**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549**

**FORM 10-Q**

(Mark One)

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

For the quarterly period ended September 30, 2004

or

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

For thetransition period from ____ to _____Commission File No. 0-7955**MENTOR CORPORATION**(Exact Name of Registrant as Specified in its Charter)
|   | Minnesota | 41-0950791  (State or other jurisdiction of
(IRS Employer Identification    No.)  incorporation or organization)  
 201 Mentor Drive, Santa Barbara, California 93111(Address of Principal Executive Offices) (Zip Code)Registrant's telephone number including area code:  805/879-6000

Indicate by check mark whether the Registrant (1)has filed all reports required to be filed by Section 13 or 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or such shorterperiod that the Registrant was required to file such reports), and (2) has beensubject to such filing requirements for the past 90 days.  Yes x    No o

Indicate by check mark whether the Registrant isan accelerated filer (as defined in Rule 12b-2 of the Exchange Act).  Yes x    No o

As of November 5, 2004there were approximately 42,796,358 Common Shares, par value $.10, outstanding.
 
**MENTOR CORPORATION**
INDEX
Part I. Financial  Information

Item 1.

Financial Statements   

Consolidated Balance  Sheets (unaudited) – September 30, 2004 and March 31, 2004    

Consolidated Statements of Income (unaudited) – Three Months  Ended September 30, 2004 and 2003 

Consolidated Statements of Income (unaudited) – Six Months Ended  September 30, 2004 and 2003  

Consolidated Statements of Cash Flows (unaudited) -  Six Months Ended September 30, 2004 and 2003  

Notes to Condensed Consolidated Financial Statements – September  30, 2004 

Item 2.

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

Item 3.

Quantitative and Qualitative Disclosures About Market Risk 

Item 4.

Controls and Procedures 

Part II. Other  Information

Item 1.

Legal Proceedings   

Item 2.

Unregistered Sales of  Equity Securities and Use of Proceeds   

Item 3.

Defaults upon Senior  Securities   

Item 4.

Submission of Matters to  a Vote of Security Holders   

Item 5.

Other Information   

Item 6.

Exhibits 

2
PART I - FINANCIAL INFORMATION**Item 1.  Consolidated Financial Statements**
Mentor CorporationConsolidated Balance Sheets(Unaudited)

(in thousands)

**September 30, 2004**

March 31,   2004

**Assets**

** **

** **

Current assets:

** **

** **

  Cash and cash  equivalents

**$        127,189**

$        118,225

  Marketable  securities

**458**

193

  Accounts  receivable, net 

**102,967**

106,016

  Inventories

**73,449**

67,912

  Deferred  income taxes

**23,838**

22,488

  Prepaid  expenses and other

**16,750**

13,205

Total current assets

**344,651**

328,039

 

** **

 

Property and equipment,  net

**74,641**

77,529

Intangible assets, net

**48,320**

51,014

Goodwill, net

**23,820**

23,711

Long-term marketable  securities and investments

**35,194**

8,326

Other assets

**10,169**

10,160

 

**$        536,795**

$        498,779

See notes to condensed  consolidated financial statements.

** **

 

 

3

Mentor Corporation  Consolidated Balance Sheets  (Unaudited)

(in thousands)

**September 30,   2004**

March 31,   2004

**Liabilities and  shareholders' equity**

** **

 

Current liabilities:

** **

 

  Accounts  payable

**$    32,429**

$    37,126

  Warranty and  related reserves

**24,572**

23,396

  Accrued  compensation

**19,547**

18,212

  Short-term  bank borrowings

**9,385**

10,012

  Sales returns

**11,536**

11,797

 Deferred revenue

**11,654**

6,915

  Income taxes  payable

**-  **

285

  Current  portion of purchase price related to acquired         technologies and acquisitions

** **

**1,775**

 

1,864

  Interest  payable

**1,021**

1,187

  Dividends  payable

**7,260**

6,309

  Accrued  royalties

**708**

567

  Other

**14,921**

12,260

Total current liabilities

**134,808**

129,930

** **

 

Deferred income taxes

**2,569**

2,549

Deferred  revenue

**1,977**

**-  **

Long-term  accrued liabilities

**18,178**

17,996

Convertible subordinated  notes 

**150,000**

150,000

 

** **

 

Shareholders' equity:

** **

 

  Common Stock,  $.10 par value:

** **

 

    Authorized  - 150,000,000 shares; Issued and outstanding

** **

 

    42,784,558  shares at September 30, 2004;

** **

 

    42,059,136  shares at March 31, 2004;

**4,278**

4,206

  Capital in excess  of par value

**12,780**

**-   **

 Accumulated other  comprehensive income

**20,649**

19,122

  Retained  earnings

**191,556**

174,976

 

**229,263**

198,304

 

**     $    536,795**

     $    498,779

See notes to condensed  consolidated financial statements.

** **

 

 

4

Mentor Corporation  Consolidated Statements of Income  Three Months Ended September 30, 2004 and 2003  (Unaudited)

 

Three Months Ended  September 30,

(in thousands, except per  share data)

**2004**

2003

** **

 

Net sales

**$       108,779 **

$       93,263 

Cost of  sales

**40,638 **

35,561 

Gross  profit

**68,141 **

57,702 

** **

 

Selling, general and  administrative expense

**40,568 **

33,899 

Research and development  expense

**8,553 **

7,711 

 

**49,121 **

41,610 

 

** **

 

Operating income

**19,020 **

16,092 

 Interest expense

**(1,228)**

(149)

 Interest income

**533 **

323 

 Other income, net

**5 **

249 

Income before income  taxes

**18,330 **

16,515 

Income taxes

**5,796 **

5,277 

Net income

**$       12,534 **

$       11,238 

** **

 

Basic earnings per share

**$          0.29 **

$          0.24 

Diluted earnings per  share

**$          0.28 **

$          0.23 

Dividends per share

**$          0.17 **

$          0.15 

** **

 

Weighted  average shares outstanding

** **

 

Basic

**42,548**

46,562

Diluted

**45,238**

48,610

 

 

See notes to condensed  consolidated financial statements.

 

 

 

5

Mentor Corporation  Consolidated Statements of Income  Six Months Ended September 30, 2004 and 2003  (Unaudited)

 

Six Months Ended  September 30,

(in thousands, except per  share data)

**2004**

2003

** **

 

Net sales

**$     231,211 **

$     198,369 

Cost of sales

**84,613 **

74,934 

Gross profit

**146,598 **

123,435 

** **

 

Selling, general and  administrative expense

**83,820 **

69,578 

Research and development  expense

**16,583 **

15,254 

 

**100,403 **

84,832 

 

** **

 

Operating income

**46,195 **

38,603 

 Interest expense

**(2,636)**

(310)

 Interest income

**948 **

719 

 Other income  (expense), net

**(183)**

925 

Income before income  taxes

**44,324 **

39,937 

Income taxes

**14,136 **

12,666 

Net income

**$        30,188 **

$        27,271 

** **

 

Basic earnings per share

**$           0.71 **

$           0.59 

Diluted earnings per  share

**$           0.67 **

$           0.56 

Dividends per share

**$           0.32 **

$           0.17 

** **

Weighted  average shares outstanding

** **

Basic

**42,356**

46,475

Diluted

**45,138**

48,479

 

See notes to condensed  consolidated financial statements.

 

 

6

Mentor Corporation  Consolidated Statements of Cash Flows  Six Months Ended September 30, 2004 and 2003  (Unaudited)

(in thousands)

**2004**

2003

**Operating  Activities:**

** **

 

Net income

**$    30,188 **

$    27,271 

Adjustments to derive cash  flows from operating activities:

** **

 

  Depreciation 

**7,289 **

6,453 

  Amortization

**2,368 **

1,658 

  Deferred  income taxes 

**(1,631)**

(2,131)

  Tax benefit  from exercise of stock options

**3,223 **

2,778 

  (Gain) loss  on sale of assets

**1,436 **

(302)

  Imputed  interest on long-term liabilities

**15 **

139 

  (Gain) loss  on long-term marketable securities

**- **

136 

Changes in operating  assets and liabilities:

** **

 

    Accounts  receivable

**3,918 **

3,164 

    Inventories

**(4,836)**

(3,754)

    Prepaid  income taxes and other current assets

**(3,533)**

(8,096)

    Accounts  payable and accrued liabilities

**7,364 **

(326)

    Income  taxes payable

**(267)**

(439)

Net cash provided by  operating activities

**45,534 **

26,551 

**Investing  Activities:**

** **

 

Purchases of property and  equipment

**(4,829)**

(9,089)

Purchases of intangibles

**(1,500)**

(4,673)

Purchases of marketable  securities

**(69,028)**

(28,244)

Sales of marketable  securities

**41,854 **

21,466 

Acquisitions, net of cash  acquired

**- **

(7,192)

Net cash used for  investing activities

**(33,503)**

(27,732)

**Financing  Activities:**

** **

 

Repurchase of common  stock

**- **

(8,601)

Proceeds from exercise of  stock options

**9,628 **

6,602 

Dividends paid

**(13,637)**

(1,858)

Borrowings (repayments)  under line of credit agreements, net

**632 **

(128)

Net cash used for financing  activities

**(3,377)**

(3,985)

Effect of currency  exchange rates on cash and cash     equivalents

**310 **

  370 

Increase (decrease) in  cash and cash equivalents

**8,964 **

(4,796)

Cash and cash equivalents  at beginning of year

**118,225 **

105,840 

Cash and cash equivalents  at end of period

**$    127,189 **

$     101,044 

7

**MENTORCORPORATIONNOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTSSeptember 30, 2004**

**Note A - BusinessActivity**

Mentor Corporation (the "Company") wasincorporated in April 1969.  Unless the context indicates otherwise, whenwe refer to "Mentor," "we," "us," "our," or the "Company" in this Form 10-Q, we are referringto Mentor Corporation and its subsidiaries on a consolidated basis.  Wedevelop, manufacture and market a broad range of products serving the medicalspecialties market.  Our products are utilized by three primary segments,aesthetic and general surgery (plastic and reconstructive surgery), surgicalurology, and clinical and consumer healthcare.  Aesthetic and generalsurgery products include surgically implantable prostheses for plastic andreconstructive surgery as well as capital equipment and consumables used forsoft tissue aspiration or body contouring (liposuction).  Surgical urologyproducts include surgically implantable prostheses for the treatment ofimpotence, surgically implantable incontinence products, urinary care productsand brachytherapy seeds for the treatment of prostate cancer.  Clinicaland consumer healthcare products include catheters and other products for themanagement of urinary incontinence and retention. 

**Note B - Summary ofSignificant Accounting Policies**

The consolidated financial statementsinclude the accounts of the Company and all of its subsidiaries in which acontrolling interest is maintained.  For those subsidiaries where theCompany owns less than 100%, the outside shareholders' interests are treated asminority interests.  All inter-company accounts and transactions have beeneliminated.  Certain prior year amounts in previously issued financialstatements have been reclassified to conform to the current yearpresentation.  
Basis of Presentation 
The financial information for the three and six months endedSeptember 30, 2004 and 2003 is unaudited but includes all adjustments (consistingonly of normally recurring accruals, unless otherwise indicated) that theCompany considers necessary for a fair presentation of the results ofoperations for these periods.  Interim results are not necessarilyindicative of results for the full fiscal year.

**Use of Estimates**

Financial statements prepared in accordance with accountingprinciples generally accepted in the United States require management to makeestimates and judgments that affect amounts and disclosures reported in thefinancial statements.  Actual results could differ from thoseestimates.   A discussion of the Company’s significantaccounting policies is described in the “Application of CriticalAccounting Policies” section of “Management’s Discussion andAnalysis of Financial Condition and Results of Operations.”

