BioLineRx Reports Second Quarter 2024 Financial Results and Recent Corporate and Portfolio Updates
- Secured APHEXDA(®) formulary placement among top 80 transplant centers representing ~37% of stem cell transplant procedures performed, surpassing stated goal for quarter; on-track to reach goal of ~60% by end of Q4 -
- Doubled the number of centers ordering APHEXDA during the second quarter -
- Entered into clinical trial agreement with St. Jude Children's Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease -
- Management to host conference call today, August 15, at 8:30 am EDT -
TEL AVIV, Israel, Aug. 15, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the second quarter ended June 30, 2024, and provided recent corporate and portfolio updates.
"We continue to demonstrate positive commercial launch momentum with APHEXDA, our best-in-class stem cell mobilization agent," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, among our targeted top 80 transplant centers, we've secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, surpassing our stated goal. Additionally, we doubled the number of transplant centers ordering APHEXDA during the second quarter, which is a strong leading indicator and, we believe, reflects centers' growing recognition of the value that APHEXDA offers relative to other mobilization agents. Our goal is to achieve formulary placement at institutions representing approximately 60% of procedures by the end of year, which will support continued revenue growth and ease burdens on patients, caregivers, and transplant centers.
"Our vision is to maximize the potential of APHEXDA by expanding into key areas with high unmet need. To that end, we announced our second clinical trial collaboration, with St. Jude Children's Research Hospital, evaluating APHEXDA for stem cell mobilization in patients with sickle cell disease (SCD) seeking gene therapy. This new collaboration complements the ongoing SCD stem cell mobilization Phase 1 trial at Washington University in St. Louis (Wash U.). APHEXDA has the potential to support the collection of the immense amount of stem cells needed for these complex gene therapies in a more predictable and condensed timeline for patients. The companies launching these new gene therapies for SCD report continued expansion of authorized treatment centers and increased numbers of patients initiating cell collection. We look forward to seeing early data from the Wash U. Phase 1 trial later this year."
APHEXDA Launch Updates
-- Among top 80 transplant centers, secured formulary placement to date at
institutions representing ~37% of stem cell transplant procedures
performed, exceeding the company's stated goal for the quarter; on track
to achieve ~60% by year-end 2024
-- Saw double the number of centers ordering APHEXDA during the second
quarter as compared to the first quarter, which contributed to
quarter-over-quarter net revenue growth of 100%
Clinical Portfolio Updates
Motixafortide
Multiple Myeloma
-- Presented a poster at the American Society for Apheresis (ASFA) 2024
Annual Meeting on April 17, 2024, demonstrating that transplant centers
(averaging, for example, 20 transplants per month), when switching to
G-CSF plus APHEXDA, could increase capacity by 52.0 patient days per
month versus G-CSF alone, or by 12.3 patient days per month versus G-CSF
in combination with plerixafor
-- Presented a poster at the International Society for Pharmacoeconomics
and Outcomes Research (ISPOR) on April 6, 2024, showing that even with
APHEXDA's higher drug acquisition cost compared to other mobilization
regimens, specifically G-CSF alone or G-CSF plus generic plerixafor, the
combination of G-CSF plus APHEXDA may confer a similar or better overall
financial impact while providing centers and patients with an improved
mobilization experience
-- Collaboration partner Gloria Biosciences' stem cell mobilization
bridging study IND was 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
Sickle Cell Disease (SCD) & Gene Therapy
-- Entered into clinical trial agreement with St. Jude Children's Research
Hospital to evaluate motixafortide for hematopoietic stem cell
mobilization for gene therapies in sickle cell disease. The Phase 1
clinical trial is an open-label, multi-center study evaluating the
safety, tolerability, and feasibility of single-agent motixafortide for
the mobilization and collection of CD34+ HSCs in 12 patients (aged 18
and older) with SCD. Anticipate first patient dosed in September 2024
and initial data in 2025
-- Reported continuing enrollment of patients into a Phase 1 clinical trial
evaluating motixafortide as monotherapy and in combination with
natalizumab for stem cell mobilization for gene therapies in sickle cell
disease. The trial, in collaboration with Washington University School
of Medicine in St. Louis, has been expanded from five to 10 patients.
Anticipate initial data in 2H 2024
Pancreatic Ductal Adenocarcinoma (mPDAC)
-- Presented positive biopsy data from the completed pilot phase of the
ongoing CheMo4METPANC Phase 2b clinical trial collaboration with
Columbia University at the American Society of Clinical Oncology (ASCO)
2024 Annual Meeting held on June 1, 2024 in Chicago, IL. New analyses of
paired pre- and on-treatment biopsy samples demonstrated a statistically
significant increase in CD8+ T-cell density in tumors from all 11
patients treated with the combination therapy approach (P=0.007).
