It is now time. We would like to begin financial results presentation for the second quarter fiscal 2020 by Eisai Co., Ltd. The presentation will be live-streamed or it can be heard on telephone lines. Those who are participating on the telephone lines, please refer to the deck of slides that are uploaded on the website of Eisai, download them, and click them yourselves. Let me introduce the presenter today. Presenter is Representative Director and CEO, Haruo Naito. Now, without further ado, presentation will begin.
I would like to start the presentation on the financial results for the second quarter of fiscal year 2020. On this slide, we are showing the consolidated statement income for the first half. As you can see in the headline, during the period under review, there were impacts of COVID-19 pandemic globally. It's not an exaggeration to say that. Given these circumstances, the top line revenue was JPY 317 billion, up 6% year-on-year. We achieved increased revenue. Cost of sales ratio was 25.1%, an improve of about 2.7 percentage points from a year earlier. This is mainly due to the improved product mix because of the expansion of in-house developed products. Gross profit was increased by double-digit ratio from a year earlier, and the gross margin ratio was improved by 2.7 percentage points. It has demonstrated a sound, robust foundation for profit generation.
R&D expenses. In our case, we receive partners reimbursement. Including those reimbursement from partners, R&D expenses account for 30.7%. Among global peers, we are one of the companies which are allocating significantly into the R&D activities among the management resources. Oncology, Neurology have been the two major areas where we have significantly allocated our resources. SG&A expenses have expanded by about 1.9 percentage points in terms of ratio in the revenue. I would like to touch upon this later, all of these expenditures were to capture the existing business opportunities or future business opportunities. To capture them, we have allocated resources. These have been the proactive investments for future growth. As a result, operating profit was JPY 34.1 billion, up 6% year-on-year. Profit for the period was JPY 25.8 billion. ROE was 7.6%, although this was the interim number.
At the board of directors meeting held today, we resolved interim dividend of JPY 80 per share. Next slide. Here, we are showing the breakdown of migration in revenue. On the left-hand side, you see the actual result for the last fiscal year, JPY 299.3 billion. In each region, you see the status of changes in revenue. In Japan business, minus JPY 6.2 billion in revenue. The number of products designated for premium to promote the development of new drugs has increased. Because of the factors for decrease of revision of drug prices and the impact of COVID-19 negatively affected the business. In Americas, there was a strong growth of LENVIMA, though BACE was discontinued. Although there were also negative impacts of COVID-19, all these factors were overcome to grow by JPY 9.6 billion in Americas. China business.
During the first quarter, we believe there was significant impact of COVID-19, but during the second quarter, that impact was overcome and made up for, and there was an upside of about JPY 1.3 billion for the total first half. Turning to Europe. Even now, it has been affected significantly by the second wave of COVID-19 pandemic in this region. Given the strong growth of LENVIMA, we have had the upside of a positive JPY 0.8 billion. In Asia and Latin America business, mainly due to the termination of sales contract of HUMIRA in Taiwan. The revenue was reduced by JPY 1.3 billion. COVID-19 impact is estimated to be about 5% of the revenue. In the bottom right corner, you see the plus and minus in global brands. LENVIMA has shown very robust growth as a result. Revenue increased by JPY 17.8 billion year-on-year.
Of course, this increase included one-time event, which was the transfer of rights for tazemetostat. There was the revenue received for that. One-time event had an impact of JPY 13.5 billion in increase to the revenue. I would like to share with you the breakdown of operating profit migration. From the left, JPY 32 billion was recorded as operating profit for the last fiscal year. Next to it, global brands expanded to contribute JPY 18.3 billion, which had shown a strong expansion. Following four items are to capture the immediately available business opportunities or upcoming or future business opportunities to be captured by making these resource investments.
