Shionogi & Co Ltd

Hello, everyone.

My name is Kyokawa from Public Relations Department of Shionagi. Thank you very much for joining us today. This is the briefing for the financial result of the Q3 of fiscal year 2023. From Shionagi today, we have Dr. John Keller, Senior Executive Officer, Senior Vice President, Supervisory Unit. And then we have Dr. Iwasaki, Senior Executive Officer, Senior Vice President, Healthcare Business Supervisory Unit in Pharmaceutical Commercial Division. And then Dr. Ryuichi Kiyama, Senior Executive Officer, Senior Vice President, Corporate Strategy. And then Dr. Uehara, a corporate office, a senior vice president, and then we have Masako Kudo, vice president, finance and accounting department. Today, Kudo is going to brief you on the financial results for the Q3, and then Dr. Kiyama is going to explain our undertaking for the future growth. Then we'll have Q&A session. We are planning to end the session at 4 o'clock. Now let me explain simultaneous translation. Simultaneous translation is available for this session today. If you wish to use simultaneous translation, please click the globe icon at the bottom of your screen and choose either Japanese or English. Now let us start, Kudo-san. My name is Kudo. I'll give you the briefing of the financial result of Q3 and the amendment of the forecast. Now page 4. This is the actual. The 338 billion for revenue with the profit operating profit of 146 billion. And then the net profit 198 billion. As to the Koba, we booked 100 billion for the Koba. And for base business, it's been going very well. So as you can see at the right, as you can see, the revenue and other profit categories are achieving higher figures as compared to the previous year. This time we are indicating how many times we've increased our revenue and profit. And the progress as of Q3 is going very well. We've already achieved the forecast at the time of the Q3. So we are going to revise our forecast upward again. And also the corporate operating profit and profit before tax and profit attributable to owners of parent have already achieved the record high. Page five. This is statement of profit and loss. As to revenue purchased by the Japanese government was booked for the third quarter. And as to other products, the tendency or the trend is same as Q2. In addition to Zocoba, HIV royalty has increased as well because of the good sales and also the favorable exchange rate. And also, Cecily Delco is selling very well in Western countries. As to cost, it's very difficult to forecast the cost of COVID-19 products. So the progress rate is 55.7% for this. And this has been factored into the revision of the forecast. The cost of sales and SDA, as we have invested heavily, but the overall expense has been well controlled. So the operating profit is 146 billion, and it's already exceeding 120 billion of our original budget. As to financial income and costs, it's 52.3 billion, and it's increased a lot from the previous year. This is thanks to the increased dividend from BIB. The timing of the receipt of the dividend has shifted to April. That's one factor. And Weave is doing very well. Because of the reasons, we are now having very good figure. And the dividend is fluctuated because of the cash available at the Weave. Because of that, we are very conservative, but the progress rate is more than 90%. As to profit before tax and profit attributable to owners of parents, it seems lower than the previous year, but last year there was a one-off factor of return money from Osaka tax office. And this is revenue by segment. As to prescription drug in Japan, The actual between April and December is 54.7. It's a big down from the previous year. This is because of the Injunib and Vivance. They are doing well. However, because of the generic of Simon Valter and also because of the return of the anti-influenza, the sales declined. As to progress rate, it's 71.5%. It seems lower figure. However, The weight of this infectious disease is big in the fourth quarter. Therefore, it's on track for Q3. NSG overseas subsidiaries and export, it's going very well. As to Shionagi Inc., it seems like same as the previous year, but there was 2.2 billion of one-time revenue for the last year. But this year, we are seeing a big increase because of the sales of Petroza. As to contract manufacturing, it seems delayed. However, on the full year, there will be no difference from the budget. As to OTC, because of the eighth wave of COVID-19, it's going very well. As to royalty income, Continuing from the second quarter, HIV franchise, it's going very well in terms of the sales, and also there is a favorable effect of the exchange rate. So it's going very well. As to CRESTO for this year from AstraZeneca, we didn't factor in the royalty from AstraZeneca, but it's selling very well globally. Therefore, we received 1.3 billion as royalty. As to COVID-19 related products, the purchase of the Zocoba by government, that was 100 billion. 10 billion more is necessary to achieve the target. And we will try our best in Korea and China so that we can achieve our target. Page seven.

