Daiichi Sankyo Co Ltd Ord

I am Okuzawa. Thank you for taking time out of your busy schedule to attend Daiichi Sankyo's financial results presentation today. I would like to explain the consolidated financial results for Q2, which were announced at 1 p.m. today based on the presentation materials. Please see slide 3. This is what I will talk about today. Consolidated financial results for Q2 strategic collaboration regarding three ADC products, FY 2023 performance and annual dividend forecast, business update, and R&D update. I will follow this order. Regarding the R&D update, Takeshita, Global R&D Head, will provide an explanation. And we will take your questions at the end. Please see slide 4. This slide shows an overview of consolidated financial results for Q2. Revenue increased by ¥118.5 billion or 19.5% year-on-year to ¥726.3 billion. Cost of sales increased by ¥29 billion. SG&A expenses increased by 66.9 billion. R&D expenses increased by 12.2 billion, all compared to the same period last year. As a result, core operating profit increased by 10.5 billion yen, or 12.4% year-on-year, to 95.3 billion yen. Operating profit, including temporary income and expenses, was ¥95.1 billion, that is the same level as the same period last year. The profit attributable to the parent company is increased by ¥38.7 billion, or 66.4% year-on-year, to ¥97 billion. As for the exchange rate performance, $1 was 141 Japanese yen. It's a yen depreciation of 7.02 yen year-on-year, and 1 euro was 153.38 yen. That's an yen depreciation of 14.66 yen year-on-year. Please see slide 5. From here, I will explain the factors behind the change compared to the same period last year. Revenue increased by 118.5 billion yen year on year. I will explain the breakdown by business unit. First, Japan business. Direct oral anticoagulant lixiana. anti-malignant tumor agent Enharts, pain treatment drug Tarije, and increased sales of Daichi Sankyo Healthcare drove a revenue increase by ¥18.7 billion. Next, I will explain the overseas business units. The figures are presented here, excluding the effects of exchange rates. Oncology business growth in the U.S. and Europe and the launch of the anti-malignant tumor drug VanFlighter in the U.S. pushed up the revenue by 70.7 billion yen. As for American region, although sales of iron deficiency anemia treatment benefit increased, A decline in sales of injectifer and ion deficiency anemia treatment and other factors led to a revenue decrease by 300 million Japanese yen. As for EU specialty business, due to growth in sales of lixiana and hypercholesterolemia treatment Niremdo and Nastandi, revenue increased by 6.3 billion yen. As for Asuka Business in charge of Asia and Latin America, due to growth in Enhatsu mainly in Brazil, revenue increased by 11 billion yen. Enhatsu and Dato DXD upfront and quit payment regulatory milestones and sales milestones were booked last year in a manner that the total amount from the time the contracts were signed until the milestones were achieved was booked as revenue all at once because of this revenue decreased by thirteen point four billion yen the overall impact of foreign exchange on revenue was twenty five point five billion yen Slide 6 shows the factors contributing to changes to core operating profit. I will explain the 10.5 billion yen increase in profit by item. As I explained earlier, revenue including an increase of 25.5 billion due to the impact of exchange rates increased by 118.5 billion yen. Next, I will explain the cost of sales and expenses excluding the impact of exchange rates. The cost of sales increased due to an increase in revenue by ¥22.9 billion. SG&A expenses increased due to an increase in profit share with AstraZeneca related to Enhaus by ¥56.8 billion. R&D expenses increased due to an increased R&D investment in 5 DXDA DCs by 5.7 billion yen. The total cost increase due to exchange rate impact was 22.7 billion yen. The actual increase in core operating profit excluding foreign exchange impact was 7.7 billion yen. Slide 7 shows the increase and decrease in profit. Core operating profit was, as was explained earlier, increased by 10.5 billion yen, including the effect of foreign exchange rates. As to temporary revenue and expenses, due to the effect of the gain on sales of products and subsidiaries in China in the previous fiscal year, it was a decrease of 11 billion yen year-on-year. As to financial income and expenses and others, the increase in interest income and improvement in valuation of investment securities and foreign exchange gains had a positive impact of 11.4 billion Japanese yen year on year. Regarding corporate income tax, etc., while profit before tax increased, quarterly tax expense calculated with the simplified method as well as the impact of the tax