TOKYO and CAMBRIDGE, Mass., May 16, 2023 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.
The NDS is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.
Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase II data that demonstrated that lecanemab reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of lecanemab’s clinical benefit in a confirmatory trial. The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.
In the U.S., Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023. On March 3, 2023, the FDA accepted Eisai’s sBLA based on the Clarity AD clinical data, and the lecanemab application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application on June 9, 2023. In Japan, Eisai submitted an application for manufacturing and marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. Priority Review was granted by the Ministry of Health, Labour and Welfare (MHLW) on January 26, 2023. Eisai utilized the PMDA’s prior assessment consultation system, with the aim of shortening the review period for lecanemab. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023, which was accepted on January 26, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022, and Priority Review was granted on February 27, 2023.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
* Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.1
1 Söderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab – Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics (2022). https://doi.org/10.1007/s13311-022-01308-6. Accessed February 9, 2023
Contacts:
Eisai
Biogen Inc.
MEDIA CONTACT: Eisai Co., Ltd. Public Relations Department
TEL: +81 (0)3-3817-5120Eisai Inc. (U.S.) Libby Holman
+ 1-201-753-1945 Libby_Holman@eisai.com
1. About Lecanemab Lecanemab (Brand Name in the U.S.: LEQEMBI™) is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). In the U.S., LEQEMBI was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in Aβ plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
Eisai has completed lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD OLE.
Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. The Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has been ongoing since January 2022.
2. About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
4. About Eisai Co., Ltd. Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter, LinkedIn and Facebook.
5. About Biogen Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.
Biogen Safe Harbor This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Listed Company Name: Eisai Co., Ltd.
Representative: Haruo Naito
Representative Corporate Officer and CEO
Headquarters: 4-6-10 Koishikawa,
Bunkyo-ku, Tokyo
Securities Code: 4523; TSE Prime Market
Inquiries: Sayoko Sasaki
Vice President,
Corporate Communications
Phone +81-3-3817-5120
Eisai Co., Ltd. (Headquarters: Tokyo, Representative Corporate Officer and CEO: Haruo Naito, hereinafter “the Company”) announces that a resolution was adopted to revise the Company’s compensation system (the “System”) for directors and corporate officers at a meeting of the Compensation Committee. In addition, at a meeting of the Board of Directors held today, a resolution was adopted for the disposal of treasury stock in accordance with the revision of the stock compensation plan introduced in 2013. Please refer to “Notification Regarding the Disposal of Treasury Stock through Third-Party Allotment in Accordance with the Revision of the Stock Compensation System,” which was announced today, for details regarding the disposal of treasury stock.
Remarks:
1. Revision of the System The Company has adopted a Nomination Committee, etc. System and the Compensation Committee determines the compensation and related issues with respect to the directors and corporate officers. At the Compensation Committee meeting, the Compensation Committee decided to revise the System as follows:
(1) Directors’ Compensation System
i.Basic concept of the directors’ compensation
The compensation of directors shall be appropriate to enable them to fully perform their duties of management supervision for the common interests of stakeholders and the long-term enhancement of corporate value. Some portion of the compensation of directors shall be paid in the form of shares from the perspective of sharing the same awareness for profits with the shareholders.
ii.Outline of the new compensation system for directors
The compensation of directors shall be only a fixed amount of base salary, but 90% of the base salary shall be paid in cash and 10% shall be delivered in shares (to be delivered upon retirement).
Base compensation levels for both external and internal directors will be oriented toward the mid-to-high end of the industry.
The chairperson of the Board of Directors and the chairpersons of each committee shall be credited with compensation for their services.
(2) Corporate Officers’ Compensation System
I. Basic concept of the corporate officers’ compensation
Compensation for corporate officers shall be competitive and fully reflect the importance and weight of responsibility of the duties assumed. This will contribute to the realization of the hhc philosophy, attract excellent global human talent, and enhance the morale of the corporate officers in performing their duties.
Compensation for corporate officers shall be determined with emphasis on the performance and results obtained as a result of implementing business activities for realizing an hhceco company as stipulated in the Articles of Incorporation. This increases the acceptability as compensation for management.
Compensation for corporate officers shall be based not only on short-term performance based on annual results, but also on strong incentives for corporate officers to enhance the Company’s corporate value, achieve social good, and contribute to social sustainability over the mid- and long-term. In this way, the Company will broadly meet the expectations of stakeholders and contribute to the realization of the Company’s corporate concept.
