GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharmaceutical company dedicated to developing and commercializing gene therapies for retinal neurodegenerative diseases and central nervous system disorders, has released its interim financial results for the first half of 2024, along with recent business updates.
The half-year financial statements for 2024 underwent a limited review by the company’s statutory auditors and were approved by the Board of Directors on September 19, 2024. A certification report will be published after the necessary filing procedures are completed and will be available by the end of September on the company’s website in the Investors section.
Financial Highlights:
- Income and Revenues:
Operating income fell by 36.4% to €1.7 million, down from €2.7 million during the same period in 2023. Revenue in 2024 is tied to the change in valuation of refund liabilities and potential rebate obligations under the current regulatory framework, following the withdrawal of the EMA application in April 2023. - R&D and Operating Expenses:
Research and development expenses dropped by 47.6% to €6.3 million, down from €12.0 million in the first half of 2023, due to reduced spending on the GS030 program and a focus on the LUMEVOQ® project. Sales, medical, and marketing expenses saw a 94.6% decrease, dropping to €0.3 million, largely due to the withdrawal of the LUMEVOQ® marketing authorization application. General and administrative expenses also decreased by 13.5% to €2.6 million. - Operating Losses and Net Results:
The company reported an operating loss of €7.4 million, a significant improvement from the €17.1 million loss in the first half of 2023. Net losses narrowed to €5.8 million from €12.0 million in the previous year. The loss per share decreased to €0.07 compared to €0.26 in H1 2023. - Cash Flow and Financial Position:
Net cash outflows from operating activities totaled €7.3 million, down from €16.2 million in 2023, reflecting reduced operational expenses. The company raised €12.1 million from capital increases during the first half of 2024. Cash and cash equivalents amounted to €6.9 million as of June 30, 2024, compared to €1.0 million in June 2023.
Operational and Business Updates:
- Manufacturing and Early Access Program:
GenSight’s LUMEVOQ® drug product batch, manufactured in July 2024, has passed essential safety tests and is undergoing final quality checks. Packaging has been completed, and the pharmaceutical release is expected in mid-October 2024. Preparations for restarting the Early Access (AAC) program in France are progressing in coordination with relevant stakeholders, with the first revenues anticipated in November 2024. - Financial Planning:
The company is funded through mid-November 2024 and expects revenue from the AAC program to extend its cash runway until Q3 2025. In the event of delays in receiving AAC-related revenues, GenSight may explore interim financing solutions or refinancing options.
Leadership Update:
GenSight Biologics has appointed Jan Eryk Umiastowski as Chief Financial Officer, effective September 16, 2024. Umiastowski brings over 26 years of experience in corporate finance, fundraising, and M&A, having previously served as Chief Investment Officer at CEGEDIM.
“I am excited to join GenSight at this pivotal moment and contribute to its financial strategy as it advances its innovative gene therapies,” said Umiastowski. CEO Laurence Rodriguez welcomed his appointment, emphasizing the importance of strengthening the company’s financial leadership amid challenging times.
The company remains committed to pursuing additional financing options, partnerships, and M&A opportunities to support its clinical trial programs and broader operational objectives.
