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April 27, 2009
Card Guard AG
Key HigHligHts early mover advantage in a niche and under-penetrated market of wireless telemetry ■
Unlike the fragmented and competitive market of traditional cardiac monitoring services, the wireless telemetry market is still very young and small with mainly Card Guard and CardioNet operating in this field. Although it currently accounts for only 6.5% of the overall cardiac monitoring services market, this share is expected to increase to 50% in mid-term future.
Card Guard has a significant early mover advantage which can be capitalized upon. The Company does not only provide state-of-the-art devices and services but also a strong sales force to reach a large number of physicians and hospitals. This enhances the conversion to the new technology LifeStar ACT and supports Card Guard’s strategy in becoming the leader in cardiac telemetry devices and services.
Change in strategy to focus on lifestar ACt has paid off well in Fy 2008 ■
Since the introduction of the LifeStar ACT services in 2007, Card Guard has revised its strategy to focus predominantly on market development of the wireless telemetry market rather than providing a wide range of products and services for multiple diseases. This change in strategy has paid off well in FY 2008 with a tenfold increase in LifeStar ACT services revenue over FY 2007. Already in Q4 2008, LifeStar ACT contributed to more than 50% of the total revenue indicating a strong potential for these services. LifeStar ACT services are also more profitable and helped the Company post a net profit of 4.7 mUSD in FY 2008 as compared to a loss of 10.8 mUSD in FY 2007. To further communicate the strategic focus of the Company, it has announced its plans to change its name to “LifeWatch AG” in the AGM scheduled for May 26, 2009.
services only model for lifestar ACt ensures recurring revenue and scalability ■
Unlike traditional monitoring services, LifeStar ACT services are provided through an Independent Diagnostic Testing Facility (IDTF) where the Company provides services exclusively through its monitoring facility and not through sales of devices. This business model ensures recurring revenues over a long period of time and helps develop a strong relationship with physicians and hospitals thus ensuring easier scalability.
Company Research
i n t e l l i g e n c e d y n a m i c sresearch & analys is
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strong growth in lifestar ACt services revenue expected in the next couple of years ■
Card Guard expects revenue from LifeStar ACT services to increase rapidly in the next couple of years. This will help the total revenue to grow by more than 50% per annum for at least the next two years from its current base. This is a major turnaround given the fact that revenue had stagnated over the last few years.
Since January 2009 a national Medicare coverage is effective which will enhance the conversion rate from older technologies to the new ACT and increase Card Guard’s profi tability for its provided services.
Revenue composition according to the business segments
3.6
35.840.5 36.0 37.7 38.0 38.343.6
43.2
40.7
52.8
23.010.3 9.3 9.8
11.0 8.1
7.8
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
100.0
FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008
In m
USD
Revenue from LifeStar ACT servicesRevenue from traditional monitoring servicesRevenue from sale of systems
good growth prospects, technological advantage and current low valuation makes Card guard an ideal acquisition target ■
Card Guard, in our opinion could be an ideal acquisition target for a large med-tech company which is eyeing to enter the wireless telemetry market. Card Guard has a substantial customer base and is one of the only two companies in the wireless telemetry services market. The Company has already acquired 26% of the wireless telemetry market within two years and is well placed to exploit the growing market with a strong IP protection (has as many as 41 patents mostly related to wireless cardiac technology). The valuation of Card Guard is also attractive as compared to its closest competitor, CardioNet, as evident from the P/E and P/S multiples.
Comparison point Card guard CardioNetRevenue in 2008 (mUSD) 84.3 120.5
EBIT margin in 2008 13.0% 8.0%
Market cap (mUSD)* 176.8 473.0
P/E* 36.8 74.7
P/S* 2.08 3.95 *as of April 27, 2009
Excellent growth opportunity in
LifeStar ACT services in a wireless
telemetry market of 2 bUSD
Strong IP protectionwith 41 patents and
50 registeredtrademarks
More than 50%cheaper valuation
than its closestcompetitor CardioNet
Strong financialperformance in FY2008 in more than
50% revenue growthwith increase in
marginsAn ideal
acquisitiontarget
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Card Guard AGISIN : CH0012815459
tABle OF CONteNts
1 Company Profile 4
2 Outlook and Projections 4
3 History 5
4 Product Portfolio 5
5 Business Model and Strategy 7
6 Business Model of the LifeStar ACT 8
7 Strategy 8
8 Financial performance 11
9 Shareholding Structure 12
10 Management Profiles 12
11 Market Environment 14
12 Market Sizing 18
13 Wireless Telemetry Services – Growth Engine for a Slow-Growth Market 19
14 Market Forecast 19
15 Competitive Landscape 20
16 Financial Statements 22
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Date of report: April 27, 2009
Core business:Telemedicine services
Exchange: SIX
Stock price as on April 27, 2009: CHF 15.5
52 week high and low: CHF 16.2 – CHF 6.0
Fiscal Year End: Dec 31
Ticker-symbol: CARDG
Shares Outstanding: 12,81 million
Market Cap as at April 27, 2009: 198.5 MCHF
stock performance over 1 year
0
2
4
6
8
10
12
14
16
18
Nov-07 Jan-08 Mar-08 May-08 Jul-08 Sep-08 Nov-08 Jan-08 Mar-09
In C
HF
COmpANy prOFileCard Guard (hereafter referred to as “Card Guard” or “the Company”) is a telemedicine solution provider, specializing in advanced monitoring services for high risk and chronically ill patients especially with heart diseases such as arrhythmia. Card Guard is headquartered in Switzerland and derives more than 90% of its revenue from its wholly owned US subsidiary LifeWatch Corp.
