This is Mr. Okuzawa speaking. Thank you for attending Daiichi Sankyo's financial results briefing despite your busy schedule.
I now explain our financial results for FY 2022 announced at 1:00 P.M. today based on the materials. Please refer to slide 3. This is the agenda in order today. Consolidated financial results for FY 2022 business updates, R&D updates, fifth midterm business plan updates, FY 2023 financial forecast. Our global R&D head, Mr. Takeshita, will present the R&D updates. We will take your questions at the end of the presentations. Please refer to slide four. This slide is a summary of our consolidated financial results for FY 2022. Revenue increased JPY 233.6 billion, 22.4% year-on-year to JPY 1,278.5 billion.
Cost of sales increased JPY 1.0 billion, SG&A rose JPY 118 billion, R&D expenses increased JPY 82.6 billion. As a result, core operating income increased JPY 32 billion, or 35.3% to JPY 122.6 billion. Operating income, including one-time gain and losses, increased JPY 47.6 billion, or 65.1% to JPY 120.6 billion. Net income attributed to the parent company rose JPY 42.2 billion, or 63% to JPY 109.2 billion. The actual ForEx was JPY 135.48 to the dollar, depreciated JPY 23.1 from last year, JPY 140.97 to the euro, depreciation of JPY 10.41 from last year.
Please refer to slide five. From here, I will explain the factors behind the year-on-year ups and downs. Revenue increased by JPY 233.6 billion year-on-year. I will explain the breakdown by BU. First, in Japan business, direct oral anticoagulant LIXIANA and the pain drug Tarlige increased in revenue. Gain on product divestiture in U.S. and Europe outside of the BU's territory also contributed. The revenue declined by JPY 10.8 billion due to a decrease in the sales of Nexium, an anti-ulcer drug for which co-promotion was terminated in the previous fiscal year. Next, I explain about overseas business unit, excluding the impact of ForEx.
In the oncology business, although sales from transferred products in August last year are lost, anti-cancer drug ENHERTU grew in U.S. and Europe. The revenue increased by JPY 84.2 billion.
American Regent, iron deficiency anemia drug INJECTAFER had a lower revenue. Another iron deficiency anemia drug, Venofer, sales increased. ABRAXANE, authorized generic product of HBT that was acquired in August last year contributed, resulting in JPY 6 billion and greater revenue. EU specialty business revenue increased by JPY 11.1 billion, thanks to the growth of LIXIANA sales. Revenue from ENHERTU and Dato-DXd strategic alliance, including upfront and quit lump sum payment increased by JPY 36.4 billion. I explain ENHERTU development milestones later. Many new indications were added, resulting in a total revenue increase of JPY 24.5 billion. In addition, ENHERTU sales milestone of JPY 13.2 billion, or $100 million was posted as a result of achieving a single year product sales of $1 billion in the co-promotion region with AstraZeneca.
The total positive impact of ForEx was JPY 93.9 billion. Please refer to slide 6. This slide shows the core operating income increase and decrease factors. I will explain the JPY 32 billion increase breakdown. As explained, including JPY 93.9 billion positive ForEx impact, revenue increased by JPY 233.6 billion. Next, I will explain cost of sales and expenses excluding ForEx impact. While revenues grew due to the sales expansion of in-house development products like LIXIANA and ENHERTU, resulting in a product mix change, cost of sales ratio improved. Also, the amount decreased by JPY 20.7 billion. SG&A expenses increased mainly due to ENHERTU related profit sharing increase with AstraZeneca. They increased by JPY 74.3 billion.
R&D expenses increased because of investment in three ADCs by JPY 47.6 billion. The total expense went up by JPY 100.4 billion due to Forex impact, the net increase in core operating income excluding Forex was JPY 38.5 billion. Slide seven shows the change in the net income in this fiscal year. As explained earlier, core operating income increased by JPY 32 billion with Forex effect. One-time gains and expenses had a positive impact of JPY 15.6 billion compared to the previous fiscal year.
In the previous fiscal year, the company transferred Osaka Logistics Center to Taiyo Pharma Tech with a JPY 2.1 billion gain on the sale of fixed asset.
In this current period, a gain of JPY 8.1 billion from the sale of Kyushu branch building, a JPY 5.9 billion gain on the sale of Daiichi Sankyo Beijing, and a JPY 3.2 billion gain from the reversal Plexxikon closure-related expenses were recorded. As one of expenses, the company recorded a JPY 10.4 billion impairment loss on XERBOLAV and others, and for former Yasaka plant environmental measures, JPY 9.5 billion. This fiscal year, TURALIO impairment loss was JPY 14.2 billion, and DS-5141 development termination impairment loss of JPY 6.3 billion. Financial income and expenses due to an increase in interest income, financial income increased by JPY 5.8 billion year-on-year. Corporate tax due to increased income before tax increased by JPY 11.1 billion.
As was the case in the previous fiscal year due to the impact of deduction of R&D expenses, the effective tax rate was 13.9%. As a result, net income attributed to the parent company increased by JPY 42.2 billion year-on-year to JPY 109.2 billion. Slide 8 and 7 show the changes in BU sales and major products in Japan on an annual basis. Slide 5 showed BU results excluding Forex effect. However, on the pages, Forex effects are included. I will talk about business update. First, I will explain progress towards maximizing three ADCs in FY2022.
Please turn to page 12. Page 12 shows Enhert revenue breakdown.
FY2022 product sales increased by JPY 142.2 billion year-on-year to JPY 207.5 billion due to the growth in each region, including the United States and Europe. In FY2023, we are forecasting sales to increase by JPY 112.5 billion year-on-year to JPY 320 billion. I will report on the sales performance in each country and region later. FY2022 regulatory milestone payment was up by JPY 24.5 billion to reach JPY 26.7 billion. In FY2022, we obtained approval for HER2-positive breast cancer second-line and HER2-low breast cancer post-chemo in U.S. and EU. In addition, we obtained approval for HER2-positive gastric cancer second-line in EU and HER2-mutant NSCLC second-line in the United States. As a result, regulatory milestone payment increased substantially.
