Analyst Conference Summary

Biotechnology

conference date: March 31, 2021 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2022 (Q4, fourth quarter 2021)

Forward-looking statements

Overview:

Basic data (GAAP):

Did not give Q4 details, just full year revenue of $38.4 million, net loss of $27.6 million, and EPS loss of $0.62.

Revenue was $ million, up sequentially from $12.0 million, and up from $ million year-earlier.

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

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

Guidance:

Believes cash runway through Q3 2023.

Conference Highlights:

Dror Bashan, Protalix's CEO, said "We had a productive Type A meeting with the FDA in the fall during which the FDA, in principle, agreed that the data package proposed to the FDA for the anticipated BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. We also, together with Chiesi, submitted an MAA to the EMA, which was subsequently validated by the EMA. 2022 has the potential to be a meaningful year for the company as we move towards our BLA resubmission in the United States, await feedback on our MAA submission in Europe and continue to advance our early stage pipeline. " Topline results of the Balance study to be released soon, maybe next week.

On August 12, 2021, Protalix entered into agreements to exchanges of an aggregate of $54.65 million of the outstanding 7.50% Senior Secured Convertible Notes due 2021 for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024, $25.90 million in cash and accrued and unpaid interest through the closing date. The exchanges should be completed by November 15. At closing will have reduced debt by $28.75 million and effectively extended the maturity for substantially all of the remaining debt from 2021 until 2024.

The Company and Chiesi expect to submitted an MAA to the EMA for PRX-102 on February 24, 2022. 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. In September 2021 the FDA agreed in principle to accept a resubmission which will include the future results of the Balance study, so application would be 2H 2022. Had received a Complete Response Letter on the PDUFA date, April 28, 2021. Full 24 month Balance trial data is expected in Q2 2022.

On March 18, 2022, the Company, together with Chiesi, announced positive final results from the phase III BRIGHT clinical trial, a multicenter, 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 (a total of 14 infusions) in adult patients previously treated with a commercially available enzyme replacement therapy (ERT) (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 PRX–102 treatment in adult Fabry patients.

Because of the CLR Protalix decided to raise funds by entering, in May 2021, a new agreement with Chiesi. Protalix recieved a $10 million milestone payment in exchange for a $25 million reduction in a later potential milestone. Also On July 2, 2021, entered into an ATM Sales Agreement with H.C. Wainwrigh to sell, shares of its common stock up to an aggregate offering price of $20.0 million. Protalix terminated the ATM Equity Offering Sales Agreement it had previously entered into with BofA Securities, Inc.

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.

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.

Full year 2021 revenue generated by taliglucerase alfa sales was $16.7 million, up from $16.2 million year-earlier. $21.6 million of revenue was from licensing and R&D services.

Cash and equivalents balance ended at $39 million, down sequentially from $49 million. Debt is $28 million in convertible notes due in 2024.

Q4 2021 expenses not state. Full year 2021 cost of goods sold was $16.3 million. R&D (net of grants) expense $29.7 million. SG&A $12.7 million. Leaving an operating loss of $20.5 million. Financial expenses $7.5 million.

Q&A summary:

Chianti rare disease sales team? They have a team and infrastructure, on each of the contintents.

PRX-102 resubmission? After we have the final results it takes a couple of months to complete the submissions needed.

R&D expense trend? We will invest more in the early stage pipeline, but most 102 costs are behind us. So possibly up a little y/y.

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