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 three . 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 four. This slide shows an overview of consolidated financial results for Q2. Revenue increased by JPY 118.5 billion, or 19.5% year-on-year to JPY 726.3 billion.
Cost of sales increased by JPY 29 billion. SG&A expenses increased by JPY 66.9 billion. R&D expenses increased by JPY 12.2 billion, all compared to the same period last year. As a result, core operating profit increased by JPY 10.5 billion or 12.4% year-on-year to JPY 95.3 billion. Operating profit, including temporary income and expenses, was JPY 95.1 billion. That is the same level as the same period last year. The profit attributable to the parent company is increased by JPY 38.7 billion or 66.4% year-on-year to JPY 97 billion. As for the exchange rate performance, $1 was JPY 141. It's a 1 JPY depreciation of JPY 7.02 year-on-year, and one euro was JPY 153.38 .
That's a 1 JPY depreciation of 14.66 JPY year-on-year. Please see slide five. From here, I will explain the factors behind the change compared to the same period last year. Revenue increased by JPY 118.5 billion year-on-year. I will explain the breakdown by business unit. First, Japan business. Direct oral anticoagulant Lixiana, anti-malignant tumor agent ENHERTU , pain treatment drug Tarlige, and increased sales of Daiichi Sankyo Healthcare drove a revenue increase by JPY 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 VANFLYTA in the U.S. pushed up the revenue by JPY 70.7 billion.
As for American Regent, although sales of iron deficiency anemia treatment Venofer increased, a decline in sales of Injectafer, an iron deficiency anemia treatment, and other factors led to a revenue decrease by JPY 300 million. As for EU specialty business, due to growth in sales of Lixiana and hypercholesterolemia treatment Nilemdo and Nustendi, revenue increased by JPY 6.3 billion. As for ASCA business in charge of Asia and Latin America, due to growth in ENHERTU , mainly in Brazil, revenue increased by JPY 11 billion. ENHERTU and Dato-DXd upfront and quick 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 JPY 13.4 billion.
The overall impact of foreign exchange on revenue was JPY 25.5 billion. Slide six shows the factors contributing to changes to core operating profit. I will explain the JPY 10.5 billion increase in profit by item. As I explained earlier, revenue, including an increase of JPY 25.5 billion due to the impact of exchange rates, increased by JPY 118.5 billion. 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 JPY 22.9 billion. SG&A expenses increased due to an increase in profit share with AstraZeneca related to ENHERTU by JPY 56.8 billion. R&D expenses increased due to an increased R&D investment in five DXd ADCs by JPY 5.7 billion.
The total cost increase due to exchange rate impact was JPY 22.7 billion. The actual increase in core operating profit, excluding foreign exchange impact, was JPY 7.7 billion. Slide seven shows the increase and decrease in profit. Core operating profit was, as was explained earlier, increased by JPY 10.5 billion, 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 JPY 11 billion 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 JPY 11.4 billion year-on-year.
Regarding corporate income tax, et cetera, 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 Espha, contributed to the decrease by JPY 27.9 billion year-on-year. As a result, profit attributable to the owners of the company was JPY 97 billion, an increase by JPY 38.7 billion year-on-year. Slide eight and nine show changes in the revenues of business units and major products in Japan on a JPY basis, whereas Slide five showed the situation of each unit, excluding the impact of foreign 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. Merck for HER3-DXd, DS-7300 and DS-6000, which was recently concluded on October twentieth. Please see slide 11.
Daiichi Sankyo and U.S. Merck will co-develop and co-commercialize HER3-DXd, DS-7300 and DS-6000 worldwide, excluding Japan. By collaborating with U.S. Merck, 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 five DXd ADCs, post-DXd ADC modalities, and et cetera. Mono and combination therapy for the three products will be co-developed, and U.S. Merck 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 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 Merck. 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 $22 billion, or JPY 3.3 trillion, at exchange rate of JPY 150 to the $1 . The upfront payment is $1.5 billion for each of three products, for a total of $4.5 billion or JPY 675 billion. The timing and amount of 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 DS-7300 of $500 million each, for a total of $1 billion or JPY 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 or JPY 2.475 trillion. The sales milestone for each of the three product is up to JPY 5.5 billion, 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. Merck will bear 75%, and we will bear 25% of the development expenses, up to $2 billion per product. In other words, U.S. Merck will pay $500 million more than when expenses are split evenly. Development expenses exceeding $2 billion will be split equally between the two companies, as shown in the upper part of the figure. The method of payment of the $500 million borne by U.S. Merck varies, depending on the product. First, regarding HER3-DXd and DS-7300, 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 DS-6000. 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 Regent, while factoring in the Forex impact of the weaker yen, sales expansion mainly by ENHERTU , and deferred revenue from the upfront payment associated with the strategic alliance with US Merck for three DXd ADCs. The forecast is revised upward by JPY 100 billion from the April forecast to JPY 1.55 trillion. While cost of sales is expected to increase due to Forex impact, it's expected to increase only by JPY 10 billion 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 JPY 60 billion, considering the increase due to Forex impact and the increase in profit sharing with AstraZeneca following ENHERTU sales growth.
