GenSight Biologics Announces Cash Position and Revenues as of March 31, 2022

PARIS–(BUSINESS WIRE)–Regulatory news:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharmaceutical company specializing in the development and commercialization of innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announces its cash position and revenue as of March 31, 2022.

“ATU’s sustained demand illustrates the medical community’s confidence in LUMEVOQ and the therapeutic benefits it brings to LHON patients. Additionally, the safety and efficacy data we have generated in our clinical trials remain impressive, and we continue to demonstrate the durability of these results even after long-term follow-up with patients,” commented Bernard Gillyco-founder and CEO of GenSight Biologics. “The GenSight team is working tirelessly to ensure that LUMEVOQ is reliably and consistently produced at the scale needed for the upcoming commercial launch. These steps are part of our commitment to provide LHON patients with access to our innovative treatment as soon as possible.”

Cash position as of March 31, 2022

Cash and cash equivalents of GenSight Biologics amounted to €36.0 million as of March 31, 2022, compared to €44.3 million as of December 31, 2021.

Operating cash burn in the first quarter of 2022 mainly reflects the final stages of pharmaceutical development of LUMEVOQ® supporting the marketing authorization application currently under review by the European Medicines Agency (EMA). These were mainly preparatory activities to ensure the preparation of manufacturing for marketing according to Good Manufacturing Practices (GMP) and in particular the production of validation batches. In addition, the Company continued to conduct phase III clinical trials REFLECT and RESTORE (long-term follow-up of patients REVERSE and RESCUE) of LUMEVOQ® in the treatment of Leber’s hereditary optic neuropathy, as well as the Phase I/II PIONEER trial of GS030 in the treatment of retinitis pigmentosa.

“Addressing our manufacturing challenges is our top priority in 2022, and this is where we will focus our efforts and resources in the months ahead,” commented Thomas GidoinCFO of GenSight Biologics. “With a current cash trail through the start of the first quarter of 2023, we are evaluating several non- or as little-dilutive as possible financing options to ensure a successful European commercial launch of LUMEVOQ in 2023.”

Temporary Authorization for Use (ATU) of LUMEVOQ® in France

Additional patients gained early access to treatment with LUMEVOQ® in the first quarter of 2022 under a Temporary Authorization for Use (ATU) approved by the National Agency for the Safety of Medicines (National Medicines Safety Agency or ANSM). LUMEVOQ® treatments will now only resume in early 2023 once PPQ batches become available.

In the first quarter of 2022, the Company recorded revenue from the sale of LUMEVOQ® under an ATU in France for an amount of €3.1 million compared to €3.9 million over the same period in 2021. Retroactive application from July 1st2021, mandatory discounts set by the new Decree on Early Access to Healthcare in France, as well as the periodic review in 2021 of the variable consideration in accordance with IFRS 15, reduced the net price that the Company uses for accounting for the turnover1.2. As a result, recorded revenues were higher in the first quarter of 2021 although the number of patients treated was the same over the same period in 2022.

Number of shares outstanding

As of March 31, 2022, the number of outstanding shares of GenSight Biologics was 46,335,591 common shares.

GenSight will hold its Annual General Meeting of Shareholders on May 25, 2022, at the Company’s registered office in Paris. The meeting will also be streamed live on the GenSight Biologics website.

GenSight Biologics will release its June 30, 2022 interim financial statements and cash position on July 28, 2022.

About GenSight Biologics

GenSight Biologics SA is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two primary technology platforms, mitochondrial targeting sequence (MTS) and optogenetics, to help preserve or restore vision in patients with blinding retinal diseases. GenSight Biologics lead product candidate, LUMEVOQ® (GS010; lenadogene nolparvovec), has been submitted for marketing authorization in Europe for the treatment of Leber hereditary optic neuropathy (LHON), a rare mitochondrial disease primarily affecting adolescents and young adults and causing irreversible blindness . Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be delivered as a single treatment to each eye by intravitreal injection to provide patients with long-lasting functional visual recovery.

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1 The Company has chosen to recognize variable compensation in accordance with IFRS 15 to reflect the uncertainty on the actual net commercial price which will be obtained after negotiation with the French public payer. Any difference with the original ATU price should then be refunded. Variable consideration is valued using an expected value method based on a range of probability-weighted net prices and discounted at the market rate. Further details are provided in sections 7 and 18 of the 2020 Universal Registration Document.

2 Article 78 of the Social Security budget for 2021 (“Social Security Financing Act”, or LFSS) entered into force on July 1, 2021, following the application of Decree 2021-869 in France. The objective was to reform and simplify the various existing protocols for early access to treatment. Temporary user authorizations (“Temporary Use Authorizations”or ATU) are now replaced by Early Access Authorizations (“Early Access Permissions”). One of the main changes impacting the Company’s accounts is the introduction of mandatory discounts set by law according to a progressive scale based on revenue.

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