Analyst Conference Summary

Biotechnology

conference date: November 15, 2021 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2021 (Q3, third quarter 2021)

Forward-looking statements

Overview: Believes there is a pathway to resubmit PXR-102 to the FDA.

Basic data (GAAP):

Revenue was $12.0 million, up sequentially from $6.4 million, and up from $10.8 million year-earlier.

Net income was negative $4.2 million, up sequentially from negative $11.2 million, and up from negative $4.4 million year-earlier.

EPS was negative $0.09, up sequentially from negative $0.25, and up from negative $0.14 year-earlier.

Guidance:

Believes cash runway through 2022.

Conference Highlights:

Dror Bashan, Protalix's CEO, said "We are pleased with the progress we have made over the past few weeks with respect to the regulatory path forward with PRX-102 for the treatment of Fabry disease with both the FDA and the European Medicines Agency. Following our Type A meeting with the FDA, we believe there is now an established pathway to resubmit the PRX-102 BLA. We remain focused on our mission to bring to the market another important potential alternative treatment for all adult Fabry patients. We are grateful for the continued support from our team members, advocates and external partners who remain as steadfast and focused as ever; they see the value of having an alternative treatment for patients, especially one with our profile. Following the note exchange agreement we completed in August, we now have additional financial flexibility and sufficient capital to fund our operations through important milestones in 2022. "

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 submit an MAA to the EMA for PRX-102 during the first quarter of 2022. 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. Protalix and Chiesi had 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. Now must resubmit, could be delayed further due to the FDA need to inspect facilities in Europe and Israel. The Phase 3 BALANCE and the BRIGHT trial have completed enrollment. Initial top-line 12 month Phase 3 results from the ongoing Balance trial were released on June 2, 2021. Based on the two trials, the companies plan an EU filing. Full 24 month Balance data is expected in Q2 2022.

In October 2021 the last patient was a final dose in the Phase 3 Balance study of PRX-102. Final data is expected in Q2 2022. This data will be included in the new FDA application.

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 and PRX119 could enter clinical trials in 2022.

Revenue generated by taliglucerase alfa sales was $4.5 million, up sequentially from $3.2 million, and up from $3.3 million year-earlier. $7.5 million of revenue was from licensing and R&D services.

Cash and equivalents balance ended at $49 million, down sequentially from $77 million. Debt is $28 million in convertible notes, down sequentially from $56 million.

Cost of goods sold was $3.7 million. R&D (net of grants) expense $7.3 million. SG&A $3.0 million. Leaving an operating loss of $1.9 million. Financial expenses $2.4 million.

Q&A summary:

Type A FDA meeting, inspections of manufacturing? 2 year data with noninferiority. They are supposed to inspect the facilities once the submission is made. [WM: FDA inability to inspect overseas facilities was a reason for the delay, which led to the CRL.]

Reimbursement, marketing? We will wait for the outcome of Balance. Also that would be Chiesi's area in Europe.

Balance data presentation plans? First we will have topline results. When we have done a complete analysis we would look for a conference. Topline results are expected in Q2.

Notes paid down today were about $3 million.

Margins are hard to predict because they are a mixture of different buyers.

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