Iterum Therapeutics plc

Good morning. Thank you for attending today's interim Therapeutics Second Quarter 2025 Financial Results in Business Update call. My name is Mechon and I'll be your moderator for today. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. I would now like to pass the conference over to Kevin Dalton, Senior Director Legal Affairs. Thank you, you may proceed.

Thank you, speaker. Good morning and welcome again to Iterum Therapeutics' Second Quarter 2025 Financial Results in Business Update Conference call. A press release with our Second 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, and Judy will provide detail on our financial results and an update on the finance-related proposal at our upcoming 2025 Annual General Meeting of shareholders. And then we will open the lines for Q&A. Before we begin, I would 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. These include the development, therapeutic, and market potential of Orlinva, including the estimated annual prescriptions from targeted positions, the sufficiency of our cash resources to fund our operating expenses into 2026, our ability to complete the commercial launch of Orlinva in the U.S. on our round August 20, 2025, our ability to expand into new territories and put additional resources in high prescribing geographies and to expand the payer coverage of Orlinva in the U.S., the sufficiency of our current stock of product in the U.S. to satisfy our commercial requirements into the timelines expected, our ability to raise funds either through a capital raise and or revenue generated from sales of Orlinva, the opportunity to engage in a business development or transaction to sell, license, or otherwise dispose of our rights to Fulopenem, and the protection provided by our payments. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including our ability to successfully prepare and implement commercialization plans for Orlinva with Eversana, our ability to build and maintain a sales force and complete the commercial launch of Orlinva on the timeline expected, the market opportunity for and the potential market acceptance of Orlinva, the actions of third-party suppliers, manufacturers, and clinical research organizations, our ability to continue as a going concern, the accuracy of our expectations regarding how far into the future our cash on hand will fund our ongoing operations, and finally, all other factors discussed under the caption, risk factors in our annual report on Form 10Q as filed at the SEC this morning. In addition, any forward-looking statements represent our views only 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 the statement. We will also be referencing non-GAAP financial measures during the call. We have provided reconciliation of GAAP reports to non-GAAP adjusted information in the press release issued this morning. With that all said, I'll turn it over to you, Corey, for your opening remarks.

