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| GPRO > SEC Filings for GPRO > Form 10-Q on 6-Aug-2009 | All Recent SEC Filings |
6-Aug-2009
Quarterly Report
Our total revenues, net income and fully diluted earnings per share in the
first six months of 2009 included $8.2 million of 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 six months of 2008 included $16.4 million of
royalty and license revenue associated with the settlement payment received from
Bayer (now Siemens Healthcare Diagnostics) which was recorded in the first
quarter of 2008.
Acquisition of Tepnel Life Sciences plc
In April 2009, we completed our acquisition of Tepnel. The acquisition was
consummated pursuant to a court-sanctioned scheme of arrangement under Part 26
of the UK Companies Act 2006. As a result of the acquisition, Tepnel became a
wholly owned subsidiary of Gen-Probe Incorporated.
Upon consummation of the acquisition, each issued ordinary share of Tepnel
was cancelled and converted into the right to receive 27.1 pence in cash, or
approximately $0.40 based on the exchange rate of £1 to $1.48 as of the closing
date. In connection with the acquisition, the holders of issued and outstanding
Tepnel capital stock, options and warrants received total net cash of
approximately £92.8 million, or approximately $137.1 million based on the
exchange rate of £1 to $1.48 as of the closing date. The acquisition was
financed through amounts borrowed under a senior secured revolving credit
facility established with Bank of America, N.A., or Bank of America.`
Amended Collaboration Agreement with DiagnoCure Inc.
In April 2009, we and DiagnoCure, Inc., or DiagnoCure, entered into an
amendment to the License, Development and Cooperation Agreement originally
signed by the parties on November 19, 2003.
Pursuant to the amendment, we agreed to use our commercially reasonable
efforts to obtain United States Food and Drug Administration, or FDA, approval
of specified PCA3 assays and to file an application with the FDA for regulatory
approval of a PCA3 assay in the United States by a specified date. In addition,
we agreed to make annual payments of $0.5 million to DiagnoCure until specific
milestones are met. After our cumulative net sales of licensed products exceed
$50.0 million, half of the annual payments may be applied against future
royalties due and payable to DiagnoCure under our agreement with DiagnoCure.
In addition, pursuant to the terms of the amendment, in April 2009 we paid
$5.0 million to purchase 4.9 million shares of newly issued DiagnoCure preferred
stock, which is convertible, in whole or in part at our election, into
DiagnoCure common stock.
Credit Agreement
In February 2009, we entered into a credit agreement with Bank of America,
which provided for a one-year senior secured revolving credit facility in an
amount of up to $180.0 million that is subject to a borrowing base formula. The
revolving credit facility has a sub-limit for the issuance of letters of credit
in a face amount of up to $10.0 million. Advances under the revolving credit
facility are intended to be used to consummate our acquisition of Tepnel and for
other general corporate purposes. At our option, loans accrue interest at a per
annum rate based on, either: the base rate (the base rate is defined as the
greatest of (i) the federal funds rate plus a margin equal to 0.50%, (ii) Bank
of America's prime rate and (iii) the London Interbank Offered Rate, or LIBOR,
plus a margin equal to 1.00%); or LIBOR plus a margin equal to 0.60%, in each
case for interest periods of 1, 2, 3 or 6 months as selected by us. In
connection with the credit agreement, we also entered into a security agreement,
pursuant to which we secured our obligations under the credit agreement with a
first priority security interest in the securities, cash and other investment
property held in specified accounts maintained by Merrill Lynch, Pierce, Fenner
& Smith Incorporated, an affiliate of Bank of America.
In March 2009, we borrowed $170.0 million under the revolving credit facility
in anticipation of funding the acquisition of Tepnel. Also in March 2009, we
amended the credit agreement with Bank of America to increase the amount that we
may borrow from time to time under the credit agreement from $180.0 million to
$250.0 million.
In April 2009, we borrowed an additional $70.0 million under the revolving
credit facility with Bank of America and used approximately $137.1 million of
such borrowings (based on the then applicable exchange rate) to fund our
acquisition of Tepnel. As of June 30, 2009, the total principal amount
outstanding under the revolving credit facility was $240.0 million.
In connection with the execution of the credit agreement with Bank of
America, we terminated the commitments under our unsecured bank line of credit
with Wells Fargo Bank, N.A., effective as of February 27, 2009. There were no
amounts outstanding under this line of credit as of the termination date.
Corporate Collaboration with Novartis
In January 2009, we entered into an agreement, referred to herein as
Amendment No. 11, with Novartis to amend the June 11, 1998 collaboration
agreement, or the 1998 Agreement, between the parties. The effective date of
Amendment No. 11 is January 1, 2009. Amendment No. 11 extends to June 30, 2025
the term of our blood screening collaboration with Novartis under the 1998
Agreement. The 1998 Agreement was scheduled to expire by its terms in 2013.
The 1998 Agreement provided that we were solely responsible for manufacturing
costs incurred in connection with the collaboration, while Novartis was
responsible for sales and marketing expenses associated with the collaboration.
Amendment No. 11 provides that, effective January 1, 2009, we will recover 50%
of our cost of product sales incurred in connection with the collaboration,
which is recorded in the form of revenue. In addition, we will receive a
percentage of the blood screening assay revenue generated under the
collaboration, as described below.