In FY2023, new regulatory milestone payment is expected from the approval of HER2 mutant NSCLC second line in EU. Regarding the regulatory milestone achieved in FY2022, we booked as revenue the total amount for about 4 years from the signing of the agreement to the milestone achievement, so we are expecting JPY 8.3 billion revenue, down by JPY 18.4 billion year-on-year. As FY2022 sales milestone payment, we booked the total revenue of $100 million or JPY 13.2 billion in total as annual product sales of $1 billion were achieved in co-commercialization territory with AstraZeneca. In FY2023, we are forecasting sales milestone of $200 million or JPY 26 billion for achieving annual product sales of $2 billion.
In response, ENHERTU revenue, including upfront, quit-related regulatory milestone and sales milestone payments, rose by JPY 177.6 billion year-on-year to reach JPY 258.4 billion. We are forecasting an increase of JPY 107 billion to JPY 365.3 billion in FY2023. Page 13 shows ENHERTU's sales increase on a quarterly basis since its launch in the Q4 of FY2019 in the United States. Product sales have been increasing steadily due to market penetration and additional indications.
FY2022 Q4 global product sales grew to JPY 67.8 billion. From page 14, I will use two pages to explain ENHERTU sales performance in each country and region. First, FY2022 sales performance in U.S. and EU. In FY2022, there was a large increase in ENHERTU product sales. First, in the United States, product sales in FY2022 were JPY 144.6 billion, or about $1.1 billion. We will aim for JPY 195.1 billion, or $1.5 billion in FY2023. You can see the current indications on this page. In FY2022, HER2-positive breast cancer second-line, HER2-low breast cancer post-chemo, and HER2-mutant NSCLC second-line were added. Market share for each indication is increasing steadily. In HER2-positive breast cancer second-line, ENHERTU is maintaining number one new patient share at the 40%.
In HER2-low breast cancer post-chemo, the new patient share exceeded the 50% level. ENHERTU is maintaining number one position and showing a strong growth at the same time. Based on the great results of DESTINY-Breast03 and DESTINY-Breast04 studies as a trigger, we think ENHERTU is being accepted by patients under clinical settings at a speed far beyond our expectations. The sales performance in Europe is also progressing well. FY2022 product sales was JPY 37.1 billion or $274 million. We will aim for JPY 75.8 billion or $583 million in FY2023. The new patient share in launched countries and regions is also increasing significantly.
The recent new patient share in HER2-low breast cancer second-line was growing a lot to the 50% level in France, upper 30% level in Germany, 40% level in U.K., and upper 40% level in Spain. ENHERTU already won the top position in France, Germany and Spain. ENHERTU is also making a good start in HER2-low breast cancer post-chemo as well. The new patient share is growing to the upper 20% level in France and Germany. In FY2022, HER2-positive breast cancer and gastric cancer second-line and HER2-low breast cancer post-chemo were approved as additional indications. ENHERTU was launched in Spain, following Germany, France and U.K., making a good start.
Page 15 shows ENHERTU sales performance in Japan and ASCA regions. ENHERTU product sales are also increasing steadily. In Japan, product sales were JPY 11.7 billion in FY2022.
We will aim for JPY 19.9 billion in FY2023. You can see the current indications on this page. In FY2022, in addition to HER2-positive breast cancer second-line, HER2-low breast cancer post-chemo, approved in March 2023, was added to this list. New patient share in each indication is increasing steadily. ENHERTU accounts for about 50% in HER2-positive breast cancer third-line, maintaining number 1 share. HER2-positive breast cancer second-line is also making a good start, with the new patient share growing to the upper 20% level. The share in HER2-positive gastric cancer third-line is maintained at the 50% level, keeping number one share.
In ASCA region, product sales were JPY 14.2 billion in FY2022. We will aim for JPY 29.2 billion in FY2023.
Product sales in ASCA region also include alliance revenue in Hong Kong, where AstraZeneca books its revenue. In FY2022, sales were growing significantly in Brazil. In addition to Brazil and Hong Kong, ENHERTU was also launched in Taiwan and Korea. In February 2023, HER2 positive breast cancer second-line was approved in China. We are aiming for launch in FY2023. We will continue to promote further market penetration in sales regions and expansion in launched countries and regions. At the same time, we will promote obtaining new indications and deliver ENHERTU to as many patients in need as possible.
Let me talk about progress towards profit growth for current business and products. Please turn to page 17. Page 17 shows the volume-based share trend for LIXIANA in each country and region. In addition to Japan, Korea, and Taiwan, it's growing steadily in European countries such as Belgium, Spain, and U.K.
FY 2022 global revenue reached JPY 244 billion, up JPY 38.3 billion year-on-year. In FY 2023, we will accelerate growth in each country and region and aim to achieve revenue of JPY 259.4 billion. Page 18 shows the sales value-based share trend in Japan. LIXIANA's sales share decreased due to a drug price revision to lower the drug price because of market expansion repricing in April 2020. LIXIANA has increased its share once again, and it now maintains 43.4% number one share. FY 2022 revenue was up by JPY 12.7 billion year-on-year to reach JPY 105.1 billion.
We will aim for further expansion in FY 2023 with a target to increase by JPY 4.8 billion year-on-year to JPY 109.9 billion. Next, I'd like to talk about enhancing our product portfolio. Please turn to page 19. We have been selling antihypertensive agent, Minebra, since 2019. In Japan in May, we launched a new formulation, Minnebro OD, orally disintegrating tablet. In June, we launched migraine treatment REYVOW, for which we have signed a commercialization collaboration agreement with Eli Lilly. We also launched anti-cancer agent EZHARMIA in December. We have been selling pain treatment Tarlige since 2019, and we obtained marketing approval of its orally disintegrating tablet formulation in September. We are preparing for launch in the first half of FY 2023.
