Iterum Therapeutics plc (NASDAQ:ITRM) Q3 2021 Earnings Conference Call November 12, 2021 8:30 AM ET Company Participants Corey Fishman – CEO Louise Barrett – Senior Vice President Legal Affairs Judy Matthews – CFO Conference Call Participants Gregory Renza – RBC Capital Markets Thomas Yip – H.C. Wainwright Operator Hello and welcome to the Iterum Therapeutic Q3 Financial Results Conference Call. My name is Alex and I will be your operator for today. [Operator Instructions] I'll now hand over to your host, L ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) WASHINGTON, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 For the transition period from to OR Commission File Number: 001-38503 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) Ireland 98-1283148 (State or other juris ...

Iterum Therapeutics plc (NASDAQ:ITRM) Q2 2021 Earnings Conference Call August 13, 2021 8:30 AM ET Company Participants Louise Barrett - Senior Vice President of Legal Affairs Corey Fishman - Chief Executive Officer Judy Matthews - Chief Financial Officer Conference Call Participants Gregory Renza - RBC Capital Markets Operator Hello and welcome to Iterum Therapeutics Q2 Financial Results Conference Call. Please note that all lines are currently on listen-only mode. [Operator Instructions] I now have the ple ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

Iterum Therapeutics plc (NASDAQ:ITRM) Q1 2021 Earnings Conference Call May 14, 2021 8:30 AM ET Company Participants Louise Barrett - Senior Vice President of Legal Affairs Corey Fishman - Chief Executive Officer Judy Matthews - Chief Financial Officer Conference Call Participants Gregory Renza - RBC Capital Markets Ed Arce - H.C. Wainwright Kevin Kedra - G Research Operator Ladies and gentlemen, welcome to the Iterum Therapeutics First Quarter 2021 Financial Results Conference Call. My name is Katie and I' ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38503 Iterum Therapeutics plc WASHINGTON, DC 20549 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporatio ...

ITherapeutics ERUM Company Overview April 2021 Oral and IV treatment for serious bacterial infections ERUM 1 ITherapeutics Forward-looking Statements & Disclaimer This presentation contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, the sufficiency of cash resources, the granting or issuing of patents, the expected timing of NDA and EMA filings and our plans, strategies and pro ...

Financial Data and Key Metrics Changes - R&D costs for Q4 2020 were $2.4 million, a significant decrease from $20.9 million in Q4 2019, primarily due to the completion of enrollment in the Phase 3 program in 2019 [38] - Full year R&D costs were $21.1 million in 2020 compared to $90.8 million in 2019, reflecting the same trend [38] - G&A costs remained stable at $2.3 million for Q4 2020, with a slight decrease in full year G&A costs to $11.1 million from $11.3 million in 2019 [39] - Interest expense increased to $4.2 million in Q4 2020 from $400,000 in 2019, with full-year interest expense at $15.1 million compared to $900,000 in 2019, largely due to non-cash interest related to financing [40][41] - Cash on hand at the end of 2020 was $14.5 million, with subsequent equity financings raising over $74 million in February 2021, resulting in over $100 million in cash as of February 2021 [42] Business Line Data and Key Metrics Changes - The primary focus is on the lead drug candidate, oral sulopenem, which is under FDA review for treating uncomplicated urinary tract infections [9][16] - The Phase 3 study for oral sulopenem showed statistical superiority to ciprofloxacin, with a p-value less than 0.001 for patients with quinolone non-susceptible pathogens [10] - The addressable market for oral sulopenem in the U.S. is estimated at 6.5 million infections annually for the initial indication, with potential expansion to 22 million infections for the entire uncomplicated urinary tract infection market [17] Market Data and Key Metrics Changes - The market for uncomplicated urinary tract infections is substantial, with over 22 million infections annually in the U.S. [17] - The competitive landscape indicates that sulopenem would be the first new branded oral product in this space in over 20 years, with only two other similar products under development [26] Company Strategy and Development Direction - The company plans to implement a highly targeted commercialization strategy, focusing on areas with high resistance rates and physician prescribing patterns [22][23] - A partnership with EVERSANA has been established for prelaunch activities, including healthcare provider awareness campaigns and payer discussions [18][20] - The company aims to expand indications for sulopenem, starting with complicated