Protalix BioTherapeutics, Inc. (AMEX:PLX) Q3 2023 Earnings Call Transcript

Protalix BioTherapeutics, Inc. (AMEX:PLX) Q3 2023 Earnings Call Transcript November 6, 2023

Protalix BioTherapeutics, Inc. beats earnings expectations. Reported EPS is $-0.04, expectations were $-0.07.

Operator: Good morning, ladies and gentlemen. And welcome to the Protalix Biotherapeutics Third Quarter 2023 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mr. Chuck Padala of LifeSci Advisors, Investor Relations for Protalix. You may begin the conference.

Chuck Padala: Thank you, operator and welcome to the Protalix Biotherapeutics Third Quarter 2023 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Protalix; and Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the results and the update was issued this morning and is now available on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release in this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in the Protalix's filing with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror?

A biopharmaceutical researcher observing a test tube full of interleukins in a lab.

Dror Bashan: Thank you, Chuck. And welcome everyone to our third quarter 2023 financial results and business update call. Before we begin, I would like to take a moment to acknowledge the situation here in Israel. We at Protalix are horrified by the devastating events that have been taking place in recent weeks. It is an extremely challenging time and we are heartbroken for the victims, families, friends and loved ones, many of us being personally impacted. Our hearts and prayers go out to all these those affected and we remain dedicated to the safety and wellbeing of our team. We are committed to provide our families, friends and colleagues any and all support they need at this time. At the same time, we want to reassure you that we are continuing to operate as usual.

There have been no disruptions to our facilities and we do not currently anticipate any interruption to the supply of our products Elfabrio and Elelyso. We appreciate all those who have been reached out to Protalix to express their concern and support and we thank you for joining us today. I will now review our recent progress and accomplishments. Following my remarks, Eyal will provide a more detailed review of our financial results and then of course, we will open the line for questions. Let me now turn to our accomplishments this quarter. Since receiving FDA and EMA approval for Elfabrio, our commercial partner, Chiesi has focused on commercial launch in both the United States and the European Union. We are also pleased that Elfabrio has been granted additional regulatory approvals outside the EU, like in Great Britain and Switzerland, and we look forward to continued global growth of Elfabrio.

Having now secured the approval of two drug products, Elfabrio and Elelyso, we are now focusing our attention to develop our pipeline assets with the potential to address high unmet needs for patients with limited therapeutic options. Our most advanced development candidate is PRX-115 for the potential treatment of severe gout. We are currently sponsoring a Phase 1 first in human clinical trial of PRX-115 to evaluate its safety, pharmacokinetics, pharmacodynamics and immunogenicity. It is a double-blind, placebo-controlled single ascending dose trial of up to 56 participants. 42 participants have been dosed today in this first in human trial. We expect to announce topline results from this study in mid-2024. We believe PRX-115 is potentially a good candidate to target this market.

Our next pipeline candidate is PRX-119 for the potential treatment of NETs-related diseases. NETs are web like structures released by activated neutrophils that trap and kill a variety of microorganisms. Excessive formation or ineffective clearance of NETs can result in different pathological effects and has been observed in various autoimmune inflammatory and fibrotic conditions. We look forward to providing with updates on these programs as they progress. There are currently several other preclinical programs and we will update regarding these programs once applicable. On the corporate side, we welcome Dr. Eliot Forster, as Chairman of our Board of Directors, succeeding Mr. Zeev Bronfeld, who retired from his position on our board. As an independent director, Dr. Forster was also appointed to our nominating committee.

Eliot's reputation in management and leadership in the life science field speaks for itself, and he has a record of success in the United States, the European Union and Asia. We are grateful to Zeev for his dedication and leadership since the founding of Protalix many, many years ago, and we look forward to working with Eliot and leveraging his expertise as we enter this exciting phase of development for this company. Before turning the call to over to Eyal, I want to know that our strong balance sheet provides us with sufficient cash runway to maintain current operations without the need for near-term capital infusion. With that, it is now my pleasure to turn the call over to Eyal to review our financials. Eyal, please.

