BioLineRx Reports First Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates
BioLineRx (NASDAQ: BLRX) reported its Q1 2024 financial results and recent corporate updates. The company highlighted steady growth in APHEXDA® adoption, securing formulary placement at institutions representing ~26% of stem cell transplant procedures, targeting 35% by end of Q2. Key developments include new data presented at ASCO 2024 from a Phase 2b pancreatic cancer trial, and the approval of a motixafortide HSC mobilization study in China. Financials showed $6.9 million in total revenue and a net loss of $0.7 million, a significant improvement from a $12.2 million loss in Q1 2023. The company completed $26 million in debt and equity financing to support U.S. commercialization of APHEXDA.
- Steady APHEXDA® adoption, 26% formulary placement in top stem cell transplant institutions.
- On target to reach 35% placement by end of Q2 2024.
- New data from Phase 2b pancreatic cancer trial accepted at ASCO 2024.
- Motixafortide HSC mobilization study approved in China, trial to initiate 2H 2024.
- Completed $26 million in debt and equity financing.
- Total revenue of $6.9 million, compared to $0 in Q1 2023.
- Net loss reduced to $0.7 million from $12.2 million in Q1 2023.
- Cash and equivalents of $28.2 million as of March 31, 2024.
- Anticipates funding operations into 2025.
- Increased sales and marketing expenses to $6.3 million from $3.9 million in Q1 2023.
- R&D expenses decreased to $2.5 million from $3.7 million, potentially indicating reduced activity.
- Cost of revenue for Q1 2024 was $1.5 million, up from $0 in Q1 2023.
- General and administrative expenses rose slightly to $1.4 million from $1.3 million.
- Dependence on new financing and loans to support operations.
Insights
BioLineRx's first quarter 2024 financial results show a substantial improvement compared to the same period in 2023. Revenue reached $6.9 million, driven by milestone payments from Gloria Biosciences and initial sales of APHEXDA®. Notably, the company did not record any revenue in the first quarter of 2023. The cost of revenue at
Operating expenses show a mixed picture: R&D expenses decreased to
The net loss of $0.7 million significantly improved from $12.2 million in the previous year, aided by $4.5 million in non-cash income from warrant revaluation. This reduction in net loss, combined with the company's cash position of $28.2 million (excluding recent financings), provides a healthier outlook. These encouraging results may positively influence investor sentiment and reflect effective financial strategies. However, the increased marketing spend signifies high reliance on APHEXDA’s market uptake, which needs close monitoring for sustainable profitability.
The steady adoption of APHEXDA® post-approval is a positive indicator of market acceptance. Achieving formulary placement at institutions representing approximately
The clinical updates, especially the new data from the Phase 2b pancreatic cancer trial, alongside collaborations and IND approvals in China, reinforce the potential of BioLineRx's pipeline. These activities not only diversify the company's portfolio but also reduce reliance on a single product, contributing positively to long-term growth prospects.
However, the company’s future success hinges on continued positive clinical trial outcomes and achieving further market penetration of APHEXDA®. These factors are important for sustaining revenue growth and achieving profitability. Investors should monitor progress in clinical trials and market adoption closely.
The clinical updates reveal significant progress in BioLineRx's pipeline. The increased CD8+ T-cell density in pancreatic tumors from all treated patients in the pilot phase of the Phase 2 PDAC trial is promising. This finding suggests enhanced immune response and potential efficacy of motixafortide in combination with PD-1 inhibitors, which could address a substantial unmet need in pancreatic cancer treatment.
Further, the upcoming clinical trials and ongoing studies in stem cell mobilization for gene therapies, especially for sickle cell disease, indicate a robust research focus. Successful outcomes here could expand BioLineRx's market and therapeutic applications, driving future growth. Additionally, collaborations with reputable institutions like Washington University add credibility to their research efforts.
The acceptance of abstracts and presentations at major conferences like ASCO underscores the relevance and potential impact of their research. These elements provide compelling reasons for optimism regarding BioLineRx's clinical pipeline, though the inherent risks of clinical trials must be acknowledged.
