Analyst Conference Summary

Biotechnology

conference date: November 14, 2022 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2022 (Q3, third quarter 2022)

Forward-looking statements

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

Basic data (GAAP):

Revenue was $14.2 million, sequentially from $na million, and up 17% from $12.1 million year-earlier.

Net income was negative $3.6 million, up sequentially from negative $5.3 million, and up from negative $4.2 million year-earlier.

EPS was negative $0.07, up sequentially from negative $0.11, and up from negative $0.09 year-earlier.

Guidance:

Believes cash runway through Q4 2023.

Conference Highlights:

Dror Bashan, Protalix's CEO, said "We are happy we have reached a significant milestone for our company with the recent BLA resubmission to the FDA. We believe PRX-102, if approved, has the potential to significantly impact patients living with this rare, life-threatening genetic disease. As we approach potential approval and commercialization of PRX-102, we affirm our dedication to our mission of bringing new medicines to patients with serious diseases. " Protalix is also stablishing a pipeline of early-stage molecules, with some possibly coming to the clinic next year.

On November 9, 2022 partner Chiesi Farmaceutici resubmitted a BLA to the FDA for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease. It included the final two year analyses of our phase III BALANCE clinical trial and long-term data from our open-label extension study of in adult patients treated with a 2 mg/kg every four weeks dosage. The initial BLA included a comprehensive set of preclinical, clinical and manufacturing data compiled from our completed phase I/II clinical trial of PRX 102, including the related extension study, interim clinical data from our phase III BRIDGE clinical trial and safety data from our on-going clinical studies of PRX 102 in adult patients receiving 1 mg/kg every two weeks. On April 4, 2022, Protalix, together with Chiesi, had 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. CSR is complete as of August 2022. 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 $8.8 million, up from $4.5 million year-earlier; from license and R&D services was $5.4 million, down y/y from $7.5 million.

Has other potential therapies in preclinical development. PRX-115 for refractory gout could enter a Phase 1 clinical trial in Q1 2023. PRX119 still in preclinical work on identifying a potential target.

Cash and equivalents balance ended at $21 million, down sequentially from $28 million. Debt is $28 million in convertible notes due in 2024.

Cost of goods sold was $5.4 million. R&D (net of grants) expense $7.4 million. SG&A $2.8 million. Leaving an operating loss of $3.1 million. Financial expenses $0.4 million.

Q&A summary:

When will the agreement with Chiesi for PRX-102 be shared? We will not be sharing the agreement. When we hit milestones we will report them.

PRX-115 preclinical data? We feel comfortable to continue. We will discuss in more detail once we have Phase 1 data. We should have final results in late 2023 or early 2024.

PRX-115 competitive landscape? It will be easier to differentiate when we have Phase 1 results.

Brazil election, any impact? We see no major changes. Our prices are competitive.

Pfizer sales in Europe? We do not believe they have launched in Europe.

We have hopes that Chiesi will do well in the market, given the data and the competition.

Chiesi rare disease division commercialization? They have a couple of drugs on the market already. They are ready to go with PRX-102 in both the U.S. and Europe.

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