© 2024 Alpha Spread Limited. All Rights Reserved.
www.alphaspread.com is not operated by a broker, a dealer, or a registered investment adviser. Under no circumstances does any information posted on www.alphaspread.com represent a recommendation to buy or sell a security. The information on this site, and in its related newsletters, is not intended to be, nor does it constitute, investment advice or recommendations. The information on this site is in no way guaranteed for completeness, accuracy or in any other way. In no event shall Alpha Spread Limited be liable to any member, guest or third party for any damages of any kind arising out of the use of any content or other material published or available on www.alphaspread.com, or relating to the use of, or inability to use, www.alphaspread.com or any content, including, without limitation, any investment losses, lost profits, lost opportunity, special, incidental, indirect, consequential or punitive damages. Past performance is a poor indicator of future performance.
You don't have any saved screeners yet
Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
Hello, everyone, Yasukawa speaking. Thank you very much for joining our teleconference despite your very busy schedule today.
First of all, I'd like to talk about our first half results and our initiative for sustainable growth. Page 2 is a usual cautionary statement. I'm not going to read this. Page 3 is the agenda for today.
I'm going to start explaining from Page 4.
Page 4 shows the first half consolidated financial results. Revenue was JPY 615.5 billion, down 5.4% year-on-year. COGS ratio mainly due to changes in product mix declined by 1.9 percentage point year-on-year. In-licensing products in Japan with a relatively higher growth ratio had a decrease in sales. SG&A costs increased by 7.1% year-on-year. XTANDI's co-promotion fees increased.
Last year, we had the reversal of loss allowance and with the one-off cost decrease in the second quarter in the previous year, but not this year. That's one factor for the cost increase in the second quarter this year. Excluding these 2 factors, the amount of SG&A costs declined year-on-year. And the expenditure increased by JPY 6.7 billion or 6.4% year-on-year.
Roxadustat and darolutamide development costs already peaked, but fezolinetant development cost increased. And also, Audentes R&D expenditure was added. These were the factors for the increase. As a result, core operating profit was JPY 130.3 billion, down 22.4% year-on-year.
The bottom half of the slide shows full basis results. Other expense of JPY 47.7 billion was booked. Main factors include the following: we acquired Potenza in 2018, and we acquired anti-TIGIT antibody ASP8374, which we decided to discontinue development, and we booked impairment loss of intangible assets. As a result, operating profit was JPY 86.9 billion, down 46.4% year-on-year. Profit for the quarter was JPY 72.8 billion, down 43.3% year-on-year.
Next, Page 5. This slide explains the details of the first half revenues. Main products in oncology continued a strong growth trend. XTANDI, with the approval of MR CSPC Indication in the United States at the end of last year is continuing to perform well in the international markets, in Russia and Brazil. M0 CRPC was approved as an additional indication. And since sales are increasing, we also launched in China in March this year. New prescriptions are increasing steadily. XOSPATA is now marketed 16 countries in the world by now. In addition to Japan and the United States, a launch in EU is also beginning to contribute to sales. In July, U.K. NICE recommended the use of XOSPATA as a treatment of relapsed or refractory AML.
Enfortumab vedotin, or PADCEV, with positive clinical study data readout, oncology specialists having high expectations. New prescriptions are increasing steadily. I will explain the pursuit of opportunities to maximize the product values and our future expectation for sales. Revenue for main products and new products shown here in total, increased by JPY 50.1 billion year-on-year, but consolidated sales declined by JPY 35 billion year-on-year. Main reasons are shown at the bottom of the slide. Sales of products with LOEs such as Vesicare and Celecox substantially decreased. Sales declined for products with termination of sales and distribution in Japan such as Symbicort and Micardis, although such sales were booked until last year. In addition, regarding Lexiscan in the United States and antimicrobial antibacterial agent, Geninax, demand decreased as a result of a reduction of in-person hospital clinic visit by patients due to COVID-19.
Page 6, please. Our progress against the full year forecast. The core basis of first half results are in line with our full year forecast revised in August. As is shown at the upper part of the slide, the progress against the full year forecast is 49% for revenue and 51.9% for core operating profit. Main products supporting the growth, such as XTANDI, XOSPATA and PADCEV are increasing in sales. Business fundamentals are good. The impact of COVID-19 on product sales is getting milder in comparison to the first quarter as expected. As you can see in the middle of the slide, Lexiscan in the United States and Prograf in the EU were affected a lot by COVID-19, but the sales are returning to pre-COVID-19 levels. As for full basis shown at the bottom of the slide, we booked JPY 30.5 billion impairment loss on intangible assets related to ASP8374. At the beginning of the fiscal year, we cannot predict this development discontinuation during the year. So for such a discontinuation, we announced our revision to the forecast.
