Protection for an unpredictable world®

We develop and commercialize innovative vaccines

E34`

Corporate Overview

Nasdaq: DVAX

Forward-Looking Statements

Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about HEPLISAV-B becoming the market leader and standard of care in the U.S., potential market opportunity for HEPLISAV-B in the U.S., China and other countries, the completion of post-marketing studies of HEPLISAV-B, our development of a vaccine for COVID-19, our development and commercialization of an improved pertussis vaccine and other vaccines using our novel adjuvant CpG 1018, establishing CpG 1018 as a leading adjuvant platform, and revenue potential for CpG 1018. These forward-looking statements are based upon management's current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks related to the continuing impact of COVID-19 on vaccine utilization and sales, including HEPLISAV-B; risks related to the potential adverse effects of the coronavirus pandemic on our ability to access customers and on customer decision making, adoption and implementation; risks related to Dynavax's ability to successfully commercialize HEPLISAV-B, which among other things will require Dynavax to successfully negotiate and enter into contracts with wholesalers, distributors, group purchasing organizations, and other parties, and maintain those contractual relationships, maintain and build its commercial infrastructure, and access prescribers and other key health care providers to discuss HEPLISAV-B; risks related to market adoption and competing therapies; risks related to whether payors will cover and provide timely and adequate reimbursement for HEPLISAV-B; risks related to the completion, timing of completion and results of post-marketing clinical trials of HEPLISAV-B; risks related to development and commercialization of HEPLISAV-B in Europe, China and other countries; and risks associated with the development and commercialization of vaccines in the U.S. and outside the U.S., including vaccines for COVID-19 and pertussis. These and other risks and uncertainties are described in Dynavax's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and our 10-K for the year ended December 31, 2019, under the heading "Risk Factors". Dynavax undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

2

Investment Highlights

HEPLISAV-B®

  • U.S. FDA approved, 2-dose adult hepatitis B vaccine
  • Positioned to become the standard of care for adults in U.S.
  • Addresses potential $600 million market opportunity in U.S.
  • CHMP positive opinion on HEPLISAV-B European MAA
    • Final approval expected Q1 2021

Advanced adjuvant contained in FDA approved HEPLISAV-B

CpG 1018™

Utilized in multiple vaccine approaches across varied

indications, including COVID-19, pertussis and universal flu

Valneva COVID-19 commercial supply agreement expected to

provide $130-$230 million in revenue to Dynavax in 2021

3

HEPLISAV-B

4

Hepatitis B Infection

22% to 54%

HBV is 50-100X

more

infectious

than

850k+

HIV

of patients complete

the 3-dose regimen

over the required

HBV infection rates

people in the U.S. are

6-month period

increased ~11% over a

infected with hepatitis B;

5 year period

250M+ worldwide

ATTRACTIVE

Commercial Profile

HEPLISAV-BEngerix-B®*

1 month

6-month

2-dose

3-dose

Faster & higher rates of protection and similar safety profile

ESTABLISHED

Targeted Market

Highly-experienced vaccine sales force to drive market uptake

POTENTIAL

Market Expansion

Positioned to

become standard

of care in U.S.

* Engerix-B® [Hepatitis B Vaccine (Recombinant)], is manufactured by GlaxoSmithKline, plc

5

Improved Protection with HEPLISAV-B Drives Adoption

Higher and faster rates of protection

  • HEPLISAV-Bprovided significantly higher rates of protection than Engerix-B at every time point

Protection for patients most at need

  • HEPLISAV-Bprovided significantly higher rates of protection in diabetics and other known hypo-responsive populations

Fewer doses

Favorable safety profile

HEPLISAV-B can protect with only 2 doses in 1 month

Across clinical trials in nearly 10,000 patients

% Seroprotection (anti-HBs>10 mIU/mL)

Weeks

Injections

Study 2 per ProtocolPopulation(ages 40-70)

100%

(N=1,482)

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

0

4

8

12

18

24

28

32

36

44

52

HEPLISAV-B

Engerix-B

Primary endpoint

6

$600 M Future Potential Market Opportunity in U.S.

U.S. Adult Hepatitis B Vaccine Market Opportunity Based on HEPLISAV-B Regimen and Price

Net sales

$700

$600

2019 U.S. Market

$500 $400

Dialysis

$300

Hep A/B

Combo

$200

Adult Hep B

Monovalent

$100 $0

Monovalent

Hep A/B Combo

Dialysis

Market Expansion

Based on 2019 market

Market Growth

  • Diabetes
  • Improved 2nd dose compliance
  • Increase coverage rates
  • Price increases

7

Right Commercial Strategy to Capture Opportunity

Total Adult HEPLISAV-B U.S.

Market Opportunity by Segment

Total Market by Promotional

Opportunity

Retail

Dialysis

12%

12%

DOD

8%

Public

8%

IDN

21%Other

19%

Independent

20%

Retail & National

Accounts

26%

Field

Targets

33%

Focus on high value accounts 23% market share as of Q3 2020

Dialysis*

12%

Unassigned

29%

White space and small independent locations

  • 42,000 locations with average of <30 doses per year

*Currently no promotional activity in dialysis segment

8

Commercial Execution Driving Adoption Across Segments

Total Adult HEPLISAV-B U.S.

