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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2010

 

OR

 

o         TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from               to              .

Commission File Number: 0-27596

 

CONCEPTUS, INC.

(Exact name of Registrant as specified in its charter)

 

Delaware

 

94-3170244

(State or other jurisdiction of

 

(I.R.S. Employer

incorporation or organization)

 

Identification No.)

 

331 East Evelyn

Mountain View, CA 94041

(Address of Principal Executive Offices) (Zip Code)

 

(650) 962-4000

(Registrant’s Telephone Number, Including Area Code)

 

 

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

 

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 the past 90 days. Yes  x    No  o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  o    No  o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer o

 

Accelerated filer x

 

 

 

Non-accelerated filer o

 

Smaller reporting company o

(Do not check if a smaller reporting company)

 

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of Exchange Act). Yes  o   No  x

 

There were 31,032,306 shares of Registrant’s Common Stock issued and outstanding as of May 1, 2010.

 

 

 



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CONCEPTUS, INC.

 

Form 10-Q for the Quarter Ended March 31, 2010

 

 

 

 

 

Page

Part I.

Financial Information

 

 

 

 

 

 

 

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

 

 

 

 

 

 

 

 

 

a) Condensed Consolidated Balance Sheets as of March 31, 2010 and December 31, 2009

 

3

 

 

b) Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2010 and 2009

 

4

 

 

c) Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2010 and 2009

 

5

 

 

d) Notes to Condensed Consolidated Financial Statements

 

6

 

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

19

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

27

 

 

 

 

 

Item 4.

Controls and Procedures

 

28

 

 

 

 

 

Part II.

Other Information

 

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

29

 

 

 

 

 

Item 1A.

Risk Factors

 

29

 

 

 

 

 

Item 6.

Exhibits

 

33

 

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PART I. FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements.

 

Conceptus, Inc.

 

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

 

 

March 31,

 

December 31,

 

 

 

2010

 

2009

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

29,544

 

$

61,658

 

Short-term investments

 

52,642

 

40,626

 

Put option

 

3,203

 

2,933

 

Accounts receivable, net

 

17,687

 

17,315

 

Inventories

 

5,123

 

4,908

 

Prepaids

 

3,316

 

1,897

 

Other current assets

 

2,088

 

1,540

 

Total current assets

 

113,603

 

130,877

 

 

 

 

 

 

 

Property and equipment, net

 

9,970

 

9,782

 

Debt issuance costs, net

 

871

 

987

 

Intangible assets, net

 

26,637

 

27,687

 

Long-term investments

 

13,903

 

 

Restricted cash

 

362

 

360

 

Goodwill

 

16,257

 

17,318

 

Other assets

 

119

 

128

 

Total assets

 

$

181,722

 

$

187,139

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

5,390

 

$

5,878

 

Accrued compensation

 

5,767

 

8,208

 

Line of credit

 

25,670

 

29,240

 

Other accrued liabilities

 

3,968

 

4,012

 

Total current liabilities

 

40,795

 

47,338

 

 

 

 

 

 

 

Deferred tax liability

 

1,155

 

1,277

 

Notes payable

 

77,615

 

76,531

 

Other accrued liabilities

 

1,121

 

1,135

 

Total liabilities

 

120,686

 

126,281

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock and additional paid-in capital

 

299,833

 

296,191

 

Accumulated other comprehensive loss

 

(2,106

)

(993

)

Accumulated deficit

 

(236,691

)

(234,340

)

Treasury stock, 77,863 shares, at cost

 

 

 

Total stockholders’ equity

 

61,036

 

60,858

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

181,722

 

$

187,139

 

 

The accompanying notes are an integral 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)

 

 

 

Three months ended

 

 

 

March 31,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

Net sales

 

$

33,358

 

$

27,151

 

Cost of goods sold

 

6,391

 

5,756

 

Gross profit

 

26,967

 

21,395

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

Research and development

 

1,746

 

1,407

 

Selling, general and administrative

 

25,979

 

22,570

 

Total operating expenses

 

27,725

 

23,977

 

 

 

 

 

 

 

Operating loss

 

(758

)

(2,582

)

 

 

 

 

 

 

Interest income

 

273

 

356

 

Interest expense

 

(1,756

)

(1,718

)

Other income (expense), net

 

24

 

(250

)

Total interest income and expense and other income (expense), net

 

(1,459

)

(1,612

)

 

 

 

 

 

 

Loss before provision for income taxes

 

(2,217

)

(4,194

)

 

 

 

 

 

 

Provision for income taxes

 

134

 

141

 

Net loss

 

$

(2,351

)

$

(4,335

)

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.08

)

$

(0.14

)

 

 

 

 

 

 

Weighted-average shares used in computing basic and diluted net loss per share

 

30,930

 

30,438

 

 

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)

 

 

 

Three months ended

 

 

 

March 31,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

Cash flows from operating activities

 

 

 

 

 

Net loss

 

$

(2,351

)

$

(4,335

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization of property and equipment

 

1,097

 

1,013

 

Amortization of debt issuance costs

 

116

 

116

 

Accretion of notes payable

 

1,084

 

1,025

 

Amortization of intangible assets

 

819

 

180

 

Amortization and accretion of discount and premium on investments

 

126

 

 

Loss (gain) on put option

 

(270

)

177

 

Loss (gain) on trading securities

 

274

 

(155

)

Stock-based compensation expense

 

1,729

 

1,347

 

Loss (gain) on disposal of property and equipment

 

11

 

(12

)

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(727

)

(459

)

Inventories

 

(155

)

1,014

 

Other current assets

 

(2,006

)

(375

)

Accounts payable

 

92

 

1,195

 

Accrued compensation

 

(2,279

)

(1,321

)

Other accrued and long term liabilities

 

(42

)

(115

)

Net cash used in operating activities

 

(2,482

)

(705

)

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

Sales and maturities of investments

 

5,175

 

 

Purchase of investments

 

(31,539

)

 

Capital expenditures

 

(1,393

)

(848

)

Net cash used in investing activities

 

(27,757

)

(848

)

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

Proceeds from line of credit

 

1,828

 

1,067

 

Repayment of line of credit

 

(5,398

)

(97

)

Proceeds from issuance of common stock

 

1,843

 

225

 

Net cash (used in) provided by financing activities

 

(1,727

)

1,195

 

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

(148

)

(121

)

 

 

 

 

 

 

Net decrease in cash and cash equivalents

 

(32,114

)

(479

)

Cash and cash equivalents at beginning of the period

 

61,658

 

54,720

 

Cash and cash equivalents at end of the period

 

$

29,544

 

$

54,241

 

 

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

 

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Conceptus, Inc.

 

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 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 for complete financial statements. In the opinion of management, all adjustments, consisting only of normal recurring adjustments, considered necessary for a fair statement have been included.

 

The condensed consolidated balance sheet as of December 31, 2009 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 for complete financial statements. This financial data should be read in conjunction with the audited consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2009.  The results of operations for the three months ended March 31, 2010 may not necessarily be indicative of the operating results for the full 2010 fiscal year or any other future interim periods.

 

We have a limited history of operations with the Essure system and since our inception in 1992, we have incurred cumulative operating losses until we experienced our first operating profit in Fiscal 2009.  In December 2006, we filed a Registration Statement on Form S-3, through which we may sell from time to time any combination of debt securities, common stock, preferred stock and warrants, in one or more offerings, with an initial offering price not to exceed $150,000,000. In February 2007, we issued an aggregate principal amount of $86,250,000 of our 2.25% convertible senior notes due 2027.  The notes can be convertible into shares within certain time periods, without having to meet the other contingent convertibility conditions as outlined in Note 9 — Convertible Senior Notes.  The first period is the window between December 15, 2011 and February 15, 2010.  The second period is anytime after February 15, 2025 up until maturity at February 15, 2027.   If the notes are converted, then upon conversion (“net shares settlement”), holders will receive cash and in certain circumstances, shares of our common stock based on an initial conversion rate, subject to adjustment, of 35.8616 shares per $1,000 principal amount of notes (which represents an initial conversion price of $27.89 per share). Upon conversion, a holder would receive cash up to the principal amount of the note and our common stock in respect of such note’s conversion value in excess of such principal amount. This net share settlement feature of the notes would reduce our liquidity, and we may not have sufficient funds to pay in full the cash obligation upon such conversion. In the future, depending upon a variety of factors, we may need 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 covenants that restrict us. 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 sales and marketing activities.

 

Recent Accounting Pronouncements

 

In January 2010, the FASB issued updated guidance related to fair value measurements and disclosures, which requires a reporting entity to disclose separately the amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and to describe the reasons for the transfers. In addition, in the reconciliation for fair value measurements using significant unobservable inputs, or Level 3, a reporting entity should disclose separately information about purchases, sales, issuances and settlements (that is, on a gross basis rather than one net number). The updated guidance also requires that and entity should provide fair value measurement disclosures for each class of assets and liabilities and disclosures about the valuation techniques and inputs used to measure fair value for both recurring and non-recurring fair value measurements for Level 2 and Level 3 fair value measurements. The updated guidance is effective for interim or annual financial reporting periods beginning after December 15, 2009, except for the disclosures about purchases, sales, issuances and settlements in the roll forward activity in Level 3 fair value measurements, which are effective for fiscal years beginning after December 15, 2010 and for interim periods within those fiscal years. We have adopted this guidance in the first quarter of 2010.  See Note 4 — Fair Value Measurement.

 

In February 2010, the FASB issued amended guidance on subsequent events. Under this amended guidance, SEC filers are no longer required to disclose the date through which subsequent events have been evaluated in originally issued and

 

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revised financial statements. We adopted this guidance in the first quarter of fiscal 2010 and the adoption did not have a material impact on our financial condition, results of operations, or cash flows.

 

2.     Summary of Significant Accounting Policies

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The primary estimates underlying our financial statements include the write-off of obsolete and slow moving inventory, allowance for doubtful accounts receivable, product warranty, the fair value of our investment portfolio, assumptions regarding variables used in calculating the fair value of our equity awards, impairment of goodwill, intangibles and other long-lived assets, income taxes and contingent liabilities. Actual results could differ from those estimates.

 

Principles of Consolidation

 

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated.

 

Functional Currency

 

On January 7, 2008, we acquired Conceptus SAS, which sells to customers throughout Europe.  Sales by Conceptus SAS are denominated in Euros. On December 15, 2008, we incorporated Conceptus Medical Limited (“CML”) as our United Kingdom subsidiary.  In preparing our condensed consolidated financial statements, we are required to translate the financial statements of Conceptus SAS and CML from the currency in which they keep their accounting records into U.S. Dollars.  Conceptus SAS and CML both maintain their accounting records in the functional currency which is also their local currency. The functional currency of CML is the British Pound and the functional currency of Conceptus SAS is the Euro.  The functional currency is determined based on management’s judgment and involves consideration of all relevant economic facts and circumstances affecting the subsidiary. Generally, the currency in which the subsidiary transacts a majority of its transactions, including billing, financing, payroll and other expenditures would be considered the functional currency, but any dependency upon the parent and the nature of the subsidiary’s operations must also be considered. Since the functional currency of Conceptus SAS and CML has been determined to be their local currency, any gain or loss associated with the translation of Conceptus SAS’s and CML’s financial statements into U.S. Dollars is included as a component of stockholders’ equity, in accumulated other comprehensive loss.  If in the future we determine that there has been a change in the functional currency of Conceptus SAS or CML from its local currency to the U.S. Dollar, any translation gains or losses arising after the date of change would be included within our statement of operations.

