It is now time. We would like to begin financial results presentation for the Q2 fiscal introduce our next question from the company's commentary on the company's website. The presentation will be live streamed or 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 equip them yourselves.
Let me introduce the presenter today. Present our representative, Director and CEO, Haruo Naito. Now without further ado, presentation will begin.
I would like to start the presentation on the financial results 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-nineteen pandemic globally. It's not exaggeration to say that. Given these circumstances though top line revenue was 317,000,000,000 yen up 6% year on year. Achieve increased revenue.
Cost of sales ratio was 25.1 percent, an improve of about 2 point 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. As a result, gross profit increase by double digit ratio from a year earlier. And the gross margin ratio was improved by 2.7 percentage points. So it has demonstrated a sound robust foundation for profit generation.
R and D expenses. In our case, receive partners' reimbursement. Including those reimbursement from partners, R and D expenses account for 30.7%. Therefore, among global peers, we are one of the companies which are allocating significantly into the R and D activities among the management resources. Oncology, neurology have been the 2 major areas where we have significantly allocated resources.
SG and 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, but all of these expenditures were to capture the existing business opportunities or future business opportunities. To capture them, we have allocated resources. Therefore, these have been the proactive investments for future growth. As a result, operating profit was 34,100,000,000 yen, up 6% year on year.
Profit for the period was 25.8 1,000,000,000 yen ROE was 7.6 percent, although this was the interim number. And at the Board of Directors meeting held today, resolve interim dividend of 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, 299,300,000,000 yen In each region, you see the status in of changes in revenue.
In Japan Business, minus 6,200,000,000 yen in revenue. The number of products designated for premium to promote the development of new drugs has increased, however, because of the factors for decrease of division of drug prices and the impact of COVID-nineteen negatively affected the business. In Americas, there was a strong growth of LENVIMA. Be disclosed. And although there were also negative impacts of COVID-nineteen, all these factors were overcome to grow buy 9,600,000,000 yen in Americas.
China business, during the first quarter, we believe there was significant impact to COVID-nineteen. But during the Q2, that impact was overcome and made up for. And there was upside of about 1,300,000,000 yen for the total first half. Now turning to Europe. Even now, ere has been affected significantly by the 2nd wave of COVID-nineteen pandemic in this region.
But given the strong growth of LENVIMA, we have had the upside of positive 800,000,000 yen in Asia and Latin America Business, mainly due to the termination of sales contract of Humira in Taiwan. The revenue was reduced by JPY 1,300,000,000. And COVID-nineteen 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 17,800,000,000 year on year. Of course, this increase included one time event, which was the transfer of rights for Tazemetostat. There was the revenue receive for that. Onetime event had an impact of 13,500,000,000 yen in increase to the revenue. Share with you the breakdown of operating profit migration.
From the left, 32,000,000,000 yen was recorded as operating profit for the last fiscal year. And next to it, Global Brands expanded to contribute 18,300,000,000 yen which has shown a strong expansion. And following four items are to capture the immediately available business opportunities or upcoming or future business opportunities to be captured by making these resource investment. In July Japan and in June in the U. S, DayVigo was launched and related costs for the BIVIGO launch were incurred and R and D costs for LENVIMA.
And share the profits with partner has increased in line with the expansion of LENVIMA. And to capture the future opportunities in Alzheimer's disease franchise, cost related to AD. We made these investments. On the right hand side, our onetime event contribution to the increase in operating profit is shown. As a result, all in all, there was an increase of operating profit by 2,100,000,000 yen year on year.
At the far right, you can see the status of R and D expenses. As I said earlier, we received reimbursement from partners, which is shown in yellow part. Overall, total R and D expenses seem to have decreased. But this is mainly due to the elenesis that the termination of the elendicitat project, base inhibitor project last fiscal year. This was the main reason for the decrease.
Now turn to the business. First, we would like to share with you our initiatives related to COVID-nineteen pandemic. In the top half of this slide, we would like to report to you what we are doing about treatments. First, Erbitoram. We used to develop this as a candidate treatment for severe sepsis.
We reached Phase III study, however, could not meet the endpoint. So this was the theme of development. This erichoron is antagonist for toll like receptor 4, which is at the most upstream of various cytokine gene expression signaling. So the COVID-nineteen 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.
