Operator
In the briefing session on the financial results for Q1 fiscal 2026 of Eisai Company Limited, today this will be held in hybrid format including in-person attendees and online attendees. Presentation materials can be downloaded from the website.
I would like to introduce the speakers today: Mr. Keisuke Naito, COO and Chief Growth Officer, and Mr.
Takuya Oyama, CFO and Chief IR Officer. First, Mr.
Oyama, CFO, will present financial highlights, after which Mr. Naito, COO, will report on the overall business.
Mr. Oyama, CFO, please.
Takuya Oyama
Everyone, thank you very much for gathering to attend this session out of your busy schedule. Let me begin with financial highlights for the first quarter of fiscal year 2026.
Revenue for the first quarter of fiscal year 2026 was ¥234.3 billion, a 15.6% increase from a year earlier. The pharmaceutical business, which is our organic business, grew significantly, achieving double-digit revenue growth.
Operating profit reached ¥24.7 billion, a 19.2% increase year on year. This double-digit increase was achieved thanks to significant global growth in our major products: Lenvima, Dayvigo, and Leqembi.
Progress towards our 2026 performance forecast is steady, with revenue at 27% and operating profit at 35%. Next slide, please.
This page provides the details of consolidated financial results for the first quarter of fiscal year 2026. Revenue increased by 16% to ¥234.3 billion, driven by the growth of our pharmaceutical business, which is centered on our major products: 3L—Lenvima, Dayvigo, and Leqembi.
Cost of sales was ¥51.1 billion, and the cost of sales ratio to revenue was 21.8%. Although the cost ratio increased year on year, it was approximately controlled within the planned range through cost-reduction efforts.
As a result, gross profit reached ¥183.2 billion, up 14.5% year on year. R&D expenses increased by 12.7% to ¥43.7 billion, reflecting a proactive investment of resources in next-generation key projects.
Selling, general, and administrative expenses increased by 14.5% to 114. 14.
114.8 billion—¥114.8 billion due to increased profit-sharing expenses associated with Lenvima revenue growth and aggressive proactive investment in Leqembi. As a result, operating profit reached ¥24.7 billion, up 19.2%.
Core operating profit was ¥24.7 billion, a 13.9% increase, and profit for the period was ¥18.2 billion, up 26%. Progress towards achieving the full-year forecast is on track, with revenue at 26.5% and operating profit and core operating profit at 35.3%.
Next slide, please. This page shows the factors that increased or decreased revenue.
As shown by the second light blue bar from the left, revenue for our major products—3L: Lenvima, Dayvigo, and Leqembi—increased by ¥24.8 billion from the previous year, and revenue for our pharmaceutical business expanded by 16% to ¥230.9 billion. Revenue of products other than the 3L was also strong.
Overall revenue increased by ¥31.7 billion to ¥234.3 billion. Next slide.
This page shows the factors that caused increases or decreases in operating profit. Gross profit increased by ¥23.2 billion due to the growth of the pharmaceutical business driven by the growth of our 3L business.
R&D expenses increased by ¥4.9 billion due to continued proactive investment in key projects, such as the clinical trial of Leqembi for preclinical AD and the anti-MTBR tau antibody, E2814. SG&A expenses increased by ¥14.7 billion due to higher profit-sharing expenses associated with Lenvima revenue growth and proactive investment in Leqembi.
There are no other significant factors contributing to increases or decreases in other income and expenses. As a result of that, both operating profit and core operating profit reached ¥24.7 billion, representing significant increases in profit.
Furthermore, while we had prioritized profitability on commercial basis, this fiscal year, excluding Leqembi's R&D expenses, we posted our first ever profit in the first quarter thanks to Leqembi's strong growth, ongoing cost control, and prioritized allocation of SG&A to key markets. We will continue to work diligently towards achieving full-year commercial basis profitability.
This concludes my part. Next, our COO, Mr.
Naito, will give us an update on our business. COO Naito, please.
Keisuke Naito
From here, I will explain the recent business progress and pipeline that will support medium- to long-term growth. First, I will present business update for the three products: Lenvima, Dayvigo, and Leqembi, which are driving our growth, so-called the 3L products' business updates.
