CollPlant Biotechnologies Ltd. Files 20-F Annual Report for Fiscal Year Ended Dec 31, 2023

TL;DR

<b>CollPlant Biotechnologies Ltd. filed its annual 20-F report detailing its fiscal year 2023 performance and share structure.</b>

AI Summary

CollPlant Biotechnologies Ltd (CLGN) filed a Foreign Annual Report (20-F) with the SEC on April 4, 2024. CollPlant Biotechnologies Ltd. filed its annual report on Form 20-F for the fiscal year ended December 31, 2023. The company's ordinary shares are traded on the Nasdaq Global Market under the symbol CLGN. As of December 31, 2023, CollPlant had 11,452,672 ordinary shares outstanding. The principal executive offices are located at 4 Oppenheimer St., Rehovot, Israel. The filing confirms the company is not a well-known seasoned issuer.

Why It Matters

For investors and stakeholders tracking CollPlant Biotechnologies Ltd, this filing contains several important signals. This filing provides investors with a comprehensive overview of CollPlant's financial health, operational status, and corporate governance for the past fiscal year. The 20-F report is crucial for understanding the company's compliance with SEC regulations and its standing in the public market, particularly for international registrants.

Risk Assessment

Risk Level: low — CollPlant Biotechnologies Ltd shows low risk based on this filing. The filing is a routine annual report and does not contain new material information that would significantly alter the risk profile.

Analyst Insight

Review the full 20-F filing for detailed financial statements, risk factors, and management discussion to assess the company's performance and future outlook.

Key Numbers

• 20231231 — Fiscal Year End (Conformed period of report)
• 20240404 — Filing Date (Filed as of date)
• 11,452,672 — Outstanding Ordinary Shares (As of December 31, 2023)
• NIS 1.50 — Par Value per Ordinary Share (Ordinary shares)

Key Players & Entities

• CollPlant Biotechnologies Ltd. (company) — Registrant name
• CLGN (company) — Trading symbol
• Nasdaq Global Market (company) — Exchange
• Yehiel Tal (person) — Chief Executive Officer
• Israel (company) — Jurisdiction of incorporation and principal executive offices location

FAQ

Industry Context

CollPlant Biotechnologies Ltd. operates in the biotechnology sector, focusing on regenerative medicine and tissue engineering.

Regulatory Implications

As an Israeli company filing with the SEC, CollPlant adheres to US securities regulations, including the annual reporting requirements of Form 20-F.

What Investors Should Do

1. Analyze the financial statements within the 20-F for revenue, expenses, and profitability trends.
2. Review the 'Risk Factors' section for any new or updated risks disclosed by the company.
3. Examine management's discussion and analysis (MD&A) for insights into business strategy and outlook.

Key Dates

• 2023-12-31: Fiscal Year End — Reporting period for the 20-F filing.
• 2024-04-04: Filing Date — Date the 20-F report was submitted to the SEC.

Year-Over-Year Comparison

This is the annual 20-F filing for the fiscal year ended December 31, 2023, providing updated information compared to previous filings.

Key Financial Figures

• $10 million — issue filler product, which triggered a $10 million payment from AbbVie to us. The dermal a
• $7.0 million — incurred a total comprehensive loss of $7.0 million for the year ended December 31, 2023 an
• $16.9 million — 2023 and a total comprehensive loss of $16.9 million for the year ended December 31, 2022. A
• $96.7 million — 2023, we had an accumulated deficit of $96.7 million. We have devoted most of our financial

Filing Documents

• ea0202823-20f_collplant.htm (20-F) — 1919KB
• ea020282301ex4-3_collplant.htm (EX-4.3) — 119KB
• ea020282301ex4-4_collplant.htm (EX-4.4) — 153KB
• ea020282301ex12-1_collplant.htm (EX-12.1) — 10KB
• ea020282301ex12-2_collplant.htm (EX-12.2) — 10KB
• ea020282301ex13-1_collplant.htm (EX-13.1) — 4KB
• ea020282301ex13-2_collplant.htm (EX-13.2) — 4KB
• ea020282301ex15-1_collplant.htm (EX-15.1) — 5KB
• image_001.jpg (GRAPHIC) — 9KB
• image_002.jpg (GRAPHIC) — 21KB
• image_003.jpg (GRAPHIC) — 45KB
• image_004.jpg (GRAPHIC) — 24KB
• fin_001.jpg (GRAPHIC) — 2KB
• ex15-1_001.jpg (GRAPHIC) — 3KB
• 0001213900-24-030055.txt (&nbsp;) — 7124KB
• clgn-20231231.xsd (EX-101.SCH) — 58KB
• clgn-20231231_cal.xml (EX-101.CAL) — 42KB
• clgn-20231231_def.xml (EX-101.DEF) — 254KB
• clgn-20231231_lab.xml (EX-101.LAB) — 510KB
• clgn-20231231_pre.xml (EX-101.PRE) — 270KB
• ea0202823-20f_collplant_htm.xml (XML) — 668KB

Risk Factors

Risk Factors 1 ITEM 4. INFORMATION ON THE COMPANY 44 A. History and Development of the Company 44 B. Business Overview 45 C. Organizational Structure 80 D. Property, Plants and Equipment 80 ITEM 4A. UNRESOLVED STAFF COMMENTS 81 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 81 A. Operating Results 84 B. Liquidity and Capital Resources 86 C. Research and Development, Patents and Licenses 88 D. Trend Information 88 E. Critical Accounting Estimates 88 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 89 A. Directors and Senior Management 89 B. Compensation 92 C. Board Practices 94 D. Employees 105 E. Share Ownership 106 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 108 A. Major Shareholders 108 B. Related Party Transactions 110 C. Interests of Experts and Counsel 112 ITEM 8. FINANCIAL INFORMATION 112 A. Consolidated Statements and Other Financial Information 112 B. Significant Changes 113 i ITEM 9. THE OFFER AND LISTING 113 A. Offer and Listing Details 113 B. Plan of Distribution 113 C. Markets 113 D. Selling Shareholders 113 E.

