Q4 2024 Iterum Therapeutics PLC Earnings Call

Okay.

Unknown Executive: Hello, everyone, and welcome to the Iterum Therapeutics PLC fourth quarter and full year 2024 financial results.

Speaker Change: Hello, everyone and welcome to the bitter end Therapeutics plc fourth quarter and full year 2024 financial results. My name is and I will be your coordinator today. If you would like to ask a question. Please press star followed by one on your telephone keypad, if you change your mind.

Unknown Executive: My name is Ezra and I will be your coordinator today. If you would like to ask a question, please press star followed by one on your telephone keypad. If you change your mind, please press star followed by two.

Speaker Change: Please press star followed by two I will now hand, you over to you.

Louise Barrett: I will now hand you over to Louise Barrett, Senior Vice President Legal Affairs to begin. Louise, please go ahead.

Speaker Change: Louise Barrett Senior Vice President legal affairs to begin do we use. Please go ahead.

Louise Barrett: Thank you, Idra. Good morning and welcome to Iterum Therapeutics fourth quarter and full year 2024 financial results and business update conference call. A press release with our fourth quarter and full year results was issued earlier this morning and can be found on our website.

Speaker Change: Thank you Indra.

Speaker Change: Good morning, and welcome to interim Therapeutics fourth quarter and full year 'twenty 'twenty four financial results and business update conference call.

Speaker Change: Its release with our fourth quarter full year with their 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, Chief Financial Officer, Judy mapping.

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, Judith will provide details on our financial results and then we'll open the lines to Q&A.

Speaker Change: Cory will provide some opening remarks, Judy will provide details on our financial results and then we'll open the lines to 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 our LINVAT, the sufficiency of our cash resources to fund operating expenses into the second half of 2025, our strategic process to sell, license or otherwise dispose of our rights to our LINVAT, our ability to complete pre-commercialization activities for our LINVAT, our ability to develop a commercial launch plan either directly or with a commercial partner if we are unsuccessful at entering into or completing a strategic transaction.

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.

Speaker Change: The development of therapeutic and market potential of our Linda the sufficiency of our cash resources to fund operating expenses into the second half of 2025.

Speaker Change: Our strategic process to sell a license or otherwise dispose of our rights to arlinda.

Speaker Change: Our ability to complete pre commercialization activities for Linda our ability to develop a commercial launch plan either directly or with a commercial partner. If we are successful in entering into are completing a strategic transaction.

Louise Barrett: and the expected issuance of patents and the term and coverage provided by such patents on issue. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including but not limited to risks and uncertainties concerning the outcome, impact, effects and results of our evaluation of strategic alternatives, including the terms, timing, structure, value, benefits and costs of any strategic alternative, our ability to complete a strategic alternative transaction, our ability to raise sufficient capital and successfully prepare and implement commercialization plans for an investment with a commercial partner or directly if we were unsuccessful in entering into or completing a strategic transaction, The market opportunity for and the potential market acceptance of our LINVAS, our ability to continue with the going concern, the accuracy of our expectations regarding how far into the future our cash and hand will fund our ongoing operations and other factors discussed under the captioned risk factors in the annual report filed with the SEC this morning and other documents filed with the SEC from time to time.

Speaker Change: And the expected issuance of patents in the term and coverage provided by such patents at issue actual results may differ materially from those indicated by these forward looking statements as a result of various factors outside of our control.

Speaker Change: But not limited to risks and uncertainties concerning me I come impact effects and results of our evaluation of strategic alternatives, including the terms timing structure value benefits and costs of any strategic alternatives.

Speaker Change: Our ability to complete a strategic alternative transaction, our ability to raise sufficient capital and successfully prepare and implement commercialization paths burdened with a commercial partner are directly if we're unsuccessful in entering into completing a strategic transaction.

Speaker Change: The market opportunity for it and the potential market acceptance of our <unk>, our ability to continue as a going concern the accuracy of our expectations regarding how far into the future our cash in hand Thunder ongoing operation.

Speaker Change: Other factors discussed under the caption caption risk factors in the annual report filed with the SEC. This morning, and other documents filed with the SEC from time to time.

Louise Barrett: In addition, any shocking 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 stocking 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.

Speaker Change: Pacifically disclaim any obligation to update such statements.

Louise Barrett: We will also be referencing non-GAAP financial measures during this call. We've provided reconciliations of GAAP-reported 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've provided a reconciliation of GAAP reported to non-GAAP adjusted information in the press release issued this morning.

