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01/11 03:07
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
Revenues from selling goods $10 million (increase of $6.3 million or 70% compared to $3.7 million in Q1 2024). The increase resulted primarily from an increase of $5.9 million to Pfizer and an increase of $400,000 in sales to Fircruz in Brazil.
Revenues from license and R&D services $100,000 (no change compared to Q1 2024). Revenues are primarily from license supply agreements with Chiesi.
Cost of goods sold $8.2 million (increase of $5.6 million or 215% compared to $2.6 million in Q1 2024). The increase was primarily due to the increase in sales to Pfizer and Fircruz in Brazil.
Research and development expenses $3.5 million (increase of $600,000 or 21% compared to $2.9 million in Q1 2024). The increase resulted primarily from the advancement in the clinical pipeline.
Selling, general, and administrative expenses $2 million (decrease of $500,000 or 16% compared to $3.1 million in Q1 2024). The decrease was primarily due to a decrease of $400,000 in salary-related expenses and a decrease of $100,000 in selling expenses.
Financial income net $400,000 (increase from $100,000 in Q1 2024). The difference resulted primarily from lower notes interest expenses due to the repayment of 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 a net loss of $4.6 million or $0.06 per share in Q1 2024).
PRX-115 Clinical Development: Protalix is focused on initiating a phase two clinical trial for PRX-115 in patients with gout later this year, following promising results from the first in human study.
PRX-119 Development: The clinical development of PRX-119, a pegylated recombinant human DNLAS one candidate, is ongoing, focusing on diseases associated with neutrophil extracellular traps.
Revenue Growth: Protalix reported revenues from selling goods of $10 million for Q1 2025, a 70% increase compared to $3.7 million in Q1 2024, primarily due to increased sales to Pfizer and Fircruz.
Chiesi Partnership: Chiesi Global Rare Diseases is increasing its focus on Ophabolio, with a submission to the EMA to reduce dosing frequency, which may enhance market positioning.
R&D Expenses: Total R&D expenses increased by 21% to approximately $3.5 million in Q1 2025, reflecting advancements in the clinical pipeline.
Cost of Goods Sold: Cost of goods sold rose to $8.2 million in Q1 2025, a 215% increase from $2.6 million in Q1 2024, driven by higher sales.
Focus on Early-Stage Development: Protalix is concentrating on early-stage development assets to build its product pipeline, leveraging its prosthetics platform and pegylation capabilities.
Earnings Expectations: Protalix BioTherapeutics missed earnings expectations, reporting an EPS of $-0.05 against an expectation of $0.08, indicating potential financial instability.
Regulatory Risks: The company is awaiting a decision from the European Medicine Agency (EMA) regarding a submission to reduce dosing frequency for its product, which could impact market access and revenue.
R&D Expenses: Research and development expenses increased by 21% to approximately $3.5 million, indicating higher investment in clinical trials, which may pose financial risks if outcomes are unfavorable.
Supply Chain Challenges: The increase in cost of goods sold by 215% to $8.2 million suggests potential supply chain challenges, particularly with increased sales to partners like Pfizer and Fircruz.
Market Competition: The company is focusing on early-stage development assets, which may expose it to competitive pressures in the biotech industry, particularly in rare diseases.
Economic Factors: The financial income net decreased due to lower interest income and higher exchange rate costs, indicating vulnerability to economic fluctuations.
PRX-115 Phase Two Clinical Trial: Protalix is focused on initiating the phase two clinical trial in patients with gout later this year, building on the momentum from the promising results of the first in human study.
Pipeline Development: The company is evaluating additional pipeline candidates for potential further development, including PRX-119 and other early-stage clinical assets.
Collaboration with Chiesi: Protalix's commercial partner, Chiesi Global Rare Diseases, is investing in medical and commercial programs for Ophabolio, with a submission to the EMA to reduce dosing frequency.
R&D Focus: The company is focusing on early-stage development assets and leveraging its platform for potential treatments in renal rare diseases.
Revenue Expectations: Protalix recorded revenues from selling goods of $10 million for Q1 2025, a 70% increase compared to $3.7 million in Q1 2024.
Cost of Goods Sold: Cost of goods sold increased to $8.2 million in Q1 2025, up 215% from $2.6 million in Q1 2024.
R&D Expenses: Total R&D expenses were approximately $3.5 million for Q1 2025, a 21% increase from $2.9 million in Q1 2024.
Net Loss: 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 Q1 2024.
Cash Position: Cash, cash equivalents, and short-term bank deposits were approximately $34.7 billion at March 31, 2025.
Share Repurchase Program: 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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