NEW YORK, Oct. 21 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX), an international pharmaceutical manufacturer and marketer,
today announced that fully diluted earnings per share equaled $0.80 in the
second quarter of fiscal 2009. Reported earnings per share in the September
2007 quarter were $0.71.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Revenues for the quarter increased 8.0% to $992,506,000 from
$918,960,000 in the year-ago period. Revenues were comprised of net sales,
which increased 9.9% to $925,570,000 from $842,337,000 in the prior year.
Sales in the quarter included $583,896,000 for Lexapro(R) (escitalopram
oxalate), our SSRI for the treatment of depression and anxiety in adults,
an increase of 4.4% from last year. Namenda(R), our NMDA receptor
antagonist for the treatment of moderate and severe Alzheimer's disease,
recorded sales of $246,061,000 during the quarter, growth of 27.6% from
last year. The Company's newest product, BystolicTM (nebivilol) a novel
beta-blocker for the treatment of hypertension, which was launched in late
January 2008, had sales of $14,163,000. Also included in revenues was other
income of $66,936,000 which includes contract revenue of $45,369,000 from
Benicar(R) (olmesartan medoxomil) a decline of 8.5% compared to last year.
Per the agreement with Daiichi Sankyo, active co-promotion of the product
ended last quarter and the Company now receives a residual royalty. The
remaining component of other income was principally interest income, which
totaled $19,194,000.
Net income in the current quarter was $244,086,000, an increase of 8.4%
from $225,244,000 in the second quarter of the prior fiscal year. Selling,
general and administrative expense increased 16.3% to $326,261,000 and
includes significant investment spending to support the launch of Bystolic
as well as pre-launch activities for milnacipran. Research and development
spending decreased 14.3% to $146,357,000 compared to the year-ago period.
Last year's quarter included a $70,000,000 licensing charge in connection
with the Ironwood Pharmaceuticals agreement and the current quarter
includes approximately $36,500,000 in milestone development expenses to
partner companies.
Fully diluted shares outstanding at September 30, 2008 were
305,505,000, a reduction of approximately 11 million shares compared to the
year-ago period due mainly to the Company's share repurchase program.
During the just-completed quarter, the Company repurchased approximately
3.5 million shares leaving an additional 5.7 million shares available for
repurchase under the existing program, which has no expiration date.
Six Month Results
Revenues for the six months ended September 30, 2008 increased 6.1% to
$1,959,350,000 from $1,847,234,000 in the prior year.
Net income for the six months ended September 30, 2008 decreased 1.3%
to $487,006,000 from net income of $493,406,000 reported in the six months
of the prior year, principally due to the termination of the Azor(TM)
co-promotion agreement reported in the June 2008 quarter. Reported diluted
earnings per share increased 3.2% to $1.59 in the current year's first six
months as compared to diluted earnings per share of $1.54 in last year's
six months.
Fiscal 2009 Guidance
The Company now expects that fully diluted earnings per share for the
fiscal year ending March 31, 2009, excluding the one-time charge related to
the termination of the AZOR co-promotion agreement in the first quarter,
will be in the range of $3.30 to $3.40. The Company continues to expect to
spend $100 million in development milestones; however, the timing of
certain programs has shifted. The Company also expects to record a more
favorable tax rate for the remainder of the fiscal year as a result of the
retroactive reinstatement of the research tax credit.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said:
"We are very pleased with both the strong financial results reported this
quarter and the continued positive progression of our late-stage pipeline.
The Food and Drug Administration recently advised us that it was not able
to take final action by the scheduled Prescription Drug User Fee Act action
date of October 18, 2008, on our New Drug Application for milnacipran, a
selective serotonin and norepinephrine reuptake inhibitor, for the
management of fibromyalgia. Based on everything we know we still expect
favorable regulatory action in the near future. We are, of course, not able
to predict the FDA's resolution of whatever issues it still regards as
outstanding. While this delay was unexpected, we and our partner Cypress
Bioscience continue to plan for a first calendar quarter 2009 product
launch meeting.
