19 February 2018
1yr Target $3.25
Payout Ratio 0.00%
1yr Cap Gain 38.88%
1yr Tot Return 38.88%
EPS (ttm) $-0.68
EPS next yr $-0.59
Forward P/E ---
EPS next 5yr 0.00%
1yr Price Support ---
Market Cap $677.41 Mil
Revenues $26.20 Mil
Earnings $-190.00 Mil
Profit Margin ---
Quick Ratio 3.30
Current Ratio 3.30
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Novavax, Inc. is a clinical-stage biotech company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants. They produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats.
The Company's vaccine candidates are genetically engineered 3D nanostructures that incorporate recombinant proteins critical to disease pathogenesis. Their product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.
Novavax is also developing immune stimulating saponin-based adjuvants through their wholly owned Swedish subsidiary Novavax AB. The lead adjuvant, Matrix-MTM, has been shown to enhance immune responses and was well-tolerated in a Phase 1/2 clinical trial for the pandemic H7N9 influenza vaccine candidate, as well as in a Phase 1 clinical trial for the EBOV vaccine candidate.
Genocea Biosciences has licensed rights to the Company's Matrix technology and has conducted Phase 2 clinical trials with its herpes simplex 2 vaccine candidate using Matrix-M.
Novavax's product pipeline includes vaccine candidates engineered to elicit differentiated immune responses with the potential to provide increased protection. Their nanoparticle technology targets antigens with conserved epitopes essential for viral function. Unlike traditional vaccines that ‘mimic’ viruses and elicit naturally occurring immune responses to them, their nanoparticles are engineered to elicit differentiated immune responses, which may be more efficacious than naturally-occurring immunity. The Company's vaccine technology has the potential to be applied broadly to a wide variety of human infectious diseases.
Respiratory Syncytial Virus
Novavax is developing a respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (RSV F Vaccine) for three susceptible target populations: infants via maternal immunization, older adults (60 years of age and older) and children six months to five years of age (pediatrics). The Company believes their RSV F Vaccine represents a multi-billion dollar revenue opportunity. Currently, there is no approved RSV vaccine available.
Repeat infection and lifelong susceptibility to RSV are common and it is currently estimated the global cost burden of RSV to be in excess of $88 billion. Despite decades of effort to develop an RSV vaccine, there are currently no licensed vaccines. Although the monoclonal antibody palivizumab (Synagis) is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease, it is not indicated for use in other populations.
Novavax made a breakthrough in developing a vaccine that targets the fusion protein, or F-protein, of the virus. The F-protein has highly conserved amino acid sequences, called antigenic sites, which they believe are ideal vaccine targets. Palivizumab, which targets one such site, antigenic site II, has demonstrated protection in five randomized clinical trials. Novavax genetically engineered a novel F-protein antigen resulting in enhanced immunogenicity by exposing these antigenic sites. The RSV F Vaccine assembles into a recombinant protein nanoparticle optimized for F-protein antigen presentation. The Company is seeking to bring the first RSV vaccine to market to combat the 64 million RSV infections that occur globally each year.
Ebola In July 2015, Novavax announced top-line data from their Phase 1 clinical trial of the Ebola GP Vaccine in ascending doses, with and without their Matrix-M adjuvant, in 230 healthy adults. Participants received either one or two intramuscular injections ranging from 6.5μg to 50μg of antigen, with or without adjuvant, or placebo. Immunogenicity was assessed at multiple time points, including days 28 and 35. These Phase 1 data demonstrated that our Ebola GP Vaccine is highly immunogenic, well-tolerated and, in conjunction with the Company's proprietary Matrix-M adjuvant, resulted in significant antigen dose-sparing. Although the adjuvanted Ebola GP Vaccine was highly immunogenic at all dose levels, the adjuvanted two-dose regimens induced Ebola anti-GP antibody geometric mean responses between 45,000 and 70,000 ELISA units, representing a 500 to 750-fold rise over baseline at day 35. In 2015, Novavax also announced successful data from two separate non-human primate challenge studies of our Ebola GP Vaccine in which, in both cases, the challenge was lethal for the control animal, whereas 100% of the immunized animals were protected.
