BioLineRx(BLRX) - 2022 Q1 - Quarterly Report

Corporate Update and Q4 2021 Highlights 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 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][4][7] - 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][4][9] - 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][4][5] - 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] Management Commentary 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] - 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] - 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] Upcoming Expected Milestones 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] Financial Results for the Year Ended December 31, 2021 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 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] Financial Position and Cash Flow 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] 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] Consolidated Financial Statements 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 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 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 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] - 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] Consolidated Statements of Cash Flows 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 |