American Medical Systems Announces Strong Third Quarter 2009 Performance

November 4, 2009 4:05 PM EST

    --  Non-GAAP adjusted EPS of $0.27 grows 50% over prior year; GAAP EPS of
        $0.38 exceeds prior year by $0.33
    --  Full year 2009 revenue and earnings guidance increased
    --  Record $49 million debt reduction in the third quarter

MINNEAPOLIS--(BUSINESS WIRE)-- American Medical Systems Holdings, Inc. (NASDAQ: AMMD) reported revenue of $123.2 million for the third quarter of 2009, a 4.9 percent increase from revenue of $117.5 million in the comparable quarter of 2008. The strengthening of the U.S. dollar had a negative impact on revenue of $2.1 million in the third quarter compared to the prior year. Excluding the impact of foreign currency fluctuations, third quarter revenue grew 6.7 percent over the same period last year. On a GAAP basis, the Company reported 2009 third quarter net income of $28.6 million, or $0.38 per share, compared to net income in the same period last year of $3.5 million, or $0.05 per share. Included in the third quarter 2009 net income was a $17.4 million pre-tax gain on the sale of the Ovion technology as well as a $5.6 million pre-tax gain on the exchange of the majority of the Company's 3.25% Convertible Senior Subordinated Notes due 2036, completed during the quarter. Third quarter 2008 net income was reduced for a $7.5 million pre-tax in-process research and development (IPRD) charge on a milestone payment related to a prior acquisition.

The Company also reported very strong non-GAAP adjusted EPS performance in the third quarter of 2009 of $0.27 per share compared to $0.18 per share in the comparable period last year. This exceeds the Company's non-GAAP adjusted EPS guidance of $0.17 to $0.21 per share for the third quarter. Non-GAAP adjusted EPS 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 third quarter of 2009 also excludes the gain on sale of the Ovion technology and the gain on exchange of the majority of its convertible notes during the quarter. Non-GAAP adjusted EPS for the third quarter of 2008 excludes the IPRD charge on a milestone payment related to a prior acquisition. A reconciliation of reported net income to non-GAAP adjusted net income is provided in the attached schedules.

Men's Health led the third quarter revenue growth, which at $54.7 million was up 6.6 percent on a reported basis compared to the same quarter last year and grew 8.7 percent on a constant currency basis. Erectile restoration revenue growth continued its strong performance, while third quarter male continence revenue growth improved over the muted growth we experienced in the second quarter. Our BPH therapy business was up 3.1 percent on a reported basis and grew 4.9 percent on a constant currency basis to $27.7 million during the quarter, driven by strong sales of laser fibers, particularly in our United States market. The Women's Health business increased 4.0 percent on a reported basis and 5.4 percent on a constant currency basis to $40.9 million in the third quarter. Highlighting the quarter was very strong performance from our pelvic floor repair products, benefiting from the recent launch of our new Elevate(R) anterior product. Third quarter revenue growth rates from our female continence products improved over second quarter growth rates and, as anticipated, sales from uterine health declined this quarter.

"We are very pleased with the strong financial performance in the third quarter of 2009, demonstrated by accelerated growth rates across all three business units. Particularly notable, we returned to a growth position in our BPH business, despite continued softness in capital sales," stated Tony Bihl, Chief Executive Officer. "In addition, we completed two very strategic transactions in the quarter: the sale of the Ovion technology and the $250 million exchange of our convertible notes. Operationally, we continued with our disciplined approach to spending and working capital management, which combined with the cash we received from the sale of the Ovion technology allowed us to make cash payments at a record quarterly amount of $49 million on our debt. We delivered revenue and earnings exceeding the high end of guidance and as a result, have increased our expectations for full year 2009 revenue and earnings performance."

Outlook

The Company estimates fourth quarter revenue in the range of $136 to $142 million, resulting in full year 2009 revenue guidance of $509 to $515 million; an increase from previous 2009 revenue guidance of $495 to $510 million. This guidance assumes foreign currency exchange rates remain constant with current rates.

