Forest Laboratories, Inc. : Reports Fiscal Year First Quarter 2013 Earnings Per Share of $0.21
07/17/2012| 08:05am US/Eastern

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Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical
manufacturer and marketer, today announced that reported earnings per
share equaled $0.21 in the first quarter of fiscal 2013. Reported
earnings per share in the first quarter of fiscal 2012 were $0.90 after
a charge of $40.0 million or $0.14 per share net of tax, related to a
new product licensing agreement with Blue Ash Therapeutics, LLC (Blue
Ash) for azimilide, a novel antiarrhythmic agent. Excluding acquisition
related amortization in both periods presented and the Blue Ash charge
in last year's first quarter, non-GAAP EPS in the first fiscal quarter
of 2013 equaled $0.28 as compared with $1.07 in the first quarter of
fiscal 2012.
Net sales for the quarter decreased 31.9% to $751.8 million, from $1.1
billion in the year-ago period. Namenda® (memantine HCl), an NMDA
receptor antagonist for the treatment of moderate and severe Alzheimer's
disease, recorded sales of $368.4 million during the quarter, an
increase of 15.2% from last year's first quarter. Sales of Bystolic®
(nebivolol), a beta-blocker for the treatment of hypertension, were
$107.8 million, an increase of 38.2% over the year-ago period. Sales of
Savella® (milnacipran HCl), a selective serotonin norepinephrine dual
reuptake inhibitor (SNRI) for the management of fibromyalgia, were $26.7
million, an increase of 3.5% from last year's first quarter. The Company
commercially launched two of its newest products, Daliresp® and Viibryd®
in August 2011. Daliresp (roflumilast), a PDE4 enzyme inhibitor for the
treatment to reduce the risk of exacerbations in patients with chronic
obstructive pulmonary disease (COPD) recorded sales of $17.8 million.
Viibryd (vilazodone HCl), an SSRI and a partial agonist at serotonergic
5-HT1A receptors for the treatment of adults with major
depressive disorder (MDD) recorded sales of $37.4 million. Teflaro®
(ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin
antibiotic for the treatment of adults with community-acquired bacterial
pneumonia and with acute bacterial skin and skin structure infections,
recorded sales of $9.4 million. Teflaro was commercially launched in
March 2011. Sales of Lexapro® (escitalopram oxalate), a selective
serotonin reuptake inhibitor (SSRI) for the initial and maintenance
treatment of MDD in adults and adolescents and generalized anxiety
disorder in adults were $110.0 million compared with $585.7 million in
the year-ago period. Patent protection for Lexapro expired on March 14,
2012.
Contract revenue was $65.8 million in the current quarter compared to
$40.6 million last year. Benicar® (olmesartan medoxomil) co-promotion
income totaled $35.4 million, a decrease of $1.3 million compared to
$36.7 million in last year's first quarter. Contract revenue also
included $29.4 million of income in the current quarter from a
distribution agreement with Mylan, Inc. (Mylan) pursuant to which Mylan
is authorized to sell a generic version of Lexapro and the Company
retains a portion of the profits from those sales.
Cost of sales as a percentage of sales was 22.4% compared with 23.0% in
last year's first quarter. Selling, general and administrative expense
for the current quarter was $382.3 million as compared to $358.1 million
in the year-ago quarter. The current level of spending reflects the
resources and activities we believe are required to support our
currently marketed products, particularly our newest products: Teflaro,
Daliresp and Viibryd and the pre-approval commercial costs associated
with aclidinium and linaclotide.
Research and development (R&D) spending for the current quarter was
$195.2 million compared with $194.4 million in last year's first
quarter. Excluding the $40.0 million payment to Blue Ash in last year's
quarter, R&D would have increased by 26.4%. Neither period included
development milestone expenses.
Income tax expense for the quarter was $20.1 million, reflecting a
quarterly effective tax rate of 26.7%.
Reported net income for the quarter ended June 30, 2012 was $55.3
million or $0.21 per share compared to $258.1 million or $0.90 per share
reported for last year's first quarter.
Diluted shares outstanding at June 30, 2012 were approximately
268,972,000 a reduction of approximately 17.4 million shares compared to
the year-ago period primarily due to the Company's accelerated share
repurchase programs.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said:
"We have just completed our first fiscal quarter following the loss of
patent exclusivity for Lexapro. Our earnings guidance for fiscal year
2013 reflects the impact of Lexapro's patent expiry and the operational
strategies to offset this loss which were initiated years ago. We have
deliberately and strategically diversified our product portfolio so that
we would not be dependent on any single product or therapeutic area.
Today, we have nine new products that have recently reached or which we
expect to reach the marketplace and there are more we have in
development and more we are evaluating to replace Lexapro and eventually
Namenda when its patent expires. We are pleased with the performance
this quarter of three of our most recent product launches, Teflaro,
Daliresp and Viibryd, which were introduced last year. It is still early
days for these products but they are performing well in-line with our
expectations. Two of our other promoted products, Bystolic and Savella,
also turned in solid performances during the quarter. It is worth
noting, that for the first time since launch, sales of Bystolic exceeded
$100 million in a calendar quarter, achieving sales of $107.8 million,
representing growth of 38.2% year over year and 11.2% over last quarter.
