Apellis Pharmaceuticals (NASDAQ:APLS), known by its ticker APLS, has announced its financial results for the second quarter of 2024, showcasing the success of its blockbuster drugs SYFOVRE and EMPAVELI. SYFOVRE, in particular, has achieved over $0.5 billion in sales since its launch, with a strong double-digit percentage growth each quarter, including $155 million in net product revenue in Q2 2024.
EMPAVELI also performed well, with $24.5 million in sales, despite expectations of flat sales in the near term due to increased competition. The company is optimistic about its future, with a focus on the European market, expansion into new indications, and a robust market share in the treatment of geographic atrophy (GA).
Key Takeaways
- SYFOVRE continues to experience substantial growth, with over $0.5 billion in sales and a double-digit percentage growth each quarter.
- EMPAVELI generated $24.5 million in sales in Q2 2024, with potential expansion into new indications.
- Apellis is advancing multiple earlier-stage programs in complement science and expects to become cash flow positive in the future.
- The company has secured broad coverage for SYFOVRE with two large national pharmacy benefit managers.
- Despite competition, Apellis maintains a strong market share, with SYFOVRE holding approximately 50% of new starts in the GA market.
Company Outlook
- Apellis is confident in maintaining market leadership and becoming cash flow positive.
- The European market represents a significant opportunity, with a final decision on SYFOVRE's approval expected in Q4 2024.
- The company did not provide revenue guidance for SYFOVRE but may reconsider for the next year.
Bearish Highlights
- Sales of EMPAVELI are expected to be flat for the next 6 to 12 months due to increased competition.
- Delays in the EU approval process for SYFOVRE have been noted, although the company remains positive.
Bullish Highlights
- Apellis has a clear line of sight to positive cash flow and is strengthening its balance sheet.
- SYFOVRE is expected to drive growth in new patient starts, especially with the direct-to-consumer campaign.
- The company's contracting strategies and drug safety profiles are expected to support its competitive position.
Misses
- No specific revenue guidance for SYFOVRE was provided for the remainder of the year.
- No significant purchasing patterns were identified for the third and fourth quarters.
Q&A Highlights
- Volumes for SYFOVRE were up in July, and growth is expected to continue.
- The company is focusing on differentiating VALIANT in the post-transplant setting through efficacy.
- Direct-to-consumer advertising efforts are transitioning to focus on the benefits of SYFOVRE.
- Despite competitive dynamics, Apellis is maintaining a 50% share of new starts in the GA market.
Apellis Pharmaceuticals is positioning itself for long-term success in the GA market through strategic commercial activities, including expanding the prescriber base and increasing patient awareness. The company's strong performance and strategic planning, coupled with its confidence in the value it provides to both patients and shareholders, suggest a positive outlook for its continued growth and market dominance.
InvestingPro Insights
Apellis Pharmaceuticals (APLS) has demonstrated promising growth with its blockbuster drugs, reflecting a strong market presence. In light of this, there are several InvestingPro Tips and real-time metrics that investors should consider:
InvestingPro Tips suggest that analysts are expecting sales growth in the current year for Apellis, which aligns with the company's optimistic outlook and successful sales figures reported for SYFOVRE and EMPAVELI. However, it's worth noting that analysts are not anticipating the company to be profitable this year, and earnings estimates have been revised downwards by three analysts for the upcoming period. There are 9 additional tips listed in InvestingPro that can provide further insights into Apellis's financial health and market position.
From the InvestingPro Data, we can see that Apellis has a market capitalization of $4.45 billion, which is significant and speaks to the company's size and potential influence in the pharmaceutical industry. The Price/Book ratio as of the last twelve months ending Q2 2024 stands at a high 16.84, indicating that the market values the company's assets quite optimistically. This is particularly relevant as Apellis's liquid assets exceed its short-term obligations, suggesting a solid financial footing for near-term operations. Moreover, the impressive revenue growth of 240.74% in the last twelve months ending Q2 2024 further underscores the company's robust sales performance, which is crucial for investors to consider when evaluating the company's future prospects.
These metrics and tips from InvestingPro provide a comprehensive view of Apellis's financial landscape, complementing the company's strategic commercial activities and market dominance aspirations. Investors can access further details and tips on InvestingPro's platform to make more informed decisions.
Full transcript - Apellis Pharma (APLS) Q2 2024:
Operator: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals Second Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised, today's call is being recorded. I would now like to hand the conference over to Meredith (NYSE:MDP) Kaya, Senior Vice President, Investor Relations and Strategic Finance. Please go ahead.
Meredith Kaya: Good morning, and thank you for joining us to discuss Apellis second quarter 2024 financial results. With me on the call are Co-Founder and Chief Executive Officer, Dr. Cedric Francois; Chief Operating Officer, Adam Townsend; Chief Medical Officer, Dr. Caroline Baumal; and Chief Financial Officer, Tim Sullivan. Before we begin, let me point out that we will be making 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.
