Q2 2024 Apellis Pharmaceuticals Inc Earnings Call
Apyllis Pharmaceutical's: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to Apellis Pharmaceuticals' second quarter 2024 earnings conference call.
Operator: and 24-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 this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again.
Speaker Change: 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 this session, you will need to press star 11 on your telephone. You will then hear an automated message advising you your hand is raised.
Operator: Please be advised that today's conference is being recorded.
Meredith Kaya: I would now like to hand the conference over to Meredith Kaya, Senior Vice President, Investor Relations, and Strategic Finance. Please go ahead.
Meredith Kaya: To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Meredith Kaya, Senior Vice President, Investor Relations and Strategic Finance. Please go ahead.
Meredith Kaya: I would now like to hand the conference over to Meredith Kaya, Senior Vice President, Investor Relations and Strategic Finance. Please go ahead.
Cedric Francois: Good morning and thank you for joining us to discuss Apellis' second quarter, 2024 financial results. With me on the call, our 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. Before we begin, let me point out that we will be making forward-looking statements.
Meredith Kaya: Good morning, and thank you for joining us to discuss Apellis's second 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. 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: Good morning, and thank you for joining us to discuss Apellis' second quarter 2024 financial results.
Speaker Change: 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.
Speaker Change: Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs.
Speaker Change: 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.
Cedric Francois: Thank you, Meredith, and thank you all for joining us this morning. We are in a unique position today with one and the potential for two blockbuster drugs in the market. One and a half million highly motivated patients and a long runway for continued growth. That said, there has been a lot of focus on near-term dynamics. Our competitor has recently had still wins driven by factors such as its new J-code. They had every incentive to drive the amount a new patient starts as much as possible, and yet we saw approximately health of new patients choose Cypheri.
Cedric Francois: Thank you, Meredith, and thank you all for joining us this morning. We are in a unique position today with one, and the potential for two, blockbuster drugs in the market, Cyfovir and Empavedin, both of which are making a meaningful difference for patients. The past six months have been a period of continued progress and execution by the Apellis team, but we recognize that there are questions around the competitive landscape for Sifo-Ri. Given this, I wanted to share some of my thoughts.
Cedric Francois: Thank you, Meredith, and thank you all for joining us this morning.
Cedric Francois: We are in a unique position today with one and the potential for two blockbuster drugs in the market, cyfovir and empavirine, both of which are making a meaningful difference for patients.
Speaker Change: The past six months have been a period of continued progress and execution by the Apellis team, but we recognize that there are questions around the competitive landscape for SIFO-RE.
Cedric Francois: Saifover is the market leader in a category with only two available drugs. Importantly, the recent SRS meeting was a strategic turning point for us, where our focus and our discussions shifted to CyphoV's strong and differentiated efficacy profile. During the podium presentation at ASRS, the REST Committee confirmed this estimated rate and agreed that it appears to be only on the first index, the Best Available Functional Measure of GA. We look forward to sharing our progress at an upcoming Investor Day towards the end of this year.
Speaker Change: Given this, I wanted to share some of my thoughts.
Speaker Change: SysOvri is the market leader in a category with only two available drugs.
Speaker Change: One and a half million highly motivated patients and a long runway for continued growth.
Speaker Change: That said, there has been a lot of focus on near-term dynamics. Our competitor has recently had tailwinds driven by factors such as its new J code.
Speaker Change: They had every incentive to drive demand in new patient starts as much as possible, and yet we saw approximately half of new patients choose Cyfovirine.
Cedric Francois: Following last month's successful SRS meeting, we believe Cypheri's clinical profile is being viewed favorably by physicians and will drive more growth in new patient starts over time. The Cypheri launch has been one of the best launches in recent history, generating over a half a billion dollars in sales in its first six quarters and achieving double-digit percentage growth every single quarter. More than 330,000 Cypheri injections are estimated to have been administered to patients, and this strong growth is continuing into the second half of the year. The GA market is growing significantly, and Cypheri has only scratched the surface of its long-term potential.
Speaker Change: Following last month's successful ASRS meeting, we believe Stiprobrex clinical profile is being viewed favorably by physicians and will drive more growth in new patient starts over time.
Speaker Change: The SIFOVI launch has been one of the best launches in recent history, generating over half a billion dollars in sales in its first six quarters and achieving double-digit percentage growth every single quarter.
Speaker Change: More than 330,000 cyfovir injections are estimated to have been administered to patients, and this strong growth is continuing into the second half of the year.
Speaker Change: The GA market is growing significantly, and cyphoria has only scratched the surface of its long-term potential.
Cedric Francois: Importantly, the recent SRS meeting was a strategic turning point for us, where our focus and our discussions shifted to Cypheri's strong and differentiated efficacy profile. We have multiple analyses supporting the efficacy of Cypheri, and retina doctors are enthusiastic about the totality of these data. The favourable benefit-risk profile of Cypheri is becoming clearer to physicians, with some key takeaways. One, both monthly and every other month's Cypheri treatment showed a better efficacy profile than the competitor among patients with non-symptomatic GA at both 12 and 24 months as detailed in the matching adjusted indirect comparison, both stock analysis presented.
Speaker Change: Importantly, the recent SRS meeting was a strategic turning point for us where our focus and our discussions shifted to CyfoV's strong and differentiated efficacy profile.
Speaker Change: We have multiple analyses supporting the efficacy of cyfovir, and retina doctors are enthusiastic about the totality of these data.
Speaker Change: The favorable benefit-risk profile of cyfovirine is becoming clearer to physicians with some key takeaways.
Cedric Francois: Note that no head-to-head clinical trials have been performed. Two, Cypheri is clinically proven to offer flexible dosing from day one. Every other month's treatment with Cypheri provides an even safer and more cost-effective treatment while maintaining its strong efficacy. And three, regarding safety, vasculitis is rare and appears to be a first injection phenomenon. The estimated rate has remained stable at 1 in 4,000 per first injection. During the podium presentation at SRS, the rest committee confirms this estimated rate has agreed that it appears to be only on the first injection.
Speaker Change: Note that no head-to-head clinical trials have been performed.
Speaker Change: Two, Cyfovery is clinically proven to offer flexible dosing from day one.
Speaker Change: Every other month treatment with Cyfobrine provides an even safer and more cost-effective treatment while maintaining its strong efficacy.
Speaker Change: And three, regarding safety, vasculitis is rare and appears to be a first-injection phenomenon. The estimated rate has remained stable at 1 in 4,000 per first injection.
Speaker Change: During the polling presentation at ASRS, the REST committee confirmed this estimated rate and agreed that it appears to be only on the first injection.
Cedric Francois: After this meeting, we continue to believe that we are well-positioned to continue growth and further cement our market leadership in GA for many years to come. Our singular focus is to ensure that every GA patient who needs treatment has access to Cypheri. This is how we expect Cypheri to continue on its path of becoming a multi-billion-dollar drug.
Cedric Francois: As for the European GA opportunity, we are focused on the CHMP re-examination process and are encouraged by the progress we made throughout the initial review. This was not an unexpected outcome, given that the process was reset back to day 180 of the initial review and therefore led by the original rapporteurs. We were encouraged to learn that, in this recent opinion, multiple CHMP members disagreed with a negative opinion. Additionally, the external advisory experts were aligned on microprimetry as the best available functional measure of GA. We are humbled by the broad support shown by the European retina community, and while we remain conservative in our expectations for the re-examination, we believe we are well-positioned heading into the appeal.
Speaker Change: This is how we expect CyproV to continue on its path of becoming a multi-billion dollar drug.
Speaker Change: As for the European GA opportunity, we are focused on the CHMP reexamination process and are encouraged by the progress we made throughout the initial review.
Speaker Change: This was not an unexpected outcome given that the process was reset back to day 180 of the initial review and therefore led by the original rapporteurs.
Speaker Change: Additionally, the external advisory experts were aligned on microperimetry as the best available functional measure of GA.
Speaker Change: We are humbled by the broad support shown by the European Retina Community, and while we remain conservative in our expectations for the re-examination, we believe we are well positioned heading into the appeal.
Cedric Francois: To a new rapporteurs who are recently designated, and we continue to expect the final decision to be issued in the fourth quarter of 2024.
Cedric Francois: Moving to empathy, which continues to elevate the standard of care for patients with DNH. Empathy generated $24.5 million in product sales in the second quarter. We continue to believe that patients on Empathy are experiencing substantial benefits, as demonstrated by a 97% compliance rate. Importantly, we are exploring its potential to expand into new indications and become a best-in-class treatment option for additional high and med-need areas. The upcoming 5th 3-valon stopline readout in C3G and primary ICMPGN is the next milestone in this process. And we expect to present these data later this month. With the data are positive, we plan to submit a supplemental NDA to the FDA for approval.
Speaker Change: Moving to Empathetic, which continues to elevate the standard of care for patients with PNH.
Speaker Change: Empavedi generated $24.5 million in product sales in the second quarter.
Speaker Change: We continue to believe that patients on EmpaPedi are experiencing substantial benefits, as demonstrated by its 97% compliance rate.
Speaker Change: Importantly, we are exploring its potential to expand into new indications and become a best-in-class treatment option for additional high and med-need areas.
Speaker Change: The upcoming Phase III valiance top-line readout in C3G and primary ICMP-GN is the next milestone in this process.
Speaker Change: And we expect to present these data later this month.
Speaker Change: If the data are positive, we plan to submit a supplemental NDA to the FDA for approval.
Cedric Francois: Regarding the pipeline, we are advancing multiple earlier stage development programs, leveraging our core expertise in consulment science to fuel the next phase of value creation for attendees.
Cedric Francois: We look forward to sharing our progress and an upcoming investor day to work towards the end of this year. And finally, from a financial perspective, we are benefiting from the growing product revenue generated by Cyphery and Ambavedi and has actively taken steps to strengthen our balance sheet. We now have a clear line of sites to positive cash flow, allowing us to invest in future growth without having to rely on the capital markets.
Speaker Change: We look forward to sharing our progress at an upcoming Investor Day towards the end of this year.
