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| GPRO > SEC Filings for GPRO > Form 10-Q on 5-Nov-2009 | All Recent SEC Filings |
5-Nov-2009
Quarterly Report
Product sales for the first nine months of 2009 were $348.3 million, compared
to $323.5 million in the same period of the prior year, an increase of 8%. Total
revenues for the first nine months of 2009 were $359.4 million, compared to
$363.6 million in the same period of the prior year, a decrease of 1%. Net
income for the first nine months of 2009 was $67.8 million ($1.31 per diluted
share), compared to $85.8 million ($1.56 per diluted share) in the same period
of the prior year, a decrease of 21%.
Our total revenues, net income and fully diluted earnings per share in the
first nine months of 2009 included $8.2 million of additional one-time revenue
associated with the renegotiation of our collaboration agreement with Novartis,
as well as Tepnel's results of operations which were not included in the
comparable prior year period. In contrast, the first nine months of 2008
included $16.4 million in royalty and license revenue associated with a third
and final settlement payment from Bayer (now Siemens Healthcare Diagnostics)
which was recorded in the first quarter of 2008, and a $10.0 million development
milestone paid by Novartis, which was recorded in the third quarter of 2008.
Acquisition of Prodesse, Inc.
On October 6, 2009, we entered into a merger agreement with Prodesse, Inc.,
or Prodesse, a privately held Wisconsin corporation. Under the terms of the
merger agreement, we acquired Prodesse on October 21, 2009 for approximately
$60.0 million. A portion of the closing payment was set aside in an escrow
account that will be available for 18 months following the acquisition to
indemnify us for various matters, including for breaches of representations and
warranties and covenants by Prodesse included in the merger agreement. We may
also be required to make additional cash payments to former Prodesse
securityholders of up to an aggregate of $25.0 million in the event certain
milestones set forth in the merger agreement are achieved. As a result of the
acquisition, Prodesse (which is now known as Gen-Probe Prodesse, Inc.) has
become a wholly owned subsidiary of Gen-Probe. We financed the acquisition
through existing cash on hand.
Spin-off of Industrial Testing Assets to Roka Bioscience, Inc.
In September 2009, we announced the spin-off of our industrial testing
assets, including the Closed Unit Dose Assay, or CUDA system, to Roka
Bioscience, Inc., or Roka, a newly formed private company. In consideration for
our contribution of assets, we received shares of preferred stock representing
19.9% of Roka's capital stock on a fully diluted basis. In connection with the
transaction, 18 of our former employees accepted employment with Roka. We will
provide contract manufacturing and certain other services to Roka on a
transitional basis and have agreed to lease a portion of our San Diego
headquarters facility to Roka on a temporary basis. Concurrently with the
transaction, we entered into an agreement to license certain rights to Roka in
order for Roka to develop, manufacture and commercialize the CUDA system and
related nucleic acid tests for biopharmaceutical production, water and food
safety testing, and veterinary, environmental and bioterrorism testing. Roka
will also have rights to develop certain infection control tests for use on the
CUDA system. Under this license agreement, we will receive royalties on any
potential Roka product sales that incorporate Gen-Probe licensed technology. As
part of the spin-off transaction, our industrial testing collaboration
agreements with GE Water (a division of GE Energy, a business unit of General
Electric) and Millipore Corporation were transferred to Roka.
Stock Repurchase Program
In August 2008, our Board of Directors authorized the repurchase of up to
$250.0 million of our common stock over the two years following adoption of the
program, through negotiated or open market transactions. There is no minimum or
maximum number of shares to be repurchased under the program. During the three
months ended September 30, 2009, we repurchased and retired approximately
1,806,000 shares under this program at an average price of $38.35, or
approximately $69.3 million in total. From its inception through September 30,
2009, we have repurchased and retired approximately 5,989,000 shares under this
program at an average price of $41.72, or approximately $249.8 million in total.
As a result, our stock repurchase program was substantially complete as of
September 30, 2009.
Critical accounting policies and estimates
Our discussion and analysis of our financial condition and results of
operations is based on our consolidated financial statements, which have been
prepared in accordance with United States generally accepted accounting
principles, or U.S. GAAP. The preparation of these consolidated financial
statements requires us to make estimates and judgments that affect the reported
amounts of assets, liabilities, revenues and expenses and the related disclosure
of contingent assets and liabilities. On an ongoing basis, we evaluate our
estimates, including those related to revenue recognition, the collectability of
accounts receivable, and the valuation of the following: stock-based
compensation; marketable securities; equity investments in publicly and
privately held companies; income tax; liabilities associated with employee
benefit costs; inventories; and goodwill and long-lived assets, including patent
costs, capitalized software, purchased intangibles and licenses and
manufacturing access fees. We base our estimates on historical experience and on
various other assumptions that are believed to be reasonable under the
circumstances, which form the basis for making judgments about the carrying
values of assets and liabilities. Senior management has discussed the
development, selection and disclosure of these estimates with the Audit
Committee of our Board of Directors. Actual results may differ from these
estimates.
