On march 6, 2018 Protalix BioTherapeutics, Inc. (NYSE American: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, 2017 and provided a corporate update (Press release, Protalix, MAR 6, 2018, View Source;p=RssLanding&cat=news&id=2336416 [SID1234524462]).
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"This has been an exciting year with a great partnership deal and good progress in all of our clinical programs," said Moshe Manor, Protalix’s President and Chief Executive Officer. "Looking ahead to 2018, we expect to generate and release more data regarding our clinical trials, and to continue the progress of our programs, both with potential partners and with our current partner, Chiesi Farmaceutici."
2017 and Recent Clinical and Corporate Highlights
Pegunigalsidase (PRX-102) for Fabry Disease
The Company has over 40 clinical trial sites actively recruiting patients for three trials, a significant portion of which are located in the United States. The trials are being run by leading opinion leaders in the Fabry disease field.
The Company expects to finalize enrollment in all three Fabry trials during 2018.
Pegunigalsidase alfa granted Fast Track designation from the U.S. Food and Drug Administration; the designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Pegunigalsidase alfa granted Orphan Drug Designation by the European Commission which qualifies the Company for access to the centralized marketing authorization procedure, including applications for inspections and for protocol assistance. The designation was based on the Company having established medically plausible evidence that pegunigalsidase alfa will provide a significant benefit over existing treatments in the European Union for the treatment of Fabry disease.
Alidornase (PRX-110) for Cystic Fibrosis
The Cystic Fibrosis Foundation Grant Review is in the final stages of completion.
Oral antiTNF (OPRX-106) for Ulcerative Colitis
The Company expects to release top-line data this month, with full data planned to be presented in a medical conference later in the year.
Interim data was positive, with initial signs of efficacy across multiple clinically meaningful endpoints.
Alfataliglicerase for Gaucher Disease
The Company recognized alfataliglicerase sales of $7.1 million in Brazil for 2017. In addition, the Company shipped approximately $2.6 million worth of the drug during the current quarter.
Full-Year 2017 Financial Results
The Company recorded total revenues of $19.2 million during the year ended December 31, 2017, compared to $9.2 million for the same period of 2016. The increase resulted from an increase equal to $3.0 million of products sold to Brazil, and $7.0 million of drug substance sold to Pfizer Inc.
Research and development expenses for the year ended December 31, 2017, were $28.8 million, compared to $24.6 million for the same period in 2016. Selling, general and administrative expenses for the year ended December 31, 2017 were $11.5 million, compared to $9.4 million incurred during the same period in 2016.
Operating loss for the year ended December 31, 2017 was $36.4 million compared to $33.2 million for the year ended December 31, 2016.
For the year ended December 31, 2017, the Company reported a net loss of $47.2 million, excluding a one-time, non-cash net charge of $38.1 million in connection with the remeasurement of a derivative, or $0.36 per share, basic and diluted, compared to a net loss of $29.4 million, or $0.29 per share, basic and diluted, for the same period of 2016.
On December 31, 2017, the Company had $51.2 million of cash and cash equivalents, compared to $63.3 million at December 31, 2016, which is currently projected to fund operations into 2020. As of December 31, 2017, the Company had outstanding $5.9 million of its 4.5% convertible notes due September 2018 and $59.1 million of its 7.5% senior secured convertible notes due November 2021.
Conference Call and Webcast Information
The Company will host a conference call on Tuesday, March 6, 2018, at 8:30 am ET to review the clinical, corporate and financial highlights.
To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 2636229.
The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software