Cedric Francois: And finally, from a financial perspective, we are benefiting from the growing product revenue generated by Saifovri and Empavedi and have actively taken steps to strengthen our balance sheet. And to our shareholders, many of whom have stood with us through these dynamic periods and provided unwavering support to us over the years. Sales growth remains strong at more than 12% quarter over quarter.
Speaker Change: And finally, from a financial perspective, we are benefiting from the growing product revenue generated by Saifovri and Empavedi and have actively taken steps to strengthen our balance sheet.
Speaker Change: We now have a clear line of sight to positive cash flow, allowing us to invest in future growth without having to rely on the capital markets.
Cedric Francois: Before I turn it over to Adam to discuss our commercial activities, I will close by saying thank you to the patients and physicians who motivate us to develop and bring important treatments to market, and to the Appedi's team who have shown unbelievable commitments and perseverance in getting these important medicines to patients. And to our shareholders, many of whom have stood with us through these dynamic periods and provided amazing support to us over the years.
Speaker Change: Before I turn it over to Adam to discuss our commercial activities, I will close by saying thank you to the patients and physicians who motivate us to develop and bring important treatments to market.
Speaker Change: And to our shareholders, many of whom have stood with us through these dynamic periods and provided unwavering support to us over the years.
Adam Townsend: With that, I will now turn it over to Adam.
Adam Townsend: Thanks, Cedric, and good morning, everyone. I will begin with Cyphery with revenue of about $155 million. Dale's growth remains strong at more than 12% quarter over quarter. In the second year of a product launch, quarterly growth rates at these levels are a strong indicator of longer-term demand. We deliver over 79,000 commercial doses and approximately 5,000 samples of Cyphery in the second quarter. Demand continue to accelerate, with June being our highest demand month since launch through the second quarter. We are particularly pleased to see the continued progress across the many factors driving growth, including new patient demand and a broadening prescriber base.
Adam Townsend: I will begin with SIFOBRI. With revenue of about $155 million, sales growth remains strong at more than 12% quarter over quarter.
Adam Townsend: In the second year of a product's launch, quarterly growth rates at these levels are a strong indicator of longer-term demand.
Speaker Change: We delivered over 79,000 commercial doses and approximately 5,000 samples of syphovir in the second quarter.
Cedric Francois: Demand continues to accelerate, with June being our highest demand month since launch through the second quarter. In addition, only a small portion of newly diagnosed and treated patients are referrals. This suggests that the majority of GA patients have not yet been diagnosed or referred to retina specialists.
Speaker Change: Demand continued to accelerate, with June being our highest demand month since launch through the second quarter.
Speaker Change: We are particularly pleased to see the continued progress across the many factors driving growth, including new patient demand and a broadening prescriber base.
Adam Townsend: Cedric mentioned some of the competitive dynamics, which I know is on everyone's mind. So let's start there. Our competitor has recent tailwinds driven by factors such as obtaining its new J-coat. And so it is expected that they would see their proportion of new patient share accelerate. We also saw an acceleration when Cyphery's J-coat went into effect last October. However, we do not believe this is indicative of longer-term market dynamics. We have taken the long view on contracting, as we believe this is a large and growing market and believe that discounting too aggressively now is unsustainable and will lead to price degradation over time.
Speaker Change: We have taken the long view on contracting, as we believe this is a large and growing market and believe that discounting too aggressively now is unsustainable and will lead to price degradation over time.
Adam Townsend: We are also executing our strategic plan in the field to reinforce Cyphery's benefit-risk profile. Cyphery remains the number one chosen treatment for GA, with approximately 75% of the treated market as defined by the total number of... We believe Syphovery's position as the market leader will continue to be driven by its differentiated Eskasy profile and flexible dosing. Importantly, we are also focused on maintaining market leadership whilst growing the overall GA category. We are still in the beginning stages. Our estimate based on claims data is that about 13% of GA patients who have been diagnosed and are managed by an eye care professional are currently being treated.
Speaker Change: Syphogy remains the number one chosen treatment for GA, with approximately 75% of the treated market as defined by the total number of patients treated.
Speaker Change: We believe Sifo-Re's position as the market leader will continue to be driven by its differentiated efficacy profile and flexible dosing.
Speaker Change: Importantly, we are also focused on maintaining market leadership whilst growing the overall GA category.
Adam Townsend: In addition, only a small portion of newly diagnosed and treated patients are referrals, meaning that most patients currently receiving treatment were already being seen by a retinus specialist. This suggests that the majority of GA patients have not yet been diagnosed or referred to retinus specialists, really forcing that we have only scratched the surface of the large opportunity for Syphovery. As I mentioned on our last earnings call, we are now executing the next phase of our commercial and medical strategy. After the ASRS meeting in 2023, we developed a two-phase strategic plan with a two-year timeline. Phase one was focused on being transparent and educating the right of community about everything we were learning at the time around safety.
Speaker Change: In addition, only a small portion of newly diagnosed and treated patients are referrals.
Speaker Change: This suggests that the majority of GA patients have not yet been diagnosed or referred to retina specialists.
Adam Townsend: This past quarter, we shifted to phase two of the strategy, which is focused on strengthening our leadership in this growing market. More than 2,100 sites of care have ordered Syphovery. We are now on our front foot, expanding the number of new physicians using Syphovery, deepening our relationships with existing Syphovery users, establishing strong payer access and reimbursement, and increasing awareness and education for patients. With physicians, we are communicating a clean and simple efficacy message, highlighting Syphovery's increasing effects over time, which is critical given that GA is a chronic disease. We are also sharing the microperimetry data from the GAIL extension study.
Cedric Francois: This past quarter, we shifted to Phase 2 of the stretch. We will continue to execute flawlessly and be focused on getting more doctors, patients, and payers to understand the efficacy and the benefits that the leading GA drug can deliver. Scotomatous points measure the areas of the retina that have lost all light sensitivity and, therefore, are no longer functioning.
Speaker Change: This past quarter, we shifted to Phase 2 of the strategy.
Speaker Change: which is focused on strengthening our leadership in this growing market.
Speaker Change: With physicians, we are communicating a clean and simple efficacy message, highlighting SIFO release increasing effects over time, which is critical given that GA is a chronic disease.
Adam Townsend: The only data for an approved GA treatment that demonstrates a visual function benefit in a pre-specified endpoint. This allows for a productive benefit-risk discussion, with the every other month dosing option having a dramatically positive impact for patients, doctors, and payers. We had a successful ASRS meeting a few weeks ago, our first big retina meeting leading with these messages, and look forward to the upcoming four congresses. We are also continuing to broaden our reach to more retina specialists as well as other referring I can't provide us, who see tens of thousands of GA patients. Reaching these physicians and educating them on the referral process are key to developing the GA market.
Speaker Change: We are also sharing the microperimetry data from the Gale Extension Study, the only data for an approved GA treatment that demonstrates a visual function benefit in a pre-specified endpoint.
Speaker Change: This allows for a productive benefit-risk discussion, with the every-other-month dosing option having a dramatically positive impact for patients, doctors, and payers.
Speaker Change: We had a successful ASRS meeting a few weeks ago, our first big retina meeting leading with these messages.
Speaker Change: I look forward to the upcoming four Congresses.
Speaker Change: Reaching these physicians and educating them on the referral process are key to developing the GA market.
Adam Townsend: With payers, we have secured unprecedented and broad coverage for patients choosing Syphovery. We are thrilled to share that two large national pharmacy benefit managers have recently made Syphovery the only preferred treatment on their commercial formula. As the preferred product, this means that the new patients with commercial insurance will have full access to Syphoveries as the first-line treatment, and an exception process will have to be undertaken for non-preferred or disadvantaged products. While payers have several considerations in making such decisions, we believe these decisions were driven by Syphoveries' compelling value propositions. Highlighting its robust efficacy, with increasing effects over time, and both monthly and, more importantly, every other month dosing.
Speaker Change: We're thrilled to share that two large national pharmacy benefit managers have recently made syphovery the only preferred treatment on their commercial formularies.
Speaker Change: As the preferred product, this means that the new patients with commercial insurance will have full access to syphovir as the first-line treatment, and an exception process will have to be undertaken for non-preferred or disadvantaged products.
Speaker Change: While payers have several considerations in making such decisions, we believe these decisions were driven by SIFOBRI's compelling value propositions.
Speaker Change: Highlighting its robust efficacy.
Adam Townsend: These two PVM decisions are important milestones, demonstrating payers' strong relief in Syphoveries' clinical and economic value propositions, as ensuring broad coverage and seamless reimbursement is critical for the redness specialists. And with patients, we've launched the first phase of our branded DTC campaign in the spring, which is focused on encouraging patients to talk to their physicians about GA treatment with Syphoveries. We're excited to launch phase two of our branded DTC campaign, extending our relationship with the beloved Henry Winkler in the fourth quarter. This is a very large market, and we will be methodical in executing this next phase in order to set ourselves up for the long term.
Speaker Change: These two PBM decisions are important milestones demonstrating payors' strong belief in SIFOBRI's clinical and economic value proposition.
Speaker Change: as ensuring broad coverage and seamless reimbursement is critical for retina specialists.
Adam Townsend: We will continue to execute flawlessly and be focused on getting more doctors, patients, and payers to understand the efficacy and the benefits that the leading GA drug can deliver.
Speaker Change: We will continue to execute flawlessly and be focused on getting more doctors, patients and payers to understand the efficacy and the benefits that the leading GA drug can deliver.
Adam Townsend: Now, let me shift to Ampere Valley. In the second quarter, Ampere Valley generated approximately $24.5 million in U.S. net product sales. The positive trends across the key leading indicators for the PNH patient population continue into 2024. Specifically, compliance rates remain high at 97%, and we continue to have a very strong safety profile. As we previously said, with the availability of an oral treatment for PNH, we are facing a more competitive market and expect sales to be flat at least through the next six to twelve months. We continue to have new patients starting Ampere Valley treatment, but this has been offset by some patients switching to an oral.
Speaker Change: Now, let me shift to Ampervelli. In the second quarter, Ampervelli generated approximately $24.5 million in U.S. net product sales.
Speaker Change: The positive trends across the key leading indicators for the PNH patient population continue into 2024.
