By John Vandermosten, CFA
NASDAQ:BLRX
READ THE FULL BLRX RESEARCH REPORT
BioLineRx Ltd. (NASDAQ:BLRX) reported full-year 2024 results, with revenues reaching $28.9 million. As the company completes its commercialization transition of Aphexda (motixafortide) to Gamida Cell, its focus is shifting to replenishing its pipeline with a new development asset. Management reiterated their objective of acquiring early-stage assets in oncology and rare diseases. The team is conducting due diligence with several parties and remains on track to make a decision in 2025. However, no material details on progress were disclosed.
2024 Operational and Financial Results
BioLineRx reported 2024 sales of $28.9 million producing a net loss of ($9.2) million or ($0.01) per share. Ignoring non-operating income, net loss was ($20.4) million. The results were announced in a press release on March 31st, 2025 followed by a conference call with management and the filing of Form 20-F providing additional information.
Below we summarize financial results for the twelve-month period ended December 31st, 2024, compared to the same prior year period:
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Revenues were $28.9 million representing a portion of the upfront and milestone payment from Gloria Biosciences of about $13 million and an upfront payment from Ayrmid of approximately $10 million versus $4.6 million in the prior year. Aphexda product revenues totaled $6.0 million versus $190,000 in 2023;
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Cost of revenues was $9.3 million which largely represents a pass through to license-holder Biokine as a royalty on motixafortide revenues. Amortization of intangible assets is also included in cost of revenues. Product gross margin relating to Aphexda sales was 94.8%;
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Research and development expenses totaled $9.1 million, down 27% from $12.5 million, on account of lower expenses related to payroll, services professional fees and share-based compensation partially offset by higher lab costs;
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Sales and marketing expenses were $23.6 million, down 7% from $25.3 million due to lower medical affairs, marketing, office and market access expenses partially offset by higher payroll and related, travel and business analytics costs;
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General and administrative (G&A) expenses were $6.3 million, essentially flat with prior year levels with declines in payroll, professional fees, insurance and share based compensation offset by recognition of a provision for doubtful accounts which did not appear in the prior period;
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Non-operating expense was $18.4 million reflecting changes in fair-value adjustments of warrant liabilities on the balance sheet;
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Net financial expenses amounted to ($7.2) million reflecting interest expense exceeding interest income;
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Net loss was ($9.2) million compared with ($60.6) million, or ($0.01) and ($0.06) per share respectively.
Cash, equivalents and short-term bank deposits as of December 31st, 2024 totaled $19.6 million, down from the year end 2023 balance of $43.0 million. Cash burn for 2024 was ($43.9) million and net cash from financing was $20.7 million. Financing cash contributions came from issuance of share capital and warrants as well as net proceeds from the loan agreement with BlackRock. During the fourth quarter, BioLineRx received a $9 million equity investment and used these proceeds along with the $10 million milestone from Ayrmid to reduce the BlackRock debt by $16.5 million. At year end, debt was carried at $9.0 million on the balance sheet. Following the end of the reporting period, BioLineRx conducted a registered direct offering, raising $10 million gross.
ADS Ratio Change
In mid-January, BioLineRx announced a change in the ratio of American Depositary Shares (ADS) to ordinary shares. Prior to the announcement, each ADS represented 15 underlying shares; after January 30, 2025, each ADS represents 600 underlying shares. Total ADSs outstanding following the change will be 3,558,503. The ADS will continue to trade on the Nasdaq Capital Market while the underlying shares will continue to trade on the Tel Aviv Stock Exchange.
Registered Direct Offering
On January 6th, 2025, BioLineRx announced a $10 million registered direct offering. Adjusted for the subsequent ADS ratio change, 1.25 million new ADS were issued at $8.00 per ADS. Each ADS has a warrant attached with an $8.00 exercise price and a five-year life. H.C. Wainwright is the exclusive placement agent. Proceeds from the raise will be used for research and development activities, the expansion of the pipeline of potential drug candidates, and working capital and general corporate purposes. Net proceeds were $8.9 million after deducting fees and expenses.
Background on Commercialization Agreement with Ayrmid Pharma
On November 21st, BioLineRx announced an exclusive license agreement with Ayrmid Pharma Ltd., the parent company of Gamida Cell, where Ayrmid will assume commercialization rights for Aphexda in stem cell mobilization. The deal provides a $10 million upfront payment, commercial milestones for sales and additional regulatory approvals totaling $87 million and royalties ranging from 18% to 23%. Ayrmid gains rights in all geographies excluding Asia[1] in all indications except for solid tumor indications.[2] Along with the Ayrmid agreement, BioLineRx raised an additional $9 million equity investment with Highbridge Capital that will be used to reduce debt.[3]
Ayrmid’s subsidiary, Gamida Cell, will execute the commercialization effort. Gamida Cell is now marketing Omisirge, a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. The product is indicated for use in patients with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. BioLineRx is taking advantage of the substantial overlap between the target market for Aphexda and Omisirge. BioLineRx will separate its US commercialization subsidiary and transfer a part of the team to Gamida Cell to continue its activities. The transition of the Aphexda commercialization activities from BioLineRx to Gamida Cell is expected to be complete in early 2025.
We see the integration into the Gamida Cell sales team as a beneficial change as the group will now have more products to offer as well as a broader reach, thereby increasing the efficiency of the marketing effort. There is merit in layering on a new product to an existing sales team which has developed relationships and established territories. Additionally, the incremental cost of adding one new product to the mix is minimal. BioLineRx has noted that while it has cost about $25 million to sustain the sales team to support Aphexda inside of BioLineRx, there is only a $3 to $5 million incremental cost anticipated to market Aphexda using the Gamida Cell sales force.
Shareholder Letter
In January, chief executive Phil Serlin reiterated the details of the arrangement with Ayrmid and Gloria Biosciences in a letter to shareholders, noting where each is advancing the interests of motixafortide. Ayrmid has the right to develop and commercialize Aphexda in all indications, excluding solid tumor indications and in all territories outside of Asia. Gloria holds the rights to develop and commercialize motixafortide in Asia in all indications. Gloria will first commercialize and gain additional approvals for Aphexda in the region and also conduct clinical trials in pancreatic ductal adenocarcinoma. Both Ayrmid and Gloria have paid and will pay upfronts, milestones and royalties on sales.
With the transfer of commercialization activities to Gamida Cell in its final stages and Gloria advancing motixafortide interests in Asia, BioLineRx is looking forward to its next iteration as a research and development company. With an FDA-approved asset under its belt, management offers its expertise in development to advance another asset to approval. The company is seeking to buy a preclinical and a clinical asset with the funds received from its partnerships and apply its development expertise to obtain a new approved product. BioLineRx is considering oncology or rare disease candidates and reports that it is actively working on this and is reviewing many promising opportunities.
With the capital raised from the recent deals and the equity financing combined with a substantially reduced cost structure, BioLine anticipates having sufficient cash to support activities until 2H:26. This forecast does not include any contributions from sales royalties or commercial milestones.
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[1] Rights to motixafortide have already been granted to Gloria Biosciences in Asia.
[2] BioLineRx will retain rights to solid tumor indications for motixafortide.
[3] Highbridge Capital is also an investor in Gamida Cell.
