NASDAQ:FENC Adherex Technologies Q2 2025 Earnings Report $8.20 -0.16 (-1.91%) Closing price 04:00 PM EasternExtended Trading$8.20 +0.01 (+0.06%) As of 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Adherex Technologies EPS ResultsActual EPS-$0.11Consensus EPS -$0.06Beat/MissMissed by -$0.05One Year Ago EPSN/AAdherex Technologies Revenue ResultsActual Revenue$9.76 millionExpected Revenue$9.52 millionBeat/MissBeat by +$240.00 thousandYoY Revenue GrowthN/AAdherex Technologies Announcement DetailsQuarterQ2 2025Date8/14/2025TimeBefore Market OpensConference Call DateThursday, August 14, 2025Conference Call Time8:30AM ETUpcoming EarningsAdherex Technologies' Q3 2025 earnings is scheduled for Thursday, November 6, 2025, with a conference call scheduled at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Adherex Technologies Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 14, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Revenue grew 33% year-over-year and 10% sequentially to $9.7M, marking a third consecutive quarter of growth. Positive Sentiment: A large national oncology group added Pedmark to its formulary, validating adoption in community practices for patients under 40. Positive Sentiment: INCOTA issued a Positive Quality Intervention (PQI) for Pedmark, offering peer-reviewed guidance to standardize CIO prevention in oncology care teams. Positive Sentiment: Norgene’s EU launch showed early traction in the UK and initial German patient use, with milestone payments and royalties expected as pricing is finalized. Negative Sentiment: Cash operating expenses rose to $11M this quarter (excluding stock compensation), driven by marketing, headcount, and IP efforts, though they expect H2 reduction. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallAdherex Technologies Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xThere are 7 speakers on the call. Operator00:00:00Good morning, ladies and gentlemen, and welcome to the Fintech Pharmaceuticals Second Quarter twenty twenty five 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 Fenics' Chief Financial Officer, Robert Andrade. Speaker 100:00:24Thank you, operator, and good morning, everyone. Thank you for joining us. We are pleased to host Fenics Pharmaceuticals second quarter twenty twenty five earnings conference call today, during which we will review our financial results as well as provide a general business update. Joining me from Fenics 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. Speaker 100:01:07Reference 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. Speaker 100:01:41This conference call is being recorded for audio rebroadcast on Fenics website, www.fennecpharma.com, where it will be available for the next thirty days. And with that, I will now turn the call over to Jeff Hackman. Speaker 200:02:01Thanks, Robert. Good morning, everyone. Thanks for joining the call today. Well, it's hard to believe it's been one year since I stepped in into the CEO role here at Fenwick. When I joined, my focus was clear. Speaker 200:02:15I 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 twelve months, we've been delivering on these priorities, while also driving the awareness and adoption of Pedmark 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 PetMark, which remember still remains the first and only FDA approved therapy in The U. Speaker 200:03:00S. And Europe to reduce the risk of CIO or permanent hearing loss associated with Cisplatin treatment. Headmark 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 2A recommendation for The U. S. For use in adolescent and young adult patients. Speaker 200:03:31But 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, an early validation of our targeted sales approach and enhanced patient support services. Speaker 200:04:19And 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 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 Pedmark and adoption in the community settings. Speaker 200:04:57Second, we are actively working to cement Pedmark 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 PedMark continues to strengthen our confidence in our clinical value and support broader institutional adoption. I'm pleased to also share today that ENCOTA recently issued a positive quality intervention or PQI for Pedmark. Speaker 200:05:42This is an important development that provides peer reviewed practical guidance to oncology care teams on the use administration and timing of Pedmark to prevent CIO in pediatric and AYA or adolescent young adult patients. Encoder 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 in 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 PEDmark as the standard of care in this space. Third, we are expanding our CIO and we are expanding and educating on CIO and an important role of Pedmark, in preventing it, not just, with oncologists, but beyond. Speaker 200:06:43Many healthcare professionals are involved in the patient journey, including ENTs, audiologists, nurses and pharmacists. These groups are now engaging with FENIC and PEDmark, 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. Speaker 200:07:20Our 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 Phenic Hears patient assistance program has been central to this work. We've seen quarter over quarter growth in enrollment in KEAR's programs and the newly revamped offerings that we're delivering, which are giving improved experiences through strengthened health care provider practices, patient services, expanded payer reimbursement support and streamlined access to home nursing resources. And finally, 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. Speaker 200:08:28These 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 are excited to announce that Fenics senior leadership team and employees along with several Pedmark