-- Company Posts Non-GAAP EPS of $0.51(1), Excluding $0.02 of
Expenses Related to Tepnel Acquisition -- SAN DIEGO, April 30
/PRNewswire-FirstCall/ -- Gen-Probe Incorporated (NASDAQ:GPRO)
today reported financial results for the first quarter of 2009,
including non-GAAP earnings per share (EPS) of $0.51. "Gen-Probe
posted good financial results in the first quarter of 2009,
highlighted by a new record in clinical diagnostics product sales,
despite significant foreign exchange headwinds," said Henry L.
Nordhoff, the Company's chairman and chief executive officer. "In
recent weeks, we also completed our Tepnel acquisition and decided
to begin a U.S. clinical trial of our PCA3 prostate cancer test,
both of which we expect to drive future growth." As expected, total
revenues and net income declined in the first quarter of 2009
compared to the prior year period because the Company recorded
$16.4 million of revenue from Bayer in the first quarter of 2008.
This non-recurring revenue, which added $0.20 to EPS in the prior
year period, represented the third and final payment due to
Gen-Probe in connection with the 2006 settlement of the companies'
patent infringement litigation. In the first quarter of 2009,
product sales were $112.5 million, compared to $101.5 million in
the prior year period, an increase of 11%. Compared to the first
quarter of 2008, the stronger U.S. dollar reduced product sales
growth by an estimated 4%. Total revenues for the first quarter of
2009 were $116.2 million, compared to $122.6 million in the prior
year period, a decrease of 5%. Net income was $27.0 million ($0.51
per share) on a non-GAAP basis in the first quarter of 2009,
compared to $31.9 million ($0.58 per share) on a GAAP basis in the
prior year period, a decrease of 15% (12% per share). Gen-Probe's
non-GAAP results for the first quarter of 2009 exclude $1.6 million
($0.02 per share) of expenses related to the Company's acquisition
of Tepnel. Including these expenses, and on a GAAP basis, net
income in the first quarter of 2009 was $25.7 million ($0.48 per
share). Detailed Results Gen-Probe's clinical diagnostics sales in
the first quarter of 2009 benefited from continued growth of the
APTIMA Combo 2(R) assay, an amplified nucleic acid test (NAT) for
simultaneously detecting Chlamydia trachomatis (CT) and Neisseria
gonorrhoeae (GC). Sales of this assay increased based on market
share gains on both the Company's semi-automated instrument
platform and on the high-throughput, fully automated TIGRIS(R)
system. Revenue from the PACE(R) product line, the Company's
non-amplified tests for the same microorganisms, declined in the
first quarter compared to the prior year period, in line with
Gen-Probe's expectations. Clinical diagnostics sales also were
negatively affected by the stronger U.S. dollar, which reduced
growth by an estimated 2% compared to the prior year period. In
blood screening, product sales in the first quarter of 2009
benefited from $8.2 million of one-time revenue associated with the
previously announced renegotiation of the Company's collaboration
agreement with Novartis Vaccines and Diagnostics. Novartis markets
the collaboration's blood screening products worldwide. This
benefit was largely offset, however, by the stronger U.S. dollar,
which reduced growth by an estimated $2.9 million, or 6%; by $3.9
million of reduced instrument sales to Novartis due to the timing
of orders; and by $1.3 million of lower West Nile virus assay
shipments due to ordering patterns. Product sales were, in
millions: Three Months Ended March 31, Change 2009 2008 Reported
Constant Currency Clinical diagnostics $59.6 $52.5 14% 16% Blood
screening $52.9 $49.0 8% 14% Total product sales $112.5 $101.5 11%
15% Collaborative research revenues for the first quarter of 2009
were $1.7 million, compared to $2.5 million in the prior year
period, a decrease of 32% that resulted primarily from two factors:
lower reimbursement from Novartis of shared development expenses in
the companies' blood screening collaboration; and the absence of
reimbursement from 3M resulting from the termination of the
companies' collaboration regarding healthcare-associated
infections. Royalty and license revenues for the first quarter of
2009 were $2.0 million, compared to $18.6 million in the prior year
period. As discussed, this significant decrease resulted primarily
from $16.4 million of revenue from Bayer that was recorded in the
prior year period. This revenue represented the third and final
payment due in connection with the 2006 settlement of the
companies' patent infringement litigation. Gross margin on product
sales in the first quarter of 2009 was 70.4%, compared to 67.8% in
the prior year period. This improvement resulted primarily from the
renegotiated blood screening agreement with Novartis, increased
sales of APTIMA(R) assays, and lower instrument sales. These
benefits were offset in part by the stronger U.S. dollar and by
unfavorable manufacturing variances. Research and development
(R&D) expenses in the first quarter of 2009 were $25.0 million,
compared to $23.1 million in the prior year period, an increase of
8%. This increase resulted primarily from costs associated with
U.S. clinical trials of the investigational APTIMA(R) human
papillomavirus (HPV) assay and the development of a fully automated
instrument system for low- and mid-volume labs, known as PANTHER.
