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2 0 0 6 A n n u A l R e p o R t
t A B l e o f c o n t e n t s financial highlights - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
chairman’s Annual letter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2 – 3
history - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4 – 5
expansion - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6 – 7
Diversification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8 – 11
opportunity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12 – 15
executive committee - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16
Special Note Regarding Forward-Looking Statements
this annual report, including the chairman’s Annual letter and our form 10 -K included in this report, contains forward -looking statements (within the meaning of the federal securities
laws) that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this annual report regarding our strategy, future operations,
future financial position, future net sales, projected costs, projected expenses, prospects, and plans and objectives of management are forward -looking statements. the words
“anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would,” and similar expressions are intended to identify forward -looking statements, although not all
forward -looking statements contain these identifying words. We have based these forward -looking statements on our current expectations and projections about future events. Although
we believe that the expectations underlying any of our forward -looking statements are reasonable, these expectations may prove to be incorrect, and all of these statements are subject
to risks and uncertainties. should one or more of these risks and uncertainties materialize, or should underlying assumptions, projections, or expectations prove incorrect, actual results,
performance, or financial condition may vary materially and adversely from those anticipated, estimated, or expected. these risks and uncertainties include, but are not limited to, the
unpredictability of our quarterly net sales and results of operations; our inability to keep pace with a rapidly evolving marketplace and to develop or acquire and then successfully market
new and enhanced products; a highly competitive market for medical devices; the effect of a disaster at our manufacturing facility; the loss of any significant suppliers, especially
sole -source suppliers; our inability to adequately grow our operations and attain sufficient operating scale; our inability to obtain adequate profit margins; our inability to effectively protect
our intellectual property and not infringe on the intellectual property of others; possible product liability lawsuits and product recalls; inadequate levels of third -party reimbursement to
healthcare providers; our inability to initiate, complete, or achieve favorable results from clinical studies of our products; our inability to obtain and maintain u.s. and foreign regulatory
clearance for our products and our manufacturing operations; our inability to raise sufficient capital when necessary or at satisfactory valuations; loss of key personnel; and other factors
discussed elsewhere in this annual report.
We may not actually achieve the plans, intentions, or expectations disclosed in our forward -looking statements, and you should not place undue reliance on our forward -looking
statements. We have included important factors in the cautionary statements included in this annual report, particularly in the section entitled “Risk factors” in the form 10 -K included
in this report, that we believe could cause actual results or events to differ materially from the forward -looking statements that we make. our forward -looking statements do not reflect
the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may make. We do not assume any obligation to update any forward -looking
statements, whether as a result of new information, future events, or otherwise, except as required by law.
Non-GAAP Reconciliation:
(thousANds) uNAudited
2005
2006 % increase
Reported revenues
$30,727 $34,628
13%
expedial revenues
365
Private label revenues
Adjusted revenues
699 —
$29,663 $34,602
26 —
—
17%
F I N A N C I A L H I G H L I G H T S
revenues
(millions )
$35
$30
$25
$20
$15
$10
$5
grOss margin
75%
70%
65%
60%
97
98
99
00
01
02
03
04
05
06
97
98
99
00
01
02
03
04
05
06
Operating incOme/(LOss)
net incOme/(LOss)
( m i l l i o n s )
( m i l l i o n s )
$1.5
$1.0
$0.5
0
($0.5)
($1.0)
($1.5)
$1.5
$1.0
$0.5
0
($0.5)
($1.0)
($1.5)
97
98
99
00
01
02
03
04
05
06
97
98
99
00
01
02
03
04
05
06
Year ended december 31 ( t h o u s a n d s )
Selected Income Statement data
2004
Revenues
Gross Profit
Gross Margin
Operating Income
Net Income
Earnings Per Share
Selected Balance Sheet data
Working Capital
Total Assets
Long-Term Debt
Stockholders’ Equity
$ 26,183
$ 18,403
70.3%
1,157
927
0.10
$
$
$
2004
$ 5,296
$ 20,501
$
1,140
$ 14,813
2005
$ 30,727
$ 21,800
70.9%
$
$
$
422
55
0.01
2005
$ 5,722
$ 25,068
$
677
$ 18,536
2006
$ 34,628
$ 25,261
72.9%
$
(679)
$ (1,172)
$
(0.15)
2006
$ 38,263
$ 56,963
$
0
$ 50,699
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
C H A I r M A N ’ S A N N u A L L e T T e r
George W. LeMaitre
Chairman of the Board, president & Ceo
Dear LeMaitre Vascular Shareholder:
I’d like to use this annual report to welcome the new holders of LeMaitre vascular stock.
I’d also like to thank the 200+ pre-Ipo “pioneer” shareholders who have supported us
throughout. 2006 was another great year for your Company. In addition to our Ipo, the year
was highlighted by continued sales growth, the last of our five factory consolidations and
significant growth of our worldwide sales force. Year-over-year reported revenue growth was
3% on a GAAp basis and 7% “apples-apples” after stripping out discontinued expedial and
private label sales. our gross margin increased to 72.9% in 2006 from 70.9% in 2005, and we
ended the year with 47 bag-carrying sales reps, up from 30 at the end of 2005. As expected,
the added expenses of our growing sales force and operating as a public company caused us
to post a net loss of $.2 million in 2006 vs. $55,000 in net income in 2005.
17% “Apples-Apples” Revenue Growth to $34.6 Million
We finished 2006 with $34.6 million in revenues. our endovascular and Dialysis Access
category grew 45% in 2006 due to the high-growth profiles of these two markets, accounting
for 28% of net sales in 2006 versus 22% in 2005. We posted excellent sales results in
Germany and Japan due to our growing direct operations in these two “home away from
home” markets. We also continued our move towards direct-to-hospital sales, hiring sales
reps in Canada, Sweden and Austria for the first time. 87% of our revenues in 2006 were
direct-to-hospital versus 84% in 2005. We have pursued this direct-to-hospital strategy for
nearly a decade in order to strengthen our links with our vascular surgeon customers and to
improve our gross margin.
Factory Consolidation Improves Gross Margin to 72.9%
We posted a 72.9% gross margin in 2006, up from 70.9% in 2005. over the 2003-2006
timeframe, our five factory consolidations caused us to incur $2. million in charges. With this
consolidation program now complete, all of our manufacturing is now in Burlington. Since
200 we’ve almost tripled net sales from $2.6 million to $34.6 million, while headcount has
increased just 47% to 28 employees. And despite all the product transfers into Burlington, we
were effectively back-order free in 2006. our recently centralized manufacturing should also
enable us to drive more uniform product quality and more rapid product innovation.
Growing Commitment to Research & Development
In 2006 we launched a shorter, easier-tracking tip for our endoFit and uniFit stent
grafts. In January 2007 we also launched the pruitt F3 next generation shunt for carotid
endarterectomy. The F3 features more flexible tubing, more blood flow as well as better
identification markings and color coding.
After sales force growth and acquisitions, the #3 use of our Ipo proceeds is to more
aggressively fund our r&D efforts. As such we significantly expanded our product development
team in the back half of 2006. our 2005 stent graft acquisition provides us with a versatile
technology platform that can be applied throughout the vasculature.
Endologix European Distribution Agreement
In December 2006 we finalized a three year agreement to distribute the endologix powerlink
Stent Graft in 0 european countries. The logic of this agreement is simple and compelling for
both parties. endologix is spared the cost of developing a european distribution channel and
LeMaitre vascular is able to make more efficient sales calls. In most instances it is the same
customer who implants our endofit and unifit Stent Grafts as well as the powerlink Stent Graft.
This distribution agreement underscores our move into endovascular, where we continue to
see procedure volume growth outpace open vascular.
Private Label Cessation & Expedial Write-Off
We discontinued two product lines in 2006 and 2005 (private label and expedial). These
two items accounted for $. million in 2005 revenue. These eliminations will simplify your
2 L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
“2006 was another great year
for LeMaitre Vascular.
In addition to our IPO, the year
was highlighted by continued sales
growth, the last of our five factory
consolidations and significant
growth of our
worldwide sales force.”
Company, setting the table for future growth. We discontinued our private label packaging
business because it was a low-margin strategic misfit we assumed in the 200 Ideas For
Medicine acquisition. In the expedial acquisition I made due diligence errors in assessing the
product’s long term patency rates and the need for post-implantation support. Some small
consolation was our october 2006 sale of the product line for $350,000.
No Acquisitions in 2006
Some of the biggest LeMaitre vascular news in 2006 was that we did not execute an
acquisition. previously we had completed six acquisitions between 998 and 2005. While
our acquisition pipeline was full as 2006 dawned, we elected to focus on the Ipo instead.
Looking ahead, we fully intend to be active on the acquisition front as I believe we have
developed a special acquisition/consolidation competence. Shareholders often ask me “What
companies or products will you buy?” on the Ipo road show Dave roberts and I spent a lot of
time discussing the Yin vs. Yang powerpoint slide. The Yin/Yang symbol is meant to indicate that
we will do both revenue and technology acquisitions. We will look to acquire businesses which
address your Company’s needs at the time and we will be opportunistic in acquiring companies
at valuations where we can bring future profitability to the organization.
2007 and Beyond
our marquee accomplishment in 2006 was our october 9th Ipo. Apart from the accelerated
pace enabled by a $30 million bank account, our business plan following the Ipo still consists of
three simple strategies:
. Build our vascular sales force
2. Acquire vascular devices
3. Develop vascular devices
prior to the Ipo I believe we were hampered by a lack of capital – which made us unable
to execute on some fairly obvious investments. While we will deploy your Company’s capital
prudently, we expect the pace of change to quicken.
Thanks to our 218 Employees
I’d like to close this letter by thanking the 28 hard-working folks who comprise LeMaitre
vascular. In 2006 I was pleased to watch the entire team embrace our transition to public
ownership. A publicly-traded security will not change my commitment to our employees or my
desire to develop long-term employment relationships. on that note, I would like to express my
sincere thanks to peter Gebauer (president, International), Trent Kamke (Svp, operations) and
Dave roberts (CFo) for their ten years of service. The “Class of 997” will receive their 0-year
rolexes in 2007. Another company attribute which I believe will continue is our owner/operator
mentality – at April 30, 2007, 39% of our outstanding shares were held by the LeMaitre vascular
executive Committee and the LeMaitre family. Indeed the LeMaitre family invested an additional
$560,000 in the days following the Ipo, buying 9,86 LMAT shares in the open market.
Thanks for a great 2006! Let’s keep building LeMaitre vascular into the best vascular surgery
brand in the world!
Sincerely,
George W. LeMaitre
Chairman of the Board, president & Chief executive officer
April 30, 2007
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T 3
D e e p r o o T S ~ H I S T o r Y
Deep Roots, Fresh Water
We are a different type of company, with a different history—and a bright future.
our vascular surgeon founder, George D. LeMaitre M.D., conceived of a better way to help
patients with lower limb ischemia. In 983, after being turned away by several large device
manufacturers, Dr. LeMaitre founded a company which would eventually bring his valvulotome
to market.
Dr. LeMaitre’s valvulotome became the market leader, saving legs and sometimes lives.
Through a series of private equity placements totaling $6.4 million, LeMaitre vascular’s
ownership ranks grew to include approximately 00 vascular surgeons. As such we’ve often
referred to LeMaitre vascular as a “Surgeons’ Cooperative.” over the years, LeMaitre vascular’s
offerings grew to 0 product lines addressing a wide range of vascular surgery needs, and
revenues grew to $34.6 million in 2006.
This was LeMaitre vascular as a private company. However, we recognized that in order to
further pursue our mission of bringing innovative devices to vascular surgeons, we would
need more capital. Thus we executed our Ipo on october 9, 2006, raising $33 million in
net proceeds.
As a result of our Ipo, we are no longer the quaint “Surgeons’ Cooperative” which
Dr. LeMaitre founded. our reach and ambitions are broader and so are our means. We are
now well-positioned to benefit from our deep vascular roots — deep roots that have been
freshly watered with the Ipo proceeds.
George D. LeMaitre, M.D.
Founder, Director, &
Scientific Advisory Board Chairman
Lemaitre vascuLar tOdaY
saLes grOwth
0-year, 32% compounded annual growth rate
grOss margin
72.9%
executive cOmmittee
Median 8 years at LeMaitre vascular
vascuLar market
$3 billion, growing 8% annually
empLOYees
28, including 47 bag-carrying
sales representatives
diversified vascuLar pOrtfOLiO
0 product lines
brand strength
LeMaitre vascular ranked #2,
“most dedicated” vascular company
by uS vascular surgeons*
As of December 31, 2006
* Source: Survey of US Vascular Surgeons
conducted by LeMaitre Vascular
through Research Options, January 2006
4 L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
2006
Initial public offering
2005
endomed Acquisition
(Thoracic and Abdominal Stent Grafts)
2004
Asia-pacific Headquarters opened
in Tokyo, Japan
Commitment to the Vascular Surgeon
LeMaitre vascular was founded on the idea of serving a single customer—the vascular
surgeon—in whatever he or she does to improve patient outcomes. We understand our
customer, recognize the trends in our market, and have deep industry relationships which
help us meet clinical needs. We don’t bet on individual products or technologies, we bet on
the vascular surgeons who use them.
Experience on the Job
Any organization is a reflection of the combined efforts of its people and the results
they achieve. The 3 members of our executive Committee have a median tenure at
LeMaitre vascular of eight years. Lessons learned are not lessons lost. We have become
particularly adept in several areas: acquisition, consolidation, and the geographic expansion
of our sales force.
2001
Ideas for Medicine Acquisition
(Carotid Shunts)
Company Name Changed to LeMaitre vascular
1997
International Headquarters opened
in Frankfurt, Germany
1992
George W. LeMaitre
Joins vascutech
1985
First valvulotome Sold
1983
vascutech Founded
by George D. LeMaitre, MD
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T 5
Rooted in the vascular community – serving the vascular surgeon since 1983.
G r o W I N G S T r o N G ~ e X p A N S I o N
wOrLdwide saLes representatives
Expanding our Sales Reach…
Growing a World Class Brand
our sales force has been built slowly since 999. We have carefully selected sales
representatives whom vascular surgeons trust—not only in the hallway but in the operating
room. Many of our devices require vascular surgeons to adopt new techniques - thus they
rely on us to train and advise them during procedures.
We began our sales force in the united States and Germany and have gradually
expanded throughout Western europe and Japan. As of December 3, 2006, we had
47 bag-carrying sales representatives calling on vascular surgeons in cities like New York,
Los Angeles, London, Frankfurt, Munich and Tokyo. In 2006 3,500 hospitals in nine countries
ordered products directly from us. While 87% of our sales are direct-to-hospital, to expand our
00
01
02
03
04
05
06
global reach we also sell through distributors in an additional 55 countries on six continents.
50
40
30
20
10
97
99
As of December 31
98
2006 revenues bY saLes channeL
…and our Brand Name
We’ve always thought of LeMaitre vascular as a worldwide brand. our brand is well known to
our customers because of our direct mail heritage, our steady advertising in medical journals,
our expanding direct sales presence, and our long history of manufacturing quality medical
devices. In 2006, a Company-sponsored, independently-conducted survey suggested that our
brand awareness among u.S. vascular surgeons is on par with medical device companies
0 to 00 times our size. our name is our most precious asset.
13% Distributors
87% Direct-to-Hospital
Lemaitre vascuLar: #2 “mOst dedicated” vascuLar cOmpanY
(% R e c o g nizing c ompany among “m os t d e dicate d”)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
r
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6 L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
Source: Survey of US Vascular Surgeons conducted by LeMaitre Vascular through Research Options, January 2006
LeMaitre Vascular’s Global Reach
Corporate Headquarters & Manufacturing
Burlington, Massachusetts
International Headquarters
Sulzbach, Germany
Asia-Pacific Headquarters
Tokyo, Japan
LeMaitre Vascular Sales Representatives
LeMaitre Vascular Distributors
As of December 31, 2006
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T 7
B r A N C H I N G o u T ~ D I v e r S I F I C A T I o N
We seek to expand our offerings
Rooted in Experience
through acquisition and product
development. Diversifying our
product portfolio improves and
Our Surgeons’ Cooperative
We were founded by a vascular surgeon, and a large number of our pre-Ipo “pioneer”
shareholders were vascular surgeons. Following our Ipo, we’re no longer calling ourselves
a “Surgeons’ Cooperative”, but we maintain unique access to a broad network of surgeon
stabilizes our revenue stream
advisors who help us to improve our research efforts and make smarter acquisitions.
while enabling significant
cross-selling opportunities.
Experienced Acquiror
From 998 to 2005, we completed six acquisitions for an aggregate consideration of
$4.9 million in cash, assumed debt, and stock. The acquired product lines now account
for more than two-thirds of our revenues.
acQuisitiOn track recOrd
Experienced Consolidator and Manufacturer
(millions )
In 2006 we finished the consolidation of these six acquisitions into our Burlington,
$35
$30
$25
$20
$15
$10
$5
Massachusetts headquarters—from locations as diverse as France, Wales, Arizona, and
Florida. our in-house manufacturing competencies now include epTFe extrusion, plastic
molding, latex balloon formation, printing, and assembly. We did not have any significant
product backorders in 2006, and our gross margin improved for the fifth consecutive year.
Research and Development
our research and development efforts are focused on improvements and additions to
our endovascular and dialysis access product lines. Following our Ipo, we have expanded
97
98
99
00
01
02
03
04
05
06
our r&D department significantly.
Organic Products
Leveraging Acquisitions
Technology Acquisitions
8 L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
Acquisition Consolidation
(year acquired year consolidated)
1998 2002
VascuTape Radiopaque Tape
Lawrence, Massachusetts
1999 2004
LeMaitre Embolectomy Catheters
OptiLock Implantable Port
Neuilly-en-Thelle, France
2001 2005
Pruitt-Inahara Carotid Shunt
Reddick Cholangiogram Catheter
LeMaitre Embolectomy Catheters
St Petersburg, Florida
manufacturing OperatiOns, burLingtOn, massachusetts
2003 2006
Expedial Vascular Access Graft
Brymbo, Wales
2004 2004
AnastoClip Vessel Closure System
Norwalk, Connecticut
2005 2006
EndoFit Thoracic Stent Graft
UniFit Abdominal Stent Graft
Phoenix, Arizona
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T 9
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T 9
B r A N C H I N G o u T ~ D I v e r S I F I C A T I o N
We intend to add to our
Saving Lives
product offerings in both
The endoFit Thoracic Stent Graft treats aortic aneurysms and aortic dissections, pathologies
vascular surgery and
endovascular surgery.
that often lead to rupture of the aorta and/or death if left untreated. prior to the endovascular
revolution, aneurysms and dissections were treated by highly invasive surgery. Stent grafts, in
contrast, are introduced into the vasculature through a small incision in the groin and reinforce
the aorta from within. endoFit’s flexible, sandwich-like design minimizes contact between the
nitinol stents and the blood stream. endoFit’s easy-to-manufacture design also allows us to
offer a wide range of sizes, including tapered grafts. In addition, our use of hydrogen peroxide
sterilization allows us to rapidly build customized devices; approximately 34% of our stent
grafts were custom made in 2006. If we were a tailor we could offer custom-fit or off-the-rack
suits. The endoFit Thoracic Stent Graft is currently sold in the european union. We are also
conducting a clinical study in China in the hopes of attaining marketing approval.
Preserving Access
patients with end-stage renal disease undertake a regimen of dialysis, requiring an access
site through which their blood is drawn and filtered. unfortunately, these access sites
usually require frequent interventions to remain open. our AnastoClip vessel Closure System
is designed to extend the useful life of these access sites by creating “compliant” vessel
attachments that allow for expansion and contraction. A ,0-patient two-year study
published in the Journal of vascular Surgery in 2003 found that our AnastoClip improves
two-year patency 20% versus traditional sutures.
Saving Legs
Dr. LeMaitre’s valvulotome removes valves from the saphenous vein, a vessel that runs from
the ankle to the groin. The expandable LeMaitre valvulotome (sixth generation) reduces costs
for hospitals by enabling less-invasive bypass surgery; a few one-inch incisions suffice rather
than an ankle-to-groin cut. This “semi-closed” approach reduces hospital stays and wound
complications. The expandable LeMaitre valvulotome is the only valvulotome with a self-sizing,
self-centering mechanism.
0 L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
endoFit Thoracic Stent Graft
AnastoClip vessel
Closure System
uniFit Abdominal Stent Graft
& endologix powerlink Stent Graft
expandable LeMaitre valvulotome
pruitt-Inahara
Carotid Shunt
LeMaitre
embolectomy Catheters
vascuTape
radiopaque Tape
InvisiGrip vein Stripper
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
N e W G r o W T H ~ o p p o r T u N I T Y
Market Opportunities
Sales from our 0 product lines totaled $34.6 million in 2006. Industry research indicates that
the potential market for those devices is approximately $500 million. This indicates a 7% market
share for LeMaitre vascular. We estimate the entire market for vascular devices is approximately
$3 billion and growing 8% annually, due to the increase in the incidence and diagnosis of
peripheral vascular disease, the shift to higher-priced endovascular devices, and the adoption of
western healthcare standards
vascular surgeons are increasingly adopting new endovascular techniques that are minimally
invasive and involve repairing vessels from within. Due to reduced hospital stays, endovascular
devices command significantly higher prices than open vascular devices. Because our brand is
vascular surgeon-centric, we expect to benefit from this rotation into endovascular surgery.
We intend to grow share in our
$500 million addressable market
by building our sales force and
(millions ) u nau dite d
mix shifting tO endOvascuLar & diaLYsis access
developing refinements to our
existing product lines. We will
seek to enter the balance of the
$3 billion vascular market via
acquisition and development.
$35
$30
$25
$20
$15
$10
$5
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06
Endovascular
& Dialysis
Access
Vascular
General Surgery
}
}}
2 L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
Opportunities for Internal Growth
Our revenues & Our market
Within our existing $500 million market, we have ample opportunity to grow. our Ipo has
(millions )
provided us with the means to expand our sales force in our direct-to-hospital markets: the
united States, europe, and Japan. It also allows us to initiate direct-to-hospital coverage in a
number of international markets where we currently sell through distributors. We believe
direct-to-hospital sales enable closer customer relationships, higher selling prices and gross
margins, and are not subject to the end-customer churn associated with distributor turnover.
A direct sales force benefits the top line. In the accompanying chart, compare Germany,
where we hired our first sales representative in 997, and France, where we have sold
direct-to-hospital but have not yet hired a sales force. our German sales have posted a
58% compounded annual growth rate over 0 years versus 4% in France.
$3,000
$2,900
$2,800
$500
$400
$300
$200
$100
0
$3b
$500.0
$34.6
2006
Revenues
Addressable Market
(10 Products)
Peripheral Vascular
Device Market
fiLLing Open territOries - a case studY
Our $500 miLLiOn addressabLe market
(millions ) u nau dite d
(millions )
$5.0
$4.0
$3.0
$2.0
$1.0
G E R M A N y : + 7 S A L E S R E P R E S E N T A T I V E S
$4.5
$600
$500
$400
$300
$200
$100
$.07
$.02
FRANCE: +0 SALES REPRESENTATIVES
$0.4
97
98
99
00
01
02
03
04
05
06
97
98
99
00
01
02
03
04
05
06
Management Estimate and IMS Data
For market size illustration, all years are based on
2006 market size internal estimates for current products.
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T 3
N e W G r o W T H ~ o p p o r T u N I T Y
We continue to bring our
UniFit Abdominal Stent Graft (U.S. Clinical Study)
innovative technologies
When we acquired endomed in February 2005, we took over a phase I pilot study being
to new geographies.
conducted to establish the safety of the uniFit Abdominal Stent Graft. The resulting data was
sufficient for the u.S. Food and Drug Administration to conditionally approve a pivotal,
phase II follow-up. We will shortly begin enrolling patients in this pivotal trial, the uNITe study.
EndoFit Thoracic Stent Graft (Chinese Clinical Study)
In August 2005, we began a clinical study to obtain approval from the Chinese State Food and
Drug Administration, or SFDA, for our endoFit Thoracic Stent Graft. We completed enrollment
of the planned 30 patients in November, 2006. After the requisite six month follow-up period,
we will begin to submit our application to the SFDA for marketing approval.
Endologix Powerlink System - European Distribution
In December 2006, we entered into a three-year distribution agreement with endologix, Inc.
This agreement gives LeMaitre vascular exclusive distribution of the powerlink System, a
bifurcated abdominal stent graft, in 0 european countries. The powerlink System addresses
a market in excess of $50 million in these 0 european countries, expands our participation in
the endovascular stent graft market, and leverages our growing direct sales force in europe.
regulatory approvals
u.s.
europe
Japan
Endovascular
& Dialysis
Access
endoFit Thoracic Stent Graft
uniFit Aortic Stent Graft
vascuTape radiopaque Tape
AnastoClip vessel Closure System
expandable LeMaitre valvulotome
Vascular
General
Surgery
pruitt-Inahara Carotid Shunt
InvisiGrip vein Stripper
LeMaitre embolectomy Catheters
reddick Cholangiogram Catheter
optiLock Implantable port
In Trial
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Applied
•
Applied
4 L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T 5
L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T 5
e X e C u T I v e C o M M I T T e e
Back row, left to right: Trent G. Kamke, Aaron M. Grossman, Nobuhiro okabe, Kevin D. Kelly, Maik D. Helmers, peter r. Gebauer, David B. roberts.
Front row, left to right: Joseph p. pellegrino, Jr., George W. LeMaitre, Kimberly L. Cieslak, Jonathan W. Ngau, ryan H. Connelly, Cornelia W. LeMaitre.
executive committee
george w. Lemaitre
Chairman of the Board,
president & Chief executive officer
kimberly L. cieslak
vice president, Marketing
maik d. helmers
Jonathan w. ngau
vice president, Central european Sales
vice president, Information Technology
ryan h. connelly
trent g. kamke
Director, research & Development
Senior vice president, operations
nobuhiro Okabe
Country Manager, Japan
peter r. gebauer
president, International
aaron m. grossman
kevin d. kelly
Joseph p. pellegrino, Jr.
vice president, North American Sales
executive vice president, Finance
cornelia w. Lemaitre
david b. roberts
Chief Financial officer
vice president, General Counsel & Secretary
vice president, Human resources
6 L e M A I T r e v A S C u L A r 2 0 0 6 A N N u A L r e p o r T
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
È ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2006
OR
‘ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from
to
.
Commission File Number 001-33092
LEMAITRE VASCULAR, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or organization)
04-2825458
(I.R.S. Employer Identification No.)
63 Second Avenue, Burlington, Massachusetts
(Address of principal executive offices)
01803
(Zip Code)
Registrant’s telephone number, including area code 781-221-2266
Securities registered under Section 12(b) of the Act:
Title of Each Class
Name of Each Exchange on Which Registered
Common Stock, $0.01 par value per share
The NASDAQ Stock Market LLC
Securities registered under Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes: ‘ No: È
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the
Act. Yes: ‘ No: È
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period than the registrant was required
to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes: È No: ‘
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein,
and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form10-K or any amendment to this Form 10-K. È
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer
(as defined in Rule12b-2 of the Exchange Act)
Large accelerated filer ‘
Accelerated filer ‘
Non-accelerated filer È
Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange
Act) Yes: ‘ No: È
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based
on the last sale price for such stock on June 30, 2006: Not applicable. Trading of the registrant’s Common Stock on The
NASDAQ Global Market did not commence until October 19, 2006. At March 28, 2007, the Registrant had 15,353,089
shares of Common Stock, par value $0.01 per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Part III of this Form 10-K incorporates information by reference from the registrant’s definitive proxy statement to be
filed with the Securities and Exchange Commission within 120 days after the close of the fiscal year covered by this annual
report.
LEMAITRE VASCULAR
2006 FORM 10-K ANNUAL REPORT
TABLE OF CONTENTS
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unresolved Staff Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Submission Of Matters to a Vote of Security Holders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART II
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases
of Equity Securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selected Financial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Management’s Discussion and Analysis of Financial Condition and Results of Operations . . .
Quantitative and Qualitative Disclosures About Market Risk . . . . . . . . . . . . . . . . . . . . . . . . . .
Financial Statements and Supplementary Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes In and Disagreements With Accountants on Accounting and Financial
Disclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Directors, Executive Officers and Corporate Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Executive Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Certain Relationships and Related Transactions, and Director Independence . . . . . . . . . . . . . .
Principal Accounting Fees and Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART IV
Item 15.
Exhibits, Financial Statements Schedules and Reports on Form 8-K . . . . . . . . . . . . . . . . . . . .
SIGNATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
EX-21.1 SUBSIDIARIES OF THE REGISTRANT
EX-23.1 CONSENT OF ERNST & YOUNG LLP, INDEPENDENT REGISTERED PUBLIC
2
21
43
43
44
44
45
48
49
62
63
63
64
64
65
65
65
65
65
66
68
ACCOUNTING FIRM
EX-31.1 SECTION 302 CERTIFICATION OF THE C.E.O.
EX-31.2 SECTION 302 CERTIFICATION OF THE C.F.O.
EX-32.1 SECTION 906 CERTIFICATION OF THE C.E.O.
EX-32.2 SECTION 906 CERTIFICATION OF THE C.F.O.
PART I
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of the federal
securities laws that involve substantial risks and uncertainties. All statements, other than statements of historical
facts, included in this Annual Report on Form 10-K regarding our strategy, future operations, future financial
position, future net sales, projected costs, projected expenses, prospects and plans and objectives of management
are forward-looking statements. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,”
“plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying words. We have based these forward-
looking statements on our current expectations and projections about future events. Although we believe that the
expectations underlying any of our forward-looking statements are reasonable, these expectations may prove to
be incorrect and all of these statements are subject to risks and uncertainties. Should one or more of these risks
and uncertainties materialize, or should underlying assumptions, projections or expectations prove incorrect,
actual results, performance or financial condition may vary materially and adversely from those anticipated,
estimated or expected. We have identified below some important factors that could cause our forward-looking
statements to differ materially from actual results, performance or financial conditions:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
the unpredictability of our quarterly net sales and results of operations;
the ability to keep pace with a rapidly evolving marketplace and to develop or acquire and then
successfully market new and enhanced products;
a highly competitive market for medical devices;
the effect of a disaster at our manufacturing facility;
the loss of any significant suppliers, especially sole-source suppliers;
our inability to adequately grow our operations and attain sufficient operating scale;
our inability to obtain adequate profit margins;
our inability to effectively protect our intellectual property and not infringe on the intellectual property
of others;
possible product liability lawsuits and product recalls;
inadequate levels of third-party reimbursement to healthcare providers;
our ability to initiate, complete or achieve favorable results from clinical studies of our products;
our ability to obtain and maintain U.S. and foreign regulatory clearance for our products and our
manufacturing operations;
our inability to raise sufficient capital when necessary or at satisfactory valuations;
loss of key personnel; and
other factors discussed elsewhere in this Annual Report on Form 10-K.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking
statements and you should not place undue reliance on our forward-looking statements. We have included
important factors in the cautionary statements included in this Annual Report on Form 10-K, particularly in the
section entitled “Risk Factors,” that we believe could cause actual results or events to differ materially from the
forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of
any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume
any obligation to update any forward-looking statements, whether as a result of new information, future events or
otherwise, except as required by law.
1
Unless the context requires otherwise, references to “LeMaitre Vascular,” “we,” “our” and “us” in this Annual
Report on Form 10-K refer to LeMaitre Vascular, Inc. and its subsidiaries.
LeMaitre, Pruitt-Inahara, EndoFit, VascuTape, Expandable LeMaitre Valvulotome, Glow ‘N Tell, Reddick,
Expedial, OptiLock, InvisiGrip, Pruitt, AnastoClip and the LeMaitre Vascular logo are registered trademarks of
LeMaitre Vascular, and UniFit and F3 are unregistered trademarks of LeMaitre Vascular. This Annual Report
on Form 10-K also includes the registered and unregistered trademarks of other persons.
Item 1.
Business
Overview
LeMaitre Vascular is a global provider of medical devices for the treatment of peripheral vascular disease.
We develop, manufacture and market disposable and implantable vascular devices to address the needs of
vascular surgeons and interventionalists. Our diversified portfolio of peripheral vascular devices consists of
brand name products that are used in arteries and veins outside of the heart and are well known to vascular
surgeons, including the Expandable LeMaitre Valvulotome and the Pruitt-Inahara Carotid Shunt.
We have grown our business by using a three-pronged strategy: building a worldwide direct sales force,
acquiring complementary vascular devices and developing and enhancing our in-house manufacturing
competencies. Since 1998 we have completed six acquisitions and completed the integration of each of these
acquisitions, consolidating all of our manufacturing operations into our Burlington, Massachusetts headquarters.
We have sought to take advantage of the trend towards endovascular techniques and other innovative
procedures that utilize more complex, higher priced devices by acquiring new product lines. For example, we
recently acquired our EndoFit and UniFit Aortic Stent Grafts, which are endovascular devices used to treat aortic
aneurysms and dissections. Our vascular surgeon customers are increasingly performing minimally invasive
endovascular procedures, presenting us with attractive opportunities to sell new devices that address their
changing product needs.
We estimate that peripheral vascular disease affects more than 20 million people worldwide. We estimate
that the annual worldwide market for all peripheral vascular devices exceeds $3 billion and that the annual
worldwide market addressed by our ten current product lines exceeds $500 million. In addition, we distribute an
additional product line of a third party that addresses a market that we estimate to be in excess of $50 million in
the territories where we have exclusive distribution rights. The increasing incidence and diagnosis of peripheral
vascular disease is driving the growth of the market for peripheral vascular devices, which we estimate is
growing at 8% per year. We believe that our strong brands, expanding suite of peripheral vascular devices and
broad network of vascular surgeon customers uniquely position us to capture an increasing share of this large and
growing market.
We sell our products primarily through a direct sales force. Our sales force was comprised of 47
bag-carrying sales representatives in the United States, Canada, the European Union and Japan as of
December 31, 2006. We also sell our products through a network of distributors in various countries outside of
the United States and Canada. For the year ended December 31, 2006, approximately 87% of our net sales were
generated through direct sales, and no customer accounted for more than approximately 4% of our net sales.
Corporate Information
We were incorporated in Massachusetts on November 28, 1983 as Vascutech, Inc. On June 16, 1998 we
were reincorporated in Delaware, and on April 6, 2001 we changed our name to LeMaitre Vascular, Inc. Our
principal executive offices are located at 63 Second Avenue, Burlington, Massachusetts 01803, and our telephone
number is (781) 221-2266.
2
Where You Can Find More Information
Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act
of 1934 are available through the investor relations portion of our website (ir.lemaitre.com) free of charge as
soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and
Exchange Commission, or SEC. Information on our investor relations page and on our website is not part of this
Annual Report on Form 10-K or any of our other securities filings unless specifically incorporated herein by
reference. In addition, our filings with the Securities and Exchange Commission may be accessed through the
Securities and Exchange Commission’s Electronic Data Gathering, Analysis and Retrieval (EDGAR) system at
www.sec.gov. All statements made in any of our securities filings, including all forward-looking statements or
information, are made as of the date of the document in which the statement is included, and we do not assume or
undertake any obligation to update any of those statements or documents unless we are required to do so by law.
