Eisai Co., Ltd. (OTCPK:ESALF) Q3 2022 Earnings Conference Call February 6, 2023 3:15 AM ET
Company Participants
Tatsuyuki Yasuno – Senior Vice President, Chief Financial Officer, Chief IR Officer
Ivan Cheung – Senior Vice President, Global Alzheimer’s Disease Officer, President, Americas Region Chairman & Chief Executive Officer, Eisai Inc.
Akiko Nakahama – Vice President, Chief Portfolio Officer, AD Filing and Registration Japan/Asia Lead Quality
Conference Call Participants
Hidemaru Yamaguchi – Citigroup Global Markets Japan Inc.
Motoya Kohtani – Nomura Securities Co., Ltd.
Seiji Wakao – JPMorgan
Fumiyoshi Sakai – Credit Suisse
Unidentified Company Representative
It is now time we would like to begin financial results presentation session by Eisai for the Third Quarter Fiscal 2022. This is held in hybrid format, including attendance in this room as well as online attendance. Those of you who are attending in this room, please make sure that you have distributed the materials including the deck of slides and fast reports. Those of you who are watching line, please continue to watch your screen.
Let me introduce the officers in attendance. President — Senior Vice President, Chief Financial Officer, Chief IR Officer, Mr. Tatsuyuki Yasuno; Senior Vice President, Global Alzheimer’s Disease Officer, President, Americas Region, Ivan Cheung.
Ivan Cheung, will be presenting in English. And in this room, we are securing enough distance, so masks will not be worn by the speakers. Presentation will begin. Microphone to you Mr. Yasuno.
Tatsuyuki Yasuno
Now, first, myself Yasuno, CFO, will present the consolidated financial results for the third quarter of fiscal year 2022. The main points of the financial results this time are as follows: due to the impact of many one-time revenues recorded in the previous year, revenue and profit decreased. However, the pharmaceutical business, which is our organic business grew steadily and both revenue and profits increased. In addition, we are continuously making solid investments for future growth.
First slide, here is the P&L. At the top line, revenue decreased to JPY546.2 billion, or 97% of the previous year’s level. This includes the impact of foreign exchange rates of JPY53.6 billion. And although there is a JPY51.8 billion impact from foreign exchange rates even including — excluding this impact of ForEx revenue grew steadily to 104% of the previous year’s level. R&D expenses totaled at JPY121.4 billion, which was 98% of the previous year’s level, with a total decrease of JPY1.9 billion despite JPY20.6 billion increase due to weaker yen. Excluding the impact of ForEx, R&D expenses would have been 82% of the previous year’s level.
SG&A expenses were JPY273 billion, which was 107% of the previous year’s level, but this includes a JPY37.5 billion increase due to the impact of foreign exchange rates. Excluding this impact of ForEx, SG&A expenses would have been at 92% of the previous year level.
Although expenses regarding shared profit of Lenvima paid to partner increased in line with its sales expansion. SG&A expenses excluding this shared profit expenses decreased significantly, indicating that the company is firmly managing its expenses.
Other income or expenses amounted to JPY1.3 billion for 9 months of the current fiscal year. As a result, operating profit was JPY13.8 billion, which was 19% of the previous year’s level. The foreign exchange impact was minus JPY10.8 billion.
For the Fycompa, the agreement for the divestiture of rights of Fycompa in the U.S was signed in December of last year, the closing of which was completed in January. And the impact will be recorded in the fourth quarter of this fiscal year. The divestiture of Eisai distribution, the agreement of which was also signed in December last year, is expected to be accounted for at the time of the share transfer slated for March 31 this year.
Although the progress in operating profit, which was JPY13.8 billion during the 9 months, this seems to be delayed as compared to the full year forecast. But as I said earlier, there were two strategic options for which agreement has been already signed and for other strategic options as well which are steadily progressing. Therefore, in addition, our core business, pharmaceutical business which is showing the steady growth. Therefore we’re even more confident that full year forecast will be achieved.
Next please. Here, I’ll be explaining the factors behind the increase and decrease in revenue, utilizing this waterfall chart. Top left, last year’s revenue was JPY565.3 billion, in the first 9 months of last fiscal year, and this year was JPY546.2 billion was recorded for this fiscal year, a decrease of JPY19.1 billion and JPY68.1 billion year-on-year increase was recorded with double-digit 15% in pharmaceutical business. And so both revenue and profit increased. So this was mainly due to the growth of global brands.
For Lenvima, which grew by JPY50.2 billion year-on-year mainly in the U.S. Dayvigo grew mainly in Japan by JPY10.6 billion. Halaven and Fycompa also showed a solid growth both in revenue and profit. And therefore, there was a JPY69.8 billion increase from the previous year for the four global brand products combined.
On the other hand, in other business, there was the one-time upfront payment for MORAb-202 with JPY49.6 billion recorded in the last fiscal year and also Lenvima sales milestone payments received in the amount of JPY34.5 billion. Therefore, inclusive of these impacts, the revenue decreased by JPY87.2 billion. Although there were a decreases in the revenue because of the one-time payment. However, as I have said earlier, we have seen the solid growth, particularly in the pharmaceutical business.
I would now like to touch on Lenvima, which is driving the strong growth of pharmaceutical business. As you see on the left graph towards right side of the left graph, in the first three quarters, revenue was globally JPY191.3 billion, growing up 36% year-on-year. Excluding foreign exchange impact, the growth was 14%, which was a double-digit growth.
Lenvima is establishing position as backbone therapy with six indications in five cancer types. In particular, combination with KEYTRUDA in RCC in endometrial cancer is driving growth. As shown at right bottom, with these data, we will continue to aim at further expansion as a standard therapy.
