Conceptus Reports First Quarter Financial Results; Initial Australian Consumer Awareness Campaign Generates High Response Rate From Women.Business Editors/Health 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)--April 26, 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 birth control device for women, today announced financial results for the three months ended March 31, 2001. For the first quarter of 2001, the company reported a net loss of $4.1 million, or $0.35 per share, compared with a net loss of $1.8 million, or $0.18 per share, in the prior year. Research and development expenses increased to $2.2 million, compared with $1.6 million a year ago, primarily due to expenses related to development and testing activities in preparation for commercial manufacture. Selling, general and administrative expenses in the first quarter of 2001 increased to $2.1 million from $822,000 in 2000, primarily due to the addition of sales and marketing personnel and related spending required to support the commercial launch of the STOP device in Australia. Cash, cash equivalents and short-term investments as of March 31, 2001, were $6.9 million, compared with $12.5 million as of Dec. 31, 2000. On April 12, 2001, the company announced the closing of a private placement financing of approximately 1,643,000 newly issued shares of common stock, which raised a total of $11.5 million. "Because we concluded our pivotal study earlier than planned, we were able to fully focus on the preparatory activities for the commercial introduction of STOP in Australia," stated Steven Bacich, president and chief executive officer. "Our consumer awareness test campaign, which consisted of a radio advertising run over a 10 day period in Sydney and Adelaide, generated over 1,400 responses from potential patients. This enthusiastic response well exceeded our expectations," he added. During the First Quarter 2001, Conceptus' preparation activities for market launch in Australia included the following: -- Staffed and trained selling organization in Australia. -- Negotiated reimbursement with several key private insurance companies. Completed reimbursement validation testing. -- Implemented a high-quality physician training and peer-to-peer proctoring program. Conducted first training sessions; more than 30 Australian physicians will have completed training by mid-year and ahead of the product launch schedule. -- Developed and implemented an awareness program directed at general practitioners and gynecologists in regards to patient counseling and referral. -- Completed consumer market research program. -- Ran initial consumer awareness test campaign directing women to their general practitioners for counseling and potential referral for a STOP procedure. A full consumer awareness effort began in the second quarter. A key element of the STOP market introduction is physician training and proctoring. Physician training will be available to all qualified gynecologists in Australia, and it is expected that STOP will be offered in Sydney, Melbourne and Adelaide at up to six sites by late May. Additional sites in Brisbane and other areas are expected to be performing procedures by mid-year 2001. "The introduction of STOP, the first non-surgical permanent birth control option for women, is occurring in the wake of improving data from our pivotal study of STOP," stated Bacich. "We are very encouraged by the results of the first interim review of STOP pivotal trial data. As reported on March 29, 2001, many of the key metrics metrics Managed care A popular term for standards by which the quality of a product, service, or outcome of a particular form of Pt management is evaluated. See TQM. have improved versus the interim data from the earlier Phase II study, and patients continued to rate highly their tolerance of the procedure and their comfort with extended use of the device," he added. Combining both the interim results of the Phase II and pivotal trial studies, more than 275 women years of effectiveness have been achieved without a pregnancy. The company cautions however that no method of birth control is 100% effective and pregnancies are expected. In addition, the success criteria for the pivotal trial allow for pregnancies to occur. 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 Web site, www.conceptus.com. A replay will be available on the Web site 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 birth control worldwide, despite the fact that it is invasive and costly. 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. , about 93% of such procedures 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 away from work. A STOP procedure does not require cutting or penetration of the abdomen abdomen, in humans and other vertebrates, portion of the trunk between the diaphragm and lower pelvis. In humans the wall of the abdomen is a muscular structure covered by fascia, fat, and skin. , and 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. in a less costly office setting. Accordingly, a patient is expected to spend about 2-3 hours of her day for a STOP procedure, with a rapid return to normal activities. About Conceptus Conceptus Inc. is developing STOP, an investigational medical device and procedure in the United States, which is designed to provide a non-surgical alternative to surgical tubal ligation, the leading form of birth control worldwide. The STOP device is a unique and proprietary micro-coil designed to be 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 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. system. Clinical studies have shown that the STOP device induces a benign 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 once in place. Data from the United Nations show that worldwide, 30% of reproductive couples using contraception contraception: see birth control. contraception Birth control by prevention of conception or impregnation. The most common method is sterilization. The most effective temporary methods are nearly 99% effective if used consistently and correctly. 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 United States, 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 700,000 surgical tubal ligations are performed each year in the United States. 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 news 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 effectiveness 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, such as uncertainty of market acceptance of STOP, the company's limited operating history, 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 regarding product marketing approvals or reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. , 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 Dec. 31, 2000, and other filings with the Securities and Exchange Commission.
Conceptus Inc.
Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
Three Months Ended
March 31,
2001 2000
Operating expenses:
Research and development 2,189 1,568
Selling, general and administrative 2,054 822
Total operating expenses 4,243 2,390
Operating loss (4,243) (2,390)
Recovery of legal defense costs -- 453
Interest and other, net 187 178
Net loss $ (4,056) $ (1,759)
Basic and diluted net loss per share $ (0.35) $ (0.18)
Shares used in computing basic
and diluted net loss per share 11,723 9,680
-0-
Conceptus Inc.
Condensed Balance Sheet Data
(In thousands)
March 31, Dec. 31,
2001 2000
(Unaudited) (a)
Cash, cash equivalents and
short-term investments $ 6,880 $ 12,493
Inventory 444 67
Other current assets 299 59
Total current assets 7,623 12,619
Property and equipment, net 1,136 1,153
Other assets 409 334
Total assets 9,168 14,106
Accounts payable and accruals 3,208 4,147
Common stock 77,164 77,107
Accumulated deficit (71,204) (67,148)
Stockholders' equity 5,960 9,959
Total liabilities and stockholders' equity 9,168 14,106
(a) Derived from audited financial statements.
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