EX-99 2 k8aug0607financialsandpr.htm PRESS RELEASE Mentor Corporation - Press Release

MENTOR REPORTS FIRST QUARTER FISCAL YEAR 2008 FINANCIAL RESULTS
AND PROVIDES UPDATED FISCAL YEAR 2008 GUIDANCE

•     Net Sales were $95.6 Million in the First Quarter of Fiscal Year 2008, an increase of 20 percent over $79.4 Million
in the First Quarter of Fiscal Year 2007

 

•     Diluted Earnings per Share from Continuing Operations were $0.48 in the First Quarter of Fiscal Year 2008, an
increase of 45% over $0.33 per share in the First Quarter of Fiscal Year 2007

•     Premarket Approval Applications for Dermal Fillers Puragen™ Plus and Prevelle™ Plus submitted at the end of July

Santa Barbara, California, August  6, 2007 - Mentor Corporation (NYSE:MNT), a leading supplier of aesthetic medical products in the United States and internationally, today announced financial results for the first quarter of fiscal year 2008 ending June 30, 2007. 

"We are very pleased with our financial results for the first quarter and the notable progress within our R&D pipeline," commented Joshua H. Levine, President and Chief Executive Officer. "From a strategic standpoint, the acquisition of Perouse Plastie at the end of the quarter expands the company's international product offerings and positions Mentor for future growth and expansion in key international markets."

Total Net Sales
Total net sales were $95.6 million in the first quarter of fiscal year 2008, an increase of 20% over net sales of $79.4 million in the first quarter of fiscal year 2007.  The increase in net sales was primarily the result of strong sales of MemoryGel™ silicone breast implants in the U.S. augmentation market as it transitions from saline-filled breast implants to MemoryGel silicone breast implants.  Additionally, Mentor experienced strong sales growth in its international markets.  Net sales for the first quarter of fiscal year 2008 included approximately $0.7 million of positive foreign currency exchange effects.

Gross Profit
Gross profit for the first quarter of fiscal year 2008 was $74.3 million, or 77.8% of sales, compared to $57.4 million, or 72.2% of sales, in the first quarter of fiscal year 2007. Gross profit for the quarter benefited from higher sales of MemoryGel breast implants. Additionally, gross profit was favorably impacted by non-recurring adjustments related to product warranty accrual and inventory valuation, as well as positive manufacturing variances.

Selling, General and Administrative
Selling, general and administrative (SG&A) expenses in the first quarter of fiscal year 2008 were $36.0 million, or 37.7% of sales, compared to $29.7 million, or 37.4% of sales, in the first quarter of fiscal year 2007.  Included in SG&A expense in the first quarter 2007 were approximately $2.3 million of equity compensation expense recorded under the provisions of FAS 123(R) and $1.8 million of severance expense related to the company's business rationalization initiative.  Included in SG&A expense in the first quarter of fiscal year 2008 was approximately $3.2 million of equity compensation expense recorded under the provisions of FAS 123(R).

Research and Development
Research and development (R&D) expenses in the first quarter of fiscal year 2008 were $10.3 million, an increase of $2.4 million or 30.9% from the first quarter of fiscal year 2007.  For the quarter, the company's investment in R&D supported its botulinum toxin development program, its hyaluronic acid dermal filler development program with Genzyme Corporation, its Puragen™ Plus development program, its compliance with MemoryGel breast implants post-approval conditions, and the ongoing U.S. Food and Drug Administration (FDA) review of its Contour Profile® Gel breast implant premarket approval application (PMA).



•     Hyaluronic Acid-Based (HA) Dermal Fillers

During the quarter, the company made substantial progress in its HA development programs and, subsequent to the end of the first quarter, submitted PMAs to the FDA for Prevelle™ Plus and Puragen™ Plus.  Mentor anticipates approval for these products in the U.S. in late fiscal 2008 or early fiscal 2009.

 

•     Botulinum Toxin Type A

As previously announced, Mentor received protocol approval from the FDA for its pivotal Phase IIIa clinical trial and initiated treatment during the quarter in this pivotal study for the cosmetic correction of rhytides.  In addition, Mentor continues to make progress in patient enrollment in its Phase I study of its botulinum toxin type A for the treatment of pain associated with adult onset spasmodic torticollis/cervical dystonia.  Subsequent to the end of the quarter, the company initiated an expansion of its botulinum toxin type A production capacity in Madison, Wisconsin, to provide for the eventual vertical integration of certain manufacturing processes.

