On Monday, Protalix BioTherapeutics, Inc. (NASDAQ:PLX) reported fiscal 2024 earnings of 4 cents, beating the consensus of 1 cent.

The company recorded 2024 sales of $53.40 million, up 31% year over year, slightly below the consensus of $53.94 million.

The increase resulted primarily from an increase of $11.8 million in sales to Chiesi, an increase of $0.6 million in sales to Brazil, and an increase of $0.1 million in sales to Pfizer.

Protalix is a biopharmaceutical company focused on developing and commercializing recombinant therapeutic proteins expressed through its plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration approval of a protein produced through plant cell-based in suspension expression system.

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Protalix has licensed to Pfizer Inc (NYSE:PFE) the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix’s first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. The FDA and the European Medicines Agency approved Protalix’s second product, Elfabrio, in May 2023.

“2024 was a record year in revenues from selling goods for Protalix, as we experienced increases in all three of our revenue streams, Chiesi, Pfizer, and Brazil,” said Dror Bashan, Protalix’s president and CEO.

“We are pleased with the promising results from our first-in-human study of our gout candidate, PRX-115, in adult volunteers with elevated uric acid levels, and hope to build on this momentum with the goal of initiating a phase II clinical trial in patients with gout during the second half of 2025,” Bashan said. “At the same time, we continued to evaluate additional pipeline candidates, including PRX-119, for potential further development.”

In September 2024, the company repaid its 7.50% Senior Secured Convertible Promissory Notes. The repayment of the convertible notes at maturity was financed entirely with available cash.

“Now that our debt is fully repaid and we no longer have outstanding warrants, our balance sheet is stronger and we are well-positioned to continue executing on our strategy through 2025 and beyond,” Bashan added.

In December, Chiesi and Protalix BioTherapeutics announced that the European Medicines Agency validated the Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease. The currently approved dose of pegunigalsidase alfa is 1 mg/kg administered every two weeks.

Price Action: PLX stock is up 17.4% at $2.630 at the last check Monday.

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