Q2 2025 Apellis Pharmaceuticals Inc Earnings Call

Good day and welcome to the second quarter 2025 apellis Pharmaceuticals Inc, earnings conference call.

As Arna. Listen only.

A question and answer session.

To ask a question during the session, you will need to press star 1. 1 on your telephone. You will then hear an automated message. Advising. Your hand is raised to withdraw your question. Press star 1 1 again, please be advised. That today's conference is being recorded. I would now like to hand the conference over to your speaker, Tracy Venice, vice president of communications.

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

Please go ahead.

Good morning and thank you for joining us to discuss the pel's second quarter, 2025 Financial results with me on the call or co-founder and chief executive officer, Dr. Cedric Francois key financial officer Tim Sullivan chief medical officer Dr. Caroline Bal and Executive Vice President of commercial. David a

before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs

Cedric Francois: Thank you, Tracy. As many of you know, Appellis is a pioneering biopharmaceutical company with two approved C3 targeting medicines, cytophory and Embavili, both with drug-booster potential and a pipeline of innovative therapies. We are focused on treating diseases with high unmet needs by targeting C3, the central protein in the component cascade, and the only target that addresses all three activation pathways that can initiate and drive disease. Earlier this week, the FDA approved a label expansion for Embavili for the treatment of patients 12 years and older with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis. This marks our third FDA approval in just four years, a significant milestone that reflects the strength of our science and our ability to deliver for patients.

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 details. Now, I'll turn the call over to Cedric.

Thank you, Tracy.

many of, you know,

this is a

bioer the Google company with 2 approved C3 targeting medicines safe ovary and both of your potentials and the pipeline of innovative Therapies.

3, the central protein in the complement Cascade and the only targets that addresses all 3 activations Pathways that can initiate and strive disease.

Earlier this week.

Cedric Francois: Importantly, this approval represents a breakthrough for patients as, for the first time, they can be treated with a C3 targeting therapy and one that achieves the trifecta of outcomes across all three key markers of these diseases, including proteinuria reduction, EGFR stabilization, and substantial clearance of C3 deposits. It also advances care for several underserved populations that previously had no approved treatments, including pediatric patients with C3G, primary ICMP gen patients 12 years and older, and patients with post-transplant C3G disease recurrence. The launch is now underway, and we are excited to make this transformative medicine available to patients as we expand into rare nephrology. Moving then to cytophory performance, we continued to see steady demand growth in the second quarter. Total injections, including commercial and free goods, grew by 6% quarter over quarter, delivering cytophory revenues of $151 million.

The FDA approved. A label extension for empathy for the treatment of patients, 12 years and older with C3 inflammatory or primary immune complexion and Brandon proliferative. Glome Fus, this marks our third FDA approval in Just 4 years. The significant Milestone, that we Flex the strength of our science and our ability to deliver for patients,

Importantly, this approval represents a breakthrough for patients as for the first time they can be treated with a C3 targeting therapy and 1 that achieves the trifecta of outcomes across all. 3 key markers of these diseases including proteinuria reduction, egfr stabilization and substantial clearance of c3d deposits.

It also advances care for several underserved populations. That previously had no approved treatments including pediatric patients with c3g.

Primary, icmp, Jim patients, 12 years and older and patients with post transplant c3g disease. Recurrence,

The launch is now underway and we are excited to make this transformative medicine available to patients as we expand into rare neurology.

Moving them to safer, reperformance.

We continued to see steady demand growth in the second quarter.

Cedric Francois: Cytophory remains the clear market leader in GA, with 55% of new patient starts during the quarter and total market share exceeding 60%. Conventionally, with the headwinds we saw in the first quarter, we do continue to see high levels of free goods usage in connection with the funding shortage at the co-pay assistance programs. The market opportunity in GA is significant. With cytophory's market leadership, strong patent life, meaningful potential for growth, and a low likelihood of new market entrants in the next few years, we have confidence in the long-term potential of cytophory. During the second quarter, we also gained significant operational flexibility through our Astavelli cap royalty purchase agreement with SOAP. This transaction reflects our shared confidence in the meaningful growth potential in rare kidney diseases.

Total injections, including commercial and free goods, grew by 6% quarter over quarter, delivering site revenues of $151 million.

Cycle Remains the clear market leader in GA with 55% of new patients starts during the quarter and total market share exceeding. 60%.

Comments with the headwinds we saw in the first quarter, we do continue to see high levels of 3. Good usage in connection with the funding shortage at the co-pay assistance programs.

The market opportunity in GA is significant.

Would say 4 weeks Market leadership, strong patent life, meaningful potential for growth and a low likelihood of New Market entrance in the next few years, we have confidence in the long-term potential of cycle rate.

During the second quarter, we also gained significant operational. Flexibility through our ASA Deli cap. Royalty purchase agreement with. So

Cedric Francois: With a strong cash position, a substantial growth opportunity for Embavili, cytophory's continued market leadership, and a maturing pipeline, we are well positioned for success going forward. With that, I will now turn over the call to Tim to provide a review of the financials from the second quarter. Tim?

This transaction, reflects our shared components in the meaningful growth potential in rare, could be diseases.

With a strong cash position to substantial growth opportunity. For empathetic cyber risk, continues Market leadership, and a maturing pipeline. We are well positioned for Success going forward.

David Acheson: Thank you, Cedric. Total revenue for the second quarter was $178 million, including cytophory net product revenue of $151 million. Utilization of cytophory free goods remained high during the second quarter and impacted revenue by approximately $13 million. We expect a similar impact to quarterly revenue throughout the rest of 2025. We delivered over 95,000 doses of cytophory in the quarter, including 82,000 commercial doses and 13,000 free goods doses. Cytophory injection demand grew 6% during the quarter. Looking ahead to the rest of the calendar year, we expect quarter over quarter injection growth to be in the low to mid-single digits, consistent with the growth trajectory of the last two quarters. Over the longer term, we aim to accelerate growth with several key initiatives that David will speak to shortly. Embavili continues to elevate the standard of care in PNH.

With that, I will now turn over the call to Tim to provide a review of the financials from the second quarter. Tim

thank you, Cedric.

Total revenue for the second quarter was 178 million including ciphering, net product, revenue of 151 million.

Utilization of Cypher over the free Goods, remained High during the second quarter and impacted Revenue by approximately 13 million.

We expect a similar impact to quarterly Revenue throughout the rest of 2025.

We delivered over 95,000 doses of Cipher in the quarter including 82,000 commercial Doses, and 13,000 free Goods doses.

For re injection demand grew 6% during the quarter. Looking ahead to the rest of the calendar year, we expect quarter over quarter injection growth to be in the low to mid single digits consistent with the growth trajectory of the last 2 quarters.

Over the longer term, we aim to accelerate growth with several key initiatives that David will speak to shortly.

David Acheson: Revenue in the second quarter was $21 million, up 5% quarter over quarter. Patient compliance rates remained at 97%. We expect Embavili to begin generating meaningful revenue from the C3G and primary ICMP gen opportunities in the fourth quarter of 2025. Turning now to the cap royalty purchase agreement with Sobey, this transaction reflects both parties' shared confidence in the blockbuster potential of this product. In exchange for 90% of future ex-US Aspavelli royalties up to the cap, Appellis received a $275 million cash payment upfront. Appellis is also eligible to receive $25 million in milestones upon their European Medicines Agency approval of Aspavelli in C3G and primary ICMP gen. Defined caps tied to Aspavelli's performance allow Appellis to participate in long-term upside. Once these caps are achieved, all royalties refer to Appellis. These deal terms provide validation of the potential for meaningful growth in C3G and primary ICMP gen.

Ma Valley continues to elevate the standard of care in P&H Revenue. In the second quarter was 21 million up 5% quarter over quarter.

Patient compliance rates remained at 97%.

We expect empaveli to begin generating, meaningful revenue from the c3g and primary mpgn opportunities in the fourth quarter of 2025

turning now to the cap. Royalty purchase agreement, with soby, this transaction reflects both parties, shared confidence in the Blockbuster, potential of this product.

In exchange for 90% of future ex us as pavell royalties up to the cap.

A palace received a 275 million cash payment upfront.

Tell us is also eligible to receive 25 million in Milestones upon their European, medicines agency, approval of aspect Valley in c3g and primary icmp PGM.

Participate in long-term upside.

once these caps are achieved all royalties refer to a palace,

David Acheson: This purchase agreement does not affect the regulatory and commercial milestones Appellis is eligible to receive under our 2020 agreement with Sobey. We have maintained a highly disciplined approach to cost management while prioritizing the commercialization of cytophory and Embavili. Operating expenses were $212 million in the second quarter versus $229 million in the second quarter of 2024. We continue to expect our 2025 operating expenses to be in line with 2024 OPEX. We ended the quarter with $370 million in cash and cash equivalents. We expect this cash, combined with the $275 million payment from the royalty purchase transaction and future product sales, will be sufficient to fund the business to sustainable profitability. I will now hand the call over to Caroline for an update on our medical activities. Caroline?

these deal terms provide validation of the potential for Meaningful growth in c3g and primary mpgn.

This purchase agreements is not affect the Regulatory and Commercial Milestones of palaces eligible to receive under a 2020 agreement with SoBe.

We have maintained a highly disciplined approach to cost management while prioritizing the commercialization of cipo and EPO Valley.

Operating expenses were 212 million in the second quarter versus 229 million in the second quarter of 2024.

We continue to expect our 2025 operating expenses to be in line with 2024 Opex.

We ended the quarter with 370 million in cash and cash equivalents.

We expect this cash combined with the 275 million payment from the royalty purchase transaction. And future products, sales will be sufficient to fund the business to sustainable profitability.

Caroline Baumal: Thanks, Tim. With cytophory as the leader in geographic atrophy and three diseases now approved for treatment with Embavili, we have validated our conviction in targeting C3 as the optimal way to control complement-neviated diseases. With the launch underway in C3G and primary ICMP gen, we are planning the next phase of our strategy to maximize the potential of Embavili. With a proven ability to control complements retargeting C3, we are expanding Embavili development into two other rare kidney diseases: delayed graft function, or DGF, and primary focal segmental glomerulosclerosis, FSGF. Similar to C3G, FSGF is a rare kidney disease that progresses to kidney failure within 5 to 10 years for about half of patients. DGF is a complication in kidney transplantation where the transplanted kidney fails. Most patients are forced to go onto dialysis, which negatively affects the long-term survival of the kidney and overall patient outcomes.

