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ALLERGAN REPORTS FIRST QTR. 8.8% INCREASE IN WORLDWIDE SALES.


Allergan, Inc. (NYSE NYSE

See: New York Stock Exchange
:AGN AGN Again (Amateur Radio)
AGN Active Galactic Nucleus
AGN Acute Glomerulonephritis
AGN Accountants Global Network
AGN Air Gabon (ICAO code) 
), 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 diluted earnings per share

An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of
 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 SFAS Statement of Financial Accounting Standards
SFAS Special Forces Assessment and Selection
SFAS Student Financial Aid Services
SFAS Sport Fishing Association of Singapore
SFAS Safety Features Actuation System
SFAS Statewide Fixed Assets System
 No. 133 discussed later in this document), an unrealized gain Unrealized Gain

A profit that results from holding on to an asset rather than cashing it in and using the funds.

Notes:
Let's say you own a stock that has doubled, but you haven't sold it yet. This is said to be an unrealized gain.
 on derivative instruments Derivative instruments

Contracts such as options and futures whose price is derived from the price of an underlying financial asset.
 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
), BOTOX Cosmetic(TM) by the Canadian Health Authorities and Sensar(TM) by the Ministry of Health and Welfare The Ministry of Health and Welfare is a branch of the government of South Korea. External links
  • Official website


    
 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 See Y2K problem and Y2K compliant.

Y2K - Year 2000
 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 tartrate /tar·trate/ (tahr´trat) a salt of tartaric acid.

tar·trate
n.
A salt or ester of tartaric acid.



tartrate

a salt of tartaric acid.
 Ophthalmic Solution ophthalmic solution
n.
A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops.
 0.2%), indicated for lowering intraocular pressure intraocular pressure
n.
The pressure of the intraocular fluid within the eye.


intraocular pressure (in´tr
 (IOP IOP

intraocular pressure.

IOP Intraocular pressure, see there
) in patients with ocular hypertension or primary open angle glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). , 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 o·pen-an·gle glaucoma
n.
Primary glaucoma in which the aqueous humor has free access to the trabecular reticulum. Also called simple 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 photodynamic therapy
n.
A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells.
 to treat age-related macular degeneration Age-related macular degeneration (ARMD)
Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60.
 from Photochemical photochemical

in laser treatment, the laser light is absorbed and converted into chemical energy.
 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 Net Sales

The amount a seller receives from the buyer after costs associated with the sale are deducted.

Notes:
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight
 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 botulinum toxin type A

Botox, Botox Cosmetic, Dysport (UK), Vistabel (UK)

Pharmacologic class: Neurotoxin

Therapeutic class: Neuromuscular blocker

Pregnancy risk category C

Action

) Purified Neurotoxin neurotoxin /neu·ro·tox·in/ (noor´o-tok?sin) a substance that is poisonous or destructive to nerve tissue.

neu·ro·tox·in
n.
See neurolysin.
 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 pro·ce·rus muscle
n.
A muscle with origin from the membrane covering the bridge of the nose, with insertion into the frontal bone, with nerve supply from a branch of the facial nerve, and whose action assists the frontal bone.
 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 SBLA Supplemental Biologics License Application
SBLA Small Business Loans Act (Canada)
SBLA State Boating Law Administrator
SBLA Sealed Bipolar Lead Acid (battery)
SBLA Self-Bounding Learning Algorithm
) 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 OTC

See: Over-the-counter.


OTC

See over-the-counter market (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 phacoemulsification /phaco·emul·si·fi·ca·tion/ (-e-mul?si-fi-ka´shun) a method of cataract extraction in which the lens is fragmented by ultrasonic vibrations and simultaneously irrigated and aspirated.  machines, and the number of elective cataract surgery Cataract Surgery Definition

Cataract surgery is a procedure performed to remove a cloudy lens from the eye; usually an intraocular lens is implanted at the same time.
Purpose

The purpose of cataract surgery is to restore clear vision.
 procedures.

Following the end of the quarter, Sensar(TM), Allergan's foldable acrylic intraocular lens Intraocular lens
Lens made of silicone or plastic placed within the eye; can be corrective.

Mentioned in: Cataract Surgery
 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 Refractive surgery
A surgical procedure that corrects visual defects.

Mentioned in: Photorefractive Keratectomy and Laser-Assisted In-Situ Keratomileusis

refractive surgery 
.

Contact Lens contact lens, thin plastic lens worn between the eye and eyelid that may be used instead of eyeglasses. Actors, models, and others wear them for appearance, and athletes use them for safety and convenience.  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.

At March 30, 2001, Allergan's consolidated net worth was $878.7 million. Cash net of debt was $114.1 million as the company held $747.4 million in cash compared to $633.3 million in debt as of this same date. Allergan's debt-to-capital percentage was 41.9 percent at March 30, 2001. As of March 30, 2001, the company's days-sales-outstanding was 68. The company's inventory days-on-hand level was 118 as of March 30, 2001.

Earnings Per Share Impact by Adoption of SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities" and Non-Recurring Items

First quarter 2001 diluted earnings per share of $0.39 included a net gain of $0.02 per share, resulting from a non-recurring $0.01 per share loss, net of tax, from the cumulative effect of a change in accounting principle (adoption of SFAS No. 133 on January 1, 2001) and a $0.03 per share after-tax unrealized non-cash gain on derivative instruments. The unrealized gain on derivative instruments is related to the marked-to-market value of derivatives used for foreign-exchange hedging activities Allergan employs to protect against market volatility and its related impact on the company's earnings. As a matter of policy, Allergan does not and will not enter into what would be considered speculative positions with respect to the derivatives it utilizes. Upon the adoption of SFAS No. 133, the company's management decided not to designate these derivative instruments as accounting hedges. As a result, the company has quantified and will continue to quantify the non-cash impact of the marked-to-market value of the contracts on its income statement under the heading unrealized gain on derivative instruments. In the first quarter of 2000, Allergan's diluted earnings per share of $0.33 included a $0.01 per share non-recurring investment gain.

Financial Outlook for 2001

Allergan believes that quarterly earnings per share for 2001 will increase by approximately 18 percent in the second quarter and in excess of 20 percent for the third and fourth quarters when compared with the corresponding prior-year quarters and has increased its 2001 earnings per share objective to $1.93. Based on prevailing currency rates, the company estimates second quarter 2001 sales in the range of $415 million to $425 million and earnings per share of approximately $0.46 excluding the $40 million one-time charge related to in-process research and development as a result of acquiring Allergan Specialty Therapeutics, Inc. These estimates reflect and anticipate a negative effect from currency of more than three percent on sales.

Allergan Inc.

Allergan, Inc., headquartered in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care pharmaceutical, ophthalmic surgical device, over-the-counter contact lens care, movement disorder, and dermatological markets that deliver value to our customers, satisfy unmet medical needs and improve patients' lives.

For more information, call (714)246-5621 or visit http://www.allergan.com.
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Title Annotation:broken down by various product lines
Comment:ALLERGAN REPORTS FIRST QTR. 8.8% INCREASE IN WORLDWIDE SALES.(broken down by various product lines)
Publication:Biotech Financial Reports
Article Type:Statistical Data Included
Geographic Code:1USA
Date:Jun 1, 2001
Words:2005
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