NASDAQ:FENC Fennec Pharmaceuticals Q1 2025 Earnings Report $7.87 -0.10 (-1.25%) Closing price 05/23/2025 04:00 PM EasternExtended Trading$7.87 0.00 (0.00%) As of 05/23/2025 04:04 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Fennec Pharmaceuticals EPS ResultsActual EPS-$0.04Consensus EPS -$0.12Beat/MissBeat by +$0.08One Year Ago EPS$0.41Fennec Pharmaceuticals Revenue ResultsActual Revenue$8.51 millionExpected Revenue$8.18 millionBeat/MissBeat by +$330.00 thousandYoY Revenue GrowthN/AFennec Pharmaceuticals Announcement DetailsQuarterQ1 2025Date5/13/2025TimeBefore Market OpensConference Call DateTuesday, May 13, 2025Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Fennec Pharmaceuticals Q1 2025 Earnings Call TranscriptProvided by QuartrMay 13, 2025 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Good morning, ladies and gentlemen, and welcome to FENIC Pharmaceuticals First 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 call is being recorded. Now, I would like to turn the conference over to Fenics Chief Financial Officer, Robert Andrade. Speaker 100:00:30Thank you, operator, and good morning, everyone. We appreciate you joining us today for Pfenex Pharmaceuticals first quarter two thousand twenty five 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. Speaker 100:01:23S. 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 Phenex's website, www.phenexpharma.com, where it will be available for the next thirty days. Speaker 100:01:57And with that, I will now turn the call over to Jeff Hackman. Speaker 200:02:01Thank 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 PedMark segments really began back in Q4 twenty twenty four. Much of the work was implemented though in Q1 of this year. Speaker 200:02:38Therefore, 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. Speaker 200:03:13This 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 one through five, 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 one targets prescribed for Petmark 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 Speaker 100:04:37settings. As a part Speaker 200:04:39of 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 this segment is very significant in The US. FENIC estimates that approximately twenty thousand 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. Speaker 200:05:28Our 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 path within academic institutions in these large community practices. During this meeting, Fennick'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 HEAR's patient support program to ensure a more seamless, supportive experience for both providers and patients at every step of the PetSmart journey. Speaker 200:06:35These upgrades designed to improve access, streamline reimbursement, and expand home nursing capabilities. PhenicHears is critical for the health care providers' 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. Speaker 200:07:32As awareness increases, our program ensures providers are equipped with the right tools and support to proactively engage patients who may benefit from PetBark 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 US. Following our exclusive licensing agreement that Senec 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 Pedmarkci for use in Scotland. Collectively, these recent launches mark important steps in achieving Phenix mission of expanding access to Pedmark and Pedmarkci to cancer patients at risk of hearing loss in The European Union and The UK. Speaker 200:08:36Also on the global front, the investigator initiated trial in Japan or STSJ-one evaluating PEDmark was fully now enrolled as of October 2024. The clinical trial STSJ01 evaluates the efficacy and safety of Pedmark 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 twenty twenty five with potential evaluation of both the registration and partnering or licensing of Pedmark in Japan thereafter. Looking ahead, we are building a solid foundation with a laser focused vision, as I mentioned, as we entered into 2025. Speaker 200:09:30This 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 disciplined 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 health care providers from trial to adoption of PEDMAR. The strong momentum has continued in early q two, 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. Speaker 100:10:15Thank you, Jeff. Our press release contains details of our financial results for the February, 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 February, the company recorded net product sales of approximately 8,800,000.0 compared to $7,400,000 in the first quarter of twenty twenty four. This reflects 18% growth compared to the same period last year and an 11% increase over the fourth quarter of twenty twenty four. Speaker 100:10:59Of 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 February when all the foundational pillars and initiatives we are putting in place are expected to materially impact the growth of Penmark. The company recorded $2,900,000 in selling and marketing expenses in the first quarter of twenty twenty five compared to $3,900,000 in the fourth quarter of twenty twenty four and $5,200,000 in the first quarter of twenty twenty four. The decrease on a year over year basis is primarily attributable to the elimination of expenses associated with European precommercialization activities, which occurred in 2024 prior