In March this year, we obtained marketing approval of FluMist nasal live attenuated influenza vaccines for the prevention of influenza disease. We signed a licensing agreement for development and commercialization with AstraZeneca's subsidiary, MedImmune. We are aiming for launch next fiscal year. In the U.S. in August, American Regent acquired HBT Labs, Inc., a healthcare company engaging in research and development, manufacturing, sales of generic injectables in oncology area. Through synergies with HBT, we will enhance our product portfolio and aim for further growth of generic injectables business. Page 20 shows other initiatives in each region.
Transformation into a profit structure focused on patented drugs is also making steady progress. In the U.S., we completed transfer of eight products including antihypertensive agent Benicar. We booked $37 million or JPY 5.2 billion as gain on transfer in FY 2022.
In Europe, progress was made in product transfer of antiplatelet agent Effient. We booked EUR 19 million or JPY 2.6 billion as gain on transfer. In ASCA region, we completed transfer of antibacterial agent Cravit in China and the transfer of subsidiary, Daiichi Sankyo Pharmaceutical Beijing Company Limited in China. We booked JPY 5.9 billion gain on transfer. I will talk about FY 2022 progress towards creating shared value with stakeholders. Please turn to page 22. This page is about further enhancement of shareholder returns. Based on the higher than expected sales expansion of ENHERTU, the most important pillar for the five-year business plan.
In October last year, we decided to advance by one year the schedule of dividend increase we assumed in FY 2023 or later and revise annual dividend per share in FY 2022 from JPY 27 to JPY 30.
We will continue to improve capital efficiency and further enhance shareholder returns to maximize shareholder value going forward as well. Next, R&D update. I'm handing over to Global R&D Head, Ken Takeshita.
Thank you very much.
It's a privilege for me to give you an update on research and development activities for fiscal year 2022. Next slide, please. As a summary, I want to mention that we have made major advances in ENHERTU program. This has of course become a very important treatment of breast cancer, particularly in the subgroup of these patients who are HER2-positive and also HER2-low. We can also see that we are making major progress in other HER2-positive targetable tumors. In addition, we are making steady progress in the other two ADCs listed here, the Dato-DXd program and the HER3-DXd program. And previously in many of these other investor calls, you have heard me refer to the Alpha program. This includes all the pipeline drugs outside of the three ADCs.
Today I will update you on how we are doing in terms of Alpha program, including new therapies for hematological cancers. I also want to mention that, we are slowly transforming and transitioning the term alpha so that because you can see the Rising Stars, the DS 706,000. probably starting with our next meeting, we'll be talking about the 5 ADCs and not 3 ADCs, and alpha will remain all the pipeline drugs outside of the 5 ADCs that we have in our active clinical trial pipeline.
Next slide. today I want to update you on our progress in the 3 ADC program. Next slide, please. I'd like to tell you about DESTINY-Breast03 study.
This is the major study that compared our ENHERTU to the old standard ADC called T-DM1. This was an incredibly important study for us because it really established not just the ENHERTU program, but really gave us a huge amount of confidence in our entire DXd ADC technology because it really beat the old standard ADC, the T-DM1. You can see here the overall survival, the hazard ratio was 0.64. PFS hazard ratio was 0.33. We're really talking about reducing the risk of death by 36% and reducing the risk of progression by nearly 70%. The 21% of the patients achieved a CR with T-DXd, which is quite unusual however when patients were treated with T-DM1.
We were very encouraged with these, with this data. This, as you know, led to approvals for ENHERTU in U.S., Europe and Japan, and of course, more recently in China in February 2023. Next slide. This is a slide about our DB-04 study. This is the major study that received a tremendous amount of attention at the last year's ASCO meeting. This is the randomized study of ENHERTU in this new patient segment, which we call HER2-low breast cancer. You can see here again that ENHERTU is compared to standard of care chemotherapy of investigator's choice. You can see here again that the efficacy is really tremendous for both progression-free survival and overall survival.
Of course, as you have just heard, Enhertu was approved for this particular patient population in U.S. and Europe already, and also recently approved in Japan in March of 2023.
Next slide. We are marching ahead in this HER2-low patient population. We consider that we are pioneers in this new patient population. I want to remind you that we have a currently ongoing DESTINY-Breast06 clinical trial, in which patients who are HER2-low and chemotherapy naive are being compared against chemotherapy of investigator's choice. This is a randomized study intended for a registration if the data is positive, we are expecting to see the data sometime in the first half of fiscal year 2023. Next slide.
In addition to breast cancer, we are making tremendous progress in other cancers. You can see here that we are already approved for HER2 positive gastric cancer and also in some countries for a HER2 mutant NSCLC in the second line. It's approved in the U.S. and we are expecting approval sometime in the current fiscal year. We are also making great progress in other cancers which are HER2 positive, you will be hearing more about the data at this year's ASCO occurring about a month from now in both in the colorectal cancer and this other study that's listed here on the lower right-hand corner, the PanTumor02 study, HER2 expressing solid tumors. Please look for our data at the ASCO meeting. Next slide.
Here on this slide, I would like to tell you a little bit about what else are we doing in ENHERTU. I think you'll see that the ENHERTU has become one of the most important drugs in breast cancer. In our research laboratories, we can see that the activity of ENHERTU can be further enhanced with some of our pipeline agents. We are starting to explore this possibility that the research data translates into further clinical benefit in these breast cancer patients treated with ENHERTU in combination with a pipeline agent. We are studying currently or about to study combination of ENHERTU with a new drug called EZHARMIA, which is an EZH2 inhibitor, and also with another drug called DS-1103, which is an anti-SIRPα antibody.
We are seeing very interesting activity in animal models with both of these combinations, and we are very excited to be doing these combination studies in clinical trials now. Next slide. Now we're gonna turn over to the Dato program, and I would like to give you an update first in lung cancer. In fiscal year 2022, we initiated the TROPION-Lung07 study. This is a Phase III randomized study in patients with a low PD-L1 expression in the front-line setting. We initiated this study based on very promising data from our initial study of the TROPION-Lung02 study.
