Iterum Therapeutics plc Price & Performance (ITRM)

Hello, everyone, and welcome to the Therapeutics PLC Fourth Quarter and Full Year twenty twenty four Financial Results. My name is Ezra, and I will be your coordinator today. I will now hand you over to Louise Barrett, Senior Vice President, Legal Affairs to begin. Louise, please go ahead. Thank you, Idra. Good morning and welcome to Idra Therapeutics fourth quarter and full year twenty twenty four financial results and business update conference call. A press release with our fourth quarter and full year results 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 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 Q and 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 LINVAT, the sufficiency of our cash resources to fund the operating expenses into the second half 2025, or strategic process to sell, license or otherwise to dispose our rights to Arlenbach Our ability to complete pre commercialization activities for Arlinba or ability to develop a commercial launch plan either directly or with a commercial partner if we are on [indiscernible] and the expected issuance of patents and the term and coverage provided by such patents on issue. Actual results may differ materially from those indicated by these forward looking statements, as a result of various factors outside of our control. Including, but not limited to, risks and uncertainties concerning the outcome, impact of effects and results of our evaluation of strategic alternatives, including the terms, timing, structure, values benefits and costs of any strategic alternatives our ability to complete a strategic alternative transaction our ability to raise sufficient capital and successfully prepare and implement commercialization plans for Aninda with a commercial partner or directly if we were a success in entering into or completing a strategic transaction.

The market opportunity for and the potential market acceptance of Arlinva, our ability to continue as a growing concern, the accuracy of our expectations regarding how firearms the future are cash in hand with Thunder ongoing operations and other factors discussed under the Captain caption Risk Factors in the annual report filed with the SEC this morning and other documents filed with the SEC from time to time. 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 reported to non GAAP adjusted information in the press release issued this morning. Now with that all said, 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 provide a brief recap of 2024 and talk a bit about key activities and milestones in 2025.

Overall, 2024 was a very good year for Interim. In January, we generated positive results in our pivotal Phase three ReAssure clinical trial comparing oral sulopetim to Augmentin, in adult women with uncomplicated urinary tract infections, very efficiently pulled together our NDA resubmission which was submitted in In September, we had a successful advisory committee meeting and in October of twenty twenty four, received FDA approval for Orlynda, the brand name for our oral sulupenim bilayer product Orlynda is indicated for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms E. Coli Klebsiella and Ammonia, or Pertius Marebilis in adult women who have limited or no alternative oral antibacterial treatment options.

Orlinza is the first and only approved oral penum in The United States. Now, I'll share a few comments with you as to why we are so excited about the potential for Olinda in the market. The uncomplicated urinary tract infection market The U. S. Is quite large. And generates an estimated 40,000,000 prescriptions annually.

Orlynda is the first and only oral penum approved in The United States and the second FDA approved treatment for Orlynda will potentially be the first branded product to enter the uncomplicated urinary tract infection market in over twenty five years. The leading product in the uncomplicated urinary tract infection market nitrofurantoin, was approved in 1953.

And the majority of the other oral products in the market were approved in the 1970s and 1980s. The extensive use of these products over time has led to rising resistance rates, resulting in the most widely used products having resistance rates approaching twenty percent and those rates can run as high as thirty percent. As most prescribing for uncomplicated urinary tract infections occurs empirically, increasing resistance rates creates a challenge for practicing physicians since the efficacy of these products are continuing to be eroded over time. Additionally, almost all of the widely used oral products in this therapy area have some safety concerns that again create challenges for treating physicians as to their choice of agent to use. Unfortunately, with almost no innovation in decades, physicians have been forced to use agents that may not work as well as they would like for their patients.

With the Orlynda approval, there now could be an alternative treatment option for those patients who have limited or no other oral treatment options available. We believe that there are many patients that fall into this category specifically elevated risk patients.

We define elevated risk patients as women that fall into any of the following categories: women who are 65 years or older, women who have diabetes, women with a history of recurrent or drug resistant infections, or women that have other comorbidities that negatively impact their immune systems. This group of patients are most at risk given their profiles, and many physicians are challenged to treat these patients with existing oral that have substantial resistance as well as safety hurdles. Another key group of patients in this therapy area that are in significant need of a new efficacious and safe oral treatment alternative are the patients that have pathogens resistant to all commonly used oral antibiotics? In our ReAssure uncomplicated Urinary Tract Infection pleaded last year and conducted exclusively in The U. S. Across almost one thousand patients we found that approximately one percent of these patients had an isolate that was resistant to all available oral antibiotics. Orlynda could play an important role in treating these patients as well. As we look at protection for Orlinva, with the formal confirmation from the FDA, of five additional years of marketing exclusivity under the GAIN Act, or Lindba has market exclusivity for a total of ten years from the date of approval or until October 25, 02/1934.

