-Approximately 25,000 people with cystic
fibrosis worldwide currently eligible for treatment with ORKAMBI®
(lumacaftor/ivacaftor) or KALYDECO® (ivacaftor); Vertex advancing
the development of multiple medicines with the goal of treating all
people with cystic fibrosis-
-Fourth quarter 2015 net product revenues of
approximately $180 million for KALYDECO and $220 million for
ORKAMBI; total 2015 net CF product revenues of approximately $980
million, an increase of more than 110% versus 2014-
-Vertex provides 2016 financial guidance for
KALYDECO net product revenues of $670 to $690 million and for
non-GAAP operating expenses, excluding costs of revenues, of $1.18
to $1.23 billion-
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today outlined
key 2016 business priorities to support the company’s efforts to
discover and develop medicines for people with cystic fibrosis (CF)
and other serious diseases. Approximately 25,000 people worldwide
are currently eligible for one of Vertex’s two approved medicines
for CF, and Vertex today provided an update on its plans to develop
new medicines that have the potential to treat all people with CF.
These updates were made in advance of the 34th Annual J.P. Morgan
Healthcare Conference that begins tomorrow in San Francisco.
Vertex's Chairman, President and Chief Executive Officer, Jeffrey
Leiden, M.D., Ph.D., will discuss the company's 2016 priorities as
part of a live presentation on Monday, January 11 at 9:30 a.m. PT
(12:30 p.m. ET). The presentation will be webcast on Vertex's
website, www.vrtx.com.
Vertex also today provided preliminary financial results for
2015 and a financial outlook for 2016. Vertex expects to report
total 2015 net product revenues of approximately $980 million,
including fourth quarter 2015 net product revenues of approximately
$180 million for KALYDECO® (ivacaftor) and approximately $220
million for ORKAMBI® (lumacaftor/ivacaftor). As of December
31, 2015 more than 4,500 people had begun treatment with ORKAMBI in
the U.S. Vertex also today provided 2016 net product revenue
guidance of $670 to $690 million for KALYDECO and guidance of $1.18
to $1.23 billion for non-GAAP operating expenses, excluding costs
of revenues. The company expects to provide net product revenue
guidance for ORKAMBI during 2016 after gaining additional
information on the launch of ORKAMBI in the U.S.
“As we enter 2016, Vertex is a company with the scientific
expertise and the financial strength to consistently discover and
develop transformational medicines for people with cystic fibrosis
and other serious diseases,” said Dr. Leiden. “With the approvals
of ORKAMBI in 2015, the continued expansion in the number of people
eligible for KALYDECO and the advancement of our CF pipeline, we’ve
made tremendous progress toward our goal of developing new
medicines for all people with cystic fibrosis.”
Approved Medicines for Cystic
Fibrosis
With the approval of ORKAMBI in the U.S. and Europe, and
continued expansion in the number of people eligible for treatment
with KALYDECO, approximately 25,000 people are now eligible for
KALYDECO or ORKAMBI to treat the cause of their CF. The table below
provides an estimate of the eligible patient population for
KALYDECO and ORKAMBI:
ApproximateNumber
CFPatientsEligible
forTreatment*
Year-End 2011
2012 – 2013
Year-End 2014
Year-End 2015
KALYDECO
0
2,200
3,100
4,000
ORKAMBI
0
0
0
20,500
*Reflects the estimated number of people with CF in North America,
Europe and Australia within the approved indications for KALYDECO
or ORKAMBI.
Vertex today provided the following updates for KALYDECO,
ORKAMBI and the company’s efforts to develop new medicines with the
goal of treating all people with CF:
ORKAMBI – Approximately 20,500 people in the U.S. and Europe
Eligible for Treatment
In 2015, Vertex received regulatory approval for ORKAMBI for the
treatment of people with CF aged 12 and older with two copies of
the F508del mutation in the U.S. and European Union, where together
there are approximately 20,500 people who are eligible for
treatment with ORKAMBI. Following the approval in the European
Union in November 2015, Vertex has now begun the country-by-country
reimbursement approval process.
Ongoing Phase 3 Studies in Children Ages 6 to 11: Vertex
is currently conducting two Phase 3 clinical studies of
lumacaftor/ivacaftor in children 6 to 11 years of age to support
potential approval in children as young as six years of age. The
first study is evaluating lumacaftor/ivacaftor in approximately 50
children to support the potential FDA approval in children ages 6
to 11. The primary endpoint of this six-month study is safety.