In particular, regarding Leqembi, I will explain the progress toward maximizing its value from the perspectives of Iclick, subcutaneous injection with autoinjector approved in the US for initiation treatment; the establishment of a platform that connects its high dosing convenience to access to treatment; the real-world evidence supporting the long-term treatment value presented at AAIC 2026; and the implementation of blood-based biomarker, or BBM. Regarding the pipeline, I will explain the progress of next-generation AD disease-modifying drugs, including the announcement of the E2814 tau biomarkers presented at AAIC.
Furthermore, I will introduce our drug discovery aimed at realizing make AD across the disease, where amyloid, tau, and neurodegeneration are considered as an AD continuum, the orexin pathway platform, and the future key events for pipeline. Next slide, please.
Let's talk about Lenvima. First-quarter revenue reached ¥97.3 billion, up 16% year on year.
In addition to the impact of exchange rates, sustained demand growth, particularly in the United States, is driving this growth. In the US, it continues to hold a top market share in the TKI market for renal cell carcinoma, endometrial cancer, hepatocellular carcinoma, and thyroid cancer.
11 years after its launch, it has grown into a strong revenue foundation for our company, contributing to approximately 620,000 patients in 83 countries. The addition of a new indication based on the results of LITESPARK-011 on patients with advanced renal cell carcinoma with prior treatments with anti-PD-1 or PD-L1 therapy is scheduled to reach a PDUFA action date, the target deadline for FDA's review in the US on October 4th, 2026.
We aim to achieve our full-year forecast of ¥345 billion through both the sustained growth of existing indications and the expansion of indications through lifecycle management. Next is Dayvigo.
First-quarter revenue reached ¥18.9 billion, up 38% year on year, with growth across all regions. We are on track to achieve our full-year forecast of ¥73.5 billion.
In Japan, supported by its ability to improve both sleep onset and sleep maintenance, it has maintained the number one market share in both sales and the number of patients treated in the dual orexin receptor antagonist segment, according to our estimates based on JMDC data. It has continued steady growth in the US, Canada, and China as well.
Furthermore, in July, we submitted applications for approval in the UK and Europe for the treatment of chronic insomnia. Having already been approved in 29 countries and territories, it will further accelerate growth as a global brand.
The knowledge we've gained in orexin drug discovery with Dayvigo is also leading to our next-generation orexin platform, which I will explain later. Next, please.
Next is Leqembi. First-quarter revenue reached ¥29.3 billion, up 27% year on year.
Excluding our estimated temporary impact of stockpiling by distributors in China that occurred in the same period of last year, revenue increased by 64% year on year, indicating continued strong growth on a real-demand basis. In the United States in particular, supported by the increasing number of patients with early AD and the expansion of blood biomarker testing volumes, Leqembi continued to grow, maintaining its leading share in terms of the number of patients treated based on our estimate.
Furthermore, on July 13th, Leqembi Iclick was approved by FDA for initiation treatment. In Japan, demand is expanding while absorbing the impact of drug price revision.
In China, reimbursement has commenced under several commercial insurance programs, and negotiations with authorities for reimbursement are ongoing in various countries across EMEA. Currently, we have obtained approval in 53 countries and territories for early AD.
We aim to achieve our full-year forecast of ¥143.5 billion by leveraging new technological innovations such as Iclick and BBM to drive growth. I would like to share with you our efforts to maximize the value of Leqembi.
Leqembi is the only anti-A-beta antibody that can be administered long-term and that suppresses the disease progression, as well as slows the decline in cognitive function and activities of daily living. In the United States, on July 13th, Iclick initiation treatment approval was granted, and sales is expected to begin in late August.
With this approval, from the start of the treatment, patients are able to choose from IV or Iclick. From the initiation therapy to maintenance treatment, treatment options can be offered based on patient circumstance.
The major value of Iclick comes not only from its convenient formulation, but after two consecutive treatments under the guidance of healthcare professionals, home administration becomes possible for patients when deemed appropriate. This reduces the burden to travel to clinics for patients and care partners.
It also is expected to reduce burden for medical institutions in terms of infusion, freeing up human resources for other core needs. At AAIC 2026, modeling and simulation-based analysis was presented, showing equivalent exposure between once-weekly SC maintenance and IV treatment, and projected equivalent clinical efficacy and amyloid removal.