Enrollment in the randomized trial targeting 108 patients continues with
full enrollment anticipated in 2027
-- Completed design of Phase 2b randomized clinical trial in China with
collaboration partner Gloria Biosciences intended to assess
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
Second Quarter 2024 Financial Results
-- Total revenue for the three months ended June 30, 2024 was $5.4 million.
The Company did not record any revenue during the second quarter of
2023. Revenue for the quarter reflects a portion of the upfront payment
from the Gloria Biosciences license, which amounted to $3.6 million, as
well as $1.8 million of net revenue from product sales of APHEXDA in the
U.S.
-- Cost of revenue for the three months ended June 30, 2024 was $0.9
million. The Company did not record any cost of revenue during the
second quarter of 2023. Cost of revenue for the quarter primarily
reflects the amortization of intangible assets, royalties on net product
sales of APHEXDA in the U.S., and cost of goods sold on product sales
-- Research and development expenses for the three months ended June 30,
2024 were $2.2 million, compared to $3.0 million for the same period in
2023. The decrease resulted primarily from lower expenses related to
motixafortide New Drug Application (NDA) supporting activities,
termination of the development of AGI-134 and a decrease in share-based
compensation
-- Sales and marketing expenses for the three months ended June 30, 2024
were $6.4 million, compared to $5.6 million for the same period in 2023.
The increase resulted primarily from the ramp-up in headcount costs
associated with a fully hired field team
-- General and administrative expenses for the three months ended June 30,
2024 were $1.6 million, compared to $1.3 million for the same period in
2023. The increase resulted primarily from an increase in legal and
certain other expenses
-- Net income for the three months ended June 30, 2024 was $0.5 million,
compared to net loss of $18.5 million for the same period in 2023. The
net income for the 2024 period included $7.8 million in non-operating
income, compared to non-operating expenses of $7.7 million for the same
period in 2023, both primarily related to the non-cash revaluation of
warrants
-- As of June 30, 2024, the Company had cash, cash equivalents, and
short-term bank deposits of $40.1 million. The Company anticipates that
this amount will be sufficient to fund operations, as currently planned,
into 2025
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 19, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
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 U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
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 the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic, the Russian invasion of Ukraine, the declared war by Israel against Hamas and the military campaigns against Hamas and other terrorist organizations, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 26, 2024. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
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Contacts:
United States
John Lacey
BioLineRx
IR@biolinerx.com
Israel
Moran Meir
LifeSci Advisors, LLC
moran@lifesciadvisors.com
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
December 31, June 30,
2023 2024
in USD thousands
Assets
CURRENT ASSETS
Cash and cash equivalents 4,255 9,623
Short-term bank deposits 38,739 30,437
Trade receivables 358 3,179
Prepaid expenses 1,048 1,581
Other receivables 830 656
Inventory 1,953 3,634
Total current assets 47,183 49,110
NON-CURRENT ASSETS
Property and equipment, net 473 344
Right-of-use assets, net 1,415 1,452
Intangible assets, net 14,854 13,690
Total non-current assets 16,742 15,486
Total assets 63,925 64,596
Liabilities and equity
CURRENT LIABILITIES
Current maturities of long-term loan 3,145 10,656
Contract liabilities 12,957 5,477
Accounts payable and accruals:
Trade 10,869 6,266
Other 3,353 2,530
Current maturities of lease liabilities 528 500
Warrants 11,932 5,087
Total current liabilities 42,784 30,516
NON-CURRENT LIABILITIES
Long-term loan, net of current maturities 6,628 18,790
Lease liabilities 1,290 1,309
Total non-current liabilities 7,918 20,099
CONTINGENT LIABILITIES
Total liabilities 50,702 50,615
EQUITY
Ordinary shares 31,355 34,411
Share premium 355,482 352,428
Warrants 1,408 1,408
Capital reserve 17,000 17,968
Other comprehensive loss (1,416) (1,416)
