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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2022
OR
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
Commission File Number: 001-35092
EXACT SCIENCES CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware |
02-0478229 |
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification Number)
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5505 Endeavor Lane, Madison WI
|
53719 |
(Address of principal executive offices) |
(Zip Code) |
(608) 535-8815
(Registrant’s telephone number, including area
code)
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, $0.01 par value per share |
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EXAS |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant: (1) has filed
all reports required to be filed by Section 13 or
15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically, if any, every Interactive Data File required to be
submitted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit such files).
Yes
☒
No
☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in
Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
☒ |
Accelerated filer |
☐ |
Non-accelerated filer |
☐ |
Smaller reporting company |
☐ |
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.
☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
As of August 1, 2022, the registrant had 176,959,543 shares of
common stock outstanding.
EXACT SCIENCES CORPORATION
EXACT SCIENCES CORPORATION
Condensed Consolidated Balance Sheets
(Amounts in thousands, except share data - unaudited)
Part I — Financial Information
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June 30, 2022 |
|
December 31, 2021 |
ASSETS |
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Current Assets: |
|
|
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Cash and cash equivalents |
$ |
213,421 |
|
|
$ |
315,471 |
|
Marketable securities |
514,623 |
|
|
715,005 |
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Accounts receivable, net |
186,542 |
|
|
216,645 |
|
Inventory |
115,172 |
|
|
104,994 |
|
Prepaid expenses and other current assets |
71,875 |
|
|
74,122 |
|
Total current assets |
1,101,633 |
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1,426,237 |
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Long-term Assets: |
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Property, plant and equipment, net |
663,653 |
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580,248 |
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Operating lease right-of-use assets |
182,494 |
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174,225 |
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Goodwill |
2,345,922 |
|
|
2,335,172 |
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Intangible assets, net |
2,046,773 |
|
|
2,094,411 |
|
Other long-term assets, net |
96,680 |
|
|
74,591 |
|
Total assets |
$ |
6,437,155 |
|
|
$ |
6,684,884 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current Liabilities: |
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|
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Accounts payable |
$ |
84,167 |
|
|
$ |
67,829 |
|
Accrued liabilities |
308,219 |
|
|
398,556 |
|
Operating lease liabilities, current portion |
25,813 |
|
|
19,710 |
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Other current liabilities |
25,132 |
|
|
30,973 |
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Total current liabilities |
443,331 |
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|
517,068 |
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Long-term Liabilities: |
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Convertible notes, net |
2,183,145 |
|
|
2,180,232 |
|
Long-term debt |
50,000 |
|
|
— |
|
Other long-term liabilities |
364,107 |
|
|
417,782 |
|
Operating lease liabilities, less current portion |
187,226 |
|
|
182,166 |
|
Total liabilities |
3,227,809 |
|
|
3,297,248 |
|
Commitments and contingencies (Note 14) |
|
|
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Stockholders’ Equity: |
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|
|
Preferred stock, $0.01 par value Authorized—5,000,000 shares issued
and outstanding—no shares at June 30, 2022 and
December 31, 2021
|
— |
|
|
— |
|
Common stock, $0.01 par value Authorized—400,000,000 shares issued
and outstanding—176,801,434 and 173,674,067 shares at June 30,
2022 and December 31, 2021
|
1,769 |
|
|
1,738 |
|
Additional paid-in capital |
6,204,742 |
|
|
6,028,861 |
|
Accumulated other comprehensive loss |
(8,645) |
|
|
(1,443) |
|
Accumulated deficit |
(2,988,520) |
|
|
(2,641,520) |
|
Total stockholders’ equity |
3,209,346 |
|
|
3,387,636 |
|
Total liabilities and stockholders’ equity |
$ |
6,437,155 |
|
|
$ |
6,684,884 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
EXACT SCIENCES CORPORATION
Condensed Consolidated Statements of Operations
(Amounts in thousands, except per share data -
unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
|
2021 |
Revenue |
$ |
521,640 |
|
|
$ |
434,819 |
|
|
$ |
1,008,211 |
|
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$ |
836,896 |
|
|
|
|
|
|
|
|
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Operating expenses |
|
|
|
|
|
|
|
Cost of sales (exclusive of amortization of acquired intangible
assets) |
144,600 |
|
|
113,968 |
|
|
279,305 |
|
|
223,961 |
|
Research and development |
106,083 |
|
|
106,235 |
|
|
208,331 |
|
|
221,802 |
|
Sales and marketing |
215,922 |
|
|
194,827 |
|
|
448,103 |
|
|
380,968 |
|
General and administrative |
181,672 |
|
|
167,629 |
|
|
351,442 |
|
|
435,356 |
|
Amortization of acquired intangible assets |
26,356 |
|
|
23,824 |
|
|
51,010 |
|
|
47,014 |
|
Intangible asset impairment charge |
6,591 |
|
|
— |
|
|
6,591 |
|
|
— |
|
Total operating expenses |
681,224 |
|
|
606,483 |
|
|
1,344,782 |
|
|
1,309,101 |
|
Loss from operations |
(159,584) |
|
|
(171,664) |
|
|
(336,571) |
|
|
(472,205) |
|
|
|
|
|
|
|
|
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Other income (expense) |
|
|
|
|
|
|
|
Investment income (expense), net |
(3,719) |
|
|
3,429 |
|
|
(5,206) |
|
|
34,617 |
|
Interest expense |
(4,511) |
|
|
(4,652) |
|
|
(8,989) |
|
|
(9,268) |
|
Total other income (expense) |
(8,230) |
|
|
(1,223) |
|
|
(14,195) |
|
|
25,349 |
|
|
|
|
|
|
|
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Net loss before tax |
(167,814) |
|
|
(172,887) |
|
|
(350,766) |
|
|
(446,856) |
|
|
|
|
|
|
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Income tax benefit (expense) |
1,751 |
|
|
(4,025) |
|
|
3,766 |
|
|
238,780 |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(166,063) |
|
|
$ |
(176,912) |
|
|
$ |
(347,000) |
|
|
$ |
(208,076) |
|
|
|
|
|
|
|
|
|
Net loss per share—basic and diluted |
$ |
(0.94) |
|
|
$ |
(1.03) |
|
|
$ |
(1.98) |
|
|
$ |
(1.22) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding—basic and
diluted |
176,364 |
|
|
171,494 |
|
|
175,396 |
|
|
170,469 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
EXACT SCIENCES CORPORATION
Condensed Consolidated Statements of Comprehensive
Loss
(Amounts in thousands - unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Net loss |
$ |
(166,063) |
|
|
$ |
(176,912) |
|
|
$ |
(347,000) |
|
|
$ |
(208,076) |
|
Other comprehensive loss, before tax: |
|
|
|
|
|
|
|
Unrealized loss on available-for-sale investments |
(1,488) |
|
|
(297) |
|
|
(6,455) |
|
|
(629) |
|
Foreign currency translation loss |
(510) |
|
|
— |
|
|
(747) |
|
|
— |
|
Comprehensive loss, before tax |
(168,061) |
|
|
(177,209) |
|
|
(354,202) |
|
|
(208,705) |
|
Income tax benefit related to items of other comprehensive
loss |
— |
|
|
— |
|
|
— |
|
|
170 |
|
Comprehensive loss, net of tax |
$ |
(168,061) |
|
|
$ |
(177,209) |
|
|
$ |
(354,202) |
|
|
$ |
(208,535) |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
EXACT SCIENCES CORPORATION
Condensed Consolidated Statements of Stockholders’
Equity
(Amounts in thousands, except share data - unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional Paid-In Capital |
|
Accumulated Other Comprehensive Loss |
|
Accumulated Deficit |
|
Total Stockholders’ Equity |
|
Number of Shares |
|
$0.01
Par Value
|
|
|
|
|
Balance, January 1, 2022 |
173,674,067 |
|
|
$ |
1,738 |
|
|
$ |
6,028,861 |
|
|
$ |
(1,443) |
|
|
$ |
(2,641,520) |
|
|
$ |
3,387,636 |
|
Exercise of common stock options |
485,537 |
|
|
5 |
|
|
4,277 |
|
|
— |
|
|
— |
|
|
4,282 |
|
Compensation expense related to issuance of stock options and
restricted stock awards |
1,391,797 |
|
|
14 |
|
|
52,427 |
|
|
— |
|
|
— |
|
|
52,441 |
|
Other |
7 |
|
|
— |
|
|
(7) |
|
|
— |
|
|
— |
|
|
(7) |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(180,937) |
|
|
(180,937) |
|
Other comprehensive loss
|
— |
|
|
— |
|
|
— |
|
|
(5,204) |
|
|
— |
|
|
(5,204) |
|
Balance, March 31, 2022 |
175,551,408 |
|
|
$ |
1,757 |
|
|
$ |
6,085,558 |
|
|
$ |
(6,647) |
|
|
$ |
(2,822,457) |
|
|
$ |
3,258,211 |
|
Exercise of common stock options |
84,485 |
|
|
1 |
|
|
742 |
|
|
— |
|
|
— |
|
|
743 |
|
Issuance of common stock to fund the Company’s 2021 401(k)
match |
391,129 |
|
|
4 |
|
|
29,198 |
|
|
— |
|
|
— |
|
|
29,202 |
|
Compensation expense related to issuance of stock options and
restricted stock awards |
183,095 |
|
|
2 |
|
|
58,930 |
|
|
— |
|
|
— |
|
|
58,932 |
|
Issuance of common stock for business combinations |
265,186 |
|
|
2 |
|
|
14,788 |
|
|
— |
|
|
— |
|
|
14,790 |
|
Purchase of employee stock purchase plan shares |
326,131 |
|
|
3 |
|
|
15,526 |
|
|
— |
|
|
— |
|
|
15,529 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(166,063) |
|
|
(166,063) |
|
Other comprehensive loss
|
— |
|
|
— |
|
|
— |
|
|
(1,998) |
|
|
— |
|
|
(1,998) |
|
Balance, June 30, 2022 |
176,801,434 |
|
|
$ |
1,769 |
|
|
$ |
6,204,742 |
|
|
$ |
(8,645) |
|
|
$ |
(2,988,520) |
|
|
$ |
3,209,346 |
|
EXACT SCIENCES CORPORATION
Condensed Consolidated Statements of Stockholders’
Equity
(Amounts in thousands, except share data - unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional Paid-In Capital |
|
Accumulated Other Comprehensive Income (Loss) |
|
Accumulated Deficit |
|
Total Stockholders’ Equity |
|
Number of Shares |
|
$0.01
Par Value
|
|
|
|
|
Balance, January 1, 2021 |
159,423,410 |
|
|
$ |
1,595 |
|
|
$ |
4,279,327 |
|
|
$ |
526 |
|
|
$ |
(2,045,896) |
|
|
$ |
2,235,552 |
|
Settlement of convertible notes, net of tax |
344 |
|
|
— |
|
|
26 |
|
|
— |
|
|
— |
|
|
26 |
|
Exercise of common stock options |
967,107 |
|
|
10 |
|
|
8,749 |
|
|
— |
|
|
— |
|
|
8,759 |
|
Issuance of common stock to fund the Company’s 2020 401(k)
match |
162,606 |
|
|
2 |
|
|
22,932 |
|
|
— |
|
|
— |
|
|
22,934 |
|
Compensation expense related to issuance of stock options and
restricted stock awards |
1,355,435 |
|
|
13 |
|
|
158,239 |
|
|
— |
|
|
— |
|
|
158,252 |
|
Issuance of common stock for business combinations, net of issuance
costs |
9,384,410 |
|
|
94 |
|
|
1,254,704 |
|
|
— |
|
|
— |
|
|
1,254,798 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(31,164) |
|
|
(31,164) |
|
Other comprehensive loss
|
— |
|
|
— |
|
|
— |
|
|
(162) |
|
|
— |
|
|
(162) |
|
Balance, March 31, 2021 |
171,293,312 |
|
|
$ |
1,714 |
|
|
$ |
5,723,977 |
|
|
$ |
364 |
|
|
$ |
(2,077,060) |
|
|
$ |
3,648,995 |
|
Settlement of convertible notes, net of tax |
197 |
|
|
— |
|
|
14 |
|
|
— |
|
|
— |
|
|
14 |
|
Exercise of common stock options |
140,478 |
|
|
1 |
|
|
2,857 |
|
|
— |
|
|
— |
|
|
2,858 |
|
Compensation expense related to issuance of stock options and
restricted stock awards |
121,575 |
|
|
2 |
|
|
56,283 |
|
|
— |
|
|
— |
|
|
56,285 |
|
Issuance of common stock for business combinations |
126,026 |
|
|
1 |
|
|
16,119 |
|
|
— |
|
|
— |
|
|
16,120 |
|
Purchase of employee stock purchase plan shares |
173,717 |
|
|
2 |
|
|
12,036 |
|
|
— |
|
|
— |
|
|
12,038 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(176,912) |
|
|
(176,912) |
|
Other comprehensive loss |
— |
|
|
— |
|
|
— |
|
|
(297) |
|
|
— |
|
|
(297) |
|
Balance, June 30, 2021 |
171,855,305 |
|
|
$ |
1,720 |
|
|
$ |
5,811,286 |
|
|
$ |
67 |
|
|
$ |
(2,253,972) |
|
|
$ |
3,559,101 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
EXACT SCIENCES CORPORATION
Condensed Consolidated Statements of Cash Flows
(Amounts in thousands - unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
Cash flows from operating activities: |
|
|
|
Net loss |
$ |
(347,000) |
|
|
$ |
(208,076) |
