Q1 2025 Iterum Therapeutics PLC Earnings Call and Business Update
Hello, everyone and thank you for joining the assurance Therapeutics plc first quarter 'twenty 25 earnings and business update call. My name is Lucy and I will be coordinating your call today. During the presentation. You can register your question by pressing stoffel, let by one on your telephone keypad, if you change.
Unknown Executive: Hello everyone, and thank you for joining the Iterum Therapeutics PLC first quarter 2025 earnings and business update call. My name is Lucy and I'll be coordinating your call today. During the presentation, you can register a question by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two on your telephone keypad.
Your mind, please buy stuff on it by two and your telephone keypad I will now hand over to your host Luis Barrett SVP of legal affairs to begin. Please go ahead.
Louise Barrett: I will now hand over to your host Louise Barrett, SVP of Legal Affairs to begin. Please go ahead. Thank you, Lucy.
Luis Barrett: Thank you Lucy.
Louise Barrett: Good morning and welcome to Iterum Therapeutics PLC first quarter 2025 learning and business update call. A press release of the first quarter results was issued earlier this morning and can be found on our website.
Good morning, and welcome to <unk> Therapeutics plc first quarter 2025 earnings and business update call.
Luis Barrett: The press release first quarter results was issued earlier this morning and can be found on our website.
Louise Barrett: We are joined this morning by our Chief Executive Officer Corey Fishman and our Chief Financial Officer Judith Matthews. Corey will provide some opening remarks, Judy will provide details on our financial results and then we'll open the lines for Q&A.
Speaker Change: I'm joined this morning by our Chief Executive Officer, Corey Benchmark, and our Chief Financial Officer, Judy Mackey.
Speaker Change: We will provide some opening remarks, Judy will provide details on our financial results and then we will open the lines for Q&A.
Louise Barrett: Before we begin, I'd 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 the development, therapeutic and market potential of Orlinda, the sufficiency of our cash resources to fund our operating expenses into 2026. Our strategic process to sell, license or otherwise dispose of our rights to Zulipanem. Our ability to complete pre-commercialization activities for Arlinva and prepare for a potential launch of Arlinva by the fourth quarter of 2025, and the protection provided by our PAC. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our control, including risks and uncertainties concerning the outcome, impact, effects, and results of our evaluation of strategic alternatives, including the terms, timing, structure, value, benefits, and cost of any strategic alternative, our ability to complete a strategic alternative transaction, our ability to successfully prepare and implement commercialization plans for our LIMBA with a commercial partner or directly, the design and timing of potential launch plans, the market opportunity for and potential market acceptance of our LIMBA, our ability to continue as a going concern, the accuracy of our expectations regarding how far into the future our cash in hand will fund our ongoing operations, and other factors discussed under the caption risk factors in our quarterly report on Form 10-Q filed with the FCC this morning.
Speaker Change: Before we begin I'd 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 the development of therapeutic potential of our Orlando the sufficiency of our cash resources to fund our operating expenses into 2026.
Speaker Change: Our strategic process to sell license or other way, where I can see the panel.
Speaker Change: Our ability to complete pre commercialization activities for <unk> and prepare for a potential launch burden at fourth quarter of 2025 of the protection provided by our patents.
Speaker Change: Actual results may differ materially from those indicated by these forward looking statements as a result of various factors outside our control, including risks and uncertainties concerning the outcome impact effects and results of our evaluation of strategic alternatives, including the terms timing structure value benefits and cost of any strategic alternatives are.
Speaker Change: Ability to complete the striking a strategic alternative transaction our ability to successfully prepare an estimated commercialization plans burdened with the commercial partner are directly the design and timing of a potential launch, but the market opportunity for and potential market acceptance of our <unk> our ability to continue the going concern the acura.
Speaker Change: See if our expectations regarding how far into the future our cash on hand will fund our ongoing operations.
Speaker Change: Factors discussed under the caption risk factors in our corner of course on Form 10-Q filed with the SEC. This morning.
Louise Barrett: In addition, any forward-looking statements represent only our views 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.
Speaker Change: In addition, any forward looking statements represent our views as of the date of this call and should not be relied well as representing our views as of any subsequent date, we specifically disclaim any obligation to update such statements.
