Iterum Therapeutics(ITRM) - 2020 Q4 - Earnings Call Transcript

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]