The flagship product of the Company is LifeStar ACT that is used for wireless cardiac telemetry which automatically identifies arrhythmia events and transmits real time data to a monitoring centre. The Company also provides devices and services for the monitoring of indications such as diabetes and pulmonary diseases.
Card Guard has close to 450 managed care contracts covering approximately 280 million lives in the US through relationships with hospitals and physicians. The Company has a monitoring facility headquartered in Rosemont, Illinois which is accredited by various commissions and authorities. The Company employs over 500 people with about 75 in R&D in Israel.
OutlOOK AND prOjeCtiONsCard Guard is well positioned to exploit the 2 bUSD market for cardiac event monitoring services with the new telemetry devices based on its technological advantage, current market presence and limited competition.
The Company aims to double its revenue in the next two years as well as increase its operating margins from 13% in 2008 to as high as 18% by 2010 aided by increased penetration of more profitable LifeStar ACT services. The Company expects to enroll more than 75,000 patients for LifeStar ACT services in FY 2009 which is more than double of that done in FY 2008.
Financial Performance of Card Guard
54.8
84.3
126.6
185.4
11.020.9
33.4
-50
0
50
100
150
200
FY 2007 FY 2008 FY 2009E FY 2010E
In m
USD
Revenue Operating profit
Following our assumptions we expect a high revenue growth of about 50% p.a. in the next two years with a subsequent major impact on the operating profit which we expect to triple from 2008 to 2010. This is based on the one side on the positive market and reimbursement environment and on the other side on the lower operating expenses and higher gross and net margins.
Overall Card Guard presents an attractive opportunity for investors given its strong position in a growing market with a non-cyclical character. The current subdued valuations could also be an additional incentive.
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HistOry1986: Card Guard Scientific Survival Ltd. was incorporated in Israel.
1990: Card Guard started operations with its founding members Yacov Geva, Dan Giora and Leonid Trachtenberg.
1997: Card Guard expanded its sales network in the US and Japan.
1999: The Company went public on the SIX (Swiss Stock Exchange)
2000: Card Guard completed a secondary offering on the SWX. The Company made two acquisitions in the US namely Instromedix, a provider of telemedicine systems and cardiac telemedicine monitoring services and LifeWatch Inc., a provider of cardiac event monitoring, pacemaker and Holter services.
2001: Card Guard moved to new headquarters to Schaffhausen, Switzerland as part of a re-organization. The Company’s listing was moved to the Main Board of SIX. The Company acquired Quality Diagnostic Services (QDS), a US cardiac event monitoring company.
2004: Card Guard signed a long-term agreement with Samsung Electronics to develop, manufacture and sell various medical software applications and devices which will be used in Samsung mobile handsets.
2005: LifeWatch signed an exclusive agreement with Guidant Corporation to provide long-term monitoring services to cardiac patients implanted with a Guidant Implantable Cardiac Defibrillator (ICD).
2007: Card Guard launches a new breed of continuous cardiac monitoring systems, LifeStar ACT.
prODuCt pOrtFOliOCard Guard’s product portfolio encompasses several monitoring devices and services for the diagnosis of various diseases such as hypertension, diabetes and pulmonary diseases. However the Company’s focus is on Cardiology with monitoring devices and services for the diagnosis of arrhythmia. As per the revised strategy, the most important products in the Company’s portfolio are LifeStar ACT and its newest version LifeStar ACT III Platinum.
LifeStar ACT III Platinum is an advanced version of LifeStar ACT which is a remotely programmable auto detect auto send event monitor. The important enhancements in LifeStar ACT III Platinum compared to LifeStar ACT include its proprietary QRS detection methodology in which an advanced algorithm computes the heart rate and detects atrial fibrillation, tachycardia, bradycardia and pause events. Whenever the set parameters are breached, the cellular phone within the system automatically sends the data to the monitoring facility for preliminary analysis and to physician if required.
Card Guard is focusing on the different cardiac monitoring services for arrhythmia especially the wireless telemetry services.
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The other advantages of LifeStar ACT III Platinum are
3 channel ECG for better event monitoring ■
ST deviation analysis for detection of various types of arrhythmias ■
Six hours of memory which prevents data loss in case of unavailability of cellular ■network
Up to 30 days of retrievable ECG memory for minimum data loss ■
A LifeStar ACT III Platinum kit
LifeStar ACT III Platinum was launched in the last quarter of 2008 and it has received a good response in its first three months of launch. Total LifeStar ACT and LifeStar ACT III Platinum enrollments increased by more than five times from 6,132 in 2007 to 31,931 in 2008.
LifeStar ACT Growth in Enrollments
6631,252 1,495
2,722
5,126
7,106
8,545
11,154
0
2000
4000
6000
8000
10000
12000
Q1 2007 Q2 2007 Q3 2007 Q4 2007 Q1 2008 Q2 2008 Q3 2008 Q4 2008
Enro
llmen
ts
LifeStar ACT I LifeStar ACT III
LifeStar ACT III Platinum is the most advanced wireless telemetry services.
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BusiNess mODel AND strAtegyChange in business model from technology and devices developer/provider to a monitoring services provider
Card Guard’s business activities were mainly focused on the development, manufacture and sale of cardiac monitoring devices until 2001. After the advent of the internet, mobile telephony services and increase in regulatory requirements with a jointly improved reimbursement environment made the Company change its strategy from a cardiac monitoring device manufacturer to a patient monitoring service provider.
Revenue Mix
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008
Products and technology Monitoring services
%
The revenue composition of products and technology has consistently decreased since 2001, as can be seen in the chart above. In 2008, monitoring services composed 91% of the total revenue and the share of services in the revenue mix is expected to grow even further in the future. With the introduction of LifeStar ACT (Ambulatory Cardiac Telemetry) in January of 2007, the Company underscored its strategy to only focus on high end and highly profi table cardiac monitoring services and to become the leading company in this fi eld.
