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19-05-2025
- Business
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Iterum Therapeutics Announces Extension of Term of Promissory Note
DUBLIN and CHICAGO, May 19, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the 'Company' or 'Iterum'), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported that Pfizer Inc. ('Pfizer') has agreed to extend the term for payment of the regulatory milestone payment of $20.0 million until October 25, 2029. 'We are very pleased to announce that Pfizer has agreed to extend the due date for payment of the regulatory milestone associated with ORLYNVAH™'s approval by the FDA,' said Corey Fishman, Iterum's Chief Executive Officer. 'The $20.0 million promissory note was due October 2026 and is now due October 2029. As a result, any capital raised or earned in the near term from the sales of ORLYNVAH™ can be strategically invested to enable a successful launch of ORLYNVAH™, including through the expansion into new territories or concentration of resources in high prescribing geographies.' Pursuant to the license agreement entered into on November 18, 2015, by and among the Company, Iterum Therapeutics International Limited ('ITIL') and Pfizer (the 'Pfizer License Agreement'), ITIL agreed to make a regulatory milestone payment of $20.0 million to Pfizer (the 'Milestone Payment') upon the approval of oral sulopenem for commercial sale in the United States by the U.S. Food and Drug Administration ('FDA'). The Company had the option to deliver notice of its election to defer such payment for up to two years from the date of approval and have a promissory note issued by ITIL in the amount of the Milestone Payment to Pfizer. After receiving FDA approval for ORLYNVAH™ on October, 25, 2024, the Company notified Pfizer on October 28, 2024, that it was electing to defer payment of the Milestone Payment for two years, or until October 25, 2026 (the 'Deferral Period'), and a promissory note was issued to Pfizer by ITIL. On May 13, 2025, the Company and ITIL entered into an amended and restated promissory note (the 'A&R Note') and a letter agreement relating to the A&R Note and amending the Pfizer License Agreement. The A&R Note extends the Deferral Period by an additional three years, or until October 25, 2029. In connection with the extension, ITIL agreed in the A&R Note to increase the annual rate of interest from eight percent (8%) to ten percent (10%) on a daily compounded basis, beginning on October 26, 2026. ITIL also agreed that it would not, directly or indirectly, (1) create, incur, assume, guaranty or otherwise become liable for any indebtedness that is senior in right of payment to the A&R Note, except for indebtedness incurred with the consent or waiver of Pfizer, or (2) create, grant or incur any lien on any of its property or assets, subject to specified exceptions (including liens securing permitted indebtedness and liens incurred with the consent or waiver of Pfizer). ITIL also agreed to pay Pfizer a transaction fee and to pay Pfizer's legal expenses. About Iterum Therapeutics plc Iterum is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received approval of its NDA for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the FDA and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit About ORLYNVAH™ ORLYNVAH™ is a novel oral penem antibiotic for the treatment of uUTIs. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins. Cautionary Note Regarding Forward-looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding Iterum's plans, strategies and prospects for its business, including the development, therapeutic and market potential of ORLYNVAH™, Iterum's ability to complete pre-commercialization activities for ORLYNVAH™ and Iterum's ability to prepare and implement commercialization plans for ORLYNVAH™, including Iterum's ability to expand into new territories and put additional resources in high prescribing geographies. In some cases, forward-looking statements can be identified by words such as 'may,' 'believes,' 'intends,' 'seeks,' 'anticipates,' 'plans,' 'estimates,' 'expects,' 'should,' 'assumes,' 'continues,' 'could,' 'would,' 'will,' 'future,' 'potential' or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Iterum's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside Iterum's control, including risks and uncertainties concerning the outcome, impact, effects and results of Iterum's evaluation of strategic alternatives, including the terms, timing, structure, value, benefits and costs of any strategic alternatives, Iterum's ability to complete a strategic alternative transaction, Iterum's ability to raise sufficient capital and successfully prepare and implement commercialization plans for ORLYNVAH™ with a commercial partner or directly, including Iterum's ability to build and maintain a sales force and prepare for a potential commercial launch of ORLYNVAH™, the ability of shareholders and other stakeholders to realize any value or recovery as part of a wind down process if Iterum is unsuccessful at entering into or completing a strategic transaction