Q3 2025 Iterum Therapeutics PLC Earnings Call
Speaker #1: Hello, and welcome, everyone, to the Iterum Therapeutics third quarter 2025 financial results. My name is Becky, and I will be your operator today. All lines will be muted throughout the presentation portion of the call, with a chance for Q&A at the end.
Speaker #1: If you wish to ask a question at this time, please press star followed by one on your telephone keypads. I will now hand over to your host, Kevin Dalton, Senior Director of Legal Affairs, to begin.
Speaker #1: Please go ahead.
Speaker #2: Thank you, Speaker. Good morning, and welcome to Iterum Therapeutics' third quarter 2025 financial results. A press release with our third quarter results was issued earlier this morning and can be found on our website.
Speaker #2: We are joined this morning by our Chief Executive Officer, Corey Fishman; our Chief Financial Officer, Judith Matthews; and our Chief Commercial Officer, Christine Coyne.
Speaker #2: Corey and Christine will provide an update on the commercial launch of our limber in the U.S. Corey will also give an update on the business generally, and Judy will provide details on our financial results.
Speaker #2: We will then 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.
Speaker #2: Including our expectation that our limber 2026 net product sales will be in a range between 5 and 15 million dollars, the sufficiency of our cash resources to fund our operating expenses into Q2 2026, our ability to continue the commercialization of our limber in the US, our ability to expand into new territories and put additional resources in high-prescribing geographies, and to expand the payer coverage of our limber in the US, our ability to raise funds either through a capital raise and/or revenue generated from sales of our limber, the development therapeutic and market potential of our limber, and the protection provided by our patents.
Speaker #2: Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our control. These include our ability to build and maintain a sales force and continue the commercialization of our limber in the US, the market opportunity for our potential market acceptance of our limber, the actions of third-party suppliers, manufacturers, and contract sales organizations.
Speaker #2: 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 factors discussed under the caption risk factors in our annual report on Form operations, and finally, other 10Q filed with the SEC this morning.
Speaker #2: only as of the date of this call and should statements represent our views not be relied upon as representing our views as of any subsequent date.
Speaker #2: 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.
Speaker #2: With that all said, I'll turn it over now to you, Corey, for your opening.
Speaker #2: remarks.
Speaker #3: Thank
Speaker #3: you, Kevin. Welcome to everyone, and thank you for joining us today. We're excited to be talking with you today and especially looking forward to sharing information about the early stages of the our limber commercialization.
Speaker #3: Just a reminder, we launched our limber into the market on August 20th of this year. Now, I'd like to turn the call over to our Chief Commercial Officer, Christine Coyne.
Speaker #1: Thank you, Corey, and good morning to everyone. As with nearly every new product launch, changing behaviors and old habits is paramount—particularly in a category where prescribing habits have been ingrained for decades due to a lack of innovation and limited new branded options.
Speaker #1: Changing healthcare provider behavior involves frequent office visits, and getting time with those prescribers and their office staff. Our field team has been calling on our providers and ensuring they remember that there is now a better way to help treat their uncomplicated urinary tract infection patients with our limber.
Speaker #1: As with any promotion, message retention and behavior change increases over time and with frequency. That is our current focus with our customers. Each week, this improves.
Speaker #1: Having said that, we made steady progress in educating providers about our limber and driving early our limber use among patients suffering from uncomplicated urinary tract infections, especially in the most recent weeks.
Speaker #1: Our momentum with customers has been growing. Through November, we generated more than 280 prescriptions, which were driven by more than 100 unique prescribers.
Speaker #1: Nearly half of those prescribers have broadened their experience by prescribing our Limber to more than one. This is an important signal of patient experience with our Limber.
Speaker #1: As physician comfort with our limber continues to grow, we have seen a number of these physicians broadening out their use especially in the most recent weeks.
Speaker #1: Another important indicator which we follow closely is the fill rate of the our limber prescriptions through our specialty pharmacy partner. This step in the process has a few parts to it.
Speaker #1: With new product introductions in many instances, payers have yet to make their decisions on formulary inclusion. Which provides coverage for patients. That said, there is usually a path forward to help these insured patients get their prescription, and we are working our way through all of this now.
