Cyberonics second quarter net sales increase 17% to $47.5 million

Cyberonics, Inc. (Nasdaq: CYBX) today announced results for the quarter ended October 29, 2010.

Quarterly highlights

Operating results and achievements for the second quarter of fiscal 2011 compared to the second quarter of fiscal 2010 include:

  • Net sales of $47.5 million, a 17% increase;
  • Year-over-year worldwide net product sales attributable to the epilepsy indication increased by more than 15% for the twelfth consecutive quarter;
  • U.S. net sales increased by 20%;
  • U.S. epilepsy unit sales increased by 14%;
  • Income from operations of $12.8 million, an increase of 41%;
  • EBITDA of $15.4 million, an increase of 29%.

In addition to the above financial highlights, on November 19, 2010, the company submitted its newest product, the AspireHC™ (high capacity) generator, for regulatory approvals.

Reported net income for the second quarter of fiscal 2011, like that for the second quarter of fiscal 2010, was impacted by significant tax benefits.  The second quarter of fiscal 2011 included $17.9 million, or $0.63 per diluted share, related to discrete tax benefits, while  the second quarter of fiscal 2010 included $40.5 million, or $1.40 per diluted share, related to a discrete tax benefit.  Further, excluding the above tax benefits, the estimated effective tax rate for fiscal 2011 is 39.7% as compared with 1.0% for fiscal 2010.  We continue to expect that cash payments for income taxes will not exceed 3% of income before tax during fiscal years 2011, 2012 and 2013.

As discussed below under "Use of Non-GAAP Financial Measures," the company presents in this release a non-GAAP financial measure: EBITDA.  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.  

Net sales

Worldwide net sales for the second quarter of fiscal 2011 were $47.5 million compared to $40.7 million in the comparable period of fiscal 2010, an increase of 17%.  There was no material difference on a constant currency basis.

U.S. net product sales increased to $40.1 million compared with $33.5 million in the comparable period of fiscal 2010, an increase of $6.5 million or 20%.

International unit sales increased by 6% in the second quarter of fiscal 2011, and international net sales increased by 3% to $7.0 million.  On a constant currency basis, international net sales increased by approximately 6%.

For the six-month period ended October 29, 2010, worldwide net sales totaled $92.3 million, an increase of $13.0 million or 16% over the same period of fiscal 2010.

Gross profit

The gross profit for the second quarter of fiscal 2011 was 88.3% of net sales compared to 87.4% in the second quarter of fiscal 2010.  This increase is primarily a result of higher prices, a greater proportion of sales originating from U.S., increased production volumes and improved manufacturing efficiencies.

Operating expenses

Driven primarily by higher investment in product development, operating expenses increased by $2.6 million to $29.1 million for the second quarter of fiscal 2011 from the $26.5 million recorded in the comparable period of fiscal 2010 and increased by $1.5 million from the first quarter of the current fiscal year.

For the six-month period ended October 29, 2010, operating expenses totaled $56.8 million, an increase of $3.6 million, or 7% over the same period of fiscal 2010.

Product development expenses related to epilepsy increased as planned, and we expect this trend to continue throughout fiscal 2011.  Total research and development spending increased by 37%, or $1.9 million, from the second quarter of fiscal 2010 to $7.0 million, and represented 14.8% of net sales.  For the full fiscal year 2011, we expect total research and development expense of approximately 15% of net sales.

Expenses for the quarter ended October 29, 2010 included $1.7 million for stock-based compensation, a reduction of $0.5 million from the comparable period of fiscal 2010.  We estimate that stock-based compensation expense for fiscal 2011 will be approximately $6.5 million.

Income from operations

The company reported income from operations of $12.8 million during the second quarter of fiscal 2011, representing 26.9% of net sales, compared with operating income of $9.1 million, or 22.3% of net sales, in the comparable period of fiscal 2010.

For the six-month period ended October 29, 2010, income from operations totaled $24.5 million, compared to $15.6 million in the same period of fiscal 2010.

Income taxes

The company recorded non-cash discrete tax benefits in the second quarter of fiscal 2011 of $17.9 million resulting from the reversal of a portion of its remaining deferred tax asset valuation allowance as well as a one-time tax benefit arising from a repatriation of losses realized by our European subsidiary.  The second quarter of fiscal 2010 included a discrete tax benefit of $40.5 million resulting from the reversal of a portion of its valuation allowance for deferred tax assets.  For the balance of fiscal 2011, the company's effective tax rate is likely to be approximately 40%, depending on future stock option exercises.  This effective tax rate may be mitigated by the impact of the research and development tax credit, if and when those provisions are extended by Congress.  As noted above, we continue to expect that cash payments for income taxes will not exceed 3% of income before tax during fiscal years 2011, 2012 and 2013.

Net income

The company reported GAAP net income of $24.9 million, or $0.88 per diluted share, for the second quarter of fiscal 2011, compared with GAAP net income of $50.1 million, or $1.73 cents per diluted share, in the second quarter of fiscal 2010.  As discussed previously, both quarters were materially impacted by significant discrete tax benefits.

Balance sheet and cash flow

The company reported operating cash flow of $16.4 million for the quarter ended October 29, 2010.  Available cash balances were $67.9 million at quarter end and debt outstanding was $7.0 million.  

Stock repurchase update

Through October 29, 2010, the company has repurchased approximately 287,000 shares of Cyberonics, Inc. common stock pursuant to the program announced earlier this calendar year whereby the Board of Directors authorized a repurchase of up to 1.0 million shares.

Results and objectives

"Fiscal 2011 results remain strong, with a sales increase of 17% and operating income increasing by 41% to $12.8 million," commented Dan Moore, Cyberonics' President and Chief Executive Officer.  "The U.S. epilepsy team again exceeded expectations and recorded a strong quarter, with U.S. epilepsy unit sales increasing by 14%.  This performance continues the excellent progress we have seen over the last twelve months in the U.S. market.

"International unit sales this quarter showed 6% growth on the prior year.  We have increased our efforts to address ongoing weakness in several key markets, including the U.K. and Germany.  Development of the Japanese market is an important focus, and we remain confident of the market potential.  The regulatory approval requirements that implanting surgeons be approved in advance and that our distributor, Nihon Kohden, maintain a registry for all patients have resulted in slower than anticipated initial implant rates.  However, the patient demand is consistent with our prior assumptions.

"We continue to expand our product development capability, with R&D expenditures up 37% in the most recent quarter over 2010.  In addition, we are pleased to report that our team met an important milestone when we submitted applications for approval of the AspireHC generator to the FDA and to our EU notified body on November 19, 2010."

Fiscal 2011 guidance

Based on the results of the first six months of the fiscal year, Cyberonics is increasing its net sales guidance to the range of $187 million to $190 million on a constant currency basis, as compared to the previously provided range of $184 million to $188 million.  In addition, the company now expects that income from operations will be in the range of $45 million to $48 million, as compared to the previously provided range of $42 million to $45 million.

SOURCE Cyberonics, Inc.

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