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Ogawa speaking. Thank you very much for joining Daiichi Sankyo's financial results presentation out of a very busy schedule today.
I'm going to explain our FY 2023 first quarter financial results we announced at 1 p.m. on Monday, July 31, Japan time based on our presentation materials. Please turn to Page 3. This is the agenda for today. We will cover FY 2023 first quarter consolidated financial results, business update and R&D update in that order. R&D update will be explained by Wataru Takasaki, Head of Japan R&D. We will entertain your questions at the end. Please turn to Page 4. This is an overview of FY 2023 first quarter consolidated results. Revenue increased by JPY 70.5 billion or 25.2% year-on-year to reach JPY 350.8 billion. Cost of sales increased by JPY 18.9 billion from the previous year. SG&A expenses rose by JPY 39.3 billion, and R&D expenditure increased by JPY 2.2 billion year-on-year. As a result, core operating profit increased by JPY 10.1 billion or 29.4% year-on-year to reach JPY 44.5 billion.
Operating profit, including temporary gains and losses, increased to JPY 44 billion, up JPY 9.7 billion or 28.1% year-on-year. Profit attributable to owners of the company increased by JPY 38.2 billion or 202.4% year-on-year to reach JPY 57 billion. As for the actual currency rates, the U.S. dollar was JPY 137.37. The yen depreciated by JPY 7.80 against the dollar year-on-year. The euro was JPY 149.46. The yen depreciated by JPY 11.36 against the euro. Please turn to Page 5. From here, let me explain positive and negative factors for revenue compared to the previous year. Revenue increased by JPY 70.5 billion year-on-year. I'd like to explain its breakdown by business unit.
First, in Japan business, revenue increased by JPY 2.2 billion, as sales increased for direct oral anticoagulant LIXIANA; pain treatment Tarlige; anticancer agent ENHERTU; antiplatelet agent, EFIENT; and Daiichi Sankyo Healthcare. Next, let me explain our overseas business units. ForEx impact is excluded here. In oncology business, revenue increased by JPY 39.1 billion due to the growth of ENHERTU in the United States and Europe. As for American region, sales decreased for iron deficiency anemia treatment Injectafer, but sales increased for iron deficiency anemia treatment Venofer. So American region revenue increased by JPY 0.8 billion. Revenue for EU Specialty business increased by JPY 1.2 billion as sales increased for LIXIANA and hypercholesteremia treatment, Nilemdo/Nustendi. In ASCA business, responsible for Asia, South and Central American regions, revenue rose by JPY 6.9 billion due to the growth of ENHERTU mainly in Brazil. ForEx impact increased our revenue by a total of JPY 11.5 billion. Page 6 shows positive and negative factors for core operating profit. Let me explain the profit increase of JPY 10.1 billion by item. As I explained earlier, revenue increased by JPY 70.5 billion, including the increase of JPY 11.5 billion due to ForEx impact. Next, I will explain cost of sales and expense items, excluding ForEx impact. Cost of sales increased by JPY 15.6 billion due to the revenue increase. SG&A expenses increased by JPY 34.1 billion due to an increase in ENHERTU-related profit sharing with AstraZeneca, et cetera. R&D expenditure remained flat year-on-year. Costs increased due to ForEx impact by a total of JPY 11.5 billion. Core operating profit increased by JPY 10 billion, excluding ForEx impact. Next, Page 7 shows positive and negative factors for profit attributable to owners of the company. As I explained earlier, core operating profit increased by JPY 10.1 billion including ForEx impact. Financial income expenses, et cetera, increased our profit by JPY 13 billion year-on-year due to improvement in ForEx gains and losses and investment securities, valuation gains losses as well as increase in interest income. Income taxes, et cetera, decreased by JPY 15.4 billion year-on-year. Pretax profit increased, but we booked tax expenses by using the simplified method in our quarterly account settlement. Also due to the impact of the tax effect accounting associated with the decision to transfer Daiichi Sankyo Espha, the first quarter income tax was minus JPY 4.9 billion. As a result, profit attributable to owners of the company increased by JPY 38.2 billion year-on-year to reach JPY 57 billion. Page 8 and 9 show revenue increase or decrease in Japanese yen by business unit and by major product in Japan. Earlier on Page 5, I explained the situation of each unit by excluding the ForEx impact. But here, we are showing the results, including the ForEx impact. Next, I would like to give a business update. Slide 11 shows the breakdown of ENHERTU revenue. In the first quarter of FY 2023, product sales increased by JPY 50.4 billion year-on-year to JPY 81.7 billion due to growth in the U.S., Europe and other regions. The sales situation in each country and region will be explained later. Regulatory milestone payment in the first quarter of fiscal 