Protalix Biotherapeutics Inc (NYSE-A:PLX) reported increased product revenues for 2024, driven by higher sales of its Fabry disease treatment, Elfabrio, to partner Chiesi Rare Disease.
The company’s improving financial position and revenue outlook have analysts projecting further upside following the release of its full year 2024 results.
Zacks Small Cap Research cited its debt-free balance sheet, expected free cash flow generation, and growth potential from its two approved therapies.
“One of the primary risks in the small-cap space is absent for Protalix, which is the need to raise capital and dilute earlier investors,” analysts wrote, noting that this could shift investor interest toward long-only holders.
Commercialized therapies
The Israel-based biopharmaceutical company has commercialized two enzyme replacement therapies: Elelyso, approved in 2012 for Gaucher disease, and Elfabrio, which received FDA and European Medicines Agency (EMA) approval in May 2023 for Fabry disease. Elfabrio, developed in partnership with Chiesi, has since secured approvals in multiple markets, including the US, EU, Great Britain, Israel, and Singapore.
Protalix’s therapies are manufactured using its proprietary ProCellEx platform, which employs plant cell expression rather than the mammalian cell systems commonly used in biologic drug production.
Competitve positioning
Analysts see Elfabrio’s competitive positioning as a key driver of future revenue growth.
The global Fabry disease market, estimated at $2 billion, is currently dominated by Fabrazyme, Replagal, and Galafold. However, Zacks sees a strong opportunity for Elfabrio to gain market share due to limitations with existing treatments.
“Many patients develop antibodies against the enzyme in Fabrazyme and Replagal which reduces its effectiveness,” analysts wrote, adding that Galafold “is only appropriate for a subset of Fabry patients that have a certain galactosidase alpha gene (GLA) mutation.”
Protalix’s commercial partner Chiesi has submitted a Variation Application to the EMA seeking approval for a four-week dosing regimen for Elfabrio, compared to the current two-week schedule required for Fabrazyme and Replagal. “If Elfabrio were able to gain approval for administration every four weeks, this could reduce the number of administrations relative to these older medicines by half to 13 infusions per year,” Zacks wrote.
Beyond its commercial portfolio, Protalix is advancing PRX-115, a recombinant uricase for gout, with a Phase II trial set to begin in late 2025. The company is also enrolling patients in pediatric and Japanese studies for Elfabrio, with readouts expected in 2025.
With more than $27 million in cash and no outstanding debt, Protalix anticipates generating positive free cash flow in the coming year.
Zacks maintains a valuation of $14 per share for Protalix. Shares were trading around $2.38 on Tuesday afternoon.