Q2 2025 Fennec Pharmaceuticals Inc Earnings Call

Operator: Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals' second quarter 2025 earnings and corporate update conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions on how to participate will be given at that time. As a reminder, today's conference is being recorded. Now, I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade.

Speaker #2: Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals' second quarter 2025 earnings and corporate update conference call. At this time, all participants are in a listen-only mode.

Speaker #2: Later, we will conduct a question-and-answer session and instructions on how to participate will be given at that time. As a reminder, today's conference is being recorded.

Speaker #2: Now, I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade.

Robert Andrade: Thank you, Operator, and good morning, everyone. Thank you for joining us. We are pleased to host Fennec Pharmaceuticals' second quarter 2025 earnings conference call today, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning is our Chief Executive Officer and Board Member, Jeff Hackman. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. Reference to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission.

Speaker #3: Thank you, Operator. And good morning, everyone. Thank you for joining us. We are pleased to host Fennec Pharmaceuticals' second quarter 2025 earnings conference call today.

Speaker #3: During which, we will review our financial results, as well as provide a general business update. Joining me from Fennec this morning is our Chief Executive Officer, and board member, Jeff Hackman.

Speaker #3: 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.

Speaker #3: 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 US Securities and Exchange Commission.

Robert Andrade: In addition, any forward-looking statements made on this call represent our views as of today only and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on 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 Jeff Hackman.

Speaker #3: In addition, any forward-looking statements made on this call represent our views as of today only and should not be relied upon as representing our views as of any subsequent date.

Speaker #3: We specifically disclaim any obligations to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcasts on Fennec's website www.fennecpharma.com.

Speaker #3: Where it will be available for the next 30 days. And with that, I will now turn the call over to Jeffrey Hackman.

Jeff Hackman: Hey, thanks, Robert. Good morning, everyone. Thanks for joining the call today. It's hard to believe it's been one year since I stepped into the CEO role here at Fennec. When I joined, my focus was clear. I wanted to stabilize the business, sharpen our strategy, and build a strong foundation for sustainable growth. I'm proud to say that over the last 12 months, we've been delivering on these priorities while also driving the awareness and adoption of PEDMARC for the prevention of cisplatin-induced ototoxicity, or CIO. The results are beginning to materialize. We are now talking about three consecutive quarters of growth and more to come. You may recall, after I joined Fennec last year, I outlined a focused set of strategic imperatives to drive our execution and accelerate the long-term growth of PEDMARC, which, remember, still remains the first and only FDA-approved therapy in the U.S.

Speaker #4: Hey, thanks, Robert. Good morning, everyone. Thanks for joining the call today. Well, it's hard to believe it's been one year since I stepped in into the CEO role here at Fennec.

Speaker #4: You know, when I joined, my focus was clear: I wanted to stabilize the business, sharpen our strategy, and build a strong foundation for sustainable growth.

Speaker #4: I'm proud to say that over the last 12 months, we've been delivering on these priorities, while also driving the awareness and adoption of PEDMARC for the prevention of cisplatin-induced ototoxicity, or CIO.

Speaker #4: And the results are beginning to materialize. We are now talking about three consecutive quarters of growth, and more to come. You may recall after I joined Fennec last year, I outlined a focus set of strategic imperatives to drive our execution, and accelerate the long-term growth of PEDMARC.

Speaker #4: Which, remember, still remains the first and only FDA-approved therapy in the US and Europe to reduce the risk of CIO. Or permanent hearing loss, associated with cisplatin treatment.

Jeff Hackman: and Europe to reduce the risk of CIO or permanent hearing loss associated with cisplatin treatment. PEDMARC is specifically approved for pediatric patients one month of age and older with localized non-metastatic solid tumors. It is also recognized by the National Comprehensive Cancer Network, or NCCN, with a two-way recommendation for the U.S. for use in adolescent and young adult patients. Before we dive into the performance for the quarter, let me update you on significant progress that we've made during the first half of this year. First, we've made significant strides in increasing awareness of the unmet need among both oncology and broader cancer care communities. We've done this through continued presence at major conferences, targeted educational campaigns, and peer-to-peer interactions. We're seeing growing recognition that hearing loss from cisplatin is not just a side effect; it's preventable, and it's an issue with long-term consequences.

Speaker #4: PEDMARC is specifically approved for pediatric patients one month of age and older with localized non-metastatic solid tumors, and also is recognized by the National Comprehensive Cancer Network, or NCCN, with a two-way recommendation for the US for use in adolescent and young adult patients.

Speaker #4: But before we dive into the performance for the quarter, let me update you on significant progress that we've made during the first half of this year.

Speaker #4: First, we made significant strides in increasing awareness of the unmet need among both oncology and broader cancer care communities. We've done this through continued presence at major conferences, targeted educational campaigns, and peer-to-peer interactions.

Speaker #4: We're seeing growing recognition that hearing loss from cisplatin is not just a side effect, it's preventable. And it's an issue with long-term consequences. We're seeing the strongest momentum in both large community practices and academic centers.

Jeff Hackman: We're seeing the strongest momentum in both large community practices and academic centers and early validation of our targeted sales approach and enhanced patient support services. To that end, I'm pleased to share that a large national oncology group of providers recently added PEDMARC to its formulary for its use in patients under 40 years of age. This is one of the largest and fastest-growing groups in the country. It's a group of community-based oncology practices in the U.S. This decision reflects the growing recognition and the need to protect younger patients from cisplatin-induced hearing loss. We are excited and encouraged by what it signals in terms of broader momentum for PEDMARC and adoption in the community settings. Second, we are actively working to cement PEDMARC as the standard of care for CIO prevention.

Speaker #4: And early validation of our targeted sales approach and enhanced patient support services. And to that end, I'm pleased to share that a large national oncology group, of providers recently added PEDMARC to its formulary for its use in patients under 40 years of age.

Speaker #4: This is one of the largest and fastest-growing groups in the country, it's a group of community-based oncology practices in the US. This decision reflects the growing recognition and the need to protect younger patients from cisplatin-induced hearing loss, and we're excited and encouraged by what it signals in terms of broader momentum for PEDMARC and adoption in the community settings.

Speaker #4: Second, we are actively working to cement PEDMARC as the standard of care for CIO prevention. During the second quarter, we held multiple advisory boards with leading academic centers across the country, to better understand current approaches to diagnosing and managing CIO.

Jeff Hackman: During the second quarter, we held multiple advisory boards with leading academic centers across the country to better understand current approaches to diagnosing and managing CIO. The insights shared by key opinion leaders are now forming many of our cross-functional strategies. In parallel, positive feedback from existing accounts using PEDMARC continues to strengthen our confidence in our clinical value and support broader institutional adoption. I am pleased to also share today that ENCODA recently issued a positive Quality Intervention, or PQI, for PEDMARC. This is an important development that provides peer-reviewed practical guidance to oncology care teams on the use, administration, and timing of PEDMARC to prevent CIOs in pediatrics and AYA, or adolescent and young adult patients. ENCODA PQIs are widely used tools that support multidisciplinary cancer teams, including pharmacists, nurses, and oncologists, in delivering high-quality care for patients receiving oral and IV therapies in oncology.

