olivLaw · US equity research
Protalix BioTherapeutics, Inc. PLX
Biological Products, (No Diagnostic Substances) · SIC 2836 · Vertical: Biological Products, (No Diagnostic Substances) (SIC 2836)
Protalix BioTherapeutics develops and commercializes therapies for rare diseases based on its proprietary plant cell-based protein expression platform, ProCellEx. The company became profitable in the first half of 2026 as Elfabrio sales grew, and its 2026 revenue guidance is reaffirmed at between 78.0 and 83.0 million USD.
At the close of 04 Nov 2026, Protalix BioTherapeutics, Inc. (PLX) stock was 2.69 USD (+3.07% on the day), with market capitalisation 216.7 m USD, P/E 11.7 on diluted EPS of 0.23 USD over the last 12 months, beta 0.85, 52-week range 1.67–3.15 USD. Latest reported quarter (Q2 2026): revenue of 19.9 m USD (+27.1% YoY), net income of 3.8 m USD (+2,203.0% YoY), diluted EPS 0.05 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 55.4
- strong (55–70)
- Bollinger (20, 2)
- 2.46 – 2.79
- in the upper half of the band · %B 0.70 · band width 12.4%
- SMA 50 / 200
- 2.65 / 2.42
- uptrend (price > SMA50 > SMA200)
- MACD (12, 26, 9)
- -0.01 / -0.02
- MACD above signal
Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).
Performance
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | −0.7% | −2.0% | +1.3 pp | — |
| 3 months | +10.2% | −2.2% | +12.4 pp | — |
| 6 months | +33.2% | +4.3% | +28.9 pp | — |
| Year to date | +49.4% | +10.6% | +38.9 pp | — |
| 1 year | +15.0% | +10.5% | +4.5 pp | +4.8% |
| 3 years | +45.4% | +73.7% | −28.3 pp | −1.0% |
| 5 years | +142.3% | +61.7% | +80.6 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q2 2026 · 30 Jun 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q3 '24 | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 18.0 m | 18.2 m | 10.1 m | 15.7 m | 17.9 m | 9.1 m | 33.8 m | 19.9 m |
| Cost of revenue | 8.4 m | 3.9 m | 8.2 m | 5.9 m | 8.3 m | 4.6 m | 4.1 m | 7.8 m |
| Research & development | 3.0 m | 4.1 m | 3.5 m | 6.0 m | 4.5 m | 5.6 m | 5.4 m | 4.4 m |
| SG&A | 2.6 m | 3.0 m | 2.6 m | 2.6 m | 2.9 m | 3.5 m | 3.1 m | 3.1 m |
| Operating income | 4.0 m | 7.2 m | -4.1 m | 1.2 m | 2.1 m | -4.7 m | 21.1 m | 4.7 m |
| Pre-tax income | 3.8 m | 7.3 m | -3.7 m | 661.0 k | 2.2 m | -4.8 m | 21.1 m | 4.9 m |
| Income tax | 607.0 k | 822.0 k | -113.0 k | 497.0 k | -116.0 k | 728.0 k | 2.8 m | 1.1 m |
| Net income | 3.2 m | 6.5 m | -3.6 m | 164.0 k | 2.4 m | -5.5 m | 18.3 m | 3.8 m |
| Diluted EPS | 0.03 | 0.06 ≈ | -0.05 | 0.00 | 0.03 | -0.07 ≈ | 0.22 | 0.05 |
| Operating cash flow | 4.1 m ≈ | 4.0 m | -5.1 m | -5.2 m ≈ | -3.7 m ≈ | 2.0 m | 22.0 m | -10.4 m ≈ |
| Capex | 87.0 k ≈ | 425.0 k | 306.0 k | 431.0 k ≈ | 498.0 k ≈ | 403.0 k | 761.0 k | 593.0 k ≈ |
≈ derived quarter (cumulative difference / share-days average)
E/P over time
E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.
Today's P/E sits at the 10 percentile of its own 10-quarter history (min 10.1, median 35.5, max 800.6; quarters with earnings only).
