Thank you very much for joining with our 20, FY 2023 earnings call, despite of your busy schedule. I'm CYamaguchihief Communications and IR Officer Ikeda. I would like to serve as the moderator for today. Today, I will make presentation that is followed by Q&A session. The material is available on our website, and in line with that, we are going to give you the presentation, including the Q&A. The simultaneous translation of Japanese and English is provided. The accuracy of the translation is not going to be guaranteed by us. As for the language, from the Zoom webinar screen, on the menu, you can find the language. When you select the original language, in that case, you can listen to it without using the translation service.
For the material or presentation, and answers, and statement by the representatives for the company in the Q&A, includes forward-looking statements based on assumptions and the beliefs in light of the information currently available to management, subject to significant risks and uncertainties. Actual financial results may differ materially depending on number of factors. They contain information on pharmaceuticals, including compounds under development, but this information is not intended to make any representations or advertisement regarding the efficacy or effectiveness of these preparations. The participants who are here today is CEO, excuse me, President and Director, President and CEO, Naoki Okamura, CSCO, Chief Scientific Officer, Yoshitsugu Shitaka, Chief Medical Officer, CMO, Tadaaki Taniguchi. The Chief Commercial Officer, CCO, Klaus Zieler. Chief Financial Officer, CFO, Atsushi Kitamura. We have five here as representatives from the company.
Now, Okamura-san, please start your presentation.
Hello, everyone. I'm Naoki Okamura from Astellas Pharma Inc. Thank you very much for joining our FY 2023 financial results announcement meeting, out of a very busy schedule today. This is a cautionary statement regarding forward-looking information. As this was explained by Ikeda earlier, I'm not going to read this page. Page three is the agenda for today. Starting from the next page, I will explain these topics in this order. On page four, I will give you an overview of FY 2023 financial results. Revenue increased year-on-year and exceeded our full year forecast, revised in the third quarter. XTANDI sales increased by about JPY 90 billion year-on-year, contributing to the achievement of a full year forecast.
Sales of PADCEV, XOSPATA, VEOZAH, and IZERVAY combined, increased by about JPY 70 billion year on year, contributing greatly to sales expansion as growth drivers. SG&A costs increased year on year, mainly due to the impact of IVERIC bio acquisition and investments in growth drivers. We achieved efficient cost management through timely assessment of resources, and the expenditure was on track. Core operating profit decreased year on year, mainly due to the impact of IVERIC bio acquisition. On the other hand, core operating profit exceeded the full year forecast revised in the third quarter. On page five, I will explain FY 2023 financial results. Revenue increased to JPY 1,603.7 billion, up 5.6% year on year. We achieved 102.7% of our full year forecast.
Core operating profit was JPY 184.6 billion, down 35.6% year-on-year. We achieved 112.6% of our full year forecast. You can see the Forex impact on the right-hand side of the table. There was a positive impact on revenue by JPY 96.3 billion, and on core operating profit by JPY 19.1 billion. 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 fourth quarter. We booked JPY 56.3 billion impairment loss for intangible assets of AT-808 and Evrenzo. In addition, we booked JPY 8 billion due to fair value increase of contingent consideration for zolbetuximab.
As a result, operating profit was JPY 25.5 billion, down by 80.8% year-over-year. Profit decreased to JPY 17 billion, down 82.7% year-over-year. On page six, I will explain FY 2023 financial results of our main products. First, about XTANDI. Sales expanded in all regions, despite more than 10 years on the market. Global sales increased to JPY 750.5 billion, up by about JPY 90 billion, or 14% year-over-year. Even excluding Forex impact, XTANDI achieved about 6% growth year-over-year. In the United States, which is the biggest market, based on EMBARK study results, m0 CSPC additional indication was approved in November last year. We have been able to confirm the penetration of this additional indication and the ripple effect on other indications as well.
Volume, excluding the so-called PAP, Patient Assistance Program, grew steadily by 4% year-on-year. PADCEV global sales increased to JPY 85.4 billion, up by 92% year-on-year, realizing nearly twofold growth. Performance was in line with our full year forecast, which was revised significantly upward by nearly JPY 20 billion in the second quarter. In the United States, the market penetration of the first-line indication was a major driver. Demand more than doubled year-on-year. Also, NCCN guidelines, which many physicians are referring to when they decide prescription, were updated last month. The level of recommendation for PADCEV as a first-line treatment of MUC, was upgraded from Category 2 to the highest recommendation level, Category 1. Globally, as a whole, the number of launched country is increasing steadily. In FY 2023, PADCEV was launched in additional 14 countries.
The number of launched countries has expanded to 36 in total by now. Regarding XOSPATA, global sales increased to JPY 55.1 billion, up 18% year-on-year. Sales expanded in all regions, in line with the full year forecast, revised upward in the second quarter. Sales of VEOZAH reached JPY 7.3 billion, progressing in line with the forecast revised in the third quarter. Commercial lives covered, payer coverage, an important KPI for market access, expanded to 50% as planned as of the end of March. On the other hand, HCP's perception of VEOZAH access and affordability remains low, which is a barrier to prescription. I will talk about our future initiatives and outlook when I explain FY 2024 forecast. IZERVAY is growing at a speed faster than our expectations.
Sales reached JPY 2.1 billion, exceeding the full year forecast we announced after the launch in September last year. Accelerated momentum continues, and vial demand doubled from the third quarter to the fourth quarter. We estimate market share in the fourth quarter period to be about 25%. This is calculated based on the reported shipment volume data, as well as multiple market research. Given the fact that the competitive product was launched about six months earlier, we think this is a great achievement. More than 50,000 vials have been shipped since launched, and IZERVAY is now available in about 1,000 retina accounts. Post-marketing safety profile is reported to be consistent with the results of the clinical studies so far. The number of physicians highly evaluating the safety profile of IZERVAY is increasing steadily.
Sales of PADCEV, XOSPATA, VEOZAH, and IZERVAY, as mid- to long-term growth drivers, increased by about JPY 70 billion in total year-on-year. We are expecting further growth into the future as well. On page seven, I will explain cost items. Cost of sales ratio was 18.2%, improving by 0.7 percentage point year-on-year, mainly due to changes in product mix and was on track. SG&A cost, excluding US XTANDI co-promotion fees, increased by 19.9% year-on-year. When Forex impact was excluded, the year-on-year increase was 2.8%, or about JPY 58 billion. As main factors behind, SG&A cost increased by about JPY 31 billion year-on-year. Due to the impact of IVERIC bio acquisition, VEOZAH-related sales promotion costs rose by about JPY 40 billion year-on-year.
