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American Medical Systems (AMMD) Starts 2010 with Strong First Quarter Performance

May 4, 2010 (Business Wire) — American Medical Systems Holdings, Inc. (NASDAQ: AMMD) reported revenue of $134.9 million for the first quarter of 2010, a 9.1 percent increase over sales of $123.6 million in the comparable quarter of 2009. The weakening of the U.S. dollar compared to the first quarter of 2009 positively affected revenue comparisons for the quarter by $2.6 million. Adjusting for this impact of foreign currency, results in first quarter revenue growth of 7.1 percent over the same period last year. The first quarter revenue of $134.9 million exceeds the Company’s guidance of $127 to $131 million. On a GAAP basis, the Company reported first quarter 2010 net income of $20.7 million, or $0.27 per share, compared to net income in the same period last year of $17.1 million, or $0.23 per share. Included in the first quarter 2010 net income was a $7.7 million pre-tax gain on the sale of the Her Option ® global endometrial ablation product line. Included in the first quarter 2009 net income was a $4.6 million pre-tax gain on the early extinguishment of approximately $27 million of convertible senior subordinated notes.

The Company reported strong non-GAAP adjusted earnings per share performance in the first quarter of 2010 of $0.29 per share compared to $0.25 per share in the comparable period last year. This exceeds the Company’s non-GAAP adjusted earnings per share guidance of $0.23 to $0.26 for the first quarter. Non-GAAP adjusted earnings per share excludes the impact of the amortization of intangible assets and amortization of financing costs, both significant non-cash items affecting comparability to other companies. The non-GAAP adjusted net income for the first quarter of 2010 also excludes the gain on the sale of the Her Option ® product line during the quarter. The first quarter of 2009 non-GAAP adjusted net income excludes the gain on the early extinguishment of convertible notes.

Men’s Health sales of $64.5 million in the first quarter, represented an increase of 8.4 percent on a reported basis compared to the same quarter last year, and grew 6.2 percent on a constant currency basis. Record performance in the erectile restoration product line was the driver for this strong performance, offset by flat revenue on a constant currency basis in male continence in the first quarter. The BPH therapy business increased 2.1 percent on a reported basis, with revenue consistent with last year on a constant currency basis, at $25.9 million during the quarter, with growth in the U.S. and Asia Pacific/Latin America geographies muted by declines in Europe. The Women’s Health business, excluding the Her Option® product line, which was sold during the quarter, increased 17.8 percent on a reported basis and 15.8 percent on a constant currency basis to $42.7 million in the first quarter. Pelvic Floor Repair had its strongest growth quarter yet, driven by the launch of Elevate® anterior in mid-2009. This strong growth was partially offset by relatively flat female continence product sales in the quarter. Revenue from uterine health of $1.8 million includes approximately $1.2 million in revenue prior to the sale of the Her Option ® product line in February 2010, in addition to $0.6 million in revenue from the product supply agreement with CooperSurgical, Inc., as part of the divestiture agreement.

“I am pleased to begin 2010 with a very strong first quarter, particularly driven by a continuing trend of robust performance in our erectile restoration and pelvic floor repair product lines,” noted Tony Bihl, Chief Executive Officer. “Despite slower than anticipated growth in our continence product lines, we exceeded our overall revenue expectations, driven by 10.7% growth in U.S. sales, reflecting the strength of our product offering and recent investments in the U.S. sales and marketing organization.” Mr. Bihl continued, “Solid operational performance, along with the successful divestiture of the Her Option ® product line allowed us to reduce debt nearly $46 million in the quarter, bringing our outstanding debt to under $400 million at the end of the first quarter.”

Outlook

The Company narrowed the range of its full year 2010 revenue guidance to $544 to $560 million from previous guidance in the range of $540 to $560 million. Second quarter revenue guidance is in the range of $135 to $139 million. This guidance assumes foreign currency exchange rates remain constant with current rates.

Consistent with 2009, the Company has two significant non-cash charges in GAAP earnings that create inconsistencies in comparisons to many other companies; amortization of financing costs and amortization of intangible assets. Accordingly the Company guides to non-GAAP adjusted earnings per share, which the Company defines as GAAP earnings per share excluding the impact of amortization of intangible assets and amortization of financing costs.