patients and their families will ring the closing bell of the NASDAQ stock market on Friday, 09/05/2025. While this is an exciting business milestone for FENIC, it's important 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 twenty twenty five results. Revenue grew 33% year over year and 10% sequentially with net revenues of 9,700,000.0 This kind of quarter over quarter growth just doesn't happen by chance. Speaker 200:09:25It 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 Pedmark 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 Pedmark. I'm incredibly proud of the FENIC 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 Pedmark across these key markets. Speaker 200:10:18With that, I'll now turn it back over to Robert. Thank you, Jeff. Speaker 100:10:24Really 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 was significant with proper execution ahead of us. Further, I'd like to give much appreciation and recognition to our new leadership team that Jeff brought into FENIC 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 initiatives. Speaker 100:11:11Terri Evans, our Chief Commercial Officer, who has primed our commercial team for optimal excellence. And Pierre Saias, 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 on to the details. Our press release contains some of our financial results for the 2025, which can be viewed on the Investors and Media section of our website. Speaker 100:11:50Rather than read through all those details, my comments today will focus on some key financial results. As Jeff outlined, for the 2025, company recorded net product sales of 9,700,000.0 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 Senec. 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. Speaker 100:12:47As 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 2025. When all the foundational pillars and initiatives we have implemented and continue to optimize are expected to materially impact growth of Edmark. 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 Norgeme in The EU is well underway in The United Kingdom and Germany, and we are pleased with the traction to date. Speaker 100:13:41We expect to provide additional updates on milestones and royalties from this partnership with Norgeen in the quarters to come. Turning to our expenses. Our total cash operating expenses for the quarter exclude non cash stock based compensation, was approximately $11,000,000 This represents an increase of roughly $2,000,000 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 2025. Speaker 100:14:46The company recorded $4,400,000 in selling and marketing expenses in the 2025 compared to $2,900,000 in the 2025 and $4,700,000 in the 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 twenty twenty five. On the G and A front, the company recorded $7,000,000 in the 2025 compared to $6,100,000 in the earlier 2025 and $6,900,000 in the 2024. For the 2025, G and 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 $4,000,000 in cash. Speaker 100:15:56Cash and cash equivalents were approximately $18,700,000 as of 06/30/2025. We remain confident that full year cash operating expenses will be similar in 2025 to that of 2024 or roughly $33,000,000 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 2025. Product revenues continued 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 Norgeme partnership and three, the possible monetization for partnership after the release of the Japan study results, which are expected in the fourth quarter. Speaker 100:17:03And operator, with that, we will now open up the call for questions. Thank Operator00:17:24Our first question comes from the line of Chase Knickerbocker with Craig Hallum. Your line is now open. Speaker 300:17:30Good morning. Thanks for taking Speaker 100:17:32the questions. Jeff, maybe just to start, can would you guys be willing to Speaker 300:17:36share an active prescribers number, particularly obviously within AYA? It would be helpful to see kind of the number of active prescribers you have within that kind of cohort. Speaker 200:17:55Yes. Hi, Chase. How are you? Good morning. We don't share the number, the cumulative number, obviously, for a bunch of different reasons on that guidance. Speaker 200:18:08Tell me a little bit more about what you're maybe a little bit more detail though, and I can maybe share some other specifics, if what you're looking for. Speaker 300:18:18Just an active number of current writers basically. I mean, shared kind of double digit accounts increase sequentially. Mean, maybe on that front, kind of 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. Yes. Speaker 200:18:41Let me go back and look at that. It might be something that we might be able to share in the future quarters, Chase. I don't see that I want to be careful, especially when you start you know, getting a little bit more detail, right, on actual accounts that are out there. And obviously, you have to protect that relationship. But but obviously, doing something with with some numbers might not be you know, it could be something we could do in the future. Speaker 200:19:07So Speaker 300:19:08maybe if we just focus on that double digit accounts 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 200:19:30Yes. I mean, we talked about in the AYA market, it's 10 times the size of the pediatric. It's about 20,000 patients in that population between ages 15 to 39 that are treated with Cisplatin. And so that population is significant. That's our market. Speaker 200:19:50That's where we've divided up the country into our commercial teams and supplied them with that data. Speaker 100:20:01Yeah. And Chase, I'll add, which is important though. 