This is the revenue forecast for prescription drugs in Japan. With regard to the revenue of this, as I have said, it is smoothly progressing. With regard to influenza family, in the second quarter, there were some returns. So it was minus 3.8 billion. But as it says in the notes, there was a revenue increase of 1.5 billion from April to December. The next page, this is the results and progress in Q3 of FY 2022. What I would like to tell you is that we are finally able to deliver the COBA to our patients. Up to now, to COVID-19, we have conducted much investment, and at least this is contributing to our revenue and profit. And also with regard to vaccine S268019, we are conducting the submission for the approval and we have been able to attain a great progress. With regard to the settlement in the cost and also SGA in the COVID-19 related financial forecast, there were a lot of uncertainties. Therefore, we had a very conservative forecast. However, we were able to exceed our forecast. And now I would like to explain the financial forecast for 2022. This is regarding the changes in earnings forecast. In the HIV business, we are doing well, and there is a royalty from the HIV, and therefore we are going to revise our forecast. zocoba's cost and also because of the volume increase of the manufacturing the cost ratio has increased or improved with regard to general and administrative expense in order to prioritize kobe 19 related business some of the originally planned growth investments will be shifted to the next fiscal year and also It is there is going to be a proactive investment and increase in R&D expense in order to cope with the R&D expenses. Aggressive investment in product development, including COVID-19 related projects. Page 11. Because of. there were uncertainties in the past. I said that there is going to be a revision in the forecast And because of the clarification of the zelkova and the HIV business situation, we are going to implement the second upward forecast revision. It seems like there is not much a difference in the forecast, but because of the zelkova business in Korea and China, STS 2030 update will be conducted and also the forecast will align with that forecast starting from April. And this is a forecast that we are quite sure that we would be able to attain. and therefore further increase in sales may be expected from overseas, a progress of the COBA, and reflecting this situation, the second upward forecast revision will be conducted.

Page 12 is the revision of earning forecast statement of profit and lost. Revenue and all the profit categories are upgraded. Page 13. This is revenue by segment after revision. As I explained, royalty from Weave and also royalty for Crystal for AZ have been incorporated. Then we are going to achieve our target. And for the next year, we would like to achieve further increase of both sales and revenue. As to the COVID, we believe that we are going to increase the sales further. COVID-19 will be categorized as category five. And as because of this change, I think more people would use a product. And we also like to negotiate with the government about the storage of the product. And depending on the situation in China and Korea, we may further increase our sales. And also we are thinking of getting approval for vaccination. In April, we are going to update our mid-term plan and EVD activities will be done very actively. There are many other items that we cannot disclose now. However, we are taking a lot of measures and please stay tuned. That's all. Thank you very much. Now we are going to, Kiyama is going to talk about for the Q3 and the growth for the future. This is about the Koba. And this is the summary and page 16. And because of the approval last year and for Shionogi getting approval is not the start. It is a start, not the end. As the new variant comes up, the role of the antivirus is increasing, and we believe that there will be strong needs. Shionagi is going to sell the COVID globally, and we will also focus on pediatric and prophylaxis. And then long COVID, we are going to gather evidence so that we can contribute to the normalization of people's lives. As to the coexistence with the COVID-19, we will continue to take measures to fight against COVID-19. And using the following two slides, we are going to explain the situations.