I will now hand the call over to Caroline for an update on our medical activities, Caroline.

Thanks Tim with safe ovary as the leader in Geographic, atrophy and 3 diseases. Now approved for treatment with a valley, we have validated our convictions in targeting C3 as the optimal way to control compliment mediated diseases,

With the log underway and c3g and primary IC. Mpgn we are planning the next phase of our strategy to maximize the potential event for Valley

With a proven ability to control compliments through targeting C3. We are expanding and for Valley development, into 2, other rare kidney diseases, delay, graph function, or dgf.

And primary focal segmental gloss, spos.

Similar to C3G, FSGS is a rare kidney disease that progresses to kidney failure within 5 to 10 years in about half of patients.

DGF is a complication in kidney transplantation, where the transplanted kidney fails.

Caroline Baumal: The complement pathway plays a significant role in both diseases, and there are currently no FDA-approved therapies for either. We remain on track to begin pivotal trials in DGF and FSGF by the end of the year. We are also focused on the development of a next-generation treatment for geographic atrophy. I'm pleased to share that we have initiated a phase two study evaluating the combination of cytophory and our siRNA APL3007. With APL3007's ability to lower complement levels systemically and cytophory's well-established ability to inhibit complements in the retina, we believe we can improve efficacy with fewer injections. I look forward to sharing more on our exciting progress in the coming quarters. I'll now turn the call over to our Executive Vice President of Commercial, David Acheson.

Most patients are forced to go onto dialysis, which negatively affects the long-term survival of the kidney and overall patient outcomes.

The complement pathway plays a significant role in both diseases and there are currently no FDA approved therapies for either.

We remain on track to begin pivotal, trials in dgs and fsgs by the end of the year.

We are also focused on the development of a Next Generation treatment for Geographic, atrophy.

I'm pleased to share that. We have initiated a phase 2 study, evaluating the combination of pipoy and our SI RNA, ATL 3007.

With APL, 3007 ability to lower complement levels systemically and pipo Ruiz. Well established the ability to inhibit compliments in the retina. We believe we can improve efficacy with fewer injections.

I look forward to sharing more on our exciting progress in the coming quarters.

David Acheson: Thank you, Caroline, and good morning, everyone. Following approval and the outstanding broad label we received from the FDA, I'd like to start with Embavili and the launch into C3G and primary ICMP gen. The initial response has been gratifying, and we have already seen activity from both patients and the treatment community. In the US, we estimate there are approximately 5,000 C3G and primary ICMP gen patients. Notably, Embavili's broad label makes it the first treatment approved for pediatric patients with C3G, primary ICMP gen patients aged 12 years and older, and patients with post-transplant C3G disease recurrence. We expect Embavili to become the preferred treatment option across all C3G and primary ICMP gen patients on its way to blockbuster status.

I'll now turn the call over to our Executive Vice President of commercial. David a

Thank You, Caroline and good morning. Everyone following approval and the outstanding broad label will receive from the FDA. I'd like to start with a belly and the launch in c3g and primary ICM. Pgs the initial response has been gratifying and we have already seen activity from both patients and the treatment community.

In the US we estimate there are approximately 5,000 c3g in primary IC. MPG and patience notably and pavil Broad label makes it the first treatment proved for Pediatric patients with c3g. Primary it MPG and patients aged 12 years in order and patients with post-transplant c3g disease. Recurrence

David Acheson: By the end of the year, we expect to transition approximately 50 C3G and ICMP gen patients who are receiving Embavili as part of our early access program, or EAP, to commercial drug. Furthermore, we know there are some patients and physicians who are awaiting the approval of Embavili that are expected to generate early demand. Beyond this, we expect traditional rare disease launch dynamics where there have historically been few or no approved treatments. More broadly, we are excited about this opportunity for growth. We are executing on three pillars to maximize the potential of Embavili in these diseases. First, raise awareness about the availability of Embavili as a disease-modifying therapy that targets the underlying cause of disease. This approval represents a breakthrough for patients, and for the first time, they can be treated with a C3 targeting therapy.

We expect at the Village to become the preferred treatment option across all c3g and primary ICM. PGN patients, on its way to Blockbuster status.

By the end of the year, we expect a transition, approximately 50 c3g and MPG and patients who are receiving EPA Valley as part of our Early Access program or EAP to commercial drugs.

Furthermore, we know there are some patients and Physicians, who are awaiting, the approval of impa valley, that are expected to generate early, demand Beyond this. We expect traditional rare disease, launch Dynamics where there have historically been few or no approved treatments.

More broadly. We are excited about this opportunity for growth. We are executing on free pillars to maximize the potential of impa in these diseases.

David Acheson: Second, our goal is to establish Embavili as the treatment of choice among nephrologists. We plan to leverage the outstanding clinical data to support this approval. Our goal is for physicians and patient communities to equate early use of Embavili with the preservation of kidney function and long-term disease control. Third, we are working to secure broad access as soon as possible. We care deeply for patients and are committed to ensuring that every patient who may benefit from Embavili has access to treatment. This includes helping patients to reimburse in processes, disease education, and product support. We have been very successful in increasing disease awareness through our strong presence in physician offices and medical conferences and look forward to updating you on our progress. Switching now to cytophory in the GA market. We are encouraged to see continued market leadership with injection growth of 6% during the quarter.

Targets the underlying cause of disease, this approval represents a breakthrough for patients and for the first time they can be treated with a C3 targeting therapy.

Second, our goal is to establish and Prevail as the treatment of choice among neurologists. We plan to leverage the outstanding clinical data that supported this approval. Our goal is for Physicians and patient communities to equate early use of empaveli with the preservation of kidney function and long-term Disease Control.

Third, we are working to secure broad access as soon as possible. We care deeply for patients and our committed to ensuring that every patient who may benefit from EPA Valley has access to treatment this includes helping patients to reimburse. The processes disease, education and product support

We have been very successful in creating disease, awareness, through our strong presence in physician offices and medical conferences. And look forward to updating you on our progress.

David Acheson: However, revenue continued to be impacted by elevated use of free goods. We are working closely with the red offices to educate on best practices for managing patient access and reimbursement processes. As Tim already mentioned, our expectation for the rest of 2025 is for low to mid-single-digit injection growth, consistent with the growth we've seen in the first half of this year. Now moving to our key strategic objectives: growing the GA market and maintaining our leadership. Last quarter, I talked about some of our field initiatives to drive demand and new patient starts. We'll continue to execute on these. Disease awareness education on the importance of treating GA early and effectively remains a major focus for us. Many retina specialists take a wait-and-see approach when treating GA patients. There is a disconnect between physician perceptions of GA and the functional impact patients experience.

Switching out aside for every and the ga Market, we are encouraged to see continued Market leadership with injection growth of 6% during the quarter.

However, Revenue continued to be impacted by elevated. Use of free Goods. We are working closely with red offices to educate, on best practices for managing, patient access, and reimbursement processes.

As Tim already mentioned, our expectation, for the rest of 2025 is for low to mid single-digit injection growth consistent with the growth we've seen in the first half of this year.

Now, moving to our key, strategic objectives, growing the ga market and maintaining our leadership.

David Acheson: We're working to close this gap. Next, we are expanding our engagement within the clinical community to educate the optometrists and ophthalmologists who manage a significant proportion of patients. We have prioritized engaging with these physicians to raise awareness about GA and the benefits of cytophory treatment. Our efforts include directing them to our physician finder tool, which provides a list of retina specialists who have recently had experience using cytophory. Finally, we continue to leverage our highly successful DTC campaign to secure awareness and activate the patient base to seek treatment. Turning to competitive dynamics and our continued market leadership, cytophory is the clear market leader by any measurable metric: revenue, new patient share, overall market share, commercial vials, total injections, preferred payer coverage, and presence at academic conferences. Our gains on new patient share reflect an understanding of cytophory's differentiated profile.

Last quarter, I talked about some of our field initiatives to drive the man. A new patient starts with continued to execute on these disease awareness education on the importance of treating GA early and effectively remains a major Focus for us many Retina Specialists take a wait and see approach. When treating GA patients there is a disconnect between position perceptions of GA and the functional impact patients experience. We're working to close this Gap.

Next, we are expanding our engagement within the clinical Community to educate the optometrist and ophthalmologist to manage a significant proportion of patients.

we have prioritized engaging with these Physicians to raise awareness about GA and the benefits of CYO retreatment,

Our efforts include directing them to our position finder tool, which provides a list of Brea Specialists, who have recently had experienced using sex over it.

Finally, we continue to leverage our highly successful DTC campaign to secure awareness and activating the patient base to seek treatment.

Turning to competitive Dynamics and our continued Market leadership. Scip. Ovary is the clear market leader by Andy, measurable metric, Revenue new patient, share overall market, share commercial vials, total injections, preferred payer coverage and Presence at academic conferences.

David Acheson: Specifically, cytophory is the only GA product to demonstrate robust and increasing effects over time. Cytophory is the only GA product approved for a few of six doses per year. Cytophory is the only product in a preferred position with many payers. And finally, we have five outstanding data presentations at the ASRS conference this week. We expect this newly published data on cytophory's unique ability to preserve retina tissue over time to further differentiate cytophory and build on our market leadership. I look forward to reporting on our progress on our third quarter call. Let me now turn the call back to Cedric.

Our gains on new patients, share reflects an understanding of cycle of re differentiated profile. Specifically Cypher is the only GA product to demonstrate robust and increasing effects over time.

Cypher is the only GA product approved for as few as 6 doses per year.

Cycle over is the only product in a preferred position with many pairs. And finally, we have 5 outstanding data presentations at the asrs conferences. This week, we expect this newly published data on type over's, unique ability to preserve retina tissue over time to further differentiate sex ovary and build on our Market leadership.

Cedric Francois: Thanks, David. Before we close out the call, I'm excited to also share two key leadership appointments that mark an important new chapter for our phase. We are pleased to welcome Dr. Leslie Meltzer as our new Chief Research and Development Officer. Leslie comes to us from Orchard Therapeutics and is an experienced biopharma leader with a proven track record of advancing therapies from early-stage research through regulatory approval and commercialization. She will officially join Appellis on August 25. We also recently welcomed Kelly Boucher as our new Chief People Officer. Kelly joins us from Al-Nahlon, where she served as Chief Human Resources Officer. Over her six-year tenure, she played a pivotal role in shaping Al-Nahlon into a top-tier biotech company consistently recognized for its outstanding workplace culture. Please join me in warmly welcoming both Kelly and Leslie to the Appellis team.

