— Product revenues of $2.10 billion, a 22%
increase compared to Q1 2021 —
— Company reiterates full year 2022 product
revenue guidance of $8.4 to $8.6 billion —
— Mid- and late-stage clinical pipeline now
spans 6 disease areas —
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
reported consolidated financial results for the first quarter ended
March 31, 2022 and reiterated full year 2022 product revenue
guidance.
“Following upon our success in transforming the treatment of
cystic fibrosis, Vertex's unique and differentiated R&D
strategy continues to deliver with positive Phase 2
proof-of-concept studies in multiple disease areas, and another
wave of therapies set to enter the clinic in the second half of
this year," said Reshma Kewalramani, M.D., Chief Executive Officer
and President of Vertex. "With yet another quarter of strong
revenue performance characterized by 22% year-over-year growth, we
are well positioned for continued innovation and sustained growth
as we work to bring additional transformative medicines to more
patients around the globe."
First Quarter 2022 Financial
Highlights
Three Months Ended March
31,
%
2022
2021
Change
(in millions, except per share
amounts)
Product revenues, net
$
2,097
$
1,723
22
%
TRIKAFTA/KAFTRIO
$
1,762
$
1,193
SYMDEKO/SYMKEVI
$
65
$
125
ORKAMBI
$
132
$
219
KALYDECO
$
139
$
186
GAAP operating income
$
1,041
$
888
17
%
Non-GAAP operating income *
$
1,167
$
1,002
16
%
GAAP net income
$
762
$
653
17
%
Non-GAAP net income *
$
907
$
781
16
%
GAAP net income per share -
diluted
$
2.96
$
2.49
19
%
Non-GAAP net income per share - diluted
*
$
3.52
$
2.98
18
%
*
Starting in the first quarter of
2022, Vertex no longer excludes research and development charges
resulting from upfront or contingent milestone payments in
connection with collaborations, asset acquisitions and/or licensing
of third-party intellectual property rights from its Non-GAAP
financial measures. Non-GAAP financial measures for the first
quarter of 2021 have been recast to reflect this change.
Product revenues increased 22% to $2.10 billion compared
to the first quarter of 2021, primarily driven by the strong
launches of TRIKAFTA/KAFTRIO in multiple countries internationally
and the strong performance of TRIKAFTA in the U.S., including the
June 2021 launch of TRIKAFTA in children 6-11 years old in the U.S.
Net product revenues in the first quarter of 2022 increased 9% to
$1.37 billion in the U.S. and increased 55% to $729 million outside
the U.S., compared to the first quarter of 2021.
GAAP and Non-GAAP net income increased compared to the
first quarter of 2021, driven by strong product revenue growth.
Cash, cash equivalents and marketable securities as of
March 31, 2022 were $8.2 billion, an increase of approximately $0.7
billion compared to December 31, 2021. The increase was primarily
driven by strong revenue growth and operating cash flow.
First Quarter 2022
Expenses
Three Months Ended March
31,
2022
2021
(in millions)
Combined GAAP R&D and SG&A
expenses
$
818
$
648
Combined Non-GAAP R&D and SG&A
expenses *
$
687
$
531
GAAP R&D expenses
$
603
$
456
Non-GAAP R&D expenses *
$
520
$
380
GAAP SG&A expenses
$
215
$
192
Non-GAAP SG&A expenses
$
167
$
151
GAAP income taxes (1)
$
193
$
168
Non-GAAP income taxes *
$
249
$
206
GAAP effective tax rate (1)
20%
20%
Non-GAAP effective tax rate
22%
21%
*
Starting in the first quarter of
2022, Vertex no longer excludes research and development charges
resulting from upfront or contingent milestone payments in
connection with collaborations, asset acquisitions and/or licensing
of third-party intellectual property rights from its Non-GAAP
financial measures. Non-GAAP financial measures for the first
quarter of 2021 have been recast to reflect this change.
Combined GAAP and Non-GAAP R&D and SG&A expenses
increased compared to the first quarter of 2021, primarily due to
the progression of multiple product candidates into mid- to
late-stage clinical development and incremental investment to
support the launches of Vertex's therapies globally.