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation |
48,498 |
|
|
42,007 |
|
Loss on disposal of property, plant and equipment |
166 |
|
|
639 |
|
Unrealized (gain) loss on equity investments |
4,247 |
|
|
(2,486) |
|
Deferred tax benefit |
(4,940) |
|
|
(244,509) |
|
Stock-based compensation |
111,373 |
|
|
133,577 |
|
Post-combination expense for acceleration of unvested
equity |
— |
|
|
80,960 |
|
Realized gain on preferred stock investment |
— |
|
|
(30,500) |
|
Amortization of deferred financing costs, convertible note debt
discount and issuance costs, and other liabilities |
3,420 |
|
|
3,282 |
|
Amortization of premium on short-term investments |
1,493 |
|
|
1,616 |
|
Amortization of acquired intangible assets |
51,010 |
|
|
47,014 |
|
Intangible asset impairment charge |
6,591 |
|
|
— |
|
Asset acquisition IPR&D expense |
— |
|
|
85,337 |
|
Remeasurement of contingent consideration |
(51,759) |
|
|
9,201 |
|
Non-cash lease expense |
17,281 |
|
|
11,837 |
|
Changes in assets and liabilities: |
|
|
|
Accounts receivable, net |
30,632 |
|
|
8,995 |
|
Inventory, net |
(10,178) |
|
|
4,267 |
|
Operating lease liabilities |
(10,668) |
|
|
(7,095) |
|
Accounts payable and accrued liabilities |
(79,339) |
|
|
27,138 |
|
Other assets and liabilities |
(5,497) |
|
|
(94) |
|
Net cash used in operating activities |
(234,670) |
|
|
(36,890) |
|
Cash flows from investing activities: |
|
|
|
Purchases of marketable securities |
(79,110) |
|
|
(915,289) |
|
Maturities and sales of marketable securities |
269,310 |
|
|
325,380 |
|
Purchases of property, plant and equipment |
(96,949) |
|
|
(37,504) |
|
Business combination, net of cash acquired and issuance
costs |
685 |
|
|
(415,549) |
|
Asset acquisition |
— |
|
|
(58,073) |
|
Investments in privately held companies |
(26,667) |
|
|
(10,000) |
|
Other investing activities |
(49) |
|
|
(244) |
|
Net cash provided by (used in) investing activities |
67,220 |
|
|
(1,111,279) |
|
Cash flows from financing activities: |
|
|
|
Proceeds from accounts receivable securitization
facility |
50,000 |
|
|
— |
|
Proceeds from exercise of common stock options |
5,025 |
|
|
11,617 |
|
Proceeds in connection with the Company’s employee stock purchase
plan |
15,529 |
|
|
12,038 |
|
Other financing activities |
(4,407) |
|
|
(3,068) |
|
Net cash provided by financing activities |
66,147 |
|
|
20,587 |
|
Effects of exchange rate changes on cash and cash
equivalents |
(747) |
|
|
— |
|
Net decrease in cash, cash equivalents and restricted
cash |
(102,050) |
|
|
(1,127,582) |
|
Cash, cash equivalents and restricted cash, beginning of
period |
315,768 |
|
|
1,491,594 |
|
Cash, cash equivalents and restricted cash, end of
period |
$ |
213,718 |
|
|
$ |
364,012 |
|
EXACT SCIENCES CORPORATION
Condensed Consolidated Statements of Cash Flows
(Amounts in thousands - unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
Supplemental disclosure of non-cash investing and financing
activities |
|
|
|
Property, plant and equipment acquired but not paid |
$ |
34,604 |
|
|
$ |
15,139 |
|
Business combination contingent consideration liability |
$ |
4,600 |
|
|
$ |
350,348 |
|
Supplemental disclosure of cash flow information: |
|
|
|
Interest paid |
$ |
5,133 |
|
|
$ |
5,414 |
|
Reconciliation of cash, cash equivalents and restricted
cash: |
|
|
|
Cash and cash equivalents |
$ |
213,421 |
|
|
$ |
363,715 |
|
Restricted cash — included in prepaid expenses and other current
assets as of June 30, 2022, and other long-term assets, net as of
June 30, 2021 |
297 |
|
|
297 |
|
Total cash, cash equivalents and restricted cash |
$ |
213,718 |
|
|
$ |
364,012 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Business
Exact Sciences Corporation (together with its subsidiaries,
“Exact,” or the “Company”) was incorporated in February 1995. Exact
is a leading global cancer diagnostics company. It has developed
some of the most impactful tests in cancer screening and
diagnostics, including Cologuard® and Oncotype DX®. Exact is
currently working on the development of additional tests, with the
goal of bringing new, innovative cancer tests to patients
throughout the world.
Basis of Presentation and Principles of Consolidation
The accompanying condensed consolidated financial statements, which
include the accounts of Exact Sciences Corporation and those of its
wholly owned subsidiaries and variable interest entities, are
unaudited and have been prepared on a basis substantially
consistent with the Company’s audited financial statements and
notes as of and for the year ended December 31, 2021 included
in the Company’s Annual Report on Form 10-K (the “2021 Form 10-K”).
All intercompany transactions and balances have been eliminated
upon consolidation. These condensed consolidated financial
statements are prepared in conformity with accounting principles
generally accepted in the United States of America (“GAAP”) and
follow the requirements of the Securities and Exchange Commission
(“SEC”) for interim reporting. In the opinion of management, the
accompanying unaudited condensed consolidated financial statements
contain all adjustments (consisting only of adjustments of a normal
and recurring nature) considered necessary for a fair statement of
its financial position, operating results and cash flows for the
periods presented. The condensed consolidated balance sheet at
December 31, 2021 has been derived from audited financial
statements, but does not contain all of the footnote disclosures
from the 2021 Form 10-K. The results of the Company’s operations
for any interim period are not necessarily indicative of the
results of the Company’s operations for any other interim period or
for a full fiscal year. The statements should be read in
conjunction with the audited financial statements and related notes
included in the 2021 Form 10-K.
Use of Estimates
The preparation of the condensed consolidated financial statements
in conformity with GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of
revenues and expenses during the reporting period. Critical
accounting policies are those that affect the Company’s financial
statements materially and involve difficult, subjective or complex
judgments by management, and actual results could differ from those
estimates. These estimates include revenue recognition, valuation
of intangible assets and goodwill, and accounting for income taxes
among others. The Company’s critical accounting policies and
estimates are explained further in the notes to the condensed
consolidated financial statements in this Quarterly Report and the
2021 Form 10-K.
The spread of the coronavirus (“COVID-19”) has affected many
segments of the global economy, including the cancer screening and
diagnostics industry. The Company assessed certain accounting
matters that generally require consideration of forecasted
financial information in context with the information reasonably
available to the Company and the unknown future impacts of COVID-19
as of June 30, 2022 and through the date of the filing of this
Quarterly Report on Form 10-Q. The accounting matters assessed
included, but were not limited to, the Company’s allowance for
doubtful accounts and credit losses, marketable and non-marketable
investments, software, and the carrying value of the goodwill and
other long-lived assets. The Company’s future assessment of the
magnitude and duration of COVID-19, as well as other factors, could
result in additional material impacts to the Company’s consolidated
financial statements in future reporting periods.
The pandemic and related precautionary measures began to materially
disrupt the Company's operations in March 2020 and may continue to
disrupt the business for an unknown period of time. As a result,
the pandemic had an impact on the Company’s revenues and operating
results.
The ultimate impact of COVID-19 depends on factors beyond the
Company’s knowledge or control, including the duration and severity
of the outbreak, as well as third-party actions taken to contain
its spread and mitigate its public health effects. As a result, the
Company is unable to estimate the extent to which COVID-19 will
negatively impact its financial results or liquidity.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Significant Accounting Policies
During the six months ended June 30, 2022, there were no changes to
the Company’s significant accounting policies as described in the
Company’s Annual Report on Form 10-K for the year ended
December 31, 2021, except as described in the Collateralized
Debt Instruments and Recently Adopted Accounting Pronouncements
sections below.
Collateralized Debt Instruments
Debt instruments that are collateralized by security interests in
financial assets held by the Company are accounted for as a secured
borrowing and therefore: (i) the asset balances pledged as
collateral are included within the applicable balance sheet line
item and the borrowings are included within long-term debt in the
condensed consolidated balance sheet; (ii) interest expense is
included within the condensed consolidated statements of
operations; and (iii) in the case of collateralized accounts
receivable, receipts from customers related to the underlying
accounts receivable are reflected as operating cash flows, and (iv)
borrowings and repayments under the collateralized loans are
reflected as financing cash flows within the condensed consolidated
statements of cash flows.
Reclassifications
Certain prior year amounts have been reclassified to conform to the
current year presentation in the condensed consolidated financial
statements and accompanying notes to the condensed consolidated
financial statements.
Recent Accounting Pronouncements
Recently Adopted Accounting Pronouncements
In October 2021, The Financial Accounting Standards Board (“FASB”)
issued Accounting Standards Update (“ASU”) No. 2021-08,
Business Combinations (Topic 805).
This update requires that an entity (acquirer) recognize and
measure contract assets and contract liabilities acquired in a
business combination in accordance with Accounting Standards
Codification (“ASC”) 606. This differs from the current requirement
to measure contract assets and contract liabilities acquired in a
business combination at fair value. The amendments in this update
should be applied prospectively, and are effective for fiscal years
beginning after December 15, 2022, including interim periods within
those fiscal years. Early adoption is permitted, including adoption
in an interim period. The Company early adopted the amendments in
this update during the first quarter of fiscal year 2022. There was
no material impact to the Company’s condensed consolidated
financial statements.
Net Loss Per Share
Basic net loss per common share was determined by dividing net loss
applicable to common stockholders by the weighted average common
shares outstanding during the period. Basic and diluted net loss
per share is the same because all outstanding common stock
equivalents have been excluded, as they are anti-dilutive as a
result of the Company’s losses.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The following potentially issuable common shares were not included
in the computation of diluted net loss per share because they would
have an anti-dilutive effect due to net losses for each
period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
(In thousands) |
|
2022 |
|
2021 |
Shares issuable in connection with acquisitions (1) |
|
45 |
|
|
157 |
|
Shares issuable upon exercise of stock options |
|
1,683 |
|
|
2,486 |
|
Shares issuable upon the release of restricted stock
awards |
|
5,772 |
|
|
4,334 |
|
Shares issuable upon the release of performance share
units |
|
992 |
|
|
867 |
|
Shares issuable upon conversion of convertible notes |
|
20,309 |
|
|
20,309 |
|
|
|
28,801 |
|
|
28,153 |
|
______________
(1)During
the third quarter of 2021, shares were issued related to holdback
amounts on the previously closed acquisition of Viomics, Inc.
(“Viomics”) causing the decrease in shares issuable as of
June 30, 2022 as compared to June 30, 2021. The remaining
issuable shares relate to the previously closed acquisition of
Paradigm Diagnostics, Inc. (“Paradigm”) in March 2020.
(2) REVENUE
The Company’s revenue is primarily generated by its laboratory
testing services utilizing its Cologuard, Oncotype, and COVID-19
tests. The services are completed upon release of a patient’s test
result to the ordering healthcare provider.