I look forward to reporting on our progress. On our third quarter call, let me now, turn the call back to Cedric.

Thanks David.

before we close out the call, I'm excited to also share 2 key leadership appointments that Mark an important new chapter for evidence

We are pleased to welcome Dr. Leslie Meltzer, as our new Chief research and development officer,

Leslie comes to us, from Orchard's Therapeutics and is an experienced biofarma leader with a proven track record of advancing therapies from early stage research, through regulatory approval, and commercialization. She will officially join us for this on August 25th.

We also recently, welcome Kelly, buscher as our new Chief people officer.

Kelly joins us from Al n where she serves as Chief Human Resources officer,

Over her 6 year tenure she dated a pivotal role in shaping our Island into a top tier biotech company, consistency, recognized for its outstanding workplace culture.

Cedric Francois: The first half of 2025 has been a period of success for Appellis, and we look forward to continuing this in the second half of this year. And with that, I'll turn the call over to the operator for Q&A.

Please join me in warmly welcoming both Kelly and Leslie to the Athletics team.

The first half of 2025, has been a period of success for at least.

And we look forward to continuing this in the second half of this year.

Tracy Bennis: Thank you. As a reminder, to ask a question, you will need to press star one-one on your telephone. To withdraw your question, press star one-one again. Due to time restraints, we ask that you please limit yourself to one question. Please stand by while we compile the Q&A roster. And our first question will come from the line of John Miller with Evercore. Your line is open.

With that, I'll turn the call over to the operator for Q&A.

Ask a question, you will need to press star 1 1 on your telephone.

To withdraw, your question, press star 1 1 again, due to time restraints, we ask that you, please limit yourself to 1 question please. Stand by while we compile the Q&A roster,

David Acheson: Hi, guys. Thanks for taking my question and congrats on all the progress. I'd love to ask about the GA market since we just had a kidney call. But I guess your competitor is talking about 20% plus square-on-quarter growth. They're talking about majority market share as well. They confirmed that they're also using insurance claims to generate their supposedly majority market share. So I wonder if you could just help me square that circle a little bit. It feels like your growth in the mid-single digits is good, but you know that's not what they're expecting. Your market share looks great, but again, this is concordant with what they're expecting. So can you help me understand how you guys are getting to different results on the overall market potential here?

And our first question will come from the line of John Miller with Evercore. Your line is open.

Cedric Francois: Thank you so much, John. And great hearing you. So we have clear leadership, to be clear, on every single metric: on revenue, new patient share, overall market share, on vials, on injections, on preferred payer coverage, and also presence at academic conferences. I mean, we're here at the ASRS in Long Beach. We have five volume presentations. Our competitor has zero. Right? So I think it's really important to point out also that the data that is being presented is still, by now, four years old and is still the one-year data because in the second tier, you know it wasn't as good as in the first tier. So these are things that really favor us. And I think the quality of the data, especially what came out after four years of treatments in the GAIL extension with cytophory, is something that really resonates with the retina community.

Uh, hi guys. Uh, thanks for taking my question and congrats on all the progress. I'd love to ask about the GA markets as we just had a kidney call, but I guess your competitor is talking about 20% plus score on quarter growth. They're talking about a majority market share as well. They confirmed that they're using insurance claims to generate their, uh, supposedly majority market share. So, I wonder if you could just help me square that circle a little bit. Uh, it feels like your growth in the mid-single digits is good, but, uh, you know, that's not what they're expecting. Your market share looks great, but again, this is discordant with what they're expecting. So, can you help me understand how you guys are getting to different results on the overall market potential here? Thank you so much, John, and great hearing you. So we have clear leadership, to be clear, on every single metric on revenue, new patient care, overall market share on vials and injectables.

Ejections on preferred payer coverage and also present with an academic conferences. I mean, we're here at the SRS Inn in Long Beach, we have 5 boarding presentations. Our competitor has to zero, right? So I think it's

really important to point out. Also that the data that is being presented is still is by now 4 years old. And it's still the 1 year data because in the second year, um, you know, it wasn't as good as in the first year. So these are things that we need save us and I think the quality of the data, especially what came out after 4 years of treatments, um, in the Gale extension website, will read

Cedric Francois: So look, also, I think it's important to note that the way in which we track and measure the competitive dynamics is on a much larger database set than what our competitor uses. Ours is representative of approximately 50% of injections in the offices, whereas our competitor estimates their presence on approximately 10% with the database data. So I think, look, at the end of the day, it comes down to the meaningfully differentiated efficacy profile that we have that is starting to resonate with the retina community and the continued evaluation scientifically of what cytophory can do for patients. And that is really gratifying to see because, you know again, it's a full four years of data that we can analyze for cytophory with the benefit and the increasing effects over time continue to stand out.

Is something that really resonates uh, with the retina community.

So um look also I think it's important to note that the way in which we track and measure. The, the competitive Dynamics is on a much larger database set than what our competitor uses ours is representative of approximately, 50% of, uh, injections in the offices. Whereas our competitor estimates, their presence on approximately 10% with the database that they use. So I think look at the end of the day, it comes down to the the meaningfully differentiated efficacy profile that we have that is starting to resonate with the direct community and the continued evaluation scientifically on both sides before we can do for patients and that is really great at trying to see because you know again it's a full 4 years of data that we can analyze for a fully with the benefit uh and the increase in infection.

10 continue to stand up.

Tracy Bennis: Thank you. One moment for our next question. And that will come from the line of Anupan Rama with JPMorgan. Your line is open.

Thank you. 1 moment for our next question.

David Acheson: Hey, guys. Thanks so much for taking the question. I was wondering if you could comment a little bit more on some of the sampling trends you saw in the quarter. I know last year you said it was going to, or last quarter you said it was going to be about a similar amount. It looks like there's a little bump here on an absolute basis. So maybe just providing a little bit more color on how you're thinking about moving forward. Thanks so much.

Will come from the line of Anu Panama with JP Morgan. Your line is open.

Hey guys, thanks so much for taking the question.

Cedric Francois: Thank you, Anupam. Great hearing you. And I will hand that question over to David Acheson.

When trends you saw in the quarter, I know last year you said it was going to—our last quarter you said it was going to be about a similar amount. It looks like there's a little bump here on an absolute basis. So maybe just providing a little bit more color on how you're thinking about moving forward. Thanks so much.

David Acheson: Hey, Anupam. Thank you very much for the question. Appreciate it. As you would suspect, as we continue to grow the business quarter over quarter with the injections, we're going to continue to see some additional growth as we continue to play through the situation with the foundation funding, where we could potentially see at or close to the same level of the 13 million in samples that we saw in Q2. And that's why you have a little bit of the bump. So the business continues to grow, and the injections and the demand is there, which is very positive. And I'm very encouraged by that. As we work through the rest of this year, I think we'll see similar trends.

Thank you and great hearing you and I will hand the question over to David. Thank you very much for the question. Appreciate it. Uh as you would suspect as we continue to grow the business, um quarter of a quarter with the injections, you're going to continue to see some additional growth uh as we continue to play through the situation with the foundation funding. Um, where we'll, you know, we could potentially see uh app or you know, close to the same levels of the 13 million in in samples that we saw in Q2 and and that's why you have a little bit of the bomb. So the business continues to grow uh and then the injections and the demand is there which is very positive and I'm very encouraged by that um as we work through the rest of this year. I think we'll see some more trends.

Tracy Bennis: Thank you. One moment for our next question. And that will come from the line of Igor Nocimovic with Citigroup. Your line is open.

Thank you. 1 moment for our next question.

David Acheson: Oh, great. Thank you. I had a question on FSGS with regard to your phase three plans. As you know, there's been a lot of work regarding endpoints in FSGS, including a parasol working group that determined that proteinuria was a very good proxy for EGFR slope. I'm wondering if you can comment with respect to what your plans are on endpoints for the FSGS trial. Thank you.

And that will come from the line of ego novich with Citigroup your line is open.

Cedric Francois: Thank you so much, Igor. And thank you for that question. So, you know, obviously, we are going to be in the SIPS arena, if you want to call it, of the parasol group's worth. Parasol's group worth. And it's a trial we're very excited about. We're still planning to enroll or start enrollment in that trial in the second half of this year. And we believe that the mechanism, the target engagement of Embavili in the kidney, and what we can do on a differentiation basis, you know, neither should not look forward to.

Oh, great, thank you. Um, I had a question on fsgs uh, with regard to your phase 3 plans. As you know, there's been a lot of work regarding endpoints in fsgs, including a parasol working group that determined that protein area was a very good proxy for egfr slope. I'm wondering if you can comment with respect to what your plans are on endpoints for the fsgs trial. Thank you.

David Acheson: Okay. And if I could just put one follow-up regarding the free goods. In prior quarters, you'd referenced samples for cytophory. Is it fair to assume that the samples are sort of subsumed within free goods, or are they different or the same? It's a little unclear as far as the terminology now. Thank you.

Thank you so much to you guys, and thank you for that question. So, um, you know, obviously we are going to be, uh, in, in, in the slip stream if you want to call that of, um, of the parasol groups, work parasols group work and, um, to travel very excited about, uh, we're still planning to enroll or start enrollment in that trial and second half of this year. We believe that the mechanism, uh, the target engagement of in the kidney and what we can do on a differentiation basis, um, you know, neither shouldn't but look forward to

Cedric Francois: Thank you, Igor. David, it's will be elaborating on that.

Okay, and if I could just put 1 follow up regarding the the free Goods in Prior quarters, you'd referenced samples for Cypher, is it fair to assume that the the samples are sort of subsumed within free Goods or are they? Different are the same. It's a little unclear as as far as the terminology now. Thank you.

David Acheson: Here you go. Thanks for the question. By the way, you're right. It's basically a terminology shift that we've made. We've included both samples and the PATH program, a patient assistance program, in free goods to capture all of the free goods that are being used in the marketplace. Okay. Thank you.

Thank you, you go, Davids. It will be that great number. There you go. Um, thanks for the question, by the way. You're right; it's basically a terminology shift that we've made. We've included, um, both samples and...

Path program or patient assistance program in Bri Goods, to capture, all the triggers that are being used in the marketplace.

Tracy Bennis: One moment for our next question. And that will come from the line of Salvine Richter with Goldman Sachs.

Okay, thank you.

1 moment for our next question.

And that will come from the line of saline rtor with Goldman Sachs.

Srinath Raman: Hi. This is Srinath Raman for Salvine. Congratulations for the quarter. So you've mentioned the expectation of Q injection growth in the low to mid-single digits. Is this a conservative estimate, and when do you expect to see an expansion for this growth rate?