Focus on IDTF market and beyond
• Since the launch of LifeStar ACT in 2007,
the Company is focusing on high end continuous cardiac event
monitoring services• The change in strategy
brought a new dimension of high growth and high
profitability to the Company
Services provider
• From 2002 onwards, the Company started
focusing on the cardiac monitoring
services due to advances in technology
and changes in regulatory environment
• With a state-of-the-art technology platform
the foundation for future growth was established
Device manufacturer
• Unil 2001, Card Guard was a leading manufacturer
of cardiac event monitoring devices
• Difficult market and trends: high sales force
power needed, high R&D expenses,
less recurring revenues
Several milestones in this industry were key in Card Guard’s development from devices manufacturer to service provider. The major step was Medicare’s decision in 2002 to increase the regulatory requirements for 24 hour supervision of patients. This enabled the Company to start providing the device as part of a patient monitoring service and build up a complete offering in the service franchise. Although there has already been a high payor acceptance for this service over the last years despite its premium pricing, the fact that a national Medicare coverage through a category 1 CPT code is effective since January 2009 will most probably result in a higher conversion
Change in business model to focus on cardiac monitoring services which is a recurring revenue business.
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rate from older technologies to the new ACT. Finally, Card Guard’s leading role in products and technology innovations was key to becoming the largest, independent diagnostic testing facility (IDTF) provider in the U.S.
BusiNess mODel OF tHe lifestar ACtThe launch of LifeStar ACT in 2007 not only underlines Card Guard’s strategy of becoming the leading wireless ambulatory cardiac telemetry service provider, but also represents a further shift in its business model. The Company does not sell its high-end ACT devices to other monitoring providers. Rather it charges for the services it provides to physicians, hospitals and clinical laboratories. As an approved IDTF for Medicare, the services provided are reimbursed by Medicare at $1’123 per patient but can also qualify for up to $1’500 for commercial payors. This compares favorably to the reimbursement rates of $96 for Holter services and $250 for CEM (older generation technologies).
The higher reimbursed prices for telemedical applications are based on:
An increasing awareness of health insurers (payors) that preventive care is ■signifi cantly cheaper than intensive medical care both in clinic and hospital settings.
The mounting evidence that wireless ambulatory telemetry solutions (ACT) ■provide superior diagnostic outcomes compared to fi rst and second generation technologies like Holter and CEM (Cardiac Event Monitoring).
The wireless cardiac telemetry service model works as follows:
Step 5LifeWatch sends patients' ECG reports to physician
Step 4Patient is monitored on LifeWatch service for up
to 30 days
Step 3LifeWatch hooks up
patient for ACT service
Step 2LifeWatch validates
insurance for ACT coverage
Step 1Physician enrolls patients
on ACT services
Step 6 LifeWatch bills patients'
insurance company
Card Guard gets a technical fee reimbursed of (at least) $1’123 for the ambulatory cardiac event monitoring services it provides in Steps 2 to 6 through its accredited IDTF centers. The professional fee of about $80 is reimbursed to the physician who enrolls the patients in Step 1 and interprets the outcomes of the ECG reports after Step 5.
strAtegyAccording to the 2007 Frost & Sullivan report, Card Guard held already a leading market share position in the U.S. market in 2006. The Company had a 20% share for ambulatory cardiac event monitoring services and a 35% share of the cardiac event monitoring device sales.
The wireless telemetry services model takes care of the entire value chain from patient enrollments to generation of ECG reports.
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Card Guard will capitalize on its solid fundamentals to expand its leading position. To achieve these goals, the Company is focused on:
1 Leverage and expand the strong momentum of LifeStar ACT
2 Increase sales force
3 Convert older technologies to ACT
4 Expand into new disease management services and geographic areas
5 Provide further state-of-the-art technology
1) lifestar ACt – the growth engine for the Company
Since launch in 2007, LifeStar ACT has been the growth engine for the Company with more than tenfold growth in revenue from 3.64 mUSD in 2007 to 35.81 mUSD in 2008. Although the Company generates substantial revenues through pacemaker monitoring, Holter and CEM services, the LifeStar ACT service contributed more than 50% of the Company’s total revenue with record revenue generation of 14 mUSD in Q4/09.
Increase in revenue from LifeStar ACT
11.14 11.71 11.1212.82
14.11
18.7820.37
23.24
24.0022.0020.0018.0016.0014.0012.0010.00
8.006.004.002.000.00
Q1 07 Q2 07 Q3 07 Q4 07 Q1 08 Q2 08 Q3 08 Q4 08
LifeStar™ ACT Cardiac Event and other Holter Pacemaker
10.338.08
3.391.92
+81%
In m
USD
14.01
2) increase sales Force
Card Guard is increasing its sales force rapidly to extend the Company’s reach to a large number of physicians and hospitals and capitalize on the positive momentum of LifeStar ACT. The Company has increased its sales force by more than 70% from 42 in 2007 to 71 in 2008 and expects to increase it to 120 in 2009.
With the increased sales coverage, Card Guard will be able to target physicians and hospitals across the U.S by further extending it’s wide presence in metropolitan and urban centers. In addition, the Company will be able to capitalize on the outsourcing trend. Hospitals and physicians control about 50% of the ambulatory cardiac monitoring market but are outsourcing more and more the service to independent diagnostic testing facilities (IDTF) provider like Card Guard as the reimbursement pressure for older technologies like Holter and CEM persists.
The Company has about 7,000 customers which include 3,900 cardiologists and about 2,100 hospitals. Also the Company has premier US cardiac centers as its clients which include Cleveland Clinic, Johns Hopkins, Columbia University and many more.
