NASDAQ: VRTX
COMPANY DESCRIPTION
Founded
in –1989 | Current Market Cap – 48.04 Billion USD
Vertex
Pharmaceuticals Incorporated is focused on the discovery, development, and
commercialization of small molecule drugs targeting serious diseases. The
company’s main area of focus is cystic fibrosis (CF). The company’s lead product
is Kalydeco (ivacaftor), which is approved for the treatment of patients with
CF who have the G551D mutation or other specified mutations in their cystic
fibrosis transmembrane conductance regulator (CFTR) gene. In 2015, Vertex
gained approval for another CF treatment, Orkambi (lumacaftor-ivacaftor
combination), for the treatment of the underlying cause of CF in patients with
two copies of the F508del mutation in their CFTR gene, also referred to as
F508del homozygous patients. Symdeko, which is a combination of tezacaftor
(VX-661) and ivacaftor (Kalydeco) gained FDA approval in February 2018 for the
treatment of patients with CF twelve years of age and older who are F508del
homozygous or who have at least one mutation that is responsive to tezacaftor/ivacaftor.
The company headquartered in Boston, Massachusetts.
RECOMMENDATION
We rate Vertex Pharma. a Sell at USD 188
for a target of USD 165 in one months.
Below are the basic reasons to
recommend this stock as a Sell.
·
Orkambi Sales Growth Dependent on Reimbursement
Approvals: Vertex has faced some challenges with respect to commercialization
of Orkambi in ex-U.S. markets due to re-imbursement hurdles. Though Vertex has
reached reimbursement agreements for Orkambi in several European countries,
including Germany, Ireland, Sweden and Italy, it is still in negotiations with
several European countries that represent significant potential markets
including the United Kingdom and France. It has recorded limited revenues of
Orkambi in these countries due to ongoing pricing discussions regarding the
reimbursement rate for Orkambi.
·
Competing Therapies in Development: The CF
market has been attracting the interest of several companies like Novartis,
Pfizer and Sanofi. These companies are pursuing the development of CFTR
potentiators, CFTR correctors and candidates with other mechanisms of action
that can address the underlying cause of CF.
·
Meanwhile, many other companies like AbbVie and
Proteostasis Therapeutics are developing triple CFTR combinations for CF, which
can pose competition to Vertex’s triple combos. Even though Vertex enjoys a
strong position in this market, the entry of additional competition would cut
into revenues.
·
Banking on CF Franchise: Although we are
positive on Vertex’s decision to focus on the CF franchise, we remain concerned
about the company’s dependence on just this franchise for growth. While the
company does have other pipeline candidates targeting other therapeutic areas,
it is too early to get excited about them.
·
Pipeline/Regulatory Setbacks: Vertex has several
studies ongoing with its CF product candidates and any negative development on
the pipeline/regulatory front would have an adverse impact on the shares. In
Aug 2016, Vertex announced that it will be stopping one of the phase III
studies being conducted on the VX-661 - ivacaftor combination following a
planned interim futility analysis. The study was being conducted in patients
with one copy of the F508del mutation and a second mutation that results in
minimal CFTR function.
·
In October 2018, Vertex discontinued development
of VX-210 (acute cervical spinal cord injuries) due to futility. In October
2017, Vertex announced that it will not file regulatory applications for VX-661
- ivacaftor combination in CF patients with one copy of the F508del mutation
and one copy of a gating mutation, as a phase III study evaluating VX-661 —
ivacaftor use in such patients failed to meet the primary endpoint.
EARNINGS
Vertex reported third-quarter 2018
earnings per share of $1.09, which beat the Consensus Estimate of $1.00.
Moreover, the figure came ahead of the year-ago earnings of 53 cents. Strong
product revenues led to higher profits in the reported quarter.
Vertex reported revenues of $784.5
million in the third quarter, surpassing Consensus Estimate of $783 million.
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