Everyone, thank you very much for your participation onto this announcement of our Q3 FY 2023 financial results and the December 31st, 2023. I really appreciate your participation, and I'm Ikeda. I would like to serve as a moderator. My name is Ikeda, Chief of Communications and IR Officer. We are going to have presentation first, followed by Q&A session. Japanese, English, simultaneous translation is available. However, for that translation, the accuracy is not guaranteed by Astellas. For the languages, please select the appropriate channel on the Zoom webinar screen. If you select the original language, you'll listen to the original language without hearing the translation. And today's presentation is based upon the material available on our website.
This material or representation by representatives for the company and answers and statement by representatives for the company in the Q&A session includes forward-looking statements based on assumptions and beliefs in light of the information currently available to management and subject to significant risks and uncertainties. Actual financial results may differ materially depending on the number of factors. They. Please do understand about that. They contain information on all pharmaceuticals, including compounds under development, but this information is not intended to make any representations or advertise advertisements regarding the efficacy or effectiveness. The participants here today is Atsushi Kitamura, Chief Financial Officer; Yoshitsugu Shitaka, Chief Scientific Officer; Tadaaki Taniguchi, Chief Medical Officer; Claus Zieler, our Chief Commercial Officer. We have all those four on the stage. Now, please start the presentation, Kitamura-san.
Hello, everyone. I'm Atsushi Kitamura from Astellas Pharma Inc. Thank you very much for joining our FY 2023 third quarter financial results announcement meeting of a very busy schedule today. This is a cautionary statement regarding forward-looking information. As this was explained by Ikeda earlier, I'm going to skip this page. Page 3 is the agenda for today. Starting from the next page, I will explain these topics in this order. On page 4, I will give you an overview of FY 2023 third quarter financial results. Revenue increased year-on-year, but was behind the full year forecast we revised in the second quarter. XTANDI and XOSPATA was in line with the full-year forecast, revised upward, in the second quarter. PADCEV was in line with the full-year forecast, revised significantly upward in the second quarter.
Also, potential peak sales forecast was revised upward, incorporating the robust results of EV-302 study. On the other hand, regarding VEOZAH, overall initiatives are progressing, but demand trails internal expectations. Full-year forecast was revised downward. Either way, demonstrated encouraging first full quarter performance since launch. This progress made us feel confident about its future growth. SG&A and R&D expenses were on track. Operating profit was behind the full-year forecast, mainly due to the performance of VEOZAH. Taking these factors into account, revenue and operating profit full-year forecast was revised downward. On page 5, I will explain FY 2023 third quarter financial results. Revenue increased to JPY 1,189.1 billion, up 2.1% year-on-year. The Forex had a positive impact of JPY 58.8 billion.
Core operating profit was JPY 149.6 billion, down by 36% year-on-year. The Forex had a positive impact of JPY 13.8 billion. Due to the impact of the acquisition of Iveric Bio, as well as LEXISCAN generic, core operating profit was significantly lower year-on-year. The bottom half of this page shows our full basis results. In the right bottom of the table, we included other expenses booked in the third quarter. In the third quarter, we booked JPY 18.4 billion as organizational restructuring cost on a global basis. This impact was already factored into our full-year forecast we revised in the first quarter. As a result, operating profit was JPY 74.1 billion, down by 59.1% year-on-year. Profit decreased to JPY 50.3 billion, down 65.3% year-on-year.
On page 6, I will explain XTANDI and XOSPATA business update. First, about XTANDI. Global sales increased to JPY 460 billion, up by 9% year-on-year, in line with the full-year forecast, revised upward in the second quarter. In the actual business performance, even excluding Forex impact, XTANDI achieved about 5% growth year-on-year. Sales expanded in all regions, and XTANDI is still growing more than 10 years on the market.... In FY 2023, we're expecting sales close to JPY 720 billion, exceeding the JPY 700 billion mark on a full-year basis. In the United States, based on EMBARK study results, M0 CSPC additional indication was approved in November last year. We are expecting contribution to future sales.
On the other hand, Medicare Part D redesign will start from January 2025 as one of the measures by the so-called IRA, Inflation Reduction Act. The redesign is expected to increase the amount to be paid by companies, and we are assuming impact on our sales. We are still examining the specific level of potential impact. We hope to provide guidance in Q4 earnings. Regarding XOSPATA, global sales increased to JPY 41.3 billion, up 14% year-on-year. In line with full-year forecast revised upward in the second quarter, they've expanded. XOSPATA is expanding steadily, even in the current indication. We are expecting the achievement of our full-year forecast. On page 7, I will explain PADCEV business update. PADCEV global sales increased substantially to JPY 55.6 billion, up by 68% year-on-year.
Performance is in line with our full-year forecast, which was revised upward by nearly JPY 20 billion in the second quarter. The United States, in particular, contributed the most to global sales expansion. This is driven by the market penetration of first-line cis-ineligible mUC, based on EV-103 study, approved in April last year. In addition, in December last year, first-line mUC additional indication was approved based on EV-302 study for both cis-eligible and cis-ineligible patients. What's noteworthy is an incredible speed up to approval. Approval was granted only two weeks after the FDA filing acceptance. We believe that FDA also highly evaluated the robust data of EV-302 study. We're expecting significant sales contribution in FY 2024 and beyond, driven by the penetration of the robust EV-302 study data and further expansion of eligible patient populations.
In Europe, reimbursement started in three new countries, including Spain, with a big market. We have obtained reimbursement in a total of 13 countries by now. We are expecting further sales contribution. Furthermore, we updated potential peak sales forecast for PADCEV. Incorporating the robust results of EV-302 study, which even exceeded our initial expectations, we revisited our market share assumptions. We made an upward revision of potential peak sales forecast from JPY 300 billion-JPY 400 billion to JPY 400 billion-JPY 500 billion. We will aim to achieve JPY 500 billion with PADCEV as an important growth driver. Peak sales forecast is disclosed as in-market sales, not Astellas revenue. This is calculated as a total of sales booked by Pfizer for the Americas, plus sales booked by Astellas for ex-Americas.
Indications in early clinical phase are not included in peak sales forecast, such as NMIBC, non-muscle invasive bladder cancer, and other solid tumors. So depending on the future progress, there can be an upside for peak sales forecast. Based on progress, we will also update you on peak sales forecast at an appropriate timing. Just for your reference, you can find the image of economic conditions with Pfizer in the right bottom of this page. Schemes vary slightly by region, but we are assuming profit sharing on a global basis. Both the current progress and the outlook are extremely positive. We are expecting PADCEV to serve as a solid growth driver in FY 2024 onwards. On page 8, I will explain a VEOZAH business update. Third quarter year-to-date sales were JPY 3.6 billion, or $25 million.
