MADISON, Wis., July 28, 2021 /PRNewswire/ -- Exact Sciences
Corp. (Nasdaq: EXAS) today announced that the company generated
revenue of $434.8 million for the
second quarter ended June 30, 2021, compared to $268.9 million for the same period of 2020.
"The Exact Sciences team remained unwavering in their dedication
to our mission and delivered record results for
Cologuard® and Oncotype DX®," said
Kevin Conroy, chairman and CEO. "We
have a strong foundation in cancer screening and precision oncology
and plan to transform cancer care with Cologuard, Oncotype, and our
deep pipeline of innovative tests."
Second Quarter 2021 Financial Results
For the three-month period ended June 30, 2021, as
compared to the same period of 2020 (where applicable):
- Total revenue was $434.8 million,
an increase of 62 percent
- Screening revenue was $263.9
million, an increase of 101 percent
- Screening revenue included a one-time downward adjustment of
$12.1 million related to the passing
of the contractual deadline to submit claims for previously
completed Cologuard tests
- Precision Oncology revenue was $137.8
million, an increase of 34 percent
- COVID-19 testing revenue was $33.1
million, a decrease of 4 percent
- Gross margin including amortization of acquired intangible
assets was 69%, and non-GAAP gross margin excluding amortization of
acquired intangible assets was 74%
- Net loss was $176.9 million, or
$1.03 per share, compared to a net
loss of $68.1 million, or
$0.45 per share
- EBITDA was $(122.9) million and
adjusted EBITDA was $(26.5)
million
- Cash, cash equivalents, and marketable securities were
$1.31 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
and laboratory service revenue from Ashion.
2021 Outlook
- The company anticipates revenue of $1,705-$1,745
million, including Screening revenue of $1,100-$1,125
million, Precision Oncology revenue of $530-$540 million,
and COVID-19 testing revenue of $75-$80
million.
- Updated guidance is an increase from previously expected
revenue of $1,690-$1,735 million, which included Screening revenue
of $1,125-$1,150 million, Precision Oncology revenue of
$515-$525
million, and COVID-19 testing revenue of $50-$60
million.
- Lower Screening revenue expectations are primarily due to the
one-time downward revenue adjustment of $12.1 million referenced above and COVID-19
dynamics negatively impacting the business, including reduced
physician office access for our field sales teams and fewer patient
wellness visits.
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."
Second Quarter Conference Call & Webcast
Company management will host a conference call and webcast on
Wednesday, July 28, 2021, at 5 p.m.
ET to discuss second quarter 2021 results. The webcast will
be available at www.exactsciences.com. Domestic callers should dial
833-235-7650 and international callers should dial +1-647-788-4901.
The access code for both domestic and international callers is
3969691.
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
3969691. 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 (2021) 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 support patients throughout
their cancer diagnosis and treatment. 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 obtain and 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.
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
EXACT SCIENCES
CORPORATION Selected Unaudited Financial
Information
Condensed Consolidated Statements of Operations
(Amounts in thousands, except per share data)
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenue
|
$
|
434,819
|
|
|
$
|
268,868
|
|
|
$
|
836,896
|
|
|
$
|
616,689
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
