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Dynavax (DVAX) FY Earnings Call Presentation
2025-07-04 09:05
William Blair 45th Annual Growth Stock Conference Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases June 2025 Nasdaq: DVAX Forward-Looking Statements 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 quarter ended M ...
Dynavax Stockholders Elect All Dynavax Director Nominees at 2025 Annual Meeting
Prnewswire· 2025-06-11 15:01
EMERYVILLE, Calif., June 11, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) ("Dynavax" or the "Company"), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that, based on the preliminary vote count provided by its proxy solicitor following the Company's 2025 Annual Meeting of Stockholders ("Annual Meeting"), Dynavax stockholders have voted to elect all four of its director nominees – Brent MacGregor, Scott Myers, Lauren Sil ...
Dynavax Urges Stockholders to Support Its Director Nominees at June 11 Annual Meeting
Prnewswire· 2025-06-09 11:30
Core Viewpoint - Dynavax Technologies Corporation emphasizes the importance of re-electing its four director nominees to maintain strategic leadership and long-term stockholder value, contrasting this with the detrimental plans proposed by Deep Track [2][3][4]. Company Strategy and Performance - Since 2019, Dynavax has successfully repositioned its business, leading to significant stockholder value, with a total return of 203% over the last five years, outperforming vaccine peers (9% return) and the S&P Biotechnology Select Industry Index (-17% decline) [2][4]. - The company has generated over $950 million in revenue between 2020 and 2022, supported by a disciplined capital allocation plan, including over 85% execution of a $200 million share repurchase program authorized in November 2024 [4]. Board Composition and Qualifications - The current board, which includes nominees Brent MacGregor, Scott Myers, Lauren Silvernail, and Elaine Sun, possesses essential strategic leadership and expertise in vaccines, biotechnology, and finance, which are critical for the company's long-term strategy [3][5]. - The board has been reshaped with new independent directors, ensuring that six of the eight directors appointed since 2020 bring specialized skill sets aligned with Dynavax's strategic goals [5]. Opposition to Deep Track - Deep Track's candidates are criticized for lacking the necessary experience in corporate strategy and operations, with their proposed plan seen as a threat to Dynavax's long-term growth potential [2][3]. - Independent proxy advisory firms ISS and Egan-Jones have recommended stockholders support Dynavax's nominees, highlighting concerns over Deep Track's misleading materials and lack of a compelling case for change [4][5].
Dynavax Comments on Glass Lewis Recommendation
Prnewswire· 2025-06-04 20:59
Core Viewpoint - Dynavax Technologies Corporation is emphasizing the effectiveness of its current board and strategic direction, asserting that it has created significant long-term stockholder value, particularly through its focus on vaccine development and capital return strategies [1][2][3]. Company Strategy and Performance - Dynavax's strategic pivot in 2019 towards vaccines has led to substantial stockholder value creation, with a reported total return of 203% over the last five years, significantly outperforming vaccine peers (9%) and the S&P Biotechnology Select Industry Index (-17%) [2][3]. - The company has achieved market leadership with its HEPLISAV-B® vaccine, generating $268 million in net product revenue in 2024 and capturing a 44% market share in the U.S. adult hepatitis B vaccine market [2][3]. - In the first quarter of 2025, HEPLISAV-B® net product revenue reached $65 million, reflecting a 36% year-over-year increase, contributing to total revenue of $68.2 million, a 34% increase year-over-year [2][3]. Board Composition and Governance - The board has undergone significant refreshment, with six of the eight independent directors appointed since 2020, ensuring a balanced mix of experience and expertise in the healthcare sector [2][9]. - Dynavax's nominees for the board, including Brent MacGregor, Scott Myers, Lauren Silvernail, and Elaine Sun, are highlighted as possessing critical expertise necessary for guiding the company through pivotal developments [4][5]. Capital Return Strategy - As of May 5, 2025, Dynavax has executed over 85% of its $200 million share repurchase program, which represents 47% of its capital use, indicating a strong commitment to returning capital to stockholders [9].
Dynavax to Present at William Blair's 45th Annual Growth Stock Conference
Prnewswire· 2025-05-28 20:10
Company Overview - Dynavax Technologies Corporation is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines to combat 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 aged 18 and older, and CpG 1018® adjuvant, utilized in HEPLISAV-B and various adjuvanted COVID-19 vaccines [3] Upcoming Events - Dynavax will present at William Blair's 45th Annual Growth Stock Conference on June 3rd at 2:40 p.m. CT [1] - The presentations will be available via webcast on the "Events & Presentations" page of the company's investor website [2]
Leading Independent Proxy Advisory Firm ISS Recommends Stockholders Vote "FOR" All Four of Dynavax's Highly Qualified Director Nominees
Prnewswire· 2025-05-23 17:44
Core Viewpoint - Institutional Shareholder Services (ISS) recommends Dynavax stockholders vote "FOR" all four of the Company's director nominees, indicating there is no compelling case for change in the current board or strategy [1][2]. Company Strategy and Board Composition - Dynavax's current strategy is recognized as the best path for long-term stockholder value creation, with a proactive board refreshment process in place [2][4]. - The director nominees possess significant expertise in strategic leadership, vaccine development, and biotechnology, which are essential for the Company's success [3][5]. Response to Dissident Campaign - Dynavax criticizes Deep Track's materials as misleading and lacking a solid case for change, emphasizing the board's commitment to long-term growth and value creation [4][6]. - The board has made ongoing refreshment efforts, with six of the nine directors appointed since 2020, demonstrating a commitment to evolving leadership [4][6]. Financial Performance and Market Position - Dynavax has generated over $950 million in revenue through its COVID-19 business development and has a strong position in the adult U.S. hepatitis B vaccine market with HEPLISAV-B [5][6]. - The Company has delivered a total return of 203% to stockholders over the last five years, indicating the effectiveness of its strategy [6]. Call to Action for Stockholders - Dynavax urges stockholders to vote "FOR" all four director nominees on the GOLD proxy card, emphasizing the importance of every vote [7].