Speaker #1: As with a large proportion of launches, once payer decisions are made and coverage and access are achieved, this fill rate should improve. However, even during this period of launch, while awaiting payer coverage, we have found that approximately 40% of our limber prescriptions have gone through these payer approval processes and met our expectations.
Speaker #1: As for the patients out of pocket exposure, we have a copay support program that helps been filled. Which aligns with commercial patients. While this may be of help to some with insurance carriers patients, it is our intention to work access to and coverage of our limber to help optimize this adjudication process and patient out of pocket exposure over time.
Speaker #1: We will discuss more on our progress here in just a moment. With the our limber promotion gaining momentum each week, we have received a number of inquiries from physicians interested in obtaining our limber to whom the specialty pharmacy distribution is outside of their business practice model.
Speaker #1: Given the number and frequency of inquiries such as these, we have been working with two of the most widely used specialty distributors: McKesson and Sencora, to talk to these particular physicians' ways of practicing.
Speaker #1: This specialty distribution model allows these physicians to purchase our limber through their preferred distributor, and it supports how they like to practice. At this time, we have already shipped our limber to McKesson, and we will be shipping our limber to Sencora shortly.
Speaker #1: Customer feedback and insights continue to be received as our efforts expand weekly to a wider set of healthcare providers and as utilization deepens with those providers who have already prescribed our limber.
Speaker #1: Some of the important learnings include: physicians welcome our limber as a new alternative for physicians to help treat their uncomplicated urinary tract infection patients effectively.
Speaker #1: challenge. Physicians can clearly see a place for our limber to help them break the But especially where resistance is a cycle of patients being treated with multiple antibiotics which have been resistant.
Speaker #1: Our limber provides physicians with a new option. Additionally, our customers have reported the importance of our limber in helping them keep their patients out of the hospital.
Speaker #1: Being able to treat with a new oral option that helps keep their patients at home has been reported of great importance by our physicians.
Speaker #1: Also, physicians' clinical experience with our limber and their patients has. And as expected. Lastly, customer feedback coming from our recent presence at the infectious disease week conference, which was held last month in Atlanta, our efforts included a poster session of learning lab presentations confirmed very high interest from both key thought leaders and large infectious disease group practices with requests for follow-up discussions.
Speaker #1: Overall, we are pleased with the steady progress we have made particularly given the modest commercial infrastructure we currently have in place. The field team continues working with healthcare providers as trial and adoption of our limber continues.
Speaker #1: Now, regarding our field operations, we continually monitor an array of performance metrics to help us capitalize on opportunities quickly as we discover them, as well as optimize areas where effectiveness needs to be improved.
Speaker #1: Based on these diagnostics, we reduce the in-person field team to 10 representatives from our original plan of 20 and are in the process of augmenting our efforts with both in-person and virtual sales representatives.
Speaker #1: Once fully in place, the combination of the existing resources and our new supplemental resources should provide Iterum the equivalent coverage in at least the initial 20 target geographies if not more and it will be done with greater efficiency.
Speaker #1: Now, I'd like to spend a few moments talking about managed care and market access. Discussions are advancing well with overall Iterum's coverage with pharmacy benefit managers and health plans across both their commercial and Medicare Part D formularies.
Speaker #1: Iterum's national strategically with key account managers continue to engage stakeholders across the US payer landscape or limber's differentiated value proposition and ongoing formulary discussions with state, regional, and national health plans including the three largest pharmacy benefit managers have been met with strong interest and positive feedback.
Speaker #1: Today, we are pleased to announce that we have a signed rebate agreement with one of the top three Medicare Part D pharmacy benefit managers.
Speaker #1: This agreement enables our limber to be added to their Medicare Advantage prescription drug plan and Medicare prescription drug plan formularies for coverage beginning in 2026 or 2027 depending upon the individual plan structures.
Speaker #1: Also, Iterum has been invited to bid for formulary inclusion across commercial, Medicare Part D, and government segments managed by these pharmacy benefit managers. With submissions now complete, we are aiming to secure long-term formulary positioning later this year and into Q1, 2026.
