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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

For the Fiscal Quarter Ended September 30, 2002

For the transition period from __________ to __________.

Commission file number:  0-27596

CONCEPTUS, INC.
(Exact name of registrant as specified in its charter)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for at least the past 90 days.

As of October 31, 2002, 21,283,305 shares of the registrant’s Common Stock were outstanding.

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CONCEPTUS, INC.

FORM 10-Q for the Three and Nine Months Ended September 30, 2002

INDEX

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PART I: FINANCIAL INFORMATION

ITEM 1.  Financial Statements

Conceptus, Inc.

Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)

The accompanying notes are an intergral part of these condensed consolidated financial statements

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Conceptus, Inc.

Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)

The accompanying notes are an integral part of these condensed consolidated financial statements.

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Conceptus, Inc.

Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)

The accompanying notes are an integral part of these condensed consolidated financial statements.

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)

1.       Basis of Presentation

          The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the instructions to Form 10-Q and Article 10-01 of Regulation S-X.  Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements.  In the opinion of management, all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair presentation have been included.

          The balance sheet at December 31, 2001 has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. This financial data should be reviewed in conjunction with the audited consolidated financial statements and related notes included in the Company’s Form 10-K for the year ended December 31, 2001.  The results of operations for the three and nine months ended September 30, 2002 may not necessarily be indicative of the operating results for the full 2002 fiscal year or any other future interim periods.

          Certain amounts in the prior quarters’ financial statements have been reclassified to conform to the current presentation.   These reclassifications did not change previously reported net loss, total assets or stockholders’ equity.

2.       Inventories

          Inventories are stated at the lower of cost or market.  Cost is based on actual costs computed on a first-in, first-out basis.  The components of inventories consist of the following:

3.       Stockholder’s Equity

          On June 26, 2002, the Company completed a follow-on public offering in which it sold 4.5 million shares of common stock for $16.00 per share.  The net proceeds to the Company from the sale of the shares were approximately $66.8 million, net of underwriting discounts, commissions and other offering costs. 

          On July 24, 2002, the underwriters exercised the over-allotment option related to the follow-on public offering completed in June 2002, and the Company issued an additional 135,000 shares of common stock at $16.00 per share.  The net proceeds to the Company from the sale of the additional shares were approximately $2.0 million after underwriting discounts and commissions.

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          Basic net loss per share is computed using the weighted average number of common shares outstanding during the period.  Diluted net loss per share is computed using the weighted average number of common and dilutive common equivalent shares outstanding during each period.  Under the requirements for calculating basic net loss per share, the effect of potentially dilutive securities such as stock options are excluded.  Basic and diluted net loss per share are equivalent for all periods presented due to the Company’s net loss position.

          During all periods presented, the Company had securities outstanding, which could potentially dilute basic earnings per share in the future, but were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive.  These outstanding securities consisted of stock options of 3,437,134 and 2,591,158 shares as of September 30, 2002 and 2001, respectively.

5.       Comprehensive Loss

          Total comprehensive loss for the nine months ended September 30, 2002 consisted of unrealized foreign currency translation losses of approximately $2,000 and net loss of $20.7 million, as unrealized gains and losses on available-for-sale investments were immaterial.  Total comprehensive loss for the three months ended September 30, 2002 consisted of net loss of $8.1 million, as unrealized foreign currency translation losses and unrealized gains and losses on available-for-sale investments were immaterial.  For the three and nine months ended September 30, 2001, total comprehensive loss approximates net loss as unrealized gains and losses on available-for-sale investments were immaterial.

6.       Recent Accounting Pronouncements

          In April of 2002, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards No. 145 (“SFAS 145”), “Rescission of FASB Statements No. 4, 44 and 64, Amendment of FASB Statement No. 13, and Technical Corrections,” which is effective for fiscal years beginning after May 15, 2002.  Under SFAS 145, gains and losses from the extinguishment of debt should be classified as extraordinary items only if they meet the criteria of Accounting Principles Board Opinion No. 30.  SFAS 145 also addresses financial accounting and reporting for capital leases that are modified in such a way as to give rise to a new agreement classified as an operating lease.  The Company believes that the adoption of SFAS 145 will not have a material impact on the consolidated financial position or results of the operations of the Company.

          In June of 2002, the FASB issued Statement of Financial Accounting Standards No. 146 (“SFAS 146”), “Accounting for Costs Associated with Exit or Disposal Activities,” which is effective for exit or disposal activities initiated after December 31, 2002.  SFAS 146 nullifies Emerging Issues Task Force Issue No. 94-3, “Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring).”  Under SFAS 146, a liability is required to be recognized for a cost associated with an exit or disposal activity when the liability is incurred.  SFAS 146 applies to costs associated with an exit activity that does not involve an entity newly acquired in a business combination or with a retirement or disposal activity covered by FASB Statements No. 143, “Accounting for Asset Retirement Obligations,” and No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets”.  The Company believes that the adoption of SFAS 146 will not have a material impact on the consolidated financial position or results of the operations of the Company.