effect accounting associated with the transfer of Daiichi Sankyo ESFA contributed to the decrease by 27.9 billion yen year-on-year. As a result, profit attributable to the owners of the company was ¥97 billion, an increase by ¥38.7 billion year-on-year. Slide 8 and 9 show changes in the revenues of business units and major products in Japan on a yen basis, whereas slide 5 showed the situation of each unit excluding the impact of fraud in exchange rates, but here its impact is included. Next, I would like to give you an overview of the strategic collaboration agreement with U.S. Milk for HER3-DXD, DX7300, and DX6000, which was recently concluded on October 20th. Please see slide 11. Daiichi Sankyo and U.S. Milk will co-develop and co-commercialize HER3-DXD, DX7300, and DX6000 worldwide, excluding Japan. By collaborating with U.S. Milk, we will accelerate and expand the development of the three products and maximize their product value and at the same time allocate resources quickly and flexibly to the next growth driver after 5 DXDADCs, post-DXDADC modalities, etc., Mono and combination therapy for the three products will be co-developed, and U.S. milk will bear 75% of the development expenses up to $2 billion for each product, and subsequent development expenses will be split equally between the two companies. In terms of sales, the two companies will jointly commercialize the products in regions outside Japan and split U.S. The gross profit and sales promotion costs and so on equally. In Japan, we are the sole marketer of the product and will pay royalties to U.S. milk. Revenue is booked by Daiichi Sankyo in all countries and regions where we have footprints, including Japan, and Daiichi Sankyo will manufacture and supply the three products. Slide 12 shows the financial terms. Through this strategic collaboration, in total, Daiichi Sankyo will receive up to U.S. $22 billion or 3.3 trillion yen at exchange rate of 150 yen to the U.S. dollar. The upfront payment is 1.5 billion U.S. dollars for each of three products for a total of 4.5 billion U.S. dollars or 675 billion yen. The timing and amount of upfront upfront payment to be received for each product is shown in the table the upfront payment upon contract execution will be deferred and booked as revenue over multiple years considering the estimated period of exclusivity In addition to the upfront payment upon contract execution, we will receive R&D expenses related upfront payment for HER3-DXD and DS7300 of U.S. $500 million each for a total of $1 billion or ¥150 billion. How do we share development expenses and how cash is paid? This is quite complicated, so I will explain that with the next slide. Sales milestone will be up to 6.5 billion U.S. dollars or 2,475,000,000 yen. The sales milestone for each of the three products is up to 5.5 billion yen, which will be booked as revenue in a lump sum in a year of achievement. Slide 13 describes how R&D expenses are to be shared and how cash is to be paid. The ratio of amount paid is the same for all three products. As shown in the bottom right, U.S. milk will bear 75% and we will bear 25% of the development expenses, up to $2 billion per product. In other words, U.S. milk will pay $500 million more than when expenses are split evenly development expenses exceeding two billion u s dollars will be split equally between the two companies as shown in the upper part of the figure the method of payment of the five hundred million u s dollars borne by u s milk varies depending on the product. First, regarding HER3-DXD and DS7300, this is paid upon contract execution as R&D-related refundable upfront payment as lump sum. An amount equivalent to 25% of R&D expenses will be appropriated from this R&D upfront payment every time expense incurs. On the other hand, R&D upfront payment is not paid upon contract execution for DS6000. U.S. Merck will pay 75% of development expenses each time expense incurs in the future. The accounting treatment of R&D upfront payment will be announced once it is determined, but later when I discuss the full-year forecast, it is assumed that an amount equivalent to 25% appropriated from this lump sum payment will be deducted from R&D budget when expense incurs. Next is FY 2023 forecast. Please see slide 15.