Marketing and sales expenses in the first quarter of 2009 were
$11.1 million, compared to $11.9 million in the prior year period,
a decrease of 7% that resulted primarily from the timing of
specific studies associated with the Company's ongoing European
market development efforts for the APTIMA Combo 2, APTIMA HPV and
PROGENSA(TM) PCA3 assays. General and administrative (G&A)
expenses in the first quarter of 2009 were $13.8 million, compared
to $11.9 million in the prior year period, an increase of 16% that
resulted primarily from $1.6 million of expenses associated with
the acquisition of Tepnel. As described above, these
transaction-related costs have been excluded from the Company's
non-GAAP results for the first quarter. Gen-Probe expects to record
additional Tepnel-related charges in the second quarter, which also
will be excluded from the Company's non-GAAP results. Total other
income in the first quarter of 2009 was $4.6 million, compared to
$5.7 million in the prior year period, a decrease of 19% that
resulted primarily from the $1.6 million gain recorded in the first
quarter of 2008 related to the Company's sale of its equity
investment in Molecular Profiling Institute. Gen-Probe continues to
have a strong balance sheet. As of March 31, 2009, the Company had
$652.6 million of cash, cash equivalents and marketable securities,
and $170.0 million outstanding under a revolving credit facility.
The Company currently pays interest on funds borrowed under the
credit facility at a floating rate 0.6 percent above the one-month
London Interbank Offered Rate (LIBOR), which was recently 0.5
percent. In the first quarter of 2009, Gen-Probe generated net cash
of $52.0 million from its operating activities, more than double
the Company's net income. The Company also repurchased
approximately 0.9 million shares of its common stock for $35.6
million during the quarter. Updated 2009 Financial Guidance "We are
updating our guidance based on our solid first-quarter performance
and our Tepnel acquisition," said Herm Rosenman, the Company's
senior vice president of finance and chief financial officer. "We
continue to expect solid growth from our STD franchise, new
products and recently acquired business, although we anticipate
that blood screening growth will be pressured by the strong dollar
and increasing competitive pressures." In the table below,
Gen-Probe's non-GAAP guidance excludes certain expenses related to
the Tepnel acquisition, namely transaction costs and the increase
in non-cash depreciation and amortization expense required under
the rules of purchase accounting. These expenses are forecast to
total between $8 million and $10 million in 2009, equating to
between ($0.10) and ($0.13) of EPS on a GAAP basis. Current Current
Guidance Previous Guidance (GAAP) Guidance (non-GAAP) (GAAP)* Total
revenues $490 to $510 $490 to $510 $460 to $490 million million
million Product gross margins 68% to 70% 68% to 70% 69% to 72%
R&D expenses 21% to 23% 21% to 23% 20% to 22% Marketing and
sales expenses 10% to 11% 11% to 12% 10% to 11% G&A expenses
10% to 11% 11% to 12% 10% to 11% Tax rate 33% to 34% 33% to 34% 34%
Diluted shares outstanding 52 million 52 million 52 to 54 million
EPS $1.85 to $2.00 $1.72 to $1.90 $1.80 to $2.05 * Did not include
revenues or expenses associated with the acquisition of Tepnel.