Industry Background
We estimate that peripheral vascular disease affects more than 20 million people worldwide, including
twelve million people in the United States and seven million people in Europe. The disease encompasses a
number of conditions in which the arteries or veins that carry blood to or from the legs, arms or organs other than
the heart become narrowed, obstructed, weakened or otherwise compromised. In many cases peripheral vascular
disease goes undetected, sometimes leading to life-threatening events—such as stroke, ruptured aneurysm, or
pulmonary embolism—or death.
Clinical studies have identified several factors that increase the risk of peripheral vascular disease, including
smoking, diabetes, obesity, high blood pressure, lack of exercise, coronary artery disease, high cholesterol and
being over the age of 65. Demographic trends suggest an increase in the prevalence of peripheral vascular disease
over time, driven primarily by rising levels of obesity and diabetes and an aging population.
The growing prevalence of diabetes, among other factors, has also led to an increase in the number of
people suffering from end-stage renal disease. Patients with end-stage renal disease require a regular regimen of
dialysis, an intravenous therapy that removes toxins and excess fluids from the bloodstream. Dialysis frequently
requires the patient to undergo vascular procedures to create and preserve vessel access sites.
The Vascular Device Market and the Role of the Vascular Surgeon
We estimate that the worldwide market for peripheral vascular devices exceeds $3 billion. We believe this
market is growing due to the increase in the incidence and diagnosis of peripheral vascular disease, the shift to
higher priced endovascular devices and the adoption of western healthcare standards by the developing world.
Vascular surgeons primarily treat peripheral vascular disease, but also perform vascular procedures
associated with other diseases, such as end-stage renal disease. In the United States there are more than 2,000
board-certified vascular surgeons and several thousand general surgeons who perform vascular procedures. We
estimate there are more than 3,000 vascular surgeons in Europe and Japan. In contrast to interventional
cardiologists and interventional radiologists, neither of whom are certified to perform open surgical procedures,
vascular surgeons can perform both open surgical and minimally invasive endovascular procedures and are
therefore uniquely positioned to provide patients with a wider range of treatment options.
Conventional vascular surgery involves opening the body, cutting vessels and suturing, and include
procedures such as lower extremity bypass surgery, carotid endarterectomy and abdominal aneurysm repair.
Vascular surgery is often invasive and requires extended hospital stays. In contrast, endovascular procedures
typically are minimally invasive and involve repairing vessels from within. Catheter-based devices are inserted
through a small incision and are directed with the assistance of real-time imaging technologies. Typical
endovascular procedures include angioplasty, stenting, stent-grafting and atherectomy.
3
Vascular surgeons are increasingly adopting new endovascular techniques. According to the Healthcare
Cost and Utilization Project, of the 1.1 million surgical procedures for peripheral vascular disease performed in
the United States in 2003, over 38% were endovascular procedures, as compared to 25% in 1997. Due in part to
the reduced hospital stays that they enable, endovascular devices typically command significantly higher prices
than vascular surgery devices.
We believe that the purchasing volume of the vascular surgeon will continue to increase as a result of these
trends. Given our long-term focus on the vascular surgeon, we believe we are well-positioned to address the
needs of this attractive target customer.
Our History
We were founded in 1983 by George D. LeMaitre, M.D., a vascular surgeon who designed and developed
the predecessor to our Expandable LeMaitre Valvulotome. We sold this device exclusively during the 1980s, and
in 1992 we generated annual net sales of $0.8 million. We accomplished this with four employees, sharing space
with Dr. LeMaitre’s private surgical practice in Andover, Massachusetts.
In 1992, George W. LeMaitre, our Chairman, President and Chief Executive Officer, and Dr. LeMaitre’s
son, joined LeMaitre Vascular with a vision of creating a company focused on serving the broader needs of the
vascular surgeon. Throughout most of the 1990s, we used cash generated from operations and a nominal amount
of bank debt to fund the further development of the valvulotome and to establish the LeMaitre Vascular brand. In
1997, we generated annual net sales of $3.0 million with 15 employees.
Beginning in 1998, we initiated a strategic plan to accelerate our growth through the execution of three key
initiatives:
•
•
•
build a worldwide direct sales force;
acquire complementary vascular devices; and
develop in-house manufacturing and assembly capabilities.
In order to execute on these three initiatives, we raised $16.4 million of equity capital through a series of
financing rounds from 1998 to 2005. From 1998 to 2005, we completed six acquisitions for an aggregate
consideration of $14.9 million in cash, assumed debt and stock. Seven of our ten product lines were acquired via
these acquisitions. We have completed the integration of each of these product lines and businesses,
consolidating all of our manufacturing operations into our Burlington, Massachusetts headquarters.
In October 2006, we completed our initial public offering, raising net proceeds of approximately
$36 million, before expenses. In December 2006, we entered into a three-year distribution agreement with
Endologix, Inc., effective January 1, 2007, for the exclusive distribution of the Powerlink System—an abdominal
stent graft manufactured by Endologix—in ten European countries, including Germany, France and the United
Kingdom. The Powerlink System expands our participation in the endovascular stent graft market and leverages
our growing direct sales force in Europe. For the year ended December 31, 2006, we generated net sales of $34.6
million, and we currently offer ten product lines across three product categories, excluding Powerlink.
4
Our Business Strategies
Our goal is to be the leading global provider of medical devices to vascular surgeons and interventionalists.
To achieve this objective, we are utilizing the following strategies:
• Further Expand Our Direct Sales Force in the United States, the European Union and Japan. We
sell our products primarily through a direct sales force comprised as of December 31, 2006 of 47
bag-carrying sales representatives in the United States, Canada, the European Union and Japan. We
intend to accelerate the expansion of our sales force in these markets. We also intend to convert
selected countries from distributor to direct sales. We believe that direct-to-hospital sales engender
closer customer relationships, allow for higher selling prices and gross margins and are not subject to
the risk of customer churn resulting from distributor turnover.
• Add Complementary Products through Acquisitions. We believe our significant experience in
acquiring and integrating product lines and businesses is one of our principal competitive advantages.
Since 1998, we have completed six acquisitions. We actively track industry developments and plan to
acquire additional product lines and businesses as a means of further accessing the $3 billion peripheral
vascular device market. We intend to pursue acquisitions in a disciplined manner to expand and
diversify our product offerings and add new technology platforms.
• Extend Our Market Reach through Research and Development and Additional Regulatory
Approvals. By refining our current product lines and developing new applications for our existing
technologies, we plan on extending our reach into the $3 billion peripheral vascular device market. Our
current research and development efforts include improvements and additions to our endovascular and
dialysis access product lines. We also intend to obtain regulatory approvals for our devices in new
markets. For example, we currently market our aortic stent graft devices in the European Union and
have focused our near-term efforts on obtaining regulatory approval for these products in the
United States for our UniFit Abdominal Stent Graft—currently sold under the EndoFit trademark
pending regulatory approval of its rebranding—and in China for our EndoFit Thoracic Stent Graft.
5
Our Products
The following table describes the primary use and regulatory status of each of our ten product lines:
Product Category
Endovascular &
Dialysis Access
Vascular
General Surgery
Product Line
Primary Use
EndoFit Thoracic
Stent Graft
UniFit Abdominal
Stent Graft
VascuTape
Radiopaque Tape
AnastoClip Vessel
Closure System
Expandable LeMaitre
Valvulotome
Pruitt-Inahara and
Pruitt F3 Carotid
Shunts
InvisiGrip Vein
Stripper
LeMaitre Balloon
Catheters
Reddick
Cholangiogram
Catheter
OptiLock Implantable
Port
Endovascular repair of
thoracic aortic
aneurysm and
dissection
Endovascular repair of
abdominal aortic
aneurysm
Improvement in
precision and
accuracy of
endovascular
procedures
Attachment of blood
vessels, primarily for
dialysis access
Destruction of vein
valves to create vein
bypass graft
Facilitation of blood
flow to brain during
carotid plaque
removal
Single-incision
removal of varicose
veins
Removal of blood
clots; occlusion and
facilitation of blood
flow
Introduction of dye
into the cystic duct
Central venous
infusion of drugs and
nutrients
Available for Sale in
United
States
European
Union
✓
Japan
In clinical
studies(1)
✓(2)
✓
✓
✓
✓
✓
✓
✓
✓(3)
✓(3)
Application
submitted(4)
✓
Application
submitted(4)
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
(1) We are conducting a clinical study in the United States on the UniFit Abdominal Stent Graft. See
“—Clinical Studies” for a description of this clinical study.
(2) The UniFit Abdominal Stent Graft is currently sold in the European Union under the EndoFit trademark,
pending regulatory approval of its rebranding.
(3) The Pruitt F3 Carotid Shunt is only available for sale in the United States.
(4) We have submitted an application for Shonin registration to be filed with the Japan Ministry of Health,
Labor and Welfare.
6
In addition, effective January 1, 2007, we became the exclusive distributor for the Powerlink System—an
abdominal stent graft manufactured by Endologix, Inc.—in ten European countries, including Germany, France
and the United Kingdom. We believe that this product complements our EndoFit Thoracic Stent Graft and UniFit
Abdominal Stent Graft product lines, allowing our growing European sales force to offer a complete range of
stent grafts for the entire aorta.
Endovascular & Dialysis Access Products
Endovascular
Our endovascular products are used by vascular surgeons and interventionalists in minimally invasive
endovascular procedures, such as angioplasty, stenting, stent-grafting and atherectomy.
EndoFit Thoracic Stent Graft
The EndoFit Thoracic Stent Graft is a line of endovascular grafts used to treat an aortic aneurysm, a
weakening and ballooning of the aorta, or an aortic dissection, a separation of the layers of the aortic wall that
often leads to rupture and death, in each case in the upper part of the aorta, known as the thoracic aorta.
EndoFit’s flexible, encapsulated design, in contrast to devices currently available commercially, uses ePTFE, or
expanded polytetrafluoroethylene, which is designed to prevent stent scaffolding from contacting either the blood
stream or the vessel wall. This design also allows us to offer a wide range of stent grafts sizes, including tapered
grafts, which fit a wider range of patient anatomies than many of our competitors’ products. Our design also
allows us to rapidly build the device to fulfill custom orders, and, for the year ended December 31, 2006, about
34% of our EndoFit and UniFit stent grafts were custom-made. We acquired our EndoFit product line through
our acquisition of Endomed in February 2005.
Our EndoFit Thoracic Stent Graft product line is currently sold in the European Union and a small number
of foreign jurisdictions. We are currently conducting a clinical study in China for the EndoFit device.
UniFit Abdominal Stent Graft
The UniFit Aorta-uni-iliac Stent Graft is a line of non-bifurcated endovascular grafts used to treat
aneurysms in the lower part of the aorta, known as the abdominal aorta, and the iliac arteries. The UniFit device
is similar in design to the EndoFit device, with a flexible, encapsulated design and similar manufacturing
advantages that allows us to offer a wide range of stent graft sizes and custom-built devices. We acquired our
UniFit product line through our acquisition of Endomed in February 2005. Until recently we referred to this
product as part of our EndoFit line of endovascular grafts, but are in the process of rebranding the device as
UniFit to more accurately reflect that it is a different product line indicated for use in a different section of the
aorta.
This product line is currently sold in the European Union and a small number of foreign jurisdictions under
the EndoFit trademark pending completion of the rebranding. We are currently conducting a pivotal study in the
United States for the UniFit device.
VascuTape Radiopaque Tape
VascuTape Radiopaque Tape is a flexible, medical-grade tape with centimeter or millimeter markings
printed in our proprietary radiopaque ink that is visible both to the eye and to an x-ray machine or fluoroscope.
VascuTape Radiopaque Tape is applied to the skin and provides vascular surgeons and interventionalists with a
simple way to cross-reference precisely between the inside and the outside of a patient’s body, allowing them to
accurately size or locate tributaries or lesions beneath the skin. VascuTape Radiopaque Tape enables smaller skin
incisions, more accurate lesion location, more precise stent and catheter sizing and reduced contrast injections.
7
VascuTape Radiopaque Tape was invented by our founder, George D. LeMaitre, M.D., and received 510(k)
clearance from the United States Food and Drug Administration, or FDA, in 1993.
Our VascuTape product line is currently sold in the United States, the European Union, Japan and many
other foreign jurisdictions.
Powerlink System
The Powerlink System is a one-piece, self-expandable bifurcated stent graft. The Powerlink System’s
unique delivery mechanism requires only a surgical incision in one leg, whereas other bifurcated stent grafts
typically need surgical exposure of the femoral artery in both legs to introduce multiple components.
The Powerlink System is manufactured by Endologix, Inc. and distributed by us in select European markets,
including Germany, France and the United Kingdom.
Dialysis Access
Dialysis is an intravenous therapy, typically performed three or more times per week, that removes toxins
and excess fluids from the bloodstream in end-stage renal disease patients. Dialysis requires access to the
patient’s bloodstream through large needles or catheters. Our dialysis access product is used in surgical
procedures that facilitate the creation of dialysis access sites, typically in a patient’s arm. Vascular surgeons
perform a critical role in the care and treatment of end-stage renal disease by creating and maintaining these
access sites.
AnastoClip Vessel Closure System
The AnastoClip Vessel Closure System is a titanium clip implanted by vascular surgeons to attach vessels,
native and prosthetic, to each other. The AnastoClip Vessel Closure System creates an interrupted anastomosis,
or a vessel attachment that expands and contracts as the vessel pulses, which we believe improves the durability
of the anastomosis. The AnastoClip Vessel Closure System has the further advantage that it does not puncture the
vessel wall and disrupt blood flow. A retrospective 1,110-patient clinical study published in the August 2003
Journal of Vascular Surgery found that the AnastoClip Vessel Closure System improved 24-month patency
versus traditional continuous sutures from approximately 34% to 54% in arterio-venous fistulae, which are
surgical attachments of arteries and veins, and from approximately 17% to 36% in prosthetic grafts attachments.
Patency data was collected from a total of 1,385 vascular access anastomoses. We acquired the AnastoClip
Vessel Closure System product line and related operations from Tyco Healthcare in February 2004.
Our AnastoClip Vessel Closure System product line is currently sold in the United States, the European
Union, Japan and many other foreign jurisdictions.
Vascular Products
Our vascular products are used primarily in open vascular surgery for the treatment of peripheral vascular
disease.
Expandable LeMaitre Valvulotome
The Expandable LeMaitre Valvulotome cuts valves in the saphenous vein, a vein that runs from the ankle to
the groin, so that it can function as a bypass vessel to carry blood past diseased arteries to the lower leg or the
foot. The Expandable LeMaitre Valvulotome is the only self-sizing, self-centering valvulotome available. We
believe the Expandable LeMaitre Valvulotome reduces costs for hospitals by enabling less invasive bypass
surgery to be performed with several one-inch incisions rather than one continuous ankle-to-groin incision,
8
thereby reducing the length of hospital stays and the likelihood of wound complications. The Expandable
LeMaitre Valvulotome is the sixth generation of the fixed-diameter valvulotome developed by our founder,
George D. LeMaitre, M.D.
Our Expandable LeMaitre Valvulotome product line is currently sold in the United States, the European
Union, Japan and many other foreign jurisdictions.
Pruitt-Inahara and Pruitt F3 Carotid Shunts
The Pruitt-Inahara and Pruitt F3 Carotid Shunts are used to temporarily divert, or shunt, blood to the brain
while the surgeon removes plaque from the carotid artery in a carotid endarterectomy surgery. Our shunts feature
occlusion balloons which eliminate the need for clamps, thereby reducing vessel trauma. We acquired the Pruitt-
Inahara Carotid Shunt product line and related operations from Horizon Medical in March 2001. We introduced
the Pruitt F3, our next-generation model of the Pruitt-Inahara Carotid Shunt, in January 2007.
Our Pruitt-Inahara Carotid Shunts are currently sold in the United States, the European Union, Japan and
many other foreign jurisdictions. Our Pruitt F3 Carotid Shunts are currently sold in the United States.
InvisiGrip Vein Stripper
The InvisiGrip Vein Stripper is a single-incision, inversion vein stripper, which is designed to provide a less
traumatic alternative to standard vein strippers for the removal of the saphenous vein. Our InvisiGrip device
enables the surgeon to complete the procedure in a minimally invasive fashion with just one incision versus a
traditional two-incision procedure. We developed this device internally based on a patent we licensed from
Robertus Welten, M.D., a vascular surgeon.
Our InvisiGrip product line is currently sold in the United States, the European Union and many other
foreign jurisdictions.
LeMaitre Embolectomy Catheters and Pruitt Occlusion and Perfusion Catheters
Embolectomy catheters are used to remove blood clots from arteries or veins. We manufacture single lumen
latex and latex-free embolectomy catheters as well as dual lumen embolectomy catheters. The dual lumen
embolectomy catheter allows clot removal and simultaneous irrigation or guide-wire trackability. We acquired
our LeMaitre Embolectomy Catheter product line and related operations in part from Vermed in June 1999 and in
part from Horizon Medical in March 2001.
Occlusion catheters temporarily occlude blood flow to allow the vascular surgeon time and space to
complete a given procedure. Perfusion catheters temporarily perfuse blood and other liquids into the vasculature.
Our Pruitt Occlusion and Perfusion Catheters reduce vessel trauma by using internal balloon fixation rather than
traditional external clamp fixation. We acquired our Pruitt Occlusion and Perfusion Catheter product lines and
related operations from Horizon Medical in March 2001.
Our embolectomy, occlusion and perfusion catheters are currently sold in the United States, the European
Union, Japan and many other foreign jurisdictions.
General Surgery Products
Reddick Cholangiogram Catheter and Laparoscopic Accessories
The Reddick Cholangiogram Catheter is used to inject dye into the cystic duct during a laparoscopic
cholecystectomy. In this procedure the gall bladder is dissected and removed through small punctures in the
9
abdomen. We also offer two laparoscopic accessories used in laparoscopic gall bladder removal, the Reddick-
Saye Screw and the Grice Suture Needle, which we license from third parties. We acquired the Reddick
Cholangiogram Catheter and laparoscopic accessory product lines and related operations from Horizon Medical
in March 2001.
Our Reddick Cholangiogram Catheter and laparoscopic accessory product lines are currently sold in the
United States, the European Union and many other foreign jurisdictions.
OptiLock Implantable Port
Vascular access ports are implanted into the body and used for central venous administration of
chemotherapy, fluids, nutrients and other therapies as well as for blood sampling for diagnostic purposes. Our
OptiLock Implantable Port is a plastic port with a differentiated connection system design that allows physicians
to securely connect the catheter to the port. We acquired the OptiLock Implantable Port product line and related
operations from Vermed in June 1999.
Our OptiLock Implantable Port product line is currently sold in the United States, the European Union and
many other foreign jurisdictions.
Clinical Studies
We conduct clinical studies in order to obtain regulatory approval and provide marketing data for our
product lines. The goal of a clinical study is to evaluate the safety and/or clinical effectiveness of a device or the
substantial equivalence to another device. We are currently conducting two clinical studies:
• UniFit Abdominal Stent Graft (U.S. Clinical Study). In October 2002, the previous owner of our
UniFit product line commenced a feasibility study in the United States to support a possible PMA
application for the UniFit Abdominal Stent Graft. (See “—Government Regulation” for more on the
PMA process.) We took over this study at the time of our acquisition of Endomed, Inc. in February
2005. In this study, we are seeking to demonstrate successful aneurysm exclusion without perioperative
death, myocardial infarction, stroke, limb loss or surgical conversion. We may enroll up to 60 patients
in this feasibility study and have enrolled 49 patients as of December 31, 2006. A feasibility study is a
preliminary study and is not a pivotal trial, which would be the principal basis for PMA approval. In
May 2006, we submitted an investigational device exemption, or IDE, supplemental application to the
FDA to begin a pivotal clinical trial to evaluate the safety and effectiveness of the UniFit Abdominal
Stent Graft in the treatment of aorto, aorto-iliac and/or iliac aneurysms. In September 2006, we
received conditional approval from the FDA to commence the pivotal trial, which we refer to as the
UNITE study, provided that we resolve the issues identified in the conditional approval letter to the
FDA’s satisfaction. On this basis, we have begun enrollment in the UNITE study. We plan to enroll 90
patients at up to 14 institutions. The primary effectiveness endpoint of the study is based on aneurysm
exclusion as evaluated through one-year follow-up.
• EndoFit Thoracic Stent Graft (Chinese Clinical Study). In August 2005, we commenced a clinical
study to obtain approval from the Chinese State Food and Drug Administration, or SFDA, of our
EndoFit Thoracic Stent Graft. In this study, we are seeking to demonstrate successful aneurysm
exclusion without perioperative death, myocardial infarction, stroke, limb loss or surgical conversion.
We completed enrollment of the planned 30 patients in the study in November 2006. There is a
six-month follow-up period for each patient implanted with the device.
We are also sponsoring a multi-center, non-randomized pilot registry in the European Union, which we refer
to as the DEDICATED registry, to evaluate the use of the EndoFit Thoracic Stent Graft in treating type B aortic
dissections. Certain configurations of our EndoFit Thoracic Stent Graft are already indicated for use in the
treatment of type B dissections. The registry is intended to support an enhanced marketing claim and provide the
10
medical community with safety and efficacy data specific to this particular pathology. We plan to enroll 100
patients and have enrolled 16 patients as of December 31, 2006. There are one-, three- and six-month follow-up
periods after the procedure.
Clinical studies are subject to a number of factors that can influence results, making it difficult to draw
general conclusions. Peripheral vascular studies have historically involved very few patients, with even fewer
patients available for long-term follow up and analysis. Among a small number of treated patients, these factors
can influence the significance of clinical study results. Consequently, findings from one study should not be used
to predict limitations or benefits of a particular means of treatment. We continually evaluate the potential
financial benefits and costs of our clinical studies and the products being evaluated in them. If we determine that
the costs associated with obtaining regulatory approval of a product exceed the potential financial benefits of that
product or if the projected development timeline is inconsistent with our investment horizon, we may choose to
stop a clinical study and/or the development of a product. See “Risk Factors—Our UniFit and EndoFit products
are in clinical studies.” If these clinical studies are unsuccessful, or if the FDA or other regulatory agencies do
not accept or approve the results of such studies, these products may not successfully come to market and our
business prospects may suffer.”
Sales and Marketing
As of December 31, 2006, we employed 47 bag-carrying sales representatives. We believe the expansion of
our direct sales force has been a key factor in our success and it remains one of our primary strategies. We intend
to accelerate the expansion of our sales force. In the United States, for example, we sell directly to hospitals but
do not have sales coverage in several large markets. Outside the United States, we expect to significantly expand
direct sales coverage. Outside our direct markets, we sell our products through a network of country-specific
distributors. We typically sign exclusive distribution agreements with terms of up to three years specifying
minimum annual sales volumes and pricing. These agreements are only renewable by mutual agreement.
We believe that our direct marketing efforts are critical to our brand development and continued success.
Until 1998, we had no direct sales force and instead relied on direct marketing to generate brand awareness and
product loyalty. We believe that our history as a direct marketer of medical devices serves us well today,
allowing us to market to vascular surgeons beyond the reach of our direct sales force.
Research and Development
Our research and development has primarily focused on developing improvements and extensions to our
product lines and improving manufacturing techniques and processes. Our product development efforts are
currently focused on next-generation improvements to our EndoFit and UniFit Stent Grafts, including design
modifications to the stent grafts and to the delivery system, and new products in the endovascular and dialysis
access space.
Our products are subject to our design control validation procedures throughout the various stages of
product development. These procedures may include bench testing, animal testing, human use testing conducted
by independent physicians and post-market surveillance of product performance, as appropriate. We may use
feedback received from independent physicians to demonstrate product functionality, safety and effectiveness
before commencing full-scale marketing of any product.
For fiscal 2004, 2005 and 2006, our research and development expenditures, including our clinical study
expenditures, were $2.1 million, $3.0 million and $3.3 million, respectively, and constituted between 8% and
10% of net sales. As of December 31, 2006, our research and development staff consisted of twelve full-time
engineers and technicians.
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Manufacturing
Our manufacturing facilities are located in Burlington, Massachusetts and include a 5,556 square foot
ISO 14644-1 Class 8 clean room and a 2,100 square foot ISO 14644-1 Class 7 clean room.
As a result of the six acquisitions we executed between 1998 and 2005, we have operated factories in a
variety of locations including France; the United Kingdom; St. Petersburg, Florida; Lawrence, Massachusetts;
and Phoenix, Arizona. All of our manufacturing operations have been relocated to our Burlington, Massachusetts
headquarters in an effort to reduce costs and bring manufacturing closer to our research and development
personnel.
We manufacture certain proprietary components and assemble, inspect, test and package our finished
products. By designing and manufacturing many of our products from raw materials, and assembling and testing
our subassemblies and products, we believe that we can maintain better quality control, ensure compliance with
applicable regulatory standards and our internal specifications, limit outside access to our proprietary technology,
ensure adequate product supply and make design modifications in a timely manner. We have custom-designed
proprietary manufacturing and processing equipment and have developed proprietary enhancements for existing
production machinery.
All of our products are built to stock. In addition, for the year ended December 31, 2006, about 34% of our
EndoFit and UniFit Aortic Stent Grafts were custom-made for specific anatomies as requested by physicians. We
believe our custom manufacturing of stent grafts is a competitive advantage that engenders surgeon loyalty and
brand awareness.
Our management information systems provide us with the ability to evaluate our performance, collect
business intelligence and make better strategic decisions. These systems include order entry, invoicing, on-line
inventory management, lot traceability, purchasing, shop floor control and shipping and distribution analysis, as
well as various accounting-oriented functions. During day-to-day operations, these systems enable us to track our
products from the inception of an order through all parts of the manufacturing process through delivery of the
product to the customer.
We have implemented a variety of manufacturing strategies and techniques with the goal of improving our
gross margin and increasing product quality. By instituting lean manufacturing techniques, also known as
Kaizen, we have been able to eliminate waste in the form of excess time, space and materials from several of our
production lines, while simultaneously improving quality.
We purchase components from third parties. Most of our components are readily available from several
supply sources, but we rely on single and limited source suppliers for several of our key product components. We
do not have contractual arrangements with most of these suppliers, and we order our supplies on an as-needed
basis. To date, we have been able to obtain adequate supplies of all product and components in a timely manner
from existing sources.
Any disruption in our manufacturing capacity could impact our ability to produce sufficient inventory and
meet the demands of our customers, which could adversely affect our financial condition and results of
operations.
Our Burlington facilities have been certified to ISO 13485:2003 quality management system standards,
which enables us to satisfy certain regulatory requirements of the European Union, Canada, and other foreign
jurisdictions. If we were to lose these certifications, we would no longer be able to sell our products in these
countries until we made the necessary corrections to our operations or, in the case of the European Union,
satisfactorily completed an alternate approval route that did not rely on compliance with quality system
standards. Our manufacturing facilities are subject to periodic inspections by regulatory authorities and our
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Notified Body to ensure compliance with domestic and non-U.S. regulatory requirements. See “—Government
Regulation.”
Competition
The markets in which our ten product lines compete are characterized by rapid change resulting from
technological advances and scientific discoveries. No one company competes against us in all of our product
lines. Rather, we compete with a range of companies, from large to small, and including both publicly-traded and
privately held device companies. Notable competitors include C.R. Bard, Inc., Edwards LifeSciences
Corporation, W. L. Gore & Associates, Medtronic, Inc., Cook Group Incorporated, Applied Medical Resources
Corporation, VNUS Medical Technologies, Inc. and Uresil, LLC.
Our products compete primarily on the basis of their unique technology, quality, reliability, ease of use,
cost-effectiveness, physician familiarity, brand recognition and service support. Several of our products are sold
at higher prices than those of our competitors. We believe that our continued success will depend on our ability
to broaden our direct sales channel, acquire or develop additional vascular device product lines, obtain patent or
other product protections, obtain regulatory and reimbursement approvals, maintain sufficient inventory to meet
customer demand, and attract and retain skilled personnel.
Many of our competitors have substantially greater financial, technological, research and development,
regulatory, marketing, sales and personnel resources than we do. Certain of these competitors may also have
greater experience in developing products, obtaining regulatory approvals, and manufacturing and marketing
such products. Certain of these competitors may obtain patent protection or regulatory approval or clearance, or
achieve product commercialization, before us, any of which could materially adversely affect us.
Intellectual Property
We believe that our success is dependent, to a great extent, on the development and maintenance of
proprietary aspects of our technologies. We rely on a combination of patents, trademarks, trade secret laws, and
confidentiality and invention assignment agreements to protect our intellectual property rights.
As of December 31, 2006, we had 88 issued patents and 15 pending patent applications in the United States,
Europe, Japan, Australia, Canada and other countries throughout the world relating to various aspects of our
products and/or manufacturing processes. The majority of our issued U.S. patents are set to expire at various
times from 2012 to 2020. We do not expect the near-term expiration of any of our issued U.S. patents to
adversely affect our intellectual property position.
We intend to file and prosecute patent applications for our technology in jurisdictions where we believe that
patent protection is effective and advisable. Generally, for products that we believe are appropriate for patent
protection, we will attempt to obtain patents in the United States, Japan and key markets of the European Union.
However, depending on circumstances, we may not apply for patents in all or any of those jurisdictions, or we
may pursue patent protection elsewhere.
Notwithstanding the foregoing, the patent positions of medical device companies, including our company, is
uncertain and involves complex and evolving legal and factual questions. The coverage sought in a patent
application can be denied or significantly reduced either before or after the patent is issued. Consequently, there
can be no assurance that any of our pending patent applications will result in an issued patent. There is also no
assurance that any existing or future patent will provide significant protection or commercial advantage, or
whether any existing or future patent will be circumvented by a more basic patent, thus requiring us to obtain a
license to produce and sell the product. Generally, patent applications can be maintained in secrecy for at least 18
months after their earliest priority date. In addition, publication of discoveries in the scientific or patent literature
often lags behind actual discoveries. Therefore, we cannot be certain that we were the first to invent the subject
13
matter covered by each of our pending U.S. patent applications or that we were the first to file non-U.S. patent
applications for such subject matter. In 2005 and 2006, respectively, Boston Scientific Corporation initiated
opposition proceedings in the European Patent Office to oppose our granted European patent number 1,202,682,
or the 682 patent, related to an ePTFE intraluminal device such as certain of our EndoFit and UniFit stent grafts,
and to oppose our granted European patent number 1,148,838, or the 838 patent, related to an ePTFE vascular
prosthesis such as certain of our EndoFit and UniFit stent grafts. Depending on the course of the opposition
proceedings, the granted patent claims in the 682 patent will be amended or may be cancelled while the 838
patent may survive unamended, may be amended, or may be cancelled. We can not assure you that we will be
successful in defending these oppositions.
If a third party files a patent application relating to an invention claimed in our patents or patent
applications, we may be required to participate in an interference proceeding declared by the U.S. Patent and
Trademark Office to determine who owns the patent. Such a proceeding could involve substantial uncertainties
and cost, even if the eventual outcome is favorable to us. There can be no assurance that our patents, if issued,
would be upheld as valid in court.
Third parties may claim that our products infringe on their patents and other intellectual property rights.
Some companies in the medical device industry have used intellectual property infringement litigation to gain a
competitive advantage. If a competitor were to challenge our patents, licenses or other intellectual property
rights, or assert that our products infringe its patent or other intellectual property rights, we could incur
substantial litigation costs, be forced to make expensive changes to our product designs, license rights in order to
continue manufacturing and selling our products, or pay substantial damages. Third-party infringement claims,
regardless of their outcome, would not only consume our financial resources but also divert our management’s
time and effort. Such claims could also cause our customers or potential customers to defer or limit their
purchase or use of the affected products until resolution of the claim.
Certain aspects of our products are the subjects of patents held by third parties. We manufacture, market and
sell these products pursuant to license agreements with these third parties. These arrangements require us to pay
royalties, typically determined as a percentage of our net sales for the underlying product. If we fail to make
these payments or otherwise fail to observe the terms of these agreements, we may lose our ability to sell these
products. For example, we manufacture, market and sell our aortic stent graft products pursuant to a sublicense
from Bard Peripheral Vascular, Inc., a subsidiary of C.R. Bard, Inc., to a U.S. patent covering aspects of ePTFE.
In addition, our arrangement with Bard also precludes us from assigning the agreement to a third party, including
in connection with the sale of 30% or more of our capital stock or all or substantially all of our assets, without the
prior consent of Bard. The loss by us of our right to manufacture, market and sell our aortic stent graft products
could adversely affect our business and results of operations, perhaps materially. We also manufacture, market
and sell our AnastoClip Vessel Closure System pursuant to a license with a third-party patent holder.
We believe that our strong brands have been an important factor in our success. We rely on common law
and registered trademarks to protect our product brands. Some of our registered trademarks are LeMaitre, Pruitt,
EndoFit, VascuTape, Glow ‘N Tell, and Reddick, each of which is registered in the United States and the
European Union, and in certain cases in other foreign countries.
We rely on trade secret protection for certain unpatented aspects of other proprietary technology. There can
be no assurance that others will not independently develop or otherwise acquire substantially equivalent
proprietary information or techniques, that others will not gain access to our proprietary technology or disclose
such technology, or that we can meaningfully protect our trade secrets. We have a policy of requiring key
employees and consultants to execute confidentiality agreements upon the commencement of an employment or
consulting relationship with us. Our confidentiality agreements also require our employees to assign to us all
rights to any inventions made or conceived during their employment with us. We also generally require our
consultants to assign to us any inventions made during the course of their engagement by us. There can be no
14
assurance, however, that these agreements will provide meaningful protection or adequate remedies for us in the
event of unauthorized use, transfer or disclosure of confidential information or inventions.
The laws of foreign countries generally do not protect our proprietary rights to the same extent as do the
laws of the United States. In addition, we may experience more difficulty enforcing our proprietary rights in
certain foreign jurisdictions.
Government Regulation
The products we manufacture and market are subject to regulation by the FDA, and, in some instances,
other federal and state authorities and foreign governments.
United States Regulation
Our products are medical devices subject to extensive regulation by the FDA under the Federal Food, Drug,
and Cosmetic Act, or FDCA. FDA regulations govern, among other things, product development, testing,
manufacture, packaging, labeling, storage, clearance or approval, advertising and promotion, sales and
distribution, and import and export.
Premarket Pathways
Medical devices must receive either 510(k) clearance or premarket application approval, or PMA approval,
from the FDA prior to commercial distribution. Devices deemed to pose relatively less risk are placed in either
class I or II, which requires the manufacturer to submit a premarket notification requesting permission for
commercial distribution; this is known as 510(k) clearance. Some low risk devices are exempted from this
requirement. Class II devices may be subject to special controls such as performance standards and FDA
guidelines that are not applied to class I devices. Devices deemed by the FDA to pose the greatest risk, such as
life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a
previously 510(k) cleared device or to a preamendment class III device (i.e., one in commercial distribution
before May 28, 1976) for which PMA applications have not been called, are placed in class III requiring PMA
approval. In most cases, a user fee is required for 510(k) submissions and PMA applications.