8

**Effects of RecentAccounting Pronouncements**

In July 2004, the Financial Accounting Standards Board(FASB) released draft abstract Emerging Issue Task Force (EITF) Issue No.04-8, "The Effect of Contingently Convertible Debt on Diluted Earnings perShare," for comment. The objective of this Issue is toprovide guidance for whether contingently convertible debt instruments shouldbe included in diluted earnings per share calculations. The draft abstractreflects the Task Force’s tentative conclusion that contingentlyconvertible debt should be included in diluted earnings per share calculationsregardless of whether or not the trigger price has been reached. In itsSeptember meeting, the Task Force confirmed the July conclusion, and theguidance becomes effective December 15, 2004.  The impact of the Issuewill be to change the diluted earnings per share calculation by increasing netincome used in the numerator by the after tax amount of interest expenserelated to the convertible notes (approximately $800,000 for the quarter), andincreasing weighted average shares outstanding used in the denominator by 5.1million shares; the number of shares to be issued upon full conversion of theconvertible notes.  The effect would decrease diluted earnings per shareby $.02 cents per share for the quarter ended September 30, 2004.  Weexpect to adopt the guidance in the quarter ended December 31, 2004. 

In March 2004, the Financial Accounting Standards Board(FASB) approved the consensus reached on the EITF Issue No. 03-1, “TheMeaning of Other-Than-Temporary Impairment and Its Application to CertainInvestments.” The objective of this Issue is to provide guidance foridentifying impaired investments. EITF 03-1 also provides new disclosurerequirements for investments that are deemed to be temporarily impaired. Theaccounting provisions of EITF 03-1 are effective for all reporting periodsbeginning after June 15, 2004, while the disclosure requirements are effectiveonly for annual periods ending after June 15, 2004. We have evaluated theimpact of the adoption of EITF 03-1 and do not believe it will be significantto our results of operations or financial position.

**Note C - InterimReporting**

The Company's three quarterly interim reporting periods areeach thirteen-week periods ending on the Friday nearest the end of the thirdcalendar month of each calendar quarter.  The fiscal year end remainsMarch 31st.  To facilitate ease of presentation, each interimperiod is shown as if it ended on the last day of the appropriate calendarmonth.  The actual dates for each of the three interim quarters-end areshown below:

Fiscal 2005

Fiscal 2004

First Quarter

July 2, 2004

June 27, 2003

Second Quarter

October 1, 2004

September 26, 2003

Third Quarter

December 31, 2004

January 2, 2004

The accompanying unaudited condensed consolidated financialstatements for the three month and six month periods ended September 30, 2004and 2003 have been prepared in accordance with accounting principles generallyaccepted in the United States for interim financial information and withinstructions to Form 10-Q and Article 10 of Regulation S-X.  Accordingly,they do not include all of the information and footnotes required by accountingprinciples generally accepted in the United States for complete financialstatements.  In the opinion of management, all adjustments (consistingonly of normally recurring accruals, unless otherwise indicated) considerednecessary for a fair presentation of the results of operations for theindicated periods have been included.  Certain amounts recorded inprevious periods have been reclassified to conform to the current periodpresentation.  Operating results for the three month and six month periodsended September 30, 2004 are not necessarily indicative of the results for thefull fiscal year. 

The balance sheet at March 31, 2004 has been derived fromthe audited financial statements as of that date, but does not include all of theinformation and footnotes required by accounting principles generally acceptedin the United States for complete financial statements.

The condensed consolidated financial statements should beread in conjunction with the Company's Annual Report on Form 10-K for the yearended March 31, 2004.** **

9

**Note D - Cash Equivalents, Marketable Securities, andLong-Term Marketable Securities and Investments**

All highly liquid investments with maturities of threemonths or less at the date of purchase are considered to be cash equivalents.

The Company considers its marketable securitiesavailable-for-sale as defined in Statement of Financial Accounting Standards(SFAS) No. 115, "Accounting for Certain Investments in Debt and EquitySecurities."  Realized gains and losses, and declines in valueconsidered to be other than temporary, are included in income.  The costof securities sold is based on the specific identification method.  Forshort-term marketable securities, there were no material realized or unrealizedgains or losses, nor were there any material differences between estimated fairvalues, based on quoted market prices, and the costs of securities in theinvestment portfolio as of September 30, 2004, and March 31, 2004. Short-term investments, except auction rate securities, mature between threemonths and one year from the purchase date.  The Company's short-termmarketable securities consist primarily of money market mutual funds, U.S.state and municipal government and government agency obligations, auction ratesecurities, and investment grade corporate obligations including commercialpaper.  Auction rate securities carry interest or dividend rates thatreset every 28 days but have contractual maturities of greater than one year.

The Company's long-term marketable securities andinvestments include investments in Federal Home Loan Bank and MortgageAssociation bonds (FHLA bonds) with maturities of two to four years. 

10

**Available-for-sale investments at September 30, 2004 were asfollows**:

** **

** **

** **

**Gross**

**Gross**

**Estimated**

** **

** **

**Adjusted**

**Unrealized**

**Unrealized**

**Fair**

**(in thousands)**

**Cost**

**Gains**

**Losses**

**Value**

**Cash balances**

**$   38,333**

**$        -**

**$        - **

**$   38,333**

**Money market mutual  funds**

**88,856**

**-**

**- **

**88,856**

**Marketable equity  securities**

**144**

**-**

**(8)**

**136**

**U.S., state and municipal  agency      obligations**

**35,305**

** **

** (67)**

** 35,238**

**Corporate debt  securities**

**278**

**-**

**- **

**278**

**   Total  available-for-sale investments**

**$  162,916**

**-**

**$        (75)**

**$   162,841**

** **

** **

** **

** **

** **

**Included in cash and  cash equivalents**

**127,189**

**-**

**-**

**127,189**

**Included in current  marketable securities**

**458**

**-**

**- **

**458**

**Included in long-term  marketable      securities and investments**

**35,269**

**-**

**(75)**

**35,194**

**   Total  available-for-sale investments**

**$  162,916**

**$        -**

**$        (75) **

**$   162,841**

Available-for-saleinvestments at March 31, 2004 were as follows:

 

 

 

Gross

Gross

Estimated

 

 

Adjusted

Unrealized

Unrealized

Fair

(in thousands)

Cost

Gains

Losses

Value

Cash balances

$   19,139

$        -

$        - 

$   19,139

Bank time deposits

-

-

- 

-

Money market mutual funds

99,086

-

- 

99,086

Marketable equity securities

56

-

(8)

48

U.S., State and Municipal agency      obligations

  8,193

  -

  - 

  8,193

Corporate debt securities

278

-

- 

278

   Total available-for-sale  investments

$  126,752

-

(8)

$   126,744

 

 

 

 

Included in cash and cash equivalents

118,225

-

- 

118,225

Included in current marketable securities

193

-

- 

193

Included in long-term marketable      securities and investments

  8,334

  -

  (8)

  8,326

   Total available-for-sale  investments

$  126,752

$        -

$       (8)

$  126,744

**Note E -Inventories**

Inventories are stated at the lower of cost or market, costdetermined by the first-in, first-out (FIFO) method.  The Company writesdown its inventory for estimated obsolescence or unmarketable inventory equalto the difference between the cost of inventory and the estimated market valuebased upon assumptions about future demand and market conditions.

Inventories at September 30, 2004 and March 31, 2004consisted of:

(in thousands)

**September 30,**

March 31

Raw materials

**$      14,209**

$      13,050

Work in process

**       12,587**

       11,572

Finished goods

**      46,653**

      43,290

 

**$      73,449**

$      67,912

11

**Note F - Property andEquipment**

Property and equipment is stated at cost.  Depreciationis based on the useful lives of the properties and computed using thestraight-line method.  Buildings are depreciated over 30 years, furnitureand equipment over 3 to 10 years and leasehold improvements over the shorter oftheir estimated remaining lives or lease terms.  Significant improvementsand betterments are capitalized while maintenance and repairs are charged tooperations as incurred.

Property and equipment at September 30, 2004 and March 31,2004 consisted of:

(in thousands)

**September 30,**

March 31, 

Land

**$         566 **

$         561 

Buildings

**       24,883 **

       24,534 

Leasehold improvements

**     24,849 **

     23,776 

Furniture, fixtures and  equipment

**    106,196 **

    103,242 

Construction in progress

**       3,662 **

       3,811 

**    160,156 **

    155,924 

Less accumulated  depreciation

**     (85,515)**

     (78,395)

 

**$   74,641 **

$   77,529 

** Note G -Warranties**

The Companyprovides an accrual for the estimated cost of product warranties and productliability claims at the time revenue is recognized.  Such accruals arebased on estimates, which are based on relevant factors such as historicalexperience, the warranty period, estimated costs, levels of insurance andinsurance retentions, identified product quality issues, if any, and to alimited extent, information developed by the insurance company using actuarialtechniques.  The Company assesses the adequacy of these accrualsperiodically and adjusts the amounts as necessary based on actual experienceand changes in future expectations.

Informationon changes in the Company’s accrued warranties and related reserves areas follows:

Six Months Ended

September 30,

(in  thousands)

**2004**

2003

Beginning  warranty and related reserve

**$  23,396**

$  19,989

Costs of  warranty claims

**(2,122)**

(1,930)

Accruals  for product warranties

**3,298**

4,063

Ending  warranty and related reserves

**$  24,572**

$  22,122

**Note H - Other Comprehensive Income**

The components of comprehensive income are listed below:

 

Three Months Ended  September 30,

Six Months Ended   September 30,

(in thousands)

**2004**

2003

**2004**

2003

Net income

**$  12,534**

$  11,238

**$  30,188**

$  27,271

Foreign currency  translation adjustment

**1,613**

826

**1,571**

5,858

Unrealized (losses) on  marketable securities    and investment activities, net

**117**

  25

**(44)**

  146

Comprehensive income

**$  14,264**

$  12,089

**$  31,715**

$  33,275

12
Note I - Stock Options
The Company has granted options to key employees andnon-employee directors under its Amended 2000 Long-Term Incentive Plan (2000Plan) and 1991 Plan.  Options granted under both plans are exercisable infour equal annual installments beginning one year from the date of grant, andexpire ten years from the date of grant.  Options are granted at the fairmarket value as of the date of grant.  Options to purchase 732,750 sharesof common stock at $32.23 per share were granted during the quarter ended June30, 2004.  Options to purchase 47,500 shares of common stock at $34.58 pershare were granted during the quarter ended September 30, 2004.  

Stock option exercise prices are set at the fair marketvalue of the Company's common stock on the date of grant and the related numberof shares granted is fixed at that point in time.  Therefore, under theprinciples of Accounting Principles Board (APB) Opinion 25, the Company doesnot recognize compensation expense associated with the grant of stockoptions.  SFAS 123 "Accounting for Stock-Based Compensation",requires the use of an option valuation model to provide supplementalinformation regarding options granted after fiscal 1995.  Pro formainformation regarding net income and earnings per share shown below weredetermined as if the Company had accounted for its employee stock options underthe fair value method of that statement.  The estimated fair value of theoptions is amortized ratably over the options' vesting period.  As requiredby SFAS No. 148, "Accounting for Stock-Based Compensation - Transition andDisclosure - an amendment of FASB Statement No. 123", the following tableshows the estimated effect on net income and earnings per share if the Companyhad applied the fair value recognition provision of SFAS 123 to stock-basedemployee compensation.  The Company's pro forma information is as follows:

Three Months Ended  September 30,

Six Months Ended   September 30,

(in thousands except per  share data)

**2004**

2003

**2004**

2003

Net income: as  reported (1) 

**$  12,534**

$  11,238

**$  30,188**

$  27,271

Deduct: compensation  expense fair value method

**(1,787)**

(1,899)

**(3,555)**

(3,319)

Net income:  pro  forma

**$  10,747**

$   9,339 

**$  26,633**

$ 23,952 

** **

 

** **

 

Basic earnings per  share:  as reported

** $        .29**

    $       .24 

**$       .71**

$      .59 

Basic earnings per  share:  pro forma 

**$        .25**

$        .20 

**$       .63**

$      .51 

** **

 

** **

 

Diluted earnings per  share:  as reported

**$        .28**

$       .23 

**$       .67**

$      .56 

Diluted earnings per  share:  pro forma

**$        .24**

$       .20 

**$       .59**

$      .50 

(1) Net income as reported includes no compensation  expense associated with stock grants.