Vertex plans to submit an sNDA to the FDA in the first half of
2016, pending data from this study. There are approximately 2,400
children ages 6-11 who have two copies of the F508del mutation in
the U.S. To support approval in the European Union, a six-month
Phase 3 efficacy study is ongoing to evaluate lumacaftor/ivacaftor
in approximately 200 children. The primary endpoint of the second
study is the absolute change in lung clearance index. There are
approximately 3,400 children ages 6-11 who have two copies of the
F508del mutation in the European Union.
KALYDECO – Continued label-expansion efforts to increase the
number of people eligible for treatment
Supplemental New Drug Application in Residual Function
Mutations: On October 7, Vertex announced that a supplemental
New Drug Application for the use of KALYDECO in people ages two and
older with one of 23 residual function mutations was accepted for
review by the FDA. The FDA granted Vertex's request for Priority
Review of this sNDA, and a target review date of February 7, 2016
was set under the Prescription Drug User Fee Act (PDUFA) for the
FDA's decision on the sNDA. More than 1,500 people with CF in the
U.S. have the mutations represented in the sNDA.
Study in Children Less Than Two Years of Age: As
CF-related complications can emerge early in life, Vertex is
preparing to initiate a clinical study of KALYDECO in children less
than two years of age to evaluate the effect of KALYDECO on markers
of CF disease in young children. The study will utilize a
weight-based dose of KALYDECO granules that can be mixed in soft
foods or liquids. The study is expected to begin in the first
quarter of 2016 and will enroll infants with one of the 10
mutations for which KALYDECO is currently approved.
Pipeline of Investigational Medicines
for CF
VX-661 – Broad Phase 3 program ongoing in multiple groups of
people with CF
Four Phase 3 studies of the investigational combination of
VX-661 and ivacaftor are ongoing in multiple different groups of
people with CF who have at least one copy of the F508del mutation.
These studies are enrolling people with CF with the following
mutations:
- Two Copies of the F508del Mutation
- One Copy of the F508del Mutation and a
Second Mutation that Results in a Gating Defect in the Cystic
Fibrosis Transmembrane Conductance Regulator (CFTR) Protein
- One Copy of the F508del Mutation and a
Second Mutation that Results in Residual CFTR Function
- One Copy of the F508del Mutation and A
Second Mutation that Results in Minimal CFTR Function
The study in people with two copies of the F508del mutation is
expected to complete enrollment in mid-2016, and data from this
six-month study are expected by early 2017. Part A of the study in
people with a mutation that results in minimal CFTR function is
expected to complete enrollment in mid-2016, and an interim
futility analysis of efficacy data from Part A of the study is
expected to be completed by the end of 2016. The two studies in
people with gating or residual function mutations are expected to
complete enrollment by the end of 2016, and data from these studies
are expected in the first half of 2017.
In addition to evaluating the efficacy of the combination
regimen, these four Phase 3 studies will also provide safety data
on the combination of VX-661 and ivacaftor to support the planned
development of a triple combination regimen that includes a
next-generation corrector in combination with VX-661 and
ivacaftor.
VX-371 – Potential for ENaC inhibitor to amplify effect of
CFTR modulation and provide benefit to other groups of people with
CF
Vertex is collaborating with Parion Sciences to develop the
investigational epithelial sodium channel (ENaC) inhibitor VX-371
as a potential treatment for all people with CF, regardless of CFTR
mutation. Parion is currently conducting an exploratory Phase 2a
study (known as the CLEAN-CF study) of inhaled VX-371 (P-1037) in
approximately 120 people with CF. The study is enrolling people
with a confirmed diagnosis of CF and any CFTR mutation. The primary
endpoint of the study is safety, and results are expected in
mid-2016. Additionally, Vertex plans to conduct a
placebo-controlled Phase 2a study to evaluate VX-371 in patients
taking lumacaftor/ivacaftor, both with and without the addition of
hypertonic saline, who have two copies of the F508del mutation.
This Phase 2a study is expected to begin in the first quarter of
2016.
Preclinical evaluation in human bronchial epithelial (HBE) cells
from people with CF who have two copies of the F508del mutation
showed that the addition of investigational VX-371 to
lumacaftor/ivacaftor resulted in an additional increase in both
airway surface liquid and cilia beat frequency compared to baseline
and to the use of VX-371 or lumacaftor/ivacaftor alone.
Improvements in airway surface liquid height and cilia beat
frequency are measures of increased hydration of the cell
surface.
