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MDxHealth nieuws 2013

774 Posts, Pagina: « 1 2 3 4 5 6 7 8 ... 35 36 37 38 39 » | Laatste
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Morgen voorbeurs de cijfers DoC?
Eindelijk komt er wat leven in de brouwerij, morgen hopelijk over de 3 euro !
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paar 1000 verkoop last minute zorg voor een grote stap terug 2,63-2,54.
Kan mij niet aan de indruk onttrekken dat er een grote jongen zoveel mogelijk en zo laag mogelijk wilt, waarom; dat weten we misschien morgen wel..
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quote:

Uperdepup schreef op 21 augustus 2013 17:35:

paar 1000 verkoop last minute zorg voor een grote stap terug 2,63-2,54.
Kan mij niet aan de indruk onttrekken dat er een grote jongen zoveel mogelijk en zo laag mogelijk wilt, waarom; dat weten we misschien morgen wel..
Opmerkelijk schrale dumps zeg!
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Of iemand durf het niet aan,
of het is voorkennis en morgen (voorbeurs?) valt het zwaar tegen,
of morgen krijgen we zulk goed nieuws dat er door dit dumpje weer 10.000en aandelen onder de 2,60 aangekocht kunnen worden door een grote jongen.

Of de waarheid ligt in het midden, buiten dit alles weer een echte MDXH beweging..
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Ik ben zeer benieuwd naar de cijfers van morgen.
De vorige keer ging de koers ook een dag voor de tijd al naar beneden.
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Morgen ( straks ) wordt een topdag! Ik hoop het maar, want ik zit in het vliegtuig vanaf 0800h.. Dit wordt dus effe afwachten voor mij, ik zie het wel als ik weer online ben... tot na mijn kleine vakantie!
Superdude
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MDxHealth reported commercial and total revenues of €3.0 million in the first half of 2013, a 51% increase versus the same period in 2012. Commercial revenues grew by 108% over the first half of 2012. There were no grant or subsidy revenues during the first half of 2013. The company's cash position was significantly improved through an €18 million private placement which closed on June 25, 2013.

On June 7th MDxHealth partner Exact Sciences (NASDAQ: EXAS) submitted the final module of the premarket approval (PMA) application for Cologuard(TM), the company's molecular stool-based colorectal cancer screening test to the U.S. Food and Drug Administration. Pending FDA approval Exact Sciences is now preparing for the commercial launch of their test. MDxHealth expects to receive milestone payments and royalties from the sale of the Cologuard test.

"Adoption of our ConfirmMDx for Prostate Cancer test in the U.S. continues to accelerate. Year to date we have tested more than 42,000 prostate biopsies from over 3,500 patients. This represents a sequential increase of 82% in volume in Q2 over Q1 2013," said Dr. Jan Groen, CEO of MDxHealth. "We continue to build our commercialization structure in the U.S. to support this growth through the remainder of 2013 and beyond. Together with our partners, we now have more than 70 sales representatives in the U.S. promoting our ConfirmMDx test for Prostate Cancer test, and the penetration rates are being aided further by the growing number of payers that have recognized the clinical and economic value of the test and are reimbursing its use."

Commenting on the financial results, Dr. Groen continued: "We are pleased with the significant growth in commercial revenue thus far in 2013, derived from both diagnostic test and services sales. At this point more than 90 insurance companies have recognized the clinical utility and economic value and are reimbursing the ConfirmMDx for Prostate Cancer test. Our managed care efforts are focused on increasing coverage through contracts with third-party payors and networks. Reimbursement codes at these insurers and other third-party payors allow MDxHealth to secure appropriate payment, increase the percentage of revenue recognized, and expedite collections, while providing economic benefit to payers and the entire healthcare system."
Superdude
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Revenues
Commercial revenue in H1 2013 amounted to €3.0 million compared to €1.5 million in H1 2012, representing an increase of 108%. No revenues were derived from government grants as the company continued to focus on growing its commercial revenue sources.

Test volumes for ConfirmMDx for Prostate Cancer continued to increase, with more than 4,500 tests sold to date since launch. A steady increase in reimbursement from private third-party payers was recorded during the period, with more than 90 insurers now paying for the test. This is expected to increase further through the agreements with Multiplan and Three Rivers, which plans have combined access to 67 million covered lives.

Operating Expenses
Operating expenses for 1H 2013 were €7.6 million, increasing 24% compared to €6.1 in 1H 2012. As previously noted, this increase was attributable to the build-up of the U.S. operations in support of ConfirmMDx for Prostate Cancer test commercialization, as well as R&D investment in our pipeline of new diagnostic tests.

Non-operational and one-time restructuring costs, not expected to continue in future periods, amounted to €302K for the period.

Results
As expected, 1H 2013 loss increased over the same period in 2012 due to costs associated with growing commercial infrastructure to support U.S. sales and marketing and new product R&D investment. The company's operating loss (EBIT) increased by 39.7%, and the net loss increased by 40.2% in H1 2013.

Cash Position
MDxHealth ended the first half of 2013 with cash and cash equivalents of €24.7 million compared to €6.6 million on June 30, 2012. The increase in cash was supported in part by the €18 million gross private placement closed on June 25, 2013.

