MADISON, Wis., May 4, 2021 /PRNewswire/ -- Exact Sciences Corp.
(Nasdaq: EXAS) today announced that the company generated revenue
of $402.1 million for the first
quarter ended March 31, 2021, compared to $347.8 million for the same period of 2020.
"The first quarter demonstrated Exact Sciences is
well-positioned for growth today and into the future," said
Kevin Conroy, Chairman and CEO. "Our
Cologuard® and Oncotype® tests help
people in need of answers, including those who have been vulnerable
during the pandemic. We plan to bring additional solutions to
patients throughout the course of their diagnosis and
treatment."
First Quarter 2021 Financial Results
For the three-month period ended March 31, 2021, as
compared to the same period of 2020 (where applicable):
- Total revenue was $402.1 million,
an increase of 16 percent
- Screening revenue was $240.3
million, an increase of 10 percent
- Precision Oncology revenue was $129.4
million, an increase of 1 percent
- COVID-19 testing revenue was $32.3
million
- Gross margin including amortization of acquired intangible
assets was 68%, and non-GAAP gross margin excluding amortization of
acquired intangible assets was 73%
- Income tax benefit was $242.8
million due to a change in the deferred tax asset valuation
allowance resulting from the Thrive combination
- Net loss was $31.2 million, or
$0.18 per share, compared to a net
loss of $134.6 million, or
$0.91 per share
- EBITDA was $(225.7) million and
adjusted EBITDA was $(23.5)
million
- Cash, cash equivalents, and marketable securities were
$1.38 billion at the end of the
quarter
Screening includes laboratory service revenue from Cologuard
tests and revenue from Biomatrica products. Precision Oncology
includes laboratory service revenue from global Oncotype
products.
2021 Outlook
- The company anticipates revenue of $1,690-$1,735
million during 2021, including Screening revenue of
$1,125-$1,150
million, Precision Oncology revenue of $515-$525 million,
and COVID-19 testing revenue of $50-$60
million.
The company's guidance for revenue is a forward-looking
statement. It is subject to various risks and uncertainties that
could cause the company's actual results to differ materially from
the anticipated targets. There can be no assurance that the company
will meet these financial projections. See the cautionary
information about forward-looking statements in the
"Forward-Looking Statements" section of this news release.
Non-GAAP Disclosure
In addition to the company's
financial results determined in accordance with U.S. GAAP, the
company provides non-GAAP measures that it determines to be useful
in evaluating its operating performance. The company presents
EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and
non-GAAP gross profit. EBITDA and adjusted EBITDA consist of
net loss after adjustment for those items shown in the table below.
The company defines non-GAAP gross profit and non-GAAP gross margin
as GAAP gross profit and GAAP gross margin, respectively, excluding
amortization of acquired intangible assets. The amortization of
acquisition-related intangible assets used in the calculation of
non-GAAP gross profit and non-GAAP gross margin pertain only to the
amortization associated with developed technology acquired and
recorded through purchase accounting transactions. The amortization
of these intangible assets will recur in future periods until such
intangible assets have been fully amortized. The company believes
that these non-GAAP measures are useful in evaluating the company's
operating performance. The company uses this non-GAAP financial
information to evaluate ongoing operations and for internal
planning and forecasting purposes. Non-GAAP financial information,
when taken collectively, may be helpful to investors because it
provides consistency and comparability with past financial
performance. However, non-GAAP financial information is presented
for supplemental information purposes only, has limitations as an
analytical tool and should not be considered in isolation or as a
substitute for financial information presented in accordance with
U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross
profit exclude the amortization of acquired intangible assets
although such measures include the revenue associated with the
acquisitions. For a reconciliation of these non-GAAP measures to
GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and
"Non-GAAP Gross Profit and Non-GAAP Gross Margin
Reconciliations."
First Quarter Conference Call & Webcast
Company
management will host a conference call and webcast on Tuesday,
May 4, 2021, at 5 p.m. ET to
discuss first quarter 2021 results. The webcast will be available
at www.exactsciences.com. Domestic callers should dial 833-235-7650
and international callers should dial +1-647-689-4171. The access
code for both domestic and international callers is 5789488.
An archive of the webcast will be available at
www.exactsciences.com. A replay of the conference call will be
available by calling 800-585-8367 domestically or +1-416-621-4642
internationally. The access code for the replay of the call is
5789488. The webcast, conference call and replay are open to all
interested parties.
