Now it is time to start the financial results briefing session for the first quarter of FY 2022 of Eisai Co., Ltd. Thank you very much for your participation despite busy schedule. For this meeting here today, in the beginning, we considered to have this as the venue and online-based hybrid presentation meeting. Due to the COVID-19 pandemic situation recently, we decided to have the live streaming and telephone line online type of the meeting. I believe some of you are here through the telephone line. In that case, please come to our website so that you can find our presentation material. Today's presentation financial part is going to be given by the CFO, Chief IR Officer, Tatsuyuki Yasuno. Neurology Part, Global AD Officer, Ivan Cheung. For Oncology Part, Chief Scientific Officer, Takashi Owa.
Those are the presenters for today. When it comes to the presentation by Ivan Cheung, it's going to be given in English. For Japanese, you can listen to the simultaneous translation. Thank you very much. Now let's get into the presentation. First of all, about the financial part, Yasuno is going to give you the presentation. Mr. Yasuno, please.
Thank you for the introduction. My name is Yasuno. I am CFO. First, I'd like to explain the Q1 consolidated statement of income for fiscal year 2022. During the quarter under review, due to the progress these growth of organic business, progress as expected was seen both in revenue and profit. For revenue, global brands grew 146.6% of the previous year, and it was the significant growth by JPY 29.4 billion year-on-year due to significant impact of upfront payments related to MORAb-202 of JPY 49.6 billion received in the previous year. The revenue was 93% of the previous year at JPY 148.3 billion. Cost of sales ratio was up six percentage points to 25.7%.
However, it was controlled within the fiscal year 2020 before level. R&D expenses accounted for 20.9% of the sales at 92% of the previous year at JPY 38.5 billion in R&D expenses. However, considering the reimbursement from the partner, R&D expenses were up 7% at 56%. We are making proactive investment in growth. SG&A expenses are JPY 92.3 billion, 123% of the previous year, and increased by JPY 17.5 billion from a year earlier. LENVIMA's growth expansion driven these expenses as well. The shared profit of our partner was 11.9%, and these were the factors for increase. The FX had a positive impact of JPY 11.9 billion on overall SG&A.
Excluding this impact and increase in the shared profit paid to Merck, the expenses are managed below the previous year's level. Other income expenses were JPY 1.4 billion for this year. As a result, OP was JPY 7.4 billion, 13% of the previous year. As explained earlier, there was one-time factor in the previous year, such as the upfront payment related to MORAb-202 of JPY 49.6 billion and the Zonegran divestiture of rights of the Zonegran as well. OP decreased, but as we originally explained, expected that there will be a growth from the second quarter onward. The progress has been in line with our expectation. Profit for the period was JPY 28 billion, 66% of the previous year.
Profit for the period attributable to owners of the parent was JPY 26.9 billion, 64% of the previous year. This, against the forecast of the full-year, JPY 57 billion, the progress is 47%. Quite high progress. This was due to the company's recognition of losses on sales of investments in subsidiaries for tax purposes following a repayment of paid-in capital from a U.S. sub to the company in order to collect the capital from the U.S. sub as part of company's capital policy to optimize the global allocation of cash in the company. Ratio of equity attributable owner of the parent was up 2.8 percentage points to 63.2%. Net D/E is -0.28 x. The net cash position is JPY 221.4 billion.
We have still continued to have ample net cash position, debt-free status with optimal capital structure. Next slide, revenue migration is explained. On the left-hand side, JPY 198.9 billion was recorded as revenue for the first quarter a year earlier. This quarter, revenue was JPY 184.3 billion, down JPY 14.6 billion. Now breaking down into pharmaceutical business and other business. In pharmaceutical business, revenue increased by JPY 34.1 billion year-on-year, up 23% from a year earlier, achieved a double-digit growth. This is mainly due to the growth of all the four global brands of HALAVEN, FYCOMPA, DAYVIGO, in particular LENVIMA, which were all above plan and grew JPY 29.4 billion, because of the strong growth in these brands as well.
Other businesses, we saw the decrease in revenue, year-on-year decrease of JPY 48.8 billion. But as I said earlier, this was due to the upfront payment for MORAb-202 of JPY 49.6 billion in the previous year. Overall revenue decreased, however, our pharmaceutical business grew strongly with double-digit growth rate. Next, breakdown of operating profit margin is explained here. On the left-hand side, JPY 55.3 billion was recorded as operating profit for the first quarter of last fiscal year. This term, OP was decreased by JPY 7.4 billion. As you see on the right, the breakdown is provided. Gross profit increased, as you see in the blue portion.
Because of the increase in the revenue in pharmaceutical business, the gross profit increased by JPY 26.7 billion from a year earlier. On the other hand, because of the one-time receipt of the one-time upfront payment in the previous year, the overall OP decreased by JPY 22.8 billion year-on-year. R&D expenses. Due to increased efficiency through utilization of the partnership model, such as reversal of R&D expenses of JPY 3.2 billion, regulatory milestone payment for the approval and reimbursement of renal cell carcinoma in the EU and India. Although we made the proactive investment resources into lecanemab. As you can see in the bottom, the actual R&D expenses, including expenses borne by partner, show that we have been continuing to make proactive investment in AD and oncology.
