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spk09: Good morning, ladies and gentlemen, and welcome to the Fennec Pharmaceuticals First Quarter 2020 for Earnings and Corporate Update conference call. At this time, all participants are on 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 Fennec's Chief Financial Officer, Robert Andrade. Please go ahead.
spk05: Thank you, Operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceuticals First Quarter 2020. 2024 Earnings Conference Call, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning are Rusty Rykov, our Chief Executive Officer, and Adrian Hay, our Chief Operating Officer. 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 United States 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. With that, I will now turn the call over to our Chief Executive Officer, Rusty Rykoff. Rusty?
spk07: Thank you, Robert, and good morning, everyone. On today's call, we'll detail our first quarter financial results, all of which were outlined in our earnings press release issued this morning prior to this call. We'll also discuss ongoing commercial launch efforts and progress that we're making with Petmark in the U.S. and abroad following the exclusive licensing agreement announcement we executed in March with Norgene to commercialize Petmark's in Europe, Australia, and New Zealand. In the first quarter, Padmark delivered total net revenues of $25.4 million, including $18 million in licensing revenues from NorGene transaction and $7.4 million in net Padmark product sales. Robert will further elaborate on the $18 million in the licensing revenue related to the NorGene transaction, but to be clear, we received $43.2 million from the transaction, which is reflected in our balance sheet as of March 31st, and cash of $51.2 million. We believe that a couple of things affected Petmark sales during the first quarter of this year. First, the public reminder that the US FDA issued to healthcare professional organizations in January stating that PEDMARC is not substitutable without a sodium thiosulfate product, may have caused some unintended confusion in the marketplace. Initially, the professional affairs and stakeholder engagement staff at the FDA issued the potential health risks with substitution as a targeted outreach to the following organizations. Alliance for Pharmacy Compounding, American Academy of Pediatrics, American College of Apothecaries, American Hospital Association, American Pharmacists Association, American Society of Clinical Oncology, American Society of Health System Pharmacists, Association of American Cancer Institutes, Children's Hospital Association, Federation of American Hospitals, Hematology Oncology Pharmacy Association, International Academy of Compounding Pharmacists, and Professional Compounding Centers of America. We believe that, in turn, some of these organizations communicated the FDA's safety message to their respective members. Recently, the Office of New Drugs at the FDA added the safety communication issued by CDAR's Professional Affairs and Stakeholders Engagement staff to PEDMARC's approval at the FDA page. It is clear that substitution post-potential health risks, including potassium chloride exposure, which at high doses can lead to increased risk of acute cardiac events and other serious adverse reactions. Potassium chloride is not present in FEDMARC. Overexposure to boric acid. It can cause health risks including headache, hypothermia, restlessness, weariness, renal injury, dermatitis, alopecia, anorexia, and indigestion. Although Pedmark also contains boric acid, it is at a lower concentration than other STS products. Overexposure to sodium nitrate, which can lead to health risks, including methamoglobinemia. Sodium nitrate is co-packaged with sodium thiosulfate as a separate bile in some products, and it's not present in PedMart. Unfortunately, FENIX continues to see unlawful compounding of copies of PedMart with pediatric hospital pharmacies, unnecessarily putting costs in front of children's safety. The majority of these hospitals are affiliated with Children's Oncology Group, and thus far the FDA safety communication has not changed their behavior. PANEC continues to diligently work with the FDA to address this issue. Additionally, prior to April 1st of this year, our J-code did not differentiate between PEDMARC and other formulations of STS. As a consequence, which we discussed in our call last quarter, there had been some confusion and some impact to the adaptation of PEDMARC. The good news is that as of April 1st, this issue has been fully resolved with CMS amending our JCO to specify PEDMARC. Now that this change is effective, we expect uptake to improve in the quarters to follow. Despite these acute challenges, we remain optimistic that it will be an exciting year for FANUC given the strong performance with PEDMARC in 2023, the first full fiscal year following our U.S. commercial launch. We're confident in our ability to navigate through these marketplace challenges to achieve our long-term objectives. Our outlook over the next few quarters will largely depend on our ability to successfully target the community hospitals and infusion centers, the treat in the outpatient setting, all the pediatric patients within our label, and the NCCN guidelines for adolescents and young adults. Fedmark continues to have broad and favorable payer coverage as evidenced by payer approval, approved US prescription claims, with commercial insurance plans and Medicare Part D plans. Regarding our partnership with Norgene to commercialize PEDMARC-C in Europe, Australia, and New Zealand, efforts are well underway in these territories with a targeted launch date of fourth quarter this year. PEDMARC-C is the first and only approved therapy in the EU and UK for prevention of autotoxicity induced by cisplatin chemotherapy in patients one month to 18 years of age with localized non-metastatic solid tumors. As a reminder, under the terms of the licensing agreement, FANUC received approximately $43.2 million in upfront consideration and the potential of up to approximately $230 million in additional commercial and regulatory milestone payments and tiered royalties on net sales of FedMark C in the licensed territories up to the mid-20s. Norgene will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations. As we previously communicated, this partnership represents an important step in achieving our mission of expanding PEDMARC-C to patients across the globe who are at risk of suffering from cisplatin-induced autotoxicity. Their terms provided us with many important benefits, including an upfront payment for the solidifying our balance sheet, driving economic terms, providing With that, I will now turn the call over to Adrian, who will provide an update on our commercial strategy and operations.
