Analyst Conference Summary

Biotechnology

conference date: October 30, 2020 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2020 (Q3, third quarter 2020) Note: was scheduled for the 29th, delayed due to tech difficulties.

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $10.8 million, down sequentially from $11.0 million, and down from $14.2 million year-earlier.

Net income was negative $4.4 million, down sequentially from negative $4.2 million, and up from negative $3.6 million year-earlier.

EPS was negative $0.14, down sequentially from negative $0.13, and up from negative $0.24 year-earlier.

Guidance:

none

Conference Highlights:

Dror Bashan, Protalix's CEO, said "We have accomplished a lot over the last several months. Importantly, we have announced that FDA accepted the BLA filing of PRX-102 for Fabry disease, and set a cutoff date of January 27, 2021. The last patient completed treatment in our PHASE-III BRIGHT study, and we expect to report top line data from this study in the first quarter of 2021. We, together with our development and commercialization partner Chiesi Global Rare Diseases, launched and expanded access program in the US and this will help us to continue indeed, our clinical data set. Finally, we regain the New York stock exchange compliant in early September and announced an entry into a $30 million in the market equity offering program with Bank of America Securities in October."

Protalix and Chiesi submitted the BLA for PRX-102, Pegunigalsidase alfa, for Fabry disease, on May 27, 2020 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. The PDUFA date is set at January 27, 2021, but that is dependent on the ability of the FDA to inspect facilities in Europe and Israel, which is problematic due to the pandemic. The company has requested a meeting with the FDA to resolve the issue. The Company had 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 and the BRIGHT trial have completed enrollment.

In Q3 2020 Protalix launched an at-the-market equity offering program with BofA Securities enabling the Company to sell up to $30 million shares of common stock according to the terms and conditions set forth in its agreement with BofA Securities.

Expanded access program for PRX-102 was launched in October 2020.

Revenue generated by taliglucerase alfa sales was $3.3 million, down sequentially from $3.6 million, and up from $5.1 million year-earlier. $7.5 million of revenue was from licensing and R&D services.

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

Cash and equivalents balance ended at $41.3 million, up sequentially from $40 million. Debt is $53 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:

How many U.S. and EU patients in 2019, how many on therapy? A couple of thousand on the continent, but a larger number are undiagnosed. Enzyme replacement therapies, mainly Fabrazyme, dominate the market.

Expanded access program does not depend on Phase 3.

What would affect the launch? Approval is expected to be for all Fabry patients. Our study outcomes should help us with the launch. We do need to publish the results before we apply to EU authorities. Once in four weeks regimen will also be attractive.

Pediatric trials? Fabrazyme is approved for children. Our pediatric study is planned.

Plans for deals in next twelve months? We are talking to potential partners about both licensing our technology and potentially licensing in technology.

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