Page 7. This is an overview of the FY 2020 full year revised forecast. The top part shows core basis results and forecast. Core basis results are in line with our full year forecast, as explained earlier. Core base full year forecast for FY 2020 were revised in August and no changes are going to be made to that. The bottom half of the page shows full basis forecast. We have cited impairment loss. So FY '20 full year operating profit forecast is going to be JPY 210.5 billion, down JPY 36 billion, and full year profit is revised to JPY 169.5 billion, down JPY 28 billion.
From Page 9, I'd like to talk about initiatives for sustainable growth. Page 9 shows the status update for key late-stage projects. 3 months ago, we made the announcement and the progress since then is underlined. In the top left is enzalutamide. M0 CRPC was studied in Phase III PROSPER study. And for label update to include the OS data, we are filing in the United States and EU, and this was approved in the United States this year.
In the middle, the second from the top, gilteritinib. The top one in the middle, it's not shown on the slide, without any underlying. I'd like to give you an update on the latest information in China we are filing. For priority review, gilteritinib clinically urgently needed overseas new drug list was published yesterday, and gilteritinib is now included in that list. This is still open to public comments, but if officially decided, review is expected to accelerate.
The second from the top in the middle, zolbetuximab. Due to COVID-19, enrollment was suspended for some time, but enrollment resumed for the studies at 95% of the sites. In the middle, at the bottom, fezolinetant. At one point in time, enrollment for Phase III studies was suspended, but it's resumed, and we are making steady progress.
Pivotal studies, placebo-controlled studies, there are 2 studies, one of the first, SKYLIGHT 1. Last subject, last visit is going to complete soon for the 12-week double-blind period. SKYLIGHT 2, all patients observation for 12 weeks are complete. We are cleaning up the database right now. Long-term study, SKYLIGHT 4, screening was continuing for a long time. But now only with the patients under screening, we can achieve the sample size we are targeting. So screening is going to be completed soon. On the right, enfortumab vedotin. On the right, I'd like to explain the details later.
Page 10. Stage 4 metastatic urothelial cancer program as a whole is shown here. The progress since August is underlined. I'd like to explain the details on the next page. Page 11. First, global clinical studies, platinum and PD-1, PD-L1 inhibitor pretreated patients. First, in the previous slide, the very right-hand side in patients without any treatment options. In this patient group, in the United States, accelerated approval was already granted for EV. In this patient population, in the interim analysis of Phase III confirmatory study, EV-301 compared to chemotherapy arm in the EV arm, we met the primary endpoint of OS and secondary endpoint of PFS with a significant benefit. Hazard ratio was 0.70 and 0.61, respectively. Based on these results, we are going to have U.S. sBLA submission to convert from accelerated approval to regular approval. We are also planning global registrations such as EU and Japan as well.
PD-1, PD-L1 inhibitor pretreated, platinum-naive and cisplatin in eligible patients were the group, the second from the right, on the previous slide. In this patient population, our Phase II study EV-201 cohort 2 results were obtained an ORR of 52%, and positive results were obtained. Based on this, our U.S. sBLA submission is planned to expand the indication in the United States. We also started clinical studies and development in China. Pretreated patients to be treated with EV monotherapy, EV-301, EV-201, study data is going to be used in the China registration. There is a need for bridging with Chinese data. With the Chinese regulatory authorities regarding the study, we started discussions, but IND was filed because we reached agreement. We are going to start the study in the future.
Next, Page 12. Stage 2 or 3 muscle-invasive bladder cancer treatment. And this -- let me explain the treatment status. For further expansion of the indication with EV, we started development in MIBC for muscle-invasive bladder cancer in earlier stage of the disease. The bottom half of the slide shows the current status of the MIBC treatment. Standard of care is radical cystectomy. In cisplatin-eligible patients, new adjuvant chemo is also being used. On the other hand, prognosis is known to be poor despite surgery. Chemotherapies are limited to cisplatin-based 2 regimens, so there's no available systemic therapy for cisplatin-ineligible patients. In MIBC with high unmet medical needs, we'd like to expand the potential of EV plus pembrolizumab combination.
