ResMed Unveils Lumis Series of Noninvasive Ventilation Devices
May 20 15
ResMed Inc. has unveiled the Lumis series of noninvasive ventilation devices with wireless connected care capabilities. The Lumis series builds upon ResMed's legacy of innovation as a new option for patients with respiratory challenges who are not dependent on continuous ventilation. The Lumis series comprises the Lumis 100 VPAP S, Lumis 100 VPAP ST and Lumis 150 VPAP ST noninvasive ventilators that support a variety of therapy modes, built-in wireless connectivity, integrated humidification and intuitive simplicity that are the hallmarks of the series. Lumis is the first ResMed ventilation platform with IntelligentAir, a collection of ResMed technologies that can tailor therapy to individual breathing needs, making truly personalized ventilation possible. The complete IntelligentAir suite for Lumis includes iVAPS (ResMed's unique volume-assurance therapy mode), iBR (an intelligent Backup Rate), and AutoEPAP (which maintains upper airway patency), as well as other features to personalize and fine-tune individual patient's synchrony and comfort (Vsync, TiControl, and trigger and cycle settings). Lumis's each device features built-in HumidAir heated humidification capabilities and the popular Climate Control Auto setting, which automatically determines optimal humidification by adjusting to ambient room conditions. Lumis is compatible with ClimateLineAir Oxy tubing that allows for added oxygen to be heated and humidified, which is useful for patients with chronic obstructive pulmonary disease. In addition, the Lumis optional Ramp and Ramp Down features can ease the transition onto ventilation and back to spontaneous breathing when therapy is complete. The Lumis series was designed with connected care capabilities that can improve overall patient care and streamline patient monitoring and therapy management. Lumis' built-in wireless connectivity means that clinicians and home medical equipment providers have next-day access to a wide range of their patients' therapy parameters, including blood oxygen saturation when an oximeter is attached. These data, along with therapy statistics and trend data useful for home titration and monitoring, are automatically and securely transmitted to AirView, ResMed's cloud-based patient management system. AirView also includes a popular Remote Assist feature that providers can use to troubleshoot common therapy questions and change therapy settings remotely. Lumis devices are designed for simplicity and ease-of-use right out of the box. Every device comes built for quick setup thanks to an easy-to-read color screen, improved menu format, and simple push-dial navigation. Lumis' QuickNav feature also allows for easy toggling between the settings and monitoring screens to make it easy to see the real-time impact of configuration changes.
ResMed Inc. Provides Update on Phase III SERVE-HF Study of Adaptive Servo-Ventilation (Asv) Therapy
May 13 15
ResMed Inc. announced that SERVE-HF, a multinational, multicenter, randomized controlled Phase III trial did not meet its primary endpoint. SERVE-HF was designed to assess whether the treatment of moderate to severe predominant central sleep apnea with Adaptive Servo-Ventilation (ASV) therapy could reduce mortality and morbidity in patients with symptomatic chronic heart failure in addition to optimized medical care. The study did not show a statistically significant difference between patients randomized to ASV therapy and those in the control group in the primary endpoint of time to all-cause mortality or unplanned hospitalization for worsening heart failure (based on a hazard ratio [HR] = 1.136, 95% confidence interval [95% CI] = (0.974, 1.325), p-value = 0.104). A preliminary analysis of the data identified a statistically significant 2.5% absolute increased risk of cardiovascular mortality for those patients in the trial who received ASV therapy per year compared to those in the control group. In the study, the cardiovascular mortality rate in the ASV group was 10% per year compared to 7.5% per year in the control group. There were no issues associated with the performance of the ASV therapy device in the trial.
ResMed Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended March 31, 2015; Provides Gross Margin Outlook for Fourth Quarter of 2015; Provides Tax Rate Outlook for the Full Year 2015
Apr 23 15
ResMed Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended March 31, 2015. For the quarter, the company’s net revenue was $422,497,000 against $397,758,000 a year ago. Income from operations was $105,868,000 against $104,698,000 a year ago. Income before income tax was $114,358,000 against $112,912,000 a year ago. Net income was $90,983,000 against $89,969,000 a year ago. Diluted earnings per share were $0.64 against $0.63 a year ago. Non-GAAP operating income (excluding the impact of amortization of acquired intangible assets) was $108,071,000 against $107,157,000 a year ago. Non-GAAP net income (excluding the impact of amortization of acquired intangible assets) was $92,626,000 against $91,837,000 a year ago. Non-GAAP diluted earnings per share (excluding the impact of amortization of acquired intangible assets) were $0.65 against $0.64 a year ago. Cash flow from operations was $90.9 million for the quarter, reflecting strong underlying earnings and a modestly increasing working capital. Capital expenditure for the quarter was $10.6 million while depreciation and amortization for the March quarter totaled $17.9 million.
For the nine months, the company’s net revenue was $1,225,848,000 against $1,139,762,000 a year ago. Income from operations was $309,689,000 against $306,601,000 a year ago. Income before income tax was $331,800,000 against $324,443,000 a year ago. Net income was $265,424,000 against $257,535,000 a year ago. Diluted earnings per share were $1.86 against $1.78 a year ago. Net cash provided by operating activities was $283,479,000 against $275,685,000 a year ago. Purchases of property, plant and equipment was $50,266,000 against $54,210,000 a year ago. Non-GAAP operating income (excluding the impact of amortization of acquired intangible assets) was $316,247,000 against $313,926,000 a year ago. Non-GAAP net income (excluding the impact of amortization of acquired intangible assets) was $270,375,000 against $263,098,000 a year ago. Non-GAAP diluted earnings per share (excluding the impact of amortization of acquired intangible assets) were $1.90 against $1.82 a year ago. Patent registration costs were $7,109,000 against $5,691,000 a year ago.
For the fourth quarter of 2015, the company expects gross margin to be broadly consistent with third quarter being in the range of 59% to 60%, assuming current exchange rates. Gross margin drivers like currency fluctuations and geographic and product mix could swing this range further if they move beyond their expectations.
The company estimates its effective tax rate for the full fiscal year 2015 will be in the range of 20% to 21%.