to the announcement of the Norgene partnership. To be clear, and as stated previously, European precommercialization expenses are not expected in 2025. Speaker 100:12:09The company recorded $6,100,000 in G and A expenses in the first quarter of twenty twenty five compared to $4,100,000 in the fourth quarter of twenty twenty four and $5,900,000 in the comparable quarter of twenty twenty four. For the first quarter of twenty twenty five, G and A expenses were consistent on a year over year basis and increased quarter over quarter largely due to noncash based stock compensation traditionally done in the first fiscal quarter. Cash and cash equivalents were $22,600,000 as of 03/31/2025. Company burned approximately $4,000,000 in cash in the first quarter of twenty twenty five. As stated in our March 2025 call, we remain confident in the full year cash operating expenses to be similar in 25,000,000 to 24,000,000 or approximately 33,000,000 This includes a step up in marketing expenses and increased headcount, offset by the elimination of European pre commercialization expenses. Speaker 100:13:16As 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 or overall financial performance. Operator, with that, we will now open up the call for questions. Operator00:14:03Our Our first question comes from Chase Knickerbocker with Craig Hallum. Your line is open. Speaker 300:14:26Good morning. Thanks for the questions. Just a couple kind of metrics I think would be helpful on the OA side first. So now that you've got a little bit more experience in that segment of the market, can you queue 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 how that's informed your patient support program? Speaker 200:15:01Sure. Hey, Chase. How are you? Thanks for the question. Yeah. Speaker 200:15:06We are seeing on average about 30 vials per patient in the AYD 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, we're seeing that that range is around fifty percent of the patients are getting through the full dose or full adherence. And so kind of some of the focus that I had mentioned was is about getting PhenicHERS in the right place. Speaker 200:15:51Know, PhenicHERS 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 Phenicears 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. Speaker 300:16:26And what capabilities in the FENACHERS program have kind of been the biggest drivers of improvement or where you kind of sought to drive adherence improvement from? Speaker 200:16:38Yeah, 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 and organizations that we had set up to to make sure this product be administered there. So there are a whole bunch of different details, Chase, I can walk through with you offline, but but those details needed to be really ironed out to make sure that that experience went well in, you know, when we gave when we give this product at home. Right? Because remember, we're given this product in some cases six hours after in many in all cases, six hours after supply has been given. Speaker 200:17:23So it's in the home setting, it it's all the all the details have to be ironed out to make sure that that that administration goes well. Speaker 100:17:32Yeah. And, Chase, I'll just add a little bit, as as you know, but just to make other people aware. When when you're when we're administering the AYA population largely done outpatient or as 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 Phenicears program and with our medical team that, as you know, we've augmented. Speaker 100:18:06So I think that is all all speaks well to what progress we've made in the last quarter, but also what what we hope to happen, throughout the year. Speaker 300:18:15Great. And then Robert, can you maybe just speak to so OpEx, call it flat into 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 a long I know it's early, but a long kind of what expectations were and how does that inform your confidence in kind of future milestones over the next twelve months? Speaker 100:18:42Sure. Yeah. With with the OpEx, yes, as stated in in in the in the remarks and in the script, it's front end loaded for the year. That's just the the spending patterns. And also, as we get into you know, we're trying to create additional awareness contracts, generally half upfront and then amortized over the rest of the year. Speaker 100:19:01So that's just traditional. It will see a tailing off, in particular, as we start q three and q four. Norgeen, we are we're very enthused. You know, as as we 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. Speaker 100:19:25It's early on, but we're really pleased with the progress. They've commented on some positive indicators of engagement and 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 we've communicated before that are of particular note as it relates to 02/2025. '1 is, the official pricing in Germany, that has one milestone related to it, and the second one would be for the first year sales. Speaker 100:20:04So as we get closer towards the end of twenty five, we hope to give, you know, some more progress updates as it relates to those milestones. Speaker 300:20:13Great. Thanks, guys. Congrats on the progress. Speaker 400:20:16Thanks, Jason. Operator00:20:17Thank you. Our next question comes from Sudan Lokanathan with Stephens. Your line is open. Speaker 400:20:31Hi, good morning. Thanks for taking my questions