Analyst Conference Summary

biotechnology

conference date: March 26, 2024
for quarter ending: December 31, 2023 (fourth quarter, Q4)

Forward-looking statements

Overview: Continues to make progress with Aphexda.

Basic data (GAAP):

Revenue for full year 2023 was $4.8 million, but all that was in Q4.

Net income for full year 2023 was negative $60.6 million.

Earnings per share, diluted, (EPS) for full year 2023 were negative $0.06

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, including funds available under a debt facility.

Conference Highlights:

Philip Serlin, CEO of BioLineRx, said "Following FDA approval of Aphexda in September, physicians and transplant centers have been very receptive to the value of our strong clinical data, and our commercial team has made substantial progress establishing relationships with transplant centers across the country. This year will continue to be primarily a foundational period for the commercialization of Aphexda. We are seeing substantial progress on Pharmacy & Therapeutics committee approvals, the first step toward center adoption, and are actively supporting centers as they build usage protocols and treat their first patients. Initial feedback on patient experiences has been positive, and we are already seeing repeat purchases. Notably, we have achieved payer coverage representing approximately 95% of covered lives in the U.S. to date, which we believe reflects the value that APHEXDA offers to payers and patients alike," Received a J-code, on formulary status, and positive payer decisions. The $4.8 million Q4 revenue included a $4.6 million upfront payment from Gloria Biosciences. Just $0.2 million was from product sales.

Evaluating Aphexda 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.

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. About 80 transplant centers dominate the apheresis landscape, with about 85% of procedures.

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

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. In February an IND was filed for the bridging study needed for approval, but a few Asian nations do not require the study to proceed and revenue could begin in 2H 2024.

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 and Regeneron with BiolinxRx are expanding into a randomized Phase 2b study, which had its first patient dosed in February 2024. Gloria also partnering in pancreatic cancer.

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 $43 million, up sequentially from $26 million.

Full year 2023 Operating expenses consisted of: Cost of sales $0 million; R&D $12.5 million; sales/marketing $25.3 million; G&A $6.3 million. Impairment $6.7 million. Operating loss $49.7 million. Other expense $10.8 million. Finanical Expense net $0.1 million.

Q&A, selective summary:

Formulary dynamics? Formulary acceptance is critically important. Sales teams work with doctor champions. Can take several months. Some institutions have made the full switch to Aphexda. Still in the uptake ramp.

Clarify: the studies for stem cell mobilization currently do not include gene therapies from either Bluebird or Regeneron.

Chinese pancreatic cancer study? Gloria helps to initiate study late this year or early next year. Patients should recruit quickly. For stem cell mobilization a number of SE Asian nations accept the FDA approval for an early access program. But China, Japan and Korea will require at least 1 bridging study. Pancreatic cancer pathway is longer, will require results from the China trial.

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