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Novavax – NVAX (OW, $7 PT)
2015 is shaping up as a news rich year with several key data readouts and the
potential initiation of pivotal programs
What happened in 2014: In 2014, NVAX shares rose 10% vs. the NBI +30% and
+13% for the S&P. NVAX initiated four clinical trials in 2H14, setting the stage for
an important 2015 with several data readouts expected.
2015 Outlook & Thesis: We are optimistic about the potential of NVAX’s
proprietary recombinant nanoparticle vaccine technology and believe the platform
has been validated by clinical data from several programs (RSV and H5N1/H7N9
flu). NVAX is the leader in developing a vaccine to protect against infection from
respiratory syncytial virus (RSV), the leading cause of acute respiratory infections in
infants/children and what we view as the last major infectious pediatric disease
without preventive therapy. Based on safety and immunogenicity data, we see a high
probability of success for the RSV program and believe clinical data around mid-
2015 could drive meaningful upside in shares.
More specifically, NVAX initiated three clinical trials in 2014 for its RSVF protein
vaccine program: 1) a Ph2 trial in pregnant women in their 3rd trimester began in
2H14 with safety/ immunogenicity data of mother & child expected in late 3Q15, 2)
a Ph1 trial in pediatrics began in 2H14 with safety/ immunogenicity data expected in
3Q15, 3) a relatively large Ph2 trial in elderly pts (1,600 pts) began in 2H14 with
safety/ immunogenicity/efficacy signal data anticipated in 3Q15 (importantly, this
Ph2 data could define the design of the Ph3 trial, which could begin as early as YE15
in the N. hemisphere or in 1Q16 in the S. hemisphere). On NVAX's quadrivalent
seasonal influenza vaccine program, safety/ immunogenicity Ph2 data is expected
towards the end of 1Q15. Additionally, NVAX plans to initiate a Ph1 trial in 1Q15
with safety/ immunogenicity data expected in 2Q15for its combo RSV/influenza
product. The co plans to begin a Ph1 trial in 1Q15 for its ebola GP vaccine with
matrix-M, with data expected in 2Q15.
Key 2015 Catalysts: We expect important clinical data readouts throughout 2015,
incl Ph2 data for the RSV vaccine for maternal immunization and the elderly, and
Ph1 data for the RSV vaccine in pediatrics in 3Q15. Ph2 data for the quadrivalent
seasonal influenza vaccine is expected in 1Q15, and Ph1 data for a RSV+flu
combination vaccine and an ebola vaccine are expected in 2Q15. Importantly, Ph3
studies for the RSV vaccine for maternal immunization and the elderly could
potentially begin in late 2015.
Balance Sheet: NVAX ended 3Q with $190M in cash and no debt. Given this cash
position and with BARDA funding NVAX’s influenza programs, we estimate the
company has sufficient cash to fund programs into 2016.
Valuation and Key Risks: Our YE15 price target of $7 per share is based on a
blended average of our proprietary probability-adjusted scenario analysis (50%) and
a risk-adjusted NPV model (50%). Risks to our thesis/price target include clinical
setbacks (particularly for the RSV program) and competition from other companies
looking to develop an RSV vaccine.