Recent Events -- Carl Hull Elected CEO. On March 23, Gen-Probe
announced that its board of directors had elected Carl W. Hull the
Company's new chief executive officer (CEO), effective May 18,
2009. Mr. Hull, currently the Company's president and chief
operating officer, will become CEO following the retirement of
current CEO Henry L. Nordhoff. Mr. Hull also is expected to join
the Company's board of directors at that time. -- Tepnel
Acquisition Completed. On April 8, Gen-Probe announced that the
Company had completed its acquisition of Tepnel Life Sciences plc,
a rapidly growing molecular diagnostics and pharmaceutical services
company based in the United Kingdom. The acquisition brings
Gen-Probe new growth opportunities in transplant diagnostics,
genetic testing and pharmaceutical services, and accelerates the
Company's European expansion strategy. -- New Credit Facility. On
March 2, Gen-Probe announced it was borrowing $170.0 million under
a newly issued credit facility to finance its pending acquisition
of Tepnel and for other general corporate purposes, including its
existing share repurchase program. The maximum amount that may be
borrowed under the facility was increased in April to $250.0
million, under which the Company has borrowed $240.0 million. --
U.S. Clinical Trial for PCA3. On April 29, Gen-Probe announced that
it intends to initiate a U.S. clinical trial for its
investigational PCA3 assay. The trial is expected to begin in the
third quarter of 2009 and take approximately a year to complete.
The Company also announced that it had amended its PCA3 license
agreement with DiagnoCure, and will acquire $5 million of newly
issued DiagnoCure convertible preferred stock. -- Victory in HPV
Arbitration. On April 1, Gen-Probe announced that the Company,
along with its co-respondents F. Hoffmann-La Roche Ltd. and Roche
Molecular Systems, Inc., had prevailed in its arbitration with
Digene (now Qiagen) concerning the Company's supply and purchase
agreement with Roche for HPV products. Webcast Conference Call A
live webcast of Gen-Probe's first quarter 2009 conference call for
investors can be accessed at http://www.gen-probe.com/ beginning at
4:30 p.m. Eastern Time today. The webcast will be archived for at
least 90 days. A telephone replay of the call also will be
available for approximately 24 hours. The replay number is
866-454-1437 for domestic callers and 203-369-1239 for
international callers. About Gen-Probe Gen-Probe Incorporated is a
global leader in the development, manufacture and marketing of
rapid, accurate and cost-effective nucleic acid tests (NATs) that
are used primarily to diagnose human diseases and screen donated
human blood. Gen-Probe has more than 25 years of NAT expertise, and
received the 2004 National Medal of Technology, America's highest
honor for technological innovation, for developing NAT assays for
blood screening. Gen-Probe is headquartered in San Diego and
employs approximately 1,200 people. For more information, go to
http://www.gen-probe.com/. Trademarks APTIMA, APTIMA COMBO 2, PACE,
PROGENSA and TIGRIS are trademarks of Gen-Probe Incorporated.
ULTRIO and PROCLEIX are trademarks of Chiron, a business unit of
Novartis Vaccines and Diagnostics. All other trademarks are the
property of their owners. About Non-GAAP Financial Measures To
supplement Gen-Probe's financial results for the first quarter of
2009 and its updated 2009 financial guidance, in each case
presented in accordance with GAAP, Gen-Probe uses the following
financial measures defined as non-GAAP by the SEC: non-GAAP net
income, non-GAAP G&A expenses, non-GAAP effective income tax
rate, and non-GAAP EPS. Gen-Probe's management does not itself, nor
does it suggest that investors should, consider such non-GAAP
financial measures in isolation from, or as a substitute for,
financial information prepared and presented in accordance with
GAAP. Gen-Probe's management believes that these non-GAAP financial
measures provide meaningful supplemental information regarding the
Company's performance by excluding certain expenses that may not be
indicative of core business results. Gen-Probe believes that both
management and investors benefit from referring to these non-GAAP
financial measures in assessing Gen-Probe's performance and when
planning, forecasting and analyzing future periods. These non-GAAP
financial measures also facilitate management's internal
comparisons to Gen-Probe's historical performance and our
competitors' operating results. Gen-Probe believes these non-GAAP
financial measures are useful to investors in allowing for greater
transparency with respect to supplemental information used by
management in its financial and operational decision making.