ZIKV EnvD Vaccine Novavax initiated development of a vaccine against the Zika virus in response to the unmet global medical need for a response to this serious disease. Beginning in 2015, ZIKV spread in South, Central and North America, via mosquito-borne and sexual transmission. Although acute ZIKV infections in adults are generally either asymptomatic or associated with mild symptoms (fever, joint pains and skin rash), more serious outcomes can occur, including Guillain-Barré syndrome in adults and, microcephaly in infants of women infected during pregnancy. There is no approved vaccine against ZIKV, although a number of companies have announced vaccine development efforts. Novavax is currently conducting IND-enabling preclinical studies, including studies in non-human primates and other animal models, with the goal of initiating a Phase 1 clinical trial of our ZIKV envelope dimer nanoparticle vaccine candidate in 2017.
After many years of developing virus-like particle-based influenza vaccine candidates, the Company has identified advantages of developing nanoparticle-based seasonal influenza vaccines. In particular, influenza nanoparticles can display conserved antigenic regions, which have the potential to elicit broadly neutralizing antibodies that may offer protection against a range of drifted strains. Additionally, nanoparticles offer improved purity and manufacturability and advantages for co-formulation with other nanoparticle-based vaccines. Nanovax expects to continue to develop their nanoparticle influenza vaccine program in 2018 with an ongoing goal of generating additional proof-of-concept data.
Given the ongoing development of the Company's RSV F Vaccine and the desire to develop a combination respiratory vaccine with the potential to protect against both RSV and seasonal influenza, Novavax made the decision to shift our influenza vaccine development focus from VLP-based seasonal influenza vaccines to nanoparticle-based seasonal influenza vaccines. Early preclinical development efforts now gives the Company the confidence that such a combination vaccine is feasible.
The Company's recombinant protein nanoparticle vaccine technology is based on self-assembly of surface protein antigens from pathogenic organisms including viruses, bacteria or parasites. The conformations of these nanoparticles are similar but not identical to the natural structure of surface antigens of disease organisms, and lack the genetic material required for replication and therefore are not infectious. Potential immunological advantages of protein nanoparticles may be associated with the nanoparticle conformation and the presentation of key functional epitopes that are often immunologically hidden in the native pathogen. This leads to efficient recognition by the immune system’s antigen presenting cells that trigger robust immune responses. Recognition of the nanoparticle vaccine’s repeating protein patterns by the antigen presenting cells’ toll-like receptors to stimulate innate immunity and the high purity and lack of synthetic material adds to the potential safety of recombinant nanoparticle vaccines. Protein nanoparticle vaccine technology has expanded our early-stage vaccines in development to include both virus and non-virus disease targets. The Company's most advanced protein nanoparticle vaccine candidate is their RSV F Vaccine, which self-assembles from highly purified F-protein antigen.
Adjuvants are predominantly used to enable a vaccine to increase the amplitude of the immune response and qualitatively change it, broaden its specificity to provide protection against related microorganisms and allow for effective immunization with much lower doses of antigen. Novavax AB has developed a number of adjuvant formulations, all based on their proprietary MatrixTM technology. These adjuvant formulations possess excellent immunostimulatory features with the ability to increase and prolong the protective benefits of vaccines.
While adjuvants based on novel, poorly characterized substances have been hampered by safety concerns and limited efficacy, Matrix adjuvants stimulate strong antibody and cell-mediated immune responses. Matrix adjuvants may allow for lower antigen doses, longer-duration immune responses and carry a lower risk for allergic reactions or other adverse events. The Company's Matrix technology typically induces strong cellular activation of both Th1 and Th2 types, thereby generating all classes and subclasses of antibodies, as well as potent cellular responses, including cytotoxic T lymphocytes. The Company's Matrix-M adjuvant provides a potent adjuvant effect that has been well tolerated in clinical trials. They also believe that the strong immune response and opportunity to reduce the quantity of antigen dose can significantly reduce the production cost of our vaccines. This means that their Matrix-M adjuvant has the potential to be of significant value when there is inadequate vaccine manufacturing capacity during an emerging disease threat such as an influenza pandemic.
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My Path Forward
Like all Biotechs in their clinical stage of development there's a lot of risk involved in buying their shares. And in the case of Novavax, there really isn't much information available on future estimates of fundamentals. so there's nothing screaming "Buy" when I look at these shares. But I see there may be potential here to solve some of the world's health problems by a company that's been around for awhile and therefore will probably stay around for awhile. Therefore, I believe there's merit in taking a position near here or on any pullback.
I think there's potential for a 50% move. Or even a double from this level. There's also potential for a larger company developing medications in this area of respiratory disease to buy them out. At a price just above $2, it's pretty small change to take a chance on this company.