Cedric Francois: Yeah. Thank you so much for that question. I think the most important aspect here to bear in mind is that we, with cytophory, we are now having a stable business with steady and gradual growth. Right? And that is something that allows us to really continue to work on the many, many patients that haven't been treated yet, continue to educate the retina community. And again, I want to point out that between the two products on the market, a little over 10% of patients have been treated so far. There's a long way to go. Most importantly, we are now in quite a stable situation, something that we look forward to taking advantage of.

Hi, this is congratulations to the quarter. Um so you've mentioned that the expectation of uh q q injection growth in the low, to mid single digits, um, is this a conservative estimate? And and when do you expect to see an expansion? Um, uh, for this growth rate?

Thank you so much for that question. I think the the most important aspect here, so there in mind is that we would say for free. We are now having a stable business with steady and gradual growth right? And that is something that um,

Allows us to really continue to work, uh, on the many, many patients that haven't been treated yet. Continue to educate the retina Community, uh, and again, I want to point out that between the 2 products on the market, a little over 10% of patients have been treated so far. Um, there's a long way to go. Uh, the most importantly, we are now in a, in a, in quite a stable situation, something that

We look forward to taking advantage of.

Srinath Raman: Thank you.

Tracy Bennis: One moment for our next question. And that will come from the line of Steve Seedhouse with Cantor. Your line is open.

Thank you.

1 moment for our next question.

Tim Sullivan: Yes. Hi. This is Timurvannikoff on for Steve. So for Q2, could you talk about the factors that drove higher cytophory revenue with similar commercial doses quarter over quarter? And also to follow up on Igor's question, out of 13,000 free injections, how many were samples for new patients versus help assistance to existing patients? Thank you.

And that will come from the line of Steve seed house with caner. Your line is open.

Yes. Hi, this is Tim morvan for Steve. So for Q2 could you talk about the factors? Uh that drove higher Cypher Revenue with similar uh commercial doses quarter quarter and and also to follow up on goes question out of 13,000 free injections. How many were samples for new patients versus help uh, assistance to to existing patients. Thank you.

David Acheson: Yeah. Thank you for the question. Appreciate it. This is David. So a couple of quick points there. So a little less than half of the growth that we saw was attributed to the free goods or the samples. So that's specific data that we can pull on our previous program. When it comes to the growth or the, I guess, the first part of your question around sample usage and where that played out up against the quarter over quarter kind of the growth that we saw overall, obviously, we've got great demand and thrilled with that and continue to see quarter over quarter growth. And samples is a part of that. So yes, we saw a trend that was pretty consistent between the commercial and trade vials, but we're also seeing true demand and patients getting started on the product through our sampling and our PATH programs.

Yeah, thank you for the question. Appreciate it. This is David. So, a couple quick, uh, points there. So, a little less than half of the growth that we saw, uh, was attributed to the previous of the samples. Um, so that's a specific data that we can pull out of our previous program. Um, when it comes to the, um, the growth or the, the, I guess, the, the first part of your question around, uh, sample usage in, where that played out up against the board order reporter kind of, um, the growth that we saw overall, uh, obviously we've got great demands been thrilled with that and continue to see forward our report of growth, um, and samples as a part of that. So yes, we saw the trend that was pretty, um, was consistent between the commercial and trade vials, uh, but we're also seeing through demand

And patients getting started on the product, um, through our sample and and our path programs.

Tracy Bennis: And one moment for our next question. And that will come from the line of Colleen Cusey with Baird. Your line is open.

And 1 moment for our next question.

Joe: Great. Thanks. Good morning. Thanks for taking my question. Just on the ongoing disruption of the third-party co-pay assistance, is there anything that you're hearing on that and any expectations on that in the near future? And then maybe one longer-term question, if I can. For the Vail long-term extension study for C3G ICMP gen, obviously, we've seen some good data from Gail that's helped us understand the differentiation of cytophory. Any expectations for the Vail data going forward and how that might differentiate Embavili in C3G and ICMP gen? Thank you.

And that will come from the line of calling QC, with beard. Your line is open.

Cedric Francois: Yeah. Thank you so much, Colleen. So look, there are evolving things happening at the foundation level for us. The way we think about these organizations is they are wonderful for patients, of course. We have supported them in the past, and we will continue to support them. So that is something that we are obviously very much in favor of. Then, as it relates to the second part of your question on, could you repeat that because I couldn't really hear it on ICMP gen?

Great. Thanks. Good morning. Thanks for taking my question, uh, just on the ongoing disruption of the third-party co-pay assistance. Is there anything that you're hearing on that and any expectations on that in the near future and then maybe 1 longer term question if I can, um, for the veil. Uh, long-term extension study for c3g IC and PGN. Obviously, we just need some good data from Gail, that's helped us. Um, understand the differentiation of sex ovary any expectations for the veil data going forward and how that might differentiate a pavilion c3g and icmp. Thank you.

Joe: Sorry. Just on the Vail data, anything we can expect from that on how that will differentiate Embavili versus its competitor in C3G ICMP gen?

At the foundation, level for us. The way we think about these organizations is they are wonderful corporations. Of course, uh, we have supported them in the past and we will continue to support them. So that is something that, um, you know, we we are obviously very much in favor of uh, and then as we get into the second part of your question on, could you repeat that because economically the year,

Cedric Francois: Thank you. I will hand it over to Caroline. Thank you, Colleen.

Sorry just unavailable data. Anything we can expect from that on how to how that will differentiate, um, the value versus its competitor in C3, GIC and BGN.

Caroline Baumal: Thanks, Colleen. Well, we got we are really thrilled with what we've seen for Embavili and the recent approval and label for C3G and ICMP gen. And I think what really differentiates us is that we achieved this trifecta of positive outcomes across these three key disease markers: reduced proteinuria, EGFR stabilization, and this robust, substantial clearance of C3 deposits in the kidney. And what we're really excited about is that these effects continued onto the Vail extension study, which, of course, rise with Gail, which is what we use for ophthalmology. But so we continue to see these effects. And even more importantly, physicians are so excited about this data. We're hearing a lot of positive input from them. Thanks, Colleen.

Thank you. I will hand it over to Caroline. Thank you. Thank you Colleen. Um, well, we got, um, uh, we are really thrilled with what we've seen for Evelyn, and the recent approval and label for c3g and icmp PGN, and I think what really differentiates us is that we achieve this Trifecta of positive outcomes across the 3, key disease markers, reduce proteinuria, egfr stabilization and the uh, robust substantial clearance of C3, deposits in the kidney. And what we're really excited about is that these effects continued onto the veil extension study? Which of course were, you know, rhymes with scale, which is what we use for opthamology. But, um, so we continue to see these effects and even more importantly, Physicians are so excited about this data, we're hearing a lot of positive

Positive, uh, uh, input from them.

Thanks calling.

Tracy Bennis: And one moment for our next question. And that will come from the line of Akash Tawari with Jeffries. Your line is open.

And 1 moment for our next question.

Kathy: Hi. This is Kathy on for Akash. Given the current cytophory trajectory, as of now, it seems like the class isn't expanding into a broader community center setting. So what's the right amount of opex spend for the GA franchise going forward? And given the current business trajectory, when do you think cytophory will reach profitability? Thank you.

And that will come from the line of Akash Tewari. With Jeffrey, your line is open.

Cedric Francois: Thank you so much for that question. I will hand that over to David.

Hi. This is Kathy on for AOS, given the current fifo re trajectory. As of now, it seems like the class isn't expanding into a broader Community Center setting. So what's the right amount of object? Spend for the J frame forward and given the current business trajectory. When do you think cyber will reach profitability? Thank you.

David Acheson: Yeah. So look, I will tell you, and I think we just need to take a step back for a second and remind ourselves how big this market is and the potential opportunities to meet a lot of unmet needs for a lot of patients that live with GA today. So I think it's important to keep that in note. I also think it's super important to go back to what Cedric just talked about. We believe we are now in a very stable market, and we anticipate that we'll have stable, steady, gradual growth. And you know right now, we've got about 10-plus percent of the market that's currently treated. So the market opportunity still exists. And we think long-term, this is still a blockbuster product in the space.

Tim Sullivan: Hey, David. This is Tim Sullivan. I'll just jump in for one second. Cytophory is one of our business lines. So we have, obviously, Embavili. We have development. We have discovery. If you're looking for whether or not cytophory alone is profitable, on its own, it's a very profitable business. It's high leverage with a reasonable sales force. And you can also see in our 10-Q, we do show on an R&D basis what is allocated to GNA. So you can make yours, you know, you can make a P&L for cytophory alone that shows it's a profitable business.

Thank you so much for that question. I will hand it over to you today. Uh, yeah. So look, I, I will tell you and I think it would just need to take a step back for a second and, and remind ourselves how big this Market is. Um, and the potential opportunities that to meet a lot of unmet needs for a lot of patients that live with GA today. So I think it's important to keep that in note. I also think it's super important to to go back to what? Senator just talked about. We believe we are now on a very stable Market, um, and we anticipate that what we have, uh, stable, steady, gradual growth, um, and, you know, right now we've got about 10 plus percent of the market that's currently treated. So, the market opportunity still exists and we think long term, uh, this is still a blockbuster product in the space.

Hey, David, this is Tim s. I'll just jump in for 1 second. Um, you know, so forever is 1 of our business lines. So we have obviously a belly, we have development, we have Discovery if you're looking for whether or not is profitable, um, on its own, it's a very profitable profitable business. It's, um, you know, High leverage, High leverage with

You know a reasonable sales force and you can also see in our 10 Q. We we we do show on an R&D basis. What is allocated to GMA so you can make yours, you know, you can make a p&l for CYO alone that shows it's it's it's a profitable business.

Srinath Raman: Thank you.

Tracy Bennis: And one moment for our next question. And that will come from the line of Divya Rao with TD Cowan. Your line is open.

Thank you.

And 1 moment for our next question.

