Protalix Narrows 9-Month Loss to $1.1M on Revenue Growth

TL;DR

**PLX is showing signs of life with narrowing losses and revenue growth, but watch that cash burn and increased R&D spend closely.**

AI Summary

Protalix BioTherapeutics, Inc. reported a net loss of $1.1 million for the nine months ended September 30, 2025, a significant improvement from the $3.56 million net loss in the same period of 2024. Total revenue for the nine-month period increased to $43.62 million in 2025 from $35.18 million in 2024, driven by a rise in revenues from selling goods to $43.11 million from $34.82 million. However, for the three months ended September 30, 2025, the company posted a net income of $2.36 million, a decrease from $3.24 million in the prior year's comparable quarter, with total revenue slightly down to $17.85 million from $17.96 million. Research and development expenses increased substantially to $13.93 million for the nine months ended September 30, 2025, up from $8.85 million in 2024, reflecting ongoing development of product candidates like PRX-115 and PRX-119. The company's cash and cash equivalents decreased to $13.65 million as of September 30, 2025, from $19.76 million at December 31, 2024, but management believes current liquidity is sufficient for at least 12 months. Strategic outlook includes leveraging its ProCellEx platform for new early-stage product candidates targeting rare and orphan diseases, including renal diseases, and exploring novel platform technologies.

Why It Matters

Protalix's improved nine-month financial performance, despite a quarterly dip, signals potential progress in its commercialization efforts for Elfabrio and Elelyso, which could attract investor interest in the competitive biopharmaceutical market. The increased R&D spending on candidates like PRX-115 and PRX-119 indicates a commitment to pipeline expansion, crucial for long-term growth and competitive positioning against larger pharmaceutical companies. For employees, continued revenue generation and R&D investment suggest job stability and opportunities in a growing company. Customers, particularly those with Fabry and Gaucher diseases, benefit from the ongoing availability and development of specialized treatments, while the broader market watches for successful rare disease drug development.

Risk Assessment

Risk Level: medium — The company reported a net loss of $1.1 million for the nine months ended September 30, 2025, and experienced a significant decrease in cash and cash equivalents from $19.76 million at December 31, 2024, to $13.65 million at September 30, 2025. While management believes current cash is sufficient for 12 months, the substantial increase in R&D expenses to $13.93 million for the nine-month period (up from $8.85 million in 2024) indicates ongoing high expenditure without guaranteed returns, posing a medium-term liquidity risk.

Analyst Insight

Investors should monitor Protalix's cash burn rate and the progress of its pipeline candidates, particularly PRX-115 and PRX-119, to assess the return on increased R&D investment. Consider the impact of the $15.7 million in shares available for sale under the Sales Agreement on potential dilution, and evaluate the company's ability to achieve profitability given its current financial trajectory.

Financial Highlights

debt To Equity

0.55

revenue

$43.62M

operating Margin

-1.9%

total Assets

$82.26M

total Debt

$29.36M

net Income

-$1.1M

eps

-$0.01

gross Margin

48.2%

cash Position

$13.65M

revenue Growth

+24.0%

Revenue Breakdown

Key Numbers

• $1.1M — Net Loss (for the nine months ended September 30, 2025, improved from $3.56M loss in 2024)
• $43.62M — Total Revenue (for the nine months ended September 30, 2025, up from $35.18M in 2024)
• $17.85M — Total Revenue (for the three months ended September 30, 2025, down from $17.96M in 2024)
• $13.93M — Research and Development Expenses (for the nine months ended September 30, 2025, up from $8.85M in 2024)
• $13.65M — Cash and Cash Equivalents (as of September 30, 2025, down from $19.76M at December 31, 2024)
• $15.7M — Common Stock Available for Sale (under the Sales Agreement as of September 30, 2025)
• 80,421,181 — Shares Outstanding (as of November 1, 2025)
• $2.36M — Net Income (for the three months ended September 30, 2025, down from $3.24M in 2024)
• $6.81M — Proceeds from Stock Issuance (under Sales Agreement for nine months ended September 30, 2025)
• $2.42M — Proceeds from Warrants and Options Exercise (for nine months ended September 30, 2025)

Key Players & Entities

• Protalix BioTherapeutics, Inc. (company) — registrant
• H.C. Wainwright & Co., LLC (company) — sales agent for At The Market Offering Agreement
• Pfizer Inc. (company) — licensee for Elelyso worldwide (excluding Brazil)
• Chiesi Farmaceutici S.p.A. (company) — partner for development and commercialization of Elfabrio
• Fundao Oswaldo Cruz (Fiocruz) (company) — licensee for Elelyso in Brazil
• Elfabrio (pegunigalsidase alfa) (product) — approved treatment for Fabry disease
• Elelyso (taliglucerase alfa) (product) — approved treatment for Gaucher disease
• PRX-115 (product) — product candidate for uncontrolled gout
• PRX-119 (product) — product candidate for NETs-related diseases
• Hamas (organization) — terrorist group involved in conflict with Israel