 

Goodwill and Other Intangible Assets

 

Goodwill represents the excess of the purchase price paid over the fair value of tangible and identifiable intangible net assets acquired in business combinations. We will perform an annual assessment during the fourth quarter of 2010 of our goodwill at the reporting unit level or earlier if an event occurs or circumstances change that would reduce the fair value of the reporting unit below its carrying amount. No impairment charges have been recorded as of March 31, 2010.

 

Other intangible assets include patents, customer relationships, license agreements and non-compete agreements. They are amortized using the straight-line method over their respective estimated useful lives.

 

Impairment of Long-Lived Assets

 

We account for the impairment of long-lived assets in accordance with ASC 350, Goodwill and Other.  We evaluate the carrying value of our long-lived assets, consisting primarily of our property and equipment, the patents acquired in connection with our purchase of the intellectual property assets from Ovion Inc, and intangible assets acquired in connection with our acquisition of Conceptus SAS, whenever certain events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable (see Note 5 — Goodwill and Intangible Assets).  Such events or circumstances include a prolonged industry downturn, a significant decline in our market value or significant reductions in projected future cash flows.

 

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Significant judgments and assumptions are required in the forecast of future operating results used in the preparation of the estimated future cash flows, including profit margins, long-term forecasts of the amounts and timing of overall market growth and our percentage of that market, groupings of assets, discount rates and terminal growth rates. In addition, significant estimates and assumptions are required in the determination of the fair value of our tangible long-lived assets, including replacement cost, economic obsolescence, and the value that could be realized in orderly liquidation. Changes in these estimates could have a material adverse effect on the assessment of our long-lived assets, thereby requiring us to write down the assets.

 

3.  Investments

 

As of March 31, 2010, we held $38.4 million (par value) in auction rate securities, or ARS, backed by federal and state student loans which are variable rate debt instruments and bear interest rates that reset approximately every 20-30 days. These ARS have a contractual maturity ranging from 2028 through 2047.

 

Our ARS are short-term debt instruments backed by student loans, a substantial portion of which are guaranteed by the United States government.  Prior to 2008, our ARS were highly liquid, using a Dutch auction process that resets the applicable interest rate at predetermined intervals, typically every 20-30 days, to provide liquidity at par.  We have experienced failed auctions since 2008 on most of our ARS.   The failures of these auctions do not affect the value of the collateral underlying the ARS, and we continue to earn and receive interest on our ARS at a pre-determined formula with spreads tied to particular interest rate indexes.

 

In November 2008, we accepted an offer from UBS AG, providing us with rights related to our ARS (the “Rights”).  The Rights permit us to require UBS to purchase our ARS at par value, which is defined as the price equal to the liquidation preference of the ARS plus accrued but unpaid dividends or interest, at any time during the period of June 2010 through July 2012.  Conversely, UBS has the right, in its discretion, to purchase or sell our ARS at any time until July 2012, so long as we receive payment at par value upon any sale or disposition.  We expect to sell our ARS under the Rights at par value.  However, if the Rights are not exercised before July 2012 they will expire and UBS will have no further rights or obligation to buy our ARS.  So long as we hold our ARS, they will continue to accrue interest as determined by the auction process or the terms of the ARS if the auction process fails.  We had settlements of our ARS in the three months ended March 31, 2010 of $5.2 million at full par value and recorded a loss of $0.3 million which represents the decrease in the fair value of the ARS.  The fair value of the ARS at March 31, 2010 is $35.2 million.

 

UBS’s obligations under the Rights are not secured by its assets and do not require UBS to obtain any financing to support its performance obligations under the Rights.  UBS has disclaimed any assurance that it will have sufficient financial resources to satisfy its obligations under the Rights.

 

We have accounted for the Rights as a freestanding financial instrument and elected to record the value of the Rights under the fair value option of ASC 825 Financial Instruments.  As a result of our election to record the Rights at fair value, unrealized gains and losses have been included in earnings.    We estimated the fair value of the Rights using the expected value that we will receive from UBS which was calculated as the difference between the anticipated recognized loss and par value of the ARS as of the option exercise date. This value was discounted by using a UBS credit default rate to account for the consideration of UBS credit risk. For the three months ended March 31, 2010, we recorded an additional gain of $0.3 million which represents the increase in the fair value of the put option.

 

Prior to accepting the UBS offer, we recorded our ARS as available-for-sale investments.  We recorded unrealized gains and losses on our available-for-sale securities, in accumulated other comprehensive income (loss) in the stockholders’ equity section of our balance sheets.  Such an unrealized loss did not change net income (loss) for the applicable accounting period.

 

In connection with our acceptance of the UBS offer in November 2008, resulting in our right to require UBS to purchase our ARS at par value beginning on June 2010, we transferred our ARS from available-for-sale to trading securities in accordance with ASC 320 Investments — Debt and Equity Securities.   The transfer to trading securities reflected our intent to exercise our put option during the third quarter of 2010.   Prior to our agreement with UBS, our intent was to hold our ARS until we realized the par value.

 

In November 2008, we entered into a revolving credit line agreement with UBS, payable on demand, in an amount equal to 75% of fair value of our auction rate securities at net no cost, meaning that the interest we pay on the credit line will not exceed the interest that we receive on the ARS that we have pledged as security for the credit line. Additionally, under the terms of the settlement agreement, if UBS is able to sell our ARS at par, proceeds would be utilized to first repay any

 

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outstanding balance under the revolving credit line. We are still able to sell the ARS, but in such a circumstance, if we sold at less than par value, we would not be entitled to recover the par value support from UBS.   See Note 10 — Credit Line.

 

As of March 31, 2010 we had short and long-term investments of $31.4 million recorded at fair value in addition to the $35.2 million of ARS.  Our investments consist of time deposits, U.S. treasury bills, U.S. government bonds and corporate bonds.  We will sell certain or all investments as needed to meet the cash flow needs of our business.  Hence our investments are classified as available-for-sale securities in accordance with ASC 320 Investments — Debt and Equity Securities.  Investments are classified as short-term or long-term based on the underlying investments maturity date.

 

The following table summarized our amortized cost, unrealized gains and loss, and the fair value of our available-for-sales investments, as of March 31, 2010 (in thousands):

 

 

 

Amortized

 

Unrealized

 

Unrealized

 

 

 

 

 

Cost

 

Gain

 

Loss

 

Fair Value

 

Investments:

 

 

 

 

 

 

 

 

 

Corporate bonds

 

$

19,670

 

$

6

 

$

(43

)

$

19,633

 

U.S. government bonds

 

6,510

 

3

 

(8

)

6,505

 

U.S. treasury bills

 

3,987

 

 

(1

)

3,986

 

Time deposits

 

1,245

 

 

(1

)

1,244

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

31,412

 

$

9

 

$

(53

)

$

31,368

 

 

 

 

 

 

 

 

 

 

 

Reported as:

 

 

 

 

 

 

 

 

 

Short-term investments

 

$

17,482

 

$

2

 

$

(19

)

$

17,465

 

Long-term investments

 

13,930

 

7

 

(34

)

13,903

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

31,412

 

$

9

 

$

(53

)

$

31,368

 

 

We had several investments that were in an unrealized loss position as of March 31, 2010.  We have determined that (i) we do not have the intent to sell any of these investments, and (ii) it is more likely than not that we will not be required to sell any of these investments before recovery of the entire amortized cost basis.  We review our investments to identify and evaluate investments that have an indication of possible impairment.  As of March 31, 2010 we anticipate that we will recover the entire carrying value of such investments and have determined that no other-than-temporary impairments associated with credit losses were required to be recognized during the three months ended March 31, 2010.

 

The following table presents our available-for-sale investments that are in an unrealized loss position as of March 31, 2010 (in thousands):

 

 

 

Less than 12 Months

 

12 Months or Greater

 

Total

 

 

 

Fair

 

Unrealized

 

Fair

 

Unrealized

 

Fair

 

Unrealized

 

 

 

Value

 

Loss

 

Value

 

Loss

 

Value

 

Loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate bonds

 

$

7,724

 

$

(17

)

$

7,474

 

$

(26

)

$

15,198

 

$

(43

)

U.S. treasury bills

 

3,987

 

(1

)

 

 

3,987

 

(1

)

U.S. government bonds

 

 

 

1,992

 

(8

)

1,992

 

(8

)

Time deposits

 

1,244

 

(1

)

 

 

1,244

 

(1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

12,955

 

$

(19

)

$

9,466

 

$

(34

)

$

22,421

 

$

(53

)

 

4.     Fair Value Measurements

 

On January 1, 2008, we adopted the methods of fair value as described in ASC 820 Fair Value Measurement and Disclosure (“ASC 820”) to value our financial assets and liabilities.  As defined in ASC 820, fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, ASC 820 establishes a

 

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fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:

 

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

 

Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.

 

Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

 

Fair value of Assets

 

Our cash and cash equivalents and investments, other than ARS, are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices, broker or dealer quotations, or alternative pricing sources with a reasonable level of price transparency. As of March 31, 2010, our Level 1 instruments were investments in money market funds, time deposits, U.S. treasury bills, U.S. government bonds and corporate bonds.

 

As a result of continued auction failures, quoted prices for our ARS did not exist as of March 31, 2010 and, accordingly, we concluded that Level 1 inputs were not available for these assets. Brokerage statements received from our broker/dealer that held our ARS included their estimated market value as of March 31, 2010. Our broker/dealer valued our ARS at 89% of par. We made inquiries relative to the measurements utilized to derive the estimated market values quoted on our brokerage statements, but the broker/dealer declined to provide detailed information relating to their valuation methodologies. Due to the lack of transparency into the methodologies used to determine the estimated market values, we concluded that estimated market values provided on our brokerage statements did not constitute valid inputs and thus we did not utilize them in measuring the fair value of these ARS as of March 31, 2010.

 

We determined that use of a valuation model was the best available technique for measuring the fair value of our ARS. We used a trinomial discount model weighting estimated future cash flows, quality of collateral and the probability of future successful auctions occurring. While our valuation model was based on both Level 2 (credit quality and interest rates) and Level 3 inputs, we determined that the Level 3 inputs were the most significant to the overall fair value measurement of these assets, particularly the estimates of expected periods of illiquidity. In determining a discount factor for each ARS, the model weights various factors, including assessments of credit quality, duration, insurance wraps, portfolio composition, discount rates, overall capital market liquidity and comparable securities, if any.

 

The put option is a free standing asset separate from the ARS, and represents our contractual right to require our broker, UBS, to purchase our ARS at par value during the period of June 2010 through July 2012.  The put option is classified as short-term because we intend to is to sell our ARS under the Rights at the inception of the Rights period in the third quarter of 2010.  See Note 3 — Investments.

 

Periodically, during the three months ended March 31, 2010 we entered into forward contracts to buy U.S dollars at fixed intervals in the retail market in an over-the-counter environment.  As of March 31, 2010, we had foreign currency forward contracts to sell 5.2 million Euros in exchange for $7.4 million maturing in April 2010 through July 2010.  As of March 31, 2010 these forward contracts are recorded at their fair value of $0.5 million in other current assets on our condensed consolidated balance sheet.  We have outstanding short-term intercompany receivables of $7.4 million as of March 31, 2010.  We expect the changes in the fair value of the intercompany receivables to be materially offset by the changes in the fair value of the forward contracts.