Compared to the forecast announced in April, we expect a decrease in sales of generic injectables at American region while factoring in the forex impact of the weaker yen, sales expansion mainly by NHER2, and deferred revenue from the upfront payment associated with the strategic alliance with U.S. Merck for three DXT ADC products. The forecast has revised upward by 100 billion yen from the April forecast, to 1.55 trillion yen. While cost of sales is expected to increase due to Forex impact, it's expected to increase only by 10 billion yen due to an improvement in the cost of sales ratio resulting from changes in the product mix. We expect the SG&A expenses to increase by 60 billion yen considering the increase due to Forex impact and the increase in profit sharing with AstraZeneca following in HER2 sales growth. R&D expenses are expected to increase by 15 billion yen including an increase due to Forex impact and an increase due to accelerated development of DXC ADC product lines and a decrease due to the commencement of cost sharing with US Merck for the three DXC ADC products. As a result, core operating profit and operating profit are revised upward by 15 billion yen to 155 billion yen and 150 billion yen respectively. Profit before taxes is revised upward by 25 billion yen to 160 billion yen, taking into account an improvement in the financial account balance due to rising interest rates in the U.S., etc. The current profit attributable to the owners of the company is revised upward by 20 billion yen to 135 billion yen, reflecting the upward revision of the profit before taxes. The exchange rate assumptions for the third quarter and beyond are 145 yen to the U.S. dollar and 155 yen to the euro, and the forex impact of the yen's depreciation versus the April forecast is expected to be about an 80 billion yen increase in revenue and a 6 billion yen increase in core operating profit. Slide 16 shows the revised annual dividend forecast. We will increase our annual dividend forecast for FY 2023 from 34 yen to 40 yen per share. At the time of the April 2023 announcement, the annual dividend was planned to be ¥34 per share, an increase of ¥4 per share over the actual dividend for FY 2022, based on the increased likelihood of achieving the KPIs for FY 2025 by the expansion of sales of NHER2 and other factors. In October 2023, following the conclusion of strategic alliance agreement with U.S. Merck for the three DXT-ADC products, Daiichi Sankyo will receive an upfront payment upon signing the agreement, and due to the strong performance of NHER2 and other products, The consolidated financial forecast will be revised upward. The dividend will be revised to 40 yen per share, an increase of 6 yen per share compared to the April announcement, and an increase of 10 yen per share compared to the actual dividend for FY2022. We will continue to improve capital efficiency and further enhancement shareholder returns, aiming to achieve a DOE of 8% or higher in FY 2025, which is a KPI of the fifth midterm plan. Next, I'd like to discuss our business update. Slide 18 shows a breakdown of NHER2's revenue. Product sales for the FI 2023 Q2 year-to-date increased by 93.9 billion yen year-on-year to 173.4 billion yen due to growth in the U.S., Europe, and other regions. The sales performance in each country and region will be explained later. Regulatory milestone payments for the FY2023 Q2 year-to-date decreased by 12.7 billion yen year-on-year to 4.2 billion yen due to the impacts of recognizing the amount equivalent to the regulatory milestone payments achieved in the previous fiscal year from the time of... contract signing to the time of milestone achievement as revenue in a lump sum amount. As a result, in HER2's total revenue, including upfront and quit-related payments, and the regulatory and sales milestones for the FY2023 Q2 year-to-date was 183 billion yen, an increase of 81.2 billion yen year-on-year. The full-year forecast for FI 2023 has been revised from the forecast announced in April to 433.6 billion yen, an increase of 65 billion yen from the forecast announced in April due to strong sales. Using the two slides starting on slide 19, I will discuss the sales of NHER2 in different countries and regions. First, let's look at sales performance in the U.S. and Europe. Product sales in the U.S. for FI 2023 Q2 year-to-date totaled 105.9 billion yen or $751 million, an increase of 50.5 billion yen year-on-year. The full-year forecast for FY 2023 has been revised from the forecast announced in April to ¥229.5 billion, an increase of ¥34.4 billion from the April forecast, reflecting strong sales. The current indications are as shown on this slide. Market share for each indication is also on track, with approximately 50% of new patients in the second-line HER2-positive breast cancer treatment solidifying our leading position. Chemotherapy pretreated HER2 low-expressing breast cancer also holds the top position with new patient share in the mid-50% range. And HER2 also maintained its leading position in new patient share in the second-line treatment of HER2-positive gastric cancer and the second-line treatment of HER2-mutant NSCLC, respectively. Sales performance in Europe is also on track. Product sales for the FY 2023 Q2 year-to-date totaled 39.2 billion yen or $278 million, an increase of 25.6 billion yen year-on-year. The full-year forecast for FI 2023 has been revised from the forecast announced in April to 92.8 billion yen, an increase of 17 billion yen from the forecast announced in April due to strong sales. The share of new patients in each marketed country and region is also steadily increasing, with France and Spain maintaining the top position in new patient share for the second-line treatment of HER2-positive breast cancer at approximately 60% and the mid-50% range, respectively. In the UK, the new patient share expanded to approximately 50%, achieving the top position. The share of the post-chemo new patients with HER2 low-expressing breast cancer is in the mid-30% range in France and Germany, maintaining the leading position. As for other progress, in October, we received approval for a new indication of HER2 mutant NSCLC for the second-line treatment and beyond, and we have started promotion of For this new indication, slide 20 shows and her two sales in Japan and the ASCA region. In Japan, results of the product sales for the FI 2023 Q2 year-to-date totaled ¥10.4 billion, an increase of ¥5.2 billion year-on-year. The full-year forecast for FI 2023 has been revised from the forecast announced in April to 21.5 billion yen, an increase of 1.6 billion yen from the April forecast reflecting strong sales. In August, a new indication of HER2 mutant NSCLC was added for the second-line treatment and beyond. The market share of new patients for each indication is steadily increasing, and the market share of new patients for the second-line treatment of HER2-positive breast cancer has grown to the upper 30% range, maintaining the top share. The market share of the post-chemo new patients with HER2-low-expression breast cancer also grew to approximately 20%, and it gained the top share. And HER2 also maintained its leading position in the third-line treatment of HER2-positive gastric cancer, maintaining its market share in the 60% range. The share of new patients in the newly added second-line treatment of HER2 mutant NSCLC is also steadily increasing. The results of the product sales in the ASCA region for the FY2023 Q2 year-to-date totaled ¥17.9 billion, and an increase of 12.6 billion yen year-on-year. The forecast for the full year of FY 2023 is 37.8 billion yen, an increase of 8.6 billion yen from the forecast announced in April as a result of strong sales. Product sales in the ASCA region also included co-promotion revenues in China, Hong Kong, and other countries where AstraZeneca recognizes sales. The sales performance in the region is on track, with significant revenue growth especially in Brazil, China, and Taiwan. we will continue to strive for further market penetration and expansion in the countries and regions where the product is sold, as well as to obtain new indications in order to deliver NHER2 to as many patients as possible in need of the product. Next is Lixiana. Slide 21 shows the changes in the market share of Lixiana in volumes in each country. In addition to Japan, South Korea, and Taiwan, Sales have been steadily increasing in Belgium, the UK, Spain, and other European countries. As a result, global revenue for the FY 2023 Q2 year-to-date was 137.7 billion yen, an increase of 20.4 billion yen year-on-year. For the full year of FY 2023, we expect the revenue to be 277.3 billion yen, an increase of 33.4 billion yen from the previous year. Slide 22 shows the market share in Japan in terms of monetary value. Although Lixiana's sales share declined in April 2020 due to the reduction of NHI drug prices as a result of the drug repricing for expanded use, it has since increased its market share again, maintaining the top share at 45.4%. As a result, the revenue for the FY 2023 Q2 year-to-date was 57.1 billion yen, an increase of 6.4 billion yen year-on-year. For the full year of FY2023, we expect a revenue of 112.9 billion yen and increase of 7.7 billion yen from the previous year. Slide 23 provides a major update on our patent dispute with C-Gent regarding our ADCs. In October of this year, the U.S. District Court for the Eastern District of Texas made a first-instance decision ordering Daiji Sankyo to pay Sijin the damages of $41.8 million determined in the July 2022 judgment, plus an 8% royalty on inherited sales in the United States from April 1, 2022 to November 4, 2024, when Sijin's U.S. patent expires. We are appealing this decision and are considering all legal options with AstraZeneca, including an appeal to the U.S. Court of Appeals for the Federal Circuit. The current ruling will have no impact on the consolidated earnings forecast for this fiscal year. Meanwhile, we have filed a request with the USPTO for a post-grant review, PGR, to examine the validity of CJEN's U.S. patent on the grounds that the patent is invalid. The PGR has now been reopened on the grounds that Daiichi Sankyo has presented convincing evidence of patent invalidity and a decision is expected within the next few months. We will continue to consider all measures to protect our rights. The next part is the R&D update. I'll now hand over to Mr. Takeshita, Global R&D Head.