Disaggregation of Revenue
The following table presents the Company’s revenues disaggregated
by revenue source:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
(In thousands) |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Screening |
|
|
|
|
|
|
|
|
Medicare Parts B & C |
|
$ |
135,252 |
|
|
$ |
111,387 |
|
|
$ |
249,007 |
|
|
$ |
212,946 |
|
Commercial |
|
181,186 |
|
|
140,149 |
|
|
342,866 |
|
|
268,023 |
|
Other |
|
37,456 |
|
|
12,401 |
|
|
68,543 |
|
|
23,296 |
|
Total Screening |
|
353,894 |
|
|
263,937 |
|
|
660,416 |
|
|
504,265 |
|
Precision Oncology |
|
|
|
|
|
|
|
|
Medicare Parts B & C |
|
$ |
52,621 |
|
|
$ |
48,310 |
|
|
$ |
105,186 |
|
|
$ |
93,147 |
|
Commercial |
|
45,940 |
|
|
47,144 |
|
|
92,002 |
|
|
93,956 |
|
International |
|
28,341 |
|
|
26,848 |
|
|
57,784 |
|
|
52,904 |
|
Other |
|
27,093 |
|
|
15,507 |
|
|
51,643 |
|
|
27,209 |
|
Total Precision Oncology |
|
153,995 |
|
|
137,809 |
|
|
306,615 |
|
|
267,216 |
|
COVID-19 Testing |
|
$ |
13,751 |
|
|
$ |
33,073 |
|
|
$ |
41,180 |
|
|
$ |
65,415 |
|
Total |
|
$ |
521,640 |
|
|
$ |
434,819 |
|
|
$ |
1,008,211 |
|
|
$ |
836,896 |
|
Screening revenue primarily includes laboratory service revenue
from the Cologuard test while Precision Oncology revenue primarily
includes laboratory service revenue from global Oncotype®
products.
At each reporting period end, the Company conducts an analysis of
the estimates used to calculate the transaction price to determine
whether any new information available impacts those estimates made
in prior reporting periods. The Company recognized revenue from a
change in transaction price of $7.1 million and $11.3 million for
the three and six months ended June 30, 2022, respectively.
The Company recorded a downward adjustment to revenue from a change
in transaction price of $14.7 million and $13.0 million for the
three and six months ended June 30, 2021,
respectively.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company had deferred revenue of $1.2 million and
$1.0 million as of June 30, 2022 and December 31,
2021, respectively. Deferred revenue is reported in other current
liabilities in the Company’s condensed consolidated balance
sheets.
Revenue recognized for the three months ended June 30, 2022 and
2021, which was included in the deferred revenue balance at the
beginning of each period, was $0.1 million and
$10.4 million, respectively. Of the $10.4 million of
revenue recognized for the three months ended June 30, 2021,
$10.3 million related to COVID-19 testing. Revenue recognized
for the six months ended June 30, 2022 and 2021, which was included
in the deferred revenue balance at the beginning of each period,
was $0.4 million and $24.4 million, respectively. Of the
$24.4 million of revenue recognized for the six months ended
June 30, 2021, $24.1 million related to COVID-19
testing.
(3) MARKETABLE SECURITIES
The following table sets forth the Company’s cash, cash
equivalents, restricted cash, and marketable securities at
June 30, 2022 and December 31, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
June 30, 2022 |
|
December 31, 2021 |
Cash, cash equivalents, and restricted cash |
|
|
|
|
Cash and money market |
|
$ |
157,219 |
|
|
$ |
247,335 |
|
Cash equivalents |
|
56,202 |
|
|
68,136 |
|
Restricted cash |
|
297 |
|
|
297 |
|
Total cash, cash equivalents, and restricted cash |
|
213,718 |
|
|
315,768 |
|
Marketable securities |
|
|
|
|
Available-for-sale debt securities |
|
$ |
513,520 |
|
|
$ |
711,669 |
|
Equity securities |
|
1,103 |
|
|
3,336 |
|
Total marketable securities |
|
514,623 |
|
|
715,005 |
|
Total cash and cash equivalents, restricted cash and marketable
securities |
|
$ |
728,341 |
|
|
$ |
1,030,773 |
|
Available-for-sale debt securities at June 30, 2022 consisted
of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Amortized Cost |
|
Gains in Accumulated Other Comprehensive Income (Loss)
(1) |
|
Losses in Accumulated Other Comprehensive Income (Loss)
(1) |
|
Estimated Fair Value |
Cash equivalents |
|
|
|
|
|
|
|
|
Commercial paper |
|
$ |
53,265 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
53,265 |
|
U.S. government agency securities |
|
2,937 |
|
|
— |
|
|
— |
|
|
2,937 |
|
Total cash equivalents |
|
56,202 |
|
|
— |
|
|
— |
|
|
56,202 |
|
Marketable securities |
|
|
|
|
|
|
|
|
Corporate bonds |
|
$ |
157,170 |
|
|
$ |
1 |
|
|
$ |
(2,290) |
|
|
$ |
154,881 |
|
U.S. government agency securities |
|
250,731 |
|
|
1 |
|
|
(4,555) |
|
|
246,177 |
|
Certificates of deposit |
|
24,211 |
|
|
— |
|
|
(12) |
|
|
24,199 |
|
Commercial paper |
|
10,208 |
|
|
— |
|
|
(1) |
|
|
10,207 |
|
Asset backed securities |
|
79,121 |
|
|
— |
|
|
(1,065) |
|
|
78,056 |
|
Total marketable securities |
|
521,441 |
|
|
2 |
|
|
(7,923) |
|
|
513,520 |
|
Total available-for-sale securities |
|
$ |
577,643 |
|
|
$ |
2 |
|
|
$ |
(7,923) |
|
|
$ |
569,722 |
|
______________
(1)Gains
and losses in accumulated other comprehensive income (loss)
(“AOCI”) are reported before tax impact.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Available-for-sale debt securities at December 31, 2021
consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Amortized Cost |
|
Gains in Accumulated Other Comprehensive Income (Loss)
(1) |
|
Losses in Accumulated Other Comprehensive Income (Loss)
(1) |
|
Estimated Fair Value |
Cash equivalents |
|
|
|
|
|
|
|
|
U.S. government agency securities |
|
$ |
3,543 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
3,543 |
|
Commercial paper |
|
64,593 |
|
|
— |
|
|
— |
|
|
64,593 |
|
Total cash equivalents |
|
68,136 |
|
|
— |
|
|
— |
|
|
68,136 |
|
Marketable securities |
|
|
|
|
|
|
|
|
U.S. government agency securities |
|
$ |
250,793 |
|
|
$ |
— |
|
|
$ |
(873) |
|
|
$ |
249,920 |
|
Asset backed securities |
|
94,565 |
|
|
2 |
|
|
(107) |
|
|
94,460 |
|
Commercial paper |
|
6,996 |
|
|
— |
|
|
— |
|
|
6,996 |
|
Certificates of deposit |
|
47,147 |
|
|
2 |
|
|
(10) |
|
|
47,139 |
|
Corporate bonds |
|
313,634 |
|
|
13 |
|
|
(493) |
|
|
313,154 |
|
Total marketable securities |
|
713,135 |
|
|
17 |
|
|
(1,483) |
|
|
711,669 |
|
Total available-for-sale securities |
|
$ |
781,271 |
|
|
$ |
17 |
|
|
$ |
(1,483) |
|
|
$ |
779,805 |
|
______________
(1)Gains
and losses in AOCI are reported before tax impact.
The following table summarizes contractual underlying maturities of
the Company’s available-for-sale debt securities at June 30,
2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due one year or less |
|
Due after one year through five years |
(In thousands) |
|
Cost |
|
Fair Value |
|
Cost |
|
Fair Value |
Cash equivalents |
|
|
|
|
|
|
|
|
Commercial paper |
|
$ |
53,265 |
|
|
$ |
53,265 |
|
|
$ |
— |
|
|
$ |
— |
|
U.S. government agency securities |
|
2,937 |
|
|
2,937 |
|
|
— |
|
|
— |
|
Total cash equivalents |
|
56,202 |
|
|
56,202 |
|
|
— |
|
|
— |
|
Marketable securities |
|
|
|
|
|
|
|
|
U.S. government agency securities |
|
$ |
224,768 |
|
|
$ |
220,874 |
|
|
$ |
25,963 |
|
|
$ |
25,303 |
|
Corporate bonds |
|
123,496 |
|
|
121,974 |
|
|
33,674 |
|
|
32,907 |
|
Certificates of deposit |
|
24,211 |
|
|
24,199 |
|
|
— |
|
|
— |
|
Asset backed securities |
|
— |
|
|
— |
|
|
79,121 |
|
|
78,056 |
|
Commercial paper |
|
10,208 |
|
|
10,207 |
|
|
— |
|
|
— |
|
Total marketable securities |
|
382,683 |
|
|
377,254 |
|
|
138,758 |
|
|
136,266 |
|
Total |
|
$ |
438,885 |
|
|
$ |
433,456 |
|
|
$ |
138,758 |
|
|
$ |
136,266 |
|
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The following table summarizes the gross unrealized losses and fair
values of available-for-sale debt securities in an unrealized loss
position as of June 30, 2022, aggregated by investment
category and length of time those individual securities have been
in a continuous unrealized loss position:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than one year |
|
One year or greater |
|
Total |
(In thousands) |
|
Fair Value |
|
Gross Unrealized Loss |
|
Fair Value |
|
Gross Unrealized Loss |
|
Fair Value |
|
Gross Unrealized Loss |
Marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
Corporate bonds |
|
$ |
149,879 |
|
|
$ |
(2,290) |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
149,879 |
|
|
$ |
(2,290) |
|
Certificates of deposit |
|
24,199 |
|
|
(12) |
|
|
— |
|
|
— |
|
|
24,199 |
|
|
(12) |
|
Asset backed securities |
|
78,056 |
|
|
(1,065) |
|
|
— |
|
|
— |
|
|
78,056 |
|
|
(1,065) |
|
U.S. government agency securities |
|
244,179 |
|
|
(4,555) |
|
|
— |
|
|
— |
|
|
244,179 |
|
|
(4,555) |
|
Commercial paper |
|
2,999 |
|
|
(1) |
|
|
— |
|
|
— |
|
|
2,999 |
|
|
(1) |
|
Total available-for-sale securities |
|
$ |
499,312 |
|
|
$ |
(7,923) |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
499,312 |
|
|
$ |
(7,923) |
|
The Company evaluates investments that are in an unrealized loss
position for impairment as a result of credit loss. It was
determined that no credit losses exist as of June 30, 2022 and
December 31, 2021, because the change in market value for
those securities in an unrealized loss position has resulted from
fluctuating interest rates rather than a deterioration of the
credit worthiness of the issuers.
The gains and losses recorded on available-for-sale debt securities
and equity securities are included in investment income, net in the
Company’s condensed consolidated statements of operations. The
gains and losses recorded were not significant for the three and
six months ended June 30, 2022 and 2021.
(4) INVENTORY
Inventory consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
June 30, 2022 |
|
December 31, 2021 |
Raw materials |
|
$ |
57,087 |
|
|
$ |
51,321 |
|
Semi-finished and finished goods |
|
58,085 |
|
|
53,673 |
|
Total inventory |
|
$ |
115,172 |
|
|
$ |
104,994 |
|
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(5) PROPERTY, PLANT AND EQUIPMENT
The carrying value and estimated useful lives of property, plant
and equipment are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Estimated Useful Life |
|
June 30, 2022 |
|
December 31, 2021 |
Property, plant and equipment |
|
|
|
|
|
|
Land |
|
n/a |
|
$ |
4,716 |
|
|
$ |
4,716 |
|
Leasehold and building improvements |
|
(1) |
|
166,559 |
|
|
147,083 |
|
Land improvements |
|
15 years |
|
5,207 |
|
|
5,206 |
|
Buildings |
|
30 - 40 years
|
|
215,280 |
|
|
210,560 |
|
Computer equipment and computer software |
|
3 years |
|
123,464 |
|
|
109,119 |
|
Laboratory equipment |
|
3 - 10 years
|
|
213,261 |
|
|
189,748 |
|
Furniture and fixtures |
|
3 - 10 years
|
|
29,833 |
|
|
28,293 |
|
Assets under construction |
|
n/a |
|
165,365 |
|
|
100,339 |
|
Property, plant and equipment, at cost |
|
|
|
923,685 |
|
|
795,064 |
|
Accumulated depreciation |
|
|
|
(260,032) |
|
|
(214,816) |
|
Property, plant and equipment, net |
|
|
|
$ |
663,653 |
|
|
$ |
580,248 |
|
______________
(1)Lesser
of remaining lease term, building life, or estimated useful
life.
Depreciation expense for the three months ended June 30, 2022 and
2021 was $25.5 million and $21.5 million, respectively.
Depreciation expense for the six months ended June 30, 2022 and
2021 was $48.5 million and $42.0 million,
respectively.
