{"id":4100,"date":"2023-03-24T06:30:52","date_gmt":"2023-03-24T10:30:52","guid":{"rendered":"https:\/\/www.gensight-biologics.com\/gensight-biologics-publie-ses-resultats-financiers-consolides-pour-lexercice-2022\/"},"modified":"2026-09-24T00:05:53","modified_gmt":"2026-09-24T04:05:53","slug":"gensight-biologics-publie-ses-resultats-financiers-consolides-pour-lexercice-2022","status":"publish","type":"post","link":"https:\/\/www.gensight-biologics.com\/fr\/2023\/03\/24\/gensight-biologics-publie-ses-resultats-financiers-consolides-pour-lexercice-2022\/","title":{"rendered":"GenSight Biologics publie ses r\u00e9sultats financiers consolid\u00e9s pour l\u2019exercice 2022"},"content":{"rendered":"\nParis, France, March 24, 2023, 7:30 am CET<\/strong> \u2013 GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its full year 2022 consolidated financial results, as approved by the Board of Directors on March 23, 2023. Audit procedures on the Company\u2019s 2022 consolidated financial statements were completed by the Company\u2019s statutory auditors. Final certification will take place after the completion of procedures required before the Universal Registration Document is filed with the French market authority (Autorit\u00e9 des March\u00e9s Financiers<\/em>).\n\n \n\n\u201cWe are now focusing our efforts and resources on securing the upcoming LUMEVOQ validation campaign with our manufacturing partner in the US, while discussing a financing bridge with certain existing shareholders to extend the cash runway beyond the results of this campaign expected in Q3 2023,\u201d<\/em> commented Thomas Gidoin<\/strong>, Chief Financial Officer of GenSight Biologics. \u201c<\/em>The combination of this financing bridge targeted to close in the coming weeks and the EIB Tranche B expected in Q3 upon the success of the validation campaign would extend our cash runway to the end of 2023.\u201d<\/em>\n\n \n\nAnnual Consolidated Financial Statements (IFRS) for the Year Ending December 31, 2022 and December 31, 2021<\/strong>\n\n \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
In million euros<\/strong><\/td>\n2021<\/strong><\/td>\n2022<\/strong><\/td>\n<\/tr>\n
Operating income<\/td>\n7.7<\/td>\n4.9<\/td>\n<\/tr>\n
Research and development expenses<\/td>\n(22.9)<\/td>\n(19.3)<\/td>\n<\/tr>\n
Sales and marketing expenses<\/td>\n(5.5)<\/td>\n(8.0)<\/td>\n<\/tr>\n
General and administrative expenses<\/td>\n(7.4)<\/td>\n(5.4)<\/td>\n<\/tr>\n
Operating profit (loss)<\/td>\n(28.1)<\/td>\n(27.8)<\/td>\n<\/tr>\n
Financial profit (loss)<\/td>\n(0.5)<\/td>\n0.2<\/td>\n<\/tr>\n
Net profit (loss)<\/td>\n(28.6)<\/td>\n(27.6)<\/td>\n<\/tr>\n
EPS (in \u20ac per share)<\/td>\n(0.63)<\/td>\n(0.60)<\/td>\n<\/tr>\n
Net cash flows from operating activities<\/td>\n(17.1)<\/td>\n(33.8)<\/td>\n<\/tr>\n
Net cash flows from investing activities<\/td>\n(0.0)<\/td>\n0.2<\/td>\n<\/tr>\n
Net cash flows from financing activities<\/td>\n23.7<\/td>\n0.1<\/td>\n<\/tr>\n
Net cash flows<\/strong><\/td>\n6.6<\/strong><\/td>\n(33.5)<\/strong><\/td>\n<\/tr>\n
Cash and cash equivalents at closing<\/strong><\/td>\n44.3<\/strong><\/td>\n10.6<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \n\n \n\nThe Company\u2019s operating income<\/strong> reduced by 36.9% to \u20ac4.9 million in 2022 from \u20ac7.7 million in 2021. This decrease was essentially driven by a single quarter of revenues generated in 2022 by LUMEVOQ\u00ae<\/sup> in France through the supply of named patient Temporary Authorizations for Use (\u201cATU nominative<\/em>\u201d), compared to a full year of revenues generated in 2021, following manufacturing issues at the Company\u2019s partner leading to all available vials being used up in March 2022. These revenues amounted to \u20ac2.6 million[1]<\/a> in 2022 compared to \u20ac5.3 million a year earlier. The Company expects to resume supply of AAC (Autorisation d\u2019Acc\u00e8s Compassionnel<\/em>, or Early Access Authorisation, former ATU) in France in Q4 2023 as soon as the product becomes available.\n\n \n\nThe Company also generated research tax credit (Cr\u00e9dit d\u2019Imp\u00f4t Recherche<\/em> or CIR), amounting to \u20ac2.2 million in 2022 compared to \u20ac2.4 million in 2021. This evolution stems directly from the end of the clinical development of LUMEVOQ\u00ae<\/sup> towards its pre-commercialization phase for which expenses are not eligible to CIR.