Louise Barrett: We will also be referencing non-GAAP financial measures during the call. We've provided reconciliations of GAAP reporters to non-GAAP-adjusted information in the press release issued this morning.
Speaker Change: We will also be referencing non-GAAP financial measures during the call. We provided reconciliations of GAAP reported non-GAAP adjusted information in the press release issued this morning.
Corey Fishman: With that all said, now I'll turn it over to you, Corey, for your opening remarks. Thanks, Louie. Welcome and thanks for joining us today.
Corey Benchmark: That all said now I'll turn it over to Corey for your opening remarks.
Corey Benchmark: Thanks Louise.
Speaker Change: Welcome and thanks for joining us today.
Corey Fishman: I'd like to begin by providing some comments on our company priorities and associated activities. Our outreach to potential business development partners has yet to result in a transaction that the board views as acceptable, being in the best interests of our stakeholders. Business development remains a potential opportunity for us at any point, and while we continue to pursue a strategic transaction, we remain open and excited to engage in discussions as they arise.
Speaker Change: Like to begin by providing some comments on our company priorities and associated activities.
Speaker Change: Our outreach to potential business development partners has yet to result in a transaction that the board reviews, it acceptable, bringing in the best interests of our stakeholders.
Speaker Change: Mr. Belmont remains a potential opportunity for us at any point and while we continue to pursue a strategic transaction, we remain open and excited to engage in discussions.
Speaker Change: Yes.
Corey Fishman: Having said that, we believe there is urgency to bring Orlinda to the US market to serve patients suffering with uncomplicated urinary tract infections, who have limited or no other oral alternative treatment options. And as such, we have been preparing for the potential commercialization of Orlinda over the last several months. As we have noted before, the U.S. market has been plagued by a lack of innovation in this therapy area over the last 25 years, and antibiotic resistance to existing generic oral treatment options is eroding the efficacy of current therapies. Additionally, almost all of the existing oral treatments have some safety challenges that again leaves physicians looking for efficacious and safe alternative treatment.
Speaker Change: Having said that we believe there is urgency to bring or lingered through the U S market.
Speaker Change: Patients suffering with uncomplicated urinary tract infections.
Speaker Change: Limited or no.
Speaker Change: Oral alternative treatment options and <unk>.
Speaker Change: As such we have been preparing for the potential commercialization of aluminum, but over the last several months.
Speaker Change: And we have every have noted before the U S market has been plagued by a lack of innovation in this therapy area over the last 25 years and antibiotic resistance to existing generic oral treatment options.
Speaker Change: Roading efficacy of current therapies.
Speaker Change: Additionally, almost all of the existing oral treatments have some safety challenges that again relieves physicians looking for efficacious and safe alternative treatments.
Corey Fishman: Given this background, and with the safety and efficacy of Orlinva for the treatment of uncomplicated urinary tract infections in adult women with designated microorganisms, we believe there's an excellent opportunity in this extensive market which has been hugely neglected for nearly three decades.
Speaker Change: Given this background and with the safety and efficacy of Orlando for the treatment of uncomplicated urinary tract infections and adult women with perfect micro organisms. We believe there is an excellent opportunity in this extensive market, which has been hugely neglected for nearly three decades.
Speaker Change: Let's take a moment now and talk about the uncomplicated urinary tract infection market in the U S.
Corey Fishman: take a moment now and talk about the uncomplicated urinary tract infection market in the U.S. It is quite large, and based on our research, generates approximately 40 million prescriptions annually in the U.S., and of those, approximately two-thirds, or about 26 million prescriptions, are written for at-risk patients. At-risk patients are defined as women who are elderly, have comorbidities like diabetes, heart failure, kidney failure, or cancer, or women with a history of recurrent infection. We believe these at-risk patients represent a limited addressable market, as they likely are the patients with limited or no other oral treatment options available, and are the patients most in need of new therapy.
Speaker Change: It is quite large and based on our research generates approximately 40 million prescriptions annually in the U S and <unk>.
Speaker Change: Approximately two thirds or about 26 million prescriptions are written for at risk patients.
Speaker Change: At risk patients are defined as women who are elderly.
