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| AMMD > SEC Filings for AMMD > Form 10-K on 3-Mar-2009 | All Recent SEC Filings |
3-Mar-2009
Annual Report
products for men's incontinence and erectile restoration, to include products
and therapies targeted at benign prostatic hyperplasia (BPH) in men, as well as
urinary incontinence, pelvic organ prolapse and menorrhagia in women. We
estimate there are as many as 1.8 billion incidences of these conditions in the
global markets we serve, with many people suffering from multiple conditions.
Treatment options for these conditions vary considerably depending on the
severity of the condition. Approximately 450 million of these men and women have
conditions sufficiently severe so as to profoundly diminish their quality of
life and significantly impact their relationships. Our addressable market is
contained within this group of patients. Our product development and acquisition
strategies have focused on expanding our product offering for surgical
solutions, including less-invasive solutions for surgeons and their patients.
Our primary physician customers include urologists, gynecologists,
urogynecologists and colorectal surgeons.
We completed our 36th year of operations in 2008, with a continued focus on
technological innovation, market expansion and financial strength.
Our net sales grew from $463.9 million in 2007 to $501.6 million in 2008. In
2008, men's health contributed $219.2 million, or 44 percent of total net sales,
BPH therapy contributed $116.3 million, or 23 percent of total net sales, and
women's health contributed $166.1 million, or 33 percent of total net sales.
Our products for treating incontinence in both the men's and women's health
businesses drove revenue growth in 2008, particularly through the success of the
AdVance® male sling and the MiniArc® Single Incision Sling for treating female
stress urinary incontinence. Our erectile restoration product revenues grew
through notable expansion in a number of international markets. We provide a
full line of medical laser systems to deliver minimally invasive procedures for
the treatment of obstructive BPH and urinary stones. BPH therapy revenues
declined in 2008, as a result of a slower than anticipated market penetration
rate, but we have made considerable improvements to product performance in 2008
and are now selling throughout our global markets GreenLight HPS® (High
Performance System), and we continue to market our TherMatrx® solution for
in-office treatment of BPH. Revenue from our prolapse repair products, notably
Apogee® and Perigee®, also grew more significantly through expansion in
international markets and exited 2008 strong in all regions with the recent
launch of our new Elevate® posterior transvaginal prolapse repair system in the
back half of 2008. Our Her Option® product for the treatment of menorrhagia, or
excessive uterine bleeding, experienced a decline in revenues during the year,
with lower than expected adoption rates for office-based procedures.
In 2008, we implemented a number of company-wide initiatives to reduce working
capital, manage expenses and drive operating leverage throughout our business.
As a result, we generated income from operations of approximately $69 million in
2008, compared to $29.5 million in 2007, and cash from operations of
approximately $116 million in 2008, which more than doubled the 2007 amount of
$48 million. We also retired approximately $120 million of debt in 2008 compared
to approximately $50 million in 2007.
In January of 2007, we sold the Laserscope aesthetics business. All of the
information in this report, unless specifically stated otherwise, excludes the
Laserscope aesthetics business, which we reported as discontinued operations
during the six month period, July 2006 to January 2007, during which we held
this business.
Results of Operations
Sales trends
The following table compares net sales of our product lines and geographies
between 2008 and 2007, and between 2007 and 2006.
