Dynavax (DVAX) FY 2025 Conference September 03, 2025 04:30 PM ET Speaker0Good afternoon. Thank you all for joining and welcome to the Dynavax Technologies fireside chat at the Wells Fargo Healthcare Conference. My name is Jason Ellis. I'm Managing Director on our Healthcare Investment Banking team. I have the distinct pleasure today of having with me Ryan Spencer, Chief Executive Officer and Kelly McDonald, CFO of Dynavax.Ryan, Kelly, thanksSpeaker1for being here. Thank you so much for having us.Speaker0It' ...

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 preventing hepatitis B virus infections 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 participate in a fireside chat at the 2025 Wells Fargo Healthcare Conference on September 3rd at 4:30 p.m. ET [1] - Presentations from the conference will be available via webcast on the "Events & Presentations" page of the company's website [2]

该公司表示，这项研究旨在评估Z-1018与Shingrix在50至69岁人群中的效果，该研究还显示，这款在研 疫苗具有良好的耐受性安全特征。 智通财经APP获悉，Dynavax Technologies(DVAX.US)上涨约7%，此前该公司宣布，其在研带状疱疹疫 苗Z-1018在Ⅰ/Ⅱ期试验中引发的免疫应答与葛兰素史克(GSK.US)的Shingrix疫苗相当。 这家总部位于加州埃默里维尔的生物科技公司援引该临床试验第一部分的顶线数据称，在为试验第二部 分选定的配方和给药方案下，Z-1018的综合疫苗应答率为89.7%，而Shingrix为90.3%。 Dynavax补充道，接受Z-1018接种的受试者中，分别有12.5%和27.5%出现2级或3级局部及全身性注射后 反应;而接受Shingrix接种的受试者中，这一比例分别为52.6%和63.2%。 该Ⅰ/Ⅱ期试验的第二部分将纳入70岁及以上成年人，预计于2025年下半年启动。 ...

Core Insights - Dynavax Technologies Corporation announced positive topline results from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate, showing comparable immune responses to Shingrix in adults aged 50 to 69 years [1][4] Group 1: Clinical Trial Results - Z-1018 achieved a 100.0% humoral vaccine response rate compared to Shingrix's 96.9%, and an 89.7% cellular immune response rate versus Shingrix's 93.5%, resulting in a composite vaccine response rate of 89.7% for Z-1018 and 90.3% for Shingrix [2][8] - The trial demonstrated Z-1018's favorable safety profile, with lower rates of grade 2 and 3 post-injection reactions (PIRs) compared to Shingrix, specifically 12.5% for local PIRs and 27.5% for systemic PIRs for Z-1018 versus 52.6% and 63.2% for Shingrix, respectively [3][10] Group 2: Future Development Plans - Dynavax plans to advance Z-1018 into Part 2 of the Phase 1/2 trial targeting adults aged 70 and older, expected to start in the second half of 2025, using the 100 mcg dose of gE antigen with CpG 1018 and alum [1][7] - The objective of Part 2 is to generate clinical proof-of-concept against Shingrix in the older population, which is crucial for further development [4][7] Group 3: Market Potential - The company aims to disrupt the multi-billion-dollar shingles vaccine market, currently dominated by Shingrix, by developing a product with a potential best-in-class profile [4][5] - Z-1018 is designed to address the age-related decline in immune responses, providing a new option for protection against shingles, a disease affecting approximately 1 in 3 people in their lifetime [11][12]

Live Chat on The Biotech Forum has been dominated by discussion of covered call opportunities in recent quarters. To see what I and the other season biotech investors are targeting as trading ideas in real-time, just initiate your free trial into The Biotech Forum by clicking HERE . Dynavax Technologies Corporation (NASDAQ: DVAX ) reported second quarter results last week. This small- cap biotech concern beat expectations, gave a solid business update, and raised guidance slightly. However, the stock still ...

Dynavax Technologies (DVAX) came out with quarterly earnings of $0.14 per share, beating the Zacks Consensus Estimate of $0.12 per share. This compares to earnings of $0.08 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +16.67%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.03 per share when it actually produced a loss of $0.11, delivering a surprise of -466.67%. Over the last f ...

