Protalix BioTherapeutics(US:PLX)2023-11-06 16:57Financial Data and Key Metrics Changes - Cost of goods sold decreased by $2.2 million, or 31%, to $4.9 million for Q3 2023 compared to $7.1 million for Q3 2022, primarily due to decreased sales to Pfizer, partially offset by increased sales of Elfabrio to Chiesi and Elelyso to Brazil [8] - Net loss for Q3 2023 was approximately $1.9 million, or $0.03 per share, compared to a net loss of $3.6 million, or $0.07 per share, for the same period in 2022 [10] - Revenues from selling goods increased by $1.4 million, or 16%, to $10.2 million in Q3 2023 compared to $8.8 million in Q3 2022, driven by increased sales to Chiesi and Brazil, offset by decreased sales to Pfizer [31] - Total research and development expenses decreased by $3.7 million, or 50%, to approximately $3.7 million in Q3 2023 compared to $7.4 million in Q3 2022, primarily due to the completion of the Fabry clinical program [32] Business Line Data and Key Metrics Changes - Revenues from license and R&D services decreased by $5.2 million, or 96%, to $0.2 million in Q3 2023 compared to $5.4 million in Q3 2022, due to the transfer of sponsorship of extension studies to Chiesi [18] - Selling, general and administrative expenses increased by $0.9 million, or 32%, to $3.7 million in Q3 2023 compared to $2.8 million in Q3 2022, primarily due to increased salary and related expenses [19] Market Data and Key Metrics Changes - The company has received regulatory approvals for Elfabrio in the UK and Switzerland, with plans to expand into other markets, including Japan [38] - The company is focusing on building market presence and inventory with Chiesi, which is expected to fluctuate over the next couple of years [37] Company Strategy and Development Direction - The company is committed to developing its pipeline assets to address high unmet medical needs, following the approval of Elfabrio and Elelyso [15] - The company aims to maintain a strong balance sheet to support strategic plans without the need for near-term capital infusion [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to operate without disruptions despite challenging circumstances in Israel [14] - The company does not provide specific revenue guidance for Q4 2023 due to the dynamic nature of orders from Chiesi and Pfizer [42] Other Important Information - The company announced the appointment of Dr. Eliot Forster as Chairman of the Board, succeeding Mr. Zeev Bronfeld [30] - Cash, cash equivalents, and short-term bank deposits were approximately $41 million as of September 30, 2023 [20] Q&A Session Summary Question: What are the underlying factors for the drop in revenue from $15 million in Q2 to $10 million in Q3? - Management indicated that the decrease was due to reduced sales to Pfizer and inventory buildup by Chiesi, which may lead to fluctuations in sales as they penetrate the market [12][37] Question: Can you discuss the Fabry disease market opportunity in the UK and Switzerland? - Management noted that the drug has been approved in most Western countries, including the UK and Switzerland, and they are looking to expand into other markets like Japan [38] Question: What are the next steps for the PRX-115 program? - The company plans to gather data from the ongoing Phase 1 study and will decide on further steps based on safety and efficacy results [60] Question: How does the company view its capital structure with two revenue-generating products? - Management stated that the company is self-sustained and does not foresee the need for additional capital in the near future, expecting gradual changes in capital structure as revenues ramp up [52] Question: What are the expectations for the topline results from the PRX-115 study? - Management indicated that topline results are expected in mid-2024, and they will assess the data to determine the next steps for the program [16][54]