• Revenue from Selling Goods: $17.8 million, a 75% increase from $10.2 million in Q3 2023.
• Revenue from License and R&D Services: $0.1 million, a 50% decrease from $0.2 million in Q3 2023.
• Cost of Goods Sold: $8.4 million, a 71% increase from $4.9 million in Q3 2023.
• Research and Development Expenses: $3 million, a 19% decrease from $3.7 million in Q3 2023.
• Selling, General and Administrative Expenses: $2.6 million, a 30% decrease from $3.7 million in Q3 2023.
• Net Income: $3.2 million, compared to a net loss of $1.9 million in Q3 2023.
• Cash and Cash Equivalents: $27.4 million as of September 30, 2024.
• Income Taxes: $0.6 million, compared to $0.1 million in Q3 2023.

• Warning! GuruFocus has detected 7 Warning Signs with PLX.

Release Date: November 14, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Protalix BioTherapeutics Inc (PLX) completed all eight cohorts of the first-in-human Phase I clinical trial for PRX-115, showing promising preliminary results.
• The company reported a significant increase in revenues from selling goods, up 75% compared to the same period last year, driven by increased sales to Chiesi and Pfizer.
• Protalix BioTherapeutics Inc (PLX) is now a debt-free company after repaying all outstanding principal and interest under its senior secured convertible promissory notes.
• The company is preparing for a Phase II trial of PRX-115 in patients with uncontrolled gout, with plans to initiate the study in the second half of 2025.
• Protalix BioTherapeutics Inc (PLX) has a strong balance sheet with approximately $27.4 million in cash and cash equivalents as of September 30, 2024.

Negative Points

• Revenues from license and R&D services decreased by 50% compared to the same period last year.
• The company experienced an increase in cost of goods sold by 71%, which could impact profit margins.
• There was a reported anaphylactic reaction in one subject during the PRX-115 trial, although it was managed successfully.
• Protalix BioTherapeutics Inc (PLX) faces competitive challenges in the treatment of refractory gout, requiring further studies to establish its market position.
• The company is not currently pursuing manufacturing contracts with other companies, potentially limiting revenue diversification opportunities.

Q & A Highlights

Q: Are the revenues from Chiesi all product revenues, and should they be used for calculating gross margins? A: Yes, the revenues from Chiesi are all product revenues. They are recorded in connection with the actual goods sold to Chiesi. However, simply dividing the cost of goods sold by sales to calculate gross margins may not provide an accurate number due to varying margins on different products. - Eyal Rubin, CFO

Q: What are some market factors affecting the uptake of Elfabrio in the US, and how do you view the competitive landscape for refractory gout treatment? A: Elfabrio offers a good alternative for adult Fabry patients with a strong safety and immunogenicity profile. Chiesi is conducting additional studies to support its use. For refractory gout, we are planning a Phase II study and are in discussions with regulatory agencies. If Phase II outcomes align with Phase I, PRX-115 could be a promising treatment. - Dror Bashan, CEO

Q: Are you establishing manufacturing contracts with other companies to use your proprietary platform for producing their products? A: Currently, we are not pursuing manufacturing contracts with other companies. Our focus is on developing therapies for unmet needs rather than becoming a contract manufacturing organization. We believe this approach will bring more value to shareholders. - Dror Bashan, CEO

Q: What was the plasma uric acid level range for participants in the PRX-115 study, and was there anything unique about the subject who had an anaphylactic reaction? A: I don't have the exact plasma uric acid levels on hand, but I can provide that information later. Regarding the anaphylactic reaction, it occurred in one subject shortly after infusion began, possibly due to pre-existing antibodies. The subject recovered fully. - Dror Bashan, CEO

Q: What is the anticipated duration of the upcoming PRX-115 trial, and when do you expect to report results? A: The PRX-115 trial is expected to last 12 months, with initiation planned for the second half of 2025. We anticipate reporting top-line results by the end of 2026 or early 2027. - Dror Bashan, CEO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.