R&D expenses are expected to increase by JPY 15 billion, including an increase due to Forex impact and an increase due to accelerated development of DXdADC product lines, and a decrease due to the commencement of cost sharing with U.S. Merck for the three DXdADC products. As a result, core operating profit and operating profit are revised upward by JPY 15 billion to JPY 155 billion and JPY 150 billion, respectively. Profit before taxes is revised upward by JPY 25 billion to JPY 160 billion, taking into account an improvement in the financial account balance due to rising interest rates in the U.S., et cetera. The current profit attributable to the owners of the company is revised upward by JPY 20 billion to JPY 135 billion, reflecting the upward revision of the profit before taxes.
The exchange rate assumptions for the third quarter and beyond are JPY 145 to the $1 and JPY 155 to the euro, and the Forex impact of the yen's depreciation versus the April forecast is expected to be about a JPY 80 billion increase in revenue and a JPY 6 billion increase in core operating profit. Slide 16 shows the revised annual dividend forecast. We will increase our annual dividend forecast for FY 2023 from JPY 34 to JPY 40 per share. At the time of the April 2023 announcement, the annual dividend was planned to be JPY 34 per share, an increase of JPY 4 per share over the actual dividend for FY 2022, based on the increased likelihood of achieving the KPIs for FY2025 by the expansion of sales of ENHERTU and other factors.
In October 2023, following the conclusion of strategic alliance agreement with U.S. Merck for the three DXd ADC products, Daiichi Sankyo will receive an upfront payment upon signing the agreement. Due to the strong performance of ENHERTU and other products, the consolidated financial forecast will be revised upward. The dividend will be revised to 40 JPY per share, an increase of 6 JPY per share compared to the April announcement, and an increase of 10 JPY per share compared to the actual dividend for FY 2022. We will continue to improve capital efficiency and further enhancement shareholder returns, aiming to achieve a DOE of 8% or higher in FY2025, which is a KPI of the fifth midterm plan. Next, I'd like to discuss our business update. Slide 18 shows a breakdown of ENHERTU's revenue.
Product sales for the FY 2023 Q2 year-to-date increased by JPY 93.9 billion year-on-year to JPY 173.4 billion, 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 FY 2023 Q2 year-to-date decreased by JPY 12.7 billion year-on-year to JPY 4.2 billion, 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, ENHERTU total revenue, including upfront and milestone-related payments and the regulatory and sales milestones for the FY 2023 Q2 year-to-date, was JPY 183 billion, an increase of JPY 81.2 billion year-on-year.
The full year forecast for FY 2023 has been revised from the forecast announced in April to JPY 433.6 billion, an increase of JPY 65 billion from the forecast announced in April due to strong sales. Using the two slides starting on slide 19, I will discuss the sales of ENHERTU 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 FY 2023 Q2 year-to-date totaled JPY 105.9 billion, or $751 million, an increase of JPY 50.5 billion year-on-year. The full year forecast for FY 2023 has been revised from the forecast announced in April to JPY 229.5 billion, an increase of JPY 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 pre-treated HER2- low expressing breast cancer also holds the top position, with new patient share in the mid-50% range. ENHERTU 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 JPY 39.2 billion, or $278 million, an increase of JPY 25.6 billion year-on-year.
The full-year forecast for FY 2023 has been revised from the forecast announced in April to JPY 92.8 billion, an increase of JPY 17 billion 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% in the mid-50% range, respectively. In the U.K., the new patient share expanded to approximately 50%, achieving a top position. The share of the post-chemo new patients with HER- 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 for this new indication. Slide 20 shows ENHERTU 's sales in Japan and the ASCA region. In Japan, results of the product sales for the FY 2023 Q2 year-to-date totaled JPY 10.4 billion, an increase of JPY 5.2 billion year-on-year. The full-year forecast for FY 2023 has been revised from the forecast announced in April to JPY 21.5 billion, an increase of JPY 1.6 billion 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. ENHERTU 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 FY 2023 Q2 year-to-date totaled JPY 17.9 billion, an increase of JPY 12.6 billion year-on-year.
