Analyst Conference Summary

Biotechnology

conference date: May 10, 2024 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2024 (Q1, first quarter 2024)

Forward-looking statements

Overview: Revenue from selling therapies remains minimal.

Basic data (GAAP):

Revenue was $3.7 million, down sequentially from $na million, and down % from $9.6 million year-earlier.

Net income was negative $4.6 million, down sequentially from negative $na million, and down from negative $3.1 million year-earlier.

EPS (diluted) was negative $0.06, down sequentially from negative $na, and down from negative $0.05 year-earlier.

Guidance:

Has cash runway, sees Elfabrio revenue gradually ramping.

Conference Highlights:

Dror Bashan, Protalix's CEO, said "We are pleased to announce that initial top-line results from the first seven cohorts of the first-in-human phase I clinical trial of our recombinant uricase candidate, PRX-115, are encouraging, enabling us to expand into an eighth cohort and to begin planning a phase II trial. We will analyze and announce the full results from the expanded trial following the completion of the new cohort. We believe that our strong cash position is sufficient to enable the repayment of our convertible notes due September 2024, and for our ongoing operations."

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 (PRX-102, pegunigalsidase alfa) for the treatment of adult patients with Fabry disease. On August 15 Chiesi announced the UK granted marketing authorization. On September 11, 2023 Switzerland granted approval. Chiesi has launches underway in the US, EU, and other nations. Expects Elfabrio revenue to continue to ramp. The Fabry market is about $2 billion. There is competition for it.

Revenue from sales was $3.7 million. Taliglucerase alfa revenue was $ million, down y/y on lower sles to Pfizer; and $0 in sales of Elfabrio to Chiesi. Revenue from license and R&D services was $0 million

In Q1 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, was fully enrolled. Top line results are positive. 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. Another cohort is being added to the Phase 1 trial. A Phase 2 trial is being planned.

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

Cash and equivalents balance ended at $48 million, up sequentially from $44.6 million. Debt is $20.4 million in convertible notes due in 2024.

Cost of goods sold was $2.6 million. R&D (net of grants) expense $2.9 million. SG&A $3.1 million. Leaving an operating income of negative $4.9 million. Tax benefit $0.1 million. Financial income $0.1 million.

Q&A selective summary:

PRX-115, subpopulation aimed at, competition? The Phase 1 is a single dose study. Addresses uncontrolled gout patients. Phase 2 study will have multiple doses. We hope to see improved safety and better frequency than currently approved therapies. Uric acid way below six. Results so far are encouraging. Intent is to compete for uncontrolled gout patients.

PRX-115 PK levels over the 3 month observation period? Not releasing full data yet. Uric acid has been reduced fast and significantly. Observation over 3 months does not mean we plan to dose every three months.

The one anaphlactic reaction was quickly and easily resolved. Was in the second of 7 cohorts.

We plan to be debt free by year end. We will have cash to continue research. We are confident Chiesi will ramp up sales and allow us to support R&D over time.

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