Docoh
Loading...

DVAX Dynavax Technologies

Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza.

Company profile

Ticker
DVAX, DVAXW
Exchange
Website
CEO
Ryan Spencer
Employees
Incorporated
Location
Fiscal year end
SEC CIK
IRS number
330728374

DVAX stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

6 May 21
4 Aug 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 79.28M 79.28M 79.28M 79.28M 79.28M 79.28M
Cash burn (monthly) (positive/no burn) (positive/no burn) (positive/no burn) 1.71M (positive/no burn) 2.28M
Cash used (since last report) n/a n/a n/a 7.08M n/a 9.43M
Cash remaining n/a n/a n/a 72.2M n/a 69.85M
Runway (months of cash) n/a n/a n/a 42.2 n/a 30.6

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
10 Jun 21 Hack Andrew A. F. Warrants Common Stock Sell Dispose S Yes No 4.5 2,916,250 13.12M 0
28 May 21 Hack Andrew A. F. Stock Option Common Stock Grant Aquire A No No 8.2 25,000 205K 25,000
28 May 21 Cano Francis Option Common Stock Grant Aquire A No No 8.2 25,000 205K 25,000
28 May 21 Eastland Julia Marie Option Common Stock Grant Aquire A No No 8.2 25,000 205K 25,000
28 May 21 Kisner Daniel L Option Common Stock Grant Aquire A No No 8.2 25,000 205K 25,000

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

73.2% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 160 142 +12.7%
Opened positions 38 11 +245.5%
Closed positions 20 34 -41.2%
Increased positions 47 53 -11.3%
Reduced positions 51 43 +18.6%
13F shares
Current Prev Q Change
Total value 1.1B 467.07M +135.1%
Total shares 83.83M 73.21M +14.5%
Total puts 1.04M 762.2K +36.7%
Total calls 2.41M 568.3K +323.8%
Total put/call ratio 0.4 1.3 -67.8%
Largest owners
Shares Value Change
FHI Federated Hermes 12.6M $123.9M +5.5%
Bain Capital Life Sciences Investors 10.9M $107.11M NEW
BLK Blackrock 8.56M $84.1M +4.5%
STT State Street 7.08M $69.63M -34.9%
Chicago Capital 5.79M $56.91M +0.1%
Vanguard 5.32M $52.31M +4.1%
Avidity Partners Management 3.5M $34.41M -12.5%
GS Goldman Sachs 3.27M $32.18M +60.9%
Partner Fund Management 2.99M $29.4M +1.8%
Blair William & Co 2.26M $22.25M +3.7%
Largest transactions
Shares Bought/sold Change
Bain Capital Life Sciences Investors 10.9M +10.9M NEW
STT State Street 7.08M -3.8M -34.9%
AMP Ameriprise Financial 32.84K -1.28M -97.5%
GS Goldman Sachs 3.27M +1.24M +60.9%
Millennium Management 831.18K +727.02K +698.0%
FHI Federated Hermes 12.6M +657.92K +5.5%
Edmond De Rothschild Holding 970K -500K -34.0%
Avidity Partners Management 3.5M -500K -12.5%
D. E. Shaw & Co. 417.54K +407.24K +3953.8%
C Citigroup 430.8K +382.82K +797.8%