Caution Regarding Forward-Looking Statements Any statements in this
press release about our expectations, beliefs, plans, objectives,
assumptions or future events or performance, including those under
"Updated 2009 Financial Guidance," are not historical facts and are
forward-looking statements. These statements are often, but not
always, made through the use of words or phrases such as believe,
will, expect, anticipate, estimate, intend, plan and would. For
example, statements concerning Gen-Probe's financial condition,
possible or expected results of operations, regulatory approvals,
future milestone payments, growth opportunities, and plans and
objectives of management are all forward-looking statements.
Forward-looking statements are not guarantees of performance. They
involve known and unknown risks, uncertainties and assumptions that
may cause actual results, levels of activity, performance or
achievements to differ materially from those expressed or implied.
Some of these risks, uncertainties and assumptions include but are
not limited to: (i) the risk that we may not achieve our expected
2009 financial targets, (ii) the risk that we may not integrate
acquisitions such as Tepnel successfully, (iii) the possibility
that the market for the sale of our new products, such as our
TIGRIS system, PROCLEIX ULTRIO assay and PROGENSA PCA3 assay, may
not develop as expected, (iv) the enhancement of existing products
and the development of new products, including products, if any, to
be developed under our industrial collaborations, may not proceed
as planned, (v) the risk that products, including the
investigational PROGENSA PCA3 assay for which we expect to begin
clinical trials shortly, may not be approved by regulatory
authorities or commercially available in the time frame we
anticipate, or at all, (vi) the risk that we may not be able to
compete effectively, (vii) the risk that we may not be able to
maintain our current corporate collaborations and enter into new
corporate collaborations or customer contracts, (viii) our
dependence on Novartis, Siemens (as assignee of Bayer) and other
third parties for the distribution of some of our products, (ix)
our dependence on a small number of customers, contract
manufacturers and single source suppliers of raw materials, (x)
changes in third-party reimbursement policies regarding our
products could adversely affect sales of our products, (xi) changes
in government regulation affecting our diagnostic products could
harm our sales and increase our development costs, (xii) the risk
that our intellectual property may be infringed by third parties or
invalidated, and (xiii) our involvement in patent and other
intellectual property and commercial litigation could be expensive
and could divert management's attention. This list includes some,
but not all, of the factors that could affect our ability to
achieve results described in any forward-looking statements. For
additional information about risks and uncertainties we face and a
discussion of our financial statements and footnotes, see documents
we file with the SEC, including our most recent annual report on
Form 10-K and all subsequent periodic reports. We assume no
obligation and expressly disclaim any duty to update
forward-looking statements to reflect events or circumstances after
the date of this news release or to reflect the occurrence of
subsequent events. Gen-Probe Incorporated Consolidated Balance
Sheets (In thousands, except share and per share data) March 31,
December 31, 2009 2008 (unaudited) Assets Current assets: Cash and
cash equivalents $286,195 $60,122 Marketable securities 366,395
445,056 Trade accounts receivable, net of allowance for doubtful
accounts of $600 and $700 at March 31, 2009 and December 31, 2008,
respectively 35,206 33,397 Accounts receivable - other 1,886 2,900
Inventories 52,175 54,406 Deferred income tax - short term 5,965
