BioLineRx(US:BLRX)2024-03-26 15:38Financial Data and Key Metrics Changes - Total revenues for the year ended December 31, 2023, were $4.8 million compared to no revenues for the year ended December 31, 2022, primarily reflecting a portion of the upfront payment from the Gloria Biosciences license agreement [42] - Research and development expenses for the year ended December 31, 2023, were $12.5 million, down from $17.6 million in 2022, due to lower expenses related to motixafortide and AGI-134 completion [43] - Net loss for the year ended December 31, 2023, was $60.6 million compared to $25 million in 2022, including $17.8 million of non-cash expenses [46] Business Line Data and Key Metrics Changes - Cost of revenues for the year ended December 31, 2023, amounted to $3.7 million, reflecting a $3 million sublicense fee for APHEXDA and amortization of an intangible asset [41] - Sales and marketing expenses for the year ended December 31, 2023, were $25.3 million, significantly up from $6.5 million in 2022, driven by pre-commercialization and commercialization activities related to motixafortide [44] Market Data and Key Metrics Changes - The company has established access for 95% of covered lives across a mix of both commercial and government payers for APHEXDA [24] - The company estimates that Asia had over 51,000 reported cases of multiple myeloma, representing a significant opportunity for stem cell mobilization [16] Company Strategy and Development Direction - The company aims to continue the commercialization of APHEXDA, with expectations to secure formulary placement in top transplant centers managing approximately 60% of all procedures by year-end [11][22] - The company is also focusing on expanding its presence in Asia through collaborations, including a bridging study for APHEXDA in China [14][15] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the early momentum of APHEXDA's launch, noting positive feedback from transplant centers and payers [12][26] - The company anticipates significant opportunities in pancreatic cancer and sickle cell disease, with ongoing clinical trials expected to yield data in the second half of the year [38][50] Other Important Information - The company had cash, cash equivalents, and short-term bank deposits of $43 million as of December 31, 2023, which is expected to fund operations into 2025 [47] - The company is in discussions with multiple stakeholders regarding the potential use of motixafortide in gene therapy processes [58] Q&A Session Summary Question: Understanding the formulary process for APHEXDA - Management explained that formulary acceptance is critical and involves a process that can take several months, requiring education and protocol development at transplant centers [54][56] Question: Gene therapy opportunities and collaborations - Management confirmed ongoing discussions with companies and institutions regarding the use of motixafortide in gene therapy, particularly for those requiring CD34+ stem cells [58][59]