Adam Townsend: Finally, I will echo centric enthusiasm regarding the opportunity to potentially expand Ampere Valley into C3G and ICMPGM. This market is approximately three times larger than the PNH market, and there are no available treatments. It's Ampere Valley is approved in these indications. We are confident that we can leverage much of our existing infrastructure to rapidly reach nephrologists and deliver Ampere Valley to the thousands of patients suffering from these diseases.
Speaker Change: Finally, I will echo Cedric's enthusiasm regarding the opportunity to potentially expand Empaveli into C3G and ICM-PGM.
Speaker Change: This market is approximately three times larger than the P&H market and there are no available treatments.
Speaker Change: If Empovelli is approved in these indications, we are confident that we can leverage much of our existing infrastructure to rapidly reach nephrologists and deliver Empovelli to the thousands of patients suffering from these diseases.
Caroline Baumal: With that, I will now turn the call over to Caroline.
Caroline Baumal: Caroline? Thanks, Adam, and good morning, everyone. We are looking forward to sharing the valiant data later this month. I'll talk more about this opportunity in a minute. I will first talk about Syphovery as our team was recently at the ASRS meeting in Stockholm, where we had a significant presence with five oral presentations, including a late-breaking abstract on visual functioning from Gail. We are particularly excited by these visual function data, as this was the first time a geographic atrophy treatment had demonstrated a visual function benefit on a pre-specified analysis. Result showed that with respect to the microperimetry endpoint, patients treated with pegs at a Copeland monthly, or every other month, developed fewer new scatomative points over 36 months, compared to patients from the sham crossover group.
Speaker Change: Thanks, Adam, and good morning, everyone. We are looking forward to sharing the Valiant data later this month.
Speaker Change: I'll talk more about this opportunity in a minute.
Speaker Change: I will first talk about SIFOVRI, as our team was recently at the ASRS meeting in Stockholm, where we had a significant presence with five oral presentations, including a late-breaking abstract on visual function from Gail.
Speaker Change: We are particularly excited by these visual function data, as this was the first time a geographic atrophy treatment had demonstrated a visual function benefit on a pre-specified analysis.
Speaker Change: Results showed that with respect to the micropermetry endpoint,
Caroline Baumal: Scatomative points measure the areas of the retina that have lost all light sensitivity and therefore are no longer functioning. These results add to the largest body of evidence for a geographic atrophy treatment and reinforce the unprecedented effects shown by syphovery to both meaningfully slow geographic atrophy lesion growth and, by doing so, preserve visual function. ASRS is one of the most important retina meetings of the year, and we had the opportunity to engage with many members of the retina community. This was a highly successful meeting for syphovery, and we heard repeatedly from doctors about its differentiated benefits.
Gail: Scotomatous points measure the areas of the retina that have lost all light sensitivity and therefore are no longer functioning.
Speaker Change: These results add to the largest body of evidence for a geographic atrophy treatment.
Speaker Change: ASRS is one of the most important retina meetings of the year, and we had the opportunity to engage with many members of the retina community.
Speaker Change: This was a highly successful meeting for syphovary, and we heard repeatedly from doctors about its differentiated benefits.
Caroline Baumal: We look forward to continuing to engage with this community at upcoming meetings and to share the ongoing progress of syphovery in patients with geographic atrophy.
Speaker Change: We look forward to continuing to engage with this community at upcoming meetings and to share the ongoing progress of syphovery in patients with geographic atrophy.
Caroline Baumal: Moving to Empivelli, later this month, we expect to share top-line results from our phase three Valiant study of pegs at a Copeland and people living with C3G and ICMPGM, two rare and debilitating kidney diseases caused by uncontrolled complement activation and breakdown of C3. Patients are usually diagnosed in adolescence, and about 50% advanced to end stage kidney failure in five to ten years. Treatment options are generally a kidney transplant or lifelong dialysis, neither which are curative. In fact, nearly 90% of transplant patients experience disease recurrence, and about half of them end up losing their transplanted organ.
Speaker Change: Treatment options are generally a kidney transplant or lifelong dialysis, neither which are curative.
Speaker Change: In fact, nearly 90% of transplant patients experience disease recurrence and about half of them end up losing their transplanted organ.
Caroline Baumal: The phase three Valiant study enrolled 124 patients with either C3G or primary ICMPGM. This is the largest single trial conducted in these populations and the only Phase three study to enroll a broad population inclusive of adolescent and adult patients with native and post-transplant forms of disease. The primary endpoint of the Valiant trial 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. We view success in this trial as the achievement of a statistically significant response to the primary endpoint, as well as positive effects in some of the additional secondary endpoint.
Speaker Change: The Phase 3 Valiant Study enrolled 124 patients with either C3G or primary IC MPGN. This is the largest single trial conducted in these populations.
Speaker Change: And the only Phase III study to enroll a broad population inclusive of adolescent and adult patients with native and post-transplant forms of disease.
Speaker Change: The primary endpoint of the Valiant trial 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.
Speaker Change: We view success in this trial as the achievement of a statistically significant response to the primary endpoint, as well as positive effects in some of the additional secondary endpoints.
Caroline Baumal: Physicians have shared that this would be clinically meaningful for these patients. If Valiant is positive, we plan to submit the supplemental NDA to the FDA for approval.
Speaker Change: Physicians have shared that this would be clinically meaningful for these patients.
Caroline Baumal: Following the completion of the Valiant Study, patients were given the option to enroll into the Val Long-Term Extension Study. We were highly encouraged to see that 100% of the patients who have already completed Valiant have now enrolled into Val.
Speaker Change: Following the completion of the Valiant Study, patients were given the option to enroll into the Vail Long-Term Extension Study.
Speaker Change: We were highly encouraged to see that 100% of the patients who have already completed Valiant have now enrolled into Vail.
Caroline Baumal: Beyond the Valiant Study, we are contented to continuing to advance our earlier stage pipeline, such as our C3-SIRNA that is currently in Phase 1 development and our Beam collaboration.
Speaker Change: Beyond the Valiant Study, we are continuing to advance our earlier-stage pipeline, such as our C3 siRNA that is currently in Phase I development, and our BEAM collaboration.
Caroline Baumal: Like Cedric said, we are excited to share more details about our pipeline programs with you as an Investor Day later this year.
Timothy Sullivan: I will now turn the call over to Tim for a review of the financials.
Timothy Sullivan: Tim?
Timothy Sullivan: Thank you, Caroline. I will now provide an overview of our financials and some comments on our debt refinancing with 6th Street. Additional details are available in the press release that we issued earlier this morning. Total revenue for the second quarter of 2024 was approximately 200 million, including 155 million in Cypher, and 24.5 million in Epile U.S. Net product revenue. This compares with 95 million in total revenue in the second quarter of 2023. Turning to the rest of the P&L, for the second quarter, cost of sales was 23 million, R&D expenses were 78 million, STA expenses were 128 million, and we reported a net loss of 38 million.
Speaker Change: I will now turn the call over to Tim for a review of the financials. Tim?
Tim Sullivan: Thank you, Caroline. I will now provide an overview of our financials and some comments on our debt refinancing with Sixth Street.
Tim Sullivan: Additional details are available in the press release that we issued earlier this morning.
Tim Sullivan: Total revenue for the second quarter of 2024 was approximately $200 million, including $155 million in Sipovri and $24.5 million in EmpaVeli U.S. Net Product Revenue.
Timothy Sullivan: As I previously stated, we are realizing efficiencies this year related to our restructuring in 2023 and continue to expect our total operating expenses in 2024, inclusive of R&D and SG&A expenses, to be less than our total expenses in 2023. This year, we've been focused on strengthening our balance sheet. These efforts ultimately resulted in a strategic, non-delutive refinancing collaboration with 6th Street that we announced in May. The deal allowed us to pre-pay our FFJ debt at a significant discount and to free up substantial cash flow. A quick look at the terms revealed how favorable this deal was.
Cedric Francois: As I previously stated, we are realizing efficiencies this year related to our restructuring in 2023 and continue to expect our total operating expenses in 2024, inclusive of R&D and SG&A expenses. This deal also substantially improves our liquidity and provides flexibility to access at least $200 million in incremental, non-dilutive capital as we continue to invest in profitable growth. Importantly, our ability to begin generating cash is possible in both the EU and non-EU scenarios. I don't think that's something... But thanks so much. Thanks so much for taking our questions. For more information, please visit www.fema.gov.
Speaker Change: As I previously stated, we are realizing efficiencies this year related to our restructuring in 2023 and continue to expect our total operating expenses in 2024, inclusive of R&D and SG&A expenses, to be less than our total expenses in 2023.
Speaker Change: The deal allowed us to prepay our SFJ debt at a significant discount and to free up substantial cash flow.
Timothy Sullivan: First, this debt facility provides us with up to 475 million, of which 375 million became available immediately upon closing. We can access the remaining 100 million at our option over time. Importantly, this deal was debt neutral to Appellus. We replaced 366 million in payments due to SSA over the next few years, with 375 million from 6th Street. The principal repayment is pushed out to May 2030, when cyclover revenues are expected to be closer to peak. Our payments are interest only until then. This deal also substantially improves our liquidity and provides flexibility to access at least 200 million in incremental non-delutive capital as we continue to invest in profitable growth.
Tim Sullivan: A quick look at the terms reveals how favorable this deal was. First, this debt facility provides us with up to $475 million, of which $375 million became available immediately upon closing.
Tim Sullivan: We can access the remaining $100 million at our option over time.
Speaker Change: Importantly,
Speaker Change: This deal was debt-neutral to Apellis. We replaced $366 million in payments due to SFJ over the next few years with $375 million from 6th Street.
Speaker Change: The principal repayment is pushed out to May 2030, when SIFOBRI revenues are expected to be closer to peak.
Speaker Change: Our payments are interest-only until then.
