Endo Pharmaceuticals Reports First Quarter 2009 Financial Results
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CHADDS FORD, Pa., April 29 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals
(Nasdaq: ENDP) today reported financial results for the first quarter of 2009,
including results beginning on February 23, 2009 for Indevus Pharmaceuticals,
which Endo acquired during the quarter.
Net sales during the first quarter of 2009 increased 16% to $335.3 million
compared with $290.3 million in the first quarter of 2008. Net income for the
three months ended March 31, 2009 was $39.0 million compared with $59.5
million in the comparable 2008 period. As detailed in the Supplemental
Financial Information below, adjusted net income for the three months ended
March 31, 2009 was $79.0 million compared with $68.2 million in the same
period in 2008.
Diluted earnings per share for the three months ended March 31, 2009 were
$0.33 compared with $0.44 in the first quarter of 2008. Adjusted diluted
earnings per share for the three months ended March 31, 2009 were $0.67
compared with $0.51 in the same period in 2008.
"We had a solid first quarter during which we diversified our commercial
business beyond pain management, reorganized our sales and marketing and R&D
groups, and repositioned our company for sustainable future growth," said Dave
Holveck, president and chief executive officer of Endo Pharmaceuticals. "I
believe our broader therapeutic focus on urology and oncology and more capable
specialty infrastructure will enable us to meet aggressive long-term growth
targets and adapt quickly to a changing healthcare environment."
Selected Product Review
PAIN PRODUCTS
LIDODERM(R): For the quarter ended March 31, 2009, net sales of LIDODERM
decreased 5% to $171.6 million compared with $180.5 million in the same period
a year ago. Prescription volume for LIDODERM decreased 2% in the first quarter
of 2009 versus the comparable 2008 period.
OPANA(R) ER and OPANA(R): Combined net sales for the OPANA franchise
increased 31% to $52.8 million for the first quarter 2009 compared with $40.3
million in the same period a year ago. Prescription volume for OPANA ER and
OPANA increased 58% in the first quarter 2009 versus the comparable 2008
period.
FROVA(R): Net sales of FROVA were $12.3 million for the three months ended
March 31, 2009 compared with $14.1 million for the same period in 2008.
Voltaren(R) Gel: Net sales of Voltaren Gel were $12.3 million for the three
months ended March 31, 2009. Voltaren Gel was launched in March 2008.
Responding to marketplace demand, Voltaren Gel 3 & 5 Packs became available in
April 2009.
ONCOLOGY/ENDOCRINOLOGY PRODUCTS
For the first quarter of 2009, net sales of other branded products were $10.2
million compared with $1.8 million in the same period in 2008. Included in
other branded products are net sales from products recently obtained through
our acquisition of Indevus Pharmaceuticals, Inc. for the period February 23,
2009 through March 31, 2009. Net Sales of SUPPRELIN(R) LA applicable to Endo
results for the first quarter were $2.7 million. Net Sales of VANTAS(R)
applicable to Endo results for the first quarter were $1.9 million.
GENERIC AND NON-PROMOTED PRODUCTS
For the first quarter of 2009, net sales from the company's generic products
were $42.4 million compared with $21.8 million in the same period in 2008. Net
sales of Percocet(R) were $33.7 million for the three months ended March 31,
2009 compared with $31.8 million in the same period in 2008. During the first
quarter of 2009, the company benefited from a market shortfall in the supply
for certain generic products.
Acquisition of Indevus Pharmaceuticals, Inc.
During the first quarter of 2009, we completed our acquisition of Indevus
Pharmaceuticals, Inc. and acquired 100% of the outstanding shares of Indevus
for a purchase price of $4.50 per share in cash and the non-transferable
contractual right to receive up to an additional $3.00 per share in cash
payable in the future upon achievement of certain regulatory and sales
milestones. The results of operations for Indevus have been included in our
consolidated operating results beginning on February 23, 2009.
Conference Call Information
Endo will conduct a conference call with financial analysts to discuss this
news release today at 10:30 a.m. ET. Investors and other interested parties
may call 866-383-7998 (domestic) or 617-597-5329 (international) and enter
code 54725288. Please dial in 10 minutes prior to the scheduled start time.
A replay of the call will be available from April 29 at 1:30 p.m. ET until
12:00 a.m. ET on May 6 by dialing 888-286-8010 (domestic) or 617-801-6888
(international), pass code 95260431. A simultaneous webcast of the call may
be accessed by visiting www.endo.com. In addition, a replay of the webcast
will be available until 12:00 a.m. ET on May 6. The replay can be accessed by
clicking on "Events" in the Investor Relations section of the website.
