Earnings call transcript: Fennec Pharmaceuticals Q2 2025 results disappoint

Fennec Pharmaceuticals reported a disappointing second quarter of 2025, with an earnings per share (EPS) of -$0.11, missing the forecasted -$0.04 by a significant margin. Despite a revenue surprise of 2.77% above expectations, reaching $9.65 million, the market reacted negatively. In premarket trading, Fennec’s stock dropped by 17.67%, reflecting investor concerns over the earnings miss.

Key Takeaways

• Fennec Pharmaceuticals missed EPS expectations significantly.
• Revenue growth was strong, with a 33% year-over-year increase.
• Stock price fell sharply in premarket trading, down 17.67%.
• The company remains optimistic about future growth in the latter half of 2025.
• Pedmark continues to gain traction in the market.

Company Performance

Fennec Pharmaceuticals, with a market capitalization of $251.61 million, demonstrated robust revenue growth in Q2 2025, with a 33% increase year-over-year and a 10% sequential rise from the previous quarter. This marks the third consecutive quarter of sequential growth. While the significant miss on EPS indicates challenges in managing costs or achieving expected profitability levels, analysts maintain optimistic price targets ranging from $13 to $15 per share.

Financial Highlights

• Revenue: $9.65 million, up 33% year-over-year
• Earnings per share: -$0.11, missing forecast by $0.07
• Cash and cash equivalents: $18.7 million as of June 30, 2025
• Total cash operating expenses: Approximately $11 million

Earnings vs. Forecast

Fennec’s EPS of -$0.11 was a substantial miss compared to the forecast of -$0.04, resulting in a negative surprise of 175%. This divergence from expectations raises concerns about the company’s cost management and operational efficiency. However, revenue exceeded forecasts by 2.77%, indicating strong sales performance.

Market Reaction

Following the earnings release, Fennec’s stock price dropped by 17.67% in premarket trading, falling to $7.50. This decline reflects investor disappointment with the earnings miss, despite the positive revenue surprise. Based on InvestingPro’s Fair Value analysis, the stock appears undervalued at current levels. The stock’s performance is now closer to its 52-week low of $3.96, a significant drop from its recent highs.

Outlook & Guidance

Fennec Pharmaceuticals anticipates substantial growth in the latter half of 2025, targeting cash profitability and leveraging potential milestones from their Norgene partnership. The company is also preparing for trial results in Japan by Q4 2025, which could open new market opportunities. InvestingPro’s comprehensive analysis indicates a "GOOD" overall financial health score, suggesting strong fundamentals despite current challenges. Subscribers can access the detailed Pro Research Report, part of the coverage of over 1,400 US stocks, for deeper insights into Fennec’s growth potential.

Executive Commentary

CEO Jeff Hackman emphasized the company’s growth trajectory, stating, "We are now talking about three consecutive quarters of growth and more to come." CFO Robert Andrade highlighted the strong customer retention and new demand for Pedmark, indicating a positive market response to their flagship product.

Risks and Challenges

• Managing operating expenses to improve profitability
• Potential competition in the pediatric and AYA CIO markets
• Regulatory hurdles in new market entries, such as Japan
• Dependence on successful execution of strategic partnerships

Q&A

During the earnings call, analysts inquired about the company’s strategy for expanding its market presence, particularly in Europe with the Norgene partnership. Executives also addressed concerns about the FDA’s guidance on product substitution and detailed their approach to capturing both pediatric and AYA segments.

Full transcript - Fennec Pharmaceuticals Inc (FENC) Q2 2025:

Conference Operator: Good 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.

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: Thank 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.

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 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.

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: Thanks, 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.

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 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.

S. 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.

But before we dive into the performance for the quarter, let me update you on significant progress that we’ve made during the first half of this year. First, we’ve made significant strides in increasing awareness of the unmet need among both oncology and broader cancer care communities. We’ve done this through continued presence at major conferences, targeted educational campaigns and peer to peer interactions. We’re seeing growing recognition that hearing loss from Cisplatin is not just a side effect, it’s preventable and it’s an issue with long term consequences. We’re seeing the strongest momentum in both large community practices and academic centers, an 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 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 ENCOTA 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 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.

Many 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.

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 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.

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 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.

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 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.

With that, I’ll now turn it back over to Robert. Thank you, Jeff.

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: 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 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.

Terri 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.

Rather 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.

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 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.

We 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.

The 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.

Cash 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.

And operator, with that, we will now open up the call for questions. Thank

Conference Operator: Our first question comes from the line of Chase Knickerbocker with Craig Hallum. Your line is now open.