Accumulated deficit (390,606) (390,818)
Total equity 13,223 13,981
Total liabilities and equity 63,925 64,596
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
Three months ended Six months ended
June 30, June 30,
2023 2024 2023 2024
in USD thousands in USD thousands
REVENUES - 5,393 12,248
COST OF REVENUES - (897) (2,352)
GROSS PROFIT - 4,496 9,896
RESEARCH AND DEVELOPMENT EXPENSES (3,006) (2,225) (6,690) (4,719)
SALES AND MARKETING EXPENSES (5,604) (6,415) (9,478) (12,757)
GENERAL AND ADMINISTRATIVE EXPENSES (1,305) (1,629) (2,603) (3,015)
OPERATING LOSS (9,915) (5,773) (18,771) (10,595)
NON-OPERATING INCOME (EXPENSES), NET (7,733) 7,807 (10,649) 12,297
FINANCIAL INCOME 440 535 977 1,100
FINANCIAL EXPENSES (1,337) (2,085) (2,264) (3,014)
NET INCOME
(
LOSS) AND COMPREHENSIVE INCOME (LOSS) (18,545) 484 (30,707) (212)
in USD in USD
---
EARNINGS (LOSS) PER SHARE ATTRIBUTABLE TO ORDINARY
SHAREHOLDERS
BASIC (0.02) 0.00 (0.03) (0.00)
DILUTED (0.02) 0.00 (0.03) (0.00)
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF
EARNINGS (
LOSS)
PER SHARE
BASIC 922,958,942 1,197,582,901 922,958,942 1,142,221,033
DILUTED 922,958,942 1,197,582,901 922,958,942 1,142,221,033
BioLineRx Ltd.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
Ordinary Share Warrants Capital Other Accumulated Total
shares premium reserve comprehensive deficit
loss
in USD thousands
BALANCE AT JANUARY 1, 2023 27,100 338,976 1,408 14,765 (1,416) (329,992) 50,841
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2023:
Employee stock options expired - 69 (69)
Share-based compensation - 920 920
Comprehensive loss for the period - (30,707) (30,707)
BALANCE AT JUNE 30, 2023 27,100 339,045 1,408 15,616 (1,416) (360,699) 21,054
Ordinary Share Warrants Capital Other Accumulated Total
shares premium reserve comprehensive deficit
loss
in USD thousands
BALANCE AT JANUARY 1, 2024 31,355 355,482 1,408 17,000 (1,416) (390,606) 13,223
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2024:
Issuance of share capital and warrants, net 3,056 (3,056)
Employee stock options forfeiture (66) (66)
Share-based compensation expenses - 1,036 1,036
Comprehensive loss for the period - (212) (212)
BALANCE AT JUNE 30, 2024 34,411 352,426 1,408 17,970 (1,416) (390,818) 13,981
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Six months ended June
30,
2023 2024
in USD thousands
CASH FLOWS - OPERATING ACTIVITIES
Comprehensive loss for the period (30,707) (212)
Adjustments required to reflect net cash used in operating activities 13,009 (25,226)
(see appendix below)
Net cash used in operating activities (17,698) (25,438)
CASH FLOWS - INVESTING ACTIVITIES
Investments in short-term deposits (6,006) (20,559)
Maturities of short-term deposits 24,000 28,660
Purchase of property and equipment (99) (59)
Purchase of intangible assets (153)
Net cash provided by investing activities 17,742 8,042
CASH FLOWS - FINANCING ACTIVITIES
Issuance of share capital and warrants, net of issuance cost - 5,565
Net proceeds from loan - 19,223
Repayments of loan (1,547)
Repayments of lease liabilities (183) (256)
Net cash provided by (used in) financing activities (183) 22,985
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (139) 5,589
CASH AND CASH EQUIVALENTS - BEGINNING 10,587 4,255
OF PERIOD
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS (344) (221)
CASH AND CASH EQUIVALENTS - END OF PERIOD 10,104 9,623
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Six months ended June
30,
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 457 1,373
Exchange differences on cash and cash equivalents 344 221
Fair value adjustments of warrants 10,843 (12,845)
Share-based compensation 920 970
Interest on short-term deposits (210) 201
Interest on loan 1,405 1,997
Exchange differences on lease liabilities (75) 189
Issuance cost of warrants - 642
13,684 (7,252)
Changes in operating asset and liability items:
Increase in trade receivables - (2,821)
Increase in prepaid expenses and other receivables (958) (359)
Increase in inventory - (1,681)
Increase (decrease) in accounts payable and accruals 283 (5,633)
Decrease in contract liabilities - (7,480)
(675) (17,974)
13,009 (25,226)
Supplemental information on interest received in cash 761 931
Supplemental information on interest paid in cash 640 971
Supplemental information on non-cash transactions:
Changes in right-of-use asset and lease liabilities 66 58
Warrant issuance costs - 207
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