FENC - NASDAQ

Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals' Second Quarter 2025 Earnings and Corporate Update Conference Call. [Operator Instructions] 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. And with that, I will now turn the call over to Jeff Hackman.

Thanks, Robert. Good morning, everyone. Thanks for joining the call today. Well, it's hard to believe it's been 1 year since I stepped in into the CEO role here at Fennec. 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. And the results are beginning to materialize. We are now talking about 3 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 1 month of age and older with localized non-metastatic solid tumors and also was 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. But before we dive into the performance for the quarter, let me update you on significant progress that we've made during the first half of this year. First, we made significant strides in increasing awareness of the unmet need among both oncology and broader cancer care communities. We've done this through continued presence at major conferences, targeted educational campaigns and peer-to-peer interactions. We're seeing growing recognition that hearing loss from cisplatin is not just a side effect, it's preventable, and it's an issue with long-term consequences. We're seeing the strongest momentum in both large community practices and academic centers. and early validation of our targeted sales approach and enhanced patient support services. And to that end, I'm pleased to share that a large national oncology group of providers recently added PEDMARK to its formulary for its use in patients under 40 years of age. This is 1 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 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. 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 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 oncologists. 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. And finally, on the activation side, while our near-term commercial focus remains on educating healthcare providers to support a shift in the standard of care, we are also strengthening our efforts to educate and engage patients and caregivers. We are doing this through the support of several advocacy associations or organizations, such as the Testicular Cancer Awareness Foundation and activities surrounding initiatives like the Childhood Cancer Awareness month. These efforts help raise awareness of the risk of CIO and encourage families to inform and have informed conversations about hearing protection during their treatment planning. Further, we 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 2 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 1 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 9 months ago and who have been on the front lines in this execution. Christi Cioffi, 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 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 second quarter of 2025, which can be viewed on the Investors & 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 continued to optimize are expected to materially impact growth of PEDMARK. The strong performance reflects both successful retention of existing customers, and the exciting new uptake in 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, exclude noncash stock-based compensation, was 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 head count 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 '25 compared to $2.9 million in the first quarter of '25 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 onetime accrual reversal that occurred only in Q1 2025. On the G&A front, the company recorded $7 million in the second quarter of 2025 compared to $6.1 million in the earlier quarter, first quarter of '25 million and $6.9 million in the second quarter of '24. 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 noncash 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 '25 to that of '24 or roughly $33 million. This includes an increase in commercial expenses, including higher head count and marketing expenses offset by the elimination of European pre-commercialization costs, which only occurred in 2024. Importantly, we have several levers to potentially increase the cash balance in the second half of 2025. Product revenues continued to gain momentum, and we aim towards cash profitability as cash expenses also decreased 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. And operator, with that, we will now open up the call for questions.

[Operator Instructions] Our first question comes from the line of Chase Knickerbocker with Craig-Hallum.

Jeff, maybe just to start, would you guys be willing to share active -- an prescribers number, particularly obviously within AYA as just it would be helpful to see kind of the number of active prescribers you have within that kind of cohort.

Yes. The -- we don't share the number -- the cumulative number, obviously, for a bunch of different reasons on that guidance. Tell me a little bit more about what your -- maybe a little bit more detail, though, and I can maybe share some other specifics what you're looking for.

Just an active number of current writers basically. I mean you shared kind of double-digit accounts increase sequentially. I 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, yes. Let 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 getting a little bit more detail, right, on actual accounts that are out there. And obviously, you have to protect that relationship. But obviously, doing something with some numbers might not be -- it could be something we could do in the future. So...

Maybe 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 and kind of what your kind of overall opportunity is maybe just in those accounts that have kind of added on sequentially?

Yes. I mean, we talked about in the AYA market, it's 10x 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. That's where we've divided up the country into our commercial teams and supply them with that data.

Yes. And Chase, I'll add, which is important, but it starts generally with 1 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. So I think what 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.

And then maybe 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 set account?

Yes, we see it -- we saw it more in the second quarter as we started to get experience, Chase. That's exactly where Robert was going was we needed to have that initial patient in that center or that practice go through PEDMARK therapy, see the positive outcome, see that it works, how they administer it, in some cases, actually using our Fennec HEARS 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 in 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.

Got 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 Norgine? And then just kind of general thoughts on kind of how that ramp is going with your partner, particularly as we go into the back half of the year here. And then on kind of final German pricing, I mean, do you have a thought on when we should hear back on that?

