-Full-year 2020 GAAP product revenues of $6.20
billion-
-Full-year 2020 non-GAAP product revenues of
$6.20 billion, a 55% increase compared to full-year 2019-
-Company provides full-year 2021 product
revenue guidance of $6.7 to $6.9 billion-
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
reported consolidated financial results for the full year and
fourth quarter ended December 31, 2020 and provided full-year 2021
financial guidance.
"Our achievements in 2020 were marked by a significant increase
in the number of people treated with the triple combination in the
U.S. and the EU. It was also a year marked by meaningful pipeline
advancement. We now have clinical programs in seven disease areas,
spanning multiple modalities including small molecules for alpha-1
antitrypsin deficiency and APOL1-mediated kidney diseases, gene
editing for sickle cell disease and beta thalassemia, and cell
therapy for type 1 diabetes,” said Reshma Kewalramani, M.D., Chief
Executive Officer and President of Vertex. "As we enter 2021, we
look forward to treating more CF patients and reaching important
R&D milestones in multiple additional diseases which will fuel
our growth this year and for many years to come."
Fourth-Quarter and Full-Year 2020
Financial Highlights
Three Months Ended December
31,
%
Twelve Months Ended December
31,
%
2020
2019
Change
2020
2019
Change
(in millions, except per share
amounts)
GAAP Product revenues, net
$
1,627
$
1,413
15
%
$
6,203
$
4,161
49
%
Non-GAAP Product revenues, net
(1)
$
1,627
$
1,257
29
%
$
6,203
$
4,005
55
%
GAAP Operating income
$
746
$
551
35
%
$
2,856
$
1,198
139
%
Non-GAAP Operating income
$
887
$
593
50
%
$
3,491
$
1,786
95
%
GAAP Net income
$
604
$
583
4
%
$
2,712
$
1,177
130
%
Non-GAAP Net income
$
661
$
444
49
%
$
2,719
$
1,389
96
%
GAAP Net income per share -
diluted
$
2.30
$
2.23
3
%
$
10.29
$
4.51
128
%
Non-GAAP Net income per share -
diluted
$
2.51
$
1.70
48
%
$
10.32
$
5.33
94
%
Full-Year 2020 Results
Twelve Months Ended December
31,
2020
2019
(in millions)
GAAP Product revenues, net
$
6,203
$
4,161
Non-GAAP Product revenues, net
(1)
$
6,203
$
4,005
TRIKAFTA/KAFTRIO
$
3,864
$
420
SYMDEKO/SYMKEVI
$
629
$
1,418
ORKAMBI
$
908
$
1,176
KALYDECO
$
803
$
991
GAAP and Non-GAAP product revenues increased 49% and 55%,
respectively, compared to 2019, primarily driven by the uptake of
TRIKAFTA in the U.S., KAFTRIO in Europe and our other medicines
outside the U.S. following the completion of several significant
reimbursement agreements. Net product revenues in 2020 were $4.8
billion in the U.S. and $1.4 billion outside the U.S.
GAAP and Non-GAAP net income increased compared to 2019,
largely driven by strong growth in product revenues.
Cash, cash equivalents and marketable securities as of
December 31, 2020 were $6.7 billion, an increase of approximately
$2.9 billion compared to $3.8 billion as of December 31, 2019
driven by strong revenue and profitability.
Full-Year 2020 Expenses
Twelve Months Ended December
31,
2020
2019
(in millions)
Combined GAAP R&D and SG&A
expenses
$
2,600
$
2,413
Combined Non-GAAP R&D and SG&A
expenses
$
1,981
$
1,694
GAAP R&D expense
$
1,830
$
1,755
Non-GAAP R&D expense
$
1,372
$
1,171
GAAP SG&A expense
$
770
$
658
Non-GAAP SG&A expense
$
609
$
523
GAAP income taxes
$
405
$
218
Non-GAAP income taxes
$
721
$
397
GAAP effective tax rate
13
%
16
%
Non-GAAP effective tax rate (2)
21
%
22
%
Combined GAAP and Non-GAAP R&D and SG&A expenses
increased compared to 2019, primarily due to the incremental
investment to support the global use of Vertex's medicines and the
expansion of Vertex's pipeline in CF and other disease areas.