spk03: Adrian? Thanks, Rosti. As Rosti has said, in the first quarter, our sales force has switched the focus of their activities to the community-treated AYA population that fall within our label. We believe that there are many more patients in this segment compared to the inpatient hospital-treated pediatric populations. Additionally, these older patients require approximately four times as much Pedmark as the younger patients. On our prior quarterly call, I alluded to the challenges that we faced during the early stages of our relaunch into this segment. Prior to April the 1st, 2024, our JCORD did not differentiate between Pedmark and other formulations of STS. Consequently, there has been some confusion and some impact on the adoption of PEDMARC. In January, CMS did two important things to address this matter. First, they issued a new J-code for the HUB-STS product, and second, they amended PhenX J-code to specify PEDMARC. Encouragingly, CMS also stated that the two formulations are not interchangeable. As a reminder, the new J-code specifying PEDMOC was not active until April 1st. It is also important to understand that the J-code becoming effective on April 1st is not a simple on-off event. It is taking some considerable time to get the code uploaded into the electronic prescribing systems and payment plans, and this task is still ongoing. Additionally, we are awaiting updates to the NCCM compendia and others, for example, Drugdex and Lexicon. These compendia are the proof source for payers to reimburse bedbark, and this process is expected to take 60 to 90 days to complete and validate from April 1st. Another ongoing challenge has been extending infusion centre hours to accommodate the time it takes to administer Pedmark six hours after the cisplatin infusion. Again, this doesn't happen overnight and requires the intervention of senior management at the infusion centre. We've had greater penetration in those centres that are open for 16 to 24 hours. Despite these acute challenges, we remain encouraged by the reaction to Pedmark, and the possibility to dramatically improve the quality of life for cancer survivors by preventing or significantly reducing hearing loss caused by cisplatin. We are confident that once these logistical hurdles are overcome, PEDMA will become the standard of care and be routinely used in the AYA population. We've had a very busy conference season with participation in 11 regional oncology conferences as well as seven key scientific meetings, including the American Society of Pediatric Haematology Oncology, the Community Oncology Alliance, the National Comprehensive Cancer Network, and the American Academy of Audiology annual conferences. And we're looking forward to ASCO, where we intend to spread the word to as many AYA treating physicians as possible. So in closing, we see promising opportunities for Pedmark, including the steps we're taking to educate the marketplace, along with executing on our commercialization plans. And we look forward to the acceleration in revenue in the coming months. With that, I'll turn the call over to Robert to go over the financials for the quarter.
spk05: Thank you, Adrian. Our press release contains details of our financial results for the first quarter of 2024. which can be viewed on the investors and media section of our website. Rather than read through all of those details as previous conference calls, my comments today will focus on some key financial results. The company recorded Pedmark net sales of $7.4 million for the first quarter of 2024. Net sales in the first quarter were more highly impacted than previous quarters by discounts, including an impact from select product that was returned due to expiry. The return product was due to production and launch dynamics in the first year after launch, which we don't anticipate to continue beyond the first quarter of 2024. Total net sales for the first quarter were $25.4 million, which, as mentioned, included $18 million for the accounting of licensing revenues for the Norgene transaction. The company evaluated the Norgene license agreement under ASC 606 and concluded that Norgene represents a customer in the transaction. As such, a portion of the transaction price was recognized as licensed revenue in the first quarter of 2024, and a portion of the transaction price associated with the material right is deferred and reflected as deferred revenue. To be clear, for the three months ended March 31st, 2024, the company did not recognize any milestone or royalty revenue payments from the Norgene transaction. G&A expenses for the first quarter of 2024 were 5.9 million, which compares to 4.3 million in the fourth quarter of 2023. This increase is largely attributable to pre-commercialization expenses in preparation for the potential European launch or partnership. The company recorded 5.2 million in selling and marketing expenses in the first quarter of 2024, compared to 2.5 million in the fourth quarter of 2023. The increase was largely attributable to higher payroll and increased marketing expenses related to the previously mentioned AYA initiatives. And finally, on our cash position, we ended the first quarter with approximately $51.2 million in cash, cash equivalents, and investment securities, which includes the approximately $43 million received from the licensing of Europe, Australia, and New Zealand to Norgene. Further, as a reminder, the next anticipated milestone related to our Norgene agreement will be obtaining pricing approval in Germany in which FENIC will receive a €10 million milestone payment. Further, FENIC's royalties on net sales will commence in the mid-teens percentages once PEDMARC-C is launched later in 2024. We anticipate that our cash, cash equivalents, and investment securities as of March 31, 2024, when coupled with PEDMARC revenue assumptions and the recently announced License Agreement for Europe, in March 24 will be sufficient to fund our planned operations for at least the next 12 months. And operated with that, we are ready for questions.
spk09: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star 1-1 again. We'll pause for a moment while we compile our Q&A roster.
spk01: Our first question comes from Charles Duncan with Cantor Fitzgerald.
spk09: Your line is open.
spk13: Yeah, good morning, Rosti and team. Thanks for taking the questions. And congrats on the progress in the quarter with the Norgene collaboration. Had a couple of questions, though, regarding the unlawful compounding. And you mentioned Children Oncology Group. I guess I'm wondering if you could provide some additional information color on the initiatives that you're taking to really correct this behavior. And then can you provide us any color on the level of compounding that you anticipate to occur in Europe versus here? Thanks.
spk07: Hi, Charles. I'll take this. Yeah, so as you saw from the FDA announcement, and then subsequently putting that announcement on the approval of Fedmark at the FDA page, the FDA is taking this issue very seriously. The problem that we run into at the pediatric hospital level is that they have a committee called the Expensive Drug Committee, and typically these committees are stacked with folks in the hospital that are not pediatric oncologists, or a pharmacist for that matter, but they're really there to do everything possible, but to avoid paying for an expensive drug, which they consider Pedmark to be one. So this is what we're facing. In terms of initiatives, What I would say is that we continue to work with the FDA on this. The FDA is very concerned. There is significant safety risk associated with the use of compounded products in this vulnerable population, particularly if you're pushing over 15 minutes to make a copy of Petmark, a very large and significant dose of potassium chloride in younger children. So with that, I think our engagement with the FDA is ongoing, and if there's anything more to report, we will hopefully soon. In terms of Europe, what I would say is there's a bit of a difference because there you're dealing with, so we have a pediatric use marketing authorization, which by definition gives exclusivity to the market on the data of the studies, from the studies, to, in this case now, Norgene. How is that different in the United States is that you're not dealing by hospital by hospital basis. You're dealing with a healthcare system and regulations that have already been approved for the use of an older drug in a pediatric population with a 10-year exclusivity. So that's well understood that you're bringing in tremendous value to this vulnerable population because you've invested in these studies and you have this 10-year exclusivity. And so you're also dealing with a single payer system. So there it's really the negotiations that will be ongoing between Norgene and each respective country in terms of the price achieved. But once that happens, this drug would be available and approved by a single payer. So there should not be a significant issue with compounding in Europe. And maybe I can turn it over to Adrian to elaborate on that as well.