The 1998 Agreement provided that we share revenue from the sale of blood
screening assays under the collaboration with Novartis. Under the terms of the
1998 Agreement, as previously amended, our share of revenue from any assay that
included a test for HCV was 45.75%. Amendment No. 11 modifies our share of such
revenues, initially reducing it to 44% in 2009. Our share of blood screening
assay revenue increases in subsequent years as follows: 2010-2011, 46%;
2012-2013, 47%; 2014, 48%; and 2015, 50%. Our share of blood screening assay
revenue is fixed at 50% from January 1, 2015 though the remainder of the amended
term of the agreement. Under Amendment No. 11, our share of blood screening
assay revenue from any assay that does not test for HCV remains at 50%.
Amendment No. 11 also provides that Novartis will reduce the amount of time
between product sales and payment of our share of blood screening assay revenue
from 45 days to 30 days. This reduction in reporting time allowed us to
eliminate one month of the reporting lag for net revenues resulting in an
$8.2 million one-time benefit in the first quarter of 2009.
As part of Amendment No. 11, Novartis has agreed to provide certain funding
to customize our Panther instrument, a fully automated molecular testing
platform now in development, for use in the blood screening market. Novartis has
also agreed to pay us a milestone payment upon the first commercial sale of the
Panther instrument. The parties will equally share any profit attributable to
Novartis' sale or lease of Panther instruments under the collaboration. The
parties have also agreed to evaluate, using our technologies, the development of
companion diagnostics for current or future Novartis medicines. Novartis has
agreed to provide us with certain funding in support of initial research and
development.
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 June 30, 2009, we repurchased and retired approximately 1,602,000
shares under this program at an average price of $43.66, or approximately $70.0
million in total. From its inception through June 30, 2009, we have repurchased
and retired approximately 4,182,000 shares under this program at an average
price of $43.17, or approximately $180.5 million in total.
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; 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 second 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 available-for-sale 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 municipal securities with a current
unrealized loss position to be other-than-temporarily impaired at June 30, 2009
since 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 June 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.
Adoption of recent accounting pronouncements
EITF Issue No. 07-1
Effective January 1, 2009, we adopted Emerging Issues Task Force, or EITF,
Issue No. 07-1, "Accounting for Collaborative Agreements Related to the
Development and Commercialization of Intellectual Property." EITF Issue No. 07-1
defines collaborative agreements as a contractual arrangement in which the
parties are active participants to the arrangement and are exposed to the
significant risks and rewards that are dependent on the ultimate commercial
success of the endeavor. Additionally, it requires that revenue generated and
costs incurred on sales to third parties as it relates to a collaborative
agreement be recognized as gross or net based on EITF Issue No. 99-19,
"Reporting Revenue Gross as a Principal versus Net as an Agent." Essentially,
this requires the party that is identified as the principal participant in a
transaction to record the transaction on a gross basis in its financial
statements. It also requires payments between participants to be accounted for
in accordance with already existing generally accepted accounting principles,
unless none exist, in which case a reasonable, rational, consistent method
should be used. The adoption of this statement did not have an impact on our
consolidated financial statements, as all agreements were in compliance with
this standard prior to its adoption.
SFAS No. 160
Effective January 1, 2009, we adopted Statement of Financial Accounting
Standards, or SFAS, No. 160, "Non-controlling Interests in Consolidated
Financial Statements (an amendment of Accounting Research Bulletin No. 51)."
SFAS No. 160 requires that non-controlling (minority) interests be reported as a
component of equity, that net income attributable to the parent and to the
non-controlling interest be separately identified in the income statement, that
changes in a parent's ownership interest while the parent retains its
controlling interest be accounted for as equity transactions, and that any
retained non-controlling equity investment upon the deconsolidation of a
subsidiary be initially measured at fair value. As of June 30, 2009, we did not
have any consolidated subsidiaries in which we had a non-controlling interest,
and therefore adoption of this statement did not have an impact on our
consolidated financial statements.
SFAS No. 141(R)
Effective January 1, 2009, we adopted SFAS No. 141(R), "Business
Combinations." SFAS No. 141(R) changes the requirements for an acquirer's
recognition and measurement of the assets acquired and liabilities assumed in a
business combination, including the treatment of contingent consideration,
pre-acquisition contingencies, transaction costs, in-process research and
development and restructuring costs. In addition, under SFAS No. 141(R), changes
in an acquired entity's deferred tax assets and uncertain tax positions after
the measurement period will impact income tax expense. See Note 2 - Business
combination, of the Notes to the Consolidated Financial Statements included in
Item 1 of Part I of this report for the impact of the adoption of SFAS
No. 141(R) on our financial results as of June 30, 2009.
Results of Operations
Product Sales
(Dollars in millions) Three Months Ended June 30, Six Months Ended June 30,
2009 2008 $ Change % Change 2009 2008 $ Change % Change
Clinical diagnostics $ 67.8 $ 57.2 $ 10.6 19 % $ 127.4 $ 109.7 $ 17.7 16 %
Blood screening 45.8 56.5 (10.7 ) (19 )% 98.7 105.5 (6.8 ) (6 )%
Research products and
services 3.2 - 3.2 N/M 3.2 - 3.2 N/M
Product Sales $ 116.8 $ 113.7 $ 3.1 3 % $ 229.3 $ 215.2 $ 14.1 7 %
As a percent of total
revenues 97 % 95 % 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 recent
acquisition of Tepnel, which are primarily sold under the LIFEMATCH 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 3% and 7% in the three and six months ended
June 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
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