that we want to target. So we still have an opportunity for growth when it comes to sites. And, as I said, my very nerdy metric of more than double-digit new accounts using Siphovery for the first time every week since launch continues to be accurate. So that shows you that we're making an It's a big market with a large prescriber base. Thank you.
Speaker Change #119: Thank you so much.
Speaker Change #119: Looking into ways to potentially predict.
Speaker Change #119: At risk patients that are there.
Speaker Change #119: Again kind of placing things into context here right I mean, the rate that we have here is similar to what you have with.
Speaker Change #119: For an infectious endophthalmitis, which is a risk that happens in every single injection that is though right. So most importantly last year. When we went into this the question was is this a problem that is just the beginning of much more and it is not so right now we are in a period of stabilization.
Adam J. Townsend: Thank you so much for that question as well. We are very excited about the Valiant readout. We believe that in C3G and ICMP-Gen, there is a very high and unmet medical need that will be associated with an important new market for Empavedi. In the Valiant trial, we have enrolled 124 subjects. You know, a very large trial across both ICMP-Gen and C3G pre-transplant as well as post-transplant, and the primary endpoint is a logarithmic transformation in proteinuria reduction powered to show approximately 30%, but a, you know, significant reduction in proteinuria is what we are looking for and will be placed in the context of some of the secondary endpoints.
Douglas Dylan Tsao: To understand the risks we've been incredibly I think good and transparent communicating it and now the dialogue is shifting towards efficacy.
Douglas Dylan Tsao: And I'm just curious as a follow up to the extent that there are practices using both sides.
Speaker Change #118: Well as either vet.
Speaker Change #118: You get a sense of whether the physician.
Speaker Change #118: Sort of how how is ultimately.
Speaker Change #118: Sided which drug a patient will get is it being left up to the patient do you get the sense or is it sort of or physicians choosing patients by any number of different reasons.
Speaker Change #126: Thank you Caroline.
Speaker Change #120: Well I think some of these practices are so large.
Speaker Change #120: There is a benefit to offering across all of its therapeutic option. For example, a patient might come in who was treated in a different state and wants to continue on and while they're vacationing with their treatment and then they'll go back to there's a whole host of reasons that speak to physician choices, but I think the main.
Speaker Change #120: Seeing that physicians like is efficacy and that is really where we're strong.
Speaker Change #120: Efficacy and flexibility, while being transparent with our safety dosing.
Speaker Change #128: I can only say that in my practice we offer.
Speaker Change #120: Every therapeutic option that's available but the discussion is often based on statistics with the patients and making that choice with them together.
Speaker Change #122: Great. That's helpful. Thank you.
Operator: Thank you. One moment for our next question. Adam Vogel with Wells Fargo, your line is now open.
Speaker Change #124: Thank you one moment for our next question.
Speaker Change #124: Yes.
Adam Vogel: Great, thank you for taking my call. I'm on behalf of Derek today.
Speaker Change #124: And our next question comes from Greg <unk> with Mizuho Securities. Your line is now open.
Greg: Great. Thanks, so much for taking my questions and congrats on the nice safe ovary number.
Greg: I was wondering if you could either qualify or quantify what you're expecting.
Greg: The recent implemented implementation of the CMS J code for ice survey to have or has it already had if there has been any.
Speaker Change #125: And maybe a second question is a follow up.
Greg: I believe a question was asked earlier about expectations around gross to net what we could expect them for perhaps the second quarter and how that might evolve throughout the year. Thanks.
Adam Vogel: Maybe just a little bit more on the valiance readout. How granular will you report this data out across each indication and setting? And then within those, is there one that's clearly the largest opportunity for you? Or are they fairly similar across indications and settings?
Speaker Change #127: Thank you Rick Adam on CMS, and then Tim.
Cedric Francois: Thank you so much, Adam. So, you know, this is, you know, again, a very large market opportunity and something that we're really looking forward to reading out. I didn't exactly hear the question because it was breaking up a little bit. Could you repeat that, please?
