Analyst Conference Summary

Biotechnology

conference date: November 14, 2024 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2024 (Q3, third quarter 2024)

Forward-looking statements

Overview: Sold enough product to make a profit in the quarter.

Basic data (GAAP):

Revenue was $17.8 million, up 37% sequentially from $13.3 million, and up 75% from $10.2 million year-earlier.

Net income was $3.2 million, up sequentially from negative $2.2 million, and up from negative $1.9 million year-earlier.

EPS (diluted) was $0.03, up sequentially from negative $0.03, and up from negative $0.04 year-earlier.

Guidance:

none

Conference Highlights:

Dror Bashan, Protalix's CEO, said "We are pleased to report that all eight cohorts of our phase I first-in-human study of PRX-115, our recombinant uricase candidate being developed for the treatment of uncontrolled gout, are now complete. All eight cohorts from the Phase 1 demonstrate the potential of PRX-115 to be a dose-dependent uric-acid lowering treatment option for individuals with gout. Adverse events were mainly mild to moderate. We are actively planning a Phase II clinical trial of PRX-115 in gout patients and expect to initiate the study in the second half of 2025."

Paid off $20 million of convertible notes in September 2024.

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.

Revenue from sales was $17.8 million, up 75% from $10.2 year-earlier. Taliglucerase alfa revenue was up $1.1 million y/y; Elfabrio sales to Chiesi up $6.8 million y/y; decrease of $0.3 million in sales to Brazil. Revenue from license and R&D services was $0.1 million

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 in Q3 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 $27.4 million, down sequentially from $45 million, but paid off $20 million in convertible notes.

Cost of goods sold was $8.4 million. R&D (net of grants) expense $3 million. SG&A $2.6 million. Leaving an operating income of $4.0 million. Tax $0.6 million. Financial expenses net $0.2 million.

Q&A selective summary:

Chiesi revenues nature? All product revenue. We sell into their inventory.

Chiesi study on less frequent dosing? Is in discussion with authorities.

Elfabrio in US? We showed we are as good as Fabryzym. Allows patients a good alternative.

Competition in gout? In discussion with agencies about plan for Phase 2. If results are same as Phase 1 we have a very interesting potential drug.

We are not discussing allowing other companies to use our technology. We believe developing our own drugs is better for shareholders than becoming a CMO.

Anaphylactic episode? Was 6 minutes into infusion, he recovered, was just 1 patient of 64.

Duration of Phase 2 trial? 12 month duration. Start in 2H 2025, depends on pace of enrollment.

Japan Elfabrio study is ongoing, Japan is a unique market.

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