Supplemental Financial Information
The following tables provide a reconciliation of our GAAP statements of
operations to our adjusted statements of operations for each of the three
months ended March 31, 2009 and March 31, 2008 (Certain prior period amounts
have been reclassified to conform to the current period presentation) (in
thousands, except per share data):
Three Months Ended March 31, Actual
2009 (unaudited) (GAAP) Adjustments Adjusted
Net sales $335,300 $- $335,300
Costs and expenses:
Cost of sales 83,009 (12,996) (1) 70,013
Selling, general and
administrative 120,006 - 120,006
Research and development 28,414 (9,438) (2) 18,976
Acquisition-related costs 26,405 (26,405) (3) -
Operating income 77,466 48,839 126,305
Interest expense, net 7,593 (3,781) (4) 3,812
Other expense, net 1,105 172 (5) 1,277
Income before income taxes 68,768 52,448 121,216
Income taxes 29,731 12,462 (6) 42,193
Net income $39,037 $39,986 $79,023
Diluted earnings per share $0.33 $0.67
Diluted weighted average
shares 117,209 117,209
Notes to reconciliation of our GAAP statements of operations to our
adjusted statements of operations:
(1) To exclude amortization of commercial intangible assets related to
marketed products ($11,377) and the impact of the Indevus inventory
step-up recorded as part of acquisition accounting ($1,619).
(2) To exclude upfront and milestone payments to partners.
(3) To exclude Indevus transaction and separation costs.
(4) To exclude additional interest expense as a result of adopting APB
14-1
(5) To exclude changes in fair value of financial instruments, net.
(6) To reflect the tax effect of the pre-tax adjustments above at the
applicable tax rates and the cash tax savings resulting from the
Indevus acquisition.
Three Months Ended March 31, Actual
2008 (unaudited) (GAAP) Adjustments Adjusted
Net sales $290,271 $- $290,271
Costs and expenses:
Cost of sales 56,534 (4,189) (1) 52,345
Selling, general and
administrative 115,002 (3,278) (2) 111,724
Research and development 33,582 (6,450) (3) 27,132
Operating income 85,153 13,917 99,070
Interest income, net (9,265) - (9,265)
Other expense, net 282 - 282
Income before income taxes 94,136 13,917 108,053
Income taxes 34,608 5,239 (4) 39,847
Net income $59,528 $8,678 $68,206
Diluted earnings per share $0.44 $0.51
Diluted weighted average
shares 134,652 134,652
Notes to reconciliation of our GAAP statements of operations to our
adjusted statements of operations:
(1) To exclude amortization of commercial intangible assets related to
marketed products.
(2) To exclude separation costs.
(3) To exclude upfront and milestone payments to partners.
(4) To reflect the tax effect of the pre-tax adjustments above at the
applicable tax rates.
For an explanation of Endo's reasons for using non-GAAP measures, see Endo's
Current Report on Form 8-K filed today with the Securities and Exchange
Commission.
Reconciliation of Projected GAAP Diluted Earnings Per Share to
Adjusted Diluted Earnings Per Share Guidance
Year Ended
December 31, 2009
Projected GAAP diluted income per common
share $1.73 to $1.81
Upfront and milestone payments to
partners $0.26 $0.26
Amortization of commercial intangible
assets $0.48 $0.48
Indevus transaction and separation costs $0.23 $0.23
Interest expense adjustment for APB 14-1 $0.12 $0.12
Tax effect of pre-tax adjustments at the
applicable tax rates and certain other
expected cash tax savings as a result
of the Indevus acquisition ($0.23) ($0.23)
Diluted adjusted income per common share
guidance $2.59 to $2.67
The company's guidance is being issued based on certain assumptions
including:
-- Adjusted effective tax rate of approximately 34% in 2009;
-- Weighted average number of common shares outstanding of 117
million shares for the year ended December 31, 2009;
-- The February 23, 2009 acquisition date of Indevus
Pharmaceuticals, Inc.; and
-- Certain of the above amounts are based on preliminary estimates
and there can be no assurance that Endo will achieve these
results.
