Good morning, ladies and gentlemen, and welcome to Fennec 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 Fennec's Chief Financial Officer, Robert Andrade. 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. Reference 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. With that, I will now turn the call over to Jeff Hackman. Hey, thanks, Robert. Good morning, everyone. Thanks for joining the call today. It's hard to believe it's been one year since I stepped 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 PEDMARK for the prevention of cisplatin-induced ototoxicity, or CIO. 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 Fennec last year, I outlined a focused set of strategic imperatives to drive our execution and accelerate the long-term growth of PEDMARK, 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. PEDMARK 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 the U.S. for use in adolescent and young adult patients. 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. 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 PEDMARK and adoption in the community settings. Second, 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 NCODA recently issued a Positive Quality Intervention, or PQI, for PEDMARK. This 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 and young adult, patients. NCODA PQIs are widely used tools that support multidisciplinary cancer teams, including pharmacists, nurses, and oncologists, in delivering high-quality care for patients receiving oral and IV therapies in oncology. Most importantly, we see PQI as a strong signal of growing clinical alignment around the 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 and educating on CIO and the important role of PEDMARK in preventing it, not just with oncologists, but beyond. Many healthcare professionals are involved in the patient journey, including ENTs, audiologists, nurses, and pharmacists. These groups are now engaging with Fennec and PEDMARK, and we're seeing the benefit of this multidisciplinary support in day-to-day clinical practices. We are reminded in the expansion that the care of these oncology patients, especially when it comes to survivorship and quality of life, 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 HEARS patient assistance program has been central to this work. We've seen quarter-over-quarter growth in enrollment in Fennec HEARS 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. 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 are excited to announce that Fennec's 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, September 5, 2025. While this is an exciting business milestone for Fennec, 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 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 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 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 PEDMARK across these key markets. With that, I'll now turn it back over to Robert. Thank you, Jeff. 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. Further, 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 Cioppi, our Chief Strategy Officer and leader in many areas, including our awareness and marketing initiatives; 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 have 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 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 the growth of PEDMARK. 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 PEDMARQSI by Norgine 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 Norgine in the quarters to come. Turning to our expenses, our total cash operating expenses for the quarter, excluding non-cash stock-based compensation, were 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 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 30, 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 free 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 Norgine partnership, and three, the possible monetization or partnership after the release of the Japan study results, which are expected in the fourth quarter. Operator, with that, we will now open up the call for questions. Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Chase Knickerbocker with Craig-Hallum. Your line is now open. 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 cohort. Yeah. 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 of, and I can maybe share some other specifics if you what you're looking for. Just an active number of current writers, basically. I mean, you've shared kind of double-digit accounts increase sequentially. I mean, maybe on that front, if you'd be willing to share kind of an active account number just as we can so we can think about the ramp from here in AYA. Let me go back and look at that. It might be something that we might be able to share in future quarters, Chase. I want to be careful, especially when you start getting a little bit more detail on actual accounts that are out there. Obviously, you have to protect that relationship. Obviously, doing something with some numbers might not be, it could be something we could do in the future. Yeah, maybe if we just focus on that double-digit accounts sequentially, Jeff. Can you give us some kind of visibility into maybe how many patients within those accounts in AYA are treated with cisplatin and what your overall opportunity is, maybe just in those accounts that have added on sequentially? Yeah, I mean, we talked about, you know, in the AYA market, it's 10x the size of the pediatric. It's about 20,000 patients in that population between, you know, ages 15 - 39 that are treated with cisplatin. That population is significant. That's, you know, that's our market. That's where, you know, we've divided up the country into our, you know, commercial teams and supplied them with that data. Yeah, and Chase, I'll add, which is important to know, 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. 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. I think where we wanted to shed light was, you know, we had 14 new accounts. Don't get focused on the amount of accounts because each account is unique, but we are growing. The goal is obviously then to build that existing base and augment that as well. Maybe just a little bit of additional color on that. You know, 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? Yeah, we see it. We saw it more in the second quarter as we started to get experience, Chase. That's exactly where, you know, where Robert was going is we needed to have that initial patient in that center or that practice go through PEDMARK therapy, see the positive outcome, see that it works, how they administer it, in some cases actually using our Fennec HEARS program. Now, that's the area where obviously a lot of our folks will focus their efforts to expand in those same practices because remember, these physicians and these oncology practices have multiple cisplatin patients that they're going through. That's where we saw a lot of our growth was through expansion of current accounts in Q2. We'll see even more of that as we go through the year. Got it. Maybe just last for me, guys, sorry to get so many in here. On the EU side, could you share the amount of royalty revenue that was in the quarter from Norgine? Just kind of general thoughts on how that ramp is going with your partner, particularly as we go into the back half of the year here. On kind of final German pricing, do you have a thought on when we should hear back on that? Thanks for taking the questions. Yeah, thanks, Chase. To step back a little, as you're aware, the Norgine partnership has two primary components. The first component are the royalties, and that is a percent. It starts in the mid-teens of Norgine sales. 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. In the second quarter, we started to see some traction really out of the UK as they work 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 on an aggregate basis, but the sequential increase in traction is significant. They plan to roll that out to the broader EU five later this year, early next year. You're talking Italy, Spain, France, and also to the Nordics. 