Compensation for corporate officers shall be determined by setting appropriate performance targets and incentives that balance “risk, return, and impact” (*1), with objective and appropriate evaluation criteria and a transparent and fair process. This will encourage corporate officers to challenge themselves and provide fair and meaningful compensation, as well as accountability to stakeholders.
(*1) risk (active investment of resources in R&D, etc.), return (company-wide financial performance indicators), and impact (social impact of business activities)
ii. Outline of the new compensation system for corporate officers
Compensation for corporate officers shall consist of basic compensation (fixed amount) and performance-related compensation (variable), meaning bonuses and stock-based compensation.
Compensation for corporate officers is set by global job grade (*2) in order to be competitive and reflect the importance and responsibility of the corporate officers’ duties, and the level of compensation is set at the mid-to-high end of the industry.
(*2) A standard that indicates the magnitude of responsibility required for a job and determines compensation.
Performance-related compensation should be set so that the higher the job grade, the higher the percentage of total compensation.
Performance-related compensation shall be structured to fully reflect company-wide performance as management compensation, and the ratio of performance-related compensation to total compensation shall aim to be at least 50%. The performance-related compensation will adopt a system in which the results of the corporate officers’ business execution will be evaluated using new indicators, based on the concept of evaluating the results from the perspectives of risk, return, and impact.
The bonus shall be the sum of the bonus determined based on the degree of achievement of company-wide performance targets (Bonus A) and the bonus determined based on the degree of achievement of individual performance targets (Bonus B), and the ratio of the base amount of calculation between Bonus A and Bonus B shall be 5:5.
The achievement of company-wide performance targets for Bonus A will be determined based on a “risk, return and impact” assessment and will range from 0 to 250%.
The level of achievement of individual performance goals for Bonus B shall be determined based on the evaluation of individual performance goals, including goals related to the realization of the corporate identity stipulated in the Articles of Incorporation, represented by the realization of the social good, and shall be paid in the range of 0 to 150%.
Based on the above, the corporate officers’ bonuses shall range from 0 to 200%.
The Company will introduce a stock-based compensation system that is linked to mid- to long-term business performance and consists of a portion to be granted during service in office and a portion to be granted upon retirement from office. The ratio of the number of shares to be delivered during service and upon retirement will be 7:3. The portion of shares to be delivered during service will be determined based on ESG EBIT, relative PBR and non-financial company-wide performance targets, and will range from 0 to 150%.
2. Revision of the Stock Compensation System Introduced in Fiscal 2013 (the “Stock Compensation System”) and Additional Contribution to the Officers’ Compensation BIP Trust
In response to the revision of the compensation plan, the Company will revise the Stock Compensation System as follows and make additional contributions to the Officers’ Compensation BIP Trust (the “Trust”) introduced in 2013 after changing the Trust period. The details of the revised Stock Compensation System are as follows.
(1) Outline of the Stock Compensation System
The Stock Compensation System is a stock-based compensation system for directors and corporate officers, under which the Company’s shares are acquired through a trust funded by the amount of compensation for directors and corporate officers contributed by the Company, and through which the Company’s shares and money equivalent to the conversion price of the Company’s shares (the “Company’s Shares and Equivalent”) and an amount equivalent to dividends generated by the Company’s shares are delivered and paid (the “Distribution”). The period under the Stock Compensation System shall be three fiscal years from the fiscal year ending on the last day of March 2024 to the fiscal year ending on the last day of March 2026.
(2) Resolution by the Compensation Committee Relating to the Revision of the Stock Compensation System and Resolution of the Board of Directors relating to the Trust
Since the Company has adopted a Nomination Committee System, the compensation of directors and corporate officers is determined through the Compensation Committee. Therefore, the Compensation Committee adopted a resolution to revise the Stock Compensation System and, thereafter, the Board of Directors also adopted the necessary resolutions to determine the amount of money to be contributed to the Trust, the number of shares to be acquired by the Trust, and other necessary matters.