Kathy: Hi, team. This is Divya on for Still. Based on your discussions with physicians, I'm curious if you get the sense that the competitor label expansion in February has impacted prescribing patterns now that we have about like one full quarter with the new label. And then, if I can, a quick one on Embavili. What might be the specific launch metrics we can expect for the launch in C3G over the next few quarters?

and that will come from the line of Divya Ralph with TD Cowen, your line is open,

Hi team. This is Dia on for Phil. Um,

Cedric Francois: Thank you so much for that question. I will briefly comment on our competitor's CRL and the removal in February. And then I will hand the second part of your question over to David. So I think the most important aspect of the CRL that was issued to our competitor in November is the fact that it kind of truly called out the fact that there was a limitation on that initial label of one year, something that a lot of physicians were not aware of. And then the fact that every other month, dosing was reviewed by the FDA as a treatment that works for this product. So I think that in terms of reputation, this was very important for retina specialists to understand and know. And from all the data that we see, that is not something that they have recovered from.

Based on your discussions with Physicians, I'm curious, if you get the sense that the, the competitor or label expansion in February, has impacted. Prescribing patterns. Now that we have about, like 1 full quarter with the new label. Um and then if I can a quick 1 on empa Valley um what might be the specific launch metrics? We can expect for the launch in c3g. Over the next few quarters.

Thank you so much for that question. I will briefly comment on our competitors uh, crl and the removal and February and then I will end the second part of your question, over to David.

So, I think the most important aspects of the crl that was issued to our competitor. In November is the fact that

Cedric Francois: Caroline, I don't know if she wants to expand on that.

Caroline Baumal: Just adding that we have a very cytophory has a flexible label with every other month dosing, which has been well studied in our clinical study as well as in our extension study. And we're currently at ASRS with five podium presentations. And we will continue to have robust data that data-driven retina physicians really need to treat their patients best. And all of this has helped with patient compliance. Treating them every other month is much more reasonable, and this really speaks to the broadness of cytophory use.

Understand and know and from all the data that we see that is not something that they have recovered from, uh, Caroline. I don't know if she wants to expand on that.

Uh, just

Cedric Francois: Thank you. David, do you want to comment?

Adding that we have a very effective, it has a flexible label with every other month dosing which has been well studied in our clinical study, as well as in our extension study and we're currently at SRS with 5 Podium presentations and we will continue to have robust data that data driven retina Physicians, really need to treat their patients best. And all of this has um helped uh with patient compliance, treating them, every other month, it's much more reasonable. And uh this really speaks to um the broadness of Life over use

David Acheson: Can you repeat the second part of your question? I think it was on C3G.

Kathy: Yeah. I was just curious if there was any specific launch metrics we can expect over the next few quarters on just how the launch is going for Embavili.

Thank you, David. If you want to comment, can you repeat the second part of your question? I think it was on c3g.

David Acheson: Yeah. No. Great question. Thank you for that. So our specific focus and what we'll lay out for you will be the transition that we've got for our EIP patients, which is in motion already as of this week in our in our compassionate use patients. And then we will look at star forms. That'll be where we spend our time reporting out. And then also REMS. We'll work through REMS enrollments on the physician side. Over time, what we'd like to do is transition it over to actually patients on the product. But it's early, right? It's we're three days post the awesome label coming out from the FDA. And it's going to take us a little time to get active data coming in that we can continue to track and be consistent with.

Yeah, I was just curious if there was any specific launch metrics. We can expect um over the next few Quarters on just how the launch is going for empathy. Yeah, no great question. Thank you for that. So, our specific focus and we'll lay out for you will be the transition that we've got for our EAP patients, which is in motion already. As of this week in our in our professional use patients. And then um we will look at star forms that'll be where we spend our time uh reporting out. And then also revs we'll we'll work through Rems enrollments on the physician side over time. What we'd like to do is transition it over to Jack.

David Acheson: So we want to make sure we give it a little time before we do that.

With patients on contact but it's early, right? It's you know we're 3 days post an awesome label coming out from the FDA um and it's going to take us a little time to to get um active uh data coming in that we can continue to track and be

Kathy: Thank you.

consistent with. So we want to make sure we get a little time before we do that.

Tracy Bennis: One moment for our next question. And that will come from the line of Eliana Merle with UBS. Your line is open.

Thank you.

1 moment for our next question.

Jasmine: Hi. This is Jasmine on for Eli. Thank you for taking our question. So I wanted to follow up on the patient assistance funding dynamics going forward. Specifically, can you talk about what you expect from the impact of Regeneron donation matching to Good Days? Do you think that seeing some funding return can potentially lower the usage of free drug that you see in the coming quarters? And then just secondly, can you talk about the latest you're seeing in compliance and adherence for cytophory?

And that will come from the line of Eliana, Merl with UBS. Your line is open.

Cedric Francois: Yes. Thank you so much for that question. So look, on the foundations, again, I think the most important element there, as I mentioned earlier, is that this is something that is important for patients. The way in which they manage their money, the way in which it gets allocated, the way in which it does get funded is something that we are completely independent from. For us, it's a medical decision to help and assist these foundations to help patients. So we have done that in the past. We will continue to do that. As far as compliance is concerned, I will hand that question over to Caroline.

Hi. This is Jasmine on for Led, thank you for taking our questions. So I wanted to follow up on the patient assistance funding Dynamics, going forward. Um, specifically, can you talk about what you expect from the impact of the regeneron donation matching to good days? Do you think that being some funding return could potentially lower the usage of free drive that you see in the coming quarters? And then, uh, just secondly, can you talk about the latest you're seeing in compliance and adherence for type?

Yes, thank you so much for that question. So, look on the foundations again. I think the most important element there as I mentioned earlier, is that, this is something that is important for patients, um, the the way in which they manage their money, uh,

Language, it gets allocated. The language. Those get funded is something that we

Are completely independent, from course. It's a medical decision, uh, to help and assist these foundations health patients. So, uh, we have done that in the past, we will continue to do that.

Uh, as far as compliance concerns, uh, I will add that question over to Caroline.

Caroline Baumal: Thank you, Cedric. I think that, of course, there's things that might affect patient compliance, like the patient foundations. But overall, physicians from large real-world groups are reporting compliance, and it's been about 80%. Depending on which physician group, patients are motivated to be treated, especially because they experience persistent vision loss. David, do you have anything to add?

Cedric Francois: No. That's it. Thank you.

Caroline Baumal: Okay.

Jasmine: Great. Thank you.

Um, thank you, Cedric. Um, I think that, of course, there's things that might affect patients compliance like the, the patient foundations. But overall Physicians, um, from large rail work, groups are reporting compliance. And it's been about, uh, 80% depending on which position group patients, are motivated to be treated, especially because they're experienced persistent vision loss, David do you have anything to add to that? Thank you. Okay.

Tracy Bennis: One moment for our next question. And that will come from the line of Lackland Hanbury-Brown with William Blair. Your line is open.

Thank you.

1 moment for our next question.

Cedric Francois: Morning. And thanks for taking the questions. I guess, can you just talk to the progress you've made with the benefits investigation process for the patients that were previously getting assistance and obviously no longer are? I think last call you said that was maybe 20% of patients. You know, has that have you sort of been able to make a dent in in that 20% of patients, especially in light of the fact that, as was mentioned earlier, you know commercial vials are sort of flat quarter over quarter?

And that will come from the line of Lackland hanberry brown with William Blair. Your line is open.

Morning. Thanks for taking the questions. Um,

I guess, can you just talk to the progress you made with the benefit investigation process for, you know, the patients that were previously getting assistance and and obviously no longer are. I think last call you said that was maybe 20% of patients, you know, has that have you sort of been able to make a dent?

David Acheson: Yeah. Lackland, our apologies that we can't we can't really hear what you're saying. Can you repeat, please?

In in that 20% of patients um especially in life. The fact that earlier commercial files was sort of flat or over quarter. Yeah, Lackland Oracle. Is that we can't? We can't really hear what you're saying.

Cedric Francois: Sorry. Is this better?

Can you repeat please?

David Acheson: Yes. Please go ahead.

Cedric Francois: I was wondering if you could talk to the process that you've the progress that you've had with the benefits investigation for patients that previously were using co-pay support. I think you previously said that was about 20% of patients. Have you been able to make a dent in that number because the cytophory commercial vials were flat quarter over quarter?

Yes, please go ahead.

David Acheson: Okay. Thank you so much for that question. Yes. I will hand that over to David. Yeah. Great. Thank you for the question. Appreciate that. So we did report back in our earnings call for Q1 that about 20% of the market had shifted. And our patient assistance program, obviously, is being used at a higher rate. We are working through our Pills Assist program very closely with our offices, along with our reimbursement team inside the offices, to make sure that when a patient hits an out-of-pocket max, they then get moved over to trade or commercial product as soon as they are able to do that. And it's a lot of communication between our teams and the offices and the reimbursement teams inside these accounts. And yes, we can see definitely a trend where patients get transitioned over.

Property commercial vials were flat quarter over quarter.

David Acheson: But I can also tell you that the continued use of the program has been high because the funding issue is still in play. So as patients come out of their out-of-pocket max, we move them. The good thing is we're seeing quarter over quarter injection growth, and we have additional opportunities for patients to be on product. And we'll transition them over as well. I'm going to hand it over to Tim as well, just on some of the financials part of this.

Okay, thank you so much for that question. Yes, I will hand that over to David. Yeah, great, thank you for the question, appreciate that. Um, so we did, um, report back in our, uh, earnings call for q1 at about 20% of the market had shifted and, uh, our patient assistance program obviously is being used at a higher rate. Uh, we are working through our processes program, very closely with our offices, along with our reimbursement team inside the offices. To make sure that when a patient hits an out of pocket max, they then get moved over to trade or commercial product. Uh, as soon as they are able to do that and there's a lot of communication between our teams and the offices in their reimbursement teams inside these accounts. Um, and yes, we can see definitely a trend where patients get transitioned over. Um, but I can also tell you that the, you know, continued use of the program uh has been high because the funding issue is still in place. So as patients come out of their out of pocket max, we move them. Um, the good thing is we're seeing quarter of a quarter injection growth and

Tim Sullivan: Yeah. Hey, Lackland. Thank you. I just want to caution against reading too much into any given quarter on the commercial vials delivered. That's actually from the specialty distributor to the ECP offices. And there are inventory dynamics at the ECP offices that play into that. So that's why we kind of lead people to that injection growth as the true demand measure, as opposed to looking at commercial vials. That's sort of an in-between two inventory stops. So I just wanted to caution on that on any given quarter. Over time, that injection demand and the commercial vials delivered should more or less equate to each other. But on any given quarter, they're not going to be exact. So I wouldn't read too much into any particular quarter there. Thanks.

We have additional opportunities for patients to be on product, uh, and we will transition them over as well. I'm going to hand over to Tim as well. Um, just on some of the financial part of it.

