EXAS Exact Sciences Corporation

85.5
-1.19  -1%
Previous Close 86.69
Open 87.01
52 Week Low 35.2512
52 Week High 123.31
Market Cap $12,839,305,860
Shares 150,167,320
Float 146,282,151
Enterprise Value $13,490,494,970
Volume 1,180,401
Av. Daily Volume 1,348,498
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Drug Pipeline

Drug Stage Notes
Cologuard
Cancer - Colorectal DNA test
Approved
Approved
Approved August 2014

Latest News

  1. MADISON, Wis., Aug. 3, 2020 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ:EXAS) today announced that company management will participate in the following conference and invited investors to participate by webcast.

    • Canaccord Genuity Annual Growth Conference

      Fireside Chat on Wednesday, August 12, 2020, at 2:30 p.m. EDT

    The webcast can be accessed in the investor relations section of Exact Sciences' website at www.exactsciences.com.

    About Exact Sciences Corp.

    A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype DX, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this news release regarding our strategies, prospects, expectations, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement, and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the success of our efforts to facilitate patient access to Cologuard via telehealth; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition for our products and services; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively enter into and utilize strategic partnerships, such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; our ability to manage an international business and our expectations regarding our international expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to hedge such effects; the possibility that the anticipated benefits from our business acquisitions cannot be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of acquired businesses will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

    Contact:

    Megan Jones

    Exact Sciences Corp.



    608-535-8815

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/exact-sciences-to-participate-in-august-investor-conference-301104398.html

    SOURCE EXACT SCIENCES CORP

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  2. MADISON, Wis., July 30, 2020 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ:EXAS) today announced that the company generated revenue of $268.9 million for the second quarter ended June 30, 2020, compared to $199.9 million for the same period of 2019.

    "Cologuard helps solve the problem of COVID-related missed cancer screenings because it's a convenient, accurate, at-home test, and we believe this will accelerate adoption," said Kevin Conroy, Chairman and CEO. "COVID-19 is elevating the importance of our Precision Oncology tests, as patients and physicians look for smarter, faster answers to guide their cancer treatment decisions. As diagnostic testing continues to play a larger, more important role in cancer care, Exact Sciences is in a unique position to create value at every step along the way."

    Second Quarter 2020 Financial Results

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

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

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

    Non-GAAP Disclosure

    In addition to the company's financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company's operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

    Second Quarter Conference Call & Webcast

    Company management will host a conference call and webcast on Thursday, July 30, 2020, at 5 p.m. ET to discuss second quarter 2020 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-235-7650 and international callers should dial +1-647-689-4171. The access code for both domestic and international callers is 8183605.

    An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 8183605. The webcast, conference call and replay are open to all interested parties.

    About Cologuard

    Cologuard was approved by the FDA in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

    The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

    Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

    About Oncotype DX

    The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score® test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score® test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect™ test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

    About Exact Sciences Corp.

    A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype DX, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections.  Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms.  All statements other than statements of historical facts included in this news release regarding our strategies, prospects, expectations, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement, and the anticipated results of our product development efforts.  Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the success of our efforts to facilitate patient access to Cologuard via telehealth; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition for our products and services; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively enter into and utilize strategic partnerships, such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; our ability to manage an international business and our expectations regarding our international expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to hedge such effects; the possibility that the anticipated benefits from our business acquisitions cannot be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of acquired businesses will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

    Investor Contact:

    Megan Jones

    Exact Sciences Corp.



    608-535-8815

    Media Contact:

    Cara Connelly

    Exact Sciences Corp.



    608-284-5735

     

    EXACT SCIENCES CORPORATION

    Selected Unaudited Financial Information

    Condensed Consolidated Statements of Operations

    (Amounts in thousands, except per share data)











    Three Months Ended June 30,



    Six Months Ended June 30,



    2020



    2019



    2020



    2019

    Revenue

    $

    268,868





    $

    199,870





    $

    616,689





    $

    361,913



















    Operating expenses















    Cost of sales (exclusive of amortization of acquired intangible assets)

    77,892





    51,139





    159,498





    93,966



    Research and development

    32,673





    29,972





    76,182





    61,757



    Sales and marketing

    118,862





    88,190





    286,611





    179,129



    General and administrative

    106,685





    63,723





    220,676





    127,529



    Amortization of acquired intangible assets

    23,430





    748





    46,769





    1,508



    Total operating expenses

    359,542





    233,772





    789,736





    463,889



















    Other operating income

    23,665









    23,665







    Loss from operations

    (67,009)