(3) Subjects of the Stock Compensation System (Beneficiary Requirements)
The subjects of the Stock Compensation System are the directors and corporate officers of the Company, and by completing the prescribed procedures to confirm their status as Beneficiaries, they are eligible to receive the Company’s Shares, etc. each July during the Trust Period on the condition that the following Beneficiary requirements have been met:
<Portion to be delivered upon retirement>
a) During the Trust Period, director or corporate officer must be a party to an engagement contract with the Company;
b) Resignation from any of the Company’s directors or corporate officers;
c) The number of shares to be delivered is determined by the Compensation Committee through the calculation formula set forth in (5) below; and
d) Certain acts of misconduct have not been committed.
<Portion to be delivered during service>
a) During the Trust Period, the corporate officer must be a party to an engagement contract with the Company;
b) The corporate officer must not retire or resign from the Company during the term set forth in the Articles of Incorporation;
c) The number of shares to be distributed is determined by the Compensation Committee through the calculation formula set forth in item (5) below; and
d) Certain acts of misconduct have not been committed.
(4) Post-revision Trust Period
The Trust after the revision will be established by amending and adding to the trust currently established under the Stock Compensation System before the Amendment (the “Existing Trust”) for a trust period of three years from August 1, 2023 (scheduled) to the end of July 2026 (scheduled) (the “Post Revision Trust Period”). With respect to the Existing Trust, although the Company’s shares were acquired under the Stock Compensation Plan before the revision, the Company’s shares remaining in the Existing Trust (“Remaining Shares”) and money (“Remaining Money”) shall be utilized during the post-revision trust period, as the period starting from fiscal 2022 will be reduced from three fiscal years to one fiscal year.
At the end of the Trust Period, the Stock Compensation System can be continued by extending the Trust Period and adding trusts, in accordance with a resolution of the Company’s Compensation Committee and Board of Directors.
In the event of such additional trust, any Remaining Shares and Remaining Money in the trust assets at the end of the trust period prior to the extension, if any, shall be succeeded to the Trust to be extended. This extension of the trust period is not limited to a one-time extension, and the trust period can be extended in the same manner thereafter.
(5) Number of Shares to be Distributed to the Directors and the Corporate Officers (including the number of shares subject to conversion to cash)
The number of shares to be distributed to the directors and the corporate officers (including the number of shares subject to conversion to cash) is to be calculated in accordance with the following formulas for the “portion to be delivered upon retirement” and the “portion to be delivered during service in office”. In the event of a stock split or reverse stock split of the Company’s shares, the number of the Company’s shares to be delivered will be adjusted in accordance with the split ratio, reverse stock split ratio, etc.
Directors
< Portion to be delivered upon retirement >
Number of shares to be delivered upon retirement = Base stock compensation amount by director ÷ Base stock price (*3)
Corporate Officers
< Portion to be delivered upon retirement >
Number of shares to be delivered upon retirement = Base stock-based compensation by job grade × 30% ÷ Base stock price (*3)
< Portion to be delivered during service in office >
Number of shares to be delivered during service = Base stock-based compensation by job grade × 70% ÷ Base stock price (*3) x Performance achievement (*4)
(*3) The base stock price shall be the higher of either the average amount (any fraction less than one yen shall be rounded up) of the closing prices (the “Closing Price”) of the Company’s common stock in regular trading on the Tokyo Stock Exchange on each day (excluding days on which no trading is conducted) of the month containing the Additional Trust Date (May 31, 2023 (scheduled)) or the closing price on the Additional Trust Date (if no closing price on that day, the closing price on the immediately preceding trading day)
(*4) Performance achievement is evaluated and determined by the Compensation Committee based on the achievement of the Company’s ESG EBIT, relative PBR and non-financial and other corporate performance targets for each fiscal year. This determines the share delivery ratio for the number of shares to be delivered at the time of the service, which ranges from 0 to 150%.
(6) The Method and Period of the Distribution of the Company’s Shares and Equivalent to the Directors and Corporate Officers
Directors and corporate officers who fulfill the Beneficiary Requirements shall receive, in principle, 50% of the Company’s shares to be delivered, and for the remaining half shall receive payment of the monetary amount equivalent to the shares converted to cash after they are converted within the Trust. The timing for such Distribution is as follows:
< Portion to be delivered upon retirement >
In principle, upon retirement of directors and corporate officers, they shall receive Distribution of the Company’s shares and Equivalent in a number equivalent to the number of shares delivered upon retirement accumulated during their term of office.
< Portion to be delivered during service in office >
In principle, corporate officers shall receive Distribution of the Company’s shares and Equivalent in July every year during the Trust Period.
