Vivus, Inc.: VVUS (NASDAQ)
VIVUS Reports First Quarter Financial Results
Company Reviews R&D, Clinical and Business Development
MOUNTAIN VIEW, Calif.--April 17, 2002--VIVUS, Inc. (NASDAQ:VVUS),
a pharmaceutical company developing innovative products to improve
quality of life, today reported financial results for the three months
ended March 31, 2002. For the first quarter of 2002, VIVUS reported
a net loss of ($1.9) million, or a ($0.06) net loss per share,
compared with a net loss of ($4.9) million, or a ($0.15) net loss per
share, during the same quarter last year. Research and development
expenses were higher in 2001.
U.S. product revenue was $6.6 million in the first quarter of
2002, a 23% increase over the previous quarter, and compares to $5.2
million for the first quarter of 2001. The Company believes this
increase is a result of targeted marketing programs that were
implemented during the first six months of 2001.
International product revenue was $625 thousand for the first
quarter of 2002, a decrease of $793 thousand over the same period last
year, which included shipments of product to Abbott Laboratories
(NYSE:ABT) to support their launch of MUSE in Europe. Based on
projected sales to its international partners, the Company expects
that international revenue will continue to decline in the second and
third quarters of 2002.
R&D expenses for the first quarter of 2002 were $2.8 million, as
compared to $6.0 million for the same quarter last year. Payments for
licensing TA-1790 as an oral treatment for male erectile dysfunction
were made in the first quarter of 2001. The Company expects that R&D
expenses will continue to increase in 2002 as its products progress in
development.
Cost of goods sold was $3.3 million for the first quarter of 2002,
as compared to $3.6 million for the first quarter of 2001. Gross
margins for the first quarter of 2002 and the first quarter of 2001
were 47% and 43%, respectively. The increase is a result of expected
lower international sales. Selling, general and administrative
expenses in the first quarter of 2002 of $2.7 million were $451
thousand higher than the same period last year due to increased
investment in U.S. sales and marketing efforts and legal expenses
relating to the Janssen arbitration hearing that was held in
mid-March.
During the first quarter of 2002, the Company recorded a tax
benefit of $300 thousand based on an updated estimate of its net tax
liability.
Unrestricted cash, cash equivalents and available-for-sale
securities at March 31, 2002 totaled $35.5 million, down $1.2 million
from $36.7 million at December 31, 2001. This decrease is due
primarily to development expenses for TA-1790, clinical expenses for
ALISTA(TM), our product for the treatment of female sexual
dysfunction, and development and clinical expenses for VI-0134 to
treat premature ejaculation.
Product Pipeline Update
During the first quarter the Company initiated a Phase II/III
at-home study to evaluate the safety and efficacy of ALISTA(TM), for
the treatment of female sexual arousal disorder (FSAD), when used by
the patient in the privacy of her home. The study is a
placebo-controlled, double-blind trial being conducted at multiple
sites throughout the United States.
The Company also began its clinical study designed to evaluate the
safety and efficacy of TA-1790 for the treatment of erectile
dysfunction (ED). TA-1790 is a fast acting, highly selective, potent
oral phosphodiesterase type 5 (PDE5) inhibitor. The study is a
multi-center, double-blind, placebo-controlled evaluation of TA-1790
using Rigiscan(TM) assessment of erectile response.
VIVUS is completing a pharmacokinetic study with VI-0134, its oral
on-demand treatment for PE, and the Company expects to initiate Phase
II clinical trials in PE in the second half of 2002.
VIVUS, Inc. is a pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, with a focus on sexual dysfunction. Current development programs target Female Sexual Dysfunction (FSD), Erectile Dysfunction (ED) and Premature Ejaculation (PE). The Company developed
and markets in the U.S. MUSE(R) (alprostadil) and ACTIS(R), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE:ABT) for the internationalmarketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Labs (TSE:PLB) to market and distribute MUSE.
CONTACT: VIVUS, Inc.
Richard Walliser, 650/934-5200
ir@vivus.com
www.vivus.com
or
Lippert/Heilshorn & Associates, Inc.
Bruce Voss, 310/691-7100 (Investors)
bvoss@lhai.com
Jody Cain, 310/691-7100 (Investors)
jcain@lhai.com
Elissa Grabowski, 212/838-3777 (Media)
egrabowski@lhai.com
www.lhai.com |
