Iterum Therapeutics Files 2024 10-K

TL;DR

Iterum's 2024 10-K is in. Check financials and risks.

AI Summary

Iterum Therapeutics plc filed its 2024 10-K on February 7, 2025, reporting its financial performance for the fiscal year ending December 31, 2024. The company, focused on pharmaceutical preparations, is based in Dublin, Ireland, with its principal executive offices at 3 Dublin Landings. The filing details its business operations, financial condition, and risk factors, including information related to its stock and executive compensation.

Why It Matters

This filing provides investors and stakeholders with a comprehensive overview of Iterum Therapeutics' financial health and strategic direction for the past fiscal year, crucial for investment decisions.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, Iterum Therapeutics faces inherent risks related to drug development, regulatory approvals, and market competition.

Key Numbers

• 2834 — SIC Code (Standard Industrial Classification for Pharmaceutical Preparations)
• 001-38503 — SEC File Number (Iterum's SEC file number)

Key Players & Entities

• Iterum Therapeutics plc (company) — Filer of the 10-K
• 2024-12-31 (date) — Fiscal year end
• 2025-02-07 (date) — Filing date
• 3 Dublin Landings, Dublin 1, L2, D01 H104 (address) — Principal business address
• Pfizer (company) — Mentioned in relation to a license agreement

FAQ

Key Financial Figures

• $0.01 — on which registered Ordinary Shares, $0.01 par value per share ITRM The Nasdaq
• $24.1 million — oncern. As of December 31, 2024, we had $24.1 million of cash and cash equivalents. Subsequen
• $486.1 million — 2024, we had an accumulated deficit of $486.1 million. We will require additional capital t

Filing Documents

• itrm-20241231.htm (10-K) — 5125KB
• itrm-ex4_20.htm (EX-4.20) — 204KB
• itrm-ex10_22.htm (EX-10.22) — 583KB
• itrm-ex23_1.htm (EX-23.1) — 4KB
• itrm-ex31_1.htm (EX-31.1) — 17KB
• itrm-ex31_2.htm (EX-31.2) — 17KB
• itrm-ex32_1.htm (EX-32.1) — 10KB
• itrm-ex32_2.htm (EX-32.2) — 10KB
• img248307334_0.jpg (GRAPHIC) — 88KB
• img248307334_1.jpg (GRAPHIC) — 1069KB
• img248307334_2.jpg (GRAPHIC) — 148KB
• img248307334_3.jpg (GRAPHIC) — 91KB
• img248307334_4.jpg (GRAPHIC) — 178KB
• img248307334_5.jpg (GRAPHIC) — 132KB
• 0000950170-25-015857.txt ( ) — 22933KB
• itrm-20241231.xsd (EX-101.SCH) — 2093KB
• itrm-20241231_htm.xml (XML) — 3342KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 42 Item 1B. Unresolved Staff Comments 98 Item IC. Cybersecurity 98 Item 2.

Properties

Properties 99 Item 3.

Legal Proceedings

Legal Proceedings 99 Item 4. Mine Safety Disclosures 99 PART II Item 5. Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities 100 Item 6. [Reserved] 100 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 101 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 114 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 115 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 149 Item 9A.

Controls and Procedures

Controls and Procedures 149 Item 9B. Other Information 149 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 150 PART III Item 10. Directors, Executive Officers and Corporate Governance 151 Item 11.

Executive Compensation

Executive Compensation 153 Item 12.

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

Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters 162 Item 13. Certain Relationships and Related Transactions, and Director Independence 164 Item 14. Principal Accounting Fees and Services 167 PART IV Item 15. Exhibits, Financial Statement Schedules 168 Item 16 Form 10-K Summary 173 i SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Annual Report are forward-looking statements. In some cases, you can identify forward-looking statements by words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "seek," "should," "target," "will," "would," or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: our use of cash reserves; our ability to continue as a going concern; the design, initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; our ability to advance product candidates into, and successfully complete, clinical trials; the potential advantages of our product candidates; the timing or likelihood of regulatory filings and approvals; the commercialization of our product candidates, if approved; our manufacturing plans; our sales, marketing and distribution capabilities and strategy; the market opportunity for and the potential market acceptance of ORLYNVAH for uncomplicated urinary tract infections caused by certain designated microorganisms in adult women who have limited or

B usiness

Item 1. B usiness. Overview We are a pharmaceutical company dedicated to maximizing the commercial potential of ORLYNVAH , the first oral branded penem available in the United States and potentially the first and only oral and intravenous (IV) branded penem available globally. Penems, including thiopenems and carbapenems, belong to a class of antibiotics more broadly defined as -lactam antibiotics, the original example of which was penicillin, but which now also includes cephalosporins. Sulopenem is a potent, thiopenem antibiotic delivered intravenously which is active against bacteria that belong to the group of organisms known as gram-negatives and cause urinary tract and intra-abdominal infections. We have developed sulopenem in an oral tablet formulation, sulopenem etzadroxil-probenecid, which we refer to herein as oral sulopenem or ORLYNVAH, as the context so requires. We refer to sulopenem delivered intravenously as sulopenem and, sulopenem together with oral sulopenem/ORLYNVAH, as our sulopenem program. We believe that sulopenem and ORLYNVAH have the potential to be important new treatment alternatives to address growing concerns related to antibacterial resistance without the known toxicities of some of the most widely used antibiotics, specifically fluoroquinolones. We exclusively license from Pfizer Inc. (Pfizer) two U.S. patents and three foreign patents, including one U.S. patent directed to composition of matter of sulopenem etzadroxil, which is projected to expire in 2029, subject to potential extension under the Drug Price Competition and Patent Term Restoration Act of 1984, (Hatch-Waxman Act), to 2034, and three foreign patents related to sulopenem etzadroxil. We own four U.S. patents, one Japanese patent, one Korean patent and one Australian patent, with one U.S. patent, the Japanese patent, the Korean patent and the Australian patent directed to the composition of the bilayer tablet of oral sulopenem and its related preparations and/or uses.

View Full Filing

View this 10-K filing on SEC EDGAR