Iterum Therapeutics plc

Hello everyone and thank you for joining the Iterum 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 Iterum Therapeutics PLC First Quarter 2025 Earnings and Business Update Call. A press release of the first quarter results is issued earlier this morning and can be found on our website. We are joined this morning by our Chief Executive Officer Corey Bichman 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 developments, therapeutic and market potential of Arlinda, the sufficient over cash resources to fund our operating expenses into 2026, our strategic process to sell, license or otherwise dispose of our rights to Sula Penum, our ability to complete pre-commercialization activities for Arlinda and prepare for a potential launch of Arlinda by the fourth quarter of 2025 and the protection provided by our patents. Actual results from these different materials from those indicated by these forward-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 Arlinda with a commercial partner or director, the design and timing of potential launch plans, the market opportunity for and potential market acceptance of Arlinda, 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 files of 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 the 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 Orlynda 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 Orlynda over the last several months. As we have noted before, the U.S. market has been plagued by a lack of innovation in the 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 Orlynda 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 Orlynda's 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 the company were to capture a one percent 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 dollars 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 Orlynda to market as quickly and efficiently as possible. I want to spend a minute and talk about the potential commercialization of Orlynda. We have been working with Eversana, an -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 Orlynda, 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 of the work done so far indicates Orlynda 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, the managed 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 but 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 Orlynda 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 Orlynda by the fourth quarter. In summary, as we look forward, we are very excited about the potential commercialization of Orlynda 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.

Thanks, Corey. Total operating expenses were $3.7 million in the first quarter of 2025 compared to the $6.2 million in the first quarter of 2024. Operating expenses include cost of sales, which is primarily the amortization of an intangible asset, research and development expenses, and general and administrative expenses. R&D costs were approximately $600,000 in the first quarter compared to $4 million for the same period in 2024. The primary driver of the decrease in R&D expense for the first quarter was the decrease in costs associated with the reassure trial. G&A costs were $2.8 million for the first quarter compared to G&A costs of $2.2 million for the same period in 2024. The primary driver of the increase in G&A expense for the first quarter was pre-commercialization activities. Our net loss on a U.S. GAAP basis was $4.9 million for the first quarter of 2025 compared to a net loss of $7.1 million for the first quarter of 2024. On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss was $3.3 million in the first quarter of 2025 compared to our non-GAAP net loss of $5.8 million in the first quarter of 2024. The $2.5 million decrease in our non-GAAP net loss for the first quarter was primarily a result of lower R&D expenses related to our reassure trial. At the end of March, we had cash and cash equivalents of $12.7 million. Based on our current operating plan, which includes our currently planned pre-commercialization spend and potential commercial launch of Orlinda by the fourth quarter of 2025, we expect that our cash and cash equivalents, together with $1 million of net proceeds raised under our -the-market offering program from April 1st through April 22nd, 2025, and that proceeds of $4.2 million from the registered direct offering that closed April 30th, 2025, will be sufficient to fund our operations into 2026. On January 31st, 2025, we repay the outstanding principal and interest due under the exchangeable notes in accordance with their terms. As of May 12th, 2025, we had approximately $40 million ordinary shares outstanding. Now we will open the line for questions.

Thank you. To ask a question, please press star followed by 1 on your telephone keypad now. If you change your mind, please press star followed by 2. When preparing to ask your question, please ensure your device is unmuted locally. We have a question from Matthew Keller of HC Wainwright. Matthew, your line is now open. Please go ahead.

Yeah, thank you. Good morning, everyone, and thanks for taking our questions. Just two quick ones from us. The first, I was wondering if you could possibly speak a little bit more to the maturity of these conversations you're having with our potential commercial partners. And then secondly, do you foresee any, if any, really outstanding rate-limiting steps ahead of launch later this year?

Matt, this is Corey. Thanks for the questions. Can you just repeat the second one? I'm sorry.

Oh, yeah, no problem. Just if you foresee, you know, you mentioned the pre-commercialization activities. If there's any other outstanding rate-limiting steps that you might foresee ahead of or Linda's launch later this year.

Gotcha. Okay, thanks. So let's tackle them and know where you asked them. You know, there's really not a lot of color we can add on any commercial partner discussions. I'm assuming that meant sort of the BB side of it. You know, we do view Eversana as our commercial partner, but I'm assuming that's not really what you were asking. I think we've had a number of big discussions. I think there's a host of of rationale in people's minds as to why right now may not be the right time from their perspective to do any kind of partnership with us. But it's important to note, as I said, you know, that business development is a constant in the biotech world and certainly for us as well. There's there's never a, you know, a long time for that conversation. So we absolutely remain open to it. We, you know, we'd be happy to have those conversations with the specific parties if and when they arise. And we will certainly do that. Having said that, you know, we really do feel there's an urgency here. We've been approved for six months. The market continues to be attractive and, you know, we really think that that or Linda can play a very important role in treating these adverse patients. And so we really want to get this product into the hands of patients and physicians. And that's really our goal. And that leads into your second second question, which are there are there any rate limiting steps kind of remaining in order to be launching the drug by the fourth quarter? And I'm happy to tell you that I don't see any big hurdles. There's a ton of work to do. But with regard to real impediment, there there are no, you know, no hurdles out there that would stop us from staying on that timeline. The good news is we've commercial sorry, not commercial. We've made product and we have product available. So it's not like we have manufacturing, you know, timelines to deal with right now. And so I think we're in pretty good shape to actually hit that timeline of getting commercial by the fourth quarter.

Yep, no, totally makes sense. Thanks for taking my questions. And again, congrats on the quarter. Thanks again.

We have no further questions, so I will hand back to Corey Fishman, CEO for closing remarks.

Thanks, Lucy. We appreciate you joining us today. We're very excited about the potential launch of or Linda by the fourth quarter of this year. We believe there really is a significant need for Linda in the uncomplicated urinary tract infection market for those at risk patients. And we are looking forward to making this first and only approved oral product available to patients and physicians as efficiently and quickly as we can. So thanks again and have a great day, everyone.

This concludes today's call. Thank you for joining. You may now disconnect your lines.