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ASPM > SEC Filings for ASPM > Form 10-Q on 6-Nov-2009All Recent SEC Filings

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Form 10-Q for ASPECT MEDICAL SYSTEMS INC


6-Nov-2009

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.

Agreement and Plan of Merger
On September 27, 2009, we entered into an Agreement and Plan of Merger, or Merger Agreement, with United States Surgical Corporation, a Delaware corporation, which we refer to herein as Parent, and Transformer Delaware Corp., a Delaware corporation and a wholly-owned subsidiary of Parent, which we refer to herein as Purchaser. Parent and Purchaser are wholly-owned subsidiaries of Covidien plc. Pursuant to the Merger Agreement, Purchaser has completed a cash tender offer for all of our outstanding common stock at a purchase price of $12.00 per share. The tender offer expired at 12:00 midnight at the end of November 5, 2009, after which Purchaser accepted and paid for all shares validly tendered and not withdrawn at the time, representing approximately 90% of our outstanding common stock (not including 297,066 shares of common stock tendered under guaranteed delivery procedures). Pursuant to the terms of the Merger Agreement, Purchaser exercised its option to purchase newly issued shares from us at the tender offer price. Following the purchase, Purchaser owned sufficient shares to effect a short-form merger with and into Aspect, which will then become an indirect wholly owned subsidiary of Covidien (the "Merger"). We expect that Purchaser will complete the Merger as soon as practicable . For a further discussion of the Offer and the Merger, refer to footnote 14 of the notes to our condensed consolidated financial statements included in this quarterly report on Form 10-Q.
Overview
We develop, manufacture and market an anesthesia monitoring system that we call the BISŪsystem. The BIS system is based on our patented core technology, the Bispectral Index, which we refer to as the BIS index. The BIS system provides information that allows clinicians to assess and manage a patient's level of consciousness in the operating room, intensive care and procedural sedation settings and is intended to assist the clinician in better determining the amount of anesthesia or sedation needed by each patient. Our proprietary BIS system includes: our BIS monitor; BIS Module Kit, which includes components of BIS monitoring technology that are integrated into equipment sold by original equipment manufacturers, or BISx system, which allows original equipment manufacturers to incorporate the BIS index into their monitoring products; and our group of sensor products, which we collectively refer to as BIS Sensors. On July 28, 2009, we entered into a distribution and technology licensing agreement with LiDCO Limited, which we refer to as the LiDCO Distribution Agreement. Under the terms of the agreement, we obtained exclusive rights to market, sell and distribute the LiDCOrapid monitoring system as well as non-exclusive rights to market, sell and distribute the LiDCOplus system in the United States. In addition, the agreement includes an exclusive license to integrate LiDCO and BISŪ technologies into a combined product for sale in the United States.
We derive our revenue primarily from sales of BIS Sensors and from our original equipment manufacturer products (including BIS Module Kits and the BISx system) and related accessories, and BIS monitors, which we collectively refer to as Equipment. In addition, our domestic revenue also includes sales of LiDCO Smart Cards as part of the LiDCO Distribution Agreement. We refer to revenue from sales of the LiDCOrapid monitoring systems and related products as "LiDCO revenue". To assist management in assessing and managing our business, we segregate our revenue by sales by region and sales by products, as shown in the following table:

                                                      Three Months Ended                         Nine Months Ended
                                              October 3,          September 27,          October 3,          September 27,
                                                 2009                 2008                  2009                 2008
                                                                         (dollars in thousands)
Domestic revenue                              $    18,418        $        17,337        $     52,506        $        51,747
Percent of total revenue                               70 %                   70 %                69 %                   70 %

International revenue                         $     7,817        $         7,421        $     23,922        $        22,624
Percent of total revenue                               30 %                   30 %                31 %                   30 %

Total revenue                                 $    26,235        $        24,758        $     76,428        $        74,371

BIS Sensor revenue                            $    21,814        $        20,788        $     64,927        $        62,819
Percent of total revenue                               83 %                   84 %                85 %                   84 %