Overall initiatives are making steady progress, such as market access and DTC activities. We feel more confident about the future product potential of VEOZAH. On the other hand, with regards to FY 2023 initial uptake, demand trails internal expectations, and the actual results so far are behind our initial assumptions. There are two main factors for demand lower than expected. First, the impact of DTC activities we started in October last year onto the actual demand is lower than expected. The level of interest among consumers and HCPs is rising steadily with DTC activities. We are very confident about the direction of our initiatives. On the other hand, for women who have seen our DTC activities to actually ask HCPs about VEOZAH, the time frame is longer than our initial assumptions. As a result, it's taking longer to impact the demand increase.
Secondly, many HCPs feel that VEOZAH's current payer coverage is not enough. Total lives covered are expanding steadily, but based on market research, more HCPs than we assumed have a perception that the current coverage progress is not enough to actively prescribe VEOZAH, which is impacting the uptake. Full year forecast of $375 million we decided to keep in the second quarter, has been revised downward to $50 million by incorporating the demand ramp delay due to these factors, and by reassessing the timing and pace of the full-scale growth curve we expected in the fourth quarter. Next, I will explain the latest progress. As for market access, total lives covered expanded to about 35% as of the end of December last year. Payer discussions are ongoing right now. We are expecting over 50% payer coverage by the end of FY 2023.
Regarding the effectiveness of DTC activities, we have received a lot of positive response. The level of interest among consumers and HCPs is going up steadily compared to the time before the initiation of DTC activities. In particular, activation of consumers and HCPs is an important progress. According to market research, 70% of women reported high intent to ask HCPs about VEOZAH. Also, 76% of HCPs report they're extremely willing to prescribe VEOZAH. We believe activation is important for the growth of VEOZAH. We'd like to aim for further enhancement in this regard for the future as well. As for our future initiatives, in order to address HCPs' perception that payer coverage is not enough, we will promote information provision to HCPs by sales force in an active and timely manner on the progress of the expanding payer coverage.
In DTC activities, we will broadcast a VEOZAH TV spot focusing on the product brand during the Super Bowl in the United States. More than 100 million people watch the Super Bowl every year. Last year, we ran a VMS disease awareness-related TV commercial and received a lot of reaction. We are hoping to reproduce such success. Regarding the future outlook, we are expecting a further increase in the percentage of lives covered and continued momentum from commercial investments in FY 2024. Mid to long-term, peak sales outlook will be reviewed based on the progress of overcoming HCPs' perception that coverage is insufficient, and we will provide guidance at an appropriate timing. Lastly, update on Europe. We obtained approval in December last year, and the product was launched in a total of 7 countries, including Germany and UK.
We will aim to increase launched countries and obtain reimbursement in various markets. On page 9, I will explain IZERVAY business update. About the progress since launch, IZERVAY was launched in the United States in September last year. Sales in about 4 months since launch were JPY 5.3 billion. This is an encouraging performance after launch, despite being before permanent J-code and label update. This progress was great and made us feel more confident about its future growth. Since launch, more than 17,000 vials have been shipped and become available in over 920 retina accounts. In particular, the GATHER2 data released at AAO 2023 in November last year was highly evaluated by specialists, and accelerated growth in IZERVAY usage was confirmed after the presentation.
Based on the reported shipment volume data, we estimate market share in the third quarter period to be about 20%. Taking into account of the fact that it's just about four months since launch, we think this is an extremely positive number. Safety profile so far in the real-world settings has been consistent with clinical trial results, according to the report. We remain confident about the product profile of IZERVAY. Next, about DTC activities aiming to increase awareness of the IZERVAY product brand and GA as a disease, shown on the right-hand side of the page. Since the approval of IZERVAY, we have been rolling out branded campaign for IZERVAY. We have achieved 55% brand awareness among GA patients post-launch.
As for disease awareness campaign for GA, we formed partnership with two-time Emmy Award-winning actor, Eric Stonestreet, who shared his personal connection with GA in a peer effort. These initiatives turned out to be successful and contributed to 56% awareness of GA among dry AMD patients. Lastly, about the future outlook. We're expecting two major milestones in FY 2024. First, we received confirmation of permanent J-code, effective April 1 this year. The other is that we are anticipating approval of label update within FY 2024. We are expecting significant growth in FY 2024, driven by these upcoming milestones. Together with PADCEV and VEOZAH, we are expecting IZERVAY to contribute to sales as an important growth driver for the future. Next, on page 10, I will explain cost items.
As is shown in the table, cost of sales ratio was 18.4%, improving by 1 percentage point year-on-year and was on track.
... SG&A cost, excluding US extended co-promotion fees, increased by 20.4% year-on-year. When Forex impact was excluded, the year-on-year increase was 14.6%, or about JPY 49 billion. As main factors behind, the impact of Iveric Bio acquisition was about JPY 20 billion. VEOZAH-related sales promotion costs rose by about JPY 30 billion year-on-year. On the other hand, sales promotion costs related to mature products, such as mirabegron, decreased by about JPY 6 billion year-on-year. We reduced investments in mature products actively and allocated resources to important growth drivers we should invest in, such as IZERVAY and VEOZAH. We are on track in our spending. R&D expenditure increased by 5% year-on-year and increased by 1.6% when Forex impact was excluded. With the Iveric Bio acquisition, we booked R&D expenditure of about JPY 8 billion, and we use it as planned.
On page 11, I will explain the FY 2023 revised forecast. We have revised our full-year revenue forecast downward by JPY 46 billion to 1,562 billion yen, incorporating the current progress of VEOZAH. The foreign exchange rates and the revenue of products other than VEOZAH have not been revised from the full-year forecast disclosed in the second quarter. SG&A expenses are expected to be JPY 731 billion, a reduction of JPY 6 billion. In alignment with reassessing the timing and pace of demand ramp-up of VEOZAH, we have reviewed some investments timing that we had planned in this fiscal year. We will continue to invest to maximize the product value of VEOZAH, but we will do so after carefully examining the optimum timing for the greatest return on investment.
R&D expenses are expected to be JPY 286 billion, with a reduction of JPY 4 billion. The production cost of commercial inventory of IZERVAY, which was included in R&D expenses in the second quarter, will be recognized as inventory assets as a result of our serious re-examination of its accounting treatment, and the impact of this change has been incorporated. As a result of the above cost review, the impact of the downward revision of VEOZAH has been partially mitigated, and the operating profit is expected to be JPY 164 billion. On a full basis, operating profit is estimated to be JPY 83 billion, mainly due to the core base revision. From here, I will explain our initiatives for sustainable growth. Page 13 summarizes the main updates regarding R&D since the last financial announcement.