Reflecting the strong earnings performance experienced in the first quarter, the Company increased its full year 2010 non-GAAP adjusted earnings per share guidance to $1.19 to $1.27 from its earlier guidance of $1.16 to $1.24. Second quarter non-GAAP adjusted earnings per share guidance is in the range of $0.29 to $0.31. Both the full year and second quarter guidance exclude the impact of amortization of intangible assets which is approximately $0.02 and $0.10 for the second quarter and full year 2010, respectively, and amortization of financing costs which is approximately $0.03 and $0.11 for the second quarter and full year 2010, respectively. Guidance for both periods excludes the impact of any unusual non-recurring items that could occur, such as gain or loss on early debt extinguishments, sale of non-strategic assets or IPRD charges on milestone payments related to prior acquisitions.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), management provides non-GAAP adjusted net income, non-GAAP adjusted earnings per share and constant currency revenue growth rates because management believes that in order to properly understand the Company’s short-term and long-term financial trends and for purposes of comparability to other companies, investors may wish to consider the impact of certain adjustments (such as gain on extinguishment of debt, gain on sale of non-strategic assets, IPRD charges, amortization of intangible assets, amortization of financing costs and related income tax adjustments and the impact of foreign currency translation on reported revenue). These adjustments result from facts and circumstances (such as acquisition and business development activities and other non-recurring items) that vary in frequency and impact on the Company’s results of operations, represent significant items, which when excluded provide a useful measure to determine the health of the business and earnings by the business before significant non-cash charges or in the case of foreign currency translation, are highly variable and difficult to predict. Management uses non-GAAP adjusted net income, non-GAAP adjusted earnings per share and constant currency revenue growth rates to forecast and evaluate the operational performance of the Company as well as to compare results of current periods to prior periods on a consistent basis.

A reconciliation of net income and revenue growth rate percentages, the GAAP measure most directly comparable to non-GAAP adjusted earnings per share and constant currency revenue growth rates, respectively, are provided on the attached schedules.

Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Investors should consider non-GAAP measures in addition to, and not as a substitute for, or superior to, financial performance measures prepared in accordance with GAAP.

Earnings Call Information

American Medical Systems will host a conference call on Tuesday, May 4, 2010 at 5:00 p.m. eastern time to discuss its first quarter results and guidance for the second quarter. Those without internet access may join the call from within the U.S. by dialing 888-263-1724; outside the U.S., dial 706-679-3821.

A live web cast of the call will be available through the Company’s corporate website at www.AmericanMedicalSystems.com and will be available for replay three hours after the completion of the call.

About American Medical Systems

American Medical Systems, headquartered in Minnetonka, Minnesota, is a diversified supplier of medical devices and procedures to cure incontinence, erectile dysfunction, benign prostate hyperplasia (BPH), pelvic floor repair and other pelvic disorders in men and women. These disorders can significantly diminish one’s quality of life and profoundly affect social relationships. In recent years, the number of people seeking treatment has increased markedly as a result of longer lives, higher-quality-of-life expectations and greater awareness of new treatment alternatives. American Medical Systems’ products reduce or eliminate the incapacitating effects of these diseases, often through minimally invasive therapies. The Company’s products were used to treat approximately 335,000 patients in 2009.

Forward-Looking Statements

This press release contains forward-looking statements relating to the market opportunities, future products, sales and financial results of American Medical Systems. These statements and other statements contained in this press release that are not purely historical fact are forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are based on management’s beliefs, certain assumptions and current expectations. These forward-looking statements are subject to risks and uncertainties such as successfully competing against competitors; physician acceptance, endorsement, and use of AMS products; potential product recalls or technological obsolescence; healthcare reform legislation in the U.S.; successfully managing debt leverage and related credit facility financial covenants; current worldwide economic conditions and the impact on operations of the disruption in global financial markets; factors impacting the stock market and share price and its impact on the dilution of convertible securities; ability of the Company’s manufacturing facilities to meet customer demand; reliance on single or sole-sourced suppliers; loss or impairment of a principal manufacturing facility; clinical and regulatory matters; timing and success of new product introductions; patient acceptance of the Company’s products and therapies; changes in and adoption of reimbursement rates; adequate protection of the Company’s intellectual property rights; product liability claims; currency and other economic risks inherent in selling our products internationally and other risks and uncertainties described in the Company’s Annual Report on Form 10-K for the year ended January 2, 2010, and its other SEC filings. Actual results may differ materially from anticipated results. The forward-looking statements contained in this press release are made as of the date hereof, and AMS undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

More information about the Company and its products can be found at its website www.AmericanMedicalSystems.com and in the Company’s Annual Report on Form 10-K for 2009 and its other SEC filings.

