Iterum Therapeutics (NASDAQ:ITRM) has announced during its third quarter 2024 earnings call the FDA approval of ORLYNVAH, an innovative oral treatment for uncomplicated urinary tract infections (UTIs) in adult women. This approval introduces the first oral drug in the penem class to the U.S. market, addressing the need for new treatments due to rising antimicrobial resistance.
The company reported a decrease in operating expenses and a net loss while maintaining sufficient cash resources to fund operations into 2025. Iterum Therapeutics is actively seeking strategic partnerships to enhance stakeholder value following the ORLYNVAH approval.
Key Takeaways
- Iterum Therapeutics received FDA approval for ORLYNVAH, the first oral penem class drug for uncomplicated UTIs in adult women.
- The company benefits from 10 years of market exclusivity under the GAIN Act and patent protection until 2039 in the U.S.
- Operating expenses decreased to $4.9 million in Q3 2024 from $16.7 million in Q3 2023, with a net loss of $6.1 million.
- Iterum Therapeutics expects to have enough cash to fund operations into 2025, including the repayment of exchangeable notes due January 31, 2025.
- The company is exploring strategic alternatives and partnerships post-ORLYNVAH approval.
- The ORLYNVAH label is competitive with no unusual restrictions for patients with complicated UTIs.
- Existing data is sufficient for EU submissions, but additional studies are required for China and Japan approvals.
- Interest in ORLYNVAH as a step-down treatment for complicated UTIs is acknowledged, with confidence in future studies.
- Renewed outreach for strategic partnerships to maximize stakeholder value is underway.
Company Outlook
- Iterum Therapeutics is optimistic about the market potential of ORLYNVAH due to its exclusivity and patent protection.
- The company is confident in the sufficiency of their cash resources for the near future and is actively engaging in strategic partnership discussions.
Bearish Highlights
- The company reported a net loss of $6.1 million in Q3 2024.
- Additional clinical trials are required for regulatory approval in Mainland China and Japan, which may delay market entry in those regions.
Bullish Highlights
- ORLYNVAH enjoys a competitive label and market exclusivity until 2034, with U.S. patent protection until 2039.
- There is significant interest in the drug's potential as a step-down treatment for complicated UTIs, indicating possible future expansion of its use.
Misses
- Despite the positive news, Iterum Therapeutics did not meet the endpoint in trials for complicated UTIs, although this data may still be leveraged for partnerships.
Q&A Highlights
- During the Q&A, the company reiterated its excitement over the FDA approval of ORLYNVAH and the ongoing discussions for partnerships.
- The company clarified that EU regulatory submissions could be made with existing data, simplifying the approval process in Europe.
Iterum Therapeutics' recent FDA approval of ORLYNVAH marks a significant milestone in the treatment of UTIs, offering a new oral therapy option in a landscape of growing antimicrobial resistance. With a clear strategy for patent protection and market exclusivity, the company is well-positioned to explore strategic partnerships and expand its market presence. Despite the challenges ahead, including the need for additional studies in certain markets, Iterum Therapeutics remains focused on maximizing value for its stakeholders and improving patient care with ORLYNVAH.
InvestingPro Insights
Iterum Therapeutics' (ITRM) recent FDA approval of ORLYNVAH has sparked investor interest, as reflected in the company's recent stock performance. According to InvestingPro data, ITRM has shown a strong return of 41.58% over the last month and an impressive 81.01% over the past year. This positive momentum aligns with the company's significant milestone in bringing the first oral penem class drug for uncomplicated UTIs to the U.S. market.
Despite these gains, investors should note that ITRM faces financial challenges. An InvestingPro Tip highlights that the company is "quickly burning through cash," which is consistent with the reported net loss and the company's focus on funding operations into 2025. This cash burn rate is further underscored by the adjusted operating income of -$38.26 million for the last twelve months as of Q2 2024.
Another InvestingPro Tip indicates that ITRM "suffers from weak gross profit margins," which may explain the company's emphasis on seeking strategic partnerships to enhance stakeholder value. This strategy could be crucial for improving the company's financial health and capitalizing on the ORLYNVAH approval.
