Attached files
file | filename |
---|---|
8-K - FORM 8-K - CAMBRIDGE HEART INC | d8k.htm |
Investor
Presentation June 7, 2010
Exhibit 99.1 |
Forward Looking
Statements 2
Statements in this presentation that are not purely historical are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995 including, but not
limited to, statements about existing and potential partnerships and distribution
arrangements that Cambridge Heart, Inc. (the Company) is, or may become party to,
statements about the Companys expected launch of the MTWA Module by Cardiac Sciences
Corporation, future operating results, the Companys belief that the Companys existing
cash resources are sufficient to fund operations through March 31, 2011, the Companys
expectations and estimates regarding MTWA Module metrics (i.e., MTWA Module and sensor sales
prices, gross margins and sensor utilization), and product development plans. These
forward-looking statements are based on current expectations and assumptions that are
subject to risks and uncertainties. Actual results could differ materially from the
results expressed or implied in these forward-looking statements. Material deviations
from our current operating plan, including a delay in launching the MTWA Module, lower than
expected sales of the MTWA Module, lower than expected sales of the Heartwave II System, lower than
expected sales prices or gross margins for the MTWA Module and lower than expected sensor utilization by
purchasers of the MTWA Module, may cause or contribute to such differences. Other factors
that may cause or contributed to such differences include failure to achieve broad market
acceptance of the Companys MTWA technology, failure of our sales and marketing
organization or partners to market our products effectively, inability to hire and retain
qualified clinical applications specialists in the Company's target markets, failure to
obtain or maintain adequate levels of first-party reimbursement for use of the Company's MTWA
test, customer delays in making final buying decisions, decreased demand for the Company's
products, failure to obtain funding necessary to develop or enhance our technology, adverse results in
future clinical studies of our technology, failure to obtain or maintain patent protection for
our technology and overall economic and market conditions. Many of these factors are
more fully discussed, as are other factors, in Part I, Item 1A. Risk Factors of
the Companys Annual Report on Form 10 K for the fiscal year ended December 31, 2009,
which is on file with the SEC and available at www.EDGAR.com. In addition, any
forward-looking statements represent our estimates only as of today and should not be relied upon as
representing our estimates as of any subsequent date. While the Company may elect to update
forward- looking statements at some point in the future, the Company specifically disclaims
any obligation to do so except as may be legally necessary, even if the Companys estimates
should change. |
Corporate
Mandates Impact the number of deaths from sudden
cardiac arrest (SCA) from todays 300,000
400,000 annual incidents
Make MTWA testing a standard annual
diagnostic assessment of ~12 million high-risk
cardiac patients
Leverage MTWA core technology into new,
broader-based diagnostic cardiac applications
3 |
The
Opportunity New business model, major risks eliminated, attractive
valuation
Key components for success in place
Large addressable market of ~ 12 million high risk cardiac patients
FDA Clearance
CMS and private reimbursement in place
Significant IP and clinical validation
New marketing partnership set to commence
Recurring revenue stream builds shareholder value
Razor/razor-blade model
High-margin disposables
4 |
Overview &
Milestones 1980s: Early research at MIT
1990: CHI was founded
1994: Landmark publication in NEJM
1996: Initial public offering (CAMH)
1996: First 510(k) & CH2000 launch
1999: Regulatory study completed & received FDA labeling claims
2000: HearTwave
I launch
2005: HearTwave
II launch
2006:
NCD
by
CMS,
Class
II-a
Guideline,
Coverage
by
many
private
payers
2007
2008: Co-marketing agreement with SJM
2009:
Agreement
with
Cardiac
Science
Corporation
to
develop
and
market
an Alternans module for integration into existing stress platform
2010: MTWA OEM Module 510(k)