spk03: Yeah, thanks, Rosti. It's exactly, as you said, we have the Pediatric Use Marketing Authorization, which is specifically designed for older products repurposed for children. And once there's an approved drug, in most of the European markets, compounding is illegal. As you can imagine, there was a lot of diligence done by the parties that were bidding for the European rights. And all of them came to the conclusion, obviously, including Norgene, be an issue in Europe.
spk13: That makes sense. One quick follow-up then for you, Adrian or Rosti, with regard to the J-code, nice to see that happen in April and appreciate all the caveat with regard to the timing of that going from effective to actually effective. But when you think about either the second quarter or the second half of this year, How would you measure success beyond the obvious of revenue? What are the key operating metrics that you're looking at to see that PEDMARC's getting traction in the AYA population? Thanks.
spk07: Great question, Charles. So let me kind of maybe tell you how I look at the business holistically. So we got several components to this. One is our medical education. So how well do we engage and educate the staff at a community center that historically has not treated for auto toxicity? So I think that's very, very critical. The second component is market access. And I think Adrian alluded to that in his comments. That's the payer coverage, which so far we haven't had any significant issues with. The Compendia update, which is really important. Then we have to deal with field reimbursement and ultimately pull through. And these are all ongoing activities. Then we have the logistics and distribution piece where we are working with the office, but importantly, we must listen to these offices to make sure we can provide bed marks despite the six-hour gap between the cisplatin therapy and when bed mark is administered. And lastly, I think it's just establishing best practices and really learning from the experiences. It is very important that we get it right. So basically, I look at this as sort of a mini-pilot at the moment, what we learn from that, and how do we then scale it. And this goes back to the on and off switch that Adrian referred to. It's like, let's get this thing right now so that when it scales, we know how to exactly do this. And then we can expect, obviously, a meaningful inflection point when all the barriers are sort of removed and we've learned how to navigate through this. So I hope this is helpful.
spk13: Would that increased visibility occur in the second half of this year, you anticipate, Rossi?
spk07: That would be my anticipation, correct.
spk03: Yeah, as I said, I think it's taking between 60 to 90 days to get everything loaded up into the electronic prescribing systems to get the compendia updated just doesn't happen overnight. And once that's done, then we expect to see the inflection point. So I think you're right, second half of the year.
spk13: Got it. Thanks for taking the questions.
spk09: One moment for our next question. Our next question comes from Chase Knickerbock with Craig Hellam. Your line is open.
spk02: Good morning, guys. Thanks for taking the questions. So just maybe dig in a little bit on the inpatient side quickly. I understand the difficulty in signing up new customers, certainly on the inpatient side, if those potential customers are compounding. But if we just kind of look at existing customers in Q4, what drove utilization there down sequentially? At least that's kind of what it looks like on the top line number, maybe just a little bit of color around existing customer utilization.
spk07: Yeah, let me take this. So I would say there are a couple of things. One is that Robert touched on the bed debt expense, and he can elaborate further on that. And then the second piece, of course, is, I mean, I can just tell you that the difference between our fourth quarter and first quarter sales without the bed debt expense is basically three to five patients. And also historically, Chase, just to also add a little more color, we, you know, if you look at kind of last year as well, maybe there's some seasonality to this as well. We had a stronger fourth quarter than we did first quarter. But it's too early to tell. Yeah.
spk03: I would just add, Chase, that, you know, as Rusty mentioned, The FDA publishing the do not substitute guidance on the website, on the PEDMARC label side of the website, seems to have had an impact. We've had a couple of really important pediatric hospitals just in the last week have ordered for the first time. So that's an encouraging trend. It's early days. But I think FDA publishing on the website But up until then, it really hasn't.
spk07: Right, because the confusion came from we're getting this message communicated from these organizations instead of what is the FDA really saying to now look at what the FDA is really saying. But again, this is very early. We're dealing with a very challenging, challenged hospital system. with these expensive drug committees. So I want to make sure that we sort of tame expectations on this. And as we're getting some of them to switch, obviously that will be welcome news. But we have not, obviously we have been very, very patient with everyone and we're working with the FDA to resolve all of this. I think at one point it would happen, Chase. I just don't know when.
spk02: Understood. And then, Robert, maybe can you just quantify what that return was as far as a headwind to top line revenue? Sorry. And then just to kind of dig in a little bit on those comments, you have seen some change in behavior in Q2, but really hasn't been material to revenue yet, but early signs of behavior are changing. Is that kind of the right way to characterize it? Correct.
spk01: With a couple of larger accounts.
spk05: Yeah, I'll start with your question, Chase, as well. Just from a framework perspective, in Q4, we had gross sales of a little over 11 million and reported net sales of 9.7. In Q1, we had gross sales of 9.7 million and reported net sales of 7.4. So that delta of And that jump up in percentage was, as I mentioned, largely as a result of product that due to expiry, we had to give a credit to some distributors in the quarter.
spk02: Got it. Thank you. And then maybe just trends in AYA, digging in a little bit more there. It sounds like Q3 should kind of be our expectation of when that accelerates and really kind of inflects in the model. And, you know, biggest driver there, it probably is going to take some more time to obviously get those clinics to stay open. So is the biggest driver kind of that compendium ad or just going to walk us through what the, you know, big kind of unlock on the inflection is there?
