HOUSTON, Nov. 20, 2014 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX) today announced results for the quarter ended October 24, 2014.
Quarterly highlights[1]
Operating results for the second quarter of fiscal 2015 compared to the second quarter of fiscal 2014, and other achievements, include:
- Worldwide net sales of $73.4 million, an increase of 5%;
- Continued growth in international net sales to $13.5 million, and increased by 13% on a constant currency basis;
- U.S. net sales reached a new high of $59.9 million;
- Record income from operations of $26.3 million, an increase of 20%;
- Net income of $17.3 million, or $0.64 cents per diluted share.
- Adjusted non-GAAP income per diluted share of $0.63 compared with income per diluted share of $0.50, an increase of 26%;
- Continued adoption of AspireSR® generator in Europe;
- CE Mark approval for the ProGuardianRest system;
- Regulatory submission of the AspireSR generator to the U.S. Food and Drug Administration (“FDA”);
- Submission of the remaining modules for CE Mark approval of the Vitaria generator, which provides Autonomic Regulation Therapy (“ART”) for chronic heart failure.
1 | The financial and operating results for the thirteen and twenty-six weeks ended October 24, 2014 and October 25, 2013 include and exclude certain items for the purposes of non-GAAP comparisons. As discussed below under “Use of Non-GAAP Financial Measures” in this release, the company refers to and makes comparisons with certain non-GAAP financial measures. Investors should consider non-GAAP measures in addition to, and not as a substitute for or superior to, financial performance measures prepared in accordance with GAAP. Please refer to the attached non-GAAP reconciliation. Numbers may be affected by rounding. |
Results and objectives
“Cyberonics delivered increased sales during our second quarter of fiscal 2015,” commented Dan Moore, President and Chief Executive Officer. “We achieved record operating income, and on an adjusted non-GAAP basis, record net income and earnings per share. Our U.S. business continues to show sequential growth, and increased net sales by 4% over the comparable quarter in the prior year, reaching a new high of $59.9 million; however, U.S. net sales fell short of our expectations. We estimate that more patients were implanted with a VNS Therapy® System in the U.S. during the recently completed quarter than in any quarter in the company’s history, although new patient implants did not surpass the recent high seen in the second quarter of last fiscal year.
“International sales again showed consistent growth, with unit sales increasing by 11% and net sales increasing to $13.5 million, and by 13% on a constant currency basis. All regions showed solid volume growth for the quarter. The introduction of our AspireSR generator is progressing well. Sales of the AspireSR generator accounted for 12% of all international sales, and more than 30% of unit sales in those countries where it is now available.
“We formally submitted our AspireSR generator for U.S. regulatory approval while continuing a dialogue with FDA. The AspireSR generator is the first closed-loop VNS Therapy System and is an important addition to our product portfolio, as demonstrated in the European launch.
“We continue to make progress on the ProGuardian platform, with the regulatory approval of ProGuardianREST system in Europe. We anticipate a limited market launch in the U.K. later in the current fiscal year.
“Following the presentation of the encouraging results of the ANTHEM-HF clinical study of ART for chronic heart failure patients with reduced ejection fraction at the European Society of Cardiology meeting in September, we completed the regulatory submission to obtain a CE Mark.
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