Corey Fishman: Now, with that all said, I'll turn it over to you, Corey, for your opening remarks. Thanks, Louise. Welcome, and thanks for joining us today. I'd like to provide a brief recap of 2024 and talk a bit about key activities and milestones in 2025. Overall, 2024 was a very good year for Iterum. In January, we generated positive results in our Pivotal Phase 3 Reassure clinical trial comparing oral sulopenem to Augmentin in adult women with uncomplicated urinary tract infections. very efficiently pulled together our NDA resubmission, which was submitted in April. In September, we had a successful advisory committee meeting, and in October of 2024, received FDA approval for Orlinva, the brand name for our oral sulopenum bilayer product.

Speaker Change: No. It was not all that I'll turn it over to Corey for your opening remarks.

Corey Fishman: Thanks Louise.

Corey Fishman: Welcome and thanks for joining us today.

Corey Fishman: To provide a brief recap of 2024 and talk a bit about key activities and milestones in 2025.

Corey Fishman: Overall 2024 was a very good year for interim.

Corey Fishman: In January we generated positive results in our pivotal phase III reassure clinical trial, comparing oral pseudo program to augmenting and adult women with uncomplicated urinary tract infections.

Corey Fishman: Pretty efficient we pulled together, our NDA resubmission, which was submitted in April.

Corey Fishman: In September we had a successful advisory Committee meeting in October of 2024 received FDA approval for Lindbergh the brand name for our oral <unk> product.

Corey Fishman: Orlymba is indicated for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms E. coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

Corey Fishman: Or Linda is indicated for the treatment of uncomplicated urinary tract infections caused by the designated micro organisms E coli.

Corey Fishman: Yellow pneumonia or Proteus rebels, and adult women, who have limited or no alternative oral anti bacterial treatment options.

Corey Fishman: Orlinva is the first and only approved oral pennant in the United Now I'll share a few comments with you as to why we are so excited about the potential for a limba in the market. The uncomplicated urinary tract infection market in the U.S. is quite large and generates an estimated 40 million prescriptions annually. Orlymba is the first and only oral penum approved in the United States and the second FDA approved treatment for uncomplicated urinary tract infections in the past two decades. Orlinda will potentially be the first branded product to enter the uncomplicated urinary tract infection market in over 25 years.

Corey Fishman: Linda is the first and only approved oral program in the United States.

Corey Fishman: Now I'll share a few comments with you as to why we are so excited about the potential for <unk> in the market.

Corey Fishman: The uncomplicated urinary tract infection market U S is quite large and generate an estimated 40 million prescriptions annually.

Corey Fishman: Remember is the first and only oral Panama approved in the United States and the second FDA approved treatment for uncomplicated urinary tract infections in the past two decades.

Corey Fishman: Linda will potentially be the first branded product and through the uncomplicated urinary tract infection market in over 25 years.

Corey Fishman: The leading product in the uncomplicated urinary tract infection market, nitrofurantoin, was approved in 1953. And the majority of the other oral products in the market were approved in the 1970s and 1980s. The extensive use of these products over time has led to rising resistance rates, resulting in the most widely used products having resistance rates approaching 20%. And those rates can run as high as 30%. As most prescribing for uncomplicated urinary tract infections occurs in period. Increasing resistance rates creates a challenge for practicing physicians since the efficacy of these products are continuing to be eroded over time.

Corey Fishman: The leading product EMEA uncomplicated urinary tract infection market Nitro pure <unk> was approved in 1953 and the majority of the other oral products market were approved in the 19 seventies and 19 eighties.

Corey Fishman: The extensive use of these products over time.

Corey Fishman: Led to rising resistance rates, resulting in the most widely used products, having resistance rates approaching 20%.

Corey Fishman: Those rates can run as high as 30%.

Corey Fishman: As most prescribing for uncomplicated urinary tract infections occurs in Paraguay.

Corey Fishman: Creasing resistance rates creates a challenge for practicing physicians since the efficacy of these products are continuing to be eroded over time.

Corey Fishman: Additionally, almost all of the widely used oral products in this therapy area have some safety concerns that again create challenges for treating physicians as to their choice of agent to use.

Corey Fishman: Additionally, almost all of the widely used oral products in this therapy area have some safety concerns that again create challenges for treating physicians as to their choice of agent to use.

