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MDX Health 2019

520 Posts
Pagina: «« 1 ... 19 20 21 22 23 ... 26 »» | Laatste | Omlaag ↓
  1. Pelikapuntzak 25 augustus 2019 13:16
    quote:

    fly like an eagle schreef op 25 augustus 2019 11:53:

    Ben benieuwd of de nieuwe CEO wat positiefs te melden heeft maar het is inderdaad angstvallig stil. Insiders hebben nog niet verkocht maar willen -net als ik- hun verlies nog niet nemen (?).
    Je verlies zal dan serieus zijn, je zat al in MDX in de 4/5/6€ zone.
  2. [verwijderd] 26 augustus 2019 09:14
    MDxHealth (R): MDxHealth Announces Favorable Draft Medicare Coverage for the SelectMDx Test

    08/26/2019 | 01:00am EDT

    IRVINE, CA – August 26, 2019 – MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies under its MolDx program, has issued a draft local coverage determination (LCD) for the SelectMDx® for Prostate Cancer test. The draft LCD recommends coverage of the test for qualified Medicare patients throughout the United States.

    “We are pleased that Medicare has taken this important step toward providing coverage for SelectMDx — a test that can help improve the disposition of men at risk for aggressive prostate cancer,” stated Michael McGarrity, CEO of MDxHealth. “It is a vital step toward ensuring all Medicare patients will have access to the highest quality and accurate prostate cancer risk assessment.” The company will provide further comment in its Mid-Year 2019 Results scheduled for August 29, 2019.

    The proposed LCD policy can be accessed on the CMS website.

    About SelectMDx® for Prostate Cancer

    Of the nearly 2 million prostate biopsies performed each year, less than a third identify cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive liquid biopsy method to assess a patient’s risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 95% for clinically significant disease, helping to reduce the need for invasive prostate biopsies, thereby reducing healthcare costs. The test has been included in the 2018 European Association of Urology (EAU) clinical guidelines.
  3. Pat2000 26 augustus 2019 13:14
    De Amerikaanse zorgverzekeraar Palmetto GBA adviseert in een concept-oordeel om de prostaatkankertest van MdxHealth te vergoeden voor patiënten onder het Medicare-zorgstelsel. Dat maakte MDxHealth maandag bekend.
    "We zijn verheugd dat Medicare deze belangrijke stap heeft genomen naar het bieden van dekking voor SelectMDx", stelde CEO Michael McGarrity van MDXHealth. "Het is een cruciale stap op weg naar het bieden van de zekerheid dat alle Medicare-patiënten toegang zullen hebben tot de prostaatkankertest van de hoogste kwaliteit."
    Palmetto heeft een programma dat moleculaire diagnostische technologieën beoordeelt.
    MDxHealth zal bij zijn halfjaarcijfers donderdag het nieuws verder toelichten.
  4. forum rang 4 vreemdvermogen 26 augustus 2019 18:40
    Ruim 700K omzet vandaag. Waar komen die vandaan? Nou gewoon van de grootaandeelhouders, die willen laten zien dat MDx een gewild aandeel is. Zij willen er zelf graag van af. 99% vestzak broekzak handel. Een enkele gek die koopt. MDx moet donderdag echt laten zien dat er nog muziek in de tent zit. Ik geloof er (al lang) niet meer in.
  5. [verwijderd] 27 augustus 2019 13:44
    ik hoop ze terug van de hand te doen op 1,6 euro; gekocht aan 1,15 , zo heb ik mijn verlies van destijds toch al terug een beetje kunnen goedmaken... vele kleintjes maken een groot zei de mug , en ze deden een plasje in de zee ...
    de kunst is van ze de verkopen net voor de bubbel terug springt , alleen is die kunst heel moeilijk onder de knie te krijgen en vaak een kwestie van geluk
  6. forum rang 4 Sentiment 27 augustus 2019 19:35
    quote:

    boze ridder schreef op 27 augustus 2019 13:44:

    ik hoop ze terug van de hand te doen op 1,6 euro; gekocht aan 1,15 , zo heb ik mijn verlies van destijds toch al terug een beetje kunnen goedmaken... vele kleintjes maken een groot zei de mug , en ze deden een plasje in de zee ...
    de kunst is van ze de verkopen net voor de bubbel terug springt , alleen is die kunst heel moeilijk onder de knie te krijgen en vaak een kwestie van geluk