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Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

          The following discussion should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included in Part I-Item 1 of this Quarterly Report.  In addition, the following discussion contains forward-looking statements within the meaning of Section 21 E of the Securities Exchange Act of 1934, as amended.  We wish to alert readers that the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2001, as well as the risk factors set forth below under “Risk Factors”, as well as other factors could in the future affect, and in the past have affected, our actual results and could cause our results for future periods to differ materially from those expressed or implied in any forward-looking statements made by us.

Overview

          We develop, manufacture and market Essure, an innovative and proprietary non-incisional permanent birth control device for women.  Essure is a soft and flexible micro-insert delivered into a woman’s fallopian tubes and is designed to provide permanent birth control by causing a benign tissue in-growth that blocks the fallopian tubes.  The procedure to place our Essure micro-insert, which we refer to as the Essure placement procedure, is typically performed as an outpatient procedure and is intended to be a less invasive and less costly alternative to tubal ligation, the leading form of birth control in the U.S. and worldwide.

          We commenced an international Pivotal trial in May 2000 to obtain 12-month safety, effectiveness and patient satisfaction data on 400 women to support the submission of a Pre-Market Approval, or PMA, application with the U.S. Food and Drug Administration, or FDA.  Additionally, we have an ongoing Phase II clinical study for the safety and effectiveness of Essure that was initiated in November 1998.  Based on zero reported pregnancies in women relying on Essure (as of October, 2002) between our Phase II clinical study and Pivotal trials, statistical analysis supports an one-year effectiveness rate of 99.8%.  In April 2002, based on data from our trials, we submitted our PMA application to the FDA, which was granted an expedited review.   In November 2002, we received written notification from the FDA that they have approved the PMA application.  This significant milestone allows us to begin the marketing and distribution effort of Essure in the U.S.  

          In our previous discussions with the FDA, and as part of the study design of our Phase II and Pivotal trials, we have agreed to follow our clinical trial patients for a five-year period following the Essure placement procedure.  The information from this planned long-term post-approval study will provide relevant information for our U.S. commercialization, as well as allow us to publish data at the conclusion of the follow-up period.  In addition, a post-approval study to evaluate placement rates among newly trained physicians will be conducted.  This study will involve the first 20 cases performed after preceptoring is completed among 40 physicians in major metropolitan areas.

          We increased hiring activity in our U.S. sales, training and marketing divisions during the third quarter of 2002 in preparation for the launch of Essure in the U.S. following its FDA approval.  We currently have professional trainers and sales representatives in more than 20 states across the U.S.  Our trainers will be focused on physician training and will closely monitor the length of time required for U.S. physicians to adopt Essure as a routine part of their gynecological practice.  We will initially target large-group gynecological practices with the goal of training 500 to 700 physicians by the end of 2003.  Simultaneously, we will be setting up a U.S. call center to answer questions patients may have regarding Essure. 

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          Internationally, we currently market Essure in Australia, Singapore, Canada and 14 European markets.  In Australia, we are continuing our sales, marketing and training efforts.  We are also continuing to market directly to public hospitals in Australia.  In Europe, we have established distributor partnerships in the United Kingdom, Spain, Portugal, Holland, Finland, Belgium, Denmark, Germany, Sweden, Switzerland, Turkey, Austria, Italy and Norway.  Our team of clinical trainers and distribution managers continue to oversee the sales efforts and professional education programs of our European distributors.  We will continue to focus our efforts in Europe on training physicians, adding additional distributors, and obtaining reimbursement approval.

          Since 2001, we have increased investment in manufacturing in order to increase production volumes and improve yields.  Our manufacturing group continues to make progress in those areas.  We expect our current facility to be sufficient to meet our in-house manufacturing needs through 2003.

          Future revenues and results of operations may fluctuate significantly from quarter to quarter and will depend upon, among other factors, the extent to which Essure gains market acceptance, actions relating to regulatory and reimbursement matters, the long-term clinical results of our ongoing clinical trials, the ability to protect our intellectual property rights, the ability to attract marketing partners, the rate at which we establish our domestic and international distribution network, the ability to scale up our commercial manufacturing capabilities and the introduction of competitive products.  For more information, please read “Risk Factors” below.