Financial Data and Key Metrics Changes - Dynavax reported Q2 2025 net product revenue of $92 million, a 31% increase year over year, and total revenues of approximately $95 million, up 29% year over year [5][26] - HEPLISAV B gross margin was 85% for Q2 2025, an increase from 83% in Q2 2024 [27] - GAAP net income for Q2 2025 was $19 million compared to $11 million in Q2 2024, and non-GAAP adjusted EBITDA improved to $37 million from $20 million year over year [28][29] Business Line Data and Key Metrics Changes - HEPLISAV B's estimated market share in the U.S. adult hepatitis B vaccine market rose to 45% in Q2 2025 from 42% in the same period last year [6][12] - Total HEPLISAV B dose volume grew by approximately 13% year over year [12] - The company updated its full year 2025 Hepatitis B net product revenue guidance to $315 million to $325 million, raising the low end of the range [6][30] Market Data and Key Metrics Changes - The U.S. adult hepatitis B vaccine market is experiencing strong momentum due to increasing awareness and higher vaccination rates [11] - Retail segment performance showed a 35% increase in annual dose utilization, with expectations that retail will account for at least 50% of total hepatitis B doses by 2030 [15][18] - The ACIP universal recommendation has transformed the adult hepatitis B vaccine market, creating one of the largest addressable vaccination opportunities in the U.S. [12] Company Strategy and Development Direction - Dynavax aims to achieve at least 60% market share in the U.S. adult hepatitis B vaccine market by 2030, with expectations of double-digit annual growth in product net sales [6][19] - The company is advancing its vaccine pipeline, including a novel shingles program and programs in pandemic influenza and Lyme disease, leveraging its CpG 1018 adjuvant technology [7][21] - A disciplined capital allocation approach is being employed to support HEPLISAV B and advance internal pipeline programs while assessing attractive opportunities [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of HEPLISAV B and the overall market dynamics supporting continued growth [19][20] - The company remains focused on building a robust product portfolio and development pipeline, with a commitment to financial discipline [9][30] - Management highlighted the importance of retail partnerships and recent Medicare policy changes that enhance HEPLISAV B's growth potential [18] Other Important Information - The company completed a $200 million share repurchase program during Q2 2025, retiring over 16 million shares [29] - Cash, cash equivalents, and marketable securities at the end of Q2 2025 were $614 million, down from $714 million at the end of Q2 2024 [29] Q&A Session Summary Question: Inquiry about shingles readout and CD4 T cells - Management confirmed that they will focus on VRR as a composite endpoint at one month, with further assessments at six and twelve months [33][35] Question: HEPLISAV's performance and market share segments - Management clarified that there were no one-time issues affecting HEPLISAV's strong performance, attributing it to widespread adoption, particularly in retail [42][44] Question: Shift to retail and long-term guidance - Management explained that the shift to retail is driven by proactive outreach and aligns with trends seen in other adult vaccines, maintaining confidence in long-term guidance [48][50] Question: Plague program and DoD commitment - Management stated that they are fully aligned with the DoD on the plague program, with funding already awarded through the first half of 2027 [68][70] Question: Lyme disease enrollment and seasonal elements - Management indicated that seasonality will be considered in the clinical development plan for Lyme disease, focusing on safety and immunogenicity in upcoming studies [70]

Core Insights - Dynavax Technologies reported strong Q2 2025 results, with GAAP revenue of $95.4 million, exceeding analyst expectations of $86.7 million, and GAAP diluted EPS of $0.14, surpassing the consensus estimate of $0.10, indicating significant year-over-year growth [1][2][5] Financial Performance - GAAP revenue increased by 29.3% year-over-year from $73.8 million in Q2 2024 to $95.4 million in Q2 2025 [2] - Diluted EPS rose by 75% from $0.08 in Q2 2024 to $0.14 in Q2 2025 [2] - Adjusted EBITDA improved to $37.3 million in Q2 2025, up 81.9% from $20.5 million in Q2 2024 [2] - HEPLISAV-B net product revenue reached $91.9 million, a 30.8% increase from $70.2 million in Q2 2024 [2] Market Position and Strategy - Dynavax's HEPLISAV-B vaccine captured approximately 45% of the U.S. market share, up from 42% a year earlier, with a long-term goal of achieving at least 60% market share by 2030 [5][6] - The company focuses on expanding HEPLISAV-B's market share, advancing its vaccine pipeline, and forming partnerships for commercialization and research [4][11] Clinical Pipeline Progress - Significant advancements were reported in the clinical pipeline, including the shingles vaccine candidate Z-1018, which completed enrollment for a Phase 1/2 trial [7] - The plague vaccine program, in collaboration with the U.S. Department of Defense, is set to advance to Phase 2 trials in the second half of 2025, supported by a $30 million collaboration [7] Financial Guidance - For fiscal 2025, Dynavax raised its HEPLISAV-B net product revenue guidance to a range of $315–$325 million, with a target of at least $75 million in adjusted EBITDA [12] Cash Position and Expenses - As of June 30, 2025, the company had $613.7 million in cash and marketable securities, down from $713.8 million at the end of 2024, primarily due to a $200 million share repurchase program [9][13] - R&D expenses increased by 10.7% to $16.6 million, while SG&A expenses rose by 20.9% to $50.4 million in Q2 2025 compared to the same period in 2024 [9][13]

Earnings Report Q2'25 Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases August 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 June 30, 2025, expectations ...

