BioLineRx Reports 2023 Financial Results and Recent Corporate and Portfolio Updates
- None.
- Net loss for the year ended December 31, 2023, was $60.6 million, a significant increase from $25.0 million in 2022.
- Non-operating expenses for the year ended December 31, 2023, were $10.8 million, compared to non-operating income of $5.7 million in 2022.
- Sales and marketing expenses for the year ended December 31, 2023, were $25.3 million, a substantial increase from $6.5 million in 2022.
Insights
The announcement of APHEXDA's payer coverage reaching approximately 95% of covered lives in the U.S. represents a significant milestone for BioLineRx. This level of coverage is indicative of the drug's perceived value by payers, which is often a function of its clinical efficacy, cost-effectiveness and the unmet need it addresses. The widespread coverage suggests a strong market acceptance and potential for substantial revenue growth. The inclusion of APHEXDA in the NCCN guidelines further solidifies its position in the treatment landscape, potentially increasing its adoption in clinical practice.
In the context of the stock market, such developments can positively influence investor sentiment as they reflect both the commercial viability of the product and the effective execution of the company's market penetration strategy. The impact on the stock price could be significant, especially if the adoption rate meets or exceeds current projections. However, investors will need to monitor the actual sales figures and market share captured over time to gauge the long-term financial implications.
Reviewing the financial results, BioLineRx's reported revenue of $4.8 million for the year ended December 31, 2023, marks its transition from a development-stage company to generating commercial revenue. This is a key inflection point for any biopharmaceutical company. The cost of revenues, at $3.7 million, indicates a high gross margin, which is typical for pharmaceutical products but will need to be balanced against ongoing and future R&D and sales and marketing expenses.
Investors should note the substantial increase in sales and marketing expenses to $25.3 million, reflecting the costs associated with commercializing APHEXDA. This uptick is expected as the company builds its market presence, but it will be important to track how these expenses trend in relation to revenue growth. The net loss of $60.6 million, including significant non-cash expenses, may raise concerns about the company's burn rate and the need for additional capital. However, the current cash reserves appear sufficient to fund operations into 2025, which may mitigate immediate dilution concerns for existing shareholders.
The progression of motixafortide in clinical trials, particularly in the context of pancreatic cancer, is a critical factor for BioLineRx's future prospects. Pancreatic cancer has a high unmet medical need and new therapies that demonstrate efficacy can rapidly gain market share. The collaboration with Columbia University and the initiation of the randomized Phase 2b trial are steps towards validating the drug's efficacy in combination with PD-1 inhibitors, a growing class of immunotherapies.
Investors with a focus on clinical development will be interested in the upcoming data from the proof-of-concept Phase 1 study in sickle cell disease gene therapy. Positive results could open up a new therapeutic area for motixafortide. However, the inherent risks of clinical trials, including potential safety issues and lack of efficacy, should be considered. The long-term success of motixafortide will depend on the outcomes of these trials and the ability of the company to navigate the regulatory landscape in different regions, including China.
- Reported significant commercial progress for APHEXDA® -- secured payer coverage representing ~
- Announced first patient dosed in randomized Phase 2b clinical trial evaluating motixafortide in first-line pancreatic cancer -
- Continued to support partner Gloria Biosciences in plans to execute pivotal bridging study of motixafortide in stem cell mobilization and Phase 2b randomized study in first-line pancreatic cancer in
- Management to host conference call today, March 26, at 8:30 am EDT -
"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," said Philip Serlin, Chief Executive Officer of BioLineRx. "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
"Additionally, through a clinical collaboration with
"At the same time, we are making significant progress advancing clinical programs evaluating motixafortide in pancreatic cancer, which if ultimately approved in combination with PD-1 inhibitors, would serve a much larger patient population and provide confidence for expanding into additional solid tumors. In pancreatic cancer, our enthusiasm is bolstered by the compelling data presented last fall from the single-arm pilot phase of the Phase 2b trial sponsored by Columbia University. The first patient has now been dosed in the randomized Phase 2b portion of that study, and we are also working with Gloria Biosciences on the design and execution of a similar randomized Phase 2b combination trial of motixafortide and zimberelimab in pancreatic cancer in
"Our vision of bringing a best-in-class stem cell mobilization agent to market, as well as advancing development in pancreatic cancer and other solid tumor areas with major unmet needs, is being actively realized. We look forward to the exciting, continued execution progress that our commercial and development teams will make this year," Mr. Serlin concluded.
