Iterum Therapeutics plc
Business
Iterum Therapeutics plc is a pharmaceutical company focused on developing and maximizing the commercial potential of ORLYNVAH™ and its sulopenem program, an oral and intravenous penem antibiotic for resistant gram-negative infections. Its main products and services center on ORLYNVAH™ (sulopenem etzadroxil with probenecid) as the oral formulation and an IV sulopenem formulation, supported by clinical development, regulatory filings and manufacturing programs. The company operates development, regulatory and potential commercialization efforts, including strategic partnering or direct launch plans. It targets the U.S. market following FDA approval and evaluates regulatory submissions and commercial options in Europe and other global markets, serving community and hospital distribution channels via third-party manufacturers and partners.
Summary from filing dated 2025-02-07
Financials
Consolidated Statement of Income
| Concept | Trend | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 | FY 2020 2020-12-31 |
|---|---|---|---|---|---|---|
| Cost of sales | −254,000 | — | — | — | — | |
| Research and development | −10 | −40 | −18 | −11 | −21 | |
| General and administrative | −8 | −7 | −13 | −14 | −11 | |
| Total operating expenses | −19 | −47 | −30 | −25 | −32 | |
| Operating loss | −19 | −47 | −30 | −25 | −32 | |
| Interest expense, net | −3 | −1 | −2 | −6 | −15 | |
| Adjustments to fair value of derivatives | −3 | 11 | 5 | −61 | −2 | |
| Cancellation of share options | — | — | −17 | — | — | |
| Other (expense) / income, net | −47,000 | 82,000 | 503,000 | 195,000 | 213,000 | |
| Total other (expense) / income | −6 | 10 | −14 | −66 | −19 | |
| Loss before income taxes | −25 | −38 | −44 | −91 | −51 | |
| Income tax expense | −240,000 | −613,000 | −301,000 | −705,000 | −743,000 | |
| Net loss | −25 | −38 | −44 | −92 | −52 | |
| Net loss per share - basic | −1.26 | −2.96 | −3.63 | −8.41 | −32.49 | |
| Net loss per share - diluted | −1.26 | −2.96 | −3.63 | −8.41 | −32.49 | |
| Weighted average ordinary shares outstanding - basic | 20 | 13 | 12 | 11 | 2 | |
| Weighted average ordinary shares outstanding - diluted | 20 | 13 | 12 | 11 | 2 | |
| Unrealized (loss) / income on marketable securities | −1,000 | 351,000 | −350,000 | — | — | |
| Comprehensive loss | −25 | −38 | −45 | −92 | −52 |
Consolidated Balance Sheet
| Concept | Trend | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 | FY 2020 2020-12-31 |
|---|---|---|---|---|---|---|
| Cash and cash equivalents | 24 | 6 | 21 | 27 | 15 | |
| Short-term investments | 0 | 18 | 40 | 54 | 0 | |
| Prepaid expenses and other current assets | 614,000 | 2 | 1 | 2 | 7 | |
| Income taxes receivable | 48,000 | 38,000 | 302,000 | — | — | |
| Total current assets | 25 | 26 | 62 | 83 | 21 | |
| Intangible asset, net | 20 | — | 2 | 3 | — | |
| Property and equipment, net | 23,000 | 51,000 | 69,000 | 91,000 | 421,000 | |
| Restricted cash | 34,000 | 34,000 | 34,000 | 64,000 | 248,000 | |
| Other assets | 5,000 | 578,000 | 3 | 5 | 11 | |
| Total assets | 45 | 26 | 67 | 92 | 33 | |
| Accounts payable | 251,000 | 5 | 3 | 878,000 | 816,000 | |
| Accrued expenses | 3 | 8 | 4 | 1 | 2 | |
| Exchangeable notes | 14 | — | — | — | — | |
| Other current liabilities | 240,000 | 761,000 | 2 | 3 | 4 | |
| Total current liabilities | 18 | 14 | 9 | 13 | 42 | |
