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BioLineRx(BLRX) - 2022 Q3 - Earnings Call Transcript
2022-11-15 20:11
Financial Data and Key Metrics Changes - Research and development expenses for Q3 2022 were $4.4 million, an increase of $0.5 million or 11.3% compared to $4.9 million for Q3 2021 [31] - For the nine months ended September 30, 2022, research and development expenses were $14.2 million, a decrease of $0.1 million or 1% compared to $14.3 million for the same period in 2021 [32] - Cash balance as of September 30, 2022, was $57.3 million, which includes $10 million from the Kreos agreement and $13.5 million in net proceeds from a registered direct offering [33] Business Line Data and Key Metrics Changes - The NDA for motixafortide, now known as APHEXDA, was submitted and accepted by the FDA, with a PDUFA target action date set for September 9, 2023 [6][12] - Approximately 90% of patients in the GENESIS study went directly to transplantation after mobilizing the optimal number of stem cells following one administration of APHEXDA [8] - The combination of APHEXDA and GCSF resulted in a median collection of approximately 11 million stem cells per kilogram, compared to approximately 2 million in the GCSF arm [9] Market Data and Key Metrics Changes - The US stem cell mobilization market was approximately $360 million annually in 2021 and is expected to grow steadily, with a global market exceeding $500 million [13] - The stem cell mobilization market is highly concentrated, with approximately 80 transplant centers performing about 80% of procedures [14] Company Strategy and Development Direction - The company plans to commercialize APHEXDA independently to accelerate its availability to multiple myeloma patients and maximize the asset's value [12] - The company is focusing on advancing motixafortide in pancreatic cancer through a collaboration with GenFleet Therapeutics, which will conduct a Phase 2B clinical study in China [19] - The company aims to expand the indications for motixafortide beyond multiple myeloma, exploring opportunities in sickle cell anemia and pancreatic cancer [67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the rapid market uptake of APHEXDA if approved, due to its benefits to multiple healthcare stakeholders [11] - The company is well-positioned financially to execute a robust launch plan, with a cash balance that supports multiple value-creating milestones into the first half of 2024 [33] - Management anticipates a catalyst-rich 2023, with key milestones including the potential FDA approval of APHEXDA and the initiation of a Phase 2B study in PDAC [35][70] Other Important Information - The company completed two financings, providing access to up to $55 million, including a $40 million non-dilutive debt financing agreement and a $15 million registered direct equity offering [15][17] - The Chief Medical Officer, Abi Vainstein-Haras, will depart the company effective December 31, 2022, but will remain as an advisor through at least the end of 2023 [36] Q&A Session Summary Question: Will the FDA hold an Advisory Committee meeting for the application? - The FDA has stated they are not currently planning to hold an Advisory Committee meeting to discuss the application [38] Question: What are the primary rate limiting steps for the launch of APHEXDA? - Management is not worried about rate limiting steps, citing a manageable launch and strong market research [40][41] Question: What is the current status of the PDAC program and additional tumor indications? - The company is focusing on the collaboration with GenFleet and the ongoing study with Columbia University, with plans to partner out solid tumor indications once data is available [49][50] Question: Will AGI-134 data be announced at a conference or via press release? - A press release with data from the AGI-134 study is planned by the end of the year, with potential conference presentations in the following year [52][58] Question: What is the anticipated size and structure of the salesforce for APHEXDA? - The company is still analyzing the size of the salesforce but plans to have sales professionals in the field ahead of the launch, focusing on top transplant centers [59][60]
BioLineRx(BLRX) - 2022 Q2 - Earnings Call Transcript
2022-08-16 17:00
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 ...
BioLineRx(BLRX) - 2022 Q2 - Quarterly Report
2022-08-15 16:00
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(BLRX) - 2022 Q1 - Earnings Call Transcript
2022-05-11 17:51
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 ...