510(k) Clearance. To obtain 510(k) clearance, a manufacturer must submit a premarket notification
demonstrating that the proposed device is substantially equivalent in intended use and in safety and effectiveness
to a “predicate device,” (i.e., a previously 510(k) cleared class I or class II device or a preamendment class III
device for which the FDA has not yet called for PMA applications). The FDA’s 510(k) clearance pathway
usually takes from four to twelve months, but it can last longer. In reviewing a premarket notification, the FDA
may request additional information, including clinical data. All of our devices to date are marketed in the
United States pursuant to the 510(k) process.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or
effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or
could require a PMA approval. The FDA requires each manufacturer to make this determination in the first
instance, but the FDA can review any such decision. If the FDA disagrees with a manufacturer’s decision not to
seek a new 510(k) clearance, the agency may retroactively require the manufacturer to seek 510(k) clearance or
PMA approval. The FDA also can require the manufacturer to cease marketing and/or recall the modified device
until 510(k) clearance or PMA approval is obtained. Also, the manufacturer may be subject to significant
regulatory fines or penalties.
PMA Approval. The PMA approval pathway requires proof of the safety and effectiveness of the device to
the FDA’s satisfaction. The PMA approval pathway is much more costly, lengthy and uncertain. A PMA
application must provide extensive preclinical and clinical trial data and also information about the device and its
15
components regarding, among other things, device design, manufacturing and labeling. As part of the PMA
review, the FDA will typically inspect the manufacturer’s facilities for compliance with the Quality System
Regulation, or QSR, which imposes elaborate testing, control, documentation and other quality assurance
procedures in the manufacturing process.
If the FDA approves a PMA, the approved indications or claims may be more limited than those originally
sought. The PMA can include post-approval conditions that the FDA believes necessary to ensure the safety and
effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and
distribution. Failure to comply with the conditions of approval can result in material adverse enforcement action,
including the loss or withdrawal of the approval. Even after approval of a PMA, a new PMA or PMA supplement
is required in the event of a modification to the device, its labeling or its manufacturing process. Supplements to
a PMA often require the submission of the same type of information required for an original PMA, except that
the supplement is generally limited to that information needed to support the proposed change from the product
covered by the original PMA.
Clinical Trials. A clinical trial is typically required to support a PMA application and is sometimes required
to support 510(k) clearance. In some cases, one or more smaller feasibility IDE studies may precede a pivotal
IDE clinical trial intended to comprehensively demonstrate the safety and effectiveness of the investigational
device. All clinical studies of investigational devices must be conducted in compliance with the FDA’s extensive
requirements. If an investigational device could pose a significant risk to patients (as defined in the regulations),
the FDA, prior to initiation of clinical use, must approve an IDE application showing that it is safe to test the
device in humans and that the testing protocol is scientifically sound. A non-significant risk device does not
require submission to the FDA of an IDE application. Both significant risk and non-significant risk
investigational devices require approval from institutional review boards, or IRBs, at the study centers where the
device will be used. The FDA and the IRB at each institution at which a clinical trial is being performed may
suspend a clinical trial at any time for various reasons, including a belief that the subjects are being exposed to an
unacceptable health risk.
During the study, the sponsor must comply with the FDA’s IDE requirements for investigator selection, trial
monitoring, reporting, record keeping and prohibitions on the promotion of investigational devices. The
investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol,
control the disposition of investigational devices and comply with all reporting and record keeping requirements.
Required records and reports are subject to inspection by the FDA. Prior to granting PMA approval, the FDA
typically inspects the records relating to the conduct of the study and the clinical data supporting the PMA
application for compliance with IDE requirements.
Although the QSR does not fully apply to investigational devices, the requirement for controls on design
and development does apply. The sponsor also must manufacture the investigational device in conformity with
the quality controls described in the IDE application and any conditions of IDE approval that FDA may impose
with respect to manufacturing.
Historically, our products have been introduced into the market using the 510(k) clearance procedure and
we have never used the more burdensome PMA procedure for any of the products that we currently market or
sell in the United States. We expect that the FDA will require both our UniFit Abdominal Stent Graft and
EndoFit Thoracic Stent Graft to undergo the PMA process.
Postmarket Regulation
After a device is placed on the market, regardless of the classification or premarket pathway, significant
regulatory requirements apply. These include:
•
establishment registration and device listing with the FDA;
16
•
•
the QSR, which requires finished device manufacturers, including third-party or contract
manufacturers, to follow stringent design, testing, control, documentation and other quality assurance
procedures during all aspects of manufacturing;
labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved
or off-label uses and other requirements related to promotional activities;
• medical device reporting regulations, which require that manufacturers report to the FDA if their
device may have caused or contributed to a death or serious injury or malfunctioned in a way that
would likely cause or contribute to a death or serious injury if the malfunction were to recur; and
•
corrections and removal reporting regulations, which require that manufacturers report to the FDA any
field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the
device or to remedy a violation of the FDCA that may present a risk to health.
We are subject to inspection and marketing surveillance by the FDA to determine our compliance with
regulatory requirements. Non-compliance with applicable FDA requirements can result in, among other things,
public warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension
of production, failure of the FDA to grant marketing approvals, withdrawal of marketing approvals, a
recommendation by the FDA to disallow us to enter into government contracts, and criminal prosecutions. The
FDA also has the authority to request repair, replacement or refund of the cost of any device manufactured or
distributed by us. In the event that one of our suppliers fails to maintain compliance with our quality
requirements, we may have to qualify a new supplier and could experience manufacturing delays as a result.
In March 2006, the FDA inspected our facilities in Burlington, Massachusetts for three days. The inspection
resulted in the issuance of a formal notification, or Form FDA-483, listing three observations. Specifically, the
FDA observed that we did not adequately document corrective and preventive actions taken by us to address
quality problems, we did not identify all actions needed to prevent the recurrence of nonconforming product and
other quality problems, and we had an incomplete procedure for implementing and recording actions taken to
correct and prevent identified quality problems. While we have revised our procedures and conducted additional
training to address the FDA’s findings, we cannot assure you that we have been successful in implementing these
changes or that the FDA will agree that our implementation is adequate. If the FDA finds that we are not in
substantial compliance with the QSR, the FDA may issue a public warning letter or take other enforcement
action against us and our operations could be disrupted and our manufacturing delayed.
Non-U.S. sales of medical devices manufactured in the United States that are not approved or cleared by the
FDA for use in the United States, or are banned or deviate from lawful performance standards, are subject to
FDA export requirements. Before exporting such products to a foreign country, we must first comply with the
FDA’s regulatory procedures for exporting unapproved devices.
Other U.S. Regulations
We and our products are also subject to a variety of state and local laws in those jurisdictions where our
products are or will be marketed, and federal, state and local laws relating to matters such as safe working
conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or
potentially hazardous substances. We are subject to various federal and state laws governing our relationships
with the physicians and others who purchase or make referrals for our products. For instance, federal law
prohibits payments of any form that are intended to induce a referral for any item payable under Medicare,
Medicaid or any other federal healthcare program. Many states have similar laws. There can be no assurance that
we will not be required to incur significant costs to comply with such laws and regulations now or in the future or
that such laws or regulations will not have a material adverse effect upon our ability to do business.
We are subject to federal, state and local laws, rules, regulations and policies governing the use, generation,
manufacture, storage, air emission, effluent discharge, handling and disposal of certain hazardous and potentially
17
hazardous substances used in connection with our operations. Although we believe that we have complied with
these laws and regulations in all material respects and to date have not been required to take any action to correct
any noncompliance, there can be no assurance that we will not be required to incur significant costs to comply
with environmental regulations in the future.
Non-U.S. Regulation
Sales of medical devices are subject to regulatory requirements in many countries. The regulatory review
process may vary greatly from country to country. For example, the European Union has adopted numerous
directives and standards relating to medical devices regulating their design, manufacture, clinical trials, labeling
and adverse event reporting, including the Medical Devices Directive (93/42/EEC), which is applicable to our
products. Devices that comply with the requirements of the Medical Devices Directive are entitled to bear a
Conformité Européenne, or CE mark, indicating that the device conforms with the essential requirements of the
applicable directive and can be commercially distributed in countries that are members of the European Union, as
well as Iceland, Lichtenstein, Norway and Switzerland. The member states of the European Union have
implemented the directives into their respective national law, and have each established a “Competent Authority”
to apply the directive in its territory.
The Directive defines a classification system placing devices into Class I, IIa, IIb or III, depending on the
risks and characteristics of the medical device. The Directive also defines the essential requirements that devices
must meet before being placed on the market, establishes assessment procedures for approving a device for
marketing and creates mechanisms for national authorities to manage implementation or to intervene when public
health requires. Essential requirements include manufacturing, design, performance, labeling and safety
requirements, and may include providing certain clinical data. These requirements vary based on the type of the
device and other related factors.
A manufacturer of low risk devices typically may demonstrate conformity to the essential requirements
based on a self-declaration. The European Standardization Committees have adopted numerous harmonized
standards for specific types of medical devices. Compliance with relevant standards establishes a presumption of
conformity with the essential requirements. Higher risk devices generally must use a “Notified Body”—an
appointed independent third party to assess conformity. This third-party assessment may consist of an audit of
the manufacturer’s quality system and specific testing of the manufacturer’s devices. An assessment by a
Notified Body in one country within the European Union is generally required in order for a manufacturer to
commercially distribute the product throughout the European Union. Most of our devices are considered higher
risk devices that require Notified Body assessment.
The European medical device laws also address the advertising and promotion of medical devices, clinical
investigations and requirements for handling adverse events. Post-market surveillance of medical devices in the
European Union is generally conducted on a country-by-country basis; however, the Directive sets forth certain
specific requirements for reporting adverse events. The Medical Device Vigilance system is the mechanism by
which adverse event reporting is managed and monitored in the European Union.
In some cases, we rely on our non-U.S. distributors to obtain premarket approvals, complete product
registrations, comply with clinical trial requirements and complete those steps that are customarily taken in the
applicable jurisdictions in connection in those countries to comply with governmental and quasi-governmental
regulation. In the future, we expect to continue to rely on distributors in this manner in those countries where we
continue to market and sell our products through them.
In Japan, the Ministry of Health, Labor and Welfare, or MHLW, regulates medical devices through the
Pharmaceutical Affairs Law, or PAL, which was reformed effective April 1, 2005. Implementation and
enforcement of the reforms are evolving, and compliance guidance from the MHLW is still in development. The
revisions to Japan regulations have resulted in longer lead times for product development.
There can be no assurance that new laws or regulations or new interpretations of laws and regulations
regarding the release or sale of medical devices will not delay or prevent sale of our current or future products.
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Third-Party Reimbursement
United States
Healthcare providers that purchase medical devices generally rely on third-party payors, including the
Medicare and Medicaid programs and private payors, such as indemnity insurers, employer group health
insurance programs and managed care plans, to reimburse all or part of the cost of the products. As a result,
demand for our products is and will continue to be dependent in part on the coverage and reimbursement policies
of these payors. The manner in which reimbursement is sought and obtained varies based upon the type of payor
involved and the setting in which the product is furnished and utilized. Furthermore, payments from Medicare,
Medicaid and other third-party payors are subject to legislative and regulatory changes and are susceptible to
budgetary pressures.
In the United States, third-party payors generally pay healthcare providers directly for the procedures they
perform and in certain instances for the products they use. However, in many cases, third-party payors operate by
reimbursing patients for all or part of the charges that patients pay for procedures and products used in
connection with those procedures. In either case, our sales volumes depend on the extent to which third-party
payors cover our products and the procedures in which they are used. In general, a third-party payor only covers
a medical product or procedure when the plan administrator is satisfied that the product or procedure is medically
necessary by improving health outcomes, including quality of life or functional ability, in a safe and cost-
effective manner. Even if a device has received clearance or approval for marketing by the FDA, there is no
assurance that third-party payors will cover the cost of the device and related procedures in which the device is
used.
In many instances, third-party payors cover the procedures performed using our products using price fee
schedules that do not vary reimbursement to reflect the cost of the products and equipment used in performing
those procedures. In other instances, payment or reimbursement is separately available for the products and
equipment used, in addition to payment or reimbursement for the procedure itself. Even if coverage is available,
third-party payors may place restrictions on the circumstances where they provide coverage or may offer
reimbursement that is not sufficient to cover the cost of our products. Many of the products that compete with
ours are less expensive. Therefore, although coverage may be available for our products and the related
procedures, the levels of approved coverage may not be sufficient to justify using our products instead of those of
competitors.
Third-party payors are increasingly challenging the prices charged for medical products and procedures and,
where a reimbursement model is used, introducing maximum reimbursements for the procedures they cover. We
believe that the minimally invasive procedures in which our products are used are generally less costly than open
surgery because they frequently result in shorter hospitalization times. However, there is no guarantee that these
procedures will be reimbursed. Third-party payors may not consider these minimally invasive procedures to be
cost-effective and therefore refuse to authorize coverage.
Finally, the advent of contracted fixed rates per procedure has made it difficult to receive separate
reimbursement for disposable products, even if the use of these products improves clinical outcomes. In addition,
many third-party payors are moving to managed care systems in which providers contract to provide
comprehensive healthcare for a fixed cost per person. Managed care providers often attempt to control the cost of
healthcare by authorizing fewer elective surgical procedures. Under current prospective payment systems, such
as the diagnosis related group system and the hospital out-patient prospective payment system, both of which are
used by Medicare and in many managed care systems used by private third party payors, the reimbursement for
our products will be incorporated into the overall reimbursement of a procedure and there will be no separate
reimbursement for our products. As a result, we cannot be certain that hospital administrators and physicians will
purchase our products.
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If hospitals and physicians cannot obtain adequate reimbursement for our products or the procedures in
which they are used, our business, financial condition and results of operations could suffer a material adverse
impact.
Non-U.S.
Our success in non-U.S. markets will depend largely upon the availability of reimbursement from the third-
party payors through which healthcare providers are paid in those markets. Reimbursement and healthcare
payment systems in non-U.S. markets vary significantly by country. The main types of healthcare payment
systems are government sponsored healthcare and private insurance. Reimbursement approval must be obtained
individually in each country in which our products are marketed. Outside the United States, we generally rely on
the distributors who sell our products to obtain reimbursement approval for those countries in which they will
sell our products. There can be no assurance that reimbursement approval will be received.
Fraud and Abuse Laws
We may directly or indirectly be subject to various federal and state laws pertaining to healthcare fraud and
abuse, including anti-kickback laws. In particular, the federal healthcare program Anti-Kickback Statute
prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly
or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing, arranging for or
recommending a good or service, for which payment may be made in whole or part under federal healthcare
programs, such as the Medicare and Medicaid programs. Penalties for violations include criminal penalties and
civil sanctions such as fines, imprisonment and possible exclusion from Medicare, Medicaid and other federal
healthcare programs. The Anti-Kickback Statute is broad and prohibits many arrangements and practices that are
lawful in businesses outside of the healthcare industry. In implementing the statute, the Office of Inspector
General, or OIG, has issued a series of regulations, known as the “safe harbors.” These safe harbors set forth
provisions that, if all their applicable requirements are met, will assure healthcare providers and other parties that
they will not be prosecuted under the Anti-Kickback Statute. The failure of a transaction or arrangement to fit
precisely within one or more safe harbors does not necessarily mean that it is illegal or that prosecution will be
pursued. However, conduct and business arrangements that do not fully satisfy each applicable element of a safe
harbor may result in increased scrutiny by government enforcement authorities, such as the OIG.
Employees
We had 218 full time employees at December 31, 2006. Of these employees, 106 were in manufacturing and
research and development, 77 were in sales and marketing, 10 were in clinical, regulatory and quality assurance
and 25 were in general and administrative. We have never had a work stoppage and none of our employees is
covered by a collective bargaining agreement. We believe our employee relations are good.
Backlog
We have not typically maintained a significant backlog. As a result, we do not believe that our backlog at
any particular date is necessarily an accurate predictor of revenue for any succeeding period.
Customers
Our sales are not dependent on any single customer or distributor, and we continue to expand our
distribution channel worldwide through direct and indirect sales forces. We experience some seasonal reduction
of our product sales in our third fiscal quarter due to the summer holiday schedule of physicians and their
patients.
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Item 1A. Risk Factors
The following important factors, among others, could cause our actual operating results to differ materially
from those indicated or suggested by forward-looking statements made in this Form 10-K or presented elsewhere
by management from time to time.
Risks Related to Our Business
We do not expect to achieve profitability in the near term, especially as we expand our direct sales force,
conduct our clinical studies and acquire and develop new product offerings, businesses or technologies.
We expect to make substantial expenditures to expand our direct sales force, conduct our clinical studies
and acquire and develop new product offerings, businesses or technologies. As a result, we do not expect to be
profitable in the near term, and we will need to generate significant net sales in future periods to achieve and
maintain profitability. Our ability to achieve and maintain profitability will be influenced by many factors,
including:
•
the level and timing of future sales and expenditures;
• market acceptance of our new products;
•
•
•
•
•
•
the productivity of our direct sales force and distributors;
the cost of our clinical studies;
our ability to successfully acquire and develop competitive products;
our ability to successfully integrate acquired businesses, products or technologies;
the impact on our business of competing products, technologies and procedures;
our ability to obtain regulatory approvals for our products in new markets;
• market and regulatory developments; and
•
the cost of intellectual property challenges, if any.
We cannot assure you that we will achieve significant net sales or achieve and maintain profitability.
Our results of operations are substantially dependent on businesses and assets that we acquired from third
parties, and if we experience difficulties in completing the integration of these acquisitions into our business,
or if we do not realize the anticipated benefits of these acquisitions, then our financial condition and results of
operations could be adversely affected.
Since 1998 we have completed six acquisitions. Our operating results are largely dependent on these
acquired product lines, and this dependence exposes us to risks and uncertainties.
For example, we have only recently completed the relocation of the manufacturing operations related to our
EndoFit Thoracic Stent Graft and UniFit Abdominal Stent Graft, which we acquired from Endomed, Inc. in
February 2005. We now manufacture this product line solely in our Burlington, Massachusetts headquarters. Due
to our limited experience with manufacturing the device ourselves, we may encounter difficulties or delays that
could negatively impact product quality or impair our ability to manufacture sufficient quantities to satisfy
demand, either of which in turn could have a material adverse effect on our financial condition or results of
operations.
We also may experience other difficulties related to these acquisitions. For example, in connection with our
Endomed acquisition, we acquired an ongoing clinical study related to the UniFit Abdominal Stent Graft. See
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“Business—Clinical Studies.” Our experience in conducting clinical studies is limited and we may experience
difficulties or delays in transitioning this study or future studies. Also, we may determine that the design of this
acquired study does not meet our business objectives. Any difficulties or delays we experience in connection
with this clinical study could negatively impact our ability to obtain regulatory approval to market the UniFit
Abdominal Stent Graft in certain markets. In addition, the products that we have acquired may need to be
improved in order to gain broader market acceptance or may not compete effectively with existing products. We
have limited experience with certain technologies underlying the acquired products. There can be no assurance
that we will be successful developing the desired product improvements in a timely manner, if at all.
In April 2003, we acquired the Expedial Vascular Access Graft product line from Credent Limited, a UK
company. At the time of the acquisition, the Expedial Vascular Access Graft had already received a Conformité
Européenne, or CE mark, and was being sold in the European Union and other foreign jurisdictions. In May
2004, we commenced a clinical study in the United States to collect data to submit to the FDA in support of
510(k) clearance for this device. In July 2006, we received preliminary data from the clinical study conducted for
the period from April 8, 2004 to June 28, 2006 suggesting that the device may not compare favorably to ePTFE
grafts. There were no significant safety issues identified in the preliminary data collected in the clinical study. As
a result of our review of the clinical study results and less than planned sales of the product in Europe, we
decided to forego further enrollment in the clinical study and cease the production and sale of this device. In
October 2006, we sold certain manufacturing equipment, inventory and intellectual property related to our
Expedial Vascular Access Graft product line to CardioTech International, Inc. for total consideration of $350,000
plus a five percent royalty on CardioTech’s net sales of its CardioPass brand coronary artery bypass graft for a
period of five years following the first commercial sale of a CardioPass graft. Clinical trials on the CardioPass
graft have only recently been initiated and there can be no assurance that it will ever be commercialized.
Any of these difficulties could negatively impact our ability to realize the intended and anticipated benefits
that we currently expect from our acquisitions and could have a material adverse effect on our financial condition
and results of operations.
If we are unable to expand our product offerings, we may not achieve our growth objectives and our results of
operations could suffer.
We may not be able to compete effectively with our competitors unless we can keep pace with existing or
new products and technologies in the vascular device market. Our success in developing and commercializing
new products and new versions of our existing products is affected by our ability to:
•
•
•
•
•
•
identify in a timely manner new market trends and customer needs;
keep pace with technological changes and industry standards;
obtain regulatory clearance or approval of new products and technologies;
successfully develop cost-effective manufacturing processes for such products;
commercially introduce such products and technologies; and
achieve market acceptance.
If we are unable to expand our product offerings, we may not achieve our growth objectives and our results
of operations could suffer.
Our results of operations could be negatively affected if we are unable to complete and integrate suitable
acquisitions.
In order to expand our product offerings, we have acquired six businesses since 1998, and a key part of our
strategy is to acquire additional businesses, products or technologies in the future. Our growth strategy depends
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in part upon our ability to identify, negotiate, complete and integrate suitable acquisitions. If we are unable to
complete acquisitions on satisfactory terms, our growth objectives could be negatively affected.
Even if we complete acquisitions, we may experience:
•
•
•
•
•
•
•
•
•
difficulties in integrating any acquired companies, personnel and products into our existing business;
difficulties in integrating manufacturing operations into our existing business or successfully
replicating manufacturing processes at new manufacturing facilities;
difficulties or delays in transitioning clinical studies or unfavorable results from such clinical studies;
diversion of our management’s time and attention from other business concerns;
challenges resulting from limited or no direct prior experience in new markets or countries we may
enter;
higher costs of integration than we anticipated;
difficulties in retaining key employees of the acquired business who are necessary to manage these
acquisitions;
difficulties in acquiring the right to and protecting intellectual property; or
difficulties if the acquired company is remote or inconvenient to our Burlington, Massachusetts
headquarters.
For any of these reasons or as a result of other factors we may not realize the anticipated benefits of
acquisitions.
If we fail to convert additional countries from distributor sales to direct sales, our results of operations could
suffer.
We intend to convert selected countries from distributor sales to direct sales, which could result in
disruptions in our sales. This transition may also have an adverse effect on our cash flow from operations
because distributors, unlike direct sales personnel, pay us for inventory that they stock for later sale. In addition,
switching to a direct sales force may subject us to longer customer collection times and larger bad debt expense
since we would be required to collect customer payments directly rather than through a distributor. Also, our
distribution agreements are typically exclusive with terms of up to three years. These agreements may
temporarily constrain our ability to convert certain countries from a distributor to a direct sales model. As a
result, there can be no assurance that we will be successful in transitioning to a direct sales model in the countries
that we select, and difficulties that we encounter in this transition could negatively affect our business.
Existing or future acquisitions of new products or businesses could negatively affect our results of operations
if we do not discover previously undisclosed liabilities.
In a future acquisition we could discover deficiencies withheld from us due to fraud or otherwise not
uncovered in our due diligence prior to the acquisition, including deficiencies in internal controls, data adequacy
and integrity, product quality and regulatory compliance, as well as undisclosed and product liabilities, any of
which could result in us becoming subject to penalties or other liabilities. Any such undisclosed liabilities could
have an adverse effect on our financial condition and results of operations.
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Some of our devices have been recently introduced into the market and may not achieve market acceptance,
which could adversely affect our business.
Some of our devices have been recently introduced into the market, and we cannot assure you that they will
achieve market acceptance. The same is true of new devices that we may acquire or internally develop in the
future. The marketing of our products requires a significant amount of time and expense in order to identify and
develop relationships with the physicians who may use our products, invest in training and education with these
physicians and employ a sales force that is large enough to interact with the targeted physicians, with no
assurance of success. In some cases, our devices may face competition from devices marketed by our
competitors, and our customers may not prefer our device. In other cases, our devices may be used in new
procedures and techniques and if physicians do not adopt these procedures and techniques, demand for these
devices would fail to develop. For example, in 2004 we launched our InvisiGrip Vein Stripper, which has not
achieved widespread market adoption because of competing products and techniques. If our products do not gain
market acceptance, our business could be adversely affected.
If we are unable to manage the anticipated growth of our business, our financial condition and operating
results could be adversely affected.
The growth that we have experienced, and may experience in the future, will continue to provide challenges
to our organization. For example, since 1998 we have completed six acquisitions and we expect to pursue
additional acquisitions in the future. As our operations expand, both in terms of scope and geographic coverage,
we expect that we will need to manage additional relationships with various partners, suppliers and other
organizations. We also will need to manage the corresponding growth of our manufacturing operations. Our
ability to manage our operations and growth requires us to continue to improve our operational, financial and
management controls and reporting systems and procedures, and may require us to transition to new enterprise
management software. Such growth could place a strain on our administrative and operational infrastructure. We
may not be able to make improvements to our management information and control systems in an efficient or
timely manner, and we may discover deficiencies in existing systems and controls. If we cannot scale and
manage our business appropriately, our anticipated growth may be impaired and our financial results could
suffer.
We depend on single and limited source suppliers for some of the components to our products, and if any of
those suppliers are unable or unwilling to supply them on acceptable terms, it could limit our ability to deliver
our products to our customers on a timely basis or at all.
We rely on single and limited source suppliers for some of our important product components. For example,
we obtain from a third party supplier all of the nitinol stents used in and from another third-party supplier all of
the stent graft delivery systems that are used with our EndoFit Thoracic Stent Graft and UniFit Abdominal Stent
Graft. There are relatively few, or in some cases no, alternative, validated sources of supply for these
components. We do not have supply agreements with most of these suppliers, and instead place orders on an
as-needed basis. Most of these suppliers could discontinue the manufacture or supply of these components at any
time. We do not carry a significant inventory of these components. Identifying and qualifying additional or
replacement suppliers for any of these components, if required, may not be accomplished quickly or at all and
could involve significant additional costs. Any supply interruption from our vendors or failure to obtain
additional vendors for any of the components used to manufacture our products would limit our ability to
manufacture our products, may result in production delays and increased costs and may limit our ability to
deliver products to our customers. If we are unable to identify alternate sources of supply for the components, we
would have to modify our products to use substitute components, which may cause delays in shipments, increase
design and manufacturing costs and increase prices for our products. We can not assure you that any such
modified products would be as effective as the predecessor products, or that such modified products would gain
market acceptance. This could lead to customer dissatisfaction and damage to our reputation and could have an
adverse effect on our financial condition and results of operations.
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Any disruption in our manufacturing facilities could adversely affect our business and results of operations.
Our principal worldwide executive, distribution and manufacturing operations are located at a 27,098 square
foot leased facility and a nearby 7,477 square foot leased facility, located in Burlington, Massachusetts. These
facilities and the manufacturing equipment we use to produce our products would be difficult to replace and
could require substantial lead-time to repair or replace in the event of a natural or man-made disaster. In such
event, we could not shift production to alternate manufacturing facilities and we would be forced to rely on third-
party manufacturers. Although we possess insurance for damage to our property and the disruption of our
business from casualties, such insurance may not be sufficient to cover all of our potential losses, including
potential damage to our reputation, and may not continue to be available to us on acceptable terms, or at all. In
addition, our growth may outpace our manufacturing capacity, in which event we would need to locate, obtain
and build-out additional space. New or alternative facilities may not be available to us on acceptable terms. Even
if we are able to identify such new or alternative facilities, we may incur additional costs and we may experience
a disruption in the supply of our products until those facilities are available. Our leases for our Burlington,
Massachusetts manufacturing facilities expire in 2008 and we may not be able to renew these leases on terms
acceptable to us or at all. Any disruption in our manufacturing capacity could have an adverse impact on our
ability to produce sufficient inventory to meet the demands of our customers, which could have an adverse effect
on our financial condition and results of operations.
We depend on our senior management team and other key scientific, sales and technical personnel, and if we
are unable to retain them or recruit additional qualified personnel we may not be able to manage our
operations and meet our strategic objectives, which could have an adverse effect on our financial condition
and results of operations.
We depend on the continued services of our senior management team and other key scientific, sales and
technical personnel, as well as our ability to continue to attract and retain additional highly qualified personnel.
Our ability to retain our skilled labor force and our success in attracting and hiring new skilled employees will be
a critical factor in determining whether we will be successful in the future. Each of our key employees may
terminate their employment with us at any time. The loss of any of our senior management team or key
employees could harm our business. We compete for such personnel with other companies, academic
institutions, government entities and other organizations. We may not be able to meet our future hiring needs or
retain existing personnel on acceptable terms. We could face significant challenges and risks in hiring, training,
managing and retaining engineering and sales employees. Any loss or interruption of the services of our other
key personnel could also significantly reduce our ability to effectively manage our operations and meet our
strategic objectives because we cannot assure you that we would be able to find an appropriate replacement
should the need arise. We maintain life insurance payable to us on our Chairman, President and Chief Executive
Officer, George W. LeMaitre, but not on our other key personnel.
If we do not maintain our relationships with our physician customers, our growth may be limited and our
business could be harmed.
Physicians typically influence the medical device purchasing decisions of the hospitals and other healthcare
institutions in which they practice. Consequently, our relationships with our physician customers are critical to
our continued growth. We believe that these relationships are based on our long-standing reputation and presence
in the market for peripheral vascular devices, the quality of our product offerings and clinical outcomes, our
marketing efforts and our presence at medical society meetings. Any actual or perceived diminution in our
reputation or the quality of our products or our failure or inability to maintain these other efforts could damage
our current relationships, or prevent us from forming new relationships, with physicians and cause our growth to
be limited and our business to be harmed.
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Our primary focus on the needs of vascular surgeons could harm our business if interventional cardiologists
and interventional radiologists perform a greater percentage of new procedures that replace those procedures
traditionally performed by vascular surgeons, or if vascular surgeons increasingly specialize in procedures for
which we do not sell devices.
The treatment of peripheral vascular disease is increasingly shifting from open vascular surgery to
minimally invasive endovascular procedures. We market and sell our products primarily to vascular surgeons,
who in addition to performing traditional open surgical procedures, in growing numbers also perform minimally
invasive, image-guided interventional procedures for peripheral vascular disease. However, vascular surgeons
may not adopt these procedures in the numbers we expect and instead these procedures may be largely performed
by interventional cardiologists and interventional radiologists. Many of our competitors have focused their sales
efforts on these interventionalists. If interventional radiologists and interventional cardiologists perform an
increasing percentage of these new procedures than we expect, our net sales may decline and our business may
be affected.
Moreover, demographic trends and other market factors, such as reimbursement rates, are driving vascular
surgeons in the United States and potentially in other markets to increasingly specialize in certain kinds of
procedures, such as endovascular therapies, the creation and maintenance of dialysis access sites and the
treatment of varicose veins. Sometimes these physicians will discontinue performing other vascular procedures.
If this trend continues, it could lead to the fragmentation of our customer base, which would reduce cross-selling
opportunities and the efficiency of each sales call by our sales representatives, which in turn would negatively
impact our business.
We face competition from other companies, technologies and alternative medical procedures, all of which
could adversely impact our business, net sales and results of operations. Consolidation in the medical
technology industry could exacerbate these risks.
The markets in which we compete are highly competitive, subject to change and significantly affected by
new product introductions and other activities of industry participants. Although no one company competes
against us in all of our product lines, a number of manufacturers of peripheral vascular devices have substantially
greater capital resources, larger customer bases, broader product lines, larger sales forces, greater marketing and
management resources, larger research and development staffs and larger facilities than ours, have established
reputations with our target customers and have developed worldwide distribution channels that are more effective
than ours. Our competitors could elect to devote additional resources to the markets in which we currently enjoy
less competition. Also, although we currently have leading market positions in the markets for some of our
products, this is not true for the markets for all of our products, in particular our endovascular and dialysis access
products. Recent industry consolidation could make the competitive environment more difficult for smaller
companies like ours. Because of the size of the vascular disease market opportunity, competitors and potential
competitors have dedicated, and we believe will continue to dedicate, significant resources to aggressively
promote their products. Also, new product developments that could compete with us more effectively are likely
because the vascular disease market is characterized by extensive research efforts and technological progress.
Competitors may develop technologies and products that are safer, more effective, and easier to use, less
expensive or more readily accepted than ours. Their products could make our technology and products obsolete
or noncompetitive. Our competitors may also be able to achieve more efficient manufacturing and distribution
operations than we can and may offer lower prices than we could offer profitably. In addition, many of our
products face competition from alternative procedures that utilize a different kind of medical device that we do
not currently sell. Any of these competitive factors could adversely impact our business, net sales and results of
operations.
If there is a disruption in the supply of products from Endologix, Inc. that we distribute or if our relationship
with Endologix is impaired, our net sales and results of operations could be adversely impacted.
We have entered into a three-year agreement with Endologix, Inc., to distribute the Powerlink System in ten
European countries, including Germany, France and the United Kingdom. Our success in marketing the
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Powerlink System is dependent on our sales personnel being proficient in the product line, building physician
relationships and executing sales orders. If we are unable to market the Powerlink System successfully or if our
agreement with Endologix is terminated, our net sales and results of operations could suffer. If we do not meet
our performance requirements under the agreement, the agreement may be terminated by Endologix. In addition,
even if we market the Powerlink System successfully, if Endologix is unable to produce enough of its products to
meet our demands, we may not be able to meet our customers’ demands and our net sales and results of
operations may suffer. This distribution relationship also exposes us to the risk that the distribution of the
Powerlink System disproportionately absorbs company resources that would otherwise be dedicated to other
projects and the risk that the European market does not rapidly adopt the Powerlink System, in either of which
cases our net sales and results of operations may suffer.
Our lack of customer purchase contracts makes it difficult to predict sales and plan manufacturing
requirements, which could lead to lower net sales, higher expenses and reduced margins.
We do not have long-term purchase contracts with our hospital customers, who typically order products on
an as-needed basis. As a result, it is difficult to accurately forecast our component and product requirements. Our
manufacturing and operating expenses are largely based on anticipated sales volume and a significant portion of
these expenses is and will continue to be fixed. We must plan production and order product components several
months in advance of customer orders. In addition, lead times for product components that we order vary
significantly and depend on factors such as the specific supplier and demand for each component at any given
time. These factors expose us to a number of risks, such as the following:
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if we overestimate our requirements, or experience shortages, we may be obligated to carry more
inventory than we need;
if we underestimate our requirements, we may have an insufficient product component inventory,
which could disrupt manufacturing of our products and cause delays in shipments and net sales; and
if we experience shortages of product components from time to time, which could delay the
manufacturing and shipping of our products.
If any of the foregoing occurs, it could lead to lower net sales, higher expenses and reduced margins.
Our business strategy relies on assumptions about the market for our products, which, if incorrect, could
adversely affect our business prospects and profitability.
We are focused on the market for devices used to treat peripheral vascular disease. We believe that
demographic trends point towards an increase in the need for our products. However, the projected demand for
our products could materially differ from actual demand if our assumptions regarding these trends and
acceptance of our products by the medical community prove to be incorrect or do not materialize or if drug
therapies gain more widespread acceptance as a viable alternative treatment, which in each case could adversely
affect our business prospects and profitability.
The use, misuse or off-label use of our products may result in injuries that lead to product liability suits,
which could be costly to our business.
Although we offer training for physicians in the use of some of our products, we do not require that
physicians be trained in the use of our products. Not requiring training specific to the use of our devices may
expose us to greater risk of product liability if injuries occur during a procedure involving our products. In
addition, if demand for our products continues to grow, less skilled surgeons will likely use the devices,
potentially leading to an increased incidence of patient injury and an increased risk of product liability. The
off-label use of our products may result in an increased risk of serious injuries or death.