In July, Japan and in June in the U.S., DAYVIGO was launched and related costs for the DAYVIGO launch were incurred, and R&D costs for LENVIMA, and the shared profits with partner has increased in line with the expansion of LENVIMA. To capture the future opportunities in Alzheimer's disease franchise costs related to AD, we made these investments. On the right-hand side, our one-time event contribution to the increase in operating profit is shown. As a result, all in all, there was an increase of operating profit by JPY 2.1 billion year-on-year. At the far right, you can see the status of R&D expenses. As I said earlier, we receive reimbursement from partners, which is shown in yellow part. Overall, total R&D expenses seem to have decreased, but this is mainly due to the termination of the elenbecestat project, BACE inhibitor project last fiscal year.
This was the main reason for the decrease. Turning to the business. First, we'd like to share with you our initiatives related to COVID-19 pandemic. In the top half of this slide, we'd like to report to you what we are doing about treatments. First, eritoran. We used to develop this as a candidate treatment for severe sepsis. We reached the phase III study, however, could not meet the endpoint, so this was the theme of development. This eritoran is antagonist for Toll-like receptor 4, which is at the most upstream of various cytokine gene expression signaling. The COVID-19-associated pneumonia and cytokine storm is thought to be the cause for such pneumonia, and this is expected to stop a cytokine storm at the very upstream. This had been developed till phase III. Therefore, the safety profile for this candidate has been completed.
This is now being developed under the international consortium called REMAP-COVID. Clinical research studies have been started and actual administration in patients have started. E6011, which was discovered by a current research institute as anti-fractalkine monoclonal antibody. Angiopathy is known to be the frequently observed symptom of COVID-19 infection. It is expected to be effective in tackling this. This has been adopted by AMED. It is being considered to be introduced into clinical trial. In bottom left, development of treatment agents. A screening utilizing chemical library under the scheme of Bill & Melinda Gates Foundation. Our unique naturally derived compound library has been provided to this scheme, with several potential candidates identified. In bottom right, there is a collaboration for the development of vaccines. Our former Boston research laboratories have succeeded in discovering adjuvant to vaccine.
Utilizing this adjuvant, the COVID-19 vaccine research is being conducted by Canadian company, VBI Vaccines, and we understand that clinical study discussion is underway. Next, I would like to talk about clinical stage pipeline for AD. Today's Eisai, the drug development and the discovery for Alzheimer's disease is based upon this scheme. At the top, on the horizontal axis, AD continuum. This is the continuum of disease progression in Alzheimer's disease, which is shown in the horizontal axis. On the vertical axis, ATN and pathophysiological hypothesis is shown. This is hypothesis of pathophysiology. Based upon these two axes and the domains, we are implementing drug creation. Preclinical AD, early AD, and AD are included in the AD continuum. Like this disease is expected to progress. Early disease and amyloid aggregates on the vertical axis. The domain covered by this aducanumab is positioned here, anti-amyloid beta antibody. Preclinical AD.
If you go back to preclinical AD in AD continuum, you see BAN2401, or that is named under INN as lecanemab, which is positioned here. Anti-amyloid beta protofibrils antibody. ATN-T, T in the ATN, tauopathy. Of course, this project is covering the entire ATN. Particularly for this tau, our in-house developed anti-tau antibody E2814, for which phase I study is ongoing. NXN, neurodegeneration. In the domain covered by this here, first-in-class synapse regenerate. Synapse regeneration is expected to be the efficacy. In-house small molecule compound of E2511. Phase I study has been initiated. This E2511 is targeting early AD and later stages of AD continuum. We expect that this will be efficacious in addressing these stages. At the bottom, dementia with Lewy bodies, which is set to account for about 20% of all dementia.
The drug creation is shown here. Cyclic GMP is expected to be reduced, and that has been confirmed based on the human biology. PDE9, which is associated with the cyclic GMP. By inhibiting this, it is aimed at maintaining cyclic GMP level. That is the pharmacological effect. E2027 is now in the phase II/III study, which is ongoing. First, for aducanumab, as has been already announced in the United States, the application has been filed with FDA, and it has been granted a priority review with a PDUFA action date set on March 7, 2021. It may be granted the expedited review for this BLA. Actually, this advisory committee meeting will be held tomorrow, where discussion will be conducted. In Europe, for EMA, marketing authorization application has been accepted by EMA, and we believe that the review is underway.
