Dynavax(DVAX) - 2025 Q1 - Quarterly Report

Financial Performance - Total revenues for Q1 2025 were $68.164 million, a 34.2$50.790 million in Q1 2024[18] - Product revenue, net for Q1 2025 was $64.959 million, up 36.0$47.845 million in Q1 2024[18] - The net loss for Q1 2025 was $96.099 million, significantly higher than the net loss of$8.721 million in Q1 2024[18] - Net loss for the three months ended March 31, 2025, was $96,099, compared to a net loss of$8,721 for the same period in 2024[26] - The total stock-based compensation expense for the three months ended March 31, 2025, was $14.5 million, compared to$13.0 million for the same period in 2024[125] Cash and Liquidity - Cash and cash equivalents decreased to $51.720 million as of March 31, 2025, down from$95.883 million at December 31, 2024[16] - Total cash and cash equivalents and marketable securities as of March 31, 2025, amounted to $661.336 million, a decrease from$713.834 million as of December 31, 2024[46] - The total cash and cash equivalents, and restricted cash decreased by $44,153 during the three months ended March 31, 2025[26] - As of March 31, 2025, the company had$661.3 million in cash and cash equivalents, expected to fund operations for at least the next 12 months[178] Operating Expenses - Total operating expenses increased to $91.794 million in Q1 2025, compared to$68.559 million in Q1 2024, representing a 33.9% rise[18] - Research and development expenses rose by $5.8 million (43$13.53 million in Q1 2024 to $19.38 million in Q1 2025, driven by increased spending on the Shingles program and new clinical studies[168] - Selling, general and administrative expenses increased by$3.6 million (8%) from $44.07 million in Q1 2024 to$47.66 million in Q1 2025, mainly due to professional consulting and legal expenses related to an ongoing proxy contest[171] Assets and Liabilities - Total assets as of March 31, 2025 were $945.928 million, a decrease from$986.256 million at December 31, 2024[16] - Total liabilities increased to $414.987 million as of March 31, 2025, compared to$389.457 million at December 31, 2024[16] - The accumulated deficit increased to $999.374 million as of March 31, 2025, compared to$903.275 million at December 31, 2024[16] Inventory and Cost of Sales - Total inventories increased to $74.403 million as of March 31, 2025, compared to$70.054 million as of December 31, 2024[49] - Cost of sales related to yield loss during the production process was approximately $3.4 million for the three months ended March 31, 2025, compared to$1.3 million for the same period in 2024[49] - Cost of sales for HEPLISAV-B increased by $2.8 million (26$10.97 million in Q1 2024 to $13.77 million in Q1 2025, primarily due to increased sales volume and inventory write-offs[165][166] Debt and Financing - Following the Refinancing Transaction, the total principal balance of outstanding convertible notes was$265.2 million as of March 31, 2025[71] - A loss on debt extinguishment of $82.1 million was recognized in the statement of operations for the three months ended March 31, 2025[74] - The total principal balance of outstanding Convertible Notes as of March 31, 2025, was$260.5 million, net of a debt discount of $4.7 million[191] Revenue Recognition and Contracts - The company recognized revenue of$2.8 million from the DoD agreement for the three months ended March 31, 2025[69] - The company received approximately $175.0 million in advance payments under the CEPI Agreement, with$60.3 million remaining as an outstanding balance as of March 31, 2025[138][142] - The contract asset balance associated with Clover was $60.3 million as of March 31, 2025, down from$71.3 million as of December 31, 2024[141] Market and Product Development - The company is advancing a pipeline of differentiated vaccine candidates, including programs for shingles and a plague vaccine funded by the U.S. Department of Defense[29] - HEPLISAV-B is the only two-dose hepatitis B vaccine for adults approved in the U.S., EU, and UK, demonstrating faster and higher rates of protection compared to a three-dose vaccine[135] - The company plans to conduct an observational retrospective cohort study to support the sBLA filing for a HEPLISAV-B vaccine regimen for adults on hemodialysis[151] Tax and Regulatory Matters - The effective tax rate for the three months ended March 31, 2025, was approximately 1.8%, significantly lower than the 24.2% effective tax rate for the same period in 2024[126] - The FDA issued a Complete Response Letter for the supplemental Biologics License Application for HEPLISAV-B for adults on hemodialysis, and the company plans to resubmit in 2025[206] Share Repurchase and Stock Activity - The company had $120.0 million remaining under the at-the-market Sales Agreement with Cowen and Company, LLC as of March 31, 2025[108] - The share repurchase program authorized by the Board of Directors allows for the repurchase of up to$200.0 million worth of common stock, with an accelerated share repurchase agreement executed for $100.0 million[109] - The company has repurchased a total of 10,029,687 shares for approximately$128.8 million under its share repurchase program, with $71.2 million remaining available[157]