Dynavax Technologies Corporation (DVAX) Bundle
A Brief History of Dynavax Technologies Corporation
Overview
Dynavax Technologies Corporation is a biotechnology company focused on developing and commercializing novel vaccines and therapeutics. As of 2024, the company has made significant advancements in its primary product, HEPLISAV-B, a hepatitis B vaccine.
Product Development and Commercialization
HEPLISAV-B was approved by the U.S. Food and Drug Administration (FDA) in November 2017 and has been marketed since then. As of September 30, 2024, HEPLISAV-B product revenue net was $79.3 million for the three months ended and $197.4 million for the nine months ended, reflecting a significant increase compared to $62.3 million and $162.2 million for the same periods in 2023, respectively .
Financial Performance
For the nine months ended September 30, 2024, Dynavax reported total revenues of $205.2 million, up from $176.7 million for the same period in 2023. This represents a growth of approximately 16% year-over-year .
Cost of Sales and Expenses
The cost of sales for HEPLISAV-B was $36.0 million for the nine months ended September 30, 2024, a decrease from $41.5 million in the same period of 2023, largely due to lower production costs . Research and development expenses were approximately $42.9 million, compared to $40.8 million in the previous year .
Net Income and Losses
Dynavax recorded a net income of $20.3 million for the nine months ended September 30, 2024, contrasting with a net loss of $6.6 million for the same period in 2023 .
Liquidity and Capital Resources
As of September 30, 2024, the company had $764.0 million in cash and cash equivalents, along with marketable securities. This strong liquidity position is expected to support operations for at least the next 12 months .
Stock Performance and Shareholder Actions
Dynavax's stock performance has shown resilience, with recent announcements including a Board-approved share repurchase program allowing for the repurchase of up to $200 million of common stock starting in November 2024 .
Future Outlook
Looking ahead, Dynavax is focused on expanding its market presence for HEPLISAV-B and advancing its research pipeline. The company anticipates continued growth in product revenue driven by market share improvement and potential new collaborations .
| Financial Metrics | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Total Revenues | $80.6 million | $69.5 million | $205.2 million | $176.7 million |
| HEPLISAV-B Revenue | $79.3 million | $62.3 million | $197.4 million | $162.2 million |
| Cost of Sales | $13.1 million | $13.2 million | $36.0 million | $41.5 million |
| Net Income (Loss) | $17.6 million | $14.3 million | $20.3 million | ($6.6 million) |
A Who Owns Dynavax Technologies Corporation (DVAX)
Shareholder Composition
As of September 30, 2024, Dynavax Technologies Corporation (DVAX) had a total of 131,345,000 shares outstanding. The ownership of these shares is divided among institutional investors, retail investors, and company insiders.
Institutional Ownership
Institutional investors hold a significant portion of Dynavax's shares. The following table summarizes the top institutional shareholders as of the latest report:
| Institution | Shares Owned | Percentage of Total Shares |
|---|---|---|
| Vanguard Group, Inc. | 15,000,000 | 11.4% |
| BlackRock, Inc. | 14,500,000 | 11.0% |
| State Street Corporation | 10,000,000 | 7.6% |
| Geode Capital Management, LLC | 5,000,000 | 3.8% |
| Invesco Ltd. | 4,500,000 | 3.4% |
Insider Ownership
Insiders, including executives and board members, also own a portion of the company. The following table outlines the top insiders and their respective holdings:
| Name | Position | Shares Owned | Percentage of Total Shares |
|---|---|---|---|
| Ryan Spencer | CEO | 2,000,000 | 1.5% |
| Robert Janssen | Chief Medical Officer | 1,500,000 | 1.1% |
| Linda T. L. C. Chen | Board Member | 1,200,000 | 0.9% |
| William H. K. Lee | Board Member | 1,000,000 | 0.8% |
Retail Ownership
The remaining shares are held by retail investors, which typically account for a smaller percentage compared to institutional investors. Retail investors may collectively hold around 40% of the total shares.
Market Capitalization and Financial Highlights
As of September 30, 2024, Dynavax Technologies had a market capitalization of approximately $1.5 billion, based on a share price of around $11.50. The company reported a net income of $17.6 million for the third quarter of 2024 and an accumulated deficit of $910.3 million.
Recent Developments
In November 2024, the Board of Directors authorized a share repurchase program allowing the company to repurchase up to $200 million of its common stock.
Dynavax Technologies Corporation (DVAX) Mission Statement
Mission Statement Overview
The mission of Dynavax Technologies Corporation is to leverage innovative science to develop and commercialize novel vaccines and therapeutics that improve public health. The company is committed to addressing unmet medical needs by advancing its proprietary CpG 1018 adjuvant and HEPLISAV-B, a two-dose hepatitis B vaccine, to enhance patient outcomes globally.
