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Conceptus Reports First Quarter Financial Results; Essure PMA Recently Filed; Progress Made With European and Canadian Introductions.


Business Editors

SAN CARLOS San Carlos (săn kär`lōs), residential city (1990 pop. 26,167), San Mateo co., W Calif.; inc. 1925. The chief manufactures are plastic products, hardware, and machine parts. , Calif.--(BUSINESS WIRE)--April 24, 2002

Conceptus conceptus /con·cep·tus/ (-tus) the product of the union of oocyte and spermatozoon at any stage of development from fertilization until birth, including extraembryonic membranes as well as the embryo or fetus. , Inc. (Nasdaq:CPTS CPTS Certified Penetration Testing Specialist (network security)
CPTS Comptroller Squadron
CPTS Computer Program Test Specifications
CPTS Catastrophe Personnel Tracking System
CPTS Claims Procedure Training Specialist
), developer of the non-incisional permanent birth control procedure Essure(TM), today announced financial results for the three months ended March 31, 2002. Highlights of the 2002 first quarter and recent weeks include:
-- Early submission of the final Premarket Approval (PMA) application to the
U.S. Food and Drug Administration (FDA) for Essure(TM)

-- Achievement of more than 900 woman-years of effectiveness testing in
clinical trials with 0 reported pregnancies among women relying on Essure

-- Launch of Essure in certain European countries and in Canada by engagement
of well established independent distributors with an existing franchise in
gynecology

-- Expansion of the Company's direct-to-consumer (DTC) activities in Australia
with a fully functioning consumer call center staffed by healthcare
professionals


For the 2002 first quarter, the Company reported a net loss of $5.9 million, or $0.36 per share, compared with a net loss of $4.1 million, or $0.35 per share, in the comparable period last year. 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 the first quarter of 2002 were $276,000, compared with no sales in the first quarter last year; on a sequential-quarter basis, sales of Essure more than doubled. Approximately $110,000 in first quarter 2002 net sales were derived from Europe, of which approximately 50 percent represented first-time orders from distributors, as the Company introduced Essure in several European markets. Cost of sales and start-up manufacturing costs were $746,000 in the 2002 first quarter, representing the cost of early stage product introductions and limited production volumes.

Owing to owing to
prep.
Because of; on account of: I couldn't attend, owing to illness.

owing to prepdebido a, por causa de 
 lower pivotal trial costs, research and development expenses were $2.0 million for the 2002 first quarter, compared with $2.2 million in the prior year's first quarter. Selling, general and administrative expenses were $3.2 million for the three months ended March 31, 2002, compared with $2.1 million last year. The increase was related to sales and marketing activities as the Company introduced Essure in the U.K., Northern Ireland Northern Ireland: see Ireland, Northern.
Northern Ireland

Part of the United Kingdom of Great Britain and Northern Ireland occupying the northeastern portion of the island of Ireland. Area: 5,461 sq mi (14,144 sq km). Population (2001): 1,685,267.
, Spain, Portugal, Finland, Holland, Belgium and Canada, and continued marketing of Essure in Australia.

Cash, cash equivalents, short-term investments and restricted cash were $26.5 million as of March 31, 2002, compared with $33.8 million as of December 31, 2001.

"The past few months have been a time of critically important commercial and regulatory progress at Conceptus," said Steven Bacich, chief executive officer. "Much of Conceptus is tightly focused on preparing for an anticipated launch of Essure in the U.S., making sure manufacturing, sales and marketing are in place for a successful market introduction and beyond. Of particular note, last week we reached a tremendous milestone in submitting the Essure PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
. Clinical data included in our submission will be presented on May 7, 2002 by Professor Rafael Valle, M.D., Northwestern Medical School, at the American College of Obstetricians and Gynecologists The American College of Obstetricians and Gynecologists (ACOG) is a professional association of medical doctors specializing in obstetrics and gynecology in the United States. It has a membership of over 49,000[1] and represents 90 percent of U.S.  (ACOG ACOG American College of Obstetricians and Gynecologists.
ACOG American College of Obstetricians & Gynecologists
) Annual Clinical Meeting, being held in Los Angeles Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850. . One key data finding in our PMA submission was the verification of Conceptus' commercial training program, which to date has yielded similar placement success rates to those reported by our Pivotal Trial clinical investigators, when compared for the first 10 cases."

"In addition, we are very pleased with the initial introduction of Essure in Europe, and in close cooperation with our growing distribution network we are working to bring this important method of permanent birth control now to the women of Denmark, Sweden and Germany. There will be four clinical presentations and a separate symposium on the Essure system at the European Society of Gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic.  Endoscopy endoscopy

Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the
 meeting in Berlin, being held April 26-28," continued Mr. Bacich.

"Our McKesson telephone call center in Australia, designed to provide women with information about permanent birth control options and to answer their questions about Essure, is fully staffed by healthcare professionals and is off to a strong start. Since its opening in March, we have been able to ease the bottleneck at the General Practitioner general practitioner
n. Abbr. GP
A physician whose practice consists of providing ongoing care covering a variety of medical problems in patients of all ages, often including referral to appropriate specialists.
 level as women may now be initially directed to OB/GYNs trained in the Essure procedure. We plan to incorporate a similar call center format in other countries, including the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . In addition, we have continued to market directly to the public hospitals in Australia This is a list of major hospitals in Australia. New South Wales
Public hospitals in New South Wales are organised into eight Area Health Services plus The Children's Hospital at Westmead.
, which represent about 70 percent of that nation's tubal Tubal (t`bəl), in the Bible, son of Japheth.  ligation ligation /li·ga·tion/ (li-ga´shun) the application of a ligature.

tubal ligation  sterilization of the female by constricting, severing, or crushing the uterine tubes.
 procedures, and now are active in public hospitals in every major region there," Mr. Bacich added.

