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. I will now hand over to your host, Kevin Dalton, Senior Director of Legal Affairs. Please go ahead.

Thank you, Becky. Good morning, and welcome to Iterum Therapeutics' Third Quarter 2025 Financial Results. The press release with our third-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 N. Fishman, our Chief Financial Officer, Judith M. Matthews, and our Chief Commercial Officer, Christine Coyne. Corey and Christine will provide an update on the commercial launch of Orlynda in the U.S. Corey will also give an update on the business generally, and Judith will provide details on our financial results. 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, our ability to continue the commercialization of Orlynda in the U.S., 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 U.S. Our ability to raise funds either through capital raise and/or revenue generated from sales of Orlynda, the development, therapeutic, and market potential of Orlynda, 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 our control. These include our ability to build and maintain a sales force and continue the commercialization of Orlynda in the U.S., the market opportunity for our potential market acceptance of Orlynda, the actions of third-party suppliers, manufacturers, and contract sales 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, other factors discussed under the caption 'Risk Factors' in our annual report on Form 10-K and 10-Q 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 now to you, Corey, for your opening remarks.

Thank you, Kevin. Welcome to everyone, and thank you for joining us today. We are excited to be talking with you today and especially looking forward to sharing information about the early stages of the Orlynda commercialization. Just to remind you, we launched Orlynda into the market on August 20. Now I'd like to turn the call over to our Chief Commercial Officer, Christine Coyne.

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 lack of innovation and limited new branded options. 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 Orlynda. 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. Having said that, we made steady progress in educating providers about Orlynda and driving early Orlynda use among patients suffering from uncomplicated urinary tract infections, especially in the most recent weeks. Our momentum with customers has been growing consistently. Through November 12, we generated more than 280 prescriptions, which were driven by more than 100 unique prescribers. Nearly half of those prescribers have broadened their experience by prescribing Orlynda to more than one patient. This is an important signal of both physician and patient experience with Orlynda. As physician comfort with Orlynda continues to grow, we have seen a number of these physicians broadening out their use, especially in the most recent weeks. Another important indicator which we follow closely is the fill rate of Orlynda prescriptions through our specialty pharmacy partner. This step in the process has a few parts to it. 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's usually a path forward to help these insured patients get their prescriptions, and we are working our way through all of this now. 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 Orlynda prescriptions have gone through these payer approval processes and have been filled, which aligns with our expectations. As for the patient's out-of-pocket exposure, we have a co-pay support program that helps defray the cost for appropriate commercial patients. While this may be of help to some patients, it is our intention to work with insurance carriers, including Medicare plans, to gain access to and coverage of Orlynda to help optimize this adjudication process and patient out-of-pocket exposure over time. We will discuss more on our progress here in just a moment. With Orlynda promotion gaining momentum each week, we have received a number of inquiries from physicians interested in obtaining Orlynda to whom the specialty pharmacy is outside of their business practice model. 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 AmerisourceBergen, to tuck into these particular physicians' ways of practicing. This specialty distribution model allows these physicians to purchase Orlynda through their preferred distributor and it supports how they like to practice. At this time, we have already shipped Orlynda to McKesson, and we will be shipping Orlynda to AmerisourceBergen shortly. 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 Orlynda. Some of the important learnings include physicians welcoming Orlynda as a new alternative for physicians to help treat their uncomplicated urinary tract infection patients effectively, but especially where resistance is a challenge. Physicians can clearly see a place for Orlynda to help them break the cycle of patients being treated with multiple antibiotics which have been resistant. Orlynda provides physicians with a new option. Additionally, our customers have reported the importance of Orlynda helping them to keep their patients out of the hospital. 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. Also, physicians' clinical experience with Orlynda and their patients has been 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 and a learning lab presentation, confirms very high interest from both key thought leaders and large infection disease group practices with requests for follow-up discussions. 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 Orlynda continues. 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. Based on these diagnostics, we reduced 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. 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. Now I'd like to spend a few moments and talk about managed care and market access. Overall, Iterum coverage discussions are advancing well, with positive feedback from both pharmacy benefit managers and health plans across both their commercial and Medicare Part D formularies. Iterum's national account managers continue to engage strategically with key stakeholders across the U.S. payer landscape. Orlynda'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. 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. This agreement enables Orlynda 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. 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. Orlynda'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 Orlynda into their standard benefit designs. 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. Now I'd like to turn it back over to Corey.