(in thousands) 2008 2007 $ Increase % Increase 2007 2006 $ Increase % Increase Net Sales Product Line Men's health $ 219,211 $ 188,519 $ 30,692 16.3 % $ 188,519 $ 160,436 $ 28,083 17.5 % BPH therapy 116,346 125,497 (9,151 ) -7.3 % 125,497 70,436 55,061 78.2 % Women's health 166,084 149,912 16,172 10.8 % 149,912 127,446 22,466 17.6 % Total $ 501,641 $ 463,928 $ 37,713 8.1 % $ 463,928 $ 358,318 $ 105,610 29.5 % Geography United States $ 355,678 $ 334,258 $ 21,420 6.4 % $ 334,258 $ 272,679 $ 61,579 22.6 % International 145,963 129,670 16,293 12.6 % 129,670 85,639 44,031 51.4 % Total $ 501,641 $ 463,928 $ 37,713 8.1 % $ 463,928 $ 358,318 $ 105,610 29.5 % Percent of net sales Product Line Men's health 43.7 % 40.6 % 40.6 % 44.8 % BPH therapy 23.2 % 27.1 % 27.1 % 19.7 % Women's health 33.1 % 32.3 % 32.3 % 35.5 % Total 100.0 % 100.0 % 100.0 % 100.0 % Geography United States 70.9 % 72.0 % 72.0 % 76.1 % International 29.1 % 28.0 % 28.0 % 23.9 % Total 100.0 % 100.0 % 100.0 % 100.0 % |
Net Sales. In 2008, net sales increased by 8.1 percent or $37.7 million over
2007. Growth in our business continues to be driven by the success of recent
product launches, particularly the AdVance® male sling for treating mild male
incontinence, the MiniArc®Single-Incision Sling, and the InhibiZone®-coated AMS
800® Artificial Urinary Sphincter, along with continuing launches of products
outside the United States, specifically the AMS 700® MS™ for erectile
restoration. We believe the current worldwide economic crisis has resulted and
may continue to result in some reduction in the procedures using our products.
Although a majority of our products are subject to reimbursement from third
party government and non-government entities, some procedures that use our
products can be deferred by patients. In light of the current economic
conditions, patients may not have employer-provided healthcare, be as willing to
take time off from work or spend their money on deductibles and co-payments
often required in connection with the procedures that use our products. While we
believe current economic conditions may have contributed to a softening in our
recent revenue growth rates, the specific impact is difficult to measure.
Furthermore, we cannot predict how these economic conditions will impact our
future sales.
In 2007, net sales grew by 29.5 percent or $105.6 million from 2006. The
increase was driven by a full year of sales of the GreenLight HPS® system, which
we acquired in July 2006, and the continued growth of the existing product lines
in both the male and female product portfolios. The existing product lines were
enhanced in 2007 by new product launches, particularly the MiniArc®
Single-Incision Sling and the InhibiZone®-coated AMS 800®Artificial Urinary
Sphincter along with continuing launches outside the United States, specifically
the AdVance® male sling and the AMS 700® MS™ for erectile restoration.
Men's health products. Net sales from men's health products grew 16.3 percent in
2008, following an increase of 17.5 percent in 2007.
The largest portion of the increase in 2008 is in the male continence product
line, driven by the continued success of the AdVance® male sling and the AMS
800® with InhibiZone®. Growth in sales of our erectile restoration products are
consistent with market growth rates.
In 2007, erectile restoration product sales experienced double digit growth,
driven by the continued worldwide rollout of the AMS 700® MS™, which features a
one-touch button design for easier deflation and was originally launched in the
United States in the fourth quarter of 2006. Male continence sales increased in
2007 as a result of strong growth in both the AMS 800® Artificial Urinary
Sphincter and the newly launched AdVance® male sling, which treats mild to
moderate incontinence.
BPH therapy products. Net sales from BPH therapy products declined 7.3 percent
in 2008, following an increase of 78.2 percent in 2007.
The decline in 2008 was driven by lower sales of our laser therapy products,
where we did not achieve the utilization rates anticipated as we have seen a
slowing in the surgical markets due to the increased use of drugs to treat BPH
as well as increased competition. We also experienced a decline in sales of our
TherMatrx® product, which is used for treatment of non-obstructive BPH, due to a
shift away from microwave therapies for in-office procedures.
Growth in BPH therapy net sales in 2007 over the same period in 2006 was driven
by laser therapy sales growth due to the first full year of revenue following
the Laserscope acquisition in July 2006. Partially offsetting this increase was
a decline in sales of our TherMatrx®product.
Women's health products. Net sales from women's health products grew
10.8 percent in 2008, following an increase of 17.6 percent in 2007. The decline
in net sales growth in 2008 compared to the prior year is primarily volume
driven.