The SG&A expenses increased by JPY 17.5 billion because of the impacts of ForEx and also increase in the shared profit for LENVIMA paid to Merck. Due to the factors in the revenue in the previous year, OP for the first quarter decreased year-on-year, but profit in pharmaceutical business was JPY 90.6 billion, up 33% year-on-year. Due to the expansion of global brand in oncology business, we have been able to secure high profitability. An OP level in this first quarter may seem to be low, but we are proactively investing resources in R&D such as lecanemab and LENVIMA. Please consider that this is partly due to the difference of timing to receive milestone payments as return of shared profit with partners for the future growth of LENVIMA and other strategic options.
We hope that you will assess our profitability not from the short-term perspective, but for full-year or several years. Next, I would like to talk about LENVIMA, which is driving our revenue. LENVIMA has established a very strong positioning as the backbone therapy for six indications in five site cancer types. In all regions, it achieved a double-digit growth. During the first quarter, revenue was JPY 66.3 billion as a global total, was up 50% year-on-year, against the full-year forecast, with the progress rate of full-year forecast of 30%. On the right-hand side, the largest market for us, Americas, omni-channel marketing has been adopted to a wide-ranging indications, and we have taken back the share in HCC in particular.
The LENVIMA and KEYTRUDA has established a top share in the market of endometrial cancer first position in patients following prior systemic therapy, and it is expanding share. In RCC as well, the prescriptions are steadily growing, and by the end of fiscal year 2022, we are going to obtain top share. The second-largest market for us, China, even after generic entry, hepatocellular carcinoma market, we are maintaining the top share. LENVIMA is the only TKI recommended in expert guidance on HCC local therapy, and it has shown growth significantly over the previous year. In EMEA, Japan, Asia, it has shown strong growth and we are making very steady progress towards achievement of the target for this fiscal year in LENVIMA. Next, I would like to ask Ivan Cheung to report to you the progress on new AD area.
This is Ivan Cheung, responsible for Alzheimer's disease and brain health. Today, I want to give an update on the tremendous progress we have made with the lecanemab program. On slide five, as we can see in the top box, we successfully secured priority review from the FDA with PDUFA action date on January 6th, under the Accelerated Approval pathway, which we believe is a critical regulatory strategy to speed up our ultimate goal for lecanemab, to become the first AD-DMT to achieve full approval. As the FDA will have essentially reviewed all the necessary components outside of Clarity AD results. We reiterate our target to file for full approvals in the U.S., Japan, and the EU within this fiscal year. In the middle box, you can see that we are on schedule for Clarity AD top-line readout by end of September, in two months.
We are very happy with where Clarity AD stands right now. As you see in the first bullet point, the statistical power of the study is now at 93%, very high, because of not only the very large sample size in this trial, but also lower than expected discontinuation rate and well-controlled variability. In addition to the 1,795 subjects for primary analysis, we've also enrolled a cohort of 111 subjects in China, which is a unique feature of this study not seen AD-DMT phase III trials. In the second bullet point, which is a very encouraging aspect of this trial, we have almost 70% of the enrolled subjects being ApoE4 carriers. As many of you may remember, in Study 201, we saw very clear trends that these individuals are better responders to lecanemab treatment.
One more update on the third bullet point here. The independent data and safety monitoring board so far not raised any new safety concern, including ARIA-E. We expect the incidence of ARIA-E in Clarity AD to stay low, similar to Study 201 at around 10%. In conclusion, we remain very confident in lecanemab becoming the first AD-DMT to achieve full approval in the world. Next slide on slide six, please. Foundational to our launch preparation for lecanemab is building trust with the public about lecanemab's clinical data and value. We are fully committed to publications in peer-reviewed journals, and we have proven track record in doing so.
In the middle box in pink, as you can see, the first bullet point, the primary manuscript of Study 201 was already published in Alzheimer's Research & Therapy, which concluded that pre-specified analyses demonstrating reduction in brain amyloid, accompanied by a consistent reduction of clinical decline across several clinical and biomarker endpoints. Secondly, the long-term health outcomes and potential economic value of lecanemab using a modern simulation model based on Study 201 were both published in Neurology and Therapy, which I'll explain later on in my presentation. We're now in the process of preparing submissions of additional data and analyses from Study 201, such as ARIA-E analyses and modeling for maintenance dosing regimen to peer-reviewed journals. More importantly, we are fully committed to timely publication of the primary manuscript for Clarity AD results in a peer-reviewed journal.
Meanwhile, we have initiated discussion with the coverage and analysis group at the CMS responsible for the NCD with regard to how the rich data to be generated from Clarity AD can fulfill CMS criteria for high level of evidence to enable timely reconsideration for broader access for lecanemab upon full approval. In summary, we will ensure full transparency of the body of knowledge around lecanemab so that we can achieve our mission to help people living with Alzheimer's disease and their families. Next slide seven, please. We believe blood biomarker diagnosis is the most important element to simplify the patient journey, and therefore enlarge AD-DMT market, which is most beneficial, obviously, to a potentially market-leading therapy like lecanemab.