With PMDA, pre-submission formal consultation meeting was held, and we are preparing for NDA in Japan. With other additional key markets, we have started preliminary consultation discussions with regulatory authorities. Next, anti-amyloid beta protofibrils antibody, lecanemab. For your information, L is taken from the name of Professor Lannfelt, Uppsala University in Sweden. E is from Eisai, and CA is from creation. This is how this candidate has been named lecanemab. For early AD patients, regulatory trial phase III study Clarity AD. Although some sites were affected by COVID-19 pandemic, but most of those sites have resumed the study. The home infusion is utilized instead of the infusion at the hospital or utilizing the telemedicine. We have tried to minimize the delay. Completion of patient enrollment and the final readout of primary endpoints are as planned.
We estimate that these will be completed by the end of 2Q of FY 2022. This has stayed unchanged. Targeting patients with preclinical AD, phase III study AHEAD 3-45, through collaboration with ACTC. In addition to the U.S., but in Japan, Singapore, Australia, and Europe, we plan to initiate the study in over 100 sites. In the United States, first infusion has been achieved already. lecanemab, as I said earlier, is positioned in the upstream to cover up to early AD in the AD continuum. That is how we are going to position this drug in development. Novel anti-MTBR tau antibody, which is related to the tau in the hypothesis E2814. Currently, phase I study is steadily ongoing. Although it is very busy slide, I am sorry about this, in the top left corner, you see tau protein horizontally from N-terminal to C-terminal.
This is tau protein. There are various binding sites, and various anti-tau antibodies targeting various binding sites of the tau protein are being developed. Our E2814, as you can see in the red part, microtubule binding region, MTBR, is specifically engaged by this antibody, E2814. This MTBR, what does it stand for, and what is it? That is represented in the schema below. Tau is propagating through synaptic cleft. Tau fragments associated with the propagation is MTBR, in our understanding. Therefore, these antibodies are associated with the trapping of the taus in the synaptic cleft, which are associated with the propagation. Therefore, neurofibrillary tangles, NFT, can be prevented or reduced because this is thought to be caused by this propagation of tau. On the right-hand side, as human biological evidence, various in-brain tau peptides are shown. What is shown in red are related to patients with AD.
On the tau fragments which are reported to be increasing in the patients with AD are these MTBRs. In AD patients, based on human biology evidence, MTBR, which is associated with propagation, should be reduced in order to mitigate the tauopathy. This is expectation we have for this antibody. This is the in-house developed novel synapse regenerate E2511. Currently, phase I study has been initiated. In AD continuum, if you look at the schema, on top half of the schema, on the right-hand side, cholinergic neurons are significantly vulnerable in AD and known to be causing the synaptic degeneration or damage. As you can see in the schema for functional neuron, TrkA is expressed here. However, it is known that significant decrease of expression TrkA is happening, and therefore, the degenerative changes are taking place.
E2511, as you see in the third bullet, E2511 binds to this TrkA and turns on the survival and signal synapse regeneration of cholinergic neurons, and it is expected to enhance restoration of damaged neuron. These damages of the neuron will be reversed back to the left on the schema. As you can see, potentially it is expected to suppress brain atrophy caused by neural degeneration. We are expecting these effects will be exhibited by this small molecule compound. We aim to develop new concept of synapse regeneration in the development of AD therapies. We have very high expectation to this new candidate. Now, changing the subject to LENVIMA. This year's forecast is JPY 158 billion. To achieve this target, we are making good progress. On the left side, there is a bar graph describing the first half performance of LENVIMA.
In all of the five regions, growth was achieved. 136% or 36% year-on-year growth was achieved, with a revenue of JPY 68.5 billion. On the right side, performance by region is given. Central role is played by the biggest market, Americas. Revenue was JPY 41.9 billion. Growth was 48% year-on-year. A very strong growth was recorded. Regarding Americas, I will discuss in more detail. We are maintaining number one share in HCC, and indication for endometrial carcinoma was obtained. There were various upside events driving the growth in Americas. Turning to China, growth of close to 30% was seen in HCC. We have introduced new patient assistance program to reduce out-of-pocket burden. China market is growing. As for EMEA, although impacted by COVID-19, countries of where the drug is indicated is increasing.
