Analyst Conference Summary

Biotechnology

conference date: May 16, 2022 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2022 (Q1, first quarter 2022)

Forward-looking statements

Overview: Preparing data for admission to the FDA. Already submitted in EU.

Basic data (GAAP):

Revenue was $16 million, up sequentially from $na million, and up from $11 million year-earlier.

Net income was negative $2 million, up sequentially from negative $na million, and up from negative $5 million year-earlier.

EPS was negative $0.05, up sequentially from negative $na, and up from negative $0.14 year-earlier.

Guidance:

Believes cash runway through Q3 2023.

Conference Highlights:

Dror Bashan, Protalix's CEO, said "We are proud of the great progress Protalix has made throughout the first quarter in advancing our Fabry disease candidate PRX-102. The announcement of compelling results from both the BRIGHT and BALANCE phase III trials marks a significant milestone, as we have now completed three phase III studies supporting the planned BLA resubmission to the U.S. Food and Drug Administration later this year. As we work toward potential approval and commercialization, we remain focused on our mission of bringing this important treatment option to patients with Fabry disease, while continuing to advance our early stage pipeline."

On April 4, 2022, Protalix, together with Chiesi, announced positive top-line results from its phase III BALANCE clinical trial, a 24-month, randomized, double-blind, active control study of 1 mg/kg of PRX–102 administered every other week for Fabry disease compared to agalsidase beta in patients previously treated with agalsidase beta for at least one year. The study met its primary endpoint and demonstrated that PRX-102 was statistically non-inferior to agalsidase beta, as measured by estimated glomerular filtration rate (eGFR) slope. Results showed a favorable tolerability profile for PRX-102, consistent with results from the Company's prior trials. On March 18, 2022, together with Chiesi, we announced positive final results from its phase III BRIGHT clinical trial, multinational open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of treatment with 2 mg/kg of PRX-102 administered every four weeks for 52 weeks in adult patients previously treated with a commercially available enzyme replacement therapy (Fabrazyme or Replagal). Results of the BRIGHT study indicate that 2 mg/kg of PRX–102 administered by intravenous infusion every four weeks was well tolerated, and Fabry disease assessed by eGFR slope and plasma lyso-Gb3 was stable throughout treatment.

The Company and Chiesi submitted an MAA to the EMA for PRX-102 on February 24, 2022. The submission was validated by the EMA. The MAA included final data from the Company's phase III BRIDGE and BRIGHT clinical trials; 12–month interim data from the Company's phase III BALANCE clinical trial; and final data from the Company's phase I/II clinical trial data from naïve/untreated patients, including the extension study related thereto, using 1 mg/kg every other week dosing. The submission followed an October 2021 meeting with the EMA's Rapporteur and Co-Rapporteur at which we and Chiesi discussed the scope of the anticipated submission, and the Rapporteur and Co-Rapporteur were generally supportive of a planned MAA submission.

The Fabry market is about $2 billion.

Revenue from sales of taliglucerase alfa was $9.0 million, up from $4.5 million year-earlier; from license and R&D services was $7.0 million, flat y/y.

Has other potential therapies in preclinical development. PRX115 for refractory gout could enter clinical trials in 2023. PRX119 still working on identifying a potential target.

Cash and equivalents balance ended at $33 million, down sequentially from $39 million. Debt is $28 million in convertible notes due in 2024.

Cost of goods sold was $6 million. R&D (net of grants) expense $9 million. SG&A $3 million. Leaving an operating loss of $2 million. Financial expenses $0.4 million.

Q&A summary:

Clock stop for EMA submission? We are waiting for input from the EMA.

UK market? Good question, will need to get back on whether EMA approval counts in UK.

We are analysing and finalizing the data for submission.

Net loss v. cash used in operations? Net loss includes depreciation and share compensation, which are non-cash. Our quarterly run rate is about $6 million.

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