NASDAQ:ITRM Iterum Therapeutics Q3 2025 Earnings Report $0.03 0.00 (0.00%) As of 05/5/2026 ProfileEarnings HistoryForecast Iterum Therapeutics EPS ResultsActual EPS-$0.20Consensus EPS -$0.13Beat/MissMissed by -$0.07One Year Ago EPSN/AIterum Therapeutics Revenue ResultsActual Revenue$0.39 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AIterum Therapeutics Announcement DetailsQuarterQ3 2025Date11/14/2025TimeBefore Market OpensConference Call DateFriday, November 14, 2025Conference Call Time8:30AM ETUpcoming EarningsIterum Therapeutics' Q4 2025 earnings is estimated for Wednesday, May 20, 2026, based on past reporting schedules, with a conference call scheduled on Friday, May 15, 2026 at 9:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Iterum Therapeutics Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 14, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Early launch traction: through November 12 Iterum generated >280 prescriptions from >100 unique prescribers for Orlyvah, with ~40% of scripts filled via the specialty pharmacy, signaling initial physician adoption despite payer constraints. Neutral Sentiment: 2026 guidance: the company expects full‑year net product sales of $5–$15M and forecasts total operating expenses of $25–$30M for 2026. Negative Sentiment: Funding runway and dilution risk: Iterum had $11M cash at Sept 30 plus ~$2.6M ATM proceeds, which management says funds operations into Q2 2026, and it will need to raise additional capital—potentially requiring shareholder approval to issue more shares—to continue commercialization. Positive Sentiment: Managed‑care progress: Iterum signed a rebate agreement with a top‑three Medicare Part D PBM, has submitted bids to major PBMs, and reports coverage reaching ~16% of insured lives, supporting broader access in 2026–2027. Positive Sentiment: Commercial strategy update: the field team was reduced from 20 to 10 in‑person reps and will be augmented with virtual reps plus distribution via McKesson and Cencora to cost‑effectively cover the initial ~20 target territories. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallIterum Therapeutics Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Moderator00:00:00Hello 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. If you wish to ask a question in this time, please press Star, followed by 1 on your telephone keypads. I will now hand over to your host, Kevin Dalton, Senior Director of Legal Affairs, to begin. Please go ahead. Kevin DaltonSenior Director of Legal Affairs at Iterum Therapeutics00:00:30Thank 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. We are joined this morning by our Chief Executive Officer, Corey Fishman, our Chief Financial Officer, Judy Matthews, and our Chief Commercial Officer, Christine Coyne. Corey and Christine will provide an update on the commercial launch of Orlynvah in the United States. Corey will also give an update on the business generally, and Judy will provide details on our financial results. We will then open the lines for Q&A. Kevin DaltonSenior Director of Legal Affairs at Iterum Therapeutics00:01:14Before 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, including our expectation that Orlyvnah 2026 net product sales will be in a range between $5 million and $15 million, the sufficiency of our cash resources to fund our operating expenses into Q2 2026, our ability to continue the commercialization of Orlynvah 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 Orlynvah in the U.S., our ability to raise funds either through a capital raise and/or revenue generated from sales of Orlynvah, the development, therapeutic, and market potential of Orlynvah, and the protection provided by our patents. Kevin DaltonSenior Director of Legal Affairs at Iterum Therapeutics00:02:15Actual 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 Orlynvah in the United States, the market opportunity for and potential market acceptance of Orlynvah, 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 10Q 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. Kevin DaltonSenior Director of Legal Affairs at Iterum Therapeutics00:03:18We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We have provided reconciliation 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. Corey FishmanCEO at Iterum Therapeutics00:03:43Thank 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 Orlynvah commercialization. Just to remind you, we launched Orlynvah 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. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:04:09Thank 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 Orlynvah. 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. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:05:03Having said that, we made steady progress in educating providers about Orlynvah and driving early Orlynvah 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 12th, 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 Orlynvah to more than one patient. This is an important signal of both physician and patient experience with Orlynvah. As physician comfort with Orlynvah 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 the Orlynvah prescriptions through our specialty pharmacy partner. This step in the process has a few parts to it. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:06:12With 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. 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 the Orlynvah prescriptions have gone through these payer approval processes and have been filled, which aligns with our expectations. As for the patients' out-of-pocket exposure, we have a copay support program that helps defray the cost for appropriate commercial patients. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:07:12While 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 Orlynvah 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 the Orlynvah promotion gaining momentum each week, we have received a number of inquiries from physicians interested in obtaining Orlynvah to whom the specialty pharmacy distribution 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 Cencora, to tuck into these particular physicians' ways of practicing. This specialty distribution model allows these physicians to purchase Orlynvah through their preferred distributor, and it supports how they like to practice. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:08:19At this time, we have already shipped Orlynvah to McKesson, and we will be shipping Orlynvah to Cencora 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 Orlynvah. Some of the important learnings include physicians welcomed Orlynvah 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 Orlynvah to help them break the cycle of patients being treated with multiple antibiotics, which have been resistant. Orlynvah provides physicians with a new option. Additionally, our customers have reported the importance of Orlynvah helping them to keep their patients out of the hospital. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:09:27Being 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 Orlynvah and their patients has improved and is 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, a learning lab presentation, confirmed very high interest from both key thought leaders and large infectious 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 Orlynvah continues. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:10:34Now, 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. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:11:33Overall, 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 national account managers continue to engage strategically with key stakeholders across the U.S. payer landscape. Orlynvah'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 Orlynvah 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. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:12:46Also, 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. Orlynvah'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 Orlynvah 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. Thank you. Corey FishmanCEO at Iterum Therapeutics00:13:50Thanks for the update on Orlynvah'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 sulopenem etzadroxil, 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 sulopenem etzadroxil 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. Corey FishmanCEO at Iterum Therapeutics00:15:01We 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 the second quarter of 2026. Corey FishmanCEO at Iterum Therapeutics00:16:09In 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 Orlynvah 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. Corey FishmanCEO at Iterum Therapeutics00:17:24In summary, the feedback from physicians, payers, and patients has been very good for Orlynvah, 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 Orlynvah for broader market adoption. Now I'll turn the call over to Judy Matthews for a financial update. Judy MatthewsCFO at Iterum Therapeutics00:17:49Thanks, Corey. Net product revenues were $0.4 million in the third quarter of 2025 with the launch of Orlynvah in the United States in August 2025 and included initial stocking at our specialty pharmacies' locations serving our targeted territories. Total operating expenses were $8.1 million in the third quarter 2025 compared to $4.9 million in the third quarter 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 2025 was $0.02 million 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 Orlynvah were recorded as research and development expenses. Judy MatthewsCFO at Iterum Therapeutics00:18:56Amortization of intangible asset 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 Orlynvah 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 Orlynvah 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 Orlynvah in the United States. Judy MatthewsCFO at Iterum Therapeutics00:20:04Our net loss on a U.S. GAAP 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. On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $7.3 million in the third quarter 2025 compared to our non-GAAP net loss of $4.8 million in the third quarter 2024. The $2.5 million increase in our non-GAAP net loss for the third quarter was primarily a result of commercialization activities for Orlynvah, partially offset by lower CMC-related expenses. At the end of September, we had cash and cash equivalents of $11 million. Judy MatthewsCFO at Iterum Therapeutics00:20:54Based 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 the second quarter of 2026. As of November 13, 2025, we had approximately 52.8 million ordinary shares outstanding. Now we will open it up for questions. Moderator00:21:32Thank you. If you wish to ask a question, please press Star, followed by 1 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 2. When preparing to ask your question, please ensure your device is unmuted locally. I will pause momentarily while we compile the queue. Our first question comes from Ed Oss from West Park Capital. Your line is now open. Please go ahead. Ed ArceSenior Research Analyst at West Park Capital00:22:20Great. Thanks for taking 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. Wondering if these 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. 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. I have a follow-up. Thanks. Corey FishmanCEO at Iterum Therapeutics00:23:17Yep. 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. 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. 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 a specific number of details. What I will tell you is what I think is important. Corey FishmanCEO at Iterum Therapeutics00:24:15We started out our initial thinking was having 20 territories with high-value targets. 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. I think that's probably the range that we'll be in. Again, we'll continue to report that as we do going forward with regard to how our performance is. Ed ArceSenior Research Analyst at West Park Capital00:24:57Great. Okay. 