Q1 2025 Apellis Pharmaceuticals Inc Earnings Call
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Speaker Change: Hello everyone and welcome to their Q1 2025 Apellis Pharmaceuticals Inc. earnings conference call. Hello everyone and welcome to their Q1 2025 Apellis Pharmaceuticals Inc.
Speaker Change: At this time, all participants are in a listen only mode. After the presentation, there will be a question and answer session. To participate, you will need to press star 11 on your telephone. You will then hear a message advising your hand is raised. To participate, you will need to press star 11 on your telephone.
Speaker Change: To withdraw your question, simply press star 1-1 again. Please be advised that today's conference is being recorded. Now it's my pleasure to turn the call over to the vice president of communications, Tracy Venise. The floor is yours. The floor is yours.
Tracy Venise: Good morning, and thank you for joining us to discuss Apellis' first quarter 2025 financial results. With me on the call, our co-founder and chief executive officer, Dr. Cedric Francois, chief financial officer Tim Sullivan, executive vice president of Commercial David Acheson, and chief medical officer Dr. Caroline Baumal is on the line for Q&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. These statements are subject to certain risks and that are based on our current expectations and that are based on our current expectations and that are based on our current
Cedric Francois: An uncertainties, an actual result to be deferred materially. I encourage you to consult the risk factors discussed in our SEC filing for additional detail. Now, I'll turn the call over to Cedric. Thank you, Tracey. And thank you all for joining us this morning. As many of you know, Apellis is a commercial stage bag of pharmaceutical company with two approved C3 targeting therapies, Cyphery and Ambivali, and a growing pipeline of novel therapeutic compounds. Thank you for joining us this morning.
Cedric Francois: Our focus is on addressing diseases with significant unmet need through targeted inhibition of the complement system.
Cedric Francois: The first quarter of 2025 presented a combination of challenges and progress. [inaudible]
Despite growth and injection demands, [inaudible]
Cedric Francois: We faced a unique set of market dynamics that impacted sci-fowry revenue performance. Meanwhile, we advanced empathy closer to its second approval with the FDA granting priority review designation for C3G and ICMPGN and APDUFAD that is now less than three months away. Let's begin with sci-fowry. While first quarter sci-fowry injection demands grew 4% quarter over quarter, revenue came
Beelo Expectations. [inaudible]
Cedric Francois: We believe that this shortfall was primarily driven by two factors. [inaudible]
Cedric Francois: As mentioned already in our Q4 earnings call, there were funding shortages at third-party co-pay assistance programs.
Cedric Francois: There was also a larger than expected drawdown of total channel inventory during the first quarter, including in physician offices. [inaudible]
Cedric Francois: Demand David will share more details on these dynamics shortly.
Cedric Francois: Competitively, we continue to strengthen our market leadership within geographic atrophy.
Cedric Francois: Cypheri maintains more than 60% of the overall markets and new patients starts continue to grow, exceeding 50% during the first quarter and already reaching 55% by late April .
Cedric Francois: GA represents a significant unmet maze, and GA therapies are only in the early stages of adoption.
Cedric Francois: We expect continuous but modest market growth in the near term, and are confident that our efforts in the field will translate into meaningful growth for size-overy over time. [inaudible]
Cedric Francois: Shifting now to Empathy, where we are gearing up for a major launch of our second potential blockbuster opportunity.
Cedric Francois: We have made significant strides towards our goal of bringing empathy to more patients in the first quarter.
Cedric Francois: Supplemental NDA for C3G and ICMP was accepted by the FDA and granted priority review designation with APDUFA date of July 28. [inaudible]
Cedric Francois: The phase three valiant results demonstrated empathy's potential for disease modification across all patients subgroups, achieving the trifecta of glomerular disease endpoints.
First, an unprecedented 68% reduction in proteinuria.
Second, Stabilization of Kidney Function, as measured by EGFR. [inaudible]
And finally, substantial clearing of C3C staining.
Cedric Francois: We look forward to presenting the Valiant 52-week data at the European Renal Association Congress in early June.
Cedric Francois: U.S. approval and launch of Empaveli in C3G and ICMP Gen will represent Apellis's third new product launch in just four years.
Cedric Francois: We are carrying this momentum forward and looking to build on the success of MPAVETI in rare nephrology indications.
Cedric Francois: We remain on track to initiate pivotal studies in focal segmental glomerular sclerosis and delays craft function in the second half of this year.
Cedric Francois: I will now turn the call over to Tim to provide a review of the financials from the first quarter. Tim?
Thank you, Cedric.
Tim Sullivan: We are very encouraged by the growth and cyclore injection demand during the first quarter.
Tim Sullivan: Injections are the true measure of demand, and this performance gives us confidence that the market for cyphe ovary is growing. However, cyphe ovary net product revenue was 130 million for the first quarter, which was down due to two primary factors.
Tim Sullivan: First, there was a unique inventory dynamic impacting the first quarter, as you can see on slide six. [inaudible]
Tim Sullivan: During Q4, physician demand drove a larger than expected build of inventory in physician offices. [inaudible]
which led to a corresponding inventory increase at the distributor.
Tim Sullivan: We believe this increased physician demand was driven by stronger preference for psychoverry and regulatory concerns for the competitor product.
Tim Sullivan: Then, in Q1, we saw a drawdown of inventory at both the distributor and physician offices, and total channel inventory returned to more typical levels by the end of the quarter. The end of the quarter, the end of the quarter, the end of the quarter,
Tim Sullivan: Most of the quarter-over-quarter revenue decline was related to this Q1 channel inventory drawdown.
Tim Sullivan: The second impact to syphovery revenue was a funding shortage at third-party co-pay assistance organizations that resulted in increased physician and patient reliance on samples.
Tim Sullivan: As we discussed in our fourth quarter call, in connection with the funding shortage, non-revenue generating sample doses delivered from more than twice the average seen in previous quarters.
Tim Sullivan: We expect a similar amount of samples to be used going forward.
Tim Sullivan: We estimate that this shift to sample use impacted Q1 revenue by approximately $10 million. $10 million.
Tim Sullivan: To put it simply, adjusting Q4 and Q1 for this inventory dynamic, revenue would have been consistent quarter over quarter. [inaudible]
Tim Sullivan: Without the co-pay assistance funding shortage, we would have expected growth to have been more in line with injection growth.
Tim Sullivan: We spoken about demand, and now let's turn to price dynamics.
Tim Sullivan: We continue to diligently manage our ASP for average sales price, and expect the Cypheri Gross to net percentage to be in the low to mid 20s through 2025.