Eyal Rubin: Thank you, Dror. And thank you everyone for joining today's call. Let me review our third quarter 2023 financials. We recorded revenues from selling goods of $10.2 million during the three months ended September 30th, 2023, an increase of $1.4 million or 16% compared to revenues of $8.8 million for the three months ended September 30th, 2022. The increase resulted primarily from an increase of $3 million in sales to Chiesi, following the approval by the FDA and the EMA, as Dror mentioned, of Elfabrio, and of $0.6 million in sales to Brazil, partially offset by $2.2 million decrease in sales to Pfizer. Recorded revenues from license and R&D services of $0.2 million for the three months ended September 30th, 2023, a decrease of $5.2 million, or 96%, compared to revenues of $5.4 million for the three months ended September 30, 2022.

Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the Chiesi Agreements. As of March 1st, 2023, sponsorship of the extension studies was transferred to Chiesi, and Chiesi is now administering all open label extension studies. Cost of goods sold was $4.9 million for the three months ended September 30th, 2023, a decrease of $2.2 million, or 31%, from cost of goods sold of $7.1 million for the three months ended September 30th, 2022. The decrease in cost of goods sold was primarily the result of the decrease in sales to Pfizer, partially offset by an increase in sales of Elfabrio to Chiesi and of Elelyso to Brazil. For the three months ended September 30th, 2023, our total research and development expenses were approximately $3.7 million comprised of approximately $1 million of subcontractor-related expenses, approximately $1.9 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.6 million of other expenses.

For the three months ended September 30th, 2022, our total research and development expenses were approximately $7.4 million comprised of approximately $4.9 million in subcontractor-related expenses, approximately $1.7 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.6 million of other expenses. Total decrease in research and developments expenses was $3.7 million, or 50%, compared to the three months ended September 30th, 2022. The decrease in research and development expenses primarily resulted from the completion of our Fabry clinical program and the regulatory processes related to the BLA and MAA review of Elfabrio by the applicable regulatory agencies. Selling, general and administrative expenses were $3.7 million for the three months ended September 30, 2023, an increase of $0.9 million, or 32%, compared to $2.8 million for the three months ended September 30th, 2022.

The increase resulted primarily from an increase of approximately $0.6 million in salary and related expenses due to one-time cash bonuses and an increase in share-based compensation. Financial income, net was $0.2 million for the three months ended September 30, 2023, compared to financial expenses, net of $0.4 million for the three months ended September 30, 2022. The change resulted primarily from an increase of $0.3 million in interest income. In the three months ended September 30, 2023, we recorded income taxes of approximately $0.1 million which were primarily the result of the provision for current taxes in respect of Section 174 of the U.S. Tax Cuts and Jobs Act, which was enacted in December 2017. Cash, cash equivalents and short term bank deposits were approximately $41 million at September 30th, 2023.

Net loss for the three months ended September 30th, 2023 was approximately $1.9 million, or $0.03 per share, basic, and $0.04 per share diluted, compared to a net loss of $3.6 million, or $0.07 per share, basic and diluted, for the same period in 2022. I will now turn the call back to you, Dror.

Dror Bashan: Thank you, Eyal. In concluding this earnings call, I would like to know that we at Protalix are proud of our accomplishments. We have a proven platform technology with two approved therapeutics driving a rich and sustainable pipeline of assets. A worldclass team, a strong balance sheet supporting our strategic plans and a strategic vision to creating a long-term value for our stockholders. We look forward to updating you in the future in our progress. Before we start taking questions, I would like to note that we are praying for our friends and family during this challenging time. One that is filled with pain. I'm grateful for our entire Protalix team, their enduring commitment and resolve at this time as we develop a portfolio for patients with unmet medical needs is noteworthy. Now I would like to ask the operator to open the call for questions, please.

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