8/14/2025

speaker
Operator

Good morning, ladies and gentlemen, and welcome to FinEx Pharmaceuticals' second quarter 2025 Earnings and Corporate Update conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions on how to participate will be given at that time. As a reminder, today's conference is being recorded. Now, I would like to turn the conference over to FinEx Chief Financial Officer, Robert Andrade.

speaker
Robert Andrade
Chief Financial Officer

Thank you, Operator, and good morning, everyone. Thank you for joining us. We are pleased to host Fennec Pharmaceuticals' second quarter 2025 earnings conference call today, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning is our chief executive officer and board member, Jeff Hackman. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements. that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views as of today only. and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days. And with that, I will now turn the call over to Jeff Hackman.

speaker
Jeff Hackman
Chief Executive Officer

Hey, thanks, Robert. Good morning, everyone. Thanks for joining the call today. Boy, it's hard to believe it's been one year since I stepped in into the CEO role here at Fennec. You know, when I joined, my focus was clear. I wanted to stabilize the business, sharpen our strategy, and build a strong foundation for sustainable growth. I'm proud to say that over the last 12 months, we've been delivering on these priorities, while also driving the awareness and adoption of PEDMARC for the prevention of cisplatin-induced ototoxicity, or CIO. And the results are beginning to materialize. We are now talking about three consecutive quarters of growth and more to come. You may recall after I joined FENIC last year, I outlined a focused set of strategic imperatives to drive our execution and accelerate the long-term growth of PEDMARC. which, remember, still remains the first and only FDA-approved therapy in the U.S. and Europe to reduce the risk of CIO or permanent hearing loss associated with cisplatin treatment. PEDMARC is specifically approved for pediatric patients one month of age and older with localized non-metastatic solid tumors and also is recognized by the National Comprehensive Cancer Network, or NCCN, with a two-way recommendation for use in adolescent and young adult patients. But before we dive into the performance for the quarter, let me update you on significant progress that we've made during the first half of this year. First, we've made significant strides in increasing awareness of the unmet need among both oncology and broader cancer care communities. We've done this through continued presence at major conferences, targeted educational campaigns, and peer-to-peer interactions. We're seeing growing recognition that hearing loss from cisplatin is not just a side effect, it's preventable, and it's an issue with long-term consequences. We're seeing the strongest momentum in both large community practices and academic centers, and early validation of our targeted sales approach and enhanced patient support services. And to that end, I'm pleased to share that a large national oncology group of providers recently added Pedmark to its formulary for its use in patients under 40 years of age. This is one of the largest and fastest growing groups in the country. It's a group of community-based oncology practices in the U.S. This decision reflects the growing recognition and the need to protect younger patients from cisplatin-induced hearing loss, and we're excited and encouraged by what it signals in terms of broader momentum for PEDMARC and adoption in the community settings. Second, we are actively working to cement PEDMARC as the standard of care for CIO prevention. During the second quarter, we held multiple advisory boards with leading academic centers across the country to better understand current approaches to diagnosing and managing CIO. The insights shared by key opinion leaders are now forming many of our cross-functional strategies. In parallel, positive feedback from existing accounts using PEDMARC continues to strengthen our confidence in our clinical value and support