Collectively, our next generation products, Bystolic, Savella, Teflaro,
Daliresp and Viibryd had sales of $200 million in the quarter,
representing 63% growth in comparison to the comparable prior year
quarter.
We expect to hear from the U.S. Food and Drug Administration (FDA) in
the coming weeks regarding the approval status of aclidinium for the
long-term maintenance treatment of COPD and later this summer we expect
to hear on the approval status of linaclotide for the treatment of
irritable bowel syndrome with constipation (IBS-C) and chronic
constipation (CC). Assuming approval for both products we will have two
new product launches during fiscal 2013.
During the quarter we and our partner Pierre Fabre were pleased to
report positive top-line Phase III clinical trial results for
levomilnacipran for the treatment of major depressive disorder. With the
clinical development program now completed we can move forward with this
New Drug Application (NDA) filing which we expect to submit to the FDA
in the coming months. We are also on track to file the NDA for
cariprazine for the treatment of schizophrenia and acute mania
associated with bipolar 1 disorder, during the fourth calendar quarter
of 2012. Assuming their respective regulatory approvals in calendar
2013, we expect to launch levomilnacipran and cariprazine during fiscal
2014, which would bring us to nine new product launches since the
beginning of calendar 2008.
Early last month we announced an agreement with Nabriva Therapeutics for
the development of Nabriva's novel antibacterial agent, BC-3781 which
belongs to a novel class of antibiotics, the pleuromutilins. We paid
Nabriva an upfront fee of $25 million upon the expiration of the
Hart-Scott waiting period and will fund and conduct certain development
activities for BC-3781 over the next 12 months. During the 12-month
period we have the exclusive right to acquire Nabriva dependent upon
certain contingencies.
Over the last five years, we received six product approvals in seven
different indications. Our track record of new product development
compares favorably to our specialty-pharma peers, as well as many of the
industry's largest companies. We have one of the strongest and most
diverse product portfolios and pipelines in the industry, in large part
due to our strong core competency in our key therapeutic focus areas and
our status as a partner of choice, as evidenced by our numerous repeat
collaborations. I am confident that our corporate strategy is sound and
we are in a great position to succeed well into the future."
Use of Non-GAAP Financial Information
Non-GAAP earnings per share information adjusted to exclude certain
costs, expenses and other specified items as summarized in the table
below. This information is intended to enhance an investor's overall
understanding of the Company's past financial performance and prospects
for the future. This information is not intended to be considered in
isolation or as a substitute for earnings per share prepared in
accordance with GAAP.
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FOREST LABORATORIES, INC. AND SUBSIDIARIES
SUPPLEMENTAL FINANCIAL INFORMATION
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THREE MONTHS
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ENDED JUNE 30
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2012
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2011
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Reported diluted earnings per share:
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$0.21
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$0.90
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Specified items, per share, net of tax:
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Amortization arising from business combinations
and acquisitions of product rights
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0.07
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0.03
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Licensing payment to Blue Ash Therapeutics, LLC
for azimilide
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0.14
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Adjusted Non-GAAP diluted earnings per
share:
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$0.28
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$1.07
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Forest will host a conference call at 10:00 AM EDT today to discuss the
results. The conference call will be webcast live on the Company's
website at www.frx.com
and also on the website 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 August
16, 2012 at both websites and also by dialing (855) 859-2056 (US and
Canada) or +1 404 537-3406 (international), Conference ID: 94325322.
About Forest Laboratories and Its Products
Forest Laboratories' (NYSE: FRX) longstanding global partnerships and
track record developing and marketing pharmaceutical products in the
United States have yielded its well-established central nervous system
and cardiovascular franchises and innovations in anti-infective,
respiratory, gastrointestinal, and pain management medicine. The
Company's pipeline, the most robust in its history, includes product
candidates in all stages of development across a wide range of
therapeutic areas. The Company is headquartered in New York, NY. To
learn more, visit 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 assumes no obligation to update forward-looking statements
contained in this release to reflect new information or future events or
developments.
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FOREST LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
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(In thousands, except per share amounts)
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THREE MONTHS
ENDED JUNE 30
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2012
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2011
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Revenues:
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Net sales
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$
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751,766
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$
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1,104,135
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Contract revenue
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65,835
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40,639
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Interest income and other
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3,526
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7,157
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Net revenues
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821,127
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1,151,931
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Costs and expenses:
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Cost of goods sold
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168,223
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253,797
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Selling, general and administrative
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382,309
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358,077
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Research and development
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195,166
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194,443
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745,698
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806,317
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Income before income tax expense
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75,429
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345,614
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Income tax expense
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20,144
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87,477
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Net income
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$
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55,285
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$
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258,137
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Net income per share:
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Basic
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$0.21
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$0.90
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Diluted
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$0.21
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$0.90
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Weighted average number of shares outstanding:
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Basic
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268,389
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285,801
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Diluted
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268,972
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286,375
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Forest Laboratories, Inc.
Frank J. Murdolo, 1-212-224-6714
Vice
President - Investor Relations
media.relations@frx.com
© Business Wire 2012
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