 

The purpose of these forward contracts is to minimize the risk associated with foreign exchange rate fluctuations.  We have developed a foreign currency exchange policy to govern our forward contracts.  These foreign currency contracts do not qualify as cash flow hedges and all changes in fair value are reported in earnings as part of other income and expenses.  We have not entered into any other types of derivative financial instruments for trading or speculative purpose.  Our foreign currency forward contracts valuation inputs are based on quoted prices and quoted pricing intervals from public data and do not involve management judgment.  Accordingly, we have classified our outstanding foreign currency forward contracts within Level 2 of the fair value hierarchy and have recorded the fair value of the contracts in other current assets on our condensed consolidated balance sheet as of March 31, 2010.

 

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Assets measured at fair value on a recurring basis at March 31, 2010 are as follows (in thousands):

 

 

 

 

 

Fair Value Measurements at Reporting Data

 

 

 

March 31

 

Quoted Price in
Active Markets
for Identical
Instruments

 

Significant
Other
Observable
Inputs

 

Significant
Unobservable
Inputs

 

 

 

2010

 

Level 1

 

Level 2

 

Level 3

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

Auction rate securities

 

35,177

 

 

 

35,177

 

Money market funds

 

23,179

 

23,179

 

 

 

Corporate bonds

 

19,633

 

19,633

 

 

 

U.S. government bonds

 

6,505

 

6,505

 

 

 

U.S. treasury bills

 

3,986

 

3,986

 

 

 

Put option

 

3,203

 

 

 

3,203

 

Time deposits

 

1,244

 

1,244

 

 

 

Foreign currency forward contract

 

451

 

 

451

 

 

Total assets

 

$

93,378

 

$

54,547

 

$

451

 

$

38,380

 

 

Assets measured at fair value on a recurring basis at December 31, 2009 are as follows (in thousands):

 

 

 

 

 

Fair Value Measurements at Reporting Data

 

 

 

December 31

 

Active Markets
for Identical
Instruments

 

Significant Other
Observable
Inputs

 

Significant
Unobservable
Inputs

 

 

 

2010

 

Level 1

 

Level 2

 

Level 3

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

Money market funds

 

$

54,884

 

$

54,884

 

$

 

$

 

Auction rate securities

 

40,626

 

 

 

40,626

 

Put option

 

2,933

 

 

 

2,933

 

Foreign currency forward contract

 

145

 

 

145

 

 

 

Total assets

 

$

98,588

 

$

54,884

 

$

145

 

$

43,559

 

 

The following table presents a reconciliation of all assets and liabilities measured at fair value on a recurring basis, excluding accrued interest components, using significant unobservable inputs (Level 3) for the three months ended March 31, 2010 (in thousands):

 

 

 

 

 

Auction Rate

 

 

 

 

 

Put Option

 

Securities

 

Total

 

Balance at December 31, 2009

 

$

2,933

 

$

40,626

 

$

43,559

 

Sales of auction rate securities

 

 

(5,175

)

(5,175

)

Loss on auction rate securities

 

 

(274

)

(274

)

Gain on put option

 

270

 

 

270

 

Balance at March 31, 2009

 

$

3,203

 

$

35,177

 

$

38,380

 

 

Fair value of Liabilities

 

The fair value of the Convertible Senior Notes (see Note 9 — Convertible Senior Notes) was estimated using quoted market prices. Accordingly, we have classified our convertible senior notes within Level 1 of the fair value hierarchy and have recorded the carrying value of the notes in long-term liabilities on our condensed consolidated balance sheet as of March 31, 2010.

 

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The following table summarizes the principal outstanding and estimated fair values of our debt (in thousands):

 

 

 

March 31, 2010

 

December 31, 2009

 

 

 

Carrying Value

 

Fair Value

 

Carrying Value

 

Fair Value

 

 

 

 

 

 

 

 

 

 

 

Convertible senior notes

 

$

77,615

 

$

84,189

 

$

76,531

 

$

81,075

 

 

5.            Goodwill and Intangible Assets

 

Goodwill is tested for impairment on an annual bases or more frequent upon the occurrence of circumstances that indicate that goodwill assets might be impaired.  We did not record any impairment of goodwill during the three months ended March 31, 2010.

 

The changes in carrying amount of goodwill for the three months ended March 31, 2010 is as follows (in thousands):

 

 

 

Three Months

 

 

 

Ended March 31,

 

 

 

2010

 

Goodwill, beginning of period

 

$

17,318

 

Effect of currency translation

 

(1,061

)

Goodwill, end of period

 

$

16,257

 

 

The following table provides additional information concerning intangible assets (in thousands):

 

Intangible assets are being amortized over straight-line periods ranging from 3 to 9 years.

 

 

 

 

 

March 31, 2010

 

December 31,
2009

 

 

 

Weighted
average
remaining life
(years)

 

Gross
carrying
amount

 

Accumulated
amortization

 

Cumulative
effect of
currency
translation

 

Net book
value

 

Net book value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Patent and Licenses

 

8.5

 

$

25,750

 

$

(2,578

)

$

 

$

23,172

 

$

23,854

 

Customer relationships

 

6.8

 

5,024

 

(1,208

)

(368

)

3,448

 

3,809

 

Covenant not to compete

 

0.8

 

71

 

(51

)

(3

)

17

 

24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total intangibles

 

 

 

$

30,845

 

$

(3,837

)

$

(371

)

$

26,637

 

$

27,687

 

 

6.     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 (in thousands):

 

 

 

March 31,

 

December 31,

 

 

 

2010

 

2009

 

Raw materials

 

$

20

 

$

92

 

Work-in-progress

 

1,164

 

1,577

 

Finished goods

 

3,939

 

3,239

 

Total

 

$

5,123

 

$

4,908

 

 

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7.     Warranty

 

We offer warranties on our product and record a liability for the estimated future costs associated with warranty claims, which is based upon our historical experience and our estimate of the level of future costs. Warranty costs are reflected in the statement of operations as a cost of goods sold.  A reconciliation of the changes in warranty liability for the three months ended March 31, 2010 and 2009 are as follows (in thousands):

 

 

 

Three months ended March 31,

 

 

 

2010

 

2009

 

Balance at the beginning of the period

 

$

277

 

$

272

 

Accruals for warranties issued during the period

 

160

 

59

 

Settlements made in kind during the period

 

(143

)

(99

)

Balance at the end of the period

 

$

294

 

$

232

 

 

8.     Stock-Based Compensation

 

Net loss for the first quarter of 2010 included stock-based compensation expense under ASC 718, Compensation — Stock Compensation (“ASC 718”), of approximately $1.7 million, which consisted of stock-based compensation expense of approximately $1.5 million related to employee stock options, employee stock purchase plan and stock appreciation rights and stock-based compensation expense of approximately $0.2 million related to employee restricted stock and restricted stock units.

 

Net loss for the first quarter of 2009 included stock-based compensation expense under ASC 718 of approximately $1.3 million, which consisted of stock-based compensation expense of approximately $1.1 million related to employee stock options, employee stock purchase plan and stock appreciation rights and stock-based compensation expense of approximately $0.2 million related to employee restricted stock and restricted stock units.

 

Stock-based compensation arrangements to non-employees are accounted for in accordance with ASC 505-50 Equity Based Payments to Non-Employees, which requires that these equity instruments are recorded at their fair value on the measurement date. The measurement of stock-based compensation is subject to adjustment as the underlying equity instruments vest. Stock-based compensation expense relating to non-employees was approximately $32,000 and $0 for the three months ended March 31, 2010 and 2009, respectively.

 

For the three months ended March 31, 2010 and 2009, we calculated the fair value of each stock option and stock appreciation right on the date of grant using the Black-Scholes model as prescribed by ASC 718.  The assumptions used were as follows:

 

 

 

Three Months Ended March 31,

 

 

 

2010

 

2009

 

Expected term (in years)

 

4.15

 

4.35

 

Average risk-free interest rate

 

1.97

%

1.61

%

Average volatility factor

 

51.4

%

52.6

%

Dividend yield

 

 

 

 

Stock Options and Stock Appreciation Rights: During the three months ended March 31, 2010, we granted stock appreciation rights for 457,500 shares of common stock, with an estimated total grant date fair value of approximately $3.8 million and a grant date weighted-average fair value of $8.31 per share.  During the three months ended March 31, 2009, we granted stock appreciation rights for 842,057 shares of common stock, with an estimated total grant date fair value of approximately $4.2 million and a grant date weighted-average fair value of $4.99 per share.

 

Restricted Stock Units: In connection with restricted stock units granted, we recorded stock compensation expense representing the fair market value of our common shares on the dates the awards were granted. Compensation expense is being recorded on a straight-line basis over the vesting periods of the underlying stock awards. During the three months ended March 31, 2010, we granted 58,437 restricted stock units, with a grant-date fair value of approximately $1.1 million and a grant-date weighted-average fair value of $19.52.  During the three months ended March 31, 2009, we granted 24,489 restricted stock units, with a grant-date fair value of approximately $0.3 million and a grant-date weighted-average fair value of $12.25.

 

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9.     Convertible Senior Notes

 

In February 2007, we issued an aggregate principal amount of $86.3 million of our 2.25% convertible senior notes due 2027. These notes bear a 2.25% interest per annum on the principal amount, payable semiannually in arrears on February 15 and August 15 of each year, beginning on August 15, 2007.

 

The notes will mature on February 15, 2027, unless earlier redeemed, repurchased or purchased by us or converted, and are convertible into cash and, if applicable, shares of our common stock based on an initial conversion rate, subject to adjustment, of 35.8616 shares per $1,000 principal amount of notes (which represents an initial conversion price of approximately $27.89 per share), in certain circumstances. Upon conversion, a holder would receive cash up to the principal amount of the note and our common stock in respect of such note’s conversion value in excess of such principal amount. The notes are convertible only in the following circumstances: (1) if the closing sale price of our common stock exceeds 120% of the conversion price during a period as defined in the indenture; (2) if the average trading price per $1,000 principal amount of the notes is less than or equal to 97% of the average conversion value of the notes during a period as defined in the indenture; (3) upon the occurrence of specified corporate transactions; (4) if we call the notes for redemption and (5) at any time on or after December 15, 2011 up to and including February 15, 2012 and anytime on or after February 15, 2025. Upon a change in control or termination of trading, holders of the notes may require us to repurchase all or a portion of their notes for cash at a repurchase price equal to 100% of the principal amount, plus any accrued and unpaid interest. We may not have sufficient funds to pay the interest, purchase price, repurchase price or principal return when conversion is triggered or a note becomes payable under the above terms.

 

We concluded that the embedded stock conversion option is not considered a derivative under ASC 815 Derivative and Hedging (“ASC 815”), because the embedded stock conversion option would be recorded in stockholders’ equity if it were a freestanding instrument.

 

In connection with the offering, we entered into convertible note hedge transactions with affiliates of the initial purchasers. These transactions are intended to reduce the potential dilution to our Company’s stockholders upon any future conversion of the notes. The call options, which cost an aggregate $19.4 million, were recorded as a reduction of additional paid-in capital. We also entered into warrant transactions concurrently with the offering, pursuant to which we sold warrants to purchase approximately 3.1 million shares of our common stock to the same counterparties that entered into the convertible note hedge transactions. The convertible note hedge and warrant transactions effectively increased the conversion price of the convertible notes to approximately $36.47 per share of our common stock. Proceeds received from the issuance of the warrants totaled approximately $10.7 million and were recorded as an addition to additional paid-in capital.

