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1. Company Snapshot

1.a. Company Description

Protalix 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.

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1.b. Last Insights on PLX

Protalix BioTherapeutics' recent performance was driven by strong revenue growth, fueled by increasing demand for its Fabry disease treatment, Elfabrio. The company's Q2 2025 revenue rose 16% to $15.4 million, driven largely by Elfabrio sales to Chiesi. Additionally, the company's inclusion in the Russell 3000 and Russell 2000 Indexes, effective June 27, 2025, enhanced its visibility. A speculative buy rating from an analyst highlights the company's promising plant-cell platform and Elfabrio's growth potential (Source: August 25, 2025, research report).

1.c. Company Highlights

2. Protalix BioTherapeutics' Earnings Report: A Mixed Bag

Protalix BioTherapeutics reported total revenues of $46.436 million for the first nine months of 2025, a 24% increase compared to the same period last year. However, the company's third-quarter revenues were $17.9 million, a 1% decrease from the same period in 2024. The actual EPS came out at $0.03, missing estimates of $0.06. Despite the revenue growth, the company's financial performance was impacted by varying purchases from quarter to quarter by its partners, including Chiesi, Pfizer, and Fiocruz in Brazil.

Publication Date: Nov -20

📋 Highlights
  • Revenue Growth and Decline:: Total revenues for the first nine months of 2025 reached $46.436 million (+24% YoY), but Q3 2025 revenues fell to $17.9 million (-1% YoY).
  • Regulatory Update on Elfabrio:: Chiesi requested reexamination of the CHMP’s negative opinion for the every-four-weeks dose; the every-two-weeks regimen remains approved and available in the EU.
  • PRX-115 Pipeline Progress:: Phase 2 trial preparation ongoing with IND filed in October 2025; trial expected to start later in 2025, with top-line results anticipated in 2027.
  • Financial Position:: $29.4 million in cash as of September 30, 2025, sufficient to fund operations for at least 12 months, including the PRX-115 trial.
  • Cash Runway and Guidance:: Management reiterated sufficient liquidity to cover 2026 cash burn for R&D and SG&A, excluding formal guidance due to Chiesi’s variable inventory purchases impacting revenue.

Regulatory Update and Pipeline Progress

On the regulatory front, Protalix is working closely with Chiesi to reexamine the negative opinion issued by the CHMP regarding the proposed every four weeks dose regimen for Elfabrio in Europe. The company is also advancing its pipeline, particularly PRX-115, a recombinant pegylated uricase candidate for the potential treatment of uncontrolled gout. As Gilad Mamluk noted, "they have enough cash for over 12 months to fund the PRX-115 trial," indicating a strong cash position to support its R&D initiatives.

Cash Position and Operating Strategy

Protalix had $29.4 million in cash and cash equivalents as of September 30, 2025, sufficient to satisfy its capital needs for at least twelve months. The company's operating strategy remains focused on driving commercial success with Elfabrio, advancing PRX-115 and other pipeline programs, and maintaining financial discipline. With a strong cash position and positive quarterly net income, Protalix is well-positioned to execute on these priorities.

Valuation and Growth Prospects

Analysts estimate next year's revenue growth at 75.8%, indicating a significant increase in sales. The company's current valuation metrics, including a P/S Ratio of 2.3 and an EV/EBITDA of 15.75, suggest that the market is pricing in some growth expectations. However, the actual EPS miss and the decline in third-quarter revenues may impact the stock's performance in the short term. With a ROE of 10.12% and an ROIC of 8.58%, Protalix is generating returns on its investments, but the Free Cash Flow Yield is negative at -8.21%, indicating that the company is not generating cash from its operations.

3. NewsRoom

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Protalix BioTherapeutics, Inc. (PLX) Q3 2025 Earnings Call Transcript

Nov -13

Source: seekingalpha.com

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Protalix BioTherapeutics Reports Third Quarter 2025 Financial and Business Results

Nov -13

Source: prnewswire.com

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PLX Investors Have Opportunity to Join Protalix BioTherapeutics, Inc. Fraud Investigation with the Schall Law Firm

Nov -05

Source: globenewswire.com

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Protalix and Chiesi seek EMA re-examination of Elfabrio dosing opinion