The forecast for the full year of FY 2023 is JPY 37.8 billion, an increase of JPY 8.6 billion 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 ENHERTU 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 U.K., Spain, and other European countries. As a result, global revenue for the FY 2023 Q2 year-to-date was JPY 1 37.7 billion, an increase of JPY 20.4 billion year-on-year. For the full year of FY 2023, we expect the revenue to be JPY 277.3 billion, an increase of JPY 33.4 billion 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 JPY 57.1 billion, an increase of JPY 6.4 billion year-on-year. For the full year of FY 2023, we expect a revenue of JPY 112.9 billion, an increase of JPY 7.7 billion from the previous year. Slide 23 provides a major update on our patent dispute with Seagen 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 Daiichi Sankyo to pay Seagen the damages of $41.8 million, determined in the July 2022 judgment, plus an 8% royalty on ENHERTU sales in the United States from April 1, 2022 to November 4, 2024, when Seagen'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 Seagen'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 Next Wave program, as well as information about our research and development day and our news flow for the next few months, for until the end of the fiscal year 2023. 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 are familiar with.
Recently, we reported on the 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- PanTumor 02 and DESTINY- CRC 01 and 02. These two trials led to two breakthrough therapy designations from the FDA. It's very important to note here that these results reaffirm the potential of ENHERTU 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 PanTumor 02 clinical trial. We have listed here over half a dozen different cancer types and 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 a 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 IHC 3+ positive. We can also see additional good responses in IHC 2+ positive patients as well. Overall, in the ITT patient population, the response rate was 37.1%, with a median duration of response of 11.3 months. But that among the IHC 3+ patient population, the response rate was 61.3%, a median 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 ENHERTU 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 recommendation for approval in Europe by the CHMP in September. We did obtain, in fact, approval in Europe for this particular indication in October.
In terms of the DESTINY-PanTumor01 study in the HER2 mutant solid tumors, the data that just mentioned, that 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, TROPION-01. Overall, here we show you the overall efficacy in the 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 positive data, positive clinical trial, in which we are reporting on the PFS as part of our interim analysis.
You'll see here that in the ITT patient population, we can see positive data in terms of a statistical significance, with a P- value of 0.004, which is less than the pre-specified P value of 0.008. 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 analyses of progression-free survival in the key subgroups. I want to draw your attention, particularly to the at the bottom, where it says histology, the yeah, non-squamous versus squamous patient population.
What you'll see there is that in a 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 progression 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 was 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, with a hazard ratio of 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 in the Dato arm, and 3.7 months in the docetaxel control arm, with a hazard ratio of 0.63. And 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-squamous 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 in, based on the data shown here. In contrast, on the right-hand side, you'll see the data for the squamous type, non-small cell 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 going, ongoing with the regulatory agencies towards a 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-Lung08. This is a frontline clinical trial in which Dato-DXd is being studied. And 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 a non-squamous patient population. Next slide.
I do want to mention here that the safety data that we are seeing in the TROPION-Lung01 study, in terms of all grades of safety and adverse events, grade 3, but with a focus on what we call adverse events of 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 DXd ADCs, and you'll see the numbers listed there. The ocular events and some of the stomatitises are very manageable toxicities with various prophylaxis and also a treatment of the emerging toxicities. In terms of the ILD, the numbers are listed here in terms of all grades and grade 3 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 7 adjudicated drug-related grade 5 events falls out in terms of four out of 232 patients, or 1.7% for the non-squamous, versus three out of 65 patients for four-- 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, when classified according to the histology, non-squamous versus squamous. Next slide. We're going to switch over to a different study called TROPION-Lung05.
This is a clinical trial, a Phase II clinical trial, in which data was studied as a single agent in patients with heavily pretreated non-squamous lung cancer, non-small cell lung cancer patient population with AGAs. This clinical trial enrolled only patient with AGA type of non-small cell lung cancer. You'll see here that in this Lung 05 study, there's good response rate in the 30s with a very good duration of response. This data here, this is a single-arm Phase II trial. This complements the data that we are seeing in a TL 01, in the AGA patient population that we saw in the TL 01 study. Next slide.
Finally, in terms of the lung cancer program for the Dato, the last clinical trial I want to mention here is TROPION-Lung04. These are data from an interim analysis in which Dato combined with various types of chemotherapy as a doublet or with a triplet is being studied in a 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 as a triplet combination in the cohort 4. And you'll see that, however, the response rates are quite high, 50% in the cohort 2 as a doublet, and a response rate of 76.9% as a triplet.
We also see a very good durability of response in terms of progression-free survival so far. These are the basis for our initiation of the clinical trials in the frontline setting, the TL07 and TL08 that I mentioned to you earlier. Next slide. Finally, for the Dato program, I want to mention to you the TROPION-Breast01 clinical trial. This is a randomized Phase III clinical trial, in which Dato was studied in patients with hormone receptor-positive, HER2- low or negative breast cancers. You'll see here are 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. 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 experimental arm with Dato, and 4.9 months in the investigator choice control arm. A hazard ratio of 0.63, these are really very good numbers. And of course, we are, 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. This is what we're seeing here is just arm 7 of the Begonia trial, in which the combination of durvalumab and DXd and Dato-DXd is being evaluated in patients with front-line advanced metastatic triple-negative breast cancer.