GAAP and Non-GAAP income taxes increased compared to 2019
primarily due to Vertex's increased operating income. Refer to the
"Supplemental Income Tax Information" section for discussion of the
cash versus non-cash components of Vertex's provision for income
taxes.
Fourth-Quarter 2020
Results
Three Months Ended December
31,
2020
2019
(in millions)
GAAP Product revenues, net
$
1,627
$
1,413
Non-GAAP Product revenues, net
(1)
$
1,627
$
1,257
TRIKAFTA/KAFTRIO
$
1,091
$
420
SYMDEKO/SYMKEVI
$
128
$
332
ORKAMBI
$
215
$
270
KALYDECO
$
193
$
236
GAAP and Non-GAAP product revenues increased 15% and 29%,
respectively, compared to the fourth quarter of 2019, primarily
driven by the uptake of TRIKAFTA in the U.S., KAFTRIO in Europe and
our other medicines outside the U.S. following the completion of
several significant reimbursement agreements.
GAAP and non-GAAP net income increased compared to the
fourth quarter of 2019, largely driven by strong growth in total
product revenues.
Fourth-Quarter 2020
Expenses
Three Months Ended December
31,
2020
2019
(in millions)
Combined GAAP R&D and SG&A
expenses
$
678
$
675
Combined Non-GAAP R&D and SG&A
expenses
$
539
$
496
GAAP R&D expense
$
467
$
480
Non-GAAP R&D expense
$
364
$
337
GAAP SG&A expense
$
212
$
195
Non-GAAP SG&A expense
$
175
$
159
GAAP income taxes
$
284
$
94
Non-GAAP income taxes
$
198
$
145
GAAP effective tax rate
32
%
14
%
Non-GAAP effective tax rate (2)
23
%
25
%
Combined GAAP R&D and SG&A expenses were similar
to the fourth quarter of 2019.
Combined Non-GAAP R&D and SG&A expenses increased
compared to the fourth quarter of 2019, primarily due to the
incremental investment to support the global use of Vertex's
medicines and the expansion of Vertex's pipeline in CF and other
disease areas.
GAAP and Non-GAAP income taxes increased compared to the
fourth quarter of 2019 primarily due to Vertex's increased
operating income. Refer to the "Supplemental Income Tax
Information" section for discussion of the cash versus non-cash
components of Vertex's provision for income taxes.
Full-Year 2021 Financial
Guidance
Vertex today provided its full-year 2021 financial guidance.
Product revenue guidance is primarily based on:
- The continued strong performance of TRIKAFTA in the U.S. and
KAFTRIO in certain European countries
- The launch of medicines in the U.S. for rare mutations
following approval in December 2020 and the approval of TRIKAFTA
for children with CF ages 6-11 in the U.S. expected mid-year
- Countries where patients currently have access or
reimbursement
Vertex's guidance is summarized below:
FY 2021
Product revenues
$6.7 to 6.9 billion
Combined GAAP R&D and SG&A
expenses (3)
$2.9 to 3.05 billion
Combined Non-GAAP R&D and SG&A
expenses (3)
$2.25 to 2.3 billion
Non-GAAP effective tax rate
21% to 22%
Key Business Highlights
Cystic Fibrosis (CF) R&D
pipeline
Vertex expects to increase the number of CF patients eligible to
take our medicines and thereby continue to grow our CF business.
Important progress has been made in increasing the number of
eligible patients and expanding approval and access for our
medicines to additional geographies and age groups.
TRIKAFTA/KAFTRIO (elexacaftor, tezacaftor and
ivacaftor)
- The U.S. Food and Drug Administration (FDA) expanded the
eligibility for TRIKAFTA to include people with CF ages 12 and
older with certain mutations that are responsive to TRIKAFTA based
on in vitro data. SYMDEKO and KALYDECO also received approvals to
include additional responsive mutations in people with CF ages 6
and older and ages 4 months and older, respectively.