About Cologuard
The Cologuard test was approved by the
FDA in August 2014, and results from Exact Sciences'
prospective 90-site, point-in-time, 10,000-patient pivotal trial
were published in the New England Journal of Medicine in
March 2014. The Cologuard test is included in the
American Cancer Society's (2018) colorectal cancer screening
guidelines and the recommendations of the U.S. Preventive Services
Task Force (2016) and National Comprehensive Cancer Network (2016).
The Cologuard test is indicated to screen adults 45 years of age
and older who are at average risk for colorectal cancer by
detecting certain DNA markers and blood in the stool. Do not use
the Cologuard test if you have had precancer, have inflammatory
bowel disease and certain hereditary syndromes, or have a personal
or family history of colorectal cancer. The Cologuard test is not a
replacement for colonoscopy in high risk patients. The Cologuard
test performance in adults ages 45-49 is estimated based on a large
clinical study of patients 50 and older. Cologuard performance in
repeat testing has not been evaluated. The Cologuard test result
should be interpreted with caution. A positive test result does not
confirm the presence of cancer. Patients with a positive test
result should be referred for diagnostic colonoscopy. A negative
test result does not confirm the absence of cancer. Patients with a
negative test result should discuss with their doctor when they
need to be tested again. Medicare and most major insurers cover the
Cologuard test. For more information about the Cologuard test,
visit www.cologuardtest.com.
About Oncotype DX
The Oncotype DX®
portfolio of breast, colon and prostate cancer tests applies
advanced genomic science to reveal the unique biology of a tumor in
order to optimize cancer treatment decisions. In breast cancer, the
Oncotype DX Breast Recurrence Score® test is the only test that has
been shown to predict the likelihood of chemotherapy benefit as
well as recurrence in invasive breast cancer. Additionally, the
Oncotype DX Breast DCIS Score® test predicts the
likelihood of recurrence in a pre-invasive form of breast cancer
called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate
Score® test predicts disease aggressiveness and further
clarifies the current and future risk of the cancer prior to
treatment intervention, and the Oncotype DX AR-V7 Nucleus
Detect® test helps determine which patients with
metastatic castration-resistant prostate cancer (mCRPC) are
resistant to androgen receptor (AR)-targeted therapies. The
Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences
at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact
Sciences. The Oncotype MAP® Pan-Cancer Tissue test is a
rapid, comprehensive tumor profiling panel that aids therapy
selection for patients with advanced, metastatic, refractory, or
recurrent cancer. With more than 1 million patients tested in more
than 90 countries, the Oncotype tests have redefined personalized
medicine by making genomics a critical part of cancer diagnosis and
treatment. To learn more about Oncotype tests, visit
www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or
www.MyProstateCancerTreatment.org.
About Exact Sciences Corp.
A leading provider of
cancer screening and diagnostic tests, Exact Sciences relentlessly
pursues smarter solutions providing the clarity to take
life-changing action, earlier. Building on the success of Cologuard
and Oncotype tests, Exact Sciences is investing in its product
pipeline to take on some of the deadliest cancers and improve
patient care. Exact Sciences unites visionary collaborators to help
advance the fight against cancer. For more information, please
visit the company's website at www.exactsciences.com, follow Exact
Sciences on Twitter @ExactSciences, or find Exact Sciences on
Facebook.
Forward-Looking Statements
This news release contains
forward-looking statements concerning our expectations,
anticipations, intentions, beliefs or strategies regarding the
future. These forward-looking statements are based on assumptions
that we have made as of the date hereof and are subject to known
and unknown risks and uncertainties that could cause actual
results, conditions and events to differ materially from those
anticipated. Therefore, you should not place undue reliance on
forward-looking statements. Examples of forward-looking statements
include, among others, statements we make regarding expected future
operating results; our strategies, positioning, resources,
capabilities and expectations for future events or performance; and
the anticipated benefits of our acquisitions, including estimated
synergies and other financial impacts.