- Steady growth in APHEXDA® adoption in first full quarter post-approval -
- Among top 80 transplant centers, secured APHEXDA formulary placement to date at institutions representing ~
- Announced new data in abstract accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on pilot phase of ongoing Phase 2b pancreatic cancer clinical trial collaboration with Columbia University -
- Collaboration partner Gloria Biosciences' motixafortide HSC mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in
- Completed debt and equity financing totaling
- Management to host conference call today, May 28, at 8:30 am EDT -
"In this first full quarter post APHEXDA® approval, we were pleased by the steady growth in adoption and repeat purchases by transplant centers, which is consistent with our expectations during this foundational period," said Philip Serlin, Chief Executive Officer of BioLineRx. "This growth comes as we see continued increases in the number of transplant centers that have completed Pharmacy & Therapeutics committee reviews and granted approval for APHEXDA usage. As a reminder, end users of APHEXDA are well defined, with 80 of the 212 U.S. transplant centers performing approximately
"In our major pipeline program in pancreatic cancer, we continue to see strong data emerge from the pilot phase of the Phase 2 PDAC trial sponsored by Columbia University. Last week we announced new data in an accepted ASCO abstract on paired pre- and on-treatment biopsy data that show a significant increase in CD8+ T-cell density in tumors from all 11 patients treated—further reinforcing our belief in the potential of the combination of motixafortide with a PD-1 inhibitor to treat this very challenging cancer with substantial unmet need.
"Finally, we are also making great progress pursuing motixafortide's potential to support gene therapy for patients with sickle cell disease, which requires significant quantities of hematopoietic stem cells. This is an important growth program, and we are actively working with a number of leaders in the gene therapy field, while looking forward to the second half of this year when early data from our collaboration with
Corporate Updates
- Accessed
$20 million $6 million U.S. and to advance lifecycle expansion activities - Strengthened motixafortide intellectual property estate with notice of allowance for
U.S. patent covering method of manufacturing motixafortide suitable for large scale production; the patent supplements existing protections offered by Orphan Drug Designation in theU.S. andEurope for the treatment of pancreatic cancer, as well as Orphan Drug market exclusivity for autologous stem cell mobilization in multiple myeloma patients in theU.S. following last year's FDA approval of APHEXDA
APHEXDA Launch Updates
- Among top 80 transplant centers, secured formulary placement to date at institutions representing ~
26% of stem cell transplant procedures performed – on track to reach stated goal of ~35% by end of Q2 and ~60% by year-end 2024 - Granted "pass through" status from the Centers for Medicare and Medicaid Services (CMS), ensuring that reimbursement for APHEXDA for Medicare and certain commercial payers will be separate from payment bundling methodologies when administered in the hospital outpatient setting
Clinical Portfolio Updates
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
- Presented posters at both the American Society for Apheresis 2024 Annual Meeting on April 17, 2024, and the International Society for Pharmacoeconomics and Outcomes Research on April 6, 2024. The posters reviewed apheresis center efficiency between CXCR4 antagonists, including APHEXDA, in patients with multiple myeloma, as well as economic model data on APHEXDA for HSC mobilization in patients with multiple myeloma
- Collaboration partner Gloria Biosciences' stem cell mobilization bridging study IND filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate initiation of pivotal clinical trial in 2H 2024
Pancreatic Ductal Adenocarcinoma (mPDAC)
- Announced new data in an abstract accepted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on the pilot phase of the ongoing CheMo4METPANC Phase 2 clinical trial collaboration with Columbia University, including new analysis of paired pre- and on-treatment biopsy samples. The presentation will be held on June 1, 2024 in
Chicago, IL - Announced first patient dosed in the randomized CheMo4METPANC Phase 2 clinical trial, an expansion of the pilot phase single-arm study, evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in 108 patients with metastatic pancreatic cancer