Thank you very much for that introduction. And I'm very pleased to be giving you an update on our ADC program, also the NextWay program, as well as information about our research and development day and our news flow for the next few months until the end of the fiscal year 23. Next slide. So much of the data that we'll be talking about today is recent data that was presented at ESMO. And the first one here is about the expansion of our leadership in the HER2-targetable tumors beyond breast cancer and lung cancer and gastric cancer that you're familiar with. Recently, we reported on data from the multiple numbers of indications that we have listed here on the left-hand side as a result of two clinical trials, DESTINY pan tumor 02 and DESTINY CRC01 and 02. And these two trials led to two breakthrough therapy designations from the FDA. And it's very important to note here that these results reaffirm the potential of N HER2 as a tumor agnostic therapy. And we are currently in discussion with the regulatory agencies towards filing these data. Next slide. So here are the data from the PANTUMER02 clinical trial. And we have listed here over a half a dozen different cancer types in the response rates for each category of tumor type. And you'll see that in nearly every single case, except for pancreatic cancer here, every single case there is clinically meaningful and durable responses across a broad range of HER2-expressing advanced solid tumors. And this includes, for example, very high response rates that we can see in diseases like endometrial cancer and cervical cancer, et cetera, that you can see here, particularly in those patients who are IH3 3 plus positive. We can also see additional good responses in IHC 2 plus positive patients as well. Overall, in the ITT patient population, the response rate was 37.1% with a median duration response of 11.3 months. But among the IHC3 plus patient population, the response rate was a 61.3%, a median of duration of response of 22.1 months. These are very important numbers to look at, particularly in the context of the patients who enrolled in these trials, which are patients who had prior multiple lines of therapy and therefore had refractory disease in the vast majority of patients. Next slide. In terms of additional updates on clinical trials for the INHER2 program, you'll see here listed that in the recent months, we have obtained approval in Japan for the HER2 mutant non-small cell lung cancer in the second line setting. We have also received a recommended for approval in Europe by the CHMP in September. And we did obtain, in fact, approval in Europe for this particular indication in October. In terms of the Destiny Pan Tumor 01 study in the HER2 mutant solid tumors, the data that I just mentioned, the data was presented at ESMO in 2023, just one month ago. Next slide. In addition, I'm going to be giving you an update on our data program. And the first one here is the lung cancer program, Tropion01. Here we show you the overall efficacy in second and third line non-small cell lung cancer patients. This is the data already presented at ESMO 2023. And very important to note here that this is a positive data, positive clinical trial in which we are reporting on the PFS as part of our interim analysis. And you'll see here that in the ITT patient population, we can see positive data in terms of statistical significance, the p-value of 0.004, which is less than the pre-specified p-value of 0.008. And you'll see numerically that we can see a PFS, a median of 4.4 months versus a docetaxel control arm of 3.7 months. What is very important and quite interesting clinically to note here is the data that's shown on the right hand panel of this slide. These are subgroup analysis of progression-free survival in the key subgroups. And I want to draw your attention, particularly to the bottom, where it says histology, the non-squamous versus squamous patient population. And what you'll see there is that in the squamous patient population, the hazard ratio is 1.38. However, In a non-squamous patient population, the hazard ratio is 0.63. So therefore, almost a 40% reduction in the risk of progression in a non-squamous patient population. This is a very important event and, in fact, quite impressive hazard ratio in this non-squamous patient population. I also want to note here also that the hazard ratio for the patients without AGA