broader institutional adoption. I'm pleased to also share today that ENCODA recently issued a positive quality intervention, or PQI, for PEDMARC. This is an important development that provides peer-reviewed practical guidance to oncology care teams on the use, administration, and timing of PEDMARC to prevent CIO in pediatric and AYA or adolescent and young adult patients. ENCODA PQIs are widely used tools that support multidisciplinary cancer teams, including pharmacists, nurses, and oncologists, in delivering a high-quality care for patients receiving oral and IV therapies and oncology. But most importantly, we see PQI as a strong signal of growing clinical alignment around importance of preventing cisplatin-induced ototoxicity. And it supports our goal of establishing PEDMARC as the standard of care in this space. Third, we are expanding and educating on CIO and an important role of PEDMARC in preventing it, not just with oncologists, but beyond. Many healthcare professionals are involved in the patient's journey, including ENTs, audiologists, nurses, and pharmacists. These groups are now engaging with FENIC and PEDMARC, and we're seeing the benefit of this multidisciplinary support in day-to-day clinical practices. We are reminded that in the expansion that the care of these oncology patients, especially when it comes to survivorship and quality of life, it goes beyond the role of just the oncologist. Fourth point I want to make is on the access front. We've made significant progress with payers and providers alike. Our field access and reimbursement teams have been instrumental in ensuring smoother coverage and pathways and fewer barriers for the sites that are ready to treat. The strengthening of our Fennec HEERS patient assistance program has been central to this work. We've seen quarter over quarter growth in enrollment in Fennec HEERS programs and the newly revamped offerings that we're delivering, which are giving improved experiences through strengthened healthcare provider practices, patient services, expanded payer reimbursement support, and streamlined access to home nursing resources. And finally, on the activation side, while our near-term commercial focus remains on educating healthcare providers to support a shift in the standard of care, We are also strengthening our efforts to educate and engage patients and caregivers. We are doing this through the support of several advocacy associations or organizations, such as the Testicular Cancer Awareness Foundation and activities surrounding initiatives like the Childhood Cancer Awareness Month. These efforts help raise awareness of the risk of CIO and encourage families to inform and have informed conversations about hearing protection during their treatment planning. Further, we're excited to announce that Fennec's senior leadership team and employees, along with several PEDMARC patients and their families, will ring the closing bell of the NASDAQ stock market on Friday, September 5th, 2025. While this is an exciting business milestone for Fennec, it's a really important symbolic reminder of our mission, which is to help more patients be able to hear their own remission bells. Now, turning to our second quarter 2025 results. Revenue grew 33% year over year and 10% sequentially with net revenues of $9.7 million. This kind of quarter over quarter growth just doesn't happen by chance. It reflects a disciplined execution and a completely overhauled go-to-market strategy and having a top-down talent in the right positions to execute this excellence. This quarter, over quarter growth includes the addition of 14 new accounts, some of which are part of two large community oncology groups or purchase or GPOs. Within these networks, we've seen PEDMARC activation in Q2, which continues to grow into Q3. Looking into Q3, we expect additional accounts within both of these networks to activate and prescribe PEDMARC. I'm incredibly proud of the Fennec team and encouraged by the continued growth that we're seeing, which reinforces our belief in the scalability of this model and the growing demand for PEDMARC across these key markets. With that, I'll now turn it back over to Robert.