** **

 

** **

 

**Note J - Income Taxes**

The effective rate of corporate income taxes was 31.9% and31.7% for the six-month periods ended September 30, 2004 and 2003,respectively.   

13

**Note K - Earnings per Share**

Basic earnings per share is computed by dividing net incomeavailable to common shareholders by the weighted average number of shares ofthe Company’s common shares outstanding during the period. Dilutedearnings per share is calculated in the same manner as basic earnings per shareexcept that the number of shares outstanding is increased by potentiallydilutive common shares outstanding during the period.  Potentiallydilutive common shares consist of shares issuable under the terms of employeestock options, warrants, and the 23⁄4% convertible subordinatednotes.  A reconciliation of weighted average shares outstanding, used tocalculate basic earnings per share, to weighted average shares outstandingassuming dilution, used to calculate diluted earnings per share, follows:

Three Months Ended  September 30,

Six Months Ended   September 30,

(in thousands)

**2004**

2003

**2004**

2003

Weighted average outstanding shares:   basic
**42,548**46,562**42,356**46,475Shares issuable through exercise of stock options**2,690**2,048**2,782**2,004Weighted average outstanding shares:  diluted**45,238**48,610**45,138**48,479
Shares issuable through stock options are determined usingthe treasury stock method.  Certain potential shares issuable under theterms of employee stock options were excluded from the computation of dilutedearnings per share since their exercise prices were greater than the market pricesof the common shares during or at the end of the period, and accordingly, theireffect would have been anti-dilutive.  Shares potentially issuable uponthe conversion of the 23⁄4% convertible subordinated notes were excludedas the market prices of the common shares did not reach the specific levels forthe specified times required in order for the notes to allow conversion duringthe period.  Additionally, during the quarter ended September 30, 2004,the price of the Company’s stock did not exceed the specific strikeprices of the convertible bond hedge or the warrants for the specified timerequired that the Company entered into to reduce the potential dilution fromany conversion of the notes.  Both the bond hedge and the warrantstransaction may be settled at the Company’s option, either in cash orshares, and expire on January 1, 2009.  

**Note L - Share Repurchase Program**

The Company has a stock repurchase program, primarily tooffset the dilutive effect of our employee stock option program, to provideliquidity to the market and to reduce the overall number of sharesoutstanding.  All shares repurchased under the program are retired and areno longer deemed to be outstanding.  In May 1999, the Board of Directorsauthorized the repurchase of 9.2 million shares of our stock.  Each yearshares have been repurchased including 1.4 million shares for $22.3 million and1.5 million shares for $18.7 million in the years ended March 31, 2003 and2002, respectively.  At March 31, 2003, 1.8 million shares were remainingunder this authorization.  On July 31, 2003 the Board of Directorsincreased the authorized number of shares to be repurchased from 1.8 million to4 million shares.  On December 5, 2003, the Board of Directors increasedthe authorized number of shares to be repurchased by 5 million shares from 2.5million to 7.5 million shares.  During fiscal 2004, 5.4 million shareswere repurchased for $135.8 million and 3.6 million shares remained authorizedfor repurchase as of March 31, 2004 and September 30, 2004.  The timing ofrepurchases is subject to market conditions, cash availability, and blackoutperiods during which the Company is restricted fromrepurchasing shares.  There is no guarantee that shares authorizedfor repurchase by the Board will ultimately be repurchased. There were no sharerepurchases during the three-month and six-month periods ending September 30,2004.

14

**Note M - Acquisitions**

**SouthBay Medical LLC**

On January19, 2001, the Company purchased the assets of South Bay Medical LLC (SouthBay), a company focused on the development of a new computer-based workstationand automated cartridge-based needle loading system for use in brachytherapyprocedures.  The acquisition was accounted for as a purchase with theresults of operations included in the Company's financial statements from thedate of acquisition.  The Company paid $2 million in cash and issuedrestricted common stock valued at $4 million on the date of purchase. Additional purchase price payments will be made to South Bay over the nextseveral years as workstation sales are made.  The net present value ofthese amounts is recorded at September 30, 2004, in current accrued liabilities($775,000) and in long-term accrued liabilities ($10,550,000) as the Companybelieves it is probable these payments will be paid.  

**Prosurg,Inc.**

In December2001, the Company entered into several agreements with Prosurg, Inc., toacquire certain patent rights and obtain a source of supply of a bio-absorbableco-polymer for $2 million in cash and up to an additional $2 million upon theachievement of certain milestones.  The purchase price was allocated tointangible assets and the net present value of these amounts is recorded atSeptember 30, 2004, in accrued liabilities ($1,000,000) and in long-term accruedliabilities ($1,000,000) as the Company believes it is probable these paymentswill be paid.

**A-LifeLtd.**

On August 25, 2003, the Company completed the acquisition ofA-Life Ltd, which has developed a hyaluronic acid based dermal filler product,from Vitrolife, AB.  The acquisition was valued at $7.5 million; netof cash acquired, and was paid from existing cash balances.  The purchaseprice was allocated to the tangible and intangible net assets acquired on thebasis of their respective fair values on the acquisition date.  Thepurchase price was preliminarily allocated to accounts receivable of $36,000,other assets of $349,000, production equipment of $393,000 and intangibleassets of $6,821,000, net of accrued liabilities of $123,000. 

**Note N - Goodwill & Intangible Assets**

In 2001,the FASB issued SFAS No. 142, "Goodwill and Other IntangibleAssets".  SFAS No. 142 was effective for the Company as of April 1,2002.  SFAS No. 142 specifies the financial accounting and reporting foracquired goodwill and other intangible assets.  Goodwill and intangibleassets that have indefinite useful lives are no longer to be amortized, butrather are to be tested for impairment annually or more frequently ifimpairment indicators arise.  None of the Company's intangible assets havean indefinite life.  Intangible assets with finite lives continue to beamortized over their useful lives ranging from 3-20 years on a straight linebasis.  Goodwill and intangible assets have been recorded at either incurred orallocated cost.  Allocated costs were based on respective fair values atthe date of acquisition.  

Upon theadoption of SFAS No. 142, the Company reassessed the remaining amortizationperiods of intangible assets acquired on or before June 30, 2001, and assignedall goodwill to reporting units for impairment testing.  The impairmenttests involve the use of both estimates of fair value for the Company'sreporting units as well as discounted cash flow assumptions.  Impairmenttests were performed at adoption and in the fourth quarter of fiscal years 2004and 2003 and no impairment was noted as a result of these analyses. 

As ofSeptember 30, 2004 and March 31, 2004, accumulated amortization of intangibleassets was $16.6 million and $14.2 million respectively.

15

**Note O - Long-term Debt**

On December 22, 2003, the Company completed an offering of$150 million of convertible subordinated notes due January 1, 2024 pursuant toRule 144A under the Securities Act of 1933.  The notes bear interest at23⁄4% per annum and are convertible into shares of the Company's commonstock at a conversion price of $29.27 per share and are subordinated to allexisting and future senior debt. 

Holders of the notesmay convert their notes only if any of the following conditions is satisfied:
- during any fiscal quarter prior to January 1,     2019, if the closing price of the Company's common stock for at least 20     trading days in the 30 consecutive trading day period ending on the first     trading day of such fiscal quarter is more than 120% of the conversion     price per share of the Company's common stock on such trading day; 
- any     business day on or after January 1, 2019, if the closing price of the     Company's common stock on the immediately preceding trading day is more     than 120% of the conversion price per share of the Company's common stock     on such trading day; 
- during     the five business day period after any five consecutive trading day period     if the average of the trading prices of the notes for such five     consecutive trading day period is less than 98% of the average of the     conversion values of the notes during such period, subject to certain     limitations; 
- if the Company calls the notes for redemption; or 
- if the Company makes certain significant distributions     to holders of its common stock or the Company enters into specified     corporate transactions.

At an initial conversion price of $29.289, each $1,000principle amount of notes will be convertible into 34.1425 shares of commonstock.  As a result of the Company’s recent dividend increase the conversionprice has been adjusted to $29.27, and each $1,000 principle amount will beconvertible into 34.1632 shares of common stock.

Concurrent with the issuance of the convertible subordinatednotes, the Company entered into a convertible note hedge and a warrantstransaction with respect to its common stock, the exposure for which is held byCredit Suisse First Boston LLC.  Both the note hedge and the warrantstransaction may be settled at the Company's option either in cash or shares andexpire January 1, 2009.  The convertible note hedge and warrantstransactions combined are intended to reduce the potential dilution fromconversion of the notes by effectively increasing the conversion price pershare to $39.43.  The cost of the note hedge and  the proceeds ofwarrants sale have been included in stockholder's equity in accordance with theguidance in Emerging Issues Task Force No. 00-19, "Accounting forDerivative Financial Instruments Indexed to and Potentially Settled in aCompany's own Stock."  Any proceeds received or payments made upontermination of these instruments will be recorded in stockholders equity. 

16

**Note P - Business Segment Information**

The Company's operationsare principally managed and reported on a product basis.  There are threereportable segments:  aesthetic and general surgery, surgical urology, andclinical and consumer healthcare.  The accounting policies of thereportable segments are the same as those described in the summary ofsignificant accounting policies except that certain expenses such as interestand certain corporate expenses are not allocated to the segments.

The aesthetic and generalsurgery products segment consists primarily of breast implants, tissueexpanders and the Company's body contouring (liposuction) equipment anddisposables.  The surgical urology segment includes penile implants,surgical incontinence products, and brachytherapy seeds for the treatment ofprostate cancer.  The clinical and consumer healthcare segment includescatheters and other disposable products for the management of urinaryincontinence and retention.

Selected financial information for the Company's reportablesegments for the three-month and six-month periods ended September 30, 2004 and2003, and as of September 30, 2004 and March 31, 2004 is as follows:

 

17

Three  Months Ended   September 30,

Six  Months Ended  September 30,

 
(in thousands)

**2004**

2003

**2004**

2003

 
**Net sales**

** **

 

** **

 

 
Aesthetic and General Surgery

**$      54,322**

$      47,199  

**$     119,866**

$     102,702

 
Surgical Urology

**30,374**

23,903

**62,286**

51,992

 
Clinical and Consumer Healthcare 

**24,083**

22,161

**49,059**

43,675

 
  Total consolidated revenues

**$      108,779**

$      93,263

**$    231,211**

$    198,369

 
 

** **

 

 

 

 
Three  Months Ended   September 30,

Six  Months Ended  September 30,

 
(in thousands)

**2004**

2003

**2004**

2003

 
**Operating profit**

** **

 

 

 

 
Aesthetic and General Surgery

**$      18,390**

$      15,987 

**$      43,936**

$      35,777

 
Surgical Urology

**1,168**

(748)

**3,446**

788

 
Clinical and Consumer Healthcare

**2,645**

3,111 

**5,658**

6,433

 
  Total reportable segments

**$      22,203**

$      18,350 

**$       53,040**

$       42,998

 
 

 

 

 

 

 
Three  Months Ended   September 30,

Six  Months Ended  September 30,

 
(in thousands)

**2004**

2003

**2004**

2003

 
**Operating income**

** **

 

 

 

 
Reportable segments

**$     22,203 **

$     18,350   

**$     53,040 **

$     42,998   

 
Corporate operating expenses

**(3,183)**

(2,258)

**(6,845)**

(4,395)

 
Interest expense

**(1,228)**

(149)

**(2,636)**

(310)

 
Interest income

**533 **

323 

**948 **

719 

 
Other income

**5 **

249  

**(183) **

925 

 
Income before income taxes

**$     18,330 **

$     16,515 

**$      44,324 **

$      39,937 

 
 

 

 

 

 

 
 

As  of

 

 

  (in thousands)

**September  30, 2004**

March  31,  2004

 
**Identifiable assets**

** **

 

