Financial Data and Key Metrics Changes - Total revenues for the year ended December 31, 2023, were $4.8 million compared to no revenues for the year ended December 31, 2022, primarily reflecting a portion of the upfront payment from the Gloria Biosciences license agreement [42] - Research and development expenses for the year ended December 31, 2023, were $12.5 million, down from $17.6 million in 2022, due to lower expenses related to motixafortide and AGI-134 completion [43] - Net loss for the year ended December 31, 2023, was $60.6 million compared to $25 million in 2022, including $17.8 million of non-cash expenses [46] Business Line Data and Key Metrics Changes - Cost of revenues for the year ended December 31, 2023, amounted to $3.7 million, reflecting a $3 million sublicense fee for APHEXDA and amortization of an intangible asset [41] - Sales and marketing expenses for the year ended December 31, 2023, were $25.3 million, significantly up from $6.5 million in 2022, driven by pre-commercialization and commercialization activities related to motixafortide [44] Market Data and Key Metrics Changes - The company has established access for 95% of covered lives across a mix of both commercial and government payers for APHEXDA [24] - The company estimates that Asia had over 51,000 reported cases of multiple myeloma, representing a significant opportunity for stem cell mobilization [16] Company Strategy and Development Direction - The company aims to continue the commercialization of APHEXDA, with expectations to secure formulary placement in top transplant centers managing approximately 60% of all procedures by year-end [11][22] - The company is also focusing on expanding its presence in Asia through collaborations, including a bridging study for APHEXDA in China [14][15] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the early momentum of APHEXDA's launch, noting positive feedback from transplant centers and payers [12][26] - The company anticipates significant opportunities in pancreatic cancer and sickle cell disease, with ongoing clinical trials expected to yield data in the second half of the year [38][50] Other Important Information - The company had cash, cash equivalents, and short-term bank deposits of $43 million as of December 31, 2023, which is expected to fund operations into 2025 [47] - The company is in discussions with multiple stakeholders regarding the potential use of motixafortide in gene therapy processes [58] Q&A Session Summary Question: Understanding the formulary process for APHEXDA - Management explained that formulary acceptance is critical and involves a process that can take several months, requiring education and protocol development at transplant centers [54][56] Question: Gene therapy opportunities and collaborations - Management confirmed ongoing discussions with companies and institutions regarding the use of motixafortide in gene therapy, particularly for those requiring CD34+ stem cells [58][59]

FDA Approval and Product Development - APHEXDA (motixafortide) received FDA approval on September 8, 2023, for use in combination with filgrastim for stem cell mobilization in multiple myeloma patients[15] - The company is focused on advancing motixafortide for various conditions, including sickle cell disease and pancreatic cancer, alongside its legacy product BL-5010 for skin lesions[15] - The company entered into a License Agreement in August 2023, granting HST an exclusive license for motixafortide in Asia, with a $15 million upfront payment received in October 2023[58] - The company is entitled to up to $49 million based on development and regulatory milestones in China and Japan, and up to $197 million in sales milestones for motixafortide[122] - The company will receive tiered royalties ranging from 10% to 20% on net sales of motixafortide, payable on a country-by-country basis for up to fifteen years[122] Financial Performance and Revenue - Revenues for the year ended December 31, 2023, were $4.8 million, with $4.6 million recognized from a License Agreement and $0.2 million from product sales of APHEXDA in the U.S.