Upload
lydien
View
214
Download
0
Embed Size (px)
Citation preview
Certain statements in this slide presentation constitute “forward-looking statements”within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Some of these statements relate to estimated future revenue, gross margins and earnings per share, estimated market potential and the continuing impact from the results of the AiMI trial. These statements are based on our current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements such as the effectiveness of our sales and marketing efforts in re-establishing coronary product usage, our ability to secure favorable distribution partnerships, our ability to effectively introduce and market new products, success in obtaining new regulatory approvals and clearances, impact of competition and our ability to generate suitable clinical registry data to support growing use of the AngioJet System and our other endovascular products. A discussion of these and other factors that could impact the Company’s future results are set forth in the cautionary statements included in Exhibit 99 to the Company’s Form 10K for the year ended July 31, 2006, filed with the Securities and Exchange Commission.
Forward-Looking Statements
Public: NASDAQ Global Select Market: POSSRussell Micro-cap IndexS&P Small Cap 600
Stage: Profitable Small-cap
Business: Medical Devices
Markets: Endovascular Mechanical Thrombectomy, Embolic Protection/Temporary Occlusion, Access Site Hemostasis
Location: Minneapolis, Minnesota
Employees: 288, including 87 direct U.S. sales
Possis Facts
U.S. Sales Structure
• 9 U.S. Regional Sales Managers
• 34 Sales Representatives
• 44 Clinical Sales Representatives
Regional Sales Managers
Sales Representatives
Clinical Sales Representatives
SYMBOLPOSITION
U.S. Sales Force
• Endovascular intervention encompasses entire vascular system
• Saves thousands of lives and limbs using cutting-edge technologies
$11 Billion Dollar Industry
• Interventional Cardiologists
• Interventional Radiologists
• Vascular Surgeons
• Interventional Neuro-radiologists
• Interventional Nephrologists
Medical Specialties
Medical Facilities
And thousands more worldwide
Conducting procedures in over 3,000 facilities in the U.S.
• Aging population- Each day during the next 20 years approximately 13,000 people will turn 60 years old
• Technological advancements
• Increased adoptionof intervention
Growing Market
Vascular Disease and Intra-vascular Blood Clots in U.S. Patients
#1 Killer in America
Coronary Heart Disease: 2.6 millionPeripheral Vascular Disease (PVD): 2.5 million
Dialysis Treatment: 320,000
Neurologic Ischemia (stroke): 600,000
Pulmonary Embolism: 200,000
Narrowing of the artery causedby vascular disease (plaque)
-Plaque-Thrombus-Ischemia
Defining The Problem
Blood clot obstructsblood flow (Thrombus)
Narrowing of the artery causedby vascular disease (plaque)
-Plaque-Thrombus-Ischemia
Defining The Problem
Blood clot obstructsblood flow (Thrombus)
Endovascular interventionto restore blood flow
Narrowing of the artery causedby vascular disease (plaque)
-Plaque-Thrombus-Ischemia
Defining The Problem
• 31 U.S. patents
• 6 Non-U.S. patents
• 25 U.S. patent applications
• 35 Non-U.S. patent applications
• Considerable portfolio of trade secrets
Strong Proprietary Protection
• Largest provider of mechanical thrombectomy
• Most advanced endovascular therapy for treatingintra-vascular blood clots
• FDA Indications for Coronary, Peripheral Arterial, Peripheral Venous and AV Access use
• DRG and CPT (reimbursement) codes for all four markets
Mechanical Thrombectomy Leader
Market Leader
328,000 patients treated
Cumulative Catheters Sold
6,538 15,23831,196
56,586
89,993
132,610
184,582
233,859
280,640
327,981
FY98 FY99 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07
Lab Penetration
• Over 2,100 AngioJet® Systems placed worldwide• Used in 95% of largest U.S. coronary labs
Drive Units Placed
1,822
2,144
1,6451,465
1,210
863
669
443300
191
FY98 FY99 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07First Gen Ultra
> 244 Ultra
• Robust business model fueled by a gross profit margin of 70 percent
• Non-GAAP (excl. Stock based comp.) profitability for 26 consecutive quarters