LifeStar ACT revenue has grown tenfold from 3.64 mUSD in 2007 to 35.81 mUSD in 2008 and was the growth engine for the Company.
The Company intends to increase its sale force by about 50 people in 2009.
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3) Converting older monitoring technologies to lifestar ACt
The better diagnostic outcome generated with ACT, the favorable reimbursement environment and the well established customer base provide Card Guard with a most favorable precondition to convert older technologies like Holter and CEM to the new ACT. It also enables Card Guard to further accelerate the conversion of “self service” clients to the IDTF “outsourced” model.
Total Solution Platform for Multiple Tests
2008 Enrollments
• 70,359 enrollments• ASP $96
• 122,151 enrollments• ASP $250
• 31,931 enrollments• ASP $1000
Holter
CEM
ACT
Platium
The wireless cardiac monitoring benefi ts all parties involved: the physician, the payor, the patient and the Company. The physician gets a better diagnostic yield with more clinical data; the payor avoids higher costs related to intensive medical care in hospitals through preventive care; the patient gets earlier and better treatment with a convenient solution and the Company gets a 4x higher reimbursement.
4) expand into new disease management services and geographic areas
Card Guard can leverage its comprehensive technology platform, the call center infrastructure and the relationship networks with physicians and insurers to expand on the one side into new chronic diseases areas like diabetes, asthma and obesity, and on the other hand into new markets such eHealth, home health, fi tness and wellness.
In addition Card Guard will increase its regional presence by entering into selected international markets such as European countries. This selective expansion will be based on the reimbursement environment of these countries.
5) provide further state-of-the-art technology
As a leading provider for cardiac event monitoring devices Card Guard will further develop its technology platform to continue delivering tools and applications for modern and cost effi cient health management.
Card Guard is accelerating the conversions of its existing customers of Holter and CEM services to ACT services.
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FiNANCiAl perFOrmANCeCard Guard’s FY 2008 performance was robust in terms of revenue and net profits with revenues increasing by 53.7% from 54.8 mUSD in FY 2007 to 84.3 mUSD in FY 2008 while registering a net margin of 5.6% as compared to loss in FY 2007. The main reason for the sharp rise in revenues was the tenfold increase in revenues from LifeStar ACT monitoring services.
Financial performance of Card Guard
3.6
35.8
43.240.7
8.1 7.8
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
50.0
FY 2007 FY 2008
In m
USD
Revenue from LifeStar ACT services Revenue from traditional monitoring servicesRevenue from sale of systems
The gross margin of the Company was in the range of 45-55% in the last three years, but a clear trend reversal in the operating and net margin can be seen in FY 2008. The operating expenses increased only by about 19.7% as compared to FY 2007 while revenues increased by more than 50% in the same period.
margin analysis Fy 2006 Fy 2007 Fy 2008Gross margin 50.18% 45.40% 53.80%
Operating margin -8.74% -21.35% 13.00%
Net margin 3.38% -19.72% 5.60%
Operating expenses analysisRevenue (mUSD) 54.54 54.84 84.32
Operating expenses (mUSD) 27.85 29.53 35.36
Op expenses as % of revenue 51% 54% 42%
As the Company’s revenues from its highly profitable LifeStar ACT services increased tenfold in FY 2008 compared to FY 2007, the gross margin rose by more than 8 percentage points and also the operating expenses as compared to revenues decreased by about 8% in the same period which helped the Company to achieve a net margin of 5.6%.
The Company had strong cash balance of 22 mUSD as of FY 2008 as compared to 7. 9 mUSD as of FY 2007 due to strong financial performance coupled with sale of marketable securities of 5.6 mUSD and issuance of shares of 3.9 mUSD.
Exponential growth in revenue from highly profitable LifeStar ACT services in 2008.
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sHAreHOlDiNg struCture As of Dec 31, 2008, Card Guard has 12.809 million shares outstanding with a par value of CHF 2.00. Yacov Geva, the Chairman and CEO and Urs Wettstein, Vice Chairman hold together 22.1% of the Company’s shares. The other major shareholders are Archon Capital (4.6%), Dimensional Fund Advisors (1.3%) and Swiss Tech Invest (1.2%). Smaller institutional investors and private investors hold 70.4%.
Shareholding structure as on Dec 31, 2008
Yacov Geva
Archon Capital
Urs Wettstein
Dimensional Fund Adv.
Swiss Tech Invest
Valartis
Others
70.4%
17.8%
4.6%
4.3%
1.3%1.2%
0.4%
In addition, SK Holding AG announced the purchase of 395,900 or 3.1% of Card Guard shares as of Jan 22, 2009.
mANAgemeNt prOFiles management team
yacov geva (Chairman and CeO)
Mr. Yacov Geva is the Chairman and CEO of Card Guard and was also the co-founder of the Company. Prior to Card Guard, Mr. Geva served as a Chief Mechanical Engineer with Vishay Israel, a subsidiary of Vishay Intertechnology, USA, from 1979-1989. From 1976-1979, he was associated with the Koor Industries Group as a special projects manager for electronic communication projects. Mr. Geva is a graduate of the Technion-Israeli Institute of Technology and holds a B.Sc. in Mechanical and Nuclear engineering.
Kobi Ben efraim (CFO)
Mr. Kobi Ben Efraim is the Chief Financial Officer of Card Guard who joined the Company as a Director of Finance & Accounting in Jan 2001. He has more than 20 years of experience in finance and accounting in the Israeli Hi-tech industry. Before joining Card Guard, he was with the DSPC Group for 5 years where he held various positions including Chief Accountant. Mr. Ben Efraim holds a degree in Economics and Accounting from the University of Tel Aviv and is a Certified Public Accountant.
reuven Freudinger (Vp Business Development and global marketing)
Mr. Reuven Freudinger joined Card Guard as Vice President of Business Development and Global Marketing in March 2004. He has extensive overseas marketing and business development experience in the US, Europe and the Far East. Prior to Card Guard, he has served as Executive Vice President for Corporate Strategy and Global Marketing at Hello-Tech Technologies, a company specializing in wireless commercial applications. From 1995 to 2000, Mr. Freudinger was the President and COO at GSIT in the US. He has a graduate degree in Executive Business and Management Program from the Tel Aviv University in Israel.