Timothy Sullivan: And it includes a record low credit spread. The overall terms were some of the best in biotech seen in recent history. In aggregate, since the beginning of the year, we have unlocked over 475 million in non-delutive capital, including 100 million from the cat call unwind announced in the first quarter. Plus, we have the flexibility to bring in 100 million within the Council's receivable line, which can be increased to 200 million upon the achievement of certain milestones, and 100 million more from 6th Street, so a total of 775 million in non-delutive financial flexibility. This combined with the 360 million in cash and cash equivalence that we have at the end of June 30, 2024, puts us in a strong financial position where we are on the path to becoming cash flow positive.
Speaker Change: And it includes a record low credit spread. The overall terms were some of the best in biotech seen in recent history.
Speaker Change: In aggregate, since the beginning of the year, we have unmarked over $475 million in non-dilutive capital, including $100 million from the cap call unwind announced in the first quarter.
Speaker Change: Plus, we have the flexibility to bring in $100 million within the accounts receivable line, which can be increased to $200 million upon the achievement of certain milestones, and $100 million more from 6th Street.
Timothy Sullivan: And no longer having to rely on the capital markets to fund the business. Importantly, our ability to begin generating cash is possible in both the EU and non-EU scenarios. While we believe the opportunity in Europe is significant, the ramp to peak sales is much longer, and so the main source of profitability in the near term remains growth in the US.
Cedric Francois: I will now hand the call back over to Cedric for closing remarks.
Cedric Francois: Cedric, thanks, Tim. We've had a very strong first half of the year with due successful commercial products, a pipeline of innovative programs in development, and a strong financial position to support the business. I am more confident than ever in our ability to continue creating significant value for our patients and our shareholders.
Speaker Change: I will now hand the call back over to Cedric for closing remarks. Cedric?
Cedric Francois: Thanks, Tim. You've had a very strong first half of the year.
Cedric Francois: With two successful commercial products, a pipeline of innovative programs in development, and a strong financial position to support the business, I am more confident than ever in our ability to continue creating significant value for our patients and our shareholders.
Operator: And we will now open the call for questions. Thank you.
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 11 again. We ask that you please limit yourself to one question and one follow-up.
Speaker Change: And we will now open the call for questions.
Speaker Change: Thank you. 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 11 again. We ask that you please limit yourself to one question and one follow-up. One moment while we compile our Q&A roster.
Operator: One moment; will we compile our Q&A roster?
John Miller: Our first question is going to come from the line of John Miller with Evercore. Your line is open. Please go ahead.
Speaker Change: Our first question is going to come from the line of John Miller with Evercore. Your line is open. Please go ahead.
Cedric Francois: Hi guys. Thanks so much for taking the questions. I would love to start with. I'll start with this. Do you expect the share of news starts? We currently, you know, around ethnic percent mark to grow again, post a successful ASRS. And then I guess the corollary to that is your guidance to cashflow positivity. You just mentioned doesn't assume anything more than US GA launches, but does it assume more than the existing share of new starts in the US?
John Miller: Do you expect the share of new starts currently, you know, around that 50% mark to grow again post a successful ASRS? And then I guess the corollary to that is...
Speaker Change: Your guidance to cash flow positivity, you just mentioned, doesn't assume anything more than U.S. GA launches, but does it assume more than the existing share of new starts in the U.S.?
Adam Townsend: Thank you so much on great to hear you. So, you know, that is of course the most important question, right? I mean, it is the news starts in the second quarter as we have discussed. There were tailwinds for I survey, but as we now move forward, what really stands out and what is very encouraging to see is the very large market. And the fact that, say for me, is leading on efficacy, flexible, those things and economic value. So as we move forward now, we plan to recapture the lead on those first injections and take advantage of this very large market with an important and met me.
Speaker Change: Thank you so much, John . Great to hear you.
Speaker Change: The most important question, right? I mean, is the news starts in the second quarter, as we have discussed?
Speaker Change: There were tailwinds for IZERVEH.
Speaker Change: But, as we now move forward, what really stands out and what is very encouraging to see is the very large market.
Speaker Change: and the fact that SIFO-V is leading on efficacy, flexible dosing, and economic value.
Speaker Change: So, as we move forward now, we plan to recapture the lead on those first injections.
Adam Townsend: Adam, do you want to add something?
Speaker Change: And take advantage of this very large market with an important unmet need.
Adam Townsend: Yes, thanks, Patrick.
John Miller: Hey, John. So yeah, we're in phase two, and we're already encouraged by the growth in the demand we're seeing into July. We're on the front foot. We're talking about advocacy. We're talking about every other month dose. And these are huge differentiating factors. This is a great drug. We can see the future, and we can see that we will continue to be the number one GA drug. In terms of cash flow, our revenue was $199.7 million, and our cash op-ex, if you take out stock-based confidence appreciation, it's just under that, so that was $199.199, a little bit less than that.
Speaker Change: We're on the front foot. We're talking about efficacy. We're talking about every other month dosing. These are huge differentiating factors for this great drug. We can see the future and we can see that we will continue to be the number one GA drug in this market.
Cedric Francois: So really, on a total op-ex basis, on a cash basis, we are net neutral. So the differences right now are working capital, and of course interest is spent. So it really doesn't take much in terms of growth for us to become a cash flow positive. We're not getting to when that will happen, but given the size of the market and the growth in this market, I don't think that's something we already know.
Speaker Change: You know, it really doesn't take much in terms of growth for us to become cashflow positive. We're not guiding to when that'll happen, but you know, given the size of the market and the growth in this market, you know.
John Miller: Great, make sense.
John Miller: And I guess my follow-up would be your language on EU approval seems more positive now than it has in the past. You mentioned that you're well positioned heading into this appeal, and I think that's a little bit more positive than the previous messaging we heard, where all of our assumption was that this was not the base case.
Speaker Change: Great. Makes sense.
Cedric Francois: But how do you feel now versus how you felt the last time you head into an appeal?
Cedric Francois: Do you really feel like the likelihood of an approval without further trials or without further resubmission is much higher now? Thank you, John. So the expectations should remain the same.
Speaker Change: But how do you feel now versus how you felt last time you had to an appeal? Do you really feel like the likelihood of an approval without further trials or without further resubmission is much higher now?
Cedric Francois: What is of course the one nice takeaway from the fact that the procedure was reset was the ability for us to introduce new data, and that includes the pre-specified endpoint function, which is of course something really important and encouraging and really speaks to the appeal of this reputation. So again, in terms of expectations, that has not changed. You know, the process has gone according to plan. We've been disciplined; we look forward to the fourth person to share with the results. Thanks so much.
Speaker Change: Thank you, John . So the expectation should remain the same. What is, of course, the one nice takeaway from the fact that the procedure was reset was the ability for us to introduce new data, and that includes the pre-specified endpoints of function.
Speaker Change: This is, of course, something really important, encouraging, and really speaks to the appeal of this drug to patients. So again, in terms of expectations, that has not changed. You know, the process has gone according to plan. We've been disciplined, and we look forward to the fourth quarter to share what the results
Operator: Thank you, and one moment as we move on to our next question.
Speaker Change: All right, thanks so much.
Anna Pam Ramma: The next question is going to come from the line of Anna Pam Ramma with JP, and your line is open. Please go ahead. Hey guys, thanks so much for taking the question. You guys noted that first cycle of re-June was your best months in launch. Maybe it gives a little more color on what you were seeing on a month-by-month basis in the quarter. You know, what the eyes are very sort of J code impact more like first half of the quarter dynamic and then you saw re-exceleration of cycle re growth, or how do we think about like what the dynamics were within quarter.
Speaker Change: Thank you and one moment as we move on to our next question.
Speaker Change: And our next question is going to come from the line of Anupam Rama with JPM. Your line is open. Please go ahead.
Anupam Rama: Hey, guys. Thanks so much for taking the question.
Adam Townsend: Thanks so much. Thank you so much.
Adam Townsend: I will head over to Adam, but I think again what stands out here and what we're super excited about is how large this market is. The fact that it's growing, the fact that Azerbaijan does well in a duopoly that, you know, will be here for a long time. And as having the drug that is meaningfully differentiated on efficacy and those infectability, that is really what we are focused on.
Speaker Change: The fact that it's growing, the fact that Azervay does well in a duopoly that will be here for a long time, and us having a drug that is meaningfully differentiated on efficacy and dosing flexibility, that is really what we are focused on.
Adam Townsend: But Adam, you may want to add something.
Adam Townsend: Yeah, hey, Adam Pam. So yes, you know, June was the highest month of the quarter and also the highest month of launch state. Across multiple metrics, we saw that Q2 was a very successful quarter for us across multiple months, right? We continue to grow accounts, now getting to 2,100 sites of care. We saw double-digit growth for the quarter. We're fully into phase two of our plan. I think some of the initial steps of that happening in June is what we can witness there, right? Talking about efficacy, talking about flexible dose. And I think that's what we're really pushing hard has been our move to the next.
Anupam Rama: And I think that's what we're really pushing hard as we now move to the next quarter.
Operator: Thanks so much for taking our question. Thank you.
Operator: And one moment as we move on to our next question.
Salveen Richter: And our next question comes from the line of Selveen Richter with Goldman Sachs. Your line is open. Please go ahead.
Speaker Change: And our next question comes from the line of Salveen Richard with Goldman Sachs. Your line is open. Please go ahead.
Cedric Francois: Hi, this is Sherna Tron for Salveen. Thank you so much for taking our questions. So on the competitive dynamics, what are the factors which are driving the competitive and physician dynamics in the GA market, following the Permanent J-code forizer wave? And could you speak to the market share that you're seeing at this point and how you expect that to evolve over the near term. Thank you so much for that question. So we are the market leader. We plan on continuing to be the market leader, and that confidence is based on stability around the safety, which was really important.
Speaker Change: We plan on continuing to be the market leader, and that confidence is based on
Cedric Francois: And where ASRS was a real turning point for us, right, was that for those of us that were there, it was a quiet meeting on that front. And the discussion is very much shifted towards the efficacy profile. And there's a majority of doctors clearly see the differentiation of safe ovary versus the competition. So as we now move forward, the focal points with more and more become efficacy, the differentiation, the long term data, the mass amount of data that we have with safe ovary. And then the real and important benefit of every other month, so the convenience that that offers the patients also the fact that health, the number of individual injections is twice as safe as not injections.