Corey Fishman: Unfortunately, with almost no innovation in decades, physicians have been forced to use agents that may not work as well as they would like for their patients. With the Orlinva approval, there now could be an alternative treatment option for those patients who have limited or no other oral treatment options available. We believe that there are many patients that fall into this category, specifically elevated risk patients. We define elevated-risk patients as women that fall into any of the following categories. Women who are 65 years or older, women who have diabetes, women with a history of recurrent or drug resistant infections, or women that have other comorbidities that negatively impact their immune system.

Corey Fishman: Unfortunately, with almost no innovation in decades physicians have been forced to use agents that may not work as well as they would like for their patients.

With fewer Lindbergh approval, there now could be an alternative treatment option for those patients who have limited or no other oral treatment options available.

Corey Fishman: We believe that there are many patients that fall into this category specifically elevated expectations.

Corey Fishman: We defined elevated risk patients as women that fall into any of the following categories.

Corey Fishman: Women, who are 65 years or older.

Corey Fishman: Women, who have diabetes women with a history of recurrent or drug resistant infections or women that have other comorbidities that negatively impact their immune systems.

Corey Fishman: This group of patients are most at risk, given their profiles, and many physicians are challenged to treat these patients with existing oral options that have substantial resistance, as well as safety hurt. Another key group of patients in this therapy area that are in significant need of a new efficacious and safe oral treatment alternative are the patients that have pathogens resistant to all commonly used oral antibiotics. in our Reassure uncomplicated urinary tract infection clinical trial. pleaded last year and conducted exclusively in the U.S. Across almost 1,000 patients, we found that approximately 1% of these patients had an isolate that was resistant to all available oral antibiotics.

Corey Fishman: This group of patients are most at risk given their profiles and many physicians are challenged to treat these patients with existing oral options that have substantial resistance as well as safety hurdles.

Corey Fishman: Another key group of patients in this therapy area better in significant need of a new efficacious and safe oral treatment alternative are the patients that have pathogen resistance to all commonly used oral antibiotics.

Corey Fishman: In our reassure uncomplicated urinary tract infection clinical trial. Please.

Corey Fishman: We did last year and conducted exclusively in the U S.

Corey Fishman: Across almost 1000 patients we found that approximately 1% of these patients.

Corey Fishman: Isolate that was resistant to all available oral antibiotics.

Corey Fishman: or Limba could play an important role in treating these patients as well. As we look at protection for Orlinva with the formal confirmation from the FDA of five additional years of marketing exclusivity under the GAIN Act, Orlinva has market exclusivity for a total of 10 years from the date of approval, or until October 25, 2034. Additionally, our U.S. patent portfolio provides protection for OLINVA into 2039, with issued U.S. patents covering both method of use and composition of matter. I've submitted patent information for four U.S. patents for Olinva that are listed in FDA's Orange Book Approved Drug Products with Therapeutic Equivalence Evaluation.

Speaker Change: Or Linda can play an important role in treating these patients as well.

Speaker Change: As we look at protection for all member with the formal confirmation from the FDA of five additional years of marketing exclusivity under the gain act or Linda has market exclusivity for a total of 10 years from the date of approval or until October 20.

Speaker Change: 2034.

Speaker Change: Additionally, our U S patent portfolio provides protection for <unk> into 'twenty 39 issued U S patents covering both method of use and composition of matter.

Speaker Change: We have submitted information for four U S patents for Lindbergh that are listed in Fda's Orange book approved drug products with therapeutic equivalents evaluations.

Corey Fishman: Overall, we're very pleased with the amount of protection that our limbic should have in the U.S. market to capture value without competition from a potential generic product. In addition to the in-license and issued patents we have, There are a number of pending patent applications in the U.S. and other jurisdictions, including Europe and China.

Speaker Change: Overall, we're very pleased with the amount of protection that our members should have in the U S market to capture value without competition from a potential generic product.

Speaker Change: In addition to the invoicing and issued patents we have.

Speaker Change: There are a number of pending patent applications in the U S and other jurisdictions, including Europe and China.