Turning now to operating expenses. [inaudible]
Tim Sullivan: We execute a significant cost savings in late 2023, and have since maintained that financial discipline into 2025, completing the necessary reduction in our EU commercial infrastructure, while also efficiently scaling for successful launch in C3G and ICMPGN. [inaudible]
Tim Sullivan: We continue to expect that our 2025 operating expenses will remain in line with our 2024 operating expenses. We continue to expect that our 2025 operating expenses will remain in line with our 2025 operating expenses.
Tim Sullivan: Also, we are closely monitoring the tariff situation and will take steps to mitigate any adverse impact it could have on our business.
Tim Sullivan: With 358 million in cash and cash equivalents at the end of the first quarter, we remain confident that our existing cash, combined with future product sales and ex-US royalties, will be sufficient to fund our business to profitability.
Tim Sullivan: I will now hand the call over to David for a commercial update. David? David?
David Acheson: Thank you, Tim, and good morning, everyone. In the first quarter, there were approximately 92,000 Cypherodosis delivered to position offices, including 82,000 commercial doses and 10,000 samples.
Speaker Change: As Tim and Cedric noted, there is a funding shortage at the co-pay assistant programs that has impacted demand for commercial doses, resulting in increased sample usage. Despite this headwind, we successfully drove growth in total injection demand in the first quarter.
Speaker Change: Syphoverd remained the clear market leader with overall market share exceeding 60% and share of new patient stars above 50%. Injection demand continued to grow with the share of new patient stars already reaching 55% by late April .
Speaker Change: The remains tremendous opportunity in the GA market. We've put several initiatives in place to continue to drive demand and new patient starts, including leveraging our DTC campaign where we have seen a meaningful increase in traffic to Cyphobary.com relative to the monthly average in 2024. We have seen a significant increase in traffic in Cyphobary. We have seen a significant increase in traffic in Cyphobary.
Speaker Change: Once patients reach our website, they can use our Find a Doctor tool to identify redness specialists that are experienced in treating GA.
Speaker Change: We are highlighting Syphover's unique 48-month Gail Extension study results that demonstrated Syphover's ability to preserve meaningfully more retinent tissue when physicians treat patients early and keep them on treatment over time.
Speaker Change: We've built a robots field team that is focused on growing the market through educating optometrist and ophthalmologist on the importance of treating GA and psychoveries differentiated product profile. Thank you very much.
Speaker Change: We also provide resources so that the GA patients can seek treatment with a retina specialist.
Speaker Change: To mitigate issues with the copay assistance programs, we are launching education programs on best practices for managing patient reimbursement. [inaudible]
Speaker Change: We're working to educate practices about patient-benefit designs, potential impacts to out-of-pocket expenses, and how our Appellis assists program can offer education to red in offices.
Speaker Change: Sypholre's Games in New Patient Sarts reflected its differentiated profile as resonating, driven by its robust efficacy, flexible dosing, and preferred position with many pairs. [inaudible]
Speaker Change: Turning now to the anticipated launch of Epivelli in C3G and ICMPGN. The commercial and medical teams are ramping up their efforts in anticipation of Epivelli's potential label expansion later this year. We are executing several pre-launch activities and working to drive disease state awareness.
Speaker Change: Our approach to maximizing the potential for amphibility in these diseases is three-pronged. First, highlight the urgency for a treatment that addresses underlying disease pathology.
Speaker Change: Second, Insurer Seamless Access to Treatment for Patients Upon Approval, and third, Establish Impavili as the Market Leader in C3G and ICMPGN.
Speaker Change: Our field teams are already in place in building relationships with key position accounts. We're working with payers to ensure coverage and access to empathy upon approval. We're also engaging with physicians and KOLs at medical conferences. [inaudible]
Speaker Change: The U.S. Commercial Opportunity is significant with an estimated 5,000, C3G, and ICMPGN patients. Given the strength of the valiant data, we believe Epivali will be used across all patient groups and disease severities.
Speaker Change: As many C3G and ICMPGN patients will progress to end-stage renal disease, physician feedback has been consistent that treatment choice will be primarily based on efficacy, not route of administration. .
Cedric Francois: As Cedric mentioned, full 52-week data from the Valiant Study will be presented at the ERA conference in June . We expect this to drive further excitement for
Cedric Francois: Switching now to P&H, net product revenue for Impaveli and the first quarter was 20 million. Compliant rates remain high at 97%, and the safety profile remains consistent with our previous updates. With that, I will now turn the call over to Cedric for closing remarks.
Cedric Francois: Thank you David. As we discussed, there is a lot to look forward to.
Cedric Francois: The remainder of 2025 will be a pivotal year for execution.
Speaker Change: I am confident in our team's ability to capitalize on the strong physician demand for cypherry, and I am excited about potential for empathy to transform the treatment in C3G and ICMPGN. We continue to make progress towards becoming a profitable, well-established biotechnology company with a promising pipeline and approved products across retinal nephrology and hematological diseases. Our objective is clear. Successfully execute our steps
Speaker Change: Strategy, drive revenue growth, maintain financial discipline, and most importantly, continue to deliver meaningful treatments to patients in need.
Speaker Change: Before I open it up for Q&A, I would like to take a moment to welcome the newest member to our board of directors, Craig Wheeler. I would like to welcome the newest member to our board of directors, Craig Wheeler.
Greg: Greg is the former CEO of Momenta, and founder and CEO of Headwaters Biotic Advisors.
Greg: He has more than 30 years of leadership experience across the bio-pharmaceutical industry and has successfully grown companies into strong commercial organizations with robust pipelines. His expertise will be a tremendous asset, and we are thrilled to have him join the board. [inaudible]
Speaker Change: With that, I'll turn the call over to the operator for Q&A.
Speaker Change: Thank you so much and as a reminder to ask a question, press star 11 on your telephone and wait for your name to be announced.
Speaker Change: To remove yourself, press star one one again. In as a courtesy to other analysts, we ask that you please keep your questions to one. Thank you. Please stand by for our first question. Thank you very much.
Speaker Change: Any concern the line of John Miller with Ever Quarer, please proceed.
John Miller: Hi guys, thanks so much for taking my question and congrats on all the progress.
John Miller: I would love to just be really, really clear about one few volume dynamics, I guess, in my question. Obviously, there's a couple of moving parts to this.
Speaker Change: According to the COPA Assistance Program, was a known headwind, we talked about last quarter, but it seems like maybe that's larger than it was expected. Do we know? No.
Speaker Change: When that's going to roll off or how all of these dynamics are going to change as we move forward to the rest of the year. Can you use a square of those circles on volume? A change is for you, the one cute for me. [inaudible]
Speaker Change: Thank you so much, John. Great to hear you. Well, I will hand it over to Tim for details.