On the left-hand side of the slide, we estimate that the market size for AD-DMT-eligible early AD patients who are potentially available to treatments such as lecanemab across eight major markets will reach about 2.5 million individuals by 2030. Which is obviously enormous market potential, driven not only by the U.S., but also other key markets such as China, which we have an advantage through our unique China strategy in Clarity AD that I mentioned just earlier. The key to accelerating the AD-DMT market expansion, as you can see on the right-hand side, is wide adoption of blood tests as a replacement for PET and CSF to confirm amyloid positivity diagnosis, as you see in the bottom part of the right-hand side, instead of just a screening tool to rule out amyloid negative individuals, as you see in the upper part of the right-hand side.
With rapid advancements in improving both sensitivity and specificity of blood biomarker diagnosis, such as multi-assay approach combining Aβ42/40 ratio and p-tau, we believe the AD-DMT market will accelerate and expand quickly within five years from now. Next slide on slide eight, please. Pricing, of course, is a critically strategic item for lecanemab going forward. We will follow value-based pricing principle for lecanemab, and we will transparently publish all our methodology and rationale. As you can see on this slide, in April this year, we successfully published the long-term health outcome model based on Study 201 in a peer-reviewed journal.
Results from this subject level model, given that AD is a heterogeneous disease called AD ACE model, demonstrated delay of progression from early AD to moderate AD by 3.13 years on average by lecanemab versus standard of care, which you can see on the left-hand side in the upper box. This model predicted lower lifetime probability of needing institutional care at 25% with lecanemab versus 31% for standard of care, as you can see in the lower left box on the slide. In May this year, we have another paper successfully published in a peer-reviewed journal that takes these long-term health outcomes that I just explained to you and calculates the medical and societal value of lecanemab.
The value-based price range of lecanemab in the base case is predicted to be up to approximately $38,000 annually to the society, as you can see on the slide. In conclusion, we are confident that lecanemab will improve long-term health outcomes and reduce care costs, resulting in very meaningful value-based price range to the society. To reach our final pricing decision on lecanemab, in addition to the value of lecanemab, we will have to take into account health system sustainability as well as patient affordability as two other key important factors. Next slide, on slide nine, please. This is my last slide. Our leadership, Eisai's leadership in Alzheimer's disease goes beyond lecanemab and covers the entire continuum of A/T/N.
Phase III program for lecanemab is not only in early AD, as you can see on the left-hand side of the slide, but also in preclinical AD with AHEAD 3-45 trial in conjunction with ACTC and also combination regimen with our anti-MTBR tau antibody, E2814 in collaboration with DIAN-TU NexGen trial. We also have E2511 and E2025 in phase I, targeting the synaptic microenvironment in the brain. One small molecule, one antibody. Overall, we have conviction that Eisai will continue to lead in Alzheimer's disease with the most comprehensive pipeline spanning across A/T/N. Let me also draw your attention at the bottom of the slide to E2086, our in-house novel orexin agonist under preparation for IND submission now based on Eisai's expertise in the orexin pathway.
For E2086, we will initially target narcolepsy, which is a chronic neurodegenerative disease caused by deficiency of orexin. E2086 has a unique chemical structure that offers differentiated efficacy and safety profile based on preclinical data. We look forward to initiating phase I within this fiscal year. Thank you very much for your attention. Now let me turn it over to Dr. Owa.
Next slide, please. Yes, thank you. This is Owa speaking. I'd like to give you the update on the oncology pipeline. First, as for LENVIMA, I would like to give you the progress in lead studies. On the left-hand side of this slide, you can see the summary of top-line results of LEAP-002 study for hepatocellular carcinoma first line, on which we made a news release on August the third. This study is designed to evaluate the effect of adding KEYTRUDA in combination with LENVIMA, which is an approved drug for first-line treatment for HCC. Statistically significant difference per pre-specified statistical plan was not confirmed for dual primary endpoint of OS and PFS between LENVIMA plus KEYTRUDA combination and LENVIMA monotherapy. However, it is considered nothing but to suggest how excellent LENVIMA monotherapy is as used as comparator in this study.
There were trends towards improvement in OS and PFS for patients who received the LENVIMA plus KEYTRUDA versus LENVIMA monotherapy, and the median OS of the LENVIMA monotherapy arm in this study was longer than those observed in previously reported clinical trials evaluating LENVIMA monotherapy in HCC first line. Furthermore, the combination therapy of Tecentriq, an approved anti-PD-L1 antibody for the same treatment line, plus Avastin, an anti-VEGF antibody, was reported to achieve the median OS of 19.2 months in the OS update published in December. Even when taking into account that this is not a head-to-head comparison of studies with identical patient background, LENVIMA monotherapy in this study is considered to have shown OS data comparable to that of Tecentriq plus Avastin combination. Details will be reported in academic conference in the near future.
We aim to utilize this very valuable data from LEAP-002 study to enhance contribution to patients with HCC by solidifying LENVIMA's position as the first drug of choice in HCC first line as the current recent status in the U.S. market. Next, please look at the right-hand side of the slide. Now, other ongoing lead studies are designed to evaluate the add-on effect of LENVIMA being added to KEYTRUDA monotherapy or combination therapy, including KEYTRUDA. This is in contrast to the design of LEAP-002 study. Here, I would like to explain our analysis of the current status of LEAP-006 and LEAP-008 for first-line and second-line treatment of NSCLC with particularly large number of patients who may benefit from medical treatment.