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. 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. Thanks. Corey FishmanCEO at Iterum Therapeutics00:25:53Sure. 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. 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. 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. Corey FishmanCEO at Iterum Therapeutics00:26:53As 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. We are approaching that six-month timeframe in kind of February timeframe for us. As mentioned, we have submitted bids to all of them. Now it is 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 Orlynvah to those formularies. Corey FishmanCEO at Iterum Therapeutics00:27:38I 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. Again, we've got a lot of physicians that have written multiple scripts already. 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 25-30 years, docs are pretty ingrained in what they're writing. It does take a few visits to get them to write. The folks who have written, many of them have come back and written again and again and again. I think we're feeling like we've got a real opportunity here to continue that momentum. Corey FishmanCEO at Iterum Therapeutics00:28:31That is really the drivers for us of how we're arriving at the revenue guidance. Ed ArceSenior Research Analyst at West Park Capital00:28:41Thanks so much. I'll jump back in the queue. Moderator00:28:46Thank you. Our next question comes from Jason McCarthy from Maxim Group. Your line is now open. Please go ahead. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:28:55Hi, Corey. Nice job of getting things off the ground so far. Just to follow up on the prior question, did I catch it right? You expect formulary, I guess you submitted bids already with PBMs in February of 2026 or sometime in the first quarter? Corey FishmanCEO at Iterum Therapeutics00:29:17Yeah, 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. We have now submitted our bids to all the three big PBMs as well as the big Medicare Part D plans. As we said, we've secured one contract so far on the Medicare Part D side. These will hopefully be coming in over the end of this quarter and the first quarter. That would give us that opportunity to really kind of give an extra boost to the efficiency of the process. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:29:55Is there any effort by EVERSANA or strategy, rather, in terms of advertising or using social media outlets to get the word out on Orlynvah to try to drive uptake? Corey FishmanCEO at Iterum Therapeutics00:30:13Yeah, it's definitely something we've thought about. At this stage, we have put the majority of our investment into the field organization and the materials necessary to support that. 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. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:30:39Okay. Do you plan on—and 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, are there specific types of comorbidities and high-risk aspects to these patients that you'll gain access to? Corey FishmanCEO at Iterum Therapeutics00:31:13Yeah. We're not 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 more anecdotal information from those prescribing physicians. 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 so we can optimize. To your point, if we find that a certain comorbidity has been really important for a number of doctors, we certainly can get that from them through the sales organization and then figure out a plan to optimize that. It's a little bit trickier just because of all the confidentiality around patient information. You can't really know any of the details on the name and anything like that of the patient. It would really have to be more just anecdotal from the docs. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:32:14Got it. 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 they're slow to start, they're choppy. Some people question what that road's going to look like. My pushback in this case has been an oral pen has been sought after for decades. 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? Have you gotten inbound interest in getting access to the drug for any kind of infection? Corey FishmanCEO at Iterum Therapeutics00:33:00Yeah. We've gotten a lot of inbound interest from people that aren't on our call list, people that we're not covering, infectious disease physicians, etc. I think there's a lot of interest in that. We obviously have an indication that we will promote on. That's the only thing we'll be talking about. 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. That's why we've gone to McKesson and Cencora because going through a specialty distributor like ours is out of kind of their business model for these types of physicians who are giving us inbound calls. We obviously are going to be very, very mindful as an organization to stay within our approved indication. Corey FishmanCEO at Iterum Therapeutics00:33:52We will certainly respond to physicians' inquiries because that may very well be for uncomplicated UTI. We don't know. A physician has the flexibility to write it for whatever it is they choose to write it for. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:34:07Great. Thank you, Corey. Corey FishmanCEO at Iterum Therapeutics00:34:09Thanks, Jason. Operator00:34:12Thank you. We have another question from Ed Oss from West Park Capital. Your line is now open. Please go ahead. Ed ArceSenior Research Analyst at West Park Capital00:34:22Great. 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. I am 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. Corey FishmanCEO at Iterum Therapeutics00:35:12Sure. Thanks, Ed. 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. 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. 