Dynavax Corporate Presentation

Transcription

1 Dynavax Corporate Presentation

2 Forward-Looking Statements This presentation contains forward-looking statements, including statements regarding our HEPLISAV-B TM regulatory submissions, product profile, development and commercialization plans and our financial performance and anticipated key events. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether successful development and approval of HEPLISAV-B and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays; whether our studies will be sufficient for marketing approval and can be enrolled and completed in a timely manner; the potential size and value of approved indications addressable with HEPLISAV-B and the commercial potential and term of exclusivity for HEPLISAV-B; initiation and completion of pre-clinical studies and clinical trials of our other product candidates; 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; achieving the objectives of and maintaining our collaborative and licensing agreements; our ability to execute on our commercial strategies; possible claims against us, including enjoining sales of HEPLISAV-B, based on the patent rights of others; our ability to obtain additional financing to support our planned operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. These statements represent our estimates and assumptions only as of the date of this presentation. We do not undertake any obligation to update publicly any such forwardlooking statements. Page 1

3 Dynavax Overview Leader in Toll-Like Receptor (TLR) immune modulation HEPLISAV-B advancing toward approval in US Adult hepatitis B vaccine Significantly higher protection vs. market leader Worldwide commercial rights Applying platform to commercially valuable applications Potent vaccine adjuvants for rapid protection Cancer Immunotherapy Autoimmune and Inflammatory diseases Substantial IP portfolio Partnerships to support development Page 2

4 Dynavax Business Strategy HEPLISAV-B : First commercial asset HEPLISAV-B is a late stage asset with proven results in an accessible and well defined market Invest in advancement of other programs Cancer Immunotherapy POM study 2 nd generation TLR Agonist for cancer immunotherapy and vaccines Develop TLR inhibitors for immune related diseases and cancer Drive long term growth through a combination of DVAX owned and partnered programs Build commercial capabilities for accessible indications Partnerships for more complex programs Page 3

5 HEPLISAV-B

6 HEPLISAV-B Valuable Product Approaching Approval HEPLISAV-B combines proprietary TLR 9 agonist (1018) with HBsAg to prevent hepatitis B infection in adults Path to approval in the US FDA recognizes immunogenicity of vaccine, but wants more safety data Complete enrollment of final study in 2014 to support approval Commercial Opportunity Addresses multiple areas of unmet need for adult vaccination against hepatitis B US market expected to grow to $600M Dynavax has all commercial rights Page 5

7 HEPLISAV-B Final Study for Approval in the US 5,500 HEPLISAV subjects and 2,750 Engerix-B subjects All HEPLISAV subjects to be followed for safety for 1 year after last active dose All potential autoimmune events will be adjudicated by an external panel of experts Subset analysis of immunogenicity in diabetic patients planned to support commercial opportunity Enrollment targeted to be complete by end of 2014 Last patient out by end of 2015 BLA amendment with a 6 month review, approval by end of 2016 Page 6

8 Hepatitis B Vaccination Room for Improvement Rate of protection Current vaccines provide lower rate of protection for certain segments of those at risk of infection Time to protection Current 3 dose regimen over 6 months leaves patients exposed to infection Compliance In Managed Care Organization approximately 54% of patients complete the series within 1 year from first dose 1 Compliance is lower for vaccines administered in STD clinics ~45-55% of patients receive the second dose and only ~25-40% receive the third dose in a regimen 2 1 Compliance With Multiple-Dose Vaccine Schedules Among Older Children, Adolescents, and Adults: Results From a Vaccine Safety Datalink Study. American Journal of Public Health 2009; 99(2): Page 7 2 The Adult Hepatitis Vaccine Project California, Morbidity Mortality Weekly Report 2010;59(17); Hepatitis B Vaccination Among High-Risk Adolescents and Adults San Diego, California, Morbidity Mortality Weekly Report 2010; 51(28); Hepatitis B Vaccination in Six STD Clinics in the US Committed to Integrating Viral Hepatitis Prevention Services. Public Health Rep 2007; 122: 42-47