At June 30, 2022, the Company had $165.4 million of assets
under construction, which consisted of $94.1 million related to
buildings, $41.5 million in laboratory equipment, $15.8 million in
leasehold and building improvements, $13.0 million in capitalized
costs related to software projects, and $1.0 million in land
improvements. Depreciation will begin on these assets once they are
placed into service upon completion.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(6) INTANGIBLE ASSETS AND GOODWILL
Intangible Assets
The following table summarizes the net-book-value and estimated
remaining life of the Company’s intangible assets as of
June 30, 2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Weighted Average Remaining Life (Years) |
|
Gross Carrying Amount |
|
Accumulated Amortization |
|
Net Balance at June 30, 2022
|
Finite-lived intangible assets |
|
|
|
|
|
|
|
|
Trade name |
|
13.0 |
|
$ |
104,000 |
|
|
$ |
(17,028) |
|
|
$ |
86,972 |
|
Customer relationships |
|
8.5 |
|
4,000 |
|
|
(222) |
|
|
3,778 |
|
Patents |
|
3.2 |
|
10,942 |
|
|
(7,458) |
|
|
3,484 |
|
Acquired developed technology (1) |
|
8.1 |
|
920,334 |
|
|
(219,788) |
|
|
700,546 |
|
Supply agreements |
|
4.9 |
|
2,295 |
|
|
(302) |
|
|
1,993 |
|
Total finite-lived intangible assets |
|
|
|
1,041,571 |
|
|
(244,798) |
|
|
796,773 |
|
In-process research and development |
|
n/a |
|
1,250,000 |
|
|
— |
|
|
1,250,000 |
|
Total intangible assets |
|
|
|
$ |
2,291,571 |
|
|
$ |
(244,798) |
|
|
$ |
2,046,773 |
|
______________
(1)The
gross carrying amount includes an immaterial foreign currency
translation adjustment related to the intangible assets acquired as
a result of the acquisition of OmicEra Diagnostics GmbH
(“OmicEra”), whose functional currency is also its local currency.
Intangible asset balances are translated into U.S. dollars using
exchange rates in effect at period end, and adjustments related to
foreign currency translation are included in other comprehensive
income.
The following table summarizes the net-book-value and estimated
remaining life of the Company’s intangible assets as of
December 31, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Weighted Average Remaining Life (Years) |
|
Gross Carrying Amount |
|
Accumulated Amortization |
|
Net balance at December 31, 2021
|
Finite-lived intangible assets |
|
|
|
|
|
|
|
|
Trade name |
|
13.4 |
|
$ |
104,700 |
|
|
$ |
(13,554) |
|
|
$ |
91,146 |
|
Customer relationships |
|
9.6 |
|
6,700 |
|
|
(1,577) |
|
|
5,123 |
|
Patents and licenses |
|
3.6 |
|
10,942 |
|
|
(6,763) |
|
|
4,179 |
|
Acquired developed technology |
|
8.6 |
|
918,171 |
|
|
(176,402) |
|
|
741,769 |
|
Supply agreements |
|
5.4 |
|
2,295 |
|
|
(101) |
|
|
2,194 |
|
Total finite-lived intangible assets |
|
|
|
1,042,808 |
|
|
(198,397) |
|
|
844,411 |
|
In-process research and development |
|
n/a |
|
1,250,000 |
|
|
— |
|
|
1,250,000 |
|
Total intangible assets |
|
|
|
$ |
2,292,808 |
|
|
$ |
(198,397) |
|
|
$ |
2,094,411 |
|
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
As of June 30, 2022, the estimated future amortization expense
associated with the Company’s finite-lived intangible assets for
each of the five succeeding fiscal years is as
follows:
|
|
|
|
|
|
|
|
|
(In thousands) |
|
|
2022 (remaining six months) |
|
$ |
49,288 |
|
2023 |
|
98,574 |
|
2024 |
|
98,240 |
|
2025 |
|
97,192 |
|
2026 |
|
96,132 |
|
Thereafter |
|
357,347 |
|
|
|
$ |
796,773 |
|
The Company’s acquired intangible assets are being amortized on a
straight-line basis over the estimated useful life.
During the second quarter of 2022, the Company recorded a non-cash,
pre-tax impairment loss of $6.6 million related to the
acquired developed technology intangible asset acquired as a result
of the acquisition of Paradigm Diagnostics, Inc. due to lower than
anticipated performance of the underlying product. The impairment
is recorded in intangible asset impairment charge in the condensed
consolidated statement of operations for the three and six months
ended June 30, 2022.
Goodwill
The change in the carrying amount of goodwill for the periods ended
June 30, 2022 and December 31, 2021 is as
follows:
|
|
|
|
|
|
|
|
|
(In thousands) |
|
|
Balance, January 1, 2021
|
|
$ |
1,237,672 |
|
Thrive acquisition |
|
948,105 |
|
Ashion acquisition |
|
56,758 |
|
PreventionGenetics acquisition |
|
92,637 |
|
Balance, December 31, 2021
|
|
2,335,172 |
|
OmicEra acquisition |
|
10,748 |
|
PreventionGenetics acquisition adjustment |
|
42 |
|
Effects of changes in foreign currency exchange rates
(1) |
|
(40) |
|
Balance June 30, 2022
|
|
$ |
2,345,922 |
|
______________
(1)Represents
the impact of foreign currency translation related to the goodwill
acquired as a result of the acquisition of OmicEra. Goodwill
balances are translated into U.S. dollars using exchange rates in
effect at period end, and adjustments related to foreign currency
translation are included in other comprehensive
income.
There were no impairment losses for the three and six months ended
June 30, 2022 and 2021.
(7) FAIR VALUE MEASUREMENTS
The three levels of the fair value hierarchy established are as
follows:
Level 1 Quoted
prices (unadjusted) in active markets for identical assets or
liabilities that the Company has the ability to access as of the
reporting date. Active markets are those in which transactions for
the asset or liability occur in sufficient frequency and volume to
provide pricing information on an ongoing basis.
Level 2 Pricing
inputs other than quoted prices in active markets included in Level
1, which are either directly or indirectly observable as of the
reporting date. These include quoted prices for similar assets or
liabilities in active markets and quoted prices for identical or
similar assets or liabilities in markets that are not
active.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Level 3 Unobservable
inputs that reflect the Company’s assumptions about the assumptions
that market participants would use in pricing the asset or
liability. Unobservable inputs shall be used to measure fair value
to the extent that observable inputs are not
available.
The following table presents the Company’s fair value measurements
as of June 30, 2022 along with the level within the fair value
hierarchy in which the fair value measurements, in their entirety,
fall.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Fair Value at June 30, 2022 |
|
Quoted Prices in Active Markets for Identical Assets
(Level 1) |
|
Significant Other Observable Inputs (Level 2) |
|
Significant Unobservable Inputs (Level 3) |
Cash, cash equivalents, and restricted cash |
|
|
|
|
|
|
|
|
Cash and money market |
|
$ |
157,219 |
|
|
$ |
157,219 |
|
|
$ |
— |
|
|
$ |
— |
|
Commercial paper |
|
53,265 |
|
|
— |
|
|
53,265 |
|
|
— |
|
U.S. government agency securities |
|
2,937 |
|
|
— |
|
|
2,937 |
|
|
— |
|
Restricted cash |
|
297 |
|
|
297 |
|
|
— |
|
|
— |
|
Marketable securities |
|
|
|
|
|
|
|
|
Corporate bonds |
|
$ |
154,881 |
|
|
$ |
— |
|
|
$ |
154,881 |
|
|
$ |
— |
|
Certificates of deposit |
|
24,199 |
|
|
— |
|
|
24,199 |
|
|
— |
|
Commercial paper |
|
10,207 |
|
|
— |
|
|
10,207 |
|
|
— |
|
U.S. government agency securities |
|
246,177 |
|
|
— |
|
|
246,177 |
|
|
— |
|
Asset backed securities |
|
78,056 |
|
|
— |
|
|
78,056 |
|
|
— |
|
Equity securities |
|
1,103 |
|
|
1,103 |
|
|
— |
|
|
— |
|
Non-marketable securities |
|
$ |
2,690 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
2,690 |
|
Liabilities |
|
|
|
|
|
|
|
|
Contingent consideration |
|
$ |
(311,785) |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(311,785) |
|
Total |
|
$ |
419,246 |
|
|
$ |
158,619 |
|
|
$ |
569,722 |
|
|
$ |
(309,095) |
|
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The following table presents the Company’s fair value measurements
as of December 31, 2021 along with the level within the fair
value hierarchy in which the fair value measurements, in their
entirety, fall.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Fair Value at December 31, 2021 |
|
Quoted Prices in Active Markets for Identical Assets
(Level 1) |
|
Significant Other Observable Inputs (Level 2) |
|
Significant Unobservable Inputs (Level 3) |
Cash and cash equivalents |
|
|
|
|
|
|
|
|
Cash and money market |
|
$ |
247,335 |
|
|
$ |
247,335 |
|
|
$ |
— |
|
|
$ |
— |
|
Commercial paper |
|
64,593 |
|
|
— |
|
|
64,593 |
|
|
— |
|
U.S. government agency securities |
|
3,543 |
|
|
— |
|
|
3,543 |
|
|
— |
|
Restricted cash |
|
297 |
|
|
297 |
|
|
— |
|
|
— |
|
Marketable securities |
|
|
|
|
|
|
|
|
U.S. government agency securities |
|
$ |
249,920 |
|
|
$ |
— |
|
|
$ |
249,920 |
|
|
$ |
— |
|
Corporate bonds |
|
313,154 |
|
|
— |
|
|
313,154 |
|
|
— |
|
Asset backed securities |
|
94,460 |
|
|
— |
|
|
94,460 |
|
|
— |
|
Certificates of deposit |
|
47,139 |
|
|
— |
|
|
47,139 |
|
|
— |
|
Commercial paper |
|
6,996 |
|
|
— |
|
|
6,996 |
|
|
— |
|
Equity securities |
|
3,336 |
|
|
3,336 |
|
|
— |
|
|
— |
|
Non-marketable securities |
|
$ |
3,090 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
3,090 |
|
Liabilities |
|
|
|
|
|
|
|
|
Contingent consideration |
|
$ |
(359,021) |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(359,021) |
|
Total |
|
$ |
674,842 |
|
|
$ |
250,968 |
|
|
$ |
779,805 |
|
|
$ |
(355,931) |
|
There have been no changes in valuation techniques or transfers
between fair value measurement levels during the three and six
months ended June 30, 2022. The fair value of Level 2
instruments classified as cash equivalents and marketable debt
securities are valued using a third-party pricing agency where the
valuation is based on observable inputs including pricing for
similar assets and other observable market factors.
Contingent Consideration
The fair value of contingent consideration as of June 30, 2022
and December 31, 2021 was $311.8 million and
$359.0 million, respectively, which was recorded in other
long-term liabilities in the condensed consolidated balance
sheets.
The following table provides a reconciliation of the beginning and
ending balances of contingent consideration:
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Contingent Consideration |
Beginning balance, January 1, 2022 |
|
$ |
359,021 |
|
Purchase price contingent consideration (1) |
|
4,600 |
|
Changes in fair value |
|
(51,759) |
|
Payments |
|
(77) |
|
Ending balance, June 30, 2022
|
|
$ |
311,785 |
|
______________
(1)The
increase in contingent consideration liability is due to the
contingent consideration associated with the acquisition of
OmicEra. Refer to Note 16 for further information.
This fair value measurement of contingent consideration is
categorized as a Level 3 liability, as the measurement amount is
based primarily on significant inputs not observable in the
market.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The fair value of the contingent consideration liability recorded
related to regulatory and product development milestones associated
with the acquisitions of Thrive Earlier Detection Corporation
(“Thrive”), Ashion Analytics, LLC (“Ashion”), and OmicEra
acquisitions was $310.6 million and $357.8 million as of
June 30, 2022 and December 31, 2021, respectively. The
Company evaluates the fair value of the expected contingent
consideration and the corresponding liability related to the
regulatory and product development milestones using the
probability-weighted scenario based discounted cash flow model,
which is consistent with the initial measurement of the expected
contingent consideration liabilities. Probabilities of success are
applied to each potential scenario and the resulting values are
discounted using a present-value factor. The passage of time in
addition to changes in projected milestone achievement timing,
present-value factor, the degree of achievement, if applicable, and
probabilities of success may result in adjustments to the fair
value measurement. The fair value of the contingent consideration
liability recorded related to regulatory and product development
milestones was determined using a weighted average probability of
success of 91% as of June 30, 2022 and December 31, 2021,
and a weighted average present-value factor of 6.5% and 2.3% as of
June 30, 2022 and December 31, 2021, respectively. The
projected fiscal year of payment range is from 2024 to 2027.
Unobservable inputs were weighted by the relative fair value of the
contingent consideration liability.