Next, I would like to touch upon the breakdown of the operating profit migration using similar waterfall chart. Left chart shows that April to December, TICS scored 21 operating profit was JPY74.3 billion. And in this fiscal year, there was a decline of JPY13.8 billion. As shown on the right side, the earlier mentioned pharmaceutical business revenue rose, and as a result, pharmaceutical business segment profit increased JPY54.1 billion year-on-year or 27% year-on-year which is a high-level of double digit growth.
Furthermore, regarding the profitability, there was a substantial improvement. All five regions achieved increase in operating profit. Below that, in other business, as I mentioned in relation to revenue, because of one-time income in the previous year, in this segment operating profit was negative JPY88.7 billion. As for [indiscernible] R&D expenses this year in AD area including LEQEMBI, there was a prioritized investment of resources also in other focus areas.
On the other hand, Lenvima and ADUHELM-related expenses decreased. Partnership model was used to improve efficiency and overall efficiency was improved. And on the whole, in comparison to the same period previous year, R&D expense decreased by JPY1.9 billion, pushing up the profit. However, R&D expense including partners reimbursement was 32.1%. Growth investment continues at high-level and we are making — continuously making active investment in the future growth.
As for other SG&A expenses, Lenvima shared profit is increased — include — included here and increase of a shared profit Lenvima result [indiscernible] decline of other SG&A expenses of JPY16.5 billion. Other profit and loss decreased by JPY11.3 billion year-on-year because in the previous year, Zonegran rights for divested.
As you can see, there were many one-time factors in the previous year, where one-time income was recorded in the previous year third quarter operating profit declined. However, pharmaceutical business segment operating profit further improved. This is the full year forecast for fiscal 2022 on a consolidated basis. There is no change or revision to the full year forecast.
With respect to the dividends, based on our strong balance sheet, as forecasted annual dividend payout forecast is JPY160 and we see no problem in maintaining that forecast. As I mentioned earlier, pharmaceutical business profitability, organic business is improving. And towards the end of the fiscal year, we will continue to work on improving profitability further. With regards to R&D investment, we will also make efforts to improve efficiency further.
In addition, there are already signed two strategic projects, which will be booked on the accounts in the fourth quarter. And there are strategic options that we are working on currently, which are showing steady progress and we will make sure to realize these. And with this, we believe that we will be able to achieve full year forecast. That concludes my part of the presentation.
Next, Ivan Cheung, will report on Alzheimer’s disease area. Mr. Cheung, please.
Ivan Cheung
Thank you. As many of you already know, we at Eisai are honored for the LEQEMBI innovation to be recognized by Prime Minister Kishida during his Diet opening speech 2 weeks ago. Today, I want to provide an update about the positive dynamics and momentum behind LEQEMBI, since the Accelerated Approval granted by the U.S FDA on January 6.
First and foremost on this slide, we are more than grateful to the hard work by the FDA and the Eisai team to deliver a transparent and informative label, which has drawn significant interest from physicians, medical institutions and payers, to engage with the Eisai teams, to discuss how to select patients, how to administer the therapy, and how to do monitoring, such as how to identify ARIA and what to do when ARIA occurs.
We have received many, many requests for engagements from physicians, medical institutions and payers. For example, one neurologist recently told the Eisai team that he needs his clinical practice and Eisai to be both successful for LEQEMBI, because if we are both successful, it will start a paradigm shift that will change patients lives. Overall, what I can say is the feedback from the market are positive with high enthusiasm from physicians, medical institutions and payers to seek out more information about LEQEMBI.
Next slide please. We are also very encouraged that on January 6, both the FDA and the CMS put out public statements about LEQEMBI’s Accelerated Approval, underscoring the importance of this day to the Alzheimer’s disease community and to the American public. Let’s first take a look at the FDA public statements. On January 6, Dr. Billy Dunn, Director of the Neuroscience Division at the FDA said, as you can see on this slide, Alzheimer’s disease immeasurably incapacitated the lives of those who suffer from it, and it’s devastating effects on their loved ones. This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease, where the Eisai share his sentiment.
Next slide please. Now let’s take a look at the CMS public statements on January 6. The CMS often does not make these public statements, but they do on January 6. Chiquita Brooks-LaSure, CMS administrators said, at CMS, we will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs that improve clinically meaningful outcomes.
If LEQEMBI subsequently received traditional FDA approval, CMS would provide broader coverage using the framework we announced last year under coverage with evidence development on the same day. The last phrase is very important. On the same day, we at Eisai commend her statement that broader coverage for Medicare beneficiaries would be provided on the same day when LEQEMBI received full traditional approval from the FDA.
Next slide please. One consistent feedback from our stakeholders upon the FDA Accelerated Approval is Eisai team’s efficiency to move with urgency for the sake of patients and their families. On January 6, on the same day that we received the Accelerated Approval for LEQEMBI from the FDA, we submitted the supplemental BLA to the FDA, based on Clarity AD data for full traditional approval.
The same day action reminded our stakeholders of another reason same day action from Eisai, which was back in November 2022 when we publish our Clarity AD results in the New England Journal of Medicine on the same day we presented the detailed data from Clarity AD for the first time at the CTAD Medical Congress.
Shortly after January 6, which was a Friday, on Monday, January 9, we submitted the Marketing Authorization Application to the EMA in Europe for LEQEMBI. Then quickly on the following Monday, on January 16, we submitted the new drug application to the PMDA in Japan. In just 10 days, we received the priority review destination for LEQEMBI from the MHLW in Japan.
