Fennec Pharmaceuticals Inc.

Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals' second quarter 2024 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 call is being recorded. Now, I'd 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 Pharmaceutical's second 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 is our newly appointed Chief Executive Officer and Board Member, Jeff Hackman. Jeff joined Fennec on August 5th and brings more than 30 years of commercial leadership. including oversight of more than 10 product launches across a wide range of therapeutic areas and markets. Importantly, Jeff has successfully commercialized products that are specifically relevant to the PEDMARC markets. Now, 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's website, www.fennecpharma.com, where it will be available for the next 30 days. And now it gives me pleasure to turn the call over to Jeff Hackman.

Thank you, Robert. And good morning, everyone. I'm incredibly excited to lead Fennec in this new role, and I look forward to working with this team to direct the organization through its continued growth efforts. Before I introduce myself, I would like to thank Rosti for his dedication and leadership since 2009. He's been critical not only to the success of PHENIC, but bringing a much needed therapy to the pediatric oncology population that was at risk for irreversible hearing loss. which can be a profound lifelong impact, as you know, on these patients. On behalf of everyone at Fennec, we're pleased we will be able to continue to benefit from Rosti's experience and knowledge as we enter into the next chapter. Let me talk a little bit about me. My tenure in oncology spans the last 12 years or so with companies like Sigma Tau, Baxaltis, Shire, and Yusa Pharma. where I was responsible for the U.S. commercial organizations and managing the company's product portfolios in multiple franchises, generating billions in revenues over those years. As Robert mentioned, I have specific experience commercializing oncology products that are specifically relevant to PEDMARC markets and in the pediatric oncology community, where I've spent a lot of time and I'm passionate about. From my very first early interactions with the team here at Fennec through my last week here, it's clear to me that we have access to an incredible pool of talent at Fennec. Fennec's dedication, expertise, and passion are evident, and I'm confident that together we can work to fill any gaps and address any needs to drive our organization forward. Now turning to our second quarter 2024 financial results. all of which were outlined in our earnings press release issued earlier this morning before the call. We will also discuss ongoing commercial launch efforts and the progress we're making with PEDMARC in the U.S. and abroad following exclusive licensing agreement announcement we executed in March with Norgene to commercialize PEDMARCSE in Europe, Australia, and New Zealand. In the second quarter, Pedmark delivered net revenues of 7.3 million. We believe there were several key milestones that we achieved recently that will enable us to accelerate patient access and build off the second quarter. In May, The Office of New Drugs at the FDA added a safety communication issued by CDER professional affairs and stakeholder engagement staff to PEDMARC's approval on the FDA page. Now it is clear that substitutions pose potential health risks. FENIC continues to diligently work with the FDA to address this issue. During the second quarter, notifications were sent outlining the FDA non-substitution status. Payer recipients included Medicare administrative contractors, Medicare Advantage, Manage Medicaid, and commercial payers. Provider recipients included all state oncology societies, the top 20 health systems, including children's hospitals, and more than 360 oncology practices. These are community-based or hospital-owned. Additionally, as of April 1st, our J-code was issued. and we fully resolved this with CMS, amending it to specify PEDMARC. Now that this change is affected, we are seeing uptake that we believe will continue to improve the quarters as we move forward. Further, and of great importance, the NCCN recently modified and updated their AYA guidelines for PEDMARC. The guidelines removed pediatric-specific wording and allowed for patients up to 39 years of age. And two, replaced cisplatin with platinum. We believe this allows PEDMARC to access a broader patient population within the autotoxicity prevention application. Now that the NCCN AYA guidelines have been modified, we've submitted PEDMARC data packages to the remaining targeted clinical drug compendia and anticipate that these updates to the compendia will be completed by the end of this quarter. So with all these recent milestones achieved, we remain optimistic and excited about the second half of the year for Phenic, given the foundation that we put into place the first 18 months of the launch. We're confident and are confident in our ability to navigate through these marketplace changes and to achieve long-term objectives. Our outlook for the next few quarters will largely depend on our ability to continue to make positive steps forward with these key institutions and successfully target community hospitals and infusion centers to treat the outpatient setting with these older patients within our label and the NCCN guidelines for adolescents and young adults. Our plans to do so include our sales force has expanded their activities and now are into the community centers that treat this AYA population that fall within our label. We believe that there are significantly more patients in this segment compared to the inpatient hospital treated pediatric population. Recently, we have administered to patients within this population, including tumor types such as testicular cancer, ovarian cancer, and head and neck cancer. We have successfully managed the reimbursement process with major health plans, such as Blue Cross Blue Shield, United, and Caremark. We continue to work diligently with senior managers to extend our reach into infusion center hours to accommodate the time that it takes to administer PetBark, which is six hours after splatin infusions. We will continue to build off our recent success in partnering with Orsini Specialty Pharmacy to help patients access Pedmark through Orsini's high-touch care model, the high-touch care model centers that provide personalized patient care. Now, regarding our partnership with NorGene to commercialize PEDMARC-C in Europe, Australia, and New Zealand, efforts continue to progress these territories and our targeted launch late Q4 2024, and this remains on track. As a reminder, under the terms of the licensing agreement, FENIC 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 the net sales of PEDMARCSE in these licensed territories up to the mid-20s. NORDGEN will be responsible for all commercialization activities in these licensed territories and will hold all marketing authorizations in these licensed territories. The next major milestone will be evaluated after the launch of Germany in Q4 of 2024. As we previously communicated, this partnership represents an important step for achieving our mission of expanding PEDMARXI to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity. These terms provided us with many important benefits, including an upfront payment, further solidifying our balance sheet, attractive economic terms, providing a meaningful participation in the ex-US success of PEDMARCSE, and an experienced partner to successfully launch PEDMARCSE in these licensed territories. So in closing, we continue to see promising opportunities for PEDMARC, including the steps we're taking to educate the marketplace along with executing on our commercial plans. We are looking forward to seeing the benefits of our actions in the coming months. So with that, I'm going to turn the call back over to Robert to go over the financials for the quarter.