Speaker Change: Stability around the safety, which was really important, and where ASRS was a real turning point for us, right, was for those that were there, it was a quiet meeting on that front, and the discussion very much shifted towards the efficacy profile.
Speaker Change: And there, the majority of doctors clearly see the differentiation of safe ovary versus the competition. So, as we now move forward.
Adam Townsend: All of these things are going to come right to focus on the machine. Yeah, so obviously, if you go back to our J code, we also noticed tailwinds when we had our J code, unlocked certain new accounts. So the competitors that have some tailwinds, and even with those tailwinds, we maintained approximately 50% of news are and market leadership, 75% of the total market. That is down, et cetera, except to a real successful execution of base two of us strategic and plus some positive comments moving forward from ASRS. Now you also asked about market share. So we track market share based on vials going into physicians and then being injected into patients.
Cedric Francois: Sure, yeah, so, obviously, if you go back to our J-code, we also noticed Tailwinds when we had our J-code. It unlocked certain new accounts. We will continue to push incredibly hard on our efficacy message, our dosing convenience, and the economic value, and we think that that will maintain our leadership. Yeah, that will depend on the data, right? So I think you bring up a very important point, which is that the way in which the study reads out should be viewed in the context of, of course, what we have seen with Fabelta. We decided to include in one study both C3G and ICMPGN, with the hope that the data would be good enough for both to find their way into our labels.
Speaker Change: So, the competitor had some tailwinds, and even with those tailwinds, we maintained approximately 50% of new starts and market leadership at 75%.
Speaker Change: of the total market.
Adam Townsend: And so we think that's the most robust way of measuring market market share, and we had a 75% market share. Now, as this market grows, we will continue to push incredibly hard on our efficacy message, our dose inconvenience, and the economic value, and we think that that will maintain our leadership movement.
Operator: And as we move on to our next question.
Speaker Change: Thank you. Thank you. And one moment as we move on to our next question.
Yigal Nochomovitz: And our next question comes from the line of eGale note to move it with City Group. Your line is open. Please go ahead.
Speaker Change: And our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is open. Please go ahead. Thank you.
Cedric Francois: Hi, great. Thank you very much for taking the questions. Thank you very much.
Yigal Notremovitz: Hi, great. Thank you very much for taking the questions. Shifting over to CQG and ICMPGM.
Yigal Nochomovitz: Okay, yeah, sorry, Yigal. We had a hard time hearing a hear. Tim, who has a hearing for me. So, look, we are very excited about the opportunity in C3G and ICMP. Jen, as you know, this is something that has been a little bit below the radar screen of most, but a really large and important opportunity. For us, we have seen results from the Noble study, where we have the histopath data, which is really best in class ever seen within this disease. We also have, you know, already, while this drug is not on the market yet, seen the excitement around science for this drug, and we have seen in the noble study approximately 50% reductions in the protein area.
Speaker Change: Hello. We're running.
Speaker Change: Okay, yeah, sorry you guys, we had a hard time hearing you here. Tim, who has expired hearing, translated it for me. So, look, we are very excited about the opportunity in C3G and ICMPGN, as you know.
Cedric Francois: So, you know, that is, of course, the goal for us is to.
Cedric Francois: To meet statistical significance on the primary end point, and then to really pay attention to the transplant population, so. Yeah, I hope that answers your question.
Speaker Change: You know, that is, of course, the goal for us is to meet statistical significance on the primary endpoint, and then to really pay attention to the transplanted population. So yeah, I hope that answers your question.
Cedric Francois: No, that's helpful, and then I just have another question in terms of the design and value here, combining C3G and ICMP, Jen, into one study. Obviously, the competitor is doing separate studies for both indications. Do you see that as being a significant difference in terms of how physicians will interpret and implement the data when both of your. Yeah, that will depend on the data, right? So I think you bring a very important point, which is that the way in which the study reads out should be viewed in the context of, of course, what we have seen with Favelta.
Speaker Change: No, that's helpful. And then, I guess, another question, some people design and evaluate.
Speaker Change: Yeah, that will depend on the data, right. So I think you bring up a very important point, which is that
Speaker Change: The way in which the study reads out should be viewed in the context of, of course, what we have seen with Fabelta.
Cedric Francois: We decided to include in one study, both C3G and ICMP, Jen, with the hope that the data would be good enough for both to find their way into our label, so we're going to see if that's the case or not. And we're going to see how the data stacks up against what has already been disclosed by Novartis in the past months. Thank you.
Cedric Francois: So we're going to see if that's the case or not, and we're going to see how the data stacks up against what has already been disclosed by Novartis in the past. One thing we have noticed, and I don't know if Caroline wants to comment afterwards, is that a lot of physicians will have a discussion about cyphobrary, for example, with their patients and explain the efficacy profile and the flexibility. Caroline, anything you want to add?
Operator: Thank you in one moment as we move on to our next question.
Speaker Change: Great, thank you.
Steve Seahouse: And our next question is going to come from the line of Steve Seahouse with Raymond James. Your line is open. Please go ahead.
Speaker Change: And our next question is going to come from the line of Steve Seedhouse with Raymond James. Your line is open. Please go ahead.
Steve Seahouse: Thank you. Good morning. Thanks for the update.
Timothy Sullivan: First question, I just regarding a new line item on the balance sheet for long-term inventory at $23 million entry. Does there been any change to the expected sales trajectory in the next 12 months versus prior? Are you anticipating that entry will be gone in subsequent quarters, or is it going to grow? And then also, what is the shelf life of the raw materials? I guess they comprise that entry.
Timothy Sullivan: Yeah, thanks, Steve. So that entry was put in place because we have to do our ordering for our inventory long in advance, and we had planned for the potential success of the ALF. There's also a couple of other factors, which include the delay in the EU for size over, and also are expected ordering from, so we have to plan for all that well in advance.
Timothy Sullivan: And so much of that, in fact most of it, has to do with. So we don't know exactly how long that you know that line item will last there, but. Most of that inventory has a shelf life of, you know, three years or more. So we just put that in place, you know, because of the dynamics we talked about. But it's, yes, I'm early. Okay, good to know.
Steve Seedhouse: Most of that inventory has a shelf life of, you know, three years or more, so we just put that in place, you know, because of the dynamics we talked about, but it's...
Adam Townsend: And then, just on the dynamic of patients, maybe switching between eyes or they and syphovery.
Steve Seedhouse: Okay, good to know. And then just on the dynamic of patients maybe switching between Izervei and Cyfovir,
Adam Townsend: Has that, do you have good visibility into both directions of switching there, and has it been, if so. Has it been sort of a net positive, net negative, or net neutral in terms of unique patients on either drug.
Adam Townsend: Thanks.
Adam Townsend: Hey Steve, it’s Adam. So yes, we have, we have some visibility to that now. Obviously, with all analysis that we can do, it's only a subset of the total market. So obviously last year we did see some switching from Syphovery to Isave. We saw one or two accounts; switch the majority of that.
Speaker Change: Thanks.
Speaker Change: Hey Steve, it's Adam. So, yes, we have some visibility to that now, obviously, with all analysis that we can do, it's
Adam Townsend: And what we have seen moving forward is we've actually seen some switching from eyes of eight come back to syphovery, and our assumption there is that space on the axis and the flexible dosing of this drug. Switching tends to be a very small piece of the market, and it goes both ways based on our data set.
Steve Seedhouse: And what we have seen moving forward is we've actually seen some switching from Isovape to come back to Cyfovir. And our assumption there is that's based on the efficacy.
Speaker Change: Switching tends to be a very small piece of the market, and it goes both ways based on our data set. As we look forward into Q3 and beyond, right, we're really, really encouraged by all of the metrics we're seeing about strong demand across multiple metrics.
Adam Townsend: As we look forward into Q3 and beyond, right, we're really, really encouraged by all of the metrics we're seeing about strong demand across multiple metrics. That includes switching as a piece of it, a small piece of it that includes new starts and our plan to execute everything to push new starts. It includes more physicians writing syphovery for the first time and increasing the number of accounts that are using syphovery. We're really, really positive on what we're seeing so far. And we think a lot of that's down to this strong efficacy, that leading accuracy, flexible dose, and economic balance.
Speaker Change: It includes more physicians writing cyfovery for the first time and increasing the number of accounts that are using cyfo.
Speaker Change: We're really, really positive on what we're seeing so far, and we think a lot of that's down to this strong efficacy, the leading efficacy, flexible dose, and economic balance. Hopefully, Steve, that answers your question.
Steve Seahouse: Hopefully, Steve, that answers your question. Yes, thanks for watching.
Operator: Thank you very much. Thank you, and one moment as we move on to our next question.
Steve Seedhouse: Yes, thanks so much, Adam. Thank you very much.
Colleen Kusy: And our next question is going to come from the line of calling Kuzi with Bairg. Your line is open. Please go ahead.
Speaker Change: Thank you, and one moment as we move on to our next question.
Colleen Kusy: Great. Thanks.
Colleen Kusy: Good morning, and thanks for taking our questions. Can you provide any thoughts on when you might provide revenue guidance for Syphovery? Sure, thank you. So obviously we're not providing it for the remainder of this year, and it's something we'll reconsider for next year. We're not guiding on that yet. Thank you.
Speaker Change: Great, thanks. Good morning and thanks for taking our questions. Can you provide any thoughts on when you might provide revenue guidance for SIPO3?
Cedric Francois: And then for the EU review, I think you said the rapid tours have been selected.
Cedric Francois: Can you, can you, can you find any commentary on the background of the new rapid tours and if other of them were a dissenting voter from the most recent review? Thank you so much, Colleen.
Speaker Change: Thank you. And then for the EU review, I think you said the rapporteurs have been selected. Can you provide any commentary on the background of the new rapporteurs and if either of them were a dissenting voter from the most recent review?
Colleen Kusy: So we don't provide details on that. As mentioned, we consider the odds of success to have remade stable the process to have gone very much in line with what we had expected, and hopefully in the fourth quarter will be able to come back with positive news. Understood. Thanks for taking our question.
Operator: Thank you, Colleen. Thank you in one moment as we move on to our next question.
Speaker Change: Understood. Thanks for taking our questions.
