Protalix BioTherapeutics, Inc. (PLX) Market Cap
Protalix BioTherapeutics, Inc. has a market capitalization of $186.9M.
Financials based on reported quarter end 2025-12-31
Price: $2.32
▲ 0.02 (0.87%)
Market Cap: 186.93M
AMEX · time unavailable
CEO: Dror Bashan
Sector: Healthcare
Industry: Biotechnology
IPO Date: 1998-05-15
Website: https://www.protalix.com
Protalix BioTherapeutics, Inc. (PLX) - Company Information
Market Cap: 186.93M · Sector: Healthcare
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.
Analyst Sentiment
Based on 1 ratings
Consensus Price Target
No data available
Price & Moving Averages
Related Companies in Healthcare
OMNIAB INC (OABI)
Healthcare
$0.19B
Mkt Cap
CARTESIAN THERAPEUTICS INC (RNAC)
Healthcare
$0.19B
Mkt Cap
TONIX PHARMACEUTICALS HOLDING CORP (TNXP)
Healthcare
$0.19B
Mkt Cap
INOGEN INC (INGN)
Healthcare
$0.19B
Mkt Cap
TUHURA BIOSCIENCES INC (HURA)
Healthcare
$0.19B
Mkt Cap
SANARA MEDTECH INC (SMTI)
Healthcare
$0.19B
Mkt Cap
PLX’s Q4’25 call highlights a clear near-term financial catalyst: the European Commission approved Elfabrio (2 mg/kg) every 4 weeks for adults stable on enzyme replacement therapy, triggering a $25M Chiesi regulatory milestone and supporting a projected ~$50M cash balance by early April 2026. Management guided FY2026 total revenues of ~$78M–$83M (including the milestone), with Chiesi contributing ~$33M–$35M (>50% growth) and Elelyso ~$20M–$23M; they expect the revenue mix to shift toward Chiesi to strengthen margins. On pipeline execution, PRX-115 is actively enrolling in the RELEASE Phase II (first patients randomized), with top-line results expected in H2 2027; gout positioning is framed around a differentiated multi-arm regimen (including month-without-methotrexate and 4/6/8-week options). Key uncertainties remain in partner-driven quarterly variability, EU country-by-country rollout timing, and U.S. dosing approval timing; clinical and commercial differentiation for PRX-115 is still outcome-dependent.
Growth Catalysts
- Elfabrio EU approval: 2 mg/kg every 4 weeks regimen for adults stable on enzyme replacement therapy (E.U.); expected to enhance competitive positioning and reduce patient treatment burden
- Pipeline: PRX-115 Phase II RELEASE study enrollment underway; first patients randomized; top-line results anticipated in H2 2027
- Pipeline expansion: PRX-119 (long-acting DNase) advancing; rare renal pipeline also includes RNA-based collaboration with Secarna
Business Development
- Partner Chiesi: EU 4-week dosing approval execution credited to Chiesi; $25 million regulatory milestone payment triggered
- Partner Chiesi revenue: consistent increasing patient numbers across U.S. and key ex-U.S. markets
- Partner Pfizer: increased purchases of Elelyso to address unexpected manufacturing issues
- Fiocruz: sales volume referenced in COGS drivers
Financial Highlights
- FY2025 revenues from selling goods: $51.8M, modest decrease vs 2024 (driven by quantity changes to Chiesi inventory and average net selling price changes tied to increased commercial patients in Europe)
- FY2025 R&D expense: $19.6M, up 51% YoY (driven mainly by spending on PRX-115 RELEASE study)
- FY2025 net loss: $6.6M vs net income of $2.9M in 2024 (loss attributed to increased investment in clinical pipeline)
- COGS: $27.0M (higher due to sales volume to Pfizer and Fiocruz, partially offset by lower sales to Chiesi)
- SG&A: $11.7M, declined slightly (lower share-based compensation)
- Income tax expense: $1.0M (related to U.S. tax rules for GILTI)
- Guidance FY2026 total revenue: $78M–$83M including $25M milestone; Chiesi revenues: $33M–$35M representing growth of >50%; Elelyso revenues: $20M–$23M
- Cash: $30.3M held at 12/31/2025; milestone expected to support projected cash balance of ~$50M by early April 2026
Capital Funding
- Regulatory milestone: $25M from Chiesi upon EU approval of Elfabrio 4-week regimen
- Projected cash runway: cash balance of approximately $50M by early April 2026
- No buyback amount disclosed; no new debt issued discussed in provided transcript
- Secured convertible notes: fully repaid in 2024 (cited as reducing interest expense)
Strategy & Ops
- Revenue mix strategy: expect shift toward Chiesi over time to improve margin profile (Chiesi described as high-margin long-term revenue)
- Clinical operations: PRX-115 RELEASE Phase II enrolling; 5-arm design with placebo; arms include monthly dosing without methotrexate and methotrexate-containing arms dosed once every 4/6/8 weeks
- Commercial execution: Chiesi increasing patient numbers via promotions in the U.S. and support activities (Europe noted as having restrictions on certain patient promotion practices compared with U.S.)