Fiscal years
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 34.2 m | 54.7 m | 62.9 m | 38.4 m | 47.6 m | 65.5 m | 53.4 m | 52.7 m |
| Revenue YoY | +62.4% | +59.7% | +15.0% | −39.0% | +24.2% | +37.5% | −18.5% | −1.2% |
| Net income | -26.5 m | -18.3 m | -6.5 m | -27.6 m | -14.9 m | 8.3 m | 2.9 m | -6.6 m |
| Net income YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | −64.7% | −325.2% |
| Diluted EPS | unavailable | -1.23 | -0.22 | -0.62 | -0.31 | 0.09 | 0.04 | -0.08 |
| Diluted EPS YoY | unavailable | unavailable | unavailable | unavailable | unavailable | unavailable | −55.6% | −300.0% |
| net % | -77.3% | -33.4% | -10.4% | -71.9% | -31.3% | 12.7% | 5.5% | -12.5% |
| Free cash flow | -8.4 m | -20.0 m | -26.8 m | -11.7 m | -25.6 m | -2.5 m | 7.4 m | -13.6 m |
Reported results vs expectations
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Balance sheet & financial health
Fiscal year 2025 · 31 Dec 2025
- Cash
- 14.7 m USD
- Financial debt
- unavailable USD
- Net debt
- unavailable USD
- Equity
- 48.2 m USD
- Total assets
- 82.3 m USD
- Debt / equity
- unavailable
- Current ratio
- 2.51x
- ROE
- -14.4%
- ROA
- -8.5%
- FCF margin
- -25.8%
Financial statements (source on every figure)
Revenue and net income (USD)
Margins
Income statement · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Revenue | 62.9 m | 38.4 m | 47.6 m | 65.5 m | 53.4 m | 52.7 m | SEC (XBRL)· 18 Mar 2026verified |
| Cost of revenue | 10.9 m | 16.3 m | 19.6 m | 23.0 m | 24.3 m | 27.0 m | SEC (XBRL)· 18 Mar 2026verified |
| Gross profit | 52.0 m ≈ | 22.0 m ≈ | 28.0 m ≈ | 42.5 m ≈ | 29.1 m ≈ | 25.8 m ≈ | SEC (XBRL)· 18 Mar 2026derived |
| Research & development | 38.2 m | 29.7 m | 29.3 m | 17.1 m | 13.0 m | 19.6 m | SEC (XBRL)· 18 Mar 2026verified |
| SG&A | 11.1 m | 12.7 m | 11.7 m | 15.0 m | 12.2 m | 11.7 m | SEC (XBRL)· 18 Mar 2026verified |
| Operating income | 2.7 m | -20.5 m | -13.0 m | 10.5 m | 3.9 m | -5.5 m | SEC (XBRL)· 18 Mar 2026verified |
| Pre-tax income | -6.5 m | -27.6 m | -14.4 m | 8.6 m | 4.2 m | -5.6 m | SEC (XBRL)· 18 Mar 2026verified |
| Income tax | — | — | 530.0 k | 254.0 k | 1.2 m | 996.0 k | SEC (XBRL)· 18 Mar 2026verified |
| Net income | -6.5 m | -27.6 m | -14.9 m | 8.3 m | 2.9 m | -6.6 m | SEC (XBRL)· 18 Mar 2026verified |
| Diluted EPS | -0.22 | -0.62 | -0.31 | 0.09 | 0.04 | -0.08 | SEC (XBRL)· 18 Mar 2026verified |
| Weighted average diluted shares | 29.1 m | 44.1 m | 48.5 m | 82.4 m | 81.1 m | 78.5 m | SEC (XBRL)· 18 Mar 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Revenue − Cost of revenue.
