Dynavax(US:DVAX)2021-05-05 16:00Financial 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]