Speaker #4: The insights shared by key opinion leaders are now forming many of our cross-functional strategies, in parallel, positive feedback from existing accounts using PEDMARC continues to strengthen our confidence in our clinical value and support broader institutional adoption.

Speaker #4: I'm pleased to also share today that NCOTA recently issued a positive quality intervention, or PQI, for PEDMARC. This is an important development that provides peer-reviewed, practical guidance to oncology care teams on the use, administration, and timing of PEDMARC to prevent CIO.

Speaker #4: In pediatric and AYA, or adolescent and young adult patients. NCOTA PQIs are widely used tools that support multidisciplinary cancer teams, including pharmacists, nurses, and oncologists.

Speaker #4: In delivering a high-quality care for patients receiving oral and IV therapies in oncology. But most importantly, we see PQI as a strong signal of growing clinical alignment around importance of preventing cisplatin-induced ototoxicity, and it supports our goal of establishing PEDMARC as the standard of care in this space.

Jeff Hackman: Most importantly, we see PQI as a strong signal of growing clinical alignment around the importance of preventing cisplatin-induced ototoxicity, and it supports our goal of establishing PEDMARC as the standard of care in this space. Third, we are expanding and educating on CIO and an important role of PEDMARC in preventing it, not just with oncologists, but beyond. Many healthcare professionals are involved in the patient journey, including ENTs, audiologists, nurses, and pharmacists. These groups are now engaging with Fennec and PEDMARC, and we are seeing the benefit of this multidisciplinary support in day-to-day clinical practices. We are reminded that in the expansion of the care of these oncology patients, especially when it comes to survivorship and quality of life, it goes beyond the role of just the oncologist.

Speaker #4: Third, we are expanding our CIO and educating on CIO and the important role of PEDMARC in preventing it. Not just with oncologists, but beyond.

Speaker #4: Many healthcare professionals are involved in the patient's journey, including ENTs, audiologists, nurses, and pharmacists. These groups are now engaging with Fennec, and PEDMARC, and we're seeing the benefit of this multidisciplinary support in day-to-day clinical practices.

Speaker #4: We are reminded that in the expansion that the care of these oncology patients, especially when it comes to survivorship and quality of life, it goes beyond the role of just the oncologist.

Jeff Hackman: The fourth point I want to make is on the access front. We have made significant progress with payers and providers alike. Our field access and reimbursement teams have been instrumental in ensuring smoother coverage and pathways and fewer barriers for the sites that are ready to treat. The strengthening of our Fennec HEARS patient assistance program has been central to this work. We have seen quarter-over-quarter growth in enrollment in Fennec HEARS programs and the newly revamped offerings that we are delivering, which are giving improved experiences through strengthened healthcare provider practices, patient services, expanded payer reimbursement support, and streamlined access to home nursing resources. Finally, on the activation side, while our near-term commercial focus remains on educating healthcare providers to support a shift in the standard of care, we are also strengthening our efforts to educate and engage patients and caregivers.

Speaker #4: Fourth point I want to make is on the access front. We've made significant progress with payers and providers alike. Our field access and reimbursement teams have been instrumental in ensuring smoother coverage and pathways and fewer barriers for the sites that are ready to treat.

Speaker #4: The strengthening of our Fennec HEARS patient assistance program has been central to this work. We've seen quarter-over-quarter growth in enrollment in Fennec HEARS programs and the newly revamped offerings that we're delivering.

Speaker #4: Which are giving improved experiences through strengthened healthcare provider practices, patient services, expanded payer reimbursement support, and streamlined access to home nursing resources. And finally, on the activation side, while our near-term commercial focus remains on educating healthcare providers to support a shift in the standard of care, we are also strengthening our efforts to educate and engage patients and caregivers.

Jeff Hackman: We are doing this through the support of several advocacy associations or organizations, such as the Testicular Cancer Awareness Foundation and activities surrounding initiatives like the Childhood Cancer Awareness Month. These efforts help raise awareness of the risk of CIO and encourage families to inform and have informed conversations about hearing protection during their treatment planning. Further, we are excited to announce that Fennec's senior leadership team and employees, along with several PEDMARC patients and their families, will ring the closing bell of the NASDAQ stock market on Friday, September 5th, 2025. While this is an exciting business milestone for Fennec, it is important. It is a really important symbolic reminder of our mission, which is to help more patients be able to hear their own remission bells. Turning to our second quarter 2025 results, revenue grew 33% year over year and 10% sequentially, with net revenues of $9.7 million.

Speaker #4: We are doing this through the support of several advocacy associations, or organizations. Such as the Testicular Cancer Awareness Foundation, and activities surrounding initiatives like the Childhood Cancer Awareness Month.

Speaker #4: These efforts help raise awareness of the risk of CIO and encourage families to inform, and have informed conversations about, hearing protection during their treatment planning.

Speaker #4: Further, we are excited to announce that Fennec's senior leadership team and employees along with several PEDMARC patients and their families will ring the closing bell of the Nasdaq stock market on Friday, September 5th, 2025.

Speaker #4: While this is an exciting business milestone for Fennec, it's important it's a really important symbolic reminder of our mission. Which is to help more patients be able to hear their own remission bells.

Speaker #4: Now, turning to our second quarter 2025 results. Revenue grew 33%, year over year, and 10% sequentially with net revenues of $9.7 million. This kind of quarter-over-quarter growth just doesn't happen by chance.

Jeff Hackman: This kind of quarter-over-quarter growth just does not happen by chance. It reflects a disciplined execution and a completely overhauled go-to-market strategy and having a top-down talent in the right positions to execute this excellence. This quarter-over-quarter growth includes the addition of 14 new accounts, some of which are part of two large community oncology groups, or purchase or GPOs. Within these networks, we have seen PEDMARC activation in Q2, which continues to grow into Q3. Looking into Q3, we expect additional accounts within both of these networks to activate and prescribe PEDMARC. I am incredibly proud of the Fennec team and encouraged by the continued growth that we are seeing, which reinforces our belief in the scalability of this model and the growing demand for PEDMARC across these key markets. With that, I will now turn it back over to Robert.

Speaker #4: It reflects a disciplined execution and a completely overhauled go-to-market strategy, as well as having top-down talent in the right positions to execute this excellence. This quarter-over-quarter growth includes the addition of 14 new accounts, some of which are part of two large community oncology groups, or purchase or GPOs.

Speaker #4: Within these networks, we've seen PEDMARC activation in Q2, which continues to grow into Q3. Looking into Q3, we expect additional accounts within both of these networks to activate and prescribe PEDMARC.

Speaker #4: I'm incredibly proud of the Fennec team and encouraged by the continued growth that we're seeing with which reinforces our belief in the scalability of this model and the growing demand for PEDMARC across these key markets.

Speaker #4: With that, I'll now turn it back over to Robert.

