Fennec Pharmaceuticals Inc.

and 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 call is being recorded. Now, I would like to turn the conference over to FENIX Chief Financial Officer Robert Andraty.

Thank you, Operator, and good morning, everyone. We appreciate you joining us today for FENIX Pharmaceutical's first quarter 2025 earnings conference call, during which we will review our financial results as well as provide a general business update. Joining me from FENIX 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 only as of today and should not be relied upon as representing our views as of any subsequently. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on FENIX's website .fennixpharma.com, where it will be available for the next 30 days. And with that, I will now turn the call over to Jeff Hackman.

Thank you, Robert. And good morning, everyone. I wanted to thank you all for joining us today as we review our first quarter performance and share the outlook for the year ahead. I'm excited to share the details and highlights of our results for Q1 in 2025. So the alignment of our organization around clear commercial priorities to enhance field execution and support sustainable growth across key PEDMARC segments really began back in Q4 2024. Much of the work was implemented, though, in Q1 of this year. Therefore, Q1 was a quarter marked by a stronger strategic focus, disciplined execution, and a much more meaningful progress across all areas of our business. This was accomplished with really just a few critical activities. Let me go into those. The first is the development and implementation of a targeting model, a much more sophisticated model than the organization had in the past. It was data driven and prescriber and practice list to guide field execution and engagement were used. This was a critical step to better understand our business and our opportunities, especially given our expansion beyond pediatrics into the adolescent and young adult or AYA patient population. This targeting includes a structured tiering of Cisflatin prescribers nationally, prioritizing tiers like tier one through five, or those who treat high number of patients with Cisflatin, allowing us to focus on engagement in key academic institutions and large community practices where PedMark can have the greatest clinical and commercial impact. As a result, the first quarter tier one targets prescribed for PedMark demonstrated early traction and validation of our focused engagement strategy. Some of the examples of these accounts are Tampa General Hospital in Florida, Rady's Children's in San Diego, Huntsman's Cancer in Salt Lake, Zuni Comprehensive Health Center in New Mexico, and City of Hope, which is one of the largest advanced cancer centers in the country. These are just some accounts and others that have begun to integrate PedMark into their treatment plans, further validating its clinical utility and expanding patient access in real world settings. As a part of these efforts, we continue to be encouraged by the interest and adoption we see in the AYA segment. We've mentioned on prior calls that this opportunity for the segment is very significant in the U.S. FENIC estimates that approximately 20,000 Cisflatin chemotherapy patients are treated annually in the primary types, tumor types, thyroid cancer, breast cancer, germ cell, and testicular. The market potential in AYA is greater than the size of the pediatric market and has a favorable reimbursement profile via outpatient reimbursement. We also made significant strides on the medical front, increasing positive engagements with key opinion leaders and building momentum around awareness of the impact of Cisflatin-induced ototoxicity. Our medical team also strengthened their clinical messaging based upon the data and interactions and new medical science liaisons or MSLs that joined our team and are already engaging with national KOLs. As an example of our cross-functional alignment in late April, FENIC and our teams had an advisory board comprised of key opinion leaders from across the nation with specialties in medical oncology, urologic surgery, directors of pharmacy. This discussion focused on AYA treatment paths within academic institutions in these large community practices. During this meeting, FENIC's team gathered additional market insights to further inform and refine our executional excellence moving forward. We're also actively working to further enhance our FENIC HEARES patient support program to ensure a more seamless, supportive experience for both providers and patients at every step of the PEDMARC journey. These upgrades designed to improve access, dreamline reimbursement, and expand home nursing capabilities. FENIC HEARES is critical for the healthcare provider's adoption and patient adherence. We experienced improvement in patient adherence throughout the quarter and we expect this to continue throughout the year as we bolster and support our offerings both with the HCPs and patients that we serve. By removing some of these friction points and delivering a very high-touch experience across the treatment journey, we're not only supporting better care but we're also helping to empower providers to identify and treat more eligible patients. This is essential and critical given the growing recognition of hearing loss, which is an essential part of cancer survivorship. As awareness increases, our program ensures providers are equipped with the right tools and support to proactively engage patients who may benefit from PEDMARC intervention, helping us to advance both clinical access and also outcomes to care. Now I'd like to also address the commercial launch efforts and the progress that we're making at PEDMARC outside the US. Following our exclusive licensing agreement that FENIC executed back in March 2024 with Norgene Pharmaceuticals, the product has now launched commercially in Germany and in the UK. And just this past week, Norgene announced that the Scottish Medicine Consortium or SMC has accepted PEDMARC for use in Scotland. Collectively, these recent launches mark important steps in achieving FENIC's mission of expanding access to PEDMARC and PEDMARC-C to cancer patients at risk of hearing loss in the European Union and the UK. Also on the global front, the investigator-initiated trial in Japan, or SDSJ01, evaluating PEDMARC was fully now enrolled as of October 2024. The clinical trial, SDSJ01, evaluates the efficacy and safety of PEDMARC in reducing auto toxicity induced by splatting children and AYA's would localize solid tumors. The primary endpoint of this trial is to assess the frequency of hearing impairment at the end of treatment. Results of the trial are expected in the second half of 2025 with potential evaluation of both the registration and partnering or