Thanks, Kevin. Welcome and thanks for joining us today. We have several exciting updates on our progress toward commercialization to discuss, and I'll do that in just a minute. First, I want to address a couple of items that continue to be raised by our investors so that the company's position is very clear. As it relates to the company strategy, Iterum will be launching and commercializing Orlinva in the US. While a business development transaction remains a potential opportunity for Iterum at any point, including during the commercialization phase for Orlinva, we believe that successfully launching Orlinva into the uncomplicated urinary tract infection market in the US to help address the significant unmet need that exists for patients is critical and could also potentially build tremendous value in Iterum. Additionally, we have hired an outstanding chief commercial officer, Christine Coyne, who has been and will continue to lead our launch and commercialization activities. Over her 30-year career in pharmaceuticals and biotech, Christine has worked across sales, marketing, market access and operations, and had P&L responsibility for numerous significant brands and launches spanning hospital and retail settings. Additionally, she has built comprehensive commercial plans and successfully launched antibiotics and antifungals into the market. She has been working seamlessly with our Eversana commercial team and has already proven to be a tremendous addition to the Iterum team. Now I'd like to provide our investors with some very exciting updates regarding the commercialization of Orlinva. We are very pleased to share with you that we expect to launch Orlinva around August 20th, a bit ahead of our previously announced timeline. Along with our commercialization partner, Eversana, we have been focused on launching as soon as possible in order to get this important product into the hands of physicians and their patients. We believe we will be the first new branded product launched in the uncomplicated urinary tract infection space in over 25 years. The uncomplicated urinary tract infection market in the US has a number of favorable factors that make it quite attractive commercially. The market itself is relatively large and based on our research generates approximately 40 million prescriptions annually in the US. Of those prescriptions, approximately two thirds or about 26 million prescriptions are written for at-risk patients. At-risk patients are defined as women who are elderly, women with comorbidities like diabetes, heart failure, kidney failure, or cancer, or women with a history of recurrent infections. We believe these at-risk patients are Orlinva's addressable market as they are likely the patients with limited or no other oral treatment options available and are the patients most in need of new therapies. There have been no new branded oral treatments launched in the uncomplicated urinary tract infection market in the US in over 25 years. Additionally, it would appear from our antimicrobial resistance research that rising rates of resistance is eroding the efficacy of the existing older oral treatments. Lastly, almost all of the existing oral products have safety challenges that physicians need to consider when choosing which product to prescribe. These challenges range from existing products not being recommended for use in uncomplicated infections to products being contraindicated in patients with low creatinine clearance. With these current market dynamics as a backdrop, we believe it's easy to understand the significant need for new, efficacious, and safe treatment alternatives to effectively treat all patients and particularly those at-risk patients that we just described. In the first phase of our launch, we plan to have sales resources in 20 targeted geographic territories. These territories were selected based on the estimated number of prescriptions written by high-value physicians, the rate of antibiotic resistance in that territory, and expected market access in that territory. These territories are generally clustered around major metropolitan areas and are located in seven states, New York, New Jersey, Connecticut, Pennsylvania, Georgia, Florida, and Texas. Our sales team, as provided by Eversana, will cover around 2,300 physician targets who are all high-value prescribers. Of these physician targets, the majority are primary care physicians, followed by OBGYNs and urologists. In total, these target physicians are currently estimated to rate between 1 and 2 million prescriptions annually for uncomplicated urinary tract infection products. Our market access and clinical teams have been out in the market working with payers and managed care organizations, helping them understand the clinical and economic value of ORLNVA. While still early, these payer discussions have resulted in interest in ORLNVA. We aim to continue these discussions by providing additional detailed information on the overall value ORLNVA can provide to the payers. Our ultimate goal is for patients to have access to ORLNVA in a majority of key plans. We have set our wholesaler acquisition costs, which represents our gross price before discounts, within the range established by other oral antibiotic launches for products that are used in other infection types. The range of this pricing is between $1,400 and $4,700 per course of treatment. And importantly, at these gross prices, these products enjoy very good market access. Very importantly, along working on payer coverage of ORLNVA and access to the product for patients, Iterum plans to help defray -of-pocket expenses where possible for appropriate patients. As we progress through the first phase of our launch over the coming months, we will continue to refine and optimize our physician targeting and resourcing in our key geographies. If this initial launch is successful, we will aim to expand our commercial resources in the field in order to increase revenue generation. This expansion could include adding additional high-value geographies, as well as potentially adding more high-value physician targets to our call plans in existing territories. As we think about acute therapies like ORLNVA in the treatment of uncomplicated urinary tract infections, speed to therapy, which is the time it takes for a patient to receive ORLNVA once a physician has written a prescription, is very important. These women are, in many cases, seeing their physician because they are dealing with the discomfort stemming from the symptoms of an uncomplicated urinary tract infection. Our goal is to get ORLNVA to the patient as soon as possible. We have selected a specialty pharmacy that should help us optimize speed to therapy by leveraging both their technology that assists in clearing any potential requirements for managed care companies, such as prior authorizations, as well as the specialty pharmacy's delivery capabilities, which include pickup at a local pharmacy, courier services, and overnight shipments. Now I'd like to spend a moment and speak about manufacturing and supply of ORLNVA. As you may have seen yesterday, we have executed a commercial supply agreement with our finished product supplier, ACS-Dobfarr, located in Italy. This agreement also covers supply of sulopenamethadroxyl bulk drug substance. ACS-Dobfarr is a leading manufacturer of IV penam products globally, and a number of years ago, we commissioned the construction of a separate tabletting suite at one of their facilities to provide ORLNVA. We have had a long and extremely productive partnership with ACS-Dobfarr over the last decade, and look forward to continuing that relationship well into the future. The execution of this supply agreement is an essential element of our commercialization strategy, as we now have a world-class FDA approved manufacturer contracted to make our active pharmaceutical ingredient and our commercial product on an ongoing basis subject to the terms of the agreement. As a reminder, we have excellent expiration dating of ORLNVA with a shelf life of six years from the date of manufacture. This provides an advantage with distributors in the market, as many other competitors and any new potential market entrance will likely have a shorter expiration timeframe. We have successfully shipped our finished product to the US, it has cleared inspection and customs, and is ready to ship to our specialty pharmacy. We expect that the quantity of product we already have available in the US will satisfy our commercial requirements into mid to late 2026. Another important item that we have previously disclosed was the extension of our $20 million regulatory payment owed to Pfizer. The due date of this payment was initially October of 2026 after interim exercised its deferral option, and this payment is now due in October of 2029. This has removed a near term financial obligation from next year and allows a greater portion of any revenue generated by ORLNVA or any additional capital raised to be used to continue to fund the commercialization of ORLNVA. On the intellectual property front, we have two types of protection for ORLNVA, market exclusivity and patents. On the market exclusivity front, the FDA has designated ORLNVA as a qualified infectious disease product for uncomplicated urinary tract infections and a number of other indications. In October 2024, upon approval of ORLNVA, the FDA confirmed an additional five years of market exclusivity under the GAIN Act, resulting in a total of 10 years of market exclusivity in the US from the date of approval. Therefore, the market exclusivity that FDA has granted ORLNVA will expire in October of 2034. On the patent front for ORLNVA, we exclusively licensed from Pfizer one US patent and three foreign patents. Additionally, we own four US patents, one Japanese patent, one Korean patent, two Australian patents and now one Canadian patent, which we were pleased to have been granted by the Canadian Patent Office in July. The patents owned by us are scheduled to expire between 2039 and 2041, excluding any additional term for patent adjustments or patent term extensions. We also own three pending US patent applications and 25 pending foreign patent applications, which collectively cover uses of sulopenum and probenicid and bilayer tablets of sulopenum, ethydroxal and probenicid. With the combination of marketing exclusivity and patent protection, we believe ORLNVA will have a very long runway to create value. In summary, we are extremely excited to be launching ORLNVA in the next few weeks and are looking forward to bringing this important treatment option to physicians and their patients. Now I'll turn the call over to Judy Matthews for a financial update.