Speaker #1: Our limber's access continues to grow with or without prior authorization or medical exception pathways. Coverage now reaches 16% of insured lives with increasing adoption by employer groups and payer formularies integrating our limber into their standard benefit designs.
Speaker #1: We expect additional decisions in the coming quarters and continue to see an increase in patient access and early prescription growth, reinforcing our confidence in the commercial trajectory.
Speaker #1: Now, I'd like to turn it back over to Corey. Thank
Speaker #1: Thank you for the update on our limber's.
Speaker #2: commercialization, Christine. I'll make a few additional remarks. With regard to our patent estate, we continue to been granted a patent in China that covers a combination of psilocinamethydroxyl, probenecid, and valproic acid for treating specified diseases.
Speaker #2: This patent is expected to expire in March 2041, absent any patent term extensions. We have also been granted a patent in Mexico that covers a bilayer tablet comprising psilocybin methoxy and probenecid, methods of preparing the tablet, and the bilayer tablet for use in treating specified diseases.
Speaker #2: This patent is projected to expire in December 2039, absent any patent term extensions. I now would like to provide some financial guidance. As you may have seen in our financial statements, Iterum generated net product sales of $400,000 in the third quarter which included some stocking at our specialty pharmacy.
Speaker #2: We expect modest sales in the fourth quarter of this year as well. As we look ahead to 2026, with our existing field organization continuing to call on their targets, the additional resources we plan to add that Christine mentioned earlier as well as obtaining coverage in key pharmacy benefit manager insurance plans we currently expect our full year 2026 net product revenue to be in a range between $5 million and $15 million.
Speaker #2: It's important to note that if Iterum were to achieve this revenue guidance for next year, it will have done so with a modest field organization relative to other antibiotic launches in the US.
Speaker #2: As it relates to total operating expenses, we currently estimate these will be between $25 and $30 million for the full year 2026. Our existing cash and cash equivalents provide an operating runway into the second quarter of 2026.
Speaker #2: In order to continue commercialization throughout 2026, we will need to raise more capital. We have, and will continue to, discuss potential financing opportunities with available sources of capital, including non-dilutive funding options; however, to date, we have yet to secure a viable transaction.
Speaker #2: As such, we will likely look to obtain approval from our shareholders at an extraordinary general meeting over the coming months to grant our board of directors authority to issue additional shares.
Speaker #2: this approval and raising If we are successful in getting incremental capital, we would use those funds to continue the ongoing our limber commercialization as well as potentially putting additional resources against high-value territories or expand into other highly valuable territories not yet tapped by us course, our goal over the next couple of years is to generate revenue in excess of the amount or both.
Speaker #2: of expenses we have and be self-funding. In summary, the feedback from physicians, payers, and patients has been very good for our limber and we are encouraged by the Of results we've achieved to date.
Speaker #2: If we're successful in raising additional capital, we believe we can continue to drive revenue growth and position our limber for broader market adoption. Now, I'll turn the call over to Judith Matthews for a financial update.
Speaker #2: update.
Speaker #3: Thanks,
Speaker #3: Revenues were $0.4 million in Corey. Net product sales for the third quarter of 2025 included the launch of our limber in the United States in August 2025, which incorporated initial stocking at our specialty pharmacies located in our targeted territories.
Speaker #3: Total operating expenses were $8.1 million in the third quarter of 2025 compared to $4.9 million in the third quarter of 2024. Operating expenses include the cost of sales, the amortization of an intangible asset, research and development expenses, and selling, general, and administrative expenses.
Speaker #3: Cost quarter 2025 was of sales expense for the third $0.02 million in primarily consistent of royalty payments pursuant to our license agreement with Pfizer.
Speaker #3: Note that prior to approval in October 2024, costs incurred for the manufacture of our limber were recorded as research and development expenses. Amortization of intangible assets for the third quarter 2025 was $0.3 million and related to the finite-lived intangible asset recognized in relation to the regulatory milestone payment payable to Pfizer upon approval of our limber by the FDA.
Speaker #3: R&D costs were $1.3 million for the third quarter compared to $3.1 million for the same period in 2024. The primary driver of the decrease in R&D expense for the third quarter was lower chemistry manufacturing and control (CMC)-related expenses.