2023 was JPY 2.1 billion, down by JPY 1.3 billion year-on-year compared to the regulatory milestone of last year because the regulatory milestone of last year included the amount of some milestone payments, which covered the period since the contract was concluded until the achievement of milestones. As a result, ENHERTU revenue, including upfront payments, Quid-related payment and development and sales milestone payments increased by JPY 49.2 billion to JPY 86.6 billion in the first quarter of FY 2023. For the full year of FY 2023, we forecast the revenue to be at JPY 368.6 billion, an increase of JPY 110.2 billion year-on-year. No change from the April figures. From Slide 12, for two slides, the sales performance of ENHERTU in each country and region will be explained. First, situation in the U.S. and Europe. Sales in the U.S. were JPY 51.6 billion, up by JPY 31.5 billion or $375 million from the same period last year. The current indications are as shown below. Market shares for each indication are also favorable. The share of new patients with HER2 positive breast cancer in second line is about 50%, maintaining the top share. Post chemo breast cancer with HER2 low also showed a strong growth, maintaining its #1 position with a new patient share growing further to nearly 60%. HER2-positive gastric cancer in second line maintained its #1 position with about 50% of new patient share. HER2 mutant NSCLC second-line treatment kept its top position with approximately 60% new patient share. Europe also showed steady performance. Product sales in the first quarter of FY 2023 went up by JPY 11.1 billion to JPY 17.8 billion or $130 million. The new patient share in each marketed country region is also expanding steadily. The new patient share with HER2-positive breast cancer in second-line treatment is around 60% in France, in the upper 40% range in Germany and in the 50% in Spain, maintaining the top positions. In addition, in France and Germany, the share of new patients in post-chemo HER2 low breast cancer grew to the mid-40% range and the mid-30% range, respectively, achieving the top positions. As for the progress with the product launch in Italy in July, we have achieved launches in five major countries in Europe. Slide 13 shows the sales status of ENHERTU in Japan and ASCA region. In Japan, the product sales for first quarter FY 2023 were JPY 4.4 billion, up by JPY 1.9 billion year-on-year. The current indications are as shown here. The share of new patients in each indication is steadily increasing. And for the second-line treatment of HER2-positive breast cancer, it increased to the mid-30% range, capturing the top share. HER2 low post chemo also saw a steady uptake. The share of HER2-positive gastric cancer in the third line grew to the 60% level, solidifying its #1 position. The product sales of the first quarter in the ASCA region increased by JPY 5.8 billion year-on-year, standing at JPY 8.0 billion. The product sales in the ASCA region include revenues from co-promotion in Hong Kong and other markets by AstraZeneca. Sales in the region have been favorable with significant revenue growth, mainly in Brazil. As for other progress, the product was launched in China in June for the second-line treatment of HER2 positive breast cancer. And in July, it was approved for the treatment of breast cancer in HER2 low post-chemo and promotion activities have started. In China, as in the case in the United States and Europe, the product will be co-promoted with AstraZeneca, but AstraZeneca will recognize product sales, and we will record 50% of gross profit as co-promotion revenue. We will continue to work for further market penetration and expansion of the countries, regions and to obtain new indications so that we can deliver ENHERTU to as many patients as possible. In Slide 14, I will present our initiatives related to profit growth for current business and products in Japan. In October of 2019, we launched the anticancer agent, VANFLYTA, for the indication of relapsed or refractory FLT3-ITD mutation positive acute myeloid leukemia, or AML. And in May this year, we obtained partial change approval for the AML first-line therapy for untreated patients in addition to the relapsed or refractory patients. In May, we also launched OD tablets, a new formulation of the pain treatment TARLIGE, which has been marketed since 2019. We will further enhance our contribution to patients by strengthening our product portfolio. As part of our transformation into a profit structure focused on patented drugs, we concluded a stock transfer agreement with Daiichi Sankyo Espha Co., Ltd. in May. Transferee is Qol Holdings. The transfer price is JPY 25 billion. 30% of the shares held by the company will be transferred on October 1, 2023. And then on April 1, 2024, 21% will be transferred. The execution date of the share transfer of the remaining 49% will be determined through separate discussions. I now hand over to Mr. Takasaki, General Manager of R&D Division, who will give you an update on R&D.