 

 

 
Aesthetic and General Surgery

** $        134,490 **

 $        135,199 

** **

** **

 
Surgical Urology

**           117,803 **

            114,937  

** **

** **

 
Clinical and Consumer Healthcare

**             74,825 **

             76,695  

** **

** **

 
  Total reportable segments

** $        327,118 **

 $        326,831  

** **

** **

 
 

 

 

 

 

 
18
 
**Item 2.**

**Management's  Discussion and Analysis of Financial Condition and Results of Operations**

*CautionaryStatement:*

*The following discussion and analysis should be read in conjunction withour Unaudited Condensed Consolidated Financial Statements and related Notesthereto contained elsewhere in this Report.  The information contained inthis Quarterly Report on Form 10-Q is not a complete description of ourbusiness or the risks associated with an investment in our securities.  Weurge you to carefully review and consider the various disclosures made by us inthis Report and in our other reports filed with the Securities and ExchangeCommission (“SEC”), including our Annual Report on Form 10-Kfor the year ended March 31, 2004, and subsequent reports on Forms 10‐Qand 8‐K, which discuss our business in greater detail.*

*The section entitled “Risk Factors” set forth below, andsimilar discussions in our other SEC filings, discuss some of the importantrisk factors that may affect our business, results of operations and financialcondition.  These risks, in addition to the other information in thisReport and in our other filings with the SEC, should be carefully consideredbefore deciding to purchase, hold or sell our securities.*

*All statements included in this Report, other than statements orcharacterizations of historical fact, are forward-looking statements within themeaning of the Private Securities Litigation Reform Act of 1995.  Examplesof forward-looking statements include, but are not limited to, statementsconcerning:*
-  *ouranticipated growth strategies;* 
-  *ouranticipated sales, expenses and taxes for fiscal 2005* 
-  *our intentionto introduce or seek regulatory approval for new products;* 
-  *our abilityto continue to meet FDA and other regulatory requirements;* 
-  *our anticipated outcomes of litigation and regulatory reviews;* 
-  *our abilityto replace sources of supply without disruption or regulatory delay;* 
-  *ouraccounting estimates, assumptions and judgments, the market acceptance andperformance of our products, the competitive nature of and anticipated growthin our markets;* 
-  *our abilityto consummate acquisitions and integrate their operations successfully; and* 
-  *the need foradditional capital.* 

*These forward-looking statements are based on our current expectations,estimates and projections about our industry, management’s beliefs, andcertain assumptions made by us.  Forward-looking statements can often beidentified by words such as “anticipates,” “expects,”“intends,” “plans,” “predicts,””projects,” “believes,” “seeks,”“estimates,” “may,” “will,”“should,” “would,” “could,”“potential,” “continue,” “ongoing,” ”guidance,” and similar expressions, andvariations or negatives of these words.  In addition, any statements thatrefer to expectations, projections, forecasts or other characterizations offuture events or circumstances, including any underlying assumptions, areforward-looking statements.  These forward-looking statements speak onlyas of the date of this Report and are based upon the information available tous at this time.  Such information is subject to change, and we will notnecessarily inform you of such changes.  These statements are notguarantees of future results and are subject to risks, uncertainties andassumptions that are difficult to predict.  Therefore, our actual resultscould differ materially and adversely from those expressed in any forward-lookingstatement as a result of various factors, some of which are listed under thesection “Risk Factors” below.  We undertake no obligation torevise or update publicly any forward-looking statement for any reason.*

19

Company Overview  

Founded in 1969, we are a leading supplier of medicalproducts for the global healthcare market.  We develop, manufacture andmarket a broad range of products serving the medical specialties market. Our products are utilized by three primary segments, aesthetic and generalsurgery (plastic and reconstructive surgery), surgical urology, and clinicaland consumer healthcare.  

Our aesthetic and general surgery products includesurgically implantable prostheses for plastic and reconstructive surgery, aswell as capital equipment and consumables used for soft tissue aspiration orbody contouring (liposuction).  Our surgical urology products include surgically implantable prostheses for the treatment of impotence, surgically implantableincontinence products, urinary care products and brachytherapy seeds for thetreatment of prostate cancer.  Our clinical and consumer healthcare productsinclude catheters and other products for the management of urinary incontinenceand retention. 

We employ approximately 2,000 people around the world and areheadquartered in Santa Barbara, California, with manufacturing and researchoperations in the United States, France, the Netherlands and the UnitedKingdom.  We also purchase finished products and certain raw materialcomponents from third party manufacturers and suppliers.  The cost ofgoods sold represents raw materials, labor and overhead, and the cost of thirdparty finished products.  Gross margins may fluctuate from period to period dueto changes in the selling prices of our products, the mix of products sold,changes in the cost of third party finished products, raw materials, labor andoverhead and manufacturing efficiencies or inefficiencies. 

In addition to our strong domestic presence, we export mostof our product lines, principally to Canada, Western Europe, Central and SouthAmerica, and the Pacific Rim.  Products are sold through our directinternational sales offices in Canada, the United Kingdom, Germany, France,Japan, Benelux, Australia, Spain, Portugal and Italy, as well as throughindependent distributors in other countries.

We employspecialized domestic sales forces for our aesthetic surgery, body contouring,and urologic specialties, which includes our women's health, erectiledysfunction, prostate brachytherapy and clinical and consumer healthcareproduct lines

Ourselling, general and administrative expense incorporates the expenses of oursales and marketing organization and the general and administrative expensesnecessary to support the global corporation. Our sales and marketing expensesconsist primarily of salaries, commissions, and marketing program costs.General and administrative expenses incorporate the costs of finance, humanresources, information services, legal and insurance costs.

Ourresearch and development expenses are comprised of the following types of costsincurred in performing clinical development and research and developmentactivities: salaries and benefits, allocated overhead, clinical trial andrelated clinical manufacturing costs, regulatory costs, contract services, andother outside costs.  We also conduct research on materials technology,product design and product improvement.

20

Recent Developments  

On October 25, 2003, we completed the acquisition of InformSolutions Inc., now doing business as Mentor Practice Development Serviceslocated in San Diego, California.  Mentor Practice Development Services is a leading providerof comprehensive integrated practice management software and revenueenhancement services to the plastic surgery industry.  We paid cash for theacquisition andcommitted to several milestone payments over the ensuing three years based uponsales and earnings.  We expect that the software and consulting revenuesgenerated by Mentor Practice Development Services will not be substantial.  We do, however, generallyanticipate that the software and services Mentor Practice Development Services offers will assistour plastic surgery customers to better manage their practices, resulting in growthof our related product sales. 

On December 10, 2003 we completed a licensing agreement withthe Wisconsin Alumni Research Foundation (“WARF”), which gives usthe exclusive manufacturing and marketing rights to the proprietary botulinumtoxin technology developed at the University of Wisconsin-Madison.  Inexchange, we paid cash and committed to royalty payments based upon futuresales, and future payments based upon developmental milestones.  We do notexpect any revenues from products utilizing this technology in fiscal year 2005or fiscal year 2006, as the products will require additional research, clinicalstudies and regulatory approvals before they can be marketed.  

On December 22, 2003, we completed an offering of $150million of convertible subordinated notes due January 1, 2024 pursuant to Rule144A under the Securities Act of 1933.  The notes bear interest at23⁄4% per annum and are convertible into shares of our common stock at anadjusted conversion price of $29.27 per share and are subordinated to allexisting and future senior debt.  

**APPLICATION OF CRITICAL ACCOUNTING POLICIES**

Management's Discussion and Analysis of Financial Conditionand Results of Operations addresses our consolidated financial statements,which have been prepared in accordance with accounting principles generallyaccepted in the United States.  The preparation of these financialstatements requires us to make estimates and assumptions that affect thereported amounts of assets and liabilities, the disclosure of contingent assetsand liabilities at the date of the financial statements, and the reportedamounts of revenues and expenses during the reporting period.  On anon-going basis, we evaluate our estimates and judgments.  We base ourestimates and judgments on historical experience and on various other factorsthat are believed to be reasonable under the circumstances, the results ofwhich form the basis for making judgments about the carrying values of assetsand liabilities that are not readily apparent from other sources.  Actualresults may differ from these estimates under different assumptions orconditions.  

Management has identified the critical accounting policiesto be those related to revenue recognition, accounts receivable, inventories,warranties and related reserves, and goodwill and intangible assetimpairment.  These accounting polices are discussed in the “Management'sDiscussion and Analysis of Financial Condition and Results of Operations”and notes to the consolidated financial statements included in the Company'sAnnual Report on Form 10-K for the fiscal year ended March 31, 2004.

21

**RESULTS OF OPERATIONS**

**For the three-month period ended September 30, 2004 comparedto the three-month period ended September 30, 2003**Our quarterly results reflect slight seasonality, as thefiscal quarter ending September 30 tends to have lower breast implant revenues thanthe other three quarters.  This is primarily due to patients delayingelective surgical procedure, such as breast augmentation, until after thesummer vacation season, particularly in Europe.   

Thefollowing table sets forth certain data from the Consolidated Statements ofIncome expressed as a percentage of net sales for the periods indicated:
For the Three Months EndedFor the Six Months Ended **September 30,    2004**September 30,    2003**September 30,    2004**September 30,    2003Net sales100.0 %100.0 %100.0 %100.0 %  Cost of sales37.4 %38.1 %36.6 %37.8 %Gross profit62.6 %61.9 %63.4 %62.2 %Selling, general and administrative    expense37.3 %36.4 %36.3 %35.1 %Research and development expense7.9 %8.3 %7.2 %7.7 %Operating income17.4 %17.2 %19.9 %19.4 %Interest expense(1.3)%(0.1)%(1.1)%(0.1)%Interest income0.7 %0.3 %0.4 %0.4 %Other income (expense), net0.0 %0.3 %(0.1)%0.5 %Income before income taxes16.8 %17.7 %19.1 %6.4 %Income taxes5.3 %5.7 %6.1 %6.4 %Net income11.5 %12.0 %13.0 %13.8 %
22

**Sales**

Sales for the three-month period ended September 30, 2004increased 16.6% to $108.8 million from $93.3 million for the same quarter inthe prior year.  Foreign exchange rate movements, primarily the strengthening ofthe Euro, had a favorable year-to-year impact on international sales of $3.1million for the three-month period.  We continue to expect total sales toincrease in fiscal 2005 at a low double digit rate over sales in fiscal2004.  

Sales by Principal Product Line

For the Three Months Ended    September 30,

For the Six Months Ended   September 30,

  (in  thousands)

**2004**

  2003

Percent Change

**2004**

  2003

Percent Change

Aesthetic  & General Surgery      Products

**$   54,322**

  $   47,199

  15.1%

**$   119,866**

  $   102,702

  16.7%

Surgical  Urology Products

**30,374**

23,903

27.1%

**62,286**

51,992

19.8%

Clinical  & Consumer      Healthcare Products

**24,083**

  22,161

  8.7%

**49,059**

  43,675

  12.3%

** **

**$  108,779**

$  93,263

16.6%

**$ 231,211**

$ 198,369

16.6%

Sales of aesthetic and general surgery productsincreased 15.1% to $54.3 million for the quarter ended September 30, 2004,from $47.2 million in the same period in the prior year. Approximately $0.7million or 1.5% of this increase is attributable to the favorable impact offoreign exchange rate movements and the balance is primarily attributable toorganic growth of our silicone gel breast implants and associated products usedin reconstruction surgeries.  Total sales of breast implant productsincreased 12.2% to $46.9 million for the quarter from $41.8 million in the sameperiod in the prior year.  Increased sales were driven by strongperformance in the augmentation and reconstruction markets both domestically andinternationally. Although we try to avoid competing on price, we  continue to seecompetitive price pressure in both the domestic and international markets. Salesof body contouring products increased 10.2% to $3.9 million for the quarter from$3.5 million in the same period in the prior year.  Liposuction continuesto be the leading surgical cosmetic procedure in the United States, and sales ofour capital equipment, associated disposable products, and higher averageselling prices were the leading contributors to body contouring sales growth forthe quarter ended September 30, 2004. Although both breast implant and bodycontouring revenue increased, we believe sales were negatively impacted by thesevere weather conditions during the quarter in the Southeast United States,which is a significant market for us. Other aesthetic products sales increased87% to $3.6 million for the quarter from $1.9 million in the same period of theprior year as a result of increased revenue from physician participation in our"Extreme Makeover" direct to consumer television advertising program and revenuefrom our October 2003 acquisition of Mentor Practice Development Services.