Yeah, hey Lachlan. Thank you. I just want to caution against reading too much into any given quarter on the commercial vials delivered. That's actually from the specialty distributor to the ECP offices and their inventory dynamics at the ECP offices that planned that. So, that's why we kind of lead people to that injection growth as the true demand measure as opposed to looking at commercial vials that are sort of in between two inventory stops. Just wanted to caution on that on any given quarter over time.

That injection demand and the commercial vials delivered, should more or less equate to each other but On Any Given quarter they're not going to be exact. So so I wouldn't read too much into any any particular quarter there. Thanks.

Cedric Francois: Thanks.

Tracy Bennis: And one moment for our next question. That will come from the line of Annabelle Samimi with Stifle. Your line is open.

And 1 moment for our next question.

Kathy: Hi, guys. Thanks for taking the question. Just for cytophory again, you mentioned several times the market is about 10%, I guess 10 or 15 percent penetrated, depending on whose numbers you rely on. Do you have a sense now, with the education of ophthalmologists and optometrists, on what the total penetration could be of the market? I think it's still a set goal of about 35% of the target population by 2029. Does that seem realistic based on what you're hearing back from the community? And I guess, separately on the funding gap, are there do you know of patients who are holding off starting treatment because of this funding gap, or most of these patients who need treatment are getting free goods? Thanks.

That will come from the line of Annabelle, samimi with stifle. Your line is open.

Um, hi guys. Thanks for taking the question. Um, just for stuff over again. Um, you mentioned several times in the market is about 10%, I guess, I guess 10 or 15% penetrated depending on whose numbers. You rely on. Do you have a sense now um with the education of ophthalmologists and optometrists on what the total penetration could be of the market? I think is so set a goal of about 35% of the target population by 2029. Does that seem realistic based on what you're hearing back from the community? And I guess separately on on the funding Gap are there? Do you know of

Cedric Francois: Thank you so much. So what I will say about kind of the growth beyond the, you know, a little more than 10% where we currently are is that if you take physicians that, you know, have adopted cytophory as part of their routine practice, they end up treating, you know, between 30 and 50 percent of their GA population with cytophory. So that is the, you know, on a broad basis, that is probably the type that you should be looking at in terms of what population really benefits from this product, the more you should be looking forward to. As it relates to the funding gap, I will hand that over to Caroline for comments.

Patients who are holding off starting treatment um because of this funding Gap, or most of these patients who need treatment are getting um free Goods. Thanks.

Caroline Baumal: Thank you, Cedric. You know, as someone who is still a practicing ophthalmologist, you know, we see this that patients are not able to start on treatment because of the funding gap. You know, starting patients on cytophory is not just a one-time thing. It's signing up for, you know, every four to eight weeks injections and having a long-term plan. So, you know, it's unfortunate that this is affecting patients who need this treatment. And while some patients are able to compensate for that, others are not. So resolution, I think, will be very helpful for patients. The other thing I want to say is that this is a really dynamic market, and the retina practice in the United States is very dynamic. There's constantly new patients. There's constantly new retina physicians, new ophthalmologists, new types of eye care providers.

Thank you so much. So what I will say about kind of the growth beyond the, you know, a little more than 10% where we currently are, is that if you take Physicians that, you know, have adopted Cypher as part of their routine practice. Uh, they end up treating, you know, between 30 and 50% on energy population um with with Type 4. So that is the, you know, uh, on a broad basis that is probably the type that you should be looking at in terms of what, uh, population reading benefits from this product and what we should be looking forward to, uh, as it relates to the funding Gap. I will hand that over to Caroline to comment.

Um, thank you Cedric. You know as someone who uh is still practicing opthalmologist uh you know, we we see this. That patients are not able to start on treatment because of the funding Gap. You know what starting patient onsite program is not just a 1 time thing. It's signing up for you know every 4 to 8 weeks injections and having a long-term plan. So um you know it's unfortunate that this is affecting patients who need this treatment along, some patients are able to compensate for that, others are not. So uh resolution I think will be very helpful for patients. The other thing

Caroline Baumal: And our process of doing medical education and education on GA is continuous so physicians understand how to use this medication. And one of our key highlights at the ASRS meeting is showing the 48-month Gail data. And this really attests to the fact that there are increasing effects over time. And our key point here is that earlier treatments lead to more retina tissue saved. And it's significant in the amount of the best-treated group of up to over 3 millimeters squared of retina tissue. That is about one and a half disc areas of tissue. And just so you know, that's about the size of the fovea. So we show this image to, you know, our eye care providers, and they're really impressed with how significant it is. Thank you.

Let me tissue saved and it's significant in the amount of the best treated group of up to uh over 3 millimeters squared of retina tissue. That is about 1 and a half disc areas of tissue and just so you know, that's about the size of the phobia. So we show this image to, you know, uh,

Kathy: Great. Thank you.

Our Eye Care Providers and uh, they're really impressed with how significant it is.

Tracy Bennis: One moment for our next question. And that will come from the line of Byron Amin with Piper Sandler. Your line is open.

Thank you, great. Thank you.

1 moment for our next question.

David Acheson: Yeah. Hi, guys. Thanks for taking my questions. Maybe to start on cytophory, commercial doses, I think, in the quarter were 82,000 vials. But this number was a lot higher in Q4, which is around, I think, 89,000 commercial doses. So about a decline of about 9% from Q4. Is that due to conversion to free samples, or are you seeing patient discontinuations from current patients with new patient starts predominantly going to free samples? So that's the first question. And the second question, R&D expenses came in lighter. Should we expect the Q2 run rate going forward, or should we assume the average over the last several quarters, which is around the low 80s? So thanks for that.

And that will come from the line of Byron. Am mean with Piper Sandler. Your line is open.

Yeah. Hi guys, thanks for taking my questions. Maybe to start on psycho ovary, um, commercial doses, I think in the quarter or 82,000, uh, vials. But this number was, um, a lot higher in Q4 which is around. I think 89,000 commercial, uh, doses. So about a decline of about 9% from Q4.

Is that due to conversion, uh, to free samples. Or are you seeing patient just continuation from current patients with new patient starts? Predominantly going to free samples. So, that's the first question and the second question R&D expenses came in lighter, um, should we expect the Q2 run rate going forward? Or should we assume the average over the last several quarters which is around the low 80s? Um,

Tim Sullivan: Hey, Byrne. Thanks. Yeah, for the question. This is Tim. So in the fourth quarter, as you know, there was a bit of a build. And again, the vials delivered go from the specialty distributor to the ECP. And as we talked about in the fourth quarter, there was a lot of stocking at the ECP level. So the fourth quarter, unfortunately, is really not a good barometer for looking at growth or change over time. There are a lot of inventory dynamics between the specialty distributor and the ECP fridges that we, you know, that tracks. And again, sort of to my prior comment, over time, that should average out to what the injection growth looks like. In any given quarter, it can be misleading, as it, you know, even in this quarter, right? It wasn't the growth versus the first quarter didn't exactly track injections.

So, thanks for that.

Tim Sullivan: So we're hoping that'll be more normalized over time. So, you know, just a caution around that. It's a, you know, commercial vials delivered is something we talk about sort of as an industry, and we do that. But on any given quarter, I don't think it's the best measure. That's why we've talked about injections. So that's your first part. And then on your second part, you know, in the Qs, we give a pretty good table on what's happening within the R&D expense. You know, we do that on, you know, it's in, you know, the research and development expenses section of our Q. And it breaks out those expenses pretty nicely. What you'll see is that we did have a pretty decent drop in a couple of areas for this quarter, but some of those were one-time opt-ins for, you know, some collaborative stuff we've done.

Hey Baron thanks, yeah, for the questions. This is Tim so uh in the fourth quarter, as you know, there was a bit of a, a build. And again the vials delivered is goes from the specialty distributor to the ECP and as we talked about in the fourth quarter um there was a lot of stocking at the ECP level. So the fourth quarter unfortunately is really not a good barometer for looking at um, growth or change over time. Um there are a lot of inventory Dynamics between the specialty distributor and the ECP fridges that we um, you know, that that that tracks and again, sort of to my prior comment over time that should average out to what the injection growth looks like. Um, in any given quarter, it can be misleading as it, you know, even even in this quarter, right? It wasn't the growth versus the first quarter. It didn't exactly track injections. So we're hoping that'll be more normalized over time. So, um, you know, just a caution around that it's a it's a, it's a, you know, Commercial Valve is delivered, is something we talk about sort of as an industry and we do that but um, On Any Given quarter, I don't I don't think it's the best measure.

That's why we've talked about injections. Um,

So that's your first part. And then on your second part, um, you know, in the in the cues we give a pretty good table on what's happening within the R&D. Expense uh, you know, we do that on, you know, it's in uh you know, the research and development expenses section of our our queue and it breaks out those expenses. Um pretty nicely. Um, what you'll see is that we did have a, a pretty decent drop in a couple of areas. Um,

Tim Sullivan: However, you know, I like, at least for, you know, on a go-forward basis, I like the average a little bit better because we are heading into some pivotal studies that really haven't ramped up. That's the DGF study and the FSGS studies. So, you know, I think you're probably safer more in that average zone than you are taking this quarter. But obviously, we had a few things that made this quarter look a little bit more efficient from an R&D perspective. But going forward, I would use the average.

For this quarter, but some of those were 1 time, um, you know, options for, you know, some collaborative stuff, we've done. Um, however, you know, I like at least for, you know, on a go forward basis. I, I like the average a little bit better because we are heading into some pivotal studies, um, that really haven't ramped up. That's the dgf study and the fsgs studies. So, um, you know, I think you're you're probably safer more in that in that uh, average Zone than you are taking this quarter. But uh obviously we had a few things that uh, that made this quarter. Look a little bit. Um, more efficient from an R&D perspective. But going forward, I would use the average. Thanks.

Tracy Bennis: One moment for our next question. And that will come from the line of Ryan Deshner with Raymond James. Your line is open.

For our next question.

And that will come from the line of Ryan Dashner with Raymond James, your line is open.

David Acheson: Thanks for the question. Just to clarify, when you report patient star forms and REMS enrollments for Embavili in the future, will you be breaking these numbers out by specific indication, i.e., PNH, C3G, and ICMP gen? And can you also talk about what the burden will look like to obtain prior authorization for C3G and ICMP gen patients? Thanks. Hey, thanks for the question. So yes, on the metrics of the star forms that will come in, initially, we'll only report total star forms. You know, over time, we'll start to look at how the data plays out and where we're penetrating by age group and disease state and differences in indications. But upfront, it'll be star forms only. And then we'll transition over time as we get more data.