Financial report summary

?
Competition
PfizerAMGENVBI VaccinesCelgeneIdera PharmaceuticalsRocheNovavaxAgenusNovartisSanofi
Risks
  • As we plan for broader commercialization of HEPLISAV-B and for expanded capacity to manufacture our CpG 1018 adjuvant, our financial commitments to increase supply capacity might outpace actual demand for our products.
  • As we continue to grow as a commercial organization and enter into supply agreements with customers, those supply agreements will have obligations to deliver product that we are reliant upon third parties to manufacture on our behalf.
  • We rely on our facility in Düsseldorf, Germany and third parties to supply materials or perform processes necessary to manufacture HEPLISAV-B and our product candidates. We rely on a limited number of suppliers to produce the oligonucleotides we require for development and commercialization. Additionally, we have limited experience in manufacturing our product candidates in commercial quantities. With respect to HEPLISAV-B, we have switched to a pre-filled syringe presentation of the vaccine and our ability to meet future demand will depend on our ability to manufacture sufficient supply in this presentation.
  • We have entered into collaborative relationships to develop vaccines utilizing our CpG 1018 adjuvant, including collaborations to develop a vaccine for COVID-19. These collaborations may not be successful. If the combination of patents, trade secrets and other proprietary rights that we rely on to protect our intellectual property rights in CpG 1018 adjuvant or otherwise are inadequate, we may be unable to realize any commercial benefit from the development of a vaccine containing CpG 1018 adjuvant.*
  • We face uncertainty regarding coverage, pricing and reimbursement and the practices of third-party payors, which may make it difficult or impossible to sell our product or product candidates on commercially reasonable terms.
  • We have applied for, and in some cases have received, grants to help fund the scale-up of CpG 1018 production, and such grants, if and when received, may involve pricing or other restrictions.
  • We implemented a strategic restructuring to prioritize our vaccine business and explore strategic alternatives for our immuno-oncology portfolio, and we cannot assure you that we will be able to successfully execute on a strategic alternative for our immuno-oncology portfolio.
  • We are subject to ongoing FDA and EMA post-marketing obligations concerning HEPLISAV-B, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with HEPLISAV-B.
  • If HEPLISAV-B or any products we develop are not accepted by the market or if regulatory agencies limit our labeling indications, require labeling content that diminishes market uptake of HEPLISAV-B or any other products we develop, or limits our marketing claims, we may be unable to generate significant revenues, if any.
  • Many of our competitors have greater financial resources and expertise than we do. If we are unable to successfully compete with existing or potential competitors as a result of these disadvantages, we may be unable to generate sufficient or any revenues and our business will be harmed.
  • We have incurred net losses in each year since our inception and anticipate that we will continue to incur significant losses for the foreseeable future unless we can successfully commercialize HEPLISAV-B and CpG 1018, and if we are unable to achieve and sustain profitability, the market value of our common stock will likely decline.
  • Until we are able to generate significant revenues or achieve profitability through product sales, we will require substantial additional capital to finance our operations.
  • Regulatory authorities may require more clinical trials for our product candidates than we currently expect or are conducting before granting regulatory approval, if regulatory approval is granted at all. Our clinical trials may be extended which may lead to substantial delays in the regulatory approval process for our product candidates and may impair our ability to generate revenues.
  • We may continue to develop, seek regulatory approval for and market HEPLISAV-B or any other product candidates we may develop outside the U.S., requiring a significant commitment of resources. Failure to successfully manage our international operations could result in significant unanticipated costs and delays in regulatory approval or commercialization of our product candidates.
  • Clinical trials for our commercial product and product candidates are expensive and time consuming, may take longer than we expect or may not be completed at all, and their outcomes are uncertain.
  • As a biopharmaceutical company, we engage clinical research organizations (“CROs”) to conduct clinical studies, and failure by us or our CROs to conduct a clinical study in accordance with GCP standards and other applicable regulatory requirements could result in disqualification of the applicable clinical trial from consideration in support of approval of a potential product.
  • HEPLISAV-B and most of our earlier stage programs rely on oligonucleotide TLR agonists. Serious adverse event data relating to TLR agonists may require us to reduce the scope of or discontinue our operations, or reevaluate the viability of strategic alternatives.
  • A key part of our business strategy for products in development is to establish collaborative relationships to help fund development and commercialization of our product candidates and research programs. We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to continue to develop and commercialize those products and programs, if at all.
  • The term loan agreement we entered into in February 2018 imposes significant operating and financial restrictions on us that may prevent us from pursuing certain business opportunities and restrict our ability to operate our business.
  • If we fail to comply with the extensive requirements applicable to biopharmaceutical manufacturers and marketers under the healthcare fraud and abuse, anticorruption, privacy, transparency and other laws of the jurisdictions in which we conduct our business, we may be subject to significant liability.
  • We face product liability exposure, which, if not covered by insurance, could result in significant financial liability.
  • If third parties successfully assert that we have infringed their patents and proprietary rights or challenge our patents and proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly, time consuming and delay or prevent development or commercialization of our product candidates.
  • Our business operations are vulnerable to interruptions by natural disasters, health epidemics and other catastrophic events beyond our control, the occurrence of which could materially harm our manufacturing, distribution, sales, business operations and financial results.
  • Significant disruptions of information technology systems or breaches of data security could adversely affect our business.
Management Discussion
  • Revenues consist of amounts earned from product sales and other revenues. Product revenue, net, includes sales of HEPLISAV-B and CpG 1018 adjuvant.
  • Revenue from HEPLISAV-B product sales is recorded at the net sales price, which includes estimates of product returns, chargebacks, discounts, rebates and other fees. We sell our CpG 1018 adjuvant to our collaboration partners for use in their development and/or commercialization of COVID-19 vaccine. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract.
  • Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
Content analysis
?
Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. junior Avg
New words: anesthesiologist, AstraZeneca, autoimmune, backend, Biden, Canada, Carlo, certified, cGMP, CHMP, clear, compensatory, compulsory, constitutionality, deviate, discovered, Dusseldorf, evidence, Extra, factor, feasible, forensic, forgivable, forgiven, GLP, harbor, harder, headwind, immunogenicity, Importantly, injunction, injunctive, inter, Internationally, IPR, Israel, Johnson, LLP, medicinal, middle, Moderna, Monte, nationwide, Northern, nurse, open, overturning, persist, PGR, pharmacovigilance, pharmacy, post, pre, preliminary, PSU, punitive, reconsider, reexamining, repay, restoration, retrospective, risky, robust, rollout, RSU, safe, sequester, shift, short, Similarly, simulation, speculative, subtracted, supplemental, Supreme, thereunder, tie, top, transmit, Undistributed, unnecessary, unsecured, viable, visibility, waiver, weakening, withdrew
Removed: accept, accommodate, achievement, acquired, adequacy, advancement, allocation, amounted, antigen, attestation, authority, authorized, biosimilar, Blueprint, borrow, borrowing, broadening, broadly, CEO, codified, complying, comprise, comprised, Consumer, Delaware, delivered, directed, Dohme, double, enrolled, exclude, expansive, expedient, expended, expired, feedback, fifteenth, firm, framework, free, generic, Helix, hourly, importance, incentivize, incorporated, incremental, installment, interference, interpret, intrinsic, irrevocable, jurisdiction, lesser, liable, lowering, MAA, Nasdaq, newly, occupancy, oncology, permitting, perpetual, pipeline, pocket, power, PPACA, practical, proposal, published, reincorporated, reliability, reproduced, respond, royalty, Sharp, Sharpe, shelter, SIIPL, sixteenth, solicited, step, successor, tranche, unallocated, uneven, uninterrupted, unqualified, unrecognized, vesting, weigh, word

