Protalix BioTherapeutics Reports Fiscal Year 2025 Financial and Business Results
Rhea-AI Summary
Protalix (NYSE:PLX) reported fiscal 2025 results and business updates on March 18, 2026. Key developments include EC approval of a 2mg/kg every‑4‑weeks (E4W) Elfabrio dosing regimen for adults with Fabry disease, triggering a $25.0 million milestone from Chiesi and supporting an expected $50.0 million cash balance by April 2026.
Management expects 2026 revenue of $78.0–$83.0 million (including the milestone), announced active enrollment in the Phase 2 PRX‑115 gout trial, and highlighted focus on rare renal programs and partnerships.
Positive
- EC approval of Elfabrio E4W dosing, unique ERT label in EU
- $25.0M milestone from Chiesi triggered by EC approval
- 2026 revenue guidance of $78.0–$83.0M including milestone
- Phase 2 PRX‑115 trial actively enrolling; top-line expected H2 2027
Negative
- Net loss of $6.6M in 2025 (vs. net income $2.9M in 2024)
- Revenues from selling goods fell 2% YoY to $51.8M in 2025
- Cost of goods sold rose 11% to $27.0M in 2025
- R&D expenses increased 51% to $19.6M in 2025
News Market Reaction – PLX
On the day this news was published, PLX declined 20.79%, reflecting a significant negative market reaction. Argus tracked a trough of -10.7% from its starting point during tracking. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $59M from the company's valuation, bringing the market cap to $224M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PLX was down 2.79% while close peers showed mixed moves (e.g., INO down, MCRB up), and only one peer appeared in momentum data, pointing to a stock-specific reaction rather than a sector-wide biotech move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 13 | Q3 2025 earnings | Positive | -9.8% | Q3 update with higher YTD revenue and PRX‑115 Phase 2 preparations. |
| Aug 14 | Q2 2025 earnings | Positive | -5.6% | Strong Q2 revenue growth and return to net income plus index inclusion. |
| May 09 | Q1 2025 earnings | Positive | -40.5% | Sharp revenue growth from goods with narrowed net loss and higher R&D. |
| Mar 17 | FY 2024 earnings | Positive | +9.4% | Record 2024 goods revenue, debt repayment, and positive PRX‑115 data. |
| Nov 14 | Q3 2024 earnings | Positive | +13.7% | Strong Q3 2024 growth, net income, and promising PRX‑115 Phase 1 data. |
Across recent earnings, PLX often showed negative or volatile next-day moves despite operational progress, with an average move of about -6.56% on earnings-type headlines.
Over the past year, PLX’s earnings and financial updates have highlighted growing product revenues, swings between net income and net loss, and rising R&D investment around PRX‑115. Events include strong FY 2024 results with record goods revenue, profitable quarters in 2024–2025, and subsequent heavier R&D spend as Phase 2 plans advanced. Regulatory developments around Elfabrio’s less-frequent dosing and the Fabry franchise have also been recurring themes. Today’s FY 2025 report and 2026 revenue outlook extend this pattern of commercial growth paired with pipeline reinvestment.
Historical Comparison
Over the last five earnings-related releases, PLX’s average next-day move was -6.56%, often skewing negative despite operational progress, framing expectations for market response to these FY 2025 results and guidance.
Earnings updates show PLX progressing from strong FY 2024 revenue growth and profitability, through 2025 quarters marked by rising R&D for PRX‑115, to today’s FY 2025 results that pair an EC-approved Elfabrio regimen with detailed 2026 revenue guidance.
Regulatory & Risk Context
PLX has an amended Form S-3/A shelf registration dated 2025-08-14, with at least one usage via a 424B5 prospectus in 2025. The amendment updated auditor consent, while the underlying prospectus terms remained unchanged. Specific capacity details are not provided here.
Market Pulse Summary
The stock dropped -20.8% in the session following this news. A negative reaction despite regulatory and guidance positives fits PLX’s history, where earnings-related releases averaged about -6.56% next-day moves. FY 2025 included a $6.6 million net loss and a slight decline in goods revenue to $51.8 million, which could reinforce caution. The outlook for 2026 revenues of $78.0–$83.0 million and the $25.0 million milestone may help frame longer-term potential, but execution and trial risk around PRX‑115 remain key variables.