It is provided that the directors and corporate officers of the Company will continue to hold the Company’s shares they receive by distribution during their term of office and until one year passes after leaving office.
If a director or a corporate officer dies during the Trust Period, in principle, with respect to the number of all of the Company’s shares for which the Distribution, etc. was determined at such time, the heirs of such director or corporate officer shall receive payment from the Trust of the monetary amount equivalent to the shares converted to cash after they are converted within the Trust.
(7) Amount of Trust Money to be Additionally Entrusted to the Trust and the Number of Shares to be Additionally Acquired by the Trust
The amount of trust money to be additionally entrusted to the Trust and the number of shares to be additionally acquired by the Trust shall be calculated as follows.
Amount of trust money to be additionally entrusted to the Trust:
JPY 1,097,910,000 (*)
*The amount of the total of the above additional trust amount and the Residual Money succeeded from the existing BIP Trust will be allocated to the funds for acquiring shares for the Trust, Trust compensation, and Trust expenses.
Number of shares to be additionally acquired by the Trust:
139,000 Shares (*)
*The number of shares of the total of the above number of shares to be additionally acquired by the Trust and the Residual Shares to be succeeded from the existing BIP Trust will be the number of shares of the Company’s Shares and Equivalent, for which the Distribution to Directors and Corporate Officers is expected during the Trust Period of the Trust.
The amount of money to be additionally entrusted to the Trust will be calculated taking into consideration the amount of compensation of the directors and corporate officers as well as the Trust compensation and Trust expenses.
The number of shares to be additionally acquired shall be set to the level required for distributions in the event of the highest attainment of Company-wide performance objectives, with reference to the present stock price level and the present composition of the directors and corporate officers.
(8) The Method of Acquiring the Company’s Shares through the Trust
After extension, the acquisition of the Company’s shares by the Trust is scheduled to be conducted by way of the disposal of the Company’s treasury stock, in accordance with the number of additionally acquired shares and amount of money for the share acquisitions stipulated in item (7) above.
(9) Exercise of Voting Rights with Regard to the Company’s Shares within the Trust
In order to ensure the neutrality of the Trust’s management, the voting rights of the Company’s shares in the Trust are not to be exercised during the Trust Period.
(10) Handling of the Dividends relating to the Company’s Shares within the Trust
In light of the fact that the Distribution of the Company’s shares and Equivalent for retirement portion will be made at the time of retirement, in order to further raise awareness of contribution to sustainable enhancement of corporate value over the mid- to long-term, dividends paid for the Company’s shares in the Trust will be, as well as used for trust fees and trust expenses of the Trust after the Trust receives them, paid to the beneficiaries together with the Company shares and Equivalent for Distribution in proportion to the number of the Company shares for Distribution (including shares to be converted into cash) from the Trust.
(11) Handling of the Trust at its Expiration
If there are any Residual Shares at the expiration of the Trust Period due to Company-wide performance objectives not being attained during the Trust Period or for other reasons, the Trust will continue to be used as the System or an incentive plan similar thereto by extending the trust agreement and making additional trusts. If the Trust will end due to the expiration of the Trust Period, as a means for sharing and boosting the earnings per share for the shareholders, a gratis transfer of such Residual Shares shall be conducted from the Trust to the Company and the Company is scheduled to cancel the Residual Shares in accordance with a resolution of the Board of Directors. Furthermore, the balance of the dividends related to the Company’s shares within the Trust that exist at the expiration of the Trust Period will be utilized as share acquisition funds if the Trust will continue to be used, but if the Trust will be terminated due to the expiration of the Trust Period, the amount that exceeds the Trust expense reserves are expected to be donated to organizations which have no conflict of interest with the Company or the Company’s directors or corporate officers.
