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What were the key takeaways from Protalix’s earnings call?

- **Revenue Growth**: Year-to-date 2025 revenue up 24% to $43.6 million, despite Q3 2025 dip (-1% YoY).
- **Pipeline Momentum**: PRX-115 Phase II trial set to begin in Q4 2025; CHMP reexamination decision expected Q1 2026.
- **Financial Strength**: $29.4 million cash balance, 12-month runway, and 33% YoY net income growth.
- **Strategic Focus**: Balancing R&D investment (58% YoY R&D spend increase) with disciplined commercial execution.

**【CEO Summary Section】**
- **Revenue Performance**: Year-to-date 2025 total revenues reached $43.6 million (+24% YoY), driven by Elfabrio sales to Chiesi, Pfizer, and Fiocruz. Q3 2025 revenue was $17.9 million (-1% YoY) due to partner inventory management variability.
- **Pipeline Progress**: PRX-115 Phase II trial for uncontrolled gout is set to begin in Q4 2025, following FDA IND approval. The company believes PRX-115 could be a best-in-class uricase therapy with a long-acting profile.
- **Regulatory Update**: Chiesi requested reexamination of the CHMP's negative opinion on Elfabrio's 4-week dosing regimen; a decision is expected in Q1 2026. The currently approved 2-week regimen remains unaffected.
- **Financial Position**: Strong cash balance of $29.4 million as of Q3 2025, supporting R&D investments (e.g., PRX-115 Phase II) and commercial operations.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: Q3 2025 sales to Chiesi ($8.8M), Pfizer ($2.8M), and Fiocruz ($6.1M). Year-to-date R&D expenses rose 58% to $13.9 million, driven by PRX-115 preparations.
- **Profitability**: Q3 2025 net income of $2.4 million (+33% YoY), with a 12-month cash runway.
- **Cost Management**: SG&A decreased 11% YoY to $8.2 million, reflecting reduced selling expenses.

**【Q&A Key Highlights】**
- **CHMP Timeline**: Reexamination decision expected Q1 2026; no new trials planned unless needed post-reexamination.
- **PRX-115 Trial**: Phase II initiation in Q4 2025, with top-line results anticipated in Q3 2027.
- **Revenue Visibility**: Gilad Mamlok emphasized predictable royalty streams from Elfabrio, though quarterly fluctuations may occur due to partner inventory timing.
- **Pipeline Expansion**: PRX-119 in early development, with updates pending preclinical results.
- **Global Expansion**: Chiesi pursuing new Elfabrio approvals in additional markets, though no new approvals disclosed since last update.

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

- **Revenue Growth**: 50% H1 2025 increase driven by $8M Elfabrio sales to Chiesi.
- **Elfabrio Potential**: $100M+ annual royalties by 2030 in $3.2B Fabry market.
- **PRX-115 Trial**: Phase II to begin Q4 2025 with 20-30 U.S. sites.
- **Financial Health**: $33.4M cash, break-even net income, 100% R&D spending increase.
- **Leadership Transition**: Eyal Rubin departing after 6 years, Gilad Mamlok to lead finance.

**【CEO Summary Section】**
- First half 2025 revenue increased 50% YoY, driven by $8M sales growth to Chiesi for Elfabrio.
- Elfabrio targeting $3.2B global Fabry market (2030), with 15-20% market share expected to generate >$100M annual royalties by 2030.
- Phase II trial for PRX-115 gout candidate to begin Q4 2025, with 20-30 trial sites primarily in the U.S.
- CFO transition: Eyal Rubin stepping down after 6 years, succeeded by Gilad Mamlok, a seasoned healthcare finance executive.

**【CFO Financial Commentary】**
- Q2 2025 revenue: $15.4M (16% YoY growth), with $13.3M from goods sales and $0.2M from licensing/R&D services.
- Cost of goods sold decreased 38% to $5.9M due to reduced Pfizer sales.
- R&D expenses doubled to $6M (100% YoY growth) to support PRX-115 Phase II trial.
- Cash reserves: $33.4M as of June 30, 2025.
- Net income: $164,000 (break-even) vs. $2.2M loss YoY, driven by lower financial expenses.

**【Q&A Highlights】**
- Chiesi's Elfabrio Phase IV PEGASO trial aims to validate real-world effectiveness and safety, with results expected to strengthen market positioning.
- PRX-115 Phase II trial will enroll first patient Q4 2025, with 20-30 U.S. sites and a few international sites.
- Management reaffirmed focus on organic growth through pipeline development, with no immediate plans for M&A or licensing deals.
- Chiesi's commercial execution exceeding expectations, with accelerating patient acquisition and market share growth despite inventory fluctuations.


Protalix BioTherapeutics, Inc. (PLX) Q2 2025 Earnings Call Transcript

- **Revenue surge**: Q1 2025 goods sales jump 170% YoY to $10M, fueled by Pfizer and Brazil partnerships.
- **PRX-115 momentum**: Phase 2 gout trial set for H2 2025 after promising Phase 1 results showing long-acting uric acid reduction.
- **Elfabrio regulatory progress**: Chiesi's 4-week dosing application under review by EMA; potential $75M+ regulatory milestones remain.
- **Financial strength**: $34.7M cash balance supports pipeline expansion despite $3.6M net loss.

**【CEO Business Update】**
- Q1 2025 revenue from goods sold increased 170% YoY to $10 million, driven by sales to Pfizer and Fiocruz Brazil.
- PRX-115 Phase 1 trial showed rapid uric acid reduction and long-acting effect; Phase 2 trial in gout expected to begin H2 2025.
- Elfabrio partner Chiesi submitted EMA application to reduce dosing frequency to every 4 weeks; EMA review expected Q4 2025.
- R&D pipeline expanded with PRX-119 (NETs therapy) and new renal rare disease programs.