About Endo
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the
research, development, sale and marketing of branded and generic prescription
pharmaceuticals used to treat and manage pain, overactive bladder, prostate
cancer and the early onset of puberty in children, or central precocious
puberty (CPP). Its products include LIDODERM(R), a topical patch to relieve
the pain of postherpetic neuralgia; Percocet(R) and Percodan(R) tablets for
the relief of moderate-to-moderately severe pain; FROVA(R) tablets for the
acute treatment of migraine attacks with or without aura in adults; OPANA(R)
tablets for the relief of moderate-to-severe acute pain where the use of an
opioid is appropriate; OPANA(R) ER tablets for the relief of
moderate-to-severe pain in patients requiring continuous, around-the-clock
opioid treatment for an extended period of time; and Voltaren(R)Gel, a
nonsteroidal anti-inflammatory drug indicated for the relief of the pain of
osteoarthritis of joints amenable to topical treatment, such as those of the
hands and the knees. Voltaren(R)Gel is owned and licensed by Novartis AG;
SANCTURA(R) and its XR version for treatment of overactive bladder, VANTAS(R)
for the palliative treatment of advanced prostate cancer, and SUPPRELIN(R) LA
for the treatment of early onset puberty in children. The company markets its
branded pharmaceutical products to physicians in pain management, neurology,
surgery, oncology, and primary care. More information, including this and past
press releases of Endo Pharmaceuticals, is available at www.endo.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 regarding, among other
things, the acquisition of Indevus, the company's financial position, results
of operations, market position, product development and business strategy, as
well as estimates of future net sales, future expenses, future net income and
future earnings per share. Statements including words such as "believes,"
"expects," "anticipates," "intends," "estimates," "plan," "will," "may,"
"intend," "guidance" or similar expressions are forward-looking statements.
Because these statements reflect our current views, expectations and beliefs
concerning future events, these forward-looking statements involve risks and
uncertainties. Investors should note that many factors could affect our future
financial results and could cause our actual results to differ materially from
those expressed in forward-looking statements contained in this press release.
These factors include, but are not limited to; the possibility that the
acquisition of Indevus is not complementary to Endo; the inherent uncertainty
of the timing and success of, and expense associated with, research,
development, regulatory approval and commercialization of our products and
pipeline products; competition in our industry, including for branded and
generic products, and in connection with our acquisition of rights to assets,
including intellectual property; government regulation of the pharmaceutical
industry; our dependence on a small number of products and on outside
manufacturers for the manufacture of our products; our dependence on third
parties to supply raw materials and to provide services for certain core
aspects of our business; new regulatory action or lawsuits relating to our use
of controlled substances in many of our core products; our exposure to product
liability claims and product recalls and the possibility that we may not be
able to adequately insure ourselves; our ability to protect our proprietary
technology; our ability to successfully implement our in-licensing and
acquisition strategy; the availability of third-party reimbursement for our
products; the outcome of any pending or future litigation or claims by the
government; our dependence on sales to a limited number of large pharmacy
chains and wholesale drug distributors for a large portion of our total net
sales; a determination by a regulatory agency that we are engaging in
inappropriate sales or marketing activities, including promoting the
"off-label" use of our products; the loss of branded product exclusivity
periods and related intellectual property; and exposure to securities that are
subject to market risk including auction-rate securities the market for which
is currently illiquid; and other risks and uncertainties, including those
detailed from time to time in our periodic reports filed with the Securities
and Exchange Commission, including our current reports on Form 8-K, quarterly
reports on Form 10-Q and annual reports on Form 10-K, particularly the
discussion under the caption "Item 1A, RISK FACTORS" in our annual report on
Form 10-K for the year ended December 31, 2008, which was filed with the
Securities and Exchange Commission on March 2, 2009. The forward-looking
statements in this press release and on the related conference call are
qualified by these risk factors. These are factors that, individually or in
the aggregate, we think could cause our actual results to differ materially
from expected and historical results. We assume no obligation to publicly
update any forward-looking statements, whether as a result of new information,
future developments or otherwise.
(Tables Attached)
The following tables present Endo's unaudited net sales for the three months
ended March 31, 2009 and March 31, 2008:
Endo Pharmaceuticals Holdings Inc.
Net Sales (unaudited)
(in thousands)
Three Months Ended
March 31,
2009 2008
LIDODERM(R) $171,636 $180,524
OPANA(R) ER AND OPANA(R) 52,765 40,283
Percocet(R) 33,690 31,800
FROVA(R) 12,292 14,055
Voltaren(R) Gel 12,319 -
Other Brands * 10,205 1,816
Total Brands $292,907 $268,478
Total Generics $42,393 $21,793
Total Net Sales $335,300 $290,271
*Other Brands includes Indevus results beginning on February 23, 2009.
The following table presents condensed consolidated cash flow data for the
three months ended March 31, 2009 and March 31, 2008:
Endo Pharmaceuticals Holdings Inc.
Condensed Consolidated Cash Flow Data (unaudited)
(in thousands)
Three Months Ended
March 31,
2009 2008
Net cash provided by operating activities $35,031 $75,453
Net cash (used in) provided by investing
activities (423,555) 125,385
Net cash provided by (used in) financing
activities 6,988 (623)
Net (decrease) increase in cash and cash
equivalents $(381,536) $200,215
Cash and cash equivalents, beginning of
period $775,693 $350,325
Cash and cash equivalents, end of period $394,157 $550,540
SOURCE Endo Pharmaceuticals
Investors/Media, Blaine Davis, +1-610-459-7158, or Media, Kevin Wiggins,
+1-610-459-7281, both of Endo Pharmaceuticals
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