【Details of Trust Agreement】
a) Type of trust:
Monetary Trust other than a specified solely administered monetary trust (Third Party Beneficiary Trust)
b) Purpose of trust:
Granting incentives to the directors and corporate officers of the Company
c) Trustor:
The Company
d) Trustee:
Mitsubishi UFJ Trust and Banking Corporation
(Joint Trustee: The Master Trust Bank of Japan, Ltd.)
e) Beneficiaries:
Directors and corporate officers satisfying the requirements to become Beneficiaries
f) Trust Administrator:
A third party having no conflict of interest with the Company (Certified Public Accountant)
g) Trust Agreement Date:
May 29, 2013
h) Trust Period:
From May 29, 2013 to July 31, 2025 (scheduled to be extended until the end of July 2026 by a change to the trust agreement dated May 31, 2023)
i) Post-extension System Commencement Date:
August 1, 2023 (scheduled)
j) Exercise of Voting Rights:
No voting rights shall be exercised
k) Types of Shares Acquired:
Company’s common stock
l) Amount added to the Trust:
JPY 1,097,910,000 (including trust compensation and trust expenses)
m) Share Acquisition Date:
June 5, 2023 (scheduled)
n) Method of acquiring shares:
By way of disposal of the Company’s treasury stock
o) Rights Holder:
The Company
p) Residual Assets:
The residual assets that may be received by the Company, which is the rights holder, shall be within the trust expenses reserves equal to the trust money minus the amount for the share acquisition.
Outline of the Trust
a) Since the Company has adopted a Nomination Committee System, the Compensation Committee first adopted a resolution to revise the Stock Compensation System, and then the Board of Directors adopted a resolution to dispose of treasury stock in accordance with the Stock Compensation System.
b) In continuing the Stock Compensation System, the Company has established the Basic Policy on Distribution of Shares related compensation of directors and corporate officers.
c) The Company will extend the trust period of the trust which will appoint as beneficiaries those directors and corporate officers who meet the beneficiary requirements (such trust hereinafter the “Trust” and such beneficiaries hereinafter the “Beneficiaries”) in accordance with the resolutions of the Compensation Committee and the Board of Directors as described in item a), and thereafter the Company will entrust additional money.
d) In accordance with the instructions of the Trustee, the Trust will receive the allotment of the Company’s shares (disposal of treasury stock) by the money additionally entrusted in accordance with item c) and the money that remains in the existing Trust. The number of shares the Trust is to acquire shall be set by way of resolution of the Board of Directors in accordance with the resolution of the Compensation Committee as described in item a).
e) Distributions of dividends with respect to the Company’s shares within the Trust will be made similar to other shares.
f) Voting rights for the Company’s shares within the Trust shall not be exercised during the Trust Period.
g) During the Trust Period, the directors and corporate officers who meet the beneficiary requirements will receive a certain proportion of the Company’s shares and the monetary amount equivalent to the shares converted to cash that can be obtained by converting a certain proportion of the Company’s shares, based on Company-wide performance attainment for each fiscal year.
h) If there are any residual shares at the expiration of the trust period due to Company-wide performance objectives not being attained during the trust period, etc., the Trust will continue to be used as the Stock Compensation Plan or an incentive plan similar thereto by extending the trust agreement and making additional trusts, or such shares will be transferred, gratis, from the Trust to the Company, and will be cancelled by way of a resolution of the Board of Directors.
i) Upon the termination of the Trust, the residual assets, after the distribution to the Beneficiaries is completed to the extent that trust expense reserves remain after deducting the stock acquisition funds from the trust money, will belong to the Company. In addition, any amount in excess of the trust expense reserves will be donated to organizations which have no conflict of interest with the Company or the Company’s directors or corporate officers.
(Note) If there are no longer any Company’s shares in the Trust due to the distribution of the Company’s shares or payment of the monetary amounts equivalent to the shares converted for cash to directors and corporate officers that meet the Beneficiaries requirements, the Trust will end before the trust period expires. Furthermore, the Company may entrust additional money to the Trust acquire additional Company shares or trust compensation and to meet Trust expenses.
Listed Company Name: Eisai Co., Ltd.
Representative: Haruo Naito
Representative Corporate Officer and CEO
Securities Code: 4523
Stock Exchange Listings: Prime Market of the Tokyo Stock Exchange
Inquiries: Sayoko Sasaki
Vice President
Corporate Communications
Phone +81-3-3817-5120
Eisai Co., Ltd. (“the Company”) announced today that based on trends in business results, etc., the Company has revised its consolidated financial forecasts for the fiscal year ending March 31, 2023 (April 1, 2022 to March 31, 2023) previously announced on November 7, 2022, as follows.
1. Revised consolidated financial forecasts for the fiscal year ending March 31, 2023 (April 1, 2022 to March 31, 2023)
(Unit: Millions of yen, unless otherwise noted.)