The management owns 22.1% of the Company shares.
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Brent Atwood (Chief Operations Officer of LifeWatch Services)
Mr. Brent Atwood joined LifeWatch, a US subsidiary of the Company in Dec 2006 and as an Executive Vice President of Sales, he oversees client sales, marketing and business development. Prior to joining LifeWatch, Mr. Atwood was associated with Cerner Corp. for five years. He held several positions in that company from sales and management roles with most senior been the senior executive over National Health Organizations. Mr. Atwood holds a Bachelor Degree in Business Administration.
yair tal (Vp r&D)
Mr. Yair Tal joined Card Guard as Vice President of Research and Development in July 2008. Mr. Tal has over 15 years of strong experience in the R&D projects specializing in hardware, software and very-large-scale systems integration. Prior to joining Card Guard, he held various senior positions at Resolute Networks, Gilat Satellite Networks and LSI. Mr. Tal has an MBA from the Technion, Haifa and a B.Sc.EE from Tel Aviv University.
Board of Directors
Name position BackgroundYacov Geva Chairman of the Board
and CEOBachelors Degree in Mechanical and Nuclear engineering
Urs Wettstein Vice-Chairman Certified Public Accountant and tax consultant
Gregory Henry Volkart Director Auditor with plenty of experience in strategic management consulting
Ruedi Stoeckly Director Expert in investment advisory for international holding companies and tax advice
Dr. Abraham Sartani Director Expert in business and commercial aspects of medicine and drug development
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mArKet eNVirONmeNt Card Guard’s cardiac monitoring devices are used in the diagnosis of cardiac arrhythmia which is caused by abnormal heart beats.
What is cardiac arrhythmia?
A cardiac arrhythmia is an abnormal heart beat caused by changes within the heart which can result due to various reasons such as coronary artery disease, injury from a heart attack, or healing processes after heart surgery. According to the American Heart Association, 850,000 hospitalizations happen due to arrhythmia per year in the US.
Arrhythmias are classified by their rate i.e. speed of heart beat and the area of the heart from which they originate i.e. supraventricular or ventricular. Broadly, arrhythmia can be broken down into the following categories:
1. Atrial fibrillation: The most prevalent arrhythmia is atrial fibrillation which affects about 2.2 million Americans and is characterized by a rapid and irregular quivering of the upper chambers of the heart. According to the American Heart Association, approximately 15-20% of the estimated 850,000 strokes that occur per year in the US are attributable to atrial fibrillation.
2. Ventricular tachycardia: Ventricular tachycardia is a life-threatening arrhythmia which can interfere with the ability of the heart to pump blood and may degenerate into ventricular fibrillation requiring Cardiopulmonary resuscitation (CPR) and defibrillation. It can occur even without an apparent heart disease.
3. syncope: Syncope or fainting can result from an arrhythmia. It is the temporary loss of consciousness because of a sudden decline in blood flow to the brain.
Arrhythmia monitoring market
The arrhythmia monitoring market is divided into two types of treatments
1. Point of care treatment which includes ECG (electrocardiogram) and stress testing services
2. Ambulatory treatment which includes continuous or manual monitoring of cardiac events by Holter, Cardiac Event Monitor (CEM) or wireless telemetry services (remote monitoring).
The point of care treatment is cheaper and can be done quickly in the clinic or hospital. But as Arrhythmia often occurs intermittently or infrequently, the detection of these cardiac events (irregularities) are difficult to monitor because they are unlikely to happen during the clinic visit. Hence the patients are required to be monitored for a long duration of time. The physicians prefer ambulatory monitoring devices such as Holter, CEM or remotely programmable wireless telemetry devices to monitor the patient’s cardiac events.
Cardiac arrhythmia is one of the major cardiac diseases and causes 850,000 hospitalizations per year in the US.
Point of Care services are cheaper than the ambulatory treatments but are less efficient in detection of arrhythmia.
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Cardiac monitoring and ambulatory services market
Point of care treatment
ECG services
Traditional monitoringservices
Srress testing Holter Services
Wirelesstelemetry services
Event monitoring services
Ambulatory treatment
Holter ServicesEvent monitoring
services
Cardiac monitoring landscape
There are three main categories of ambulatory monitoring devices: Holter monitors, event monitors, and wireless telemetry devices. The Holter and event monitors are the traditional devices while the wireless telemetry services are the latest generation and most advanced devices which have seen a robust growth in the recent past.
Holter services
Holter is the most basic ambulatory monitoring treatment which is often the fi rst step in determining an arrhythmia diagnosis and has already been available since the 60’s. The Holter is worn by the patient for 24-48 hours, during which it records the patient’s ECG continuously and storing it on a magnetic tape within the device but without real-time data transfer. The device is then returned to the physician for processing. As the Holter can be worn only for 24-48 hours, they are 90% ineffective in detecting arrhythmia.
event monitoring services
Event monitors are the advanced version of ambulatory monitoring treatment where the data recording can be done for few days but does not have a real time data transfer facility. Event monitor records several minutes of ECG activity at a time and then begins overwriting the memory which is referred as memory loop recording. The memory loop event monitor continuously records and stores the previous 60 seconds of ECG signal in internal loop memory. When a patient becomes symptomatic, he or she manually activates the monitor by pressing the record button which stores the 60 seconds of existing loop memory and an additional 30 seconds of ECG signal following patient activation. Event monitors have limited memory and can store data for less than 10 minutes. The patient has to transmit the event data to the monitoring center by phone.