Speaker #3: Following approval, costs incurred for the manufacture of our limber have been capitalized to inventory. SG&A costs were $6.5 million for the third quarter compared to SG&A costs of $1.8 million.
Speaker #3: For the same period in 2024, the primary driver of the increase in SG&A expense for the third quarter was commercialization activities associated with the August 2025 launch of our limber in the United States.
Speaker #3: Our net loss on a US gap basis was $9 million for the third quarter of 2025 compared to a net loss of $6.1 million for the third quarter of 2024.
Speaker #3: On a non-gap basis, which excludes certain non-cash adjustments, our net loss of $7.3 million in the third quarter 2025 compared to our non-gap net loss of $4.8 million in the third quarter 2024.
Speaker #3: The $2.5 million increase in our non-GAAP net loss for the third quarter was primarily a result of commercialization activities for our limber, partially offset by lower CMC-related expenses.
Speaker #3: At the end of September, we had cash and cash equivalents of $11 million based on our current operating plan, which includes our forecasted sales.
Speaker #3: We expect that our cash and cash equivalents, together with $2.6 million of net proceeds raised under our at-the-market offering program from October 1, 2025, through November 13, 2025, will be sufficient to fund our operations into the second quarter of 2026.
Speaker #3: As of November 13, 2025, we had approximately 52.8 million ordinary shares outstanding. Now, we will open it up for questions.
Speaker #2: Thank you. If you wish to ask a question, please press star followed by one on your telephone keypad now. If you feel your question has been answered or for any reason you would like to remove yourself from the queue, please press star followed by two.
Speaker #2: Please ensure your device is unmuted locally. When preparing to ask your question, we will pause momentarily while we compile the queue. Our first question comes from Ed Uth from West Park Capital.
Speaker #2: open. Please go Your line is now
Speaker #2: ahead.
Speaker #4: Great. Thanks for taking
Speaker #4: my questions and congrats on the initial launch here. A few questions. First of all, appreciate all the detail here with the launch metrics around the commercialization.
Speaker #4: Wondering if this is the specific numbers around patients and prescribers and reps and coverage are data points that you intend to report for the first few quarters of the launch for us to track.
Speaker #4: And related to that, I was wondering if you could discuss the number of actual physician details and also the number of sales regions that you currently plan to continue.
Speaker #4: And I have a follow-up. Thanks.
Speaker #5: Yep. Thanks for the questions, Ed. I'll cover this. The question around the metrics, yes, we do plan to report the kind of the prescriptions, the growth, the number of physicians, the general information so people have a sense of how the launch is going.
Speaker #5: I think at some point, if all goes well and we're generating tons and tons of scripts, we'll do things like most other companies do, which is report the growth quarter over quarter, that kind of thing.
Speaker #5: So we will be more specific in the first couple of quarters till we have some data behind us. And then we'll probably branch out to providing the same information, but maybe not quite as granular.
Speaker #5: With regard to details and territories, we're not talking about specific number of details. What I will tell you is what I think is important.
Speaker #5: We started out—our initial thinking was having 20 territories with high-value targets. And I think with this change in the organization, as Christine mentioned, as well as the supplemental resources we will be putting on, we will be in a position to at least effectively cover 20 of those territories, maybe a little more, but ultimately more efficiently.
Speaker #5: So I think that's probably the range that we'll be in. And again, we'll continue to report that as we do going forward with regard to how our performance.
Speaker #5: is. Great.
Speaker #4: Okay. And then around the guidance for net sales next year, you in your release discussed two particular drivers: payer coverage, which I think you said is currently at 16% of insured lives.
Speaker #4: And uptake I'm wondering if you could give a bit more color or details around those two drivers and in particular with uptake if there's any initial feedback you've gotten from physicians around the product profile of being oral and keeping the patients at home and how that's driving their interest.
Speaker #4: Thanks.
Speaker #5: Sure. So I will cover the second part first, which is the feedback. Feedback from physicians has been very good. I think there's a variety of reasons that physicians are using the product as Christine mentioned.
