0001124140-20-000050.txt : 20200730 0001124140-20-000050.hdr.sgml : 20200730 20200730184624 ACCESSION NUMBER: 0001124140-20-000050 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20200730 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200730 DATE AS OF CHANGE: 20200730 FILER: COMPANY DATA: COMPANY CONFORMED NAME: EXACT SCIENCES CORP CENTRAL INDEX KEY: 0001124140 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 204782291 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35092 FILM NUMBER: 201061447 BUSINESS ADDRESS: STREET 1: 441 CHARMANY DRIVE CITY: MADISON STATE: WI ZIP: 53719 BUSINESS PHONE: 608-284-5700 MAIL ADDRESS: STREET 1: 441 CHARMANY DRIVE CITY: MADISON STATE: WI ZIP: 53719 FORMER COMPANY: FORMER CONFORMED NAME: EXACT CORP DATE OF NAME CHANGE: 20000919 8-K 1 exas-20200730x8xk.htm 8-K Document
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  July 30, 2020
 
EXACT SCIENCES CORPORATION
(Exact Name of Registrant as Specified in Charter)
 
DE
 
001-35092
 
02-0478229
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(I.R.S. Employer
Identification No.)
 
5505 Endeavor Lane
Madison, WI  53719
(Address of Principal Executive Offices)(Zip Code)
 
Registrant’s telephone number, including area code:  (608) 284-5700
 
441 Charmany Drive
Madison, WI 53719
(Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
☐            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐           Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐           Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange
on which registered
Common Stock, $0.01 par value per share
 
EXAS
 
NASDAQ
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 




2.02.                     Results of Operations and Financial Conditions.
 
On July 30, 2020, Exact Sciences Corporation announced its financial results for the quarter ended June 30, 2020.  A copy of the press release is being furnished as Exhibit 99 to this Current Report on Form 8-K.

The information in this Current Report on Form 8-K and Exhibit 99 attached hereto is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
 
9.01.                     Financial Statements and Exhibits.
 
Exhibits
 
The exhibits required to be filed as a part of this Current Report on Form 8-K are listed below and incorporated herein by reference.
  
Exhibit No.
 
Exhibit Description
 
 
 
 
Press release, dated July 30, 2020, issued by Exact Sciences Corporation, furnished herewith.
 
 
 
104
 
The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

2



SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
EXACT SCIENCES CORPORATION
 
 
 
Date: July 30, 2020
By:
/s/ Jeffrey T. Elliott
 
 
Jeffrey T. Elliott
 
 
Chief Financial Officer


3
 EX-99 2 exas-20200730xex99.htm EXHIBIT 99 Exhibit


Exhibit 99
 
Investor Contact:
Megan Jones
Exact Sciences Corp.
meganjones@exactsciences.com
608-535-8815
 
Media Contact:
Cara Connelly
Exact Sciences Corp.
cconnelly@exactsciences.com
608-284-5735
 
For Immediate Release
 
Exact Sciences Announces Second Quarter 2020 Results 

 
MADISON, Wis., July 30, 2020 — Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company generated revenue of $268.9 million for the second quarter ended June 30, 2020, compared to $199.9 million for the same period of 2019.
 
"Cologuard helps solve the problem of COVID-related missed cancer screenings because it's a convenient, accurate, at-home test, and we believe this will accelerate adoption," said Kevin Conroy, Chairman and CEO. "COVID-19 is elevating the importance of our Precision Oncology tests, as patients and physicians look for smarter, faster answers to guide their cancer treatment decisions. As diagnostic testing continues to play a larger, more important role in cancer care, Exact Sciences is in a unique position to create value at every step along the way."

Second Quarter 2020 Financial Results

For the three-month period ended June 30, 2020, as compared to the same period of 2019 (where applicable):

•
Total revenue was $268.9 million, compared to $199.9 million
•
Screening revenue was $131.3 million, a decrease of 34 percent
•
Precision Oncology revenue was $103.0 million
•
COVID-19 testing revenue was $34.6 million
•
Gross margin including amortization of acquired intangible assets was 63 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 71 percent
•
Other operating income consisted of a one-time payment of $23.7 million from the Coronavirus Aid, Relief, and Economic Security (CARES) Act Provider Relief Fund
•
Net loss was $86.1 million, or $0.58 per share, compared to a net loss of $38.5 million, or $0.30 per share
•
EBITDA was $(26.0) million and adjusted EBITDA was $(4.9) million
•
Non-cash interest expense related to convertible debt was $20.1 million, compared to $10.7 million
•
Cash, cash equivalents, and marketable securities were $1.2 billion at the end of the quarter

Screening includes laboratory service revenue from Cologuard and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype DX products and the recent Paradigm acquisition. 

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 Thursday, July 30, 2020, at 5 p.m. ET to discuss second quarter 2020 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 8183605.

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 416-621-4642 internationally. The access code for the replay of the call is 8183605. The webcast, conference call and replay are open to all interested parties.
 