Takasaki speaking. I am going to talk about R&D update. First, an update on 5DXd-ADCs. Page 17 shows our R&D strategy. Due to higher potential of DS-7300 and DS-6000 as a growth driver candidates, following 3ADCs, we have changed our R&D strategy from [ 3 and Alpha ] to 5DXd-ADCs and Next Wave since April 2023. We plan to actively spend R&D expenditure also for promising pipelines in addition to 3ADCs to promote sustainable growth. From the next slide, I will explain the progress of the 5DXd-ADCs. Please turn to Page 18. Regarding ENHERTU, we have built evidence, first, in breast cancer and expanded indications to various other tumor types as well. This page shows the results of Phase II DESTINY-CRC02 study in HER2-positive metastatic CRC, which we presented at ASCO this year. In this study, we evaluated two doses, 5.4 milligram per kilo and 6.4 milligram per kilo. Promising efficacy was confirmed with ORR of 37.8% with 5.4 milligram per kilo and 27.5% with 6.4 milligram per kilo. Safety was comparable to the non profile. There was no ILD case of Grade 3 or above in the 5.4 milligram per kilo arm. The efficacy and safety profile of both cohorts favors the 5.4 milligram per kilo dose, so 5.4 milligram per kilo was selected as the optimal dose. Also, antitumor activity was observed in patients with and without RAS mutation at the 5.4 milligram per kilo dose. Please turn to Page 19. Let me explain the interim analysis results of another ENHERTU study, DESTINY-PanTumor02 in HER2 expressing solid tumors. We presented the results at ASCO this year. ENHERTU was studied in advanced solid tumors in the second-line settings and beyond where HER2-directed therapies are not yet available, such as cervical, endometrial, ovarian and biliary tract cancer. ORR, our primary endpoint, was 37.1% in all patients and 61.3% in patients with IHC 3+. Clinically meaningful activity was confirmed in both groups. Efficacy was sustained with median DOR of 11.8 months in all patients and 22.1 months in patients with IHC 3+. Safety was comparable to the known profile. As for ILD, one Grade 3 event and one Grade 5 event were observed, but the rest were Grades 1 or 2.
As is shown on Page 20, top line results from the primary analysis of DESTINY-PanTumor02 study were obtained in July 2023. Like the interim analysis, ENHERTU continued to show durable responses for ORR and DOR. For both PFS and OS and secondary endpoints, clinically meaningful results were demonstrated. No new safety signals were identified. All grade ILD was generally consistent with prior clinical trials. The details of the data will be presented at an upcoming Academic Society meeting. Based on this data, discussions with health authorities are ongoing. On Page 21, I will explain the progress of Dato-DXd. TROPION-Lung02 is a Phase Ib study to evaluate the doublet combination of Dato-DXd and pembrolizumab and the triplet with additional platinum chemotherapy in NSCLC patients in the first-line settings as well as the second-line settings and beyond.
At ASCO this year, we presented the data shown on this page. ORR in all patients was 38% in the doublet arm and 49% in the triplet arm. In the first-line patients, the doublet and the triplet arms demonstrated encouraging antitumor activity of 50% and 57%, respectively. On the other hand, as of now, the incidence of ILD was higher than Dato-DXd's other studies. But most of the events were predominantly Grade 1 or 2. Currently, no new safety signals were identified. And the trend of the adverse events was comparable to the non safety profile of Dato-DXd. But the efficacy and safety data is still preliminary, so we will continue to implement the study carefully and accumulate the data. Next, on Page 22. I will explain the progress of TROPION-Lung01 study. This is a Phase III study to evaluate the efficacy and safety of Dato-DXd compared to Docetaxel, the current standard of care in about 600 previously treated advanced or metastatic NSCLC second-line or third-line patients with or without actionable genomic alteration. We disclosed primary endpoint PFS final analysis data and OS interim analysis data in July this year. Dato-DXd arm demonstrated statistically significant improvement in PFS compared to the Docetaxel arm. As for OS, the other primary endpoint, the Dato-DXd arm demonstrated the trend of an initial improvement compared to the Docetaxel arm, but did not show a statistically significant improvement in the interim analysis. We will continue to implement the study and evaluate OS in the final analysis. In this study, no new safety signals were identified. The trend was similar to the results of other Dato studies. Grade 5 ILD events were observed, but the majority of the reported ILD events were Grades 1 or 2, generally consistent with prior clinical studies. Right now, we are sharing the detailed data with regulatory authorities and proceeding to file.