**【CFO Financial Highlights】**
- COGS increased 215% YoY to $8.2M due to higher sales volumes.
- R&D expenses rose 21% YoY to $3.5M, driven by clinical pipeline advancement.
- SG&A decreased 16% YoY to $2.6M from cost optimization.
- Net loss narrowed to $3.6M (Q1 2024: $4.6M) with $34.7M cash on hand.

**【Key Q&A Takeaways】**
- Chiesi Elfabrio sales pace "beyond expectations" but confidential due to private company status.
- No U.S. dosing frequency application filed yet; focus on EMA approval first.
- PRX-115 Phase 2 trial will enroll majority of patients in U.S.
- Up to $75M potential regulatory milestones remain under Chiesi agreement.

Protalix BioTherapeutics (PLX)-9 May 25-2025 Q1 Earnings call transcript

- **Record Revenue & Financial Strength**: $53M FY2024 revenue (+31%), $34.8M cash, and debt-free balance sheet enable strategic R&D.
- **Pipeline Momentum**: PRX-115 Phase 2 ($20M budget) set for H2 2025; PRX-119 indication selection underway with 2030 market sizing.
- **Elfabrio Growth**: Chiesi expanding commercial reach; $100M+ royalty potential by 2030 with every 4-week dosing label.
- **Cost Efficiency**: 24% R&D expense reduction, 19% SG&A decline, and $2.1M from warrant exercises support operational flexibility.


**【CEO Key Updates】**
- **Revenue Growth & Debt Repayment**: FY2024 revenue reached $53M (+31% YoY), driven by sales to Chiesi. Fully repaid $7.5M convertible notes in Q3 2024, strengthening balance sheet.
- **PRX-115 Progress**: Completed Phase 1 trial for uricase candidate, showing safety and efficacy. Targeting Phase 2 initiation in H2 2025 with $20M external costs, seeking partner post-positive results.
- **Elfabrio Collaboration**: Chiesi expanding commercial efforts; EMA validated label expansion for every 4-week dosing. Projected $100M+ royalty revenue by 2030.
- **PRX-119 Development**: Long-acting DNase I candidate for NET-related diseases. Finalizing indication selection; potential market size to be disclosed in Q2 2025.

**【CFO Financial Highlights】**
- **Topline Performance**: Goods sales $53M (+31%), offsetting 98% decline in license/R&D revenue ($0.4M vs $25.1M). FY2024 net income $2.9M ($0.04/share), down 65% YoY due to one-time tax expenses.
- **Cost Management**: R&D expenses $13M (-24%), SG&A $12.2M (-19%), reflecting clinical program completion and reduced professional fees.
- **Liquidity**: $34.8M cash at year-end, supporting Phase 2 trials and R&D without external financing.

**【Q&A Key Takeaways】**
- **Elfabrio Royalty Outlook**: Chiesi adding patients weekly; royalty stream expected to stabilize in 1.5-2 years. No 2025 guidance due to inventory sales model.
- **PRX-119 Differentiation**: Long-acting vs acute PRX-110; targeting NET-related indications with potential >$1B market opportunity.
- **PRX-115 Mechanism**: PEGylated uricase reduces uric acid levels; Phase 2 targeting gout patients with uncontrolled hyperuricemia.


Protalix BioTherapeutics, Inc. (PLX) Q4 2024 Earnings Call Transcript

Protalix BioTherapeutics (PLX)-14 Nov 24-2024 Q3 Earnings call transcript

Protalix BioTherapeutics (PLX)-14 Aug 24-2024 Q2 Earnings call transcript

Protalix BioTherapeutics (PLX)-10 May 24-2024 Q1 Earnings call transcript

Protalix BioTherapeutics (PLX)-6 Nov 23-2023 Q3 Earnings call transcript

- **$20M Milestone Payment**: Received from Chiesi for Elfabrio approvals.
- **Revenue Surge**: Q2 2023 total revenue $35.5M (+308% YoY).
- **Pipeline Momentum**: 16 patients dosed in PRX-115 trial; PRX-119 preclinical.
- **Gross Margin Outlook**: ~85-90% for biological drugs.

**【CEO Summary Section】**
- **Elfabrio Milestone Achievement**: Received $20 million milestone payment from Chiesi following FDA and EMA approvals for Elfabrio, a treatment for adult patients with Fabry disease.
- **Pipeline Progress**: 
  - PRX-115 (PEGylated uricase) in Phase 1 trial with 16 patients dosed; enrollment expected to complete by end-2023.
  - PRX-119 (PEGylated DNase I) in preclinical stages for NETs-related diseases.
- **Strategic Focus**: Emphasized rare disease therapeutics and ProCellEx platform capabilities.

**【CFO Financial Commentary】**
- **Revenue Growth**: Q2 2023 total revenue $35.5 million (vs. $8.8 million in Q2 2022), driven by:
  - $15.1 million product sales (Elfabrio) + $20 million licensing fees.
- **Cost Management**: 
  - COGS $6.1 million (49% YoY increase).
  - R&D expenses $4.5 million (down 38% YoY).
  - SG&A $4 million (54% YoY increase).
- **Liquidity**: $48.2 million cash as of June 30, 2023.

**【Q&A Highlights】**
- **Elfabrio Commercialization**: Chiesi responsible for global launch and inventory build; U.S. launch underway, Europe approvals pending.
- **PRX-115 Trial**: Focus on safety, PK, and immunogenicity in gout patients; data expected Q2 2024.
- **Gross Margin Expectation**: Biological drug gross margins ~85-90% (industry standard).

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