Cedric Francois: Thank you, Meredith. And thank you all for joining us this morning. We are in a unique position today with one and the potential for two, blockbuster drugs in the market, SYFOVRE and EMPAVELI, both of which are making a meaningful difference for patients. Past six months have been a period of continued progress and execution by the Apellis team, but we recognize that there are questions around the competitive landscape for SYFOVRE. Given this, I wanted to share some of my thoughts. SYFOVRE is the market leader in a category with only two available drugs, 1.5 million highly motivated patients and a long runway for continued growth. That said, there has been a lot of focus on near-term dynamics. Our competitor has recently had tailwinds driven by factors such as its new J-Code. They had every incentive to drive demand in new patient starts as much as possible and yet we saw approximately half of new patients choose SYFOVRE. Following last month's successful ASRS meeting, we believe SYFOVRE clinical profile is being viewed favorably by physicians and will drive more growth in new patient starts over time. The SYFOVRE launch has been one of the best launches in recent history, generating over $0.5 billion in sales in its first six quarters and achieving double-digit percentage growth every single quarter. More than 330,000 SYFOVRE injections are estimated to have been administered to patients, and this strong growth is continuing into the second half of the year. The GA market is growing significantly and SYFOVRE has only scratched the surface of its long-term potential. Importantly, the recent ASRS meeting was a strategic turning point for us, where our focus and our discussions shifted to SYFOVRE strong and differentiated efficacy profile. We have multiple analyses supporting the efficacy of SYFOVRE, and retina doctors are enthusiastic about the totality of these data. The favorable benefit-risk profile of SYFOVRE is becoming clearer to physicians with some key takeaways. One, both monthly and every other month SYFOVRE treatment showed a better efficacy profile than the competitor among patients with non- SYFOVRE GA at both 12 months and 24 months, as detailed in the matching adjusted indirect comparison post-hoc analysis presented. Note that no head-to-head clinical trials have been performed. Two, SYFOVRE is clinically proven to offer flexible dosing from day one. Every other month, treatment with SYFOVRE provides an even safer and more cost-effective treatment, while maintaining its strong efficacy. And three, regarding safety, vasculitis is rare and appears to be a first injection phenomenon. The estimated rate has remained stable at one in 4,000 per first injection. During the podium presentation at ASRS, the rest committee confirms this estimated rate as agreed that it appears to be only on the first injection. After this meeting, we continue to believe that we are well-positioned to continue growth and further cement our market leadership in GA for many years to come. Our singular focus is to ensure that every GA patient who needs treatment has access to SYFOVRE. This is how we expect SYFOVRE to continue on its path of becoming a multibillion-dollar drug. As for the European GA opportunity, we are focused on the CHMP reexamination process and are encouraged by the progress we made throughout the initial review. This was not an unexpected outcome, given that the process was reset back to day 180 of the initial review, and therefore led by the original rapporteur. We were encouraged to learn that in this recent opinion, multiple CHMP members disagreed with the negative opinion. Additionally, the external advisory experts were aligned on Microperimetry as the best available functional measure of GA. We are humbled by the broad support shown by the European retina community, and while we remain conservative in our expectations for the reexamination, we believe we are well-positioned heading into the appeal. To new rapporteurs were recently designated, and we continue to expect the final decision to be issued in the Q4 of 2024. Moving to EMPAVELI, which continues to elevate the standard of care for patients with PNH. EMPAVELI generated $24.5 million in product sales in the Q2. We continue to believe that patients on EMPAVELI are experiencing substantial benefits as demonstrated by its 97% compliance rate. Importantly, we are exploring its potential to expand into new indications and become a best-in-class treatment option for additional high unmet need areas. The upcoming Phase 3 VALIANT top line readout in C3G and primary IC-MPGN is the next milestone in this process. And we expect to present these data later this month. If the data are positive, we plan to submit a supplemental NDA to the FDA for approval. Regarding the pipeline, we are advancing multiple earlier-stage development programs, leveraging our core expertise in complement science to fuel the next phase of value creation for Apellis. We look forward to sharing our progress at an upcoming Investor Day towards the end of this year. And finally, from a financial perspective, we are benefiting from the growing product revenue generated by SYFOVRE and EMPAVELI and have actively taken steps to strengthen our balance sheet. We now have a clear line of sight to positive cash flow, allowing us to invest in future growth without having to rely on the capital market. Before I turn it over to Adam to discuss our commercial activities, I will close by saying thank you to the patients and physicians who motivate us to develop and bring important treatments to market and to the Apellis team who have shown unbelievable commitment and perseverance in getting these important medicines to patients and to our shareholders, many of whom have stood with us through these dynamic periods and provided a wave range support to us over the years. With that, I will now turn it over to Adam.
Adam Townsend: Thanks Cedric, and good morning everyone. I will begin with SYFOVRE. With revenue of about $155 million. Sales growth remains strong at more than 12% quarter over quarter. In the second year of our products launch, quarterly growth rates at these levels are a strong indicator of longer-term demand. We delivered over 79,000 commercial doses and approximately 5,000 samples of SYFOVRE in the second quarter. Demand continued to accelerate with June being our highest demand month since launch through the second quarter. We are particularly pleased to see the continued progress across the many factors driving growth, including new patient demand and a broadening prescriber base. Cedric mentioned some of the competitive dynamics, which I know is on everyone's mind, so let's start there. Our competitor had recent tailwinds driven by factors such as obtaining its new J-Code, and so it is expected that they would see their proportion of new patient share accelerate. We also saw an acceleration when SYFOVRE J-Code went into effect last October. However, we do not believe this is indicative of longer-term market dynamics. We have taken the long view on contracting. As we believe this is a large and growing market, and believe that discounting too aggressively now is unsustainable and will lead to price degradation over time. We are also executing our strategic plan in the field to reinforce SYFOVRE benefit risk profile. SYFOVRE remains the number one chosen treatment for GA with approximately 75% of the treated market as defined by the total number of patients treated. We believe SYFOVRE’s position as the market leader will continue to be driven by its differentiated efficacy profile and flexible dosing. Importantly, we are also focused on maintaining market leadership whilst growing the overall GA category. We are still in the beginning stages. Our estimate based on claims data is that about 13% of GA patients who have been diagnosed and are managed by an eyecare professional are currently being treated. In addition, only a small portion of newly diagnosed and treated patients are referrals, meaning that most patients currently receiving treatment were already being seen by a retina specialist. This suggests that the majority of GA patients have not yet been diagnosed or referred to retina specialists, reinforcing that we have only scratched the surface of the large