In May 2008, the Financial Accounting Standards Board (FASB) issued new guidance related to accounting for convertible debt instruments, which the Company adopted in the first quarter 2009 (and applied retrospectively to prior periods). This new guidance changed the balance sheet classification of a component of the Company's convertible notes between equity and debt, and resulted in additional non-cash interest charges being reflected in the statement of operations. The Company estimates that the adoption of this new accounting guidance will reduce net income for fiscal year 2009 by approximately $0.11 per share.

Given the significant impact of the amortization of financing costs resulting from the implementation of the new FASB guidance in 2009, combined with the amortization of intangible assets, the Company has two significant non-cash charges in GAAP earnings that create inconsistencies in comparisons to many other companies. Accordingly the Company now 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. This guidance also excludes the impact of any unusual non-recurring items that could occur in 2009, such as the gain on early debt extinguishment, the gain on sale of non-strategic assets, or IPRD charges on milestone payments related to prior acquisitions.

Reflecting the strong earnings performance experienced in the first three quarters, the Company estimates fourth quarter 2009 non-GAAP adjusted earnings per share will be in the range of $0.29 to $0.33 and full year 2009 non-GAAP adjusted earnings per share in the range of $1.10 to $1.14. This is an increase from previous guidance for the full year 2009 in the range of $1.00 to $1.10. This guidance excludes the impact of amortization of intangible assets which is approximately $0.03 and $0.11 for the fourth quarter and full year 2009, respectively, and amortization of financing costs which is approximately $0.04 and $0.14 for the fourth quarter and full year 2009, 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 from continuing operations and revenue growth rate percentages, the GAAP measures 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 Wednesday, November 4, 2009 at 5:00 p.m. eastern time to discuss its 2009 third quarter results. 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 within 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 320,000 patients in 2008.

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; 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; potential obligations to make significant contingent payments under prior acquisitions; 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 3, 2009, 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 2008 and its other SEC filings.


American Medical Systems Holdings, Inc.

Statements of Operations

(Unaudited)

(In thousands, except per share data)

                Three Months Ended              Nine Months Ended

                October 3,   September 27,      October 3,   September 27,
                2009         2008               2009         2008

Net sales       $ 123,231    $ 117,468          $ 373,257    $ 367,627

Cost of sales     21,284       24,863             66,234       83,038

Gross profit      101,947      92,605             307,023      284,589

Operating
expenses

Marketing and     42,489       42,226             128,690      133,608
selling

Research and      12,434       11,260             38,411       33,926
development

In-process
research and      -            7,500              -            7,500
development

General and       10,459       9,728              32,898       30,435
administrative

Amortization      3,358        4,334              10,024       12,981
of intangibles

Total
operating         68,740       75,048             210,023      218,450
expenses

Operating         33,207       17,557             97,000       66,139
income

Other
(expense)
income

Royalty income    961          745                2,768        3,576

Interest          17           203                163          555
income

Interest          (4,674  )    (6,168  )          (15,050 )    (21,044 )
expense

Amortization
of financing      (4,395  )    (4,935  )          (12,350 )    (13,976 )
costs

Gain on
extinguishment    5,563        -                  10,125       -
of debt

Gain on sale
of                17,446       -                  17,446       -
non-strategic
asset

Other
(expense)         (341    )    (957    )          935          973
income

Total other
income            14,577       (11,112 )          4,037        (29,916 )
(expense)

Income before     47,784       6,445              101,037      36,223
income taxes

Provision for     19,163       2,940              38,471       14,813
income taxes

Net income      $ 28,621     $ 3,505       (a)  $ 62,566     $ 21,410      (a)

Net income per
share

Basic net       $ 0.39       $ 0.05        (a)  $ 0.85       $ 0.29        (a)
income

Diluted net       0.38         0.05        (a)    0.84         0.29        (a)
income

Weighted
average common
shares used in
calculation

Basic             74,278       73,095             73,939       72,796

Diluted           74,998       74,209             74,456       73,945




     Third quarter 2008 net income and basic and diluted net income per share
     were reduced by $2,229 and $0.03 per share, respectively, and year-to-date
     2008 net income and basic and diluted net income per share were reduced by
(a)  $6,529 and $0.09 per share, respectively, due to the impact of
     retroactively adjusting the historical financial statements, as required by
     U.S. GAAP, for the change in accounting related to the Company's 2036
     Convertible Notes.




American Medical Systems Holdings, Inc.