First, LEAP-006 study is designed to test the significant difference in two primary endpoints of OS and PFS by adding LENVIMA onto KEYTRUDA plus combination chemotherapy. In this study, LENVIMA's dosing combination is 8 mg, which is lower than the approved dose of 20 mg in combination with KEYTRUDA for RCC and endometrial carcinoma. Independent Data Monitoring Committee has not raised any particular safety concern so far at its meetings, and manageable safety profile was shown in dose evaluation part of this study. As for efficacy, a favorable ORR of 69% was observed in the dose evaluation part. This 69% is well above the approximately 50% level reported in literature for the comparator arm of KEYTRUDA plus combination chemotherapy. Next, LEAP-008 study.
This study is designed to test the significant difference in dual primary endpoints of OS and PFS in comparison of LENVIMA plus KEYTRUDA versus docetaxel monotherapy. LENVIMA's dose in combination is 20 mg, and IDMC has not raised any particular safety concern at its meetings to date. As for efficacy, in NSCLC second-line cohort of basket-type phase I-B/II study carried out before this study, promising data with ORR of 33% and median DOR, duration of response of 10.9 months were obtained. This ORR is well above the ORR of about 10% with DOR of four to five months, which have been reported in literature for the comparator docetaxel. This LEAP-008 and LEAP-006.
In this patient population of NSCLC first-line and second-line populations, treatment outcome, there hasn't been any new drug, so it may transform the treatment outcome, particularly survival benefits. Therefore, it will be reasonable to some extent to surmise OS and PFS based on ORR and DOR values. LENVIMA is different from other VEGFR pathway inhibitors, and it inhibits FGFR. NSCLC is known to have relatively high dependence on FGFR pathway, and we consider that may be involved in the enhancing antitumor effect activity of LENVIMA. Given this, our expectation to obtain desirable data from these studies has remained intact, and we intend to make necessary preparations with confidence. Global annual sales target of JPY 500 billion also remains unchanged for now. Next slide, please. Next, MORAb-202, farletuzumab ecteribulin, development status is to be updated.
This is from the presentation made at the ASCO in June. We would like to give you the summary of the efficacy and the safety data of this ADC drug for patients with high-grade serous platinum-resistant ovarian cancer in Study 101. In the waterfall plot on the left shows the Cohort 1 with 0.9 mg/kg and Cohort 2 with 1.2 mg/kg . You see tumor shrinkage effect of MORAb-202 is visualized here, and you can see the highlights of efficacy on the right-hand side. ORR in Cohort 1 was 31.6%. In Cohort 2, 50.0%. Compared to the publicly known information for this particular population, remarkable values were observed.
Particularly, there was not a substantive difference in ORR between above and below the 50% cutoff of the folate receptor alpha expression level. We consider that this is due to the clinically validated bystander effect of MORAb-202. The safety profile for this ADC drug was manageable in general. The most common TEAE was interstitial lung disease, ILD. The observed ILD in Cohort 2, there was only one Grade 3 case in Cohort 2. But excluding that, all of the other cases were Grade 1 or Grade 2, which did not require oxygen inhalation or discontinuation. ILD incidence was 37.5% in Cohort 1 and 66.7% in Cohort 2. Relatively high values were shown.
Because of the timing of this study, which coincided with the time when COVID-19 infection spread, therefore, we believe that this was due to certain level screening effect. Please turn to the next slide. In this slide, we have considered various measures and to reduce the risk of ILD, and this is the result. In this presentation at ASCO, a body weight-based dosing were compared to a body surface area-based dosing, and looked at the impacts on the efficacy and the safety. Based on the actual clinical data, 1000 virtual data points were used for conducting modeling analysis. Please look at the table on the left. Here, for a person of 60 kg in body weight and the standard body surface area is estimated to be about 1.6 sq m based on this criteria.
That there were groups of nine, 0.9 mg/kg administration MORAb-202, Q3W, and the body surface area based dosing of 33 mg/sq m every three weeks. Comparing these two groups and the four quartiles by body weight and overall group were compared in ORR and ILD incidence. First, for ORR, BSA dosing, as you see in blue box, in the heaviest group as well, ORR above or at 30% was maintained. Regarding ILD incidence, please look at red box portion. Risk was reduced by about 35% in BSA dosing group compared to body weight dosing group. Based upon this result, we revised, amended the protocol for the study, and we prepared ILD risk management manual. With the agreement of FDA, we changed the dosing to BSA-based dosing.
Together with partner BMS, we are accelerating clinical development. Please look at right-hand side. Our folate receptor alpha-positive cancer with FRα dependence includes the ovarian cancer, endometrial cancer, NSCLC, and breast cancer. Total number of patients is expected to exceed one million in 2025. The Study 201 targeting ovarian cancer and endometrial cancer, we will complete the BSA-based dose confirmation in 2022 to move on to the phase II part. For new phase II study for ovarian cancer and NSCLC, we are going to start by the end of the year. We are making preparation with the clinical team of BMS. In fiscal year 2025, we'd like to submit for either of the three types of cancer. Next slide.