Thanks for the update on Orlynda's commercialization, Christine. I'll make a few additional remarks. With regard to our patent estate, we continue to expand our coverage. We've been granted a patent in China that covers a combination of probenecid and valproic acid for treating specified diseases. 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 sumopenemethodroxil and probenecid, methods of preparing the tablet, and the bilayer tablet for use in treating specified diseases. 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. 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. 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 U.S. As it relates to total operating expenses, we currently estimate these will be between $25 million and $30 million for the full year 2026. Our existing cash and cash equivalents provide an operating runway into 2026. 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, but to date have yet to secure a viable transaction. 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. If we are successful in getting this approval and raising incremental capital, we would use those funds to continue the ongoing Orlynda commercialization as well as potentially putting additional resources against high-value territories or expand into other highly valuable territories not yet tapped by us, or both. Of course, our goal over the next couple of years is to generate revenue in excess of the amount of expenses we have and be self-funding. In summary, the feedback from physicians, payers, and patients has been very good for Orlynda, and we are encouraged by the results we've achieved to date. If we're successful in raising additional capital, we believe we can continue to drive revenue growth and position Orlynda for broader market adoption. Now I'll turn the call over to Judith Matthews for our update.

Thanks, Corey. Net product revenues were $400,000 in 2025 with the launch of Orlynda in the United States in August 2025 and included initial stocking at our specialty pharmacy locations serving our targeted territories. 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 cost of sales, the amortization of an intangible asset, research and development expenses, and selling, general, and administrative expenses. Cost of sales expense for the third quarter of 2025 was $20,000 and primarily consisted of royalty payments pursuant to our license agreement with Pfizer. Note that prior to approval in October 2024, costs incurred for the manufacture of Orlynda were recorded as research and development expenses. Amortization of intangible asset for the third quarter of 2025 was $300,000 and related to the finite-lived intangible assets recognized in relation to the regulatory milestone payment payable to Pfizer upon approval by the FDA. 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 or CMC-related expenses. Following approval, costs incurred for the manufacture of Orlynda 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 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 Orlynda in the United States. Our net loss on a US GAAP basis was $9 million for 2025, compared to a net loss of $6.1 million for 2024. On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss was $7.3 million in the third quarter of 2025 compared to our non-GAAP net loss of $4.8 million in the third quarter of 2024. The $2.5 million increase in our non-GAAP net loss for the third quarter was primarily a result of commercialization activities for Orlynda, partially offset by lower CMC-related expenses. As of September, we had cash and cash equivalents of $11 million. Based on our current operating plan, which includes our forecasted sales, 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 2026. As of November 13, 2025, we had 52.8 million ordinary shares outstanding. Now we will open it up for questions.

Thank you. If you wish to ask a question, please press star followed by one on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. We will pause momentarily while we compile the Q&A roster. Our first question comes from Ed Arce from WestPark Capital. Your line is now open. Please go ahead.

Great. Thanks for taking my questions and congrats on the initial launch here. A few questions. First of all, I appreciate all the detail here with the launch metrics around the commercialization. I am wondering if these specific numbers around patients and prescribers and reps coverage are data points that you intend to report for the first few quarters of the launch for us to track. 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. And I have a follow-up. Thanks.

Yep. Thanks for the questions, Ed. I'll cover this. The question around the metrics, yes, we do plan to report the, you know, the kind of the prescription, the growth, the number of physicians, the general information so people have a sense of how the launch is going. I think at some point, if all goes well and we're generating, you know, 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. 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. 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. 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. 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 is.

Great. 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, 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, you know, the product profile of being oral and keeping the patients at home and how that's driving their interest. Thanks.

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. 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. 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. And we'll continue to work with physicians to get that message across. Your other question, I think, was around, you know, access and coverage. We are, I think, in a good spot as most of the folks on this call know, 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. And so we're approaching that six-month timeframe in kind of February timeframe for us. And as mentioned, we have submitted bids to all of them. 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. 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 Orlynda to those formularies. 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 prescribing. And again, we've got a lot of physicians that have written multiple scripts already. And I think that's really an important metric because oftentimes, especially in these places where you haven't had a new product for many, many years, and we know that this has been that place. Twenty-five, thirty years, docs are pretty ingrained in what they're writing. 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. 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.

Thanks so much. I'll jump back in the queue.

Hi, 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 you expect formulary I guess you submitted this already, with PBMs in February? Of 2026 or sometime in the first quarter?

Yes, we're hoping that's the case. Obviously, we don't have control of that, Jason. But all of our, you know, we're doing everything we can on our end to make that as feasible as possible by having our bids already submitted. 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. 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.

