Exact Sciences Announces Second-Quarter 2023 Results
- Exact Sciences Corp. achieved record results in the second quarter of 2023, with total revenue of $622 million, representing a 19% increase compared to the same period in 2022.
- The company generated positive free cash flow of $66 million during the second quarter.
- Exact Sciences raised its full-year revenue guidance by $54 million and adjusted EBITDA guidance by $63 million at the midpoints.
- The company anticipates revenue of $2.441-$2.466 billion for 2023, higher than the previously expected range of $2.380-$2.420 billion.
- Screening revenue, which includes laboratory service revenue from Cologuard® tests and PreventionGenetics, increased by 31% to $462.8 million.
- Precision Oncology revenue, which includes laboratory service revenue from global Oncotype DX® products and therapy selection products, increased by 2% to $157.2 million.
- COVID-19 testing revenue decreased by 84% to $2.1 million.
- Gross margin including amortization of acquired intangible assets was 71%, and non-GAAP gross margin excluding amortization of acquired intangible assets was 75%.
- The company's net loss decreased to $81.0 million, compared to a net loss of $166.1 million in the same period of 2022.
- Exact Sciences ended the quarter with $775.7 million in cash, cash equivalents, and marketable securities.
- None.
Reports record results, generates positive free cash flow, raises full-year guidance
Second-quarter 2023 highlights
- Total second quarter revenue of
, an increase of$622 million 19% , and of core revenue, an increase of$617 million 24% - Cash provided by operating activities was
and free cash flow was$100 million $66 million - Full-year 2023 revenue and adjusted EBITDA guidance raised by
and$54 million at the midpoints, respectively$63 million
"The team at Exact Sciences is powering the most innovative growth engine in cancer diagnostics," said Kevin Conroy, chairman and CEO. "Led by our best-in-class scientific team, we'll continue to enhance our current tests and develop new tests that help meaningfully improve patient outcomes. The second-quarter results demonstrate how our scale and commercial teams will help those tests impact millions of patients while improving profitability."
Second-quarter 2023 financial results
For the three-month period ended June 30, 2023, as compared to the same period of 2022 (where applicable):
- Total revenue was
, an increase of 19 percent$622.1 million - Core revenue was
, an increase of 24 percent$617.5 million - Screening revenue was
, an increase of 31 percent$462.8 million - Precision Oncology revenue was
, an increase of 2 percent, or 7 percent on a core revenue basis$157.2 million - COVID-19 testing revenue was
, a decrease of 84 percent$2.1 million - Gross margin including amortization of acquired intangible assets was 71 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 75 percent
- Net loss was
, or$81.0 million per share, compared to a net loss of$0.45 , or$166.1 million per share$0.94 - EBITDA was
and adjusted EBITDA was$(21.7) million $66.9 million - Cash provided by operating activities was
and free cash flow was$100.4 million $65.7 million - Cash, cash equivalents, and marketable securities were
at the end of the quarter$775.7 million
Screening primarily includes laboratory service revenue from Cologuard® tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX® products and therapy selection products.
2023 outlook
The company anticipates revenue of
- Screening revenue of
,$1.82 0-$1.83 5 billion - Precision Oncology revenue of
, and$615 -$625 million - COVID-19 testing revenue of
.$6 million
Revenue guidance has been raised from the previously expected range of
- Screening revenue of
,$1.77 0-$1.79 5 billion - Precision Oncology revenue of
, and$605 -$620 million - COVID-19 testing revenue of
.$5 million
Second-quarter 2023 conference call & webcast
Company management will host a conference call and webcast on Tuesday, August 1, 2023, at 5 p.m. ET to discuss second-quarter 2023 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.
An archive of the webcast will be available at exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.
Non-GAAP disclosure
In addition to the company's financial results determined in accordance with
About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.
About Exact Sciences' Precision Oncology portfolio
Exact Sciences' Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score® test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra™ test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. To learn more, visit precisiononcology.exactsciences.com.
About PreventionGenetics
Founded in 2004 and located in
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.
Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results; expectations for development of new or improved products and services and their impact on patients; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated benefits of our acquisitions, including estimated synergies and other financial impacts.
Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; our reliance upon certain suppliers, including suppliers that are the sole source of certain products; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition for our products and services; the effects of any judicial, executive or legislative action affecting us or the healthcare system; recommendations, guidelines and quality metrics issued by various organizations regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively enter into and utilize strategic partnerships and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; the results of our validation studies and clinical trials, including the risks that the results of future studies and trials may differ materially from the results of previously completed studies and trials; our ability to manage an international business and our expectations regarding our international expansion and opportunities; our ability to raise the capital necessary to support our operations or meet our payment obligations under our indebtedness; the potential effects of changing macroeconomic conditions, including the effects of inflation and interest rate and foreign currency exchange rate fluctuations and any such efforts to hedge such effects; our ability to efficiently and flexibly manage our business amid uncertainties related to the coronavirus ("COVID-19") pandemic; the possibility that the anticipated benefits from our business acquisitions will not be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of acquired businesses' operations or the divestiture of business operations will be greater than expected and the possibility that integration or divestiture efforts will disrupt our business and strain management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; our ability to retain and hire key personnel; and the impact of labor shortages, turnover, and labor cost increases. The risks included above are not exhaustive. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
EXACT SCIENCES CORPORATION Selected Unaudited Financial Information Condensed Consolidated Statements of Operations (Amounts in thousands, except per share data) | |||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
Revenue | $ 622,093 | $ 521,640 | $ 1,224,543 | $ 1,008,211 | |||
Operating expenses | |||||||
Cost of sales (exclusive of amortization of acquired intangible assets) | 156,991 | 144,600 | 313,857 | 279,305 | |||
Research and development | 104,095 | 106,083 | 199,514 | 208,331 | |||
Sales and marketing | 176,490 | 215,922 | 363,454 | 448,103 | |||
General and administrative | 237,965 | 181,672 | 455,260 | 351,442 | |||
Amortization of acquired intangible assets | 22,929 | 26,356 | 45,857 | 51,010 | |||
Impairment of long-lived assets | 552 | 6,591 | 621 | 6,591 | |||
Total operating expenses | 699,022 | 681,224 | 1,378,563 | 1,344,782 | |||
Loss from operations | (76,929) | (159,584) | (154,020) | (336,571) | |||
Other income (expense) | |||||||
Investment income (loss), net | 4,828 | (3,719) | 5,318 | (5,206) | |||
Interest expense | (7,818) | (4,511) | (3,711) | (8,989) | |||
Total other income (expense) | (2,990) | (8,230) | 1,607 | (14,195) | |||
Net loss before tax | (79,919) | (167,814) | (152,413) | (350,766) | |||
Income tax benefit (expense) | (1,107) | 1,751 | (2,764) | 3,766 | |||
Net loss | $ (81,026) | $ (166,063) | $ (155,177) | $ (347,000) | |||
Net loss per share—basic and diluted | $ (0.45) | $ (0.94) | $ (0.87) | $ (1.98) | |||
Weighted average common shares outstanding—basic and diluted | 180,204 | 176,364 | 179,393 | 175,396 |
EXACT SCIENCES CORPORATION Selected Unaudited Financial Information Condensed Consolidated Balance Sheets (Amounts in thousands) | |||
June 30, 2023 | December 31, 2022 | ||
Assets | |||
Cash and cash equivalents | $ 604,363 | $ 242,493 | |
Marketable securities | 171,349 | 389,564 | |
Accounts receivable, net | 178,317 | 158,043 | |
Inventory | 130,770 | 118,259 | |