Speaker Change: Comorbidities like diabetes heart failure, kidney failure or cancer.
Speaker Change: Or women with a history of recurrent infections.
Speaker Change: We believe these at risk patients represent or limited addressable market has been locally urban patients with limited or no. Other oral treatment options available and are the patients most in need of new therapies.
Corey Fishman: to put this addressable market size in a practical perspective. If a company were to capture a 1% share of the addressable market at peak, say the fifth or sixth year after launch, and using current branded oil antibiotic pricing. Resulting net sales would be over $250 million in that year.
Speaker Change: To put this addressable market size and a practical perspective.
Speaker Change: If the company were to capture a 1% share of the addressable market.
Speaker Change: Pete.
Speaker Change: The fifth or sixth year after launch.
Speaker Change: And using current branded oral antibiotic pricing.
Speaker Change: Resulting net sales would be over $250 million in that year.
Speaker Change: With regard to new competition in the marketplace. There was a product improved in April of 2024 that have yet to launch.
Corey Fishman: With regard to new competition in the marketplace, there was a product approved in April of 2024 that has yet to launch. Additionally, in the first quarter of this year, GlaxoSmithKline received approval for a product in the uncomplicated urinary tract infection space, and their current guidance is that they will launch in the second half of this year. Clearly, this increases the urgency for us to get Orlinda to market as quickly and efficiently as possible.
Speaker Change: Additionally, during the first quarter of this year Glaxosmithkline received approval for new products.
Speaker Change: In uncomplicated urinary tract infection space and their current guidance is that they will launch in the second half of this year.
Speaker Change: Clearly this increases the urgency for us to get remember to market as quickly and efficiently as possible.
Speaker Change: I want to spend a minute and talk about the potential commercialization of <unk>.
Corey Fishman: I want to spend a minute and talk about the potential commercialization of Orleans.
Corey Fishman: We have been working with Eversoma, an end-to-end commercialization firm, to prepare for a potential launch. As we build out our commercial launch plan, we have invested in pre-commercialization activities, including market research with physicians and payers. Building the Key Promotional Messaging for Erlenbe. Determining the optimal trade, distribution and patient services strategies. Developing Discussion Materials for Payers. Beginning to compile a medical information database. and Determining Potential Territory Alignment for Sales Resource. We believe that all of the work done so far indicates Oralimba as an important alternative for patients with limited or no other oral treatment options. In a commercialization scenario, we would expect to execute our launch in safety.
Speaker Change: We've been working with ever summer.
Speaker Change: And commercialization firm to prepare for a potential launch.
As we build out our commercial launch plan.
Speaker Change: We have invested in pre commercialization activities, including market research with physicians and payers.
Speaker Change: Building the key promotional messaging for <unk>.
Speaker Change: Determining the optimal trade distribution and patient services strategies.
Speaker Change: Developing discretion materials for repairs.
Speaker Change: Beginning to compile and medical information database.
Speaker Change: And determining potential territory alignment for sales resources.
Speaker Change: We believe that all of the work done so far indicates or member as an important alternative for patients with limited or no other oral treatment options.
Speaker Change: Any commercialization scenario, we would expect to execute our launch in fitness.
Corey Fishman: Our first phase would be to put commercial resources in a limited number of territories based on three key criteria. Number one, the rate of antibiotic resistance in that territory. Number two, the number of physicians in a territory who read a large amount of prescriptions in the uncomplicated urinary tract infection field. and number three, Manage Care Access in a Designated Territory.
Speaker Change: Our first phase would be to put commercial resources limited number of territories based on three key criteria.
Speaker Change: Number one the rate of antibiotic resistance in that territory.
Speaker Change: Number two the number of physicians in a territory who've made a large amount of prescriptions in the uncomplicated urinary tract infection field.
Speaker Change: And number three managed care access and a designated territory.
Speaker Change: Post launch assuming we see solid results from these initial territories. We expect the next phase of the plan would be to either expand the number of territories. We are promoting in still using the same III criteria to determine optimal geographies.