Next-Generation Correctors –Triple combination studies
planned for second half of 2016
Vertex recently began clinical development of two
next-generation correctors known as VX-152 and VX-440. Both VX-152
and VX-440 are being evaluated alone and as part of a triple
combination with VX-661 and ivacaftor in ongoing Phase 1 studies in
healthy volunteers. These studies are evaluating escalating doses
of VX-152 and VX-440 for up to 14 days in duration. Pending results
of these studies, Vertex plans to initiate Phase 2 studies in
people with CF to evaluate VX-440 or VX-152 in combination with
VX-661/ivacaftor in the second half of 2016. The Phase 2 studies of
a triple combination (VX-152/VX-661/ivacaftor and
VX-440/VX-661/ivacaftor) are expected to enroll three groups of
people with CF with the following mutations:
- Two Copies of the F508del Mutation
- One Copy of the F508del Mutation and a
Second Mutation that Results in Minimal CFTR Function
- One Copy of the F508del Mutation and a
Second Mutation that is Known to be Responsive to ivacaftor
The Phase 2 studies are expected to be 28 days in duration.
CRISPR Collaboration – Gene editing collaboration focused on
discovering treatments to address the mutations and genes known to
cause and contribute to CF
In October 2015, Vertex announced that it had entered into a
strategic research collaboration with CRISPR Therapeutics focused
on the use of CRISPR's gene editing technology, known as
CRISPR-Cas9, to discover and develop potential new treatments aimed
at the underlying genetic causes of human disease. The
collaboration will evaluate the use of CRISPR-Cas9 across multiple
diseases where targets have been validated through human genetics.
As part of the collaboration, Vertex and CRISPR will evaluate the
use of CRISPR-Cas9 to potentially correct the mutations in the CFTR
gene known to result in the defective protein that causes CF and to
edit other genes that contribute to the disease.
Research and Development
Programs
Beyond CF, Vertex is advancing multiple research and development
programs focused on the treatment of key mechanisms in multiple
serious diseases. The company today provided the following updates
to its pipeline programs:
Oncology – Three investigational medicines designed to
inhibit DNA repair pathways
Vertex has three investigational medicines in early development
that are designed to inhibit DNA repair pathways that are
fundamental to the survival and proliferation of certain cancers.
These investigational medicines, which were discovered by Vertex
scientists, may be applicable to the treatment of multiple tumor
types.
- VX-970: Multiple Ongoing and
Planned Studies in People with Solid Tumors: VX-970 is Vertex's
most advanced drug candidate in oncology. By inhibiting a protein
kinase known as ATR, VX-970 targets a critical regulator of the DNA
damage repair system. Cancer cells often have defects in the DNA
damage repair system that contribute to disease progression and
drive reliance on ATR for survival from DNA damage. Inhibition of
ATR may therefore selectively kill cancer cells under DNA damaging
conditions.
Vertex's strategy is to evaluate VX-970 in early-stage trials in
selected tumor types and patient subtypes that are expected to be
responsive to ATR inhibition based on biomarker data. These studies
will be used to generate data that will inform potential late-stage
clinical development. Vertex expects VX-970 to be evaluated as
monotherapy and in combination with other cancer therapies,
including PARP inhibitors and other targeted agents, chemotherapy,
radiotherapy and immuno-oncology therapies. Vertex is currently
conducting two Phase 1/2 studies that are enrolling specific
cohorts of triple-negative breast cancer patients and non-small
cell lung cancer patients. In these studies, VX-970 is being dosed
in combination with commonly used DNA-damaging therapies. Vertex
anticipates that preliminary clinical data from these studies will
be available for presentation at medical meetings in 2016.
In addition to its two ongoing clinical studies of VX-970,
Vertex has entered into two cooperative research and development
agreements (CRADAs) with the National Cancer Institute to support
evaluation of VX-970 across other types of cancers. The CRADA
enables NCI to conduct multiple clinical studies that will evaluate
treatment with VX-970 in people with non-small cell lung, head and
neck, bladder, ovarian and other cancers. The first study conducted
under the CRADA with the NCI Center for Cancer Research is ongoing,
and the first of up to 7 planned studies under the NCI Division of
Cancer Treatment and Diagnosis sponsorship is expected to begin in
the first half of 2016.
Vertex is also developing a second ATR inhibitor known as
VX-803, which is dosed orally. An ongoing Phase 1 study is
evaluating escalating doses of VX-803 alone and in combination with
chemotherapy.