Here, you'll see that this combination, the two-drug combination of Dato-DXd plus durvalumab, gave a response rate of 79%, and the median PFS was 13.8 months. These are really very meaningful data when we consider that in the current standard in which pembrolizumab was studied in KEYNOTE-355 study, the median PFS, in that study, was reported to be 9.7 months. So these are really we think that these are very meaningful data and really demonstrates the value, potential value of Dato-DXd and durvalumab in the setting of triple negative breast cancer. Next slide. Finally, we're gonna touch on the remaining of the DXd ADCs. First, the HER3-DXd ADC program. Here I show you the data from a pivotal registration study, HERTHENA-Lung01 study.
This is a phase II single arm study, in which HER3-DXd was studied as a single agent in patients with multiply relapsed EGFR mutated non-small cell lung cancer. Here you'll see response rates that reported to be 29.8%, median duration of 6.4 months, PFS of 5.5 months. You can see that efficacy was observed in across a diverse mechanism of EGFR TKI resistance. 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 DS-7300 program.
This is a DXd ADC directed against the antigen called B7-H3. You'll see here, we are starting to show a lot of efficacy of this, DXd 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, but already you can see activity of DS-7300 in all these four different types of cancer indications. 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, a multiply relapsed 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 DS-6000 program. This is a DXd ADC directed against an antigen called CDH6, which is abbreviation for cadherin six. 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.
Despite that, we see a response response rate of 46%, and 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 DS-6000 in ovarian cancer. In these three ADCs that which I just mentioned to you, the HER3 program, the DS-7300 program, and DS-6000 program. All of these three ADCs have additional cancer indications to explore beyond the ones 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's 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, now for the, 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 DXd ADCs that, 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 XBB. 1.5 strain, for COVID. So I do wanna 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 Daiichi Sankyo. 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.
I do wanna mention here also that one of our unique feature 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 VANFLYTA program, the quizartinib, the FLT3-ITD patients with acute myelogenous leukemia. We have been recommended for approval by the European Union, by the CHMP in September, so we hope to receive the official approval for VANFLYTA in the very near future. We also have a new program, this is again another ADC called DS-3939. This is a DXd ADC directed against the antigen called MUC1. This is intended for solid tumors, and we initiated a phase I trial of this new program in September of 2023.
And finally, we also initiated a phase I program with a DS-1471. This is an anti-CD147 antibody. This is not a DXd ADC, but just an antibody, and this is a new antibody, a new, against a new target. And of course, we're very interested in to see how this program turns out also. Next, next slide, please. Next slide, next slide again. I do want to mention to you a little bit of 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 11, and it will be a virtual meeting. Next slide.
In terms of the future news flow, I just want to very briefly go over with you what's likely to be reported in between now and the end of the fiscal year 2023, which is end of March 2024. First, in terms of major publications, you can expect to hear the data from the DESTINY-Breast08 trial. This is a new study or new data that you'll be hearing at the San Antonio in patients who have HER2-low breast cancer, who are chemo-naive and post or chemo. This is a phase Ib clinical trial with various combinations of ENHERTU plus additional agent.
Later that month, in December, also in December, at the American Society of Hematology, you'll see the primary analysis from the valemetostat PTCL-01 study. This is a study of our drug valemetostat, the dual EZH2 drug in patients with relapsed or refractory PTCL. In terms of planned regulatory submissions, on the right you'll see we hope to be submitting a filing for both DESTINY-Lung05, which is the HER2-mutated non-small cell lung cancer in the second-line plus, and also DESTINY-Gastric06, HER2-positive gastric cancer in the third-line setting, both for China in sometime in the first half of, excuse me, second half of the fiscal year 2023.
In terms of regulatory decisions, we expect to have a regulatory decision made by the European Union for QuANTUM-First, for the QuANTUM-First AML trial for the VANFLYTA program, and also the COVID vaccine from our PMDA, sometime between now and the end of the fiscal year 2023. Finally, in terms of key data readouts, we do expect to be seeing data from DESTINY-Breast06 clinical trial. This is a large, randomized, Phase III trial in patients who are chemo-naive and who have hormone receptor-positive and HER2-low breast cancer. 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 then this completes my presentation, and I turn this over to Asakura-san.
Now we would like to start taking questions from the audience. The first question comes from UBS Securities, Haruta-san. Please go ahead.