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 been able 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. Speaker 100:20:34So 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 300:20:50Maybe just a little bit 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 200:21:06Yes, 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 as we needed to have that initial patient in that center or that practice go through, know, PetMar therapy, see the positive outcome, see that it works, how they administer it, in some cases actually using our Fenocears program. And now we 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 300:22:07Got it. Maybe just last for me guys. Sorry to get so many in here. But on the EU side, could you share the amount of royalty revenue that was in the quarter from Norgeen? 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? Speaker 300:22:28And then on the 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 100:22:38Yes. Thanks, Chase. To step back a little, as you're aware, the Norgene partnership has two primary components. The first component is are the royalties, and that is a percent, starts in the mid teens of Norgene sales. And the second component is north of 200,000,000 potential milestones. Speaker 100:23:04We 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 work to get the different P and 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 and traction, is significant. Speaker 100:23:43They plan to then roll that out to the broader EU five, later this year, early next year. So you're you're talking Italy, Spain, France, and also to the Nordic regions. So 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. Speaker 100:24:10And we look forward to giving updates on that in the quarters to come. Speaker 300:24:16Thanks guys. Operator00:24:18Thank you. Our next question comes from the line of Sudan Loganathan with Stephens. Your line is now open. Speaker 400:24:26Hi, 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 200:24:47Yes. Initially, when we started, we jumped out to mostly new customers, right? So we saw I mean, if 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. Speaker 200:25:22And so we will see we're we 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 PetSmart. So I think we'll continue to see this new account additions. Speaker 200:25:52But as we grow our business and get bigger, we'll start you'll add those additional accounts behind those that are repeat customers. So at this point, it's, 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 400:26:16Great. I appreciate that color. Second one I wanted to ask here is, with the trial results in Japan expected this fall, could you elaborate on the Japanese market opportunity? For example, the prevalence of CIO in both pediatric and AYA population? 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 200:26:42Right. 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, it's really making sure we understand and get all the data. We are working with the our investigators as well as with some consultants to kind of start to look at, okay, what's our approach? Speaker 200:27:14What is our regulatory approach? And how fast do we want to get this product submitted? As you know, in Japan, you'll need a partner to submit it to the PDMA. And so we're doing we're looking at that approach of that partner strategy in parallel. We're in we've said this before, we're in discussions with folks. Speaker 200:27:35And that's an ongoing process as we move forward. Japan is about a third of the size of The U. S. And Europe when you look at CIO usage. And so that kind of gives you a feel for numbers. Speaker 200:27:56Remember, this will be a probably a pediatric indication in Japan. We had 10 centers that were that participated in the trial. A 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. Speaker 200:28:26We'll probably have more updates in September as we see some of the final data and then 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. The faster we can get this into the Japanese regulatory authorities, the better. Speaker 100:29:01Yes. 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 it's a known product. It's known to work. The reimbursement system is is quite sophisticated. Speaker 100:29:25Having been through the Norgene process a year ago, I think it's it's quite analogous to it. So we look forward to giving more updates. Speaker 400:29:35Great 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 in what areas do you expect will represent maybe your larger expenditures in the upcoming quarters and may drive those expenditures? I know you mentioned, obviously, some of the IP, expense needed for the EU, in the second quarter. Speaker 400:29:55And I was 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 100:30:03Yes. Thank you. So the first half of the year is heavier from a cash OpEx. A lot of our contracts are structured with 50% upfront and then the back in the balance over the back half of the year. So I I as as mentioned in the in the stated remarks, I expect both our second half expenses to go down. Speaker 100:30:27So from a cash operating expenses, we are roughly 20,000,000 for the first half, so I expect it to go down. And the full year to be consistent with '24 from a cash OpEx, which was roughly 33,000,000 to 34,000,000. In the second quarter, specifically, on a noncash 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 400:31:01Great. Thanks. I really appreciate all the insight here. Again, congrats on the second quarter. Operator00:31:08Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is now open. Speaker 500:31:16Hi, 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 200:31:31Sure. Hey, Chad. How are you? Nice to nice to hear from you. Yeah, they differ. Speaker 200:31:40Let me say ENCOTA PQIs are a peer reviewed guidance document, really. And it really is a guidance document to really help patient care and oncology practices. So it's a