Results of Operations – Three and Nine Months Ended September 30, 2002 and 2001

          Net sales were $481,000 for the three months ended September 30, 2002 as compared with $123,000 in the same period last year.  Net sales for the nine months ended September 30, 2002 were $1,185,000 as compared with $286,000 for the same prior year period.  The increase is the result of our continuing efforts in expanding and penetrating various markets for Essure in Europe, Australia, Canada and Singapore.  The net sales for the third quarter of 2002 by country or region consisted approximately of 43% to Australia and 57% to Europe compared with 68% to Australia and 28% to Singapore for the same period last year.  For the three months ended September 30, 2002, three distributors accounted for 43%, 24% and 11% of our net sales; while for the same period last year, one distributor accounted for 28% of our net sales.  At September 30, 2002, three distributors accounted for 31%, 29% and 14% of our outstanding accounts receivable.  At September 30, 2001, one distributor and one customer represented 24% and 12% of our outstanding accounts receivable.

          Cost of sales and start-up manufacturing costs for the three and nine months ended September 30, 2002 were $845,000 and $2,484,000, respectively, as compared with $537,000 and $1,183,000, for the same prior year periods, respectively.  The increase represented continued investment in manufacturing capabilities in preparation for higher volume commercial manufacturing, and increased cost of sales due to higher sales volume.

          Research and development (“R&D”) expenses were $2,170,000 and $6,500,000 for the three and nine months ended September 30, 2002, respectively, as compared with $1,953,000 and $5,818,000 for the same periods in the prior year, respectively.  The increase for the nine-month periods was primarily due to additional expenditures associated with regulatory and clinical affairs pertaining to the PMA filing.

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          Selling, general and administrative (“SG&A”) expenses were $5,972,000 and $13,207,000 for the three months and nine months ended September 30, 2002, respectively, as compared to $2,234,000 and $6,631,000 for the same periods in the prior year, respectively.  The increase was primarily the result of additional expenditures incurred in preparation for the commercialization of Essure in the U.S., coupled with continuing marketing and distributorship activities in Europe and support of on-going commercial sales and marketing activities in Australia.

          Other expenses of $314,000 for the nine months ended September 30, 2002 were related to a one-time settlement charge in connection with a 1997 distribution agreement related to our discontinued products and a foreign currency translation loss. 

          Interest and other income were $359,000 and $661,000 for the three months and nine months ended September 30, 2002, respectively, as compared with $143,000 and $545,000 for the same periods in the prior year, respectively.  The increase was due to a higher average cash balance from the completion of the follow-on public offering in June and subsequent exercise of the over-allotment option by the underwriters in July.

          We have experienced significant operating losses since inception and, as of September 30, 2002, had an accumulated deficit of $105,900,000. We expect our operating losses to continue at least through 2003 as we initiate commercialization of Essure in the U.S., continue to expend substantial resources related to increasing manufacturing capabilities and reducing production costs of Essure, and complete our long-term post-approval trial for Essure. 

Liquidity and Capital Resources

          As of September 30, 2002, cash, cash equivalents, short-term investments and restricted cash were $80.6 million, compared with $33.8 million at December 31, 2001.  The increase was due to the receipt of approximately $68.8 million of net proceeds from a follow-on public offering of 4.6 million shares of common stock at $16.00 per share and $0.8 million from the exercise of stock options, offset by $21.3 million of cash used in operating activities and $1.6 million of cash used in capital expenditures.

          Net cash used in operating activities was $21.3 million for the nine months ended September 30, 2002 as compared with $14.1 million for the same period in the prior year.  The increase was primarily attributable to our operating net loss, increased activities in sales and marketing in preparation for commercialization of Essure in the U.S., scale up of our manufacturing and quality operations in order to transition to a higher volume commercial manufacturing operation and continued activity in regulatory and clinical affairs.

          Net cash used in investing activities was $4.6 million for the nine months ended September 30, 2002, which represents $3.0 million of net purchases of short-term investments and $1.6 million of expenditures in capital equipment.  In the same period in the prior year, net cash provided by investing activities was $1.6 million, which consisted of $2.5 million of net cash provided by maturity of short-term investments, offset by $0.9 million of cash used for capital expenditures.       

          Net cash provided by financing activities was $69.6 million for the nine months ended September 30, 2002, which represents net proceeds of $66.8 million received from the follow-on public offering completed in June 2002, $2.0 million from the exercise of the over-allotment option in July 2002 and $0.8 million from the exercise of stock options.  Net cash provided by financing activities was $11.4

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million for the same period in the prior year due to the net proceeds received in a private placement completed in April 2001.