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. They can be quite a bit more efficient on the interactions with physicians simply because they're sitting at a desk not trying to drive around and find people and/or get in through the office. Corey FishmanCEO at Iterum Therapeutics00:36:08Those 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. We believe that those virtual reps can be a very important part of our organization in addition to the in-field reps. I do not want to minimize one or the other because they're both incredibly important. 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're talking about. Ed ArceSenior Research Analyst at West Park Capital00:36:54Okay. At this point, are you considering other marketing channels like medical journals or engagement via social media or other channels like that? Corey FishmanCEO at Iterum Therapeutics00:37:12Yeah. I think what we've talked a lot about with our partners at EVERSANA is things like social media tend to be more effective nowadays than the traditional kind of journal ads and things like that. 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. 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. 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. Altogether, then it makes everything more efficient. Corey FishmanCEO at Iterum Therapeutics00:38:02It's just a question of having that flexibility. Ed ArceSenior Research Analyst at West Park Capital00:38:07Sounds good. Thanks again and congrats and best of luck as you continue this launch. Corey FishmanCEO at Iterum Therapeutics00:38:15Thanks. Thanks for the questions. Moderator00:38:18Thank you. This concludes our Q&A session. I'll hand back over to Corey Fishman for closing remarks. Corey FishmanCEO at Iterum Therapeutics00:38:25Thank you, Becky. In closing, we believe we've made some very solid progress in the first 10 weeks of Orlynvah commercialization. Physicians see a place in the market for Orlynvah, and many physicians have begun prescribing for multiple patients. We will continue to work tirelessly toward growing the Orlynvah patient base and driving incremental revenues. We really appreciate your support as we continue the Orlynvah 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. Moderator00:39:05This concludes today's call. Thank you for joining us. You may now disconnect your lines.Read moreParticipantsExecutivesKevin DaltonSenior Director of Legal AffairsChristine CoyneChief Commercial OfficerJudy MatthewsCFOCorey FishmanCEOAnalystsJason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim GroupModeratorEd ArceSenior Research Analyst at West Park CapitalPowered by Earnings DocumentsEarnings Release(8-K)Quarterly Report(10-Q) Iterum Therapeutics Earnings HeadlinesHC Wainwright & Co. downgrades Iterum Therapeutics (ITRM)March 31, 2026 | msn.comWhat's going on with Iterum Therapeutics stock Monday?March 30, 2026 | msn.com$30 stock to buy before Starlink goes public (WATCH NOW!)In the next 3 minutes… James Altucher – legendary investor and venture capitalist… And someone who’s known for playing his cards “close to the vest”… Is going to give you the name and ticker symbol of a company he believes will skyrocket thanks to the coming Starlink IPO… | Paradigm Press (Ad)Iterum files wind-up petition due to limited cash, inability to raise equityMarch 27, 2026 | reuters.comIterum Therapeutics Announces Filing of Winding Up PetitionMarch 27, 2026 | globenewswire.comIterum Therapeutics (ITRM) price target increased by 63.64% to 9.18March 27, 2026 | msn.comSee More Iterum Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Iterum Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Iterum Therapeutics and other key companies, straight to your email. Email Address About Iterum TherapeuticsIterum Therapeutics (NASDAQ:ITRM) is a clinical-stage biopharmaceutical company focused on the development and commercialization of anti-infective products targeting drug-resistant bacterial infections. The company’s research efforts are centered on novel therapeutic agents designed to address serious community-acquired and hospital-acquired infections where current treatment options are limited by emerging resistance. The company’s lead product candidate, sulopenem, is being evaluated in both intravenous and oral formulations for the treatment of complicated urinary tract infections (cUTI) and intra-abdominal infections (IAI). Iterum’s development strategy seeks to leverage the broad spectrum of activity exhibited by sulopenem against resistant Gram-negative pathogens, with the goal of offering a seamless transition from hospital to outpatient care via its oral formulation. Incorporated in 2014 and headquartered in Dublin, Ireland, Iterum Therapeutics maintains additional operations in the United States, including a presence in Malvern, Pennsylvania, to support clinical and regulatory activities. The company is backed by a management team and board with extensive experience in anti-infective drug discovery, clinical development and life-cycle management. Iterum continues to advance its pipeline through ongoing regulatory interactions and clinical studies aimed at meeting unmet medical needs in infectious diseases.View Iterum Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Boarding Passes Now Being Issued for the Ultimate eVTOL ArbitrageDigitalOcean’s AI Surge: How Far Can This Rally Go?Years in the Making, AMD’s Upside Movement Has Just BegunCapital One’s Big Bet Faces Rising Credit RiskWestern Digital: The Storage Behemoth Skyrocketing on AI DemandOld Money, New Tech: Western Union's Crypto RebootHow Williams Companies Is Cashing in on the AI Power Boom Upcoming Earnings Brookfield Asset Management (5/8/2026)Enbridge (5/8/2026)Toyota Motor (5/8/2026)Ubiquiti (5/8/2026)Constellation Energy (5/11/2026)Barrick Mining (5/11/2026)Petroleo Brasileiro S.A.- Petrobras (5/11/2026)Simon Property Group (5/11/2026)SEA (5/12/2026)Cisco Systems (5/13/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