But what I want to stress is that we've had...
Tim Sullivan: Quarter quarter growth in demands as measured by the number of injections that are given to patients with geographic atrophy, with Q1, as you correctly indicated, being the largest quarterly injection volume.
Tim Sullivan: Since the launch, that injection volume is a combination between commercial injections.
Tim Sullivan: and Sample Injections. So that is the true measure of demand, and as you correctly alluded to it as well. Of course, Samples are the ones that are mostly impacted by what is going on with the go-based systems funding situation.
Tim Sullivan: I'll hand it over to Tim to talk more about the embedding.
Thank you. Thank you. Thank you.
short
Tim Sullivan: So there were a lot of questions within that question. I'll try to touch on when I think was your main question there, which is...
So we had a Cedric set.
This 4% growth in injections, that injection growth constituted both. [inaudible]
Tim Sullivan: Commercial doses and sample doses, okay, those are sample injections and commercial injections, excuse me, so when you look at what we deliver, that's what's sent from, if it's commercial doses, that's what's sent from the distributor. . . .
to the physician. [inaudible]
Tim Sullivan: That's different from what the physician puts in the eyes, right? That's an injection. Let's make that distinction very clear. [inaudible]
Tim Sullivan: So we saw what we had was an inventory build at the end of Q4, both at the ECP level, so that's at the doctor's offices and their fridges, and at the specialty distributor. . .
Tim Sullivan: So what we saw in Q1 was a wind down of that inventory at the ECP level, right?
Tim Sullivan: which went to injections into the eye. We also saw an increase in the number of samples as a result of the switch that came from the underfunding of the co-pay assistance organizations.
Tim Sullivan: So that also impacted how much these doctors were ordering from the specialty distributors, so we had to draw down. That's where you see this reduction in files delivered, right? Thank you.
Tim Sullivan: That came from that lower demand for vial deliverance was because of the increase in inventory at the ECP level. They had to wind that down.
Tim Sullivan: So that's why you're seeing a difference between files delivered and the injection growth that we saw. I don't know if that clarifies your question or if there's some other piece to it but that's that's where the discrepancy lies. [inaudible]
Speaker Change: Sure, thank you. That makes sense. But how do we think about that going forward into the future with sampling volumes, presumably continuing to remain high?
Speaker Change: Yeah, so what we saw was we saw a drawdown in the total channel, they sent it up, they sent it up, impacting not only the increase in inventory at the ECP level but also at the distributor, now. . . .
Speaker Change: We don't know exactly where the world will end up from an inventory perspective, but what we can tell you is that inventory at the end of the first quarter looked a lot like inventory in prior quarters, excluding obviously the fourth quarter. [inaudible]
Speaker Change: So, going forward, the impact really, you know, from a demand perspective. Thank you.
Speaker Change: Really is there's this ongoing use of samples we expect that's roughly about the same as what we saw in the first quarter and that from a commercial perspective. Joseph,
We hope to be basically in a baseline right now.
Speaker Change: So you're not expecting this copay assistance underfunding issue to be resolved anytime soon.
Speaker Change: We're not expecting that to be resolved anytime soon, but I think when you get to this inventory impact and vials, those are the two concepts you were talking about, those should be on a more normal and steady state going forward. Thank you very much.
Speaker Change: You know, excluding obviously what's shifted to samples and overtime will be great and David can comment on the potential to switch those samples to commercial overtime.
Speaker Change: Hey, hey, Jonathan, David, thanks for the questions, and I appreciate the discussion this morning. You know, we are working diligently to understand, and we know, you know, where the samples are being used. [inaudible]
in place of commercial injections and...
One of the things that we have...
Speaker Change: Done as we've done a lot of work with the offices to make sure that we're educating the practices.
Speaker Change: Around the patient benefit designs, and we've actually got some new programs and...
Speaker Change: Other work is being put in place by the team's incentives offices. [inaudible]
Speaker Change: so that we can transition those patients that are on samples over to commercial paid-for doses that are being used. So the work's in progress, and over time, I think we'll see that shift. But right now, we do anticipate the samples to be about the same.
Thank you.
Okay, thank you so much.
Thank you.
Speaker Change: Our next question is from Tazeen Ahmad with a Bank of America Securities. Please proceed.
Tahseen Ahmad: Hi guys, good morning, thanks for taking my questions. I did want to ask about your calculation of new patient share. It does seem a little bit different than the calculation your competitor stated on their, I guess, first release a few weeks ago or a couple weeks ago. Can you tell us how you derive share with new patients? Thank you very much.
Tahseen Ahmad: And then, how are you thinking about the potential for providing sales guidance? Again, the competitive, competing product company.
Tahseen Ahmad: Has issued sales guidance, which seems to assume pretty steep uptake going forward. You're not responsible for their guide, but what would you need to feel comfortable with on your end to provide sales guidance for Siphovering? Thanks. Thank you very much.
Speaker Change: Thank you, Tasim. I will hand the first part of your questions over to David and then Tim will talk about guidance.
Thank you. Thank you.
Speaker Change: Acheson, thanks for the question this morning. So one of the things that we do is we purchase a site of care data set that covers about 50% of the market. That's very accurate. All right.
Speaker Change: And we feel our data sets are as accurate as you can give in space. We know our competitor talked about claims database type of data, which we know is not as accurate, only covers a small portion of the market. [inaudible]
Speaker Change: At a high level, what we're focused on is growing the site's ovary leadership position, which we're clear of doing, and you can see that it's in the new patient's starch growth. We'll see you guys.
Speaker Change: And we're trying to go to the market as quickly as we possibly can about that. So we've launched several narrative terms and this is a long term and this is just to manage to do that.
Tim Sullivan: Which we can certainly talk about. I'll hand it over to Tim on the guidance part. Sure, thanks, Tazeen. Thank you so much.
Tim Sullivan: From a sales guidance perspective, we've obviously had a couple of pretty big dynamics happen over the last two quarters. We have the CRL for the competitor. We also have this underfunding of the patient co-pay assistance organizations. Thank you very much.
Tim Sullivan: So I think we really need to enter more of a steady state before we think about guiding around Syphobri. Now, married with that, we also have a new launch in C3G and ICMPGN, which we're really excited about, but, you know, which comes with, you know. [inaudible]
Tim Sullivan: Well, you know, a little bit of how big is this, and we'll, we'll, when we feel comfortable guiding, we probably want to guide on, on, on, both products, so.
That's probably the best thing to be right now.
Joseph Stringer, just maybe one.
Speaker Change: Brief Dutch Test, which you mentioned as well. I mean, for us, what is most encouraging is how quarter after quarter, since the early fall, we keep gaining on that new patient share, right? So the relative evolution over time creates a very clear trend for us.
