BioLineRx(US:BLRX)2022-03-15 16:00Market Opportunity - The US stem cell mobilization market presents a commercial opportunity of approximately $360 million[4] Regulatory Progress - The company successfully completed a pre-NDA meeting with the FDA, with NDA submission anticipated in mid-2022[4] - Upcoming milestones include NDA submission for Motixafortide in mid-2022 and potential FDA approval in 2023[10] Financial Performance - Cash and cash equivalents as of December 31, 2021, were $57.1 million, providing a solid financial foundation for future activities[6] - The company's operating loss for the year ended December 31, 2021, was $24.8 million, compared to a loss of $22.9 million in 2020[13] - The company reported a comprehensive loss of $27,054 thousand for the year ended December 31, 2021, compared to a loss of $30,021 thousand in 2020, indicating an improvement of 10%[33] Research and Development - Research and development expenses for the year ended December 31, 2021, were $19.5 million, a 7.1% increase from $18.2 million in 2020[11] - Research and development expenses for the year ended December 31, 2021, were $19,466 thousand, compared to $18,173 thousand in 2020, reflecting a 7% increase[33] Cash Flow and Financing - Net cash used in operating activities for the year ended December 31, 2021, was $23.6 million, slightly up from $23.2 million in 2020[17] - Net cash provided by financing activities for the year ended December 31, 2021, was $57.7 million, compared to $17.9 million in 2020, reflecting a successful public offering[19] - Cash and cash equivalents at the end of the year decreased from $16,831 thousand in December 2020 to $12,990 thousand in December 31, 2021, a decline of 23%[39] Asset and Liability Management - Total assets increased from $47,290 thousand in December 2020 to $81,391 thousand by December 31, 2021, representing a growth of 72%[30] - Current assets rose significantly from $22,880 thousand to $57,404 thousand, an increase of 151%[30] - Total liabilities increased from $25,260 thousand in December 2020 to $13,304 thousand in December 31, 2021, indicating a substantial rise in financial obligations[30] - The total equity increased from $22,030 thousand in December 2020 to $68,087 thousand by December 31, 2021, a growth of 209%[30] Expense Management - Sales and marketing expenses increased by 19.4% to $1.0 million for the year ended December 31, 2021, compared to $0.8 million in 2020[12] - Depreciation and amortization expenses decreased from $940,000 in 2019 to $703,000 in Q1 2021, reflecting a decline of approximately 25%[41] - Share-based compensation expenses were $1,759,000 in 2019, decreasing to $1,495,000 in Q1 2021, a reduction of about 15%[41] Interest and Other Financial Metrics - Interest on loans decreased from $647,000 in 2019 to $301,000 in Q1 2021, a reduction of about 53%[41] - Interest received in cash decreased from $868,000 in 2019 to $138,000 in Q1 2021, a decline of approximately 84%[41] Non-Cash Transactions - Non-cash transactions increased significantly from $147,000 in 2019 to $10,112,000 in Q1 2021, highlighting a major change in transaction structure[41] Changes in Financial Position - Fair value adjustments of warrants showed a significant change from $(4,634,000) in 2019 to $1,936,000 in Q1 2021, indicating a positive shift in valuation[41] - The total cash used in operating activities was $1,544,000 in 2019, improving to $4,021,000 in Q1 2021, indicating better cash flow management[41] - The decrease in prepaid expenses and other receivables was $1,106,000 in 2019, dropping to $24,000 in Q1 2021, showing a substantial decline[41] - Accounts payable and accruals saw a decrease of $3,218,000 in 2019, while in Q1 2021, it was $(564,000), indicating a shift in liability management[41] - Exchange differences on cash and cash equivalents showed a negative trend, worsening from $(108,000) in 2019 to $(207,000) in Q1 2021[41]