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Protalix Biotherapeutics (PLX)
XASE:PLX

Protalix (PLX) AI Stock Analysis

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PLX

Protalix

(NYSE MKT:PLX)

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Neutral 59 (OpenAI - 5.2)
Rating:59Neutral
Price Target:
$2.00
▼(-4.76% Downside)
The score is driven primarily by improved profitability and a healthier balance sheet, but is held back by deteriorating TTM cash flow and shrinking revenue. Earnings-call updates were supportive (strong YTD revenue growth, positive quarterly income, adequate near-term cash) while technicals are modestly positive and valuation remains somewhat demanding.
Positive Factors
Balance Sheet Health
Protalix's capitalization has materially improved versus 2020–2022: positive equity and low debt reduce financial risk and improve funding flexibility. This stronger balance sheet supports sustained R&D and partnership investments and lowers refinancing pressure over the next 2–6 months.
Commercial Partnerships & Revenue Diversity
Long-term commercial partnerships (Pfizer, Fiocruz, Chiesi) provide predictable, durable revenue streams that de-risk the business model. Partner-supported product sales help stabilize cash flow while management advances pipeline assets, supporting operational resilience over multiple quarters.
Pipeline Advancement (PRX-115)
IND filing and Phase 2 initiation for PRX-115 represent a structural progression from discovery to mid-stage development. Successful clinical advancement can create a third commercial asset, diversify future revenue and justify elevated R&D, affecting company fundamentals over the medium term.
Negative Factors
Negative Trailing Cash Flow
Despite recent net income, TTM operating and free cash flow have swung negative, indicating cash burn or working-capital strain. Persistent negative cash conversion can erode reserves, force external financing, and constrain strategic flexibility across the coming quarters if not reversed.
Declining Revenue Trend
Sustained top-line declines weaken the revenue base that underpins margins and investment capacity. Continued shrinkage pressures margin sustainability and increases reliance on partnerships or cost reductions to maintain profitability, making growth recovery a key medium-term risk.
Regulatory Uncertainty for Elfabrio in Europe
A negative CHMP opinion on a four-week dosing regimen and pending re-examination create substantive regulatory risk for Elfabrio's label expansion in Europe. This uncertainty can limit market access, constrain peak uptake and partner commercial plans, affecting European revenue prospects over coming quarters.

Protalix (PLX) vs. SPDR S&P 500 ETF (SPY)

Protalix Business Overview & Revenue Model

Company DescriptionProtalix BioTherapeutics, Inc., a biopharmaceutical company, focuses on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx plant cell-based protein expression system in the United States, Australia, Canada, Israel, Brazil, Russia, Turkey, and internationally. The company offers Elelyso for the treatment of Gaucher disease. Its product pipeline comprises PRX-102, a therapeutic protein candidate, which is in the last stage of clinical trials for the treatment of Fabry diseases; PRX-110, a proprietary plant cell recombinant form of human deoxyribonuclease I that has completed phase IIa clinical trials for the treatment of cystic fibrosis; PRX-115, a plant cell-expressed recombinant PEGylated Uricase for the treatment of gout; and PRX-119, a plant cell-expressed PEGylated recombinant human DNase I product candidate for the treatment of NETs-related diseases. The company has agreements and partnerships with Pfizer; Fundação Oswaldo Cruz (Fiocruz); and Chiesi Farmaceutici S.p.A. The company was founded in 1993 and is based in Hackensack, New Jersey.
How the Company Makes MoneyProtalix generates revenue primarily through the sale of its products, notably Elelyso, which is marketed in collaboration with partners such as Pfizer. The company earns revenue from product sales, licensing agreements, and potential royalties from its collaborative partners. Additionally, Protalix may engage in research and development agreements with other companies or institutions, providing another revenue stream. Their financial performance is influenced by the successful commercialization of their therapies and the achievement of milestones in partnerships.