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 18.3 m | 39.0 m | 17.1 m | 23.6 m | 19.8 m | 14.7 m | SEC (XBRL)· 18 Mar 2026verified |
| Receivables | 2.0 m | 3.4 m | 4.6 m | 5.3 m | 2.9 m | 8.8 m | SEC (XBRL)· 18 Mar 2026verified |
| Inventories | 13.1 m | 18.0 m | 16.8 m | 19.0 m | 21.2 m | 25.7 m | SEC (XBRL)· 18 Mar 2026verified |
| Current assets | 55.7 m | 61.7 m | 44.9 m | 69.9 m | 60.1 m | 66.7 m | SEC (XBRL)· 18 Mar 2026verified |
| Property, plant & equipment, net | 4.8 m | 5.0 m | 4.6 m | 5.0 m | 4.6 m | 4.9 m | SEC (XBRL)· 18 Mar 2026verified |
| Total assets | 67.9 m | 73.7 m | 55.8 m | 84.4 m | 73.4 m | 82.3 m | SEC (XBRL)· 18 Mar 2026verified |
| Accounts payable | 13.9 m | 16.4 m | 12.3 m | 19.6 m | — | — | SEC (XBRL)· 14 Mar 2024verified |
| Current liabilities | 86.5 m | 33.2 m | 32.4 m | 45.5 m | 25.6 m | 26.5 m | SEC (XBRL)· 18 Mar 2026verified |
| Total liabilities | 95.0 m | 79.7 m | 66.4 m | 50.9 m | 30.2 m | 34.1 m | SEC (XBRL)· 18 Mar 2026verified |
| Equity | -27.0 m † | -6.0 m † | -10.6 m † | 33.6 m † | 43.2 m † | 48.2 m † | SEC (XBRL)· 18 Mar 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | -26.1 m | -10.3 m | -25.0 m | -1.3 m | 8.7 m | -12.0 m | SEC (XBRL)· 18 Mar 2026verified |
| Capex | 655.0 k | 1.5 m | 628.0 k | 1.1 m | 1.3 m | 1.6 m | SEC (XBRL)· 18 Mar 2026verified |
| Free cash flow | -26.8 m ≈ | -11.7 m ≈ | -25.6 m ≈ | -2.5 m ≈ | 7.4 m ≈ | -13.6 m ≈ | SEC (XBRL)· 18 Mar 2026derived |
| Investing cash flow | -20.0 m | 18.9 m | -5.0 m | -16.7 m | 4.2 m | -2.4 m | SEC (XBRL)· 18 Mar 2026verified |
| Financing cash flow | 46.5 m | 12.1 m | 8.2 m | 24.7 m | -16.8 m | 9.3 m | SEC (XBRL)· 18 Mar 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
- score weight coverage: 43.8% of at least 60%
A scoring methodology on indicators and valuation, not investment advice.
Closing price
04 Nov 2026Source: olivLaw, closing series
Market cap: 216.7 m USD
Key indicators
Coverage and freshness
Score by group
44% · Insufficient data
Estimated value range
The combined range = the median of the valid methods' low, central and high values; it is not a probability interval and does not cover every result. Envelope of all methods: 5.25 – 9.89 USD.
Valuation assumptions are editorial choices, not measured; beta is not measured.
Method ranges (USD per share)
— — Mid · ▏ Price
Valuation methods
- DCF (discounted cash flow)unavailable · the reported interest expense is far older than the latest period (the filer changed its XBRL tag): a stale figure is not used
- Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
- Peers: P/E5.25 – 9.89 (Mid 6.33)6 companies used · median multiple 27.4x · quartiles 22.8x – 42.9xAGEN, AMGN, ARGX, EXEL, QGEN, TECH
- Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption
Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.
Assumptions (illustrative, editorial)
- Risk-free rate
- 4.3%
- Equity risk premium
- 5.0%
- Beta (default)
- 1.00
- Cost of equity
- 9.3%
- Terminal growth
- 2.5%
Factor scorecard
Insufficient data
Minimum-evidence gate: score weight coverage: 43.8% of at least 60%
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | unavailable | unavailable | — |
| Net margin · Quality | 23.5% | 93 (vs peers) | 14% |
| FCF conversion · Quality | 40.5% | 15 (on a fixed band) | 14% |
| Revenue CAGR 3Y · Growth | 3.5% | 29 (on a fixed band) | 19% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | unavailable | unavailable | — |
| Current ratio · Balance sheet | 2.9x | 100 (on a fixed band) | 10% |
| P/E (TTM) · Valuation | 11.7x | 86 (vs peers) | 24% |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | 3.5% | 44 (on a fixed band) | 19% |
| Shareholder yield (distributions) · Returns | unavailable | unavailable | — |
| Payout ratio (FCF) · Returns | unavailable | unavailable | — |
Factors without a value were dropped; the remaining weights were renormalised.
Score groups
- Balance sheet· partial100/100 · 1/3 factors with a value
- Growth· partial29/100 · 1/2 factors with a value
- Quality54/100 · 2/3 factors with a value
- Returns· partialunavailable · 0/2 factors with a value
- Valuation67/100 · 2/3 factors with a value
A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.