versus patient with AGA, the hazard ratio in patients with AGA was 0.38. So therefore, almost a 60% reduction in the risk of progression in patients with AGA compared to patients without AGA, where the hazard ratio was 0.84. Next slide, please. So I'm going to be focusing a little bit more on these histologic subtypes, and you'll see that in the patients with non-squamous, non-small cell lung cancer, the data shown on the left-hand panel here, you'll see that PFS is 5.6 months within the data arm and 3.7 months in the docetaxel control arm with a hazard ratio of 0.63. And so the duration response and overall response rates are shown here. This is a pooled analysis of both patients with and without AGA in a non-splemous histologic subtype. And at the bottom, you'll see here that the PFS hazard ratio for the non-squamous patients without AGA was 0.71. So therefore, really what this says is that regardless of whether you have AGA or not in a non-squamous patient population, there is a meaningful reduction in the hazard ratio based on the data shown here. In contrast, on the right-hand side, you'll see the data for the squamous type non-smellsome lung cancer patients. You'll see that the hazard ratio is 1.38. And so basically what we see here is that the tremendous amount of concentrated efficacy really in the non-squamous patient population. So these data have been shown and discussed with the FDA, and we have a discussion ongoing with the regulatory agencies towards the filing of this data. First of all, therefore, that in the ITT patient population, we see a positive statistically significant data in the entire patient population, but with a very interesting and very important efficacy, particularly in a non-squamous patient population. I also want to mention here that, as many of you know, we have simultaneously ongoing right now a clinical trial called Tropion Lung 08. This is a frontline clinical trial in which data is studied, data DXT is being studied. Up until now, this clinical trial had enrolled all subtypes of non-small cell lung cancer, and we now plan to amend the protocol to cap the squamous patient population, really to focus, therefore, our efforts on the non-squamous patient population. Next slide. I do want to mention here the safety data that we are seeing in the tropion lung 01 study in terms of all grades of safety adverse events, grade three, but with a focus on what we call adverse events of a special interest that are listed on the right-hand side, stomatitis, ocular events, and ILD. Mucositis and ocular events, we believe, are really related to the TROP2 target because we don't really see that in other types of DXDA disease. And you'll see the numbers listed there. Ocular events and some of the titers are very manageable. Toxicities with various prophylaxis and also treatment of emerging toxicities. In terms of the ILD, the numbers are listed here in terms of all grades and grade three and worse. What is actually very interesting to note here is that if we do the subgroup analysis of these toxicities as well, you'll see at the bottom here, you'll see that in terms of the non-squamous patient population, the number of seven adjudicated drug-related grade five events falls out in terms of four out of 232 patients were 1.7% for the non-squamous versus three out of 65 patients or 4.6% for the squamous patient population. So there is a suggestion that there is a difference also, not just in efficacy, but also in the safety of the data analysis. when classified according to the histology, non-squamous versus squamous. Next slide. We're going to switch over to a different study called Tropion Lung 05. This is a clinical trial, a Phase II clinical trial, in which data was studied in a single agent in patients with heavily pretreated non-squamous lung cancer, non-small cell lung cancer patient population, with AGAs. So this clinical trial enrolled only patients with AGA type of non-small cell lung cancer. And you'll see here that in this Lung05 study, there's good response rate in the 30s with a very good duration response. And this data here, this is a single-line phase two trial, this complements the data that we are seeing in a TL01 in the AGA patient population that we saw in the TL01 study. Next slide. Finally, in terms of the lung cancer program for the data, the last clinical trial I want to mention here is tropion lung 04. These are data from interim analysis in which data combined with various types of chemotherapy as a doublet or a triplet is being studied in the frontline setting, previously untreated patients. These are small numbers of patients we are reporting so far, 14 patients as a doublet, with pembrolizumab and Dato, or it is a triplet combination in the cohort four. And you'll see that, however, that