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MarketScreener Homepage  >  Equities  >  Euronext Paris  >  GenSight Biologics S.A.    SIGHT   FR0013183985

GENSIGHT BIOLOGICS S.A.

(SIGHT)
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GenSight Biologics S A : Securities Note

10/22/2020 | 02:40pm EST

GenSight Biologics S.A.

A limited liability company with a board of directors (société anonyme à conseil d'administration)

incorporated and organized under the laws of France with a share capital of €843,459.05

Registered office: 74, rue du Faubourg Saint-Antoine, 75012 Paris, France

751 164 757 Paris Trade and Companies Register

(the "Company")

Securities Note

This securities note (the "Securities Note") is made available in connection with the admission to listing and trading on the regulated market of Euronext in Paris ("Euronext Paris") of new ordinary shares to be issued by the Company in connection with a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics for an amount of approximately 25 million euros (premium included), representing 5,954,650 new shares at a price of 4.20 euros per share (the "Offering").

This prospectus is composed of a securities note, a summary, a universal registration document and an amendment to the universal registration document.

The universal registration document was filed on April 8, 2020 under number D.20-0271 with the Autorité des marchés financiers (the "AMF") (the "2019 Universal Registration Document").

The amendment to the 2019 Universal Registration Document was filed on October 22, 2020 under number D. 20- 0271-A01 with the AMF (the "Amendment").

This prospectus was approved on October 22, 2020 under number 20-525 by the AMF as competent authority under Regulation (EU) 2017/1129.

The AMF only approves this securities note as meeting the standards of completeness, comprehensibility and consistency imposed by Regulation (EU) 2017/1129.

Such approval should not be considered as an endorsement of the quality of the securities that are the subject of this securities note. Investors should make their own assessment as to the suitability of investing in the securities.

It is effective during a period of 12 months as from its approval, ending on October 22, 2021, and should be completed by a supplement to the prospectus in case of a significant new factor or material mistake or material inaccuracy pursuant to article 23 of Regulation (EU) 2017/1129.

This prospectus (the "Prospectus") approved by the AMF is composed of:

  • the 2019 Universal Registration Document;
  • the Amendment;
  • the half-year financial report as of June 30, 2020 (the "2020 Half-YearFinancial Report");
  • this securities note (the "Securities Note"); and
  • the summary in French of the Prospectus (included in this Securities Note).

Copies of the Prospectus and any supplement thereto may be obtained free of charge from the Company's registered office (74, rue du Faubourg Saint-Antoine, 75012 Paris, France) on the Company's website (www.gensight-biologics.com), as well as on the AMF's website (www.amf-france.org).

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PRELIMINARY NOTE

In the Prospectus, "Company" and "GenSight Biologics" mean GenSight Biologics S.A., a corporation (société anonyme) with a share capital of 843,459.05 euros, with registered office at 74, rue du Faubourg Saint-Antoine, 75012 Paris, France and registered with the Paris Trade and Companies Register under number 751 164 757.

Forward-looking statements

This Prospectus contains statements regarding the prospects and growth strategies of the Company. These statements are sometimes identified by the use of the future or conditional tense, or by the use of forward-looking terms such as "considers", "envisages", "believes", "aims", "expects", "intends", "should", "anticipates", "estimates", "thinks", "wishes" and "might", or, if applicable, the negative form of such terms and similar expressions or similar terminology. Such information is not historical in nature and should not be interpreted as a guarantee of future performance. Such information is based on data, assumptions, and estimates that the Company considers reasonable. Such information is subject to change or modification based on uncertainties in the economic, financial, competitive or regulatory environments. This information is contained in several chapters of the Prospectus and includes statements relating to the Company's intentions, estimates and targets with respect to its markets, strategies, growth, results of operations, financial situation and liquidity. The Company's forward-looking statements speak only as of the date of this Prospectus. Except for any applicable legal or regulatory requirements, the Company expressly declines any obligation to release any updates to any forward-looking statements contained in this Prospectus to reflect any change in its expectations or any change in events, conditions or circumstances, on which any forward-looking statement contained in this Prospectus is based. The Company operates in a competitive and rapidly evolving environment; it is therefore unable to anticipate all risks, uncertainties or other factors that may affect its business, their potential impact on its business or the extent to which the occurrence of a risk or combination of risks could have significantly different results from those set out in any forward-looking statements, it being noted that such forward-looking statements do not constitute a guarantee of actual results.