Meanwhile, we continue to be making solid progress with health authorities in other countries. For example, we have already started submitting data to the China CDE in December last year under the price Category 1 designation that allows for the most expedited review. Overall, fiscal year 2023 will be a critical year for Eisai and for LEQEMBI with many approval and launch milestones.
In the United States, if the FDA grants Priority Review to our supplemental BLA application, we could receive full traditional approval and broader coverage from the CMS in the summer of this year, just several months away. In Japan, under Priority Review, we could receive approval by the middle of fiscal year 2023, again, several months away only. For both Europe and China, we could receive approvals before the end of fiscal year 2023 where Eisai committed to bring LEQEMBI to appropriate patients and their families even one day earlier around the world.
Next slide please. Another consistent feedback from our stakeholders upon the FDA Accelerated Approval is Eisai’s transparency with regard to the rationale and the detailed mathematics behind the U.S pricing based on societal value of LEQEMBI, the industry first with this level of transparency and the commitment to give back to society. We estimated the societal value of LEQEMBI in the United States to be $37,600 per year per patient. And we priced LEQEMBI at $26,500 per year for a patient of average weight and this number will further go down significantly during the maintenance dosing regimen of less frequent dosing.
Over 10 years, the gradual adoption of LEQEMBI at this pricing approach could give back about 60% of the potential positive social impact of several tens of billions dollars to the U.S society, including patients, families, caregivers, health care providers, and payers. On the other hand, the remaining 40% to be accrued by employees and shareholders will be reinvested into further research and development to create new AD therapies and new ecosystems for inclusive AD communities.
Since January 6, when this U.S pricing announcement went out, Eisai has been held in high regard by many stakeholders with this pricing approach. While initial conversations with payers in the United States in a typical pharmaceutical launch, start with discussing and oftentimes defending the price. Our transparent pricing announcement allowed our initial engagements with payers in the United States about LEQEMBI to go straight to the important clinical discussions.
Moreover, payers in the U.S appreciate our published at AD ACE model, which produce results similar to the ICER model despite different methodologies. Beyond the U.S., we will apply similar pricing approach based on the AD ACE model with Clarity AD data tailored to the unique conditions in each country.
Next slide, please. Now let me give an update on how we are accelerating our efforts with various payers in the United States. So far, we’ve received many, many requests from payers to conduct clinical data presentations. With high-level of engagement, payers appreciate our transparency in data exchange and frequent discussions about LEQEMBI safety profile, efficacy profile and clinical meaningfulness.
With regard to the CMS on the left hand side of the slide, which covers about 85% of eligible early AD patients in the United States. The Eisai team has had numerous productive interactions with the CMS, since the CMS issued the NCD policy last year. We met many times to discuss a Phase II data and a Phase III Clarity AD data for LEQEMBI.
Our goal with the CMS is simple. Our goal is to motivate CMS to establish broad and simple right and simple Medicare access to LEQEMBI. As I mentioned earlier, we are glad to hear on January 6, that the CMS could provide broader access on the same day after LEQEMBI receiving full traditional approval from the FDA.
Let me add two more points here about the CMS. One is that we recently did meet with the CMS post Accelerated Approval and we went through how LEQEMBI’s clinical data from the Phase III Clarity AD as well as our Phase II and also the open-label long-term extension data fully answered the three key questions required in the NCD policy, and therefore we believe qualifying LEQEMBI for high-level of evidence so that broad and simple Medicare access to LEQEMBI can be made available by the CMS within the existing NCD framework.
Second point is that we are pleased to know that the CMS and the FDA are communicating and working closely together with regard to evaluate LEQEMBI’s clinical data, which we believe is a very positive development in our view towards broaden Medicare access on the same day of LEQEMBI receiving all traditional FDA approval.
With regard to Veteran Affairs, VA, in the middle of the slide, VA is the largest integrated health system in the United States serving 9 million veterans and their families. VA makes their own independent formulary decision. And the Eisai team has had already several productive engagements with the VA, including explaining LEQEMBI’s clinical data and initiating preliminary contract term discussions. We’re hopeful that the VA will provide access to LEQEMBI soon, potentially even before LEQEMBI receiving full traditional approval from the FDA.
With regard to the commercial payers on the right hand side on the slide that cover individuals under the age of 65, the Eisai team has already completed clinical data presentations to all major commercial payers. There are many discussions about our clinical trials inclusion exclusion criteria, and monitoring approaches which signaled to us positively that these payers are working on their utilization management and prior authorization approaches that consider placing LEQEMBI on their formularies. Our overall objective is that shortly after LEQEMBI receiving full traditional approval from the FDA, vast majority of the eligible early AD patients in the United States will have unimpeded access. That’s our goal.
Next slide, please. Going back to the CMS topic, let me use a couple more slides to provide further insight. On December 19 last year, the Alzheimer’s Association which is the largest patient advocacy group in the United States, sent their final and formal request for reconsideration of the NCD for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease to the CMS as you can see on the left hand side.
On the right hand side, attached with this request by the Alzheimer’s Association is a letter undersigned by 220 AD researchers and clinicians titled treating Alzheimer’s, a new era begins with lecanemab. As you can see on the right hand side on the slide, let me read the last paragraph of this letter. As you can see at the bottom of the slide. The many undersigned AD clinicians and other experts know this terrible disease all too well from witnessing it up close. We have wrote the foundational advance represented by the advance of lecanemab therapy. Now, we must build on the success of science to translate these gains into even better outcomes for patients and families.
