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| ASPM > SEC Filings for ASPM > Form 10-Q on 14-May-2009 | All Recent SEC Filings |
14-May-2009
Quarterly Report
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.
We derive our revenue primarily from sales of BIS Sensors, our original
equipment manufacturer products (including BIS Module Kits and the BISx system)
and related accessories, which we collectively refer to as Equipment, and sales
of BIS monitors. 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
April 4, March 29,
2009 2008
Domestic revenue $ 17,095 $ 17,063
Percentage of total revenue 68 % 70 %
International revenue $ 8,205 $ 7,365
Percentage of total revenue 32 % 30 %
Total revenue $ 25,300 $ 24,428
BIS Sensor revenue $ 21,581 $ 20,636
Percentage of total revenue 85 % 84 %
Equipment revenue $ 3,719 $ 3,792
Percentage of total revenue 15 % 16 %
Total revenue $ 25,300 $ 24,428
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At April 4, 2009, we had cash, restricted cash and investments of
approximately $76.2 million and working capital of approximately $93.0 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. We believe the primary reason for the growth in product revenue is a
direct result of the shift of our sales and marketing emphasis from expanding
our customer base to deepening our relationships with our existing customers and
increasing their sensor utilization and procedure penetration. As we seek to
continue to achieve this growth, we have expanded our sales forces and are
implementing 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.
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 14% and 15%, respectively, of our
international revenue in the three months ended April 4, 2009 and March 29,
2008.
We account for share-based payments to employees under Financial Accounting
Standards Board's, or FASB's, Statement of Financial Accounting Standards, or
SFAS, 123 (revised 2004), Share-Based Payment, or SFAS No. 123R. For the three
months ended April 4, 2009 and March 29, 2008, we recognized approximately
$1.5 million and $1.9 million, respectively, of stock-based compensation expense
in our condensed consolidated statements of operations. 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 our adoption of
SFAS No. 123R.
Various factors may adversely affect our quarterly operating results at least
through the second 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 recently 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. We also have shifted the focus of our sales
and marketing efforts from expanding our customer base to deepening our
relationships with our existing customers and increasing their sensor
utilization and procedure penetration. As a result of this shift in focus, we
expect our revenue from the sale of equipment to decrease. Additionally, we have
repurchased a portion of our notes, and may make additional repurchases in the
future. If any such repurchases are made at a discount to the face value of the
notes, we expect to record a gain on such transaction, which could affect our
operating results in the quarter in which any such repurchase is made. 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. Finally, we may not realize expected benefits of favorable industry
pronouncements on anesthesia awareness, including the position statements issued
by the Joint Commission on Accreditation of Healthcare Organizations, the
American Society of Anesthesiologists House of Delegates, and the American
Association of Nurse Anesthetists.
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 then 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. We recognize revenue when earned in accordance with Staff Accounting
Bulletin, or SAB, No. 104, Revenue Recognition, and Emerging Issues Task Force,
or EITF, 00-21, Revenue Arrangements with Multiple Deliverables, or SAB No. 104.
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.
We follow SFAS No. 13, Accounting For Leases, or SFAS No. 13, in connection
with our sales-type lease agreements. 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.
We recognize revenue either at shipment or delivery in accordance with the
agreed upon contract terms with distributors and original equipment
manufacturers in accordance with SAB No. 104. 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
SFAS No. 123R requires that stock-based compensation expense associated with
equity instruments be recognized in the consolidated statement of operations.
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 model. 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 expected term assumption 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
options. We used a combination of our implied volatility and historical
volatility to estimate expected volatility for the three months ended April 4,
2009. We believe that in addition to the relevance of historical volatility,
consideration of implied volatility achieves the objectives of SFAS No. 123R
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. SFAS No. 123R requires forfeitures to be estimated at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates. We used a forfeiture rate of approximately 7.06% in our
calculation at April 4, 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 April 4, 2009, the total unrecognized compensation cost related to
unvested stock options and unvested restricted stock awards was $5,920,000 and
$4,869,000 , respectively, which will be amortized over the weighted average
remaining requisite service periods of 29 months and 30 months, 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.
