Praxis(US:PRAX)2023-02-07 13:11Financial Performance - The company reported net losses of $214.0 million and $167.1 million for the years ended December 31, 2022 and 2021, respectively[437]. - As of December 31, 2022, the company had an accumulated deficit of $530.6 million[438]. - The net loss for the year ended December 31, 2022, was $214.029 million, compared to a net loss of $167.061 million in 2021, reflecting an increase of $46.968 million (28.1%) year-over-year[461]. - Comprehensive loss for 2022 was $214,026,000, compared to a comprehensive loss of $167,237,000 in 2021, indicating an increase of about 28.0%[517]. - The company expects to continue generating operating losses for the foreseeable future, raising substantial doubt about its ability to continue as a going concern[534]. Cash Flow and Liquidity - Cash, cash equivalents, and marketable securities as of December 31, 2022, were $100.5 million, which is expected to fund operations into the first quarter of 2024[441]. - Net cash used in operating activities for 2022 was $185.043 million, compared to $124.554 million in 2021, indicating a significant increase in cash outflow[468]. - Cash and cash equivalents decreased from $138,704,000 in 2021 to $61,615,000 in 2022, a decline of about 55.6%[511]. - The company anticipates continued operating losses and negative cash flows for the foreseeable future, with a need for additional capital to finance operations[477]. Research and Development - Research and development expenses for 2022 totaled $155.0 million, an increase from $120.3 million in 2021[450]. - The company expects substantial increases in expenses related to ongoing research and development activities, particularly for clinical trials and product candidates[475]. - The company plans to advance its lead product candidate, ulixacaltamide, to late-stage clinical trials for essential tremor and Parkinson's disease in 2023[435]. - Accrued research and development expenses totaled $10.7 million as of December 31, 2022, including costs related to the ulixacaltamide Essential1 clinical trial[506]. Operating Expenses - Total operating expenses for the year ended December 31, 2022, were $214.986 million, an increase of $47.654 million (28.5%) compared to $167.332 million in 2021[461]. - General and administrative expenses are anticipated to increase as the company expands its headcount to support growth in research and development activities[456]. - The increase in general and administrative expenses was $12.871 million (27.4%), primarily due to an increase in personnel-related costs[463]. Stock and Financing - The company raised $526.0 million in aggregate cash proceeds from various stock offerings since inception, net of issuance costs[466]. - The company issued and sold 3,595,273 shares under the Sales Agreement in 2022, generating net proceeds of $9.6 million[467]. - The total shares of authorized common stock reserved for future issuance increased from 10,230,564 in 2021 to 12,072,855 in 2022[622]. Assets and Liabilities - Total current assets decreased from $287,409,000 in 2021 to $110,840,000 in 2022, a decline of approximately 61.5%[511]. - Total assets decreased from $292,747,000 in 2021 to $115,128,000 in 2022, representing a reduction of about 60.7%[511]. - Total stockholders' equity decreased from $250,812,000 in 2021 to $76,106,000 in 2022, a decrease of approximately 69.6%[511]. Collaboration and Agreements - A collaboration agreement is expected to result in the recognition of $5.0 million of revenue upon satisfaction of performance obligations[446]. - The Company entered into a Collaboration Agreement with UCB, receiving a $5.0 million upfront payment and potential future payments totaling up to $98.5 million[613]. - Under the license agreement with RogCon, the company may owe a milestone payment of $3.0 million and profit share payments based on a low-double-digit percentage of net profits[484]. Risks and Uncertainties - The company has suffered recurring losses and has limited financial resources, raising substantial doubt about its ability to continue as a going concern[501]. - The company relies on a small number of third-party manufacturers for the supply of materials for its research and development activities, which poses a risk to its operations[549]. - The company is exposed to interest rate fluctuations, but a 100 basis point change would not materially impact its financial position due to the short-term nature of its investments[492].