or preparing and implementing commercialization plans for ORLYNVAH™, the market opportunity for and the potential market acceptance of ORLYNVAH™ for uUTIs caused by certain designated microorganisms in adult women who have limited or no alternative oral antibacterial treatment options, Iterum's ability to continue as a going concern, uncertainties inherent in the conduct of clinical and non-clinical development, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, changes in public policy or legislation, commercialization plans and timelines, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of Iterum's expectations regarding how far into the future Iterum's cash on hand will fund Iterum's ongoing operations, Iterum's ability to maintain its listing on the Nasdaq Capital Market and other factors discussed under the caption 'Risk Factors' in its Quarterly Report on Form 10-Q filed with the SEC on May 13, 2025, and other documents filed with the Securities and Exchange Commission from time to time. Forward-looking statements represent Iterum's beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Investor Contact:Judy MatthewsChief Financial Officer 312-778-6073IR@
Yahoo
14-05-2025
- Business
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Iterum Therapeutics PLC (ITRM) Q1 2025 Earnings Call Highlights: Strategic Moves and Financial ...
Total Operating Expenses: $3.7 million in Q1 2025, down from $6.2 million in Q1 2024. R&D Costs: $600,000 in Q1 2025, compared to $4 million in Q1 2024. G&A Costs: $2.8 million in Q1 2025, up from $2.2 million in Q1 2024. Net Loss (GAAP): $4.9 million in Q1 2025, compared to $7.1 million in Q1 2024. Net Loss (Non-GAAP): $3.3 million in Q1 2025, compared to $5.8 million in Q1 2024. Cash and Cash Equivalents: $12.7 million at the end of March 2025. Outstanding Shares: Approximately 40 million as of May 12, 2025. Warning! GuruFocus has detected 2 Warning Signs with ITRM. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Iterum Therapeutics PLC (NASDAQ:ITRM) is preparing for the potential commercialization of ORLYNVAH, targeting a large U.S. market with approximately 40 million prescriptions annually for uncomplicated urinary tract infections. The company has extended its cash runway into 2026, providing financial stability for upcoming operations and potential product launch. Iterum Therapeutics PLC (NASDAQ:ITRM) has significantly reduced its operating expenses, with a decrease from $6.2 million in Q1 2024 to $3.7 million in Q1 2025. The company has repaid the outstanding principal and interest on its exchangeable notes, eliminating a large amount of debt. Iterum Therapeutics PLC (NASDAQ:ITRM) has partnered with Everson, an end-to-end commercialization firm, to prepare for the potential launch of ORLYNVAH, indicating a strategic approach to market entry. Iterum Therapeutics PLC (NASDAQ:ITRM) has not yet secured a business development transaction that the Board finds acceptable, indicating challenges in finding suitable partners. The company faces competition from new products approved in the uncomplicated urinary tract infection space, increasing urgency for ORLYNVAH's market entry. Iterum Therapeutics PLC (NASDAQ:ITRM) reported a net loss of $4.9 million for Q1 2025, although reduced from the previous year, it still indicates financial challenges. The increase in general and administrative expenses due to pre-commercialization activities suggests higher operational costs. The company's ability to expand its commercialization efforts is contingent on successfully raising additional capital, indicating potential financial constraints. Q: Can you speak more about the maturity of conversations with potential commercial partners and any outstanding rate-limiting steps ahead of ORLYNVAH's launch? A: Corey Fishman, CEO, stated that while there are ongoing discussions with potential partners, there is no significant update to provide. EVERSANA is considered their commercial partner for now. The urgency to launch ORLYNVAH remains high, and there are no major hurdles anticipated that would delay the planned launch by the fourth quarter. Manufacturing timelines are not a concern as product is already available. Q: Are there any significant impediments to launching ORLYNVAH by the fourth quarter? A: Corey Fishman, CEO, confirmed that there are no significant impediments to launching ORLYNVAH by the fourth quarter. The company has made substantial progress, including having product available, which positions them well to meet the timeline. Q: What is the current financial position of Iterum Therapeutics, and how does it support the planned launch? A: Judith Matthews, CFO, reported that Iterum has cash and cash equivalents of $12.7 million as of the end of March. With additional proceeds from recent offerings, the company expects to fund operations into 2026, supporting the planned launch of ORLYNVAH. Q: How does Iterum view the market opportunity for ORLYNVAH? A: Corey Fishman, CEO, highlighted that the U.S. market for uncomplicated urinary tract infections is large, with approximately 40 million prescriptions annually. ORLYNVAH targets at-risk patients, representing a significant addressable market. Capturing even a 1% market share could result in over $250 million in net sales at peak. Q: What are the strategic priorities for Iterum Therapeutics moving forward? A: Corey Fishman, CEO, emphasized the urgency of bringing ORLYNVAH to market to address the unmet needs of patients with uncomplicated urinary tract infections. The company is focused on commercialization efforts and remains open to strategic partnerships that align with their goals. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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14-05-2025