I think you are aware that in the TROPION 02 study, we really demonstrated very good response rates for both a doublet as well as a triplet in this patient population, and that really led us to, you know, conducting the TROPION-Lung07 study. I want to remind you that it is a sister study to yet another Phase III lung, Phase III randomized study called TL08, TROPION-Lung08 study, which is studying the activity of Dato in PD-L1 high patient population. Between TL07 and TL08, we have covered the entire spectrum of NSCLC patients without actionable genomic alterations, the AGA. Next slide.
I want to remind you that we are in addition to the front-line studies, we are making very good progress in the relapse/refractory setting for non-small cell lung cancer in the second-line and plus patient population. The TROPION-Lung01 study is a randomized Phase III study of Dato-DXd versus docetaxel in patients who have been previously treated with for their advanced or metastatic NSCLC. We are expecting the data sometime in the Q1 of fiscal year 23. The other study, a TROPION-Lung05 study that's listed here, is a Phase II study, and we have seen the data from that study. It's a supportive data for our main regulatory study Lung 01. TL-05 alone is not sufficient for registration.
It is really data used to support our main study, which is the TL-01. The TL-05 study will be presented at a future medical meeting. Next slide. In terms of the Dato-DXd breast cancer program, I think you're aware that we have already presented some data on this. In fiscal year 2022, we started two new studies, Tropion-Breast 02 study, which is a Phase III study in PD-L1 ineligible front-line triple-negative breast cancer patients. This is a randomized study comparing Dato DXd versus chemotherapy of investigator's choice. This, we're very excited to be in this front-line setting with Tropion-Breast 02.
We also want to mention TROPION-Breast03 study, which is also a new study for 2022, in which Dato-DXd is being studied in the adjuvant setting. This is a collaboration with a cooperative group, SWOG in the U.S. This is a 1,000 patient study, and this is a study that started in December 2022. I do want to make sure to mention our TB zero one study. This is a very important study, and we are expecting to see some data from this study in fiscal year 2023, the first half. So very, very excited to be looking forward to that study. Next slide. HER3-DXd, this is the third study, I mean, third eight DXd ADC we have in our program.
Our initial registration study is HERTHENA-Lung01, also known as H-L01. We have obtained the data, we are, we can see that the drug shows good evidence of efficacy with durable responses. We are planning to show the data at an upcoming lung cancer conference. I think it's going to be later this year and not at ASCO, but we'll be showing the data at an upcoming Meeting. I want to try to anticipate some of your questions and tell you that we are in active discussions with the regulatory agencies on this study data. I think the data looks quite promising and clinically meaningful.
Please wait for us to show you the actual data and also to hopefully give you an update on our regulatory discussions with the regulatory agencies worldwide. Next slide. In terms of our pipeline drugs beyond the 3 ADCs. Next slide. This DS-7300 is another DXd ADC in which the target is an antigen called B7H3. This was used to be called the Rising Stars. In the future, I think we're going to be including this as part of our 5 ADC program.
We are at the point now where we can update you to say that we are seeing very good results with small cell lung cancer, we have initiated a focused program leading towards registration of DS-7300 in small cell lung cancer. In addition to small cell lung cancer, the opportunities for this drug is quite wide because B7H3, the target antigen, is widely expressed in many other cancers besides small cell lung cancer. We have yet to fully explore the range of activities for DS-7300 in cancers other than small cell lung cancer.
Please help, please wait for us to see more data in more cancer types beyond small cell lung cancer. Next. DS-6000 is our fifth DXd ADC.
It is directed against a cancer target called CDH6, cadherin-6. So far, we are seeing very good activity in ovarian cancer. That... We are initiating a focus program in ovarian cancer. As with the other Rising Star ADC DS-7300, DS-6000 also has yet to be fully explored in many cancers beyond ovarian cancer. We are very interested in broadening the range of indications that we can study. With both of these drugs, we can see that the expression isn't completely dependent on the level of expression.
Like with ENHERTU, we are now studying patients who have lower levels of expression of these target antigens for both 6000 and 7300, and it will be very interesting to see what the clinical data shows. Next slide. In terms of our hematological programs, quizartinib, we have reported the data already, it's with a very good overall survival improvement. We are expecting regulatory action from various regulatory agencies worldwide. I think we're very close to getting approval, so for quizartinib in various countries around the world. I do wanna mention that in the U.S., the FDA did request a special REMS program, which extended the PDUFA date by 3 months.
We don't foresee any problems with the FDA other than to submit an acceptable REMS program. Next slide. This is just a very brief slide to show that we have yet another drug for hematological cancer called ATLL, which stands for adult T-cell leukemia lymphoma. This is a disease that is really unique for Japan and very limited parts of the world. We can see that the activity here for Ezharmia in ATLL is quite good. And on top of that, we have a pivotal registration program going on in PTCL, which stands for peripheral T-cell lymphoma. Which is a disease that is not restricted to Japan but also found in other parts of the world, including the U.S. and Europe.
I do want to mention again here that EZHARMIA also represents a very important strategic opportunity as a combination drug with DXdADCs, including ENHERTU. You will see here on the right-hand side a program in breast cancer as a combination with ENHERTU as part of a much bigger plan for this EZHARMIA drug. Okay, next slide. DS-5670. This is our Daiichi Sankyo original mRNA vaccine for COVID-19. This is really intended for approval and commercialization in Japan. We are really focused now on the development of our booster vaccine.
We have submitted for a regulatory approval of our vaccine for boosters in January of 2023, and we hope to re-receive a regulatory action on our submission in the near future. We are also currently studying and developing additional vaccines, including the mutant strain vaccine as listed here on the lower right-hand corner of this slide. Next slide. Here's a summary of many other programs we have in our Alpha program, Yescarta and DS-9606 in oncology. The vaccine program that I mentioned to you, beyond just the COVID vaccine, we have the FluMist. We also have an RSV vaccine, Phase II program going on. In the specialty medicine area, this is the non-oncology disease indications. We do have very early programs in addition to some mature ones.
