Iterum Therapeutics Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 13, 2025

There are 5 speakers on the call.

Operator

Hello, everyone, and thank you for joining the Ichorum Therapeutics plc First Quarter twenty twenty five Earnings and Business Update Call. My name is Lucy, and I'll be coordinating your call today. I will now hand over to your host, Louise Barrett, SVP of Legal Affairs to begin. Please go ahead.

Speaker 1

Thank you, Lucy. Good morning, and welcome to Interim Therapeutics plc's first quarter twenty twenty five earnings and business update call. A press release with our first quarter results was issued earlier this morning and can be found on our website. We are joined this morning by our Chief Executive Officer, Corie Fishman and our Chief Financial Officer, Judy Matthews. Corie will provide some opening remarks, Judy will provide details on our financial results and then we'll open the lines for Q and A.

Speaker 1

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 Orlynda with sufficiently our cash resources to fund our operating expenses into 2026 our strategic process to sell, license or otherwise dispose of our rights to zolipanem our ability to complete pre commercialization activities for Orlynda and prepare for a potential launch of Orlynda by the fourth quarter of twenty twenty five 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 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 our ability to complete a strategic alternative transaction our ability to successfully prepare and implement commercialization plans for Orlynda with a commercial partner or directly the design and timing of potential launch plans the market opportunity for and potential market acceptance of our Lindbergh our ability to continue with the going concern the accuracy of our expectations regarding how far into the future our cash on 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 SEC this morning.

Speaker 1

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. 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 all said, now I'll turn it over to you, Corey, for your opening remarks.

Speaker 2

Thanks, Louise. 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 as acceptable being in the best interest of our stakeholders. Business development remains a potential opportunity for us at any point.

Speaker 2

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 Orlynda 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 OLYMZA over the last several months.

Speaker 2

As we have noted before, The U. S. Market has been plagued by a lack of innovation in this therapy area over the last twenty five 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 Orlynda for the treatment of uncomplicated urinary tract infections in adult women with designated microorganisms, we believe there is an excellent opportunity in this expensive market, which has been hugely neglected for nearly three decades.

Speaker 2

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 40,000,000 prescriptions annually in The U. S. And of those approximately two thirds or about 26,000,000 prescriptions are written for at risk patients.

Speaker 2

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 Orlynda's 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 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 oral antibiotic pricing, resulting net sales would be over $250,000,000 in that year.

Speaker 3

With regard to new competition in

Speaker 2

the marketplace, there was a product approved in April of twenty twenty four 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 Orlynda to market as quickly and efficiently as possible. I want to spend a minute and talk about the potential commercialization of Orlynda. We have been working with Eversana, an end to end commercialization firm, to prepare for a potential launch.

Speaker 2

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 Orlyva, 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 Orlymba 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 three key criteria. Number one, the rate of antibiotic resistance in that territory.

Speaker 2

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, 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 three criteria to determine optimal geographies or to remain in the existing territories but 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 Orlynda in The U.

Speaker 2

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.

Speaker 2

Lastly, we have extended our cash runway into 2026, which includes the potential launch of Orlynda by the fourth quarter. In summary, as we look forward, we are very excited about the potential commercialization of Orlynda in The U. S. The market dynamics remain favorable. Our planning work is going very well.

Speaker 2

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 02/1939. I'll now turn the call over to Judy Matthews, our Chief Financial Officer, for a financial update.

Speaker 4

Thanks, Corey. Total operating expenses were $3,700,000 in the first quarter of twenty twenty five compared to the $6,200,000 in the first quarter of twenty twenty four. 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 and D costs were approximately $600,000 in the first quarter compared to $4,000,000 for the same period in 2024. The primary driver of the decrease in R and D expense for the first quarter was the decrease in costs associated with the ReAssure trial.

Speaker 4

G and A costs were $2,800,000 for the first quarter compared to G and A costs of $2,200,000 for the same period in 2024. The primary driver of the increase in G and A expense for the first quarter was pre commercialization activities. Our net loss on a U. S. GAAP basis was $4,900,000 for the first quarter of twenty twenty five compared to a net loss of $7,100,000 for the first quarter of twenty twenty four.

Speaker 4

On a non GAAP basis, which excludes certain noncash adjustments, our net loss of $3,300,000 in the first quarter of twenty twenty five compared to our non GAAP net loss of $5,800,000 in the first quarter of twenty twenty four. The $2,500,000 decrease in our non GAAP net loss for the first quarter was primarily a result of lower R and D expenses related to our ReAssure trial. At the March, we had cash and cash equivalents of $12,700,000 Based on our current operating plan, which includes our currently planned pre commercialization spend and potential commercial launch of Orlynda by the fourth quarter of twenty twenty five, we expect that our cash and cash equivalents together with $1,000,000 of net proceeds raised under our aftermarket offering program from April 1 through 04/22/2025 and that proceeds of $4,200,000 from the registered direct offering that closed 04/30/2025 will be sufficient to fund our operations into 2026. On 01/31/2025, we repaid the outstanding principal and interest due under the exchangeable notes in accordance with their terms. As of 05/12/2025, we had approximately 40,000,000 ordinary shares outstanding.

Speaker 4

Now we will open the line for questions.

Operator

Thank

Speaker 2

you.

Operator

We have a question from Matthew Keller of H. C. Wainwright. Just

Speaker 2

two quick ones from us. The first, I was wondering if

Speaker 3

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? Matt, this is Corey. Thanks for the questions. Can you

Speaker 2

just repeat the second one? I'm sorry.

Speaker 3

Oh, yes, no problem. Just if you foresee you mentioned the pre commercialization activities. If there's any other outstanding rate limiting steps that you might foresee ahead of Arlinda's launch later this year.

Speaker 2

Got you. Okay. Thanks.

Speaker 3

Does that make So

Speaker 2

let's just tackle them in the order you asked them. There's really not a lot of color we can add on any commercial partner discussions. I'm assuming that meant 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 Correct.

Speaker 2

We've had a number of big discussions. I think there's 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, that 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.

Speaker 2

We'd be happy to have those conversations with 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 six months. The market continues to be attractive, And we really think that Borlynda 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.

Speaker 2

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 quarter? 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 impediments, are 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.

Speaker 2

So it's not like we have 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.

Speaker 3

Yes. No, it totally makes sense. Thanks for taking my questions. And again, congrats on the quarter. Thanks again.

Speaker 2

Thanks Matt.

Operator

We have no further questions, so I will hand back to Corey Fishman, CEO, for closing remarks.

Speaker 2

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 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.

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Key Takeaways

  • Management has yet to secure an acceptable partnership or strategic transaction for Orlynda or zolipenem but continues outreach while preparing for a potential stand-alone U.S. launch.
  • The uncomplicated urinary tract infection market in the U.S. generates ~40 million prescriptions annually, with ~26 million for “at-risk” patients who have limited or no oral options and represent Orlynda’s addressable market.
  • In collaboration with Eversana, Ichorum has invested in pre-commercial activities—market research, payer engagement, promotional messaging and distribution strategy—with a goal to launch Orlynda by Q4 2025.
  • First-quarter operating expenses fell to $3.7 million from $6.2 million year-over-year, driven by reduced R&D spend (from $4 million to $0.6 million), while G&A rose to $2.8 million due to pre-commercial costs.
  • As of March 31, cash and equivalents were $12.7 million, supplemented by ~$5.2 million raised in subsequent offerings, extending the runway into 2026 and enabling the potential Orlynda launch.
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