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As is the case with other medical device companies, product liability claims could be brought against us. If
our products are defectively designed, manufactured or labeled, contain defective components or are misused, or
if our products are found to have caused or contributed to injuries or death, we may become subject to costly
litigation by our customers or their patients. Product liability claims could divert management’s attention from
our core business, be expensive to defend and result in sizable damage awards against us. Claims of this nature
may also adversely affect our reputation, which could damage our position in the market and subject us to
product recalls.
We cannot assure you that our product liability insurance coverage will be sufficient to satisfy any claim
made against us. Further, we may not be able to maintain the same level of coverage, and we may not be able to
obtain adequate coverage at a reasonable cost and on reasonable terms, if at all. Any product liability claim
brought against us, with or without merit, could increase our product liability insurance rates or prevent us from
securing coverage in the future. Additionally, if any such product liability claim or series of claims is brought
against us for uninsured liabilities or is in excess of our insurance coverage, our business could be harmed.
The risks inherent in operating internationally and the risks of selling and shipping our products and of
purchasing our components and products internationally may adversely impact our net sales, results of
operations and financial condition.
We derive a significant portion of our net sales from operations in markets outside of the United States and
Canada. For the year ended December 31, 2006, 35% of our net sales were derived from our operations outside
of the United States and Canada. Our international sales operations expose us and our representatives, agents and
distributors to risks inherent in operating in foreign jurisdictions. These risks include:
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the imposition of additional U.S. and foreign governmental controls or regulations, including export
licensing requirements, duties and tariffs and other trade restrictions;
the risk of non-compliance with the Foreign Corrupt Practices Act by our sales representatives or our
distributors;
the imposition of U.S. and/or international sanctions against a country, company, person or entity with
whom the company does business that would restrict or prohibit continued business with the sanctioned
country, company, person or entity;
a shortage of high-quality sales people and distributors;
loss of any key personnel who possess proprietary knowledge, or who are otherwise important to our
success in certain international markets;
changes in third-party reimbursement policies that may require some of the patients who receive our
products to directly absorb medical costs or that may necessitate the reduction of the selling prices of
our products;
the imposition of restrictions on the activities of foreign agents, representatives and distributors;
scrutiny of foreign tax authorities, which could result in significant fines, penalties and additional taxes
being imposed on us;
pricing pressure that we may experience internationally;
laws and business practices favoring local companies;
longer payment cycles;
difficulties in enforcing agreements and collecting receivables through certain foreign legal systems;
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difficulties in enforcing or defending intellectual property rights;
exposure to different legal and political standards; and
political, economic and/or social instability.
We cannot assure you that one or more of these factors will not harm our business. Any material decrease in
our international sales would adversely impact our net sales, results of operations and financial condition.
Any operations that we conduct in China will expose us to the risk of adverse changes in political, legal and
economic policies of the Chinese government, which changes could reduce the demand for our products in
China and materially and adversely affect our competitive position in China.
Although we currently do not market any of our products in China, we are currently conducting a clinical
study to obtain approval from the Chinese State Food and Drug Administration to market our EndoFit Thoracic
Stent Graft in China. If and when this product is approved for sale in China, we expect to initially market our
device using one or more distributors. Conducting business in China, if we seek to enter that market, would
expose us to a variety of risks and uncertainties that are unique to China. The Chinese economy differs from the
economies of most developed countries in many respects, including:
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level of government involvement;
economic structure;
allocation of resources;
level of development;
inflation rates;
growth rate; and
control of foreign exchange.
The economy of China has been transitioning from a planned economy to a more market-oriented economy.
Although in recent years the Chinese government has implemented measures emphasizing the utilization of
market forces for economic reform, the reduction of state ownership of productive assets and the establishment
of sound corporate governance in business enterprises, a substantial portion of productive assets in China is still
owned by the Chinese government. In addition, the Chinese government continues to play a significant role in
regulating industrial development. It also exercises significant control over China’s economic growth through the
allocation of resources, controlling payment of foreign currency-denominated obligations, setting monetary
policy and providing preferential treatment to particular industries or companies. Efforts by the Chinese
government to slow the pace of growth of the Chinese economy could result in decreased capital expenditure by
hospitals, which in turn could reduce demand for our products. In addition, the Chinese legal system is a civil law
system based on written statutes. Unlike common law systems, it is a system in which decided legal cases have
little precedential value. In 1979, the Chinese government began to promulgate a comprehensive system of laws
and regulations governing economic matters in general. Accordingly, we cannot predict the effect of future
developments in the Chinese legal system, including the promulgation of new laws, changes to existing laws or
the interpretation or enforcement thereof, or the preemption of local regulations by national laws.
Fluctuations in foreign currency exchange rates could result in declines in our reported sales and earnings.
Because the majority of our sales outside of the United States are denominated in local currencies, our
reported sales and earnings are subject to fluctuations in foreign exchange rates. We cannot predict the impact of
foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our sales and
earnings. At present, we do not manufacture our products outside the United States nor do we engage in hedging
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transactions to protect against uncertainty in future exchange rates between particular foreign currencies and the
U.S. dollar.
We rely on our independent distributors to market and sell our products in select markets outside of the
United States and Canada.
Sales of our products through independent distributors represented 13% of our net sales for the year ended
December 31, 2006. Our success in these markets depends largely upon marketing arrangements with
distributors, in particular their sales and service expertise and relationships with their respective customers in the
marketplace. Although we intend to replace some of these distributors with a direct sales force, this will take time
and we may keep a distribution model in some markets. We do not control our distributors and they may not be
successful in implementing our marketing plans.
Many of our distributors initially obtain and maintain foreign regulatory approval for sale of our products in
their respective countries. We do not have long-term contracts with many of our distributors, and our distributors
may terminate their relationships with us on little or no notice. In addition, some of our distributors are not
required to purchase any minimum amount of products from us, may sell products that compete with ours or
devote more efforts to selling other products, and may stop selling our products at any time. If we lose any of our
significant distributors, if we fail to recruit and retain additional skilled distributors in these locations, or if our
distributors devote more effort to selling products other than ours, our operations could be adversely affected. We
have experienced turnover with some of our distributors in the past that has adversely affected our short-term
financial results while we transitioned to new distributors. Similar occurrences could happen in the future.
We may not achieve positive cash flow from operations and, as a result, we may require additional capital.
Failure to attract additional capital on acceptable terms could impair our growth.
We may require additional capital to execute our strategies and further expand our business. If our cash
reserves, together with cash available under our credit facility and cash generated internally are insufficient to
fund our operations or our capital requirements, we will require additional debt or equity financing. If we raise
additional capital through the issuance of debt, this debt will be senior to our outstanding shares of capital stock
upon our liquidation. Financing may not be available or, if available, may not be available on terms satisfactory
to us and could result in significant stockholder dilution. In addition, covenants in debt financing arrangements
may restrict our ability to operate our business or obtain additional debt financing. These covenants may also
require us to attain certain levels of financial performance and we may not be able to do so; any such failure may
result in the acceleration of such debt and the foreclosure by our creditors on the collateral we used to secure the
debt. We may also elect to raise additional funds through collaboration, licensing, marketing or similar
arrangements and these arrangements may require us to relinquish valuable rights to our products or proprietary
technologies, or grant licenses that are not favorable to us. If we fail to obtain sufficient additional capital in the
future, we could be forced to curtail our growth strategy by reducing or delaying capital expenditures and
acquisitions, delaying or postponing our product development efforts, including clinical studies, selling assets,
restructuring our operations or refinancing our indebtedness.
We rely on our management information systems for inventory management, distribution and other functions
and to maintain our research and development and clinical data. If our information systems fail to adequately
perform these functions, or if we experience an interruption in their operation, our business and results of
operations could be adversely affected.
The efficient operation of our business is dependent on our management information systems. We rely on
our management information systems to effectively manage accounting, financial, human resources and sales and
marketing functions; manage order entry, order fulfillment and inventory replenishment processes; and maintain
our research and development and clinical data. We do not maintain redundant management information systems.
The failure of our management information systems to perform as we anticipate could disrupt our business and
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product development and could result in decreased sales, increased overhead costs, excess inventory and product
shortages, causing our business and results of operations to suffer. In addition, our management information
systems are vulnerable to damage or interruption from:
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earthquake, fire, flood and other natural disasters;
terrorist attacks and attacks by computer viruses or hackers; and
power loss or the failure of our network infrastructure, telecommunications network or the internet.
Any interruption in the use of our management information systems could have an adverse effect on our
financial condition and results of operations.
From time to time we may become subject to tax audits or similar proceedings, and as a result we may owe
additional taxes, interest and penalties in amounts that may be material.
We are subject to income taxes in many countries, jurisdictions and provinces, including the United States.
In determining our global provision for income taxes, we are required to exercise judgment. Regularly, we make
estimates where the ultimate tax determination is uncertain. While we believe our estimates are reasonable, we
cannot assure you that the final determination of any tax audit or tax-related litigation will not be materially
different from that reflected in our historical income tax provisions and accruals.
In February 2006, we received an audit notification from the Internal Revenue Service (IRS) requesting
materials relating to our 2004 and 2005 federal tax return. As of March 2007, we continue to provide information
relating to the audit and have not received or agreed upon any final adjustment from the IRS.
In addition, we are subject to sales, use and similar taxes in many countries, jurisdictions and provinces,
including those states in the United States where we maintain a physical presence or have a substantial nexus.
These taxing regimes are complex. For example, in the United States, each state and local taxing authority has its
own interpretation of what constitutes a sufficient physical presence or nexus to require the collection and
remittance of these taxes. Similarly, each state and local taxing authority has its own rules regarding the
applicability of sales tax by customer or product type.
At December 31, 2006, we accrued $0.9 million in our financial statements in connection with amounts we
may owe in connection with our tax liabilities worldwide. The assessment of additional taxes, interest and
penalties as a result of audits, litigation or otherwise, could be materially adverse to our current and future results
of operations and financial condition.
Ownership of our common stock by our vascular surgeon customers, including members of our scientific
advisory board, could negatively impact our reputation and as a result, our business and results of operations
could suffer.
The stockholders who own our common stock include members of our scientific advisory board and other
vascular surgeons who may use our devices and may recommend our devices for purchase by the hospitals at
which they perform surgical procedures. The fact that such professionals are also our stockholders could attract
unfavorable attention of the public, regulatory authorities, and the media, especially if the surgeons have not
disclosed their relationships with us. Such perceptions could harm our reputation and could cause our business
and results of operations to suffer.
If we fail to expand our sales force, we could lose market share to our competitors and our results of
operations could suffer.
One of our business strategies is to expand our direct sales force, particularly in markets where we believe
we are currently underrepresented. For example, there are several large markets in the United States where we do
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not have any direct sales coverage. Outside the United States we rely on a small direct sales force in certain
markets and also sell our products through independent sales distributors. Accordingly, there are a number of
large markets where we believe we could expand or initiate direct sales coverage, such as Japan and France. We
may not be able to find a sufficient number of qualified medical device sales personnel to adequately address
these markets in a cost-effective manner. We compete for experienced medical device sales personnel with our
competitors, many of which are larger and have greater resources than we do and some of which may offer more
attractive economic incentives than we do. Even if we are able to attract sales personnel, we may not be able to
effectively train and retain such personnel. There can be no assurance that we will succeed in expanding our sales
force, and difficulties that we encounter could negatively affect our business.
Risks Related to the Regulatory Environment
Our business is subject to complex, costly and burdensome regulations. We could be subject to significant
penalties if we fail to comply.
The production and marketing of our products and our ongoing research and development and clinical trial
activities are subject to extensive regulation and review by numerous governmental authorities both in the
United States and abroad. U.S. and foreign regulations applicable to medical devices are wide-ranging and
govern, among other things, the testing, marketing and premarket clearance or approval of new medical devices,
in addition to regulating manufacturing practices, reporting, promotion and advertising, importing and exporting,
labeling and record-keeping procedures.
Our failure to comply with applicable regulatory requirements could result in governmental agencies or a
court taking action, including any of the following:
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issuing public warning letters to us;
imposing fines and penalties on us;
issuing an injunction preventing us from manufacturing or selling our products;
bringing civil or criminal charges against us;
delaying the introduction of our new products into the market;
ordering a recall of, or detaining or seizing, our products; or
• withdrawing or denying approvals or clearances for our products.
If any or all of the foregoing were to occur, our business, results of operations and reputation could suffer.
If we are not successful in obtaining and maintaining clearances and approvals from governmental agencies,
we will not be able to sell our products and our future growth will be significantly hampered. In order to
market some of our products, notably our EndoFit and UniFit product lines, we will need to obtain approval
of premarket applications from the FDA, which will require data from clinical trials. We have limited
experience with these matters, in particular with conducting clinical trials.
Our products require premarket clearance or approval in the United States and in foreign countries where
they are sold. Each medical device that we wish to market in the United States generally must receive either
510(k) clearance, unless it is exempt, or approval of a premarket application, or PMA, from the FDA before the
product can be marketed or sold. Either process can be lengthy and expensive. The FDA’s 510(k) clearance
procedure, also known as “premarket notification,” is the process used for our currently marketed products in the
United States. This process usually takes from four to twelve months from the date the FDA receives the
application, but may take significantly longer. Although 510(k) clearances have been obtained for all of our
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current products that require clearances, these clearances may be revoked by the FDA if safety or effectiveness
problems develop with the devices. Our new products or significantly modified marketed products could be
denied 510(k) clearance and required to undergo the more burdensome PMA approval process.
The PMA approval process is much more costly, lengthy and uncertain than the premarket notification
process. It generally takes from one to three years from the date the application is submitted to, and filed with,
the FDA, and may take even longer. Achieving premarket approval typically requires extensive clinical trials and
may require the filing of numerous amendments with the FDA over time. We do not have significant experience
in obtaining PMA approval for our products.
Our EndoFit and UniFit products must receive PMA approval before being commercially distributed in the
United States. To successfully obtain PMA approval of our EndoFit and UniFit devices and other devices that we
may develop or acquire, we will need to develop greater regulatory and clinical study expertise than we currently
possess. This task will require us to devote significant resources to the improvement of our regulatory
compliance and clinical study processes, including filling clinical and regulatory positions with personnel who
have the requisite abilities and/or experience. We may not be able to find such personnel or be able to devote the
necessary resources. In addition, our inexperience in these areas may cause significant delays in or otherwise
harm our ability to successfully complete the complex undertaking of obtaining regulatory approval for these
devices. We cannot assure that you that we will ever obtain PMA approval for our EndoFit or UniFit devices.
Our ability to market our products outside the United States is also subject to regulatory approval, including
our ability to demonstrate the safety and effectiveness of our products in the clinical setting. The products for
which we are currently conducting studies are already approved for sale outside of the United States. While our
studies are ongoing, unfavorable data may arise in connection with usage of our products outside the
United States, which could adversely impact approval of our products in the United States. Conversely,
unfavorable data from clinical studies in the United States may adversely impact sales of our products outside the
United States. For example, in July 2006, we received unfavorable preliminary data from our United States
clinical study of our Expedial Vascular Access Graft. The clinical study was designed to establish substantial
equivalence to grafts manufactured using ePTFE for effectiveness in maintaining blood flow through the graft.
The preliminary data from the clinical study suggested that the device did not compare favorably to ePTFE grafts
in this regard. As a result of our review of the clinical study results and less than planned sales in Europe, we
decided to forego further enrollment in the clinical study and cease worldwide production and sale of this device.
Even if regulatory approval or clearance of a product is granted, the approval or clearance could limit the
uses or the claims for which the product may be labeled and promoted, which may limit the market for our
products. If we do not obtain and maintain foreign regulatory or FDA approval with respect to our products, as
applicable, we will not be able to sell our products and our future growth will be significantly hampered.
Modifications to our marketed devices may require new regulatory clearances or premarket approvals, or may
require us to cease marketing or recall the modified devices until clearances or approvals are obtained.
Any modification to a 510(k) cleared device that could significantly affect its safety or effectiveness, or
would constitute a major change in its intended use, requires the submission of another 510(k) or PMA
application to address the change. The FDA requires every manufacturer to make its own determination as to
whether a modification requires a new 510(k) clearance or PMA. Although in the first instance we may
determine that a change does not rise to a level of significance that would require us to make a submission, the
FDA may review and disagree with our determination and can require us to submit a 510(k) or a PMA for a
significant technological change or major change or modification in intended use. If the FDA requires us to
submit a 510(k) or a PMA for any modification to a previously cleared device, we may be required to cease
marketing the device, recall it, and not resume marketing until we obtain clearance or approval from the FDA for
the modified version of the device. Delays in our receipt of regulatory clearance or approval will cause delays in
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our ability to sell our products, which could have a negative effect on our business, results of operations and
prospects. Also, we may be subject to regulatory fines, penalties and/or other sanctions authorized by the Federal
Food, Drug, and Cosmetic Act.
Our EndoFit and UniFit products are in clinical studies. If these clinical studies are unsuccessful, or if the
FDA or other regulatory agencies do not accept or approve the results of such studies, these products may not
successfully come to market and our business prospects may suffer.
We currently have two ongoing clinical studies to support clearance or approval for products that we expect
to contribute significantly to our sales in the future. These studies include a U.S. pivotal study to support a
possible PMA application for our UniFit Abdominal Stent Graft and a Chinese clinical study to support approval
from the Chinese State Food and Drug Administration, or SFDA, of our EndoFit Thoracic Stent Graft for
marketing in China. We cannot assure you that these studies will be successful or that the FDA or SFDA or other
relevant regulatory agencies will accept the results and approve or clear the devices for sale. Further, we continue
to evaluate the potential financial benefits and costs of our clinical studies and the products being evaluated in
them. If we determine that the costs associated with attaining regulatory approval of a product exceed the
potential financial benefits of that product, or if the projected development timeline is inconsistent with our
investment horizon, we may choose to stop a clinical study and/or the development of a product.
In May 2006, we submitted an investigational device exemption, or IDE, supplemental application to the
FDA to begin a pivotal clinical trial to evaluate the safety and effectiveness of the UniFit Abdominal Stent Graft
in the treatment of aorto, aorto-iliac and/or iliac aneurysms. In September 2006, we received conditional approval
from the FDA to commence the pivotal trial, which we refer to as the UNITE study, provided that we resolve the
issues identified in the conditional approval letter to the FDA’s satisfaction. On this basis, we have begun
enrollment in the UNITE study. We plan to enroll 90 patients at up to 14 institutions. The primary effectiveness
endpoint of the study is based on aneurysm exclusion as evaluated through one-year follow-up.
If our UniFit and EndoFit clinical studies are unsuccessful, or if the FDA or other regulatory agencies do not
accept or approve the results of such studies, these products will not successfully come to market and our
business prospects may suffer.
If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation and other applicable
postmarket requirements, our manufacturing operations could be disrupted, our product sales and
profitability could suffer, and we may become subject to a wide variety of FDA enforcement actions.
After a device is placed on the market, numerous regulatory requirements apply. We are subject to
inspection and marketing surveillance by the FDA to determine our compliance with all regulatory requirements.
If the FDA finds that we have failed to comply with any regulatory requirements, it can institute a wide variety of
enforcement actions.
We and some of our suppliers must comply with the FDA’s Quality System Regulation, which governs the
methods used in, and the facilities and controls used for, the design, testing, manufacture, control, quality
assurance, installation, servicing, labeling, packaging, storage and shipping of medical devices. The FDA
enforces the Quality System Regulation through unannounced inspections. We have been, and anticipate in the
future being, subject to such inspections. If we or one of our suppliers fails a Quality System Regulation
inspection, or if a corrective action plan adopted by us or one of our suppliers is not sufficient, the FDA may
bring an enforcement action against us, and our operations could be disrupted and our manufacturing delayed.
In March 2006, the FDA inspected our facilities in Burlington, Massachusetts for three days. The inspection
resulted in the issuance of a formal notification, or a Form FDA-483, listing three observations. Specifically, the
FDA observed that we did not adequately document corrective and preventive actions taken by us to address
quality problems, we did not identify all actions needed to prevent the recurrence of nonconforming product and
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other quality problems, and we had an incomplete procedure for implementing and recording actions taken to
correct and prevent identified quality problems. While we have revised our procedures and conducted additional
training to address the FDA’s findings, we cannot assure you that we have been successful in implementing these
changes or that the FDA will agree that our implementation is adequate. If the FDA finds that we are not in
substantial compliance with the Quality System Regulation, the FDA may issue a public warning letter or take
other enforcement action against us and our operations could be disrupted and our manufacturing delayed.
We are also subject to the FDA’s general prohibition against promoting our products for unapproved or
off-label uses and to the medical device reporting, or MDR, regulations that require us to report to the FDA if our
products may have caused or contributed to a death or serious injury, or if our device malfunctions and a
recurrence of the malfunction would likely result in a death or serious injury. We must also file reports with the
FDA of some device corrections and removals and we must adhere to the FDA’s rules on labeling and
promotion. If we fail to comply with these or other FDA requirements or fail to take adequate corrective action in
response to any significant compliance issue raised by the FDA, the FDA can take significant enforcement
actions, which could harm our business, results of operations and our reputation.
In addition, most other countries, such as Japan, require us to comply with manufacturing and quality
assurance standards for medical devices that are similar to those in force in the United States before marketing
and selling our products in those countries. If we fail to comply, we would lose our ability to market and sell our
products in those foreign countries.
Even after receiving regulatory clearance or approval, our products may be subject to product recalls, which
may harm our reputation and divert managerial and financial resources.
The FDA and similar governmental authorities in other countries have the authority to order mandatory
recall of our products or order their removal from the market if the governmental entity finds that our products
would cause serious adverse health consequences or death. A government mandated or voluntary recall by us
could occur as a result of component failures, manufacturing errors or design defects, including labeling defects.
For example, in 2005 we initiated three voluntary recalls. Two of these recalls related to packaging flaws that
compromised the sterility of the products, and the third recall arose from a labeling error. Any future recall of our
products may harm our reputation with customers and divert managerial and financial resources.
If we do not comply with foreign regulatory requirements to market our products outside the United States,
our business will be harmed.
Sales of medical devices outside the United States are subject to international regulatory requirements that
vary from country to country. These requirements and the amount of time required for approval may differ from
our experiences with the FDA in the United States. In some cases, we rely on our non-U.S. distributors to obtain
premarket approvals, complete product registrations, comply with clinical trial requirements and complete those
steps that are customarily taken in the applicable jurisdictions to comply with governmental and quasi-
governmental regulation. In the future, we expect to continue to rely on distributors in this manner in those
countries where we continue to market and sell our products through them. Failure to satisfy these foreign
regulations would impact our ability to sell our products in these countries and could cause our business to suffer.
There can be no assurance that we will be able to obtain or maintain the required regulatory approvals in these
countries.
Our products are regulated in the European Union under the European Medical Devices Directive
(93/42/EEC). In order to market our medical devices in the European Union, we are required to obtain CE mark
certification, which denotes conformity to the essential requirements of the Medical Devices Directive.
We have received CE mark certification to sell all of our products. Currently, we are awaiting revised CE
mark certificates from our Notified Body for certain products the manufacturing of which has been transferred to
35
our Burlington, Massachusetts facility. A Notified Body is an independent third party designated by
governmental authorities to assess conformity with the Medical Devices Directive.
There can be no assurance that we will be able to obtain a CE mark for new products in the future or for
modifications to our existing products or in the manufacturing of our products, and obtaining a CE mark may
involve a significant amount of time and expense, stringent clinical and preclinical testing, or modification of our
products, or result in limitations being placed on the use of our products in order to obtain approval.
Maintaining a CE mark is contingent upon our continued compliance with applicable European medical
device requirements, including limitations on advertising and promotion of medical devices and requirements
governing the handling of adverse events. There can be no assurance that we will be successful in maintaining
the CE mark for any of our current products. In particular, adverse event reporting requirements in the European
Union mandate that we report incidents which led to death or serious deterioration in health, or incidents that
could have led to death or serious deterioration in health. Under certain circumstances, we could be required to
initiate a recall or removal of our product from the market in order to address product deficiencies or
malfunctions. Any recall of our products may harm our reputation with customers and divert managerial and
financial resources.
Failure to receive or maintain approval would prohibit us from selling these products in member countries
of the European Union, and would require significant delays in obtaining individual country approvals. If we do
not receive or maintain these approvals, our business could be harmed.
Our manufacturing facilities are subject to periodic inspection by European regulatory authorities and
Notified Bodies, and we must demonstrate compliance with the Medical Devices Directive. Any failure by us to
comply with European requirements in this regard may entail our taking corrective action, such as modification
of our policies and procedures. In addition, we may be required to cease all or part of our operations for some
period of time until we can demonstrate that appropriate steps have been taken. There can be no assurance that
we will be found in compliance with such standards in future audits. Our failure to comply may have a material
adverse effect on our business, financial condition and results of operations.
In Japan, the Ministry of Health, Labor and Welfare, or MHLW, regulates medical devices through the
Pharmaceutical Affairs Law, or PAL, which was reformed effective April 1, 2005. Implementation and
enforcement of the reforms are evolving, and compliance guidance from the MHLW is still in development. The
revisions to Japan regulations have resulted in longer lead times for product development.
Any such delay in product registrations could have a negative impact on our results of operations.
If we fail to comply with healthcare regulations, we could face substantial penalties and our business,
operations and financial condition could be adversely affected.
While we do not control referrals of healthcare services, and we do not receive payments directly from
Medicare, Medicaid or other third-party payors, healthcare laws and regulations apply broadly and may apply to
our business. We could be subject to healthcare fraud and patient privacy regulation by the federal government
and the states and international jurisdictions in which we conduct our business. The regulations that may affect
our ability to operate include:
•
the federal healthcare programs Anti-Kickback Statute, which constrains, among other things, our
marketing practices, educational programs, pricing and discounting policies and relationships with
healthcare providers by prohibiting persons from soliciting, receiving or providing remuneration,
directly or indirectly, to induce either the referral of an individual, for an item or service or the
purchasing, recommending, furnishing or arranging for an item or service, for which payment may be
made under a federal healthcare program such as the Medicare or Medicaid programs;
36
•
•
•
•
•
federal false claims laws which prohibit, among other things, individuals or entities from knowingly
presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-
party payors that are false or fraudulent, and which may apply to entities like us, because we provide
coding and billing advice to customers;
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits
executing a scheme to defraud any healthcare benefit program or making false statements relating to
health care matters and which also imposes regulatory and contractual requirements relating to the
privacy, security and transmission of individually identifiable health information;
state laws analogous to each of the above federal laws, such as anti-kickback and false claims laws that
may apply to items or services reimbursed by non-governmental third-party payors, including
commercial insurers, and state laws governing the privacy of health information in certain
circumstances, many of which differ from each other in significant ways and often are not preempted
by HIPAA, thus complicating compliance efforts;
federal physician self-referral prohibitions, such as The Ethics in Patient Referral Act of 1989,
commonly referred to as the federal physician self-referral law or the Stark law, which under certain
circumstances prohibit physicians from referring patients for services paid for by Medicare or
Medicaid to any entity in which the physician or an immediate family member has an ownership,
compensation or other financial interest, unless a specific statutory or regulatory exception applies; and
international regulations similar in nature and scope to the above-referenced requirements, including
the European Union directive on data privacy, which imposes restrictions on the collection, use,
disclosure and processing of personal data.
While we believe that our present and past operations are and have been compliant in all material respects
with the laws and regulations described above, there can be no assurance that we will not be found to be, or
found to have been, in violation of any of such laws or regulations and as a result we may be subject to penalties,
including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any
penalties, damages, fines, or curtailment or restructuring of our operations could adversely affect our ability to
operate our business and our financial results. The risk of our being found in violation of these laws or
regulations is increased by the fact that many of them have not been fully interpreted by the regulatory authorities
or the courts, and their provisions are open to a variety of interpretations. Any action against us for violation of
these laws or regulations, even if we successfully defend against them, could cause us to incur significant legal
expenses and divert our management’s attention from the operation of our business.
Compliance with environmental laws and regulations could be expensive. Failure to comply with
environmental laws and regulations could subject us to significant liability.
Our manufacturing operations and our research and development programs involve the use of hazardous
substances and are subject to a variety of federal, state and local environmental laws and regulations relating to
the storage, use, discharge, disposal, and remediation of, and human exposure to, hazardous substances. Our
research and development and manufacturing operations produce biological waste materials, such as human and
animal tissue, and waste solvents, such as isopropyl alcohol. Regulatory authorities permit these operations, and
the resulting waste materials are disposed of in material compliance with environmental laws and regulations.
Compliance with these laws and regulations is expensive and non-compliance could result in substantial
liabilities, which could exceed our insurance coverage. In addition, our manufacturing operations may result in
the release, discharge, emission or disposal of hazardous substances that could cause us to incur substantial
liabilities, including costs for investigation and remediation.
We cannot assure you that violations of these laws and regulations will not occur in the future or have not
occurred in the past as a result of human error, accidents, equipment failure or other causes. The expense
associated with environmental regulation and remediation could harm our financial condition and operating
results.
37
Inadequate levels of reimbursement from governmental or other third-party payors for procedures using our
products may cause our net sales to decline.
Sales of our products depend in part on the reimbursement by governmental and private healthcare payors to
our hospital and physician customers or their patients for the purchase and use of our products. In the
United States, healthcare providers that purchase our products generally rely on third-party payors, principally
federal Medicare, state Medicaid and private health insurance plans, to pay for all or a portion of the cost of
procedures. Any delays in obtaining, or an inability to obtain, payor coverage and reimbursement for our
products or the services in which our products are used could have a material adverse effect on our business. In
addition, if the reimbursement policies of domestic or foreign governmental or private healthcare payors change,
our customers would likely change their purchasing patterns or the frequency of their purchases of the affected
products.
Changes in healthcare systems in the United States or elsewhere could adversely affect the demand for our
products, as well as the way we conduct business. Third-party payors have adopted, and are continuing to adopt,
a number of healthcare policies intended to curb rising healthcare costs. These policies include:
•
•
•
controls on government-funded reimbursement for healthcare services and price controls on medical
products and services providers;
limitations on coverage and reimbursement for new medical technologies and procedures; and
the introduction of managed care or prospective payment systems in which healthcare providers
contract to provide comprehensive healthcare for a fixed reimbursement amount per person or per
procedure.
We are unable to predict whether federal, state or local healthcare reform legislation or regulation, or private
payor policies, affecting our business may be proposed or enacted in the future, or what effect any such
legislation, regulation or policies would have on our business. Any such legislation, regulation or policies that
affect the coverage and reimbursement of our current or future products, or the procedures utilizing our current or
future products, could cause our net sales to decline.
Outside of the United States, reimbursement systems vary significantly by country. Many foreign markets
have government-managed healthcare systems that govern reimbursement for new devices and procedures. In
most markets, there are private insurance systems as well as government-managed systems. Additionally, some
foreign reimbursement systems provide for limited payments within a given period. These systems are subject to
the same pressures to curb rising healthcare costs and control healthcare expenditures as those in the
United States. If adequate levels of reimbursement from third-party payors outside of the United States are not
obtained, sales of our products outside of the United States may decrease and we may fail to achieve or maintain
significant non-U.S. sales.
Risks Related to Intellectual Property
If we fail to adequately protect our intellectual property rights, or prevent use of our intellectual property by
third parties, we could lose a significant competitive advantage and our business may suffer.
Our success depends in part on obtaining, maintaining and enforcing our patents, trademarks and other
proprietary rights, and our ability to avoid infringing on the proprietary rights of others. We take precautionary
steps to protect our technological advantages and intellectual property. We rely upon patent, trade secret,
copyright, know-how and trademark laws, as well as license agreements and contractual provisions, to establish
our intellectual property rights and protect our products. These measures may only afford limited protection and
may not:
•
•
•
prevent our competitors from duplicating our products;
prevent our competitors from gaining access to our proprietary information and technology; or
permit us to gain or maintain a competitive advantage.
The issuance of a patent is not conclusive as to its validity or enforceability. Any patents we have obtained
or will obtain in the future might also be invalidated or circumvented by third parties. In addition, our pending
patent applications may not issue as patents or, if issued, may not provide commercially meaningful protection,
38
as competitors may be able to design around our patents to produce alternative, non-infringing designs. Should
such challenges to our patents be successful, competitors might be able to market products and use
manufacturing processes that are substantially similar to ours. Additionally, we may not be able to effectively
protect our rights in unpatented technology, trade secrets and confidential information. We have a policy of
requiring key employees and consultants and corporate partners with access to trade secrets or other confidential
information to execute confidentiality agreements. Our confidentiality agreements also require our employees to
assign to us all rights to any inventions made or conceived during their employment with us. We also generally
require our consultants to assign to us any inventions made during the course of their engagement by us. There
can be no assurance, however, that these agreements will provide meaningful protection or adequate remedies for
us in the event of unauthorized use, transfer or disclosure of confidential information or inventions.
In addition, the laws of foreign countries may not protect our intellectual property rights effectively or to the
same extent as the laws of the United States. If our intellectual property rights are not adequately protected, we
may not be able to commercialize our technologies, products or services and our competitors could
commercialize similar technologies, which could result in a decrease in our sales and market share.
If third parties claim that we infringe upon their intellectual property rights, we may incur liabilities and costs,
and we may have to redesign or discontinue selling the affected product.
The medical device industry is litigious with respect to patents and other intellectual property rights.
Companies operating in our industry routinely seek patent protection for their product designs, and many of our
principal competitors have large patent portfolios. Companies in the medical device industry have used
intellectual property litigation to gain a competitive advantage. Whether a product infringes a patent involves
complex legal and factual issues, the determination of which is often uncertain. We face the risk of claims that
we have infringed on third parties’ intellectual property rights, and we cannot assure you that our products or
methods do not infringe the patents or other intellectual property rights of third parties. Prior to launching major
new products in our key markets, we typically evaluate existing intellectual property rights. However, our
competitors may also have filed for patent protection that is not as yet a matter of public knowledge or claim
trademark rights that have not been revealed through our availability searches. Our efforts to identify and avoid
infringing on third parties’ intellectual property rights may not always be successful. Any claims of patent or
other intellectual property infringement, even those without merit, could:
•
•
•
•
•
•
•
•
be expensive and time consuming to defend;
result in us being required to pay significant damages to third parties for past use of the asserted
intellectual property;
harm our reputation;
cause us to cease making or selling products that incorporate the challenged intellectual property;
require us to redesign, reengineer or rebrand our products, which may not be possible and could be
costly and time consuming if it is possible to do so at all;
require us to enter into royalty or licensing agreements in order to obtain the right to use a third party’s
intellectual property, which agreements may not be available on terms acceptable to us or at all;
divert the attention of our management and key personnel from other tasks important to the success of
our business; or
result in our customers or potential customers deferring or limiting their purchase or use of the affected
products until resolution of the litigation.
It is also possible that one of our competitors could claim that our manufacturing process violates an
existing patent. If we were unsuccessful in defending such a claim, we may be forced to stop production at our
manufacturing facility.
39
In addition, new patents obtained by our competitors could threaten a product’s continued life in the market
even after it has already been introduced. If our business is successful, the possibility may increase that others
will assert infringement claims against us.