Thanks for the question. Um,

To clarify, when you report patient enrollment forms in the RIMS for Epal in the future, will you be breaking these numbers out by specific indication, IEP, and age, C3G, and ICY MPGN? And can you also talk about what the burden will look like to obtain prior authorization for C3G and MPGN patients? Thanks.

Thanks. Thanks for the question. So, yes, on the metrics of the star forms that will come in initially, we'll report total star forms, you know, over time, we'll start to look at how the data plays out and where we're penetrating by um, age group and disease, State and differences in indications. But up front, it'll be star forms. Uh, only, uh, and then we'll transition over time as we get more data.

Caroline Baumal: As for the burden of doing REMS forms, I think that, you know, in REMS certification.Our

as for the burden of of doing Rems Farms, I think that, um, you know,

Tracy Bennis: job to inform physicians about these medications so that we're aware of all the effects of them. I think that it's done with all complement inhibitor therapy. And physicians, once they do it once, they don't have to do it again. And I think that it will not be a big burden on physicians to do this. Thank you.

In rennes certifications are done to inform Physicians about these medications. So that aware of all the effects of that. I think that um,

Complement inhibitor therapy and Physicians. Once they do it, once they don't have to do it again. And I think that it will not be a big burden on Division.

To do this.

Adam Townsend: And then for the REMS enrollment of patients, STAR forms, will you be breaking down between C3G and ICM-PTM? Thanks.

Thank you.

Cedric Francois: Not initially. We won't. Everything will be just STAR forms, and then we'll break it down as we learn more and we get more data.

For, for the Rems, enrollment to patients start forms. Will you be breaking down between c3g and ICM PGN next? Not initially, we won't everything will be just start forums and then we'll break it down as we learn more, and we get more data.

Adam Townsend: Thank you very much.

David Acheson: One moment for our next question. And that will come from the line of Douglas Soe with HC Wainwright. Your line is open.

Thank you very much.

1 moment for our next question.

Caroline Baumal: Hi. Good afternoon. Thanks for taking the questions. I'm just curious, are you seeing relatively consistent utilization of free goods across all wetness specialists, or is there sort of some practices that are using it more than others based on patient mix? And so I guess, as this funding shortage exists, is there a way for you to sort of target the market a little bit more towards patients who might be able to sort of afford the the the out-of-pockets for the time being?

And that will come from the line of Douglas. So with HC Wayne Wright. Your line is open.

Hi, good afternoon. Thanks for taking the questions. I'm just curious. Are you seeing?

Cedric Francois: Yeah. Great question. Thank you. This is David. So let me answer the first part of it. So when you look at the marketplace, what I think is a really good metric to look at is the true demand, which is the growth quarter-to-quarter injections. So we should start there. And I think the part to also keep in mind is that when a physician wants to put a patient on product, they can use free goods to do that. And they're putting those patients on product through our Apellis Pharmaceuticals Inc Adam Townsend program, and we can transition them over when their out-of-pocket max is met. So I think it's important to keep that in mind. As far as the targeting part of it and how we try to make sure that we're in the right places with the right benefit design discussion, we have a reimbursement team.

Um, relatively consistent utilization of free Goods, across all wetness Specialists, or is there sort of some practices that are using it more than others based on Patient next. And so I guess as this funding shortage exists, is there a way for you to sort of Target the market a little bit more towards patients, who might be able to sort of afford the the, the the out of pockets, for the time being

Yeah, great question. Thank you. This is David. So let me uh answer the first part of it. So when you look at the marketplace uh what I think is a really good metric to look at is the true demand which is the growth quarter over quarter and injection. So we should start there. And I I think the the part to also keep in mind is that when a physician wants to put a patient on a product, they can use free Goods to do that and they're putting those patients on product through our Appel assist program and we can transition them over when they're out of pocket, max is melt. So I think it's important to keep that in mind. Um,

Cedric Francois: I also have an Apellis Pharmaceuticals Inc Adam Townsend organization that connects with these offices on a regular basis. We've had a very concerted effort in these offices to go in and educate on benefit design so that those accounts can help patients pick the right benefit in Medicare that will pay for these products even today and the family the funding issues that we've had over time, right? So we've been very close to the education on it. So we've done a lot of targeting, and I think that's helped a lot of the feedback we've gotten back from the offices. And we'll continue to do that. And over time, these patients will then transition either to a new benefit design, or they'll transition from because of out-of-pocket max to trade bios and treatment.

Caroline Baumal: And if I may, one follow-up. I'm just curious, when you know, you think about the patients that are getting treated today, I think, you know, in the past, you would refer to sort of like most, you know, like sort of just almost all of them were coming from existing wetness specialists, folks, or existing patient-based populations. Are you seeing more patients come from referrals directly? And are you seeing a shift in terms of the time from a patient's initial diagnosis of GA to start in treatment?

As far as the targeting part of it, and how we try to make sure that we're in the, the right places, with the right benefit design discussions, we have a reimbursement team. I also have an appellate of cyst organization that can connect with these offices on a regular basis. We've been, we've had a very concerted effort in these offices to go in and educate on benefit design so that those accounts can help patients pick the right benefit in Medicare. That will pay for these products, uh, even today and the family, uh, the funding issues that we've had over time, right? So we've, we've been a very, uh, close to the education on it. Um, so we've done a lot of targeting and I think that's helped a lot, but the feedback we've gotten back from the offices and we'll continue to do that. And over time, these patients will then transition, um, either to a new benefit design, or they'll transition from because of out of pocket, max to, uh, trade files and treatments

It. And if I can, if I met one follow-up, I'm just curious when, um,

Cedric Francois: Yeah. So we have a program. We've got actually a couple of programs where we've got folks that are in these offices for ophthalmology and optometry, specifically for education and specifically so patients cannot be identified and then referred to a treating retina specialist. And that has obviously been running for quite some time now. But we do see data in transition. I will tell you one thing to keep in mind. And as we move those patients over, there are still a lot of patients inside these offices where the treating injection offices and retina specialists are that could go on treatment because about 50% of the market sits in those offices already. And then the market is very large, as you know. So there's opportunities on both sides. Yes, we can see that data.

You know, you think about um, the patients that are getting treated today. I think, you know, in the past um you'd refer to sort of like most, you know, like sort of just almost all of them were coming from existing retina specialist books, or existing patient. Based populations, are you seeing more patients, come from referrals directly? And are you seeing a shift in terms of the time from of the patients initial diagnosis of GA to start in treatment?

Cedric Francois: And we do know that the referral processes and our DPC alongside of that is working.

Caroline Baumal: Okay. Great. Thank you so much.

Yeah, so we have a program, we've got actually a couple programs where we've got folks that are in these offices for Opthalmology and Optometry specifically for education and specifically. So uh patients cannot be identified and then referred to a treating Revenue specialist um and that has obviously um you know been running for quite some time now. But uh and we do see data in transition I will tell you 1 thing to keep in mind and as we move those patients over there are still a lot of patients inside these offices where the treaties injecting offices and run a specialist are um they could go on treatment because about 50% of the market system is offices already and then the market is very large as you know. So um there's opportunities on both sides. Yes. We can see that uh data. Um and we do know that the referral processes and our TPC alongside of that is working.

David Acheson: One moment for our next question. And that will come from the line of Derek Archilla with Wells Fargo. Your line is open.

Okay, great. Thank you so much.

1 moment for our next question.

David Acheson: Hi. This is Simone Roan for Derek. Congrats on the quarter. Just one question. Can you guys provide more color on the free drug trends, and how should we be thinking about the percent for the rest of the year? And is the 10 to 15 percent range still valid that you said last quarter? Thank you.

And that will come from the line of Derek archilla with Wells, Fargo. Your line is open

Hi. This is Simone on for Derek, congrats on the quarter. Um just 1 question. Can you guys provide more color on the free drug Trends? And how should we be thinking about the percent for the rest of the year and is the 10 to 15% range? Still valid that you said last quarter, thank you.

Cedric Francois: Yeah. So let me answer that on the free drug part of it. And like I mentioned a few minutes ago, we expect similar levels of drugs that's going to be used moving forward. We did have a $13 million headwind in the second quarter as a result of previous being used. But what I'm mostly encouraged by is that the demand at the physician and the patient level continues to grow. And that's why we see injection growth that we're seeing today.

yeah, so let me answer that uh, on the

Because being used um but what I'm mostly encouraged by is that the demand at the position and the patient level continues to grow and that's why we see injection growth that we're seeing today.

David Acheson: One moment for our next question. And that will come from the line of Judah Frommer with Morgan Stanley. Your line is open.

1 moment for our next question.

Srinath Raman: Hi. Thanks for taking the questions. First, just kind of on more of a high-level market penetration question. Do you see achieving kind of the market penetration in GA that you've discussed over time alone with SIPHOVRI and maybe additional patient and provider education, or do you think you might need a next-gen product like the 3007 combination to get there? And then secondarily, just just a housekeeping question on the SOBI loyalty. Can you walk us through how that's going to be recorded in the financials, whether it's going to run through the income statement or the balance sheet or both? Thank you.

And that will come from the line of Judah Frommer with Morgan Stanley. Your line is open.

Hi, thanks for taking the questions. Um, first just kind of on on more of a, a high level Market. Penetration question, do you see achieving kind of the market penetration in GA that you've discussed over time, along with cipo, and maybe additional patient and provider education? Or do you think you might need a next-gen product like the 3007 combination to get there and then secondarily just just the housekeeping question.

Tim Sullivan: Yeah. Thank you. Thank you so much for these questions. So first of all, as it relates to the penetration, I want to reiterate that we are now in a we have a stable business with SIPHOVRI with steady and gradual growth in front of us. And again, I think, you know, remarkable data over the course of a full four-year follow-up in these patients that allow us to really expand on what the efficacy profile means for this drug and what it means for patients, you know, to be on treatment. We do have, as you may know, a next-generation product in development. But this is a next-generation product that will actually combine SIPHOVRI with an easy-to-administer subcutaneous injection, which is an siRNA product.

On the SOI royalty. Can you walk us through how that's going to be recorded in the financials? Whether it's going to run through uh, the income statement or the balance sheet or both? Thank you.