    (33,902)





    (149,382)





    (101,976)



















    Other income (expense)















    Investment income, net

    2,912





    7,669





    3,009





    14,324



    Interest expense

    (22,912)





    (12,712)





    (48,065)





    (34,702)



    Total other income (expense)

    (20,000)





    (5,043)





    (45,056)





    (20,378)



















    Net loss before tax

    (87,009)





    (38,945)





    (194,438)





    (122,354)



















    Income tax benefit

    867





    443





    2,599





    913



















    Net loss

    $

    (86,142)





    $

    (38,502)





    $

    (191,839)





    $

    (121,441)



















    Net loss per share—basic and diluted

    $

    (0.58)





    $

    (0.30)





    $

    (1.29)





    $

    (0.95)



















    Weighted average common shares outstanding—basic and diluted

    149,727



    129,182



    148,938



    127,723

     

    EXACT SCIENCES CORPORATION

    Selected Unaudited Financial Information

    Condensed Consolidated Balance Sheets

    (Amounts in thousands)











    June 30, 2020



    December 31, 2019

    Assets







    Cash and cash equivalents

    $

    703,926





    $

    177,254



    Marketable securities

    518,731





    146,401



    Accounts receivable, net

    163,608





    130,667



    Inventory, net

    82,215





    61,724



    Prepaid expenses and other current assets

    36,378





    40,913



    Property, plant and equipment, net

    463,437





    455,325



    Operating lease right-of-use assets

    132,751





    126,444



    Goodwill

    1,237,672





    1,203,197



    Intangible assets, net

    1,105,115





    1,143,550



    Other long-term assets, net

    23,902





    20,293



    Total assets

    $

    4,467,735





    $

    3,505,768











    Liabilities and stockholders' equity







    Total current liabilities

    $

    222,274





    $

    236,494



    Convertible notes, net

    1,534,383





    803,605



    Long-term debt, less current portion

    22,944





    24,032



    Other long-term liabilities

    50,311





    34,911



    Operating lease liabilities, less current portion

    126,630





    118,665



    Total stockholders' equity

    2,511,193





    2,288,061



    Total liabilities and stockholders' equity

    $

    4,467,735





    $

    3,505,768



     

    EXACT SCIENCES CORPORATION

    Selected Unaudited Financial Information

    EBITDA and Adjusted EBITDA Reconciliations

    (Amounts in thousands)











    Three Months Ended June 30,



    Six Months Ended June 30,



    2020



    2019



    2020



    2019

    Net loss

    $

    (86,142)





    $

    (38,502)





    $

    (191,839)





    $

    (121,441)



    Interest expense

    22,912





    12,712





    40,111





    24,144



    Investment income

    (2,912)





    (7,669)





    (3,009)





    (14,324)



    Depreciation and amortization

    41,056





    7,880





    80,401





    15,015



    Income tax benefit

    (867)





    (443)





    (2,599)





    (913)



    EBITDA

    $

    (25,953)





    $

    (26,022)





    $

    (76,935)





    $

    (97,519)



    Stock-based compensation

    38,780





    20,143





    65,522





    36,309



    Loss on settlement of convertible notes









    7,954





    10,558



    Acquisition and integration costs (1)

    3,719









    11,768







    Reduction-in-force severance (2)

    2,198









    2,198







    CARES Act Funding (3)

    (23,665)









    (23,665)







    Adjusted EBITDA

    $

    (4,921)





    $

    (5,879)





    $

    (13,158)





    $

    (50,652)

















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











    (2) Represents severance costs as a result of proactive measures the Company put in place to address the impact of the COVID-19 pandemic. The severance cost resulting from this workforce reduction was $2.2 million for the three months and six months ended June 30, 2020.











    (3) As part of the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act"), the Company received $23.7 million from the United States Department of Health and Human Services Provider Relief Fund provided to eligible healthcare providers. The CARES Act funds are meant to offset the implications of the COVID-19 pandemic which include increases in the Company's costs and lost revenues.