Speaker Change: So I didn't want to follow up on that, Cedric. I think the reason why people would like to see it provide sales guidance is because there's a question about how big it is.
Speaker Change: The number of patients is large in GA, but how much of it is actually addressable in this market? I think people are trying to figure that out. And, you know, one of the two companies has provided what their view of what they think they'll do this year is. [inaudible]
Speaker Change: But when do you think, you know, forget about C-3G, let's talk about psychover, which is a much more mature lunch. When do you think, I mean, is it possible at all this year that you would feel comfortable? [inaudible]
Speaker Change: So I don't think it's likely we'll provide guidance this year. We don't do interim guidance. We'll consider it probably towards the end of the year. It took next year, but we're not going into it. [inaudible]
Speaker Change: And I think that it just got to the broader point of adoption. Thank you very much.
Thank you.
Speaker Change: You know, we see, as you see, quarter of a quarter, that growth is there, it's steady.
Speaker Change: It's a new space, a new disease indication, a new therapeutic modality, these things take time to find a place of adoption, but as you correctly outline, only a very small portion of patients which you have a gutropy have been treated so far. And the shift that we see gradually...
Speaker Change: and the Community of Physicians is meaningful. Maybe Caroline is here with us, can maybe brief comment on this as well. Thank you, Cedric. Hi, Tazeen. I think that similar to the wet AMD market, which started in the...
Speaker Change: Both diseases in both eyes and there's a lot of overlap so I think the market will continue to grow and that's based on my experience as well. Thank you very much.
Thank you, one moment for our next question, please.
It comes from Anupam Rama with JPM, please go ahead. Thank you very much.
Speaker Change: Hey guys, thanks so much for taking the question. Can you help us understand a little bit the payer landscape, post the label update for Iservay? What are the strategies to get some formulary wins here on the payer side? Thanks so much.
Speaker Change: Thank you, Anupam, great hearing, you lamented over today's adventure. Thank you.
Speaker Change: Anupam, David, thank you for the question. So, we have been very open and very clear that we've had preferred positioning with syphoverry on a number of plans, in particular some of the large Medicare Advantage plans, and that continues to exist.
Speaker Change: We haven't seen significant changes with the label update that's happened with...
Speaker Change: with our competitor. And in particular, I think what really drives a big part of that is if we have efficacy data with every of the month, those who interrupt us. Thank you.
Speaker Change: It's a few of six doses a year, so a major differentiator for us with our data and with our label, but we continue to see preferred positioning and nothing has changed moving into this year. Thank you very much.
Thanks so much for taking a question. Thank you.
Thank you, one moment for next question, please.
Speaker Change: It comes from the line of Salveen Richter with Goldman Sachs, please proceed.
Speaker Change: Hi, this is Sharon Akron, Salveen. Thank you for taking our question.
Speaker Change: So, could you speak to, this is with regard to APL-3-007, where you're initiating a phase to study with Cypoverine too.
versus Saif-Ur-Ri alone.
Thank you. Thank you. Thank you.
Speaker Change: Thank you so much for that question. So I quickly repeat it because your line was a little bit muted. So the question was whether our 3007 program. Thank you very much.
Speaker Change: Where we combine a subcutaneous injection with an SIRNA product that brings the systemic C-3 levels down by approximately 90%.
Speaker Change: If we combine that with the intravenous injection for Cyphery, which we will we are currently doing as you know every two months. [inaudible]
Speaker Change: But we plan to also test within every three month injections or combination of intravisual administration with this new product continuously.
Speaker Change: And the question is, what is the magnitude of benefit that we can expect from that? So, this is a very exciting program for us. I think that this will be, we obviously believe that this will be the next big innovation in the space in Geographic atrophy. Thank you.
Speaker Change: We believe that the protection that Saifovri has on full receptor cells by the analysis that we have done on the full receptor cells specifically is...
Speaker Change: Pretty much as good as it can be, the protection on the layer below that which are the retinal pigmented epitelial cells.
Speaker Change: We have increasing effects over time, slowdowns of 30 to 40, even although we have 42%. There, we think we can further improve and have an impact beyond that 40%.
Speaker Change: thresholds that we're bumping into right now. So if we could get North of 50, that would be an important improvement. We are also going to use...
Speaker Change: These next clinical trials to apply everything that we learned in terms of how you can measure the functional impact on vision with these therapies and I'm able to assess that much better than we have been able to do in the past.
Thank you.
Thank you.
Thank you.
Speaker Change: Our next question comes from Steve Seedhouse, with Cantor. Please proceed.
Speaker Change: Good morning. Thanks so much. I wanted to ask specifically about...
Speaker Change: I appreciate the comments that you're not expecting a near-term resolution to the charity, the copay assistance situation, but the question is, are you in dialogue with other industry members? [inaudible]
Seeking a solution. It sounded like Regeneron was open to...
Speaker Change: Contributing again, either to good days or to a new entity, something similar. Dr. Joseph Stringer, Dr. Joseph Stringer, Joseph Stringer,
Speaker Change: But basically wanted others in the industry to pony up as well. So are you in dialogue with folks, Regeneron or others, and is Apellis willing to pay some pro-rated amount?
Speaker Change: Along with other industry members into good days are some similar charity to bring that back online. Thank you.
Speaker Change: Thank you so much as before that question. So the answer to that question is no. We respect the...
Speaker Change: The full independence of these co-funding or these co-based systems organizations. We do contribute to them, typically at the beginning of the year, but you know sometimes. Thank you.
Speaker Change: That can also happen throughout the year. But we give that as entirely dissociated.
Speaker Change: Constribution from what we do, obviously with Typhoon of the S-Conversal product.
Thank you.
One moment for our next question please.
Speaker Change: Come from the line of Colleen Kusy with Beard, please proceed.
Speaker Change: Hi, good morning. Thanks for taking our questions. We have a follow-up on that. What do you see as the risk of the third-party co-pay assistance program coming back at all? Do you think that definitely going to happen or is that a risk that part of the business might go way completely? [inaudible]
Thank you.
Thank you, Colleen. I will hand that over to David.
Speaker Change: Yeah, Colleen, look, thank you for the question, first of all. We are, we don't know, it's unpredictable, right? I don't know what will happen with the funding of the Foundation overall. We have taken the approach that we anticipate, and we're working under the assumption that it won't. [inaudible]
Speaker Change: And that's what we do anticipate our sampling and our injections to continue to grow, but the balance between samples and commercial doses that are out there will be balanced a little bit differently. So that's where we sit on our observations up. Thank you very much.
Thank you.
Understood, thank you.
