Dynavax Reports Fourth Quarter and Year End 2017 Financial Results
HEPLISAV-B Launched in
Phase 2 Data in Two Immuno-oncology Programs Planned for First Half 2018
FDAapproval of first and only two-dose hepatitis B vaccine, HEPLISAV-B™ [Hepatitis B Vaccine (Recombinant), Adjuvanted] for prevention of infection caused by all known subtypes of the virus in adults age 18 years and older
- Launched HEPLISAV-B in the U.S. with a 60-person field sales team covering over 75% of the target market
- HEPLISAV-B recommended by the
Centers for Disease Controland Prevention’s (CDC) Advisory Committee on Immunization Practices(ACIP) for use in the vaccination of adults, which is a critical milestone to drive broad insurance coverage and adoption for HEPLISAV-B $100 millionreceived in initial tranche of $175 millionnon-dilutive term loan agreement to support commercial efforts and advance and expand immuno-oncology platform
“On the heels of HEPLISAV-B’s
“Equally exciting are the opportunities to generate significant additional value for
The Company had
Additional Financial Results
Research and development expenses for the quarter and year ended
Selling, general and administrative expenses for the quarter and year ended
About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. Hepatitis B is a major public health issue in
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends that individuals at high risk for hepatitis B infection due to their jobs, lifestyle, living situations and travel to certain areas be immunized.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iv Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.v
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response.
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of 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%).
For full Prescribing Information for HEPLISAV-B, click here.
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide.
For information about SD-101 and DV281 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.
This press release contains forward-looking statements, including statements regarding the commercialization of HEPLISAV-B. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether the company will be able to continue building the commercial infrastructure required to successfully launch HEPLISAV-B; whether payers will provide timely reimbursement for HEPLISAV-B; whether prescribers and other key decision-makers will switch to HEPLISAV-B; whether potential claims against us, including those based on patent rights of others, will result in an injunction against sales or otherwise impact commercialization and sales; and the uncertain clinical development process, the outcome, cost and timing of our product development activities, our ability to obtain and maintain regulatory approval of our product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of
Director, IR & Corporate Communications
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
|Three Months Ended||Years Ended|
|December 31,||December 31,|
|Service and license revenue||21||-||32||884|
|Amortization of intangible assets||1,194||-||1,194||-|
|Research and development||17,412||18,442||64,988||84,493|
|Selling, general and administrative||9,256||8,171||27,367||37,257|
|Total operating expenses||27,862||26,613||96,332||121,750|
|Loss from operations||(27,841||)||(19,321||)||(96,005||)||(110,707||)|
|Other (expense) income:|
|Other (expense) income, net||(108||)||(2,560||)||(486||)||(2,492||)|
|Basic and diluted net loss per share||$||(0.45||)||$||(0.56||)||$||(1.81||)||$||(2.92||)|
|Weighted average shares used to compute
basic and diluted net loss per share
SELECTED BALANCE SHEET DATA
|December 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||191,854||$||81,415|
|Property and equipment, net||16,619||17,174|
|Liabilities and stockholders’equity|
|Total liabilities and stockholders’ equity||$||218,785||$||109,680|
Source: Dynavax Technologies Corporation