\n\n \n\nResearch and development expenses<\/strong> decreased by 15.6% year-on-year amounting to \u20ac19.3 million in 2022 compared to \u20ac22.9 million in 2021. While Phase III clinical trials of LUMEVOQ\u00ae<\/sup> \u2013 RESCUE, REVERSE and REFLECT \u2013 are now completed and patients entered long term follow-up, the Company maintains its efforts in Chemistry, Manufacturing and Controls (CMC) activities to ensure manufacturing readiness to commercialize under Good Manufacturing Practices (GMP) and notably the production of validation batches as required to complete the Marketing Authorisation Application (MAA) of LUMEVOQ\u00ae<\/sup> in Europe.\n\n \n\nThe PIONEER Phase I\/II Clinical trial for GS030 continued throughout 2022 showing a good safety profile and encouraging efficacy signals. The Company is now recruiting an extension cohort at the highest dose.\n\n \n\nSales and marketing expenses <\/strong>sharply increased by 45.3% over the period amounting to \u20ac8.0 million in 2022 from \u20ac5.5 million in 2021 reflecting the ramp up of key strategic marketing and market access activities in preparation for the expected commercial launch of LUMEVOQ\u00ae<\/sup> in Europe in H1 2024. The Company is also building its local presence in the main European countries, France, Germany, the United Kingdom, Italy and Spain by setting up local commercial affiliates.\n\n \n\nGeneral and administrative expenses<\/strong> significantly reduced by 27.7% year-on-year amounting to \u20ac5.4 million in 2022 compared to \u20ac7.4 million in 2021. This decrease was mainly driven by a reversal of share-based payment non-cash expenses, due to the cancellation of performance shares plans whose conditions were not met timely due to the manufacturing issues at the Company\u2019s partner in the United States. The entirety of plans granted in 2020 and 2021 to management were voided in 2021 and 2022.\n\n \n\nThis decrease was partially offset by a significant increase in professional fees, mainly legal fees in the context of financing transactions and strategic opportunities conducted in 2022, as well as communication fees related to corporate communication and investor relations efforts in 2022.\n\n \n\nThe Company\u2019s operating loss<\/strong> was stable in 2022 amounting to \u20ac27.8 million compared to \u20ac28.1 million in 2021. Excluding share-based compensation (IFRS2) non-cash expenses, the adjusted operating loss amounted to \u20ac31.2 million in 2022 compared to \u20ac23.3 in 2021.\n\n \n\nThe financial profit<\/strong> in 2022 amounted to \u20ac0.2 million compared to a loss of \u20ac(0.5) million in 2021. The amount in 2022 was essentially composed of a non-cash financial gain related to the change in derivative financial instrument fair value of the Kreos bond financing, fully repaid in December 2022. This financial gain was offset by interest expenses attached to the Kreos bond and the state-guaranteed loan (Pr\u00eat Garanti par l\u2019\u00c9tat<\/em> or PGE) based on the effective interest rate.\n\n \n\nThe Company also recorded foreign exchange gains and losses primarily driven by the purchase of services denominated in U.S. dollars. The net foreign exchange result in 2022 was a gain of \u20ac0.6 million.\n\n \n\nThe Company\u2019s net loss<\/strong> in 2022 amounted to \u20ac27.6 million compared to \u20ac28.6 million in 2021. The average weighted number of shares increased to 46.3 million in 2022 from 45.2 million in 2021 leading the loss per share to decrease by 5.9% to \u20ac(0.60) in 2022 from \u20ac(0.63) in 2021. Excluding both share-based compensation (IFRS2) and financial Kreos-related (IFRS9) non-cash expenses, the adjusted net loss amounted to \u20ac32.7 million in 2022 compared to \u20ac24.0 in 2021.\n\n \n\nNet cash flows from operating activities<\/strong> amounted to \u20ac(33.8) million in 2022 compared to \u20ac(17.1) million a year earlier, primarily as a result of a single quarter of revenues generated by LUMEVOQ\u00ae<\/sup> in France through ATUs in 2022, as well as building the commercial infrastructure and preparing for the launch of LUMEVOQ\u00ae<\/sup> in Europe in H1 2024.