- Swissmedic, the Swiss Agency for Therapeutic Products, granted
marketing authorization and a reimbursement agreement was reached
for TRIKAFTA in Switzerland in people with CF ages 12 and older
with two F508del mutations or one F508del mutation and one minimal
function mutation.
- The U.S. FDA accepted a supplemental New Drug Application
(sNDA) for TRIKAFTA for the treatment of children with CF ages 6 to
11 who have at least one F508del mutation or have certain mutations
that are responsive to TRIKAFTA based on in vitro data. The FDA
granted Priority Review of the sNDA and assigned a Prescription
Drug User Fee Act (PDUFA) target action date of June 8, 2021.
- Health Canada accepted a New Drug Submission for Priority
Review for TRIKAFTA for the treatment of people with CF ages 12
years and older.
SYMDEKO/SYMKEVI (tezacaftor and ivacaftor)
- The European Commission (EC) granted approval of the label
extension for SYMKEVI to include people with CF ages 6 years and
older with two copies of the F508del mutation or one copy of the
F508del mutation and certain residual function mutations.
KALYDECO (ivacaftor)
- The EC granted approval of the label extension for KALYDECO to
include the treatment of infants with CF ages 4 months and older
who have R117H or certain gating mutations.
R&D pipeline outside of
CF
Vertex continues to progress a broad pipeline of potentially
transformative small molecule, cell and genetic therapies aimed at
serious diseases. Recent and anticipated progress for key pipeline
programs is noted below:
Beta Thalassemia and Sickle Cell Disease
- Vertex and its partner CRISPR Therapeutics are evaluating the
use of an ex vivo CRISPR gene-edited therapy for the treatment of
transfusion-dependent beta thalassemia (TDT) and sickle cell
disease (SCD). This approach aims to edit a person’s hematopoietic
stem cells to produce fetal hemoglobin in red blood cells, which
has the potential to reduce or eliminate symptoms associated with
disease.
- Enrollment and dosing are ongoing in the clinical studies for
CTX001. More than 20 patients have been dosed with CTX001 across
both studies to date. Completion of enrollment in both studies is
expected in 2021.
Alpha-1 Antitrypsin (AAT) Deficiency
- Vertex is evaluating multiple compounds with the potential to
correct the misfolding of Z-AAT protein in the liver, in order to
increase the levels of functional AAT in the blood. Misfolded Z-AAT
protein is the root cause of AAT deficiency.
- Enrollment is ongoing in a Phase 2 proof-of-concept study for
the Z-AAT corrector, VX-864. Data from this study is expected in
the first half of 2021.
APOL1-mediated Kidney Diseases
- Vertex is evaluating the potential for inhibitors of APOL1
function to reduce proteinuria in people with serious kidney
diseases, including focal segmental glomerulosclerosis (FSGS).
- Enrollment is ongoing in a Phase 2 proof-of-concept study
designed to evaluate the reduction in proteinuria in people with
APOL1-mediated FSGS after treatment with VX-147. Data from this
study is expected in 2021.
Type 1 Diabetes (T1D)
- Vertex is developing a cell therapy designed to replace
insulin-producing islet cells in people with T1D. Two opportunities
exist for the transplant of these functional islets into patients:
1) transplantation of islet cells alone, using immunosuppression to
protect the implanted cells and 2) implantation of the islet cells
inside a novel immunoprotective device.
- The U.S. FDA cleared the Investigational New Drug Application
(IND) for VX-880, the islet cells alone program. Vertex expects to
initiate a Phase 1/2 clinical trial in the first half of 2021.
Investments in External
Innovation
- Skyhawk Therapeutics and Vertex established a strategic
collaboration to discover and develop novel small molecules that
modulate RNA splicing for the treatment of serious diseases.