Next slide, we show the overview of the clinical studies. Slide 13. The rationale for applying the EV in pembrolizumab combination to MIBC or the rationale to start that kind of a study is that the clinical trial shows promising data of just over 70% ORR in the EV-103 trial, evaluating first-line treatment for metastatic urothelial cancer. And also nonclinical studies have suggested the combination may have potential to enhance antitumor activity.
For MIBC patients, the Phase III pivotal trials are going to be conducted. There will be 2 of them. The first one is the KEYNOTE-905, a study in cisplatin-ineligible patients scheduled for cystectomy, comparing a perioperative administration of EV with pembrolizumab to the cystectomy alone arm. There are 2 primary endpoints, EFS and PCR. The second is a study to the cisplatin-eligible, which is also currently under preparation in a collaboration with Seagen and Merck.
Page 14, enfortumab vedotin or PADCEV update of potential sales size. As explained earlier, we have decided to start a pivotal study of MIBC, which is Stage II and III of urothelial cancer. Along with this, the peak potential sales of PADCEV was revised to JPY 300 billion to JPY 400 billion. The causes of these factors of this revision? Well, in the past, target product profile, that is before the result of clinical trial or from the preclinical trials, the package in the description is predicted and also the efficacy is assumed. That is the beginning, but now the result is available. So based upon the actual data, we've revisited the forecast. And on top of that, the sales of the adopt of the patients have expected in the weakened sales from them and also the sales expected in China is added for revision of the number this time.
Page 15, that is about the progress in the focus area approach. First of all, mitochondria area, that is ASP0367. As per release last week, PMM, primary mitochondrial myopathies, as a treatment for that, FDA has granted a Fast Track designation for the development of ASP0367. PMM is a mitochondrial disease, in which genetic mutations primarily impair the function of mitochondria, resulting in a reduced muscle function and so on. In addition, serious and life-threatening health conditions such as myopathy, heart failure and respiratory failure or pneumonia might be induced due to dysfunction of the respiratory -- cardiac and respiratory muscle, respectively. The prevalence of this disease is estimated at 1 in 8,000 for adults with a clinical manifestation. Currently, no approval treatment is available, thus unmet medical need is very high.
ASP0367 is a selective PPAR-delta modulator discovered by Mitobridge, which we acquired in 2018. This activates a gene expression program to expected -- to produce proteins essential for mitochondrial activity. Now clinically, it is confirmed that the ASP0367 increase the expression of PPAR-delta target genes and enhance the mitochondrial function. And it was confirmed that this showed dose-dependent increased expression of PPAR-delta target genes and in healthy adults in a Phase I study. Currently, Phase II/III study for PMM patient is under preparation. And also, this is being developed as a treatment for DMD.
Now Page 16. This is cell therapy, ASP7317, an update of that is here. For cell therapy, ASP7317, which has been developed for that indication of dry AMD. The protocol amendment of the ongoing Phase Ib/II trial is currently under discussion with the FDA to optimize the entire development program. There are 2 reasons of having this discussion with the FDA. First of all, this development, based upon the instruction from the authority, this protocol is targeting the very severe visual impairment patients. They are quite severe in terms of the vision impairment. We've identified them. And however, originally, the number of such patients is quite limited, and screening failure rate is high. Therefore, feasibility is really poor. That was identified. And also, at the time of the transplant of the cells, immunosuppressive drug is administered. Because of this, immunity is suppressed. And now we are in the problem of the COVID pandemic. And in order to avoid the infection of COVID-19 because of the threat of the infection, the screening and enrollment was suspended. In light of this situation, we are discussing a revision of the study protocol with the FDA for strengthening the entire program further.
We expect that the FDA consultation is going to come to agreement soon. Immediately after that, we post the latest information onto the clinicaltrials.gov. But that update is likely to take place between this time and the next financial announcement. So what we are telling you here is pre-announcement. So please be mindful about that.