"During the quarter we reported important positive clinical results for
three other late-stage pipeline products; aclidinium, linaclotide and
cariprazine. Regarding aclidinium, we reported positive Phase III ACCLAIM
trial results from two global studies in the treatment of chronic
obstructive pulmonary disease. We plan to meet with the FDA early next year
to discuss the filing of a new drug application based on the ACCLAIM
results. We are also planning additional studies based on modifications of
dose and dosing which we expect will significantly increase the clinical
effectiveness of aclidinium. For linaclotide, we presented at the American
College of Gastroenterology meeting, earlier reported, positive Phase IIb
clinical trial results in the treatment of irritable bowel syndrome with
constipation (IBS-C) and plan to commence, with our partner Ironwood
Pharmaceuticals, two Phase III IBS-C trials by January 2009, following the
initiation of the Phase III clinical program for linaclotide for the
treatment of chronic constipation in September. Lastly, we reported
positive Phase II trial results for cariprazine (RGH-188) in the treatment
of patients with acute mania associated with bipolar I disorder.
"These results demonstrate that we continue to strike the appropriate
balance between delivering a meaningful level of earnings per share,
advancing our exceptionally strong product pipeline and supporting our
currently marketed products, including Bystolic our latest product launch."
Forest will host a conference call at 10:00 AM EDT today to discuss the
results. The conference call will be webcast live beginning at 10:00 AM EDT
on the Company's website at http://www.frx.com and also on the website
http://www.streetevents.com. Please log on to either website at least fifteen
minutes prior to the conference call as it may be necessary to download
software to access the call. A replay of the conference call will be
available until October 31, 2008 at both websites and also by dialing (800)
642-1687 (US or Canada) or +1 706 645-9291 (International). Conference ID:
67369178.
About Forest Laboratories and Its Products
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company
with a long track record of building partnerships and developing and
marketing products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a wide
range of therapeutic areas. The Company is headquartered in New York, NY.
To learn more about Forest Laboratories, visit http://www.FRX.com.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
FOREST LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS SIX MONTHS
ENDED SEPTEMBER 30 ENDED SEPTEMBER 30
(In thousands, except per share amounts)
2008 2007 2008 2007
---- ---- ---- ----
Revenues:
Net sales $925,570 $842,337 $1,819,315 $1,684,953
Contract revenue 47,210 50,313 101,363 103,690
Interest income 19,194 24,932 37,424 51,670
Other income 532 1,378 1,248 6,921
------- ------- --------- ---------
Net revenues 992,506 918,960 1,959,350 1,847,234
------- ------- --------- ---------
Costs and expenses:
Cost of goods sold 205,001 189,992 402,342 376,232
Selling, general
and administrative 326,261 280,439 669,215 541,767
Research and development 146,357 170,738 258,469 307,646
------- ------- --------- ---------
677,619 641,169 1,330,026 1,225,645
------- ------- --------- ---------
Income before income
tax expense 314,887 277,791 629,324 621,589
Income tax expense 70,801 52,547 142,318 128,183
-------- -------- -------- --------
Net income $244,086 $225,244 $487,006 $493,406
======== ======== ======== ========
Net income per share:
Basic $0.80 $0.71 $1.59 $1.55
===== ===== ===== =====
Diluted $0.80 $0.71 $1.59 $1.54
===== ===== ===== =====
Weighted average number of
shares outstanding:
Basic 304,346 315,510 305,687 317,534
======= ======= ======= =======
Diluted 305,505 316,852 306,701 319,375
======= ======= ======= =======
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://www.prnewswire.com/comp/329163.html
CONTACT:
Frank J. Murdolo, Vice President - Investor
Relations, Forest Laboratories, Inc., +1-212-224-6714,
Frank.Murdolo@frx.com
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