Revenue
Operating
profit
Profit before
income taxes
Profit for
the year
Profit attributable to owners of the parent
Basic
earnings
per share
Previously announced forecast (A)
(November 7, 2022)
760,000
55,000
56,500
58,000
57,000
197.80 yen
Currently revised forecast (B)
744,000
40,000
45,000
56,500
55,000
193.30 yen
Change in amount (B – A)
(16,000)
(15,000)
(11,500)
(1,500)
(2,000)
Percentage of change (%)
(2.1%)
(27.3%)
(20.4%)
(2.6%)
(3.5%)
(Reference) Business results for the fiscal year ended March 31, 2022
756,226
53,750
54,458
45,717
47,954
167.27 yen
2. Reason for revision of the consolidated financial forecasts Based on trends in foreign exchange and product sales, revenue is expected to be ¥744.0 billion, a decrease of ¥16.0 billion from the previous forecast (of which approximately ¥9.5 billion is due to foreign exchange fluctuations).
Due to the decrease in gross profit resulting from the decline in revenue (a decrease of approximately ¥9.5 billion from the previous forecast) and the increase in R&D expenses (an increase of ¥6.5 billion from the previous forecast) resulting from aggressive investments with the good progress of clinical trials for Alzheimer’s disease treatment lecanemab and the review of existing development projects, operating profit is expected to be ¥40.0 billion, a decrease of ¥15.0 billion from the previous forecast.
As a result of the decrease in operating profit and other factors, tax expenses are expected to decrease ¥10.0 billion from the previous forecast, profit for the year is expected to be ¥56.5 billion, a decrease of ¥1.5 billion from the previous forecast, and profit attributable to owners of the parent is expected to be ¥55.0 billion, a decrease of ¥2.0 billion from the previous forecast.
The annual dividend forecast remains unchanged at ¥160 per share, with the year-end dividend of \80 per share (same amount as the previous period) together with the interim dividend (end of the second quarter) of \80 per share, as previously forecast.
* Please note that actual business results may change due to several factors since the above-mentioned forecasts were made based on information available as of May 9, 2023.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced the completion of a major renovation of its Tsukuba Research Laboratories (Ibaraki, Japan), which is a part of strategic investment to execute Eisai’s medium-term business plan “EWAY Future & Beyond”.
Eisai implements research and development activities under the DHBL (Deep Human Biology Learning) drug discovery and development system in our efforts to create new drugs based on innovative and efficient next-generation drug discovery concepts. For this purpose, we recognize diseases as Disease Continuum to redefine their concepts through comprehensive analysis on genomic, pathophysiological and clinical information associated with underlying causes of disease in order to enhance our understanding on human biology by acquiring data leading to next drug discovery with information, such as biomarkers and imaging data from patients on our drugs. Tsukuba Research Laboratories is positioned as a core facility in the DHBL drug discovery and development system. This renovation seeks to accelerate knowledge circulation by connecting each researcher with patients, other members within the Laboratories, other research sites across the world, and external researchers based on our key concept “Human Connected Laboratories: Laboratories Connecting Human and Human, and Data, and the World.” Total investment on this major renovation was 8.5 billion yen.
Main Idea of This Major Renovation
[Designs to Enhancing Connection with Patients]
In the Eisai Group, all employees around the world use 1% of their total business hours to interact with patients (socialization) to understand their thoughts and feelings. Accordingly, we have been working on the initiatives (hhc activities) to lead value creation for patients. To enhance the opportunities for closer interaction with people outside the company, such as further socialization with patients, at Tsukuba Research Laboratories, a traffic line from the front gate through the main building lobby to the courtyard is placed as interactive zone to enable various communications.
[Realizing Connections between Researchers and Data Driven Drug Discovery]
In favor of generating natural communication between researchers across different therapeutic areas on a daily basis, workspaces for biology researchers and data scientists are allocated on the same floor, and likewise workspaces for chemistry and pharmacokinetics/analytical researchers are placed on nearby floors to foster new connections and knowledge exchange. Further creative solutions are implemented in laboratories, including collective arrangement of structural openings and devices. These designs facilitate data driven drug discovery through knowledge exchange.
[Knowledge Circulation Generated from Links between Buildings]
Corridors linking multiple buildings embodying the concept of Knowledge Circulation are placed. A traffic line named “Knowledge Corridor” enables people to move all around the laboratory, with which research efficiency and convenience are considerably improved.