GAAP and Non-GAAP income taxes increased compared to the
first quarter of 2021, primarily due to Vertex's increased
operating income.
Full Year 2022 Financial
Guidance
Vertex today reiterated full year 2022 product revenue guidance.
Vertex's guidance is summarized below:
Current FY 2022
Previous FY 2022
Product revenues
Unchanged
$8.4 to $8.6 billion
Combined GAAP R&D and SG&A
expenses (2)
Unchanged
$3.30 to $3.45 billion
Combined Non-GAAP R&D and SG&A
expenses (2) *
$2.82 to $2.92 billion
$2.70 to $2.75 billion
Non-GAAP effective tax rate
Unchanged
21% to 22%
*
Starting in the first quarter of
2022, Vertex no longer excludes research and development charges
resulting from upfront or contingent milestone payments in
connection with collaborations, asset acquisitions and/or licensing
of third-party intellectual property rights from its Non-GAAP
financial measures.
Key Business Highlights
Cystic Fibrosis (CF) Marketed
Products
Vertex anticipates the number of CF patients treated with our
medicines will continue to grow as the uptake of TRIKAFTA in the
U.S. and the launches of KAFTRIO outside the U.S. continue, and as
we enter into additional reimbursement agreements and achieve new
approvals for the treatment of younger patients. Recent progress
includes:
- Health Canada granted marketing authorization for TRIKAFTA in
children 6 to 11 years of age. With this approval, approximately
500 children with CF are newly eligible for treatment with a CFTR
modulator.
- Vertex signed a reimbursement agreement with the Australian
Pharmaceutical Benefits Scheme for TRIKAFTA®
(ivacaftor/tezacaftor/elexacaftor) for the treatment of patients
with cystic fibrosis 12 years and older with at least one F508del
mutation in the CF transmembrane conductance regulator (CFTR) gene.
With this agreement, approximately 700 people in Australia will
have access to a CFTR modulator therapy for the first time.
- Vertex completed enrollment in the Phase 3 study of
TRIKAFTA/KAFTRIO in children 2 to 5 years old. The Company
anticipates filing a supplementary new drug application (sNDA) with
the FDA before the end of 2022.
- In March, Vertex filed an sNDA with the FDA for ORKAMBI for the
use of ORKAMBI in children 12 months to less than 24 months old.
Vertex intends to submit regulatory filings in Europe in Q2
2022.
- In January, the European Commission and the UK’s Medicines and
Healthcare Products Regulatory Agency (MHRA) approved a label
extension for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a
combination regimen with ivacaftor, for the treatment of CF in
children ages 6 through 11 years old who have at least one F508del
mutation in the CF transmembrane conductance regulator (CFTR) gene.
With these approvals, approximately 1,900 children are newly
eligible for KAFTRIO®.
- In 2021, Vertex presented the first long-term follow-up data
for TRIKAFTA, demonstrating no loss in mean lung function at 96
weeks, a first for any CFTR modulator to date in people with F/F
and F/MF mutations. Vertex has now completed a comparison of
long-term data in TRIKAFTA patients to matched untreated controls,
and will present these data at an upcoming medical congress.
TRIKAFTA/KAFTRIO is now approved and reimbursed or accessible in
more than 25 countries.
R&D pipeline
Vertex is delivering on a diversified pipeline of potentially
transformative small molecule, cell and genetic therapies aimed at
serious diseases. Recent and anticipated progress for key pipeline
programs is summarized below.
Cystic Fibrosis
Vertex continues to pursue next-in-class, small molecule CFTR
modulator therapies as well as new treatment options for the
approximately 5,000 patients who cannot benefit from CFTR
modulators alone.
- Vertex is conducting two Phase 3 global, randomized,
double-blind, active-controlled clinical trials (SKYLINE 102 and
SKYLINE 103) evaluating Vertex’s new once-daily investigational
triple combination of VX-121/tezacaftor/VX-561 in patients with CF.