On the other hand, sales promotion costs related to mature products, such as Myrbetriq, decreased by about JPY 8 billion year-on-year. We achieved efficient cost management through timely assessment of resources. R&D expenditure increased by 6.5% year-on-year, mainly due to Forex impact and IVERIC bio acquisition. We were on track in our spending. From here on, I will explain our initiatives for sustainable growth. On page 9, you can find an overview of major quarterly updates related to R&D. I will explain the details of XTANDI strategic product and focus area approach on the following slides. In Rx+ program, we initiated pivotal study for regulatory submission in Japan for Bluestar digital therapeutics for diabetes. On page 10, I will explain key events achieved in FY 2023 for XTANDI and strategic products.
As an achievement in April, XTANDI was approved in Europe for the additional indication of m0 CSPC, with biochemical recurrence at high risk of metastasis based on EMBARK study. As for PADCEV, a submission in China was accepted in March for the additional indication of first-line locally advanced or metastatic urothelial cancer based on EV-302 study. Finally, was approved in Japan in March for CLDN18.2 positive unresectable, advanced or recurrent gastric cancer. As for IZERVAY, a submission for a label update was accepted in the United States based on 24-month data from GATHER2 study. As other updates, we achieved first subject, first treatment in phase III studies of VEOZAH, Starlight-II pivotal study for JNDA in Japan, and Starlight-III long-term safety study in the fourth quarter.
Also, towards a new additional indication, we decided to perform a phase III study for induced VMS in breast cancer patients on adjuvant endocrine therapy. We will give you an update after the specifics of the study are decided. In FY 2023, we achieved many important milestones, such as approval of VEOZAH, VYLOY, and IZERVAY, as well as approval of additional indications for XTANDI based on EMBARK study and PADCEV based on EV-302 study. We have made a lot of progress towards growth in FY 2024 onwards. On page 11, I will explain the update for the past three months with regards to the progress of Focus Area Approach projects in clinical trial.
Primary Focus project ASP2016 in genetic regulation, ASP2802 in immuno-oncology, and ASP4396 in targeted protein degradation, newly entered the clinical trial stage. I will explain the details of these projects on the following page. As for ASP1570, the first project described here for Primary Focus immuno-oncology and ASP3082 in targeted protein degradation, phase I dose escalation monotherapy cohort is ongoing. For both, no major issue, including safety, has been observed by now. The study of recommended dose is ongoing. The initiation of dose expansion cohort as the next step is expected in the first half of FY2024.
As for ASP 2138, the second from the top in immuno-oncology, dose expansion cohort has been initiated based on the data obtained from the phase I dose escalation monotherapy cohort. We have not made any decision about data presentation plan at congress and other forums for any of these yet. Once we make a decision, we will share that with you. As for ASP 2074, the third from the top in immuno-oncology, we decided to terminate the project based on the clinical study data obtained by now. Regarding ASP 0367 in primary focus mitochondria, we decided to terminate this program based on the clinical study data obtained by now. In this primary focus, multiple programs have been generated, but unfortunately, in any of these programs, we have not been able to demonstrate benefit in clinical study results.
Based on these circumstances, we decided to dissolve Primary Focus mitochondria. So far, we have obtained knowledge and experiences through drug discovery in mitochondria-related areas and new drug development for rare diseases. We will leverage this as important learnings and insights for evaluating disease areas where we will perform R&D in the future. On page 12, I will explain new clinical programs. ASP2016 is a recombinant AAV8 encoding human frataxin gene. This drug was created for cardiomyopathy as a target disease within 8808 gene therapy R&D program for various symptoms of Friedreich ataxia patients. Friedreich ataxia is a hereditary disease caused by frataxin gene mutation. Currently, there is no curative treatment. More than 60% of the patients develop cardiomyopathy, which is a leading cause of death.
ASP 2016 was granted Fast Track designation by U.S. FDA in March 2024. We are hoping that single dose will result in the long-term expression of frataxin in the heart to improve the disease conditions. ASP 2802 was created with Xyphos technology. This convertible CAR-T therapy has entered the clinical trial stage for the first time. It is comprised of autologous T-cells and MiCA body directed to CD20. MiCA body is a fusion protein which fuses a tumor antigen-recognizing antibody and an immune cell binding ligand protein. According to the convertible CAR system, activity can be controlled with MiCA body dose, so benefits such as less long-term toxicity and prolonged response are expected. ASP 2802, the first convertible CAR program, uses autologous cells harvested from patients.
We are hoping that these clinical studies will also inform the development of future allogeneic off-the-shelf programs. ASP 4396 is a protein degrader regarding KRAS, targeting KRAS G12D mutant, like ASP 3082. The target protein is the same with ASP 3082, but E3 ligase binder is different. With ASP 4396, we achieved first subject, first treatment in phase I study in April 2024, just 50 days after the acceptance of IND by FDA. Generally speaking, it takes about 3 months, so we achieved a much earlier timeline. By proceeding with the clinical study and accumulating data in parallel with ASP 3082, we are hoping that the development of targeted protein degradation platform will be enhanced....
On page 13, I'd like to review the progress of corporate strategic plan CSP 2021 so far, in line with the three performance goals. As for performance goal one, we achieved extremely promising results in EV-302 study for PADCEV above our expectations, and we feel more confident about the significant growth in the first line settings. On the other hand, VEOZAH uptake is below our original assumptions. In addition, as an external environment factor, Medicare Part D redesign will start from January 2025 as one of the measures by the so-called IRA, Inflation Reduction Act in the United States, which was not included in our original assumptions. This is expected to impact XTANDI sales in the United States in the future.
As a measure to secure revenue, we acquired IVERIC bio and a new growth driver, IZERVAY, which is growing at a speed higher than our expectations. Also, we are working on product value maximization through active life cycle management with indication expansion, including MIBC, muscle-invasive bladder cancer for PADCEV and pancreatic adenocarcinoma for VYLOY. Regarding performance goal 2, pipeline value, we started targeted protein degradation as a new primary focus, and multiple promising projects have been generated. On the other hand, POC has not been obtained yet in focus area projects so far. We are hoping that programs such as Potenza A, AVC, and FX322 would be launched early and contributed to revenue in 2030, as they were relatively advanced project as of 2021. But we decided to terminate these programs as we could not obtain clinical study results showing benefit.
In R&D, we are implementing a major reform of the organizational structure and operation, further strengthening the focused resource allocation to prioritize projects and working on the acceleration of POC judgment. Also, through the acquisition of Propeller Therapeutics, we added to our pipeline PRL-02, a next generation androgen biosynthesis inhibitor, in order to be able to make up for the termination and the delay of early stage development projects. As for performance goal 3, core operating profit margin, we are able to control cost to a certain extent, but we recognize it was not enough to offset investments in new launch products. Lexiscan generics have been launched earlier than expected, and we cannot rule out the possibility of mirabegron generic launches at risk. This is resulting in a major impact on our core operating profit.
