Conceptus Reports Fourth Quarter and Year-end Results; STOP Investigational Device Exemption Filed; Company Outlines Milestones for Coming Year.

Business Editors, Health/Medical Writers

SAN CARLOS, Calif.--(BW HealthWire)--March 22, 2000

Conceptus, Inc. (NASDAQ NM: CPTS), developer of the STOP(tm) (Selective Tubal Occlusion Procedure) non-surgical permanent contraception device for women, today announced financial results for the three and 12 months ended December 31, 1999.

For the 1999 fourth quarter, the Company reported a net loss of $1.9 million, or $0.19 per share, compared with a net loss of $1.0 million, or $0.11 per share, in 1998. Research, development and regulatory expenses increased 176% to $1.3 million, as Conceptus continued to develop its STOP device, expanded enrollment in its Phase II study in Australia, Europe and the U.S., and prepared for the commencement of its STOP international pivotal trial.

For the year ended December 31, 1999, the Company posted a net loss of $6.6 million, or $0.68 per share, which includes $850,000 related to non-recurring legal and consulting fees. This compares with a net loss of $9.7 million, or $1.01 per share, in 1998, which included approximately $1.0 million in non-recurring and restructuring costs. The decrease in net loss reflects a full year of cost savings due to this restructuring effected in July 1998. Cash and cash equivalents were $10.8 million at December 31, 1999.

The Company also announced the filing with the Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) in order to pursue commencement of its pivotal trial of STOP. "We anticipate that our IDE will be approved during the second quarter of 2000, after which enrollment will begin in the U.S., Europe and Australia," said Steven Bacich, president and chief executive officer. The study is designed to measure the safety and effectiveness of the STOP device, a non-surgical permanent contraceptive device designed to be less invasive than the 800,000 U.S. and 16 million worldwide surgical tubal ligation procedures performed annually. STOP also represents a drug-free alternative to long-term use of oral contraceptives, IUDs or hormonal implants.

"Surgical tubal ligation has become the most common form of contraception

worldwide, despite the fact that it is invasive and costly," commented Mr. Bacich. "A vast majority of the procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, requiring 4-5 hours of hospital recovery time and resulting in 3-4 days off work. In contrast, because a STOP procedure does not require cutting or penetrating the abdomen, the procedure can be performed with local sedation, 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 designed to be deployed permanently into each fallopian tube using the Company's minimally invasive transcervical tubal access catheter system. Once in place, clinical studies have shown that the STOP device induces a tissue response that occludes the lumen of the fallopian tube. In the Phase II study of STOP, as of February 29, 2000, more than 500 women-months of effectiveness data have been accumulated with no reported pregnancies, and a low rate of adverse events. Importantly, in excess of 95% of all patients in the study have reported that the comfort of wearing the STOP device is "very good to excellent" at each follow-up point completed thus far after device placement.

In conjunction with the commencement of the pivotal study of STOP, Conceptus plans to host a satellite broadcast of a live STOP procedure at the annual meeting of the International Society of Gynecological Endoscopy (ISGE) in mid-April. The Company's first presentation of a live STOP case occurred in November 1999 at the annual meeting of the American Association of Gynecological Laparoscopists (AAGL) in Las Vegas. "During the AAGL conference we hosted a meeting of physicians in order to communicate the results of our Phase II study of STOP," added Mr. Bacich. "We also broadcast via satellite a live STOP case, which was performed in less than five minutes on a wide-awake, obviously comfortable patient. There were more than 100 physicians attending our meeting, and they were able to ask questions of both the physician placing the STOP device and of the patient."

Although marketing of the STOP device in the U.S. will require successful completion of the pivotal study and FDA approval, Conceptus plans to begin marketing the STOP device in select international markets beginning in 2001. The Company is actively assessing options for global distribution, and expects to obtain a CE mark by calendar year-end.

Conceptus expects the cash burn rate to increase to an average of $1.0 million per month during 2000. The Company has sufficient capital to complete enrollment in the pivotal trial, and may seek additional capital in order to commercialize STOP.

Conceptus, Inc. is developing STOP, an innovative medical device designed to provide a non-surgical alternative to surgical 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. A survey performed by the Centers for Disease Control indicates that surgical tubal ligation is the No. 1 form of contraception in the U.S., and that 35% of women age 35-44 have had a tubal ligation. 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.

Conceptus has scheduled an investor conference call beginning at 4:30 p.m. Eastern Time today to discuss the Company's 1999 results. To participate in the call, a few minutes prior to the start time please dial [phone]. Those unable to participate are invited to listen to a recording of the call and Q&A through 6:30 p.m. Eastern Time March 24 by dialing [phone], access code 14579447.

Alternatively, individual investors are invited to listen to the conference call over the Internet through Vcall, a service of the Investor Broadcast Network, at www.vcall.com. To listen to the live call, please go to the Web site at least 15 minutes prior to the start of the call to register, download and install any necessary audio software. A replay will begin shortly after the call has ended and will be available for 90 days.

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. 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 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 for the year ended December 31, 1998 and other filings with the Securities and Exchange Commission.

                          (Tables to follow)


                           CONCEPTUS, INC.
                       STATEMENTS OF OPERATIONS

                 (In thousands, except per share data)
                              (Unaudited)

                          Three Months Ended       Twelve Months Ended
                         --------------------     --------------------
                          Dec. 31,  Dec. 31,       Dec. 31,  Dec. 31,
                            1999      1998           1999      1998
                         ---------------------------------------------

Net sales                $     13  $    111       $     95  $    449

Cost of sales                  26       115            137     1,702
                         --------  --------       --------  --------

Gross profit
 (loss)                       (13)       (4)           (42)   (1,253)

Operating
 expenses:
R&D and
 regulatory                 1,296       470          4,251     4,317
Selling,
 general and
 administrative
                              643       799          3,042     5,349
                         --------  --------       --------  --------

Total operating
 expenses                   1,939     1,269          7,293     9,666
                         --------  --------       --------  --------

Operating
 income (loss)             (1,952)   (1,273)        (7,335)  (10,919)

Interest and
 investment
 income, net                   77       258            723     1,254
                         --------  --------       --------  --------

Net income
 (loss)                  $ (1,875) $ (1,015)      $ (6,612) $ (9,665)
                         ========  ========       ========  ========

Net income
 (loss) per
 share                   $  (0.19) $  (0.11)      $  (0.68) $  (1.01)
                         ========  ========       ========  ========

Shares used in
 computing basic
 and diluted net
 income (loss)
 per share                  9,662     9,616          9,662     9,562


                     Condensed Balance Sheet Data
                            (In thousands)

                                           December 31,   December 31,
                                              1999           1998
                                           -----------    -----------
                                               (1)            (1)
Cash, cash equivalents
 and short-term investments                $    10,769    $    17,071


Trade accounts receivable, net                      18            139

Total current assets(2)                         11,568         17,275

PP&E, net                                          845          1,391

Total assets                                    12,590         19,031

Accounts payable and accruals                      754            678

Total current liabilities                          851            775


Accumulated deficit                            (52,008)       (45,396)


Stockholders' equity                            11,601         18,014


     (1) Derived from audited financial statements.

     (2) Includes a receivable in the amount of $686,000 for legal
defense costs expected to be reimbursed by the Company's D&O insurance
policy.