opportunity for SYFOVRE. As I mentioned on our last earnings call, we are now executing the next phase of our commercial and medical strategy. After the ASRS meeting in 2023, we developed a two-phase strategic plan with a two-year timeline. Phase 1 was focused on being transparent and educating the retina community about everything we were learning at the time around safety. This past quarter, we shifted to Phase 2 of the strategy, which is focused on strengthening our leadership in this growing market. More than 2,100 sites of care have ordered SYFOVRE. We are now on our front foot, expanding the number of new physicians using SYFOVRE, deepening our relationships with existing SYFOVRE users, establishing strong payer access and reimbursement and increasing awareness and education for patients. With physicians, we are communicating a clean and simple efficacy message, highlighting SYFOVRE increasing effects over time, which is critical given that GA is a chronic disease. We are also sharing the microperimetry data from the GALE extension study. The only data for an approved GA treatment that demonstrates a visual function benefit in a pre-specified endpoint. This allows for a productive benefit-risk discussion with the every-other-month dosing option having a dramatically positive impact for patients, doctors and payers. We had a successful ASRS meeting a few weeks ago, our first big retina meeting leading with these messages and look forward to the upcoming fall congresses. We are also continuing to broaden our reach to more retina specialists, as well as other referring eye care providers who see 10 of 1000 of GA patients. Reaching these physicians and educating them on the referral process are key to developing the GA market. With payers, we have secured unprecedented and broad coverage for patients choosing SYFOVRE. We are thrilled to share that two large national pharmacy benefit managers have recently made SYFOVRE the only preferred treatment on their commercial formularies. As the preferred product, this means that the new patients with commercial insurance will have full access to SYFOVRE as the first-line treatment and an exception process will have to be undertaken for non-preferred or disadvantaged products. While payers have several considerations in making such decisions, we believe these decisions were driven by SYFOVRE compelling value proposition, highlighting its robust efficacy with increasing effects over time and both monthly and more importantly, every other month dosing. These two PBM [ph] decisions are important milestones demonstrating payers' strong belief in SYFOVRE clinical and economic value proposition. As ensuring broad coverage and seamless reimbursement is critical for the retina specialists. And with patients, we've launched the first phase of our branded DTC campaign in the spring, which is focused on encouraging patients to talk to their physicians about GA treatment with SYFOVRE. We're excited to launch Phase 2 of our branded DTC campaign, extending our relationship with the beloved Henry Winkler in the fourth quarter. This is a very large market and we will be methodical in executing this next phase in order to set ourselves up for the long term. We will continue to execute flawlessly and be focused on getting more doctors, patients and payers to understand the efficacy and the benefits that the leading GA drug can deliver. Now, let me shift to EMPAVELI. In the second quarter, EMPAVELI generated approximately $24.5 million in U.S. net product sales. The positive trends across the key leading indicators for the PNH patient population continue into 2024. Specifically, compliance rates remain high at 97%, and we continue to have a very strong safety profile. As we previously said, with the availability of an oral treatment for PNH, we are facing a more competitive market and expect sales to be flat at least through the next 6 months to 12 months. We continue to have new patients starting in Ravelli treatment, but this has been offset by some patients switching to an oral. Finally, I will echo cedric's enthusiasm regarding the opportunity to potentially expand EMPAVELI into C3G and IC-MPGN. This market is approximately 3 times larger than the PNH market, and there are no available treatments. If EMPAVELI is approved in these indications, we are confident that we can leverage much of our existing infrastructure to rapidly reach nephrologists and deliver EMPAVELI to the thousands of patients suffering from these diseases. With that, I will now turn the call over to Caroline. Caroline?
Caroline Baumal: Thanks, Adam, and good morning, everyone. We are looking forward to sharing the VALIANT data later this month. I'll talk more about this opportunity in a minute. I will first talk about SYFOVRE as our team was recently at the ASRS meeting in Stockholm where we had a significant presence with five oral presentations, including a late breaking abstract on visual function from Gail. We are particularly excited by these visual function data as this was the first time a geographic atrophy treatment had demonstrated a visual function benefit on a pre-specified analysis. Results showed that with respect to the Microperimetry endpoint, patients treated with Pegcetacoplan monthly or every other month developed fewer new Scotomatous points over 36 months compared to patients from the sham crossover group. Scotomatous points measure the areas of the retina that have lost all light sensitivity and therefore are no longer functioning. These results add to the largest body of evidence for our geographic atrophy treatment and reinforce the unprecedented effects shown by SYFOVRE to both meaningfully slow geographic atrophy lesion growth and, by doing so, preserve visual function. ASRS is one of the most important retina meetings of the year, and we had the opportunity to engage with many members of the retina community. This was a highly successful meeting for SYFOVRE and we heard repeatedly from doctors about its differentiated benefits. We look forward to continuing to engage with this community at upcoming meetings and to share the ongoing progress of SYFOVRE in patients with geographic atrophy. Moving to EMPAVELI. Later this month, we expect to share top-line results from our Phase 3 VALIANT study of Pegcetacoplan in people living with C3G and IC-MPGN, two rare and debilitating kidney diseases caused by uncontrolled complement activation and breakdown of C3. Patients are usually diagnosed in adolescence and about 50% advanced end stage kidney failure in 5 years to 10 years. Treatment options are generally a kidney transplant or lifelong dialysis, neither of which are curative. In fact, nearly 90% of transplant patients experience disease recurrence, and about half of them end up losing their transplanted organ. The phase three VALIANT study enrolled 124 patients with either C3G or primary IC-MPGN. This is the largest single trial conducted in these populations and the only Phase 3 study to enroll a broad population inclusive of adolescent and adult patients with native and post-transplant forms of disease. The primary endpoint of the VALIANT trial is a Log-transformed ratio of Urine Protein to Creatinine Ratio or UPCR, a key marker of disease progression in all patients at week 26 compared to baseline. We view success in this trial as the achievement of a statistically significant response to the primary endpoint, as well as positive effects in some of the additional secondary endpoints. Physicians have shared that this would be clinically meaningful for these patients. If VALIANT is positive, we plan to submit the supplemental NDA to the FDA for approval. Following the completion of the VALIANT study, patients were given the option to enroll into the VALIANT long-term extension study. We were highly encouraged to see that a hundred percent of the patients who have already completed VALIANT have now enrolled into depth. Beyond the VALIANT study, we are continuing to advance our earlier stage pipeline, such as our C3 siRNA, that is currently in Phase 1 development and our beam collaboration. Like Cedric said, we are excited to share more details about our pipeline programs with you at an Investor Day later this year. I will now turn the call over to Tim for a review of the financials. Tim?