And this has been developed until Phase III. Therefore, the safety profile for this candidate has been completed. And this is now being developed under the international consortium call Remap COVID. And clinical research studies have been started and show administration in patients have started E-six thousand and eleven, which is was discovered by the KAN Research Institute as anti fracture kin monoclonal antibody. Angiopathy is known to be the frequently observed symptom of COVID-nineteen infection, and it is expected to be effective in tackling this.
And this has been adopted by Aemet and it is being considered to be introduce into clinical trial. In bottom left, development of treatment agents, screening utilizing chemical library under the scheme of Bill and Melinda Gates Foundation. Our unique naturally derived compound library has been provided to this scheme with several potential candidates identify it. In bottom right, there is a collaboration for the development of vaccines. Former Boston Research Laboratories have succeeded in discovering adjuvant to vaccine.
Utilizing this adjuvant, the COVID-nineteen vaccine research is being conducted buy Canadian company VBI Vaccines and we understand that clinical study is underway clinical study discussion is underway. Next, I would like to talk about clinical stage pipeline for AD. Today's Eisai drug development and 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, pathophysiological hypothesis, It's John.
This is
hypothesis of pathophysiology. Based upon these two axises 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. And preclinical AD, if you go back to preclinical AD in AD continuum and you see BAN2401 or that is named in under INN as lecanumab, which is positioned here, anti amyloid beta protofibrils antibody and ATN T in the IATN, tauopathy. Of course, this project is covering the entire ATN. But for particularly for this tau, our in house developed enter the antibody E2814, for which Phase I study is ongoing. And next, N, neurodegeneration.
In the domain covered by this here, first thing plus, synapse Regenerant. SNAP's regeneration is expected to be the efficacy, an in house small molecule compound of E2511. Phase 1 study have 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 and 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.
Now E-twenty 27 is now in the Phase IIIII study, which is ongoing. First, for aducanumab, as has been already announce in the United States, the application has been filed with FDA, and it has been granted a priority review with the PDUFA action date set on March 7, 2021. But it may act 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 PMTA, 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, lecanumab. For your information, L is taken from the name of Professor lumpfeld, Uppsala University in Sweden, and E is from Eisai and CA is from Creation.
This is how this candidate has been named lekanimimab. For early AD patients, regulatory trial Phase III study, CLARITY AD. Although some sites were affected by COVID-nineteen pandemic, but almost most of those sites have resumed study and the form of infusion is utilized on behalf instead of the infusion at 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. And we estimate that these will be completed by the end of Q2 of fiscal year 2022.
This has stayed unchanged. And targeting patients with preclinical AD Phase III study ahead 345 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, 1st infusion has been achieved already. Pecanumab, as I said earlier, it's 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. Next, novel anti MTBL TEL antibody, which is related to the TEL and the hypothesis E2814. Currently, Phase I study is steadily ongoing. Although it is very busy slide, I'm sorry about this, but in the top left corner, you see tau protein horizontally from N terminal to C terminal. This is tau protein.
And 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? And that is represented in the schema below.
TAO in the is propagating through synaptic cleft. And tau fragments associated with the propagation is MTBR in our understanding. Therefore, these antibodies are associated with the trapping of the tails in the synaptic cleft, which are associated with the propagation. Therefore, neurofibrillary entangled NFT can be prevented or reduced because this is thought it 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 add. And on the CAL 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 tauopathies. This is expectation we have for this antibody.
And 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 and 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. And as you can see in the schema for functional neuron, TRACWAY is expressed here. However, it is known that significant decrease of expression TRAP A is happening.
And therefore, the degenerative changes are taking place. E2511, as you see in the 3rd collect. E2511 binds to Distruc A and turns on the survival and signal of SNAP regeneration of cholinergic neurons and it is expected to enhance restoration of damaged neuron or these damages of the neuron will be reversed back to the left on the schema. And as you can see, potentially, it is expected to suppress brain atrophy caused by neurodegeneration. 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 change the subject to LENVIMA. This year's forecast is 158,000,000,000 yen to achieve this target, we are making good progress. On the left side, there is a bar graph describe the first half performance of LENVIMA. In all of the 5 regions, growth was achieved 136% or 36% year on year growth was achieved with revenue of 68,500,000,000 On the right side, performance by region is given. Central role is played by the biggest market Americas.
Revenue was 41,900,000,000 yen grow. Growth was 48% year on year and very strong growth was recorded. Regarding Americas, I will discuss in more detail. We are maintaining number 1 share in HCC and indication for endometrial carcinoma was change, 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 and China market is growing. As for EMEA, although impacted by COVID-nineteen, countries 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 NEC.