• Strong balance sheet with $43 million in cash and cash equivalents and no long-term debt
Financial Strength
1952-1960 Private, Industrial Products
1960-1976 Public, Industrial Products
1976-1993 Industrial & Medical Products
1994-2001 Development Stage Medical Products
2002-2004 Profitable, High Growth Mechanical Thrombectomy
2005-2006 Profitable, Clinical Study Impacts Coronary Growth
Our Future Return to High Growth, Endovascular Treatment
History
AiMI Study-Valuation Impacting Event
2006Fourth Quarter Employees Meeting
August 2004
A study designed for market expansion created a falseperception:
-AngioJet less effective than standard therapy in treating STEMI patients
-New safety concern with AngioJet in treating STEMI patients
AiMI- Likely An Anomaly
• Recently published real-world experience further confirms safety and efficacy of AngioJet thrombectomy for coronary use
• AiMI study control an anomaly
Journal of Invasive Cardiology
– July 2006
Confidence in Strength
Dedicated People Dedicated People Core Technology Core Technology
FDA Approved ProductsFDA Approved ProductsFinancial StabilityFinancial Stability
The strengths of Possis are focused on thrombus management and endovascular treatment products
• Coronary sales declined 40 percent from peak in fiscal 2004
• Turnover of 45 percent in sales personnel
• Revenue declined to $62 mil. in fiscal 2006 vs. $72 mil. in fiscal 2004
• Non-GAAP (excl. stock based comp.) pre-tax income declined to $6 mil. in fiscal 2006 vs. $18.8 mil. in fiscal 2004
• Stock price declined from high of $34 per share to under $8 per share
The Bad and The Ugly
• Stabilized coronary sales; JIC publication shows AngioJet therapy safe and effective and finds AiMI study control to be an anomaly
• Invested heavily in new products and product labeling: DVX, XMI-RX+, Spiroflex, Spiroflex VG, GuardDog, Fetch, Venous FDA clearance, ULTRA
• Doubled peripheral product sales
• Introduced SafeSeal™ Hemostasis Patch into $45 mil. access site hemostasis market
• Generated new clinical science and intiated new studies; Dr. Sianos, JETSTENT, STEMI meta-analysis and PEARL registry
The Good
• Maintained firm pricing, maintained gross profit margin low to mid 70 percent and remained profitable
• Expanded placed drive units from 1465 in fiscal 2004 to 1822 in fiscal 2006
• Revitalized and strengthened our US sales force
• Secured CPT code reimbursement for AngioJet use in peripheral arteries and veins
• Cash and cash equivalents remained strong at $48 mil. in fiscal 2006 vs. $48 mil. in fiscal 2004 while repurchasing $27.2mil. in Possis stock and investing heavily in R&D
The Good
Possis Valuation History
2.5x1.5x2.4x6.5xEV / Revenue
$186$95$158$474Entity Value (EV)
$229$143$203$522Market Cap.
16.917.117.318.3 Shares Outstanding
$13.53$8.36$11.70$28.60Market Price Per Share
2007200620052004
Sept. 19,July 31st
Note:
A) Shares, market cap, and EV in millions
B) EV = market cap – cash + debt
Entity Value (EV) Multiple*Comparable Vascular Companies
2.54.8
3.1 3.0 3.73.62.0
5.2
0.02.04.06.08.0
EV3
Kense
y Nas
h
Spectr
aneti
cs
Vascu
lar Solu
tions
Fox H
ollow
Group M
ean (
5 c...
Small C
ap C
ardio.
..
Possis
EV
/LTM
Rev
enue
*Multiple of calendar 2007 revenue est.
(Unte
rberg’
s 24 c
os.)
To be the worldwide leader in theendovascular treatment of intra-vascular thrombus and to be positioned to take
advantage of new opportunitiesbeyond this core business.
Vision
1. Increase adoption of AngioJet thrombectomy in our current mechanical thrombectomy markets(Coronary, PAO, AV Access)
Growth Strategies
Mechanical Thrombectomy Products
Realizable Market
Fiscal Year 2007
U.S. Market -- $440 mil.
AV AccessCoronary
Peripheral
Arterial
Possis leads with ~14% penetration
Majority of market remains untapped
Key Drivers:1. New and improved thrombectomy catheters
that improve performance and address unmet clinical needs
2. Improve AngioJet System ease-of-use
3. Provide increasingly compelling and current clinical data
4. Ensure appropriate reimbursement
Increasing AngioJet Adoption
Recent New Products Driving Adoption
Spiroflex® -PAO & Coronary
Spiroflex® VG-PAO & Coronary
Power Pulse™
Delivery
DVX®
AngioJet ULTRA Debuting in FY2007
Ultra Console
Thrombectomy Set(Catheter and pump)
FDA Approved and Full Market Launch!