[Meeting Rooms Value Connection with the World]
Each meeting room is equipped with an IT environment that allows smooth communication with overseas offices, as well as systems able to deal with hybrid meeting which dominantly accepted in recent days.
Eisai will accelerate the drug discovery activities under the DHBL drug discovery system in order to fulfill unmet medical needs, and in our efforts to further contribute to improve the benefits of patients and the people in the daily living domain.
Media Inquiries: Public Relations Department,
Eisai Co., Ltd. +81-(0)3-3817-5120
[Notes to editors]
1. Outline of Tsukuba Research Laboratories Location: 5-1-3 Tokodai, Tsukuba, Ibaraki
Groundbreaking of the renovation: December 2019
Completion of the renovation: February 2023 (Opening Ceremony: 6 April 2023)
Site area: 86,845.05 m2 Building area: 65,110.78 m2 Total investment on the renovation: 8.5 billion yen
An interactive zone for researchers and people outside company
Treatment with Lecanemab Resulted in a Delay of 2 to 3 Years in the Mean Time to Progression to More Severe Stages of Alzheimer’s Disease, Compared with Standard of Care Alone
Subgroup Analysis Suggested that Earlier Initiation of Treatment with Lecanemab May Have a Greater Impact on Disease Progression
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced an article about long-term health outcomes of anti-amyloid-beta (Aβ) protofibril* antibody lecanemab in people living with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) using simulation modeling was published in the peer-reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of early AD and improving patients’ quality of life.
This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial (Study 201), published in April 2022.
The article compares the long-term clinical outcomes of individuals with early AD and amyloid pathology who received standard of care (SoC) alone (including stable use of acetylcholinesterase inhibitor or memantine) with those who received lecanemab plus SoC (lecanemab+SoC). The analysis is based on a disease simulation model (AD ACE model1) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD. The study showed that the estimated lifetime risk of disease progression to mild, moderate, and severe AD dementia could potentially be reduced by 7.5%, 13.7% and 8.8%, respectively, in patients who received lecanemab+SoC, compared to those who received SoC alone. Moreover, the use of lecanemab allowed approximately 5% of patients to avoid institutional care. Treatment with lecanemab also resulted in a delay of 2 to 3 years in the mean time to progression to more severe stages of AD, compared with SoC alone. The model showed that the mean time to progression to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group compared to those in the SoC group, by 2.71 years (SoC vs. lecanemab+Soc: 2.35 vs.5.06 years), 2.95 (5.69 vs. 8.64 years) and 2.24 (8.46 vs.10.79 years), respectively. In addition, admission to institutional care was delayed by 0.60 years in the lecanemab-treated group compared to SoC alone (SoC vs. lecanemab+Soc: 6.25 years vs. 6.85 years). In terms of quality-adjusted life-years (QALYs)***, patients treated with lecanemab experienced an increase of 0.71 QALYs compared to those receiving SoC, with QALYs for lecanemab-treated patients amounting to 4.39 years. Furthermore, a subgroup analysis by age and disease severity at baseline suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression. The incremental mean times for transition to mild and moderate AD dementia were 2.55 and 3.15 years, respectively, when treating MCI due to AD in a subgroup analysis compared to SoC.
“The outcomes of this simulation quantitatively demonstrate the long-term health outcomes of lecanemab and support the results of the simulation from Study 201. These predicted and simulated long-term health outcomes provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. Treatment with lecanemab may potentially provide a benefit over the current standard of care by delaying the progression of AD and potentially allowing people taking lecanemab to live independently longer, and improve their quality of life,” said Ivan Cheung , Senior Vice President, and Global Alzheimer’s Disease Officer, Eisai Co., Ltd., Chairman and CEO, Eisai Inc. “Eisai will continue to transparently and expeditiously publish data and information about lecanemab to foster meaningful discussions about its clinical and societal value for people and countries around the globe.”
Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that lecanemab reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of lecanemab’s clinical benefit in a confirmatory trial. The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.
In the U.S., Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023. On March 3, 2023, the FDA accepted Eisai’s sBLA based on the Clarity AD clinical data, and the lecanemab application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting. Eisai submitted an application for manufacturing and marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023, in Japan. The Priority Review was granted by the Ministry of Health, Labour and Welfare (MHLW) on January 26, 2023. Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023, which was accepted on January 26, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022, and the Priority Review was granted on February 27, 2023.
