Analyst Conference Summary

Biotechnology

conference date: March 14, 2024 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2023 (Q4, fourth quarter 2023)

Forward-looking statements

Overview: Reported $8.3 million in net income, or $0.09 per share, for the full year 2023.

Basic data (GAAP):

For the Q4 call and press release gave full year 2023 data, did not separate out Q4 data.

Revenue was $ million, down sequentially from $10.3 million, and down % from $ million year-earlier.

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

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

Guidance:

Has cash runway, sees Elfabrio revenue gradually ramping.

Conference Highlights:

Dror Bashan, Protalix's CEO, said "2023 was a significant year for Protalix, as we received regulatory approvals of Elfabrio for the treatment of adult patients with Fabry disease and advanced our growing pipeline. As the second drug produced through our proven protein expression platform, Elfabrio's approval is a welcome milestone for Fabry disease patients and their families. Our commercial partner Chiesi Global Rare Diseases is continuing to position Elfabrio for global success, with launches underway in the United States, the European Union, the UK and additional markets where approvals were granted. As we continue to provide Chiesi with operational support for its activities, we have turned our attention to developing our innovative pipeline. For example, PRX-115, our proprietary recombinant PEGylated uricase for the treatment of severe gout, is currently being studied in a first-in-human phase I clinical trial. We anticipate that results from the trial will be published in the second quarter of 2024." Elfabrio also approved in Israel.

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.

The Fabry market is about $2 billion. There is competition for it.

Revenue from sales was $ million. Taliglucerase alfa revenue was $ million, down y/y on lower sles to Pfizer; and $ in sales of Elfabrio to Chiesi. Revenue from license and R&D services was $ 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 expected in mid-2024. 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.

PRX-119 still in preclinical work on ? related diseases.

Cash and equivalents balance ended at $44.6 million, up sequentially from $41 million. Debt is $28.2 million in convertible notes due in 2024.

Cost of goods sold was $ million. R&D (net of grants) expense $ million. SG&A $ million. Leaving an operating income of negative $ million. Taxes $ million. Financial income $ million.

Full year 2023 revenue was 65.5 million.

Q&A selective summary:

PRX-102 Japan and pediatric trials? Conducted by Chiesi. Does not have a timeline.

Revenue and expense in 2024? Free cash flow depends on how much we spend on R&D. Expects for sales to ramp, will eventually get to better cash flow.

PRX-115 timeline? If positive results, next step is Phase 2. Should start by first half of 2025.

PRX-119 timeline? We are still looking for the best indication to pursue, so no timeline for entering the clinic yet.

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