Autonomy and justice dictate that our patients have equitable access and the opportunity to make informed choices regarding reasonable treatments that can impact their lives and well being. No barrier can be allowed to stand between our patients and a treatment that has the reasonable risk benefit ratio and significantly reduces the causative pathology.
Next slide, please. Just last Thursday, the American Academy of Neurology, AAN which represents over a 38,000 neurologist put out their public letter to the CMS requesting expedited review of the NCD as it pertains lecanemab, because there is consensus among the AAN’s member experts and leadership, who have reviewed the Phase III data that the Clarity AD trial was well designed, and its findings are clinically and significantly and statistically significant — clinically and statistically significant.
Let me read the second last paragraph in this letter as you can see on the slide. To summarize, the AAN believes that the Phase III data from the Clarity AD trial indicating a direct clinical benefit warrants a focus expedited reconsideration of the existing coverage policy, as it applies to lecanemab. As it would have been impossible for CMS to consider this highly relevant data at a time that the NCD was published.
We believe to promote patient access to therapy, that it will be appropriate for this reconsideration to occur so the revised decision can be released with an effective date concurrent with a potential traditional approval of lecanemab. Furthermore, the AAN believes that a similar approach could be applied to future products which meet the standard set by the Phase III data published in New England Journal of Medicine.
Once again, the key concept here is AAN wrote, same day or CMS coverage when lecanemab receives traditional approval from the FDA. Of course, Eisai has nothing to do with the AAN letter or the Alzheimer’s Association letter on the previous slide, but you can see how stakeholders in the United States are coming together behind LEQEMBI with regard to early access for Medicare beneficiaries, which are, as I mentioned earlier, about 85% of the early AD patients in the United States.
Next slide, please. Besides the Alzheimer’s Association and the AAN, let me also share the comments from FDA commissioner, Dr. Robert Califf during his interview on CNBC, on January 10, when he was asked about the NCD situation for LEQEMBI. He said, the company, meaning Eisai, just submitted their data for full approval, not the Accelerated Approval. That’s going to be coming up. So I don’t expect the CMS policy to be a totally fixed policy. We have a lot of communication. We, meaning the FDA and the CMS. And I think they’ll reach a good spot. They meaning the CMS. He went on to say, I liken it to a relay race, where we need to make the baton handoff a lot smoother. It’s not a new problem, but this has really brought it to public attention, I don’t think is a bad thing.
We agree with Dr. Califf, that the coverage decision for LEQEMBI is an important for the American public, and it’s good for this to be brought to public attention. And we are very encouraged that the FDA and the CMS are working together closely on this matter.
Next slide please. Now let me provide an operational update of the LEQEMBI launch since the Accelerated Approval. On January 6, immediately after the Accelerated Approval, our Patient Assistance Program, or PAP was launched through the Eisai patient support start with patient navigators. Uninsured or underinsured individuals, including Medicare beneficiaries, who meet certain financial and other program criteria could be eligible to receive LEQEMBI at no cost under the PAP.
I’m glad to report that prescriptions have already been written for approved PAP patients. Commercial product availability of LEQEMBI was achieved ahead of schedule with a first batch of vials arriving at the warehouse on January 17. On January 18, first sales were recorded when the vials were shipped to various specialty distributors based on their first orders. To our knowledge, on January 23, the first prescription was written. And on February 3, the first infusion on the first patient occurred.
At this moment, prescriptions and infusions have been for individuals under the PAP or paying cash. While our primary goal during the accelerated approval launch phase is to ensure market readiness for LEQEMBI upon full traditional approval and upon broad and simple access. In the meantime, we will make every effort to support health care providers and patients for those who are able to access LEQEMBI.
On January 25, we are very proud that our proactive ARIA education program called understanding ARIA went live. In addition to self directed educational modules, peer-to-peer interactive training and case reviews will be available in partnership with medical imaging experts and academic societies. Overall, what I can say is that the initial LEQEMBI launch, post accelerated approval has been smooth and very much on track.
Next slide please. Eisai’s commitment to supporting the patient journey of Alzheimer’s disease does not stop with the Accelerated Approval of LEQEMBI or the positive Clarity AD result. The graph on this slide depicts a progression of Alzheimer’s disease based on biomarkers as well as cognitive [ph] decline. In the middle of this graph for MCI due to AD and mild AD dementia, the subcutaneous auto injection formulations of lecanemab is under development with a sub study in the Clarity AD open-label expansion, and we expect the file for approval before the end of fiscal year 2023.
In addition, we are also progressing the maintenance dosing regimen of less frequent dosing for lecanemab with a sub study in Study 201 open-label extension and we also expect the [indiscernible] for approval before the end of fiscal year 2023. Let’s go earlier to the left hand side on this slide into the asymptomatic preclinical Alzheimer’s disease stage. The AHEAD 3-45 Phase III study for lecanemab continues to grow with A45 cohort enrolling individuals who are amyloid positive and the A3 cohort enrolling individuals who have intermediate amyloid.
Now let’s go to the right hand side into the later part of the Alzheimer’s disease progression into the mild to moderate AD dementia. You’ll see that our anti-MTBR tau antibody, E2814, which targets extracellular propagation of tau [indiscernible] in the AD brain is in a Phase Ib/II study in DIAD subjects, dominantly inherited Alzheimer’s disease subjects. We believe E2814 specifically targets a disease progression in Alzheimer’s disease in terms of both early tau pathology and late tau pathology. And we very much look forward to the readout of the biomarker results later on this year.