The SKYLINE 102 and SKYLINE 103 trials will compare the efficacy
and safety of VX-121/tezacaftor/VX-561 to TRIKAFTA. More than 180
sites across both studies are open and enrolling, and enrollment in
both trials is expected to be completed in late 2022 or early
2023.
- In collaboration with Moderna, Vertex is developing CF mRNA
therapeutics designed to treat the underlying cause of CF by
programming cells in the lungs to produce functional CFTR protein
for the treatment of the approximately 5,000 people with CF who do
not produce any CFTR protein. IND-enabling studies have been
completed, and Vertex is on track to submit an IND for this program
in 2H 2022.
Beta Thalassemia and Sickle Cell Disease (SCD)
The CTX001 program employs a non-viral ex vivo CRISPR
gene-editing therapy, which is being developed as a potential
functional cure for transfusion-dependent thalassemia (TDT) and
severe sickle cell disease (SCD). Vertex is developing CTX001 in
collaboration with CRISPR Therapeutics.
- Enrollment is complete in the ongoing Phase 3 clinical trials
in TDT and SCD, with more than 75 patients dosed to date. Vertex
anticipates presenting updated data from the clinical trials, with
more patients and longer follow-up, at medical conferences in
2022.
- Two new Phase 3 studies of CTX001 were initiated in pediatric
patients with TDT and SCD.
- Vertex plans to submit global regulatory filings for CTX001 in
TDT and SCD in late 2022.
APOL1-Mediated Kidney Disease (AMKD)
Vertex has discovered multiple oral, small molecule inhibitors
of APOL1 function, pioneering a new class of medicines that target
an underlying genetic driver of kidney disease.
- In March, Vertex initiated pivotal development of VX-147 in a
single Phase 2/3 study in patients with AMKD with two APOL1
mutations and proteinuric kidney disease.
- This Phase 2/3 adaptive study will first evaluate two doses of
VX-147 to select a dose for Phase 3 and subsequently evaluate the
efficacy and safety of the single, selected dose in the Phase 3
portion of the study. The primary efficacy endpoint for the final
analysis is eGFR slope in patients receiving the VX-147 selected
dose compared to placebo at two years. The study is designed to
have a pre-planned interim analysis at Week 48 evaluating eGFR
slope, supported by a percent change from baseline in proteinuria
in the VX-147 arm versus placebo. If positive, the interim analysis
may serve as the basis for Vertex to seek accelerated approval of
VX-147 in the U.S. for patients with AMKD.
Pain (NaV1.8)
Vertex has discovered multiple selective small molecule
inhibitors of NaV1.8 with the objective of creating a new class of
pain medicines that have the potential to provide effective pain
relief, without the limitations of opioids.
- In March, Vertex reported positive data from two Phase 2 dose
ranging acute pain studies with VX-548, one following bunionectomy
surgery and the other following abdominoplasty surgery. Both
studies met their primary endpoint and established proof of concept
for VX-548.
- Vertex plans to advance VX-548 into pivotal development in
acute pain in the second half of 2022, following discussions with
regulators.
Type 1 Diabetes (T1D)
Vertex is evaluating cell therapies using stem cell-derived
islets to replace the endogenous insulin-producing islet cells that
are destroyed in people with T1D with the goal of developing a
potential functional cure for this disease.
- VX-880 is a stem cell-derived, fully differentiated islet
replacement therapy, used in combination with standard
immunosuppression to protect the implanted cells. VX-880 is being
evaluated in a Phase 1/2 clinical trial for the treatment of
T1D.
- This program has been placed on clinical hold in the U.S. by
the FDA, based on their determination of insufficient information
for dose escalation with the product. Vertex is working
collaboratively and with urgency to understand and address the
FDA’s questions.
- Vertex previously announced:
- The first patient, who received a half dose of VX-880, is
insulin-independent with an HbA1C of 5.2% at Day 270.
- The second patient, who also received a half dose of VX-880,
demonstrated restoration of glucose-responsive insulin production
and significant improvement in glycemic control with reductions in
exogenous insulin requirements.