     

    EXACT SCIENCES CORPORATION

    Selected Unaudited Financial Information

    Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations

    (Amounts in thousands)











    Three Months Ended June 30,



    Six Months Ended June 30,



    2020



    2019



    2020



    2019

    Revenue

    $

    268,868





    $

    199,870





    $

    616,689





    $

    361,913



    Cost of sales (exclusive of amortization of acquired intangible assets)

    77,892





    51,139





    159,498





    93,966



    Amortization of acquired intangible assets (1)

    20,555





    424





    41,018





    849



    Gross profit

    $

    170,421





    $

    148,307





    $

    416,173





    $

    267,098



    Gross margin

    63

    %



    74

    %



    67

    %



    74

    %

















    Amortization of acquired intangible assets (1)

    20,555





    424





    41,018





    849



    Non-GAAP gross profit

    $

    190,976





    $

    148,731





    $

    457,191





    $

    267,947



    Non-GAAP gross margin

    71

    %



    74

    %



    74

    %



    74

    %









    (1) Includes only amortization of intangible assets identified as developed technology assets through purchase accounting transactions, which otherwise would have been allocated to cost of sales.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/exact-sciences-announces-second-quarter-2020-results-301103473.html

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  3. MADISON, Wis., July 8, 2020 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ:EXAS) today announced that the company has scheduled its virtual annual stockholders meeting and second quarter 2020 earnings call.

    Annual Meeting of Stockholders Webcast Details

    Date:                    

    Thursday, July 23, 2020

    Time:  

    11 a.m. ET, 10 a.m. CT

    Webcast:

    The live webcast can be accessed at www.exactsciences.com

    The company plans to release its second quarter 2020 financial results after the close of the U.S. financial markets on July 30, 2020. Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

    Second Quarter 2020 Webcast & Conference Call Details

    Date:              

    Thursday, July 30, 2020

    Time:            

    5 p.m. ET, 4 p.m. CT

    Webcast:        

    The live webcast can be accessed at www.exactsciences.com

    Telephone:              

    Domestic callers, dial 833-235-7650 

    International callers, dial +1 647-689-4171

    Access code for both domestic and international callers: 8183605

    An archive of both webcasts will be available at www.exactsciences.com. A telephone replay of the second quarter 2020 conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 8183605. The webcast, conference call and replay are open to all interested parties.

    About Exact Sciences Corp.

    A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype DX, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections.  Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms.  All statements other than statements of historical facts included in this news release regarding our strategies, prospects, expectations, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement, and the anticipated results of our product development efforts.  Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the success of our efforts to facilitate patient access to Cologuard via telehealth; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition for our products and services; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively enter into and utilize strategic partnerships, such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; our ability to manage an international business and our expectations regarding our international expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to hedge such effects; the possibility that the anticipated benefits from our combination with Genomic Health cannot be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of Genomic Health's operations will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

    Investor Relations Contact:

    Megan Jones

    Exact Sciences Corp.



    608-535-8815

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  4. MADISON, Wis., June 16, 2020 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ:EXAS) today announced the publication of results highlighting the performance of the Oncotype DX Genomic Prostate Score® (GPS™) result in patients with unfavorable intermediate (UFI)-risk prostate cancer. Published in Urology, the new results demonstrate the GPS test is a strong independent predictor of critical outcomes in UFI-risk prostate cancer patients.

    "While men with very low-, low- and favorable intermediate-risk prostate cancer often choose between active surveillance and treatment, men with unfavorable intermediate-risk disease must make decisions about how aggressive their treatment plan should be," said Jennifer Cullen, Ph.D., M.P.H., lead author of the publication and Associate Director of Cancer Population Sciences at the Case Comprehensive Cancer Center in Cleveland. "These new findings, which demonstrate for the first time the GPS test as a strong predictor of critical endpoints in UFI-risk disease, indicate that Oncotype DX® testing can aid physicians and UFI-risk prostate cancer patients in their decision-making process. The GPS score may help in decisions regarding treatment intensity and empower patients in their care choices."

    For this new publication, additional statistical analyses were conducted of GPS results from two previously published cohort studies in men treated with radical prostatectomy. The study included 299 intermediate-risk patients, 175 of whom were classified as UFI-risk. Results showed that UFI-risk patients with a GPS test result >40 had outcomes consistent with high-risk disease and a poor prognosis, indicating they may benefit from more aggressive therapies. In contrast, UFI-risk patients with a GPS value <40 had outcomes similar to favorable intermediate-risk patients, suggesting less aggressive therapy may be needed.

    The GPS test has been shown in multiple studies to be a strong independent predictor of several critically important outcomes in men with very low, low, and favorable intermediate-risk prostate cancer. Findings from these new analyses support guideline inclusion of the GPS test in the broader population of UFI-risk patients.1

    "Men and families facing a prostate cancer diagnosis have many questions and tough decisions in determining the best course of treatment. Tools like the GPS test can help patients have confidence in navigating a treatment pathway," said Jamie Bearse, chief executive officer of ZERO - The End of Prostate Cancer. "This is an important step forward for expanding access and coverage for intermediate-risk prostate cancer patients, as they can use the GPS test to help best guide and determine their treatment."

