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| 8-K - CURRENT REPORT - ANGIODYNAMICS INC | an26380416-8k.htm |
| EX-99.1 - PRESS RELEASE - ANGIODYNAMICS INC | an26380416-ex99_1.htm |
EXHIBIT 99.2
FORWARD-LOOKING STATEMENTS
Notice Regarding Forward Looking Statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements
regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital
expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as
statements that include the words such as “expects,” “reaffirms” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “optimistic,” or
variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future
performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’
expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the ability of AngioDynamics to
develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory
agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic
conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market
acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of
AngioDynamics to integrate purchased businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but
not limited to its Annual Report on Form 10-K for the year ended May 31, 2011 and its Quarterly Report on Form 10-Q for the fiscal quarters ended
November 30, 2011 and February 29, 2012. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking
statements for any reason.
regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital
expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as
statements that include the words such as “expects,” “reaffirms” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “optimistic,” or
variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future
performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’
expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the ability of AngioDynamics to
develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory
agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic
conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market
acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of
AngioDynamics to integrate purchased businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but
not limited to its Annual Report on Form 10-K for the year ended May 31, 2011 and its Quarterly Report on Form 10-Q for the fiscal quarters ended
November 30, 2011 and February 29, 2012. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking
statements for any reason.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. NanoKnife has not been cleared for the
treatment or therapy of a specific disease or condition. This document may discuss the use of NanoKnife for specific clinical indications for which it
is not cleared in the United States at this time.
treatment or therapy of a specific disease or condition. This document may discuss the use of NanoKnife for specific clinical indications for which it
is not cleared in the United States at this time.
Notice Regarding Non-GAAP Financial Measures
Q4 and FY 2012 Investor Call
July 12, 2012
Q4 and FY 2012 Investor Call
July 12, 2012
AngioDynamics, the AngioDynamics logo and other trademarks displayed in this presentation are trademarks owned and used by AngioDynamics, Inc. © Copyright 2012 AngioDynamics, Inc. All rights reserved.
4
AGENDA
Integration Update
Quality Call to Action Update
Outlook for FY 2013 and Beyond
Q4 Accomplishments
Q4 and FY 2012 Review
5
Q4 ACCOMPLISHMENTS
• Closed acquisition of Navilyst; Integration on schedule
• Grew VenaCure EVLT™ 17%
• Grew NanoKnife® 54%
• Grew International business 22%(1)
• Published two new NanoKnife® studies
• Commenced Microsulis international distribution agreement
• Launched Embarc™ microcatheter and Charter guidewire
• Signed 3 yr contract with HealthPRO, Canada’s largest GPO, due to BioFlo™
• Hired new CTO
(1) Constant currency and excluding Navilyst.
6
• Significant pre-closing planning effort paying off
• $5-7 million in FY13 cost savings accomplished
• Most organizational changes completed
• Management team now in place - best talent from both organizations
o New CTO
o New Head of Quality
• Creation of three global businesses to achieve greater focus on customers and markets
INTEGRATION UPDATE
o New Head of Regulatory
o New Head of US Sales
Announcement
Jan 31, 2012
Remainder of
FY13
ü Integration Leadership Office created
ü External consultant retained
ü Significant joint planning conducted
ü $5-7M FY13 synergies validated