- Taken together, results in the first two patients establish
proof-of-concept for VX-880 in the treatment of T1D. Per protocol,
the Independent Data Monitoring Committee reviewed the totality of
the safety data from the first two patients dosed and recommended
advancement to Part B of the study, and treatment with the full
target dose.
- The third patient treated with VX-880 received the full target
dose and has reached the Day 29 follow-up milestone.
- Across the program, VX-880 has been generally well tolerated to
date. There have been no serious adverse events (SAEs) considered
related to VX-880. The majority of adverse events (AEs) were mild
or moderate in all patients treated to date. The safety profile was
generally consistent with the immunosuppressive regimen used in the
study and the perioperative period.
- Vertex is continuing to advance additional programs in T1D, in
which these same stem cell-derived islets are encapsulated and
implanted in an immunoprotective device or modified to produce
hypoimmune stem cell islets with the goal of eliminating the need
for immunosuppression.
- Vertex is on track to submit an IND for the cells plus device
program in 2022.
Vertex expects to share additional data for VX-880 at medical
conferences this year.
Alpha-1 Antitrypsin (AAT) Deficiency
Vertex is working to address the underlying genetic cause of
alpha-1 antitrypsin (AAT) deficiency by developing novel small
molecule correctors of Z-AAT protein folding, with a goal of
increasing the secretion of functional AAT into the blood and
addressing both the lung and the liver aspects of AAT
deficiency.
- Vertex is on track to advance one or more novel small molecule
Z-AAT correctors into the clinic in 2022.
Duchenne Muscular Dystrophy (DMD)
Vertex is investigating a novel approach to treating DMD by
delivering CRISPR/Cas9 gene-editing technology to muscle cells with
the goal of restoring near-full length dystrophin protein
expression by targeting specific mutations in the dystrophin gene
that cause the disease.
- Vertex has advanced its first in vivo gene editing therapy for
DMD into IND-enabling studies.
Consistent with its overall strategy, Vertex takes a portfolio
approach to all of its programs, with additional assets in CF, SCD,
Beta Thalassemia, AMKD, T1D, Pain, and AATD in earlier stages of
development.
Non-GAAP Financial
Measures
In this press release, Vertex's financial results and financial
guidance are provided in accordance with accounting principles
generally accepted in the United States (GAAP) and using certain
non-GAAP financial measures. In particular, non-GAAP financial
results and guidance exclude from Vertex's pre-tax income (i)
stock-based compensation expense, (ii) gains or losses related to
the fair value of the company's strategic investments, (iii)
increases or decreases in the fair value of contingent
consideration, (iv) acquisition-related costs and (v) other
adjustments. The company's non-GAAP financial results also exclude
from its provision for income taxes the estimated tax impact
related to its non-GAAP adjustments to pre-tax income described
above and certain discrete items. These results should not be
viewed as a substitute for the company’s GAAP results and are
provided as a complement to results provided in accordance with
GAAP. Management believes these non-GAAP financial measures help
indicate underlying trends in the company's business, are important
in comparing current results with prior period results and provide
additional information regarding the company's financial position
that the company believes is helpful to an understanding of its
ongoing business. Management also uses these non-GAAP financial
measures to establish budgets and operational goals that are
communicated internally and externally, to manage the company's
business and to evaluate its performance. The company’s calculation
of non-GAAP financial measures likely differs from the calculations
used by other companies. A reconciliation of the GAAP financial
results to non-GAAP financial results is included in the attached
financial information.
The company provides guidance regarding combined R&D and
SG&A expenses and effective tax rate on a non-GAAP basis. The
guidance regarding combined GAAP and non-GAAP R&D and SG&A
expenses does not include estimates associated with any potential
future business development transactions, including collaborations,
asset acquisitions and/or licensing of third-party intellectual
property rights. The company does not provide guidance regarding
its GAAP effective tax rate because it is unable to forecast with
reasonable certainty the impact of excess tax benefits related to
stock-based compensation and the possibility of certain discrete
items, which could be material.