Tim Sullivan: Thank you, Caroline. I will now provide an overview of our financials and some comments on our debt refinancing with Sixth Street. Additional details are available in the press release that we issued earlier this morning. Total revenue for the second quarter 2024 was approximately $200 million, including $155 million SYFOVRE and $24.5 million in EMPAVELI US net product revenue. This compares with $95 million in total revenue in the second quarter of 2023. Turning to the rest of the P&L. For the second quarter, cost of sales was $23 million; R&D expenses were $78 million; SG&A expenses were $128 million; and we reported a net loss of $38 million. As I previously stated, we are realizing efficiencies this year related to our restructuring in 2023 and continue to expect our total operating expenses in 2024, inclusive of R&D and SG&A expenses to be less than our total expenses in 2023. This year, we've been focused on strengthening our balance sheet. These efforts ultimately resulted in a strategic non-dilutive refinancing collaboration with Sixth Street that we announced in May. The deal allowed us to prepay our SFJ debt at a significant discount and to free up substantial cash flow. A quick look at the terms revealed how favorable this deal was. First, this debt facility provides us with up to $475 million of which $375 million became available immediately upon closing. We can access the remaining $100 million at our option over time. Importantly, this deal was debt neutral to Apellis. We replaced $366 million in payments due to SFJ over the next few years with $375 million from Sixth Street. The principal repayment is pushed out to May, 2030 when SYFOVRE revenues are expected to be closer to peak. Our payments are interest only until then. This deal also substantially improves our liquidity and provides flexibility to access at least $200 million in incremental non-dilutive capital as we continue to invest in profitable growth. And it includes a record-low credit spread. The overall terms were some of the best in biotech seen in recent history. In aggregate, since the beginning of the year, we have unlocked over $475 million in non-dilutive capital, including $100 million from the capped call unwind announced in the first quarter. Plus, we have the flexibility to bring in $100 million within the accounts receivable line, which can be increased to $200 million upon the achievement of certain milestones and $100 million more from Sixth Street. So, a total of $775 million in non-dilutive financial flexibility. This combined with the $360 million in cash and cash equivalents that we have at the end of June 30, 2024 puts us in a strong financial position where we are on a path to becoming cashflow positive and no longer having to rely on the capital markets to fund the business. Importantly, our ability to begin generating cash is possible in both the EU and non-EU scenarios. While we believe the opportunity in Europe is significant, the ramp to peak sales is much longer. And so, the main source of profitability in the near term remains growth in the U.S. I will now hand the call back over to Cedric for closing remarks. Cedric?
Cedric Francois: Thanks, Tim. We've had a very strong first half of the year. With two successful commercial products, a pipeline of innovative programs and development, and a strong financial position to support the business, I'm more confident than ever in our ability to continue creating significant value for our patients and our shareholders. And we will now open the call for questions.
Operator: Thank you. [Operator Instructions]. Our first question is going to come from the line of John Miller with Evercore. Your line is open, please go ahead.
Jonathan Miller: Yes, hi guys. Thanks so much for taking the questions. I would love to start with -- I'll start with this. Do you expect the share of new starts, currently around that 50% mark to grow again post a successful ASRS? And then I guess the corollary to that is, your guidance to cashflow positivity, you just mentioned doesn't assume anything more than U.S., GA launches, but does it assume more than the existing share of new starts in the U.S.?
Cedric Francois: Thank you so much, John. Great to hear you. So, that is of course the most important question, right? I mean, is the new starts in the second quarter as we have discussed, there were tailwinds for [indiscernible], but as we now move forward, what really stands out and what is very encouraging to see is a very large market and the fact that SYFOVRE is leading on efficacy, flexible dosing and economic value. So, as we move forward now, we plan to recapture the lead on those first injections and take advantage of this very large market with an important unmet need. Adam, do you want to add something?
Adam Townsend: Yes, thanks, Cedric. Hi, John. So, yes, we're in Phase 2 and we're already encouraged by the growth and the demand we're seeing into July. We're on the front foot. We're talking about efficacy. We're talking about every other month dosing. These are huge differentiating factors, spike drop. We can see the future and we can see that we will continue to be the number one GA drug in this market. Tim, do you have any suggestions?
Tim Sullivan: Yes. So, in terms of cash flow, our revenue was $199.7 and our cash OpEx if you take out stock-based comp and depreciation is just under that. So that was $199 a little bit less than that. So really on a total OpEx basis, on a cash basis, we are net neutral. So, the differences right now are working capital and of course interest expense. So, it really doesn't take much in terms of growth for us to become cash flow positive. We're not guiding to when that will happen. But given the size of the market and the growth in this market, I don't think that's something we're worried about.
Jonathan Miller: Great. Makes sense. And I guess my follow-up would be, your language on EU approval seems more positive now than it has in the past. You mentioned that you're well positioned heading into this appeal, and I think that's a little bit more positive than the previous messaging we've heard where we're all assumption all of our assumption was that this was not the base case. But how do you feel now versus how you felt the last time you had into an appeal? Do you really feel like the likelihood of an approval without further trials or without further resubmission is much higher now?
Cedric Francois: Thank you, John. So, the expectation should remain the same. What is of course, the one nice takeaway from the fact that the procedure was reset was the ability for us to introduce new data and that includes pre-specified endpoints of function, which is of course, something really important and encouraging and really speaks to the appeal of this drug to patients. So again, in terms of expectations, that has not changed. The process has gone according to plan. We've been disciplined. We look forward to the 4th quarters to share what the results are.
Operator: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Anupam Rama with J.P.M. Your line is open. Please go ahead.
Anupam Rama: Hey, guys. Thanks so much for taking the question. You guys noted that for SYFOVRE, June was your best month since launch. Maybe you could give us a little more color on what you were seeing on a month-by-month basis in the quarter. Was the AZERBA sort of J-Code impact more like first half of the quarter dynamic and then you saw reacceleration of SYFOVRE regrowth? Or how do we think about like what the dynamics were within the quarter? Thanks so much.
Cedric Francois: Thank you so much, Anupam. I will hand it over to Adam, but I think again what stands out here and what we're super excited about is how large this market is, the fact that it's growing, the fact that AZERBA does well in a duopoly that, we'll be here for a long time and us having a drug that is meaningfully differentiated on efficacy and dosing flexibility that is really what we are focused on. But Adam, you may want to add something. Yes.