7,269 Prepaid income tax - 2,306 Prepaid expenses 14,144 15,094
Other current assets 5,699 6,135 Total current assets 767,665
626,685 Marketable securities 32,677 - Property, plant and
equipment, net 142,799 141,922 Capitalized software, net 12,780
13,409 Goodwill 18,621 18,621 Deferred income tax - long term
12,286 12,286 Licenses, manufacturing access fees and other assets,
net 56,483 56,608 Total assets $1,043,311 $869,531 Liabilities and
stockholders' equity Current liabilities: Accounts payable $15,788
$16,050 Accrued salaries and employee benefits 19,434 25,093 Other
accrued expenses 6,239 4,027 Income tax payable 8,491 - Short-term
borrowings 170,000 - Deferred revenue - short term 1,592 1,278
Total current liabilities 221,544 46,448 Non-current income tax
payable 4,671 4,773 Deferred income tax - long term 54 55 Deferred
revenue - long term 2,167 2,333 Deferred compensation plan
liabilities 2,244 2,162 Commitments and contingencies Stockholders'
equity: Preferred stock, $0.0001 par value per share, 20,000,000
shares authorized, none issued and outstanding - - Common stock,
$0.0001 par value per share; 200,000,000 shares authorized,
52,068,633 and 52,920,971 shares issued and outstanding at March
31, 2009 and December 31, 2008, respectively 5 5 Additional paid-in
capital 353,304 382,544 Accumulated other comprehensive income
5,419 3,055 Retained earnings 453,903 428,156 Total stockholders'
equity 812,631 813,760 Total liabilities and stockholders' equity
$1,043,311 $869,531 Gen-Probe Incorporated Consolidated Statements
of Income - GAAP (In thousands, except per share data) (Unaudited)
Three Months Ended March 31, 2009 2008 Revenues: Product sales
$112,522 $101,507 Collaborative research revenue 1,675 2,459
Royalty and license revenue 1,986 18,597 Total revenues 116,183
122,563 Operating expenses: Cost of product sales 33,314 32,636
Research and development 24,998 23,066 Marketing and sales 11,055
11,908 General and administrative 13,846 11,937 Total operating
expenses 83,213 79,547 Income from operations: 32,970 43,016 Other
income/(expense) Interest income 4,882 4,207 Interest expense (151)
- Other income/(expense) (142) 1,473 Total other income, net 4,589
5,680 Income before income tax 37,559 48,696 Income tax expense
11,812 16,751 Net income $25,747 $31,945 Net income per share:
Basic $0.49 $0.59 Diluted $0.48 $0.58 Weighted average shares
outstanding: Basic 52,407 53,796 Diluted 53,126 55,023 Gen-Probe
Incorporated Consolidated Statements of Income (In thousands,
except per share data) (Unaudited) Three Months Ended Three Months
Ended March 31, 2009 March 31, 2008 Non- Adjustments GAAP Non-
Adjustments GAAP GAAP GAAP Revenues: Product sales $112,522 $ -
$112,522 $101,507 $- $101,507 Collaborative research revenue 1,675
- 1,675 2,459 - 2,459 Royalty and license revenue 1,986 - 1,986
18,597 - 18,597 Total revenues 116,183 - 116,183 122,563 - 122,563
Operating expenses: Cost of product sales 33,314 - 33,314 32,636 -
32,636 Research and development 24,998 - 24,998 23,066 - 23,066
Marketing and sales 11,055 - 11,055 11,908 - 11,908 General and
administrative 12,244 1,602 13,846 11,937 - 11,937 Total operating
expenses 81,611 1,602 83,213 79,547 - 79,547 Income from operations
34,572 (1,602) 32,970 43,016 - 43,016 Other income/ (expense)
Interest income 4,882 - 4,882 4,207 - 4,207 Interest expense (151)
- (151) - - - Other income/ (expense) (142) - (142) 1,473 - 1,473
Total other income, net 4,589 - 4,589 5,680 - 5,680 Income before
income tax 39,161 (1,602) 37,559 48,696 - 48,696 Income tax expense
12,187 (375) 11,812 16,751 - 16,751 Net income $ 26,974 $ (1,227) $
25,747 $31,945 $- $ 31,945 Net income per share: Basic $ 0.51 $
(0.02) $ 0.49 $ 0.59 $- $ 0.59 Diluted $ 0.51 $ (0.02) $ 0.48 $
0.58 $- $ 0.58 Weighted average shares outstanding: Basic 52,407
52,407 52,407 53,796 - 53,796 Diluted 53,126 53,126 53,126 55,023 -
55,023 Gen-Probe Incorporated Consolidated Statements of Income -
