Cyberonics (NASDAQ: CYBX) reported Q4 EPS of $0.64, $0.01 better than the analyst estimate of $0.63. Revenue for the quarter came in at $74.1 million versus the consensus estimate of $77.44 million.

Results and objectives

"For the seventh consecutive year, the Cyberonics team delivered record net sales and operating income," commented Dan Moore, Cyberonics' President and Chief Executive Officer. "We are pleased to report continuation of our consistent multi-year sales and profit growth. We achieved our two most important regulatory approvals with the recent announcement of our U.S. approval for the AspireSR generator, along with the CE Mark approval of the VITARIA™ generator announced earlier this year. These two products provide a solid foundation for continued growth for the company.

"With the additional opportunities arising from the pending merger with Sorin, expected to close by the end of September 2015, we plan to increase our efforts to bring these important products to patients with epilepsy and CHF. In advance of the expected closing of our proposed merger, we made several changes to senior management at the start of the 2016 fiscal year.

Jason Richey, Vice President and General Manager International, has assumed responsibility for all U.S. commercial activity, including sales, marketing and reimbursement.
Mark Verratti, Vice President for Worldwide Sales, will assume the International role from Jason, and in addition, be responsible for planning the international commercial integration, as well as international CHF commercialization.
Sherrie Perkins, Vice President, New Business Development, has assumed the Project Manager role on the integration team.

"Both Jason and Mark will report directly to Rohan Hoare, Chief Operating Officer. Jason's experience with the launch of the AspireSR generator in Europe and EMMEA brings significant benefit to the U.S. sales team as we launch this new, technologically-advanced product in our largest market.

"Further, we are pleased to announce the addition of John Murphy, Ph.D., as Vice President, Research & Development. John has more than 19 years of relevant product design and engineering experience at large medical device companies and in a range of industries, including telecommunications and defense-related companies. In his most recent company, John's positions included Vice President, R&D, Neuromodulation; Vice President, Hardware Engineering Implantable Electrical Systems Division (IESD); and Vice President, Electrical Engineering & Power Component for IESD.

"International growth continued its strong trajectory, with adjusted revenue growth for fiscal 2015 of approximately 17% on a constant currency basis, and all regions achieving very robust sales growth. The AspireSR generator provided a significant contribution, with penetration increasing substantially as the year progressed. The AspireSR generator accounted for 17% of all international unit sales in the third quarter and grew to 23% in the fourth quarter. We are especially pleased that in U.K. and Germany, where the product was initially launched, the AspireSR generator accounted for over 50% of unit sales in the fourth quarter, and many accounts have converted all their purchases to the new generator.

"Our U.S. sales were disappointing for the year, with new-patient activity weaker than planned. We expect significant improvement in fiscal 2016 following a refocused approach under Jason Richey's leadership and are also excited that AspireSR will now be available for our sales force.

"We have also made progress with the ProGuardian™ product, and recently shipped the first systems to the U.K. to commence a limited market evaluation, now underway. Following an internal review of the Centro™ generator, we concluded that additional design improvements were warranted. As a result of the decision to redesign the product, we wrote-down some of the assets associated with the original Centro program. As evidenced in cardiac rhythm management, we continue to believe that the functionality of a wireless-enabled generator will be important addition to our future product offering.

"With the previously announced CE Mark approval to market the VITARIA System in Europe to treat patients suffering from chronic heart failure, we initiated a limited commercial launch and achieved our first commercial implant. We formed a dedicated sales team to market this new product in Europe. Our second study, ANTHEM-HFpEF, focused on heart failure patients with preserved ejection fraction, is also progressing," concluded Mr. Moore.

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