licensing

of PEDMARC in Japan thereafter. Looking ahead, we are building a solid foundation with a laser-focused vision, as I mentioned, as we entered into 2025. This includes deepening our relationships with our key accounts, expanding adoption with new existing customers, and seeking evidence-based data generation through investigator-sponsored trials, or we call them ISTs. Based on our sharpened messaging, our strategic focus, and this discipline execution in the first quarter, we made some meaningful progress across all areas of our business. We're seeing positive momentum in our strategy to move healthcare providers from trial to adoption of PEDMARC. The strong momentum has continued in early Q2, and I look forward to continued progress and sharing those results with you throughout the year. With that, I'll turn it back over to Robert.

Thank you, Jeff. Our press release contains details of our financial results for the first 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. For the first quarter of 2025, the company recorded net product sales of approximately 8.8 million compared to 7.4 million in the first quarter of 2024. This reflects 18% growth compared to the same period last year and an 11% increase over the fourth quarter of 2024. Of significance, we are pleased to report our second consecutive quarter of growth and net product sales. As mentioned in March 2025, we are focusing on growing net product sales and anticipate the most significant quarterly growth in the second half of 2025, when all the foundational pillars and initiatives we are putting in place are expected to materially impact the growth of PEDMARC. The company recorded 2.9 million in selling and marketing expenses in the first quarter of 2025 compared to 3.9 million in the fourth quarter of 2024 and 5.2 million in the first quarter of 2024. The decrease on a -over-year basis is primarily attributable to the elimination of expenses associated with European pre-commercialization activities, which occurred in 2024. Prior to the announcement of the Norgen partnership, to be clear and as stated previously, European pre-commercialization expenses are not expected in 2025. The company recorded 6.1 million in GNA expenses in the first quarter of 2025 compared to 4.1 million in the fourth quarter of 2024 and 5.9 million in the comparable quarter of 2024. For the first quarter of 2025, GNA expenses were consistent on a -over-year basis and increased -over-quarter, largely due to -cash-based stock compensation traditionally done in the first fiscal quarter. The cash and cash equivalents were $22.6 million as of March 31, 2025. The company burned approximately $4 million in cash in the first quarter of 2025. As stated in our March 2025 call, we remain confident in the full-year cash operating expenses to be similar in 2025 to 2024, or approximately $33 million. This includes a step up in marketing expenses and increased headcount offset by the elimination of European pre-commercialization expenses. 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 and fiscal year spending patterns. Before concluding, I'd like to offer some initial perspective on the recent discussions regarding potential tariffs. As you may know, TedMark is manufactured in the United States, and as such, we don't anticipate that currently proposed tariffs will have a material impact on our gross margins for overall financial performance. Operator, with that, we will now open up the call for questions.

To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. In the interest of time, we ask that you please lend yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question comes from Chase Knickerbocker with Craig Howell. Your line is open.

Good morning. Thanks for the questions. Just a couple kind of metrics that I think would be helpful on the AYA side first. Now that you've got a little bit more experience in that segment of the market, can you cue us in on what the average number of vials per patient per full treatment has been and how that's compared to your expectations and then what percentage of patients are making it through that full course and maybe how that has improved and how that's informed your patient support program?