PART I FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the six months ended June 30, 2025, show a significant increase in total revenues compared to the same period in 2024, primarily driven by HEPLISAV-B sales, despite a net loss of $77.4 million largely due to a one-time $82.1 million loss on debt extinguishment [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and marketable securities | $613,729 | $713,834 | | Accounts receivables, net | $70,699 | $45,281 | | Inventories | $75,687 | $70,054 | | **Total Assets** | **$918,449** | **$986,256** | | **Liabilities & Equity** | | | | Total current liabilities | $118,230 | $78,634 | | Convertible Notes, net | $260,772 | $223,854 | | **Total Liabilities** | **$424,287** | **$389,457** | | **Total Stockholders' Equity** | **$494,162** | **$596,799** | - Total assets decreased primarily due to a reduction in cash and marketable securities, partly used for share repurchases and debt refinancing. Total liabilities increased due to the issuance of new 2030 Convertible Notes, partially offset by the exchange of 2026 Notes[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $95,442 | $73,795 | $163,606 | $124,584 | | Income (Loss) from Operations | $14,429 | $5,198 | $(9,201) | $(12,573) | | Loss on debt extinguishment | $0 | $0 | $(82,095) | $0 | | **Net Income (Loss)** | **$18,721** | **$11,386** | **$(77,378)** | **$2,665** | | Diluted EPS | $0.14 | $0.08 | $(0.63) | $0.02 | - Total revenues grew **29% YoY in Q2 2025** and **31% YoY for the six months ended June 30, 2025**, driven by strong HEPLISAV-B sales. The significant net loss for the first six months of 2025 was primarily caused by a one-time, non-cash loss of **$82.1 million** on debt extinguishment related to the March 2025 refinancing transaction[17](index=17&type=chunk)[72](index=72&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $3,792 | $(5,966) | | Net cash provided by (used in) investing activities | $101,702 | $(25,936) | | Net cash used in financing activities | $(103,800) | $(5,618) | | **Net increase (decrease) in cash** | **$3,252** | **$(37,785)** | - For the first six months of 2025, cash from operations turned positive. Investing activities provided cash due to net proceeds from marketable securities. Financing activities used significant cash for share repurchases (**$100.6 million**) and debt extinguishment payments (**$80.9 million**), partially offset by proceeds from new debt issuance and unwound capped calls[25](index=25&type=chunk) [Notes to Financial Statements](index=10&type=section&id=Notes%20to%20Financial%20Statements) Key notes to the financial statements detail the company's collaborative agreements, a significant debt refinancing transaction, revenue recognition policies, and the completion of its share repurchase program - An allowance for doubtful accounts of approximately **$11.0 million** was recorded relating to the contract asset for Clover, based on an evaluation of credit risk after GAVI terminated its purchase agreement with Clover[60](index=60&type=chunk)[137](index=137&type=chunk) - In March 2025, the company completed a refinancing transaction, issuing **$225.0 million** of 2.00% Convertible Senior Notes due 2030 to exchange and repurchase a portion of its 2.50% Convertible Senior Notes due 2026, resulting in a recognized loss on debt extinguishment of **$82.1 million**[68](index=68&type=chunk)[72](index=72&type=chunk)[151](index=151&type=chunk) - The company completed its **$200.0 million** share repurchase program, repurchasing a total of **16.6 million shares** during the six months ended June 30, 2025, including shares under an Accelerated Share Repurchase (ASR) agreement and through open market transactions[105](index=105&type=chunk)[107](index=107&type=chunk)[156](index=156&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 33% year-over-year revenue growth for the first six months of 2025 to increased HEPLISAV-B sales volume and higher net pricing, while operating expenses rose due to R&D investments and proxy contest costs, leading to a net loss of $77.4 million driven by a debt extinguishment loss [Overview and Pipeline Update](index=28&type=section&id=Overview%20and%20Pipeline%20Update) - The company's strategy focuses on maximizing HEPLISAV-B utilization, expanding its vaccine pipeline using the CpG 1018 adjuvant, and leveraging CpG 1018 supply through collaborations[127](index=127&type=chunk) - Key pipeline programs leveraging the CpG 1018 adjuvant are advancing: - **Shingles (Z-1018):** Top-line immunogenicity and safety data from a Phase 1/2 trial comparing Z-1018 to Shingrix are expected in August 2025 - **Plague:** A new **$30 million** agreement with the DoD will support a Phase 2 trial expected to start in H2 2025 - **Pandemic Influenza (H5N1):** A Phase 1/2 study is ongoing, with data expected to inform formulation selection for Part 2 of the trial - **Lyme Disease:** The vaccine candidate has progressed to IND-enabling studies, with clinical development planned to start in 2027 - **HEPLISAV-B (Hemodialysis):** Engaging with the FDA to finalize the protocol for an observational study to support an sBLA