Conceptus Reports Fourth Quarter and Full Year Financial Results.Business Editors/Health & Medical Writers 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)--Feb. 26, 2003 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 and year ended December 31, 2002. Highlights of the 2002 fourth quarter and subsequent weeks in 2003 include: -- FDA approval of Essure in November and initial market introduction in the U.S. -- Positive reimbursement progress among payors -- Fully enrolled physician training sessions -- Formal market launch scheduled at the American College of Obstetrics and Gynecology (ACOG) meeting in April For the fourth quarter of 2002, Conceptus reported a net loss of $11.9 million, or $0.56 per share, compared with a net loss of $5.3 million, or $0.34 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 fourth quarter of 2002 were $465,000, up from $115,000 for the fourth quarter of last year. The increase was attributable to increased commercial sales of Essure. Cost of sales and start-up manufacturing costs, representing the cost of early stage product manufacturing and limited production volumes, were $658,000 in the 2002 fourth quarter, compared with $273,000 in the 2001 fourth quarter. Research and development expenses declined to $1.7 million for the 2002 fourth quarter, from $2.2 million in the prior-year fourth quarter. The decline reflects the decreasing trend of clinical and regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: 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 . Selling, general and administrative expenses were approximately $10.2 million for the three months ended December 31, 2002, compared with $3.1 million in the comparable period last year. The increase was primarily related to the progressive build out of the U.S. sales and marketing organization, as well as activities related to physician training and initial advertising and public relations public relations, activities and policies used to create public interest in a person, idea, product, institution, or business establishment. By its nature, public relations is devoted to serving particular interests by presenting them to the public in the most efforts to market Essure in the U.S. For the year ended December 31, 2002, the Company reported a net loss of $32.5 million, or $1.71 per share, compared with a net loss of $18.1 million, or $1.33 per share, in the prior year. Net sales during 2002 were $1.7 million, compared with $401,000 during 2001. Cash, cash equivalents, short-term investments and restricted cash were $70.7 million as of December 31, 2002, compared with $33.8 million as of December 31, 2001. The increase reflects the successful completion of a follow-on public equity offering in June 2002. "We are very pleased with the pace of the Essure product introduction, and have held physician training sessions in a number of cities across the U.S. with over 500 attendees to date," commented Steve Bacich, president and chief executive officer. "We are in the process of performing preceptoring cases with these physicians with the ultimate goal of hitting our target of training and preceptoring up to 700 physicians by the end of 2003. Moving doctors into their preceptoring phase requires the completion of many logistical steps, each of which takes time. The steps of introducing Essure into some new facilities include the process of obtaining approvals from new technology review or purchasing committees and working with the payor community on obtaining reimbursement. These steps hold true for the introduction of any new medical technology or procedure. On a high note, claims submitted to date on Essure have been paid by the payors. As a critical step in the adoption of Essure, the greater clarity as to reimbursement levels and billing practices we are seeing will allow us to share this information with new customers. "In addition to the programs planned for our upcoming formal launch of Essure at the ACOG ACOG American College of Obstetricians and Gynecologists. ACOG American College of Obstetricians & Gynecologists meeting in New Orleans New Orleans (ôr`lēənz –lənz, ôrlēnz`), city (2006 pop. 187,525), coextensive with Orleans parish, SE La., between the Mississippi River and Lake Pontchartrain, 107 mi (172 km) by water from the river mouth; founded on April 26-30, we are proud of the fact that the Essure product will be a main topic of the Continuing Medical Education continuing medical education See CME. (CME CME See: Chicago Mercantile Exchange CME See Chicago Mercantile Exchange (CME). ) symposia sym·po·si·a n. A plural of symposium. at this meeting as well as the subject of two additional presentations. The formal launch at this meeting will be timed with the roll out of direct-to-consumer and media awareness programs in certain regions of the U.S. where an installed base of trained physicians has been established. We are excited about the foundation we are laying for Essure and the future that is being created for it," continued 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. About Essure Essure deploys a soft micro-insert into the fallopian tube fallopian tube (fəlō`pēən), either of a pair of tubes extending from the uterus to the paired ovaries in the human female, also called oviducts, technically known as the uterine tube. through the cervix cervix /cer·vix/ (ser´viks) pl. cer´vices [L.] 1. neck. 2. the front portion of the neck. 3. cervix uteri. using a minimally invasive transcervical tubal Tubal (t  `bəl), in the Bible, son of Japheth. access
catheter. Once in place, the device is designed to elicit tissue growth
in and around the micro-insert to form an occlusion occlusion /oc·clu·sion/ (o-kloo´zhun)1. obstruction. 2. the trapping of a liquid or gas within cavities in a solid or on its surface. 3. or blockage in the fallopian tube. An Essure procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without 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. . A woman is expected to return home about 45 minutes after the procedure is completed. About Conceptus Conceptus, Inc. manufactures and markets Essure, which is designed to provide a non-incisional alternative to tubal 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. , the leading form of birth control worldwide. The availability of Essure in the U.S. is expected to open up a market currently occupied by surgical tubal ligation and vasectomy vasectomy, male sterilization by surgical excision of the vas deferens, the thin duct that carries sperm cells from the testicles to the prostate and the penis. , which combined account for over 1 million procedures annually in 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. . 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, the accuracy of which is necessarily subject to risks and uncertainties. Clinical efficacy of and market demand for our product, the results of our marketing programs and levels of payor reimbursement, 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 within the Company's control, 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 and re-allocation of internal resources, or on factors outside of the Company's control, such as decisions by regulatory authorities and insurance carriers, scientific advances by third parties and 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
(Unaudited, in thousands, except per share amounts)
Three Months Ended Year Ended
December 31, December 31,
2002 2001 2002 2001
Net sales $465 $115 $1,650 $401
Operating costs and expenses:
Cost of sales and start-up
manufacturing costs 658 273 3,142 1,456
Research and development 1,730 2,165 8,230 7,983
Selling, general and
administrative 10,210 3,145 23,417 9,776
Total operating costs and
expenses 12,598 5,583 34,789 19,215
Operating loss (12,133) (5,468) (33,139) (18,814)
Interest and other income, net 282 195 629 740
Net loss $(11,851) $(5,273) $(32,510) $(18,074)
Basic and diluted net loss per
share $(0.56) $(0.34) $(1.71) $(1.33)
Shares used in computing basic
and diluted net loss per share 21,297 15,443 18,968 13,561
Conceptus, Inc.
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
December 31,
2002 2001
Cash, cash equivalents, short-term investments and
restricted cash $70,734 $33,803
Accounts receivable, net 581 247
Inventories, net 2,524 1,134
Other current assets 797 556
Total current assets 74,636 35,740
Property and equipment, net 2,474 1,658
Other assets 185 380
Total assets $77,295 $37,778
Current liabilities $6,364 $4,117
Long term liabilities 217 486
Common stock 188,435 118,397
Accumulated other comprehensive income 11 -
Accumulated deficit (117,732) (85,222)
Total stockholders' equity 70,714 33,175
Total liabilities and stockholders' equity $77,295 $37,778
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