Adam Townsend: Hey, Anupam. So yes, June was the highest month of the quarter and also the highest month launch today. Across multiple metrics, we saw that Q2 was a very successful quarter for us across the multiple months, right. we continue to grow accounts now can 2,0105, we saw double-digit growth for the quarter. We saw double digit growth for the quarter. We're fully into Phase 2 of our plan. And I think some of the initial steps of that happening in June is what we can witness there. Right? Talking about efficacy, talking about flexible dose and I think that's what we are really pushing hard as we now move to the next quarter.
Anupam Rama: Thanks so, much for taking my question.
Operator: [Operator Instructions]. And our next question comes from the line of Salveen Richter with Goldman Sachs (NYSE:GS). Your line is open. Please go ahead.
Unidentified Analyst: This is [indiscernible] for Salveen. Thank you so much for taking our question. So, on the competitive dynamics, what are the factors which are driving the competitive and physician dynamics in the GA market following the permanent J-Code for is? And could you speak to the market share that you're seeing at this point and how you expect that to evolve over the near term?
Cedric Francois: So, we are the market leader. We plan on continuing to be the market leader and that confidence is based on stability around the safety, which was really important and where SRS was a real turning point for us. -- those that were there, it was a quiet meeting on that front and the discussion very much shifted towards the efficacy profile. And there the majority of doctors clearly see the differentiation of SYFOVRE versus the competition. So, as we now move forward, the focal point will more and more become efficacy, the differentiation, the long-term data, the mass amount of data that we have with SYFOVRE, and then the real and important benefit of every other month dosing. So, the convenience that that offers to patients. Also, the fact that health the number of intravitreal injections is twice as safe as monthly injections. All of these things are going to come more into focus. I know Adam, if you want to add something?
Adam Townsend: Sure. So obviously, if you go back to our J-Code, we also noticed tailwinds when we had our J-Code, it unlocked certain new accounts. So, the competitor had some tailwinds. And even with those tailwinds we maintained approximately 50% of new starts and market leadership, 75% of the total market. That is down at Cedric said to a real successful execution of Phase 2 of our strategic plan, plus some positive comments moving forward from ASRS. Now, you also asked about market share. So, we track market share based on vials going into physicians and then being injected into patients. And so, we think that's the most robust way of measuring market share. And we had a 75% market share. Now, as this market grows, we will continue to push incredibly hard on our efficacy message, our dosing convenience, and the economic value. And we think that that will maintain our leadership moving forward.
Operator: And our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is open. Please go ahead.
Yigal Nochomovitz: Thank you, very much for taking my question. Shifting over to C3G and IC-MPGN -- I just wanted to get your thoughts on how you expect the position type for the Copeland in this market, assuming VALIANT is positive? And what do you think you need to show on proteinuria as well as some of the other secondary endpoints that Caroline mentioned to be competitive with the emerging oral options?
Cedric Francois: Sorry, Yigal, we had a hard time hearing it here. Tim, who has hearing translate for me. So, look, we are very excited about the opportunity in C3G and IC-MPGN. This is something that has been a little bit below the radar screen of most, but a really large and important opportunity for us. We have seen the results from the NOBLE study, where we have the histopath data, which is really best in class, ever seen within this disease. We also have already, while this drug is not on the market, yet seen the excitement around science for this drug. And we have seen in the NOBLE study, approximately 50% reductions in the protein area. So that is, of course, the goal for us is to meet statistical significance on the primary endpoint, and then to really pay attention to the transplanted population. So, I hope that answers your question.
Yigal Nochomovitz: No. That's helpful. And then, just another question. From people's design and VALIANT, we are combining C3G and IC-MPGN into one study. Obviously, the competitor is doing separate studies for both indications. Do you see that as being a significant difference in terms of how physicians will interpret and implement the data when both those are approved?
Cedric Francois: Yes, that will depend on the data, right? So, I think you bring up a very important point, which is that the way in which the study reads out should be viewed in the context of, of course, what we have seen with abate. We decided to include in one study both C3G and IC-MPGN, with the hope that the data would be good enough for both to find their way into our label. So, we're going to see if that's the case or not. And we're going to see how the data stacks up against what has already been disclosed by Novartis (SIX:NOVN) in the past months.
Yigal Nochomovitz: Great. Thank you.
Cedric Francois: Thank you.
Operator: Thank you. In one moment as we move on to our next question. And our next question is going to come from the line of Steven Seedhouse with Raymond James. Your line is open. Please go ahead.
Steven Seedhouse: Thank you. Good morning. Thanks for the update. First question, I just -- regarding a new line item on the balance sheet for long-term inventory, a $23 million entry. Has there been any change to the expected sales trajectory in the next 12 months versus prior? Are you anticipating that entry will be gone in subsequent quarters or is it going to grow? And then also what is the shelf life of the raw materials, I guess, that comprise that entry?
Cedric Francois: Yes, thanks, Steve. So that entry was put in place because we have to do our ordering for our inventory long and advanced. And we had planned for the potential success of ALS. There's also a couple of other factors, which include the delay in the EU for SYFOVRE and also our expected ordering from [indiscernible]. So, we had to plan for all that well in advance. And so much of that, in fact, most of it has to do with inventory. So, we don't know exactly how long that line item will last there, but most of that inventory has a shelf life of three years or more. So, we just put that in place because of the dynamics we talked about, but it's primarily in the value.
Steven Seedhouse: Okay. Good to know. And then just on the dynamic of patients, maybe switching between Izervay and SYFOVRE, do you have good visibility into both directions of switching there? And has it been -- if so, has it been sort of a net positive, net negative, or net neutral in terms of unique patients on either drug? Thanks.
Adam Townsend: Hi, Steve, it's Adam. So yes, we have some visibility to that now. Obviously, with all analysis that we can do. It's only a subset of the total market. So obviously, last year, we did see some switching from SYFOVRE to Izervay. We saw 1 or 2 accounts switch the majority of the patients. And what we have seen moving forward is we've actually seen some switching from Izervay come back to SYFOVRE. And our assumption there is that's based on the efficacy and the flexible dosing of this drug. Switching tends to be a very small piece of the market, and it goes both ways based on our data set. As we look forward into Q3 and beyond, right, we're really, really encouraged by all of the metrics we're seeing about strong demand across multiple metrics. That includes switching as a piece of it, a small piece of it. That includes new starts and our plan to execute everything to push new starts. It includes more physicians writing SYFOVRE for the first time and increasing the number of accounts that are using SYFOVRE. We're really, really positive on what we're seeing so far, and we think a lot of that's down to the strong efficacy, the leading efficacy, flexible dose and economic value. Hopefully, I see if that answers your question.