Philip Nadeau: And our next question is going to come from the line, as Phil may do with TD Cowan. Your line is open. Please go ahead.
Philip Nadeau: Morning. Thanks for taking our questions on the competitive environment.
Cedric Francois: First, I'm a pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro pro 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Speaker Change: Morning, thanks for taking our questions on the competitive environment first.
Speaker Change: Can you talk a little bit more about what you're seeing from your competitors in terms of this cap and a little bit more about the pellet defense strategy planning?
Speaker Change: And second, the dynamics of competition, what do you think of position and center level overall? Are students becoming iso-very versus at-risk positions or positions using both?
Speaker Change: 1 versus the other, or are they using both? If they're using both, how are they choosing?
Speaker Change: Hey, Phil, I don't know if it's our line or yours, but we have a very hard time hearing your questions.
Speaker Change: And then second, I have a petition. Can you talk about on the patient, sorry, on the physician center level, are centers choosing one or the other, or are they going patient by patient in using Isovape versus SepoBridge? Thanks.
Speaker Change: Thank you so much. Adam, do you want to take that? Yeah. Hey, Bill. Thanks for repeating the question.
Speaker Change: This is a large and growing market and we've only just scratched the surface of moving patients into the market.
Speaker Change: So, if you look forward to how big this market can possibly be, we want to maintain as much value as is possible, so we've been incredibly thoughtful on contracting.
Caroline Baumal: One thing we have noticed, and I don't know if Caroline wants to comment afterwards, is a lot of physicians will have a discussion about syphilis, for example, with their patient and explain the efficacy profile and the flexible medicine.
Caroline Baumal: That patients have completed the Gale study, some patients with over five years of continuous use of Cyfovir. So, to them, the most important thing is to give the maximum efficacy with the least burden for patients.
Cedric Francois: That's helpful. Thank you.
Operator: Thank you, and one moment as we move on to our next question.
Caroline Baumal: That's helpful. Thank you.
Akash Tewari: Our next question comes from the line of Akash Tewari with Jeff Rees. Your line is open. Please go ahead.
Speaker Change: Thank you, and one moment as we move on to our next question.
Akash Tewari: Hey, this is Amy Onthoracos. Thank you so much for taking her question. So you've alluded to a safety update second half of this year.
Cedric Francois: Just wanted to get a sense of what that couldn't tell.
Cedric Francois: Also, given Isurvey has the amount of peg in a shorter half-life compared to side ovaries, are you working with ASRS or doctors to run studies looking at dose titration or spaced out dosing regimens for side ovaries? And when can we get an update on that? Thank you so much for that question. So first of all, the safety is now very clear and well established. So the end what was really important for us was that SRS that the SRS rest committee agreed with us. With that, it is on the rarity of these events, one in four thousand on the first injection and the fact that this is primarily a first injection phenomenon, right?
Adam Townsend: That's helpful. Thank you. Thank you so much for that question. So, first of all, adopt some of these tools so they can demonstrate to their patients that this is working. Thanks. Thank you, Annabel. Adam is going to first answer the first part of the question.
Cedric Francois: So those are important facts. And of course, then you places in the broader context of the safety where side ovaries tax up very well against Isurvey, specifically also because of that every other month dosing that is available. So, you know, based on an enormous denominator of 330,000 injections. We know very well what the safety profile is.
Speaker Change: 1 in 4,000 on the first injection.
Speaker Change: And the fact that this is primarily a first injection phenomenon, right? So those are important facts. And, of course, then you place it in the broader context of the safety where SIFO-V stacks up very well against IZER-V.
Speaker Change: Specifically also because of that every other month, those things that is available. So.
Cedric Francois: I don't think there's going to be much more discussion around that. What we will talk about a lot about now is what the efficacy really looks like. And I think that is where the discussion is going to go. What was really gratifying to see coming out of ASRS is that everything is becoming more quiet and more reasoned within this field. So only 13% of patients with GA right now have been treated. These patients are desperate for treatment. They are going blind. Understanding the safety profile and the efficacy that they get in return is really important and is going to drive to close all this market for many years to come.
Speaker Change: I don't think there's going to be much more discussion around that. What we will talk a lot about now is
Speaker Change: What was really gratifying to see coming out of ASRS is that everything is becoming more quiet and more reasoned within this field.
Speaker Change: So, only 13% of patients with GA right now have been treated.
Cedric Francois: So that is something that really stood out in terms of mitigations for something as rare as this event.
Cedric Francois: And you know, it is a question: what can you do? What should you do? It's, of course, you know, when it happened, it's not good. But, you know, interdisciplinary injections carry a risk every time you do an intervention injection. There's a chance of one in three to 5,000 getting infections in the stomach as well. That is normal with any type of drug. So this is really something that we're looking forward to.
Speaker Change: You know, intravitryl injections carry a risk. Every time you do an intravitryl injection, there's a chance of 1 in 3 to 5,000 of getting infections of thalamitis as well. That is normal with any type of drug. So
Caroline Baumal: I don't know if Caroline wants to add something.
Caroline Baumal: I think the retina community has really appreciated our transparency with this and our partnership. I mean, we are driven by science, and we're driven by what's going to be best for patient care. And that is the continual feedback, and I will tell you that the community would have no problem giving different sort of feedback if that was indicated. So they're really pleased with this, and they're really excited to continue to work with us and develop more data for our patients to give them the best care.
Speaker Change: And they're really excited to continue to work with us and develop more data for our patients.
Cedric Francois: Yeah, and we're really feeling that moment in this quarter, right?
Cedric Francois: I mean, it's really, I think SRS wasn't real training. Great.
Speaker Change: To give them the best care.
Operator: Thank you so much.
Speaker Change: I think SRS was a real turning point for us.
Elie Marie: Thank you, and one moment as we move on to our next question.
Speaker Change: Great, thank you so much.
Elie Marie: And our next question is going to come from the line of Elie Marie with UBS. Your line is open. Please go ahead.
Speaker Change: And our next question is going to come from the line of LA Marie with UBS. Your line is open. Please go ahead.
Elie Marie: Thanks for taking the question. Just a quick one on Psycho Ray and then a question on Valiant. Sorry if I missed this before, but can you confirm if volumes were up in July versus June for Psycho Ray. And then for Valiant, just how are you thinking about what's clinically meaningful in the pre versus post transplant setting? And then any difference in efficacy expected between these two settings and just commercially, how you're thinking about the relative size of the population opportunity for PECSETA CLOPE plan in the pre versus post transplant patients. Thanks. Thank you so much.
LA Marie: Hey, guys. Thanks for taking the question. Just a quick one on Sifo-Re and then a question on Valiant. Sorry if I missed this before, but can you confirm if volumes were up in July versus June ?
Speaker Change: First, I thought Ray and then.
Speaker Change: For Valiant, just how are you thinking about what's clinically meaningful in the pre versus post-transplant setting?
Speaker Change: And then any difference in efficacy expected between these two settings and just commercially how you're thinking about the relative size of the population opportunity for pexediclopan in the pre-versus post-transplant patients. Thanks.
Caroline Baumal: I don't do want to think this is real.
Adam Townsend: Kaya, yes, so we're really thrilled with the strong growth because it's continuing into July, and we expect it to continue for the rest of the quarter. And I know what we're seeing across multiple metrics. And I think it's down a lot to floor this execution of phase two of our plan. We are now on the front foot, and we're pushing car. So we're thrilled with what we're seeing into July. We expect that to continue. We're going to work hard to make sure.
Speaker Change: Thank you so much. Adam, do you want to take this first question? Sure. Yes, so we're really thrilled with StrongOath because it's continuing into July and we expect it to continue.
Speaker Change: For the rest of the quarter and onwards, we're seeing it across multiple metrics, and I think it's down a lot to flawless execution of phase two of our plan.
Speaker Change: We are now on the front foot and we're pushing hard.
Speaker Change: So, we're thrilled with what we're seeing into July . We expect that to continue. We're going to work hard to make sure.
Caroline Baumal: And then, as it relates to Valiant, so pre versus post transplant.
Cedric Francois: So, as you know, you may recall, Elie, for us, the post-transplant segment is a very intriguing one because it's easy to take biopsies and to track on histopathology what your direct does in that population. This is also a population that was kind of deprioritized by our competitors, and it's one that we happily embrace because what is best for transplanted kidney is best for kidneys with this disease, period. So this is really something that has as many advantages for us to focus on.
Speaker Change: And then as it relates to valiance, so pre versus post-transplant, so as you know, you may recall, Elie, for us, the post-transplant segment is a very intriguing one because it's easy to take biopsies and to track on histopathology what your drug does in that population.
Speaker Change: It is also a population that was kind of deprioritized by our competitors, and it's one that we happily embrace because what is best for a transplanted kidney is best for kidneys with this disease, period.
Cedric Francois: But, on the other hand, should our data be really good and valiant. There is a real opportunity to differentiate from Fabalta. And you know, in a disease as serious as C3G or ICMPGN, you know, efficacy is what will really, really matter more than convenience, right? Whether you take a pill or subcutaneous, if you have a real differentiation on efficacy, that is what will stand up.
Elie: So this is really something that...
Elie: has many advantages for us to focus on. But on the other hand, should our data be really good and valiant?
Speaker Change: There is a real opportunity to differentiate from Fabelta and to know in a disease as serious as C3G or ICMPGN.
Cedric Francois: I also want to point out, of course, we've always talked about the remarkable safety profile that we've seen in PNH and the other indications where Empathy has been used and is on the market, combined with this extraordinary compliance rate of 97%. Empavetti has the same active ingredient that Cypherry is an amazing drug, and hopefully in Valiant, we will see a new indication emerged for that drug. Great.
Speaker Change: If you have a real differentiation on efficacy, that is what will stand out.
Speaker Change: I also want to point out, of course, we've always talked about the remarkable safety profile that we've seen in PNH and the other indications where Empavedi has been used and is on the market, combined with this extraordinary compliance rate of 97%.
Speaker Change: And Pavetti, which has the same active ingredient as Cyfovir, is an amazing drug, and hopefully in Valiant we will see a new indication emerge for that drug.