Separately, the Company announced that it has filed suit against Ovion, Inc. seeking a Declaratory Judgment declaratory judgment

In law, a judgment merely declaring a right or establishing the legal status or interpretation of a law or instrument. It is binding but is distinguished from other judgments or court opinions in that it includes no executive element (an order that
 of Patent Non-Infringement, Invalidity and Unenforceability against Ovion's Patent 6,096,052. "We had already requested an interference in the Patent Office in this matter and we plan to vigorously protect our intellectual property rights. Our Essure device is our first commercial product for permanent contraception and we have no intention of allowing others to claim rights to our technology, which we have all worked so diligently to develop and bring to market," commented Mr. Bacich.

Conceptus has scheduled an investor conference call to discuss this announcement beginning at 4:30 p.m. Eastern Time today. Individuals interested in listening to the live conference call via the Internet may do so by logging on to the Company's Website, www.conceptus.com. A replay will be available on the Website for 30 days.

Permanent Birth Control

Surgical tubal ligation has become the most common form of birth control worldwide, despite the fact that it is invasive and costly. About 92 percent of the laparoscopic Laparoscopic
A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen.

Mentioned in: Obstetrical Emergencies
 procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia Anesthesia, General Definition

General anesthesia is the induction of a state of unconsciousness with the absence of pain sensation over the entire body, through the administration of anesthetic drugs.
, requiring between three and four hours of hospital recovery time and four to six days, before returning to regular activities and an average of 10 days for procedures performed via laparotomy laparotomy /lap·a·rot·o·my/ (-rot´ah-me) incision through the flank or, more generally, through any part of the abdominal wall.

lap·a·rot·o·my
n.
1.
. Development of a non-incisional method of tubal ligation has been an elusive goal for researchers since the 1970's.

An Essure procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. Accordingly, a woman is expected to average about 35 minutes pre-op to post-op for an Essure procedure and to return home about 45 minutes after the procedure is completed. 92 percent of Essure patients who were employed returned to work in one day or less, excluding the day of the procedure. Reliance on Essure does not involve taking drugs or hormones.

About Conceptus

Conceptus, Inc. is developing Essure, an investigational medical procedure, designed to provide a non-incisional alternative to tubal ligation, the leading form of birth control worldwide. Essure is currently an investigational device in the United States.

Data from the United Nations show that worldwide, 19 percent of reproductive couples using birth control rely on surgical tubal ligation. Additionally, a survey performed by the United States Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  indicates that surgical tubal ligation continues to be the most prevalent form of birth control in the U.S., and that 41 percent of women age 35-39 and 50 percent of women age 40-44 have had a surgical tubal sterilization sterilization

Any surgical procedure intended to end fertility permanently (see contraception). Such operations remove or interrupt the anatomical pathways through which the cells involved in fertilization travel (see reproductive system).
. An estimated 700,000 surgical tubal ligations are performed each year in the United States.

The Essure procedure is based on a unique and proprietary catheter delivery system for minimally invasive transcervical tubal access. Additional information about Conceptus and the Essure procedure is available at www.conceptus.com.

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory approvals, results of product development programs, and clinical efficacy of and market demand for our product, among other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors such as strategic planning Strategic planning is an organization's process of defining its strategy, or direction, and making decisions on allocating its resources to pursue this strategy, including its capital and people.  decisions by management, re-allocation of internal resources, performance of independent distributors, delays by regulatory authorities, scientific advances by third parties, introduction of competitive products, as well as those factors set forth in the Company's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2001 and other filings with the Securities and Exchange Commission.

                            Conceptus, Inc.
            Condensed Consolidated Statements of Operations
               (In thousands, except per share amounts)

                                                  Three Months Ended
                                                       March 31,
                                                   2002          2001
                                                      (unaudited)

Net sales                                          $ 276          $ -
Operating costs and expenses:
 Cost of sales and start-up manufacturing costs      746            -
 Research and development                          1,982        2,189
 Selling, general and administrative               3,214        2,054
 Total operating costs and expenses                5,942        4,243
Operating loss                                    (5,666)      (4,243)
Other income (expense), net                         (189)         187
Net loss                                        $ (5,855)    $ (4,056)
Basic and diluted net loss per share             $ (0.36)     $ (0.35)
Shares used in computing basic and diluted
 net loss per share                               16,471       11,723


                         Conceptus, Inc.
               Condensed Consolidated Balance Sheets
                           (In thousands)
                                                March 31,    Dec. 31,
                                                   2002        2001
                                               (unaudited)      (a)

Cash, cash equivalents, short-term
 investments and restricted cash              $ 26,496      $ 33,803
Accounts receivable, net                           304           247
Inventories, net                                 1,442         1,134
Other current assets                               801           556
Total current assets                            29,043        35,740
Property and equipment, net                      1,748         1,658
Other assets                                       356           380
Total assets                                  $ 31,147      $ 37,778
Total liabilities                              $ 3,372       $ 4,603
Common stock and additional paid-in capital    118,856       118,397
Other comprehensive loss                            (4)            -
Accumulated deficit                            (91,077)      (85,222)
Total stockholders' equity                      27,775        33,175
Total liabilities and stockholders' equity    $ 31,147      $ 37,778

(a) Derived from audited financial statements.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 24, 2002
Words:1573
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