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Iterum Therapeutics reported its second-quarter 2025 earnings, revealing an earnings per share (EPS) of -$0.13, slightly missing the forecasted -$0.11. The market reacted negatively, with the stock experiencing a 1.93% dip in pre-market trading. According to InvestingPro data, the company’s financial health score stands at 1.69 (WEAK), reflecting ongoing profitability challenges. The stock’s beta of 2.85 indicates significantly higher volatility compared to the broader market. The company also provided updates on its innovative product launch and strategic initiatives aimed at strengthening its competitive position in the urinary tract infection (UTI) market.
Key Takeaways
- Iterum Therapeutics reported an EPS of -$0.13, missing the forecast by 18.18%.
- The stock saw a 1.93% decrease in pre-market trading following the earnings release.
- The company is launching Orlynda, the first new oral UTI treatment in 25 years.
- Operating expenses increased to $5.5 million from $4 million in the previous year.
Company Performance
Iterum Therapeutics’ performance in Q2 2025 highlighted increased operating expenses, rising to $5.5 million from $4 million in the same quarter last year. The company has been investing heavily in its new product launch, which is expected to position it uniquely in the UTI market—a sector that has seen no new oral treatments in 25 years. Despite the increased expenses, Iterum remains optimistic about its future prospects, driven by strategic partnerships and a robust product pipeline.
Financial Highlights
- Total operating expenses: $5.5 million in Q2 2025 vs. $4 million in Q2 2024.
- R&D costs: $1 million in Q2 2025 vs. $2.1 million in Q2 2024.
- General and administrative costs: $4.2 million in Q2 2025 vs. $1.9 million in Q2 2024.
- Net loss (GAAP): $6.5 million in Q2 2025 vs. $5 million in Q2 2024.
Earnings vs. Forecast
Iterum’s EPS of -$0.13 was below the forecasted -$0.11, representing an 18.18% miss. This minor miss, while not unprecedented, did contribute to the negative market sentiment. InvestingPro analysis reveals the company has been quickly burning through cash, with a negative free cash flow of $14.74 million in the last twelve months. Historically, the company has faced challenges in meeting earnings expectations, which continues to be an area of focus for investors. For deeper insights into Iterum’s financial health and future prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
Market Reaction
The market responded with a 1.93% drop in Iterum’s stock price in pre-market trading. The stock was priced at $0.70 after the earnings announcement, compared to $0.7138 before. InvestingPro data shows the stock has declined by 49.01% over the past six months, with current market capitalization at $33.63 million. Despite these challenges, the company maintains strong liquidity with a current ratio of 2.69, indicating sufficient assets to cover short-term obligations. This decline aligns with the broader market’s cautious approach towards pharmaceutical companies with similar earnings misses.
Outlook & Guidance
Iterum plans to launch Orlynda on August 20, 2025, targeting high-value physician markets across 20 geographic territories. The company forecasts revenue growth in the upcoming quarters, with projections reaching $4.03 million by Q1 2026. While analyst consensus remains cautious, with price targets ranging from $5 to $9, subscribers to InvestingPro can access additional insights through exclusive ProTips and detailed financial metrics that help evaluate the company’s growth potential. Iterum’s strategic focus on the at-risk patient market, which accounts for 26 million prescriptions annually, is expected to drive future growth.
Executive Commentary
CEO Corey Fishman highlighted the significance of Orlynda’s launch: "We believe we will be the first new branded product launched in the uncomplicated urinary tract infection space in over twenty-five years." He also emphasized the company’s strategic goals: "Our ultimate goal is for patients to have access to Orlynda in a majority of key plans."
Risks and Challenges
- Increased operating expenses could strain financial resources if revenue targets are not met.
- Market saturation and competition from existing UTI treatments could impact Orlynda’s market penetration.
- Regulatory hurdles and the need for extensive payer coverage could delay revenue realization.
- The company faces potential challenges from rising antibiotic resistance, which may require additional R&D investments.
Iterum Therapeutics remains focused on its strategic initiatives and product launches, despite the current financial challenges. The company’s leadership is optimistic about leveraging its unique market position to drive long-term growth.
Full transcript - Iterum Therapeutics PLC (ITRM) Q2 2025:
Megan, Moderator: Good morning. Thank you for attending today’s Eran Therapeutics Second Quarter twenty twenty five Financial Results and Business Update Call. My name is Megan, 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.
Kevin Dalton, Senior Director, Legal Affairs, Iterum Therapeutics: Thank you, Speaker. Good morning, and welcome again to Iterum Therapeutics’ second quarter twenty twenty five financial results and 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, Cory Fishman and our Chief Financial Officer, Judy Matthews. Corey will provide some opening remarks, and Judy will provide details on our financial results and an update on the finance related proposal at our upcoming twenty twenty five Annual General Meeting of Shareholders.
And then we will open the lines for Q and 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 Orlynda, including the estimated annual prescriptions from targeted physicians the sufficiency of our cash resources to fund our operating expenses into 2026 our ability to complete commercial launch of Orlynda in The U. S. On or around 08/20/2025 our ability to expand into new territories and put additional resources in high prescribing geographies and to expand the payer coverage of Orlynda in The US, the sufficiency of our current stock of product in The US 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 Orlynda, the opportunity to engage in a business development transaction to sell, license, or otherwise dispose of our rights to pseudopenem, and the protection provided by our patents.
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 Orlynda with Eversana, our ability to build and maintain a sales force and complete the commercial launch of Orlynda on the timeline expected, the market opportunity for and the potential market acceptance of Orlynda 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 10 Q as filed with 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 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.
With that all said, I’ll turn it over to you, Corey, for your opening remarks.
