Q2 2025 Iterum Therapeutics PLC Earnings Call

Good morning, thank you for attending today's eram. Therapeutics second, quarter, 2025 Financial results in 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 a conference over to Kevin Dalton senior director, legal Affairs, thank you, you may proceed.

Thank you, speaker.

Good morning and welcome again to Israel's. Therapeutics is second quarter, 2025, 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. Corey Fishman and our Chief Financial Officer. Judy Matthews.

Corey will provide some opening remarks to Judy will provide details on our financial results and an update on the finance related, proposals 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 our Linda 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 our Linda, in the US on or around August 202025.

Our ability to expand into new territories and put additional resources in high prescribing geographies. And to expand the payer coverage of our Linda, in the US,

the sufficiency of our current stock of product in the US to satisfy our commercial requirements into the timeline expected.

Our ability to raise funds, either through a capital, raise Andor revenue generated from sales of our Linda, the opportunity to engage in a business development transaction to sell license or otherwise dispose of our rights to sulo penum.

And the protection provided by our patients.

actual results May differ materially from those indicated by these for forward-looking statements as a result of various factors outside of our control, including our ability to successfully prepare and Implement commercialization plans for our Linda with eversana

Our ability to build and maintain a sales force, and complete, the commercial launch of our Linda, on the timeline expected.

The market opportunity for and the potential Market acceptance of our Linda.

The actions of third parties, 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 cloud of the FCC 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 State. We specifically disclaim any obligation to update the statement,

1 Gap. 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 or linva in the US.

While a business development, transaction remains a potential opportunity for rum at any point including during the commercialization phase for Irlanda. We believe that successfully launching or Linda 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 iter room.

Additionally, we have hired an outstanding Chief commercial officer, Christine coin, 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 have 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 ever Sonic commercial team and has already proven to be a tremendous addition to the iter room team.

Now, I'd like to provide our investors with some very exciting updates regarding the commercialization of Orlanda.

We are very pleased to share with you that we expect to launch. Orland VA 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 2/3 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 our Linda'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, Target, Geographic territories.

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 7 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 our Linda,

While still early these payer discussions have resulted in interest in Orlando.

We aim to continue these discussions by providing additional detailed information on the overall value or limit can provide to the payers.

Our ultimate goal is for patients to have access to our Linda 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 1400 and 4,700, per course of treatment, and importantly, at these gross prices, these products. Enjoy very good Market access.

Very importantly, a long working on payer coverage of Orlando and access to the product for patients iter room plans to help deaf Fray 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 or Linda in the treatment of uncomplicated urinary, tract infections.

Speed to therapy, which is the time it takes for a patient to receive or Linda. 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 stunning from the symptoms of an uncomplicated urinary tract infection.

Our goal is to get or Linda 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 pharmacies 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 Orlando.

As you may have seen yesterday, we have executed a commercial Supply agreement with our finished product supplier. ACS dobfar located in Italy.

This agreement also covers supply of pseudo, penum methods. So both drug substance.

PCS do far is a leading manufacturer of IV, pain and products globally. And a number of years ago, we commissioned the construction of a separate tablet in suite at 1 of their facilities to provide, or Linda.

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 ingredients and our commercial product on an ongoing basis subject, to the terms of the agreement.

As a reminder we have excellent expiration dating of our Linda.

With 8 shelf, life of 6 years from the date of manufacturer.

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 time frame.

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 fizer.

The due date of this payment was initially October of 2026 after iterum 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 or Linda or any additional Capital raised to be used to continue to fund the commercialization of Orland Linda.

On the intellectual property front, we have 2 types of protection for Linda Market, exclusivity and patents.

On the market exclusivity front. The FDA has designated or Linda as a qualified. Infectious disease product, for uncomplicated urinary tract infections, and a number of other indications.

In October 2024, upon approval of Orlanda the FDA confirmed in additional 5 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 the FDA has granted for Linda will expire in October 2034.

On the patent front for erinda. We exclusively licensed from fiser, 1 US patent and 3 foreign patents.

Additionally we own 4 us patents 1, Japanese patent, 1, Korean patent to Australian patents. And now 1 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 3 pending US Patent applications and 25 pending form patent applications, which collectively cover uses of pseudo, penum and preventive. And by layer tablets of pseudo, pain method drops. So and for Benes.

With the combination of marketing exclusivity and patent protection, we believe we're Linda will have a very long Runway to create value.

In summary, we are extremely excited to be launching our Linda 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.

Thanks Corey. Total operating expenses, were 5.5 million and the second quarter of 2025 compared to million dollars in the second quarter of 2024.

Operating expenses include cost of sales which is primarily the amortization of an intangible assets, research and development expenses and general and administrative expenses.

R&D costs were $1 million for the second quarter compared to 2.1 million dollars 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 reassured trial.

GNA costs were 4.2 million for the second quarter compared to GNA costs of 1.9 million for the same period in 2024.

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 dollars. For this 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 and our non-gaap net loss. For the second quarter was primarily a result of higher GNA 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 dollars of net proceeds raised under our at the market offering programs 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 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 authorised, share capital of 481 per companies during 2024 and 2025, in 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 break even

Care. When issuing shares.

Additionally, as an Irish company, we are speaking 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 financing is available to us without having a waiver of preemption rights in place. Are more costly and more diluted 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. So if I want 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 speaker-phone, please remember to pick up your handset before asking your questions we will pause you briefly to allow questions to register.

There are no questions registered at this moment. So as a reminder, it is star 1.

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 Linda, and the timing of its availability.

Along with our commercialization partner of Versona, we believe there is a significant need for Orlando in the US on complicated 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 ve 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.

Oh, thank you for your participation and enjoy the rest of your day.