This is the Japanese situation for Zocoba. Supply from government purchase is different from the normal sales, and we have been able to deliver Zocoba to more than 20,000 patients in Japan, and there is no major safety concerns. uh for the future uh we are under discussion with mhlw and pmda for general approval and also the phase two uh phase three part of the phase two three trial conducted in japan and asia the data of that will be announced at academic conference We will talk about the long COVID follow-up interim analysis results and antiviral reduction effect around February of this year. With regard to Zocoba in Korea, we have submitted an approval application on January 3rd of 2023. Initially, we were going to aim for approval under condition, but right now we are continuing discussion with Korean government and regulatory authorities, and we are aiming at approval by... fourth quarter of fiscal year 2022. And next is the global study situation for Zocoba. With regard to Scorpio HR, we are increasing site outside of the United States. And in 2023, we are aiming for completion. and also STRIVE trials for the hospitalized patients. We will be starting this trial in February of 2023. And also SCORPIO PEP trial. Right now, we are continuing protocol discussion with PMDA and FDA, and we will be starting this trial in February of 2023. Next, with regard to zircova in China, There is a greater need for the clinical trial, and right now Pinyan Shionogi is preparing to apply for NDA. After we have gained approval, we want to be able to deliver zocoba as soon as possible, so we will provide the product from Japan initially and then switch to domestic production in China as soon as preparations are completed. And also, with regard to the construction of the production system, we have completed PV at drug substance and formulation plants. Right now, we are aiming to build a production system to supply more than 20 million people a year, and 100 million production capability is also available at this point. And also with regard to the supply and sales system, A license agreement for import and distribution with shop part and license agreement for promotion with a CTTQ has been. Pro has been conducted and with this we would like to. And we have established a system so that we can deliver a Zocoba to all of the population throughout China. Next is the pipeline progress. In total, the development is in progress smoothly. And today I would like to highlight on S309309 and Allorafilm. With regard to Sano 309309, this is an indication of obesity and it's a mechanism different from GLP-1 for obesity. With regard to S309 and 309, it can be provided at low cost, and with a non-clinical study, there is an expectation for high efficacy, and it can be combined with GLP-1 as well. So we will be able to deliver another option for treatment, and therefore, we are aiming at a global development. And also, we have not seen any adverse events of any concern so far, and there is a high tolerability as well as efficacy. Based upon this good study result, we are going to conduct a global phase 2b study. Next is the Olorofim. It is a new mechanism of action, and its indication is a limited treatment options for invasive fungal infection and invasive aspergillosis. F2G is conducting a phase 2B study right now, study 32, and its mid-term result has become available. Study 32 is for any limited treatment options for invasive fungal infections and invasive aspergillosis of patients who do not have any other treatment options. So it's an open-label study in patients with limited treatment options. And you can see that the results 87% is the death rate for the control. However, with Allorafilm, this rate has been reduced to 32%. So as you can see, the efficacy, including high survival rate, was shown and also It was well tolerated, even with dosing up to two years. Therefore, NDA based on positive results is underway, under review by FDA at the moment. And we will be making steady pipeline progress, including these two progresses. And next, I would like to explain about the progress of HIV franchise by VIVE Healthcare. As you can see from the financial report of VIVE, their sales is increasing, driven by the HIV franchise. With regard to Doveto, the sales was 360 million pounds in Q3 2022. It was an increase of 73% YOY. And as you can see for each quarter, it is increasing, and it is offsetting the decline of the others. With regard to Kevenuva of June, the Q3 2022 sales has been over 100 million pounds. With regard to Apretude, which is a long-acting injection for prevention, It will be an important growth driver going forward, and up to 2026, towards 100 billion pounds goal, it will be growing steadily. And also if 4365598 it is penetrating into the US market very smoothly and also we will be going into the European market and that we are expecting a growth that was with regard to upper etude. Sorry and next is with regard to S365598. It is a ultra long. acting injection and phase one trial has been initiated already in December of 2022. It is a oral administration formulation and the steady growth of innovative portfolio and development progress of next generation long acting products to dry medium to long-term growth can be seen. Next is with regard to the development status of the combination candidates for ultra-LA injection. As you can see, these are not compounds developed by Shionogi, but they are the combination candidates for our LA injection. Virus resistance should be prevented by combining with other drugs, and therefore, we need to develop combination drugs, and Vive Company is right now developing five compounds as combination candidates. And today, I would like to give you a progress report on broadly neutralizing antibody 96LS. By blocking HIV's entry into human CD4 positive cells, the HIV transmission process may be prevented by this 96LS. and a single infusion of 96 ls demonstrated strong antiviral efficacy while uh being well tolerated by the participants and also we expect to begin a phase 2b trial of this n6ls in combination with and other antiviral retroviral in 2023 that is all from myself thank you very much