Corporate Updates
- Launched APHEXDA (motixafortide) in the
U.S. - Announced closing of exclusive license agreement that includes development and commercialization rights to motixafortide across all indications in the
Asia region, as well as a strategic equity investment - 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 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
- Reported positive coverage decisions by payers representing ~
95% of all covered lives in the U.S. - Received inclusion of APHEXDA in the National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Cell Transplantation
- Achieved "on formulary" status for APHEXDA within targeted top 80 transplantation centers (which perform
85% of allU.S. transplants) managing ~20% of stem cell transplant procedures at these institutions; anticipate similar on formulary status of ~35% at end of Q2 2024 and ~60% at year-end 2024 - Received Healthcare Common Procedure Coding System (HCPCS) J-Code to facilitate Medicare reimbursement for APHEXDA to transplant centers treating Medicare beneficiaries
Clinical Portfolio Updates
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
- Presented posters at both the American Society of Hematology (ASH) 65th Annual Meeting on December 10, 2023, and the 2024 Tandem Meetings on February 21-24, 2024. The posters reviewed combination premedication benefits in the Phase 3 GENESIS trial, extended PD effect of elevated CD34+ cells in peripheral blood, and a post-hoc subgroup analysis of impaired HSC mobilization patients that demonstrated a consistent benefit of motixafortide + G-CSF over placebo + G-CSF mobilization for all patients
- Supported collaboration partner Gloria Biosciences with stem cell mobilization bridging study IND filing in February with the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate regulatory action in May 2024 and initiation of pivotal clinical trial in 2H 2024
Pancreatic Ductal Adenocarcinoma (mPDAC)
- Announced first patient dosed in a randomized, investigator-initiated Phase 2b clinical trial in collaboration with Columbia University assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in 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 data in 2H 2024
Financial Results for Year Ended December 31, 2023
- Total revenues for the year ended December 31, 2023, were
$4.8 million $4.6 million $0.2 million U.S. - Cost of revenues for the year ended December 31, 2023, amounted to
$3.7 million $3.0 million Asia , as well as amortization of an intangible asset in respect of these license revenues in the amount of$0.5 million 6% of related sales. - Research and development expenses for the year ended December 31, 2023, were
$12.5 million $17.6 million - Sales and marketing expenses for the year ended December 31, 2023, were
$25.3 million $6.5 million - General and administrative expenses for the year ended December 31, 2023, were
$6.3 million $5.1 million - Non-operating expenses for the year ended December 31, 2023, were
$10.8 million $5.7 million - Net loss for the year ended December 31, 2023 was
$60.6 million $25.0 million $17.8 million $11.1 million $6.7 million $6.4 million - As of December 31, 2023, the Company had cash, cash equivalents, and short-term bank deposits of
$43.0 million
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2023 has been filed with the
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. | ||
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||
December 31, | ||
2022 | 2023 | |
in USD thousands | ||
Assets | ||
CURRENT ASSETS | ||
Cash and cash equivalents | 10,587 | 4,255 |
Short-term bank deposits | 40,495 | 38,739 |
Trade receivables | - | 358 |
Prepaid expenses | 198 | 1,048 |
Other receivables | 721 | 830 |
