Protalix BioTherapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Protalix BioTherapeutics, Inc. has filed its 2023 10-K annual report detailing its financial performance and business operations.</b>

AI Summary

Protalix BioTherapeutics, Inc. (PLX) filed a Annual Report (10-K) with the SEC on March 14, 2024. Protalix BioTherapeutics, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal business address is located at 2 University Plaza, Suite 100, Hackensack, NJ 07601. Protalix BioTherapeutics, Inc. is classified under SIC code 2836 for Biological Products (No Diagnostic Substances). The report includes details on employee stock options with various exercise prices and restricted stock grants.

Why It Matters

For investors and stakeholders tracking Protalix BioTherapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Protalix BioTherapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed information on stock options and restricted shares offers insight into the company's executive compensation structure and its strategy for incentivizing employees and management.

Risk Assessment

Risk Level: — Protalix BioTherapeutics, Inc. shows moderate risk based on this filing. The company operates in the highly regulated biotechnology sector, facing risks related to drug development, clinical trials, regulatory approvals, and market competition, as evidenced by the nature of its business and industry.

Analyst Insight

Investors should review the full 10-K filing to understand Protalix BioTherapeutics' financial position, operational risks, and strategic initiatives for 2024.

Key Numbers

• 72,952,124 — Total Assets (As of December 31, 2023)

Key Players & Entities

• Protalix BioTherapeutics, Inc. (company) — Filer name
• 2 University Plaza, Suite 100, Hackensack, NJ 07601 (address) — Business address
• 2836 (SIC code) — Standard Industrial Classification
• 2023-12-31 (date) — Fiscal year end

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the FDA, which can impact product development, manufacturing, and marketing.
• Market Competition [high — market]: The biotechnology market is highly competitive, with potential for new entrants and existing competitors developing superior products or technologies.
• Financing Risks [medium — financial]: The company may require additional financing to fund its operations and development activities, and there is no assurance that such financing will be available on favorable terms.

Industry Context

Protalix BioTherapeutics operates in the biopharmaceutical industry, focusing on the development and commercialization of protein-based therapeutics. This sector is characterized by long development cycles, high R&D costs, and significant regulatory hurdles.

Regulatory Implications

The company's operations are subject to stringent regulations by health authorities like the U.S. Food and Drug Administration (FDA) and similar international bodies, governing drug approval, manufacturing, and marketing.

What Investors Should Do

1. Analyze the detailed financial statements and Management's Discussion and Analysis in the 10-K to understand revenue streams, expenses, and profitability trends.
2. Evaluate the company's disclosed risk factors, particularly those related to clinical development, regulatory approvals, and market competition, to assess potential challenges.
3. Examine the information on stock options and equity awards to understand executive compensation and potential dilution effects for shareholders.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-14: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This filing is the annual 10-K report for the fiscal year ended December 31, 2023, providing a comprehensive update compared to previous filings.

Key Financial Figures

• $0.001 — ange on which registered Common stock, $0.001 par value PLX NYSE American Secur
• $12.5 million — Brazilian MoH. In 202 3 , we generated $12.5 million from sales of Elelyso to Pfizer and $10
• $10.4 million — ion from sales of Elelyso to Pfizer and $10.4 million from sales of BioManguinhos alfataligli
• $17.5 million — rland and Israel. In 2023, we generated $17.5 million from sales of Elfabrio to Chiesi. Pro

