GenSight Biologics
Société Anonyme (public limited company) with a share capital of 718,113.53 Euros
74 rue du Faubourg Saint Antoine 75012 Paris
751 164 757 RCS (Trade and Companies Registry) Paris
REPORT OF THE BOARD OF DIRECTORS TO THE COMBINED GENERAL
MEETING OF JUNE 11, 2019
1. Approval of company's financial statements and consolidated financial statement of the year ended 31 December 2018 (first and second resolutions)
We ask you to approve the company's financial statements for the year ended 31 December 2018, showing a loss of (32,188,196) euros, as well as the consolidated financial statements for the year ended 31 December 2018 as presented, showing a loss (group's share) of (33,453,095) euros.
2. Allocation of the profit/loss of the year (third resolution)
The allocation of the profit/loss of our company that we propose to you is in conformity with the law and our statutes.
We propose to allocate the entire loss of the year ended 31 December 2018, and namely the debit amount of (32,188,196) euros, to the carried forward account report, which thus increases its debit amount of (57,581,241) euros to a debit balance of (89,769,437) euros.
In accordance with the provisions of article 243 bis of the General Tax Code, we inform you that there was no dividend or income distribution during the last three fiscal years.
3. Regulated agreements (fourth resolution)
As a preliminary remark, we remind you that only new conventions concluded in the course of the last year, and, where appropriate, at the beginning of the year in progress are submitted to this Meeting.
Please take note of the absence of new convention of the nature referred to in the article L. 225-38 of the Commercial Code.
4. Mandates of statutory and alternate auditors (fifth and sixth resolutions)
We remind you that the mandates of the statutory auditor Deloitte & Associés and the alternate auditor BEAS expire at the end of the next meeting of shareholders called upon to decide regarding the financial statements for the year ended 31 December 2018.
In accordance with the recommendation of the Audit Committee, the Board of Directors proposes to renew the mandate of the statutory auditor Deloitte & Associés, for a period of six years, or until the end of the ordinary annual general meeting to be held in 2025 and called upon to decide regarding the financial statements for the year ended 31 December 2024.
The Audit Committee has confirmed not having been influenced by any third party in its decision and that no contractual clause that would result in restricting its choice was imposed.
5. Mandates of directors (seventh to tenth resolutions)
We remind you that the mandates of the members of the Board of Directors of Ms. Simone Seiter and Bpifrance participations expire at the end of the next general meeting of shareholders .
On the recommendation of the Appointments Committee, we propose that you:
- Renew the director's mandates of Ms. Simone Seiter and of Bpifrance participations for a duration of three years, or until the end of the meeting held in 2022 called upon to decide regarding the financial statements for the year elapsed;
- Appoint Ms. Maritza McIntyre and Sofinnova Partners SAS in quality of directors in addition to the members currently in function, for a duration of three years each, or until the end of the meeting held in 2022 called upon to decide regarding the financial statements for the year elapsed.
Independence and parity
We inform you that the Board of Directors, on the advice of the Appointments Committee, considers that Ms. Simone Seiter and Ms. Maritza McIntyre can be qualified as independent in light of the criteria of independence of the Middlenext Code, retained by the Company as reference code relating to corporate governance. In this regard, it is indicated in particular that they do not have any business relationship with the Group.
This way, if all resolutions submitted to your approval, relating to mandates of Directors, are approved, the Board would be composed of:
- 5 independent members,
- 4 women and 4 men, in accordance with the legal rules.
Expertise, experience, competence
The information concerning the expertise and experience of the candidates, whose renewal is submitted to you, are detailed in the 2018 Annual Financial Report in paragraph 13.1.2.
Concerning the new candidates, you will find below their biographies:
Maritza C. McIntyre, Ph.D. is the President of Advanced Therapies Partners, LLC.