Speaker #5: One of them is certainly to keep those patients that are most at risk out of the hospital. One of them is when you have recurrent infections, you want to make sure you're treating that infection appropriately since these folks have been on potentially multiple drugs over a short period of time that haven't worked.
Speaker #5: And also the folks who have those comorbidities and who are on that higher end of the risk spectrum, I think physicians see this as an excellent option.
Speaker #5: And we will continue to work with physicians to get that message across. Your other question, I think, was around access and coverage. We are, I think, in a good spot, as most of the folks on this call know.
Speaker #5: You really don't get coverage in the first six months from any plan post-launch. That is just something that the PBMs, the pharmacy benefit managers, generally do not do.
Speaker #5: And so we're approaching that six-month timeframe in kind of February for us. As mentioned, we have submitted bids to all of them.
Speaker #5: So now it's just a question of being able to get on those plans and get coverage, which will make the process even more efficient.
Speaker #5: Even though there is a process in place, of course, where you can get those prescriptions filled, we can make it a more efficient process through the addition of Orlinva to those formularies.
Speaker #5: So I think we're really looking at that as an opportunity to have additional efficiency in the system so more and more scripts can be filled while you're continuing to have strong uptake with these physicians who are physicians that have written multiple scripts prescribing.
Speaker #5: already. And I think that's really an And again, we've got a lot of important metric these places where you haven't had a new because oftentimes, especially in product for many, many years, and we know that this has been that place, 25, 30 years, docs are pretty ingrained in what they're writing.
Speaker #5: And so it does take a few visits to get them to write. And the folks who have written many of them have come back and written again and again and again.
Speaker #5: So I think we're feeling like we've got a real opportunity here to continue that momentum and that's really the drivers for us of how we're arriving at the revenue guidance.
Speaker #4: Thanks so much. I'll jump back in the.
Speaker #4: queue. Thank
Speaker #1: You. Our next question comes from Jason McCarthy from Maxim Group. Your line is now open. Please go ahead.
Speaker #1: ahead. Hi,
Speaker #6: Corey. Nice job of getting things off the ground so far. So just to follow up on the prior question, did I catch it right?
Speaker #6: You expect formulary I guess you submitted bids already. With PBMs in February. Of 2026 or sometime in the first quarter?
Speaker #3: Yeah, we're hoping that's the case. Obviously, we don't have control of that, Jason. But all of our we're doing everything we can on our end to make that as feasible as possible by having our bids already submitted.
Speaker #3: So we have now submitted our bids to all the three big PBMs as well as the big Medicare Part D plans. So as we said, we've secured one contract so far on the Medicare Part D side.
Speaker #3: And so these will hopefully be coming in over the end of this quarter and the first quarter. And that would give us that opportunity to really kind of give an extra boost to the efficiency of the process.
Speaker #6: Is there any effort by Everison or strategy, rather, in terms of advertising or using social media outlets to get to try to drive uptake?
Speaker #6: the word out on Orlinva
Speaker #3: Yeah, it's definitely something we've thought about. We are at this stage, we have put the majority of our investment into the field organization and the materials necessary to support that.
Speaker #3: But it's definitely something that we continue to look at and think about the ways to optimize that social media presence and how we can get that message across, given that we've got that modest infrastructure.
Speaker #6: Okay. Do you plan on—and this might have been covered already—releasing any information on the types of patients that are being treated, in addition to script data down the road?
Speaker #6: I don't know if that data is being accumulated, meaning are they high risk or even further, are there specific types of comorbidities and high-risk aspects to these patients
Speaker #6: to? Yeah, we're not
Speaker #3: going to have a lot of those specifics because that gets into the doctor-patient relationship. I think what we'll end up having is
Speaker #3: prescribing physicians. And we certainly will always be cognizant of who's writing what information can we get from them about the patients and how it's optimize.
Speaker #3: To optimize that, but it's a little bit trickier just because of all the confidentiality around patient information. You can't really know any of the details until you gain access. And to your point, if we find that a name or anything like that of the patient...
Speaker #3: It would really have to be more just anecdotal from the
Speaker #3: docs. Got it.
Speaker #6: And lastly, and this is not really sure the type of answer to expect from this. This is more of a broad-thinking question because I've been doing this for a long time, and I see a lot of one-product companies and drug launches that are slow to start; they're choppy.
