Dynavax is Already Delivering Significant Long Term Stockholder Value Through Execution of Current Strategy Overseen by Board; Deep Track's Inferior Short-Term Plan and Nominees are Not in the Best Interests of All Stockholders Glass Lewis' Recommendation Recognizes the Significant Stockholder Value Creation and Differentiated Capital Return Overseen by the Dynavax BoardReiterates ISS and Egan Jones Recommendations that Stockholders Support ALL Dynavax Nominees and Deep Track Board Representation is Not War ...

Dynavax (DVAX) FY Conference June 03, 2025 03:40 PM ET Speaker0 Analyst here at William Blair. Thank you all for coming, part of our forty fifth Annual Growth Stock Conference. Happy to introduce Dynavax and Ryan Spencer, CEO. We're to talk a little bit about the continued growth of HEPLISAV. It's been becoming a great business for the company and also, I think, a little bit of expansion opportunities that they're evaluating. Please visit williamblair.com for any and all disclosures. And with that, I'll tur ...

EMERYVILLE, Calif., May 28, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at William Blair's 45th Annual Growth Stock Conference on Tuesday, June 3rd at 2:40 p.m. CT.The presentations 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.co ...

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].

Core Insights - Dynavax Technologies has been a focus of investment analysis, particularly regarding its product CpG1018, which is considered a former cash cow for the company [1] Group 1 - The author has been following Dynavax Technologies for many years and has shared insights through articles, emphasizing the learning process of investing [1] - The focus has shifted towards healthcare stocks in recent years, indicating a strategic interest in this sector [1] Group 2 - The author expresses appreciation for reader engagement and shared experiences, highlighting the community aspect of investment discussions [1]

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].

Financial Data and Key Metrics Changes - Dynavax reported its highest ever first quarter net revenue for HEPLISAV B at $65 million, a 36% increase year over year [5][25] - Total revenues for the first quarter reached $68 million, up 34% year over year [25] - HEPLISAV B gross margin improved to 79% from 77% in the same quarter last year [25] - 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 [27][28] - Non-GAAP adjusted EBITDA improved to negative $4 million from negative $7 million year over year [28] Business Line Data and Key Metrics Changes - The retail segment for HEPLISAV B saw a 70% year over year growth in total market dose volume [12][14] - HEPLISAV B's estimated U.S. market share rose to 43% in Q1, up from 41% in the same period last year [15] - The company anticipates continued market share gains throughout 2025, aiming for at least 60% market share by 2030 [16][17] Market Data and Key Metrics Changes - The U.S. adult hepatitis B vaccine market has expanded significantly due to ACIP's universal recommendation, leading to a 16% increase in total market dose volume year over year [12][14] - The company expects the HEPLISAV B market opportunity to peak at over $900 million by 2030 [16] Company Strategy and Development Direction - Dynavax is focused on advancing its development pipeline, leveraging its vaccine adjuvant technology, CpG 1018, with key clinical trial milestones for shingles and plague vaccine programs [5][6] - The company announced new programs in pandemic influenza and Lyme disease, aiming to develop differentiated vaccines with lower risk development pathways [8][9] - The capital allocation strategy includes executing a $200 million share repurchase program while evaluating external opportunities for long-term growth [10][31] 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][31] - The company anticipates a banner year in 2025, supported by strong market growth and ongoing adoption of HEPLISAV B [10][32] - Management highlighted the importance of maintaining a disciplined approach to capital allocation and the potential for long-term growth opportunities [10][31] Other Important Information - The company recorded an allowance for doubtful accounts of $11 million related to a legacy COVID-19 adjuvant commercial supply agreement [27] - The company ended the first quarter with cash, cash equivalents, and marketable securities of $661 million, down from $714 million at the end of 2024 [29] 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, despite good progress [34] Question: How does capital allocation and business development fit into the long-term value creation? - Management emphasized a balanced strategy focusing on leveraging core assets, advancing internal development programs, and returning capital to shareholders [36][37] Question: What contributed to the less seasonality observed in the winter of 2024-2025? - Management noted a purposeful focus by retailers on non-flu vaccines, including hepatitis B, contributing to a strong start in Q1 [42][43] 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 a pivotal program decision [44][46] Question: Any issues with discussions with the FDA regarding new vaccine requirements? - Management indicated that they feel insulated from immediate changes and have had positive interactions with the FDA [50][51] Question: How does the Lyme vaccine compare to competitors? - Management believes their Lyme vaccine can establish a leading market share position due to a more approachable dosing regimen compared to competitors [59][60] Question: Is there an explanation for potentially slower growth in HEPLISAV B revenue? - Management stated that year-over-year comparisons are more appropriate and they expect continued growth in market share [70][71]

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]

Corporate Presentation Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases Advance Differentiated Vaccine Pipeline Identify Strategic Opportunities to Accelerate Growth © Copyright DYNAVAX 2025 3 | May 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 statement ...