- Business
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Q1 2025 Iterum Therapeutics PLC Earnings Call
Louise Barrett; Senior Vice President, Legal Affairs; Iterum Therapeutics PLC Corey Fishman; President, Chief Executive Officer, Director; Iterum Therapeutics PLC Judith Matthews; Chief Financial Officer; Iterum Therapeutics PLC Matthew Keller; Analyst; H.C. Wainwright & Co., LLC Operator 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 will be coordinating your call today. (Operator Instructions) I will now hand over to your host, Louise Barrett, SVP of Legal Affairs, to begin. Please go ahead. Louise Barrett Thank you, Lucy. Good morning, and welcome to Iterum Therapeutics plc first-quarter 2025 earnings and business update call. Our press release for our first quarter results was issued earlier this morning can be filed on our website. We are joined this morning by our Chief Executive Officer, Corey Fishman; and our Chief Financial Officer, Judy 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. 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 and market potential of -- is sufficiently our cash resources to further operating expenses into 2026. Our strategic process to sell license or otherwise dispose it to see panel, our ability to complete precommercialization activities for ORLYNVAH and prepare for a potential launch of ORLYNVAH by the fourth quarter of 2025 and the protection provided by our patents. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our control, including risks and uncertainties concerning the outcome, impact effects and results of our evaluation of strategic alternatives, including the terms, timing, structure -- benefits and costs of any strategic alternatives; our ability to complete a strategic alternative transaction, our ability to successfully prepare and intimate commercialization plans for our ORLYNVAH with the commercial partner or directly. The design and time and well potential launch plans. The market opportunity for and potential market acceptance of ORLYNVAH our ability to continue the going concern, the accuracy of our expectations regarding how far in the future our cash on hand will fund our ongoing operations and other factors discussed under the caption risk factors in our report on Form 10-Q filed with the SEC this morning. In addition, any forward-looking statements represent a review as of the date of the role, which should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We've provided reconciliations of GAAP reported to non-GAAP adjusted information in the press release issued this morning. With that, I'll say -- now I'll turn it over to you, Corey, for your opening remarks. Corey Fishman Thanks, Louis. Welcome, and thanks for joining us today. 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 is acceptable being in the best interest 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. . Having said that, we believe there is urgency to bring ORLYNVAH to the U.S. 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 ORLYNVAH over the last several months. As we have noted before, -- the U.S. market has been played 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 treatments. Given this background and with the safety and efficacy of ORLYNVAH for the treatment of uncomplicated urinary tract infections, in adult women with designated microorganisms, we believe there is an excellent opportunity in this extensive market, which has been hugely neglected for nearly 3 decades. Let's 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 2/3 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 infections. We believe these at-risk patients represent ORLYNVAH 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 therapies. To put this addressable market size in a practical perspective, if the 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 oral antibiotic pricing, resulting net sales would be over $250 million in that year. 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 ORLYNVAH to market as quickly and efficiently as possible. I want to spend a minute and talk about the potential commercialization of ORLYNVAH. We have been working with Everson 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 ORLYNVAH 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 resources. We believe that all the work done so far indicates ORLYNVAH 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 phases. Our first phase would be to put commercial resources in a limited number of territories based on 3 key criteria: number one, the rate of antibiotic resistance in that territory. Number two, the number of physicians in a territory who wrote a large amount of prescriptions in the uncomplicated urinary tract infection field. And number three, the managed care access in a designated territory. 