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Mar 31, 2021
Protalix Q1 2021 Earnings Report
Protalix reported a net loss and a decrease in revenue for Q1 2021 due to lower sales to Brazil and decreased revenue from license and R&D services, partially offset by increased sales to Pfizer.
Key Takeaways
Protalix BioTherapeutics reported a net loss of $5.5 million for the first quarter of 2021, compared to a net income of $1.7 million for the same period in 2020. Total revenue decreased by 47.7% to $11.32 million, driven by a decrease in sales to Brazil and a decrease in license and R&D services revenue.
Received a Complete Response Letter from the FDA for PRX-102 due to travel restrictions preventing facility inspection.
Secured $10 million milestone payment from Chiesi in exchange for a future reduction in regulatory milestone payment.
Closed a public offering of common stock, raising approximately $40.2 million in gross proceeds.
Partnered with SarcoMed USA Inc. for the worldwide development and commercialization of alidornase alfa (PRX-110).
Protalix
Protalix
Forward Guidance
The company believes that it is prudent to secure short-term funds in order to continue development of PRX-102 while waiting for the FDA’s required inspection and subsequent assessment described in the CRL.
Positive Outlook
- Advancing earlier stage pipeline.
- Working closely with the FDA.
- FDA did not report any potential safety or efficacy concerns for PRX-102.
- Believe that it is prudent to secure short-term funds in order to continue development of PRX-102.
- Chiesi agreed to make a $10.0 million milestone payment to the Company before the end of the second quarter.
Challenges Ahead
- Receipt of the Complete Response Letter from the FDA was disappointing.
- An inspection of the Company’s manufacturing facility in Carmiel, Israel, including the FDA’s subsequent assessment of any related findings is required before the FDA can approve the BLA.
- Due to travel restrictions relating to the COVID-19 pandemic, the FDA was unable to conduct the required inspection during the review cycle.
- Net loss for the three months ended March 31, 2021 was approximately $5.5 million, compared to a net income of $1.7 million for the same period in 2020.
- The Company recorded revenues from selling goods of $4.5 million during the three months ended March 31, 2021, a decrease of $0.5 million, or 10%, compared to revenues of $5.0 million for the same period of 2020.