Yeah, thank you. Thank you so much for these questions. So first of all,

Tim Sullivan: So what we're going to be testing in that clinical trial is whether we can give SIPHOVRI every three months and every two months, and whether the reduction of the lesion growth, which is, you know, 30 to 40 percent with SIPHOVRI, whether we can expand that and go hopefully well beyond 50 percent in terms of lesion size reduction. This would make it more convenient for patients, expand on the already impressive efficacy that SIPHOVRI has. And by the way, I want to point out here as well that in the four-year data set, we now have very clear indicators of the functional benefit that patients gain from treatment with SIPHOVRI. With this subcutaneous product, it's easy to administer, would be, you know, an auto-injector, and would make it every three months instead of every two months.

As it relates to the penetration. Um, I want to reiterate that we are now in a we have a stable business with Cy with steady and gradual growth in front of us. Uh, and again I think you know, remarkable data over the course of a full 4 years, follow-up, in these patients, that allow us to really, to expand on what the efficacy profile means for this drug and what it means for patients. Um, you know, to be on treatment. We do have as you may know in next Generation products in development, but this is a Next Generation product that will actually combine fory with an easy to administer subcutaneous injection, which is an essay product. So what we're going to be testing in that clinical trial is whether we can give safe probably every 3 months and every 2 months

Um, and whether the reduction of the lesion growth, which is, you know, 30 to 40%, uh, with that will be, whether we can expand that and go hopefully well Beyond 50% in terms of vision size reduction, uh, this would make it more convenient for patients expand on the already impressive efficacy. That's effectively has. And by the way, I want to point out here as well. That in the 4-year data set. We now have very clear indicators of the functional benefit that patients gain from female with that. For every, um, with this subcutaneous product, it's easy to administer would be, you know, an often injector and would make it every 3 months.

Tim Sullivan: Importantly, you know, I think we are the leaders in geographic atrophy, and targeting C3 is definitely very clear now the way to address the disease in the first place.

instead of every 2 months, uh, importantly, you know, I think we are the leaders in geography, and targeting C3, is definitely, uh, very clearly now,

Cedric Francois: Yeah, Judah, and I'll just jump in on your housekeeping question. So it's a very simple recognition. So the payment upfront will be recognized as revenue, and it'll show up on the balance sheet in cash.

The way to address the disease in the first place.

Srinath Raman: Great. Thank you.

Yeah, Judy and I'll just jump in on the on your your housekeeping question. So uh it's a very simple uh recognition. So the uh the payment upfront will be um recognized as revenue and it'll show up on the balance sheet in in cash.

David Acheson: One moment for our next question. And that will come from the line of Greg Harrison with Scotiabank. Your line is open.

Great. Thank you.

1 moment for our next question.

Joe: Hi, everyone. Thank you for taking our questions. This is Joe on for Greg. Just a quick one on C3G and ICM-PTM. How are you seeing the competitive landscape evolving there considering your competitors working on studies to kind of expand their patient population going forward? So kind of over the longer time horizon, how do you think that could play out within the value? Thank you.

And that will come from the line of Greg Harrison with Scotia Bank. Your line is open,

Tim Sullivan: Yeah. Thank you for that question. So first of all, again, I want to highlight that what we did in the Valiant study was to go very broad, right? We studied C3G and ICM-PTM. ICM-PTM is a separate trial for our competitor, which will take a while to read out. We also included the pediatric population. There is a separate trial for pediatrics by our competitor, which will take time to read out. And we studied pre and post-transplant as well. What is remarkable about Valiant is not just the fact that we had the trifecta of efficacy with kind of these profound beneficial effects that we saw across proteinuria, GFR, as well as the deposition of C3 in the kidney, but also how homogeneous that readout was across all populations. And that is why we got the label that we did.

Hi everyone. Thank you for taking our questions. This is Joe on for Greg. Just a quick one on C2G and I see MPGN. Um, how are you seeing the competitive landscape evolving? They're considering, you know, the competitors working on studies to kind of expand their patient population going forward. So, kind of over the longer time horizon, how do you think that could play out with me? Thank you.

Yeah, thank you for that question. So, first of all, again, I want to highlight that what we did in the Valiant study uh, was go very broad, right? We studied c3g and icmp PGN. Icmp gen is a separate trial for our competitor which will take a while to read out.

We also included the Pediatric population. There is a separate trial for Pediatrics by our competitor, which we will take time to read out. Uh, and we studied pre and post-transplant, uh, as well.

What?

Is remarkable about Valient is not just the fact that we had the trifecta of efficacy with kind of these profound benefits beneficially effects that we saw across.

Tim Sullivan: So I think, you know, moving forward, again, this is a product that can be life-changing for patients, and we look forward to providing it as soon as possible to as many patients as possible.

Joe: Great. Thank you.

David Acheson: One moment for our next question. And that will come from the line of Greg Suvanovic with Mizuho. Your line is open.

Srinath Raman: Great. Thanks so much for taking my question. I wanted to revisit a question that was asked earlier with respect to growth for the category. This is SIPHOVRI in GA. Relative to your comments about seeing a very stable business now where growth will be steady, and that's great to see, I'm wondering if you can again just revisit your thoughts around how your competitor is seeing or has projected that their product can potentially grow in the upper 20s on a quarterly basis. And if you have any insights as to whether that is a reflection of market growth and perhaps your view of low to mid-single-digit growth is perhaps conservative. Thanks.

Tim Sullivan: Yeah. Thank you so much. So again, I want to point out, first of all, our clear leadership in this category across every metric, right? Revenue, new patient share, overall market share, bios injections, preferred payer coverage, and then also the presence at academic conferences. We have these long-term data, and we have a very thorough understanding of the market dynamics. So you know we don't want to comment on what, of course, our competitor believes the market looks like. But I think the key thing here is that with the right data set in-house, which is a full four years of data in our hands consistently showing increasing benefits over time, the benefits of every other month dosing, where our competitor is still talking about the one-year data, which is many years old, I think we have a better grasp on what can happen within this space.

Great. Thanks so much for taking my question. I, I wanted to revisit, uh, a question that was asked earlier, um, with respect to, um, growth for the category, this is Sephora, uh, NGA, uh, relative to your comments, uh, about seeing a very stable business. Now where growth Will Be steady and that's great to see. Um, I'm wondering if you can again just, um, uh, revisit, um, your thoughts, around how your competitor is seeing, um, or has projected that, uh, their product can potentially grow in the upper 20s, on a quarterly basis. And, uh, if you have any, um, insights as to whether, um, that is a reflection of market growth, and perhaps your view of of low to mid single digit growth is perhaps, conservative. Thanks.

Yeah, thank you so much. So, again, I want to point out. First of all, our clear leadership in this category across every metric, right Revenue, new patients here, overall market, share files and injections preferred their coverage and then also The Presence at academic conferences. Uh, we have these long-term data and we have a very thorough understanding of the market dynamics.

So, you know, we don't want to comment on what's of course, our competitor. I believe the market looks like, but I think the key thing here is that with the right data set and apps which is a full 4 years of data, in our hands, consistently showing the increasing benefits over time, the benefits of every other month, toasting

We are a competitor is still talking about the 1 year data which is many years old. Um I think we uh we have the better grasp on um on what can happen within this space.

David Acheson: One moment for our next question. And that will come from the line of Lisa Walter with RBC. Your line is open.

1 moment for our next question.

David Acheson: Oh, great. Thanks so much for taking our questions. Maybe just one on Ampivelli. On the call on Tuesday, you know, you reiterated that Ampivelli has potential for blockbuster status. So I was just wondering, could you walk us through the path to get there? Does that also include further label expansion into other kidney indications or or even beyond that? Any color here would be helpful. Thanks so much.

And that will come from the line of Lisa Walter with RBC. Your line is open.

Oh great. Thanks so much for taking your questions. Uh maybe just 1 on and for Valley um on on the call on Tuesday, you know you reiterated that empty Valley has potential for Blockbuster status so I was just wondering, could you walk us through the path to get there? Uh, does that?

Tim Sullivan: Yeah. I think, look, I mean, we've shared with you the numbers on the demographics, right? So we estimate conservatively that there are 5,000 patients between C3G and ICM-PTM. That approximately half of these patients have ICM-PTM. That approximately 20% of these patients are transplanted. That probably about 15 to 20 percent of these patients fall in the pediatric category, which means that we would only be competing with the only other available products where we are differentiated, again, as we've outlined many times now, for 1,500 to maybe 2,000 out of those 5,000 patients. In terms of revenue, you know, every 1,000 patients could represent approximately half a billion dollars in revenue. So that is what this particular approval means for us in terms of potential revenue moving forward.

Also include further label expansion into other, kidney indications, or or, or even beyond that. Um, any color here would be helpful. Thanks so much.

Yeah, I think.

Look, I mean, we we shared with you, the numbers on the demographics, right? So we estimate conservatively that there are 5,000 patients between c3g and icmp GM.

Uh, that approximately half of these patients have icmp Jen that. Approximately 20% of these patients are transplanted.

That probably about 15 to 20% of these patients fall in the Pediatric category, which means that we would only be competing uh, with the only other available products where we are differentiated again. As we

Outline many times now.

For 1500 to maybe 2,000 out of those 5,000 patients.

Um, in terms of Revenue, uh, you know, every thousand patients could represent approximately half a billion dollars in Revenue so that is what

Tim Sullivan: The additional potential approvals, NSFGS and DGS, obviously, will take some time to run the clinical trials and to find out if the drug works and how well it works in these indications would then be in addition to what we can do there. And of course, in the background, there's always the P&H business, which continues as well.

This particular approval means for us, in terms of potential Revenue, moving forward, the additional potential approvals and ssgs and GS obviously will take some time to run the clinical trials and to find out uh, if the drug works and how well it works in these indications would then be in addition to what we can do there and, of course, in the background, there's always the pnh business which companies as well.

David Acheson: Thank you. I'm showing no further questions at this time. I would now like to turn the call back over to Mr. Cedric Francois for any closing remarks.

Tim Sullivan: Thank you so much. And thank you, everyone, for your thoughtful questions. This concludes the athlete's second quarter earnings call, second one of the week. And we hope you have a wonderful rest of the day. If you have questions, don't hesitate to reach out to our team, and we'd be happy to answer what we can. Thank you.

Thank you. I'm showing no further questions at this time. I would now like to turn the call back over to Mr. Cedric Francois, for any closing remarks

Thank you so much and thank you everyone for your thoughtful questions. This concludes the update's second quarter earnings call second 1 of the week and uh we hope you have a wonderful rest of the day if you have questions. Don't hesitate to reach out to our team and

We to answer what we can.

David Acheson: This concludes today's program. Thank you all for participating. You may now disconnect.

you all for participating, you may now disconnect