filing for a four-dose regimen[143](index=143&type=chunk)[144](index=144&type=chunk)[149](index=149&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Revenue Comparison (in thousands) | Revenue Source | YTD 2025 | YTD 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | HEPLISAV-B | $156,831 | $118,032 | $38,799 | 33% | | Other revenue | $6,775 | $6,552 | $223 | 3% | | **Total Revenues** | **$163,606** | **$124,584** | **$39,022** | **31%** | - The **$38.8 million** increase in HEPLISAV-B revenue for the first six months of 2025 was driven by higher sales volume (**$17.2 million**), increases in net sales price (**$14.0 million**), and favorable adjustments to the product returns reserve estimate (**$6.8 million**)[163](index=163&type=chunk) Operating Expense Comparison - YTD (in thousands) | Expense Category | YTD 2025 | YTD 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Cost of Sales - Product | $27,804 | $22,952 | $4,852 | 21% | | Research & Development | $35,996 | $28,478 | $7,518 | 26% | | Selling, General & Administrative | $98,037 | $85,727 | $12,310 | 14% | | Bad Debt Expense | $10,970 | $0 | $10,970 | N/A | - R&D expenses increased by **$7.5 million** YTD, primarily due to the shingles Phase 1/2 trial and advancing the pandemic influenza and Lyme disease programs. SG&A expenses increased by **$12.3 million** YTD, mainly driven by **$12.5 million** in professional fees related to a proxy contest[171](index=171&type=chunk)[174](index=174&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$613.7 million** in cash, cash equivalents, and marketable securities. Management believes these funds, along with anticipated HEPLISAV-B revenues, are sufficient to fund operations for at least the next 12 months[181](index=181&type=chunk) - The company completed its **$200.0 million** share repurchase program as of June 30, 2025[184](index=184&type=chunk) - Following the refinancing, the total principal balance of outstanding convertible notes was **$265.2 million**, comprising **$40.2 million** of 2026 Notes (due May 2026) and **$225.0 million** of 2030 Notes (due March 2030)[185](index=185&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states there were no material changes to its market risk disclosures during the six months ended June 30, 2025, as compared to those in its 2024 Annual Report on Form 10-K - No material changes to market risk disclosures were reported for the period[196](index=196&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal controls over financial reporting during the quarter - Management concluded that disclosure controls and procedures are effective at a reasonable assurance level[198](index=198&type=chunk) - No material changes to internal controls over financial reporting were identified during the most recent fiscal quarter[199](index=199&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently aware of any material legal proceedings involving the company - The company reports no material legal proceedings as of the filing date[201](index=201&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The company highlights several material risks, including significant competition for HEPLISAV-B, potential for financial results to vary significantly, and reliance on third parties for manufacturing, alongside new risks from global trade policies, activist stockholders, and financial risks associated with its convertible notes - HEPLISAV-B, the company's first and only marketed product, faces significant competition in the U.S., and its commercial success is not guaranteed[206](index=206&type=chunk) - The company relies on its facility in Germany and third-party suppliers for manufacturing, including a single supplier for the pre-filled syringe presentation of HEPLISAV-B, creating supply chain risk[226](index=226&type=chunk) - A new risk factor was added concerning global trade issues, noting that new tariffs (such as a 10% global tariff and 125% on Chinese goods) could increase manufacturing costs and disrupt the supply chain, as key manufacturing processes occur in Germany[269](index=269&type=chunk)[270](index=270&type=chunk)[273](index=273&type=chunk) - The company notes that actions by activist stockholders, such as the recent proxy contest, can be disruptive, costly, and divert management's attention[352](index=352&type=chunk) - Servicing the **$265.2 million** in outstanding convertible notes requires significant cash, and conversion of the notes could dilute shareholder ownership[353](index=353&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports the completion of its $200.0 million share repurchase program as of June 30, 2025, with 6,596,048 shares repurchased during the second quarter of 2025 at an average price of $10.75 per share - The company has completed all repurchases under its authorized **$200.0 million** share repurchase program[383](index=383&type=chunk) Share Repurchases in Q2 2025 | Period | Total Shares Purchased | Average Price Paid per Share ($) | | :--- | :--- | :--- | | April 2025 | 3,342,919 | $11.36 | | May 2025 | 3,253,129 | $10.12 | | June 2025 | 0 | $0.00 | | **Total Q2** | **6,596,048** | **$10.75** |