          We estimate that our existing capital resources will be sufficient to meet our cash requirements for more than the next twelve months.  Our future liquidity and capital requirements will depend upon numerous factors, including the rate of adoption of Essure by doctors and patients; resources devoted to establish sales and marketing and distribution capabilities; status of medical insurance coverage for Essure and resources devoted to improve the cost of manufacturing on a commercial scale.  Accordingly, we may require additional financing and therefore, may in the future seek to raise additional funds through bank facilities, debt or equity offerings or other sources of capital.  Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants.  Additional funding may not be available when needed or on terms acceptable to us.  If we are unable to obtain additional capital, we may be required to delay, reduce the scope of or eliminate our research and development programs or reduce our selling and marketing activities.  We expect to have negative cash flow from operations through at least 2003. 

Recent Accounting Pronouncements

          In April 2002, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards No. 145 (“SFAS 145”), “Rescission of FASB Statements No. 4, 44 and 64, Amendment of FASB Statement No. 13, and Technical Corrections,” which is effective for fiscal years beginning after May 15, 2002.  Under SFAS 145, gains and losses from the extinguishment of debt should be classified as extraordinary items only if they meet the criteria of Accounting Principles Board Opinion No. 30.  SFAS 145 also addresses financial accounting and reporting for capital leases that are modified in such a way as to give rise to a new agreement classified as an operating lease.  The Company believes that the adoption of SFAS 145 will not have a material impact on the consolidated financial position or results of the operations of the Company.

          In June 2002, the FASB issued Statement of Financial Accounting Standards No. 146 (“SFAS 146”), “Accounting for Costs Associated with Exit or Disposal Activities,” which is effective for exit or disposal activities initiated after December 31, 2002.  SFAS 146 nullifies Emerging Issues Task Force Issue No. 94-3, “Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring).”  Under SFAS 146, a liability is required to be recognized for a cost associated with an exit or disposal activity when the liability is incurred.  SFAS 146 applies to costs associated with an exit activity that does not involve an entity newly acquired in a business combination or with a retirement or disposal activity covered by FASB Statements No. 143, “Accounting for Asset Retirement Obligations,” and No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets”.  The Company believes that the adoption of SFAS 146 will not have a material impact on the consolidated financial position or results of the operations of the Company.

Risk Factors

          In addition to the other information in this Form 10-Q, the following factors should be considered carefully in evaluating Conceptus and our business.  This Form 10-Q contains forward-looking statements that involve risks and uncertainties.  Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below and elsewhere in this Form 10-Q.

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          We have a limited history of operation and have incurred significant operating losses since our inception. We expect to incur significant operating losses for the foreseeable future and we may never achieve or maintain profitability.

          We have a limited history of operation and have incurred significant operating losses since our inception in 1992, including operating losses of $21.0 million in the nine months ended September 30, 2002, $18.8 million in 2001, $15.8 million in 2000, and $8.0 million in 1999. We expect to continue to incur significant operating expenses and net losses as we begin to expand sales and marketing efforts in the United States. Our net losses may continue to increase until sufficient revenues can be generated to offset these expenses. We may not be able to generate these revenues, and we may never achieve profitability. Our failure to achieve and sustain profitability would negatively impact the market price of our common stock.

          If our product fails to gain market acceptance, our business will suffer.

          We are attempting to introduce a novel product into the contraception market, which is dominated by procedures that are well established among physicians and patients and are routinely taught to new physicians. As a result, we believe that recommendations and endorsements by physicians will be essential for market acceptance of our product.  We do not know whether physicians and patients will accept our product or whether we will be able to obtain their recommendations or endorsements.  We believe that physicians will not use a product unless they determine, based on clinical data and other factors, that it is an attractive alternative to other means of contraception and that it offers clinical utility in a cost-effective manner. Physicians are traditionally slow to adopt new products and treatment practices, partly because of perceived liability risks. If Essure does not achieve significant market acceptance among physicians, patients and healthcare payors, even if reimbursement and necessary international and U.S. regulatory approvals are obtained, we may never achieve significant revenues or profitability.

          Government or third party reimbursement for Essure may not be available or may be inadequate, which would limit our future product revenues and delay or prevent our profitability.

          Market acceptance of Essure in the U.S. and in international markets will depend in part upon the availability of reimbursement within prevailing healthcare payment systems. Reimbursement systems in international markets vary significantly by country and sometimes by region, and reimbursement approvals must be obtained on a country-by-country basis. Many international markets have government-managed health care systems that determine reimbursement for new devices and procedures. In most markets, there are private insurance systems as well as government-managed systems. Regardless of the type of reimbursement system, we believe that physician advocacy of our product will be required to obtain reimbursement. Availability of reimbursement will depend, at least in part, on the clinical and cost effectiveness of our product. We do not know whether reimbursement for our product will be available in the U.S. or in international markets under either government or private reimbursement systems, or whether physicians will support and advocate reimbursement for use of our systems for all indications intended by us. Large-scale market acceptance of Essure will depend on the availability and level of reimbursement in the U.S. and targeted international markets. We may be unable to obtain or maintain reimbursement in any country within a particular time, for a particular amount, or at all, which would limit our future product revenues and delay or prevent our profitability.