Exposure-related AEs, ARIA, are projected to be similar to IV administration, and the safety profile of SC administration is strongly similar to IV. According to the device evaluation, 94% responded that it is easy to use.
We believe Iclick will expand the treatment options for patients, making Leqembi treatment easier to start and to stay on. On the other hand, approval and sales of products alone do not lead to the start and continuation of treatment.
To translate convenience offered by Iclick to improved patient access and Leqembi growth, development of three key foundations is important. First, streamlining the treatment access including coverage and reimbursement and prior authorization.
Second, standardization of diagnosis and treatment initiation flow from testing to documentation of results, benefits verification for each patient, then coordination with specialty pharmacies. Third, enhance support structure for home administration and treatment continuation including drug delivery, administration training, storage, and continuous shipping management and sending reminders about drug administration and MRI.
Our aim is to establish conditions not only for clinics to prescribe Leqembi, but for patients to actually start receiving treatment and continue with treatment. Towards the launch in late August, we will proceed in collaboration with the payers, medical institutions, and specialty pharmacies to ensure the establishment of the three key foundations.
We will translate the convenience of Iclick into better patient access and advance Leqembi into the next phase of medium-term growth. Next, moving to the real-world data that demonstrates long-term treatment continuation.
This is not RCT, but this is an observation data using chart. At AAIC 2026, the LEADER study data from 432 early AD patients across 13 clinical practices in the US was presented.
82.5% of patients whose disease stage were evaluated were stable or improved. Treatment retention rate was 86.6% at the time of chart extraction of all 432 patients.
Safety observations were consistent with the FDA-approved label. Most ARIA events were asymptomatic or mild on imaging.
There were no reports of macrohemorrhage or treatment-related deaths. Among 144 patients treated for more than 18 months who continue to be on treatment at the time of chart extraction, 161, or 78.9%, transitioned to maintenance treatment with Iclick or IV, and remained on treatment.
Based on these, we consider the data to be important real-world evidence that proves Leqembi treatment continuation, consistency in safety, and current usage of maintenance therapy. To maximize treatment opportunities with Leqembi, it is important to standardize A-beta diagnosis and to improve patient access.
Blood-based biomarkers put less burden physically on bodies and can alleviate geographic constraints as well as PET and CSF testing capacity constraints. By using BBM as triage, PET and CSF A-beta positivity rates can be increased to efficiently use limited testing resources.
BBM that satisfies certain performance standards may be a means of A-beta pathology confirmation in place of PET or CSF. According to estimates by Eisai, in the US, BBM tests increased in number by 75% in fiscal 2025 year on year.
The ratio of BBM in A-beta confirmatory testing is expected to increase from 15% in fiscal 2025 to around 50% in fiscal 2028. The environment surrounding BBM is rapidly becoming ready, centering around p-tau217 in the US, Europe, and Japan.
There has been progress in approval, regulatory filing, and commercial testing availability. Development of guidelines and treatment infrastructure is accelerating.
With BBM, we aim to expand the base of patients who will seek diagnosis and reduce time required for diagnosis to expand Leqembi treatment initiation opportunities. Combination of BBM for diagnosis and Iclick for treatment is expected to improve the overall flow from diagnosis to treatment continuation for patients.
Next slide. Now I'd like to turn to the next-generation AD drug discovery.
Etdalanetug is at the core of tau aggregates and targets MTBR tau, responsible for tau propagation. Through binding with tau seeds, etdalanetug promotes removal of microglia to suppress tau removal in microglia to suppress tau propagation and aggregation.
In the Phase 1b/2 study in dominant inherited Alzheimer's disease patients achieved 60% reduction of eMTBR-tau 243 in CSF in three months and 89% reduction in nine months. 78% reduction in plasma in three months and over 90% reduction in nine months were also observed, demonstrating consistent changes in biomarkers in both CSF and plasma.
In tau PET, a trend towards suppressing progress on reducing tau pathology was also observed in key participants. As of now, these do not demonstrate efficacy in clinical symptoms, but we believe that lowering of eMTBR-tau 243 and tau PET tendencies support the effect on tau pathology targeted by etdalanetug, and we believe the proof of mechanism was obtained.