As for Asia, in Latin America, engage our HCC experts gathered in Apple, where consensus guideline discuss the HCC recommending LENVIMA strongly for endometrial cancer, combination therapy with KEYTRUDA is expanded in a number of Asian countries with approval from number of Asian countries. And we would like to make sure to achieve the annual target of JPY 158,000,000,000 Now turning to the important market for LENVIMA, which is the United States. For endometrial cancer, hepatocellular carcinoma, renal cell carcinoma and thyroid differentiated thyroid cancer. For these four cancer types, Nenvema is indicated. At right, top, call number situation is given, include in person and digital calls.
April, May June, because of the impact of the pandemic, situation was very difficult. However, including face to face calls, it is now on the recovery trend. Start in October this year with Merck. Regarding EC and HCC. Our efforts will be enhanced to increase coal level back to pre COVID level.
We have reached agreement with Mark on this. And 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. By using oral cancer drug.
And for DTC, we are maintaining share. Regarding LENVIMA, in fiscal 2025, JPY 500,000,000,000 level is the target. And then the market truda 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 our usefulness for is shown and a number of new patients for these cancers are shown. For each of the cancer type. Large number of newly diagnosed patients exist each year non cancer, hepatic cancer, bladder cancer, kidney cancer, endometrial cancer, head and neck cancer and melanoma. For each of the cancer type, Phase 3 study is underway. There are 3 RCC, 2 HCC and 2 ECC studies.
So 3 end the CLC study, 2 HCC study, 1 RCC study and 2 EC studies. Basket trial on mostly solid tumor has yielded good results, which was presented at ESMO 2020. All set, I would like to report further on NSCLC. For systemic treatment naive patient, LEAP-six 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 and 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-seven study, first line PD L1 positive study and in LEAP-eight 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, discuss the next question. I would
like to ask you
about 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 structure reform in the regions. 1st, turn to Japan.
Within Eisai Japan, Deputy President was named HX Headquarters and ADF Promotional Headquarters are established under the Deputy President. 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 bullet 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.
So department responsible for these efforts was established as a digital solution department to introduce, plan and promote digital solution and to build P3 model. Next is Field Forest 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 implement it and 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. And the third is Digital Marketing Department. These very digital tools will be utilized by this department. And rather than in person digitally, information will be communicated to a certain group of experts. That is the Digital Marketing Department.
And real world data marketing department was also established. Medical institutions have real world data and we will also be engaged in analyzing and utilizing that information to generate various useful information. Coroban is a system to prevent fall and such a system is an example of efforts by this department. At the center, ADA Promotion Headquarters stands for Alzheimer's Disease Franchise Promotion Headquarters. Various efforts are to be realized, include brand management.
2nd is value. This group will be also engage 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. In the 30th is HAC, each 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. And below network, Eisai currently has dementia cooperation agreement with 167 partners, including with local municipalities. And various efforts with these partners will be promoted by this network, including brain performance enhancement effort an improvement to delay shift to NCI.
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 EZ. And EZIT will be implemented by this headquarters. We would like to expand number of members under EZIT and there will be personal health record input by members, including information on diet, walk, 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. And part of is simple checking of brain performance. This is a digital tool called NONO and this is already marketed. NONO it 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 NONO.
Partnership with these multisectoral partners will be pursued to further improve convenience of these services. And that is under Planning and Partnership department. As represented by Nono and IZ, we would like to enhance and improve our ecosystem add products and services. At right bottom, there are navy blue boxes, include in conversion science. At the center of this ecosystem is the data, clinical trial data, cohort data.
It will have to be converted to be input into this ecosystem and that will be done under conversion science. Digital data will be developed, maintaining digital infrastructure, etcetera, and digital security, system security will be the responsibility of Tech Squad. As for EBIT that I've already explained and as you already may know, the characteristics of EBIT are as shown at the very top. It is an ecosystem to link daily living domain and medical domain. And 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. And this also will include no no information regarding the assessment of brain performance. The easy part in the daily living domain is where we have collaboration alliance with DNA.
And current health data visualization and output and useful information to improve brain performance. And 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. And the core part is, as shown in the middle, include 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. And in the medical domain from medical professionals through digital media, etcetera, various information will be input as shown on the right and that information will be processed.
And 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-nineteen pandemic, we would like to continue to expand contribution to patients. Debut Gold will offer new option to patients suffering from insomnia. And digital included information dissemination is underway steadily.
