• Total Revenue: $4.9 million for Q3 2024, compared to no revenue in Q3 2023.
• Cost of Revenue: $0.8 million for Q3 2024, with no cost recorded in Q3 2023.
• Research and Development Expenses: $2.6 million for Q3 2024, down from $2.7 million in Q3 2023.
• Sales and Marketing Expenses: $5.5 million for Q3 2024, down from $8.1 million in Q3 2023.
• General and Administrative Expenses: $1.4 million for Q3 2024, slightly down from $1.5 million in Q3 2023.
• Net Loss: $5.8 million for Q3 2024, compared to $16 million in Q3 2023.
• Cash, Cash Equivalents, and Short-term Bank Deposits: $29.2 million as of September 30, 2024.
• Market Share of APHEXDA: Achieved 10% market share of total CXCR4 inhibitor usage in the US by end of Q3 2024.

• Warning! GuruFocus has detected 5 Warning Signs with BLRX.

Release Date: November 25, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• BioLine Rx Ltd (NASDAQ:BLRX) executed a significant licensing agreement with Ayrmid Ltd., providing a $10 million upfront payment and potential commercial milestones of $87 million.
• The company received a $9 million equity investment from Highbridge Capital, aiding in debt repayment and restructuring with BlackRock on favorable terms.
• The licensing agreement with Ayrmid Ltd. allows BioLine Rx Ltd (NASDAQ:BLRX) to reduce cash burn significantly and extend its cash runway into 2026.
• BioLine Rx Ltd (NASDAQ:BLRX) plans to focus on drug development, particularly in oncology and rare diseases, leveraging its expertise in clinical development.
• APHEXDA, BioLine Rx Ltd (NASDAQ:BLRX)'s stem cell mobilization agent, achieved a 10% market share in the US, with strong growth expected through Gamida Cell's commercial efforts.

Negative Points

• BioLine Rx Ltd (NASDAQ:BLRX) is shutting down its US commercial operations, which may lead to transitional challenges.
• The company faces uncertainties in the development of motixafortide for pancreatic cancer, with potential delays in trial enrollment and data availability.
• There is a risk of potential sales lags or dips during the integration of APHEXDA into Gamida Cell's program, especially with insurance resets.
• BioLine Rx Ltd (NASDAQ:BLRX) is reliant on partnerships for the advancement of its PDAC program, which may limit its control over the development process.
• The company's future revenue from China remains uncertain, with no clear timeline for when sales might commence.

Q & A Highlights

Q: Did you say potential in-licensing of one asset in '25 and one in '26? A: Yes, that's our plan. We have a number of assets that we're already looking at. Business development doesn't always go exactly according to plan, but overall, that's our plan. - Philip Serlin, CEO

Q: How do you mix the pancreatic program with the potential for motixafortide in additional solid tumor indications, and can you discuss the level of maturity of these discussions? A: We view PDAC as a prototype for other solid tumors. We are not investing more in PDAC currently, as we have ongoing collaborations at low cost. We hope for interim data in 2026, which could lead to business development discussions. - Philip Serlin, CEO

Q: Regarding the Ayrmid APHEXDA sale, do they have any potential option on the solid tumor program? A: They do not have any option on the solid tumor program. - Philip Serlin, CEO

Q: Can you provide some color on where you view the company's core competencies as we wait to hear more about the addition of potential assets to your pipeline? A: We are returning to our roots as an Israeli-based development company with a highly experienced team. We have capabilities in regulatory affairs, CMC, quality assurance, clinical operations, and preclinical development. We also have cash flows from partnerships and ongoing trials in PDAC at minimal cost. - Philip Serlin, CEO

Q: Looking at the 2025 expenses, you indicated a 70% reduction in spend next year. Is it fair to assume this is mostly from sales and marketing expenses? A: It's more than just sales and marketing. We expect a decrease in G&A expenses as well. We aim to be lean and efficient, focusing development in Israel, which is a low-cost environment. - Philip Serlin, CEO

Q: On the R&D side, should we think of that continuing at the same level, and what are those obligations? A: We have some post-marketing commitments with the FDA and PDAC commitments, but these are minimal. Most of our R&D spend will be on new projects as we bring them in. - Philip Serlin, CEO

Q: As we look at potentially a pivotal trial in PDAC, would that be taken over by partners? A: Yes, we believe partnering would be the best path forward for a trial of this size in solid tumors, especially with robust Phase IIb data. - Philip Serlin, CEO

Q: On China, when would you expect the first revenues to show up from that region? A: It's hard to say, but we hope for revenues in 2025. We don't have full control over Gloria's actions, but we are in regular contact with them. - Philip Serlin, CEO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.