little bit different because it comes from ENCOTA stands for the National Community Oncology Dispensing Association. So these are kind of these are standardized evidence based kind of practice management type of recommendations. So they're a little bit more focused than the NCCN guidelines, right? Speaker 200:32:19And 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 a PQI for Pedmark. They have now that's access people can have information about our products really without us having to be there. Speaker 200:33:08Can access that information through these PQIs. So we're very excited about it. Speaker 500:33:17Thanks. That was helpful. And then also, could you just talk about how you're splitting marketing resources between the larger AYA opportunity and earlier pediatric population? Are you laser focused on driving Or is there some balance you're targeting there? Speaker 200:33:38Yes, the balance between the two markets. I mean, Wilson, 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 PedMark in these pediatric settings. And so we still continue to get used there. Speaker 200:34:12We still continue to see growth. We don't see the growth that we see in AYA, of course, because during 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 ped and AYA commercial marketability. Speaker 100:34:34Yes. 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 500:35:06Okay, great. Thanks guys. That's all for me. Congrats again. Operator00:35:10Thanks. Yes, thanks. Our next question comes from the line of Ram Selvaraju with H. C. Wainwright. Operator00:35:16Your line is now open. Speaker 600:35:19Hi, good morning. This is Eduardo on for Ram. 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 200:35:41I missed the beginning of that. I'm sorry, Eduardo. Can you repeat that again? Sorry. Speaker 600:35:48Sure. No problem. Just how proactive the FDA has been in ensuring the market is complying with its guidance, not to substitute ped mark with compounded versions of STS? Speaker 200:36:02Well, know, we've had a you know, in the past, we've had the FDA, put out a statement. I think that statement is clear. We, that statement is part of what we continue to utilize when we see that compounding happening. They are the FDA has been supportive of the use of FDA approved product or Pedmark in this situation. So I mean, it continues Eduardo to be probably the one of the bigger areas in the pediatric discussion when we are looking at especially opening up new institutions, we want to make sure and we talk about it all the time about that there is a we're the only FDA approved product that's on the market. Speaker 200:36:51I think it's important to realize in the AYA space, unlike the pediatric space is that the reimbursement and the usage 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 for in the pediatric space. But we continue to utilize, that message from the FDA and continue to have support from them. Eduardo, Speaker 100:37:26when I mentioned briefly, you know, our medical team, they have really reinvigorated both the fact that Penmark is the first and only approved product for the prevention of hearing loss as it relates to cisplatin. Also, understanding very well why cisplatin causes this hearing loss, what the uniqueness is of Penmark. And we started to see though 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 600:38:13Got it. That's that's really helpful. And then, going back to the EU, I think you mentioned, the timeline for expanding. You mentioned you started with, Neurogene had started the work and found some good traction within The UK markets. Could you, repeat the the timeline for when you expect them to launch? Speaker 600:38:32And you mentioned Italy, I think, and a few other countries. But, yeah, just a little bit more clarity on that timeline again. Speaker 100:38:38Sure. So as a reminder, Norgeen has the right to all of the EU, Australia and New Zealand. 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. Speaker 100:39:01The 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. In summary, they're just getting going. They're just getting started, which we're very, very excited about. Speaker 200:39:34Yeah. We're encouraged about the positive indications that we've seen in the early engagement. So Speaker 600:39:40Got it. And do you have any visibility to the Germany pricing that would trigger a milestone payment? Is that correct? Speaker 100:39:46That 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, you know, just a year ago. And so if we were consistent with that in Germany, we look forward to giving additional updates on that milestone. Speaker 600:40:14Got it. Thanks for answering the question. Congrats on the quarter. Operator00:40:18Thank you. 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 200:40:29Well, thank you. Thanks for your questions, everybody. I appreciate it and the continued engagement. As you heard today, we are so pleased with the momentum that we've been able to build in the 2025. This 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. Speaker 200:40:55We remain focused on the disciplined execution that we've talked about today, the strategic imperatives, and we're confident on the path ahead. So, 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 you more on our continued progress in the quarters to come. Speaker 200:41:25And thank you for participating today. Operator00:41:29This concludes today's conference call. Thank you for your participation. You may now disconnect.Read morePowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Adherex Technologies Earnings HeadlinesAdherex Technologies (NASDAQ:FENC) Given New $14.00 Price Target at Craig HallumAugust 17 at 2:26 AM | americanbankingnews.comFennec Pharmaceuticals Reports Second Quarter 2025 Financial Results And Provides Business UpdateAugust 14, 2025 | globenewswire.comBREAKING: The House just passed 3 pro-crypto bills!THREE pro-crypto bills just passed the House! Now, experts believe altcoin season is officially here. August 18 at 2:00 AM | Crypto 101 Media (Ad)Adherex Technologies (NASDAQ:FENC) Cut to Hold at Wall Street ZenAugust 12, 2025 | americanbankingnews.comFennec Pharmaceuticals to Report Second Quarter 2025 Financial Results on August 14, 2025August 11, 2025 | globenewswire.comAdherex Technologies (FENC) to Release Earnings on TuesdayAugust 10, 2025 | americanbankingnews.comSee More Adherex Technologies Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Adherex Technologies? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Adherex Technologies and other key companies, straight to your email. Email Address About Adherex TechnologiesFennec Pharmaceuticals Inc., a biopharmaceutical company, develops product candidates for use in the treatment of cancer in the United States. Its lead product candidate is the Sodium Thiosulfate, which has completed the Phase III clinical trial for the prevention of cisplatin induced hearing loss or ototoxicity in children. The company was formerly known as Adherex Technologies (NASDAQ:FENC) and changed its name to Fennec Pharmaceuticals Inc. in September 2014. Fennec Pharmaceuticals Inc. was founded in 1996 and is based in Research Triangle Park, North Carolina.View Adherex Technologies ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Green Dot's 30% Rally: Turnaround Takes Off on Explosive EarningsElbit Systems Jumps on Record Earnings and a $1.6B ContractBrinker Serves Up Earnings Beat, Sidesteps Cost PressuresWhy BigBear.ai Stock's Dip on Earnings Can Be an Opportunity CrowdStrike Faces Valuation Test Before Key Earnings ReportPost-Earnings, How Does D-Wave Stack Up Against Quantum Rivals?Why SoundHound AI's Earnings Show the Stock Can Move Higher Upcoming Earnings Home Depot (8/19/2025)Medtronic (8/19/2025)Analog Devices (8/20/2025)Synopsys (8/20/2025)Lowe's Companies (8/20/2025)TJX Companies (8/20/2025)Intuit (8/21/2025)Workday (8/21/2025)Alibaba Group (8/21/2025)Walmart (8/21/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 7 speakers on the call. Operator00:00:00Good morning, ladies and gentlemen, and welcome to the Fintech Pharmaceuticals Second Quarter twenty twenty five 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 Fenics' Chief Financial Officer, Robert Andrade. Speaker 100:00:24Thank you, operator, and good morning, everyone. Thank you for joining us. We are pleased to host Fenics Pharmaceuticals second quarter twenty twenty five earnings conference call today, during which we will review our financial results as well as provide a general business update. Joining me from Fenics 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. Speaker 100:01:07Reference 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. Speaker 100:01:41This conference call is being recorded for audio rebroadcast on Fenics website, www.fennecpharma.com, where it will be available for the next thirty days. And with that, I will now turn the call over to Jeff Hackman. Speaker 200:02:01Thanks, Robert. Good morning, everyone. Thanks for joining the call today. Well, it's hard to believe it's been one year since I stepped in into the CEO role here at Fenwick. When I joined, my focus was clear. Speaker 200:02:15I 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 twelve months, we've been delivering on these priorities, while also driving the awareness and adoption of Pedmark 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 PetMark, which remember still remains the first and only FDA approved therapy in The U. Speaker 200:03:00S. And Europe to reduce the risk of CIO or permanent hearing loss associated with Cisplatin treatment. Headmark 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 2A recommendation for The U. S. For use in adolescent and young adult patients. Speaker 200:03:31But 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, an early validation of our targeted sales approach and enhanced patient support services. Speaker 200:04:19And 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 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 Pedmark and adoption in the community settings. Speaker 200:04:57Second, we are actively working to cement Pedmark 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 PedMark continues to strengthen our confidence in our clinical value and support broader institutional adoption. I'm pleased to also share today that ENCOTA recently issued a positive quality intervention or PQI for Pedmark. Speaker 200:05:42This is an important development that provides peer reviewed practical guidance to oncology care teams on the use administration and timing of Pedmark to prevent CIO in pediatric and AYA or adolescent young adult patients. Encoder 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 in 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 PEDmark as the standard of care in this space. Third, we are expanding our CIO and we are expanding and educating on CIO and an important role of Pedmark, in preventing it, not just, with oncologists, but beyond. Speaker 200:06:43Many healthcare professionals are involved in the patient journey, including ENTs, audiologists, nurses and pharmacists. These groups are now engaging with FENIC and PEDmark, 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. Speaker 200:07:20Our 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 Phenic Hears patient assistance program has been central to this work. We've seen quarter over quarter growth in enrollment in KEAR's programs and the newly revamped offerings that we're delivering, which are giving improved experiences through strengthened health care provider practices, patient services, expanded payer