Non-GAAP (In thousands, except per share data) (Unaudited) Three
Months Ended March 31, 2009 2008 Revenues: Product sales $112,522
$101,507 Collaborative research revenue 1,675 2,459 Royalty and
license revenue 1,986 18,597 Total revenues 116,183 122,563
Operating expenses: Cost of product sales 33,314 32,636 Research
and development 24,998 23,066 Marketing and sales 11,055 11,908
General and administrative 12,244 11,937 Total operating expenses
81,611 79,547 Income from operations 34,572 43,016 Other
income/(expense) Interest income 4,882 4,207 Interest expense (151)
- Other income/(expense) (142) 1,473 Total other income, net 4,589
5,680 Income before income tax 39,161 48,696 Income tax expense
12,187 16,751 Net income $ 26,974 $ 31,945 Net income per share:
Basic $ 0.51 $0.59 Diluted $ 0.51 $0.58 Weighted average shares
outstanding: Basic 52,407 53,796 Diluted 53,126 55,023 Gen-Probe
Incorporated Consolidated Statements of Cash Flows (In thousands)
(Unaudited) Three Months Ended March 31, 2009 2008 Operating
activities: Net income $25,747 $31,945 Adjustments to reconcile net
income to net cash provided by operating activities: Depreciation
and amortization 8,748 8,608 Amortization of premiums on
investments, net of accretion of discounts 1,523 1,735 Stock-based
compensation charges 5,758 5,192 Stock-based compensation income
tax benefits 126 369 Excess tax benefit from stock-based
compensation (127) (145) Gain on sale of investment in Molecular
Profiling Institute, Inc. - (1,600) Changes in assets and
liabilities: Trade and other accounts receivable (784) 3,842
Inventories 2,223 (1,796) Prepaid expenses 945 3,447 Other current
assets 436 (1,161) Other long term assets (1,161) (743) Accounts
payable (219) 3,181 Accrued salaries and employee benefits (5,657)
(3,069) Other accrued expenses 2,217 965 Income tax payable 10,709
15,663 Deferred revenue 147 (45) Deferred income tax 1,305 688
Deferred rent - (10) Deferred compensation plan liabilities 82 454
Net cash provided by operating activities 52,018 67,520 Investing
activities: Proceeds from sales and maturities of marketable
securities 84,008 97,290 Purchases of marketable securities
(37,124) (181,546) Purchases of property, plant and equipment
(7,525) (20,033) Purchases of intangible assets, including licenses
and manufacturing access fees (205) (194) Proceeds from sale of
investment in Molecular Profiling Institute, Inc. - 4,100 Other
assets (13) 75 Net cash provided by (used in) investing activities
39,141 (100,308) Financing activities: Excess tax benefit from
stock-based compensation 127 145 Repurchase and retirement of
restricted stock for payment of taxes (34) (41) Repurchases of
common stock (35,627) - Proceeds from issuance of common stock 534
3,027 Borrowings under credit facility 170,000 - Net cash provided
by financing activities 135,000 3,131 Effect of exchange rate
changes on cash and cash equivalents (86) (7) Net increase
(decrease) in cash and cash equivalents 226,073 (29,664) Cash and
cash equivalents at the beginning of period 60,122 75,963 Cash and
cash equivalents at the end of period $286,195 $46,299 Michael
Watts Vice president, investor relations and corporate
communications 858-410-8673 (1) In this press release, all per
share amounts are calculated on a fully diluted basis. Non-GAAP EPS
excludes $1.6 million ($0.02) of expenses related to the Company's
acquisition of Tepnel. Some totals may not foot due to rounding.
(2) In this press release, "constant currency" revenue growth rates
assume that average foreign exchange rates in the first quarter of
2009 were equal to those in the first quarter of 2008. DATASOURCE:
Gen-Probe Incorporated CONTACT: Michael Watts, Vice president,
investor relations and corporate communications, Gen-Probe
Incorporated, +1-858-410-8673 Web Site: http://www.gen-probe.com/
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