It's worth noting that InvestingPro offers 12 additional tips for ITRM, providing a more comprehensive analysis for investors interested in delving deeper into the company's prospects. These insights can be particularly valuable given the volatility often associated with biotech stocks following major regulatory decisions.
The market cap of $30.88 million suggests that ITRM is a small-cap company, which typically comes with higher risk and potential for growth. As the company navigates the commercialization of ORLYNVAH and explores strategic alternatives, investors will be watching closely to see if ITRM can translate its regulatory success into financial performance.
Full transcript - Iterum Therapeutics PLC (ITRM) Q3 2024:
Operator: Hello, everyone, and thank you for holding, and welcome to the Iterum Therapeutics Reports Third Quarter 2024 Financial Results. My name is Ezra [ph], and I will be your coordinator today. [Operator Instructions]. I will now hand you over to your host, Louise Barrett, Senior Vice President, Legal Affairs. Louise, please go ahead.
Louise Barrett: Thank you, Ezra. Good morning, and welcome to Iterum Therapeutics' third quarter 2024 financial results and business update conference call. A press release with our third quarter results was issued earlier this morning and can be found on our website. We are joined this morning by our Chief Executive Officer, Corey Fishman; and our Chief Financial Officer, Judy Matthews. Corey will provide some opening remarks, Judy will provide details on our financial results, and then we will 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 today will contain forward-looking statements concerning our plans, strategies and prospects for our business, including the therapeutic and market potential of ORLYNVAH, the sufficiency of our cash resources to fund our operating expenses into 2025, including through the repayment date of the exchangeable notes. The listing of patents for ORLYNVAH in the FDA's Orange Book, the protection provided by our patents for ORLYNVAH and our strategic process to sell license or otherwise dispose of its rights to ORLYNVAH. 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 transaction, our ability to complete the strategic transaction, our ability to successfully prepare and implement commercialization plans for ORLYNVAH with a commercial partner or directly if we are unsuccessful at entering into or completing a strategic transaction, the market opportunity for and the potential market acceptance of ORLYNVAH, the accuracy of expectations regarding how far into the future, our cash on hand will fund our ongoing operations, our ability to maintain our listing on the NASDAQ capital market and other factors discussed under the caption Risk Factors in our quarterly report on Form 10-Q filed with the SEC this morning. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We provide a reconciliations of GAAP reported to non-GAAP adjusted information in the press release issued this morning. With that all said, now I'll turn you over to Corey for your opening remarks.
Corey Fishman: Thank you, Louise. Good morning, and thanks for joining us today. As we previously announced, we are very excited to have received FDA approval for ORLYNVAH, our oral sulopenem product last month 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. Our approval marks the first U.S. approval of an oral product in the penem class of drugs, which is a very potent and safe class of drugs, currently only delivered as intravenous therapy. Having an approved oral penem enables treatment for appropriate patients in the community, where new effective agents are desperately needed. As a potential treatment for patients with uncomplicated urinary tract infections that have limited or no other oral treatment options, ORLYNVAH has the potential to not only effectively treat these patients, but also has the opportunity to help combat the growing health crisis of rising antimicrobial resistance by offering a new treatment alternative. We have received formal communication from the FDA of five additional years of exclusivity under the GAIN Act, meaning that ORLYNVAH has market exclusivity for 10 years from the date of approval or until October 25, 2034. Additionally, our U.S. patent portfolio provides protection for oral sulopenem into 2039, with issued U.S. patents covering both method of use and composition of matter. We have also submitted patent information for four U.S. patents for ORLYNVAH, that will be listed in FDA's Orange Book, approved drug products with therapeutic equivalence evaluations. Overall, we are very pleased that the amount of protection that ORLYNVAH should have in the U.S. market to capture value without competition from a potential generic product. Now I'll provide a few comments on why we are so excited about the potential for ORLYNVAH. The uncomplicated urinary tract infection market in the U.S. has not had a new oral treatment launched in about 25 years. 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 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% or more. As most prescribing for uncomplicated urinary tract infections occurs empirically, this very high and oftentimes increasing resistance rate creates a challenge for practicing physicians, since the efficacy of these products are continuing to be eroded over time. 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. 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 ORLYNVAH 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 at-risk patients. We define at-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. 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. Another key group of patients 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, completed earlier this year and conducted exclusively in the U.S., over almost 1,000 patients, we found that approximately 1% of these patients had an isolate that was resistant to all available oral antibiotics. ORLYNVAH could play an important role in treating these patients as well. We firmly believe that ORLYNVAH has a very important place in the uncomplicated urinary tract infection market for appropriate patients. As we look at our operating plan and go-forward cash runway, we expect to be able to fund our operations into 2025 including through the repayment date of our exchangeable notes due January 31, 2025. And now I'll turn the call over to Judy Matthews for an update on our financial performance.