As presented at AAIC, plasma eMTBR-tau 243 show potential to be used as blood biomarker for more convenient way to evaluate tau pathology in the brain. Next important data to consider will be the top-line data from Phase 2 study in sporadic AD patients, expected in fiscal 2027, and from Tau NexGen study, expected in fiscal 2028.
Next slide. Talked about tau, etdalanetug, I have just discussed, but AD progression is considered in three domains of A: amyloid, T: tau, and N: neurodegeneration.
As we pursue the next-generation drug discovery regarding amyloid in AHEAD 3-45 study, in preclinical AD patients before the onset of cognitive symptoms, to demonstrate the efficacy would not allow develop Leqembi's test. This is a Phase 3 study designed based on FDA and EMA guidance.
We expect to obtain data in fiscal 2028. Preclinical AD population is estimated to be 400 million globally, but not all will be target patients.
Considering testing, diagnosis, and treatment access, Eisai assumes that there are approximately 2.3 million patients for AD DMT treatment. We intend to target patients with biomarkers and aim to respond to the unmet medical need of intervention before the onset.
As for tau, etdalanetug aims to suppress disease progression through intervention of tau propagation. In the future, we expect to combine A-beta pathology control with Leqembi and tau pathology intervention with etdalanetug.
Moreover, by adding interventions in neurodegeneration and neuronal function, we aim to establish treatment approach to prevent onset and progression of AD. We call such long-term vision of combining pre-onset intervention and suppression of disease progression make AD curable.
Next, moving on to orexin platform. Eisai has been addressing sleep-wake regulation in insomnia with Dayvigo, which blocks orexin receptor, leveraging expertise from that drug discovery.
Currently, we are developing daridorexant—letorexant, an in-house developed agonist which activates orexin 2 receptor. In study 101 in patients with NT1, it was shown that single-dose administration significantly reduced excessive daytime sleepiness.
At the dose that demonstrated efficacy, letorexant—letorexant was considered well tolerated, with no liver dysfunction or visual abnormalities observed. Currently, Phase 2 study 202, evaluating NT1 and NT2 in the same study, is ongoing.
Top-line data is expected before the end of fiscal 2026. This strategic position of orexin drug discovery is not limited to insomnia treatment.
Nighttime sleep is supported by Dayvigo, while daytime wakefulness is supported by letorexant. We are developing these from both directions, and in the future, we aim to expand the potential of drug discovery to regulation of brain function networks that support daytime functioning, including cognition, behavior, and social participation.
This page shows the major pipeline events and strategic positions of each project in the three-year plan. In neurology, after the US approval of Iclick, initiation treatment approval in Japan is expected in Q2 fiscal 2026.
Letorexant Phase 2 top-line data as well as E2025 CSF biomarker data are also expected in fiscal 2026. In the medium term, important data is expected from sporadic AD etdalanetug study, or 202 study in fiscal 2027, and from AHEAD 3-45 and Tau NexGen in fiscal 2028.
In oncology, for Lenvima and belzutifan combination therapy, US PDUFA action date is scheduled in October 2026. Tazemetostat regulatory filing in Japan and E7386 top-line data are also expected.
These events are linked to our three-year plan strategy: establishing Leqembi as standard of care, making Dayvigo a global brand, next-generation drug discovery including etdalanetug, and enhancement of oncology pipeline. By determining the scientific and business values and success probabilities of each project based on strategic positioning, resource will be allocated and plans will be executed according to the priorities so that three-year plan can be achieved.
I would like to summarize the key points from today before I end. With regards to management foundation, the strength of 3L growth products, namely Lenvima, Dayvigo, and Leqembi, drove year-on-year increase in both revenue and operating profit company-wide.
We are making steady progress towards achieving fiscal 2026 forecast. In terms of business growth, Leqembi continues to achieve sustained growth, primarily driven by the US.
Dayvigo growth across all regions accelerated global expansion. With respect to Leqembi, Iclick is offering more options for treatment; BBM is advancing diagnosis environment.