Now Page 17. Another focus area that is ASIM Biology, that is antigen-specific immunoregulatory. A LAMP-vax technology, which is the basis of this primary focus, and this has reached a stage of clinical validation of 2 projects, ASP0892 and ASP2390. And also, as the next-generation immune modulation technologies, that has led us to identification platforms with mechanism, modalities distinct from ASIM and the research for innovative therapeutics by utilizing endogenous homeostasis mechanism has been started. So this next-generation immune modulation platform, immune homeostasis is going to be the new candidate of primary focus and continuously, we'll commit to the field of this area of the development. ASIM Biology has a primary focus with using LAMP-vax technology. Already, that road to develop the project is completed. Therefore, ASIM Biology is now excluded from the primary focus. But the currently ongoing clinical trials are going to be continued. So for new one, that is going to be the primary focus candidate. So as a result, the 5 primary focus is going to be tentatively just 4. Now Page 18, major pipeline events expected in 2020. As has been explained, the enfortumab vedotin, PADCEV pivotal test results-based submission of NDA is planned to be conducted within this fiscal year.
Slide 19. After this, I'm going to talk about the progress of Rx business. The progress from the previous financial results announcement in August this year is underlined. Upper row, Regarding Fit-eNce, which we announced this is starting original sales in the first quarter financial results announcement, started service from September 1 through a fitness club in Kanagawa Prefecture. While observing the status of trial sales cells, we will determine whether to expand it nationwide. In the middle, under development as an optical imaging and precision guide, ASP5354, that is going to be touched upon later. The bottom, Astellas has been conducting joint research and development with iota Biosciences with the aim of putting the smallest implantable medical device into practice use. We have agreed to acquire iota Biosciences. For this as well, I'm going to explain the details with the following slide.
Page 20. 5354 Fast Track designation information is described here. Iatrogenic ureteral injury, or IUI, is caused during abdominopelvic surgery. The mortality is high, and a longer length of hospital stays is encouraged. Therefore, that incurs further health care costs and unmet medical need is really high. It is reported that if the position of both ureters can be identified intraoperatively, it will be useful to prevent IUI. But so far, there is no easy way to do so.
ASP5354 is precision guide to make it possible to visualize the ureter in patients undergoing hysterectomy or abdominopelvic surgery. With the preoperative administration, the position of the ureters are identified preoperatively, and it is expected to lead to minimizing the risk for IUI. The other day, this was administered for the case and the picture, the images at the time, is what you can find on the right bottom chart. As you see it in here, even in a nonclinical trial and also in these clinical trials, it is indicated that this technology could visualize both ureters. Fast Track designation was granted from FDA. So we would like to put out more effort into the development of this for earlier commercialization.
Page 21 is about the acquiring of iota Biosciences in the United States. And since the implantable medical device can be directly implanted in the appropriate target site, it is expected to reduce systemic side effect and show clear therapeutic effects. However, traditional implantable medical device requires the power batteries, cable for communications, and also larger electronic circuits are used. So it is difficult to make that size smaller. So in many cases, highly invasive procedure being necessary for the implantation. iota has made it possible to miniaturize embedded devices by enabling power transmission from outside of the body and by directional data communication using ultrasound. This enables the super small body of the product. With this, local biologic sensing and electrical stimulation from a device will be possible. In the future, by combining sensing and stimulation, we expect to develop into closed loops and autonomously control the treatment system that can constantly monitor the state of body with a sensor and apply stimulation when needed.
We believe that this technology may lead to the development of new implantable medical devices and have been conducting joint research and development since August 2019 jointly. This time, Astellas acquired iota, and we have acquired the world's top talent in their basic technology and bioelectronics field. In this way, we will expand and accelerate the joint research and development that we have been promoting on a project basis. Furthermore, we aim to be a center of excellence to make iota's core technology and human resources in this field as a core base of to Rx+ business.
So last year, as the strategy, a direction for the targeting area of Rx business, Rx+ story was established. And based upon that, in order to realize that, we established the [ Sofia ]. And we are hoping that iota's technology will be state-of-the-art technology that can be applied across this sphere.
Page 22. This is the last slide from me. FY 2020 is the final year of the strategic plan 2018. We are making steady progress toward our goals, and we are making good progress in each strategic goal. For -- of the 6 late-stage development products that support short-term performance have already been commercialized and for the remaining 2, Phase III has been in progress. The focus area approach and Rx+ program, which supports sustainable growth over the medium to long term, are also expanding their foundations.
Focus area approach is exactly the key to the future of Astellas. And we hope that it will be a source of competitive advantage. The progress and achievement so far will be explained at the R&D meeting scheduled for December 10. In addition, the next strategic plan, which will start from next year, is the schedule to be announced in May 2021 when the financial results for FY 2020 is reported. Currently, it is under the formulation. So I'm not going to tell you the content. But there has no major changes in the direction of the strategy from the current managed strategic plan, which is in line with the long-term vision and the focus area approach and Rx+ program initiatives will continue to be developed and strengthened as the center of strategic goals.