Dr. McIntyre has 20 years of experience in the development, evaluation and regulation of biological and small molecule products within startup biotech firms, the Food and Drug Administration (FDA), and as a consultant. Dr. McIntyre was a product reviewer and ultimately Branch Chief in the Division of Cellular and Gene Therapies at FDA/CBER, where she was actively involved in policy development and liaison activities to stakeholder groups. She has since worked in regulatory affairs and product development at Bavarian Nordic, REGENXBIO, Inc. and NanoCor Therapeutics. She served as Executive Vice President of Regulatory Affairs and Product Development at Bamboo Therapeutics where, as part of the senior management team, she participated in portfolio selection, product development and fundraising that resulted in an initial $50 million finance round and ultimate the sale of the company to Pfizer.
As president of Advanced Therapies Partners LLC, Dr. McIntyre provides strategic regulatory and product development advice to biotech companies, academics, and venture capital firms. She has
proven success in defining development strategies for products with complex regulatory challenges including special designations (orphan, RMAT, pediatric orphan drug designation), endpoint selection, accelerated approval, complete response letters and dispute resolution. She has also been involved in the preparation of some of the first BLA and MAA submissions for gene therapy products to FDA and EMA. She has multidisciplinary experience, including chemistry manufacturing and control (CMC), preclinical, and clinical with a wide range of product types, including novel gene and cell therapy products, vaccines, biological products and small molecules at varied stages of product development.
Through her participation in industry associations, including ASGCT and the Standards Coordinating Body she has continued to contribute to gene therapy regulatory policy development.
Dr. McIntyre received a Ph.D. in virology from the University of Chicago and graduated magna cum laude with an Honors B.S. in biology from Wayne State University.
Cedric Moreau is a Partner at Sofinnova Partners SAS, and will be their permanent representative
Cedric joined Sofinnova Partners in June 2018 and brings 18 years of experience in life sciences investment banking. He brings to the Sofinnova Crossover team his transactional expertise in the biopharma industry, with an extensive network of Key Opinion Leaders (KOLs), bankers and lawyers.
Cedric joined from Oddo BHF where he was Managing Director and Head of Healthcare at the Corporate Finance department. In 2017, Oddo BHF was top ranked in the European biotech equity capital market deals league tables. Prior to this, he was Director at Bryan Garnier & Co where he completed several sizeable cross border transactions. In total, he has managed transactions (IPO/ FOn/ PIPEs) in European healthcare companies totaling around €2bn in value. He is well known to the Sofinnova team having executed several mandates for portfolio companies. Before his corporate finance career, he spent 10 years as a Healthcare Equity Analyst and was several times EXTEL top ranked (awarded for both individual and team performances) at Natixis and Fortis. He was in charge of both listed biotech and pharma companies coverage. He brings to the Crossover team his transactional expertise in the biopharma industry, with an extensive network of Key Opinion Leaders (KOLs), bankers and lawyers.
Cedric holds a Master's in Economics and post-graduate diploma in Finance and Taxation (Sorbonne) and Diploma from the Société Française des Analystes Financiers (SFAF).
6. Non-votingboard members (eleventh and twelfth resolutions)
We recommend that you renew the mandate of Bpifrance Investissement, in quality of non-voting board member, for a duration of three years, expiring at the end of the meeting held in 2022 called upon to decide regarding the financial statements for the year elapsed, in accordance with the provisions of Article 17 VI of the statutes.
Moreover, it is proposed to you to appoint Ms. Audrey Cacaly in replacement of Mr. Laurent Higueret, in quality of non-voting board member, for a duration of three years, expiring at the end of the meeting held in 2022 called upon to decide regarding the financial statements for the year elapsed, in accordance with the provisions of Article 17 VI of the statutes.