Last but not least, back to the middle part of this graph is a DIAN-TU tau NexGen Phase II/III study, which studies lecanemab and E2814 in combination. This is the first combination of this sort. And we believe this combination approach holds tremendous potential going forward, and is crucial to Eisai’s aspiration to moving closer to one day stopping the progression of this disease altogether, instead of slowing down a disease.
Next slide please. This is my last slide. The FDA accelerated approval of LEQEMBI, first in the world opened a new page, a new page for Eisai, the AD community and society at large. The fundamental strategic mission of a modern pharmaceutical business are in the vision and access for which we will put forth our maximum effort from everyone in Eisai to ensure the realization. Thank you so very much for joining us today.
Unidentified Company Representative
We would like to receive questions. Now the Q&A session is open. First, we’d love to receive questions from the audience in this venue. And then we would like to receive questions from those who are participating online. If you wish to ask a question, please utilize microphone and state your name and affiliation before asking one question. If you have any questions, please raise your hand. The gentleman in the third row, please.
Question-and-Answer Session
Q – Unidentified Analyst
To ask a question in Japanese. This is the first time I am seeing you, Mr. Ivan Cheung in face-to-face manner. I was glad to hear your presentation directly. First, in the [indiscernible] newspaper this morning, there was a report about LEQEMBI. An analyst made a comment on the sales prediction between JPY400 billion to JPY500 billion as the sales of LEQEMBI forecasted. And I thought that this is rather small. But according to the presentation that you have made today, perhaps the reimbursement or insurance coverage will become quite broad. So I would like to ask you what size or scale of sales are you projecting annually? Let’s say in 2030, in 7 years from today, how much sales are you projecting with LEQEMBI?
Ivan Cheung
Thank you very much for very important question. Let’s go country by country. So for the United States, as you may remember, on January 6, when we released our U.S pricing approach, we estimated that in 3 years, potentially about 100,000 patients could be eligible for a treatment like LEQEMBI. And going forward beyond 3 years, 5 years 10 years, the market will continue to expand upon important market expansion catalysts such as why the adoption of blood tests. That’s the United States.
And of course, you can see similar picture in other key markets in Japan, in China. In Europe. We believe this is a gradual adoption upon a number of important developments, such as, as I mentioned earlier, wide adoption for blood tests. And you heard in my presentation earlier, the subcutaneous or the injection formulation. So I think, first and foremost, we have to look at the total potential for LEQEMBI not only in the United States and Japan also, but also around the world. I think that’s one key point.
Another key point is beyond the early AD stage, we’re working very, very intensely for LEQEMBI also into the asymptomatic preclinical AD stage as well as the combination with E2814. So I may not be able to provide an exact figure today. But as you can tell, there are a lot of potential areas we ought to look at in terms of within each key market, across many markets around the globe, and also across a disease continuum expanding beyond that early AD. Thank you.
Unidentified Analyst
Could you be more specific? Could you give me figures like [indiscernible]?
Ivan Cheung
I think many of us in Eisai, including myself, would believe that the number you quoted earlier, maybe too small. Now, I think at Eisai, we prefer to take actions than talking too much. That’s why I tend not to say too much, because I think actions are more important. But I agree with you and many of us agree with you that given the significant potential of how LEQEMBI can help so many patients and families, we believe that number needs to be further improved upon. Thank you. Thank you [indiscernible].
Unidentified Analyst
May I ask one more question. And I just would like to know the situation in China. I think that the system is very different from that to western countries. And your slide says that Eisai submitted all data of Phase III to the Chinese [indiscernible] and you are waiting for the day of approval or so, could you explain the background of Chinese approval system and how soon do you expect — you to get the day of the approval in China.
Ivan Cheung
Thank you. I will ask Ms. Nakahama to [indiscernible].
Unidentified Company Representative
Regarding this question, Nakahama [indiscernible] is going to respond.
Akiko Nakahama
Thank you very much for your question. Regarding the submission we made in China, first, the submission of data has been initiated based upon the global data and from Clarity AD study where Chinese patients were enrolled. So data from Chinese subjects are going to be submitted going forward. Regarding the timing before we can get approval is by the end of next fiscal year. We are aiming at getting approval and this is about the regulatory matters. Therefore we like to try our best in order to get approval as soon as possible. Thank you very much.
Unidentified Company Representative
Next question, please. If you have a question, please raise your hand. Is there anyone in this room who has a question? Then turning to participants who are participating online. If you have questions, please indicate by raise hand button on the Zoom. And once called upon, please unmute and state your question, please. I see hand. Mr. Yamaguchi from Citigroup Securities, please.
Hidemaru Yamaguchi
Can you hear me? Can you hear me?
Tatsuyuki Yasuno
Yes, we can. Please start.
Hidemaru Yamaguchi
Thank you. First question is about Priority Review in Japan. The timing, I was listening to Mr. Ivan Cheung. Did you say the middle of the year? Currently it is February. So around June you expect approval? Is that what you indicated? That is my first question. And regarding the United States, around the summer, I believe is what you’ve mentioned. But this is immediately after submission. So I don’t think you know the PDUFA date. Basically what is the timeline you anticipate, 6 months after submission. If you know the PDUFA date, please indicate that as well.
Tatsuyuki Yasuno
Regarding expected approval timing in Japan, Ms. Nakahama will respond.
Akiko Nakahama
I’m Nakahama, responsible for this product. Thank you for your question. In Japan, Priority Review designation products on average go through 9 months of review. Over the prior review system, some of the submission materials already provided to PMDA for their review since last year. And we would like to assist our expeditious review so that even by one day earlier lecanemab will be accessible to patients, and we will make our best efforts. Earlier. Mr. Ivan Cheung said, middle of the year. Next about the U.S approval timing, Mr. Cheung will respond.