About Cologuard
Cologuard 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. Cologuard 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). Cologuard 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 Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard 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 Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

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. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX 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 DX, 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 within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this news release regarding our strategies, prospects, expectations, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement, and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition 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 and the demand for our 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 success of our efforts to facilitate patient access to Cologuard via telehealth; 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 the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Quality Assurance 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, such as through our Promotion Agreement with Pfizer, Inc., 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 cannot 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 will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. 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 June 30,
 
Six Months Ended June 30,
 
2020
 
2019
 
2020
 
2019
Revenue
$
268,868

 
$
199,870

 
$
616,689

 
$
361,913

 
 
 
 
 
 
 
 
Operating expenses
 
 
 
 
 
 
 
Cost of sales (exclusive of amortization of acquired intangible assets)
77,892

 
51,139

 
159,498

 
93,966

Research and development
32,673

 
29,972

 
76,182

 
61,757

Sales and marketing
118,862

 
88,190

 
286,611

 
179,129

General and administrative
106,685

 
63,723

 
220,676

 
127,529

Amortization of acquired intangible assets
23,430

 
748

 
46,769

 
1,508

Total operating expenses
359,542

 
233,772

 
789,736

 
463,889

 
 
 
 
 
 
 
 
Other operating income
23,665

 
—

 
23,665

 
—

Loss from operations
(67,009
)
 
(33,902
)
 
(149,382
)
 
(101,976
)
 
 
 
 
 
 
 
 
Other income (expense)
 
 
 
 
 
 
 
Investment income, net
2,912

 
7,669

 
3,009

 
14,324

Interest expense
(22,912
)
 
(12,712
)
 
(48,065
)
 
(34,702
)
Total other income (expense)
(20,000
)
 
(5,043
)
 
(45,056
)
 
(20,378
)
 
 
 
 
 
 
 
 
Net loss before tax
(87,009
)
 
(38,945
)
 
(194,438
)
 
(122,354
)
 
 
 
 
 
 
 
 
Income tax benefit
867

 
443

 
2,599

 
913

 
 
 
 
 
 
 
 
Net loss
$
(86,142
)
 
$
(38,502
)
 
$
(191,839
)
 
$
(121,441
)
 
 
 
 
 
 
 
 
Net loss per share—basic and diluted
$
(0.58
)
 
$
(0.30
)
 
$
(1.29
)
 
$
(0.95
)
 
 
 
 
 
 
 
 
Weighted average common shares outstanding—basic and diluted
149,727
 
129,182
 
148,938
 
127,723





EXACT SCIENCES CORPORATION
Selected Unaudited Financial Information
Condensed Consolidated Balance Sheets
(Amounts in thousands)

 
June 30, 2020
 
December 31, 2019
Assets
 
 
 
Cash and cash equivalents
$
703,926

 
$
177,254

Marketable securities
518,731

 
146,401

Accounts receivable, net
163,608

 
130,667

Inventory, net
82,215

 
61,724

Prepaid expenses and other current assets
36,378

 
40,913

Property, plant and equipment, net
463,437

 
455,325

Operating lease right-of-use assets
132,751

 
126,444

Goodwill
1,237,672

 
1,203,197

Intangible assets, net
1,105,115

 
1,143,550

Other long-term assets, net
23,902

 
20,293

Total assets
$
4,467,735

 
$
3,505,768

 
 
 
 
Liabilities and stockholders' equity
 
 
 
Total current liabilities
$
222,274

 
$
236,494

Convertible notes, net
1,534,383

 
803,605

Long-term debt, less current portion
22,944

 
24,032

Other long-term liabilities
50,311

 
34,911

Operating lease liabilities, less current portion
126,630

 
118,665

Total stockholders’ equity
2,511,193

 
2,288,061

Total liabilities and stockholders’ equity
$
4,467,735

 
$
3,505,768






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,
 
2020
 
2019
 
2020
 
2019
Net loss
$
(86,142
)
 
$
(38,502
)
 
$
(191,839
)
 
$
(121,441
)
Interest expense
22,912

 
12,712

 
40,111

 
24,144

Investment income
(2,912
)
 
(7,669
)
 
(3,009
)
 
(14,324
)
Depreciation and amortization
41,056

 
7,880

 
80,401

 
15,015

Income tax benefit
(867
)
 
(443
)
 
(2,599
)
 
(913
)
EBITDA
$
(25,953
)
 
$
(26,022
)
 
$
(76,935
)
 
$
(97,519
)
Stock-based compensation
38,780

 
20,143

 
65,522

 
36,309

Loss on settlement of convertible notes
—

 
—

 
7,954

 
10,558

Acquisition and integration costs (1)
3,719

 
—

 
11,768

 
—

Reduction-in-force severance (2)
2,198

 
—

 
2,198

 
—

CARES Act Funding (3)
(23,665
)
 
—

 
(23,665
)
 
—

Adjusted EBITDA
$
(4,921
)
 
$
(5,879
)
 
$
(13,158
)
 
$
(50,652
)
 
(1) Represents acquisition and related integration costs incurred as a result of the company's combination with Genomic Health. Acquisition and integration costs were $3.7 million and $11.8 million for the three months and six months ended June 30, 2020. The costs primarily consist of legal and other professional service fees and incremental stock-based compensation including the fair value of stock awards assumed by the company in connection with the Genomic Health combination. Legal, severance, and other professional service fees were $2.4 million and $7.7 million for the three months and six months ended June 30, 2020. Incremental stock-based compensation including the fair value of assumed stock awards was $1.3 million and $4.1 million for the three months and six months ended June 30, 2020, respectively.

(2) 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.

(3) 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.





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,
 
2020
 
2019
 
2020
 
2019
Revenue
$
268,868

 
$
199,870

 
$
616,689

 
$
361,913

Cost of sales (exclusive of amortization of acquired intangible assets)
77,892

 
51,139

 
159,498

 
93,966

Amortization of acquired intangible assets (1)
20,555

 
424

 
41,018

 
849

Gross profit
$
170,421

 
$
148,307

 
$
416,173

 
$
267,098

Gross margin
63
%
 
74
%
 
67
%
 
74
%
 
 
 
 
 
 
 
 
Amortization of acquired intangible assets (1)
20,555

 
424

 
41,018

 
849

Non-GAAP gross profit
$
190,976

 
$
148,731

 
$
457,191

 
$
267,947

Non-GAAP gross margin
71
%
 
74
%
 
74
%
 
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.


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Entity Address, State or Province WI
Entity Address, Postal Zip Code 53719
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