Equipment revenue                             $     4,345        $         3,970        $     11,425        $        11,552
Percent of total revenue                               17 %                   16 %                15 %                   16 %

LiDCO revenue                                 $        76                      -        $         76                      -
Percent of total revenue                                -                      -                   -                      -

Total revenue                                 $    26,235        $        24,758        $     76,428        $        74,371


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At October 3, 2009, we had cash, cash equivalents, restricted cash and investments of approximately $82.7 million and working capital of approximately $93.4 million.
We follow a system of fiscal quarters as opposed to calendar quarters. Under this system, the first three quarters of each fiscal year end on the Saturday of the thirteenth week of each quarter and the last quarter of the fiscal year always ends on December 31.
We believe our ability to grow our revenue is directly related to whether our customers continue to purchase and use our BIS Sensors after they purchase our Equipment. As we seek to continue to achieve this growth, we have expanded our sales forces and have implemented new sales and marketing programs. We expect that as we seek to grow our business, revenue from the sale of BIS Sensors will contribute an increasing percentage of product revenue. Additionally, we believe that, over time, revenue from the sale of BIS Module Kits and our BISx system will increase as a percentage of total Equipment revenue as healthcare organizations purchase our technology as part of an integrated solution offered by our original equipment manufacturers. We also expect revenue from our LiDCO Distribution Agreement to contribute to product revenue as we continue to incorporate LiDCO's advanced hemodynamic monitoring system into our product portfolio.
In order to sustain profitability, we believe that we need to continue to maintain our gross profit and control the growth of our operating expenses. To maintain our gross profit, we believe we must continue to focus on maintaining our average unit sales prices of our BIS Sensors, increasing revenue from the sale of BIS Sensors as a percentage of total revenue, as BIS Sensors have a higher gross profit than Equipment, and continuing to reduce the costs of manufacturing our products.
For those healthcare organizations desiring to acquire our BIS monitors directly from us, we offer two primary options. Our customers have the option either to purchase BIS monitors outright or to acquire BIS monitors pursuant to a sales-type lease agreement whereby the customer contractually commits to purchase a minimum number of BIS Sensors per BIS monitor per year. Under our sales-type leases, customers purchase BIS Sensors and the BIS monitor for the purchase price of the BIS Sensors plus an additional charge per BIS Sensor to pay for the purchase price of the BIS monitor and related financing costs over the term of the agreement. We also grant these customers an option to purchase the BIS monitors at the end of the term of the agreement, which is typically three to five years. We recognize Equipment revenue under sales-type lease agreements either at shipment or delivery in accordance with the agreed upon contract terms with interest income recognized over the life of the sales-type lease. The cost of the BIS monitor acquired by the customer is recorded as costs of revenue in the same period.
We also offer customers the opportunity to use the BIS monitors under our Equipment Placement program, which we refer to as the EP program. Under the EP program, the customer is granted the right to use the BIS monitors for a mutually agreed upon period of time. During this period, the customer purchases BIS Sensors at a price that may include a premium above the list price of the BIS Sensors to cover the rental of the equipment, but without any binding minimum purchase commitments. At the end of the agreed upon period, the customer has the option of purchasing the BIS monitors, continuing to use them under the EP program or returning them to us.
We have subsidiaries in The Netherlands, United Kingdom, Germany and France to facilitate the sale of our products into the international market. We are continuing to develop our international sales and distribution program through a combination of distributors and marketing partners, including companies with which we have entered into original equipment manufacturer relationships.
We are party to a distribution agreement with Nihon Kohden Corporation to distribute BIS monitors in Japan. Nihon Kohden has received approval from the Japanese Ministry of Health, Labor and Welfare for marketing in Japan our A-1050 EEG Monitor with BIS, our A-2000 BIS Monitor, our BIS module (our product that integrates BIS monitoring technology into equipment sold by original equipment manufacturers), our BIS XP system and, most recently in December 2007, our BISx and the BIS VISTA monitor. In January 2002, the Japanese Ministry of Health, Labor and Welfare granted reimbursement approval for use of our BIS monitors. With this approval, healthcare providers in Japan are eligible to receive partial reimbursement of 1,000 Yen each time BIS monitoring is used. Sales to Nihon Kohden represented approximately 16% and 15% of international revenue in the three and nine months ended October 3, 2009, respectively, and approximately 15% of international revenue in both the three and nine months ended September 27, 2008.