We believe there have been no significant changes during the third quarter of
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, except for the items discussed below.
Marketable securities
The primary objectives of our marketable security investment portfolio are
liquidity and safety of principal. Investments are made with the goal of
achieving the highest rate of return consistent with these two objectives. Our
investment policy limits investments to certain types of debt and money market
instruments issued by institutions primarily with investment grade credit
ratings and places restrictions on maturities and concentration by type and
issuer.
We periodically review our marketable securities for other-than-temporary
declines in fair value below the cost basis, or whenever events or circumstances
indicate that the carrying amount of an asset may not be recoverable. When
assessing marketable securities for other-than-temporary declines in value, we
consider factors including: the significance of the decline in value compared to
the cost basis; the underlying factors contributing to a decline in the prices
of securities in a single asset class; how long the market value of the
investment has been less than its cost basis; any market conditions that impact
liquidity; the views of external investment managers; any news or financial
information that has been released specific to the investee; and the outlook for
the overall industry in which the investee operates.
We do not consider our investments in marketable securities with a current
unrealized loss position to be other-than-temporarily impaired at September 30,
2009 because we do not intend to sell the investments and it is not more likely
than not that we will be required to sell the investments before recovery of
their amortized cost. However, investments in an unrealized loss position deemed
to be temporary at September 30, 2009 that have a contractual maturity of
greater than 12 months have been classified as non-current marketable securities
under the caption "Marketable securities, net of current portion," reflecting
our current intent and ability to hold such investments to maturity. We have
determined that our investments in municipal securities should be classified as
available-for-sale.
Adoption of recent accounting pronouncements
FASB ASC 105
Effective September 30, 2009, we adopted Financial Accounting Standards
Board, or FASB, guidance which establishes the FASB Accounting Standards
Codification, or ASC or the Codification. The Codification supersedes all
existing accounting standard documents and became the single source of
authoritative non-governmental U.S. GAAP. All other accounting literature not
included in the Codification is considered non-authoritative. Because this
statement relates specifically to disclosure requirements, there was no impact
on our consolidated financial statements as a result of the adoption of the
Codification.
FASB ASC 855
Effective June 30, 2009, we adopted FASB guidance requiring disclosure of the
date through which subsequent events have been evaluated for disclosure and
recognition. Because this guidance relates specifically to disclosure
requirements, there was no impact on our consolidated financial statements as a
result of the adoption of this guidance.
Results of Operations
Product sales
(Dollars in millions) Three Months Ended September 30, Nine Months Ended September 30,
2009 2008 $ Change % Change 2009 2008 $ Change % Change
Clinical diagnostics $ 69.6 $ 55.6 $ 14.0 25 % $ 196.6 $ 165.3 $ 31.3 19 %
Blood screening 45.4 52.7 (7.3 ) (14 )% 144.1 158.2 (14.1 ) (9 )%
Research products and
services 4.0 - 4.0 N/M 7.6 - 7.6 N/M
Product sales $ 119.0 $ 108.3 $ 10.7 10 % $ 348.3 $ 323.5 $ 24.8 8 %
As a percent of total
revenues 97 % 89 % 97 % 89 %
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Our primary source of revenue comes from product sales, which consist
primarily of the sale of clinical diagnostic and blood screening products in the
United States and throughout the world. Our clinical diagnostic product sales
consist primarily of our APTIMA, PACE, AccuProbe and Amplified Mycobacterium
Tuberculosis Direct Test product lines, as well as sales of transplant
diagnostics and genetic testing products acquired as part of our acquisition of
Tepnel, which are primarily sold under the LIFECODES and Elucigene trademarks.
The principal customers for our clinical diagnostics products include reference
laboratories, public health institutions and hospitals. The blood screening
assays and instruments we manufacture are marketed and distributed worldwide
through our collaboration with Novartis under the Procleix and Ultrio
trademarks.
We recognize product sales from the manufacture and shipment of tests for
screening donated blood at the contractual transfer prices specified in our
collaboration agreement with Novartis for sales to end-user blood bank
facilities located in countries where our products have obtained governmental
approvals. Blood screening product sales are then adjusted monthly corresponding
to Novartis' payment to us of amounts reflecting our ultimate share of net
revenue from sales by Novartis to the end user, less the transfer price revenues
previously recorded. Net sales are ultimately equal to the sales of the assays
by Novartis to third parties, less freight, duty and certain other adjustments
specified in our collaboration agreement with Novartis multiplied by our share
of the net revenue.