 

•     MemoryGel silicone gel breast implants Post-Approval Study (PAS)

As previously announced, Mentor received FDA approval to amend its PAS protocol changing to a voluntary patient enrollment design.  This change allows those patients who choose not to or cannot participate in Mentor's PAS the opportunity of selecting Mentor's MemoryGel breast implants for their surgery.  Mentor reports that it has substantially completed the process to convert the study to a voluntary patient design.  Mentor has continued with the mandatory requirement for physicians.  In addition, as of August 3, 2007, Mentor has enrolled approximately 13,000 patients towards the total target of 42,900 patients required by the PAS conditions. 

Net Interest
Interest income, net of interest expense, in the first quarter of fiscal year 2008, was $3.3 million.  In the first quarter of fiscal year 2007, interest income, net of interest expense, was $1.4 million.

Effective Tax Rate
Mentor's effective tax rate for continuing operations in the first quarter of fiscal year 2008 was 29.9% compared to 28.0% in the first quarter of fiscal year 2007.  The increase was primarily due to a shift of income among the various tax jurisdictions in which the company does business towards those jurisdictions with higher effective tax rates, additional tax expense related to income in international operations, and the accounting treatment of incentive stock options after the adoption of FAS 123(R).  Mentor adopted FASB Interpretation No. 48 "Accounting for Uncertainty in Income Taxes-an interpretation of FASB Statement No. 109" during the quarter and there was no material impact as a result of the adoption.

Earnings Per Share (EPS)
Excluding the results of discontinued operations of the company's Urology business, Mentor reported diluted EPS from continuing operations of $0.48 in the first quarter of fiscal year 2008, compared to the first quarter 2007 EPS of $0.33, an increase of 45 percent.

Acquisition of Perouse Plastie SAS
Subsequent to the end of the quarter, Mentor announced the completion of the acquisition of all the outstanding shares of Perouse Plastie SAS, a breast implant company based in Bornel, France for 42 million Euros, including approximately 3 million Euros of assumed debt, or $56.5 million.  This acquisition expands the company's international product offerings and strengthens the company's competitive market positioning in several key international markets.

Share Repurchase Program
During the quarter, the company repurchased 5.2 million shares of its common stock at an average price of $40.70 per share. Subsequent to the end of the quarter, an additional 3.5 million shares were repurchased at an average price of $41.40 per share. In the aggregate, 8.7 million shares were repurchased for a total investment of $357.8 million.  As of August 3, 2007, 1.1 million shares remain authorized for repurchase.

Balance Sheet
Mentor ended the first quarter of fiscal year 2008 with $291 million in cash and marketable securities, compared to $488 million at the end of fiscal year 2007.  Subsequent to the end of the quarter, Mentor repurchased approximately $147 million worth of its common shares for retirement and invested approximately $56.5 million in the acquisition of Perouse.  As a result, cash and marketable securities have decreased substantially from the amount reported as of June 30, 2007.

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Updated Guidance for Full Fiscal Year 2008
Mentor is providing the following updated guidance for full fiscal year 2008 including the results of Perouse Plastie:

•         Sales to be in the range of $370 million to $385 million;

•         Gross margin to be in the range of 73% to 75% of sales;

•         Selling, general and administrative expenses to be in the range of 39% to 41% of sales;

•         Research and development expenses to be in the range of 12% to 14% of sales;

•         Operating income to be approximately 20% of sales; 

•         Tax rate of approximately 30%; and

•         Diluted earnings per share from continuing operations of $1.40 to $1.45, assuming weighted average diluted shares
    outstanding of 42 million shares.

Conference Call
Mentor Corporation has scheduled a conference call today regarding this announcement.  Those interested in listening to a recording of the call may dial (800) 839-2417 at 6:00 p.m. ET today until Midnight ET, August 13, 2007.  You may also listen to the live web cast at 5:00 p.m. ET today or the archived call at www.mentorcorp.com, Investor Relations site under "Audio Archives".