Operator: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Colleen Kusy with Baird. Your line is open. Please go ahead.
Colleen Kusy: Great. Thanks. Good morning and thanks for taking our questions. Can you provide any thoughts on when you might provide revenue guidance for SYFOVRE?
Cedric Francois: Sure. Thank you. So obviously, we're not providing it for the remainder of this year and it's something we'll reconsider for next year, but we're not guiding on the guide yet.
Colleen Kusy: Thank you. And then for the EU review, I think you said the repertoires have been selected. Can you provide any commentary on the background of the new repertoires and if either of them were a dissenting vote from the most recent review?
Cedric Francois: Thank you so much, Colleen. So, we don't provide details on that. As mentioned, we consider the ARPSO success to have remained stable, the process to have gone very much in line with what we had expected. And hopefully, in the Q4, we'll be able to come back with positive news.
Operator: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Phil Nadeau with TD (TSX:TD) Cowen. Your line is open. Please go ahead.
Phil Nadeau: Good morning. Thanks for taking our questions. On the competitive environment, first, [Technical Difficulty] and then second, the dynamics of competition, what do you think the position in center level overall? Are students becoming Izervay versus a focused position using both and setting centers one versus the other or are they using both? [Technical Difficulty]
Cedric Francois: Hey, Phil, I don't know if it's Arlen or yours, but we have a very hard time hearing your question.
Phil Nadeau: Sorry, Yes. So first on discounting, what are you seeing in the marketplace on discounting and what is the pelos Ozone strategy on discounting? And then 2nd on competition, can you talk about on the patient sorry, on the physician center level, are centers choosing one or the other or are they going patient by patient using either way versus --? Thanks.
Cedric Francois: Thank you so much. Adam, do you want to take that?
Adam Townsend: Yes. Hey, Phil. Thanks for repeating the question. Contracting's obviously a standard process in this market and we are taking a really strategic and thoughtful view on how we contract in this market? This is a large and growing market and we've only just scratched the surface of moving patients into the market. So, if you look forward to how big this market could possibly be, we want to maintain as much value as is possible. So, we've been incredibly thoughtful on contracting. Then to your second part of your question so at an account level, we have seen that there are many SYFOVRE advocates and fans and these physicians are choosing SYFOVRE for its leading efficacy, flexible dosing. It is now well documented safety profile and the robust real-world evidence and that comes consistently when we interact with physicians at conferences and various other interactions too. Now, no surprise, there are always some competitor physicians also, who tend to be choosing the competitor for its safety profile. One thing we have noticed, and I don’t know if Caroline wants to comment afterwards is, a lot of physicians will have a discussion about SYFOVRE, for example, with their patient and explain the efficacy profile and the flexible medicine. And some physicians will have the same conversation on eyes. So, the patient voice is also important in this discussion, and we truly believe that efficacy will drive patients to want to choose SYFOVRE. Caroline, anything you want to add?
Caroline Baumal: I think when it comes to physician [indiscernible], just had an ad board yesterday and speaking with my colleagues at ASRS, they're very driven to have less than monthly dosing, which is consistent with the high efficacy. And they're really also driven by our data that goes into the third year of use that patients have completed the Gale study. Some patients with over five years of continuous use of SYFOVRE. So, to them, the most important thing is to give the maximum efficacy with the least burden for patients.
Operator: Our next question comes from the line of Akash Tiwari with Jefferies. Your line is open. Please go ahead.
Ivy Wang: This is Ivy on for Akash. Thanks so much for taking our question. So, you've alluded to a safety update second half of this year. Just wanted to get a sense of what that could entail? Also, given Ivey has half the amount of PEG in a shorter half-life compared to SYFOVRE, are you working with ASRS other doctors to run studies looking at dose titration or spaced out dosing regimens, foresight, SYFOVRE? And when can we get an update on that?
Cedric Francois: So, first of all, the safety is now very clear and well established. And what was really important for us was that SRS -- the SRS REST committee agreed with aped on the rarity of these events, one in 4,000 on the first injection, and the fact that this is primarily a first injection phenomenon. So those are important facts and of course then you place it in the broader context of the safety where SYFOVRE stacks up very well against Izervay specifically, also because of that every other month of dosing that is available. So, based on an enormous denominator of 330,000 injections, we know very well what the safety profile is. I don't think there's going to be much more discussion around that. What we will talk a lot about now is what the efficacy really looks like. And I think that is where the discussion is going to go. What was really gratifying to see coming out of ASRS is that everything is becoming more quiet and more reasoned within this field. So only 13% of patients with GA right now have been treated. These patients are desperate for treatment. They are going blind. Understanding the safety profile and the efficacy that they get in return is really important and is going to drive the growth of this market for many years to come. So that is something that really stood out. In terms of mitigations, for something as rare as this event, it is a question, what can you do? What should you do? It's of course, when it happened, it's not good, but, intravitreal injections carry a risk. Every time you do an intravitreal injection, there's a chance of one in 3,000 to 5,000 of getting infection and of endophthalmitis as well. That is normal with any type of drug. So, this is really something that we're looking forward to. I don't know if Caroline wants to add something.
Caroline Baumal: I think the retina community has really appreciated our transparency with this and our partnership. I mean, we are driven by science and we're driven by the best for patient care. And that is the continual feedback. And I will tell you that the community would have no problem giving different sort of feedback if that was indicated. So, they're really pleased with this and they're really excited to continue to work with us and develop more data for our patients to give them the best care.
Cedric Francois: Yes, and we're really feeling that momentum this quarter. I mean, it's really, I think SRS was a real training.
Ivy Wang: Great. Thank you so much.
Operator: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Eliana Merle with UBS. Your line is open, please go ahead.