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) an adjustment to product
revenues and related cost of sales to reflect the conclusion of the
early access program for ORKAMBI in France in the fourth quarter of
2019, (iii) revenues and expenses related to collaboration
agreements, (iv) gains or losses related to the fair value of the
company's strategic investments, (v) increases or decreases in the
fair value of contingent consideration, (vi) acquisition-related
costs and (vii) 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
adjusts, where appropriate, for both revenues and expenses in order
to reflect the company's operations. 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 R&D and SG&A expenses does
not include estimates associated with any potential future business
development activities. The company does not provide a 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
Fourth-Quarter Results
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
Revenues:
Product revenues, net
$
1,626,920
$
1,413,265
$
6,202,783
$
4,160,726
Collaboration and royalty revenues
900
—
2,900
2,095
Total revenues
1,627,820
1,413,265
6,205,683
4,162,821
Costs and expenses:
Cost of sales
203,101
185,012
736,300
547,758
Research and development expenses
466,584
480,011
1,829,537
1,754,540
Sales, general and administrative
expenses
211,843
195,277
770,456
658,498
Change in fair value of contingent
consideration
500
1,500
13,100
4,459
Total costs and expenses
882,028
861,800
3,349,393
2,965,255
Income from operations
745,792
551,465
2,856,290
1,197,566
Interest income
2,320
12,359
22,239
63,678
Interest expense
(16,288
)
(14,249
)
(58,151
)
(58,502
)
Other income, net (4)
156,799
127,375
296,420
192,177
Income before provision for income
taxes
888,623
676,950
3,116,798
1,394,919
Provision for income taxes
284,433
93,716
405,151
218,109
Net income
$
604,190
$
583,234
$
2,711,647
$
1,176,810
Net income per common share:
Basic
$
2.32
$
2.26
$
10.44
$
4.58
Diluted
$
2.30
$
2.23
$
10.29
$
4.51
Shares used in per share calculations:
Basic
260,038
258,003
259,841
256,728
Diluted
263,106
262,108
263,396
260,673
Reconciliation of GAAP to
Non-GAAP Net Income
Fourth-Quarter Results
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
GAAP net income
$
604,190
$
583,234
$
2,711,647
$
1,176,810
Stock-based compensation expense
97,027
91,591
429,461
360,489
ORKAMBI Adjustment (1)
—
(140,854
)
—
(140,854
)
Increase in fair value of strategic
investments (4)
(171,071
)
(128,734
)
(311,937
)
(197,596
)
Increase in fair value of contingent
consideration (5)
500
1,500
13,100
4,459
Collaborative revenues and expenses
(6)
40,400
56,057
181,700
318,343
Acquisition-related costs (7)
2,820
33,181
10,682
45,871
Total non-GAAP adjustments to pre-tax
income
(30,324
)
(87,259
)
323,006
390,712
Tax adjustments (2)
86,728
(51,627
)
(315,455
)
(178,578
)
Non-GAAP net income
$
660,594
$
444,348
$
2,719,198
$
1,388,944
Net income per diluted common share:
GAAP
$
2.30
$
2.23
$
10.29
$
4.51
Non-GAAP
$
2.51
$
1.70
$
10.32
$
5.33
Shares used in diluted per share
calculations:
GAAP and Non-GAAP
263,106
262,108
263,396
260,673
Reconciliation of GAAP to
Non-GAAP Revenues and Expenses
Fourth-Quarter Results
(in thousands)
(unaudited)
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
GAAP total revenues
$
1,627,820
$
1,413,265
$
6,205,683
$
4,162,821
ORKAMBI Adjustment (1)
—
(155,773
)
—
(155,773
)
Collaborative revenues
(900
)
—
(2,900
)
(158
)
Non-GAAP total revenues
$
1,626,920
$
1,257,492
$
6,202,783
$
4,006,890
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
GAAP cost of sales
$
203,101
$
185,012
$
736,300
$
547,758
ORKAMBI Adjustment (1)
—
(14,919
)
—
(14,919
)
Stock-based compensation expense
(1,581
)
(1,397
)
(5,579
)
(5,575
)
Non-GAAP cost of sales
$
201,520
$
168,696
$
730,721
$
527,264
GAAP research and development
expenses
$
466,584
$
480,011
$
1,829,537
$
1,754,540
Stock-based compensation expense