- VX-984: Phase 1 Study
Ongoing: Vertex is developing VX-984, an inhibitor of
DNA-dependent protein kinase that also targets the DNA damage
repair system. VX-984 may be evaluated in a variety of tumor types
in combination with commonly used chemotherapy and/or radiation
therapy. Vertex recently initiated the first clinical study of
VX-984. The study is evaluating escalating doses of VX-984 alone
and in combination with pegylated liposomal doxorubicin.
Pain – Two investigational medicines designed to inhibit
sodium channels involved in pain sensation
- VX-150: Phase 2
Proof-of-Concept Study in Osteoarthritis: Vertex is developing
VX-150 as a potential medicine for the treatment of pain. VX-150 is
designed to block pain signaling through inhibition of a sodium
channel known as NaV 1.8. Vertex recently completed a Phase 1 study
in healthy volunteers to evaluate the safety and pharmacokinetics
of VX-150. Based on data from this study, Vertex recently initiated
a 14-day Phase 2 proof-of-concept study of VX-150 in approximately
100 people with symptomatic osteoarthritis of the knee.
Additionally, Vertex is advancing a second investigational sodium
channel inhibitor known as VX-241, which is an inhibitor of a
sodium channel known as NaV 1.7. Vertex plans to begin clinical
development of VX-241 in the first half of 2016. There is a strong
rationale for exploring the treatment of pain through inhibition of
these two sodium channels based on human genetics and
well-documented roles in pain sensation.
Epithelial Sodium Channel (ENaC) Inhibition –Phase 2 study of
VX-371 in primary ciliary dyskinesia (PCD)
In addition to ongoing and planned Phase 2 studies of VX-371 in
cystic fibrosis, Vertex and Parion plan to begin the first study of
VX-371 in people with primary ciliary dyskinesia (PCD) in the
second half of 2016. PCD is a rare genetic disease that results in
a loss of function in key ciliary proteins. The defective proteins
lead to dysfunctional beating of cilia on the surface of cells,
especially in the lungs where the accumulation of mucus can lead to
chronic lung infections, bronchiectasis and progressive lung
function decline.
Acute Spinal Cord Injury – Phase 2 study of VX-210 planned
for first half of 2016
Vertex is developing VX-210 as a potential medicine for acute
spinal cord injury. VX-210 is designed to inhibit a protein known
as Rho that blocks neural regeneration after injury. A randomized,
double-blind, placebo controlled Phase 2b/3 study is expected to
begin in the first half of 2016 to evaluate the efficacy and safety
of VX-210 in patients with certain acute cervical spinal cord
injuries.
Influenza – Janssen advancing novel treatment for influenza
discovered by Vertex
JNJ-872 (VX-787) is an investigational medicine for the
treatment of influenza discovered by Vertex scientists and being
developed by Janssen. As part of the agreement with Janssen, Vertex
may receive development and commercial milestone payments as well
as royalties on future product sales.
CRISPR Collaboration – Gene editing collaboration focused on
genetic diseases, including sickle cell disease
In addition to the focus on the discovery of treatments to
address the mutations and genes known to cause and contribute to
cystic fibrosis, Vertex and CRISPR Therapeutics are seeking to
discover and develop multiple other gene-based treatments for other
genetic diseases. The companies will initially seek to discover and
develop gene-based treatments for hemoglobinopathies, including
sickle cell disease. Additional discovery efforts focused on a
specified number of other genetic targets will also be conducted
under the collaboration. Vertex has the option to an exclusive
license for up to six gene-based treatments that emerge from the
four-year research collaboration.
2015 Financial Highlights and 2016
Financial Outlook
"Entering 2016, we have significantly increased the number of
people being treated with our CF medicines, which results in
increased revenues and positions us to deliver growing earnings
while continuing to invest in the discovery of future medicines,”
said Ian Smith, Executive Vice President and Chief Financial
Officer for Vertex. “We have now begun an important transition
toward being a company that delivers earnings growth and sustained
profitability as we advance multiple potential new medicines for CF
and other diseases in the years ahead.”
The company will announce its complete year-end and fourth
quarter financial results on January 27, 2016 and today provided
selected financial results for 2015, as summarized below:
Preliminary 2015
Net Product Revenues*
FourthQuarter 2015
Full-year2015
ORKAMBI $220M $350M
KALYDECO
$180M $630M
TOTAL CF PRODUCT REVENUES $400M
$980M * Preliminary financial results are provided as
approximations in advance of the company’s complete financial
results announcement on January 27, 2016.
