Protalix BioTherapeutics, Inc. (PLX) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
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.
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Operating Highlights
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.
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Risk or Challenges
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.
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Guidance & Outlook
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.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you provide granularity regarding the timeline for the anticipated reexamination of the CHMP opinion on the every 4-week dosing regimen of Elfabrio?
A:The reexamination request is expected to have an answer in Q1 of 2026.
Q:Do you have any additional comments on the evolving competitive landscape in treatment refractory gout and its implications for the commercial opportunity for PRX-115?
A:The gout market is expected to grow significantly in the next 5-6 years, particularly for uncontrolled gout patients requiring uricases. If Phase II of PRX-115 is successful, it could capture a significant market share.
Q:Do you anticipate further predictability of the royalty-based revenue recognition related to Elfabrio sales going forward?
A:The company has good predictability regarding revenues and plans to provide more visibility in the annual report. However, details are limited due to the agreement with Chiesi, a privately held company.
Q:Is the cash runway guidance based solely on operating expenditures or does it include royalty-based revenue on Elfabrio?
A:The cash runway guidance is based on both operating expenditures and royalty-based revenue on Elfabrio.
Q:Does the cash runway guidance include expenses associated with the Phase II trial on PRX-115?
A:Yes, the cash runway guidance includes expenses associated with the Phase II trial on PRX-115.
Q:Does it make sense to run a new trial to get the information the EMA might be looking for regarding the every 4-week dosing regimen of Elfabrio?
A:Chiesi has submitted a request for reexamination and will present arguments in the coming months. If the decision in Q1 2026 is not favorable, Chiesi will internally discuss and decide on the next steps.
Q:What is the timeline for the PRX-115 trial if it starts in the next few weeks?
A:The company plans to start screening patients in a few weeks, with top-line results expected in Q3 of 2027.
Q:What is emerging as a follow-on to PRX-115 as another candidate in the development pipeline?
A:The company hopes to update the market soon. PRX-119 is undergoing final tests, and updates on its mechanism of action and specific indication will be provided if successful.
Q:Have there been any recent additional approvals in different geographies for Chiesi?
A:There have been no significant recent approvals. Chiesi is under submission or planning to submit in various markets over the next few years.
Q:Is there any indication of what kind of numbers you could be doing with Chiesi next year?
A:The company does not provide guidance on revenue numbers. Chiesi's revenue growth is ongoing, but there is no direct link between the company's revenues and Chiesi's due to inventory buying patterns.
Q:Do you anticipate R&D growth during the Phase II of PRX-115?
A:Yes, the company has accounted for the expenses of the PRX-115 Phase II trial and has enough cash to fund it for more than 12 months.
Q:What are your thoughts on cash burn for 2026 and its split between R&D and SG&A?
A:The company cannot provide guidance on cash burn for 2026 but has stated it has enough cash for more than 12 months, including funding for the PRX-115 Phase II trial.
Q:Review of Unclear Management Responses
A:Management avoided providing direct answers or clarity on revenue guidance for Chiesi next year and cash burn for 2026, citing limitations in providing guidance or specific numbers.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Brazil purchase
Chiesi Fiocruz
Elelyso Fiocruz
Elelyso sale
Financial
Fiocruz Brazil
II trial
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Phase II
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RD service
date result
decrease period
good month
income net
income share
increase period
license RD
month income
month increase
month period
month revenue
net period
note
period decrease
period increase
period month
period revenue
reexamination
release
revenue sale
sale Chiesi
sale Elelyso
sale product
success
tax period
therapy
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PLX Transcript
Protalix BioTherapeutics, Inc. (PLX) Q1 2026 Earnings Call Transcript
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The earnings call summary indicates a significant cash inflow from a strategic partnership, which is positive. However, the lack of detailed financial performance metrics, absence of shareholder return discussion, and mention of potential regulatory risks balance this positivity. The Q&A section does not provide additional insights, leaving some uncertainty. Overall, the sentiment is neutral, with no strong catalysts for a significant stock price movement.
Protalix BioTherapeutics, Inc. (PLX) Q4 2025 Earnings Call Transcript
Unknown3-18
The earnings call presented mixed signals. Financial performance showed a decrease in revenues and a net loss, but optimistic guidance and strategic initiatives like Elfabrio's rollout and PRX-115 development are promising. The Q&A highlighted potential market opportunities and competitive advantages, yet management's lack of specifics on timelines and targets raises uncertainties. The positive milestone payment and strategic focus on high unmet needs balance the negative financials and manufacturing issues. Overall, the sentiment is neutral due to balanced positives and negatives, with no market cap data to assess potential volatility.
Protalix BioTherapeutics, Inc. (PLX) Q3 2025 Earnings Call Transcript
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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.
Protalix BioTherapeutics, Inc. (PLX) Q2 2025 Earnings Call Transcript
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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.
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