Dynavax Technologies (DVAX) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -40%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.01 per share when it actually produced break-even earnings, delivering a surprise of 100%.Over the last four quarters, t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-34207 Dynavax Technologies Corporation (Exact name of registrant as specified in its charter) Delaware 33-0728374 (State or o ...

Exhibit 99.1 Dynavax Reports First Quarter 2024 Financial Results and Provides Business Updates EMERYVILLE, CA – May 8, 2024 – Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results and provided a business update for the quarter ended March 31, 2024. "The first quarter of 2024 saw continued year-over-year growth in quarterly HEPLISAV-B net product revenue. As we expected, growth in the ...

Gilnature Shares of vaccine maker Dynavax Technologies Corporation (NASDAQ:DVAX) continue to trade at the lower end of a $12 to $15 range, which they have more or less maintained since mid-June 2023. The company's core asset (HEPISLAV-B) saw FY23 sales improve 69% over FY22 to $213.3 million, making the company cash flow positive despite the loss of revenue from CpG 1018 in Covid-19 vaccines. With three more CpG 1018 vaccine candidates advancing to or posting data from mid-stage trials in 2024 and HEPIS ...

EMERYVILLE, Calif., Feb. 27, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at TD Cowen's 44th Annual Health Care Conference on Monday, March 4 at 10:30 a.m. ET. The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/even ...

Dynavax Technologies Corporation (NASDAQ:DVAX) Q4 2023 Earnings Conference Call February 22, 2024 4:30 PM ET Company Participants Paul Cox - Vice President, Investor Relations & Corporate Communications Ryan Spencer - Chief Executive Officer Donn Casale - Chief Commercial Officer Rob Janssen - Chief Medical Officer Kelly MacDonald - Chief Financial Officer Conference Call Participants Matthew Phipps - William Blair Jonathan Miller - Evercore ISI Paul Choi - Goldman Sachs Ernesto Rodriguez-Dumont - Cowen Roy ...

Dynavax Technologies (DVAX) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of a loss of $0.01. This compares to earnings of $0.45 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 100%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.01 per share when it actually produced earnings of $0.10, delivering a surprise of 1,100%.Over the last four quarters ...

Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Dynavax's expected financial results and market share as of and for the year and quarter ended December 31, 2023, expectations regarding future growth and market shares, expectations for vaccine markets, the company's strategic priorities, and expectations regarding the timing of IND f ...

HEPLISAV-B® 2023 net product revenue grew 69% year-over-year to $213 million Achieved market leader status in key segments retail pharmacy and IDNs in 2023 2024 HEPLISAV-B net product revenue expected to be $265 - $280 million Cash position increased to $742 million at year end and expect to be cash flow positive for full year 2024 Conference call today at 4:30 p.m. ET/1:30 p.m. PT  EMERYVILLE, Calif., Feb. 22, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopha ...