spk07: I would say it's all of the above that I listed in the previous question. It's really getting the medical education. I cannot stress the importance of that, to be honest, because we have people that want to listen to our message. It's important how well the message is delivered, how well we're engaging. Because remember, these physicians are not treating for autotoxicity. They haven't treated historically because these are centers that are treating basically with chemo drugs the patients. So that's one that's ongoing. And obviously, we're refining our strategy there. We're learning from them, et cetera. So that engagement piece is critical. Then once they want to work with us, it's obviously all the logistics involved. The market access, making sure that all these pieces are together. Compendia is a very important piece from that as well. There's also will be fuel reimbursement pulled through. A bunch of things that we kind of, and we have seen actually in a few patients. Again, the sample size is relatively small. So we want to make sure that we have a larger sample size. As I mentioned, these are kind of like mini pilots. At least in my mind, because one thing we learned in this company historically, which worked for us well, is when we simplify things and we get it down to like the very, very basics. And the very basics here are you treating one patient at a time truly? And is that a success for the patient, for the center, and ultimately for FANUC? Can you create this win-win-win? And all these components are really critical to that. And we're working through those. And I think there will be an inflection point because when you look at the number of volume of patients these centers are seeing, it's actually quite encouraging that those numbers are substantially higher than what we discussed with pediatrics. So this is really the opportunity ahead of us. And then how do we accelerate it once we've established these best practices? How do we accelerate that through this network?
spk02: And then just last for me, maybe Adrian, what you're hearing from the field around kind of willingness of these clinics to stay open longer. Are you getting some pushback there or is it mainly just kind of working with the administration takes time to kind of change protocols there?
spk03: Yeah, we're getting pushback when you speak to the people in the clinic because they don't have the authority to stay up longer. So you've got to work your way up through the senior management to find the decision maker and then explain things to them. And it just is taking a longer time than initially anticipated. But it's, you know, it's happening. And in the meantime, as I said in the prepared remarks, we've kind of, we're searching for the centers that are open sort of 12 hours plus, because then there's no issues. And that's where we're really seeing uptake now.
spk12: Thanks for the questions, guys.
spk07: Yeah, yeah, no, the other component to this, and I just want to, and this is, again, credit to the team and how resourceful they are. We also have a relationship with a home infusion network that is able to provide the infusion of Fedmark to the patient at home. And so we're just starting to utilize that, which is, to me, is also encouraging because, again, we're providing basically a suite of services. We're problem-solving for a lot of places. And so there's initiatives ongoing there as well. But as Adrian mentioned, this takes a bit of time to work through all of this.
spk01: Thank you. One moment for our next question. Our next question comes from Jason McCarthy with Maxim Group.
spk09: Your line is open.
spk15: Hey there. Thank you for taking my question. This is Michael Okunowich on the line for Jason. I guess I'd like to see if you could give me a bit more color on how the value proposition varies between the under 15s and the adolescent young adult population. And then given that they do require more vials on average, is this something where you'd have to or where you'd expect you'd need additional discounts to adequately capture this larger market?
spk07: Yeah, it's a very good question. So let me just sort of compare for you a disease which starts occurring from the age of 15 all the way to the age of 39, which is germ cell testicular cancer. So largely, how you treat the 15-year-old is the same as how you treat the adolescent, the young adult and the adolescent. as well as the older patient. What changes there, of course, is the body surface area and our drug is administered based on that. So typically you have, and also there's a decision making there, whether they go with the three cycles or the five cycles, which also could vary. But bottom line is kind of when you compare it to the typical sort of pediatric patient versus you, older patient you have a uh you know three to four times more vials uh again just to just to get a flavor for that so uh so when i truly mentioned the difference between the fourth quarter versus the first quarter numbers it's uh it's really a difference of uh of that three to five patients And now in terms of giving discounts, so now recall that you're dealing with the outpatient community where a meaningful discount is not really necessary because they have mechanisms in place by which they get to make over 5% for this on the upfront. And of course, if you... There's also some volume discounts available to them as well, but they're not meaningful relative to the opportunity to treat these patients. And again, these patients are reimbursed based on the NCCN type 2a recommendation.
spk15: All right, thank you. And then as a follow-up, I just want to do a quick housekeeping question. With the EU partnered out now, should we expect that GNA line to start to come in a little bit in subsequent quarters?
spk06: And maybe that's over to you, Robert.
spk05: Yeah, thanks, Michael. Yes, that is the expectation after this quarter being Q2 that we're in. It should come in significantly. So we did see a step up quite a bit in Q1, also some in Q4, and it's just tailing off here in Q2. But then, yes, that's all being assumed by NorGene going forward.
spk14: All right. Thank you very much.
spk09: One moment for our next question. Our next question comes from with AC Rainright. Your line is open.
spk10: Thanks very much for taking my questions. Just two very quick ones. Can you just give us a sense of what the repercussions would be, if any, for those hospitals and hospital systems that deliberately do not elect to follow the FDA's guidance? And secondly, if you can maybe elaborate upon the level of sales and marketing infrastructure that Norgene has communicated to you will be placed in the service of commercializing Pegmarxie in its territory.
spk07: Thank you. Thank you. These are great questions. So the repercussions really are it's really are they causing harm and what that harm is and ultimately the parents filing a suit against the hospital for their child being treated with an unauthorized copy of a FDA-approved drug, which clearly states on its label, do not substitute. And now there is a public message announcement as to why it's not a good idea to substitute. In terms of Fennec, legal repercussions. We're exploring all these options, but as you know, typically in business, it's not a best practice to go after your customers. So again, we have been very, very patient and we're working through the FDA with that. On the NordGene transaction, maybe Adrian can elaborate a little more in terms of their commitment to FedMark and how important that is in Europe in particular.
spk03: Yes, it's one of the reasons why we picked Norgene in that they promised and have committed to resource the launch appropriately. And what we understand is that it's north of 50 FTEs. and what I consider to be a very appropriate level of spend in terms of promotional results. So it's much, much more firepower than Fennec could ever have done on our own. So I'm confident things are going to go off very well. And as a reminder, the launch is scheduled in Germany for October.
spk09: Thank you. I'm not showing any further questions at this time. I'd like to turn the call back over to Rosti for any closing remarks.
spk07: Thank you all for today, and we look forward to updating everyone on our progress this quarter and beyond. But thank you for your patience with us, and stay tuned. We're working very hard to get this right. Thank you.