Slide 23 shows the progress of the HERTHENA-Lung01 study for HER3-DXd. At the FY 2022 Q4 earnings call, we reported that the HER3-DXd 5.6 milligrams per kilogram arm showed efficacy in patients with metastatic or locally advanced EGFR-mutated NSCLC, and that no new safety concerns were identified. Details of this data will be reported at the September WCLC. We are preparing for a regulatory submission in the United States in the second half of this fiscal year. In HER3-DXd, Phase III HERTHENA-Lung02 study for the second line treatment of NSCLC with EGFR mutations and the Phase Ib study evaluating the efficacy of HER3-DXd in combination with Osimertinib are ongoing. Slide 24 provides other progresses on 5DXd-ADCs. First of all, ENHERTU, in June, we initiated a combination study with DS-1103, an anti-SIRP-alpha antibody. Also, this month, based on data from the DESTINY-Breast04 trial, the drug was approved in China for the treatment of breast cancer with low HER2 expression in patients previously treated with chemotherapy. In April, DS-7300 received rare drug designation from the U.S. FDA for the treatment of SCLC. From Slide 25, I will provide an update on next wave.
Slide 26 introduces a new DXd-ADC that is scheduled to enter clinical trials. DS-3939 is an ADC developed by combining the anti-TA-MUC-1 antibody in-licensed from Glycotope GmbH with our DXd-ADC technology and has a DAR of 8. The target, TA-MUC1, is a transmembrane [ gene ] that is overexpressed in various types of cancers. Our first-in-human Phase I/II study is planned to be initiated in the second quarter of this fiscal year. Please see Slide 27. I would like to introduce another new project. DS-1471 is an antibody targeting CD147. CD147 forms complexes with other factors, and while it is involved in embryogenesis and wound healing in normal tissues, it also plays an important role in cancer cell survival. DS-1471 downregulates complex, thereby inducing cellular stress response and aptotic cancer cell death. Phase I trial is scheduled to begin in the second half of this year. Slide 28 shows other progress of next wave. VANFLYTA was approved for the first-line treatment of FLT3 ITD mutation positive AML and acquired approvals in May in Japan and in July in the United States. EZHARMIA, the top line result of the Phase II study in patients with relapsed or refractory PTCL, was obtained in June. The results will be presented at the future society meetings. DS-5670, our COVID-19 mRNA vaccine, is undergoing booster vaccination study for Omicron strain. In May, a Phase III study started in healthy volunteers aged 12 years and older as well as Phase II/III study for children between age 5 to 11 years. The DS-7011, an anti-TLR7 antibody for the treatment of systemic lupus erythematosus, a Phase Ib/II study was initiated this month. Finally, DS-2325, which is being developed for Netherton syndrome, received rare pediatric disease designation from the U.S. FDA in May.
Slide 29 and onwards show the future news flow.
Slide 30, upcoming conference presentations. At the WCLC in September, in addition to the HERTHENA-Lung01 trial data mentioned earlier, the primary analysis data from the DESTINY-Lung02 study of HER2-mutant NSCLC and the interim data from the TROPION-Lung04 study, first-line plus study for NSCLC without actionable genome alteration in first time will be presented. Expected approvals, the booster vaccination of DS-5670 original strain is expected to be approved in the second quarter of this fiscal year. Key data availability. DESTINY-Breast06 of ENHERTU study in chemo-naive hormone receptor positive and HER2 low breast and TROPION-BREAST01 study of Dato-DXd were previously expected to be available in the first half of the current fiscal year, but it is likely that the data will be available in the second half of the year. The change in the time line is due to the event-driven nature of the study, but the studies, per se, are progressing very well. Slide 31 and the rest are appendix. Please refer to them later for a list of milestone and pipelines. That is all with my presentation.
Now we'd like to go into Q&A session.
First, Mr. Muraoka from Morgan Stanley.
Muraoka from Morgan Stanley speaking. Can you hear me?
