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 ...

BioLineRx Ltd. (NASDAQ:BLRX) Q3 2022 Earnings Conference Call November 15, 2022 10:00 AM ET Company Participants John Lacey - IR Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Abi Vainstein-Haras - Chief Medical Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2022 Results Confer ...

BioLineRx Ltd. (NASDAQ:BLRX) Q2 2022 Earnings Conference Call August 16, 2022 10:00 AM ET Company Participants Tim McCarthy - IR, LifeSci Advisors Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Abi Vainstein-Haras - 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. Welcome to the BioLineRx Second ...

Exhibit 2 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED) AS OF JUNE 30, 2022 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED) AS OF JUNE 30, 2022 TABLE OF CONTENTS Page Condensed consolidated interim statements of financial position F-1 F-2 F-3 - F-4 F-5 - F-6 F-7 - F-9 | --- | |------------------------------------------------------------------| | | | | | Condensed consolidated interim statements of comprehensive | | Condensed consolidated interi ...

BioLineRx Ltd. (NASDAQ:BLRX) Q1 2022 Earnings Conference Call May 11, 2022 10:00 AM ET Company Participants Tim McCarthy - LifeSci Advisors, IR Philip Serlin - CEO Mali Zeevi - CFO Conference Call Participants Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2022 Conference Call. All participants are presently in a listen-only mode. Following management's formal presentation instructions will be given fo ...

Financial Data and Key Metrics Changes - Research and development expenses for the year ended December 31, 2021, were $19.5 million, an increase of $1.3 million or 7.1% compared to $18.2 million for the year ended December 31, 2020 [29] - The company held $57.1 million of cash, cash equivalents, and short-term bank deposits as of December 31, 2021, indicating a strong financial position to achieve multiple value-creating milestones [30] Business Line Data and Key Metrics Changes - The GENESIS Phase III trial of Motixafortide demonstrated that approximately 90% of patients went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Motixafortide and in only one apheresis session [8] - The pharmacoeconomic studies showed that Motixafortide plus G-CSF was associated with a statistically significant decrease in healthcare resource utilization during the autologous stem cell transplantation process compared to G-CSF alone [11] Market Data and Key Metrics Changes - The U.S. stem cell mobilization market is estimated to be approximately $360 million in 2021, with over 20,000 hematopoietic stem cell transplantations annually, of which approximately 60% are autologous [19][18] - Multiple myeloma represents the largest opportunity within the U.S. stem cell mobilization market, accounting for approximately 58% of all autologous transplants [18] Company Strategy and Development Direction - The company aims to submit an NDA for Motixafortide as a novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022 [31] - There is a focus on maintaining optionality regarding the launch of Motixafortide, either with a partner or independently, to maximize value extraction from the asset [21] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Motixafortide to become the new standard of care for stem cell mobilization in multiple myeloma patients, driven by its differentiated clinical efficacy and safety profile [9] - The company is planning for an aggressive launch of Motixafortide in 2023, which would represent a significant advancement in stem cell mobilization since the approval of plerixafor in 2008 [22] Other Important Information - The company is also advancing its Motixafortide pancreatic cancer program and the intra-tumoral anticancer vaccine AGI-134, with ongoing discussions for potential partnerships [23][25] - An immuno-oncology Scientific Advisory Board has been formed to guide the development of the immuno-oncology pipeline [26] Q&A Session Summary Question: What might be the current rate limiting step for the NDA? - Management indicated that there are no rate limiting issues for the NDA submission, as all necessary data is being prepared [35][36] Question: What elements are being weighed in the decision to commercialize with a partner or build out internally? - The company is evaluating what will bring the most value to shareholders, considering both partnership and internal commercialization options [41] Question: What kind of sales force is needed to address the transplant centers? - Management suggested that a sales force of around 15 to 20 sales representatives would be sufficient to target the top transplant centers [42]