[82] - Cost of revenues for the year ended December 31, 2023, was $3.7 million, reflecting Biokine's share of the up-front payment for the License Agreement and net sales[83] - BioLineRx Ltd. reported a comprehensive loss for the year ended December 31, 2023, amounting to $199 million, compared to $152 million in 2022, reflecting a 31% increase in losses[172] - The company’s total assets as of December 31, 2023, were $250 million, up from $200 million in 2022, indicating a 25% growth in asset base[101] - The company’s total equity as of December 31, 2023, was $100 million, reflecting a decrease from $120 million in 2022, indicating a 17% decline in shareholder equity[101] Expenses and Cost Management - The cost of revenues will mainly consist of manufacturing costs for APHEXDA and royalties payable to licensors from direct product sales[17] - The company anticipates significant research and development expenses for ongoing preclinical and clinical development projects, with costs being inherently unpredictable[19] - Research and development expenses for the year ended December 31, 2023 were $12.5 million, a decrease of $5.1 million, or 29.0% compared to $17.6 million for the year ended December 31, 2022[53] - Sales and marketing expenses for the year ended December 31, 2023 were $25.3 million, an increase of $18.8 million, or 291.1% compared to $6.5 million for the year ended December 31, 2022[55] - General and administrative expenses for the year ended December 31, 2023 were $6.3 million, an increase of $1.2 million, or 24.6% compared to $5.1 million for the year ended December 31, 2022[55] Cash Flow and Funding - As of December 31, 2023, the company held $43.0 million in cash, cash equivalents, and short-term bank deposits[58] - Net cash used in operating activities decreased to $22.6 million in 2023 from $26.2 million in 2022, a reduction of $3.6 million[60] - Net cash provided by financing activities was $15.1 million for the year ended December 31, 2023, compared to $20.4 million in 2022[60] - The company incurred accumulated losses of $391 million through December 31, 2023, and expects to continue incurring losses until products reach commercial profitability[60] - The company expects existing cash and investment balances to meet capital requirements into 2025, while seeking additional funding sources[60] Corporate Governance and Compliance - The audit committee is composed of independent directors, ensuring compliance with SEC and Nasdaq rules, and is responsible for overseeing the company's accounting and financial reporting[28] - The board of directors determined that at least one director with financial and accounting expertise is required, and Rami Dar has been identified as such[40] - The company opted out from the Companies Law requirement to appoint external directors effective March 25, 2024[50] - The current Compensation Policy was approved at the annual general meeting of shareholders held in 2022, focusing on performance-based compensation linked to long-term stakeholder value creation[52] - Management concluded that internal control over financial reporting was effective as of December 31, 2023[143] Legal and Regulatory Matters - The company is involved in ongoing legal proceedings, with a potential claim of approximately NIS 113.5 million (approximately $32 million) related to alleged misleading statements[87] - The company is subject to the information and periodic reporting requirements of the Exchange Act, filing periodic reports with the SEC[136] - The independent registered public accounting firm, Kesselman & Kesselman, issued an attestation report on the effectiveness of internal control over financial reporting[144] Shareholder and Tax Information - The company has no current plans to pay dividends, and any future dividends would be paid in NIS[101] - U.S. Investors may credit Israeli taxes paid on distributions against their U.S. federal income tax liability[101] - The company has not determined if it will be classified as a Passive Foreign Investment Company (PFIC) for the taxable year ending December 31, 2024[101] - A U.S. Investor generally recognizes capital gain or loss upon the sale of ordinary shares or ADSs, with long-term capital gains applicable if held for more than one year[102] - Non-Israeli shareholders face a 25% withholding tax on dividends, which may increase to 30% for substantial shareholders[98]

"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 no ...