Financial Performance - Total revenues for Q1 2025 were $68.164 million, a 34.2% increase from $50.790 million in Q1 2024[18] - Product revenue, net for Q1 2025 was $64.959 million, up 36.0% from $47.845 million in Q1 2024[18] - The net loss for Q1 2025 was $96.099 million, significantly higher than the net loss of $8.721 million in Q1 2024[18] - Net loss for the three months ended March 31, 2025, was $96,099, compared to a net loss of $8,721 for the same period in 2024[26] - The total stock-based compensation expense for the three months ended March 31, 2025, was $14.5 million, compared to $13.0 million for the same period in 2024[125] Cash and Liquidity - Cash and cash equivalents decreased to $51.720 million as of March 31, 2025, down from $95.883 million at December 31, 2024[16] - Total cash and cash equivalents and marketable securities as of March 31, 2025, amounted to $661.336 million, a decrease from $713.834 million as of December 31, 2024[46] - The total cash and cash equivalents, and restricted cash decreased by $44,153 during the three months ended March 31, 2025[26] - As of March 31, 2025, the company had $661.3 million in cash and cash equivalents, expected to fund operations for at least the next 12 months[178] Operating Expenses - Total operating expenses increased to $91.794 million in Q1 2025, compared to $68.559 million in Q1 2024, representing a 33.9% rise[18] - Research and development expenses rose by $5.8 million (43%) from $13.53 million in Q1 2024 to $19.38 million in Q1 2025, driven by increased spending on the Shingles program and new clinical studies[168] - Selling, general and administrative expenses increased by $3.6 million (8%) from $44.07 million in Q1 2024 to $47.66 million in Q1 2025, mainly due to professional consulting and legal expenses related to an ongoing proxy contest[171] Assets and Liabilities - Total assets as of March 31, 2025 were $945.928 million, a decrease from $986.256 million at December 31, 2024[16] - Total liabilities increased to $414.987 million as of March 31, 2025, compared to $389.457 million at December 31, 2024[16] - The accumulated deficit increased to $999.374 million as of March 31, 2025, compared to $903.275 million at December 31, 2024[16] Inventory and Cost of Sales - Total inventories increased to $74.403 million as of March 31, 2025, compared to $70.054 million as of December 31, 2024[49] - Cost of sales related to yield loss during the production process was approximately $3.4 million for the three months ended March 31, 2025, compared to $1.3 million for the same period in 2024[49] - Cost of sales for HEPLISAV-B increased by $2.8 million (26%) from $10.97 million in Q1 2024 to $13.77 million in Q1 2025, primarily due to increased sales volume and inventory write-offs[165][166] Debt and Financing - Following the Refinancing Transaction, the total principal balance of outstanding convertible notes was $265.2 million as of March 31, 2025[71] - A loss on debt extinguishment of $82.1 million was recognized in the statement of operations for the three months ended March 31, 2025[74] - The total principal balance of outstanding Convertible Notes as of March 31, 2025, was $260.5 million, net of a debt discount of $4.7 million[191] Revenue Recognition and Contracts - The company recognized revenue of $2.8 million from the DoD agreement for the three months ended March 31, 2025[69] - The company received approximately $175.0 million in advance payments under the CEPI Agreement, with $60.3 million remaining as an outstanding balance as of March 31, 2025[138][142] - The contract asset balance associated with Clover was $60.3 million as of March 31, 2025, down from $71.3 million as of December 31, 2024[141] Market and Product Development - The company is advancing a pipeline of differentiated vaccine candidates, including programs for shingles and a plague vaccine funded by the U.S. Department of Defense[29] - HEPLISAV-B is the only two-dose hepatitis B vaccine for adults approved in the U.S., EU, and UK, demonstrating faster and higher rates of protection compared to a three-dose vaccine[135] - The company plans to conduct an observational retrospective cohort study to support the sBLA filing for a HEPLISAV-B vaccine regimen for adults on hemodialysis[151] Tax and Regulatory Matters - The effective tax rate for the three months ended March 31, 2025, was approximately 1.8%, significantly lower than the 24.2% effective tax rate for the same period in 2024[126] - The FDA issued a Complete Response Letter for the supplemental Biologics License Application for HEPLISAV-B for adults on hemodialysis, and the company plans to resubmit in 2025[206] Share Repurchase and Stock Activity - The company had $120.0 million remaining under the at-the-market Sales Agreement with Cowen and Company, LLC as of March 31, 2025[108] - The share repurchase program authorized by the Board of Directors allows for the repurchase of up to $200.0 million worth of common stock, with an accelerated share repurchase agreement executed for $100.0 million[109] - The company has repurchased a total of 10,029,687 shares for approximately $128.8 million under its share repurchase program, with $71.2 million remaining available[157]