Inventory | - | 1,953 |
Total current assets | 52,001 | 47,183 |
NON-CURRENT ASSETS | ||
Property and equipment, net | 726 | 473 |
Right-of-use assets, net | 1,772 | 1,415 |
Intangible assets, net | 21,885 | 14,854 |
Total non-current assets | 24,383 | 16,742 |
Total assets | 76,384 | 63,925 |
Liabilities and equity | ||
CURRENT LIABILITIES | ||
Current maturities of long-term loans | 1,542 | 3,145 |
Contract liabilities | - | 12,957 |
Accounts payable and accruals: | ||
Trade | 6,966 | 10,869 |
Other | 1,744 | 3,353 |
Current maturities of lease liabilities | 427 | 528 |
Total current liabilities | 10,679 | 30,852 |
NON-CURRENT LIABILITIES | ||
Warrants | 4,509 | 11,932 |
Long-term loans, net of current maturities | 8,626 | 6,628 |
Lease liabilities | 1,729 | 1,290 |
Total non-current liabilities | 14,864 | 19,850 |
COMMITMENTS AND CONTINGENT LIABILITIES | ||
Total liabilities | 25,543 | 50,702 |
EQUITY | ||
Ordinary shares | 27,100 | 31,355 |
Share premium | 338,976 | 355,482 |
Warrants | 1,408 | 1,408 |
Capital reserve | 14,765 | 17,000 |
Other comprehensive loss | (1,416) | (1,416) |
Accumulated deficit | (329,992) | (390,606) |
Total equity | 50,841 | 13,223 |
Total liabilities and equity | 76,384 | 63,925 |
BioLineRx Ltd. | |||||
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||||
Year ended December 31, | |||||
2021 | 2022 | 2023 | |||
in USD thousands | |||||
REVENUES | - | - | 4,800 | ||
COST OF REVENUES | - | - | (3,692) | ||
GROSS PROFIT | - | - | 1,108 | ||
RESEARCH AND DEVELOPMENT EXPENSES | (19,466) | (17,629) | (12,519) | ||
SALES AND MARKETING EXPENSES | (1,003) | (6,462) | (25,270) | ||
GENERAL AND ADMINISTRATIVE EXPENSES | (4,308) | (5,066) | (6,310) | ||
IMPAIRMENT OF INTANGIBLE ASSETS | - | - | (6,703) | ||
OPERATING LOSS | (24,777) | (29,157) | (49,694) | ||
NON-OPERATING INCOME (EXPENSES), NET | (1,830) | 5,670 | (10,819) | ||
FINANCIAL INCOME | 559 | 694 | 2,068 | ||
FINANCIAL EXPENSES | (1,006) | (2,158) | (2,169) | ||
LOSS AND COMPREHENSIVE LOSS | (27,054) | (24,951) | (60,614) | ||
in USD | |||||
LOSS PER ORDINARY SHARE – BASIC AND DILUTED | (0.04) | (0.03) | (0.06) | ||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN | 662,933,695 | 773,956,973 | 963,365,525 | ||
BioLineRx Ltd. | |||||||
STATEMENTS OF CHANGES IN EQUITY | |||||||
Ordinary shares |
Share premium |
Warrants |
Capital reserve | Other comprehensive |
Accumulated deficit |
Total | |
in USD thousands | |||||||
BALANCE AT JANUARY 1, 2021 | 9,870 | 279,241 | - | 12,322 | (1,416) | (277,987) | 22,030 |
CHANGES IN 2021: | |||||||
Issuance of share capital and warrants, net | 8,956 | 40,476 | 975 | - | - | - | 50,407 |
Warrants exercised | 2,235 | 18,967 | - | - | - | - | 21,202 |
Employee stock options exercised | 5 | 41 | - | (39) | - | - | 7 |
Employee stock options expired | - | 621 | - | (621) | - | - | - |
Share-based compensation | - | - | - | 1,495 | - | - | 1,495 |
Comprehensive loss for the year | - | - | - | - | (27,054) | (27,054) | |
BALANCE AT DECEMBER 31, 2021 | 21,066 | 339,346 | 975 | 13,157 | (1,416) | (305,041) | 68,087 |
CHANGES IN 2022: | |||||||
Issuance of share capital and warrants, net | 6,029 | (1,007) | 433 | - | - | - | 5,455 |
Employee stock options exercised | 5 | 14 | - | (14) | - | - | 5 |
Employee stock options expired | - | 623 | - | (623) | - | - | - |
Share-based compensation | - | - | - | 2,245 | - | - | 2,245 |
Comprehensive loss for the year | - | - | - | - | (24,951) | (24,951) | |
BALANCE AT DECEMBER 31, 2022 | 27,100 | 338,976 | 1,408 | 14,765 | (1,416) | (329,992) | 50,841 |
CHANGES IN 2023: | |||||||
Issuance of share capital, net | 3,242 | 10,847 | - | - | - | - | 14,089 |
Warrants exercised | 1,000 | 5,559 | - | - | - | - | 6,559 |