The female continence product line, driven by the new MiniArc® sling,
contributed strong growth in dollars and units over 2007. The MiniArc®
Single-Incision Sling is our latest generation of slings, offering a less
invasive treatment for female incontinence. The MiniArc® requires just one
incision to surgically place a small strip of mesh material to support the
urethra. In the latter part of 2008, we launched our new Elevate®posterior
transvaginal prolapse repair system, which had a minimal impact on our results
for 2008. Our Her Option® products for the treatment of menorrhagia, or
excessive uterine bleeding, experienced a decline in revenues and units compared
to the prior year. Revenue growth in this area has been impacted as the industry
continues to experience lower than expected adoption rates for office-based
procedures.
In 2007, we saw balanced net sales growth in dollars from all three therapies.
Growth in sales and units of our female continence products was driven mainly by
continued growth of our Monarc® self-fixating slings and the 2007 launch of the
MiniArc® product. Our prolapse repair solutions, Apogee® and Perigee®, saw
worldwide growth in 2007, primarily driven by our continued commitment to and
emphasis on physician training. The Her Option® product grew significantly in
2007 as commercial payers continued to implement reimbursement for this therapy.
International sales and foreign exchange effects. Our consolidated net sales
grew $37.7 million, or 8.1 percent in 2008 from 2007. Of this growth,
$4.9 million, or 1.0 percentage point, was due to favorable currency exchange
rates in the markets in which we conduct business in a foreign currency. Because
a portion of the expenses associated with international sales are foreign
currency denominated costs, changes in these currency rates do not affect net
income and cash flows from operations by the same dollar amount as they affect
sales revenues.
In 2007, $7.6 million, or 2.1 percentage points, of the net sales growth from
2006 was due to favorable currency exchange rates.
Customer location 2008 2007 $ Increase % Increase 2007 2006 $ Increase % Increase Within U.S. $ 355,678 $ 334,258 $ 21,420 6.4 % $ 334,258 $ 272,679 $ 61,579 22.6 % International Before currency impact 141,109 129,670 11,439 8.8 % 122,083 85,639 36,444 42.6 % Subtotal 496,787 463,928 32,859 7.1 % 456,341 358,318 98,023 27.4 % Currency impact 4,854 - 4,854 - 7,587 - 7,587 - Total $ 501,641 $ 463,928 $ 37,713 8.1 % $ 463,928 $ 358,318 $ 105,610 29.5 % |
Operating Expenses
The following table compares the dollar and percentage change in the Statement
of Operations between 2008 and 2007, and between 2007 and 2006.
$ Increase % $ Increase %
(in thousands) 2008 2007 (Decrease) Change 2007 2006 (Decrease) Change
Net sales $ 501,641 $ 463,928 $ 37,713 8.1 % $ 463,928 $ 358,318 $ 105,610 29.5 %
Cost of sales 111,097 105,592 5,505 5.2 % 105,592 68,872 36,720 53.3 %
Gross profit 390,544 358,336 32,208 9.0 % 358,336 289,446 68,890 23.8 %
Operating expenses
Marketing and selling 175,670 169,495 6,175 3.6 % 169,495 123,204 46,291 37.6 %
Research and development 46,247 43,315 2,932 6.8 % 43,315 33,877 9,438 27.9 %
In-process research &
development 7,500 7,500 - 0.0 % 7,500 94,035 (86,535 ) -92.0 %
General and administrative 39,281 43,070 (3,789 ) -8.8 % 43,070 34,417 8,653 25.1 %
Integration costs - 1,103 (1,103 ) n/a 1,103 1,712 (609 ) -35.6 %
Litigation settlement - 14,303 (14,303 ) n/a 14,303 - 14,303 n/a