and great to hear about your new targeting strategy and how it's really showing in the stronger first quarter. On that front, do the prescribers know where they land on the tiering algorithm that you have? And is there any incentives in terms of reimbursements that they may get if a tier two, tier three prescriber were able to move up to be considered a tier one? Speaker 200:21:03Mean, we don't Suzanne, thanks for the question. I appreciate it. And yeah, we don't typically share that information with our providers. Obviously, they realize they're high prescribers of cisplatin. It's one of the reasons why we're in their offices trying to educate them, I think many of them realize that, you know, the impact of ototoxicity is having. Speaker 200:21:25I 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 Penmark, 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 one 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. Speaker 400:22:27Yeah. And great to hear. Speaker 100:22:28And just to add, there there is no there is no difference in in terms of our pricing or reimbursement, as it relates to the tiers. No. It's really more so that we can focus our commercial team, you know, on on those top level accounts. But, obviously, if we make progress on a tier two or a tier three, we're just as focused and and provide just equal support and as well as pricing and reimbursement options. Yeah. Speaker 400:22:54That's great to hear. And, you know, is currently, like, regionally, at least in The United States, do you have pretty much most regions covered now among, you know, the tier one do you have, like, tier one 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 a foothold in certain areas in The United States? Speaker 200:23:21You know, we're covering yeah. We're we're now deploying our commercial organization throughout The United States, this tiering or these these focused and large academic centers and large community centers are being targeted by our commercial organization. So it's throughout the country. Speaker 400:23:39Okay. Cool. And then next on, you know, the since you kind of been on the market now for, you know, for a year and you may be able to see the differences between 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, you know, the ability to get out to the physicians and prescribers kind of helped get Credmark 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 the solution out to to patients that way too and any way to eat into that if possible? Speaker 200:24:24Yeah. No. It's a good question. You know? And I think what what you're asking is is is is are we seeing any inroads even in the not just AYA, but in the pediatric setting and in accounts that potentially were compounding in the past? Speaker 200:24:38And, 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 our competencies with our medical team. Speaker 400:25:23Gotcha. Great. One more last one, if I can squeeze it in. Maybe more a question for Robert. In terms of the revenue growth and, you know, the progress that you're making, maybe second half of this year being 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 breakeven or also, you know, obviously be EPS positive going forward? Speaker 400:25:48Is that something that we can maybe expect for the second half of this year? Speaker 100:25:52Yeah. Thanks for the question, Sudan. I mean, as stated, we're 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. Speaker 100:26:10We are focused on the back half of the year as having that that growth from all these pillars and these and the foundation put into place with the the initiatives, including our new commercial leadership team, augmentation of staff, etcetera. So we look forward to giving you more progress there. As it relates to cash flow breakeven, another metric that for us internally is is very, very important. We were close to in the in q four, 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 34,000,000 of cash OpEx. Speaker 100:26:54So that's how we think of it internally. From a GAAP EPS perspective, there is some fluctuation quarter to quarter primarily based on, you know, on the stock based comp with with the higher parts obviously being in q one. But if we get to those levels, 8 and a half, 9 million, we start generating cash, we start generating earnings. And internally, that's a big focus for us. Speaker 400:27:20I appreciate all the answers to the questions, and and congrats on the great quarter too. Speaker 200:27:24You bet. Thanks. Thanks for the Thank you, Dan. Operator00:27:27Thank you. Our next question comes from Jason McCarthy with Maxim Group. Your line is open. Speaker 100:27:34Hey, guys. This is Michael Okunowicz on the line. Thank you so much for taking my questions today. No problem. Hi, Michael. Speaker 200:27:42So I just wanted Speaker 100:27:43to see if you could touch a little bit on where you're making these initial inroads into the AYA settings. Is this mostly in those the smaller proportion of patients that are treated at those NCI centers, Speaker 400:27:58or are Speaker 100:27:58you meaningfully penetrating now into the community setting? Speaker 200:28:04Yeah. The NCI centers, we've said in the past, are critical, obviously, 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 the and I think our targeting has really kind of allowed us to do that, to get into to places where, you know, we typically probably wouldn't have gone, not just in the center itself, but but, you know, in these in these community settings. So we're seeing growth in both places. Speaker 200:28:52I think the community setting as well as the academic are are probably, you know, as we get, you know, much more focused on on, you know, our efforts, will will play critical roles for in in both settings. So I 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 and be able to approach, you know, these top tier targets and these large Cisplatin users, whether they're in the academic or community setting. Speaker 100:29:26Alright. 