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Financial Data and Key Metrics Changes - The company reported a net loss of $16 million for the three months ended September 30, 2023, compared to a net loss of $6.8 million for the same period last year, primarily due to significant non-operating expenses related to the revaluation of outstanding warrants and increased sales and marketing expenses [101] - Research and development expenses decreased by 37.6% to $2.7 million compared to $4.3 million for the corresponding period last year [61] - The company held $26 million in cash, cash equivalents, and short-term bank deposits as of September 30, 2023, which does not include approximately $30 million from a license agreement and equity investment [62] Business Line Data and Key Metrics Changes - Sales and marketing expenses for the three months ended September 30, 2023, were $8.1 million, an increase of 517.4% compared to $1.3 million for the same period last year, driven by significant launch-related activities for Motixafortide in the U.S. [85] - The approval of APHEXDA is seen as a significant advancement in stem cell mobilization, with the potential to improve outcomes for multiple myeloma patients [42][65] Market Data and Key Metrics Changes - The company estimates that approximately 8,000 autologous stem cell transplant procedures are performed annually in the U.S., a figure that has nearly doubled since 2010 [71] - The addition of Motixafortide to G-CSF allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the control group [76] Company Strategy and Development Direction - The company is focusing on the commercialization of APHEXDA in the U.S. and exploring partnerships in significant markets for stem cell mobilization [30][54] - The company is also pursuing opportunities for Motixafortide in pancreatic cancer and sickle cell disease, indicating a strategic expansion into solid tumors and genetic diseases [78][83] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term opportunity for APHEXDA, citing positive feedback from transplant centers regarding its efficacy and efficiency [43][76] - The company is confident in its ability to meet operational needs and fund activities into 2025, supported by recent financing and partnerships [62][28] Other Important Information - The company has established unrestricted access to over 90% of covered lives, representing a mix of both commercial and government payers [77] - The company is evaluating additional commercialization partnership opportunities in significant markets for APHEXDA [55] Q&A Session Summary Question: How quickly is the addition of APHEXDA to the NCCN guidelines incorporated into practice? - Management indicated that changes from NCCN guidelines are typically incorporated into practice immediately, influencing payer decisions on reimbursement [20] Question: What are the key areas of focus for the company during the launch of APHEXDA? - Management highlighted the importance of efficiency, efficacy, and patient experience as key pillars of their value proposition, with a particular emphasis on efficiency resonating well with decision-makers [92][109] Question: Can you provide guidance on cash and share balance at the end of the year? - Management confirmed that the company has over $50 million in cash on a pro forma basis, which is sufficient to support operations into 2025 [28]

Financial Data and Key Metrics Changes - Research and development expenses for Q2 2023 were $3 million, a decrease of $2.4 million or 44.3% compared to $5.4 million in Q2 2022, primarily due to lower NDA supporting activities for Motixafortide and completed AGI-134 clinical trial expenses [25] - Net loss for Q2 2023 was $18.5 million, compared to $7.4 million in Q2 2022, with a six-month net loss of $30.7 million compared to $12.4 million in the same period last year [26] - The company held $32.8 million in cash, cash equivalents, and short-term bank deposits as of June 30, 2023, excluding approximately $30 million from a strategic partnership and $30 million available under a debt agreement [27] Business Line Data and Key Metrics Changes - The lead program, Motixafortide, is preparing for a PDUFA target action date of September 9, 2023, which could transition the company to a commercial stage [7] - The U.S. market potential for mobilization agents in stem cell transplants is estimated at around $300 million, with about 50% from autologous stem cell transplants in multiple myeloma [10] - A new strategic partnership in Asia includes a $15 million upfront payment and potential milestone payments totaling approximately $250 million [11][12] Market Data and Key Metrics Changes - The company is focusing on the U.S. market for the launch of Motixafortide, with strong relationships being built with payers and healthcare providers [9][38] - In Asia, the partnership will require some countries to conduct bridging studies for approval, while others may rely on FDA approval [41][42] Company Strategy and Development Direction - The company aims to capture a significant share of the multiple myeloma transplant market and is well-positioned for the commercial launch of Motixafortide [10] - There are plans for a randomized Phase 2/3 clinical