Protalix BioTherapeutics Announces Repayment of Outstanding Senior Secured Convertible Promissory Notes

Rhea-AI Summary

Protalix BioTherapeutics (NYSE American: PLX) has announced the full repayment of its 7.50% Senior Secured Convertible Promissory Notes, marking a significant milestone for the company. The repayment was financed entirely with available cash, resulting in Protalix becoming debt-free with no outstanding notes. This move has eliminated the potential equity overhang presented by the notes and strengthened the company's balance sheet.

CEO Dror Bashan highlighted that the company's financial discipline has led to a strong financial position, providing sufficient runway for planned ongoing operations. Protalix, a biopharmaceutical company specializing in recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, had previously relied on convertible notes for financing, with the total outstanding principal amount reaching $78.0 million at its peak.

Positive

• Company has become debt-free by repaying all outstanding convertible notes
• Elimination of potential equity overhang from convertible notes
• Strong balance sheet sufficient to support planned ongoing operations
• Repayment financed entirely with available cash, indicating good liquidity

Negative

• None.

Financial Analyst

Protalix's full repayment of its $78.0 million convertible notes marks a significant financial milestone. This move eliminates the company's debt and removes the potential dilution risk for shareholders. The ability to repay using available cash demonstrates strong liquidity and prudent financial management.

The debt-free status strengthens Protalix's balance sheet, potentially improving its financial flexibility and reducing interest expenses. This could lead to improved profitability and cash flow in the future. However, investors should monitor the company's cash burn rate and revenue growth to ensure long-term sustainability without debt financing.

Overall, this development is positive for Protalix, as it reduces financial risk and may enhance the company's attractiveness to investors and potential partners in the biopharmaceutical industry.

Biotech Industry Analyst

Protalix's debt clearance is a positive indicator for its ProCellEx® platform's potential. As a biopharmaceutical company focused on recombinant therapeutic proteins, maintaining a strong financial position is important for ongoing R&D and commercialization efforts.

The debt-free status could provide Protalix with more flexibility to invest in its pipeline and potentially accelerate the development of new therapies. This financial stability may also make the company more attractive for potential partnerships or collaborations within the industry.

However, it's important to note that while the improved balance sheet is beneficial, the true value driver for Protalix will be the success of its product pipeline and the commercial performance of any approved therapies. Investors should closely monitor clinical trial results and regulatory milestones for a comprehensive assessment of the company's prospects.

Company is debt-free with no outstanding notes

Balance sheet provides sufficient runway for ongoing operations

CARMIEL, Israel, Sept. 3, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: 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, today announced that it has repaid in full all of the outstanding principal and interest payable under its 7.50% Senior Secured Convertible Promissory Notes. The repayment of the convertible notes at maturity was financed entirely with available cash.

"Repayment of our convertible notes is a significant milestone for our company as we are now debt-free and have eliminated the potential equity overhang presented by the notes," said Dror Bashan, Protalix's President and Chief Executive Officer. "Over the last decade, our company has been financed in part through the issuance of convertible notes, the total outstanding principal amount of which reached $78.0 million at its highest. Given this repayment, our financial discipline has resulted in a strong balance sheet that is sufficient to support our planned ongoing operations."

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio^®, was approved by both the FDA and the European Medicines Agency (EMA) in May 2023.

Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio^® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; the possible disruption of our operations due to the war declared by Israel's security cabinet against the Hamas terrorist organization located in the Gaza Strip, the military campaign against the Hezbollah and other terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; risks associated with global conditions and developments such as supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us;  the risk that the results of our clinical trials will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer Inc. and Chiesi Farmaceutici S.p.A.; risks related to the amount and sufficiency of our cash and cash equivalents and short-term bank deposits; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; and risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.

Investor Contact

Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com

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SOURCE Protalix BioTherapeutics, Inc.

FAQ

What did Protalix BioTherapeutics (PLX) announce regarding its debt?

Protalix BioTherapeutics (PLX) announced the full repayment of its 7.50% Senior Secured Convertible Promissory Notes, making the company debt-free with no outstanding notes.

How did Protalix BioTherapeutics (PLX) finance the repayment of its convertible notes?

Protalix BioTherapeutics (PLX) financed the repayment of its convertible notes entirely with available cash.

What is the significance of Protalix BioTherapeutics (PLX) repaying its convertible notes?

The repayment eliminates the potential equity overhang presented by the notes and strengthens the company's balance sheet, providing sufficient runway for planned ongoing operations.

What was the highest total outstanding principal amount of Protalix BioTherapeutics' (PLX) convertible notes?

The total outstanding principal amount of Protalix BioTherapeutics' (PLX) convertible notes reached $78.0 million at its highest.