Corey Fishman: As we enter 2025, there are a few items to note. Our key priority remains the previously announced strategic process to sell, license, or otherwise dispose of our rights to Orlinva with the goal of maximizing value for our state. Along with our financial advisor, we have conducted outreach to dozens of companies since our approval and have and will continue to engage with those that are potentially interested in a strategic transaction. As neither Iterum nor our financial advisor appointed to assist the board in evaluating various strategic alternatives, it's in control of whether our efforts on the strategic front will result in any definitive offer to consummate such a transaction, or if we do receive a definitive offer, whether the terms are as favorable as anticipated or acceptable to the board.

Speaker Change: As we enter 2025, there are a few items to note.

Speaker Change: Our key priority remains the previously announced strategic process to sell license or otherwise dispose of our rates to Orlando with the goal of maximizing value for our stakeholders.

Speaker Change: Along with our financial advisor.

Speaker Change: We have conducted outreach to dozens of companies since our approval and have and will continue to engage with those that are potentially interested in a strategic transaction.

Speaker Change: As neither interim nor our financial adviser appointed to assist the board in evaluating various strategic alternatives is in control of whether our efforts on the strategic front will result in any definitive offered to consummate such a transaction.

Speaker Change: Sure.

Speaker Change: Do receive a definitive offer whether the terms are as favorable as anticipated or acceptable to the board.

Corey Fishman: In parallel to the strategic process, we have begun to evaluate other options for maximizing the value of Orlinva, which may include seeking to raise capital to support the commercialization of Orlinva. We plan to engage in pre commercial activities in order to develop the foundation for a highly targeted launch of Oralynva with a commercial partner or directly subject to raising sufficient capital to ensure that the product is made available to patients and physicians as soon as possible. On the financial side, we have repaid the principal and interest due under our exchangeable notes at the end of January in accordance with their terms. Additionally, based on our current operating plan, including currently planned pre-commercialization activities, we expect our cash will be sufficient to fund operations into the second half of 2025.

Speaker Change: In parallel to the strategic process, we have begun to evaluate other options for maximizing the value of horror Lindbergh, which may include seeking to raise capital to support the commercialization of our Lindbergh.

Speaker Change: We plan to engage in pre commercial activities in order to develop the foundation for a highly targeted launch of Orlando with a commercial partner or directly subject to raising sufficient capital to ensure that the product is made available to patients and physicians as soon as Pos.

Speaker Change: <unk>.

Speaker Change: On the financial side, we have repaid the principal and interest due under our exchangeable notes at the end of January in accordance with their terms.

Speaker Change: Additionally, based on our current operating plan, including currently planned pre commercialization activities. We expect our cash will be sufficient to fund operations into the second half of 2025.

Judith Matthews: Now I'll turn the call over to Judy Matthews, our CFO for financial Thanks Corey. Total operating expenses were $3.7 million in the fourth quarter and $18.7 million for the full year 2024 compared to $11.4 million and $47.5 million in the fourth quarter and full year 2023. 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 $1.3 million for the fourth quarter and $10.5 million for the full year 2024 compared to $9.7 million and $40 million for the same periods in 2023.

Speaker Change: Now I'll turn the call over to Judy Matthews, our CFO for a financial update.

Judy Matthews: Thanks Corey.

Judy Matthews: Total operating expenses were $3 $7 million in the fourth quarter and $18 7 million for the full year of 2024 compared to $11 4 million $47 5 million in the fourth quarter and full year 2023.

Judy Matthews: Our operating expenses include cost of sales, which is primarily the amortization of an intangible asset research and development expenses and general and administrative expenses.

Judy Matthews: R&D costs were $1 3 million for the fourth quarter, and 10 5 million for the full year 2024, compared to nine 7 million and $40 million for the same periods in 2023.

Judith Matthews: The primary driver of the decrease in R&D expense for the fourth quarter and full year was the completion of the REASSURE trial. GNA costs were $2.1 million for the fourth quarter and $8 million for the full year 2024, compared to GNA costs of $1.7 million and $7.5 million for the same period in 2023. The primary driver of the increase in GNA expense for the fourth quarter and full year was higher legal fees.

Judy Matthews: Primary driver of the decrease in R&D expense for the fourth quarter and full year was the completion of the reassure trial.

Judy Matthews: G&A costs were $2 1 million for the fourth quarter and <unk> 8 million for the full year 2024, compared to G&A costs of one 7 million and $7 5 million at the same period in 2023.

Speaker Change: Mary driver of the increase in G&A expense for the fourth quarter and full year with higher legal fees.