Amortization of intangibles 34,465 18,264 16,201 88.7 % 18,264 12,393 5,871 47.4 %
Total operating expenses 303,163 297,050 6,113 2.1 % 297,050 299,638 (2,588 ) -0.9 %
Operating income (expense) 87,381 61,286 26,095 42.6 % 61,286 (10,192 ) 71,478 n/a
Royalty income 4,474 5,028 (554 ) -11.0 % 5,028 1,701 3,327 195.6 %
Interest income 747 1,153 (406 ) -35.2 % 1,153 2,754 (1,601 ) -58.1 %
Interest expense (27,398 ) (37,760 ) (10,362 ) -27.4 % (37,760 ) (18,395 ) 19,365 105.3 %
Amortization of financing costs (4,099 ) (3,273 ) 826 25.2 % (3,273 ) (8,302 ) (5,029 ) -60.6 %
Gain on extinguishment of debt 10,055 - 10,055 n/a - - - n/a
Other income (expense) (2,195 ) 3,071 (5,266 ) n/a 3,071 283 2,788 985.2 %
Income (loss) from continuing
operations before income taxes 68,965 29,505 39,460 133.7 % 29,505 (32,151 ) 61,656 n/a
Provision for income taxes 26,413 15,914 10,499 66.0 % 15,914 11,731 4,183 35.7 %
Net income (loss) from
continuing operations 42,552 13,591 28,961 213.1 % 13,591 (43,882 ) 57,473 n/a
Loss from discontinued
operations, net of tax benefit
of $0.4 million and
$2.7 million for 2007 and 2006,
respectively - (691 ) 691 n/a (691 ) (5,435 ) (4,744 ) -87.3 %
Net income (loss) $ 42,552 $ 12,900 $ 29,652 229.9 % $ 12,900 $ (49,317 ) $ 62,217 n/a
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The following table shows the Statement of Operations as a percentage of net sales for 2008, 2007 and 2006.
2008 2007 2006
Net sales 100.0 % 100.0 % 100.0 %
Cost of sales 22.1 % 22.8 % 19.2 %
Gross profit 77.9 % 77.2 % 80.8 %
Operating expenses
Marketing and selling 35.0 % 36.5 % 34.4 %
Research and development 9.2 % 9.3 % 9.5 %
In-process research and development 1.5 % 1.6 % 26.2 %
General and administrative 7.8 % 9.3 % 9.6 %
Integration costs 0.0 % 0.2 % 0.5 %
Litigation settlement 0.0 % 3.1 % 0.0 %
Amortization of intangibles 6.9 % 3.9 % 3.5 %
Total operating expenses 60.4 % 64.0 % 83.6 %
Operating income (expense) 17.4 % 13.2 % -2.8 %
Royalty income 0.9 % 1.1 % 0.5 %
Interest income 0.1 % 0.2 % 0.8 %
Interest expense -5.5 % -8.1 % -5.1 %
Amortization of financing costs -0.8 % -0.7 % -2.3 %
Gain on extinguishment of debt 2.0 % 0.0 % 0.0 %
Other income (expense) -0.4 % 0.7 % 0.1 %
Income (loss) from continuing operations before
income taxes 13.7 % 6.4 % -9.0 %
Provision for income taxes 5.3 % 3.4 % 3.3 %
Net income (loss) from continuing operations 8.5 % 2.9 % -12.2 %
Net income (loss) 8.5 % 2.8 % -13.8 %
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Cost of sales. Gross margin improved 0.7 percentage points from 2007 to 2008.
Margins improved in 2008 as a result of changes in the mix of products sold,
improved inventory planning, lower warranty and service costs on our laser
therapy products and higher average selling prices. These improvements were
partially offset by a decline in margins on our laser therapy products from
about 54 percent in 2007 to 50 percent in 2008, primarily as a result of lower
production volume with the conclusion of the aesthetics product supply
agreement. Historically, margins have generally benefited from stable overhead
costs, which account for more than a quarter of our cost of sales. Future
margins will continue to depend upon product mix, production levels, labor
costs, raw material costs and our ability to manage overhead costs over time. We
expect margins for our laser therapy products to improve over time, through cost
reductions, favorable product mix and optimization of console and fiber
reliability.