PresentationSkip to Participants Moderator00:00:00Hello 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. If you wish to ask a question in this time, please press Star, followed by 1 on your telephone keypads. I will now hand over to your host, Kevin Dalton, Senior Director of Legal Affairs, to begin. Please go ahead. Kevin DaltonSenior Director of Legal Affairs at Iterum Therapeutics00:00:30Thank 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. We are joined this morning by our Chief Executive Officer, Corey Fishman, our Chief Financial Officer, Judy Matthews, and our Chief Commercial Officer, Christine Coyne. Corey and Christine will provide an update on the commercial launch of Orlynvah in the United States. Corey will also give an update on the business generally, and Judy will provide details on our financial results. We will then open the lines for Q&A. Kevin DaltonSenior Director of Legal Affairs at Iterum Therapeutics00:01:14Before 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, including our expectation that Orlyvnah 2026 net product sales will be in a range between $5 million and $15 million, the sufficiency of our cash resources to fund our operating expenses into Q2 2026, our ability to continue the commercialization of Orlynvah 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 Orlynvah in the U.S., our ability to raise funds either through a capital raise and/or revenue generated from sales of Orlynvah, the development, therapeutic, and market potential of Orlynvah, and the protection provided by our patents. Kevin DaltonSenior Director of Legal Affairs at Iterum Therapeutics00:02:15Actual 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 Orlynvah in the United States, the market opportunity for and potential market acceptance of Orlynvah, 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 10Q 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. Kevin DaltonSenior Director of Legal Affairs at Iterum Therapeutics00:03:18We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We have provided reconciliation 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. Corey FishmanCEO at Iterum Therapeutics00:03:43Thank 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 Orlynvah commercialization. Just to remind you, we launched Orlynvah 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. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:04:09Thank 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 Orlynvah. 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. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:05:03Having said that, we made steady progress in educating providers about Orlynvah and driving early Orlynvah 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 12th, 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 Orlynvah to more than one patient. This is an important signal of both physician and patient experience with Orlynvah. As physician comfort with Orlynvah 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 the Orlynvah prescriptions through our specialty pharmacy partner. This step in the process has a few parts to it. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:06:12With 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. 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 the Orlynvah prescriptions have gone through these payer approval processes and have been filled, which aligns with our expectations. As for the patients' out-of-pocket exposure, we have a copay support program that helps defray the cost for appropriate commercial patients. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:07:12While 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 Orlynvah 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 the Orlynvah promotion gaining momentum each week, we have received a number of inquiries from physicians interested in obtaining Orlynvah to whom the specialty pharmacy distribution 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 Cencora, to tuck into these particular physicians' ways of practicing. This specialty distribution model allows these physicians to purchase Orlynvah through their preferred distributor, and it supports how they like to practice. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:08:19At this time, we have already shipped Orlynvah to McKesson, and we will be shipping Orlynvah to Cencora 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 Orlynvah. Some of the important learnings include physicians welcomed Orlynvah 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 Orlynvah to help them break the cycle of patients being treated with multiple antibiotics, which have been resistant. Orlynvah provides physicians with a new option. Additionally, our customers have reported the importance of Orlynvah helping them to keep their patients out of the hospital. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:09:27Being 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 Orlynvah and their patients has improved and is 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, a learning lab presentation, confirmed very high interest from both key thought leaders and large infectious 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 Orlynvah continues. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:10:34Now, 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. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:11:33Overall, 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 national account managers continue to engage strategically with key stakeholders across the U.S. payer landscape. Orlynvah'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 Orlynvah 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. Christine CoyneChief Commercial Officer at Iterum Therapeutics00:12:46Also, 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. Orlynvah'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 Orlynvah 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. Thank you. Corey FishmanCEO at Iterum Therapeutics00:13:50Thanks for the update on Orlynvah'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 sulopenem etzadroxil, 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 sulopenem etzadroxil 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. Corey FishmanCEO at Iterum Therapeutics00:15:01We 