Workflow
Dynavax(DVAX)
icon
Search documents
Dynavax Technologies (DVAX) Tops Q2 Earnings Estimates
ZACKS· 2024-08-07 00:10
Dynavax Technologies (DVAX) came out with quarterly earnings of $0.08 per share, beating the Zacks Consensus Estimate of $0.06 per share. This compares to earnings of $0.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 33.33%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.05 per share when it actually produced a loss of $0.07, delivering a surprise of -40%. Over the last four qua ...
Dynavax(DVAX) - 2024 Q2 - Quarterly Report
2024-08-06 20:10
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 June 30, 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 othe ...
Dynavax(DVAX) - 2024 Q2 - Quarterly Results
2024-08-06 20:05
DYNAVAX Exhibit 99.1 Dynavax Reports Second Quarter 2024 Financial Results and Provides Business Updates • Achieved record quarterly HEPLISAV-B® net product revenue of $70.2 million, growing 24% year-overyear • Reaffirming full year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million • Initiated dosing in Phase 1/2 trial of novel shingles vaccine program with clinical data expected in 2H 2025 • Conference call today at 4:30 p.m. ET/1:30 p.m. PT EMERYVILLE, CA – August 6, 2024 – Dynavax Techn ...
Dynavax to Report Second Quarter 2024 Financial Results and Host Conference Call on August 6, 2024
Prnewswire· 2024-07-23 20:00
EMERYVILLE, Calif., July 23, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report second quarter 2024 financial results on Tuesday, August 6, 2024, after the U.S. financial markets close. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/events-presentations. A replay o ...
Dynavax Initiates Phase 1/2 Study of Novel Shingles Vaccine Program
Prnewswire· 2024-06-27 20:09
"We believe there is an opportunity to develop an improved shingles vaccine with a significantly better tolerability profile compared to the market-leading shingles vaccine. One of the unique advantages of our vaccine candidate is CpG 1018 adjuvant's established safety and tolerability profile, combined with its ability to induce strong CD4+ T-cell responses, which are thought to be critical in preventing the reactivation of the herpes zoster virus," said Rob Janssen, M.D., Chief Medical Officer of Dynavax. ...
Dynavax to Present at Upcoming Investor Conferences
prnewswire.com· 2024-05-28 20:18
EMERYVILLE, Calif. , May 28, 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 the following upcoming investor conferences during the month of June: William Blair 44th Annual Growth Stock Conference on Tuesday, June 4 at 1:20 p.m. CT Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10 at 4:00 p.m. ET The presentations will ...
Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S.
Prnewswire· 2024-05-14 12:30
EMERYVILLE, Calif., May 14, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) today provided a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support ...
Dynavax(DVAX) - 2024 Q1 - Earnings Call Transcript
2024-05-08 23:51
Financial Data and Key Metrics Changes - Dynavax reported a 10% year-over-year growth in net product revenue for HEPLISAV-B, reaching $48 million in Q1 2024 [18] - The company experienced a net loss of $9 million in Q1 2024, an improvement from a net loss of $24 million in the same period last year [36] - Gross margin for HEPLISAV-B improved to approximately 77% in Q1 2024, up from 66% in Q1 2023 [52] Business Line Data and Key Metrics Changes - HEPLISAV-B's estimated market share increased to approximately 55% in Q1 2024, compared to 49% in the same period last year [12] - Despite a slight decrease in the overall U.S. hepatitis B vaccine market, HEPLISAV-B continued to lead with strong performance in retail pharmacy and integrated delivery networks [28] - The company expects HEPLISAV-B's gross margin to be around 80% for the full year of 2024 [20] Market Data and Key Metrics Changes - The U.S. adult hepatitis B vaccine market is projected to grow to over $800 million by 2027, up from approximately $525 million in 2023 [14] - The company anticipates annual market growth of approximately 10% to 15% over the next several years [30] Company Strategy and Development Direction - Dynavax aims to strengthen its position as a market leader in the adult hepatitis B vaccine market while exploring opportunities to diversify its product portfolio within the infectious disease space [26] - The company is focused on disciplined capital allocation to drive growth and create future commercial opportunities [26] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the adult hepatitis B vaccine market opportunity, noting a recent pickup in market activity as providers shift focus to nonrespiratory vaccines [24] - The company is confident in achieving record sales for HEPLISAV-B in 2024, with net product revenue expected to be between $265 million and $280 million [25] Other Important Information - The company is advancing its innovative vaccine pipeline, including a shingles vaccine and a TdaP vaccine candidate, with several upcoming milestones [10][15] - The company ended Q1 2024 with cash, cash equivalents, and marketable securities of $724 million, which is deemed sufficient to support its current pipeline and operations [54] Q&A Session Summary Question: Retail market share fluctuations - Management noted that slight variations in market share are related to purchasing patterns of larger customers, but they expect to continue gaining market share [57] Question: Shingles program trial design - The shingles trial will include 11 arms, with 40 subjects in each arm, and a placebo-controlled efficacy study is planned [58] Question: Impact of cash balance on decision-making - Management indicated that the immunogenicity data from the shingles program will influence capital management decisions, but they are in a favorable position to fund development programs [60] Question: Seasonality of HEPLISAV-B market - Management expects Q2 and Q3 to be the largest quarters for the adult hepatitis B vaccine market, despite seasonal fluctuations due to respiratory vaccines [68] Question: TdaP Phase II trial timing - The timing of the Phase II trial is contingent on the availability of the PR negative strain, and the delay allows for better understanding of product durability [70]
Dynavax Technologies (DVAX) Reports Q1 Loss, Misses Revenue Estimates
Zacks Investment Research· 2024-05-08 22:21
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 ...
Dynavax(DVAX) - 2024 Q1 - Quarterly Report
2024-05-08 20:10
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 ...