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          If the effectiveness and safety of our product are not supported by long-term data, we may not achieve market acceptance and we could be subject to liability.

          The Pivotal trial of Essure was designed to support a PMA application and to have four years of post-market follow-up.  In addition, patients in the Phase II study will be followed to five years. The long-term results of using Essure will not be available for several years. If long-term patient studies or clinical experience indicate that Essure is less effective or less safe than our current data suggest, we may not achieve market acceptance and/or we could be subject to significant liability.

          We may not maintain regulatory approvals for Essure, our only product, which would delay or prevent us from generating product revenues, and would harm our business and force us to curtail or cease operations.

          Numerous government authorities, both in the U.S. and internationally, regulate the manufacture and sale of medical devices, including Essure. In the U.S., the principal regulatory authorities are the FDA and corresponding state agencies, such as the California Department of Health Services. The process of obtaining and maintaining required regulatory clearances is lengthy, expensive and uncertain.

          The FDA requires companies that wish to market a new medical device or an existing medical device for use for a new indication to obtain either FDA clearance of a pre-market notification under Section 510(k) of the Federal Food, Drug, and Cosmetic Act or FDA approval of a PMA application prior to the introduction of the product into the market. The FDA has required us to submit a PMA application to obtain approval to market Essure, which is a more time consuming and costly process than obtaining 510(k) clearance.  We have received FDA approval to market Essure in the United States, the loss of which or our failure to comply with existing or future regulatory requirements could delay or prevent us from generating product revenues.

          Sales of medical devices outside of the U.S. are subject to international regulatory requirements that vary widely from country to country. The time required to obtain clearance required by foreign countries may be longer or shorter than that required for FDA clearance, and requirements for licensing may differ significantly from FDA requirements. Many countries in which we currently market or intend to market Essure either do not currently regulate medical devices or have minimal registration requirements; however, these countries may develop more extensive regulations in the future which could delay or prevent us from marketing Essure in these countries.

          The FDA and certain foreign regulatory authorities impose numerous requirements with which medical device manufacturers must comply in order to maintain regulatory approvals. FDA enforcement policy strictly prohibits the promotion of approved medical devices for uses other than those for which the device is specifically approved by the FDA. We will be required to adhere to applicable FDA regulations, such as the Quality System Regulation, and similar regulations in other countries, which include testing, control and documentation requirements. Ongoing compliance with the Quality System Regulation and other applicable regulatory requirements will be monitored through periodic inspections by federal and state agencies, including the FDA and the California Department of Health Services, and by comparable agencies in other countries. If we fail to comply with applicable regulatory requirements, we may be subject to, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to grant pre-market clearance or pre-market approval for devices, withdrawal of approvals and criminal prosecution, any of which could negatively impact our business.

          Our intellectual property rights may not provide meaningful commercial protection for our product, which could enable third parties to use our technology, or very similar technology, and could impair our ability to compete in the market.

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          We rely on patent, copyright, trade secret and trademark laws to limit the ability of others to compete with us using the same or similar technology in the U.S. and other countries. However, as described below, these laws afford only limited protection and may not adequately protect our rights to the extent necessary to sustain any competitive advantage we may have. The laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the U.S., and many companies have encountered significant problems in protecting their proprietary rights abroad. These problems can be caused by the absence of rules and methods for defending intellectual property rights.

          We will be able to protect our technology from unauthorized use by third parties only to the extent that they are covered by valid and enforceable patents or are effectively maintained as trade secrets. The patent positions of companies developing medical devices, including our patent position, generally are uncertain and involve complex legal and factual questions concerning the enforceability of such patents against alleged infringement. Recent judicial decisions have established new case law and a reinterpretation of previous patent case law, and consequently we cannot assure you that historical legal standards surrounding the questions of infringement and validity will be applied in future cases. In addition, legislation may be pending in Congress that, if enacted in its present form, may limit the ability of medical device manufacturers in the future to obtain patents on surgical and medical procedures that are not performed by, or as a part of, devices or compositions that are themselves patentable. Our ability to protect our proprietary methods and procedures may be compromised by the enactment of this legislation or any other limitation or reduction in the patentability of medical and surgical methods and procedures. Changes in either the patent laws or in interpretations of patent laws in the U.S. and other countries may therefore diminish the value of our intellectual property.

          We own, or control through licenses, a variety of issued patents and pending patent applications. However, the patents on which we rely may be challenged and invalidated, and our patent applications may not result in issued patents. Moreover, our patents and patent applications may not be sufficiently broad to prevent others from practicing our technologies or from developing competing products. We also face the risk that others may independently develop similar or alternative technologies or design around our patented technologies.