Outlook
Based on the growth in the first two quarters of 2013 we anticipate continued growth in test volumes, our customer base and payer reimbursement in coming quarters.
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quote:

everheye schreef op 22 augustus 2013 08:16:

zoveel verlies weer, zo gaat het ook niet vooruit
Vond het nog weinig gezien de extreme uitbreiding in sales. Lees onderin de de ontwikkelingen maar goed door! In q1 (2014) informdx in de sales voor revenue boosts.
The central histopathology review of the company's second multicenter validation study for ConfirmMDx for Prostate Cancer has completed. The study involved five major cancer centers in the U.S. with Prof. Dr. Alan Partin from Johns Hopkins University serving as principle investigator. Testing included 3,687 archived prostate biopsy cores from 350 men in a blinded fashion. In the coming weeks the database will be unlocked and data will be analyzed and submitted for an oral presentation at a major urology conference and publication in a leading urology journal.
The development of MDxHealth's second prostate cancer product (InformMDx) is on target. This test will provide prognostic assessment to distinguish between aggressive and non-aggressive prostate cancer. In Q1 2014 the company will start validation studies for the test.
The reimbursement climate in the U.S. is still evolving. Along with our peers in the industry, MDxHealth is closely monitoring the Centers for Medicare and Medicaid Services' (CMS) changes to the Medicare Clinical Laboratory Fee Schedule. These fee schedule changes, coupled with the changing reimbursement landscape, pose challenges for all diagnostic companies. While we believe the lack of clarity is a temporary situation, we have elected to take a conservative view and will likely adjust our per test revenue projections downward to reflect the uncertainties. Once payment histories under the new codes are well established, we will reevaluate our revenue recognition policy to determine if upward revision is appropriate.
The Company's revenue recognition policy at this time is primarily based on cash collections. Because reported revenues generally exclude uncollected outstanding billable cases, the impact of current test sales on reported revenues may be delayed by one or more calendar quarters. However, as billing and reimbursement trends are established with each payer, the Company is transitioning to an accrual-based revenue recognition policy. Additionally, MDxHealth has held claims to Medicare and will pursue payment once Medicare has reviewed and approved the company's medical dossier and finalizes reimbursement for the test, expected in 2013. Once Medicare reimbursement is obtained, the company expects a one time, retrospective billing payment for cases dating back to 2012, representing a significant, one off, increase in revenue. We anticipate a continued increase in private third-party reimbursement as new payers are included. Currently, 70% of all MDxHealth ConfirmMDx cases are non-Medicare.
Total operating costs in the second half are expected to increase in a carefully controlled manner in line with ramping up of the commercialization activities associated with the ConfirmMDx for Prostate Cancer test.
Post-closing events
MDxHealth signed a partnership agreement with Bostwick Laboratories, a full-service laboratory specializing in anatomic and clinical pathology, with a focus on uropathology, providing MDxHealth with access to one of the largest urology networks in the U.S.
In addition and as noted above, agreements were signed with MultiPlan and Three Rivers Provider Network (TRPN) to provide expanded access for the ConfirmMDx for Prostate Cancer test. These preferred provider organizations (PPO's) contract with healthcare providers typically on a discounted fee-for service basis in circumstances where the financial risk for changes in utilization of medical services appears limited based on actuarial assumptions. PPOs and third party administrators (TPA's) contract with health maintenance organizations (HMO's), self funded employers, and other payers to provide expanded choice, and services for patients, at discounted rates, with seamless claims processing and claims optimization efficiencies.
Superdude
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Nieuws

MDxHealth
2,50 ( 21/08 )

MDxHealth diept verlies uit
22-08-2013 08:22:17
Het Luikse diagnosticabedrijf MDxHealth heeft in het eerste halfjaar zijn nettoverlies verder zien oplopen. De verdubbeling van de omzet werd teniet gedaan door kosten verbonden aan de uitrol van een nieuwe prostaatkankertest in de VS.

De omzet verdubbelde tot 3,03 miljoen euro. De bedrijfskasstroom ging 5,8 miljoen euro in het rood, wat neerkomt op een verdere toename van dat verliescijfer met 42 procent. Het nettoverlies dikte 40 procent aan tot 5,97 miljoen euro.

Die verliescijfers zijn grotendeels toe te schrijven aan de uitrol van ConfirmMDx, een prostaatkankertest, in de VS. Daarvoor moet geïnvesteerd worden in een commerciële infrastructuur, die veel geld opslorpt.

Intussen wacht ook een andere test van het bedrijf, gericht op darmkanker, op toestemming van de Amerikaanse geneesmiddelenautoriteit FDA. In afwachting wordt ook daarvoor al werk gemaakt van de commerciële ondersteuning.

Intussen moet er bovendien verder geïnvesteerd worden in de productpijplijn voor nieuwe diagnostische tests. Het bedrijf heeft momenteel echter voldoende cash om dat allemaal te dragen.

In juni rondde MDxHealth een private plaatsing af, die 18 miljoen euro in het laatje bracht. Op het einde van het eerste halfjaar beschikte het bedrijf over een cashreserve van 24,7 miljoen euro. Een jaar eerder was dat nog maar 6,6 miljoen euro meer.
Diegy
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Cijfers zijn niet best. Nu snap ik waarom er gister nog een grote dump kwam in de veiling.
Superdude
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er zullen nog wel emissies volgen, aandeel zal komende jaren niet vlug stijgen volgens mij
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Aan wat voor opbrengsten moeten wij denken na deze inversteringen en te verwachten goedkeuringen ?? 10,20,30,100 meur in h2 ?
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Waarom zijn de cijfers niet best? Wat valt je tegen? kaspositie is 24mln goed om 3 jaar vol mee te burnen. Had je winst verwacht in een lanceringsfase van een product? Zijn juist bezig met forse uitbreidingen.
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