Thank you very much. Now the floor is open for Q&A. If you have any questions, please raise your hand. And please, down your hand after asking questions. First, Mr. Kotani from Nomura. Kotani from Nomura, do you hear me okay? Yes? about the COBA, as you mentioned, after becoming category five, I think there'll be spread of COVID-19. We've used a lot of the drug for influenza. So I think people would use it for the COVID-19. And the reason why Because we are using a lot of anti-influenza is that in order to lower the risk, there is long COVID problem as well. So I think people would use it. And as compared to influenza, there was no selling of the antigen tests. But now, antigen test is available for people And if the government subsidy maintains, I think it would be easier for COVID-19 products as compared to influenza. But there is also a negative scenario, and the current share price is reflecting that. So I have a question to Igarashi-san. It's categorized as category five. What would be the potential reason why it wouldn't be used if there is any reason for Zocoba to not be used? Thank you for your question. As you mentioned, as to Zocoba, as influenza, regardless of risk factors, once people get positive they would receive the medicine so that they can prevent the spread of virus and to decrease the conditions not only the patient themselves but also their family members and community as a whole can be benefited thanks to this drug And that's how we obtained our data. Therefore, as you mentioned, after getting emergency approval, it would be shifted to regular distribution, and then it would be easier for people to get access to this product. And you asked if there is any negative scenario about the COVID if there is any potential scenario where people wouldn't use that product, the COVA. And that would, so far, more than 20,000 people use this drug, and we now have accumulation of safety data, and there's no concern about safety so far. Therefore, I think that people would continue to use the cover. But if something happens in terms of the safety, then, of course, doctors may not prescribe this drug to low-risk patients. However, we don't see any signal. But if you ask, that would be one factor. I hope I answered your question. Drag, drag interaction. What about drag, drag interaction? But I don't think that would be a problem. Now, under the situation of emergency approval, there are complicated processes such as informed consent. Therefore, some hospitals and and pharmacists are not using this drug. However, once it's shifted to regular distribution, it will be easier to prescribe the COVA. And as you mentioned, for young people, they don't generally use other drugs. And once they get used to it, then they can immediately check if there is any problem in terms of DDI according to the feedback from a doctor. So I don't think that would be a big problem.

With regard to the treatment for COVID-19, so COVID overseas, I am a little pessimistic. Vietnam is complicated, but also in Korea, in China, I think on 28th of March, December, the Zocoba was not approved, and your partner's subprice declined. And after that, you have submitted for the approval. So I don't think for Korea you can expect approval. On the other hand, China, too, it has not been approved. VV-imidizavir is being announced in MDGM, and it seems that the Chinese-made drugs are being prioritized. Therefore, again, for China too, I do not have a very optimistic forecast for Zocoba in China. So what do you think about your forecast? Thank you so much. in China and Korea. Thank you for your question. So, activity in Asia for Zhukov. With regard to Korea, first of all, in Korea, our partner company has told us that For ERA, we were not able to apply, but the result of the Phase III study is data that can be reviewed. And so, as a conditional approval, we made progress with regard to the application for the approval. We were going to shift to ERA and we are expecting that we will be able to receive the review from the authority of Korea and with our data package we will be subject to discussion as to whether it is applicable for ERA in Korea. In China, the Chinese-made drug is being – gone through reviews, and we have heard that they might receive ERA in China. On the other hand, Zocoba is also applying, so the data review is being made for Zocoba in China as well. And we will be considering whether NDA will be possible in China based upon their review of our data. I hope that you can hear me. Yes. And also with regard to the phase three study, the Scorpio study, PEP study in US. What is the situation? So 72 hours after the event and I think the condition was the same as in Japan and for HR study, it was within 130 hours. So with a longer duration after event, I think there'll be more noise and therefore I I would say that the success rate would be lower for the HR study. And so, do you think that you will be shortening the duration, or do you think that you will be successful with the present condition of the hours after the event, the onset? In the global phase 3 study, the protocol is... going to be changed we are discussing with fda so that we can change the protocol and nih is fully committed with this study so nih chair and the committee will be having a discussion for this protocol discussion and therefore it might take some time but we are in the process of trying to change the protocol so thank you very much i look forward to your further feedback