Over the past three months, there have been a number of important progress, particularly with the regulatory submission for XTANDI and key strategic products. Details are provided in the following slides. Page 14. Here I describe the progress of the key events expected in FY 2023 for XTANDI and key strategic products. Progress since the last announcement is shown in red. XTANDI received approval in the US in November last year for the additional indication of M0 CSPC, non-metastatic castration-sensitive prostate cancer with a high risk of biochemical recurrence based on the EMBARK study. Regarding PADCEV, based on the EV-302 study, for the additional indication of first-line treatment of locally advanced or metastatic urothelial carcinoma, the filing in the US was accepted in November last year, and the approval was granted in December.
The filing for additional indications in Europe and Japan were also accepted in January. As for zolbetuximab, in January, we received a complete response letter from the U.S. FDA. I'll provide an update about this later in this presentation. VEOZAH was approved in Europe last December. For IZERVAY, we submitted a U.S. label update application in January based on 24-month data from the GATHER2 study. Other updates are listed outside of the chart. For VEOZAH, we will conduct phase three studies with the aim of regulatory submission in Japan. STARLIGHT 2, a pivotal study, and STARLIGHT 3 to evaluate the long-term safety, will be started in the fourth quarter.
Regarding XOSPATA, after reviewing the top-line results of the phase 3 MORPHO study for post-HSCT maintenance acute myeloid leukemia, together with additional analysis and consideration, we have decided to discontinue the development based on the result of this study. By accelerating the implementation of measures in each project, we were able to accomplish all the key events planned for FY2023 as of January. Page 15. We have made progress in the late-stage pipeline, with 4 regulatory approvals for new indication or region received during the quarter. I will discuss these in more detail. XTANDI, it is the first novel hormonal therapy receiving U.S. FDA approval for M0 CSPC. Based on the result of the EMBARK study, XTANDI is now approved for monotherapy, as well as combination with a gonadotropin-releasing hormone analog.
Regarding the addition of new indication for PADCEV, we expect that this will be a new treatment option to transform the current standard of care for decades, and it will bring significant value to patients in the first-line treatment of locally advanced or metastatic urothelial carcinoma. In addition, as I mentioned earlier, PADCEV was approved in less than 3 months after the top-line results readout of EV-302 study, and incredibly, only 2 weeks after the sBLA accepted by FDA. VEOZAH was also approved in Europe as the first-in-class non-hormonal treatment. Vasomotor symptoms associated with menopause are known to be a common medical need, not only in the U.S., but in many other countries as well, and this approval gives us the opportunity to serve more women suffering from this condition. CRESEMBA has an additional indication for pediatric patients with very high medical needs.
In addition, pediatric exclusivity was granted by the FDA, extending its market exclusivity period by six months in the US. We hope that these achievements will help maximize the value of each product. On page 16, I will provide an update on the status of zolbetuximab. In early January, we received a Complete Response Letter from the FDA, informing us that the FDA could not approve zolbetuximab by the target date due to unresolved deficiencies following a pre-license inspection of the contract manufacturing organizations or CMO facility. On the other hand, the FDA has not raised any concerns related to clinical data and is not requesting any additional clinical studies. Let me explain our action plan in light of this situation using the diagram in the middle. We are currently working closely with the FDA and the CMO as well to address the findings.
Once Astellas confirms that the CMO's response is complete, we will resubmit the BLA, and a new PDUFA date will be identified upon FDA acceptance. The FDA will then conduct an inspection of the facility and decide whether or not approval is granted. The target date for BLA resubmission is the first quarter of FY 2024. In parallel to that, reviews of applications outside of the U.S. are continuing as planned. Regulatory agencies around the world conduct their reviews independently, and the review decisions are based on the different requirements and expectations of each regulatory agency. This incurs no impact on other Astellas products. We will keep you updated on any developments as they occur. On page 17, I will provide an overview of the current status of the focus area approach projects in clinical phase.
There have been no major changes in the past three months, and each project continues to progress in clinical studies. Of this, ASP1570 and ASP2138 in primary focus immuno-oncology, and ASP3082 in targeted protein degradation, are aiming to obtain early data readouts in a phase one monotherapy dose escalation study ongoing during FY 2023. We are prioritizing these three projects as the lead projects for each approach and expect to obtain data that will lead to a POC in FY 2024 or later. Since the studies are still ongoing, we are unable to provide specific status at this time, but we will provide updates as soon as they become available at an appropriate timing, such as when we announce financial results.
On page 18, I will explain recent examples of open innovation initiatives, such as the activities at research stage and at early development stage. As part of activities at research stage, we focused on incorporating external innovation and co-creation through collaborations with academia and other companies, and the contributions to life science ecosystems. As part of these efforts, we are leveraging open laboratories and have established SakuLab- Tsukuba and TME iLab in Tsukuba and Kashiwanoha areas in Japan. SakuLab- Tsukuba is an open innovation center established in the Astellas Tsukuba Research Center and is equipped with experimental facilities that can be used immediately after move in. Academia and startups that move in here will have the opportunity to network with other users and with Astellas researchers, in addition to support from various Astellas experts.
The TME iLab was established in the Kashiwanoha area as an open innovation center for cancer microenvironments, an issue in interactive cancer, where researchers from inside and outside of the company can freely discuss and advance their research. The Kashino, or Kashiwanoha area is in close proximity to the National Cancer Center and many of Japanese leading advanced medical facilities in academia, and we expect to promote collaboration by maximizing the advantage of this. On the right side of slide, as activities are early development stage, we have entered into a five-year strategic collaboration with Mass General Brigham, MGB. MGB is based in Boston and provides medical education as a teaching hospital at Harvard University. At the same time, MGB is known as one of the top biomedical research institutions in the world, conducting a wide range of translational and exploratory research.
Through this collaboration, the two companies aim to combine their expertise and knowledge to accelerate the early development of innovative therapies. The collaboration has agreed to initially focus on Astellas' core R&D areas of oncology, rare diseases, and cellular medicine, gene therapy. We expect that partnering with a highly specialized academic institution such as MGB will help us to better understand disease and modalities, optimize clinical trials, and accelerate the early development of relevant primary focus areas. We also expect that Astellas' presence in Boston area, one of the world's leading life science area, will be further reinforced, which creates new opportunities for open innovation. On page 19, I will explain a summary of our progress to date in FY2023 and our outlook.