9 % Seroprotection (anti-hbs>10 miu/ml) HEPLISAV-B Phase 3 HBV-16 in Age (N=1,872) Improved protection after only 2 doses Weeks Page 8 HEPLISAV-B Engerix-B Per Protocol Population Primary Endpoint

10 HEPLISAV-B Phase 3 HBV-10 in Age % Seroprotection (anti-hbs>10 miu/ml) Confident protection across all age groups (N=2,090) Page 9 Study HBV-10 Per Protocol Population

11 HEPLISAV-B Pooled Analysis of Hyporesponsive Populations HEPLISAV-B maintains rate of protection in hyporesponsive patients HEPLISAV-B (n=3,736) M F >30 30 (yes) (no) Engerix-B (n=1,079) M F >30 30 (yes) (no) Page 10

12 Adult Hep B Vaccine US Market Growth Drivers Price, Diabetics, Promotion Potential US Adult Hepatitis B Vaccine Opportunity Well-established existing market $270M+ Diabetics, Promotion & 2 Dose Regimen Solid pricing and favorable reimbursement Increase patient value through 2 dose regimen Focused promotion Diabetic population All commercial rights Page 11 1 IMS HEALTH Confidential and Proprietary; Source: IMS Health Incorporated, DDD, February 2012.

13 HEPLISAV-B Expand US Market in Diabetes Diabetes Vaccination Potential New Cases Diagnosed = 1.5M /year 1 Age Diagnosed Prevalence 1,2 ACIP Guidelines years 10M Strong Recommendation 60+ years 10M At physician s discretion Diabetes segment can be served by focused sales force and selective promotional programs Page 12 1 CDC. National Diabetes Fact Sheet Dynavax provided data. 3 Hepatitis B ACIP Recommendations. All Accessed October 2013.

14 Pipeline Invest in Growth Through Continued Development Clinical Programs Preclinical Phase 1 Phase 2 Phase 3 Filed HEPLISAV-B Hepatitis B Vaccine SD-101 Cancer Immunotherapy DV1179 Systemic Lupus Erythematosus AZD1419 Asthma DV230 2 nd Generation TLR Agonist Page 13

15 SD-101 Lead Compound in Cancer Immunotherapy Investigator sponsored study at Stanford Phase 1 study in relapsed lymphoma post allogeneic bone marrow transplant patients Proof of Mechanism study in indolent lymphoma patients in Q Measure overall response at site of injection and distant tumors Evaluate combination with checkpoint inhibitors SD-101 provides a complementary MOA to checkpoint inhibitors by stimulating the immune response 2 nd generation TLR Agonist in development Page 14

16 Immune Related Diseases 2 clinical programs in large indications utilizing and aligning expertise with top tier partners Fully funded development with significant milestone and royalties DV1179: TLR7/9 inhibitor for autoimmune disease POM study in Lupus to be completed in Q GSK option to license the program after POM data Up to $125M in remaining milestones plus royalties AZD1419: TLR9 agonist for Asthma Disease-modifying effects in a mouse model of atopic asthma Phase 1 study in asthma expected to complete in second half of 2015 Up to $100M of remaining milestones plus royalties and co-promote rights in US Page 15

17 Dynavax Leader in TLR Immune Modulation Potent Vaccine Adjuvants HEPLISAV-B contains proprietary adjuvant DV230 proof of mechanism with infectious agent Cancer Immunotherapy SD-101 With radiation or immunotherapy antibody TLR inhibitors in certain cancers DV230 Evaluate potential use in cancer vaccines Immune Related Diseases DV1179 in Lupus (GSK) AZD1419 in Asthma (AstraZeneca) TLR 8 inhibitors using proprietary mouse model Page 16

18 Financial Summary Key Metrics Ending Q Total Cash (1) ~$177.7M As of March 31, 2014 Basic Shares Outstanding Common shares reserved for conversion of Preferred Warrants Outstanding (wtd avg price $1.96) Stock Options (wtd avg price $2.80) Unvested Equity Awards Outstanding ~263M 43M 12.5M 20.1M 1.8M (1) Unaudited cash, cash equivalents and marketable securities at 3/31/2014 Page 17

19 Dynavax Corporate Presentation