PROTALIX BIOTHERAPEUTICS, INC. (PLX)

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Protalix BioTherapeutics Announces $20 Million Milestone Payment from Chiesi Global Rare Diseases
https://finance.yahoo.com/news/protalix-biotherapeutics-announces-20-million-105000631.html

Milestone payment triggered by FDA approval of ELFABRIO® (pegunigalsidase alfa-iwxj) and payable within 30 days of approval

CARMIEL, Israel, May 18, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that it is eligible to receive a $20 million milestone payment from its commercial partner, Chiesi Global Rare Diseases, a business unit of the Chiesi Group. The milestone payment was triggered by the approval by the U.S. Food and Drug Administration (FDA) of ELFABRIO (pegunigalsidase alfa-iwxj) for the treatment of adult patients with Fabry disease, which was announced on May 10, 2023, and is payable within 30 days of the FDA approval date.

"Receiving this milestone payment resulting from the FDA's approval of ELFABRIO is an important step for Protalix as it further to strengthens our financial position," said Dror Bashan, Protalix's President and Chief Executive Officer. "We continue to be grateful to our commercial partner, Chiesi, who has the global expertise to maximize the market potential of pegunigalsidase alfa."

On July 23, 2018, the Company's wholly-owned subsidiary entered into an Exclusive License and Supply Agreement with Chiesi Farmaceutici S.p.A., or Chiesi (the Chiesi US Agreement), pursuant to which the Company granted Chiesi an exclusive license to commercialize pegunigalsidase alfa in the United States. This followed the Exclusive License and Supply Agreement entered into with Chiesi on October 19, 2017 (the Chiesi Ex-US Agreement), pursuant to which Chiesi was granted an exclusive license to commercialize pegunigalsidase alfa in all markets outside of the United States. Under the two agreements, the Company has already received a total of $95.0 million in upfront payments and to cover development costs. In addition, under the two agreements, the Company is entitled to up to $1.0 billion in potential regulatory and commercial milestone payments, tiered royalties ranging from 15% to 40% of Chiesi's net sales in the United States and tiered royalties ranging from 15% to 35% of Chiesi's net sales outside the United States, as consideration for product supply.

On a proforma basis, including the receipt of the $20.0 million milestone payment, cash and cash equivalents as of May 18, 2023 is $51.6 million.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary 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. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. 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. In addition, Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of PRX–102 (pegunigalsidase alfa).

Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs–related diseases; and others.