The fair value of the contingent consideration earnout liability
related to certain revenue milestones associated with the
Biomatrica acquisition was $1.2 million as of June 30,
2022 and December 31, 2021. The revenue milestone associated
with the Ashion acquisition is not expected to be achieved and
therefore no liability has been recorded for this
milestone.
Non-Marketable Equity Investments
As of June 30, 2022 and December 31, 2021, the aggregate
carrying amounts of the Company’s non-marketable equity securities
without readily determinable fair values were $48.7 million
and $25.3 million, respectively, which are classified as a
component of other long-term assets, net in the Company’s condensed
consolidated balance sheets. There have been no material downward
or upward adjustments made on these investments since initial
recognition.
The Company has committed capital to venture capital investment
funds (the “Funds”) of $17.5 million, of which
$14.4 million remained callable through 2033 as of
June 30, 2022. The aggregate carrying amount of the Funds,
which are classified as a component of other long-term assets, net
in the Company’s condensed consolidated balance sheets, were
$3.1 million and $1.5 million as of June 30, 2022
and December 31, 2021, respectively.
Derivative Financial Instruments
The Company enters into foreign currency forward contracts on the
last day of each month to mitigate the impact of adverse movements
in foreign exchange rates related to the remeasurement of monetary
assets and liabilities and hedge our foreign currency exchange rate
exposure. As of June 30, 2022 and December 31, 2021, the
Company had open foreign currency forward contracts with notional
amounts of $28.9 million and $46.7 million, respectively.
The Company's foreign exchange derivative instruments are
classified as Level 2 within the fair value hierarchy as they are
valued using inputs that are observable in the market or can be
derived principally from or corroborated by observable market data.
The fair value of the open foreign currency forward contracts was
zero at June 30, 2022 and December 31, 2021, and there
were no gains or losses recorded to adjust the fair value of the
open foreign currency contract held as of June 30, 2022. The
contracts are closed subsequent to each month-end, and the gains
and losses recorded from the contracts were not material for the
three and six months ended June 30, 2022 and
2021.
(8) LONG-TERM DEBT
Accounts Receivable Securitization Facility
On June 29, 2022, the Company, through a wholly-owned special
purpose entity, Exact Receivables LLC (“Exact Receivables”) entered
into an accounts receivable securitization program (the
“Securitization Facility”) with PNC Bank, National Association
(“PNC”), with a scheduled maturity date of June 29, 2024. The
Securitization Facility provides Exact Receivables with a revolving
line-of-credit of up to $150.0 million of borrowing capacity,
subject to certain borrowing base requirements, by collateralizing
a security interest in the domestic customer accounts receivable of
certain wholly-owned subsidiaries of the Company. The amount
available under the Securitization Facility fluctuates over time
based on the total amount of eligible customer accounts receivable
generated by the Company during the normal course of operations.
The Securitization Facility requires the Company to maintain
minimum borrowings under the facility of $50.0 million. The
debt issuance costs incurred related to the Securitization Facility
were not material and are being amortized over the life of the
Securitization Facility through interest expense within the
condensed consolidated statements of operations.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
In connection with the Securitization Facility, the Company also
entered into two Receivables Purchase Agreements (“Receivable
Purchase Agreements”) on June 29, 2022. The Receivable Purchase
Agreements are among the Company and certain wholly-owned
subsidiaries of the Company, and between the Company and Exact
Receivables. Under the agreements, the wholly-owned subsidiaries
sell all of their right, title and interest of their accounts
receivable to Exact Receivables. The receivables are used to
collateralize borrowings made under the Securitization Facility.
The Company retains the responsibility of servicing the accounts
receivable balances pledged as collateral under the Securitization
Facility and provides a performance guaranty.
As of June 30, 2022, the eligible borrowing base under the
Securitization Facility was $119.2 million of which the
Company elected to collateralize $50.0 million. As of
June 30, 2022, the Company had an outstanding balance of
$50.0 million, which is recorded to long-term debt on the
Company’s condensed consolidated balance sheets. The outstanding
balance accrues interest at a rate equal to a daily secured
overnight financing rate (“SOFR”) rate plus a SOFR adjustment and
an applicable margin. The interest rate was 3.24% at June 30,
2022.
Revolving Loan Agreement
During November 2021, the Company entered into a revolving loan
agreement (the “Revolving Loan Agreement”) with PNC. The Revolving
Loan Agreement provides the Company with a revolving line of credit
of up to $150.0 million (the “Revolver”). The Revolver is
collateralized by the Company’s marketable securities held by PNC,
which must continue to maintain a minimum market value of
$150.0 million. The Revolver is available for general working
capital purposes and all other lawful corporate purposes. In
addition, the Company may request, in lieu of cash advances,
letters of credit with an aggregate stated amount outstanding not
to exceed $20.0 million. The availability of advances under the
line of credit will be reduced by the stated amount of each letter
of credit issued and outstanding.
Borrowings under the Revolving Loan Agreement accrue interest at an
annual rate equal to the sum of the daily Bloomberg Short-Term Bank
Yield Index Rate plus the applicable margin of 0.60%. Loans under
the Revolving Loan Agreement may be prepaid at any time without
penalty. The Revolver’s maturity date is November 5,
2023.
The Company has agreed in the Revolving Loan Agreement to various
financial covenants, and as of June 30, 2022, the Company is
in compliance with all covenants.
During the fourth quarter of 2021, PNC issued a letter of credit of
$2.9 million, which reduced the amount available for cash
advances under the line of credit to $147.1 million as of
June 30, 2022 and December 31, 2021. As of June 30,
2022 and December 31, 2021, the Company has not drawn funds
from, nor are any amounts outstanding under, the Revolving Loan
Agreement.
(9) CONVERTIBLE NOTES
Convertible note obligations included in the condensed consolidated
balance sheet consisted of the following as of June 30,
2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value (1) |
(In thousands) |
|
Principal Amount |
|
Unamortized Debt Discount and Issuance Costs |
|
Net Carrying Amount |
|
Amount |
|
Leveling |
2028 Convertible notes - 0.375%
|
|
$ |
1,150,000 |
|
|
$ |
(17,313) |
|
|
$ |
1,132,687 |
|
|
$ |
767,625 |
|
|
2 |
2027 Convertible notes - 0.375%
|
|
747,500 |
|
|
(10,577) |
|
|
736,923 |
|
|
545,750 |
|
|
2 |
2025 Convertible notes - 1.000%
|
|
315,005 |
|
|
(1,470) |
|
|
313,535 |
|
|
291,058 |
|
|
2 |
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Convertible note obligations included in the condensed consolidated
balance sheet consisted of the following as of December 31,
2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value (1) |
(In thousands) |
|
Principal Amount |
|
Unamortized Debt Discount and Issuance Costs |
|
Net Carrying Amount |
|
Amount |
|
Leveling |
2028 Convertible notes - 0.375%
|
|
$ |
1,150,000 |
|
|
$ |
(18,826) |
|
|
$ |
1,131,174 |
|
|
$ |
1,139,650 |
|
|
2 |
2027 Convertible notes - 0.375%
|
|
747,500 |
|
|
(11,691) |
|
|
735,809 |
|
|
771,794 |
|
|
2 |
2025 Convertible notes - 1.000%
|
|
315,005 |
|
|
(1,756) |
|
|
313,249 |
|
|
415,473 |
|
|
2 |
______________
(1)The
fair values are based on observable market prices for this debt,
which is traded in less active markets and therefore is classified
as a Level 2 fair value measurement.
Summary of Conversion Features
Until the six-months immediately preceding the maturity date of the
applicable series of the Company’s convertible notes (the “Notes”),
each series of Notes is convertible only upon the occurrence of
certain events and during certain periods, as set forth in the
Indentures filed at the time of the original offerings. On or after
the date that is six-months immediately preceding the maturity date
of the applicable series of Notes until the close of business on
the second scheduled trading day immediately preceding the maturity
date, holders may convert such Notes at any time. The Notes will be
convertible into cash, shares of the Company’s common stock (plus,
if applicable, cash in lieu of any fractional share), or a
combination of cash and shares of the Company’s common stock, at
the Company’s election.
It is the Company’s intent and policy to settle all conversions
through combination settlement. The initial conversion rate
is 13.26, 8.96, and 8.21 shares of common stock
per $1,000 principal amount for the convertible notes due
in 2025 (“2025 Notes”), 2027 (“2027 Notes”), and 2028 (“2028
Notes”), respectively, which is equivalent to an initial conversion
price of approximately $75.43, $111.66, and $121.84 per
share of the Company’s common stock for the 2025 Notes, 2027 Notes,
and 2028 Notes, respectively. The 2025 Notes, 2027 Notes, and 2028
Notes are potentially convertible into up to 4.2 million,
6.7 million, and 9.4 million shares, respectively. The
conversion rate is subject to adjustment upon the occurrence of
certain specified events as set forth in the Indentures filed at
the time of the original offerings but will not be adjusted for
accrued and unpaid interest. In addition, holders of the Notes who
convert their Notes in connection with a “make-whole fundamental
change” (as defined in the Indenture), will, under certain
circumstances, be entitled to an increase in the conversion
rate.
If the Company undergoes a “fundamental change” (as defined in the
Indenture), holders of the Notes may require the Company to
repurchase for cash all or part of their Notes at a repurchase
price equal to 100% of the principal amount of the Notes
to be repurchased, plus accrued and unpaid interest.
Based on the closing price of the Company’s common stock of $39.39
on June 30, 2022, the if-converted values on the Notes do not
exceed the principal amount.
The Notes do not contain any financial or operating covenants or
any restrictions on the payment of dividends, the issuance of other
indebtedness or the issuance or repurchase of securities by the
Company.
Ranking of Convertible Notes
The Notes are the Company’s senior unsecured obligations and (i)
rank senior in right of payment to all of its future indebtedness
that is expressly subordinated in right of payment to the Notes;
(ii) rank equal in right of payment to each outstanding series
thereof and to all of the Company’s future liabilities that are not
so subordinated, unsecured indebtedness; (iii) are effectively
junior to all of the Company’s existing and future secured
indebtedness and other secured obligations, to the extent of the
value of the assets securing that indebtedness and other secured
obligations; and (iv) are structurally subordinated to all
indebtedness and other liabilities of the Company’s
subsidiaries.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Issuance Costs
Issuance costs are amortized to interest expense over the term of
the Notes. The following table summarizes the original issuance
costs at the time of issuance for each set of Notes:
|
|
|
|
|
|
|
|
|
(In thousands) |
|
|
January 2025 Notes |
|
$ |
10,284 |
|
June 2025 Notes |
|
7,362 |
|
2027 Notes |
|
14,285 |
|
2028 Notes |
|
24,453 |
|
Interest Expense
Interest expense includes the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
(In thousands) |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Debt issuance costs amortization |
|
$ |
1,428 |
|
|
$ |
1,428 |
|
|
$ |
2,840 |
|
|
$ |
2,840 |
|
Debt discount amortization |
|
37 |
|
|
37 |
|
|
73 |
|
|
73 |
|
Coupon interest expense |
|
2,566 |
|
|
2,566 |
|
|
5,133 |
|
|
5,133 |
|
Total interest expense on convertible notes |
|
4,031 |
|
|
4,031 |
|
|
8,046 |
|
|
8,046 |
|
Other interest expense |
|
480 |
|
|
621 |
|
|
943 |
|
|
1,222 |
|
Total interest expense |
|
$ |
4,511 |
|
|
$ |
4,652 |
|
|
$ |
8,989 |
|
|
$ |
9,268 |
|
The following table summarizes the effective interest rates of the
Notes:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
2025 Convertible Notes |
|
1.18 |
% |
|
1.18 |
% |
|
1.18 |
% |
|
1.18 |
% |
2027 Convertible Notes |
|
0.67 |
% |
|
0.67 |
% |
|
0.67 |
% |
|
0.67 |
% |
2028 Convertible Notes |
|
0.64 |
% |
|
0.64 |
% |
|
0.64 |
% |
|
0.64 |
% |
The remaining period over which the unamortized debt discount will
be recognized as non-cash interest expense is 2.55, 4.71, and 5.67
years for the 2025 Notes, 2027 Notes, and 2028 Notes,
respectively.
(10) LICENSE AND COLLABORATION AGREEMENTS
The Company licenses certain technologies that are, or may be,
incorporated into its technology under several license agreements,
as well as the rights to commercialize certain diagnostic tests
through collaboration agreements. Generally, the license agreements
require the Company to pay single-digit royalties based on net
revenues received using the technologies and may require minimum
royalty amounts, milestone payments, or maintenance
fees.