FAQ

Risk Factors

• Declining Cash Position [medium — financial]: Cash and cash equivalents decreased to $13.65 million as of September 30, 2025, from $19.76 million at December 31, 2024. While management believes current liquidity is sufficient for at least 12 months, this trend warrants monitoring, especially given increased R&D spending.
• Increased R&D Investment [medium — operational]: Research and development expenses rose significantly to $13.93 million for the nine months ended September 30, 2025, from $8.85 million in 2024. This substantial increase reflects ongoing development of product candidates like PRX-115 and PRX-119, which carries inherent risks of development delays or failure.
• Revenue Fluctuation in Short Term [low — market]: Total revenue for the three months ended September 30, 2025, was slightly down to $17.85 million from $17.96 million in the prior year's comparable quarter. This indicates potential short-term volatility in revenue streams.
• Dependence on Regulatory Approvals [high — regulatory]: As a biopharmaceutical company, Protalix's success is heavily dependent on obtaining regulatory approvals for its product candidates. Delays or rejections from regulatory bodies like the FDA can significantly impact financial performance and future prospects.
• Net Loss Trend [medium — financial]: Despite an improvement, the company reported a net loss of $1.1 million for the nine months ended September 30, 2025. Continued losses, even if narrowing, can strain financial resources and impact investor confidence.

Industry Context

Protalix BioTherapeutics operates in the competitive biopharmaceutical sector, focusing on rare and orphan diseases. The industry is characterized by high R&D costs, long development cycles, and significant regulatory hurdles. Success hinges on innovation, clinical trial outcomes, and effective commercialization strategies. Key trends include advancements in protein-based therapeutics and a growing demand for treatments for underserved patient populations.

Regulatory Implications

The company's product development pipeline is subject to stringent regulatory review by agencies like the FDA. Any delays in clinical trials or approval processes for candidates like PRX-115 and PRX-119 pose significant risks. Compliance with evolving pharmaceutical regulations and manufacturing standards is critical for market access and sustained operations.

What Investors Should Do

1. Monitor R&D spending and pipeline progress.
2. Analyze cash burn rate and runway.
3. Evaluate revenue diversification and growth drivers.
4. Assess competitive landscape and market penetration for existing/pipeline products.

Key Dates

• 2025-09-30: Nine Months Ended — Reported a net loss of $1.1 million, an improvement from $3.56 million in 2024. Total revenue increased to $43.62 million from $35.18 million. R&D expenses increased to $13.93 million.
• 2025-09-30: Three Months Ended — Reported net income of $2.36 million, a decrease from $3.24 million in 2024. Total revenue was slightly down to $17.85 million from $17.96 million.
• 2025-09-30: Balance Sheet Date — Cash and cash equivalents stood at $13.65 million, down from $19.76 million at year-end 2024. Total assets increased to $82.26 million from $73.42 million.
• 2024-12-31: Previous Year End — Cash and cash equivalents were $19.76 million. Total assets were $73.42 million.

Glossary

ProCellEx platform

A proprietary expression technology used by Protalix BioTherapeutics to produce recombinant proteins. (The company plans to leverage this platform for developing new product candidates targeting rare and orphan diseases.)

Operating lease right of use assets

Assets recognized under accounting standards for leases, representing the right to use an asset for a specified period. (These assets increased significantly from $5.43 million to $7.81 million, indicating expanded use of leased facilities or equipment.)

Deferred income tax asset

A future tax benefit that may be realized from deductible temporary differences, net operating loss carryforwards, or tax credits. (This asset decreased slightly, suggesting potential changes in future tax liabilities or utilization of losses.)

Earnings (Loss) Per Share

The portion of a company's profit allocated to each outstanding share of common stock. (For the nine months ended September 30, 2025, the diluted EPS was -$0.01, reflecting the net loss.)

Year-Over-Year Comparison

Compared to the prior year's nine-month period, Protalix BioTherapeutics has shown significant improvement in its net loss, narrowing it from $3.56 million to $1.1 million, and a substantial revenue increase of 24.0% to $43.62 million. However, this progress is accompanied by a sharp rise in R&D expenses, up from $8.85 million to $13.93 million, reflecting increased investment in product development. The company's cash position has declined from $19.76 million at year-end 2024 to $13.65 million as of September 30, 2025, indicating a higher cash burn rate.

