Current Report

 

 

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) of the

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): January 7, 2013

 

 

ATRICURE, INC.

(Exact name of registrant as specified in charter)

 

 

 

Delaware   000-51470   34-1940305

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

6217 Centre Park Drive

West Chester, OH

  45069
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (513) 755-4100

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On January 7, 2013, AtriCure, Inc. (“AtriCure” or the “Company”) issued a press release regarding its preliminary financial results for the fourth quarter and full year ended December 31, 2012. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

Item 7.01. Regulation FD Disclosure.

On January 7, 2013, the Company is giving a presentation to investors discussing, among other topics, an overview of the Company’s business and growth strategy. A copy of the investor presentation, which is available at www.atricure.com, is being furnished as Exhibit 99.2 to this Form 8-K and is incorporated herein by reference.

The Company in the investor presentation discloses certain financial results both in accordance with generally accepted accounting principles (GAAP) and on a non-GAAP basis with adjustments for certain items. The Company’s management believes that presentation of these non-GAAP financial measures and their related reconciliations are useful to investors because the non-GAAP financial measures provide investors with a basis for comparing the results to financial results from prior periods.

Information in the investor presentation contains forward-looking statements regarding future events and performance of the Company. All such forward-looking statements are based largely on the Company’s experience and perception of current conditions, trends, expected future developments and other factors and on management’s expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those factors described in the investor presentation and in the Company’s filings with the Securities and Exchange Commission.

The information in each of Item 2.02 and Item 7.01 of this Form 8-K and in the press release attached as Exhibit 99.1 and the investor presentation attached as Exhibit 99.2 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in each of Item 2.02 and Item 7.01 of this Form 8-K and each of Exhibit 99.1 and Exhibit 99.2 shall not be incorporated by reference in any filing or other document under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filing or document.

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

No.

  

Description

99.1    Press Release dated January 7, 2013
99.2    Investor Presentation


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    ATRICURE, INC.
Dated: January 7, 2013     By:   /s/ M. Andrew Wade
      M. Andrew Wade
      Vice President, Finance
Press Release
LOGO    EXHIBIT 99.1

Contact:

AtriCure, Inc.

Andy Wade

Vice President, Finance

(513) 755-4564

awade@atricure.com

Investor Relations Contact:

Lynn Pieper

Westwicke Partners

415-202-5678

Lynn.pieper@westwicke.com

AtriCure Announces Preliminary Results for Fourth Quarter and Full Year 2012

WEST CHESTER, Ohio – January 7, 2013 – AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation systems for the treatment of atrial fibrillation, or AF, and systems for the exclusion of the left atrial appendage, in anticipation of investor meetings in San Francisco during the week of January 7, is announcing preliminary financial results for fourth quarter and full year 2012.

Preliminary revenue for the fourth quarter of 2012 is expected to be approximately $18.4 million, reflecting growth of approximately 9.5% over the fourth quarter of 2011. Based on these preliminary estimates, revenue from U.S. customers is expected to be $13.7 million, reflecting growth of 10.2%, and revenue from international customers is expected to be $4.7 million, reflecting growth of 7.7%, or 10.0% on a constant currency basis.

Preliminary revenue for full year 2012 is expected to be $70.2 million, reflecting year over year growth of 9.1% over full year 2011.

“We are pleased to report preliminary fourth quarter and full year 2012 results which provide a strong growth platform from which we can continue to build. In my first two months at AtriCure, I have spent considerable time evaluating the strategic and operational aspects of the company through in depth conversations with employees, clinical partners, customers, and shareholders. I have found many strengths – we have truly differentiated technology, solid customer relationships, an unparalleled training program, and a talented and committed group of employees. In 2013, in order to drive sustainable revenue growth, we will have additional focus on our commercial platform, strategic marketing effort, and our financial and operational discipline,” said Mike Carrel, President and Chief Executive Officer of AtriCure.

Mr. Carrel continued, “I am confident in our ability to further develop and expand the field of atrial fibrillation and position AtriCure to achieve its full potential, creating value for customers and shareholders. I look forward to providing additional detail on our growth strategy when we release our final 2012 results in late February.”


