Iterum Therapeutics plc

Hello everyone and thank you for joining the interim therapeutics plc first quarter 2025 earnings and business update call my name is lucy and i'll be coordinating your call today during the presentation you can register a question by pressing star followed by one on your telephone keypad if you change your mind please press star followed by two on your telephone keypad i will now hand over to your host louise barrett svp of legal affairs to begin please go ahead thank you lucy

Good morning and welcome to Interim Therapeutics PLC first quarter 2025 earnings and business update calls. A press release of the first quarter results was issued earlier this morning and can be found on our website. We are joined this morning by our Chief Executive Officer, Corey Fishman, and our Chief Financial Officer, Judy Matthews. Corey will provide some opening remarks, Judy will provide details on our financial results, and then we'll open the lines for Q&A. Before we begin, I'd like to remind you that some of the information presented on this conference call will contain forward-looking statements concerning our plans, strategies and prospects for our business, including the development, therapeutic and market potential of our LINDA, the sufficiency of our cash resources to fund our operating expenses into 2026, our strategic process to sell, license or otherwise dispose of our rights to Sula Penham, Our ability to complete pre-commercialization activities for our LINVA and prepare for a potential launch of our LINVA by the fourth quarter of 2025 and the protection provided by our patents. Actual results may differ material from those indicated by these four looking statements as a result of various factors outside our control. Including risks and uncertainties concerning the outcome, impact, effects and results of our evaluation of strategic alternatives. including the terms, timing, structure, value, benefits, and cost of any strategic alternative, our ability to complete a strategic alternative transaction, our ability to successfully prepare and implement commercialization plans for our LINBA with a commercial partner or directly, the design and timing of potential launch plans, the market opportunity for and potential market acceptance of our LINBA, our ability to continue the going concern, the accuracy of our expectations regarding how far into the future our cash in hand will fund our ongoing operations, and other factors discussed under the caption risk factors in our quarterly report on Form 10Q filed with the SEC this morning. In addition, any forward-looking statements represent only our views as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We've provided reconciliations of GAAP reporters to non-GAAP adjusted information in their press release issues this morning. With that all said, now I'll turn it over to you, Corey, for your opening remarks.

Thanks, Louise. Welcome, and thanks for joining us today. I'd like to begin by providing some comments on our company priorities and associated activities. Our outreach to potential business development partners has yet to result in a transaction that the Board views as acceptable, being in the best interests of our stakeholders. Business development remains a potential opportunity for us at any point, and while we continue to pursue a strategic transaction, we remain open and excited to engage in discussions as they arise. Having said that, we believe there is urgency to bring Oralindra to the U.S. market to serve patients suffering with uncomplicated urinary tract infections who have limited or no other oral alternative treatment options. And as such, we have been preparing for the potential commercialization of Oralindra over the last several months. As we have noted before, the U.S. market has been plagued by a lack of innovation in this therapy area over the last 25 years and antibiotic resistance to existing generic oral treatment options is eroding the efficacy of current therapies. Additionally, almost all of the existing oral treatments have some safety challenges that again leaves physicians looking for efficacious and safe alternative treatments. Given this background, And with the safety and efficacy of Orlinva for the treatment of uncomplicated urinary tract infections in adult women with designated microorganisms, we believe there's an excellent opportunity in this expensive market, which has been hugely neglected for nearly three decades. Let's take a moment now and talk about the uncomplicated urinary tract infection market in the U.S. It is quite large, and based on our research, generates approximately 40 million prescriptions annually in the U.S., and of those, approximately two-thirds, or about 26 million prescriptions, are written for at-risk patients. At-risk patients are defined as women who are elderly, have comorbidities like diabetes, heart failure, kidney failure, or cancer, or women with a history of recurrent infections. We believe these at-risk patients represent or limit addressable market as they likely are the patients with limited or no other oral treatment options available and are the patients most in need of new therapies. To put this addressable market size in a practical perspective, If a company were to capture a 1% share of the addressable market at peak, say the fifth or sixth year after launch, and using current branded oral antibiotic pricing, resulting net sales would be over $250 million in that year. With regard to new competition in the marketplace, There was a product approved in April of 2024 that has yet to launch. Additionally, in the first quarter of this year, GlaxoSmithKline received approval for a product in the uncomplicated urinary tract infection space, and their current guidance is that they will launch in the second half of this year. Clearly, this increases the urgency for us to get Orlimba to market as quickly and efficiently as possible. I want to spend a minute and talk about the potential commercialization of Orlymba. We have been working with Eversana, an end-to-end commercialization firm, to prepare for a potential launch. As we build out our commercial launch plan, we have invested in pre-commercialization activities, including market research with physicians and payers, building the key promotional messaging for Orlymba, determining the optimal trade distribution, and patient services strategies, developing discussion materials for payers, beginning to compile a medical information database, and determining potential territory alignment for sales resources. We believe that all the work done so far indicates Oralinva as an important alternative for patients with limited or no other oral treatment options. In a commercialization scenario, we would expect to execute our launch in phases. Our first phase would be to put commercial resources in a limited number of territories based on three key criteria. Number one, the rate of antibiotic resistance in that territory. Number two, the number of physicians in a territory who read a large amount of prescriptions in the uncomplicated urinary tract infection field. And number three, manage care access in a designated territory. Post-launch, assuming we see solid results in these initial territories, we expect the next phase of the plan would be to either expand the number of territories we are promoting in, still using the same three criteria to determine optimal geographies, or to remain in the existing territories or cover more physicians in those territories with additional resources. Of course, any near-term expansion would be subject to successfully raising additional capital. We expect that in a commercialization scenario, we will be able to launch Orlimba in the U.S. market by the fourth quarter. There are a couple other topics I'd like to cover today as well. As some of you may know, In January of this year, we repaid the outstanding principal and interest due under our exchangeable notes. This repayment eliminated a large amount of debt that has been on the company's books for a number of years. Lastly, we have extended our cash runway into 2026, which includes the potential launch of Olinva by the fourth quarter. In summary, as we look forward, we are very excited about the potential commercialization of Orlunda in the U.S. The market dynamics remain favorable, our planning work is going very well, no new products have launched in the space to date, and we have a very long runway to capture value with our patent protection going into 2039. I'll now turn the call over to Judy Matthews, our Chief Financial Officer, for a financial update.