Analyst Conference Summary


Protalix Biotherapeutics

conference date: May 9, 2018 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2018 (Q1, first quarter 2018)

Forward-looking statements

Overview: Continues pipeline development and discussions with possible partners. Revenue remains very lumpy.

Basic data (GAAP):

Revenue was $4.6 million, up 92% sequentially from $2.4 million, and up 59% from $2.9 million year-earlier.

Net income was negative $9.4 million, up sequentially from negative $15.1 million, and down from negative $8.4 million year-earlier.

EPS was negative $0.06, up sequentially from negative $0.11, and down from negative $0.07 year-earlier.



Conference Highlights:

Moshe Manor, Protalix’s CEO, said "We continue to execute against our upcoming milestones, including the completion of enrollment in our phase III clinical trials of PRX-102 and exploring potential partnering opportunities for our clinical assets. We reported positive results for OPRX-106 in the first quarter of this year, which not only demonstrate the drug’s potential in the treatment of ulcerative colitis, but also highlight the potential of our ProCellEx platform technology to deliver biologics orally."

Protalix has no plans to raise money using a dilutive stock issue.

Revenue is generated by taliglucerase alfa sales.

For PRX-102, Pegunigalsidase alfa, for Fabry disease Phase 3 studies continued enrollment, with completion expected in 2018. Blood sample data will be released late in May. 12-month interim data analysis expected in 1H 2019. It is a 24 month study. [See PRX-102 press release for details] In October the ex-U.S. rights were sold to Chiesi Farmaceutici S.p.A, with Protalix to receive $25 million upfront, an additional up to $25 million in development costs and an additional up to $320 million in potential regulatory and commercial milestone payments. If commercialized Protalix to receive tiered royalties ranging from 15% to 35% on net sales. PRX-102 received Fast Track designation in the U.S. and Orphan Drug designation in the EU.

For PRX-110, Alidornase alfa, for Cystic Fibrosis, the foundation grant is still under review. In active discussions with potential partners.

OPRX-106, an oral anti-TNF for ulcerative colitis Phase 2 top line results were positive. 67% of patients experienced a clinical response. Partnership discussions have begun. Data will be presented at a meeting in early June.

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

Cash balance ended at $41.3 million, down sequentially from $51.2 million. $52 million in convertible notes due in 2021 are outstanding. Cash used in operations

Believes has funding into 2020 using present cash only. Chiesi agreement could pay off a significant amount of convertible notes.

Cost of revenue was $2,9 million, leaving gross profit of $1,6 million. R&D (net of grants) expense $6.4 million. SG&A $2.5 million. Leaving an operating loss of $7.3 million. Financial expense $2.2 million, financial income $0.1 million.

Expects to see cash consumption decrease as a result of the Chiesi pickup of R&D costs.


Are all planned clinical sites open for enrollment? Yes. Sites are in the U.S. and around the globe, we have more sites than initially envisioned.

OPRX-106 partnerships? We will have more data in about a month, which will help us in discussions. There is a lot of interest, but we do not want to over-promise.

Brazil sales outlook? We see an increasing number of patients. Shipment timing is uncertain.

PRX-102 data timeline? We don't expect interim data in 2018, but will report end of enrollment. We will also report some data on blood chemistry in 3 weeks.

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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 blog and Seeking Alpha articles.

Copyright 2018 William P. Meyers