          We have taken security measures to protect our proprietary information, especially proprietary information that is not covered by patents or patent applications. These measures, however, may not provide adequate protection of our trade secrets or other proprietary information. We seek to protect our proprietary information by entering into confidentiality agreements with employees, collaborators and consultants. Nevertheless, employees, collaborators or consultants could still disclose our proprietary information and we may not be able to protect our trade secrets in a meaningful way. If we lose any employees we may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by those former employees despite the existence of a nondisclosure and confidentiality agreement and other contractual restrictions designed/intended to protect our proprietary technology. In addition, others may independently develop substantially equivalent proprietary information or techniques or otherwise gain access to our trade secrets.

          Our ability to compete effectively will depend substantially on our ability to develop and maintain proprietary aspects of our technology. Our issued patents, any future patents that may be issued as a result of our U.S. or foreign patent applications, or the patents under which we have license rights may not offer any degree of protection against competitive products. Any patents that may be issued or licensed to us or any of our patent applications could be challenged, invalidated or circumvented in the future.

          If we cannot operate our business without infringing third-party intellectual property rights, our prospects will suffer.

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          Our success will also depend on our ability to operate without infringing or misappropriating the proprietary rights of others. We may be exposed to future litigation by third parties based on claims that our product infringes the intellectual property rights of others. There are numerous issued patents in the medical device industry and, as described in the next risk factor, the validity and breadth of medical device patents involve complex legal and factual questions for which important legal principles remain unresolved. Our competitors may assert that our product and the methods we employ may be covered by U.S. or foreign patents held by them. In addition, because patent applications can take many years to issue, there may be currently pending patent applications of which we are unaware that may later result in issued patents that our product may infringe. There could also be existing patents of which we are unaware that our product may inadvertently infringe. If we lose a patent infringement lawsuit, we could be prevented from selling our product unless we can obtain a license to use technology or ideas covered by that patent or are able to redesign the product to avoid infringement. A license may not be available to us on terms acceptable to us, or at all, and we may not be able to redesign our product to avoid any infringement. If we are not successful in obtaining a license or redesigning our product, we may be unable to sell our product and our business would suffer.

          We are currently and may in the future be a party to patent litigation, which could be expensive and divert our management’s attention.

          The medical device industry has been characterized by extensive litigation regarding patents and other intellectual property rights, and companies in the industry have used intellectual property litigation to gain a competitive advantage. We may become a party to patent infringement claims and litigation or interference proceedings declared by the U.S. Patent and Trademark Office, or PTO, to determine the priority of inventions. The defense and prosecution of these matters are both costly and time consuming. We may need to commence proceedings against others to enforce our patents, to protect our trade secrets or know-how or to determine the enforceability, scope and validity of the proprietary rights of others. These proceedings would result in substantial expense to us and significant diversion of effort by our technical and management personnel.

          A third party, Ovion, Inc., has brought to our attention two patents and certain claims from a pending patent application owned by it. Ovion is a small company formed by William Tremulis and Jeffrey Callister. Mr. Tremulis interviewed with our company for employment and thereafter filed patent applications containing subject matter that appears similar to the Essure micro-insert. Ovion has indicated it believes that the claims of its patent and application cover Essure and its use. Because we believe that some or all of Ovion’s claims should be included within our own patents, we have requested that the PTO to declare at least one interference. An interference is a proceeding within the PTO to determine which party was the first to invent, and which party is thereby entitled to ownership of, the claims. We believe that we filed our patent applications for our product before Ovion filed the application that issued as its patent, and that we are entitled to any patentable claims now appearing in Ovion’s patent that cover Essure. We do not know whether the PTO will declare an interference, whether we invented our product prior to Ovion’s date of invention, or whether we will prevail in an interference proceeding if it is declared by the PTO. If the PTO refuses to declare an interference, or if Ovion’s claims are upheld in the interference proceeding, Ovion may be able to assert its patent successfully against us. We also filed a lawsuit in United States District Court for the Northern District of California on April 23, 2002 against Ovion. The lawsuit seeks a declaration that Essure does not infringe Ovion’s patent (U.S. Patent No. 6,096,052) and that the patent is invalid and unenforceable due to Ovion’s inequitable conduct before the PTO.  During an October 28, 2002 hearing before the Court, Ovion stated that it does not intend to charge Conceptus with infringement of U.S. Patent 6,096,052.  However, on August 13, 2002, Ovion has filed a separate action, in the same court, charging Conceptus with infringement of a related patent, United States Patent No. 6,432,116 entitled “Occluding Device and

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Method of Use.”  Conceptus has denied infringement and filed a Declaratory Judgment counterclaim, seeking a declaration that U.S. Patent No. 6,432,116 is not infringed, invalid and unenforceable. 

