HEPLISAV-B® Barrage Avant-garde as Planned with Key Customer Successes
Three abstracts accustomed for presentation at European Society for Medical Oncology (ESMO) 2018 Annual Meeting
Conference Alarm to be captivated at 4:30pm ET/1:30pm PT
BERKELEY, Calif., Aug. 06, 2018 (GLOBE NEWSWIRE) — Dynavax Technologies Corporation (DVAX) today appear banking after-effects for the additional division concluded June 30, 2018. The net accident for the division was $39.4 million, or $0.63 per share, compared to $20.3 million, or $0.41 per share, for the division concluded June 30, 2017. Cash, banknote equivalents and bankable balance totaled $216.0 actor at June 30, 2018.
Recent HighlightsHEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]
“The barrage is avant-garde as planned and I abide to apprehend HEPLISAV-B will become the accepted of affliction for anesthetic of adults adjoin hepatitis B. During my acreage visits, I accept alone witnessed the backbone of the artefact contour and characterization in affective barter to about-face vaccines,” said Eddie Gray, arch controlling administrator of Dynavax. “Our efforts to date are alpha to pay off with accretion sales, which we apprehend will beforehand during Q4 and into 2019, back we apprehend HEPLISAV-B to be banknote abundant afore year end. In addition, we abide to beforehand our SD-101 analytic affairs which has apparent auspicious after-effects so far in both melanoma and arch and close blight patients. We attending avant-garde to afterlight these abstracts afterwards this year.”
Financial ResultsCash, banknote equivalents and bankable balance of $216.0 actor at end of the additional quarter, with $75 actor accessible from the February 2018 appellation accommodation agreement
Net artefact acquirement was $1.3 actor for the division concluded June 30, 2018, which consists of sales of HEPLISAV-B in the U.S. Artefact acquirement from sales is recorded at the net sales amount which includes estimates of artefact returns, chargebacks, discounts and added fees.
Cost of sales, artefact was $5.2 actor for the division concluded June 30, 2018 and consists of assertive fill, accomplishment and anchored aerial costs for HEPLISAV-B incurred afterwards FDA approval and costs apropos to balance accommodation at our Dusseldorf accomplishment adeptness associated with resuming operations afterwards accepting FDA approval of HEPLISAV-B and pre-filled syringes.
Cost of sales, acquittal of abstract assets was $2.3 actor for the division concluded June 30, 2018 and consists of acquittal of the abstract asset recorded as a aftereffect of anniversary and sublicense payments apropos to HEPLISAV-B.
Research and development costs for the division concluded June 30, 2018 and 2017, were $16.3 actor and $14.8 million, respectively. The admission in 2018 reflects added advantage and accompanying cadre costs accompanying to the advancing development of SD-101, DV281 and beforehand date oncology programs. Additionally, in the accepted quarter, accomplishment accompanying costs incurred by our Dusseldorf adeptness that were ahead included in analysis and development amount are now accounted for as balance accommodation in our amount of sales, product.
Selling, accepted and authoritative costs for the division concluded June 30, 2018 and 2017, were $15.7 actor and $5.6 million, respectively. The admission is primarily due to an all-embracing admission in HEPLISAV-B sales, business and bartering activities, including full-deployment of a arrangement sales force, post-marketing studies and consultants for bartering development services.
Conference Alarm and Webcast InformationDynavax will authority a appointment alarm today at 4:30pm ET/1:30pm PT. To admission the call, participants charge punch (800) 239-9838 in the U.S. or (323) 794-2551 internationally, and use the appointment ID 2303066. The alive alarm will be webcast and can be accessed in the “Investors and Media” area of the company’s website at www.dynavax.com. A epitomize of the webcast will be accessible for 30 canicule afterward the alive event.
A epitomize of the appointment alarm will be accessible for two weeks and can be accessed by dialing (844) 512-2921 in the U.S. or (412) 317-6671 internationally. The appointment ID for the epitomize will be 2303066.