In order to prevent infection, oral drug for cancer treatment is recommended, and we were able to achieve close to 30% growth year-on-year, and we are maintaining high share in HCC and EC. As for Asia and Latin America, Asia HCC experts gathered in APPLE, where consensus guideline discussed HCC, recommending LENVIMA strongly. For endometrial cancer, combination therapy with KEYTRUDA is expanded in a number of Asian countries.
With approval from a number of Asian countries. We would like to make sure to achieve the annual target of JPY 158 billion. Turning to the important market for LENVIMA, which is the U.S. For endometrial cancer, hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid cancer, for these four cancer types, LENVIMA is indicated. At right top, call number situation is given, including in-person and digital calls. April, May, and June, because of the impact of the pandemic, situation was very difficult. Including face-to-face calls, it is now on the recovery trend. Starting from October this year, with Merck, regarding EC and HCC, our efforts will be enhanced to increase call level back to pre-COVID level. We have reached agreement with Merck on this, for EC and HCC, we are sure that we will be able to make further progress.
At right bottom, for each cancer type, revenue ratio by indication is given. Endometrial cancer was added in the first half of this year. Regarding RCC, there is a benefit of reducing the infection by using oral cancer drug. For DTC, we are maintaining share. Regarding LENVIMA, in fiscal 2025, JPY 500 billion level is the target. LENVIMA KEYTRUDA combination therapy. LEAP studies are underway to contribute to additional indications. Currently, there are 11 studies ongoing as shown here for submission purposes, conducted as randomized control studies. In the middle of this slide towards left, what we plan to prove usefulness for is shown, and the number of new patients for these cancers are shown. For each of the cancer type, large number of newly diagnosed patients exist each year. Lung cancer, hepatic cancer, bladder cancer, kidney cancer, endometrial cancer, head and neck cancer, and melanoma.
For each of the cancer type, phase III study is underway. There are three RCC, two HCC, and two EC studies. Sorry, three NSCLC study, two HCC study, one RCC study, and two EC studies. Basket trial on mostly solid tumor has yielded good results, which was presented at ESMO 2020. Of that, I would like to report further on NSCLC. For systemic treatment-naive patient, LEAP-006 study was conducted. In the safety run-in part, 13 subjects were enrolled with a response rate of 69%. We were able to obtain very robust result. This was presented at ESMO 2020. In the main part of the study, in the comparative control part, we are making good progress in enrolling patients.
In addition, in LEAP-007 study, first-line PD-L1 positive study, and in LEAP-008 study, in the second-line study, in these studies as well, we are also making good progress in enrolling patients. This major cancer type, lung cancer, is also an area where we are making efforts to make contribution. On this slide, basket trial details are given. Colorectal cancer, gastric cancer, ovarian cancer. In the late-line refractory cancer types, trials are conducted and the favorable results are expected. We would like to expand the number of subjects to further our research. Now, I would like to change gears to discuss structural reform in the regions. First, turning to Japan, within Eisai Japan, deputy president was named. HX Headquarters and ADF Promotional Headquarters are established under the deputy president. HX Headquarters stands for Healthcare Professional Engagement Transformation Headquarters.
Digital will be thoroughly utilized to provide various information to medical professionals and to engage in closer exchange with medical professionals. Under this headquarters, there are a number of departments starting from Digital Solution Department, and as shown in the small blue points, patient information will be received, and that information will be processed together with our data to come up with useful information and daily life-related data or digital medicine like digital solution can be offered. This will grow in importance. The department responsible for these efforts was established as Digital Solution Department to introduce, plan, and promote digital solution and to build P3 model. Next is Field Force Support Department. During the COVID pandemic, there were various restraints on sales activities. Digital communication tool grew in importance as a result.