American Medical Systems Holdings, Inc.
Statements of Operations
(In thousands, except per share data)
Three Months Ended
April 3, 2010 April 4, 2009
(Unaudited) (Unaudited)
Net sales $ 134,926 $ 123,638
Cost of sales 21,027 23,342
Gross profit 113,899 100,296
Operating expenses
Marketing and selling 48,197 43,348
Research and development 13,509 12,811
General and administrative 12,690 10,779
Amortization of intangibles 3,047 3,265
Total operating expenses 77,443 70,203
Operating income 36,456 30,093
Other (expense) income
Royalty income 308 933
Interest expense (3,954 ) (5,410 )
Amortization of financing costs (3,693 ) (3,981 )
Gain on extinguishment of debt 4,562
Gain on sale of non-strategic assets 7,719
Other (expense) income (516 ) 655
Total other (expense) income (136 ) (3,241 )
Income before income taxes 36,320 26,852
Provision for income taxes 15,662 9,772
Net income $ 20,658 $ 17,080
Net income per share
Basic net income $ 0.28 $ 0.23
Diluted net income $ 0.27 $ 0.23
Weighted average common shares used in calculation
Basic 75,117 73,691
Diluted 76,270 74,018
American Medical Systems Holdings, Inc.
Condensed Balance Sheets
(In thousands)
April 3, 2010 January 2, 2010
(Unaudited)
Assets
Current assets
Cash and short-term investments $ 59,865 $ 50,538
Accounts receivable, net 93,390 102,590
Inventories, net 30,903 30,276
Other current assets 22,237 20,937
Total current assets 206,395 204,341
Property, plant and equipment, net 42,866 44,120
Goodwill and intangibles, net 781,579 792,467
Other long-term assets 5,858 6,223
Total assets $ 1,036,698 $ 1,047,151
Liabilities and stockholders’ equity
Current liabilities
Accounts payable $ 11,043 $ 9,114
Accrued liabilities and taxes 60,226 62,151
Total current liabilities 71,269 71,265
Debt and other long term liabilities 388,432 430,527
Total liabilities 459,701 501,792
Stockholders’ equity 576,997 545,359
Total liabilities and stockholders’ equity $ 1,036,698 $ 1,047,151
American Medical Systems Holdings, Inc.
Condensed Statements of Cash Flows
(Unaudited)
(In thousands)
Three Months Ended
April 3, 2010 April 4, 2009
Cash flows from operating activities
Net income $ 20,658 $ 17,080
Adjustments to reconcile net income to net cash provided
by operating activities:
Depreciation and amortization, including deferred financing costs 9,264 9,684
Gain on extinguishment of debt (4,562 )
Gain on sale of non-strategic assets (7,719 )
Stock-based compensation 1,829 2,216
Other adjustments, including changes in operating assets
and liabilities 2,576 3,790
Net cash provided by operating activities 26,608 28,208
Cash flows from investing activities
Purchase of property, plant and equipment (1,314 ) (1,108 )
Purchase of other intangibles (693 )
Purchase of short-term investments, net of redemptions (17,704 ) 3,376
Sale of non-strategic asset 20,186
Other cash flows from investing activities 783 680
Net cash provided by investing activities 1,258 2,948
Cash flows from financing activities
Payments on senior secured credit facility (45,719 ) (8,585 )
Repurchase of convertible senior subordinated notes (21,125 )
Other cash flows from financing activities 9,560 918
Net cash used in financing activities (36,159 ) (28,792 )
Effect of currency exchange rates on cash (165 ) 520
Net (decrease) increase in cash and cash equivalents (8,458 ) 2,884
Cash and cash equivalents at beginning of period 30,670 11,642
Cash and cash equivalents at end of period $ 22,212 $ 14,526
American Medical Systems Holdings, Inc.
Selected Sales Information and Constant Currency Growth Reconciliation
(Unaudited)
(In thousands)
Three Months Ended Constant Currency Growth Reconciliation (a)
Percent Growth
Percent Currency at Constant
April 3, 2010 April 4, 2009 Growth Impact Currency
Sales
Men’s health $ 64,480 $ 59,459 8.4 % $ 1,330 6.2 %
BPH therapy 25,911 25,389 2.1 % 513 0.0 %