 

ASC 815 provides that contracts are initially classified as equity if (1) the contract requires physical settlement or net-share settlement, or (2) the contract gives the company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The settlement terms of our purchased call options and sold warrant contracts require net-share settlement. Based on the guidance in ASC 815, the purchased call option contracts were recorded as a reduction of equity and the warrants were recorded as an addition to equity as of the trade date. ASC 815 states that a reporting entity shall not consider contracts to be derivative instruments if the contract issued or held by the reporting entity is both indexed to its own stock and classified in stockholders’ equity in its statement of financial position. We concluded the purchased call option contracts and the warrant contracts should be accounted for in stockholders’ equity.

 

Adoption of ASC 470-20

 

ASC 470-20 Debt with Conversion and Other Options (“ASC 470-20”) clarifies the accounting for convertible debt instruments that may be settled in cash upon conversion, including partial cash settlement.  ASC 470-20 specifies that an issuer of such instruments should separately account for the liability and equity components of the instruments in a manner that reflect the issuer’s non-convertible debt borrowing rate which interest costs are recognized in subsequent periods.  ASC 470-20 is effective for fiscal years beginning after December 15, 2008, and retrospective application is required for all periods presented.  We adopted ASC 470-20 in the first quarter of fiscal 2009.

 

The effect of the adoption of ASC 470-20 was to bifurcate the debt and equity components of our convertible notes. The note payable principal balance at the date of issuance of $86.3 million in February 2007 was bifurcated into the debt component of $65.1 million and the equity component of $21.2 million.  The difference between the note payable principal balance of $86.3 million and the $65.1 million value of the debt component is being accreted to interest expense over a period of 5 years, which is the expected term of our notes payable.  We reclassified $0.8 million of debt issuance costs to additional paid in capital.  The debt component was recognized at the present value of its cash flows discounted using a 5.51% discount rate, our borrowing rate at the date of the issuance of the Debenture for a similar debt instrument without the conversion feature.

 

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Interest expense associated with the Convertible Senior Notes consisted of the following (in thousands):

 

 

 

Three months ended March 31,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

Contractual coupon rate of interest

 

$

478

 

$

478

 

Accretion of notes payable

 

1,084

 

1,025

 

Interest expense - convertible senior notes

 

$

1,562

 

$

1,503

 

 

The carrying amounts of the Convertible Senior Notes are as follows (in thousands):

 

 

 

March 31,

 

December 31,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

Beginning carrying amount

 

$

76,531

 

$

72,344

 

Accretion of note payable

 

1,084

 

4,187

 

Carrying amount

 

$

77,615

 

$

76,531

 

 

10.     Credit Line

 

In November 2008 we entered into a revolving credit line agreement with UBS, payable on demand, in an amount equal to 75% of the fair value of our ARS at a net no cost, meaning that the interest we pay on the credit line will not exceed the interest that we receive on the ARS that we have pledged as security for the credit line. Additionally, if UBS is able to sell our ARS at par value, proceeds would be utilized to first repay any outstanding balance under the revolving credit line. We are still able to sell the ARS, but in such a circumstance, if we sold the ARS at less than par, we would not be entitled to recover the par value support from UBS.  During the three months ended March 31, 2010 we borrowed an additional $1.8 million, and repaid $5.4 million under this line of credit, and our loan balance as of March 31, 2010 was $25.7 million.  Our loan balance as of December 31, 2009 was $29.2 million.  We intend to repay this line of credit in entirety when we exercise our Right to have UBS purchase the underlying ARS at full par value in June 2010.  Our line of credit is payable on demand and we classify as short term.  We believe the fair value equals the balance sheet value.  See Note 3 — Investments.

 

11.  Income Taxes

 

We adopted the provisions of ASC 740 Income Taxes or (“ASC 740”) on January 1, 2007.  The adoption of the provisions, did not have a material impact on our financial position and results of operations.   We have not been audited by the Internal Revenue Service or any state income or franchise tax agency.   As of March 31, 2010, our federal returns for the years ended 2006 through the current period and most state returns for the years ended 2005 through the current period are still open to examination.  In addition, all of the net operating losses and research and development credit carryforwards that may be used in future years are still subject to inquiry given that the statute of limitation for these items would be from the year of the utilization. The tax returns for Conceptus SAS for the years ended 2005 to 2007 were examined and closed by the French tax authorities in 2008.

 

For the three months ended March 31, 2010 and 2009, we recorded approximately $0.1 million of income tax expense.

 

The amount of unrecognized tax benefits at March 31, 2010 was approximately $2.4 million, of which, if ultimately recognized, approximately $0.7 million would decrease the effective tax rate in the period in which the benefit is recognized. The remaining amount would be offset by the reversal of related deferred tax assets on which a valuation allowance is placed.

 

We do not expect our unrecognized tax benefits to change significantly over the next 12 months.  In connection with the adoption of ASC 740 we recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.

 

In preparing our condensed consolidated financial statements we are required to estimate our income taxes in each of the jurisdictions in which we operate. This process involves estimating our actual current tax exposure together with assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included within our condensed consolidated balance sheet. We must then assess

 

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the likelihood that our deferred tax assets will be recovered from future taxable income and to the extent to which we believe that recovery is not likely, we must establish a valuation allowance. To the extent we establish a valuation allowance or increase this allowance in a period, we must include an expense within the tax provision in the statement of operations. Due to experiencing only a short history of fiscal profitability and a loss for the three months ended March 31, 2010, management believes that there is sufficient uncertainty regarding the realization of deferred tax assets and a full valuation allowance is appropriate. Management reviews its assumptions regarding the realization of deferred tax assets on an ongoing basis. Continued profitability and future changes in management’s assumptions may result in a partial or full release of the deferred tax valuation allowance. A release of the valuation allowance would have a favorable impact on the tax provision within the statement of operations.

 

12.  Computation of Net Loss Per Share

 

Basic net loss per share excludes any potential dilutive effects of options, unvested restricted shares and restricted stock units and common stock shares subject to repurchase.  Diluted net loss per share includes the impact of potentially dilutive securities.  In net loss periods presented, basic and diluted net loss per share are both computed using the weighted average number of common shares outstanding.

 

The following table provides a reconciliation of weighted-average number of common shares outstanding to the weighted-average number common shares outstanding used in computing basic and diluted net loss per common share (in thousands):

 

 

 

Three months ended

 

 

 

March 31,

 

 

 

2010

 

2009

 

Numerator:

 

 

 

 

 

Numerator for diluted earning per share - Loss available to common stockholders

 

$

(2,351

)

$

(4,335

)

 

 

 

 

 

 

Denominator:

 

 

 

 

 

Weighted-average number of common shares outstanding

 

30,930

 

30,442

 

Less: Weighted-average unvested and restricted common shares

 

 

(4

)

Weighted-average number common shares outstanding used in computing basic and diluted net loss per common share

 

30,930

 

30,438

 

 

The following outstanding options, potential employee stock purchase plan shares, warrants, stock appreciation rights, restricted stock units and shares were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive (in thousands):

 

 

 

At March 31,

 

 

 

2010

 

2009

 

Outstanding options and stock appreciation rights

 

5,209

 

4,826

 

Restricted stock awards

 

 

4

 

Restricted stock units

 

157

 

101

 

Employee stock purchase plan

 

22

 

19

 

Warrants issued in connection with our convertible notes

 

3,093

 

3,093

 

Total

 

8,481

 

8,043

 

 

In February 2007, we issued an aggregate principal amount of $86.3 million of our 2.25% convertible senior notes due 2027.  The notes are not included in the calculation of net loss per share because their effect is anti-dilutive. In addition, our senior convertible notes were excluded from the diluted net income per share calculation because the conversion price was greater than the average market price of our stock during the period.

 

13.  Comprehensive Loss

 

Comprehensive loss represents all changes in stockholders’ equity except those resulting from investments or

 

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contributions by stockholders. Our comprehensive loss consists of cumulative translation adjustments. A summary of the comprehensive loss for the periods indicated is as follows (in thousands):

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2010

 

2009

 

Net loss

 

$

(2,351

)

$

(4,335

)

Other comprehensive loss

 

 

 

 

 

Foreign currency translation adjustment, net of tax

 

(1,069

)

(1,483

)

Change to unrealized loss on available-for-sale securities

 

(44

)

 

Comprehensive loss

 

$

(3,464

)

$

(5,818

)

 

The balance of each component of accumulated other comprehensive loss, net of taxes, as of March 31, 2010 and December 31, 2009 consist of the following (in thousands):

 

 

 

Foreign Currency
Translation

 

Unrealized Gains
(Loss) on Available-
For-Sale Securities

 

Accumulated
Other
Comprehensive
Loss

 

Balance as of December 31, 2009

 

$

(993

)

$

 

$

(993

)

Net change during the three month period

 

(1,069

)

(44

)

(1,113

)

Balance as of March 31, 2010

 

$

(2,062

)

$

(44

)

$

(2,106

)

 

14.  Segment Information

 

We operate in one business segment, which encompasses all geographical regions. We use one measurement of profitability and do not segregate our business for internal reporting.

 

Net sales by geographic region, based on shipping location of our customer, are as follows (in thousands, except percentages):

 

 

 

Three Months Ended March 31,

 

 

 

2010

 

2009

 

Net sales (in thousands)

 

$

33,358

 

$

27,151

 

 

 

 

 

 

 

United States of America

 

76

%

78

%

France

 

21

%

15

%

Rest of Europe

 

1

%

6

%

Other

 

2

%

1

%

 

No customer accounted for more than 10% of total revenue for the three months ended March 31, 2010 and 2009.  One customer accounted for 11% of our total gross accounts receivable at March 31, 2010.

 

15.  Legal Proceedings

 

On May 22, 2009, we filed a lawsuit in the United States District Court, Northern District of California against Hologic, Inc., (“Hologic”) seeking declaratory judgment by the Court that Hologic’s planned importation, use, sale or offer to sell of its forthcoming Adiana Permanent Contraception system will infringe several U.S. patents owned by us including U.S. Patent Nos. 6,634,361, 6,709,667, 7,237,552, 7,428,904 and 7,506,650, and an injunction prohibiting Hologic from importing, using, selling or offering to sell its Adiana system in the United States.  Upon FDA approval of the Adiana Permanent Contraception system, we filed an Amended Complaint in July 2009 seeking a judgment that Hologic’s importation, use, sale and/or offer to sell the system infringes the same patents mentioned above and requested an injunction against such activity.  On August 13, 2009, the Company filed a motion for preliminary injunction, requesting the Court to enjoin the Adiana system in the United States pending final judgment in the action. On August 25, 2009, Hologic filed its answer and asserted

 

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counterclaims against the Company that it was violating the Lanham Act and the California Statutory Unfair Competition Law. On October 14, 2009, the Company answered with its own counterclaims asserting that Hologic was violating the Lanham Act and the California Statutory Unfair Competition Law through its selling practices. A hearing was held on that motion on November 4, 2009 and an order denying the motion was issued on November 6, 2009, upon stipulation of the parties, on January 19, 2010, all claims relating to three of the five asserted patents were dismissed with prejudice. A claim construction hearing was held on March 10, 2010. The Claim Construction Order was issued on March 24, 2010 with all but one of five terms favorably construed to the Company.  On April 21, 2010 the court issued an order denying the Company’s Motion to Compel and granted the Company’s Motion to Amend its Complaint to assert counterclaims against Defendant that the Defendant had engaged in unfair competition against the Company and had violated the Lanham Act.  A trial date on the patent claims and unfair competition claims is scheduled for February 28, 2011.