7. Say on Pay (thirteenth to sixteenth resolutions)
7.1 Approval of elements of remuneration paid or attributed for the year elapsed to Mr. Michael Wyzga, Chairman of the Board of Directors, and Mr. Bernard Gilly, CEO(thirteenth to fourteenth resolutions)
- Say on pay ex post of the Chairman of the Board of Directors (thirteenth resolution)
We ask you to decide regarding the fixed, variable or exceptional components of the total remuneration and benefits of any kind paid or attributed for the year elapsed to Mr. Michael Wyzga, due to his mandate as Chairman of the Board of Directors, determined in application of remuneration principles and criteria approved by the General Meeting of the 12th of April 2018 in its eleventh resolution of ordinary nature:
Elements of remuneration paid | Amounts | or accounting | Presentation | ||||
or attributed for the year ended | valuation | submitted to | |||||
voting | |||||||
Fixed remuneration | €145,154 | ||||||
(amount paid) | |||||||
Attribution | of | Share | BSA = €20,200 | 10,000 BSA granted by the board of | |||
Subscription Warrants (Bons de | (Accounting valuation) | directors on the 18th of September | |||||
Souscription d'Actions (BSA)) | 2018 on the basis of the | ||||||
authorization of the General | |||||||
Meeting of 12 April 2018 in its 24th | |||||||
resolution. | |||||||
Warrant subscription price: 0.18 € | |||||||
Warrant exercise price: € 5.04 | |||||||
- Say on pay ex post of the CEO (fourteenth resolution)
We ask you to decide regarding the fixed, variable or exceptional components of the total remuneration and benefits in kind paid or attributed for the year elapsed to Mr. Bernard Gilly, due to his mandate as CEO, determined in application of remuneration principles and criteria approved by the General Meeting of the 12th of April 2018 in its twelfth resolution of ordinary nature:
Elements of remuneration paid | Amounts | or | accounting | Presentation | ||||||
or attributed for the year ended | valuation submitted to voting | |||||||||
Fixed remuneration | €365,000 | |||||||||
(amount paid) | ||||||||||
Variable annual remuneration | €127,750 | 70% of the objectives have been | ||||||||
achieved, it being recalled that | ||||||||||
(amount to be paid after | the qualitative objectives are not | |||||||||
approval of the general meeting) | made | public for | reasons | of | ||||||
confidentiality, | and | represent | ||||||||
mainly | operational | milestones | ||||||||
related to the development of | ||||||||||
research | and | development | ||||||||
projects, | the | conduct | of | |||||||
operations | and | the company | ||||||||
development in general. | ||||||||||
Free allocation of shares | Shares = €94,500 | 45,000 free shared granted free | |||||||
(accounting valuation) | by the board of directors on the | ||||||||
18th of September 2018 on the | |||||||||
basis of the authorization of the | |||||||||
General Meeting of the 12th of | |||||||||
April 2018 in its 23th resolution. | |||||||||
The | final | allocation | should | ||||||
intervene no later the on the 18th | |||||||||
of September 2020 subject to a | |||||||||
condition of presence and the | |||||||||
following | performance | ||||||||
conditions: | |||||||||
The | achievement of | the | |||||||
recruitment of 100% of the | |||||||||
patients in the Phase I/II study of | |||||||||
GS030 | (the | Performance | |||||||
Condition 1); | |||||||||
The production of the first PPQ | |||||||||
lot of GS010 (the Performance | |||||||||
Condition 2). | |||||||||
The acquisition period would be | |||||||||
followed | by a | conservation | |||||||
period of one year. | |||||||||
Exceptional remuneration | No amount is submitted to | - | |||||||
voting | |||||||||
Benefits of any kind | €41,268 | Company flat | |||||||
(accounting valuation) | |||||||||
Elements of | remuneration | in | No amount is submitted to | This commitment is described in | |||||
connection with the termination | voting | paragraph 14.1.1.3 of the 2018 | |||||||
Annual Financial Report | |||||||||
Elements of | remuneration | in | No amount is submitted to | This commitment is described in | |||||
connection | with | non- | voting | paragraph 14.1.1.3 of the 2018 | |||||
competition commitments | Annual Financial Report |
7.2 Approval of principles and criteria for the determination, distribution and allocation of fixed, variable and exceptional components of the total remuneration and benefits of any
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Gensight Biologics SA published this content on 21 May 2019 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 21 May 2019 18:42:01 UTC