Iterum Therapeutics - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 was pivotal: FDA approved ORLYNVAH (oral sulopenem), extending exclusivity to October 2034 and bolstering IP protection into 2039, while management initiated outreach to strategic partners and began targeted pre-commercialization work.
• Losses narrowed year over year: GAAP net loss of $6.6M vs. $12.4M in Q4 2023; non-GAAP net loss of $3.4M vs. $10.7M (drivers: sharp R&D decline post-REASSURE trial).
• Liquidity strengthened: Cash/equivalents of $24.1M at year-end plus $4.8M raised via ATM through 2/6/2025 support runway into H2 2025; exchangeable notes repaid in January 2025; Pfizer $20M milestone deferred (8% accrued interest).
• Stock catalysts: Strategic transaction potential; targeted launch readiness; ORLYNVAH’s first-in-class oral penem positioning in a large uUTI market facing rising resistance (estimated ~40M U.S. prescriptions annually).

What Went Well and What Went Wrong

What Went Well

• FDA approval of ORLYNVAH for adult women with uUTIs who have limited or no alternative oral options; “first and only oral penem approved in the U.S.”.
• Exclusivity and IP: 10 years of marketing exclusivity under GAIN Act (to Oct 2034) and U.S. patents that provide protection into 2039; Orange Book listings submitted.
• Cost discipline: R&D fell to $1.3M in Q4 (vs. $9.7M prior year) after completing REASSURE, materially improving non-GAAP results; management: “lower R&D expenses related to our REASSURE trial” drove improvement.
• Quote: “ORLYNVAH will potentially be the first branded uUTI product to enter the U.S. market in over 25 years” – CEO Corey Fishman.

What Went Wrong

• No product revenue yet; operations remain pre-commercialization, keeping bottom line negative; GAAP net loss $6.6M, driven by operating loss and non-cash derivative fair value changes post-approval.
• Non-cash increase in fair value of Royalty-Linked Notes upon approval and passage of time added $2.0M to Q4 derivative adjustments, dampening GAAP earnings optics.
• G&A rose to $2.1M in Q4 (vs. $1.7M prior year) on higher legal fees, and milestone economics: $20M Pfizer note accrues 8% interest until paid.

Transcript

Operator (participant)

Hello everyone and welcome to the Iterum Therapeutics fourth quarter and full year 2024 financial results. My name is Ezra and I will be your coordinator today. If you would like to ask a question, please press star followed by one on your telephone keypad. If you change your mind, please press star followed by two. I will now hand you over to Louise Barrett, Senior Vice President, Legal Affairs, to begin. Louise, please go ahead.

Louise Barrett (SVP Legal Affairs)

Thank you, Ezra. Good morning and welcome to Iterum Therapeutics fourth quarter and full year 2024 financial results and business update conference call. A press release with our fourth quarter and full year 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 to 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 Orlinva, the sufficiency of our cash resources to fund operating expenses into the second half of 2025, our strategic process to sell, license, or otherwise dispose of our rights to Orlinva, our ability to complete pre-commercialization activities for Orlinva, our ability to develop a commercial launch plan either directly or with a commercial partner if we are unsuccessful at entering into or completing a strategic transaction, 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, effects, and results of our evaluation of strategic alternatives, including the terms, timing, structure, value, benefits, and costs of any strategic alternative, our ability to complete a strategic alternative transaction, our ability to raise sufficient capital and successfully prepare and implement commercialization plans for Orlinva with a commercial partner or directly if we are unsuccessful at entering into or completing a strategic transaction.

The market opportunity for and the potential market acceptance of Orlinva, our ability to continue with the going concern, the accuracy of our expectations regarding how far into the future our cash can handle, fund our ongoing operations, and other factors discussed under the captioned 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 have 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.

Corey Fishman (CEO)

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 Iterum. In January, we generated positive results in our pivotal phase 3 ReAssure clinical trial comparing oral sulopenem to Augmentin in adult women with uncomplicated urinary tract infections. We very efficiently pulled together our NDA resubmission, which was submitted in April. In September, we had a successful advisory committee meeting and in October of 2024, received FDA approval for Orlinva, the brand name for our oral sulopenem bilayer product. Orlinva is indicated for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms E. coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

Orlinva is the first and only approved oral penem in the United States. Now, I'll share a few comments with you as to why we are so excited about the potential for Orlinva in the market. The uncomplicated urinary tract infection market in the US is quite large and generates an estimated 40 million prescriptions annually. Orlinva is the first and only oral penem approved in the United States and the second FDA approved treatment for uncomplicated urinary tract infections in the past two decades. Orlinva will potentially be the first branded product to enter the uncomplicated urinary tract infection market in over 25 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 20%, and those rates can run as high as 30%. 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 is 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 Orlinva 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 is most at risk given their profiles, and many physicians are challenged to treat these patients with existing oral options 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 clinical trial, completed last year and conducted exclusively in the U.S., across almost 1,000 patients, we found that approximately 1% of these patients had an isolate that was resistant to all available oral antibiotics. Orlinva 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, Orlinva has market exclusivity for a total of 10 years from the date of approval or until October 25th, 2034.