Vertex expects to report 2015 operating expenses, excluding cost
of revenues, (combined non-GAAP R&D and SG&A expenses) of
approximately $1.06 billion. The company entered 2016 with
approximately $1.04 billion in cash, cash equivalents and
marketable securities. As of December 31, 2015, Vertex had $300
million outstanding from a credit agreement that provides for a
secured loan of up to $500 million.
Vertex also today provided 2016 net product revenue guidance for
KALYDECO, guidance for non-GAAP operating expenses, excluding cost
of revenues, (combined non-GAAP R&D and SG&A expenses) and
an update on the company’s expectation for providing ORKAMBI net
revenue guidance in 2016, as summarized below:
2016 Financial
Guidance
KALYDECO Net Revenues $670 to $690M
Operating
Expenses, Excluding Cost of Revenues (Combined Non-GAAP R&D and
SG&A Expenses) $1.18 to $1.23B
- KALYDECO: Vertex anticipates
total 2016 KALYDECO net product revenues of $670 to $690 million,
which excludes any revenues related to the potential approval of
KALYDECO for people in the U.S. who have residual function
mutations. Anticipated 2016 KALYDECO net revenues reflect the
expectation for approximately 200 patients with a gating mutation
to enroll in a Phase 3 clinical study of VX-661 in combination with
ivacaftor who would otherwise receive KALYDECO, which will thus
reduce 2016 KALYDECO revenues.
- ORKAMBI: The company expects to
provide net product revenue guidance for ORKAMBI during 2016 after
gaining additional information on the launch of ORKAMBI in the
U.S., including:
- The total proportion of the 8,500
eligible patients who begin treatment with ORKAMBI in 2016.
- The rate at which patients initiate
treatment in 2016.
- The proportion of initiated patients
who remain on treatment.
- The compliance rate for patients who
remain on treatment.
As of December 31, more than 4,500 people had begun treatment
with ORKAMBI in the U.S. since the approval of the medicine in July
2015. Vertex expects the vast majority of eligible patients in the
U.S. will begin treatment by the end of 2016.
Vertex expects to recognize revenues from sales of ORKAMBI in
the U.S. and Germany in 2016. The company does not anticipate any
other significant revenues from European or other countries in
2016.
-- Operating Expenses, Excluding Cost of Revenues (Combined
Non-GAAP R&D and SG&A Expenses): Vertex expects that
its combined non-GAAP R&D and SG&A expenses in 2016 will be
in the range of $1.18 to $1.23 billion. The increase as compared to
2015 is primarily a result of expanded development efforts related
to the pivotal Phase 3 development program for VX-661 in
combination with ivacaftor and for multiple Phase 1 and 2 studies
of Vertex’s early-stage and mid-stage pipeline of potential CF
medicines and anticipated costs to support the launch of ORKAMBI in
new global markets. Vertex's expected non-GAAP R&D and SG&A
expenses exclude stock-based compensation expense and certain other
expenses the company anticipates recording in 2016.
U.S. INDICATION AND IMPORTANT SAFETY INFORMATION FOR
ORKAMBI® (lumacaftor/ivacaftor) TABLETS
ORKAMBI is a combination of lumacaftor and ivacaftor indicated
for the treatment of cystic fibrosis (CF) in patients age 12 years
and older who are homozygous for the F508del mutation in the CFTR
gene. The efficacy and safety of ORKAMBI have not been established
in patients with CF other than those homozygous for the F508del
mutation.
Worsening of liver function, including hepatic encephalopathy,
in patients with advanced liver disease has been reported in some
patients with CF while receiving ORKAMBI.
Serious adverse reactions related to elevated transaminases have
been reported in patients with CF receiving ORKAMBI and, in some
instances, associated with concomitant elevations in total serum
bilirubin.
Respiratory events (e.g., chest discomfort, shortness of breath,
and chest tightness) were observed more commonly in patients during
initiation of ORKAMBI compared to those who received placebo.
Clinical experience in patients with percent predicted FEV1 < 40
is limited, and additional monitoring of these patients is
recommended during initiation of therapy.
Co-administration of ORKAMBI with sensitive CYP3A substrates or
CYP3A substrates with a narrow therapeutic index is not recommended
as ORKAMBI may reduce their effectiveness. ORKAMBI may
substantially decrease hormonal contraceptive exposure, reducing
their effectiveness and increasing the incidence of
menstruation-associated adverse reactions. Co-administration with
strong CYP3A inducers is not recommended as they may reduce the
therapeutic effectiveness of ORKAMBI.