spk09: Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day. Thank you. you Thank you. Thank you. Bye. Bye. music music you Good morning, ladies and gentlemen, and welcome to the Fennec Pharmaceuticals first quarter 2020 for earnings and corporate update conference call. At this time, all participants are on 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 Fennec Fennec's Chief Financial Officer, Robert Andrade, please go ahead.
spk05: Thank you, operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceuticals' first quarter 2024 earnings conference call, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning are Rusty Rykov, our Chief Executive Officer, and Adrian Hay our Chief Operating Officer. 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 United States 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. With that, I will now turn the call over to our Chief Executive Officer, Rusty Rykoff. Rusty?
spk07: Thank you, Robert, and good morning, everyone. On today's call, we'll detail our first quarter financial results, all of which were outlined in our earnings press release issued this morning prior to this call. We'll also discuss ongoing commercial launch efforts and progress they were making with Padmark in the US and abroad following the exclusive licensing agreement announcement we executed in March with Norgene to commercialize Padmarks in Europe, Australia, and New Zealand. In the first quarter, Padmark delivered total net revenues of $25.4 million, including $18 million in licensing revenues from Norgene transaction and $7.4 million in net Padmark product sales. Robert will further elaborate on the $18 million in the licensing revenue related to the Norwegian transaction, but to be clear, we received $43.2 million from the transaction, which is reflected on our balance sheet as of March 31st, and cash of $51.2 million. We believe that a couple of things affected Petmark sales during the first quarter of this year. First, the public reminder that the U.S. FDA issued to healthcare professional organizations in January stating that PEDMARC is not substitutable without a sodium thiosulfate product may have caused some unintended confusion in the marketplace. Initially, the professional affairs and stakeholder engagement staff at the FDA issued the potential health risks with substitution as a targeted outreach to the following organizations. Alliance for Pharmacy Compounding, American Academy of Pediatrics, American College of Apothecaries, American Hospital Association, American Pharmacists Association, American Society of Clinical Oncology, American Society of Health System Pharmacists, Association of American Cancer Institutes, Children's Hospital Association, Federation of American Hospitals, Hematology Oncology Pharmacy Association, International Academy of Compounding Pharmacists, and Professional Compounding Centers of America. We believe that, in turn, some of these organizations communicated the FDA's safety message to their respective members. Recently, the Office of New Drugs at the FDA added the safety communication issued by CDAR's Professional Affairs and Stakeholders Engagement staff to PEDMARC's approval at the FDA page. It is clear that substitution post-potential health risks, including potassium chloride exposure, which at high doses can lead to increased risk of acute cardiac events and other serious adverse reactions. Potassium chloride is not present in PET marks. Overexposure to boric acid. It can cause health risks including headache, hypothermia, restlessness, weariness, renal injury, dermatitis, alopecia, anorexia, and indigestion. Although Pedmark also contains boric acid, it is at a lower concentration than other STS products. Overexposure to sodium nitrate, which can lead to health risks, including methamoglobinemia. Sodium nitrate is co-packaged with sodium thiosulfate as a separate bio in some products, and it's not present in PedMart. Unfortunately, Fenex continues to see unlawful compounding of copies of PedMart with pediatric hospital pharmacies, unnecessarily putting costs in front of children's safety. The majority of these hospitals are affiliated with Children's Oncology Group, and thus far, the FDA safety communication has not changed their behavior. PENF continues to diligently work with the FDA to address this issue. Additionally, prior to April 1st of this year, our J-code did not differentiate between PEDMARC and other formulations of STS. As a consequence, which we discussed in our call last quarter, there had been some confusion and some impact to the adaptation of PEDMARC. The good news is that as of April 1st, this issue has been fully resolved with CMS amending our JCO to specify Padmark. Now that this change is effective, we expect uptake to improve in the quarters to follow. Despite these acute challenges, we remain optimistic that it will be an exciting year for FANUC given the strong performance with Padmark in 2023, the first full fiscal year following our U.S. commercial launch. We're confident in our ability to navigate through these marketplace challenges to achieve our long-term objectives. Our outlook over the next few quarters will largely depend on our ability to successfully target the community hospitals and infusion centers that treat in the outpatient setting all the pediatric patients within our label and the NCCM guidelines for adolescents and young adults. Fedmark continues to have broad and favorable payer coverage as evidenced by payer-approved U.S. prescription claims with commercial insurance plans and Medicare Part D plans. Regarding our partnership with Norgene to commercialize PEDMARC-C in Europe, Australia, and New Zealand, efforts are well underway in these territories with a targeted launch date of fourth quarter this year. PEDMARC-C is the first and only approved therapy in the EU and UK for prevention of autotoxicity induced by cisplatin chemotherapy in patients one month to 18 years of age with localized non-metastatic solid tumors. As a reminder, under the terms of the licensing agreement, FANUC received approximately $43.2 million in upfront consideration and the potential of up to approximately $230 million in additional commercial and regulatory milestone payments and tiered royalties on net sales of FedMark C in the licensed territories up to the mid-20s. Norgene will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations. As we previously communicated, this partnership represents an important step in achieving our mission of expanding PEDMARC-C to patients across the globe who are at risk of suffering from cisplatin-induced autotoxicity. Their terms provided us with many important benefits, including an upfront payment for the solidifying our balance sheet, driving economic terms, providing meaningful participation in the ex-US success of PEDMARC-C, With that, I will now turn the call over to Adrian, who will provide an update on our commercial strategy and operations. Adrian?