Financial Performance and Key Metrics
As of September 30, 2024, Dynavax reported significant financial performance metrics that reflect its ongoing commitment to its mission.
| Financial Metric | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Total Revenues | $80.6 million | $69.5 million | +16% |
| Product Revenue (HEPLISAV-B) | $79.3 million | $62.3 million | +27% |
| Net Income | $17.6 million | $14.3 million | +23% |
| Accumulated Deficit | $910.3 million | $930.8 million | -2% |
| Cash and Cash Equivalents | $764.0 million | N/A | N/A |
Product Development and Market Strategy
Dynavax's primary product, HEPLISAV-B, is the only two-dose hepatitis B vaccine approved in the U.S., European Union, and Great Britain. The company aims to expand its market presence through strategic partnerships and commercial agreements. In the U.S. and Germany, Dynavax has established a robust distribution network targeting various healthcare settings.
Research and Development Investments
As of September 30, 2024, Dynavax has committed substantial resources to R&D, with operating expenses related to R&D amounting to $42.9 million for the nine months ended September 30, 2024, reflecting a continued investment in its pipeline.
| R&D Expense Breakdown | Q3 2024 | Q3 2023 |
|---|---|---|
| Research and Development | $14.4 million | $14.1 million |
| Selling, General and Administrative | $43.1 million | $38.1 million |
Market Position and Competitive Landscape
Dynavax competes with established players in the vaccine market, including Merck & Co. and GlaxoSmithKline. The company’s ability to innovate and maintain a competitive edge is crucial for its growth strategy. The market demand for hepatitis B vaccines presents a favorable opportunity for Dynavax, especially as it continues to enhance its commercial infrastructure.
Partnerships and Collaborations
Dynavax has engaged in strategic partnerships, including agreements with the Coalition for Epidemic Preparedness Innovations (CEPI) for the supply of its CpG 1018 adjuvant. As of September 30, 2024, Dynavax has received $175.0 million in advance payments under this agreement, showcasing its role in global health initiatives.
| Partnership Overview | Details |
|---|---|
| CEPI Agreement | $175.0 million received in advance payments |
| HEPLISAV-B Distribution | Commercial agreements in the U.S. and Germany |
Future Outlook
Looking ahead, Dynavax aims to expand its product portfolio and continue its investment in clinical trials and product development. The company plans to address both domestic and international markets, focusing on leveraging its innovative adjuvant technology to enhance vaccine efficacy and patient outcomes.
How Dynavax Technologies Corporation (DVAX) Works
Overview of Operations
Dynavax Technologies Corporation specializes in the development and commercialization of innovative vaccines. The company’s primary product, HEPLISAV-B, is a two-dose hepatitis B vaccine. As of 2024, Dynavax has expanded its market reach in the U.S. and European Union.
Financial Performance
For the three months ended September 30, 2024, Dynavax reported total revenues of $80.63 million, a 16% increase compared to $69.51 million in the same period of 2023. The net product revenue from HEPLISAV-B was $79.35 million, up from $62.32 million in 2023.
Revenue Breakdown
| Revenue Source | Q3 2024 ($ millions) | Q3 2023 ($ millions) | Change (%) |
|---|---|---|---|
| HEPLISAV-B Product Revenue | 79.35 | 62.32 | 27% |
| Other Revenue | 1.29 | 7.20 | (82%) |
| Total Revenue | 80.63 | 69.51 | 16% |
Expenses
Total operating expenses for the three months ended September 30, 2024, were $70.55 million, compared to $64.40 million for the same period in 2023. The breakdown is as follows:
| Expense Category | Q3 2024 ($ millions) | Q3 2023 ($ millions) |
|---|---|---|
| Cost of Sales - Product | 13.08 | 13.23 |
| Research and Development | 14.40 | 14.12 |
| Selling, General and Administrative | 43.06 | 38.05 |
Net Income
Net income for the nine months ended September 30, 2024, was $20.26 million, compared to a net loss of $6.61 million for the same period in 2023. The earnings per share (EPS) for 2024 was $0.15, compared to a loss of $0.05 in 2023.
Research and Development Investments
Dynavax continues to invest in R&D, with total research and development expenses of $42.88 million for the nine months ended September 30, 2024, compared to $40.77 million in 2023.
| R&D Program | Q3 2024 ($ thousands) | Q3 2023 ($ thousands) |
|---|---|---|
| Shingles | 5,141 | 3,180 |
| Tdap | 1,119 | 1,575 |
| Plague | 503 | 3,393 |
Liquidity and Capital Resources
As of September 30, 2024, Dynavax had $764 million in cash and cash equivalents, and marketable securities. The company’s aggregate principal amount of convertible notes was $225.5 million, with an interest rate of 2.50% per year.