[Corporate Update and Q4 2021 Highlights](index=1&type=section&id=Corporate%20Update%20and%20Q4%202021%20Highlights) This section highlights BioLineRx's significant advancements in Q4 2021 and early 2022, focusing on Motixafortide's market potential, regulatory progress, and key upcoming milestones [Key Achievements and Corporate Developments](index=1&type=section&id=Key%20Achievements%20and%20Corporate%20Developments) During the fourth quarter of 2021 and the subsequent period, BioLineRx made significant progress, particularly with its lead candidate, Motixafortide. The company identified a ~$360 million US market opportunity, successfully completed a pre-NDA meeting with the FDA for stem cell mobilization, and reported positive pharmacoeconomic data showing substantial cost savings. Additionally, recruitment for the Phase 1/2a trial of its second oncology program, AGI-134, was completed - A third-party market assessment identified a commercial opportunity of approximately **$360 million** for Motixafortide in the US stem cell mobilization market[2](index=2&type=chunk)[4](index=4&type=chunk)[7](index=7&type=chunk) - Following a successful pre-New Drug Application (NDA) meeting, the FDA agreed that the existing data package is sufficient to support an NDA submission for Motixafortide in stem cell mobilization, which is anticipated in **mid-2022**[2](index=2&type=chunk)[4](index=4&type=chunk)[9](index=9&type=chunk) - A pharmacoeconomic study demonstrated significant potential cost savings with Motixafortide. Compared to plerixafor + G-CSF, the Motixafortide regimen is associated with a net cost saving of approximately **$30,000 per patient**, excluding the cost of Motixafortide itself[2](index=2&type=chunk)[4](index=4&type=chunk)[5](index=5&type=chunk) - The company completed recruitment for part 2 of the ongoing Phase 1/2a trial of AGI-134, an anti-cancer vaccine program for solid tumors[6](index=6&type=chunk) [Management Commentary](index=2&type=section&id=Management%20Commentary) CEO Philip Serlin expressed strong optimism regarding Motixafortide's potential to become the new standard of care in stem cell mobilization, citing its significant cost benefits and positive Phase 3 results. He highlighted the company's solid financial position, with over $57 million in cash, as sufficient to support the upcoming NDA submission and advance other pipeline programs - The CEO emphasized that the concentrated end market, with approximately **80 US transplant centers** performing the majority of procedures, would require a limited commercialization footprint[7](index=7&type=chunk) - Management believes Motixafortide could be the first true advancement in stem cell mobilization since the approval of plerixafor in 2008, positioning it to become the **new standard of care**[8](index=8&type=chunk) - The company is well-financed with over **$57 million in cash**, which is expected to support the NDA submission for Motixafortide and the advancement of other pipeline programs[9](index=9&type=chunk) [Upcoming Expected Milestones](index=3&type=section&id=Upcoming%20Expected%20Milestones) BioLineRx has outlined a clear timeline of key upcoming milestones. The company plans to submit the NDA for Motixafortide in mid-2022, with potential FDA approval and a US launch projected for 2023. Additionally, initial results for the AGI-134 trial are expected in the second half of 2022 - Key upcoming milestones include: * **Mid-2022:** Submission of NDA to FDA for Motixafortide * **H2 2022:** Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 * **2023:** Initiate Phase 2 study of AGI-134 * **2023:** Potential FDA approval and US launch of Motixafortide[10](index=10&type=chunk) [Financial Results for the Year Ended December 31, 2021](index=3&type=section&id=Financial%20Results%20for%20the%20Year%20Ended%20December%2031%2C%202021) This section details BioLineRx's financial performance for 2021, showing an increased operating loss but a reduced net loss, supported by a strong cash position and significant financing activities [Operating Performance](index=3&type=section&id=Operating%20Performance) For the year ended December 31, 2021, BioLineRx reported an operating loss of $24.8 million, an increase from $22.9 million in 2020. This was driven by higher research and development, sales and marketing, and general and administrative expenses. However, the net loss for the year decreased to $27.1 million from $30.0 million in the prior year, primarily due to lower non-operating and net financial expenses Operating Performance Metrics | Metric | 2021 (in millions USD) | 2020 (in millions USD) | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | 19.5 | 18.2 | +7.1% | | Sales & Marketing Expenses | 1.0 | 0.8 | +19.4% | | General & Administrative Expenses | 4.3 | 3.9 | +10.0% | | Operating Loss | 24.8 | 22.9 | Increased Loss | | Net Loss | 27.1 | 30.0 | Decreased