I am Haruta from UBS. My first question is, and this is looking at only Q2, cost of sales improved for Q2. As ENHERTU sales proportion goes up, cost of sales is going to improve further, I think, having a bigger contribution coming from ENHERTU . And I would like to ask you, to what extent this could further improve? For ADC production, you are using outside CMOs. And what about the investment level there, and what about the efficiency of CMO producing this drug for you?
Thank you for your question about the cost of sales ratio. Basically, ENHERTU is contributing to the improvement of the cost of sales. As ENHERTU sales is going to go up, which means a better product mix, meaning that cost of sales is going to come down in terms of the ratio to a certain extent in the midterm. In terms of the supply of this product, in April of this year, we already made an announcement that we will have sufficient supply capacity for ADCs to be prepared. We have in-house facilities as well as the external CMO facilities being sort of upgraded with further CapEx investment. Therefore, we will be able to secure enough supply capacity going forward. That's what we believe.
Thank you very much. So I think cost of sales is going to come down even further, or there is further room for improvement of cost of sales. Is that right?
Yes, that is right.
Thank you. I have a second question. In the ESMO highlight, I think nobody asked this question so much, but this is about DS-6000 potential. I would like to learn more about that. Right now, ovarian cancer is the targeted indication, and in this indication, the folate receptor targeting ADC is there in the competitive environment. And if DS-6000 is going to get more market share in the market, folate receptor targeting ADC can be one of your benchmarks. Cadherin-6 potential against the folate receptor targeting ADC, what is the potential of your compound vis-a-vis the competition?
You know, ultimately, it's a data-driven decision in terms of how physicians view DS-6000 versus, for example, the folate receptor-targeting drugs. You know, right now, we are fairly early in our program, but I think I do want to mention here that right now, we do see activity that seems to be at least as good as, if not better than, other drugs that are the other recent drugs, like the folate receptor-targeting ADCs that have been reported for ovarian cancer. I do want to mention, for example, that so far we do, we do see a lot of activity of DS-6000, regardless of the expression of the CDH6. So, that may be an advantage as for our DS-6000 program.
But ultimately, I have to say that it really requires us to generate clinical data to be absolutely sure of how our physicians may use DS-6000 versus other drugs available in the setting.
Thank you very much. Understood. Next question is from Yamaguchi-san, from Citig roup.
This is Yamaguchi from Citi. Can you hear me?
Yes.
Thank you. My first question is about the share buyback. I believe this is a repeatedly asked question. You're having a very good performance with upward revision of the performance, and there is an increase of the dividend being announced. However, the stock price is not that high right now, and I think this is really a good timing to talk about the share buyback. Are you thinking about this as an option? Right now, it's not happening yet, but is it still an option? This is my first question.
Yes, thank you very much for your question about the share buyback. As we have been mentioning in the past already, we included in the return to the shareholder policy in the fifth midterm plan. We believe this is an effective way of returning the value to shareholders, and we always consider how possible it is that we can realize that all the time... So when the legal conditions are met, we'd like to consider share buyback with an agile manner, so that we can give a better return to the shareholders.
Thank you very much for your answer. My second question is about filing of HER3-DXd. You received the breakthrough designation, so you can already go ahead with the filing, I believe. But I, I think it really depends upon the position of FDA. And so how is the filing situation of HER3-DXd right now?
Yes, we are proceeding to file the data with the regular agencies, and, you know, I don't really anticipate major issues at the moment. But we'll have to see exactly what the FDA says. And so once we have submitted the information, the file to the agencies, we will certainly let you know.
Second question regarding this one is that you didn't write the TROPION or Dato-DXd filing into your news flow for the second half. Is that meaning it's not in the second half, or you really don't know at the moment regarding Dato-DXd filing timing? I see ENHERTU China, and I see HER3-DXd, but I don't see Dato-DXd here. What's your opinion?
I think that's probably an oversight, that because we do plan to submit the TL-01 data.
I mean, within this fiscal year?
We haven't announced exactly when we will file.
Okay, that's why you didn't put it in, but, that's right. Thank you. And finally, regarding TROPION-Breast and TROPION-Lung, which comes first? TROPION-Lung comes first for filing, or breast comes first?
You know, that's a very interesting and very important question that really relates to regulatory strategy, and I don't think we have actually announced the sequence of how we will file either. But it's a very important question, of course.
Thank you.
Now, nex t question is from Goldman Sachs, Ueda-san.
I am Ueda from Goldman Sachs. My first question is about Dato-DXd TROPION-Lung08 study. You mentioned the design of the study is going to be modified. Squamous cell lung cancer patients' enrollment is going to be stopped. So going forward, whether the primary endpoint is going to be met or not, is that going to be analyzed upon the basis of PFS only for known squamous lung cancer patients? Or are you going to be analyzing all of the patients who have been enrolled so far?