Condensed Balance Sheets

(In thousands)

                                            October 3, 2009  January 3, 2009

                                            (Unaudited)      (a)

Assets

Current assets

Cash and short-term investments             $ 49,511         $ 42,965

Accounts receivable, net                      88,198           93,078

Inventories, net                              33,629           38,500

Other current assets                          18,469           19,766

Total current assets                          189,807          194,309

Property, plant and equipment, net            44,777           48,280

Goodwill and intangibles, net                 795,040          799,761

Other long-term assets                        6,499            2,147

Total assets                                $ 1,036,123      $ 1,044,497

Liabilities and stockholders' equity

Current liabilities

Accounts payable                            $ 7,848          $ 7,830

Accrued liabilities and taxes                 60,149           55,480

Total current liabilities                     67,997           63,310

Debt and other long term liabilities          452,460          553,705

Total liabilities                             520,457          617,015

Stockholders' equity                          515,666          427,482

Total liabilities and stockholders' equity  $ 1,036,123      $ 1,044,497




(a)  Retroactively adjusted as of January 3, 2009, as required by U.S. GAAP, for
     the change in accounting related to the Company's Convertible Notes.




American Medical Systems Holdings, Inc.

Condensed Statements of Cash Flows

(Unaudited)

(In thousands)

                                         Nine Months Ended

                                         October 3, 2009  September 27, 2008

Cash flows from operating activities

Net income                               $ 62,566         $ 21,410           (a)

Adjustments to reconcile net income to
net cash provided

by operating activities:

Depreciation and amortization,             29,664           34,487           (a)
including deferred financing costs

In-process research and development        -                7,500

Gain on extinguishment of debt             (10,125  )       -

Gain on sale of non-strategic assets       (17,446  )       -

Stock based compensation                   6,649            7,135

Other adjustments, including changes in    25,877           8,095
operating assets and liabilities

Net cash provided by operating             97,185           78,627
activities

Cash flows from investing activities

Purchase of property, plant and            (3,688   )       (4,139  )
equipment

Disposal of business                       -                4,690

Sale of non-strategic assets, net          18,982           -

Purchase of investments in technology      -                (7,500  )

Purchase of other intangibles              (5,392   )       (1,262  )

Purchase of short term investments, net    11,895           (21,660 )
of redemptions

Other cash flows from investing            (171     )       560
activities

Net cash provided by (used in)             21,626           (29,311 )
investing activities

Cash flows from financing activities

Payments on senior secured credit          (78,173  )       (79,018 )
facility

Repurchase of convertible senior           (21,125  )       -
subordinated notes

Debt issuance costs                        (7,697   )       -

Other cash flows from financing            6,902            8,623
activities

Net cash used in financing activities      (100,093 )       (70,395 )

Effect of currency exchange rates on       (614     )       (152    )
cash

Net increase in cash and cash              18,104           (21,231 )
equivalents

Cash and cash equivalents at beginning     11,642           34,044
of period

Cash and cash equivalents at end of      $ 29,746         $ 12,813
period




     Year-to-date 2008 net income was reduced by $6,529 and amortization of
     financing costs was increased by $10,479, due to the impact of
(a)  retroactively adjusting the historical financial statements, as required by
     U.S. GAAP, for the change in accounting related to the Company's 2036
     Convertible Notes. This change in accounting has no impact on cash used for
     interest on the 2036 Convertible Notes.




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

                                                        Currency    at Constant

               October 3, 2009  September 27,  Percent  Impact      Currency
                                2008           Growth

Sales

Men's health   $ 54,666         $ 51,303       6.6  %   $ (1,090 )  8.7 %

BPH therapy      27,686           26,862       3.1  %     (486   )  4.9 %

Women's          40,879           39,303       4.0  %     (557   )  5.4 %
health

Total          $ 123,231        $ 117,468      4.9  %   $ (2,133 )  6.7 %

Geography

United States  $ 92,262         $ 84,489       9.2  %   $ -         9.2 %

International    30,969           32,979       -6.1 %     (2,133 )  0.4 %

Total          $ 123,231        $ 117,468      4.9  %   $ (2,133 )  6.7 %

Percent of
total sales

Men's health     44      %        44      %

BPH therapy      23      %        23      %

Women's          33      %        33      %
health

Total            100     %        100     %

Geography

United States    75      %        72      %

International    25      %        28      %

Total            100     %        100     %




     To calculate the currency impact on revenue growth rates, the Company
     compares each period's sales, assuming no fluctuation in foreign currency
(a)  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.