From now on, we will review the allocation of our management resources in a timely fashion and implement more stringent cost control while securing investment for future growth. We will focus on optimized operations through digital as well. From here, I would like to explain about the FY 2024 forecast and CSP 2021 outlook. Slide 15. Before the FY 2024 forecast, I will explain the background of making that plan. Looking back at FY 2023, because of the entry of generic Lexiscan, the increase of expenses due to the acquisition of IVERIC bio, the lower than expected progress of VEOZAH, as well as the booking of impairment losses and others, we have made multiple downward revisions on both a core and a full basis. The management takes very seriously the fact that we were unable to meet the expectations of the investors as a result.
Therefore, we have analyzed various scenarios for our FY 2024 forecast and formulated a more balanced plan that is both ambitious and achievable, taking into account risks and opportunities. For the FY 2024 forecast, we've done a lot of different scenario analysis and, taking into account risks and opportunities, we formulated a more balanced plan that is both ambitious and achievable. First, we updated our sales outlook for VEOZAH. As a result, we have been revising our peak sales forecast. We are still... The next, we factored in the impact of generic entry of mirabegron in the U.S., as we were aware that generic companies were already moving toward a market launch. As we believe that the formulation patent for mirabegron is still valid, and we will continue to focus on the dispute.
On the other hand, we expect the impact of the entry of generic mirabegron in the U.S. on our revenue to be offset by the full-fledged growth of strategic products. In addition, we announced in a press release today that the definition of core basis has been changed to more adequately reflect the profitability from our core business. On a full basis, we factored in other expenses, such as impairment loss, in our initial forecast to reduce the impact of unexpected downward revisions during the period. There are no specific indications of impairment at this time, and the estimate is based on the actual other expenses recorded in the past and the balance of intangible assets. I will explain the detail from the following slides. Page 16. I will explain our outlook for oncology products in FY 2024. First of all, XTANDI.
We forecast XTANDI sales for FY 2024 to be JPY 757 billion, an increase of JPY 6.6 billion year-on-year. Global sales are expected to be at the same level as FY 2023, with ex-US offsetting the impact of the US IRA.
... While we expect growth in M0 CSPC prescriptions in the US, we anticipate a decline in the sales due to the three-month negative impact of IRA Medicare Part D redesign, scheduled to be effective in January 2025. That is around $50-$70 million impact. Outside the US, we expect sales to continue to grow, mainly due to the growth of M1 CSPC, metastatic castration-sensitive prostate cancer. XTANDI for FY 2024 is projected to be JPY 151.2 billion, a significant increase over JPY 65.9 billion year-on-year, and we expect progressive strong quarterly growth throughout the fiscal year. In the US, we expect that first-line indications will make a full contribution from the beginning to the end of the fiscal year.
We also expect to see, logistic effects from the NCCN guidelines updated on March, in March, as I mentioned earlier, and aim to position it as a new standard of care in first-line treatment. Outside of the US, we anticipate the potential approval of an additional indication for first-line therapy based on the EV-302 trial in Japan, the established markets and international markets by the end of the year, and sales are expected to accelerate in each region once approved. Also, continued launch and reimbursement of the second line and afterwards around the world is expected. XOSPATA's focus for FY 2024 is JPY 60 billion, an increase of JPY 4.9 billion year-on-year. We expect continued growth in existing markets, centered on growth in the established markets.
In the international market, we expect an increase in launched countries and reimbursement, which we expect will contribute to sales. VYLOY, which was approved in Japan last month, is factored in as a few billion JPY in FY 2024 forecast. In the first year of the launch, we will focus on the penetration of the CLDN18.2 testing, a new biomarker, so we expect a full-scale contribution to sales from FY 2025 onward. In Japan, we expect to launch in June. In the US established markets, international markets in China, the approvals are assumed to be in the second quarter and onward, and we expect a contribution to global sales.
In addition, pages 20, four through 27 of the appendix provide a summary of the FY 2023 results and FY 2024 forecast for each major product, so you can easily compare them. Slide 17 is our focus for VEOZAH and IZERVAY for FY 2024 and beyond. We expect a linear demand growth of VEOZAH throughout the year, with a forecast of JPY 28.3 billion in FY 2024, an increase of JPY 2 billion... JPY 21 billion yen on a year-on-year. We aim for over 80% of commercial lives, a key, a KPI, by the end of FY 2024. Physician perception of market access is related to both the quantity and quality of access, and once negative perceptions are formed, it takes time to improve.
While progress on access has steadily improved since the third quarter of 2023, perceptions have yet to improve, and it remains a barrier to prescribing the drug. Market research analysis indicates that a significant increase in coverage will improve perception, so we will continue to make maximum efforts to expand coverage throughout the fiscal year. We'll also work to improve patient and HCP activation through necessary investments, including DTC. On the other hand, we will continue to optimize HG and A as needed while keeping ROI in mind. In addition to our FY 2024 forecast, we have updated our peak sales forecast.
Based on the learnings and data obtained since the launch in May last year, as well as the latest market research, we have revised our initial assumptions and lowered our peak sales forecast from the previous range of JPY 300 billion-JPY 500 billion to the range of JPY 150 billion-JPY 250 billion. The original assumptions were based on pre-launch market research. The original assumptions were based on pre-launch market research, but we updated the assumptions based on the findings and data obtained after the launch. Downward revision is mainly due to changes in assumptions for access and price sensitivity, treatment rate, and our class share. For access and price sensitivity, we have made more stringent assumptions to reflect the reality of plan type and patient sensitivity to price.
The treatment rate focus has been revised downward to reflect the actual treatment rate in the VMS market as a whole, not just for VEOZAH. We have also changed our outlook for the share of the NK class in the VMS market that we expect to gain. Although we have lowered our peak sales forecast, we still expect a potential of more than JPY 150 billion, and we continue to see this as an important growth driver. We will take necessary actions to achieve new peak sales. IZERVAY's focus for FY 2024 is JPY 46.4 billion, an increase of JPY 34.3 billion year-on-year, and we expect full-scale sales expansion. The J-code cover, which started on schedule on April 1, and we expect to update the label by the end of the fiscal year.
We are confident in our ability to grow, as we are already seeing signs of an increasing prescribing trend, not only from existing prescribers, but also from physicians who began prescribing after waiting for J-code coverage to become available. In addition to our regular sales promotion activities, we will continue to conduct disease awareness campaigns aimed at expanding the market and increasing awareness of the IZERVAY brand. We expect quarterly sales growth throughout the fiscal year, and we are targeting a total patient share of about 40% by the end of FY 2024. Finally, the future outlook. We are progressing as expected toward our forecast of JPY 100 billion or more for FY 2025, which we announced in our second quarter results.
We expect sales to significantly outpace expenses, and we look forward to a full-fledged contribution to profits in the future. Page 18. I would like to explain some of the key events we expect in FY 2024 for XTANDI and other strategic products. For XTANDI, we expect a decision from the Chinese regulatory authorities in the third quarter on its application for an additional indication for M1 CSPC, based on the China ARCHES study. Regarding PADCEV, we expect regulatory decisions in the second quarter for the second-line and beyond metastatic urothelial carcinoma, based on EV-203 in China, and the third quarter for first-line metastatic urothelial carcinoma in Japan and Europe. VYLOY is on track to respond to the complete response letter received from the U.S. FDA in January, and plans to re-submit the application in the first quarter.
