Fresenius Medical Care AG & Co. KGAANYSE
Thu, Dec. 1, 9:58 AM
- With the aim of streamlining its financial reporting, Fresenius Medical Care AG & Co. KGaA (FMS -0.9%) will only report in accordance with International Financial Reporting Standards (IFRS) beginning with its 2017 fiscal year commencing January 1.
- GAAP-based information, which was provided under its Pooling Agreement, will no longer be provided under a recently approved amendment which allows "either/or" reporting to the SEC.
Mon, Oct. 31, 9:16 AM
- Fresenius Medical Care AG & Co. KGaA (NYSE:FMS) acquires Heilbronn, Germany-based XENIOS AG from venture capital outfit zfhn Zukunftsfonds Heibronn for an undisclosed sum.
- XENIOS markets a line of medical systems used to support patients with lung and heart failure, including novalung, a platform designed to replace/reduce invasive mechanical ventilation in patients with acute respiratory failure and i-core, a synchronized cardiac assist device.
Thu, Oct. 27, 7:23 AM
Wed, Oct. 26, 5:30 PM
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Fri, Aug. 19, 10:05 AM
- Dialysis services firms are mired in selling pressure in early trading in response to the news that The Centers for Medicare & Medicaid Services (CMS) has issued a public request for information regarding the alleged steering of Medicare/Medicaid beneficiaries into other plans in order to earn higher reimbursement rates. The agency has also sent letters to all Medicare-enrolled dialysis centers informing them of its announcement.
- The request for information and letters is aimed at situations where Medicare/Medicaid patients may be steered into Affordable Care Act-compliant plans which could result in the disruption of care associated with a change in network providers. CMS wants to maintain the integrity of its programs for patients while making sure they are enrolled in appropriate plans while avoiding inappropriate costs.
- In addition to its information request, CMS is mulling its regulatory and operational options to prohibit or limit premium payments and routine waiver of cost-sharing for qualified health plans by healthcare providers, revisions to Medicare and Medicaid provider enrollment rules, the imposition of civil monetary penalties for individuals who fail to provide correct information about consumers enrolled in a plan and potential changes allowing insurers to limit their payment to healthcare providers to Medicare-based amounts for certain services and items of care.
- Dialysis services-related tickers: (DVA -5.5%)(FMS -6.2%)(ARA -15.2%)
Tue, Aug. 2, 6:43 AM
Mon, May 9, 9:10 AM
- Fresenius Medical Care's (NYSE:FMS) Vifor Fresenius Medical Care Renal Pharma (VFMCRP) enters into an agreement with OPKO Health (NYSE:OPK) to develop and commercialize RAYALDEE (calcifediol) in Europe, Canada, Mexico, Australia, South Korea and certain other international markets for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease and vitamin D insufficiency. OPKO retains the rights in the U.S., Latin America (excluding Mexico), Russia, China, Taiwan and Japan. The companies will collaborate to prepare the Marketing Authorization Application (MAA) in Europe.
- Under the terms of the agreement, OPKO will receive an upfront payment of $50M, up to $52M in regulatory and launch milestones, up to $180M in sales-based milestones and double-digit royalties. VFMCRP has the option to acquire the U.S. rights for dialysis patients. If it exercises the option, it will pay OPKO commercial-based milestones and double-digit royalties.
- In the U.S., the FDA's action date for its review of OPKO's resubmitted NDA for RAYALDEE is October 22.
- OPK is up 4% premarket on increased volume.
- Previously: FDA accepts OPKO's resubmitted NDA for RAYALDEE (April 27)
Tue, May 3, 7:45 AM
- Fresenius Medical Care (NYSE:FMS): Q1 EPS of $0.75 in-line.
- Revenue of $4.21B (+6.3% Y/Y) misses by $40M.
Mon, May 2, 5:30 PM
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Wed, Feb. 24, 7:50 AM
- Fresenius Medical Care (NYSE:FMS): Q4 Net Income of $347M.
- Revenue of $4.35B (+0.7% Y/Y) misses by $60M.
Tue, Feb. 23, 5:30 PM
Thu, Feb. 18, 7:29 AM
- Fresenius Medical Care AG & Co. KGaA (NYSE:FMS) agrees to pay $250M to resolve U.S. litigation related to its GranuFlo and NaturaLyte products. Under the terms of the agreement, 97% of the plaintiffs must agree to the settlement by July to receive funding in August. Insurers will pay $220M (88%) of the total settlement amount.
- The company intends to record a $60M charge to finalize the matter. The item will be reflected in its 2015 results that will be released on February 24.
- GranuFlo and NaturaLyte are dialysates (fluids used in dialysis that clean the blood). The FDA recalled them in March 2012 in order to revise prescribing instructions. According to the recall, the use of the products could lead to low blood pressure and cardiac arrhythmia, possibly leading up to cardiopulmonary arrest and death. The lawsuits (1,800+) began after it was discovered that Fresenius was aware of the risks and failed to inform healthcare providers and patients. A November 2011 internal company memo revealed that 900 patients experienced heart attacks in company clinics the previous year. Fresenius medical personnel concluded that patients with excessive levels of bicarbonate in their blood were six times more likely to experience cardiac arrest that those with normal levels. The memo linked GranuFlo use to increased bicarbonate levels and heart attacks.
- GranuFlo is a powdered compound that creates bicarbonate. NaturaLyte works in a similar fashion but is in liquid form. Both remain on the market in their original formulations.
Oct. 29, 2015, 9:13 AM
- Fresenius Medical Care (NYSE:FMS): Q3 EPS of $0.43 misses by $0.03.
- Revenue of $4.23B (+2.9% Y/Y) misses by $70M.
Oct. 28, 2015, 5:30 PM
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Jul. 30, 2015, 9:12 AM
- Gainers: UNXL +33%. UNIS +22%. MEET +18%. GEVO +17%. SHOP +15%. OTEX +15%. WWE +15%. SGYP +13%. SKX +12%. MWW +9%. HBP +8%. HOLX +8%. WDC +8%. APD +6%.
- Losers: PRSN -35%. LNCO -21%. LINE -19%. FMI -18%. SSYS -18%. ITG -14%. FOE -13%. WFM -12%. QRVO -12%. OSK -11%. LOCK -11%. DDD -9%. MNKD -7%. NCR -6%. GNCA -6%. FMS -5%. MPC -5%. CROX -5%.
Jul. 30, 2015, 6:30 AM
- Fresenius Medical Care (NYSE:FMS): Q2 EPS of $0.79 beats by $0.36.
- Revenue of $4.2B (+9.4% Y/Y) beats by $70M.