Memo
Protalix BioTherapeutics, Inc. (PLX). Latest full fiscal year: 2025; data up to 2026-06-30.
Figures computed from the financial statements: revenue 52.7 m USD in 2025; YoY growth -1.2%; net margin 23.5%; ROE 31.2%.
The estimated value range is 5.25–9.89 USD per share (median of 1 methods, agreement: single method); assumptions are illustrative. Against the central value of 6.33 USD, the price of 2.69 USD leaves a potential of 135.3% (value / price − 1) and a margin of safety of 57.5% (1 − price / value). The range is the median of the methods' low, central and high values, not a probability interval.
Insufficient data for a verdict (score weight coverage: 43.8% of at least 60%).
Text generated deterministically from the figures shown; no language model. Not investment advice.
What supports the thesis
- Net margin: 23.5%
- Current ratio: 2.9x
- P/E (TTM): 11.7x
- The price is below the estimated value range
What contradicts it
- FCF conversion: 40.5%
- Revenue CAGR 3Y: 3.5%
Not assessed (insufficient data or a ratio without meaning): ROIC, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).
Versus the vertical median
Biological Products, (No Diagnostic Substances) (SIC 2836) · same industry (4-digit SIC) · compared with 39 companies
Multiples and returns vs the median
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| AMGNAmgen Inc. | 249.4 bn | 28.7 | 91.5% | 23.0% | +10.0% | +34% / +71% |
| GILDGilead Sciences, Inc. | 207.7 bn | — | -22.3% | -12.5% | +2.4% | +33% / +119% |
| MRNAModerna, Inc. | 91.2 bn | — | -39.0% | -141.4% | −39.9% | +779% / +194% |
| ARGXArgenx Se | 57.6 bn | 47.6 | 20.2% | — | +254.4% | +2% / +107% |
| RVMDRevolution Medicines, Inc. | 41.6 bn | — | -79.1% | — | unavailable | +150% / +733% |
| BIIBBiogen Inc. | 36.8 bn | 106.4 | 1.9% | 3.4% | +2.2% | +37% / +6% |
| EXELExelixis, Inc. | 17.6 bn | 21.6 | 44.3% | 35.5% | +7.0% | +64% / +232% |
| TECHBio-Techne Corp | 11.4 bn | 62.7 | 9.0% | 15.0% | −0.4% | +13% / +16% |
| QGENQiagen N.V. | 11.0 bn | 26.2 | 11.6% | 20.3% | +5.7% | +6% / +20% |
| IBRXImmunitybio, Inc. | 9.5 bn | — | — | -598.6% | +668.3% | +278% / +143% |
| BEAMBeam Therapeutics Inc. | 2.9 bn | — | -11.3% | -73.9% | +120.0% | +10% / −1% |
| RXRXRecursion Pharmaceuticals, Inc. | 2.4 bn | — | -48.7% | -697.1% | +26.9% | −16% / −43% |
| NVAXNovavax Inc | 1.8 bn | — | — | -59.9% | +64.7% | +51% / +94% |
| TSHATaysha Gene Therapies, Inc. | 1.4 bn | — | -47.1% | -2,728.0% | +17.3% | −8% / +148% |
| INBXInhibrx Biosciences, Inc. | 1.3 bn | — | -1,773.6% | — | +550.0% | +3% / unavailable |
| EVAXEvaxion A | 1.2 bn | — | -100.2% | -102.4% | +125.1% | −50% / −93% |
| GLUEMonte Rosa Therapeutics, Inc. | 923.1 m | — | -42.7% | -560.9% | +63.5% | −33% / +249% |
| PRMEPrime Medicine, Inc. | 901.4 m | — | -373.3% | -4,056.4% | +55.3% | +30% / −32% |
| SLDBSolid Biosciences Inc. | 699.1 m | — | -65.5% | — | −40.6% | +20% / +131% |
| CCCCC4 Therapeutics, Inc. | 383.8 m | — | -48.1% | -289.4% | +1.0% | +15% / +91% |
| AUTLAutolus Therapeutics plc | 367.3 m | — | -133.0% | -238.7% | +644.9% | −2% / −68% |
| AGENAgenus Inc | 313.8 m | 2.6 | — | 69.3% | +10.4% | +53% / −55% |
| SABSSab Biotherapeutics, Inc. | 289.3 m | — | -11.3% | — | −100.0% | −19% / −67% |
| FATEFate Therapeutics Inc | 250.4 m | — | -60.7% | -1,941.1% | −51.2% | +83% / −16% |
| DTILPrecision Biosciences Inc | 226.8 m | — | -112.7% | -85.6% | −50.1% | +49% / −24% |
1- and 3-year price returns: for PLX from daily closes (the same as the performance table), for the other companies from month-end closes.
olivLaw engine forecast
The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.
