Fennec Pharmaceuticals Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Fennec Pharmaceuticals Inc. has filed its 2023 10-K report, detailing its fiscal year operations and corporate information.</b>

AI Summary

FENNEC PHARMACEUTICALS INC. (FENC) filed a Annual Report (10-K) with the SEC on March 29, 2024. Fennec Pharmaceuticals Inc. filed its 2023 Form 10-K on March 29, 2024, reporting on its fiscal year ended December 31, 2023. The company's principal executive offices are located at 68 TW Alexander Drive, Research Triangle Park, NC. Fennec Pharmaceuticals Inc. was formerly known as Fennec Pharmaceuticals, Inc. and Adherex Technologies Inc. The SIC code for Fennec Pharmaceuticals Inc. is 2836, categorized under Biological Products (No Diagnostic Substances). Rostislav Raykov is listed as Chief Executive Officer and Director.

Why It Matters

For investors and stakeholders tracking FENNEC PHARMACEUTICALS INC., this filing contains several important signals. This filing provides a comprehensive overview of Fennec's financial health, operational status, and strategic direction for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's performance, risks, and future prospects in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — FENNEC PHARMACEUTICALS INC. shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to drug development, clinical trials, and market approval, which can significantly impact its financial performance and stock value.

Analyst Insight

Monitor future filings for updates on drug development pipelines, regulatory approvals, and financial performance to assess Fennec's growth potential.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported period)
• 2024-03-29 — Filing Date (Date of submission)
• 2836 — SIC Code (Biological Products (No Diagnostic Substances))
• 001-32295 — SEC File Number (SEC registration number)

Key Players & Entities

• FENNEC PHARMACEUTICALS INC. (company) — Filer name
• FENC (company) — Ticker symbol
• 2024-03-29 (date) — Filing date
• 2023-12-31 (date) — Fiscal year end
• Rostislav Raykov (person) — Chief Executive Officer, Director
• Research Triangle Park (location) — Business address city
• NC (location) — Business address state
• 2836 (industry) — Standard Industrial Classification

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-29: Filing Date — Date the 10-K was officially submitted to the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This filing provides the official annual financial and operational overview of Fennec Pharmaceuticals Inc.)

SIC Code

Standard Industrial Classification code used to classify businesses based on their primary activity. (Indicates Fennec Pharmaceuticals' industry focus on Biological Products.)

Key Financial Figures

• $43 million — ment, Fennec will receive approximately $43 million in upfront consideration and up to appr
• $230 million — t consideration and up to approximately $230 million in additional commercial and regulatory

Filing Documents

• fencf-20231231x10k.htm (10-K) — 2850KB
• fencf-20231231xex4d1.htm (EX-4.1) — 10KB
• fencf-20231231xex10d16.htm (EX-10.16) — 178KB
• fencf-20231231xex23d1.htm (EX-23.1) — 5KB
• fencf-20231231xex31d1.htm (EX-31.1) — 15KB
• fencf-20231231xex31d2.htm (EX-31.2) — 15KB
• fencf-20231231xex32d1.htm (EX-32.1) — 8KB
• fencf-20231231xex99d1.htm (EX-99.1) — 250KB
• fencf-20231231xex97.htm (EX-97) — 20KB
• fencf-20231231xex99d1001.jpg (GRAPHIC) — 2KB
• 0001558370-24-004383.txt (&nbsp;) — 10603KB
• fencf-20231231.xsd (EX-101.SCH) — 63KB
• fencf-20231231_cal.xml (EX-101.CAL) — 47KB
• fencf-20231231_def.xml (EX-101.DEF) — 270KB
• fencf-20231231_lab.xml (EX-101.LAB) — 428KB
• fencf-20231231_pre.xml (EX-101.PRE) — 418KB
• fencf-20231231x10k_htm.xml (XML) — 1791KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 24 Item 1B. Unresolved Staff Comments 63 Item 1C. Cybersecurity 63 Item 2.

Properties

Properties 65 Item 3.

Legal Proceedings

Legal Proceedings 65 Item 4. Mine Safety Disclosures 66 PART II 66 Item 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer's Purchases of Equity Securities 66 Item 6. Reserved 73 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 73 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 81 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 81 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 81 Item 9A.

Controls and Procedures

Controls and Procedures 81 Item 9B. Other Information 83 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 83 PART III 84 Item 10. Directors, Executive Officers and Corporate Governance 84 Item 11.

Executive Compensation

Executive Compensation 87 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 91 Item 13. Certain Relationships and Related Transactions and Director independence 92 Item 14. Principal Accounting Fees and Services 93 PART IV 94 Item 15. Exhibits and Financial Statement Schedules 94 Item 16. Form 10-K Summary 96

SIGNATURES

SIGNATURES 97 Table of Contents PART I You are urged to read this Annual Report on Form 10-K ("Annual Report") in its entirety. This Annual Report contains forward-looking statements that involve risks and uncertainties. Our actual results may differ significantly from the projected results discussed in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those discussed below and in Item 1A, "Risk Factors," and Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations – Caution Concerning Forward-Looking Statements." "We," "our," "ours," "us," "Fennec," or the "Company," when used herein, refers to Fennec Pharmaceuticals Inc., a British Columbia corporation, and its wholly-owned subsidiary, Fennec Pharmaceuticals, Inc., a Delaware corporation.

Forward-Looking Statements

Forward-Looking Statements This Annual Report contains "forward-looking statements", as that term is defined in the Private Securities Litigation Reform Act of 1995. These include statements regarding our expectations, beliefs, plans or objectives for future operations and anticipated results of operations. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, "believes", "anticipates", "proposes", "plans", "expects", "intends", "may", and other similar expressions are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or other achievements to be materially different from any future results, performances or achievements expressed or implied by such forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in the section entitled "Item 1A – Risk Factors" and those discussed in the section entitled "Item 7 – Management's Discussion and Analysis of Financial Condition and Results of Operations – Caution Concerning Forward-Looking Statements." Risk Factors Summary The following is a summary of the principal risks that could adversely affect our business, operations, and financial results. A more thorough discussion of these and other risks follows this summary. Risks Related to Our Business We have a history of significant losses and have generated limited revenue from the sale of products since our inception. We may be required to conduct additional clinical trials for PEDMARK , which would be costly and time-consuming to complete. We may require additional financing to obtain regulatory approval for and commercialize PEDMARK , and a failure to obtain this capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate f

Business

Item 1. Business Overview We are a commercial-stage biopharmaceutical company focused on our only product candidate PEDMARK . On September 20, 2022, we received approval from the FDA for PEDMARK (sodium thiosulfate injection) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors. This approval makes PEDMARK the first and only treatment approved by the FDA in this area of significant unmet medical need. On October 17, 2022, we announced commercial availability of PEDMARK in the United States. Further, PEDMARQSI (PEDMARK brand name outside of U.S.) received European Commission Marketing Authorization in June 2023 and received U.K. approval in October 2023. In March 2024, we announced that we entered into an agreement with Norgine, a leading European specialist pharmaceutical company. This is an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI in Europe, Australia and New Zealand. PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localized, non-metastatic solid tumors. Under the terms of the licensing agreement, Fennec will receive approximately $43 million in upfront consideration and up to approximately $230 million in additional commercial and regulatory milestone payments and double-digit tiered royalties on net sales of PEDMARQSI in the licensed territories up to the mid-twenties. Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations in the licensed territories. We sell our product through an experienced field force including Regional Pediatric Oncology Specialists and medical science liaisons who are helping to educate the medical communities and patients about cisplatin induced ototoxicity and our program

View Full Filing

View this 10-K filing on SEC EDGAR