In addition, we may become subject to interference proceedings conducted in the United States Patent
Office or opposition proceedings conducted in foreign patent offices challenging the priority of invention or the
validity of our patents. For example, Boston Scientific Corporation initiated opposition proceedings in 2005 and
2006, respectively, in the European Patent Office to oppose the Company’s granted European patent number
1,202,682, or the 682 patent, related to an ePTFE intraluminal device such as certain of our EndoFit and UniFit
stent grafts, and to oppose the Company’s granted European patent number 1,148,838, or the 838 patent, related
to an ePTFE vascular prosthesis such as certain of our EndoFit and UniFit stent grafts. Depending on the course
of the opposition proceedings, the granted patent claims in the 682 patent will be amended or may be cancelled
while the 838 patent may survive unamended, may be amended or may be cancelled. We can not assure you that
we will be successful in defending these oppositions.
We may become involved in lawsuits and administrative proceedings to protect, defend or enforce our patents
that would be expensive and time consuming.
In order to protect or enforce our patent rights, we may initiate patent litigation or interference or opposition
proceedings against third parties in the United States or in foreign countries. The defense of intellectual property
rights, including patent rights through lawsuits, interference or opposition proceedings, and other legal and
administrative proceedings can be costly and can divert our technical and management personnel from their
normal responsibilities. Such costs increase our operating losses and reduce our resources available for
development activities. An adverse determination of any litigation or defense proceedings could put one or more
of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of
not issuing.
Furthermore, because of the substantial amount of discovery required in connection with intellectual
property litigation, there is a risk that some of our confidential information could be compromised by disclosure
during this type of litigation. For example, during the course of this kind of litigation and despite protective
orders entered by the court, confidential information may be inadvertently disclosed in the form of documents or
testimony in connection with discovery requests, depositions or study testimony. This disclosure could materially
adversely affect our business and financial results.
If we fail to observe the terms of our agreements with third-party patent holders, including our agreement with
Bard Peripheral Vascular, Inc., we may lose the ability to manufacture, market or sell some of our products.
Our arrangement with Bard also precludes us from assigning the agreement to a third party, including in
connection with the sale of more than 30% of our capital stock or all or substantially all of our assets, without
the prior consent of Bard.
Certain aspects of our products are the subject of patents held by third parties. We manufacture, market and
sell these products pursuant to license agreements with these third parties. These arrangements require us to pay
royalties, typically determined as a percentage of our net sales for the underlying product. If we fail to make
these payments or otherwise fail to observe the terms of these agreements, we may lose our ability to sell these
products. For example, we manufacture, market and sell our aortic stent grafts pursuant to a sublicense we
receive from Bard Peripheral Vascular, Inc., a subsidiary of C.R. Bard, Inc., to a U.S. patent covering aspects of
ePTFE. Our arrangement with Bard precludes us from assigning the agreement to a third party, including in
connection with the sale of more than 30% of our capital stock or all or substantially all of our assets, without the
prior consent of Bard. The loss by us of our right to manufacture, market and sell our aortic stent graft products
could adversely affect our business and results of operations, perhaps materially.
40
Risks Related to Our Common Stock
Our stock price may be volatile, and your investment in our common stock could suffer a decline in value.
There has been significant volatility in the market price and trading volume of equity securities that is
unrelated to the financial performance of the companies issuing the securities. These broad market fluctuations
may negatively affect the market price of our common stock. You may not be able to resell your shares at or
above the price at which you purchased them due to fluctuations in the market price of our common stock caused
by changes in our operating performance or prospects and other factors.
Some specific factors that may have a significant effect on our common stock market price include:
•
•
•
•
•
•
•
•
•
•
•
•
•
actual or anticipated fluctuations in our operating results or future prospects;
our announcements or our competitors’ announcements of new products;
the public’s reaction to our press releases, our other public announcements and our filings with the
Securities and Exchange Commission, or SEC;
strategic actions by us or our competitors, such as acquisitions or restructurings;
new laws or regulations or new interpretations of existing laws or regulations applicable to our
business;
changes in accounting standards, policies, guidance, interpretations or principles;
changes in our growth rates or our competitors’ growth rates;
developments regarding our patents or proprietary rights or those of our competitors;
our inability to raise additional capital;
public concern as to the safety or efficacy of our products;
changes in financial markets or general economic conditions, including those resulting from war,
incidents of terrorism and responses to such events;
sales of common stock by us, our directors, officers or principal stockholders; and
changes in stock market analyst recommendations or earnings estimates regarding our common stock,
other comparable companies or our industry generally.
In the past, following periods of volatility in the market price of a company’s securities, securities class
action litigation has often been instituted. A securities class action suit against us could result in substantial costs
and divert our management’s attention and resources that would otherwise be used to benefit the future
performance of our business.
Our quarterly operating results are volatile, which may cause our stock price to decline.
Our quarterly results of operations have varied significantly in the past and are likely to vary significantly in
the future due to a number of factors, many of which are outside of our control, including:
•
•
•
changes in our ability to obtain products and product components that are manufactured for us by third
parties, as well as variations in prices of these products and product components;
delays in the development or commercial introduction of new versions of our products or components
we use in our products;
our ability to attain and maintain production volumes and quality levels for our products and product
components;
41
•
•
•
•
•
•
•
•
•
effects of domestic and foreign economic conditions on our industry and/or customers;
changes in the demand for our products;
changes in the mix of products we sell;
strategic actions by us, such as acquisitions of additional businesses, products or technologies;
delays in obtaining regulatory clearance for new versions of our products;
increased product and price competition;
changes in the availability of third-party reimbursement for our products;
the loss of key sales personnel or distributors; and
seasonality in the sales of our products.
Due to the factors summarized above, we do not believe that period-to-period comparisons of our results of
operations are necessarily meaningful, or should necessarily be relied upon to predict future results.
Our directors, officers and principal stockholders have significant voting power and may take actions that may
not be in the best interests of our other stockholders.
As of February 1, 2007, our directors, officers and principal stockholders holding more than 5% of our
common stock collectively control approximately 50.9% of our outstanding common stock, assuming the
exercise of all options held by such persons. As a result, these stockholders, if they act together, would be able to
control the management and affairs of our company and most matters requiring stockholder approval, including
the election of directors and approval of significant corporate transactions. This concentration of ownership may
have the effect of delaying or preventing a change in control, might adversely affect the market price of our
common stock and may not be in the best interests of our other stockholders.
Future acquisitions that we make may be dilutive to our current stockholders.
We intend to pursue the acquisition of complementary products, technologies or businesses, and in
connection with these acquisitions we may use substantial portions of our available cash or make dilutive
issuances of securities. In addition, an acquisition could impair our operating results by causing us to incur debt
or requiring us to recognize acquisition expenses or amortize, depreciate or impair acquired assets. This debt
would be senior to our outstanding shares of capital stock upon our liquidation.
The requirements of being a public company may strain our resources and distract management.
As a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934,
as amended, or the Exchange Act, the Sarbanes-Oxley Act of 2002 as well as other federal and state laws. These
requirements may place a strain on our people, systems and resources. The Exchange Act requires that we file
annual, quarterly and current reports with respect to our business and financial condition. The Sarbanes-Oxley
Act requires that we maintain effective disclosure controls and procedures and internal controls over financial
reporting. In order to maintain and improve the effectiveness of our disclosure controls and procedures and
internal controls over financial reporting, significant resources and management oversight are required. This may
divert management’s attention from other business concerns, which could have a material adverse effect on our
business, financial condition, results of operations and cash flows.
We will be exposed to risks relating to evaluation of controls required by Section 404 of the Sarbanes-Oxley
Act.
Changing laws, regulations and standards relating to corporate governance and public disclosure, including
the Sarbanes-Oxley Act and related regulations implemented by the SEC and the NASDAQ Global Market, are
42
creating uncertainty for public companies, increasing legal and financial compliance costs and making some
activities more time consuming. We are evaluating our internal controls systems to allow management to report
on, and our independent auditors to attest to, our internal controls. We are performing the system and process
evaluation and testing (and any necessary remediation) required to comply with the management certification and
auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We cannot be certain as to the timing
of completion of our evaluation, testing and remediation actions or the impact of the same on our operations
since there is presently no precedent available by which to measure compliance adequacy. If we are not able to
implement the requirements of Section 404 in a timely manner or with adequate compliance, we may be subject
to sanctions or investigation by regulatory authorities, including the SEC or the NASDAQ Global Market. This
type of action could adversely affect our financial results or investors’ confidence in our company and our ability
to access capital markets, and could cause our stock price to decline. In addition, the controls and procedures that
we will implement may not comply with all of the relevant rules and regulations of the SEC and the NASDAQ
Global Market. If we fail to develop and maintain effective controls and procedures, we may be unable to
provide the required financial information in a timely and reliable manner.
Our corporate documents and Delaware law contain provisions that could discourage, delay or prevent a
change in control of our company.
Provisions in our restated certificate of incorporation and restated bylaws may discourage, delay or prevent
a merger or acquisition involving us that our stockholders may consider favorable. For example, our restated
certificate of incorporation authorizes our board of directors to issue up to 5,000,000 shares of “blank check”
preferred stock. Without stockholder approval, the board of directors has the authority to attach special rights,
including voting and dividend rights, to this preferred stock. With these rights, preferred stockholders could make
it more difficult for a third party to acquire us. In addition, our restated certificate of incorporation provides for a
staggered board of directors, whereby directors serve for three year terms, with approximately one third of the
directors coming up for reelection each year. Having a staggered board makes it more difficult for a third party to
obtain control of our board of directors through a proxy contest, which may be a necessary step in an acquisition
of us that is not favored by our board of directors.
We are also subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation
Law. Under these provisions, if anyone becomes an “interested stockholder,” we may not enter into a “business
combination” with that person for three years without special approval, which could discourage a third party
from making a takeover offer and could delay or prevent a change of control. For purposes of Section 203,
“interested stockholder” means, generally, someone owning 15% or more of our outstanding voting stock or an
affiliate of ours that owned 15% or more of our outstanding voting stock during the past three years, subject to
certain exceptions as described in Section 203.
We do not expect to pay cash dividends in the foreseeable future.
We do not anticipate paying cash dividends in the foreseeable future. The payment of cash dividends will
depend on our earnings, capital requirements, financial condition, prospects and other factors our board of
directors may deem relevant and may also be restricted by contractual agreements. If we do not pay dividends,
our stock may be less valuable because a return on your investment will only occur if our stock price appreciates.
Item 1B. Unresolved Staff Comments
Not applicable.
Item 2.
Properties
Our principal worldwide executive, distribution and manufacturing operations are located at a 27,098 square
foot leased facility and a nearby 7,477 square foot leased facility, located in Burlington, Massachusetts. In
43
addition, our international operations are headquartered at a 12,841 square foot leased facility located in
Sulzbach, Germany, and our Asia operations are located at a 2,140 square foot leased facility located in Tokyo,
Japan. The leases for our two Burlington facilities expire in 2008 and the leases for our Sulzbach and Tokyo
facilities expire in 2010 and 2007, respectively. Based on our current operating plan, we believe our current
facilities are adequate.
Item 3.
Legal Proceedings
We are not party to any material pending or threatened litigation.
Item 4.
Submission of Matters to a Vote of Security Holders
Not applicable.
44
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities
Market Information
Our common stock began trading on The NASDAQ Global Market under the symbol “LMAT” on
October 19, 2006. The following table sets forth, for the period indicated, the high and low sales closing prices of
our common stock on The NASDAQ National Market.
Year Ended December 31, 2006
High
Low
Fourth Quarter (from October 19 to December 31) . . . . . . . . . . . . . . . . . . . . . . . . . . .
$6.45
$5.50
Holders of Record
On March 28, 2007, the closing price per share of our common stock was $5.96, as reported on The
NASDAQ Global Market, and we had approximately 289 stockholders of record.
Dividend Policy
We have never paid a cash dividend and have no present intention to pay cash dividends in the foreseeable
future. We intend to retain any future earnings for use in our business.
Securities Authorized for Issuance under Equity Compensation Plans
The following table sets forth information regarding our equity compensation plans in effect as of
December 31, 2006. Each of our equity compensation plans is an “employee benefit plan” as defined by
Rule 405 of Regulation C of the Securities Act of 1933.
Plan category
Number of securities
to be issued upon
exercise of
outstanding options,
warrants and rights
(a)
Weighted-average
exercise price of
outstanding
options, warrants
and rights
(b)
Number of
securities remaining
available for future
issuance under
equity
compensation plans
(excluding
securities reflected
in column (a))
(c)
Equity compensation plans approved by security
holders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equity compensation plans not approved by
1,601,254
security holders . . . . . . . . . . . . . . . . . . . . . . . .
—
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,601,254
$6.07
—
$6.07
612,928
—
612,928
Stock Price Performance Graph
Set forth below is a graph comparing the cumulative total stockholder return on LeMaitre’s common stock
with the NASDAQ US Composite Index, the NASDAQ Medical Equipment Index and a peer group for the
period covering LeMaitre’s initial public offering on October 19, 2006 through the end of LeMaitre’s fiscal year
ended December 31, 2006. The graph assumes an investment of $100.00 made at the opening of trading on
October 20, 2006, in (i) LeMaitre’s common stock, (ii) the stocks comprising the NASDAQ US Composite
Index, (iii) stocks comprising the NASDAQ Medical Equipment Index, and (iv) the stocks comprising of a peer
group.
45
COMPARISON OF CUMULATIVE TOTAL RETURN*
Among LeMaitre Vascular, Inc, The NASDAQ Composite Index,
The NASDAQ Medical Equipment Index And A Peer Group
$110
$108
$106
$104
$102
$100
$98
$96
$94
$92
$90
10/20/06
12/31/06
LeMaitre Vascular, Inc
NASDAQ Composite
NASDAQ Medical Equipment
Peer Group
* $100 invested on 10/20/06 in stock or on 9/30/06 in index-including reinvestment of dividends.
Fiscal year ending December 31.
LeMaitre Vascular, Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NASDAQ Composite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NASDAQ Medical Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Peer Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
100.00
100.00
100.00
100.00
93.02
107.40
107.34
92.23
10/20/06
12/31/06
LeMaitre’s fiscal year ends on the last day of December each year; data in the above table reflects market
values for the Company’s stock and NASDAQ and peer group indices as of the close of trading on the last
trading day of year presented.
The peer group includes the following companies: Angiodynamics Inc., Endologix Inc., EV3 Inc.,
Foxhollow Technologies Inc., Integra Lifesciences, Kensey Nash Corp. and Vascular Solutions Inc.
Recent Sales of Unregistered Securities
In April 2006, we issued 1,443 shares of our common stock to a consultant in consideration of services
provided to us. The issuance of these shares was exempt either pursuant to Rule 701, as a transaction pursuant to
a compensatory benefit plan, or pursuant to Section 4(2), as a transaction by an issuer not involving a public
offering.
In connection with our initial public offering, all outstanding shares of our Series A convertible preferred
stock were converted into 1,274,620 shares of common stock.
46
The issuance of securities described above were deemed to be exempt from registration under the Securities
Act of 1933 in reliance on Section 4(2) of the Securities Act of 1933 as transactions by an issuer not involving
any public offering. The recipients of securities in each such transaction represented their intention to acquire the
securities for investment only and not with a view to or for sale in connection with any distribution thereof and
appropriate legends were affixed to the share certificates and other instruments issued in such transactions. The
sales of these securities were made without general solicitation or advertising.
During the period from January 1, 2006 through the closing of our initial public offering on October 19,
2006, we granted options to purchase an aggregate of 106,143 shares of our common stock pursuant to our stock
option plans, at a weighted average exercise price of $12.36 per share. In addition, from January 1, 2006 through
October 19, 2006, we also issued 20,004 shares of common stock in connection with the exercise of outstanding
options under our stock option plans by optionees, at a weighted exercise price of $0.28 per share. These option
exercises resulted in aggregate proceeds to us of approximately $6,000. No underwriters were involved in the
foregoing stock or option issuances. The foregoing stock and option issuances were exempt from registration
under the Securities Act of 1933, as amended, either pursuant to Rule 701 under the Act, as transactions pursuant
to a compensatory benefit plan, or pursuant to Section 4(2) under the Act, as a transaction by an issuer not
involving a public offering.
On October 19, 2006, we completed our initial public offering of 5,500,000 shares of our common stock at a
price to the public of $7.00 per share for an aggregate offering price of $38.5 million. The offer and sale of all of
the shares in the initial public offering were registered under the Securities Act of 1933, as amended, pursuant to
a registration statement on Form S-1 (File No. 333-133532), which was declared effective by the Securities and
Exchange Commission on October 18, 2006. Goldman, Sachs & Co., CIBC World Markets Corp., Cowen and
Company, LLC and Thomas Weisel Partners LLC were the managing underwriters of the initial public offering.
The offering commenced on October 19, 2006 and did not terminate until after the sale of all of the securities
registered in the registration statement.
We received aggregate net proceeds of approximately $35.8 million, after deducting underwriting discounts
and commissions of $2.7 million. We incurred approximately $2.9 million for additional expenses associated
with the initial public offering. None of the underwriting discounts and commissions or offering expenses were
incurred or paid to directors or officers of ours or their associates or to persons owning 10% or more of our
common stock or to any affiliates of ours. From the effective date of the registration statement through
December 31, 2006, we used $3.9 million of the net proceeds of our initial public offering to pay down all
outstanding debt. No payments for such expenses were directly or indirectly to (i) any of our directors, officers or
their associates, (ii) any person(s) owning 10% or more of any class of our equity securities or (iii) any of our
affiliates. At December 31, 2006, we had approximately $30.8 invested in cash equivalents and marketable
securities.
Issuer Purchases of Equity Securities
During the quarter ended December 31, 2006, there were no purchases made by us or on our behalf, or by
any “affiliated purchasers” of shares of our common stock.
47
Item 6.
Selected Financial Data
You should read the following selected consolidated financial data in conjunction with our consolidated
financial statements and the related notes which are included elsewhere in this Annual Report and the
“Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this
Annual Report. We have derived the consolidated statement of operations data for the years ended December 31,
2004, 2005 and 2006 and the consolidated balance sheet data as of December 31, 2005 and 2006 from our
audited consolidated financial statements, which are included elsewhere in this Annual Report. We have derived
the consolidated statement of operations data for the years ended December 31, 2002 and 2003 and the
consolidated balance sheet data as of December 31, 2002, 2003 and 2004 from our audited consolidated financial
statements, which are not included in this Annual Report. Our historical results for any prior period are not
necessarily indicative of results to be expected for any future period.
Year ended December 31,
2002
2003
2004
2005
2006
(in thousands, except per share data)
Consolidated Statement of Operations Data:
Net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$17,364
6,080
$20,664
6,208
$26,183
7,780
$30,727
8,927
$34,628
9,367
Gross profit: . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11,284
14,456
18,403
21,800
25,261
Operating expenses:
Sales and marketing . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . .
Research and development . . . . . . . . . . . . . . . . . . . . . . .
Restructuring charges . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5,592
3,564
1,295
—
—
7,252
4,530
2,265
733
—
9,654
5,037
2,120
435
—
10,960
6,405
3,015
998
—
15,183
7,105
3,301
257
94
Total operating expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10,451
14,780
17,246
21,378
25,940
Income (loss) from operations: . . . . . . . . . . . . . . . . . . . . . .
Other income (expense):
Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign currency gain (loss) . . . . . . . . . . . . . . . . . . . . . .
Other income (expense), net . . . . . . . . . . . . . . . . . . . . . .
Total other income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) before income tax:
. . . . . . . . . . . . . . . . . . . .
Provision for (benefit from) income taxes . . . . . . . . . . . . .
Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
Net income (loss) per share available for common
shareholders:
833
(324)
1,157
422
(679)
5
(154)
311
(34)
128
961
478
483
3
(144)
191
(22)
28
(296)
(74)
9
(137)
169
(57)
(16)
1,141
214
4
(182)
(217)
551
156
578
523
299
(296)
228
(72)
159
(520)
652
$ (222) $
927
$
55
$ (1,172)
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
0.06
$ (0.03) $
0.10
0.05
$ (0.03) $
0.10
$
$
0.01
$ (0.15)
0.01
$ (0.15)
Weighted-average shares outstanding:
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7,291
7,693
7,525
7,525
7,941
8,354
8,246
8,701
9,904
9,904
48
Consolidated Balance Sheet Data:
Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . .
Marketable securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revolving line of credit and current portion of long-term
December 31,
2002
2003
2004
2005
2006
$
337
$
559
$ 1,024
$
817
5,936
12,718
7,029
16,894
9,102
20,501
10,817
25,068
$15,391
15,417
43,641
56,963
debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
932
522
432
1,142
0
Current liabilities (excluding revolving line of credit and
current portion of long-term debt) . . . . . . . . . . . . . . . . . . .
Long-term liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . .
2,362
1,400
4,694
8,024
2,977
3,121
6,620
10,274
3,374
1,882
5,688
14,813
3,953
1,437
6,532
18,536
5,378
886
6,264
50,699
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read this discussion together with our consolidated financial statements, the related notes to
these financial statements and other financial information included elsewhere in this Annual Report on
Form 10-K . The following discussion may contain predictions, estimates and other forward-looking statements
that involve a number of risks and uncertainties, including those discussed under “Risk Factors” and elsewhere
in this Annual Report on Form 10-K These risks could cause our actual results to differ materially from any
future performance suggested below.
Overview
We are a medical device company that develops, manufactures and markets medical devices for the
treatment of peripheral vascular disease. Our principal product offerings are sold throughout the world, primarily
in the United States, the European Union and, to a lesser extent, Japan. We estimate that the annual worldwide
market addressed by our ten current product lines exceeds $500 million and that the annual worldwide market for
all peripheral vascular devices exceeds $3 billion and is growing at 8% per year. We have used acquisitions as a
primary means of further accessing the larger peripheral vascular device market, and we expect to continue to
pursue this strategy in the future. We currently manufacture all of our product lines in our Burlington,
Massachusetts headquarters.
Our products are used by vascular surgeons who treat peripheral vascular disease through both open surgical
methods as well as more recently adopted endovascular techniques. In contrast to interventional cardiologists and
interventional radiologists, neither of whom are certified to perform open surgical procedures, vascular surgeons
can perform both open surgical and minimally invasive endovascular procedures, and are therefore uniquely
positioned to provide patients with a wider range of treatment options.
We believe that the purchasing volume of the vascular surgeon will increase and that the changing product
needs of the vascular surgeon present us with attractive opportunities to sell new devices. As a result, we have
sought out and acquired new products and businesses that address these needs, such as our acquisition of the
EndoFit Thoracic Stent Graft and UniFit Abdominal Stent Graft product lines and related operations in 2005, and
our signing of a three year distribution agreement, commencing January 1, 2007, as the exclusive distributor of
the Endologix Powerlink System in ten European countries.
We currently offer ten product lines across three product categories, excluding Powerlink. We attribute our
sales growth to the expansion of our direct sales force, conversion of the United States and certain foreign
markets from a distributor sales model to a direct sales model, sales of newly acquired products and the higher
49
selling prices of these newly acquired products. Prior to September 2005, we also derived a limited amount of
revenue from manufacturing devices under private label, although we have discontinued nearly all of these
activities.
We evaluate the sales performance of our various product lines utilizing criteria that varies based upon the
position of each product line in its expected life cycle. For established products, such as our Pruitt-Inahara
Carotid Shunt product line, we typically review unit sales and selling prices. For more recently introduced
products, such as our EndoFit and UniFit Aortic Stent Grafts, we typically focus instead upon new account
generation and customer retention.
Our business opportunities include the following:
•
•
•
•
the continued expansion of our sales force in the United States, Europe and Japan;
the addition of complementary products through further acquisitions;
updating of existing products through research and development; and
the introduction of our products in new markets upon achievement of regulatory approvals in these
markets.
We are currently pursuing each of these opportunities.
These opportunities are balanced by several challenges, such as the penetration of our product offerings in
current and new markets, the recruitment and retention of key employees and competition from other products
and techniques. In addition, our clinical studies may not succeed, our established products may be overtaken by
new technologies, and we may not successfully compete against companies which possess substantially greater
resources. Furthermore, our results of operations may suffer if we are unable to identify, negotiate, complete and
integrate suitable acquisitions.
To address these risks, we will seek to expand our sales and marketing efforts, continue to pursue research
and development as well as acquisition opportunities to expand our product offerings and further fund our
clinical studies.
To assist us in evaluating our business strategies, we regularly monitor long-term technology trends in the
peripheral vascular device market. Additionally, we consider the information obtained from discussions with the
medical community in connection with the demand for our products, including potential new product launches.
We also use this information to help determine our competitive position in the peripheral vascular device market
and our manufacturing capacity requirements.
In April 2003, we acquired the Expedial Vascular Access Graft product line from Credent Limited, a UK
company, for total consideration of $1.9 million. At the time of the acquisition, the Expedial Vascular Access
Graft had already received a CE mark and was being sold in the European Union and other foreign jurisdictions.
In May 2004, we commenced a clinical study in the United States to collect data to submit to the FDA in support
of 510(k) clearance for this device. In July 2006, we received preliminary data from the clinical study conducted
for the period from April 8, 2004 to June 28, 2006 suggesting that the device may not compare favorably to
ePTFE grafts. There were no significant safety issues identified in the preliminary data collected in the clinical
study. As a result of our review of the clinical study results and less than planned sales in Europe, we decided to
forego further enrollment in the clinical study and cease the production and sale of this device. As a result, during
the second quarter of 2006, we recognized non-cash charges to operations of $0.7 million. Net sales of this
device were approximately $26,000 for 2006 and $0.4 million for 2005 and 2004, respectively. During the fourth
quarter of 2006, we sold certain manufacturing equipment, inventory and intellectual property related to our
Expedial Vascular Access Graft product line to CardioTech International, Inc. for total consideration of $0.4
million plus a five percent royalty on CardioTech’s net sales of its CardioPass brand coronary artery bypass graft
for a period of five years following the first commercial sale of a CardioPass graft. Clinical trials on the
50
CardioPass graft have only recently been initiated and there can be no assurance that it will ever be
commercialized. As a result of the sale, we subsequently adjusted the impairment charge for $0.3 million for the
gain on the sale of the intellectual property and equipment which is recorded as a adjustment to restructuring
charges and adjusted $12,000 against cost of sales for the inventory sale.
We sell our products primarily through a direct sales force. As of December 31, 2006, our sales force was
comprised of 47 bag-carrying sales representatives in the United States, Canada, the European Union and Japan.
We also sell our products through a network of distributors in various countries outside of the United States and
Canada. Our worldwide headquarters are located in Burlington, Massachusetts. Our international operations are
headquartered in Sulzbach, Germany. We also have a sales office located in Tokyo, Japan. For the year ended
December 31, 2006, approximately 87% of our net sales were generated through direct sales.
Sales and Expense Components
The following is a description of the primary components of our net sales and expenses.
Net sales. We derive our net sales from the sale of our products, less discounts and returns. Most of our
sales are generated by our direct sales force and are shipped and billed to hospitals or clinics throughout the
world. In countries where we do not have a direct sales force, sales are primarily generated by shipments to
distributors who, in turn, sell to hospitals and clinics. In those limited cases where our products are held on
consignment at a hospital or clinic, we generate sales at the time the product is used in surgery rather than at
shipment.
Cost of sales. We manufacture nearly all of the products that we sell. Our cost of sales consists primarily of
manufacturing personnel, raw materials and components, depreciation of property and equipment and other
allocated manufacturing overhead, as well as freight expense we pay to ship products to customers.
Sales and marketing. Our selling and marketing expense consists primarily of salaries, commissions, travel
and entertainment, attendance at medical society meetings, training programs, advertising and product
promotions, direct mail and other marketing costs.
General and administrative. General and administrative expense consists primarily of executive, finance
and human resource expense, legal and accounting fees, information technology expense and insurance expense.
Research and development. Research and development expense includes costs associated with the design,
development, testing, enhancement and regulatory approval of our products and amortization of patents costs. It
also includes costs associated with design and execution of clinical studies and regulatory submissions, and costs
to register, maintain and defend our intellectual property.
Restructuring. Restructuring expense includes costs directly associated with closing plant facilities to
consolidate our manufacturing operations and other moving expenses. These costs relate to lease termination
expenses, severance and retention costs for terminated employees and other expenses associated with
restructuring our operations.
Other income (expense). Other income (expense) primarily includes interest income and expense, foreign
currency gains (losses) and other miscellaneous gains (losses).
Income tax expense. We are subject to federal and state income taxes for earnings generated in the
United States, which includes the results of our operations in the United Kingdom until 2005, and foreign taxes
on earnings of our wholly-owned German and Japanese subsidiaries. Our consolidated tax expense is affected by
the mix of our taxable income (loss) between the United States, Germany and Japan, permanent items, discrete
items, and amortization of goodwill for U.S tax reporting purposes.
51
Results of Operations
Comparison of the Year Ended December 31, 2006 to the Year Ended December 31, 2005
The following table sets forth, for the periods indicated, our results of operations and the change between
the specified periods expressed as a percent increase or decrease:
2006
2005
Net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$34,628
9,367
$30,727
8,927
Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25,261
21,800
Operating expenses:
Sales and marketing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restructuring charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15,183
7,105
3,301
257
94
10,960
6,405
3,015
998
0
Percent
change
13%
5%
16%
39%
11%
9%
(74%)
NM
Income (loss) from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(679)
422
NM
Other income (expense):
Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign currency (loss) gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) before income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision for income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
299
(296)
228
(72)
(520)
652
4
(182)
(217)
551
578
523
NM
63%
NM
NM
NM
25%
Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ (1,172)
$
55
NM
Net Sales by Product Category:
Endovascular & Dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vascular
General Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Branded Sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Private Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 9,833
20,992
3,803
34,628
0
$ 6,774
19,654
3,600
30,028
699
45%
7%
6%
15%
NM
$34,628
$30,727
13%
Net Sales by Geography:
United States and Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Outside the United States and Canada . . . . . . . . . . . . . . . . . . . . .
$22,362
12,266
$20,056
10,671
$34,628
$30,727
12%
15%
13%
Net sales. Net sales increased 13% to $34.6 million for the year ended 2006 from $30.7 million for the year
ended 2005. Excluding the discontinued Expedial Vascular Access Graft product line and private label sales,
2006 net sales increased 17% over 2005 net sales. Sales in our endovascular and dialysis access product category
increased by 45%, while sales in our vascular and general surgery product categories grew by 7% and 6%,
respectively, over the same period in the previous year. Increases were driven by increased unit sales in the
endovascular and dialysis access product category, an expansion of the world wide sales force, higher average
selling prices across all product categories and an increase in direct marketing efforts during 2006. Direct to
hospital net sales also increased from 84% of total revenues in 2005, to 87% in 2006.
Net sales by geography. Net sales in the United States and Canada increased 12% to $22.4 million in 2006
compared to $20.1 million in 2005. Net sales outside of the United States and Canada increased 15% to $12.3
million
52
for 2006 compared to $10.7 million in 2005. Direct to hospital net sales represented 64% of the total net sales
outside the United States and Canada in 2006, compared to 59% in 2005.
Gross profit. Gross profit increased 16% to $25.3 million in 2006 from $21.8 million in 2005. This gross
profit increase was driven primarily by higher average selling prices across nearly all product categories as well
as cost savings resulting from the consolidation of manufacturing operations to our Burlington, Massachusetts
facility in 2005 and 2006. This gross profit increase was offset partially by a $0.3 million inventory write-down
related to our decision to cease the production and sale of our Expedial Vascular Access Graft product line in the
second quarter of 2006.
Sales and marketing. Sales and marketing expenses increased 39% to $15.2 million in 2006, from
$11.0 million in 2005. This increase was driven primarily by the addition of sales professionals in 2006, as well
as an increase in marketing and advertising of our product lines primarily through direct mail, journal ads and
trade shows. At the end of 2006, we employed 47 bag-carrying sales representatives worldwide, as compared to
30 at the end of 2005.
General and administrative. General and administrative expense increased 11% to $7.1 million in 2006
from $6.4 million in 2005. The increase was driven primarily by the higher costs associated with being a public
company, including increased finance and legal staff, professional fees and increased insurance expense. General
and administrative expenses for 2005 included an accrual for sales tax exposure of $0.2 million that did not
reoccur in 2006, as well as $0.2 million of general and administrative expenses related to our Phoenix, Arizona
and Brymbo, Wales plants, which were consolidated into the Burlington, Massachusetts facility during 2005 and
the first quarter of 2006.
Research and development. Research and development expense increased 9% to $3.3 million in 2006 from
$3.0 million in 2005. This increase was mainly a result of higher regulatory costs related to the UniFit and
EndoFit Aortic Stent Grafts, the hiring of product development engineers and the hiring of additional regulatory
personnel.
Restructuring. Restructuring expenses decreased to approximately $0.3 million in 2006 from approximately
$1.0 million in 2005. Expenses for 2006 include exit activity costs of $0.2 million for our Phoenix, Arizona
facility, which closed in July 2006, and exit activity costs of $31,000 for our Brymbo, Wales facility, which
closed in December 2005. Expenses for 2005 include exit activity costs for our St. Petersburg, Florida, Brymbo,
Wales and Neuilly-en-Thelle, France facilities.
Impairment Charge. Impairment charges amounted to $0.1 million in 2006. We incurred no impairment
charge in 2005. The impairment charge of $0.1 million for 2006 resulted from the write-down of certain patents
and production equipment in connection with our decision to cease production and sales of our Expedial
Vascular Access Graft product line, net of the proceeds from the subsequent sale of those assets of $0.4 million.
We also wrote down $0.3 million of related inventory, which has been included in cost of sales.
Other income (expense). For 2006, interest income was $0.3 million compared to $4,000 in 2005. This was
largely a result of the increase in cash and marketable securities from the initial public offering completed on
October 19, 2006. Interest expense in 2006 increased by $0.1 million compared to 2005 due to an increase in our
outstanding line of credit and term notes payable for the period prior to the public offering. Gain on foreign
currency was due to a relative increase in the strength of the Euro as compared to the U.S. dollar, over the year.
Other income (expense) for 2006 was primarily due to losses on the disposal of fixed assets in 2006, while 2005
amounts were largely due to the foreign exchange gain of $0.6 million that we recognized as a result of the
dissolution of our French subsidiary.
Income tax expense. Our provision for income taxes in 2006 was $0.7 million compared to $0.5 million in
2005. The effective rate in 2006 was negative 125% as compared with 91.0% in 2005. The U.S. federal statutory
53
rate is 34.0%. The 2006 tax provision was a result of many factors, including the losses at one of our foreign
subsidiaries for which no tax benefit is recognizable, and the effects of permanent and discrete tax items related
to uncertain international tax positions. In addition, deferred tax liabilities related to the amortization of goodwill
for U.S. tax reporting purposes, may not be used to reduce existing deferred tax assets which requires higher
valuation allowances than otherwise needed. We monitor the mix of profitability by tax jurisdiction and adjust
our annual expected rate on a quarterly basis.
Comparison of the Year Ended December 31, 2005 to the Year Ended December 31, 2004
The following table sets forth, for the periods indicated, our results of operations and the change between
the specified periods expressed as percent increase or decrease:
2005
2004
Net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$30,727
8,927
$26,183
7,780
Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21,800
18,403
Operating expenses:
Sales and marketing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restructuring charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense):
Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign currency (loss) gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income before income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision for income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
10,960
6,405
3,015
998
422
4
(182)
(217)
551
578
523
55
Net Sales by Product Category:
Endovascular & Dialysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vascular
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Branded Sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Private Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 6,774
19,654
3,600
30,028
699
9,654
5,037
2,120
435
1,157
9
(137)
169
(57)
1,141
214
$
927
$ 3,340
18,233
3,682
25,255
928
$30,727
$26,183
Net Sales by Geography:
United States and Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Outside the United States and Canada . . . . . . . . . . . . . . . . . . . . .
