Good afternoon, everyone, and thank you for attending today's Iterum Therapeutics Business Update call. My name is Jasmine, and I will be your moderator today. All lines will be muted during the presentation portion of the call. I would now like to pass the conference over to your host, Kevin Dalton, Senior Director of Legal Affairs. You may now proceed.
Thank you, Jasmine. Good afternoon, everyone, and thank you for joining this Iterum Therapeutics Conference Call. Joining me today is our Chief Executive Officer, Corey Fishman, and on the call, Corey will discuss our partnership with Eversana for the planned commercial launch of Orlynvah and provide a general business update. A press release announcing this partnership was issued earlier this morning and can be found on our website. Before we begin, I would 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.
These include the following: the development, therapeutic, and market potential of Orlynvah, the opportunity to engage in business development discussions to sell, license, or otherwise dispose of our rights to psilopenem, the protection provided by our patents, our ability to complete pre-commercialization activities for Orlynvah and prepare for a potential launch of Orlynvah by the fourth quarter of 2025, our ability to expand into new territories and put additional resources in high-prescribing geographies, and finally, our ability to raise funds either through a capital raise and/or revenue generated from sales of Orlynvah.
Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, and these include our ability to successfully prepare and implement commercialization plans for Orlynvah along with Eversana, our ability to build and maintain a sales force and to prepare for the commercial launch of Orlynvah on the timeline expected, the market opportunity for and the potential market acceptance of Orlynvah, the actions of third-party suppliers and manufacturers, our ability to continue as a going concern, the accuracy of our expectations regarding how far into the future our cash on hand will fund our ongoing operations, and finally, other factors discussed under the caption "Risk Factors," which is in our annual report on Form 10Q as filed with the SEC on May 13, 2025.
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. With that all said, I'll turn it over to you now, Corey.
Thanks, Kevin. Welcome, and thanks for joining us today. We wanted to take this opportunity to share some exciting updates on the business and our progress towards commercialization of Orlynvah. Before we begin that discussion, I want to reiterate what I had said on our last call. Our outreach to potential business development partners has yet to result in a transaction that the board views as acceptable, meaning being in the best interests of our shareholders. However, business development with another pharmaceutical company remains a potential opportunity for us at any point, and we remain open and excited to engage in those discussions as they arise. Having said that, we believe there is an urgency to bring Orlynvah to the U.S. market and therefore have been working diligently to prepare for a potential commercialization of Orlynvah.
As a first business update, I want to spend a minute and talk about our extension of the term of our promissory note due to Pfizer to be sure everyone understands how important this extension was to Iterum. Last month, we announced that Pfizer had agreed to extend the due date for payment of the $20 million regulatory milestone associated with Orlynvah's approval by the FDA. The promissory note was due in October of 2026 and is now due in October of 2029. This three-year extension removes the financial overhang of that potential payment from 2026 and provides the ability for any potential capital raised or potential revenue earned in the near term from sales of Orlynvah to be strategically reinvested to enable a successful launch, including the possibility of expanding into new territories or concentration of resources in high-prescribing geographies.
Now I'll share some updates regarding our commercialization plans for Orlynvah in the U.S. There's been a tremendous amount of work done over the last few months, and as you may have seen today, we announced that Iterum has signed a product commercialization agreement with Eversana, a leading provider of global services to the life sciences industry serving over 650 organizations. This agreement provides the opportunity to efficiently bring Orlynvah to the U.S. market. By leveraging existing Eversana resources across multiple functions and disciplines, Iterum has been able to streamline the time to launch and allows us to be in a position where we expect to launch by the fourth quarter of this year. As you may know, Orlynvah received FDA approval in October 2024 and is the first and only FDA-approved oral penem in the U.S.
It is indicated for the treatment of uncomplicated urinary tract infections in women who have limited or no other alternative oral treatment options. As we look at the uncomplicated urinary tract infection market where we expect Orlynvah will compete, there are a number of market dynamics that produce an environment that is supportive of potential strong adoption for a new oral agent with Orlynvah's characteristics. First, the uncomplicated urinary tract infection market in the U.S. is relatively large and, based on our research, generates approximately 40 million prescriptions annually in the U.S. Of those, we estimate that approximately two-thirds, or about 26 million prescriptions, are written for at-risk patients. At-risk patients are defined as women who are elderly, women with comorbidities like diabetes, heart failure, and cancer, or women with a history of recurrent infections.
We believe these at-risk patients are Orlynvah's addressable market, as they are likely the patients with limited or no other oral treatment options available and are the patients most in need of new therapies. A second market dynamic that exists is that there have been no new oral treatments in the uncomplicated urinary tract infection market in over 25 years. The space contains products that were approved 30 to 50 years ago, and the market leader in prescriptions, nitrofurantoin, was approved in 1953, over 70 years ago. This category truly is one which has been without advancements in the treatment for decades. The third market dynamic is that rising rates of antibiotic resistance are eroding the efficacy of these existing oral treatments.
The last market dynamic I'll mention today is that almost all of the existing oral products have safety challenges that physicians need to consider when choosing which product to prescribe. These challenges range from existing products not being recommended for use in uncomplicated infections to products being contraindicated in patients with low creatinine clearance. With these current market dynamics as a backdrop, we believe it's easy to understand the significant need for new, efficacious treatment alternatives to effectively treat all patients, and particularly those at-risk patients. Now I'd like to share with you a few of the highlights from market research that we conducted with physicians and payers. Physicians agree that there is a high unmet need for new antibiotics in the uncomplicated urinary tract infection space and report relatively low confidence and success with empiric treatments in at-risk patients.
