Fennec Pharmaceuticals Inc.

Good morning, ladies and gentlemen, and welcome to the Fennec Pharmaceuticals fourth quarter and full year 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. 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. You may begin.

Thank you, Operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceuticals' fourth quarter and full year 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 are Rusty Rykov, our Chief Executive Officer, and Adrian Haig, 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 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 website, www.fennecpharma.com, where it will be available for the next 30 days. And now I will turn the call over to Rusty Rykoff.

Rusty? Thank you, Robert, and good morning, everyone. On today's call, we'll detail our fourth quarter and full year 2023 financial results, all of which were outlined in our earnings press release issued this morning prior to this call. We'll also discuss ongoing commercial launch efforts and the progress that we're making with PEDMARC in the US and provide details on the exclusive licensing agreement we announced on Monday with Norgene to commercialize PEDMARC-C in Europe, Australia, and New Zealand. As you may recall, we announced preliminary and audited fourth quarter and full year 2023 net revenues at the end of February, and we're pleased to report that PEDMARC delivered fourth quarter revenues of approximately $9 million This brings our full year 2023 net revenues of approximately $21 million. It was an exciting year for Fennec, given the strong performance with FedMark in the full fiscal year following its U.S. commercial launch. We're pleased with our execution against strategic plans and our momentum in 2023, which sets us the stage for further success in 2024 and beyond. We continue to be very encouraged with the progress we've made and we're even prouder of the work that is underway to sustain this momentum throughout 24 and beyond. Earlier this year, we announced that the FDA issued a public communication that is aware that some providers may be preparing autosodium thiosulfate products for patient use in place of Pedmark, including diluting STS products approved for auto uses to match the strength of Pedmark. The FDA reminded healthcare providers that it stated in Pedmark's prescribing information Pedmark is not substitutable with other sodium thiosulfate products. The FDA stated that such substitutions pose potential health risks, including potassium chloride exposure, which at high doses can lead to increased risk of acute cardiac events and other serious adverse reactions. Potassium chloride is not present in Pedmark. Overexposure to boric acid can cause health risks, including headache, hypothermia, restlessness, weariness, renal injury, dermatitis, alopecia, anorexia, and indigestion. Although Pedmark also contains boric acid, it is at a lower concentration than other SDS products. Overexposure to sodium nitrate, which can lead to health risks, including metemoglobinemia, Sodium nitrate is co-packaged with sodium thiosulfate as a separate bio-insulin product. It is not present in PEDMARC. The public communication was issued by the FDA's professional affairs and stakeholder engagement staff with the Center for Drug Evaluation and Research Office of Communications. We're pleased with the FDA reminder to providers of this issue which supports our educational efforts in establishing PEDMARC as a necessary complement agent when prescribing a cisplatin-based therapy for appropriate patients with a localized non-metastatic cell tumor. To that end, earlier this month, we sponsored an educational program with MedSafety Board, a subsidiary of the Institute for Safe Medication Practices, or ISMP, in which expert faculty, Rita Ju and Dr. North, for reducing the risk of cisplatin-induced autotoxicity in pediatric patients. Regarding our commercial efforts, our sales force continues to target approximately 200 pediatric hospital centers, including COG, NCI, and NCCI institutions across the U.S. that drive 80% of pediatric cisplatin use. We're also continuing to build upon our commercial momentum through expanding the prescriber base to the community, increasing the utilization of the recent endorsement from the NCCN for PEDMARC in the adolescent and young adult AYA patient population. To be clear, our FDA indication is pediatric and our commercial teams are only promoting our FDA indication. PEDMARC 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 Fedmark patients approximately 50% are commercially insured with another 50% insured through government-sponsored programs. With regards to our evaluation of the best commercial path in Europe, we were pleased to announce on Monday that Fennec has entered into an exclusive licensing agreement with Norgene, a leading European specialty pharmaceutical company under which Norgene will commercialize Fedmarks in Europe, Australia, and New Zealand. FEDMARC is the first and only approved therapy in the EU and UK for the prevention of autotoxicity induced by cisplatin chemotherapy in patients 1 month to 18 years of age with localized non-metastatic solid tumors. Under the terms of the licensing agreement, FANUC received approximately 43 million U.S. dollars in upfront consideration and the potential for up to approximately $230 million in additional commercial and regulatory milestone payments and tiered royalties on net sales of Bedmark C in the licensed territories up to the mid-20s. Norgina will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations. This partnership represents an important step in achieving our mission of expanding PEDMARC-C to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity. From a deal perspective, the terms provided us with many important benefits, including an upfront payment for the solidified in our balance sheet, attractive economic terms providing meaningful participation in the ex-U.S. success of PEDMARC-C, and an experienced partner to successfully launch PEDMARC-C in the licensed territory. In closing, I want to reiterate that the focus of our commercial strategy remains on executing the following, establishing FedMark as a necessary complement agent when prescribing a cisplatin-based therapy for appropriate patients with localized non-metastatic solid tumors, minimizing the barriers to access and ensuring rapid responses to product questions and inquiries, and establishing FedMark as the partner of choice in the oncology inpatient and community setting. With that, I will now turn the call over to Adrian, who will provide an update on our commercial strategy and operations.