Mayo
In June 2009, the Company entered into a license agreement
with the Mayo Foundation for Medical Education and Research
(“Mayo”). The Company’s license agreement with Mayo was most
recently amended and restated in September 2020. Under the license
agreement, Mayo granted the Company an exclusive, worldwide license
to certain Mayo patents and patent applications, as well as a
non-exclusive, worldwide license with regard to certain Mayo
know-how. The scope of the license covers any screening,
surveillance or diagnostic test or tool for use in connection with
any type of cancer, pre-cancer, disease or condition.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The licensed Mayo patents and patent applications contain both
method and composition claims that relate to sample processing,
analytical testing and data analysis associated with nucleic acid
screening for cancers and other diseases. The jurisdictions covered
by these patents and patent applications include the U.S.,
Australia, Canada, the European Union, China, Japan and Korea.
Under the license agreement, the Company assumed the obligation and
expense of prosecuting and maintaining the licensed Mayo patents
and is obligated to make commercially reasonable efforts to bring
to market products using the licensed Mayo intellectual
property.
Pursuant to the Company’s agreement with Mayo, the
Company is required to pay Mayo a low-single-digit royalty on
the Company’s net sales of current and future products using the
licensed Mayo intellectual property each year during the term
of the Mayo agreement.
As part of the most recent amendment, the Company agreed to pay
Mayo an additional $6.3 million, payable in five equal annual
installments through 2024. The annual installments are recorded in
research and development expenses in the Company’s condensed
consolidated statements of operations.
The license agreement will remain in effect, unless earlier
terminated by the parties in accordance with the agreement, until
the last of the licensed patents expires in 2039 (or later, if
certain licensed patent applications are issued). However, if the
Company is still using the licensed Mayo know-how or certain
Mayo-provided biological specimens or their derivatives on such
expiration date, the term shall continue until the earlier of the
date the Company stops using such know-how and materials and the
date that is five years after the last licensed patent expires. The
license agreement contains customary termination provisions and
permits Mayo to terminate the license agreement if the Company sues
Mayo or its affiliates, other than any such suit claiming an
uncured material breach by Mayo of the license
agreement.
In addition to granting the Company a license to the covered Mayo
intellectual property, Mayo provides the Company with product
development and research and development assistance pursuant to the
license agreement and other collaborative arrangements. In
September 2020, Mayo also agreed to make available certain
personnel to provide such assistance through January 2025. In
connection with this collaboration, the Company incurred charges of
$1.3 million and $1.0 million for the three months ended June 30,
2022 and 2021, respectively. The Company incurred charges of
$2.7 million and $2.2 million for the six months ended
June 30, 2022 and 2021, respectively. The charges incurred in
connection with this collaboration are recorded in research and
development expenses in the Company’s condensed consolidated
statements of operations.
Johns Hopkins University (“JHU”)
Through the acquisition of Thrive, the Company acquired a worldwide
exclusive license agreement with JHU for use of several JHU patents
and licensed know-how. The license is designed to enable the
Company to leverage JHU proprietary data in the development and
commercialization of a blood-based, multi-cancer early detection
test. The agreement terms include single-digit sales-based
royalties and sales-based milestone payments of $10.0 million,
$15.0 million, and $20.0 million upon achieving calendar year
licensed product revenue using JHU proprietary data of $0.50
billion, $1.00 billion, and $1.50 billion,
respectively.
(11) PFIZER PROMOTION AGREEMENT
In August 2018, the Company entered into a Promotion Agreement (the
“Original Promotion Agreement”) with Pfizer Inc. (“Pfizer”), which
was amended and restated in October 2020 (the “Restated Promotion
Agreement”). The Restated Promotion Agreement extended the
relationship between the Company and Pfizer and restructured the
manner in which the Company compensates Pfizer for promotion of the
Cologuard test through a service fee, and provision of certain
other sales and marketing services related to the Cologuard test.
The Restated Promotion Agreement included fixed and
performance-related fees, some of which retroactively went into
effect on April 1, 2020. In November 2021, the Company and Pfizer
entered into an amendment to the Restated Promotion Agreement (the
“November 2021 Amendment”), which provided that after November 30,
2021, Pfizer will no longer promote the Cologuard test to
healthcare providers. The November 2021 Amendment provides that the
Company will pay Pfizer a total of $35.9 million in three
installments during the second, third, and fourth quarters of 2022.
The November 2021 Amendment eliminated the Company's obligation to
pay Pfizer royalties or other fees except for certain media fees,
advertising fees, and any detail fees owed to Pfizer for promoting
the Cologuard test prior to November 30, 2021. The $35.9 million
fee incurred as a result of the November 2021 Amendment was
recognized in full during the fourth quarter of 2021. All payments
to Pfizer are recorded in sales and marketing expenses in the
Company’s condensed consolidated statements of
operations.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Under the Original Promotion Agreement, the service fee was
calculated based on incremental gross profits over specified
baselines during the term. Under the Restated Promotion Agreement
(and prior to giving effect to the November 2021 Amendment), the
service fee provided a fee-for-service model that included certain
fixed fees and performance-related bonuses. The performance-related
bonuses were contingent upon the achievement of certain annual
performance criteria with any applicable expense being recognized
ratably upon achievement of the payment becoming probable. The
Company incurred charges of $2.5 million and
$24.1 million for the service fee for the three months ended
June 30, 2022 and 2021, respectively. The Company incurred charges
of $5.0 million and $46.8 million for the service fee for
the six months ended June 30, 2022 and 2021, respectively. The
Company incurred charges of $27.1 million and $31.1 million for
promotion, sales and marketing services performed by Pfizer on
behalf of the Company during the three months ended June 30, 2022
and 2021, respectively. The Company incurred charges of $65.5
million and $57.7 million for promotion, sales and marketing
services performed by Pfizer on behalf of the Company during the
six months ended June 30, 2022 and 2021, respectively.
(12) STOCKHOLDERS’ EQUITY
OmicEra Diagnostics Acquisition Stock Issuance
In May 2022, the Company completed its acquisition of OmicEra. In
connection with the acquisition, which is further described in Note
16, the Company issued 0.3 million shares of the Company's
common stock that had a fair value of $14.8 million.
PreventionGenetics LLC (“PreventionGenetics”) Acquisition Stock
Issuance
In December 2021, the Company completed its acquisition of
PreventionGenetics. In connection with the acquisition, which is
further described in Note 16, the Company issued 1.1 million
shares of the Company's common stock that had a fair value of
$84.2 million.
Ashion Acquisition Stock Issuance
In April 2021, the Company completed its acquisition of Ashion. In
connection with the acquisition, which is further described in Note
16, the Company issued 0.1 million shares of the Company’s
common stock that had a fair value of $16.2 million.
Thrive Acquisition Stock Issuance
In January 2021, the Company completed its acquisition of Thrive.
In connection with the acquisition, which is further described in
Note 16, the Company issued 9.3 million shares of the
Company’s common stock that had a fair value of $1.19
billion.
Targeted Digital Sequencing (“TARDIS”) License Acquisition Stock
Issuance
In January 2021, the Company acquired a worldwide exclusive license
to the TARDIS technology from The Translational Genomics Research
Institute (“TGen”), which is further described in Note 16. As part
of the consideration transferred, the Company issued
0.2 million shares of the Company’s common stock that had a
fair value of $27.3 million.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Changes in Accumulated Other Comprehensive Income
(Loss)
The amount recognized in AOCI for the six months ended
June 30, 2022 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Foreign Currency Translation Adjustments |
|
Unrealized Gain (Loss) on Marketable Securities (1) |
|
Accumulated Other Comprehensive Income (Loss) |
Balance at December 31, 2021 |
|
$ |
23 |
|
|
$ |
(1,466) |
|
|
$ |
(1,443) |
|
Other comprehensive loss before reclassifications |
|
(747) |
|
|
(6,551) |
|
|
(7,298) |
|
Amounts reclassified from accumulated other comprehensive
loss |
|
— |
|
|
96 |
|
|
96 |
|
Net current period change in accumulated other comprehensive
loss |
|
(747) |
|
|
(6,455) |
|
|
(7,202) |
|
Balance at June 30, 2022 |
|
$ |
(724) |
|
|
$ |
(7,921) |
|
|
$ |
(8,645) |
|
______________
(1)There
was no tax impact from the amounts recognized in AOCI for the three
and six months ended June 30, 2022.
The amounts recognized in AOCI for the six months ended June 30,
2021 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
Unrealized Gain (Loss) on Marketable Securities |
|
Accumulated Other Comprehensive Income (Loss) |
Balance at December 31, 2020 |
|
$ |
526 |
|
|
$ |
526 |
|
Other comprehensive loss before reclassifications |
|
(399) |
|
|
(399) |
|
Amounts reclassified from accumulated other comprehensive
income |
|
(230) |
|
|
(230) |
|
Net current period change in accumulated other comprehensive
income, before tax |
|
(629) |
|
|
(629) |
|
Income tax benefit related to items of other comprehensive
income |
|
170 |
|
|
170 |
|
Balance at June 30, 2021 |
|
$ |
67 |
|
|
$ |
67 |
|
Amounts reclassified from AOCI for the six months ended
June 30, 2022 and 2021 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Affected Line Item in the
Statements of Operations |
|
Six Months Ended June 30, |
Details about AOCI Components (In thousands) |
|
|
2022 |
|
2021 |
Change in value of available-for-sale investments |
|
|
|
|
|
|
Sales and maturities of available-for-sale investments |
|
Investment income (expense), net |
|
$ |
96 |
|
|
$ |
(230) |
|
Total reclassifications |
|
|
|
$ |
96 |
|
|
$ |
(230) |
|
(13) STOCK-BASED COMPENSATION
Stock-Based Compensation Plans
The Company maintains the following plans for which awards were
granted from or had shares outstanding in 2022: 2010 Omnibus
Long-Term Incentive Plan (As Amended and Restated Effective July
27, 2017), the 2019 Omnibus Long-Term Incentive Plan, and the 2010
Employee Stock Purchase Plan (collectively referred to as the
“Stock Plans”).
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Stock-Based Compensation Expense
The Company records stock-based compensation expense in connection
with the amortization of restricted stock and restricted stock unit
awards (“RSUs”), stock purchase rights granted under the Company’s
employee stock purchase plan and stock options granted to
employees, non-employee consultants and non-employee directors. The
Company recorded $58.9 million and $56.3 million in stock-based
compensation expense during the three months ended June 30, 2022
and 2021, respectively. The Company recorded $111.4 million
and $219.7 million in stock-based compensation expense during
the six months ended June 30, 2022 and 2021,
respectively.
As of June 30, 2022, there was approximately $472.7 million of
expected total unrecognized compensation cost related to non-vested
share-based compensation arrangements granted under all equity
compensation plans. The Company expects to recognize that cost over
a weighted average period of 2.9 years.
In connection with the acquisition of Thrive, the Company
accelerated the vesting of shares of previously unvested stock
options and restricted stock units for employees with qualifying
termination events. During the three months ended June 30,
2021, the Company accelerated 4,982 shares of previously unvested
stock options and 5,827 shares of previously unvested restricted
stock awards and restricted stock units and recorded $1.0 million
of non-cash stock-based compensation for the accelerated awards.
During the six months ended June 30, 2021, the Company accelerated
103,996 shares of previously unvested stock options and 33,306
shares of previously unvested restricted stock awards and
restricted stock units and recorded $14.5 million of non-cash
stock-based compensation for the accelerated awards. As further
discussed in Note 16, the Company also recorded $86.2 million in
stock-based compensation related to accelerated vesting of awards
held by Thrive employees in connection with the
acquisition.
Stock Options
A summary of stock option activity under the Stock Plans is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options |
|
Shares |
|
Weighted Average Exercise Price |
|
Weighted Average Remaining Contractual Term (Years) |
|
Aggregate Intrinsic Value (1) |
(Aggregate intrinsic value in thousands) |
|
|
|
|
|
|
|
|
Outstanding, January 1, 2022 |
|
2,284,276 |
|
|
$ |
34.65 |
|
|
5.5 |
|
|
Granted |
|
— |
|
|
— |
|
|
|
|
|
Exercised |
|
(570,138) |
|
|
8.83 |
|
|
|
|
|
Forfeited |
|
(31,385) |
|
|
79.11 |
|
|
|
|
|
Outstanding, June 30, 2022 |
|
1,682,753 |
|
|
$ |
42.57 |
|
|
5.3 |
|
$ |
22,630 |
|
Vested and expected to vest, June 30, 2022
|
|
1,682,753 |
|
|
$ |
42.57 |
|
|
5.3 |
|
$ |
22,630 |
|
Exercisable, June 30, 2022 |
|
1,448,347 |
|
|
$ |
37.22 |
|
|
5.0 |
|
$ |
20,988 |
|
______________
(1)The
total intrinsic value of options exercised during the six months
ended June 30, 2022 and 2021 was $32.5 million and $140.2
million, respectively, determined as of the date of
exercise.