So far in FY 2023, revenue and operating profit have been below our initial forecast due to the LEXISCAN generics and Iveric Bio acquisition, as well as lower-than-expected progress in VEOZAH. On the other hand, we made significant progress in the development of key strategic products, including the launch of VEOZAH and IZERVAY, and the new indication of PADCEV. We have achieved a number of important milestones, which we expect to become full-fledged growth drivers from FY 2024 onwards. VEOZAH has been slow to ramp up due to the fact that many physicians feel that insurance coverage is insufficient, which is a barrier to prescribing. In response, we will work to further expand insurance coverage and promote the active and timely provision of information to physicians, which will lead to full-scale growth.
In addition, while ensuring investment in growth drivers, we have begun considering various measures to improve margins, strictly control expenses, and a revision of our planning process. As the CFO, it is my responsibility to ensure that these initiatives are carried out. We'll provide the details of these initiatives at an appropriate time in the future. As a result of the above, we expect to achieve an increase in revenue and profit in FY 2024. We hope to show that we will be able to achieve sustainable growth from FY 2024 onward, with setting FY 2023 as the turning point. That is all. Thank you very much for your attention.
Thank you very much. That's all for our presentation. Next, we'd like to entertain questions from the audience. If you have questions, please press the Raise Hand button at the bottom of your Zoom screen. If you are joining from your smartphone, if you tap Details, Raise Hand button will be shown, so please press it. MC is going to name you one by one. If your name is called, please unmute yourself on your screen, and please mention your name and affiliation, and then ask your questions. Questions, please. Thank you for waiting. Mr. Yamaguchi from Citigroup Securities, please. Mr. Yamaguchi, please? Mr. Yamaguchi, you may be on mute. I have unmuted myself. Yamaguchi speaking. Now we can hear you. Sorry for the inconvenience. Not at all. I have a few questions about VEOZAH. First, payer coverage is an issue, as you mentioned.
Right now, payer coverage is not making progress. There is a delay. What's the biggest reason behind? That's my first question. I have a few questions about VEOZAH, so I will ask later. What's the reason why there's no progress in the payer coverage? Number two, patients' awareness is increasing with DTC, but they are not making visit to HCPs. Why? That's my second question. Thirdly, you are going to examine the details from now on. At what timing are you going to examine the details? So these are my three questions about VEOZAH.
Thank you very much for your question. First of all, I'd like to briefly respond, then, Claus, will make additional comments afterwards. First of all, payer coverage for VEOZAH, it's not really delayed, but as of the end of December last year, we made progress up to 35%, and this year, over 50%. So we are making progress as planned. But on the other hand, we are making progress, but from HCP's perspective, there may be no progress. There is such a perception among HCPs. So...
... We'd like to provide information in a timely fashion that we are making progress. We need to do these activities. So, it's not behind, but, we are making progress in line with the plan, but we have not been able to overcome all their perception. As for DTC awareness, it's on the rise, but, why, it's not reflected onto the actual demand? There are two major things, in our opinion. First, looking at, DTC, people will become interested, in, VEOZAH, and they may want to use it. I'm talking about women, and they go to HCPs, to get the prescription. We thought that it's going to take about two months, but actually it's taking, longer in reality. One more point. The physician's HCP prescription, it may be difficult to prescribe, right now.
Because of, there is such a perception, they are not prescribing so much. As for the timing, to examine the details of the volume and sales, there are a few things I'd like to mention. First, we will implement the action, including payer coverage, when it's going to increase exceeding 50%. And then, what way, the physicians and HCPs perception will change, we have to identify. Claus, anything to add from you?
Yes. Thank you for your question, Yamaguchi-san. I, I would like to emphasize what, Atsushi just said. Our payer coverage is actually progressing to plan. We, we have said in the last call and in the call, call before that, that we were aiming to reach more than 50% payer coverage by the end of the fiscal year. By the end of December, we had reached 35%. By the end of January, we're already north of 40%. So we're fully on track if you draw a line in terms of the payer coverage that we set out to achieve. However, we're, we're seeing that HCP perception is lagging the real coverage. So that's an opportunity for us, with our sales force, to educate physicians on the options for coverage that exist today.
Our sales force is doing that, and we are reinforcing our efforts there. So there's a difference between payer coverage progressing and the perception in the HCP community, which is not up to date with that progressing coverage. So that's the issue that we have to address now. As to the DTC, again, as Atsushi said, we're actually very, very happy with how the DTC is working. You can see it in on the page that Atsushi presented with the increase in awareness, both in consumers and in HCPs. But we're particularly encouraged with the intention. So the increase in high intent of women, that increased from 50% in September to 70% in December. That's a 20 percentage point increase in one quarter. And the same for the HCPs, yeah?
From the mid-sixties, we had 64% extremely willing to prescribe in September. That's increased to 76% in December. Again, more than 10 percentage points increase. So the DTC is working, but we are seeing delays in... For instance, in the time it takes women to get an appointment with their HCP. That's more than 40 days. So the delay in women who want to consult, being able to consult and get a prescription from their HCP.
Thank you very much. Then let me ask you one additional question. That's regarding the payer coverage; I understand about that quite well. Thank you. So your view and the HCP's view or perceptions are different. So to put it in a reverse way, of course, education is important, but HCP perception—what is the percentage of the physicians consider that the coverage is sufficient? This is the opposite way to ask you the question.
That's exactly right, Yamaguchi-san. We're asking the same question right now. Let us get back to you next quarter with more details on that, because we're doing some research on exactly the question-
What's the threshold?
Yes, yes.
where HCP say, "Oh, yes, now I feel free to, to prescribe." So let us wait for that data to come in, and we'll share that with you next call.
Thank you. One more question, just briefly. You have CSP, which is ongoing. As of late, VEOZAH, slightly behind. You were revisiting our peak annual sales forecast. The CSP as a whole is going to be reviewed?
...Do you have such, opinion?
Thank you for your question. As of now, CSP2021, we haven't changed the plan. We would like to work on it rigorously. When we announced the second quarter results, IZERVAY in 2025, including the amortization of intangible assets, including that for IZERVAY, considering that impact, core operating profit 30% can be difficult to achieve. On the other hand, IZERVAY and other products, they will continue to grow in 2026 and beyond XTANDI's LOE. After XTANDI LOE, for sustainable growth, these are important factors, so we will continue to work on these products. VEOZAH figures, this will have a big impact on the achievement of CSP2021. As Claus said before, we have to identify the progress of VEOZAH, and we'd like to closely watch the situation.
Thank you very much. That's all my questions. Thank you.
Thank you very much. Next, Daiwa Securities, Mr. Hashiguchi, please.
Hashiguchi speaking. Thank you very much. Thank you. First question is about VEOZAH. Information provision to HCPs will be reinforced, and then these issues could be resolved. Do you think that it's going to be happening? Payer coverage and the conditions for patients to receive payer coverage, if these conditions are complicated, you have to simplify these conditions, otherwise the coverage ratio may increase. You may not be able to resolve the issues. So what kind of patients and what kind of background of patients can receive coverage? In order to ease the conditions, rebate can be expanded. To simplify the coverage, what's your view about the simplification of this?