Thank you.
Speaker Change: Our next question comes from the line of Phil Nadeau with Tiddy Cohen, please proceed.
Speaker Change: All right, this is Alex on for Phil. Thanks for taking my question. Could you comment maybe on the potential tariff exposure for site fovery and Bavilli, and to what extent is manufacturing located XUS? Also, where is the Palace of Key IP domiciled? Thank you. Thank you.
Tim Sullivan: Thanks, yeah, this is Tim. I'll take the question. I appreciate it. Unfortunately, there's not much we can say that any of the really three parts to your questions. So first, we're analyzing any potential exposure to tariffs. And obviously, um...
Tim Sullivan: Medication tactics under these multiple terror scenarios are being evaluated, and we'll provide updates when we can on that, but we really don't have much more information. We do talk about, and we have disclosed where our drug substance per scythe ovary is manufactured, which is...
Tim Sullivan: Ed Fockin, and that are not for drug intermediate, where that is produced, so those are Switzerland and Japan respectively. But we haven't disclosed who we work with on drug product. And nor have we disclosed where IP is domiciled. So I'm afraid there's not a lot to tell you in those answers. [inaudible]
Understood. Thank you.
Thank you.
Speaker Change: Our next question comes from Eliana Merle, with UBS. Please proceed.
Speaker Change: Hey guys, thanks for taking the question. I'm just looking at the revenues reported versus the amount of commercial vials that you shipped.
Speaker Change: It does look like the net price per vial has gone down a bit. Can you just help us understand the dynamics here and what you saw with net price in 1Q? Thank you.
Speaker Change: I know you commented you expect growth to not in the low to mid-20s. [inaudible]
Speaker Change: Over 2025, but can you just clarify how that could potentially vary quarter to quarter and what you saw specifically in one queue? And then I have a follow-up question after, thanks.
Thank you.
Speaker Change: It's going to be a lot of those. Okay, so first let me let me start out with the difference between revenue, recognizing and then files shipped or doses shipped as we disclose it. So the first thing is we recognize revenue. [inaudible]
Speaker Change: When a dose is shipped to the distributor, that's not what we're disclosing to you. [inaudible]
Speaker Change: In terms of a bioship or a bioship, that's from the distributor to the doctor. So those are disconnected and you can't back into the price and that price that way. [inaudible] or a bioship or a bioship or a bioship
Speaker Change: Okay, so that's the first thing. And we talked about some of the inventory dynamics that changed how those ordering patterns were happening for the physician from the distributor. Again, that's what we disclose, but that's not what the revenue recognition comes from. [inaudible]
So I hope that, you know.
Speaker Change: I hope that answers your question. But from a close to net perspective, we were on the low end of the 25% range this quarter. And you know, it does fluctuate. We obviously gave a guide, you know, through the end of the year, between, it would be between 20 and 25% or you know, low to mid 20s. [inaudible]
Speaker Change: Great. Thanks, that's helpful. And then just in terms of like the demand growth, can you just elaborate a little bit more on what you're seeing in two cues so far? So this 4% injection growth that you saw in one cue? I guess is this fair for us to assume going forward in terms of injection growth, and how you're thinking about that. Thanks.
Speaker Change: Thank you so much for that question, and it was sort of, again, without providing guidance, I think what is really important here, what you picked up on.
It's that this border will go for a quarter of an event.
Speaker Change: As measured by the number of injections that are given to the number of patients that are out there, continues to grow. And last quarter, consequently, was the largest quarterly injection volume that we saw.
Speaker Change: That is not something that we expect to change. We are very early in the launch still in many ways. Only a small percentage of patients have been treated.
Speaker Change: And as Caroline alluded to earlier, this is something where you speak with physicians that have properly adopted the products. You know, you both find the numbers ranging all the way from Apple Tree. [inaudible]
Speaker Change: between 30 and 50% of my patients with geographic accuracy. So, you know, we're only in the very beginning stages and I think as physicians become comfortable with understanding the mechanism. So, let's go to the next stage.
disease, the drug that will continue to grow.
Thank you. Thank you.
Speaker Change: One thing that we're doing is we're introducing tools to help physicians and patients realize...
Speaker Change: The benefits of our product and being able to pull these into practice, we've presented on a GA prediction tool. We're working across multiple imaging and AI studies to give the physicians the tools that they need for their patients. We're working across multiple imaging and AI studies to give the physicians the tools that they need for their patients.
Great, thanks.
Thank you.
Speaker Change: Our next question is from Annabel Samimy, Whit Stifold. Please proceed.
Hi everyone, thanks for taking my question. [inaudible]
Speaker Change: Just going back to the issue of the inventory, I realized that you get some build in the fourth quarter in the holidays, but you didn't know last quarter that it was an outside of the two to three week norm.
David Acheson: I'll start and then I'll give the hand it over to David.
Speaker Change: The latest conversations are.
David Acheson: With the physicians on this topic.
David Acheson: But in terms of in terms of what we saw in December right right. After the CRM, we saw a sharp increase in demand for central great. Okay.
David Acheson: In terms of.
David Acheson: So as this order to the physician's offices, but it also correlated to three very importantly important metrics. The first was an increase in sexual re total injections of December.
David Acheson: The second one was an increase in new patient share of injections and you've seen that continue obviously in the chart.
David Acheson: It's in the deck.
David Acheson: And then finally, we saw a sharp increase in switches for competitor products. So all of these things together.
David Acheson: Contributing to the increase in inventory that we saw.
David Acheson: Q1, we saw this draw down to more typical levels and that was probably impacted further by the underfunding of this co pay assistance organization dynamic that we talked about.
David Acheson: But theres no question that the.
David Acheson: Okay.
David Acheson: Carl for the competitor.
Speaker Change: As well as the more limited label that they achieved is really change that conversation so with that I'll turn it over to David to talk a little more about that conversation. So Tim mentioned that one of the dynamics that.
David Acheson: We benefited from that.
David Acheson: Opportunity to gross I felt it was the CRM and the label situations regulatory situation that a competitor was under it and obviously that drove some business for us and actually we've continued to benefit from that.
David Acheson: And the opposite is I can tell you there is definitely more of a comfort level that the product the product will be reimbursed.
Speaker Change: This is our differentiator Ryan this is with the physicians.
Speaker Change: With the Payors, we are the only product Thats got an every other month dosing opportunity with high efficacy and that that's a separate or both with physicians and patients as well as at the payer level. So even though there was a label change that opened up the 12 month restriction for our competitive product.
Speaker Change: Clearly have benefits that they do not have and thats where were growing the business today.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Our next question is from Byron I mean with Piper Sandler. Please proceed.