About Hepatitis BHepatitis B is a viral ache of the alarmist that can become abiding and advance to cirrhosis, alarmist blight and death. The hepatitis B virus is 50 to 100 times added communicable than HIV,i and manual is on the rise. In 2015, new cases of astute hepatitis B added by added than 20 percent nationally.ii There is no cure for hepatitis B, but able anesthetic can anticipate the disease.
In adults, hepatitis B is advance through acquaintance with adulterated claret and through caught with an adulterated person. The CDC recommends anesthetic for those at aerial accident for infection due to their jobs, lifestyle, active situations and biking to assertive areas.iii Because bodies with diabetes are decidedly accessible to infection, the CDC recommends anesthetic for adults age 19 to 59 with diabetes as anon as accessible afterwards their diagnosis, and for bodies age 60 and earlier with diabetes at their physician’s discretion.iv Approximately 20 actor U.S. adults accept diabetes, and 1.5 actor new cases of diabetes are diagnosed anniversary year.v
About HEPLISAV-BHEPLISAV-B is an developed hepatitis B vaccine that combines hepatitis B apparent antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the allowed response. Dynavax has common bartering rights to HEPLISAV-B.
For added advice about HEPLISAV-B, appointment http://heplisavb.com/.
About SD-101SD-101, the Company’s advance analytic candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C chic oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several analytic studies to appraise its assurance and activity, including a Phase 2 abstraction in aggregate with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, in patients with avant-garde melanoma and in patients with arch and close squamous corpuscle cancer, in a analytic accord with Merck. Dynavax maintains all bartering rights to SD-101.
About DynavaxDynavax is a fully-integrated biopharmaceutical aggregation focused on leveraging the adeptness of the body’s congenital and adaptive allowed responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops atypical vaccines and immuno-oncology therapeutics. The Company’s aboriginal bartering product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], was accustomed by the United States Food and Drug Administration in November 2017 for blockage of infection acquired by all accepted subtypes of hepatitis B virus in adults age 18 years and older. Dynavax’s advance immunotherapy product, SD-101, is an investigational blight immunotherapeutic currently actuality evaluated in Phase 1/2 studies and its additional blight immunotherapeutic, DV281, is in Phase 1 development. For added information, appointment www.dynavax.com.
Forward-Looking Statements This columnist absolution contains “forward-looking” statements, including statements apropos the commercialization of HEPLISAV-B, conduct of analytic trials of SD-101, including after-effects from the Phase 1b/2 trial, planned optimal dosage for the Phase 3 trial, and abeyant amount of SD-101 above assorted bump types. Actual after-effects may alter materially from those set alternating in this columnist absolution due to the risks and uncertainties inherent in our business, including whether we are able to abide to body the bartering basement appropriate to admission acceptance of HEPLISAV-B; whether payers will accommodate appropriate acceding for HEPLISAV-B; whether prescribers and added key decision-makers will about-face to HEPLISAV-B; whether we can appropriate accommodate able analytic supplies; initiation, acceptance and achievement of analytic trials of SD-101; the after-effects of analytic trials and the appulse of those after-effects on the admission or assiduity of consecutive trials and issues arising in the authoritative process; the adeptness to auspiciously advance and commercialize SD-101; and whether or not Dynavax and parties with whom we are accommodating may adeptness any approaching acceding on added studies or a added all-encompassing accord above the analytic trials advised beneath the absolute agreements, as able-bodied as added risks abundant in the “Risk Factors” area of our Annual Report on Form 10-K for the budgetary year concluded December 31, 2017 and in Quarterly Report on Form 10-Q for the division concluded March 31, 2018, as able-bodied as discussions of abeyant risks, uncertainties and added important factors in our added filings with the U.S. Balance and Exchange Commission. We undertake no obligation to alter or amend advice herein to reflect contest or affairs in the future, alike if new advice becomes available. Advice on Dynavax’s website at www.dynavax.com is not congenital by advertence in our accepted alternate letters with the SEC.
KEYTRUDA is a registered brand of Merck Sharp & Dohme Corp., a accessory of Merck & Co., Inc.
Contact: David BurkeDirector, IR & Corporate Communications510.665.7269
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 3.2iii 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.
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