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Dynavax(DVAX) - 2021 Q2 - Earnings Call Transcript
2021-08-05 01:31
Dynavax Technologies Corporation (NASDAQ:DVAX) Q2 2021 Results Conference Call August 5, 2021 4:30 PM ET Company Participants Nicole Arndt - Senior Manager, IR Ryan Spencer - CEO Kelly MacDonald - CFO Robert Janssen - CMO Donn Casale - SVP, Commercial. Conference Call Participants Phil Nadeau - Cowen and Company Matt Phipps - William Blair Josh Schimmer - Evicore Ed White - H.C. Wainwright Operator Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Second Quarter 2021 Conference Call. A ...
Dynavax(DVAX) - 2021 Q2 - Quarterly Report
2021-08-03 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, 2021 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) - 2021 Q1 - Earnings Call Transcript
2021-05-07 03:40
Dynavax Technologies Corporation (NASDAQ:DVAX) Q1 2021 Earnings Conference Call May 6, 2021 4:30 AM ET Company Participants Nicole Arndt - Senior Manager, IR Ryan Spencer - CEO Kelly MacDonald - CFO Rob Janssen - CMO Donn Casale - SVP, Commercial. Conference Call Participants Matt Phipps - William Blair Operator Good day, ladies and gentlemen, and welcome to the Dynavax Technologies First Quarter 2021 Conference Call. As a reminder, this conference call is being recorded. At the end of the Company’s prepare ...
Dynavax(DVAX) - 2021 Q1 - Quarterly Report
2021-05-05 16:00
Financial Performance - Total revenues for the three months ended March 31, 2021, were $83.335 million, a significant increase from $10.919 million for the same period in 2020, representing a growth of approximately 663%[22] - Product revenue, net for the same period was $82.885 million, compared to $10.514 million in the prior year, indicating a year-over-year increase of about 687%[22] - The company reported a net income of $891,000 for the three months ended March 31, 2021, compared to a net loss of $12.595 million for the same period in 2020[22] - For the three months ended March 31, 2021, Dynavax reported a net income of $0.9 million, a significant improvement compared to a net loss of $12.6 million for the same period in 2020[39] - Net cash provided by operating activities was $38.0 million for the three months ended March 31, 2021, compared to a net cash used of $26.9 million in the same period of 2020[31] - Selling, general and administrative expenses totaled $22,423,000 for the three months ended March 31, 2021, representing a 7% increase from $20,926,000 in the same period of 2020[173] Assets and Liabilities - Total current assets increased to $427.533 million as of March 31, 2021, up from $290.015 million at December 31, 2020, reflecting a growth of approximately 47.5%[19] - Total liabilities increased to $390.357 million as of March 31, 2021, compared to $294.579 million at December 31, 2020, marking an increase of about 32.5%[19] - The company’s accumulated deficit decreased slightly to $1.293 billion as of March 31, 2021, from $1.294 billion at December 31, 2020[19] - Cash and cash equivalents, along with marketable securities available-for-sale, totaled $79.055 million as of March 31, 2021, compared to $32.073 million at December 31, 2020, representing an increase of approximately 146%[19] - The company had cash, cash equivalents, and marketable securities totaling $232.7 million as of March 31, 2021[38] - Total cash, cash equivalents, and marketable securities amounted to $232,674,000 as of March 31, 2021, an increase from $165,036,000 on December 31, 2020, representing a growth of 41%[76] Research and Development - Research and development expenses for the three months ended March 31, 2021, were $7.758 million, up from $4.653 million in the same period of 2020, reflecting a year-over-year increase of about 66%[22] - The company expects to continue incurring substantial expenses as it invests in the commercialization of HEPLISAV-B and the development of its adjuvant[39] - Manufacturing costs incurred prior to regulatory approval are expensed as research and development costs[59] Revenue Recognition - Product revenue from CpG 1018 adjuvant sales is recognized under ASC 606 when control is transferred to customers[54] - Collaboration and manufacturing service revenue is recorded in other revenue, with revenue allocated to each performance obligation at contract inception[56] - In the first quarter of 2021, the company recognized CpG 1018 product revenue of $64.9 million, with $14.2 million reported as deferred revenue as of December 31, 2020[100] Customer Concentration and Risks - For the three months ended March 31, 2021, one customer represented approximately 87% of CpG 1018 product revenue, indicating significant customer concentration risk[109] - The ongoing COVID-19 pandemic has significantly impacted adult vaccine utilization, affecting sales of HEPLISAV-B[151] - The pandemic has caused disruptions in business operations, affecting the ability to conduct sales and marketing activities effectively[210] - The company faces risks related to maintaining a consistent supply of HEPLISAV-B due to potential impacts from COVID-19 restrictions on