Sales of surgical urology products increased 27.1% to $30.4million for the quarter ended September 30, 2004, from $23.9 million in thesame period in the prior year.  The reorganization of our urology salesforce, which was completed in early 2004, continues to benefit sales. Sales of women’s health care products increased 83% to $5.2 million forthe three months ended September 30, 2004 compared to $2.8 million in the prioryear. This increase was primarily attributable to our ObTapeTM slingproduct, which was introduced in the United States during August 2003 for thetreatment of stress urinary incontinence. Penile implant sales increased 8.8%to $6.2 million from $5.7 million in the comparable period of the prior yeardue to continued market acceptance of our Titan® penile devicein Europe, and to the reduction in patients sampling competitive drug therapiesfor erectile dysfunction, which had negatively impacted prior year sales. Brachytherapy product sales increased by 10.1% to $3.8 million for the quarterended September 30, 2004, from $3.4 million in the same period in the prioryear as a result of higher unit sales and improved average selling prices. Salesof our disposable urinary care products increased by $3.2 million to $15.1million for the quarter ended September 30, 2004, compared to $11.9 million inthe prior year.  Thefavorable impact of foreign exchange rate variations also increased segmentrevenue $1.4 million for the quarter ended September 30, 2004 compared to theprior year.

Sales of clinical and consumer healthcare products increased8.7% or $1.9 million to $24.1 million for the quarter ended September 30, 2004from $22.2 million in the same period of the prior year. Sales of cathetersincreased 11.6% or $1.4 million to $13.5 million for the quarter endedSeptember 30, 2004 from $12.1 million for the comparable period in the prioryear. This increase resulted from a shift to our premium product categorieswhich all have premium pricing as well as a favorable impact of foreign exchange ratevariations of $1.0 million for this segment. 

23

**Gross profit**

Gross profit increased to 62.6% of net sales for the quarter endedSeptember 30, 2004, compared to 61.9% in the comparable period in the prioryear.  Gross profit for aesthetic and general surgery products improved to74.1% of net sales, or $40.2 million for the three-month period endingSeptember 30, 2004, up from 73% of net sales in the comparable period in theprior year.  This increase in gross profit of $5.7 million is primarily attributable to manufacturing efficiencies at ourTexas and Netherlands facilities.   Gross profit for surgicalurology products improved to 54.0% of net sales for the quarter ended September30, 2004, compared to 51.4% of net sales in the same period in the prioryear.  This improvement is primarily due to increased sales ofwomen’s health care products, which have a higher gross margin than otherproducts in this segment, and the licensing of our trans-obturator method patent. Gross profitfor healthcare products decreased to 47.8% of net sales for the quarter endedSeptember 30, 2004, compared to 49.5% of net sales for the quarter ended September30, 2003. This decrease is due to manufacturing inefficiencies at our foreignmanufacturing facilities.

**Selling, General and Administrative**

Selling, general andadministrative expenses were $40.6 million, or 37.3% of net sales for thequarter ended September 30, 2004, compared to $33.9 million or 36.4% for thecomparable quarter in the prior year.  The increase as a percentage of netsales is primarily the result of increased information technology support,higher regulatory expense related to the silicone gel PMA filing, higherlegal expenses from ongoing and recently concluded litigation, recentacquisitions, and to a lesser extent increased support of sales, and our recentlylaunched direct to consumer television advertising program.  The increasein general and administrative expense was partially offsetby lower product warranty and product liability expenses.  For the fiscal yearending March 31, 2005, we expect sales, general and administrative expense tobe in the range of 35% to 37% of net sales. 

**Research and Development**

Research and developmentexpenses for the quarter ended September 30, 2004 were $8.6 million comparedto $7.7 million a year ago, or approximately 8% of net sales for each period. Research and development spending for the quarter ended September 30, 2004 wasprimarily to support key strategic product development programs including oursilicone gel breast implant PMA, the botulinum toxin program, the Hyalitedermal filler program, and the continued development of automated manufacturingtechnologies.  We expect the level of spending on research and developmentactivities to be in the range of 7% to 8% of net sales for the fiscal yearending March 31, 2005. 

**Interest and Other Income and Expense**

Interest expenseincreased approximately $1.0 million to $1.2 million for the quarter endedSeptember 30, 2004, compared to $.2 million in the same period of the prioryear.  The increase is the result of additional interest on our $150million in convertible subordinated notes issued in December 2003, carrying acoupon rate of 2 3⁄4%.  The remaining interest expense is interest onbalances outstanding under our foreign lines of credit.  

**Income Taxes**

The effective rate of corporate income taxes for thethree-months ended September 30, 2004, was 31.6% as compared to 32.0% for thecomparable period in the prior year.  We expect our effective tax rate tobe in the range of 32% to 33% for the fiscal year ending March 31, 2005.

24

**Net Income and Earnings Per Share**

Net income for the quarter ended September 30,2004 increased 11.6% to $12.5 million from $11.2 million in the comparable periodin the prior year.  Diluted earnings per share increased 21.7% to $0.28for the quarter, compared to $0.23 for the comparable period lastyear.  As a result of our stock repurchase program, we have fewer sharesoutstanding resulting in a positive impact on the year-over-year quarterlycomparison of diluted earning per share.

**For the six-month periods ended September 30, 2004 comparedto the six-month periods ended September 30, 2003.**

**Sales**

Sales increased 16.6%, or $32.8 million to $231.2 million forthe six months ended September 30, 2004, compared to $198.4 million for the sameperiod in the prior year.   Foreign exchange rate movements,primarily the strengthening of the Euro, had a favorable year-to-year impact oninternational sales of $5.9 million for the six month period.   

Sales of aesthetic and general surgery productsincreased 16.7%, or $17.2 million to $119.9 million for the six-month periodended September 30, 2004, compared to $102.7 million for the same period in theprior year.   Approximately $1.5 million of the increase isattributable to the favorable impact of foreign exchange rates and the balanceis due to organic growth in unit sales. Sales of breast implants increased $13 million or 14.2% to $104.3 million for the six months ended September 30,2004, compared to $91.3 million for the same period in the prior year. Bodycontouring product sales increased 21.1% to $8.6 million for the six-monthperiod ended September 30, 2004, from $7.1 million for the comparable period inthe prior year.  Increases in body contouring product sales are primarilyattributable to increased liposuction procedural volumes as awareness andacceptance of this procedure increases. Although both breast implant and bodycontouring revenue increased, we believe sales were negatively impacted by thesevere weather conditions during the  quarter ended September 30, 2004 in the Southeast UnitedStates, which is a significant market for us.  Other product salesincreased by 26% to $6.9 million for the six months ended September 30, 2004,compared to  $5.5 million the same period in the prior year as a result ofincreased revenue from physician participation in our  "Extreme Makeover" directto consumer television advertising program and revenue from our October 2003acquisition of Mentor Practice Development Services.

Sales of surgical urology products increased 19.8%, or $10.3million to $62.3 million for the six month period ended September 30, 2004,compared to $52 million for the same period in the prior year.  This growthprimarily resulted from the reorganization of our urology sales force, which wascompleted in early 2004 and led to improved selling focus and higher salesproductivity. The increases in sales were primarily attributable to a $5.1 millionincrease in sales of our women’s health care products and a $4.1 millionincrease in sales of our disposable urinary care products. This increase insales was primarily attributable to our ObTapeTM sling product, which wasintroduced in the United States during August 2003 for the treatment of stressurinary incontinence. Brachytherapy product sales increased 7% to $7.6 millionfor the six months ended September 30, 2004 compared to $7.1 million for thesame period in the prior year as a result of higher unit sales and improvedaverage selling prices.  Foreign exchange rate fluctuations favorably impactedsales by $2.5 million.

Sales of clinical and consumer healthcare products increased12.3%, or $5.3 million to $49 million for the six month period ended September30, 2004 compared to $43.7 million for the same period in the prior year. Sales of our catheterproducts increased $4.2 million or 18.6%to $26.8 million for the six month period ended September 30, 2004, from $22.6million for the same period of the prior year.  Sales of other disposablehomecare and ostomy products increased 5.2% to $22.2 million for the quarterended September 30, 2004, from $21.1 millionin the comparable period of the prior year.  This increase resulted from ashift to our premium product categories which all have premium pricing as wellas a favorable impact of foreign exchange rate variations of $1.9 million forthis segment.

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**Gross profit**

Gross profit for the six-months ended September 30, 2004,improved to 63.4% of net sales from 62.2% for the same period in the prioryear. Gross profit for aesthetic and general surgery products improved to 74.5%of net sales, or $89.3 million for the six-month period ending September 30,2004, up from 72.1% of net sales in the comparable six-month period in the prioryear.  This increase in gross profit of $15.3 million is primarilyattributable to manufacturing efficiencies at our Texas and Netherlands facilities. Gross profit for surgical urology products for the six-month period endedSeptember 30, 2004 improved to 53.9% of net sales compared to 52.6% of netsales for the same period in the prior year.  The improvement in the grossprofit percentage is primarily due to increased sales of women’s healthcare products, which have a higher gross margin than other products in thissegment, and the licensing of our trans-obturator method patent. Gross profit for clinical andconsumer healthcare products for the six-month period ended September 30, 2004,decreased to 48.4% of net sales compared to 50.6% in the prior year.  Thisdecrease is due to manufacturing inefficiencies at our foreign manufacturingfacilities.

**Selling, General and Administrative**

Selling, general and administrative expense increased to36.3% of net sales, or $83.8 million for the six-month period ended September30, 2004, compared to 35.1% or $69.6 million in the comparable period of theprior year.  The increase as a percentage of net sales is primarily theresult of increased information technology support,higher regulatory expense related to the silicone gel PMA filing, higherlegal expenses from ongoing and recently concluded litigation, recentacquisitions, and to a lesser extent increased support of sales, and our recentlylaunched direct to consumer television advertising program.  The increasein general and administrative expense was partially offset by lowerproduct warranty and product liability expenses.

**Research and Development**

Research and development expenses for the six-month periodended September 30, 2004 decreased from 7.7% to 7.2% as a percent of net sales,and were $16.6 million compared to $15.3 million for the comparable period ayear ago.  Research and development spending primarily supports keystrategic product development programs including our silicone gel breastimplant PMA, the botulinum toxin program, the Hyalite dermal filler program,and the continued development of automated manufacturing technologies.  Duringthe first quarter of fiscal 2005 we recorded a $0.8 million charge related tothe termination of a brachytherapy development project and related automatedmanufacturing equipment.

**Interest and Other Income and Expense**

Interest expense for the six-month period ended September30, 2004 increased to $2.6 from $0.3 million in the comparable period in theprior year.  Approximately $2.1 million of the expense relates to the $150million in convertible subordinated notes issued in December 2003 with a couponrate of 2 3⁄4%.  The remaining interest expense is interest onbalances outstanding under our foreign lines of credit.

**Income Taxes**

The effective rate of corporate income taxes for thesix-months ended September 30, 2004 was 31.9% as compared to 31.7% for thecomparable period in the prior year.  

**Net Income and Earnings Per Share**

Net income for the six-month period ended September 30, 2004increased 10.6% to $30.2 million from $27.3 million in the comparable period inthe prior year.  Diluted earnings per share increased 19.6% to $.67 forthe six-month period compared to $0.56 for the comparable period lastyear.  As a result of our stock repurchase program, we have fewer sharesoutstanding, resulting in a positive impact on the year over year six monthcomparison of diluted earning per share.

