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Quotes & Info
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| ASPM > SEC Filings for ASPM > Form 10-Q on 8-Nov-2007 | All Recent SEC Filings |
8-Nov-2007
Quarterly Report
Date of
Initial Clearance
Commercial of 510 (k)
Product Shipment Notification Description
EQUIPMENT
BIS VIEW 2007 August 2007 Basic-featured standalone monitor which has
fewer optional user configurations compared
with the BIS VISTA monitor.
BIS VISTA 2006 September 2005 Monitor that offers an enhanced display and
user interface as well as greater processing
capability compared to our other monitors.
BISx system 2004 February 2004 BIS monitoring solution that provides the
processing technology required to obtain BIS
information from a single device the
approximate size of a hockey puck. The BISx
system is designed to integrate with a wide
range of patient monitoring platforms sold by
original equipment manufacturers.
BIS XP System 2001 June 2001 BIS system offering enhanced performance
capabilities and expanded benefits as
compared to the previous version of the BIS
system, designed to enable more precise
measurement of brain activity to assess the
level of consciousness.
BIS Module Kit - 2001 October 2000 Same as standard BIS Module Kit plus 4
4 Channel channel EEG monitoring capability.
Support
A-2000 BIS 1998 February 1998 Compact, lightweight, portable
Monitor third-generation BIS monitor.
BIS Module Kit 1998 October 2000 Components of BIS monitoring technology that
are integrated into equipment sold by
original equipment manufacturers.
SENSORS
Semi-Reusable 2005 February 2005 Semi-reusable version of a BIS Sensor that
(SRS) Sensor uses the same algorithm and hardware as our
other disposable sensors. Currently available
only in markets outside the United States,
excluding Japan.
BIS Extend 2002 October 2000 Disposable sensor with electronic memory
Sensor device for use with our BIS Monitors, BIS
Module Kit and BISx System that was designed
for patients who are typically monitored for
extended periods.
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Date of
Initial Clearance
Commercial of 510 (k)
Product Shipment Notification Description
BIS Pediatric Sensor 2001 October 2000 Disposable sensor with electronic memory
device for use with our BIS Monitors, BIS
Module Kit and BISx System that is smaller
and easier to apply to children.
BIS Quatro Sensor 2001 October 2000 Disposable sensor with electronic memory
device for use with our BIS Monitors, BIS
Module Kit and BISx System that is designed
to offer enhanced performance in deep
anesthetic states and enhanced resistance to
interference from noise sources.
BIS Sensor Plus 2001 January 2000 Second-generation disposable sensor for use
with our BIS Monitors and BIS Module Kit.
BIS Standard Sensor 1997 October 1996 Disposable sensor for use with our BIS
Monitors and BIS Module Kit.
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We derive our revenue primarily from sales of BIS monitors, 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 Sensors. We have also historically derived a portion of our revenue from our strategic alliances, primarily with Boston Scientific Corporation, which was terminated in June 2007. To assist management in assessing and managing our business, we segregate our revenue by sales by region, sales by products and revenue derived from our strategic alliance, as shown in the following table:
Three Months Ended Nine Months Ended
September 29, September 30, September 29, September 30,
2007 2006 2007 2006
(dollars in thousands)
Domestic revenue $ 16,655 $ 18,031 $ 55,737 $ 52,692
Percent of total revenue 74 % 79 % 76 % 78 %
International revenue $ 5,977 $ 4,824 $ 17,655 $ 14,681
Percent of total revenue 26 % 21 % 24 % 22 %
Total revenue $ 22,632 $ 22,855 $ 73,392 $ 67,373
BIS Sensor revenue $ 19,031 $ 16,126 $ 55,148 $ 47,578
Percent of total revenue 84 % 71 % 75 % 71 %
Equipment revenue $ 3,601 $ 5,019 $ 12,998 $ 15,189
Percent of total revenue 16 % 22 % 18 % 22 %
Strategic alliance revenue $ - $ 1,710 $ 5,246 $ 4,606
Percent of total revenue - 7 % 7 % 7 %
Total revenue $ 22,632 $ 22,855 $ 73,392 $ 67,373
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At September 29, 2007, we had cash, cash equivalents, restricted cash and
investments of approximately $107.0 million and working capital of approximately
$98.8 million.
We follow a system of fiscal quarters as opposed to calendar quarters.
Therefore, the first three quarters of each fiscal year end on the Saturday
closest to the end of the calendar 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 our ability
to sell our Equipment to healthcare organizations and influence our customers
after they purchase our Equipment to continue to purchase and use our BIS
Sensors. We believe the primary reason for the growth in product revenue is a
direct result of continuing to shift the focus of our sales and marketing
emphasis from expanding our customer base to developing our existing customers
and increasing their sensor utilization and procedure penetration. To continue
to achieve this growth, we plan to implement new sales and marketing programs,
particularly in the area of clinical education programs. We expect that as we
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 margin and control the growth of our operating
expenses. To maintain our gross profit margin we believe we must continue to
focus on maintaining the 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 margin 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 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 it is acquired.
