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DBV Technologies(DBVT) - 2021 Q3 - Quarterly Report

Financial Performance - Operating income for Q3 2021 was $1.3 million, a decrease of 68% from $4.2 million in Q3 2020[67]. - Net loss for Q3 2021 was $24.0 million, a 22% improvement from a net loss of $31.0 million in Q3 2020[66]. - Operating income for the nine months ended September 30, 2021, was $2.776 million, a decrease of $9.713 million (78%) compared to $12.488 million in the same period in 2020[76]. - Net loss was $84.1 million for the nine months ended September 30, 2021, an improvement from a net loss of $120.1 million for the same period in 2020, resulting in a net loss per share of $1.53[86]. - Financial income was $0.3 million for the three months ended September 30, 2021, compared to a financial expense of $1.2 million in the same period in 2020, indicating a positive shift in financial performance[72]. - Financial income was $0.6 million for the nine months ended September 30, 2021, compared to a financial expense of $1.4 million for the same period in 2020[84]. - The company recorded an income tax profit of $0.4 million for the nine months ended September 30, 2021, primarily due to US tax refunds[85]. Expenses - Research and development expenses decreased by 37% to $16.3 million in Q3 2021 from $25.8 million in Q3 2020[66]. - Total operating expenses decreased by 24% to $25.7 million in Q3 2021 compared to $33.9 million in Q3 2020[66]. - Sales and marketing expenses amounted to $1.1 million for the three months ended September 30, 2021, a decrease of $524,000 (33%) compared to $1.6 million in the same period in 2020, mainly due to reduced employee-related costs[69]. - General and administrative expenses increased by $1.4 million (21%) for the three months ended September 30, 2021, compared to the same period in 2020, driven by higher external professional services and employee-related costs[70]. - Total research and development expenses for the nine months ended September 30, 2021, were $58.7 million, a decrease of $16.6 million (22%) compared to $75.2 million in the same period in 2020[78]. - Sales and marketing expenses for the nine months ended September 30, 2021, were $2.999 million, down $5.1 million (63%) from $8.114 million in the same period in 2020, primarily due to workforce reductions[81]. - Employee-related costs in research and development decreased by $8.3 million (44%) for the nine months ended September 30, 2021, compared to the same period in 2020, due to workforce reductions[79]. - External clinical-related expenses decreased by $3.2 million (9%) for the nine months ended September 30, 2021, compared to the same period in 2020, as a result of cost containment measures[78]. - General and administrative expenses decreased by $0.6 million, or 2%, to $26.25 million for the nine months ended September 30, 2021, compared to $26.84 million for the same period in 2020[82]. Cash Flow and Liquidity - Net cash flow used in operating activities decreased by $42.6 million, or 32%, to $89.5 million for the nine months ended September 30, 2021, compared to $132.1 million for the same period in 2020[89]. - Cash and cash equivalents decreased to $98.2 million as of September 30, 2021, down from $221.4 million on September 30, 2020[92]. - The company expects its current cash and cash equivalents will support operations into the third quarter of 2022, but there is substantial doubt regarding the ability to continue as a going concern[94]. - The company did not incur any restructuring costs for the nine months ended September 30, 2021, following a global restructuring plan initiated in June 2020[83]. - The company has not incurred any bank debt and has not entered into any off-balance sheet arrangements[93][98]. Research and Development - The company completed the CHAMP trial in Q2 2021, demonstrating improved adhesion performance of modified Viaskin Peanut patches compared to the current patch[62]. - The FDA has requested a 6-month well-controlled adhesion trial for the modified Viaskin Peanut patch, which will not be initiated until feedback is received[62]. - The company is preparing responses to the EMA's Day 180 letter regarding the Viaskin Peanut MAA, with a potential decision expected in Q1 2022[63]. - The company generated $1.6 million from the French research tax credit in Q3 2021, a decrease of 9% from $1.8 million in Q3 2020[67]. - The company has selected two modified patches for further development based on their performance in the CHAMP trial[62]. - The company is advancing its Viaskin technology to treat food allergies, focusing on safety for infants and children[62]. - Research and development expenses decreased by $9.4 million (37%) for the three months ended September 30, 2021, compared to the same period in 2020, primarily due to a decrease in depreciation, amortization, and employee-related costs[68].