Event monitors offer certain advantages over Holter as they can be worn up to 30 days, instead of the one to two day period. However, loop event monitors can not capture any of the asymptomatic cardiac events. As only 15% to 20% of clinically signifi cant cardiac events are symptomatic, event monitors can record only those events.
The newer versions of event monitoring devices are called the auto-detect loop event monitor. The auto-detect loop event monitor also records a short memory loop but incorporates basic algorithms that look at irregular heart rates and automatically detect certain asymptomatic arrhythmias. Auto-detect auto-send (ADAS) loop event monitors have the ability to send captured event data to a monitoring center via cell phone automatically.
Cardiac monitoring landscape is continuously evolving with technology advancements and better detection techniques.
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shortcomings in the traditional monitoring services
The shortcomings of the traditional monitoring services are
1. Inability to detect asymptomatic events due to manual recording of the cardiac events except the auto-detect event monitors
2. Failure to provide real-time data due to lack of data transfer facility
3. Data storage constraints
4. Suboptimal diagnostic yields adversely impacting clinical outcomes
Due to the above mentioned shortcomings of the traditional monitoring systems, the new breed of monitoring services were developed which have the ability of real time data transfer and large storage capacity called wireless telemetry services.
Wireless telemetry services
Wireless telemetry services are the most advanced version of the cardiac monitoring services where the event monitor can auto detect and auto send the information through a cellular connection to the monitoring facility i.e. an independent diagnostic testing facility (IDTF). These devices are equipped with enough memory to record data for few hours or days. These devices can be remotely programmable and hence the patient can plug the device on his or her body and an IDTF takes care of the monitoring remotely.
The main advantage in these monitoring services is the fact that they don’t require physician’s attention in the monitoring period. The IDTF is responsible for the entire process of monitoring from patient enrollment and confirming his/her insurance schemes till the time it provides the detailed report to the physician after the monitoring period is over.
Currently Card Guard and CardioNet are by far the largest providers of wireless telemetry services in the US through their products LifeStar ACT and MCOT respectively.
The table below shows the evolution of the monitoring systems and their specifications.
Holter event monitoring
Wireless telemetry services
Timing of Market Introduction 1960 1999 2007*
24–48 Hour Monitoring Y Y Y
20–30 Day Continuous Y Y
Monitoring Y Y
Manual Trigger Y Y
Auto Detect Y Y
Auto Send Y
Remotely Re-programmable Y
Average Reimbursement USD 96 USD 250 USD 1,000 and more
Data Storage 24 hours Up to 180 seconds
Up to 30 days
Data transmission Manual transmission through returning device to physician
Telephonic transmission
Cellular transmission
Average Diagnostic Yield 6% 18% 80%
*LifeStar ACT was introduced by Card Guard in 2007
Wireless telemetry services are remotely monitored auto detect auto send event monitoring which addresses the shortcomings of the traditional monitoring services.
Average diagnostic yield of the wireless telemetry services is very high as compared to Holter and Event monitoring.
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As can be seen in the table above, the average diagnostic yield of the wireless telemetry service is way higher than that of Holter and CEM which means that there is a significant superior diagnostic outcome with the new devices. This fact is also the reason why payors are willing to reimburse a 4 times higher price for these services provided.
revenue model of different cardiac monitoring services
The wireless telemetry services have a revenue model different to that of Holter and Event monitors. The revenue generated from the wireless telemetry services is exclusively based on services and developing relationship with the physicians and hospitals. As wireless telemetry services providers such as Card Guard take care of the entire value chain from enrolling the patient to continuous monitoring to claiming the medical reimbursement, the much higher prices for the services are justified. Although Card Guard does not sell the newest LifeStar ACT devices, the revenues it can generate through the complete monitoring services it provides are much more profitable. The ACT device has a life-span of 3-5 years and generates therefore recurring revenues to the company during this period.
Business model reimburse-ment per test
revenue model growth prospects
HolterProduct sales to the physicians and the services are provided on the revenue sharing basis
USD 96 The revenue is generated mostly through a product sale with small services revenue. Mostly the revenues are not recurring after the sale of a device
Stable or declining growth prospects as the reimbursements for older tests are declining. Still it is a very important segment as this is the predominantly used test for monitoring cardiac events
event monitorsProduct sales to the physicians and the services are provided on the revenue sharing basis
USD 250 The revenue is generated mostly through a product sale with small services revenue. Mostly the revenues are not recurring after the sale of a device
Limited growth prospects as the advanced versions of event monitoring devices are being developed. The segment is important as there can be significant conversions of these patients to remote event monitoring services
Wireless ambulatory telemetryOnly services are provided through an IDTF with no product sales
USD 1000 and above
The revenue is only generated from services provided. Revenue is mostly recurring once the relation with the physician or hospital is developed.
High growth prospects as this is the most advanced cardiac monitoring service. The IDTF gets about 80% or more of the total reimbursement. It generates far more revenues for the company per test as compared to Holter and Event monitors.
The revenue from wireless telemetry is only services based and hence mostly recurring once the relation with the physician is developed.
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mArKet siziNg More than 4 million US citizens are affected by Arrhythmia and the total number of cardiac monitoring tests performed every year is approximately 60 million which accounted for a market size of 2 bUSD for the cardiac monitoring services. Around 80% of these tests are point of care tests while about 20% are ambulatory tests. But on a revenue basis, 65% revenue is generated from point of care treatments and about 35% from ambulatory as payments for ECG and stress tests are lower than ambulatory tests.