Corey Fishman: Post-launch, assuming we see solid results in these initial territories, we expect the next phase of the plan would be to either expand the number of territories we are promoting in, still using the same three criteria to determine optimal geography, or to remain in the existing territories or cover more positions in those territories with additional resources. Of course, any near-term expansion would be subject to successfully raising additional capital. We expect that in a commercialization scenario, we will be able to launch Orlinda in the U.S. market by the fourth quarter.
Speaker Change: To remain in the existing territories recover more physicians in those territories with additional resources.
Speaker Change: Of course, any near term expansion would be subject to successfully raising additional capital.
Speaker Change: We expect that in a commercialization scenario, we will be able to launch <unk> in the U S market by the fourth quarter.
Speaker Change: There were a couple of other topics to cover today as well.
Corey Fishman: There are a couple other topics I'd like to cover today as well. As some of you may know, in January of this year, we repaid the outstanding principal and interest due under our exchangeable note. This repayment eliminated a large amount of debt that has been on the company's books for a number of years. Lastly, we have extended our cash runway into 2026, which includes the potential launch of Orlinva by the fourth quarter. In summary, as we look forward, we are very excited about the potential commercialization of Orlando in the U.S. The market dynamics remain favorable.
Speaker Change: As some of you may know in January of this year, we repaid the outstanding principal and interest due under our exchangeable notes.
Speaker Change: This repayment eliminated a large amount of debt that has been on the companys books for a number of years.
Speaker Change: Lastly, we have extended our cash runway into 2026, which includes the potential launch of our loan book by the fourth quarter.
Speaker Change: In summary, as we look forward, we are very excited about the potential commercialization of <unk> in the U S.
Speaker Change: Market dynamics remained favorable our planning work is going very well.
Corey Fishman: Our planning work is going very well. No new products have launched in the space to date. And we have a very long runway to capture value with our patent protection going into 2039.
Speaker Change: No new products have launched in this space to date.
Speaker Change: And we have a very long runway to capture value with our patent protection going into 2013.
Speaker Change: I'll now turn the call over to Judy Matthews, our Chief financial officer for incremental update.
Judith Matthews: I'll now turn the call over to Judy Matthews, our Chief Financial Officer for a financial update. Thanks, Corey. Total operating expenses were $3.7 million in the first quarter of 2025, compared to the $6.2 million in the first quarter of 2024. Operating expenses include cost of sales, which is primarily the amortization of an intangible asset, research and development expenses, and general and administrative expenses. R&D costs were approximately $600,000 in the first quarter compared to $4 million for the same period in 2024. The primary driver of the decrease in R&D expense for the first quarter was the decrease in costs associated with the Reassure Trust.
Judy Matthews: Thanks Corey.
Judy Matthews: Total operating expenses were $3 500.
Judy Matthews: $10 million in the first quarter of 2025.
Judy Matthews: The $6 2 million in the first quarter of 2024.
Judy Matthews: Operating expenses, including cost of sales, which is primarily the amortization of an intangible asset.
Judy Matthews: Research and development expenses and general and administrative expenses.
Judy Matthews: R&D costs were approximately $600000 in the first quarter compared to $4 million for the same period in 2020 for.
Judy Matthews: The primary driver of the decrease in R&D expense for the first quarter with the decrease in costs associated with the reassert trial.
Judith Matthews: The GNA costs were $2.8 million for the first quarter, compared to GNA costs of $2.2 million for the same period in 2021. The primary driver of the increase in GME expense for the first quarter was pre-commercialization. Our net loss on a U.S. gap basis was $4.9 million for the first quarter of 2025 compared to a net loss of $7.1 million for the first quarter of 2024. on a non-GAAP basis, which excludes certain non-cash adjustments. Our net loss of $3.3 million in the first quarter of 2025 compared to our non-GAAP net loss of $5.8 million in the first quarter of 2024.
Judy Matthews: G&A costs were $2 $8 million for the first quarter compared to G&A costs of $2 $2 million for the same period in 2024.
Judy Matthews: Primary driver of the increased <unk> expense for the first quarter with pre commercialization activities.
Judy Matthews: Our net loss on a U S GAAP basis with $4 $9 million for the first quarter of 2025 compared to a net loss.
Judy Matthews: $1 million for the first quarter 'twenty four.
Judy Matthews: On a non-GAAP basis, which excludes certain non cash adjustments.