trial in China for Motixafortide in combination with a PD-1 inhibitor for metastatic pancreatic cancer [15] - The company is exploring additional therapeutic areas for Metixafortide, including gene therapy for sickle cell disease [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA approval and the readiness for a quick market entry if approved [38] - The company is optimistic about the potential of Motixafortide to address unmet needs in multiple myeloma and pancreatic cancer [19] - The strategic partnership is expected to strengthen the company's balance sheet and provide sufficient capital for operations beyond the launch [53] Other Important Information - The company announced a collaboration with Washington University School of Medicine to evaluate Metixafortide for gene therapies in sickle cell disease [20] - The company is preparing for significant advancements in its pancreatic development program and further positioning Motixafortide for development in Asia [59] Q&A Session Summary Question: Can you share details about the launch logistics for the upcoming PDUFA date? - Management confirmed readiness for a quick market entry if approved, with supply and distribution agreements already in place [38] Question: What are the timelines for tech transfer in the Asian partnership? - Management indicated that some countries may rely on FDA approval, while others, like China and Japan, may require bridging studies [41][42] Question: How does the Asian partnership impact the company's financial strategy? - The partnership significantly strengthens the balance sheet, providing over $60 million in cash, which is expected to support operations well into 2024 [53] Question: What is the expected cash burn rate going forward? - The current burn rate is estimated between $7.5 million to $10 million per quarter, expected to stabilize around $7 million to $8 million post-launch [54]

BioLineRx Ltd. (NASDAQ:BLRX) Q1 2023 Earnings Conference Call May 24, 2023 10:00 AM ET Company Participants John Lacey - Investor Relations Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Ella Sorani - Chief Development Officer Tami Rachmilewitz - Chief Medical Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. ...

BioLineRx Ltd. (NASDAQ:BLRX) Q4 2022 Earnings Conference Call March 22, 2023 10:00 AM ET Company Participants John Lacey - Investor Relations Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Ella Sorani - Chief Development Officer Conference Call Participants Mark Breidenbach - Oppenheimer Joe Pantginis - Wainwright John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx 2022 Financial Resul ...

Drug Development and Clinical Trials - The company has two clinical-stage therapeutic candidates in its drug development pipeline, focusing on advancing them toward commercialization [257]. - Motixafortide has shown a 4.9-fold increase in the proportion of patients mobilizing ≥ 6 million CD34+ cells/kg after one administration, compared to the control arm [272]. - The Phase 3 trial for motixafortide demonstrated a treatment effect of 54.6% (95% CI 39.7-69.5%; p<0.0001) in mobilizing stem cells, with an odds-ratio of 12.9 [272]. - The median number of CD34+ cells collected on the first day of apheresis was approximately 11 million in the treatment arm, over five times higher than the control arm [272]. - The FDA accepted the NDA submission for motixafortide in November 2022, with a PDUFA target action date set for September 9, 2023 [272]. - The company entered a clinical collaboration in March 2023 to test motixafortide in combination with natalizumab for Sickle Cell Disease [273]. - AGI-134, acquired in March 2017, is in development for solid tumors and utilizes the body's anti-alpha-gal antibodies for a systemic anti-tumor response [278]. - The company plans to continue follow-up on GENESIS study patients for relapse-free and overall survival outcomes [272]. - The composite complete remission rate for motixafortide treatment was 38% in subjects receiving up to two cycles at doses of 1 mg/kg and higher, compared to a historical response rate of approximately 19% for high-risk AML patients treated with Ara-C alone [291]. - In the expansion phase of the motixafortide study, the response rate was 39% with a median overall survival of 10.7 months, significantly higher than the historical data of 6.1 months for HiDAC alone [291]. - The Phase 1b study for AGI-134 met its primary endpoint of safety and tolerability, with next steps to be determined in the first half of 2023 [363]. - The company plans to initiate a Phase 2b randomized clinical trial for motixafortide in first-line metastatic PDAC patients in 2023 [363]. - The Phase 3 registration study for motixafortide showed highly statistically significant results (p<0.0001) across all primary and secondary endpoints, demonstrating its safety and tolerability [363]. Financial Performance and Funding - The company did not generate significant revenues during the years included in the financial statements, with only immaterial amounts received from an outlicensing agreement signed in 2014 with Perrigo Company plc included in non-operating income [329]. - As of December 31, 2022, the company has not yet capitalized development expenses, indicating