Judith Matthews: Our net loss on a U.S. GAAP basis was $6.6 million for the fourth quarter of 2024 and $24.8 million for the full year. On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $3.1 million and $17.6 million for the fourth quarter and full year 2024 compared to our non-GAAP net loss of $10.7 million and $43.8 million for the fourth quarter and full year 2023. The $7.6 million and $26.2 million decrease in our non-GAAP net loss for the fourth quarter and full year was primarily a result of lower R&D expenses related to our reoccur trial.

Speaker Change: Our net loss on a U S. GAAP basis was $6 $6 million for the fourth quarter of 2024, and four $824 8 million for the full year.

Speaker Change: On a non-GAAP basis, which excludes certain non cash adjustments.

Speaker Change: Net loss of $3 $1 million and $17 6 million for the fourth quarter and full year 2024, compared to our non-GAAP net loss of 10 7 million and 43 eight.

Speaker Change: <unk> 8 million for the fourth quarter and full year 2023.

Speaker Change: The $7 6 million and $26 2 million decrease in our non-GAAP net loss for the fourth quarter and full year was primarily a result of lower R&D expenses related to our trial.

Judith Matthews: At the end of December, we had cash and cash equivalents of $24.1 million. Based on our current operating plan, which includes our currently planned pre-commercialization spend, we expect that our cash and cash equivalents, including $4.8 million of net proceeds raised under our ATM from January 1st through February 6, 2025, will be sufficient to fund our operations into the second half of 2025. Pursuant to our exclusive license with Pfizer for Sulopenem, we were obligated to make a regulatory milestone payment of $20 million to Pfizer upon approval of oral Sulopenem. In accordance with the license, we elected to defer payment for 2 years and delivered a promissory note to Pfizer in the amount of $20 million in October 2024.

Speaker Change: At the end of December we had cash and cash equivalents of $24 $1 million.

Speaker Change: On our current operating plan, which includes our currently planned pre commercialization.

Speaker Change: We expect that our cash and cash equivalents, including $4 8 million of net proceeds raised under our ATM from January one through February.

Speaker Change: The 25 will be sufficient to fund our operations into the second half of 2025.

Speaker Change: Pursuant to our exclusive license with Pfizer first of all we were obligated to make a regulatory milestone payment of $20 million to fight their upon approval of oral solo com and.

Speaker Change: In accordance with the lifetime, we elected to defer payments for two years and delivered a promissory note to fiber in the amount of $20 million in October 2020 for.

Judith Matthews: This note accrues interest at an annual rate 8% on a daily compounded basis until paid in full.

Speaker Change: This note accrues interest at an annual rate eight daily compounded basis until Covid in the fall.

Judith Matthews: On January 31, 2025, we repaid the outstanding principal and interest due under the exchangeable notes in accordance with their terms. As of February 6, 2025, we had approximately 34.6 million ordinary shares outstanding.

Speaker Change: On January 31, 2025, we repaid the outstanding principal and interest due under the exchangeable notes in accordance with their terms.

Speaker Change: As of February six 2025, we had approximately 34 6 million ordinary shares outstanding.

Unknown Executive: We will now open it up for questions. Thank you very much. If you would like to ask a question, please press star followed by one on your telephone keypad.

Speaker Change: We will now open it up for questions.

Speaker Change: Thank you very much if you would like to ask a question. Please press star followed by one on your telephone keypad now.

Unknown Executive: Now, please ensure your device is unmuted locally. If you change your mind or your question has already been answered, please press star followed by two.

Speaker Change: Please ensure your devices and you said locally if you change your mind or your question has already been unfair each piece press star two.

Unknown Executive: Our first question comes from Ed Arca with HC Ringrath. Ed, your line is now open. Please go ahead.

Speaker Change: Our first question comes from RK.

Speaker Change: <unk> <unk> with H C Green grass edge. Your line is now open. Please go ahead.

Thomas Yip: Hello, good morning, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you so much for the kind of questions.

Speaker Change: Hello. Good morning, everyone. This is Thomas Yip asking a couple of questions for decades, so much but there are no questions.

Corey Fishman: Perhaps first question, I wonder if you can discuss any feedback or details on your ongoing discussions with potential partners and also if you can discuss what type of entities are you having discussions with, such as pharma companies or financial organizations? You know, what type of partners are you seeking out?

Speaker Change: First question.

Speaker Change: Wonder if because discuss any feedback with details on the ongoing discussions with potential partners and also with you can.