Maket Composition of Cardiac Monitoring Services
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
20%
80% 65%
35%
Number of tests Revenue distribution
Point of care tests Ambulatory tests
In m
USD
Source: Frost and Sullivan
Card Guard is mainly operating in the market for wireless telemetry services (i.e. the services provided through LifeStar ACT) which has currently a market size of about 136 mUSD i.e. approximately 6.5% of the overall cardiac services market (source: Frost and Sullivan). This market space is dominated by only two companies – Card Guard and CardioNet with their products LifeStar ACT and MCOT respectively. CardioNet has 74% of the wireless telemetry market and Card Guard has the remaining 26%.
Market sizing for wireless telemetry services in 2008 in USD mn
All traditional services such as ECG, Holter and Event monitoring Card Guard’s
LifeStar ACT
Cardionet’sMCOT
Wirelesstelemetryservices
136
36
1001,870
Wireless telemetry services currently contribute only 6.5% to the overall monitoring market. Card Guard and CardioNet, only two major companies, operate in this market.
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WireLeSS TeLemeTry ServiCeS – GrOWTh enGine fOr A SLOW-GrOWTh mArkeTIn the last several years, the cardiac monitoring services market has seen a slow growth rate of about 3% due to lack of new technology development, a highly fragmented market and reimbursement pressure from insurance companies. Despite of this slow growth, the market forces such as increasing demand due to demographic changes, attractive reimbursement rates for advanced technologies and need for an outsourcing facility to save physician’s time were always intact.
Since the wireless telemetry services have been introduced by Card Guard and CardioNet, they have got satisfactory acceptance from the physicians and good reimbursement rates from the insurance companies. Hence they have contributed a significant portion to the overall growth of these companies.
The chart below depicts the growth in revenue for wireless telemetry products for Card Guard and CardioNet in 2008. While the overall market was growing at a stable rate of about 3%, the growth rate for the wireless telemetry services was 176% in 2008 over 2007.
Growth in wireless telemetry revenue in 2008
45.6
100.23.64
35.81
0
20
40
60
80
100
120
140
160
2007 2008
In m
USD
Cardionet's MCOT Card Guard's LifeStar ACT
49.24
136.01
176%
growth
mArKet FOreCAstWireless telemetry services currently contribute only 6.5% to the overall cardiac monitoring services market and according to Card Guard, this ratio is expected to increase to 50% leading to a nine fold increase in the market for wireless telemetry services in the midterm future. Also we expect the overall market size of the monitoring services will increase by 5% on average p.a. for next few years based on the robust growth in the wireless telemetry services offset by the decline in the market for traditional services due to reimbursement pressure as well as conversion to the wireless telemetry services.
Wireless telemetry revenue grew by 176% in 2008 over 2007 as compared to only 3% growth in the overall monitoring market in the same period.
Contribution of wireless telemetry revenue is expected to increase from 6.5% in 2008 to 50% in mid-term future.
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As currently there are only two companies in this market space, both Card Guard and CardioNet will have the first movers’ advantage and are expected to gain from the huge increase in the market size.
Future estimation of cardiac monitoring services
2008
In m
USD
Traditional cardiac monitoring services Wireless telemetry services
3000
1864
1250
1250
136
2500
2000
1500
1000
500
0
in mid -term future
COmpetitiVe lANDsCApe The overall cardiac monitoring services market is fragmented with many companies competing hard for market shares thus reducing the margins. But the wireless telemetry services market, a so far niche segment is a duopoly with Card Guard and CardioNet as the two companies operating in that space. Hence the most important competitor for Card Guard is CardioNet which is profiled below.
CardioNet
CardioNet is a US company which provides continuous, real-time wireless telemetry services for arrhythmia. The company provides diagnostic services for cardio vascular diseases through its flagship product- Mobile Cardiac Outpatient Telemetry™ (MCOT™) as well as through Event monitoring and Holter services. The Company got listed on NASDAQ with its IPO in March 2008.
MCOT, the wireless telemetry service received FDA 510(k) clearance for its first and second generations in 2002. CardioNet started a monitoring center in Pennsylvania in July 2002 and has released its third generation of MCOT (“C3”) in December 2007. The C3 generation MCOT device includes the following enhancements over previous generations.
Reduction in size so easy to use ■
Increased radio transmission strength which allows greater mobility ■
Enhanced graphical interface to be more patient friendly ■
As Card Guard’s LifeStar ACT III and CardioNet’s MCOT are the only two most advanced services competing in the wireless telemetry services market space. The table below depicts the main features and differences between the two devices.
CardioNet is the closest competitor of Card Guard with its flagship product MCOT.
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product comparison table
Feature lifestar ACt iii mCOt CommentsType of ECG 3 Channel ECG 2 Channel
ECG3 Channel ECG is better in recording cardiac irregularities than the 2 Channel ECG
Sensor memory 6 hours No memory Sensor memory is important to store the event data in case of no cellular connection for small time duration
Battery life 10 days 24 hours More number of batteries are required for MCOT
Cellular transmission Through any STD cellular phone
Specific phone developed for this application
Low dependency on the cellular connection in case of LifeStar ACT. Also MCOT had a huge development and manufacturing cost for the phone
ST deviation Using NEB configuration
For arrhythmia only
Better technology used in LifeStar ACT
The following table compares the two companies in terms of financial multiples and valuations
Company comparison table
Comparison point Card guard CardioNetRevenue (in mUSD) 84.3 120.5
EBIT margin 13.0% 8.0%
Sales force 71 88
Managed care/ Billing 445 contracts – 278 million covered lives
199 contracts – 190 million covered lives
Market cap (mUSD)* 176.8 473.0
P/E* 36.8 74.7
P/S* 2.08 3.95*as of April 27, 2009
The other companies providing wireless telemetry services but not direct competitors to Card Guard are as follows:
Biowatch medical: Biowatch Medical is a private company which offers Vital Signs Transmitter (VST). VST provides continuous, real time, wireless ambulatory patient monitoring of two ECG channels plus respiration and temperature. The VST monitor incorporates large-scale-integrated circuitry packaged in a belt-assembly worn around the patient’s chest without adhesive electrodes. VST requires manual data transmission on activation by the patient or by the monitor’s real-time analysis software.