BioLineRx(BLRX) - 2021 Q4 - Earnings Call Transcript
2022-03-16 18:52
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]
BioLineRx(BLRX) - 2022 Q1 - Quarterly Report
2022-03-15 16:00
[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** |
BioLineRx(BLRX) - 2021 Q4 - Annual Report
2022-03-15 16:00
Exhibit 99.1 INEEX For Immediate Release BioLineRx Reports Fourth Quarter 2021 Financial Results and Provides Corporate Update - Commercial assessment commissioned indicating US stem-cell mobilization opportunity of ~$360m - - Successful pre-NDA meeting with FDA; NDA submission anticipated in mid-2022 - - Announced highly positive results from additional pharmacoeconomic study indirectly comparing Motixafortide plus G-CSF versus plerixafor plus G-CSF - - Cash and cash equivalents at December 31, 2021 of $57 ...
BioLineRx(BLRX) - 2021 Q4 - Annual Report
2022-03-15 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) of the Securities Exchange Act of 19 ...
BioLineRx(BLRX) - 2021 Q3 - Earnings Call Transcript
2021-11-18 19:25
Financial Data and Key Metrics Changes - Research and development expenses for the nine months ended September 30, 2021, were $14.3 million, an increase of $0.8 million or 5.9% compared to $13.5 million for the comparable period in 2020 [34] - The company held $62.2 million in cash, cash equivalents, and short-term bank deposits as of September 30, 2021, indicating strong financial positioning to achieve multiple value-creating milestones [35] Business Line Data and Key Metrics Changes - The GENESIS Phase 3 study reported that 89% of patients receiving Motixafortide in combination with G-CSF mobilized the optimal number of cells after only one administration and one apheresis session, compared to 10% for G-CSF alone [10][12] - The median number of cells collected in one apheresis session was 11 million for the Motixafortide G-CSF arm, significantly higher than the 2 million cells collected with G-CSF alone [11][22] Market Data and Key Metrics Changes - The global estimated market for autologous stem cell transplantation is approximately $500 million, with over 45,000 procedures performed annually in the U.S. and Europe [24] - The first-generation CXCR4 inhibitor, plerixafor, generates annual sales exceeding $250 million, primarily used as a rescue therapy [24] Company Strategy and Development Direction - The company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2022, following a pre-NDA meeting scheduled for mid-December [25][37] - Future plans include evaluating lifecycle management potential in other autologous stem cell mobilization indications and exploring partnerships for commercialization rather than self-commercialization [52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive results from the GENESIS study and the pharmacoeconomic study, viewing them as significant milestones for the company [38][56] - The company anticipates a catalyst-rich 2022, with meaningful clinical benefits for patients and considerable value creation for shareholders [56][57] Other Important Information - The pharmacoeconomic study indicated a net cost savings of approximately $17,000 per patient when using Motixafortide in combination with G-CSF compared to the current standard-of-care [20][21] - The company has a notable presence at the upcoming American Society of Hematology Annual Meeting, with four abstracts accepted for presentation [29][30] Q&A Session Summary Question: Key components for the upcoming pre-NDA meeting with the FDA - Management aims to align with the FDA on the overall content of the NDA submission [40][41] Question: Next steps for AGI-134 and potential randomized studies - Future steps will depend on the data from the current study, with considerations for patient populations and combination therapies [42][44] Question: Update on the timing of the first data for the academic sponsored trial - Recruitment is ongoing for the investigator-initiated trial, but specific timelines cannot be provided [46][47] Question: Delay in AGI-134 data and presentation at conferences - Recruitment delays were primarily due to COVID-19, but completion is expected by the end of the year, with data anticipated in the first half of next year [48][49] Question: Commercialization strategy for Motixafortide - The company is exploring collaboration options for commercialization rather than self-commercialization due to operational and financial risks [52] Question: Applicability of pharmacoeconomic study results in Europe - The cost structure in Europe differs from the U.S., and while the model can be adapted, the company believes similar significant benefits could be observed [54]
BioLineRx(BLRX) - 2021 Q2 - Earnings Call Transcript
2021-08-18 16:10
BioLineRx Ltd. (NASDAQ:BLRX) Q2 2021 Earnings Conference Call August 18, 2021 10:00 AM ET Company Participants Tim McCarthy - LifeSci Advisors, IR Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Abi Vainstein-Haras - Chief Medical Officer Ella Sorani - Chief Development Officer Conference Call Participants Joe Pantginis - HC Wainwright Mark Breidenbach - Oppenheimer Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2021 Results Con ...