On March 16, 2017 Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the full-year ended December 31, 2016, and provided a corporate update (Press release, Protalix, MAR 16, 2017, View Source;p=RssLanding&cat=news&id=2254401 [SID1234518199]).
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"Recently, our Executive Vice President, Research and Development and two Principal Investigators that have been involved in our clinical trials of pegunigalsidase alfa for Fabry disease each gave presentations at the 13th Annual WORLDSymposium in San Diego on the data generated in our phase I/II clinical trial of pegunigalsidase alfa for the treatment of Fabry disease, and received very positive feedback from physicians and patient advocacy groups," said Moshe Manor, Protalix’s President and Chief Executive Officer. "Looking ahead into 2017, we anticipate reporting results from both the phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis and the phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. In 2018, if we generate positive interim results from the pegunigalsidase phase II trial, we expect to begin the filing process for approval with the European Medicines Agency."
"Following a note exchange and private placement completed in December 2016, we have a strong cash position of approximately $63.3 million," said Yossi Maimon, Protalix’s Vice President and Chief Financial Officer. "We anticipate these funds will be sufficient to fund our operations into 2019."
2016 and Recent Clinical and Corporate Highlights
Pegunigalsidase alfa (PRX-102) for Fabry Disease
Announced positive six and twelve-month interim phase II data in March 2016 and reported final results of the trial in August 2016. This data was presented at the Society of Inborn Errors of Metabolism Annual Symposium in September 2016 and the 13th Annual WORLDSymposium in February 2017.
Enrolled the first patient in a global phase III clinical trial to support filings in the United States (U.S.) and Europe in October 2016. Completion of enrollment is expected during the second half of 2017, with interim data analysis anticipated in 2018 to support European Medicines Agency and other regulatory filings outside of the United States, which comprise approximately two-thirds of the market.
Alidornase alfa (PRX-110) for Cystic Fibrosis
Reported positive interim results from the first 13 patients treated in our phase II clinical trial in January 2017. Full results for all 16 patients enrolled in the study are expected in the first half of April 2017. Data from the study was accepted as an oral presentation at the 40th European Cystic Fibrosis Conference to be held in June 2017.
Oral anti-TNF (OPRX-106) for Ulcerative Colitis
Enrolled the first patient in a phase II clinical trial in November 2016. Full results are expected around year end.
Alfataliglicerase for Gaucher Disease
Granted pediatric approval of alfataliglicerase in Brazil for the treatment of Gaucher disease in children four years of age and older in November 2016.
Received letter detailing and confirming purchases of approximately $24 million of drug product from Fundação Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health in December 2016.
Full-Year 2016 Financial Results
For the year ended December 31, 2016, Protalix reported a net loss of $29.4 million, or $0.29 per share, basic and diluted, compared to a net loss of $27.3 million, or $0.29 per share, basic and diluted, for the year ended December 31, 2015 from continuing operations.
Protalix recorded total revenues of $9.2 million for the full-year 2016, compared to $4.4 million during the same period of 2015. The increase is attributable mainly to increased sales of drug substance to Pfizer Inc. for inventory build up.
Research and development expenses for full-year 2016 were $24.6 million, compared to $20.0 million for the same period in 2015. Selling, general and administrative expenses for the full-year 2016 were $9.4 million, compared to $7.3 million incurred for the full-year 2015. The increase is mainly attributable to increased activities in Brazil.
At December 31, 2016, Protalix had $63.3 million of cash and cash equivalents, compared to $76.4 million at December 31, 2015, which is currently projected to fund operations into 2019.
– Protalix exchanged $54.1 million principal amount of the Company’s $69.0 million 4.50% Senior Convertible Notes due 2018 for $40.2 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2021 and approximately 23.8 million shares of common stock in December 2016.
– Concurrent to the note exchange, the Company sold $22.5 million principal amount of the 7.50% Senior Secured Convertible Notes due 2021 in a private placement.