Patents

APP
Utility
Combination of a PD-1 Antagonist and CPG-C Type Oligonucleotide for Treating Cancer
1 Jul 21
The present disclosure describes combination therapies comprising an antagonist of Programmed Death 1 receptor (PD-1) and a Toll-like receptor 9 (T1119) agonist that is a CpG-C type oligonucleotide, and the use of the combination therapies for the treatment of cancer.
GRANT
Utility
Combination of a PD-1 antagonist and CPG-C type oligonucleotide for treating cancer
24 Aug 20
The present disclosure describes combination therapies comprising an antagonist of Programmed Death 1 receptor (PD-1) and a Toll-like receptor 9 (TLR9) agonist that is a CpG-C type oligonucleotide, and the use of the combination therapies for the treatment of cancer.
GRANT
Utility
Cleavable conjugates of TLR7/8 agonist compounds, methods for preparation, and uses thereof
27 Jul 20
The present disclosure relates to cleavable conjugates (for example, particle-based or antibody-based conjugates) of TLR7/8 agonists (for example, 1H-imidazo[4,5-c]quinoline derivatives) containing a conjugation linker, a cleavable linker, and a self-eliminating linker.
APP
Utility
Alkyl Chain Modified Imidazoquinoline TLR7/8 Agonist Compounds and Uses Thereof
24 Jun 20
Disclosed are alkyl chain modified 1H-imidazoquinoline compounds, derivatives and analogs thereof, as Toll-like receptor-7 and -8 agonists for enhancing immune responses.
GRANT
Utility
Alkyl chain modified imidazoquinoline TLR7/8 agonist compounds and uses thereof
13 Apr 20
Disclosed are alkyl chain modified 1H-imidazoquinoline compounds, derivatives and analogs thereof, as Toll-like receptor-7 and -8 agonists for enhancing immune responses.