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? Speaker 200:29:45Yeah. And it's a really good question because and that's why I mentioned the phenakirs 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 autotoxicity, 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 FENICHERS 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. Speaker 200:30:51It 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, you know, administrations of Pedmark and AYA patients in the home. And, you know, I feel really, really confident that this is a big opportunity for us as we move forward. Speaker 100:31:18Alright. Thank you. I really appreciate the additional clarity. Speaker 200:31:21You got it. Thanks for the questions. Operator00:31:24Thank you. Our next question comes from Ram Selvaraju with H. C. Wainwright. Your line is open. Speaker 500:31:41Hi, thanks very much for taking my questions. Just on the ex U. S. Front, can you maybe give us a sense of your most updated thinking regarding any additional remaining ex U. S. Speaker 500:31:52Territories that you see as particularly strong potential future opportunities for Pedmark? 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 Pedmarkci, as we look through the remainder of 2025 above and beyond the countries in which the product obviously has already been launched? Speaker 200:32:19Yeah. 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 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 of, countries, as we as they focus themselves, is the next up are is Spain, is Italy, and France. Speaker 200:32:51And 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 on what it is that they're doing. They've got a great team. We meet with them often. Speaker 200:33:24You know, we share best practices, and and we share data that we can gather, and and but 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 we're gonna stay close to them on making sure that those get achieved. Speaker 500:33:51And just very briefly, secondary, 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 had any updated thoughts on that front, or if at this juncture, 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 assets or product marketing opportunities that might be synergistic with or accretive to the Pedmark value opportunity in The United States? Thank you. Speaker 200:34:34Yeah, it's a good question. You know, really wanted to come in and get the organization you know, structured correctly and also executing correctly. And so, you know, the the first quarter is really my my second full quarter with the 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 kinda think, alright. 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, we, you know, we like, we see what you guys are building, Are there synergies there? Speaker 200:35:23We're gonna continue to look at that. I think Robert mentioned about, you know, 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, you know, 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 in The US, but those opportunities are additive to to what it is that we potentially could deliver. That's a good question. Speaker 400:36:07Thank you. Speaker 100:36:08Thank you. Operator00:36:10Thank you. I'm showing no further questions at this time. I would now like to turn it back to Jeff Hackman for closing remarks. Speaker 200:36:18Thank you, and thanks for the questions everyone and being a participant on the call. So in closing, I'd like to say that Q1 was really 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 as I mentioned, smarter support, and continued innovation in this space. Speaker 200:36:58So 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. Operator00:37:08This concludes today's conference call. Thank you for participating. You may now disconnect.Read morePowered by Key Takeaways Fenics implemented a data-driven targeting model that tiers cisplatin prescribers and focused on top academic and community accounts—early adoption seen at Tampa General Hospital, City of Hope, and other tier-one centers. The company expanded beyond pediatrics into the AYA segment, estimated at ~20,000 patients annually with favorable outpatient reimbursement, and is seeing early traction in adolescent and young adult oncology settings. Upgrades to the FENICHEARs patient support program streamlined access, reimbursement, and home nursing capabilities, driving improved patient adherence and provider engagement across the treatment journey. Internationally, PedmarkCI has launched in Germany and the UK with Scottish approval secured, while Japan’s STSJ01 trial is fully enrolled and expected to yield results in H2 2025 toward potential registration. In Q1 2025, net product sales reached $8.8 million (up 18% YoY and 11% QoQ), marking two consecutive quarters of growth, and management targets cash flow breakeven at ~$8.5–9 million in quarterly sales against ~$33 million annual OpEx. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallFennec Pharmaceuticals Q1 202500:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Fennec Pharmaceuticals Earnings HeadlinesHC Wainwright Issues Optimistic Forecast for FENC EarningsMay 22 at 2:39 AM | americanbankingnews.comFennec Pharmaceuticals' (FENC) "Buy" Rating Reaffirmed at HC WainwrightMay 22 at 1:58 AM | americanbankingnews.comThe Trump Dump is starting; Get out of stocks now?The first 365 days of the Trump presidency… Will be the best time to get rich in American history.May 24, 2025 | Paradigm Press (Ad)Fennec Pharmaceuticals at BioConnect: Strategic Moves and Market ExpansionMay 22 at 12:43 AM | investing.comFennec - A Sound Case For Long-Term Growth? May 21 at 10:20 AM | rttnews.comInsider Buying: Jeffrey Hackman Acquires 15,000 Shares of Fennec Pharmaceuticals Inc (FENC)May 20, 2025 | gurufocus.comSee More Fennec Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Fennec Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Fennec Pharmaceuticals and other key companies, straight to your email. Email Address About Fennec PharmaceuticalsFennec Pharmaceuticals (NASDAQ:FENC)., a biopharmaceutical company, develops product candidates for use in the treatment of cancer in the United States. Its lead product candidate is the Sodium Thiosulfate, which has completed the Phase III clinical trial for the prevention of cisplatin induced hearing loss or ototoxicity in children. The company was formerly known as Adherex Technologies Inc. and changed its name to Fennec Pharmaceuticals Inc. in September 2014. 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There are 6 speakers on the call. Operator00:00:00Good morning, ladies and gentlemen, and welcome to FENIC Pharmaceuticals First 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 call is being recorded. Now, I would like to turn the conference over to Fenics Chief Financial Officer, Robert Andrade. Speaker 100:00:30Thank you, operator, and good morning, everyone. We appreciate you joining us today for Pfenex Pharmaceuticals first quarter two thousand twenty five 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. Speaker 100:01:23S. 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 Phenex's website, www.phenexpharma.com, where it will be available for the next thirty days. Speaker 100:01:57And with that, I will now turn the call over to Jeff Hackman. Speaker 200:02:01Thank 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 PedMark segments really began back in Q4 twenty twenty four. Much of the work was implemented though in Q1 of this year. Speaker 200:02:38Therefore, 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. Speaker 200:03:13This 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 one through five, 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 one targets prescribed for Petmark 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 Speaker 100:04:37settings. As a part Speaker 200:04:39of 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 this segment is very significant in The US. FENIC estimates that approximately twenty thousand 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. Speaker 200:05:28Our 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 path within academic institutions in these large community practices. During this meeting, Fennick'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 HEAR's patient support program to ensure a more seamless, supportive experience for both providers and patients at every step of the PetSmart journey. Speaker 200:06:35These upgrades designed to improve access, streamline reimbursement, and expand home nursing capabilities. PhenicHears is critical for the health care providers' 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. Speaker 200:07:32As awareness increases, our program ensures providers are equipped with the right tools and support to proactively engage patients who may benefit from PetBark 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 US. Following our exclusive licensing agreement that Senec 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 Pedmarkci for use in Scotland. Collectively, these recent launches mark important steps in achieving Phenix mission of expanding access to Pedmark and Pedmarkci to cancer patients at risk of hearing loss in The European Union and The UK. Speaker 200:08:36Also on the global front, the investigator initiated trial in Japan or STSJ-one evaluating PEDmark was fully now enrolled as of October 2024. The clinical trial STSJ01 evaluates the efficacy and safety of Pedmark 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 twenty twenty five with potential evaluation of both the registration and partnering or licensing of Pedmark in Japan thereafter. Looking ahead, we are building a solid foundation with a laser focused vision, as I mentioned, as we entered into 2025. Speaker 200:09:30This 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 disciplined 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 health care providers from trial to adoption of PEDMAR. The strong momentum has continued in early q two, 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. Speaker 100:10:15Thank you, Jeff. Our press release contains details of our financial