Conceptus Reports Fourth Quarter Financial Results.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.--(BW HealthWire)--Feb. 22, 2001 Conceptus Inc Conceptus, which is headquartered in Mountain View, California, was founded in 1992. The company began development of micro-catheter and guidewire systems that allowed physicians to access and navigate the fallopian tubes using a non-incisional approach. . (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 STOP(TM) (Selective Tubal Tubal (t  `bəl), in the Bible, son of Japheth. 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. Procedure) non-surgical permanent contraception device for women, today announced financial results for the three and twelve months ended Dec. 31, 2000. For the fourth quarter of 2000, the Company reported a net loss of $6.1 million, or $0.53 per share, compared with a net loss of $2.6 million, or $0.27 per share, in the prior year. R&D expenses increased to $4.7 million, compared with $1.3 million a year ago, as a result of earlier-than-expected completion of bilateral device placement in more than 400 women in the pivotal study of the STOP device. The pivotal study is being conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and from the U.S. Food and Drug Administration (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. ) and requires a minimum of 400 women with bilateral device placement. The clinical endpoints of the study include pregnancy prevention, and safety and comfort during and after the STOP procedure. SG&A expenses in the fourth quarter of 2000 increased to $1.8 million from $1.3 million in 1999, due to the addition of sales and marketing personnel and related spending required to support a commercial launch of the STOP device in Australia. For the year ended Dec. 31, 2000, the Company recorded a net loss of $14.5 million, or $1.37 per share, compared with a net loss of $7.3 million, or $0.76 per share, for the year ended Dec. 31, 1999. Cash and short-term investments at Dec. 31, 2000 were $12.5 million, compared with $10.8 million at Dec. 31, 1999. "We have made considerable progress on a number of fronts, including clinical, regulatory and operations," commented Steve Bacich, president and chief executive officer. "Our attention is now focused on executing our plans for the first commercial launch of the STOP device in Australia, and on securing reimbursement approvals in certain European countries in preparation for a controlled market release in 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. 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 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 90 days. About STOP Surgical 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. has become the most common form of contraception worldwide, despite the fact that it is invasive and costly. About 93% of the 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 4-5 hours of hospital recovery time and resulting in 3-4 days off work. A STOP procedure does not require cutting or penetrating the abdomen; the procedure can be performed with a local anesthetic local anesthetic n. An agent that, when applied directly to mucous membranes or when injected about the nerves, produces loss of sensation by inhibiting nerve excitation or conduction. , thus enabling the procedure to be performed in a less costly office setting. Accordingly, a woman is expected to spend about 2-3 hours of her day for a STOP procedure and have a rapid return to normal activities. The STOP device is a unique and proprietary micro-coil that is deployed permanently into each 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. using the Company's minimally invasive transcervical tubal access catheter system. Once in place, clinical studies have shown that the STOP device induces an occlusive occlusive /oc·clu·sive/ (o-kloo´siv) pertaining to or causing occlusion. oc·clu·sive adj. 1. Occluding or tending to occlude. 2. tissue response. About Conceptus Conceptus Inc. is developing STOP, an innovative medical device and procedure designed to provide a non-surgical alternative to tubal ligation, the leading form of contraception worldwide. Data from the United Nations show that worldwide, 30% of reproductive couples using contraception rely on surgical tubal ligation. Additionally, a survey performed by the 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 contraception in the U.S., and that 35% of women age 35-44 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 800,000 surgical tubal ligations are performed each year in the U.S., of which 93% are performed in a hospital or surgi-center and require general anesthesia. Additional information about the Company and the STOP device 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 products, 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, scientific advances by Conceptus or 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 Dec. 31, 1999 and other filings with the Securities and Exchange Commission.
CONCEPTUS INC.
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended Years Ended
Dec. 31 Dec. 31 Dec. 31 Dec. 31
2000 1999 2000 1999
Unaudited Unaudited
Net sales $ -- $ 13 $ -- $ 95
Cost of sales -- 26 -- 137
Gross loss -- (13) -- (42)
Operating expenses:
Research and development 4,709 1,296 10,739 4,251
Selling, general and
administrative 1,773 1,330 5,012 3,729
Total operating expenses 6,482 2,626 15,751 7,980
Operating loss (6,482) (2,639) (15,751) (8,022)
Recovery of legal defense costs 73 -- 586 --
Interest and other income, net 260 77 712 723
Net loss $(6,149) $(2,562) $(14,453) $(7,299)
Basic and diluted
net loss per share $ (0.53) $ (0.27) $ (1.37) $ (0.76)
Shares used in computing basic
and diluted net loss per share 11,681 9,647 10,559 9,662
Condensed Balance Sheet Data
(In thousands)
Dec. 31 Dec. 31
2000(a) 1999(a)
Cash and short-term investments $12,493 $10,769
Trade accounts receivable, net -- 18
Total current assets 12,619 10,881
PP&E, net 1,153 845
Total assets 14,106 11,903
Accounts payable and accruals 4,147 851
Total current liabilities 4,147 851
Accumulated deficit (67,148) (52,695)
Stockholders' equity 9,959 10,914
(a) Derived from audited financial statements.
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