Protalix BioTherapeutics (PLX) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Mike Moyer - Managing DirectorDror Bashan - President, CEO & DirectorEyal Rubin - SVP and CFODaniel Smith - Equity Research Associate Conference Call Participants John Vandermosten - Senior AnalystDan Akschuti - Equity Partner - Biotech AnalystNone - Analyst Operator Good morning, ladies and gentlemen, and welcome to the Protalix Biotherapeutics First Quarter twenty twenty five Financial and Business Results C ...

Financial Data and Key Metrics Changes - The company recorded revenues from selling goods of $10 million for Q1 2025, an increase of $6.3 million or 170% compared to $3.7 million in Q1 2024, primarily due to increased sales to Pfizer and Fearcruz in Brazil [11][12] - Cost of goods sold was $8.2 million for Q1 2025, an increase of $5.6 million or 215% from $2.6 million in Q1 2024 [12] - Net loss for Q1 2025 was approximately $3.6 million or $0.05 per share, compared to a net loss of $4.6 million or $0.06 per share in the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenues from license and R&D services were $100,000 for both Q1 2025 and Q1 2024, indicating minimal change [11][12] - Total research and development expenses increased to approximately $3.5 million in Q1 2025, up $600,000 or 21% from $2.9 million in Q1 2024, primarily due to advancements in the clinical pipeline [12][13] - Selling, general, and administrative expenses decreased to $2.6 million in Q1 2025, down $500,000 or 16% from $3.1 million in Q1 2024 [13] Market Data and Key Metrics Changes - The company is focused on the European market with a submission to the EMA to reduce dosing frequency for PEGUNIGARCID, expecting feedback in Q4 2025 [7][8] - The company plans to initiate a Phase II clinical trial for PRX-115 in patients with gout later in 2025, with a focus on the U.S. market for patient enrollment [6][10] Company Strategy and Development Direction - The company aims to build on the momentum from its Phase I study of PRX-115 and is evaluating additional pipeline candidates for further development [4][10] - The strategy includes leveraging the Procedex platform and focusing on early-stage development assets in renal rare diseases [9][10] - The management expressed confidence in the company's strategy and balance sheet to support future pipeline development [17] Management's Comments on Operating Environment and Future Outlook - Management highlighted strong sales efforts and recruitment of commercial patients, exceeding expectations [21][22] - The company is optimistic about the potential approval of dosing frequency changes in the U.S. and Europe, with no current red flags in the application process [23][24] - The management is excited about the progress in R&D efforts and the foundation being laid for future developments [17] Other Important Information - Cash, cash equivalents, and short-term bank deposits were approximately $34.7 million as of March 31, 2025 [15] - The company expects minimal revenues from license and R&D services going forward, primarily from potential regulatory milestone payments [12][51] Q&A Session Summary Question: Visibility on El Fabrio milestone - Management indicated strong sales efforts and recruitment of commercial patients, with improvements noted every quarter [21][22] Question: Dosing frequency application in the U.S. - Management confirmed that the application is ongoing and they are encouraged by the process [23][24] Question: Comparison with other gout medications - Management expressed optimism about the Phase II trial outcomes and potential competitive advantages, but refrained from discussing specific competitors [27][30] Question: Options close to expiration - Most warrants from the 2020 PIPE transaction expired, with minimal amounts exercised [32] Question: Phase II trial enrollment in the U.S. - Majority of patients will be enrolled in the U.S., with hopes for a good safety and immunogenicity profile [38] Question: Effects of U.S. pharmaceutical tariffs - Management clarified that their relationship with Chiesi is not expected to be impacted by the tariffs [44] Question: Remaining value of the contract with Kiese - Management explained that future revenues from Kiese will primarily be regulatory milestones, with potential milestones estimated up to $75 million [52][53]