Gen-Probe Reports Strong Financial Results for First Quarter 2007, Raises Full-Year Guidance- Company Records EPS of $0.40, New All-Time High and 48% Above Prior Year -
- Quarterly Product Sales Establish New Record of $87.2 Million, Total Revenues Exceed $100 Million for First Time -
- Quarterly Results, One-Time Tax Benefit Lead to Increased EPS Guidance of $1.39 to $1.45 -SAN DIEGO, May 1, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Gen-Probe Incorporated
(Nasdaq: GPRO) today reported strong financial results for the first quarter
of 2007 and raised its full-year guidance for earnings per share (EPS) and
total revenues.
"Gen-Probe posted strong financial results in the first quarter of 2007,
led by continued robust growth in our clinical diagnostics business," said
Henry L. Nordhoff, the Company's chairman, president and chief executive
officer. "We are raising our full-year financial guidance based on our
first-quarter performance and the expected benefits of lower tax expense, and
now forecast that 2007 EPS will grow between 24% and 29% compared to last
year."
In the first quarter of 2007, net income was $21.5 million ($0.40 per
share), compared to $14.2 million ($0.27 per share) in the prior year period,
an increase of 51% (48% per share). Throughout this press release, all per
share amounts are calculated on a fully diluted basis, and all results are
presented on a GAAP basis that reflects the implementation of SFAS No. 123(R).
In the first quarter of 2007, product sales were a record $87.2 million,
compared to $78.5 million in the prior year period, an increase of 11%. Total
revenues for the first quarter of 2007 were a record $101.1 million, compared
to $86.3 million in the prior year period, an increase of 17%.
As expected, Gen-Probe's total revenues and net income in the first
quarter of 2007 benefited from $10.3 million of royalty and license revenue
received from Bayer, representing the second of three payments due in
connection with the 2006 settlement of the Company's patent infringement
litigation.
Detailed Results
Gen-Probe's clinical diagnostics sales in the first quarter of 2007 were
again led by 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 continued to grow strongly, driven by
market share gains on both the 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.
In blood screening, product sales benefited from continued international
expansion, and from higher pricing associated with commercial sales of the
PROCLEIX(R) WNV (West Nile virus) assay in the United States. Gen-Probe's
blood screening sales in the first quarter of 2007 included $2.9 million in
sales of TIGRIS instruments and spare parts to Chiron. As expected, these
instrument sales to Chiron declined compared to the $5.3 million recorded in
the prior year period. Excluding these sales from both the first quarter of
2007 and the prior year period, blood screening sales grew by 11%.
Gen-Probe's blood screening products are marketed worldwide by Chiron, a
business unit of Novartis Vaccines and Diagnostics.
Product sales were, in millions:
Three Months Ended March 31,
2007 2006 Change
Clinical diagnostics $47.6 $40.1 19%
Blood screening $39.6 $38.4 3%
Total product sales $87.2 $78.5 11%
Collaborative research revenues for the first quarter of 2007 were
$2.4 million, compared to $6.9 million in the prior year period, a decrease of
65% that resulted primarily from the reclassification of revenue associated
with investigational use of the PROCLEIX WNV assay. Beginning in the second
half of 2006, the Company began recording in product sales all revenue
associated with this assay, which was approved by the US Food and Drug
Administration (FDA) for use on Gen-Probe's enhanced semi-automated instrument
system (eSAS) in December of 2005.
Royalty and license revenues for the first quarter of 2007 were
$11.5 million, compared to $0.8 million in the prior year period. This
increase resulted primarily from $10.3 million of revenue associated with the
settlement in 2006 of Gen-Probe's patent infringement litigation against
Bayer.
Gross margin on product sales in the first quarter of 2007 was 66.5%,
compared to 66.1% in the prior year period. This increase resulted primarily
from a favorable product sales mix, namely decreased sales of lower-margin
instruments, as described above, and increased revenue from commercial pricing
of the PROCLEIX WNV assay in the United States. These benefits were partially
offset by additional scrap expense compared to the prior year period,
increased amortization of stock-based compensation expense, and lower
production volumes.
Research and development (R&D) expenses in the first quarter of 2007 were
$20.3 million, compared to $19.3 million in the prior year period, an increase
of 5% that resulted primarily from higher overhead costs. R&D expenses are
expected to increase significantly later in 2007 based on the purchase of HPV
oligonucleotides from Roche, post-marketing studies for the PROCLEIX ULTRIO(R)
assay in the United States, and the development programs for food testing,
hospital-acquired infections, and a fully automated instrument system for
low- and mid-volume labs.
Marketing and sales expenses in the first quarter of 2007 were
$9.5 million, compared to $8.9 million in the prior year period, an increase
of 7% that resulted primarily from higher overhead costs and expenses
associated with assessing and developing new markets.
General and administrative (G&A) expenses in the first quarter of 2007
were $11.3 million, compared to $10.7 million in the prior year period, an
increase of 6% that resulted primarily from higher executive recruiting and
relocation expenses.
