Dynavax Reports First Quarter 2018 Financial Results
Update on Initial Progress of HEPLISAV-B® Commercial Launch
Conference Call to be Held at
HEPLISAV-B® [Hepatitis B Vaccine, Recombinant (Adjuvanted)]
- CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation of HEPLISAV-B published in Morbidity and Mortality Weekly Report (MMWR) supports payer coverage, removing a major barrier for adoption
- 100% of
Medicare-insured lives, 74% of commercially-insured lives, and 60% of lives under state Medicaidplans have HEPLISAV-B specific Current Procedural Terminology (CPT) code loaded, are referencing the correct price, and have confirmed provider claims will be reimbursed. These coverage metrics have been achieved just two weeks after the publication of the MMWR
- In first 60 days following sales force launch in late February, the field sales team met with two-thirds of targeted key accounts, representing over half of addressable market
- Data abstract for Phase 1b/2 study investigating SD-101 in combination with KEYTRUDA® in advanced melanoma selected for Poster Discussion Session at 2018
American Society of Clinical Oncology( ASCO) Annual Meeting
- Data from ongoing Phase 1b/2 study of SD-101 and KEYTRUDA combination therapy presented at the 2018
American Associationfor Cancer Research (AACR) Annual Meeting
- Meaningful response in advanced head and neck squamous cell carcinoma – overall response rate of 33% (6 out of 18) (38% among patients who received at least one scan on study)
- Well-tolerated in advanced melanoma, showed no increase in frequency of immune-related adverse events over individual monotherapies, nor evidence of a unique safety signal; 86% (6 out of 7) of initial responses naïve to anti-PD-1/L1 treatment were ongoing after a median of 18 months of follow up
$250.8 millionin cash, cash equivalents and marketable securities at end of first quarter, with $75 millionavailable from February 2018term loan agreement
- Funds commercialization of HEPLISAV-B to time of expected positive cash flow and supports further immuno-oncology clinical research
“We have made significant progress since the beginning of the year,” said
“In addition, we see substantial potential upside from our immuno-oncology programs. SD-101 has been shown to generate antitumor activity in three tumor types while being well tolerated. We have funding to continue supporting new clinical trials and advancement of SD-101 into a registrational study in 2018,” Mr. Gray concluded.
Additional Financial Results
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 8635193.
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.
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.
About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with KEYTRUDA includes patients with histologically or cytologically confirmed unresectable Stage IIIc/IV melanoma. The primary endpoints of the trial are MTD and evaluation of the safety of intratumoral SD-101 in combination with KEYTRUDA. In addition, the trial is investigating response as assessed by the investigator according to RECIST v1.1, biomarker assessments and duration of response. Patients previously treated with anti-PD-1 and other immunotherapies are included.
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. 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
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
|DYNAVAX TECHNOLOGIES CORPORATION|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three Months Ended|
|Product revenues, net||$||165||$||-|
|Cost of sales - product||205||-|
|Cost of sales - amortization of intangible assets||2,417||-|
|Research and development||18,966||16,345|
|Selling, general and administrative||16,891||6,472|
|Total operating expenses||38,479||25,600|
|Loss from operations||(38,314)||(25,452)|
|Other income (expense):|
|Other (expense) income, net||(223)||20|
|Basic and diluted net loss per share||$||(0.63)||$||(0.60)|
|Weighted average shares used to compute basic and diluted
net loss per share
|DYNAVAX TECHNOLOGIES CORPORATION|
|SELECTED BALANCE SHEET DATA|
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||250,780||$||191,854|
|Property and equipment, net||17,064||16,619|
|Intangible assets, net||18,662||1,306|
|Liabilities and stockholders’ equity|
|Total current liabilities||$||23,542||$||18,593|
|Total long-term liabilities||105,904||643|
|Total liabilities and stockholders’ equity||$||295,333||$||218,785|
Source: Dynavax Technologies Corporation