Combining these advances, we are enhancing foundation to expand diagnosis and treatment access for patients. In pipeline development, in neurology, based on AD framework of continuum of amyloid, tau, and neurodegeneration, we are pursuing next-generation AD drug discovery.
In orexin, leveraging the sleep-wake regulation, we've expand drug discovery possibilities to daytime functions of cognition, behavior, and social participation. In oncology, in addition to Lenvima additional indications, licensed-in products and in-house products will be combined to enhance pipeline for the future growth.
Going forward, we will continue to enhance revenue earnings foundation with three growth products, and we will also drive growth through next-generation drug discovery. We will create a cycle of investment that links the current growth to the next wave of phase of growth with disciplined resource allocation and steady execution to achieve sustainable enhancement of corporate value.
This concludes my presentation. Thank you very much.
Operator
We will now move to the Q&A session. First, we will take questions from the analysts and then questions from the members of the media.
If you have questions, please give us your name and organization name before your question so that we can accommodate as many questions as possible. Please limit the number of question to one per person.
I would first like to invite questions from analysts. Mr.
Yamaguchi from Citi Group, please unmute your microphone and start asking your questions.
Hello. Can you hear me?
This is Yamaguchi from Citi Group Securities. Thank you.
I am asked to limit the number of questions to one. Regarding the progress of Q1, I would like to ask you questions in one question.
There is a high progress against the medium-term plan and full-year decline was observed for gross profit. However, as this full year, I think it is a relatively good gross profit.
Do you have any take on this progress against the plan as well as the gross profit and forex any better impacts or positive impact from forex than expected? Could you please share with us?
Thank you very much for your question. Our CFO Oyama is going to respond to your question.
Takuya Oyama
Thank you very much for your question. At the first quarter, given the strong growth of 3L products as well as other products and the organic business continued to grow, therefore operating profit was better than the full-year forecast.
During the first quarter, plan for the first quarter was exceeded by actual performance. Regarding revenue, as you said, there was an impact by foreign exchange rates, but excluding forex impact, performance exceeded our plan.
For cost, Leqembi, Dayvigo, and the cost ratio of our key major products have been reduced. In some areas, they are prioritized launching, but in principle, organic business has continued to grow steadily.
Let me ask you one follow-up question. Leqembi and Dayvigo revenue has been strong, and the product mix has been improved.
Leqembi and Dayvigo, individually, cost of sales have been reduced for each of these?
Takuya Oyama
Yes, cost for individual products have been reduced.
Compared to your expectation for the full-year forecast?
Takuya Oyama
We believe that we have been able to make a steady start, good start, to achieve the full-year forecast. Thank you.
That's all.
Operator
Next, Mr. Seki from UBS Securities, please unmute and proceed with your question.
This is Seki from UBS. Thank you very much for this presentation.
Congratulations on the approval of Iclick initiation treatment. About the Medicare's reimbursement, how are you looking at about this?
In August, there is a window opening for document revision in August, according to the information that I've heard. Will you be making use of that?
Although it was fast-settling when approval was given, is it possible to start Medicare's insurance reimbursement starting next month? Leqembi Iclick has the one dose, and I believe it was the same Q-code and number for ordinary the Medicare reimbursement.
What is about new product reimbursement? This is an additional indication, the current reimbursement may be applied for initiation treatment.
What is your current outlook?
Keisuke Naito
Thank you for your question. About Iclick initiation treatment and the question was on insurance reimbursement.
Regarding maintenance treatment, through medical exception, insurance reimbursement is provided. For Iclick initiation treatment, we expect a similar scheme to be applied.
From 2027, payers will begin to list Leqembi in Medicare Part D formulary. In this way, we expect expansion of reimbursement.
Based on priorities, we would like to work on ensuring reimbursement from major payers. I hope this addresses your question.
Thank you. Mr.
Haruna, responsible for Leqembi in US, may have additional comments.
Katsuya Haruna
Thank you for your question. I am Haruna, responsible for Leqembi globally.
I'd like to offer some additional comments. COO Mr.
Naito responded earlier. In particular, regarding the formulary listing, maintenance therapy and initiation therapy, we expect to have both on the formulary.
Initiation therapy approval was granted recently, and therefore, we expect a listing in the formulary for both maintenance and initiation therapy eventually.