reimbursement support and streamlined access to home nursing resources. And finally, 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. Speaker 200:08:28These 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 are excited to announce that Fenics senior leadership team and employees along with several Pedmark patients and their families will ring the closing bell of the NASDAQ stock market on Friday, 09/05/2025. While this is an exciting business milestone for FENIC, it's important 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 twenty twenty five results. Revenue grew 33% year over year and 10% sequentially with net revenues of 9,700,000.0 This kind of quarter over quarter growth just doesn't happen by chance. Speaker 200:09:25It 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 Pedmark 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 Pedmark. I'm incredibly proud of the FENIC 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 Pedmark across these key markets. Speaker 200:10:18With that, I'll now turn it back over to Robert. Thank you, Jeff. Speaker 100:10:24Really 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 was significant with proper execution ahead of us. Further, I'd like to give much appreciation and recognition to our new leadership team that Jeff brought into FENIC 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 initiatives. Speaker 100:11:11Terri Evans, our Chief Commercial Officer, who has primed our commercial team for optimal excellence. And Pierre Saias, 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 on to the details. Our press release contains some of our financial results for the 2025, which can be viewed on the Investors and Media section of our website. Speaker 100:11:50Rather than read through all those details, my comments today will focus on some key financial results. As Jeff outlined, for the 2025, company recorded net product sales of 9,700,000.0 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 Senec. 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. Speaker 100:12:47As 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 2025. When all the foundational pillars and initiatives we have implemented and continue to optimize are expected to materially impact growth of Edmark. 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 Norgeme in The EU is well underway in The United Kingdom and Germany, and we are pleased with the traction to date. Speaker 100:13:41We expect to provide additional updates on milestones and royalties from this partnership with Norgeen in the quarters to come. Turning to our expenses. Our total cash operating expenses for the quarter exclude non cash stock based compensation, was approximately $11,000,000 This represents an increase of roughly $2,000,000 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 2025. Speaker 100:14:46The company recorded $4,400,000 in selling and marketing expenses in the 2025 compared to $2,900,000 in the 2025 and $4,700,000 in the 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 twenty twenty five. On the G and A front, the company recorded $7,000,000 in the 2025 compared to $6,100,000 in the earlier 2025 and $6,900,000 in the 2024. For the 2025, G and 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 $4,000,000 in cash. Speaker 100:15:56Cash and cash equivalents were approximately $18,700,000 as of 06/30/2025. We remain confident that full year cash operating expenses will be similar in 2025 to that of 2024 or roughly $33,000,000 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 2025. Product revenues continued 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 Norgeme partnership and three, the possible monetization for partnership after the release of the Japan study results, which are expected in the fourth quarter. Speaker 100:17:03And operator, with that, we will now open up the call for questions. Thank Operator00:17:24Our first question comes from the line of Chase Knickerbocker with Craig Hallum. Your line is now open. Speaker 300:17:30Good morning. Thanks for taking Speaker 100:17:32the questions. Jeff, maybe just to start, can would you guys be willing to Speaker 300:17:36share an active prescribers number, particularly obviously within AYA? It would be helpful to see kind of the number of active prescribers you have within that kind of cohort. Speaker 200:17:55Yes. Hi, Chase. How are you? Good morning. We don't share the number, the cumulative number, obviously, for a bunch of different reasons on that guidance. Speaker 200:18:08Tell me a little bit more about what you're maybe a little bit more detail though, and I can maybe share some other specifics, if what you're looking for. Speaker 300:18:18Just an active number of current writers basically. I mean, shared kind of double digit accounts increase sequentially. Mean, maybe on that front, kind of 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. Yes. Speaker 200:18:41Let me go back and look at that. It might be something that we might be able to share in the future quarters, Chase. I don't see that I want to be careful, especially when you start you know, getting a little bit more detail, right, on actual accounts that are out there. And obviously, you have to protect that relationship. But but obviously, doing something with with some numbers might not be you know, it could be something we could do in the future. Speaker 200:19:07So Speaker 300:19:08maybe if we just focus on that double digit accounts 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 200:19:30Yes. I mean, we talked about in the AYA market, it's 10 times the size of the pediatric. It's about 20,000 patients in that population between ages 15 to 39 that are treated with Cisplatin. And so that population is significant. That's our market. Speaker 200:19:50That's where we've divided up the country into our commercial teams and supplied them with that data. Speaker 100:20:01Yeah. And Chase, I'll add, which is important though. 