If accepted, a decision is expected in the second or the third quarter, depending on the classification of the reapplication, as determined by the FDA. The regulatory decisions in other regions are expected in the second half of FY 2024 in Europe and in the fourth quarter in China. We currently expect top-line results from the phase 2 study in pancreatic adenocarcinoma to be available in the fourth quarter as of now. If the data are available... Rather, if the data are favorable, we plan to proceed with application of an additional indication based on the results. IZERVAY has a target date of November nineteenth as PDUFA target in the US. In Europe, we currently expect a decision from the authorities in the second half of FY 2024.
The timeline may change depending on comments from the regulatory authorities, and we'll provide updates as appropriate. On page 19, I will explain the outlook for POC judgment under the focus area approach. In the lead programs in each primary focus, for programs such as AT 845 for genetic regulation, ASP 2138 for immuno-oncology, ASP 7317 for blindness and regeneration, and targeted protein degradation, ASP 3080, will advance to the POC review stage by the end of FY 2025. We expect that the success of these lead programs in obtaining a POC will enhance expectation for success of follow-on programs utilizing the same platform, and bring the concept of the focus area approach closer to reality, which is to generate promising new drugs continuously.
To accelerate the program creation and a POC decision, R&D has made a significant reform to its organization and operational model for development projects, with proactive delegation to teams to enable faster decision-making. In addition, we are reviewing the use of external resources and strengthening our internal capabilities to more effectively and efficiently promote the development in new modalities and in disease areas in which we have little experience. In addition to these measures, we will further strengthen resource allocation to priority projects and focus on POC decision. Page 20, I will explain the change in the definition of core basis. In addition to the other adjustments, amortization of intangible assets, gain on the divestiture of intangible assets, and a share of profit or loss of investments accounted for using equity method, have been newly excluded as new adjustment items from other core definition starting in FY 2024.
This is because the acquisition of Iveric Bio has resulted in a significant increase in amortization of intangible assets, which makes it difficult to adequately represent profitability under the old definition. We believe that the new definition of core basis will more appropriately show the company's profitability and ensure comparability with the global pharmaceutical companies. For reference, the lower part of the slide shows a change in core operating income, reflecting the new definition. Now, you can see that the acquisition of Iveric Bio has significantly increased the amount of amortization of intangible assets and the ratio to revenues compared to FY 2023. Page 21. Now, I will explain our full year forecast for FY 2024. The forecast for revenue is JPY 1.65 trillion, an increase of JPY 46.3 billion year-on-year.
The impact of the entry of generic mirabegron in the US has been included in the assumptions for the full year forecast of revenue. The decrease in sales of mirabegron is expected to be offset by sales growth of PADCEV, VEOZAH, and IZERVAY, which are expected to increase by JPY 120 billion year-on-year. GC&A expenses are expected to be JPY 757 billion. GC&A, excluding co-promotion expenses for XTANDI in the US, is expected to be JPY 568 billion, an increase of JPY 22.8 billion year-on-year. The main reason for this increase is the necessary investments in growth drivers, such as PADCEV, VYLOY, VEOZAH, and IZERVAY, which are expected to increase by about JPY 35 billion year-on-year.
On the other hand, we continue to reduce expenses for mature products, which is expected to decrease by about JPY 9 billion year on year. In addition, I expect to realize cost reductions of about JPY 10 billion as a result of global organizational restructure implemented in FY 2023, including a review of sales structure in Japan. R&D expenses are expected to be JPY 317 billion, an increase of JPY 22.8 billion year on year. We will continue to invest to strengthen primary focus on R&D functions in general. On the other hand, we will also review our portfolio to reduce costs. We will strictly prioritize the allocation of management resources and investment in growth areas, while thoroughly reviewing expenses that will now contribute to future growth and value enhancement.
As a result, core operating income is expected to be JPY 250 billion, a decrease of JPY 26.9 billion year-on-year, and a core operating margin is expected to be 15.2%, a decrease of 2.1 percentage points from the previous year. Although the impact of generic mirabegron in the U.S. will be factored in, we will prioritize expenses thoroughly and minimize the decrease in core operating margins. The lower part of the slide shows a forecast on a full basis. Operating income is projected to be JPY 48 billion year-on-year. We expect amortization of intangible assets of JPY 140 billion to be a major adjustment item that is excluded from the core basis. In addition, we have factored in other expenses of about JPY 60 billion, including the risk of impairment losses.
We forecast a dividend of 774 JPY per share for FY 2024, an increase of 4 JPY per share. We have revised our previous dividend increase range in light of slower than expected profit growth, but we remain confident about our future profit growth, and have increased our dividend forecast to 4 JPY per share. On page 22, I would like to explain the CSP 2021. In light of the progress made so far on the three performance targets outlined in the CSP, we believe that it'll be difficult to achieve the targets for FY 2025. On the other hand, the original theme of the CSP 2021 is to build a structure that can overcome the patent expiration of XTANDI, and we believe that it is extremely important to firmly establish such a structure during the remaining period.
In terms of revenue, the main growth drivers are PADCEV, IZERVAY, VEOZAH, and VYLOY. We expect total sales of strategic products to nearly double to JPY 300 billion in FY 2024. In FY 2025, we expect this figure to triple to JPY 500 billion. We expect profits to grow along with this sales growth, with a core OP margin expected to rise from 15.2% in the FY 2024 forecast to the low 20% range in FY 2025. We believe that the initiatives and milestones, as shown on the right side of this slide, will be particularly important for the future growth of our priority strategic products. We will continue to pursue a core OP margin of 30% as our goal by steadily advancing these initiatives.
If we succeed in acquiring a POC for Primary Focus program by the end of FY 25, we expect to build a pipeline that will enable sustainable growth. Thank you very much. That's all from me.
Thank you very much. That's all, as an explanation from our company. We now would like to entertain questions from the audience. If you have a question, 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. The MC will name you one by one. If your name is called, please unmute yourself on your screen. Please mention your name and your affiliation before asking questions. Thank you for waiting. First, Mr. Yamaguchi from Citigroup Securities, please.
Can you hear me? Yamaguchi from Citigroup.
Yes, we can hear you. Thank you.
I have a few questions. First, regarding CSP, you reviewed your assumptions, as you explained in your presentation, FY 2025, the same view remained the same, but the numbers are a bit challenging. The numbers... Are you reviewing the assumptions for the numbers? The final numbers will be revisited once again. Is there any such possibility?
Thank you for your question. What do you mean by revisit? I wonder how I should interpret the current numbers in your assumptions, which you can, you think you can achieve. CSP 2021, we set performance goals in CSP 2021. The performance goals themselves, we have no intention to change. This was developed three years ago, so instead of changing through rolling, we'd like to keep the goals as is. And for the goals, what is going to be a landing? That's what I presented today. In that sense, in FY 2024, we have an annual plan already. In FY 2025, basically, based on the plan for FY 2024, we added scenario planning to show these numbers for you.