Tarlige is a much mature program, really now focused on China development. DS-1211 and DS-2325, these are very early Phase I studies that are really going to be very important for these new specialty medicine programs. I do want to mention that DS-5141, this is an antisense oligonucleotide drug intended for DMD patients, Duchenne muscular dystrophy patients. We have stopped development of this drug because of the difficulty in submitting an NDA with the current dataset.
However, since there are no alternative treatments available in Japan currently, we do intend to provide treatment opportunity to those patients who are still on treatment in a clinical trial and who desire to continue to be treated with this experimental agent. Next slide. Okay.
Finally, in terms of more coming events from an investor standpoint, please anticipate that we will have an ASCO highlights for you in 2023 for the ASCO. This will take place on June 6th, Japan time, on June 5th, U.S. time. Next slide. In terms of the news flow for the coming year, this is a summary of what you can expect in terms of major publications, regulatory decisions, key data, and also planned pivotal study initiation. This really completes my portion of the presentation. Thank you very much.
I, Okuzawa, will explain five-year business plan update. Please turn to page 47.
You can find FY 2025 targets and four strategic pillars to shift to sustainable growth stage. I will use the following two pages to explain the progress for the two years since FY 2021 when our five-year business plan started. Please turn to page 48. Maximizing three ADCs, a huge progress was made in maximizing the product value of ENHERTU. In DB-03 and DB-04 studies, we obtained data substantially exceeding our assumptions under the five-year business plan. Indications of HER2-positive breast cancer second-line and HER2-low breast cancer post-chemo were approved. We also obtained approval for new indication of NSCLC, the 3rd cancer type following breast cancer and gastric cancer.
DB-03 and DB-04 study results were highly appreciated by healthcare professionals. ENHERTU sales were expanding at a rapid pace exceeding the initial plan. In addition, studies for additional indications such as DB-09 study for HER2-positive breast cancer first line are also progressing at a rapid pace exceeding the initial plan. The product value of Dato-DXd and HER3-DXd has also been greatly enhanced over the past 2 years. Steady progress has been made for pivotal study for launch. Multiple Phase III studies are initiated aiming for additional indications after launch. The development of the 2 product is progressing at a speed exceeding the initial plan.
Regarding profit growth for current business and products with additional dosage and administration, sales of LIXIANA with enhanced product value are expanding steadily.
In each country and region, sales of Tarlige, INJECTAFER, Venofer, et cetera, are growing steadily, contributing to enhancement of creating sources of investments for sustainable growth and shareholder returns.
Transformation of business structure focused on patented drugs is also making steady progress. We have launched new drugs such as Engality and EZHARMIA. Product divestiture after loss of exclusivity in each country region is progressing, and profitability is being reinforced. Please turn to page 49. Identify and build pillars for further growth. The development of emerging candidates for new growth driver, Rising Stars following three ADCs, is making progress. In Phase I studies of DS-7300 and DS-6000, we obtained interim analysis data which showed early efficacy signals in multiple cancer types, increasing the potential of both products. There is steady progress to select post-DXd ADC modalities.
We started clinical studies of the second generation ADC DS-9606. Create shared value with stakeholders. In line with profit growth, we decided to increase annual dividend per share for FY 2022 to strengthen shareholder returns. Actions against pandemic risks are also progressing. We filed regulatory submission for original strain booster vaccination for DS-5670. To promote environmental load reduction across the value chain, we joined RE100, a global initiative aiming to use 100% renewable energy for electricity consumed in business activities. We are also making progress in initiatives for environmental issues. We converted electricity consumed in bases in Japan to renewable energy.
By deepening the understanding of the three core behaviors common across our group through workshop by management and employees and organizing penetration of core behaviors, we are fostering One DS Culture for all employees to work vigorously beyond national and cultural borders. As I explained, the four strategies in the five-year business plan are making steady progress. We are becoming more confident about the achievement of FY 2025 targets. I will explain our outlook for achieving KPIs in the five-year business plan. Page 50 is our forecast of achieving FY 2025 KPIs as of now. We are expecting revenue to exceed our target of JPY 1.6 trillion by JPY 400 billion to reach JPY 2 trillion.
A main factor for the increase is revenue in oncology, which is forecast to exceed the target of over JPY 600 billion by about JPY 300 billion to increase to JPY 900 billion or more. Along with the revenue increase, we also expect cost of sales and SG&A cost to increase as well, but we will continue efficient and effective spending. For core operating profit ratio before R&D expenditure, we will continue to aim for achieving our target of 40%. As the development of a pipeline is making steady progress, we will actively execute investments for sustainable growth. By aiming for cash allocation with a good balance with shareholder returns, we expect ROE and DOE to achieve the respective targets of 16% and 8% or higher.
The currency rate assumptions as of April 2023 for KPIs are JPY 130 against the US dollar and JPY 140 against the euro. Page 51 is the forecast of oncology revenue. With the revenue growth of ENHERTU and Dato-DXd exceeding the initial plan and the progress of three ADC development, oncology revenue in FY 2025 is estimated to be over JPY 900 billion. This graph is an image of the revenue expansion during the five-year business plan. For ENHERTU, we are envisioning sales expansion in the breast cancer market based on the DB-03 and DB-04 study results, accelerated studies to expand indications such as DB-09 and DB-11 to drive product sales and regulatory milestone payment, and sales milestone increase by product sales expansion exceeding initial plan to increase the revenue substantially.
As for Dato-DXd, we will aim for launch of the indication of NSCLC in the second line settings and beyond. Sales are expanding from broader target patients compared to the initial plan. With accelerated LCM driving sales expansion such as DL 08 and increased regulatory milestone revenue, we are expecting revenue to exceed the initial plan. Page 52 is about profit share increase for ENHERTU and Dato-DXd. The graph shows an image of profit share expansion during the 5-year business plan. Along with the growth of product sales of ENHERTU and Dato-DXd in countries and regions where we book our revenue, except for Japan, profit sharing with AstraZeneca based on the strategic alliance is expected to increase. SG&A expenses are estimated to go up.