Margins decreased 3.6 percentage points from 2006 to 2007 primarily driven by
the continued change in the mix of products sold, as equipment consoles for
laser therapy and Her Option®became a larger share of total revenue. We also
experienced increased warranty costs, which were 1.3 percent of sales in 2007,
compared to 0.2 percent in 2006, as a result of the continued enhancements made
to improve the reliability of the GreenLight HPS® console and fibers. As service
becomes a larger part of our business, we also saw a 0.5 percent increase in the
cost of service in 2007 compared to the prior year. These increased costs were
partially offset by favorable exchange impacts on gross margin for international
operations, the impact of increased volume and our ability to control overhead
spending.
Marketing and selling. Marketing and selling expenses as a percentage of sales
decreased by 1.5 percentage points in 2008. The decrease in the current period
relates to leveraging of investments made in 2007 primarily for the transition
from independent distributors to our direct sales force for international laser
therapy sales. As these investments were better leveraged in 2008, the result is
lower expense as a percentage of revenue. We will continue to invest in
marketing and selling in support of increasing sales levels, but we expect
marketing and selling expense will continue to decrease as a percentage of sales
over time.
Marketing and selling expenses increased by 2.1 percentage points in 2007 due to
the full year effect of the laser therapy sales force and marketing personnel of
Laserscope which was acquired in July of 2006, continued growth of the Her
Option® product line, the exchange rate impact for foreign operations and the
launches of several new products.
Research and development. Research and development includes costs to develop and
improve current and possible future products plus the costs for regulatory and
clinical activities for these products. Research and development expenses as a
percentage of revenue decreased to 9.2 percent in 2008 compared to 9.3 percent
in 2007. These ratios are in line with our long-term goal for spending in
research and development of approximately ten percent of sales.
The $9.4 million increase in research and development expense from 2006 to 2007
is related to a full year of costs associated with the Laserscope acquisition,
continuing development of GreenLight® fiber applications, increased personnel
and project work in the areas of applied research, product development, clinical
studies, regulatory filings and intellectual property support including those
related to our acquisitions of BioControl Medical, Ltd. (BioControl), Solarant
Medical, Inc. (Solarant), and Ovion Inc. (Ovion).
In-process research and development. The 2008 in-process research and
development (IPR&D) expense represents a $7.5 million milestone payment related
to our acquisition of BioControl for the in-process development of an
implantable electrical stimulation device to treat urge incontinence and
interstitial cystitis (IC). There was a similar milestone payment of
$7.5 million in 2007, also related to BioControl. The following paragraphs
describe the status of previously acquired IPR&D projects that remain in
progress at January 3, 2009.
During 2006, we recognized IPR&D charges of $94.0 million, of which
$25.6 million related to the acquisition of BioControl. As noted above, we
recognized additional IPR&D charges for BioControl of $7.5 million during 2007
and $7.5 million during 2008. Since the technology purchased had not yet reached
technological feasibility and lacked an alternative future use, the full
purchase price of $40.6 million was charged to in-process research and
development. The development efforts were less than 50 percent complete at the
time of the acquisition. During 2008, based on findings from earlier feasibility
studies, we incorporated the results of these studies into product enhancements.
We anticipate we will begin a new feasibility study for urge incontinence in
women late in 2009 or early in 2010.
Also during 2006, we recognized in-process research and development charges of
$62.1 million related to our acquisition of Laserscope, primarily associated
with in-process fiber development which had not yet reached technological
feasibility and lacked an alternative future use. This included the development
of fibers to treat bladder tumors, strictures and renal cancer, as well as other
laser indications. Development for these therapies was estimated to be less than
50 percent complete at the time of acquisition. In 2008, we launched the
extended application fiber for strictures and bladder tumors. We expect to
develop further enhancements for BPH therapy treatments in addition to
developing new laser therapy treatments. We are still in the development stages
for the remaining therapies and expect products to be developed from this
in-process development to reach marketability over the next several years.
We recognized additional IPR&D charges in 2006 of $4.3 million related to our
July 2005 acquisition of Ovion for the in-process development of a minimally
invasive permanent birth control device for women which had not yet reached
technological feasibility and lacked an alternative future use. The development
efforts were less than 20 percent complete at the time of the acquisition. As of
. . .
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