From the perspective of increasing corporate value, we plan to position sustainability initiatives as one of our important strategies. So the next managed strategic plan is formulated for 5 years, which is longer than before. That's all from me. Thank you very much for your attention.
That's all for the presentation by our company. We now would like to take your questions.
[Operator Instructions] [Foreign Language] [Operator Instructions] The first question is from Citigroup Securities, Mr. Yamaguchi. Yamaguchi from Citigroup, can you hear me?
Yes, we can hear you. My first question. I'd like to know more, Page 14, enfortumab vedotin peak sales update. There is a note that this is in-market sales forecast. In the previous strategic plan, you had peak sales update for EV before. There's a mention here in the note, but your expectations are rising to this level. That's what I heard. Could you explain this note in more detail?
No. Yamaguchi-san, Okamura speaking.
At what level of revenues are going to be counted? At what level with Seagen profit sharing scheme exists?
So revenue or sales here are not sales in our accounting, but Seagen or our company are accounting these numbers based on the sales we sell in the market. So it's going to be sales to end users in the market.
Sorry, misunderstanding on my part. And the second one, TIGIT, the development has discontinued. And of course, the data is probably not satisfiable for you as a reason of the discontinuation. This is a competitive situation. So differentiation is not sufficient. Is that also the reason? Or the response itself probably in a Phase I is not meeting your expectation? Could you explain about that?
Yes, Yasukawa speaking. Thank you very much for your question. So this is the usual way for the oncology development in the initial studies. For each tumor type, how many cases, subjects are studied and you have to achieve a certain level of the response. Otherwise, you will discontinue. So we set up such a discussion -- a condition in the very beginning, and we couldn't meet such conditions. That's why we decided to discontinue.
And the last one, Rx, that is photo imaging that is by iota technologies you've introduced. So this optical imaging, in the focus-wise, it's difficult to drill an image. But how to use this? Is -- in the case of the surgery, it's like the contrast media and always use that kind of product? So the number of the sales is in line with the number of the surgery? And so the way of this using is in the surgery? So that's the basis for the sales?
Okamura speaking. What you pointed out is quite right. Basically, this is a renal excretion outside of the body quite quickly. So preoperatively, you administer this. And during the surgery, it goes through the ureter. And the near infrared is applied, so the light is emitted. And that is merged with the image in the screen of the surgeons looking at. And there, you can find the light-emitting area on the screen. That is the site of the surgery or that is the site of the location of the ureter. So of course, we have to think further about their procedures. But basically, if the number of the surgery increases where that this technology is applied, then in line with that, our sales would also increase.
iota. What kind of diseases are you assuming? Muscular diseases?
Regarding the diseases for the application, we are not disclosing the information, unfortunately. Sorry for that. But since last year, we had joint research, and the results are making progress. And that's why we decided to acquire the company.
And what kind of joint research have we done?
Astellas, in the field of ethical or drugs, has been good at certain areas. We have a lot of insight and knowledge there. And we are trying to link this to iota technologies. Then you can imagine what kind of areas we are going into. And also, as Yasukawa explained earlier, in principle, there are 2 features we're expecting from iota technologies. First is sensing, sensing the condition of the body. And before, we can do it on a stand-alone basis, but now we can do continuous sensing and indirect assessment. It's not really the case, it's going to be implanted in the body, and you can do direct sensing into the situation or the condition of the body by applying stimulation from outside. It could be nerves or muscles or with electronic stimulation. We can send stimulation signals to the body. So these are the 2 possible technologies leading to applicable diseases.
Next, Mr. Hashiguchi from Daiwa Securities.
Hashiguchi speaking. I have a couple of questions regarding R&D. First, the fezolinetant Phase III status. In your presentation, pivotal study primary endpoint, the top line result press release is going to take place soon. Is this understanding right?
Top line results, currently, we have no plan of press release. So first, 12 weeks study result, that's what we have -- we are going to have, and the study itself is continued for the safety afterwards. So the -- when safety data alone is available and do the press release, that is not within our plan.
Second is the primary focus from that. I know biology is excluded. 0812, 2392 clinical trials are not in line with what's you've expected, although it's not that was as a discontinuation. Or rather, you think that new technologies are -- rather, you are not really downgrading the value of 0892 or 2396?
