Bicycle Therapeutics(BCYC) - 2022 Q4 - Annual Report

Financial Performance - The company has incurred net losses of $112.7 million, $66.8 million, and $51.0 million for the years ended December 31, 2022, 2021, and 2020, respectively, with an accumulated deficit of $331.1 million as of December 31, 2022[618]. - The net loss for 2022 was $112.7 million, compared to a net loss of $66.8 million in 2021, indicating a worsening financial position[644]. - The company incurred significant operating losses and negative cash flows since inception in 2009, with no revenue generated from product sales[652]. - Net cash used in operating activities for 2022 was $86.1 million, a significant increase from $14.8 million in 2021, attributed to a higher net loss and changes in operating assets and liabilities[653]. - Net cash provided by financing activities was $6.7 million in 2022, a sharp decline from $320.7 million in 2021, primarily due to reduced proceeds from share offerings[657]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future, relying primarily on collaboration revenues[623]. - Revenue is primarily generated through collaborative arrangements and license agreements, with various payment structures including upfront fees and milestone payments[675]. - The company has not recognized any sales-based royalty revenue from collaboration agreements to date[689]. Collaboration and Partnerships - The company has received $135.2 million in cash payments under collaboration revenue arrangements, including $46.6 million from Ionis and $54.0 million from Genentech[617]. - Collaboration revenues increased by $2.8 million in 2022, primarily due to a $5.1 million increase from the collaboration with Ionis, offset by a $2.1 million decrease from Genentech[647]. - Future milestone payments related to agreements with Cancer Research UK and Pepscan Systems B.V. could total $203.6 million, contingent upon achieving specific development and regulatory milestones[664]. Expenses and Costs - Research and development expenses rose to $81.6 million in 2022, up from $44.9 million in 2021, reflecting the higher costs associated with later-stage clinical trials[644]. - General and administrative expenses increased to $49.5 million in 2022, compared to $32.4 million in 2021, driven by higher personnel costs and public company expenses[644]. - Total operating expenses for 2022 were $131.1 million, a significant increase from $77.3 million in 2021[644]. - The company expects research and development expenses to continue increasing due to an expanded portfolio of product candidates and ongoing clinical trials[628]. - The company expects general and administrative expenses to continue increasing as it expands headcount to support research and development and potential commercialization efforts[635]. Cash and Liquidity - The company had cash and cash equivalents of $339.2 million as of December 31, 2022, which is expected to fund operations for at least 12 months[622]. - As of December 31, 2022, the company had cash and cash equivalents of $339.2 million, expected to fund operating expenses for at least 12 months[665]. - The company anticipates future capital requirements will depend on factors such as drug discovery costs, clinical trial enrollment, and regulatory review outcomes[667]. Economic and Market Conditions - The ongoing COVID-19 pandemic and geopolitical tensions have led to significant disruptions in global financial markets, contributing to a general economic slowdown and high inflation rates[670]. - Rising inflation and interest rates may adversely affect operating results, particularly in clinical trial materials and labor costs, potentially stressing working capital resources[672]. - Economic conditions, including high inflation and geopolitical tensions, may adversely affect the company's financial position and cash flows[672]. Product Development - The company is developing multiple product candidates, including BT5528, BT8009, BT1718, BT7480, and BT7455, with ongoing clinical trials[611]. - The FDA granted Fast Track Designation to BT8009 for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer[615]. - The company plans to continue developing product candidates, including BT5528, BT8009, BT7480, and BT1718, and to seek marketing approvals for successful candidates[659]. - The company anticipates significant commercialization expenses if any product candidates receive marketing approval, impacting future cash flows[660]. Financial Obligations - The company has outstanding term loans of $30.0 million under a Loan Agreement with Hercules, with additional loans of up to $45.0 million available until December 31, 2024[658]. - Total contractual obligations as of December 31, 2022, amounted to $54.1 million, including $16.0 million in operating lease commitments and $38.0 million in debt obligations[661].