Dilution

Dilution 113 F. Expenses of the Issue 113 ITEM 10. ADDITIONAL INFORMATION 113 A. Share Capital 113 B. Articles of Association 113 C. Material Contracts 114 D. Exchange Controls 114 E. Taxation 114 F. Dividends and Paying Agents 125 G. 125 H. Documents on Display 125 I. Subsidiary Information 126 ITEM 11.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 126 ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 126 A. Debt Securities 126 B. Warrants and rights 126 C. Other Securities 126 D. American Depositary Shares 126 PART II 127 ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES 127 ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 127 ITEM 15.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 127 ITEM 16. [RESERVED] 128 ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT 128 ITEM 16B. CODE OF ETHICS 128 ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES 128 ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 129 ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 129 ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT 129 ITEM 16G. CORPORATE GOVERNANCE 129 ITEM 16H. MINE SAFETY DISCLOSURE 131 ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 131 ITEM 16J. INSIDER TRADING POLICIES 131 ITEM 16K. CYBERSECURITY 131 PART III 132 ITEM 17.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 132 ITEM 18.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 132 ITEM 19. EXHIBITS 132

SIGNATURES

SIGNATURES 134 ii INTRODUCTION We are a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. Our products are based on our recombinant human collagen (rhCollagen) produced with our proprietary plant based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine. In February 2021, we entered into a development and global commercialization agreement with Allergan, an AbbVie company, or the AbbVie Development Agreement, pursuant to which we and AbbVie are collaborating in the development and commercialization of dermal and soft tissue filler products for the medical aesthetics market, using our rhCollagen technology and AbbVie's technology. In June 2023, we announced the achievement of a milestone with respect to the clinical phase dermal and soft tissue filler product, which triggered a $10 million payment from AbbVie to us. The dermal and soft tissue filler product candidate is currently undergoing testing in clinical trials, which trials are designed, planned, and executed by AbbVie, in accordance with the AbbVie Development Agreement. In the field of medical aesthetics, we are developing 3D-bioprinted breast implants for regeneration of breast tissue. The implants in development are printed and loaded with our rhCollagen-based bioink in combination with other proprietary biomaterials. These implants are expected to regenerate breast tissue without eliciting immune response, and thus may provide a revolutionary alternative for aesthetic and reconstructive procedures. In December 2023 we initiated a pre-clinical trial to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. This study will be used to obtain data to support subsequent human studies and future product commercialization. In January 2023, we commercially launche

Forward-looking statements

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things: our history of significant losses, and our need to raise additional capital and our inability to obtain additional capital on acceptable terms, or at all; our expectations regarding the timing and cost of commencing pre-clinical and clinical trials with respect to rhCollagen based products in 3D bioprinting and medical aesthetics; ours or our strategic partners' ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to rhCollagen based products in 3D bioprinting and medical aesthetics, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of rhCollagen based products in 3D bioprinting and medical aesthetics; our ability to establish sales and marketing capabilities or enter into agreements with third parties and our reliance on third party distributors and resellers; our ability to establish and maintain strategic partnerships and other corporate collaborations; iv our reliance on third parties to conduct some or all aspects of our product manufacturing; the scope of protection we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; cur

IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable.

OFFER STATISTICS AND EXPECTED TIMETABLE

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable.

KEY INFORMATION

ITEM 3. KEY INFORMATION A. Reserved. B. Capitalization and Indebtedness Not applicable. C. Reasons for the Offer and Use of Proceeds Not applicable. D. Risk Factors You should carefully consider the risks described below, together with all of the other information in this Annual Report on Form 20-F. The risks and uncertainties described below are those significant risk factors, currently known and specific to us, that we believe are relevant to an investment in our securities. Additional risks and uncertainties not currently known to us or that we now deem immaterial may also harm us. If any of these risks materialize, our business, results of operations or financial condition could suffer, and the price of our ordinary shares could decline substantially. Summary Risk Factors Investing in our ordinary shares involves a high degree of risk, as fully described below. The principal factors and uncertainties that make investing in our ordinary shares risky, include, among others: Risks Related to Our Financial Position and Capital Requirements We have generally incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain additional capital when needed may force us to delay, limit, or terminate our product development efforts or other operations. 1 Risks Related to Commercialization of Our Products The commercial success of any current or future product, if approved, will depend upon the degree of market acceptance by physicians, patients, third-party payors, pharma companies and others in the medical community. We have only limited clinical data to support sales of our products, which may make physicians, patients, third-party payors, and others in the medical community reluctant to accept or purchase our products. We have low scale experience in producing o

View Full Filing

View this 20-F filing on SEC EDGAR