The engine has no published run for this company yet.
Valuation scenarios (editable assumptions)
Illustrative scenarios
Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.
Estimated price (USD)
| Estimated price | Bear | Base | Bull |
|---|---|---|---|
| 1 years | 1.60 Total return -40% · Per year -40% | 2.84 Total return 5% · Per year 5% | 4.27 Total return 59% · Per year 59% |
| 3 years | 1.52 Total return -43% · Per year -17% | 3.03 Total return 13% · Per year 4% | 5.03 Total return 87% · Per year 23% |
| 5 years | 1.45 Total return -46% · Per year -12% | 3.25 Total return 21% · Per year 4% | 5.91 Total return 120% · Per year 17% |
- Exit P/E± 0.76
- Net margin± 0.53
- Annual revenue growth± 0.44
- Annual dilution± 0.04
AI analysis
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
In brief
Protalix BioTherapeutics develops and commercializes therapies for rare diseases based on its proprietary plant cell-based protein expression platform, ProCellEx. The company became profitable in the first half of 2026 as Elfabrio sales grew, and its 2026 revenue guidance is reaffirmed at between 78.0 and 83.0 million USD 3.
SWOT
Strengths
- The company holds a proprietary plant cell expression platform approved by the FDA, giving it a distinct technology edge in complex protein manufacturing.
- The balance sheet is solid, with no outstanding debt or warrants, and the company became profitable in the first half of 2026 3.
- Partnerships with Pfizer and Chiesi share part of the commercial risk, and milestone revenue can support operations.
Weaknesses
- Revenue depends heavily on two products and on partners who commercialize them, with no direct control over sales.
- Partner orders are uneven, which makes quarterly results hard to forecast.
- Elfabrio carries a boxed warning for hypersensitivity reactions and anaphylaxis, which could limit adoption.
Opportunities
- EU dosing extension to every four weeks and approvals in new markets could open further Elfabrio sales growth.
- Results from the RELEASE study for PRX-115 could validate a new product with potential in gout.
- Focus on rare renal indications may generate new candidates and strategic partnerships.
Threats
- Competition from large ERT producers such as Sanofi and Takeda could limit market share.
- Regional conflict affecting Israel could disrupt production, deliveries or clinical studies.
- Changes in reimbursement or pricing policy in key countries could directly affect product revenue.
Risks
- Dependence on Elfabrio and Elelysohigh
Revenue depends almost entirely on two products, so any failure in their commercialization would have a major impact on the business.
- Safety riskhigh
Hypersensitivity and anaphylaxis, already covered by a boxed warning, could occur or be discovered after approval and reduce sales.
- Volatility of partner ordersmedium
The ordering schedules of Pfizer, Chiesi and Fiocruz do not reflect patient demand and can cause large swings between quarters.
- Israel-related risksmedium
Operations are conducted in Israel, and military conflict and political instability could affect production and operations.
- Development risk for PRX-115medium
The Phase 2 study might not confirm efficacy, and a failure would affect the company's pipeline strategy.
Investment thesis
What would need to be true (bull case)
- If Elfabrio sales keep growing and the 2026 guidance holds, the company could sustain profitability and fund its studies without additional financing.
- A positive RELEASE result for PRX-115 could significantly broaden the portfolio beyond the two existing products.
- Extended patent protection for Elfabrio and the new PRX-115 patent could lengthen the exclusivity period and support long-term value.
What would break the thesis
- If partner orders remain uneven, quarterly revenue could stay volatile and hard to anticipate, and profitability could prove unsustainable.
- If new safety issues emerge for Elfabrio, sales could fall quickly because revenue is concentrated in this product.
- If the RELEASE study does not confirm benefit, the company could remain reliant on a limited portfolio with uncertain growth value.
