DVAX Dynavax Technologies Corp

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 06, 2024

 

 

Dynavax Technologies Corporation

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-34207	33-0728374
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
2100 Powell Street, Suite 720
Emeryville, California				94608
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 510 848-5100

 

(Former Name or Former Address, if Changed Since Last Report)

 

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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		DVAX		Nasdaq Global Select Market

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On August 6, 2024, Dynavax Technologies Corporation ("Dynavax") issued a press release announcing its financial results for the quarter ended June 30, 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	Press release dated August 6, 2024 titled "Dynavax Reports Second Quarter 2024 Financial Results and Provides Business Updates".
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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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.

			Dynavax Technologies Corporation
Date:	August 6, 2024	By:	/s/ Kelly MacDonald
			Kelly MacDonald Senior Vice President, CFO

 

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Exhibit 99.1

Dynavax Reports Second Quarter 2024 Financial Results and Provides Business Updates

 

 

EMERYVILLE, CA – August 6, 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 June 30, 2024.

 

“We continue to strengthen our leadership position in the U.S. adult hepatitis B vaccine market with another record quarter for HEPLISAV-B, providing confidence in our current year expectations and reaffirming our long-term view of the product opportunity. We are highly optimistic about the adult hepatitis B vaccine market of over 130 million eligible patients, which is one of the largest addressable patient populations for vaccines in the U.S. We expect the market opportunity for HEPLISAV-B to grow to over $800 million by 2027, and continue expanding through the end of the decade. The expected growth in the market opportunity, combined with our expectations to continue to increase market share, provides a substantial, long-term revenue opportunity for HEPLISAV-B,” said Ryan Spencer, Chief Executive Officer of Dynavax.

 

“For our pipeline development, we are pleased to have recently initiated our Phase 1/2 trial for our novel shingles vaccine program, and remain excited for several upcoming milestones, including data readouts from the shingles study as well as our Tdap and plague vaccine programs expected across 2024 and 2025. In addition to this progress, and bolstered by our strong financial position, we continue to evaluate strategic opportunities to accelerate growth, further diversify our portfolio, and deliver value to our shareholders.”

 

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.

 

 

 

 

 

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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.

 

HEPLISAV-B for Adults on Hemodialysis

Dynavax is developing a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis.

 

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.

 

SECOND QUARTER 2024 FINANCIAL HIGHLIGHTS

 

Total Revenues and Net Product Revenue.

 

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Cost of Sales - Product. Cost of sales - product for HEPLISAV-B in the second quarter of 2024 decreased to $12.0 million, compared to $13.5 million for the second quarter of 2023. The decrease was primarily due to lower per-unit manufacturing costs as the result of previous process improvements.

Research and Development Expenses (R&D). R&D expenses for the second quarter of 2024 increased to $15.0 million, compared to $13.0 million for the second quarter of 2023. The increase was primarily driven by investments in our discovery, preclinical and clinical pipeline efforts.

Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the second quarter of 2024 increased to $41.7 million, compared to $37.1 million for the second quarter of 2023. The increase was primarily driven by increased headcount and other investments supporting our strategic growth.

Net Income. Net income was $11.4 million, or $0.09 per share basic and $0.08 diluted in the second quarter of 2024, compared to net income of $3.4 million, or $0.03 per share (basic and diluted) in the second quarter of 2023.

 

Cash and Marketable Securities. Cash, cash equivalents and marketable securities were $735.6 million as of June 30, 2024, compared to $742.3 million as of December 31, 2023.

 

2024 FINANCIAL GUIDANCE

 

Dynavax is reiterating its 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 Tuesday, August 6, 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)

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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 as a premier vaccine adjuvant used in clinical programs for shingles and Tdap, and in 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 our future growth, extent and timing of market growth and market share beyond 2024, 2027 and 2030, 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 June 30, 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

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510-665-0499

 

Nicole Arndt

narndt@dynavax.com

510-665-7264

 

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DYNAVAX TECHNOLOGIES CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

	Three Months Ended							Six Months Ended
	June 30,							June 30,
	2024				2023			2024				2023
Revenues:
Product revenue, net	$	70,188			$	56,440		$	118,032			$	99,891
Other revenue		3,607				3,809			6,552				7,283
Total revenues		73,795				60,249			124,584				107,174
Operating expenses:
Cost of sales – product		11,985				13,537			22,952				28,249
Research and development		14,950				13,046			28,478				26,651
Selling, general and administrative		41,662				37,071			85,727				73,614
Bad debt expense		-				-			-				12,313
Total operating expenses		68,597				63,654			137,157				140,827
Income (loss) from operations	5,198					(3,405)		(12,573)				(33,653)
Other income (expense):
Interest income		9,201				7,378			18,668				13,975
Interest expense		(1,698)				(1,688)			(3,393)				(3,374)
Sublease income		2,205				1,993			603				3,591
Other		-				(71)			103				(48)
Net income (loss) before income taxes		14,906				4,207			3,408			(19,509)
Provision for income taxes		(3,520)				(776)			(743)				(1,392)
Net income (loss)	$	11,386			$	3,431		$	2,665			$ (20,901)
Net income (loss) per share attributable to common stockholders:
Basic	$	0.09			$	0.03		$	0.02			$	(0.16)
Diluted	$	0.08			$	0.03		$	0.02			$	(0.16)
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders:
Basic		130,916				128,625			130,551				128,275
Diluted		154,468				152,142			133,582				128,275

 

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DYNAVAX TECHNOLOGIES CORPORATION

SELECTED BALANCE SHEET DATA

(In thousands)

(Unaudited)

 

		June 30,			December 31,
		2024			2023
Assets
Cash, cash equivalents and marketable securities		$	735,612		$	742,302
Inventories			62,462			53,290
Other current assets			83,938			63,528
Total current assets			882,012			859,120
Total non-current assets			134,309			137,976
Total assets		$	1,016,321		$	997,096
Liabilities and stockholders’ equity
Total current liabilities		$	62,192		$	62,195
Total long-term liabilities			311,280			312,829
Stockholders’ equity			642,849			622,072
Total liabilities and stockholders’ equity		$	1,016,321		$	997,096

 

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v3.24.2.u1

Document And Entity Information	Aug. 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 06, 2024
Entity Registrant Name	Dynavax Technologies Corporation
Entity Central Index Key	0001029142
Entity Emerging Growth Company	false
Entity File Number	001-34207
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	33-0728374
Entity Address, Address Line One	2100 Powell Street, Suite 720
Entity Address, City or Town	Emeryville
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94608
City Area Code	510
Local Phone Number	848-5100
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	DVAX
Security Exchange Name	NASDAQ

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