Yes, we can hear you.
Regarding Dato's TROPION-Lung01 study, you're proceeding to file your submission. So I believe there is a sufficient possibility of getting approval. I think we need to wait for an academic society meeting for details. There will be a big conference in October as well. Can I assume that we can hear the details before the second quarter results announcement?
Yes, Ken Takeshita here, our Head of R&D, and I can take this question. We have not yet announced the plans for when the data will be announced -- shown at a conference. But once we have those plans, then we'll be right on answer to you at a later meeting. Thank you.
Understood. Again, about the data, TB06 study data. Also in the past, with regards to ENHERTU, the study results were delayed as events were not accumulated, but the results in the active arm actually turned out to be very good. There have been so many good experiences with ENHERTU. I am hoping to have similar expectations this time again. Takeshita-san and Takasaki-san, do you also have the same ideas on your mind?
These are event-driven clinical trials. I think it's -- these events are subject to influence by many, many, many factors. So it is a bit tricky to read into what the clinical trial data might be based on this change in our time lines.
Understood. Lastly, about the transfer of Daiichi Sankyo Espha. Looking at the press release, when you decided to sell, the company had operating profit of about JPY 10 billion. I was a bit surprised to know that it was quite a profitable company. With the transfer, your profit will decrease by about JPY 10 billion on an annualized basis. Can I understand this way?
I'm going to respond. Ogawa speaking. With regards to Espha, while the current format of transactions continues, we will continue to book revenue. At least until March 2024, we are assuming that the current situation will continue. For FY 2024 and beyond, nothing has been decided yet.
May I? In the longer term, should I assume a profit decrease by about JPY 10 billion, roughly speaking? Or because you have transactions with Espha, it's not going to be such a big decrease?
How to book profit from April 2024 has not been determined yet.
Next Mr. Wakao from JPMorgan Securities.
Wakao from JPMorgan speaking. I have three questions about TROPION-Lung01 study results. First, at an earnings call by AstraZeneca last Friday, I was able to confirm AstraZeneca's very strong stance once again. In response, I think your company's share price is rising today. I'd like to confirm you are aligned with them in terms of how to look at the data. In particular, AstraZeneca said, it has confidence in this data. And in terms of safety, the risk-benefit profile is well balanced according to them. Do you have the same opinion? Is my understanding correct?
Yes. There is a very close discussion and partnership between Daiichi Sankyo and AstraZeneca. And we have extensively discussed the results. And I think it's very fair to say that from both sides, we are in alignment with how we feel about the data.
Secondly, about how to handle OS final analysis data. Even if you file a submission based on the currently available data or its interim analysis data, do you still need to submit final OS results? Is there a possibility of the completion of the review just based on the currently available data?
You're absolutely correct that at the current state with the interim analysis, the overall survival data is immature. But we have not announced our regulatory strategy about whether or not OS data is required or not. Once we are ready to disclose that information, then we will certainly relay that to all of you.
Lastly, in your presentation materials, we find wordings such as clinically meaningful. In some press releases, we find the word encouraging. Regarding TROPION-Lung01 study, you are using the word encouraging rather than clinically meaningful. I would like to know the reason why you didn't call it clinically meaningful this time. By looking at the data quality, you are choosing these words. Should I understand that way? In other words, if it's very good, you call it clinically meaningful. If it's in line with the plan, you call it encouraging. That's all from me.
Thank you for that question. I think it's very important to mention that [ PL101 ] is positive data from a statistical perspective. That's very important to note. But the interpretation of the clinically meaningfulness is dependent on the totality of the data available for each of these studies, and they're really the stakeholders' expectations of what's considered meaningful from a risk-benefit perspective. So I don't want to be in a situation where we're trying to hear -- define what a clinical meaningful is from our perspective, because ultimately, it's going to be a data-driven decision based -- for all the stakeholders based on what we will be showing in terms of the data at a future conference and ultimately, the regulatory agencies and also, of course, the final publication of the data.
Then may I ask you an additional question? As of now, OS's interim analysis data without a statistically significant difference. So you cannot use the words clinically meaningful to begin with. Should I understand that way? Just with the currently available PFS and OS interim analysis data, data is not complete. That's why you didn't use that wording. Is that the background? Or it's not relevant.
On your part. And it's difficult for me to confirm the details of our regulatory strategy and how we view our clinical data yet. Once we're ready to do that, we'll certainly inform you of that.