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We account for share-based payments to employees under the Stock Compensation subtopic of the Accounting Standards Codification of the Financial Accounting Standards Board, or FASB. For the three and nine months ended October 3, 2009, we recognized approximately $1.3 million and $4.3 million, respectively, of stock-based compensation expense in our condensed consolidated statements of income and in the three and nine months ended September 27, 2008, we recognized approximately $1.9 million and $5.8 million, respectively, of stock-based compensation expense. See Note 2 of the Notes to our Condensed Consolidated Financial Statements contained in Item 1 of this Quarterly Report on Form 10-Q for further information regarding stock-based compensation.
Various factors may adversely affect our quarterly operating results at least through the fourth quarter of 2009. For example, a third party study that was published in March 2008 in the New England Journal of Medicine compared BIS monitoring with a protocol based on end-tidal gas anesthetic in a patient population considered to be at high risk of awareness and concluded that, based upon a similar occurrence of awareness in both groups, no benefit of BIS monitoring was demonstrated. While the study results were consistent with earlier studies that showed a low incidence of awareness using BIS, we believe the conclusions drawn by the authors are not supported by their data and that there were several flaws in the design and execution of the trial. However, we believe that the publication of this study has had, and may continue to have an adverse effect on the rate at which existing or potential new customers purchase and use our products. We have also expanded our sales force and expect that the resulting increase in operating expenses would not be offset, at least initially, by an increase in revenue. Additionally, we face risks beyond our control presented by the continued challenges of the U.S. and worldwide economies, the healthcare industry, hospital purchases and our business. On September 27, 2009, we entered into the Merger Agreement, and sales of our products may be adversely affected as a result of our agreement to be acquired by an affiliate of Covidien pursuant to the terms of the Merger Agreement. Critical Accounting Policies and Estimates Management's discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. Note 2 of the Notes to Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q includes a summary of our significant accounting policies and methods used in the preparation of our financial statements. In preparing these financial statements, we have made estimates and judgments in determining certain amounts included in the financial statements. The application of these accounting policies involves the exercise of judgment and use of assumptions as to future uncertainties and, as a result, actual results could differ from these estimates. We do not believe there is a significant likelihood that materially different amounts would be reported under different conditions or using different assumptions. We believe that our critical accounting policies and estimates are as follows:
Revenue Recognition
We sell our BIS monitors primarily through a combination of a direct sales force and distributors. We sell our BIS modules to original equipment manufacturers who incorporate them into their equipment and sell to the end user. BIS Sensors are sold through a combination of a direct sales force, distributors and original equipment manufacturers. Direct product sales are structured as sales, sales-type lease arrangements or sales under our EP program. Revenue is recognized when persuasive evidence of an arrangement exists, product delivery has occurred or services have been rendered, the price is fixed or determinable and collectibility is reasonably assured. For product sales, revenue is not recognized until title and risk of loss have transferred to the customer.
Under our sales-type leases, customers purchase BIS Sensors and the BIS monitor for the purchase price of the BIS Sensors plus an additional charge per BIS Sensor to pay for the purchase price of the BIS monitor and related financing costs over the term of the agreement. The minimum lease payment, consisting of the additional charge per BIS Sensor, less the unearned interest income, which is computed at the interest rate implicit in the lease, is recorded as the net investment in sales-type leases. We recognize Equipment revenue under sales-type lease agreements either at shipment or delivery in accordance with the agreed upon contract terms with interest income recognized over the life of the sales-type lease. The cost of the BIS monitor acquired by the customer is recorded as costs of revenue in the same period it is acquired. We review and assess the net realizability of our investment in sales-type leases at each reporting period. This review includes determining, on a customer specific basis, if a customer is significantly underperforming relative to the customer's cumulative level of committed BIS Sensor purchases as required by the sales-type lease agreement. If a customer is underperforming, we record an allowance for lease payments as a charge to revenue to reflect the lower estimate of the net realizable investment in sales-type lease balance. Changes in the extent of underperformance in the agreements could increase or decrease the amount of revenue recorded in future periods.