spk03: Thanks, Rosti. As Rosti has said, in the first quarter, our sales force has switched the focus of their activities to the community-treated AYA population that fall within our label. We believe that there are many more patients in this segment compared to the inpatient hospital-treated pediatric populations. Additionally, these older patients require approximately four times as much Pedmark as the younger patients. On our prior quarterly call, I alluded to the challenges that we faced during the early stages of our relaunch into this segment. Prior to April the 1st, 2024, our JCORD did not differentiate between Pedmark and other formulations of STS. Consequently, there has been some confusion and some impact on the adoption of PEDMARC. In January, CMS did two important things to address this matter. First, they issued a new J-code for the Hope STS product, and second, they amended PhenX J-code to specify PEDMARC. Encouragingly, CMS also stated that the two formulations are not interchangeable. As a reminder, the new J-code specifying PEDMOC was not active until April 1st. It is also important to understand that the J-code becoming effective on April 1st is not a simple on-off event. It is taking some considerable time to get the code uploaded into the electronic prescribing systems and payment plans, and this task is still ongoing. Additionally, we are awaiting updates to the NCCM compendia and others, for example, Drugdex and Lexicon. These compendia are the proof source for payers to reimburse bedbark, and this process is expected to take 60 to 90 days to complete and validate from April 1st. Another ongoing challenge has been extending infusion centre hours to accommodate the time it takes to administer PEDMARC six hours after the cisplatin infusion. Again, this doesn't happen overnight and requires the intervention of senior management at the infusion centre. We've had greater penetration in those centres that are open for 16 to 24 hours. Despite these acute challenges, we remain encouraged by the reaction to PEDMARC and the possibility to dramatically improve the quality of life for cancer survivors by preventing or significantly reducing hearing loss caused by cisplatin. We are confident that once these logistical hurdles are overcome, PEDMA will become the standard of care and be routinely used in the AYA population. We've had a very busy conference season with participation in 11 regional oncology conferences as well as seven key scientific meetings, including the American Society of Pediatric Haematology Oncology, the Community Oncology Alliance, the National Comprehensive Cancer Network, and the American Academy of Audiology annual conferences. And we're looking forward to ASCO, where we intend to spread the word to as many AYA treating physicians as possible. So in closing, we see promising opportunities for Pedmark, including the steps we're taking to educate the marketplace, along with executing on our commercialization plans. And we look forward to the acceleration in revenue in the coming months. With that, I'll turn the call over to Robert to go over the financials for the quarter.
spk05: Thank you, Adrian. Our press release contains details of our financial results for the first quarter of 2024. which can be viewed on the investors and media section of our website. Rather than read through all of those details as previous conference calls, my comments today will focus on some key financial results. The company recorded Pedmark net sales of $7.4 million for the first quarter of 2024. Net sales in the first quarter were more highly impacted than previous quarters by discounts, including an impact from select product that was returned due to expiry. The return product was due to production and launch dynamics in the first year after launch, which we don't anticipate to continue beyond the first quarter of 2024. Total net sales for the first quarter were $25.4 million, which as mentioned included $18 million for the accounting of licensing revenues for the Norgene transaction. The company evaluated the Norgene license agreement under ASC 606 and concluded that Norgene represents a customer in the transaction. As such, a portion of the transaction price was recognized as licensed revenue in the first quarter of 2024, and a portion of the transaction price associated with the material right is deferred and reflected as deferred revenue. To be clear, for the three months ended March 31st, 2024, the company did not recognize any milestone or royalty revenue payments from the Norgene transaction. G&A expenses for the first quarter of 2024 were 5.9 million, which compares to 4.3 million in the fourth quarter of 2023. This increase is largely attributable to pre-commercialization expenses in preparation for the potential European launch or partnership. The company recorded 5.2 million in selling and marketing expenses in the first quarter of 2024, compared to 2.5 million in the fourth quarter of 2023. The increase was largely attributable to higher payroll and increased marketing expenses related to the previously mentioned AYA initiatives. And finally, on our cash position, we ended the first quarter with approximately $51.2 million in cash, cash equivalents, and investment securities, which includes the approximately $43 million received from the licensing of Europe, Australia, and New Zealand to Norgene. Further, as a reminder, the next anticipated milestone related to our Norgene agreement will be obtaining pricing approval in Germany in which FENIC will receive a 10 million euro milestone payment. Further, FENIC's royalties on net sales will commence in the mid-teens percentages once PEDMARC-C is launched later in 2024. We anticipate that our cash, cash equivalents, and investment securities as of March 31, 2024, when coupled with PEDMARC revenue assumptions and the recently announced license agreement for Europe, in March 24 will be sufficient to fund our planned operations for at least the next 12 months. And operated with that, we are ready for questions.
spk09: Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 1-1 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press star 1-1 again. We'll pause for a moment while we compile our Q&A roster.
spk01: Our first question comes from Charles Duncan with Cantor Fitzgerald.
spk09: Your line is open.
spk13: Yeah. Good morning, Rosti and team. Thanks for taking the questions. And congrats on the progress in the quarter with the Norgene collaboration. Had a couple of questions, though, regarding the unlawful compounding. And you mentioned Children Oncology Group. I guess I'm wondering if you could provide some additional information color on the initiatives that you're taking to really correct this behavior, and then can you provide us any color on the level of compounding that you anticipate to occur in Europe versus here? Thanks.
spk07: Hi, Charles. I'll take this. Yeah, so as you saw from the FDA announcement, and then subsequently putting that announcement on the approval of Fedmark at the FDA page, the FDA is taking this issue very seriously. The problem that we run into at the pediatric hospital level is that they have a committee called the Expensive Drug Committee, and typically these committees are stacked with folks in the hospital that are not pediatric oncologists, or a pharmacist for that matter, but they're really there to do everything possible, but to avoid paying for an expensive drug, which they consider Pedmark to be one. So this is what we're facing. In terms of initiatives, What I would say is that we continue to work with the FDA on this. The FDA is very concerned. There is significant safety risk associated with the use of compounded products in this vulnerable population, particularly if you're pushing over 15 minutes to make a copy of Petmark, a very large and significant dose of potassium chloride in younger children. So with that, I think our engagement with the FDA is ongoing and if there's anything more to report, we will hopefully soon. In terms of Europe, what I would say is there's a bit of a difference because there you're dealing with, so we have a pediatric use marketing authorization, which by definition gives exclusivity to the market on the data of the studies, from the studies, to, in this case now, Norgene. How is that different in the United States is that you're not dealing by hospital by hospital basis. You're dealing with a healthcare system and regulations that have already been approved for the use of an older drug in a pediatric population with a 10-year exclusivity. So that's well understood that you're bringing in tremendous value to this vulnerable population because you've invested in these studies and you have this 10-year exclusivity. And so you're also dealing with a single payer system. So there it's really the negotiations that will be ongoing between Norgene and each respective country in terms of the price achieved. But once that happens, this drug would be available and approved by a single payer. So there should not be a significant issue with compounding in Europe. And maybe I can turn it over to Adrian to elaborate on that as well.
