UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 8, 2024, Dynavax Technologies Corporation ("Dynavax") issued a press release announcing its financial results for the first quarter ended March 31, 2024. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
The information with respect to item 2.02 in this current report and its accompanying exhibit shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this current report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. The following exhibit is furnished herewith:
99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Dynavax Technologies Corporation |
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Date: |
May 8, 2024 |
By: |
/s/ Ryan Spencer |
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Ryan Spencer |
Exhibit 99.1
Dynavax Reports First Quarter 2024 Financial Results
and Provides Business Updates
EMERYVILLE, CA – May 8, 2024 – Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results and provided a business update for the quarter ended March 31, 2024.
“The first quarter of 2024 saw continued year-over-year growth in quarterly HEPLISAV-B net product revenue. As we expected, growth in the U.S. hepatitis B vaccine market was slightly down during the first quarter compared to the fourth quarter due to an extended cough, cold and flu season which reduced the number of vaccination opportunities – a dynamic observed across other non-respiratory vaccine markets beyond hepatitis B. Despite this start to the year, we remain very encouraged about the hepatitis B market opportunity, both in 2024 and longer term. We are now seeing a pickup in the market as providers have begun to shift to non-respiratory vaccine campaigns in recent weeks, our retail pharmacy partners are expected to meet their demand expectations for this year, and several top IDN systems are planning to launch new hepatitis B focused initiatives. The U.S. adult hepatitis B vaccine opportunity remains significant with over 130 million patients eligible, one of the largest addressable patient populations in the U.S., and the vast majority remaining unvaccinated,” said Ryan Spencer, Chief Executive Officer of Dynavax.
“We’re also excited for several upcoming milestones from our novel vaccine pipeline, including the planned initiation of a mid-stage clinical trial in shingles this year, and data readouts from our plague and shingles vaccine programs expected across 2024 and 2025. In addition to this continued execution, and bolstered by our strong financial position, we continue to evaluate strategic opportunities to accelerate growth and further diversify our portfolio."
BUSINESS UPDATES
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and Great Britain that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.
Clinical Pipeline
Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018® adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.
Shingles vaccine program:
Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 years and older.
Tdap vaccine program:
Tdap-1018 is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis (Tdap).
Plague vaccine program:
Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018® currently in a Phase 2 clinical trial in collaboration with, and fully funded by, the U.S. Department of Defense.
FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS
Total Revenues and Net Product Revenue.
Cost of Sales - Product. Cost of sales - product for HEPLISAV-B the first quarter of 2024 decreased to $11.0 million, compared to $14.7 million for the first quarter of 2023. The decrease was primarily due to lower per-unit manufacturing costs as the result of previous process improvements, partially offset by a $1.3 million inventory write-off charge recorded during the first quarter of 2024.
Research and Development Expenses (R&D). R&D expenses for the first quarter of 2024 decreased to $13.5 million, compared to $13.6 million for the first quarter of 2023. The decrease was primarily driven by the timing of clinical development costs due to the completion of clinical trials in early 2023 and activities for planned clinical trials in 2024, partially offset by increases related to investments in our CpG 1018 preclinical and clinical collaborations.
Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the first quarter of 2024 increased to $44.1 million, compared to $36.5 million for the first quarter of 2023. The increase was primarily driven by increased headcount and other investments supporting our strategic growth, including an overall increase in targeted commercial and marketing efforts designed to increase HEPLISAV-B market share and maximize the opportunities presented by the ACIP's universal recommendation.
Net Loss. GAAP net loss was $8.7 million, or $0.07 per share (basic and diluted) in the first quarter of 2024, compared to GAAP net loss of $24.3 million, or $0.19 per share (basic and diluted) in the first quarter of 2023.
Cash and Marketable Securities. Cash, cash equivalents and marketable securities were $723.5 million as of March 31, 2024.
2024 FINANCIAL GUIDANCE
Dynavax is reaffirming the following full year 2024 financial guidance, based on the Company’s current operating plan:
Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on Wednesday, May 8, 2024, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/events-presentations. A replay of the webcast will be available for 30 days following the live event.
To dial into the call, participants will need to register for the call using the caller registration link at https://investors.dynavax.com/events-presentations and under the “Upcoming Events” section, click on "Listen to webcast." It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.
Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.
For full U.S. Prescribing Information for HEPLISAV-B, please visit the following website at https://www.heplisavbhcp.com, and click the “Prescribing Information” link in the “Important Safety Information” section.
Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).
About Dynavax
Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant with adjuvanted vaccine clinical programs for shingles and Tdap, and through global collaborations, currently focused on adjuvanted vaccines for COVID-19, plague, seasonal influenza and universal influenza. For more information about our marketed products and development pipeline, visit www.dynavax.com.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “will,” “may,” “plan,” “project,” “potential,” “seek,” “should,” “think,” “toward,” “will,” “would” and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding our expected financial results and market share as of and for the year ended December 31, 2024, expectations regarding future growth and market share, the timing of IND filings, initiation and completion of clinical studies, expected timing for data readouts, and interaction with regulators. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that actual demand for our products may differ from our expectations, risks relating to our ability to commercialize and supply HEPLISAV-B, risks related to the timing of completion and results of current clinical studies, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018 adjuvant, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended March 31, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes
available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
For Investors/Media:
Paul Cox
pcox@dynavax.com
510-665-0499
Nicole Arndt
narndt@dynavax.com
510-665-7264
DYNAVAX TECHNOLOGIES CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended |
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March 31, |
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2024 |
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2023 |
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Revenues: |
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Product revenues, net |
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$ |
47,845 |
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$ |
43,451 |
Other revenue |
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2,945 |
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3,474 |
Total revenues |
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50,790 |
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46,925 |
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Operating expenses: |
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Cost of sales – product |
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10,966 |
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14,712 |
Research and development |
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13,528 |
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13,605 |
Selling, general and administrative |
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44,065 |
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36,543 |
Bad debt expense |
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- |
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12,313 |
Total operating expenses |
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68,559 |
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77,173 |
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Loss from operations |
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(17,769) |
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(30,248) |
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Other income (expense): |
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Interest income |
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9,468 |
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6,597 |
Interest expense |
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(1,695) |
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(1,686) |
Sublease (expense) income |
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(1,602) |
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1,598 |
Other |
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101 |
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23 |
Net loss before income taxes |
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(11,497) |
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(23,716) |
Benefit from (provision for) income taxes |
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2,776 |
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(616) |
Net loss |
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$ |
(8,721) |
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$ |
(24,332) |
Net loss per share attributable to common |
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stockholders: |
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Basic |
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$ |
(0.07) |
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$ |
(0.19) |
Diluted |
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$ |
(0.07) |
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$ |
(0.19) |
Weighted-average shares used in computing net loss per share attributable to common stockholders: |
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Basic |
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130,200 |
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127,921 |
Diluted |
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130,200 |
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127,921 |
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
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March 31, |
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December 31, |
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2024 |
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2023 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
723,538 |
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$ |
742,302 |
Inventories |
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61,806 |
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53,290 |
Other current assets |
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65,942 |
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63,528 |
Total current assets |
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851,286 |
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859,120 |
Total non-current assets |
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135,279 |
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137,976 |
Total assets |
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$ |
986,565 |
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$ |
997,096 |
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Liabilities and stockholders’ equity |
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Total current liabilities |
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$ |
56,002 |
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$ |
62,195 |
Total long-term liabilities |
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312,083 |
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312,829 |
Stockholders’ equity |
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618,480 |
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622,072 |
Total liabilities and stockholders’ equity |
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$ |
986,565 |
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$ |
997,096 |