When we have an annual planning for FY 2025, we cannot rule out the possibility that the assumptions have changed, but these are the numbers we have confidence about, which we are presenting today. I hope I answered your questions.
Thank you. The second question is about IZERVAY sales forecast. You explained the sales forecast. If I understand what you explained, J-code was approved effective the first of April, which increased demand. And also, label update, PDUFA date is November nineteenth, when the volume will increase further. In terms of the impact, it can be big product. What would be the biggest... What would be the most impactful element?
Thank you for your question. Where should I start? First of all, permanent J-code has a big impact, I think.
Reimbursement procedures will be easier for physicians and HCPs. If, if they are not accustomed to such a procedure, they. Some of them are maybe waiting until the procedure is simplified. We can expand the customer base, so in that sense, it's very important. On the other hand, for each patient, how much the drug can be utilized? In that sense, there's going to be a normal restriction about the usage period for 12 months. This is a drug you have to use on a chronic basis, so I think that's also important. And regarding the numbers in FY 2024, it's not reflected so much, but not just in the United States, but also in other countries. We'd like to launch IZERVAY in those markets as well. So we'd like to expand the number of countries as well.
So, these are three elements that are very important. Instead of saying, which is the most important, we'd like to implement those three at the same time. And about mirabegron, it's a sensitive question. It's difficult for me to ask you, but still, it's included in the sales forecast. According to a press release last week, the district court recommends denying your motion. According to generic manufacturers, I heard that the injunction in the appeals court worked. So on this point, as far as you can share, could you give us your comments?
As you... Yes, you're right as a fact, but the injunction by the appeals court, it's called temporary. How long it's going to be effective, it's not so clear.
So it's an injunction. Compared to what we call, injunction in general, the duration is very limited.
Understood. Thank you very much.
Morgan, Morgan Stanley MUFG Securities, Mr. Muraoka, please.
Good afternoon, Muraoka from Morgan Stanley speaking. Thank you very much for giving me the opportunity. Also, show us slide 22. That is, core OP margin based upon the new definition is going to be the low 20%. That is where that you are going to return to in the next fiscal year. Would you please explain about the journey toward that a bit more into details? With these five products to make a growth, then OP margin is going to be improved automatically. I think that's a simple story, but from the current status, I believe, there's a certain distance. So would you please explain a bit more about this?
Thank you for the question. Muraoka-san, what you said is exactly what we are thinking.
I see. In that sense, PADCEV and IZERVAY, those are likely to grow great, grow greatly, so you depend on that? Well, the, those two product sales expansion, well, that is likely to be the sales expansion that is likely to hit the bottom line. I don't know if that is the right way to say. But when. Okay, then when it comes to VEOZAH, after this, revisiting in FY 2025, it is coming up with the profit or still waiting for the profit from VEOZAH in FY 2025?
It is not appropriate to disclose the detailed number to you here today, but at least, it has to go to the nearly break-even point personally speaking, but of course, our sales alone or the revenue itself, we cannot control, but we can control the cost. Therefore, even in the middle of the fiscal year, we always refer, we'd like to refer to the KPIs so that we can flexibly adjust the our sales mix. That is going to be the foundation that we have currently. So around FY 2025, we I hope that this achieves the status of coming up with a profit.
Thank you. Now, about the dividend. Within this 1-2 weeks, among the investors, we discussed and also we received a lot of questions about the dividend, and you came up with a number of 74 JPY. And in some page, said certain picture, but, depending on that, in the next fiscal year, the profit will grow. So at this time, the every 10 JPY basis, therefore, from next fiscal year, another 10 JPY is likely to be added on, according to the picture that you are drawing. So the JPY 500 billion for the major proof duct and the co-pay margin and the low 20%, then the conventional level of the increase is something you think you could achieve. Is that okay to consider in that way?
Thank you very much for your question. Of course, we would like to continue the increase of the dividend, and also we would like to increase the range as well. But on the other hand, as you know, extending patent expiration is going to start from FY 2027 and afterwards. Therefore, this year 10 JPY, next year 20, next year 10 JPY, next year reduction. That's something we would like to avoid. We look at the profit situation from mid to long terms, and based upon that, we would like to decide the amount of the dividend every year. So FY 2025, 2026, what would happen is something I would rather refrain myself from commenting. But as I've mentioned, capital allocation perspective, the stable increase of the dividend is our basic direction.
So it's not a fraction increase or decrease depending on the level of the profit. So that we can avoid such situation, we would like to always have to do that in a planned manner.
If there's a stable profitability, then according to this current situation of your company, JPY 4 is appropriate level.
Yes, that's right.
Thank you. Now, about VEOZAH.
Come to say.
Affordability, it was mentioned, in your slide. I'd like to confirm. In, year two, there would be competitors lowering the price to secure the coverage. Is there any possibility to take such a strategy? Sorry, I may not be catching up. Is such a scenario possible? Is it highly likely or not likely? Could you explain?
Yes. Regarding the affordability, what to do with this price, what about the gross to net? That's one thing, but what we'd like to say here is that, what is going to be the co-payment of the patients? We are talking about the absolute amount. Original assumptions were made. Initially, we are assuming a small amount of co-payment as an assumption for the patients who use this drug, but that's not really the case in reality. Prescription was given, they go to a pharmacy, it's available, but co-pay is high, so patients may say: "No, thank you." There are such patients. So how we can decrease the out-of-pocket payment by the patients? We have to consider it. Lowering the list price itself or increasing the gross to net, there can be a variety of ways, but for us, we shouldn't hurry too much.
Increasing gross to net to rebate, then in the long term, the value of the product would be undermined. We don't want to do this, so we'd like to think of a smarter way, in taking a variety of action. That's all.
Understood. Thank you very much. That's all from me.
Thank you very much. Next, Goldman Sachs Securities, Mr. Ueda, please.
Ueda from Goldman Sachs Securities. First of all, I'd like to ask you a question about the process to develop your plan. When you announce the results before you are going to review the process to develop your plan, specifically, how did you change? You said you want to be ambitious, but you also paid attention to something achievable. What has been changed compared to last fiscal year? What is the difference in the probability of achieving your plan?
Thank you for your question. I'd like to explain, and where necessary, Kitamura sitting next to me can add comments as well. First of all, FY 2024 annual plan or budget is being developed.
Our biggest challenge is that we need to develop a plan which can be delivered for sure. Of course, it must be ambitious; otherwise, the organization would be less motivated. So we will use ambitious numbers, but still it could not be achieved. That should not happen. We would perform a scenario analysis in advance. We refer to bottom up, but in the end, as corporate as a whole, we will take risks here and here, and in other areas, we would not take risk. We incorporate such a process in the annual plan for FY 2024. And also, it's easy to talk about prioritization, but doing this for sure is something tough because we see people and things, but there are three priorities internally, and accordingly, at various places, we determine the priorities.