 

From time to time, we are involved in legal proceedings arising in the ordinary course of business.  We believe there is no litigation pending that could have, individually or in the aggregate, a material adverse effect on our financial position, result of operations or cash flows.

 

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

 

The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes thereto. This discussion contains forward-looking statements, including references to 2010 revenues and gross margins, increased product adoption, product improvements, expanded sales force and other forecasted items that involve risks and uncertainties such as our limited operating and sales history; the uncertainty of market acceptance of our product; dependence on obtaining and maintaining reimbursement; effectiveness and safety of our product over the long-term; our ability to obtain and maintain the necessary governmental clearances or approvals to market our product; our ability to develop and maintain proprietary aspects of our technology; our ability to manage our expansion; our limited history of manufacturing our product; our dependence on single source suppliers, third party manufacturers and co-marketers; intense competition in the medical device industry and in the contraception market; the inherent risk of exposure to product liability claims and product recalls and other factors referenced in this Form 10-Q. Our actual results could differ materially from those expressed or implied in these forward-looking statements as a result of various factors, including those discussed in our Annual Report on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission on March 13, 2010 and those included elsewhere in this Form 10-Q.

 

Overview

 

We develop, manufacture and market the Essure® permanent birth control system, an innovative and proprietary medical device for women.   The Essure system delivers a soft and flexible insert into a woman’s fallopian tubes, causing benign tissue in-growth which blocks the fallopian tubes. A successfully placed Essure micro-insert and the subsequent tissue growth prohibits the egg from traveling through the fallopian tubes, preventing conception. The effectiveness rate of the Essure procedure determined in our clinical study is 99.8% after four years of follow-up.  We obtained approval to market Essure in the European Union in February 2001 and obtained the U.S. Food and Drug Administration, or FDA, approval for Essure in November 2002.  Over 370,000 women worldwide have undergone the Essure procedure.

 

On January 7, 2008, we acquired all of the outstanding shares of Conceptus SAS, based in Versailles, France.  As a result of this transaction, Conceptus SAS became a wholly-owned subsidiary, and through it we sell Essure directly in France and through a network of distributors throughout the rest of Europe. This acquisition expanded our presence in international markets and has increased our revenues as we now recognize sales at end-user pricing.

 

On December 15, 2008, we incorporated Conceptus Medical Limited (“CML”) as a wholly owned subsidiary in the United Kingdom to serve as our direct sales office in the United Kingdom after terminating our distributor relationship with our previous distributor during the fourth quarter of 2008.  This incorporation further expanded our presence in international markets and has increased our revenues as we now recognize sales at end-user pricing in United Kingdom.

 

During 2009 we received a National Institute for Health and Clinical Excellence (“NICE”) positive recommendation in the United Kingdom and an approval for the Essure procedure from the Brazilian National Health Service.  During 2009, we sold the Essure system in twenty two countries.  For financial information about geographic areas and for segment information with respect to net sales, refer to the information set forth in Note 14 — Summary of Significant Accounting Policies in the Notes to Condensed Consolidated Financial Statements.

 

We were incorporated in the state of Delaware on September 18, 1992.  We maintain three websites located at www.conceptus.com, www.essuremd.com and www.essure.com. We make available free of charge on or through our www.conceptus.com website, our annual report on Form 10-K, our quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file or furnish such material to the Securities and Exchange Commission (SEC).

 

The Essure Procedure

 

The Essure micro-insert is designed to be placed into each fallopian tube during a single procedure using a hysteroscope, an instrument that allows visual examination of the cervix and uterine cavity, and our minimally invasive delivery system. The delivery system is a disposable plastic handle that is connected to our proprietary guidewire and catheter system. The micro-insert is constructed of a stainless steel inner coil, a dynamic outer coil made from a nickel titanium alloy, called Nitinol, and a layer of polyethylene terephthalate, or polyester fibers, wound between the inner coils. Using the hysteroscope for guidance, the delivery catheter is guided through the uterus and into the opening of the fallopian tube. Once the physician has properly positioned the delivery system in the fallopian tube, the physician releases the micro-insert. When released, the micro-insert automatically expands to the contours of the fallopian tube and anchors itself in place.  Over a three-month time

 

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frame, the polyester fibers within the micro-insert elicit a localized, benign tissue in-growth that occludes, or blocks, the fallopian tubes, thereby preventing conception.

 

Currently, local anesthesia is used as the predominate method of controlling discomfort during the Essure procedure General anesthesia is not typically used unless required by hospital protocol, if requested by the patient, or based on the experience and comfort level of the physician.   The Essure procedure can be performed in the comfort of a physician’s office in less than ten minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation.  A patient is typically discharged approximately 45 minutes after the Essure procedure. No overnight hospital stay is required. Furthermore, the Essure procedure is effective without drugs or hormones. There is a three-month waiting period after the Essure procedure is completed during which the patient must continue to use her current form of birth control or an alternative form while tissue in-growth occurs.  After three months, U.S. patients complete a confirmation test called a hysterosalpingogram, or HSG, which provides confirmation to both the doctor and the patient of the placement of the inserts and the occlusion of the fallopian tubes. Outside of the United States, the confirmation test is a standard flat plate pelvic X-ray conducted three months after completion of the procedure, with a subsequent HSG if device location on the initial radiographic image appears suspicious.

 

The Essure Procedure Benefits

 

With 99.8% effectiveness based on four years of follow up, the Essure procedure is the most effective form of permanent contraception on the market based on a comparison of four-year clinical trial data.  We developed the Essure procedure in response to the market need for a less invasive and more cost effective solution for women whose families are complete.  The Essure procedure is typically performed in an office setting without general anesthesia and women typically can return to their daily activities within one day.  Other permanent birth control procedures, such as tubal ligation or vasectomy, are done in a hospital setting, entail general anesthesia and require additional recovery time.

 

Benefits for the patients:

·                  Proven: four-year effectiveness rate of 99.8%;

·                  Performed in the comfort of the doctor’s office in less than 10 minutes;

·                  No risks associated with incisions, general anesthesia or RF energy (common in other permanent birth control procedures);

·                  No hormones;

·                  Short recovery time.  Most women are discharged within 45 minutes and they return to normal activities within 24 hours;

·                  Confirmation: A confirmation test provides women with certainty that they are protected against unplanned pregnancy;

·                  Convenience: No recurring management of contraception usage after the confirmation test, which is performed 90 days after the initial procedure.

 

Benefits to the physician and healthcare system:

·                  More cost effective and efficient solution: Due to savings related to cost and time such as:

·                  Elimination of overhead,

·                  Indirect and procedural costs related to anesthesia,

·                  Post-operative care and hospital stays associated with tubal ligations;

·                  Short procedure time and relative ease of performing the procedure;

·                  Ability to visually confirm proper placement of micro-insert during the procedure:

·                  No risks associated with: incisions, thermal injuries, bowel injuries or dilutional hyponatremia, glycine, or general anesthesia and;

·                  Less resource-intensive environment: While Essure procedures may be performed in various settings including the physician office, hospital operating room and an ambulatory surgery center, the majority of Essure procedures now take place in physicians’ offices.

 

Benefits to the payers:

·                  Lower cost procedure:  Due to reduced use of general or regional anesthesia and reduced number of post-operative hospital stays;

·                  Elimination of costs:  No operating room expenses because the procedure can be performed in the physician’s office; and

·                  Cost savings resulting from the potential reduction of unplanned pregnancies.

·                  Most effective form of permanent birth control based on 4 years of clinical studies.

 

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Physician Penetration

 

We require physicians to be preceptored for between 3 and 5 cases by a certified trainer before being able to perform the procedure independently. We continue to see an increase in the number of physicians becoming trained or who are in the process of training to perform the Essure procedure. The level of sales for the Essure system is highly dependent on the number of physicians trained to perform the procedure. However, we understand that a strong base of trained physicians does not necessarily correlate to an increase in revenue proportionately. Furthermore, there are no revenues associated with the training activities. We do not charge a fee for the activity and no commitment arises for the physician from the preceptorship.

 

Reimbursement of the Essure Procedure

 

Market acceptance of the Essure system depends in part upon the availability of reimbursement within prevailing healthcare payment systems. We believe that physician advocacy of our product will be required to continue to obtain reimbursement. As of March 31, 2010 we have received positive coverage decisions for the Essure procedure from most private insurers and from all of the 51 Medicaid programs and favorable office reimbursements in 26 states (defined as $1,800 or more) in the United States. We continue to receive positive responses relating to reimbursement, which we believe will help increase the adoption of the Essure device by doctors and patients. We intend to continue our effort to educate payers of the cost-effectiveness of our product and to establish further programs to help physicians to navigate reimbursement issues. As with all healthcare plans, coverage will vary and is dependent upon the individual’s specific benefit plan.

 

Effective January 1, 2010, the Centers for Medicare and Medicaid Service (“CMS”), the Medicare Physician Fee Schedule national average payment for hysteroscopic sterilization (“CPT code”) is $423.05 when performed in a hospital (facility) and $1,822.41 (non-facility) when performed in a physician’s office. In addition, in the CMS Final Rule for the 2010 Outpatient Prospective Payment System, or OPPS, which assigns hospital outpatient reimbursement amounts, CPT 58565 maps to APC 202 which is assigned a Medicare National Average of $3,032.56, which under Medicare includes the cost of the implant.  In 2010, the Medicare national average payment for hysteroscopic sterilization in the Ambulatory Surgery Center (“ASC”) is $1,671.96, which includes the cost of the implant. We believe these values are favorable for the Essure procedure and will help in establishing increased utilization of the device amongst doctors.

 

Reimbursement systems 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 healthcare systems that determine reimbursement for new devices and procedures. In most markets, there are private insurance systems as well as government-managed systems.

 

During the last several years, we received several positive responses from government and private agencies relating to reimbursement, which we believe will help us to speed up the acceptance of the Essure procedure by doctors and patients. In Europe, we are developing a strategic plan to obtain reimbursement in a number of European countries. In France, we have obtained official reimbursement with the Haute Autorité de Santé (“HAS”). The Essure procedure is covered in France for all age-appropriate women, regardless of their medical status.  The Economic Committee for Healthcare Devices in France ruled in November 2007 that the reimbursement for the Essure device will remain at the then current levels of 663 Euros, net of value added tax, for the next five years.

 

We have experienced significant cumulative operating losses since inception and, as of March 31, 2010, had an accumulated deficit of $236.7 million. Although we were profitable in 2009, we experienced a net loss in the first quarter of 2010 and there is a risk that we may not sustain profitability.   We will continue to expend substantial resources in the selling and marketing of the Essure system in the United States and abroad. We will be in a net loss position unless sufficient revenues can be generated to offset expenses.