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen Inc. co-commercializing and co-promoting the product and Eisai having final decision-making authority.
* Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.2 ** Standard of Care (SoC) for AD currently consists of lifestyle modifications and pharmacologic treatment of symptoms.
*** The quality-adjusted life year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life (i.e., quantity) and quality of life (QOL), the QALY was developed as an attempt to combine the value of these attributes into a single index number. One QALY equates to one year in perfect health. QOL scores range from 1 (full health) to 0 (dead). For example, if a new treatment and an existing treatment both increase survival years by 3 years, but the new treatment maintains a QOL of 0.7 (QALY=2.1), while the existing treatment has a lower QOL of 0.5 (QALY=1.5), the incremental QALY for the new treatment would be 0.6 (QALY = QOL score x survival years).
1 Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer’s disease Archimedes condition-event simulator: Development and validation. Alzheimers & Dementia: Translational Research & Clinical Interventions. 2018;4:76-88. Published 2018 Feb 16. doi:10.1016/j.trci.2018.01.001
2 Söderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab — Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics (2022). https://doi.org/10.1007/s13311-022-01308-6. Accessed February 9, 2023
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
Eisai Europe, Ltd.
(UK, Europe, Australia, New Zealand and Russia)
EMEA Communications Department
+44 (0) 786 601 1272 EMEA-comms@eisai.net
[Notes to editors]
1. About Lecanemab Lecanemab (Brand Name in the U.S.: LEQEMBI™) is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). In the U.S., LEQEMBI was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in Aβ plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
Eisai has completed lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) OLE.
Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen.
Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing.
2. About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
Values are an integral part of our foundation. With every decision, we ensure that we follow:
Integrity
Integrity is the living up to legal, moral and ethical principles in the conduct of HI-Eisai Pharmaceutical Inc. business. It means that each employee embodies the value of integrity, and therefore represents the company in honesty and rectitude in all the ways they do their work.
It is expected that each employee would make decisions guided by good judgement, not just for one‘s self, but for HI-Eisai as the company. An employee who acts with integrity ensures that he has understanding of the principles by which the company operates, and in situations where he lacks clarity, will actively seek guidance.
Respect
The company is committed to ensure that it maintains a safe, inclusive, and healthy working environment that promotes productivity among employees. All employees are expected to show respect to fellow employees, customers, and patients, regardless of differences in gender, culture, backgrounds, and beliefs. Leaders in the organization are likewise expected to promote inclusivity with their teams, and shall not tolerate any discriminatory and offensive actions.
Accountability
Accountability at work means assuming responsibility for the business outcome and how that is achieved. It means that every employee, in whichever position, are equally responsible for the decisions and actions they make for the company. It is likewise, the responsibility of each employee to report, any knowledge of misconduct or potential violation to the company‘s rules and regulations.
Patient-Centric
At the heart of the company‘s operation are the patients. This means that every decision to be made, considers the potential impact and benefit to the patients. As such, the company commits itself in ensuring that business objectives align with its principle of human health care or hhc. The programs created and implemented are based on how well they could contribute to improving patients‘ lives.
For field-based employees, being patient-centric means that the focus of engagements with customers are on understanding patient needs as well as providing these stakeholders with comprehensive information on how HI-Eisai‘s products can support their patients goals.
For each employee, being patient-centric means taking on their responsibilities with care and consideration on how it impacts the patients experience, be it by making relevant information readily available for the doctors; or by ensuring access and availability to the medicines we offer.
Excellence
As a patient-centric company, we define Excellence by the outstanding quality of our work to improve patients‘ lives. Each employee is expected to consistently demonstrate work ethics that align to our values, policies, and our desire to provide above standard service. The company is committed in ensuring that all actions are in compliance with legal requirements.
Being excellent means that every employee passionately strives to be better and participates in the company‘s initiatives to develop their members in terms of knowledge, skills, and behavior, which will support a continuously improving, responsible and performance-driven workforce.
Our Vision
To be a successful and sustainable business in the Philippines by driving innovation and providing solutions to address unmet healthcare needs fueled by high-performing employees who deliver meaningful value and experience to patients and their families.
Our Mission
We give first thought to patients and their families, and to increasing the benefits health care provides.