Eliana Merle: Hi guys, thanks for taking my question. Just a quick one on SYFOVRE and then a question on VALIANT. Sorry if I missed this before, but can you confirm if volumes were up in July versus June for SYFOVRE? And then for VALIANT, just how are you thinking about what's clinically meaningful in the pre-versus post-transplant setting? And then any difference in efficacy expected between these two settings and just commercially how you're thinking about the relative size of the population opportunity for pegcetacoplan in the pre versus post-transplant patients? Thanks.
Cedric Francois: Thank you so much. Adam, do you want to take this first?
Adam Townsend: Sure. Yes, so we're really thrilled with the strong growth because it's continuing into July and we expect it to continue for the rest of the quarter and onwards. We're seeing it across multiple metrics and I think it's down a lot to flawless execution of Phase 2 of our plan. We are now on the front foot and we're pushing hard. So, we're thrilled with what we're seeing into July. We expect that to continue. We're going to work hard to make sure. And then as it relates to VALIANT, so pre versus post-transplant. So, as you may recall, Eli, for us, the post-transplant segment is a very intriguing one because it's easy to take biopsies and to track on histopathology what your drug does in that population. It is also a population that was kind of deprioritized by our competitors and it's one that we happily embrace because what is best for a transplanted kidney is best for kidneys with this disease, period. So, this is really something that has many advantages for us to focus on. But on the other hand, should our data be really good in VALIANT, there is a real opportunity to differentiate from [indiscernible] and to know in a disease as serious as C3G or IC-MPGN, efficacy is what will really, really matter. More than convenient straight, whether you take a pill or subcutaneous. If you have a real differentiation on efficacy, that is what we'll stand out. I also want to point out, of course, we've always talked about the remarkable safety profile that we've seen in PNH and the other indications where SYFOVRE has been used and is on the market, combined with this extraordinary compliance rate of 97%. SYFOVRE, which has the same active ingredient as SYFOVRE is an amazing drug and hopefully in Valeant, we will see a new indication emerge for that drug.
Operator: Thank you. And one moment as we move on to our next question. And our next question comes from the line of Annabel Samimy with Stifel. Your line is open. Please go ahead.
Annabel Samimy: Hi, all. Thanks for taking my call. So, I guess in our channel checks, we're happy to find that consensus among these physicians we spoke to is generally in line with your comments that physicians give SYFOVRE that edge on efficacy. I guess my question is, how are they responding to the micropurgatory data? Because it's not something that they typically do in their offices. So how can they use that with their patients practically so they can show patients benefit over time and keep them motivated? And I ask that, I guess for retention beyond that, say, 18 months to 2-year timeframe where patients may start dropping off? Do they have the tools right now? And are they starting to adopt some of these tools so they can demonstrate to their patients that this is working? Thanks.
Cedric Francois: Thank you, Annabel. Adam is going to first answer the first question.
Adam Townsend: Yes. Thanks Annabel. So, I appreciate your comments on efficacy. We also did a recent piece of market research, and we noticed in our sentiment to our market research that our efficacy perception is increasing and there's a gap between us and the competitor in our market research. So, it seems to confirm what you said. I'll hand over to Caroline on microcurrent.
Caroline Baumal: Thank you, Adam. Physicians are really excited about the micropurgatory data. And in showing them, they see the trend in the micropurgatory data that's followed over time and that it reaches this pre-specified endpoint. I think that most physicians, realize that micropurgatory in many ways is analogous to a visual field testing, and they appreciate that it shows benefit in a clinical trial. But in the real world, they like to use OCT, which also, has shown benefits using our AI algorithms combined with the University of Vienna. So, I think the fact that we have this prespecified endpoint though is very highly meaningful, and it will mostly be used today in clinical studies, although some people are using micropurgatory in the real world. In the real world, we can use imaging to show this to patients, and we have cases that we've shown to physicians. In fact, we showed one at ASRS where, a patient in the observed fellow eye, the geographic atrophy grew 3 times as much compared to the treated eye. So, cases like this are highly meaningful, and that was in Matt McCumber's video talk at ASMS.
Operator: Thank you. And one moment as we move on to our next question. Our next question is going to come from the line of Francois Brisebois with Oppenheimer. Your line is open. Please go ahead.
Francois Brisebois: Hi. Thanks for the question here. So, I was just wondering, so in terms of function we've discussed, but on convenience and the importance of that and the economic value, can you help us understand a little bit from the convenience. Is that as advantages to the physician as it is to the patient? I'm just trying to understand if convenience and economic value here have a correlation or not.
Cedric Francois: There's three pieces to that question. There's the convenience to the patient, convenience to the physician, and then the convenience, quite frankly to the payer. So, when we start with the convenience to the patient, having every other month dosing available is really, really important. Our competitor, sure there is some off-label use with every other month, but our competitor has only monthly. We're going to find out at the end of this year if they actually ever get every other month in their label. This is a huge point of differentiation that we will benefit meaningfully from should end up the way we think. The advantage to physicians of every other month is, again, the flexibility. And I'm going to let Caroline answer like her view on that and then have Adam dive into the payer aspect of the cost -- the value.
Caroline Baumal: Certainly, to realize the anatomic benefits of SYFOVRE, we've seen that every other month dosing is meaningful. And I think that with our flexible every 25 days to 60 days in our label, patients can come every six to eight weeks and still realize these meaningful effects. And certainly, in the US, physicians love to have that plus minus one to two weeks with their dosing. And it's more likely for patients to come in and complete this. We know that with monthly dosing from our anti-VEGF experience, it's really very, very difficult to complete that and patients will often drop out because they cannot maintain that. Adam?
Adam Townsend: So obviously, we were we're thrilled that some payers are starting to look at this category and selecting SYFOVRE referred choice. So, this decision was basically made on its robust efficacy profile and particularly the increasing effects over time. And I think it's really basically simple. SYFOVRE is efficacious with monthly and every other month doses, and this is good for patients and is economically supportive for the health plan. And I think that's going to be important for us as this market continues to grow and become bigger.
Cedric Francois: And context there is that the flexibility is everything. Some patients with aggressive lesions want to be dosed monthly. We have seen very clearly in GALE as well that there are advantages to treating monthly. I mean, it is more intense from a dosing perspective of course, but in terms of reducing the lesion growth, there is an advantage to monthly. So that flexibility, the huge amount of data that we have both in its absolute but also longitudinally over time. We have three years now, we will have more data coming. All of that's incredibly valuable.
