PARIS–(BUSINESS THREAD)–Regulatory news:
GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME Eligible), a biopharmaceutical company focused on the development and commercialization of innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced its interim financial results for the first half of 2022. The full interim financial report is available on the Company’s website under the Investors section. The 2022 half-yearly annual accounts were subjected to a limited review by the Company’s auditors and approved by the Board of Directors on July 27, 2022.
“We continue to focus our efforts and resources in 2022 on addressing our manufacturing challenges as we prepare for the successful commercial launch of LUMEVOQ in 2023,” commented Thomas Gidoin, CFO of GenSight Biologics. “With a current cash track through early Q1 2023, we have been evaluating various financing options, undiluted or as undiluted as possible, over the past few months and are now closing in on discussions to close a transaction in favorable conditions in the fall.”
2022 half-yearly financial results (IFRS)
The company’s operating income decreased by 38.2% to 4.3 million euros from 6.9 million euros in the period. This decrease was essentially driven by a single quarter of the revenue generated by LUMEVOQ® in France through the temporary patient use authorization (“ATU nominative”) granted by the French National Agency for the Safety of Medicines (Agence Nationale de Sécurité du Médicament or ANSM) in 2022, following the company’s partner manufacturing problems that led to the depletion of available vials in March 2022. This revenue amounted to 3.1 million euros in the first half of 2022, compared to 5.6 million euros the previous year. The company expects to resume ATUs in early 2023 as soon as the product becomes available again. The company also generated tax credit for research (Crédit d’Impôt Recherche or CIR), amounting to 1.2 million euros in the first half of 2022 compared to 1.3 million euros in the first half of 2021.
Research and development expenses increased by 23.3% to 9.9 million euros in the first half of 2022, compared to 8.0 million euros in the previous year. Phase III clinical trials of LUMEVOQ® – RESCUE, REVERSE and REFLECT – have now been completed and patients entered long-term follow-up. More importantly, the company maintains its efforts in Chemistry, Manufacturing and Controls (CMC) activities to ensure manufacturing readiness to market under Good Manufacturing Practices (GMP) and, in particular, batch production of validation A strong focus is placed on this topic needed to complete the Marketing Authorization Application (MAA) in Europe.
Sales, medical and marketing expenses increased significantly by 76.7% to €4.0 million in the first half of 2022, from €2.3 million in the same period in 2021, reflecting the ramping up of key strategic marketing and market access activities in preparation for the planned commercial launch. of LUMEVOQ® in Europe by the end of 2023. The company is also consolidating its local presence in the main European countries, France, Germany, United Kingdom, Italy and Spain through the creation of commercial subsidiaries.
General and administrative expenses have been significantly reduced by 28.6%, to 2.3 million euros in the first half of 2022, compared to 3.3 million euros in the same period of 2021. This decrease be motivated mainly by the lower staff costs, as a result of the cancellations of the remaining 50%. of the 2020 performance share plans and 50% of the 2021 performance share plan following manufacturing issues at the company’s US partner.
The company’s operating loss increased by 79.1% in the first half of 2022 and amounted to (12.0) million euros compared to (6.7) million euros in the same period of 2021 , both driven by the reduction in revenue generated by LUMEVOQ® ATUs in France. , as well as increased CMC expenses and increased sales, medical and marketing expenses during the period to support marketing authorization and subsequent commercial launch in Europe. Cash control remains an important priority for the Group.
Finance income for the first half of 2022 amounted to €1.3 million compared to €(1.6) million for the same period in 2021. The variation is mainly due to a calculated non-cash income related to financing of bonds with Kreos, affected by the decrease in the share price during the period.
The Company’s net loss during the first half of 2022 amounted to (10.7) million euros compared to (8.3) million euros in the first half of 2021. The loss per share (depending on the weighted average of outstanding shares during the period) amounted to €(0.23) and €(0.19) for the first half of 2022 and 2021, respectively.
Net cash flows from operating activities for the first half of 2022 and 2021 were (16.7) million euros and (10.2) million euros, respectively. The change in 2022 is primarily due to increased operating expenses to support the marketing authorization and subsequent commercial launch of LUMEVOQ® in Europe, as well as the negative impact of non-effective IFRS items related to share-based payments and the change in fair value of the derivative financial instruments in the Kreos Bond deal driven by the decrease in the share price during the period.
Net cash flows from investing activities amounted to €0.1 million in the first half of 2022 compared to €0.2 million in 2021, driven primarily by liquidity contract activity from the company
Net cash flows from financing activities amounted to €(3.3) million in the first half of 2022, reflecting the repayment of our bond agreement with Kreos and our state-guaranteed loan during the period. Net cash flows from financing activities in the first half of 2021 amounted to €26.4 million and reflect the €28.1 million net proceeds from the private placement in March 2021
Cash and cash equivalents at 30 June 2022 amounted to 24.1 million euros.
GenSight Biologics will report on October 27, 2022 its cash position as of September 30, 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 core technology platforms, mitochondrial targeting sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogen nolparvovec), has been submitted for marketing approval in Europe for the treatment of Leber’s hereditary optic neuropathy (LHON), a rare mitochondrial disease affecting mainly teenagers and young adults leading to irreversible disease. blindness Through its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye via intravitreal injection to provide patients with sustainable functional visual recovery.
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