Safe Harbor Statement
This release contains forward-looking statements including, but not limited to, statements relating to Mentor's current and anticipated product development activity and expenses, and  market acceptance of those products; the approval with conditions by the  FDA of the company's MemoryGel silicone gel breast implants PMA; the continuing review by the FDA of the company's Contour Profile® Gel silicone gel-filled breast implant PMA; the initiation and continuation of clinical studies with respect to the company's botulinum toxin Type A product; the development program for a portfolio of hyaluronic acid-based dermal fillers in conjunction with Genzyme; the acquisition of Perouse Plastie by Mentor; and statements about future sales, gross margin, selling, general, and administrative expenses, research and development expenses, operating income, tax rate, diluted earnings per share from continuing operations, shares outstanding and cash balances.

A number of factors could cause actual results to differ from the forward-looking statements  including, but not limited to, U.S. market acceptance and adoption of MemoryGel breast implants; patient enrollment in the FDA-mandated post-approval study for MemoryGel breast implants; the amount and timing of expenses to be incurred with respect to the MemoryGel breast implants post-approval study; the timing and conditions of FDA approval, if any, of the company's Contour Profile Gel breast implant PMA; the ability of the company to move forward in a timely manner with the PMAs for its hyaluronic acid-based dermal fillers; the timing and outcome of the PMAs submitted to the FDA; results of clinical development programs; the timing and outcome of various clinical trials undertaken by the company; the impact on revenue and expenses of delays in FDA approval and other governmental agencies for the approval and sale of any of the company's products; seasonal and economic factors which affect demand for aesthetic products and procedures; the ability of the company to identify and implement other product opportunities in the global aesthetics marketplace; competitive pressures and other factors such as the introduction or regulatory approval of new products by competitors and pricing of competing products and the resulting effects on sales and pricing of the company's  products; disruptions or other problems with sources of supply; significant product liability or other claims; difficulties with new product development, introduction and market acceptance; changes in the mix of the company's products sold; patent and intellectual property conflicts; product recalls; FDA or other governmental agency  rejection of new or existing products; changes in Medicare, Medicaid or third-party reimbursement policies; changes in government regulation; use of hazardous or environmentally sensitive materials; and other events. Risks and uncertainties relating to the Perouse acquisition include that the businesses of Mentor and Perouse will not be integrated successfully; anticipated synergies may not be fully realized or may take longer to be realized than expected; and possible disruption of the Perouse business, including with customers, employees, suppliers or third parties.

Important factors that may cause such a difference for Mentor include, but are not limited to, those factors described in the company's Annual Report on Form 10-K, recent Current Reports on Form 8‑K and other Securities and Exchange Commission filings.  These filings discuss the foregoing risks as well as other important risk factors that could contribute to such differences or otherwise affect the company's business, results of operations and financial condition.  The company undertakes no obligation to revise or update publicly any forward-looking statement for any reason.

Contact:
Mentor Corporation
Loren McFarland
Chief Financial Officer
(805) 879-6082

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MENTOR CORPORATION

CONSOLIDATED STATEMENTS OF INCOME

(Unaudited, in thousands, except per share data)

Three Months Ended
June 30,

%

2007

2006

Change

Net sales

 $

95,564 

 $

79,437 

20%

 

Cost of sales

21,224 

22,045 

(4)%

Gross profit

74,340 

57,392 

30%

 

Selling, general and administrative

36,045 

29,711 

21%

Research and development

10,314 

7,881 

31%

46,359 

37,592 

23%

 

Operating income from continuing operations

27,981 

19,800 

41%

 

Interest (expense)

(1,464)

(1,632)

(10)%

Interest income

4,774 

3,064 

56%

Other (expense) income

(294)

538 

(155)%

 

Income before income taxes

30,997 

21,770 

42%

 

Income taxes

9,253 

6,096 

52%

Net income from continuing operations

21,744 

15,674 

39%

 

Net income (loss) from discontinued operations
(net of income tax (benefit) expense of ($12) and $142,401)

(6)

225,728 

(100)%

Net income

 $

21,738 

 $

241,402 

(91)%

 

Basic earnings per share

 

Earnings per share from continuing operations

 $

0.54 

 $

0.37 

46%

Earnings per share from discontinued operations

5.32 

(100)%

 $

0.54 

 $

5.69 

(91)%

 

Diluted earnings per share

 