Timothy E. Sullivan: Yes, So I think J code unlocks prescribers and so just like it was for US I think the J code will unlock some prescribers for either way.
Adam Vogel: Sorry, yes, so just across indications, how granular are you going to be reporting out each indication across like pre and post kidney transplants, and is there a market opportunity among these that is kind of like the largest opportunity for you guys, or is it fairly similar across each indication and setting? Yeah, thank you.
Cedric Francois: Yeah, thank you so much. So, C3G is the larger market or the larger opportunity in terms of patients compared to ICMPGN. But I think it's important here to point out as well that correctly differentiating between those two indications is also not straightforward. You have to look at the histopathology and make the determination there. I think for us, the purpose was to really go very broad, again, not just between the two indications but also in the pre- and the post-transplant setting. And especially in the post-transplant setting, we think we have a really unique opportunity to stand out as a best-in-class opportunity.
Timothy E. Sullivan: But just as a reminder, right being the number one chosen ziyang therapy across new starts and continuing patients. So I think that we win when those conversations take place based on the strong efficacy in the well documented safety so.
Greg: <unk> J code has an impact just like it did for us.
Greg: Laser focus on executing our plan in this massive market and I'm going to hand to Tim on gross to net.
Operator: Thank you. One moment for our next question. Our next question comes from Joseph Stringer with Needham & Company. Your line is now open.
Adam Vogel: Got you. And then maybe just one follow-up. On the SFJ Loan repayment. Is there any new color you can provide us on the loan repayment strategy? Thank you, Tim.
Joseph Stringer: Thank you so much for the question. So, look, I think switchers, quite frankly, is not something that I think is an easy conversation between physicians and patients. When you are on either of the two drugs, you know, and you want to switch that patient over, you're going to have to have a conversation around that. You know, again, we are mostly focused on new patients, and as they come on board, and as we've mentioned, we have, of course, our differentiated efficacy profiles to work from. And again, it's an enormous market and an enormous number of patients who are in dire need.
Timothy E. Sullivan: Thank you, Tim. Sure. Thank you, Adam.
Cedric Francois: Adam, Caroline, do you want to add something?
Timothy E. Sullivan: Thank you for the question Greg, Yes, so for gross to net it has been relatively stable.
Timothy E. Sullivan: You know, look, one of the things we look at carefully is our cash management. So ultimately, when you when you. You look at our SFJ payments; they amount to approximately $200 million over the next, call it 20 months, and that, along with our increase in the receivables that we extend, so the credit we extend to the channel, that represents a fairly large cash use for us. So, obviously, we spend a good amount of time thinking about the best way to perform balance sheet management, and we have a number of options available to us. Tactical options, non-dilutive options are, you know, there's several of those, so, you know, we evaluate those all the time. We'll update you if we plan to do anything there.
Caroline R. Baumal: I think it's uncommon for physicians to be switching now. The majority of physicians are really very happy with our transparency, with our messaging, and with our efficacy. And in the long term, and this is an elderly patient population, they want to have this true every other month dosing, which shows enormous efficacy for us into year three and beyond. And I think that really speaks to doctors, and they sort of understand the safety messaging which has also been associated with intravitreal injections as a whole, understand that, are able to inform their patients, and have moved on from that. And, Joey, just to add to this, Adam, yeah, so I think the switching is
Adam J. Townsend: And Joey, just to add, it's Adam. Yeah, so I think the switching dynamic did occur during the late summer months of last year. We have also seen some patients anecdotally switch back to cyphoboreum. As Caroline says, our assumption there is that this is an efficacy-driven market, and these are incredibly well-educated patients and physicians. We continue to see the strong majority of new starts start on cyphoboreum, and I think that's a very positive thing.
Timothy E. Sullivan: And really we don't comment generally other than to say, we've had a pretty wide range of 10% to 20% that we've said.
Timothy E. Sullivan: I think it's it's a wide range, but you can get somewhere in the middle and understand where we're at.
Timothy E. Sullivan: And that has been consistent.
Speaker Change #131: Thank you.