Judith Matthews: Thanks, Corey. Total (EPA:TTEF) operating expenses were $4.9 million in the third quarter of 2024, compared to $16.7 million in the third quarter of 2023. Operating expenses include research and development expenses and general and administrative expenses. R&D costs were $3.1 million for the third quarter, compared to $14.9 million for the same period in 2023. The primary driver of the $11.8 million decrease in R&D expense for the third quarter was primarily due to higher costs incurred in 2023 to support our REASSURE trial, which began enrollment in October 2022 and completed enrollment in October 2023. G&A costs were $1.8 million for the third quarter of 2024, which is flat to G&A costs of $1.8 million in the third quarter of 2023. Our net loss on a U.S. GAAP basis was $6.1 million for the third quarter of 2024, compared to $3.9 million for the same period in 2023. On a non-GAAP basis, which exclude certain non-cash adjustments, our net loss of $4.8 million in the third quarter of 2024, compared to our non-GAAP net loss of $15.7 million in the third quarter of 2023. The $10.9 million decrease in our non-GAAP net loss for the third quarter was primarily a result of lower R&D expenses related to our REASSURE trial. At the end of September, we had cash, cash equivalents and short-term investments of $14.5 million and including warrant exercises and amounts raised under our ATM subsequent to quarter end, we expect to be able to fund operations into 2025, including through the repayment date of the exchangeable notes on January 31, 2025. As of November 4, 2024, which includes the shares issued under our ATM and warrant exercises, we had approximately 27.5 million ordinary shares outstanding. Also, we currently have approximately $11.1 million of exchangeable notes outstanding, which can be exchanged at the option of the noteholder for approximately 1.9 million shares. If the notes are not exchanged, we are obligated to pay the note holders $11.1 million plus accrued interest in January 2025. Further, upon approval of ORLYNVAH, we owed Pfizer (NYSE:PFE), a $20 million regulatory milestone, which has been deferred for two years for issuance of a promissory note as permitted under the terms of our fiber license. Now we will take questions.
Operator: Thank you very much. [Operator Instructions]. Our first question comes from Ed Arce with HC Wainwright. Ed your line is 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 taking our questions. So first, as you outlined earlier in the call, so with now 10 years of market exclusivity up to 2034. Can you also discuss how far out the sulopenem portfolio provide coverage for both in the U.S. and maybe in Europe as well?
Corey Fishman: Sure, Thomas. Thanks for the question. So the GAIN Act provides the incremental five years of market exclusivity. And so that's 10 years in total from the date of approval. So that goes into 2034. The patents we have, the latest dates of exploration are into 2039 in the U.S., and they would be the same in other territories that when they're granted, assuming they're granted. So we have patents in the U.S. and in a couple of other territories, we do not have them yet granted in Europe. So we have U.S. coverage into 2039 with patents and a couple of other territories, including Japan and Australia, but we have not yet been granted European patents.
Thomas Yip: Understood. And then can you perhaps discuss ORLYNVAH label as it was approved? Does it meet your internal expectations in terms of how broad it is and also the restrictions anticipated?
Corey Fishman: I'm sorry, Thomas, I couldn't hear that.
Thomas Yip: What I was asking was the ORLYNVAH label as it was approved. Just wonder, did they meet your internal expectations in terms of how broad it is? And then also the restrictions anticipated?