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 3 criteria to determine optimal geographies or to remain in the existing territories or cover more physicians 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 ORLYNVAH in the U.S. market by the fourth quarter. There are a couple of 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 notes. 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 ORLYNVAH by the fourth quarter. In summary, as we look forward, we are very excited about the potential commercialization of ORLYNVAH in the U.S. The market dynamics remain favorable. Our planning work is going very well. No new products have launched in this space to date, and we have a very long runway to capture value with our patent protection going into 2039. I'll now turn the call over to Judy Matthews, our Chief Financial Officer, for a financial update. Judith Matthews Thanks, Corey. Total operating expenses were $3.7 million in the first quarter of 2025 compared to $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 trial. 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. The primary driver of the increase in G&A expense for the first quarter was pre-commercialization activities. . Our net loss on a U.S. GAAP 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 noncash 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. 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 ReAssure trial. 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 ORLYNVAH by the fourth quarter of 2025, we expect that our cash and cash equivalents, together with $1 million of net proceeds raised under our aftermarket offering program from April 1 through April 22, 2025 and net proceeds of $4.2 million from the registered direct offering that closed April 30, 2025, we will be sufficient to fund our operations into 2026. On January 31, 2025, we repaid 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 outstanding. Now we will open the line for questions. Operator (Operator Instructions) Matthew Keller, H.C. Wainwright. Matthew Keller Just 2 quick ones from us. 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. Corey Fishman Matt, this is Corey. Thanks for the question. Can you just repeat the second one? I'm sorry. Matthew Keller No problem. Just if you foresee -- you mentioned the pre-commercialization activities. Is there any other outstanding rate-limiting steps that you might foresee ahead of ORLYNVAH's launch later this year? Does that make sense? Corey Fishman Let's tackle them in the -- there's really not a lot of color we can add on any commercial partner discussions I'm assuming that sort of the BD side of it, we do view EVERSANA as our commercial partner, but I'm assuming that's not really what you were asking. I think we've had a number of big discussions. I think there's a host of rationales in people's mind that's too wide 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, the business development is a constant in the biotech world and certainly for us as well. There's never a long time for that conversation. So we absolutely remain open to it. We'd be happy to have those conversations with the specific parties if and when they arise and we will certainly do that. Having said that, we really do feel there's an urgency here. We've been approved for 6 months. The market continues to be attractive, and we really think that ORLYNVAH 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. And that leads into your second question, which are there any rate-limiting steps kind of remaining in order to be launching the drug by the fourth. And I'm happy to tell you that I don't see any big hurdles. There's a ton of work to do. But with regard to real impediment, there are no hurdles out there that would stop us from staying on that time line. The good news is we've come -- sorry we've made product and we have product available. So it's not like we have manufacturing time lines to deal with right now. And so I think we're in pretty good shape to actually hit that time line of getting commercial by the fourth quarter. Matthew Keller Yes. No, it totally makes sense. And again, congrats on the quarter. Operator We have no further questions, so I will hand back to Corey Fishman's, CEO, for closing remarks. Corey Fishman Thanks, Lucy. We appreciate you joining us today. We're very excited about the potential launch of ORLYNVAH by the fourth quarter of this year. we believe there really is a significant need for ORLYNVAH 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 penem product available to patients and physicians as efficiently and quickly as we can. So thanks again, and have a great day, everyone. Operator This concludes today's call. Thank you for joining. You may now disconnect your lines. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