ü Prelim org realignment developed
ü 100 day post-closing plan created
q ERP Implementation
q Consolidated global QMS
q Functional shared service consolidation
q Accelerated ops excellence activities
q Ongoing synergy capture
q Rollout of brand refresh
~Day 50
TODAY
Closing
May 22
ü Flawless Day 1 transition
ü S&M org changes implemented
ü G&A org changes implemented
ü CTO hired
ü U.S. & Int’l sales meetings conducted
ü Creation of 3 global businesses
o New Head of Queensbury Manufacturing
o New Medical Director
7
• Up to date on all QCTA objectives and commitments to the FDA
• Significantly improved quality capabilities through acquisition of Navilyst
QUALITY CALL TO ACTION UPDATE
COST AND GROSS MARGIN IMPACT OF QCTA & PRODUCT RECALLS
¯ 2.6%
Impact
on GM%
on GM%
¯ 2.5%
¯ 4.3%
Impact
on GM%
on GM%
Impact
on GM%
on GM%
¯ 1.4%
¯ 0.6%
Impact
on GM%
on GM%
Impact
on GM%
on GM%
8
Q4 REVIEW
9
FY 2012 REVIEW
10
FY 2012 PRO FORMA OPERATING RESULTS
Pro Forma Operating Results:
•Include Navilyst as if combined for all of FY
2012
2012
•Exclude LC Beads and related S&M costs
•Exclude acquisition, restructuring,
financing, QCTA and product recall costs
financing, QCTA and product recall costs
11
The angiodynamics
Mission
A NEW DAY FOR ANGIODYNAMICS…
Vascular
Access
VA
Peripheral
Vascular
PV
Oncology/
Surgery
O/S
• BioFlo™ as a platform technology
• Advanced techniques and procedures
• New technologies
• Automated Fluid Management
• Comprehensive venous strategy
• Thrombolysis/Thrombectomy/PE
• Next generation venous ablation
• NanoKnife® Standard-of-Care
• Microwave
• Interventional Oncology
Three Global Businesses
Focused on Innovation
Focused on Innovation
• Develop innovative, differentiated and high
quality products for clinicians and patients
quality products for clinicians and patients
• Focus our investments in product categories
and geographic markets that offer
sustainable, profitable growth
and geographic markets that offer
sustainable, profitable growth
• Enhance our profitability by driving operation
excellence across the entire organization
excellence across the entire organization
Grow revenues 8-10%
Grow earnings at a mid teens rate
Long-term Financial
Objectives
12
FY13 OUTLOOK FOR OUR GLOBAL BUSINESSES
13
PERIPHERAL VASCULAR BUSINESS
Reinvigorate
NAMIC
NAMIC
Expand
Ablation
Grow
Core
PV
• Channel Synergy
- Fluid Mgmt in IR/Vascular
- Venous Ablation in Cardiology
- Core Products in Cardiology
• NeverTouch Direct™ Launch
+
=
FY 2013
Strategic
Objectives
Key Growth
Drivers
Financial
Expectations
(1) Pro Forma sales exclude LC Beads and include Navilyst as if combined for all of FY12.
14
VASCULAR ACCESS BUSINESS
Penetrate &
Convert
Convert
BIOFLO BIOFLO
BIOFLO
BIOFLO
VA
• BioFlo™ PICCs
(pending 510(k) clearance)
(pending 510(k) clearance)
• BioFlo™ Ports
(pending 510(k) clearance)
(pending 510(k) clearance)
• BioFlo™ Dialysis
(pending 510(k) clearance)
(pending 510(k) clearance)
• Strategic Acquisitions
+
=
FY 2013
Strategic
Objectives
Key Growth
Drivers
Financial
Expectations
(1) Pro Forma sales exclude LC Beads and include Navilyst as if combined for all of FY12.
15
BIOFLO™ TECHNOLOGY
Coatings
Impregnated
(in the pores)
Current Next Generation PICC Technologies
NO HEPARIN
NO ANTIBIOTICS
NOT A COATING
NOT ELUTING
Minimizes complications associated w/ heparin
Reduces risks associated w/ bacterial resistance
Present throughout entire catheter
Present for life of device
Unlike other technologies
that are superficial and/or
transient, BioFlo is designed
to be both integral to the
catheter and permanent
that are superficial and/or
transient, BioFlo is designed
to be both integral to the
catheter and permanent
The BioFlo™ Advantage…
VA
NOTE: BioFlo is pending 510(k) clearance in the U.S. Approved in Canada and CE Marked.
16
BIOFLO™ TECHNOLOGY (cont’d)
Head-to-Head
BARD PowerPICC Solo2®
vs.
BioFlo™ with PASV® PICC
|
Metric
|
PowerPICC Solo 2
|
BioFlo w/ PASV
|
|
PICCs Placed
|
60
|
133
|
|
Occlusion Rate
|
9.63/1,000 catheter days
|
4.96/1,000 catheter days
|
|
T-PA Usage Rate
|
12.84 doses/1,000 catheter days
|
7.93 doses/1,000 catheter days
|
|
DVT Rate
|
0.80/1,000 catheter days
|
0.50/1,000 catheter days
|
BioFlo™ Demonstrated:
VA
• 48% reduction in occlusions
• 38% reduction in t-PA use
• 37% reduction in DVT
NOTE: Preliminary retrospective data analysis conducted outside the U.S. by independent investigator. BioFlo is pending 510(k) clearance in the U.S.
Approved in Canada and CE Marked.
