Dynavax Announces Fourth Quarter and Full Year 2018 Financial Results
- Fourth quarter 2018 HEPLISAV-B® net product revenue of
- Phase Ib/2 safety data for inhaled DV281 will be presented at the AACR Annual Meeting
- SD-101 demonstrates consistent and meaningful clinical benefit to anti-PD-1 therapy
- Conference call to be held today at
4:30 p.m. ET/ 1:30 p.m. PT
“I am proud of our 2018 achievements, particularly the launch of HEPLISAV-B, which enabled us to generate revenue of
Mr. Gray continued. “In immuno-oncology, we are focused on paths to approval where we believe our TLR9 technology has a competitive advantage. SD-101, in combination with pembrolizumab has consistently demonstrated response rates in melanoma and head and neck cancer that are higher than those reported for pembrolizumab alone. We are actively evaluating a number of opportunities, including partnerships, to advance SD-101 into registrational studies, and are committed to being thoughtful and diligent in determining the best path forward to drive value for our shareholders and provide better options for patients.”
2018 and Recent Business Highlights
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
• Fourth quarter 2018 sales of
• More than 1,200 individual customers purchased HEPLISAV-B in 2018
• More than 80% of doses sold to date were purchased by repeat customers
• 592 of the largest targeted customers, which represent more than 36% of the targeted doses, have received P&T committee approval; 354 have progressed to purchase
• Purchase contracts have been executed with 3 of the top 10 retail pharmacies
• Initial purchases by state and county health departments through the CDC Vaccines for Adults program began in the first quarter of 2019
SD-101 adds meaningful clinical benefit to KEYTRUDA® (pembrolizumab) therapy.
• In November, the company presented encouraging and consistent results from the Phase 1b/2 trial of SD-101 in combination with KEYTRUDA® at the
- In patients with advanced melanoma who are naïve to anti-PD-1 therapy
- 70% overall response rate (ORR) in the 2-milligram dose cohort
- Tumor shrinkage occurred in both injected target lesions and non-injected target lesions; non-injected lesions demonstrated an ORR of 68%, including visceral metastases in the lung and liver
- The ORR is identical to that reported at
ASCO2018, despite increasing the patient population by more than 50%, from 30 to 47 patients
- 85% 6-month progression-free survival (PFS) rate
- Observed responses in injected lesions and non-injected distant lesions
- Responses were independent of baseline PD-L1 expression
- In patients with melanoma refractory or resistant to anti-PD-1 therapy
- 20.7% ORR in 29 patients in the 8-milligram dose cohort
- In patients with head and neck squamous cell carcinoma who were naïve to anti-PD-1 therapy
- 27.3% ORR in 22 patients in the 8-milligram dose cohort
• Dynavax has fully enrolled the 2-milligram cohort in patients with melanoma refractory or resistant to anti-PD-1 therapy and in patients with head and neck squamous cell carcinoma who were naïve to anti-PD-1 therapy. Data from these cohorts are expected later this year.
• SD-101 and KEYTRUDA® are being evaluated in a new randomized, controlled, investigational treatment arm for the ongoing I-SPY 2 TRIAL™ for neoadjuvant treatment of locally advanced breast cancer.
• Adverse events related to SD-101 treatment have been transient, mild to moderate flu-like symptoms.
DV281 is a TLR9 agonist designed for delivery to lung cancer patients by inhalation.
• Dynavax is conducting a Phase 1b/2 clinical trial in subjects with advanced non-small cell lung cancer to investigate the safety and tolerability of DV281 as monotherapy and in combination with OPDIVO® (nivolumab) and to identify a recommended dose for the expansion part of the study.
• Studies in preclinical animal models of metastatic cancer show that direct delivery of DV281 to tumor-bearing lungs results in induction of interferons and cytokines and infiltration of T cells, responses similar to those observed after intratumoral injection of SD-101.
• Dynavax will present a poster (Abstract 8304) from the safety portion of the inhaled DV281 study at the AACR Annual Meeting. The poster titled “Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non small cell lung cancer (NSCLC)” will be presented
Product Revenue, Net. Dynavax’s first commercial product, HEPLISAV-B, was launched in the first quarter of 2018. Net product revenue for the fourth quarter of 2018 was
Cost of Sales, Product. Cost of sales, product, for the fourth quarter of 2018 was
R&D Expenses. Research and development expenses for the fourth quarter of 2018 totaled
SG&A. Selling, general and administrative expenses for the fourth quarter of 2018 totaled
Net Loss. Net loss for the fourth quarter of 2018 was
Cash Position. Cash, cash equivalents and marketable securities totaled
Conference Call and Webcast Information
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.
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in
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 and potential value of SD-101 across multiple tumor types, conduct of clinical trials of DV281, and a planned borrowing under its existing term loan agreement. 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 and DV281; 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 DV281; and whether or not
KEYTRUDA is a registered trademark of
Vice President, Investor Relations & Corporate Communications
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||Years Ended|
|December 31,||December 31,|
|Product revenue, net||$||3,932||$||-||$||6,812||$||-|
|Cost of sales - product||1,625||-||10,934||-|
|Cost of sales - amortization of intangible assets||2,324||1,194||10,862||1,194|
|Research and development||22,892||17,412||74,951||64,988|
|Selling, general and administrative||16,438||9,256||64,770||27,367|
|Total operating expenses||43,279||27,862||161,517||96,332|
|Loss from operations||(37,961||)||(27,841||)||(153,319||)||(96,005||)|
|Other income (expense):|
|Other expense, net||(145||)||(108||)||(70||)||(486||)|
|Basic and diluted net loss per share||$||(0.64||)||$||(0.45||)||$||(2.55||)||$||(1.81||)|
|Weighted average shares used to compute basic and diluted net loss per share||62,694||61,007||62,362||52,613|
|DYNAVAX TECHNOLOGIES CORPORATION|
|SELECTED BALANCE SHEET DATA|
|December 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||145,536||$||191,854|
|Property and equipment, net||17,064||16,619|
|Intangible assets, net||11,717||1,306|
|Liabilities and stockholders’ equity|
|Total current liabilities||$||38,033||$||18,593|
|Total long-term liabilities||109,786||643|
|Total liabilities and stockholders’ equity||$||210,884||$||218,785|
Source: Dynavax Technologies Corporation