Bicycle Therapeutics(BCYC) - 2024 Q4 - Annual Report

Financial Performance - The company has incurred net losses of $169.0 million, $180.7 million, and $112.7 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $680.8 million as of December 31, 2024[564]. - The net loss for the year ended December 31, 2024, was $169.031 million, a decrease of $11.633 million from a net loss of $180.664 million in 2023[596]. - The company does not expect to generate revenue from product sales for the foreseeable future, relying instead on collaboration revenue[571]. - The company has not generated revenue from product sales since inception and expects to continue incurring significant operating losses[605]. Revenue and Collaboration - The company has received gross proceeds of $1.4 billion from the sale of ordinary shares and $236.6 million from collaboration agreements since its inception in 2009[563]. - Collaboration revenue increased by $8.3 million in the year ended December 31, 2024, compared to 2023, primarily due to increases from collaborations with Novartis ($6.3 million), Genentech ($2.9 million), and Bayer ($2.2 million)[597]. - Collaboration revenue increased by $8.3 million to $35.3 million in 2024, driven by contributions from collaborations with Novartis, Genentech, and Bayer[596]. - The company has not recognized any sales-based royalty revenue from its collaboration agreements to date[643]. Expenses and Operating Costs - Total operating expenses for 2024 were $245.147 million, an increase of $28.225 million compared to $216.922 million in 2023[596]. - Research and development expenses for the year ended December 31, 2024, were $172.966 million, an increase of $16.470 million from $156.496 million in 2023[596]. - General and administrative expenses rose to $72.181 million in 2024, up by $11.755 million from $60.426 million in 2023[596]. - The company anticipates substantial increases in expenses and capital requirements as it continues its development activities and seeks marketing approvals[565]. - General and administrative expenses are anticipated to rise as the company increases headcount to support research and development and potential commercialization efforts[586]. Cash and Financing - As of December 31, 2024, the company had cash and cash equivalents of $879.5 million, which is expected to fund operations for at least 12 months[570]. - Net cash used in operating activities was $164.72 million in 2024, an increase of $104.1 million compared to 2023, largely due to higher cash payments for ongoing development activities[608]. - Net cash provided by financing activities was $519.75 million in 2024, primarily from net proceeds of $544.1 million from a private placement[610]. - The company expects to finance its cash needs through equity offerings, debt financings, collaborations, and other strategic transactions, which may dilute existing shareholders' ownership[622]. Research and Development - The company is evaluating multiple product candidates, including zelenectide pevedotin and BT5528, in ongoing clinical trials[559]. - The company expects research and development expenses to continue increasing due to an expanded portfolio of product candidates and ongoing clinical trials[579]. - Research and development expenses increased by $16.5 million to $172.97 million in 2024, primarily due to a $38.6 million increase in clinical program expenses for zelenectide pevedotin[599]. - The company incurred approximately $156.6 million in direct external expenses for the development of zelenectide pevedotin since its candidate nomination[600]. Obligations and Liabilities - Total contractual obligations as of December 31, 2024, amounted to $11.18 million, with $6.07 million due within one year[615]. - The company has entered into agreements with third parties for future milestone payments totaling $166.2 million, contingent upon achieving specific milestones[618]. - Future debt financing may involve covenants that restrict the company's operations or ability to incur additional debt[622]. Economic and Market Conditions - High inflation rates and increased costs of clinical trial materials and supplies may adversely affect the company's operating results and cash flows[623]. - The company faces challenges in raising capital due to unfavorable global economic and political conditions, which may impact its development programs[621]. - The company is subject to potential downward pressure on share prices due to economic uncertainty and volatility in capital markets[623].