Filing Documents

• plx-20231231x10k.htm (10-K) — 2341KB
• plx-20231231xex4d7.htm (EX-4.7) — 18KB
• plx-20231231xex23d1.htm (EX-23.1) — 8KB
• plx-20231231xex31d1.htm (EX-31.1) — 11KB
• plx-20231231xex31d2.htm (EX-31.2) — 11KB
• plx-20231231xex32d1.htm (EX-32.1) — 6KB
• plx-20231231xex32d2.htm (EX-32.2) — 5KB
• plx-20231231xex97d1.htm (EX-97.1) — 46KB
• plx-20231231x10k001.jpg (GRAPHIC) — 38KB
• plx-20231231x10k002.jpg (GRAPHIC) — 44KB
• plx-20231231x10k003.jpg (GRAPHIC) — 53KB
• plx-20231231x10k004.jpg (GRAPHIC) — 48KB
• plx-20231231x10k005.jpg (GRAPHIC) — 38KB
• plx-20231231x10k007.jpg (GRAPHIC) — 3KB
• plx-20231231xex23d1001.jpg (GRAPHIC) — 5KB
• 0001558370-24-003161.txt (&nbsp;) — 9885KB
• plx-20231231.xsd (EX-101.SCH) — 66KB
• plx-20231231_cal.xml (EX-101.CAL) — 64KB
• plx-20231231_def.xml (EX-101.DEF) — 270KB
• plx-20231231_lab.xml (EX-101.LAB) — 472KB
• plx-20231231_pre.xml (EX-101.PRE) — 455KB
• plx-20231231x10k_htm.xml (XML) — 1456KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 33 Item 1B. Unresolved Staff Comments 59 Item 1C. Cybersecurity 59 Item 2.

Properties

Properties 61 Item 3.

Legal Proceedings

Legal Proceedings 61 Item 4. Mine Safety Disclosures 61 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 62 Item 6. [Reserved] 62 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 63 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 74 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 74 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 74 Item 9A.

Controls and Procedures

Controls and Procedures 74 Item 9B. Other Information 76 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 76 PART III Item 10. Directors, Executive Officers and Corporate Governance 77 Item 11.

Executive Compensation

Executive Compensation 77 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 77 Item 13. Certain Relationships and Related Transactions, and Director Independence 77 Item 14. Principal Accountant Fees and Services 77 PART IV Item 15. Exhibits and Financial Statement Schedules 78 Item 16. Form 10-K Summary 82

Signatures

Signatures 83 Table of Contents PART I Except where the context otherwise requires, the terms "we," "us," "our" or "the Company," refer to the business of Protalix BioTherapeutics, Inc. and its consolidated subsidiaries, and "Protalix" or "Protalix Ltd." refers to the business of Protalix Ltd., our wholly-owned subsidiary and sole operating unit. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS The statements set forth under the sections entitled "Business," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors," and other statements included elsewhere in this Annual Report on Form 10-K, particularly with respect to our plans and strategy for our business and related financing, include forward-looking statements within the meanings of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, including statements regarding expectations, beliefs, intentions or strategies for the future. When used in this report, the terms "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" and other words or phrases of similar import, as they relate to our company, our subsidiaries or our management, are intended to identify forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance, and we undertake no obligation to update or revise, nor do we have a policy of updating or revising, any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unantic

Business

Item 1. Business We are a commercial stage biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced via our proprietary ProCellEx plant cell-based protein expression system. We are the first and only company to gain FDA approval of a protein produced through plant cell-based expression in suspension. Our unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. To date, we have successfully developed two commercial products. On May 5, 2023, the European Commission, or EC, announced that it had approved the Marketing Authorization Application, or MAA, for Elfabrio and on May 9, 2023, the FDA announced that it had approved the Biologics License Application, or BLA, for Elfabrio (pegunigalsidase alfa-iwxj) injection BLA 761161, each for adult patients with a confirmed diagnosis of Fabry disease. Both approvals cover the 1 mg/kg every two weeks dosage. Elfabrio was approved by the FDA with a boxed warning for hypersensitivity reactions/anaphylaxis, consistent with Enzyme Replacement Therapy (ERT) class labeling, and Warnings/Precautions providing guidance on the signs and symptoms of hypersensitivity and infusion-associated reactions seen in the clinical studies as well as treatments to manage such events should they occur. The Warnings/Precautions for membranoproliferative glomerulonephritis (MPGN) alert prescribers to the possibility of MPGN and provide guidance for appropriate patient management. Overall, the FDA review team concluded that in the context of Fabry disease as a rare, serious disease with limited therapeutic options that may not be suitable to all individual patients, the benefit-risk of Elfabrio is favorable for the treatment of adults with confirmed Fabry disease. According to the EMA, overall, the benefit/risk balance of Elfabrio is positive in the claimed indication (Fabry disease). Elfabrio has also been approved f

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View this 10-K filing on SEC EDGAR