For rheumatoid arthritis, new JAK1 treatment, Giselleca will be co promoted with Filiad Sciences. We are seizing this very important opportunity to co promote Gsilica in the second half of the year. In the United States, Oncology, epilepsy, insomnia and AD are the 4 franchises that we are grow in the United States. 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. And the blue part in the pie is expansion with global brands, which increased from 16% 2% as a ratio of total. And these global brands are, as shown on the right top, Nenvima, Halvin and Fai Compa, as shown on the right bottom. In China, long term products are also as important as these global brands.
Through government centralized procurement, system long term products are purchased. Regarding the FICO ball, lever successfully lever a successful bidder in a government centralized procurement system and meet the goal of our business.
We would like to
Metokubo will be procured in a priority fashion by 16 provinces, improving access by patients dramatically. At the right bottom box, density plant in Lamin province is shown in photograph. Generate product in China will have to be qualified for very stringent BE evaluation. Bensi Plant's voxopropine pass that qualification, and we expect growth going forward. Another point about China is or another topic about China is our partnership with Jindong Group, which is a very strong platform group in China.
The joint venture was established with Jindong Group, Jinei Weijian Health Industry Development limited company that appears in the Middle East, a joint venture. Dementia related 1 stop digital service platform will be built. Jindon 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 molds. Merchandise various products will become possible.
This is centering around China. For dementia patients and for their families, offer 1 stop digital service and we would like to take the 1st step in building dementia ecosystem in China. Now lastly, I would like to share with you full year forecast. Leveraging expansion of LENVIMA as shown in the headline. And for 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 719,000,000,000, 3% growth year on year. And we will continue to grow gross profit and we will be making active investment of resources reduce the use of cost of sales. As a result, operating profit forecast is JPY 88,000,000,000. Profit for the year forecast is JPY 67,000,000,000. ROE forecast is provide a more balanced dividend.
Okay. Annual dividend per share of 100 and 60 yen 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 and A session. We would like to invite questions first from those participating through telephone conferencing system. 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 Siti Miyamaguchi. I have one question. It may be complex in my way of asking this question. But regarding the FDA's advisory committee, yesterday evening, there was a briefing document published release and in usual briefing document.
Typically, harsh comments may be appearing. I have never read through all the documents, but scientific evidence or is touched upon usually. But for successful study, that will be okay. But 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, but once you saw it. And 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, but inclusive of what is happening immediately recently, well, so I know that you are not in a position to make comments. But inclusive of the plan and progress made to date with Biogen Regarding the development of Arukanumab, 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. So we are at such a moment wait for the committee.
So I don't think I am in a position to make any comments. So currently, we would like to refrain from making any comments now. But if I may give you one comment as my personal observation, please allow me to say that. And I would like to share my personal thoughts look 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. And 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 and till today, there has been a long duration of blank without any new drug approved.
And we look forward to a good discussion at the advisory committee meeting to be held tomorrow. And 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 update it in adikanumab 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 outcome information I have reviewed and biomarker, cognitive function, behavior function improvement in MPI-ten agitation and other psychological symptoms, significant improvement was shown. And be exceptionally persuasive with the wording from FDA, which I also can agree. I don't think you will be able to comment on this briefing document. Ask in a different way about ENGAGE study, which was a failure.
And this was a surprise to me. 1st, PROGRESSOR, because of faster progressor efficacy was not proven in high dose. In placebo and in low dose, there were only 4 or 5. But in high dose group, there were 9 fast progressors. There is only a difference of 4 subjects.
And about Phase III study of ban 2,401. There is only one dose. And so there I don't think there is a problem of lack of dose in the ENGAGE study, but if there are unbalance of fast progressors, same problem can occur. In Phase III study of BAN2401, how are you responding to the lack of balance of assess. If there are abnormal distribution, are you able to analyze to eliminate that in balance.
Thank you for your question. Neurology Business Group President, Ivan Chan, will address the question.
Thank you very much. And this is Ivan,
With regard to this matter, I would point out A few things for you. Number 1, in the CLARITY AD study, Yes. There is only one dose. That's a high dose. But please remember that the CLARITY AD study for BAN2401, there is no titration.
So it's a flat dose, high dose from the very beginning. That's point 1. 0.2 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, 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. So 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, LIV004, LIV5 indication.
In principle, I think that the treatment has not been established for these patients. So increasing the number of patients and I think we will be able to file for approval. With Zozo 6 study, you have obtained very good data. Competitors in power for Tecentriq and plus ARBASTIN, ATAS 25, Opdivo plus ARBASTIN. And about 60% ORR has been shown in the studies.