Protalix Earnings Call Summary

Earnings Call Date:Nov 13, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 12, 2026
Earnings Call Sentiment Neutral
The earnings call highlighted strong year-to-date revenue growth and advancement in clinical trials, alongside a positive Q3 net income and solid cash position. However, there were challenges, including a slight decrease in Q3 revenue, increased R&D expenses, and regulatory uncertainty regarding Elfabrio's dosing regimen in Europe.
Q3-2025 Updates
Positive Updates
Strong Year-to-Date Revenue Growth
For the first nine months of 2025, total revenues were $46.436 million, representing a 24% increase compared to the same period last year.
Advancement of PRX-115 Clinical Trial
Preparation for the phase two clinical trial of PRX-115 is well underway, with the IND filed in October and plans to initiate the trial later this year.
Positive Net Income for Q3 2025
For the three months ended September 30, 2025, net income was approximately $2.4 million or 3¢ per share, basic and diluted.
Strong Cash Position
As of September 30, 2025, the company had $29.4 million in cash and cash equivalents and short-term bank deposits, sufficient for at least twelve months.
Negative Updates
Decrease in Q3 Revenue
Total revenues for the third quarter of 2025 were $17.9 million, reflecting a decrease of 1% compared to the same period in 2024.
Increased R&D Expenses
Research and development expenses for the nine months ended September 30, 2025, totaled $13.9 million, an increase of $5.1 million or 58% compared to the same period last year.
Pending CHMP Reexamination
The company is awaiting a decision in 2026 regarding the reexamination request submitted for the once every four weeks dosing regimen of Elfabrio in Europe.
Company Guidance
During the Protalix BioTherapeutics, Inc. third-quarter 2025 financial results call, the company reported total revenues of $46.436 million for the first nine months of 2025, marking a 24% increase from the previous year. Third-quarter revenues were $17.9 million, a slight 1% decrease from 2024. Sales comprised $18.6 million from Elfabrio to Chiesi, $15.4 million from Elelyso to Pfizer, and $9.1 million from Elelyso in Brazil. The company highlighted ongoing regulatory efforts with Chiesi to reexamine the CHMP's negative opinion on Elfabrio's four-week dosing regimen, while maintaining confidence in its approved two-week regimen. Protalix is advancing its PRX-115 candidate for uncontrolled gout, with a phase two trial set to initiate soon. Financially, the company has a net income of $2.4 million for the quarter, with $29.4 million in cash reserves, supporting operations for at least twelve months. Research and development expenses rose by 58% to $13.9 million, driven by pipeline investments. Gilad Mamluk, the new CFO, underscored financial discipline and revenue predictability, despite inventory fluctuations impacting quarterly sales.

Protalix Financial Statement Overview

Summary
Protalix has shown significant improvement in profitability and cash flow generation, which are crucial for its financial stability. However, inconsistent revenue growth and high leverage remain concerns.
Income Statement
The company has demonstrated a positive turnaround in profitability over the last few years. Gross profit margins have been healthy, and there was a notable improvement in net income, moving from losses to profits recently. However, revenue growth has been inconsistent with a decline in the latest period, and EBIT margins are still relatively low, indicating room for operational improvements.
Balance Sheet
Protalix's balance sheet shows a significant reduction in total debt, which is a positive sign for financial health. The equity position has improved from negative to positive, enhancing the equity ratio. However, the debt-to-equity ratio is still high, indicating potential leverage risks. The company needs to continue strengthening its equity to mitigate these risks further.
Cash Flow
The company has shown a strong improvement in cash flow, moving from negative free cash flow to positive in the latest period. The operating cash flow to net income ratio indicates a healthy conversion of profits into cash. However, the free cash flow growth rate is volatile, suggesting potential fluctuations in cash generation capabilities.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue61.84M53.40M65.49M47.64M38.35M62.90M
Gross Profit35.58M29.08M42.51M28.05M22.00M52.02M
EBITDA8.87M6.52M12.94M-10.78M-18.94M4.45M
Net Income5.39M2.93M8.31M-14.93M-27.58M-6.52M
Balance Sheet
Total Assets82.26M73.42M84.43M55.79M73.67M67.93M
Cash, Cash Equivalents and Short-Term Investments29.37M34.83M44.56M22.18M38.98M38.55M
Total Debt8.18M5.53M27.69M33.47M33.47M64.40M
Total Liabilities29.36M30.21M50.87M66.43M79.70M94.97M
Stockholders Equity52.91M43.21M33.57M-10.64M-6.04M-27.04M
Cash Flow
Free Cash Flow-11.69M7.39M-2.47M-25.63M-11.74M-26.76M
Operating Cash Flow-10.03M8.67M-1.32M-25.00M-10.29M-26.11M
Investing Cash Flow-16.57M4.22M-16.71M-5.04M18.92M-19.95M
Financing Cash Flow12.81M-16.79M24.67M8.24M12.08M46.47M

Protalix Technical Analysis

Technical Analysis Sentiment
Positive
Last Price2.10
Price Trends
50DMA
1.89
Positive
100DMA
1.96
Positive
200DMA
1.91
Positive
Market Momentum
MACD
0.03
Negative
RSI
67.26
Neutral
STOCH
88.28
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PLX, the sentiment is Positive. The current price of 2.1 is above the 20-day moving average (MA) of 1.82, above the 50-day MA of 1.89, and above the 200-day MA of 1.91, indicating a bullish trend. The MACD of 0.03 indicates Negative momentum. The RSI at 67.26 is Neutral, neither overbought nor oversold. The STOCH value of 88.28 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for PLX.