speaker
Robert Andrade
Chief Financial Officer

Thank you, Jeff. It's really amazing to think that just one year ago we did our first conference call together and the amount of progress to date under your leadership. I remember on that call both thanking our shareholders for their support and patience as we underwent the transition and stating that I believe the opportunity for Fennec was significant with proper execution ahead of us. I'd like to give much appreciation and recognition to our new leadership team that Jeff brought into Fennec only nine months ago and who have been on the front lines in this execution. Christy Chiaffi, our chief strategy officer and leader in many areas, including our awareness and marketing mission. Terry Evans, our chief commercial officer, who has primed our commercial team for optimal excellence. And Pierre Sayad, our chief medical officer, whose experience and knowledge has transformed our medical team with new energy and vigor and the proper tools to educate and support providers and patients. I believe we are just getting started. Now onto the details. Our press release contains some of our financial results for the second quarter of 2025, which can be viewed on the investors and media section of our website. Rather than read through all those details, my comments today will focus on some key financial results. As Jeff outlined, for the second quarter of 2025, the company recorded net product sales of $9.7 million, representing a 33% increase compared to the same period last year, and 10% growth over the first quarter of this year. and matching the highest quarterly net product sales in the history of Fennec. Of significance, we are pleased to report our third consecutive quarter of sequential growth in net product sales. We have a great trend forming. Our revenue performance continues to demonstrate strong growth and commercial momentum, and we believe this is just getting started. As mentioned in our previous earnings, we are focused on growing net product sales throughout 2025. Importantly, we anticipate the most significant quarterly growth in the second half of 2025, when all the foundational pillars and initiatives we have implemented and continue to optimize are expected to materially impact growth at Petmark. The strong performance reflects both successful retention of existing customers and the exciting new uptake and demand for Pedmark by new customers. Further, the launch of Pedmarksy by Norgene in the EU is well underway in the United Kingdom and Germany, and we are pleased with the traction to date. We expect to provide additional updates on milestones and royalties from this partnership with Norgene in the quarters to come. Turning to our expenses, our total cash operating expenses for the quarter exclude non-cash stock-based compensation with approximately $11 million. This represents an increase of roughly $2 million compared to the first quarter of this year. The quarter over quarter increase was primarily driven by ongoing investments in marketing, additional headcount, as well as continued efforts related to our intellectual property. As is customary with our business, cash operating expenses are higher in the first half of the fiscal year, largely as a result of commercial and marketing spending patterns. And we expect these cash expenses to decrease in the second half of 2025. The company recorded $4.4 million in selling and marketing expenses in the second quarter of 2025, compared to $2.9 million in the first quarter of 2025 and $4.7 million in the second quarter of 2024. The primary drivers of the increase in the quarter include additional marketing expenses and a one-time accrual reversal that occurred only in Q1 2025. On the G&A front, the company recorded $7 million in the second quarter of 2025 compared to $6.1 million in the earlier quarter of first quarter of 2025 and $6.9 million in the second quarter of 2024. For the second quarter of 2025, G&A expenses were consistent on a year-over-year basis and increased quarter-over-quarter largely due to the following. One, increased non-cash stock compensation, and two, ongoing litigation and intellectual property expenses. For the quarter, the company spent roughly $4 million in cash. Cash and cash equivalents were approximately $18.7 million as of June 30th, 2025. we remain confident that full-year cash operating expenses will be similar in 2025 to that of 2024, or roughly $33 million. This includes an increase in commercial expenses, including higher headcount and marketing expenses, offset by the elimination of European pre-commercialization costs, which only occurred in 2024. Importantly, we have several levers to potentially increase the cash balance in the second half of 2025. Product revenues continue to gain momentum, and we aim towards cash profitability as cash expenses also decrease in the second half. Two, potential milestones and royalties from the Norgene partnership. And three, the possible monetization for partnerships. after the release of the Japan study results, which are expected in the fourth quarter. An operator with that will now open up the call for questions.

speaker
Operator

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Chase Knickerbocker with Craig Hallam. Your line is now open.

speaker
Chase Knickerbocker
Analyst, Craig-Hallam

Good morning. Thanks for taking the questions. Jeff, maybe just to start, would you guys be willing to share an active prescriber's number, particularly, obviously, within AYA? It would be helpful to see the number of active prescribers you have within that kind of cohort.

speaker
Jeff

Yeah.

speaker
Jeff Hackman
Chief Executive Officer

Hi, Chase. How are you? Good morning. We don't share the number, you know, the cumulative number, obviously, for a bunch of different reasons on that guidance. Tell me a little bit more about what you're, maybe a little bit more detailed, though, and I can maybe share some other specifics, what you're looking for.

speaker
Chase Knickerbocker
Analyst, Craig-Hallam

Just an active number of, you know, current writers, basically. I mean, you shared kind of double-digit accounts you know, increase sequentially. I mean, maybe on that front, kind of, you know, if you'd be willing to share kind of an active account number, just as we can, so we can think about kind of the ramp from here in AYA.

speaker
Jeff Hackman
Chief Executive Officer

Yeah, yeah. Let me go back and look at that. It might be something that we might be able to share in the future quarters, Chase. You know, I don't see that, you know, I want to be careful about especially when you start getting a little bit more detail on actual accounts that are out there, and obviously you have to protect that relationship. But obviously doing something with some numbers might not be – it could be something we could do in the future.