Yes. Thanks, Chase. To step back a little, as you're aware, the Norgine partnership has 2 primary components. The first component is -- are the royalties, and that is a percent, starts in the mid-teens of Norgine sales. And the second component is north of $200 million potential milestones. We started to see some significant traction in the second quarter from that partnership. As a reminder, they launched late in the first quarter. The second quarter, we started to see some traction really out of the U.K. 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 certainly increase in traction is significant. They plan to then roll that out to the broader EU5 later this year, early next year. You're talking Italy, Spain, France and also to the Nordic regions. So we're quite enthusiastic about that opportunity. Near term, there are 2 primary milestones ahead of us. One is based on aggregate calendar year sales and the other one is just on German pricing and we look forward to giving updates on that in the quarters to come.

Our next question comes from the line of Sudan Loganathan with Stephens.

Congrats on the progress in the second quarter. My first one, I 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?

Yes. 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. And so we will see -- 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 PEDMARK. So I think we'll continue to see this new account additions. But as we grow our business and get bigger, we'll start -- you'll add those additional accounts behind those that are repeat customers. 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.

Great. I appreciate that color. The second one I wanted to ask here, 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?

Right. We -- 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, 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 (sic) [ PMDA ] and so we're doing -- we're looking at that approach and that partner strategy in parallel. We're in -- we've said this before, we're in discussions with folks. And that's an ongoing -- that's an ongoing process as we move forward. Japan is about 1/3 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 the -- for the numbers. Remember, this will be probably a pediatric indication in Japan. We had 10 centers that were -- that participated in the trial. It's 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. We'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, right? So the faster we can get this into the Japanese regulatory authorities, the better.

Yes. 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. So we look forward to giving more updates.

Great to hear. Just lastly, if I can squeeze 1 more in. Do you anticipate the operating expenses to remain relatively stable in the second half of the year? And what areas do you expect will represent maybe your larger expenditures in 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. And just kind of curious if there's any more kind of maybe one-time expenses in the second half of this year as you're growing the launch?

Yes. 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 -- and the balance over the back half of the year. So as mentioned in the stated remarks, I expect both our second half expenses to go down, so from a cash operating expenses, we were roughly $20 million for the first half. So I expect it to go down and the full year to be consistent with '24 from a cash OpEx, which was roughly $33 million to $34 million. 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.

Our next question comes from the line of Jason McCarthy with Maxim Group.

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, Chad. Nice to hear from you. Yes, the -- they differ -- let me -- the NCODA 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 the -- NCODA stands for the National Community Oncology Dispensing Association. So these are kind of -- these are standardized evidence-based kind of practice management type of recommendation. So they're a little bit more focused than the NCCN guidelines, right? And the purpose of these PQIs, we call them, are to kind of really focus on patient outcomes and really look at standardizing care and optimizing treatments and enhancing communications with the oncology teams. And so they're a little bit more focused. They're a little bit below the level of these NCCN guidelines. They cover various aspects, not just cancer care, but also kind of how to select patients or monitoring or counseling or management strategies. And so we really think that this is an important milestone for us to now have a PQI for PEDMARK. They have now -- that's access people can have information about our product really without us having to be there, they can access that information through these PQIs. So we're very excited about it.

That's helpful. And then also, could you just talk about how you're splitting marketing resources between the larger AYA opportunity in earlier pediatric population? Are you laser-focused on driving this newly opened market? Or is there some balance you're targeting there?

Yes. The balance between the 2 markets. I mean, listen, we've said all along that we believe that the opportunity is much larger in AYA, but that we don't especially in the academic institutions, when we're in an academic institution, we're there on the pediatric side as well as the AYA side. Obviously, we know that the size and the market is much different but there's still that incredible need for PEDMARK in these pediatric settings. And so 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 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.

Yes. 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.

Our next question comes from the line of Ram Selvaraju with H.C. Wainwright.

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 PEDMARK with other compounded versions of your AP and that formulation?

I missed the -- I missed the beginning of that, 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 compound versions of STS?

Well, we've had -- 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 1 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. I 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.

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

Got it. That's really helpful. And then going back to the EU, I think you mentioned the time line for expanding. You mentioned you started with Norgine has started the work and found some good traction with in the U.K. markets. Could you repeat the time line for when you expect them to launch and you mentioned Italy, I think, and a few other countries. But yes, just a little bit more clarity on that time line again.

Sure. So as a reminder, Norgine has the rights to all of the EU, Australia and New

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

And do you have any visibility to the Germany pricing that would trigger a milestone payment? Or 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 U.K., which well exceeded what we were anticipating just a year ago. And so if we're consistent with that in Germany, we look forward to giving additional updates on that milestone.

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.

Well, 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. 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. We 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, and thank you for participating today.