Financial Performance - Total revenues for Q1 2025 were $68.164 million, a 34.2% increase from $50.790 million in Q1 2024[18] - Product revenue, net for Q1 2025 was $64.959 million, up 36.0% from $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%) from $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%) from $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]

Financial Performance - Dynavax reported record HEPLISAV-B net product revenue of $65 million for Q1 2025, representing a 36% year-over-year growth from $47.8 million in Q1 2024[6]. - Total revenues for Q1 2025 were $68.2 million, a 34% increase compared to $50.8 million in Q1 2024[17]. - Adjusted EBITDA for Q1 2025 was negative $4.4 million, an improvement from negative $6.8 million in Q1 2024[17]. - Total revenues for the three months ended March 31, 2025, were $68.164 million, an increase of 34.2% compared to $50.790 million for the same period in 2024[36]. - Product revenue, net, was $64.959 million, up from $47.845 million, reflecting a growth of 36.0% year-over-year[36]. - The net loss for the three months ended March 31, 2025, was $96.099 million, compared to a net loss of $8.721 million for the same period in 2024[36]. - Adjusted EBITDA for the first quarter of 2025 was $(4.356) million, an improvement from $(6.751) million in the same quarter of 2024[40]. Market Position and Expectations - HEPLISAV-B's total estimated market share in the U.S. increased to approximately 43%, up from 41% in Q1 2024[7]. - The company expects the U.S. hepatitis B adult vaccine market to peak at over $900 million in annual sales by 2030, with HEPLISAV-B projected to achieve at least 60% market share[7]. - Dynavax anticipates HEPLISAV-B net product revenue for the full year 2025 to be in the range of $305 to $325 million[17]. - Dynavax anticipates continued growth and market expansion, with expectations for future financial performance and product commercialization[32]. Expenses and Liabilities - Research and development expenses for Q1 2025 were $19.4 million, compared to $13.5 million in Q1 2024[17]. - Total operating expenses increased to $91.794 million from $68.559 million, representing a rise of 33.9%[36]. - Cash, cash equivalents, and marketable securities decreased to $661.336 million as of March 31, 2025, down from $713.834 million at the end of 2024[38]. - Total current assets were $815.970 million, a decrease from $848.941 million as of December 31, 2024[38]. - Total liabilities increased to $415.987 million from $389.457 million, with total long-term liabilities rising to $346.608 million[38]. - The company reported a significant loss on debt extinguishment of $82.095 million during the quarter[36]. Share Repurchase Program - The company has executed over 80% of its $200 million share repurchase program, with $172 million repurchased as of May 5, 2025[17]. Future Developments - Dynavax plans to initiate a Phase 1/2 clinical trial for an investigational H5N1 influenza vaccine adjuvanted with CpG 1018 in Q2 2025[13].

Core Insights - Dynavax Technologies Corporation reported strong financial results for Q1 2025, achieving a record net product revenue of $65 million for its HEPLISAV-B vaccine, marking a 36% increase year-over-year [6][7][15] - The company is advancing its clinical pipeline, including key milestones for shingles and plague vaccine programs, while also exploring new opportunities in pandemic influenza and Lyme disease [2][4][11] Business Updates - HEPLISAV-B is the first and only adult hepatitis B vaccine approved in the U.S., EU, and UK that requires only two doses for series completion [3] - The U.S. market share for HEPLISAV-B increased to approximately 43%, with expectations for the hepatitis B adult vaccine market to exceed $900 million by 2030 [7][12] Clinical and Preclinical Pipeline - Dynavax is developing Z-1018, an investigational shingles vaccine for adults aged 50 and older, with top-line results expected in Q3 2025 [5][8] - The company is also collaborating with the U.S. Department of Defense on a plague vaccine candidate, with a new agreement worth approximately $30 million [9] - Plans for a pandemic influenza adjuvant program and a Lyme disease vaccine are set to enter clinical development in 2025 and 2027, respectively [10][11] Financial Highlights - Total revenues for Q1 2025 were $68.2 million, a 34% increase from $50.8 million in Q1 2024 [15] - GAAP net loss for Q1 2025 was $96.1 million, primarily due to a loss on debt extinguishment [23] - Cash, cash equivalents, and marketable securities totaled $661.3 million as of March 31, 2025 [23] Full Year 2025 Financial Guidance - Dynavax reaffirmed its full-year 2025 financial guidance, expecting HEPLISAV-B net product revenue to be in the range of $305 to $325 million [17][23]