Robert Andrade: Thank you, Jeff. Really amazing to think that just one year ago, we did our first conference call together and the amount of progress to date under your leadership. I remember on that call both thanking our shareholders for their support and patience as we underwent the transition and stating that I believe the opportunity for Fennec Pharmaceuticals was significant with proper execution ahead of us.

Speaker #3: Thank you, Jeff. Really amazing to think that just one year ago, we did our first conference call together. And the amount of progress to date under your leadership.

Speaker #3: I remember on that call, both thanking our shareholders for their support and patience as we underwent the transition. And stating that, I believe, the opportunity for Fennec was significant.

Speaker #3: With proper execution ahead of us. Further, I'd like to give much appreciation and recognition to our new leadership team that Jeff brought into Fennec only nine months ago.

Robert Andrade: Further, I would like to give much appreciation and recognition to our new leadership team that Jeff brought into Fennec Pharmaceuticals only nine months ago and who have been on the front lines in this execution: Christy Cioppi, our Chief Strategy Officer and leader in many areas, including our awareness and marketing initiatives; Terry Evans, our Chief Commercial Officer, who has primed our commercial team for optimal excellence; and Pierre Saad, our Chief Medical Officer, whose experience and knowledge have transformed our medical team with new energy and vigor and the proper tools to educate and support providers and patients. I believe we are just getting started. Now on to the details. Our press release contains some of our financial results for the second quarter of 2025, which can be viewed on the Investors and Media section of our website.

Speaker #3: And who have been on the front lines in this execution. Kristy Chiappi, our Chief Strategy Officer, and leader in many areas, including our awareness and marketing initiatives.

Speaker #3: Terry Evans, our Chief Commercial Officer, who has primed our commercial team. For optimal excellence. And Pierre Saad, our Chief Medical Officer, who's experience and knowledge has transformed our medical team with new energy and vigor and the proper tools to educate and support providers and patients.

Speaker #3: I believe we are just getting started. Now onto the details. Our press release contains some of our financial results for the second quarter of 2025.

Speaker #3: Which can be viewed on the investor and media section of our website. Rather than read through all those details, my comments today will focus on some key financial results.

Robert Andrade: Rather than read through all those details, my comments today will focus on some key financial results. As Jeff outlined, for the second quarter of 2025, the company recorded net product sales of $9.7 million, representing a 33% increase compared to the same period last year and 10% growth over the first quarter of this year and matching the highest quarterly net product sales in the history of Fennec Pharmaceuticals. Of significance, we are pleased to report our third consecutive quarter of sequential growth in net product sales. We have a great trend forming. Our revenue performance continues to demonstrate strong growth and commercial momentum, and we believe this is just getting started. As mentioned in our previous earnings, we are focused on growing net product sales throughout 2025.

Speaker #3: As Jeff outlined, for the second quarter of 2025, the company recorded net product sales of $9.7 million, representing a 33% increase compared to the same period last year.

Speaker #3: And 10% growth over the first quarter of this year, matching the highest quarterly net product sales in the history of Fennec. Of significance, we are pleased to report our third consecutive quarter of sequential growth in net product sales.

Speaker #3: We have a great trend forming. Our revenue performance continues to demonstrate strong growth and commercial momentum and we believe this is just getting started.

Speaker #3: As mentioned in our previous earnings call, we are focused on growing net product sales throughout 2025. Importantly, we anticipate the most significant quarterly growth in the second half of 2025.

Robert Andrade: Importantly, we anticipate the most significant quarterly growth in the second half of 2025, when all the foundational pillars and initiatives we have implemented and continue to optimize are expected to materially impact the growth of PEDMARC. The strong performance reflects both successful retention of existing customers and the exciting new uptake and demand for PEDMARC by new customers. Further, the launch of PEDMARQSI by Norgine in the EU is well underway in the United Kingdom and Germany, and we are pleased with the traction to date. We expect to provide additional updates on milestones and royalties from this partnership with Norgine in the quarters to come. Turning to our expenses, our total cash operating expenses for the quarter exclude non-cash stock-based compensation with approximately $11 million. This represents an increase of roughly $2 million compared to the first quarter of this year.

Speaker #3: When all the foundational pillars and initiatives we have implemented and continue to optimize are expected to materially impact the growth of PEDMARC. The strong performance reflects both successful retention of existing customers and the exciting new uptake and demand for PEDMARC by new customers.

Speaker #3: Further, the launch of PEDMARC by Norgene in the EU is well underway in the United Kingdom and Germany. And we are pleased with the traction to date.

Speaker #3: We expect to provide additional updates on milestones and royalties from this partnership with Norgene in the quarters to come. Turning to our expenses, our total cash operating expenses for the quarter exclude non-cash stock-based compensation.

Speaker #3: With approximately $11 million. This represents an increase of roughly $2 million compared to the first quarter of this year. The quarter-over-quarter increase was primarily driven by ongoing investments in marketing, additional headcount, as well as continued efforts related to our intellectual property.

Robert Andrade: The quarter-over-quarter increase was primarily driven by ongoing investments in marketing, additional headcount, as well as continued efforts related to our intellectual property. As is customary with our business, cash operating expenses are higher in the first half of the fiscal year, largely as a result of commercial and marketing spending patterns, and we expect these cash expenses to decrease in the second half of 2025. The company recorded $4.4 million in selling and marketing expenses in the second quarter of 2025 compared to $2.9 million in the first quarter of 2025 and $4.7 million in the second quarter of 2024. The primary drivers of the increase in the quarter include additional marketing expenses and a one-time accrual reversal that occurred only in Q1 2025.

Speaker #3: As is customary with our business, cash operating expenses are higher in the first half of the fiscal year. Largely as a result of commercial and marketing spending patterns.

Speaker #3: And we expect these cash expenses to decrease in the second half of 2025. The company recorded $4.4 million in selling and marketing expenses in the second quarter of '25.

Speaker #3: Compared to $2.9 million in the first quarter of '25. And $4.7 million in the second quarter of 2024. The primary drivers of the increase in the quarter include additional marketing expenses and a one-time accrual reversal that occurred only in Q1 2025.

Robert Andrade: On the G&A front, the company recorded $7 million in the second quarter of 2025 compared to $6.1 million in the earlier quarter of the first quarter of 2025 and $6.9 million in the second quarter of 2024. For the second quarter of 2025, G&A expenses were consistent on a year-over-year basis and increased quarter-over-quarter largely due to the following: one, increased non-cash stock compensation, and two, ongoing litigation and intellectual property expenses. For the quarter, the company spent roughly $4 million in cash. Cash and cash equivalents were approximately $18.7 million as of June 30th, 2025. We remain confident that full-year cash operating expenses will be similar in 2025 to that of 2024, or roughly $33 million. This includes an increase in commercial expenses, including higher headcount and marketing expenses, offset by the elimination of European free commercialization costs, which only occurred in 2024.

Speaker #3: On the G&A front, the company recorded $7 million in the second quarter of 2025 compared to $6.1 million in the earlier quarter of first quarter of '25 and $6.9 million in the second quarter of '24.