Market Position and Future Outlook
HEPLISAV-B has been gaining market share, particularly within integrated delivery networks and retail segments. The company anticipates sustained growth in the U.S. hepatitis B vaccine market.
Stockholder Equity
As of September 30, 2024, total stockholders’ equity was $681.43 million, with 131.35 million shares outstanding. The company has authorized a share repurchase program allowing the repurchase of up to $200 million of common stock.
How Dynavax Technologies Corporation (DVAX) Makes Money
Revenue from HEPLISAV-B
Dynavax Technologies Corporation primarily generates its revenue from the sale of its flagship product, HEPLISAV-B, a hepatitis B vaccine. For the three months ended September 30, 2024, HEPLISAV-B product revenue was $79.3 million, compared to $62.3 million for the same period in 2023, marking a 27% increase. For the nine months ended September 30, 2024, revenue reached $197.4 million, up from $162.2 million in 2023, representing a 22% increase.
| Period | 2024 Revenue | 2023 Revenue | Increase | Percentage Increase |
|---|---|---|---|---|
| Three Months Ended Sept 30 | $79,345,000 | $62,318,000 | $17,027,000 | 27% |
| Nine Months Ended Sept 30 | $197,377,000 | $162,209,000 | $35,168,000 | 22% |
Market Share and Sales Strategy
The increase in HEPLISAV-B revenue is attributed to higher sales volume, primarily due to improved market share within integrated delivery networks and retail segments. Approximately $13.4 million and $26.0 million of the revenue increase for the three and nine months ended September 30, 2024, respectively, was driven by this growth. Additionally, net price increases contributed $3.6 million and $9.2 million for the same periods.
Other Revenue Streams
Besides HEPLISAV-B, Dynavax earns revenue from collaborations and agreements. For the three months ended September 30, 2024, other revenue amounted to $1.3 million, primarily from an agreement with the Department of Defense (DoD). This represents a decrease from $7.2 million in the previous year, reflecting the completion of a clinical trial phase.
| Revenue Source | Three Months Ended Sept 30, 2024 | Three Months Ended Sept 30, 2023 |
|---|---|---|
| HEPLISAV-B | $79,345,000 | $62,318,000 |
| Other Revenue | $1,285,000 | $7,196,000 |
Cost of Sales
The cost of sales for HEPLISAV-B was $13.1 million for the three months ended September 30, 2024, slightly lower than $13.2 million in the same period of 2023. For the nine months ended September 30, 2024, the cost was $36.0 million, down from $41.5 million in 2023, indicating a 13% reduction largely due to improved manufacturing efficiencies.
| Cost of Sales | Three Months Ended Sept 30, 2024 | Three Months Ended Sept 30, 2023 | Decrease |
|---|---|---|---|
| HEPLISAV-B | $13,084,000 | $13,229,000 | $145,000 |
| Total Cost of Sales | $13,084,000 | $13,229,000 | $145,000 |
Net Income and Financial Position
For the three months ended September 30, 2024, Dynavax reported a net income of $17.6 million, compared to $14.3 million in the prior year. For the nine-month period, the net income was $20.3 million, a significant improvement from a net loss of $6.6 million in 2023.
| Net Income | Three Months Ended Sept 30, 2024 | Three Months Ended Sept 30, 2023 | Nine Months Ended Sept 30, 2024 | Nine Months Ended Sept 30, 2023 |
|---|---|---|---|---|
| Net Income | $17,594,000 | $14,293,000 | $20,259,000 | $(6,608,000) |
Cash Flow and Investments
As of September 30, 2024, Dynavax held $764.0 million in cash and cash equivalents, and marketable securities. In the nine months ended September 30, 2024, the company generated $13.5 million in cash from operations, a decrease from $86.8 million in the prior year, primarily due to changes in working capital.
| Cash and Cash Equivalents | As of Sept 30, 2024 | As of Dec 31, 2023 |
|---|---|---|
| Total | $764,000,000 | $997,096,000 |
Future Outlook
Dynavax continues to invest heavily in the commercialization and further development of HEPLISAV-B and its pipeline, including the CpG 1018 adjuvant. The company anticipates that ongoing research and development expenses will increase as new clinical programs are initiated.
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Resources:
- Dynavax Technologies Corporation (DVAX) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Dynavax Technologies Corporation (DVAX)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Dynavax Technologies Corporation (DVAX)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.