Release Date: May 10, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Protalix BioTherapeutics Inc (PLX, Financial) reported encouraging initial top-line results from the first seven cohorts of the Phase 1 study of PRX-115, leading to the extension of the study with an additional cohort.
- The company has initiated preparations for a Phase 2 clinical trial of PRX-115, demonstrating progress in its development pipeline.
- ELFABRIO, Protalix BioTherapeutics Inc (PLX)'s second approved drug, continues to gain regulatory approvals globally, expanding its market presence.
- Protalix BioTherapeutics Inc (PLX) maintains a strong cash position, providing financial stability and sufficient funds to repay convertible notes due in September 2024 and support ongoing operations.
- Sales to Chiesi are expected to gradually increase as future approvals and launches in additional countries are anticipated, potentially strengthening revenue streams.
Negative Points
- Protalix BioTherapeutics Inc (PLX) experienced a decrease in revenue from selling goods by 27% in Q1 2024 compared to Q1 2023, primarily due to reduced sales to Pfizer and Brazil.
- Revenue from license and R&D services decreased by 98% in Q1 2024 compared to the same period last year, following the completion of research and development obligations related to ELFABRIO.
- A subject in the PRX-115 study experienced an anaphylactic reaction, although it was resolved, indicating potential safety concerns that need to be addressed in future studies.
- The company recorded a net loss of approximately $4.6 million in Q1 2024, indicating ongoing financial challenges despite a strong cash position.
- There is uncertainty regarding the competitive landscape for PRX-115, particularly in comparison to existing treatments like Krystexxa, and the potential need for differentiation in efficacy, safety, and convenience.
Q & A Highlights
Q: Can you delineate the specific gout subpopulation in which PRX-115 might be utilized if approved, and what the competitive landscape looks like?
A: Dror Bashan, President and CEO, explained that PRX-115 is intended for uncontrolled gout patients. The company is optimistic about moving to a Phase II study, aiming for improved safety and dosing frequency. PRX-115 aims to compete with existing treatments like Krystexxa by potentially offering better safety and efficacy.
Q: What efficacy endpoints are expected in Phase II for PRX-115, and will it compete directly with Krystexxa?
A: Dror Bashan noted that the design of the Phase II study and its endpoints will be clearer after regulatory discussions. The intent is to position PRX-115 as a direct competitor in the market for uncontrolled gout patients.
Q: How do the pharmacokinetic (PK) levels of PRX-115 trend over the observed three-month period post-infusion?
A: Dror Bashan mentioned that full PK, pharmacodynamics (PD), and safety data from all cohorts will be shared once available, emphasizing the importance of comprehensive data before making further decisions.
Q: What are the plans for the geographical expansion of clinical trial sites for PRX-115 in Phase II?
A: Dror Bashan indicated that while sites have not been finalized, the company plans to include locations in the US and other continents, moving beyond the current sites in Australia.
Q: How is the R&D budget allocated among PRX-115, PRX-119, and other early-stage assets?
A: Dror Bashan clarified that PRX-115 will be the main consumer of R&D resources, with careful management of spending to maintain financial stability. The company aims to invest in early research candidates addressing unmet needs in gout disease without exceeding their current capabilities.
Q: Can you provide insights into the increase in contracts liability and its impact on cash flow?
A: Eyal Rubin, CFO, explained that the increase in contractual obligations is due to batches paid for by Chiesi but not yet recorded as revenue, affecting cash flow positively. This reflects ongoing sales and the expected gradual increase in market share by Chiesi.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
