Dynavax(DVAX)
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Dynavax(DVAX) - 2023 Q3 - Earnings Call Presentation
2023-11-02 23:08
Forward-Looking Statements © Copyright DYNAVAX 2023 2 | Q3 2023 Business Highlights Ryan Spencer Chief Executive Officer Clinical Pipeline Update Robert Janssen Chief Medical Officer Q&A Session Dynavax Core Strategic Priorities • Increase market share to become the market leader by 2027 • Deliver on our innovative and diversified pipeline leveraging CpG 1018® adjuvant with proven antigens | --- | --- | |--------------------|-------| | | | | | | | Identify Strategic | | | Opportunities to | | | Accelerate G ...
Dynavax(DVAX) - 2023 Q3 - Earnings Call Transcript
2023-11-02 23:07
Start Time: 16:30 January 1, 0000 4:59 PM ET Dynavax Technologies Corporation (NASDAQ:DVAX) Q3 2023 Earnings Conference Call November 02, 2023, 16:30 PM ET Company Participants Ryan Spencer - CEO Donn Casale - Chief Commercial Officer Rob Janssen - Chief Medical Officer Kelly MacDonald - CFO Paul Cox - VP of IR and Corporate Communications Conference Call Participants Matthew Phipps - William Blair Ernesto Rodriguez-Dumont - TD Cowen Jonathan Miller - Evercore ISI Roy Buchanan - JMP Securities Operator Good ...
Dynavax(DVAX) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . 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 September 30, 2023 Commission file number: 001-34207 Dynavax Technologies Corporation (Exact name of registrant as specified in its charter) Delaware 33-0728374 (State ...
Dynavax(DVAX) - 2023 Q2 - Earnings Call Transcript
2023-08-03 23:25
Financial Data and Key Metrics Changes - Dynavax reported total revenues of $60 million for Q2 2023, with HEPLISAV-B net product revenue of $56 million, reflecting a 73% year-over-year growth [44][35] - The company raised its full-year revenue expectations for HEPLISAV-B to a range of $200 million to $250 million, up from the previous range of $165 million to $185 million, indicating a projected growth of 58% to 70% year-over-year [32][44] - Gross margins for HEPLISAV-B improved to approximately 76% in Q2 2023, compared to about 69% in the same period last year [20][44] Business Line Data and Key Metrics Changes - HEPLISAV-B's market share increased to approximately 39% in the overall hepatitis B vaccine market, up from 32% a year ago [9] - In the Integrated Delivery Networks (IDN) segment, HEPLISAV-B's market share rose to approximately 53%, compared to 39% at the end of Q2 2022 [10] - Dose volume for HEPLISAV-B in the retail pharmacy segment increased by 78% year-over-year, although market share remained consistent at 45% [36][37] Market Data and Key Metrics Changes - The hepatitis B vaccine market in the U.S. is estimated to grow to over $800 million by 2027, driven by the ACIP's universal recommendation for hepatitis B vaccination [34] - The overall hepatitis B vaccine market grew approximately 40% year-over-year in Q2 2023 [9] Company Strategy and Development Direction - The company is focusing on external opportunities in commercial or late-stage assets in the vaccine space and high-synergy commercial assets within the infectious disease space [33] - Dynavax aims to optimize its sales force to expand promotional reach in the retail pharmacy and IDN segments, which are expected to represent approximately 60% of the hepatitis B market by 2027 [12][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in HEPLISAV-B's market leadership and the continued expansion of the hepatitis B vaccine market, driven by strong commercial execution [13][39] - The company anticipates positive free cash flow for 2023 and believes its current capital is sufficient to support core business growth without needing to return to capital markets [21][54] Other Important Information - The company is advancing its clinical pipeline, including three vaccine candidates for Tdap, Shingles, and Plague, with plans for a Phase 1/2 trial initiation in early 2024 [16][41] - Dynavax established a Scientific Advisory Board to support its vaccine research and development efforts [18] Q&A Session Summary Question: Market growth expectations for hepatitis B - Management noted that market growth is accelerating faster than previously forecasted, particularly in retail and IDN segments [56] Question: HEPLISAV gross margins outlook - Management indicated that gross margins are expected to remain in the mid to high 70s for the year, reflecting improvements from manufacturing investments [61] Question: Tdap nonhuman challenge study details - Management confirmed that the Tdap challenge study is part of a longer-term development plan and will help establish a model for testing efficacy in humans [77][87] Question: Commercial optimization strategies - Management discussed optimizing the sales force to engage at various levels within retail chains to drive recommendations for hepatitis B vaccination [92]
Dynavax(DVAX) - 2023 Q2 - Earnings Call Presentation
2023-08-03 21:39
| --- | --- | --- | --- | --- | |------------------------------------------------------------------------------------------------------|-------|-------|-----------------------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Second Quarter 2023 Financial Results | | | | | | | | | | | | Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases | | | | | | | | | August 3, 2023 Nasdaq: DVAX | | Statements contained in this presentation regard ...
Dynavax(DVAX) - 2023 Q2 - Quarterly Report
2023-08-02 16:00
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, 2023 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 ot ...
Dynavax(DVAX) - 2023 Q1 - Earnings Call Transcript
2023-05-02 23:33
Dynavax Technologies Corporation (NASDAQ:DVAX) Q1 2023 Earnings Conference Call May 2, 2023 4:30 PM ET Company Participants Paul Cox - VP of IR and Corporate Communications Ryan Spencer - CEO Donn Casale - Chief Commercial Officer Rob Janssen - Chief Medical Officer Kelly MacDonald - CFO Conference Call Participants Matthew Phipps - William Blair Joshua Schimmer - Evercore ISI Roy Buchanan - JMP Securities Ed White - H.C. Wainwright Ernie Rodriguez - TD Cowen Operator Good day ladies and gentlemen. And welc ...