results for the February, 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 February, the company recorded net product sales of approximately 8,800,000.0 compared to $7,400,000 in the first quarter of twenty twenty four. This reflects 18% growth compared to the same period last year and an 11% increase over the fourth quarter of twenty twenty four. Speaker 100:10:59Of 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 February when all the foundational pillars and initiatives we are putting in place are expected to materially impact the growth of Penmark. The company recorded $2,900,000 in selling and marketing expenses in the first quarter of twenty twenty five compared to $3,900,000 in the fourth quarter of twenty twenty four and $5,200,000 in the first quarter of twenty twenty four. The decrease on a year over year basis is primarily attributable to the elimination of expenses associated with European precommercialization activities, which occurred in 2024 prior to the announcement of the Norgene partnership. To be clear, and as stated previously, European precommercialization expenses are not expected in 2025. Speaker 100:12:09The company recorded $6,100,000 in G and A expenses in the first quarter of twenty twenty five compared to $4,100,000 in the fourth quarter of twenty twenty four and $5,900,000 in the comparable quarter of twenty twenty four. For the first quarter of twenty twenty five, G and A expenses were consistent on a year over year basis and increased quarter over quarter largely due to noncash based stock compensation traditionally done in the first fiscal quarter. Cash and cash equivalents were $22,600,000 as of 03/31/2025. Company burned approximately $4,000,000 in cash in the first quarter of twenty twenty five. As stated in our March 2025 call, we remain confident in the full year cash operating expenses to be similar in 25,000,000 to 24,000,000 or approximately 33,000,000 This includes a step up in marketing expenses and increased headcount, offset by the elimination of European pre commercialization expenses. Speaker 100:13:16As 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 or overall financial performance. Operator, with that, we will now open up the call for questions. Operator00:14:03Our Our first question comes from Chase Knickerbocker with Craig Hallum. Your line is open. Speaker 300:14:26Good morning. Thanks for the questions. Just a couple kind of metrics I think would be helpful on the OA side first. So now that you've got a little bit more experience in that segment of the market, can you queue 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 how that's informed your patient support program? Speaker 200:15:01Sure. Hey, Chase. How are you? Thanks for the question. Yeah. Speaker 200:15:06We are seeing on average about 30 vials per patient in the AYD 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, we're seeing that that range is around fifty percent of the patients are getting through the full dose or full adherence. And so kind of some of the focus that I had mentioned was is about getting PhenicHERS in the right place. Speaker 200:15:51Know, PhenicHERS 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 Phenicears 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. Speaker 300:16:26And what capabilities in the FENACHERS program have kind of been the biggest drivers of improvement or where you kind of sought to drive adherence improvement from? Speaker 200:16:38Yeah, 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 and organizations that we had set up to to make sure this product be administered there. So there are a whole bunch of different details, Chase, I can walk through with you offline, but but those details needed to be really ironed out to make sure that that experience went well in, you know, when we gave when we give this product at home. Right? Because remember, we're given this product in some cases six hours after in many in all cases, six hours after supply has been given. Speaker 200:17:23So it's in the home setting, it it's all the all the details have to be ironed out to make sure that that that administration goes well. Speaker 100:17:32Yeah. And, Chase, I'll just add a little bit, as as you know, but just to make other people aware. When when you're when we're administering the AYA population largely done outpatient or as 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 Phenicears program and with our medical team that, as you know, we've augmented. Speaker 100:18:06So I think that is all all speaks well to what progress we've made in the last quarter, but also what what we hope to happen, throughout the year. Speaker 300:18:15Great. And then Robert, can you maybe just speak to so OpEx, call it flat into 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 a long I know it's early, but a long kind of what expectations were and how does that inform your confidence in kind of future milestones over the next twelve months? Speaker 100:18:42Sure. Yeah. With with the OpEx, yes, as stated in in in the in the remarks and in the script, it's front end loaded for the year. That's just the the spending patterns. And also, as we get into you know, we're trying to create additional awareness contracts, generally half upfront and then amortized over the rest of the year. Speaker 100:19:01So that's just traditional. It will see a tailing off, in