Earnings per share from continuing operations

 $

0.48 

 $

0.33 

45%

Earnings per share from discontinued operations

4.58 

(100)%

 

 $

0.48 

 $

4.91 

(90)%

 

Dividends per share

 $

0.20 

 $

0.18 

11%

 

Weighted average shares outstanding

 

Basic

40,465 

42,443 

(5)%

Diluted

46,950 

49,316 

(5)%

 

           

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MENTOR CORPORATION  
SALES BY PRINCIPAL PRODUCT LINE
(unaudited, in thousands)

Three Months Ended
June  30,

%

2007

2006

Change

Breast aesthetics

 $

84,493 

 $

69,422 

22%

Body aesthetics

4,028 

5,137 

(22)%

Other aesthetics, including facial

7,043 

4,878 

44%

Net sales from continuing operations  $

95,564 

 $

79,437 

20%

           

 

 
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MENTOR CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited, in thousands)

 

 

 

 

 

 

Assets

June 30, 2007

March 31, 2007

Current assets:

 
    Cash and marketable securities  $

291,161 

 $

487,740 

    Accounts receivable, net

71,724 

65,419 

    Inventories

37,076 

38,073 

    Deferred income taxes

24,266 

25,892 

    Prepaid income taxes and other expenses

18,515 

20,256 

Total current assets  $

442,742 

637,380 

 Property, plant and equipment, net

36,973 

34,683 

 Intangible assets, net

15,087 

15,963 

 Goodwill, net

12,753 

12,644 

 Other assets

10,908 

9,098 

Total assets

 $

518,463 

 $

709,768 

Liabilities and shareholders' equity

  Current liabilities

 $

109,294 

 $

112,731 

 Long-term liabilities

14,295 

12,169 

 Convertible subordinated notes

150,000 

150,000 

 Shareholders' equity

244,874 

434,868 

Total liabilities and shareholders' equity

 $

518,463 

 $

709,768 

  

         

6


MENTOR CORPORATION

CALCULATION OF DILUTED EARNINGS PER SHARE - RESTATED FOR CONTINUING OPERATIONS*

(unaudited, in thousands, except per share data)
 

Fiscal Year 2007 ending March 31, 2007

Quarter ending June 30, 2007

Q1

Q2

Q3

Q4

FY

Q1

Net income as reported from continuing
  operations

 $

15,674 

 $

10,823 

 $

14,750 

 $

16,377 

 $

57,624 

 $

21,744 

Add back after tax interest expense on
  convertible notes

802 

802 

802 

802 

3,208 

802 

Numerator for diluted EPS calculation for
  continuing operations

 $

16,476 

 $

11,625 

 $

15,552 

 $

17,179 

 $

60,832 

 $

22,546 

 

Numerator for diluted EPS calculation for
  discontinued operations

 $

225,728 

 $

(1,102)

 $

(1,122)

 $

9,486 

 $

232,990 

 $

(6)

 

Weighted average shares outstanding

42,443 

41,360 

41,916 

42,091 

41,960 

40,465 

Shares issuable through exercise of
  stock options

1,100 

1,115 

869 

803 

1,000 

678 

Shares issuable through conversion of
  convertible notes

5,147 

5,150 

5,153 

5,158 

5,152 

5,165 

Additional dilution for unvested restricted
  shares outstanding

299 

152 

185 

272 

151 

285 

Shares issuable through exercise of warrants
  (treasury stock method)

327 

769 

1,021 

1,072 

829 

357 

Denominator for diluted EPS from
  continuing operations

49,316 

48,546 

49,144 

49,396 

49,092 

46,950 

Denominator for diluted EPS from
  discontinued operations

49,316 

41,360 

41,916 

49,396 

49,092 

40,465 

Diluted earnings per share from
  continuing operations

 $

0.33 

 $

0.24 

 $

0.32 

 $

0.35 

 $

1.24 

 $

0.48 

 

Diluted earnings (loss) per share from
  discontinued operations

 $

4.58 

 $

(0.03)

 $

(0.03)

 $

0.19 

 $

4.75 

 $

0.00 

 

* Note: We classified our surgical urology and clinical and consumer healthcare segments as discontinued operations
  at March 31, 2006.  Accordingly we have restated our EPS calculation to reflect the results of these segments as
  discontinued operations.

 

 

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