Ivan Cheung
Follow-up to Nakaham’s response to you, earlier I said in the middle of fiscal year 2023.
Hidemaru Yamaguchi
Thank you.
Ivan Cheung
Fiscal Year 2023. So that’s why, as you heard from Nakahama [indiscernible] a 9-month review process, we hope to be a bit earlier. So we’ll see how that pans out and the Eisai team is working day and night on this matter. With regard to the United States, we do not have the PDUFA action date yet on the supplemental BLA as you know very well. For supplemental BLA, as I mentioned earlier, if we get a Priority Review, again, we don’t know yet. This is a 6-month process. That’s why I said in the summer of this year, only a few months away potentially.
Hidemaru Yamaguchi
Finally I’ve I have one more question. So in CMS comment, use the word would. So PDUFA on the same day, does PDUFA coverage may be expanded on the same day. Is that the correct understanding?
Ivan Cheung
That is what the CMS said on January 6 in their public statement, and we commend the CMS proactive statement and the Eisai team is continuing to work and discuss productively with the CMS on multiple with regard to the three questions in the NCD policy. So we are on track and we look forward to that positive outcome on that same day.
Hidemaru Yamaguchi
Thank you. Thank you very much.
Akiko Nakahama
Earlier regarding the question from Mr. Shimoyama [ph], regarding ADD MT [ph], the potential population of the eligible patients we are estimating 2.3 million in 10 years from today. That was announced in the press conference which was held the other day. This is the supplemental follow-up comment for your question.
Unidentified Company Representative
Next, I would like to receive question from Nomura Securities, Mr. Kohtani. Mr. Kohtani of Nomura Securities, the floor is yours. Mr. Kohtani of Nomura Securities, can you hear us?
Motoya Kohtani
Yes.
Unidentified Company Representative
Can you hear me?
Motoya Kohtani
Yes.
Unidentified Company Representative
Please ask your question now.
Motoya Kohtani
First question, regarding amyloid beta diagnostics, can you please elaborate on how this is diagnosed. With ADUHELM [indiscernible] different. And I think CSF the diagnosis has been already approved for two companies. But I don’t think that the PET diagnostic is approved. And I think that the agreement for covering the expenses to be paid by Biogen and Eisai for ADUHELM, but it doesn’t seem that there is one. So could you please elaborate on what is your expectation for the PET diagnosis?
And in CDR-SB is not penetrating into clinics in the United States. And I think the education is necessary. I think the brain battery, I believe that you have the diagnostics of battery CDR-SB and also Alzheimer’s disease symptomatic diagnosis, CBB [ph] penetration as well. Could you please make comment on this?
Unidentified Company Representative
For this question, I’d like to ask Mr. Cheung to respond.
Ivan Cheung
On your first question, if you look at the LEQEMBI Accelerated Approval label, it requires amyloid confirmation prior to initiation of treatment. It does not specify which modality. Meaning it could be PET, it could be CSF and very soon, we believe, a blood test. With regard to your question on payment methods, of course, in the United States, PET has an NCD, also, from the CMS. Certain level of PET coverage is to be provided by the CMS, but not to the extent, of course, as stakeholders would like to see and this is also an other CD — this is also another NCD under consideration by the CMS right now to expand further reimbursement. And Eisai very much supports all the stakeholders that are urging the CMS to expand the reimbursement coverage for PET.
With regard to CSF method in the United States, the process of receiving IVD approval from the FDA, and then subsequently CMS reimbursement, that process is ongoing. And again, we of course, are very much a support as such a development in the United States. In Japan, as you know, with regard to PET, a one very important matter is the expansion of the indication into the MCI due to AD stage, which is also we believe, a very important discussion that the MHLW is taking into consideration right now. And we are very hopeful for a positive outcome when LEQEMBI receives approval in Japan.
So overall, we believe it’s important — very, very important. And we’re doing that Eisai is to work with all the stakeholders involved, the diagnostic companies, academic societies, the payers in different countries to ensure that the diagnostic ecosystem, including reimbursement will be very much in good shape as LEQEMBI receives approvals worldwide. That’s the first part of the question.
Second part of your question with regard to CDR sum of boxes, you are correct. This is an instrument used in clinical trials in the real world. There will be additional efforts on the Eisai’s part to work with providers in different countries on more simplified clinical approaches, those efforts are ongoing and we take your point are very well. Just to note, in real world practice, in addition to CDR sum of boxes, which we do have to figure out how to provide more simplified approaches. Please remember that in the clinic — back in a clinical trial, there are also other scales being used. Can you hear me? Yes, and how those may also translate into real world clinical practices.
You mentioned a cog [ph] state, which is more — which is a cognitive assessment tool. Not used in the clinical trial for endpoint evaluation, we are using — we do believe a CBP [indiscernible] holds a very important role in the ecosystem in terms of screening and screening for our patients in order to allow more individuals to go through amyloid testing. Thank you.
Motoya Kohtani
Second question is [indiscernible] E2814. Could you please — when can we get an update on the clinical trial Phase I study? I think the — DIAD patients were targeted. I think the study is ongoing. And I think this is the open-label, therefore, whenever you like, you’re able to get the data and [indiscernible] is engaged to stop the propagation of tau in the brain. So if there is any such data available, when can we get that data AAIC Academic Conference, or by the end of this year or next year, can we get that data?
Ivan Cheung
Thank you for the question. We will select a medical Congress this year to present the biomarker results tentatively at the AAIC. That’s the plan right now. Thank you.
Motoya Kohtani
Thank you very much.