Well, we are expecting higher by the new biologies. So it's not really the one antibody as a reason of the disease. Rather, we would like to explore further of the disease with multiple causes. LAMP-vax, with the pollen, the cedar pollen, it didn't go quite well. And seasonal allergy, the research was discontinued with that. And the remaining is the perennial allergy and food allergy. For peanut allergy and also house mite, what we are trying to look at now and for the future. But the other food allergies, the research was completed and some representing food allergies, well, research was completed already. For peanuts, if it worked well, then depending on the data, we could work for other allergy as well. Having said that, the research, that is already completed. Therefore, this time, LAMP-vax using research is decided not to be continued.
Then those using LAMP-vax technologies, for example, 0892 is going to be successful, then what's coming into the clinical stage may increase a bit more?
Yes. You can think that way as of now.
Understood. Lastly, ASP7317 protocol amendment. As of now, at the earliest, when you will get the data as a basis for the submission in the earliest scenario? What kind of data is necessary by the regulators in the U.S. because you don't have the experience? What kind of data and how much data and how much efficacy for approval?
There's no definitive commitment yet. Because of the circumstances, so we cannot say in which month, in which year. But based on the discussions with them, we are discussing the details for agreement. So the overall development program is now being discussed with FDA right now. We are still in the middle of the negotiations. We'd like to refrain from saying anything while negotiations are ongoing. Once we are able to conclude, we'd like to communicate.
So your response to my question is that in the next results announcement, you can share the information next time? Or you may have to start the next study without knowing that information?
By the time of the next result announcement, in the meantime, the clinicaltrials.gov information will be amended. That's what are we assuming. So without any prenotification, if there's going to be an amendment, you may wonder there can be unnecessary discussions. So this could happen by the time of the next results announcement, so this is a pre-announcement of what may come. It's going to be just the study or the Fast approval is going to be clearer, we'd like to explain when possible.
Next, Crédit Suisse, Mr. Sakai, please.
Crédit Suisse, Sakai. PADCEV is my question. So quarter 4 sales is JPY 5.6 billion. And yesterday, Seagen, Seattle Genetics, announced their third quarter financial results. And in Q4, equivalent sales is a little over $100 million, I believe. And half of this is going to be -- continue to be booked, profit sharing and also marketing -- market cost reimbursement. Is this understanding right? That's the first question.
And second, in China, PADCEV is going to be developing in China as well. But what about the scheme of the development in China? In Japan, Europe and the United States, you have already explained, I believe. But what about the scheme you've established in China? Would you please reinstate it about that? That's first question. I would go next.
Next question is about fezolinetant. You've made explanation today, but last time in the first quarter conference call, probably Okamura-san mentioned the -- is about the impact. In order to look at endometrium and you are going to increase the number of the subjects. So because of that, the cost of the drug is going to be also include to the level of the JPY 10 billion -- level of certain billions. And there was no explanation about that this time. So what's the current status of that?
And for the monitoring, I think it's going to be the biopsy. And I just wonder, biopsy has already completed or not? That's the second question.
The third question, that's going to be a no answer type of a question. AT132 update. Clinical holders are still, I think, apply -- being applied?
Okay. Yasukawa is going to be answering 2 -- question 2 and 3, fezolinetant, endometriosis. In order to confirm the safety, the number of the subjects is planned to be increased and that is exactly what Okamura explained in the first quarter announcement. And at this time, we believe that we have a number of the patients that cover what we've expected. That's why screening is discontinued. Once we do next month toward the FDA, clinical hold response is planned to be submitted. Then Matsui is going to answer for the first one.
Regarding the first question, let me respond. In the United States, the booking of the revenues, as you said. With Seagen again, we have an agreement with them. In North America and South America, as you pointed out, revenue sales are being looked as you have mentioned. In other regions, namely China, Europe, Japan, our company would book the sales and revenues according to the agreement. So you're right.
Understood. AT132. Next month, to lift the clinical hold, you're going to send your proposal to FDA from your side?
Yes. A response document will be sent to FDA next month.
Understood. So for the next result announcement or the full year results announcement, you may be able to answer, perhaps?
Once we send a response, it's going to be -- the ball is going to be FDA's court. If there's going to be no additional comment, a clinical hold would be lifted. If there is any concern by FDA, there can be additional inquiries. We will report the progress, but when the clinical hold would be removed, we cannot say anything definitive right now.
Next, Goldman Sachs, Mr. Ueda.
