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| LMNX > SEC Filings for LMNX > Form 10-Q on 8-May-2009 | All Recent SEC Filings |
8-May-2009
Quarterly Report
• dependence on strategic partners for development, commercialization and distribution of products;
• the impact of the ongoing uncertainty in global finance markets on us and our strategic partners and their customers, including its effects on their capital spending policies and their ability to finance purchases of our products;
• concentration of our revenue in a limited number of strategic partners;
• fluctuations in quarterly results due to a lengthy and unpredictable sales cycle, bulk purchases of consumables, and the seasonal nature of some of our assay products;
• our ability to scale manufacturing operations and manage operating expenses, gross margins and inventory levels;
• potential shortages, or increases in costs, of components;
• competition;
• our ability to successfully launch new products;
• the timing of regulatory approvals;
• the implementation, including any modification, of our strategic operating plans;
• the uncertainty regarding the outcome or expense of any litigation brought against or initiated by us;
• risks relating to our foreign operations; and
• risks and uncertainties associated with implementing our acquisition strategy including our ability to obtain financing, our ability to integrate acquired companies or selected assets into our consolidated business operations, and the ability to recognize the benefits of our acquisitions.
Many of these risks, uncertainties and other factors are beyond our control and
are difficult to predict. Any or all of our forward-looking statements in this
report may turn out to be inaccurate. We have based these forward-looking
statements largely on our current expectations and projections about future
events and financial trends that we believe may affect our financial condition,
results of operations, business strategy and financial needs. New factors could
also emerge from time to time that could adversely affect our business. The
forward-looking statements herein can be affected by inaccurate assumptions we
might make or by known or unknown risks, uncertainties and assumptions,
including the risks, uncertainties and assumptions outlined above and described
in the section titled "Risk Factors" below and in the 2008 10-K. In light of
these risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this report may not occur and actual results could
differ materially from those anticipated or implied in the forward-looking
statements. When you consider these forward-looking statements, you should keep
in mind these risk factors and other cautionary statements in this report and
our other annual and periodic reports.
Our forward-looking statements speak only as of the date made. We undertake no
obligation to publicly update or revise forward-looking statements, whether as a
result of new information, future events or otherwise. All subsequent written
and oral forward-looking statements attributable to us or persons acting on our
behalf are expressly qualified in their entirety by the cautionary statements
contained in this report.
Unless the context requires otherwise, references in this Quarterly Report on
Form 10-Q to "Luminex," the "Company," "we," "us" and "our" refer to Luminex
Corporation and its subsidiaries.
OVERVIEW
We develop, manufacture and sell proprietary biological testing technologies and
products with applications throughout the life sciences and diagnostics
industries. These industries depend on a broad range of tests, called bioassays,
to perform diagnostic tests, discover and develop new drugs and identify genes.
Our xMAP® (Multi-Analyte Profiling) technology, an open architecture,
multiplexing technology, allows simultaneous analysis of up to 100 bioassays
from a small sample volume, typically a single drop of fluid, by reading
biological tests on the surface of microscopic polystyrene beads called
microspheres. Products we are currently developing and that are anticipated for
market release in 2009 will be able to perform up to 500 simultaneous bioassays
from a small sample volume. xMAP technology combines this miniaturized liquid
array bioassay capability with small lasers, digital signal processors and
proprietary software to create a system offering advantages in speed, precision,
flexibility and cost. Our xMAP technology is currently being used within various
segments of the life sciences industry which includes the fields of drug
discovery and development, clinical diagnostics, genetic analysis, bio-defense,
protein analysis and biomedical research.
Our end-user customers and partners, which include laboratory professionals
performing research, clinical laboratories performing tests on patients as
ordered by a physician and other laboratories, have a fundamental need to
perform high quality testing as efficiently as possible. Luminex has adopted a
business model built around strategic partnerships. We have licensed our xMAP
technology to companies, which then develop products that incorporate the xMAP
technology into products that they sell to the end-user. Luminex develops and
manufactures the proprietary xMAP laboratory instrumentation and the proprietary
xMAP microspheres and sells these products to its partners. Our partners then
sell xMAP instrumentation and xMAP-based reagent consumable products, which run
on the instrumentation, to the end-user laboratory. Luminex was founded on this
model, and our success to date has been due to this model. As of March 31, 2009,
Luminex had approximately 61 strategic partners and these partners have
purchased from Luminex over 6,000 xMAP-based systems. Of the 61 strategic
partners, 36 have released commercialized reagent-based products utilizing our
technology.
Beginning in 2006, we began developing proprietary assays. This development was
supplemented in 2007 by our acquisition of Tm Bioscience, which we named Luminex
Molecular Diagnostics, or LMD. Our Assay Segment focuses on the molecular
diagnostics market and certain specialty markets.
