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BioLineRx Ltd.
5/28/2024
Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first quarter 2024 financial results conference call. All participants are presently in a 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 first quarter 2024 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 6K. 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. For a full discussion of these risks and uncertainties, please review our annual report on Form 20F and our quarterly reports on Form 6K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Terland, Chief Executive Officer of BioLineRx.
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 Zevi, our Chief Financial Officer. In addition, Ella Serrani, our Chief Development Officer, will be joining the call for Q&A. I will begin with a brief update on the significant progress that we are making on our effects to launch, then turn the call over to Holly, who will go into our commercialization progress in more detail. I will then provide an update on our very promising pancreatic cancer and sickle cell disease programs. Finally, Mali will review our financial results. We will then open up the call to your questions. Let me begin with an Effecsta commercialization update. As we've noted previously, transplant centers, the end users of Effecsta are a well-defined group in the US. Approximately 80 of the 212 centers in the US perform roughly 85% of all transplant procedures. In this foundational year for Effecsta, we focused our efforts on these top centers and are making strong progress. To date, we have established formulary placement at centers that manage approximately 26% of all multiple myeloma-related transplant procedures in the top 80 centers, up from 20% last quarter. Importantly, we remain on track to achieve our 35% target by the end of the second quarter and 60% by the end of this year. As a result of this work, we saw steady growth in adoption in this, the first full quarter since launch. While it is very early in the launch, we are nonetheless pleased, not only with the sales trajectory that we are on, but on the progress that we continue to make, getting effects on more transplant center formularies and treatment protocols. Furthermore, feedback from transplant centers on the clinical benefits has been positive. They are experiencing effects as value firsthand, which simply put, is greater certainty. Greater certainty in collection, time to collection, and scheduling. This is a new era for multiple myeloma patients in transplant centers. Patients are more often older and increasingly receive quad induction therapy, which can increase mobilization risk. Additionally, transplant centers are seeing increased competition for aporesis chair time while experiencing staffing challenges. Greater certainty is the innovation that affects us providing this new era, and it is having a positive impact on patients as well as nursing and technical staffing. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma patients. Staying on the topic of stem cell mobilization, recall that last October we closed an exclusive license agreement with Gloria Biosciences for the development and commercialization of metixoportide across all indications in Asia. Gloria's IND for a small stem cell mobilization bridging study, a requirement for commercialization approval in China, by the Center for Drug Evaluation of the National Medical Products Administration in China. We expect that this study will commence with the first patient dosed 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 Boao region of China, in Singapore, and in Macau over the next few quarters. We estimate that Asia had over 51,000 reported cases of multiple myeloma, the largest number of cases globally. Stem cell mobilization is therefore a significant opportunity for both companies in the region. At this point, I'd like to turn the call over to Holly May, President of BioLine RxUS, for a more detailed review of our early effects to commercialization progress. Holly, please go ahead.
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