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We recognize revenue either at shipment or delivery in accordance with the agreed upon contract terms with distributors and original equipment manufacturers. Contracts executed for sales to distributors and original equipment manufacturers include a clause that indicates that customer acceptance is limited to confirmation that our products function in accordance with our applicable product specifications in effect at the time of delivery. Formal acceptance by the distributor or original equipment manufacturer is not necessary to recognize revenue provided that we objectively demonstrate that the criteria specified in the acceptance provisions are satisfied. Each product is tested prior to shipment to ensure that it meets the applicable product specifications in effect at the time of delivery. Additionally, we have historically had a minimal number of defective products shipped to distributors and original equipment manufacturers, and any defective products are subject to repair or replacement under warranty as distributors and original equipment manufacturers do not have a right of return.
We exercise judgment in determining the specific time periods in which we can recognize revenue in connection with sales of our products. To the extent that actual facts and circumstances differ from our initial judgments, our revenue recognition could change accordingly and any such change could affect our reported results.
Stock-Based Compensation
The Stock Compensation Topic of the FASB Accounting Standards Codification requires that stock-based compensation expense associated with equity instruments be recognized in the consolidated statement of income. Determining the amount of stock-based compensation to be recorded requires us to develop estimates to be used in calculating the grant-date fair value of stock options. We calculate the grant-date fair values using the Black-Scholes valuation methodology. The use of valuation models requires us to make estimates of the following assumptions:
Risk-free interest rate: the implied yield currently available on U.S. Treasury zero-coupon issues with a remaining term equal to the expected term used as the assumption in the model.
Expected term: the expected term of an employee option is the period of time for which the option is expected to be outstanding. We use a Monte Carlo simulation model to estimate the assumed expected term for the grant date valuation as we believe that this information is currently the best estimate of the expected term of a new option.
Expected volatility: in estimating expected volatility, we consider both trends in historical volatility and the implied volatility of our publicly traded stock. We used a combination of our implied volatility and historical volatility to estimate expected volatility for the three and nine months ended October 3, 2009. We believe that in addition to the relevance of historical volatility, consideration of implied volatility is appropriate since it represents the expected volatility that marketplace participants would likely use in determining an exchange price for an option, and is therefore an appropriate assumption to use in the calculation of grant date fair value.
Additionally, we are required to make assumptions regarding the forfeiture rate, which we estimate at the time of grant and revise, if necessary, in subsequent periods if actual forfeitures differ from those estimates. We used a forfeiture rate of approximately 7.1% in our calculation at October 3, 2009. We re-evaluate this forfeiture rate on a quarterly basis and adjust the rate as necessary.
These assumptions involve significant judgment and estimates. Future stock-based compensation expense could vary significantly from the amount recorded in the current period due to changes in assumptions and due to the extent of stock option activity and restricted stock issued in future periods.
As of October 3, 2009, the total unrecognized compensation cost related to unvested stock options and unvested restricted stock awards was $4,228,000 and $3,792,000 respectively, which will be amortized over the weighted average remaining requisite service of 28 months and 21months, respectively.
Allowance for Doubtful Accounts
We determine our allowance for doubtful accounts by making estimates and judgments based on our historical collections experience, current trends, historical write-offs of our receivables, credit policy and a percentage of our accounts receivable by aging category. We also review the credit quality of our customer base as well as changes in our credit policies. We continuously monitor collections and payments from our customers. While credit losses have historically been within our expectations and the provisions established, our credit loss rates in the future may not be consistent with our historical experience. To the extent that we experience a deterioration in our historical collections experience or increased credit losses, bad debt expense would likely increase in future periods.


