Protalix BioTherapeutics(PLX) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company experienced a 50% increase in revenues from selling goods compared to the same period last year [3] - Revenues from selling goods were $15.4 million for Q2 2025, an increase of $2.1 million or 16% compared to $13.3 million for Q2 2024 [12] - Net income for Q2 2025 was approximately $164,000 or $0 per share, compared to a net loss of approximately $2.2 million or $0.03 per share for the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by sales of Elfabrio to Chiesi, with an increase of $8 million in sales to Chiesi, partially offset by a decrease of $4.7 million in sales to Brazil and $1.2 million in sales to Pfizer [12] - Research and development expenses increased by $3 million or 100% to approximately $6 million in Q2 2025, primarily due to preparations for the planned Phase II clinical trial of PRX-115 [14] Market Data and Key Metrics Changes - The global market for Fabry disease is approximately $2.3 billion in 2025 and is forecasted to reach approximately $3.2 billion by 2030 [4] - The company anticipates El Fabryo royalties exceeding $100 million by 2030 based on a projected 15% to 20% market share of the estimated $3.2 billion Fabry total market [6] Company Strategy and Development Direction - The company is focused on building its product development pipeline, particularly in early-stage development assets and therapeutic areas related to renal rare diseases [8] - The company plans to initiate a Phase II study for PRX-115 in 2025 and enroll the first patient in Q4 2025 [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic plan and the foundation being built for future growth, emphasizing the excitement around the Phase II program for PRX-115 [18] - The management noted that Chiesi has been performing better than expected in the marketplace, with significant growth in patient acquisition [28] Other Important Information - The company had $33.4 million in cash and cash equivalents and short-term bank deposits as of June 30, 2025 [16] - Eyal Rubens, the Chief Financial Officer, is stepping down after six years, and Gilad Mambloc will succeed him [9][10] Q&A Session Summary Question: Comments on Chiesi's planned study called Pagasso - Management confirmed it is part of Chiesi's phase four program to enhance the merits and strengths of the program [22][23] Question: Details on the Phase II trial for PRX-115 - The company plans to operate between 20 to 30 sites for the trial, primarily in the U.S. [24][25] Question: Market share held by Chiesi in Fabry disease - Management stated they do not disclose specific market share numbers but assured that Chiesi is performing well and growing its market share [27][28] Question: Utilization of Gilad's experience in business development - Management clarified that while Gilad has significant experience, the company is currently not planning any mergers or acquisitions and is focusing on growing its pipeline [30][32]