Operator
I would like to invite next participant from JP Morgan Securities, Mr. Wakao, please unmute your microphone.
This is Wakao from JP Morgan. Thank you very much.
I also have a question about the US situation of Leqembi, particularly Iclick for initiation treatment, WAC or price, and also contribution by Iclick can be expected at this timing. Could you please elaborate on this?
WAC for Iclick, considering the news release regarding the Iclick in the United States, 250 mg per bottle, $385 per vial, then that means the price can be double the price of maintenance treatment. With this pricing, do you think that you will be able to secure enough sufficient profitability?
Takuya Oyama
Thank you very much for your question. Mr.
Yasuno, who is in charge of US business, is going to respond.
Tatsuyuki Yasuno
Thank you very much for your question. I am in charge of US business.
My name is Yasuno. Regarding the basic concept for pricing, basic concept is to achieve price parity between the IV and Iclick SC on the basis of a total medical cost.
Iclick, as it has been explained today, will allow patients to do the self-administration at home, which will provide convenience and also reduce the cost related to the travel, as well as the burden for care partners. Also, it will do away with the resources at medical institutions which will be required for IV.
Therefore, these are considered to be added value. These added values are added on reflected on the price for the Iclick.
On the other hand, the cost related to infusion for other costs than the drug itself in terms of IV, such as infusion procedure, on a total medical cost basis, we have designed the pricing for Iclick so that there will be no change in the copayment by the patients. Based upon these, we have come up with the pricing.
Thank you very much. 250 mg per vial, $385 per vial.
Is this correct?
Tatsuyuki Yasuno
Yes, that is correct about WAC.
Understood. Then for maintenance, and then this shall secure the profitability.
Initiation treatment, the timing of launching the Iclick, and at which point in time do you expect this Iclick to start contributing to your performance? Do you think that there will be signs of a contribution in the second quarter onward or even ahead?
Keisuke Naito
Thank you very much for your question. As SC has just been launched, in the future, the convenience of SC will exceed the IV, the share is exceeding for SC over IV in the future.
In my presentation, I've mentioned there will be additional optionality for patients to do the home administration, and then introduction of new patient will be accelerated. Also, the penetration of the BBM-based confirmatory diagnosis is going to be the key point for further penetration of Leqembi.
As I've mentioned in the presentation, there will be a preparation and establishment of various foundations and platforms. Therefore, for patients to be able to receive the benefits of SC should be made easier by our efforts.
Have you started the launch, selling this?
Keisuke Naito
Regarding actual situation, I'd like to ask Mr. Haruna, who is in charge of US business.
Katsuya Haruna
My name is Haruna. I am in charge of global Leqembi business.
I would like to respond. Regarding the commercial launch timing, it's scheduled to be late August.
From that point onward, actual drugs will be delivered to patients. Having said that, the product itself has been approved already.
Prescriptions can be started based upon the description of medical institutions. When we visit the medical institutions in the United States, I see prescription have started, and we are seeing increasing number of inquiries for Iclick initiation treatment is gaining a lot of expectations throughout the United States from many medical institutions.
That is the current status we see.
Thank you. On a monthly basis, or you mean that you have started to see the booking of sales?
Katsuya Haruna
Sales have not been recorded yet, although prescriptions have started, but the Iclick 250 mg are to be launched in the United States, which is to come around late August. From that point onward, I believe that the sales will start to be booked.
Operator
Mr. Tony Ren from Macquarie Securities, please unmute and proceed with your question.
Tony Ren
Hi, yeah. Thank you for taking my question.
My question is about your effort in the US to convert patients from Eli Lilly's Kisunla, which is a fixed duration therapy. I understand that you have been trying to convert Kisunla patients who stopped their fixed duration therapy, but who are also concerned about redeveloping plaques, preventing them from coming back.
Can you give us some color about how that effort is going? Thank you.
Keisuke Naito
Thank you for your question about the share between Leqembi and Kisunla. I understood your question to be a market share between the two drugs.
IQVIA and other external data source market share calculations, I'd like to remind you that often these data do not cover some of the major IDNs that prescribe Leqembi, and about new patients, each of both drugs have about 50/50 market share. However, after the launch of initiation therapy Iclick, as we have been discussing, we believe that the market share may change.