Abnormalities of the eye lens (cataracts) have been reported in
pediatric patients treated with ivacaftor, a component of
ORKAMBI.
The most common adverse reactions associated with ORKAMBI
include shortness of breath, sore throat, nausea, diarrhea, upper
respiratory tract infection, fatigue, chest tightness, increased
blood creatinine phosphokinase, rash, flatulence, runny nose, and
influenza.
Please see the full prescribing information for ORKAMBI.
U.S. INDICATION AND IMPORTANT SAFETY INFORMATION FOR
KALYDECO® (ivacaftor)
KALYDECO is a cystic fibrosis transmembrane conductance
regulatory (CFTR) potentiator indicated for the treatment of cystic
fibrosis (CF) in patients age 2 years and older who have one of the
following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R,
G551S, S1251N, S1255P, S549N, S549R or R117H.
KALYDECO is not effective in patients with CF with 2 copies of
the F508del mutation (F508del/F508del) in the CFTR gene. The safety
and efficacy of KALYDECO in children with CF younger than 2 years
of age have not been studied. The use of KALYDECO in children under
the age of 2 years is not recommended.
High liver enzymes (transaminases; ALT and AST) have been
reported in patients with CF receiving KALYDECO.
Use of KALYDECO with medicines that are strong CYP3A inducers
substantially decreases exposure of KALYDECO and may diminish
effectiveness. Therefore, co-administration is not recommended. The
dose of KALYDECO must be adjusted when used concomitantly with
strong and moderate CYP3A inhibitors or when used in patients with
moderate or severe hepatic disease.
Cases of non-congenital lens opacities/cataracts have been
reported in pediatric patients treated with KALYDECO.
The most common side effects associated with KALYDECO include
headache; upper respiratory tract infection (common cold),
including sore throat, nasal or sinus congestion, and runny nose;
stomach (abdominal) pain; diarrhea; rash; nausea; and
dizziness.
Please see the full prescribing information for KALYDECO.
About Vertex
Vertex is a global biotechnology company that aims to discover,
develop and commercialize innovative medicines so people with
serious diseases can lead better lives. In addition to our clinical
development programs focused on cystic fibrosis, Vertex has more
than a dozen ongoing research programs aimed at other serious and
life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research
and development sites and commercial offices in the United States,
Europe, Canada and Australia. For six years in a row, Science
magazine has named Vertex one of its Top Employers in the life
sciences. For additional information and the latest updates from
the company, please visit www.vrtx.com.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995,
including, without limitation, Dr. Leiden's statements in the third
paragraph of the press release, the information provided in the
section captioned "2015 Financial Highlights and 2016 Financial
Outlook" and statements regarding (i) preliminary financial
information for the quarter and year ended December 31, 2015 and
guidance for 2016; (ii) the target date for the FDA to review the
sNDA for the use of KALYDECO in children ages two and older with
one of 23 residual function mutation; and (iii) the expected timing
and clinical trial designs for ongoing and planned clinical studies
of lumacaftor/ivacaftor, VX-661, VX-371, the Company's
next-generation correctors (VX-152 and VX-440) and clinical studies
related to VX-970, VX-984, VX-150 and VX-210. While Vertex believes
the forward-looking statements contained in this press release are
accurate, there are a number of factors that could cause actual
events or results to differ materially from those indicated by such
forward-looking statements. Those risks and uncertainties include,
among other things, that the Company’s 2015 financial results are
preliminary and subject to adjustment, that the company's
expectations regarding its 2016 revenues and expenses may be
incorrect (including because one or more of the company's
assumptions underlying its expectations may not be realized), that
data from the company's development programs may not support
registration or further development of its compounds due to safety,
efficacy or other reasons, and other risks listed under Risk
Factors in Vertex's annual report and quarterly reports filed with
the Securities and Exchange Commission and available through the
company's website at www.vrtx.com. Vertex disclaims any obligation
to update the information contained in this press release as new
information becomes available.
Webcast Information
The company will webcast its corporate presentation at the 34th
Annual J.P. Morgan Healthcare Conference on Monday, January 11 at
9:30 a.m. PT (12:30 p.m. ET). The audio portion of management's
remarks can be accessed live through Vertex's website at
www.vrtx.com in the "Investors" section under the "Events and
Presentations" page.
(VRTX-GEN)
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Vertex Pharmaceuticals IncorporatedInvestors:Michael
Partridge, 617-341-6108orEric Rojas, 617-961-7205orZach Barber,
617-341-6470orMedia:617-341-6992mediainfo@vrtx.com
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