Some may have to endure, and we may have to give up in some areas, or we may have to postpone. But we want to allocate human resources and money to what requires such resource allocations. That's the current status. As I said on page 15, near background generics entry, financially speaking, we need to factor in such a potential risk. We don't have any sign, but intangible assets are always on the balance sheet. For what reasons project terminate, there would be impairment loss. So we have to pay attention to those areas, and that's how we are planning this time. Kitamura-san, anything to add?
Thank you. As Okamura said, yes, I agree, but I'd like to add two points. Regarding scenario, in principle, it's quite severe. Will it be a worst-case scenario?
To overcome that, what should be done? There can be good scenarios and bad scenarios as well. We, based on very conservative scenarios, develop a cost planning. Regarding priorities, which was mentioned earlier, we had very tough prioritization. On the other hand, not just creating numbers in the plan, but we have to think about how to do the operations. It's about the actual processes. Specifically, when do we need to make what commitments? By then, what do we know and how to do this? Such a process was discussed in detail by the top management, so we'd like to deliver these numbers for sure.
Thank-- That's all from me.
Thank you very much. The second, this may be related to the operation, just like you mentioned. The forecast for SG&A, this fiscal year, including JPY 35 billion for the strategic products, relatively, the amount is larger. Maybe you invest in advance for those products. But next fiscal year and afterwards, to think about outlook, what would be this distribution, the percentage? And this time, once again, is it okay that the current investment is advance treatment?
Okay, for this as well, I answer, and Kitamura-san will follow. As I've mentioned at the very end slide, core OP, based upon the new definition, that is at 30%. For the pharmaceutical companies like our position or the direction, is the appropriate amount to aim at. From there, we are going to back calculate for the cost of goods and so on so. Then automatically, we come up with the SG&A level to achieve the 30%. So with this as a goal, overall, within this range, so that we can operate our business, we would like to establish the structure of the system. So we would like to have a more muscular structure with this target.
Thank you very much. What is quite important, as you see on this slide, in FY 2025, for these strategic products, we come up with the sales of more than JPY 500 billion. This is critical. So in order to realize this necessary investment is definitely executed. And at the same time, just as Okamura mentioned, there will be the increase, so where should be the decrease?
That will be the other SG&A and other expenses, for example, including the digitalization. We can reduce certain costs, so we would like to do that. At the same time, FY 2025, there are more than 20 months till then, so we are going to do the short-term investment for this fiscal year.
Toward the 2025, that is going to be the midterm improvement, so the time axis will be different, but we are doing so in a simultaneous manner.
Understood. Thank you very much. That's all from me.
Thank you. Next, UBS Securities, Ms. Haruta, please.
Haruta from UBS. Thank you very much. First question, that's about extending U.S. forecast. That's the question from me. In the guidance this time, FY 2025, January to March, there will be a negative impact. But the remaining calendar year of 2025, the impact will continue. But for 2026, well, in 2025, the drug price is reduced, and from there, to what extent demand will improve?
Based upon that, you come up with a focus for 2026, 2027 in IRA.
If you be included within the list, then further price decrease by about 30%. So for the coming three years, is it okay to expect the coming three years in that way? Would you please explain that? Well, the journey or the direct route to think about what's coming, I think what you mentioned is quite right. But is there anything else needed to be added, Claus? If you have any, would you please make a comment?
The only thing I would add is that, we are very encouraged by the volume growth that we are seeing. I mean, we've been on the market for more than 10 years, and we're growing 4% in paid demand. So. That has even strengthened in the last quarter, with the publication and the approval of the EMBARK indication. So, there is demand in the market, and yes, we have an environment which over time will be unfavorable on the price front, but the volume prospects, I think, continue to be very good in terms of long-term growth.
Understood. Thank you very much. The second point, that's about VEOZAH. About the doctors' or HCPs', intention for the treatment. That's what I'd like to know. There's a market itself because of the hormonal therapy, but now VMS recognition as a disease to be treated amongst HCP is lowered, and there is no activation by HCPs for the treatment. What is the current status with that regards? That's what I want to learn. Rather than the enthusiasm for the treatment itself, the coverage of the insurance, that itself is a more stronger factor for the bottleneck. That's the question.
I'd like to comment a bit, and then I'd like to ask Claus to make additional comments after. Yes, you are partly right. A VMS in the education process or in educating the clinical information, they may not have studied much, but open the practice. Oh, we noticed, and that's the situation. So, sales force must ensure a disease education, even to physicians as well, HCPs, and also in a peer-to-peer fashion using the network. This should also be done as well. On the other hand, regarding the coverage, if you perform market research, they have intention to prescribe. They are willing to prescribe, but what kind of patient should come and how they should explain to prescribe, that's a missing link. So sales force and medical reps have to fill this gap.
The coverage gap, coverage issue, what we are concerned about is that doctors are willing to prescribe, and there are patients coming to them, and a prescription could be written under those circumstances. But because there's going to be no reimbursement, some doctors would not prescribe. They wrote a prescription, but the patients bring it to pharmacy, but it's too expensive, so they may say, "No, thank you." Because of no insurance coverage, they were told to take the advanced procedure, so it's too cumbersome. There are doctors who'd like to prescribe, and there are patients, but still, it's not linked to the actual prescription. I think that's the area where we'd like to see a faster progress. Doctors themselves must be...
We need education to them because they didn't learn in medical school so much about this. As our customers, when we want a doctor to prescribe a drug, still they don't write a prescription, so we have two dilemmas. Claus?
Yes, what Naoki just described is exactly right. So the one factor is the perception from HCPs that we know from our market research that they think the coverage is not, you know, broad enough for them to prescribe. And it takes time to overcome perceptions in any market, right? Now, we are making good progress on the payer front. You know, we always said we would reach 50% coverage by the end of FY 2023. We've delivered on that. We're now aiming for more than 80% coverage by the end of FY 2024. I think we're going to be very nicely tracking on that. And over time, we will be able to convince HCPs that coverage is now broad enough for them to prescribe freely.
And that is the sales force job, just as Naoki just said. And at the same time, we're building a new class, right? So we have to educate doctors of the advantages versus the SSRIs or HRT treatments that they're used to prescribe in the past. So those are the two factors, exactly like Naoki said.
Understood. Thank you very much. It's now clearer for me. Thank you very much.
Thank you very much. Next, Mr. Hashiguchi from Daiwa Securities, please.
Hashiguchi speaking. Thank you very much. On page 22, you talked about XTANDI LOE, and you are going to establish a structure to overcome XTANDI LOE. What's your definition? What kind of a situation would mean a sufficient structure to overcome XTANDI LOE? When you announce CSP 2021, I am seeing the slides once again. According to the forecast at the ten, sales and core operating profits in 2023, I think it's going to be a higher level. But you are changing the definition of the core operating profit. Products which you think are going to grow, XTANDI, according to the new definition, the profit structure is going to be different.
