Paris, France, 5 July 2016 – GenSight Biologics, a biotechnology company discovering and developing novel gene therapies for neurodegenerative retinal diseases and diseases of the central nervous system, today announced the launch of its initial public offering with the objective of listing its shares for trading on the regulated market of Euronext in Paris.
On 4 July 2016, the Autorité des Marchés Financiers (AMF) approved the prospectus relating to GenSight Biologics’ initial public offering in France by granting visa no. 16-288.
GenSight Biologics is developing two innovative core technology platforms: Mitochondrial Targeting Sequence (MTS), and optogenetics. Out of a large number of potential applications, GenSight Biologics has chosen to initially focus on neurodegenerative retinal diseases. GenSight Biologics’ product candidates GS010, currently in Phase III clinical studies in Europe and in the US, and GS030, are intended to provide patients with a lasting visual functional recovery after a single intravitreal injection administered to each eye.
Bernard Gilly, CEO of GenSight Biologics, commented: “The perspective of an IPO is a major step in the development of the company. We are confident that our innovative gene therapy platforms will allow several blind patients to partially recover their sight. Our gene therapies are designed to address unmet medical needs and the results of our clinical studies, namely for our most advanced product candidate GS010, are really promising. The funds that we intend to raise through this IPO will advance the development of our product candidates towards commercialization.”
GenSight Biologics’ key strengths
A leader in gene therapy for the treatment of neurodegenerative retinal diseases
Through this IPO, GenSight Biologics aims to become the first gene therapy company listed in Europe in 2016, initially targeting the treatment of neurodegenerative retinal diseases and potentially diseases of the central nervous system. 6 million patients suffer from blindness in Europe and North America. GenSight Biologics’ most advanced product candidate, GS010, targets the treatment of Leber’s Hereditary Optic Neuropathy (LHON). The disease affects between 1,400 and 1,500 new patients each year in Europe and in the United States. GenSight Biologics’ second product candidate GS030, aims to treat Retinitis Pigmentosa (RP), the most common inherited cause of blindness in Europe and in North America, with a prevalence of ~300,000 to 400,000 patients.
GenSight Biologics’ most advanced candidate, GS010, could be 2 years away from filing a Marketing Authorization Application in Europe and the US
GS010 targets LHON, a rare maternally inherited mitochondrial disease, characterized by the degeneration of retinal ganglion cells, leading to sudden and irreversible vision loss and eventually to blindness. The disease mainly affects adolescents and young adults. Leveraging the Orphan Drug status in Europe and in the US, GenSight Biologics has initiated two Phase III clinical trials with GS010 which could allow the company to file for a Marketing Authorization Application in 2018. The results from the Phase I/II trial at 48 weeks with GS010 have confirmed the safety and tolerability of the approach. The improvements observed in the visual acuity of patients with an onset of disease of less than 2 years are very encouraging, and confirm the importance of treating patients early in the course of the disease.
Two technology platforms with a strong therapeutic potential in diseases of the central nervous system
GenSight Biologics is developing two core technology platforms: the Mitochondrial Targeting Sequence (MTS) with GS010, and optogenetics with GS030. Beyond the treatment of neurodegenerative retinal diseases addressed today, GenSight Biologics believes its MTS technology could be used in the treatment of other mitochondrial diseases, such as neurodegenerative diseases of the central nervous system (Leigh Syndrome or Amyotrophic Lateral Sclerosis).
An experienced management team, a prestigious international Scientific Advisory Board and a history of proven success in ophthalmology
One of GenSight Biologics’ strongest strategic advantages lays in the complementarity of the collective backgrounds of its scientific and operational teams, leveraging an extensive experience in ophthalmology and gene therapy.
A solid financial structure with the support of specialized institutional investors in biotechnology
GenSight Biologics has a solid financial structure with a net cash position of over €20 million as of April 30, 2016, before receiving the proceeds from the capital increase relating to the IPO. GenSight Biologics benefits from the support of renowned institutional investors specialized in the biotechnology sector such as Novartis Pharma, Abingworth, Versant, Medixci, and FBIMR, which have confirmed their participation in the IPO for a total amount of up to €17.3m, representing 43.3% of the gross amount of the Offering (without exercise of the overallotment option). Bpifrance Participations, as a new investor, has also committed to place a subscription order for up to €12m, representing about 30% of the gross amount of the Offering (without exercise of the overallotment option).
Use of proceeds from the IPO
The IPO is intended to provide GenSight Biologics with additional financial resources required to fund its activities and pursue the development of its technology platforms and product candidates. The proceeds from the offering will finance:
- The clinical development of GS010 in the treatment of LHON up to filing the Marketing Authorization Application in Europe and in the United States ; and
- The clinical development of GS030 with a Phase I/II trial in the treatment of RP.