Vertex Pharmaceuticals Incorporated
Consolidated Statements of Operations (in millions, except
per share amounts) (unaudited)
Three Months Ended March
31,
2022
2021
Revenues:
Product revenues, net
$
2,097.5
$
1,723.3
Other revenues
—
1.0
Total revenues
2,097.5
1,724.3
Costs and expenses:
Cost of sales
245.8
192.3
Research and development expenses
603.1
456.0
Selling, general and administrative
expenses
215.2
192.1
Change in fair value of contingent
consideration
(7.5
)
(3.9
)
Total costs and expenses
1,056.6
836.5
Income from operations
1,040.9
887.8
Interest income
1.6
1.5
Interest expense
(14.9
)
(15.7
)
Other expense, net
(72.8
)
(52.7
)
Income before provision for income
taxes
954.8
820.9
Provision for income taxes
192.7
167.8
Net income
$
762.1
$
653.1
Net income per common share:
Basic
$
2.99
$
2.52
Diluted
$
2.96
$
2.49
Shares used in per share calculations:
Basic
255.1
259.4
Diluted
257.9
261.9
Vertex Pharmaceuticals Incorporated
Reconciliation of GAAP to Non-GAAP Net Income and Operating
Income (in millions, except per share amounts) (unaudited)
Three Months Ended March
31,
2022
2021
GAAP net income
$
762.1
$
653.1
Stock-based compensation expense
130.3
115.2
Decrease in fair value of strategic
investments (3)
75.6
52.3
Decrease in fair value of contingent
consideration (4)
(7.5
)
(3.9
)
Acquisition-related costs (5)
2.8
2.8
Total non-GAAP adjustments to pre-tax
income *
201.2
166.4
Tax adjustments (1) *
(56.2
)
(38.2
)
Non-GAAP net income *
$
907.1
$
781.3
Net income per diluted common share:
GAAP
$
2.96
$
2.49
Non-GAAP *
$
3.52
$
2.98
Shares used in diluted per share
calculations:
GAAP and Non-GAAP
257.9
261.9
Three Months Ended March
31,
2022
2021
GAAP operating income
$
1,040.9
$
887.8
Stock-based compensation expense
130.3
115.2
Decrease in fair value of contingent
consideration (4)
(7.5
)
(3.9
)
Acquisition-related costs (5)
2.8
2.8
Non-GAAP operating income *
$
1,166.5
$
1,001.9
Vertex Pharmaceuticals Incorporated
Reconciliation of GAAP to Non-GAAP Expenses (in millions,
except percentages) (unaudited)
Three Months Ended March
31,
2022
2021
GAAP cost of sales
$
245.8
$
192.3
Stock-based compensation expense
(2.2
)
(1.4
)
Non-GAAP cost of sales
$
243.6
$
190.9
GAAP research and development
expenses
$
603.1
$
456.0
Stock-based compensation expense
(80.4
)
(72.8
)
Acquisition-related costs (5)
(2.8
)
(2.8
)
Non-GAAP research and development
expenses *
$
519.9
$
380.4
GAAP selling, general and
administrative expenses
$
215.2
$
192.1
Stock-based compensation expense
(47.7
)
(41.0
)
Non-GAAP selling, general and
administrative expenses
$
167.5
$
151.1
Combined non-GAAP R&D and SG&A
expenses *
$
687.4
$
531.5
Three Months Ended March
31,
2022
2021
GAAP other expense, net
$
(72.8
)
$
(52.7
)
Decrease in fair value of strategic
investments (3)
75.6
52.3
Non-GAAP other income (expense),
net
$
2.8
$
(0.4
)
GAAP provision for income taxes
$
192.7
$
167.8
Tax adjustments (1) *
56.2
38.2
Non-GAAP provision for income taxes
*
$
248.9
$
206.0
GAAP effective tax rate
20
%
20
%
Non-GAAP effective tax rate
22
%
21
%
*
Starting in the first quarter of
2022, Vertex no longer excludes research and development charges
resulting from upfront or contingent milestone payments in
connection with collaborations, asset acquisitions and/or licensing
of third-party intellectual property rights from its Non-GAAP
financial measures. Non-GAAP financial measures for the first
quarter of 2021 have been recast to reflect this change.