Unidentified Company Representative
Next, from JPMorgan, Wakao Seiji, please. Mr. Wakao from JPMorgan, can you hear me?
Seiji Wakao
Yes. This is Wakao from JPMorgan. Thank you for taking my question.
Unidentified Company Representative
Yes, please go ahead.
Seiji Wakao
The first question is about the timing of approval in the United States. Could you elaborate on this? PDUFA date will be announced within 60 days of submission, meaning in the beginning of March. Around that time, can we expect some announcement from Eisai? And do you expect something like Advisory Committee?
Unidentified Company Representative
The question will be addressed by Ivan Cheung.
Ivan Cheung
You’re correct. The FDA has 60 days to accept the file and issue the PDUFA action date. And of course, once we have the PDUFA action date, we will probably inform the public. Just want to clarify one point. Since this is a supplemental BLA, that means the 60 days of accepting filing, and I mentioned earlier, if this is a priority review, it’s a 6-month process. That 6 months and the 60 days can occur simultaneously because this is a supplemental BLA which is different from the initial BLA.
And with regard to your second part? Oh, I apologize, Advisory Committee. We’re still waiting for the PDUFA action date. So I think it’s premature to comment on Advisory Committee. One thing I will say is with or without Advisory Committee, I think the Clarity AD data is so robust that whichever approach the FDA chooses to do, our confidence in receiving full traditional approval for LEQEMBI does not change.
Seiji Wakao
Thank you very much. Understood. The second question. Three questions from CMS, a clinically meaningful, side effect issue and long-term efficacy. This in a very abbreviated way, regarding these three questions from CMS, you’ve said that you expect to address with the existing data, data is already shared with CMS. And so CMS is likely to give okay on these three questions, and do you have an inkling of that? I would like to ask you to specifically address these questions.
Unidentified Company Representative
Ivan Cheung, will address your question
Ivan Cheung
On the three key questions in the NCD, as I mentioned earlier, we have already started to supply the answers, meaning the rationale, the evidence, the data and the analysis specific to each question. And I want to clarify that is not just the Phase III Clarity AD data, also the Phase II data. Remember, the Phase II data has open-label long-term extension with data up to 5 years.
One of the three questions from the CMS is how benefits and harms change over time. We obviously from Clarity AD has the 18-month data where you can see the CDR sum of boxes showing statistically significant benefit from 6 months onwards across each time point and across each time point from 6 months to 18 months the benefit expands over time. That’s very important. Benefits expanding over time from 6 months to 18 months.
And then as I mentioned earlier, we have the Phase II plus open-label extension 5 years of data. So I’m not going to go through all the answers to every single question from the CMS NCD document, but we are confident in the provision of our answers to the CMS. Of course, ultimately, this is a CMS decision, but from all the productive interactions we have had with the CMS so far, and also, the FDA is communicating with the CMS on understanding all these data, we are hopeful and we believe the CMS and the FDA ultimately want to do the right thing for the American public and we have utmost respect for both agencies. Thank you.
Seiji Wakao
AD DMT [ph] so much, subject. Globally 2.5 million by 2030 is the estimate. I would like to make correction to the early announced estimated 2.3 million in 10 years. It’s rather 2.5 million by 2030. [Indiscernible] next question after full approval and if others coverage from Medicare, summer — from summer onwards, you will be able to book revenue, book sales, is that the correct understanding? And I do not understand fully how you are going to sell sales reps? I think Eisai will be leading. How are you preparing the sales rep capabilities?
Unidentified Company Representative
Ivan Cheung will address the question.
Ivan Cheung
Thank you for the question. Yes, once we have the Medicare coverage, then 85% of the market in the United States will be able to prescribe this therapy. Right now for those 85% that those are Medicare beneficiaries, even if their physicians want to write a prescription since the government is not paying for it, that market is basically not active and that’s why the CMS coverage will be critically important to open up the market. And yes, Eisai book sales globally, for LEQEMBI. And with regard to the deployment approaches in the field, if you’re asking about the — again, country by country, it’s going to be a different situation. And we have to, of course, tailor our go-to-market model based on the unique characteristics in each market.
In the United States, I believe that’s probably what your question is, yes, Eisai will lead the launch. Right now we are in the accelerated approval launching phase with limited access. So the primary goal right now during this launch phase, this Accelerated Approval launch phase, as I mentioned earlier, is really get the market ready in terms of the diagnostic pathway, the infusion capacity, the education on how to monitor for this therapy, get all the hospitals and clinics ready, so that when full approval and CMS access are available, then these sites will be able to support patients and their families to be on LEQEMBI. I hope, I answered your question.
Seiji Wakao
Thank you very much.
Unidentified Company Representative
Next from Credit Suisse, Mr. Sakai. Mr. Sakai of Credit Suisse. Can you hear us?
Fumiyoshi Sakai
Yes, this is Sakai of Credit Suisse. Can you hear me?
Unidentified Company Representative
Yes, please ask your question.
Fumiyoshi Sakai
I have only one question. According to the presentation, I don’t want it to put the cold water over the presentation where FDA and CMS have put forward a very positive opinion because they are core stakeholders. And I think that this is — this should be taken for granted. But on the other hand, there is such a high expectation towards this drug. I understand that as well. Those people who wanted to have access to this therapy, most important stakeholder, patients, how are they going to be motivated, early stage AD patients, how much subjective symptoms they have. So such patients need to be encouraged to get access to this therapy. I think there should be some measures to be taken. On that regard, what kind of a partnership collaboration, cooperation is being done with Biogen now?
Unidentified Company Representative
Mr. Ivan Cheung is going to respond.
