Analyst Conference Summary


Protalix Biotherapeutics

conference date: May 6, 2019 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2019 (Q1, first quarter 2019)

Forward-looking statements

Overview: Is in discussion with FDA for potential accelerated approval of PRX-102 for Fabry disease, with enrollment almost complete.

Basic data (GAAP):

Revenue was $10.44 million, % sequentially from $na million, and up 55% from $6.71 million year-earlier.

Net income was negative $7.26 million, down sequentially from negative $na million, and about flat from $7.24 million year-earlier.

EPS was negative $0.05, down sequentially from negative $na, and down from $0.05 year-earlier.


Cash sufficient into 2020, possibly through filing for PRX-102, which would trigger a milestone payment from Chiesi.

Conference Highlights:

Moshe Manor, Protalix's CEO, said "In the first three months of 2019, we have continued to execute on enrollment in our PRX-102 studies and have worked to prepare ourselves for a potential accelerated approval path. In addition, we are encouraged by the initial pharmacokinetic (PK) data from our BRIGHT study, which were presented at the 15th Annual WORLD Symposium in February 2019, that demonstrate the potential for PRX-102 to be infused once-monthly, compared to the current treatment regimen of every two weeks."

Working hard to get PRX-102 across the finish line. We are excited by the data reported so far.

Revenue generated by taliglucerase alfa sales was $3.53 million, down 22% from $4.55 million in Q1 2018.

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 is one patient away from complete enrollment. The Phase 3 BRIDGE study enrollment was completed in December 2018. As of today, the BALANCE trial is 11 patients away from complete enrollment. The Company is scheduled to present three posters during the 6th Update on Fabry Disease international conference being held in Prague, Czech Republic, on May 26-28, 2019. In 2018 U.S. rights were sold to Chiesi Farmaceutici S.p.A., which had already bought ex-U.S. rights. Will discuss regulatory path with FDA in Q2 2019, believes already has sufficient patients for accelerated approval.

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 $30.4 million, down sequentially from $37.8 million. Debt is $48.7 million in convertible notes.

Believes has funding into 2020 using present cash only. R&D expense will be reduced as Chiesi assumes responsibility.

Cost of revenue was $2.0 million. R&D (net of grants) expense $11.7 million. SG&A $2.2 million. Leaving an operating loss of $5.5 million. Financial expense $1.9 million, financial income $0.2 million.

Q&A summary:

BRIDGE data availability? End of 2019.

Taliglucerase alfa patients in Brazil? Over 130 patients, over a 20% share of the market.

OPRX-106? We are still deciding whether to do it on our own or with a collaborator.

Product to Pfizer in the quarter? $1.4 million to Pfizer.

PRX-102 duration of therapy so far? We have some patients on the drug and extension for well over one year. In the BRIGHT study we will share more data of patients on drug for at least 12 months.

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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