In addition to the profit share increase, cost increase is expected due to the indications where we were not expecting approval during the five-year business plan initially. SG&A cost is expected to increase compared to the initial plan. By executing other spending more effectively and efficiently, we will aim to achieve our FY 2025 goal of 40% core operating profit ratio before R&D expense. Page 53 is 3 ADC launch plan. Studies highlighted in red box are the studies where we did not expect approval during the five-year business plan initially. Due to the cost increase from these studies, R&D expenditure is expected to exceed the initial plan.
All of these studies are indispensable important studies to realize the maximization of the 3 ADCs. Aiming for early approval and promotion start, we try to make proactive investments in R&D. Page 54 shows our R&D strategy.
Due to the increasing potential of growth driver candidates after the 3 ADCs, namely DS-7300 and DS-6000, we revised our R&D strategy from April 2023 and beyond from three and Alpha to 5 DXd ADCs and next waves. To realize sustainable growth, we will make proactive R&D investments for promising pipelines other than the 3 ADCs as well. Page 55 shows the cash allocation to investments and shareholder returns. The source for cash allocation during the 5-year business plan includes cash in hand at the start of the 5-year business plan and the addition of the operating cash flow before R&D expenditure for 5 years. This is expected to increase to JPY 3.1 trillion, up by JPY 300 billion compared to the initial plan due to steady sales expansion of ENHERTU and current products.
Based on the increased source for cash allocation and the pipeline progress, part of the cash to be allocated flexibly to investments for growth and shareholder returns will be used for R&D expenditure and CapEx for further growth into the future.
About JPY 1.8 trillion, which is JPY 300 billion more than the initial plan, will be allocated to prioritized investments for DXd ADC. About JPY 600 billion, which is JPY 100 billion more than the initial plan, will be allocated to CapEx focused on enhancing ADC supply capabilities. We will implement proactive growth investments for sustainable growth. With cash allocation well-balanced with shareholder returns, we will continue to aim for achieving our target of 8% or higher DOE. Over the past two years, we have obtained extremely positive data from ENHERTU clinical studies.
Product sales and milestone revenue are expected to exceed the initial plan substantially. Centering on the clinical studies to expand indications for ENHERTU and Dato-DXd, DXd ADC clinical studies are progressing at a pace exceeding the initial plan. In order to realize FY 2025 targets and 2030 vision, we will continue to commit to shareholder returns we promised, and at the same time, we will spend necessary SG&A cost for future growth, aim for revenue growth, and invest into R&D so that we can realize sustainable growth. Daiichi Sankyo will contribute to the enrichment of quality of life around the world by continuously taking a challenge on providing innovative solutions. Last but not the least, I will talk about FY 2023 forecast. Please turn to page 59.
We are targeting revenue of JPY 1,450 billion and core operating profit of JPY 140 billion in FY 2023. There are factors to decrease the revenue, such as NHI drug price revision in Japan. Sales of main product such as ENHERTU, LIXIANA, and Tarlige will expand. We are forecasting sales increase by JPY 171.5 billion year-on-year to JPY 1,450 billion. Along with revenue increase, cost of sales is expected to rise by JPY 50.9 billion. SG&A expenses are expected to increase by JPY 79.9 billion according to our forecast, due to an increase in ENHERTU-related profit sharing with AstraZeneca. R&D expenses are forecast to increase by JPY 23.3 billion due to an increase in 5 DXd ADCs R&D investments.
As a result, core operating profit is expected to rise by JPY 17.4 billion year-on-year to reach JPY 140 billion according to our forecast. We are expecting the booking of JPY 5 billion temporary expenses for FY 2023, so we are forecasting operating profit of JPY 135 billion, down by JPY 5 billion from the core operating profit. Profit attributable to owners of the company is expected to increase by JPY 5.8 billion year-on-year to JPY 115 billion, assuming the tax rate of 14.8%. Due to the impact of tax credit for R&D expenses and others according to our forecast, the currency rate assumptions are JPY 130 against the US dollar and JPY 140 against the euro. Page 60 shows annual dividend increase in FY 2023.
Sales of ENHERTU, the most important product during the five-year business plan, are expanding with a higher likelihood to achieve major FY 2025 financial targets. We decided to increase dividend payment this fiscal year again following the previous fiscal year. We plan to increase annual dividend per share by 4 JPY from 30 JPY in FY 2022 to 34 JPY in FY 2023.
We will continue to improve capital efficiency and further enhance shareholder returns. We will aim to achieve FY 2025 target of 8% or higher DOE. From here on, we are going to entertain your questions.
Thank you very much.
The first question, Citigroup Securities, Mr. Yamaguchi, please.
Can you hear me okay? Thank you.
This is Yamaguchi from Citi. I ask some brief questions. The presentation was really diverse. Current fiscal year SG&A is expected to grow about JPY 80 billion. As ENHERTU sales increase, payment will be made to AstraZeneca. By excluding AZ payment, there is still some significant increase. What is the nature of the cost? In addition, down the road, excluding fixed AstraZeneca SG&A payment, is the SG&A trending up or it will go down gradually, including infrastructure investment? Tell me the trend in SG&A.
Thank you for the question.
As you understood, in SG&A, the SG&A and AstraZeneca profit share are included. First, AstraZeneca profit sharing. In territories where the S-books product sales meet 40% of payment is incurred. Therefore, please estimate the figure around there. Other than that, as you understood, we are establishing oncology commercialization infrastructure in many countries. By now, U.S. and Europe went in advance and created sales infrastructure and along with indication expansion, promotion investments were made, which are reflected in SG&A in the previous year. In the future, as indications increase, promotion investment will be made as necessary. On the other hand, regarding the infrastructure, our two major strategy oncology area, breast cancer and lung cancer are there. We have created breast cancer infrastructure working with AstraZeneca by now.