particular, as we start q three and q four. Norgeen, we are we're very enthused. You know, as as we 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. Speaker 100:19:25It's early on, but we're really pleased with the progress. They've commented on some positive indicators of engagement and 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 we've communicated before that are of particular note as it relates to 02/2025. '1 is, the official pricing in Germany, that has one milestone related to it, and the second one would be for the first year sales. Speaker 100:20:04So as we get closer towards the end of twenty five, we hope to give, you know, some more progress updates as it relates to those milestones. Speaker 300:20:13Great. Thanks, guys. Congrats on the progress. Speaker 400:20:16Thanks, Jason. Operator00:20:17Thank you. Our next question comes from Sudan Lokanathan with Stephens. Your line is open. Speaker 400:20:31Hi, good morning. Thanks for taking my questions and great to hear about your new targeting strategy and how it's really showing in the stronger first quarter. On that front, do the prescribers know where they land on the tiering algorithm that you have? And is there any incentives in terms of reimbursements that they may get if a tier two, tier three prescriber were able to move up to be considered a tier one? Speaker 200:21:03Mean, we don't Suzanne, thanks for the question. I appreciate it. And yeah, we don't typically share that information with our providers. Obviously, they realize they're high prescribers of cisplatin. It's one of the reasons why we're in their offices trying to educate them, I think many of them realize that, you know, the impact of ototoxicity is having. Speaker 200:21:25I 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 Penmark, 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 one 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. Speaker 400:22:27Yeah. And great to hear. Speaker 100:22:28And just to add, there there is no there is no difference in in terms of our pricing or reimbursement, as it relates to the tiers. No. It's really more so that we can focus our commercial team, you know, on on those top level accounts. But, obviously, if we make progress on a tier two or a tier three, we're just as focused and and provide just equal support and as well as pricing and reimbursement options. Yeah. Speaker 400:22:54That's great to hear. And, you know, is currently, like, regionally, at least in The United States, do you have pretty much most regions covered now among, you know, the tier one do you have, like, tier one 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 a foothold in certain areas in The United States? Speaker 200:23:21You know, we're covering yeah. We're we're now deploying our commercial organization throughout The United States, this tiering or these these focused and large academic centers and large community centers are being targeted by our commercial organization. So it's throughout the country. Speaker 400:23:39Okay. Cool. And then next on, you know, the since you kind of been on the market now for, you know, for a year and you may be able to see the differences between 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, you know, the ability to get out to the physicians and prescribers kind of helped get Credmark 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 the solution out to to patients that way too and any way to eat into that if possible? Speaker 200:24:24Yeah. No. It's a good question. You know? And I think what what you're asking is is is is are we seeing any inroads even in the not just AYA, but in the pediatric setting and in accounts that potentially were compounding in the past? Speaker 200:24:38And, 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 our competencies with our medical team. Speaker 400:25:23Gotcha. Great. One more last one, if I can squeeze it in. Maybe more a question for Robert. In terms of the revenue growth and, you know, the progress that you're making, maybe second half of this year being 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 breakeven or also, you know, obviously be EPS positive going forward? Speaker 400:25:48Is that something that we can maybe expect for the second half of this year? Speaker 100:25:52Yeah. Thanks for the question, Sudan. I mean, as stated, we're 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. Speaker 100:26:10We are focused on the back half of the year as having that that growth from all these pillars and these and the foundation put into place with the the initiatives, including our new commercial leadership team, augmentation of staff, etcetera. So we look forward to giving you more progress there. As it relates to cash flow breakeven, another metric that for us internally is is very, very important. We were close to in the in q four, 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 34,000,000 of cash OpEx. Speaker 100:26:54So that's how we think of it internally. From a GAAP EPS perspective, there is some fluctuation quarter to quarter primarily based on, you know, on the stock based comp with with the higher parts obviously being in q one. But if we get to those levels, 8 and a half, 9 million, we start generating cash, we start generating earnings. And internally, that's a big focus for us. Speaker 400:27:20I appreciate all the answers to the