          An adverse determination in litigation or interference proceedings to which we are or may become a party could subject us to significant liabilities to third parties or require us to seek licenses from third parties. Although patent and intellectual property disputes in the medical device area have often been settled through licensing or similar arrangements, costs associated with such arrangements may be substantial and could include ongoing royalties. We may be unable to obtain necessary licenses on satisfactory terms, if at all. Adverse determinations in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling Essure.

          One of the patents included in our license from Target Therapeutics, a division of Boston Scientific Corporation, has been the subject of reexamination proceedings in the PTO and an infringement lawsuit by Target Therapeutics. The patent is directed to variable stiffness catheters for use with guidewires, as might be used in our future products. Although the PTO reaffirmed the patent with amended claims and the lawsuit was settled, the patent could be challenged or invalidated in the future. If this patent is invalidated, our ability to prevent others from using this proprietary technology would be compromised.

          We have limited sales and marketing experience and minimal distribution capabilities, and if we are unable to develop our sales and marketing capabilities or enter into appropriate distribution agreements, we may be unsuccessful in commercializing Essure.

          In order to market, sell and distribute Essure, we will need to continue to develop a sales force and marketing group with relevant experience and enter into additional arrangements with third parties to distribute Essure. Developing a marketing and sales force is expensive and time consuming and could delay our product launch. If we fail to establish adequate marketing and sales capabilities or enter into successful distribution arrangements with third parties, we may be unable to commercialize Essure successfully.

          If we fail to manage our expansion, our business could be impaired.

          Our number of employees has increased to 169 on September 30, 2002 from 98 on September 30, 2001. The growth that we have experienced, and in the future may experience, provides challenges to our organization. Although we have no current plans to do so, we may in the future acquire one or more technologies, products or companies that complement our business. We may not be able to effectively integrate these into our business. If we fail to manage our growth and expansion, our business could be impaired.

          We have limited experience in manufacturing Essure in commercial quantities.

          If we are successful in marketing Essure, we plan to increase internal manufacturing operations as well as to use third-party manufacturers to manufacture certain processes and assemblies of the product. We have identified candidates that we believe could adequately produce Essure with the appropriate quality and sufficient volumes. However, third-party manufacturers often encounter difficulties in scaling up production of new products, including problems involving production yields, quality control and assurance, component supply and shortages of qualified personnel, and compliance with FDA or other health authority requirements. We and/or our future third-party manufacturers may encounter manufacturing difficulties, which could prevent or delay commercialization of Essure.

          We depend upon sole source suppliers and have no contractual arrangements.

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          We purchase both raw materials used in our product and finished goods from various suppliers, and we rely on single sources for some items, including the delivery catheter tubing and polyester fiber. We do not have formal supply contracts with several key vendors and, accordingly, these firms may not continue to supply us with raw materials or finished goods in sufficient quantities, or at all. Delays associated with any future raw materials or finished goods shortages could delay commercialization of Essure, particularly as we scale up our manufacturing activities in support of U.S. and international commercial sales of Essure. 

          Health care reform may limit our return on our product.

          The levels of revenue and profitability of medical device companies may be affected by the efforts of government and third party payors to contain or reduce the costs of health care through various means. In the U.S., there have been, and we expect that there will continue to be, a number of federal, state and private proposals to control health care costs. These proposals may contain measures intended to control public and private spending on health care as well as to provide universal public access to the health care system. If enacted, these proposals may result in a substantial restructuring of the health care delivery system. Significant changes in the U.S. health care system are likely to have a substantial impact over time on the manner in which we conduct our business and could have a material adverse effect on our business, financial condition and results of operations.

          We may be exposed to product liability claims, and we have only limited insurance coverage.

          The manufacture and sale of medical products involve an inherent risk of exposure to product liability claims and product recalls. Although we have not experienced any product liability claims to date, we cannot assure you that we will be able to avoid significant product liability claims and potential related adverse publicity. We currently maintain product liability insurance with coverage limits of $10 million per occurrence and an annual aggregate maximum of $10 million, which we believe is comparable to that maintained by other companies of similar size serving similar markets. However, we cannot assure you that product liability claims in connection with clinical trials or sales of Essure will not exceed such insurance coverage limits or that such insurance will continue to be available on commercially reasonable terms, or at all. Insurance is expensive and in the future may not be available on acceptable terms, if at all. A successful product liability claim or series of claims brought against us in excess of our insurance coverage, or a recall of our product, could cause our stock price to fall.