American Medical Systems Holdings, Inc.

Selected Sales Information and Constant Currency Growth Reconciliation

(Unaudited)

(In thousands)

               Nine Months Ended               Constant Currency Growth
                                               Reconciliation (a)

                                                                     Percent
                                                                     Growth

                                                        Currency     at Constant

               October 3, 2009  September 27,  Percent  Impact       Currency
                                2008           Growth

Sales

Men's health   $ 171,090        $ 160,548      6.6  %   $ (5,978  )  10.3 %

BPH therapy      81,159           86,157       -5.8 %     (2,817  )  -2.5 %

Women's          121,008          120,922      0.1  %     (3,276  )  2.8  %
health

Total          $ 373,257        $ 367,627      1.5  %   $ (12,071 )  4.8  %

Geography

United States  $ 271,336        $ 258,700      4.9  %   $ -          4.9  %

International    101,921          108,927      -6.4 %     (12,071 )  4.6  %

Total          $ 373,257        $ 367,627      1.5  %   $ (12,071 )  4.8  %

Percent of
total sales

Men's health     46      %        44      %

BPH therapy      22      %        23      %

Women's          32      %        33      %
health

Total            100     %        100     %

Geography

United States    73      %        70      %

International    27      %        30      %

Total            100     %        100     %




     To calculate the currency impact on revenue growth rates, the Company
     compares each period's sales, assuming no fluctuation in foreign currency
(a)  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.




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              Nine Months Ended

                October 3,   September 27,      October 3,   September 27,
                2009         2008               2009         2008

Net income, as  $ 28,621     $ 3,505       (a)  $ 62,566     $ 21,410      (a)
reported

Adjustments to
net income:

Amortization
of intangibles    3,358        4,334              10,024       12,981
(b)

Amortization
of financing      4,395        4,935              12,350       13,976
costs (c)

In-process
research and      -            7,500              -            7,500
development
charge (d)

Gain on
extinguishment    (5,563  )    -                  (10,125 )    -
of debt (e)

Gain on sale
of                (17,446 )    -                  (17,446 )    -
non-strategic
asset (f)

Tax effect of
adjustments to    6,615        (6,583 )           2,976        (13,444 )
net income (g)

Non-GAAP
adjusted net    $ 19,980     $ 13,691           $ 60,345     $ 42,423
income

Net income per
share

Basic           $ 0.39       $ 0.05             $ 0.85       $ 0.29

Diluted         $ 0.38       $ 0.05             $ 0.84       $ 0.29

Non-GAAP
adjusted
earnings per
share

Basic           $ 0.27       $ 0.19             $ 0.82       $ 0.58

Diluted         $ 0.27       $ 0.18             $ 0.81       $ 0.57

Weighted
average common
shares used in
calculation:

Basic             74,278       73,095             73,939       72,796

Diluted           74,998       74,209             74,456       73,945




     Third quarter 2008 net income was reduced by $2,229 and year-to-date 2008
(a)  net income was reduced by $6,529 to reflect the impact of retroactively
     adjusting the historical financial statements, as required by GAAP, for the
     change in accounting related to the Company's Convertible Notes.




(b)  Consists of amortization of intangible assets, primarily developed and core
     technology.




(c)  Consists of amortization of financing costs on our convertible senior
     subordinated notes and senior secured credit facility.




(d)  Relates to a milestone payment made in the third quarter of 2008 on the
     2006 acquisition of BioControl Medical, Ltd.




     Relates to the $5.6 million gain in the third quarter 2009 on exchanging
     $250.0 million of 2036 convertible senior subordinated notes for a like
(e)  amount of 2041 convertible senior subordinated notes and year-to-date 2009
     also includes the $4.6 million gain in the first quarter of 2009 on
     retiring approximately $27.3 million of 2036 convertible senior
     subordinated notes.




(f)  Relates to the gain on sale of female sterilization and Ovion technology
     assets.




(g)  Includes the tax effect of each of the above items in each of the periods.




    Source: American Medical Systems


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