Prepaid expenses and other current assets | 89,129 | 73,898 | |
Property, plant and equipment, net | 686,602 | 684,756 | |
Operating lease right-of-use assets | 148,690 | 167,003 | |
Goodwill | 2,346,248 | 2,346,040 | |
Intangible assets, net | 1,910,559 | 1,956,240 | |
Other long-term assets, net | 89,536 | 90,577 | |
Total assets | $ 6,355,563 | $ 6,226,873 | |
Liabilities and stockholders' equity | |||
Current liabilities | $ 488,057 | $ 412,747 | |
Convertible notes, net | 2,311,567 | 2,186,106 | |
Long-term debt, less current portion | — | 50,000 | |
Other long-term liabilities | 330,816 | 352,459 | |
Operating lease liabilities, less current portion | 168,501 | 182,399 | |
Total stockholders' equity | 3,056,622 | 3,043,162 | |
Total liabilities and stockholders' equity | $ 6,355,563 | $ 6,226,873 |
EXACT SCIENCES CORPORATION Selected Unaudited Financial Information Reconciliation of Core Revenue (Amounts in thousands) | ||||||||||||
GAAP | ||||||||||||
Three Months Ended June 30, | ||||||||||||
2023 | 2022 | % Change | ||||||||||
Screening | $ 462,787 | $ 353,894 | 31 % | |||||||||
Precision Oncology | 157,174 | 153,995 | 2 % | |||||||||
COVID-19 Testing | 2,132 | 13,751 | (84) % | |||||||||
Total | $ 622,093 | $ 521,640 | 19 % | |||||||||
Non-GAAP | ||||||||||||
Three Months Ended June 30, | ||||||||||||
2023 (1) | 2022 (1) | % Change | Foreign | Core Revenue (3) | % Change (3) | |||||||
Screening | $ 462,787 | $ 353,894 | 31 % | $ — | $ 462,787 | 31 % | ||||||
Precision Oncology | 154,884 | 144,450 | 7 % | (198) | 154,686 | 7 % | ||||||
Total | $ 617,671 | $ 498,344 | 24 % | $ (198) | $ 617,473 | 24 % | ||||||
GAAP | ||||||||||||
Six Months Ended June 30, | ||||||||||||
2023 | 2022 | % Change | ||||||||||
Screening | $ 905,982 | $ 660,416 | 37 % | |||||||||
Precision Oncology | 312,606 | 306,615 | 2 % | |||||||||
COVID-19 Testing | 5,955 | 41,180 | (86) % | |||||||||
Total | $ 1,224,543 | $ 1,008,211 | 21 % | |||||||||
Non-GAAP | ||||||||||||
Six Months Ended June 30, | ||||||||||||
2023 (1) | 2022 (1) | % Change | Foreign | Core Revenue (3) | % Change (3) | |||||||
Screening | $ 905,982 | $ 660,416 | 37 % | $ — | $ 905,982 | 37 % | ||||||
Precision Oncology | 308,275 | 288,102 | 7 % | 1,094 | 309,369 | 7 % | ||||||
Total | $ 1,214,257 | $ 948,518 | 28 % | $ 1,094 | $ 1,215,351 | 28 % |
(1) Excludes revenue from the divested Oncotype DX Genomic Prostate Score test and COVID-19 testing. |
(2) Foreign currency impact is calculating the change in current period non- |
(3) Excludes revenue from the divested Oncotype DX Genomic Prostate Score test and COVID-19 testing, as well as the impact of foreign currency exchange rate fluctuations. |
EXACT SCIENCES CORPORATION Selected Unaudited Financial Information Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations (Amounts in thousands) | ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
2023 | 2022 | 2023 | 2022 | |||||
Revenue | $ 622,093 | $ 521,640 | $ 1,224,543 | $ 1,008,211 | ||||
Cost of sales (exclusive of amortization of acquired intangible assets) | 156,991 | 144,600 | 313,857 | 279,305 | ||||
Amortization of acquired intangible assets (1) | 20,718 | 22,477 | 41,435 | 44,954 | ||||
Gross profit | $ 444,384 | $ 354,563 | $ 869,251 | $ 683,952 | ||||
Gross margin | 71 % | 68 % | 71 % | 68 % | ||||
Amortization of acquired intangible assets (1) | 20,718 | 22,477 | 41,435 | 44,954 | ||||
Non-GAAP gross profit | $ 465,102 | $ 377,040 | $ 910,686 | $ 728,906 | ||||
Non-GAAP gross margin | 75 % | 72 % | 74 % | 72 % |
(1) Includes only amortization of intangible assets identified as developed technology assets through purchase accounting transactions, which otherwise would have been allocated to cost of sales. |
EXACT SCIENCES CORPORATION Selected Unaudited Financial Information EBITDA and Adjusted EBITDA Reconciliations (Amounts in thousands) | ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
