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8/14/2025
Good morning, ladies and gentlemen, and welcome to FinEx 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 FinEx Chief Financial Officer, 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. References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views 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. And with that, I will now turn the call over to Jeff Hackman.
Hey, thanks, Robert. Good morning, everyone. Thanks for joining the call today. Boy, it's hard to believe it's been one year since I stepped in into the CEO role here at Fennec. 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. 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. 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 FENIC 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. 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 and also is recognized by the National Comprehensive Cancer Network, or NCCN, with a two-way recommendation for use in adolescent and young adult patients. 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. 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. 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. And to that end, I'm pleased to share that a large national oncology group of providers recently added Pedmark 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, and we're 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. 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'm 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 CIO in pediatric 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 a high-quality care for patients receiving oral and IV therapies and 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. 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's journey, including ENTs, audiologists, nurses, and pharmacists. These groups are now engaging with FENIC and PEDMARC, and we're seeing the benefit of this multidisciplinary support in day-to-day clinical practices. 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. 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. The strengthening of our Fennec HEERS patient assistance program has been central to this work. We've seen quarter over quarter growth in enrollment in Fennec HEERS programs and the newly revamped offerings that we're delivering, 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. 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're 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's a really important symbolic reminder of our mission, which is to help more patients be able to hear their own remission bells. 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. 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'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. I'm incredibly proud of the Fennec team and encouraged by the continued growth that we're seeing, which reinforces our belief in the scalability of this model and the growing demand for PEDMARC across these key markets. With that, I'll now turn it back over to Robert.
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