From now, in lung cancer with Dato-DXd at the core to co-promote with AstraZeneca in a 50/50 setting, lung cancer sales infrastructure establishment is assumed, which is factored in the future SG&A. As it is a kind of fixed cost in nature, with completion of the infrastructure, it will not keep increasing. Please understand it that way. Thank you.
My second question is about HER3-DXd. According to Mr. Takeshita's comment, the information is not shared in ASCO, I infer WCLC is likely. I know it is difficult to disclose the top-line result, it is tough to know whether the results were good or bad. From Mr. Takeshita's comments, I felt the results were in line with your expectation. Is it correct?
Yes, I can answer that question. We can't really disclose to you yet the actual clinical data, but we're very happy with the data. We think it's clinically meaningful. I hope that's a sufficient answer for you.
Yes. Yes.
Okay.
Regarding that, yeah, the one follow-up question for that is that people worried about because FDA is now changing a stance a little bit to the cautious stance to approve the drug based on the single arm study. Did you talk to FDA or you are still happy with talking to the FDA about this single arm study because it's a breakthrough designated? People bit worried about is there anything kind of changing in the FDA stance may have an impact on this potential filing of HER3-DXd? Thank you.
It's a bit difficult for me to give you the details of where we stand on our regulatory conversations that we're having. I think I can really tell you though that the FDA and other agencies still believe that it's important to bring drugs to patients is very high unmet medical need. I want to remind you that with this HER3 DXd clinical trial, the HL01 clinical trial, these are patients who had 2 prior lines of therapy.
Right.
These are really third line patients, and there's really no treatment available for these patients. You know, I think that's a very important part of the conversation here.
Thank you. Finally, regarding TROPION-Breast01, Which supposed to be come out a little bit earlier, but it sounds like it is expedited as far as the top line data is concerned. Is there any reason behind it or is it in line with your original plan? Thank you.
I'm really happy that you asked that question. The timeline for that study is earlier than planned. It turned out to be a very popular study from the enrollment perspective, we're very happy with that.
Right. Because of the enrollment is quicker, that's why the top line comes out quicker, right?
That's correct.
JPMorgan Securities, Mr. Wakao, please. Wakao from JPMorgan,
thank you for the opportunity. Tell me about slide 56. You extended investment period a little, and this fiscal year became part of the investment period. Not sure if at this next fiscal year or fiscal year after the next you will move to profit growth period. What are their definitions? FY 2025 absolute operating profit amount is up or down from your previous targets. Concerning increase in R&D expense and growth in the top line, the absolute amount does not change that much. That's what I felt. Tell me about the number. Thank you for your question. Between investment period and profit growth period, regarding what are the changes and how they are implemented.
As shown in the 3 ADC launch plan slide, in the initial mid-term business plan, we had 3 ADCs new indications plan for the 5 years. Compared to the plan, we have greater number of indication expansion studies as presented. From that viewpoint, we are in at the middle of our current mid-term business plan because we are in FY 2023. If we followed our original clinical trial plan, R&D investment would have been slowed down around now. On the other hand, in the background of still increasing R&D investment, the expectation of approvals in the 5-year period and the prospect to have 5 ADCs rather than 3 ADCs, new growth drivers are there. Given that, we continue to invest in R&D. That is a change in the situation from 2.5 years ago. We are still in investment period because of the reason.
Regarding the other question about FY 2025 absolute profit amount, core operating profit ratio before R&D is about 40%, which stays the same. We are confident about the number. On the other hand, we need to do the math. By now, JPY 1.6 trillion was a base amount, but it's now 40% of JPY 2 trillion. In that sense, before R&D expenses, the investment basis as an absolute amount is up compared to the original mid-term business plan numbers. That is a factor. How much of that base is earmarked for R&D investment and how much is retained as earnings are then considered. As the background to set this KPI in the current mid-term business plan, we have stated the management will make allocation decision looking at the pipeline progress. That is still ongoing. In the future, we intend to make decisions that way.
FY 2025 profit forecast in the mid-term business plan 2 years ago and updated FY 2025 absolute amount forecast, if you compare current forecast is not inferior at very least, I note. Thank you. R&D budget was changed from JPY 1.5 trillion to JPY 1.8 trillion, an increase of JPY 300 billion. It's not a small amount. This time, shift from 3 ADCs to 5 ADCs. In addition, you invest in next wave. A general thought is that early-stage projects are not very expensive, so that I assume that you decided to conduct large-scale clinical studies. Is my idea correct? In other words, Enhertu HER2 low adjuvant study or other extensive large-scale study implementation is already envisioned. Thank you for the question. Basically, 3 ADC product v-value maximization contribution is our first strategy. New growth driver is our third strategy. We intend to focus on those.
Basically, your understanding is correct. Especially regarding ENHERTU, DB-03 and DB-04's excellent data are received very favorably by healthcare professionals. With heightened expectation of the product, not only in clinical practice use, but also in clinical trials, motivation to actively participate in ENHERTU indication expansion clinical trials are enhanced, resulting in an acceleration of the clinical trials moving up the timeline. That is a stethoscope. Last, just a simple question. I suppose DS had a big expectation about TROPION-Lung01. It has not changed? Correct. Thank you. That's all from me. Next, Mr. Hashiguchi from Daiwa Securities, please.
Thank you very much. I have a question about the Core Operating Profit Ratio before R&D Expenses as FY 2025 financial targets of your five-year business plan. This time, you have made a substantial upward revision of your revenue forecast from JPY 1.6 trillion to JPY 2 trillion, but the margin has not been changed. How should I understand this? Could you please explain again?
You are asking why we are not changing the 40% margin before R&D cost?
Yes.
Usually, when revenue increases, margin improves in many cases. Yes. This was one of the main KPIs in the initial midterm business plan. This 40% core operating profit ratio before R&D expense has been newly set up as a KPI. As I said before, we regard this as a source for continuous R&D investments. While the top-line revenue increases, if it's going to be at the same ratio, the absolute amount of the source is going to be bigger. We'd like to use the bigger source of money to allocate to promising pipelines more than 2 and a half years ago. In order to secure such a source of money to contribute to the enhancement of sustainable growth and sustainable corporate value of Daiichi Sankyo, we would like to maintain the same 40% ratio also for the top-line revenue target of JPY 2 trillion.
