Analyst Conference Summary

biotechnology

conference date: November 20, 2023
for quarter ending: September 30, 2023 (3rd quarter, Q3)

Forward-looking statements

Overview: Aphexda approved by FDA in September 2023.

Basic data (GAAP):

Revenue was $0 million, flat sequentially from $0 million and flat from $0 million year-earlier.

Net income was negative $16.0 million, up sequentially from negative $18.5 million, and down from negative $6.8 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.02, up sequentially from negative $0.02 and down from negative $0.01 year-earlier.

Note: American Depository Shares traded on NASDAQ appear to represent 15 ordinary shares in the Israeli company SEC filings. The EPS listed on press releases seems to correspond to ordinary shares, so would be 15X if listed for ADS shares.

Guidance:

Funded into 2025.

Conference Highlights:

Philip Serlin, CEO of BioLineRx, said "FDA approval of Aphexda in September was a transformative event for the company, and our U.S. commercial team is now working with payers and providers to make this important innovation available to patients. We were pleased that Aphexda was recently added to the NCCN guidelines, and we believe that as centers adjust their protocols to include and gain experience with Aphexda, transplant teams will gain a deep appreciation for the efficiencies that it can provide, and more importantly, the improved treatment journey patients experience as they navigate their essential transplant process."

Launch activities for Aphexda for stem cell mobilization in multiple myeloma are underway. Currently about 8,000 stem cell transplants for multiple myeloma currently occur annually. Many patients have trouble getting their stem cells collected. Aphexda is a highly diffentiated, second generation mobilization agent. Competition is the first generation agent and its biosimilars. $5,900 price per vial set for Aphexda, which is significantly more than the generics, but still saves costs given its efficacy. Aphexda now included in NCCN guideline. ASTCT also working on updating its guidelines.

The FDA approved Aphexda, in combination with filgrastim, for stem cell mobilization in patients with myeloma, in September 2023. More data will be presented at ASH on December 10.

In Q3 agreed with Gloria Biosciences to partner Aphexda in China, beginning with a bridging study. Already received $15 million, more milestones and royalties ahead. Gloria also made a $14.6 million equity investment. Data from the Phase 1 study at Columbia University were positive and presented at AACR in Q3 2023. That study is now planned for expansion to a randomized trial to start within a few months.

Gloria is also partnering for the study of Aphexa for first-line pancreatic cancer, in combination with a PD-1 inhbitor. In Q3 2023 presented Phase 2 data at AACR.

In Q3 2023, BiolineRX began Phase 1 ernollment at Washington University for Aphexda for stem cell mobilization in sickle cell gene therapies.

The other item in the pipeline is AGI-134, a solid tumor immunotherapy. The positive results of a Phase 1/2a study had been announced in Q4 2022.

Cash and equivalents ended at $26 million.

Operating expenses of $12.4 million consisted of: R&D $2.7 million; sales/marketing $8.1 million; G&A $1.5 million. Non-operating expense $3.1 million. Finanical Expense $0.5 million.

Q&A, selective summary:

Aphexda launch color? Much of what we are doing is as expected. About 80 transplant doctors make do about 80% of the transplants. Decision makers like the efficiency of our product. They also like our strong efficacy data. Patient experience is also an important point.

Plans for other indications? Thinking about add-on indications, cannot speak to off-label utilization. Focus is on what we announced, gene therapy and sickle cell.

In pancreatic cancer, if continued positive data we could continue development ourselves or partner with another company. Believes could indicate whether it could work with other cancers.

How quickly do guidelines get changed into practice? From a payer perspective, pretty much immediately.

Vertex sickle cell therapy? I was the chief commercial officer at a gene therapy company, so: want to solve for entire patient journey. Stem cell mobilization is especially important for sickle cell, a higher number of cells than for multiple myeloma. Current regimen requires multiple collection cycles. We hope we can show better mobilization and so reduce the number of cycles.

Cash? Including the $30 million from the deals, we would have in excess of $50 million on a proforma basis. We also have a debt facility available to us. In ADSs we have about 70 million shares (15x for ordinary shares).

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