Corey Fishman: Yes, sure. It's a good question. Thanks, again. We were very pleased with the label. And I'll tell you exactly what our thoughts were. And I think everyone who has been part of the Iterum story knows that we have always been very consistent in saying this product, we believe, is best suited for folks who are at risk or elevated risk. And having the label that we have, we believe, gives us the opportunity to treat those patients. Unfortunately, in this space, in the complicated urinary tract infection space, our belief is that we're already at a place where most patients have limited oral options available due to resistance, due to safety profiles of the existing drugs and that is really kind of our -- what we thought about and we believe is very appropriate for sulopenem patients. So we're very, very pleased with the label. We don't have any other unusual restrictions. As I think we mentioned last time, we don't have any unusual post marketing requirements, standard pediatric studies as well as surveillance, which are standard for all companies -- and antibiotic companies all have surveillance studies to do. So we're very pleased that we feel like this is a very, very competitive label. And given all the dynamics of the market, we believe it's got an opportunity to do very well.
Thomas Yip: Got it. And then perhaps one last question from us. I wonder if you can discuss what's your impression so far on your discussions on the strategic options to date?
Corey Fishman: Sorry, one more time, Thomas?
Judith Matthews: BD, he's talking about BD.
Corey Fishman: BD? Yes. So we have -- we've renewed our process along with our financial adviser with regard to outreach to companies in an effort to achieve a strategic transaction. And that process, obviously, we're just getting the approval, we just kicked it off in terms of renewing that effort. And we'll be monitoring that as we go forward.
Thomas Yip: Okay. Got it. Thank you again for taking our questions. Looking forward to update on your [Indiscernible] options.
Corey Fishman: Thank you, Thomas.
Operator: Thank you. The next question comes from Jason Mccarthy with Maxim Group. Jason your line is now open. Please go ahead.
Jason Mccarthy: Hi, Corey. Thanks for taking the questions. Just from a partnering or acquirer perspective, given that your -- the last Phase 3, it was only in the U.S., would they need another trial in EU, China, Japan or some other region to extend approvals ex-U.S.? Or is the data sufficient with what you have?
Corey Fishman: Yes. Thanks, Jason, for the question. Appreciate it. It's a good question. Our understanding is that in the EU, if you go down that regulatory pathway, you can file with the current data package. They have a very standard process with check-in points and day 120 questions and day 180 questions, et cetera. So it's kind of a very regulated process, much like it is here. And you do not need another study. My understanding is in China, and Mainland China as well as in Japan, you would need an additional study in the local population. So I think you have opportunity everywhere for that, but it would require a little bit more time in China and Japan. I think the majority of the rest of the world has the ability to use the FDA data, and those are the two bigger countries that I believe are requiring a local clinical trial in for potential approval.
Jason Mccarthy: And thank you. And just one more. For any potential partner or suitor or otherwise, you did have -- I know the trial missed and complicated and surgical. But the data was still very good, kind of vary in a similar vein to the uncomplicated UTI. Do you think that would potentially make this more attractive? Could they leverage that data and do just another study like you did to get approval for uUTI? Is that a part of the discussions that you're having? Or is it just really they're interested potentially uncomplicated only?
Corey Fishman: Yes. I think it's a great question. And I do think there is some interest in complicated UTI as a step-down drug. Again, we obviously didn't hit that endpoint. But to your point, now that you're approved in order to get a formal approved indication, you would need to do only one study. And I believe based on the data that we generated, we have a very good understanding of what that study would look like, who the comparator would be. And I think we would have a very good chance of hitting that end point. And I do think counterparties might be very interested in that because, again, I think that's where the value is in the oral. It's not so much to have another IV because there are lots of IVs out there. But there's very few orals that I think physicians are feeling comfortable not only in the community, but in the hospital to send patients home. So I do think that that could be another area of interest for companies depending on what their portfolios look like.
Jason Mccarthy: Got it. Thanks for taking the question.
Corey Fishman: Thanks Jason.
Operator: Thank you very much, Jason, and everyone for participating in the question-and-answer session that marks the end of our question-and-answer session. I will now hand back over to Corey for any closing remarks.
Corey Fishman: Thanks very much. So we appreciate you all joining us today, and we want to reiterate that we're very excited to have received approval of ORLYNVAH and along with our financial advisers, as I just mentioned, we have renewed our process of outreach to potential partners in an effort to achieve a strategic transaction with the goal of maximizing value for our stakeholders. And that process is underway and ongoing. So we appreciate your interest and your time, and thanks very much, and have a great day.
Operator: Thank you very much, Corey, and thank you, everyone, for joining. That ends today's conference call. You may now disconnect your lines.
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