BioLineRx (BLRX) Q2 2024 earnings summary

Executive summary

• Achieved APHEXDA formulary placement at centers managing 37% of U.S. stem cell transplants, surpassing the Q2 2024 goal and on track for 60% by year-end.

• Doubled the number of centers ordering APHEXDA quarter-over-quarter, driving 100% sequential net revenue growth.

• APHEXDA showed strong efficacy in patients failing other mobilization agents, supporting adoption amid evolving multiple myeloma standards.

• FDA approval of quad therapy for multiple myeloma expected to increase APHEXDA demand due to higher mobilization risk.

• Entered clinical trial agreement with St. Jude for gene therapies in sickle cell disease; ongoing collaborations in multiple myeloma and pancreatic cancer.

Financial highlights

• Q2 2024 revenue was $5.4 million, with $3.6 million from Gloria Biosciences license and $1.8 million from APHEXDA U.S. sales; no revenue in Q2 2023.

• Cost of revenue was $0.9 million, mainly from amortization, royalties, and cost of goods sold.

• Net income was $0.5 million, reversing a net loss of $18.5 million in Q2 2023, aided by $7.8 million in non-operating income from warrant revaluation.

• R&D expenses decreased to $2.2 million from $3 million year-over-year; sales and marketing rose to $6.4 million from $5.6 million; G&A increased to $1.6 million from $1.3 million.

• Cash and equivalents totaled $40.1 million as of June 30, 2024, sufficient to fund operations into 2025.

Outlook and guidance

• On track to achieve year-end target of 60% formulary placement at U.S. transplant centers.

• Anticipates first patient dosed in St. Jude sickle cell gene therapy trial in September 2024; initial data in 2025.

• Early data from Wash U sickle cell trial expected in H2 2024.

• Gloria Biosciences to initiate bridging study for APHEXDA approval in China in H2 2024; pivotal trial initiation expected H2 2024.

• Phase II-b pancreatic cancer study with Gloria to start in 2025; CheMo4METPANC trial to be fully enrolled by 2027.