spk03: Yeah, thanks, Rosti. It's exactly, as you said, we have the Pediatric Views Marketing Authorization, which is specifically designed for older products repurposed for children. And once there's an approved drug, in most of the European markets, compounding is illegal. As you can imagine, there was a lot of diligence done by the parties that were bidding for the European rights. And all of them came to the conclusion, obviously, including Norgene, be an issue in Europe.
spk13: That makes sense. One quick follow-up then for you, Adrian, or Rosti, with regard to the J-code, nice to see that happen in April and appreciate all the caveat with regard to the timing of that going from effective to actually effective. But when you think about either the second quarter or the second half of this year as How would you measure success beyond the obvious of revenue? What are the key operating metrics that you're looking at to see that PEDMARC's getting traction in the AYA population? Thanks.
spk07: Great question, Charles. So let me kind of maybe tell you how I look at the business holistically. So we got several components to this. One is our medical education. So how well do we engage and educate the staff at a community center that historically has not treated for auto toxicity? So I think that's very, very critical. The second component is market access. And I think Adrian alluded to that in his comments. That's the payer coverage, which so far we haven't had any significant issues with. The Compendia update, which is really important. Then we have to deal with field reimbursement and ultimately pull through. And these are all ongoing activities. Then we have the logistics and distribution piece where we are working with the office, but importantly, we must listen to these offices to make sure we can provide bed marks despite the six-hour gap between the cisplatin therapy and when bed marks are administered. And lastly, I think it's just establishing best practices and really learning from the experiences. It is very important that we get it right. So basically I look at this as sort of a mini pilot at the moment, what we learn from that and how do we then scale it. And so, and this goes back to the on and off switch that Adrian referred to. It's like, let's get this thing right now so that when it scales, we know how to exactly do this. So, and then we can expect obviously a meaningful inflection point when all the barriers are sort of removed and we've learned how to navigate through this. So I hope this is helpful.
spk13: Would that increased visibility occur in the second half of this year, you anticipate, Rossi?
spk07: That would be my anticipation, correct.
spk03: Yeah, as I said, I think it's taking between 60 to 90 days to get everything sort of loaded up into the electronic prescribing systems to get the compendia updated just doesn't happen overnight. And once that's done, then we expect to see the inflection point. So I think you're right, second half of the year.
spk13: Got it. Thanks for taking the questions.
spk09: One moment for our next question. Our next question comes from Chase Knickerbock with Craig Hallam. Your line is open.
spk02: Morning, guys. Thanks for taking the questions. So just maybe dig in a little bit on the inpatient side quickly. I understand the difficulty in signing up new customers, certainly on the inpatient side, if those potential customers are compounding. But if we just kind of look at existing customers in Q4, what drove utilization there down sequentially? At least that's kind of what it looks like on the top line number, maybe just a little bit of color around existing customer utilizations.
spk07: Yeah, let me take this. So I would say there are a couple of things. One is that Robert touched on the bed-debt expense, and he can elaborate further on that. And then the second piece, of course, is, I mean, I can just tell you that the difference between our fourth quarter and first quarter sales without the bed-debt expense is basically three to five patients. And also historically, Chase, just to also add a little more color, if you look at last year as well, maybe there's some seasonality to this as well. We had a stronger fourth quarter than we did first quarter. But it's too early to tell. Got it. And maybe Rob.
spk03: I would just add, Chase, that as Rusty mentioned earlier, The FDA publishing the do not substitute guidance on the website, on the Pedmark label side of the website, seems to have had an impact. We've had a couple of really important pediatric hospitals just in the last week have ordered for the first time. So that's an encouraging trend. It's early days. But I think FDA publishing on the website But up until then, it really hadn't.
spk07: Right, because the confusion came from we're getting this message communicated from these organizations instead of what is the FDA really saying to now look at what the FDA is really saying. But again, this is very early. We're dealing with a very challenging, challenged hospital system. with these expensive drug committees. So I want to make sure that we sort of tame expectations on this. And as we're getting some of them to switch, obviously that will be welcome news. But we have not, obviously we have been very, very patient with everyone and we're working with the FDA to resolve all of this. I think at one point it would happen, Chase. I just don't know when.
spk02: Understood. And then, Robert, maybe can you just quantify what that return was as far as a headwind to top line revenue? Sorry. And then just to kind of dig in a little bit on those comments, you have seen some change in behavior in Q2, but really hasn't been material to revenue yet, but early signs of behavior are changing. Is that kind of the right way to characterize it? Correct.
spk01: With a couple of larger accounts.
spk05: Yeah, I'll start with your question, Chase, as well. Just from a framework perspective, in Q4, we had gross sales of a little over 11 million and reported net sales of 9.7. In Q1, we had gross sales of 9.7 million and reported net sales of 7.4. So that delta of And that jump up in percentage was, as I mentioned, largely as a result of product that due to expiry, we had to give a credit to some distributors in the quarter.
spk02: Got it. Thank you. And then maybe just trends in AYA, digging in a little bit more there. It sounds like Q3 should kind of be our expectation of when that accelerates and really kind of inflects in the model. And, you know, biggest driver there, it probably is going to take some more time to obviously get those clinics to stay open. So is the biggest driver kind of that compendium ad or just kind of walk us through what the, you know, big kind of unlock on the inflection is there?