$20,056
10,671
$17,689
8,494
$30,727
$26,183
Percent
change
17%
15%
18%
14%
27%
42%
129%
(64%)
(56%)
33%
NM
NM
(49%)
144%
(94%)
103%
8%
(2%)
19%
(25%)
17%
13%
26%
17%
Net sales. Net sales increased 17% to $30.7 million in 2005 as compared to $26.2 million in 2004. Sales
growth was primarily driven by growth of our products across all product lines and to a lesser degree our
acquisition of the EndoFit and UniFit Aortic Stent Graft product lines and related operations from Endomed, Inc.
in February 2005, and strong performance of the AnastoClip Vessel Closure System product line which we
acquired, together with the related operations, from Tyco Healthcare LP in February 2004. Sales growth was also
driven by higher average selling prices across nearly all product lines due to our stronger brand recognition and
54
customer loyalty, and our first full year of direct sales in Japan. Additionally, the increased adoption of
endovascular techniques by vascular surgeons benefited our VascuTape Radiopaque Tape and EndoFit and
UniFit Aortic Stent Graft product lines. Sales of our AnastoClip Vessel Closure System increased due to better
targeting of new customers and more effective surgeon training.
Net sales by geography. Net sales in the United States and Canada increased 13% to $20.1 million in 2005
as compared to $17.7 million in 2004. Net sales outside the United States and Canada increased 26% to
$10.7 million in 2005 as compared to $8.5 million in 2004, driven by the sales of our aortic stent graft product
lines, as well as by sales in Japan resulting from the opening of our Tokyo office in June 2004. Direct net sales
represented 59% of total net sales outside the United States and Canada in 2005 and increased by 16% over 2004.
Net sales to distributors represented 41% of the total net sales in 2005 outside the United States and Canada and
increased by 44% over 2004. This increase was primarily a result of our acquisition of the EndoFit and Unfit
Aortic Stent Graft product lines, substantially all of which we sold through distributors in 2005.
Gross Profit. Gross profit increased from $18.4 million in 2004 to $21.8 million in 2005, a 18% increase.
This gross margin increase was driven primarily by higher average selling prices and, to a lesser extent, reduced
cost of sales. Cost of sales decreased primarily due to our 2004 consolidation of our Neuilly-en-Thelle, France
manufacturing facility into our Burlington, Massachusetts headquarters, and the associated elimination of
overhead costs, partially offset by increased product build times resulting from this move. We also experienced
higher manufacturing costs related to our acquisition of the Endomed, Inc. At the acquisition date, Endomed
carried a lower gross margin than LeMaitre Vascular. We expect product build times to decrease at our
Burlington, Massachusetts facility as direct labor employees gain further experience manufacturing and
assembling products from our relocated factories.
Sales and marketing. Sales and marketing expense increased 14% to $11.0 million in 2005 as compared to
$9.7 million in 2004. Sales and marketing expense increased in 2005 primarily as a result of higher marketing
costs in Europe, the United States and Canada, and also as a result of increased compensation to our sales
representatives, partially offset by a reduced number of sales representatives. As of December 31, 2005, we
employed 30 bag-carrying sales representatives compared to 33 bag-carrying sales representatives as of
December 31, 2004.
General and administrative. General and administrative expense increased 27% to $6.4 million in 2005 as
compared to $5.0 million in 2004. General and administrative expense increased primarily as a result of expenses
relating to the EndoFit and UniFit Aortic Stent Graft product line, higher compensation expenses and higher
expenses from our Japanese subsidiary in its first full calendar year of operations. Those increases were partially
offset by $0.3 million of stock-based compensation charges in 2004 that did not recur in 2005.
Research and development. Research and development expense increased 42% to $3.0 million in 2005
compared to $2.1 million in 2004. Research and development expense increased primarily as a result of increased
clinical study costs in the United States, specifically relating to clinical trials for our EndoFit and UniFit Aortic
Stent Grafts and Expedial Vascular Access Graft product lines, increased testing expenses and increased royalty
payments relating to the EndoFit and UniFit Aortic Stent Graft and AnastoClip Vessel Closure System product
lines.
Restructuring. Restructuring charges increased to $1.0 million in 2005 compared to $0.4 million in 2004,
due to costs from the closing of our manufacturing plants in St. Petersburg, Florida and Wales, United Kingdom
in 2005, including a one-time payment of $0.5 million as consideration for the early termination of the lease of
the manufacturing facility in St. Petersburg, Florida.
Other income (expense). Other income (expense) increased to $0.2 million in 2005 as compared to a loss of
approximately $16,000 in 2004, due principally to favorable foreign currency translation adjustment income of
55
$0.6 million from the dissolution of our French foreign subsidiary. This gain was partially offset by foreign
currency losses from the weaker Euro in 2005.
Income tax expense. Our effective income tax rates were 91% in 2005 and 19% in 2004 compared to the
federal statutory rate of 34%. Our low effective rate in 2004 was attributable to the use of U.S. and German
net-operating loss and tax credit carryforwards to substantially reduce income tax liability in both tax
jurisdictions. In 2005, the rate exceeded the statutory rate due to unfavorable permanent items and the effect of
uncertain international tax positions.
Liquidity and Capital Resources
We require cash to pay our operating expenses, make capital expenditures and pay our long-term liabilities.
Since our inception, we have funded our operations through private placements of equity securities, short-term
borrowings and funds generated from our operations. In October 2006, we completed our initial public offering
of our common stock at a price to the public of $7.00 per share. We sold 5,500,000 shares of our common stock.
We received aggregate net proceeds of approximately $35.8 million, after deducting underwriting discounts and
commission of approximately $2.7 million. We incurred approximately $2.9 million for additional expenses
associated with our initial public offering.
At December 31, 2006, our cash and cash equivalents were $30.8 million as compared to $0.8 million at
December 31, 2005. Our cash and cash equivalents are highly liquid investments with maturity of 90 days or less
at date of purchase and consist of time deposits and investments in money market funds with commercial banks
and financial institutions and United States government obligations.
On October 24, 2006, we used $3.9 million of the net proceeds from the public offering to pay down all
outstanding indebtedness to Brown Brothers Harriman & Co., or Brown Brothers, under two term notes and a
revolving line of credit. As of December 31, 2006, we did not have any outstanding balances on the revolving
line of credit. We maintain a $5.5 million revolving line of credit with Brown Brothers as of December 31, 2006.
The revolving line of credit is collateralized by substantially all of our assets. In addition, we would be required
to meet certain financial and operating covenants including restrictions on incoming additional debt and any
borrowings under the loan would accrue interest at the bank’s rate. At December 31, 2006 and 2005, we were in
compliance with these covenants.
Net Cash Provided by (Used in) Operating Activities. Net cash used in operating activities was $0.5 million
in 2006. This was primarily a result of higher levels in accounts payable and other liabilities of $1.3 million and
non-cash charges of $1.8 million offset by a net loss of $1.2 million in 2006. There were also higher levels in
inventory and accounts receivable in 2006.
In 2005, net cash used was $1.2 million compared to net cash provided of $1.7 million in 2004. This
decrease was primarily caused by an increase in inventory, and a non cash foreign currency translation
adjustment of $0.6 million in 2005.
Net Cash Used in Investing Activities. Net cash used in investing activities was $16 million in 2006. This
was primarily due to the investment of $15.7 million of our proceeds from our initial public offering in
marketable securities.
Net cash used in investing activities was $1.4 million in 2005 compared to $2.9 million in 2004. For each of
these two periods, net cash used in investing activities reflected purchases of property, plant and equipment
primarily for the expansion of manufacturing operations, research and development, information technology and
capital improvements to our facilities. In addition, we acquired businesses, including intellectual property to
expand our product offerings.
Net Cash Provided by Financing Activities. Net cash provided by financing activities was $31.2 million in
2006. This was a result of our initial public offering, offset by offering expenses and our pay down of the long
term debt and line of credit.
56
Net cash provided by financing activities was $2.5 million in 2005 compared to $1.4 million in 2004. This
increase was primarily due to proceeds from issuance of common stock in private offerings and proceeds from
our borrowings on our line of credit.
We expect that our operating expenses will increase in absolute dollars in connection with the growth of our
business and our operations as a public company, including consulting expenses associated with compliance with
Section 404 of the Sarbanes-Oxley Act of 2002. We expect to fund these increased costs and expenditures from
our cash flows from operations and our existing cash and cash equivalents and marketable securities. However,
our future capital requirements depend on numerous forward-looking factors. These factors include, but are not
limited to, the following: the revenues generated by sales of our products; the costs associated with expanding
our manufacturing, marketing, sales and distribution efforts; the rate of progress and cost of our research and
development activities; patent litigation; the costs of obtaining and maintaining FDA and other regulatory
clearances of our products and products in development; the effects of competing technological and market
developments; the costs associated with being a public company, including consulting expenses associated with
compliance with Section 404 of the Sarbanes-Oxley Act of 2002 and the number and timing of acquisitions and
other strategic transactions.
We believe that our current cash and cash equivalents and marketable securities, and cash we expect to
generate from operations, will be sufficient to meet our anticipated cash needs for working capital and capital
expenditures for at least the next twelve months. However, we may require additional funds in order to further
develop the marketplace, make acquisitions, complete clinical studies and deliver new products to our customers.
We may seek financing of future cash needs through the sale of equity securities and debt. We cannot assure you
that additional financing will be available when needed or that, if available, such financing will be obtained on
terms favorable to us or our stockholders. Insufficient funds may require us to delay, scale back or eliminate
some or all of our business operations or may adversely affect our ability to operate as a going concern. If
additional funds are obtained by issuing equity or debt securities, substantial dilution to existing stockholders
may result.
Contractual Obligations. Our principal contractual obligations consist of inventory purchase commitments,
operating leases and capital leases. The following table summarizes our commitments to settle contractual
obligations as of December 31, 2006:
Contractual obligations
Total
Less than
1 year
Capital lease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchase commitments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
33
2,683
1,261
33
$
1,191
1,261
$3,977
$2,485
1-3 years
3-5 years
(in thousands)
$ —
1,267
—
$1,267
$—
215
—
$215
More than
5 years
$—
10
—
$ 10
The commitments under our operating leases shown above consist primarily of lease payments for our
Burlington, Massachusetts corporate headquarters and manufacturing facility and a separate manufacturing and
storage facility in Burlington, Massachusetts, each expiring in 2008, our Sulzbach, Germany office, expiring in
2010, and our Tokyo, Japan office, expiring in 2007.
The capital lease obligations consist of capital leases for a variety of equipment.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as of December 31, 2006.
Critical Accounting Policies and Estimates
We have adopted various accounting policies to prepare our consolidated financial statements in accordance
with U.S. generally accepted accounting principals, or U.S. GAAP. Our most significant accounting policies are
57
described in note 1 to our consolidated financial statements included elsewhere in this Annual Report on
Form 10-K. The preparation of our consolidated financial statements in conformity with U.S. GAAP requires us
to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and
accompanying notes. Our estimates and assumptions, including those related to bad debts, inventories, intangible
assets, sales returns and discounts, and income taxes are updated as appropriate.
Certain of our more critical accounting policies require the application of significant judgment by
management in selecting the appropriate assumptions for calculating financial estimates. By their nature, these
judgments are subject to an inherent degree of uncertainty. These judgments are based on our historical
experience, terms of existing contracts, observance of trends in the industry, and information provided by
physicians who use our products and information available from other outside sources, as appropriate. Different,
reasonable estimates could have been used in the current period. Additionally, changes in accounting estimates
are reasonably likely to occur from period to period. Both of these factors could have a material impact on the
presentation of our financial condition, changes in financial condition or results of operations.
We believe that the following financial estimates are both important to the portrayal of our financial
condition and results of operations and require subjective or complex judgments. Further, we believe that the
items discussed below are properly recorded in our consolidated financial statements for all periods presented.
Management has discussed the development, selection and disclosure of our most critical financial estimates with
the audit committee of our board of directors and our independent registered public accounting firm. The
judgments about those financial estimates are based on information available as of the date of our consolidated
financial statements. Those financial estimates include:
Revenue Recognition
We recognize revenue in accordance with SEC Staff Accounting Bulletin, or SAB, No. 104, Revenue
Recognition. SAB No. 104 requires that four basic criteria must be met before revenue can be recognized:
(1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered;
(3) the fee is fixed or determinable; and (4) collectibility is reasonably assured. We generally use customer
purchase orders or contracts to determine the existence of an arrangement. We use shipping documents and third-
party proof of delivery to verify that title has transferred. We assess whether the fee is fixed or determinable
based on the terms of the agreement associated with the transaction. In order to determine whether collection is
probable, we assess a number of factors, including past transaction history with the customer and the
creditworthiness of the customer. If we determine that collection is not reasonably assured, we would defer the
recognition of revenue until collection becomes reasonably assured, which is generally upon receipt of payment.
We account for product returns in accordance with Statement of Financial Accounting Standards, or
SFAS, No. 48, Revenue Recognition When Right of Return Exists, providing for returns based on our historical
return product history.
Accounts Receivable
Accounts receivable are generally due within 30 to 60 days of invoice and are stated at amounts due from
customers, net of an allowance for doubtful accounts and sales returns. We perform ongoing customer credit
evaluations and adjust credit limits based upon payment history and the customer’s current creditworthiness, as
determined by a review of their current credit information. We continuously monitor aging reports, collections
and payments from customers, and maintain a provision for estimated credit losses based upon historical
experience and any specific customer collection issues we identify. While such credit losses have historically
been within our expectations and allowances, we cannot guarantee the same credit loss rates will be experienced
in the future. We write off accounts receivable when they become uncollectible.
Inventory
We value inventory at the lower of cost (on the first-in, first-out method) or market. On a quarterly basis, we
review inventory quantities on hand and analyze the provision for excess and obsolete inventory based primarily
58
on product expiration dating and our estimated sales forecast, which is based on sales history and anticipated
future demand. Our estimates of future product demand may not be accurate, and we may understate or overstate
the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in
demand could have a significant impact on the value of our inventory and results of operations. As of
December 31, 2006 and 2005, our reserve for excess and obsolete inventory was $0.3 million and $0.4 million,
respectively.
Stock-Based Compensation
Through December 31, 2005, we measured employee stock-based compensation expense using the intrinsic
value-based method of accounting prescribed by Accounting Principles Board, or APB, Opinion No. 25,
Accounting for Stock Issued to Employees, Financial Accounting Standards Board, or FASB, Interpretation No.,
or FIN, 44, Accounting for Certain Transactions Involving Stock Compensation, and related interpretations. For
stock options granted to employees, no compensation expense is recognized unless the exercise price is less than
the estimated fair value, for financial reporting purposes.
Until January 1, 2006, we complied with the disclosure requirements of SFAS No. 123, Accounting for
Stock-Based Compensation, as amended by SFAS No. 148, Accounting for Stock-Based Compensation—
Transition and Disclosure—an amendment of FASB Statement No. 123, which required that we disclose our pro
forma net income or loss and net income or loss per common share as if we had expensed the fair value of
employee stock options. For purposes of this pro forma disclosure, we estimated the fair value of stock options
issued to employees using the minimum value valuation option-pricing model. Our minimum value valuation
option-pricing model required the input of highly subjective assumptions, including the expected life of these
options and our expected stock price volatility. Therefore, the estimated fair value of our employee stock options
could vary significantly as a result of changes in the assumptions used. Our use of the minimum value model was
primarily due to our determination as to its appropriateness as well as its general acceptance as an option
valuation technique for private companies. As described below, we no longer utilize the minimum value method
subsequent to January 1, 2006, and the fair value of our options will be higher as a result.
Through December 31, 2006, we accounted for stock-based compensation expense for non-employees using
the fair value method prescribed by SFAS No. 123 and the Black-Scholes option-pricing model, and record the
fair value, for financial reporting purposes, of non-employee stock options as an expense over either the vesting
term of the option or the service period.
In December 2004, FASB issued SFAS No. 123R, Share-Based Payment, which requires companies to
expense the fair value of employee stock options and other forms of share-based compensation. Effective
January 1, 2006, we adopted SFAS No. 123R. SFAS No. 123R requires nonpublic companies that used the
minimum value method in SFAS No. 123 for either recognition or pro forma disclosures to apply
SFAS No. 123R using the prospective-transition method. As such, we will continue to apply APB 25 in future
periods to equity awards outstanding at the date of SFAS No. 123R’s adoption that were measured using the
minimum value method. In accordance with this standard, the prior period pro forma stock information has not
been restated. In accordance with SFAS No. 123R, we will recognize the compensation cost of share-based
awards on a straight-line basis over the vesting period of the award. For the year ended December 31, 2006, we
recorded expense of approximately $0.4 million in connection with share-based payment awards. The future
expense of non-vested options of approximately $1.3 million is to be recognized through 2011.
In 1997, we issued to two of our executive officers stock options for the purchase of an aggregate of
386,272 shares and to one of these executive officers an award of an additional 252,852 shares of our common
stock. The options and award were subject to restricted stock agreements that provided us the right to purchase,
and the executive officers with the right to cause us to purchase, these shares. The purchase right features of
these agreements terminated upon the completion of our initial public offering in October 2006. We accounted
for these options and award until 1998 using variable plan accounting since the exercise of the employee
repurchase
59
price was considered likely based on the lack of marketability of our common stock. After reviewing a variety of
factors, we subsequently determined that the likelihood of either us or these executive officers exercising these
purchase options was remote. Consequently, subsequent to 1998 we have accounted for these options and award
using fixed plan accounting. See the notes to our consolidated financial statements included elsewhere in this
Annual Report on Form 10-K.
Upon adoption of SFAS No. 123R, based on the use of the prospective method of adoption, these options
and this award will continue to be accounted for under APB No. 25 as fixed plan arrangements. Concurrently
with the adoption of SFAS No. 123R, we applied the guidance included in Accounting Series Release No. 268
and Emerging Issues Task Force No. D-98 with respect to the redemption feature related to these options and
award. The effect of the adoption resulted in the classification of the intrinsic value of the redemption feature of
$6.5 million at January 1, 2006 from retained earnings to other than permanent equity. During 2006, the value of
the redemption feature increased by $0.3 million to $6.8 million, which was charged against retained earnings.
The repurchase and call right features terminated upon the completion of our public offering of our common
stock resulting in a $6.8 million credit to additional paid-in capital.
Prior to our initial public offering there was no public market for our common stock, and in connection with
our issuance of stock options the fair value for our common stock was estimated by our board of directors, with
input from management. Our board of directors exercised judgment in determining the estimated fair value of our
common stock on the date of grant based on several factors, including transactions in our common stock, key
milestones achieved in our business, and both historical and forecasted net sales. In the absence of a
contemporaneous arms-length transaction, our board typically estimated the fair value of our common stock
based upon an enterprise valuation determined by multiplying our trailing six months of net sales by two, and
then multiplying that amount by four. We believed this to be a reasonable methodology based upon our internal
peer company analyses and based on several arms-length transactions involving our common stock supportive of
the results produced by this valuation methodology. We have not historically obtained contemporaneous
valuations by an unrelated valuation specialist because, at the time of the issuances of stock options, we believed
our estimates of the fair value of our common stock to be reasonable and consistent with our understanding of
how similarly situated companies in our industry are valued.
As disclosed more fully in the notes of our financial statements, during 2006 we granted stock options with
exercise prices ranging from $5.95 to $12.37 and restricted stock units with prices of $6.07.
In connection with the preparation of our financial statements for the year ended December 31, 2005 and in
preparing for the initial public offering of our common stock, we reassessed the valuations of our common stock
during the twelve-month period ended March 31, 2006, in light of the AICPA’s Practice Aid Valuation of
Privately-Held-Company Equity Securities Issued as Compensation, which we refer to as the practice aid. In
conducting this assessment we took into consideration the market and income approaches to valuation as set forth
in the practice aid. We believe that the valuation methodologies that we used prior to this public offering are
consistent with the practice aid. Based on the foregoing analysis, we concluded that for all options granted during
the twelve-month period ended March 31, 2006, in no case did the fair value of our common stock, for financial
reporting purposes, exceed the exercise price for these options at the time of grant.
Valuation of Goodwill, Other Intangibles
When we acquire another company, the purchase price is allocated, as applicable, among acquired tangible
net assets, identifiable intangible assets, and goodwill as required by U.S. GAAP. Goodwill represents the excess
of the aggregate purchase price over the fair value of net assets of the acquired businesses. Goodwill is tested for
impairment annually or more frequently if changes in circumstance or the occurrence of events suggest
impairment exists. We evaluate the carrying value of our goodwill annually in our fourth quarter based on a
single reporting unit. The first step of our goodwill impairment test, used to identify potential impairment,
compares the fair value of our reporting unit with its carrying amount, including goodwill. If the fair value of our
60
reporting unit exceeds its carrying amount, the goodwill of the reporting unit is considered not impaired, and thus
the second step of the impairment test, used to measure the amount of the impairment loss, is unnecessary. If the
carrying amount of our reporting unit exceeds its fair value, the second step of the goodwill impairment test is
performed to measure the amount of impairment loss, if any. The second step of the goodwill impairment test,
used to measure the amount of impairment loss, compares the implied fair value of the reporting unit goodwill as
of the date of the impairment review with the carrying amount of that goodwill. The implied fair value of our
goodwill is determined on the same basis as the amount of goodwill recognized in connection with a business
combination. Specifically, we allocate the fair value of our reporting unit to all of the assets and liabilities of that
unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business
combination as of the date of the impairment review and as if the fair value of the reporting unit was the price
paid to acquire the reporting unit. The excess of the fair value of a reporting unit over the amounts assigned to its
assets and liabilities is the implied fair value of goodwill. If the carrying amount of the reporting unit goodwill
exceeds the implied fair value of that goodwill, an impairment loss shall be recognized in an amount equal to that
excess. We have determined that no impairment charges were required during the year ended December 31,
2006. The test for impairment requires us to make several estimates about fair value, principally related to the
determination that we operate as a single unit and therefore that fair value is based on our market capitalization.
Our estimates associated with the goodwill impairment tests are considered critical due to the amount of goodwill
recorded on our combined consolidated balance sheets and the judgment required in determining fair value
amounts. Goodwill was $8.9 million at December 31, 2006 and 2005, respectively.
Other intangible assets consist primarily of purchased developed technology, patents, customer relationships
and trademarks and are amortized over their estimated useful lives, ranging from five to 17 years. We review
these intangible assets for impairment as changes in circumstance or the occurrence of events suggest the
remaining value may not be recoverable. Other intangible assets, net of accumulated amortization, were
$1.9 million and $2.4 million at December 31, 2006 and 2005, respectively.
The evaluation of asset impairments related to other intangible assets require us to make assumptions about
future cash flows over the life of the asset being evaluated. These assumptions require significant judgment and
actual results may differ from assumed or estimated amounts.
Contingencies
We are subject to proceedings, lawsuits and other claims. We assess the likelihood of any adverse
judgments or outcomes to these matters as well as potential ranges of probable losses. A determination of the
amount of reserves required, if any, for these contingencies is made after careful analysis of each individual
issue. The required reserves may change in the future due to new developments in each matter or changes in
approach such as a change in settlement strategy in dealing with these matters. We record charges for the costs
we anticipate incurring in connection with litigation and claims against us when we can reasonably estimate these
costs.
Restructuring
We record restructuring charges incurred in connection with consolidation or relocation of operations,
exited business lines, or shutdowns of specific sites. These restructuring charges, which reflect our commitment
to a termination or exit plan that will begin within twelve months, are based on estimates of the expected costs
associated with site closure, legal matters, contract terminations, or other costs directly related to the
restructuring. If the actual cost incurred exceeds the estimated cost, an additional charge to earnings will result. If
the actual cost is less than the estimated cost, a credit to earnings will be recognized.
Accounting for Income Taxes
As part of the process of preparing our combined consolidated financial statements we are required to
determine our income taxes in each of the jurisdictions in which we operate. This process involves estimating our
61
actual current tax expense together with assessing temporary differences resulting from recognition of items for
income tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are
included within our combined consolidated balance sheet. We must then assess the likelihood that our deferred
tax assets will be recovered from future taxable income and, to the extent we believe that recovery is not likely,
we must establish a valuation allowance. To the extent we establish a valuation allowance or increase this
allowance in a period, we must reflect this increase as an expense within the tax provision in the statement of
operations.
We do not provide for income taxes on undistributed earnings of foreign subsidiaries, as our current
intention is to permanently reinvest these earnings.
Management’s judgment is required in determining our provision for income taxes, our deferred tax assets
and liabilities and any valuation allowance recorded against our net deferred tax assets. We will continue to
monitor the realizability of our deferred tax assets and adjust the valuation allowance accordingly. We have
recorded a valuation allowance on our net deferred tax assets of $1.1 million and $1.0 million as of December 31,
2006 and 2005, respectively.
Off-Balance Sheet Arrangements
We do not currently have, nor have we ever had, any relationships with unconsolidated entities or financial
partnerships, such as entities often referred to as structured finance or special purpose entities, which would have
been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or
limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts. As
a result, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had
engaged in these relationships.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
We are exposed to various market risks arising from adverse changes in market rates and prices, such as
foreign exchange fluctuations and interest rates, which could impact our results of operations and financial
position. We do not currently engage in any hedging or other market risk management tools, and we do not enter
into derivatives or other financial instruments for trading or speculative purposes.
Foreign Currency Exchange Rate Risk. Fluctuations in the rate of exchange between the U.S. dollar and
foreign currencies, primarily the Euro, could adversely affect our financial results. For the year ended
December 31, 2006, approximately 35% of our sales were denominated in foreign currencies. We expect that
foreign currencies will continue to represent a similarly significant percentage of our sales in the future. Selling,
marketing and administrative costs related to these sales are largely denominated in the same respective currency,
thereby mitigating our transaction risk exposure. We therefore believe that the risk of a significant impact on our
operating income from foreign currency fluctuations is not substantial. However, for sales not denominated in
U.S. dollars, if there is an increase in the rate at which a foreign currency is exchanged for U.S. dollars, it will
require more of the foreign currency to equal a specified amount of U.S. dollars than before the rate increase. In
such cases and if we price our products in the foreign currency, we will receive less in U.S. dollars than we did
before the rate increase went into effect. If we price our products in U.S. dollars and competitors price their
products in local currency, an increase in the relative strength of the U.S. dollar could result in our price not
being competitive in a market where business is transacted in the local currency.
The majority of sales recorded in foreign currencies for the year are denominated in the Euro. Our principal
exchange rate risk therefore exists between the U.S. dollar and the Euro. Fluctuations from the beginning to the
end of any given reporting period result in the re-measurement of our foreign currency-denominated receivables
and payables, generating currency transaction gains or losses that impact our non-operating income/expense
levels in the respective period and are reported in other (income) expense, net in our combined consolidated
62
financial statements. We recorded a $0.2 million foreign currency gain in 2006 and $0.2 million foreign currency
loss in 2005 related mainly to the re-measurement of our foreign currency-denominated receivables and
payables. We do not currently hedge our exposure to foreign currency exchange rate fluctuations. We may,
however, hedge such exposure to foreign currency exchange rate fluctuations in the future.
Interest Rate Risk. Our exposure to interest rate risk at December 31, 2006 is related primarily to our
investment portfolio. Our investment portfolio includes fixed rate debt instruments of high quality US
government and corporate issuers. A change in prevailing interest rates may cause the fair value of our
investments to fluctuate. For example, if we hold a security that was issued with a fixed interest rate at the then-
prevailing rate and the prevailing rate rises, the fair value of the principal amount of our investment will probably
decline. To minimize this risk, investments are generally held to maturity and the weighted average duration of
our investments is 15 months or less. Due to the short-term nature of these investments, we believe we have no
material exposure to interest rate risk arising from our investments.
Recent Accounting Pronouncements
In June 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Correction, a replacement of
APB No. 20, Accounting Changes, and SFAS No. 3, Reporting Accounting Changes. SFAS No. 154 changes the
requirements related to accounting for and reporting of a change in accounting principle. This Statement applies
to all voluntary changes in accounting principle and changes required by a new accounting pronouncement, in the
unusual instance that the pronouncement does not include specific transition provisions. SFAS No. 154 requires
retrospective application to prior periods’ financial statements of changes in accounting principle versus the
previous guidance which allowed the recording of the impact of an accounting change in the current period’s net
income as a cumulative effect adjustment. This Statement is effective for us beginning in fiscal year 2007.
Adoption is not expected to have a material impact on our consolidated financial condition or results of
operations.
In July 2006, the FASB issued Financial Accounting Standards Interpretation No. 48, Accounting for
Uncertainty in Income Taxes, or FIN 48. FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in an enterprises’ financial statements in accordance with SFAS No. 109. FIN 48 prescribes a
recognition and measurement method of a tax position taken or expected to be taken in a tax return. FIN 48 also
provides guidance on derecognition, classification, interest and penalties, accounting in interim periods,
disclosures and transitions. FIN 48 is effective for fiscal years beginning after December 15, 2006 and will be
adopted in our quarterly period ending March 31, 2007. We are currently analyzing the expected effects of
FIN 48 on our consolidated financial position and our results of operations.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, which defines fair value,
establishes a framework for measuring fair value, and expands disclosures about fair value measurements. Where
applicable, this Statement simplifies and codifies related guidance within generally accepted accounting
principles (GAAP). This statement is effective for financial statements issued for fiscal years beginning after
November 15, 2007, and interim periods within those fiscal years. We are currently analyzing the expected
impact from adopting this statement on its financial statements, but currently does not believe its adoption will
have a significant impact on our consolidated financial position or results of operations.
Item 8.
Financial Statements and Supplementary Data
See the consolidated financial statements filed as part of this Annual Report on Form 10-K as listed under
Item 15 below.
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not Applicable.
63
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be
disclosed by us in reports we file or submit under the Securities and Exchange Act of 1934 is reported, processed,
summarized and reported within the time periods specified in the SEC’s rules and forms. As of December 31,
2006 (the “Evaluation Date”), our management, with the participation of our Chief Executive Officer and Chief
Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934). Based upon that evaluation, our Chief
Executive Officer and Chief Financial Officer concluded that, as of the Evaluation Date, our disclosure controls
and procedures were effective at the reasonable assurance level. Our management recognizes that any controls
and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving
their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of
possible controls and procedures.
Internal Control over Financial Reporting
This Annual Report on Form 10-K does not include a report of management’s assessment regarding internal
control over financial reporting or an attestation report of our registered public accounting firm due to a transition
period established by rules of the Securities and Exchange Commission for newly public companies. There have
been no changes in our internal control over financial reporting for the quarter ended December 31, 2006 that
have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
Item 9B. Other Information
None.
64
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this item concerning our directors and executive officers is incorporated by
reference herein from the information to be contained in our definitive proxy statement (the “2007 Definitive
Proxy Statement”) for the 2007 annual meeting of stockholders to be filed with the Securities and Exchange
Commission within 120 days after the year ended December 31, 2006.
The information required by this item concerning compliance with Section 16(a) of the Exchange Act is
incorporated herein by reference from the information contained in our 2007 Definitive Proxy Statement.
Code of Ethics
Certain documents relating to our corporate governance, including our Code of Business Conduct and
Ethics, which is applicable to our directors, officers and employees, and the charters of the Audit Committee,
Compensation Committee and Corporate Governance and Nominating Committee of our Board of Directors, are
available on our website at http://www.lemaitre.com. We intend to disclose substantive amendments to or
waivers (including implicit waivers) of any provision of the Code of Business Conduct and Ethics that apply to
our principal executive officer, principal financial officer, principal accounting officer or controller, or persons
performing similar functions, by posting such information on our website available at http://www.lemaitre.com.
Item 11. Executive Compensation
The information required by this item concerning executive compensation is incorporated herein by
reference from the information to be contained in our 2007 Definitive Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
The information required by this item concerning security ownership of certain beneficial owners and
management is incorporated herein by reference from the information to be contained in our 2007 Definitive
Proxy Statement.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item concerning certain relationships and related transactions, and director
independence is incorporated herein by reference from the information to be contained in our 2007 Definitive
Proxy Statement.
Item 14. Principal Accounting Fees and Services
The information required by this item concerning principal accounting fees and services is incorporated
herein by reference from the information to be contained in our 2007 Definitive Proxy Statement.
65
PART IV
Item 15. Exhibits, Financial Statement Schedules and Reports on Form 8-K
a) Documents filed as part of this Report.
(1) The following consolidated financial statements are filed herewith in Item 8 of Part II above.
(i) Report of Independent Registered Public Accounting Firm
(ii) Consolidated Balance Sheets
(iii) Consolidated Statements of Operations
(iv) Consolidated Statements of Changes in Stockholders’ Equity and Comprehensive Income (Loss)
(v) Consolidated Statements of Cash Flows
(vi) Notes to Consolidated Financial Statements
(2) Financial Statement Schedules
Schedule II – Valuation and Qualifying Accounts. Such schedule should be read in conjunction with
the consolidated financial statements. All other supplemental schedules are omitted because of the
absence of conditions under which they are required.
(3) Exhibits
Exhibit
Number
2.1(1)
2.2(1)
Description
Asset Purchase Agreement by and between LeMaitre Acquisition, LLC and Endomed, Inc. dated
February 2, 2005
Shareholder Debt Transfer Agreement by and between LeMaitre Acquisition, LLC and the
shareholders of Endomed, Inc. named therein dated February 2, 2005
3.1(1)
Amended and Restated By-laws of the Registrant
3.2(1)
Form of Amended and Restated Certificate of Incorporation of the Registrant
3.3(1)
Form of Second Amended and Restated Certificate of Incorporation of the Registrant (to be effective
upon completion of the offering)
4.1(1)
Specimen Certificate evidencing shares of common stock
10.1(1)
10.2(1)
Northwest Park Lease dated March 31, 2003 by and between the Registrant and Roger P. Nordblom
and Peter C. Nordblom, as Trustees of Northwest Associates, as amended
Registration Rights Agreement dated June 17, 1998 by and between the Registrant and Housatonic
Equity Investors, L.P.
10.3#(1) Patent Sublicense Agreement dated March 7, 2003 by and between IMPRA, Inc. and Endomed, Inc.
10.4#(1) Confirmation and Agreement dated February 2, 2005 by and between the Registrant and Bard
Peripheral Vascular, Inc.
10.5#(1) License Agreement dated February 11, 1992 by and between United States Surgical Corporation and
Spinnaker R&D Associates, as amended
10.6#(1) Side Letter Agreement dated January 30, 2004 by and between the Registrant and Spinnaker R&D
Associates
66
Exhibit
Number
10.7†(1)
10.8†(1)
Description
Executive Retention and Severance Agreement dated October 10, 2005 by and between the
Registrant and George W. LeMaitre
Executive Service Agreement dated September 17, 2003 by and between the Registrant and Peter
Gebauer, as amended
10.9†(1)
Employment Agreement dated May 27, 2005 by and between the Registrant and Kevin Kelly
10.10†(1) Employment Agreement dated April 20, 2006 by and between the Registrant and Joseph P.