Sure. Hey, Chase, how are you? Thanks for the question. Yeah, we are seeing on average about 30 vials per patient in the AYA space. That can range, obviously, but on average about 30. Again, you know this is a kind of a weight-based dosing regimen, so it depends on the size, as you can imagine. We're seeing, and one of the things that we're improving on is our adherence numbers, and we're seeing that that ranges around 50% of the patients are getting through full dose or full adherence. And so kind of some of the focus that I had mentioned was about getting Fennec-Hiers in the right place. Fennec-Hiers was kind of designed for pediatric use in large institutions, but as this product now gets moved out into the community setting and a little bit more of the -in-home administration, adherence is really critical for the product, and that's why we needed to really focus our efforts on kind of revamping Fennec-Hiers and making sure that we increase those adherence numbers as high as we can get them. And we'll see that increase as we move throughout the year.

And what capabilities in the Fennec-Hiers program have kind of been the biggest drivers of improvement or where you kind of sought to drive adherence improvement from?

Yeah, I think it's just redesigning the program to really be focused on giving this product and potentially in the home setting with our partners. We have partners that and organizations that we had set up to make sure this product could be administered there. So there are a whole bunch of different details, Chase, I can walk through with you offline, but those details needed to be really ironed out to make sure that that experience went well in when we give this product at home. Because remember, we're giving this product in some cases six hours after, in all cases, six hours after supply has been given. So in the home setting, it's all the details. I have to be ironed out to make sure that that

administration goes well. Yeah, and Chase, I'll just add a little bit, as you know, but just to make other people aware, when we're administering in the AYA population, largely done outpatient or as Jeff did said, in the home health setting.

So

the education of the product, the awareness, and in particular, the administration and what to expect, the antiemetics, the proper hydration. And so we've really put a focused effort and a concentrated effort with our FENECHIERS program and with our FENECHIERS program. So that all speaks well to what progress we've made in the last quarter, but also what we hope to happen throughout the year.

Great. And then Robert, can you maybe just speak to, so OPEC's call it flat in the Q2, and then we should see a little bit of a step down in the back half, it sounds like. And then just as far as kind of how that launch with Norgene has went so far, I mean, has that kind of been along, I know it's early, but along kind of what expectations were and how does that inform your confidence and kind of future milestones over the next 12 months?

Sure. Yeah, with the OPEC, yes, as stated in the remarks and in the script, it's front-end loaded for the year. That's just the spending patterns. And also as we get into, you know, we're trying to create additional awareness contracts, generally half upfront and then advertised over the rest of the year. So that's just traditional. It will see a tailing off in particular as we start Q3 and Q4. Norgene, we are, we're very enthused. You know, as we stated, they've launched in the UK with an official list pricing, about 10% less than the US, but we're excited about that. Germany as well, it's early on, but we're really pleased with the progress. They've commented on some positive indicators of engagement and uptake. So we look forward to giving you more updates and material updates as the quarters progress. As it relates to the sales milestones, there are two milestones we've communicated before that are a particular note as it relates to 2025. One is the official pricing in Germany that has one milestone related to it. And the second one would be for the first year sales. So as we get closer towards the end of 2025, we hope to give some more progress updates as it relates to those milestones.

Great. Thanks, guys. Congrats on the progress. Thanks, Jason.

Thank you. As a reminder to ask a question, please press star 1-1. Our next question comes from Sudan Loganathan with Stevens. Your line is open.

Hi, good morning. Thanks for taking my questions and, you know, great to hear about your new targeting strategy and how it's really showing in the strong first quarter. You know, on that front, do the prescribers know where they land on the tiering algorithm that you have? And, you know, is there any incentives in terms of reimbursements that they may get, you know, if a tier 2, tier 3 prescriber were able to move up to be considered a tier 1?

Yeah, I mean, we don't, Sudan, thanks for the question. I appreciate it. And yeah, you know, we don't typically share that information with our providers. Obviously, they are, they realize they're high prescribers of cis-flat, and that's one of the reasons why we're in their offices trying to educate them. And I think many of them realize that, you know, the impact of ototoxicity is having. I think the more, where we see the interest and the reason why we target these high prescribers is because they do see the impact of what's happening. And in some cases, there's still a significant lack of awareness, not only of PEDMARC, but also of what the impact of ototoxicity is having on their patients. And so I think it's really critical for us to get to start there and to start at that top tier. When it comes to physicians throughout that tiering or that targeting process, we're starting at tier 1 because of our size and because of the amount of folks that we have out there. But eventually, we'll move down throughout, and we shouldn't see any differences in reimbursement or any differences in our conversations as you start to move out throughout the rest of

that list.