Key Terms
enzyme replacement therapy (ERT) medical
Committee for Medicinal Products for Human Use (CHMP) regulatory
Population Pharmacokinetics (PopPK) medical
exposure–response analysis medical
Phase 2 clinical trial medical
recombinant PEGylated uricase medical
long–term extension medical
AI-generated analysis. Not financial advice.
Company to host conference call and webcast today at 8:00 a.m. EDT
- The European Commission (EC) approved the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® in adults living with Fabry disease providing a meaningful reduction in treatment burden without compromising efficacy
- The EC approval triggered the Company's entitlement to a
$25.0 million $50.0 million - Based on current estimates, management expects total revenues in 2026 to range from approximately
$78.0 million $83.0 million $25.0 million - The Phase 2 clinical trial of PRX–115 is actively enrolling; the Company believes PRX-115 has the potential to be a best-in-class therapy, improving uncontrolled gout patients' compliance and outcomes
- Continued strategic focus on rare renal diseases to build a pipeline through innovation and partnerships
CARMIEL,
"2025 was a year of meaningful progress for Protalix, marked by strong commercial execution with our partners and important advances and strategic direction across our clinical and preclinical pipeline," said Dror Bashan, President and Chief Executive Officer, Protalix BioTherapeutics. "The EC approval of the E4W dosing regimen for Elfabrio in the European Union represents an advancement for patients by reducing treatment burden without compromising efficacy. This milestone strengthens the long–term value of our Fabry franchise. In parallel, we believe the ongoing development of PRX–115 positions us to address the substantial unmet need in uncontrolled gout with a potential best–in–class therapy. We are also sharpening our focus on rare renal diseases with PRX–119 and our RNA–based discovery collaboration with Secarna, leveraging the capabilities of our ProCellEx® platform. As we enter 2026, we remain committed to driving profitable growth, expanding opportunities across our portfolio, and delivering innovative therapies that meaningfully improve the lives of patients with rare diseases."
Recent Business Highlights
Elfabrio for Fabry Disease - E4W regimen provides meaningful reduction in treatment burden in EU
- In March 2026, the European Commission (EC) approved a novel 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio in adults with Fabry disease who are stable on an enzyme replacement therapy (ERT).
- This decision followed the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending this additional dosing regimen.
- The E4W regimen provides a potentially meaningful reduction in treatment burden without comprising efficacy, one of the more common unmet needs in Fabry disease, and the
50% infusion frequency reduction represents a quality of life improvement for Fabry patients in the EU. - This approval was supported by the BRIGHT study and long-–term extension data, which demonstrated that the E4W dosing regimen maintained clinical and renal outcomes in stable patients.
- Further support came from an updated Population Pharmacokinetics (PopPK) model and exposure–response analysis, which leveraged data from multiple clinical studies.
- Elfabrio is now the only ERT approved for E4W dosing to treat Fabry in the EU – strengthening its competitive positioning and potential market share expansion.
- The FDA-approved dosing regimen for Elfabrio in
the United States remains 1mg/kg every 2 weeks.
PRX-115 for Uncontrolled Gout – Phase 2 trial actively enrolling
- Actively enrolling, and the first patients have been randomized, in the RELEASE Phase 2 clinical trial of PRX–115 (NCT07280156), a recombinant PEGylated uricase.
- The RELEASE study builds on favorable Phase 1 clinical trial results, where PRX–115 was generally well–tolerated and demonstrated rapid, durable serum urate reduction below target levels across all cohorts.
- PRX–115 is designed as a potential best–in–class, long–acting therapy, with a possible E4W dosing schedule with or without an immunomodulator, or less frequent dosing with an immunomodulator, aiming to improve adherence and durability of response for patients with uncontrolled gout.
- By addressing immunogenicity challenges and enabling more flexible dosing intervals, the Company believes PRX–115 is well-positioned to capture a meaningful share in the uncontrolled gout segment, where even modest penetration represents significant commercial opportunity.
- The Company anticipates top-line results in the second half of 2027.
- The Company recently received an allowance from the US Intellectual Property Office (USPTO) for Patent Application No. 18/035,149 entitled "MODIFIED URICASE AND USES THEREOF" protecting the PEGylated uricase.
Focus on Rare Renal Indications (Preclinical Programs)
- The Company is deepening its focus on rare renal diseases by advancing PRX–119, its long–acting DNase I program.
- The Company is also collaborating with Secarna to discover RNA–based therapeutic candidates that may complement its ProCellEx platform.