Dynavax Issues Statement and Mails Letter to Stockholders Emphasizing Record Financial Results and Continued Momentum
Prnewswire· 2025-05-07 20:45
Core Viewpoint - Dynavax Technologies Corporation criticizes Deep Track Capital's investor presentation, asserting that it lacks understanding of the biotechnology sector and prioritizes short-term gains over long-term value creation [1][3]. Financial Performance - Dynavax reported total revenue of $68.2 million for Q1 2025, a 34% increase from $50.8 million in Q1 2024 [13]. - HEPLISAV-B® generated net product revenue of $65 million, marking a 36% increase compared to $47.8 million in Q1 2024 [13]. - The company expects to achieve full-year revenue guidance of $305 to $325 million [13]. - Adjusted EBITDA improved to negative $4 million from negative $7 million in Q1 2024, with expectations of at least $75 million in 2025 [13]. Strategic Direction - Dynavax emphasizes a balanced strategic plan that includes both internal and external growth opportunities while returning capital to stockholders [2][11]. - The company has executed over 85% of its $200 million share repurchase program, completing $172 million as of May 5, 2025 [13]. - Dynavax's market share for HEPLISAV-B® increased to approximately 43% from 41% in Q1 2024 [13]. Board and Governance - Dynavax urges stockholders to vote for its four director nominees, asserting that they possess superior qualifications compared to Deep Track's candidates [5][10]. - The current Board is described as highly qualified and refreshed, overseeing the company's successful strategic execution [4][11]. Growth Initiatives - Dynavax is advancing its differentiated vaccine pipeline, leveraging its proprietary CpG 1018 adjuvant [8][9]. - New pipeline programs are being initiated alongside ongoing shingles and plague vaccine programs [8].
Dynavax(DVAX) - 2025 Q1 - Earnings Call Transcript
2025-05-06 20:30
Financial Data and Key Metrics Changes - Dynavax reported its highest ever first quarter net revenue for HEPLISAV B at $65 million, a 36% increase compared to the previous year [5][14] - Total revenues for the first quarter reached $68 million, up 34% year over year [26] - HEPLISAV B gross margin improved to 79% from 77% in the same quarter last year, with expectations of approximately 80% for the full year 2025 [26] - GAAP net loss for the first quarter was $96 million, compared to a net loss of $9 million in the first quarter of the previous year, primarily due to debt refinancing accounting treatment [28][29] - Non-GAAP adjusted EBITDA improved to negative $4 million from negative $7 million year over year [29] Business Line Data and Key Metrics Changes - The retail segment for HEPLISAV B saw a significant year-over-year growth of approximately 70% in the first quarter [14] - HEPLISAV B's estimated U.S. market share rose to 43% in Q1, up from 41% in the same period last year [16] - The company executed over 85% of its $200 million share repurchase program as of May 5, 2025 [11][30] Market Data and Key Metrics Changes - The total market dose volume for hepatitis B vaccines increased approximately 16% year over year [13] - The company anticipates HEPLISAV B market opportunity to peak at over $900 million by 2030, capturing at least 60% market share [17] Company Strategy and Development Direction - Dynavax aims to leverage its vaccine adjuvant technology, CpG 1018, to advance its development pipeline, including shingles and plague vaccine programs, as well as new programs in pandemic influenza and Lyme disease [5][9][10] - The company maintains a disciplined approach to capital allocation while evaluating external opportunities to generate long-term growth [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the top half of the annual revenue guidance range for HEPLISAV B due to strong early performance [5][32] - The company expects continued market share gains throughout 2025, supported by strong growth in retail and other key customer segments [17] Other Important Information - The company plans to initiate a phase one/two trial for its pandemic influenza adjuvant program in the coming weeks [9][24] - The Lyme disease vaccine program is expected to enter clinical trials in 2027, with a focus on fewer doses or less frequent boosters compared to current candidates [10] Q&A Session Summary Question: Why not officially raise the lower end of guidance if confidence in hitting the upper half? - Management stated it is prudent to maintain the overall guidance range as the year is only one quarter in [35] Question: How does capital allocation and business development fit into the long-term strategy? - Management emphasized a balanced strategy focusing on leveraging core assets while also returning capital to shareholders through share buybacks [36][38] Question: What contributed to less seasonality in the winter of 2024-2025? - Management noted a purposeful focus by retailers on non-flu vaccines, including hepatitis B, contributing to growth [42] Question: Will the upcoming shingles data release be sufficient for a go/no-go decision? - Management clarified that while the data is important, a more comprehensive data package will be needed for pivotal trial decisions [44][46] Question: Any issues with discussions with the FDA regarding new vaccine requirements? - Management indicated that they have not faced significant issues and expect to engage with the FDA at the appropriate stages [50][56] Question: How does the company view the competitive landscape for the Lyme vaccine? - Management believes their product profile will support a leading market share position due to a more approachable dosing regimen [58]
Dynavax Reports First Quarter 2025 Financial Results and Announces New Pipeline Programs
Prnewswire· 2025-05-06 20:01
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]
Dynavax to Report First Quarter 2025 Financial Results and Host Conference Call on May 6, 2025
Prnewswire· 2025-04-22 20:00
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]