Analyst Conference Summary


Protalix Biotherapeutics

conference date: March 12, 2020 @ 5:30 AM Pacific Time
for quarter ending: December 30, 2020 (Q4, fourth quarter 2020)

Forward-looking statements


Basic data (GAAP):

Revenue was $3.8 million, down sequentially from $14.2 million, and up from $1.8 million year-earlier.

Net income was $0.3 million, up sequentially from negative $3.6 million, and up from negative $5.4 million year-earlier.

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



Conference Highlights:

Dror Bashan, Protalix's CEO, said "We are increasingly enthusiastic about our PRX-102 asset now that we have three ongoing, fully-enrolled Phase III clinical trials of PRX-102, and as we anticipate our BLA submission to the U.S. Food and Drug Administration under the Accelerated Approval pathway next quarter. Furthermore, we anticipate the final results of our BRIDGE and BRIGHT trials in the first and second halves of 2020, respectively, which will further support our portfolio of data regarding PRX-102. Protalix is firing on all cylinders right now, and the energy among the entire staff reached a new pinnacle in 2019. We anticipate 2020 to be a banner year for Protalix as we increase our focus on advancing our clinical pipeline, expanding sales in Brazil of Elelyso, our enzyme replacement therapy for the treatment of Gaucher disease, and leveraging commercial opportunities to expand our global footprint in the treatment of Fabry disease."

Protalix and Chiesi plan the submission of a BLA for PRX-102, Pegunigalsidase alfa, 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 in 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. The Phase 3 BALANCE trial, comparing to Fabrazyme) has completed enrollment. The BRIGHT trial also completed enrollment. In February 2020, Protalix and Chiesi announced the receipt of an agreement letter from the FDA for the Initial Pediatric Study Plan (iPSP) for PRX-102 for the treatment of Fabry disease.

Protalix on March 11, 2020 secured securities purchase agreements to raise proceeds equal to $43.7 million through a private financing with a number of leading Israeli and U.S. investors.

In December stockholders approved a 10-1 reverse stock split.

Revenue generated by taliglucerase alfa sales was $3.8 million, down sequentially from $5.1 million, and up from $1.8 million year-earlier.

For PRX-102,, for Fabry disease, in 2018 U.S. rights were sold to Chiesi Farmaceutici S.p.A., which had already bought ex-U.S. rights.

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 $17.8 million, down sequentially from $21.4 million. Debt is $48 million in convertible notes.

Cost of revenue was $ million. R&D (net of grants) expense $9.6 million. SG&A $3.0 million. Leaving an operating loss of $ million. Financial expense $ million.

Q&A summary:

Coronavirus impact on operations? Protalix makes the product and conducts the trial, so no clear impact from Chiesi, but communicating. No delays expected.

Topline BRIDGE results? April.

Chiesi strategy in U.S.? They are already investing in a salesforce in the U.S. and EU.

Pricing? No details, but if approved, data should support our taking market share from the established products.

Revenue expectations from Brazil? Expect 10% to 15% y/y sales growth.

110, 102 plans? Reviewing with an outside consultant.

First Chiesi milestone? Triggered by interim analysis and FDA approval. Not releasing amounts for milestones.

Cash burn rate? First half expectation is $7.5 million rate, but should decrease in second half. The financing we received should get us through two years. That excludes the possible Chiesi milestones.

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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 2020 William P. Meyers