Fennec Pharmaceuticals Inc.

Good morning, ladies and gentlemen, and welcome to the Fennec pharmaceutical second quarter 2023 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. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. As a reminder, today's conference call is being recorded. Now, I would like to turn the conference over to Fenex Chief Financial Officer, Robert Andrade.

Thank you, Operator, and good morning, everyone. We are delighted that you could join us today for Fennec Pharmaceutical's second quarter 2023 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 is Rusty Rykov, our Chief Executive Officer, and our newly appointed Chief Operating Officer, Adrian Haig. 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 risk 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 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 this call over to Rusty Rykov.

Thank you, Robert, and good morning, everyone. We'll be discussing our recent progress as we have achieved many significant milestones over the past several months. The focus of today's call is to review updates on the ongoing launch efforts underway for Petmark in the U.S. and discuss our global opportunities, including the recent approval in Europe. Further, we'll detail our second quarter financial results, all of which were outlined in our earnings press release issued this morning prior to this call. As a reminder, PEDMARC is the first and only FDA-approved therapy to reduce the risk of cisplatin-induced hearing loss in pediatric patients one month of age and older with localized non-metastatic solid tumors. The availability of PEDMARC is ushered in a critical breakthrough for the pediatric oncology community, which was enthusiastically awaiting a rigorously tested and FDA-approved option to safely increase the potential long-term quality of life of these young patients. In June, we announced PEDMARC-C was granted marketing authorization by the European Commission. PEDMARC-C is the first and only approved therapy in the EU for prevention of hearing loss induced by cisplatin chemotherapy in patients one month to 18 years of age with localized non-metastatic solid tumors. Further, FEDMARC-C was granted pediatric use marketing authorization, PUMA, which includes eight years plus two years of data and market protection. In terms of our commercial strategy, we're pleased to share the results of the second quarter as we believe they underscore the growth potential of FEDMARC. We remain focused on executing the following, establishing FEDMARC as the necessary complement agent when prescribing a cisplatin-based therapy for a child with localized non-metastatic solid tumor, minimizing the barriers to access and ensuring rapid responses to product questions, and establishing FANUC as a premier partner of choice among the pediatric oncology community. To help address these goals, we have established a best-in-class patient services and support offering called FANUC Hears, which is a comprehensive single-source program designed to connect bedmark patients to both patient financial and product access support. In addition, we have built out a strong commercial team to execute US marketing, distribution, access, and launch of Pedmark with a sales team that is highly focused on targeting the approximately 200 pediatric hospital centers, including COG, NCI, and NCCN institutions across the US that drive 80% of cisplatin use. More specifically, we're pleased with the second quarter's double-digit growth in new pediatric hospital centers prescribing Penmark and the consistent repeat orders from existing accounts. Further, we have had recent success in larger academic centers, including formulary approvals early in the third quarter at major pediatric hospital centers. As a reminder, early adoption has come from both major academic centers and regional practices. More recently, we have had adoption coming from some of the most recognized pediatric centers of excellence. Geographically, all of our territories have seen HCPs prescribing PEDMARC, and we have seen highly encouraging adoption within our target accounts that are increasing over time. In terms of patients, we have seen patient utilization across several tumor types, including hepatoblastoma, osteosarcoma, and germ cell tumors. Further, given our broad In favorable player coverage and streamlined reimbursement process, we have been successful in securing coverage for prescribed patients. So we're pleased that the effort and execution of the team is starting to become evident in the 98% net revenue growth experienced in the second quarter. We're continuing to execute against our strategic launch plans and are confident in our disciplined and targeted approach to building share within the US market. With regard to expanding in Europe, We announced in June the marketing authorization for Pedmark, which will be marketed as Pedmark C. Pedmark C will be the first and only treatment approval in the European Union to address this area of significant unmet medical needs. We continue to evaluate the best commercial pathway for the company in Europe and the rest of the world, either go it alone or with a partner or both. Whatever pathway we select, we see Europe as another significant opportunity to create shareholder value. Finally, as announced today, I am very pleased to have Adrian Haake join the executive management team of Fennec as chief operating officer. Adrian has been a major contributor to Fennec's success since joining the board in 2014 and is part of the Fennec family. We are fortunate to have him available to help us at this pivotal stage in the commercial evolution of FENIC. Adrian comes to us from PTC Therapeutics, where his last role was Senior Vice President and Head of International. Prior to that, Adrian worked with our chairman, Dr. Khalid Islam, as Chief Operating Officer at Gentium, where he built and managed Gentium's commercial and medical affairs organization, and was also responsible for business development, playing a pivotal role in the sale of Gentium to Jazz Pharmaceuticals for one billion. Adrian, it's great to have you with us on this call. Can you give us a brief overview of the opportunity you see for FENAC given your new role?