CRM, customer relationship management, is used and implemented. There are various tools and programs to support CRM implementation to enhance digital communication capabilities. That will be the responsibility of field force support department. The third is digital marketing department. These very digital tools will be utilized by this department. Rather than in-person, digitally information will be communicated to a certain group of experts. That is the digital marketing department. A real-world data marketing department was also established. Medical institutions have real-world data. We will also be engaged in analyzing and utilizing that information to generate various useful information. Koroban is a system to prevent fall. Such a system is an example of efforts by this department. At the center, ADF Promotional Headquarters. It stands for Alzheimer's Disease Franchise Promotional Headquarters. Various efforts are to be realized, including brand management. Second is value.
This group will be also engaged in Asian region pricing strategy, improvement of access, patient assistance program review. In addition, PET and CSF and future blood diagnosis dissemination will be responsibilities under this value department. The third is HAC, H area coordination. For each medical region, there will be a network built between family doctors and specialist doctors, diagnostic network and treatment network included. The network building will be the responsibility of HAC. Below, network. Eisai currently has dementia cooperation agreement with 167 partners, including with local municipalities, various efforts with these partners will be promoted by this network, including brain performance enhancement efforts and improvement to delay shift to MCI. On the right side, under Chief Digital Officer, CX headquarters was established. CX headquarters stands for consumer experience transformation headquarters.
For dementia ecosystem, we have Easiit, and Easiit will be implemented by this headquarters. We would like to expand the number of members under Easiit, and there will be personal health record input by members, including information on diet, walking, and sleeping, and such input can be made more convenient. We would like to develop IoT and other technologies for that purpose. That will be done under marketing department. Part of Easiit is a simple checking of brain performance. This is a digital tool called NouKNOW, and this is already marketed. NouKNOW can be used in insurance industry or in financial service industry, construction, retail, automotive, fitness, cosmetics, and other industries. We are collaborating with providers in these different sectors using NouKNOW. Partnership with these multi-sectoral partners will be pursued to further improve convenience of these services, and that is done under planning and partnership department.
As represented by NouKNOW and Easiit, we would like to enhance and improve our ecosystem and would like to add products and services. At right bottom, there are navy blue boxes, including Conversion Science. At the center of this ecosystem is the data. Clinical trial data, cohort data will have to be converted to be input into this ecosystem, that will be done under Conversion Science. Maintaining digital infrastructure, etc., the digital security, system security, will be the responsibility of Tech Squad. As for Easiit, that I've already explained, as you already may know, the characteristics of Easiit are shown at the very top. It is an ecosystem to link daily living domain and medical domain.
The purpose is, as shown at the very bottom in the message, to increase awareness of disease and allow for early access to consultation, and to bring about behavior modification. We would like to eliminate chasm in the daily living domain. PHR, including data on sleep, diet, and walk, will be input by people. This also will include NouKNOW information regarding the assessment of brain performance. Easiit in the daily living domain is where we have collaboration alliance with DeNA. Current health data visualization and output, and useful information to improve brain performance. In the future, we would also like to be able to provide information that will be useful in prevention of dementia onset or prediction of dementia onset.
The core part is shown in the middle, including the latest biomarker information on dementia treatment, high-quality clinical trial results, and external cohort data, together with AI algorithm. That data part is the core part. In the medical domain, from medical professionals through digital media, et cetera, various information will be input, as shown on the right, and that information will be processed. Patient information can be shown on the dashboard, treatment effects can be visualized, and side effect detection, imaging diagnosis assistance are also possible output. In Japan, in the second half of the year, even during the COVID-19 pandemic, we would like to continue to expand contribution to patients. DAYVIGO will offer new option to patients suffering from insomnia, and digital included information dissemination is underway steadily. For rheumatoid arthritis, new JAK1 treatment, Jyseleca, will be co-promoted with Gilead Sciences.
We are seizing this very important opportunity to co-promote Jyseleca in the second half of the year. In the U.S., oncology, epilepsy, insomnia, and AD are the four franchises that we are growing in the U.S. Turning to China, there are active developments in China. On the left side, there are pie charts shown to indicate the sales performance in China. Year-on-year growth is 3%, overcoming COVID pandemic impact. The blue part in the pie is expansion with global brands, which increased from 16% to 22% as a ratio of total. These global brands are as shown on the right top, LENVIMA, HALAVEN, and Fycompa, as shown on the right bottom. In China, long-term products are also as important as these global brands. Through government centralized procurement, the same long-term products are purchased.