Luminex has several forms of revenue that result from this partner model:
• System revenue is generated from the sale of our xMAP systems and
peripherals. Currently, system revenue is derived from the sale of the
Luminex 100 and 200 analyzers, our FLEXMAP 3D system, optional XY Platform
and Sheath Delivery Systems.
• Consumable revenue is generated from the sale of our dyed polystyrene microspheres and sheath fluid. Our larger commercial and development partners often purchase these consumables in bulk to minimize the number of incoming qualification events and to allow for longer development and production runs.
• Royalty revenue is generated when a partner sells a kit incorporating our proprietary microspheres to an end user or when a partner utilizes a kit to provide a testing result to a user. End users can be facilities such as testing labs, development facilities and research facilities that purchase prepared kits and have specific testing needs or testing service companies that provide assay results to pharmaceutical research companies or physicians.
• Assay revenue is generated from the sale of our kits which are a combination of chemical and biological reagents and our proprietary bead technology used to perform diagnostic and research assays on samples.
• Service revenue is generated when a partner or other owner of a system purchases a service contract from us after the warranty has expired. Service contract revenue is amortized over the life of the contract and the costs associated with those contracts are recognized as incurred.
• Other revenue consists of items such as training, shipping, parts sales, license revenue, grant revenue, contract research and development fees, milestone revenue and other items that individually amount to less than 5% of total revenue.
First Quarter 2009 Highlights
• Consolidated revenue of $25.6 million for the quarter ended March 31,
2009, representing an 11% increase over revenue for the first quarter of
2008
• Consolidated gross profit margin of 69% compared with first quarter 2008 gross profit margin of 66%
• System shipments of 203 including 2 shipments of FLEXMAP 3D™, representing the tenth consecutive quarter of system shipments of 200 or more and resulting in cumulative life-to-date shipments of 6,097
• First quarter consumables revenue of $7.6 million and royalty revenue of $4.5 million
• Our partners reported over $65 million of royalty bearing end user sales on xMAP technology for the quarter, a 21% increase over the first quarter of 2008
• Settlement of SUNY lawsuit, resulting in one-time charge of approximately $4.4 million
We have experienced a decrease in sequential total revenue from the fourth
quarter of 2008 of approximately 9%, or $2.6 million. This decrease was a result
of several factors.
• The historical decline in system placements from each fourth quarter to
the first quarter of the subsequent year that we have consistently
experienced, primarily attributable to customer spending behavior. The
variability in customer spending patterns is one of the factors
contributing to the broad range of expected system placements we have
communicated of between 175 and 225 LX100/200 systems per quarter.
• The decline in bulk consumable purchases in the first quarter of 2009. In the fourth quarter of 2008, we had bulk purchases totaling $6.8 million in consumables. In the first quarter of 2009, bulk purchases constituted $6.1 million of consumables, primarily as a result of one less bulk purchaser in the first quarter. We have previously indicated that variability is expected in the absolute number of bulk purchasers and purchases per quarter and we expect this variability to continue. Non-bulk purchases for the same periods remained essentially unchanged at approximately $1.5 million.
• The decline in total assay revenue from $5.4 million in the fourth quarter of 2008 to $4.2 million in the first quarter of 2009. The decline in total assay revenue is a result of expected volatility in individual assay sales coupled with a lighter than anticipated flu season, resulting in xTAG RVP sales falling below expectations. Assay volatility will continue to exist as our customers buy product to meet current expected needs and manage their inventory, and as a result of economic and other external conditions that may impact a particular product, such as a mild flu season with respect to our xTAG RVP products. In the aggregate, we do not believe that our anticipated assay sales will experience any long term decline based on the first quarter results and experience, and with the introduction of new products currently in the pipeline, assay sales are expected to grow long term.
Segment Information
Luminex has two reportable segments: the Technology Segment and the Assay
Segment. The Technology Segment, which is our base business, consists of system
sales to partners, raw bead sales, royalties, service and support of the
technology, and other miscellaneous items. The Assay Segment is primarily
involved in the development and sale of assays on xMAP technology for use on
Luminex's installed base of systems.
Future Operations
We expect anticipated 2009 revenue growth to be driven by sustained adoption of
our core technology coupled with assay introduction and commercialization by the
Assay Segment. We anticipate a continued shift in revenue concentration towards
the higher margin items, such as assays, consumables and royalties, which will
remain a significant portion of our revenue mix, contributing to favorable, but
variable gross margin percentages. Additionally, we believe that a sustained
investment in R&D is necessary in order to meet the needs of our marketplace;
however, we estimate that R&D expenditures for the year ended December 31, 2009
will decline as a percentage of revenue from 18% in 2008 towards our long term
target of 15% of revenue. We could experience volatility in R&D expenses as a
percentage of revenue on a quarterly basis.