Information on the Market and Competitive Environment

This Prospectus contains, in particular in Chapter 5, "Business Overview" of the 2019 Universal Registration Document and in Chapter 3 "Business" of the Amendment, information relating to the Company's markets and to its competitive position. The Company believes that the information contained herein in relation to the Company's markets and competitive position is reliable, but the information has not been verified by an independent expert, and the Company cannot guarantee that a third party using different methods to collect, analyze or compute market data would arrive at the same results. Unless otherwise indicated, the information contained in this Prospectus related to market shares and the size of relevant markets are the Company's estimates and are provided for illustrative purposes only.

Risk Factors

Investors should carefully consider the risk factors set forth in Chapter 3, "Risk Factors", of the 2019 Universal Registration Document, in Chapter 2 "Risk Factors" of the Amendment and in Section 2, "Risk Factors", of this Securities Note before making their investment decision. The occurrence of all or any of these risks could have an adverse effect on the Company's business, reputation, results of operation, financial condition or prospects. Furthermore, additional risks that have not yet been identified or that are not considered material by the Company at the date of the approbation of this Prospectus by the AMF could produce adverse effects.

Websites and Hyperlinks

References to any website or the content of any hyperlink contained in this Prospectus do not form a part of this Prospectus.

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TABLE OF CONTENTS

Section

Page

RESUME DU PROSPECTUS

..................................................................................................................... 4

SUMMARY ................................................................................................................................................

11

1. PERSON RESPONSIBLE, THIRD PARTY INFORMATION, EXPERTS' REPORTS AND

COMPETENT AUTHORITY APPROVAL ....................................................................................

18

2.

RISK FACTORS ...........................................................................................................................

19

3.

ESSENTIAL INFORMATION .......................................................................................................

20

4.

INFORMATION CONCERNING THE SECURITIES....................................................................

23

5.

TERMS AND CONDITIONS OF OFFERING ...............................................................................

35

6.

ADMISSION TO TRADING AND DEALING ARRANGEMENTS................................................

40

7.

SELLING SECURITIES HOLDERS .............................................................................................

40

8.

EXPENSES RELATED TO THE OFFERING ..............................................................................

41

9.

DILUTION .....................................................................................................................................

41

10.

ADDITIONAL INFORMATION .....................................................................................................

43

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RESUME DU PROSPECTUS

Section 1 - Introduction

Nom et codes internationaux d'identification des valeurs mobilières (codes ISIN)

Libellé des actions : GenSight Biologics

Code ISIN : FR0013183985

Identité et coordonnées de l'émetteur, y compris son identifiant d'entité juridique (IEJ)

Dénomination sociale : GenSight Biologics (la « Société », ou « GenSight Biologics »)

Lieu et numéro d'immatriculation : R.C.S. Paris 751 164 757

Identifiant d'Identité Juridique (IEJ) : 549300NK4AB8OUEX1F54

Identité et coordonnées de l'autorité compétente ayant approuvé le Prospectus : Autorité des marchés financiers (l'« AMF ») - 17, place de la Bourse, 75002 Paris, France.

Le Document d'Enregistrement Universel de la Société a été déposé auprès de l'AMF le 8 Avril 2020 sous le numéro n° D.20-0271. L'Amendement a été déposé auprès de l'AMF le 22 octobre 2020 sous le numéro n° D. 20-0271-A01.

Date d'approbation du Prospectus : 22 octobre 2020

Avertissement au lecteur : Le présent résumé doit être lu comme une introduction au prospectus (le « Prospectus »). Toute décision d'investir dans les titres financiers dont l'admission aux négociations sur un marché réglementé est demandée doit être fondée sur un examen exhaustif du Prospectus par l'investisseur. L'investisseur pourrait perdre la totalité ou une partie des sommes qu'il investirait dans les actions de la Société dans le cas d'une baisse du cours des actions de la Société. Lorsqu'une action concernant l'information contenue dans le Prospectus est intentée devant un tribunal, l'investisseur plaignant peut, selon la législation nationale des États membres de l'Union européenne ou parties à l'accord sur l'Espace Economique Européen (l'« EEE »), avoir à supporter les frais de traduction du Prospectus avant le début de la procédure judiciaire. Les personnes qui ont présenté le présent résumé, y compris sa traduction, n'engagent leur responsabilité civile que si le contenu du présent résumé est trompeur, inexact ou incohérent, lu en combinaison avec les autres parties du Prospectus, ou s'il ne fournit pas, lu en combinaison avec les autres parties du Prospectus, les informations clés permettant d'aider les investisseurs lorsqu'ils envisagent d'investir dans ces valeurs mobilières.