Gen-Probe continues to have a strong balance sheet. As of March 31, 2007,
the Company had $319.7 million of cash, cash equivalents and short-term
investments, and no debt. In the first quarter of 2007, Gen-Probe generated
net cash of $31.9 million from its operating activities.
Update on Tax Issues
Gen-Probe adopted FIN No. 48, "Accounting for Uncertainty in Income Taxes
-- an interpretation of SFAS No. 109," as of January 1, 2007. FIN No. 48
provides guidance on the accounting and reporting of various tax
contingencies. As a result of adopting FIN No. 48, Gen-Probe reduced its
retained earnings balance by approximately $1.0 million as of January 1, 2007,
reflecting increased tax reserves.
In addition, the Internal Revenue Service completed an audit of the
Company's 2003 and 2004 federal tax returns in April. As a result, Gen-Probe
expects to record a benefit to income tax expense of approximately
$8.7 million ($0.16 of EPS) in the second quarter of 2007. This benefit
results primarily from the release of reserves associated with federal
research tax credits generated from 1999 to 2004.
Updated 2007 Financial Guidance
"Based on our strong performance in the first quarter, as well as the
one-time tax benefit we expect to record in the second quarter, we are raising
our full-year 2007 revenue and EPS guidance," said Herm Rosenman, the
Company's vice president of finance and chief financial officer. "At the same
time, we intend to pursue long-term shareholder value by investing additional
R&D resources into key programs, including the post-marketing studies for the
PROCLEIX ULTRIO assay."
For the full year 2007, Gen-Probe now expects:
* Total revenues of $386 million to $394 million.
* Product gross margins approximating 68% to 69% of product sales.
* R&D expenses approximating 24% to 25% of total revenues. R&D expenses
are expected to total at least $25 million in each of the next three
quarters.
* Marketing and sales expenses approximating 10% of total revenues.
* G&A expenses approximating 11% to 12% of total revenues.
* EPS of between $1.39 and $1.45, based on approximately 54 million fully
diluted shares outstanding for the year and an underlying tax rate of
35% to 36%, excluding the $8.7 million one-time benefit associated with
completion of the IRS audit, which is expected to be recognized in the
second quarter.
Recent Events
* TIGRIS System Approved to Screen Donated Blood for West Nile Virus. On
March 2, Gen-Probe announced that the FDA had approved the Company's
PROCLEIX TIGRIS system, the first fully automated molecular diagnostics
instrument, to screen donated blood, organs and tissues for West Nile
virus using the PROCLEIX WNV Assay.
* Collaboration with 3M for Healthcare-Associated Infections. On
April 30, Gen-Probe and 3M announced that the companies
have formed an exclusive worldwide collaboration to develop and
commercialize rapid, easy-to-use nucleic acid tests to detect dangerous
healthcare-associated infections such as methicillin-resistant
Staphylococcus aureus.
* Promising PCA3 Data. On March 29, Gen-Probe announced that the
Company's research test for the highly specific prostate cancer gene
PCA3 predicted the results of repeat biopsies more accurately than
traditional prostate specific antigen testing in a study of 233 men.
The study was published in the March issue of the peer-reviewed journal
UROLOGY(R) (69: 532-535, 2007). On March 23, the Company announced
similar results from an ongoing multi-center study presented by
independent researchers at the annual meeting of the European
Association of Urology. The Company's PROGENSATM PCA3 assay has been
CE-marked for the European market.
* New VP of Clinical, Regulatory and Quality. On April 30, Christina
Yang, PhD, joined Gen-Probe as vice president, clinical, regulatory and
quality. Dr. Yang joined the Company from Focus Diagnostics, where she
was vice president, quality and regulatory affairs, since 2003. She
reports to Henry L. Nordhoff.
Webcast Conference Call
A live webcast of Gen-Probe's first quarter 2007 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) 397-1432 for domestic callers and
(203) 369-0539 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 24 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 1,000 people. For more
information, go to 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.
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 the heading "Updated 2007 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 2007 growth, revenue, earnings or other
financial targets, (ii) the risk that we may not earn or receive milestone
payments from our collaborators, including Novartis, (iii) the possibility
that the market for the sale of our new products, such as our TIGRIS system,
APTIMA Combo 2 assay, 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 recent industrial collaborations, may not proceed as planned, (v) the risk
that products including our PROCLEIX ULTRIO assay or TIGRIS instrument for
blood screening may not be approved by regulatory authorities or commercially
available in the time frame we anticipate, or at all, (vi) we may not be able
to compete effectively, (vii) we may not be able to maintain our current
corporate collaborations and enter into new corporate collaborations or
customer contracts, (viii) we are dependent on Novartis, Siemens (as assignee
of Bayer) and other third parties for the distribution of some of our
products, (ix) we are dependent 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. The foregoing list sets forth 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.