 

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Results of Operations - Three Months Ended March 31, 2010 and 2009

(in thousands, except percentages)

 

 

 

Three Months Ended March 31,

 

 

 

2010

 

2009

 

2010-
2009
%

 

 

 

Amount

 

% (a)

 

Amount

 

% (a)

 

Change

 

Net sales

 

$

33,358

 

100

%

$

27,151

 

100

%

23

%

Gross profit

 

26,967

 

81

%

21,395

 

79

%

26

%

Research and development expenses

 

1,746

 

5

%

1,407

 

5

%

24

%

Selling, general and administrative expenses

 

25,979

 

78

%

22,570

 

83

%

15

%

Net loss

 

(2,351

)

-7

%

(4,335

)

-16

%

46

%

 


(a) Expressed as a percentage of total net sales.

 

Net Sales

 

Net sales were $33.4 million for the three months ended March 31, 2010 as compared to $27.2 million for the three months ended March 31, 2009, representing an increase of approximately $6.2 million or 23%.  The increase is the result of continued commercialization and marketing of the Essure system worldwide and reflects the increasing numbers of physicians entering and completing training in the use of the procedure.  The increase also reflects continuation of our programs aimed at raising consumer and physician awareness of the Essure procedure.

 

International sales comprised 24% of our total net sales in the three months ended March 31, 2010.  International sales increased 33% compared to the three months ended March 31, 2009.  The increase in international sales reflects our continued focus on growing our current markets such as France and the expansion into new markets.  The net sales increase also reflects a domestic revenue increase of 20% in the three months ended March 31, 2010 as compared to the similar period in 2009.

 

Net sales by geographic region, based on shipping location of our customer, are as follows (in thousands, except percentages):

 

 

 

Three Months Ended March 31,

 

 

 

2010

 

2009

 

Net sales (in thousands)

 

$

33,358

 

$

27,151

 

 

 

 

 

 

 

United States of America

 

76

%

78

%

France

 

21

%

15

%

Rest of Europe

 

1

%

6

%

Other

 

2

%

1

%

 

No customer accounted for more than 10% of total revenue for the three months ended March 31, 2010 and 2009.  One customer accounted for 11% of our total gross accounts receivable at March 31, 2010.

 

We expect our net sales for 2010 to be in the range of approximately $160.0 million to $165.0 million, which would represent 22% to 26% growth from net sales in 2009 as we continue to increase the number of physicians performing the Essure procedure. We will also continue our programs aimed at raising patient awareness of the Essure procedure, such as radio, print and television advertising. We believe our revenue growth in 2010 and beyond will be significantly influenced by how successful we are in achieving our patient awareness objectives and physicians entering and completing training. However, as we have noted elsewhere in this Form 10-Q and risk factors from our Form 10-K, our expected revenue growth involves many risk factors, some of which are not entirely within our control.

 

Gross Profit

 

Cost of goods sold for the three months ended March 31, 2010 was $6.4 million as compared to $5.8 million for the three months ended March 31, 2009, this represents an increase of $0.6 million, or 11%.  Gross margin for the three months ended March 31, 2010 was 81% as compared to 79% for the comparable period in 2009. The quarter-over-quarter increase in gross

 

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margin is related to lower manufacturing costs associated with higher unit volume and a domestic price increase implemented during the latter part of the first quarter of 2010.  Our gross profit margin will vary as our geographic mix changes. Increases in sales of our devices through distributors in international markets will tend to decrease our overall gross profit margin.

 

Research and Development Expenses

 

Research and development expenses, which include expenditures related to product development, clinical research and regulatory affairs, were $1.7 million and $1.4 million for the three months ended March 31, 2010 and 2009, respectively, which represents an increase of $0.3 million, or 24%. As a percentage of revenues, research and development expenses for the three months ended March 31, 2010 and 2009 represented 5%, respectively.  The primary reason for the increase is due to higher cost related to consulting expenses and payroll related expenses for the next generation of Essure device.

 

Research and development expenses reflect clinical expenditures and product development, which are substantially related to the ongoing development and associated regulatory approvals of our technology. Our goal is to continue our product enhancements over the coming years, which are intended to result in improved ease of use and clinical performance. We expect to identify and hire additional research and development personnel in the future to staff our planned research and development activities, and we expect that these costs will increase as we seek to maintain our leading position in the market for permanent female birth control.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative spending for the three months ended March 31, 2010 were $26.0 million as compared to $22.6 million for the three months ended March 31, 2009, which represents an increase of $3.4 million, or 15%.  As a percentage of revenues, selling, general and administrative expenses for the three months ended March 31, 2010 and 2009 represented 78% and 83%, respectively.

 

The increases were primarily the result of payroll and stock compensation expenses of approximately $1.3 million, primarily due to the expansion of the U.S. field sales force.  Legal fees increased by approximately $0.8 million due to the litigation associated with defense of our patents.  Advertising expenditures increased by approximately $0.4 million primarily for our consumer-awareness campaign.  The increase also reflects the following:  increased rent, insurance and business taxes of approximately $0.3 million; increased travel related expenses of approximately $0.2 million; increased market research related expenses of approximately $0.2 million; and increased bad debt and banking fees of approximately $0.2 million.  We expect selling, general and administrative expenses to increase in the second quarter of 2010 as we expect to hire additional sales professionals and to continue our consumer-awareness campaign in targeted markets.

 

Total interest income and expenses and other income and expenses, net

 

Total interest income and expenses and other income and expenses, net for the three months ended March 31, 2010 was a net expense of $1.5 million as compared to a net expense of $1.6 million for the three months ended March 31, 2009, which represents a decrease of $0.1 million or 9%.

 

Total interest income, including the net amortization and accretion of premiums and discounts, in the three months ended March 31, 2010 was lower by 23% compared with the three months ended March 31, 2009.  Interest income, without the net amortization and accretion of premiums and discounts of approximately $0.1 million, increased by 12% due to the interest earned in available-for-sale investments such as time deposits, U.S. treasury bills, U.S. Government bonds and corporate bonds purchased during the first quarter of 2010.

 

Other income and expense, net increased by $0.3 million for the three months ended March 31, 2010 as compared to the three months ended March 31, 2009 primarily due to the foreign exchange loss in 2009.

 

Provision for income taxes

 

In accordance with ASC 740 Income Taxes or (“ASC 740”), the provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities, and for operating losses and tax credit carryforwards.  Deferred tax assets and liabilities are measured using the currently enacted tax rates that apply to taxable income in effect for the years in which those tax assets are expected to be realized or settled.  We record a valuation allowance to reduce deferred tax assets to the amount that is believed more likely than not to be realized. We evaluate the need for a valuation allowance for our deferred tax assets. Due to our cumulative pre-tax U.S. losses and the current

 

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uncertainty of our ability to realize our U.S. deferred tax assets, a valuation allowance in an amount equal to our U.S. deferred tax assets has been recorded.

 

We adopted the provisions of ASC 740, on January 1, 2007.  The adoption of ASC 740 with respect to uncertain tax positions did not have a material impact on our financial position and results of operations.   We have not been audited by the Internal Revenue Service or any state income or franchise tax agency.   As of March 31, 2010, our federal returns for the years ended 2006 through the current period and most state returns for the years ended 2005 through the current period are still open to examination.  The tax returns of Conceptus SAS for the years end 2005 to 2007 were examined and closed by the French tax authorities in 2008.  In addition, all of the net operating losses and research and development credit carryforwards that may be used in future years are still subject to inquiry given that the statute of limitation for these items would be from the year of the utilization.

 

For the three months ended March 31, 2010 and 2009, we recorded approximately $0.1 million of income tax expense.

 

The amount of unrecognized tax benefits at March 31, 2010 was approximately $2.4 million, of which, if ultimately recognized, approximately $0.7 million would decrease the effective tax rate in the period in which the benefit is recognized. The remaining amount would be offset by the reversal of related deferred tax assets on which a valuation allowance is placed.

 

We do not expect our unrecognized tax benefits to change significantly over the next 12 months.  In connection with the adoption of ASC 740 we recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense.

 

In preparing our condensed consolidated financial statements we are required to estimate our income taxes in each of the jurisdictions in which we operate. This process involves estimating our actual current tax exposure together with assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included within our condensed consolidated balance sheet. We must then assess the likelihood that our deferred tax assets will be recovered from future taxable income and the extent we believe that recovery is not likely, we must establish a valuation allowance. To the extent we establish a valuation allowance or increase this allowance in a period, we must include an expense within the tax provision in the statement of operations. Due to experiencing only a short history of fiscal profitability and a loss for the three months ended March 31, 2010, management believes that there is sufficient uncertainty regarding the realization of deferred tax assets and a full valuation allowance is appropriate. Management reviews its assumptions regarding the realization of deferred tax assets on an ongoing basis. Continued profitability and future changes in management’s assumptions may result in a partial or full release of the deferred tax valuation allowance. A release of the valuation allowance would have a favorable impact on the tax provision within the statement of operations.

 

Liquidity and Capital Resources

 

We have experienced significant cumulative operating losses since inception and, as of March 31, 2010, had an accumulated deficit of $236.7 million. Although we were profitable in 2009, we experienced a net loss in the first quarter of 2010 and there is a risk that we may not sustain profitability.   We will continue to expend substantial resources in the selling and marketing of the Essure system worldwide.  We will remain in an accumulated deficit position unless sufficient revenues can be generated to offset expenses.

 

As of March 31, 2010, we also held $38.4 million (par value) in auction rate securities (“ARS”) backed by federal and state student loans which are variable rate debt instruments and bear interest rates that reset approximately every 20-30 days. The fair value of ARS as of March 31, 2010 is $35.2 million.  These ARS have a contractual maturity ranging from 2028 through 2047.  Our ARS are classified short-term debt instruments.  Prior to 2008, our ARS were highly liquid, using a Dutch auction process that resets the applicable interest rate at predetermined intervals, typically every 20-30 days, to provide liquidity at par.  We have experienced failed auction in 2009 on some of our ARS.   The failures of these auctions do not affect the value of the collateral underlying the ARS, and we continue to earn and receive interest on our ARS at a pre-determined formula with spreads tied to particular interest rate indexes.

 

In November 2008, we accepted an offer from UBS AG, providing us with the Rights to require UBS to purchase our ARS at par value, which is defined as the price equal to the liquidation preference of the ARS plus accrued but unpaid dividends or interest, at any time during the period of June 2010 through July 2012.  Conversely, UBS has the right, in its discretion, to purchase or sell our ARS at any time until July 2012, so long as we receive payment at par value upon any sale or disposition.  We expect to sell our ARS under the Rights at par value in June 2010.  However, if the Rights are not exercised before July 2012 they will expire and UBS will have no further rights or obligation to buy our ARS.  So long as we

 

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hold our ARS, they will continue to accrue interest as determined by the auction process or the terms of the ARS if the auction process fails.  We had settlements of our ARS in the three months ended March 31, 2010 of $5.2 million at full par value.  UBS’s obligations under the Rights are not secured by its assets and do not require UBS to obtain any financing to support its performance obligations under the Rights.  UBS has disclaimed any assurance that it will have sufficient financial resources to satisfy its obligations under the Rights.

 

During the three months ended March 31, 2010, we invested $31.5 million in time deposits, U.S. treasury bills, U.S. government bonds and corporate bonds.  We will sell certain or all investments as needed to meet the cash flow needs of our business.  Hence our investments in time deposits, U.S. treasury bills, U.S. government bonds and corporate bonds are classified as available-for-sale securities in accordance with ASC 320 Investments — Debt and Equity Securities.  Investments are classified as short-term or long-term based on the underlying investments maturity date.  As of March 31, 2010 we had $17.5 million classified as short-term investments and $13.9 million classified as long-term investments.  See Note 3 — Investments in the Notes to Condensed Consolidated Financial Statements.

