GenSight Biologics, a biopharmaceutical company listed on Euronext under the ticker symbol SIGHT and ISIN FR0013183985, eligible for PEA-PME, has disclosed its consolidated financial performance for the full year 2023. This report, approved by the Board of Directors on March 21, 2024, follows the completion of audit procedures by the Company’s statutory auditors. Final certification is pending completion of necessary procedures before filing the Universal Registration Document with the French market authority (Autorité des Marchés Financiers).
Laurence Rodriguez, CEO of GenSight Biologics, highlighted the strategic initiatives undertaken in 2023 to streamline operational expenses and prolong cash reserves, with anticipated full impact in 2024. Rodriguez stated, “We are now dedicating all our resources to making LUMEVOQ® doses available, which should enable us to resume our compassionate access programs in France, expected in the third quarter of 2024, as well as to discussions around new financing options with our investors and strategic partners that will fund our activities until this resumption.”
Annual Consolidated Financial Statements (IFRS) for the Year Ending December 31, 2023 and December 31, 2022
| In million euros | As of December 31, | |||
| 2022 | 2023 | |||
| Cash and cash equivalent | 10.6 | 2.1 | ||
| Total assets | 25.9 | 9.1 | ||
| Total shareholders’ equity | (15.3) | (30.7) | ||
| Total liabilities | 41.2 | 39.8 | ||
| In million euros | 2022 | 2023 | ||
| Operating income | 4.9 | 3.0 | ||
| Research and development expenses | (19.3) | (19.4) | ||
| Sales and marketing expenses | (8.0) | (7.9) | ||
| General and administrative expenses | (5.4) | (5.4) | ||
| Operating profit (loss) | (27.8) | (29.7) | ||
| Financial profit (loss) | 0.2 | 3.5 | ||
| Net profit (loss) | (27.6) | (26.2) | ||
| EPS (in € per share) | (0.60) | (0.54) | ||
| Net cash flows from operating activities | (33.8) | (24.7) | ||
| Net cash flows from investing activities | 0.2 | 0.2 | ||
| Net cash flows from financing activities | 0.1 | 15.9 | ||
| Net cash flows | (33.5) | (8.6) | ||
| Cash and cash equivalents at closing | 10.6 | 2.1 |
Research Tax Credit (CIR) decreased from €2.2 million in 2022 to €1.7 million in 2023, reflecting reduced clinical development expenses for LUMEVOQ® as the company navigates regulatory pathways and designs the protocol for its new phase III clinical trial, RECOVER.
The company reported a decline in operating income from €4.9 million as of December 31, 2022, to €3.0 million as of December 31, 2023, primarily due to the absence of revenue from named Patient Temporary Use Authorizations (ATU) for LUMEVOQ® in 2023. Production issues at the company’s partner resulted in the depletion of available doses by March 2022. Plans are underway to resume product availability under the Compassionate Use Authorization (AAC) in France in Q3 2024.
Despite stable research and development expenses, other operational costs saw fluctuations. Sales and marketing expenses reached €7.9 million in 2023, down from €8.0 million in 2022, following the withdrawal of the marketing authorization application with the EMA for LUMEVOQ®.
General and administrative expenses remained stable at €5.4 million in both 2022 and 2023. However, operating loss increased to €(29.7) million in 2023 from €(27.8) million in 2022, primarily due to decreased operating income and increased “non-cash” expenses related to share-based payments.
Financial results showed a gain of €0.2 million in 2022, compared to €3.5 million in 2023, primarily attributed to fair value changes of derivative financial instruments. Net loss decreased to €(26.2) million in 2023 from €(27.6) million in 2022.
Net cash flows from operating activities improved to €(24.7) million in 2023 from €(33.8) million in 2022, despite no revenue generation in 2023. Cash and cash equivalents stood at €2.1 million as of December 31, 2023, compared to €10.6 million a year prior.
With a net funding requirement of €9 million for the next 12 months, the company seeks additional financing to extend its cash runway until the anticipated resumption of the AAC program in Q3 2024.
For further details on GenSight Biologics’ financial performance and risk factors, refer to the Company’s Universal Registration Document and related filings accessible on its website and AMF platform. GenSight Biologics will provide an update on its cash position as of March 31, 2024, on April 4, 2024.