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**LIQUIDITY AND CAPITAL RESOURCES**

Our balance sheet reflectedcash, cash equivalentsand short-term marketable securities of $128 million at September 30, 2004,compared to $118 million at March 31, 2004.  During the first quarter offiscal 2005 we invested  $25 million of cash into long-term marketablesecurities, primarily Federal Home Loan Bank and Federal National MortgageAssociation notes to increase our interest income on our cash reserves.  Ourcash provided by operating activities and the proceeds of our convertible noteshas been our primary recurring source of funds, and this is expected tocontinue.  Our working capital was $210 million at September 30, 2004,compared to $198 million at March 31, 2004.  We generated $46 million ofcash from operating activities during the six months ended September 30, 2004,compared to $27 million during the same period the previous year. Approximately $3 million of the increase was attributable to increased net income,$1.5 million was attributable to additional amortization and depreciationexpense and $1.7 million was attributable to non-cash losses on asset disposals for the six-month period endedSeptember 30, 2004.  The timing of income tax payments added $5 million tooperating cash flows and an increase in accounts payable and accruedliabilities added approximately $8 million for the six months ended September30, 2004, compared to the same period in the prior year.  

During the six months endedSeptember 30, 2004, we invested approximately $4.8 million in property andequipment, primarily for production equipment purchases.  We anticipate additionalinvestments of approximately $10 million during the remainder of fiscal 2005 tocontinue facility improvements and to purchase production equipment. 

We receive cash from theexercise of employee stock options.  Employee stock option exercisesprovided $9.6 million of cash during the six months ended September 30, 2004compared to $6.6 million in the same period the previous year.  Proceedsfrom the exercise of employee stock options will vary from period to periodbased primarily upon fluctuations in the market value of our common sharesrelative to the exercise price of such options, among other factors. 

We have a stock repurchase program, primarily to offset thedilutive effect of our employee stock option program, to provide liquidity tothe market, and to reduce the overall number of shares outstanding.  Allshares repurchased under the program are retired and are no longer deemed to beoutstanding.  At September 30, 2004, 3.6 million shares remainedauthorized for repurchase.  The timing of repurchases is subject to marketconditions, cash availability, and blackout periods during which we are restricted from repurchasing shares. There is no guarantee that shares authorized for repurchase by the Board willultimately be repurchased.  There were no share repurchases under this programfor the six month period ending September 30, 2004. 

In January 2001, we completed the acquisition of the assetsof South Bay Medical, LLC.  The total consideration included $2 million incash, 470,586 restricted shares of our common stock having a fair market valueof $4 million, and $13.6 million to be paid in cash or our common stock overthe next several years.  These future payments are recorded as anacquisition obligation payments liability of $11.4 million at September 30,2004.  Approximately $5.9 million of the future acquisition obligationpayments is to be paid in shares of our common stock valued at fair marketvalue on the date of issuance, over several years based on the achievement ofunit sale milestones. 

In December 2001, we entered into several agreements withProsurg, Inc. to purchase certain patent rights and to secure a supply ofproduct.  The total consideration included $2.0 million in cash and $1.7million in short and long-term payments due over the next several years. The future payments have been recorded as an acquisition obligation liabilityat net present value and will increase with imputed interest to $2.0 million,due over the next several years, based on the achievement of certainmilestones.  

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On September 9, 2003, we entered into several transactionsto acquire from AMI, LLC, the exclusive license, marketing and distributionrights for certain product technology, and intellectual property rights, as wellas, a related supply agreement with Prosurg,Inc.  We have paid $4.5 million in cash and issued 133,630 restricted sharesof our common stock valued at fair market value of $3 million.  Weanticipate making additional payments of $3.0 million upon the completion ofcertain developmental and regulatory milestones, expected to be achieved overthe next several years. 

On October 25, 2003, we acquired Inform Solutions, Inc.,now doing business as Mentor Practice Development Services, fortotal consideration of $3 million in cash.  The agreement commits us tomake additional payments totaling up to $1.7 million based upon achievement offuture sales and earnings thresholds over 3 years. 

On December 22, 2003, we completed an offering of $150million of convertible subordinated notes due January 1, 2024 pursuant to Rule144A under the Securities Act of 1933.  The notes bear interest at23⁄4% per annum and are convertible into shares of our common stock at anadjusted conversion price of $29.27 per share and are subordinated to allexisting and future senior debt.  Concurrent with the issuance of theconvertible subordinated notes, we entered into a convertible bond hedge andwarrants transactions with respect to our common stock, the exposure for whichis held by Credit Suisse First Boston LLC for a net cash payment of $18.5million.  Both the bond hedge and the warrants transactions may be settledat our option either in cash or net shares and expire January 1, 2009. The convertible bond hedge and warrants transactions combined are intended toreduce the potential dilution from conversion of the notes by effectivelyincreasing the conversion price per share to $39.43. 

In September 2004, the Board of Directorsincreased the quarterly dividend rate from $.15 per share to $.17 per share. It is our intent to continue to pay dividends for the foreseeable future subjectto, among other things, Board approval, cash availability, debt restrictions andalternative cash needs.  At the current annualdividend rate of $.68 per share, the aggregate annual dividend would beapproximately $28 million. 

We had a secured line ofcredit for borrowings up to $25 million ("Credit Agreement"), whichaccrued interest at the prevailing prime rate or 1.75% over LIBOR, at ourdiscretion.  The Credit Agreement expired in September 2004 and we arecurrently renegotiating a new agreement which we expect will have similarterms.  The Credit Agreement included certain covenants that, among otherthings, limited the dividends we could pay and required maintenance of certainlevels of tangible net worth and debt service ratios.  At September 30,2004, we had three commercial letters of credit totaling $2.0 million.

Inaddition, in February 2001, we established several lines of credit with localforeign lenders to facilitate operating cash flow needs at our foreignsubsidiaries.  These credit lines are at market rates of interest,unsecured, are guaranteed by us, and total $7.1 million, of which $5.4 millionwas outstanding, and $1.7 million was available at September 30, 2004. 

In fiscal2002, we established a line of credit of $6.5 million to finance theconstruction of a new facility in Leiden, the Netherlands.  The borrowingsaccrue interest at EURIBOR plus 0.75% and are secured by the new facility andother assets in The Netherlands.  At September 30, 2004, $4 million wasoutstanding and $2.5 million was available under this line. 

At September 30, 2004, ourtotal short-term borrowings under all lines of credit were $9.4 million and theweighted-average interest rate was 2.99%.  The total amount of additionalborrowings available to us under all lines of credit was $4.2 million and $28.1million at September 30, 2004 and March 31, 2004, respectively.  

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We enterinto various product and intellectual property acquisitions and businesscombinations.  In connection with some of these activities, we agree tomake payments to third parties when specific milestones are achieved, such asreceipt of regulatory approvals or achievement of performance or operationaltargets.  

We do nothave any off-balance sheet arrangements that are currently material or reasonablylikely to be material to our financial position or results of operations. 

Our principal source ofliquidity at September 30, 2004 consisted of $128 million in cash, cashequivalents and short-term marketable securities, plus $35 million of highlyliquid marketable securities accounted for as long term assets, plus $6.2million available under our existing lines of credit.  We believe thatfunds generated from operations, our cash, cash equivalents and marketablesecurities and funds available under line of credit agreements will be adequateto meet our working capital needs and capital expenditure investmentrequirements and commitments for the foreseeable future.  However, it ispossible that we may need to raise additional funds to finance unforeseen requirementsor to consummate acquisitions of other business, products ortechnologies.  Additional funds could be raised by selling equity or debtsecurities to the public or to selected investors, or by borrowing money fromfinancial institutions.  In addition, even though we may not needadditional funds, we may still elect to sell additional equity or debtsecurities or obtain credit facilities for other reasons.  We may not beable to obtain additional funds on terms that would be favorable to us, or atall.  If funds are raised by issuing additional equity securities orconvertible debt securities, the ownership percentage of existing shareholderswould be reduced.  In addition, the equity or debt securities issued by usmay have rights, preferences or privileges senior to those of our common stock.

**RiskFactors**

**Forward-Looking Information Under the Private SecuritiesLitigation Reform Action of 1995**

The Private Securities Litigation Reform Act of 1995provides a "safe harbor" for forward-looking statements.  TheAct was designed to encourage companies to provide prospective informationabout them without fear of litigation.  The prospective information mustbe identified as forward-looking and must be accompanied by meaningfulcautionary statements identifying important factors that could cause actualresults to differ materially from those projected in the statements.  Thestatements about our business, plans, strategies, intentions, expectations andprospects contained throughout this document are based on currentexpectations.  These statements are forward-looking and actual results maydiffer materially from those predicted as of the date of this report in theforward-looking statements, which involve risks and uncertainties.  Inaddition, past financial performance is not necessarily a reliable indicator offuture performance and investors should not use historical performance toanticipate results or future period trends.  We undertake no obligation torevise or update publicly any forward-looking statements for any reason, evenif new information becomes available or other events occur in the future.

Our business faces many risks.  The risks describedbelow may not be the only risks we face.  Additional risks that we do notyet know of or that we currently think are immaterial may also impair ourbusiness operations.  If any of the events or circumstances described inthe following risks actually occurs, our business, financial condition orresults of operations could suffer and the trading price of our common stock orour convertible notes could decline. You should consider the following risks beforedeciding to invest in our common stock or convertible notes. 

***Significant product liability claims or product recalls mayforce us to pay substantial damage awards and other expenses that could exceedour accruals and insurance coverage.***

The manufacture and sale of medical devices exposes us tosignificant risk of product liability claims.  In the past, and currently,we have had a number of product liability claims relating to our products, andwe may be subject to additional product liability claims in the future, some ofwhich may have a negative impact on our business.  If a product liabilityclaim or series of claims is brought against us for uninsured liabilities or inexcess of our insurance coverage, our business could suffer.  Somemanufacturers that suffered such claims in the past have been forced to ceaseoperations or even to declare bankruptcy. Additionally, we could experience a materialdesign or manufacturing failure in our products, a quality system failure,other safety issues, or heightened regulatory scrutiny that would warrant arecall of some of our products and could result in exposure to additionalproduct liability claims. 

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***We are subject to substantial government regulation, whichcould materially adversely affect our business.***

The production and marketing of our products and our ongoingresearch and development, pre-clinical testing and clinical trial activitiesare subject to extensive regulation and review by numerous governmentalauthorities both in the U.S. and abroad.  Most of the medical devices wedevelop must undergo rigorous pre-clinical and clinical testing and anextensive regulatory approval process before they can be marketed.  Thisprocess makes it longer, more difficult and more costly to bring our productsto market, and we cannot guarantee that any of our products will beapproved.  The pre-marketing approval process can be particularlyexpensive, uncertain and lengthy, and a number of devices for which FDAapproval has been sought by other companies have never been approved formarketing.  In addition to testing and approval procedures, extensiveregulations also govern marketing, manufacturing, distribution, labeling, andrecord-keeping procedures.  If we do not comply with applicable regulatoryrequirements, such violations could result in non-approval, suspensions ofregulatory approvals, civil penalties and criminal fines, product seizures andrecalls, operating restrictions, injunctions, and criminal prosecution. 

Delays in, withdrawal, or rejection of FDA or othergovernment entity approval of our products, may also adversely affect ourbusiness.  Such delays or rejection may be encountered due to, among otherreasons, government or regulatory delays, lack of efficacy during clinicaltrials, unforeseen safety issues, slower than expected rate of patientrecruitment for clinical trials, inability to follow patients after treatmentin clinical trials, inconsistencies between early clinical trial results andresults obtained in later clinical trials, varying interpretations of datagenerated by clinical trials, or changes in regulatory policy during the periodof product development in the U.S. and abroad.  In the U.S., there hasbeen a continuing trend of more stringent FDA oversight in product clearanceand enforcement activities, causing medical device manufacturers to experiencelonger approval cycles, greater risk and uncertainty, and higher expenses. Internationally,there is a risk that we may not be successful in meeting the quality standardsor other certification requirements.  Even if regulatory approval of aproduct is granted, such approval may entail limitations on uses for which theproduct may be labeled and promoted, or may prevent us from broadening the usesof our current products for different applications.  In addition, we maynot receive FDA approval to export our products in the future, and countries towhich products are to be exported may not approve them for import. 