manufacturing facilities[214] Financing Activities - Proceeds from the issuance of common stock, net, amounted to $28.2 million for the three months ended March 31, 2021[31] - The company completed a public offering of 16,100,000 shares at a price of $5.00 per share, resulting in net proceeds of approximately $75.4 million[123] - Net cash provided by financing activities was $32.3 million for the three months ended March 31, 2021, compared to $14.5 million in the same period of 2020[184] Agreements and Collaborations - The company entered into an agreement with CEPI in January 2021 for the manufacture and reservation of CpG 1018 Materials, allowing for potential sales to third parties if not purchased by CEPI partners[94] - CEPI has agreed to provide advance payments of up to $99.0 million in the form of an interest-free, unsecured, forgivable loan for reserving CpG 1018 Materials[95] - The company entered into an agreement with CEPI for the manufacture and reservation of CpG 1018, with advance payments of up to $99 million, and an amendment for an additional $77.4 million[147][148] Stockholder Equity - The company’s total stockholders' equity increased to $99.762 million as of March 31, 2021, from $58.693 million at December 31, 2020, indicating a growth of approximately 69.9%[19] - The weighted average common stock outstanding was 112,035,000 shares, with diluted shares increasing to 113,469,000 due to stock-based compensation plans[114] Market Conditions and Competition - HEPLISAV-B has been launched in the U.S. and approved in the EU, but the company faces significant competition and unpredictable uptake and distribution efforts[199] - The company must recruit and retain effective sales personnel and maintain relationships with healthcare providers to successfully commercialize HEPLISAV-B[202] - The COVID-19 pandemic has led to reduced utilization of adult vaccines, including HEPLISAV-B, significantly impacting sales since March 2020[211]
Dynavax(DVAX) - 2020 Q4 - Earnings Call Transcript
2021-02-26 00:19
Financial Data and Key Metrics Changes - Total revenues for Q4 2020 were $19.6 million, including $13.1 million of net product revenue, with HEPLISAV-B net product revenue at $11.5 million, up from $10.6 million in Q4 2019, representing an increase of approximately 8.5% year-over-year [10][39] - Full-year HEPLISAV-B net product revenue increased from $34.6 million in 2019 to $36 million in 2020, the highest annual revenue since launch [40] - Loss from operations for Q4 2020 decreased to $11.9 million from $27.4 million in Q4 2019, and full-year 2020 loss from operations decreased to $68.4 million from $134.8 million in 2019 [48] Business Line Data and Key Metrics Changes - HEPLISAV-B experienced a strong fourth quarter with net product revenue of $11.5 million, despite a 35% reduction in overall Hepatitis B vaccine utilization [10][39] - The market share for HEPLISAV-B increased to 26% in Q1 2020, up from 20% in Q4 2019, indicating continued ability to capture market share despite disruptions [11] - CpG 1018 product revenues for 2020 were $3.3 million, with expectations for significant revenue growth in 2021 due to commercial supply agreements [41][42] Market Data and Key Metrics Changes - Market data indicated reduced non-COVID vaccine utilization in January and early February 2021 compared to Q4 2020, with expectations for HEPLISAV-B revenues to decrease in Q1 2021 [15][41] - The CDC's recommendation for COVID-19 vaccines to be administered alone is expected to impact adult vaccine utilization throughout the first half of 2021, with a return to near pre-pandemic levels anticipated in the second half [16][41] Company Strategy and Development Direction - The company aims to capture additional market share and make significant progress in national accounts, with a focus on HEPLISAV-B becoming the standard of care for adult Hepatitis B vaccination in the U.S. [13][20] - The European Commission granted marketing authorization for HEPLISAV-B, with plans to launch in Germany in Q4 2021, indicating expansion into new markets [18] - The company is also focusing on the growth of its CpG 1018 adjuvant supply business, which is expected to generate significant revenue from collaborations for COVID-19 vaccines [21][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for HEPLISAV-B to capture market share and drive revenue growth, particularly in the second half of 2021 as the backlog of patients requiring non-COVID vaccines is addressed [17][49] - The company anticipates that a universal recommendation for adult Hepatitis B vaccination could significantly expand the addressable market in the U.S. [20][49] - Management highlighted the importance of continued investment in manufacturing capabilities to meet potential demand driven by ACIP recommendations [56] Other Important Information - The company reported cash, cash equivalents, and marketable securities totaling $165 million as of December 31, 2020, providing a strong financial position for future growth [48] - The company is preparing for multiple important milestones in 2021, including potential ACIP