About AtriCure, Inc.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue for the treatment of atrial fibrillation, or AF, and systems for the exclusion of the left atrial appendage. The Company believes cardiothoracic surgeons are adopting its ablation products for the treatment of AF during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. The FDA has not cleared or approved certain AtriCure products for the treatment of AF or a reduction in the risk of stroke.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as earnings estimates, other predictions of financial performance, launches by AtriCure of new products and market acceptance of AtriCure’s products. Forward-looking statements are based on AtriCure’s experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond AtriCure’s control. These risks and uncertainties include the rate and degree of market acceptance of AtriCure’s products, AtriCure’s ability to develop and market new and enhanced products, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCure’s products, competition from existing and new products and procedures or AtriCure’s ability to effectively react to other risks and uncertainties described from time to time in AtriCure’s SEC filings, such as fluctuation of quarterly financial results, reliance on third party manufacturers and suppliers, litigation or other proceedings, government regulation and stock price volatility. AtriCure does not guarantee any forward-looking statement, and actual results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Presentation
Investor Presentation
January 2013
Exhibit 99.2


1
Forward Looking Statements
Non-GAAP Measures
This
presentation
contains
“forward-looking
statements”
within
the
meaning
of
the
Private
Securities
Litigation
Reform Act of 1995. Forward-looking statements include statements that address activities, events or
developments
that
AtriCure
expects,
believes
or
anticipates
will
or
may
occur
in
the
future,
such
as
earnings
estimates, other predictions of financial performance, launches by AtriCure of new products and market
acceptance of AtriCure’s products. Forward-looking statements are based on AtriCure’s experience and
perception of current conditions, trends, expected future developments and other factors it believes are
appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are
beyond AtriCure’s control. These risks and uncertainties include the rate and degree of market acceptance of
AtriCure’s products in the United States, AtriCure’s ability to develop and market new and enhanced products, the
timing of and ability to obtain and maintain regulatory clearances and approvals for its products and the impact of
failure to obtain such clearances and approvals on its ability to promote its products and train doctors in the use
of its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCure’s products and
the potential impact of current healthcare reform initiatives thereon, competition from existing and new products
and procedures or AtriCure’s ability to effectively react to other risks and uncertainties described from time to
time
in
AtriCure’s
SEC
filings,
such
as
fluctuation
of
quarterly
financial
results,
reliance
on
third
party
manufacturers and suppliers, litigation or other proceedings (including by the FDA), government regulation,
negative publicity, current worldwide economic conditions and stock price volatility. AtriCure does not guarantee
any forward-looking statements, and actual results may differ materially from those projected. Unless required
by
law,
AtriCure
undertakes
no
obligation
to
publicly
update
any
forward-looking
statement,
whether
as
a
result
of new information, future events or otherwise. A list and description of risks, uncertainties and other matters
can be found in AtriCure’s Annual Report on Form 10-K for 2010 and in AtriCure’s reports on Forms 10-Q and 8-K.
This presentation includes the use of non-GAAP measures, which are noted with a *.  Reference AtriCure’s 8-K’s
filings which include the furnishing of our earnings releases for a reconciliation to the related GAAP measure.


2
AtriCure Highlights
New leadership November 2012
Focus on accelerating growth, commercial execution, R&D innovation
Large underpenetrated market with few sustainable treatment options
Undisputed market leader in all types of surgical ablation
Broad and deep product portfolio
Strong IP in the field of AF
Strongest brand –
recognized for high-quality and innovative products
Leading KOL support and enthusiasm
Accelerating
revenue
growth
see
path
to
15%+
growth
Open
only
AF
label
for
surgical
ablation
Minimally
Invasive
Solutions
(MIS)
Largest
long-term
market
Left
Atrial
Appendage
(LAA)
Management
Solution
Danger
Zone….Opportunities
International Expansion 
Improve share and enter new markets
Opportunity
for
expanding
gross
margins
see
path
to
75%+


3
AtriCure at a Glance –
Strong Track Record
Surgical ablation leader for the treatment of atrial fibrillation (AF)
Over 100,000 Open procedures in >700 medical centers
Over 10,000 MIS procedures in ~130 medical centers
Leader in implants designed to exclude left atrial appendage (LAA)
Over 14,000 safely and effectively implanted
100+ peer-reviewed publications highlighting product results
Significant key opinion leader (KOL) support
Global innovator with comprehensive product line
AtriCure
Synergy
Ablation
System
bipolar
ablation
clamp
system
Cryoablation –
reusable and disposable cryoablation devices
AtriClip –
designed to safely and effectively exclude the LAA
Experienced Sales Force
Over 40 US territories led by eight managers
Preliminary
2012
Revenue
-
$70.2
million
Expected Growth of ~9% y/y


