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 SIX MONTHS THREE 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
======= ======= ======= =======
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Frank J. Murdolo, Vice President
- Investor Relations, Forest Laboratories, Inc., +1-212-224-6714,
Web Site: http://www.frx.com/ Company News On-Call:
http://www.prnewswire.com/comp/329163.html
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