What to watch
- Top-line results of the Phase 2 RELEASE study for PRX-1152027
- Delivery of 2026 revenue guidance of 78.0 to 83.0 million USD2026
- Elfabrio sales trend to Chiesi and approvals in new marketsnext 10-K
- Cash position and funding needs while studies are ongoingQ1 2027
Products, market & competition
AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.
The business
Protalix is a commercial-stage biopharmaceutical company focused on discovering, developing, producing and commercializing therapies for rare diseases with significant unmet needs 1. It developed ProCellEx, a plant cell-based protein expression system in suspension, and is the first company to gain FDA approval for a protein produced this way 1. Its two commercial products are both enzyme replacement therapies: Elelyso for Gaucher disease and Elfabrio for Fabry disease 1.
The business model relies on partnerships: Pfizer commercializes Elelyso worldwide except Brazil, where Protalix keeps the rights, and Chiesi commercializes Elfabrio while Protalix supplies drug substance and drug product 1. Revenue therefore depends on partner orders, which can be uneven from period to period because they do not necessarily reflect patient demand 1.
On development, the company is focusing on new candidates for rare renal indications, with PRX-115 for uncontrolled gout in the Phase 2 RELEASE study and PRX-119 at the preclinical stage 23. Top-line results for PRX-115 are expected in the second half of 2027 3.
Segments
Market context
The market for Gaucher disease therapies was estimated at 1.65 billion USD in 2025, with very modest annual growth forecast through 2031 1. The Fabry therapy market is more dynamic, with a forecast of about 2.3 billion USD in 2026 and a 6.3% annual growth rate between 2025 and 2031 1.
Both markets are niche, with small patient populations and prevalence estimates that can be imprecise, so the real size of the opportunity could be smaller than assumed 1.
Trends
- Elfabrio dosing expansion in Europetailwind
Approval of the every-four-weeks dosing in the EU could reduce infusion frequency and could support adoption among stable ERT patients 13.
- Partner-order revenue recognitionmixed
Partner orders are uneven, which can make quarterly revenue volatile even when patient demand grows steadily 12.
- Regional tensions affecting Israelheadwind
Because operations are based in Israel, a wider regional conflict could disrupt production, supply chains or clinical trial activity 12.
- Expanded intellectual propertytailwind
The patent term extension for Elfabrio and the new patent for PRX-115 strengthen long-term product protection if maintained 3.
Competitive position
In Gaucher disease, Elelyso competes with Sanofi's Cerezyme and Takeda's Vpriv, and in Fabry disease with agalsidase alfa, agalsidase beta and Amicus's Galafold 1. Elfabrio is one of three marketed ERTs for Fabry, alongside Replagal and Fabrazyme 1.
For uncontrolled gout, PRX-115 would enter a market with other treatment options, and its success will depend on Phase 2 results and its advantages over existing alternatives 13.
- Sanofi GenzymeSNY
Produces Cerezyme for Gaucher disease and Fabrazyme for Fabry disease, competing directly with Elelyso and Elfabrio 1.
- Takeda PharmaceuticalTAK
Markets Vpriv for Gaucher disease and Replagal for Fabry disease, both competing with Protalix products 1.
- Amicus TherapeuticsFOLD
Produces Galafold, an oral therapy for Fabry disease competing in the same treatment segment 1.
- Chiesi Farmaceutici
Exclusive global partner for Elfabrio, controlling commercialization and the distribution channel to patients 1.
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
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News & filings
In the press
No news in our archive over the last 180 days.
SEC filings
- Quarterly report12 Aug 2026
- Current report12 Aug 2026Results of operations · Financial statements and exhibits
- Current report25 Jun 2026Shareholder vote · Financial statements and exhibits
- Current report21 May 2026Regulation FD disclosure · Financial statements and exhibits
- Quarterly report13 May 2026
- Current report13 May 2026Results of operations · Financial statements and exhibits
- Proxy statement30 Apr 2026
- Annual report18 Mar 2026
- Current report18 Mar 2026Results of operations · Financial statements and exhibits
- Current report09 Mar 2026Other events · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Protalix BioTherapeutics, Inc. · 18 Mar 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Protalix BioTherapeutics, Inc. · 12 Aug 2026
- [3] Form 8-K, results release (exhibit 99.1) · SEC / Protalix BioTherapeutics, Inc. · 12 Aug 2026
Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.