Thank you very much. Claus is going to respond.
Thank you, Hashiguchi-san. I don't think we are changing our approach to payers at this point in time. There's no need for us to do rebating the way you suggested. Our payer coverage is progressing. It's progressing according to plan. Yes, HCPs have not perceived that yet, but they will over time. We know that HCP perception tends to lag this kind of progress, because, of course, it takes time for them to be informed when a payer coverage contract comes in. But we are continuing exactly on the same approach, and we will, we're very confident that we will deliver on the more than 50% payer coverage that we aimed to, that we aimed for by the end of fiscal 2023.
So, I would suggest that, next quarter, when we talk again, we concentrate on the question of: Has HCP perception caught up with the progress that we're making on payer coverage? Rather than now addressing the question of what changes do we have to make to our approach to payer coverage.
Thank you very much. Thank you very much. Second question is about IZERVAY, about the update of the label. Toward the back side of the material, it says that in January, the submission is done for the label update. But what kind of the contents of this label update, and to what extent of impact of that is likely to be incurred? Would you please explain about them?
At AAO, the data is presented, and according to that, from the beginning, once the 2 months of the administration becomes possible, or 12 months, the restriction of the administration is going to be now lifted up and released. Seemingly, there might be certain risks for that, but would you please explain your view about that? IZERVAY labeling update, first of all, briefly, I'd like to explain. After that, Taniguchi is going to explain you the details. What we are aiming at with this update is the restriction of duration of administration, which is currently 12 months. That is what we would like to lift up, and also once monthly schedule is what we would like to extend to once in 2 months.
Of course, ultimately, what kind of level we can gain is all depending on the authority review, so we just have to wait. However, our intention is just what I mentioned.
Thank you very much.
Let me make some additional comments. For IZERVAY, GATHER2 study is basically, I believe, what you are talking about. And a GATHER2 study itself is a 24-month study. And this is, this shows the separation of the geographic atrophy, which is, statistically and also clinically, significant. So IZERVAY is the very first, therapy showing that level of the efficacies. With using that data, therefore, just like Kitamura explained, in January, we did a resubmission for the label update. So first, this, two, 12-month restriction of the administration is intended to be extended to 24 months, and on top of once a monthly data, once in two months data is now submitted. And so that both way of the, administration is possible, we are now trying to update at the level.
Of course, the final result is depending on the outcome of the authority review, so I'm not going to talk about that, but the review is ongoing currently. Thank you very much. So once in two months, in the GATHER2 study. Well, the first one's monthly, and from the mid, it was switched to once in two months, and there was no data that administration is once in two months from the beginning. But your submission, resubmission, is targeting the once two-month administration from the very beginning of the treatment. Well, ultimately, of course, we have to do the discussion with the authority, but we are providing the GATHER2 data. And at the end of what is going to happen can be updated later on. Thank you very much. That's all.
Next, Morgan Stanley MUFG Securities, Mr. Muraoka, please.
Hello? Muraoka from Morgan Stanley. Can you hear me?
Yes, we can hear you.
Thank you very much.
I also have a question about VEOZAH and IZERVAY. First, about VEOZAH. Prescription will start in two months, but it's taking three months, as was presented. In other words, your sales plan, according to your sales plan for this fiscal year, it's going to increase towards the end. If it's behind in January-March period, it's going to increase, and then there's going to be a faster increase from April-June. It's just the timing being shifted at a later time point. Is that the right picture I can draw? Can I have such a simplified understanding? For example, according to the table you showed before, you need to sell JPY 40 billion in April-June period. Do you still have such a plan? That's my first question.
Regarding VEOZAH, I'd like to briefly comment. Regarding the initial forecast for FY 2023, before starting DTC activities, we wanted to sell a certain volume, and after DTC activity initiation, relatively rapidly, it will drive the actual demand. These were assumptions. Regarding the first point in the previous call, it didn't come so much. Now, regarding the pickup after the initiation of DTC activities, as you pointed out, the timing of resulting in actual demand is shifted and being delayed. And HCP's perception may be a barrier to prescription, so there is one additional parameter. So what is going to happen to this is something we have to watch.
Thank you very much. HCP's perception, you are talking about it continuously. Have you missed any other factors? No such possibility?
So this is Claus speaking. Thank you for your question, Muraoka-san. I do believe the two factors that we have mentioned are the ones that play a role here. So one is the HCP perception on, of coverage, which is lagging behind our real progress, and the other is the timing in the activation of the DTC. So how much time when a woman decides to consult a physician, how much time does it take for her to make an appointment and to actually get a prescription? That timing is just longer than we had anticipated previously. So those are the two factors we've identified, and we believe that the HCP perception factor will normalize over time.
Of course, the question of how much time does it take for a woman to book an appointment, I think that's probably going to be a static factor from now on. I hope I answered your questions, but to confirm, those are the two factors we have identified.
Understood.
Thank you very much.
So, now, the second is going to be about IZERVAY.
So October, December, JPY 2.9 billion, so, compared to SYFOVRE, the situation is, getting better. There's a strong, growth in the US. But now question is about EU. SYFOVRE is facing difficulty in the European market. That is not their company's, reasons, but, the Apellis, the company is saying this is due to the authority. So what about you, Claus? In the case of, in terms of the, European market, are you looking at it in the same way as Apellis, or do you think that is some sort of a misunderstanding, therefore, you can get the approval in the European market? And on top of that...
... the, there is JPY 150 billion other than US. So if you face a difficulty in Europe, to what extent is going, of the, impairment risk it will incur?
Thank you for the question. That is about the European approval, therefore, I make a brief explanation, which is followed by Taniguchi. Since February, a negative opinion is issued, and we have, of course, recognized that. We cannot assume the, decision by the authority, therefore, we, work, within the information, available of us now. But if we're looking at the, clinical trial, study, as you know, IZERVAY is aiming at the, GA, for which the treatment is not available these days. And the, consultation with the authority is on track.
But of course, we, we cannot assume what kind of judgment or decision they will make. I would like to make some addition just briefly. As Kitamura explained, European IZERVAY submission and actual review are ongoing. I cannot talk about other company's situation. However, for us, for IZERVAY, Japanese phase 3 pivotal study was conducted, and a GA, geographic atrophy, progress was suppressed at the 12-month point in a statistically significant manner, and this is only one kind of such track. And the data was announced in, in November, and 24 months post-administration, GA progress was statistically significantly suppressed. Again, in that sense, this is a very fast drug.