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 the second quarter of 2026. Corey FishmanCEO at Iterum Therapeutics00:16:09In 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 Orlynvah 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. Corey FishmanCEO at Iterum Therapeutics00:17:24In summary, the feedback from physicians, payers, and patients has been very good for Orlynvah, 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 Orlynvah for broader market adoption. Now I'll turn the call over to Judy Matthews for a financial update. Judy MatthewsCFO at Iterum Therapeutics00:17:49Thanks, Corey. Net product revenues were $0.4 million in the third quarter of 2025 with the launch of Orlynvah in the United States in August 2025 and included initial stocking at our specialty pharmacies' locations serving our targeted territories. Total operating expenses were $8.1 million in the third quarter 2025 compared to $4.9 million in the third quarter 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 2025 was $0.02 million 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 Orlynvah were recorded as research and development expenses. Judy MatthewsCFO at Iterum Therapeutics00:18:56Amortization of intangible asset 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 Orlynvah 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 Orlynvah 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 Orlynvah in the United States. Judy MatthewsCFO at Iterum Therapeutics00:20:04Our net loss on a U.S. GAAP 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. On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $7.3 million in the third quarter 2025 compared to our non-GAAP net loss of $4.8 million in the third quarter 2024. The $2.5 million increase in our non-GAAP net loss for the third quarter was primarily a result of commercialization activities for Orlynvah, partially offset by lower CMC-related expenses. At the end of September, we had cash and cash equivalents of $11 million. Judy MatthewsCFO at Iterum Therapeutics00:20:54Based 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 the second quarter of 2026. As of November 13, 2025, we had approximately 52.8 million ordinary shares outstanding. Now we will open it up for questions. Moderator00:21:32Thank you. If you wish to ask a question, please press Star, followed by 1 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 2. When preparing to ask your question, please ensure your device is unmuted locally. I will pause momentarily while we compile the queue. Our first question comes from Ed Oss from West Park Capital. Your line is now open. Please go ahead. Ed ArceSenior Research Analyst at West Park Capital00:22:20Great. Thanks for taking 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. Wondering if these 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. 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. I have a follow-up. Thanks. Corey FishmanCEO at Iterum Therapeutics00:23:17Yep. 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. 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. 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 a specific number of details. What I will tell you is what I think is important. Corey FishmanCEO at Iterum Therapeutics00:24:15We started out our initial thinking was having 20 territories with high-value targets. 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. I think that's probably the range that we'll be in. Again, we'll continue to report that as we do going forward with regard to how our performance is. Ed ArceSenior Research Analyst at West Park Capital00:24:57Great. Okay. 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. 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. Thanks. Corey FishmanCEO at Iterum Therapeutics00:25:53Sure. 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. 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. 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. Corey FishmanCEO at Iterum Therapeutics00:26:53As 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. We are approaching that six-month timeframe in kind of February timeframe for us. As mentioned, we have submitted bids to all of them. Now it is 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 Orlynvah to those formularies. Corey FishmanCEO at Iterum Therapeutics00:27:38I 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. Again, we've got a lot of physicians that have written multiple scripts already. 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 25-30 years, docs are pretty ingrained in what they're writing. It does take a few visits to get them to write. The folks who have written, many of them have come back and written again and again and again. I think we're feeling like we've got a real opportunity here to continue that momentum. Corey FishmanCEO at Iterum Therapeutics00:28:31That is really the drivers for us of how we're arriving at the revenue guidance. Ed ArceSenior Research Analyst at West Park Capital00:28:41Thanks so much. I'll jump back in the queue. Moderator00:28:46Thank you. Our next question comes from Jason McCarthy from Maxim Group. Your line is now open. Please go ahead. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:28:55Hi, Corey. Nice job of getting things off the ground so far. Just to follow up on the prior question, did I catch it right? You expect formulary, I guess you submitted bids already with PBMs in February of 2026 or sometime in the first quarter? Corey FishmanCEO at Iterum Therapeutics00:29:17Yeah, 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. We have now submitted our bids to all the three big PBMs as well as the big Medicare Part D plans. As we said, we've secured one contract so far on the Medicare Part D side. These will hopefully be coming in over the end of this quarter and the first quarter. That would give us that opportunity to really kind of give an extra boost to the efficiency of the process. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:29:55Is there any effort by EVERSANA or strategy, rather, in terms of advertising or using social media outlets to get the word out on Orlynvah to try to drive uptake? Corey FishmanCEO at Iterum Therapeutics00:30:13Yeah, it's definitely something we've thought about. At this stage, we have put the majority of our investment into the field organization and the materials necessary to support that. 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. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:30:39Okay. Do you plan on—and 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, are there specific types of comorbidities and high-risk aspects to these patients that you'll gain access to? Corey FishmanCEO at Iterum Therapeutics00:31:13Yeah. We're not 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 more anecdotal information from those prescribing physicians. 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 so we can optimize. To your point, if we find that a certain comorbidity has been really important for a number of doctors, we certainly can get that from them through the sales organization and then figure out a plan to optimize that. It's a little bit trickier just because of all the confidentiality around patient information. You can't really know any of the details on the name and anything like that of the patient. It would really have to be more just anecdotal from the docs. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:32:14Got it. 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 they're slow to start, they're choppy. Some people question what that road's going to look like. My pushback in this case has been an oral pen has been sought after for decades. 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? Have you gotten inbound interest in getting access to the drug for any kind of infection? Corey FishmanCEO at Iterum Therapeutics00:33:00Yeah. We've gotten a lot of inbound interest from people that aren't on our call list, people that we're not covering, infectious disease physicians, etc. I think there's a lot of interest in that. We obviously have an indication that we will promote on. That's the only thing we'll be talking about. 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. That's why we've gone to McKesson and Cencora because going through a specialty distributor like ours is out of kind of their business model for these types of physicians who are giving us inbound calls. We obviously are going to be very, very mindful as an organization to stay within our approved indication. Corey FishmanCEO at Iterum Therapeutics00:33:52We will certainly respond to physicians' inquiries because that may very well be for uncomplicated UTI. We don't know. A physician has the flexibility to write it for whatever it is they choose to write it for. Jason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim Group00:34:07Great. Thank you, Corey. Corey FishmanCEO at Iterum Therapeutics00:34:09Thanks, Jason. Operator00:34:12Thank you. We have another question from Ed Oss from West Park Capital. Your line is now open. Please go ahead. Ed ArceSenior Research Analyst at West Park Capital00:34:22Great. 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. I am 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. Corey FishmanCEO at Iterum Therapeutics00:35:12Sure. Thanks, Ed. 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. 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. 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. They can be quite a bit more efficient on the interactions with physicians simply because they're sitting at a desk not trying to drive around and find people and/or get in through the office. Corey FishmanCEO at Iterum Therapeutics00:36:08Those 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. We believe that those virtual reps can be a very important part of our organization in addition to the in-field reps. I do not want to minimize one or the other because they're both incredibly important. 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're talking about. Ed ArceSenior Research Analyst at West Park Capital00:36:54Okay. At this point, are you considering other marketing channels like medical journals or engagement via social media or other channels like that? Corey FishmanCEO at Iterum Therapeutics00:37:12Yeah. I think what we've talked a lot about with our partners at EVERSANA is things like social media tend to be more effective nowadays than the traditional kind of journal ads and things like that. 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. 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. 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. Altogether, then it makes everything more efficient. Corey FishmanCEO at Iterum Therapeutics00:38:02It's just a question of having that flexibility. Ed ArceSenior Research Analyst at West Park Capital00:38:07Sounds good. Thanks again and congrats and best of luck as you continue this launch. Corey FishmanCEO at Iterum Therapeutics00:38:15Thanks. Thanks for the questions. Moderator00:38:18Thank you. This concludes our Q&A session. I'll hand back over to Corey Fishman for closing remarks. Corey FishmanCEO at Iterum Therapeutics00:38:25Thank you, Becky. In closing, we believe we've made some very solid progress in the first 10 weeks of Orlynvah commercialization. Physicians see a place in the market for Orlynvah, and many physicians have begun prescribing for multiple patients. We will continue to work tirelessly toward growing the Orlynvah patient base and driving incremental revenues. We really appreciate your support as we continue the Orlynvah 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. Moderator00:39:05This concludes today's call. Thank you for joining us. You may now disconnect your lines.Read moreParticipantsExecutivesKevin DaltonSenior Director of Legal AffairsChristine CoyneChief Commercial OfficerJudy MatthewsCFOCorey FishmanCEOAnalystsJason McCarthySenior Managing Director and Head of Biotechnology Research at Maxim GroupModeratorEd ArceSenior Research Analyst at West Park CapitalPowered by