Employee stock options exercised | 13 | 45 | - | (31) | - | - | 27 |
Employee stock options expired | - | 55 | - | (55) | - | - | - |
Share-based compensation | - | - | - | 2,321 | - | - | 2,321 |
Comprehensive loss for the year | - | - | - | - | - | (60,614) | (60,614) |
BALANCE AT DECEMBER 31, 2023 | 31,355 | 355,482 | 1,408 | 17,000 | (1,416) | (390,606) | 13,223 |
BioLineRx Ltd. | |||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||
Year ended December 31, | |||
2021 | 2022 | 2023 | |
in USD thousands | |||
CASH FLOWS - OPERATING ACTIVITIES | |||
Loss | (27,054) | (24,951) | (60,614) |
Adjustments required to reflect net cash used in operating | 3,481 | (1,289) | 38,006 |
Net cash used in operating activities | (23,573) | (26,240) | (22,608) |
CASH FLOWS - INVESTING ACTIVITIES | |||
Investments in short-term deposits | (78,000) | (44,000) | (47,588) |
Maturities of short-term deposits | 39,873 | 48,322 | 49,329 |
Purchase of property and equipment | (97) | (131) | (116) |
Purchase of intangible assets | - | (185) | (181) |
Net cash provided by (used in) investing activities | (38,224) | 4,006 | 1,444 |
CASH FLOWS - FINANCING ACTIVITIES | |||
Issuance of share capital and warrants, net of issuance costs | 50,407 | 14,359 | 14,089 |
Exercise of warrants | 10,907 | - | 2,928 |
Employee stock options exercised | 7 | 5 | 27 |
Proceeds from long-term loan, net of issuance costs | - | 9,126 | - |
Repayments of loans | (3,376) | (2,832) | (1,543) |
Repayments of lease liabilities | (196) | (220) | (445) |
Net cash provided by financing activities | 57,749 | 20,438 | 15,056 |
DECREASE IN CASH AND CASH EQUIVALENTS | (4,048) | (1,796) | (6,108) |
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR | 16,831 | 12,990 | 10,587 |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | 207 | (607) | (224) |
CASH AND CASH EQUIVALENTS - END OF YEAR | 12,990 | 10,587 | 4,255 |
BioLineRx Ltd. | ||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||
Year ended December 31, | ||||
2021 | 2022 | 2023 | ||
in USD thousands | ||||
APPENDIX | ||||
Adjustments required to reflect net cash used in operating activities: | ||||
Income and expenses not involving cash flows: | ||||
Depreciation and amortization | 703 | 654 | 1,384 | |
Exchange differences on cash and cash equivalents | (207) | 607 | 224 | |
Fair value adjustments of warrants | 1,936 | (6,425) | 11,054 | |
Share-based compensation | 1,495 | 2,245 | 2,321 | |
Interest and exchange differences on short-term deposits | (262) | (672) | 15 | |
Interest on loans | 301 | 1,117 | 1,148 | |
Warrant issuance costs | - | 171 | - | |
Exchange differences on lease liabilities | 55 | (224) | (42) | |
Intangible assets impairment | - | - | 6,703 | |
4,021 | (2,527) | 22,807 | ||
Changes in operating asset and liability items: | ||||
Increase in trade receivables | - | - | (358) | |
Increase in inventory | - | - | (1,953) | |
Decrease (increase) in prepaid expenses and other receivables | 24 | (650) | (959) | |
Increase (decrease) in accounts payable and accruals | (564) | 1,888 | 5,512 | |
Increase in contract liabilities | - | - | 12,957 | |
(540) | 1,238 | 15,199 | ||
3,481 | (1,289) | 38,006 | ||
Supplemental information on interest received in cash | 138 | 342 | 2,020 | |
Supplemental information on interest paid in cash | 682 | 593 | 1,111 | |
Supplemental information on non-cash transactions: | ||||
Changes in right-of-use asset and lease liabilities | 183 | 706 | 149 | |
Warrant issuance costs | - | 262 | - | |
Purchase of property and equipment | - | 28 | - | |
Fair value of exercised warrants (portion related to | 10,295 | - | 3,631 | |
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SOURCE BioLineRx Ltd.
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