Key Financial Figures

• $0.001 — nge on which registered Common stock, $0.001 par value PLX NYSE American Indic
• $1 — Represents an amount equal to less than $1. (1) Common stock, $ 0.001 par value;

Filing Documents

• plx-20250930x10q.htm (10-Q) — 1125KB
• plx-20250930xex10d1.htm (EX-10.1) — 833KB
• plx-20250930xex31d1.htm (EX-31.1) — 12KB
• plx-20250930xex31d2.htm (EX-31.2) — 12KB
• plx-20250930xex32d1.htm (EX-32.1) — 7KB
• plx-20250930xex32d2.htm (EX-32.2) — 7KB
• plx-20250930x10q005.jpg (GRAPHIC) — 69KB
• plx-20250930x10q006.jpg (GRAPHIC) — 37KB
• plx-20250930x10q007.jpg (GRAPHIC) — 55KB
• plx-20250930x10q008.jpg (GRAPHIC) — 39KB
• 0001104659-25-110824.txt ( ) — 6341KB
• plx-20250930.xsd (EX-101.SCH) — 34KB
• plx-20250930_cal.xml (EX-101.CAL) — 50KB
• plx-20250930_def.xml (EX-101.DEF) — 119KB
• plx-20250930_lab.xml (EX-101.LAB) — 264KB
• plx-20250930_pre.xml (EX-101.PRE) — 207KB
• plx-20250930x10q_htm.xml (XML) — 742KB

– FINANCIAL INFORMATION

PART I – FINANCIAL INFORMATION Item 1.

Financial Statements

Financial Statements Condensed Consolidated Balance Sheets (Unaudited) – As of September 30, 2025 and December 31, 2024 2 Condensed Consolidated Statements of Operations (Unaudited) – For the Nine and Three Months Ended September 30, 2025 and 2024 3 Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) – For the Nine and Three Months Ended September 30, 2025 and 2024 4 Condensed Consolidated Statements of Cash Flows (Unaudited) – For the Nine Months Ended September 30, 2025 and 2024 5 Notes to Condensed Consolidated Financial Statements 7 Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 15 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 32 Item 4.

Controls and Procedures

Controls and Procedures 33

– OTHER INFORMATION

PART II – OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 34 Item 1A.

Risk Factors

Risk Factors 34 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 34 Item 3. Defaults Upon Senior Securities 34 Item 4. Mine Safety Disclosures 34 Item 5. Other Information 34 Item 6. Exhibits 34

Signatures

Signatures 36 Table of Contents

– FINANCIAL INFORMATION

PART I – FINANCIAL INFORMATION

Financial Statements

Item 1. Financial Statements PROTALIX BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) (Unaudited) September 30, 2025 December 31, 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 13,647 $ 19,760 Short-term bank deposits 15,723 15,070 Accounts receivable 14,425 2,909 Other assets 1,452 1,096 Inventories 21,255 21,243 Total current assets $ 66,502 $ 60,078 NON-CURRENT ASSETS: Funds in respect of employee rights upon retirement $ 549 $ 462 Property and equipment, net 4,724 4,591 Deferred income tax asset 2,679 2,856 Operating lease right of use assets 7,810 5,430 Total assets $ 82,264 $ 73,417 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable and accruals: Trade $ 5,375 $ 4,533 Other 15,173 19,588 Operating lease liabilities 1,397 1,500 Total current liabilities $ 21,945 $ 25,621 LONG TERM LIABILITIES: Liability for employee rights upon retirement $ 631 $ 559 Operating lease liabilities 6,780 4,026 Total long term liabilities $ 7,411 $ 4,585 Total liabilities $ 29,356 $ 30,206 COMMITMENTS STOCKHOLDERS' EQUITY 52,908 43,211 Total liabilities and stockholders' equity $ 82,264 $ 73,417 The accompanying notes are an integral part of the condensed consolidated financial statements. 2 Table of Contents PROTALIX BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) (Unaudited) Nine Months Ended Three Months Ended September 30, 2025 September 30, 2024 September 30, 2025 September 30, 2024 REVENUES FROM SELLING GOODS $ 43,108 $ 34,820 $ 17,673 $ 17,839 REVENUES FROM LICENSE AND R&D SERVICES 514 361 178 120 TOTAL REVENUE 43,622 35,181 17,851 17,959 COST OF GOODS SOLD ( 22,374 ) ( 20,433 ) ( 8,324 ) ( 8,375 ) RESEARCH AND DEV

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