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Dec 31, 2021
Protalix Q4 2021 Earnings Report
Protalix reported financial results for fiscal year 2021 and provided a business update.
Key Takeaways
Protalix BioTherapeutics reported its financial results for the fiscal year ended December 31, 2021. The company's revenue from selling goods increased slightly, while revenue from licenses and R&D services decreased. Operating loss and net loss were reported for the year.
Submitted MAA to the EMA, which was subsequently validated by the EMA.
Completed a Type A meeting with the FDA regarding the biologics license application (BLA) for PRX-102.
Announced positive final results from the phase III BRIGHT clinical trial.
Strengthened its balance sheet through exchanges of a substantial majority of its then outstanding 7.50% Senior Secured Convertible Notes due 2021.
Protalix
Protalix
Forward Guidance
Protalix plans to resubmit its BLA in the United States and awaits feedback on its MAA submission in Europe, while continuing to advance its early-stage pipeline.
Positive Outlook
- BLA resubmission planned for the second half of 2022.
- FDA agreed that the data package proposed to the FDA for the anticipated BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease.
- MAA to the EMA was validated.
- Phase III BRIGHT clinical trial results were positive.
- The company anticipates announcing top-line results from the BALANCE study
Challenges Ahead
- Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial.
- The company's dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services
- The impact of development of competing therapies and/or technologies by other companies and institutions
- Potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage
- The company may face delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process