There is no difference in terms of our pricing or reimbursement as it relates to the tiers. It's really more so that we can focus our commercial team on those top level accounts. But obviously, if we make progress on a tier 2 or a tier 3, we're just as focused and provided just equal support as well as pricing and reimbursement options.

Yeah, that's great to hear. And currently, regionally, at least in the United States, do you have pretty much most regions covered now among these tier 1 accounts in each region at this point that you're honed in on, or is there areas that still need to be targeted and maybe just get more up and hold in certain areas in the United States?

We're now deploying our commercial organization throughout the United States, and this tiering, or these focused and large academic centers and large community centers are being targeted by our commercial organization. So it's throughout the country.

Okay, cool. And then next on the, since you've kind of been on the market now for a year, you may be able to see the differences between the pharmacy formulation, the compounding component versus pen marker, just how much of a breakdown there could be between the two. More education and the ability to get out to the physicians and prescribers kind of helped get more traction there, or do you still see a small percentage of maybe some company pharmacies coming through trying to get solution out to education that way, too, and any way to eat into that if possible?

Yeah, no, it's a good question. I think where you're asking is, are we seeing any inroads even in the, not just AWA, but in the pediatric setting and in the counts that potentially were compounding in the past? And our medical team has, and I've asked them to continue to target these institutions, and we've had some really exciting discussions with institutions where we've maybe in the past been kind of shut out of those discussions because of the compounding issue and any issue with reimbursement and the DRGs. So we're re-engaging in every instance that we can in these organizations, and I'm hoping to share potentially some successes in the future with some of these discussions that we're having. But this is all really surrounding around, I think, as we upgraded and improved our competencies with our medical team.

Gotcha, great. One more last one, if I can squeeze it in. It may be more a question for Robert. In terms of the revenue growth and the progress that you're making, maybe second half of this year being a little bit better on that side, is there a revenue number with the current level of OPEX, or maybe slightly lower, that you think that you can consistently break even or also obviously be EPS positive going forward? Is that something that we can maybe expect for the second half of this year?

Yeah, thanks for the question, Sudan. I mean, as stated, we're pleased with two consecutive quarters of growth, and I think that should be specifically highlighted and noted. But we're not done yet. So our goal is to continue that growth throughout the year. We are focused on the back half of the year as having that growth from all these pillars and the foundation put into place with the initiatives, including our new commercial leadership team, augmentation of staff, etc. So we look forward to giving you more progress there as it relates to cash flow break even, another metric that for us internally is very, very important. We were close to it in Q4, and but what hasn't changed is the total revenue product sale number that we need to get there, and that's roughly eight and a half to nine million dollars of sales. As I stated, for the year, we will have roughly 33 to 34 million of cash OPEX. So that's how we think of it internally. From a gap EPS perspective, there is some fluctuation quarter to quarter, primarily based on the stock-based comp with the higher parts obviously being in Q1. But if we get to those levels, eight and a half, nine million, we start generating cash, we start generating earnings, and internally that's a big focus for us.

I appreciate all the answers to questions, and congrats on the great quarter too.

Thanks. Thanks for the questions. Thank you. Our next question comes from Jason McCarthy with Maxim Group. Your line is open.

Hey guys, this is Michael Kinovich on the line. Thank you so much for taking my questions today. No problem. Hi Michael. I just wanted to see if you could touch a little bit on where you're making these initial inroads into the AYA setting. Is this mostly in those the smaller proportion of patients that are treated at those NCI centers, or are you meaningfully penetrating now into the community setting?

Yeah, we're at the NCI centers. We've said the past are critical obviously for this, and where they have these AYA centers of excellence, and you see those in multiple places around the country. And those are places obviously we want to target because we know that a lot of the AYA patients will get treated in these centers. But we're also seeing this though as we move out into the community and some of these, and I think our targeting has really kind of allowed us to do that, to get into places where we typically probably wouldn't have gone, not just in the center itself, but in these community settings. So we're seeing growth in both places. I think the community setting, as well as the academic, are probably, as we get much more focused on our efforts, will play critical roles in both settings. So I can't tell you that one is right now more important than the other, but we've got a team that can be able to do that and be able to approach these top tier targets and these large cis-black users, whether they're in the academic or community setting.