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 been able 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. Speaker 100:20:34So 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 300:20:50Maybe just a little bit 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 200:21:06Yes, 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 as we needed to have that initial patient in that center or that practice go through, know, PetMar therapy, see the positive outcome, see that it works, how they administer it, in some cases actually using our Fenocears program. And now we 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 300:22:07Got it. Maybe just last for me guys. Sorry to get so many in here. But on the EU side, could you share the amount of royalty revenue that was in the quarter from Norgeen? 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? Speaker 300:22:28And then on the 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 100:22:38Yes. Thanks, Chase. To step back a little, as you're aware, the Norgene partnership has two primary components. The first component is are the royalties, and that is a percent, starts in the mid teens of Norgene sales. And the second component is north of 200,000,000 potential milestones. Speaker 100:23:04We 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 work to get the different P and 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 and traction, is significant. Speaker 100:23:43They plan to then roll that out to the broader EU five, later this year, early next year. So you're you're talking Italy, Spain, France, and also to the Nordic regions. So 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. Speaker 100:24:10And we look forward to giving updates on that in the quarters to come. Speaker 300:24:16Thanks guys. Operator00:24:18Thank you. Our next question comes from the line of Sudan Loganathan with Stephens. Your line is now open. Speaker 400:24:26Hi, 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 200:24:47Yes. Initially, when we started, we jumped out to mostly new customers, right? So we saw I mean, if 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. Speaker 200:25:22And so we will see we're we 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 PetSmart. So I think we'll continue to see this new account additions. Speaker 200:25:52But as we grow our business and get bigger, we'll start you'll add those additional accounts behind those that are repeat customers. So at this point, it's, 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 400:26:16Great. I appreciate that color. Second one I wanted to ask here is, with the trial results in Japan expected this fall, could you elaborate on the Japanese market opportunity? For example, the prevalence of CIO in both pediatric and AYA population? 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 200:26:42Right. 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, it's really making sure we understand and get all the data. We are working with the our investigators as well as with some consultants to kind of start to look at, okay, what's our approach? Speaker 200:27:14What is our regulatory approach? And how fast do we want to get this product submitted? As you know, in Japan, you'll need a partner to submit it to the PDMA. And so we're doing we're looking at that approach of that partner strategy in parallel. We're in we've said this before, we're in discussions with folks. Speaker 200:27:35And that's an ongoing process as we move forward. Japan is about a third of the size of The U. S. And Europe when you look at CIO usage. And so that kind of gives you a feel for numbers. Speaker 200:27:56Remember, this will be a probably a pediatric indication in Japan. We had 10 centers that were that participated in the trial. A 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. Speaker 200:28:26We'll probably have more updates in September as we see some of the final data and then 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. The faster we can get this into the Japanese regulatory authorities, the better. Speaker 100:29:01Yes. 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 it's a known product. It's known to work. The reimbursement system is is quite sophisticated. Speaker 100:29:25Having been through the Norgene process a year ago, I think it's it's quite analogous to it. So we look forward to giving more updates. Speaker 400:29:35Great 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 in what areas do you expect will represent maybe your larger expenditures in the upcoming quarters and may drive those expenditures? I know you mentioned, obviously, some of the IP, expense needed for the EU, in the second quarter. Speaker 400:29:55And I was 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 100:30:03Yes. Thank you. So the first half of the year is heavier from a cash OpEx. A lot of our contracts are structured with 50% upfront and then the back in the balance over the back half of the year. So I I as as mentioned in the in the stated remarks, I expect both our second half expenses to go down. Speaker 100:30:27So from a cash operating expenses, we are roughly 20,000,000 for the first half, so I expect it to go down. And the full year to be consistent with '24 from a cash OpEx, which was roughly 33,000,000 to 34,000,000. In the second quarter, specifically, on a noncash 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 400:31:01Great. Thanks. I really appreciate all the insight here. Again, congrats on the second quarter. Operator00:31:08Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is now open. Speaker 500:31:16Hi, 