So the LENVIMA is utilized. And I think in terms of the side effects, and I think you will have unfavorable position. Regarding this question. Thank you for your question. Oncology Business Group, who is in charge of science, Doctor.
Owa is respond. Mr. Kotani, thank you very much for your question. As you pointed out, melanoma, RIIB-four and Basket trial in each type of cancer included in the Basket trial and 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. And at the same time, the endpoint is made as a the endpoint in the largest scale study.
And comprehensively, we would like to explore explore the potential of getting approval, and we would like to initiate discussion with the regulatory authorities. LEAP-six, target the all comer study for lung cancer. Yes, as you said, antibody medicine, Avastin. Add Avastin and LENVIMA are compared for HHCC. And the FDR, the inhibition.
It can be expected only with LENVIMA. And that is shown as a significant, the inhibition by biomarkers as well. We have understood that. Therefore, in terms of efficaciousness, we will be able to differentiate against Avastin. And from this clinical data as well as comparison within other types of cancer with higher response rate and longer survival period, and 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 4, about add related expense, JPY 7,400,000,000 decline. This is JPY related. In the Q1, 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 a launch, because of these efforts to prepare for launch, there is going to be a continuous expense. And as of now, the expense level as indicated on Page 4. That is my first question. Thank you for your question.
CFO Mr. Yanagi will respond. Thank you for your question. I'm Yanagi, CFO, speaking. Regarding Page 4, waterfall chart, AD related expense of 7,400,000,000.
As you correctly pointed out, for AD products to prepare for launch, personnel cost, cost of goods sold RO included here. And this is not a one time special factor. And depending on the circumstances in the future, but Alzheimer related next generation product preparation related costs will be incurred and in some cases, may be incurred in accelerated fashion. So this cost, I believe, will be continuously shown on during the quarterly result going forward. On a consolidated or annual performance, this is also reflected.
So cost of goods sold is growing at double digit. This is our intentional increase in cost. Cost of goods sold is growing at double digit, and that includes this AD related cost. And this is a very positive future investment. Thank you for that answer.
Regarding ZENVIMA sales, my next question is about ZENVIMA sales. The progress to date is 43% in comparison to full year plan and the 2nd quarter is lower than the 1st quarter result. What is the probability of achieving annual target? And sales milestone forecast is given on Page 34. What is the probability of achieving these milestones?
Thank you for that question. Onkoji Business group President Mr. Iike will respond. Mr. Hashiguchi, thank you for your question.
As for annual forecast of JPY 158,000,000,000 There is no change about this full year target annual target. As mentioned by Mr. Naito, CEO during the presentation. In the Q1, we were impacted by COVID pandemic in the United States and other region as well. But in particular, in the United say, we were not able to have face to face contact with our customers.
And there are speaker programs or national broadcast programs. And temporarily they were put on hold. But after summer, these programs were resumed. And in the second half of the year, actively together with Merck, we are engaged in activities in the Q2, especially in the United States, for HCC in actual clinical practice, real world evidence will be utilized based on actual clinical practice. And since it's an oral agent, evirolimus for RCC in combination with another oral agent in RCC is also showing growth.
And therefore, in the second half, we believe that we are able to fully catch up and achieve annual target. And 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, in 2nd quarter, seems to be a little weaker. Is it because of the fluctuation of the inventory level?
Were there any such specific reasons? Or rather, it is just a little weaker than expectation. Therefore, as you said, 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. Iike to respond. Thank you very much for your question. Particularly during the Q1, mainly in the U. S.
Newly diagnosed patients have reduced consistently or as a temporary phenomenon. So that means that there was a little a 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 was positively working to the second half. I have another question regarding aducanumab.
And then after passing through the review and getting the approval, after getting through the ad.com. And if there is a need for pets and subsidies for the testing or maybe you are coming up with the support program for tests. And I know the number of sites is not enough. How are you going to have a steady ramp up in 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. And 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 up on neurology 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 test. We understand that that be necessary. And in brain amyloid positivity is judged by PET and CSF and also sentences in the lumbar spine.
And we are thinking about these. And as far as possible, PET, CSF and PET and N access shall be increased. And we are taking various measures to increase the access. And furthermore, blood in the end, of course, PET and CSF measurement shall be replaced by this blood testing. That's what we are expecting to see.
But 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 and CSF access will be restricted. So such various measures will be taken. And those patients with higher risk