Fennec Pharmaceuticals Inc.

good morning ladies and gentlemen and welcome to fennec pharmaceuticals third quarter 2023 earnings earnings and corporate update conference call at this time all participants are on a listen-only mode later we will conduct a question and answer session and instructions on how to participate will be given at that time as a reminder today's conference is being recorded now i would like to turn the conference over to fennec chief financial officer robert andrade please go ahead thank you operator and good morning everyone

We appreciate you joining us today for Fennec Pharmaceuticals' third 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 Adrian Hay, our Chief Operating Officer. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. 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 US 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 Rusty Rykoff.

Thank you, Robert, and good morning, everyone. The focus of today's call is to review updates on the ongoing commercial launch efforts underway for Padmark in the United States and review our global opportunities, including the recent approval in the UK and Europe. Further, we will detail our third quarter 2023 financial results, all of which were outlined in our earnings press release issued this morning prior to this call. We're very pleased to report that Fedmark delivered strong third quarter revenues of $6.5 million, a 96% increase over the second quarter of 2023. Further, this represents more than tripling our revenue since Q1 2023 from $1.7 million reported in Q1. We continue to be very encouraged with the progress we've made with Fedmark launch to date. And we are even prouder of the work that is underway to sustain this momentum throughout the remainder of 23 and as we head into 24. As a reminder, PEDMARC was approved by the FDA in September of 22. It 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. We launched Spedmark in the US in October, 2022. So we're just marked on our one year anniversary since Spedmark became commercially available. We're very proud of the team's ongoing commercial progress and our enthusiasm for Spedmark and passion for supporting the pediatrician college community continues to grow. In fact, the team had a busy fall season, engaging in robust discussions with key opinion leaders on the issue of cisplatin-induced autotoxicity. We recently attended the International Society of Pediatric Oncology Annual Meeting, the Connective Tissue Oncology Society Annual Meeting, the HealthConnect Partners 2023 Fall Hospital Pharmacy Conference, and the Association of Pediatric Hematology Oncology Nurses Annual Meeting, where we saw and heard firsthand about the importance of our work. These conferences followed on the heels of an event where we sponsored the Hillsdale College Pediatric Cancer Awareness Day football game, in which proceeds from the day went to support multiple organizations engaged in the fight against childhood cancer. These are just a few examples of how we are continuing to build strong relationships within the community. In terms of commercial efforts to establish PEDMARC as a necessary complementary agent when prescribing a cisplatin-based therapy for a child with a localized non-metastatic solid tumor, Our sales force is currently targeting 200 pediatric hospital centers, including COG, NCI, and NCM institutions across the US. They drive 80% of cisplatin use. Based on these efforts, we estimated approximately 20% have written a bedmark prescription. In fact, we believe that some of the leading centers have already prescribed more than 25% of eligible patients under their care. We're highly encouraged by the third quarter's double-digit growth in new pediatric hospital centers prescribing PEDMARC, and with the consistent repeat orders from existing accounts. Further, we continue to see success in large academic centers, including continued formulary approvals at several major pediatric hospital centers in the third quarter. 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 utilization across several tumor types, including hepatoblastoma, osteosarcoma, and germ cell tumors. MedMart also continues to have broad and favorable payer coverage as evidenced by payer-approved U.S. prescription claims with commercial insurance plans and Medicare Part D plans. As a reminder, we estimate among current PEDMARC patients, approximately 50% are commercially insured, with another 50% insured through government-sponsored programs. The remainder have no or limited insurance coverage and may be eligible to receive PEDMARC at no cost to them under our patient assistance program, FANIC HEARS, which is a comprehensive single-source program designed to connect PEDMARC patients to both patient financial and product access support. With regard to expanding in Europe, we announced in June the email approval of PEDMARC, which will be marketed under the name PEDMARC-C. PEDMARC-C will be the first and only treatment approved in the European Union to address this area of significant medical need. Further, in October, the Medicines and Healthcare Products Regulatory Agency, or MHRA, in the UK approved PEDMARC-C for the same indication. Following up on our strong UK Key opinion leader relationships. Earlier this fall, we presented background and data on PEDMARC-C at a hearing therapeutic summit organized by RNID with the UCL Ear Institute and UCLH Biomedical Research Center in London. 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. Whatever pathway we select, we see Europe as another significant opportunity to create shareholder value. In closing, I want to reiterate the focus of our commercial strategy remains on executing the following. Establishing PEDMARC is a necessary complement agent when prescribing cisplatin-based therapy for a child with localized nonmetastatic solid tumor. Minimizing the barriers to access and rapid responses to product questions. and establishing FANUC as the premier partner of choice among the pediatric oncology community. With that, I will now turn the call over to Adrian, who has been on the board of FANUC since 2014 and joined the executive management team of FANUC in August of this year as chief operating officer. Adrian will share his observations and opportunities after his first 100 days on the job. Adrian, over to you.