There may be operating profits for some of the products and not for other products. So I'd like you to elaborate on what you are talking about in this regard.
Excuse me, I am not quite sure what I should answer. Would you please repeat your question once again?
Well, let me ask you in a different way. When the CSP was announced in FY 2021, the more than JPY 500 billion of the sales increase of FY 2025 for the strategic products, then you can overcome the loss of the exclusivity of the XTANDI, and you can come up with the long-term growth. But just like Okamura mentioned today for focus project, currently, there's a bit of the delay in such situation.
With what you can declare that you're now prepared to overcome XTANDI LOE as of 25, FY 2025? As you see it on the slide 22, strategic products, and also with those sales increase, XTANDI issue can be overcome, or the new definition-wise, the profit is exceeding the current level. So when do you declare that you are able to overcome the issue of loss of exclusivity of XTANDI?
That's the question. Understood. So, well, first of all, the sustainable or continuous growth that we think, well, of course, these are the drugs, so the LOE or the patent issue they are, they always come. So there will be the year of discontinuity.
I believe I discussed this a lot with Hashiguchi-san in the past, but that this, there is almost no case that the profit comes out during that vacuum period. So what we are aiming at is the current XTANDI sales is about JPY 700 billion, and then there, we come up with a profit. And that profit, if that is raised from other products, in other word, XTANDI is gone, but we have the other products as alternatives or replacement. Then, as of FY 2021, because at the time, well, at the time we did not have IZERVAY, but that there was six compounds, and 8132 was added.
But anyhow, with those key products or strategic products, profitability structures, although different from the XTANDI, so it's not really about the revenue or the sales, rather, operating profit that is gained from the XTANDI can be replaced or offset. That is the status we would like to achieve. And at the same time, based upon that, from the primary focus, if we have some other products potential, then with the replacement of the XTANDI, we have another potential product from our primary focus that will lead to the further growth. That's what we are thinking. However, the strategic products status is different from the time of FY 2021. And also, primary focus potential products are not near, but rather a bit far future.
If we can see, that is we highly expect ended up with a failure in the clinical trial. So in order to offset such situation, we came up with the IZERVAY, with acquiring Iveric Bio. Did you get it? I just wonder if that is a logical explanation. I understand it quite well. But with the IZERVAY now available, so according to your explanation, operating profit is it can be replaced. But you are thinking about the replacement of operating profit based upon this current new definition, right?
Right. Rather than the accounting-wise profit, I always think the situation based upon cash flow. So for me, IZERVAY, from the cash flow perspective... regardless the definition of core operating profit, it's the same thing.
But from the investor's perspective, currently based upon the current core P definition, you don't understand actually what is happening. We hear that a lot. That's why this time we decided to change the definition of core P.
Understood quite well. Thank you very much. Another point for me, that's about zolbetuximab or VYLOY in Japan, maybe. In Japan, initially, you focus on the penetration of the testing. That's why you come up with that number for the sales of this year. But claudin 18.2 recognition among the HCPs here in Japan is expected to higher compared to Western countries. And if you come up with that forecast here in Japan, in Western countries, after getting the approval, it seems that the sales growth will be relatively slower.
Is it okay to say in that way?
Thank you for your question. In the HCP community, from the Japanese physicians' perspective, how to think about claudin 18.2? I'd like to have a comment from Taniguchi. And what about the plan by the commercial team, together with the medical affairs in collaboration, how to roll out VYLOY in Japan? That is going to be explained by Claus. First, Taniguchi, please. Okay. I'd like to talk about claudin 18.2 awareness. From the medical affairs perspective, the awareness is getting higher. Gastric cancer prevalence is high in Japan. There are many cases in our country, and Japanese doctors are eager to learn and study. So a new marker with high sensitivity, they are dealing with this. At a GIE physicians' meeting, we have a booth, and many doctors visit our booth at an exhibition.
From that perspective, still, it's very important for them to test. In gastric cancer, HER2 and PD-1 testing were generally done, and claudin 18.2 testing, hopefully would be done by the doctors to begin with. So we'd like to penetrate the testing. That's very important for the success of VYLOY, as, we wrote here. Claus, please.
So we are very encouraged by the fact that the guidelines have already included in Japan VYLOY as claudin 18.2 testing together with the HER testing. So that gives us a very good basis to communicate to doctors that both tests should be done at the same time when a patient presents. So I do think that in Japan we actually have a very good environment in terms of getting doctors to understand, be aware, and then also order the claudin 18.2 tests.
Thank you very much. That's all from me. Thank you.
Thank you very much. Next, JP Morgan Securities, Mr. Wakao, please.
Wakao from JP Morgan Securities. Thank you for your time. First, as Hashiguchi-san asked the question, I'd like to know more about the same topic, CSP 2021, XTANDI LOE. You talked about a structure to overcome XTANDI LOE. If you have such a structure, if you cannot establish such a structure, what measure are you going to take? If by 2025, strategic product sales of JPY 500 billion, that's next fiscal year, I think the possibility or the probability is quite high, but based on the definition, there can be some challenges. So strategic products may not grow as expected, then either way, something like an acquisition or like either way may happen. It may be difficult to acquire those products, but there may be an acquisition of late-stage compounds, of which you may consider.
Regarding Focus Area, you need to judge POC. If you cannot achieve POC, another Focus Area would be tried one after another. Should I understand that way?
Regarding the focus area, do you have a plan or way to make further improvements?
Thank you for your question. Regarding your first question, for us, in principle, innovations to create a company, if possible, products close to completion in the late-stage phase or companies, we don't want to acquire.
... them. But as you said, things may not proceed as we expect. We say we want to generate innovation, so we just shouldn't wait. We decided to acquire Iveric this time, as you pointed out. If you look at our balance sheet next year, it's impossible to acquire a company worth JPY 500 billion. Average value acquisition was done for the coming few years. Acquiring a big product or a company could be difficult, so R&D people sitting right to me must work very hard. Sitting on the left of me is Claus. So we delivered strategic products to the market. So Claus-san, you have to work hard. Of course, I feel that way. Regarding the focus area, focus area is our way of thinking about R&D.
You wanted to talk about Primary Focus, right? Primary Focus. Within one Primary Focus, biology, modality, and disease exist by making small changes one by one. This is what we call a pivot. By moving on the triangles little by little, one modality is now dissolved. We may terminate a certain Primary Focus and creating different Primary Focus somewhere else. There is flexibility here, and that's the good thing about the Focus Area Approach.