Ivan Cheung
Thank you for the question. You’re correct that especially the MCI due to AD stage, the disease awareness, and the ecosystem development to encourage individuals and their families to be screened for a potential cognitive problems so that they can go to physicians and hospitals for a further follow-up, including confirming the presence of amyloid positivity or not. You’re right. And that is going to be a very important part of our strategy to drive adoptions of LEQEMBI going forward. This is going to be a gradual process.
Country by country, we will have to take different approaches. But you can see that, at Eisai, we’ve already been working on the ecosystem approach since a few years ago with a number of partnerships earlier, the [indiscernible] partnership was mentioned. We are also doing a lot of work with different blood test companies right now. There are of course, a lot of works in different countries with patient efficacy groups, because they are the ones with firsthand interactions with a lot of patients and families in local areas.
Last but not least, of course, a lot of efforts underway with physicians and medical institutions in different countries around the world, so there’s no one simple answer. This is a multifaceted, multidimensional approach, country by country, area by area, street by street and that’s what we’re going to be doing. Thank you.
Fumiyoshi Sakai
Thank you very much. Understood.
Unidentified Company Representative
Fortunately, we are almost running out of time, but I see four people in the queue for questions. So if I may ask each one to limit the number of question to one and quickly please. [Indiscernible].
Unidentified Analyst
Can you hear me? My apologies. I had two questions, but I will ask one question. I believe prevention will be a greater focus after the approval of LEQEMBI, AHEAD 3-45, I do not know how correctly to pronounce this study. When did this study start and when is the readout expected? I understand this is a Phase III study. And in relation to this in terms of insurance coverage, since this target is preclinical AD, it will be targeting asymptomatic patients. And so clinical significance will be appreciated by CMS, is Eisai able to persuade CMS in terms of clinical significance?
Unidentified Company Representative
Ivan Cheung will address the question.
Ivan Cheung
This study started approximately 2 years ago. We will have read out in a couple of years. This is still under enrollment. We’re in the middle of enrollment right now. We’re very encouraged by this study. This study enrolls 1,000 people in the A45 cohort and 400 people in the A3 cohort.
With regard to your second part of the question about coverage by the CMS, I think in a couple of years time, the NCD may or may not look like it is today. So I’m very hopeful that in a couple of years that the clinical — the strong clinical relevance of LEQEMBI will be well established at that point among all stakeholders, including the CMS in the United States, so that coverage and reimbursement won’t be an issue when we have positive outcome from AHEAD 3-45. Thank you.
Unidentified Company Representative
[Indiscernible] Jefferies Securities. Mr. [indiscernible] of Jefferies Securities, can you hear us?
Unidentified Analyst
Yes, I can. I’ve one question from me for Ivan. I was — thank you for Slide 8. The excerpt from the statement from CMS. I was looking at the entire statement and it says that they will generally issue a proposed NCD within 6 months from the initiation of the NCD analysis. Has the formal NCD analysis be done?
Unidentified Company Representative
Mr. Ivan is going to respond.
Ivan Cheung
See if I understand your question. To reconsider the entire NCD, it will take months. You’re right. What you’re hearing from the CMS right now, for example, on this slide is what they may do within the existing NCD framework. And we believe within the existing NCD framework, the LEQEMBI dataset from Phase III, Phase II, open-label long-term extension data, fully answered those three key questions for the CMS to provide [indiscernible] and simple access within the current NCD construct. That’s the point I want to convey. And I think that’s what the CMS is trying to convey from their statement.
Unidentified Analyst
Understood. Thank you very much.
Unidentified Company Representative
Next, [indiscernible] from Sanford Bernstein. Can you hear me, [indiscernible]?
Unidentified Analyst
Yes. Thank you for taking my question. This is [indiscernible] speaking. I’ve a question for you for — regarding LEQEMBI. So we understand that currently the treatment with LEQEMBI requires the free treatment as well as on treatment monitoring of ARIA using MRI. I like to understand the insurance coverage of these monitoring the test? And also the impact for the — your estimate of the impact of such coverage for the uptake of the drug? Thank you.
Ivan Cheung
Yes, with regard to MRI monitoring, at least in the United States, we don’t believe that reimbursement situation is an obstacle at this moment, unlike the diagnostic procedures, which are more work will need to be done on the reimbursement front for those procedures. Thank you.
Unidentified Analyst
Thank you.
Unidentified Company Representative
So we are going to receive the last question from [indiscernible], please.
Unidentified Analyst
Can you hear?
Unidentified Company Representative
Yes.
Unidentified Analyst
This is [indiscernible] speaking. I have a question for Mr. Ivan Cheung. On the 18, LEQEMBI was launched in the United States and what about the uptake and ramp up of the sales going so far? Could you please give us your take on the sales ramp up?
Ivan Cheung
Thank you for the question. We are actually quite encouraged by the initial orders from various specialty distributors for LEQEMBI vials. As I mentioned, we also encouraged that already prescriptions have been written, infusions have occurred. Again, of course without Medicare access these prescriptions and these patients right now they’re either PAP patients or a cash paying patient, but again, they occurred very quickly within the first month of the Accelerated Approval. Again, this is not a pill you take. This is an infusion with the dynastic procedure than infusion, even with those steps involved, we have these accomplishments within the first month and actually within the first 2, 3 weeks. So I think everything is very much on track as we expected and when they even see a bit ahead of our expectation. Thank you.
Unidentified Company Representative
We apologize, we have gone overboard with the schedule with our time. And with that, we would like to close today’s earnings announcement session. Thank you very much for participating despite your very busy schedule.
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