Contact:
Michael Watts
Sr. director, investor relations and
corporate communications
858-410-8673
Gen-Probe Incorporated
Consolidated Balance Sheets
(In thousands, except share and per share data)
March 31, December 31,
2007 2006
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $67,428 $87,905
Short-term investments 252,240 202,008
Trade accounts receivable, net of
allowance for doubtful accounts of
$620 and $670 at March 31, 2007 and
December 31, 2006, respectively 27,582 25,880
Accounts receivable - other 2,604 1,646
Inventories 51,713 52,056
Deferred income tax - short term 6,905 7,247
Prepaid expenses 13,840 11,362
Other current assets 3,938 2,583
Total current assets 426,250 390,687
Property, plant and equipment, net 133,962 134,614
Capitalized software 17,809 18,437
Goodwill 18,621 18,621
Deferred income tax - long term 2,064 2,064
License, manufacturing access fees and
other assets 60,813 59,416
Total assets $659,519 $623,839
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $12,038 $13,586
Accrued salaries and employee benefits 15,831 16,723
Other accrued expenses 3,142 3,320
Income tax payable 7,325 14,075
Deferred revenue 758 921
Total current liabilities 39,094 48,625
Non-current income tax payable 14,008 --
Deferred income tax 4 --
Deferred revenue 3,500 3,667
Deferred rent 100 128
Deferred compensation plan liabilities 1,480 1,211
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.0001 par value per share,
20,000,000 shares authorized, none
issued and outstanding -- --
Common stock, $.0001 par value per share;
200,000,000 shares authorized, 52,405,312
and 52,233,656 shares issued and outstanding
at March 31, 2007 and December 31, 2006,
respectively 5 5
Additional paid-in capital 344,713 334,184
Accumulated other comprehensive income (loss) 78 (5)
Retained earnings 256,537 236,024
Total stockholders' equity 601,333 570,208
Total liabilities and stockholders' equity $659,519 $623,839
Gen-Probe Incorporated
Consolidated Statements of Income
(In thousands, except per share data)
(Unaudited)
Three Months Ended
March 31,
2007 2006
Revenues:
Product sales $87,152 $78,528
Collaborative research revenue 2,352 6,885
Royalty and license revenue 11,547 843
Total revenues 101,051 86,256
Operating expenses:
Cost of product sales 29,160 26,609
Research and development 20,258 19,326
Marketing and sales 9,536 8,862
General and administrative 11,281 10,658
Total operating expenses 70,235 65,455
Income from operations 30,816 20,801
Total other income, net 2,545 1,757
Income before income tax 33,361 22,558
Income tax expense 11,886 8,330
Net income $21,475 $14,228
Net income per share:
Basic $0.41 $0.28
Diluted $0.40 $0.27
Weighted average shares outstanding:
Basic 52,170 51,248
Diluted 53,634 52,865
Gen-Probe Incorporated
Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Three Months Ended
March 31,
2007 2006
Operating activities:
Net income $21,475 $14,228
Adjustments to reconcile net income to net cash
from operating activities:
Depreciation and amortization 8,273 6,061
Stock-based compensation charges 5,105 5,123
Stock option income tax benefits 58 --
Excess tax benefit from employee stock options (1,284) (4,394)
Gain on disposal of property and equipment -- (21)
Changes in assets and liabilities:
Accounts receivable (2,649) 2,571
Inventories (39) (191)
Prepaid expenses (2,478) 3,246
Other current assets (1,354) (1,320)
Other long term assets (598) --
Accounts payable (1,549) (601)
Accrued salaries and employee benefits (891) 1,715
Other accrued expenses (25) 1,240
Income tax payable 7,815 3,822
Deferred revenue (330) (2,507)
Deferred income tax 106 (188)
Deferred rent (28) (29)
Deferred compensation plan liabilities 269 --
Net cash provided by operating activities 31,876 28,755
Investing activities:
Proceeds from sales and maturities of short-term
investments 15,871 25,935
Purchases of short-term investments (65,863) (36,742)
Purchases of property, plant and equipment (5,894) (17,768)
Capitalization of intangible assets, including
license and manufacturing access fees (1,817) (1,852)
Other assets (352) 17
Net cash used in investing activities (58,055) (30,410)
Financing activities:
Excess tax benefit from employee stock options 1,284 4,394
Proceeds from issuance of common stock 4,402 9,449
Net cash provided by financing activities 5,686 13,843
Effect of exchange rate changes on cash and cash
equivalents 16 74
Net (decrease) increase in cash and cash
equivalents (20,477) 12,262
Cash and cash equivalents at the beginning of
period 87,905 32,328
Cash and cash equivalents at the end of period $67,428 $44,590
SOURCE Gen-Probe Incorporated
Michael Watts, Sr. director, investor relations and corporate communications of
Gen-Probe Incorporated, +1-858-410-8673
http://www.gen-probe.com
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