Next, Ueda-san from Goldman Sachs. My name is Ueda from Goldman Sachs. I have a question about the COVID domestic market. Going forward, when do you plan to get full approval? And you also talked about long COVID. You said that you were getting information about long COVID. What kind of criteria did you use for evaluation? And as to evaluation criteria, have you made agreement with the authority? Thank you for your question. About the process of the full approval or regular approval, together with MHLW and PMDA, we are discussing the schedule. So we don't have the specific dates or schedule yet.

As you know, the emergency approval, there is a condition that we have to get full approval within a year.

So we have to submit all the data so that we can move on to the regular approval process. About your second question about long COVID. We've conducted phase two and phase three and all the patients in this study after one month, three months and six months, excuse me, three months, six months and 12 months at each time point. We check if they have any long COVID conditions.

It may not possible to get answers from all the patients, but the feedback ratio is very high in Japan.

The result of the feedback will be analyzed, and then we are going to announce that figure in February.

We looked at 12 conditions.

and also hearing and smelling, taste and smelling, and also other psychological or psychiatric long COVID conditions. We ask them if they have such conditions, and we also ask the grade of those conditions. We will analyze those information, and then we'll see in which way we can lower the risk. And that information will be disclosed soon. Thank you very much. Was it a blinded study? And as to those criteria, have you made agreement with the authority? It was an unblinded study.

Because

They don't know if they're having active drug, but the key has already been opened, so this is the unblinded test. And as to long COVID, the definition of the long COVID and also any effectiveness of treatment, there is no fixed or established ways or establish definition. Therefore, we are going to analyze the information that we are getting from this study. And then we will talk to PMDA and experts so that we can have discussion and digest or interpret the results together. You said that this is an unblinded test. And patients, do they know that they've got placebo or effective drug? If they try to get information, doctors have information at the sites. But I don't think they informed patients whether it was placebo or not. I think that they don't know which they take. That's my understanding.

So with regard to the forecast of the expenses for the future R&D. So after next year, what will be the standard or the numbers for the R&D expenses? And when we consider the R&D expenses for your company, I think Zocoba will have a great impact. So in making the plans for R&D expenses, what are your conditions that you are using? Thank you for the question. With regard to R&D expense, I will give you some figures. With regard to vaccine, the COVID-19 drugs as well, we will be accumulating evidence and also expanding indications. And therefore, in the fourth quarter and the next year, we will be conducting several studies. With regard to the expenses, the expenses will not be so large. SKS 30, the R&D will be conducted proactively and investment will be conducted proactively. But after next year, I think the R&D expenses will be similar to prior COVID-19. Thank you. With regard to the second question, could you repeat your question? Yes. The Zocoba sales will have an impact on the R&D expenses that will be available for your company. So based upon that, do you have any plans for the investment for R&D going forward?

So it will have an impact both on, to some extent, on R&D investment, but also on strategic investments for further expansion of the pipeline and other activities. So we will be obviously calibrating those expenditures along with our top line, both Zolkova sales, as well as, of course, the royalty and other factors they usually impact.

Thank you very much.

That's all for myself.

Next is Yamaguchi-san from Citi Group.