All right, thank you. And then just on the community setting, in particular some of the infusion centers, has the operating hours of the centers remained a challenge for this AYA setting, or are some of the initiatives that you're working on kind of overcoming that challenge?

Yeah, yeah. And it's a really good question because, and that's why I mentioned the FENEC-HERES enhancements that we had to make. And it is something that we needed to make, because when a physician realizes that he wants to prevent auto toxicity, but doesn't have the ability, doesn't have a chair to have that available because their center closes at a certain time, that's when we move in with FENEC-HERES and with that team to be able to move into home health and into administrating outside that infusion center. Some infusion centers do stay open later, and those in a lot of cases will administer PedBARC in that center. But we want to make it seamless to the point where if there is a situation where a patient wants to get this outside of these infusion centers that we have a program available. It's easy. It allows the patient to be able to be confident that this product can be given in a home setting. And we now have achieved that. We've achieved multiple administrations of PedBARC and AYA patients in the home. And I feel really, really confident that this is a big opportunity for us as we move forward.

All right. Thank you. I really appreciate the additional clarity.

You got it. Thanks for the questions.

Thank you. As a reminder to ask a question, please press star 1-1 on your telephone. Again, that is star 1-1 to ask a question. Our next question comes from Ram Selvaraju with HC Wainwright. Your line is open.

Hi. Thanks very much for taking my questions. Just on the ex-US front, can you maybe give us a sense of your most updated thinking regarding any additional remaining ex-US territories that you see as particularly strong potential future opportunities for PedBARC? And also, on the European side, if you could maybe run through for us what you expect to be the cadence of new -by-country introductions of PedMarxI as we look through the remainder of 2025, above and beyond the countries in which the product obviously has already been launched.

Yeah. There's the big five in Europe. They're focused on moving. Again, with, of course, Scotland just coming on and getting approval is exciting, but again, another country, but obviously a small market, but it's still impactful. You can think of countries as they focus themselves is the next up is Spain, is Italy, and France. You can start to think through how to get there. Obviously, then really continuing to expand both in Germany and the UK as the launches really just only got started a month or two in the first quarter. The second quarter will really be the first full quarter of the launches in both those countries as well. We continue to be excited and bullish on what it is that they're doing. They've got a great team. We meet with them often. We share best practices and we share data that we can gather, but it goes both ways as well. We're learning from them. There are milestones that Robert talked about that are potentially achievable towards the end of this year. We're going to stay close to them on making sure that those get achieved.

Just briefly, secondly, you had previously talked, and I suppose this is really a question for Jeff, about the possibility of looking at other strategic opportunities, particularly in the context of oncology supportive care. I was just wondering if you had any updated thoughts on that front or if at this juncture at least you can give us a sense of when you think it would be most appropriate to look into that further and possibly identify assets or product marketing opportunities that might be synergistic with or creative to the PEDMARC value opportunity in the United States. Thank you.

That's a good question. I really wanted to come in and get the organization structured correctly and also executing correctly. The first quarter is really my second full quarter with the organization. I really now are starting to feel comfortable with the execution and the way we're structured and we have the right leadership in this organization. Now you start to think, all right, and we have had people in the past, even in my time here in the last six months, reach out that are in the supportive care space as well as not in the supportive care space to say, hey, we see what you guys are building. Are there synergies there? We're going to continue to look at that. I think Robert mentioned about our financial situation as we move throughout the year and sales continue to grow. This is definitely an option not only here but also as we talked about Japan and partnership potential opportunities if that brings itself to light as well as we get more of the data finalized. We have a couple of opportunities like that that I think are really critical for the future and also are additive to only what we're doing in the commercial organization here in the U.S. but those opportunities are additive to what it is that we potentially could deliver.

That's a good question. Thank you.

Thank you. Thank you. I'm showing no further questions at this time. I would now like to turn it back to Jeff Hackman for closing remarks.

Thank you and thanks for the questions, everyone and being a participant on the call. In closing, I would like to say that Q1 was really a pivotal and exciting start to this year for the company. It marked a really strong execution of our team. It marked a strategic clarity and real momentum and we want to continue that momentum and you'll see that as we go throughout the year. We're encouraged by the early impact of our foundational work and remain to be focused on building a sustainable and valuable business here. Through deeper engagement, as I mentioned, smarter support and continued innovation in this space. So thanks for joining today. I really appreciate it. Robert and I look forward to keeping you updated on our progress throughout the year. So thank you.

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