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Exact Sciences Idea Proposal (EXAS)

Exact Sciences Idea Proposal (EXAS)
 

How much runway is left for EXAS’ Cologuard test as it kicks off its joint sales and marketing agreement with Pfizer?

Report Available: February 15, 2019

 

Blueshift’s initial research found EXAS producing stellar Q4 and full-year results for its Cologuard test while entering a sales and marketing agreement with PFE aimed at continuing its growth trajectory. Obstacles are emerging, however, which may slow Cologuard’s growth, including the development of liquid biopsies by many competitors which could become the screening test of choice because of its easier process for providing blood. The recent approval of a new cancer screening test from 23andMe could serve to help or harm Cologuard.

 

Observations

  1. EXAS released impressive preliminary and unaudited Q4 and full-year results in early January. Revenue was up 64% compared to Q4 2017. Full-year revenue growth was 71% and Cologuard test volume reached 934,000 tests, a 64% increase from 2017.  The number of healthcare providers that have ordered a Cologuard test since its launch in 2014 now totals nearly 147,000, up from 121,000 at the end of the second quarter.
  2. In August 2018, EXAS and PFE announced a sales and marketing agreement to promote Cologuard. The four-year deal calls for PFE sales reps to make 143,000 sales pitches in Q4 2018 and a total of 625,000 presentations per year. In addition, PFE will share in gross profits and marketing expenses.
  3. EXAS claims a strong pipeline. The company is testing its Cologuard products on the 45-year-old population which, if successful and approved by the FDA, will significantly expand the addressable market for the test. The pipeline also includes liquid biopsy liver and lung cancer blood tests which are currently in clinical trial.
  4. A liquid biopsy is a blood test screening for cancer and is quicker than a surgical biopsy. This non-invasive process is also likely, in the case of screening for colorectal cancer, to be preferred over delivering a sample like with Cologuard, and could significantly slow demand for EXAS’ primary revenue producer. Competitors such as ILMN, RHHB, NTRA, TMO, GHDX, and GH are all working on what’s believed to become the holy grail for cancer testing. Of course, EXAS is developing its own liquid biopsy tests as well.
  5. Another development to potentially affect Cologuard’s market is the recent FDA approval of 23andMe’s new cancer test which offers risk assessments for colorectal cancer and could affect Cologuard negatively as another competitor or positively if it pushes more patients to request the EXAS cancer screening.
  6. Blueshift Research has been researching EXAS’ Cologuard since Aug. 14, 2015 where we found that Cologuard would become the preferred test for one-third of the 50-and-over patients refusing the standard colonoscopy. We again saw growth potential for Cologuard in our Aug. 31, 2016, report. Cologuard’s inclusion in the 2017 Healthcare Effectiveness Data and Information Set (HEDIS) was expected to contribute to increased test usage and additional third-party reimbursement.

 

How has the sales and marketing agreement between EXAS and PFE affected Cologuard sales? How much runway is left for Cologuard? What are the headwinds that could curtail Cologuard’s growth? How significant will it be for EXAS to gain approval for its Cologuard test to available for 45- to 49-year-olds? What is the latest on liquid biopsies? How will this affect Cologuard? Will the 23andMe cancer test help or hurt Cologuard? To answer these and other questions, Blueshift will gather data and issue a market research report from independent sources in the following areas: Medical professionals prescribing Cologuard, Medical professionals that are not prescribing Cologuard, Third-party payers/insurers, and Industry specialists.

 

Companies: Exact Sciences (EXAS), Boston Scientific (BSX), Illumina (ILMN), Roche (RHHBY), Genomic Health (GHDX), Guardant Health (GH), Natera (NTRA), Thermo Fisher Scientific (TMO), Medigus (MDGS), Check-Cap Ltd. (CHEK), VolitionRX Ltd. (VNRX)

 

Research Begins: February 5, 2019

 

 

 

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