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 200:31:31Sure. Hey, Chad. How are you? Nice to nice to hear from you. Yeah, they differ. Speaker 200:31:40Let me say ENCOTA PQIs are a peer reviewed guidance document, really. And it really is a guidance document to really help patient care and oncology practices. So it's a little bit different because it comes from ENCOTA stands for the National Community Oncology Dispensing Association. So these are kind of these are standardized evidence based kind of practice management type of recommendations. So they're a little bit more focused than the NCCN guidelines, right? Speaker 200:32:19And 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 a PQI for Pedmark. They have now that's access people can have information about our products really without us having to be there. Speaker 200:33:08Can access that information through these PQIs. So we're very excited about it. Speaker 500:33:17Thanks. That was helpful. And then also, could you just talk about how you're splitting marketing resources between the larger AYA opportunity and earlier pediatric population? Are you laser focused on driving Or is there some balance you're targeting there? Speaker 200:33:38Yes, the balance between the two markets. I mean, Wilson, 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 PedMark in these pediatric settings. And so we still continue to get used there. Speaker 200:34:12We still continue to see growth. We don't see the growth that we see in AYA, of course, because during 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 ped and AYA commercial marketability. Speaker 100:34:34Yes. 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 500:35:06Okay, great. Thanks guys. That's all for me. Congrats again. Operator00:35:10Thanks. Yes, thanks. Our next question comes from the line of Ram Selvaraju with H. C. Wainwright. Operator00:35:16Your line is now open. Speaker 600:35:19Hi, good morning. This is Eduardo on for Ram. 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 200:35:41I missed the beginning of that. I'm sorry, Eduardo. Can you repeat that again? Sorry. Speaker 600:35:48Sure. No problem. Just how proactive the FDA has been in ensuring the market is complying with its guidance, not to substitute ped mark with compounded versions of STS? Speaker 200:36:02Well, know, we've had a you know, in the past, we've had the FDA, put out a statement. I think that statement is clear. We, that statement is part of what we continue to utilize when we see that compounding happening. They are the FDA has been supportive of the use of FDA approved product or Pedmark in this situation. So I mean, it continues Eduardo to be probably the one of the bigger areas in the pediatric discussion when we are looking at especially opening up new institutions, we want to make sure and we talk about it all the time about that there is a we're the only FDA approved product that's on the market. Speaker 200:36:51I think it's important to realize in the AYA space, unlike the pediatric space is that the reimbursement and the usage 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 for in the pediatric space. But we continue to utilize, that message from the FDA and continue to have support from them. Eduardo, Speaker 100:37:26when I mentioned briefly, you know, our medical team, they have really reinvigorated both the fact that Penmark is the first and only approved product for the prevention of hearing loss as it relates to cisplatin. Also, understanding very well why cisplatin causes this hearing loss, what the uniqueness is of Penmark. And we started to see though 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 600:38:13Got it. That's that's really helpful. And then, going back to the EU, I think you mentioned, the timeline for expanding. You mentioned you started with, Neurogene had started the work and found some good traction within The UK markets. Could you, repeat the the timeline for when you expect them to launch? Speaker 600:38:32And you mentioned Italy, I think, and a few other countries. But, yeah, just a little bit more clarity on that timeline again. Speaker 100:38:38Sure. So as a reminder, Norgeen has the right to all of the EU, Australia and New Zealand. 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. Speaker 100:39:01The 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. In summary, they're just getting going. They're just getting started, which we're very, very excited about. Speaker 200:39:34Yeah. We're encouraged about the positive indications that we've seen in the early engagement. So Speaker 600:39:40Got it. And do you have any visibility to the Germany pricing that would trigger a milestone payment? Is that correct? Speaker 100:39:46That 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, you know, just a year ago. And so if we were consistent with that in Germany, we look forward to giving additional updates on that milestone. Speaker 600:40:14Got it. Thanks for answering the question. Congrats on the quarter. Operator00:40:18Thank you. 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 200:40:29Well, thank you. Thanks for your questions, everybody. I appreciate it and the continued engagement. As you heard today, we are so pleased with the momentum that we've been able to build in the 2025. This 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. Speaker 200:40:55We remain focused on the disciplined execution that we've talked about today, the strategic imperatives, and we're confident on the path ahead. So, 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 you more on our continued progress in the quarters to come. Speaker 200:41:25And thank you for participating today. Operator00:41:29This concludes today's conference call. Thank you for your participation. You may now disconnect.Read morePowered by