Product sales increased by 10% and 8% in the three and nine months ended
September 30, 2009, respectively, as compared to the same periods of 2008. In
each case, the increase was primarily attributed to additional product sales as
a result of our acquisition of Tepnel and higher APTIMA assay sales, partially
offset by lower blood screening sales, primarily due to lower shipments and
unfavorable exchange rate impacts.
Diagnostic product sales
The increase in diagnostic product sales in the three and nine months ended
September 30, 2009 compared to the same periods of the prior year is primarily
attributed to the addition of transplant diagnostic and genetic testing product
sales resulting from our acquisition of Tepnel, volume gains in our APTIMA
product line as the result of PACE conversions, market share gains we attribute
to the superior clinical performance of our APTIMA assays, and the availability
of our fully automated TIGRIS instrument.
In general, the price of our amplified APTIMA test is twice that of our
non-amplified PACE product, thus the conversion from PACE to APTIMA drives an
overall increase in product sales even if underlying testing volumes remain the
same.
During the three and nine months ended September 30, 2009, diagnostic product
sales were negatively affected as compared to the prior year period by
unfavorable estimated exchange rate impacts of $0.8 million and $3.5 million,
respectively, due to a stronger United States dollar.
Blood screening related sales
The decrease in blood screening sales in the three and nine months ended
September 30, 2009 compared to the same periods of the prior year is primarily
attributed to test demand fluctuations from our partner Novartis and the
unfavorable impact of foreign currency exchange rates. In the third quarter of
2009, blood screening shipments to Novartis were $7.9 million lower than the
third quarter of 2008, primarily associated with lower U.S. shipments of the
Procleix HIV-1/HCV assay as customers began to adopt the Procleix Ultrio assay,
lower U.S. shipments of the Procleix Ultrio assay due to the post-marketing
yield study which concluded at the end of 2008, and lower WNV test shipments. In
addition to these factors, the decrease in blood screening sales for the first
nine months of the year was also caused by a $2.6 million historical revenue
adjustment that was recorded in the prior year period.
During the three and nine months ended September 30, 2009, blood screening
related product sales were negatively affected as compared to the prior year
period by unfavorable estimated exchange rate impacts of $1.7 million and
$7.6 million, respectively, due to a stronger United States dollar.
Research products and services
As a result of our acquisition of Tepnel, we have a new category of product
sales, which we refer to as "Research products and services." These sales
represent outsourcing services for pharmaceutical, biotechnology, and healthcare
industries, including nucleic acid purification and analysis services, as well
as the sale of monoclonal antibodies and food testing kits. These sales totaled
$4.0 million and $7.6 million, respectively, for the three and nine months ended
September 30, 2009.
Collaborative research revenue
(Dollars in millions) Three Months Ended September 30, Nine Months Ended September 30,
2009 2008 $ Change % Change 2009 2008 $ Change % Change
Collaborative
research revenue $ 2.0 $ 11.3 $ (9.3 ) (82 )% $ 5.9 $ 18.5 $ (12.6 ) (68 )%
As a percent of total
revenues 2 % 9 % 2 % 5 %
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We recognize collaborative research revenue over the term of various
collaboration agreements, as negotiated monthly contracted amounts are earned,
in relative proportion to the performance required under the contracts, or as
reimbursable costs are incurred related to those agreements. Non-refundable
license fees are recognized over the related performance period or at the time
that we have satisfied all performance obligations. Milestone payments are
recognized as revenue upon the achievement of specified milestones. In addition,
we record as collaborative research revenue shipments of blood screening
products in the United States and other countries in which the products have not
received regulatory approval. This is done because restrictions apply to these
products prior to FDA marketing approval in the United States and similar
approvals in foreign countries.
The costs associated with collaborative research revenue are based on fully
burdened full-time equivalent rates and are reflected in our consolidated
statements of income under the captions "Research and development," "Marketing
and sales" and "General and administrative," based on the nature of the costs.
We do not separately track all of the costs applicable to collaborations and,
therefore, are not able to quantify all of the direct costs associated with
collaborative research revenue.
Collaborative research revenue decreased 82% in the third quarter of 2009
compared to the third quarter of 2008. This decrease was primarily due to a
non-recurring $10.0 million milestone payment received from Novartis in the
prior year period.
Collaborative research revenue decreased 68% in the nine months ended
September 30, 2009 compared to the same period of the prior year. This decrease
was primarily due to a non-recurring $10.0 million milestone payment received
from Novartis in the prior year period and $4.1 million of revenue received from
3M Corporation, or 3M, related to our healthcare-associated infection
collaboration which ended in September 2008. These decreases were partially
offset by increased reimbursements from Novartis for shared development
expenses, primarily attributable to development efforts for the Panther
. . .
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