Market Outlook
- 2026 total revenue guidance: ~$78M–$83M (includes $25M Chiesi milestone)
- 2026 Chiesi revenue guidance: ~$33M–$35M (>50% growth)
- 2026 Elelyso revenue guidance: ~$20M–$23M
- EU rollout impact timing: expected effect to start in 2H 2026 and more meaningfully in 2027+ (approval received 5 March; country-by-country assessment by Chiesi)
- Investor update cadence: management plans to update within ~2 months on outcomes of Q1 2026
Risks & Headwinds
- Quarter-to-quarter revenue variability risk: revenues from partners may fluctuate based on partners’ inventory management and purchasing patterns (annual trends emphasized)
- Regulatory/reimbursement rollout uncertainty in Europe: depends on country-by-country approvals and reimbursement/logistics processes
- U.S. timing uncertainty for 4-week dosing approval: management stated it is too early to comment on when U.S. approval may occur
- Clinical execution risk: PRX-115 Phase II outcomes not yet known; differentiation (efficacy/safety/immunogenicity) depends on end-of-Phase II results
- Supply/manufacturing disruption risk: Pfizer purchases increased due to unexpected manufacturing issues—future purchasing could vary with manufacturing stability
Sentiment: MIXED
Note: This summary was synthesized by AI from the PLX Q4 2025 earnings transcript. Financial data is complex; please verify all metrics against official SEC filings before making investment decisions.
Fundamentals Overview
📊 AI Financial Analysis
Powered by StockMarketInfo"PLX reported a revenue of $9.12M, showing modest growth amid challenges. The company recorded a net income loss of $5.50M, resulting in an EPS of -$0.0649. Operating cash flow stood at $2.03M, while free cash flow was $3.27M, indicating operational efficiency despite profitability issues. Balance sheet strength is noted with total assets of $82.35M and total equity of $48.23M. The company maintains a net debt position of -$6.36M, suggesting a favorable cash position. However, shareholder returns suffer due to a lack of dividends and a significant 1-year price decline of 20.38%. Improvements in market performance, evidenced by a 6-month increase of 5.61% and a year-to-date gain of 18.97%, show recovery potential but remain insufficient for a positive return overall. This combination of revenue generation and operational cash flow is promising, yet consistent losses may hinder future growth prospects."
Revenue Growth
Minimal revenue growth observed at $9.12M.
Profitability
Negative net income and EPS indicate significant challenges.
Cash Flow Quality
Positive operating and free cash flow reflects operational efficiency.
Leverage & Balance Sheet
Strong balance sheet with net debt position showing asset strength.
Shareholder Returns
Significant price decline overshadows potential recovery; no dividends.
Analyst Sentiment & Valuation
Mixed sentiments due to recovery signs amidst profitability issues.
Disclaimer:This analysis is AI-generated for informational purposes only. Accuracy is not guaranteed and this does not constitute financial advice.