 

The successful achievement of our business objectives may require additional financing and therefore, we 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 sales and marketing activities. Our future liquidity and capital requirements will depend upon many factors, including, among others:

 

· Resources devoted to establish sales, marketing and distribution capabilities;

 

· The liquidity of auction rate securities held in our investment portfolio;

 

· The rate of product adoption by doctors and patients;

 

· Our determination to acquire or invest in other products, technologies and businesses;

 

· The market price of our common stock as it affects the exercise of stock options and the conversion terms of our convertible debt; and

 

· The insurance payer community’s acceptance of and reimbursement for the Essure system.

 

As of March 31, 2010, we had cash and cash equivalents of $29.5 million, compared to $61.7 million at December 31, 2009. In addition we had short-term and long-term investments of $66.6 million as of March 31, 2010, compared to $40.6 million of short-term investments at December 31, 2009.  The decrease of $32.1 million of cash and cash equivalents is primarily due to cash used in investing activities to purchase investments.

 

We believe that our existing cash and cash equivalents will be sufficient to meet our cash requirements for at least the next twelve months.

 

Sources and Uses of Cash

 

Our cash flows for the three months ended March 31, 2010 and 2009 are summarized as follows:

 

 

 

Three months ended
March 31,

 

 

 

2010

 

2009

 

Net cash used in operating activities

 

$

(2,482

)

$

(705

)

Net cash used in investing activities

 

(27,757

)

(848

)

Net cash (used in) provided by financing activities

 

(1,727

)

1,195

 

Effect of exchange rate changes on cash and cash equivalents

 

(148

)

(121

)

Net decrease in cash and cash equivalents

 

$

(32,114

)

$

(479

)

 

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Operating Activities

 

Net cash used in operating activities was $2.5 million in the three months ended March 31, 2010, as compared to $0.7 million used in the three months ended March 31, 2009.  Net cash used in operating activities in the three months ended March 31, 2010 was primarily related to:

 

·                  net loss of $2.4 million;

·                  non-cash related items such as accretion of notes payable, stock based compensation, depreciation and amortization of fixed assets, debt issuance costs amortization and intangible amortization were $4.8 million.

 

Net cash used in the operating activities in the three months ended March 31, 2009 was primarily related to:

 

·                  net loss of $4.3 million; and

·                  non-cash related items such as accretion of notes payable, stock based compensation, depreciation and amortization of fixed assets, debt issuance costs amortization and intangible amortization were $3.7 million.

 

Investing Activities

 

Net cash used in investing activities for the three months ended March 31, 2010 was $27.8 million, primarily due to investments purchases of $31.5 million and capital expenditures primarily related to purchases of additional hysteroscopy equipment of $1.4 million.  These were offset by the settlements of our ARS for $5.2 million at full par value during the three months ended March 31, 2010.

 

Net cash used in investing activities for the three months ended March 31, 2009 was $0.8 million, due to capital expenditures primarily related to purchases of additional hysteroscopy equipment.

 

Financing Activities

 

Net cash used in financing activities in the three months ended March 31, 2010 was $1.7 million.  This was due to $3.7 million from the issuance of common stock from our stock programs and from proceeds from our UBS line of credit, offset by repayment of our UBS line of credit of $5.4 million.  See Note 10 — Credit Line in the Notes to Condensed Consolidated Financial Statements.

 

Net cash provided by financing activities in the three months ended March 31, 2009 was $1.2 million due primarily from the issuance of common stock from our stock option programs and proceeds from our revolving credit line agreement with UBS.

 

CRITICAL ACCOUNTING ESTIMATES AND POLICIES

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions in certain circumstances that affect amounts reported in the accompanying condensed consolidated financial statements and related footnotes. A description of our critical accounting estimates and policies is included in our Annual Report on Form 10-K for the year ended December 31, 2009. In preparing these financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements, giving due consideration to materiality. The primary estimates underlying our financial statements include reserves for obsolete and slow moving inventory, allowance for doubtful accounts receivable, product warranty, impairment for long-lived assets, income taxes, stock-based compensation and contingent liabilities. Other accounting policies are described in section “Critical Accounting Estimates and Policies” in our Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2009. Application of these policies involves the exercise of judgment and use of assumptions as to future uncertainties and, as a result, actual results could differ from these estimates.

 

Recent Accounting Pronouncements

 

In January 2010, the FASB issued updated guidance related to fair value measurements and disclosures, which requires a reporting entity to disclose separately the amounts of significant transfers in and out of Level 1and Level 2 fair value measurements and to describe the reasons for the transfers. In addition, in the reconciliation for fair value measurements using significant unobservable inputs, or Level 3, a reporting entity should disclose separately information about purchases, sales, issuances and settlements (that is, on a gross basis rather than one net number). The updated guidance also requires that and entity should provide fair value measurement disclosures for each class of assets and liabilities and disclosures about the

 

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valuation techniques and inputs used to measure fair value for both recurring and non-recurring fair value measurements for Level 2 and Level 3 fair value measurements. The updated guidance is effective for interim or annual financial reporting periods beginning after December 15, 2009, except for the disclosures about purchases, sales, issuances and settlements in the roll forward activity in Level 3 fair value measurements, which are effective for fiscal years beginning after December 15, 2010 and for interim periods within those fiscal years. We have adopted this guidance in the first quarter of 2010.  See Note 4 — Fair Value Measurement in the Notes to Condensed Consolidated Financial Statements.

 

In February 2010, the FASB issued amended guidance on subsequent events. Under this amended guidance, SEC filers are no longer required to disclose the date through which subsequent events have been evaluated in originally issued and revised financial statements. We adopted this guidance in the first quarter of fiscal 2010 and the adoption did not have a material impact on our financial condition, results of operations, or cash flows.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

The following discusses our exposure to market risk related to changes in interest rates and foreign currency exchange rates. These exposures may change over time as business practices evolve and could have a material adverse impact on our financial results.

 

Interest Rate Risk:  We have been exposed to interest rate risk through interest earned on holdings of available-for-sale and trading marketable securities. We have experienced failed auctions in 2010 and 2009 of most all of our ARS and there is no assurance that auctions on these ARS in our investment portfolio will succeed in the future. As a result, our ability to liquidate our investments in the near term may be limited, and our ability to fully recover the carrying value of our investments may be limited or non-existent. An auction failure means that the parties wishing to sell securities could not carry out the transaction. If the issuers of these securities are unable to successfully close future auctions or their credit ratings deteriorate, we may be required to record further impairment charges on these investments. It could take until the final maturity of the underlying notes (up to 38 years) to realize our investments’ recorded value. As of March 31, 2010 we held $38.4 million (par value) in ARS, $35.2 million of fair value which are variable rate debt instruments and bear interest rates that are due to reset approximately every 20-30 days. In September 2009 we re-classified the ARS from long-term investments to short-term investments because our intention is to sell our ARS under the Rights at par value at the inception of the Rights period in the third quarter of 2010.   Due in part to these factors, our future investment income may fall short of expectations due to changes in interest rates or we may suffer losses in principal if forced to sell securities that have declined in market value due to changes in interest rates. Interest rates that may affect these items in the future will depend on market conditions and may differ from the rates we have experienced in the past.

 

We maintain an investment portfolio of various holdings, types, and maturities. The values of our investments are subject to market price volatility. Our primary objective for holding investments is to achieve an appropriate investment return consistent with preserving principal and managing risk.  As of March 31, 2010 we had short and long-term available-for-sale investments of $31.4 million recorded at fair value.  At any time, a sharp rise in interest rates could have a material adverse impact on the fair value of our investment portfolio, specifically investments in corporate bonds and U.S. government bonds. We had no outstanding hedging instruments for our investments as of March 31, 2010.  We monitor our interest rate and credit risks, including our credit exposures to specific rating categories and to individual issuers. We monitor our investment portfolio to ensure it is compliant with our internal investments policy.  We believe the overall credit quality of our portfolio is strong.  There were no impairment charges on our investments for the three months ended March 31, 2010.  A hypothetical 100 based point change in interest rates will not have a material impact on the fair value of our available-for-sale investments.  See Note 3 — Investments in the Notes to Condensed Consolidated Financial Statements.

 

Foreign Currency Exchange Risk:    A portion of our net sales are denominated in the Euro and the British Pound.  To date the foreign currency exchange risk related to British Pounds has been minimal due to the size of Conceptus Medical Limited.

 

We are exposed to foreign exchange rate fluctuations as we translate the financial statements of our foreign subsidiaries into U.S. Dollars in consolidation. If there is a change in foreign currency exchange rates, the translation of the foreign subsidiaries’ financial statements into U.S. Dollars will lead to translation gains or losses which are recorded net as a component of accumulated other comprehensive loss. We seek to manage our foreign exchange risk through operational means, including managing same currency revenues in relation to same currency expenses, and same currency assets in relation to same currency liabilities.  Periodically, during 2010 we entered into forward contracts to buy U.S dollars at fixed intervals in the retail market in an over-the-counter environment.  As of March 31, 2010, we had foreign currency forward contracts to sell 5.2 million Euros in exchange for $7.4 million maturing in April 2010 through July 2010.  As of March 31, 2010 these forward contracts are recorded at their fair value of $0.5 million in other current assets on our condensed

 

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consolidated balance sheet.  We have outstanding short-term intercompany receivables of $7.4 million as of March 31, 2010.  We expect the changes in the fair value of the intercompany receivables to be materially offset by the changes in the fair value of the forward contracts.  A potential loss in fair value resulting from a hypothetical 10 percent strengthening in the value of the U.S. dollar/local currency exchange rate would be approximately $0.7 million.

 

The purpose of these forward contracts is to minimize the risk associated with foreign exchange rate fluctuations.  We have developed a foreign exchange policy to govern our forward contracts.  These foreign currency contracts do not qualify as cash flow hedges and all changes in fair value are reported in earnings as part of other income and expenses.  We have not entered into any other types of derivative financial instruments for trading or speculative purpose.  Our foreign currency forward contract valuation inputs are based on quoted prices and quoted pricing intervals from public data and do not involve management judgment.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures:

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for 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 in reaching a reasonable level of assurance, management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

As of March 31, 2010, the end of our most recent fiscal quarter, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control Over Financial Reporting:

 

There was no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

Inherent Limitations of Internal Controls

 

Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations.  Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.