urinary tract infections, which have about 3.5 million infections annually in the U.S. [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the robust data package for oral sulopenem and the potential for approval, despite challenges related to asymptomatic bacteriuria [52][59] - The company anticipates sufficient cash to support operations and pre-launch activities into 2023, allowing for a potential launch of sulopenem in Q4 2021 [34][42] Other Important Information - The company has a strong intellectual property position, with patents for sulopenem expiring in 2029, potentially extendable to 2034 [14] - The FDA has granted sulopenem the qualified infectious disease product designation, providing expedited review and additional regulatory exclusivity [15] Q&A Session Summary Question: Context on Ad Com preparations and FDA feedback - Management indicated that the review process has been standard, with no significant issues flagged by the FDA, and expressed confidence in the data package [52] Question: Developments around tablet manufacturing for sulopenem - Management noted ongoing discussions with the FDA regarding data requests from manufacturers, with no indications of delays [54] Question: Addressing asymptomatic bacteriuria concerns during Ad Com - Management emphasized the clinical practice perspective, stating that asymptomatic bacteriuria is not a significant issue for patient health, and expressed readiness to discuss this at the Ad Com [58][59] Question: Pricing strategy for sulopenem - Management confirmed plans for a formal pricing study closer to launch, with an estimated price range of $150 to $200 per day [60] Question: Stewardship concerns regarding antibiotic use - Management aligned with stewardship principles, emphasizing the appropriate use of sulopenem for high-risk patients and those with quinolone-resistant pathogens [68][70] Question: Changes in FDA interactions since filing acceptance - Management reported no significant changes in tone or interactions with the FDA, maintaining a standard review process [73] Question: Cash runway and expansion opportunities - Management confirmed that the cash runway includes funding for potential trials related to complicated urinary tract infections and other indications [74]

PART I [Business](index=7&type=section&id=Item%201.%20Business) Iterum Therapeutics is a clinical-stage pharmaceutical company focused on developing sulopenem, a novel anti-infective for multi-drug resistant infections, with an NDA for oral sulopenem for uUTIs accepted for priority review - The company's primary focus is the development and commercialization of sulopenem, a penem antibiotic with both oral (sulopenem etzadroxil-probenecid) and IV formulations, targeting urinary tract and intra-abdominal infections[21](index=21&type=chunk) - An NDA for oral sulopenem for the treatment of uUTIs in patients with a quinolone non-susceptible pathogen was submitted in Q4 2020 and accepted for priority review by the FDA in January 2021, with a PDUFA goal date of July 25, 2021, and an advisory committee meeting planned for June 2, 2021[23](index=23&type=chunk)[35](index=35&type=chunk) Phase 3 Trial Primary Endpoint Results | Trial | Indication | Comparator | Primary Endpoint Met? | | :--- | :--- | :--- | :--- | | SURE 1 | uUTI (Quinolone-Resistant) | Ciprofloxacin | Yes (Superiority) | | SURE 1 | uUTI (Quinolone-Susceptible) | Ciprofloxacin | No (Non-inferiority) | | SURE 2 | cUTI | Ertapenem / Ciprofloxacin | No (Non-inferiority) | | SURE 3 | cIAI | Ertapenem / Ciprofloxacin+Metronidazole | No (Non-inferiority) | - The company operates under an exclusive worldwide license from Pfizer for patents and know-how related to sulopenem, which includes milestone and royalty payment obligations[24](index=24&type=chunk)[118](index=118&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks, including a history of net losses, dependence on the success of the sulopenem program, and the need for additional capital - The company has a history of net losses, with an accumulated deficit of **$286.9 million** as of December 31, 2020, and anticipates continued losses unless sulopenem is successfully commercialized[19](index=19&type=chunk)[217](index=217&type=chunk) - The business is heavily dependent on the success of the sulopenem program, and failure to obtain marketing approval for oral sulopenem would materially harm the business[19](index=19&type=chunk)[227](index=227&type=chunk)[250](index=250&type=chunk) - Additional capital will be required to fund operations, with existing cash and recent financing estimated to fund operations into the first half of 2023, based on assumptions that may prove wrong[220](index=220&type=chunk)[221](index=221&type=chunk) - The company relies on an exclusive license agreement with Pfizer, and failure to comply with obligations could result in the loss of rights essential to the business[19](index=19&type=chunk)[310](index=310&type=chunk) - The COVID-19 pandemic poses risks that could delay clinical trials, disrupt regulatory activities, and adversely affect business operations and access to financial markets[19](index=19&type=chunk)[422](index=422&type=chunk) [Properties](index=90&type=section&id=Item%202.