This may overlap with the earlier response, but I would like to ask Mr. Haruna, responsible for global business, to respond further.
Katsuya Haruna
Thank you for your question. As I've mentioned earlier, in initiation therapy, Iclick was granted approval, and in the United States, doctors began to prescribe Iclick for initiation therapy, and I feel expectation for Iclick, patients may wish to have once-monthly administration, but with the home administration with Iclick, not only for patients, but for healthcare professionals, we expect the burden will be reduced significantly.
As presented in the presentation today, we've reported on results from LEADER study. From LEADER study, more than 18 months, 80% or thereabouts of patients, the majority of the patients, 80% or so, wish to be to stay on treatment and are given maintenance therapy.
Whether patients will discontinue or stay on therapy, which was part of your question, and as a matter of fact, majority of the patients wish to stay on the treatment, and what we have consistently saying is that, or our position, consistent position, is accepted by patients and healthcare professionals. With the introduction of highly convenient Iclick, we believe that we will have greater competitive advantage, and we believe that as a result, our market share will further expand.
Thank you for your question.
Tony Ren
If I may just have a quick follow-up. For the patients who stopped Kisunla because they've reached the end of their fixed duration therapy, have you been able to convert some of them to take maintenance Leqembi?
Keisuke Naito
The answer is it is possible. I would like to once again ask Mr.
Haruna to address that question.
Katsuya Haruna
As Mr. Naito, COO, responded, according to the label, from IV to Iclick conversion is possible, and similarly, patients who stopped treatments of Kisunla, it is possible to transition to convert to Leqembi, and in actual clinical practice, we are seeing such conversions.
Tony Ren
Very good. Thank you very much.
Moving on to the
Operator
next question. Tokai Tokyo Intelligence Lab, Yoshida-san, please unmute yourself.
Tokai Tokyo Intelligence Lab,
my name is Yoshida. Thank you very much.
Slide number three, Mr. Yamaguchi asked a similar question as a follow-up.
On cost of sales ratio seems to be much lower than the plan. What is the background for this better result?
In your explanation earlier, the revenue was larger than the expectation, and also costs were lower than the expectation. Could you please elaborate on that?
Comparing the first half and the second half, first half, do you think that the loss is decreasing so Leqembi, then it will accelerate the reduction of the loss. Once profitability is achieved, do you think that the recovery rate of the cost is going to be slowing down?
How do you think? Could you please give us your take on this?
Thank you very much for your question. Our CFO Oyama is going to respond.
Takuya Oyama
Thank you very much for your question. Cost of sales ratio was explained earlier in our response.
Leqembi and Dayvigo, individual products' cost of sales ratio were reduced, and Lenvima's revenue has been strong, including the positive impact of forex. Lenvima's cost of sales ratio was very low.
That also contributed to this better result. Regarding Leqembi, your point about Leqembi, we still have the second, the third, and the fourth quarter.
We expect to see further increase of the revenue for Leqembi. Towards that, we are continuing to invest SG&A expenses, and excluding R&D expenses, we'd like to secure achievement of the commercial basis profitability.
As of now, it is difficult for us to mention any trend so far, I hope you understand.
Could you please share with us Leqembi, Dayvigo, Lenvima, what is the contribution ratio among these three products?
Takuya Oyama
Lenvima is contributing the most? Compared to the last fiscal year, all these have stayed on the same level.
Compared to the plan, Lenvima revenue was larger than expectation. That was a great factor for this better result.
Thank you very much. Understood.
Operator
Moving on to the next question, Hashiguchi-san from Daiwa Securities, please unmute and proceed with your question.
I'm Hashiguchi from Daiwa Securities. About orexin drug discovery potential, you've made mention of this several times.
You are conducting study on narcolepsy, but for other indications about research and development, you also mentioned potential research and development outside of narcolepsy indication. Regarding these indications in letorexant, will you be pursuing these new indications, or with a different compound will you be pursuing research and development?
Regarding these indications, when do you expect to be able to begin clinical studies? What is the timeline that is expected at the moment?
Thank you for those questions. Dr.
Ido, responsible for R&D, will respond to your question.
