Analyst Conference Summary

Biotechnology

conference date: March 17, 2025 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2024 (Q4, fourth quarter 2024)

Forward-looking statements

Overview: Profitable for full year 2024.

Basic data (GAAP):

Did not report Q4 data separately. Full year 2024 Revenue was $53.4 million, down 18% from $65.5 million in 2023.

2024 Net income was $3 million, down 62% from $8 million year-earlier.

2024 EPS (diluted) was $0.04, down 56% sequentially from $0.09 in 2023.

(Calculated) Q4 Revenue was $18.6 million, up 4% sequentially from $17.8 million, and up % from $na million year-earlier.

Q4 Net income was $6.6 million, 106% up sequentially from $3.2 million, and up from negative $na million year-earlier.

Q4 EPS (diluted) was $0.10, up 233% sequentially from $0.03, and up from negative $na year-earlier.

Guidance:

none

Conference Highlights:

Dror Bashan, Protalix's CEO, said "2024 was a record year in revenues from selling goods for Protalix, as we experienced increases in all three of our revenue streams, Chiesi, Pfizer and Brazil. We are pleased with the promising results from our first-in-human study of our gout candidate, PRX-115, in adult volunteers with elevated uric acid levels, and hope to build on this momentum with the goal of initiating a phase II clinical trial in patients with gout during the second half of 2025. At the same time, we continued to evaluate additional pipeline candidates, including PRX-119, for potential further development. Now that our debt is fully repaid and we no longer have outstanding warrants, our balance sheet is stronger and we are well-positioned to continue executing on our strategy through 2025 and beyond." Record revenues from partners in 2024. Revenue from sales went up 32% y/y, while revenue from license and R&D services dropped to negligible.

Paid off $20 million of convertible notes in September 2024. Since December 31, 2024, Protalix issued 908,000 shares of common stock in connection with the exercise of warrants issued in 2020 generating proceeds equal to approximately $2.1 million from such exercises. The warrants expired on March 11, 2025. Accordingly, no warrants remain outstanding.

On May 10, 2023 the FDA approved Elfabrio (pegunigalsidase alfa) for Fabry disease, with Chiesi. On May 5, 2023, with partner Chiesi Global Rare Diseases, the EMA approved Elfabrio. Expects Elfabrio revenue to continue to ramp. The Fabry market is about $2 billion. There is competition for it.

In May 2024, Protalix announced that the Phase I clinical trial of PRX–115, a recombinant PEGylated uricase product candidate under development as a potential treatment for severe gout, results were positive for the first seven dosing cohorts. The FIH trial is a double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX–115 in approximately 56 patients with elevated uric acid levels (>6.0 mg/dL) and no previous exposure to PEGylated uricase. Data including an eighth cohort was released at ACR November 2024. A Phase 2 trial is being planned to commence mid-2025.

PRX-119 still in preclinical work on NETs-related diseases. Has shown potential to be effective. Also building a broader preclinical pipeline, prioritizing rare renal diseases.

Cash and equivalents balance ended at $34.8 million, up sequentially from $27.4 million.

For full year 2024 cost of goods sold was $24 million. R&D (net of grants) expense $13 million. SG&A $12 million. Leaving an operating income of $4 million. Tax $1.2 million. Financial income net $0.2 million.

Q&A selective summary:

Longer run revenue guidance? We cannot give estimated revenue from Chiesi. We do know that every week they add Elfabrio patients. In 2030 we estimate over $100 million revenue from Ciesi. But we sell to Chiesi inventory, so can vary by quarter. No guidance for 2025. We are please with Chiesi sales.

PRX-119 v. PRX-110, and size of market? 119 is longer acting. Finalizing the indication selection for Phase 1. Within 2 quarters should have an update.

Cost of Phase 2, timeline for PRX-115? We plan to finance Phase 2 ourselves. Cost north of $30 million for external, plus our internal costs. Results in perhaps 2 years, assuming first patient in 2H 2025. If Phase 2 successful it would make sense to look for a commercial partner.

Elfabrio revenue in Q4? See 10-K [But I don't think it is there, it would be on a 10-Q.

PRX-115 mechanism of action? Uricase enzyme, we see uric acid reduction both quickly and over time. When we try it on severe gout we can update on how it works for that.

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