Operator: Thank you in one moment as we move on to our next question.
Annabel Samimy: And our next question comes from the line of Annabelle Seminy with Cecil. Your line is open. Please go ahead.
Annabel Samimy: Hi, all. Thanks for taking my call. So I guess in our channel, check if we're happy to find that consensus among these positions we spoke through is generally in line with your comments that physicians give Cypherry that edge on efficacy. I guess my question is, how are they responding to the microprimetry data because it's not something that they typically do in their offices. So how can they use that with their patients practically so they can show patients benefit over time and keep them motivated. And I asked that I guess for retention beyond that, say 18 months into your time frame where patients may start dropping off.
Speaker Change: Hi, all. Thanks for taking my call. So, I guess in our channel checks, we're happy to find that consensus among these physicians we spoke to is generally in line with your comments that physicians give psychotherapy that edge on efficacy. I guess my question is,
Caroline Baumal: Do they have the tools right now, and are they starting to adopt some of these tools so they can demonstrate to their patients that this is working.
Adam Townsend: Thanks. I appreciate your comments on XC. We also did a recent piece of market research, and we noticed in our sentiment 2 on market research that our XC perceptions increasing, and there's a gap between us and the competitor in our market research. It seems to confirm what you said.
Adam Townsend: Thanks, Annabel. I so appreciate your comments on efficacy. We also did a recent piece of market research, and we noticed that in our sentiment to our market research, that our efficacy perception is increasing, and there's a gap between us and the competitor in our market. Hi, thanks for the question here. So I was just wondering, so in terms of, you know, function, we've discussed, but convenience and the importance of that and the economic value, can you help us understand a little bit more about convenience. Is that as advantageous to the physician as it is to the patient? I'm just trying to understand if convenience and economic value here have a correlation or not.
Adam Townsend: Thank you Annabel. Adam is going to first. Thanks Annabel. So I appreciate your comments on efficacy. We also did a recent piece of market research and we noticed in our sentiment to our market research that our efficacy perception is increasing and there's a gap between us and the competitor in our market research.
Caroline Baumal: I'll hand over to Caroline on microphone.
Caroline Baumal: Thank you, Adam. Physicians are really excited about the microprimatory data, and in showing them, they see the trend in the microprimatory data that's followed over time and that reaches this pre-specified endpoint. I think that most physicians realize that microprimatory, in many ways, is analogous to a visual field testing, and they appreciate that it shows the benefit in the clinical trial, but in the real world, they like to use OCT, which also has shown benefits using our AI algorithms combined with the University of Vietnam.
Speaker Change: And they appreciate that it shows a benefit in a clinical trial, but in the real world they like to use OCT, which also has shown benefits using our AI algorithms.
Caroline Baumal: So I think the fact that we have this pre-specified endpoint, though, is very highly meaningful, and it will mostly be used today in clinical studies. Although some people are using microprimatory in the real world, in the real world we can use imaging to show this to patients, and we have cases that we've shown to physicians. In fact, we show one at ASRS where patients in the observed fellow eye, the geographic atrophy grew three times as much compared to the treated eye. So cases like this are highly meaningful, and that was in the Matt McComber's video talk at ASRS.
Operator: Thank you, and one moment as we move on to our next question.
Francois Brisebois: Our next question is going to come from the line of Francois versus Boyce with Oppenheimer. Your line is open. Please go ahead.
Speaker Change: Thank you and one moment as we move on to our next question.
Cedric Francois: Hi, thanks for the question here. So I was just wondering, so in terms of, you know, function we've discussed, but on convenience and in the importance of that and the economic value, can you help us understand a little bit from the convenience? Is that as advantageous to the physician, as it is to the patient? I'm just trying to understand if convenience and economic value here have a correlation or not. Thank you, Francois.
Cedric Francois: Well, there's three pieces to that question, right? There's to convenience to the patient, convenience to the physician, and then the convenience is quite frankly to the bear. So when we start with the convenience to the patient having every other month, those things available is really, really important. Our competitor, if there are some off-level use with every other month, but our competitor has only monthly, we're going to find out that, you know, this year, if they actually ever get every other month in their label. This is a benefit, meaningfully, from should it end up the way we think.
Speaker Change: When we start with the convenience to the patient, having every other month dosing available is really, really good.
Caroline Baumal: The advantage to physicians of every other month is against flexibility. And, you know, I'm going to let Caroline answer like her view on that, and then have Adam dive into the bear aspect of the cost, the value. Well, certainly to realize the anatomic benefits of psychoverate, we've seen that every other month dosing is meaningful. And I think that with our flexible aggregate 25-60 days in our label, patients can come every six to eight weeks and still realize these meaningful effects. And certainly in the US, physicians love to have that plus minus one to two weeks with their dosing.
Speaker Change: It should end up the way we think.
Speaker Change: The advantage to physicians of every other month is again the flexibility and you know I'm going to let Caroline answer like her view on that and then have Adam dive into the payer aspect of it.
Adam Townsend: Well, certainly, to realize the anatomic benefits of Cypovry, we've seen that every other month dosing is meaningful, and I think that with our flexible every 25 to 60 days in our label, patients can come every six to eight weeks and still realize these meaningful effects. And certainly in the US, physicians love to have that plus minus one to two weeks with their dosing, and it's more likely for patients to come in and complete this. We know that with monthly dosing from our anti-VEGF experience, it's really, very difficult to complete that, and patients will often drop out because they cannot maintain it. Adam?
Caroline Baumal: Well, certainly to realize the...
Caroline Baumal: We've seen that every other month dosing is meaningful, and I think that with our flexible every 25 to 60 days in our label, patients can come every six to eight weeks and still realize these meaningful effects.
Speaker Change: and certainly in the U.S.
Timothy Sullivan: And it's more likely for patients to come in and complete this. We know that with monthly dosing from our anti-vegetics experience, it's really very, very difficult to complete that, and patients will often drop out because they cannot maintain that. Yeah, thanks.
Speaker Change: experience, it's really very, very difficult to complete that, and patients will often drop out because they cannot maintain that. Adam? Yeah, thanks. So, obviously, we were thrilled that some payers are starting to look at this category
Adam Townsend: Yeah, thanks. So obviously, we're thrilled that some payers are starting to look at this category. Okay, and just lastly, on the Valiant data, just because it's coming up very shortly here, you guys discussed in terms of success and expectation, StatSig on the primary, but on the secondary, in terms of, is this a positive trend on, you know, some secondary endpoints or all, and is this what the regulators need to see from conversations, or just trying to understand more about the secondary endpoints importance? Our next question comes from Your line is open. Please go ahead. Hi, good morning.
Cedric Francois: So obviously we were thrilled that some payers are starting to look at this category and selecting psychoveries for a choice. So this decision was basically made on its robust efficacy profile, particularly the increasing effects over time. And I think it's really basically simple, right? Phypoveries efficacious with monthly and every other month dosing. And this is good for patients and is economically supported for the health plan. And I think that's going to be important for us as this market continues to grow and become bigger.
Cedric Francois: And you know, context there is that the flexibility is everything, right? Some patients with aggressive lesions want to be those monthly. We have seen very clearly in Gale as well that there are advantages to feeding monthly, right? I mean, it is more intense from those in perspective, of course, but in terms of reducing the living growth, there is an advantage to monthly.
Adam Townsend: And, you know, the context there is that...
Adam Townsend: The flexibility is everything, right? Some patients with aggressive lesions want to be dosed monthly. We have seen very clearly in Gail as well that there are advantages to treating monthly, right? I mean, it is more intense from a dosing perspective, of course.
Cedric Francois: So that's flexibility; the huge amount of data that we have, both in its absolute, but also longitudinally over time. We have three years now; we will have more data coming. All of that's incredibly valuable.
Caroline Baumal: But in terms of reducing the lesion growth, there is an advantage to monthly. So that flexibility, the huge amount of data that we have, both, you know, in its absolute, but also longitudinally over time, we have three years now, we will have more data coming, all of that's incredibly valuable.
Caroline Baumal: Okay, and just lastly on the valiant data just because it's coming up very shortly here, you guys discussed in terms of success and expectation, you know, stats say on the primary, but on the secondary in terms of is this the positive trend on, you know, some secondary endpoints are all, and is this what the regulators need to see from conversations, are just trying to understand more on the secondary endpoints importance here. Yeah, the secondary endpoints, you know, need to trend supportive of the primary endpoints. You know, we have seen this with Favelta where none of the secondary endpoints were met.
Speaker Change: Okay, and just lastly on the Valiant data, just because it's coming up very shortly here, you guys discussed in terms of success and expectations.
Speaker Change: you know, StatSig on the primary. But on the secondary, in terms of is this the positive trend on, you know, some secondary endpoints or all? And is this what the regulators need to see from conversations? They're just trying to understand more on the secondary endpoints importance here.
Speaker Change: The secondary endpoints need to trend supportive of the primary endpoints. We have seen this with Fabalta, where none of the secondary endpoints were met.
Caroline Baumal: But where you know, we believe there is still a path forward for Favelta, they were specifically asked to, you know, submit the data at one year, as you may recall, after having the six month primary endpoints. Those are all things; secondary endpoints are more contextual, but very important to provide support to what we measure with the primary endpoints and the secondary endpoints.
Speaker Change: But we are, you know, we believe there is still a path forward for Fabelta.
Speaker Change: They were specifically asked to, you know, submit the data at one year, as you may recall, after having the six-month primary endpoint. Those are all things, secondary endpoints are more contextual, but very important to provide support to what we measure with the primary endpoint.
Operator: Thank you, and one moment as we move on to our next question.
Speaker Change: Thank you and one moment as we move on to our next question.
Douglas Tsao: Our next question comes from the line of Douglas.
Douglas Tsao: So with H.C. Lanewright, your line is open. Please go ahead. Hi, good morning.
Speaker Change: Our next question comes from the line of Douglas Tsao with HC Wainwright. Your line is open. Please go ahead.
Adam Townsend: Thanks for taking the questions. I'm just curious, Adam, in terms of the patients that are now being treated, I think in the past you indicated that, like, 90% of them were already on the books of retina specialists. I'm just curious if that continues to be the case. And then, in terms of the DTC work that you have done, for the most part, I think the Henry Winkler campaign has sort of been an unbranded campaign.