the response rates are quite high, 50% in the cohort two as a doublet, and the response rate of 76.9% as a triplet. And we also see a very good durability of response in terms of progression-free survival so far. So these are the basis for our initiation of the clinical trials in the frontline setting, the TL-07 and TL-08 that I mentioned to you earlier. Next slide. And finally, for the data program, I want to mention to you the Tropium Breast-01 clinical trial. This is a randomized phase three clinical trial in which data was studied in patients with hormone receptor positive HER2-low or negative breast cancers. And you'll see here the data that we reported recently at ESMO. This is data from our interim analysis in which progression-free survival was the focus of this analysis. And you'll see here positive data in which the p-value is less than 0.0001. The median PFS are shown here as 6.9 months in the experimental arm with DATO and 4.9 months in the investigator choice control arm. It has a ratio of 0.63. These are really very good numbers. And of course, we have communicated these data with the regulatory agencies and we are proceeding towards a filing. Next slide. We also want to mention here for the data program, data that was presented as part of an AstraZeneca sponsored clinical trial, the Begonia trial. And this is, what we're seeing here is just arm seven of the Begonia trial, in which the combination of Duralumab and DatoDXT is being evaluated in patients with frontline advanced metastatic triple negative breast cancer. Here you'll see that This combination, the two-drug combination of data of DXD plus duvalumab gave a response rate of 79%. And the median PFS was 13.8 months. And these are really very meaningful data when we consider that in the... The current standard in which pembrolizumab was studied in Keynote 355 study, the median PFS was, in that study, was reported to be 9.7 months. So we think that these are very meaningful data and really demonstrate the potential value of DATO and duvalumab in the setting of triple negative breast cancer. Next slide. Finally, we're going to touch on the remaining of the DXDA DCs first. the HER3-DXT-ADC program. Here, I show you the data from a pivotal registration study, HER3-Lung01 study. This is a phase two single arm study in which HER3-DXT was studied as a single agent in patients with multiply relapsed EGFR-mutated non-small cell lung cancer. And here you'll see response rates that reported to be 29.8%, median duration of 6.4 months, PFS of 5.5 months. And you can see that efficacy was observed across a diverse mechanism of EGFR TKI resistance. And I want to remind you here again that these are multiply relapsed patients with multiple prior lines of therapy. So we believe that the response rate and duration response that we see here is clinically meaningful, and we are proceeding to file the data with regulatory agencies worldwide. Next slide. Next is an update on our DS7300 program. This is a DXD-ADC directed against the antigen called B7H3. And you'll see here, we are starting to show a lot of efficacy of this DXT-ADC in several different tumor types. Going from left to right is small cell lung cancer, esophageal cancer, prostate cancer, and squamous type non-small cell lung cancer. We are in early stages of our clinical trial and signal seeking in our program already. you can see activity of 7,300 in all these four different types of cancer indications. And these response rates that we are reporting here is particularly meaningful when you consider the number of prior treatments. So again, these are patients who have multiple relapse disease, really refractory disease. And despite that, we are seeing very good activity in terms of response rates. in these four cancer types. So we are very encouraged with these data and we are proceeding to prepare registration programs for many of these indications. Next slide. This is an update on our DS6000 program. This is a DXD-ADC directed against an antigen called CDH6, which is abbreviation for Caterin 6. And here we have focused our efforts on ovarian cancer because ovarian cancer is a disease that is known to express high levels of CDH6. And here, Again, these are patients with multiple prior systemic regimens. Here you can see that the median line of prior therapy is four. And despite that, we see a response rate of 46% and duration response of 11.2 months. So these, we think, are incredibly great efficacy data in patients who are basically fifth-line patients. And so here again, we are very eager to start a registration program that would lead to approval of DS6000 in ovarian cancer. In these three ADCs that I just mentioned to you, the HER3 program, the DS7300 program, and DS6000 program, All of these three ADCs have additional