This is the core operating profit ratio before R&D expense. I don't think an increase in R&D cost cannot be a reason for this. What do you think? Sorry, could you repeat your question, please? This is the core operating profit ratio before R&D expense. I don't think an increase in R&D cost cannot be a reason for no change in the margin, in my view. What do you think? Let me explain a bit on behalf of Okuzawa. Regarding your question, revenue increase mainly consists of ENHERTU and Dato-DXd sales increase. As Okuzawa explained, profit sharing with AstraZeneca is about 45% of revenue. Profit margin before R&D cost vis-à-vis revenue increase is much lower compared to other usual products.
In addition, costs to put infrastructures into place for lung cancer and new indications are also included in our assumptions. At this stage, we cannot expect usual profit increase along with the revenue increase. That's why we are maintaining the same 40% margin. I hope you understand this way. Okay, understood. Thank you. One more question. About DS-5670, you mentioned that the data did not demonstrate non-inferiority to community in the development of primary vaccination. What do you think is the reason why? In the future application to various pipelines, could you please share your view on the competitiveness of your messenger RNA technology based on the results you presented?
Yes. Let me just very briefly comment on this question. Yes, for the for the original monovalent vaccine, it did not show non-inferior. I wonder, of course, whether that particular clinical trial and that vaccine is really relevant to Japan anymore, since the vast majority of patients, of people in Japan have been vaccinated. We have, as you know, obtained a very good data on the subsequent program. In fact, we have submitted that for approval. From a standpoint of how does that non-inferiority clinical trial negative data impact the entire mRNA vaccine program, I think that because we have more positive data in other settings with other vaccines, and including the mutant vaccine that we are currently developing.
We remain very confident in our mRNA vaccine technology. Not just for COVID, but also its further applications in other infectious diseases and possibly beyond that.
Thank you. That's all from me. Thank you very much. Next, Mr. Muroka from Morgan Stanley, MUFG Securities, please. Hello, Muroka from Morgan Stanley. Can you hear me? Yes, we can hear you. Thank you. I have a question about the math behind your five-year business plan. JPY 1.8 trillion R&D expenditure. Your budget this fiscal year is JPY 360 billion. If I subtract that amount, JPY 850 billion remains. In FY 2024 and 2025 at this pace, JPY 400 billion and JPY 450 billion respectively. Spending like this will come to my mind looking at your numbers. Calculating this way is not far away from your plan, roughly speaking. Thank you for your question. As you said, this is exactly the world of math.
JPY 1.8 trillion will be spent over 5 years, subtracting the amount we already used for the past 2 years, as well as the amount we are planning to use in FY 2023. We will spend the money in FY 2024 and 2025 at the level as you mentioned. Understood. Thank you. Regarding R&D, you're going to present DESTINY-PanTumor02 data at ASCO. I'm looking forward to your ASCO presentation, but you didn't mention filing with FDA in your presentation today. What's your plan for submission?
I don't want to yet comment on what we will do with the pan-tumor data. I think I just want to because we have not made that information public. It is very important piece of data in many other cancer types which happen to be HER2 positive. That's a very important consideration in terms of interaction with the FDA. I hope to give you more update on this after ASCO and after our regulatory plans have been finalized.
Thank you. Finally, I have a brief question. CapEx will be increased by JPY 100 billion in the five-year business plan. Is this because of Forex? I'm sure the volume is increasing. If that's the case, is it due to ENHERTU, or you need to manufacture Dato-DXd more to invest into Dato-DXd? Now that you come to know that you're planning to invest more into Dato-DXd actively, could you elaborate on this, please? Our plan to increase CapEx by JPY 100 billion includes CapEx for ADC and vaccine related facilities. That's one point to note.
As for ADC, as we announced our initial plan two and a half years ago, we plan to spend JPY 500 billion to be able to address the supply during this five-year business plan period. This time, we're increasing CapEx forecast by JPY 100 billion to be able to handle an increase in demand for ADC in FY 2026 and beyond. I hope you can understand this way. Understood. That's all from me. Thank you very much. Thank you. This is going to be the last question. Mr. Ueda from Goldman Sachs Securities, please. Ueda from Goldman Sachs Securities speaking. I have just one question. On page 51, you have shown us a graph on revenue increase from ENHERTU, Dato-DXd, and HER3-DXd. I want to confirm the changes. Earlier, you explained major factors increased from the initial plan shown on the right-hand side.
In reality, there may be ForEx impact as well. What are the major changes in particular? There seems to be a smaller expectation for HER3-DXd right now. Are you doing probability adjustment? Promising data you obtained recently is not factored in. Are there any such factors behind? Could you elaborate on your assumptions, please? You are asking about page 51, where we are showing revenue to increase from ENHERTU, Dato-DXd, and HER3-DXd. Our initial target was JPY 600 billion, we are increasing this by JPY 300 billion to JPY 900 billion. Roughly speaking, increase from ENHERTU will be about JPY 250 billion. About JPY 40 billion increase will come from Dato-DXd. Combining the two, about JPY 290 billion. The rest will come from other oncology products. That's the breakdown of JPY 300 billion.
As of 2025, ENHERTU on a standalone basis is expected to exceed JPY 600 billion according to our forecast. Could you please repeat your question on HER3 once again? Dr. Takeshita commented earlier that he's confident about HER3-DXd as promising data has been obtained. That is not factored in, so HER3 revenue is very small here. HER3 revenue is too small to see, in my view. What's your assumption here? Thank you for your question. In our future interaction with the regulatory agencies, we will be able to clarify such assumptions more. We'd like to discuss with you at an appropriate timing. Thank you for your understanding. Understood. That's all from me.
Thank you very much. Now it's time to finish.
We are closing Q&A session with investors and analysts. We thank you all for joining this meeting today. Thank you very much.