sHl telemedicine ltd.: SHL Telemedicine is an Israeli company which is specialized in developing and marketing advanced personal telemedicine systems as well as providing end-users with telemedicine services including medical call center services with a focus on cardiovascular and related diseases. SHL is the market leader in Israel and also has a presence in Germany, through a wholly owned subsidiary and in the US through a distribution by Philips Healthcare. The CardioSen’C™, the company’s product is a personal cellular-digital 12 lead ECG transmitter which transmits to medical call centre for the remote diagnosis of arrhythmia and other heart diseases.
As SHL is mainly operating in Israel and some European countries, it will not be a direct competitor to Card Guard till it expands beyond US.
LifeStar ACT III Platinum is more advanced and efficient as compared to MCOT
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FiNANCiAl stAtemeNts income statement
12 months ending Dec. 31, 3 months ending Dec. 31, USD in thousands (except per share data)
FY 2007 FY 2008 Q4 2007 Q4 2008
Sales of Systems 8,051 7,822 1,955 1,596
Services 46,793 76,507 12,823 23,239
total revenues 54,844 84,329 14,778 24,835Cost of revenues 29,952 38,945 7,560 11,303
Gross profit 24,892 45,384 7,218 13,532Research & development expenses, net *
4,369 4,878 1,051 1,008
Selling and Marketing expenses
12,380 16,123 3,040 4,959
General and administrative expenses
12,782 14,362 3,942 3,550
Costs associated with re-structuring and other
7,072 -950 - -
total operating expenses 36,603 34,413 8,033 9,517Profit (loss) from operation -11,711 10,971 -815 4,015Financial expenses, net -466 -1,034 -216 -416
Other income, net 349 619 - 614
Profit (loss) before taxes on income
-11,828 10,556 -1,031 4,213
Tax (expenses) benefit on income
895 -5,840 -307 -1,411
Equity income 117 1,038 -
Net income (loss) for the period
-10,816 4,716 -300 2,802
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Balance sheet
usD in thousands Fy 2007 Fy 2008 Audited unaudited Assets Cash and cash equivalents 7,861 21,996
Marketable securities and structures 2,605 261
Accounts receivable (trade & other), net 9,073 14,690
Deferred income taxes 1,403 4,716
Inventories 4,926 4,981
total current assets 25,868 46,644Marketable securities and structures 5,175 1,780
Other investments & non-current receivables (trade & others) 9,620 1,382
Total investment and non-current receivables 14,795 3,162
Fixed assets, net 8,309 11,999
Goodwill, intangible and other assets, net 15,954 15,296
total assets 64,926 77,101
liabilities and shareholders’ equity Short-term credit from a bank and others 3,176 3,890
Current maturities of long-term loans and other liabilities 5,008 5,488
Accounts payable and accruals (trade and other) 12,858 16,890
total current liabilities 21,042 26,268Loans and other liabilities, net of current maturities 7,037 4,977
Liability for employee rights upon retirement, net 176 105
total long-term liabilities 7,213 5,082total liabilities 28,255 31,350
Share capital, warrants, treasury stock & capital surplus 151,186 155,550
Accumulated deficit -103,699 -114,515
Net income (loss) for current year -10,816 4,716total shareholders’ equity 36,671 45,751total liabilities & shareholders equity 64,926 77,101
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Cash Flow statement
usD in thousands Fy 2007 Fy 2008CASh fLOWS frOm OPerATinG ACTiviTieS: Net income (loss) for the period -10,816 4,716
Adjustments required to reconcile net income (loss), for the
period to net cash provided by operating activities:
Income and expenses not involving cash flows:
Depreciation and amortization 7,457 4,324
Amount charged in respect of warrants granted 711 530
Capital gain from sale of associated company - -612
Change in deferred income tax, net -1,679 4,811
Changes in operating assets and liabilities:
Decrease (increase) in accounts receivable 2,475 -5,396
Share in losses of an associated company -116 -
Increase in inventories -119 -55
Increase (decrease) in marketable securities -65 272
Increase (decrease) in accounts payable, others -267 1,301
Net cash provided by (used in) operating activities -2,419 9,891CASh fLOWS frOm inveSTinG ACTiviTieS: Purchase of fixed assets -5,454 -4,335
Proceeds from sale of associated company - 712
Purchase of marketable securities and structures -5,575 -200
Proceeds from sale and maturity of marketable securities 9,387 5,577
Restricted bank deposit -195 -111
Investment in investee company -750 -
Purchase of other assets -30 -50
Net cash provided by (used in) investing activities -2,617 1,593CASh fLOWS frOm finAnCinG ACTiviTieS: Issuance of share capital, net 853 3,912
Release of treasury stock 4 8
Obligations under capital leases undertaken 3,328 3,751
Discharge of long term loan - received from a bank -2,084 -2,827
Discharge of obligations under capital leases -2,248 -2,715
Long-term loan received 1,666 211
Short term loans, net 750 714
net cash provided by (used in) financing activities 2,269 3,054translation differences on cash balances of subsidiaries 1 -403increase (decrease) in cash and cash equivalents -2,766 14,135Balance of cash and cash equivalents at beginning of period
10,627 7,861
Balance of cash and cash equivalents at end of period 7,861 21,996