We expect our primary challenges throughout the remainder of 2009 to be the
continued adoption of partner products incorporating Luminex technology, the
current economic condition and its potential impact on the purchases and sales
of our partners and customers, our ability to improve or maintain our operating
margins, commercialization, regulatory acceptance and market adoption of output
from the Assay Segment, our ability to manage our costs, and the expansion of
our footprint and reputation within our identified target market segments.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The discussion and analysis of our financial condition and results of operations
are based upon our condensed consolidated financial statements, which have been
prepared in accordance with United States generally accepted accounting
principles for interim financial statements. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported
amounts of assets, liabilities, revenues and expenses, and related disclosure of
contingent assets and liabilities. We base our estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. Estimates and assumptions are reviewed
periodically. Actual results may differ from these estimates under different
assumptions or conditions.
Management believes there have been no significant changes during the quarter
ended March 31, 2009 to the items that we disclosed as our critical accounting
policies and estimates in Management's Discussion and Analysis of Financial
Condition and Results of Operations in our Annual Report on Form 10-K for the
year ended December 31, 2008.
RESULTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2009 COMPARED TO THREE MONTHS ENDED MARCH 31, 2008
Selected consolidated financial data for the three months ended March 31, 2009
and 2008 is as follows (dollars in thousands):
Three Months Ended
March 31,
2009 2008
Revenue $ 25,557 $ 23,012
Gross profit $ 17,568 $ 15,257
Gross profit margin percentage 69 % 66 %
Operating expenses $ 15,984 $ 16,525
Income (loss) from operations $ 1,584 $ (1,268 )
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Total revenue increased by 11% to $25.6 million for the three months ended
March 31, 2009 from $23.0 million for the comparable period in 2008. The
increase in revenue was primarily attributable to growth in consumable and
royalty revenues in the Technology Segment as a result of the expansion of the
installed instrument base and the corresponding increased aggregate consumption
which contributed $2.1 million or 81% of the overall increase. System sales for
the first quarter of 2009 decreased to 203 Systems from 220 Systems for the
corresponding prior year period bringing total system sales since inception to
6,097 as of March 31, 2009.
A breakdown of revenue for the three months ended March 31, 2009 and 2008 is as
follows (in thousands):
Three Months Ended
March 31,
2009 2008
System sales $ 6,127 $ 6,627
Consumable sales 7,603 6,554
Royalty revenue 4,527 3,518
Assay revenue 4,195 3,846
Service contracts 1,432 1,219
Other revenue 1,673 1,248
$ 25,557 $ 23,012
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We continue to experience revenue concentration in a limited number of strategic
partners. Two customers accounted for 34% of consolidated total revenue in the
first quarter of 2009 (21% and 13%, respectively). For comparative purposes,
these same two customers accounted for 32% of total revenue (17% and 15%,
respectively) in the first quarter of 2008. No other customer accounted for more
than 10% of total revenue in this quarter.
Gross profit margin percentage increased to 69% for the three months ended
March 31, 2009 from 66% for the comparable period in 2008 due to the continued
shift in revenue concentration towards higher margin items: consumables and
royalties. The decrease in operating expenses from $16.5 million for the first
quarter of 2008 to $16.0 million for the three months ended March 31, 2009
reflects our cost containment efforts. Net operating income increased due to the
increase in revenue and gross profit margin percentage. See additional
discussions by segment below.
Technology Segment
Selected financial data for our Technology Segment for the three months ended
March 31, 2009 and 2008 is as follows (dollars in thousands):
Three Months Ended
March 31,
2009 2008
Revenue $ 21,098 $ 18,656
Gross profit $ 14,583 $ 11,989
Gross profit margin percentage 69 % 64 %
Operating expenses $ 11,065 $ 11,090
Income from operations $ 3,518 $ 899
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Revenue. Total revenue for our Technology Segment increased by 13% to
$21.1 million for the three months ended March 31, 2009 from $18.7 million for
the comparable period in 2008. The increase in revenue was primarily
attributable to an increase in consumable and royalty revenue as a result of the
expansion of the installed instrument base and the corresponding increased
aggregate consumption. Two customers accounted for 41% of total Technology
Segment revenue in the first quarter of 2009 (25% and 16%, respectively). For
comparative purposes, these same two customers accounted for 40% of total
Technology Segment revenue (21% and 19%, respectively) in the first quarter of
2008.
A breakdown of revenue in the Technology Segment for the three months ended
March 31, 2009 and 2008 is as follows (in thousands):
Three Months Ended
March 31,
2009 2008
System sales $ 6,011 $ 6,163
Consumable sales 7,590 6,545
Royalty revenue 4,527 3,518
Service contracts 1,372 1,219
Other revenue 1,598 1,211
$ 21,098 $ 18,656
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System and peripheral component sales decreased by 2% to $6.0 million for the
three months ended March 31, 2009 from $6.2 million for the comparable period of
2008. The Technology Segment sold 199 of the 203 total system sales in the three
months ended March 31, 2009. For the three months ended March 31, 2009, five of
our partners accounted for 132, or 66%, of total Technology Segment system sales
for the period. The top five partners purchased 162, or 74%, of total Technology
Segment system sales in the three months ended March 31, 2008.