I'd like to talk about the medium molecule E7386 first-in-class molecule. You can see the chemical structure formula in top left corner. Now currently, this is being developed as the oral peptide mimetic medium molecule drug to inhibit the protein-protein interaction between CBP and beta-catenin at the downstream of a Wnt signal pathway. This, if CBP beta-catenin interaction is inhibited, and then what will happen, please look at the two sets of preclinical data on the right-hand side. Based on the results from the left-hand model of a human HCC cell line, SNU-398, there was significant reduction of non-responsive tumor microvessels involved in the resistance to LENVIMA in combination of E7386 plus LENVIMA. That means that the green bar shows the density of LENVIMA-resistant microvessels in tumor.
In the combination of E7386 and LENVIMA, you can see the significant reduction in the density, as you see in the red bar. On the right-hand side, in the model of mouse breast cancer cell line, 4T1, E7386 released the suppression of T cell infiltration involved in the KEYTRUDA resistance. The number of CD8 positive T cells increased in tumor. The effect was found in this E7386 monotherapy and a combination therapy with anti-PD-1 antibody. Based on this preclinical data, the study is ongoing for both combination of the E7386 and LENVIMA and E7386 and KEYTRUDA.
In the Study 102, PR was observed in multiple cases in patients with HCC whose disease progressed after prior therapy with LENVIMA monotherapy. For the Study 201 in combination of 7386 and the KEYTRUDA, dose confirmation part was completed as well. E7386 action on CBP and beta-catenin, which play very important role in the Wnt signal and deeply involved in the resistance to IO therapy. As you see in this slide, the TMB, tumor mutation burden, and PD-L1, two biomarkers are analyzed based upon the public TCGA datasets for 29 types of cancer with a total number of patients of 9,218 people to conduct a biomarker analysis.
As you can see, pale gray and a dark gray represent a PD-L1 low and a TMB low IO-resistant cancer. Out of this, about half, 46%, had shown high Wnt signal activity across cancer types in dark gray population. That is where I'm talking about E7386 in combination with KEYTRUDA has shown the great potential to have high potential to overcome IO-resistant cancers with high unmet medical needs. In this Study 201, phase II part was initiated in order to target melanoma second line and IO-resistant ones, and HCC second line, and the NSCLC third line microsatellite stable ones. We are trying to achieve the clinical study for the triplet E7386 and LENVIMA/KEYTRUDA, which is currently under consideration.
This is the last slide from me. Regarding oncology pipeline, we are promoting a materialization of optimal modality by unique chemistry capability with breakthrough drug discovery hypothesis toward the refractory cancers based upon deep human biology learning. On top of what we've explained, based on in-house payload strategy, we are working for the new ADC platform. For the preclinical late phase, new asset is what you can see toward the bottom. The currently what is quite collecting attention as a new blockbuster is the ADC using protein degrader as payload. This is what we are working for. With this, you can target undruggable target. Also another one that is also paying more importance on is messenger RNA targeting splicing modulator used as a payload that neoantigen inducer.
That is also what we are working for the joint collaboration. Post LENVIMA, that is also well prepared for us. With this, I would like to close my part. Now Yasuno is going to speak from here.
Thank you. Here. Yes. Now myself is going to report on the consolidated financial forecast for full-year in FY 2022. Also this is mid to long term, but I'd like to talk about capital and the dividend policies toward FY 2030 and our SDG initiatives. First of all, there was no revisions to the consolidated earnings forecast disclosed on June 8th. We will implement efficient operations with the priority given to advancing lecanemab. Next, I would like to talk about our capital and dividend policy toward FY 2030.
Today, Ivan and Owa explained lecanemab, the subsequent AD pipeline, LENVIMA, MORAb-202, and E7386, as well as subsequent oncology pipelines. As you all understand, the potentials of these pipelines are enormous, and we have strong confidence in these projects. We are aiming for a rapid increase in revenue in FY 2030 led by the success of these new products. As indicated in the blue box, we will aim to realize hhc eco with a standard loan model through strengthening financial robustness and increasing flexibility for investment. We currently have a very strong balance sheet, but our investments will be focused on our in-house pipeline and business development, including digital area. Our simulation shows that expecting equity capital to accumulate to over JPY 1 trillion and equity ratio to reach to 70% level with net D/E -0.3 to +0.3 level.
We are aiming to maximize the shareholder value through unprecedented rapid growth. Regarding dividends, based on the strong balance sheet, we will manage equity ratio and net D/E through a dividend increase in continuous and timely manner. Dividend policy is to return 8% of the cost of equity by cash. However, the DOE level may increase to maximize the shareholder value. We aim to raise DOE to 15% level and ROE to 25% level in FY 2030 through rapid growth mainly given by in-house pipeline, in addition to increasing dividends supported by the strong balance sheet. Next, please. In addition to the above, efforts to enhance corporate value from financial perspective, we are also working to enhance our corporate value through the achievement of SDGs based on our philosophy based on management.
In 2012, Eisai was the only Japanese company to participate in the London Declaration on Neglected Tropical Diseases. 10 years later, in June of this year, we signed the Kigali Declaration, the successor to the London Declaration. Since 2013, we have been manufacturing DEC tablets medicine for lymphatic filariasis at our plant in Vizag, India, and have supplied 2.05 billion tablets to 29 countries through WHO. Through this program, diseases have been eliminated in 70 countries, and the number of the people infected has been reduced by 74%. 860 million people are still at risk of infection.