4
AF Population:  Large, Growing & Undertreated
(1)Miyasaka Y, et al. Circulation. 2006;114(2):119-125.
(2)Lloyd-Jones D, et al. [published online ahead of print December 17, 2009].
Circulation. doi:10.1161/CIRCULATIONAHA.109.192667.
(3)Lloyd-Jones DM, et al. Circulation. 2004;110(9):1042-1046.
(4)  Fuster V, et al. J Am Coll Cardiol. 2001;38(4):1231-12665
(5)
Benjamin EJ, et al. Circulation. 1998;98(10):946-952.
(6)
Kim M, et al. Circ Cardiovasc Qual Outcomes. 2011;
4:313-320
AF affects over 5
million in the U.S.
(1)
Significant costs to
healthcare system
U.S. prevalence projected to grow to 12-15 million by 2050
International prevalence is comparable to the U.S.
Most
common
sustained
cardiac
arrhythmia
(2)
Lifetime
risk
of
AF:
~1
in
4
for
adults
40
years
of
age
(3)
AF increases 5-fold
the
risk
of
stroke
(4,5)
AF
is
leading
cause
of
stroke
over
15%
in
US
linked
to
AF
(5)
AF
results
in
early
mortality
and
cause
of
stroke
in
elderly
(4)
AF-related strokes are more severe
(5)
Issues with non-
surgical treatment
of AF
Warfarin drug therapy has complications
Anti-arrhythmic drugs often not well-tolerated and ineffective
< 3% of AF patients are treated with catheter or surgical
ablation
Direct
medical
costs
are
~73%
higher
in
AF
patients
(6)
Net
incremental
cost
of
$8,705
per
patient
per
annum
(6)
U.S.
annual
incremental
cost
of
AF
is
~$26.0
billion
(6)


5
Atrial Fibrillation U.S. Market Opportunity
Labeling advantage in US
Best products
High gross margins
Education key
Competition is large device
High reimbursement
High gross margins
Growing internationally
Development needed
Competition is start-ups
AtriCure is the only
on-label product
Developing Market
Market
Opportunity,
$370M
Current
Market,
$130M
Market
Opportunity,
$3.9 billion
Current
Market,
$40M
Open
Surgical
Patient
Opportunity, 
100,000
Untreated
or
Managed
with
Drugs,
2.3
Million
MIS/Stand-
Alone
Patient
Opportunity, 
600,000
MIS Market
Open Surgical Market
3-5 Million Patients in U.S. with AF


Left Atrial Appendage U.S. Market Opportunity
Mechanical, Electrical,
Atraumatic; Solution
Competition includes Tiger
Paw, staple, suture,
ligature (endloop) –
NO
Complete Solution
Attractive sole therapy
reimbursement
Competition includes
implants and EP closure
(w/o FDA approval)
AtriCure has more
implants than
competition (14K+)
~1M U.S, LAA Patients
LAA (Concomitant)
LAA
(Concomitant) 
100,000
patients
LAA
(Sole Therapy) 
~750,000
patients
Market
Opportunity,
$100M
Current
Market,
$10M
Current
Market,
$32M
Market
Opportunity,
$1.5B
LAA ( Sole Therapy)
6


7
AtriCure Business Overview
Focus Areas
2012
Growth
Market
Size ($M)
Keys to Success
Current
Trials
Open AF
(Concomitant)
+13%
$500M
Education; referral dev.; Reimbursement;
awareness; conversions; add-on sales
PAS
MIS AF Sole
Therapy
-11%
$4,000M
Referral development; new products; hybrid;
surgeon proctoring; development of less invasive
approach (products and procedures)
Staged DEEP
Open Clip
(Concomitant)
$100M
Market awareness; open growth; overcoming
cost argument; stroke RCT
Papers
Clip Sole
Therapy
New ’13
$1,500M
Market awareness; international; eliminating
complications; supporting early adopters; referral
development; prominent KOLs; stroke RCT
Papers
International
+14%
Same as US
Market development; reimbursement; coverage;
marketing; customer service
Involvement
Above
Overall
+9%
$12,000M
Investments in marketing, international, R&D
pipeline
+26%