Speaker Change: Discuss what type of entities.

Speaker Change: Have you had any discussions with such as pharma companies or financial organizations.

Speaker Change: What types of oil.

Speaker Change: Partners are you actually going out correctly.

Corey Fishman: Thanks for the question, Thomas. As you'd imagine, we really can't talk in detail about any any ongoing conversations. What I will say is, as I mentioned, is we have had outreach to dozens of companies, which include both pharma companies as well as financial investors. And that process is ongoing.

Thomas Yip: Thanks for the question Thomas.

Thomas Yip: As you would imagine we really can't talk in detail about any any ongoing conversations what I will say as I mentioned is we have had outreached to dozens of companies, which include both pharma companies as well as financial investors and that process is ongoing.

Unknown Executive: Understood.

Corey Fishman: And then on the other side, you mentioned that their commercial preparations are ongoing. I wonder if you can highlight some activities on that front. Yep, so we are currently engaging in some research. with payers with physician, we're also doing some analytics around targeting around geographies, all in the in the stead of putting the foundation in place.

Thomas Yip: Understood.

Thomas Yip: And then on the other side.

Speaker Change: You mentioned that there were commercial preparations are ongoing wonder if you can highlight some activities on that front.

Speaker Change: Yes, so we.

Speaker Change: We are currently engaging in some research.

Speaker Change: With payers with physicians, we're also doing some analytics around targeting around geographies all in the.

Speaker Change: In the stead of putting the foundation in place should we end up in a place where the strategic transaction does not occur.

Corey Fishman: Should we end up in a place where the strategic transaction does not occur or the strategic transaction doesn't generate something that is sufficient in the board's eyes for commercial launch either by us or with a commercial partner here at Iterum.

Or the strategic transaction doesn't generate something that is sufficient in the border ties.

Speaker Change: For commercial launch either by us or with a commercial partner.

Speaker Change: Here at Arrow.

Speaker Change: Okay.

Unknown Executive: Understood.

Unknown Executive: That's all the questions we have for now. Thank you so much for taking the questions and looking forward to progress in ongoing discussions. Thanks, Tom.

Speaker Change: Understood.

Speaker Change: Alright, Thats all questions now. Thank you so much left to go to questions.

Speaker Change: Looking forward progress.

Speaker Change: The ongoing discussions.

Speaker Change: Thanks Thomas.

Unknown Executive: Thank you very much. Just as a reminder, if you would like to ask a question, please press star followed by one on your telephone keypad now.

Speaker Change: Thank you very much just as a reminder, if you would like to ask a question. Please press star followed by one on your telephone keypad now.

Unknown Executive: We currently have no more questions.

Speaker Change: We currently have no more questions.

Corey Fishman: I will hand back over to Corey Fishman for any closing remarks.

Speaker Change: I'll hand back over to Corey Fishman for any closing remarks.

Corey Fishman: Thank you. We appreciate you joining us today.

Speaker Change: Thank you.

Speaker Change: We appreciate you joining us today.

Corey Fishman: 2024 was a pivotal year for Iterum as we received our FDA approval for Linva, the first and only oral pendant approved in the US. We believe the uncomplicated urinary tract infection market is underserved and that there is a substantial unmet need for effective treatment options. We look forward to Orlinva entering the U.S. market and ensuring that Orlinva is made available to patients and physicians in order to provide this important treatment option to treat uncomplicated urinary tract infection.

Speaker Change: 2024 was a pivotal year for interim as we received our FDA approval for Lindbergh, the first and only oral Panama approved in the U S. We.

Speaker Change: We believe the uncomplicated urinary tract infection market is underserved and that there is a substantial unmet need for effective treatment options.

Speaker Change: We look forward to Orlando entering the U S market and ensuring that our Linda is made available to patients and physicians in order to provide this important treatment option to treat uncomplicated urinary tract infections.

Corey Fishman: Thanks again and have a good day.

Speaker Change: Thanks, again and have a good day.

Unknown Executive: Thank you very much, Corey, and thank you all. Our speakers on today's call.

Speaker Change: Thank you very much Cory and thank you all.

Speaker Change: Our speakers on today's call. This concludes today's conference call you may now disconnect your lines.

Unknown Executive: This concludes today's conference call.

Unknown Executive: You may now disconnect your lines.

Speaker Change: Yeah.

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Speaker Change: Okay.

Speaker Change: Sure.

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