Next, Mr. Yamaguchi from Citigroup Securities.
Yamaguchi from Citigroup speaking. Can you hear me?
Yes, we can hear you.
Earlier, the host server was down on my end. Sorry if you already explained this point before. As for the timing of filing for HER3-DXd, your plan to file in the second half has not been changed. Some time has passed since top line results became available. Did you have interactions with the regulatory authorities already? If yes, any feedback from them? First, I'd like to know whether you have had interaction with the regulatory authorities or not?
Our interactions with the health authorities. And based on that, we are proceeding to -- with our plans to file the data for submission and approval.
That means you think you can file based on the currently available data, correct? That's for Tier 1 or rather Dato. I have a few questions. As for Dato, the status has been changed to proceeding to file the data. Have you had interactions with the regulatory authorities to reach this stage? As was asked earlier by another person, it's possible to file based on the current data. Whether OS data is going to be added on top or not is not disclosed yet, correct?
[indiscernible] informed you about whether or not OS data is or is not required for this submission. It only that we are going to submit.
Lastly, ENHERTU is growing and achieving about 25% of the annual forecast. So I think there is an upside trend for ENHERTU. There can be -- for [ Exactor ] as well, at the current pace, ENHERTU sales are expected to exceed your plan. Is that the right outlook as of now?
Externally, we have not revised our full year forecast this time, as you know. Depending on the progress for the future, if there is a big change, we will update our plan where necessary and make it public to you.
How do you see it right now regarding ENHERTU?
Right now, numerically speaking, as we have announced, it's growing well overall. In terms of indications, geographical regions and the growth in each country, we think it's heading into a positive direction.
Next, Mr. Hashiguchi from Daiwa Securities.
Hashiguchi speaking. My first question is on the Dato-DXd TROPION-Lung01. How do you think about the results compared against the assumption in updated midterm business plan in April?
I think there is some gap regardless of good or net debt. As of now, we are not disclosing any information on that point. We will review the data further. And as Takeshita mentioned, we will give you an update when an appropriate timing is clear, taking into consideration of the status of our interactions and discussions with the regulatory authorities. Well, we are confident that there is a progress, but we would like to further examine the details, and we'll share with you at a later timing.
Another point I would like to ask is on the gap in timing of acquiring the top line results of ENHERTU DESTINY-Breast06 study, is there any possibility that although you expected the significant differences in the interim analysis but it wasn't, so you decided to wait until the next analysis, is that a possibility?
No, this is just a planned analysis that's already factored into the DB06 clinical trial. And as I said earlier, it is an event-driven time point for the analysis, and we're just waiting for those events to happen.
So the timing of the scheduled analysis has changed from your initial forecast, correct?
Yes. It's a number of it. [indiscernible] but's that's correct.
Next, Mr. Sakai from the Credit Suisse Securities.
Sakai from Credit Suisse. Can you hear me?
Yes.
Mr. Ogawa, since you're a presenter, as CFO, this time, I would like to ask you a question. Maybe there are not many investors, so in this based on quarterly performances of your company, but still, share prices react on those performances so let me there ask you.
For the past 1, 2 years, since ENHERTU was launched, I think the volatility on a quarterly basis was very large, if not against the full year. This first quarter seemed to have recorded profit because R&D expenses was limited. Taking that into consideration, regarding the quarterly performance, I think you may have to do some kind of expectation control, if not the prior guidance. The fact that with Lung01 study results, the share price fluctuated greatly, signifies that investors have high interest in the news flow from your company. I would like to ask you an opinion as CFO.
Well, thank you very much for your question. We recognize the high volatility that the companies at every quarterly announcement. We are aware that not only the contents of the announcement, but also top line results as well as disclosures of various data are influencing the volatility. In order to mitigate it, we understand that it is important to do some kind of expectation control. Thank you very much for the precious advice. Into the future, we will try to communicate duly in our IR activities, and at the same time, we will disclose the information as much as we can when possible in order to minimize the level of volatility. It's not that we have some measures that we can think of at the present moment, however, we would like to disclose information when possible and also would like to be mindful of timing to release the information.