Under certain limited circumstances, 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 includes a premium
above the list price of the BIS Sensors to cover the rental of the equipment,
but without any 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 and the United Kingdom 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) and, most recently in 2005, our BIS XP system. 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% of
international revenue in both the three and nine months ended September 29, 2007
and approximately 11% and 12% of international revenue in the three and nine
months ended September 30, 2006, respectively.
During the first quarter of 2006, we adopted Financial Accounting Standards
Board, or FASB, Statement of Financial Accounting Standard, or SFAS, 123
(revised 2004), Share-Based Payment, or SFAS No. 123R, using the modified
prospective transition method. Prior to the adoption of SFAS No. 123R, we
accounted for share-based payments to employees using the intrinsic value method
under Accounting Principles Bulletin, or APB, Opinion No. 25, Accounting for
Stock Issued to Employees, and, as such, generally recognized no compensation
expense for employee stock options. For the three and nine months ended
September 29, 2007, we recognized approximately $2.2 million and $6.5 million,
respectively, of stock-based compensation expense in our condensed consolidated
statements of operations and in the three and nine months ended September 30,
2006, we recognized approximately $1.6 million and $4.9 million 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 our adoption of SFAS No. 123R.
Various factors may adversely affect our quarterly operating results through
the fourth quarter of 2007 and beyond. These factors include the impact of the
shift in our emphasis from expanding our customer base to developing our
existing customer base and increasing their sensor utilization and procedure
penetration, the continued challenges of the worldwide economy and the risk that
we may not realize expected benefits of industry pronouncements on anesthesia
awareness,
including the Sentinel Event Alert issued by the Joint Commission on
Accreditation of Healthcare Organizations, the Practice Advisory on
Interoperative Awareness, which was approved by the American Society of
Anesthesiologists House of Delegates in October 2005 and the position statement
regarding unintended awareness issued by the American Association of Nurse
Anesthetists, or AANA. In addition, in Japan, Nihon Kohden received approval of
the BIS XP system in 2005 and we may not recognize the potential benefits of
this approval for some time, if at all.
Critical Accounting Policies and Estimates
Management's discussion and analysis of financial condition and results of
operations is based upon our condensed consolidated financial statements, which
have been prepared in accordance with accounting principles generally accepted
in the United States. Note 2 of the Notes to Condensed 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 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. Our original equipment manufacturer products are sold to
original equipment manufacturers who in turn sell them 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, Issue
No. 00-21, Revenue Arrangements with Multiple Deliverables. 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 also recognize revenue from prepaid license and royalty fees. This revenue
is deferred until product shipment or delivery in accordance with the terms of
the agreement and license and royalty fees are earned in accordance with the
terms of the respective agreements. In August 2002, we recorded approximately
$6.3 million of deferred revenue related to an OEM product development and
distribution agreement with Boston Scientific Corporation, which we refer to as
the 2002 OEM product development and distribution agreement. In June 2007, we
terminated the 2002 OEM product development and distribution agreement and as a
result, at that time we recognized the remaining $3.8 million that had been
previously deferred under this agreement.
In May 2005, we entered into a product development and distribution agreement
with Boston Scientific Corporation, which we refer to as the 2005 product
development and distribution agreement. Pursuant to this agreement, Boston
Scientific Corporation agreed to provide to us up to $25.0 million to fund the
development of products that incorporate EEG analysis technology for the
diagnosis of neurological, psychiatric or pain disorders or screening or
monitoring patient response to treatment options for such disorders. In
June 2007, we terminated the 2005 product development and distribution agreement
with Boston Scientific Corporation. In connection with the termination of the
agreement, we reversed a receivable of approximately $285,000 that we had
recorded in March 2007 against the strategic alliance revenue where it had
originally been recorded in the statement of income. Revenue was being
recognized on allowable product development activities pursuant to this
agreement as the services were performed and costs were incurred.
We follow SFAS No. 13, Accounting For Leases, 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.
Stock-Based Compensation
SFAS No. 123R, which we adopted in the first quarter of 2006, requires that
stock-based compensation expense associated with equity instruments be
recognized in the condensed consolidated statements of operations, rather than
being disclosed in a pro forma footnote to the condensed consolidated financial
statements. 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 value using the
Black-Scholes valuation model. The use of valuation models requires us to make
estimates with respect to 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 in determining 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 and nine months ended
September 29, 2007. 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 5.0% in our
calculation at September 29, 2007. 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 the amount of restricted stock issued in
future periods.
As of September 29, 2007, the total unrecognized compensation cost related to
unvested stock options and unvested restricted stock awards was $11.2 million
and $5.0 million, respectively, which will be amortized over the weighted
average remaining requisite service periods of 26 months and 36 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, our credit policies 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
. . .
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