\n\n \n\nThe change was also derived from a significant increase in working capital, amounting to \u20ac4.8 million in 2022 compared to \u20ac(3.9) million in 2021. This significant change was due to increased prepaid expenses, mainly in manufacturing activities, and no trade receivables at closing in 2022.\n\n \n\nNet cash flows from investment activities<\/strong> amounted to \u20ac0.2 million in 2022 compared to \u20ac(16) thousand in 2021, mainly driven by the activity of the Company\u2019s liquidity contract.\n\n \n\nNet cash flows from financing activities<\/strong> amounted to \u20ac0.1 million in 2022, reflecting the net proceeds from the convertible note with Heights Capital in December for \u20ac10.8 million offset by the amortized repayment of the state-guaranteed loan (Pr\u00eat Garanti par l\u2019\u00c9tat<\/em> or PGE) for \u20ac3.6 million and the full repayment of the bond financing from Kreos for \u20ac4.2 million, as well as the payment of interest on these debts and related to IFRS16 standard application for \u20ac1.9 million, and the repayment of obligation under finance leases for \u20ac0.9 million.\n\n \n\nIn 2021, these financing activities amounted to \u20ac23.7 million in 2021, reflecting the net proceeds from the private placement in March for \u20ac28.1 million partially offset by the amortized repayment of the state-guaranteed loan (Pr\u00eat Garanti par l\u2019\u00c9tat<\/em> or PGE) and the bond financing from Kreos.\n\n \n\nCash and cash equivalents<\/strong> totaled \u20ac10.6 million as of December 31, 2022, compared to \u20ac44.3 million as of December 31, 2021. The amounts of expected future cash flows related to the reimbursement of our financial debts were \u20ac3.4 million at less than one year and \u20ac14.5 million at more than one year.\n\n \n\nThe Company has taken measures aimed at reducing its operating cash burn in 2023, thereby extending its current cash runway through June 2023, while actively discussing options with certain existing shareholders and financial partners with a view to bridge beyond the results of the validation campaign expected in Q3 2023, which in turn would trigger the \u20ac12 million Tranche B of the EIB loan and extend the Company\u2019s cash runway to the end of 2023.\n\n \n\n \n\nGenSight Biologics will report its cash position as of March 31, 2023 on April 20, 2023.\n\n[1]<\/a> \u20ac3.1 million initially reported in the Q4 2022 Press Release on January 26, 2023. The initial amount reported did not include the non-cash accretion of the variable consideration under IFRS15. This has no impact on the number of vials sold nor on cash received from the sales.\n","protected":false},"excerpt":{"rendered":"
    \n
  • Efforts de r\u00e9duction des d\u00e9penses op\u00e9rationnelles en 2023, tout en s\u00e9curisant la production de LUMEVOQ\u00ae<\/sup> et pr\u00e9parant le lancement commercial en Europe au S1 2024<\/li>\n
  • D\u00e9marrage de la campagne PPQ d\u00e9but mai 2023, r\u00e9sultats attendus au T3 2023<\/li>\n
  • Horizon de financement confirm\u00e9 \u00e0 juin 2023<\/li>\n
  • Discussions avanc\u00e9es en cours autour d\u2019un financement \u00ab\u00a0relais\u00a0\u00bb avec certains actionnaires, avec un objectif de r\u00e9alisation dans les prochaines semaines<\/li>\n<\/ul>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[54],"tags":[],"featured-area":[],"news-topic":[79],"news-type":[76,80],"post-year":[],"class_list":["post-4100","post","type-post","status-publish","format-standard","hentry","category-communiques-de-presse-financiers","news-topic-company-and-personnel","news-type-corporate","news-type-finance"],"acf":[],"yoast_head":"\nGenSight Biologics publie ses r\u00e9sultats financiers consolid\u00e9s pour l\u2019exercice 2022 - GenSight Biologics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.gensight-biologics.com\/fr\/2023\/03\/24\/gensight-biologics-publie-ses-resultats-financiers-consolides-pour-lexercice-2022\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GenSight Biologics publie ses r\u00e9sultats financiers consolid\u00e9s pour l\u2019exercice 2022 - 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