One more question on HER3, which you said will proceed to the filing. As was mentioned in the previous question, although it shouldn't be a play of worse, but in HER3 study results, a phrase clinically meaningful was used, whereas in 01 study, no such expression was used. And as a result, market reacted greatly. What do you think about that? I'm not asking about whether the clinical study results were good or bad, but what I'm thinking is that this may be one kind of expectation management. Takeshita-san might be better to answer this question.
Yes, I think it's -- these two trials that you mentioned, the TL01 and HL01, are very different studies with the different endpoints, different study design. So I think in both cases, the interpretation of the clinical data and whether it's clinically meaningful or not, again, is dependent on how all of us build the totality of data. And when I say all of us, I'm not talking just about Daiichi Sankyo, but, of course, the investigators, physicians and the regulatory agencies. So I think it's for these reasons, I -- it's difficult to say why something is clinically meaningful in one situation than another until we can all see the data ourselves and decide whether or not something is meaningful.
Next, from Sanford C. Bernstein, Sogi-san please.
Sogi from Bernstein. I have a question on ENHERTU and tax rate. First about the ENHERTU. In China, you obtained approvals this year, but is it okay to understand that sales are close to 0 now? And about the future, whether you are negotiating in order to be listed on NRDL too and am I right to think that unless you have it on the listing, there is not going to be any sales?
Thank you very much for your question. ENHERTU in Q1, although it's in the form of revenue from the promotion in China, we are booking sales in China. It will be JPY 0.9 billion, but it is recorded. Even though before NRDL listing, it is possible to record the sales. Actually, it will be booked as revenue from the co-promotion activities for us.
Sorry. My question might not be so clear. Thank you for your answer of JPY 0.9 billion. is it part of your strategy to be listed on NRDL, too, for the level of your sales? And before listed on the NRDL, JPY 0.9 billion in China seems to be a small amount, considering the scale of ENHERTU. Is that going to be the amount you are expecting for the future as well?
Thank you for your question. I think you are asking about the prospect and the timing of NRDL listing. We've already submitted HER2-positive breast cancer second line for inclusion in the NRDL. We are not in a position to answer yet on the timing of the inclusion in the NRDL. HER2 low was approved in July. It was after this year's NRDL negotiation cycle, so it will wait for the future timing for filing for NRDL listing. Did I answer to your question?
Yes, thank you. Now about the tax rate. The tax rate was low or negative this year compared to last year. How shall we forecast the tax rate for the next quarters? Is there any guidance that you can give us?
Thank you very much for your question. Let me give you two factors of why it was booked by simplified methodology this quarter. This first factor is that there is a big tax credit on R&D and clinical studies costs. And another is, as I mentioned, the negative impact of the corporate tax at the booking of deferred tax assets due to the decision of stock transfer of Espha. The latter is going to remain for the whole year. Originally, at the time of the forecast of the performance of FY 2023, the tax rate was expected to be 15%. However, the tax rate was lower than expected. And taking into consideration this Espha impact, it will be lower. The Espha influence will be within the range of 5% to 6%.
So the tax credit on R&D expenditure is included in the 15% rate you assumed initially for the fiscal year 2023?
Yes, it is only a matter of the differences of the timing of recording.
Next, Pharmacoeconomics News Company, Mr. Hasegawa, please.
Yes, Hasegawa from the Pharmacoeconomics News Company. Can you hear me?
Yes.
In today's final committee at MHLW, the discussion on your vaccine is likely to take place. If it is approved, how do you proceed on the usage and purchase by the government to be?
Takasaki will answer to that question. I believe that you are also aware that there is going to be a deliberation at MHLW. On our end, we will wait for the results of the conclusion of the discussion. We can only say right now that we will accept and do what we can.
Is there anything that you are discussing with the MHLW on contract regarding the purchase by the central government?
MHLW was closely discussing with us, but we are not in the stage to disclose on what we have agreed upon between the two bodies. So please kindly wait for the future information.
Okay. Then do you have any plan to request strongly from your side with regard to the government purchasing?
Regarding the government purchase, we think the bivalent vaccine covering Omicron on which the clinical study is ongoing right now will contribute more than the original vaccine to the welfare of the Japanese people. So we are including that in our discussion. We are not only focusing on the purchase of our original strain vaccine, but we are discussing with MHLW with wider forecast.
It's now time to finish the meeting. We'd like to close the financial results presentation meeting. Thank you very much for your attendance. [Statements in English on this transcript were spoken by an interpreter present on the live call.]