Speaker #3: For the second quarter of 2025, G&A expenses were consistent on a year-over-year basis and increased quarter-over-quarter largely due to the following: one, increased non-cash stock compensation.

Speaker #3: And two, ongoing litigation and intellectual property expenses. For the quarter, the company spent roughly $4 million in cash. Cash and cash equivalents were approximately $18.7 million as of June 30th, 2025.

Speaker #3: We remain confident that full-year cash operating expenses will be similar in 2025 to those of 2024, at roughly $33 million. This includes an increase in commercial expenses, including higher headcount and marketing expenses, offset by the elimination of European free commercialization costs, which only occurred in 2024.

Robert Andrade: Importantly, we have several levers to potentially increase the cash balance in the second half of 2025. Product revenues continue to gain momentum, and we aim towards cash profitability as cash expenses also decrease in the second half. Two, potential milestones and royalties from the Norgine partnership. Three, the possible monetizations or partnerships after the release of the Japan study results, which are expected in the fourth quarter. An operator, with that, will now open up the call for questions.

Speaker #3: Importantly, we have several levers to potentially increase the cash balance in the second half of 2025. Product revenues continue to gain momentum, and we aim towards cash profitability as cash expenses also decrease in the second half.

Speaker #3: Two potential milestones and royalties from the Norgene partnership; and three, the possible monetization or partnership after the release of the Japan study results, which are expected in the fourth quarter.

Speaker #3: An operator with that will now open up the call for questions.

Operator: Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Chase Knickerbocker with Craig-Hallum. Your line is now open.

Speaker #1: Thank you. As a reminder to ask a question, please press star when one of your telephone and wait for your name to be announced.

Speaker #1: To withdraw your question, please press star once again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Chase Knickerbocker with Craig Hallum.

Speaker #1: Your line is now open.

Chase Knickerbocker: Good morning. Thanks for taking the questions. Jeff Hackman, maybe just to start, would you guys be willing to share an active prescriber's number, particularly obviously within AYA? It would be helpful to see the number of active prescribers you have within that cohort.

Speaker #5: Good Good morning. Thanks for taking the questions. Jeff, maybe just to start, can would you guys be willing to share an active an active prescriber's number, you know, particularly obviously with AYA within AYA?

Speaker #5: Is that just it would be helpful to see kind of the number of active prescribers you have within that kind of cohort.

Jeff Hackman: Yeah. Hey, Chase, how are you? Good morning. We do not share the number, the cumulative number, obviously, for a bunch of different reasons on that guidance. Tell me a little bit more about what you are maybe a little bit more detailed, though, and I can maybe share some other specifics if you are looking for.

Speaker #6: Yeah. Hi, Chase. How are you? Good morning. We don't share the number, you know, the cumulative number. Obviously, for a bunch of different reasons, on that guidance.

Speaker #6: tell me a little bit more about what you're maybe a little bit more detail, though, and I can maybe share some other, other specifics if you what you're looking for.

Chase Knickerbocker: Just an active number of current writers, basically. You have shared double-digit accounts, increase sequentially. Maybe on that front, if you would be willing to share an active account number just so we can think about the ramp from here in AYA.

Speaker #5: Just, just an active number of, you know, current writers, basically. I mean, you shared kind of double-digit accounts, in, you know, increase sequentially.

Speaker #5: I mean, maybe on that front, kind of, you know, if you'd be willing to share kind of an active account number, just so we can think about kind of the ramp from here in AYA.

Jeff Hackman: Yeah, yeah. Let me go back and look at that. It might be something that we might be able to share in future quarters, Chase. I want to be careful, especially when you start getting a little bit more detailed on actual accounts that are out there, and obviously, you have to protect that relationship. But obviously, doing something with some numbers might not be, it could be something we could do in the future.

Speaker #6: Yeah. Yeah. let me, let me go back and look at that. It might be something that we might be able to share in the future quarters, Chase.

Speaker #6: You know, I don't see that. You know, I want to be careful, especially when you start, you know, getting a little bit more detailed, right, on actual accounts that are out there. And obviously, you have to protect that relationship.

Speaker #6: but, but obviously doing something with, with some numbers might not be you know, it could be something we could do in the future, so.

Chase Knickerbocker: Yeah, and maybe if we just focus on that double-digit accounts sequentially, Jeff. Can you give us some visibility into maybe how many patients within those accounts in AYA are treated with cisplatin and what your overall opportunity is, maybe just in those accounts that have added on sequentially?

Speaker #3: Yeah. And I'll also.

Speaker #5: Maybe if we just focus on that double-digit account sequentially, Jeff. I mean, can you give us some, you know, kind of visibility into maybe how many patients within those accounts, in AYA are, are, are, are treated with cisplatin and kind of what you're kind of overall opportunity is maybe just in those accounts that have kind of added on sequentially?

Speaker #6: Mm-hmm. Yeah. I mean, we talked about, you know, the in the AYA market, it's, it's, it's 10 times the size of the pediatric. It's about 20,000 patients.

Jeff Hackman: Yeah, I mean, we talked about, you know, in the AYA market, it's 10 times the size of the pediatric. It's about 20,000 patients in that population between, you know, ages 15 to 39 that are treated with cisplatin. So, you know, that population is significant. That's, you know, that's our market. That's where, you know, we've divided up the country into our, you know, commercial teams and supplied them with that data.

Speaker #6: In that population, between, you know, ages 15 to 39, that are treated with cisplatin. And so, you know, that population is significant. That's, you know, that's our market.

Speaker #6: That's where, you know, we've divided up the country into our, you know, into our, you know, commercial teams, and, and supplied them with that data.

Chase Knickerbocker: Yeah, and Chase, I will add, which is important to know, it starts generally with one patient at a center or at a hospital. We have successful administration. We can create the awareness. We have successful administration, and we have successful reimbursement that expands. What we have been able, what we have witnessed in particular in Q2 over Q1, is the retention of those existing customers and that also augmenting the amount of patients within those existing customers. I think where we wanted to shed light was, you know, we had 14 new accounts. Do not get focused on the amount of accounts because each account is unique, but we are growing. The goal is obviously then to build that existing base and augment that as well. Maybe just a little bit of additional color on that.

Speaker #3: Yeah. And, and Chase, I'll, I'll add, which is important to note, it starts it starts with generally with one patient. at a center or at a hospital.

Speaker #3: we have successful administration, we can create the awareness, we have successful administration, and we have successful reimbursement. That expands. And what we've been able what we've witnessed in particular, in Q2 over Q1 is the retention of those existing customers and that also augmenting the amount of patients within those existing customers.

Speaker #3: So I think where we where we wanted to shed light was, you know, we had 14 new accounts. Don't get focused on the amount of accounts because each account is unique.

Speaker #3: But we are growing. And the goal is obviously then to build that existing base and augment that as well.

Speaker #5: Yeah. Maybe just a little bit of additional color on that. You know, when that, you know, account starts out, and let's say it's a single patient, you know, what's kind of the, the cadence in which you start seeing increased writing, from, you know, said account?