Ueda from Goldman Sachs. First, the question is about XTANDI. In the first quarter and after that, there are some changes. Well, in the United States, this is not really increased, but it seems that business is favorable in established market. Looking at each quarter base, there are various factors in both. That's what I understand. But recently, especially the United States and the established market, what's the current progress or update?
Thank you for the question. Matsui would like to answer that question. Just like you pointed out, in Q1 and Q2 sales in the United States, the Q2 is seemingly a bit worse. But in actual demand as situation as long as I know, there was no decrease. I think it depends on the buying pattern. For Q1 -- in the previous Q1 announcement, I'm not quite sure if it was after not. But as for the inventory level, that is within the normal range. However, it's a bit higher than the usual inventory level. But toward the end of Q2, although it is in a normal range, but it's a little bit lower within the range. And the current 1-day sales of XTANDI is exceeding JPY 1 billion. So with a couple of days difference in the inventory, it has certain level of the impact in the difference between first quarter and the second quarter. Therefore, actual demand and sales is quite as has been planned. When it comes to Western or European market, as has been pointed out, under this COVID-19 situation, just like the case in the United States, the patients are still -- severe patients, should they come to the hospital or clinics to receive the prescription, I believe that's the situation because sales is increasing.
My second question, on Page 14, you talked about PADCEV peak sales expectations. You have new clinical data? And also invasive bladder cancer, peak sales potential is now included. So what is raising the peak potential sales?
There's a substantial increase this time. So could you elaborate on this? And the timing of the data disclosure for PADCEV, ASCO GU next year is going to be the next timing of data disclosure for PADCEV?
Matsui speaking, I'd like to comment. First of all, as you pointed out, MIBC, we started new studies, and we will have sales there. It was not commented, but last time, sales in China were not included. But this time, sales in China are included. Last time, we haven't started the studies yet, but now we have started. That portion is now reflected. And also since the previous time, market survey was conducted. Market research was conducted. And new data is becoming available. We have 2 new types of data. To interpret the data, as Yasukawa presented before, product profile, we expected -- in the current product profile, we are now changing to more realistic product profile. Various penetrations and evidence stories have been reinforced. So there's going to be an upside. We can aim higher. So these are the 2 -- 3 factors resulting in upside. Peak sales are expected to grow further, and we are more confident. That's why we are disclosing this figure.
What about the next data disclosure timing?
Kitagawa is going to answer to it. ASCO GU and other appropriate timings are considered for the information disclosure. As of now, which congress, which opportunity, we cannot tell you. But 301 and also 201 cohort 2 study results, those are going to be disclosed at an appropriate timing.
Understood. The third question. That is about the fezolinetant. Basically, you look at the safety and the announcement will be made after that. But SKYLINE 1, 2 and 4, the timing of the end of the studies are different. So the next timing of the announcement, when would those be?
Probably next year, April, August or December, according to the clinical trials schedule.
And also, what about the later remitting of factors of the NDA submission? Or the NDA submission will be when all the studies are completed?
Yasukawa speaking. As of now, for each of the study, I cannot tell you exactly when or which month. But the safety data, as long as we've learned, we would like to announce that for each study. And so the NDA, the first drug and such as special occasions are not applied for this. So this is going to be ordinary procedure of the submission. So all the necessary data has to be included in the dossier. So SKYLINE 4, the full study is going to be the rate-limiting factor. But as we mentioned, the end of the screening, that's already completed. So the last patient is going to go into first visit. Then after that, the 52 weeks, the study will be continued according to the protocol. So around this time next year or a little later, last patient, last visit will happen. Then after that, database is cleaned up. It's going to be cleaned up, and the result is compiled. And for each of them, papers will be written. And after that, integrated safety -- integrated efficacy analysis would take place. So that is the final stage in the normal schedule of the development. And a couple of months after that, we are going to do the submission. That's what we are thinking.
Next, Morgan Stanley, MUFJ, Mr. Muraoka.
Morgan Stanley. My name is Muraoka. Many questions already asked. But regarding PADCEV, sales were announced this morning. Short-term [ up-down downs ] about $62 million in the United States between July and September. I didn't listen into the conference call by Seagen. I don't have to worry, but could you explain the background a bit?
Matsui speaking. Let me comment. It may look a little flat.
But any particularly negative element?
