ALLERGAN REPORTS FIRST QTR. 8.8% INCREASE IN WORLDWIDE
SALES.
Allergan, Inc. (NYSE:AGN), Irvine, Calif., has announced worldwide
sales increased by 8.8 percent or $33.0 million over the first quarter
last year, at constant currency rates. Including the effects of
currency, worldwide sales for the quarter ended March 30, 2001 were
$396.1 million, an increase of 5.3 percent over $376.2 million reported
in last year's first quarter.
Allergan reported diluted earnings per share of $0.39 and $0.33 for
the first quarters of 2001 and 2000, respectively. Excluding a
non-recurring loss from the cumulative effect of a change in accounting
principle (adoption of SFAS No. 133 discussed later in this document),
an unrealized gain on derivative instruments and a non-recurring
investment gain, Allergan's diluted earnings per share for the
first quarter of 2001, increased 15.6 percent to $0.37 compared with
$0.32 for last year's first quarter.
"It's been a blockbuster period for product approvals for
Allergan. The recent approvals for Lumigan(TM) and Alphagan(R) P by the
U.S. Food and Drug Administration (FDA), BOTOX Cosmetic(TM) by the
Canadian Health Authorities and Sensar(TM) by the Ministry of Health and
Welfare in Japan are the result of our aggressive investment in
Allergan's research and development pipeline. Additionally, in the
consumer eye care business, Allergan received approval for Consept
OneStep(R) in Japan and the new no rub claim for Complete(R) in the U.S.
and Europe. This focus on technology, along with our full commitment
toward the successful launch of these new products, places Allergan at
the beginning of a new cycle of growth," said David E.I. Pyott,
President and Chief Executive Officer. "The continuous creation and
development of new proprietary technology is essential to the ongoing
success of any pharmaceutical company. Allergan is absolutely committed
to dynamic innovation, the fulfillment of unmet medical needs, and the
creation of further stockholder value," Pyott added.
Specialty Pharmaceutical Performance
Eye Care Pharmaceutical Product Line
At constant currency rates, first quarter worldwide eye care
pharmaceutical sales increased 7.5 percent or $13.5 million compared
with the first quarter of 2000. Including the effects of currency, first
quarter 2001 worldwide eye care pharmaceutical sales amounted to $188.0
million, a 5.0 percent increase over last year's $179.1 million.
Year-over-year comparisons are difficult since the first quarter of 2000
was exceptionally strong due to Y2K-related restocking of pharmaceutical
products. Anticipating increased inventory build from Y2K concerns, the
company held distributors' inventories down in the fourth quarter
of 1999.
For the first quarter of 2001, worldwide net product sales of
Alphagan(R) (Brimonidine Tartrate Ophthalmic Solution 0.2%), indicated
for lowering intraocular pressure (IOP) in patients with ocular
hypertension or primary open angle glaucoma, were $66.5 million, a 5.1
percent increase over the same period last year, or a 6.5 percent
increase at constant currency.
During the first quarter of 2001, Allergan received U.S. FDA
approval for both Lumigan(TM) (Bimatoprost Ophthalmic Solution 0.03%)
and Alphagan(R) P (Brimonidine Tartrate Ophthalmic Solution 0.15%)
preserved with Purite(R). Lumigan(TM) is indicated for the reduction of
elevated intraocular pressure (IOP) in patients with open-angle glaucoma
or ocular hypertension who are intolerant of other IOP-lowering
medications or insufficiently responsive to another IOP- lowering
medication. Alphagan(R) P is a topical treatment for elevated
intraocular pressure in patients with glaucoma or ocular hypertension.
Lumigan(TM) was officially launched the second week of April.
Alphagan(R) P is expected to be available in the next six months.
Additionally in the quarter, Allergan licensed the right to develop
and commercialize ATX-S10, an early stage compound used for photodynamic
therapy to treat age-related macular degeneration from Photochemical
Co., Ltd. of Japan.
Skin Care Product Line
Sales for Allergan skin care products were $18.0 million for the
quarter ended March 30, 2001, an increase of 14.6 percent from the $15.7
million reported in the first quarter of last year.
Worldwide net sales for Tazorac(R) and Zorac(R) brands (Tazarotene
Gel 0.05% and 0.10%), indicated for the treatment of acne and psoriasis,
were $8.4 million in the first quarter of 2001, a 21.7 percent increase
over the same period last year. Tazorac(R) total prescription and new
prescription growth in the U.S. increased over the first quarter of last
year by 66.7 percent and 74.3 percent, respectively.
