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5/13/2025
and only mode. Later, we will conduct a question and answer session, and instructions on how to participate will be given at that time. As a reminder, today's conference call is being recorded. Now, I would like to turn the conference over to Phenix Chief Financial Officer Robert Andrade.
Thank you, Operator, and good morning, everyone. We appreciate you joining us today for Phenix Pharmaceutical's first quarter of 2025 Earnings Conference Call, during which we will review our financial results as well as provide a general business update. Joining me from FENIC this morning is our Chief Executive Officer and Board Member, Jeff Hackman. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ. from the results discussed in the forward-looking statements. Reference to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the U.S. Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days. And with that, I will now turn the call over to Jeff Hackman.
Thank you, Robert. And good morning, everyone. Wanted to thank you all for joining us today as we review our first quarter performance and share the outlook for the year ahead. I'm excited to share the details and highlights of our results for Q1 in 2025. So the alignment of our organization around clear commercial priorities to enhance field execution and support sustainable growth across key PEDMARC segments really began back in Q4 2024. Much of the work was implemented though in Q1 of this year. Therefore, Q1 was a quarter marked by a stronger strategic focus, disciplined execution, and a much more meaningful progress across all areas of our business. This was accomplished with really just a few critical activities. Let me go into those. The first is the development and implementation of a targeting model. a much more sophisticated model than the organization had in the past. It was data-driven and prescriber and practice lists to guide field execution and engagement were used. This was a critical step to better understand our business and our opportunities, especially given our expansion beyond pediatrics into the adolescent and young adult or AYA patient population. This targeting includes a structured tiering of Cisplatin prescribers nationally, prioritizing tiers like Tier 1 through 5, or those who treat high number of patients with Cisplatin, allowing us to focus on engagements in key academic institutions and large community practices where Pedmark can have the greatest clinical and commercial impact. As a result, the first quarter Tier 1 targets prescribed for Pedmark demonstrated early traction and validation of our focused engagement strategy. Some of the examples of these accounts are Tampa General Hospital in Florida, Rady Children's in San Diego, Huntsman's Cancer in Salt Lake, Zuni Comprehensive Health Center in New Mexico, and City of Hope, which is one of the largest advanced cancer centers in the country. These are just some accounts. and others that have begun to integrate pedmark into their treatment plans further validating its clinical utility and expanding patient access in real world settings as a part of these efforts we continue to be encouraged by the interest and adoption we see in the aya segment we've mentioned on prior calls that this opportunity for the segment is very significant in the u.s Fennec estimates that approximately 20,000 cisplatin chemotherapy patients are treated annually in the primary tumor types, thyroid cancer, breast cancer, germ cell, and testicular. The market potential in AYA is greater than the size of the pediatric market and has a favorable reimbursement profile via outpatient reimbursement. We also made significant strides on the medical front. increasing positive engagements with key opinion leaders and building momentum around awareness of the impact of cisplatin-induced ototoxicity. Our medical team also strengthened their clinical messaging based upon the data and interactions and new medical science liaisons or MSLs that joined our team and are already engaging with national KOLs. As an example of our cross-functional alignment, in late April, Fennec and our teams had an advisory board comprised of key opinion leaders from across the nation with specialties in medical oncology, urologic surgery, directors of pharmacy. This discussion focused on AYA treatment paths within academic institutions in these large community practices. During this meeting, Fennec's team gathered additional market insights to further inform and refine our executional excellence. moving forward. We're also actively working to further enhance our PHENIC HEARS patient support program to ensure a more seamless supportive experience for both providers and patients at every step of the PEDMARC journey. These upgrades designed to improve access, streamline reimbursement, and expand home nursing capabilities. PHENIC HEARS is critical for the healthcare provider's adoption and patient adherence. We experienced improvement in patient adherence throughout the quarter and we expect this to continue throughout the year as we bolster and support our offerings both with the HCPs and patients that we serve. By removing some of these friction points and delivering a very high touch experience across the treatment journey, we're not only supporting better care, but we're also helping to empower providers to identify and treat more eligible patients. This is essential and critical given the growing recognition of hearing loss, which is an essential part of cancer survivorship. As awareness increases, our program ensures providers are equipped with the right tools and support to proactively engage patients who may benefit from PEDMARC intervention helping us to advance both clinical access and also outcomes to care. Now I'd like to also address the commercial launch efforts and the progress that we're making with Pedmark outside the U.S. Following our exclusive licensing agreement that Fennec executed back in March 2024 with Norgene Pharmaceuticals, the product has now launched commercially in Germany and in the U.K. And just this past week, Norgene announced that the Scottish Medicine Consortium, or SMC, has accepted PEDMARC-C for use in Scotland. Collectively, these recent launches mark important steps in achieving Fennec's mission of expanding access to PEDMARC and PEDMARC-C to cancer patients at risk of hearing loss in the European Union and the UK. Also on the global front, the Investigator Initiated Trial in Japan, or STS-J01, evaluating PEDMARC was fully now enrolled as of October 2024. The clinical trial STS-J01 evaluates the efficacy and safety of PEDMARC in reducing autotoxicity induced by cisplatin in children and AYAs with localized solid tumors. The primary endpoint of this trial is to assess the frequency of hearing impairment at the end of treatment. Results of the trial are expected in the second half of 2025 with potential evaluation of both the registration and partnering or licensing of PEDMARC in Japan thereafter. Looking ahead, we are building a solid foundation with a laser-focused vision, as I mentioned, as we entered into 2025. This includes deepening our relationships with our key accounts, expanding adoption with new existing customers, and seeking evidence-based data generation through investigator-sponsored trials, or we call them ISTs. Based on our sharpened messaging, our strategic focus, and this discipline execution in the first quarter, we made some meaningful progress across all areas of our business. We're seeing positive momentum in our strategy to move healthcare providers from trial to adoption of PEDMARC. The strong momentum has continued in early Q2, and I look forward to continued progress and sharing those results with you throughout the year. With that, I'll turn it back over to Robert.
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