Financial Outlook: Building Durable Growth and Long–Term Value
Protalix enters 2026 with a profitable commercial business through its partnerships and a focused pipeline aligned to areas of high unmet need. The Company has a strong balance sheet, with no outstanding debt or warrants. The Company believes that its current business model limits downside risk while preserving significant upside potential as the Company progresses its clinical programs, expands its commercial footprint, and pursues strategic partnerships to accelerate impact and scale.
Priorities remain consistent:
- Support our commercial partnerships
- Advance PRX–115 as a potential best–in–class therapy for uncontrolled gout
- Advance rare renal programs leveraging the Company's R&D strengths
Based on current estimates, management expects:
- Total revenue in 2026 to range from approximately
$78.0 million $83.0 million $25.0 million - Full–year 2026 revenues from sales of Elfabrio without milestones to range from approximately
$33.0 million $35.0 million - Full–year 2026 revenues from sales of Elelyso to range from approximately
$20.0 million $23.0 million
- Full–year 2026 revenues from sales of Elfabrio without milestones to range from approximately
This outlook is not a guarantee of future performance, and stockholders should not rely on such forward-looking statements. These estimates are based on management's current estimates, which are subject to change and may be updated accordingly. See 'Forward-Looking Statements' for additional information.
Fiscal Year 2025 Financial Highlights
- Revenues from selling goods were
$51.8 million $1.2 million 2% ) versus$53.0 million $6.8 million $22.5 million $5.6 million $18.2 million Brazil ) (up$0.03 million $11.1 million
The decrease in revenues recorded from sales to Chiesi in 2025 resulted primarily from a change in the average net selling price of drug product in the applicable territory as well as changes in the quantities the Company sold to Chiesi's inventory. The increase in revenues recorded from sales to Pfizer resulted primarily from increased purchases of Elelyso by Pfizer to address unexpected manufacturing issues on their end. - Revenues from license and R&D services were
$0.9 million $0.5 million 125% ) from$0.4 million - Cost of goods sold were
$27.0 million $2.7 million 11% ) versus$24.3 million Brazil ) partially offset by a decrease in sales to Chiesi. - Research & development (R&D) expenses totaled
$19.6 million $13.0 million $6.6 million 51% ). The increase in research and development expenses resulted primarily from preparations for the RELEASE Phase 2 study of PRX-115. The Company expects to continue to incur significant and increasing research and development expenses as it progresses with the RELEASE study and commences more advanced stages of preclinical and clinical trials for certain of its other product candidates. - Selling, general and administrative (SG&A) expenses were
$11.7 million $0.5 million 4% ) from$12.2 million - Financial income (expenses), net was an expense of
$0.1 million $0.2 million $1.3 million $1.0 million - Taxes on income were
$1.0 million $0.2 million 18% ) compared to$1.2 million U.S. Internal Revenue Code Section 174 (theU.S. Tax Cuts and Jobs Act). - Cash, cash equivalents, and short–term bank deposits were
$30.3 million - Net loss for the year ended December 31, 2025, was approximately
$6.6 million $(0.08) $2.9 million $0.04
Conference Call and Webcast Information
The Company will host a conference call today, March 18, 2026, at 8:00 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date: March 18, 2026
Time: 8:00 a.m. Eastern Daylight Time (EDT)
Toll Free: 1-877-423-9813
International: 1-201-689-8573
Israeli Toll Free: 1-809-406-247
Conference ID: 13758983
Call me™: http://bit.ly/4aOQNnE
The Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away.
Webcast Details:
The conference will be webcast live from the Protalix website and will be available via the following links:
Company Link: https://ir.protalix.com/news-events/events
Webcast Link: https://tinyurl.com/4jxzchdh
Conference ID: 13758983
Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Protalix website, at the above link.
