Fennec Pharmaceuticals Inc.

Good morning, ladies and gentlemen, and welcome to the Fennec Pharmaceuticals First Quarter 2020 for 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 call is being recorded. Now, I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade. Please go ahead.

Thank you, Operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceuticals First Quarter 2024 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 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. 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 United States 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. With that, I will now turn the call over to our Chief Executive Officer, Rusty Rykoff. Rusty?

Thank you, Robert, and good morning, everyone. On today's call, we'll detail our first quarter 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 progress that we're making with Petmark in the U.S. and abroad following the exclusive licensing agreement announcement we executed in March with Norgene to commercialize Petmark in Europe, Australia, and New Zealand. In the first quarter, Padmark delivered total net revenues of $25.4 million, including $18 million in licensing revenues from the Norgene transaction and $7.4 million in net Padmark product sales. Robert will further elaborate on the $18 million in the licensing revenue related to the Norgene transaction, but to be clear, we received $43.2 million from the transaction, which is reflected in our balance sheet as of March 31st, and cash of $51.2 million. We believe that a couple of things affected PEDMARC sales during the first quarter of this year. First, the public reminder that the US FDA issued to healthcare professional organizations in January stating that PEDMARC is not substitutable with other sodium thiosulfate products may have caused some unintended confusion in the marketplace. Initially, the professional affairs and stakeholder engagement staff at the FDA issued the potential health risks with substitution as a targeted outreach to the following organizations. Alliance for Pharmacy Compounding, American Academy of Pediatrics, American College of Apothecaries, American Hospital Association, American Pharmacists Association, American Society of Clinical Oncology, American Society of Health System Pharmacists, Association of American Cancer Institutes, Children's Hospital Association, Federation of American Hospitals, Hematology, Oncology Pharmacy Association, International Academy of Compounding Pharmacists, and Professional Compounding Centers of America. We believe that, in turn, some of these organizations communicated the FDA's safety message to their respective members. Recently, the Office of New Drugs at the FDA added the safety communication issued by CDAR's Professional Affairs and Stakeholders Engagement staff to PEDMARC's approval at the FDA page. It is clear that substitution post-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 PET marks. 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 STS products. Overexposure to sodium nitrate, which can lead to health risks, including methamoglobinemia. Sodium nitrate is co-packaged with sodium thiosulfate as a separate bile in some products, and it's not present in PedMart. Unfortunately, FENIX continues to see unlawful compounding of copies of PedMart with pediatric hospital pharmacies, unnecessarily putting costs in front of children's safety. The majority of these hospitals are affiliated with Children's Oncology Group, and thus far, the FDA's safety communication has not changed their behavior. PANF continues to diligently work with the FDA to address this issue. Additionally, prior to April 1st of this year, our GA code did not differentiate between PEDMARC and other formulations of STS. As a consequence, which we discussed in our call last quarter, there had been some confusion and some impact to the adaptation of PEDMARC. The good news is that as of April 1st, this issue has been fully resolved with CMS amending our JCO to specify PEDMARC. Now that this change is effective, we expect uptake to improve in the quarters to follow. Despite these acute challenges, we remain optimistic that it will be an exciting year for FANUC given the strong performance with PEDMARC in 2023, the first full fiscal year following our U.S. commercial launch. We're confident in our ability to navigate through these marketplace challenges to achieve our long-term objectives. Our outlook over the next few quarters will largely depend on our ability to successfully target the community hospitals and infusion centers, the treat in the outpatient setting, all the pediatric patients within our label, and the NCCM guidelines for adolescents and young adults. Fedmark continues to have broad and favorable payer coverage as evidenced by payer approval, approved U.S. prescription claims, with commercial insurance plans and Medicare Part D plans. Regarding our partnership with Norgene to commercialize PEDMARC-C in Europe, Australia, and New Zealand, efforts are well underway in these territories with a targeted launch date at fourth quarter this year. PEDMARC-C is the first and only approved therapy in the EU and UK for prevention of autotoxicity induced by cisplatin chemotherapy in patients one month to 18 years of age with localized non-metastatic solid tumors. As a reminder, under the terms of the licensing agreement, FANUC received approximately $43.2 million in upfront consideration and the potential of up to approximately $230 million in additional commercial and regulatory milestone payments and tiered royalties on net sales of FedMark C in the licensed territories up to the mid-20s. Norgene will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations. As we previously communicated, 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 autotoxicity. The terms provided us with many important benefits, including an upfront payment for the solidifying our balance sheet, driving economic terms, providing meaningful participation in the ex-US success of PEDMARC-C, With that, I will now turn the call over to Adrian, who will provide an update on our commercial strategy and operations. Adrian?