Important factors that could cause actual results, conditions
and events to differ materially from those indicated in the
forward-looking statements include, among others, the following:
uncertainties associated with the coronavirus (COVID-19) pandemic,
including its possible effects on our operations, including our
supply chain and clinical studies, and the demand for our cancer
and COVID-19 testing products and services; our ability to
efficiently and flexibly manage our business amid uncertainties
related to COVID-19; our ability to successfully and profitably
market our products and services; the acceptance of our products
and services by patients and healthcare providers; our ability to
meet demand for our products and services; the willingness of
health insurance companies and other payers to cover our products
and services and adequately reimburse us for such products and
services; the amount and nature of competition for our products and
services; the effects of any judicial, executive or legislative
action affecting us or the healthcare system; recommendations,
guidelines and quality metrics issued by various organizations
regarding cancer screening or our products and services; our
ability to successfully develop new products and services and
assess potential market opportunities; our ability to effectively
enter into and utilize strategic partnerships and acquisitions; our
success establishing and maintaining collaborative, licensing and
supplier arrangements; our ability to maintain regulatory approvals
and comply with applicable regulations; our ability to manage an
international business and our expectations regarding our
international expansion and opportunities; the potential effects of
foreign currency exchange rate fluctuations and our efforts to
hedge such effects; the possibility that the anticipated benefits
from our business acquisitions will not be realized in full or at
all or may take longer to realize than expected; the possibility
that costs or difficulties related to the integration of acquired
businesses' operations will be greater than expected and the
possibility that integration efforts will disrupt our business and
strain management time and resources; the outcome of any
litigation, government investigations, enforcement actions or other
legal proceedings, including in connection with acquisitions; our
ability to retain and hire key personnel including employees at
businesses we acquire. The risks included above are not exhaustive.
Other important risks and uncertainties are described in the Risk
Factors sections of our most recent Annual Report on Form 10-K and
any subsequent Quarterly Reports on Form 10-Q, and in our other
reports filed with the Securities and Exchange Commission. We
undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
EXACT SCIENCES
CORPORATION
Selected Unaudited
Financial Information
Condensed
Consolidated Statements of Operations
(Amounts in
thousands, except per share data)
|
|
|
Three Months Ended
March 31,
|
|
2021
|
|
2020
|
Revenue
|
$
|
402,077
|
|
|
$
|
347,821
|
|
|
|
|
|
Operating
expenses
|
|
|
|
Cost of sales
(exclusive of amortization of acquired intangible
assets)
|
109,993
|
|
|
81,606
|
|
Research and
development
|
115,567
|
|
|
43,509
|
|
Sales and
marketing
|
186,141
|
|
|
167,749
|
|
General and
administrative
|
267,727
|
|
|
113,991
|
|
Amortization of
acquired intangible assets
|
23,190
|
|
|
23,339
|
|
Total operating
expenses
|
702,618
|
|
|
430,194
|
|
Loss from
operations
|
(300,541)
|
|
|
(82,373)
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
Investment income,
net
|
31,188
|
|
|
97
|
|
Interest
expense
|
(4,616)
|
|
|
(54,604)
|
|
Total other income
(expense)
|
26,572
|
|
|
(54,507)
|
|
|
|
|
|
Net loss before
tax
|
(273,969)
|
|
|
(136,880)
|
|
|
|
|
|
Income tax
benefit
|
242,805
|
|
|
2,237
|
|
|
|
|
|
Net loss
|
$
|
(31,164)
|
|
|
$
|
(134,643)
|
|
|
|
|
|
Net loss per
share—basic and diluted
|
$
|
(0.18)
|
|
|
$
|
(0.91)
|
|
|
|
|
|
Weighted average
common shares outstanding—basic and diluted
|
169,434
|
|
|
148,151
|
|
EXACT SCIENCES
CORPORATION
Selected Unaudited
Financial Information
Condensed
Consolidated Balance Sheets
(Amounts in
thousands)
|
|
|
March 31,
2021
|
|
December 31,
2020
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
|
1,103,816
|
|
|
$
|
1,491,288
|
|
Marketable
securities
|
274,151
|
|
|
348,699
|
|
Accounts receivable,
net
|
256,135
|
|
|
233,185
|
|
Inventory,