The Company received approximately $5.0 million and $11.6 million
from stock option exercises during the six months ended
June 30, 2022 and 2021, respectively.
Restricted Stock and Restricted Stock Units
The fair value of restricted stock and restricted stock units is
determined on the date of grant using the closing stock price on
that day.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
A summary of restricted stock and restricted stock unit activity
during the six months ended June 30, 2022 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock and restricted stock units |
|
Shares |
|
Weighted Average Grant Date Fair Value (1) |
Outstanding, January 1, 2022 |
|
4,320,910 |
|
|
$ |
108.84 |
|
Granted |
|
3,313,712 |
|
|
74.52 |
|
Released (2) |
|
(1,256,999) |
|
|
97.38 |
|
Forfeited |
|
(605,450) |
|
|
93.95 |
|
Outstanding, June 30, 2022 |
|
5,772,173 |
|
|
$ |
92.31 |
|
______________
(1)The
weighted average grant date fair value of the restricted stock
units granted during the six months ended June 30, 2021 was
$140.63.
(2)The
fair value of restricted stock units vested and converted to shares
of the Company’s common stock was $122.4 million and $93.1 million
during the six months ended June 30, 2022 and 2021,
respectively.
Performance Share Units
The Company has issued performance-based equity awards to certain
employees which vest upon the achievement of certain performance
goals, including financial performance targets and operational
milestones.
In January 2022, the Company issued additional performance-based
equity awards, which include a market condition in the form of a
total shareholder return (“TSR”) modifier. At the end of the
three-year performance period, the total units earned, if any, are
adjusted by applying the modifier, ranging from 50% to 150%. The
TSR modifier is based on stock price performance relative to a
group of peer companies for the same three-year period. The fair
value of the awards granted was calculated using a Monte Carlo
simulation model, as the TSR modifier contains a market
condition.
A summary of performance share unit activity is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Performance share units |
|
Shares (1) |
|
Weighted Average Grant Date Fair Value (2) |
Outstanding, January 1, 2022 |
|
878,114 |
|
|
$ |
107.18 |
|
Granted |
|
744,844 |
|
|
92.05 |
|
Released (3) |
|
(292,134) |
|
|
93.22 |
|
Forfeited |
|
(338,977) |
|
|
114.78 |
|
Outstanding, June 30, 2022 |
|
991,847 |
|
|
$ |
105.81 |
|
______________
(1)The
performance share units listed above assumes attainment of maximum
payout rates as set forth in the performance criteria. Applying
actual or expected payout rates, the number of outstanding
performance share units as of June 30, 2022 was
256,242.
(2)The
weighted average grant date fair value of the performance share
units granted during the six months ended June 30, 2021 was
$140.96.
(3)The
fair value of performance share units vested and converted to
shares of the Company’s common stock was $27.2 million for the six
months ended June 30, 2022. There were no performance share
units vested and converted to shares of the Company’s common stock
during the six months ended June 30, 2021.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Employee Stock Purchase Plan (“ESPP”)
The fair value of ESPP shares is based on the assumptions in the
following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
ESPP Shares |
|
|
|
|
|
|
|
|
Risk-free interest rates |
|
1.49% - 2.73%
|
|
0.04% - 0.16%
|
|
1.49% - 2.73%
|
|
0.04% - 0.16%
|
Expected term (in years) |
|
0.5 - 2
|
|
0.5 - 2
|
|
0.5 - 2
|
|
0.5 - 2
|
Expected volatility |
|
50.94% - 60.34%
|
|
48.38% - 68.51%
|
|
50.94% - 60.34%
|
|
48.38% - 68.51%
|
Dividend yield |
|
—% |
|
—% |
|
—% |
|
—% |
(14) COMMITMENTS AND CONTINGENCIES
Leases
Supplemental disclosure of cash flow information related to the
Company’s cash and non-cash activities with its leases are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
(In thousands) |
|
2022 |
|
2021 |
Cash paid for amounts included in the measurement of lease
liabilities: |
|
|
|
|
Operating cash flows from operating leases |
|
$ |
15,899 |
|
$ |
12,309 |
Operating cash flows from finance leases |
|
56 |
|
480 |
Finance cash flows from finance leases |
|
2,845 |
|
2,443 |
Non-cash investing and financing activities: |
|
|
|
|
Right-of-use assets obtained in exchange for new operating lease
liabilities (1) |
|
$ |
22,158 |
|
$ |
54,451 |
Right-of-use assets obtained in exchange for new finance lease
liabilities |
|
6,033 |
|
2,308 |
Weighted-average remaining lease term - operating leases (in
years) |
|
7.33 |
|
8.43 |
Weighted-average remaining lease term - finance leases (in
years) |
|
3.64 |
|
3.28 |
Weighted-average discount rate - operating leases |
|
6.11 |
% |
|
6.32 |
% |
Weighted-average discount rate - finance leases |
|
6.09 |
% |
|
5.54 |
% |
_____________
(1)For
the six months ended June 30, 2022, this includes right-of-use
assets recorded as a result of the lease modification discussed
below of $8.1 million. For the six months ended June 30, 2021,
this includes right-of-use assets acquired as part of the business
combinations described in Note 16 of $39.6 million.
As of June 30, 2022 and December 31, 2021, the Company’s
right-of-use assets from operating leases are $182.5 million and
$174.2 million, respectively, which are reported in operating lease
right-of-use assets in the Company’s condensed consolidated balance
sheets. As of June 30, 2022, the Company has outstanding
operating lease obligations of $213.0 million, of which $25.8
million is reported in operating lease liabilities, current portion
and $187.2 million is reported in operating lease liabilities, less
current portion in the Company’s condensed consolidated balance
sheets. As of December 31, 2021, the Company had outstanding
operating lease obligations of $201.9 million, of which $19.7
million is reported in operating lease liabilities, current portion
and $182.2 million is reported in operating lease liabilities, less
current portion in the Company’s condensed consolidated balance
sheets.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
As of June 30, 2022 and December 31, 2021, the Company’s
right-of-use assets from finance leases are $9.5 million and $18.2
million, respectively, which are reported in
other long-term assets, net in the Company’s condensed
consolidated balance sheets. As of June 30, 2022, the Company
has outstanding finance lease obligations of $9.7 million, of which
$2.6 million is reported in
other current liabilities and $7.1 million is
reported in
other long-term liabilities in the Company’s
condensed consolidated balance sheets. As of December 31,
2021, the Company had outstanding finance lease obligations of
$18.7 million, of which $6.2 million is reported in other current
liabilities and $12.5 million is reported in other long-term
liabilities in the Company’s condensed consolidated balance
sheets.
On June 1, 2022, certain of the Company’s vehicle leases were
amended. The Company determined that this amendment was a lease
modification, effective June 1, 2022. Under the lease modification
guidance within ASC 842, the Company reassessed the lease
classification and remeasured the corresponding right-of-use assets
and lease liabilities. The Company determined that a portion of the
modified leases are to be accounted for as operating leases, and
therefore derecognized the previous finance lease right-of-use
asset of $10.3 million and the related finance lease liability of
$10.8 million, and recognized an operating lease right-of-use asset
of $8.1 million and the related operating lease liability of $8.6
million.
Legal Matters
The Company records reserves and accrues costs for certain legal
proceedings and regulatory matters to the extent that it determines
an unfavorable outcome is probable and the amount of the loss can
be reasonably estimated. While such reserves and accrued costs
reflect the Company’s best estimate of the probable loss for such
matters, the recorded amounts may differ materially from the actual
amount of any such losses. In some cases, no estimate of the
possible loss or range of loss in excess of amounts accrued, if
any, can be made because of the inherently unpredictable nature of
legal and regulatory proceedings, which may be exacerbated by
various factors, including but not limited to, they may involve
indeterminate claims for monetary damages or may involve fines,
penalties or punitive damages; present novel legal theories or
legal uncertainties; involve disputed facts; represent a shift in
regulatory policy; involve a large number of parties, claimants or
regulatory bodies; are in the early stages of the proceedings;
involve a number of separate proceedings and/or a wide range of
potential outcomes; or result in a change of business
practices.
As of the date of this Quarterly Report on Form 10-Q, amounts
accrued for legal proceedings and regulatory matters were not
material except for the amounts accrued related to the Medicare
Date of Service Rule Investigation (the “DOS Rule Investigation”)
discussed below. However, it is possible that in a particular
quarter or annual period the Company’s financial condition, results
of operations, cash flow and/or liquidity could be materially
adversely affected by an ultimate unfavorable resolution of, or
development in, legal and/or regulatory proceedings, including as
described below. Except for the proceedings discussed below, the
Company believes that the ultimate outcome of any of the regulatory
and legal proceedings that are currently pending against it should
not have a material adverse effect on financial condition, results
of operations, cash flow or liquidity.
The Company is currently responding to civil investigative demands
and administrative subpoenas issued pursuant to the Health
Insurance Portability and Accountability Act of 1996 by the United
States Department of Justice (“DOJ”) concerning Genomic Health’s
compliance with the Medicare Date of Service billing regulations.
The Company has been cooperating with these inquiries and has
produced documents in response thereto.
During the second quarter of 2021, as part of ongoing discussions
between the DOJ and the Company regarding the DOS Rule
Investigation, the DOJ presented an initial estimate of civil
damages in the amount of $48.2 million relating to alleged
non-compliance with the Medicare Date of Service billing
regulations from 2007 to 2020. The initial civil damages estimate
did not include potential treble damages, civil or criminal
penalties or other remedies that the DOJ could seek against the
Company. The DOJ has since presented a total adjusted demand of
$53.8 million for civil damages, which includes a multiplier and
penalties. Based on the Company’s review and analysis of the DOJ
presentation, ongoing discussions held with the DOJ, the civil
damages estimate, and range of potential exposure, the Company
recorded an accrual of approximately $10 million as of
June 30, 2022.
As noted above, litigation outcomes are difficult to predict, and
the estimation of probable losses requires an analysis of multiple
possible outcomes that often depend on judgments about potential
actions by third parties. Accordingly, the recorded accrual of
approximately $10 million as of June 30, 2022 is based on
several factors, considerations, and judgments, and the ultimate
resolution of this matter could result in a material loss in excess
of the recorded accrual.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
On June 24, 2019, Niles Rosen M.D. filed a sealed ex parte qui tam
lawsuit against the Company in the United States District Court for
the Middle District of Florida, that alleged a violation of the
Federal Anti-Kickback Statute and False Claims Act for offering
gift cards to patients in exchange for returning the Cologuard
screening test (the “Qui Tam Suit”). Dr. Rosen seeks on behalf of
the U.S. government and himself an award of civil penalties, treble
damages and fees and costs. On February 25, 2020, the Company
received a civil investigative demand by the DOJ related to the
Company’s gift card program. The Company produced documents in
response thereto. On March 25, 2021, the DOJ filed a notice of its
election to decline intervention in the Qui Tam Suit. This election
does not prevent Dr. Rosen from continuing the Qui Tam Suit. On
April 12, 2021, Dr. Rosen filed an amended complaint against the
Company, alleging violations of the Federal Anti-Kickback Statute
and False Claims Act. The Company first learned of the Qui Tam Suit
and the DOJ’s election to decline intervention in July 2021. The
Company intends to vigorously defend itself against Dr. Rosen's
claims and seek, among other things, the Company’s attorneys' fees
and costs incurred in defending this action. Although the Company
denies Dr. Rosen's allegations and believes that it has meritorious
defenses to his False Claims Act claims, neither the outcome of the
litigation nor can a reasonable estimate or an estimated range of
loss associated with the litigation be determined at this
time.
Adverse outcomes from the DOS Rule Investigation and the Qui Tam
Suit could include the Company being required to pay treble
damages, incur civil and criminal penalties, paying attorneys’
fees, entering into a corporate integrity agreement, being excluded
from participation in government healthcare programs, including
Medicare and Medicaid, and other adverse actions that could
materially affect the Company’s business, financial condition, and
results of operation.
(15) WISCONSIN ECONOMIC DEVELOPMENT TAX CREDITS
During February 2015, the Company entered into an agreement with
the Wisconsin Economic Development Corporation (“WEDC,” “Original
WEDC Agreement”) to earn $9.0 million in refundable tax credits on
the condition that the Company expends $26.3 million in capital
investments and establishes and maintains 758 full-time positions
over a seven-year period.
