Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Encouraging initial top-line results from the first seven cohorts of the Phase I clinical study of PRX-115 for uncontrolled gout.
- PRX-115 demonstrated dose-dependent exposure and rapid reduction of plasma uric acid concentrations.
- PRX-115 was generally well tolerated, leading to the expansion of the Phase I study with an eighth cohort.
- Strong cash position enabling repayment of convertible notes due in September and ongoing operations, including the Phase II study in gout.
- Positive collaboration with commercial partner Chiesi Global Rare Diseases, which is committed to the successful commercialization of Elfabrio.
Negative Points
- Decrease in revenues from selling goods by 12% compared to the same period last year, primarily due to a decrease in sales to Chiesi.
- Significant decrease in revenues from license and R&D services by 99%, mainly due to the absence of a $20 million regulatory milestone payment from Chiesi.
- Increase in cost of goods sold by 56%, primarily due to increased sales to Pfizer and Brazil.
- Net loss of $2.2 million for the quarter, compared to a net income of $19.3 million in the same period last year.
- Uncertainty in providing sales guidance for Chiesi due to the variability in shipment timing and inventory buildup.
Q & A Highlights
Q: How has uptake been for Elfabrio by payers? Can you give us a sense of how negotiations have been going to get it on formularies?
A: Chiesi is doing well in penetrating the market both in the US and Europe. They have been successful in their efforts, and we are pleased with their progress. They are committed to continuing this trajectory.
Q: Can you provide guidance on the sales numbers to Chiesi?
A: Currently, we cannot provide specific guidance due to the variability in shipment schedules. We are still in the early stages of market penetration, and it will take some time before we can offer consistent forecasts. However, we are pleased with Chiesi's efforts and expect continued growth.
Q: Are there any milestones expected in the next year related to sales?
A: It depends on the pace of sales. We cannot provide a specific timeline at this moment, but we are optimistic about the future based on current trends.
Q: Are there any conferences targeted for reporting PRX-115 Phase I data this fall?
A: We recently participated in a conference in early June. The full set of data from all eight cohorts will be released around early November. We plan to attend the ACR conference in the fall.
Q: Where does Protalix envision positioning PRX-115 with respect to KRYSTEXXA and SEL-212 from Sobi?
A: We aim to offer an alternative to both enzymes. If Phase II results mimic Phase I, PRX-115 could be a very interesting option. Our goal is to provide a more effective treatment than current options.
Q: Can you elucidate on some of your early-stage R&D efforts and which programs you find promising?
A: We are evaluating more than half a dozen early-stage programs. Once we have validated pre-clinical data, we will share more information. We are diligently looking at opportunities and hope to update in the next quarter or two.
Q: Does the company plan to repay the convertible notes due next month or replace them with new notes?
A: We plan to repay the notes by September 1 and do not intend to refinance or take on new debt. We have sufficient resources to maintain ongoing operations, including the Phase II study for gout.
Q: Do you have ongoing meetings with Chiesi to update on sales progress?
A: Yes, we have regular meetings with Chiesi across multiple disciplines, including medical and operations. The relationship is very good, and they provide updates as needed.
Q: Are there any plans to monetize or partner the oral anti-TNF candidate?
A: The oral anti-TNF program has been suspended. We are focusing on other early-stage programs and will share updates once we have validated data.
Q: What is your position related to debt or future capital structure?
A: We have moved to a more stabilized financial position and have not raised funds in the last five or six quarters. We will continue to manage our finances cautiously.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