          We may not be able to attract and retain additional key management, sales and marketing and technical personnel or we may lose existing key management, sales and marketing or technical personnel, which may delay our development and marketing efforts.

          We depend on a number of key management, sales and marketing and technical personnel. The loss of the services of one or more key employees could delay the achievement of our development and marketing objectives. Our success will also depend on our ability to attract and retain additional highly qualified management, sales and marketing and technical personnel to meet our growth goals. We face intense competition for qualified personnel, many of whom are often subject to competing employment offers, and we do not know whether we will be able to attract and retain such personnel.

          We face intense competition, and if we are unable to compete effectively, demand for Essure may be reduced.

          The medical device industry is highly competitive and is characterized by rapid and significant technological change. The length of time required for product development and regulatory approval plays

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an important role in a company’s competitive position. As we commercialize Essure, we expect to compete with:

          If we experience difficulties in our sales and operations, our financial condition will be harmed.

          Our financial condition is highly dependent on the sale of Essure in U.S., Australia, Europe and other countries. If we experience difficulties in our domestic and international sales and operations, our business will suffer and our financial condition will be harmed. Our domestic and/or international operations and sales are subject to a number of risks, including:

          Our future liquidity and capital requirements are uncertain.

          As we commercialize Essure on a wide-scale basis, we may require additional financing and therefore may in the future seek to raise additional funds through bank facilities, debt or equity offerings or other sources of capital. Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. Additional funding may not be available when needed or on terms acceptable to us. If we are unable to obtain additional capital, we may be required to delay, reduce the scope of or eliminate our research and development programs or reduce our selling and marketing activities. We expect to have negative cash flows from operations through at least 2003. Our future liquidity and capital requirements will depend upon many factors, including, among others:

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          Our future quarterly results may fluctuate.

          Our future revenues and results of operations may fluctuate significantly from quarter to quarter and will depend upon, among other factors:

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Item 3.  Quantitative and Qualitative Disclosures About Market Risk

              Our cash balances in excess of short-term operating needs are invested in money market funds, highly liquid short-term government securities and high quality commercial paper.  Due to the high quality nature of these instruments, we believe these financial instruments are exposed to a low level of credit risk.

              As of September 30, 2002, a fluctuation in exchange rate of 10% in the foreign currencies to which we are exposed would not have a material impact on our results of operations or financial condition.  However, as we expand our international operations, exposure to foreign currency fluctuations will increase.

Item 4.  Controls and Procedures

              The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in the Company’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.  In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

              Within 90 days prior to the date of this report, the Company carried out an evaluation, under the supervision and with the participation of the Company’s management, including the Company’s Chief Executive Officer and the Company’s Chief Financial Officer, of the effectiveness of the design and operation of the Company’s disclosure controls and procedures.  Based on the foregoing, the Company’s Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were effective.

              There have been no significant changes in the Company’s internal controls or in other factors that could significantly affect the internal controls subsequent to the date the Company completed its evaluation.

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PART II.  OTHER INFORMATION

Item 1.  Legal Proceedings

              We have filed an action against Ovion, Inc., a development-stage, privately held company, in the United States District Court, Northern District of California.  We are pursuing a Declaratory Judgment of Patent Non-Infringement, Invalidity and Unenforceability against Ovion’s United States Patent No. 6,096,052 entitled “Occluding Device and Method of Use.”  During a recent hearing before the Court, Ovion stated that it does not intend to charge Conceptus with infringement of U.S. Patent No. 6,096,052.  However, on August 13, 2002, Ovion has filed a separate action, in the same court, charging Conceptus with infringement of a related patent, United States Patent No. 6,432,116 entitled “Occluding Device and Method of Use.”  Conceptus has denied infringement and filed a Declaratory Judgment counterclaim, seeking a declaration that U.S. Patent No. 6,432,116 is not infringed, invalid and unenforceable.

Item 2.  Changes in Securities and Use of Proceeds

              None.

Item 3.  Defaults upon Senior Securities

              None.

Item 4.  Submission of Matters to a Vote of Security Holders

              None.

Item 5.  Other Information

              None.

Item 6.  Exhibits and Reports on Form 8-K

              (a)   Exhibits.

                      None.

              (b)   Reports on Form 8-K.

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SIGNATURE

               Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

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CERTIFICATIONS

I, Steven Bacich, certify that:

1.  I have reviewed this quarterly report on Form 10-Q of Conceptus, Inc., a Delaware corporation;

2.  Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

3.  Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

4.  The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

5.  The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

6.  The registrant’s other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

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I, Glen K. Furuta, certify that:

1.  I have reviewed this quarterly report on Form 10-Q of Conceptus, Inc., a Delaware corporation;

2.  Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

3.  Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

4.  The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

5.  The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

6.  The registrant’s other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

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