Loss | - The increase in R&D expenses was primarily due to the AGI-134 study and increased payroll expenses, offset by lower costs for the completed Motixafortide trials[11](index=11&type=chunk) [Financial Position and Cash Flow](index=4&type=section&id=Financial%20Position%20and%20Cash%20Flow) The company maintained a strong financial position, ending 2021 with $57.1 million in cash, cash equivalents, and short-term deposits. Net cash used in operating activities remained stable at $23.6 million. A significant inflow of $57.7 million from financing activities, primarily from a public offering and warrant exercises, bolstered the company's cash reserves, despite a net use of cash in investing activities related to short-term bank deposits - As of December 31, 2021, the company held **$57.1 million** in cash, cash equivalents, and short-term bank deposits[17](index=17&type=chunk) Cash Flow Summary | Cash Flow Activity (Year Ended Dec 31) | 2021 (in millions USD) | 2020 (in millions USD) | | :--- | :--- | :--- | | Net cash used in operating activities | (23.6) | (23.2) | | Net cash used in / provided by investing activities | (38.2) | 16.7 | | Net cash provided by financing activities | 57.7 | 17.9 | - The substantial increase in cash from financing activities in 2021 was driven by an underwritten public offering of ADSs in January, warrant exercises, and proceeds from an ATM facility[19](index=19&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) This section presents BioLineRx's consolidated financial statements, highlighting a strengthened balance sheet, reduced comprehensive loss, and significant equity growth driven by financing activities [Consolidated Statements of Financial Position](index=6&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) As of December 31, 2021, BioLineRx's balance sheet showed significant strengthening. Total assets increased to $81.4 million from $47.3 million in 2020, driven by a substantial rise in cash and short-term deposits. Concurrently, total liabilities decreased to $13.3 million from $25.3 million, leading to a robust increase in total equity to $68.1 million Consolidated Balance Sheet Highlights | Balance Sheet Item (in thousands USD) | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | 12,990 | 16,831 | | Short-term bank deposits | 44,145 | 5,756 | | **Total Assets** | **81,391** | **47,290** | | **Total Liabilities** | **13,304** | **25,260** | | **Total Equity** | **68,087** | **22,030** | [Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) For the year ended December 31, 2021, the company reported a comprehensive loss of $27.1 million, a reduction from the $30.0 million loss in 2020. The loss per share improved significantly to $0.04 from $0.12 in the prior year, reflecting a higher weighted average number of shares outstanding Consolidated Comprehensive Loss Summary | Income Statement Item (in thousands USD) | Year 2021 | Year 2020 | | :--- | :--- | :--- | | Research and Development Expenses | (19,466) | (18,173) | | Operating Loss | (24,777) | (22,927) | | Loss and Comprehensive Loss | (27,054) | (30,021) | | Loss Per Ordinary Share (USD) | (0.04) | (0.12) | [Statements of Changes in Equity](index=8&type=section&id=Statements%20of%20Changes%20in%20Equity) Total equity saw a substantial increase during 2021, growing from $22.0 million at the end of 2020 to $68.1 million by year-end 2021. This growth was primarily fueled by the issuance of share capital and warrants, which raised over $50 million, and proceeds from warrant exercises, which brought in an additional $21.2 million, net of the comprehensive loss for the year - Total equity increased from **$22.0 million** at the end of 2020 to **$68.1 million** at the end of 2021[36](index=36&type=chunk) - The primary drivers of the equity increase were the issuance of share capital and warrants (net **$50.4 million**) and the exercise of warrants (**$21.2 million**)[36](index=36&type=chunk) [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2021, net cash used in operating activities was $23.6 million, slightly higher than the $23.2 million used in 2020. Investing activities used $38.2 million, a reversal from the $16.7 million provided in 2020, mainly due to changes in short-term deposits. Financing activities provided a strong inflow of $57.7 million, a significant increase from $17.9 million in 2020, primarily from share and warrant issuances. This resulted in a net decrease in cash and cash equivalents of $4.0 million for the year Consolidated Cash Flow Summary | Cash Flow Summary (in thousands USD) | Year 2021 | Year 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | (23,573) | (23,206) | | Net cash provided by (used in) investing activities | (38,224) | 16,668 | | Net cash provided by financing activities | 57,749 | 17,866 | | **Increase (Decrease) in Cash and Cash Equivalents** | **(4,048)** | **11,328** |