Vertex Pharmaceuticals
Incorporated Condensed Consolidated Balance Sheets (in
millions) (unaudited)
March 31, 2022
December 31, 2021
Assets
Cash, cash equivalents and marketable
securities
$
8,238.1
$
7,524.9
Accounts receivable, net
1,292.8
1,136.8
Inventories
338.9
353.1
Property and equipment, net
1,107.4
1,094.1
Goodwill and intangible assets
1,402.2
1,402.2
Deferred tax assets
945.5
934.5
Other assets
931.2
986.9
Total assets
$
14,256.1
$
13,432.5
Liabilities and Shareholders'
Equity
Accounts payable and accrued expenses
$
1,894.1
$
1,873.6
Finance lease liabilities
544.2
556.7
Contingent consideration
179.0
186.5
Other liabilities
731.8
715.7
Shareholders' equity
10,907.0
10,100.0
Total liabilities and shareholders'
equity
$
14,256.1
$
13,432.5
Common shares outstanding
255.6
254.5
Notes and Explanations
1: In the three months ended March 31, 2022 and 2021,
"Tax adjustments" included the estimated income taxes related to
non-GAAP adjustments to the company's pre-tax income and excess tax
benefits related to stock-based compensation.
2: The difference between the company’s full year 2022
combined GAAP R&D and SG&A expenses and combined non-GAAP
R&D and SG&A expenses guidance relates primarily to $440
million to $510 million of stock-based compensation expense. The
guidance regarding combined GAAP and non-GAAP R&D and SG&A
expenses does not include estimates associated with any potential
future business development transactions, including collaborations,
asset acquisitions and/or licensing of third-party intellectual
property rights.
3: "Other expense, net" includes net gains and losses
related to changes in the fair value of the company's strategic
investments.
4: During the three months ended March 31, 2022 and 2021,
the change in the fair value of contingent consideration relates to
potential payments to Exonics Therapeutics' former equity
holders.
5: "Acquisition-related costs" in the three months ended
March 31, 2022 and 2021 related to costs associated with the
company's acquisition of Exonics Therapeutics in 2019.
Note:
Amounts may not foot due to rounding.
About Vertex
Vertex is a global biotechnology company that invests in
scientific innovation to create transformative medicines for people
with serious diseases. The company has multiple approved medicines
that treat the underlying cause of cystic fibrosis (CF) — a rare,
life-threatening genetic disease — and has several ongoing clinical
and research programs in CF. Beyond CF, Vertex has a robust
pipeline of investigational small molecule medicines in other
serious diseases where it has deep insight into causal human
biology, including pain, alpha-1 antitrypsin deficiency and
APOL1-mediated kidney disease. In addition, Vertex has a rapidly
expanding pipeline of cell and genetic therapies for diseases such
as sickle cell disease, beta thalassemia, Duchenne muscular
dystrophy and type 1 diabetes mellitus.