Chase Knickerbocker: You know, when that, you know, account starts out and let us say it is a single patient, you know, what is kind of the cadence in which you start seeing increased writing from, you know, said account?

Speaker #6: Mm-hmm. Yeah. We see it. we saw it more in the second quarter, as we started to get experience, Chase. That's exactly what you know, we're, we're Robert was going was is we needed to have that initial, patient, in that center or that, that practice go through, you know, PEDMARC therapy, see the positive, outcome, see that it works, how they administer it, in some cases actually using our Fennec HEARS program.

Jeff Hackman: Yeah, we see it. We saw it more in the second quarter as we started to get experience, Chase. That is exactly where Robert was going. We needed to have that initial patient in that center or that practice go through PEDMARC therapy, see the positive outcome, see that it works, how they administer it, in some cases, actually using our Fennec HEARS program. Now, that is the area where obviously a lot of our folks will focus their efforts, is to expand now in those same practices because remember, these physicians and these oncology practices have multiple cisplatin patients that they are going through. That is where we saw a lot of our growth, was through expansion of current accounts in Q2. We will see even more of that as we go through the year.

Speaker #6: And now we, you know, that's the area where obviously a lot of our folks will focus their efforts is to expand now in those same practices. Because remember, these physicians and these oncology practices have multiple cisplatin patients that they're going through.

Speaker #6: So, that's where we saw a lot of our growth: through the expansion of current accounts in Q2. We'll see even more of that as we go through the year.

Chase Knickerbocker: Got it. Maybe just last for me, guys, sorry to get so many in here. On the EU side, could you share the amount of royalty revenue that was in the quarter from Norgine? Then just kind of general thoughts on kind of how that ramp is going with your partner, particularly as we go into the back half of the year here. On kind of final German pricing, do you have a thought on when we should hear back on that? Thanks for taking the questions.

Speaker #5: Got it. Maybe just last for me, guys. Sorry to get somebody in here. But, on the EU side, could you share the amount of royalty revenue that was in the quarter from Norgene?

Speaker #5: And then just kind of general thoughts, on kind of how that ramp is going, with your, with your partner, particularly as we go into the back half of the year here.

Speaker #5: And then on, on kind of final German pricing, I mean, do you have a, a thought on when we should hear back on that?

Speaker #5: thanks for taking the questions.

Robert Andrade: Yeah, thanks, Chase. To step back a little, as you are aware, the Norgine partnership has two primary components. The first component are the royalties, and that is a percent. It starts from the mid-teens of Norgine sales. The second component is north of $200 million potential milestones. We started to see some significant traction in the second quarter from that partnership. As a reminder, they launched late in the first quarter. In the second quarter, we started to see some traction really out of the United Kingdom as they work to get the different P&T approvals within Germany and final pricing later in the year. That number is not material enough at this point to move our own financials in an aggregate basis. But the sequential certainly increase in traction is significant. They plan to then roll that out for the broader EU5 later this year, early next year.

Speaker #3: Yeah. Thanks, Chase. to step to step back a little, as, as you're aware, the Norgene partnership has two primary components. The first component is the are the royalties.

Speaker #3: And that is a percent, starts in the mid-teens. Of Norgene sales. And the second component is north of $200 million potential milestones. we started to see some significant traction, in the second quarter from that partnership.

Speaker #3: As a reminder, they launched late in the first quarter. The second quarter, you start we started to see some traction really out of the UK.

Speaker #3: As they work to get the different P&T approvals within Germany and final pricing, you know, later in the year. that number is not material enough at this point to move our number to move our own financials in an aggregate basis.

Speaker #3: but the sequential certainly increase and traction, is significant. They planned to then roll that out to the broader EU five, later this year, early next year.

Robert Andrade: So you are talking Italy, Spain, France, and also to the Nordic regions. So we are quite enthusiastic about that opportunity. Near term, there are two primary milestones ahead of us. One is based on aggregate calendar year sales, and the other one is based on German pricing. We look forward to giving updates on that in the quarters to come.

Speaker #3: So you're, you're talking Italy, Spain, France, and also to the Nordic regions. So we're, we're, we're quite enthusiastic about that opportunity. Near term, there are two, two primary milestones, ahead of us.

Speaker #3: One is based on aggregate calendar year sales, and the other one is based on German pricing. We look forward to giving updates on that in the quarters to come.

Chase Knickerbocker: Thanks, guys.

Speaker #5: Thanks, guys.

Operator: Thank you. Our next question comes from the line of Susan Logan-Nathan with Stephens. Your line is now open.

Speaker #1: Thank you. Our next question comes from the line of Sudan Logan Nathan with Stevens. Your line is now open.

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

Speaker #7: Hi, good morning. congrats on the progress in the second quarter and, thank you for taking my questions. my first one, I wanted to just get some color on the, the mix of new and repeat customers.

Speaker #7: maybe you can provide a, a percentage amount of either to, kind of get a look at the, potential net penetration. and how that's progressing.

Jeff Hackman: Yeah, initially, when we started, we jumped out to mostly new customers. We saw, I mean, if I could give you percentages, when we first started in the AYA space, all of our customers were new. We really got out and tried to get experience with PEDMARC in these patients. We saw in the second quarter now that start to shift down to some higher percentages of these repeat customers. We will see, I do not want to give a percentage because it is a moving target as we go, but we are seeing new patients coming in. We talked about 14 new accounts. We talked about growing these new accounts, and it is really critical for us because there are so many accounts out there not touching PEDMARC.

Speaker #3: Yeah. Initially, when we started, we jumped out to, mostly new customers, right? So we saw a per you know, I mean, if I, I could give you percentages, when we first started in the AYA space, all of our customers were new, right?

Speaker #3: We really got out and, and, and, and tried to get experience with PEDMARC in these patients. we saw in the second quarter now, that start to shift, down to, some, some higher percentages of, of these repeat customers.

Speaker #3: and so we, we'll see, you know, we're, we I we I don't want to give a percentage, because it's a moving target. as we go, but, we are seeing new patients coming in.

Speaker #3: We talked about 14 new accounts. We discussed the importance of growing these new accounts, as it's critical for us because there are so many accounts out there not touching PEDMARK.

Jeff Hackman: I think we will continue to see these new account additions, but as we grow our business and get bigger, we will start, add those additional accounts behind those that are repeat customers. At this point, we are starting to see the mix start to even out a little bit more, new customers versus repeat customers, and we will probably continue to see that throughout the rest of this year.

Speaker #3: so, I think we'll continue to see this, the new account additions, but as we grow our business and get bigger, we'll start, you'll add those, additional, accounts behind those that are, repeat customers.

Speaker #3: So, you know, at this point, it's, it's, we're starting to see the mix start to even out a little bit more. new customers versus, repeat customers.

Speaker #3: and we'll probably continue to see that throughout the rest of this year.

Susan Logan-Nathan: Great. I appreciate that color. The second one I wanted to ask here is, with the trial results in Japan expected this fall, could you elaborate on the Japanese market opportunity? For example, the prevalence of CIO in both pediatric and AYA populations, then outline your plans for a potential commercial rollout, including whether you anticipate partnering locally or the size of the salesforce you may implement there in that region.