8
Growth Strategy:  Overview
Expand Open-Heart Sales
Penetrate LAA Opportunity
Build MIS Platform
International Expansion
Leverage recent AF indication
Increased training and education
Capitalize on sales force realignment
and AF Strategic Marketing Team
Capitalize on cross-sale opportunities
resulting from AF labeling
Capitalize on increased investments in
direct sales team
Geographic expansion and new products
Increase support for distributors
Penetrate open-heart ablation centers
Featured in our training and education
for open-heart
FDA approved for use in DEEP AF trial
Longer-term: commercialization of sole-
therapy platform
Support existing MIS surgeons
Support staged DEEP AF trial
AtriCure
is
the
only
company
with
FDA
approval
to
treat
the
AF
disease
state
and
is a leader in the emerging market of LAA exclusion


9
Growth Strategy:  Expand Open-Heart Sales
FDA approved the AtriCure Synergy
Ablation System for treatment of non-
paroxysmal Atrial Fibrillation in
patients undergoing other structural
heart procedures (December 2011)
Only surgical ablation system that
has received FDA indication
AtriCure can partner with surgical AF
leaders to provide comprehensive
training and support
Support “on-label”
surgeon training
and education
Improves safety and efficacy
Increases surgeon confidence
Reduces operative time
Actively increase market awareness
Competitive account conversions
FDA Approval
Leveraging FDA Approval


10
Growth Strategy:  Expand Open-Heart Sales
Significant
progress
in
both
surgeon
and
site
certification
all
achieved
in
a
9
month
period (18 month program)
Expectation that revenue for all accounts trained will be consistent with these results
Significant competitor conversions during 2012
Surgeons Certified
Sites Certified
609
1,000
359
500
-
200
400
600
800
1,000
9 Month Progress
18 Month Goal
9 Month Progress
18 Month Goal


11
Growth Strategy:  Build MIS Platform
Leverage HRS consensus statement
AF Centers of Excellence
AtriCure Maze IV surgeon post training
marketing programs
AF Awareness Campaign focused on
surgical options
Sole therapy clinical trials spur interest
in surgical AF
Product launches
Coolrail
re-launch
October
2012
AtriClip
Pro
launch
October
2012
DEEP AF / Staged DEEP AF IDE
Feasibility Trial
Randomized CA vs. MIS PCORI Study
Submission (Ellenbogen)
Support academic papers
Build Clinical Evidence
Strategic Initiatives


12
Growth Strategy:  Penetrate LAA Opportunity
14,000+ AtriClips implanted:
No reported erosions
No clip migration
No leakage
Mechanical closure reduces nidus for AF-
related emboli
Electrically isolates the appendage,
reduces source for ectopic firing
AtriCure has first 510(k) device clearance
for LAA specific exclusion device
EXCLUDE 510(k) trial demonstrated 98% of patients with complete closure at three
month endpoint and zero device-related serious adverse effects
Efficacy
Safety
Safety & Efficacy of Open and MIS AtriClip products is Well-Established


13
Growth Strategy: Penetrate LAA Opportunity
Most prevalent and life-threatening
complication of AF is stroke
LAA is the site of more than 90% of
detected thrombi in AF patients
(1)
Atritech Watchman PROTECT AF clinical
trial results confirms LAA exclusion
reduces AF related stroke 
The 2006 AHA/ACC/ESC guidelines:
“The LAA should be removed from
circulation when possible during
cardiac surgery in patients at risk of
developing postoperative AF”
Conventional surgical techniques for
exclusion are suboptimal
(3)
60% of closures were unsuccessful
41% with unsuccessful LAA exclusion
had thrombus in LAA
15% with unsuccessful closure had
evidence of stroke or TIA
Growing patient awareness created by Big
Pharma
Reimbursement code established for sole
therapy LAA exclusion
(1)
Blackshear
(2)
Am J Med, vol. 114, Penado et al. 2003
(3)
(1) Kanderian, MD, Anne S., A. Marc Gillinov, MD, Gosta B. Pettersson, MD, PHD, Eugene Blackstone, MD, and Allan L. Klein, MD, FACC.
"Success of Surgical Left Atrial Appendage Closure." JACC. 52.11
(2008): 924-9. Print.
Cumulative
Stroke
Recurrence
Rate
(2)
LAA Exclusion Market Drivers
Significant Risks Associated with LAA