speaker
Chase Knickerbocker
Analyst, Craig-Hallam

Maybe if we just focus on that double-digit account sequentially, Jeff. I mean, can you give us some kind of visibility into maybe how many patients within those accounts – in AYA are treated with cisplatin, kind of what your kind of overall opportunity is, maybe just in those accounts that have kind of added on sequentially?

speaker
Jeff Hackman
Chief Executive Officer

Yeah, I mean, we talked about, you know, in the AYA market, it's 10 times the size of the pediatric. It's about 20,000 patients in that population between, you know, ages 15 to 39 that are treated with cisplatin. And so that population is significant. That's our market. That's where we've divided up the country into our commercial teams and supplied them with that data.

speaker
Robert Andrade
Chief Financial Officer

Yeah, and Chase, I'll add, which is important. It starts generally with one patient at a center or at a hospital. We have successful administration. we can create the awareness, we have successful administration, and we have successful reimbursement, that expands. And what we've witnessed in particular in Q2 over Q1 is the retention of those existing customers and that also augmenting the amount of patients within those existing customers. So I think where we wanted to shed light was we had 14 new accounts. Don't get focused on the amount of accounts because each account is unique, but we are growing. And the goal is obviously then to build that existing base and augment that as well.

speaker
Chase Knickerbocker
Analyst, Craig-Hallam

Maybe just a little bit of additional color on that. When that account starts out, and let's say it's a single patient, what's kind of the cadence in which you start seeing increased writing from said account?

speaker
Jeff Hackman
Chief Executive Officer

Yeah, we see it. We saw it more in the second quarter as we started to get experience, Chase. That's exactly where Robert was going, was we needed to have that initial patient in that center or that practice go through, you know, PEDMAR therapy, see the positive outcome, see that it works, how they administer it, in some cases actually using our PhenicHears program. And now we, you know, that's the area where obviously a lot of our folks will focus their efforts is to expand now in those same practices. Because remember, these physicians and these oncology practices have multiple cisplatin patients that they're going through. So that's where we saw a lot of our growth was through expansion of current accounts in Q2. And we'll see even more of that as we go through the year.

speaker
Chase Knickerbocker
Analyst, Craig-Hallam

Got it. Maybe just last for me, guys. Sorry to get somebody in here. But on the EU side, could you share the amount of royalty revenue that was in the quarter from Norgene? And then just kind of general thoughts on kind of how that ramp is going with your partner, particularly as we go into the back half of the year here. And then on kind of final German pricing, I mean, do you have a thought on when we should hear back on that? Thanks for taking the questions.

speaker
Robert Andrade
Chief Financial Officer

Yeah, thanks, Chase. To step back a little, as you're aware, the Norgene partnership has two primary components. The first component are the royalties, and that is a percent starts in the mid-teens of Norgene sales. And the second component is north of 200 million potential milestones. We started to see some significant traction in the second quarter from that partnership. As a reminder, they launched late in the first quarter. The second quarter, we started to see some traction really out of the UK as they worked to get the different P&T approvals within Germany and final pricing later in the year. That number is not material enough at this point to move our own financials in an aggregate basis. but the sequential certainly increase in traction is significant. They plan to then roll that out to the broader EU5 later this year, early next year. You're talking Italy, Spain, France, and also to the Nordic regions. We're quite enthusiastic about that opportunity. Near term, there are two primary milestones ahead of us. One is based on aggregate calendar year sales. And the other one is based on German pricing. And we look forward to giving updates on that in the quarters to come.

speaker
Chase Knickerbocker
Analyst, Craig-Hallam

Thanks, guys.

speaker
Operator

Thank you. Our next question comes from the line of student Logan Nathan with Stevens. Your line is now open.

speaker
Logan Nathan
Analyst, Stephens Inc.