5 |
High SCA Risk
Population: Large US Market Opportunity
5 million
Heart Failure
1-2 million
other
8 million
Post MI
~ 12 million
high-risk
individuals
Circulation 2/10/2006 Heart Disease and Stroke Statistics
300,000
400,000 deaths per year
6 |
Microvolt
T-Wave Alternans (MTWA) More effective at
identifying at-risk SCA
patients than invasive
electrophysiology (EP) test
Extraordinary negative
predictive value (NPV)
Ensure delivery of
appropriate therapy
HearTwave®
II
7 |
The
Technology MTWA
Analytic Spectral Method
13 patents protect all components of the technology
Even Beats
Odd Beats
Mean
V
alt
V
alt
Q
R
S
T
8 |
Clinical
Validation 200+ publications in peer-reviewed journals
Large prospective clinical trials
ALPHA Study -
Boston Scientific
ABCD Study
St. Jude Medical
MASTER Study --
Medtronic
Ikeda Study
Meta
Analysis
Hahnloser
(March
2009
HRS
Supplement)
Applicable patient populations
Primary
prevention
(ejection
fraction
35%)
Post MI
Congestive heart failure
Syncope
Dilated cardiomyopathy
9 |
Class IIa
Guideline
American College of Cardiology/American Heart Assoc./European Society of
Cardiology 2006 Guideline for Management of Patients With Ventricular
Arrhythmias and the Prevention of Sudden Cardiac Death (Developed in
collaboration with the HRS and EHRA)
Class IIa
It
is
reasonable
to
use
T-Wave
Alternans
for
improving
the
diagnosis
and
risk
stratification
of
patients with ventricular arrhythmias or who are
at risk for developing life-threatening ventricular
arrhythmias. (Level of Evidence: A)
10 |
CMS National
Coverage CMS (Medicare) has determined that there is
sufficient evidence to conclude that Microvolt T-
wave Alternans (MTWA) diagnostic testing is
reasonable and necessary
for the evaluation of
patients at risk of sudden cardiac death, only
when the spectral analytic method*
is
used, and CMS is issuing the following national
coverage determination (NCD) for this
indication.
93025 (3/21/2006)
* Cambridge Heart US Patent # 6,735,466 granted May 2004
11 |
Medicare
Reimbursement National Average: $196
Reimbursement is limited if MTWA is performed at
the same time as standard stress, stress echo or
nuclear stress testing
Negatively impacts physicians ability to integrate
MTWA testing for high-risk cardiac
patients
CHI has requested that CMS remove the current
limitations
A positive outcome would provide full reimbursement
for both stress and MTWA tests during the same
patient visit
12 |
Private
Coverage Private payers followed CMS:
Aetna, Cigna, Humana
HCSC, BC/BS of NY, Horizon (NJ), Care First, MI, IA, SD,
MN, KS, Wellmark, Premera, BCBS of AZ
Harvard Pilgirim
Regionals: GHI, Tufts, Med. Mutual of Ohio, Health Net
Coverage typically for ICD indicated population
Other private payers in progress
13 |
Initial Market
Positioning 14
Historical clinical positioning and marketing
linked MTWA testing to ICD therapy
That positioning limited the market opportunity
and perception of MTWA testing
300,000 to 1 million primary prevention patients
Focus on EP community and testing of border line patients
Entanglement in clinical disagreements on ICD therapy
Additional Challenges
Relatively expensive, stand-alone MTWA equipment platform
Single product offering and inability to offer a complete
solution;
Practice integration issues
Lack of distribution
Economic environment for medical capital equipment |
New Strategic
Direction Position MTWA as a tool to
assess and manage
an individuals risk of SCA in the high risk
population
Make MTWA more accessible to the high risk
population
Develop multiple product embodiments and industry partnerships
Create an attractive physician ROI
Simplify practice integration
Re-organize resources on the primary corporate
value driver (i.e. sensor utilization)
15 |
SCA Risk
Management in Preserved EF Population
Non-device interventions for reducing SCA risk
Adapted from Myerburg, NEJM 2009; 360(9):938. |
300,000
1,000,000 primary
prevention population
Reluctant / borderline
Patients
New Strategic Direction
~ 12 million
post MI, HF
and other high
risk patients
~ 40,000,000
Cardiac stress tests per year |
OEM Alternans
Module Taps into existing market for stress systems
Approximately 4,000 units sold per year (1)
with
an estimated
installed base of 35,000. 40 million tests performed per year.