Eisai will continue to provide DEC tablets at price zero until elimination of the disease is achieved with an aim to realize the social good with efficiency by relieving anxiety over health and reducing health disparities. In closing, let me summarize. Under the HHC concept, we aim for rapid growth through the expansion of in-house developed products as an innovation company originated from Japan. Aiming for lecanemab's success while achieving solid growth in LENVIMA and bolstering post-LENVIMA products. We'll maintain an optimal capital structure to support business expansion while aiming for investors' return through achieving the highest ever ROE and DOE. We aim to effectively realize social good. I would like to ask for your continued support. That's all. Thank you very much.
With this, I would like to open the floor for Q&A. If you have any questions, please press the button asterisks one, star mark plus one. We are going to receive questions from the participants. Please wait for a while. Now, the first person to ask a question is from Nomura Securities, Mr. Kohtani. Mr. Kohtani, do you hear me?
This is Kohtani of Nomura Securities. Do you hear me?
Yes. Please ask your questions.
There are two questions about oncology. First, for LENVIMA, LEAP-002 study was a failure. Sorry, JPY 500 billion in the annual target of the sales should be withdrawn. But with a positive note, I think that LENVIMA is for HCC, and it was very efficacious as the comparator.
006 study looked at in LEAP program, and in the comparator was the KEYTRUDA plus, the ALIMTA and, the combination therapy. This is the global therapy, and I think that this global standard therapy, so it will be very hard. LEAP-007 with an NSCLC alone, do you think that there is a likelihood to achieve the significant difference? KEYTRUDA plus LENVIMA in LEAP-006 without platinum and there was no significant difference, so why are you able to say that you are confident? LEAP-005, this is for second line, therefore we can have expectation. If LEAP-005 alone can be successful, and then what will be your projection of the peak sales of LENVIMA? That is my first question.
Regarding this question, Dr. Owa is going to respond.
Thank you very much for your question, Mr. Kohtani. First, LEAP-002 study. HCC is the target indication. The detail will be presented at academic society. Very strong data will become available. Over 700 cases in a phase III study. The LENVIMA monotherapy power, how powerful the LENVIMA monotherapy can be. That has been the new finding in this study. Oral administration monotherapy and in this area, the antibody combination therapy is being tried. But for the easiness of use for patients and also health economics benefits, considering all these factors, LENVIMA monotherapy HCC first line treatment value has been actually enhanced based on the data that has become available recently. This is not our hope, but we have made such analysis. Next, for lung cancer.
As you pointed out, Mr. Kohtani, I would like to correct the number of the study. LEAP-007, this is for the first-line lung cancer. You said that we failed in the study. As you know, PD-L1 positive patients were the target population. The squamous cell carcinoma, non-squamous cell carcinoma, both were included. For LENVIMA, it was most disadvantageous population for LENVIMA. PD-L1 positive patients were targeted, so this is in contrast to LEAP-002. KEYTRUDA was strong in this population, and it was difficult for LENVIMA to ensure the significant difference. The squamous cell carcinoma was included. Avastin is not approved. There is the hemoptysis or bleeding risk. Adjustments had to be made. LEAP-007 and LEAP-006 cannot be compared head to head.
006 in LEAP program was based on the disadvantageous condition, excluding the squamous cell carcinoma. Only non-squamous cell carcinoma. All comers were tested. In this population, lung cancer, FGFR dependency is high. Particularly for LENVIMA, ORR safety run-in part, 70% of ORR was observed. The usual 50% or so ALIMTA cisplatin and KEYTRUDA combination, only 50% level was reported, and it was outstandingly higher level. We do not have any doubt in activity. In add-on study, we expect that there will be a certain level of results. Regarding LEAP-008, as you said, it has a very large potential. As you know, in many first-line treatment with KEYTRUDA, even in earlier line, like adjuvant and maintenance therapies are indicated. Second line, it may become first line.
That means that what is available in second line may be moved up. Even if we, when we say second line, the potential is great. LEAP-006, LEAP-008, of course, we believe that there will be a positive results coming from these studies. Considering the value in the original market, I think that there is a potential to see further values generated. That is our stance.
Thank you very much. My second question. I was concerned on protein degrader payload ADC for pancreatic cancer undruggable targets on page 15. KRAS G12D is mentioned. Protein degrader is also utilized by others. University of Glasgow has been the partner for you. In protein degrader, I think you have been well-versed in protein degrader area. Could you please elaborate on what you know?
Thank you. Protein degrader, not only in Japan, but also in terms of the world, there has been a lot of accumulation of technology and know-hows, since many years ago. Collaborating with University of York and University of Dundee in Scotland, in research and, utilizing expertise of each academic centers have been introduced. KRAS was touched upon in your question. I'm not able to answer on that part. Such cancer, big four undruggable targets are being aggressively targeted. The protein degrader, it has the potential to do that. We will file for the application of the patent, and I will be able to introduce, some more information to you. I would like to refrain from referring to further. Thank you very much.
Next, question, Citigroup Securities, Mr. Yamaguchi, please. Mr. Yamaguchi, can you hear me?
Yes, we can hear you.
Now please start.
The first question is about the progress of the performance. Thank you very much for such a clear explanation. The remaining is the KEYTRUDA-related milestones and the strategic options. I think that you are going to come up with something with that regards. You know, we are in Q1 currently, but for Q2, Q3, Q4 milestone distributions, could you explain that? If you have a certain idea about that, it would be useful for the forecast of the quarterly approach for us.