Is there any effort by Iterum or strategy rather in terms of advertising or using social media outlets to get the word out on Orlynda to try to drive uptake?

Yeah. It's definitely something we've thought about. We are, you know, at this stage, we have put the majority of our investment into the field organization and the materials necessary to support that, 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.

Okay. Do you plan on, and I this might have been covered already. Do you plan on in addition to script data down the road, releasing any information on the types of patients that are being treated? I don't know if that data is being accumulated, meaning are they high risk or even further, specific types of comorbidities and high-risk aspects to these patients that you'll gain access to?

Yeah. We're not going to have a lot of those specifics because that, you know, that gets into the doctor-patient relationship. I think what we'll end up having is more anecdotal information from those prescribing physicians. And, you know, we certainly will always be cognizant of who's writing, what information can we get from them about the patients and how it's working, we can optimize? And to your point, if we find that a certain comorbidity has been really important for a number of doctors, you know, we certainly can get that from them through the sales organization. And then figure out a plan to, you know, to optimize that. But it's a little bit trickier just because of all the confidentiality around patient information, and, you know, you can't really know any of the details on the, you know, the name and anything like that of the patient. It would really have to be more just anecdotal from the docs.

Got it. And lastly, and this is not really sure the type of answers you 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 drug launches that they're slow to start, they're choppy. Some people question what that road is going to look like. But my pushback in this case has been, oral has been sought after for decades, and it's not just for community infections, like urinary tract infections. Have you do you think people are going to want this oral pendant for a variety of things? Have you got an inbound interest, in getting access to the drug, for any kind of infection?

Yeah. We've gotten a lot of inbound interest from people that aren't on our call list, that people that we're not covering infectious disease physicians, etcetera. So I think there's a lot of interest in that. You know, we obviously have an indication that we will promote on, and that is, you know, that's the only thing we'll be talking about. 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. And that's why we've gone to McKesson and AmerisourceBergen because going through a specialty distributor like ours is out of the kind of their business model for these types of physicians who are giving us inbound calls. So we obviously are going to be very, very mindful as an organization to stay within our approved indication. But we will certainly respond to physicians' inquiries because that may very well be for uncomplicated UTI. We just we don't know. And a physician has the flexibility to write it for whatever it is they choose to write it for.

Great. Thank you, Corey.

Thank you.

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, and perhaps a bit more. And so I'm wondering if you could provide some more detail in terms of the capabilities and the ability to engage with physicians through these different virtual platforms. Thanks.

Sure. Thanks, Ed. So I want to be really clear. We will probably do a combination of both in-field and virtual, to get to that at least 20 effective territories, if not more. And so on the virtual side, I think what you have seen, and you've probably seen this in your experience as well, many companies have used virtual reps who tend to be very efficient because they are using the same target lists but they're doing this all virtually. So it's all through phone and computer as opposed to reps who are out there having to drive, having to wait, etcetera. They can schedule meetings. 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. So those people tend to be based on the experience that Eversana has had as well as a lot of other companies that we've all spoken to have had a very good reputation of being efficient in terms of producing performance. 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 incredibly important. But we do think the combination of the two is really going to give us the opportunity to reach a lot of targets in an effective way and hopefully drive that performance to the place where we, you know, we are we're talking about.

Okay. At this point, are you considering other marketing channels like medical journals or engagement via social media or other channels like that?

Yeah. I think, you know, what we've talked a lot about with our partners at Eversana is, you know, things like social media tend to be more effective nowadays than the traditional kind of journal ads and things like that. But we will continue to look at them. We'll continue to look at historical return on investment for those types of investments over various companies like ours that have used them. And we'll try to optimize those as best we can. Again, we're trying to be as mindful as we can about the capital we have. 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 put some of those other things into play. And, you know, altogether then, it makes everything more efficient. It's just a question of having that flexibility.

Sounds good. Thanks again, and congrats and best of luck as you continue this launch.

Thanks for the questions.

This concludes our Q&A session. So I'll hand back over to Corey N. Fishman for closing remarks.

Thank you, Becky. In closing, we believe we've made some very solid progress in the first ten weeks of Orlynda commercialization. Physicians see a place in the market for Orlynda, and many physicians have begun prescribing for multiple patients. We will continue to work tirelessly toward growing the Orlynda patient base and driving incremental revenues. We really appreciate your support as we continue the Orlynda commercialization and are looking forward to keeping you updated as our key milestones are met. Thanks again for joining us today and have a good day.

This concludes today's call. Thank you for joining us. You may now disconnect your lines.