Francois Brisebois: And just lastly on the VALIANT data, just because it's coming up very shortly here. You guys discussed in terms of success and expectations stats on the primary, but on the secondary in terms of -- is this the positive trend on some secondary endpoints or all? And is this what the regulators need to see from conversations? They're just trying to understand more on the secondary endpoints and points here.
Cedric Francois: The secondary endpoints need to trend supportive of the primary. We have seen this with [indiscernible], where none of the secondary endpoints were met. But where we believe there is still a path forward for [indiscernible]. They were specifically asked to submit the data at one year as you may recall after having the six-month primary endpoint. Those are all things, secondary endpoints are more contextual, but very important to provide support to what we measure with the primary endpoint and the protein area reductions.
Operator: Thank you. And one moment as we move on to our next question. Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open. Please go ahead.
Douglas Tsao: Hi. Good morning. Thanks for taking the questions. I'm just curious, Adam, in terms of the patients that are now being treated, I think in the past you indicated that like 90% of them were already on the books of retina specialists. I'm just curious if that continues to be the case. And then in terms of the DTC work that you have done, for the most part, I think the Henry Winkler campaign has sort of been an unbranded campaign. Does there come a point where you might consider, now that you're quote on sort of in Phase 2, switch to a branded DTC effort to sort of focus on the competitive dynamics and the attributes of SYFOVRE versus Izervay?
Adam Townsend: Yes. Thanks, Doug. So yes, this is obviously a large and growing market with 13% market penetration for the current approved therapies. And most of those patients, in fact, the vast majority of those patients were already on the books of retina specialists. So, they're tapping into the patients that have GA that they were perhaps seeing that had other complications, for example. One thing, Phase 2 of our plan is super critical and DTC is also a part of it, is that we are going to educate ophthalmologists and optometrists on geographic atrophy as a disease. And once you start to educate those physicians, they will be able to potentially refer viable patients to retina specialists for treatment. We see this as a really big market, and actually facilitating that education is only going to help us. So, DTC, Doug, yes, Henry Winkler was disease education. It was incredibly well received by patients, but also by physicians. We did transition as part of Phase 2 to branded DTC. So, Henry was educating the world about go and get your eyes checked. And branded DTC is talking about SYFOVRE and the benefits of the efficacy that SYFOVRE does. So that patients are educated on the disease and then they can go and ask a physician to have a conversation about something. As we progress, moving forward, we're going to push DTC with a real strong approach on actual SYFOVRE and there's some exciting things happening with Henry moving forward.
Douglas Tsao: Great. Thank you so much.
Operator: Thank you. And one moment as we move on to our next question. Our next question comes from the line of Biren Amin with Piper Sandler. Your line is open. Please go ahead.
Biren Amin: Yes. Hi, guys. Thanks for taking my question. Maybe, if I could start with the competitive dynamic. Astellas earlier today on their call stated that they're seeing eye survey capturing a majority of new patients starts. Are you seeing similar trends from your treatment use and market research data?
Cedric Francois: Thank you. Go ahead.
Adam Townsend: Yes. So, we are seeing through our dataset, which is not market research. We use a dataset that actually tracks vials into a physician site and then into a patient. So, we believe in the robustness of this, but we could do market research. And I think you get some bias when you do market research. And with the headwinds the competitors have, we were still maintaining approximately 50% share of new starts. And I think that's really, really strong considering it was the quarter of their J-Code. So that's how we look at the data set. We believe 75% market share of total market is a very robust number, and we look to the future of how big this market can be and being the number one GA product in it.
Biren Amin: Great. That's helpful in terms of data point. And then maybe if I could have a follow-up. So, on the quarter, it seems commercial units grew about 10% quarter-over-quarter if you take out samples, but sales grew about 12% quarter-over-quarter. So, is the remainder from lower gross to net in the quarter? And what should we expect for gross to net for the 3rd quarter?
Cedric Francois: Sure. Thanks, Biren. So gross to net, obviously, we don't say exactly what gross to net is. It did go up slightly this quarter, but was really well within the range of where it was last quarter. And in terms of the files out, that those are the accurate numbers, and we don't tag on four numbers.
Operator: Thank you. And one moment. And our last question is going to come from the line of Graig Suvannavejh with Mizuho Securities. Your line is open. Please go ahead.
Graig Suvannavejh: Thanks. Thank you for taking my question. I just wanted to follow-up on earlier in the year comments around seasonality and how that impacted the Q1 in particular. I'm just wondering as you've got Q2 now behind you, if you can provide us any commentary on what you're expecting, if anything, around seasonality impacts in the third quarter and fourth quarter just as we think about modeling, SYFOVRE revenue on a go forward basis? Thanks.
Cedric Francois: Yes. Thanks for the question. So obviously seasonality is an important metric to measure here. Every time we go to a big retina conference like ASRS a couple of weeks ago, right, a large proportion of physicians are there. So, there are multiple meetings moving forward, where physicians will be attending those conferences and learning about our efficacy data. Caroline, anything you want to add from your retina physician perspective?
Caroline Baumal: That, the retina physicians are really looking forward. We have some upcoming exciting presentations, and they want to offer patients a product that's going to be effective with increasing effects over time. So, they are very motivated and, looking forward to working with us on analyzing the data.
Graig Suvannavejh: And just as a follow-up, is there anything on like purchasing patterns, seasonally, third quarter versus fourth quarter, bigger picture?
Cedric Francois: I don't think we've had enough experience yet to really say that, at least in our in terms of this market. Anti-VEGF, there isn't anything that stands out particularly. I mean obviously you have August and that can be a full month just because vacation is booked. There's nothing really dramatic.
Operator: Thank you. And I'm showing as I said, there is no further questions, and I would like to turn the conference back over to Cedric Francois for any further remarks.
Cedric Francois: Thank you, operator. Thank you everyone for joining us this morning. If you have any follow-up questions, please feel free to reach out to Meredith and we look forward to hearing and speaking with many of you today. Thank you.
Operator: This concludes today's conference call. Thank you for participating and you may now disconnect.
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