(58,958
)
(56,707
)
(262,690
)
(224,558
)
Collaborative expenses (6)
(41,300
)
(56,057
)
(184,600
)
(318,501
)
Acquisition-related costs (7)
(2,820
)
(30,461
)
(10,229
)
(40,583
)
Non-GAAP research and development
expenses
$
363,506
$
336,786
$
1,372,018
$
1,170,898
GAAP sales, general and administrative
expenses
$
211,843
$
195,277
$
770,456
$
658,498
Stock-based compensation expense
(36,488
)
(33,487
)
(161,192
)
(130,356
)
Acquisition-related costs (7)
—
(2,720
)
(453
)
(5,288
)
Non-GAAP sales, general and
administrative expenses
$
175,355
$
159,070
$
608,811
$
522,854
Combined non-GAAP R&D and SG&A
expenses
$
538,861
$
495,856
$
1,980,829
$
1,693,752
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
GAAP other income, net
$
156,799
$
127,375
$
296,420
$
192,177
Increase in fair value of strategic
investments (4)
(171,071
)
(128,734
)
(311,937
)
(197,596
)
Non-GAAP other expense, net
$
(14,272
)
$
(1,359
)
$
(15,517
)
$
(5,419
)
GAAP provision for income taxes
$
284,433
$
93,716
$
405,151
$
218,109
Tax adjustments (2)
(86,728
)
51,627
315,455
178,578
Non-GAAP provision for income taxes
(8)
$
197,705
$
145,343
$
720,606
$
396,687
Condensed Consolidated Balance
Sheets
(in thousands)
(unaudited)
December 31, 2020
December 31, 2019
Assets
Cash, cash equivalents and marketable
securities
$
6,658,897
$
3,808,294
Accounts receivable, net
885,352
633,518
Inventories
280,777
167,502
Property and equipment, net
958,534
745,080
Goodwill and intangible assets
1,402,158
1,402,158
Deferred tax assets
882,779
1,190,815
Other assets
683,311
371,098
Total assets
$
11,751,808
$
8,318,465
Liabilities and Shareholders'
Equity
Accounts payable and accrued expenses
$
1,560,110
$
1,204,522
Finance lease liabilities
581,476
577,371
Contingent consideration
189,600
176,500
Other liabilities
733,807
274,828
Shareholders' equity
8,686,815
6,085,244
Total liabilities and shareholders'
equity
$
11,751,808
$
8,318,465
Common shares outstanding
259,890
258,993
Supplemental Income Tax
Information
(in thousands, except
percentages)
(unaudited)
Three Months Ended December
31,
Twelve Months Ended December
31,
2020
2019
2020
2019
Components of provision for income
taxes related to:
Cash paid or accrued for income taxes
$
122,975
$
9,185
$
168,322
$
32,138
Benefits from income taxes due to discrete
tax items (2)
10,034
—
(287,565
)
—
Provision for income taxes offset by net
operating losses and credits (8)
151,424
84,531
524,394
185,971
GAAP provision for income taxes
(8)
$
284,433
$
93,716
$
405,151
$
218,109
Cash paid or accrued for income taxes
$
122,975
$
9,185
$
168,322
$
32,138
Adjustments to pre-tax income
(76,694
)
51,627
27,890
178,578
Provision for income taxes offset by net
operating losses and credits (8)
151,424
84,531
524,394
185,971
Non-GAAP provision for income taxes
(8)
$
197,705
$
145,343
$
720,606
$
396,687
Effective tax rate
reconciliation:
GAAP effective tax rate
32
%
14
%
13
%
16
%
Impact of GAAP to Non-GAAP adjustments
(9
)%
11
%
8
%
6
%
Non-GAAP effective tax rate
23
%
25
%
21
%
22
%
Notes and Explanations
1: "ORKAMBI adjustment" in the company's Reconciliation
of GAAP to Non-GAAP Net Income in the three and twelve months ended
December 31, 2019 included an adjustment to net product revenues
and cost of sales related to the conclusion of the early access
program for ORKAMBI in France in the fourth quarter of 2019. The
company had previously recognized a portion of net product revenues
related to ORKAMBI distributed through the early access program in
France. As a result, the company recognized an adjustment to
increase net product revenues by $155.8 million and cost of sales
by $14.9 million, which related to prior period shipments of
ORKAMBI distributed through the early access program in France. The
company excluded the adjustment to net product revenues and cost of
sales from its Non-GAAP measures for the three and twelve months
ended December 31, 2019.