No. That's not the case. In this case, there was a quick uptake at the beginning. So at one point in time, in summer of this year, it might have become flat. But as far as we know about the market data, the indication, third-line use, already, very high share is being obtained with the prescriptions, and awareness is increasing. So we are not aware of any major negative factors as of now.
Understood. And also, fezolinetant data that is repeatedly asked already. So data of efficacy is going to be available one after another, but do you have to wait for 1 year?
From the perspective disclosure, I don't think it is favorable not announcing such data. For example, the next quota announcement, some rough feeling of the data is going to be disclosed. Still waiting for the safety data though. Is it possible to give us the information in that way or in the new ones in the next announcement?
Thank you for your comment. Well, that's the request acknowledged. To what extent we can respond to that, we would like to consider further internally. But please consider that favorably.
Regarding your results, core operating profit, JPY 251 billion. This time, the JPY 130 billion. In the second half, you have higher costs according to your tendency. I think it should be okay. But the profit level may not be so satisfactory. 6 months ago, Okamura-san said you'd like to have an upside for JPY 251 billion, if possible. Any possibility of an upside from here? How do you evaluate this level of JPY 130 billion? Can I have your comment please?
Okamura speaking. First of all, in the first and the second quarters, the impact of COVID-19 affected these periods, including -- which were included in the past 6 months. And the progress against the full year forecast is about 50%. That means that 50% of the full year forecast for the drug, if there's going to be recovery in the second half, we can expect sales more than the past 6 months in the first half. It's not flat of 50%. There was a dip, and it's going to recover. And we're achieving 50%. So it's -- the progress is better than the original 6-month period. The use of spending is going to concentrate more in the second half. You're right in your comments. But we try not to do so as much as possible. Instead of using our money at the very end of the fiscal year, we need to improve the operation we have been doing so before, and we will continue to do so going forward as well.
The balance between the first and the second half in the past, it's not the level you should be too concerned about. Compared to the past 6 months, an upside for the sales and revenues and because of the increase in upside from the promising new products, so we don't have to worry about the bottom line. In particular, core operating profit, there is no need to worry in my view. Am I answering your question?
Understood. Clear.
Next is Tokyo [ Kaisho ] Asset. Mr. Mizuno, please.
Hello?
Yes, we can hear you.
I have couple of questions in enfortumab, MIBC. For 03 study has cohort H and J. So you have other studies ahead of this. But what's the kind of status of cohort H and J? If those studies are ongoing, then later, we will see the data of these 2 cohorts in MIBC? So you joined with the study conducted by Merck. In that case, the cost of the clinical trials are going to be covered by Merck mostly?
Kitagawa is going to answer that question. First of all, the first point. Cohort H, J for 103 study, those are still ongoing. So KEYNOTE-905, in line with that, these 2 studies are going to be continued. And as the cost of the 905 study, currently, the expenditure or the cost structures are not disclosed. So we would like to refrain ourselves from disclosing that to you.
So cohort H and J, if they make success or not, and the continuation of 905 study, those are okay to considered an independent manner?
Well, both the H and J, those are monotherapy. Those look at the efficacy of monotherapy. 905 is the combination with pembrolizumab. So those 2 are not exactly independent, but a result of either the Phase II would do not have impact on that of those 2. These are different treatment options.
Peak sales expectations are increased to JPY 400 billion. This is multiplied by the probability of success? Or is -- this is going to be successful? That's your assumption right now? I might have asked this question before, but for confirmation, let me ask again.
Matsui speaking. Potential peak sales. We are not multiplying this with probability of success. This is our expectations for this product, which are rising.
Understood. One more point, iota. I haven't studied this area sufficiently. Sorry for that. But in this field, leading talent was acquired in this field. That's what I was able to understand. And how -- leading talent amongst many players in this world or is this a niche area? I can't get the clear image. Could you explain in a maybe qualitative fashion?
I haven't counted the number myself, but this reason, we'll go to bring the [ change interface ] in the end by counting how many scientists are into this field of research. A substantial number, I think, we acquired iota. And co-founder and co-CEO right now, Michel and Jose at UC Berkeley, they were teaching -- they were the leading experts in this field. And those who study under him are scientists and engineers who studied under the 2.
By the way, iota, where is the physical location of this iota?
Berkeley.
[Operator Instructions] [Foreign Language] [Operator Instructions]
Thank you very much. It seems there are no further questions. So with this, we would like to close this financial announcement meeting. Thank you very much for your participation. Thank you.
[Statements in English on this transcript were spoken by an interpreter present on the live call.]