Consumable sales, comprised of microspheres and sheath fluid, increased 16% to
$7.6 million for the three months ended March 31, 2009 from $6.5 million for the
three months ended March 31, 2008. This is primarily the result of an increase
in bulk purchases due to increased commercial activity by our partners. A bulk
purchase is defined as the purchase of $100,000 or more of consumables in a
quarter. During the three months ended March 31, 2009, we had 11 bulk purchases
of consumables totaling approximately $6.1 million as compared with 11 bulk
purchases totaling approximately $5.2 million in the three months ended
March 31, 2008. Partners who reported royalty bearing sales accounted for
$6.6 million, or 87%, of total consumable sales for the three months ended
March 31, 2009.
Royalty revenue, which results when our partners sell products or services
incorporating our technology, increased by 29% to $4.5 million for the three
months ended March 31, 2009 compared with $3.5 million for the three months
ended March 31, 2008. We believe this is primarily the result of our efforts to
accelerate instrument placements, menu expansion, and increased utilization of
our partners' assays on our technology. We expect modest fluctuations in the
number of commercial partners submitting royalties quarter to quarter based upon
the varying contractual terms, consolidations among partners, differing
reporting and payment requirements, and the addition of new partners. For the
three months ended March 31, 2009, we had 36 commercial partners submitting
royalties as compared to 31 for the three months ended March 31, 2008. One of
our partners reported royalties totaling approximately $1.5 million or 32% of
total royalties for the current quarter compared to $950,000 or 25% for the
quarter ended March 31, 2008. Two other customers reported royalties totaling
approximately $949,000 or 21% (12% and 9%, respectively) of total royalties for
the current quarter. No other customer accounted for more than 10% of total
royalty revenue for the current quarter. Total royalty bearing sales reported to
us by our partners were over $65 million for the quarter ended March 31, 2009
compared with over $53 million for the quarter ended March 31, 2008.
Service contracts revenue, comprised of extended warranty contracts earned
ratably over the term of a contract, increased by 13% to $1.4 million for the
first quarter of 2009 from $1.2 million for the first quarter of 2008. This
increase is attributable to additional resources allocated to the sale of
extended service agreements resulting in increased penetration of the expanded
installed base. At March 31, 2009, we had 1,016 Luminex systems covered under
extended service agreements and $2.5 million in deferred revenue related to
those contracts. At March 31, 2008, we had 841 Luminex systems covered under
extended service agreements and $2.3 million in deferred revenue related to
those contracts.
Other revenues, comprised of training revenue, shipping revenue, miscellaneous
part sales, amortized license fees, reagent sales, and grant revenue, increased
by 32% to $1.6 million for the three months ended March 31, 2009 from
$1.2 million for the three months ended March 31, 2008. This increase is
primarily the result of an increase in grant revenue.
Gross profit. The gross profit margin percentage (gross profit as a percentage
of total revenue) for the Technology Segment increased to 69% for the three
months ended March 31, 2009 from 64% for the three months ended March 31, 2008.
Gross profit for the Technology Segment increased to $14.6 million for the three
months ended March 31, 2009, as compared to $12.0 million for the three months
ended March 31, 2008. The increase in gross profit margin percentage was
primarily attributable to changes in revenue mix between our higher and lower
gross margin items. The increase in gross profit was primarily attributable to
the overall increase in revenue coupled with the increase in gross margin.
Consumables and royalties, two of our higher margin items, comprised
$12.1 million, or 57%, of Technology Segment revenue for the current quarter and
$10.1 million, or 54%, of Technology Segment revenue for the quarter ended
March 31, 2008.
Research and development expense. Research and development expenses for the
Technology Segment decreased to $2.5 million for the three months ended
March 31, 2009 from $2.7 million for the comparable period in 2008. The slight
decrease was primarily related to the timing of expenses related to our various
R&D projects, while headcount remained flat compared to the three months ended
March 31, 2008.
Selling, general and administrative expense. Selling, general and administrative
expense for the Technology Segment increased to $8.5 million for the three
months ended March 31, 2009 from $8.4 million for the comparable period in 2008.
Other income, net. Other income increased to $877,000 for the three months ended
March 31, 2009 from $320,000 for the comparable period in 2008. The increase is
due to the interest income on the net proceeds from our secondary offering
offset by the decrease in the average rate earned on current invested balances
which decreased to 1.0% at March 31, 2009 from 3.7% at March 31, 2008. This
decrease in the average rate earned is the result of an overall decrease in
market rates compared to the prior year period.
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