conference date: March 16, 2017 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2016 (fourth quarter 2016)
Overview: Although Protalix has a commercial product, the focus is on developing new products, so it is a long way from profitability.
Basic data (GAAP):
These results are for full year 2016 vs. 2015:
Revenue was $9.2 million, up 109% from $4.4 million in 2015.
Net income was negative $29.4 million, way down from $58.0 million in 2015. But net loss from continuing operations in 2015 was $27.3 million.
EPS was negative $0.29, down from $0.61 in 2015
"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,”said Moshe Manor, Protalix’s CEO.
For PRX-102, Pegunigalsidase alfa, for Fabry disease interim Phase 2 data was positive. The Phase 3 study started enrollment in October, with completion of enrollment expected in 2017. 12-month interim data analysis expected in 2H 2018. It is a 24 month study.
For PRX-110, Alidornase alfa, for Cystic Fibrosis, positive interim Phase 2 results were reported in January 2017. Full results are expected in April 2017.
OPRX-106, an oral anti-TNF for ulcerative colitis enrolled its first Phase 2 patient in November 2016, with full results expected near year-end 2017.
Brazil has confirmed it will purchase about $24 million of alfataliglicerase for Gaucher Disease starting mid-2017. It also granted pediatric approval (ages 4 and older) in November.
Cash balance ended at $63.3 million. $73 million in convertible notes due in 2021 are outstanding. Company should be funded through data readouts.
102 results criteria for success? If we reach a 2 point improvement in FPP1, physicians indicate that would be good.
Partnering 102 thoughts? First we need the data analysed.
Brazil revenue compared to 2016? Just $4 million in 2016. Expect $24 million, with first shipment midyear, with annual run rate of $40 million. We will update you when we can.
Conversion price on Senior Convertible notes? $0.85.
Pfizer sales? We deliver at their request, but 2016 made up for 2015.
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