A biopharma company, GenSight biologics, has released its 2020 financial report and also provided an outlook into its 2021 financial goals. The bio-firm works on discovering and developing innovative gene therapies for various diseases, including central nervous system disorders or retinal neurogenerative diseases.
The 2020 Financial Result and 2021 Outlook: GenSight Biologics Report
Audit procedures are completed through the company’s statuary audit committee. The audit reports are not yet issued.
Bernard Gilly, co-founder and the chief executive officer of Gensight Biologics, commented that they had filled the market authorization application with the European Medicines Agency. Following this, GenSight is set to begin a new chapter in its growth. The company is going to be a commercial organization. By the start of the next year, 2022, European sales and marketing infrastructure will be established for the company’s commercial launch.
He added that the company will continue with filing the market authorization application and other required formalities with the Food and Drug Administration (FDA) in the United States by the end of 2021.
According to Thomas Gidoin, the chief financial officer of GenSight Biologics, they are beginning their 2021 journey on strong financial grounds. They have cut down the operating cash burn by 46%, securing around 34 million euros to begin the business in Europe. He added that with this data, they can finance the company till the first quarter of 2022. They are optimistic about doing well so that they can finance the commercial launch of LUMEVOQ through 2022. They are seeking conditions that can sustain the financial goal.
The operating income of GenSight Biologics has increased to 7.4 million euros is 2020from 4.9 million euros in 2019. This was about a 51.5% rise in a year. The revenue was mostly due to the ATU nominative granted by the France National Drug Safety Agency. They also generated research tax credit (CIR) in 2020. Moreover, the CIR was reduced because the R&D expenses reduced in 2020.
Research and development expenses were reported to reduce by 22% in 2020 as compared to the previous year. The expense reduction in the R&D department was observed as the third phase trials of both the RESCUE and REVERSE phases were over last year. The company said that they are still investing in Chemistry and manufacturing and control activities so that the marketing authorization application of the LUMEVOQ is supported at least in Europe.
The 2022 wide-scale launch of LUMEVOQ in Europe, too on a commercial scale, led to an increase of sales and marketing expenses in 2020 compared to 2019. This was expected to ramp up the market access activities and also the key strategic marketing.
The general and administrative expenses had also increased in 2020. The non-cash share-based compensation expenses drove the increase.
GenSight Biologics, however, was able to reduce its operating loss significantly. When compared to 2019, 2020 has seen about 17.7% decrease in operating loss during 2020. The key factors for this are the net decrease in the research & development expenses and the increased revenue from ATU’s in France.
The company suffered a net loss of 34 million euro in 2020 against 30 million euro in 2019.
The European Biologics filed for their LUMEVOQ in Europe in September 2020, as expected. Through this, they are now approved for treating vision loss due to Leber Hereditary Optic neurology. This condition is caused due to a mutation in the ND4 mitochondrial gene.
With the final audit reports and assessing the financial status, a path for 2022 is clear. The company is all set to go ahead with the commercial launch of its gene therapy treatment.