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.
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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 | |
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HEPLISAV-B
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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
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$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
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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
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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
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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) |
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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 | ||||
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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 $400 million through 2024, contingent on the continued success of the program.
•
•
Phase 1/2 clinical trials initiated in December 2020
Initial safety & immunogenicity data expected in Q2 2021
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Q3 2020 Financial Metrics
($ 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
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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
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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 | |
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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