Speaker Change: Yes, hi, guys. Thanks for taking my questions.
Speaker Change: You mentioned that samples.
Speaker Change: Kris about 5005 <unk> quarter over quarter.
Speaker Change: I assume that increase was largely due to the foundation you. So can you maybe confirm that that increase quarter over quarter was due to <unk>.
Speaker Change: There wasn't a co pay assistance through the foundation.
Speaker Change: And I guess moving going forward should we expect that that your samples will continue to grow as yes.
Speaker Change: The new patient growth continues and you'll have more patients.
Speaker Change: Go on.
Speaker Change: The samples without having a co pay assistance.
Speaker Change: Thank you.
Speaker Change: Over to David to speak about the trends looking forward on what to expect and how we're working on that.
Speaker Change: I think it's important to remember that when a physician administered is central to the ambitions.
Speaker Change: They make significantly less revenue than it is.
Speaker Change: <unk> administer a commercial injection to a patient.
Speaker Change: And what that indicates to you and I think this is important is that.
Speaker Change: Physicians GERD CPE, both patients take care of us following up with treatment.
Speaker Change: We're about bringing new patients on that even if the patient is not able to pay that.
Speaker Change: The physicians are trying to find ways to still treat these patients.
Speaker Change: <unk> at this property affects us.
Speaker Change: Yes.
Speaker Change: Much as 20% of the patients population now the goal moving forward is how are they going to switch as much as possible from surplus to commercial and David.
David Acheson: That's great. Thank you Cedric and look I also look at samples is true demand right. So it could've been easy for physicians to not use a sample based on what San Francis talked about but what we're doing to mitigate the issues as a couple of things we are working specifically with the practices inside the reimbursement discussions.
David Acheson: We're also doing educational programs that have been updated for practice managers to talk to other practice managers about making sure that the benefit programs that will benefit design programs that these patients are on we can find ways to transition them from the samples to the commercial doses and that his efforts that are currently underway.
David Acheson: And have been since the middle of Q1.
David Acheson: Thank you.
David Acheson: Thank you.
Speaker Change: Our next question comes from the line of <unk> <unk> with Citigroup. Please proceed.
Speaker Change: Your line is open please check your mute button.
Speaker Change: Hello can you hear me we can hear you now please.
Speaker Change: Just curious about the copay situation what is your level of visibility on that resolving.
Speaker Change: And the funding gap going away.
Speaker Change: In the ophthalmology sector. Thank you.
Speaker Change: Thank you David Yes, it did.
Speaker Change: Here from you just like we talked about a few minutes ago, we arent real sure it's not predictable at all and what will happen with the funding issue that's out there with a co pay assistance program.
Speaker Change: What we are doing is assuming that it will not be resolved and that's how we're operating moving forward.
Speaker Change: And for US, it's about making sure we transition patients from the samples to a commercial.
Speaker Change: Dose as quickly as possible, where we can educate offices to do that based off of benefit design and the plans that these patients are on so those are the efforts currently underway.
Speaker Change: Okay and could you talk a little bit about your launch plans and <unk> an ICM PGN. What are you working on now to have a strong launch out of the gates and have a differentiated message versus.
Speaker Change: These oral competitor.
Speaker Change: Yes, great question. Thank you. So look a couple of things we are again, a situation now where we have all field teams and all of our teams are currently and actively in the.
Speaker Change: <unk> working to profile accounts and to also understand.
Speaker Change: The links between Kols and whether patients are located and we've got a very specific set of accounts that were spending time went down to profile to understand where to launch and how to launch quickly.
Speaker Change: The other thing that we're working through is making sure that everyone through our medical affairs team that would like to know and understand the data can do that our biggest differentiator is of course in this market is the fact that our efficacy is twice that of the competitive products.
Speaker Change: Also believe that efficacy Ms space is going to drive decision, making not the route of administration. So we're focused on that as well.
Speaker Change: At the end of the day the teams have been out there since April and we've got until late July alright, terrific and it's all about making sure that we're ready to go for launch as soon as we get a script.
Speaker Change: Okay. Thank you very much.
Speaker Change: Thanks.
Speaker Change: Your next question comes from the line of Douglas Tsao with H C. Wainwright. Please go ahead.
Douglas Tsao: Hi, good morning, and thanks for taking my questions I guess David.
Douglas Tsao: Just given your sort of comments that you've assumed the foundation will come back on line I guess I'm trying to sort of understand some of the steps that you can take in terms of benefit design because most of these patients have some coverage. It's just the out of pocket, but they are not able to address and so I'm not sure.
Douglas Tsao: It just might be helpful to sort of understand some of the steps that you might be able to take to mitigate that that impact in.
Speaker Change: Do you see yourself being more or less affected or.
Speaker Change: Then your competitor and does the fact that you have sort of every other month dosing potentially become even more of an advantage in this environment versus segments.
Speaker Change: Patient population. Thank you.
Speaker Change: Absolutely. Thank you for the question I think you answered part of the question and so part of it.
Speaker Change: The advantage that we have is that we do have every other month dosing than high efficacy with that.
Speaker Change: With that modality I think one of the things in those offices for patients that we've struggled to pay a co pay 12 times a year could do that.
Speaker Change: Lead times.
Speaker Change: Which is which is great what we're doing to mitigate this as a couple of things to go a little bit deeper we have a reimbursement team as you're aware of in the field date no benefit.
Speaker Change: Lance and designed by each one of these plans very very well.
Speaker Change: One of the things that we do know about the reimbursement through the foundation is that in many times patients are going on reimbursement through the foundation that didn't need to.
Speaker Change: And it was a situation where it was just a benefit design that was missed and we're making sure. We're educating offices. So they understand that down to the patient level. The other thing is as we use the pellets assist wishes hour.
Speaker Change: Our patient hotline and also works with our offices.
Speaker Change: Help identify when these patients to have a benefit that will run.
Speaker Change: Out of pocket Max is hit for a specific patient we can help identify that for a specific patient and then put the offices to get that patient for treatment. So there is a fairly detailed plan behind the scenes that goes down to the patient level to help the offices manage with that.
Speaker Change: Okay, Great that's very helpful.
Speaker Change: Thank you.
Speaker Change: For our next question.
Speaker Change: It comes from Lachlan Hanbury Brown with William Blair. Please go ahead.
Speaker Change: Hey, guys. Thanks for taking the question.
Speaker Change: I guess, you're competitive mentioned based on seeing some signs of market growth.
Speaker Change: That's something that you've been investing in.
Speaker Change: So I was wondering if you can comment on.
Speaker Change: Is there anything you've seen good suggests that those efforts to kind of grow the market increase.