Speaker Change #131: I'm showing no further questions at this time I would now like to turn it back to Cedric Francois for closing remarks.
Operator: Thank you. One moment for our next question. Our next question comes from Douglas Tsao with HC Wainwright. Your line is now open.
Douglas Dylan Tsao: Hi, good morning, and thanks for taking the questions and congrats on the progress. Just, you know, you've noted that this vasculitis seems to be a first injection phenomenon. I'm just curious, is there anything that you can do to lower the rate from the 1 in 4,000, which is already rare, but to minimize it even further? And I guess I'd just be curious if there are efforts, you know, both in the near term or perhaps longer term work that could be done. Thank you.
Cedric Francois: Thank you so much, Doug. Look, we are looking into ways to potentially predict the at-risk patients that are there. But again, kind of placing things into context here, right? I mean, the rate that we have here is similar to what you have for infectious endophthalmitis, which is a risk that happens at every single injection that is done, right? So, most importantly, last year when we went into this, the question was, is this a problem that is just the beginning of, you know, much more?
Cedric Francois: And it is not. So, right now, we are in a period of stabilization. Physicians understand the risk. We've been, you know, incredibly, I think, good and transparent at communicating it. And now the dialogue is shifting toward efficacy.
Cedric Francois: Thank you so much everyone for joining if you have any follow up questions. Please feel free to reach out to Meredith and we look forward to hearing and speaking with many of you today and in the next week. Thank you.
Douglas Dylan Tsao: And I'm just curious as a follow-up, you know, to the extent that there are practices using both Cyfovir as well as Isorve, do you get a sense whether the physician ultimately decides which Gerardier patient will get? Is it being left up to the patient, do you get the sense, or is it sort of physicians choosing patients by any number of different reasons?
Caroline R. Baumal: Yeah, thank you. Caroline, do you want to? Well, I do.
Caroline R. Baumal: Well, I think some of these practices are so large, they, you know, there's a benefit to offering all the therapeutic options. For example, a patient might come in who was treated in a different state and wants to continue on while they're vacationing with their treatment, and then they'll go back. So there's a whole host of reasons that speak to physician choices: transparency, efficacy, and flexibility while being transparent with our Safety Dose. So I can only say that in my practice, we offer. Thank you.
Douglas Dylan Tsao: Great, that's helpful. Thank you. Thank you.
Operator: Thank you. One moment for our next question, and our next question comes from Graig Suvannavejh with Mizuho Securities. Your line is now open.
Graig C. Suvannavejh: Great, thanks so much for taking my questions, and congrats on the nice SIFO re-number. I was wondering if you could either qualify or quantify what you're expecting the recent implementation of the CMSJ code for iSurvey to have, or has it already had, if there have been any, and maybe a second question as a follow-up.
Cedric Francois: Thank you, Greg. Adam on CMS and then Tim on RISD.
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Adam J. Townsend: Yeah, so I think J-Code unlocks prescribers, and so I, you know, just like it was for us, I think the J-Code will unlock some prescribers for Isovay. But just as a reminder, right, being the number one chosen GA therapy across new starts and continuing patients, I think that we win when those conversations take place based on strong efficacy and well-documented safety. So J-Code has an impact just like it did for us, but we're laser focused on executing our plan in this massive market, and I'm going to hand it to Tim on GrossNet. Thank you for the question, Greg. Yeah, so for growth.
Timothy E. Sullivan: Thank you for the question, Greg. Yeah, so for gross net, no, it has been relatively stable. And really, we don't comment generally other than to say we've had a pretty wide range of 10 to 20% that we've said. You know, I think it's a wide range, but you can get somewhere in the middle.
Operator: I'm showing no further questions at this time. I would now like to turn it back to Cedric Francois for closing remarks.
Speaker Change #129: Thank you for participating you may now disconnect.
Cedric Francois: Thank you so much, everyone, for joining us. If you have any follow-up questions, please feel free to reach out to Meredith, and we look forward to hearing from and speaking with many of you today and the next week.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
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