Key players: CSC (39%), GE (30%), Welch Allyn (6%) Schiller
(5%), Mortara
& Philips (4% combined)
(1)
Materially improves physician ROI
Reduces technology acquisition costs
Maximizes reimbursement
Significantly simplifies practice integration
Simplified training
Simplified EMR connectivity
(1) Source: Frost & Sullivan, 2009 Report. US market data only.
18 |
First
Partnership Signed Cardiac Science: US stress market leader
5 year, non-exclusive, worldwide
Partner will market and sell modules and sensors (CHI to drive
utilization)
Module end-user pricing in-line with other stress upgrades/options ($5-$8k).
End-user sensor pricing in-line with current CHI of $64 to $84 per sensor.
Partner will sell directly to the end-user and retain a portion of the
revenue.
Module will be offered as an upgrade to:
Partners existing installed base of stress systems
Partners new system sales
Product Launch
Q3 2010
Module development (CHI & CSC)
Completed in February 2010
Regulatory requirements
510(k) received in April 2010
Marketing & sales training
On-going
19 |
2010 Strategic
Initiatives MTWA Module
Other Stress Platforms
CHIs
current development work is portable to other manufacturers cardiac
stress platforms
MTWA Module
Other embodiments
Ambulatory Holter
platform
Event recording services
Pacemaker programmer
Heartwave II System
Independent/corporate distribution networks
Geography not covered by CHIs
existing direct sales force.
20 |
2010 Strategic
Initiatives Ischemia Application
Data suggest MTWA can identify ischemia missed by current tests
Pilot study to begin in July 2010
PI identified
Protocol completed
IRB approval in progress
MTWA and Pharmacological Agents
Drug development phase
Resuscitation of failed drugs
Individualized medicine
21 |
The Market
Opportunity Disposable sensor gross margin in excess of 70%
COGS reductions opportunity based on volume
10% Penetration of ~12 million high risk patients:
$60 Million in annual recurring revenue from the sale of
proprietary sensors
25% Penetration of ~12 million high risk patients:
$150 Million in annual recurring revenue from the sale of
proprietary sensors
22 |
MTWA Module
Metrics Upfront Module Revenue
$1,000 -
$5,000 (platform/channel dependant)
70% -
90% gross margin
Recurring Sensor Revenue
$35 -
$70 per MTWA test (platform/channel dependant)
+70% gross margin
Possible Range of Sensor Utilization/System
70 to 140 sensors/system/year
23 |
Cash Flow
Summary Current Quarterly Revenue -
$800,000 +
20%
U.S. HearTwave
Systems
U.S. Sensor revenue
All other (includes service and ROW sales)
Quarterly Cash Expenditures -
$1,900,000
Largely fixed cash expenditures except commissions and minimal COGS
Quarterly Cash Burn -
$1,100,000 plus CAPEX
Cash at March 31, 2010
$2.2 million
Coupled with proceeds of $2 mm from exercise of Series D Warrants, the
Company believes is sufficient to fund operations through Q1 2011
24 |
Capital
Structure Series C-1 Convertible Preferred (SJM Mar 2007)
$12.5 million junior liquidation preference
Converts into 4.2 million common shares at $2.99
Series D Convertible Preferred (Dec 2009)
Purchased by directors and existing individual and institutional
shareholders
$1.8 million senior liquidation preference
Converts into 22.6 million common shares at $0.082
Short-term warrants to purchase 11 million common shares at
$0.107 (expires 12/31/10); and long-term warrants to purchase 7
million common shares at $0.142 (exercised as of 6/4/10)
Capital Structure (on as converted and exercised basis)
111 million common shares issued and outstanding
9 million employee/director options (7 mm at $0.16 exercise price)
25 |
The
Opportunity New business model, major risks eliminated, low valuation
Key components for success in place
Large addressable market of ~ 12 million high risk cardiac patients
FDA Clearance
CMS and private reimbursement in place
Significant IP and clinical validation
New marketing partnership set to commence
Recurring revenue stream builds shareholder value
Razor/razor-blade model
High-margin disposables
26 |
Investor
Presentation June 7, 2010 |