Then more specifically, by 2025, I expected to gain the POC. But if that would not happen, what should we do? That's also what I'm interested in, so I would like to hear it. So let's start with the clinical phase. So first of all, Taniguchi, then after that, Shitaka, higher than that level. What you're thinking is something we'd like to hear. Thank you. Let me speak first. It's about the clinical development. First, the ADA 45, this is for Pompe, and ASP 2138, this is oncology, and the 7317, this is the AMD geographic atrophy, and the 3082, this is a KRAS degrader. So these four, we would like to get the POC decision by the end of 2024-5.
So at least these four. Of course, other than, those, we have other, programs that we may be able to decide the POC, in the, this, period of the time. But new products or early developed products or products in an earlier development phase, those are also something we would like to focus on. Shitaka is going to talk about after me, but from the, research, we, get, something and we want, have it into the clinical phase, so that we can increase the probability of gaining POC. That's what we are trying to do.
On top of that, as has been shown in the slide 22, for example, PADCEV LCM or line extension, that is also something we are thinking about and already in head and neck cancer, the new study is taking place. Other than that, for VYLOY, there is the pancreatic cancer. But for the gastric cancer, that... Rather, other than pancreatic cancer, we would like to expand the indication so that we can find the other value. So those are considered for LCM. So early phase, late phase LCM go together, and with that, we can come up with a higher level of pipeline value. That's what we think, and that's why we are doing our best for that. Now, Shitaka will make explanation.
Just like Okamura mentioned, we would like to transform innovation for the value of the patients, and that's the driver for our growth. Now, Primary Focus will be turned over, as has been mentioned this time, and we will find another opportunity of the science innovation. That's one way that we can do. And also within the Primary Focus, different and several platforms are verified one after another based upon the hypothesis that we have. For example, immuno-oncology. Unfortunately, Potenza and Evic couldn't come up with the evidence to verify our hypothesis, but some are already in the dose escalation study.
But we have 2130 and so, and within immuno-oncology, the different factors are utilized, and we have something else that we can expect for the next phase. And also, the targeted protein degrader, the situation is the same. The KRAS is the first, so that we can launch the product. So the mutation, mutated types-
... we are now in the clinical phases, and the greater, not depending on the mutation, KRAS G12D, that is also identified, for the clinical phase. Non-KRAS, oncology and immuno-oncology, are where that we would like to make use of. We change PF, or within a PF, or primary focus, we can, verify the different platforms. We can do other ways, but which of our cases, we would like to transform the innovation to the value, so that we can grow further. That's, what we are aiming at.
Understood. Thank you very much. That's all from me.
Thank you. Next, Sanford C. Bernstein, Sogi-san. Mr. Sogi, please. Ms. Sogi, please.
Thank you. I have a question about PADCEV and VEOZAH. First, about PADCEV, in 2024 forecast, 145 JPY against the dollar.
Based on that assumption, FY2024 sales forecast may be very aggressive according to my impression. First line, market share. What's your assumption about market share to come up with these numbers?
Thank you for your question. Straight to Claus.
So I expected you to be surprised by our PADCEV forecast, because we are extremely confident on that. You will remember that in Q2, we took up the PADCEV forecast significantly, and we have delivered on that. We actually a little bit over-delivered on that, and we think that trend will continue. Yeah. Our market research shows a very typical market share in terms of new patients. About half of the new patients would go on PADCEV pembro first-line combination. We now have three guidelines, three guidelines in the world recommending PADCEV pembro as the standard of care. That's the ESMO guideline, that's the European Association of Urology guideline, and the American NCCN guideline, we're also category one. I think we are upending this market.
We are changing this market completely, and it is very clear from our feedback from HCPs, from medical societies, that they see PADCEV and pembro as the first option for patients with bladder cancer, and that is giving us that confidence. I think our track record since Q2 proves us right so far. So I would ask you to be confident also in the FY 2024 forecast.
Great. So does that mean that you're assuming, you know, the PADCEV achieve 50% market share during the first year of the, you know, the new indication in the first line?
In the U.S., for instance, where we have first line on the market, we already have more than 50% market share.
I see. Great. Thank you very much. That's very impressive. The second question is regarding VEOZAH. Probably this is also a question to Claus. So, you know, thank you for, you know, explaining some of the challenges coming from the payer coverage. I also believe that, you know, another key, you know, challenge is probably, you know, the lower than expected demand from the patients and the... So I believe that, you know, the quite significant DTC to mobilize those patients is quite important for this product. First of all, I'd just like to understand, is that in the right understanding?
And also, the second question is, in order to do that, what is, you know, this year's budget for the promotion fee for VEOZAH, and also if there's any change you're planning to make for the promotion approach based on, you know, what you have learned so far?
Okay, that's at least half a dozen questions in one, but I'll try to take them. You are absolutely right that our initial assumption, we expected an exponential response curve from the DTC, and that is—that has not happened. And the more we study this market, the more we believe that we are progressing it in a linear fashion. We've also modeled that versus some analogues. It just seems to be a market that progresses linearly, and that is also proven true in the fourth quarter. We've increased demand by about 60% in the fourth quarter, and we see that demand creation being slower than initially expected, but being steady going into the future, yeah. So yes, it does take DTC spend to activate that.
Yes, that will have to continue for some time. I mean, please remember, we're still within the first 12 month of launch, right? I mean, we haven't even completed the first year of launch. So yes, we will continue on the DTC spending to activate consumers. And we'll be updating you in the next call when we have some fresh market research on how we have affected awareness of HCPs, but also of consumers of the brand, which if you remember, in December, was still only at 25%, on the consumer part. So yes, DTC will be necessary to continue to activate patients, but no, it's not exponential, it's more a linear progression.
My question is, how much you are planning to spend for VEOZAH promotion this year? And also, I mean, if there is any new learning that, you know, you have, you know, gathered so far that will be applied to how to promote this product.
Yeah, I'm not going to give you the number you're asking for in terms of the promotional spend. I can tell you that we have. As I think Naoki said in his presentation, we have monthly KPIs, where we look whether we hit the KPIs, and then we modulate the spending accordingly, yeah? To your second question, yes, we are learning very quickly, and we are adapting the spending mix, you know? So as you're aware, DTC is not just TV spend, right? It's TV spend, it's digital spend, it's, you know, Google choices. There are various categories of spend in that spending mix, and we are learning and adapting that spending mix as we get real-time data, and that is going on right now.
I do think our spending will be more effective in the future because of that learning curve that we're progressing on.
Thank you very much.
Thank you very much. Thank you very much. We are already after the expected finishing time, but one more question. Mr. Tsuzuki from Mizuho Securities, please.
Thank you for accepting my question. ASCO, I believe the title is already disclosed. EV-202, the new data is going to be announced there. Is this understanding right, Taniguchi-san, please?
EV-202 study, last year for head and neck cancer, the data was disclosed and announced, and abstract is now disclosed today. Other cancer types, for example, breast cancer, lung cancer, esophageal cancer, such a data of 202 study is planned to be announced.
Understood. Thank you very much.
Thank you very much. Now time is up. With this, I would like to close today's earnings call. Thank you very much for your participation.