%20Properties) The company leases office space for its headquarters in Dublin, Ireland, and additional offices in Connecticut and Illinois, with the Dublin headquarters lease terminated effective November 2021 - Headquarters are located in Dublin, Ireland, with a lease extending through November 2026; however, the company exercised its option to terminate this lease in November 2020, making it effective through November 2021[487](index=487&type=chunk) - The company also leases office space in Old Saybrook, CT (through June 2022) and Chicago, IL (through June 2023)[489](index=489&type=chunk)[490](index=490&type=chunk) [Legal Proceedings](index=91&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, the company is not a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any material legal proceedings[491](index=491&type=chunk) PART II [Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities](index=92&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Shareholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's ordinary shares trade on The Nasdaq Capital Market under "ITRM" after a December 2020 transfer, with no cash dividends ever paid or anticipated, and several unregistered securities issued in 2020 - The company's ordinary shares were transferred from The Nasdaq Global Market to The Nasdaq Capital Market on December 23, 2020, trading under the symbol "ITRM"[495](index=495&type=chunk) - No cash dividends have ever been declared or paid, and none are anticipated in the foreseeable future[497](index=497&type=chunk) - In 2020, the company issued unregistered securities, including Exchangeable Senior Subordinated Notes, Royalty-Linked Subordinated Notes, and various warrants to investors and placement agents in connection with financing activities[498](index=498&type=chunk)[499](index=499&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=94&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2020, the company's net loss decreased to $52.0 million from $103.1 million in 2019, driven by reduced R&D expenses, partially offset by increased other expenses, with current cash sufficient to fund operations into the first half of 2023 Results of Operations (2020 vs. 2019, In thousands) | (In thousands) | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $0 | $37 | ($37) | | **Research and development** | $21,074 | $90,774 | ($69,700) | | **General and administrative** | $11,052 | $11,284 | ($232) | | **Operating loss** | ($32,126) | ($102,021) | $69,895 | | **Total other expense** | ($19,137) | ($665) | ($18,472) | | **Net loss** | ($52,006) | ($103,130) | $51,124 | - The significant decrease in R&D expenses in 2020 was primarily due to the completion of enrollment for the three Phase 3 clinical trials in the second half of 2019[561](index=561&type=chunk) - The increase in total other expense was driven by **$14.2 million** in higher net interest expense related to the Exchangeable Notes and RLNs issued in January 2020, along with costs and fair value adjustments related to these financing transactions[563](index=563&type=chunk)[564](index=564&type=chunk) - As of December 31, 2020, the company had **$14.8 million** in cash, cash equivalents, and restricted cash, with subsequent financing in February 2021 providing aggregate net proceeds of approximately **$74.3 million**, which management believes is sufficient to fund operations into the first half of 2023[522](index=522&type=chunk)[575](index=575&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=112&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to interest rate risk from its variable-rate credit facility and foreign currency exchange risk from global contracts, neither of which is currently considered material or hedged - The primary market risk is interest rate risk associated with the secured credit facility from SVB, which has a variable interest rate, where a **100 basis point** change would have impacted net interest expense by approximately **$40,000** in fiscal year 2020[609](index=609&type=chunk) - The company has foreign currency exchange rate risk from contracts with global CROs and CMOs, but as of year-end 2020, substantially all liabilities were denominated in U.S. dollars, and the impact of currency fluctuations was not material[610](index=610&type=chunk) [Financial