Conceptus Reports Second Quarter 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.--(BW HealthWire)--July 25, 2002 Significant Recent Accomplishments Include 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. Advisory Committee Approval Recommendation for Essure(TM), Raising $74.2 Million in Equity Capital 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 and six months ended June 30, 2002. Highlights of the 2002 second quarter and recent weeks include: -- The FDA Advisory Committee overwhelmingly recommended conditional approval of Essure, a non-incisional alternative to tubal ligation for women seeking permanent contraception, by a vote of 8-0 with one abstention. -- The Essure PMA (Pre-Market Approval) Application was granted expedited review by the FDA. -- The Company completed a follow-on public offering of 4.5 million shares of common stock at $16.00 per share in June, raising $72.0 million before underwriters' discounts and expenses. An additional 135,000 shares were issued at $16.00 per share in July as part of an underwriters' over-allotment option, raising $2.2 million before underwriters' discounts and expenses. For the second quarter of 2002, net loss was $6.7 million, or $0.40 per share, compared with a net loss of $4.3 million, or $0.32 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 second quarter of 2002 was $406,000, compared with $163,000 for the second quarter of last year, the first quarter of commercial sales for Essure. On a sequential-quarter basis, net sales of Essure increased by 47%. Cost of sales and start-up manufacturing costs were $893,000 in the 2002 second quarter, representing the cost of early stage product manufacturing and growing, but limited, production volumes. For the six months ended June 30, 2002, net sales were $682,000, compared with $163,000 for the six months ended June 30, 2001. The first-half 2002 net loss was $12.5 million, or $0.75 per share, compared with a net loss of $8.3 million, or $0.67 per share, in the comparable period of last year. Research and development expenses increased to $2.3 million for the 2002 second quarter, compared with $1.7 million in the prior year's second quarter. The increase was due to a higher level of expenditures associated with regulatory and clinical affairs pertaining per·tain intr.v. per·tained, per·tain·ing, per·tains 1. To have reference; relate: evidence that pertains to the accident. 2. to the 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 and increased legal costs pertaining to intellectual property matters. Selling, general and administrative expenses were $4.0 million for the three months ended June 30, 2002, compared with $2.3 million last year. The increase was related to on-going sales and marketing activities for Essure in Australia and continuing marketing and distribution activities for Essure in Europe, where new distributorships were established in the second quarter in Germany, Sweden, Switzerland and Turkey. Cash, cash equivalents, short-term investments and restricted cash were $87.6 million as of June 30, 2002, compared with $33.8 million as of December 31, 2001, reflecting the successful completion of the Company's recent follow-on public equity offering. "The second quarter and recent weeks have proven to be a watershed period for Conceptus," said Steven Bacich, chief executive officer. "The principal event during this time, the FDA Advisory Panel's recommendation to approve the Essure PMA, though non-binding on the FDA, represents a major step forward for the Company as we continue to address our goal of building a high-quality, fully integrated medical device company focused on the Essure non-incisional, permanent birth control procedure." Mr. Bacich added, "Our PMA submission occurred on the 19th of April and was granted expedited review by the FDA. In a period of just three months, we received overwhelming support from the FDA Panel to move forward in the FDA approval process. We are confident that we can finalize fi·nal·ize tr.v. fi·nal·ized, fi·nal·iz·ing, fi·nal·iz·es To put into final form; complete or conclude: "They have jointly agreed ... the conditions set forth during the recent Panel meeting in very short order. Separately, we are very pleased with the successful follow-on offering Follow-On Offering An offering of additional shares after a company has had an initial public offering. Notes: This sometimes means the company is strapped for cash. So they need to issue more shares to pay bills or finance a new project. that we completed this past June during a climate of very challenging market conditions. Our successful financing will enable us to prepare for our sales and marketing efforts in the U.S., Europe and other regions of the world, as we continue our transition into a full-fledged commercial entity." 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 catheter /cath·e·ter/ (kath´e-ter)1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid. 2. urethral c. . 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 blockage of intestine, urethra, etc. See obstruction under anatomical location, e.g. intestinal, urethral. blockage Wax, see there 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. . Accordingly, a woman is expected to return home about 45 minutes after the procedure is completed. About Conceptus Conceptus, Inc. is developing Essure, an investigational medical device and procedure in the U.S., 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 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. . The Essure procedure is based on a unique and proprietary implant and 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 and timing of, and conditions placed upon, regulatory approvals for Essure, 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 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 delays by regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities , 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 Six Months Ended
June 30, June 30,
2002 2001 2002 2001
Net sales $ 406 $ 163 $ 682 $ 163
Operating costs and
expenses:
Cost of sales and start-up
manufacturing costs 893 646 1,639 646
Research and development 2,348 1,676 4,330 3,865
Selling, general and
administrative 3,999 2,343 7,213 4,397
Total operating costs
and expenses 7,240 4,665 13,182 8,908
Operating loss (6,834) (4,502) (12,500) (8,745)
Interest and other income
(expense), net 177 215 (12) 402
Net loss $ (6,657) $ (4,287) $ (12,512) $ (8,343)
Basic and diluted net loss
per share $ (0.40) $ (0.32) $ (0.75) $ (0.67)
Shares used in computing
basic and diluted net loss
per share 16,806 13,300 16,640 12,521
Conceptus, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
June 30, December 31,
2002 2001
Cash, cash equivalents, short-term
investments and restricted cash $ 87,560 $ 33,803
Accounts receivable, net 509 247
Inventories, net 1,642 1,134
Other current assets 871 556
Total current assets 90,582 35,740
Property and equipment, net 1,888 1,658
Other assets 439 380
Total assets $ 92,909 $ 37,778
Total liabilities $ 5,018 $ 4,603
Common stock and additional
paid-in capital 185,627 118,397
Accumulated other comprehensive loss (2) --
Accumulated deficit (97,734) (85,222)
Total stockholders' equity 87,891 33,175
Total liabilities and
stockholders' equity $ 92,909 $ 37,778
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