Regarding Methycobal, we were a successful bidder in a government centralized procurement system, and Methycobal will be procured in a priority fashion by 16 provinces, improving access by patients dramatically. At the right bottom box, Benxi plant in Liaoning Province is shown in photograph. Generic product in China will have to be qualified for very stringent BE evaluation. Benxi plant's voxilaprevir passed that qualification, and we expect growth going forward. Another point about China is our partnership with JD.com, which is a very strong platform group in China. A joint venture was established with JD.com, Jingyi Weixiang Health Industry Development Limited Company, that appears in the middle as the joint venture. Dementia-related one-stop digital service platform will be built. JD.com has an excellent network and has a very strong track record in e-commerce.
Eisai also has a wealth of knowledge in Alzheimer's disease and dementia, and disease understanding can be enhanced, self-awareness can be enhanced, online clinical work can be improved, and nursing care referral will also be supported. On the malls, merchandise of various products will be possible. This is centering around China. For dementia patients and for their families, we would like to offer one-stop digital service, and we would like to take the first step in building dementia ecosystem in China. Lastly, I would like to share with you full year forecast. Leveraging expansion of LENVIMA, as shown in the headline. Towards 2025, we will be entering into the second half of EWAY, called EWAY Future, and we will be making active investments. Revenue forecast is JPY 719 billion, 3% growth year-over-year.
We will continue to grow gross profit, and we will be making active investment of resources through the use of cost of sales. As a result, operating profit forecast is JPY 88 billion. Profit for the year forecast is JPY 67 billion. ROE forecast is 9.7%. Annual dividend per share of JPY 160 is something that we have confidence achieving. With that, I would like to conclude. Thank you very much for your attention.
We would like to start the Q&A session. We would like to invite questions first from those participating through telephone conferencing system. If you wish to ask a question, please press star mark and one. I am going to name the person who is ready to ask a question. First person to ask a question is from Citigroup Securities, Mr. Yamaguchi. Mr. Yamaguchi of Citigroup, please have the floor.
This is Yamaguchi. Can you hear me?
Yes, we can.
Thank you. This is Citi's Yamaguchi. I have one question. It may be complex in my way of asking this question, regarding the FDA's advisory committee, yesterday evening, there was a briefing document published, released. In usual briefing document, typically harsh comments may be appearing. I have never read through all the documents, scientific evidence is touched upon usually. For successful study, that will be okay.
For unsuccessful studies, how are we going to combine them in order to get the data for supporting your submission? That is the discussion in the briefing document. It's very difficult to ask this. Once you saw it, towards the end of this week, there will be the voting by the advisory committee. For you, Mr. Naito, I know that you are confident, inclusive of what is happening immediately, recently. I know that you are not in a position to make comments, inclusive of the plan and progress made to date with Biogen regarding the development of aducanumab, could you please give us your take on the current status? Anything, any comment will be welcome.
Thank you very much for your question. Exactly as you pointed out, advisory committee meeting will be held tomorrow, so it is right before us. We are at such a moment, waiting for the committee. I don't think I am in a position to make any comments. Currently, we would like to refrain from making any comments now. If I may give you one comment as my personal observation, please allow me to say that. I would like to share my personal thoughts looking back at the history of new drug development in Alzheimer's disease. Aricept, our drug, was first approved in the U.S. in 1996. This was the start of the history. After that, in 2003, memantine was approved as the most recent one as regards to the approved drugs in Alzheimer's disease.
Over the past 17 years until today, there has been a long duration of blank without any new drug approved. We look forward to a good discussion at the ADCOM meeting to be held tomorrow. Regarding the clinical trials for aducanumab, there have been many patients, other stakeholders, like caregivers and clinicians, investigators. We would like to thank all those stakeholders around the world who have participated in aducanumab clinical trials. Thank you.
Thank you very much. After the voting by ADCOM, if you could share your personal thoughts once again on that occasion, I would appreciate it.