Speaker #6: Some people question what that road is going to look like. But my pushback in this case has been that an oral pen has been sought after for decades.
Speaker #6: And it's not just for community infections like urinary tract infections. Do you think people are going to want this oral pen for a variety of things?
Speaker #6: Have you got an inbound interest in getting access to the drug for any kind of...
Speaker #6: infection? Yeah,
Speaker #3: We've gotten a lot of inbound interest from people who aren't on our call list, including those who are infectious disease physicians, etc.
Speaker #3: So I think there's a lot of interest in that. We obviously have a indication that we will promote on. And that is the only thing we'll be talking about.
Speaker #3: But to the extent that there are physicians who call us up and ask for the product, we will absolutely supply it simply because we believe that it's an important piece if a physician's asking for it.
Speaker #3: And that's why we've gone to McKesson and Sencora. Going through a specialty distributor like ours is outside of the kind of business model for these types of physicians who are giving us inbound calls.
Speaker #6: Great. for. Thank you,
Speaker #6: Corey. Thanks,
Speaker #3: Jason. Thank you.
Speaker #1: We have another question from Ed Aussie from Westport Capital. Your line ahead.
Speaker #3: Great. Thanks for taking the follow-up. I just wanted to ask about this effort to augment the now 10 reps with the virtual effort, especially because you've characterized this as at least replacing the other 10 from the original 20 that you had targeted.
Speaker #3: And perhaps a bit more. provide some more detail in terms of the capabilities and the ability to engage with physicians through these different virtual platforms.
Speaker #3: Thanks. Sure. Thanks, Ed. So I want to be really combination of both in-field and virtual to get to that at least 20 effective territories, if not more.
Speaker #3: And so on the clear. We will probably do a seen and you've probably seen this in your experience as well, many companies have used virtual reps who tend to be very virtual side, I think what you have efficient because they are using the same target lists, but they're doing this all virtually.
Speaker #3: So it's all through phone and computer, as opposed to reps who are out there having to drive, having to wait, etc. They can schedule meetings.
Speaker #3: They can be quite a bit more efficient on the interactions with physicians simply because they are sitting at a desk not trying to drive around and find people and/or get in through the office.
Speaker #3: So those people tend to be based on the experience that Eversona has had, as well as a lot of other companies that we've all seen a reputation for being efficient in terms of producing. We have had a very good performance.
Speaker #3: So we believe that those virtual reps can be a very important part of our organization in addition to the in-field reps. I don't want to minimize one or the other because they're both the combination of the two is really going to give us the incredibly important.
Speaker #3: of targets in an effective way and hopefully drive that performance to the place where we're talking about.
Speaker #6: At this point, are
Speaker #6: you considering other
Speaker #3: will continue to look at them. We'll continue to look at historical return on investment for those types of investments But we do think over various companies Okay.
Speaker #3: try to optimize those as best we like ours that have used them. And we'll as mindful as we can about the capital we have.
Speaker #3: And putting it where we believe we're going to get the biggest bang for the buck. And right now, that tends to be the field organization; hopefully, we'll have a little more flexibility if we're successful in raising more capital, to play.
Speaker #3: put some of those other things into And altogether efficient; it's just a question of having that
Speaker #3: flexibility.
Speaker #6: Sounds
Speaker #6: good. Thanks again. And congrats and best of luck as you continue this launch.
Speaker #3: Thank you. Thanks for the
Speaker #1: Thank
Speaker #1: you. This concludes our Q&A questions. session. So I'll hand back over to Corey Fishman for closing remarks.
Speaker #3: Thank you, Becky. In closing, we believe we've made some very solid progress in the first 10 weeks of Orlenva commercialization. Physicians see a place in the market for Orlenva and many physicians have begun prescribing for multiple patients.
Speaker #3: We will continue to work tirelessly toward growing the Orlenva patient base and driving incremental revenues. We really appreciate your support as we continue the Orlenva commercialization and are looking forward to keeping you updated as our key milestones are met.
Speaker #3: Thanks again for joining us today and have a good
Speaker #1: This concludes