Speaker Change: Your diagnosis and referrals.
Speaker Change: Starting to bear fruit.
David Acheson: Yes. Thank you for the question. This is David So we are both working very diligently and grow the market we have DTC plans in place.
David Acheson: As you know for us both on TV as well as digitally with Henry Winkler.
David Acheson: Also have multiple different programs are in place to help folks to identifying patients that have.
David Acheson: Both in the trading offices in the non trading offices. We also have a very robust team. That's built to focus on optometry and ophthalmology offices that are not injecting and their sole purpose is to educate on geographic atrophy identifying the patients to have geographic atrophy, and then having the opportunity for those patients to have information.
David Acheson: And some sort of referral into an office there is an objection office.
David Acheson: And that is ongoing and has been ongoing since the first part of the year. So that's what we're working to do to grow the market and our competitors doing a number of opportunities, but I can tell you is that.
David Acheson: The market has been relatively flat coming into Q1, but.
David Acheson: We've been able to grow.
David Acheson: <unk> new to brand starts.
David Acheson: Robustly.
David Acheson: Vince.
Speaker Change: Late last year, which gives us comfort that we're going to see a continued growth in our brand as well as in the market moving forward.
David Acheson: Okay. Thanks.
David Acheson: Thank you.
Speaker Change: Our next question is from Ryan Deschner with Raymond James. Please go ahead.
Ryan Deschner: Hi, there good morning.
Ryan Deschner: Or do you think it is that the impact of an inventory drawdown and copay finding shortages continue.
Ryan Deschner: Have a significant impact on <unk> net sales.
Ryan Deschner: Typo.
Ryan Deschner: Going forward in subsequent first quarters I have a follow.
Ryan Deschner: Thanks.
Ryan Deschner: Sure I'll take those questions. So.
Ryan Deschner: There are always little inventory fluctuations.
Ryan Deschner: We really can't control, but.
Ryan Deschner: But these two events the first one obviously the CRM and the.
Ryan Deschner: Accelerated build that we saw.
Ryan Deschner: The fourth quarter.
Ryan Deschner: Obviously thats a settled issue at this point.
Ryan Deschner: And then in terms of the <unk>.
Ryan Deschner: Okay assistance organizations being underfunded, we look at that sort of a onetime issue that has continued effect. So in that sense. There is no kind of event, that's going to change any inventory dynamic we would expect neither of these two things impact inventory specifically going forward.
Ryan Deschner: And then can you tell.
Speaker Change: Tell us about your latest thinking on the impact of a new DTC campaign on sales across 2025.
Speaker Change: Yes, so far it's been very positive and what we could see early because it started in January.
Speaker Change: Branded direct to consumer campaign, we could see a very high.
Speaker Change: Spike and the additional hit.
Speaker Change: Hits to our website, which is kind of an early indicator metric that we look at before we can get robust David switches or information on patients that actually good product.
Speaker Change: And as early as we are all of our metrics are up quite a bit we're actually 30% higher this year.
Speaker Change: Just alone in Q1 than we worked all year last year on average per quarter on the number of actually website visits as well as actions that people either physicians or patients take beyond that so it's been positive so far.
Speaker Change: Thank you very much.
Speaker Change: Thank you so much. Our next question is from Judah Frommer with Morgan Stanley. Please go ahead.
Judah Frommer: Hi, good morning, Thanks for taking the questions just a couple more on sampling dynamics were curious if you could help us with whether there is a.
Speaker Change: Sensibly competition within sampling.
Judah Frommer: Are you seeing the competitive provide more examples and is there I.
Speaker Change: Got it.
Speaker Change: Inclination to compete with their level of sampling and then separately is there anything you can share on sampling into newer practices that you're penetrating versus existing customers. Thanks.
Speaker Change: Yeah no problem. Thank you.
Speaker Change: So let me first comment on our sampling efforts. So our sampling efforts are therefore physicians to take advantage of their offices when they are patients who want to treat and obviously its the co pay situations gotten away from the foundation funding issue.
Speaker Change: They can certainly manage to do that with an opportunity to treat patients.
Speaker Change: That is readily available for all offices, we can see it across both new and former traders and we do continue to add new treaters as we progressed throughout the launch so.
Speaker Change: And samples are used in almost all offices across patients I'm not going to comment on what we see from a competitive landscape and we don't see that data specific to their sampling efforts.
Speaker Change: But for US, we know that something Thats, a good tool for us to use under our current circumstances.
Speaker Change: Thanks.
Speaker Change: Thank you one moment for our next question. Please.
Speaker Change: And he is from the line of Greg Harrison with Scotia Bank. Please go ahead.
Greg Harrison: Hey, good morning, and thanks for taking the question maybe one on <unk> what are you seeing that led to the.
Speaker Change: Revenue declined this quarter.
Any inventory issues here or or something else.
Speaker Change: Involving demand just trying to understand that dynamic and what we could expect going forward.
Speaker Change: Yes, Thank you and welcome to Dover's tip for.
Speaker Change: Additional details.
Speaker Change: We are actually very happy with the stable situation that will be sound and <unk>.
Speaker Change: As you know there was an oral competitors that came in.
Speaker Change: A little over a year ago.
Speaker Change: It would be very good for us I mean, we have a stable business <unk> edge.
Speaker Change: Where we've actually had several patients that went to the world product and then decided to come back to that kind of bearing witness to the remarkable efficacy and safety profile of Petro.
Speaker Change: <unk>.
Speaker Change: The new launch coming up in <unk> that of course will we believe certain buffer into our second blockbuster opportunity.
Speaker Change: Excited about what we're seeing there we estimate approximately 5000 patients just in the U S 8000 patients ex U S and I want to point out again because of the breadth of patients that we studied in <unk> being adolescence, and adults ctrip and <unk> pre transplant and post transplant.
Speaker Change: We may end up competing on explorer.
Speaker Change: Maybe 15 hundreds to thousands.
Speaker Change: Out of these 5000 patients with again.
Speaker Change: Very powerful and differentiated efficacy profile.
Speaker Change: <unk> so.
Speaker Change: Loans that were.
Speaker Change: Incredibly excited the best for all the right reasons and that is not just around the corner.
Speaker Change: Yeah sure so so.
Speaker Change: If you look at the decrease in revenue there was.
Speaker Change: Probably about a third of that would be inventory.
Speaker Change: And pricing dynamics in the other two thirds would really just be sort of a small decrease in demand over time.
Speaker Change: Versus last year.
Speaker Change: Towards that.
Speaker Change: A leveling off of that change.
Speaker Change: So we've seen that actually incredibly good compliance <unk> switches to a competitor product in the first quarter I know, David you want to talk a little bit about that I think cedric touched on but we've seen.