Corey Fishman, Chief Executive Officer, Iterum Therapeutics: 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’s strategy, Iterum will
Judy Matthews, Chief Financial Officer, Iterum Therapeutics: be launching and commercializing Orlynda in The U. S.
Corey Fishman, Chief Executive Officer, Iterum Therapeutics: 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 thirty year career in pharmaceuticals and biotech, Christine has worked across sales, marketing, market access and operations and had P and 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 20, 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 twenty five 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 40,000,000 prescriptions annually in The US. Of those prescriptions, approximately two thirds or about 26,000,000 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 Arlynva’s addressable market as they are likely the patients with limited or no other oral treatment options available and
Judy Matthews, Chief Financial Officer, Iterum Therapeutics: are
Corey Fishman, Chief Executive Officer, Iterum Therapeutics: 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 twenty five 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 write between one and two 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 Orlynda. While still early, these payer discussions have resulted in interest in Orlynda. We aim to continue these discussions by providing additional detailed information on the overall value Orlynda can provide to the payers.
Our ultimate goal is for patients to have access to Orlynda in a majority of key plans. We have set our wholesaler acquisition cost, 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 Orlynda and access to the product for patients, Iterum plans to help defray out 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 Orlinva in the treatment of uncomplicated urinary tract
Megan, Moderator: infections, speed to therapy, which is
Corey Fishman, Chief Executive Officer, Iterum Therapeutics: the time it takes for a patient to receive Orlinva once a physician has written a prescription, uncomplicated 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 Orlynda 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 from 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 Orlinva.
As you may have seen yesterday, we have executed a commercial supply agreement with our finished product supplier, ACS Dabfahr, located in Italy. This agreement also covers supply of pseudopenemethodroxil bulk drug substance. ACS Dabfahr is a leading manufacturer of IV penem products globally. And a number of years ago, we commissioned the construction of a separate tableting suite at one of their facilities to provide Orlynda. We have had a long and extremely productive partnership with ACS Dobfahr 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 Orlynda 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 entrants will likely have a shorter expiration time frame. We have successfully shipped our finished product to The U. S.
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 U. S. Will satisfy our commercial requirements into mid to late twenty twenty six. Another important item that we have previously disclosed was the extension of our $20,000,000 regulatory payment owed to Pfizer.
The due date of this payment was initially October 2026 after Iterum exercised its deferral option, and this payment is now due in October 2029. This has removed a near term financial obligation from next year and allows a greater portion of any revenue generated by Orlinva or any additional capital raised to be used to continue to fund the commercialization of Orlinva. On the intellectual property front, we have two types of protection for Orlynda, market exclusivity and patents. On the market exclusivity front, the FDA has designated Orlynda as a qualified infectious disease product for uncomplicated urinary tract infections and a number of other indications. In October 2024, upon approval of Orlynda, the FDA confirmed an additional five years of market exclusivity under the GAIN Act, resulting in a total of ten years of market exclusivity in The U.
S. From the date of approval. Therefore, the market exclusivity that FDA has granted Orlinva will expire in October 2034. On the patent front for Orlynda, we exclusively license from Pfizer one U. S.
Patent and three foreign patents. Additionally, we own four U. S. 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 02/1941, excluding any additional term for patent adjustments or patent term extensions.
We also own three pending U. S. Patent applications and 25 pending foreign patent applications, which collectively cover uses of solopenem and probenecid and bilayer tablets of solopenem ethidroxil and probenecid. With the combination of marketing exclusivity and patent protection, we believe Orlynda will have a very long runway to create value. In summary, we are extremely excited to be launching Orlynda in the next few weeks and are looking forward to bringing this important new treatment option to physicians and their patients.
Now I’ll turn the call over to Judy Matthews for a financial update.
Judy Matthews, Chief Financial Officer, Iterum Therapeutics: Thanks, Corey. Total operating expenses were $5,500,000 in the 2025 compared to $4,000,000 in the 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 and D costs were $1,000,000 for the second quarter compared to $2,100,000 for the same period in 2024. The primary driver of the decrease in R and D expense for the second quarter was the decrease in costs associated with the ReAssure trial.
G and A costs were $4,200,000 for the second quarter compared to g and A costs of $1,900,000 for the same period in 2024. The primary driver of the increase in g and a expense for the second quarter was pre commercialization activities. Our net loss on a US GAAP basis was $6,500,000 for the 2025 compared to a net loss of $5,000,000 for the 2024. On a non GAAP basis, which excludes certain noncash adjustments, our net loss of $5,100,000 in the 2025 compared to our non GAAP net loss of $3,800,000 in the 2024. The $1,300,000 increase in our non GAAP net loss for the second quarter was primarily a result of higher g and a due to spending on pre commercialization activity.
At the June, we had cash and cash equivalents of $13,000,000. 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 $2,200,000 of net proceeds raised under our aftermarket offering program from July 1 through 08/01/2025 will be sufficient to fund our operations into 2026. As of 08/04/2025, we had approximately 44,700,000.0 ordinary shares outstanding. On September 10, 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 that have gone out that we have requested authorization of an additional 80,000,000 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 financings 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.
Megan, Moderator: Thank you. If 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 2. Again, to ask a question, please press star 1. As a reminder, if you’re using a speakerphone, please remember to pick up your handset 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.
Corey Fishman, Chief Executive Officer, Iterum Therapeutics: Thank you, Menyem. 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 Orlynda and the timing of its availability. Along with our commercialization partner, Eversana, we believe there is a significant need for Orlynda in The U. S.
Uncomplicated urinary tract infection market and are looking forward to providing the first and only approved oral penum in The U. S. 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
Megan, Moderator: call. Thank you for your participation and enjoy the rest of your day.
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