Speaker #7: Great. I appreciate that color. my second one wanted to ask here is, you know, with the trial results in Japan expected this fall, could you elaborate on the Japanese market opportunity?

Speaker #7: You know, for example, the prevalence of CIO in both pediatric and AYA populations. And then outline your plans for a potential commercial rollout, including whether you anticipate partnering locally or the size of, Salesforce you may, implement there in that region.

Jeff Hackman: Right. We are in the final discussions of trying to understand all the data. We will have some meetings in September here with the investigators to really go through all the data tables and get ourselves familiar with that. That is the first part, just really making sure we understand and get all the data. We are working with our investigators, as well as with some consultants, to start to look at what our approach is. What is our regulatory approach and how fast do we get this product submitted? As you know, in Japan, you will need a partner to submit it to the PDMA. We are looking at that approach and that partner strategy in parallel. We have said this before, we are in discussions with folks, and that is an ongoing process as we move forward. Japan is about a third of the size of the U.S.

Speaker #3: Right. We so we're in the final, discussions of trying to understand all the data, we'll have, some meetings in September here with the, investigators to really kind of go through all the data tables and, and, and get ourselves familiar with that.

Speaker #3: So that's the first part is is really, making sure we understand and, and get all the data. we are, working with, the our investigators as, as, as well as with some consultants to kind of start to look at, okay, what's our, what's our approach?

Speaker #3: what, what is our regulatory approach and how fast, do we want to get this product submitted? As you know, in Japan, you'll need a partner to submit it to the PDMA.

Speaker #3: And so we, we're doing we're looking at, that approach and that partner strategy, in parallel. We're in, we've, we've said this before, we're in discussions with folks and, that's, that's an ongoing, you know, that's a, that's an ongoing, process.

Speaker #3: As we, as we move forward, Japan's about the third, a third of the size of the US and Europe. when you look at CIO usage, and so that kind of gives you a feel, for the, for the numbers, remember this will be a, a probably a pediatric indication in, in Japan.

Jeff Hackman: and Europe when you look at CIO usage. That kind of gives you a feel for the numbers. Remember, this will probably be a pediatric indication in Japan. We had 10 centers that participated in the trial. These centers are all excited about getting an opportunity to continue to use this product outside of the clinical trial. So we have had some really good feedback from the folks in country. There is more to come here. We will probably have more updates in September as we see some of the final data and then how we are going to approach this. Timing-wise, we are trying to really focus it as fast as we can move this forward. We do not want these investigators and folks in Japan who have touched this product to go a long time without having to be able to have an approved product.

Speaker #3: we, you know, we had 10 centers that were, that participated in the trial. it's a, these centers are all excited about getting, you know, an opportunity to continue to use this product.

Speaker #3: you know, outside of the clinical trial. So we've had some really good, feedback, you know, from the folks in country. So there's more to come here.

Speaker #3: We'll probably have more updates in September as we see some of the final data, and then how we're going to approach this.

Speaker #3: timing-wise, we're trying to really focus it as fast as we can, we can, can move this forward. you know, we don't want, these, investigators and folks in Japan who have touched this product to go a long time without having to be able to, to have an approved product, right?

Jeff Hackman: So the faster we can get this into the Japanese regulatory authorities, the better.

Speaker #3: So, the faster we can get this, you know, into the Japanese regulatory authorities, the better. Yeah. And, just to add, we've had a lot of enthusiasm from investigators, from patients, and a lot of unsolicited interest within Japan and the broader Asia area for the product.

Robert Andrade: Yeah, and just to add, we've had a lot of enthusiasm from investigators, from patients, and a lot of unsolicited interest within Japan and the broader Asia area for the product. It's a known product. It's known to work. The reimbursement system is quite sophisticated. Having been through the Norgine process a year ago, I think it's quite analogous to it. We look forward to giving more updates.

Speaker #3: it's a, it's a known product. It's known to work. The reimbursement system is, is quite sophisticated. having been through the Norgene process a year ago, I think it's, it's quite analogous to it.

Speaker #3: So, we look forward to giving more updates.

Susan Logan-Nathan: Great to hear. Just lastly, if I can squeeze one more in, do you anticipate the operating expenses to remain relatively stable in the second half of the year? In what areas do you expect will represent maybe your larger expenditures in the upcoming quarters and may drive those expenditures? I know you mentioned, obviously, some of the IP expenses needed for the EU in the second quarter. I am just kind of curious if there is any more, kind of maybe one-time expenses in the second half of this year as you are going to launch.

Speaker #7: Great to hear. just lastly, if I can squeeze one more in. do you anticipate the operating expenses to remain relatively stable in the second half of the year?

Speaker #7: And, you know, what areas do you expect will represent maybe your largest expenditures in the upcoming quarters and may drive those expenditures? I know you mentioned, obviously, some of the IP, expenses needed for the EU, in the second quarter.

Speaker #7: You know, just kind of curious if there's any more, you know, kind of maybe one-time, expenses in the second half of this year as you're growing the launch.

Robert Andrade: Yeah, thank you. So the first half of the year is heavier from a cash OpEx. A lot of our contracts are structured with 50% upfront, then the balance over the back half of the year. I, as mentioned in the stated remarks, expect both our second half expenses to go down. So from a cash operating expense, we are roughly $20 million for the first half. I expect it to go down, and the full year to be consistent with 2024 from a cash OpEx, which was roughly $33 million to $34 million. In the second quarter, specifically on a non-cash basis, there was also a jump up in stock-based compensation as we aligned what we believe is a really effective and exciting team here with incentives that are aligned with our shareholders.

Speaker #3: Yeah. Thank you. So, the first half of the year is heavier from a cash, opex. A lot of our, our contracts are structured, with 50% upfront and then the back, you know, and the balance over the back half of the year.

Speaker #3: So I, I, as, as mentioned in the, in the stated remarks, I expect, both our second half expenses to go down. So from a cash operating expense, we are roughly $20 million for the first half.

Speaker #3: So I expect it to go down. and the full year to be consistent with '24 from a cash opex, which was roughly $33 million to $34 million.

Speaker #3: In the second quarter specifically, on a non-cash basis, there was also a jump in stock-based compensation. As we aligned, what we believe is a really effective and exciting team here, with incentives that are aligned with our shareholders.

Susan Logan-Nathan: Great, thanks. I really appreciate all the insight here. Again, congrats on the second quarter.

Speaker #7: Great. Thanks. I really appreciate all the insight here. Again, congrats on the good things.

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

Speaker #1: Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is now open.

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

Speaker #8: Oh, got it. Thanks for taking the questions. This is Chad on for Jason. we were wondering if you could provide some additional color on getting the PQI and how this differs from NCCN guidelines.