Tatsuyuki Yasuno is going to answer for that.
Tatsuyuki Yasuno speaking. Mr. Yamaguchi, thank you very much for your explanation. The quarterly profit progress level and plan or forecast is for your question, I believe. full-year forecast. The high probability strategic options are included. However, the timing of that happening is something I rather refrain myself from talking about. Toward the end of the fiscal year in a staggered manner, it's likely to increase. Please understand it that way. Thank you very much.
Thank you.
Which means rather than Q2, Q3 and afterwards, rather than first half, it'll be more in the second half that you will approach for that. You can understand it in that way. Thank you very much.
Thank you. Second question, that is about page 15. You have several ADC new projects explained. I would like to know your approach for your ADC. The payload is going to be changed one by one. Linker, putting aside antibody, but linkers, those are designed individually and some are degradable, some not. Including those, you have a bit different approach for ADC. Also, splicing modulator, you work for BMS, and that is already available, as information or, already on the market or for the information, or you have already started the joint research. Who is going to answer for that?
Mr. Yamaguchi, thank you very much for your question. First of all, ADC. Our approach for ADC as a whole, first of all, to the antigen selection. The selection against the antigens or the cancer rather, is going to be enhanced as much as possible so that the specificity is going to be enhanced and side effects, adverse events are reduced. Linkers, already we have a very strong capability for chemistry. Next generation ADC, it has the original linker and payload.
Well, so far we have seen many of such with the cytotoxicity, but it's not the simple cytotoxicity, but our uniqueness. In other words, other companies cannot develop. Such kind of payload is what we would like to utilize. Splicing modulator BMS collaboration, we are still in the preclinical, but we have an agreement for the collaboration. We have distributed roles to work for this. We will work for this together with BMS so that it can get into the clinical phase. That is the current status. Thank you very much.
Thank you so much. The ILD for those this year or next year, would you explain about that?
Of course, earlier is better, but we are aiming at next year as a target. At this moment, this is just what we hope. We would like to make it as early as possible. That's all. Thank you very much.
Next, from JPMorgan Securities, Mr. Wakao. Mr. Wakao, please ask your questions.
This is Wakao of JPMorgan. My first question is about LENVIMA. On page four, you introduced the first quarter progress in LENVIMA, which was quite good. From second quarter onward, do you think that this trend will continue? I think that the progress rate is quite high. Have there been any extraordinary factors for increasing the progress in the first quarter?
Mr. Yasuno is going to respond.
This is Yasuno speaking. Thank you very much for your question, Mr. Wakao. As I introduced today, LENVIMA's results during the first quarter was quite steady and very strong growth was observed in all regions. As you asked in your question regarding China, even after the entry of generic, we have maintained a very high share in the market there. When it comes to the second half. Excuse me. There will be a intensive purchasing program by the government. In that category of program, there has been the impacts of this omission from this government program. Therefore, towards the second half, we believe that the weaker results will be shown. In the United States and Europe and Japan, indications have been expanded.
In these regions, we believe that we are continuing to grow our share in the markets. We believe that there is a high probability of achieving the annual target for this fiscal year. Thank you.
Thank you very much. My second question is about lecanemab. In September, primary endpoint readout is expected. The timing for us to know the result. Can we expect that that will be available by the end of September or in early October? The information has continued to be updated, and the dropout rate seems to be slightly increasing. If that is contained below 20%, do you think that we don't have to think it as a problem over the time in progress in the study? Do you think that there will be no likelihood of seeing increasing dropout rate?
Thank you very much for your question. Ivan Cheung is going to respond.
Thank you very much for your question. This is Ivan Cheung. To your first question, as I explained earlier, the top line results for Clarity AD will be around the end of September. Please rest assured that we will make an appropriate announcement in a timely manner in that regard. To your second question about the dropout rate, right now is approximately 15%, 15%. As you know very well, in these phase III trials, usually around 20%-25%. We have been doing very, very well. As you know, we are now in early August. The top line readout will be end of September. We actually just have not that many patients left to complete the last month of treatment. This 15% will most likely, not probably, most likely stay around this number. We have no concern whatsoever. Thank you.
Are you satisfied with the answer, Mr. Wakao?
Yes, thank you very much.
Next question, Credit Suisse Securities, Mr. Sakai, please.
Sakai is speaking here. First of all, LEAP-002 study, you can get some learnings from the failure. I understand that logic. At the same time, on the other hand, this fiscal year, I think it is incorporated into the milestone already. What do you think about that point?
With that question, Chief Planning Officer, Ujiie is going to answer.
Thank you for the question. full-year forecast has the strategic options with a high probability and each individual details of those. Well, rather, we would like to refrain ourselves from disclosing such details. That's all.
Is that okay, Mr. Sakai?
In that case, I have two more questions. One question is to Mr. Owa. This is for splicing modulator with ADC this time. It's H3B-8800, I think H3 Biomedicine.
That's what you licensed out, splicing modulator, I think that was it. With this regard, I believe you are working on the collaborative development with the BMS. This splicing modulator is currently gaining attention. What's your strategy? What's the relationship of that one with this new ADC you are talking about?
Takashi Owa is going to answer for Mr. Sakai.