So we haven't announced the details of this amendment. So I can only tell you that, you know, we're gonna restrict the number of patients who have a squamous type, and that really our major focus of the clinical trial and really the filing, ultimately, is gonna be in the non-squamous patient population. Once we're ready to announce the details of the amendment, we can certainly let you know about that.
Thank you very much. My second question is about the TROPION-Lung01 study, and it's about the endpoint of the study. It says it's a dual primary endpoint. That is how it is described here. Is this a core primary endpoint, which means you have to evaluate all of the items in the composite endpoint, or is this a multi-primary endpoint, where if you can confirm just one out of the items, it's considered a success?
Has dual endpoint, as you mentioned, right, and at the recent ESMO meeting, we reported on the first interim analysis for efficacy, which is a focus on progression-free survival. There will be a final analysis that really focuses on overall survival. So both of these are designed to be primary endpoints. So that's why these are really dual endpoints. Positive data, technically, the positive data with either one of these endpoints is considered to result in a positive study. But of course, ultimately, it's not just the endpoint, but also really the what is the clinical data look like. So these are very important points that we'll be discussing with the regulatory agencies.
Thank you very much. That's all from me. Thank you.
Next question is from Morgan Stanley MUFG, Muraoka-san. Please go ahead.
Good evening. I am Muraoka from Morgan Stanley. Very nice to meet you. I'm sorry, I may be repeating the same question, but this is again about the share buyback. The stock price is as it is, and of course, it depends upon the external environment. But shareholders who are owning your stock for a long time may be facing a quite difficult time. So the reason why you didn't buy back your share, although you have raised your dividend, it is because of the legal conditions, as you have mentioned. But what do you mean by that? The legal framework or the legal conditions have not been met at this timing?
Or even if those legal conditions are met, it's not a good timing for you to have share buyback. And I'm asking you this question because I do want you to support the share price.
Thank you for your question. About share buyback, the assumption is that the legal environment should be met, and this is one of the policy for the return to the shareholders in the midterm plan. So it really depends upon the situation. We always have this as one of the options.
I'm sorry, I'm being very persistent, but the legal situation did not allow you to have share buyback this time. We are not disclosing the details. I'm sorry. Understood. Thank you very much. Now, next question. On slide 15, and this is about the revision of the guidance. I have not fully understood the figures myself yet. I'm sorry.
But the Merck, the deferred revenue, is included in here. But still, the increase of only this level for the core operating profit, because Merck, the deferred revenue alone can boost the profit by about JPY 15 billion for half a year, right? But excluding that, the profit is barely increased. Is it offset by SG&A expenses?
In relation to the collaboration with Merck, as you have just pointed out, one thing is the upfront payment of about JPY 10 billion in size, and this is received upon contract execution, and that is included as a top line. And another thing is an R&D expense, upfront payment, and how this is going to be booked accounting-wise, this has not been completely decided yet. So as to the financial forecast, R&D expenses have been reduced by about JPY 10 billion, and this is already being factored in. So these two factors have already been reflected in this forecast.
Thank you very much for your explanation. An increase of JPY 60 billion to the SG&A, I am afraid that is too much, even considering your payment to AstraZeneca. The stock price-linked compensation that was quite popular in the U.S. is not a factor, I believe, so it's not really convincing. So can you please elaborate it more in detail, this increase of JPY 60 billion in SG&A?
Okuzawa-san, please. I can't hear Okuzawa.
Yes, I'm sorry. So about the increase of SG&A, and this is due to the foreign exchange. We have about JPY 45 billion, and that is the impact factored in. And the payment of the profit share is also reflected in here. In addition, ENHERTU indication expansion and geographical expansion of ENHERTU , cost associated to that is also included in here.
Thank you very much.
Next, from JP Morgan, Wakao-san, please. Go ahead.
I'm Wakao from JP Morgan. TROPION-Lung01, I have some questions about the timing of OS. According to clinicaltrials.gov, primary endpoint or completion was supposed to be January of 2024, according to the site, but it depends on the event occurring. So what is the timing of OS data announcement? Is it going to be expected around February to March of next year? So please, make a comment on the timing of OS data coming out.
Yes, the timing, the OS data analysis is really event-driven, as you mentioned. And, at the moment, it's difficult to predict exactly when that will be. So we cannot say it's gonna be January or February or March. So I think you just have to wait for the events to happen, just like the rest of us, really.
Thank you. The second question. Takeshita-san, without, even without the AGA actionable gene, non-squamous hazard ratio was 0.7, which is meaningful. I think Takeshita-san said that. So based on this, in your mind, Takeshita-san, about the first line from these results, I don't think it's changed? Or because of the data accumulated more, therefore, you are probably improving the confidence for the first line. So any change in the impression based on this data? About the first-line therapy, how do you see this right now?