- Advanced plans with collaboration partner Gloria Biosciences on a Phase 2b randomized clinical trial in
China assessing motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. Anticipate clinical trial initiation in 2025
Sickle Cell Disease (SCD) & Gene Therapy
- Continued to enroll patients into a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. Anticipate initial data in 2H 2024
First Quarter 2024 Financial Results
- Total revenue for the first three months ended March 31, 2024 was
$6.9 million $5.9 million $0.9 million U.S. - Cost of revenue for the first three months ended March 31, 2024 was
$1.5 million U.S. , as well as amortization of intangible assets and cost of goods sold on product sales - Research and development expenses for the first three months ended March 31, 2024 were
$2.5 million $3.7 million - Sales and marketing expenses for the first three months ended March 31, 2024 were
$6.3 million $3.9 million - General and administrative expenses for the first three months ended March 31, 2024 were
$1.4 million $1.3 million - Non-operating income for the first three months ended March 31, 2024 was
$4.5 million $2.9 million - Net loss for the first three months ended March 31, 2024 was
$0.7 million $12.2 million $4.5 million $2.9 million - As of March 31, 2024, the Company had cash, cash equivalents, and short-term bank deposits of
$28.2 million $6.0 million $20.0
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product is APHEXDA® (motixafortide) with an indication in the
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Forward Looking Statement
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the execution of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide, as well as its potential investigational uses. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether BioLineRx's collaboration partners will be able to execute on collaboration goals in a timely manner; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, operationalize and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in
Contacts:
John Lacey
BioLineRx
IR@biolinerx.com
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
BioLineRx Ltd. | ||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION | ||
(UNAUDITED) | ||
December 31, | March 31, | |
2023 | 2024 | |
in USD thousands | ||
Assets | ||
CURRENT ASSETS | ||
Cash and cash equivalents | 4,255 | 5,990 |
Short-term bank deposits | 38,739 | 22,183 |
Trade receivables | 358 | 2,832 |
Prepaid expenses | 1,048 | 1,290 |
Other receivables | 830 | 507 |
Inventory | 1,953 | 2,889 |
Total current assets | 47,183 | 35,691 |
NON-CURRENT ASSETS | ||
Property and equipment, net | 473 | 411 |
Right-of-use assets, net | 1,415 | 1,308 |
Intangible assets, net | 14,854 | 14,190 |
Total non-current assets | 16,742 | 15,909 |
Total assets | 63,925 | 51,600 |
Liabilities and equity | ||
CURRENT LIABILITIES | ||
Current maturities of long-term loan | 3,145 | 3,680 |
Contract liabilities | 12,957 | 9,027 |
Accounts payable and accruals: | ||
Trade | 10,869 | 8,256 |
Other | 3,353 | 2,455 |
Current maturities of lease liabilities | 528 | 467 |
Warrants | 11,932 | 7,488 |
Total current liabilities | 42,784 | 31,373 |
NON-CURRENT LIABILITIES | ||
Long-term loan, net of current maturities | 6,628 | 5,938 |
Lease liabilities | 1,290 | 1,229 |
Total non-current liabilities | 7,918 | 7,167 |
COMMITMENTS AND CONTINGENT LIABILITIES | ||
Total liabilities | 50,702 | 38,540 |
EQUITY | ||
Ordinary shares | 31,355 | 31,355 |
Share premium | 355,482 | 355,482 |
Warrants | 1,408 | 1,408 |
Capital reserve | 17,000 | 17,533 |
Other comprehensive loss | (1,416) | (1,416) |
Accumulated deficit | (390,606) | (391,302) |
Total equity | 13,223 | 13,060 |
Total liabilities and equity | 63,925 | 51,600 |
BioLineRx Ltd. | ||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS | ||
(UNAUDITED) | ||
Three months ended March 31, | ||
2023 | 2024 | |
in USD thousands | ||
REVENUES | - | 6,855 |
COST OF REVENUES | - | (1,455) |
GROSS PROFIT | - | 5,400 |
RESEARCH AND DEVELOPMENT EXPENSES | (3,684) | (2,494) |
SALES AND MARKETING EXPENSES | (3,874) | (6,342) |
GENERAL AND ADMINISTRATIVE EXPENSES | (1,298) | (1,386) |
OPERATING LOSS | (8,856) | (4,822) |
NON-OPERATING INCOME (EXPENSES), NET | (2,916) | 4,490 |
FINANCIAL INCOME | 537 | 565 |
FINANCIAL EXPENSES | (927) | (929) |