Judy Matthews: Our net loss of $3 $3 million in the first quarter of 2025 compared to our non-GAAP net loss of $5 $8 million in the first quarter of 2024.
Judith Matthews: The $2.5 million decrease in our non-GAAP net loss for the first quarter was primarily a result of lower R&D expenses related to our reissue. At the end of March, we had cash and cash equivalents of $12.7 million. Based on our current operating plan, which includes our currently planned pre-commercialization spend and potential commercial launch of Orlando by the 4th quarter of 2025. We expect that our cash and cash equivalents, together with 1Million dollars of net proceeds raised under our at the market offering program from April 1st to April 22nd, 2025. And that proceeds of 4.2Million dollars from the registered direct offering that closed April 30th, 2025.
Judy Matthews: The $2 5 million decrease in our non-GAAP net loss for the first quarter was primarily a result of lower R&D expenses related to reassure trial.
Judy Matthews: At the end of March we had cash and cash equivalents of 12 $7 million.
Judy Matthews: Based on our current operating plan, which includes our currently planned create commercialization.
Judy Matthews: And potential commercial launch of Orlando by the fourth quarter of 2025.
Judy Matthews: Expect that our cash and cash equivalents together with $1 million of not proceeds raised under our aftermarket offering program from April.
Judy Matthews: Ultimately back in 2025 and that proceeds of $4 2 million from the registered direct offering that closed April 30 of 2025 will be sufficient to fund our operations into 2026.
Judith Matthews: Will be sufficient to fund our operations into 2026. On January 31, 2025, we repay the outstanding principal and interest due under the exchangeable notes in accordance with their terms. As of May 12 2025, we had approximately 40 million ordinary shares out.
Judy Matthews: Yeah.
Judy Matthews: On January 31, 2025, we repaid the outstanding principal and interest due under the exchangeable notes in accordance with their terms.
Judy Matthews: As of May 12, 2025, we had approximately 40 million ordinary shares outstanding.
Unknown Executive: Now we will open the line for questions. Thank you. To ask a question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally.
Judy Matthews: Now we will open the line for questions.
Judy Matthews: Thank you to ask a question. Please press star followed by one on your telephone keypad now.
Judy Matthews: If you change your mind, Please press star followed by chip.
Judy Matthews: When preparing to ask a question. Please ensure your device is unmeasured locally.
Speaker Change: We have a question from Matthew <unk> of H C. Wainwright Matthew Your line is now open. Please go ahead.
Unknown Executive: We have a question from Matthew Keller of HC Wainwright.
Matthew Keller: Matthew, your line is now open, please go ahead. Yeah, thank you. Good morning, everyone. And thanks for taking our questions. Just two quick ones from us.
Speaker Change: Yes. Thank you good morning, everyone and thanks for taking my questions. Just two quick ones from US first I was wondering if you could possibly speak a little bit more to the maturity.
Corey Fishman: The first, I was wondering if you could possibly speak a little bit more to the maturity of these conversations you're having with potential commercial partners? And then secondly, do you foresee any, if any, really outstanding rate limiting steps ahead of launch later this year?
Speaker Change: These conversations youre, having with potential commercial partners and then secondly, do you foresee any if any really outstanding rate limiting steps ahead of launch later this year.
Speaker Change: Yeah.
Speaker Change: Matt This is Corey and thanks for the questions can you just repeat the second one im sorry.
Corey Fishman: Matt, this is Corey. Thanks for the questions. Can you just repeat the second one? I'm sorry. Oh yeah, no problem. Just if you foresee, you know, you mentioned the pre-commercialization activities, if there's any other outstanding rate-limiting steps that you might foresee ahead of Orlando's launch later this year? Gotcha. Okay, thanks. Let's just tackle them in the way you asked them, you know, there's, there's really not a lot of color we can add on any commercial partner discussions. I'm assuming that meant sort of the BB side of it. You know, we, we do view Eversana as our commercial partner, but I'm assuming that's not really what you were asking.
Matt: Oh, Yeah, no problem. If you foresee you mentioned the pre commercial or pre commercialization activities. If there's any other.
Matt: Outstanding rate limiting steps that you might foresee.