The zero one data is very informative, in terms of how we think about the front-line study, because we know now that much of the efficacy data is concentrated in the non-squamous patient, patient population. By focusing on the non-squamous patient population for our front-line clinical trials, we believe that, we have reduced the risk by focusing on what we think is the most, the patient population that benefits the most from the drug.
Thank you very much. My last question. TROP2 ADC, especially EGFR mutated patients, AGA, it works very well, from your own data as well as the data from Merck. I would like to understand the mechanism more. Therefore, if you know, please let me know. As for the results of TL-01, TROP2 expression and the AGA, with or without, was there any correlation between the two? If you do not have the data suggestive of that, when would you be able to obtain such data in the form of presentation or paper?
A very interesting question about what we know about the mechanism of why there is particularly notable the efficacy in the AGA patient population, and right now, we don't have an answer to that question. It's a very interesting question from a biology standpoint. It's not clear to us that whether it's related to TROP2 level, the expression, at least if you look at the standard IHC assays, which is that's what we have done so far. So we just have to do some more digging to understand what is the molecular basis for the activity of at least the Dato-DXd in the AGA patient population.
Thank you very much. Well understood.
Next question is from Hashiguchi-san of Daiwa Securities, please.
I am Hashiguchi. Thank you. I have two questions in relation to the development. The first question is about Dato-DXd for NSCLC and combined with the immunotherapy in the past phase 1 study result. I would like to ask a question. And in this study, or this or have been already presented at their conferences, and for the squamous versus non-squamous cells, and maybe this is the first time you split the non-squamous versus squamous to announce. And this zero eight study, the design will be modified, and in the first line, combination with immunotherapy, phase 1 study, and in the non-squamous cell carcinoma had a higher efficacy than the non-squamous cell the the carcinoma. So based on that kind of difference, you have decided to make this change.
The TL-04 clinical trial data. The question really is, have we done the subgroup analysis of patients who are non-squamous versus patients who are squamous? We haven't reported that yet, so you'll have to... So please, I hope you please wait until we have that reported so that we can answer that question for you.
Thank you. The second question is about the presentation scheduled in San Antonio of breast cancer. And you are going to announce the part of the cohort of this study, and endocrine therapy-sensitive patient will be the target. And then combination with the, there is a cohort of combination with the the therapy and and HER2-low HER2-low patient, and this the hormonal therapy the sensitive patient. And what do you- what is your idea of the possibility of developing drug further for or such a patient?
So, yes, we at the San Antonio Breast Cancer Conference, there is a plan to show clinical data from this Phase 1b study. These are combination study that you mentioned. Now, I don't think we have actually said anything about which cohorts we are going to be reporting at the San Antonio. So I hope that you can wait until we have that information, and then we can talk about what is our strategy going to be based on the data in that particular cohort.
Thank you. Thank you very much. This is it.
Next question. Mitsubishi UFJ Trust Banking Corporation, Hyogo-san, please.
I am Hyogo, I'm the fund manager from Mitsubishi UFJ Trust Banking Corporation. Thank you for your detailed explanation. I truly appreciate it. About the share buyback, once again, I'd like to ask you some questions. There are some sell- side people who are interested in that as well. So DOE 8% or higher, and this goes above the capital cost, that's 8%. And after Dato- DXd data announcement, the share is very volatile, and I think the cost of capital is actually going up. So against this backdrop, I think a share buyback is one way to. And of course, canceling that, how much ROE is going to go back?
But then I think, share buyback is one way to reduce the volatility of the share price. And the cost of capital, it's not very clear. DOE 8%, that is, the focus. But if you, that is the only focus, it is as if you are not really putting the top priority on share buybacks. So could you comment on that?
Thank you very much for your question. So as a company, cost of capital is something that we are very much aware of, very much we are conscious of in our management in the fifth midterm management plan. This is about the discipline of finance. Right now, it's 6%. As you have pointed out, beta value goes up and down, and this is affected by beta value to a certain extent.
But in any case, it's around 6%, and this is something that we are very much conscious of. And as a KPI of shareholder return, DOE of 8% or higher by 2025, and ROE of 16% or higher, these are very important targets, and as the management, we are committing to these target numbers. Therefore, it's not as if, as you have pointed out, the share buyback is underestimated. It's not the case, because we think that a share buyback is a very important, effective manner to return to shareholders. Therefore, we always have it in mind as one of the options.
Thank you very much for that. Beta value is one, but also the long-term interest rate is going up. Therefore, if, well, you have very good pipeline, and if you do DCF, the target price always goes down. That's my idea. Therefore, DOE of 8%, when you meet that target, beta value, and because of the long-term interest rate going up, the expected return may not be realized for minority shareholders, which is not a good thing. And the deal with Merck, I think, transiently, probably, but this is going to really change the balance sheet because of the cash in. So, given all of these factors, please have internal discussion thoroughly. And, with the deal of AstraZeneca, I think the cost structure was not very clear either. ENHERTU revenue going up, but in terms of the costs, maybe I'm not really understanding it very well.