Hi, good morning. Congrats on the progress in the second quarter, and thank you for taking my questions. My first one wanted to just get some color on the mix of new and repeat customers. Maybe you can provide a percentage amount of either to kind of get a look at the potential net penetration and how that's progressing.

speaker
Jeff Hackman
Chief Executive Officer

Yeah, initially when we started, we jumped out to mostly new customers, right? So we saw, you know, I mean, if I... I could give you percentages when we first started in the AYA space, all of our customers were new, right? We really got out and tried to get experience with Pedmark in these patients. We saw in the second quarter now that start to shift down to some higher percentages of these repeat customers. And so we will see, you know, we're... I don't want to give a percentage because it's a moving target as we go, but we are seeing new patients coming in. We talked about 14 new accounts. We talked about growing these new accounts, and it's really critical for us because there are so many accounts out there not touching Petmark. So I think we'll continue to see this new account additions, but as we grow our business and get bigger, we'll start, you'll add those additional accounts behind those that are repeat customers. At this point, we're starting to see the mix start to even out a little bit more, new customers versus repeat customers, and we'll probably continue to see that throughout the rest of this year.

speaker
Logan Nathan
Analyst, Stephens Inc.

Great, I appreciate that caller. The second one I wanted to ask here is, you know, with the trial results in Japan expected this fall, could you elaborate on the Japanese market opportunity? You know, for example, the prevalence of CIO in both pediatric and AYA populations, and then outline your plans for a potential commercial rollout, including whether you anticipate partnering locally or the size of the sales force you may implement there in that region.

speaker
Jeff Hackman
Chief Executive Officer

Right. So we're in the final discussions of trying to understand all the data. We'll have some meetings in September here with the investigators to really kind of go through all the data tables and get ourselves familiar with that. So that's the first part is just really making sure we understand and get all the data. We are working with... our investigators as well as with some consultants to kind of start to look at, okay, what's our approach? What is our regulatory approach and how fast do we get this product submitted? As you know, in Japan, you'll need a partner to submit it to the PDMA. And so we're looking at that approach and that partner strategy in parallel. We've said this before, we're in discussions with folks And that's an ongoing process as we move forward. Japan's about a third of the size of the US and Europe when you look at CIO usage. And so that kind of gives you a feel for the numbers. Remember, this will be probably a pediatric indication in Japan. We had 10 centers that participated in the trial. These centers are all excited about getting an opportunity to continue to use this product outside of the clinical trial. So we've had some really good feedback from the folks in-country. So there's more to come here. We'll probably have more updates in September. as we see some of the final data and how we're going to approach this. Timing-wise, we're trying to really focus it as fast as we can move this forward. We don't want these investigators and folks in Japan who have touched this product to go a long time without having to be able to have an approved product, right? So the faster we can get this into the Japanese regulatory authorities, the better.

speaker
Robert Andrade
Chief Financial Officer

Yeah, and just to add, we've had a lot of enthusiasm from investigators, from patients, and a lot of unsolicited interest within Japan and the broader Asia area for the product. It's a known product. It's known to work. The reimbursement system is quite sophisticated. Having been through the NORDGEN process a year ago, I think it's quite analogous to it. So, we look forward to giving more updates.

speaker
Logan Nathan
Analyst, Stephens Inc.

Great to hear. Just lastly, if I can squeeze one more in, do you anticipate the operating expenses to remain relatively stable in the second half of the year, and what areas do you expect will represent Maybe your largest expenditures in the upcoming quarters may drive those expenditures. I know you mentioned, obviously, the IP expense needed for the EU in the second quarter. And I'm just kind of curious if there's any more, you know, kind of maybe one-time expenses in the second half of this year as you're growing the launch.

speaker
Robert Andrade
Chief Financial Officer

Yeah, thank you. So the first half of the year is heavier from a cash optics. A lot of our contracts are structured with 50% up front. and then the balance over the back half of the year. So as mentioned in the stated remarks, I expect both our second half expenses to go down. So from our cash operating expenses, we're at roughly 20 million for the first half, so I expect it to go down. And the full year to be consistent with 24 from a cash op-ex, which was roughly 33 million to 34 million. In the second quarter specifically, On a non-cash basis, there was also a jump up in stock-based compensation as we aligned what we believe is a really effective and exciting team here with incentives that are aligned with our shareholders.

speaker
Logan Nathan
Analyst, Stephens Inc.