net
|
89,033
|
|
|
92,265
|
|
Prepaid expenses and
other current assets
|
52,167
|
|
|
33,157
|
|
Property, plant and
equipment, net
|
482,736
|
|
|
451,986
|
|
Operating lease
right-of-use assets
|
161,687
|
|
|
125,947
|
|
Goodwill
|
2,183,915
|
|
|
1,237,672
|
|
Intangible assets,
net
|
2,073,932
|
|
|
847,123
|
|
Other long-term
assets, net
|
56,945
|
|
|
63,770
|
|
Total
assets
|
$
|
6,734,517
|
|
|
$
|
4,925,092
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Convertible notes,
net, current portion
|
$
|
312,832
|
|
|
$
|
312,716
|
|
Current
liabilities
|
316,082
|
|
|
320,380
|
|
Convertible notes,
net, less current portion
|
1,862,992
|
|
|
1,861,685
|
|
Long-term debt, less
current portion
|
22,041
|
|
|
22,342
|
|
Other long-term
liabilities
|
414,195
|
|
|
51,342
|
|
Operating lease
liabilities, less current portion
|
157,380
|
|
|
121,075
|
|
Total stockholders'
equity
|
3,648,995
|
|
|
2,235,552
|
|
Total liabilities and
stockholders' equity
|
$
|
6,734,517
|
|
|
$
|
4,925,092
|
|
EXACT SCIENCES
CORPORATION
Selected Unaudited
Financial Information
EBITDA and
Adjusted EBITDA Reconciliations
(Amounts in
thousands)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2021
|
|
2020
|
Net loss
|
|
$
|
(31,164)
|
|
|
$
|
(134,643)
|
|
Interest
expense
|
|
4,616
|
|
|
3,785
|
|
Depreciation and
amortization
|
|
43,698
|
|
|
39,345
|
|
Income tax
benefit
|
|
(242,805)
|
|
|
(2,237)
|
|
EBITDA
|
|
$
|
(225,655)
|
|
|
$
|
(93,750)
|
|
Investment
income
|
|
(31,188)
|
|
|
(97)
|
|
Stock-based
compensation
|
|
63,068
|
|
|
26,742
|
|
Loss on settlement of
convertible notes (1)
|
|
—
|
|
|
50,819
|
|
Acquisition and
integration costs (2)
|
|
118,014
|
|
|
8,048
|
|
Asset acquisition
(3)
|
|
52,263
|
|
|
—
|
|
Adjusted
EBITDA
|
|
$
|
(23,498)
|
|
|
$
|
(8,238)
|
|
|
|
|
|
|
(1) The loss on
settlement of convertible notes represents the difference between
(i) the fair value of the consideration transferred and (ii) the
sum of the carrying value of the debt at the time of repurchase for
$100 million of convertible notes with an original maturity of
January 15, 2025.
|
|
(2) Represents
acquisition and related integration costs incurred as a result of
the Company's business combinations and asset acquisitions, a
majority of which relates to the acquisition of Thrive Earlier
Detection Corp. ("Thrive") for the three months ended
March 31, 2021. Incremental stock-based compensation including
the fair value of assumed stock awards was $100.4 million and $2.8
million for the three months ended March 31, 2021 and 2020,
respectively. Legal and other professional service fees were $14.7
million and $5.2 million for the three months ended March 31,
2021 and 2020, respectively. Expense of $2.9 million was incurred
for the three months ended March 31, 2021 resulting from the
remeasurement of the contingent consideration liabilities in
connection with business combinations.
|
|
(3) During the first
quarter of 2021, the Company acquired a worldwide exclusive license
to the proprietary Targeted Digital Sequencing ("TARDIS")
technology from The Translational Genomics Research Institute
("TGen"). The acquisition was treated as an asset acquisition under
U.S. GAAP and resulted in a $52.3 million charge to research and
development expense.
|
EXACT SCIENCES
CORPORATION
Selected Unaudited
Financial Information
Non-GAAP Gross
Profit and Non-GAAP Gross Margin Reconciliations
(Amounts in
thousands)
|
|
|
|
Three Months Ended
March 31,
|
|
|
2021
|
|
2020
|
Revenue
|
|
$
|
402,077
|
|
$
|
347,821
|
Cost of sales
(exclusive of amortization of acquired intangible
assets)
|
|
109,993
|
|
81,606
|
Amortization of
acquired intangible assets (1)
|
|
20,555
|
|
20,464
|
Gross
profit
|
|
$
|
271,529
|
|
$
|
245,751
|
Gross
margin
|
|
68
|
%
|
|
71
|
%
|
|
|
|
|
|
Amortization of
acquired intangible assets (1)
|
|
20,555
|
|
20,464
|
Non-GAAP gross
profit
|
|
$
|
292,084
|
|
$
|
266,215
|
Non-GAAP gross
margin
|
|
73
|
%
|
|
77
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes only
amortization of intangible assets identified as developed
technology assets through purchase accounting transactions, which
otherwise would have been allocated to cost of sales.
|
Investor Contact:
Megan
Jones
Exact Sciences Corp.
meganjones@exactsciences.com
608-535-8815
Media Contact:
Katie
Boyce
Exact Sciences Corp.
kboyce@exactsciences.com
608-710-3903
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SOURCE EXACT SCIENCES CORP