Analyst Conference Summary

biotechnology

conference date: November 25, 2024
for quarter ending: September 30, 2024 (second quarter, Q3)

Forward-looking statements

Overview: After the quarter ended announced licensing out Aphexda, a big change.

Basic data (GAAP):

Revenue was $4.9 million, down sequentially from $5.4 million, and up from $0 year-earlier.

Net income was negative$5.8 million, down sequentially from $0.5 million, but up from negative $16.0 million year-earlier.

Earnings per share, diluted, (EPS) was negative $0.00, flat sequentially from $0.00, and up from negative $0.02 year-earlier. The number of diluted shares rose to nearly 1.2 billion.

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 into 2026.

Conference Highlights:

Philip Serlin, CEO of BioLineRx, said "The license agreement for Aphexda that we announced last week was made possible by the tremendous work of our commercial team, who through their hard work proved the significant value that Aphexda can bring to transplant centers and patients. Our launch progress attracted Ayrmid, who will now, through Gamida Cell, continue to build on the strong commercial foundation that has been laid. We would like to thank our employees for their outstanding contributions to Aphexda growth and expect this innovative product to reach even more patients with the additional resources from Ayrmid. Looking forward, our streamlined and nimble company has a new financial foundation supported by sales royalties and potential milestone payments, which will allow our experienced team to develop important new therapies in rare disease and oncology that address areas with high unmet need. We will also focus on advancing our motixafortide PDAC program through existing collaborations that require de-minimis investment. Through this strategy, we anticipate delivering near- and long-term value for our shareholders." Believes Gamida Cell will substantially increase Aphexda sales.

In November 2024 agreed to license Aphexda to Arymid 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.

Revenue consisted of $1.7 million for Aphexda, down sequentially from $1.8 million, and $3.2 million from Gloria Biosciences (see below).

Launch activities for Aphexda for stem cell mobilization in multiple myeloma continue. In Q3 2024 Aphexda achieved 10 percent market share milestone of total CXCR4 inhibitor usage in the U.S. 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.

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.

Will repay $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. 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 (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. Early Phase 2 data was presented on June 1, 2024 at ASCO. Adding a new arm, 3 new trial sites. But not fully enrolled until 2027.

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 $29.2 million, down sequentially from $40.1 million. Had about $13 million in debt. Following the out-license to Ayrmid, the equity investment from Highbridge and the debt repayment to Blackrock, the cash, cash equivalents and short-term bank deposits are expected to be approximately $20 million.

Operating expenses consisted of: Cost of sales $0.8 million; R&D $2.6 million; sales/marketing $5.6 million; G&A $1.4 million. Operating loss $5.4 million. Other income $0.4 million. Finanical Expense net $1.6 million.

Q&A, selective summary:

Pipeline growth? Plan is for one new asset in 2025, one in 2026, but depends on opportunities.

Other solid tumors? We see PDAC as a prototype for other solid tumors. We are not planning to put more money into solid cancers until we have PDAC results. Gamida has not option on the solid tumor program.

Integration time for Aphexda, sales trend? Hopes for little lag in sales. We are providing transition services. Should be seemless.

Core competencies? Will be returning to our Israeli based roots. Our team has full regulatory, pre-clinical development, etc. We will have cash flows from two partners. PDAC trials have a minimal cost for us. We already have a list of potential candidates to license in rare diseases or cancer.

We will be lean and mean in development, Israeli is a low-cost place to do it.

For a registrational trial for PDAC, it would likely be taken over by a partner. It could be a blockbuster indication, but depends on the data.

First China revenue? Hard to say, hope for first sales in 2025.

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