    About the Oncotype DX Genomic Prostate Score® (GPS) Test

    Developed by Genomic Health, a wholly-owned subsidiary of Exact Sciences Corp., and based on results from multiple studies led by Cleveland Clinic and the University of California, San Francisco, the Oncotype DX® GPS test is the only genomic assay designed for men with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions at the time of diagnosis. The test analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide a GPS result with a score ranging from 0-100 that corresponds to the biologic aggressiveness of the tumor and the patient's likelihood of prostate cancer metastasis and death at 10 years. The GPS test is included within NCCN Guidelines® as a Category 2A molecular testing option for consideration in prostate cancer patients with clinically low-risk and favorable intermediate-risk disease and is covered by Medicare and multiple private insurance companies in the United States. To learn more about the Oncotype DX Genomic Prostate Score test, visit www.OncotypeIQ.com or www.MyProstateCancerTreatment.org.

    About Exact Sciences Corp.

    A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard® and Oncotype DX tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at  www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

    NOTE: In the US and certain other jurisdictions, Genomic Health, Oncotype, Oncotype DX, Oncotype IQ, Breast Recurrence Score, Recurrence Score, DCIS Score, Colon Recurrence Score, Genomic Prostate Score, GPS, AR-V7 Nucleus Detect, Pass It On: Until Every Woman Knows, and Making Cancer Care Smarter are trademarks of Genomic Health, Inc., an Exact Sciences corporation.

    Forward-Looking Statements

    This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this news release regarding our strategies, prospects, expectations, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement, and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: uncertainties associated with the coronavirus (COVID-19) pandemic, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the success of our efforts to facilitate patient access to Cologuard via telehealth; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition for our products and services; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively enter into and utilize strategic partnerships, such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; our ability to manage an international business and our expectations regarding our international expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to hedge such effects; the possibility that the anticipated benefits from our combination with Genomic Health cannot be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of Genomic Health's operations will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

    1 Cullen J, Kuo HC, Shan J, et al. The 17-Gene Genomic Prostate Score Test as a Predictor of Outcomes in Men with Unfavorable Intermediate Risk Prostate Cancer. Urol. 2020 (In Press)

    Investors:

    Media:

    Megan Jones

    Stephanie Spanos

    608-535-8815           

    608-556-4380

     

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  5. NEW YORK, June 15, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (NASDAQ:PAVM, PAVMZ))) (the "Company" or "PAVmed"), a highly differentiated, multiproduct medical device company, today announced that medical diagnostics pioneer Stanley Lapidus, founder and former Chairman and CEO of Exact Sciences (NASDAQ:EXAS), has joined its majority owned subsidiary, Lucid Diagnostics Inc. ("Lucid"), as a Strategic Advisor to assist with its commercial, regulatory, clinical trial and capital markets strategies.

    "I am thrilled to welcome Stan Lapidus as a Lucid Strategic Advisor and look forward to tapping into his vast wealth of knowledge, experience and wisdom as we advance EsoGuard and EsoCheck commercialization," said Lishan Aklog, M.D., PAVmed's Chairman and…

    NEW YORK, June 15, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (NASDAQ:PAVM, PAVMZ))) (the "Company" or "PAVmed"), a highly differentiated, multiproduct medical device company, today announced that medical diagnostics pioneer Stanley Lapidus, founder and former Chairman and CEO of Exact Sciences (NASDAQ:EXAS), has joined its majority owned subsidiary, Lucid Diagnostics Inc. ("Lucid"), as a Strategic Advisor to assist with its commercial, regulatory, clinical trial and capital markets strategies.

    "I am thrilled to welcome Stan Lapidus as a Lucid Strategic Advisor and look forward to tapping into his vast wealth of knowledge, experience and wisdom as we advance EsoGuard and EsoCheck commercialization," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer and Lucid's Executive Chairman. "Stan is a medical diagnostics industry titan and one of its most accomplished innovators in the early detection of cancer and its precursors, including cervical and colon cancer. Since its inception, Lucid's stated goal has been for its early detection technologies to have as great an impact on preventing esophageal cancer as widespread Pap testing has had in preventing cervical cancer. We are fortunate that one of the most impactful persons in preventing deaths from cervical cancer will be helping us achieve this mission."