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 generally is covered by a warranty period of one year.
We accrue a warranty reserve for estimated costs to provide warranty services.
Our estimate of costs to service our warranty obligations is based on our
historical experience and 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 provisions of the Financial
Accounting Standards Board Interpretation No. 48, Accounting for Uncertainty in
Income Taxes - an Interpretation of FASB Statement No. 109, or FIN 48. FIN 48
clarifies the accounting for uncertainty in income taxes recognized in an
enterprise's financial statements in accordance with SFAS No. 109, Accounting
for Income Taxes, or SFAS No. 109, and prescribes a recognition threshold of
more-likely-than-not to be sustained upon examination. Upon adoption of FIN 48,
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 operations 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
April 4, March 29,
2009 2008
Revenue 100 % 100 %
Costs of revenue 23 26
Gross profit 77 74
Operating expenses:
Research and development 16 16
Sales and marketing 43 42
General and administrative 18 16
Total operating expenses 77 74
Loss from operations - -
Interest income, net - 1
Realized gain on sale of investment - -
Gain on repurchases of debt 12 -
Income before income taxes 12 1
Provision for income taxes 5 2
Net income (loss) 7 % (1 )%
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Three Months Ended April 4, 2009 Compared with the Three Months Ended March 29, 2008
Three Months Ended
Percentage
April 4, March 29, Increase
2009 2008 (Decrease)
(in thousands, except
unit amounts)
Revenue - Worldwide
BIS Sensor $ 21,581 $ 20,636 5 %
BIS monitor 1,898 2,097 (9 )
Original equipment manufacturer products 1,013 981 3
Other equipment and accessories 808 714 13
Total equipment 3,719 3,792 (2 )
Total revenue $ 25,300 $ 24,428 4 %
Unit Analysis - Worldwide
BIS Sensors 1,598,000 1,486,000 8 %
BIS monitors 732 718 2
Original equipment manufacturer
BIS products 1,362 1,560 (13 )
Installed base 58,882 49,295 19
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Revenue. Revenue from the sale of BIS Sensors increased approximately 5% in
the three months ended April 4, 2009 compared with the three months ended
March 29, 2008 and the number of BIS Sensors sold increased approximately 8%
during this same period. We believe the increase in revenue from the sale of BIS
Sensors and the number of BIS Sensors sold during this period was primarily
attributable to two factors. First, we have shifted the focus of our sales and
marketing strategy from expanding our customer base to deepening our
relationships with our existing customers and increasing their sensor
utilization and procedure penetration and second, we experienced growth in the
installed base of BIS monitors. The number of domestic sensors sold was
approximately 961,000 during the first quarter of 2008 and increased to
approximately 971,000 during the first quarter of 2009, an increase of
approximately 1%, while the number of international sensors sold increased
approximately 19% from approximately 525,000 during the first quarter of 2008 to
approximately 627,000 during the first quarter of 2009. The average domestic
selling price of our BIS Sensors remained stable. The average international
selling price of our BIS Sensors decreased by approximately 2%. Our installed
base of BIS monitors and original equipment manufacturer products increased
approximately 19% to 58,882 units at April 4, 2009 compared with 49,295 units at
March 29, 2008.
During the three months ended April 4, 2009 compared with the three months
ended March 29, 2008, total Equipment revenue decreased by approximately 2%. The
decrease in Equipment revenue during this period was a result of a decrease of
approximately 9% in BIS monitor revenue offset by an increase of approximately
3% in original equipment manufacturer product revenue and an increase of
approximately 13% in other equipment revenue. The decrease in monitor revenue
was the result of a decrease in the average selling price of approximately 11%
due primarily to a Bilateral Vista monitor promotion which involves trade-ins of
A-2000 BIS monitors at a discounted price for Bilateral Vista monitors that we
implemented during the first quarter of 2009. The increase in original equipment
manufacturer product revenue was a result of an increase in average selling
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