Financial Performance - HEPLISAV-B product revenue in the U.S. reached $213.3 million for the year ended December 31, 2023, representing a 69% increase compared to 2022[32] - HEPLISAV-B vaccine net product revenue reached $213.3 million in 2023, representing a 69% growth compared to 2022[8] - The company generated $100.6 million in cash from operating activities in 2023, ending the year with $742.3 million in cash and cash equivalents, and marketable securities[8] - The net loss reported for 2023 was $6.4 million[8] - The cumulative translation adjustment reported as of December 31, 2023, was a $3.0 million loss, compared to a $4.0 million loss as of December 31, 2022, primarily related to foreign exchange rate fluctuations[415] - If interest rates were to rise or fall by 100 basis points, the pro forma change in fair value of investments would be $7.0 million as of December 31, 2023, compared to $4.1 million as of December 31, 2022[413] Market Share and Growth Opportunities - HEPLISAV-B's estimated total market share in the U.S. increased to approximately 42% from 35% at the end of 2022[32] - Estimated market share of HEPLISAV-B in the retail pharmacy segment rose to approximately 58%, up from 42% at the end of 2022[32] - The CDC's recommendation for hepatitis B vaccination in adults aged 19-59 is expected to expand the total annual market opportunity to approximately $800 million in the U.S. by 2027[32] - The company aims to increase HEPLISAV-B market share and leverage it as a foundational asset for growth and pipeline development[38] - HEPLISAV-B competes with three-dose hepatitis B vaccines and aims to capture a majority of the U.S. market share[76] Clinical Trials and Product Development - A supplemental Biologic License Application for HEPLISAV-B vaccination of adults on hemodialysis is under priority review by the FDA, with an action date planned for May 13, 2024[32] - The shingles vaccine candidate Z-1018 is set to initiate a Phase 1/2 trial in the first half of 2024 following IND clearance[30] - The Tdap vaccine candidate Tdap-1018 plans to submit an IND for a Phase 2 human challenge study in the second half of 2024[31] - The plague vaccine candidate is currently in a Phase 2 clinical trial, with top line data anticipated in 2024[33] - HEPLISAV-B demonstrated a 95% protection rate in clinical trials, compared to 81% for the competitor Engerix-B[42] - A Phase 1 clinical trial for a shingles vaccine candidate utilizing CpG 1018 adjuvant was completed, showing promising immunogenicity results[51] - The Tdap vaccine candidate adjuvanted with CpG 1018 is anticipated to improve protection durability against whooping cough[54] Regulatory and Compliance - The company is subject to ongoing FDA regulations, including recordkeeping and reporting requirements, which can lead to legal actions if not complied with[84] - The FDA review process for biopharmaceuticals typically takes ten months, or eight months for unmet medical needs, with potential for extensions[83] - The company must comply with EU GMP standards for manufacturing and distribution of medicinal products, with potential sanctions for non-compliance[104] - Conditional marketing authorizations may be granted for products lacking complete safety and efficacy data, valid for one year and renewable annually[102] - The holder of a marketing authorization in the EU must maintain a pharmacovigilance system and report serious adverse reactions[110] - The company may face civil, criminal, or administrative penalties for non-compliance with FDA and EU regulations, impacting its ability to operate[86][105] Supply Chain and Manufacturing - The company relies on a limited number of suppliers for manufacturing, which poses risks to meeting future demand for HEPLISAV-B[18] - The company has a contract with the U.S. Department of Defense for a plague vaccine development, totaling $33.7 million through 2025[61] - The company has fully satisfied its delivery obligations under supply agreements for COVID-19 vaccines as of December 31, 2023[63] - The company continues to explore other programs for the utilization of CpG 1018 adjuvant to enhance immune responses[63] Employee and Organizational Development - The company has 408 employees as of December 31, 2023, with 275 in the U.S. and 133 in Düsseldorf, Germany[145] - The regrettable turnover rate for 2023 was 7% in the U.S. and 5% in Düsseldorf, with average employee tenure of 3.0 years in the U.S. and 6.2 years in Düsseldorf[146] - In 2023, 32 leaders and key contributors completed a leadership development program, an increase from 30 participants in the prior year[149] - The company launched an internal DEI survey to gather information on its Diversity, Equity, and Inclusion initiatives[150] - The company provides a competitive mix of compensation, including base salary, annual cash bonuses, and equity compensation, with equity compensation increasing based on responsibility level[147] - The average cash bonus payout is based on corporate goals and individual performance, with the CEO's bonus solely based on corporate performance[148] - The company has a remote-first working environment in the U.S., which aids in recruiting and retention efforts[146] Legal and Ethical Compliance - The company is subject to various federal and state "sunshine" laws requiring transparency in pricing and marketing practices, which may impose compliance burdens[128] - The company faces potential penalties for non-compliance with federal and state laws, which could adversely affect operations and financial results[130] - The federal Anti-Kickback Statute prohibits remuneration intended to induce referrals for healthcare services, affecting pharmaceutical marketing practices[119] Market Environment and Pricing - Sales of marketed products, particularly HEPLISAV-B, depend on coverage and reimbursement decisions made by third-party payors[131] - The U.S. government and third-party payors are increasingly implementing cost-containment measures, which may limit product sales[132] - The company is affected by healthcare reforms and scrutiny of drug pricing, leading to lower average net selling prices[133] - The Inflation Reduction Act of 2022 includes provisions for negotiating drug prices under Medicare, impacting future pricing strategies[134] - The Health Technology Assessment process in the EU will influence pricing and reimbursement for medicinal products starting in 2025[138] Intellectual Property - The intellectual property portfolio includes over 25 issued U.S. patents and over 65 granted foreign patents, with over 115 pending patent applications related to TLR agonists or antagonists[66] - The patent estate is projected to expire between 2024 and 2043, with specific patents related to HEPLISAV-B expiring in 2032[67]