Pellegrino (corrected)
10.11†(1)
1997 Stock Option Plan and form of agreements thereunder
10.12†(1)
1998 Stock Option Plan and form of agreements thereunder
10.13†(1)
2000 Stock Option Plan and form of agreements thereunder
10.14†(1)
2004 Stock Option Plan and form of agreements thereunder
10.15†(1)
2006 Stock Option and Incentive Plan and form of agreements thereunder
10.16†(1)
2006 Employee Stock Purchase Plan
10.17(1)
Form of Indemnification Agreement between the Registrant and its directors and executive officers
10.18(1)
10.19(1)
10.22(1)
Third Amended and Restated Revolving Loan and Security Agreement dated May 20, 2006 between
the Registrant and Brown Brothers Harriman & Co.
Second Amended and Restated Promissory Note (Secured) in favor of Brown Brothers Harriman &
Co. dated May 20, 2006
Guaranty of Vascutech Acquisition LLC in favor of Brown Brothers Harriman & Co. dated March
29, 2001, as amended
10.24(1)
Employment Agreement dated June 20, 2006 by and between the Registrant and David Roberts
10.25†(1) Management Incentive Compensation Plan (2006)
10.26(1)
Letter Agreement with Brown Brothers Harriman & Co. dated September 25, 2006.
10.28(1)
10.29(1)
Amendment to Guaranty of Vascutech Acquisition LLC in favor of Brown Brothers Harriman & Co.
dated September 25, 2006
Security Agreement of Vascutech Acquisition LLC in favor of Brown Brothers Harriman & Co.
dated March 29, 2001, as amended
21.1**
List of Subsidiaries
23.2**
Consent of Ernst & Young LLP
31.1**
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2**
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
(1) Previously filed as an exhibit to Registration Statement No. 333-133532 and incorporated herein by
reference.
Indicates a management contract or any compensatory plan, contract or arrangement.
†
** Filed herewith
67
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on March 30,
2007.
LEMAITRE VASCULAR
By:
/s/ GEORGE W. LEMAITRE
George W. LeMaitre, President,
Chief Executive Officer and Chairman of the Board
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by
the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ GEORGE W. LEMAITRE
President, Chief Executive Officer,
March 30, 2007
George W. LeMaitre
and Chairman of the Board
Principal Executive Officer
/s/ DAVID B. ROBERTS
Chief Financial Officer and
March 30, 2007
David B. Roberts
Director
/s/ GEORGE D. LEMAITRE, M.D.
Director
March 30, 2007
George D. LeMaitre, M.D.
/s/ CORNELIA W. LEMAITRE
Vice President, Human Resources
March 30, 2007
Cornelia W. LeMaitre,
and Director
/s/ LAWRENCE J. JASINSKI
Director
March 30, 2007
Lawrence J. Jasinski
/s/ MICHAEL C. JACKSON
Director
March 30, 2007
Michael C. Jackson
/s/ DAVID N. GILL
David N. Gill
Director
March 30, 2007
/s/ DUANE M. DESISTO
Director
March 30, 2007
Duane M. DeSisto
/s/ GUIDO J. NEELS
Guido J. Neels
Director
March 30, 2007
68
INDEX TO FINANCIAL STATEMENTS
LeMaitre Vascular, Inc.
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Balance Sheets as of December 31, 2006 and 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Operations for the Years Ended December 31, 2006, 2005 and 2004 . . . . . . . .
Consolidated Statements of Stockholders’ Equity and Comprehensive Income (Loss) for the Years Ended
December 31, 2006, 2005 and 2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Cash Flows for the Years Ended December 31, 2006, 2005 and 2004 . . . . . . . .
Notes to Consolidated Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Page
F-2
F-3
F-4
F-5
F-8
F-9
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of LeMaitre Vascular, Inc.
We have audited the accompanying consolidated balance sheets of LeMaitre Vascular, Inc. (the
“Company”) as of December 31, 2006 and 2005, and the related consolidated statements of operations,
shareholders’ equity, and cash flows for each of the three years in the period ended December 31, 2006. Our
audit also included the 2006 financial statement schedule listed at item 15(a)2. These financial statements and
schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on
these financial statements and schedule based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements are free of material misstatement. We were not engaged to perform an
audit of the Company’s internal control over financial reporting. Our audits included consideration of internal
control over financial reporting as a basis for designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on
a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting
principles used and significant estimates made by management, and evaluating the overall financial statement
presentation. We believe that our audit provides a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects,
the consolidated financial position of LeMaitre Vascular, Inc. at December 31, 2006 and 2005, and the
consolidated results of its operations and its cash flows for each of the three years in the period ended
December 31, 2006, in conformity with U.S. generally accepted accounting principles. Also, in our opinion, the
related 2006 financial statement schedule, when considered in relation to the basic financial statements taken as a
whole, presents fairly in all material respects, the information set forth therein.
As discussed in Note 1 to the consolidated financial statements, effective January 1, 2006, the Company adopted
Statement of Financial Accounting Standards No. 123R, “Share-Based Payment.”
Boston, Massachusetts
February 20, 2007
/s/ Ernst & Young LLP
F-2
LeMaitre Vascular, Inc.
Consolidated Balance Sheets
December 31,
2006
2005
(in thousands, except
share data)
Assets
Current assets:
Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Marketable securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts receivable, net of allowances of $102 in 2006 and $120 in 2005 . . . . . . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred tax asset
$15,391
15,417
5,060
6,081
1,296
396
$
817
—
4,207
5,147
486
160
Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
43,641
10,817
Property and equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill
Other intangibles, net
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2,389
8,853
1,930
150
2,658
8,853
2,412
328
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$56,963
$25,068
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revolving line of credit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current portion of capital lease obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current maturities of long-term debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Long-term debt, net of current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Capital lease obligations, net of current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred tax liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long-term liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
818
4,528
—
32
—
5,378
—
—
833
53
$
265
3,598
710
90
432
5,095
648
29
604
156
Total liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6,264
6,532
Stockholders’ equity:
Preferred stock, $0.01 par value; 5,000,000 shares authorized in 2006 and 1,500,000
shares authorized, 74,353 shares designated as Series A convertible, 63,731 shares
issued and outstanding in 2005 (liquidation preference $5,364)
. . . . . . . . . . . . . . . . .
Common stock, $0.01 par value; 100,000,000 shares authorized, 15,332,526 shares
issued in 2006, 15,000,000 shares authorized and 8,560,233 shares issued in
2005.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional paid-in capital
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated deficit
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated other comprehensive income (loss)
Treasury stock (14,068 shares in 2006 and 77,975 shares in 2005), at cost . . . . . . . . . . .
—
2,191
153
60,504
—
(9,946)
73
(85)
86
19,198
(84)
(2,005)
(67)
(783)
Total stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
50,699
18,536
Total liabilities and stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$56,963
$25,068
See accompanying notes to consolidated financial statements.
F-3
LeMaitre Vascular, Inc.
Consolidated Statements of Operations
Year ended December 31,
2006
2005
2004
Net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(in thousands,
except per share data)
$30,727
8,927
$26,183
7,780
$34,628
9,367
Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25,261
21,800
18,403
Sales and marketing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restructuring charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15,183
7,105
3,301
257
94
10,960
6,405
3,015
998
—
9,654
5,037
2,120
435
—
Total operating expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25,940
21,378
17,246
Income (loss) from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense):
(679)
422
1,157
Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign currency gain (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense), net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign currency translation adjustment due to dissolution of French
subsidiary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) before income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision for income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
299
(296)
228
(72)
—
(520)
652
Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ (1,172) $
4
(182)
(217)
(33)
584
578
523
55
Net income (loss) available for common shareholders:
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ (0.15) $
0.01
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ (0.15) $
0.01
9
(137)
169
(57)
—
1,141
214
927
0.10
0.10
$
$
$
Weighted-average shares outstanding:
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9,904
9,904
8,246
8,701
7,941
8,354
See accompanying notes to consolidated financial statements.
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F-7
LeMaitre Vascular, Inc.
Consolidated Statements of Cash Flows
Operating activities
Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities:
Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Impairment charges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision for deferred income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign currency translation adjustment from dissolution of French subsidiary . . . . . . . . . . . . . . .
Loss on disposal of property and equipment
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes in operating assets and liabilities, net of effect of business acquisitions:
Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable and other liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Year ended December 31,
2006
2005
2004
(in thousands)
$ (1,172) $
55
$
927
1,308
404
94
(6)
—
83
(689)
(780)
(1,031)
1,280
1,208
33
—
182
(584)
45
(388)
(1,769)
(97)
113
967
303
—
28
—
157
(727)
167
(152)
12
Net cash provided by (used in) operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(526)
(1,202)
1,682
Investing activities
Purchase of property and equipment
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash paid for business acquisitions, net of cash acquired . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sale of property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sale of impaired assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchase of technology license . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sale (purchase) of marketable securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchase of available for sale securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maturities of available for sale securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(969)
—
34
323
—
—
(15,689)
295
76
(1,013)
(1,379)
487
—
—
300
—
—
223
(988)
(500)
—
—
(575)
(300)
—
—
(544)
Net cash used in investing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(15,930)
(1,382)
(2,907)
Financing activities
Net proceeds from issuance of common stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from initial public offering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds/(repayment) under revolving line of credit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from long-term debt
Principal payments on long-term debt
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Principal payments on capital lease obligations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Collection of subscription receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expenses associated with equity transactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchase of treasury stock, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Effect of exchange rate changes on cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net increase (decrease) in cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash and cash equivalents at beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
47
35,805
(710)
2,500
(3,580)
(87)
—
(2,661)
(159)
31,171
(142)
14,574
817
Cash and cash equivalents at end of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 15,391
Supplemental information
Cash paid for income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash paid for interest
Supplemental non-cash financing activities
Issuance of common stock for subscription receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Common stock issued in connection with acquisitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reclassification of stock option obligation to additional paid-in capital . . . . . . . . . . . . . . . . . . . . . . . . .
Reclassification of deferred compensation upon adoption of SFAS No. 123R . . . . . . . . . . . . . . . . . . . .
Effect of adoption of SFAS 123R for redemption feature of common stock awards . . . . . . . . . . . . . . .
Increase in redemption feature of common stock awards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cancellation of redemption feature as a result of the initial public offering . . . . . . . . . . . . . . . . . . . . . .
Initial public offering costs included in accounts payable and accrued expenses . . . . . . . . . . . . . . . . . .
Cancellation of Treasury Stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
$
249
307
—
—
84
6,474
295
6,769
271
857
3,115
—
710
—
(432)
(347)
48
(45)
(561)
2,488
189
93
724
817
3
184
2,000
—
—
—
—
—
—
$
$
$
2,216
—
—
—
(522)
(241)
91
(102)
(84)
1,358
32
165
559
724
36
132
50
200
1,039
—
—
—
—
—
$
$
$
See accompanying notes to consolidated financial statements.
F-8
LeMaitre Vascular, Inc.
Notes to Consolidated Financial Statements
December 31, 2006
1. Significant Accounting Policies and Related Matters
Description of Business
LeMaitre Vascular, Inc. (“LeMaitre Vascular” or the “Company”) and its subsidiaries develop, manufacture
and market medical devices used primarily in the field of vascular surgery. The Company operates in a single
segment in which its principal product lines are stent grafts, anastomotic clips, radiopaque tape, valvulotomes,
carotid shunts, balloon catheters, vein strippers, cholangiogram catheters and vascular access ports.
Consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned
subsidiaries, LeMaitre Vascular GmbH, LeMaitre Vascular KK, LeMaitre UK Acquisition LLC, Vascutech
Acquisition LLC, LeMaitre Acquisition LLC, LeMaitre Vascular Limited, dissolved in 2006, and LeMaitre
Vascular SARL, dissolved in 2005. All significant intercompany accounts and transactions have been eliminated
in consolidation.
Foreign Currency Translation
In accordance with Statement of Financial Accounting Standards (SFAS) No. 52, Foreign Currency
Translation, balance sheet accounts of foreign subsidiaries are translated into United States dollars at year-end
exchange rates. Operating accounts are translated at average exchange rates for each year. Net translation gains
or losses are adjusted directly to a separate component of other comprehensive income (loss) within
stockholders’ equity.
Foreign exchange transaction gains (losses), substantially all of which relate to intercompany activity
between the Company and its foreign subsidiaries, amounted to $0.2 million and $(0.2) million and $0.2 million
in 2006, 2005 and 2004, respectively, and are included in other income (expense) in the accompanying
consolidated statements of operations.
During 2004, the Company ceased its operations in France and transferred its production capacity to the
U.S. In connection therewith, in 2005, the Company legally dissolved its wholly owned subsidiary, LeMaitre
Vascular SARL (SARL). In accordance with Financial Accounting Standards Board (FASB) Interpretation
(FIN) No. 37 “Accounting for Translation Adjustments upon Sale of Part of an Investment in a Foreign Entity, an
Interpretation of FASB Statement No. 52”, other comprehensive income of $0.6 million related to the SARL
dissolution has been reclassified from stockholders’ equity to other income in the Company’s 2005 consolidated
statement of operations.
Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the
United States requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities, and disclosure of contingent assets and liabilities, at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ from those
estimates.
Revenue Recognition
The Company’s revenue is derived primarily from the sale of disposable or implantable devices used during
vascular surgery. The Company sells directly to hospitals and to distributors, as described below, and enters into
consigned inventory arrangements with either hospitals or distributors on a limited basis.
F-9
The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin (SAB) No. 104,
Revenue Recognition. SAB 104 requires that four basic criteria must be met before revenue can be recognized:
(1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered;
(3) the fee is fixed or determinable; and (4) collectibility is reasonably assured. The Company generally uses
customer purchase orders or contracts to determine the existence of an arrangement and uses shipping documents
and third party proof of delivery to verify that title has transferred.
The Company assesses whether the fee is fixed or determinable based on the terms of the agreement
associated with the transaction. Substantially all sales transactions are based on fees, or prices, which are
determinable at the time the order is placed by the customer’s purchase order and accepted by Company. Orders
that are not accompanied with a purchase order are either confirmed in writing, or verbally with the customer.
The products the Company sells are primarily off the shelf (non-custom) disposable medical devices. After the
delivery of the product, there is no uncertainty about customer acceptance due to the nature of the product. There
is no contingency for acceptance, warranty or price protection. The Company’s consigned transactions are
immaterial. The Company does not recognize revenue on consigned sales until the customer notifies the
Company that the products have been used. In order to determine whether collection is probable, the Company
assesses a number of factors, including past transaction history with the customer and the creditworthiness of the
customer. If the Company determines that collection is not reasonably assured, it defers the recognition of
revenue until collection becomes reasonably assured, which is generally upon receipt of payment.
Based on these policies, the Company recognizes revenue, net of allowances for returns and discounts, as
products are shipped, based on shipping point terms, at which time title passes to customers. Customers returning
products are entitled to full or partial credit based on the condition and timing of the return. To be accepted, a
returned product must be unopened (if sterile), unadulterated and undamaged, and must have at least 18 months
remaining prior to its expiration date. These return policies apply to sales to both hospitals and distributors. The
Company’s products are subject to a limited warranty that its products have been manufactured with due care.
The amount of products returned to the Company, either for exchange or credit, has not been material.
Nevertheless the Company provides for an allowance for future sales returns based on historical return
experience. The Company’s cost of replacing defective products has not been material and is accounted for at the
time of replacement.
Research and Development Expense
Research and development costs are expensed as incurred.
Shipping and Handling Costs
Shipping and handling fees paid by customers are recorded as sales, with the related expense recorded in
cost of sales.
Advertising Costs
Advertising costs are expensed as incurred and are included as a component of selling, general and
administrative expenses in the accompanying Consolidated Statements of Operations. Advertising costs
amounted to $1.0 million, $0.3 million, and $0.2 million for the years ended December 31, 2006, 2005, and 2004,
respectively.
Cash and Cash Equivalents
The Company considers all highly liquid instruments with an original maturity of three months or less to be
cash equivalents. Cash and cash equivalents are primarily invested in money market investment accounts, U.S.
government securities and certificates of deposit. These amounts are stated at cost, which approximates fair
value.
F-10
Marketable Securities
The Company accounts for its investments in accordance with SFAS No. 115, “Accounting for Certain
Investments in Debt and Equity Securities” (“SFAS No. 115”). Under SFAS No. 115, the Company’s
investments, primarily marketable debt securities, commercial paper and U.S government securities, were
classified as available-for-sale and were carried at fair market value at December 31, 2006. The unrealized gains
(losses) on available-for-sale securities, are recorded in accumulated other comprehensive loss. The Company
considers all highly liquid investments with original maturities of 90 days or less at the time of purchase to be
cash equivalents and investments with original maturities of greater than 90 days to be short-term investments.
Concentrations of Credit Risk
The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of
cash and cash equivalents, marketable securities and accounts receivable. Cash equivalents represent highly
liquid investments with maturities of three months or less at the date of purchase. Marketable securities are
investment grade, interest-earning securities, and are diversified by type and industry. Credit risk related to cash,
cash equivalents and marketable securities are limited based on the creditworthiness of the financial institutions
at which these funds are held.
The Company’s accounts receivable are with customers based in the United States and internationally. The
Company performs ongoing credit evaluations of its customers’ financial condition and generally does not
require collateral. The allowance for doubtful accounts is the Company’s best estimate of the amount of probable
credit losses in the Company’s existing accounts receivable. The Company reviews its allowance for doubtful
accounts on a monthly basis and all past due balances are reviewed individually for collectibility. Account
balances are charged against the allowance after significant collection efforts have been made and potential for
recovery is considered remote. Provisions for allowance for doubtful accounts are recorded in general and
administrative expenses. Losses related to uncollectible amounts have historically been within management’s
estimates.
Fair Value of Financial Instruments
The Company’s financial instruments include cash and cash equivalents, marketable securities, accounts
receivable, trade payables, and notes payable. The fair value of these instruments approximates their carrying
value based upon their short-term nature or variable rates of interest.
Inventory
Inventory consists of finished products, work-in-process and raw materials, and is stated at the lower of cost
or market value and include materials, labor and manufacturing overhead. Cost is determined using the first-in,
first-out (FIFO) method.
Property and Equipment
Property and equipment are recorded at cost. Depreciation is provided over the estimated useful lives of the
related assets using straight-line and accelerated methods as follows:
Description
Computers and equipment
Machinery and equipment
Leasehold improvements
Useful Life
3-5 years
3-10 years
The shorter of its useful life or lease term
F-11
Impairment of Long-Lived Assets
The Company reviews the carrying value of its long-lived assets (primarily property and equipment and
intangible assets) to assess the recoverability of these assets when indicators of impairment occur. The Company
records impairment losses on long-lived assets used in operations when events and circumstances indicate that
the assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less
than the carrying amount of those assets. Impairment is measured based on the fair market value of the affected
asset using discounted cash flows.
As of December 31, 2006, the Company determined an impairment charge of $0.4 million was required
based upon the analysis of unfavorable preliminary data from its U.S. clinical study of the Expedial Vascular
Access Graft. The preliminary clinical data suggested that the device may not compare favorably to ePTFE
grafts. As a result of the Company’s review of the clinical study results, the Company decided to forego further
enrollment in the clinical study and cease the production and sales of this device. During the second quarter of
2006, the Company determined that the future cash flows from the related patents and equipment were less than
their carrying value. Fair value was determined by prices of similar products. Consequently, impairment charges
to reduce the carrying value of these assets to fair value and related inventory to net realizable value totaled
$0.7 million of which $0.3 million related to the impairment of other intangible assets relating to the Expedial
product line patents, approximately $64,000 related to the write-down of related production equipment, and $0.3
million related to inventory write-offs charged against cost of sales. During the fourth quarter of 2006, the
Company sold certain manufacturing equipment, inventory and intellectual property related to the Expedial
Vascular Access Graft product line to CardioTech International, Inc. for total consideration of $0.4 million plus a
five percent royalty on CardioTech’s net sales of its CardioPass brand coronary artery bypass graft for a period of
five years following the first commercial sale of a CardioPass graft. The CardioPass graft is not yet in clinical
trials and there can be no assurance that it will ever be commercialized. As a result of the sale, the Company
subsequently adjusted the initial impairment charge for $0.3 million for the gain on the sale of the intellectual
property and equipment, which is recorded as a adjustment to restructuring charges and adjusted $12,000 against
cost of sales for the inventory sale.
Goodwill
Goodwill represents the amount of consideration paid in connection with business acquisitions in excess of
the fair value of assets acquired and liabilities assumed. In accordance with SFAS No. 142, Goodwill and Other
Intangible Assets, goodwill is evaluated for impairment annually or more frequently if indicators of impairment
are present or changes in circumstances suggest that impairment may exist. The Company evaluates the carrying
value of its goodwill annually in its fourth quarter based on a single reporting unit. The first step of the
Company’s goodwill impairment test, used to identify potential impairment, compares the fair value of the
Company’s reporting unit with its carrying amount, including goodwill. If the fair value of the Company’s
reporting unit exceeds its carrying amount, the goodwill of the reporting unit is considered not impaired, and thus
the second step of the impairment test, used to measure the amount of the impairment loss, is unnecessary. If the
carrying amount of the Company’s reporting unit exceeds its fair value, the second step of the goodwill
impairment test is performed to measure the amount of impairment loss, if any. The second step of the goodwill
impairment test, used to measure the amount of impairment loss, compares the implied fair value of the reporting
unit goodwill as of the date of the impairment review with the carrying amount of that goodwill. The implied fair
value of the Company’s goodwill is determined on the same basis as the amount of goodwill recognized in
connection with a business combination. Specifically, the Company allocates the fair value of its reporting unit to
all of the assets and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit
had been acquired in a business combination as of the date of the impairment review and as if the fair value of
the reporting unit was the price paid to acquire the reporting unit. The excess of the fair value of a reporting unit
over the amounts assigned to its assets and liabilities is the implied fair value of goodwill. If the carrying amount
of the reporting unit goodwill exceeds the implied fair value of that goodwill, an impairment loss shall be
recognized in an amount equal to that excess. The Company has determined that no impairment charges were
required during the years ended December 31, 2006, 2005 and 2004.
F-12
Other Intangible Assets
Other intangible assets consist primarily of patents, trademarks, technology licenses and customer
relationships acquired in connection with business acquisitions and are amortized over their estimated useful
lives, ranging from 5 to 17 years.
Stock-Based Compensation
Effective January 1, 2006, the Company adopted SFAS No. 123 (revised 2004), Share Based Payment
(SFAS No. 123R). Under SFAS No. 123R, the Company is required to recognize, as expense, the estimated fair
value of all share based payments to employees. In accordance with this standard, the Company has elected to
recognize the compensation cost of all share-based awards on a straight-line basis over the vesting period of the
award. The Company adopted SFAS No. 123R under the prospective-transition method, as required by the
standard, using a Black-Scholes model to value stock options. Under this method, the Company recognized
compensation cost for all share-based payments to employees based on the grant date estimate of fair value for
those awards, beginning on January 1, 2006.
As a result of adopting SFAS 123R on January 1, 2006, the Company’s net loss for the year ended
December 31, 2006 was $0.1 million higher than if it had continued to account for share-based compensation
under APB No. 25. Basic and diluted loss per share for the year ended December 31, 2006 would have been
$0.01 higher if the Company had continued to account for share-based compensation under APB No. 25.
Prior to January 1 ,2006, the Company elected to follow Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees, FIN No. 44, Accounting for Certain Transactions Involving
Stock Compensation, and related interpretations, in accounting for its stock-based compensation plans, rather
than the alternative fair value accounting method provided for under SFAS No. 123, Accounting for Stock-Based
Compensation, as this alternative requires the use of option valuation models that were not developed for use in
valuing employee stock options. Under APB No. 25, when the number of options is fixed and the exercise price
of options granted under these plans equals the market price of the underlying stock on the date of grant, no
compensation expense recognition is required. Prior period pro forma stock option information disclosed was
valued based on a Black-Scholes model using the minimum value method.
SFAS No. 123 requires that the Company disclose the pro forma effect of expensing the fair value of stock
options issued to employees. Had the Company accounted for stock options issued to employees using the fair
value model prescribed by SFAS No. 123, the pro forma effect would have been as follows:
Net income (loss), as reported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Plus stock compensation cost as computed under APB No. 25 . . . . . . . . . . . . . . . . . .
Less pro forma SFAS No. 123 option expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2005
2004
$ 55
33
(374)
$ 927
303
(233)
Pro forma net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(286)
$ 997
The Company has computed the fair value of employee stock options using the following assumptions:
Dividend yield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Volatility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk-free interest rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Weighted-average expected option term (in years) . . . . . . . . . . . . . . . . . . . .
Weighted-average fair value per share of options granted . . . . . . . . . . . . . . .
Weighted-average fair value per share of restricted stock awards granted . .
2006
—
65%
4.7%
5
$5.43
$6.07
2004
2005
—
0%
4.2%
6.5
$2.57
—
0%
3.6%
6.5
$1.78
—
F-13
The Company has never declared cash dividends and does not expect to do so in the foreseeable future.
The amount of cash received from the exercise of stock options for 2006 was $47,000. There was no tax
benefit resulting from the exercise of the stock options.
The computation of expected volatility is based on a study of historical volatility rates of comparable
companies during a period comparable to the expected option term. The interest rate for periods within the
contractual life of the award is based on the U.S. Treasury risk-free interest rate in effect at the time of grant. The
computation of expected option term is based on an average of the vesting term and the maximum contractual
life of the Company’s stock options. For the year ended December 31, 2006, the Company used an expected
forfeiture rate of approximately 20%. Computation of expected forfeitures is based on historical forfeiture rates
of the Company’s stock options. Share-based compensation charges will be adjusted in future periods to reflect
the results of actual forfeitures and vesting.
On December 22, 2006, the Company approved awards of its common stock under the 2006 Stock Option
and Incentive Plan. The Company issued 40,464 shares of common stock at the closing price of the day. These
awards are not subject to vesting and were expensed in the period. The Company withheld common stock in
order to provide employees cash proceeds to allow them to pay their minimum tax liability as a result of the
common stock award. In connection therewith, the Company withheld 14,068 shares of common stock at a cost
of $85,000 to cover employees’ minimum tax obligations related to common stock awards on December 22,
2006.
The components of share-based compensation expense for the year ended December 31, 2006 is as follows:
Stock options under SFAS 123(R) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock options for non-employees under SFAS No. 123 . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Common stock awards under SFAS No. 123(R)
Total share-based compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$132
10
262
$404
The Company expects to record the unamortized portion of share-based compensation expense of $1.3
million for existing stock options and restricted stock awards outstanding at December 31, 2006, over a
weighted-average period of 3.5 years, as follows:
Commitments and Contingencies
In the normal course of business, the Company is subject to litigation, claims and assessments for matters
related to, among other things, patent infringement, business acquisitions, employment and product recalls.
During the year ended December 31, 2006, 2005 and 2004, the Company was not subject to any material
litigation or claims and assessments.
As of December 31, 2006, the Company had inventory purchase commitments of $1.3 million which the
Company will satisfy in 2007.
Income Taxes
The Company accounts for income taxes in accordance with SFAS No. 109, Accounting for Income Taxes.
Deferred income taxes are recognized for temporary differences between financial statement and income tax
bases of assets and liabilities for which income tax benefits and obligations will be realized in future years. The
Company does not provide for income taxes on undistributed earnings of foreign subsidiaries, as the Company’s
current intention is to permanently reinvest these earnings.
The Company operates within several taxing jurisdictions and could be subject to audits in these
jurisdictions. These audits can involve complex issues, which may require an extended period of time to resolve
and may cover multiple years.
F-14
Comprehensive Income (Loss)
SFAS No. 130, Reporting Comprehensive Income, establishes standards for reporting and displaying
comprehensive income (loss) and its components in the consolidated financial statements. Comprehensive
income (loss) is defined as the change in equity of a business enterprise during a period from transactions and
other events and circumstances from nonowner sources. Other than reported net income (loss), comprehensive
income (loss) includes foreign currency translation adjustments and unrealized gains and losses on
available-for-sale marketable securities, which are disclosed in the accompanying consolidated statements of
stockholders’ equity and comprehensive income (loss).
Net Income (Loss) Per Share
The Company calculates net income (loss) per share in accordance with SFAS No. 128, Earnings Per Share,
and Emerging Issues Task Force (EITF) 03-6, Participating Securities and the Two Class Method Under FASB
Statement No. 128, Earnings Per Share. EITF 03-6 clarified the use of the “two-class” method of calculating
earnings per share as originally prescribed in SFAS No. 128. Effective for periods beginning after March 31,
2004, EITF 03-6 provides guidance on how to determine whether a security should be considered a “participating
security” for purposes of computing earnings per share and how earnings should be allocated to a participating
security when using the two-class method for computing earnings per share.
Under the two-class method, basic net income (loss) per share is computed by dividing the net income (loss)
applicable to common stockholders by the weighted-average number of common shares outstanding for the fiscal
period. Diluted net income (loss) per share is computed using the more dilutive of (a) the two-class method or
(b) the if-converted method. Under EITF 03-6, the Company has determined that its Series A Convertible
Preferred Stock (“Series A Preferred Stock”) and, upon the adoption of SFAS 123(R), that certain options and
shares of common stock (“common stock awards”) subject to a repurchase feature at other than fair value are
participating securities. The Company’s Series A Convertible Preferred Stock provided for a dividend in the
event of the Company’s liquidation or in the event a dividend was declared on the Company’s common stock.
Effective, January 1, 2006, common stock awards subject to repurchase are allocated to net income based on the
change in the repurchase value during each reporting period. The remaining income (loss) is then allocated to
preferred and common stockholders, pro rata, based on ownership interests since the preferred stock participates
in dividends on the same basis in which the preferred shares convert to common stock. Net losses are not
allocated participating securities. For all periods presented, the application of the two-class method is more
dilutive than the if-converted method. Diluted net income (loss) per share gives effect to all potentially dilutive
securities, including stock options using the treasury method, unless anti-dilutive.
F-15
Net income (loss) per share is based on the following:
Year ended December 31,
2006
2005
2004
Numerator:
Net income (loss) as reported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(1,172) $
55
$ 927
Allocation of net income (loss):
Basic:
Redemption value of common stock awards . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Undistributed net income allocated to participating stockholders:
295
—
Preferred stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
Net income (loss) applicable to participating stockholders . . . . . . . . . . . . . . . . .
Net income (loss) applicable to common stockholders . . . . . . . . . . . . . . . . . . . .
295
(1,467)
Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(1,172) $
7
7
48
55
Diluted:
Redemption value of common stock awards . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Undistributed net income allocated to participating stockholders:
295
—
Preferred stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net income applicable to participating stockholders . . . . . . . . . . . . . . . . . . . . . .
Net income (loss) applicable to common stockholders . . . . . . . . . . . . . . . . . . . .
—
295
(1,467)
Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(1,172) $
7
7
48
55
—
128
128
799
$ 927
—
123
123
804
$ 927
Denominator:
Weighted-average shares of common stock outstanding:
Issued . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Issuable in connection with acquisitions . . . . . . . . . . . . . . . . . . . . . . . . . . .
9,904
—
9,904
8,240
6
8,246
7,918
23
7,941
Common stock equivalents:
Weighted-average shares of common stock issuable upon exercise of
outstanding stock options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
455
413
Shares used in computing diluted net income (loss) per common share, if
dilutive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9,904
8,701
8,354
The computation of basic and diluted net income (loss) per share is as follows:
Year ended December 31,
2006
2005
2004
Basic:
Net income (loss) available for common stockholders . . . . . . . . . . . . . . . . . . . . .
Weighted average shares outstanding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(1,467) $
9,904
48
8,246
$ 799
7,941
Net income (loss) per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ (0.15) $ 0.01
$ 0.10
Diluted:
Net income (loss) available for common stockholders . . . . . . . . . . . . . . . . . . . . .
Weighted-average shares of common stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Common stock equivalents, if dilutive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(1,467) $
9,904
—
48
8,246
455
$ 804
7,941
413
Shares used in computing diluted net income (loss) per common share . . . . . . .
9,904
8,701
8,354
Net income (loss) per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ (0.15) $ 0.01
$ 0.10
F-16
The estimated number of shares issuable in future periods in connection with certain business acquisitions is
based on the stated value of the common stock issuable and the fair value of the common stock at each reporting
date.
For 2005, common stock equivalents represent the effect of options to purchase the Company’s common
stock to the extent the fair value of the common stock exceeds the exercise price of the option. Due to the use of
the two-class method, which is more dilutive than the if-converted method, common stock equivalents do not
include the effect of the conversion of the Company’s Series A Preferred Stock into 1,274,620 shares of common
stock based on a 20-for-1 ratio. The two-class method assumes that a pro rata share of net income is allocated to
preferred stockholders instead of assuming the preferred stock is converted to common stock.
For 2006, shares used in computing diluted net loss per common share excludes 791,934 weighted-average
shares of common stock issuable upon exercise of outstanding stock options, as the effect of including those
shares would be anti-dilutive. An additional 424,921 common stock equivalents were excluded in 2006 as a
result of the Company’s net loss for the period. Due to the use of the two-class method, which is more dilutive
than the if-converted method, common stock equivalents do not include the effect of the conversion of the
Company’s Series A Preferred Stock into 1,274,620 shares of common stock based on a 20-for-1 ratio. The
two-class method assumes that a pro rata share of net income is allocated to preferred stockholders instead of
assuming the preferred stock is converted to common stock.
Recent Accounting Pronouncements
In June 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Correction, a replacement of
APB No. 20, Accounting Changes, and SFAS No. 3, Reporting Accounting Changes. SFAS No. 154 changes the
requirements related to accounting for and reporting of a change in accounting principle. This Statement applies
to all voluntary changes in accounting principle and changes required by a new accounting pronouncement, in the
unusual instance that the pronouncement does not include specific transition provisions. SFAS No. 154 requires
retrospective application to prior periods’ financial statements of changes in accounting principle versus the
previous guidance which allowed the recording of the impact of an accounting change in the current period’s net
income as a cumulative effect adjustment. The Statement is effective for the Company beginning in fiscal year
2007. Adoption is not expected to have a material impact on the Company’s consolidated earnings, financial
condition or cash flows.
In July 2006, the FASB issued Financial Accounting Standards Interpretation No. 48, Accounting for
Uncertainty in Income Taxes (FIN 48). FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in an enterprise’s financial statements in accordance with SFAS No. 109. FIN 48 prescribes a
recognition and measurement method of a tax position taken or expected to be taken in a tax return. FIN 48 also
provides guidance on derecognition, classification, interest and penalties, accounting in interim periods,
disclosures and transitions. FIN 48 is effective for fiscal years beginning after December 15, 2006. The Company
is currently analyzing the expected effects upon adoption of FIN 48 on its consolidated financial position and
results of operations.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, which defines fair value,
establishes a framework for measuring fair value, and expands disclosures about fair value measurements. Where
applicable, this Statement simplifies and codifies related guidance within generally accepted accounting
principles. This statement is effective for financial statements issued for fiscal years beginning after
November 15, 2007, and interim periods within those fiscal years. The Company is currently analyzing the
expected impact from adopting this statement on its financial statements, but currently does not believe its
adoption will have a significant impact on the financial position or results of operations of the Company.
F-17
2. Marketable Securities
Marketable securities consist of the following as of December 31,2006:
Certificates of deposit . . . . . . . . . . . . . . . . . . . . . . . . .