BOTOX(R)/Neurotoxin Product Line
At constant currency rates, BOTOX(R) (Botulinum Toxin Type A)
Purified Neurotoxin Complex net sales increased by 33.5 percent over the
first quarter of 2000. Including the effects of currency, sales for
BOTOX(R) were $67.6 million during the first quarter of 2001, up 30.0
percent over the $52.0 million reported in last year's first
quarter.
During the quarter, the company received regulatory approval from
Canadian Health Authorities (Therapeutic Products Programme) for BOTOX
Cosmetic(TM) for the treatment of glabellar lines (brow furrow)
associated with corrugator and/or procerus muscle activity. This
represents Allergan's first cosmetic approval based on its Phase 3
clinical program. Also in the first quarter, the company submitted a
Supplemental Biologics License Application (SBLA) with the U.S. FDA and
a variation to its Marketing Authorization license in France for
BOTOX(R) in the treatment of glabellar lines. France will serve as the
Reference Member State during the process of including this indication
in our label in Europe under the Mutual Recognition Procedure.
Ophthalmic Surgical and OTC Performance
Ophthalmic Surgical Product Line
At constant currency rates, ophthalmic surgical sales for the first
quarter of 2001 increased 5.7 percent compared to the prior-year first
quarter. Including the effects of currency, sales for the ophthalmic
surgical business were $56.7 million during the first quarter of 2001,
compared with sales of $56.5 million reported in the same period last
year. Slower surgical growth was primarily caused by conditions in the
U.S. business. The slowdown in the U.S. economy appears to have
negatively impacted both the capital equipment market, including
phacoemulsification machines, and the number of elective cataract
surgery procedures.
Following the end of the quarter, Sensar(TM), Allergan's
foldable acrylic intraocular lens indicated for the treatment of
cataracts, was approved by the Ministry of Health and Welfare in Japan.
Additionally, Allergan has expanded its multi-year distribution
agreement with SIS AG Surgical Instrument Systems of Biel Switzerland to
include worldwide rights to commercialize the Amadeus(TM) microkeratome
used in refractive surgery.
Contact Lens Care Product Line
At constant currency rates, contact lens care sales for the first
quarter of 2001 decreased 4.7 percent compared with the first quarter of
2000. Including the effects of currency, sales for the contact lens care
business were $65.8 million for the quarter ended March 30, 2001, a
decrease of 9.7 percent over last year's first quarter sales of
$72.9 million. While the company continued to see sales decline in its
hydrogen peroxide-based contact lens care systems, worldwide net product
sales for Complete(R) Multi-Purpose Solution, indicated for soft contact
lens care, amounted to $31.6 million, a 26.4 percent increase over the
same period last year, or a considerable 32.8 percent increase at
constant currency, in the first quarter of 2001.
During the quarter, Complete(R) Multi-Purpose Solution was approved
in the U.S. and Europe for cleaning frequent-replacement (30 days or
less) soft contact lenses without having to rub them. Extensive tests,
meeting FDA requirements, confirmed that daily use of Complete(R) cleans
lenses without rubbing so that this step can be eliminated for many
wearers. Additionally, a new modern-looking Complete(R)
"rocket" bottle, with its sleek styling and snap-on storage
area for the lens case was introduced to the market in the first quarter
of 2001. Following the end of the quarter, the regulatory authorities
approved Consept OneStep(R) contact lens care system in Japan.
Additional Financial Highlights
For the quarter ended March 30, 2001, gross profit was $296.8
million or 74.9 percent of net sales, representing a 2.4 percentage
point increase over last year's first quarter percentage. The gross
profit percentage increased as a result of shifts in the mix of products
sold to higher margin products including BOTOX(R) and eye care
pharmaceuticals, and gross margin improvements in most of
Allergan's product lines.
Selling, general & administrative (SG&A) expense as a ratio
to net sales was 47.6 percent for the first quarter of 2001, compared to
43.8 percent for the same period last year. The increase of $24.0
million in SG&A year-over-year in the first quarter was due to
increased selling and marketing investments primarily related to the
preparation for the product launch of Lumigan(TM).
In the first quarter of 2001, research and development expense was
$45.7 million, or 11.5 percent as a ratio to net sales. This was
somewhat lower than anticipated primarily due to timing associated with
the commencement of programs. The company continues to believe that
R&D spending for the year will approximate 12.5 percent of sales.
COPYRIGHT 2001 Worldwide
Videotex Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2001, Gale Group. All rights
reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.