    je kan inderdaad morgen al weer te laat zijn....
  7. [verwijderd] 28 augustus 2019 08:28
    bovendien heb ik al vaak gedacht net voor de cijfers uit te stappen , ik heb het nooit gedurfd (FOMO) , ook deze keer twijfel ik, maar misschien is het deze keer wel anders dan anders, er is zo een lage verwachting ondertussen dat misschien wel elke omzetstijging of elke sprakeltje hoop de boel doet stijgen ... decisions have to be made ! :)
  8. fly like an eagle 28 augustus 2019 10:47
    ja morgen de dood of de gladiolen. Er is gisteren wel weer met relatief forse aantallen gehandeld, maar lijken een boel gelukzoekers-day traders en denk niet aan insiders die de prijs omhoog zetten. Zit al lang in MDx en heb ook de stijgingen vanaf 2013-2014 meegemaakt en destijds beslist nodige verdiend. Echter het weggeven van de biomarker IP rechten aan Exact, het onverwacht niet landen van Confirm en de hoge kosten aan sales met beroerde communicatie van Jan Groen doet mij ook afvragen of dit nog goed gaat komen. Select is wel een parel maar moet snel zonder het toucheren kunnen worden uitgevoerd anders zijn andere testen langszij en voorbij gegaan. Of er dan nog een marktaandeel kan worden verworven is maar de vraag. De andere pareltjes als de blaastest, de licenties en samenwerkingen op andere markers en velden zijn ook nog onduidend. En qua communicatie is de nieuwe CEO nog zuiniger dan Jan Groen.
  9. [verwijderd] 28 augustus 2019 22:09
    Volledig akkoord met fly like an eagle.

    Denk niet dat de grote kentering er zal komen morgen. We zien hetzelfde stramien dat we al zovele keren hebben gezien voor de cijfers, maar op de dag zelf steeds een koude douche.
    Hoop voor de zittenblijvers dat ik ongelijk heb, we shall see, maar ik betrouw het voor geen haar meer …

    Wat Select betreft wordt het voorgesteld alsof ze morgen al in de VS kunnen verkopen, maar het is nog maar een DRAFT LCD , dus zal nog wel enige tijd overgaan alvorens dit alles effectief wordt.
  10. forum rang 4 vreemdvermogen 29 augustus 2019 08:21

    IRVINE, CA, and HERSTAL, BELGIUM– August 29, 2019 – MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today announced its financial results for the half year ended June 30, 2019, and an update on its corporate strategy, vision and outlook.

    Strategic Review Update

    Michael McGarrity appointed as Chief Executive Officer in February 2019.

    Key strategic areas of focus and execution:

    ConfirmMDx®– refocus and engage the sales organization in driving ConfirmMDx utilization into established customer base of urologists
    SelectMDx®– advance U.S. coverage for Medicare and commercial payors based on already validated market opportunity and clinical utility
    Drive focus on operating discipline with regards to P&L and operating expenses
    Evaluate deep product pipeline of previous R&D efforts and additional applications of licensed and proprietary biomarkers for additional value creation

    Progress to date against these focus areas includes:

    Leadership team significantly strengthened with appointments of John Bellano as Chief Commercial Officer and Ron Kalfus as Chief Financial Officer
    Measures implemented to stabilize and return ConfirmMDx to growth through renewed focus on established customer base
    Management encouraged by adoption rate of SelectMDx liquid biopsy test, and confident in visibility to CMS coverage – evidenced by recent positive draft Local Coverage Determination (LCD) issued August 22, 2019

    Entered into an agreement with a global diagnostics company to commence a joint development program for SelectMDx on the partner’s decentralized point-of-care system with business and commercial terms to be further determined

    Continued focus on operational execution and P&L discipline

    Michael McGarrity, CEO of MDxHealth, said:“Since joining MDxHealth in February 2019, we have undertaken a comprehensive assessment of the business, with a specific focus on operating and commercial execution. I have been impressed with the significant growth potential of ConfirmMDx and SelectMDx. While we view 2019 as a year of transition associated with the impact of non-recurring volume and revenue, as well as instability in the commercial organization and execution, we are encouraged by our sequential quarterly progress. We now have a clear strategy to stabilise and return ConfirmMDx to growth and unlock the potential of SelectMDx.