Women’s health 42,748 36,300 17.8 % 708 15.8 %
Uterine health (b) 1,787 2,490 -28.2 % -28.2 %
Total $ 134,926 $ 123,638 9.1 % 2,551 7.1 %
Geography
United States $ 96,523 $ 87,180 10.7 % $ 10.7 %
United States-Uterine health (b) 1,787 2,490 -28.2 % -28.2 %
International 36,616 33,968 7.8 % 2,551 0.3 %
Total $ 134,926 $ 123,638 9.1 % 2,551 7.1 %
Percent of total sales
Men’s health 48 % 48 %
BPH therapy 19 % 21 %
Women’s health 32 % 29 %
Uterine health (b) 1 % 2 %
Total 100 % 100 %
Geography
United States 73 % 73 %
International 27 % 27 %
Total 100 % 100 %
(a) To calculate the currency impact on revenue growth rates, the Company compares each period’s sales, assuming no fluctuation in foreign currency exchange rates between periods. The generally accepted accounting principle (GAAP) measure most comparable to this non-GAAP measure is growth rate percentages based on GAAP revenue.
(b) The uterine health product line, Her Option ® was sold in February, 2010. Revenues in the first quarter of 2010 consist of end-customer revenue earned prior to the date of sale, in addition to revenue earned as part of the product supply agreement, which was part of the divestiture agreement with CooperSurgical, Inc.
American Medical Systems Holdings, Inc.
Reconciliation of Reported Net Income to Non-GAAP Adjusted Net Income
(Adjustments are presented on a pre-tax basis)
(Unaudited)
(In thousands, except per share data)
Three Months Ended
April 3, 2010 April 4, 2009
Net income, as reported $ 20,658 $ 17,080
Adjustments to net income:
Amortization of intangibles (a) 3,047 3,265
Amortization of financing costs (b) 3,693 3,981
Gain on extinguishment of debt (c) (4,562 )
Gain on sale of non-strategic assets (d) (7,719 )
Tax effect of adjustments to net income (e) 2,533 (977 )
Non-GAAP adjusted net income $ 22,212 $ 18,787
Net income per share
Basic $ 0.28 $ 0.23
Diluted $ 0.27 $ 0.23
Non-GAAP adjusted earnings per share
Basic $ 0.30 $ 0.25
Diluted $ 0.29 $ 0.25
Weighted average common shares used in calculation:
Basic 75,117 73,691
Diluted 76,270 74,018
(a) Consists of amortization of intangible assets, primarily developed and core technology.
(b) Consists of amortization of financing costs on our convertible senior subordinated notes and senior secured credit facility.
(c) Relates to the gain on retiring approximately $27 million of convertible senior subordinated notes.
(d) Relates to the gain on the sale of the Her Option® Global Endometrial Ablation product line.
(e) Includes the tax effect of each of the above items in each of the periods.
American Medical Systems Holdings, Inc.
Selected 2009 Sales Information
(Unaudited)
(In thousands)
Three Months Ended
Year Ended
April 4, 2009 July 4, 2009 October 3, 2009 January 2, 2010 January 2, 2010
Sales
Men’s health $ 59,459 $ 56,965 $ 54,666 $ 63,504 $ 234,594
BPH therapy 25,389 28,084 27,686 33,309 114,468
Women’s health 36,300 38,469 38,848 45,750 159,367
Uterine health (a) 2,490 2,870 2,031 3,450 10,841
Total $ 123,638 $ 126,388 $ 123,231 $ 146,013 $ 519,270
Geography
United States $ 89,670 $ 89,404 $ 92,262 $ 102,562 $ 373,898
International 33,968 36,984 30,969 43,451 145,372
Total $ 123,638 $ 126,388 $ 123,231 $ 146,013 $ 519,270
Percent of total sales
Men’s health 48 % 45 % 44 % 43 % 45 %
BPH therapy 21 % 22 % 22 % 23 % 22 %
Women’s health 29 % 30 % 32 % 31 % 31 %
Uterine health (a) 2 % 2 % 2 % 2 % 2 %
Total 100 % 100 % 100 % 100 % 100 %
Geography
United States 73 % 71 % 75 % 70 % 72 %
International 27 % 29 % 25 % 30 % 28 %
Total 100 % 100 % 100 % 100 % 100 %
(a) The uterine health product line, Her Option ® was sold in February, 2010. Net sales related to Her Option ® for each quarter in fiscal year 2009, and annual net sales for fiscal year 2009, are reflected in the table above.
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