cancer indications to explore beyond the one that I just mentioned to you. So there's going to be likely to be much more cancer indications, cancer types that we will be exploring for these three ADCs. Okay, next slide. Okay, finally, in terms of our DXD-ADC program, I do want to mention to all of you that we have received a Prime Minister Award at the sixth Japan Medical Research and Development Grand Prize Session. And so we are very happy and honored to have received this award from the Prime Minister of Japan. Okay, next slide. Okay, in the next few slides, I want to give you an update on the next wave, which is all of our programs beyond the five DXDA-DC that we have covered. Next slide. First is our development status of our COVID-19 vaccine. This is an RNA-based vaccine that we are developing in close collaboration with the government of Japan, really for the benefit of the patients in Japan. And here is our update. We have obtained approval in August for the booster vaccination of the original strain, which is a monovalent RNA vaccine against COVID. In September, We have completed regulatory submission in Japan as a booster vaccine of a monovalent RNA vaccine for the XBB1.5 strain for COVID. So I do want to mention to you here is that this program represents the first RNA vaccine made in Japan by a Japanese pharma using the cationic lipids originally optimized by us at Dysonkyo. And we do plan to supply, start to supply within this year with the Omicron XBB strain monovalent vaccine by the end of this year. And I do want to mention here also that one of our unique features about our vaccine is that it can be stored at the refrigeration temperature and does not require freezing. Next slide. Okay, in terms of more progress on this next wave program, the van flight program, the quisartanib, the FLT3 ITD patients with the acute myelogenous leukemia, we have been recommended for approval by the European Union, by the CHMP in September. So we hope to receive official approval for van flight in the very near future. We also have a new program. This is, again, another ADC called DS3939. This is a DXC ADC directed against the antigen called MUC1. This is intended for solid tumors, and we initiated a phase one trial of this new program in September of 2020. And finally, we also initiated a phase one program with DS-1471. This is an anti-CD147 antibody. This is not a DXDA-DC, but just an antibody. And this is a new antibody against a new target. And of course, we're very interested in to see how this program turns out also. Next slide, please. Next slide, next slide again. I do want to mention to you a little bit more information about our R&D day for 2023, in which we will be focusing really on the range and breadth and depth of our R&D program, our pipeline, and that will take place in December, on December 11th, and it will be a virtual meeting. Next slide. In terms of the future news flow, I just want to very briefly go through what's likely to be reported between now and the end of the fiscal year 23, which is end of March 24. First, in terms of major publications, you can expect to hear The data from the Destiny Breast 08 trial. This is a new study, new data that you'll be hearing at San Antonio in patients who have HER2 low breast cancer, who are chemo-naive and post-op chemo. And this is a phase 1B clinical trial with various combinations of N-HER2 plus additional agents. later that month in December, also in December, at the American Society of Hematology, you'll see the primary analysis from the Valentine PTCL01 study. This is a study of our drug, is harmia, the dual EZH2 drug in patients with PTCL relapsor refractory. In terms of planned regulatory admissions, on the right you'll see We hope to be submitting a filing for both Destiny Lung 05, which is the HER2-mutated non-small cell lung cancer in the second line plus, and also Destiny Gastric 06 HER2-positive gastric cancer in the third line setting, both for China in sometime in the first half of, excuse me, second half of fiscal year 23. In terms of regulatory decisions, we expect to have a regulatory decision made by the European Union for the quantum-first AML trial for the PlanFlight program, and also the COVID vaccine from the PMDA sometime between now and the end of fiscal year 23. And finally, in terms of key data readouts, we do expect to be seeing data from Destiny Breast 06 clinical trial. This is a large randomized phase three trial who are in patients who are chemo-naive and who have hormone receptor positive and HER2 low and breast cancer. And this patient population also includes not just the HER2 low, but the ultra low. So this is a very important clinical trial for us. Next slide. Okay, so this completes my presentation, and I turn this over to Asakura-san.