In a safety perspective, we have a consistent data, robust data, and looking at both GATHER 1 and GATHER 2 data, the data is consistent with the safety information that is already available. So ultimately, including Europe and looking at globally, this Japanese pivotal study, safety, and efficacy balance is reviewed for the final decision. So what we can say here is that in Europe, the review is ongoing in a smooth manner. Thank you very much. At least mention that the inconceivable outcome or endpoint was requested by the authority as a new ask. But your data shown is in line with the expectation or the request of the authority in Europe. Based upon the consultation with them, you understand it in that way, right?
Well, so far there is no critical point out or mentioning from the authority. There are 120 inquiries, and answers are prepared. Therefore, if we can make some update about this at an appropriate timing, I would like to inform that. Thank you very much. That's all.
Thank you very much.
Thank you very much. Next, Goldman Sachs Securities, Mr. Ueda, please.
My first question is about PADCEV. You made an upward revision of the peak sales forecast. The Forex assumptions have changed a lot from the previous time on a local currency basis. What's your view? What are the changes in your opinion on a local currency basis? EV-302 study based on that you explained the situation. So what's your opinion resulting in the upward revision of peak sales forecast?
Page thirty-five.
Thank you.
What has changed the peak sales forecast of PADCEV significantly, rather than Forex rates, it's EV-302 data, in our opinion. If you look at this page, you can see a large number of eligible patients. As for NMIBC, we were able to obtain approval, this is a big driver for us.
I think you have to think about PADCEV in three steps. First, we got approval of the second-line indication, yeah? So second line, a doctor had to treat first with basically with cisplatin or with avelumab. That was the basis of our launch. Then in April this year, only in the U.S., only in the U.S., we received approval of the EV-103, which is a first-line indication, but only for part of the population... only for the part of the population that is cisplatin ineligible, yeah? So that's only part of the first line indication. And that is what provided already such good growth in this year in the United States, and we updated you on that in the last quarterly call.
We revised our FY 2023 forecast upwards on the basis of that very strong uptake in that partial first-line indication in the US. Now, in combination with pembro, we have the full first-line patient population available to us. So both cisplatin ineligible, but also cisplatin eligible, yeah? That really opens up the whole field of first-line treatment for a doctor. And given that we had such a strong echo in the ESMO Congress when we presented the data to physicians, we really think that this has the potential to change practice in a very significant way. And that is what's causing now our optimism and our upward revision, 'cause we now have this very strong data for the entire first-line population that a doctor can see.
So I hope this stepwise fashion of thinking about the PADCEV patient populations helps on why we have updated you first with an upward revision for FY 2023 results in last quarter, based on fast uptake of EV-103, which is only partial first line. And now we are updating you for the peak sales because of the robust data of EV-302, which gives the doctor access to all patients in first line with PADCEV and pembro combination. So I hope that explains.
Thank you very much. Second question. Toward the end of the examination by Kitamura-san, the process of the planning is part of your consideration. The planning process change is part of your consideration, I think that's you mentioned. But currently, what kind of issues do you see for the planning process? And in what way you would like to revise? What's your perspective about this?
Thank you for the question. First of all, I'm not saying that the current way is not good at all, rather, that we would like to reinforce current process. Especially, regarding the new products, including timing, there are always uncertainties. So we would like to—we would like to look at them in a range or based upon scenario, and when we have, beforehand, what kind of actions we should make.
In that sense, the scenario planning is something we can review, and in a timely manner, we need to make the appropriate decision-making. And depending on the necessity, we are going to accelerate the reallocation of the resource. That's also something we'd like to do. So basically, it's about scenario setting and also the speed of decision-making. Those are something we see more room that we can work on to reinforce it further. That's all. Thank you very much. That's all from me.
Thank you very much. Next is JP Morgan. Wakao-san, please. Wakao speaking. Thank you very much. Can you hear me? Yes. Thank you. First, it's about VEOZAH. Thank you for the explanation so far. And there's a delay compared to the initial plan. I understand about that. And FY 2024, JPY 300 billion that you are...
25, excuse me, JPY 300 billion that you are aiming at, and I believe, currently it's very difficult to achieve. So how do you view about it? And, next is about how to use the expenses. For this fiscal year, partly you reduce some, but next fiscal year and afterwards, VEOZAH, SG&A, how you are going to allocate that? There's a delay, so you would like to catch it up. In that case, you think about increase of SG&A, or whether you are not going to increase that, with the efficient usage of the expenses, or there might be the reduction in SG&A overall? Thank you very much. I would like to ask Claus to answer this question.
So thank you, Wakao-san, for your question. You know, yes, we have a delay, but we're still very confident in the potential of this drug. There's a huge unmet medical need in this market, and we're tapping that unmet medical need as a pioneer. We're creating the market. That takes some time. So our investment will continue until we see that our assumptions may have to change. Right now, I can tell you our investment level is appropriate, both on the field force side and on the DTC side, and we intend to continue that also in the future, including in FY 2024, as appropriate, to drive the value of this brand. Let me just confirm, Wakao-san, whether I've answered your question?
Do it here, yes.
In other words, there's a possibility that you would increase the SG&A cost and so on, for next fiscal year and afterwards?
Our current investment in VEOZAH is appropriate. You know, barring, bar-
Understood.
Plans, I don't see movement up or down in a major way. Yeah. Does that clarify?
Maybe say it again.
Yes, very clear. Thank you very much. Now, second question is about the IZERVAY, competition. There is about 20% of the market share, but they are currently with the competition. Compared to that, what's your current status of your product? The market itself is growing, so it seems that there is no fierce competition about getting their market share. But, for SYFOVRE, how it's evaluated, how do you evaluate that compared to SYFOVRE in terms of they getting market share? Claus, could you answer this question?
So I would thank you again for your question. I would give you the following consideration. We've been on the market promoting IZERVAY since September. So within until end of Q3, fiscal year Q3, that gives us four months on the market? In the last three months, so in the full quarter, October, November, December, we achieved what we estimate to be a 20% market share. That's based on the public information available of what SYFOVRE has shipped and what we have shipped, and if we put all that together, we estimate approximately 20%. That's overall market share? Taking into account that we entered the market six months after SYFOVRE, that means the new two brand market share in the last quarter must have been significantly higher than 20%.
So our estimation is that we are extremely competitive in the new patient capture with IZERVAY, because that's the only way you would get a 20% market share within essentially the first full quarter on the market.
I might have missed, but I'd like to ask you the last question. So XOSPATA, Medicare Part D redesign was mentioned. I'd like to hear more about the redesign. Medicare Part D to start from 2025, and the impact on your products. Claus is going to respond.