    "I have spent most of my professional career in a quest to save lives through the early detection of cancer and its precursors," said Mr. Lapidus. "Lucid Diagnostics' EsoGuard and EsoCheck technologies have the potential to be game changers in the diagnosis of conditions along the spectrum from Barrett's Esophagus to esophageal cancer, which is a growing scourge. The ability to noninvasively screen at-risk patients for these conditions has substantial clinical and commercial potential. The Lucid team is poised to reach key inflection points and I look forward to working with them as they accelerate commercialization, embark on important IVD clinical trials and explore capital market strategies."

    Mr. Lapidus brings more than three decades of experience founding and leading breakthrough diagnostic companies. He founded and served as President of Cytyc Inc., whose ThinPrep® Pap test technology which he invented, revolutionized early detection of cervical cancer. Cytyc was acquired by Hologic Inc. in 2007 for $6.2 billion. Mr. Lapidus also founded and served as President & CEO and later as Chairman of Exact Sciences, whose Cologuard® stool DNA test has revolutionized early detection of colorectal cancer. Exact Sciences became the fastest growing company in the history of the diagnostics industry and now is a leading provider of cancer screening and diagnostic tests, with a market cap over $12 billion. Mr. Lapidus also founded and led medical diagnostic companies Helicos BioSciences Inc. and SynapDx Inc. He currently serves on the Board of Directors of Binx Health Inc., Glympse Bio Inc., PathAI Inc, Fractyl Laboratories Inc. and T2 Biosystems Inc. He also serves as a Co-Founding Pillar of Pillar VC, Managing Director of his own incubator LapidDx Research, has served as an Instructor at the Massachusetts Institute of Technology and is Fellow of the American Institute of Medical and Biological Engineering.

    About Lucid

    Lucid Diagnostics Inc. is a highly differentiated, medical device innovator with products designed to diagnose and treat conditions of the esophagus. Lucid's EsoGuard Esophageal DNA Test and EsoCheck Collection Device are designed to facilitate the diagnosis of Barrett's Esophagus (BE) and related precursors to highly lethal esophageal adenocarcinoma (EAC) in patients with chronic heart burn, also known as gastroesophageal reflux disease (GERD). 

    EsoGuard is commercially available in the United States as a Laboratory Developed Test (LDT) and is the first DNA test designed to facilitate the diagnosis of Barrett's Esophagus (BE) and related precursors to highly lethal esophageal adenocarcinoma (EAC). EsoGuard is performed on cells sampled from the lower esophagus in a five-minute noninvasive office-based procedure. Next-generation sequencing (NGS) of DNA extracted from these cells is used to determine the epigenetic methylation status of 31 sites on two genes (VIM and CCNA1). A positive or negative result is determined based on algorithmic assessment of the percentage of DNA molecules for which a proportion of methylated sites on either gene exceeds a certain threshold. A positive result has been correlated, with greater than 90% sensitivity and specificity, with the presence of non-dysplastic BE, dysplastic BE or EAC, in a clinical study of 408 patients published in Science Translational Medicine.

    The EsoCheck Collection Device is an FDA 510(k)-cleared non-invasive cell collection device designed to sample cells from the esophagus in a five-minute office-based procedure, without the need for endoscopy – the only such device capable of doing so in an anatomically targeted fashion without sample dilution or contamination (EsoCheck animation). Patients swallow a vitamin pill-sized capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs surface cells from the target area and protects them as the device is removed. The sampled cells can then be subjected to any commercially available diagnostic test, including EsoGuard. EsoCheck is also being evaluated to assist in monitoring BE disease progression and in the diagnosis and management of Eosinophilic Esophagitis (EoE), a rapidly emerging allergy-mediated inflammatory condition of the esophagus similar to, and often associated with, inflammatory bowel disease (IBD).

    About PAVmed

    PAVmed Inc. is a highly differentiated, multiproduct commercial stage medical device company employing a unique business model designed to advance innovative products to commercialization rapidly and with less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed's diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard™ Esophageal DNA Test, EsoCheck™ Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX™ Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Infusion Platform Technology), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn.

    Forward-Looking Statements

    This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed's common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed's preclinical studies; whether and when PAVmed's products are cleared by regulatory authorities; market acceptance of PAVmed's products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company's financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed's control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed's future operations, see Part I, Item IA, "Risk Factors," in PAVmed's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Reports on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

    Contacts:

    Investors

    Mike Havrilla

    Director of Investor Relations

    (814) 241-4138

    Media

    Shaun O'Neil

    Chief Commercial Officer

    (518) 812-3087

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