Matt: Head of our limited launch later this year.
Matt: Gotcha, Okay. Thanks.
Matt: So look.
Matt: Let's tackle them in the order you asked them, there's really not a lot of color we can add on any commercial partner discussions.
Matt: Im assuming that sort of a BB side of it.
Matt: We do view ever Sona as our commercial partner, but I'm, assuming that's not really what you're asking.
Corey Fishman: I think, you know, we've had, we've had a number of big discussions. I think there's a, you know, a host of rationales in people's minds as to why right now may not be the right time from their perspective to do any kind of partnership with us. But it's important to note, as I said, you know, that business development is a constant in the biotech world and certainly for us as well. There's, there's never a, you know, a long time for that conversation. So we absolutely remain open to it. We, you know, we'd be happy to have those conversations with the specific parties if and when they arise.
Matt: I think correct.
Matt: We've had a number of good discussions I think there is a host of rationale in People's mind as to why right now may not be the right time from their perspective to do any kind of partnership with us.
Matt: But it's important to note as I said.
Matt: Business development is a constant in the biotech world and certainly for us as well there is never a.
Matt: A long time for that conversation. So we absolutely remain open to you.
Matt: We'd be happy to have those conversations with the specific parties.
Matt: And when they arise and we will certainly do that.
Speaker Change: <unk> said that we really do feel there is an urgency here we've been approved for six months.
Speaker Change: The market continues to be attractive and we really think that but or Linda can play a very important role in treating these at risk patients and so we really want to get this product into the hands of patients and physicians and that's really our goal.
Corey Fishman: And that leads into your second question, which are there, are there any rate-limiting steps kind of remaining in order to be launching the drug by the fourth quarter? And I'm happy to, you know, to tell you that I don't see any big hurdles. There's a ton of work to do. But with regard to real impediments, there are no, you know, no hurdles out there that would stop us from staying on that timeline. The good news is we've made product and we have product available. So it's not like we have manufacturing, you know, timelines to deal with right now.
And that leads into your second second question with your other are there any rate limiting steps remaining in order to be launching the drug by the fourth quarter.
Speaker Change: I'm happy to tell you that I don't see any big hurdles theres a ton of work to do but with regard to real impediment there are no.
Speaker Change: No hurdles out there that would stop us from staying on that timeline and the good news is we will.
Speaker Change: Sorry, commercial we've made product and we have product available. So it's not like we are manufacturing timelines to deal with right now and so I think we're in pretty good shape to actually hit that timeline of getting commercial by the fourth quarter.
Matthew Keller: And so I think we're in pretty good shape to actually hit that timeline of getting commercial by the fourth quarter. Yep, no, totally makes sense. Thanks for taking my questions. And again, congrats on the quarter. Thanks again.
Speaker Change: Yes, no it totally makes sense. Thanks for taking my questions and again congrats on the quarter. Thanks again.
Speaker Change: Thanks, Matt.
Speaker Change: We have no further questions. So I'll hand back to Corey Fishman CEO for closing remarks.
Corey Fishman: We have no further questions, so I will hand back to Corey Fishman, CEO, for closing remarks. Thanks, Lucy. We appreciate you joining us today. We're very excited about the potential launch of Orlinva by the fourth quarter of this year. We believe there really is a significant need for Orlinva in the uncomplicated urinary tract infection market for those at risk patients. And we are looking forward to making this first and only approved oral penna product available to patients and physicians as efficiently and quickly as we can.
Corey Fishman: Thanks Lucy.
Speaker Change: We appreciate you joining us today, we're very excited about the potential launch of our Lindbergh by the fourth quarter of this year. We believe there really is a significant need for online, but in the uncomplicated urinary tract infection market for those at risk patients and we are looking forward to making this first and only <unk>.
Speaker Change: Oral panel product available to patients and physicians as efficiently and quickly as we can.
Unknown Executive: So thanks again, and have a great day, everyone. This concludes today's call. Thank you for joining. You may now disconnect your line.
Speaker Change: So thanks, again and have a great day everyone.
Speaker Change: This concludes today's call. Thank you for joining you may now disconnect your lines.
Speaker Change: Yeah.
Speaker Change: [music].