NET LOSS AND COMPREHENSIVE LOSS | (12,162) | (696) |
in USD | ||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED | (0.01) | (0.00) |
WEIGHTED AVERAGE NUMBER OF SHARES USED IN | 922,958,942 | 1,086,589,165 |
BioLineRx Ltd. | |||||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY | |||||||
(UNAUDITED) | |||||||
Ordinary | Share | Warrants | Capital | Other | Accumulated | Total | |
in USD thousands | |||||||
BALANCE AT JANUARY 1, 2023 | 27,100 | 338,976 | 1,408 | 14,765 | (1,416) | (329,992) | 50,841 |
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2023: | |||||||
Employee stock options expired | - | 66 | - | (66) | - | - | - |
Share-based compensation | - | - | - | 435 | - | - | 435 |
Comprehensive loss for the period | - | - | - | - | - | (12,162) | (12,162) |
BALANCE AT MARCH 31, 2023 | 27,100 | 339,042 | 1,408 | 15,134 | (1,416) | (342,154) | 39,114 |
Ordinary |
Share |
Warrants |
Capital | Other |
Accumulated |
Total | |
in USD thousands | |||||||
BALANCE AT JANUARY 1, 2024 | 31,355 | 355,482 | 1,408 | 17,000 | (1,416) | (390,606) | 13,223 |
CHANGES FOR THREE MONTHS ENDED MARCH 31, 2024: | |||||||
Share-based compensation | - | - | - | 533 | - | - | 533 |
Comprehensive loss for the period | - | - | - | - | - | (696) | (696) |
BALANCE AT MARCH 31, 2024 | 31,355 | 355,482 | 1,408 | 17,533 | (1,416) | (391,302) | 13,060 |
BioLineRx Ltd. | ||
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS | ||
(UNAUDITED) | ||
Three months ended March 31, | ||
2023 | 2024 | |
in USD thousands | ||
CASH FLOWS - OPERATING ACTIVITIES | ||
Comprehensive loss for the period | (12,162) | (696) |
Adjustments required to reflect net cash used in operating activities (see appendix below) | 4,146 | (13,413) |
Net cash used in operating activities | (8,016) | (14,109) |
CASH FLOWS - INVESTING ACTIVITIES | ||
Investments in short-term deposits | (5,500) | - |
Maturities of short-term deposits | 12,271 | 16,719 |
Purchase of property and equipment | (32) | (32) |
Purchase of intangible assets | (97) | - |
Net cash provided by investing activities | 6,642 | 16,687 |
CASH FLOWS - FINANCING ACTIVITIES | ||
Repayments of loan | - | (765) |
Repayments of lease liabilities | (49) | (129) |
Net cash used in financing activities | (49) | (894) |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (1,423) | 1,684 |
CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD | 10,587 | 4,255 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (98) | 51 |
CASH AND CASH EQUIVALENTS - END OF PERIOD | 9,066 | 5,990 |
BioLineRx Ltd. | ||
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS | ||
(UNAUDITED) | ||
Three months ended March 31, | ||
2023 | 2024 | |
in USD thousands | ||
Adjustments required to reflect net cash used in operating activities: | ||
Income and expenses not involving cash flows: | ||
Depreciation and amortization | 259 | 897 |
Exchange differences on cash and cash equivalents | 98 | (51) |
Fair value adjustments of warrants | 3,040 | (4,444) |
Share-based compensation | 435 | 533 |
Interest on short-term deposits | (497) | (163) |
Interest on loan | 630 | 610 |
Exchange differences on lease liabilities | (92) | (25) |
3,873 | (2,643) | |
Changes in operating asset and liability items: | ||
Increase in trade receivables | - | (2,474) |
Increase in inventory | - | (936) |
Decrease (increase) in prepaid expenses and other receivables | (121) | 81 |
Increase (decrease) in accounts payable and accruals | 394 | (3,511) |
Decrease in contract liabilities | - | (3,930) |
273 | (10,770) | |
4,146 | (13,413) | |
Supplemental information on interest received in cash | 276 | 357 |
Supplemental information on interest paid in cash | 311 | 255 |
Changes in right-of-use asset and lease liabilities | 66 | 32 |
Logo - https://mma.prnewswire.com/media/2154863/4165445/BioLineRx_Ltd_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-first-quarter-2024-financial-results-and-recent-corporate-and-portfolio-updates-302156149.html
SOURCE BioLineRx Ltd.
FAQ
What were BioLineRx's Q1 2024 financial results?
How has APHEXDA's adoption progressed as of Q1 2024?
What new data was presented at ASCO 2024 by BioLineRx?
What is the status of BioLineRx's motixafortide HSC mobilization study in China?
What financing activities did BioLineRx complete in Q1 2024?
What were the sales and marketing expenses for BioLineRx in Q1 2024?
What were BioLineRx's research and development expenses in Q1 2024?
What is BioLineRx's cash position as of March 31, 2024?