Jeff Hackman: Sure. Hey, Chad. How are you? Nice to hear from you. They differ. Let me say, the ENCODA PQIs are a peer-reviewed guidance document, really. It really is a guidance document to really help patient care and oncology practices. So it is a little bit different because it comes from the ENCODA stands for the National Community Oncology Dispensing Association. So these are kind of standardized evidence-based kind of practice management type of recommendations. So they are a little bit more focused than the NCCN guidelines, right? The purpose of these PQIs, we call them, are to kind of really focus on patient outcomes and really look at standardizing care and optimizing treatments and enhancing communications with the oncology teams. So they are a little bit more focused. They are a little bit below the level of these NCCN guidelines.

Speaker #3: Sure. Chad. How are you? Nice to, nice to hear from you. yeah. The, the, the, they differ let me t the NCOTA PQIs are a peer-reviewed guidance document, really.

Speaker #3: and it really is a guidance document to really help, patient care and oncology practices. So, it's a little bit different because it's, Hey, it's, it comes from, the NCOTA stands for the National Community Oncology Dispensing Association.

Speaker #3: So, these are kind of these are standardized, evidence-based kind of practice management type of, of recommendations. So they're a little bit more focused than, the NCCN guidelines, right?

Speaker #3: And the purpose of these PQIs, we call them, are to kind of really focus on patient outcomes. and really look at standardizing care and optimizing treatments and enhancing communications with the oncology teams and so they're a little bit more focused.

Speaker #3: They're a little bit below the level of, of these NCCN guidelines. they cover various aspects, not just cancer care, but, but also kind of, how to select patients, or, monitoring, or counseling, or management strategies.

Jeff Hackman: They cover various aspects, not just cancer care, but also kind of how to select patients or monitoring or counseling or management strategies. So we really think that this is an important milestone for us to now have a PQI for PEDMARC. They have now, that is access. People can have information about our products, really, without us having to be there. They can access that information through these PQIs. So we are very excited about it.

Speaker #3: And so, we really think that this is an important, milestone for us to, to now have, a PQI for PEDMARC, they have now, you know, that's access people can have information about our product really, you know, without us having to be there.

Speaker #3: They can access, access that, that information through these PQIs. So I we, we, we're very excited about it.

Chase Knickerbocker: Thanks. That was helpful. Could you just talk about how you're splitting marketing resources between the larger AYA opportunity and earlier pediatric populations? Are you laser-focused on driving this newly open market, or is there some balance you're targeting there?

Speaker #8: Thanks. That was helpful. and then also, could you just talk about how you're splitting, you know, marketing resources between the larger, AYA opportunity and earlier pediatric population?

Speaker #8: Are you, you know, laser-focused on driving this newly opened market or is there some balance you're targeting there?

Jeff Hackman: Yeah, the balance between the two markets, I mean, listen, we have said all along that we believe that the opportunity is much larger in AYA, but that we do not, especially in the academic institutions, you know, when we are in an academic institution, we are there, you know, on the pediatric side as well as the AYA side. Obviously, we know that the size in the market is much different, but there is still that incredible need for PEDMARK in these pediatric settings. So we still continue to get use there. We still continue to see growth. We do not see the growth that we see in AYA, of course, because, you know, they are in this launch phase, and it is obviously much larger. But, you know, we instruct our commercial organization as well as our medical organization.

Speaker #3: Yeah. The balance between the two markets, I mean, listen, we, we've said all along that I we believe that the opportunity is much larger in AYA, but that we, we don't, especially in the academic institutions, you know, we're when we're in an academic institution, we're there, you know, on the pediatric side as well as the AYA side.

Speaker #3: the obviously, we know the, the size and the market is much different. but, there's still that incredible need for PEDMARC in the, you know, these pediatric settings.

Speaker #3: And so we still continue to get use there. We still continue to see growth. We don't see the growth that we see in AYA, of course, because, you know, during this launch phase, and it's obviously much larger.

Speaker #3: But, but, you know, we instruct our commercial organization as well as our, our medical organization, when we're in the, in, in these institutions, we're doing both PED and AYA, you know, commercial marketability.

Jeff Hackman: When we are in these institutions, we are doing both PED and AYA, you know, commercial marketability.

Robert Andrade: Yeah, and just to add, doors have opened for us in the AYA as a result of our pediatric relationships that we have obviously built over the last several years. Conversely, doors have also opened for pediatric as a result of the progress that we have made with AYA. That is really the beauty of the opportunity. Different size market opportunities, but really growth potential in each one.

Speaker #3: Yeah. And just to add, Chad, doors have opened for us in the AYA as a result of our pediatric relationships that we've obviously built over the last several years.

Speaker #3: And conversely, doors have also opened for pediatric, as a result of the progress that we've made with AYA. And so that's, that's really the beauty of, of the opportunity.

Speaker #3: different size market opportunities. But really growth potential in each one.

Chase Knickerbocker: Okay, great. Thanks, guys. That's all from me. Congrats again.

Speaker #8: Okay. Great. Thanks, guys. That's all from me. Congrats again.

Robert Andrade: Thanks.

Jeff Hackman: Yeah, thanks.

Speaker #3: Thanks.

Speaker #6: Yeah. Thanks.

Operator: Our next question comes from the line of Raghuram Selvaraju with H.C. Wainwright. Your line is now open.

Speaker #1: Our next question comes from the line of Ram Savaraju with HC Wainwright. Your line is now open.

Susan Logan-Nathan: Hi, good morning. This is Eduardo on for Rom. I was wondering if you could provide any details that you, how proactive the FDA has been recently in seeking to ensure that the market is complying with its guidance not to substitute PEDMARC with other compounded versions of your API and that formulation?

Speaker #7: Hi. Good morning. This is Eduardo on for Ram. I was wondering if, you could provide any details that you how proactive the FDA has been recently, in seeking to ensure that the market is complying with its guidance, not to substitute PEDMARC with other compounded versions of your API and the, that formulation?

Jeff Hackman: I missed the beginning of that. I am sorry, Eduardo, can you repeat that again? Sorry.

Speaker #3: Yeah. I missed that you I missed the beginning of that. I'm sorry. Eduardo, can you repeat that again? Sorry.

Susan Logan-Nathan: Sure, no problem. Just how proactive the FDA has been in ensuring the market is complying with its guidance not to substitute PEDMARC with compounded versions of STS.

Speaker #7: Sure. No problem. Just how proactive the FDA has been in ensuring the market is complying with its guidance, not to substitute PEDMARC with compounded versions of STS.

Jeff Hackman: You know, we've had the FDA put out a statement. I think that statement is clear. That statement is part of what we continue to utilize when we see that compounding happening. The FDA has been supportive of the use of FDA-approved product or PEDMARK in this situation. It continues, Eduardo, to be probably one of the bigger areas in the pediatric discussion when we are looking at especially opening up new institutions. We want to make sure, and we talk about it all the time, that there's a, we're the only FDA-approved product that's on the market. I think it's important to realize in the AYA space, unlike the pediatric space, that the reimbursement and the usage of compounded products are much different in the community settings as well.

Speaker #3: Well, you know, we we've had a or, you know, in the past, we've had the FDA, you know, put out a statement, I think that statement.