Protalix Risk Analysis

Protalix disclosed 64 risk factors in its most recent earnings report. Protalix reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Protalix Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
59
Neutral
$166.47M30.2212.64%35.42%
56
Neutral
$492.85M-14.33-84.33%59.04%
56
Neutral
$299.14M-6.67-110.72%77.08%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
49
Neutral
$166.48M-3.05-271.32%-75.77%-31.24%
48
Neutral
$296.88M-3.63-49.42%48.84%
47
Neutral
$204.27M-72.54%-19972.15%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
PLX
Protalix
2.10
-0.07
-3.23%
CHRS
Coherus Biosciences
1.65
0.19
13.01%
SLS
SELLAS Life Sciences Group
4.11
3.14
323.71%
TARA
Protara Therapeutics
5.24
0.57
12.21%
FBRX
Forte Biosciences
29.66
13.16
79.76%
IPHA
Innate Pharma
1.82
0.12
7.06%

Protalix Corporate Events

Business Operations and StrategyFinancial DisclosuresRegulatory Filings and Compliance
Protalix outlines 2026 rare-disease growth and pipeline strategy
Positive
Jan 5, 2026

On January 5, 2026, Protalix BioTherapeutics released a letter to stockholders outlining its strategy to build a growing, profitable rare-disease business anchored by commercial partnerships and an expanding pipeline. Management highlighted solid 2025 commercial execution with partner Chiesi for Elfabrio in Fabry disease, with patient metrics and market share in the U.S., EU and other markets tracking to plan, and reiterated expectations that Elfabrio could capture 15–20% of a global Fabry market projected at about $3.4 billion by 2030. The company noted that a re-examination of the European regulator’s November 2025 negative opinion on an every‑four‑weeks Elfabrio dosing regimen is underway, with an appeal decision expected in the first quarter of 2026, while the existing bi‑weekly label remains unaffected. Protalix also pointed to steady, durable revenue contributions from Elelyso through its partnerships with Pfizer and Brazil’s Fiocruz as key supports for operating resilience. On the pipeline side, Protalix emphasized PRX‑115 for uncontrolled gout as a potential third commercial molecule, citing Phase 1 data showing rapid, durable urate-lowering with a favorable tolerability profile and the October 2025 U.S. IND clearance enabling a Phase 2 trial with initial sites already activated. In parallel, the company is sharpening its focus on rare kidney diseases, advancing PRX‑119, a long‑acting DNase I candidate targeting inflammation and fibrosis, and pursuing an AI‑enabled RNA-based collaboration with Secarna Pharmaceuticals to develop novel therapies for rare renal indications. Entering 2026, Protalix framed its outlook around three priorities: supporting Chiesi’s Elfabrio commercialization, advancing PRX‑115 in uncontrolled gout, and progressing its rare renal programs, aiming to limit downside risk while preserving meaningful upside for patients, partners and shareholders.

The most recent analyst rating on (PLX) stock is a Buy with a $12.00 price target. To see the full list of analyst forecasts on Protalix stock, see the PLX Stock Forecast page.

Product-Related AnnouncementsRegulatory Filings and Compliance
Protalix Seeks EMA Re-examination for Elfabrio Dosing
Neutral
Nov 3, 2025

On November 3, 2025, Protalix BioTherapeutics and Chiesi Global Rare Diseases announced their request for a re-examination of the European Medicines Agency’s negative opinion on the proposed dosing regimen for Elfabrio, a treatment for Fabry disease. The existing marketing authorization for Elfabrio remains in effect while the re-examination is underway, highlighting the companies’ commitment to addressing the needs of the Fabry community.

The most recent analyst rating on (PLX) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Protalix stock, see the PLX Stock Forecast page.

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Protalix Faces EMA Setback on Elfabrio® Dosing
Negative
Oct 17, 2025

On October 17, 2025, Protalix BioTherapeutics and its partner Chiesi Global Rare Diseases announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the proposed dosing regimen for Elfabrio®. This decision may impact the company’s market strategy and regulatory approach for Elfabrio® in Europe, potentially affecting stakeholders and future commercial plans.

The most recent analyst rating on (PLX) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on Protalix stock, see the PLX Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jan 09, 2026