HEPLISAV-B Doses Sold by Segment

Market Opportunity by Segment

DOD

8%

Public

8%

IDN 21%

Retail

Dialysis

12%

12%

Independent

20%

Other

Q1'19

Q2'19

Q3'19

Q4'19

Q1'20

Q2'20

Q3'20

19%

Public Health

DOD

Retail Pharmacy

*Currently no promotional activity in dialysis segment

9

Path to Capturing the Current Market and

Developing Total Peak Opportunity

SHORT TERM

LONG TERM

Become standard of care within Top 10 Retail, DoD Accession and Top 20 large/influential IDNs

Develop Dialysis dosing regimen (immunogenicity publication in Q1 2021)

Continue to increase market share in field targeted accounts

Support policy initiatives aimed at universal adult recommendation and preferential use for HEPLISAV-B

Secure EU approval and

Diabetic expansion

expansion into Europe

(1.5M patients diagnosed annually)

10

CpG-1018

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CpG 1018 - Broad Vaccine Adjuvant Platform

  • Well-definedmechanism of action
    • Targeting select immune system cells, with well-characterized effects on the immune response
    • Mimicking the immune response to naturally occurring TLR9 agonists in pathogens, resulting in potent adjuvant activity for antibody responses
    • CpG 1018 is the adjuvant in an FDA approved vaccine, HEPLISAV-B
  • CpG 1018 offers an established profile for the development of a safe and effective vaccine
    • In HEPLISAV-B, CpG 1018 drives faster and consistently higher rates of protection including the elderly and populations known to be less responsive to other vaccines
    • CpG 1018 differentially elicits a preferred Th1 polarized response driving both production of antibodies and T-cell activation
    • Desirable reactogenicity response with lower adverse events compared to other adjuvants

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CpG 1018 Collaboration Pipeline

Multiple "shots on goal" for CpG 1018 in adjuvanted vaccine product candidates

Collaborator

Indication

Development

Status

Stage

Medigen

Phase 1

Preliminary safety and immunogenicity results expected early Q1;

complete

Phase 2 clinical trial expected to start mid Q1

Clover Bio

Phase 1

Pivotal Phase 2/3 clinical trial expected to start 1H21

complete

Biological E. Limited

Phase 1/2

Phase 1/2 initiated November 2020; results expected February 2021

COVID-19

ongoing

Serum Institute of India

Phase 1/2

Phase 1/2 initiated December 2020

ongoing

Commercial supply agreement announced under which Dynavax will

Valneva SE

Phase 1/2

provide CpG 1018 to produce up to 190 million doses over a four-year

ongoing

period to support Valneva's contract with the U.K. government;

Phase 1/2 initiated December 2020; results expected early Q2 21

Serum Institute of India

TdaP

Preclinical

Completion of Phase 1-enabling animal studies and toxicology

Mount Sinai

Universal and

Preclinical

Phase 1 clinical trial expected to begin in 2021

Seasonal Flu

13

Valneva Commercial Supply Agreement

In September 2020, Dynavax and Valneva SE entered into a commercial supply agreement to provide Valneva with CpG 1018 to produce 60 to 100 million doses of vaccine in 2021.

Valneva has the option to purchase CpG 1018 to produce up to an additional 90 million doses through 2024.

  • Dynavax has the potential for 2021 CpG 1018 revenue between approximately $130 and $230 million, with a total revenue potential over $400 million through 2024, contingent on the continued success of the program.

Phase 1/2 clinical trials initiated in December 2020

Initial safety & immunogenicity data expected in Q2 2021

14

Q3 2020 Financial Metrics

($ in millions)

Q3 Revenue

$13.4

Q3 Net income

$4.4

Loss from operations

($13.8)

Cash and cash equivalents at September 30, 2020

$177.2

Cash usage

$23.5

Debt*

$180.9

*due December 2023

15

2021 Goals

  • Grow HEPLISAV-B U.S. Sales
    • Continue to increase field target market share and conversion of National Accounts
    • Release final clinical study data from post-marketing safety study
    • Support U.S. policy initiatives aimed at universal adult recommendation and preferential use for HEPLISAV-B
  • Capture HEPLISAV-Bex-U.S. Value
    • Initial EU launch of HEPLISAV-B in Germany
    • Out license HEPLISAV-B in China
  • Expand Product Opportunities
    • Deliver CpG 1018 for at least 60 million doses of Valneva coronavirus vaccine generating $130M of revenue
    • Additional commercial supply agreements for COVID-19 collaborators
    • Complete Phase 1 adjuvanted Tdap-1018 vaccine trial
    • Progress CpG 1018 collaborations for new targets

16

Investment Highlights

HEPLISAV-B®

  • U.S. FDA approved, 2-dose adult hepatitis B vaccine
  • Positioned to become the standard of care for adults in U.S.
  • Addresses potential $600 million market opportunity in U.S.
  • CHMP positive opinion on HEPLISAV-B European MAA
    • Final approval expected Q1 2021

Advanced adjuvant contained in FDA approved HEPLISAV-B

CpG 1018™

Utilized in multiple vaccine approaches across varied

indications, including COVID-19, pertussis and universal flu

Valneva COVID-19 commercial supply agreement expected to

provide $130-$230 million in revenue to Dynavax in 2021

17

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Dynavax Technologies Corporation published this content on 11 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 January 2021 17:11:00 UTC