Cost of sales
(exclusive of amortization of acquired intangible
assets)
|
113,968
|
|
|
77,892
|
|
|
223,961
|
|
|
159,498
|
|
Research and
development
|
106,235
|
|
|
32,673
|
|
|
221,802
|
|
|
76,182
|
|
Sales and
marketing
|
194,827
|
|
|
118,862
|
|
|
380,968
|
|
|
286,611
|
|
General and
administrative
|
167,629
|
|
|
106,685
|
|
|
435,356
|
|
|
220,676
|
|
Amortization of
acquired intangible assets
|
23,824
|
|
|
23,430
|
|
|
47,014
|
|
|
46,769
|
|
Total operating
expenses
|
606,483
|
|
|
359,542
|
|
|
1,309,101
|
|
|
789,736
|
|
|
|
|
|
|
|
|
|
Other operating
income
|
—
|
|
|
23,665
|
|
|
—
|
|
|
23,665
|
|
Loss from
operations
|
(171,664)
|
|
|
(67,009)
|
|
|
(472,205)
|
|
|
(149,382)
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
Investment income,
net
|
3,429
|
|
|
2,912
|
|
|
34,617
|
|
|
3,009
|
|
Interest
expense
|
(4,652)
|
|
|
(4,300)
|
|
|
(9,268)
|
|
|
(58,904)
|
|
Total other income
(expense)
|
(1,223)
|
|
|
(1,388)
|
|
|
25,349
|
|
|
(55,895)
|
|
|
|
|
|
|
|
|
|
Net loss before
tax
|
(172,887)
|
|
|
(68,397)
|
|
|
(446,856)
|
|
|
(205,277)
|
|
|
|
|
|
|
|
|
|
Income tax benefit
(expense)
|
(4,025)
|
|
|
305
|
|
|
238,780
|
|
|
2,542
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(176,912)
|
|
|
$
|
(68,092)
|
|
|
$
|
(208,076)
|
|
|
$
|
(202,735)
|
|
|
|
|
|
|
|
|
|
Net loss per
share—basic and diluted
|
$
|
(1.03)
|
|
|
$
|
(0.45)
|
|
|
$
|
(1.22)
|
|
|
$
|
(1.36)
|
|
|
Weighted average
common shares outstanding—basic and diluted
|
|
171,494
|
|
|
|
149,727
|
|
|
|
170,469
|
|
|
|
148,938
|
|
EXACT SCIENCES
CORPORATION
Selected Unaudited Financial Information
Condensed Consolidated Balance Sheets
(Amounts in thousands)
|
|
|
June 30,
2021
|
|
December 31,
2020
|
Assets
|
|
|
|
Cash and cash
equivalents
|
$
|
363,715
|
|
|
$
|
1,491,288
|
|
Marketable
securities
|
943,864
|
|
|
348,699
|
|
Accounts receivable,
net
|
226,539
|
|
|
233,185
|
|
Inventory
|
89,809
|
|
|
92,265
|
|
Prepaid expenses and
other current assets
|
45,284
|
|
|
33,157
|
|
Property, plant and
equipment, net
|
501,908
|
|
|
451,986
|
|
Operating lease
right-of-use assets
|
166,914
|
|
|
125,947
|
|
Goodwill
|
2,242,535
|
|
|
1,237,672
|
|
Intangible assets,
net
|
2,089,108
|
|
|
847,123
|
|
Other long-term
assets, net
|
54,658
|
|
|
63,770
|
|
Total
assets
|
$
|
6,724,334
|
|
|
$
|
4,925,092
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Convertible notes,
net, current portion
|
$
|
312,961
|
|
|
$
|
312,716
|
|
Current
liabilities
|
362,737
|
|
|
320,380
|
|
Convertible notes,
net, less current portion
|
1,864,312
|
|
|
1,861,685
|
|
Long-term debt, less
current portion
|
21,740
|
|
|
22,342
|
|
Other long-term
liabilities
|
439,175
|
|
|
51,342
|
|
Operating lease
liabilities, less current portion
|
164,308
|
|
|
121,075
|
|
Total stockholders'
equity
|
3,559,101
|
|
|
2,235,552
|
|
Total liabilities and
stockholders' equity
|
$
|
6,724,334
|
|
|
$
|
4,925,092
|
|
EXACT SCIENCES
CORPORATION
Selected Unaudited Financial Information
EBITDA and Adjusted EBITDA Reconciliations
(Amounts in thousands)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
(In
thousands)
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Net income
(loss)
|
|
$
|
(176,912)
|
|
|
$
|
(68,092)
|
|
|
$
|
(208,076)
|
|
|
$
|
(202,735)
|
|
Interest
expense
|
|
4,652
|
|
|
4,300
|
|
|
9,268
|
|
|
8,085
|
|
Depreciation and
amortization
|
|
45,323
|
|
|
41,056
|
|
|
89,021
|
|
|
80,401
|
|
Income tax expense
(benefit)
|
|
4,025
|
|
|
(305)
|
|
|
(238,780)
|
|
|
(2,542)
|
|
EBITDA
|
|
$
|
(122,912)
|
|
|
$
|
(23,041)
|
|
|
$
|
(348,567)
|
|
|
$
|
(116,791)
|
|
Stock-based
compensation
|
|
53,895
|
|
|
38,780
|
|
|
116,963
|
|
|
65,522
