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EXACT SCIENCE news // related to MDXhealth license Cologuard

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  1. NielsjeB 20 december 2015 15:16
    quote:

    andelopendeband schreef op 20 december 2015 11:49:

    Nielsje B.Het volume van EXAS eindigde afgelopen vrijdag op 8,642,827 door hoge omzetten bij nagenoeg het sluiten van de beurs en in de "after hours".
    Dat is zowat 10% van het totaal aantal aandelen,zonder een noemenswaardige
    invloed op de prijs.

    Heb jij hiervoor een verklaring?

    Zou dit kunnen duiden op een naderende eind beslissing van de USPSTF.
    Geen idee. Koersverloop was sowieso grillig, aan het begin van de dag stonden we zowat op +10%.

    Volgens mij vergadert de USPSTF pas weer ergens in maart. Zodra die beslissing er is merk je dat snel genoeg :)

    Ik hou de aandelen lekker vast. Mocht de boel verder inklappen, dan ga ik er nog eens over denken wat ik doe. Het kan hooguit naar nul, maar dat verwacht ik niet. De CMS reimbursement is immers nog steeds prima, dus Exact kan gewoon zijn testen blijven verkopen.
  2. andelopendeband 8 januari 2016 15:56
    quote:

    NielsjeB schreef op 8 januari 2016 12:16:

    Nagel aan de doodskist voor EXAS?

    DGAP-Adhoc: Epigenomics receives FDA notification about status of pending approval decision for Epi proColon(R)

    globenewswire.com/news-release/2016/0...
    Nielsje,ik heb de indruk dat dit de eerste 2-3 jaar nog geen bedreiging
    is voor EXAS.
    Heb jij enig idee wat zo'n test moet gaan kosten?
  3. NielsjeB 9 januari 2016 19:08
    quote:

    andelopendeband schreef op 8 januari 2016 15:56:

    [...]

    Nielsje,ik heb de indruk dat dit de eerste 2-3 jaar nog geen bedreiging
    is voor EXAS.
    Heb jij enig idee wat zo'n test moet gaan kosten?
    Dat zou zeker kunnen. Sterker nog, het is nog helemaal niet zeker dat de FDA goedkeuring verleent. In het verleden is het al eens "not approvable" verklaard door de FDA, zie bijv. www.genomeweb.com/clinical-genomics/f...

    Nu hebben ze extra data, en gaat de FDA het nogmaals bekijken. Ik persoonlijk denk dat de FDA het goed gaat keuren, juist omdat het een eenvoudig af te nemen test is. Wat de test moet kosten zou ik echt niet weten.
  4. [verwijderd] 11 januari 2016 19:33
    quote:

    NielsjeB schreef op 11 januari 2016 14:19:

    2015 Q4 / Full Year results EXAS:
    d1lge852tjjqow.cloudfront.net/CIK-000...
    Als alle resultaten zijn zoals beoogd door EXAS waarom dalen ze dan zo sterk?
    Als ze volgend jaar 90-100M USD omzetten, komen ze dan in de buurt van breakeven, of is dat dan nog heel ver weg?
  5. artm 11 januari 2016 22:07
    Al zelf gevonden:
    With the launch of licensee Exact Sciences' FDA-approval Cologuard test, MDxHealth expects to recognize a milestone fee and deferred license fees in excess of $0.5 million in the near term. In addition, pursuant to its license agreement with Exact Sciences, MDxHealth is eligible to receive minimum annual maintenance fees of $100,000 per year, sales milestones of $300,000 after Cologuard attains net sales of $10 million, $750,000 after Cologuard attains net sales of $50 million, and $1 million after Cologuard attains net sales of $50 million in a single calendar year, as well as running royalties in the mid-single digit range. The license agreement is expected to remain in effect until the last of the licensed patents expires in 2028.

    Zijn dat jaarlijkse bedragen of eenmalig?
    En is de payment van 50 miljoen al geweest? Zo nee, dan kunnen we komend jaar ieder geval 1.750.000 verwachten..
  6. kers 24 februari 2016 15:15
    104,000 completed Cologuard® tests generate revenues of $39.4 million during first full-year
    MADISON, Wis., Feb. 24, 2016 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company reported revenues of $39.4 million as a result of completing more than 104,000 Cologuard tests for full-year 2015. The company generated $14.4 million in revenues from approximately 38,000 completed Cologuard tests during the fourth quarter ended Dec. 31, 2015.
    The cumulative number of physicians ordering Cologuard expanded steadily in 2015. During the fourth quarter of 2015 this total grew 27 percent from the third quarter to nearly 27,000 physicians. On average, approximately 500 new physicians ordered Cologuard each week and 75 percent of physicians re-ordered the FDA-approved, non-invasive colon cancer screening test.
    "Our fourth quarter and full-year revenue and completed-test results are in line with the preliminary numbers we released in January and reflect the continued adoption and use of Cologuard," said Kevin T. Conroy, CEO and chairman of the board of Exact Sciences. "Patients and physicians showed strong demand for Cologuard and extraordinary satisfaction with its screening and compliance process during its first year on the market. We expect to build on this momentum during 2016 by educating an increasing number of America's primary care physicians about Cologuard and advancing our efforts to reach the 80 million people who need to be screened for colon cancer."
    The patient compliance rate with Cologuard at the end of 2015 was 71 percent. This is almost twice the rate of reported colonoscopy uptake in a given year and significantly higher than fecal blood testing. The compliance rate is derived from the number of valid test results generated from collection kits shipped to patients 60 or more days prior to Dec. 31, 2015. Exact Sciences Laboratories, through its customer care center, is helping to drive patient compliance by systematically contacting patients for whom Cologuard has been ordered and encouraging them to complete their screening.
    2016 Outlook
    The company continues to anticipate completing more than 240,000 Cologuard tests during 2016, generating between $90-100 million in revenue. This represents a greater than 130-percent year-over-year increase in the number of Cologuard tests completed and revenue growth of approximately 128 to 154 percent from 2015.
    "As commercial coverage expands, the Cologuard ordering process is streamlined and our sales and marketing efforts become increasingly impactful, we believe that adoption will increase at a meaningful rate during the year ahead," Mr. Conroy said.
    The company's guidance for revenue and completed tests are forward-looking statements. They are subject to various risks and uncertainties that could cause the company's actual results to differ materially from the anticipated targets. The anticipated targets are not predictions of the company's actual performance. See the cautionary information about forward-looking statements in the "Safe-Harbor Statement" section of this press release.
    Financial Results
    Exact Sciences reported total revenues of $14.4 million for the fourth quarter of 2015 and total revenues of $39.4 million for the year ended Dec. 31, 2015, compared to $1.5 million and $1.8 million, respectively, for the same periods of 2014.
    For the fourth quarter of 2015, Exact Sciences reported a net loss of $40.0 million, or ($0.41) per share. The company reported a net loss of $32.4 million, or ($0.38) per share, for the same period of 2014. The company's net loss for full-year 2015 totaled $157.8 million, or ($1.71) per share. The company reported a net loss of $100.0 million, or ($1.25) a share, for the same period of 2014.
    Operating expenses for the fourth quarter of 2015 were $47.2 million, compared to $30.7 million for the same period in 2014. Operating expenses for full-year 2015 totaled $174.0 million, compared to $98.0 million for full-year 2014.
    Exact Sciences ended 2015 with cash, cash equivalents and marketable securities of $306.9 million, compared to $282.8 million at December 31, 2014.
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