Analyst Conference Summary

Biotechnology

conference date: March 30, 2021 @ 5:30 AM Pacific Time
for quarter ending: December 30, 2020 (Q4, fourth quarter 2020)

Forward-looking statements

Overview: Waiting for the FDA, not clear when facility inspection will take place, but PDUFA date is still April 27.

Basic data (GAAP):

Q4 2021 results not stated. Full year results below above Q&A.

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

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

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

Guidance:

Believes cash runway to Q2 2022.

Conference Highlights:

Dror Bashan, Protalix's CEO, said "We expect 2021 will also be an important year for Protalix as we await the FDA's review of the PRX–102 BLA on the upcoming April 27, 2021 PDUFA date. We are grateful to our employees and external partners for their commitment and dedication during a very challenging time with the global pandemic. We look forward to continuing to build stockholder value."

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 was set at January 27, 2021, but that was then delayed to April 27, 2021 due to the pandemic. It could be delayed further due to the FDA need to inspect a facility in Europe. The Phase 3 BALANCE and the BRIGHT trial have completed enrollment.

On February 23, 2021, Chiesi and Protaliz, announced positive topline results from the phase III BRIGHT clinical trial, of PRX–102, 2 mg/kg every four weeks, in up to 30 patients with Fabry disease previously treated with agalsidase alfa (Replagal) or agalsidase beta (Fabrazyme). Topline results indicate that PRX-102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients.

On December 30, 2020, Protalix and Chiesi announced final study results from the phase III BRIDGE clinical trial, a 12–month open-label, single arm switch-over study evaluating the safety and efficacy of PRX–102, 1 mg/kg infused every two weeks, in up to 22 Fabry patients. It showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched.

On February 17, 2021, the Company successfully completed a public offering of its common stock raising gross proceeds of approximately $40.2 million at $4.60 per share.

On February 10, 2021, Protalix entered into an exclusive partnership with SarcoMed USA for the worldwide development and commercialization of alidornase alfa (PRX-110), for use in the treatment of any human respiratory disease including, sarcoidosis, pulmonary fibrosis and other related diseases via inhaled delivery.

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

Has other potential therapies in preclinical development. PRX115 and PRX119 could enter clinical trials in 2022.

Revenue generated by taliglucerase alfa sales was $na million, down sequentially from $3.3 million, and up from $ million year-earlier. $ 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 $38 million, down sequentially from $41 million. Debt is $54 million in convertible notes. Raised about $49 million in Q1 2021.

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

Full year 2020 revenue was $63 million. Net loss was $9 million. Net loss per share was $0.22.

Q&A summary:

Revenue expectations for taliglucerase alfa in 2021? About the same as 2020, $16 million.

PRX-102 PDUFA date? We hope to launch soon after approval, and also publish more data in Q2, which could allow for an EU submission. Will not release pricing until after approval.

BRIGHT study label implications? The outcome is not in the BLA, so will submit a supplement if approved.

Inhaled delivery? Looking at it for PRX-110.

FDA delays? When we have updates on our inspections, we will share them.

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