Physicians believe Orlynvah can effectively address an unmet need in uncomplicated urinary tract infection management, and they believe the ideal patients for Orlynvah are the ones considered by providers to be at risk: those with recurrent uncomplicated urinary tract infections and prior antibiotic failures, those with comorbidities, or elderly patients with concomitant concerns. When we look at payer research, Orlynvah was viewed favorably for efficacy and safety, as well as the potential treatment of multi-drug resistant pathogens. Now let's spend a minute and talk about some of the important activities that are underway or have been completed in preparation for launch. Leveraging Eversana's resources, we have engaged and trained a team of national account managers on the uncomplicated urinary tract infection market and Orlynvah. This team's primary responsibility is to assure optimal market access for Orlynvah with payers and managed care organizations.
They are already in the field and have begun discussions with national and regional payers. Their initial conversations are centered around the uncomplicated urinary tract infection space and all of its dynamics, and of course, they are providing an overview of Orlynvah and its key attributes. As they complete those initial discussions, we intend to schedule clinical reviews and have in-depth contracting discussions and negotiations, as well as formulary reviews, in the coming months. As we think about Orlynvah's launch, we plan to execute in phases. In phase one, Orlynvah will be available to patients nationwide, and our field resources will be concentrated in a limited number of territories. We are finalizing the optimization of this territory alignment based on three key elements. The first element is the resistance rates in a particular territory. The second element is the number of high-value physician targets in a particular territory.
The third element is market access and physician access in a particular territory. It's important to note that as we are using the number of high-value physicians in a territory to help determine where we will put commercial resources, the opportunity for Orlynvah to generate prescriptions in target territories is potentially substantial. To provide a bit of context, our analysis estimates that each high-value physician in our target territories writes, on average, over 500 prescriptions for the treatment of uncomplicated urinary tract infections each year. As we look at pricing, we have not yet finalized our pricing strategy. However, we expect to set our wholesale acquisition costs, or our gross price before deductions, within the range established by other oral antibiotic launches for products that are used in other infection types. The range of this pricing is between $1,400 and $4,700 per course of treatment.
Importantly, at those gross prices, these products are enjoying solid market access from a managed care perspective. With regard to Salesforce activities, we have begun recruiting for district managers who are an integral part of the field organization. We expect to have the district managers on board soon, and once we finalize our territory alignment, we plan to recruit sales representatives. We are in late-stage discussions with potential distribution and patient services partners. These partners serve an important role in any commercialization, as they process the prescriptions and assure efficient and timely delivery of the product to the patient. The ability for a patient to begin therapy quickly in acute indications like uncomplicated urinary tract infections is very important. We were an exhibitor at our first Healthcare Congress meeting last month and unveiled Orlynvah to the external healthcare community.
We also plan to have a booth at the American Association of Nurse Practitioners Congress later this month in San Diego. Of course, the items I just highlighted are a few of the many activities embedded in our commercialization plan. We continue to work on a variety of other projects and functions to stay aligned with our proposed timelines for launch. Now I'd like to spend a couple of minutes talking about a few other areas of the business related to our commercialization as we continue to solidify additional pillars in support of the potential upcoming launch. On the intellectual property front, we have two types of protection for Orlynvah: marketing exclusivity as well as patents. On the marketing exclusivity front, the FDA has designated oral sulopenem, Orlynvah, as a qualified infectious disease product for uncomplicated urinary tract infections and a number of other indications.
In October of 2024, upon approval of Orlynvah, the FDA confirmed an additional five years of marketing exclusivity under the GAIN Act, resulting in a total of 10 years of marketing exclusivity in the U.S. from the date of approval. Therefore, the marketing exclusivity that FDA has granted Orlynvah will expire in October 2034. On the patent front for Orlynvah, we exclusively license from Pfizer one U.S. patent and three foreign patents. Additionally, we own four U.S. patents, one Japanese patent, one Korean patent, and two Australian patents, with one U.S. patent, the Japanese patent, the Korean patent, and one Australian patent directed to the composition of the bilayered tablet of oral sulopenem and its related preparations and/or uses. Two U.S. patents and one Australian patent are directed to the method of use of oral sulopenem in treating multiple diseases, including uncomplicated urinary tract infections. One U.S.
patent is directed to the method of use of sulopenem, probenecid, and valproic acid in treating multiple diseases. The patents owned by us are scheduled to expire between 2039 and 2041, excluding any additional term for patent adjustments or patent term extensions. We also own three pending U.S. patent applications and 26 pending foreign patent applications, which collectively cover uses of sulopenem and probenecid and bilayered tablets of sulopenem and probenecid. With the combination of marketing exclusivity and patent protection, we believe Orlynvah will have a very long runway to create value. The other area that we have made significant progress in is manufacturing and supply. We estimate that our current inventory on hand will provide product through mid- to late 2026.
An interesting and important note on supply of Orlynvah is that our commercial product, the bilayered tablet of oral sulopenem, has outstanding expiration dating, with a shelf life of six years from the date of manufacture. This provides an important advantage with distributors in the market, as many other competitors and potential new market entrants will likely have a shorter expiration timeframe. In closing, we have made tremendous progress to date towards the commercialization of Orlynvah. Along with our partner Eversana, we believe there is significant need for Orlynvah in the uncomplicated urinary tract infection market, and are anticipating making this first and only approved oral penem available to patients and physicians by the fourth quarter of this year. We look forward to providing you additional updates as we progress. Thanks for joining us today. Enjoy the rest of the day. That concludes today's conference call.
Thank you for your participation today. You may now disconnect your line.