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. We look forward to giving updates on that in the quarters to come. Thanks, guys. Thank you. Our next question comes from the line of Sudan Loganathan with Stephens. Your line is now open. Hi, good morning. Congrats on the progress in the second quarter, and thank you for taking my question. My first one, I wanted to just get some color on the mix of new and repeat customers. Maybe you can provide a% amount of either to kind of get a look at the potential net penetration and how that's progressing. Yeah, initially, when we started, we jumped out to mostly new customers, right? We saw, you know, 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. We will see, you know, 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, you know, growing these new accounts, and it's really critical for us because there are so many accounts out there not touching PEDMARK. I think we'll continue to see these new account additions, but as we grow our business and get bigger, we'll start to 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. Great. I appreciate that color. 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 salesforce you may implement there in that region. Right. We're in the final discussions of trying to understand all the data. We'll have some meetings in September with the investigators to really go through all the data tables and get ourselves familiar with that. 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 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. 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. That 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. We've had some really good feedback from the folks in-country. 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? The faster we can get this into the Japanese regulatory authorities, the better. 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 Norgine process a year ago, I think it's quite analogous to it. We look forward to giving more updates. 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? 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 expenses needed for the EU in the second quarter. I'm just kind of curious if there's any more maybe one-time expenses in the second half of this year as you're going to launch. Yeah, thank you. 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 balance over the back half of the year. As mentioned in the stated remarks, I expect both our second half expenses to go down. From a cash operating expense, we are roughly $20 million for the first half. I expect it to go down, and the full year to be consistent with $24 million from a cash OpEx, which was roughly $33 million - $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. Great, thanks. I really appreciate all the insight here. Again, congrats on the good things. Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is now open. 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. Sure. Hey, Chad. How are you? Nice to hear from you. Yeah, they differ. Let me say, the NCODA PQIs are a peer-reviewed guidance document, really. It really is a guidance document to really help patient care and oncology practices. It's a little bit different because it comes from NCODA, which stands for the National Community Oncology Dispensing Association. These are kind of standardized, evidence-based, practice management type of recommendations. They're a little bit more focused than the NCCN guidelines, right? The purpose of these PQIs, we call them, is to kind of really focus on patient outcomes and really look at standardizing care, optimizing treatments, and enhancing communications with the oncology teams. 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. We really think that this is an important milestone for us to now have a PQI for PEDMARK. That's access. People can have information about our products, really, without us having to be there. They can access that information through these PQIs. We're very excited about it. Thanks. That was helpful. Could you just 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? 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, you know, when we're in an academic institution, we're there, you know, 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. We still continue to get use there. We still continue to see growth. We don't see the growth that we see in AYA, of course, because, you know, during this launch phase, it's obviously much larger. We instruct our commercial organization as well as our medical organization. When we're in these institutions, we're doing both PED and AYA, you know, commercial marketability. Yeah, 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. Conversely, doors have also opened for pediatric as a result of the progress that we've made with AYA. That's really the beauty of the opportunity. Different size market opportunities, but really growth potential in each one. Okay, great. Thanks, guys. That's all from me. Congrats again. Thanks. Yeah, thanks. Our next question comes from the line of Raghuram Selvaraju with H.C. Wainwright. Your line is now open. 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 PEDMARK with other compounded versions of your API and that formulation? I'm sorry, Eduardo. Can you repeat that again? Sorry. Sure, no problem. Just how proactive the FDA has been in ensuring the market is complying with its guidance not to substitute PEDMARK with compounded versions of STS. We've had the FDA put out a statement. I think that statement is clear. That statement is part of what we continue to utilize when we see that compounding happening. The FDA has been supportive of the use of FDA-approved product or PEDMARK in this situation. It continues, Eduardo, to be probably 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, 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, that the reimbursement and the usage of compounded products are much different in the community settings as well. We don't have as much of an issue there as we do in some of the academic centers in the pediatric space. We continue to utilize that message from the FDA and continue to have support from them. Eduardo, when I mentioned briefly, you know, 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 cisplatin. Also, understanding very well why cisplatin causes this hearing loss, what the uniqueness is of PEDMARK. We've started to see, though, that bear fruit just in recent quarters, and we expect more to come. We've got a lot of enthusiasm, as Jeff mentioned, both in new pediatric patients and also in AYA. In AYA specifically, we have seen no compounded use of the product. Got it. That's really helpful. Going back to the EU, I think you mentioned the timeline for expanding. You mentioned you'd started with Norgine, had started the work, and found some good traction in the UK markets. Could you repeat the timeline for when you expect them to launch? You mentioned Italy, I think, and a few other countries. Just a little bit more clarity on that timeline again. Sure. As a reminder, Norgine has the rights 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. 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 and the UK, where you have Italy, Spain, and France, we expect a launch early next year with preparation later this year. The Nordic countries, Denmark, Norway, and additionally Switzerland, are starting to come on later this year and early next year. Got it. In summary, they're just getting going. They're just getting started, which we're very, very excited about. Yeah, we're encouraged about the positive indications that we've seen in the early engagement. Got it. Do you have any visibility to that Germany pricing? That would trigger a milestone payment, is that correct? 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 exceeded what we were anticipating just a year ago. If we're consistent with that in Germany, we look forward to giving additional updates on that milestone. Got it. Thanks for answering the question. We'll move on from the quarter. Thank you. 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. 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 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, these strategic imperatives, and we're confident on the path ahead. 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. We appreciate your support. We look forward to updating you more on our continued progress in the quarters to come. Thank you for participating today. This concludes today's conference call. Thank you for your participation. You may now disconnect.