BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx fourth quarter and full year 2023 financial results conference call. All participants are presently in the listen-only mode. Following management's formal presentation, instructions will be given for the question and answer session. I would now like to turn over the call to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.

Thank you, Operator. Welcome, everyone. Thank you for joining us on our fourth quarter and full year 2023 results conference call. Earlier today, we issued a press release, a copy of which is available in the investor relations section of our website. It was also filed as a six-day. I'd like to remind you that certain statements we make during the call will be forward-looking. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. Thank you, John, and good morning, everyone. And thank you for joining us on today's call. Joining me today are Holly May, President of BioLineRx USA,

and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A. I will begin with a brief update on our effects to launch, then turn the call over to Holly, who will go into the stem cell mobilization opportunity in more detail. I will then provide an update on our clinical programs in pancreatic cancer and sickle cell disease. Finally, Mali will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. Following the launch of our product in Stem Cell Mobilization just a few months ago in Q4, we expect substantially all of 2024 to continue to be a foundational period for the commercialization of Avexta, the first advancement in Stem Cell Mobilization in over a decade. Since FDA approval in September and the subsequent launch of Avexta in the U.S. in Q4, Early signs among payers in top tier stem cell transplant centers suggest that the Effecsta value proposition is resonating very well and evolving the stem cell mobilization treatment paradigm for patients with multiple myeloma. Recall that a key consideration when we elected to commercialize Effecsta independently in the U.S. was that end users of Effecsta transplant centers are well defined with approximately 80 of the 212 transplant centers performing the vast majority Approximately 85% of all procedures. Among this defined population, we have already secured formulary placement within these top 80 transplant centers managing approximately 20% of all stem cell transplant procedures at these institutions. Those familiar with commercial launches know that institutional pharmacy and therapeutic committees or PMTs Determine formulary status, the first step in center adoption and we anticipate that by year end we will have secured formulary placement within these top 80 transplant centers managing approximately 60% of all stem cell transplant procedures at these institutions. We are pleased with this progress and momentum which is right in line with our expectations. Our customer-facing teams have done a fantastic job working with centers to support them in developing protocols following P&T approvals, and we are very pleased by the number of clinical champions we are gaining every day. We have also received several repeat orders from multiple institutions. These centers were early adopters and moved quickly through the formulary process and subsequent design and adoption of new treatment protocols. Importantly, one highly regarded transplant center has already transitioned all of its patients to Apexva, as it recognizes the value of greater apheresis certainty. We are pleased by this early momentum, despite the fact that some customers have benefited from lower acquisition costs for generic Mozaville or Cloroxifor relative to reimbursement rates. This cost recovery advantage has been diminishing with time as reimbursement rates adjust to having generic Cloroxifor in the landscape. Meanwhile, transplantation centers are gaining the opportunity to experience the value effects it can bring to their centers that extend beyond drug costs, including the overall economic benefit of reducing apheresis days and the predictability regarding the number of apheresis days and the impact this reduction has on patients as well as nursing and technical staffing for apheresis, particularly in today's difficult hiring environment and the competition for apheresis chair times. Staying on the topic of stem cell mobilization, recall that in October we closed an exclusive license agreement with Gloria Biosciences for the development and commercialization of Metixifortide across all indications in Asia. In order to receive market authorization for Effexane China, a small bridging study is required. I'm pleased to share that the IND for this bridging study was filed in February with the Center for Drug Evaluation of the National Medical Products Administration. and we anticipate regulatory action in May. First patient dosed in this study is expected in the second half of this year. Additionally, for countries in Asia that do not require a bridging study, Gloria is making great progress. We anticipate commercialization to begin in the Bao region of China, in Singapore and in Macau over the next few quarters. We believe that commercialization in these territories will provide non-U.S. revenue in the second half of the year or early next year subject to regulatory approval. We estimate that Asia had over 51,000 reported cases of multiple myeloma, the largest number of cases globally, and stem cell mobilization for autologous transplantation represents a significant opportunity for both companies in the region. Needless to say, we are very pleased with how our Gloria collaboration is progressing. We are also pleased by the progress that we have made since our last quarterly update on our other Metixifortide programs, notably pancreatic cancer and sickle cell disease. I will provide updates on those programs in a moment, but at this point I'd like to turn the call over to Holly May, president of BioLineRx US, for a more detailed review of our early launch progress. Holly, please go ahead.