Commercial paper . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Corporate obligations . . . . . . . . . . . . . . . . . . . . . . . . .
Government securities . . . . . . . . . . . . . . . . . . . . . . . . .
Cost
$ 1,225
2,868
9,174
2,156
In 2006, no realized gains or losses on marketable securities were recognized.
$15,423
$15,417
$
Fair
value
Unrealized
gain
Unrealized
(losses)
$ 1,225
2,868
9,176
2,148
$—
—
—
$—
—
—
(8)
$ (8)
2
2
3. Acquisitions
Acquisition of Endomed
On February 2, 2005, the Company acquired certain business assets and operations and assumed liabilities
of Endomed, Inc. (Endomed), a medical device company located in Phoenix, Arizona, for total consideration of
$4.1 million. The consideration consisted of $2.1 million in cash, of which $1.4 million was paid at the closing
($0.8 million to creditors and $0.6 million to Endomed); $0.3 million was withheld as repayment for principal
and interest due from Endomed for an advance; and $0.5 million was payable to creditors less approximately
$27,000 in other adjustments. Additionally, 191,387 shares of common stock at a per share value of $10.45
totaling $2.0 million were issued to certain stockholders of Endomed to extinguish amounts owed by Endomed to
its principal owners. The common stock was priced at the then-current share price of $10.45 as determined by the
Company’s board of directors.
The acquisition was determined to be a purchase of a business based upon the provisions of EITF
Consensus, 98-3, Determining Whether a Non Monetary Transaction Involves Receipt of Productive Assets or of
a Business, and the results of operations from the acquired business have been included in the consolidated
financial statements from the date of acquisition.
The purpose of the acquisition was to acquire the patents (which include manufacturing techniques),
customer relationships, trademarks, the manufacturing facility and equipment and employee base to allow the
Company to enter the endovascular stent graft market. The Company believed that it would be able to leverage
its existing trade name, sales and marketing functions to improve the revenue generating potential of the
business. Furthermore, the Company believed it could leverage its manufacturing, finance and administrative
infrastructure to improve the financial results of the acquired business after the transaction. These factors
supported the Company’s belief that Endomed’s value was higher as a business acquired by the Company rather
than as an independent business, and resulted in goodwill to be recognized in the transaction.
Intangible assets attributable to certain patents, customer relationships and trademarks amounted to
$1.0 million, and are being amortized over their estimated useful lives between 5.0 and 13.8 years, as shown
below:
Intangible Asset Class
(In
thousands)
Weighted Average
Useful Life
Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Customer relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total Intangible Assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$696
213
50
$959
13.8
7.5
5.0
F-18
The purchase price was allocated as follows as of the date of acquisition:
Accounts receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property, plant and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Capital lease obligation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Common stock and paid in capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(in thousands)
$
491
396
369
2,170
959
45
(469)
(247)
(250)
(105)
(2,000)
Cash paid at closing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 1,359
The following unaudited pro forma information represents the consolidated results of operations of the
Company and Endomed as if the acquisition had occurred on January 1, 2004. The pro forma information gives
effect to the elimination of transactions between the Company and Endomed, principally sales and related costs,
amortization of intangible assets, an increase in interest expense related to acquisition financing and related tax
effects.
Net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net (loss) applicable to common stockholder per share:
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Year ended
December 31, 2004
(in thousands, except
per share data)
$28,040
(1,400)
$ (0.18)
$ (0.18)
Acquisition of AnastoClip Product Line and Related Operations
On February 6, 2004, and again on May 26, 2004, the Company acquired certain business assets and
operations of the United States Surgical division of Tyco Healthcare Group LP (“US Surgical”), a medical device
company located in Connecticut, for total consideration of $1.0 million. The consideration consisted of $0.8
million in cash to US Surgical, of which $0.5 million was paid at the closing, $0.1 million was payable upon the
transfer of certain equipment and $0.2 million was payable on May 26, 2006. Additionally, $0.2 million in
common stock was paid to a group of licensors of certain surgical clip technology for the assumption of the
license agreement US Surgical had with the licensors. Of this amount, $0.1 million of the consideration was paid
upon the assignment of the license agreement, and the balance of the $0.1 million of common stock was paid
following the first anniversary of assignment of the license agreement. The common stock value of $0.1 million
was paid through the issuance of 11,455 shares priced at the then-current share price of $8.73 as determined by
the Company’s board of directors. Further common stock value of $0.1 million was paid through the issuance of
9,560 shares priced at the then-current share price of $10.75 as determined by the Company’s board of directors.
The acquisition was determined to be a purchase of a business, based on the provisions of EITF Consensus,
98-3, Determining Whether a Non Monetary Transaction Involves Receipt of Productive Assets or of a Business.
In addition, the Company retained the majority of the manufacturing equipment, production techniques, trade
name and operating rights after the transaction. The results of operations from the acquired business have been
included in the consolidated financial statements from the date of acquisition.
F-19
The purpose of the acquisition was to acquire the patents, trademarks and manufacturing equipment to allow
the Company to reasonably enter the vessel attachment market. The Company believed that it would be able to
leverage its existing trade name, sales and marketing functions to improve the revenue generating potential of the
business. Furthermore, the Company believed it could leverage its manufacturing, finance and administrative
infrastructure to improve the financial results of the acquired business after the transaction. These factors
supported the Company’s belief that the value of the anastomotic clip business was higher as a business acquired
by the Company, a company focused on vascular surgery, than as a part of Tyco Healthcare Group LP, a larger
company selling into a range of medical specialties. As a result, goodwill was recognized in the transaction.
Intangible assets attributable to certain patents and trademarks amounted to $0.4 million, and are being
amortized over their estimated useful lives as follows:
Intangible Asset Class
(in thousands)
Weighted Average
Useful Life
Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$346
49
$395
8.8
5.0
The purchase price was allocated as follows as of the date of acquisition:
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property, plant and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued purchase price . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Common stock and paid-in capital
Cash paid at closing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(in thousands)
$ 161
137
386
395
(79)
(300)
(200)
$ 500
4. Inventory
Inventory consists of the following:
Raw materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Work-in-process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finished products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
As of December 31
2006
2005
(in thousands)
$2,098
501
3,482
$2,457
461
2,229
Total inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$6,081
$5,147
F-20
5. Property and Equipment
Property and equipment consists of the following:
Computer hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Machinery and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Leasehold improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gross property and equipment
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less accumulated depreciation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
As of December 31,
2006
2005
(in thousands)
$1,558
2,846
1,482
5,886
3,497
$1,368
2,947
1,390
5,705
3,047
Net property and equipment
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$2,389
$2,658
Depreciation expense amounted to approximately $1.1 million in 2006 and 2005, and $0.8 million in 2004.
6. Goodwill and Other Intangibles
Goodwill consists of the following:
Balance at beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additions for acquisitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign currency effect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
As of December 31,
2006
2005
(in thousands)
$8,853
—
—
$6,709
2,170
(26)
Balance at end of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$8,853
$8,853
Intangibles consist of the following:
(in thousands)
Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trademarks and technology license . . . . . . . . . . .
Customer relationships . . . . . . . . . . . . . . . . . . . . .
Gross intangibles . . . . . . . . . . . . . . . . . . . . . . . . . .
2006
2005
Gross
Carrying
Value
$1,534
898
213
$2,645
Accumulated
Amortization
$520
141
54
$715
Gross
Carrying
Value
$1,789
896
213
$2,898
Accumulated
Amortization
$359
101
26
$486
These assets are being amortized over useful lives ranging from 5 to 17 years. The weighted-average
amortization period for these intangibles as of December 31, 2006 is 11.4 years. Amortization expense amounted
to $0.2 million in 2006, 2005 and 2004, respectively, and is included in general and administrative expense.
Estimated amortization expense for each of the five succeeding fiscal years, based upon the intangible assets
at December 31, 2006, is as follows:
2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$208
224
223
212
180
(in thousands)
F-21
7. Financing Arrangements
In April 2003, the Company amended its $1.1 million five-year term loan with Brown Brothers Harriman &
Co. (Brown Brothers), to a $2.2 million five-year term loan due in April 2008. Borrowings under the loan were
payable in quarterly payments of $0.1 million at an interest rate of prime plus 0.5%, or 3.5% over three month
LIBOR. At December 31, 2005, the balance was $1.1 million at an interest rate of 7.75%.
On February 2, 2005, in connection with the Company’s acquisition of certain assets and operations of
Endomed, Inc., the Company amended its existing revolving line of credit with Brown Brothers to allow
borrowings in an amount not to exceed $3.5 million for a twelve-month period, and thereafter $2.25 million.
Borrowings under the line of credit accrued interest at the bank’s prime rate and were due upon demand as of
December 31, 2005. At December 31, 2005, the balance was $0.7 million.
On May 20, 2006, the Company amended and restated its revolving line of credit with Brown Brothers to
commit the facility and allow borrowing in an amount not to exceed $5.5 million.
On September 25, 2006, the Company entered into an additional $2.5 million term loan with
Brown Brothers. This term loan included customary financial covenants and interest at a rate of 10% per annum.
The term loan had an expiration date of September 30, 2008, was prepayable without penalty, and was required
to be repaid if and to the extent that the Company received net proceeds from any sale of its equity in excess of
$2.5 million.
On October 24, 2006, the Company used $3.9 million of the net proceeds from the public offering to pay
down all outstanding indebtedness to Brown Brothers. As of December 31, 2006, the Company did not have any
outstanding balances on the term note and revolving line of credit. The Company maintains a $5.5 million
revolving line of credit as of December 31, 2006 which expires on September 30, 2008 with interest at the bank’s
prime rate.
The Company’s revolving line of credit is collateralized by substantially all of the assets of the Company. In
addition, the Company is required to meet certain financial and operating covenants. At December 31, 2006 and
2005, the Company was in compliance with these covenants.
Interest expense amounted to $0.3 million, $0.2 million and $0.1 million for the years ended December 31,
2006, 2005 and 2004, respectively.
8. Accrued Expenses
Accrued expenses consist of the following:
Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Business acquisition related payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income and other taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Professional fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
As of December 31,
2006
2005
(in thousands)
$2,270
—
852
439
967
$1,781
400
311
212
894
$4,528
$3,598
F-22
9. Commitments and Contingencies
Leases
The Company conducts certain of its operations in leased facilities, which are accounted for as operating
leases. Certain leases include renewal options. In addition, the Company leases automobiles and capital
equipment under both operating and capital leases. Assets held under capital leases amounted to $0.3 million at
December 31, 2006 and 2005. Accumulated amortization amounted to $0.2 million and $0.1 million at
December 31, 2006 and 2005, respectively. Capital lease asset amortization is included in depreciation and
amortization.
In connection with past operations in France, the Company had occupied the building under a sale-leaseback
arrangement. Upon dissolution of the French operations, the building was sold to a third party in 2005 resulting
in a gain of approximately $66,000 which is included in other income in the 2005 consolidated statement of
operations.
At December 31, 2006, the minimum rental commitments under all non-cancelable capital and operating
leases with initial or remaining terms of more than one year, for each of the following fiscal years, are as follows:
2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2011 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Thereafter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less amount representing interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Capital
Leases
Operating
Leases
(in thousands)
$1,191
800
467
201
14
10
$2,683
$ 33
—
—
—
—
—
33
(1 )
Present value of net minimum lease payments . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 32
Rent expense amounted to $1.2 million for the years ended December 31, 2006, and 2005 and $1.0 million
for the year ended December 2004.
Purchase Commitments
The Company has a purchase commitment to purchase $1.3 million of inventory in 2007.
10. Income Taxes
The Company’s provision (benefit) for income taxes is based upon the following components of income
(loss) before income taxes:
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Year ended December 31,
2006
2005
2004
(in thousands)
$ 822
(244)
$(460)
(60)
$1,908
(767)
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$(520)
$ 578
$1,141
Certain of the Company’s foreign subsidiaries are included in the United States tax return as branches, but
are included as foreign for purposes of the table above.
F-23
The Company’s provision for income taxes is as follows:
Currently payable (refundable):
Federal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred (benefit):
Federal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred taxes are attributable to the following temporary differences:
Deferred tax assets:
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Foreign net operating loss carryovers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Tax credit carryovers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reserves and accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other intangibles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gross deferred tax assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred tax asset
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred tax liabilities:
Goodwill
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net deferred tax liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Short-term deferred tax asset
Year ended December 31,
2006
2005
2004
(in thousands)
$582
102
(26)
658
(43)
(11)
48
(6)
$240
14
87
341
150
32
$172
7
7
186
68
(40)
182
28
$652
$523
$214
As of December 31,
2006
2005
(in thousands)
$
359
694
98
171
300
(135)
16
1,503
(1,107)
396
(833)
(437)
(396)
$
47
524
72
226
125
50
70
1,114
(954)
160
(604)
(444)
(160)
Non-current deferred tax liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
($
833)
($ 604)
F-24
A reconciliation of the federal statutory rate to the Company’s effective tax rate for the year ended
December 31 is as follows:
Federal statutory rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State tax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Effect of foreign taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Valuation allowance:
Benefit of loss—Germany . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Assets recorded to extent of available carryback . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research credits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Permanent differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Uncertain tax provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2006
2005
2004
34.0% 34.0% 34.0%
(9.8)% 1.6% 0.4%
(83.6)% 33.1% —
0.0% (7.7)%
—
(45.4)
(4.2)% (11.8)%
42.5% 12.4% 15.3%
(7.8)% (10.5)%
—
(20.7)% 9.1% 2.4%
(49.4%) —
—
7.1% 12.3% (3.5)%
Effective tax rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(125.3)% 90.5% 18.6%
In 2005, the Company had a net operating loss carryover in the United Kingdom of $0.4 million which does
not expire. The Company also had a net operating loss carryover in Japan of $1 million as of December 31, 2005.
This carryover begins to expire starting in 2011 through 2012. The Company had federal and state tax credit
carryovers of $72,000 which expires through 2025.
In 2006, the Company dissolved LeMaitre Vascular Limited, and the operating loss carryover of
$0.4 million is no longer available. The Company has a net operating loss carryover in Japan of $2 million which
expires starting in 2011 through 2013. The Company also has state tax credits carryovers of $98,000 which
expires through 2021.
The American Jobs Creation Act of 2004 (the “Jobs Act”), enacted on October 22, 2004, provides for a
temporary 85% dividends received deduction on certain foreign earnings repatriated during a one-year period.
The deduction would result in an approximately 5.25% federal tax rate on the repatriated earnings. To qualify for
the deduction, the earnings must be reinvested in the United States pursuant to a domestic reinvestment plan
established by a company’s Chief Executive Officer and approved by a company’s board of directors. Certain
other criteria in the Jobs Act must be satisfied as well. The Company did not repatriate foreign earnings under the
provisions of the Jobs Act.
11. Stockholders’ Equity
Series A Convertible Preferred Stock
In June, 1998, the Company sold 63,731 shares of its designated Series A Convertible Preferred Stock to
Housatonic Equity Investors, L.P. in a private placement for $2.35 per share in exchange for $3,000,009.
In connection with the Company’s public offering, 63,731 shares of Series A Convertible Preferred Stock
were automatically converted into 1,274,620 shares of common stock on a 20-for-1 basis.
As of December 31, 2006, there were 5,000,000 shares of preferred stock authorized. There were no shares
issued or outstanding as of December 31, 2006.
Stock Option Plans
Under its 1997, 1998, 2000 and 2004 stock option plans, the Company allowed for the granting of options in
the form of incentive stock options or nonqualified options to employees, directors, and consultants to purchase
up to 1,688,702 shares of common stock. Incentive stock options are required to be issued at not less than fair
F-25
market value at the date of the grant, and generally vest over four or five years. The term of the options is
determined by the Company’s board of directors, but in no event will exceed ten years from date of grant.
Options to purchase 386,272 shares of common stock and an award for the purchase of 252,852 shares of
the Company’s common stock were issued to two key executives in 1997. The options and award were subject to
restricted stock agreements which provided the employee with a repurchase right and the Company with a call
right at a formula-based price in the event of death, disability and voluntary and involuntary termination, as
defined. The Company accounted for these options and award until 1998 using variable plan accounting since the
exercise of the employee repurchase price was considered likely based on the lack of marketability of the
Company’s common stock. Subsequent to the sale of $0.8 million of the Company’s common stock in 1998 to
individual, non-institutional investors, the Company determined that the likelihood of the exercise of the
repurchase feature was remote based upon the value of the formula-based price compared to the value of the
common sold to the individual investors. In addition, due to bank covenant restrictions, the Company determined
its ability to exercise the call right, which was terminated by the Company in December 2003, was also remote.
Since 1998, the value of the Company’s common stock has always exceeded the formula-based price.
Consequently, subsequent to 1998 the Company has accounted for these options and award using fixed plan
accounting.
Upon adoption of SFAS No. 123R, based on the use of the prospective method of adoption, these options
and this award will continue to be accounted for under APB No. 25 as fixed plan arrangements. Concurrently
with the adoption of SFAS No. 123R, the Company applied the guidance included in Accounting Series Release
No. 268 and EITF No. D-98 with respect to the redemption feature related to these options and award. The effect
of the adoption resulted in the classification of the intrinsic value of the redemption feature of $6.5 million at
January 1, 2006 from retained earnings to other than permanent equity. During the 2006, the value of the
redemption feature increased by $0.3 million to $6.8 million, which amount was charged against retained
earnings. The repurchase and call right features terminated upon the completion of the Company’s initial public
offering of the Company’s common stock completed on October 19, 2006 resulting in a $6.8 million credit to
additional paid in capital.
In May 2006, the Company approved a 2006 Stock Option and Incentive Plan (the 2006 Plan), which
became effective upon the initial public offering. The plan allows for granting of incentive stock options,
non-qualified stock options, stock appreciation rights, restricted stock units, (“RSU”), unrestricted stock awards
and deferred stock awards to officers, employees, directors, and consultants of the Company. The Company has
reserved for issuance of an aggregate of 750,000 shares of common stock under the 2006 Plan. In connection
with the adoption of the 2006 Plan, no further option grants are permitted under the 1997, 1988, 2000, and 2004
stock option plans and any expirations, cancellations or terminations under the previous plans are available for
issuance under the 2006 plan. The stock options provide the holder the right to purchase common stock at an
exercise price not less than the fair market value of the stock on the date of grant and the expected term will not
exceed ten years. The Company issued 193,391 stock options for the year ended December 31, 2006 with a
weighted average fair value per share of $11.61. The Company may satisfy awards upon exercise of stock
options or restricted stock units with either newly issued or treasury shares.
F-26
A summary of the Company’s stock option activity for all plans and related information is as follows:
Aggregate
intrinsic
value
Weighted-
average
contractual
term
Balance outstanding at January 1 ,2004 . . .
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . .
Forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . .
Number of
shares
1,263,918
29,118
(12,049)
(73,250)
Option Prices
$ 8.73 – $ 8.73
$ 3.63 – $ 4.15
$ 3.15 – $ 8.73
Balance outstanding at December 31,
2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . .
Forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,207,737
471,946
(28,808)
(139,642)
Balance outstanding at December 31,
2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . .
Forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,511,233
193,391
(30,004)
(73,366)
Balance outstanding at December 31,
$10.45 – $11.78
$ 2.36 – $ 4.44
$ 3.63 – $11.78
$ 5.95 – $12.37
$ 0.10 – $ 4.15
$ 3.63 – $12.37
Weighted-
average
exercise
price
$ 3.65
8.73
3.66
4.87
3.70
11.18
3.35
7.02
5.73
9.47
1.57
9.88
2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,601,254
$ 0.10 – $12.37
6.07
$9,721,277
4.7
Options exercisable at December 31,
2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,004,825
$ 0.10 – $11.78
3.66
$3,676,635
3.0
Awards available to grant at December 31,
2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
612,928
As of December 31, 2006, shares subject to outstanding options by range of exercise price are as follows:
Options Outstanding
Options Exercisable
Outstanding
as of
December 31,
2006
Weighted-
average
remaining
years of
contractual
life
Range of exercise prices
$ 0.01 – $ 1.24 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 1.24 – $ 2.47 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 2.47 – $ 3.71 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 3.71 – $ 4.95 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 4.95 – $ 6.19 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 6.19 – $ 7.42 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 7.42 – $ 8.66 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 8.66 – $ 9.90 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 9.90 – $11.13 . . . . . . . . . . . . . . . . . . . . . . . . . . .
$11.13 – $12.37 . . . . . . . . . . . . . . . . . . . . . . . . . . .
322,678
245,460
78,060
43,250
98,248
32,500
262,714
10,819
183,128
324,397
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,601,254
0.4
1.3
2.9
3.9
6.7
5.4
6.2
7.2
8.1
8.1
4.7
Weighted-
average
exercise
price
Exercisable
as of
December 31,
2006
Weighted-
average
exercise
price
$ 0.10
1.79
3.50
4.31
5.97
7.03
7.88
8.73
10.55
11.95
$ 6.07
322,678
245,460
78,060
43,250
10,100
27,200
181,947
4,327
41,468
50,335
1,004,825
$ 0.10
1.79
3.50
4.31
6.13
7.03
7.82
8.73
10.56
11.76
$ 3.66
Restricted Stock Award Units
On December 22, 2006, the Company began issuing restricted stock unit awards (RSUs) as an additional
form of equity compensation to its employees and officers, pursuant to the Company’s stockholder-approved
F-27
2006 Plan. The Company issued 133,000 RSUs at fair value of approximately $0.8 million. RSUs entitle the
grantee to an issuance of stock at no cost. RSUs generally vest over a period of time determined by the
Company’s Board of Directors at the date of grant and unvested RSUs are forfeited and cancelled as of the date
that employment terminates. RSUs are settled in shares of the Company’s common stock upon vesting. A portion
of the outstanding RSUs began vesting in December 2006.
The following is a summary of the status of the Company’s restricted stock units, which are subject to the
fair value accounting requirements of SFAS 123(R) as of December 31, 2006 and the activity during the year
ended December 31, 2006.
Nonvested awards at December 31, 2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Shares
—
133,000
—
—
Nonvested awards at December 31, 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
133,000
Weighted
Average
Grant-
Date Fair
Value
$ —
6.07
—
—
$6.07
As of December 31, 2006, there was unrecognized compensation cost related to RSUs totaling $0.8 million,
net of estimated forfeitures, which will be recognized over a weighted-average period 3 years. The Company
may withhold common stock upon its employees’ vesting in RSU’s in order to provide the employees with cash
proceeds to cover their minimum tax liability as a result of the RSU’s having vested.
The Company accounts for stock options issued to non-employees using the fair value method prescribed by
SFAS No. 123. The Company computes the fair value of non-employee stock options using the Black-Scholes
option-pricing model using an appropriate volatility factor and records the fair value of non-employee stock
options as expense over either the vesting term of the option or the service period. During 2006, 2005 and 2004,
the Company recorded approximately $10,000, $41,000 and $31,000, respectively, of compensation expense
related to stock options granted to non-employees. The Company has computed the fair value of non-employee
stock options using the Black-Scholes model with the following assumptions:
Risk-free interest rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dividend yield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Volatility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected life (years) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2006
2005
2004
4.7% 4.2% 3.6%
0.0% 0.0% 0.0%
65.0% 65.0% 80.0%
5.0
4.3
5.0
In connection with its preparation for its initial public offering of its common stock, the Company
reassessed the valuations of its common stock issued during all periods presented in the accompanying financial
statements based on the provisions of the AICPA’s Practice Aid Valuation of Privately-Held-Company Equity
Securities Issued as Compensation (TPA). In conducting this assessment, the Company took into consideration
the market and income approaches to valuation as set forth in the TPA. The Company believes that the valuation
methodologies that it used prior to this public offering are consistent with the TPA. Based on the foregoing
analysis, the Company concluded that for all options granted prior to October 19, 2006 in no case did the fair
value of common stock exceed the exercise price for these options at the time of grant.
Employee Stock Purchase Plan
In May 2006, the Board of Directors and stockholders approved the 2006 Employee Stock Purchase Plan
(“ESPP”) which is qualified under Section 423 of the Internal Revenue Code. The ESPP is available to all
F-28
eligible employees, who, through payroll deductions, will be able to individually purchase shares of the
Company’s common stock semi-annually at a price equal to 90% of the fair market value on the semi-annual
purchase dates. The Company has reserved for issuance an aggregate of 250,000 shares of common stock for the
ESPP. At December 31, 2006 there were no shares issued.
12. Profit-Sharing Plan
The Company offers a 401(k) profit-sharing plan (the Plan) covering eligible United States employees to
make tax deferred contributions, a portion of which are matched by the Company. The Company may make
discretionary matching contributions to the Plan in an amount determined by its Board of Directors. Company
contributions vest ratably with six years of employment and amounted to approximately $0.2 million for year
ended December 31, 2006, and $0.1 million for 2005 and 2004, respectively.
13. Restructuring Charges
The Company initiated a plan to close its French subsidiary in 2003, and as a result, incurred severance and
other costs. These costs amounted to $0.1 million and $0.4 million in 2005 and 2004, respectively. There were no
further costs incurred with respect to this exit-activity cost.
The Company initiated a plan to close its Florida manufacturing operations in 2005, and as a result, incurred
severance, lease termination and other costs. These costs amounted to $0.8 million in 2005. There were further
costs incurred with respect to this exit-activity cost.
The Company initiated a plan to close its UK manufacturing operations in 2005, and as a result, incurred
severance, lease termination and other costs. These costs amounted to $31,000 and $0.1 million in 2006 and
2005, respectively. No further costs are expected to be incurred with respect to this exit-activity cost.
The Company initiated a plan to close its Arizona manufacturing operations in 2006, and as a result,
incurred severance and other costs. These costs amounted to $0.2 million in 2006. The Company estimates any
additional exit activity cost to be less than $0.1 million.
The components of the restructuring costs are as follows:
Year ended December 31,
Severance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease termination costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Activity related to restructuring costs is as follows:
Balance at beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Plus:
2006
2005
2004
$ 87
—
170
$257
$323
546
129
$998
$435
—
—
$435
Year ended December 31,
2006
2005
2004
(in thousands)
$ 79
$484
$217
Current year restructuring costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
257
998
435
Less:
Payments for termination of contractual obligations . . . . . . . . . . . . . . . .
Payment of employee severance costs . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
149
279
537
111
212
121
719
—
Total
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 46
$217
$ 79
F-29
14. Segment and Enterprise-Wide Disclosures
SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information, establishes standards
for reporting information regarding operating segments in annual financial statements. Operating segments are
identified as components of an enterprise about which separate, discrete financial information is available for
evaluation by the chief operating decision-maker in making decisions on how to allocate resources and assess
performance. The Company views its operations and manages its business as one operating segment. No discrete
operating information other than product sales is prepared by the Company, except by geographic location, for
local reporting purposes. All revenues were generated in the United States, Europe and Japan, and substantially
all assets are located in the United States.
The Company sells products in three product categories, Endovascular & Dialysis Access, Vascular and
General Surgery, and has also derived a limited amount of revenue from manufacturing devices under private
label arrangements. Net sales for the years ended December 31, 2006, 2005 and 2004 in these product categories
were as follows:
Endovascular & Dialysis Access . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vascular . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Branded product sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Private Label
Year ended December 31,
2006
2005
2004
$ 9,833
20,992
3,803
34,628
—
(in thousands)
$ 6,774
19,654
3,600
30,028
699
$ 3,340
18,233
3,682
25,255
928
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$34,628
$30,727
$26,183
Net sales to unaffiliated customers by geographic area are as follows:
United States and Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .
Rest of world (principally Europe)
$22,362
12,266
(in thousands)
$20,056
10,671
$17,689
8,494
$34,628
$30,727
$26,183
Year ended December 31,
2006
2005
2004
The Company’s total assets are held in the following geographic areas as follows:
United States and Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .
Rest of world (principally Europe)
$51,768
5,195
(in thousands)
$20,725
4,343
$16,098
4,403
$56,963
$25,068
$20,501
Year ended December 31,
2006
2005
2004
F-30
15. Related-Party Transactions
The Company leased its St. Petersburg, Florida manufacturing facility from a related party who owned
approximately 0.5% of the Company’s common stock and who also acted as a consultant to the Company. The
rents paid to this landlord amounted to $0.3 million in 2004 and 2005. On November 15, 2005, the Company
entered into a lease termination agreement with the related party to terminate this lease for $0.5 million. In
addition, the Company agreed to purchase 47,279 shares of the related party’s common stock at $11.30 per share,
the then fair market value of the Company’s common stock, totaling approximately $0.6 million. No consulting
fees were paid in 2006 and 2005.
For 2005 and 2004 several of the Company’s European sales distributors owned shares of the Company’s
common stock. No single distributor owned more than 2% of the Company’s common stock during the year
period ended December 31, 2005. Total sales, valued at amounts intended to be arms-length, to these distributors
amounted to $2.0 million in 2004 and $3.1 million in 2005 or approximately 7.5% and 10.1%, of the Company’s
consolidated sales, respectively. Amounts due from these distributors totaled $0.4 million and $0.5 million as of
December 31, 2004 and 2005, respectively, or 10.9% and 13.0% of the Company’s consolidated accounts
receivable, respectively.
At all times since the Company’s initial public offering, including as of December 31, 2006, there were no
sales distributors which owned more than 5% of the Company’s common stock.
16. Quarterly Financial Data (unaudited)
Three months ended
Fiscal Year 2006
March 31
June 30
September 30 December 31
Total net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gross profit
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) from operations . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$8,571
6,310
462
$ 370
$ 8,760
6,095
(1,050)
($ 1,090)
$ 8,540
6,261
342
220
$
$ 8,757
6,595
(433)
($ 674)
Net income (loss) available to common stockholders:
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 0.02
($ 0.14)
$ 0.01
($ 0.05)
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 0.02
($ 0.14)
$ 0.01
($ 0.05)
(in thousands)
Three months ended
Fiscal Year 2005
March 31
June 30
September 30 December 31
Total net sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gross profit
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) from operations . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net income (loss) available to common stockholders:
Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$7,501
5,440
432
51
$
$ 0.01
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$ 0.01
(in thousands)
$ 7,529
5,372
(166)
5
$
$ 7,820
5,532
(400)
42)
($
$ 7,877
5,456
556
41
$
—
—
($ 0.01)
($ 0.01)
—
—
F-31
SCHEDULE II
LEMAITRE VASCULAR
VALUATION AND QUALIFYING ACCOUNTS
FOR THE YEARS ENDED DECEMBER 31, 2006, 2005 AND 2004
Description
Reserves deducted from assets to which they apply:
Allowance for doubtful accounts and sales returns:
COLUMN A
Balance at
Beginning of
Period
COLUMN B
Additions
Charged to
Income
COLUMN C
Deductions
from
Reserves
COLUMN D
Balance at
End of
Period
(in thousands)
Year ended December 31, 2006 . . . . . . . . . . . . . . . . . .
Year ended December 31, 2005 . . . . . . . . . . . . . . . . . .
Year ended December 31, 2004 . . . . . . . . . . . . . . . . . .
$120
145
118
$21
16
(1)
$ 39
41
(28)
$102
120
145
F-32
EXHIBIT INDEX
21.1 Subsidiaries of the Registrant
23.1 Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm
31.1 Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certification pursuant to 18 U.S.C. Section 1350
32.2 Certification pursuant to 18 U.S.C. Section 1350
Board of Directors
George W. LeMaitre
chairman of the Board,
president & chief executive officer
leMaitre vascular, inc.
Director since 1992
Duane M. DeSisto 1, 2
president & chief executive officer
insulet corporation
Director since 2006
David N. Gill 1, 2
Retired senior vice president &
chief financial officer
nxstage Medical, inc.
Director since 2006
Michael C. Jackson 3
founding partner
housatonic partners
Director since 2005
Lawrence J. Jasinski 2, 3
president & chief executive officer
soteira, inc.
Director since 2003
Cornelia W. LeMaitre
vice president, human Resources
leMaitre vascular, inc.
Director since 1992
George D. LeMaitre, MD
founder; chairman of the scientific Advisory Board
leMaitre vascular, inc.
Director since 1983
Guido J. Neels 1, 3
Retired chief operating officer
Guidant corporation
Director since 2006
David B. Roberts
chief financial officer
leMaitre vascular, inc.
Director since 2001
1 Member of the Audit committee
2 Member of the compensation committee
3 Member of the nominating and Governance committee
Stockholder Information
Price Range of Common Stock
our common stock has traded on the nAsDAQ
Global Market under the symbol “LMAT” since
our october 19, 2006 ipo. the following table
sets forth the high and low closing sale prices of
our common stock for the periods indicated.
Year Ended December 31, 2006
Price Range
High
Low
$6.45
$5.50
Fourth Quarter
(from October 19 to December 31)
Dividends
We have not declared or paid any cash dividends
on our capital stock since our inception. We
currently expect to retain future earnings, if any,
for use in the operation and expansion of our
business and do not anticipate paying any cash
dividends in the forseeable future. As of April
23, 2007, there were approximately 288 holders
of record of our common stock. Because many
of our shares of common stock are being held
by brokers and other institutions on behalf of
stockholders, we are unable to estimate the total
number of stockholders represented by these
record holders.
Transfer Agent
inquiries concerning the transfer or exchange of
shares, lost stock certificates, duplicate mailings
or changes of address should be directed to our
transfer agent at:
Investor Information Requests
investors, stockholders and security analysts
seeking information about us should refer to our
investor relations website at ir.lemaitre.com or
call investor Relations at 1 -781 -221 -2266.
Mellon Investor Services LLC
c/o Mellon Bank, n.A.
p.o. Box 3316
south hackensack, nJ 07606
1 -800 -820 -6807
1 -201 -680 -6578 (collect)
www.melloninvestor.com
Independent Auditors
Ernst & Young LLP
Boston, MA
Annual Meeting
the annual meeting of stockholders will take
place on Wednesday, June 6, 2007, beginning
at 10:00 a.m. at the offices of Goodwin procter
llp, 53 state street, exchange place, Boston,
Massachusetts.
Other Information
copies of our Annual Report on form 10 -K,
Quarterly Reports on form 10 -Q, current
Reports on form 8 -K and amendments to those
reports are available free of charge through
the investor relations section of our website at
ir.lemaitre.com. copies of these reports are also
available by writing us at:
Investor Relations
LeMaitre Vascular, Inc.
63 second Avenue
Burlington, MA 01803, usA
Trademarks
leMaitre, pruitt -inahara, endofit, vascutape,
expandable leMaitre valvulotome, Glow ‘n tell,
Reddick, expedial, optilock, invisiGrip, pruitt,
Anastoclip and the leMaitre vascular logo
are registered trademarks of leMaitre vascular,
and unifit and f3 are trademarks of
leMaitre vascular.
Corporate Headquarters
leMaitre vascular, inc.
63 second Avenue
Burlington, MA 01803 usA
Web: www.lemaitre.com
tel: +1 -781 -221 -2266
fax: +1 -781 -425 -5049
International Headquarters
leMaitre vascular Gmbh
otto -volger -str. 5a/b
65843 sulzbach/ts.
Germany
tel: +49 -(0)6196 -659230
fax: +49 -(0)6196 -527072
Asia-Pacific Headquarters
leMaitre vascular GK
1f Kubodera twin tower Bldg.
2 -9 -4 Kudan -minami, chiyoda -ku
tokyo 102 -0074 Japan
tel: +81 -(0)3 -5215 -5681
fax: +81 -(0)3 -5215 -5682