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed, and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix is the first company to gain
Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit www.protalix.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements generally relate to future events or the Company's future financial or operating performance, including the 2026 financial outlook described above. Actual outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements. The terms "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings of the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement, and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the projected market of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and/or inability to monitor patients adequately during or after treatment; the risk that the results of our clinical trials of our product candidates will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; the possible disruption of our operations due to the regional conflict in
Investor Contact
Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
PROTALIX BIOTHERAPEUTICS, INC. | ||||||
December 31, | ||||||
2024 | 2025 | |||||
ASSETS | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | $ | 19,760 | $ | 14,680 | ||
Short-term bank deposits | 15,070 | 15,593 | ||||
Restricted deposit | - | 702 | ||||
Accounts receivable | 2,909 | 8,840 | ||||
Other assets | 1,096 | 1,129 | ||||
Inventories | 21,243 | 25,729 | ||||
Total current assets | $ | 60,078 | $ | 66,673 | ||
NON-CURRENT ASSETS: | ||||||
Funds in respect of employee rights upon retirement | $ | 462 | $ | 578 | ||
Property and equipment, net | 4,591 | 4,879 | ||||
Deferred income tax asset | 2,856 | 2,516 | ||||
Operating lease right of use assets | 5,430 | 7,700 | ||||
Total assets | $ | 73,417 | $ | 82,346 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable and accruals: | ||||||
Trade | $ | 4,533 | $ | 5,259 | ||
Other | 19,588 | 19,875 | ||||
Operating lease liabilities | 1,500 | 1,384 | ||||
Total current liabilities | $ | 25,621 | $ | 26,518 | ||
LONG TERM LIABILITIES: | ||||||
Liability for employee rights upon retirement | $ | 559 | $ | 661 | ||
Operating lease liabilities | 4,026 | 6,937 | ||||
Total long term liabilities | $ | 4,585 | $ | 7,598 | ||
Total liabilities | $ | 30,206 | $ | 34,116 | ||
COMMITMENTS | ||||||
STOCKHOLDERS' EQUITY | ||||||
Common Stock, | 76 | 80 | ||||
Additional paid-in capital | 421,528 | 433,147 | ||||
Accumulated deficit | (378,393) | (384,997) | ||||
Total stockholders' equity | 43,211 | 48,230 | ||||
Total liabilities and stockholders' equity | $ | 73,417 | $ | 82,346 | ||
PROTALIX BIOTHERAPEUTICS, INC. | |||||||||
Year Ended December 31, | |||||||||
2023 | 2024 | 2025 | |||||||
REVENUES FROM SELLING GOODS | $ | 40,418 | $ | 52,981 | $ | 51,802 | |||
REVENUES FROM LICENSE AND R&D SERVICES | 25,076 | 418 | 942 | ||||||
TOTAL REVENUE | 65,494 | 53,399 | 52,744 | ||||||
COST OF GOODS SOLD | (22,982) | (24,319) | (26,993) | ||||||
RESEARCH AND DEVELOPMENT EXPENSES | (17,093) | (12,970) | (19,569) | ||||||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (14,959) | (12,193) | (11,682) | ||||||
OPERATING INCOME (LOSS) | 10,460 | 3,917 | (5,500) | ||||||
FINANCIAL EXPENSES | (3,180) | (1,062) | (1,191) | ||||||
FINANCIAL INCOME | 1,286 | 1,299 | 1,083 | ||||||
FINANCIAL INCOME (EXPENSES), NET | (1,894) | 237 | (108) | ||||||
INCOME (LOSS) BEFORE TAXES ON INCOME | 8,566 | 4,154 | (5,608) | ||||||
TAXES ON INCOME | (254) | (1,222) | (996) | ||||||
NET INCOME (LOSS) | $ | 8,312 | $ | 2,932 | $ | (6,604) | |||
EARNINGS (LOSS) PER SHARE OF COMMON STOCK: | |||||||||
BASIC | $ | 0.12 | $ | 0.04 | $ | (0.08) | |||
DILUTED | $ | 0.09 | $ | 0.04 | $ | (0.08) | |||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK | |||||||||
USED IN COMPUTING EARNINGS (LOSS) PER SHARE: | |||||||||
BASIC | 67,512,527 | 72,530,698 | 78,546,234 | ||||||
DILUTED | 82,424,016 | 81,057,176 | 78,546,234 | ||||||
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SOURCE Protalix BioTherapeutics, Inc.
FAQ
What did Protalix (PLX) announce about Elfabrio dosing in the EU on March 18, 2026?
How does the $25.0 million Chiesi milestone affect Protalix's cash outlook for April 2026?
What revenue guidance did Protalix (PLX) provide for full‑year 2026 on March 18, 2026?
What is the status and timeline for Protalix's PRX‑115 clinical program as of March 18, 2026?
How did Protalix's key financials change in fiscal 2025 compared to 2024?