Great. Thanks. I really appreciate all the insight here. Again, congratulations.

speaker
Operator

Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is now open.

speaker
Chad
Analyst, Maxim Group

Hi, guys. Thanks for taking the questions. This is Chad on for Jason. We were wondering if you could provide some additional color on getting the PQI and how this differs from NCCN guidelines.

speaker
Jeff

Sure. Hey, Chad. How are you?

speaker
Jeff Hackman
Chief Executive Officer

Nice to hear from you. Yeah, they differ. Let me see. The ENCODA PQIs are a peer-reviewed guidance document, really, and it really is a guidance document to really help patient care and oncology practices. It's a little bit different because it comes from the ENCODA stands for the National Community Oncology Dispensing Association. These are standardized, evidence-based kind of practice management type of recommendations. So they're a little bit more focused than the NCCN guidelines. And the purpose of these PQIs, we call them, are to kind of really focus on patient outcomes and really look at standardizing care and optimizing treatments and enhancing communications with the oncology teams. And so they're a little bit more focused, they're a little bit below the level of these NCCN guidelines. They cover various aspects, not just cancer care, but also kind of how to select patients or monitoring or counseling or management strategies. And so we really think that this is an important milestone for us to now have PQI for PEDMARC. They have now, you know, that's access. People can have information about our products really, you know, without us having to be there. They can access that information through these PQIs. So, we're very excited about it.

speaker
Chad
Analyst, Maxim Group

Thanks. That was helpful. And then also, could you talk about how you're splitting, you know, marketing resources between the larger AYA opportunity and earlier pediatric population? Are you, you know, laser focused on driving this newly open market, or is there some balance you're targeting there?

speaker
Jeff Hackman
Chief Executive Officer

Yeah, the balance between the two markets. I mean, listen, we've said all along that we believe that the opportunity is much larger in AYA, but that we don't – especially in the academic institutions. When we're in an academic institution, we're there on the pediatric side as well as the AYA side. Obviously, we know that the size and the market is much different, but there's still that incredible need for ped marks in these pediatric settings. And so we still continue to get used there. We still continue to see growth. We don't see the growth that we see in AYA, of course, because they're in this launch phase, and it's obviously much larger. But we instruct our commercial organization as well as our medical organization. When we're in these institutions, we're doing both PEDE and AYA commercial marketability.

speaker
Robert Andrade
Chief Financial Officer

Yeah, and just to add, Chad, doors have opened for us in the AYA as a result of our pediatric relationships that we've obviously built over the last several years. And conversely, doors have also opened for pediatric as a result of the progress that we've made with AYA. And so that's really the beauty of the opportunity. Different size market opportunities, but really growth potential in each one.

speaker
Jeff

Okay, great. Thanks, guys. That's all for me. Congrats again. Thanks.

speaker
Operator

Our next question comes from the line of Ram Selvaraju with HC Wainwright. Your line is now open.

speaker
Eduardo
Analyst, H.C. Wainwright

Hi, good morning. This is Eduardo on for ROM. I was wondering if you could provide any details that you, how proactive the FDA has been recently in seeking to ensure that the market is complying with its guidance not to substitute Piedmont with other compounded versions of your API and that formulation?

speaker
Jeff Hackman
Chief Executive Officer

I missed the beginning of that. I'm sorry, Eduardo. Can you repeat that again? Sorry.

speaker
Eduardo
Analyst, H.C. Wainwright

Sure, no problem. Just how proactive the FDA has been in ensuring the market is complying with its guidance not to substitute PEDMARC with compounded versions of STS.