    “As part of our focus on building out market opportunity for our test menu, we are excited to announce that we have entered into an agreement with a global diagnostic company to commence a joint development program for SelectMDx on the partner’s decentralized point-of-care system. This agreement is illustrative of the opportunity for the Company to build out SelectMDx as a standard of care in prostate cancer, utilizing our proprietary capabilities to advance the promise of liquid biopsy to aid in the diagnosis and rule-out of prostate cancer. We believe this opportunity preserves SelectMDx’s growth in the Urology setting, while opening significant opportunities in the point-of-care setting and the primary care market.

    “I would also like to comment on the strength of our management team, now fortified by the additions of John Bellano as Chief Commercial Officer and Ron Kalfus as Chief Financial Officer. John is a world class commercial leader with deep and broad experience in the molecular diagnostics space. John has a strong track record of building highly productive teams and bringing value to shareholders. John and I have experience working together and I am certain he will drive accountability, performance and results in our commercial operations.

    “Ron Kalfus brings extensive expertise in financial operation in both the public and private settings. Ron has extensive experience in the CLIA laboratory business model and will apply this to our best-in-class laboratory operation to drive operating and P&L leverage. I am confident that the value of these important additions to our team will be evident in the very near term.”

    Financial Highlights for the period ended 30 June 2019

    Product revenue of $10.6 million, down 36% from $16.6 million in H1 2018, impacted by instability in the commercial organization in the latter part of 2018, as well as non-recurring revenue in H1 2018 from utility studies and out-licensed products
    Sequentially, quarter-over-quarter, product revenue was up 37% from $4.5 million in Q1 2019 to $6.1 million in Q2 2019
    Gross profit (excluding royalties and patent income) was $4.7 million or 44% of product revenue for H1 2019 compared to $10.0 million or 60% of product revenue for H1 2018. The reduction in gross profit percent is primarily due to the declines in net revenues, impacted by variances in volume, accounts receivable adjustments, and payor mix
    Operating loss of $13.9 million, an improvement of $1.1 million over the same period last year
    EBITDA loss of $12.2 million, an improvement of $1.3 million over the same period last year, as a result of optimization and focus-driven reductions in operating expenditures

    Cash collections on products of $11.6 million, down 21% compared to H1 2018
    Cash and cash equivalents of $12.2 million

    Operational highlights for the first half of 2019

    ConfirmMDx

    Billable test volume down 20%, to 8,732 in H1 2019 versus 10,864 in H1 2018. Excluding utility study testing, which increased non-recurring volume last year, our normalized patient billable test volume was down 8%
    Sequentially, quarter-over-quarter billable test volume was stable at 4,379 in Q1 2019 compared to 4,353 in Q2 2019

    SelectMDx

    Global billable test volume of 12,528, up 98% compared to 6,313 in H1 2018. Sequentially, quarter-over-quarter, global billable test volume is up 5% from 6,106 in Q1 2019 to 6,422 in Q2 2019
    US billable test volume of 10,218, up 107% compared to 4,935 in H1 2018

    Summary of billable test volume by product
    Territory Products H1 2019 H1 2018 H1 YoY
    Volume Volume % Change
    U.S. ConfirmMDx 8,732 10,864 (20)%
    SelectMDx 10,218 4,935 107%
    EU SelectMDx 2,310 1,378 68%

    Outlook and Value Creation

    Management has identified several clear value drivers to realize the Company’s growth potential. Management is confident that clear strategic focus, continued disciplined operating expense management and experience-based execution in these areas of focus will drive revenue growth.

    The following areas have been identified as key drivers:

    Proven reliability of MDxHealth’s technology, with a clear validated value proposition and clinical utility, established through both peer reviewed publication and reference-based adoption
    Experienced management team in place to lead focus and execution of initiatives
    Opportunity to drive utilization of ConfirmMDx into the Company’s current customer base with a well-trained and high-performance sales culture
    Visibility to broad coverage of SelectMDx based on the well characterized adoption and demonstrated clinical utility, further evidenced by recently issued draft LCD from Medicare in the U.S.
    Opportunity to drive significant additional adoption of SelectMDx into the alternate site point-of-care and primary care settings

    Explore focused opportunities to monetize and further build value through the Company’s additional menu and biomarker capabilities with strategic partnerships or carve outs

520 Posts
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