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Inventories
We value inventory at the lower of cost or estimated market value, and determine cost on a first-in, first-out basis. We regularly review inventory quantities on hand and record a provision for excess or obsolete inventory primarily based on production history and on our estimated forecast of product demand. The medical device industry in which we market our products is characterized by rapid product development and technological advances that could result in obsolescence of inventory. Additionally, our estimates of future product demand may prove to be inaccurate, in which case we would need to change our estimate of the provision required for excess or obsolete inventory. If revisions are deemed necessary, we would recognize the adjustments in the form of a charge to costs of revenue at the time of the determination. Therefore, although we continually update our forecasts of future product demand, any significant unanticipated declines in demand or technological developments, such as the introduction of new products by our competitors, could have a significant negative impact on the value of our inventory, results of operations and cash flows in future periods.
Warranty
Equipment that we sell is generally covered by a warranty period of twelve months for direct business and up to twenty four months for distributor or OEM business. We accrue a warranty reserve for estimated costs to provide warranty services. Our estimate of costs to service its warranty obligations is based on historical experience and an expectation of future conditions. While our warranty costs have historically been within our expectations and the provisions established, to the extent we experience an increased number of warranty claims or increased costs associated with servicing those claims, our warranty expenses will increase, and we may experience decreased gross profit and cash flow. Income Taxes
Our provision for income taxes is composed of a current and a deferred portion. The current income tax provision is calculated as the estimated taxes payable or refundable on tax returns for the current year. The deferred income tax provision is calculated for the estimated future tax effects attributable to temporary differences and carryforwards using expected tax rates in effect in the years during which the differences are expected to reverse.
Effective January 1, 2007, we adopted the FASB guidance related to accounting for uncertainty in income taxes. The updated guidance clarifies the accounting for uncertainty in income taxes recognized in an enterprise's financial statements and prescribes a recognition threshold of more-likely-than-not to be sustained upon examination. Upon adoption of this update, our policy to include interest and penalties related to gross unrecognized tax benefits within our provision for income taxes did not change. We did not accrue interest expense related to these unrecognized tax benefits due to our historical carryforward loss position, the uncertain benefits have not yet reduced taxes payable and, accordingly, no interest expense has been accrued. Results of Operations
The following tables present, for the periods indicated, financial information expressed as a percentage of revenue and a summary of our total revenue. This information has been derived from our condensed consolidated statements of income included elsewhere in this Quarterly Report on Form 10-Q. You should not draw any conclusions about our future results from the results of operations for any period.

                                                        Three Months Ended                           Nine Months Ended
                                               October 3,             September 27,          October 3,           September 27,
                                                  2009                    2008                  2009                  2008
Revenue                                                100 %                     100 %               100 %                   100 %
Costs of revenue                                        26                        25                  25                      25

Gross margin                                            74                        75                  75                      75

Operating expenses:
Research and development                                16                        17                  15                      16
Sales and marketing                                     39                        51                  41                      46
General and administrative                              20                        16                  19                      16

Total operating expenses                                75                        84                  75                      78

(Loss) income from operations                           (1 )                      (9 )                 0                      (3 )
Interest income, net                                    (1 )                       -                   0                       -
Gain on valuation of warrants                            4                         -                   1                       -
Impairment loss on investments                           -                        (3 )                 -                      (1 )
Gain on repurchase of debt                               -                        24                   4                      13

Income before income taxes                               2                        12                   5                       9
Provision for incomes taxes                              3                         8                   3                       5

Net income                                              (1 )%                      4 %                 2 %                     4 %


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Three and Nine Months Ended October 3, 2009 Compared with the Three and Nine
Months Ended September 27, 2008

                                                  Three Months Ended                                             Nine Months Ended
                                                                           Percentage                                                     Percentage
                                October 3,          September 27,           Increase           October 3,          September 27,           Increase
. . .
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