L'information faisant l'objet du présent Prospectus permet de maintenir, et rétablir, le cas échéant, en tous points significatifs et en tant que de besoin, l'égalité d'accès entre les différents actionnaires et investisseurs à l'information relative à la Société.

Section 2 - Informations clés sur l'Emetteur

2.1 Qui est l'émetteur des valeurs mobilières ?

  • Dénomination sociale : GenSight Biologics
  • Siège social : 74, rue du Faubourg Saint-Antoine, 75012, Paris, France
  • Forme juridique : société anonyme
  • IEJ : 549300NK4AB8OUEX1F54
  • Droit applicable : droit français
  • Pays d'origine : France

Principales activités

GenSight Biologics est une société biopharmaceutique de stade clinique dédiée au développement et à la commercialisation de thérapies géniques innovantes pour le traitement des maladies neurodégénératives de la rétine et du système nerveux central. Le portefeuille de recherche de GenSight Biologics s'appuie sur deux plates-formes technologiques : le ciblage mitochondrial (Mitochondrial Targeting Sequence, ou MTS) et l'optogénétique, visant à préserver ou restaurer la vision chez les patients atteints de maladies neurodégénératives de la rétine. En utilisant son approche de thérapie génique, les candidats médicaments de GenSight Biologics sont destinés à offrir aux patients une récupération

visuelle fonctionnelle durable après une seule injection intra-vitréenne dans chaque œil. Le candidat médicament le plus avancé de la Société, LUMEVOQ®, pour le traitement de la neuropathie optique héréditaire de Leber (NOHL), une maladie mitochondriale rare qui conduit à une perte irréversible de la vue chez les adolescents et les jeunes adultes, et qui causerait la cécité visuelle chez environ 400 à 550 et environ 1 000 personnes par an aux Etats-Unis et dans l'Union Européenne, respectivement, a fait l'objet d'une soumission d'une demande d'Autorisation de Mise sur le Marché (AMM) européenne en septembre 2020 et est maintenant en phase d'enregistrement auprès de l'European Medicine Agency (EMA) (décision attendue au second semestre 2021).

Les résultats des essais cliniques de phase III REVERSE (en avril 2018) et RESCUE (en février 2019) démontrent une récupération cliniquement significative de l'acuité visuelle et une innocuité soutenues 96 semaines après une seule injection dans un œil, et une nette supériorité sur l'histoire naturelle publiée (définie comme l'évolution naturelle des patients non traités). Une troisième étude de phase III avec le LUMEVOQ®, REFLECT, est en cours et la Société s'attend à recevoir les résultats préliminaires à 78 semaines au cours du deuxième trimestre 2021 dans le cadre d'un protocole d'évaluation spécial (Special Protocol Assessment) avec la Food and Drug Administration (FDA). Une autre étude, REALITY, a

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This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Gensight Biologics SA published this content on 22 October 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 October 2020 18:39:01 UTC


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Financials
Sales 2020 12,5 M 15,0 M 15,0 M
Net income 2020 -16,7 M -20,1 M -20,1 M
Net cash 2020 16,7 M 20,2 M 20,2 M
P/E ratio 2020 -12,3x
Yield 2020 -
Capitalization 290 M 349 M 350 M
EV / Sales 2020 21,9x
EV / Sales 2021 18,9x
Nbr of Employees 25
Free-Float 95,4%
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Technical analysis trends GENSIGHT BIOLOGICS S.A.
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TrendsBullishBullishBullish
Income Statement Evolution
Consensus
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Mean consensus BUY
Number of Analysts 3
Average target price 10,23 €
Last Close Price 7,32 €
Spread / Highest target 91,3%
Spread / Average Target 39,8%
Spread / Lowest Target -8,47%
EPS Revisions
Managers
NameTitle
Bernard Jacques Alex Gilly Chief Executive Officer & Director
Michael S. Wyzga Chairman
Thomas Gidoin Chief Financial Officer
Magali Taiel Chief Medical Officer
José-Alain Sahel Director
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