Speaker #3: Clear, we, that, that statement is part of, you know, what we continue to utilize when we see that, you know, compounding happening. you know, they are, the FDA has been supportive of the use of, of, you know, FDA-approved product or PEDMARC in this situation.

Speaker #3: So I mean, it, it, it continues, Eduardo, to be probably the one of the bigger areas in the pediatric discussion, when we are looking at, you know, especially opening up new institutions, we want to make sure, and we, we talk about it all the time about that, that there's a, there we're the only FDA-approved product.

Speaker #3: That's on the market. I think it's important, to realize in the AYA space, unlike the pediatric spaces, is that, the reimbursement, and the, the usage of, of compounded products, are much different.

Speaker #3: in the community settings as well. So we don't have as much of an issue there as, as we do in some of the, the, you know, the academic centers, for in the pediatric space.

Jeff Hackman: We don't have as much of an issue there as we do in some of the academic centers in the pediatric space. But we continue to utilize that message from the FDA and continue to have support from them.

Speaker #3: But we continue to utilize, that message from the FDA and, and continue to have support from them. Yeah. Eduardo, when, when you when you when I've mentioned briefly, you know, our medical team, they have really reinvigorated both the fact that PEDMARC is the first and only approved product for the prevention of hearing loss as it relates to cisplatin.

Robert Andrade: Eduardo, when I mentioned briefly, our medical team, they have really reinvigorated both the fact that PEDMARC is the first and only approved product for the prevention of hearing loss as it relates to cisplatin. Also, understanding very well why cisplatin causes this hearing loss, what the uniqueness is of PEDMARC. We have started to see that bear fruit just in recent quarters, and we expect more to come. We have got a lot of enthusiasm, as Jeff mentioned, both in new pediatric patients and also in AYA. In AYA specifically, we have seen no compounded use of the product today.

Speaker #3: Also, understanding very well why cisplatin causes this hearing loss. What the uniqueness is of PEDMARC. And we've started to see though that bear fruit just in recent quarters and we expect more to come.

Speaker #3: And we've got a lot of enthusiasm as Jeff mentioned, both in new pediatric patients and also in AYA. And in AYA specifically, we have seen no compounded use of the product.

Speaker #3: Today.

Susan Logan-Nathan: Got it. That is really helpful. Going back to the EU, I think you mentioned the timeline for expanding. You mentioned you had started with, Norgine had started the work and found some good traction in the U.K. markets. Could you repeat the timeline for when you expect them to launch? You mentioned Italy, I think, and a few other countries. Just a little bit more clarity on that timeline again.

Speaker #7: Got it. That's, that's really helpful. And then, going back to the EU, I think you mentioned, the timeline for expanding. You mentioned you started with, Norgene had started the work and found some good traction with in the UK markets.

Speaker #7: Could you, repeat the, the timeline for when you expect them to launch? And you mentioned Italy, I think, and a few other countries. but yeah, just a little bit more clarity on that timeline again.

Robert Andrade: Sure. As a reminder, Norgine has the rights to all of the EU, Australia, and New Zealand. Principally, that first market is the U.K. They have also launched, and they have their first patient in Germany. There is not final pricing yet in Germany. There is only final pricing in the U.K. currently. The additional, as they call the EU5 markets on top of Germany, U.K., where you have Italy, Spain, and France, we expect a launch early next year with preparation later this year. The Nordic countries, Denmark, Norway, and additionally Switzerland, are starting to come on later this year and early next year. In summary, they are just getting going. They are just getting started, which we are very, very excited about.

Speaker #3: Sure. So, as a reminder, Norgene has the rights to all of the EU, Australia, and New Zealand. Principally, that first market is the UK.

Speaker #3: They have also launched and they have their first patient in Germany. but there is not final pricing yet in Germany. There's only final pricing in the UK.

Speaker #3: Currently, the additional, as they call the EU five markets on top of Germany and the UK, include Italy, Spain, and France. We expect a launch early next year, with preparation later this year.

Speaker #3: And the Nordic countries, Denmark, Norway, and additionally Switzerland, starting to come on later this year and early next year. So in summary, they're just

Speaker #7: Got it.

Speaker #3: getting going. They're just getting started, which we're very, very excited about.

Jeff Hackman: We are encouraged about the positive indications that we have seen in the early engagement.

Speaker #6: Yeah. We're encouraged about the positive indications that we've seen in the early engagement, so.

Susan Logan-Nathan: Got it. Do you have any visibility to that Germany pricing? That would trigger a milestone payment, is that correct?

Speaker #7: Got it. And do you have any visibility to that Germany pricing? I, that would trigger a milestone payment. Is that correct?

Jeff Hackman: That is a material milestone. We look forward to providing additional updates. What we do have is we have final pricing in the U.K., which well exceeded what we were anticipating, just a year ago. If we are consistent with that in Germany, we look forward to giving additional updates on that milestone.

Speaker #3: That That is a that is a material milestone. we look forward to providing additional updates. what we do have is we have, final pricing in the UK.

Speaker #3: Which I'm well exceeded, what we were anticipating, you know, just a year ago. And so if we remain consistent with that in Germany, we look forward to giving additional updates on that milestone.

Susan Logan-Nathan: Got it. Thanks for answering the question. We will move out from the quarter.

Speaker #7: Got Got it. Thanks for answering the question. And congrats on the quarter.

Operator: Thank you. I am currently showing no further questions at this time. I would like to turn the call back over to Jeff Hackman for closing remarks.

Speaker #1: Thank you. And I'm currently showing no further questions at this time. I'd like to turn the call back over to Jeff Hackman for closing remarks.

Jeff Hackman: Thank you. Thanks for your questions, everybody. I appreciate it and the continued engagement. As you heard today, we are so pleased with the momentum that we've been able to build in the first half of 2025. The revenue growth, the strong revenue growth that we've seen, is the key to really all of the milestones that we've been able to achieve. We remain focused on the discipline execution that we've talked about today, these strategic imperatives, and we're confident on the path ahead. Most importantly, I'll close the call. I never want to lose sight of the patients that we serve, especially the young people facing cancer treatment and the difference that our product, PEDMARC, can make in preserving their hearing and their quality of life. We appreciate your support. We look forward to updating you more on our continued progress in the quarters to come.

Speaker #3: Well, thank you. Thanks for your questions, everybody. I appreciate it and your continued engagement. As you heard today, we are so pleased with the momentum that we've been able to build in the first half of 2025.

Speaker #3: this, this, the revenue growth, the strong revenue growth that we've seen, the, the is the key to really, all of the milestones that we've been able to achieve.

Speaker #3: We remain focused, on the discipline execution that we've, we've talked about today, the strategic imperatives, and we're confident on the path ahead. So, you know, most importantly, I, I'll, I'll close the call.

Speaker #3: I never want to lose sight of the patients that we serve. Especially the young people facing cancer treatment. and the difference that, our product, PEDMARC, can make.

Speaker #3: In preserving their hearing and their quality of life. So we appreciate your support. We look forward to updating you more on our continued progress in the quarters to come.

Jeff Hackman: Thank you for participating today.

Speaker #3: and thank you for participating today.

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