Financial Performance - The company reported a net loss of $29.1 million for the three months ended March 31, 2025, with an accumulated deficit of $4.5 billion[148]. - Total revenue for the three months ended March 31, 2025, was $38.7 million, an increase of $20.1 million compared to $18.6 million for the same period in 2024, primarily due to eight additional infusions[177]. - The net loss for the three months ended March 31, 2025, was $29.1 million, a decrease of $40.7 million compared to a net loss of $69.8 million in the same period of 2024[177]. - Net cash used in operating activities for the three months ended March 31, 2025, was $43.4 million, a decrease from $74.7 million in the same period of 2024[189]. Cash and Liquidity - Cash and cash equivalents were approximately $78.7 million as of March 31, 2025, with restricted cash of $13.6 million[150][154]. - As of March 31, 2025, the company had cash and cash equivalents of approximately $78.7 million, primarily held in U.S. government agency securities and money market accounts[182]. - The company expects existing cash and cash equivalents to fund operations into June 2025, contingent on the completion of the Merger Transaction[185]. - The company cautions that its cash runway estimate may be affected by revenues and operating costs that could differ materially from current assumptions[154]. Research and Development - The company plans to continue incurring research and development expenses while scaling manufacturing capabilities for its gene therapies[152][165]. - Research and development expenses were $17.7 million for the three months ended March 31, 2025, down from $25.1 million in 2024, reflecting a decrease of $7.4 million[180]. - The accumulated deficit as of March 31, 2025, was $4.5 billion, with expectations for research and development expenses to decrease as commercial activities increase[183]. Mergers and Acquisitions - A merger agreement was announced on February 21, 2025, with a cash tender offer of $3.00 per share plus a contingent value right or $5.00 per share[149][157]. - The merger transaction is expected to close in the first half of 2025, which is critical for the company's liquidity[149][151]. - The company entered into a Merger Agreement on February 21, 2025, with expectations for completion in the first half of 2025[184]. Sales and Financing Activities - The company sold its first Rare Pediatric Disease Priority Review Voucher for net proceeds of $102.0 million and the second for $92.9 million in early 2023[145]. - In Q1 2023, the company sold its second PRV for aggregate net proceeds of $92.9 million[193]. - In Q1 2023, the company sold 1.2 million shares of common stock at $120.00 per share, generating aggregate net proceeds of $130.5 million[193]. - In December 2023, the company sold 4.2 million shares of common stock at $30.00 per share, resulting in aggregate net proceeds of $118.1 million[193]. - The company entered into a Loan Agreement for up to $175.0 million in debt financing in March 2024[193]. - The company has not made any sales pursuant to the Open Market Sales Agreement with Jefferies LLC as of March 31, 2025, which allows for sales up to $125.0 million[193]. Cost Management - Cost of product revenue decreased to $12.2 million for the three months ended March 31, 2025, from $25.9 million in the same period of 2024, attributed to reduced costs related to excess manufacturing capacity[178]. - Selling, general and administrative expenses decreased to $30.3 million for the three months ended March 31, 2025, from $46.3 million in 2024, a reduction of $16.1 million[179]. - The company has never been profitable and expects to continue incurring significant expenses and operating losses for the foreseeable future[148]. Regulatory Approvals - The FDA approved three gene therapies: ZYNTEGLO, SKYSONA, and LYFGENIA, with commercialization efforts focused in the U.S.[140][141]. Market Risks - The company has exposure to market risk related to changes in interest rates, primarily due to investments in short-term securities[194].
bluebird bio(BLUE) - 2025 Q1 - Quarterly Report