speaker
Jeff Hackman
Chief Executive Officer

Well, you know, we've had a, you know, in the past, we've had the FDA, you know, put out a statement. I think that statement was clear. We, that statement is part of, you know, what we continue to utilize when we see that, you know, compounding happening. You know, they are, the FDA has been supportive of the use of, you know, FDA approved product or PEDMARC in this situation. So, I mean, it continues to, It would be probably one of the bigger areas in the pediatric discussion when we are looking at, you know, especially opening up new institutions. We want to make sure, and we talk about it all the time, about that we're the only FDA-approved product that's on the market. I think it's important to realize in the AYA space, unlike the pediatric space, is that the reimbursement and the usage of of compounded products are much different in the community settings as well. So we don't have as much of an issue there as we do in some of the academic centers in the pediatric space. But we continue to utilize that message from the FDA and continue to have support from them.

speaker
Robert Andrade
Chief Financial Officer

When I mentioned briefly our medical team, they have really reinvigorated both the fact that Pedmark is the first and only approved product for the prevention of hearing loss as it relates to cisplatinum. Also, understanding very well why cisplatinum causes this hearing loss, what the uniqueness is of Pedmark. And we've started to see that bear fruit just in recent quarters, and we expect more to come And we've got a lot of enthusiasm, as Jeff mentioned, both in new pediatric patients and also in AYA. And in AYA specifically, we have seen no compounded use of the product today.

speaker
Eduardo
Analyst, H.C. Wainwright

Got it. That's really helpful. And then going back to the EU, I think you mentioned the timeline for expanding. You mentioned you started with Um, Laura Jean had started the work and found some good traction with, in the UK markets. Could you, um, repeat the timeline for when you expect them to launch? And you mentioned Italy, I think, and a few other countries. Um, but yeah, just a little bit more clarity on that timeline again.

speaker
Robert Andrade
Chief Financial Officer

Sure. So as a reminder, nor Jean has the right to all of the EU, Australia and New Zealand. Um, principally that first market is the UK. They have also launched and they have their first patient in Germany, but there is not final pricing yet in Germany. There's only final pricing in the UK currently. The additional, as they call the EU5 markets on top of Germany, UK, where you have Italy, Spain, and France, we expect a launch early next year with preparation later this year. And the Nordic countries, Denmark, Norway, and additionally Switzerland, starting to come on later this year and early next year.

speaker
Jeff

In summary, they're just getting going. They're just getting started, which we're very excited about.

speaker
Jeff Hackman
Chief Executive Officer

Yeah, we're encouraged about the positive indications that we've seen in the early engagement.

speaker
Eduardo
Analyst, H.C. Wainwright

Got it. And do you have any visibility to the Germany pricing? That would trigger a milestone payment, is that correct?

speaker
Robert Andrade
Chief Financial Officer

That is a material milestone. We look forward to providing additional updates. What we do have is we have final pricing in the UK, which well exceeded what we were anticipating just a year ago. And so if we're consistent with that in Germany, we look forward to giving additional updates on that milestone.

speaker
Eduardo
Analyst, H.C. Wainwright

Got it. Thanks for answering the question. Thank you.

speaker
Operator

And I'm currently showing no further questions at this time. I'd like to turn the call back over to Jeff Hackman for closing remarks.

speaker
Jeff

Well, thank you. Thanks for your questions, everybody. I appreciate it, and the continued engagement.

speaker
Jeff Hackman
Chief Executive Officer

You know, as you heard today, we are so pleased with the momentum that we've been able to build in the first half of 2025. The revenue growth, The strong revenue growth that we've seen is the key to really all of the milestones that we've been able to achieve. We remain focused on the discipline execution that we've talked about today, the strategic imperatives, and we're confident on the path ahead. So, you know, most importantly, I'll close the call. I never want to lose sight of the patients that we serve, especially the young people facing cancer treatment and the difference that our product, Pedmark, can make in preserving their hearing and their quality of life. So we appreciate your support. We look forward to updating more on our continued progress in the quarters to come, and thank you for participating today.

speaker
Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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