Analyst Conference Summary


Protalix Biotherapeutics

conference date: November 7, 2019 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2019 (Q3, third quarter 2019)

Forward-looking statements

Overview: Possibly near Fabry Disease therapy approval, but almost out of cash to operate; reverse-splitting stock.

Basic data (GAAP):

Revenue was $14.2 million, up sequentially from $12.2 million, and up from $12.3 million year-earlier.

Net income was negative $3.6 million, up sequentially from negative $7.7 million, and up from negative $5.3 million year-earlier.

EPS was negative $0.02, up sequentially from negative $0.05, and up from negative $0.04 year-earlier.



Conference Highlights:

Dror Bashan, Protalix's CEO, said "With three, now fully enrolled Phase III clinical trials of PRX-102, we have a robust and thorough clinical program for the treatment of Fabry disease. Our management, scientific and clinical teams are all fully committed to bringing this important treatment to the Fabry patient community."

The Company and Chiesi plan the submission of a BLA for PRX-102 via the FDA's Accelerated Approval pathway based on data from the completed Phase I/II clinical trials of PRX-102 and the ongoing Phase III BRIDGE clinical trial by April 2020. The Company announced positive 12-month interim on-treatment data from the first 16 out of the 22 adult patients (9 males and 7 females) enrolled in the BRIDGE Phase III open label switch-over study of PRX-102 for the treatment of Fabry disease. The interim data demonstrate a mean improvement in kidney function, in both male and female patients, when switched from agalsidase alfa (Replagal) to PRX-102, and will help to support the expected FDA BLA filing under Accelerated Approval

Revenue generated by taliglucerase alfa sales was $5.1 million, up flat sequentially from $3.43 million, and up from $0.7 million year-earlier.

For PRX-102, Pegunigalsidase alfa, for Fabry disease, based on the FDA discussion during our recent meeting we believe that the potential filing for accelerated approval might be based on data the Company has already generated in its clinical trials of PRX-102. The Phase 3 BRIGHT trial presented good data in June 2019. The Phase 3 BRIDGE study enrollment was completed in December 2018. The BALANCE trial is near complete enrollment. In 2018 U.S. rights were sold to Chiesi Farmaceutici S.p.A., which had already bought ex-U.S. rights. Believes already has sufficient patients for accelerated approval.

Shareholders will meet December 9, 2019 to vote on a proposal to allow a reverse stock split.

For PRX-110, Alidornase alfa, for Cystic Fibrosis, for now the focus is on other programs, to conserve cash.

OPRX-106, an oral anti-TNF for ulcerative colitis Phase 2 top line results were positive. In discussions with portential partners.

An oral version of Humira is being worked on, no timeline for moving to clinical trials.

Cash balance ended at $21.4 million, down sequentially from $25.1 million. Debt is $50.2 million in convertible notes.

Cost of revenue was $3.2 million. R&D (net of grants) expense $10.0 million. SG&A $2.6 million. Leaving an operating loss of $1.5 million. Financial expense $2.1 million.

Q&A summary:

Pre BLA FDA meeting taken place yet? Was in October. Will share when allowed.

Final Bridge data timing? Last patient out in December, so towards end of Q1 we should have final analyzed results.

Reverse split? OPX-106? Reverse split does not imply we don't have a potential partner for OPX-106. Only reason is to raise stock price to allow for more trading.

Taliglucerase ordering pattern in Brazil? We see about 23% market share, and volume growth at 15% y/y. Production is in line with sales. Pfizer has the rights globally except Brazil.

PRX-102 Balance data timing? Finished enrollment in September. 2 years to show superiority to FDA. But EU requires just 1 year. We believe Chiesi is preparing for commercial operations.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my Seeking Alpha articles.

Copyright 2019 William P. Meyers