So I believe Atsushi, when he explained, was referring to XTANDI, because that's the major impact we see on, from the Part D redesign, that the Biden administration has put into legislation. So when we think of Part D redesign, the first thing to consider is that this takes effect in calendar year 25, so from first of January 2025. So we are now talking about the fiscal year Q4 of FY 2024. So that's the first consideration. The second consideration is that this is a very complex change, which affects both the Medicare as a government institution, reimbursing. It also affects the plans in the United States, and it affects what manufacturers have to pay, and it affects what patients have to pay. So you have four factors going on at the same time, yeah?
Patients have to pay less, plans have to pay more, manufacturers have to pay more, and Medicare is shifting what they, what they pay. Trying to really estimate, pinpoint estimate, how all these factors play out, is going to be very, very difficult. So what we have done so far is just mathematical calculations based on the publicly available information from who pays more and who pays less. We have not simulated, or we're in the process of simulating, how does behavior now also change in the marketplace as patients pay less and other players have to pay more? That's a very, very difficult exercise to do.
Please, please understand that right now, all we are informing about is, you know, the factual mathematical calculation of what we know from the changes that kick in on first of January in 2025.
... So there can be quite a certain level of negative impact. Should we assume that? You're still calculating all the details, right? But do you have any assumption?
So from the simply mathematical calculations, we assume that not only Astellas, but all manufacturers will have a certain extent of negative impact affecting gross- to- net, yeah? But as I said, there may be counteracting factors based on how behaviors change in the market, which we cannot estimate at this point in time.
Understood. Thank you very much. That's all for me. Thank you. Thank you very much. Next, UBS, Haruta-san, please. Haruta speaking from UBS. Now, question is about IZERVAY, the vasculitis issue. There's one case of vasculitis in the past, but after that, there any such cases? Is there any report of vasculitis or so after that? If that happened, what kind of feedback did you get? In the case of SYFOVRE and IZERVAY as well, if the frequency is low because medical needs is high, the market itself is growing. Is there any feedback from the doctors? If there is any, I would like to learn about that. Thank you very much. As for the safety profile, it is consistent with the clinical study result.
And one case of There is one case of off-label usage, but the second case afterwards, retinal vasculitis was not reported. There was no post-launch adverse event report of such. So the result is consistent with the result we gained from the clinical trial. Anything else to be added? No. Thank you. That's all. Then complement inhibitor. For the mechanism itself in AAO questionnaire shows a bit of the negative way to look at it. Is there any change about that? AAO, there is a report about the negative perception on this complement inhibition. Is there any change about that? Let me respond to that. As Kitamura explained, I think the question is basically about the safety. But so far, for the IZERVAY, there is no report of retinal vasculitis at all.
In a clinical trial as well, well, we've done GATHER1 and GATHER2, and there is no report of the retinal vasculitis. That's where we are. The drug itself, in regarding IZERVAY, C5 is targeted. RNA aptamer is the modality, and other competitor is peptide. And us, this is the intraocular administration and the kit for that. There is the prep and provisioning. So there is such a difference. So although the same target is targeted, however, based upon the available information for us, it seems there is no negative impression onto our product. Understood. Thank you very much. And so zolbetuximab, CRL was received. There is a slight delay in your schedule, but as of now, peak sales impact is none, as of now.
This is, maybe about the situation after approval. For gastric cancer, CPS less than 5 is going to be the target in this market. Is that what you're going to target? Claudin 18.2 biomarker, and how are you going to increase the awareness of this? Do you have any information you can share right now? Thank you. Claus is going to respond.
Thank you. It's a very good question. So the companion diagnostics for the testing for claudin 18.2 varies considerably from market by market. We have markets, particularly in East Asia, where claudin 18.2 testing awareness is very high. And we do not foresee problems with including that in testing. We have other markets, more Western markets, where we have to educate doctors much more on claudin 18.2 testing. Now, the program we've designed addresses both the awareness with doctors once we're able to promote the product, but it also—we also have a program working with pathologists and the labs that have to do the testing. 'Cause you actually need the awareness on both sides, right?
You need it with the prescribing physician, you also need it with the pathologist and the lab that has to do the testing. So those programs are in place, and we are ready to educate physicians, as soon as we get approval.
Thank you very much. Regarding any comment on the patient segments?
Repeat your question, please.
Claudin 18.2 is going to be important. In particular, CPS 5 or less, under 5 is a target population which could enjoy benefit from your product. What do you think of it, this? Target population with a CPS under 5, is that the target population with your drug?
I mean, we will, we will target the population in accordance with our label. So, yes, we are targeting below 5, if that is your question. Now, if you want, if you're looking for specifics within that population, we, we would have to get back to you with more details. I'm, I'm, I'm sorry, maybe I'm not 100% understanding your question.
Thank you very much.
Thank you very much.
Next, Bank of America Securities, Mamegano-san, please.
Thank you very much. BofA, Mamegano is my name. Can you hear me?
Yes.
Yes.
Thank you very much for the confirmation. I have two questions. First of all, VEOZAH, this might be a big, a future thing. The competitor from Bayer and elinzanetant, the clinical trials said to be successful, and probably next year, it's going to be launched in the market. So what's your view about, the competition? The market is still on the process of the expansion. So this, competition is going to be work positively for your product. What kind of view do you have? And also, is there any benefit, for first comer or not? That's the first question.
Thank you. Probably, last time, Okamura mentioned the same kind of thing. With having the competition, there is both, positive and negative. First, the market is getting bigger. That is, one big positive impact.
And in that, the first, the market is getting bigger, and how we can gain the market share is one important thing. So, we would like to increase our own brand awareness, although we are not the first comer. Claus, do you have any additional comment? No? Thank you. That's all. Thank you very much. Second question, regarding earlier development, the early read data readout, you can get that for three projects within this fiscal year. So for this early read data, read early, data readout, you're going to... You are planning to get a POC. But for those, early, data read out, when they are going to be disclosed, when can we know about this, early data readout? Thank you for the question.
As we mentioned, it's appropriate timing, but Shitaka is here, Taniguchi is going to give you the response. Thank you. Regarding the early data readout, basically, phase 1 dose selection dose setting, ASP1570, ASP2138, and ASP3082. We are doing the dose selection study for those three. And based upon the result, I would like to decide the most appropriate dosage. We are on that phase now. So first, we decide the clinical dosage, and once that is fixed, we would like to consider about the disclosing that in some publication also. But as of now, we haven't decided when and which scientific congress we will present that or not. So I cannot give you any specific answer.
But for the early data readout, that is completely on the plan. Thank you very much.
Thank you very much, stop.