Speaker Change: We do see is we see patients will go to the world Dr. P product, but a number of times, we've seen them come back.
Speaker Change: As a result of efficacy.
Speaker Change: The safety profile that we've presented with disabilities.
Speaker Change: Okay.
Speaker Change: Great. That's helpful. Thanks, so much.
Speaker Change: Thank you so much. Our next question is from Derek <unk> with Wells Fargo. Please proceed.
Speaker Change: Hey, good morning. This is <unk> on for Derik. Thanks for taking our question a quick one from US can you share some updated thoughts on your cash runway given first quarter sales came in a bit lower than expected and just discuss the puts and pulls as you move towards profitability.
Speaker Change: Thank you very much so.
Speaker Change: We're not changing our guidance on cash runway and profitability as we stated before we continue to expect that our 2025 operating expenses remained in line and obviously the only impact we've seen.
Speaker Change: Here from a revenue perspective.
Speaker Change: Transit inventory dynamics and.
Speaker Change: You have a little bit of an impact related to the to the switching to samples but.
Speaker Change: As we look forward, we expect the <unk> the launch of <unk>, which is targeted for Q3.
Speaker Change: To meaningfully contribute to our top line.
Speaker Change: Turning to our guidance as discussed.
Speaker Change: Okay.
Speaker Change: Alright. Thanks.
Speaker Change: Thank you so much.
Speaker Change: Our next question is from the line of Greg <unk> with Mizuho Securities. Please proceed.
Speaker Change: Good morning. Thank you for taking my question I just wanted to return to.
Speaker Change: <unk> and the growth dynamics, there could you just.
Speaker Change: For paint.
Speaker Change: Picture of where we are today in terms of prescribing.
Speaker Change: <unk> and perhaps just a complement inhibitor class.
Speaker Change: Should we expect that the growth outlook is more of a slow and steady grind.
Speaker Change: Or do you think that there is still a possibility for some sort of inflection some meaningful inflection.
Speaker Change: As we think about the total commercial potential of not only say probably about the class overall.
Greg Harrison: So thanks for that question, Greg So I will.
Speaker Change: Okay.
Speaker Change: Steady growth that's again takes them to adopt this Kevin I had mentioned earlier.
Speaker Change: We have in addition to the work that David is doing that he spoke to in terms of.
Speaker Change: Bringing physicians.
Speaker Change: Along with the journey there are a couple of things that will believe further acceleration points. One notable one is.
Speaker Change: Tools that we are working on that.
Speaker Change: That are in development what is important there is that we believe that we have the tools available to allow a physician and the patient to see the drug worked for them both on protecting retinal tissue as well as the impact that it can have on physical function of the patient that is something that is very exciting.
Speaker Change: We will create further acceleration in this space that Caroline can maybe briefly expand on this because there is a precedent for this.
Caroline Baumal: Yes, Thank you Cedric.
Caroline Baumal: Cedric highlighted we have actually the largest dataset of an approved product for the longest time period with favorable dosing and.
Caroline Baumal: So much experience from the anti VEGF era.
Caroline Baumal: To pull out data driven tools for physicians.
Caroline Baumal: We're able to use that to really understand the disease.
Caroline Baumal: Access their patients. So I think that that is something that has been missing at GAA and go really at the forefront of.
Caroline Baumal: Being able to hold the meaningful two Wilson algorithms for physicians and for patients. So people can understand.
Caroline Baumal: Have data coming up.
Caroline Baumal: We will respond best to say celebrate what's the patient experience.
Caroline Baumal: Functional improvements for patients and all of that will increase the market.
Caroline Baumal: Patients.
Caroline Baumal: Thank you.
Caroline Baumal: Thank you so much.
Caroline Baumal: And our last question comes from Lisa Walter with RBC. Please go ahead.
Lisa Walter: Oh, great. Thank you so much for taking our question.
Lisa Walter: Just one on the broader kidney space.
Lisa Walter: We recently saw some data.
Lisa Walter: Data from Arrowhead with their <unk> RNA and their early results.
Lisa Walter: Look to on par with Whatsapp Halter has shown an IGN.
Lisa Walter: I'm just curious would you consider also exploring your DCF by RNA and other kidney indications.
Lisa Walter: Thank you so much this is so.
Lisa Walter: The best couple of quarters, we've spoken about this.
Lisa Walter: The efficacy that you showed at <unk>.
Lisa Walter: Absolutely remarkable as we call it the address sector right because you've heard them.
Lisa Walter: In our remarks earlier.
Lisa Walter: What is really exciting here is that.
Lisa Walter: We did a thorough analysis, we just perfect or near perfect. We believe engagement of C. Three indicate the we had the signs.
Lisa Walter: Third piece, which next indications that there could be we could be exploring.
Lisa Walter: Absolutely that thorough analysis, we just said with two phase III clinical trials, one in delayed graft function.
Lisa Walter: <unk> and focal segmental glomerular sclerosis, I again is not one of those indications because those are the two next ones, where we believe we can make a meaningful difference indicate.
Lisa Walter: Alright, Thank you and maybe just one last one on Hong playful Murray I can't help it.
Speaker Change: Im just wondering if you can give us any more color on the ex U S plans.
Speaker Change: For instance, how is the launch progressing in Australia and Hong Kong.
Speaker Change: Mercedes with regular later, then progressing in Canada, U K and Switzerland, I mean any color here would be helpful. Thank you so much.
Speaker Change: Thank you so much for those questions. So in Australia is a little bit early but.
Speaker Change: So this isn't there, but the rest of that community.
Speaker Change: Meaningful and it's palpable.
Speaker Change: As it relates to other regions around the world we continue to do the work.
Speaker Change: We believe that the data as it continues to grow remember we have to get extension study.
Speaker Change: It's a month data available to US now it is undeniable.
Speaker Change: The benefit is that said before we can provide to these patients and that is something that we know.
Speaker Change: We will continue to work on with Brexit that patients convinced the best access globally for this product.
Speaker Change: Thank you and this concludes our Q&A session for today I will turn it back to Sanjay Francois for closing remarks.
Speaker Change: Thank you so much and thank you again, everybody for joining us this morning.
Speaker Change: It's been a special quarter for us.
Speaker Change: Of course in spite of what we saw in terms of revenue based on the dynamics, we see that continued growth in a market that has just started to grow.
Speaker Change: If we can make a huge difference for patients with <unk>.
Speaker Change: Also maybe just three months away from the launch.
Speaker Change: Look forward to speaking about the other elements of the company with you today and then it has to come. Thank you so much.
Speaker Change: And thank you all for participating in today's conference you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.