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01/11 03:11
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
Total revenues for the first 9 months of 2025 $43.6 million, representing a 24% increase compared to the same period last year. The increase is attributed to the continued commercial success of enzyme replacement therapies.
Total revenues for the third quarter of 2025 $17.9 million, reflecting a decrease of 1% compared to the same period of 2024. The decrease is due to variations in purchases by partners who control their own inventories.
Revenues from selling goods for the first 9 months of 2025 $43.1 million, an increase of $8.3 million or 24% compared to $34.8 million for the same period in 2024. This includes $18.6 million in sales of Elfabrio to Chiesi, $15.4 million in sales of Elelyso to Pfizer, and $9.1 million in sales of Elelyso to Fiocruz in Brazil.
Revenues from selling goods for the third quarter of 2025 $17.7 million, a decrease of $0.1 million or 1% compared to $17.8 million for the same period in 2024. This includes $8.8 million in sales of Elfabrio to Chiesi, $2.8 million in sales of Elelyso to Pfizer, and $6.1 million in sales of Elelyso to Fiocruz in Brazil.
Revenues from license and R&D services for the first 9 months of 2025 $0.5 million, an increase of $0.1 million compared to $0.4 million for the same period in 2024. This is mainly from the license and supply agreement with Chiesi.
Revenues from license and R&D services for the third quarter of 2025 $0.2 million, an increase of $0.1 million compared to $0.1 million for the same period in 2024. This is also mainly from the license and supply agreement with Chiesi.
Cost of goods sold for the first 9 months of 2025 $22.4 million, up $2 million or 10% from $20.4 million for the same period last year. The increase reflects higher sales to Chiesi and Pfizer, partially offset by a decrease in sales to Fiocruz.
Cost of goods sold for the third quarter of 2025 $8.3 million, a decrease of $0.1 million or 1% from $8.4 million for the same period in 2024. The decrease is due to lower sales to Chiesi and Pfizer, partially offset by increased sales to Fiocruz.
Research and development expenses for the first 9 months of 2025 $13.9 million, an increase of $5.1 million or 58% compared to $8.8 million for the prior year period. The increase is mainly due to preparations for the planned Phase II clinical trial of PRX-115.
Research and development expenses for the third quarter of 2025 $4.5 million, an increase of $1.5 million or 50% compared to $3 million for the same period of 2024. The increase is also due to preparations for the planned Phase II clinical trial of PRX-115.
Selling, general and administrative expenses for the first 9 months of 2025 $8.2 million, down $1 million or 11% from $9.2 million for the same period last year. The decrease is mainly due to lower salary and selling expenses.
Selling, general and administrative expenses for the third quarter of 2025 $2.9 million, an increase of $0.3 million or 12% compared to $2.6 million for the same period in 2024. The increase is due to higher salary and selling expenses.
Net loss for the first 9 months of 2025 $1.1 million or $0.01 per share basic and diluted, compared to a net loss of $3.6 million or $0.05 per share for the same period in 2024. The improvement is due to strong financial discipline and increased revenues.
Net income for the third quarter of 2025 $2.4 million or $0.03 per share basic and diluted, compared to $3.2 million or $0.04 per share basic and $0.03 per share diluted for the same period in 2024. The decrease is due to variations in financial income and expenses.
Elfabrio: Continued commercial success with enzyme replacement therapies. Efforts are ongoing to reexamine the negative opinion on the once-in-4-weeks dose regimen in Europe, while the approved every-2-weeks regimen remains unaffected.
PRX-115: Preparations for Phase II clinical trial are underway. IND filed in October 2025 and became effective after FDA review. Potential to be a best-in-class therapy for uncontrolled gout with a long-acting profile.
Revenue Growth: Total revenues for the first 9 months of 2025 were $43.6 million, a 24% increase compared to the same period in 2024. However, Q3 revenues decreased by 1% year-over-year to $17.9 million.
Financial Discipline: Maintained a strong cash position of $29.4 million as of September 30, 2025, sufficient for at least 12 months of operations. Positive quarterly net income achieved.
Cost Management: Cost of goods sold increased by 10% for the 9 months ended September 30, 2025, reflecting higher sales to Chiesi and Pfizer. R&D expenses rose by 58% due to PRX-115 trial preparations.
Pipeline Focus: Strategic focus on advancing PRX-115 and other early-stage programs, alongside maintaining financial discipline and driving commercial success with Elfabrio.
Regulatory Hurdles: The negative opinion issued by the Committee for Medicinal Products for Human Use (CHMP) regarding the proposed every 4 weeks dose regimen for Elfabrio in Europe poses a regulatory challenge. Although the currently approved every 2 weeks regimen is unaffected, the reexamination process requires additional data and collaboration with Chiesi, which could delay potential benefits to patients and caregivers.
Revenue Variability: Revenues from product sales to partners like Chiesi, Pfizer, and Fiocruz vary quarter-to-quarter as these partners control their own inventories. This variability may not align with patient demand, potentially impacting financial predictability and operational planning.
R&D Investment Risks: The significant increase in research and development expenses, particularly for the Phase II clinical trial of PRX-115, represents a financial risk. If the trial does not yield successful results, the investment may not translate into long-term growth.
Economic and Financial Risks: The company recorded a net loss of $1.1 million for the 9 months ended September 30, 2025, despite positive quarterly net income. Additionally, financial income decreased due to exchange rate costs and lower interest income, which could impact overall financial stability.
Elfabrio's long-term potential: Protalix remains confident in Elfabrio's long-term potential and is working closely with Chiesi to provide additional data to support the reexamination of the once in 4 weeks regimen in Europe. The company believes this regimen could offer meaningful benefits to patients and caregivers.
PRX-115 development: Preparations for the Phase II clinical trial of PRX-115, a recombinant PEGylated uricase candidate for uncontrolled gout, are well underway. The IND for the trial has been filed and approved, and the trial is planned to initiate later this year. Protalix believes PRX-115 has the potential to be a best-in-class therapy with a long-acting profile that could improve patient compliance and outcomes.
Market opportunity for PRX-115: If successful, PRX-115 represents a significant opportunity in a market with high unmet needs.
Operating strategy: Protalix's operating strategy focuses on driving commercial success with Elfabrio, advancing PRX-115 and other early-stage pipeline programs, and maintaining financial discipline.
The selected topic was not discussed during the call.
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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