Thank you very much. Next, we have Mr. Kotani from Nomura Securities. Mr. Kotani?
Thank you very much. This is Kotani from Nomura speaking. Can you hear me?
Yes.
Aducanumab and ADCOM information I've reviewed, a biomarker, cognitive function, behavior function improvement in NPI-10, agitation, and other psychological symptoms, significant improvement was shown. Exceptionally, for spacey, what's the wording from FDA, which I also can agree. I don't think you will be able to comment on this briefing document, I would like to ask in a different way about ENGAGE study, which was a failure. This was a surprise to me. Fast progressor, because a faster progressor efficacy was not proven in high dose.
In possible and in low dose, there were only four or five, but in high dose group, there were nine fast progressors. There is only a difference of four subjects. About phase III study of BAN2401, there is only one dose. There, I don't think there is a problem of lack of dose in the ENGAGE study, but if there are unbalanced of fast progressors, same problem can occur. In phase III study of BAN2401, how are you responding to the lack of balance of faster progressors? If there are abnormal distribution, are you able to analyze, to eliminate that imbalance?
Thank you for your question. Neurology Business Group President, Ivan Cheung, will address the question.
Thank you very much. This is Ivan Cheung, Neurology Business Group. With regard to this matter, I would point out a few things for you. Number one, in the Clarity AD study, yes, there is only one dose. That's a high dose. Please remember that the Clarity AD study for BAN2401, there is no titration. It's a flat dose, high dose from the very beginning. That's point one. Point two is, if you look at the sample size power, because we only have one dose in the study, the sample size is, I would say, very robust, to ensure that we can detect the most appropriate efficacy signal, taking into consideration a number of different potential factors, including the one that you just mentioned. These are the two points I want to refer you to. Thank you very much.
Are you satisfied with the answer, Mr. Kotani?
Yes. I have second question. I'd like to ask you a question about LENVIMA. Melanoma second line, LEAP 004, LEAP 005 indication. In principle, I think that the treatment has not been established for these patients, so increasing the number of patients, and I think it will be able to file for approval. LEAP 006 study, you have obtained a very good data. Competitors IM power, Tecentriq plus Avastin, ATAS 25, OPDIVO plus Avastin. About 60% ORR has been shown in the study. The LENVIMA is utilized, and I think in terms of the side effects, you will have unfavorable position.
Regarding this question, thank you for your question. Oncology Business Group, who is in charge of science, Dr. Owa, is going to respond.
Mr. Kotani, thank you very much for your question. As you pointed out, melanoma, LEAP-004, and a basket trial in each type of cancer included in the basket trial, aiming at increasing the number of patients to be enrolled and to make data more robust in order to explore the potential of approval, we will explore them. At the same time, the endpoint is made as the endpoint in the largest scale study, comprehensively, we would like to explore the potential of getting approval, and we would like to initiate discussion with the regulatory authorities. LEAP-006, targeting the all-comer study for lung cancer. Yes. As you said, antibody medicine, Avastin. Avastin and LENVIMA are compared for HCC. The FGFR, the inhibition, it can be expected only with LENVIMA. That is shown as a significant, the inhibition by biomarkers as well.
We have understood that. Therefore, in terms of effectiveness, we will be able to differentiate against Avastin. From this preclinical data, as well as the comparison in other types of cancer with a higher response rate and longer survival period. I think that we will be able to explore these for potential approval. Thank you very much.
Next, we have Mr. Hashiguchi from Daiwa Securities. Mr. Hashiguchi?
Thank you very much. This is Hashiguchi from Daiwa Securities. Thank you for the presentation. Page four, about AD-related expense, JPY 7.4 billion decline. This is AD-related. In the first quarter, I don't think this description was given. Is this a temporary expense? Or, as shown on page 16 and page 17, to prepare for launch, because of these efforts to prepare for launch, there is going to be a continuous expense. Is the expense level, as of now, as indicated on page four? That is my first question.
Thank you for your question. CFO, Mr. Yanagi, will respond.