2: In the three and twelve months ended December 31, 2020
and 2019, "Tax adjustments" primarily related to the estimated
income taxes related to non-GAAP adjustments to pre-tax income
including (i) stock-based compensation (including an adjustment for
excess tax benefits related to stock-based compensation), (ii)
increases or decreases in the fair value of the company's strategic
investments and (iii) collaborative payments. In the twelve months
ended December 31, 2020, "Tax adjustments" also included
non-recurring discrete benefits to the company's provision for
income taxes, such as the transfer of intellectual property rights
to the company's U.K. entity, of approximately $287.6 million that
the company excluded from its Non-GAAP measures.
3: The difference between the company’s full-year 2021
combined GAAP R&D and SG&A expenses and combined non-GAAP
R&D and SG&A expenses guidance relates primarily to $430
million to $500 million of stock-based compensation expense and
$200 million to $250 million of R&D expenses related to
existing collaboration agreements. The guidance regarding combined
GAAP R&D and SG&A expenses does not include estimates
associated with any potential future business development
activities.
4: "Other income, net" includes gains related to changes
in the fair value of the company's strategic investments and from
sales of certain investments.
5: During the three and twelve months ended December 31,
2020 and 2019, the increase in the fair value of contingent
consideration relates to potential payments to Exonics
Therapeutics' former equity holders.
6: "Collaborative revenues and expenses" in the three and
twelve months ended December 31, 2020 and 2019 primarily related to
collaborative upfront and milestone payments.
7: "Acquisition-related costs" in the three and twelve
months ended December 31, 2020 and 2019 related to costs associated
with the company's acquisitions of Semma Therapeutics and
Exonics.
8: The company records a provision for income taxes on
its pre-tax income using an effective tax rate approximating
statutory rates. Since the company released its valuation allowance
on the majority of its net operating losses and other deferred tax
assets as of December 31, 2018, its tax provision has included a
significant non-cash charge due to the company's ability to offset
its pre-tax income against previously benefited net operating
losses and credits. As of December 31, 2019, the company had
federal net operating losses and credits that were available to
offset future pre-tax income. The company utilized substantially
all of its remaining federal net operating losses in 2020. As a
result, a larger portion of the company’s tax provision will
represent a cash expense in future periods, subject to continued
utilization of certain tax credits.
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 diseases. In addition, Vertex has a rapidly
expanding pipeline of genetic and cell 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 11 consecutive years on Science magazine's Top
Employers list and a best place to work for LGBTQ equality by the
Human Rights Campaign. 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,
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 2021
Financial Guidance" and statements regarding (i) anticipated
regulatory filings and data submissions, (ii) anticipated future
label expansions, (iii) the expectations, development plans and
anticipated timelines for the company's medicines, drug candidates
and pipeline programs, including collaborations with third parties,
(iv) expectations for the collaborations with CRISPR, including
expectations regarding completion of enrollment, (v) expectations
for uptake of and expanded access to the company’s medicines,
including additional reimbursement agreements, and (vi) anticipated
investment in internal and external innovation. 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 2021 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 COVID-19 may have different or more significant
impacts on the company's business or operations than the company
currently expects, data from preclinical testing or early clinical
trials, especially if based on a limited number of patients, may
not be indicative of final results, that the FDA may not approve
VX-880 on a timely basis, or at all, 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 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. 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 today at
4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.)
or +1 (720) 545-0001 (International). 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 under
"Events and Presentations." To ensure a timely connection, it is
recommended that users register at least 15 minutes prior to the
scheduled webcast. An archived webcast will be available on the
company's website.
(VRTX-E)
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version on businesswire.com: https://www.businesswire.com/news/home/20210201005809/en/
Vertex Contacts: Investors: Michael Partridge,
617-341-6108 or Zach Barber, 617-341-6470 or Brenda Eustace,
617-341-6187 or Manisha Pai, 617-429-6891
Media: 617-341-6992 mediainfo@vrtx.com
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