spk07: Yeah, I mean, I would say it's all of the above that I listed in the previous question. It's really important. you know, getting the medical education. I cannot stress the importance of that, to be honest, because we've got a, we have people that want to listen to our message. It's important how well the message is delivered, how well we're engaging. Just remember these physicians are not treating for autotoxicity. They haven't treated historically because these are centers that are treating basically the chemo drugs, the patients. So that's one. that's ongoing and obviously we're refining our strategy there, we're learning from them, etc. So that engagement piece is critical. Then once they want to work with us, it's obviously all the logistics, the market access, making sure that all these pieces are together. Compendia is a very important piece from that as well. There's also will be fuel reimbursement, pull-through, a bunch of things that we kind of, and we have seen actually in a few patients, again, the sample size is relatively small. So we want to make sure that we have a larger sample size. As I mentioned, these are kind of like mini pilots, at least in my mind, because one thing we learned in this company historically, what's worked for us well, is when we simplify things and we get it down to like the very, very basics. And the very basics here are you treating one patient at a time truly? And is that a success for the patient, for the center, and ultimately for FANUC. Can you create this win-win-win? And all these components are really critical to that. And we're working through those. And I think there will be an inflection point because when you look at the number of volume of patients that these centers are seeing, it's actually quite encouraging that those numbers are substantially higher than what we've discussed with pediatrics. So this is really the opportunity ahead of us. And then how do we accelerate it once we've established these best practices? How do we accelerate that through this network?
spk02: And then just last for me, maybe Adrian, what you're hearing from the field around kind of willingness of these clinics to stay open longer. Are you getting some pushback there or is it mainly just kind of working with the administration takes time to kind of change protocols there?
spk03: Yeah, we're getting pushback when you speak to the people in the clinic because they don't have the authority to stay up longer. So you've got to work your way up through the senior management to find the decision maker and then explain things to them. And it just is taking a longer time than initially anticipated. But it's, you know, it's happening. And in the meantime, as I said in the prepared remarks, we've kind of, we're searching for the centers that are open sort of 12 hours plus, because then there's no issues. And that's where we're really seeing uptake now.
spk12: Thanks for the question, guys.
spk07: Yeah, no, the other component to this, and I just want to, and this is, again, credit to the team and how resourceful they are. We also have a relationship with a home infusion network that is able to provide the infusion of Fedmark to the patient at home. And so we're just starting to utilize that, which is, to me, is also encouraging because, again, we're providing basically a suite of services. We're problem-solving for a lot of places. And so there's initiatives ongoing there as well. But as Adrian mentioned, this takes a bit of time to work through all of this.
spk01: Thank you. One moment for our next question. Our next question comes from Jason McCarthy with Maxim Group.
spk09: Your line is open.
spk15: Hey there. Thank you for taking my question. This is Michael Okunowich on the line for Jason. I guess I'd like to see if you could give me a bit more color on how the value proposition varies between the under 15s and the adolescent young adult population. And then given that they do require more vials on average, is this something where you'd have to or where you'd expect you'd need additional discounts to adequately capture this larger market?
spk07: Yeah, it's a very good question. So let me just sort of compare for you a disease which starts occurring from the age of 15 all the way to the age of 39, which is germ cell testicular cancer. So largely, how you treat the 15-year-old is the same as how you treat the adolescent, the young adult and the adolescent. as well as the older patient. What changes there, of course, is the body surface area and our drug is administered based on that. So typically you have, and also there's a decision making there, whether they go with the three cycles or the five cycles, which also could vary. But bottom line is kind of when you compare it to the typical sort of pediatric patient versus or older patient, you have three to four times more vials. Again, just to get a flavor for that. So when I truly mentioned the difference between the fourth quarter versus the first quarter numbers, it's really a difference of that three to five patients. Now, in terms of giving discounts, so now recall that you're dealing with the outpatient community where a meaningful discount is not really necessary because they have mechanisms in they get to make over 5% for this on the upfront. And of course, there's also some volume discounts available to them as well, but they're not meaningful relative to the opportunity to treat these patients. And again, these patients are reimbursed based on the NCCN type 2a recommendation.
spk15: All right, thank you. And then as a follow-up, I just want to do a quick housekeeping question. With the EU partnered out now, should we expect that GNA line to start to come in a little bit in subsequent quarters?
spk06: Yeah, maybe that's over to you, Robert.
spk05: Yeah, thanks, Michael. Yes, that is the expectation after this quarter being Q2 that we're in. It should come in significantly. So we did see a step up. quite a bit in Q1, also some in Q4, and it's just tailing off here in Q2. But then, yes, that's all being assumed by Norgene going forward.
spk14: All right. Thank you very much.
spk09: One moment for our next question. Our next question comes from with AC Rainwright. Your line is open.
spk10: Thanks so much for taking my questions. Just two very quick ones. Firstly, can you just give us a sense of what the repercussions would be, if any, for those hospitals and hospital systems that deliberately do not elect to follow the FDA's guidance? And secondly, if you can maybe elaborate upon the level of sales and marketing infrastructure that Norgene has communicated to you will be placed in the service of commercializing Pegmarxie in its territories.
spk07: Thank you. Thank you. These are great questions. So the repercussions really are, it's really, are they causing harm and what that harm is? And ultimately, the parents filing a suit against the hospital for their child being treated with an unauthorized copy of a FDA-approved drug, which clearly states on its label, do not substitute. And now there is a public message announcement as to why it's not a good idea to substitute. In terms of Fennec, repercussions legal repercussions we're exploring all these options but as you know typically in business is not a it's not a best practice to to go after your your customers so again we have been very very patient and working through the FDA with that On the NorGene transaction, maybe Adrian can elaborate a little more in terms of their commitment to PEDMARC and how important that is for them in Europe in particular.
spk03: Yes, it's one of the reasons why we picked Norgene in that they promised and have committed to resource the launch appropriately. And what we understand is that it's north of 50 FTEs and what I consider to be a very appropriate level of spend in terms of promotional resources. So it's much, much more firepower than Fennec could ever have done on our own. So I'm confident things are going to go off very well. And as a reminder, the launch is scheduled in Germany for October.
spk09: Thank you. I'm not showing any further questions at this time. I'd like to turn the call back over to Rosti for any closing remarks.
spk07: Thank you all for for today and we look forward to updating everyone on our progress uh this quarter and beyond but thank you for your patience with us and stay tuned we are we're working very hard to get this right thank you ladies and gentlemen let's conclude today's presentation you may now disconnect and have a wonderful day
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