Additionally, our U. S. Patent portfolio provides protection for Olinda into 02/1939. With issued U. S. Patents covering both method of use and composition of matter. If submitted patent information for four U. S. Patents for Olynba that are listed in FDA's Orange Book approved drug products with therapeutic equivalent evaluations. Generic product. In addition to the in license and issued patents we have, there are a number of pending patent applications in The U. S. And other jurisdictions including Europe and China. As we enter 2025, there are a few items to note. Our key priority remains the previously announced strategic process to sell license or otherwise dispose of our rights to Orlimba with the goal of maximizing value for our stakeholders. Along with our financial we have conducted outreach to dozens of companies since our approval and have and will continue to engage with those that are potentially interested in a strategic transaction. As neither Iterum nor our financial advisor appointed to assist the Board in evaluating various strategic alternatives is in control of whether our efforts on the strategic front will result in any definitive offer to consummate such a transaction or if we do receive a definitive offer, whether the terms are as favorable as anticipated or acceptable to the Board, in parallel to the strategic process we have begun to evaluate other options for maximizing the value of Orlinba which may include seeking to raise capital to support the commercialization of OrlinBA.

We plan to engage in pre commercial the foundation for a highly targeted launch of Orlynda with a commercial partner or directly, subject to raising sufficient capital, to ensure that the product is made available to patients and physicians as soon as possible. On the financial side, we have repaid the principal and interest due under our exchangeable notes at the January in accordance with their terms. Additionally, based on our current operating plan, including currently planned pre commercialization activities, we expect our cash will be sufficient to fund operations into the second half of twenty twenty five. Now, I'll turn the call over to Judy Matthews, our CFO financial update. Thanks, Corey.

Total operating expenses were $3,700,000 in the fourth quarter and $18,700,000 for the full year 2024 compared to $11,400,000 and 47,500,000.0 in the fourth quarter and full year 2023. Our 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 and D costs were $1,300,000 for the fourth quarter and $10,500,000 for the full year 2024, compared to $9,700,000 and 40,000,000 for the same periods in 2023. The primary driver of the decrease in R and D expense for the fourth quarter and full year was the completion of the ReAssure trial. G and A costs were $2,100,000 for the fourth quarter and $8,000,000 for the full year 2024. Compared to G and A costs of $1,700,000 dollars and $7,500,000 for the same period in 2023. The primary driver of the increase in G and A expense for the fourth quarter and full year was higher legal fees. Our net loss on a U. S. GAAP basis was $6,600,000 for the fourth quarter of twenty twenty four and four point eight twenty four point eight million dollars for the full year. On a non GAAP basis, which excludes certain non cash our net loss of $3,100,000 and $17,600,000 for the fourth quarter and full year 2024. Compared to our non GAAP net loss of $10,700,000 and $43,800,000 for the fourth quarter and full year 2023. The $7,600,000 and $26,200,000 decrease and our non GAAP net loss for the fourth quarter and full year was primarily a result of lower R and D [indiscernible] At the December, we had cash and cash equivalents of $24,100,000 Based on our current operating plan, which includes our currently planned pre commercialization spend, we expect that our cash and cash equivalents including $4,800,000 of net proceeds raised under our ATM from January 1, through 02/06/2025, will be sufficient to fund our operations into the second half of twenty twenty five.

Pursuant to our exclusive license with fiber for Silopan $20,000,000 to Pfizer upon approval of oral thulopenem. In accordance with the license, we elected to defer payment for two years and delivered a promissory note to Pfizer in the amount of $20,000,000 in October 2024. This note accrues interest at an annual rate 8% on a daily compounded basis until paid in full. On 01/31/2025, we repaid the outstanding principal and interest due under the exchangeable notes in accordance with their terms. As of February 6, 2025, we had approximately 34,600,000.0 ordinary shares outstanding. We will now open it up for questions. Our first question comes from Ed Arca with H. C. Brinratz. Ed, your line is now open. Please go ahead.

Hello. Good morning, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you much for taking our questions. Perhaps first question, wonder if you can discuss any feedback or details on your ongoing discussions with potential partners and also if you can discuss what type of entities you're having discussions with such as pharma companies or financial organizations what type of partners are you seeking out currently? As you'd imagine, we really can't talk in detail about any any ongoing conversations. What I will say is I mentioned, is we have had outreach to dozens of companies, which include both pharma companies as well as financial investors, and that process is ongoing. Understood. And then on the other side, you mentioned that there commercial preparations ongoing I wonder if you can highlight some activities on that front? [indiscernible] So we are currently engaging in some research with payers, with physicians, we're also doing some analytics around targeting, around geographies, all in the Instead of putting the foundation in place should we end up in a place where the strategic transaction does not occur, or the strategic transaction doesn't generate something that is sufficient in the Board's eyes for a commercial launch either by us or with a commercial partner here at Iterim.

Understood. That's all the questions we have for now. Thank you so much for taking the questions and look looking forward to progress in ongoing discussions. Thanks, Thomas.

Thank you very much.

Just as a reminder, if you would like to ask a question, We currently have no more questions. I will hand back over to Corrie Fishman for any closing remarks.

Thank you. We appreciate you joining us today Believe the uncomplicated urinary tract infection market is underserved and that there is a substantial unmet need for effective treatment options. We look forward to Orlynda entering The U. S. Market and ensuring Orlynda is made available to patients and physicians in order to provide this important treatment option to treat uncomplicated urinary tract infections. Thanks again and have a good day. Thank you very much, Corey, and thank you our speakers on today's call This concludes today's conference call. You may now disconnect your lines.