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BioLineRx Ltd.
8/15/2024
Ladies and gentlemen, thank you for standing by. Welcome to the BioLine Rx second quarter 2024 financial results conference call. All participants are presently in listen-only mode. Following management's formal presentation, instructions will be given for the question and answer session. I would now like to hand the call over 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 second 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. On the call today, we will have Phil Serlin, Chief Executive Officer of BioLineRx, Holly May, President of BioLineRxUSA, and Molly Zevi, our Chief Financial Officer. In addition, Ella Cerani, our Chief Development Officer, will be joining the call for Q&A. At this time, it is now my pleasure to turn the call over to Phil.
Thank you, John, and good morning, everyone, and thank you for joining us on today's call. Following our strong second quarter 2024 performance and the encouraging progress of our FEXTA launch to date, I wanted to highlight that today's BioLineRx is a fully integrated leader in stem cell mobilization with promising label expansion opportunities. This is a stark change from last year, and we are well-positioned deliver value to all of our stakeholders. I will begin with a brief update on the important progress that we are making on our effects to launch, then turn the call over to Holly. We'll go into our commercialization and lifecycle management progress in more detail. Molly will review our financial results, and then I will give a brief summary of our upcoming milestones. We will then open up the call for your questions. Let me begin with an effects to commercialization update. Last quarter, we set an important goal. We said that among our targeted top 80 transplant centers, by the end of the second quarter, we would secure formulary placement at institutions managing 35% of stem cell transplant procedures. And I'm happy to say that we surpassed this goal by June 30th, with formulary placement at institutions managing 37% of transplant procedures. We continue to make steady progress on this most important launch metric and remain on track to achieve our year-end target of 60%. Additionally, last quarter we achieved formulary status at two of the largest transplant centers in the U.S., and we also doubled the number of centers ordering product. We are pleased with this continued positive momentum in only the second full quarter of our commercialization program. Each week we learn about patients who have failed to collect enough stem cells on other mobilization agents, putting their path to transplant at risk. These patients were then given Afexa, and they achieved their stem cell mobilization goals, many in a single aporesis session. Transplant centers are seeing the tremendous efficacy that Afexa can provide in this new era for multiple myeloma patients, where patients more often are older and increasingly receive quad induction therapy, which can increase mobilization risk. In July, the FDA granted approval of an important quad therapy approach for transplant-eligible patients newly diagnosed multiple myeloma patients, including daratumumab and lenalidomide, which can negatively impact stem cell yield. The approval was based on the tremendous efficacy results seen in the Perseus trial, which compared the quad therapy to the leading triple therapy. The quad therapy lowered the risk of disease progression or death by 60%. Physicians have been treating patients with quad therapies prior to this approval. However, we believe that the data from this trial and the subsequent FDA approval will accelerate the process of quad therapy becoming the new standard of care, which, while beneficial to patients, has the potential to further increase the need for effect stuff. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma in this new era of care for patients. At this point, I'd like to turn the call over to Holly May, president of BioLine RxUS. to discuss our commercialization efforts and some of our lifecycle management initiatives. Holly, please go ahead.
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