Analyst Conference Summary

biotechnology

conference date: August 15, 2024
for quarter ending: June 30, 2024 (second quarter, Q2)

Forward-looking statements

Overview: Revenue from Aphexda ramping, but slowly.

Basic data (GAAP):

Revenue was $5.4 million, down sequentially from $6.9 million, and up from $0 year-earlier.

Net income was $0.5 million, up sequentially from negative $0.7 million, up from negative $18.5 million year-earlier.

Earnings per share, diluted, (EPS) was $0.00, flat sequentially from $0.00, and up from negative $0.02 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:

Cash runway into 2025.

Conference Highlights:

Philip Serlin, CEO of BioLineRx, said "Among our targeted top 80 transplant centers, we've secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, surpassing our stated goal. Additionally, we doubled the number of transplant centers ordering Aphexda during the second quarter, which is a strong leading indicator and, we believe, reflects centers' growing recognition of the value that Aphexda offers relative to other mobilization agents. Our goal is to achieve formulary placement at institutions representing approximately 60% of procedures by the end of year, which will support continued revenue growth and ease burdens on patients, caregivers, and transplant centers." Label expansion opportunities are available. Achieved formulary status at 2 of the largest transplant centers in the U.S. Aphexda is showing tremendous efficacy in a competitive market. Health economics presentations are showing why providers should shift to Aphexda, including with the new quad therapies for multiple myeloma.

Evaluating Aphexda (motixafortide) for supporting sickle cell gene therapies in a Phase 1 trial, with data in 2024. Continues Phase 2 programs in pancreatic cancer combined with a PD-1 inhibitor, with positive preliminary biopsy data presente at ASCO in June 2024.

Revenue consisted of $1.8 million for Aphexda, up sequentially from $0.9 million, and $3.6 million from Gloria Biosciences for the new license agreement and a milestone payment.

Launch activities for Aphexda for stem cell mobilization in multiple myeloma continue. 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. In Q2 2024, among the top 80 transplant centers, secured formulary placement at institutions representing ~37% of stem cell transplant procedures performed and is on track to reach stated goal of ~60% by year-end 2024.

In Q2 2024 accessed $20 million from the BlackRock lending agreement and completed a $6 million equity offering.

In Q3 agreed with Gloria Biosciences to partner Aphexda in China, beginning with a bridging study. In February an IND was filed for the bridging study needed for the Asian approval, which is expected to begin in 2H 2024. A few Asian nations do not require the study to proceed and revenue could begin in 2H 2024. China has the largest number of multiple myeloma cases of any nation.

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. Pilot phase was successful, with 7 of 11 patients getting partial responses. 3 more had disease control. Columbia University and Regeneron with BiolinxRx are expanding into a randomized Phase 2b study, which had its first patient dosed in February 2024. Early Phase 2 data was presented on June 1, 2024 at ASCO. Gloria also partnering in pancreatic cancer.

In Q3 2024 announced collaboration study with St. Jude Children's Research Hospital for Aphexda for mobilization of stem cells for sickle cell gene therapy, with first dose in September 2024. In Q3 2023, BiolineRX began Phase 1 enrollment at Washington University for Aphexda for stem cell mobilization in sickle cell gene therapies, with preliminary results expected in 2024. The current cell collection therapies are less than optimal for sickle cell.

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 $40.1 million, up sequentially from $28.2 million. Had about $8 million in debt.

Operating expenses consisted of: Cost of sales $0.9 million; R&D $2.2 million; sales/marketing $6.4 million; G&A $1.6 million. Operating loss $5.8 million. Other income $7.8 million. Finanical Expense net $1.5 million.

Q&A, selective summary:

Aphexda seasonal outlook? Results were really for the spring. We don't see a seasonal slowing for the summer. Multiple myeloma transplants do not seem to be very seasonal in nature.

Getting institutions on formulary is the crucial step. Then looking at selling to them.

Gene therapy studies? Studies have different designs, St. Jude's is not disclosed yet.

Sickle cell has particular problems for mobilization that Aphexda may address. Other gene therapies could benefit from Aphexda as well, but current focus is on sickle cell.

We have requests from investigators to initiate a variety of studies.

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