Do you hear me? Yes. My name is Yamaguchi from Citi. My first question is about the revision of your forecast. As you explained, as to the COVID, the sales remains the same, and the cost of goods was lower than the previous forecast. For other items, if it was not approved, was about 30 billion buffer in case it's not approved. This time that had been revised or is there any other upward potential? SGA, there is a buffer as the future growth buffer in SGA. But this time, there are some uncertainties about the global development of the cover. And as I mentioned, we have to strengthen our financial foundation and we want to invest in growth driver for the future. So as of now, including that buffer, that's the minimum figure that we are having now. Okay. And my second question is about the revision of the mid-term plan. Do you have any specific date? Is it in April to revise your mid-term plan? We are planning to have it next spring, but we don't have the specific date yet. My last question is about domestic decover. Lager Brio has IVMS, so you have some sales booked, and I think it's going very well. It's about 30 billion. On the other hand, Yours are still under government purchase, so we don't have any figure, and it's 20,000 people have taken this drug. But you are not able to do marketing yet. Lagebulio is used a lot, and other drugs are not used. So there is a bias or imbalance in terms of the uptake. What do you think is the reason? And do you think this situation will be resolved? And about the onset of your drug, do you have any feedback from hospitals? Onset of the effect. As you mentioned, after regular distribution, because of the public subsidy, The registration is about 10,000 or 11,000 or even 15,000, and that would increase to about 40,000. And the other factor is that in the government purchase, there is a process of patient registration. And once it gets full approval, that kind of complicated process will be eliminated. And then I think the number of patients would increase. But on the other hand, if it's categorized as five, the number of patients may increase. However, we are not sure if all DGPs would accept COVID-19 patients. That's something that we are not sure. It will depend on NHI price and the number of patients. But if we assume that we will get public subsidy, we can expect certain number of patients.

Do you have any feedback with regard to the drugs? About eight days has become seven days. So there's one day reduction and all five symptoms are being improved. And also in the clinical level, the fever declines and the sore throat has improved. So individual symptoms are being improved, and there are some doctors who are very positive with regard to that. And also, there is an advantage in preventing worsening. So once you've used it, clinically speaking, the symptoms do improve. And we have received many of such voices. Thank you very much. Thank you. Next, Curtis Swiss, Sakai-san, please. This is Sakai from Curtis Swiss, Curtis Swiss. regard to zocoba from myself as well i have two questions one is with regard to uh the so 100 billion yen for the third quarter uh that's the sales and how have you settled this based upon the vs There seems to be no changes in the BS. So, Kudo-san, could you tell me with regard to how it has impacted the BS? It's a government purchase of 100 billion, and it was divided into two occasions in the BS. With regard to the second income, It is written here in the settlement financial report. And also, again, as a cash, the increase will be seen in January. That will be the next increment. So this is a government budget. So all of the incomes will be coming in by March 2023, correct? and it will be incurred as cash. Is that correct? Yes, that is correct. So whether it's going to be category 5 or whether it's going to be subsidized, if it becomes a category 5, it will automatically become a normal distribution and So what do you think about this? Could you reorganize your thoughts with regard to how you forecast what will happen if it is recategorized to Category 5 and what will become of the subsidy from the government? With regard to Category 5 and well, sorry, with regard to the official subsidy, I think up to the next fiscal year, I think the government subsidy will continue. Maybe the amount may be declining. However, the official subsidy will continue in the next fiscal year as well. With regard to category five, the government has made the official announcement only last week. So if it becomes a normal distribution, and the listed price will change, I think our sales will increase because it will be expanded to a greater number of patients. And I do not know exactly how it will relate to category 5. So in the next price listing, will it be included in the agenda item? So the announcement was made only last week, but one of the points is that with the pandemic, the listing of the price is going to be revised, and also with the listed price, whether it is going to be unique to COVID-19 or whether it is going to be a list similar to influenza drugs is still a matter of discussion. I think the timing of the listing will be like in the normal case, but as far as how the price will be settled is unknown. So in other words, the purchasing price from the purchasing by the government will not be repeated in the normal pricing listed price, correct?

Thank you. Next from Mitsubishi UFJ, Ms. Kumagai. Kumagai speaking, do you hear me? My question is about the cover in Korea. Is it going to be government purchase? And the second question is the sales of COVID-19 products, 110 billion. And the remaining 10 is mainly in Korea. Because for China, because of the fiscal year ending, the sales will be booked for the next year. That's my understanding. Is it correct?

With respect to Korea, those aspects with respect to purchase are also under active negotiation by our partner at present. And with respect to sales.