(In thousands) | 2023 | 2022 | 2023 | 2022 | ||||
Net loss | $ (81,026) | $ (166,063) | $ (155,177) | $ (347,000) | ||||
Interest expense (1) | 7,818 | 4,511 | 3,711 | 8,989 | ||||
Depreciation and amortization | 50,439 | 51,861 | 100,182 | 99,508 | ||||
Income tax (benefit) expense | 1,107 | (1,751) | 2,764 | (3,766) | ||||
EBITDA | $ (21,662) | $ (111,442) | $ (48,520) | $ (242,269) | ||||
Stock-based compensation (2) | 70,766 | 64,494 | 132,663 | 129,975 | ||||
Investment loss (income) | (4,828) | 3,719 | (5,318) | 5,206 | ||||
Acquisition and integration costs (3) | 4,773 | (23,742) | (3,751) | (49,703) | ||||
Reduction-in-force severance (4) | — | 14,613 | 907 | 14,613 | ||||
Impairment of long-lived assets (5) | 552 | 6,591 | 621 | 6,591 | ||||
Legal settlement (6) | 17,250 | — | 36,186 | — | ||||
Adjusted EBITDA | $ 66,851 | $ (45,767) | $ 112,788 | $ (135,587) |
(1) Interest expense for the six months ended June 30, 2023, includes a |
(2) Represents stock-based compensation expense and 401(k) match expense as the Company matches a portion of Exact Sciences employees' contributions annually in the form of the Company's common stock. |
(3) Represents acquisition and related integration costs incurred as a result of the Company's business combinations and asset acquisitions. This includes fees for professional services and the remeasurement of the contingent consideration liabilities in connection with business combinations. For the three and six months ended June 30, 2023, this includes a loss of |
(4) Represents severance and legal fees incurred by the Company's international operations in 2023 as a result of proactive measures the Company put in place to address the impact of the inflationary environment and other macroeconomic trends in the fourth quarter of 2022. |
(5) Represents impairment charges on the Company's long-lived assets. For the three and six months ended June 30, 2023, the Company recorded insignificant impairments to building leases that were vacated during the year. |
(6) The Company reached agreements in principle with the counterparties related to the Medicare Date of Service Rule Investigation ("DOS Rule Matter") and the Federal Anti-Kickback Statute and False Claims Act qui tam lawsuit in the second quarter of 2023, which are accrued as of June 30, 2023. The Company previously accrued |
EXACT SCIENCES CORPORATION Selected Unaudited Financial Information Condensed Consolidated Statements of Cash Flows and Reconciliation of Free Cash Flow (Amounts in thousands) | ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
2023 | 2022 | 2023 | 2022 | |||||
Net cash provided by (used in) operating activities | $ 100,424 | $ (60,916) | $ 62,209 | $ (234,670) | ||||
Net cash provided by investing activities | 66,474 | 21,659 | 149,415 | 67,220 | ||||
Net cash provided by financing activities | 16,041 | 63,412 | 149,637 | 66,147 | ||||
Effects of exchange rate changes on cash and cash equivalents | 59 | (510) | 609 | (747) | ||||
Net increase (decrease) in cash, cash equivalents and restricted cash | 182,998 | 23,645 | 361,870 | (102,050) | ||||
Cash, cash equivalents and restricted cash, beginning of period | 421,662 | 190,073 | 242,790 | 315,768 | ||||
Cash, cash equivalents and restricted cash, end of period | $ 604,660 | $ 213,718 | $ 604,660 | $ 213,718 | ||||
Reconciliation of free cash flow: | ||||||||
Net cash provided by (used in) operating activities | $ 100,424 | $ (60,916) | $ 62,209 | $ (234,670) | ||||
Purchases of property, plant and equipment | (34,721) | (63,326) | (64,081) | (96,949) | ||||
Free cash flow | $ 65,703 | $ (124,242) | $ (1,872) | $ (331,619) |
Investor Contact:
Megan Jones
Exact Sciences Corp.
meganjones@exactsciences.com
608-535-8815
Media Contact:
Morry Smulevitz
Exact Sciences Corp.
msmulevitz@exactsciences.com
608-345-8010
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SOURCE Exact Sciences Corporation
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