Thanks, Corey. Total operating expenses were $5.5 million in the second quarter of 2025, compared to $4 million in the second 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 $1 million for the second quarter compared to $2.1 million for the same period in 2024. The primary driver of the decrease in R&D expense for the second quarter was the decrease in costs associated with the REASSURE trial. G&A costs were $4.2 million for the second quarter, compared to G&A costs of $1.9 million for the same period in 2024. The primary driver of the increase in G&A expense for the second quarter was pre-commercialization activities. Our net loss on a US GAAP basis was $6.5 million for the second quarter of 2025, compared to a net loss of $5 million for the second quarter of 2024. On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $5.1 million in the second quarter of 2025, compared to our non-GAAP net loss of $3.8 million in the second quarter of 2024. The $1.3 million increase in our non-GAAP net loss for the second quarter was primarily a result of higher G&A due to spending on pre-commercialization activities. At the end of June, we had cash and cash equivalents of $13 million. Based on our current operating plan, which includes our expected launch, commercial launch later this month, we expect that our cash and cash equivalents, together with $2.2 million of net proceeds raised under our -the-market offering program from July 1st through August 1st, 2025, will be sufficient to fund our operations into 2026. As of August 4th, 2025, we had approximately 44.7 million ordinary shares outstanding. On September 10th, we are holding our annual general meeting of shareholders. And many of you will have noted from our proxy statement in the voting ballots that have gone out, that we have requested authorization of an additional 80 million shares, which is a 100% increase to the existing authorized share capital of the company. Based on proxy proposals to increase the authorized share capital of 41 peer companies during 2024 and 2025, an addition of this size is in line with our peers. The purpose of this proposal is a matter of good housekeeping to ensure we have the financial flexibility to fund the strategic objectives of the business, including the upcoming commercial launch, until such time as we might reach cash flow breakeven. As always, we will exercise care when issuing shares. Additionally, as an Irish company, we are seeking a waiver of preemption rights on those potentially newly authorized shares. Without this waiver, we are limited in the types of financing we can execute. The financings available to us without having a waiver of preemption rights in place are more costly and more dilutive to you, our shareholders. So we ask that you please vote in favor of these proposals at the upcoming annual general meeting. Now I will turn it over for questions.

Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by two. Again, to ask a question, please press star one. As a reminder, if you're using a speakerphone, please remember to pick up your handsets before asking your question. We will pause here briefly to allow questions to register. There are no questions registered at this moment. So as a reminder, it is star one. There are no questions registered at this moment. So I would like to turn the call back over to Mr. Fishman for closing remarks.

Thank you, Megan. In closing, we have made tremendous progress and are very excited for our upcoming launch. Over the last few months, as our plan to launch has been communicated, we have received numerous inquiries about our LNVA and the timing of its availability. Along with our commercialization partner of Orsana, we believe there's a significant need for LNVA in the US uncomplicated urinary tract infection market and are looking forward to providing the first and only approved oral penum in the US to physicians and their patients. We appreciate our investors' continued support as Iterum enters this new phase in its evolution into a commercial entity. Thanks for joining us today and have a great day.

This concludes today's conference call. Thank you for your participation and enjoy the rest of your day.