| Long-term debt - Exchangeable notes | — | 11 | — | — | — | |
| Long-term debt - Pfizer Promissory Note | 20 | — | — | — | — | |
| Royalty-linked notes | 11 | 8 | 18 | 18 | 13 | |
| Other liabilities | 0 | 188,000 | 1 | 3 | 6 | |
| Total liabilities | 49 | 33 | 39 | 41 | 83 | |
| Commitments and contingencies (Note 16) | — | — | — | — | — | |
| Undesignated preferred shares, $0.01 par value per share: 100,000,000 shares authorized at December 31, 2024 and December 31,2023; no shares issued at December 31, 2024 and December 31, 2023 | — | — | — | — | — | |
| Ordinary shares, $0.01 par value per share: 80,000,000 shares authorized at December 31, 2024 and December 31, 2023, 31,534,233 shares issued at December 31, 2024; 13,499,003 shares issued at December 31, 2023 | 315,000 | 135,000 | 126,000 | 122,000 | 494,000 | |
| Additional paid-in capital | 482 | 455 | 451 | 429 | 236 | |
| Accumulated deficit | −486 | −461 | −423 | −378 | −287 | |
| Accumulated other comprehensive gain | 0 | 1,000 | −350,000 | — | — | |
| Total shareholders' deficit | −4 | −6 | 28 | 50 | −51 | |
| Total liabilities and shareholders' deficit | 45 | 26 | 67 | 92 | 33 |
Consolidated Statement of Cash Flows
| Concept | Trend | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 | FY 2020 2020-12-31 |
|---|---|---|---|---|---|---|
| Net loss | −25 | −38 | −44 | −92 | −52 | |
| Depreciation | 30,000 | 31,000 | 84,000 | 391,000 | 161,000 | |
| Amortization | 254,000 | 2 | 2 | 2 | — | |
| Lease termination adjustments | — | 473,000 | — | — | — | |
| Share-based compensation expense | 363,000 | 784,000 | 5 | 4 | 3 | |
| Amortization of short-term investments | −352,000 | −1 | −183,000 | 636,000 | — | |
| Interest on short-term investments | 1,000 | 55,000 | −55,000 | −290,000 | — | |
| Amortization of debt discount and deferred financing costs | 2 | 2 | 2 | 4 | 11 | |
| Other | 4 | 2 | 2 | 3 | 752,000 | |
| Prepaid expenses and other current assets | −3 | −3 | −2 | 1 | 2 | |
| Other assets | 17,000 | 322,000 | — | −8,000 | 308,000 | |
| Accounts payable | −5 | 2 | 2 | 63,000 | −15 | |
| Accrued expenses | −5 | 3 | 3 | −662,000 | −11 | |
| Income taxes | 155,000 | 271,000 | −510,000 | 271,000 | −120,000 | |
| Other liabilities | −385,000 | −354,000 | −708,000 | −1 | −1 | |
| Net cash used in operating activities | −27 | −39 | −18 | −16 | −55 | |
| Purchases of property and equipment | −2,000 | −13,000 | −62,000 | −61,000 | −11,000 | |
| Purchases of short-term investments | −12 | −41 | −46 | −67 | — | |
| Proceeds from sale of short-term investments | 31 | 65 | 60 | 13 | — | |
| Net cash provided by investing activities | 18 | 23 | 14 | −55 | −11,000 | |
| Repayments of long-term bank debt | — | — | −2 | −7 | −6 | |
| Proceeds from issuance of ordinary shares, net of transaction costs | 27 | 1 | 433,000 | 90 | — | |
| Net cash provided by / (used in) financing activities | 27 | 1 | −2 | 83 | 64 | |
| Effect of exchange rates on cash and cash equivalents | −75,000 | −61,000 | −50,000 | 4,000 | −11,000 | |
| Net increase / (decrease) in cash, cash equivalents and restricted cash | 18 | −15 | −6 | 13 | 10 | |
| Income tax paidU.S. | 220,000 | 401,000 | 821,000 | 435,000 | 120,000 | |
| Interest paid | — | — | 22,000 | 416,000 | 996,000 | |
| Non-cash proceeds - Pfizer Promissory Note | 20 | — | — | — | — |