Mr. Sakai, thank you for your question. The splicing modulator hypothesis of the drug discovery covers wide range. There are three main pillars, and each has potential, I believe. First of all, licensing out to Roivant. This is about the hematologic cancer, and we don't have a franchise in that. With Roivant, we've established a new Hemavant company and within the hematology, the reduction of the blood transfusion is what we are working for.
This is quite unique and this is the clinically recognized endpoint. This is where we would like to work for. With this regard, we thought the partner is quite appropriate, so we decided to license out. For this ADC, while actually splicing targeting messenger RNA and a neoepitope or neoantigens are generated and immune cold is then converted into immune hot. This hypothesis is completely different. Who would be the appropriate partner? Well, needless the giant of immune checkpoint inhibitor BMS. With BMS, we are working for the joint strategy. Each has the strategic perspective and there is no contract was overlapping. We have a clear differentiation there. That's all.
Mr. Sakai, is that fine with you?
Yes, one more question. Dr. Owa, I think you have already finished the rolling submission. December is likely to be the full package submission, and I believe your response is that you are going to wait for that. For the rolling submission when it is completed, it will be communicated as news, and there'll be no further FDA action initiated. Is that understanding right?
With regards to this, Ivan Cheung is going to answer.
Thank you for your question. The rolling BLA submission under the accelerated approval pathway was already completed back in May. The FDA accepted our rolling BLA completed filing and gave us the priority review with the PDUFA action date on January 6th. This is the accelerated approval application. Our plan is upon receiving the accelerated approval, we will then immediately submit the sBLA, supplemental BLA, that will contain the additional information of Clarity AD results to gain full approval from the FDA. We continue to believe Eisai is well ahead of other companies in securing the first-in-class first full approval from the FDA of an AD-DMT, in this case, with lecanemab. Thank you.
Mr. Sakai, are you satisfied with this answer?
Yes.
Okay, thank you very much. We have received another question from Jefferies Japan, Stephen Barker. Stephen Barker, please start asking your question.
Stephen Barker of Jefferies. Thank you. License revenue, I have a question. In the annual forecast for the revenue, how much has been incorporated in your forecast? Could you please tell me?
Regarding that question, Mr. Ujiie is going to answer.
Thank you for your question. For this fiscal year, license revenue. Your question was about license revenue. In the full-year forecast, in other income, JPY 73.5 billion and JPY 13.5 billion n other revenue. With a high probability, cases are included in our forecast. Regarding more further specifics, we'd like to refrain from mentioning them.
Considering the materials of Merck, the $300 million as sales milestone for LENVIMA is to be paid to you. Is this the same understanding within Eisai as well?
Regarding this question, Mr. Ujiie is going to respond.
Thank you for your question. Right. $300 million, according to the disclosure of Merck as milestone payment, we have not taken into account the details of that number. I mean, we are not disclosing the specifics on the numbers.
Understood. According to the same set of materials, going forward, what should be paid $300 million milestone above that, there is no plan to pay other than this. That is mentioned in the material by Merck because according to the perspectives of Merck, $300 million as milestone will the limit that they are going to pay, so there is no need for paying further than that. They do not plan to pay further. That means during this fiscal year, this may be the last payment by the end of this fiscal year. How do you think?
Mr. Ujiie is going to respond to your question.
Thank you for your question. We don't think that is the case. At the time of signing the contract, $6 billion, which was announced at the time of signing the contract, we still have the residual portion. In line with the growth of LENVIMA, we believe that there are still opportunities for receiving the benefits. JPY 500 billion in revenue, if that is achieved, then you expect that there will be milestones to be paid. It really depends on how much growth you can make in the revenue.
Right. There is one more person to ask question here. We are already after the time that we're supposed to close. Here is the last. Tokai Tokyo Research Center, Mr. Akahane, please. Can you hear me?
I switched the phone, so sorry about this inconvenience. The simple question that I have, in the first quarter settlement, it is not that good, but as has been explained, moreover, if JPY 49.6 billion is deducted, it is quite on track. Forex, JPY 6.28 billion negative, and that is excluded, then you can see the true sense of the revenue from pharmaceutical business. Is this understanding right?
Yasuno is going to answer.
Yasuno speaking. Mr. Akahane, thank you very much for the question. Yes, your understanding is right. Thank you very much.
Also regarding forecast, in the supplement material, you have the forecast rate and term and the forecast. Here is the yen positive, that Forex rate. Well, actually, that is a profit larger in U.S. dollars, so here it's a negative. What's the impact of that for the full-year plan? You have the JPY 10 million of the inventory. Does that have the impact onto the inventory for you?
Sorry, Yasuno is going to answer for that question. Thank you for the question. Yasuno is going to answer for it.
The full-year forecast, currently, as has been pointed out, the Forex rate, the volatility for that is quite high, so it's very difficult to see clearly toward the future. The impact onto the revenue or onto the profit comprehensively considered, we believe we can achieve the current forecast. Again, Forex impact, as you pointed out, they might have the impact onto different areas, but considering all those factors as well, we are aiming for achieving the forecast.
Mr. Akahane, is that fine with you?
Yes. Thank you very much.
Okay. With this, we would like to close the financial results announcement. If you have additional questions, please contact with IR/PR. Here, we would like to close today's meeting. Thank you very much for your participation.