Terms of the IPO
Structure of the Offering
Distribution of the offered shares will be made in connection with a global placement (the “Offering”) consisting of:
- a public offering in France made by means of an open price offering (the “Open Price Offering” or “OPO”) to retail investors; and
- a global placement (the “Global Placement”) primarily to institutional investors in France and other countries (including the United States) consisting of:
- a private placement in France; and
- an international private placement in various countries (excluding, notably, Japan, Canada and Australia), including the United States under Rule 144A under the Securities Act and outside of the United States under Regulation S under the Securities Act.
Initial offering size
Issue of a maximum of 5,128,205 new shares (based on the low end of the price range) of a nominal value of 0.025 euro each. The existing shares constituting the share capital of the Company before the Offering amount to 13,609,122 shares (on a non-diluted basis).
Up to a maximum of 15% of the number of new shares initially offered, i.e. a maximum of 769,230 additional new shares (based on the low end of the price range) (the “Overallotment Option”). This Overallotment Option may be exercised by Oddo & Cie, on behalf of the underwriter in part or in full until 11 August 2016 (inclusive).
Indicative price rang
Between €7.80 and €9.20 per new share (the “Offering Price”)1.
The price of the new shares offered in connection with the OPO will be equal to the price of the new shares offered in connection with the Global Placement.
1The Offering Price may be fixed outside this range. In the event of an increase in the upper limit, or if the Offering Price is set above the upper limit of the range (initially or, if applicable, as amended), the date on which the OPO closes may be delayed, or a new subscription period may be re-opened, as the case may be, so that there are at least two trading days between the date on which the press release is released advising of such change and the new date on which the OPO will close. Orders issued in connection with the OPO prior to release of the above-described press release will be maintained, unless they are expressly revoked prior to the new closing date of the OPO, inclusive. The Offering Price may be freely fixed below the lower limit of the indicative range of the Offering Price (in the absence of a significant impact on the other characteristics of the Offering).
Gross proceeds from the issuance
Approximately €40 million, which could be increased to approximately €46 million in the event of full exercise of the Overallotment Option.
On an indicative basis, approximately €33.6m, in the event of a reduction of the size of the Offering.
Estimated net proceeds from the issuance
Approximately €37 million, excluding the exercise of the overallotment option that could be increased to approximately €43 million in the event of full exercise of the Overallotment Option.
On an indicative basis, approximately €31m, in the event subscription received represent €33.6m.
Shareholders subscription undertakings
Several investment funds managed by Novartis Pharma, Abingworth, Versant Ventures, Vitavest and FBIMR (Bpifrance), have undertaken to place subscription orders for a total amount of up to €17m, i.e 43% of the gross proceeds of the Offering (excluding the exercise of the Overallotment Option). These subscription orders are intended to be fulfilled in full and on a priority basis, it being understood that they may, however, be reduced in compliance with standard allocation principles (especially where the subscriptions received in connection with the Offering are much greater than the number of offered shares)
Other subscription undertaking by Bpifrance Participations
A fund managed by Bpifrance Participations has also undertaken to place subscription order for a total amount of up to €12m, i.e. 30% of the gross proceeds of the Offering (excluding the exercise of the Overallotment Option).
Lock-up commitments from the Company, the shareholders, founders, managers and employees
- Company: 360 days
- Existing financial shareholders: 180 days for 100%, 360 days for 662/3% and 540 days for 331/3%
- BPI Bpifrance Participations: 180 days for 100%, 360 days for 662/3% and 540 days for 331/3%
- Managers and Officers: 360 days for 100%, 540 days for 662/3%, 720 days for 331/3%
- Employees: 360 days
Oddo & Cie acts as Global Coordinator and Joint Bookrunner. Gilbert Dupont acts as Joint Bookrunner.
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Persons wishing to participate in the OPO must place their orders with a financial intermediary authorized in France no later than July 11, 2016, at 5 p.m. (Paris time) for subscriptions over the counter and 8 p.m. (Paris time) for subscriptions by Internet.
To be taken into consideration, orders issued in connection with the Global Placement must be received by the Managers no later than July 12, 2016, at 12 noon (Paris time) (unless closed early).
GenSight Biologics share identification codes
- Name: GenSight SA
- ISIN code: FR0013183985
- Ticker: SIGHT
- Compartment: Euronext Paris (Compartment C)
- Business segment: 4573 – Biotechnology
Availability of the prospectus
Copies of the French language prospectus relating to the Offering approved by the AMF on 4 July, 2016 under number 16-288 (the “Prospectus”) are available free of charge from GenSight Biologics (74 rue du Faubourg Saint-Antoine, 75012 Paris, France), or on the company’s website (www.gensight- corp.com) and the AMF’s website (www.amf-france.org).