During December 2021, the Company amended its agreement with the
WEDC (“Amended WEDC Agreement”) to earn an additional
$18.5 million in refundable tax credits on the condition that
the Company expends $350.0 million in capital investments and
establishes and maintains 1,300 additional full-time positions over
a five-year period. The capital investment credits are earned at a
rate of 10% of eligible capital investments up to a maximum of
$7.0 million, while the jobs creation credits are earned
annually pursuant to the agreement.
The tax credits earned are first applied against the tax liability
otherwise due, and if there is no such liability present, the claim
for tax credits will be reimbursed in cash to the Company. The
maximum amount of the refundable tax credit to be earned for each
year is fixed, and the Company earns the credits by meeting certain
capital investment and job creation thresholds over the term of the
agreement. Should the Company earn and receive the job creation tax
credits but not maintain those full-time positions through the end
of the agreement, the Company may be required to pay those credits
back to the WEDC.
Under the Original WEDC Agreement, the Company recorded the earned
tax credits as job creation and capital investments occurred. The
tax credits earned from capital investment are being recognized as
an offset to depreciation expense over the expected life of the
acquired capital assets. The tax credits earned related to job
creation were recognized as an offset to operational expenses
through December 31, 2020.
As of June 30, 2022, the Company has earned all $9.0 million
of the refundable tax credits and has received payment of $9.0
million from the WEDC under the Original WEDC
Agreement.
Under the Amended WEDC Agreement, the Company records the earned
tax credits as job creation and capital investments occurs. The tax
credits earned from capital investment are recognized as a
reduction to capital expenditures at the time the costs are
incurred, and then as an offset to depreciation expense over the
expected life of the acquired capital assets. The tax credits
earned related to job creation are recognized as an offset to
operational expenses in the period in which the credits are earned.
The credits recognized will be required to be repaid if the Company
does not maintain minimum cumulative job requirements.
As of June 30, 2022, the Company has earned $9.0 million
of the refundable tax credits under the Amended WEDC Agreement. The
unpaid portion is $9.0 million as of June 30, 2022, of
which $1.7 million is reported in prepaid expenses and other
current assets and $7.3 million is reported in other long-term
assets, net in the Company’s condensed consolidated balance sheets
reflecting when collection of the refundable tax credits is
expected to occur.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
During the three and six months ended June 30, 2022, the
Company recorded zero and $1.0 million respectively, as a
reduction to operational expenses for the credits earned for job
creation.
(16) BUSINESS COMBINATIONS AND ASSET ACQUISITIONS
Business Combinations
OmicEra Diagnostics, GmbH
On May 2, 2022, the Company completed the acquisition (the “OmicEra
Acquisition”) of all of the outstanding equity interests of OmicEra
Diagnostics GmbH. The OmicEra Acquisition provided the Company a
state-of-the-art proteomics lab based in Planegg, Germany. OmicEra
combines its mass spectrometry-based proteome analysis technology
with its in-house proteomics scientific expertise to discover more
reliable and valuable protein biomarkers, which will expand the
Company’s research and development capabilities. The Company has
included the financial results of OmicEra in the consolidated
financial statements from the date of the combination.
The combination date fair value of the consideration transferred
for OmicEra was approximately $19.4 million, which consisted
of the following:
|
|
|
|
|
|
|
|
|
(In thousands) |
|
|
Common stock issued |
|
$ |
14,792 |
|
Contingent consideration |
|
4,600 |
|
Working capital adjustment to be settled in cash |
|
16 |
|
Total purchase price |
|
$ |
19,408 |
|
The fair value of the 265,186 common shares issued as part of the
consideration transferred was determined on the basis of the
average of the high and low market price of the Company’s shares on
the acquisition date, which was $55.78.
The purchase agreement requires the Company to pay a maximum of
$6.0 million of additional cash consideration to OmicEra upon
the achievement of certain earnout conditions related to the
identification of protein biomarkers, as well as the growth of the
proteomics research and development team. The fair value of the
contingent consideration at the acquisition date was
$4.6 million. The fair value of the contingent consideration
was estimated using a probability-weighted scenario-based
discounted cash flow model. This fair value measurement is based on
significant inputs not observable in the market and thus represents
a Level 3 measurement as defined in ASC 820. The key assumptions
are described in Note 7.
The following table summarizes the preliminary estimated fair
values of the assets acquired and liabilities assumed at the
acquisition date.
|
|
|
|
|
|
|
|
|
(In thousands) |
|
|
Net operating assets |
|
$ |
2,586 |
|
Developed technology |
|
10,000 |
|
Total identifiable assets acquired |
|
12,586 |
|
|
|
|
Net operating liabilities |
|
(3,926) |
|
Net identifiable assets acquired |
|
8,660 |
|
|
|
|
Goodwill |
|
10,748 |
|
Net assets acquired |
|
$ |
19,408 |
|
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The Company recorded $10.0 million of identifiable intangible
assets related to the developed technology associated with
OmicEra’s proteome analysis platform. Developed technology
represents purchased technology that had reached technological
feasibility and for which OmicEra had substantially completed
development as of the date of combination. The fair value of the
developed technology has been determined using the income approach
multi-period excess earnings method, which involves significant
unobservable inputs (Level 3 inputs). These inputs include
projected sales, margin, obsolescence factor, required rate of
return, and tax rate. Cash flows were discounted to their present
value as of the closing date. Developed technology is amortized on
a straight-line basis over its estimated useful life of 16
years.
The calculation of the excess purchase price over the estimated
fair value of the tangible net assets and intangible assets
acquired was recorded to goodwill, which is primarily attributed to
the acquired workforce expertise, the potential to enhance the
capabilities of current and future products, and expected research
and development synergies. The total goodwill related to this
combination is not deductible for tax purposes.
The total purchase price allocation is preliminary and based upon
estimates and assumptions that are subject to change within the
measurement period as additional information for the estimates is
obtained. The measurement period remains open pending the
completion of valuation procedures related to certain acquired
assets and liabilities assumed, primarily in connection with the
developed technology intangible asset.
Pro forma impact and results of operations disclosures have not
been included due to immateriality.
Acquisition-related costs were not material and have been recorded
within general and administrative expenses in the condensed
consolidated statement of operations. These costs include fees
associated with financial, legal, accounting, and other advisors
incurred to complete the merger.
PreventionGenetics LLC
On December 31, 2021, the Company completed the acquisition (the
“PreventionGenetics Acquisition”) of all of the outstanding equity
interests of PreventionGenetics, LLC. The PreventionGenetics
Acquisition provided the Company a Clinical Laboratory Improvement
Amendments (“CLIA”) certified and College of American Pathologist
(“CAP”) accredited sequencing lab based in Marshfield, Wisconsin.
PreventionGenetics provides more than 5,000 predefined genetic
tests for nearly all clinically relevant genes, additional custom
panels, and comprehensive germline, whole exome (“PGxome®”), and
whole genome (“PGnome®”) sequencing tests.
Refer to the Company’s 2021 10-K for detailed disclosures on the
combination, including the fair value of the consideration
transferred, purchase price allocation, and goodwill and intangible
assets identified in the transaction. During the three and six
months ended June 30, 2022, there were no material changes to
the purchase price and purchase price allocation. The measurement
period remains open pending the completion of valuation procedures
related to certain acquired assets and liabilities assumed,
primarily in connection with the intangible assets.
Ashion Analytics, LLC
On April 14, 2021, the Company completed the acquisition (“Ashion
Acquisition”) of all of the outstanding equity interests of Ashion
Analytics, LLC from PMed Management, LLC (“PMed”), which is a
subsidiary of TGen. The Ashion Acquisition provided the Company a
CLIA certified and CAP accredited sequencing lab based in Phoenix,
Arizona. Ashion developed the GEMExTra® test, a comprehensive
genomic cancer test, and provides access to whole exome, matched
germline, and transcriptome sequencing capabilities.
Refer to the Company’s 2021 10-K for detailed disclosures on the
combination, including the fair value of the consideration
transferred, purchase price allocation, and goodwill and intangible
assets identified in the transaction. During the three and six
months ended June 30, 2022, there were no changes to the
purchase price allocation and the measurement period has
closed.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Thrive Earlier Detection Corporation
On January 5, 2021, the Company completed the acquisition of all of
the outstanding capital stock of Thrive Earlier Detection
Corporation. Thrive, headquartered in Cambridge, Massachusetts, is
a healthcare company dedicated to incorporating earlier cancer
detection into routine medical care. The Company expects that
combining Thrive's early-stage multi-cancer early detection test
with the Company’s scientific platform, clinical organization and
commercial infrastructure will bring an accurate blood-based,
multi-cancer detection test to patients faster.
Refer to the Company’s 2021 10-K for detailed disclosures on the
combination, including the fair value of the consideration
transferred, final purchase price allocation, and goodwill and
intangible assets identified in the transaction.
Asset Acquisitions
PFS Genomics Inc.
On May 3, 2021, the Company acquired 90% of the outstanding capital
stock of PFS Genomics Inc. (“PFS”). On June 23, 2021, the Company
completed the acquisition of the remaining 10% interest in
PFS.
The Company expects this acquisition to expand its ability to help
guide early-stage breast cancer treatment through individualized
radiotherapy treatment decisions.
The transaction was treated as an asset acquisition under GAAP
because substantially all of the fair value of the gross assets
acquired were deemed to be associated with the acquired technology.
Refer to the Company’s 2021 10-K for detailed disclosures on the
asset acquisition, including the fair value of the consideration
transferred and purchase price allocation.
TARDIS License Agreement
On January 11, 2021, the Company entered into a worldwide exclusive
license to the proprietary TARDIS technology from TGen, an
affiliate of City of Hope. Under the agreement, the Company
acquired a royalty-free, worldwide exclusive license to proprietary
TARDIS patents and know-how. The Company intends to develop and
commercialize the TARDIS technology as a minimal residual disease
test.
The Company accounted for this transaction as an asset acquisition.
Refer to the Company’s 2021 10-K for detailed disclosures on the
asset acquisition, including the fair value of the consideration
transferred and information related to contingent
milestones.
(17) SEGMENT INFORMATION
Management determined that the Company functions as a single
operating segment, and thus reports as a single reportable segment.
This operating segment is focused on the development and global
commercialization of clinical laboratory services allowing
healthcare providers and patients to make individualized treatment
decisions. Management assessed the discrete financial information
routinely reviewed by the Company's Chief Operating Decision Maker,
its President and Chief Executive Officer, to monitor the Company's
operating performance and support decisions regarding allocation of
resources to its operations. Performance is continuously monitored
at the consolidated level to timely identify deviations from
expected results.
The following table summarizes total revenue from customers by
geographic region. Product revenues are attributed to countries
based on ship-to location.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
(In thousands) |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
United States |
|
$ |
493,299 |
|
|
$ |
407,971 |
|
|
$ |
950,427 |
|
|
$ |
783,992 |
|
Outside of United States |
|
28,341 |
|
|
26,848 |
|
|
57,784 |
|
|
52,904 |
|
Total revenues |
|
$ |
521,640 |
|
|
$ |
434,819 |
|
|
$ |
1,008,211 |
|
|
$ |
836,896 |
|
Long-lived assets located in countries outside of the United States
are not significant.
EXACT SCIENCES CORPORATION
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(18) INCOME TAXES
The Company recorded an income tax benefit of $1.8 million and an
income tax expense of $4.0 million for the three months ended June
30, 2022 and 2021, respectively. The Company recorded an income tax
benefit of $3.8 million and $238.8 million for the six months ended
June 30, 2022 and 2021, respectively. The Company’s income tax
benefit recorded during the three months ended June 30, 2022 is
primarily related to the future limitations on and expiration of
certain Federal and State deferred tax assets, offset by current
foreign and state tax expense. The Company’s income tax benefit
recorded during the six months ended June 30, 2022 is primarily
related to the future limitations on and expiration of certain
Federal and State deferred tax assets, offset by current foreign
and state tax expense. A deferred tax liability of approximately
$27.4 million was recorded as of June 30, 2022, which is
included in other long-term liabilities on the Company’s condensed
consolidated balance sheet. The Company continues to maintain a
full valuation allowance against its deferred tax assets based on
management’s determination that it is more likely than not the
benefit will not be realized.
The Company had $24.4 million and $21.8 million of unrecognized tax
benefits at June 30, 2022 and December 31, 2021,
respectively. These amounts have been recorded as a reduction to
the Company’s deferred tax asset, if recognized they would not have
an impact on the effective tax rate due to the existing valuation
allowance. Certain of the Company's unrecognized tax benefits could
change due to activities of various tax authorities, including
possible settlement of audits, or through normal expiration of
various statutes of limitations. The Company does not expect a
material change in unrecognized tax benefits in the next twelve
months.
As of June 30, 2022, due to the carryforward of unutilized net
operating losses and research and development credits, the Company
is subject to U.S. federal income tax e