Founded in 1989 in Cambridge, Mass., Vertex's global
headquarters is now located in Boston's Innovation District and its
international headquarters is in London. Additionally, the company
has research and development sites and commercial offices in North
America, Europe, Australia and Latin America. Vertex is
consistently recognized as one of the industry's top places to
work, including 12 consecutive years on Science magazine's Top
Employers list and one of the 2021 Seramount (formerly Working
Mother Media) 100 Best Companies. For company updates and to learn
more about Vertex's history of innovation, visit www.vrtx.com or
follow us on Facebook, Twitter, LinkedIn, YouTube and
Instagram.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended, including, without limitation, Dr. Kewalramani's
statements in this press release, the information provided
regarding future financial performance and operations, the section
captioned "Full Year 2022 Financial Guidance" and statements
regarding (i) anticipated regulatory discussions and filings, data
availability, and timing thereof, (ii) the expectations,
development plans and anticipated timelines for the company's
products and product candidates and pipeline programs, including
study designs, patient enrollment, data availability and timing
thereof, (iii) expectations for continued growth in the number of
CF patients treated with our medicines, including the number of
children newly eligible for TRIKAFTA/KAFTRIO, uptake of and
expanded access to the company’s medicines, additional
reimbursement agreements, new approvals, including market
authorizations and label extensions outside of the U.S., and
expansion of treatment options for the patients who cannot benefit
from CFTR modulators, (iv) expectations regarding our collaboration
with Moderna to develop CF mRNA therapeutics, including our plans
to submit an IND for this program in 2022, (v) anticipated
presentations of data and global regulatory filings for CTX001 in
late 2022, (vi) expectations regarding the potential benefits of
our pain program and products, and plans for the advancement of
VX-548 into pivotal development in acute pain in the second half of
2022, (vii) the potential benefits and safety of VX-880, our plans
and expectations regarding interactions with the FDA, including our
ability to resume our Phase 1/2 program for VX-880 at U.S. sites,
and our plans to continue to progress the Phase 1/2 program for
VX-880, (viii) our plans and expectations regarding our additional
programs in T1D, including the completion of IND-enabling studies
for the encapsulated islet cell program and anticipated regulatory
filings in 2022, (ix) plans to advance one or more novel small
molecule zAAT correctors into the clinic in 2022, (x) our plans
regarding our Phase 2/3 study of VX-147 in AMKD, and our beliefs
regarding anticipated results of the study and the possibility for
accelerated approval in the U.S. and (xi) our plans regarding our
DMD program. While Vertex believes the forward-looking statements
contained in this press release are accurate, these forward-looking
statements represent the company's beliefs only as of the date of
this press release and there are a number of risks and
uncertainties that could cause actual events or results to differ
materially from those expressed or implied by such forward-looking
statements. Those risks and uncertainties include, among other
things, that the company's expectations regarding its 2022 product
revenues, expenses and effective tax rates may be incorrect
(including because one or more of the company's assumptions
underlying its expectations may not be realized), that the company
may not be able to submit the anticipated regulatory filings on the
expected timeline, or at all, that external factors may have
different or more significant impacts on the company's business or
operations than the company currently expects, that data from
preclinical testing or clinical trials, especially if based on a
limited number of patients, may not be indicative of final results
or available on anticipated timelines, that the company may not
realize the anticipated benefits from our collaborations with third
parties, that data from the company's development programs may not
support registration or further development of its potential
medicines in a timely manner, or at all, due to safety, efficacy or
other reasons, and other risks listed under the heading “Risk
Factors” in Vertex's annual report and subsequent quarterly reports
filed with the Securities and Exchange Commission (SEC) and
available through the company's website at www.vrtx.com and on the
SEC’s website at www.sec.gov. You should not place undue reliance
on these statements, or the scientific data presented. Vertex
disclaims any obligation to update the information contained in
this press release as new information becomes available.
Conference Call and
Webcast
The company will host a conference call and webcast at 4:30 p.m.
ET. To access the call, please dial (877) 270-2148 (U.S.) or +1
(412) 902-6510 (International) and reference the “Vertex
Pharmaceuticals First Quarter 2022 Earnings Call”.
The conference call will be webcast live and a link to the
webcast can be accessed through Vertex's website at www.vrtx.com in
the "Investors" section. To ensure a timely connection, it is
recommended that participants register at least 15 minutes prior to
the scheduled webcast. An archived webcast will be available on the
company's website.
(VRTX-E)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220505005999/en/
Vertex: Investors: Michael Partridge, 617-341-6108
or Manisha Pai, 617-961-1899 or Miroslava Minkova, 617-341-6135
Media: 617-341-6992 mediainfo@vrtx.com
Vertex Pharmaceuticals (NASDAQ:VRTX)
過去 株価チャート
から 6 2024 まで 7 2024
Vertex Pharmaceuticals (NASDAQ:VRTX)
過去 株価チャート
から 7 2023 まで 7 2024