• International JETSTENT study: a multi-center, prospective, randomized trial of AngioJet thrombectomy (200 patients enrolled)
• STEMI Meta-analysis of clinical outcomes following AngioJet treatment of thrombosed STEMI lesions
• PEARL registry; prospective, multi-center registry of Xpeedior & DVX catheters in real world (100+ patients enrolled)
• Dr. Sianos’s Thorax Centre study of AngioJet treatment prior to DES implantation ( JACC August 2007)
Ongoing & New Clinical Research
• Drug-eluting stent (DES) thrombosis is an ongoing, prominent concern in interventional cardiology
• Recent announcements from large DES manufacturer confirms higher rates of late DES thrombosis
• U.S. usage rate of DES has dropped from 90% to 60% of all stents
• Physicians focused on reducing risk
Drug-Eluting Stent (DES) Thrombosis
AngioJet Reduces Stent Thrombosis
Clinical research from The Thoraxcentre shows AngioJet Thrombectomy reduces incidence of DES thrombosis
No rheolytic thrombectomy
Rheolytic thrombectomy
P=0.011
8%11%
0%
Five new CPT codes provide for physician reimbursement of peripheral thrombectomy (arterial and venous)(January, 2006)
From $227 to $393 per treatment.
New Peripheral Reimbursements
1. Increase adoption of AngioJet thrombectomy in our current mechanical thrombectomy markets(Coronary, PAO, AV Access)
2. Expand AngioJet thrombectomyinto new markets (DVT, PE, Neurovascular)
Growth Strategies
• Currently U.S. market opportunity ~$90 million (60,000 procedures)
• Market penetration and growth require change in practice patterns (Anticoagulation Intervention)
• FDA indication and clinical science needed to fully capitalize on DVT market opportunity
-Venous 510(k) clearance received late November
Deep Vein Thrombosis (DVT)
• Currently estimate U.S. market opportunity to be ~$45 million (30,000 procedures)
• Market penetration and growth require change in practice patterns (Anticoagulation Intervention)
• FDA indication and clinical science needed to fully capitalize on PE market opportunity
Pulmonary Embolism (PE)
Expanding Opportunity
AngioJet Thrombectomy –More Market Segments – Larger Overall Opportunity
Fiscal Year 2007U.S. Market -- $440 mil.
AV AccessCoronary
Peripheral
Arterial
Fiscal Year 2010U.S. Market -- $675 mil.
AV AccessCoronary
Peripheral
ArterialPulmonary
Embolism
Deep Vein
Thrombosis
1. Increase adoption of AngioJet thrombectomy in our current mechanical thrombectomy markets (Coronary, PAO, AV Access)
2. Expand AngioJet thrombectomyinto new markets (DVT, PE, Neurovascular)
3. Market a growing catalog of thrombus management and other endovascular productsto our established customer network by leveraging our enterprisestrengths
Growth Strategies
• Established, effective distribution channel
• Regulatory competency and track record
• Medical device engineering and manufacturing expertise
• Active, expanding customer network (nearly 1800 sites)
• Brand recognition and marketplace credibility
• Robust business model and strong cash position
Growth Strategies
Leverage the Strengths of Our Enterprise
Thrombus Management• Adjunctive products to support AngioJet use
• Other thrombus management products that provide additional value
Growth Strategies
Key areas of focus:
Thrombus Management• Adjunctive products to support AngioJet use
• Other thrombus management products that provide additional value
Other Endovascular Products• New and/or underserved markets
• Capitalize on relationships and expertise of sales force
Growth Strategies
Key areas of focus:
Thrombus Management Products
GuardDOG® Occlusion System-restarted beta-launch of GD withimproved joint in Q4
• $2.5 mil. investment with option to acquire Rafael Medical
• Current market >$170 mil. $200 mil. + by 2010
• Currently under clinical study for 510(k) clearance
Thrombus Management Products
SafeFlo® IVC Filter
SafeFlo®
Retrievable IVC Filter
I.V.C Filter
Inferior Vena Cava (IVC)Carries de-oxygenated blood from lower body to heart
IVC filter:Protect against embolization of thrombus from leg veins (DVT) causing pulmonary embolism (PE)
Two types of filters:• Permanent• Retrievable (SafeFlo)
The Role of an IVC Filter
• Current market >$45 mil.
