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 Phenix Chief Financial Officer Robert Andrade.

Thank you, Operator, and good morning, everyone. We appreciate you joining us today for Phenix Pharmaceutical's first quarter of 2025 Earnings Conference Call, during which we will review our financial results as well as provide a general business update. Joining me from FENIC 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 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.

Thank you, Robert. And good morning, everyone. 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 lists 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 Cisplatin prescribers nationally, prioritizing tiers like Tier 1 through 5, or those who treat high number of patients with Cisplatin, allowing us to focus on engagements 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 1 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 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 Fennec estimates that approximately 20,000 cisplatin chemotherapy patients are treated annually in the primary 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 cisplatin-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, Fennec 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, Fennec'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 PHENIC HEARS 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, streamline reimbursement, and expand home nursing capabilities. PHENIC HEARS 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 with Pedmark outside the U.S. Following our exclusive licensing agreement that Fennec executed back in March 2024 with Norgene Pharmaceuticals, the product has now launched commercially in Germany and in the U.K. And just this past week, Norgene announced that the Scottish Medicine Consortium, or SMC, has accepted PEDMARC-C for use in Scotland. Collectively, these recent launches mark important steps in achieving Fennec'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 STS-J01, evaluating PEDMARC was fully now enrolled as of October 2024. The clinical trial STS-J01 evaluates the efficacy and safety of PEDMARC in reducing autotoxicity induced by cisplatin in children and AYAs with localized 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 in 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 Penmark. 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 year-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 the Norwegian Partnership. To be clear, and as stated previously, European pre-commercialization expenses are not expected in 2025. The company recorded $6.1 million in G&A 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, G&A expenses were consistent on a year-over-year basis and increased quarter-over-quarter, largely due to non-cash-based stock compensation traditionally done in the first fiscal quarter. 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 25 to 24, 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 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 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. So now that you've got a little bit more experience in that segment of the market, can you cue us in on kind of what the average number of vials per patient per full treatment has been and kind of how that's compared to your expectations and then kind of what percentage of patients are kind of making it through that full course and maybe how that has improved and, you know, 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, you know, 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 range is 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 is about getting Fennec Heers in the right place. You know, Fennec Heers 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 use 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 Fentacures 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 Fentacures 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 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 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 the supply has been given. So in the home setting, all the details 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 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 Fennec Hears program and with our medical team that, as you know, we've augmented. So I think 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 OPEX 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 OPEX, yes, as stated in the remarks and in the script, it's front-end loaded for the year. That's just the spending patterns. Also, as we get into, you know, we're trying to create additional awareness Contracts generally half up front and then amortized 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're very enthused. 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 that we've communicated before that are of 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 25, 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 gut first quarter. You know, on that front, you know, do the prescribers know where they land on the tiering algorithm that you have? And, you know, is there a

any uh incentives in terms of reimbursements uh that they may get you know if they did if a tier two tier three prescriber were able to uh move up to be considered a tier one 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 with our providers um obviously they are um they realize they're high prescribers of cisflatin that's one of the reasons why we're were in their offices trying to educate them. And I think many of them realized 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 of what the impact of autotoxicity is having on their patients. And so I think it's really critical for us 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 one because of our size and because of the amount of folks that we have out there. 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.

Great to hear.

Just to add, 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 provide 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 1s? Do you have Tier 1s accounts in each region at this point that you're honed in on? Or is there areas that are still need to be kind of targeted and maybe just get more, you know, a foothold in certain areas in the United States?

You know, we're covering, yeah, we're now deploying our commercial organizations throughout the United States in this tiering or these focused in large academic centers and large community centers. um, are being targeted by our, by our commercial organization. So it's, it's throughout the country.

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

Yeah, no, it's a good question, you know, and I think where you're asking is, are we seeing any inroads even in the, not just AY, but in the pediatric setting and in accounts that potentially were compounding in the past? And, you know, our medical team has, you know, 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 have been kind of shut out of those discussions because of the compounding issue and any issue with reimbursement and the DRGs. So we're reengaging 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

uh you know our competencies uh with our medical team gotcha great well one more last one if i can squeeze it in uh you know uh maybe more a question for robert you know in terms of the revenue growth and you know the progress that you're making maybe the second half of this year being a little bit better on that side. You know, is there a revenue number and with the current level of OPEX or maybe slightly lower that you think that you can consistently break even or also, you know, 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, et cetera. So we look forward to giving you more progress there. As it relates to cash flow breakeven, another metric that for us internally is very, very important. We were close to in Q4, but what hasn't changed is the total revenue product sale number that we need to get there. And that's roughly $8.5 to $9 million 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 GAAP 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, $8.5 million, $9 million, we start generating cash, we start generating earnings, and internally that's a big focus for us.

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

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

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

Yeah, the NCI centers, we've said in the past, are critical, obviously, for this, and where they have these AYA centers of excellence, right? 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 to places where uh you know we typically probably wouldn't have gone um not just in the center itself but but um you know in these uh in these community settings so we're seeing growth in both places I think the community setting uh as well as the academic are probably, you know, as we get, you know, much more focused on, you know, 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, you know, but we've got a team that can be able to do that and be able to approach, you know, these top-tier targets and these large cis-flatin users, whether they're in the academic or community settings.

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 Fennec Hears enhancements that we had to make. And it is something that we need it to make because when a physician realizes that he wants to prevent autotoxicity but doesn't have the ability, doesn't have a chair to have that, you know, available because their center closes at a certain time, that's when we move in with Fenechers and with that team to be able to move into home health. and into administrating outside that, you know, that infusion center. Some infusion centers do stay open later, you know, and those, you know, in a lot of cases will administer Pedbark 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 Pedmark 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 PEDMARC? And also, on the European side, if you could maybe run through for us what you expect to be the cadence of new country-by-country introductions of PEDMARC-C as we look through the remainder of 2025, above and beyond the countries in which the product obviously has already been launched.

Yeah, you know, there's the big five, right, in Europe. They're focused on moving, you know, 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, you know, it's still impactful. You know, you can think of, you know, countries as they focus themselves is the next up is Spain, is Italy, and France. And you can start to kind of think through how the, you know, and obviously then really continuing to expand, you know, both in Germany and the UK as the launches really just only got started, you know, a month or two in the first quarter. So they really You know, the second quarter will really be the first full quarter of the launches in both those countries as well. So, you know, 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. You know, we share best practices and we share data that we can gather. But it goes both ways as well. You know, we're learning from them. You know, there are milestones. that Robert talked about that are potentially achievable towards the end of this year. And, you know, we're going to stay close to them on making sure that those get achieved.

And just very briefly, secondary, you know, 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. So I was just wondering if, you know, you had any updated thoughts on that front or if at this juncture, you know, at least you can kind of give us a sense of when you think it would be most appropriate to look into that further and possibly identify, you know, assets or product marketing opportunities that might be synergistic with or accretive to the PEDMARC value opportunity in the United States. Thank you.

Yeah, that's a good question. You know, I really wanted to come in and get the organization, you know, structured correctly and also executing correctly. And so, you know, the first quarter is really my second full quarter with the organization. And 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. So, yeah, now you start to kind of think, all right, and we have had people in the past, even in my time here in the last six months, you know, 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, you know, our financial situation as we've moved 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. So we have a couple of opportunities like that that I think are really critical for the future and also are additive to not only what we're doing in the commercial organization here at the U.S., you know, 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. So, in closing, you know, I'd like to say that Q1 was really a pivotable a pivotal and exciting start to this year for the company. It marked 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.