Thank you for your question. I am Yanagi, CFO speaking. Regarding page four, waterfall chart, AD-related expense of JPY 7.4 billion. As you correctly pointed out, for AD products that are to prepare for launch, personal cost of goods sold are all included here, and this is not a one-time special factor. Depending on the circumstances in the future, but Alzheimer's-related next generation product preparation-related costs will be incurred, and in some cases, may be incurred in accelerated fashion. This cost, I believe, will be continuously shown during the quarterly result going forward. On a consolidated or annual performance, this is also reflected. Cost of goods sold is growing at double-digit. This is an intentional increase in cost. Cost of goods sold is growing at a double-digit, and that includes this AD-related cost, and this is a very positive future investment.
Thank you for that answer. Regarding LENVIMA sales, my next question is about LENVIMA sales. The progress to date is 43% in comparison to full year plan, and the second quarter is lower than the first quarter result. What is the probability of achieving annual target? Sales milestone forecast is given on page 34. What is the probability of achieving these milestones?
Thank you for that question. Oncology Business Group President, Mr. Iike, will respond.
Mr. Hashiguchi, thank you for your question. As for annual forecast of JPY 158 billion, there is no change about this full year target, annual target. As mentioned by Mr. Naito, CEO, during the presentation, in the first quarter, we were impacted by COVID pandemic in the U.S. and other regions as well. In particular, in the U.S., we were not able to have face-to-face contact with our customers. There are speaker programs or national broadcast programs, and temporarily, they were put on hold. After summer, these programs were resumed. In the second half of the year, actively, together with Merck, we are engaged in activities. In the second quarter, especially in the U.S., for HCC in actual clinical practice, real-world evidence will be utilized based on actual clinical practice.
Since it's an oral agent, everolimus for RCC in combination with everolimus, another oral agent in RCC is also showing growth. Therefore, in the second half, we believe that we are able to fully catch up, and achieve annual target. Therefore, regarding the milestone-related revenues, we expect to achieve these milestones. With Merck, we are working as one team. Thank you for your question.
Thank you very much. With the constraint of time, we would like to entertain one last person from Morgan Stanley Securities. Mr. Muraoka, could you please have the floor? Are you ready?
This is Muraoka speaking. I'm from Morgan Stanley. As a follow-up to the question asked by Mr. Hashiguchi for LENVIMA, second quarter seems to be a little weaker. Is it because of the fluctuation of the inventory level? Were there any such specific reasons? Rather, it is just a little weaker than expectation, therefore, as you said, the various measures will be taken to increase. Could you please elaborate on that response again?
Thank you very much for your question. We'd like to ask Mr. Ike to respond.
Thank you very much for your question. Particularly during the first quarter, mainly in the U.S., newly diagnosed patients had reduced consistently or as a temporary phenomenon. That means that there was a little time lag in transitioning of the inventory into sales. The access or visit by patients to medical institutions is recovering. Therefore, I think that this will be positively working to the second half.
I have another question regarding aducanumab. After passing through the review and getting the approval, after getting through the ADCOM, if there is a need for PET and subsidies for the testing, or maybe you are coming up with the support program for tests, I know the number of sites is not enough. How are you going to have a steady ramp-up in the initial stage of launching? I do not see any answer by myself, but I don't think that the widely available diagnostics is not launched yet. What measures are you thinking about as far as possible? Could you please share with us any ideas?
Thank you for your question. I would like to call upon Neurology of Science of Neurology Business Group.
Thank you for your question. My name is Kimura. I am from Neurology Business Group. Regarding your question about PET, how we can improve the access to PET tests. We understand that that be necessary. In brain, amyloid positivity is judged by PET and CSF, and also centesis in the lumbar spine. We are thinking about this, as far as possible, PET, CSF, and PET and N access shall be increased. We are taking various measures to increase the access. Furthermore, blood. In the end, of course, PETs and CSF measurements shall be replaced by this blood testing. That's what we are expecting to see. Before that, by having blood testing, I think higher risk patients will be accessing the PET or CSF testing. It's beneficial in terms of health economics, and it is also beneficial thinking about the burden on patients.
The CSF access will be restricted. Such various measures will be taken. Those patients with higher risk