Approved in Canada and CE Marked.
Early Customer Evaluation of BioFlo™
17
ONCOLOGY / SURGERY BUSINESS
Drive NanoKnife
Adoption
Adoption
Deliver the Most
Comprehensive
Ablation Solution
Comprehensive
Ablation Solution
O/S
• NanoKnife® Data
• International Microwave
• Embarc™ Microcatheter and
Charter™ Guidewire launches
Charter™ Guidewire launches
• Strategic Transactions
+
=
FY 2013
Strategic
Objectives
Key Growth
Drivers
Financial
Expectations
Continue to Fill
Channel
Channel
(1) Pro Forma sales exclude LC Beads and include Navilyst as if combined for all of FY12.
18
NANOKNIFE® PROPOSED PANCREATIC IDE TRIAL
HEAD-TO-HEAD EVALUATION
Gemcitabine
vs.
NanoKnife®
+ Gemcitabine
in patients with uncresectable
pancreatic cancer
pancreatic cancer
• Randomized controlled trial
• Comparison vs. standard-of-care (gemcitabine)
• 190 patients w/ confirmed stage III disease
• Primary endpoint: local PFS
• Secondary endpoints: response rate, QOL, VAS
• Expected start date: 1H FY13
• Enrollment: ~24 months
O/S
19
Oncology/
Surgery
Peripheral
Vascular
Vascular
Access
A NEW U.S. GO-TO-MARKET STRATEGY
VP Sales
Area
Sales
Director
Sales
Director
VA
Sales Rep
PV
Sales Rep
O/S
Sales Rep
Regional/
Specialized
Selling Teams
Selling Teams
U.S. Commercial Ops
Global Businesses
Customers
GPOs
Unified
Sales
Mgmt
IHN/IDN
Hospitals
CEOs/CFOs/
Purchasing Managers
Doctors
IRs/ICs/
Surgeons/Nurses
VA
Specialist
PV
Specialist
O/S
Specialist
Clinical Specialists
Regional
Managers
20
FY13 FINANCIAL GUIDANCE
Key FY13 Objectives
• Drive sales synergies with new
call points and more focused
sales efforts
call points and more focused
sales efforts
• Meet/exceed cost saving goals
by aggressively implementing
the integration program
by aggressively implementing
the integration program
• Strong product launches of
BioFlo™ in the U.S., NeverTouch
Direct®, Microsulis and
microcatheters
BioFlo™ in the U.S., NeverTouch
Direct®, Microsulis and
microcatheters
• Make tuck-in acquisitions to
accelerate sales and earnings
growth
accelerate sales and earnings
growth
(1) Pro Forma operating results (i) exclude LC Beads and related S&M costs, (ii) exclude acquisition, restructuring, finance, QCTA and product recall costs
and (iii) include Navilyst as if combined for all of FY12.
and (iii) include Navilyst as if combined for all of FY12.
21
FINANCIAL ASPIRATIONS FOR FY14 AND BEYOND
Key Long-term Objectives
•NanoKnife as standard of care
•Continue to introduce innovative
products and technologies, including
automated fluid management
systems, next-generation ablation
solutions and venous intervention
products
products and technologies, including
automated fluid management
systems, next-generation ablation
solutions and venous intervention
products
•Sustained international expansion
and penetration
and penetration
•Realization of longer-term
operational excellence initiatives
operational excellence initiatives
Q4 and FY 2012 Investor Call
July 12, 2012
AngioDynamics, the AngioDynamics logo and other trademarks displayed in this presentation are trademarks owned and used by AngioDynamics, Inc. © Copyright 2012 AngioDynamics, Inc. All rights reserved.
23
APPENDICES
Business Development Summary:
• 18 active discussions 1
- $750M- $1.5B of cumulative 5-yr sales
• Relatively balanced portfolio
- Stage of development:
Ø 8 (45%) Commercial; 10 (55%) R&D 1
- Business Focus:
Ø 8 (45%) Vascular; 10 (55%) Oncology 1
• Most Oncology targets are fairly small
- $350M - $500M of cum. 5-yr sales
- Only Microsulis >$50M of cum. 5-yr sales
>> Reconciliation Tables
24
Reconciliation of Net Income to non-GAAP Net Income
- Only Microsulis >$50M of cum. 5-yr sales
25
Reconciliation of Diluted Earnings (Loss) Per Share to Non-GAAP
Diluted Earnings Per Share
Diluted Earnings Per Share