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

Biotech Financial Reports • June, 2001 • broken down by various product lines

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.


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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.


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