Thank you very much. Next, Sanford C. Bernstein. Ms. Sogi, please. Thank you very much. First, before asking questions, Kitamura-san, four months after you joined the company, this is your first earnings call. Business, and from a business, you're catching with these difficulties. I was surprised positively, so I wish you a good luck. I have high expectations in you. Thank you very much. I have a question about VEOZAH, two questions about VEOZAH and one question about IZERVAY. First, about VEOZAH, private health insurance coverage. So seven months after the launch, and between seven to nine months during this magic period—you need to increase the coverage, otherwise it's going to be difficult in the later period. This year, by the end of March, just 50% in private insurance coverage. I'm concerned about it.
Next year, next fiscal year and beyond, how much you can grow from 50%? And about VEOZAH, promotion costs may remain high for a long period of time. That's my concern. From last year, an increase of JPY 30 billion are due to VEOZAH. Considering this factor, this year, of course, DTC started in October and after, but on a full year, you are not doing activities on a full year basis. You have a lot of money for DTC activities. In 2024, JPY 50 billion or so may spent. It may not be over in just the 2024. Bayer's product will enter the market, and you will continue these activities further, then this product will be breakeven in 2026 or 2027, according to my assumption. I'd like to hear your view on this.
Last but not least, I have a question about IZERVAY. SYFOVRE, in February last year, was launched, on a full-year basis. $275 million were the sales, according to JP Morgan presentation. Given that factor, IZERVAY, $160 million or so could be reached by IZERVAY. But you mentioned JPY 11 billion, which is much lower than $160 million. Competitively, new-to-brand share is being captured by your product. Why, compared to SYFOVRE, it's lower?
Thank you for your question. First, about VEOZAH, two questions about VEOZAH and one question about IZERVAY. For the details, Claus is going to respond. But regarding IZERVAY, as we mentioned, from April and beyond, the J-code will become available and label update will be made and approved.
There is a room for a lot of growth. The numbers may look weaker, but next fiscal year and beyond, it's going to grow well.
Thank you, Sogi-san. Let me first add to the IZERVAY comment from Atsushi. I firmly believe that we are very competitive with our new patient capture with IZERVAY versus SYFOVRE. You have to consider that in a disease where there was no treatment, the first to market will capture the so-called bolus patients, so the patients that are waiting. That gives them a base that they can carry forward. Now, for us to capture, as I said, 20% of the overall market in the first full quarter after launch, our new brand capture has to be extremely competitive, yeah? It's difficult to estimate right now 'cause we don't have the data, but I think you're being a little bit too careful on what we are capturing in the US market with IZERVAY right now.
So that would be my IZERVAY comment. On VEOZAH, I believe your question was, when do we break even, and what's the investment going forward, and what's the curve? I would beg you for some patience as we figure that out. But again, I think you are being very critical with the numbers, and your projection of break even. I do think we will pleasantly surprise you with some news. But what we need to do before we can pleasantly surprise you is we need to understand exactly how the pickup curve in the next quarter or so really develops, because that gives us a robust basis for informing you on what is the trend that we anticipate for FY 2024 and beyond.
And I would like to wait for that data before we start talking about what's the right way, what's the year that we break even, and what's the projection of the sales. So if you permit me, let's try to debate that in three months' time.
That's great. Thank you, Claus. I actually have another question regarding the commercial health, the payer coverage.
So you're expecting that, you know, the coverage to achieve the 50%. But usually, you know, the coverage, the major boost of coverage should happen between seven and nine months after the launch. And that is exactly the time we are in right now. And I'm a little bit, you know, wondering how much more it would go after this 50%, after this, in a magic period of the seven to nine months.
Yeah. We are exactly in that period, that 7-9 months, as you said. So there are quite a few contract negotiations that are going on right now, yeah? I don't want to speculate, and I don't want to give information that's not appropriate. But, we are exactly in the period that you described with some negotiations going on. Which could make a major impact, yeah. So let's leave it at that for now, and let's talk in 3 months what progress we've made on the PS.
Great. Thank you very much.
Thank you very much. Thank you very much. We are a little behind, but I would like to take one more question. Nomura Securities, Mr. Matsubara, please. Matsubara from Nomura Securities, can you hear me? Yes. I have a question about IZERVAY. In your presentation, after GATHER2 study data presentation, our prescription increased, and the study said that compared to placebo, there was no improvement of visual acuity in GATHER2, but our GA area was suppressed, and also safety is highly evaluated. Secondly, about zolbetuximab, the re-examination period is up to Q2. But regarding the findings, the issues are going to be resolved, including 18.2, bispecific antibody is under development by you. So, how are we going to differentiate zolbetuximab as that antibody, bispecific antibody? This is about GATHER2 study.
Can you, Taniguchi is going to respond. Okay, first from me about IZERVAY. GATHER2 data was presented, and sales are improving, and the question is why? As we mentioned earlier, GATHER2 data is important because, as of 24 months, the primary endpoint, GA progression, was suppressed with statistically speaking for the first time. That's a very meaningful data in that regard. And as for safety, it's consistent with the past data. There was no onset of, or report of, retinal vasculitis, so the results were consistent with the past results. Physicians might have felt relieved by looking at that data, as we can imagine. Because of this, the results were taken positively. But how they captured the data will become available into the future as well. Next, about zolbetuximab.
CMO, contract manufacturing organization, with that vendor, the findings by FDA, we are discussing to address the findings as soon as possible. On the part of CMO, they also regard this as very important, and they are doing their best to address the situation. So as I mentioned before, next fiscal year, in the first quarter, we can resubmit our filing. That's what we are aiming for as we are proceeding with the discussions. ASP2138, claudin 18.2, and CD3 bispecific antibody, ASP2138. And how to differentiate this from zolbetuximab? That was your question, right? Claudin target is the same, but 2138 is T-cell engager, CD3 exists. So according to expectations, we have to look at the data from now on. But for more broader patient populations, this drug can become more meaningful.
Phase one study is ongoing right now, so we will look at the safety and efficacy to discuss how this drug is going to be used, or this drug can be used in combination, as well as the indications we are discussing right now. Once the future direction is determined, we'd like to share more with you. Understood. Thank you very much. Additionally, the visual acuity improvement by IZERVAY, is there any particular comment from the HCPs?
Putting aside if it is from doctors or not, but as you know, although it's a post-hoc analysis, but for IZERVAY, 12 months after the treatment, for example, visual acuity, there are more than 15 data improvements for the BCVA, and there is a 50% suppression. On top of the IZERVAY GATHER2 data is including the sub-analysis under the analysis, so we are looking at- So such kind of data is probably referred to by the HCPs as well.
Understood. Thank you very much. Thank you. We are behind the time to close this session. Therefore, with this, we would like to close today's earnings call. Thank you very much for your participation.