decisions and data readouts from COVID-19 vaccine collaborations [49][80] Q&A Session Summary Question: Clarification on CpG 1018 revenues and CEPI agreements - The CEO confirmed that 40% of the supply is planned for the first half of the year, specifically regarding the Valneva collaboration, and revenue recognition occurs upon delivery to CEPI grantees [51][52] Question: Universal recommendation for Hepatitis B vaccination - Management indicated that preparations for manufacturing have been ongoing, and they are confident in their ability to meet demand following a positive ACIP vote [54][56] Question: Market penetration and recovery expectations - Management expressed confidence in market recovery tied to the completion of mass vaccination campaigns, with pent-up demand expected to drive growth in the second half of the year [62][63] Question: Hemodialysis market opportunity - The CEO noted that the hemodialysis market is concentrated among a few national providers, which simplifies targeting and engagement for potential sales [66] Question: Update on universal flu vaccine development - The company is progressing with the universal flu vaccine program, with initial clinical trials targeted for next year [69]
Dynavax(DVAX) - 2020 Q3 - Earnings Call Transcript
2020-11-05 23:19
Financial Data and Key Metrics Changes - Total product revenue for Q3 2020 was $13.3 million, with HEPLISAV-B product revenue increasing to $11.6 million from $10.2 million in Q3 2019, primarily due to a return of adult hepatitis B vaccine utilization to approximately 75% of pre-COVID levels [26][27] - Loss from operations decreased to $13.8 million from $30.6 million in the same quarter last year, while net income for Q3 was $4.4 million, mainly due to a gain of $21.2 million in the fair value of warranty liability [35] - Cash, cash equivalents, and marketable securities totaled $177.2 million as of September 30, 2020 [35] Business Line Data and Key Metrics Changes - HEPLISAV-B achieved its highest quarterly revenue since launch with net product revenue of $11.6 million, driven by significant demand from the Department of Defense and a major national retailer stocking the product [13][26] - CpG 1018 generated $1.7 million in product revenue for Q3 2020, marking the initiation of revenue from this second product [29] Market Data and Key Metrics Changes - The total adult hepatitis B market experienced a 25% reduction in utilization compared to the same period last year due to COVID-19, with the Department of Defense segment increasing by 16% [12] - Integrated delivery networks, hospital systems, and clinics saw a decrease in utilization of approximately 35% from the same period last year [12] Company Strategy and Development Direction - The company is focused on advancing HEPLISAV-B and leveraging CpG 1018 for collaborations in COVID-19 vaccine development, positioning itself for both short-term and long-term growth [6][7] - The strategy includes establishing a portfolio of collaborations to demonstrate CpG 1018's capability to enhance immune responses across various vaccine antigens [17][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of HEPLISAV-B and the potential for CpG 1018, with expectations of generating approximately $130 million to $230 million in revenue from a supply agreement with Valneva in 2021 [38] - The ongoing pandemic has highlighted the importance of vaccines, and the company aims to capitalize on this awareness to drive sales and market share growth [41] Other Important Information - The company amended its loan agreement to include sales of CpG 1018 for determining annual net sales requirements, recognizing the potential revenue opportunity from this product [30] - Cost of sales for Q3 increased to $4 million, reflecting higher unit costs for HEPLISAV-B and costs associated with producing CpG 1018 [31] Q&A Session Summary Question: What is the company's strategy regarding vaccine development? - The company aims to develop and commercialize novel vaccines, focusing on solutions for individuals with weakened immune responses, such as the elderly and those with chronic conditions [40] Question: What is the expected market opportunity for HEPLISAV-B? - The company believes HEPLISAV-B will become the standard of care for adult hepatitis B vaccination in the U.S., with a potential future market opportunity exceeding $600 million in net sales [41]
Dynavax(DVAX) - 2020 Q3 - Quarterly Report
2020-11-05 21:16
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 September 30, 2020 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 ...
Dynavax(DVAX) - 2020 Q2 - Quarterly Report
2020-08-06 20:10
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, 2020 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) - 2020 Q1 - Quarterly Report
2020-05-07 21:16
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 March 31, 2020 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 o ...
Dynavax(DVAX) - 2019 Q4 - Annual Report
2020-03-11 20:22
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, 2019 ☐ 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 other juris ...