Statements and Supplementary Data](index=113&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The audited consolidated financial statements for 2020 report a net loss of $52.0 million, with cash and cash equivalents of $14.5 million, total assets of $32.8 million, total liabilities of $83.4 million, and a total shareholders' deficit of $50.6 million, receiving an unqualified opinion from KPMG Consolidated Balance Sheet Highlights (as of Dec 31, 2020, In thousands) | (In thousands) | Amount | | :--- | :--- | | Cash and cash equivalents | $14,508 | | Total current assets | $21,472 | | **Total assets** | **$32,792** | | Total current liabilities | $41,698 | | **Total liabilities** | **$83,351** | | **Total shareholders' deficit** | **($50,559)** | Consolidated Statement of Operations Highlights (Year ended Dec 31, 2020, In thousands) | (In thousands) | Amount | | :--- | :--- | | Revenue | $0 | | Research and development expenses | ($21,074) | | General and administrative expenses | ($11,052) | | Operating loss | ($32,126) | | **Net loss** | **($52,006)** | | **Net loss per share** | **($2.17)** | Consolidated Statement of Cash Flows Highlights (Year ended Dec 31, 2020, In thousands) | (In thousands) | Amount | | :--- | :--- | | Net cash used in operating activities | ($54,528) | | Net cash used in investing activities | ($11) | | Net cash provided by financing activities | $64,475 | | **Net increase in cash** | **$9,925** | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=149&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There were no changes in or disagreements with the company's accountants on accounting and financial disclosure during the reporting period - None[817](index=817&type=chunk) [Controls and Procedures](index=149&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2020, with no material changes reported during the year - Management evaluated disclosure controls and procedures and concluded they were effective as of December 31, 2020[818](index=818&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2020, based on the 2013 COSO framework[820](index=820&type=chunk) - As an emerging growth company, an attestation report on internal control from the independent registered public accounting firm is not required[821](index=821&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=150&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's 2021 Proxy Statement - The required information is incorporated by reference from the company's 2021 Proxy Statement[825](index=825&type=chunk) [Executive Compensation](index=150&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's 2021 Proxy Statement - The required information is incorporated by reference from the company's 2021 Proxy Statement[827](index=827&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters](index=150&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Shareholder%20Matters) Information regarding security ownership is incorporated by reference from the company's 2021 Proxy Statement - The required information is incorporated by reference from the company's 2021 Proxy Statement[828](index=828&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=150&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's 2021 Proxy Statement - The required information is incorporated by reference from the company's 2021 Proxy Statement[829](index=829&type=chunk) [Principal Accounting Fees and Services](index=150&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the company's 2021 Proxy Statement - The required information is incorporated by reference from the company's 2021 Proxy Statement[830](index=830&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=151&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the exhibits filed as part of the Annual Report on Form 10-K, including corporate governance documents, material contracts, and certifications - This section contains the index to the consolidated financial statements and notes that all financial statement schedules are omitted as they are not applicable[832](index=832&type=chunk)[833](index=833&type=chunk) - A list of all exhibits filed with the report is provided, including key agreements like the Pfizer license, debt indentures, warrant agreements, and equity incentive plans[834](index=834&type=chunk)[835](index=835&type=chunk)[836](index=836&type=chunk)

ITherapeutics ERUM Company Overview February 2021 Oral and IV treatment for serious bacterial infections ERUM 1 ITherapeutics Forward-looking Statements & Disclaimer This presentation contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, the sufficiency of cash resources, the granting or issuing of patents, the expected timing of NDA and EMA filings and our plans, strategies and ...