About the sales of the China, as you mentioned, the booking period is different by three months. So the figure until December will be booked only But the sales, when the sales is significant and when the profit is booked, then that should be reflected on a statement. So it will, depending on the significance of the amount, if it's big, that will be booked for this fiscal year. Thank you. About China, I understand that they are doing rolling submission. When is the last submission and what is the expected approval date?

Yes, we are already working on the mirroring submission, and we are currently providing all the data that we can provide. We have received various introductions, so we are also providing the appropriate data for additional analysis that is necessary for such a review.

I understand. Finally, it seems that the influx of Aperture is a little slow at HIV, but is there any reason for this? Is it because of the health insurance? This is the last question.

Actually, it's a little ahead of our projections. There's two things to consider. One is, as you recall, Cabinuva launched during the period of COVID, so it took some time to set up the injection at the sites, as well as the purchase and billing processes. It turns out that the overlap between sites that provide LA treatment and sites that provide LA prep is only about 40%. So although we are now mostly outside of the COVID window, we have to do a lot of that basic work that was done for Cavanuba needs to be done for the sites for Aperture as well. With respect to reimbursement, we are on track with our own projections, but it certainly would be helpful if there is more government support for the PREP area. From a policy point of view, that is, under discussion with many positive words, but there hasn't yet been a federal strong position taken fully supporting CREPs, individual states and individual plans are. So we are hitting the trajectory we anticipated to hit at this stage, but there is, as you know, a lot of startup work still to do.

Very helpful. Thank you.

Thank you very much.

The next question will be our last question. From Daiwa Shoken, Hashiguchi-san, please. This is Hashiguchi. With regard to Zocoba in Japan, I have two questions. The first question is going forward, in order to expand as a cover one of the important points would be i think the guideline the guideline will be a revised that's my uh forecast and uh also if i think this will be a drug who are not high-risk patients and also in non-high-risk patients the judgment of non high risk patients need to be made carefully. That's what the guideline says. And in order to apply the COBA to a broad scope of patients, I think the guideline is based upon evidence. So in going forward, what kind of data will you publicize in order to revise the guideline? And what is the timing of the data which will be available, which will trigger the revision of the guideline? This is Uehara speaking. Let me respond to your question. So as I have indicated in this diagram, right now in ERA, the primary symptom is to be shortened. This is included in the package insert. So with regard to antiviral efficacy, in the second and the third phase study, all of the analysis has been completed. And so with regard to the Omicron, the phase three part data, how many hours will be necessary in order to have an antiviral efficacy is included in this study. study results, so we will disclose this. And not only this antiviral efficacy, with regard to non-high-risk patients, whether this is applicable to such patients, safety is one of the important factors that is important. And another factor is with non-risk, high-risk patients, there are many patients who suffer from the aftermath symptoms. Therefore, we have taken data with respect to those symptoms. and these symptoms will be confirmed by the specialists and by applying zakova if such aftermath symptoms can be alleviated by zakova this can lead to the promotion of the prescription of zakova this is our expectation in the the third phase apart this is uh data after the onset and three months and six months data is available today and this will be disclosed in the conference in February of Kuroi and also for longer period data we are now collecting such data. In the Congress in February, with that data which you will be announcing, do you think it will have an impact to revise the guideline, or is that too much to expect? I do not know how to respond to that question. I hope that the doctors will look into the data, and I hope that the doctors will discuss about the impact of this data to the guideline. With regard to the uh listed price i think there is much discussion ongoing and i think there is going to be a hearing from the patient organization as well and Sorry, the industry organization, sorry. And so what kind of opinions do you want the industry organization to express and advocate? This is Iwasaki speaking. The epidemic or the pandemic. The seventh wave, the eighth wave, ninth wave, when it will come has been forecasted. And based upon this forecast, the listed price is to come down. I think that's the intention. So the listed price is always ready to decline. This seems to be universal to all kinds of drugs, so they are ready to reduce the price for all kinds of drugs at any time. However, this time, this is a drug for pandemics, so I think we should advocate that point. Thank you very much. So with this, we would like to conclude the third, the announcement of the third quarter of fiscal 2022 financial results for Shionogi and company. And thank you very much for your attendance and participation.