Adam Townsend: Thanks for taking the questions. I'm just curious, Adam, in terms of the patients that are now being treated. I think in the past you indicated that, like 90% of them had, were already on the books of retina specialists. I'm just curious if that continues to be the case.
Douglas Tsao: Hi, good morning. Thanks for taking the questions. I'm just curious, Adam, in terms of
Adam Townsend: And then in terms of the DTC work that you've gone for the most part, I think the Henry Winkler campaign has sort of been an unbranded campaign. Does there come a point where you might consider, now that you're quote on, you know, sort of in phase two, switch to a branded DTC effort to sort of focus on the competitive dynamics and attributes of Cyphervery versus the Azerbaijan? Yeah, thanks. So yeah, this is obviously a large and growing market with 13% market constraints for the current approved therapies. And most of those patients, in fact, the vast majority of those patients were already on the books of redness specialists.
Douglas Tsao: And then in terms of the DTC work that you have done, for the most part, I think the Henry Winkler campaign has sort of been an unbranded campaign. Does there come a point where...
Adam Townsend: Does there come a point where you might consider, now that you're quoted on, you know, sort of in phase two, switching to a branded DTC effort to sort of focus on the competitive dynamics and the attributes of syphilis versus Isorbe? So Henry was educating the world about going and getting your eyes checked.
Speaker Change: You might consider, now that you're quote on, you know, sort of in phase two, switch to a branded DTC effort to sort of focus on the competitive dynamics and the attributes of Cypho-Re versus Iso-Re.
Speaker Change: Yeah, thanks. So yeah, this is obviously a large and growing market with 13% market penetration for the current approved therapies. And most of those patients, in fact, the vast majority of those patients, were already on the books of retina specialists. So they're tapping into the patients that have GA that they were perhaps seeing that had other complications.
Adam Townsend: So they're tapping into the patients that have GA that they were perhaps seeing that had other complications.
Adam Townsend: For example, one thing phase two of our plan is super critical. And DTC DTC is also a part of it. Is that we are going to educate ophthalmologists and optometrists on geographic attributes as a disease. And once you start to educate those physicians, they will be able to potentially refer viable patients to redness specialist treatment. We see this is a really big market, and actually facilitating education is going to help us. So DTC, yes, Henry Winkler was diseased their education. It was incredibly well received by patients, but also by physicians.
Speaker Change: For example, one thing phase two of our plan is super critical, and ETC is also a part of it, is that we are going to educate ophthalmologists and optometrists
Douglas Tsao: We see this as a really big market and actually facilitating that education is only going to help us move forward.
Adam Townsend: We did transition as part of phase two to branded DTC. So Henry was educating the world about Go and get the rise check. And branding DTC is talking about Cypherry and the benefits of the efficacy that Cypherry can so that patients are educated on the disease and then they can go and ask if to have a conversation. As we progress moving forward, we're going to push DTC with a real strong approach on actual cypherry and get some exciting things happening with Henry Winkler. Great.
Adam Townsend: And Brandy DPC is talking about syphobry and the benefits of the efficacy of syphobry so that patients are educated on the disease, and then they can go and ask a patient to have a conversation about syphobry. Great, thank you so much. Thank you, and one moment as we move on to our next question. And with the headwinds the competitors had, we were still maintaining approximately 50% of new starts. And I think that's really, really strong considering it was the quarter of the edging. And we don't get old.
Operator: Thank you so much.
Brian Amman: Thank you, and one moment as we move on to our next question.
Brian Amman: Our next question comes from the line of Brian Amman with Piper Sandler. Your line is open. Please go ahead.
Speaker Change: Thank you, and one moment as we move on to our next question.
Adam Townsend: Yeah.
Adam Townsend: Hi, guys. Thanks for taking my question.
Adam Townsend: Maybe if I could start with the competitive dynamic. Estelle is earlier today on their call. You know, state that their seeing eyes are very capturing majority of new patient starts. Are you seeing similar trends from your treatment use market research data? Thank you. Yeah. So we are seeing through our data set, which is not market research. We use a data set that actually tracks files into a physician site and then into our patient. So we believe in the robustness of this, but we could do market research. And I think you get some bias when you do market research.
Speaker Change: Yeah, hi guys. Thanks for taking my question. Maybe if I get to start with, you know, the competitive dynamic. I think Estella's earlier today on their call.
Speaker Change: Um, you know, stated that they are seeing eye survey capturing a majority of new patients starts. Are you seeing similar trends from your treatment use market research data?
Adam Townsend: And with the heads of headwinds, the competitors have, we were still maintaining approximately 50% share of new starts. And I think that's really, really strong considering it was the quarter of their J code. So that's how we look at the date that we believe 75% market share of total market is a very robust number. And we look to the future of how big this market can be and being the number one GA product in it.
Douglas Tsao: attend.
Speaker Change: With the headwinds the competitors had, we were still maintaining approximately 50% share of new starts, and I think that's really, really strong, considering it was the quarter of their J-code.
Speaker Change: So that's how we look at the data set. We believe 75% market share of total market is a very robust number and we look to the future of how big this market can be and being the number one GA product in it.
Timothy Sullivan: Great. That's helpful in terms of data point, and then maybe if I could have a follow-up. So, on the quarter, it seems, you know, commercial units grew about 10% quarter of a quarter. If you take out samples, like sales grew about 12% quarter of a quarter.
Timothy Sullivan: So is the remainder from Laura grossennet in the quarter, and what should we expect for grossennet for the third quarter? So gross to net, obviously we don't say exactly what gross to net is. It did go up slightly this quarter, but was really well within the range of where it was last quarter. And in terms of the files out, you know, that those are the accurate numbers, and then we don't guide more numbers.
Speaker Change: Sure. Thanks, Bryn. So, so gross to net, you know, obviously we don't say exactly what gross to net is. It did go up slightly this quarter, but, but was really well within the range of where it was last quarter.
Speaker Change: And in terms of the files out, you know, those are the accurate numbers, and...
Brian Amman: Great, thanks for taking my questions.
Operator: Great. Thanks for taking my question. Yeah, thanks for the question. So obviously, seasonality is an important metric to measure here. Every time we go to a big retina conference like ASRF a couple of weeks ago, right? A large proportion of physicians are there. So there are multiple retina meetings moving forward where physicians will be, you know, attending those conferences and learning about our efficacy data. All right, thanks very much. Okay.
Operator: Thank you in one moment.
Speaker Change: Great. Thanks for taking my questions.
Operator: And our last question is going to come from the line of Graig Suvannavejh with Mizuho Securities. Your line is open. Please go ahead.
Speaker Change: Thank you, and one moment.
Douglas Tsao: And our last question is going to come from the line of Graig Suvannavejh with Mizzou Host Securities. Your line is open. Please go ahead. Thank you. Thank you. Thank you.
Graig Suvannavejh: Great, thanks.
Cedric Francois: Thank you for taking my question. I just wanted to follow up on earlier in the year comments around seasonality and how that impacted the first quarter in particular, and just wondering if you've got second quarter now behind you. If you can provide us any commentary on what you're expecting. If anything around seasonality impacts in the third and fourth quarter, just as we think about modeling. I'm safe; I'll be revenue on a go for basis. Thanks.
Graig Suvannavejh: Great, thanks. Thank you for taking my question. I just wanted to follow up on earlier in the year comments around seasonality and how that impacted
Speaker Change: The first quarter in particular, and just wondering as you've got second quarter now behind you, if you can provide us any commentary on what you're expecting, if anything, around
Douglas Tsao: Seasonality impacts in the third and fourth quarter just as we think about modeling SIFO-V revenue on a go-forward basis. Thanks.
Caroline Baumal: Yeah, thanks for the question. So obviously seasonality is an important metric to measure here every time we go to a big retina conference like Ads are at a couple of weeks ago, right. A large proportion of physicians are there. So there are multiple right the meetings moving forward where physicians will be out, you know, attending those conferences and learning about our efficacy data. Caroline, I think we want to add from your retina physician. That's, you know, the retina physicians are really looking forward. We have some upcoming exciting presentations, and you know they want to offer patients a product that's going to be effective with increasing effects over time.
Speaker Change: A large proportion of physicians are there, so there are multiple meetings moving forward where physicians will be out, you know, attending those conferences and learning about our efficacy data.
Caroline Baumal: Caroline, anything you want to add from your retina physician perspective?
Caroline Baumal: So they are very motivated and looking forward to working with us on analyzing the data.
Caroline Baumal: It's going to be effective with increasing effects over time, so they are very motivated and looking forward to working with us on analyzing the data.
Cedric Francois: And just a follow-up, is anything, just anything, on like purchasing patterns, you know, seasonally, third quarter versus fourth quarter. Bigger picture. I don't think we've had enough experience yet to really say that, at least in our, you know, terms of this market and digest. There's anything that stands out particularly, I mean, not to say you have honest and that can be a small month. Well, there's nothing really. Okay, thanks very much.
Speaker Change: And just as a follow-up, is there anything on like purchasing patterns, you know, seasonally, third quarter versus fourth quarter?
Speaker Change: Bigger picture.
Speaker Change: I don't think we've had enough experience yet to really say that, at least in our, you know, in terms of this market. Anti-digestive isn't anything that stands out particularly. I mean, obviously, you have August .
Speaker Change: That can be a full month just because of vacations.
Speaker Change: There's nothing really dramatic.
Cedric Francois: Thank you.
Cedric Francois: And I'm sure, as I said, there's no further questions, and I would like to turn the conference back over to Cetric. Friends, what for any further remarks? Thank you, operator. Thank you, everyone, for joining us this morning. 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. Thank you.
Douglas Tsao: Okay. All right. Thanks very much.
Douglas Tsao: Thank you and I'm sure as I said there is no further questions and I would like to turn the conference back over to Cedric Francois for any further remarks.
Operator: This concludes today's conference call. Thank you for participating, and you may now just connect. Thank you.
Cedric Francois: This concludes today's conference call. Thank you for participating and you may now disconnect.