Investors are invited to note the risks relating to business activities described in chapter 4 “Risk Factors” (and in particular to risk factors mentioned under Section 4.1 “Risks Related to the Products, the Market and the Activity of the Group”) in the Registration Document and in section 2 “Risk Factors Relating to the Offering” in the Securities Note.
About GenSight Biologics
GenSight Biologics S.A. is a clinical-stage biotechnology company discovering and developing novel therapies for neurodegenerative retinal diseases and diseases of the central nervous system. GenSight Biologics’ pipeline leverages two core technology platforms, Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from severe degenerative retinal diseases. GenSight Biologics’ lead product candidate, GS010, is in Phase III trials in Leber’s Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible vision loss in teens and young adults. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to offer patients a sustainable functional visual recovery with a single treatment to each eye through an intravitreal injection.
This press release and the information contained herein do not constitute either an offer to sell or purchase, or the solicitation of an offer to sell or purchase, securities of GenSight Biologics S.A. (the “Company”).
No communication and no information in respect of the offering by the Company of its shares may be distributed to the public in any jurisdiction where registration or approval is required. No steps have been taken or will be taken in any jurisdiction outside France where such steps would be required. The offering or subscription of shares may be subject to specific legal or regulatory restrictions in certain jurisdictions. The Company takes no responsibility for any violation of any such restrictions by any person.
This announcement does not, and shall not, in any circumstances, constitute a public offering nor an invitation to the public in connection with any offer. The distribution of this press release may be restricted by law in certain jurisdictions. Persons into whose possession this press release comes are required to inform themselves about and to observe any such restrictions.
This announcement is an advertisement and not a prospectus within the meaning of the Prospectus Directive (as defined below), as implemented in each member State of the European Economic Area.
With respect to the Member States of the European Economic Area other than France (“Member States”), no action has been undertaken or will be undertaken to make an offer to the public of the securities referred to herein requiring a publication of a prospectus in any Member State. As a result, the securities of the Company may not and will not be offered in any Member State except in accordance with the exemptions set forth in Article 3 of the Prospectus Directive.
For the purposes of the provision above, the expression “offer to the public” in relation to any shares of the Company in any Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide to purchase any securities, as the same may be varied in that Member State. The expression “Prospectus Directive” means Directive 2003/71/EC (as amended, including by Directive 2010/73/EU), and includes any relevant implementing measure in the Member State.
This press release may not be distributed, directly or indirectly, in or into the United States. This press release does not constitute an offer of securities for sale nor the solicitation of an offer to purchase securities in the United States or any other jurisdiction where such offer may be restricted. Securities may not be offered or sold in the United States absent registration under the U.S. Securities Act of 1933, as amended (the “Securities Act”) except pursuant to an exemption from, or in a transaction not subject to, the registration requirements thereof. The securities of the Company have not been and will not be registered under the Securities Act, and the Company does not intend to make a public offer of its securities in the United States. Copies of this press release are not being, and should not be distributed in or sent into the United States.
The distribution of this press release (which term shall include any form of communication) is restricted pursuant to Article 21 (restrictions on financial promotion) of Financial Services and Markets Act 2000 (“FMSA”). This press release is directed only at persons who (i) have professional experience in matters relating to investments and fall within Article 19(5) (“investment professionals”) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005, or (ii) are persons falling within Article 49(2)(a) to (d) (“high net worth companies, unincorporated associations etc.”) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 or (iii) are persons to whom this communication may otherwise lawfully be communicated (all such persons in (i), (ii) and (iii) above together being referred to as “Relevant Persons”). This press release must not be acted on or relied on in the United Kingdom by persons who are not Relevant Persons. Any investment or investment activity to which this press release relates is available only in the United Kingdom to Relevant Persons, and will be engaged in only with such persons. Any person other than a Relevant Person may not act or rely on this press release or any provision thereof. Persons distributing this press release must satisfy themselves that it is lawful to do so.
A Prospectus is been prepared (consisting of (i) a document de base and (ii) a note d’opération including the summary of the Prospectus) and will receive visa from the AMF. This Prospectus includes a section describing certain risk factors relating to the company and the offering. This Prospectus will be available on the AMF web site (www.amf-france.org) and on the company’s web site (www.gensight-biologics.com). Potential investors should review the risk factors described in the Prospectus.
This press release may not be distributed, directly or indirectly, in or into the United States, Canada, Australia or Japan.
THE INFORMATION CONTAINED HEREIN IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, JAPAN OR THE UNITED STATES.