Our manufacturing facilities also are subject to continualgovernmental review and inspection.  The FDA has stated publicly thatcompliance with manufacturing regulations will be scrutinized morestrictly.  A governmental authority may challenge our compliance withapplicable federal, state and foreign regulations.  In addition, anydiscovery of previously unknown problems with one of our products or facilitiesmay result in restrictions on the product or the facility, including withdrawalof the product from the market or other enforcement actions. 

From time to time, legislative or regulatory proposals areintroduced that could alter the review and approval process relating to medicaldevices.  It is possible that the FDA or other governmental authoritieswill issue additional regulations which would further reduce or restrict thesales of our present or proposed products.  Any change in legislation orregulations that govern the review and approval process relating to our currentand future products could make it more difficult and costly to obtain approvalfor new products, or to produce, market, and distribute existing products.

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***If we are unable to continue to develop and commercializenew technologies and products, we may experience a decrease in demand for ourproducts or our products could become obsolete****.*

The medical device industry is highly competitive and issubject to significant and rapid technological change.  We believe thatour ability to develop or acquire new technologies is crucial to oursuccess.  We are continually engaged in product development, improvementprograms and required clinical studies to maintain and improve our competitiveposition.  Any significant delays in the above or termination of ourclinical trials would materially and adversely affect our development andcommercialization timelines.  We cannot guarantee that we will besuccessful in enhancing existing products, or in developing or acquiring newproducts or technologies that will timely achieve regulatory approval.  

There is also a risk that our products may not gain marketacceptance among physicians, patients and the medical communitygenerally.  The degree of market acceptance of any medical device or otherproduct that we develop will depend on a number of factors, includingdemonstrated clinical safety and efficacy, cost-effectiveness, potentialadvantages over alternative products, and our marketing and distributioncapabilities.  Physicians will not recommend our products if clinical andother data or other factors do not demonstrate their safety and efficacycompared to other competing products, or if our products do not best meet theparticular needs of the individual patient.

Our products compete with a number of other medical productsmanufactured by major companies, and may also compete with new productscurrently under development by others.  On January 8, 2004 the FDAreleased new Draft Guidance for Saline, Silicone Gel, and Alternative BreastImplants.  This new draft guidance has additional requirements from theFDA's previously issued guidance document dated February 2003.  Wecompleted our PMA application to the FDA for the pre-market approval for oursilicone gel-filled implants for breast augmentation, reconstruction andrevision in December 2003, using the earlier guidance document provided by theFDA.  The FDA has indicated that our PMA "is sufficiently complete topermit a substantive review and is, therefore, suitable for filing." Any change in FDA guidance, such as that announced on January 8thby the FDA, may delay or may otherwise adversely affect our application or itsreview or approval by the FDA.  A delay, denial, or "notapprovable" response by the FDA would have a material adverse affect onour commercialization timelines, competitive position and ultimately ourrevenue and operating results.  In August we amended our PMA based on theFDA draft guidance and responded to other issues raised by the FDA. We continueto address their questions and the process may require substantial time andexpense based on the nature of the questions with no assurances of success. Ifour competitor gains FDA approval to market its competitive products before wedo, our competitive position may suffer.  If our new products do notachieve significant market acceptance, or if our current products are not ableto continue competing successfully in the changing market, our sales andearnings may not grow as much as expected, or may even decline. 

***If we suffer negative publicity concerning the safety of ourproducts, our sales may be harmed and we may be forced to withdraw products.***

Physicians and potential patients may have a number ofconcerns about the safety of our products, including our breast and otherimplants, whether or not such concerns have a basis in generally acceptedscience or peer-reviewed scientific research.  Negative publicity-whetheraccurate or inaccurate-concerning our products could reduce market orgovernmental acceptance of our products and could result in decreased productdemand or product withdrawal.  In addition, significant negative publicitycould result in an increased number of product liability claims, whether or notthese claims are supported by applicable law. 

***If changes in the economy and consumer spending reduceconsumer demand for our products, our sales and profitability could suffer.***

Certain elective procedures, such as breast augmentation,body contouring, and surgical treatment for male impotence are typically notcovered by insurance.  Adverse changes in the economy may cause consumersto reassess their spending choices and reduce the demand for these surgeriesand could have an adverse effect on consumer spending.  This shift couldhave an adverse effect on our sales and profitability. 

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***If we are unable to implement new information technologysystems, our ability to manufacture and sell products, maintain regulatorycompliance and manage and report our business activities may be impaired,delayed or diminished, which would cause substantial business interruption andloss of sales, customers and profits.***

We are in the process of implementing an enterprise resourceplanning system that will be our primary business management system for nearlyall of our businesses worldwide.  Many other companies have had severeproblems with computer system implementation of this nature and scope.  Weare using a controlled project plan and we believe we have assigned adequatestaffing and other resources to the project to ensure its successful implementation;however there is no assurance that the design will meet our current and futurebusiness needs or that it will operate as designed.  We are heavilydependent on such computer systems, and any failure or delay in the systemimplementation would cause a substantial interruption to our business,additional expense, and loss of sales, customers, and profits. 

***If we are unable to acquire companies, businesses ortechnologies as part of our growth strategy or to successfully integrate pastacquisitions, our growth, sales and profitability could suffer.***

A significant portion of our recent growth has been theresult of acquisitions of other companies, businesses and technologies. We intend to continue to acquire other businesses and technologies to facilitateour future business strategies, although there can be no assurance that we willbe able to identify appropriate acquisition candidates, consummate transactionsor obtain agreements with terms favorable to us.  Further, once a businessis acquired, any inability to integrate the business, failure to retain anddevelop its workforce, or establish and maintain appropriate communications,performance expectations, regulatory compliance procedures, accountingcontrols, and reporting procedures could adversely affect our future sales andearnings.

***If our intellectual property rights do not adequatelyprotect our products or technologies, others could compete against us moredirectly, which would hurt our profitability.***

Our success depends in part on our ability to obtain patentsor rights to patents, protect trade secrets, operate without infringing uponthe proprietary rights of others, and prevent others from infringing on ourpatents, trademarks and other intellectual property rights.  We will be ableto protect our intellectual property from unauthorized use by third partiesonly to the extent that it is covered by valid and enforceable patents,trademarks or licenses.  Patent protection generally involves complexlegal and factual questions and, therefore, enforceability of patent rightscannot be predicted with certainty; thus, any patents that we own or licensefrom others may not provide us with adequate protection againstcompetitors.  Moreover, the laws of certain foreign countries do not recognizeintellectual property rights or protect them to the same extent as do the lawsof the United States.  

In addition to patents and trademarks, we rely on tradesecrets and proprietary know-how.  We seek protection of these rights, inpart, through confidentiality and proprietary information agreements. These agreements may not provide sufficient protection or adequate remedies forviolation of our rights in the event of unauthorized use or disclosure ofconfidential and proprietary information.  Failure to protect ourproprietary rights could seriously impair our competitive position. 

***If third parties claim we are infringing their intellectualproperty rights, we could suffer significant litigation or licensing expensesor be prevented from marketing our products.***

Our commercial success depends significantly on our abilityto operate without infringing the patents and other proprietary rights ofothers.  However, regardless of our intent, our technologies may infringeupon the patents or violate other proprietary rights of third parties.  Inthe event of such infringement or violation, we may face expensive litigationand may be prevented from selling existing products and pursuing productdevelopment or commercialization. 

***We depend on single and sole source suppliers for certainraw materials and licensed or manufactured products and the loss of anysupplier could adversely affect our ability to manufacture or sell many of ourproducts.***

We currently rely on single or sole source suppliers for rawmaterials, including silicone, used in many of our products.  In the eventthat they cannot meet our requirements, we cannot guarantee that we would beable to obtain a sufficient amount of quality raw materials in a timelymanner.  We also depend on third party manufacturers for components andlicensed products, including our women's health products and our palladiumbrachytherapy seed product.  If there is a disruption in the supply ofthese products, our sales and profitability would be adversely affected. 

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***Our international business exposes us to a number of risks.***

More than one-third of our sales are derived frominternational operations.  Accordingly, any material decrease in foreignsales would have a material adverse effect on our overall sales andprofitability. Most of our international sales are denominated in Euros,British Pounds, Canadian Dollars or U.S. Dollars.  Depreciation ordevaluation of the local currencies of countries where we sell our products mayresult in our products becoming more expensive in local currency terms, thusreducing demand, which could have an adverse effect on our operatingresults.  Our operations and financial results may be adversely affectedby other international factors, including: 
- foreigngovernment regulation of medical devices; 
- product liability, intellectual property and  other claims; 
- new export license requirements; 
- political or economic instability in our  target markets; 
- trade restrictions; 
- changes in tax laws and tariffs; 
- managing foreign distributors and  manufacturers; 
- managing foreign branch offices and staffing;  and 
- competition. 

***Health care reimbursement or reform legislation couldmaterially affect our business.***

If any national health care reform or other legislation orregulations are passed that imposes limits on the amount of reimbursement forcertain types of medical procedures or products, or on the number or type ofmedical procedures that may be performed, or that has the effect of restrictinga physician's ability to select specific products for use in patientprocedures, such changes could have a material adverse effect on the demand forour products.  Our revenues depend largely on U.S. and foreign governmenthealth care programs and private health insurers reimbursing patients' medicalexpenses.  Physicians, hospitals, and other health care providers may notpurchase our products if they do not receive satisfactory reimbursement fromthese third-party payers for the cost of procedures using our products. In the U.S., there have been, and we expect that there will continue to be, anumber of federal and state legislative and regulatory proposals to implementgreater governmental control over the healthcare industry and its relatedcosts.  These proposals create uncertainty as to the future of ourindustry and may have a material adverse effect on our ability to raise capitalor to form collaborations.  In a number of foreign markets, the pricingand profitability of healthcare products are subject to governmental influenceor control.  In addition, legislation or regulations that imposerestrictions on the price that may be charged for healthcare products ormedical devices may adversely affect our sales and profitability. 

***If our use of hazardous materials results in contaminationor injury, we could suffer significant financial loss.***

Our manufacturing and research activities involve thecontrolled use of hazardous materials.  We cannot eliminate the risk ofaccidental contamination or injury from these materials.  In the event ofan accident or environmental discharge, we may be held liable for any resultingdamages, which may exceed our financial resources and any applicable insurance coverages.

***Future changes in financial accounting standards may causeadverse unexpected revenue or expense fluctuations and affect our reportedresults of operations.***

A change in accounting standards could have asignificant effect on our reported results and may even affect our reporting oftransactions completed before the change is effective.  The FinancialAccounting Standards Board ("FASB") has issued a Proposed Statement of FinancialAccounting Standards ("SFAS"), Share-Based Payment, anamendment of FASB Statements Nos. 123 and 95 ("ExposureDraft").  The Exposure Draft would eliminate the ability to accountfor share-based compensation transactions using Accounting Principles Board("APB") Opinion No. 25, Accounting for Stock Issued toEmployees, and generally would require that such transactions be accounted for usinga fair-value-based method, and the resulting cost recognized in the financialstatements.  The approval of this Exposure Draft or any changes requiringthat we record compensation expense in the statement of operations for employeestock options using the fair value method could have a significant negativeeffect on our reported results.  New pronouncements and varyinginterpretations of existing pronouncements have occurred and may occur in thefuture.  Changes to existing rules or current practices may adverselyaffect our reported financial results of our business. 