Additionally, our US patent portfolio provides protection for Orlinva into 2039, with issued US patents covering both method of use and composition of matter. I've submitted patent information for four US patents for Orlinva that are listed in FDA's Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations. Overall, we're very pleased with the amount of protection that Orlinva should have in the US market to capture value without competition from a potential generic product. In addition to the in-licensed and issued patents we have, there are a number of pending patent applications in the US 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 Orlinva with the goal of maximizing value for our stakeholders.

Along with our financial advisor, 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 Orlinva, which may include seeking to raise capital to support the commercialization of Orlinva.

We plan to engage in pre-commercial activities in order to develop the foundation for a highly targeted launch of Orlinva 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 end of 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 2025. Now I'll turn the call over to Judy Matthews, our CFO, for a financial update.

Judy Matthews (CFO)

Thanks, Corey. Total operating expenses were $3.7 million in the fourth quarter and $18.7 million for the full year 2024, compared to $11.4 million and $47.5 million 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&D costs were $1.3 million for the fourth quarter and $10.5 million for the full year 2024, compared to $9.7 million and $40 million for the same periods in 2023. The primary driver of the decrease in R&D expense for the fourth quarter and full year was the completion of the ReAssure trial. G&A costs were $2.1 million for the fourth quarter and $8 million for the full year 2024, compared to G&A costs of $1.7 million and $7.5 million for the same periods in 2023.

The primary driver of the increase in G&A expense for the fourth quarter and full year was higher legal fees. Our net loss on a US GAAP basis was $6.6 million for the fourth quarter of 2024 and $4.8 million for the full year. On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $3.1 million and $17.6 million for the fourth quarter and full year 2024, compared to our non-GAAP net loss of $10.7 million and $43.8 million for the fourth quarter and full year 2023. The $7.6 million and $26.2 million decrease in our non-GAAP net loss for the fourth quarter and full year was primarily a result of lower R&D expenses related to our ReAssure trial. At the end of December, we had cash and cash equivalents of $24.1 million.

Based on our current operating plan, which includes our currently planned pre-commercialization spend, we expect that our cash and cash equivalents, including $4.8 million of net proceeds raised under our ATM from January 1 through February 6, 2025, will be sufficient to fund our operations into the second half of 2025. Pursuant to our exclusive license with Pfizer for sulopenem, we were obligated to make a regulatory milestone payment of $20 million to Pfizer upon approval of oral sulopenem. 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 million in October 2024. This note accrues interest at an annual rate of 8% on a daily compounded basis until paid in full. On January 31, 2025, we repaid the outstanding principal and interest due under the exchangeable notes in accordance with their terms.

As of February 6th, 2025, we had approximately $34.6 million ordinary shares outstanding. We will now open it up for questions.

Operator (participant)

Thank you very much. If you would like to ask a question, please press Star followed by One on your telephone keypad now. Please ensure your device is unmuted locally. If you change your mind or your question has already been answered, please press Star followed by Two. Our first question comes from Ed Arce with H.C. Wainwright. Ed, your line is now open. Please go ahead.

Thomas Yip (Equity Research Analyst)

Hello, good morning, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you so 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 have any discussions with, such as pharma companies or financial organizations. What type of partners are you seeking out currently?

Corey Fishman (CEO)

Thanks for the question, Thomas. As you'd imagine, we really can't talk in detail about any ongoing conversations. What I will say, as 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.

Thomas Yip (Equity Research Analyst)

Understood. On the other side, you mentioned that there are pre-commercial preparations that are ongoing. Wonder if you can highlight some activities on that front.

Corey Fishman (CEO)

Yep. We are currently engaging in some research with payers, with physicians. We're also doing some analytics around targeting, around geographies, all in the stead 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 Iterum?

Thomas Yip (Equity Research Analyst)

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

Corey Fishman (CEO)

Thanks, Thomas.

Operator (participant)

Thank you very much. Just as a reminder, if you would like to ask a question, please press Star followed by One on your telephone keypad now. We currently have no more questions. I will hand back over to Corey Fishman for any closing remarks.

Corey Fishman (CEO)

Thank you. We appreciate you joining us today. 2024 was a pivotal year for Iterum as we received our FDA approval for Orlinva, the first and only oral penem approved in the U.S. We 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 Orlinva entering the U.S. market and ensuring that Orlinva 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.

Operator (participant)

Thank you very much, Corey, and thank you all our speakers on today's call. This concludes today's conference call. You may now disconnect your lines.