Dynavax Reports Second Quarter 2018 Financial Results
HEPLISAV-B® Launch Progressing as Planned with Key Customer Successes
Three abstracts accepted for presentation at
Conference Call to be held at
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
- 100% of
Medicare-insured lives, 94% of commercially-insured lives, and 73% of lives under state Medicaidplans are covered
- 219 of our largest targeted customers have received P&T committee approval, of whom 91 have progressed to purchase and 24 have implemented the use of HEPLISAV-B throughout their system
- Another 198 target customers have sub-committee or P&T committee review scheduled
- Q2 sales of
$1.3 millioncompared to $0.2 millionin Q1
- Encouraging SD-101 Phase 1b/2 advanced melanoma data in combination with KEYTRUDA® in patients naïve to anti PD-1 therapy for 2 mg dose selected for Phase 3:
-- Overall response rate (ORR) of 70%
-- 80% ORR in patients with low PD-L1
-- 6-month progression free survival (PFS) rate of 76%
- AEs related to SD-101 treatment were transient, mild to moderate flu-like symptoms
- End-of-Phase 2 meeting with the
U.S. Food and Drug Administration( FDA) scheduled
- Three abstracts accepted for presentation at the
European Society for Medical Oncology( ESMO) 2018 Annual Meeting, October 19-23, 2018
“The launch is progressing as planned and I continue to expect HEPLISAV-B will become the standard of care for vaccination of adults against hepatitis B. During my field visits, I have personally witnessed the strength of the product profile and label in motivating customers to switch vaccines,” said
Cash, cash equivalents and marketable securities of
Net product revenue was
Cost of sales, product was
Cost of sales, amortization of intangible assets was
Research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
Conference Call and Webcast Information
A replay of the conference call will be available for two weeks and can be accessed by dialing (844) 512-2921 in the U.S. or (412) 317-6671 internationally. The conference ID for the replay will be 2303066.
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. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.ii There is no cure for hepatitis B, but effective vaccination can prevent the disease.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.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.
For more information about HEPLISAV-B, visit http://heplisavb.com/.
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide.
This press release contains "forward-looking" statements, including statements regarding the commercialization of HEPLISAV-B, conduct of clinical trials of SD-101, including results from the Phase 1b/2 trial, planned optimal dosage for the Phase 3 trial, and potential value of SD-101 across multiple tumor types. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether we are able to continue to build the commercial infrastructure required to increase adoption of HEPLISAV-B; whether payers will provide timely reimbursement for HEPLISAV-B; whether prescribers and other key decision-makers will switch to HEPLISAV-B; whether we can timely provide adequate clinical supplies; initiation, enrollment and completion of clinical trials of SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; the ability to successfully develop and commercialize SD-101; and whether or not
KEYTRUDA is a registered trademark of
i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
ii CDC. https://www.cdc.gov/hepatitis/statistics/2015surveillance/index.htm#tabs-5-8. Fig 3.2
iii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.
iv CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.
v CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
|DYNAVAX TECHNOLOGIES CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Product revenues, net||$||1,254||$||-||$||1,419||$||-|
|Cost of sales - product||5,177||-||5,382||-|
|Cost of sales - amortization of intangible assets||2,298||-||4,715||-|
|Research and development||16,273||14,814||35,239||31,159|
|Selling, general and administrative||15,653||5,612||32,544||12,084|
|Total operating expenses||39,401||20,426||77,880||46,026|
|Loss from operations||(38,147||)||(20,321||)||(76,461||)||(45,773||)|
|Other income (expense):|
|Other income (expense), net||241||(232||)||18||(212||)|
|Basic and diluted net loss per share||$||(0.63||)||$||(0.41||)||$||(1.26||)||$||(1.00||)|
|Weighted average shares used to compute basic and diluted net loss per share||62,346||49,700||62,047||45,787|
|DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||216,043||$||191,854|
|Property and equipment, net||16,240||16,619|
|Intangible assets, net||16,364||1,306|
|Liabilities and stockholders’equity|
|Total current liabilities||$||25,522||$||18,593|
|Total long-term liabilities||107,028||643|
|Total liabilities and stockholders’ equity||$||263,863||$||218,785|
Source: Dynavax Technologies Corporation