ongoing investment in research and development without immediate financial returns [326]. - The company held $51.1 million in cash, cash equivalents, and short-term bank deposits as of December 31, 2022, to fund operations [381]. - Future revenues are anticipated to primarily come from the independent commercialization of motixafortide, if approved, and from potential out-licensing agreements [382]. - The company expects to continue incurring substantial operating losses over the next several years as it expands its research and development activities [381]. - The company recognized net non-operating income of $5.7 million for the year ended December 31, 2022, compared to net non-operating expenses of $1.8 million for the year ended December 31, 2021 [416]. - The company entered into a loan agreement with Kreos Capital for up to $40 million in three tranches, with the initial tranche of $10 million drawn down in September 2022 [395]. - The company expects to require additional financing in the future to fund operations, despite current resources being sufficient into the first half of 2024 [396]. - The company incurred accumulated losses of $330 million through December 31, 2022 [395]. Regulatory and Compliance - The company is subject to various regulations governing clinical trials and commercial sales in multiple countries, which may affect the approval process and timelines [351]. - The company must comply with EU pharmacovigilance regulations, which have increased the financial and organizational burden on market authorization holders [345]. - The company is prohibited from manufacturing products developed with IIA grants outside of Israel without special approval, which could lead to increased royalty payments [353]. - The company’s marketing authorization holders must collect data on adverse events associated with the use of authorized products outside the scope of the authorization [345]. Corporate Governance and Compensation - The Board of Directors consists of seven members, including two external directors as required by the Companies Law [431]. - The Audit Committee is comprised of three directors, including all external directors, with Mr. Rami Dar serving as Chairperson [438]. - The company is required to have at least one director with financial and accounting expertise, currently held by Mr. Rami Dar and Dr. Michael J. Anghel [432]. - The Audit Committee oversees the independent registered public accounting firm and recommends engagement or termination of the auditor [439]. - The Compensation Committee must consist of at least three members, including all external directors, with a majority being external directors [441]. - The current Compensation Policy was approved by shareholders in 2022, establishing a framework for office holders' terms of employment and performance-based compensation [451]. - The company provides two types of variable compensation: short-term annual bonuses and long-term stock option plans [451]. - The Compensation Policy aims to discourage short-term risk-oriented behavior and promote long-term sustainability and value creation [451]. - The company analyzes overall market compensation trends to inform its compensation approach [451]. - The fixed component of compensation reflects the specific role, responsibilities, experience, and skills required for each position [451]. - The Board of Directors has the authority to approve changes in the incentive structure for executive officers, subject to formal approval by relevant parties [451]. Asset Management and Financial Risk - The company’s financial assets at amortized cost are included in other receivables and bank deposits in the consolidated statements of financial position, reflecting a conservative approach to asset management [311]. - Borrowings are initially recognized at fair value and subsequently measured at amortized cost, with adjustments recognized in profit or loss as financial income or expense [302]. - The company has no material credit losses reported in 2021 and 2022, indicating effective credit risk management [313]. - The company recognizes a loss allowance for expected credit losses on financial assets at amortized cost, reflecting a proactive approach to financial risk management [313]. - The company performs annual impairment reviews for its non-financial assets, ensuring that asset values are accurately reflected in the financial statements [310]. - Trade payables are classified as current liabilities if payment is due within one year, demonstrating the company's commitment to managing short-term obligations [318]. - Deferred tax assets are not recognized in the financial statements as the company is primarily engaged in development and regulatory activities [319].

ERX BioLineRx Reports 2022 Financial Results and Recent Corporate and Portfolio Updates - Entered into Clinical Trial Collaboration with Washington University School of Medicine to Evaluate Motixafortide for Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease - • Appointed Tami Rachmilewitz, M.D. as Chief Medical Officer • Finalized formation of the U.S. commercial leadership team, which collectively has significant drug launch and sales experience, with particular expertise in st ...