|
|
Investment
income
|
|
(3,429)
|
|
|
(2,912)
|
|
|
(34,617)
|
|
|
(3,009)
|
|
Acquisition and
integration costs (1)
|
|
12,857
|
|
|
3,719
|
|
|
131,251
|
|
|
11,768
|
|
Asset acquisition
(2)
|
|
33,074
|
|
|
—
|
|
|
85,337
|
|
|
—
|
|
Loss on settlement of
convertible notes (3)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
50,819
|
|
CARES Act Funding
(4)
|
|
—
|
|
|
(23,665)
|
|
|
—
|
|
|
(23,665)
|
|
Reduction-in-force
severance (5)
|
|
—
|
|
|
2,198
|
|
|
—
|
|
|
2,198
|
|
Adjusted
EBITDA
|
|
$
|
(26,515)
|
|
|
$
|
(4,921)
|
|
|
$
|
(49,633)
|
|
|
$
|
(13,158)
|
|
|
|
|
|
(1) 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 and six months ended
June 30, 2021. Incremental stock-based compensation including
the fair value of assumed stock awards was $2.4 million and $102.8
million for the three and six months ended June 30, 2021,
respectively. Incremental stock-based compensation including the
fair value of assumed stock awards was $1.3 million and $4.1
million for the three and six months ended June 30, 2020. Legal and
other professional service fees were $4.1 million and $19.3 million
for the three and six months ended June 30, 2021,
respectively. Legal and other professional service fees were $2.4
million and $7.7 million for the three and six months ended June
30, 2020, respectively. Expense of $6.3 million and $9.2 million
was incurred for the three and six months ended June 30, 2021
resulting from the remeasurement of the contingent consideration
liabilities in connection with business combinations.
|
|
(2) 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. During the second quarter of 2021, the Company
acquired PFS Genomics, Inc. The acquisition was treated as an asset
acquisition under U.S. GAAP and resulted in a $33.1 million charge
to research and development expense.
|
|
(3) 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.
|
|
(4) As part of the
Coronavirus Aid, Relief, and Economic Security Act ("CARES Act"),
the Company received $23.7 million from the United States
Department of Health and Human Services Provider Relief Fund
provided to eligible healthcare providers. The CARES Act funds are
meant to offset the implications of the COVID-19 pandemic which
include increases in the Company's costs and lost
revenues.
|
|
(5) Represents
severance costs as a result of proactive measures the Company put
in place to address the impact of the COVID-19 pandemic. The
severance cost resulting from this workforce reduction was $2.2
million for the three months and six months ended June 30,
2020.
|
EXACT SCIENCES
CORPORATION
Selected Unaudited Financial Information
Non-GAAP Gross Profit and Non-GAAP Gross Margin
Reconciliations
(Amounts in thousands)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenue
|
|
$
|
434,819
|
|
$
|
268,868
|
|
$
|
836,896
|
|
$
|
616,689
|
Cost of sales
(exclusive of amortization of acquired intangible
assets)
|
|
113,968
|
|
77,892
|
|
223,961
|
|
159,498
|
Amortization of
acquired intangible assets (1)
|
|
21,188
|
|
20,555
|
|
41,742
|
|
41,018
|
Gross
profit
|
|
$
|
299,663
|
|
$
|
170,421
|
|
$
|
571,193
|
|
$
|
416,173
|
Gross
margin
|
|
69%
|
|
63%
|
|
68%
|
|
67%
|
|
|
|
|
|
|
|
|
|
Amortization of
acquired intangible assets (1)
|
|
21,188
|
|
20,555
|
|
41,742
|
|
41,018
|
Non-GAAP gross
profit
|
|
$
|
320,851
|
|
$
|
190,976
|
|
$
|
612,935
|
|
$
|
457,191
|
Non-GAAP gross
margin
|
|
74%
|
|
71%
|
|
73%
|
|
74%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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.
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/exact-sciences-announces-second-quarter-2021-results-301343360.html
SOURCE EXACT SCIENCES CORP