14
Growth Strategy:  International Expansion
EMEA office based in Amsterdam with infrastructure to support commercial activities
Direct sales in Germany, Switzerland
(1)
, Austria, Benelux and the UK in 2013
Exclusive country distributors in other regions
(1)
Sales agent
Amsterdam
Cincinnati
South America
Distributor
relationships:
Canada
Asia Pacific
Distributor relationships:
Europe
China
Hong Kong
Japan
Korea
Thailand
Malaysia
Singapore
India
Australia /
New Zealand
Taiwan
Brazil
Colombia
Chile
Mexico
Argentina
Costa Rica
Distributor relationships:
Italy
Spain
Denmark
Poland
Portugal
Sweden
Turkey
Czech  
Republic
Greece
Norway
Russia
South Africa
Middle East
Distributor
relationships:
Pakistan
Saudi Arabia


15
Growth Strategy:  International Expansion
$6.4
$8.3
$10.5
$11.5
$15.5
$17.6
International
Revenue
By
Region
(2007
2012)
$3.4
$4.5
$5.4
$6.6
$8.7
$10.3
$2.7
$3.4
$4.6
$4.5
$6.3
$6.7
$0.4
$0.4
$0.5
$0.4
$0.5
$0.6
-
$2.0
$4.0
$6.0
$8.0
$10.0
$12.0
$14.0
$16.0
$18.0
$20.0
2007
2008
2009
2010
2011
2012
EMEA
Asia
ROW
$
Benelux,
20%
Germany,
15%
UK, 9%
Other
EMEA,
14%
Japan,
22%
China,
13%
Other
Asia, 4%
ROW, 3%
International sales growing rapidly – 25% of total revenue


16
Key Financial Highlights
Opportunity for…
Accelerating revenue growth to 15%+ (8% 5yr. CAGR today)
Expanding Gross Margins to over 75% (71% today)


17
AtriCure Highlights
New leadership since November 2012
Focus on accelerating growth, commercial execution, R&D innovation
Large underpenetrated market with few sustainable treatment options
Undisputed market leader in all types of surgical ablation
Broad and deep product portfolio
Strong IP in the field of AF
Strongest brand –
recognized for high-quality and innovative products
Leading KOL support and enthusiasm
Accelerating
revenue
growth
see
path
to
15%+
growth
Open
only
AF
label
for
surgical
ablation
Minimally
Invasive
Solutions
(MIS)
Largest
long-term
market
Left
Atrial
Appendage
(LAA)
Management
Solution
Danger
Zone….Opportunities
International
Expansion
Improve
share
and
enter
new
markets
Opportunity
for
Expanding
Gross
Margins
see
path
to
75%+


Appendix


19
Broadest Product Portfolio
Probes/Pens
Synergy
Cryoablation
AtriClip
Workhorse ablation system
Completely automated
Rapid: 10-30 second ablations
Used in Open and MIS
Deepest unidirectional lesion formation
Totally thoracoscopic design 
Simple user interface
Clip
easily
be
repositioned
MIS
and
Open
Fabric prevents slippage, promotes in-growth
Appendage atrophies away
Used for LAA
Faster and More consistent to achieve lethal
probe temperature
Only probe with Defrost feature
Greatest work capacity in cryo probe market


20
Robust Product Pipeline
AtriClip
RF Ablation
Cryoablation
Long Linear Ablation
One-sided approach to perform
Pulmonary Vein Isolation
Improved safety and efficacy
over competitive devices
Next
Generation
AtriClip
-
BOA2
Tailored to most difficult and
challenging access
Launched 3Q 2012
Reusable Clip Deployment
Reusable Platform
Lower cost clip option
Next Generation AtriClip and
AtriClip –
ACH2
Improved access via malleable
shaft and in-line design
Open-ended clip design
Cryo Console Adapter Box-AAM
Next Generation Cryo-
CRYO2A
Increased Malleability
Next Generation RF & Cryo
Generators
Improved usability and branding
Increased capabilities to support
future platforms
Ability to use re-usable cryo
platform with automated
cryo module (ACM)
Current status:
94 active product versions and 153 active product codes


21
Blue Chip Customer Base
Top 10 “Heart Hospitals”
U.S. News & World Report
Top 25 “Heart Hospitals”
U.S. News & World Report
Top 50 “Heart Hospitals”
U.S. News & World Report
Representative Blue Chip Customers
AtriCure
Hospitals,
100%
Non-
AtriCure
Hospitals,
4%
AtriCure
Hospitals,
96%
Non-
AtriCure
Hospitals,
18%
AtriCure
Hospitals,
82%