GenSight Biologics Report 2021 Consolidated Financial Results

  • Strong demand for LUMEVO QATU® In France, despite the COVID situation, it generated € 5.3 million in revenue in 2021. + 20.1% vs. 2020

  • Launch of marketing activities and investment in preparation for the commercial launch of LUMEVOQ® In Europe in 2023

  • Financing period confirmed at the beginning of the first quarter of 2023

Paris – (Business Wire) – Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME Eligible) is a biopharmaceutical company specializing in the development and commercialization of innovative gene therapies for neurodegenerative diseases of the retina and central nervous system today. The 2021 fiscal year approved by the Board of Directors on April 7, 2022. The audit procedure for the 2021 consolidated financial statements was carried out by the statutory auditor. The certification report will be issued after completing the necessary procedures to submit the Universal Registration Document to Autorité des Marchés Financiers.

“We are currently focusing our efforts and resources on addressing production challenges while developing the GS030 at the forefront of optogenetic therapy in preparation for the commercial launch of LUMEVOQ.” 1 comment Thomas GuidoinDirector of Management and Finance of GenSight Biologics. “There are funding prospects at the beginning of the first quarter of 2023, and some funding options that are as undiluted as possible to ensure the successful commercial launch of LUMEVOQ in 2023 in Europe. I’m considering it. “

Consolidated financial statements 2021 (IFRS)

Millions of euros

2020

2021

Operational products

7.4 7.4

7.7

R & D expenses

(22.4)

(22.9)

Selling, marketing and marketing expenses

(2.0)

(5.5)

overhead

(8.0)

(7.4)

Operating income

(24.9)

(28.1)

Revenue

(9.1)

(0.5)

Net income

(34.0)

(28.6)

Profit per share (Euro per share)

(0.97)

(0.63)

Cash flow from operating activities

(15.0)

(17.1)

Net cash flow from investing activities

(0.4)

(0.0)

Net cash flow from financial activities

33.9

23.7

(Decrease) / Increase in cash

18.4

6.6

Cash and cash equivalents at the time of settlement

37.9

44.3

Operational products In 2021, it increased by 3.6% to 7.7 million euros, compared to 7.4 million euros in 2020. This growth is primarily related to the sales generated by LUMEVOQ.® (GS010) Based on the temporary license (nominal ATU) granted by the National Institute of Health Sciences. This sales increased by 20.1% in 2021 to € 5.3 million, compared with € 4.4 million in the previous year. We also recorded a research tax credit (CIR) of € 2.4 million in 2021, compared to € 2.8 million in 2020.

R & D expenses It was stable year-on-year, at € 22.9 million in 2021, compared to € 22.4 million in 2020. For LUMEVOQ Phase III trials® – RESCUE, REVERSE, REFLECT – have been completed and the patient has transitioned to long-term follow-up. We continue to engage in CMC and production activities to ensure our ability to produce and sell in good manufacturing practice. Creating validation batches required to apply for (BPF, or GMP in English), especially LUMEVOQ Marketing Authorization (AMM)® In Europe.

Selling, marketing and marketing expenses Significantly increased to € 5.5 million in 2021 compared to € 2 million in 2020, reflecting the launch of key strategic marketing and market access activities in preparation for the commercial launch of LUMEVOQ. ..® It is planned for 2023 in Europe.

Overhead costs In 2021, it decreased by 7.4% to € 7.4 million, compared to € 8 million in 2020. This decline is primarily related to the reversal of social cost reserves from the 2020 Free Share Grant. Within the time limit.

Operational loss Part of the company was included in 2021 and was € 28.1 million, compared to € 24.9 million in 2020. This 12.8% increase is primarily related to higher sales and marketing costs in preparation for the commercial launch of LUMEVOQ.® It is planned for 2023 in Europe.

Economic loss In 2021, it reached € 500,000, compared to € 9.1 million in 2020. The latter in 2020 consisted primarily of fluctuations in the fair value of derivative financial instruments related to conversion options and equity warrants associated with bond lending with Creos. December 31, 2019 and 2020. Recognized in profit or loss according to IFRS9. The relevant non-cash financial costs of € 7.4 million in 2020 were primarily due to the rise in stock prices during the period.

Net loss Our loss in 2021 was € 28.6 million, compared to € 34.0 million in 2020. The weighted average number of issued shares increased from 35.1 million shares in 2020 to 45.2 million shares in 2021, and the loss per share decreased by 34.5%. The 2021 (0.63) euro compared to the 2020 (0.97) euro. Recalculating the non-cash costs associated with payments under the Equity (IFRS2) and Creos Agreement (IFRS9), the adjusted net loss was € 24.0 million in 2021. , Compared to 22.5 million euros in 2020.

Cash flow from operating activities In 2021, it decreased to (17.1) million euros from (15.0) million euros in the previous year, mainly due to the introduction of commercial infrastructure and preparations for the launch of LUMEVOQ.® In Europe, it was partially offset by the revenue generated by LUMEVO QATU® In France.

Net cash flow from investing activities It reached (16) thousand euros in 2021 compared to (0.4) million euros in 2020, mainly reflecting the activities of our liquidity contracts.

Net cash flow from financial activities The total amount in 2021 is 23.7 million euros, which reflects the net income of 28.1 million euros from a private placement in March, but is partially offset by the amortization of loans guaranteed by the state (PGE) and the issuance of bonds with Creos. Was done. These funding activities in 2020 amounted to € 33.9 million, reflecting a net income of € 23.1 million from a private placement in October 2020, a total of € 6.8 million in PGE and a fixed income loan Tranche B. With Kreos and an amount of 3.9 million euros.

Cash and cash equivalents As of December 31, 2021, it was 44.3 million euros, compared to 37.9 million euros as of December 31, 2020. The amount of expected future cash flows related to the repayment of our financial obligations is € 4.6 million in less than one year and € 12.4 million in more than one year.

GenSight Biologics reports net cash positions and revenues as of April 21, 2022, March 31, 2022.

About GenSight Biologics

GenSight Biologics SA (GenSight Biologics) is a biopharmaceutical company specializing in the development and commercialization of innovative gene therapies for the treatment of neurodegenerative diseases of the retina and central nervous system. The GenSight Biologics research portfolio includes mitochondrial targeting (Mitochondrial targeting sequence, Or MTS) and optogenetics. It is intended to maintain or restore vision in patients with neurodegenerative diseases of the retina. GenSight Biologics drug candidates use its gene therapy approach to provide patients with long-term functional visual recovery after a single intravitreal injection into each eye. Developed for the treatment of Leber’s hereditary optic neuropathy (LHON), LUMEVOQ, GenSight Biologics’ flagship product candidate® (GS010; lenadogene nolparvovec) is currently under consideration for registration in Europe and is being considered in Phase III prior to the application for marketing approval in the United States (GS010; lenadogene nolparvovec).Biologics approval application [BLA]).

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1 See press release April 7, 2022

contact address

GenSight Biologics
Communication director

Clothilde Caillet

[email protected]

Photo 7
Communication and press relations

Julia Friedlander-Most / Romain Grière

[email protected]
+33 (0) 6 83 00 97 55 / +33 (0) 7 86 53 17 29

LifeSci Advisors
Public relations activities for investors

Guillaume van Rentelgem

[email protected]
+41 (0) 76 735 01 31

Orpheon Finance
Private investor

James Palmer

[email protected]
+33 (0) 7 60 92 77 74