On November 15, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the third quarter ended September 30, 2021 and provided a financial and business update on recent corporate, clinical and regulatory developments (Press release, Protalix, NOV 15, 2021, View Source [SID1234595548]).
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"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 U.S. Food and Drug Administration and the European Medicines Agency," stated Dror Bashan, Protalix’s President and Chief Executive Officer. "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. We are committed to executing our strategy and are looking forward to converting the momentum of the last quarter into a successful 2022."
2021 Third Quarter and Recent Business Update
Regulatory Updates
On October 11, 2021, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, provided a regulatory update regarding PRX-102, which included the announcement of the receipt of the official Type A (End-of-Review) meeting minutes from the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received in April 2021 for the biologics license application (BLA) for PRX–102 for the treatment of adult patients with Fabry disease, and confirming the pathway for resubmission of a BLA for PRX–102. The PRX–102 biologics license application (BLA) resubmission to the FDA is anticipated in the second half of 2022.
On October 8, 2021, the Company, together with Chiesi, held a meeting with the Rapporteur and Co-Rapporteur of the European Medicines Agency (EMA) regarding PRX-102. At the meeting, Chiesi and the Company discussed the scope of the anticipated Marketing Authorization Application (MAA) submission for the European Union, and the Rapporteur and Co-Rapporteur were generally supportive of a planned MAA submission for PRX-102. This is an important step in the necessary pre-submission activities leading up to a MAA submission. The Company and Chiesi expect to submit an MAA to the EMA for PRX-102 during the first quarter of 2022.
Clinical Advancements
On October 15, 2021, the Company, together with Chiesi, announced the final dosing of the last patient in the Company’s phase III BALANCE clinical trial, or the BALANCE study, for the proposed treatment of Fabry disease. The BALANCE study is a 24-month, randomized, double blind, active control study of PRX-102 in Fabry patients with impaired renal function. Unblinded final data is anticipated to be released in the second quarter of 2022 after all remaining patients have completed the 24-month treatment period.
Given the changed regulatory landscape in the United States, the planned data package for the PRX-102 BLA resubmission will include the final two-year analyses of the BALANCE study.
Corporate & Financial Developments
On August 25, 2021, the Company completed exchanges, or the Exchanges, of a substantial majority of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021, or the 2021 Notes, with institutional note holders. In the Exchanges, an aggregate of $54.65 million principal amount of outstanding 2021 Notes were exchanged 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 approximately $1.1 million in cash representing accrued and unpaid interest through the closing date of the Exchanges.
The maturity date of the 2021 Notes is November 15, 2021, on which date the Company is required to settle all of the remaining 2021 Notes then outstanding, and pay all accrued but unpaid interest thereon. On November 9, 2021, the Company delivered the necessary funds under the indenture governing the 2021 Notes to effectively discharge the remaining outstanding 2021 Notes.
Third Quarter 2021 Financial Highlights
The Company recorded revenues from selling goods of $4.5 million during the three months ended September 30, 2021, an increase of $1.2 million, or 36%, compared to revenues of $3.3 million for the same period of 2020.
Revenues from license and R&D services for the three months ended September 30, 2021 and September 30, 2020 were $7.5 million. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. A revenue increase of $1.0 million recognized from the Kirin feasibility study was offset by a $1.0 million decrease in revenue generated under the Company’s license and supply agreements with Chiesi.
Cost of goods sold for the three months ended September 30, 2021 was $3.7 million, an increase of $0.8 million, or 28%, compared to $2.9 million for the same period in 2020. The increase resulted primarily from higher sales.
Research and development expenses for the three months ended September 30, 2021 were $7.3 million, a decrease of $0.4 million, or 5%, compared to $7.7 million for the same period of 2020. The decrease was primarily the result of the completion of two out of the three phase III clinical trials of PRX–102 and reduced costs related to the BALANCE study. The Company expects research and development expenses to continue to be its primary expense as it enters into a more advanced stage of preclinical and clinical trials for certain product candidates.
Selling, general and administrative expenses were $3.0 million, an increase of $0.2 million, or 7%, for the three months ended September 30, 2021 compared to $2.8 million for the same period in 2020. The increase is primarily the result of an increase of $0.4 million in corporate costs mainly related to insurance and a $0.2 million increase in sales and marketing costs, partially offset by a decrease of $0.5 million in share-based compensation.
Financial expenses, net, were $2.3 million for the three months ended September 30, 2021 and $1.9 million for the three months ended September 30, 2020. The increase resulted primarily from loss on extinguishment related to the Exchanges of the Company’s 2021 Notes.
Cash, cash equivalents and short-term bank deposits were approximately $48.7 million at September 30, 2021.
Net loss for the three months ended September 30, 2021 was approximately $4.2 million, or $0.09 per share, basic and diluted, compared to a net loss of $4.4 million, or $0.14 per share, basic and diluted, for the same period in 2020.
Conference Call and Webcast Information
The Company will host a conference call today, November 15, 2021, at 8:30 am Eastern Standard Time, to review the corporate, clinical and regulatory developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:
Webcast Details:
Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.
The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.