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***Our reported earnings per share may be more volatile becauseof the contingent conversion provision of the notes.***

Holders of our 23⁄4% convertible notes are entitled toconvert the notes into our common stock during any fiscal quarter prior toJanuary 1, 2019, if the closing price of our common stock for at least 20trading days in the 30 consecutive trading day period ending on the firsttrading day of such fiscal quarter is more than $35.15, if we have called the notesfor redemption, or upon other specified events.  Until one of thesecontingencies is met, the shares underlying the notes are not included in thecalculation of our basic or diluted earnings per share.  Should acontingency be met, diluted earnings per share would be expected to decrease asa result of the inclusion of the underlying shares in the diluted earnings pershare calculation.  Volatility in our common stock price could cause thiscondition to be met in one quarter and not in a subsequent quarter, increasingthe volatility of our diluted earnings per share. 

***Hedging transactions and other transactions may affect thevalue of the notes.***

In connection with the original issuance of our 23⁄4%convertible notes in December 2003, we entered into convertible note hedge andwarrant transactions with respect to our common stock with Credit Suisse FirstBoston International, an affiliate of Credit Suisse First Boston LLC, theinitial purchaser of the notes, to reduce the potential dilution fromconversion of the notes up to a price of our common stock of $39.43 pershare.  In connection with these hedging arrangements, Credit Suisse FirstBoston International, and/or its affiliates, has taken and, we expect, willcontinue to take positions in our common stock in secondary market transactionsand/or will enter into various derivative transactions.  Such hedgingarrangements could adversely affect the market price of our common stock. In addition, the existence of the notes may encourage short selling in ourcommon stock by market participants because the conversion of the notes coulddepress the price of our common stock. 

***Litigation may harm our business or otherwise distract ourmanagement.***

Substantial, complex or extended litigation could cause usto incur large expenditures and distract our management, and could result insignificant monetary or equitable judgments against us.  For example,lawsuits by employees, patients, customers, licensors, licensees, suppliers,distributors, stockholders, or competitors could be very costly and couldsubstantially disrupt our business.  Disputes from time to time with suchcompanies or individuals are not uncommon, and we cannot assure that we willalways be able to resolve such disputes out of court or on terms favorable tous. 

***Our publicly-filed SEC reports are reviewed by the SEC fromtime to time and any significant changes required as a result of any suchreview may result in material liability to us and have a material adverse impacton the trading price of our common stock.***

The reports of publicly-traded companies are subject toreview by the SEC from time to time for the purpose of assisting companies incomplying with applicable disclosure requirements and to enhance the overalleffectiveness of companies public filings, and comprehensive reviews by the SECof such reports are now required at least every three years under theSarbanes-Oxley Act of 2002.  SEC reviews often occur at the time companiesfile registration statements such as the registration statement we filed inconnection with our convertible note offering, but reviews may also beinitiated at any time by the SEC.  While we believe that our previouslyfiled SEC reports comply, and we intend that all future reports will comply inall material respects with the published rules and regulations of the SEC, wecould be required to modify or reformulate information contained in priorfilings as a result of an SEC review.  Any modification or reformulationof information contained in such reports could be significant and result inmaterial liability to us and have a material adverse impact on the tradingprice of our common stock. 

34

***Our operating results may fluctuatesubstantially, and could precipitate unexpected movement in the price of ourcommon stock and convertible notes.*** 

Our common stock trades on the New York StockExchange under the symbol "MNT."  On September 30, 2004, the closing price of our commonstock on the New York Stock Exchange was $34.29 per share.  On December22, 2003, we completed an offering of $150 million of convertible subordinatednotes ("notes") due January 1, 2024 pursuant to Rule 144A under theSecurities Act of 1933.  The notes bear interest at 23⁄4% per annum,are convertible into shares of our common stock at an adjusted conversion priceof $29.27 per share and are subordinated to all existing and future seniordebt.  The market prices of our stock and convertible securities aresubject to significant fluctuations in response to the factors set forth aboveand other factors, many of which are beyond our control such as changes inpricing policies by our competitors and the timing of significant orders andshipments.  

Such factors, as well as other economic conditions, mayadversely affect the market price of our securities, including our common stockand the notes.  There could be periods in which we experience shortfallsin revenue and/or earnings from levels expected by securities analysts andinvestors, which could have an immediate and significant adverse effect on thetrading price of our securities, including our common stock and our convertiblenotes.

35

 

**Item 3.**

**Quantitative And  Qualitative Disclosures About Market Risk**

There have been no material changes in our exposure tomarket risk as reported in Item 7A in our Annual Report on Form 10-K for thefiscal year ended March 31, 2004.

**Item 4.**

**Controls and Procedures**

We maintaindisclosure controls and procedures (as defined in Rules 13a-15(e) and15d-15(e) under the Securities Exchange Act of 1934, as amended (the"Exchange Act")) that are designed to ensure that informationrequired to be disclosed in our reports filed under the Exchange Act, isrecorded, processed, summarized and reported within the time periods specified inthe SEC's rules and forms, and that such information is accumulated andcommunicated to our management, including our Chief Executive Officer and ChiefFinancial Officer, as appropriate, to allow timely decisions regarding requireddisclosure.  In designing and evaluating the disclosure controls andprocedures, management recognized that any controls and procedures, no matterhow well designed and operated, can provide only reasonable assurance ofachieving the desired control objectives, and management necessarily wasrequired to apply its judgment in evaluating the cost-benefit relationship ofpossible controls and procedures.

We carriedout an evaluation under the supervision and with the participation ofmanagement, including our Chief Executive Officer and Chief Financial Officer,of the effectiveness of the design and operation of our disclosure controls andprocedures as of September 30, 2004, the end of the period covered by thisreport.  Based on that evaluation, our Chief Executive Officer and Chief FinancialOfficer concluded that our disclosure controls and procedures were effective atthe reasonable assurance level as of September 30, 2004.

There havebeen no changes in our internal control over financial reporting (as defined inRules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter endedSeptember 30, 2004 that materially affected, or are reasonably likely tomaterially affect, our internal control over financial reporting.

36

**PART II – OTHER INFORMATION**

**Item 1.    Legal Proceedings**

In February 2004, we filed a patent  infringement suit in the United States District Court for the District of  Minnesota against American Medical Systems, Inc. ("AMS").  The suit alleged that AMS was inducing infringement and contributing to the infringement of our  United States Patent No. 6,638,211 B2 ("211 Patent"), a patent  involving a method for the treatment of urinary incontinence in women, by AMS  offering for sale and selling its Monarc Subfacial Hammock in the United  States.  The suit sought compensatory and treble damages.   AMS subsequently served us with a Complaint for declaratory judgment,  which AMS had filed earlier in the same District  Court, seeking a declaration that AMS did not infringe any valid  claim of the '211 Patent and that the claims of the '211 Patent were invalid  and unenforceable against AMS.  Because the cases involved the same  facts, they were assigned to the same judge.  On September 13,  2004, during the early stages of the litigation, we entered into a  settlement agreement with AMS under which both parties agreed to  dismiss their respective lawsuits.  Under the settlement agreement,  the parties agreed to concurrently enter into a non-exclusive cross-license  agreement covering patents and patent applications related to the field of  female pelvic health.  Under the cross-license agreement, AMS made a  one-time payment to us in the amount of $2.5 million for access  to the '211 Patent.

On March 4, 2004, John H. Alico,  et. al., d/b/a PTF Royalty Partnership ("PTF") filed a lawsuit  against us in the Business Litigation Session of the Superior Court of  Massachusetts, Suffolk County in which PTF alleges, among other things,  breach of a merger agreement that involved our acquisition of Mentor O&O,  Inc. ("O&O"), an unrelated entity at that time, which was dated  as of March 14, 1990 ("Merger Agreement") (prior to the merger,  O&O had no affiliation with us).  PTF alleges that we breached the  terms of the Merger Agreement by failing to exert commercially reasonable and  diligent efforts to obtain approval by the FDA for a product used for the  treatment of urinary incontinence and by failing to accurately account for  and pay royalties due thereunder.  PTF seeks damages in excess of $18  million, which is the maximum amount of royalties PTF could have received  under the Merger Agreement.  After almost ten years, in or about January  2001, we elected to discontinue pursuing FDA approval for the product, given  the FDA's repeated and ongoing concerns regarding the product's use for  urinary incontinence.  We believe we complied with all of our obligations under the  Merger Agreement, which specifically provided that we were under no  obligation to engage in efforts or expenditures in respect of the product  which we in good faith deemed to be inadvisable based on various factors.   Accordingly, we intend to vigorously defend the lawsuit.  Dr. Richard  Young, a member of our Board of Directors since March 1990, is a partner of PTF and is a named plaintiff in the above action.  Dr. Young was a  shareholder and principal of O&O prior to the merger and was instrumental  in facilitating the transition after the merger.

In  addition, in the ordinary course of our business we experience other varied  types of claims that sometimes result in litigation or other legal  proceedings.  Although there can be no certainty, we do not anticipate  that any of these proceedings will have a material adverse effect on us. 

**Item 2.    Unregistered Sales of Equity  Securities and Use of Proceeds**

None. 

**Item 3.    Defaults Upon Senior  Securities**

None. 

37

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

At the  Company's 2004 Annual Meeting of Shareholders held on September 15, 2004, the  following proposals were presented :

(1)   A proposal to  increase the number of directors by four from seven to eleven. The proposal  received 39,594,478 votes for, and 76,852 against ratification. There were  114,450 abstentions and four broker non-votes. 

(2)      The proposal to  elect the following individuals to the Board of Directors of the Company to  serve until the next annual meeting, or until their successors are elected, was  approved as follows:
Name of DirectorVotes ForVotes WithheldChristopher J. Conway39,149,785216,610Walter W. Faster37,202,4752,163,920Eugene G. Glover38,896,303470,092Michael Nakonechny37,213,4682,152,927Ronald J. Rossi37,235,1302,131,265Jeffrey W. Ubben37,247,3952,119,000Dr. Richard W. Young22,627,10116,739,294Michael L. Emmons39,258,104108,291Joshua H. Levine39,137,431228,964Adel Michael39,119,867246,528Joseph E. Whitters39,262,391104,004
(3)      A proposal to  ratify the appointment of Ernst & Young LLP to act as independent  auditors of the Company for the fiscal year ending March 31, 2005 was  approved.  The proposal received 39,258,476 votes for, and 477,511  against ratification.  There were 46,797 abstentions and no broker  non-votes.**Item 5.    Other Information**None. **Item 6.    Exhibits**

10.1         Employment Agreement dated August 5, 2004, between Mentor Corporation and  David Adornetto.

10.2         Employment  Agreement  dated August 5, 2004, between Mentor Corporation and A. Chris Fawzy. 

10.3          Form of Mentor  Corporation Option Agreement.

10.4          Written Description of Directors Fees Pursuant to Item 601(b)(10)(iii)(A) of  Regulation S-K.

10.5          Written Description of Incentive Bonus Plans.

10.6          Written Description of Car Allowance Plan

31.1         Certification of  Principal Executive Officer Pursuant To  Section 302 of The Sarbanes-Oxley Act of 2002.  31.2         Certification of Principal Financial Officer Pursuant To  Section 302 of The Sarbanes-Oxley Act of 2002.

32.1         CEO Certification  Pursuant To 18 U.S.C. Section 1350,  As Adopted Pursuant To Section 906 of The Sarbanes-Oxley Act                 of 2002,  filed herewith.  32.2         CFO Certification Pursuant To 18 U.S.C. Section 1350,     As Adopted Pursuant To Section 906 of The Sarbanes-Oxley Act                of 2002,  filed herewith.

38

**SIGNATURES**

Pursuant to therequirements of the Securities Exchange Act of 1934, the registrant has dulycaused this report to be signed on its behalf by the undersigned thereunto dulyauthorized.

**MENTOR CORPORATION**

(Registrant)

Date:

November 5, 2004

By:

/S/JOSHUA H. LEVINE  Joshua H. Levine  Chief Executive Officer

Date:

November 5, 2004

By:

/S/LOREN L .MCFARLAND  Loren L. McFarland  Chief Financial Officer
            
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