Nov -04

Source: proactiveinvestors.com

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Chiesi Global Rare Diseases and Protalix BioTherapeutics Seek Re-examination from the EMA for the Negative Opinion for Elfabrio (pegunigalsidase alfa) Alternative Dosing Regimen of Every Four Weeks in the EU

Nov -03

Source: globenewswire.com

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PLX Investors Have Opportunity to Join Protalix BioTherapeutics, Inc. Fraud Investigation with the Schall Law Firm

Nov -01

Source: businesswire.com

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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Protalix BioTherapeutics, Inc. - PLX

Oct -28

Source: prnewswire.com

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Protalix BioTherapeutics (NYSE:PLX) vs. Invizyne Technologies (NASDAQ:IZTC) Critical Survey

Oct -26

Source: defenseworld.net

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (9.27%)

6. Segments

Recombinant Therapeutic Proteins

Expected Growth: 9.27%

Protalix BioTherapeutics' 9.27% growth in Recombinant Therapeutic Proteins is driven by increasing demand for rare genetic disorder treatments, expanding product pipeline, and strategic partnerships. Additionally, advancements in plant-based protein expression technology and growing adoption of biosimilars contribute to the segment's growth.

7. Detailed Products

Elelyso

A plant-cell expressed recombinant glucocerebrosidase enzyme replacement therapy for the treatment of Gaucher disease.

PRX-102

A novel, plant-cell expressed recombinant alpha-galactosidase-A enzyme replacement therapy for the treatment of Fabry disease.

PRX-110

A novel, plant-cell expressed recombinant human deoxyribonuclease I (rhDNase) for the treatment of cystic fibrosis.

PRX-115

A novel, plant-cell expressed recombinant human lysosomal acid lipase (rhLAL) for the treatment of lysosomal acid lipase deficiency.

8. Protalix BioTherapeutics, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

Protalix BioTherapeutics, Inc. has a moderate threat of substitutes due to the availability of alternative treatments for Fabry disease and Gaucher disease.

Bargaining Power Of Customers

Patients and healthcare providers have limited bargaining power due to the specialized nature of Protalix BioTherapeutics, Inc.'s products and the lack of alternative treatments.

Bargaining Power Of Suppliers

Protalix BioTherapeutics, Inc. has a moderate bargaining power of suppliers due to the availability of multiple suppliers for raw materials and manufacturing services.

Threat Of New Entrants

The threat of new entrants is low due to the high barriers to entry in the biotechnology industry, including the need for significant research and development investments and regulatory approvals.

Intensity Of Rivalry

The intensity of rivalry is high due to the presence of established competitors in the biotechnology industry, including Sanofi Genzyme and Shire, and the ongoing competition for market share.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 43.91%
Debt Cost 8.45%
Equity Weight 56.09%
Equity Cost 8.45%
WACC 8.45%
Leverage 78.29%

11. Quality Control: Protalix BioTherapeutics, Inc. passed 3 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
Lineage Cell Therapeutics

A-Score: 4.5/10

Value: 6.2

Growth: 6.0

Quality: 4.6

Yield: 0.0

Momentum: 9.5

Volatility: 1.0

1-Year Total Return ->

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Stock-Card
Protalix BioTherapeutics

A-Score: 4.3/10

Value: 4.1

Growth: 6.6

Quality: 8.2

Yield: 0.0

Momentum: 5.0

Volatility: 1.7

1-Year Total Return ->

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Seres Therapeutics

A-Score: 4.1/10

Value: 6.4

Growth: 4.6

Quality: 6.1

Yield: 0.0

Momentum: 7.0

Volatility: 0.7

1-Year Total Return ->

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Voyager Therapeutics

A-Score: 3.4/10

Value: 7.8

Growth: 4.8

Quality: 5.0

Yield: 0.0

Momentum: 1.0

Volatility: 2.0

1-Year Total Return ->

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4D Molecular Therapeutics

A-Score: 2.9/10

Value: 7.0

Growth: 1.3

Quality: 3.6

Yield: 0.0

Momentum: 4.5

Volatility: 1.0

1-Year Total Return ->

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Stock-Card
MediciNova

A-Score: 2.9/10

Value: 7.2

Growth: 4.6

Quality: 3.1

Yield: 0.0

Momentum: 0.5

Volatility: 2.0

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

1.73$

Current Price

1.73$

Potential

-0.00%

Expected Cash-Flows