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01/11 03:08
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call summary presents a mixed picture: strong revenue growth and improved net loss are positive, but rising costs, regulatory uncertainties, and lack of shareholder return plan weigh negatively. The Q&A session reveals management's evasive responses on key issues, adding uncertainty. While revenue from key partnerships is promising, the absence of clear guidance and potential supply chain challenges temper optimism. The stock price is likely to remain stable, as positive and negative factors balance out, resulting in a neutral sentiment.
Revenues from selling goods $10 million (an increase of $6.3 million or 170% compared to $3.7 million in Q1 2024). The increase resulted primarily from an increase of $5.9 million in sales to Pfizer and an increase of $0.4 million in sales to Fiocruz in Brazil.
Cost of goods sold $8.2 million (an increase of $5.6 million or 215% compared to $2.6 million in Q1 2024). The increase in cost of goods sold was primarily the result of the increase in sales to Pfizer and Fiocruz in Brazil.
Research and development expenses $3.5 million (an increase of $0.6 million or 21% compared to $2.9 million in Q1 2024). The increase in research and development expenses resulted primarily from the advance in our clinical pipeline.
Selling, general and administrative expenses $2.6 million (a decrease of $0.5 million or 16% compared to $3.1 million in Q1 2024). The decrease resulted primarily from a decrease of $0.4 million in salary-related expenses and a decrease of $0.1 million in selling expenses.
Financial income net $0.4 million (compared to $0.1 million in Q1 2024). The difference resulted primarily from lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal interest payable under our then outstanding 7.5% Senior Secured Promissory Notes, partially offset by lower interest income on bank deposits and higher exchange rate costs.
Net loss $3.6 million or $0.05 per share (compared to $4.6 million or $0.06 per share in Q1 2024).
PRX-115 Phase 2 Clinical Trial: Protalix is focused on initiating a Phase 2 clinical trial for PRX-115 in patients with gout later this year, following promising results from a first-in-human study.
Elfabrio Dosing Frequency Submission: Chiesi Global Rare Disease submitted a variation to the EMA to reduce the dosing frequency of Elfabrio from 1 mg/kg every two weeks to 2 mg/kg every four weeks.
PRX-119 Development: PRX-119, a PEGylated recombinant human DNase I candidate, is in preclinical development for diseases associated with neutrophil extracellular traps.
Revenue Growth: Protalix reported revenues of $10 million for Q1 2025, a 170% increase from $3.7 million in Q1 2024, primarily due to increased sales to Pfizer and Fiocruz.
R&D Expenses: Total R&D expenses for Q1 2025 were approximately $3.5 million, a 21% increase from $2.9 million in Q1 2024, reflecting advancements in the clinical pipeline.
SG&A Expenses: Selling, general and administrative expenses decreased by 16% to $2.6 million in Q1 2025, down from $3.1 million in Q1 2024.
Focus on Early-Stage Development: Protalix is concentrating R&D efforts on early-stage development assets, leveraging its ProCellEx platform and PEGylation capabilities.
Regulatory Issues: The company is awaiting feedback from the European Medicine Agency (EMA) regarding a submission to reduce the dosing frequency for Elfabrio, which could impact future sales and regulatory compliance.
Supply Chain Challenges: The increase in cost of goods sold by 215% indicates potential supply chain challenges, particularly related to increased sales to Pfizer and Fiocruz in Brazil.
Research and Development Expenses: R&D expenses increased by 21%, which may indicate financial strain as the company invests heavily in clinical trials and pipeline development.
Economic Factors: The company faces economic pressures reflected in the net loss of approximately $3.6 million for Q1 2025, which could affect future funding and operational capabilities.
Competitive Pressures: The company is focused on building its product pipeline to remain competitive in the biopharmaceutical market, particularly with the development of PRX-115 and PRX-119.
PRX-115 Phase 2 Clinical Trial: Protalix is focused on initiating a Phase 2 clinical trial for PRX-115 in patients with gout later this year, building on the momentum from promising results in 2024.
Pipeline Development: The company is evaluating additional pipeline candidates, including PRX-119 and other early-stage clinical assets, to enhance its product development pipeline.
Partnership with Chiesi: Protalix's commercial partner, Chiesi Global Rare Disease, is investing in Elfabrio and has submitted a variation to the EMA to reduce dosing frequency, which is expected to be reviewed in Q4 2025.
R&D Focus: The company is concentrating R&D efforts on early-stage development assets, leveraging its ProCellEx platform and focusing on renal rare diseases.
Revenue Expectations: Protalix recorded revenues of $10 million for Q1 2025, a 170% increase from $3.7 million in Q1 2024, primarily due to increased sales to Pfizer and Fiocruz.
Future Financial Projections: The company expects minimal revenues from license and R&D services going forward, primarily from potential regulatory milestone payments.
Cash Position: As of March 31, 2025, Protalix had approximately $34.7 million in cash, cash equivalents, and short-term bank deposits.
Net Loss: The net loss for Q1 2025 was approximately $3.6 million, an improvement from a net loss of $4.6 million in Q1 2024.
Shareholder Return Plan: None
The earnings call reveals mixed signals: increased R&D expenses and net loss improvement are positive, but unclear responses on revenue guidance and cash burn are concerning. The positive outlook for PRX-115's market potential and Elfabrio's potential EMA approval are offset by limited visibility on financial metrics. The Q&A section highlights uncertainties, with management's evasive answers potentially dampening investor confidence. Overall, the stock is likely to remain stable, resulting in a neutral sentiment.
The earnings call presents a mixed picture: increased revenues and a return to profitability are positive, but higher R&D expenses and unclear management responses in the Q&A raise concerns. While strong sales to Chiesi and improved net income are encouraging, the lack of guidance on key strategic areas and potential financial strain from increased R&D costs suggest a cautious outlook. The absence of a new partnership announcement or significant guidance changes also tempers enthusiasm, leading to a neutral sentiment prediction.
The earnings call reveals several concerns: missed EPS expectations, increased R&D expenses, and significant supply chain costs. While revenue from selling goods increased, the cost of goods sold rose dramatically, indicating potential operational inefficiencies. The Q&A session highlighted uncertainties in regulatory outcomes and vague management responses, further undermining confidence. Despite some positive revenue growth, the lack of a share repurchase program and financial instability suggest a negative outlook for the stock price.
The earnings call summary presents a mixed picture: strong revenue growth and improved net loss are positive, but rising costs, regulatory uncertainties, and lack of shareholder return plan weigh negatively. The Q&A session reveals management's evasive responses on key issues, adding uncertainty. While revenue from key partnerships is promising, the absence of clear guidance and potential supply chain challenges temper optimism. The stock price is likely to remain stable, as positive and negative factors balance out, resulting in a neutral sentiment.
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