Dynavax(DVAX) - 2023 Q1 - Quarterly Report
2023-05-01 16:00
Financial Performance - Total revenues for Q1 2023 were $46.9 million, a decrease of 58.8% compared to $114.0 million in Q1 2022[18] - Product revenue, net for Q1 2023 was $43.5 million, down 61.3% from $112.3 million in Q1 2022[18] - The net loss for Q1 2023 was $24.3 million, compared to a net income of $32.9 million in Q1 2022[18] - Basic net loss per share attributable to common stockholders was $0.19 for Q1 2023, compared to earnings of $0.26 per share in Q1 2022[18] - Total revenues for the three months ended March 31, 2023, were $46.925 million, compared to $113.992 million for the same period in 2022, representing a decrease of approximately 59.0%[81] - HEPLISAV-B product revenue for Q1 2023 was $43.451 million, up from $20.810 million in Q1 2022, indicating a growth of approximately 108.5%[81] - The company reported a net loss of $24.332 million for Q1 2023, compared to a net income of $32.859 million in Q1 2022, reflecting a significant decline in profitability[89] Operating Expenses - Total operating expenses for Q1 2023 were $77.2 million, a decrease of 6.3% from $83.2 million in Q1 2022[18] - Stock-based compensation expense increased to $10.034 million in Q1 2023, up from $7.646 million in Q1 2022[26] - The company reported a bad debt expense of $12.313 million for the quarter, which was not present in the same period last year[26] - Selling, general and administrative expenses for stock-based compensation increased to $6.830 million in Q1 2023, compared to $5.427 million in Q1 2022, reflecting a rise of about 25.8%[106] - Research and development expenses related to stock-based compensation rose to $2.112 million in Q1 2023, up from $1.276 million in Q1 2022, indicating a growth of approximately 65.3%[106] Cash and Assets - Cash and cash equivalents decreased to $174.4 million as of March 31, 2023, from $202.0 million at December 31, 2022[16] - Total assets as of March 31, 2023, were $969.9 million, down from $985.9 million at December 31, 2022[16] - Total stockholders' equity decreased to $563.7 million as of March 31, 2023, from $581.0 million at December 31, 2022[16] - Total cash and cash equivalents and marketable securities as of March 31, 2023, amounted to $651.956 million, a slight increase from $624.395 million as of December 31, 2022[41] Liabilities and Equity - Total liabilities increased slightly to $406.2 million as of March 31, 2023, compared to $404.8 million at December 31, 2022[16] - The accumulated deficit as of March 31, 2023, was $948.5 million, an increase from $924.2 million at December 31, 2022[16] - The aggregate principal amount of convertible senior notes was $225.5 million as of March 31, 2023, excluding a debt discount of $3.6 million[51] - The company issued $225.5 million in convertible senior notes with a 2.50% interest rate, maturing on May 15, 2026, and recorded at a fair value of $269.1 million as of March 31, 2023[76] Clinical and Product Development - The company has advanced a multi-program clinical pipeline leveraging its proprietary CpG 1018 adjuvant, with ongoing Phase 1 and Phase 2 clinical trials[28] - As of March 31, 2023, Dynavax satisfied all delivery obligations under its global commercial supply agreements for COVID-19 vaccines[28] - Dynavax is collaborating with the U.S. Department of Defense on a Phase 2 clinical trial for plague, fully funded by the DoD[28] - The U.S. Department of Defense agreement for a recombinant plague vaccine adjuvanted with CpG 1018 adjuvant is valued at approximately $22.0 million over two and a half years, with revenue recognized of $3.5 million for the three months ended March 31, 2023[67] Stock and Shareholder Information - As of March 31, 2023, there were 128,471,773 shares of common stock outstanding, with a weighted average of 127,921 shares for basic net loss per share calculations[91] - The company had $120.5 million remaining under the 2020 ATM Agreement for potential future stock sales[92] - The total number of stock options outstanding as of March 31, 2023, was 10,735,000, with a weighted average exercise price of $10.56[98] - The company granted 2,152,000 restricted stock units (RSUs) during Q1 2023, with a weighted average grant-date fair value of $11.06 per share[99] Tax and Fair Value - The effective tax rate for the three months ended March 31, 2023, was approximately (2.6)%, compared to 0% for the same period in 2022[107] - A provision for income taxes of $0.6 million was recorded for the three months ended March 31, 2023, while no provision was recorded in the same period of 2022[107] - The fair value of stock options granted in Q1 2023 was estimated at $7.28 per share, down from $8.05 in Q1 2022[103] - The risk-free interest rate used in fair value calculations increased to 4.0% for stock options in Q1 2023, compared to 1.9% in Q1 2022[103]
Dynavax(DVAX) - 2022 Q4 - Earnings Call Transcript
2023-02-24 00:27
Dynavax Technologies Corporation (NASDAQ:DVAX) Q4 2022 Results Conference Call February 23, 2023 4:30 PM ET Company Participants Nicole Arndt - Senior Manager, IR Ryan Spencer - CEO Donn Casale - SVP, Commercial Rob Janssen - Chief Medical Officer Kelly MacDonald - CFO Conference Call Participants Phil Nadeau - Cowen & Company Madhu Kumar - Goldman Sachs Matthew Phipps - William Blair Roy Buchanan - JMP Securities Operator Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarte ...
Dynavax(DVAX) - 2022 Q4 - Annual Report
2023-02-22 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ 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) (State or other jurisdiction of incorpora ...