Chase Knickerbocker, Analyst, Craig Hallum: Good morning. Thanks for taking

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: the questions. Jeff, maybe just to start, can would you guys be willing to

Chase Knickerbocker, Analyst, Craig Hallum: share 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.

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: Yes. 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.

Tell 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.

Chase Knickerbocker, Analyst, Craig Hallum: Just 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.

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: 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 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.

So

Chase Knickerbocker, Analyst, Craig Hallum: 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, kind of what your kind of overall opportunity is maybe just in those accounts that have kind of added on sequentially?

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: Yes. 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.

That’s where we’ve divided up the country into our commercial teams and supplied them with that data.

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: Yeah. 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.

So I think where we wanted to shed light was we had 14 new accounts. Don’t get focused on the amount of accounts because each account is unique, but we are growing. And the goal is obviously then to build that existing base and augment that as well.

Chase Knickerbocker, Analyst, Craig Hallum: 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 said account?

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: 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 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.

Chase Knickerbocker, Analyst, Craig Hallum: 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 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?

And 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.

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: Yes. 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.

We started to see some significant traction, in the second quarter from that partnership. As a reminder, they launched late in the first quarter. The second quarter, we started to see some traction really out of The UK as they 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.

They 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.

And we look forward to giving updates on that in the quarters to come.

Chase Knickerbocker, Analyst, Craig Hallum: Thanks guys.

Conference Operator: Thank you. Our next question comes from the line of Sudan Loganathan with Stephens. Your line is now open.

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

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: 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’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.

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.

Sudan Loganathan, Analyst, Stephens: Great. 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.

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: Right. So we’re in the final discussions of trying to understand all the data. We’ll have some meetings in September here with the investigators to really kind of go through all the data tables and get ourselves familiar with that. So that’s the first part is, 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 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.

And 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.

Remember, 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.

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. The faster we can get this into the Japanese regulatory authorities, the better.

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: Yes. 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.

Having 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.

Sudan Loganathan, Analyst, Stephens: Great to hear. Just lastly, if I can squeeze one more in. Do you anticipate the operating expenses to remain relatively stable in the second half of the year? And 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.

And 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?

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: 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 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.

So 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.

Sudan Loganathan, Analyst, Stephens: Great. Thanks. I really appreciate all the insight here. Again, congrats on the second quarter.

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

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

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: Sure. Hey, Chad. How are you? Nice to nice to hear from you. Yeah, they differ.

Let 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?

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 products really without us having to be there.

Can access that information through these PQIs. So we’re very excited about it.

Chad, Analyst, Maxim Group: Thanks. 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?

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: Yes, 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.

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.

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: 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.

Chad, Analyst, Maxim Group: Okay, great. Thanks guys. That’s all for me. Congrats again.

Conference Operator: Thanks. Yes, thanks. Our next question comes from the line of Ram Selvaraju with H. C. Wainwright.

Your line is now open.

Eduardo, Analyst, H.C. Wainwright: Hi, 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?

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: I missed the beginning of that. I’m sorry, Eduardo. Can you repeat that again? Sorry.

Eduardo, Analyst, H.C. Wainwright: Sure. No problem. Just how proactive the FDA has been in ensuring the market is complying with its guidance, not to substitute ped mark with compounded versions of STS?

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: Well, 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.

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. Eduardo,

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: when 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.

Eduardo, Analyst, H.C. Wainwright: Got 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?

And you mentioned Italy, I think, and a few other countries. But, yeah, just a little bit more clarity on that timeline again.

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: Sure. 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.

The additional, as they call the EU5 markets on top of Germany, UK, where you have Italy, Spain and France, We expect, a launch early next year with preparation later this year. And the Nordic countries, Denmark, Norway, and additionally, Switzerland starting to come on later this year and early next year. In summary, they’re just getting going. They’re just getting started, which we’re very, very excited about.

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: Yeah. We’re encouraged about the positive indications that we’ve seen in the early engagement. So

Eduardo, Analyst, H.C. Wainwright: Got it. And do you have any visibility to the Germany pricing that would trigger a milestone payment? Is that correct?

Robert Andrade, Chief Financial Officer, Fenics Pharmaceuticals: That is a material milestone. We look forward to providing additional updates. What we do have is we have, final pricing in The UK, which well exceeded, what we were anticipating, 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.

Eduardo, Analyst, H.C. Wainwright: Got it. Thanks for answering the question. Congrats on the quarter.

Conference Operator: Thank 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.

Jeff Hackman, Chief Executive Officer, Fenics Pharmaceuticals: 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 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.

Conference Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.