Iterum Therapeutics (ITRM) Q3 Earnings call transcript Oct 28, 2024

On a groundbreaking morning, Iterum Therapeutics announced the FDA's approval of ORLYNVAH, a new oral sulopenem product designed to tackle uncomplicated urinary tract infections (UTIs) caused by specific bacteria. The approval marks a significant milestone, as this is the first oral penem class drug in the U.S., a class that has only been available intravenously until now. The call, led by Senior Vice President of Legal Affairs, Louise Barrett, was joined by CEO Corey Fishman and Senior Vice President and Head of Clinical Development, Dr. Steven Aronin, who shared insights into the approval, market potential, and ORLYNVAH's label.

A New Era in UTIs: The Market Opportunity for ORLYNVAH

Corey Fishman, CEO of Iterum Therapeutics, highlighted the importance of ORLYNVAH's approval, especially in the context of the uncomplicated urinary tract infection (uUTI) market in the U.S. With a staggering 60% of adult women experiencing a UTI in their lifetime, and 40% of those women having recurrences, the market size is vast, representing an estimated 40 million prescriptions annually. This approval could not have come at a better time, as the current leading product, Nitrofurantoin, was approved in 1953, and most oral products have substantial resistance rates approaching 20%. Moreover, the safety concerns associated with these products create challenges for treating physicians, forcing them to rely on potentially less effective options.

Combating Antibiotic Resistance with ORLYNVAH

The approval of ORLYNVAH brings hope to patients with limited or no alternative oral treatment options, particularly elevated risk patients, such as the elderly, those with diabetes, or those with co-morbidities that negatively impact their immune systems. These patients are most at risk and pose a significant need for new, efficacious, and safe oral treatment alternatives. Additionally, approximately 1% of patients in the REASSURE uncomplicated urinary tract infection clinical trial had isolates resistant to all available oral antibiotics. ORLYNVAH could potentially play a crucial role in addressing this pressing issue, as it is approved for treating E. coli, Klebsiella pneumoniae, and Proteus mirabilis, which account for over 95% of all uncomplicated UTIs.

A Comprehensive Label and Commercial Elements

The label for ORLYNVAH, as discussed by Dr. Steven Aronin, is competitive with other oral antibiotic labels, emphasizing the importance of using it appropriately. Given that ORLYNVAH is the first oral penem antibiotic, it includes language reminding prescribers to use it wisely and only for patients with uncomplicated UTIs caused by susceptible bacteria. The label also highlights the importance of antibiotic stewardship to maintain the effectiveness of the antibiotic. The post-marketing requirements include studies on pediatric populations and surveillance studies to monitor resistance development.

The commercial elements discussed by Corey Fishman suggest that ORLYNVAH's success in the market could be driven by its unique value proposition. By educating physicians about antibiotic resistance and resistance rates in their practice areas, Iterum Therapeutics aims to help doctors make informed decisions about antibiotic selection. Additionally, a favorable branded price point could further enhance the commercial opportunity. A targeted launch strategy, focusing on high writer segments, and comprehensive patient services could optimize patient outcomes and promote physician adoption.

Looking Forward: Maximizing Value for Stakeholders

With the approval of ORLYNVAH, Iterum Therapeutics is set to renew its efforts to achieve a strategic transaction involving ORLYNVAH, with the goal of maximizing value for stakeholders. This could include licensing, selling, or other disposal of rights to ORLYNVAH. The future looks promising for Iterum Therapeutics, as ORLYNVAH holds significant potential to address the unmet needs in the uUTI market and combat the growing health crisis of antibiotic resistance.

In conclusion, the approval of ORLYNVAH by the FDA marks a significant milestone for Iterum Therapeutics, opening up a new era in the treatment of uncomplicated urinary tract infections. With its unique value proposition, ORLYNVAH could potentially address the challenges faced by physicians in treating patients with limited or no alternative oral treatment options and help combat the growing health crisis of antibiotic resistance. As Iterum Therapeutics continues to navigate the strategic transaction process, stakeholders can look forward to a bright future with ORLYNVAH leading the charge.