• Product developed via partnership with Medafor, Inc.
• Introduced in June 2006
New Endovascular Products
SafeSeal™ Hemostasis Patch
New Endovascular Ventures
Chronic Total Occlusion (CTO)• Waterjet enhanced CTO wire• $500 mil. opportunity by 2010
Atherectomy• Waterjet technology to aid atherectomycutting and expedite complete debrisremoval
• $650 mil. opportunity by 2010
Two Products in early R&D phase:
Combined Market Opportunity
U.S Realizable Endovascular Treatment Market Opportunity
AngioJetThrombectomy
Adjunctive Thrombus Management
New Endovascular Treatments
2010 Estimate -- $2.31 billion
$675 m$440 m
$385 m
$1.25 b
$290 m
2007 Estimate -- $790 million
$60 m
1. Increase adoption of AngioJet thrombectomy in our current mechanical thrombectomy markets(Coronary, PAO, AV Access)
2. Expand AngioJet thrombectomyinto new markets (DVT, PE, Neurovascular)
3. Market a growing catalog of thrombus management and other endovascular productsto our established customer network by leveraging our enterprisestrengths
4. Continue worldwide expansion(Europe)
Growth Strategies
• Focus on AngioJet thrombectomy in select markets where opportunity justifies investment
• Leverage recent investments in European clinical research in current and new markets (ie., pulmonary embolism)
• New thrombus management and endovascular products may justify additional investment
Continued Worldwide Expansion
• Product pipeline is full
• Product portfolio includes non-AngioJet products
• New, positive clinical science
• Venous clearance
• Favorable reimbursement
• GPO contracts in place
• Financial strength
• Revitalized and strengthened sales force
• Robust business model
• Easing financial performance comparables
• Growth Plan in place
Stronger Today
An Evolving Investment Story
Development Development High Growth High Growth
Damaged GoodsDamaged GoodsGrowth RecoveryGrowth Recovery
Possis is on the cusp of returning to high growth where plan execution is key.
• 4th qtr. revenue increased 18 percent vs. prior year -and 17 percent sequentially
• Coronary grew 2 percent vs. 4th qtr. last year; first yr. over yr. increase in 12 quarters
• Double-digit sequential coronary, peripheral, and AV growth in 4th qtr.
• Growth driven by new AngioJet Ultra System; catheter usage up 30+ percent so far…
• Generated $2.6 million of positive operating cash flow
4th Qtr. Fiscal 2007 Results
1st Qtr. 2nd Qtr. 3rd Qtr. 4th Qtr.
Revenue (mil.) $15.6 $15.8 $16.2 $19.0
Gross Profit Margin 71.7% 70.0% 68.0% 68.4%
Non-GAAP EPS $0.02 $0.05 $.05 $.03
EPS ($0.01) $0.01 $.00 $.00
Note: Met guidance Q1 & Q2, missed in Q3, exceeded guidance in Q4; four qtrs. sequential & year-over-year quarterly revenue growth.
Fiscal 2007 Highlights
2008 Guidance
12+ Percent Growth
Revenue ($)
$42.5
$57.4
$72.4$65.1 $61.9
$75 est.
$66.7
FY02 FY03 FY04 FY05 FY06 FY07 FY08
$'s Millions
$ 65 $ 75
$ 62
$ 72
$ 67
$4 0
$4 5
$50
$55$6 0
$6 5
$70
$75
$8 0
F iscal 2 0 0 4 A ct ual F iscal 2 0 0 5 A ct ual F iscal 2 0 0 6 A ct ual F iscal 2 0 0 7 A ct ual F iscal 2 0 0 8 Guid ance
Rev
enue
($) M
illion
s
$-$5
$10$15$20$25$30$35$40
Fiscal 2004 Fiscal 2005 Fiscal 2006 Fiscal 2007 Fiscal 2008 YTD
Stock Range (Fiscal Year 2004 - 2008 YTD)
Stoc
k Pr
ice
($) $34.15
$15.01
$30.76
$8.02 $13.39$7.71 $8.28
$14.19
Return To Growth-Comparables Improving
$13.66$9.55