But then, oftentimes, the cost was not very clear, and then we often missed the actual performance, prediction. Therefore, please visualize it. Probably, this deal is different, and the deal is very well thought through, and the structure is very well, well thought through, and it's very interesting. But, please visualize the cost structure in order to avoid any, misleading, situation for the investors. So that's my suggestion in my humble position.
Thank you very much for your pointing out. The, interest rates going up in the U.S. and also the interest rates globally, we are always very conscious of those interest rates, and we're not trying to be closed in this country of Japan in terms of KPIs, and we do not always believe that our KPIs are right. So we really have flexibility so that we'll be able to give back to our shareholders in our management. In terms of the deal with Merck and then that is added on top of the deal with AstraZeneca. More than ever before, the cost structure needs to be clarified in our R&IR activities, as you have pointed out.
So we will continue to make efforts in that regard. The deal has just been concluded. Therefore, as of now, as I have already said, in terms of the impact of this Merck deal, we have the upfront deferred revenue booking, the top line, and also we have the refundable R&D upfront money being paid of around JPY 10 billion, plus or minus, and that's been reflected on the earnings forecast.
And then, the development planning will start for the three ADC products. The people from the two companies are going to work on the details of the development of these three. What kind of development is going to be done, at what timing? Once that's decided, $2 billion R&D expenses, the benefit of us paying only 25% is going to be quantified in a detailed manner going forward. Therefore, I do hope that you will see our efforts going forward. Thank you very much.
Thank you.
So in terms of the loss, profit and loss, and of course, we have a lot of expectations for you. But still, the profit, the loss, that should be clarified in a better manner. Of course, we needed to endure a certain period. From the next fiscal year, if we'll be able to see that more clearly, that would be good. I'm sorry to have said everything I have said in my humble position. Thank you.
In the interest of time, next question will be the last question. Sogi-san from Sanford Bernstein, please.
Thank you. The first question is about R&D-related question to Takeshita-san. One, we please correct me if my our understanding is wrong, but we understand that the there was a the protocol amendment for TL01 the in the middle to to accept those patients who have the actionable genetic alteration. So which means that, you know, we can assume that, you know, that there was some enrichment for those population who are likely to receive, you know, better the the the benefit from, you know, the drug, especially toward the end of the study. Meaning that that can actually increase the the the probability of success for OS. So is it the right, you know, the understanding?
Yes, that's correct.
Great. Thank you very much.
And another question is about the financial question. In the presentation, yen depreciation has been mentioned, and due to yen depreciation, top line and core operating profit impact has been also shared in the presentation. And in our core operating profits, has a negative JPY 6 billion impact due to the yen depreciation. Why? I ask this because naturally there is an increase of the cost due to the yen depreciation. That's understandable. But normally with the increase of the revenue the impact would be small. Therefore, if you add everything, then impact will be rather positive rather than the negative. So can you please explain?
The impact of yen depreciation to the, especially the profit, the development cost overseas is really the major contributor. And of course, there are other costs incurred overseas. So these are actually plus and minus. So if that is translated into the operating profit, then impact is somewhat offset. So in terms of profit share, the similar, the same thing also app lies.
Understood. One last question. ENHERTU U.S. sales... In EU and in Japan, the growth rate wise, it's in good progress. But in the United States, it seems like it's slowing down a little. But actually, you really have a very quick ramp up. Therefore, is it within your expectation or do you still also feel that this is really slowing down?
Well, now, ENHERTU, in U.S., in the first quarter and second quarter, and based on the U.S. dollar, then it may look rather flat rather than growing. That's what you are talking about, I guess. Yes, it's true that HER2 in the United States had a very sharp growth initially, since last year, and HER2 positive second line and HER2- low, there have been indications we have acquired or approved, so that in line with that, we had a major growth. And, second line and HER2-low, and both of them are growing in terms of market share steadily, and, it's around, 50 or even more than 50% market share we have obtained. So it's smooth. And, there is, some seasonality here, I thought. Actually, there is, summer holidays and also the Independence Day holidays, and those may be giving some minor negative impact to this. But in the second line or HER2-low and further, we expect the growth of the sales.
Also in the WAC or the wholesale purchasing price is actually higher than we have originally expected. Therefore, including this, the whole year forecast will be the one there is increase by JPY 100 million to the JPY 6,105 million.
Thank you.
Still some of you are raising your hands, but I'm really sorry that this is the time to close this part of the question and answer session with investors and analysts. Investors and analysts, thank you very much for your attendance today. Thank you.