Katsutoshi Ido
Thank you for your question. I'm Ido, responsible for R&D.
Regarding your questions, we are considering both. That would be our response.
As you've referred to in your question, letorexant Phase 2 study, this is covering both narcolepsy type 1 and type 2, and this study is making steady progress, and compound profile will be clearly elucidated, and we expect the top line within this fiscal year. Based on that profile that is understood, we would like to develop plans for more details and development beyond this fiscal year.
What is our platform, and we also do research of biomarkers, and regulation of other diseases may be indicated, and what is the desired profile that is also explored in exploratory research, and next-generation compounds will also be considered in the research and development. I hope this answers your question.
Thank you very much. About letorexant drug discovery, the history of the drug discovery was presented before.
I believe that a very large number of candidates were considered, and one out of many candidates was identified, which gave me an impression that there is not much progress with regards to other compounds. There are compounds with different profiles that are being explored, and what to what extent are you making progress in this exploratory research?
Katsutoshi Ido
As you mentioned in your question, we presented the drug discovery story of the initial discovery out of several hundreds of thousands. We found this compound, which was a hit.
As we continued with this development, we were able to expand the library of similar compounds, finding compounds and create a good information, but there are compounds with a very interesting profile. Combining that library and biology, we are pursuing next-generation drug discovery.
Thank you very much.
Operator
From Bernstein Securities, Ms. Sogi, please ask your question.
Thank you very much. Regarding IV and Iclick, I have a question about margin profitability.
WAC basis calculation per patient per month, Iclick can enjoy the WAC of 4.5 times as much as IV, and one-three the volume of API for drug, Iclick consumes double, because Iclick uses two times two, for one month. The other day, I asked you a question, COGS driver is mainly by API, I assume that Iclick can enjoy higher profitability than IV.
On the other hand, Lenvima is shrinking in mix, and then that is considered to be a driver for COGS improvement. Iclick, IV, and Leqembi, Leqembi itself as a whole is going to see better profitability going forward.
Is this correct understanding?
Takuya Oyama
Thank you very much for your question. My answer may be overlapping partly with what we responded.
Mr. Yasuno, who is in charge of US business, is going to respond to your question.
Tatsuyuki Yasuno
My name is Yasuno. I am in charge of US business.
Thank you for your assessment. Of course, the volume of Iclick is increasing, and we expect to see lower COGS ratio, we expect to see a better COGS rate.
Thank you very much. Next,
we would like to take questions from the members of the media. If you have question, please raise your hand.
Yoshino-san, please unmute and proceed with your question.
Thank you for taking my question. I am Yoshino from Nikkan Yakugyo.
I have a question on Slide 9 regarding Leqembi. Maintain top share in patients receiving treatment in what market is this, anti-amyloid-beta market?
It is needless to mention, but could you specify market share in which market?
Takuya Oyama
Thank you for your question. This is in anti-amyloid-beta market, and based on claims data, this is in-house estimate.
Thank you very much.
Any other questions from the media? If you have any, please raise your hand.
Nakada-san, please unmute yourself.
Can you hear me?
Operator
Yes, we can.
My name is Nakada. I'm from Nikkei newspaper.
With weaker yen, what is going to be positive impact of weaker yen, or do you see any negative impact on the profitability or earnings?
CFO Oyama is going to respond.
Takuya Oyama
Thank you for your question. Thank you very much for your questions.
With the weaker yen, what is going to be the impact on us? We have revenue majority of revenue is foreign currency denominated.
There is a impact on the revenue by forex, but on the other hand, there are R&D expenditures and other SG&A expenses on a foreign currency. For your information, revenue year on year, ¥18.9 billion was the impact of forex.
This was a positive impact by forex. When it comes to the SG&A and R&D expenses considered, and operating profit, based upon the same forex, there was a ¥1.38 billion positive impact.
Out of the ¥24.7 billion operating profit, part of which was due to forex impact. In principle, revenue and a cost majority of those are on foreign currency denomination, but the impact on the operating profit was limited.
Understood. Thank you very much.
Are there any other questions? If not, and if you have additional questions, please contact IR or PR.
With that, we will close today's briefing session. Thank you all for joining us today.
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