questions, and and congrats on the great quarter too. Speaker 200:27:24You bet. Thanks. Thanks for the Thank you, Dan. Operator00:27:27Thank you. Our next question comes from Jason McCarthy with Maxim Group. Your line is open. Speaker 100:27:34Hey, guys. This is Michael Okunowicz on the line. Thank you so much for taking my questions today. No problem. Hi, Michael. Speaker 200:27:42So I just wanted Speaker 100:27:43to see if you could touch a little bit on where you're making these initial inroads into the AYA settings. Is this mostly in those the smaller proportion of patients that are treated at those NCI centers, Speaker 400:27:58or are Speaker 100:27:58you meaningfully penetrating now into the community setting? Speaker 200:28:04Yeah. The NCI centers, we've said in the past, are critical, obviously, 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 the and I think our targeting has really kind of allowed us to do that, to get into to places where, you know, we typically probably wouldn't have gone, not just in the center itself, but but, you know, in these in these community settings. So we're seeing growth in both places. Speaker 200:28:52I think the community setting as well as the academic are are probably, you know, as we get, you know, much more focused on on, you know, our efforts, will will play critical roles for in in both settings. So I 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 and be able to approach, you know, these top tier targets and these large Cisplatin users, whether they're in the academic or community setting. Speaker 100:29:26Alright. 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? Speaker 200:29:45Yeah. And it's a really good question because and that's why I mentioned the phenakirs 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 autotoxicity, 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 FENICHERS 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. Speaker 200:30:51It 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, you know, administrations of Pedmark and AYA patients in the home. And, you know, I feel really, really confident that this is a big opportunity for us as we move forward. Speaker 100:31:18Alright. Thank you. I really appreciate the additional clarity. Speaker 200:31:21You got it. Thanks for the questions. Operator00:31:24Thank you. Our next question comes from Ram Selvaraju with H. C. Wainwright. Your line is open. Speaker 500:31:41Hi, thanks very much for taking my questions. Just on the ex U. S. Front, can you maybe give us a sense of your most updated thinking regarding any additional remaining ex U. S. Speaker 500:31:52Territories that you see as particularly strong potential future opportunities for Pedmark? 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 Pedmarkci, as we look through the remainder of 2025 above and beyond the countries in which the product obviously has already been launched? Speaker 200:32:19Yeah. 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 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 of, countries, as we as they focus themselves, is the next up are is Spain, is Italy, and France. Speaker 200:32:51And 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 on what it is that they're doing. They've got a great team. We meet with them often. Speaker 200:33:24You know, we share best practices, and and we share data that we can gather, and and but 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 we're gonna stay close to them on making sure that those get achieved. Speaker 500:33:51And just very briefly, secondary, 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 had any updated thoughts on that front, or if at this juncture, 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 assets or product marketing opportunities that might be synergistic with or accretive to the Pedmark value opportunity in The United States? Thank you. Speaker 200:34:34Yeah, it's a good question. You know, really wanted to come in and get the organization you know, structured correctly and also executing correctly. And so, you know, the the first quarter is really my my second full quarter with the 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 kinda think, alright. 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, we, you know, we like, we see what you guys are building, Are there synergies there? Speaker 200:35:23We're gonna continue to look at that. I think Robert mentioned about, you know, 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, you know, 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 in The US, but those opportunities are additive to to what it is that we potentially could deliver. That's a good question. Speaker 400:36:07Thank you. Speaker 100:36:08Thank you. Operator00:36:10Thank you. I'm showing no further questions at this time. I would now like to turn it back to Jeff Hackman for closing remarks. Speaker 200:36:18Thank you, and thanks for the questions everyone and being a participant on the call. So in closing, I'd like to say that Q1 was really 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 as I mentioned, smarter support, and continued innovation in this space. Speaker 200:36:58So 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. Operator00:37:08This concludes today's conference call. Thank you for participating. You may now disconnect.Read morePowered by