Core Viewpoint - Dynavax Technologies Corporation is urging stockholders to vote "FOR" its four director nominees in the upcoming Annual Meeting, emphasizing the importance of maintaining a qualified board to support the company's strategic direction and long-term value creation [1][2][9] Group 1: Board Composition and Qualifications - The Dynavax Board has been significantly refreshed, with six of the eight independent directors appointed since 2020, enhancing corporate governance and operational performance [3][4] - The current board members possess extensive industry knowledge and experience, with 9 out of 9 having operational and commercial experience, and 7 out of 9 having vaccine experience [4] - The four nominees—Brent MacGregor, Scott Myers, Lauren Silvernail, and Elaine Sun—bring a wealth of expertise across various facets of biotechnology and vaccine development, crucial for guiding the company [6] Group 2: Financial Performance and Strategy - Dynavax has achieved total stockholder returns of 267% over the past five years, significantly outperforming the NASDAQ Biotechnology Index and the S&P Biotechnology Select Industry Index [4] - The commercialization of HEPLISAV-B® has been highly successful, generating a record $268 million in net product revenue in 2024, with expectations of $305-$325 million in 2025 [4] - The company is advancing a differentiated pipeline, including a shingles vaccine targeting a $4.4 billion market and a plague vaccine with a Phase 2 trial expected to start in Q3 2025 [4] Group 3: Capital Strategy - Dynavax is executing a $200 million share repurchase program, with $128.8 million already completed as of Q1 2025, demonstrating a commitment to returning capital to stockholders [5] - The company has refinanced a majority of its outstanding Convertible Senior Notes, strengthening its capital structure and reducing the overall cost of capital [5] Group 4: Opposition to Deep Track Capital - Deep Track Capital is seeking to replace four independent directors, which Dynavax argues would be detrimental to the company's long-term value and momentum [2][7] - The board asserts that Deep Track's proposals lack actionable ideas for growing HEPLISAV-B® and prioritize short-term interests over sustainable growth [8][9] - The qualifications of Dynavax's nominees are highlighted as superior to those of Deep Track's candidates, who have limited public company board experience [6][7]

Core Viewpoint - Dynavax Technologies Corporation will report its first quarter 2025 financial results on May 6, 2025, after U.S. financial markets close [1] Group 1: Financial Reporting - The financial results will be announced on May 6, 2025, followed by a conference call and live audio webcast at 4:30 p.m. ET/1:30 p.m. PT [1] - Participants can access the live audio webcast through the "Events & Presentations" page on the Company's website, with a replay available for 30 days [2] Group 2: Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines against infectious diseases [3] - The Company has two commercial products: HEPLISAV-B® vaccine, approved in the U.S., EU, and UK for hepatitis B prevention in adults, and CpG 1018® adjuvant, used in HEPLISAV-B and multiple COVID-19 vaccines [3]

Urges Stockholders to Vote "FOR" All Four Dynavax Director Nominees on the GOLD Proxy Card Highlights Record Financial and Operational Results, Balanced Capital Allocation Strategy andMeaningful Board Refreshment Underscores Deep Track's Value Destructive, Short-Term Focus and Unnecessary Proxy Contest EMERYVILLE, Calif., April 17, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) ("Dynavax" or the "Company"), a commercial-stage biopharmaceutical company developing and commercializing inn ...

Dynavax's Board is Overseeing Record Operational and Financial Performance Outlines Extensive Engagement with Deep Track and Multiple Attempts to Reach a Resolution EMERYVILLE, Calif., April 3, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) ("Dynavax" or the "Company"), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today filed its preliminary proxy materials with the Securities and Exchange Commission ("SEC") in connection with its upc ...

One stock that might be an intriguing choice for investors right now is Dynavax Technologies Corporation (DVAX) . This is because this security in the Medical - Biomedical and Genetics space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is argua ...

Opportunistic refinancing extends the maturity of most of existing debt with improved terms and reduces dilution to existing capital structure $225 million of convertible notes due in 2030 issued, including an exchange for the retirement of ~$185 million of existing convertible notes due in 2026 and ~$40 million of new money Dynavax repurchased ~$8 million of the Company's common stock in connection with this transactionEMERYVILLE, Calif., March 6, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nas ...

Core Insights - Dynavax Technologies Corporation (NASDAQ: DVAX) reported decent Q4 results in late February and provided solid initial guidance for FY 2025 [2] Group 1: Company Performance - The company posted decent Q4 results, indicating a positive performance trend [2] - Initial guidance for FY 2025 appears solid, suggesting potential for growth [2] Group 2: Investment Opportunities - The Biotech Forum is focusing on buy-write opportunities, indicating a strategic approach to trading in the biotech sector [1] - The forum offers a model portfolio featuring 12-20 high upside biotech stocks, which may present investment opportunities [2]