Analyst Conference Summary

biotechnology

conference date: March 31, 2025
for quarter ending: December 30, 2024 (fourth quarter, Q4)

Forward-looking statements

Overview: Focus was on licensing and raising cash.

Basic data (GAAP):

Did not give results for Q4, just full year 2024. Revenue $28.9 million. Net income negative 9.2 million. EPS negative $0.01.

Revenue was $ million, down sequentially from $4.9 million, and up from $0 year-earlier.

Net income was negative $ million, down sequentially from negative $5.8 million, but up from negative $ million year-earlier.

Earnings per share, diluted, (EPS) was $0.00, sequentially from negative $0.00, and up from negative $ year-earlier. The number of diluted shares rose to

Note: American Depository Shares traded on NASDAQ 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 through 2H 2026.

Conference Highlights:

Philip Serlin, CEO of BioLineRx, said "It has been just over four months since we implemented a major strategy shift, highlighted by the transformational exclusive licensing agreement that we entered into with Ayrmid Ltd., granting it the rights to commercialize Aphexda (motixafortide) in all non-solid-tumor indications and all territories other than Asia. Since then, we implemented cost efficiencies across the Company, including the shutdown of our U.S. commercial operations, that have resulted in an approximate 70% reduction in our operating expense base, which, together with recent financings, have put us on a firm footing with a cash runway through the second half of 2026." Biolinerx is making meaningful progress on product evaluation for in licensing for oncology and rare diseases. Shut down U.S. commercial operations in favor of Ayrmid. Believes will be able to pay for new drug development with milestones and royalties from Aphexda. Also restructured remaining debt.

In November 2024 agreed to license Aphexda to Ayrmid Gamida Cell for $10 million upfront, possibly $87 million in milestones, and 18% to 23% tiered royalties on sales. Expects op ex to decline by 70% following the sale, including closing U.S. operations. Excludes Asia. Also received $9 million equity investment from Highbridge Capital. Will look at adding early-stage programs in 2025. BiolineRx retains rights for solid tumors. Called Arymid an ideal partner.

Full year 2024 Revenue consisted of $6 million for Aphexda product sales, up sequentially from $na million, and $22.9 million from licensing.

Launch activities for Aphexda for stem cell mobilization in multiple myeloma continue, but now under Ayrmid. Achieved 10% market share in U.S.

Evaluating Aphexda (motixafortide) for supporting (stem cell collection for) sickle cell gene therapies in a Phase 1 trial. Continues Phase 2 programs in pancreatic cancer combined with a PD-1 inhibitor, with positive preliminary biopsy data presente at ASCO in June 2024. Partnered with Regeneron and Columbia. Expect full enrollment in 2027.

Repaid $16.5 million to BlackRock of the $29 million debt, with remainder to be repaid over 3 years at 9.5% interest.

In Q3 agreed with Gloria Biosciences to partner Aphexda in China, beginning with a bridging study. The bridging study needed for the Asian approval, which was expected to begin in 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 (PDAC), in combination with a PD-1 inhbitor. 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. But not fully enrolled until 2027.

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 $19.6 million, down sequentially from $na million. Had about $9 million in long-term debt. Also received $10 million in January 2025.

Full year 2024 operating expenses consisted of: Cost of sales $9.3 million; R&D $9.1 million; sales/marketing $23.6 million; G&A $6.3 million. Impairment $1 million. Operating loss $20.4 million. Other income $20.3 million. Finanical Expense net $9.1 million.

Q&A, selective summary:

Color on acquiring assets? Can't give a timeline. Looking at early stage assets, having a number of meaningful discussions.

Benchmark for cells collected for sickle cell? 20 to 25 million cells per kilogram, much more than needed for multiple myeloma. Current therapies require multiple cycles, we hope to do it in one cycle, or at least less than competitors. Results so far are very encouraging.

Ayrmid progress? Impressed with their team. Transition went smoothly. They have another product already in the field.

Oncology v. rare disease preference? Specific within those two, mostly oncology.

Expenses going forward? The search project is not expensive. We are looking for a minimal upfrong payment for new products. Then maximize spending on development to move the asset forward as quickly as possible.

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