 

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PART II.  OTHER INFORMATION

 

Item 1. Legal Proceedings

 

On May 22, 2009, we filed a lawsuit in the United States District Court, Northern District of California against Hologic, Inc., (“Hologic”) seeking declaratory judgment by the Court that Hologic’s planned importation, use, sale or offer to sell of its forthcoming Adiana Permanent Contraception system will infringe several U.S. patents owned by us including U.S. Patent Nos. 6,634,361, 6,709,667, 7,237,552, 7,428,904 and 7,506,650, and an injunction prohibiting Hologic from importing, using, selling or offering to sell its Adiana system in the United States.  Upon FDA approval of the Adiana Permanent Contraception system, we filed an Amended Complaint in July 2009 seeking a judgment that Hologic’s importation, use, sale and/or offer to sell the system infringes the same patents mentioned above and requested an injunction against such activity.  On August 13, 2009, the Company filed a motion for preliminary injunction, requesting the Court to enjoin the Adiana system in the United States pending final judgment in the action. On August 25, 2009, Hologic filed its answer and asserted counterclaims against the Company that it was violating the Lanham Act and the California Statutory Unfair Competition Law. On October 14, 2009, the Company answered with its own counterclaims asserting that Hologic was violating the Lanham Act and the California Statutory Unfair Competition Law through its selling practices. A hearing was held on that motion on November 4, 2009 and an order denying the motion was issued on November 6, 2009, upon stipulation of the parties, on January 19, 2010, all claims relating to three of the five asserted patents were dismissed with prejudice. A claim construction hearing was held on March 10, 2010. The Claim Construction Order was issued on March 24, 2010 with all but one of five terms favorably construed to the Company.  On April 21, 2010 the court issued an order denying the Company’s Motion to Compel and granted the Company’s Motion to Amend its Complaint to assert counterclaims against Defendant that the Defendant had engaged in unfair competition against the Company and had violated the Lanham Act.  A trial date on the patent claims and unfair competition claims is scheduled for February 28, 2011.

 

From time to time, we are involved in legal proceedings arising in the ordinary course of business.  We believe there is no litigation pending that could have, individually or in the aggregate, a material adverse effect on our financial position, result of operations or cash flows.

 

Item 1A. Risk Factors

 

The risk factors included in our Annual Report as of December 31, 2009 on Form 10-K filed with the Securities and Exchange Commission on March 31, 2010 should be considered while evaluating Conceptus and our business. In addition to those factors and to other information in this Form 10-Q, the following updates to the risk factors as of March 31, 2010 should be considered carefully while evaluating the Company and our business.

 

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

 

The medical device industry is highly competitive and is characterized by rapid and significant technological change.  To compete successfully, we will need to continue to demonstrate the advantages of our Essure products and technologies over well-established alternative procedures, products and technologies, and convince physicians and other healthcare decision makers of the advantages of our products and technology. As we market the Essure system, we expect to compete with:

 

·                  other methods of permanent contraception, in particular tubal ligation;

 

·                  other companies that have developed or may be developing permanent contraception devices that are similar to or otherwise compete with the Essure system;

 

·                  other methods of non-permanent contraception, including devices such as intrauterine devices, or IUDs, vaginal rings, condoms and prescription drugs such as the birth control pill, injectable and implantable contraceptives and patches; and

 

We compete against other surgical procedures for permanent birth control, mechanical devices and other contraceptive methods, including existing methods of reversible birth control for both women and men.

 

The Essure procedure faces direct competition from Adiana, a hysteroscopic sterilization method that is manufactured and sold by Hologic, Inc. in Europe and the United States. We believe the Essure procedure has significant advantages over its competitor such as its higher effectiveness rate, no risks from the use of RF energy and the fact that the micro-inserts are radio-opaque, which enables the physician to visually confirm that the micro-inserts have been properly placed in the fallopian tubes.

 

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Many of our competitors possess a larger women’s health focused sales force and have access to the greater resources required to develop and market a competitive product than we do. In addition, new competition and products may arise due to consolidation within the industry and other companies may develop products that could compete with the Essure system. Our competitive position also depends on:

 

·                  widespread awareness, acceptance and adoption of our Essure product;

 

·                  our ability to respond promptly to medical and technological changes through the development and commercialization of new products;

 

·                  availability of coverage and reimbursement from third-party payers, insurance companies and others for the Essure procedure;

 

·                  the manufacture and delivery of our products in sufficient volumes on time, and accurately predicting and controlling costs associated with manufacturing, installation, warranty and maintenance of the products;

 

·                  our ability to attract and retain qualified personnel;

 

·                  the extent of our patent protection or our ability to otherwise develop proprietary products and processes; and

 

·                  securing sufficient capital resources to expand our sales and marketing efforts.

 

These and other competitive factors may render the Essure system obsolete or noncompetitive or reduce demand for the Essure system.

 

Our liquidity could be adversely impacted by adverse conditions in the financial markets.

 

At March 31, 2010, we had cash and cash equivalents of $29.5 million (excluding our investments in auction rate securities discussed below).  This available cash and cash equivalents are held in accounts at financial institutions and consist of invested cash and cash in our operating accounts.  The invested cash is invested in interest bearing money market funds managed by third party financial institutions.  These funds invest in direct obligations of the government of the United States and traditional money market funds.  We can provide no assurances that access to our invested cash and cash equivalents will not be impacted by adverse conditions in the financial markets.

 

We maintain an investment portfolio of various holdings, types, and maturities. These securities are classified as available-for-sale.  As of March 31, 2010 we had short and long-term investments of $31.4 million recorded at fair value.  Our portfolio includes time deposits, U.S. treasury bills, U.S. government bonds and corporate bonds, the values of which are subject to market price volatility to the extent unhedged. If such investments suffer market significant price declines, we may recognize in earnings the decline in the fair value of our investments below their cost basis when the decline is judged to be other than temporary. For information regarding the sensitivity of and risks associated with the market value of portfolio investments and interest rates refer to the section titled “Quantitative and Qualitative Disclosures About Market Risk.”

 

All of our cash and cash equivalents in our operating accounts are with third party financial institutions.  These balances exceed the Federal Deposit Insurance Corporation insurance limits.  While we monitor the cash balances in our operating accounts and adjust the cash balances as appropriate, these cash balances could be impacted if the underlying financial institutions fail or are subject to other adverse conditions in the financial markets.  To date we have experienced no loss or lack of access to cash in our operating accounts.

 

A portion of our investment portfolio is in auction rate securities.

 

As of March 31, 2009, we held approximately $38.4 million (par value), with a fair value of $35.2 million of investments consisting entirely of auction rate securities backed by federal and state student loans securities.  These auction rate securities have contractual maturities ranging from 2028 through 2047.  These investments have characteristics similar to short-term investments, because at pre-determined intervals, generally ranging from 20 to 30 days, there is a new auction process at which the interest rates for these securities are reset to current interest rates. At the end of each such period, we historically have either chosen to roll-over these securities or redeem the securities for cash.

 

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During 2008 and 2009, we experienced failed auctions of our auction rate securities and there is no assurance that auctions on these securities in our investment portfolio will succeed in the future. In November 2008, we accepted an offer from UBS, the fund manager with whom we hold our auction rate securities, pursuant to which UBS issued to us Series C-2 Auction Rate Securities Rights, or Rights, which allow us to sell the auction rate securities to UBS at par value during the period beginning June 2010 and ending July 2012. In exchange, the Company released UBS from claims that it may have for damages related to the auction rate securities (other than consequential damages), and we granted UBS the right to sell or otherwise dispose of the auction rate securities on its behalf (so long as we are paid the par value of the auction rate securities upon any disposition). We intend to sell our ARS under the Rights at the inception of the Rights period in June 2010.

 

The Rights are subject to a number of risks. Given the substantial dislocation in the financial markets and among financial services companies, we cannot assure you that UBS will ultimately have the ability to repurchase our auction rate securities at par, or at any other price during the put period described above.  We will be required to periodically assess the economic ability of UBS to meet that obligation in assessing the fair value of the Rights. Moreover, if we choose to not exercise the Rights or if UBS is unable to honor the Rights, our ability to liquidate our investments in the near term may be limited, and our ability to fully recover the carrying value of our investments may be limited or non-existent. If issuers of these securities are unable to successfully close future auctions or their credit ratings deteriorate, we may in the future be required to record further impairment charges on these investments. It could take until the final maturity of the underlying notes (up to 38 years) to realize our investments’ recorded value. Based on our ability to access our cash and cash equivalents, expected operating cash flows, and our other sources of cash, we do not anticipate that the current lack of liquidity on these investments will affect our ability to continue to operate our business in the ordinary course. However, we can provide no assurance as to when these investments will again become liquid or as to whether we may ultimately have to recognize additional impairment charges in our results of operations with respect to these investments.

 

Our business, financial condition, results of operations and cash flows could be significantly and adversely affected if certain types of healthcare reform programs are adopted in our key markets and other administration and legislative proposals are enacted into law.

 

The Health Care Reform Legislation was signed into law March 30, 2010 and among other provisions enacts an excise tax on medical device manufacturers on sales beginning January 1, 2013. There are numerous other provisions in the legislation. As a result, our effective tax rate and results of operations would be adversely affected and our ability to innovate and conduct necessary research and development to remain competitive with large, global companies could be negatively impacted.  We cannot predict what other healthcare initiatives, if any, will be implemented at the federal or state level, or the effect any future legislation or regulation will have on us. However, an expansion in government’s role in the U.S. healthcare industry may lower reimbursements for our products, reduce medical procedure volumes and adversely affect our business and results of operations, possibly materially.

 

We have been, and may be in the future, 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.

 

An adverse determination in new litigation or interference proceedings to which 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 the Essure system.

 

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. We are not a party to this lawsuit. 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

 

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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.

 

On May 22, 2009, we filed a lawsuit in the United States District Court, Northern District of California against Hologic, Inc., (“Hologic”) seeking declaratory judgment by the Court that Hologic’s planned importation, use, sale or offer to sell of its forthcoming Adiana Permanent Contraception system will infringe several U.S. patents owned by us including U.S. Patent Nos. 6,634,361, 6,709,667, 7,237,552, 7,428,904 and 7,506,650, and an injunction prohibiting Hologic from importing, using, selling or offering to sell its Adiana system in the United States.  Upon FDA approval of the Adiana Permanent Contraception system, we filed an Amended Complaint in July 2009 seeking a judgment that Hologic’s importation, use, sale and/or offer to sell the system infringes the same patents mentioned above and requested an injunction against such activity.  On August 13, 2009, the Company filed a motion for preliminary injunction, requesting the Court to enjoin the Adiana system in the United States pending final judgment in the action. On August 25, 2009, Hologic filed its answer and asserted counterclaims against the Company that it was violating the Lanham Act and the California Statutory Unfair Competition Law. On October 14, 2009, the Company answered with its own counterclaims asserting that Hologic was violating the Lanham Act and the California Statutory Unfair Competition Law through its selling practices. A hearing was held on that motion on November 4, 2009 and an order denying the motion was issued on November 6, 2009, upon stipulation of the parties, on January 19, 2010, all claims relating to three of the five asserted patents were dismissed with prejudice. A claim construction hearing was held on March 10, 2010. The Claim Construction Order was issued on March 24, 2010 with all but one of five terms favorably construed to the Company.  On April 21, 2010 the court issued an order denying the Company’s Motion to Compel and granted the Company’s Motion to Amend its Complaint to assert counterclaims against Defendant that the Defendant had engaged in unfair competition against the Company and had violated the Lanham Act.  A trial date on the patent claims and unfair competition claims is scheduled for February 28, 2011.

 

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Item 6. Exhibits

 

Number

 

Description

10.3

 

Amended Exhibit E - Product Pricing to the Medical Production Manufacturing Agreement by and between Conceptus, Inc. and Avail Medical Products, Inc. dated April 19, 2010.

31.1

 

Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

 

Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1

 

Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2

 

Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

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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.

 

Date: May 07, 2010

 

Conceptus, Inc.

 

/s/ Gregory E. Lichtwardt

 

Gregory E. Lichtwardt

 

Executive Vice President, Treasurer

 

and Chief Financial Officer

 

 

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