Analyst Conference Summary

Biotechnology

conference date: August 14, 2024 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2024 (Q2, second quarter 2024)

Forward-looking statements

Overview: Slow armp of Elfabrio so far.

Basic data (GAAP):

Revenue was $13.3 million, up 259% sequentially from $3.7 million, but down 68% from $35.1 million year-earlier.

Net income was negative $2.2 million, up sequentially from negative $4.6 million, and down from $19.3 million year-earlier.

EPS (diluted) was negative $0.03, up sequentially from negative $0.06, and down from $0.21 year-earlier.

Guidance:

none

Conference Highlights:

Dror Bashan, Protalix's CEO, said "In the second quarter, Protalix has made meaningful progress on our early-stage pipeline," said Dror Bashan, Protalix's President and Chief Executive Officer. "Results from the first seven cohorts of the phase I clinical trial of PRX-115 for the treatment of uncontrolled gout are encouraging, and we anticipate topline results from all eight cohorts to be available in the third quarter of 2024. Based on the safety results to date, we have initiated preparations for a phase II clinical trial of PRX-115 in uncontrolled gout patients. Our strong balance sheet enables repayment of our convertible notes due September 2024 while maintaining ongoing operations and executing on our corporate strategy." Revenue was down from Q2 2023 because of 2023 initial stocking of Elfabrio plus $20 million milestone. Plans to pay off convertible notes next month.

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 $13.3 million, down 12% from $15.1 year-earlier. Taliglucerase alfa revenue was $na million, up $3.5 million y/y on higher sales to Pfizer and $4.7 million on sales to Brazil; and $0 in sales of Elfabrio to Chiesi. Revenue from license and R&D services was $0.2 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 will be 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 $45 million, down sequentially from $48 million. Debt is $20.4 million in convertible notes due in 2024.

Cost of goods sold was $9.5 million. R&D (net of grants) expense $3 million. SG&A $3.5 million. Leaving an operating income of negative $2.4 million. Tax benefit $0.1 million. Financial income $0.5 million. Financial expense $0.4 million.

Q&A selective summary:

Elfabrio uptake, payer responses? Chiesi is not giving us that level of detail. We are pleased with the launch so far.

Estimated Elfabrio sales to Chiesi? They order in batches, hard to predict timing, but will take a while. Cautiously optimistic. We do meet with them for updates, relationship is good.

115 v. competition? Hopefully Phase 2 will mimic what we are seeing in Phase 1. It should be an alternative to both enzymes.

Anti-TNF? We closed that program. We are evaluating about a dozen preclinical programs.

Note repayment? Pay the notes by September 1. No plans to take new debt. We have resources to maintain operations including the Phase 2 trial.

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