main office: Madison, wi


general manager:
Meet Pat Setji

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Product: Cologuard

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Cologuard is the first and only FDA approved, non-invasive,multi-target, stool-based colorectal cancer screening test. There are 106 million Americans at average risk for colorectal cancer who should be screened regularly. Today, an estimated 46 million of them are not up to date with screening recommendations. Cologuard has helped screen more than 5 million people since it was made available and has captured about 5 percent of the addressable market. Our long-term goal is to help meaningfully impact colon cancer screening rates, eradicate this terrible disease, and capture at least 40% of the market with Cologuard, which equates to about $7 billion in annual revenue.

Source: Exact Sciences estimates

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Sales and marketing Strength

The commercial organization supporting our Screening business is uniquely positioned within screening and diagnostics. Our field sales representatives have relationships spanning across primary care, gastroenterology, women’s health, and large health systems. We have experienced marketing and medical affairs teams to lead our brand growth and education efforts. In 2020, we optimized promotion of Cologuard® by expanding the marketing team with experienced leaders and diversifying the promotional channels in which we engage with health systems.

At the start of the pandemic, we quickly adapted by leveraging our inside sales model to reach providers remotely. We devoted significant online patient education resources toward the ability to request Cologuard online through telehealth providers. We continue to have strong market access with the majority of patients paying $0 for Cologuard. Our nationwide consumer marketing campaigns have continued driving consumer awareness of Cologuard and requests for Cologuard to healthcare providers. We’ve also been developing a deeper understanding of our customers, and in 2020, used this knowledge to inform new marketing campaigns both for consumers and providers.

We have an unsurpassed national navigation program, which helps patients complete the screening process. Our goal is to ensure that colon cancer screening is as easy and comfortable as possible.Our experienced customer care team is available 24/7 to support patients and answer questions about completing the Cologuard test.

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Growth opportunities

In the near-term, we expect our sales and marketing initiatives to continue to drive Cologuard growth. We also see health information technology continuing to be an important growth opportunity.  We have made it easier for providers to order Cologuard and receive results through interfaces that are fully integrated into their health record system.

We see several mid-term and long-term growth drivers that can help achieve our 40% market share goal. In late 2019, Cologuard’s label expanded to include 19 million average-risk Americans ages 45-49.  This FDA label expansion has widened our opportunity to impact the rising incidence of colorectal cancer in younger adults. Several medical guidelines have endorsed screening beginning at age 45 for average risk people. We also see the utilization of Cologuard for patient rescreening as a key growth opportunity. Patients who receive a negative screening result with Cologuard are dueto be screened again in 3 years, according to medical guidelines. We have several programs in place to help patients stay current with screening and get screened again when they are due. Longer term, we're developing an enhanced version of Cologuard to further differentiate it as an effective screening test. We’re also developing a blood-based colon cancer test to offer another option for patients to get screened.

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Screening with Cologuard changed the course of my life. The work Exact Sciences does matters so much to people – thank you for what you do.”

Patient Story

At 53 years old, Scott had a list of reasons he put off screening for colon cancer. He was worried about the bowel prep and invasive nature of a colonoscopy. Scott also felt healthy and took care of himself by exercising and eating right, so he did not understand why he needed to prioritize screening.

In February 2020, Scott attended the Cologuard Classic in Tucson, Arizona, where he learned about Cologuard. He liked that Cologuard was an easy test he could use at home that would allow him to get screened without taking time out of his busy schedule to go in for an invasive procedure.

During a routine visit to his healthcare provider, Scott and his doctor decided Cologuard was the right screening option for him. Scott felt comfortable using Cologuard, especially because it was the middle of the COVID-19 pandemic and he could use the test from the safety of his own home. He received a positive result from his Cologuard test, and during his follow-up colonoscopy, a tumor was found. After having surgery, he found out it was stage I colon cancer. Scott admitted the days following surgery were some of the hardest as he worried what his diagnosis meant for himself and his family.

Scott underwent treatment for his cancer. When he went back for a follow-up several months later, his doctor found no signs of disease.

Forward-Looking Statements

This report 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 report regarding our strategies, prospects, expectations, goals, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected growth opportunities and market share, 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 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.